Heart Failure

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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

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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:

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

Curator: Aviva Lev-Ari, PhD, RN

UPDATED on 10/15/2013

http://archive.is/5kQgj

JACC Volume 62, Issue 16, October 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

[+] Author Information

J Am Coll Cardiol. 2013;62(16):e147-e239. doi:10.1016/j.jacc.2013.05.019

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

http://theheart.medscape.org/viewarticle/803124

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

Journal of Cardiac Failure Vol. 18 No. 2 2012 written by BARRY H. GREENBERG, MD,1,3 INDER S. ANAND, MD, PhD,2 JOHN C. BURNETT JR, MD,2,3 JOHN CHIN, MD,2,3 KATHLEEN A. DRACUP, RN, DNSc,3 ARTHUR M. FELDMAN, MD, PhD,3 THOMAS FORCE, MD,2,3 GARY S. FRANCIS, MD,3 STEVEN R. HOUSER, PhD,2 SHARON A. HUNT, MD,2 MARVIN A. KONSTAM, MD,3 JOANN LINDENFELD, MD,2,3 DOUGLAS L. MANN, MD,2,3 MANDEEP R. MEHRA, MD,2,3 SARA C. PAUL, RN, DNP, FNP,2,3 MARIANN R. PIANO, RN, PhD,2 HEATHER J. ROSS, MD,2 HANI N. SABBAH, PhD,2 RANDALL C. STARLING, MD, MPH,2 JAMES E. UDELSON, MD,2 CLYDE W. YANCY, MD, MSc,3 MICHAEL R. ZILE, MD,2 AND BARRY M. MASSIE, MD2,3

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

Objectives:

(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.

http://my.clevelandclinic.org/heart/departments-centers/heart-failure.aspx

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
http://my.clevelandclinic.org/heart/departments-centers/heart-failure.aspx

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%

SOURCE

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%

SOURCE:

hospitalcompare.hhs.gov

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.

http://my.clevelandclinic.org/Documents/outcomes/2011/outcomes-hvi-2011.pdf

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

Liver-Lung

Heart-Lung

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

2011

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)

2011

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)

http://my.clevelandclinic.org/Documents/outcomes/2011/outcomes-hvi-2011.pdf

Transplant Center @Mayo Clinic: Heart Transplant Procedures Outcomes

Mayo Clinic History

Dr. W.W. Mayo

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.

http://www.mayoclinic.org/history/

http://www.mayoclinic.org/tradition-heritage-artifacts/2-1.html

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

VIEW VIDEO on LVAD

http://www.mayoclinic.org/transplant-center/transplant-surgery-techniques.html

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.

Volumes

Arizona

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

Florida

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.

Minnesota

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

Arizona

Mayo Clinic Hospital
(Phoenix, AZ)

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

National Average

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

Source: Scientific Registry of Transplant Recipients, July 2012

Florida

Mayo Clinic Hospital**
(Jacksonville, FL)

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

National Average

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

Source: Scientific Registry of Transplant Recipients, July 2012

Minnesota

Saint Marys Hospital
(Mayo Clinic)

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

National Average

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

Source: Scientific Registry of Transplant Recipients, July 2012

Heart Transplant Patient Survival — Children

Minnesota

Saint Marys Hospital
(Mayo Clinic)

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

National Average

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

Source: Scientific Registry of Transplant Recipients, July 2012

Heart Donor Organ (Graft) Survival — Adult

Arizona

Mayo Clinic Hospital
(Phoenix, AZ)

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

National Average

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

Source: Scientific Registry of Transplant Recipients, July 2012

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: 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

Minnesota

Saint Marys Hospital
(Mayo Clinic)

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

National Average

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

Source: Scientific Registry of Transplant Recipients, July 2012

Heart-Lung Transplant Patient Survival — Adult

Florida

Mayo Clinic Hospital**
(Jacksonville, FL)

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

National Average

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

Source: Scientific Registry of Transplant Recipients, July 2012

Minnesota

Saint Marys Hospital
(Mayo Clinic)

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

National Average

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

Source: Scientific Registry of Transplant Recipients, July 2012

Heart-Lung Donor Organ (Graft) Survival — Adult

Florida

Mayo Clinic Hospital**
(Jacksonville, FL)

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

National Average

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

Source: Scientific Registry of Transplant Recipients, July 2012

Minnesota

Saint Marys Hospital
(Mayo Clinic)

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

National Average

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

Source: Scientific Registry of Transplant Recipients, July 2012

http://www.mayoclinic.org/heart-transplant/heart-transplant-success.html

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

avivalev-ari@alum.berkeley.edu

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

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

Aviva Lev-Ari, PhD, RN

5.8.2. 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)

Larry H Bernstein, MD, FCAP and Justin D Pearlman, MD, PhD, FACC

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

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Heart Failure: New Research in Treatment Strategies Cardiology, Cambridge Research Center, London

Posted in Cardiac & Vascular Repair Tools Subsegment, Cardiac and Cardiovascular Surgical Procedures, Cell Biology, Signaling & Cell Circuits, Ecosystems & Industrial Concentration in the Medical Device Sector, Electrophysiology, Frontiers in Cardiology and Cardiovascular Disorders, Infectious Disease & New Antibiotic Targets, Mechanical Assist Devices: LVAD, RVAD, BiVAD, Artificial Heart, Medical Devices R&D Investment, Origins of Cardiovascular Disease, tagged ACC, American College of Cardiology, American Society of Echocardiography, Cardiology, European Society of Cardiology, Heart Failure, Internal Medicine on July 5, 2013| Leave a Comment »

Reporter: Aviva Lev-Ari, PhD, RN

Heart Failure and Dietary Sodium: Do we know as much as we think?

Samar Sheth,1 Alan B. Weder2 and Scott L. Hummel2,3; 1. Department of Internal Medicine, University of Michigan; 2. Division of Cardiovascular Medicine, Department of Medicine, University of Michigan Medical School; 3. Staff Cardiologist, Department of Veterans Affairs Medical Center, Ann Arbor, Michigan

Treatment Strategies Cardiology, Volume 3 Issue 1, 44-48

Depolarisation Reserve: A New Identification Concept of Responders to Biventricular Stimulation.

Philippe Chevalier and Alina Scridon; Centre de Référence des Troubles du Rythme Cardiaque Héréditaires, Hôpital Cardiologique Louis Pradel, Bron Cedex

Treatment Strategies Cardiology, Volume 3 Issue 2, 65-70

Selective Site Pacing During Cardiac Resynchronization Therapy

Leonidas Tzogias and Attila Roka, Hospital of St. Raphael, New Haven, Connecticut

Treatment Strategies Cardiology, Volume 4 Issue 1, 37-40

The Clinical Utility of BNP with Heart Failure in the European Physician Oce Setting

Treatment Strategies Cardiology, Volume 4 Issue 2, 49-52

The Treatment of Virus-associated Inammatory Cardiomyopathy

Uwe Kühl and Heinz-Peter Schultheiss, Department of Cardiology and Pulmonology, Charité – Universitätsmedizin Berlin, Campus Benjamin Franklin, Berlin

Treatment Strategies Cardiology, Volume 4 Issue 2, 63-68

TREATMENT STRATEGIES – CARDIOLOGY

Treatment Strategies – Cardiology is a print (on request) and online eBook publication that provides its readership with a collection of comprehensive and thought-provoking articles from the most respected key opinion leaders, leading doctors and authorities in the cardiology field. The series informs and educates clinicians on the latest therapeutic and technological advances. Published in line with the foremost cardiology congresses, the editorial content includes an unbiased, independent inbound supplement reviewing either the ESC or ACC congress. The review is dedicated to bringing readers the latest cardiology breaking news, exhibition highlights, awards and prizes and research developments from the key-note presentations at the congress.

