Posts Tagged ‘Cleveland Clinic’

Patients First

Larry H. Bernstein, MD, FCAP, Curator



Office of Patient Experience



Cleveland Clinic defines our patient experience as putting “Patients First”.



Putting patients first requires more than world-class clinical care – it requires care that addresses every aspect of a patient’s encounter with Cleveland Clinic, including the patient’s physical comfort, as well as their educational, emotional, and spiritual needs. Our team of professionals serves as an advisory resource for critical initiatives across the Cleveland Clinic health system. In addition, we provide resources and data analytics; identify, support, and publish sustainable best practices; and collaborate with a variety of departments to ensure the consistent delivery of patient-centered care.

Cleveland Clinic was the first major academic medical center to make patient experience a strategic goal, appoint a Chief Experience Officer, and one of the first to establish an Office of Patient Experience.


Patient Experience Measurement


How We Measure Patient Experience

All acute care hospitals throughout the United States participate in a patient survey process designed and regulated by the Centers for Medicare and Medicaid Services (CMS). This HCAHPS survey (Hospital Consumer Assessment of Healthcare Providers and Systems) measures patients’ perspectives of their hospital care.

Public results are available at hospitalcompare.hhs.gov. Eligible adult patients are surveyed after hospital discharge and results displayed represent four consecutive calendar quarters.

Due to a time lag of the published HCAHPS survey results, we believe it is important for you to see our most recent feedback. View our HCAHPS scores from the last public reported period as well as our recent performance.

HCAHPS Education and Data Coordination

The Intelligence Team in the Office of Patient Experience plays a vital role in coordinating survey data transmission between the survey vendor and the Cleveland Clinic system. Real-time survey results, complete with benchmark comparisons and performance indicators, are maintained on an internal web-based dashboard program available to all staff in leadership and management roles. The team also provides survey education, particularly for the CMS-required inpatient HCAHPS survey process, and works together with leadership to uncover feedback trends and help prioritize experience improvement efforts.


Patient Experience: Empathy & Innovation Summit

Patient Experience: A Key Differentiator

Patient experience has emerged as a dynamic issue for healthcare executives, physicians, nursing executives and industry leaders. No provider can afford to offer anything less than the best clinical, physical and emotional experience to patients and families. As patients become savvier, they judge healthcare providers not only on clinical outcomes, but also on their ability to be compassionate and deliver excellent, patient-centered care.

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Eric Topol, M.D., Gary & Mary West Endowed Chair of Innovative Medicine, Scripps Research, Executive VP, Scripps Research, Ex-Chairman of Cardiovascular Medicine at Cleveland Clinic and Founder of the Cleveland Clinic Lerner College of Medicine

Curators: Larry H Bernstein, MD, FCAP and Aviva Lev-Ari, PhD, RN

Eric Topol, M.D. is professor of genomics and holds the Scripps endowed chair in innovative medicine. He is the director of the Scripps Translational Science Institute in La Jolla, California. Previously, he led the Cleveland Clinic to its #1 ranking in heart care, started a new medical school, and led key discoveries in heart disease.

Professor of Genomics
Department of Molecular and Experimental Medicine
California Campus
Laboratory Website
(858) 554-5708

Scripps Research Joint Appointments

Director, Scripps Translational Science Institute
Faculty, Graduate Program

Other Joint Appointments

Chief Academic Officer, Scripps Health
Senior Consultant, Scripps Clinic, Division of Cardiovascular Diseases

Research Focus

My research is on indvidualized medicine, using the genome and digital technologies to understand each person at the biologic, physiologic granular level to determine appropriate therapies and prevention. An example is the use of pharmacogenomics and our research on clopidogrel (Plavix). By determining the reasons for why such a large proportion of people do not respond to this medication, we can use alternative treatment strategies to prevent blood clots.



M.D., University of Rochester, New York, 1979
B.A., Biomedicine, University of Virginia, Charlottesville, 1975

Professional Experience

University of Virginia, B.A. With Highest Distinction, 1975
University of Rochester, M.D. With Honor, 1979
University of California, San Francisco, Internal Medicine Residency, 1979-1982
Johns Hopkins, Cardiology Fellowship, 1982-1985
University of Michigan, Professor with Tenure, Department of Internal Medicine, 1985-1991
Cleveland Clinic, Chairman of the Department of Cardiovascular Medicine, 1991-2006
Cleveland Clinic, Chief Academic Officer, 2000-2005
Cleveland Clinic Lerner College of Medicine,Founder and Provost
Case Western Reserve University, Professor of Genetics,2003-2006

Awards & Professional Activities

Elected to Institute of Medicine, National Academy of Sciences
Simon Dack Award, American College of Cardiology
American Heart Association, Top 10 Research Advances (2001, 2004)
Top 10 Most Cited Researchers in Medicine, Institute for Scientific Information
Doctor of the Decade, Thompson Scientific Award

Selected References

Goetz L, Bethel K, Topol EJ. Rebooting cancer tissue handling in the sequencing era. JAMA 309: in press, 2013

Harper AR, Topol EJPharmacogenomics in clinical practice and drug developmentNature Biotechnology, 2012 Nov;30(11):1117-24. [PMID: 23138311]

Komatireddy R, Topol EJ. Medicine Unplugged: The Future of Laboratory Medicine. Clin Chem. 2012 Oct 15. [PMID: 23071365]

Harismendy O, Notani D, Song X, Rahim NG, Tanasa B, Heintzman N, Ren B, Fu X-D, Topol EJ, Rosenfeld MG, Frazer KA. 9p21 DNAvariants associated with coronary artery disease impair interferon-c signalling response. Nature470(7333):264-268, 2011. [PMID 21307941]

Bloss CS, Schork NJ, Topol EJEffect of Direct-to-Consumer Genomewide Profiling to Assess Disease RiskNew England Journal of Medicine 364(6):524-534, 2011. [PMID 21226570]

Topol EJ, Schork NJ. Catapulting clopidogrel pharmacogenomics forward. Nature Medicine 17(1):40-41, 2011. [PMID 21217678]

Rosenberg S, et al, Topol EJ; PREDICT Investigators. Multicenter validation of the diagnostic accuracy of a blood-based gene expression test for assesing coronary artery disease in nondiabetic patients. Annals of Internal Medicine153(7):425-434, 2010. [PMID 20921541]

Topol, EJ. Transforming Medicine via Digital Innovation. Science Translational Medicine 2(16):16cm4, 2010. [PMID 20371472]


The wireless future of medicine


FinanciaPost‘s Digital revolution in antiquated health-care industry a major operation

Listen to Dr. Topol’s podcast interview with Knowledge@Wharton

In his new book, The Creative Destruction of Medicine: How the Digital Revolution Will Create Better Health Care, Eric Topol argues that medicine is set to undergo its biggest shakeup in history, pushed by demanding consumers and the availability of game-changing technology. Topol — a cardiologist, director of the Scripps Translational Science Institute and co-founder of the West Wireless Health Institute in La Jolla, Calif. — was recently interviewed for Knowledge@Wharton by C. William Hanson, III, a professor of anesthesiology and critical care, and director, surgical intensive care, at the Hospital of the University of Pennsylvania. Hanson’s latest book is titled, Smart Medicine: How the Changing Role of Doctors Will Revolutionize Health Care, published in 2011.

Below is an edited transcript of the conversation.

William Hanson: I thought it might be worthwhile to quickly give you a sense of who I am and where I’m coming from [in this interview]. I’m an anesthesiologist and an intensivist, primarily a surgical intensivist, and serve as chief medical information officer at Penn. So I have some interests that will skew in that direction.

I love the title of your book. There are many people on both sides of this question. Some would say that the creative destruction of medicine is a pretty scary concept, and I think there would be plenty of us who would agree that something drastic needs to happen. You’re obviously in the latter category.

Eric Topol: I’m in the [group that feels] something drastic needs to happen. I think it can happen, it will happen and I’m hoping that we can help facilitate or catalyze that.

Hanson: You have been in a prominent role in terms of questioning traditional medical concepts. Maybe you could describe for the audience what your personal practice is and some of the issues in which you have engaged the traditional medical establishment in the past.

Topol: What I’ve done to try to change medicine in many different ways [includes] research on how to come up with better therapies. These were in large trials, as large as 40,000 patients with heart attacks, but also in [other] ways, such as starting a new medical school with a very innovative curriculum and challenging a drug safety issue which was really important for the public. So I’ve had different experiences over the years.

But what was changing for me was that four or five years ago, we recognized we had this new emerging capability of digitizing human beings, which we’ve never had before. Everybody is used to digitizing books, movies and newspapers, whatever. But when you digitize human beings by knowing the sequence of their DNA, all their physiologic metrics, like their vital signs, their anatomy [and so forth], this comes together as a unique kairos — this supreme opportune moment in medicine.

Hanson: That’s a nice lead in. I want to return to that digitization because it is something I’m dealing with in our IT systems, as I’m sure you are — what to do with the digitized information, how much of it to keep, how to analyze it. But I wanted to come back to your book title and to one of the gentlemen who endorsed the book, Clayton Christensen. He has written a couple of books as you know, including The Innovator’s Dilemma and The Innovator’s Prescription.

Topol: He has written three books on innovation and is renowned for his insights and leadership in [that] space. But there’s a little bit of a difference between us.

Hanson: Maybe you could elaborate on that.

Topol: Yes. I look to him as one of the real guiding lights of innovation. He’s not a physician. In the book, Innovator’s Prescription, he worked with a young physician, Jason Hwang, who is now out at Stanford.

Hanson: Yes, I have met him.

Topol: The difference, though, is that I am coming at it from almost three decades in the medical profession, and I’m not calling for an innovation. He calls it disruptive innovation. I’m looking at a much more radical thing. This is like taking what Clayton has popularized [and making it much bigger] … in terms of how transformative this can be, this whole ability to digitize human beings.

Hanson: In his work, he has talked about the digitization of the music industry, for example, and the film industry. Recognizing that you’re dealing at a much deeper level with the medical side of things, [it has to do with] how products enter the market at the low end and disrupt and take over higher-end products. For me and you at academic medical centers, where we think we’re providing state of the art care, I wonder to what extent we are likely to be made irrelevant by radical disruptions of the kind you’re talking about. What do you think about that?

Topol: I think that the medical community has been incredibly resistant to change. That’s across not just academic medical centers, but the whole continuum of medicine, [including] practicing physicians. But there is a consumer-driven health care revolution out there where each individual has access to their smart phone, all their vital signs and relevant data. There’s an ability to tap into their DNA sequence and all of their genomics. And of course that’s superimposed on this digital infrastructure that each person has now with a social network, with broadband Internet access and pervasive connectivity.

The Atlantic’s
 Q&A with Dr. Topol

Destroying Medicine to Rebuild It: Eric Topol on Patients Using Data

The emergency announcement on the transcontinental flight was terse and urgent: “Is there a doctor on board?” A passenger in distress was feeling intense pressure in his chest.

Eric Topol strode down the aisle to examine the passenger to see if he was having a heart attack, a diagnosis that normally would be tough at 35,000 feet. But Topol was armed with a prototype device that can take a person’s electrocardiogram (ECG) using a smartphone. The director of the Scripps Translational Science Institute near San Diego, he had just demonstrated how it worked during a lecture in Washington, D.C.

“It’s a case that fits over your iPhone with two built-in sensors connected to an app,” says Topol, showing me the device, made by Oklahoma City-based AliveCor. “You put your fingers on the sensors, or put them up to your chest, and it works like an ECG that you read in real-time on your phone.”

Dr. Topol’s guest blog for ForbesThe Power of Digitizing Human Beings and his Q&A with SalonThe Coming Medical Revolution

Read Wired’s Q&A with Dr. Topol: Why Doctors Need to Embrace Their Digital Future Now

Slate featured the book on their blog “Future Tense”

And here for an interview on Keen On (Tech Crunch TV): Why the Entrepreneurial Opportunities are Limitless http://www.pbgtoolkit.com/docs_pbg/1331561497Doc6.jpg

“Keen On” http://www.pbgtoolkit.com/docs_pbg/1331915366topol.jpg

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Treatment Options for Left Ventricular Failure  –  Temporary Circulatory Support: Intra-aortic balloon pump (IABP)Impella Recover LD/LP 5.0 and 2.5, Pump Catheters (Non-surgical) vs Bridge Therapy: Percutaneous Left Ventricular Assist Devices (pLVADs) and LVADs (Surgical) 

Author: Larry H Bernstein, MD, FCAP
Curator: Justin D Pearlman, MD, PhD, FACC


UPDATED on 12/2/2013 – HeartMate II – LVAD


Hospital Studies Link Heart Device to Clots

David Maxwell for The New York Times

Dr. Randall Starling, right, said that he could only speculate about the reason for the rapid rise in early blood clots.

Published: November 27, 2013

Doctors at the Cleveland Clinic began to suspect in 2012 that something might be wrong with a high-tech implant used to treat patients with advanced heart failure like former Vice President Dick Cheney.

Thoratec Corportation

The HeartMate II is a left ventricular assist device, which contains a pump that continuously pushes blood through the heart.

The number of patients developing potentially fatal blood clots soon after getting the implant seemed to be rising. Then early this year, researchers completed a check of hospital records and their concern turned to alarm.

The data showed that the incidence of blood clots among patients who got the device, called the HeartMate II, after March 2011 was nearly four times that of patients who had gotten the same device in previous years. Patients who developed pump-related clots died or needed emergency steps like heart transplants or device replacements to save them.

“When we got the data, we said, ‘Wow,’ ” said Dr. Randall C. Starling, a cardiologist at Cleveland Clinic.

On Wednesday, The New England Journal of Medicineposted a study on its website detailing the findings from the Cleveland Clinic and two other hospitals about the device. The HeartMate II belongs to a category of products known as a left ventricular assist device and it contains a pump that continuously pushes blood through the heart.

The abrupt increase in pump-related blood clots reported in the study is likely to raise questions about whether its manufacturer, Thoratec Corporation, modified the device, either intentionally or accidentally. By March, the Cleveland Clinic had informed both Thoratec and the Food and Drug Administration about the problems seen there, Dr. Starling said.

Officials at Thoratec declined to be interviewed. But in a statement, the company, which is based in Pleasanton, Calif., said that the HeartMate II had been intensively studied and used in more 16,000 patients worldwide with excellent results. It added that the six-month survival rate of patients who received the device had remained consistently high.

“Individual center experience with thrombosis varies significantly, and Thoratec actively partners with clinicians at all centers to minimize this risk,” the company said in a statement.

Thoratec and other cardiologists also pointed to a federally funded registry that shows a smaller rise in the rate of blood clots, or thrombosis, among patients getting a HeartMate II than the one reported Wednesday by the three hospitals. In the registry, which is known as Intermacs, the rate of pump-related blood clot associated with the HeartMate II rose to about 5 percent in devices implanted after May 2011 compared with about 2 percent in previous years.

The data reported on Wednesday in The New England Journal of Medicine found rates of clot formation two months after a device’s implant had risen to 8.4 percent after March 2011 from 2.2 percent in earlier years. Researchers also suggested in the study that the Intermacs registry might not capture all cases of pump-related blood clots, such as when patients gets emergency heart transplants after a clot forms.

Not only did the rate of blood clots increase, but the clots also occurred much sooner than in the past, according to the study. After March 2011, the median time before a clot was 2.7 months, compared with 18.6 months in previous years. In addition to the Cleveland Clinic, the report on Wednesday included data from Duke University and Washington University in St. Louis.

All mechanical heart implants are prone to producing blood clots that can form on a device’s surface. And experts say that the rate of blood clot formation can be affected by a variety of factors like changes in the use of blood-thinning drugs or the health of a patient.

In a telephone interview, Dr. Starling described the Thoratec officials as cooperative, adding that they have been looking into the problem since March to understand its cause. He said that he could only speculate about the reason for the rapid rise in early blood clots but believed it was probably device-related.

“My belief is that it is something as subtle as a change in software that affects pump flow or heat dissipation near a bearing,” said Dr. Starling, who is a consultant to Thoratec.

Asked about his comments, Thoratec responded that it had yet to determine the reason for even the smaller rise in blood clots seen in the federally funded database. “We have performed extensive analysis on HeartMate II and have not identified any change that would cause the increase observed in the Intermacs registry,” the company said.

In a statement, the F.D.A. said that it was reviewing the findings of the study. “The agency shares the authors concerns about the possibility of increased pump thrombosis,” the F.D.A. said in a statement.

The fortunes of Thoratec, which has been a favorite of Wall Street investors, may depend on its ability to find an answer to the apparent jump in pump-related blood clots. Over the last two years, the company’s stock has climbed from about $30 a share to over $43 a share. In trading Wednesday, Thoratec stock closed at $42.12 a share, up 61 cents. (The New England Journal of Medicine article was released after the stock market closed.)