Treatment Strategies – Cardiology (European and US edition) is available online as a free-to-view eBook providing its readers with an exciting interactive experience. Easily accessible, user friendly and free-to-print, the eBook can provide you with a wide range of dynamic features, including links to external websites, newsletters and email addresses to direct readers to your specialist products and services forming strong links with media partnerships. Importantly, an eBook can be sent out to clients worldwide in an organised and professional layout that allows a far-reaching distribution of your products. The eBook also offers you the opportunity to include, on any page, videos and podcasts of current events such as symposium proceedings that you may wish to highlight for the readership. The latest eBook also permits the advertiser to track statistical data for each page and publication; including the number of unique visits, click though pages, geographical location of the visitor and average time spent viewing.

Advisory Panel

Treatment Strategies – Cardiology is shaped by an advisory panel of world-renowned specialists from the leading associations and societies, including experts from:

American College of Cardiology (ACC)
American Society of Echocardiography (ASE)
European Association of Cardiothoracic Anaesthesiologists (EACTA)
European Association of Echocardiography (EAE)

European Society of Cardiology (ESC)

Nicholas Antony Boon, Consultant Cardiologist, Royal Infirmary of Edinburgh, Honorary Reader, University of Edinburgh and former President of the British Cardiovascular Society   (BCS)

Carl J. Pepine, Professor of Medicine, Division of Cardiovascular Medicine, University of Florida; Past-President, American College of Cardiology (ACC)

Bertram Pitt, University of Michigan Medical Center, William Beaumont Hospital, Ann Arbor, Michigan; President of the Michigan Chapter of American College of Cardiology, Chairman, Young Investigator’s Award Committee of the American College of Cardiology, Chairman of the Reveal Committee of the ACC

For our full Editorial Advisory Panel list please click here.

US Edition

Treatment Strategies – Cardiology Volume 5 Issue 1 will include an unbiased, independent inbound supplement reviewing the ACC Congress, taking place in San Francisco in March. The inbound supplement will present the readers with the latest news, exhibition highlights, awards and prizes and research developments from the key-note presentations from the ACC. The publication will be published in April 2013.

European Edition

Treatment Strategies – Cardiology Volume 5 Issue 2 will include an independently written review of the ESC congress taking place in Amsterdam in August. The review is dedicated to bringing readers the latest cardiology news, exhibition highlights, awards and prizes and research developments from the key-note presentations at the congress. Please click on the image (below) to view the media pack as an eBook. Volume 5 Issue 2 will be published in September 2013.

SOURCE

http://www.cambridgeresearchcentre.co.uk/all-publications/cardiology/

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

Posted in Cardiac and Cardiovascular Surgical Procedures, Cardiovascular Pharmacogenomics, Chemical Biology and its relations to Metabolic Disease, FDA Regulatory Affairs, Frontiers in Cardiology and Cardiovascular Disorders, Health Economics and Outcomes Research, International Global Work in Pharmaceutical, Pharmaceutical Industry Competitive Intelligence, Pharmaceutical R&D Investment, tagged Acute decompensated heart failure, Creatinine, CRS, Heart Failure, Kidney, Renal function, Ultrafiltration on June 30, 2013| 2 Comments »

The Cardiorenal Syndrome in Heart Failure: Cardiac? Renal? syndrome?

Writer and Curator: Larry H. Bernstein, MD, FCAP

and

Curator: Aviva Lev-Ari, PhD, RN

Triposkiadis F, Starling RC, Boudoulas H, Giamouzis G, Butler J.
Heart Fail Rev. 2012 May;17(3):355-66. http://dx.doi.org/10.1007/s10741-011-9291-x Review

There has been increasing interest on the so-called cardiorenal syndrome (CRS), defined as

a complex pathophysiological disorder of the heart and kidneys where by acute or chronic dysfunction in one organ may induce acute or chronic dysfunction in the other.

In this review, we contend that there is lack of evidence warranting the adoption of a specific clinical construct such as the CRS within the heart failure (HF) syndrome by demonstrating that:

(a) the approaches and tools regarding the definition of kidney involvement in HF are suboptimal;
(b) development of renal failure in HF is often confounded by age, hypertension, and diabetes;
(c) worsening of renal function (WRF) in HF may be largely independent of alterations in cardiac function;
(d) the bidirectional association between HF and renal failure is not unique and represents one of the several such associations encountered in HF; and
(e) inflammation is a common denominator for HF and associated noncardiac morbidities.

Based on these arguments, we believe that

dissecting one of the multiple bidirectional associations in HF and
constructing the so-called cardiorenal syndrome is not justified pathophysiologically.

Fully understanding of all morbid associations and not only the cardiorenal, that is of great significance for the clinician who is caring for the patient with HF.

Ultrafiltration in Heart Failure with Cardiorenal Syndrome

N Engl J Med 2013; 368:1157-1160 http://dx.doi.org/10.1056/NEJMc1300456

Bart et al. (Dec. 13 issue)1 report the results of the Cardiorenal Rescue Study in Acute Decompensated Heart Failure (CARRESS-HF). They state that ultrafiltration was inferior to a strategy of stepped pharmacologic therapy with respect to the

bivariate primary end point of the change in the serum creatinine level and body weight in patients with acute decompensated heart failure.

It is unclear at first sight why renal function should be different at 96 hours only when serum creatinine concentrations are used as a marker of renal function,

but not when the level of cystatin C or the glomerular filtration rate are used.

How can this discrepancy be explained?

According to the study Ultrafiltration in Decompensated Heart Failure with Cardiorenal Syndrome

Bart BA., Goldsmith SR., Lee KL, Givertz MM, et al.
N Engl J Med 2012; 367:2296-2304 http://dx.doi.org/10.1056/NEJMoa1210357

Ultrafiltration is an alternative strategy to diuretic therapy for the treatment of patients with acute decompensated heart failure.

Little is known about the efficacy and safety of ultrafiltration in patients with acute decompensated heart failure

complicated by persistent congestion and worsened renal function.

Ultrafiltration was inferior to pharmacologic therapy with respect to the bivariate end point of

the change in the serum creatinine level and body weight 96 hours after enrollment (P=0.003),
owing primarily to an increase in the creatinine level in the ultrafiltration group.

At 96 hours, the mean change in the creatinine level was −0.04±0.53 mg per deciliter (−3.5±46.9 μmol per liter) in the pharmacologic-therapy group,
as compared with +0.23±0.70 mg per deciliter (20.3±61.9 μmol per liter) in the ultrafiltration group (P=0.003).

A higher percentage of patients in the ultrafiltration group than in the pharmacologic-therapy group had a serious adverse event (72% vs. 57%, P=0.03).
In a randomized trial involving patients hospitalized for acute decompensated heart failure,

worsened renal function, and
persistent congestion,

the use of a stepped pharmacologic-therapy algorithm was superior to a strategy of ultrafiltration for

the preservation of renal function at 96 hours,
with a similar amount of weight loss with the two approaches.

Advanced heart failure (pharmaceuticalintelligence.com)
Aggressive Fluid and Sodium Restriction in Acute Decompensated Heart Failure. (zedie.wordpress.com)
First drug to improve heart failure mortality in over a decade – HealthCanal.com (pharmaceuticalintelligence.com)
Beta-Blocker Response (23andme.com)
Phrenic Nerve Stimulation in Patients with Cheyne-Stokes Respiration and Congestive Heart Failure (pharmaceuticalintelligence.com)
Heart-failure admissions and mortality highest in winter and on weekends – TheHeart.Org (pharmaceuticalintelligence.com)
Acute Dialysis Quality Initiative (ADQI) (scicombinator.com)
FDA grants Breakthrough Therapy designation to Novartis’ serelaxin (RLX030) for acute heart failure. (zedie.wordpress.com)

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

Posted in Biomarkers & Medical Diagnostics, Biomedical Measurement Science, Chemical Biology and its relations to Metabolic Disease, FDA Regulatory Affairs, Frontiers in Cardiology and Cardiovascular Disorders, Health Economics and Outcomes Research, tagged Acute decompensated heart failure, ADHF, Heart Failure, Ortho Clinical Diagnostics, Patient, Troponin, Troponin T, Weight loss on June 30, 2013| 1 Comment »

Troponin I in acute decompensated heart failure: insights from the ASCEND-HF study

Writer and Curator: Larry H Bernstein, MD, FCAP

and

Curator: Aviva Lev-Ari, PhD, RN

Felker GM, Hasselblad V, Tang WH, Hernandez AF, Armstrong PW, et al.
Eur J Heart Fail. 2012 Nov;14(11):1257-64. http://dx.doi.org/10.1093/eurjhf/hfs110 Epub 2012 Jul 4.

AIMS: We examined the prognostic importance of cardiac troponin I (cTnI) in a cohort of patients enrolled in the ASCEND-HF study of nesiritide in acute decompensated heart failure (ADHF). Circulating troponins are a prognostic marker in patients with ADHF. Contemporary assays with greater sensitivity require reassessment of the significance of troponin elevation in HF.

METHODS: Cardiac troponin I was measured in a core laboratory in 808 ADHF patients enrolled in the ASCEND-HF biomarkers substudy using a sensitive assay (VITROS Trop I ES, Ortho Clinical Diagnostics) with a lower limit of detection of 0.012 ng/mL and a 99th percentile upper reference limit (URL) of 0.034 ng/mL. Patients with clinical evidence of acute coronary syndrome or troponin >5× the URL were excluded. Multivariable modelling was used to assess the relationship between log(cTnI) and in-hospital and post-discharge outcomes.

RESULTS:

Baseline cTnI was undetectable in 22% and
elevated above the 99th percentile URL in 50% of subjects.

cTnI levels did not differ based on HF etiology. After multivariable adjustment, higher cTnI was associated with worsened in-hospital outcomes such as

length of stay (P = 0.01) and
worsening HF during the index hospitalization (P = 0.01), but
was not associated with worsened post-discharge outcomes at 30 or 180 days.

The relationship between cTnI and outcomes was generally linear and

there was no evidence of a threshold effect at any particular level of cTnI.

CONCLUSION:

cTnI is elevated above the 99th percentile URL in 50% of ADHF patients and
predicts in-hospital outcome, but
is not an independent predictor of long-term outcomes.

This reviewer finds the results quite interesting, and the study was done with care. The Ortho Diagnostics method of cTnI is high-sensitivity assay, so that the lowest measureable level at < 10% CV is manyfold lower than the 4th generation assay.

Prior to the hs-cTNI, the diagnostic cutoff for

AMI was 1.0 ng/ml vs
the cTnT at 0.1 ng/ml using a ROC curve.

AMI did occur below the ROC cutoff in both cases, but the reasons for elevations other than AMI were determined to be CRF, and this was more accurate (a small probability with the cTnT between 0.085 and 0.1 ng/ml.

However, the findings in this study did indeed exclude symptomatic ACS, or cTnI at the level not > 5x ULN. [0.17 ng/ml] with the hs-TnI. The hs-cTnI assay opened up the identification of non-ACS elevation related to cardiomyocyte damage unrelated to plaque rupture, but related to a persistent coronary ischemia, possibly related to cardiomegaly and/or vascular rigidity.

Test Limitations

Troponins are not normally present in serum, so any amount present in serum (measured at the 99th percentile of the upper limit of normal at a 10% imprecision) indicates structural damage to the heart, although not necessarily AMI.

Both troponin I (TnI) and troponin T (TnT) are affected by renal insufficiency, but TnT is to a greater extent
100% of TnT is excreted in urine, but 70% of TnI is degraded by vascular endothelium; this means that minor elevations of troponins have to be considered in the context of comorbidities, especially renal impairment, and risk factors
Among heart failure patients, the objective parameter of NT-proBNP seems more useful to delineate the “cardiorenal syndrome” than the previous criteria of a clinical diagnosis of heart failure

However, the NT-proBNP is best interpreted by using the log(NT-proBNP)/eGFR with an adjustment.

These investigators used the log(cTnI), which I would not have thought of in this case, but it is important to do because the distribution of the peptide levels in the study population would be nonparametric. The median values at the time points are not given. Actually, there are presumably, not definitely, two populations – if you were to infer short- and long-term outcomes measured as 30-days, and 180-days. That a baseline cTNI was undetectable in 22% of patients is actually not so different than would be found in a random selection from patients presenting to the emergency department. It should not be a surprise that the test as a single predictor, did not meet the requirement for long-term prediction of outcome, despite agreement with the in-hospital outcome. This is consistent with the absence of ACS.