The HeartMate II has been a lifesaver for many patients like Mr. Cheney in the final stages of heart failure, who got his device in 2010, sustaining them until they get a heart transplant or permanently assisting their heart. Dr. Starling said that he planned to keep using the HeartMate II in appropriate patients at the Cleveland Clinic because those facing death from heart failure had few options.

But the company has also been pushing to expand the device’s use beyond patients who face imminent death from heart failure. For example, the F.D.A. approved a clinical trial for patients with significant, but less severe, heart failure to receive a HeartMate II to compare their outcomes with patients who take drugs for the same condition. Researchers at the University of Michigan Medical Center who are leading the trial said on Wednesday that, based on the lower rates of blood clots seen in the Intermacs registry, they are planning to move forward with the trial.

Dr. Starling and researchers at the Cleveland Clinic tried this spring to get The New England Journal of Medicine to publish a report about the findings at that hospital, but the publication declined, saying the data might simply represent the experience of one facility. As a result, Dr. Starling contacted Duke University and Washington University for their data. When analyzed, it mirrored events at the Cleveland Clinic, he said.

The problems seen with the HeartMate II at the three hospitals were continuing as recently as this summer, when researchers paused the collection of data to prepare Wednesday’s study. The study also noted that a preliminary analysis of data provided by a fourth hospital, the University of Pennsylvania, showed the same pattern of blood clot formation, but that the data had been submitted too late for full analysis.



This article presents the following four Sections:

I.     Impella LD – ABIOMED, Inc.

II.   IABP VS. Percutaneous LVADS

III. Use of the Impella 2.5 Catheter in High-Risk Percutaneous Coronary Intervention

IV.  PROTECT II Study – Experts Discussion

This account is a vital piece of recognition of very rapid advances in cardiothoracic interventions to support cardiac function mechanically by pump in the situation of loss of contractile function and circulatory output sufficient to sustain life, as can occur with the development of cardiogenic shock.  This has been mentioned and its use has been documented in other portions of this series.   On the one hand, PCI has a long and steady history in the development of interventional cardiology. This necessitated the availability of thoracic-surgical operative support. The situation is changed, and is more properly, conditional.

I. Impella LD – ABIOMED, Inc.

This micro-axial blood pump can be inserted into the left ventricle via open chest procedures. The Impella LD device has a 9 Fr catheter-based platform and a 21 Fr micro-axial pump and is  inserted through the ascending aorta, across the aortic and mitral valves and into the left ventricle.  It requires minimal bedside support and a 9 Fr single-access point  requires no priming outside the body.


Impella Recover LD/LP 5.0

The Impella Recover miniaturized impeller pump located within a catheter. The Impella Recover LD/LP 5.0 Support System has been developed to address the need for ventricular support in patients who develop heart failure after heart surgery (called cardiogenic shock) and who have not responded to standard medical therapy. The system is designed to provide immediate support and restore hemodynamic stability for a period of up to 7 days. Used as a bridge to therapy, it allows time for developing a definitive treatment strategy.

The Pump

The Impella Recover LD 5.0 showing implantation via direct placement into the left ventricle.
 Insert B – location in LV
The Impella Recover system is a miniaturized impeller pump located within a catheter. The device can provide support for the left side of the heart using either the
  • Recover LD 5.0 (implanted via direct placement into the left ventricle) or the
  • Recover LP 5.0 LV (placed percutaneously through the groin and positioned in the left ventricle).
The microaxial pump of the Recover LP/LD 5.0 can pump up to 4.5 liters per minute at a speed of 33,000 rpm. The pump is located at the distal end of a 9 Fr catheter.

II.   IABP VS. Percutaneous LVADS

An intra-aortic balloon pump (IABP) remains the method of choice for mechanical assistance1 in patients experiencing LV failure because of its

  • proven hemodynamic capabilities,
  • prompt time to therapy, and
  • low complication rates.

Percutaneous left ventricular assist devices (pLVADs), such as described above, represent an emerging option for partial or total circulatory support2 and several studies have compared the and efficacy of these devices with intra-aortic balloon pump (IABP) (IABP.)

Despite some randomized controlled trials demonstrating better hemodynamic profiles for pLVADs compared with IABP, there is no difference in  30-day survival or trend toward a reduced 30-day mortality rate associated with pLVADs.  Patients treated with pLVADs tended to have a
  • higher incidence of leg ischemia and
  • device related bleeding.3
Further, no differences have been detected in the overall use of
  • positive inotropic drugs or
  • vasopressors in patients with pLVADs.4,5
However, pLVADs may increase their use for patients not responding to
  • PCI,
  • fluids,
  • inotropes, and
  • IABP
Therefore, the decision making process on how to treat requires an integrated stepwise approach. A pLVAD might be considered on the basis of
  • anticipated individual risk,
  • success rates, and for
  • postprocedural events.6

Potential Algorithm for Device Selection during High-Risk PCI

PADS_HRPCI cardiac assist device selection

Potential Algorithm for Device Selection during Cardiogenic Shock
Until an alternative modality, characterized by improved efficacy and safety features compared with IABP, is developed, IABP remains the cornerstone of temporary circulatory support.2

Device Comparison for Treatment of Cardiogenic Shocktraditional intra-aortic balloon therapy with Impella 2.5 percutaneous ventricular assist device

1. Percutaneous LVADs in AMI complicated by cardiogenic shock. H Thiele, et al. EHJ 2007;28:2057-2063
2. Cardiogenic shock current concepts and improving outcomes. H R Reynolds et al. Circulation 2008 ;117 :686-697
3. Percutaneous left ventricular assist devices vs. IABP counterpulsation for treatment of cardiogenic shock. J M Cheng, et al. EHJ doi:10.1093/eurheart/ehp292
4. A randomized clinical trial to evaluate the safety and efficacy of a pLVAD vs. IABP for treatment of cardiogenic shock caused by MI. M Seyfarth, et al. JACC 2008;52:1584-8
5. A randomized multicenter clinical study to evaluate the safety and efficacy of the tandem heart pLVAD vs. conventional therapy with IABP for treatment of cardiogenic shock.
6. Percutaneous LVADs in AMI complicated by cardiogenic shock. H Thiele, et al. EHJ 2007;28:2057-2063

III. Use of the Impella 2.5 Catheter in High-Risk Percutaneous Coronary Intervention

Brenda McCulloch, RN, MSN
Sutter Heart and Vascular Institute, Sutter Medical Center, Sacramento, California
Crit Care Nurse 2011; 31(1): e1-e16    http://dx.doi.org/10.4037/ccn2011293
The Impella 2.5 is a percutaneously placed partial circulatory assist device that is increasingly being used in high-risk coronary interventional procedures to provide hemodynamic support. The Impella 2.5 is able to unload the left ventricle rapidly and effectively and increase cardiac output more than an intra-aortic balloon catheter can. Potential complications include bleeding, limb ischemia, hemolysis, and infection. One community hospital’s approach to establishing a multidisciplinary program for use of the Impella 2.5 is described.
Patients who undergo high-risk percutaneous coronary intervention (PCI), such as procedures on friable saphenous vein grafts or the left main coronary artery, may have an intra-aortic balloon catheter placed if they require hemodynamic support during the procedure. Currently, the intra-aortic balloon pump (IABP) is the most commonly used device for circulatory support. A newer option that is now available for select patients is the Impella 2.5, a short-term partial circulatory support device or percutaneous ventricular assist device (VAD).
In this article, I discuss the Impella 2.5, review indications and contraindications for its use, delineate potential complications of the Impella 2.5, and discuss implications for nursing care for patients receiving extended support from an Impella 2.5. Additionally, I share our experiences as we developed our Impella program at our community hospital. Routine management of patients after PCI is not addressed.

IABP Therapy: Background

  • decreases after-load,
  • decreases myocardial oxygen consumption,
  • increases coronary artery perfusion, and
  • modestly enhances cardiac output.1,2
The IABP cannot provide total circulatory support. Patients must have some level of left ventricular function for an IABP to be effective.
Optimal hemodynamic effect from the IABP is dependent  on:
  • the balloon’s position in the aorta,
  • the blood displacement volume,
  • the balloon diameter in relation to aortic diameter,
  • the timing of balloon inflation in diastole and deflation in systole, and
  • the patient’s own blood pressure and vascular resistance.3,4

Impella 2.5 Catheter – ABIOMED, Inc.

  • reduces myocardial oxygen consumption,
  • improves mean arterial pressure, and
  • reduces pulmonary capillary wedge pressure.2

The Impella 2.5 has been used for

  • hemodynamic support during high-risk PCI and for
  • hemodynamic support of patients with
  1. myocardial infarction complicated by cardiogenic shock or ventricular septal defect,
  2. cardiomyopathy with acute decompensation,
  3. postcardiotomy shock,
  4. off-pump coronary artery bypass grafting surgery, or
  5. heart transplant rejection and
  6. as a bridge to the next decision.9
The Impella provides a greater increase in cardiac output than the other IABP provides. In one trial5 in which an IABP was compared with an Impella in cardiogenic shock patients, after 30 minutes of therapy, the cardiac index (calculated as cardiac output in liters per minute divided by body surface area in square meters) increased by 0.5 in the patients with the Impella compared with 0.1 in the patients with an IABP.
Unlike the IABP, the Impella does not require timing, nor is a trigger from an electrocardiographic rhythm or arterial pressure needed (Table 1). The device received 510(k) clearance from the Food and Drug Administration in June 2008 for providing up to 6 hours of partial circulatory support. In Europe, the Impella 2.5 is approved for use up to 5 days. Reports of longer duration of therapy in both the United States and Europe have been published.8,9
Table IABT vs Impella

Clinical Research and Registry Findings

Abiomed has sponsored several trials, including PROTECT I, PROTECT II, RECOVER I, RECOVER II, and ISAR-SHOCK.
The PROTECT I study was done to assess the safety and efficacy of device placement in patients undergoing high-risk PCI.10

Twenty patients who had

  • poor ventricular function (ejection fraction =35%) and had
  • PCI on an unprotected left main coronary artery or the
  • last remaining patent coronary artery or graft.

The device was successfully placed in all patients, and the duration of support ranged from 0.4 to 2.5 hours. Following this trial, the Impella 2.5 device received its 510(k) approval from the Food and Drug Administration.

The ISAR-SHOCK trial was done to evaluate the safety and efficacy of the Impella 2.5 versus the IAPB in patients with cardiogenic shock due to acute myocardial infarction.5 Patients were randomized to support from an IABP (n=13) or an Impella (n=12).

The trial’s primary end point of hemodynamic improvement was defined as improved cardiac index at 30 minutes after implantation.

  1. Improvements in cardiac index were greater with the Impella (P=.02).
  2. The diastolic pressure increased more with Impella (P=.002).
  3. There was a nonsignificant difference in the MAP (P=.09), as was the use of inotropic agents and vasopressors similar in both groups of patients.

Device Design: Impella 2.5 Catheter

The Impella 2.5 catheter contains a nonpulsatile microaxial continuous flow blood pump that pulls blood from the left ventricle to the ascending aorta, creating increased forward flow and increased cardiac output. An axial pump is one that is made up of impellar blades, or rotors, that spin around a central shaft; the spinning of these blades is what moves blood through the device.13

The Impella 2.5 catheter has 2 lumens. A tubing system called the Quick Set-Up has been developed for use in the catheterization laboratory. It is a single tubing system that bifurcates and connects to each port of the catheter. This arrangement allows rapid initial setup of the console so that support can be initiated quickly. When the Quick Set-Up is used, the 10% to 20% dextrose solution used to purge the motor is not heparinized. One lumen carries fluid to the impellar blades and continuously purges the motor to prevent the formation of thrombus. The proximal port of this lumen is yellow. The second lumen ends near the motor above the level of the aortic valve and is used to monitor aortic pressure.
The components required to run the device are assembled on a rolling cart and include the power source, the Braun Vista infusion pump, and the Impella console. The Impella console powers the microaxial blood pump and monitors the functioning of the device, including the purge pressure and several other parameters. The console can run on a fully charged battery for up to 1 hour.

Placement of the Device

The Impella 2.5 catheter is placed percutaneously through the common femoral artery and advanced retrograde to the left ventricle over a guidewire. Fluoroscopic guidance in the catheterization laboratory or operating room is required. After the device is properly positioned, it is activated and blood is rapidly withdrawn by the microaxial blood pump from the inlet valve in the left ventricle and moved to the aorta via the outlet area, which sits above the aortic valve in the aorta.
If the patient tolerates the PCI procedure and hemodynamic instability does not develop, the Impella 2.5 may be removed at the end of the case, or it can be withdrawn, leaving the arterial sheath in place, which can be removed when the patient’s activated clotting time or partial thromboplastin time has returned to near normal levels. For patients who become hemodynamically unstable or who have complications during the PCI (eg, no reflow, hypotension, or lethal arrhythmias), the device can remain in place for continued partial circulatory support, and the patient is transported to the critical care setting.

Potential Complications of Impella Therapy

The most commonly reported complications of Impella 2.5 placement and support include

  • limb ischemia,
  • vascular injury, and
  • bleeding requiring blood transfusion.6,9
Hemolysis is an inherent risk of the axial construction, and results in transfusions.5,10
Hemolysis can be mechanically induced when red blood cells are damaged as they pass through the microaxial pump. Other potential complications include
  • aortic valve damage,
  • displacement of the distal tip of the device into the aorta,
  • infection, and
  • sepsis.
  • Device failure, although not often reported, can occur.
Patients on Impella 2.5 support who may require
  • interrogation of a permanent pacemaker or
  • implantable cardioverter defibrillator
present an interesting situation. In order for the interrogator to connect with the permanent pacemaker or implantable cardioverter defibrillator, the Impella console must be turned off for a few seconds while the signal is established. As soon as the signal has been established, Impella support is immediately restarted.

Impella 2.5 Console Management

The recommended maximum performance level for continuous use is P8. At P8, the flow rate is 1.9 to 2.6 L/min and the motor is turning at 50000 revolutions per minute. When activated, the console is silent. No sound other than alarms is audible during Impella support, unlike the sound heard with an IABP. Ten different performance levels ranging from P0 to P9 are available. As the performance level increases, the flow rate and number of revolutions per minute increase. At maximum performance (P9), the pump rotates at 50000 revolutions per minute and delivers a flow rate of 2.1 to 2.6 L/min. P9 can be activated only for 5-minute intervals when the Impella 2.5 is in use.

IV.  PROTECT II Study – Experts Discussion

the use of the Impella support device and the intraortic balloon pump for high-risk percutaneous coronary intervention
DR. SMALLING: Well, the idea about the PROTECT trial is that it would show that using the Impella device to support high-risk angioplasty was not inferior to utilizing the balloon pump for the same patient subset. Ejection fraction’s were in the 30%–35% range. Supposedly last remaining vessel or left main disease or left-main plus three-vessel disease and low EF; so I think that was the screening for entry into the trial.
major adverse cardiac event endpoints
  1. Acute myocardial infarction,
  2. mortality,
  3. bleeding,
mortality was the same. Their endpoints really didn’t show that much difference. In subgroup analysis, they felt that they Impella may have had a little advantage over balloon pump.
DR. KERN: So do you think this study would tip the interventionalist to move in one direction or the other for high-risk angioplasty?
DR. SMALLING: That’s an interesting concept, you know? One has to get to: What is really a high-risk angioplasty. I think you and I are both old enough to remember that back in the mid-’80s, we determined that high-risk angioplasty was a patient with an ejection fraction of 25% or less, with a jeopardy score over 6. The EFs were a little higher. And, I guess, based on our prior experience with other support devices — like, for instance, CPS and then, later on, the Tandem Heart — there really was not an advantage of so-called more vigorous support systems. And so, the balloon pump served as well.
Those of us that have looked carefully at what it can really do, I think it may get one liter a minute at most, maybe more.1-6 But I think, for all intents and purposes, it doesn’t support at a very vigorous level. So I think personally, if I had someone I was really worried about, I would opt for something more substantial like, for instance, a Tandem Heart device.
DR. KERN: I think this is a really good summary of the study and the. Are there any final thoughts for those of us who want to read the PROTECT II study when it comes out?
DR. SMALLING: We have to consider a $20,000, $25,000 device. Is that really necessary to do something that we could often do without any support at all, or perhaps with a less costly device like a balloon pump.
DR. KERN: We’re going to talk for a few minutes about the PROTECT II study results that were presented here in their form. And Ron, I know you’ve been involved with following the work of the PROTECT II investigators. Were you a trial site for this study?
DR. WAKSMAN: No, actually, we were not, but we have a lot of interest in high-risk PCI and using devices to make this safe — mainly safe — and also effective. We were not investigators, but we did try to look, based on the inclusion/exclusion criteria, on our own accord with the balloon pump. If you recall, this study actually was comparing balloon time to the Impella device for patients who are high-risk PCI.
The composite endpoint was very complicated. They added like probably nine variables there, which is unusual for a study design. … They basically estimated that the event rate on the balloon pump would be higher than what we thought it should be. So we looked at our own data, and we found out that the actual — if you go by the inclusion/exclusion criteria and their endpoints — the overall event rate in the balloon pump would be much lower than they predicted and built in their sample size.
DR. KERN: And, so, the presentation of the PROTECT II trial, was it presented as a positive study or a negative study.
DR. WAKSMAN: Overall the study did not meet the endpoint. So the bottom line, you can call it the neutral study, which is a nice way to say it.
if you go and do all those analyses, you may find some areas that you can tease a P value, but I don’t think that this has any scientific value, and people should be very careful. We’re not playing now with numbers or with statistics, this is about patient care. You’re doing a study — the study, I think, has some flaws in the design to begin with — and we actually pointed that out when we were asked to participate in the study. But if the study did not meet the endpoint, then I think all those subanalyses, subgroups, you extract from here, you add to there, and you get a P value, that means nothing. So we have to be careful when we interpret this, other than as a neutral study that you basically cannot adopt any of the … it did not meet the hypothesis, that’s the bottom line.