[1] Troponins (Cardiac-specific Troponin I and Troponin T). LH Bernstein. http://PathologyOutlines.com/Chemistry
[2] Effect of renal function loss on NT-proBNP level variations. LH Bernstein, MY Zions, SA Haq, S Zarich, J Rucinski, B Seamonds, et al. Clin Biochem 2009; 42(10-11):1091-1098. ICID: 937529 http://dx.doi.org/10.1016/j.clinbiochem.2009.02.027.
[3] Enhancing the diagnostic performance of troponins in the acute care setting. SA Haq, M Tavakol, S Silber, L Bernstein, J Kneifati-Hayek, M Schleffer, et al. J Emerg Med 2008; x:x ICID: 937619
http://www.nymethodistemergencymedicine.com/program/research.html
[4] Comparison of test characteristics of cardiac troponin T in patients with normal renal function and chronic renal failure evaluated in the emergency department. S Silber, L Melniker, E Haines, LH Bernstein.
Academic Emergency Medicine 2006; 13(5):S1186-187.   ICID: 939943   http://www.nymethodistemergencymedicine.com/program/research.html
[5} The ACC/ESC Recommendation for 99th Percentile of the Reference Normal Troponin I Overestimates the Risk of an Acute Myocardial Infarction: a novel enhancement in the diagnostic performance of troponins. “6th Scientific Forum on Quality of Care and Outcomes Research in Cardiovascular Disease and Stroke.” S Haq, M Tavakol, LH Bernstein, J Kneifati-Hayek, M Schlefer, S Silber, T Sacchi, J Pima. Circulation 2005; 111(20):e313-313. ICID: 939931
http://pt.wkhealth.com/pt/re/circ/toc.00003017-200505240-00000.htm
[6] Minor elevations in troponin T values enhance risk assessment in emergency department patients with suspected myocardial ischemia: analysis of novel troponin T cut-off values. SW Zarich, K Bradley, ID Mayall, LH Bernstein.
Clin Chim Acta 2004; 343(1-2):223-229. ICID: 825515   http://www.ncbi.nlm.nih.gov/pubmed/15115700
[7] GOLDmineR: improving models for classifying patients with chest pain. L Bernstein, K Bradley, SW Zarich. Yale J Biol Med 2002; 75(4):183-198. ICID: 825624
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2588788/

Vasoplegia in Orthotopic Heart Transplant Patients

Posted in Ecosystems & Industrial Concentration in the Medical Device Sector, FDA Regulatory Affairs, International Global Work in Pharmaceutical, Medical Devices R&D and Inventions, Nitric Oxide in Health and Disease, Pharmaceutical Industry Competitive Intelligence, Pharmaceutical R&D Investment, Pharmacotherapy of Cardiovascular Disease, Regulated Clinical Trials: Design, Methods, Components and IRB related issues, Systemic Inflammatory Response Related Disorders, Technology Transfer: Biotech and Pharmaceutical, tagged BMI, cardiothoracic surgery, Cheyne-Stokes Respiration, Conditions and Diseases, Heart Failure, Heart Lung Transplant, Larry H. Bernstein, mechanical support, surgery, thyroid disease, vasoplegia on June 30, 2013| Leave a Comment »

Pre-operative Risk Factors and Clinical Outcomes Associated with Vasoplegia in Recipients of Orthotopic Heart Transplantation in the Contemporary Era.

Writer and Curator: Larry H. Bernstein, MD, FCAP

and

Curator: Aviva Lev-Ari, PhD, RN

Patarroyo M, Simbaqueba C, Shrestha K, Starling RC, Smedira N, Tang WH, Taylor DO.

J Heart Lung Transplant. 2012 Mar;31(3):282-7. http://dx.doi.org/10.1016/j.healun.2011.10.010 Epub 2011 Nov

BACKGROUND: Patients who underwent orthotopic heart transplant (OHT) can develop vasoplegia, which is

associated with high mortality and morbidity.

Herein we examine the per-operative risk in OHT recipients at Cleveland Clinic. Vasoplegic syndrome is

low systemic vascular resistance ( SVR index <1,600 dyn∙seg/cm5/m2 ) and
high cardiac output ( cardiac index >2.5 l/min/m2 )
within the first 4 postoperative hours.

VPS occurs more frequently after on pump CABG surgery versus off pump CABG surgery.

Methylene blue and vasoplegia: who, when, and how?

Stawicki SP, Sims C, Sarani B, Grossman MD, Gracias VH.

Department of Surgery, Division of Surgical Critical Care, University of Pennsylvania School of Medicine

Mini Rev Med Chem. 2008 May;8(5):472-90. http://www.ncbi.nlm.nih.gov/pubmed/18473936

Vasoplegia or vasoplegic syndrome (VS) is thought to be due to

dysregulation of endothelial homeostasis and subsequent endothelial dysfunction
secondary to direct and indirect effects of multiple inflammatory mediators.

Vasoplegia has been observed in all age groups and in various clinical settings, such as anaphylaxis (including protamine reaction), sepsis, hemorrhagic shock, hemodialysis, and cardiac surgery. Among mechanisms thought to be contributory to VS, the nitric oxide (NO)/cyclic guanosine monophosphate (cGMP) pathway appears to play a prominent role.

Methylene blue (MB),

an inhibitor of nitric oxide synthase (NOS) and guanylate cyclase (GC),

has been found to improve

the refractory hypotension associated with endothelial dysfunction of VS.

METHODS: We reviewed peri-operative data from 311 consecutive adult patients who underwent OHT between January 2003 and June 2008.

Vasoplegia was defined as

persistent low systemic vascular resistance,
despite multiple intravenous pressor drugs at high dose,
between 6 and 48 hours after surgery.

RESULTS: In our cohort of 311 patients, 35 (11%) patients developed vasoplegia syndrome; these patients were more likely to be UNOS Status 1A, with

a higher body surface area (1.8 ± 0.25 vs 1.63 ± 0.36, p = 0.0007),
greater history of thyroid disease (38.2% vs 18.5%, p = 0.0075) and
a higher rate of previous cardiothoracic surgery (79% vs 48%, p = 0.0006).

Pre-operatively,

they were more frequently treated with aspirin (73% vs 48%, p = 0.005) and
mechanical assist devices (ventricular assist devices [VADs]: 45% vs 17%, p < 0.0001;
total artificial hearts: 8.6% vs 0%, p < 0.0001), and
less treated with milrinone (14.7% vs 45.8%, p = 0.0005).

Bypass time (118 ± 37 vs 142 ± 39 minutes, p = 0.0002) and

donor heart ischemic time (191 ± 46 vs 219 ± 51 minutes, p = 0.002) were longer, with

higher mortality (3.2% vs 17.1%, p = 0.0003) and morbidity in the first 30 days after transplant.

In the multivariate analysis, history of thyroid disease (odds ratio [OR] = 2.7, 95% CI 1.0 to 7.0, p = 0.04) and VAD prior to transplant (OR = 2.8, 95% CI 1.07 to 7.4, p = 0.03)

were independent risk factors for development of vasoplegia syndrome.

CONCLUSIONS:

High body mass index,
long cardiopulmonary bypass time,
prior cardiothoracic surgery,
mechanical support,
use of aspirin, and
thyroid disease

are risk factors associated with development of vasoplegia syndrome.

Decreased postoperative atrial fibrillation following cardiac transplantation (pharmaceuticalintelligence.com)
6-Year-Old Catonsville Girl Fights For Her Life After Heart Transplant (baltimore.cbslocal.com)
One Year Later, Heart Transplant Recipient Doing Well (foxct.com)
Girl on ventilator after lung transplants (cnn.com)

Heart Failure Treatment Improves, But Death Rate Remains High : NPR (pharmaceuticalintelligence.com)
Heart transplantation research in the next decade – a goal to achieving evidence-based outcomes (pharmaceuticalintelligence.com)
Beta-Blocker Response (23andme.com)
First drug to improve heart failure mortality in over a decade – HealthCanal.com (pharmaceuticalintelligence.com)
Advanced heart failure (pharmaceuticalintelligence.com)
Scientists prevent heart failure in mice (pharmaceuticalintelligence.com)

Mechanical Circulatory Support System, LVAD, RVAD, Biventricular as a Bridge to Heart Transplantation or as “Destination Therapy”: Options for Patients in Advanced Heart Failure

Posted in Cardiac & Vascular Repair Tools Subsegment, Cardiac and Cardiovascular Surgical Procedures, Ecosystems & Industrial Concentration in the Medical Device Sector, FDA Regulatory Affairs, Frontiers in Cardiology and Cardiovascular Disorders, Health Economics and Outcomes Research, Heart Transplant, Human Immune System in Health and in Disease, International Global Work in Pharmaceutical, Medical Devices R&D and Inventions, Medical Devices R&D Investment, Pharmaceutical Industry Competitive Intelligence, Pharmaceutical R&D Investment, Pharmacotherapy of Cardiovascular Disease, Regulated Clinical Trials: Design, Methods, Components and IRB related issues, Stem Cells for Regenerative Medicine, Systemic Inflammatory Response Related Disorders, Technology Transfer: Biotech and Pharmaceutical, tagged Artificial heart, Circulatory system, Coronary artery disease, Food and Drug Administration, Heart Failure, Heart transplantation, Organ transplantation, Total Artificial Heart, Ventricular assist device on June 30, 2013| 4 Comments »

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

Writer and Curator: Larry H. Bernstein, MD, FCAP

and

Curator: Aviva Lev-Ari, PhD, RN

UPDATED on 10/22/2018

HeartMate 3 gets FDA approval for extended use

Revamped Abbott Labs device is seen as an option for cardiac patients who are unlikely to get transplants.

By Joe Carlson Star Tribune

OCTOBER 19, 2018 — 8:09PM

“When heart failure (HF) progresses to an advanced stage, difficult decisions must be made,” the AHA says on its website. “Do I want to receive aggressive treatment? Is quality of life more important than living as long as possible? How do I feel about resuscitation?”

LVADs can take over the pumping function of a failing heart, but they also present some of the most expensive implantable-device surgeries. An article in the peer-reviewed journal JACC: Heart Failure reported last year that the average total cost to implant an LVAD in Medicare beneficiaries was $175,000, more than double the cost of a heart transplant.

Amador said between 5,000 and 5,500 Americans will have LVAD implants this year. That compares with 2,200 adult heart transplants that happen annually in the U.S., according to the JACC article.

SOURCE

http://www.startribune.com/heartmate-3-gets-fda-approval-for-extended-use/498061451/

Starling RC.
Cleve Clin J Med. 2013 Jan; 80(1):33-40. http://dx.doi.org/10.3949/ccjm.80gr.12003

For patients with advanced heart failure, outcomes are good after heart transplantation, but not enough donor hearts are available. Fortunately, mechanical circulatory assist devices have become an excellent option and should be considered either as a bridge to transplantation or as “destination therapy.” Current mechanical circulatory assist devices improve quality of life in patients who are candidates.

For some patients, conventional treatments are inadequate to relieve the effects of heart failure. Under these circumstances, mechanical circulatory support is considered. There are now a variety of devices capable of pumping blood to restore circulation of vital organs, even temporarily replacing the function of the native heart.

The ABIOMED AB5000™ Circulatory Support System is a short-term mechanical system that can provide left, right, or biventricular support for patients whose hearts have failed but have the potential for recovery. The AB5000™ can be used to support the heart, giving it time to rest – and potentially recover native heart function. The device can also be used as a bridge to definitive therapy.

http://med.umich.edu/cardiac-surgery/images/content/Abiomed_AB5000.jpg

CardioWest™ temporary Total Artificial Heart (TAH-t) http://www.syncardia.com/cardiowesttaht/index.php
This medical device is the modern version of the Jarvik 7 artificial heart first implanted into Barney Clark in 1982. The CardioWest™ temporary Total Artificial Heart is the only FDA approved temporary total artificial heart in the world.
The TAH-t is used as a bridge to heart transplant for eligible patients suffering from end-stage biventricular failure.
http://med.umich.edu/cardiac-surgery/images/content/Cardiowest_TAHt_Photo.jpg

Phrenic Nerve Stimulation in Patients with Cheyne-Stokes Respiration and Congestive Heart Failure (pharmaceuticalintelligence.com)
First drug to improve heart failure mortality in over a decade – HealthCanal.com (pharmaceuticalintelligence.com)
The Latest Artificial Heart: Part Cow, Part Machine (technologyreview.com)
Beta-Blocker Response (23andme.com)
Scientists prevent heart failure in mice (pharmaceuticalintelligence.com)
Death Rates Among Advanced Heart Failure Patients Decline Due to Increased Availability of New Therapies (medindia.net)
Heart Failure Treatment Improves, But Death Rate Remains High : NPR (pharmaceuticalintelligence.com)
Common Supplement May Help Patients Fight Heart Failure (news.health.com)

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

Posted in Ecosystems & Industrial Concentration in the Medical Device Sector, FDA Regulatory Affairs, Frontiers in Cardiology and Cardiovascular Disorders, Health Economics and Outcomes Research, Heart Transplant, Human Immune System in Health and in Disease, International Global Work in Pharmaceutical, Medical Devices R&D Investment, Pharmaceutical R&D Investment, Regulated Clinical Trials: Design, Methods, Components and IRB related issues, Technology Transfer: Biotech and Pharmaceutical, tagged Cardiovascular Disorders, Cheyne-Stokes Respiration, evidence based medicine, Heart Failure, Heart transplantation, Larry H. Bernstein, medicine, Organ transplantation on June 30, 2013| 2 Comments »

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

Writer and Curator: Larry H Bernstein, MD, FCAP

and

Curator: Aviva Lev-Ari, PhD, RN

Heart transplantation research in the next decade–a goal to achieving evidence-based outcomes: National Heart, Lung, And Blood Institute Working Group.

Shah MR, Starling RC, Schwartz Longacre L, Mehra MR; Working Group Participants.

J Am Coll Cardiol. 2012 Apr 3;59(14):1263-9. http://dx.doi.org/10.1016/j.jacc.2011.11.050 Review

The National Heart, Lung, and Blood Institute (NHLBI) convened a Working Group (WG) on August 5 to 6, 2010 in Bethesda, Maryland to discuss future directions of research in heart transplantation (HT). The WG was composed of researchers with expertise in the basic science, clinical science, and epidemiological aspects of advanced heart failure and HT.

These experts were asked to

identify the highest priority research gaps in the field and
make recommendations for future research strategies.

The WG was also asked to include approaches that capitalize on current scientific opportunities and focus on areas that required unique NHLBI leadership. Finally, the WG was charged with developing recommendations that would have short- and long-term impact on the field of HT. The WG participants reviewed key areas in HT and identified the most urgent knowledge gaps.