A first-in-man study of the Reitan catheter pump for circulatory support in patients undergoing high-risk percutaneous coronary intervention.

Smith EJ, Reitan O, Keeble T, Dixon K, Rothman MT.
Department of Cardiology, London Chest Hospital, United Kingdom.
Catheter Cardiovasc Interv. 2009 Jun 1;73(7):859-65.

To investigate the safety of a novel percutaneous circulatory support device during high-risk percutaneous coronary intervention (PCI).


The Reitan catheter pump (RCP) consists of a catheter-mounted pump-head with a foldable propeller and surrounding cage. Positioned in the descending aorta the pump creates a pressure gradient, reducing afterload and enhancing organ perfusion.


Ten consecutive patients requiring circulatory support underwent PCI; mean age 71 +/- 9; LVEF 34% +/- 11%; jeopardy score 8 +/- 2.3. The RCP was inserted via the femoral artery. Hemostasis was achieved using Perclose sutures. PCI was performed via the radial artery. Outcomes included in-hospital death, MI, stroke, and vascular injury. Hemoglobin (Hb), free plasma Hb (fHb), platelets, and creatinine (cre) were measured pre PCI and post RCP removal.


The pump was inserted and operated successfully in 9/10 cases (median 79 min). Propeller rotation at 10,444 +/- 1,424 rpm maintained an aortic gradient of 9.8 +/- 2 mm Hg.  Although fHb increased,

  • there was no significant hemolysis (4.7 +/- 2.4 mg/dl pre vs. 11.9 +/- 10.5 post, P = 0.04, reference 20 mg/dl).
  • Platelets were unchanged (pre 257 +/- 74 x 10(9) vs. 245 +/- 63, P = NS).
  • Renal function improved (cre pre 110 +/- 27 micromol/l vs. 99 +/- 28, P = 0.004).

All PCI procedures were successful with no deaths or strokes, one MI, and no vascular complications following pump removal.

14F RCP first in man mechanical device post PCI LVEF 25% JS 10


The RCP can be used safely in high-risk PCI patients.

(c) 2009 Wiley-Liss, Inc.  PMID: 19455649

Todd J. Brinton, MD and Peter J. Fitzgerald, MD, PhD, Chapter 14: VENTRICULAR ASSIST TECHNOLOGIES


Other related articles published on this Open Access Online Scientific Journal include the following:

A coronary angiogram that shows the LMCA, LAD ...

A coronary angiogram that shows the LMCA, LAD and LCX. (Photo credit: Wikipedia)

English: Simulation of a wave pump human ventr...

English: Simulation of a wave pump human ventricular assist device (Photo credit: Wikipedia)

English: Figure A shows the structure and bloo...

English: Figure A shows the structure and blood flow in the interior of a normal heart. Figure B shows two common locations for a ventricular septal defect. The defect allows oxygen-rich blood from the left ventricle to mix with oxygen-poor blood in the right ventricle. (Photo credit: Wikipedia)


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Heart Transplant (HT) Indication for Heart Failure (HF): Procedure Outcomes and Research on HF, HT @ Two Nation’s Leading HF & HT Centers

Heart Transplant (HT) Indication for Heart Failure (HF) – Procedure Outcomes and Research on HF, HT @ Two Nation’s Leading HF & HT Centers:

Curator: Aviva Lev-Ari, PhD, RN

UPDATED on 10/15/2013


Practice Guideline | October 2013

2013 ACCF/AHA Guideline for the Management of Heart FailureA Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines

Clyde W. Yancy, MD, MSc, FACC, FAHA; Mariell Jessup, MD, FACC, FAHA; Biykem Bozkurt, MD, PhD, FACC, FAHA; Javed Butler, MBBS, FACC, FAHA; Donald E. Casey, MD, MPH, MBA, FACP, FAHA; Mark H. Drazner, MD, MSc, FACC, FAHA; Gregg C. Fonarow, MD, FACC, FAHA; Stephen A. Geraci, MD, FACC, FAHA, FCCP; Tamara Horwich, MD, FACC; James L. Januzzi, MD, FACC; Maryl R. Johnson, MD, FACC, FAHA; Edward K. Kasper, MD, FACC, FAHA; Wayne C. Levy, MD, FACC; Frederick A. Masoudi, MD, MSPH, FACC, FAHA; Patrick E. McBride, MD, MPH, FACC; John J.V. McMurray, MD, FACC; Judith E. Mitchell, MD, FACC, FAHA; Pamela N. Peterson, MD, MSPH, FACC, FAHA; Barbara Riegel, DNSc, RN, FAHA; Flora Sam, MD, FACC, FAHA; Lynne W. Stevenson, MD, FACC; W.H. Wilson Tang, MD, FACC; Emily J. Tsai, MD, FACC; Bruce L. Wilkoff, MD, FACC, FHRS


This article has THREE Parts:

Part One: National Organizations Addressing the Heart Transplant (HT) Indication for Heart Failure (HF)

Part Two: Procedure Outcomes of Heart Transplant (HT) Indication for Heart Failure (HF)

  • Center for Heart Failure @Cleveland Clinic, and
  • Transplant Center @Mayo Clinic

Part Three: Research  on Heart Transplant (HT) and Alternative Solutions Indicated for Heart Failure (HF)

  • Center for Heart Failure @Cleveland Clinic, and
  • Transplant Center @Mayo Clinic

Part One

National Organizations Addressing the 

Heart Transplant (HT) Indication for Heart Failure (HF)

The Clinical Deliberation of the Heart Failure Diagnosis and the Heart Transplant Treatment Decision

have taken central stage as it is related to

  • patient safety
  • prolongation of life
  • quality of life post procedure
  • procedure outcomes, and
  • cost of care for the patient diagnosed with Heart  Failure

VIEW VIDEO –  Sudden Cardiac Death in Heart Failure


We present below four National institutions with pubic mandate to promote all Healthcare aspects of Cardiovascular Diseases.

A.            2020 Vision of the Heart Failure Society of America (HFSA)

Special Communication: The Heart Failure Society of America in 2020: A Vision for the Future


From the 1Chair, ad hoc Committee for Strategic Development, Heart Failure Society of America; 2Member of Executive Council, Heart Failure Society of America and 3Member, ad hoc Committee for Strategic Development, Heart Failure Society of America.

They write:

The preceding 2 decades had been marked by unprecedented insights into the underlying pathophysiology of cardiac dysfunction that were paralleled by therapeutic advances that, for the first time, were shown to clearly improve outcomes in heart failure patients. At the same time, heart failure prevalence was rapidly increasing throughout the world because of the aging of the population, improved survival of patients with myocardial infarction and other cardiac conditions, and inadequate treatment of common risk factors such as hypertension.

More recently the Heart Failure Society successfully promoted establishment of Advanced Heart Failure and Transplant Cardiology as an American Board of Internal Medicine recognized secondary subspecialty of cardiology developed a board review course to help physicians prepare for the certification examination for the new subspecialty and created a national heart failure review course.

The Society has Advocacy goals, membership goals – to increase by 10% per year for 3 years from all disciplines of Heart Failure.

Education Goals:

The Heart Failure Society of America will be recognized for its innovative approaches to educating and content dissemination on heart failure targeting

  • healthcare professionals and patients
  • Grow and enhance the annual meeting through innovative approaches
  • Continue board review course
  • Increase web-based programs for patients and health care providers
  • Enhance the website as a portal for information dissemination for health care professionals and patients
  • Grow and enhance the relevance and value of the Journal of Cardiac Failure

Journal of Cardiac Failure Vol. 18 No. 2 2012

B.            American Heart Association Research on the National Cost of Care of Heart Failure

Conceptual analysis of projection done by the AHA regarding the increase in the Cost of Care for the the American Patient in Heart Failure were developed in the following two articles:

Economic Toll of Heart Failure in the US: Forecasting the Impact of Heart Failure in the United States -A Policy Statement From the American Heart Association (Aviva Lev-Ari)

Diagnosis of Cardiovascular Disease, Treatment and Prevention: Current & Predicted Cost of Care and the Promise of Individualized Medicine Using Clinical Decision Support Systems (Justin Pearlman, Larry H Bernstein and Aviva Lev-Ari)

C. National Heart, Lung, And Blood Institute  (NHLBI)’s Ten year Strategic Research Plan

Heart Transplantation: NHLBI’s Ten year Strategic Research Plan to Achieving Evidence-based Outcomes (Larry H Bernstein and Aviva Lev-Ari)

National Heart, Lung, And Blood Institute Working Group identified the most urgent knowledge gaps in Heart Transplantation Research. These gaps require to address the following 4 specific research directions:

  • enhanced phenotypic characterization of the pre-transplant population
  • donor-recipient optimization strategies
  • individualized immunosuppression therapy, and
  • investigations of immune and non-immune factors affecting late cardiac allograft outcomes.

D. Donor-Recipient Optimization Strategies – 33,640 Cases in the United Network for Organ Sharing database – Organ Donor’s Age is BEST predictor for survival after Heart Transplant

IF the donor age is in the 0- to 19-year-old group the median survival of 11.4 years follows the Heart Transplant.

The effect of ischemic time on survival after heart transplantation varies by donor age: An analysis of the United Network for Organ Sharing database

The Journal of Thoracic and Cardiovascular Surgery ● February 2007

J Thorac Cardiovasc Surg 2007;133:554-9

Mark J. Russo, MD, MS,a,b Jonathan M. Chen, MD,a Robert A. Sorabella, BA,a Timothy P. Martens, MD,a

Mauricio Garrido, MD,a Ryan R. Davies, MD,a Isaac George, MD,a Faisal H. Cheema, MD,a Ralph S. Mosca, MD,a Seema Mital, MD,c Deborah D. Ascheim, MD,b,d Michael Argenziano, MD,a Allan S. Stewart, MD,a Mehmet C. Oz, MD,a and Yoshifumi Naka, MD, PhDa


(1) To examine the interaction of donor age with ischemic time and their effect on survival and

(2) to define ranges of ischemic time associated with differences in survival.

Methods: The United Network for Organ Sharing provided de-identified patientlevel data. The study population included 33,640 recipients undergoing heart transplantation between October 1, 1987, and December 31, 2004. Recipients were divided by donor age into terciles: 0 to 19 years (n  10,814; 32.1%), 20 to 33 years (11,410, 33.9%), and 34 years or more (11,416, 33.9%). Kaplan-Meier survival functions and Cox regression were used for time-to-event analysis. Receiver operating characteristic curves and stratum-specific likelihood ratios were generated to compare 5-year survival at various thresholds for ischemic time.

Results: In univariate Cox proportional hazards regression, the effect of ischemic time on survival varied by donor age tercile: 0 to 19 years (P .141), 20 to 33 years (P .001), and 34 years or more (P .001). These relationships persisted in multivariable regression. Threshold analysis generated a single stratum (0.37-12.00 hours) in the 0- to 19-year-old group with a median survival of 11.4 years. However, in the 20- to 33-year-old-group, 3 strata were generated: 0.00 to 3.49 hours (limited), 3.50 to 6.24 hours (prolonged), and 6.25 hours or more (extended), with median survivals of 10.6, 9.9, and 7.3 years, respectively. Likewise, 3 strata were generated in the group aged 34 years or more: 0.00 to 3.49 (limited), 3.50 to 5.49 (prolonged), and 5.50 or more (extended), with median survivals of 9.1, 8.5, and 6.3 years, respectively.

Conclusions: The effect of ischemic time on survival after heart transplantation is dependent on donor age, with greater tolerance for prolonged ischemic times among grafts from younger donors. Both donor age and anticipated ischemic time must be considered when assessing a potential donor.

J Thorac Cardiovasc Surg 2007;133:554-9

Part Two

Procedures Outcomes of Heart Transplant (HT) Indication for Heart Failure (HF)

  • Center for Heart Failure @Cleveland Clinic, and

  • Transplant Center @Mayo Clinic


Center for Heart Failure @Cleveland Clinic: Institution Profile

Heart failure (sometimes called congestive heart failure or ventricular dysfunction) means your heart muscle is not functioning as well as it should. Either the left ventricle (lower chamber of the heart) is not contracting with enough force (systolic heart failure), or the ventricles are stiff and do not relax and fill properly (diastolic heart failure). The treatment of heart failure requires a specialized multidisciplinary approach to manage the overall patient care plan.

The George M and Linda H Kaufman Center for Heart Failure is one of the premier facilities in the United States for the care of people with heart failure.

  • The Kaufman Center Heart Failure Intensive Care was the recipient of the Beacon Award of Excellence for continuing improvements in providing the highest quality of care for patients. With over 6,000 ICUs in the Unites States, the Center joins a distinguished group of just 300 to receive this honor that recognizes the highest level of standards in patient safety and quality in acute and critical care.
  • In 2011, Cleveland Clinic received the American Heart Association’s Get With The Guidelines Heart Failure GOLD Plus Certification for improving the quality of care for heart failure patients. Gold Plus distinction recognizes hospitals for their success in using Get With The Guidelines treatment interventions. This quality improvement program provides tools that follow proven, evidence-based guidelines and procedures in caring for heart failure patients to prevent future hospitalizations.


The Kaufman Center for Heart Failure Team brings together clinicians that specialize in cardiomyopathies and ischemic heart failure. The team includes physicians and nurses from Cardiovascular Medicine, Cardiothoracic Surgery, Radiology, Infectious Disease, Immunology, Pathology, Pharmacy, Biothetics and Social Work with expertise in diagnostic testing, medical and lifestyle management, surgical procedures, and psychosocial support for patients with:

Please note Hypertrophic Cardiomyopathy is treated by our Hypertrophic Cardiomyopathy Center.

Patients at Cleveland Clinic Kaufman Center for Heart Failure have available to them the full array of diagnostic testing, treatments and specialized programs.

»Services Provided for Heart Failure Patients
»Specialized Programs for Heart Failure

Outcomes of Heart Failure and Heart Transplant @Cleveland Clinic

1,570 Number of heart transplants performed at Cleveland Clinic since inception of the Cardiac Transplant Program in 1984.

The survival rates among patients who have heart transplants at Cleveland Clinic exceeds the expected rates. Of the 150 transplant centers in the United States, Cleveland Clinic is one of only three that had better-than-expected one-year survival rates in 2011.

Ventricular Assist Device Volume 2007 – 2011

2007 – N = 23

2008 – N = 48

2009 – N = 76

2010 – N = 51

2011 – N = 56

Mechanical circulatory support (MCS) devices are used in patients with heart failure to preserve heart function until transplantation (bridge-to-transplant) or as a final treatment option (destination therapy). Cleveland Clinic has more than 20 years of experience with MCS devices for both types of therapy.

LVAD In-Hospital Mortality 2007 – 2011

Cleveland Clinic continues to make improvements to reduce mortality rates among patients who are placed on mechanical circulatory support. The mortality rate among patients who have a left ventricular assist device (LVAD) has been drastically reduced over the past five years.5% in 2011

VAD Mortality 2011

The mortality rate among Cleveland Clinic patients placed on ventricular assist devices (VADs) was much lower than expected in 2011. Observed 10%, Expected 17.5%

Heart Failure – National Hospital Quality Measures

This composite metric, based on four heart failure hospital quality process measures developed by the Centers for Medicare and Medicaid Services (CMS), shows the percentage of patients who received all the recommended care for which they were eligible. Cleveland Clinic has set a target of UHC’s 90th percentile.

Cleveland Clinic, 2010 (N = 1,194) 93.9%

Cleveland Clinic, 2011 (N = 1,163) 96.9%

UHC Top Decile, 2011 99.2%


University HealthSystem Consortium (UHC) Comparative Database, January through November 2011 discharges.

The Centers for Medicare and Medicaid Services (CMS) calculates two heart failure outcome measures: all-cause mortality and all-cause readmission rates, each based on Medicare claims and enrollment information. Cleveland Clinic’s performance appears below.

Heart Failure All-Cause 30-Day Mortality (N = 762)  July 2008 – June 2011

Cleveland Clinic 9.2%

National Average 11.6%

Heart Failure All-Cause 30-Day Readmission (N = 1,029)  July 2008 – June 2011

Cleveland Clinic 27.3%

National Average 24.7%



Cleveland Clinic’s heart failure risk-adjusted 30-day mortality rate is below the national average; the difference is statistically significant. Our heart failure risk-adjusted readmission rate is higher than the national average; that difference is also statistically significant. To further reduce this rate, a multidisciplinary team was tasked with improving transitions from hospital to home or post-acute care facility. Specific initiatives have been implemented in each of these focus areas: communication, education and follow-up.


Lung and Heart-Lung Transplant

In 2011, 51% of lung transplant patients were from outside the state of Ohio.

Cleveland Clinic surgeons transplanted 111 lungs in 2011. Our Lung and Heart-Lung Transplant

Program is the leader in Ohio and among the best programs in the country.

July 2010 – June 2011

160 Performed in 2009



Double Lung

Single Lung

53.5% Idiopathic

Primary Disease of Lung Transplant Recipients (N = 101)

Source: Scientific Registry of Transplant Recipients. March 2011. Ohio, Lung Centers, Cleveland Clinic. Table 7

Cleveland Clinic surgeons transplanted 111 lungs in 2011. Our Lung and Heart-Lung Transplant Program is the leader in Ohio and among the best programs in the country.

July 2010 – June 2011

53.5% Idiopathic Pulmonary Fibrosis (N = 54)

26.7% Emphysema/Chronic Obstructive Pulmonary Disease (N = 27)

9.9% Cystic Fibrosis (N = 10)

6.9% Idiopathic Pulmonary Arterial Hypertension (N = 7)

3.0% Other (N = 3)

Peripheral Vascular Diseases

Lower Extremity Interventional

Procedure Volume


Angioplasty 451

Atherectomy 74

Stenting 260

Thrombolysis 91

Lower Extremity Surgery Volume and Mortality (N = 303)

A total of 229 lower extremity bypass surgeries were performed in 2011. The 30-day

mortality rate was 0 percent. Cleveland Clinic’s vascular surgeons have expertise in this area

and strive to use autologous vein grafts.

2011 Volume

Bypass 229

Thrombectomy 74

2011 30-Day Mortality (%)

Bypass 0%

Noninvasive Vascular Lab Ultrasound Study Distribution (N = 36,775)


The Noninvasive Vascular Laboratory provides service seven days a week to diagnose arterial and

venous disorders throughout the vascular tree and for follow-up after revascularization procedures,

such as bypass grafts and stents. In 2011, 36,775 vascular lab studies were performed.

47% Venous Duplex (N = 17,284)

36% Arterial Duplex (N = 13,239)

17% Physiologic Testing (N = 6,252)


Transplant Center @Mayo Clinic: Heart Transplant Procedures Outcomes

Mayo Clinic History

Dr. W.W. Mayo with a horse and carriage.

Dr. W.W. Mayo

Portrait of the two Mayo brothers.

Drs. William (left) and Charles Mayo

Mayo Clinic developed gradually from the medical practice of a pioneer doctor, Dr. William Worrall Mayo, who settled in Rochester, Minn., in 1863. His dedication to medicine became a family tradition when his sons, Drs. William James Mayo and Charles Horace Mayo, joined his practice in 1883 and 1888, respectively.

From the beginning, innovation was their standard and they shared a pioneering zeal for medicine. As the demand for their services increased, they asked other doctors and basic science researchers to join them in the world’s first private integrated group practice.

Although the Mayo doctors were initially viewed as unconventional for practicing medicine through this teamwork approach, the benefits of a private group practice were undeniable.

As the success of their method of practice became evident, so did its acceptance. Patients discovered the advantages to a “pooled resource” of knowledge and skills among doctors. In fact, the group practice concept that the Mayo family originated has influenced the structure and function of medical practice throughout the world.

Along with its recognition as a model for integrated group practice, “the Mayos’ Clinic” developed a reputation for excellence in individual patient care. Doctors and students came from around the world to learn new techniques from the Mayo doctors, and patients came from around the world for diagnosis and treatment. What attracted them was not only technologically advanced medicine, but also the caring attitude of the doctors.

Through the years, Mayo Clinic has nurtured and developed its founders’ style of working together as a team. Shared responsibility and consensus still provide the framework for decision making at Mayo.

That teamwork in medicine is carried out today by more than 55,000 doctors, nurses, scientists, students and allied health staff at Mayo Clinic locations in the Midwest, Arizona and Florida.



2013 – Transplant Center @ Mayo Clinic:

Alternative Solutions to Treatment of Heart Failure

Mayo Clinic, with transplant services in Arizona, Florida and Minnesota, performs more transplants than any other medical center in the world. Mayo Clinic has pre-eminent adult and pediatric transplant programs, offering cardiac, liver, kidney, pancreas and bone marrow transplant services. Since performing the first clinical transplant in 1963, Mayo’s efforts to continually improve and expand organ transplantation have placed Mayo at the leading edge of clinical and basic transplant research worldwide. Research activities in the Transplant Center at Mayo Clinic have contributed significantly to the current successful outcomes of organ transplantation.

Transplant research articles

  1. Innovation in transplant surgical techniques
  2. Intestinal transplantation
  3. Laparoscopic donor nephrectomy
  4. Living-donor transplantation
  5. Mayo Clinic launches hand transplant program
  6. Multidisciplinary team approach
  7. Multiorgan transplants
  8. Paired kidney donation
  9. Pediatric services in transplant
  10. Regenerative medicine
  11. Toward a bioartificial liver: Buying time, boosting hope


VIEW VIDEO on  Mayo Clinic Heart Attack Study
People who survive a heart attack face the greatest risk of dying from sudden cardiac death (SCD) during the first month after leaving the hospital, according to a long-term community study by Mayo Clinic researchers of nearly 3,000 heart attack survivors.
Sudden cardiac death can happen when the hearts electrical system malfunctions; if treatment — cardiopulmonary resuscitation and defibrillation — does not happen fast, a person dies.
After that first month, the risk of sudden cardiac death drops significantly — but rises again if a person experiences signs of heart failure. The research results appear in the Nov. 5 edition of Journal of the American Medical Association.
Veronique Roger, M.D., a Mayo Clinic cardiologist provides an overview of the study and it’s findings.
For more information on heart attacks, click on the following link:http://www.mayoclinic.org/heart-attack/

VIEW VIDEO on Mayo Clinic Regenerative Medicine Consult Service – Stem Cell Transplantation post MI

In a proof-of-concept study, Mayo Clinic investigators have demonstrated that induced pluripotent stem (iPS) cells can be used to treat heart disease. iPS cells are stem cells converted from adult cells. In this study, the researchers reprogrammed ordinary fibroblasts, cells that contribute to scars such as those resulting from a heart attack, converting them into stem cells that fix heart damage caused by infarction. The findings appear in the current online issue of the journal Circulation.
Timothy Nelson, M.D., Ph.D., first author on the Mayo Clinic study, talks about the study and it’s findings.

Heart Transplant: Volumes and success measures Transplant Center@ Mayo Clinic

Mayo Clinic doctors’ experience and integrated team approach results in transplant outcomes that compare favorably with national averages. Teams work with transplant recipients before, during and after surgery to ensure the greatest likelihood of superior results.

Volumes and statistics are maintained separately for the three Mayo Clinic locations. Taken together or separately, transplant recipients at Mayo Clinic enjoy excellent results.



More than 100 heart transplants have been completed since the program began in 2005.


Surgeons at Mayo Clinic in Florida have performed more than 167 heart transplants and eight heart-lung transplants since the program began in 2001. Mayo surgeons have performed combined transplants, such as heart-kidney and heart-lung-liver transplants.


Mayo Clinic’s outcomes for heart transplantation compare favorably with national norms. Doctors at Mayo Clinic in Minnesota have transplanted more than 450 adult and pediatric patients, including both isolated heart transplants and combined transplants such as heart-liver, heart-kidney and others.

Success Measures

Heart Transplant Patient Survival — Adult

  1. Arizona

Mayo Clinic Hospital
(Phoenix, AZ)

  1. 1-month survival: 97.50%(n=40) • 2009-2011
  2. 1-year survival: 94.63%(n=40) • 2009-2011
  3. 3-year survival: 82.22%(n=45) • 2006-2008
  4. n = number of patients

National Average

  1. 1-month survival: 95.89%
  2. 1-year survival: 90.21%
  3. 3-year survival: 81.79%

Source: Scientific Registry of Transplant Recipients, July 2012

  1. Florida

Mayo Clinic Hospital**
(Jacksonville, FL)

  1. 1-month survival: 95.08%(n=61) • 2009-2011
  2. 1-year survival: 91.50%(n=61) • 2009-2011
  3. 3-year survival: 81.82%(n=44) • 2006-2008
  4. n = number of patients
  5. **Surgeries before April 11, 2008, were performed at St. Luke’s Hospital in Jacksonville, FL.

National Average

  1. 1-month survival: 95.89%
  2. 1-year survival: 90.21%
  3. 3-year survival: 81.79%

Source: Scientific Registry of Transplant Recipients, July 2012

  1. Minnesota

Saint Marys Hospital
(Mayo Clinic)

  1. 1-month survival: 95.83%(n=48) • 2009-2011
  2. 1-year survival: 95.83%(n=48) • 2009-2011
  3. 3-year survival: 82.61%(n=46) • 2006-2008
  4. n = number of patients

National Average

  1. 1-month survival: 95.89%
  2. 1-year survival: 90.21%
  3. 3-year survival: 81.79%

Source: Scientific Registry of Transplant Recipients, July 2012

Heart Transplant Patient Survival — Children

  1. Minnesota

Saint Marys Hospital
(Mayo Clinic)

  1. 1-month survival: 100.00%(n=5) • 2009-2011
  2. 1-year survival: 100.00%(n=5) • 2009-2011
  3. 3-year survival: 60.00%(n=5) • 2006-2008
  4. n = number of patients

National Average

  1. 1-month survival: 96.38%
  2. 1-year survival: 91.31%
  3. 3-year survival: 82.93%

Source: Scientific Registry of Transplant Recipients, July 2012

Heart Donor Organ (Graft) Survival — Adult

  1. Arizona

Mayo Clinic Hospital
(Phoenix, AZ)

  1. 1-month survival: 97.56%(n=41) • 2009-2011
  2. 1-year survival: 94.77%(n=41) • 2009-2011
  3. 3-year survival: 82.22%(n=45) • 2006-2008
  4. n = number of patients

National Average

  1. 1-month survival: 95.71%
  2. 1-year survival: 89.91%
  3. 3-year survival: 80.92%

Source: Scientific Registry of Transplant Recipients, July 2012

  1. Florida
  2. Mayo Clinic Hospital**
    (Jacksonville, FL)

    1. 1-month survival: 95.08%(n=61) • 2009-2011
    2. 1-year survival: 91.50%(n=61) • 2009-2011
    3. 3-year survival: 80.00%(n=45) • 2006-2008
    4. n = number of patients
    5. **Surgeries before April 11, 2008, were performed at St. Luke’s Hospital in Jacksonville, FL.

    National Average

    1. 1-month survival: 95.71%
    2. 1-year survival: 89.91%
    3. 3-year survival: 80.92%

Source: Scientific Registry of Transplant Recipients, July 2012

  1. Minnesota

Saint Marys Hospital
(Mayo Clinic)

  1. 1-month survival: 93.88%(n=49) • 2009-2011
  2. 1-year survival: 93.88%(n=49) • 2009-2011
  3. 3-year survival: 82.61%(n=46) • 2006-2008
  4. n = number of patients

National Average

  1. 1-month survival: 95.71%
  2. 1-year survival: 89.91%
  3. 3-year survival: 80.92%

Source: Scientific Registry of Transplant Recipients, July 2012

Heart-Lung Transplant Patient Survival — Adult

  1. Florida

Mayo Clinic Hospital**
(Jacksonville, FL)

  1. 1-month survival: 0.00%(n=0) • 2009-2011
  2. 1-year survival: 0.00%(n=0) • 2009-2011
  3. 3-year survival: 0.00%(n=1) • 2006-2008
  4. n = number of patients
  5. **Surgeries before April 11, 2008, were performed at St. Luke’s Hospital in Jacksonville, FL.

National Average

  1. 1-month survival: 89.04%
  2. 1-year survival: 80.12%
  3. 3-year survival: 56.36%

Source: Scientific Registry of Transplant Recipients, July 2012

  1. Minnesota

Saint Marys Hospital
(Mayo Clinic)

  1. 1-month survival: 100.00%(n=2) • 2009-2011
  2. 1-year survival: 100.00%(n=2) • 2009-2011
  3. 3-year survival: 100.00%(n=1) • 2006-2008
  4. n = number of patients

National Average

  1. 1-month survival: 89.04%
  2. 1-year survival: 80.12%
  3. 3-year survival: 56.36%

Source: Scientific Registry of Transplant Recipients, July 2012

Heart-Lung Donor Organ (Graft) Survival — Adult

  1. Florida

Mayo Clinic Hospital**
(Jacksonville, FL)

  1. 1-month survival: 0.00%(n=0) • 2009-2011
  2. 1-year survival: 0.00%(n=0) • 2009-2011
  3. 3-year survival: 0.00%(n=1) • 2006-2008
  4. n = number of patients
  5. **Surgeries before April 11, 2008, were performed at St. Luke’s Hospital in Jacksonville, FL.

National Average

  1. 1-month survival: 89.04%
  2. 1-year survival: 80.02%
  3. 3-year survival: 57.93%

Source: Scientific Registry of Transplant Recipients, July 2012

  1. Minnesota

Saint Marys Hospital
(Mayo Clinic)

  1. 1-month survival: 100.00%(n=2) • 2009-2011
  2. 1-year survival: 100.00%(n=2) • 2009-2011
  3. 3-year survival: 100.00%(n=1) • 2006-2008
  4. n = number of patients

National Average

  1. 1-month survival: 89.04%
  2. 1-year survival: 80.02%
  3. 3-year survival: 57.93%

Source: Scientific Registry of Transplant Recipients, July 2012


Part Three

Research  on Heart Transplant (HT) and Alternative Solutions Indicated for Heart Failure (HF)

  • Center for Heart Failure @Cleveland Clinic, and

  • Transplant Center @Mayo Clinic

The Editorial decision to focus on Research on Heart Transplant (HT) and Alternative Solutions Indicated for Heart Failure (HF) is covered in 

Chapter 5

Invasive Procedures by Surgery versus Catheterization

and had yielded one Sub-Chapter (5.8)  The Human Heart & Heart-Lung Transplant. This Sub-Chapter deals with

  • Heart Failure – Organ Transplant: The Human Heart & Heart-Lung Transplant,
  • Implantable Assist Devices and the Artificial Heart,

This Chapter 5 is in Volume Three in a forthcoming three volume Series of e-Books on Cardiovascular Diseases

Cardiovascular Diseases: Causes, Risks and Management

The Center for Heart Failure @Cleveland Clinic’s, and the Transplant Center @Mayo Clinic’s Institutions Profiles, Procedures Outcomes and Selection of their Research are  now in: 

Volume Three

Management of Cardiovascular Diseases

Justin D. Pearlman MD ME PhD MA FACC, Editor

Leaders in Pharmaceutical Business Intelligence, Los Angeles

Aviva Lev-Ari, PhD, RN

Editor-in-Chief BioMed E-Book Series

Leaders in Pharmaceutical Business Intelligence, Boston


5.8  The Human Heart & Heart-Lung Transplant, Implantable Assist Devices and the Artificial Heart

Aviva Lev-Ari, PhD, RN

5.8.3 Mechanical Circulatory Assist Devices as a Bridge to Heart Transplantation or as “Destination Therapy“: Options for Patients in Advanced Heart Failure

Larry H. Bernstein, MD, FCAP and Aviva Lev-Ari, PhD, RN

5.8.4 Heart Transplantation: NHLBI’s Ten year Strategic Research Plan to Achieving Evidence-based Outcomes

Larry H Bernstein, MD, FCAP and Aviva Lev-Ari, PhD, RN

5.8.5 Orthotropic Heart Transplant (OHT): Effects of Autonomic Innervation / Denervation on Atrial Fibrillation (AF) Genesis and Maintenance

Larry H. Bernstein, MD, FCAP and Aviva Lev-Ari, PhD, RN

5.8.6 After Cardiac Transplantation: Sirolimus acts asimmunosuppressant Attenuates Allograft Vasculopathy

Larry H Bernstein, MD, FCAP and Aviva Lev-Ari, PhD, RN

5.8.7 Prognostic Marker Importance of Troponin I in Acute Decompensated Heart Failure (ADHF)

Larry H Bernstein, MD, FCAP and Aviva Lev-Ari, PhD, RN

5.8.8 Alternative Models of Artificial Hearts PENDING 

Larry H. Bernstein, Justin D. Pearlman, and A. Lev-Ari

From other Sub-Chapters in Chapter 5:

5.6.1 The Cardio-Renal Syndrome (CRS) in Heart Failure (HF)

Larry H. Bernstein, MD, FCAP and Aviva Lev-Ari, PhD, RN

5.4.3 Heart Remodeling by Design – Implantable Synchronized Cardiac Assist Device:Abiomed’s Symphony | Comments

Aviva Lev-Ari, PhD, RN


Read Full Post »

On Devices and On Algorithms: Arrhythmia after Cardiac Surgery Prediction and ECG Prediction of Paroxysmal Atrial Fibrillation Onset

Author, and Content Consultant to e-SERIES A: Cardiovascular Diseases: Justin Pearlman, MD, PhD, FACC


Article Curator: Aviva Lev-Ari, PhD, RN

Cleveland Clinic research spurs a device that could predict arrhythmia after cardiac surgery

April 30, 2013 9:03 am by  |


Heart doctors at the Cleveland Clinic  hope to give doctors a way to tell which patients might develop arrhythmia after cardiac surgery.