These gaps were then organized into the following 4 specific research directions:

1) enhanced phenotypic characterization of the pre-transplant population;

2) donor-recipient optimization strategies;

3) individualized immunosuppression therapy; and,

4) investigations of immune and non-immune factors affecting late cardiac allograft outcomes.

Finally, because the HT population is relatively small compared with other patient groups, the WG strongly urged concerted efforts to enroll every transplant recipient into a clinical study and to increase collaborative networks to optimize research in this field.

Teen prospers 17 years after heart transplant (KOB.com)
Decreased postoperative atrial fibrillation following cardiac transplantation (pharmaceuticalintelligence.com)

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

Heart Failure Treatment Improves, But Death Rate Remains High : NPR (A Lev-Ari)
http://pharmaceuticalintelligence.com/2013/05/29/heart-failure-treatment-improves-but-death-rate-remains-high-npr/

The Heart: Vasculature Protection – A Concept-based Pharmacological Therapy including THYMOSIN (Aviva Lev-Ari)
http://pharmaceuticalintelligence.com/2013/02/28/the-heart-vasculature-protection-a-concept-based-pharmacological-therapy-including-thymosin/

Resident-cell-based Therapy (Aviva Lev-Ari)
http://pharmaceuticalintelligence.com/2012/04/30/93/

Amyloidosis with Cardiomyopathy (larryhbern)
http://pharmaceuticalintelligence.com/2013/03/31/amyloidosis-with-cardiomyopathy/

Blood-vessels-generating stem cells discovered (ritu.saxena)
http://pharmaceuticalintelligence.com/2012/10/22/blood-vessel-generating-stem-cells-discovered/

Stem Cell Research — The Frontier is at the Technion in Israel (A Lev-Ari)
http://pharmaceuticalintelligence.com/2012/09/06/stem-cell-research-the-frontier-is-at-the-technion-in-israel/

First drug to improve heart failure mortality in over a decade – HealthCanal.com (A Lev-Ari)
http://pharmaceuticalintelligence.com/2013/06/03/first-drug-to-improve-heart-failure-mortality-in-over-a-decade-healthcanal-com/

Scientists prevent heart failure in mice (Aviva Lev-Ari)
http://pharmaceuticalintelligence.com/2013/05/29/scientists-prevent-heart-failure-in-mice/

Stenosis, ischemia and heart failure (Aviva Lev-Ari)
http://pharmaceuticalintelligence.com/2013/05/16/stenosis-ischemia-and-heart-failure/

Heart Remodeling by Design – Implantable Synchronized Cardiac Assist Device: Abiomed’s Symphony (A lev-Ari)
http://pharmaceuticalintelligence.com/2012/07/23/heart-remodeling-by-design-implantable-synchronized-cardiac-assist-device-abiomeds-symphony/

First case in the US: Valve-in-Valve (Aortic and Mitral) Replacements with Transapical Transcatheter Implants – The Use of Transfemoral Devices (larryhbern)
http://pharmaceuticalintelligence.com/2013/06/23/valve-in-valve-replacements-with-transapical-transcatheter-implants/
Ventricular Assist Device (VAD): A Recommended Approach to the Treatment of Intractable

Cardiogenic Shock (larryhbern)
http://pharmaceuticalintelligence.com/2013/06/18/a-recommended-approach-to-the-treatmnt-of-intractable-cardiogenic-shock/

Forrester-classification for classification of Congestive heart failure ; Forrester-Klassifikation zur Einteilung einer akuten Herzinsuffizienz (Photo credit: Wikipedia)

Artificial heart: JARVIK-7 Heart, provided to the National Heart, Lung and Blood Institute (NHLBI) by the University of Utah. (Photo credit: Wikipedia)

Schematic of a transplanted heart with native lungs and the great vessels. (Photo credit: Wikipedia)

English: Ventricular assist device (Photo credit: Wikipedia)

Read Full Post »

Carotid Endarterectomy (CEA) vs. Carotid Artery Stenting (CAS): Comparison of CMMS high-risk criteria on the Outcomes after Surgery: Analysis of the Society for Vascular Surgery (SVS) Vascular Registry Data

Posted in Carotid Artery, Cerebrovascular and Neurodegenerative Diseases, Chemical Biology and its relations to Metabolic Disease, International Global Work in Pharmaceutical, ISO 10993 for Product Registration: FDA & CE Mark for Development of Medical Devices and Diagnostics, Medical Devices R&D and Inventions, Medical Devices R&D Investment, Medical Imaging Technology, Image Processing/Computing, MRI, CT, Nuclear Medicine, Ultra Sound, Peripheral Arterial Disease & Peripheral Vascular Surgery, Pharmaceutical Industry Competitive Intelligence, Stents & Tools, Technology Transfer: Biotech and Pharmaceutical, tagged American Society of Anesthesiologists, Carotid endarterectomy, CEA, Confidence interval, Harvard Medical School, Heart Failure, Medicare, Vascular surgery on June 28, 2013| 4 Comments »

Carotid Endarterectomy (CEA) vs. Carotid Artery Stenting (CAS): Comparison of CMMS high-risk criteria on the Outcomes after Surgery: Analysis of the Society for Vascular Surgery (SVS) Vascular Registry Data

Writer and Curator: Larry H. Bernstein, MD, FCAP

and

Curator: Aviva Lev-Ari, PhD, RN

UPDATED on 1/30/2024

Dr. Gary Roubin | Inside the Studio w/ Drs. Joseph Rogers & Zvonimir Krajcer

The Texas Heart Institute

WATCH Video

https://youtu.be/KobPZLWmLfQ?si=LUxy1gD9fCptj1E7

This week on Inside the Studio, both Dr. Joseph Rogers and Dr. Zvonimir Krajcer sit down with the 2024 Ray C. Fish Award Recipient Dr. Gary S. Roubin to discuss “Carotid Stenting: State of the Art.” Don’t miss out on our upcoming live talks, or catch up on previous recordings at https://www.texasheart.org/grandrounds.

Show the Transcript

https://www.youtube.com/watch?v=KobPZLWmLfQ

UPDATED on 9/25/2021

1-Year Results From a Prospective Experience on CAS Using the CGuard Stent System: The IRONGUARD 2 Study

Peripheral

J Am Coll Cardiol Intv. 2021 Sep, 14 (17) 1917–1923

Topic(s):

Editorial Comment: Dual-Layered Stents: The New Standard for Carotid Stenting?^∗

Abstract

Objectives

The aim of this study was to evaluate the 1-year safety and efficacy of a dual-layered stent (DLS) for carotid artery stenting (CAS) in a multicenter registry.

Background

DLS have been proved to be safe and efficient during short-term follow-up. Recent data have raised the concern that the benefit of CAS performed with using a DLS may be hampered by a higher restenosis rate at 1 year.

Methods

From January 2017 to June 2019, a physician-initiated, prospective, multispecialty registry enrolled 733 consecutive patients undergoing CAS using the CGuard embolic prevention system at 20 centers. The primary endpoint was the occurrence of death and stroke at 1 year. Secondary endpoints were 1-year rates of transient ischemic attack, acute myocardial infarction, internal carotid artery (ICA) restenosis, in-stent thrombosis, and external carotid artery occlusion.