Atrial fibrillation (AFIB) is one of the most common complications of heart surgeries, and also occurs as a complication of elevated alcohol use, high blood pressure, valve disease or thyroid disease. Atrial fibrillation consists of the round parts of the Valentine heart (the atria) shivering chaotically instead of beating rhythmically. Atrial fibrillation is a common arrhythmia, eventually affecting 20% of adults. There are 3 varieties: paroxysmal (intermittent), persistent (continual) and permanent (unremitting).  When AFIB lasts longer than 24-48 hours the risk of forming a blood clot in the atria rises, which in turn can cause a stroke or a heart attack. AFIB often results in fast heart rates which may cause low blood pressure and its possible consequences (organ injury, heart attack). Also, prolonged fast rates weaken the heart (reversible rate-related cardiomyopathy), which can persist for months after regaining target ranges for the heart rates (target for rate control is 60-80/minute instead of the fast rates of 100-180/min that are common with untreated AFIB).

A scoring system (CHADS2) can predict who may suffer from a stroke due to AFIB that lasts >24-48 hours, and in particular, who may benefit from longterm anticoagulation (blood thinners to interfere with clot formation). A pill-in-the-pocket can stop AFIB within hours.  Amiodarone, a highly toxic medication (10% long-term uses face side effects of serious damage to liver, lung, thyroid or eyes), is often prescribed “off-label” (without FDA endorsement) because it is 70% effective in preventing AFIB recurrence, and it has less anticontractility (weakening of the strength of heart beats) than most other rhythm medications. Then next most effective medication for suppression of AFIB long-term is sotalol, which reduces the strength of heart contraction (may not be tolerated by patients with severe heart failure) and it prolongs QT interval of repolarization after each heartbeat, a risk factor for a deadly rhythm called torsades de pointes. Interventional cures (“AFIB ablation”) have been developed to prevent recurrences.

Predicting AFIB may have several benefits: (1) potentially, earlier use of pill-in-the-pocket could prevent episodes rather that wait for them to occur, get noticed, and then treated, as only ~50% of AFIB episodes are noticed by the patient, according to electrographic monitor reports; (2) surrogate endpoint (prediction of onset) may offer useful guidance as to sufficiency of a suppressive therapy to enable lower dosing of toxic treatments; (3)  surrogate endpoint (prediction of onset) may offer useful guidance as to sufficient lowering of alohol intake, sufficient control of blood pressure, sufficient control of thyroid abnormalities, and other prevention opportunities; (4) surrogate endpoints may facilitate AFIB ablation.

Work done in the lab of Dr. C. Allen Bashour indicated that most patients who experience atrial fibrillation after heart surgery show clues beforehand in the form of subtle changes in their ECG readings that aren’t detected with the way they’re monitored now.

Rindex Medical is commercializing a tool that would enable physicians to predict which patients will experience AF so they can receive prophylactic treatment before it occurs.

“Right now they basically guess, or treat everyone prophylactically,” said co-founder Alex Arrow. “Some clinicians say they have an intuition about who will get it, but it’s mostly guesswork.”

Rindex’s A-50 AF Prediction System uses algorithms developed at the Clinic to analyze a patient’s ECG signals through 17 steps and produce a score, from 1 to 100, of how likely that patient is to experience AF. Arrow said the final product will be a touch-screen monitor that displays a score and tracks the score over a nine-hour period.

The Redwood City, California, company has been issued the first of its patents for the device and the exclusive license from Cleveland Clinic to develop the technology. Self-funded by Arrow and co-founders Denis Hickey and Lucas Fairfield, Rindex has a working prototype and is making progress on preparations for its 510(k) application. Arrow said the company shouldn’t need to raise a series A until it’s ready for a clinical trial.

Many other research groups have explored ways to predict AF in its various forms from natriuretic peptides to ECG changes, but no method has been established as reliably for this purpose.

Read more: http://medcitynews.com/2013/04/cleveland-clinic-research-spurs-a-device-that-could-predict-arrhythmias-after-cardiac-surgery/#ixzz2ScbxIyW0


Dec 13, 2012

ECG predicts atrial fibrillation onset

Atrial fibrillation (AF), the most common cardiac arrhythmia, is categorized by different forms. One sub-type is paroxysmal AF (PAF), which refers to episodes of arrhythmia that generally terminate spontaneously after no more than a few days. Although the underlying causes of PAF are still unknown, it’s clear that predicting the onset of PAF would be hugely beneficial, not least because it would enable the application of treatments to prevent the loss of sinus rhythm.

Many research groups are tackling the issue of predicting the onset of PAF. Now, however, researchers in Spain have developed a method that assesses the risk of PAF at least one hour before its onset. To date, the approach has not only successfully discriminated healthy individuals and PAF patients, but also distinguished patients far from and close to PAF onset (Physiol. Meas. 33 1959).

“The ability to assess the risk of arrhythmia at least one hour before its onset is clinically relevant,” Arturo Martinez from the University of Castilla-La Mancha told medicalphysicsweb. “Our method assesses the P-wave feature time course from single-lead long-term ECG recordings. Using a single ECG lead reduces the computational burden, paving the way for a real-time system in future.”

Analysing sinus rhythm

If the heart is beating normally, the sinus rhythm observed on an ECG will contain certain generic features, such as a P-wave that reflects the atrial depolarization and a large characteristic R peak flanked by two minima representing the depolarization of the heart’s right and left ventricles. If an irregular heart beat is suspected, an ECG will be used and typical findings include the absence of a P-wave.

“We hypothesized that different stages of AF could be identified when analysing long-term recordings extracted from patients prone to AF,” commented Martinez. “Our method differs to others in that we also use just one single lead to detect small differences in features from the P-wave time course.”

P for paroxysmal

Martinez and his collaborators, Raul Alcaraz and Jose Rieta, studied 24-hour Holter ECG recordings from 24 patients in whom PAF had been detected for the first time. For each patient, the longest sinus rhythm interval in the recording was selected, and the two hours preceding the onset of PAF were analysed. These readings were compared with those from 28 healthy individuals. In all cases, only the trace from the V1 ECG lead was considered.

A major challenge for the researchers was to extract the P-wave from the baseline noise. To overcome this, they used an automatic delineator algorithm based on a phasor transform that determines the precise time point relating to the onset, peak and offset of the P-wave. The authors described this algorithm in a previous research paper (Physiol. Meas. 31 1467).

“All of the recordings in our study were visually supervised by expert cardiologists who corrected the P-wave fiducial points when needed,” said Martinez. “Even in the presence of noise, which generated an incredible amount of P-wave distortion, our delineator provided location errors lower than 8 ms.”

In order to assess which time course features might be useful to predict the onset of PAF, the researchers analysed a number of variables. First, they examined factors representing the duration of the P-wave (Pdur), such as the distance between the P-wave onset and peak (Pini) and the distance between the P-wave peak and its offset (Pter). They then studied factors relating P- to R-waves, such as the distance between the two waves’ peaks (PRk) and, finally, beat-to-beat P-wave factors, such as the distance between two consecutive P-wave onset points (PPon).

“The most remarkable trends were provided by the features measuring P-wave duration,” report the authors in their paper. “Pduridentified appropriately 84.21% of all the analysed patients, obtaining a discriminant accuracy of 90.79% and 83.33% between healthy subjects and PAF patients far from PAF and close to PAF, respectively. The metrics related to the PR interval showed the most limited ability to identify patient groups.”

About the author

Jacqueline Hewett is a freelance science and technology journalist based in Bristol, UK.


Original Article

Physiol Meas. 2010 Nov;31(11):1467-85. doi: 10.1088/0967-3334/31/11/005. Epub 2010 Sep 24.

Application of the phasor transform for automatic delineation of single-lead ECG fiducial points.

Martínez AAlcaraz RRieta JJ.


Innovation in Bioengineering Research Group, University of Castilla La Mancha, Spain. arturo.martinez@uclm.es


This work introduces a new single-lead ECG delineator based on phasor transform. The method is characterized by its robustness, low computational cost and mathematical simplicity. It converts each instantaneous ECG sample into a phasor, and can precisely manage P and T waves, which are of notably lower amplitude than the QRS complex. The method has been validated making use of synthesized and real ECG sets, including the MIT-BIH arrhythmia, QT, European ST-T and TWA Challenge 2008 databases. Experiments with the synthesized recordings reported precise detection and delineation performances in a wide variety of ECGs, with signal-to-noise ratios of 10 dB and above. For real ECGs, the QRS detection was characterized by an average sensitivity of 99.81% and positive predictivity of 99.89%, for all the analyzed databases (more than one million beats). Regarding delineation, the maximum localization error between automatic and manual annotations was lower than 6 ms and its standard deviation was in agreement with the accepted tolerances for expert physicians in the onset and offset identification for QRS, P and T waves. Furthermore, after revising and reannotating some ECG recordings by expert cardiologists, the delineation error decreased notably, becoming lower than 3.5 ms, on average, and reducing by a half its standard deviation. This new proposed strategy outperforms the results provided by other well-known delineation algorithms and, moreover, presents a notably lower computational cost.


Original Database

MIT-BIH Polysomnographic Database

This database is described in

Ichimaru Y, Moody GB. Development of the polysomnographic database on CD-ROM. Psychiatry and Clinical Neurosciences 53:175-177 (April 1999).

Please cite this publication when referencing this material, and also include the standard citation for PhysioNet:

Goldberger AL, Amaral LAN, Glass L, Hausdorff JM, Ivanov PCh, Mark RG, Mietus JE, Moody GB, Peng C-K, Stanley HE. PhysioBank, PhysioToolkit, and PhysioNet: Components of a New Research Resource for Complex Physiologic Signals. Circulation 101(23):e215-e220 [Circulation Electronic Pages; http://circ.ahajournals.org/cgi/content/full/101/23/e215]; 2000 (June 13).

The MIT-BIH Polysomnographic Database is a collection of recordings of multiple physiologic signals during sleep. Subjects were monitored in Boston’s Beth Israel Hospital Sleep Laboratory for evaluation of chronic obstructive sleep apnea syndrome, and to test the effects of constant positive airway pressure (CPAP), a standard therapeutic intervention that usually prevents or substantially reduces airway obstruction in these subjects. The database contains over 80 hours’ worth of four-, six-, and seven-channel polysomnographic recordings, each with an ECG signal annotated beat-by-beat, and EEG and respiration signals annotated with respect to sleep stages and apnea. For further information, see Signals and Annotations.

The database consists of 18 records, each of which includes 4 files:

Sleep/apneaannotations Beatannotations Signals Header View waveforms *
slp01a.st slp01a.ecg slp01a.dat slp01a.hea
slp01b.st slp01b.ecg slp01b.dat slp01b.hea
slp02a.st slp02a.ecg slp02a.dat slp02a.hea
slp02b.st slp02b.ecg slp02b.dat slp02b.hea
slp03.st slp03.ecg slp03.dat slp03.hea
slp04.st slp04.ecg slp04.dat slp04.hea
slp14.st slp14.ecg slp14.dat slp14.hea
slp16.st slp16.ecg slp16.dat slp16.hea
slp32.st slp32.ecg slp32.dat slp32.hea
slp37.st slp37.ecg slp37.dat slp37.hea
slp41.st slp41.ecg slp41.dat slp41.hea
slp45.st slp45.ecg slp45.dat slp45.hea
slp48.st slp48.ecg slp48.dat slp48.hea
slp59.st slp59.ecg slp59.dat slp59.hea
slp60.st slp60.ecg slp60.dat slp60.hea
slp61.st slp61.ecg slp61.dat slp61.hea
slp66.st slp66.ecg slp66.dat slp66.hea
slp67x.st slp67x.ecg slp67x.dat slp67x.hea

(*) You may follow these links to view the signals and st annotations using either WAVE (under Linux, SunOS, or Solaris) or WVIEW (under MS-Windows). To do so successfully, you must have configured your browser to use wavescript (for WAVE) or wvscript (for WVIEW) as a helper application, as described in the WAVE User’s Guide(see the section titled WAVE and the Web) and in Setting up WVSCRIPT.

Andrew Walsh observed that the calibration originally provided for the BP signal of record slp37 is incorrect (since it yielded negative BPs). slp37.hea now contains an estimated BP calibration that yields more plausible BPs; these should not be regarded as accurate, however, since there is no independent calibration standard available for this recording.

Original Article
Proc Inst Mech Eng H. 2010;224(1):27-42.

Finding events of electrocardiogram and arterial blood pressure signals via discrete wavelet transform with modified scales.

Ghaffari AHomaeinezhad MRAkraminia MDavaeeha M.


Cardiovascular Research Group, Department of Mechanical Engineering, K. N. Toosi University of Technology, Tehran, Iran.


A robust electrocardiogram (ECG) wave detection-delineation algorithm that can be applied to all ECG leads is developed in this study on the basis of discrete wavelet transform (DWT). By applying a new simple approach to a selected scale obtained from DWT, this method is capable of detecting the QRS complex, P-wave, and T-wave as well as determining parameters such as start time, end time, and wave sign (upward or downward). In the proposed method, the selected scale is processed by a sliding rectangular window of length n and the curve length in each window is multiplied by the area under the absolute value of the curve. In the next step, an adaptive thresholding criterion is conducted on the resulted signal. The presented algorithm is applied to various databases including the MIT-BIH arrhythmia database, European ST-T database, QT database, CinC Challenge 2008 database as well as high-resolution Holter data gathered in the DAY Hospital. As a result, the average values of sensitivity and positive prediction Se = 99.84 per cent and P+ = 99.80 per cent were obtained for the detection of QRS complexes with an average maximum delineation error of 13.7, 11.3, and 14.0 ms for the P-wave, QRS complex, and T-wave respectively. The presented algorithm has considerable capability in cases of a low signal-to-noise ratio, high baseline wander, and in cases where QRS complexes and T-waves appear with abnormal morphologies. Especially, the high capability of the algorithm in the detection of the critical points of the ECG signal, i.e. the beginning and end of the T-wave and the end of the QRS complex was validated by the cardiologist and the maximum values of 16.4 and 15.9 ms were recognized as absolute offset error of localization respectively. Finally, in order to illustrate an alternative capability of the algorithm, it is applied to all 18 subjects of the MIT-BIH polysomnographic database and the end-systolic and end-diastolic points of the blood pressure waveform were extracted and values of sensitivity and positive prediction Se = 99.80 per cent and P+ = 99.86 per cent were obtained for the detection of end-systolic, end-diastolic pulses.


Original Article

A robust wavelet-based multi-lead electrocardiogram delineation algorithm

  • a Department of Mechanical Engineering, K.N. Toosi University of Technology, Tehran, Iran
  • b CardioVascular Research Group (CVRG), Iran
  • c Non-invasive Cardiac Electrophysiology Laboratory, DAY Hospital, Tehran, Iran


A robust multi-lead ECG wave detection-delineation algorithm is developed in this study on the basis of discrete wavelet transform (DWT). By applying a new simple approach to a selected scale obtained from DWT, this method is capable of detecting QRS complex, P-wave and T-wave as well as determining parameters such as start time, end time, and wave sign (upward or downward). First, a window with a specific length is slid sample to sample on the selected scale and the curve length in each window is multiplied by the area under the absolute value of the curve. In the next step, a variable thresholding criterion is designed for the resulted signal. The presented algorithm is applied to various databases including MIT-BIH arrhythmia database, European ST-T Database, QT Database, CinC Challenge 2008 Database as well as high resolution Holter data of DAY Hospital. As a result, the average values of sensitivity and positive predictivity Se = 99.84% and P+ = 99.80% were obtained for the detection of QRS complexes, with the average maximum delineation error of 13.7 ms, 11.3 ms and 14.0 ms for P-wave, QRS complex and T-wave, respectively. The presented algorithm has considerable capability in cases of low signal-to-noise ratio, high baseline wander, and abnormal morphologies. Especially, the high capability of the algorithm in the detection of the critical points of the ECG signal, i.e. the beginning and end of T-wave and the end of the QRS complex was validated by cardiologists in DAY hospital and the maximum values of 16.4 ms and 15.9 ms were achieved as absolute offset error of localization, respectively.


  • ACL, area-curve length;
  • ECG, electrocardiogram;
  • DWT, discrete wavelet transform;
  • QTDB, QT database;
  • MITDB, MIT-BIH arrhythmia database; 
  • TWADB, T-wave alternans database;
  • CSEDB, common standards for electrocardiography database;
  • EDB, European ST-T database;
  • P+, positive predictivity (%);
  • Se,sensitivity (%);
  • FIR, finite-duration impulse response;
  • LE, location error;
  • CHECK#0, procedure of evaluating obtained results using MIT annotation files;
  • CHECK#1, procedure of evaluating obtained results consulting with a control cardiologist;
  • CHECK#2, procedure of evaluating obtained results consulting with a control cardiologist and also at least with 3 residents


  • ECG delineation;
  • Discrete wavelet transform;
  • Variable threshold;
  • Validation

Figures and tables from this article:

Full-size image (14 K)
Fig. 1. FIR filter-bank implementation to generate discrete wavelet transform based on à trous algorithm.
Full-size image (12 K)
Fig. 2. Graphical representation of the logic of the proposed simple transformation for detecting onset and offset edges. In case I, both area and curve length are minimum, (ACLI < ACLII ≤ ACLIII).
Full-size image (58 K)
Fig. 3. The flow-chart of the proposed wavelet-aided electrocardiogram delineation algorithm (rectangle: operation, ellipse: result).
Full-size image (113 K)
Fig. 4. An excerpted segment from a total delineated ECG. Delineated (a) P-waves, (b) QRS complexes and (c) T-waves. (Circles: edges of event, triangles: peak of events, Partition A: lead I, Partition B: lead II).
Full-size image (76 K)
Fig. 5. Procedure of detecting and delineating of P and T-waves using ACL signal between two successive QRS complexes. (a) Simultaneously depiction of ACL, original ECG and the corresponding selected DWT scale, (b) QRS delineation, and (c) P and T-waves delineation.

Volume 31, Issue 10, December 2009, Pages 1219–1227


Other related articles published on this Open Access Online Scientific Journal include the following:

Sustained Cardiac Atrial Fibrillation: Management Strategies by Director of the Arrhythmia Service and Electrophysiology Lab at The Johns Hopkins Hospital   http://pharmaceuticalintelligence.com/2012/10/16/sustained-cardiac-atrial-fibrillation-management-strategies-by-director-of-the-arrhythmia-service-and-electrophysiology-lab-at-the-johns-hopkins-hospital/

Cardiac Arrhythmias: A Risk for Extreme Performance Athletes                                                                                                                                                       http://pharmaceuticalintelligence.com/2012/08/08/cardiac-arrhythmias-a-risk-for-extreme-performance-athletes/

Acute Chest Pain/ER Admission: Three Emerging Alternatives to Angiography and PCI    http://pharmaceuticalintelligence.com/2013/03/10/acute-chest-painer-admission-three-emerging-alternatives-to-angiography-and-pci/

Dilated Cardiomyopathy: Decisions on implantable cardioverter-defibrillators (ICDs) using left ventricular ejection fraction (LVEF) and Midwall Fibrosis: Decisions on Replacement using late gadolinium enhancement cardiovascular MR (LGE-CMR)

Ablation Devices Market to 2016 – Global Market Forecast and Trends Analysis by Technology, Devices & Applications

Read Full Post »

Reporter: Aviva Lev-Ari, PhD, RN

Cause for Increased Cardiovascular Risk: proatherosclerotic metabolite, trimethylamine-N-oxide (TMAO).

Intestinal Microbial Metabolism of Phosphatidylcholine and Cardiovascular Risk

W.H. Wilson Tang, M.D., Zeneng Wang, Ph.D., Bruce S. Levison, Ph.D., Robert A. Koeth, B.S., Earl B. Britt, M.D., Xiaoming Fu, M.S., Yuping Wu, Ph.D., and Stanley L. Hazen, M.D., Ph.D.

N Engl J Med 2013; 368:1575-1584April 25, 2013DOI: 10.1056/NEJMoa1109400


Recent studies in animals have shown a mechanistic link between intestinal microbial metabolism of the choline moiety in dietary phosphatidylcholine (lecithin) and coronary artery disease through the production of a proatherosclerotic metabolite, trimethylamine-N-oxide (TMAO). We investigated the relationship among intestinal microbiota-dependent metabolism of dietary phosphatidylcholine, TMAO levels, and adverse cardiovascular events in humans.


We quantified plasma and urinary levels of TMAO and plasma choline and betaine levels by means of liquid chromatography and online tandem mass spectrometry after a phosphatidylcholine challenge (ingestion of two hard-boiled eggs and deuterium [d9]-labeled phosphatidylcholine) in healthy participants before and after the suppression of intestinal microbiota with oral broad-spectrum antibiotics. We further examined the relationship between fasting plasma levels of TMAO and incident major adverse cardiovascular events (death, myocardial infarction, or stroke) during 3 years of follow-up in 4007 patients undergoing elective coronary angiography.


Time-dependent increases in levels of both TMAO and its d9 isotopologue, as well as other choline metabolites, were detected after the phosphatidylcholine challenge. Plasma levels of TMAO were markedly suppressed after the administration of antibiotics and then reappeared after withdrawal of antibiotics. Increased plasma levels of TMAO were associated with an increased risk of a major adverse cardiovascular event (hazard ratio for highest vs. lowest TMAO quartile, 2.54; 95% confidence interval, 1.96 to 3.28; P<0.001). An elevated TMAO level predicted an increased risk of major adverse cardiovascular events after adjustment for traditional risk factors (P<0.001), as well as in lower-risk subgroups.


The production of TMAO from dietary phosphatidylcholine is dependent on metabolism by the intestinal microbiota. Increased TMAO levels are associated with an increased risk of incident major adverse cardiovascular events. (Funded by the National Institutes of Health and others.)

Supported by grants from the National Institutes of Health and its Office of Dietary Supplements (R01HL103866 and 1P20HL113452). The clinical study GeneBank was supported by grants from the National Institutes of Health (P01HL098055, P01HL076491, R01HL103931, and R01DK080732) and a Cleveland Clinic/Case Western Reserve University Clinical and Translational Science Award (UL1TR000439). Dr. Hazen was supported by a gift from the Leonard Krieger Fund. Mass spectrometry instrumentation used was housed within the Cleveland Clinic Mass Spectrometry Facility with partial support through a Center of Innovation by AB SCIEX.

Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.

We thank Linda Kerchenski and Cindy Stevenson for their assistance in recruitment of study participants and Amber Gist and Naomi Bongorno for their assistance in the preparation of earlier versions of the figures and the manuscript.


From the Department of Cellular and Molecular Medicine, Lerner Research Institute, Cleveland Clinic, Cleveland.

Address reprint requests to Dr. Hazen at the Cleveland Clinic, 9500 Euclid Ave. NC-10, Cleveland, OH 44195, or at hazens@ccf.org.



Gut Microbiota, the Genome, and Diet in Atherogenesis

Joseph Loscalzo, M.D., Ph.D.

N Engl J Med 2013; 368:1647-1649April 25, 2013DOI: 10.1056/NEJMe1302154

This article has no abstract; the first 100 words appear below.

The Galtonian distinction between the influence of genetics and environment on phenotype is now widely recognized as an overly simplistic dichotomy. Genes and environmental factors interact in myriad ways to modulate and modify the biology of all living organisms, challenging the notion that these two principal determinants of phenotype can ever truly act independently of each other. Environmental exposures and experiences can have a direct influence on the expression of genes through epigenetic processes or on the function of gene products through post-translational modification. Likewise, genetic factors influence the consequences of environmental exposures or stresses on the organism.


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Early Surgery May Benefit Some With Heart Infection

Reporter: Aviva Lev-Ari, RN


Early Surgery May Benefit Some With Heart Infection, but doctors say findings only apply to a certain few

June 27, 2012 

By Denise Mann
HealthDay Reporter


WEDNESDAY, June 27 (HealthDay News) — People with an advanced form of a heart infection called endocarditis may do better if they undergo early surgery than if they are treated with antibiotics initially, a new study suggests.

Infective or bacterial endocarditis occurs when bacteria settles in the heart lining or heart valve. In advanced cases, the abnormal bacterial growth, often called vegetation, can be large enough to break off and travel elsewhere in the body, such as to the brain, where it may cause a stroke. Advanced infective endocarditis can also damage the heart valve.

People with existing heart disease or heart-valve problems are most likely to develop endocarditis.

In a new study published June 28 in the New England Journal of Medicine, researchers evaluated close to 80 people, average age 47, with advanced infective endocarditis.

Of these, 37 had early surgery within 48 hours of their diagnosis, and 39 received conventional therapy with antibiotics while they were monitored to see if the infection abated. Thirty people placed in the conventional treatment group eventually had surgery.

Early surgery reduced the risk of developing an embolism (or clot) and did not increase the risk of in-hospital death, the study showed.

After six months, the rate of adverse events, including death, repeat hospitalization for congestive heart failure or a recurrence of endocarditis, was 3 percent in the early-surgery group versus 28 percent in the conventionally treated patients.

“Early surgery can be the preferred option to further improve clinical outcomes of infective endocarditis, which is associated with considerable morbidity and mortality,” said study author Dr. Duk-Hyun Kang, a cardiologist at University of Ulsan College of Medicine in Seoul, South Korea.

“If a patient with infective endocarditis has large vegetations and severe valve disease, we would advise them to request early referral to medical centers with adequate experience and resources for early surgery,” Kang said.

Surgery for infective endocarditis aims to remove all infected tissue, repair the heart tissue and repair or replace the affected valve.

Others experts said only certain patients would warrant early surgery.

The new study “showed that patients with the combination of large vegetations and valve dysfunction, even if they are stable and not in heart failure, have a high risk of suffering serious embolic events or to progress to heart failure with need for emergency surgery and that early surgery prevented these complications,” said Dr. Gosta Pettersson, co-author of an accompanying journal editorial and vice chair of thoracic and cardiovascular surgery at the Cleveland Clinic in Ohio.

Surgery does have its share of risks, however. “Historically, surgery for infective endocarditis was high-risk surgery, and the risk of recurrent infection on the replacement valve was also high,” he said.

“Today, several publications have demonstrated that the added risk of operating on a patient with active infection has been more or less neutralized,” Pettersson added.

Surgeons have become adept at removing all infected tissue and foreign material and determining how best to reconstruct the heart, he explained. “Taking care of this patient is a team work with close collaboration between infectious disease specialists, cardiologists and cardiac surgeons,” he said. Importantly, he noted, “surgery is a complement to antibiotics not an alternative.”

Not everyone with infective endocarditis should have surgery, Pettersson said. For example, the stable patient with small vegetations, preserved valve function and growth of bacteria sensitive to antibiotics does not need surgery. Severely ill patients who are unlikely to survive an operation or those who have irreversible brain damage from embolism would not be surgical candidates either, he pointed out.

Dr. Stephen Green, chief of cardiology at North Shore University Hospital in Manhasset, N.Y., said that the new findings only apply to a select few. “Patients in the study had very large vegetation and severe valve pathology,” Green said. “These tend to be the worst of the worst.”

Most people with infective endocarditis are treated with antibiotics. “We reserve surgery for people whose infections don’t resolve, have fever or bacteria in the bloodstream or whose valves get destroyed,” Green noted.

“Many people with milder forms can be treated with antibiotics and monitored long term to see if they need surgery,” he added. This study suggests that “if you get a really bad clump of stuff on a valve, even if it’s antibiotic-sensitive, maybe we should go to surgery earlier.”

More information

Learn more about infective endocarditis at the American Heart Association.

Copyright © 2012 HealthDay. All rights reserved.

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Treatment of Refractory Hypertension via Percutaneous Renal Denervation 

Curator: Aviva Lev-Ari, PhD, RN

UPDATED  8/5/2013

VIEW VIDEO – Editorial the Heart.org

Renal denervation: Clinical lessons from around the world

Renal Denervation treatment represents a medical subfield, it has its roots in surgical sympathectomy techniques dating back to the 1930s. This radical approach to blood pressure control, which did not specifically target renal nerves, was ultimately abandoned due to associated perioperative complications. However, experience in renal transplantation, a procedure in which the renal nerves are selectively severed, suggests that the denervated kidney can maintain volume and electrolyte homeostasis.



Potential effects of renal denervation are on improved glucose control, sleep apnea, and treatment of heart failure syndromes and renal dysfunction – all consequences of sustained hypersympathetic activity.

Based on these observations, the specific targeting of renal nerves as a major operative in the pathophysiology of hypertension and other conditions associated with increased sympathetic activity (renal dysfunction and heart failure) appears to be an attractive therapeutic approach.


A new therapeutic paradigm of percutaneous renal artery denervation using the application of radiofrequency (RF) energy (Symplicity renal denervation system [Ardian, acquired by Medtronic, Inc., Minneapolis, MN]) has recently been demonstrated to be safe, effective, and durable in significantly reducing systolic blood pressure in patients with resistant hypertension.

This new technology represents the first time that physicians have been able to target renal nerves specifically via a catheter-based intervention. This endovascular approach opens the door to better understanding the relationship between sympathetic hyperactivity and hypertension.

Current therapeutic strategies center on lifestyle changes and pharmacologic interventions; however, the rates of blood pressure control and therapeutic efforts to reduce the rate of progression of hypertensive end-organ damage (resulting in myocardial infarction, stroke, and renal dysfunction) remain a neglected priority.


Renal denervation is used to treat uncontrolled hypertension, or high blood pressure, by the ablation of the nerves that line the renal arteries using a catheter. The Cleveland Clinic called renal denervation the No. 1 healthcare innovation of 2012. More than 12 million patients worldwide whose blood pressure remains uncontrolled despite taking three or more anti-hypertensive medications representing a global market opportunity for renal denervation that could ultimately grow to $30 billion. The Millennium Research Group estimates that the hypertension-treating devices could generate $4.4 billion per year, Bloomberg reported. That number could swell if the FDA indicates the systems for simple hypertension and not just the drug-resistant sort. As Bloomberg notes, a boom in hypertension devices would be a welcome development for the device industry, which has struggled over the past four years with recalls, litigation and regulatory woes, leading to a 7% decline in Standard & Poor’s Healthcare Equipment Index.

“At least 23 companies, mainly smaller, private companies are developing products,” Wang said, based on information she gathered at the American College of Cardiology Conference in Chicago in March.



According to the American Heart Association, a 5 mm Hg (millimeters of mercury) reduction in systolic blood pressure results in a 14 percent decrease in stroke, a 9 percent decrease in heart disease, and a 7 percent decrease in overall mortality. Renal denervation has shown in clinical studies to be safe, durable and effective in reducing systolic blood pressure by as much as 20 percent.

Numerous analysts suggest that there are more than 12 million patients worldwide whose blood pressure remains uncontrolled, despite taking three or more anti-hypertensive medications. This represents a global market opportunity for renal denervation approaching $30 billion.

Procedure Benefits

Hypertension, though often asymptomatic, is the number one risk factor for premature death worldwide.1 Renal Denervation (RDN) treatment aims to address this condition at its source to provide a substantial and durable reduction in blood pressure. After the procedure, people can often return to their normal activities quickly. The benefit is often achieved after several weeks to months.

Benefits and New Indications for Usage of Intravascular Stimulation/Ablation of Autonomics

1. Reduction in Heart Rate and Heart Rate Variability

Dr. Scherlag experiments noted changes in heart rate which have also been reported in SYMPLICITY HTN-1 and SYMPLICITY HTN-2 (8-9).  The SYMPLICITY HTN-2 study demonstrated profound bradycardia in 13% of patients that was treated with atropine.

The intra-procedure effect on heart rate during renal artery denervation documented in the  SYMPLICITY trials is also manifest long term by measuring heart rate variability (10). Indeed, cardiac effects would be expected with autonomic modulation.  Besides the two example above showing that cardiac sympathetic denervation effects heart rate, there are many more that are just beginning to be reported in the literature.

These articles shows the effects of renal denervation on heart rate.


A Cleveland Clinic review article states: “Additionally, the resting heart rate was lower and heart rate recovery after exercise improved after the procedure, particularly in patients without diabetes.”

2. Renal Sympathetic Denervation lowers Atrial Fibrillation

This article discusses the effect of renal sympathetic denervation on atrial fibrillation.