Results

At 1 year, follow-up was available in 726 patients (99.04%). Beyond 30 days postprocedure, 1 minor stroke (0.13%), four transient ischemic attacks (0.55%), 2 fatal acute myocardial infarctions (0.27%), and 6 noncardiac deaths (1.10%) occurred. On duplex ultrasound examination, ICA restenosis was found in 6 patients (0.82%): 2 total occlusions and 4 in-stent restenoses. No predictors of target ICA restenosis and/or occlusion could be detected, and dual-antiplatelet therapy duration (90 days vs 30 days) was not found to be related to major adverse cardiovascular event or restenosis occurrence.

Conclusions

This real-world registry suggests that DLS use in clinical practice is safe and associated with minimal occurrence of adverse neurologic events up to 12-month follow-up.

SOURCE

https://www.jacc.org/doi/10.1016/j.jcin.2021.05.045

UPDATED on 8/5/2020

USPSTF advises against carotid artery stenosis screening

By Theresa Pablos, AuntMinnie staff writer

August 5, 2020 — The U.S. Preventive Services Task Force (USPSTF) is poised to once again recommend against screening for asymptomatic carotid artery stenosis. The task force reaffirmed its D rating in a draft recommendation statement published on August 4.

The USPSTF last weighed in on the topic in 2014, concluding with moderate certainty that the harms of screening for carotid artery stenosis in the general population outweighed the benefits. In its new draft recommendation statement, the agency reaffirmed that position, stating there was not enough new evidence to change its previous recommendation against screening with either carotid duplex ultrasound, CT angiography, or MR angiography.

“The USPSTF found no new substantial evidence that could change its recommendation and therefore reaffirms its recommendation,” the task force wrote.

In theory, screening the general population for stenosis could lead to early detection of narrowed blood vessels, thus enabling medical professionals to conduct potentially life-saving interventions, such as carotid endarterectomy (CEA) and carotid artery stenting (CAS). But the USPSTF concluded that the evidence it reviewed didn’t readily support that hypothesis.

The task force has consistently found limited evidence in favor of asymptomatic carotid artery stenosis screening, especially when compared with other medical therapies, such as statins and antihypertensive agents. And the evidence has been particularly lacking since the USPSTF’s last review in 2014.

USPSTF draft recommendation rationale for asymptomatic carotid artery stenosis

Detection Ultrasonography has reasonable sensitivity and specificity for detecting clinically relevant carotid artery stenosis, but it also yields many false-positive results in the general population.

Scanning the neck for carotid bruits has poor accuracy for clinically relevant carotid artery stenosis.

Benefits Direct evidence does not indicate that screening for asymptomatic carotid artery stenosis can improve stroke, mortality, or other adverse health outcomes.

Carotid endarterectomy (CEA) or carotid artery angioplasty and stenting (CAS) provides little or no benefit for improving stroke, myocardial infarction, mortality, or other adverse outcomes compared with current medical therapy.

Harms While direct evidence does not show that screening for asymptomatic carotid artery stenosis can cause harm, there are known harms with confirmatory testing and interventions.

Direct evidence supports that treating asymptomatic patients with CEA or CAS could cause harms, including stroke or death.

Harms related to screening and treating asymptomatic carotid artery stenosis have small-to-moderate magnitude.

After searching the scientific literature, USPSTF investigators found no recent eligible studies that directly investigated the benefits or harms of asymptomatic carotid artery stenosis screening. The two studies that were conducted on the topic in the past six years were both prematurely terminated and produced mixed results.

When looking at the benefits and harms of CEA or CAS, the authors found an additional two national datasets and three surgical registries that met their inclusion criteria. Rates of 30-day postoperative stroke or death after CEA ranged from 1.4% to 3.5% depending on the registry or database. Similarly, 30-day stroke or death after CAS ranged from 2.6% to 5.1%.

Based on the evidence — or lack thereof — the investigators concluded there wasn’t enough new information to change the D rating for asymptomatic carotid artery stenosis screening. However, they pointed out that two clinical trials are currently underway, which may shed light on the topic in the future.

“There were few new trials, all with methodologic concerns, examining the important question of the comparative effectiveness and harms of revascularization plus best medical treatment compared with best medical treatment alone,” they wrote. “The ongoing CREST-2 and ECST-2 trials will be the largest trials to address this issue.”

The draft recommendation is available for public comment through August 31. After the comment period has ended, the task force will publish its final recommendation.

If you like this content, please share it with a colleague!

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SOURCE

https://www.auntminnie.com/index.aspx?sec=sup&sub=ult&pag=dis&ItemID=129787

UPDATED on 8/20/2018

Transcarotid Artery Revascularization Shows Favorable Outcomes in Patients With Carotid Artery Disease

First large body of real-world clinical evidence showing benefits of TCAR versus surgery presented at SVS 2018 Annual Meeting

July 30, 2018 — Silk Road Medical Inc. recently announced the presentation of real-world data for the treatment of patients with carotid artery disease at risk for stroke at the Society for Vascular Surgery 2018 Vascular Annual Meeting (VAM), June 20-23 in Boston. In a headline presentation, Marc Schermerhorn, M.D., of Beth Israel Deaconess Medical Center (Boston) shared, for the first time, results from the ongoing TransCarotid Artery Revascularization (TCAR) Surveillance Project, a key initiative of the Society for Vascular Surgery’s Vascular Quality Initiative (VQI).

The trial evaluated patients over a two-year period, with 1,182 patients receiving TCAR compared to 10,797 patients receiving carotid endarterectomy (CEA).

“Our overall findings showed that while patients receiving TCAR were sicker and more likely to be symptomatic with a higher degree of stenosis, the stroke and death rate compared to CEA was the same,” Schermerhorn said. “With TCAR, there were significantly lower cranial nerve injuries, less time spent in the operating room and fewer patients with a prolonged length of stay. I believe that clinicians should more widely adopt the TCAR technology as it has demonstrated both safety and efficacy and is an excellent alternative to CEA.”

Significant findings from the study showed TCAR to have:

Comparable rates of in-hospital stroke or death to CEA (TCAR, 1.6 percent; CEA, 1.4 percent, p=.33);

Lower rates of acute cranial nerve injury (TCAR, 0.6 percent; CEA, 1.8 percent, p<.001);

Shorter operative times (TCAR, 78 min; CEA, 111 min, p<.001); and

Shorter hospital stays, despite patients being older and sicker (percent of hospitals stays longer than one night: TCAR, 27%; CEA, 30%, p=0.046).

TCAR is a clinically proven procedure combining surgical principles of neuroprotection with minimally invasive endovascular techniques to treat blockages in the carotid artery at risk of causing a stroke. The TCAR Surveillance Project is the largest single body of evidence reported since the launch of TCAR in 2016.