3. Regression of Left Ventricular Hypertrophy, Increase in Ejection Fraction (EF) and improved Diastolic Dysfunction

“Brandt reported regression of left ventricular hypertrophy and significantly improved cardiac functional parameters, including increase in ejection fraction and improved diastolic dysfunction, in a study of 46 patients who underwent renal denervation. This findings suggests a potential beneficial effect on cardiac remodeling.” (Brandt MC, Mahfoud F, Reda S, et al. Renal sympathetic denervation reduces left ventricular hypertrophy and improves cardiac function in patients with resistant hypertension. J Am Coll Cardiol 2012; 59:901–909)

4. Reduction in Ventricular Tachyarrhythmias (VT)

“Ukena reported reduction in ventricular tachyarrhythmias in two patients with congestive heart failure who had therapy-resistant electrical storm.” (Ukena C, Bauer A, Mahfoud F, et al. Renal sympathetic denervation for treatment of electrical storm: first-inman experience. Clin Res Cardiol 2012; 101:63–67)

5. Intravascular Stimulation of Autonomics Effects on Heart Failure

The most recent data from Europe shows the following effects on heart failure:


Dr. Scherlag, writes, [N]early ten examples of the effects of “CARDIAC SYMPATHETIC DENERVATION” and what are the effects on the kidney?

No change in GFR.  No change in creatinine.


Procedure Risks

Although major complications are uncommon, RDN treatment carries many of the same risks as an angioplasty procedure for the treatment of artery disease. The catheter insertion site could become infected, become bruised or bleed heavily. Other possible complications include heart attack, stroke, kidney damage or malfunction, heart rhythm disturbances, arterial damage, hypotension, sudden cardiac death, burns and pain. Imaging agents, pain medications and anti-spasm agents are commonly used during the procedure and carry known risks.

1. Mathers, C., et al. World Health Organization; 2009


Medical Debate on the Procedure – The candidates are hypertensive patients receiving blood-pressure-lowering medication that are truly “resistant.”

The Symplicity system (Medtronic) is the far-and-away front runner, having demonstrated average office-based BP drops of 32/12 mm Hg at six months in the SYMPLICITY HTN 2 trial, as reported by heartwire, with 84% of patients having had a >10-mm-Hg drop in systolic blood pressure from baseline.

Upwards of 20 other companies, according to Dr Ron Waksman (Washington Hospital, DC), are busy developing competing systems, some of which were featured in a EuroPCR session devoted to emerging technologies in May 2012 in Paris.

Leading this pack is St Jude’s EnligHTN system, which received CE Mark on the opening day of the meeting. Dr Stephen Worthley (Royal Adelaide Hospital, Australia) presented 30-day results in 47 resistant-hypertension patients treated with the multielectrode, RF-ablation-based system. Mean office BP changes at one month in EnligHTN 1 were -28 systolic and -10 diastolic (p<0.0001 from baseline), with 78% of patients having systolic BP drops of >10 mm Hg.


In terms of safety, no serious complications were seen in the renal artery or at the access site in the EnligHTN study; minor procedure-related events included four hematomas, three vasovagal responses to sheath removal, and two postprocedure transient bradycardias.

Other devices featured in the session included a second RF-energy system and two ultrasound systems, see below technology description by supplier.

The risk of cardiovascular death doubles with every 20 point increase in systolic blood pressure, so an average blood pressure reduction of 28 points is quite significant and demonstrates just how effective the technology is. Principal investigator Prof. Stephen Worthley said in prepared remarks. “From other clinical trials studying the impact of renal denervation we have learned that blood pressure continues to be reduced over time, so I would not be surprised to see this trend continue and see an even greater benefit for patients.” St. Jude’s study included 47 patients with high blood pressure that wasn’t managed with drug therapy. Participants had an average of 176/96 mmHg baseline blood pressure, despite taking multiple medications, before the denervation procedure and an average of 148/87 mmHg after. More than 40% had systolic rates below 140 mmHg.


Interventionalists who spoke with heartwire were unvaryingly excited about the potential of renal denervation, with some caveats.

“You need enthusiasm to develop new things, and in hypertension we haven’t seen an innovation in decades,” Dr Thomas Lüscher (University Hospital Zürich, Switzerland) told heartwire. “So just the possibility that you would be able to have a persistent treatment effect by a procedure that helps severe hypertension patients and maybe in the future even the option to cure hypertension is very exciting indeed. But I agree it’s a dream at this point. I think we need the SYMPLICITY HTN 3 trial, which hopefully will confirm what the other studies have shown.”

Now enrolling at as many as 90 US centers, SYMPLICITY HTN 3, Lüscher pointed out, has design characteristics addressing two concerns with the earlier trials, namely a sham procedure for the control group and ambulatory blood-pressure monitoring in all patients.

During the same emerging-technologies session, Lüscher explored the albeit-scant data supporting a role for renal denervation in other conditions: everything from metabolic syndrome and obstructive sleep apnea to heart failure, atrial fibrillation, and polycystic-ovary syndrome.

But his counterpoint, Dr Jean Renkin (UCL St Luc University Hospital, Brussels, Belgium), was skeptical, pointing to the myriad unanswered questions with the technology.

“Currently, reasonably solid data are available only for patients with hypertension resistant to pharmacotherapy, which cannot necessarily be extrapolated to other forms of hypertension or conditions referred to [by Dr Lüscher]. However, at this point in time, no clouds have appeared in the sky, so let us dream on.”

Dr Renkin had one staggering number for the audience to consider: of 5000 patients who have undergone renal denervation, only 250 were actually treated as part of clinical studies. While no device has US approval, five denervation systems already hold CE Mark in Europe and are being used with increasing frequency.

Treating the Truly Medication Treatment “Resistant”

For a comprehensive presentation of Triple Antihypertensive Combination Therapy Significantly Lowers Blood Pressure in Hard-to-Treat Patients with Hypertension and Diabetes, refer to


Another talking point is the proportion of patients who are truly “resistant.” The number agreed on by Lüscher, Waksman, and session comoderator Dr Robert Whitbourn (St Vincent’s Hospital, Fitzroy, Australia) was that just 3% of all hypertensive patients receiving blood-pressure-lowering medication are truly “resistant.” Numbers as high as 30% have been suggested in other reports, he noted.

“Interestingly, when we’ve been involved in various trials, every cardiologist says they have hundreds of these patients, but when we actually go to get them, no one actually has any,” Whitbourn quipped. “I think it should be a sobering thought—the numbers are actually quite small.”

Dr William Wijns (Cardiovascular Center Aalst, Belgium), also speaking with heartwire, agreed that the subset was “small” but argued it was “still big numbers, millions of people,” and “a massive unmet need.”

Waksman, insisting he was “excited” by what he called “robust reductions in blood pressure,” nevertheless urged eager interventionalists to work with hypertension experts and resist the urge “to jump on patients before we truly verify that they are resistant to medical treatment.”

In the vast majority of people even for whom renal denervation is appropriate, it “won’t be a cure,” Waksman said. “Most of these patients will have to continue on medical treatment—this is not replacing medical treatment, it is just getting [patients] more in control.”


The Global Supplier Ecosystem for Renal Denervation Systems

US Campbell, CA Kona Medical is attempting to address these limitations. The system delivers energy from outside the patient to the renal nerves. Ultimately, the procedure will be a “no puncture,” noninvasive technique, compatible with technologies that will allow for temperature and lesion mapping. A noninvasive procedure will allow titration of the therapy— that is, the application of patient-specific dose fractions while monitoring therapeutic effect in between fractions. The basis of the technology is focused ultrasound, not high intensity (HIFU) as one might see and expect in the treatment of tumors, but low-intensity focused ultrasound (LIFU). The biologic underpinnings of this treatment are described in past literature for treating nerves using ultrasound. Kona noninvasive system. The system is depicted in a custom chair; another version of the system is compatible with a standard fluoroscopy or MRI table. Both ultrasound (through elastography and the evolution of temperature mapping and MRI) allow further imaging and analysis of the treatment area. The dose distribution surrounding the artery is that of an annular ring around the wall of the artery. Kona has shown in animal studies that a heat/vibratory cloud at one plane along the artery is highly effective at long-term inhibition of renal nerves with no visible effect on any portion of the artery at any time point.

US, Ronkonkoma, NY & Germany – Paradise  by ReCor Medical 6-F compatible catheter with a cylindrical transducer that emits ultrasound energy circumferentially, allowing for a more efficient renal denervation procedure First-in-human (15 patients at 3 months) BP drop, mm Hg -32/-16 at 3 mo. The ultrasound transducer lies within a low-pressure balloon that allows for self-centering of the transducer and gentle contact with the artery wall for uniform circumferential denervation. This means that nerves below the surface of the artery wall are damaged in 360° with a single emission. The balloon also enables cooled fluid to circulate during the energy delivery process, thereby cooling the endothelial wall and protecting it from any excessive heating that could be caused by other energy sources or designs. Preliminary F-I-M clinical data for PARADISE were reported previously at the “TRenD 2012” transcatheter renal denervation scientific meeting by cardiologist Thomas A. Mabin, M.D., Vergelegen Medi-Clinic, South Africa. The updated PARADISE data show that systolic blood pressure was reduced by a statistically significant average of 36 mm Hg in 8 patients at 90-days follow-up. The scientific literature demonstrates that only a 5 mm Hg reduction in BP results in a 14% decrease in stroke, a 9% decrease in heart disease, and a 7% decrease in mortality.

US, San Leandro, CA The Mercator Bullfrog by Mercator MedSystems, Inc. is a catheter-guided system designed to inject therapeutic agents directly, nonsystemically, and safely through blood vessel walls into adventitial tissues and has received US Food and Drug Administration 510(k) clearance. The Bullfrog catheter is tipped with a balloon-sheathed microneedle and is guided and inflated in a manner similar to an angioplasty catheter but with far lower expansion pressures (2 atm vs 6–20 atm) in vessels of 3 to 6 mm in diameter. It is compatible with 0.014-inch guidewires and 6-F introducer sheaths. When the desired injection site is reached, the balloon is inflated with saline and radiopaque contrast, securing the system for injection and sliding the microneedle through the vessel wall. Nonclinical studies have shown that the Bullfrog catheter is able to deliver up to 5 mL per injection into the renal artery adventitia with no apparent safety concerns. Guanethidine Ismelin) is delivered to the renal artery adventitia to accomplish sympathetic denervation. Given locally, guanethidine is known to induce an autonomic denervation directly and through an immune-mediated pathway. Mercator’s preclinical experiments have shown that guanethidine, injected at appropriate concentrations into the adventitial space around renal arteries, selectively ablates the nerves in the adventitia around the renal artery after a single, 20-minute procedure

J Neurosci. 1983;3:714-724

US – Laguna Hills, CA – V2 Radiofrequency Baloon by Vessix Vascular, Inc. Bipolar RF balloon catheter REDUCE-HTN pilot (10 patients)

BP drop, mm Hg -30/-11 at 1 mo V 2 catheter, a patented noncompliant balloon catheter with RF electrodes and thermistors mounted on the exterior of the balloon, and the proprietary V 2 bipolar RF generator. Once inserted into the renal artery, a 30-second inflation/treatment per renal artery delivers simultaneous RF therapy with independent temperature control to all electrode pairs. V 2 catheter is available in balloon diameters ranging from 4 to 7 mm, with a balloon length of 25 mm. Larger-diameter balloons have eight electrode pairs, and smaller-diameter balloons have four to six electrode pairs made of solid gold, which are biocompatible and facilitate good electrode contact with the renal arterial wall. In addition, the electrodes are radiopaque, allowing the V 2 catheter to be easily visualized under fluoroscopy. Beginning in the first quarter of 2012, the V 2 renal denervation system will be utilized in the company’s first international, multicenter clinical study: REDUCEHTN.

Israel, Tel Aviv – Tivus by Cardiosonic  A6-F transducer-tipped catheter, ultrasound energy (Animal data only) The solution for renal denervation is a high-intensity, nonfocused ultrasonic (US) catheter system named TIVUS (Therapeutic IntraVascular UltraSound) (Figure 3). By applying ultrasonic energy, the TIVUS technology enables remote, localized, controlled, and repeatable thermal modulation of the renal vessel wall tissue, resulting in safe renal nerve ablation. The remote thermal effect is located in the adventitia and perivascular region, with no thermal damage to the endothelium and media, therefore, preventing the development of vessel injury processes. Swine kidney tissue NE concentrations at 30- and 90-day follow-up have demonstrated successful renal denervation as witnessed by a 50% or more decline in tissue NE. Localized tissue thermal modulation/ablation, without damage to the blood vessel wall.

US, MN – SYMPLICITY HTN 2 by Medtronic   average office-based BP drops of BP drop, mm Hg 32/12 mm Hg at six months in the SYMPLICITY HTN 2 trial, as reported by heartwire, with 84% of patients having had a >10-mm-Hg drop in systolic blood pressure from baseline. 14 points in 30 days and 27 points after 1 year. Available in Europe. Medtronic is the furthest ahead in its development process, predicting it will get Symplicity on the American market by 2015. catheter in the renal artery near each kidney to deliver radiofrequency energy to ablate the nerves. A single electrode in contrast to St. Jude’s mutli-electrode approach, is already on the road to FDA review with clinical trials approved last summer in the U.S. Symplicity system has been safely used in nearly 5,000 patients since commercialization

US, MN – EnligHTN 1 by  St Jude radiofrequency (RF) energy to create lesions (tiny scars) along the renal sympathetic nerves Mean office BP changes at one month in BP drop, mm Hg 28 systolic and -10 diastolic after 1 month (p<0.0001 from baseline), with 78% of patients having systolic BP drops of >10 mm Hg. St. Jude Medical’s (St. Paul, MN) announcement in late 2011 of the first patient to be enrolled in their first-in-man ARSENAL trial 15 at the University of Adelaide

Ireland, Dublin – OneShot™ by Covidien acquisition of Maya Medical, Saratoga, CA New Irrigated RF Balloon Catheter secure first human use for the device in the third quarter of this year, followed by a CE mark for the drug-resistant hypertension treatment in 2013. Presumably, a filing with the FDA would follow that. the OneShot renal denervation system, was born out of the company’s extensive expertise in radiofrequency (RF) ablation and percutaneous coronary interventions (PCI), drawing upon the benefits and best practice standards of each distinct yet complementary clinical discipline. The result is a unique product platform that could further accelerate the paradigm shift in the management of resistant hypertension. consistent with Maya’s balloon-based approach is the ability to deliver predictable apposition of the RF electrode to the vessel wall for more controlled targeted delivery of the RF energy. By offering a more reliable single-treatment approach coupled with enhanced ease of use and reduced procedure times, Maya Medical believes its OneShot renal denervation system has the potential to significantly expand clinical adoption


US, Natick, MA Boston Scientific lags behind in the race to cash in on hypertension-treating devices, incoming CEO Michael Mahoney said at a Monday conference that it has a plan for its RDN renal denervation system. As MassDevice reports, Mahoney said Boston Sci expects to secure first human use for the device in the third quarter of this year, followed by a CE mark for the drug-resistant hypertension treatment in 2013.

St Jude’s EnligHTN system

Said Frank Callaghan, president of the St. Jude Medical Cardiovascular Division “This launch is important because it represents a significant growth opportunity and exemplifies our commitment to advancing the practice of medicine. We’ve applied the decades of insight we’ve gained from developing successful ablation technologies that treat cardiac arrhythmias to establish an innovative solution for hypertension.” With the unique basket design, each placement of the ablation catheter allows a consistent and predictable pattern of four ablations in 90-second intervals. Compared to single electrode ablations, the multi-electrode EnligHTN system has the potential to improve consistency and procedural reliability, save time as well as result in workflow and cost efficiencies. Additionally, the minimal catheter repositioning may result in a reduction of contrast and fluoroscopic (x-ray) exposure. The technology includes a guiding catheter, ablation catheter and ablation generator. The generator uses a proprietary, temperature-controlled algorithm to deliver effective therapy.



St Jude’s EnligHTN system – view video



Unveiled a Novel Renal Denervation System OneShot™ at EuroPCR congress in Paris on 5/16/2012. “Live” Cases with New Irrigated RF Balloon Catheter for Treatment of Medication-resistant Hypertension and poor outcomes of pharmacological agents. The OneShot system is an irrigated, radiofrequency (RF) based balloon catheter used to ablate the renal sympathetic nerves located in the outer wall of the renal arteries. The OneShot technology received CE mark clearance in February 2012.

The OneShot system was featured in “live” cases at the Covidien-sponsored “Tools & Techniques (TNT) Interventions” presentation and panel session for hypertension and renal denervation at the EuroPCR congress. Professor Dirk Scheinert performed two cases at Park Hospital in Leipzig, Germany, that were transmitted live at the Palais des Congrès de Paris. In addition, John Ormiston, MD, Medical Director for Mercy Angiography and President of the Asia-Pacific Society of Interventional Cardiology in New Zealand, presented first-in-human results of cases performed with the OneShot system in New Zealand. The OneShot system and Covidien’s other endovascular solutions was on display at the EuroPCR meeting.

Additional faculty in the TNT session is a distinguished group of speakers including:

Professor Karl-Heinz Kuck, MD, F.A.C.C. – Director, Cardiology Department
Allgemeines Krankenhaus St. Georg – Hamburg, Germany

Dr. Stephen R. Ramee, FACC, FSCAI
Ochsner Medical Center – New Orleans, Louisiana

Dr. John Ormiston, MBChB, FRACP – Medical Director
Mercy Hospital Angiography Unit – Auckland, New Zealand

Professor Marc Sapoval, MD, PhD – Department Head
Cardiovascular/Interventional Radiology – Hospital Pompidou University – Paris, France

Dr. Renu Virmani – Medical Director
CVPath Institute – Gaithersburg, Maryland

Covidien discloses that it purchased Maya Medical for $60 million in cash on April 20. If Maya Medical meets certain regulatory and sales milestones, it will receive up to an additional $170 million. Covidien notes that Maya Medical’s OneShot system received the CE Mark in February.

MedCity News was the first to report Covidien’s interest in Maya Medical on 5/8/2012.

In a note to investors Monday, analyst Bob Hopkins of Bank of America said that renal denervation “has the potential to be one of the largest new markets in medtech over the next 2-4 years and for [Covidien] this looks like another small deal with big potential.”


Clinical Trial for RAPID is ongoing

 Rapid Renal Sympathetic Denervation for Resistant Hypertension (RAPID)

This study is currently recruiting participants.

Verified June 2012 by Maya Medical

First Received on January 25, 2012.   Last Updated on June 4, 2012   History of Changes

Sponsor: Covidien (Maya Medical)
Collaborator: Meditrial Europe LTD
Information provided by (Responsible Party): Maya Medical
ClinicalTrials.gov Identifier: NCT01520506


Maya Medical OneShot™ Ablation System use is to deliver low-level radio frequency (RF) energy through the wall of the renal artery to denervate the human kidney.

Condition Intervention Phase
Hypertension, Resistant to Conventional Therapy Device: Maya Medical OneShot Phase 2
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy StudyIntervention Model: Single Group AssignmentMasking: Open LabelPrimary Purpose: Treatment
Official Title: Rapid Renal Sympathetic Denervation for Resistant Hypertension Using the Maya Medical OneShot™ Ablation System


Covidien into direct competition with Medtronic, whose Symplicity renal denervation system is approved in Europe. Currently, the system is being tested in the U.S. St. Jude Medical, Medtronic’s in-state rival, is also developing a therapy and that is expected to have a limited European market launch before the end of the year. But it is not only the larger players that Covidien will have to play against in Europe. A whole host of companies is developing products there, including ReCor Medical.



Medical device giant Medtronic (NYSE: MDT), November 23, 2010 said it has agreed to pay $800 million upfront, plus commercial milestone payments through 2015, to acquire Mountain View, CA-based Ardian. Medtronic had previously built up an 11 percent ownership stake in Ardian, when it invested with its venture backers, which include Morgenthaler Ventures, Advanced Technology Ventures, Split Rock Partners, and Emergent Medical Partners. Ardian’s windfall comes about one week after it presented some eye-opening clinical trial results in The Lancet, and at the American Heart Association’s scientific meeting.


Clinical Trial for SYMPLICITY is ongoing.

Renal Denervation in Patients With Uncontrolled Hypertension (SYMPLICITY HTN-3)

This study is currently recruiting participants.

Verified June 2012 by Medtronic Vascular

First Received on August 15, 2011.   Last Updated on June 11, 2012   History of Changes

Sponsor: Medtronic Vascular
Information provided by (Responsible Party): Medtronic Vascular
ClinicalTrials.gov Identifier: NCT01418261


The Symplicity HTN-3 study is a, multi-center, prospective, single-blind, randomized, controlled study of the safety and effectiveness of renal denervation in subjects with uncontrolled hypertension. Bilateral renal denervation will be performed using the Symplicity Catheter – a percutaneous system that delivers radiofrequency (RF)energy through the luminal surface of the renal artery.

Condition Intervention Phase
Uncontrolled Hypertension Device: Renal denervation (Symplicity Catheter System) Phase 3
Study Type: Interventional
Study Design: Allocation: RandomizedEndpoint Classification: Safety/Efficacy StudyIntervention Model: Parallel AssignmentMasking: Single Blind (Subject)Primary Purpose: Treatment


 The Symplicity™ Renal Denervation System has two main components:

The elements are designed to work together as an integrated system to ensure consistent performance:

Symplicity™ Catheter – Low profile, endovascular energy delivery catheter

Symplicity™ Generator – Automated, portable RF generator

The Symplicity Renal Denervation System uses controlled, low-power radiofrequency (RF) energy to deactivate the renal nerves, thereby selectively reducing both the pathologic central sympathetic drive to the kidney and the renal contribution to central sympathetic hyperactivity. The outcome, we hope, will be a significant and sustained reduction in both blood pressure and the level of systemically damaging neurohormones. Since the endovascular procedure does not involve an implant, patients recover quickly and can soon return to their daily living. The device may usher in a new era in the treatment of hypertension, hopefully allowing a one-time procedure to offer patients a long-lasting benefit.

Medtronic Procedure – view video



The entire industry subsegment is awaiting the results of SYMPLICITY HTN-3. Forecasts of market share by supplier will be predicated on this Clinical Trial completion.

Shutting down overactive nerves around the kidneys as a strategy for fighting resistant hypertension is “one of the most exciting growth markets in medical devices,” Sean Salmon, vice president and general manager of Medtronic’s coronary and peripheral business, said in a statement.

I had a piece in these pages last week about what kind of difference the Ardian treatment was making. The most recent Ardian study showed the new treatment, in combination with standard drugs, was able to bring average blood pressure scores down from 178 over 97 to 146 over 85 after six months of follow-up, while those who just got standard treatments were essentially unchanged. The results were “a big achievement,” according to Murray Esler, the study’s principal investigator.



REFERENCES for Dr. Scherlag’s 1999 Patent and pioneering work on Intravascular Stimulation/Ablation of Autonomics

1. Schauerte P, Scherlag BJ, Scherlag MA, Goli S, Jackman WM, Lazzara R. Transvenous parasympathetic cardiac nerve stimulation: an approach for stable sinus rate control. J Electrophysiol. 1999 Nov;10(11):1517-24.

2. Schauerte P, Scherlag BJ, Scherlag MA, Goli S, Jackman WM, Lazzara R. Ventricular rate control during atrial fibrillation by cardiac parasympathetic nerve stimulation: a transvenous approach. J Am Coll Cardiol. 1999 Dec;34(7):2043-50.

3. Schauerte P, Scherlag BJ, Pitha J, Scherlag MA, Reynolds D, Lazzara R, Jackman WM. Catheter ablation of cardiac autonomic nerves for prevention of vagal atrial fibrillation. Circulation. 2000 Nov 28;102(22):2774-80.

4. Scherlag MA, Scherlag BJ, Yamanashi W, Schauerte P, Goli S, Jackman WM, Reynolds D, Lazzara R. Endovascular neural stimulation via a novel basket electrode catheter: comparison of electrode configurations. J Interv Card Electrophysiol. 2000 Apr;4(1):219-24.

5. Scherlag BJ, Yamanashi WS, Schauerte P, Scherlag M, Sun YX, Hou Y, Jackman WM, Lazzara R. Endovascular stimulation within the left pulmonary artery to induce slowing of heart rate and paroxysmal atrial fibrillation. Cardiovasc Res. 2002 May; 54(2):470-5.

6. Hasdemir C, Scherlag BJ, Yamanashi WS, Lazzara R, Jackman WM. Endovascular stimulation of autonomic neural elements in the superior vena cava using a flexible loop catheter. Jpn Heart J. 2003 May;44(3):417-27.

7. Webster W Jr, Scherlag BJ, Scherlag MA, Schauerte P. Method and apparatus for   transvascular treatment of tachycardia and fibrillation. US Patent 6,292,695. Filed June 17, 1999.

8. Krum H, Schlaich M, Whitbourn R, Sobotka PA, Sadowski J, Bartus K, Kapelak B, Walton A, Sievert H, Thambar S, Abraham WT, Esler M. Catheter-based renal sympathetic denervation for resistant hypertension: a multicentre safety and proof-of-principle cohort study. Lancet. 2009;373(9671):1275-1281.

9. Symplicity HTN-2 Investigators. Renal sympathetic denervation in patients with treatment-resistant hypertension (The Symplicity HTN-2 Trial): a randomised controlled trial. Lancet. 2010;376:1903-1909.

10. Frank Himmel MD, Joachim Weil MD, Michael Reppel MD, Kai Mortensen MD, Klaas Franzen, Leidinger Ansgar MD, Heribert Schunkert MD, Frank Bode MD.  Improved Heart Rate Dynamics in Patients Undergoing Percutaneous Renal Denervation. Letter to the Editor. JCH. 31 MAY 2012.1751-7176.

Sympathetic Hyperactivity & Hypertension

For more information on hypertension, please visit the medical professional hypertension portal at TheHeart.org .

Siddiqi L, Joles JA, Grassi G, Blankestijn PJ. Is kidney ischemia the central mechanism in parallel activation of the renin and sympathetic system? J Hypertens. 2009 Jul;27(7):1341-9.

Augustyniak RA, Tuncel M, Zhang W, Toto RD, Victor RG. Sympathetic overactivity as a cause of hypertension in chronic renal failure. J Hypertens. 2002;20(1):3-9.

DiBona GF. Sympathetic nervous system and the kidney in hypertension. Curr Opin Nephrol Hypertens. 2002;11(2):197-200.

Mancia G, Grassi G, Giannattasio C, Seravalle G. Sympathetic activation in the pathogenesis of hypertension and progression of organ damage. Hypertension. 1999;34(4 Pt 2):724-728.

References in Scientific Journals about Renal Denervation Treatment

Symplicity HTN-2 Investigators. Renal sympathetic denervation in patients with treatment-resistant hypertension (The Symplicity HTN-2 Trial): a randomised controlled trial. Lancet. 2010;376:1903-1909.

Symplicity HTN-1 Investigators. Catheter-Based Renal Sympathetic Denervation for Resistant Hypertension – Durability of Blood Pressure Reduction Out to 24 Months. Hypertension. Volume 57, Number 5, May 2011.

Rippy, M. et al. Catheter-Based Renal Sympathetic Denervation: Chronic Preclinical Evidence for Renal Artery Safety. Clin Res Cardiol. 2011 Dec; 100(12): Pages 1095-1101.

Mahfoud, F. et al. Effect of Renal Sympathetic Denervation on Glucose Metabolism in Patients With Resistant Hypertension. Circulation. Volume 123, No. 18, May 10, 2011. Pages 1940-1946.

Witkowski A., et al. Effects of Renal Sympathetic Denervation on Blood Pressure, Sleep Apnea Course, and Glycemic Control in Patients with Resistant Hypertension and Sleep Apnea. Hypertension. Volume 58, Number 4, October 2011. Pages 559-565.

Krum H, Schlaich M, Whitbourn R, Sobotka PA, Sadowski J, Bartus K, Kapelak B, Walton A, Sievert H, Thambar S, Abraham WT, Esler M. Catheter-based renal sympathetic denervation for resistant hypertension: a multicentre safety and proof-of-principle cohort study. Lancet. 2009;373(9671):1275-1281.

Schlaich MP, Sobotka PA, Krum H, Lambert E, Esler MD. Renal Sympathetic-Nerve Ablation for Uncontrolled Hypertension. N Engl J Med. 2009;361(9):932-934.

Schlaich MP, Sobotka PA, Krum H, Whitbourn R, Walton A, Esler MD. Renal Denervation as a Therapeutic Approach for Hypertension. Novel Implications for an Old Concept. Hypertension. 2009;54(6):1195-1201.

Esler M. The 2009 Carl Ludwig Lecture: pathophysiology of the human sympathetic nervous system in cardiovascular diseases: the transition from mechanisms to medical management. J Appl Physiol. 2010;108(2):227-237.

Dibona GF, Esler MD. Translational Medicine: the antihypertensive effect of renal denervation. Am J Physiol Regul Integr Comp Physiol. 2010;298(2):R245-253.

Katholi RE, Rocha-Singh KJ. The role of renal sympathetic nerves in hypertension: has percutaneous renal denervation refocused attention on their clinical significance? Prog Cardiovasc Dis. 2009;52(3):243-248.

Doumas M, Faselis C, Papademetriou V. Renal Sympathetic Denervation and Systemic Hypertension. Am J Cardiol. 2010;105(4):570-576.

Schlaich MP, Krum H, Sobotka PA. Renal sympathetic nerve ablation: the new frontier in the treatment of hypertension. Curr Hypertens Rep. 2010;12(1):39-46.

Katholi RE, Rocha-Singh KJ, Goswami NJ, Sobotka PA. Renal nerves in the maintenance of hypertension: A potential therapeutic target. Curr Hypertens Rep. 2010;12:196-204.

Esler MD, Lambert EA, Schlaich M, Navar LG. The Dominant Contributor to Systemic Hypertension: Chronic Activation of the Sympathetic Nervous System vs Activation of the Intrarenal Renin-Angiotensin System. J Appl Physiol. 2010.

Fisher JP, Fadel PJ. Therapeutic strategies for targeting excessive central sympathetic activation in human hypertension. Exp Physiol. 2010;95(5):572-580.

Malpas SC. Sympathetic nervous system overactivity and its role in the development of cardiovascular disease. Physiol Rev. 2010;90:513-557.

Lambert GW, Straznicky NE, Lambert EA, Dixon JB, Schlaich MP. Sympathetic nervous activation in obesity and the metabolic syndrome–causes, consequences and therapeutic implications. Pharmacol Ther. 2010;126:159-172.

Masuo K, Lambert GW, Esler MD, Rakugi H, Ogihara T, Schlaich MP. The role of sympathetic nervous activity in renal injury and end-stage renal disease. Hypertens Res. 2010;33:521-528.

Schlaich MP, Socratous F, Hennebry S, Eikelis N, Lambert EA, Straznicky N, Esler MD, Lambert GW. Sympathetic activation in chronic renal failure. J Am Soc Nephrol. 2009;20(5):933-939.

Bock JS, Gottlieb SS. Cardiorenal syndrome: New perspectives. Circulation. 2010;121:2592-2600.

Goldsmith SR, Sobotka PA, Bart BA. The sympathorenal axis in hypertension and heart failure. Journal of Cardiac Failure. 2010;16(5):369-373.

Grassi G. Assessment of sympathetic cardiovascular drive in human hypertension: achievements and perspectives. Hypertension. 2009;54(4):690-697.

Ritz E. New approaches to pathogenesis and management of hypertension. Clin J Am Soc Nephrol. 2009;4(12):1886-1891.

Ritz E, Rump LC. Control of sympathetic activity–new insights; new therapeutic targets? Nephrol Dial Transplant. 2010;25(4):1048-1050.

Joyner MJ, Charkoudian N, Wallin BG. Sympathetic nervous system and blood pressure in humans: Individualized patterns of regulation and their implications. Hypertension. 2010;56:10-16.

Mann JF. Whats new in hypertension 2009? Nephrol Dial Transplant. 2010;25(1):37-41.

Bravo EL, Rafey MA, Nally JV, Jr. Renal denervation for resistant hypertension. Am J Kidney Dis. 2009;54(5):795-797.

King A. Hypertension: RF ablation of renal nerves. Nature Reviews Nephrology. 2009;5:364.

Doumas M, Douma S. Interventional management of resistant hypertension. Lancet. 2009;373(9671):1228-1230.

Paulis L. Novel therapeutic targets for hypertension. Nat Rev Cardiol. 2010.

OBrien E. Renal sympathetic denervation for resistant hypertension. Lancet. 2009;373(9681):2109; author reply 2109-2110.

Titze S, Uder M, Schmieder R. Renal nerve ablation: innovative therapy for treatment of resistant hypertension. MMW Fortschr Med. 2009;151(42):52-53.

Katona PG. Biomedical engineering in heart-brain medicine: A review. Cleve Clin J Med. 2010;77 Suppl 3:S46-50.

Abstracts about Renal Denervation Treatment

Schlaich M, Krum H, Walton T, Whitbourn R, Sobotka P, Esler M. Two-year durability of blood pressure reduction with catheter-based renal sympathetic denervation. Journal of Hypertension. 2010;28:e446.

Esler M, Schlaich M, Sobotka P, Whitbourn R, Sadowski J, Bartus K, et al. Catheter-Based Renal Denervation Reduces Total Body and Renal Noradrenaline Spillover and Blood Pressure in Resistant Hypertension. Journal of Hypertension. 2009;27(suppl 4):s167.

Schlaich MP, Krum H, Whitbourn R, Walton T, Lambert GW, Sobotka PA, et al. Effects of Renal Sympathetic Denervation on Noradrenaline Spillover and Systemic Blood Pressure in Patients with Resistant Hypertension. Journal of Hypertension. 2009;27(suppl 4):s154.

Schlaich M, Krum H, Walton T, Lambert E, Lambert G, Sobotka P, et al. A Novel Catheter Based Approach to Denervate the Human Kidney Reduces Blood Pressure and Muscle Sympathetic Nerve Activity in a Patient with End Stage Renal Disease and Hypertension. Journal of Hypertension. 2009;27(suppl 4):s437.


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