Additional TCAR presentations highlighted at SVS VAM 2018 demonstrated similar results:

“Vascular Live: Latest Stroke Prevention Data Signals Standard of Care Potential in Carotid Revascularization” provided an interim update on the ROADSTER 2 Per Protocol data set. The ROADSTER 2 trial is a post-market study intended to enroll a minimum of 600 patients and with at least 70 percent enrollment completed by newly trained operators. Peter Schneider, M.D., of Kaiser Permanente (Honolulu) and co-principal investigator for the ROADSTER 2 trial, presented interim results on 470 patients. Schneider highlighted a 30-day stroke rate of 0.6 percent and a stroke/death rate of 0.9 percent, consistent with the outcomes seen in the pivotal ROADSTER trial.

“A Multi-Institutional Analysis of Contemporary Outcomes after TransCarotid Artery Revascularization versus Carotid Endarterectomy” compared outcomes of TCAR to CEA across four institutions. Alex King of University Hospitals Cleveland Medical Center (Ohio) presented results showing that patients undergoing TCAR (n=292), had similar 30-day stroke rates (TCAR, 1 percent; CEA, 1.1 percent, p=1.00) compared with patients undergoing CEA (n=371), despite being more likely to have significant comorbidities. Acute (TCAR, 0.3 percent; CEA, 4.1 percent, p<.01) and six-month cranial nerve injury rates (TCAR, 0 percent; CEA: 1.9 percent, p=0.02) were shown to be lower with TCAR vs CEA.

The Enroute Transcarotid Stent is intended to be used in conjunction with the Enroute Transcarotid Neuroprotection System (NPS) during the TCAR procedure. The Enroute Transcarotid NPS is used to directly access the common carotid artery and initiate high rate temporary blood flow reversal to protect the brain from stroke while delivering and implanting the Enroute Transcarotid Stent.

For more information: www.silkroadmed.com

This is a review of the impact of the Centers for Medair and Medicaid Services on carotid artery endovascular outcomes carried out by the Division of Vascular and Endovascular Surgery at Harvard Medical School, Partners.

The impact of Centers for Medicare and Medicaid Services high-risk criteria on outcome after carotid endarterectomy and carotid artery stenting in the SVS Vascular Registry.

Schermerhorn ML, Fokkema M, Goodney P, Dillavou ED, Jim J, Kenwood CT, Siami FS, White RA; SVS Outcomes Committee.

Beth Israel Deaconess Medical Center, Boston, Mass, USA.

J Vasc Surg. 2013 May;57(5):1318-24. http://dx.doi.org/10.1016/j.jvs.2012.10.107. Epub 2013 Feb 11.

The Centers for Medicare and Medicaid Services (CMS) require high-risk (HR) criteria for carotid artery stenting (CAS) reimbursement. The impact of these criteria on outcomes after carotid endarterectomy (CEA) and CAS remains uncertain. Additionally, if these HR criteria are associated with more adverse events after CAS, then existing comparative effectiveness analysis of CEA vs CAS may be biased. We sought to elucidate this using data from the SVS Vascular Registry.

We analyzed 10,107 patients undergoing CEA (6370) and CAS (3737), stratified by CMS HR criteria. The primary endpoint was composite death, stroke, and myocardial infarction (MI) (major adverse cardiovascular event [MACE]) at 30 days. We compared baseline characteristics and outcomes using univariate and multivariable analyses.

CAS patients were more likely than CEA to have

preoperative stroke (26% vs 21%) or
transient ischemic attack (23% vs 19%) .

Although age ≥ 80 years was similar, CAS patients were more likely to have all other HR criteria.

For CEA, HR patients had higher MACEs than normal risk in both

symptomatic (7.3% vs 4.6%; P < .01) and
asymptomatic patients (5% vs 2.2%; P < .0001).

For CAS, HR status was not associated with a significant increase in MACE for

symptomatic (9.1% vs 6.2%; P = .24) or
asymptomatic patients (5.4% vs 4.2%; P = .61).

All CAS patients had MACE rates similar to HR CEA. After multivariable risk adjustment, CAS had higher rates than CEA

for MACE (odds ratio [OR], 1.2; 95% confidence interval [CI], 1.0-1.5),
death (OR, 1.5; 95% CI, 1.0-2.2), and
stroke (OR, 1.3; 95% CI,1.0-1.7),

whereas there was no difference in MI (OR, 0.8; 95% CI, 0.6-1.3).

Among CEA patients, MACE was predicted by:

age ≥ 80 (OR, 1.4; 95% CI, 1.02-1.8),
congestive heart failure (OR, 1.7; 95% CI, 1.03-2.8),
EF <30% (OR, 3.5; 95% CI, 1.6-7.7),
angina (OR, 3.9; 95% CI, 1.6-9.9),
contralateral occlusion (OR, 3.2; 95% CI, 2.1-4.7), and
high anatomic lesion (OR, 2.7; 95% CI, 1.33-5.6).

Among CAS patients, recent MI (OR, 3.2; 95% CI, 1.5-7.0) was predictive, and

radiation (OR, 0.6; 95% CI, 0.4-0.8) and
restenosis (OR, 0.5; 95% CI, 0.3-0.96) …..were protective for MACE

Although CMS HR criteria can successfully discriminate a group of patients at HR for adverse events after CEA, certain CMS HR criteria are more important than others. However, CEA appears safer for the majority of patients with carotid disease. Among patients undergoing CAS, non-HR status may be limited to restenosis and radiation.

This study was preceded by another publication 5-years earlier involving ML Schermerhorn, of the study above.

Risk-adjusted 30-day outcomes of carotid stenting and endarterectomy: results from the SVS Vascular Registry.

Sidawy AN, Zwolak RM, White RA, Siami FS, Schermerhorn ML, Sicard GA; Outcomes Committee for the Society for Vascular Surgery.

Department of Surgery, Washington VA Medical Center, Washington, DC, USA.

J Vasc Surg. 2009 Jan;49(1):71-9. http:/dx.doi.org/10.1016/j.jvs.2008.08.039. Epub 2008 Nov 22.

As of December 26, 2007, 6403 procedures with discharge data were entered by 287 providers at 56 centers on 2763 CAS patients (1450 with 30-day outcomes, 52.5%) and 3259 CEA patients (1368 with 30-day outcomes, 42%).

Of the total cohort, 98% of CEA and 70.7% of CAS (P < .001) were performed for atherosclerotic disease.

Restenosis accounted for 22.3% and
post-radiation induced stenosis in 4.5% of CAS patients.

Preprocedure lateralizing neurologic symptoms were present in a greater proportion of – CAS patients (49.2%) than CEA patients (42.4%, P < .001).

CAS patients also had higher preprocedure prevalence of

coronary artery disease (CAD),
MI,
congestive heart failure (CHF),
chronic obstructive pulmonary disease (COPD), and
cardiac arrhythmia.

For CAS, death/stroke/MI at 30 days was

7.13% for symptomatic patients and 4.60% for asymptomatic patients (P = .04).

For CEA, death/stroke/MI at 30 days was

3.75% in symptomatic patients and 1.97% in asymptomatic patients (P = .05).

After risk-adjustment for age, history of stroke, diabetes, and American Society of Anesthesiologists (ASA) grade (ie, factors found to be significant confounders in outcomes using backwards elimination),

logistic regression analysis suggested better outcomes following CEA.

When CAS and CEA were compared in the treatment of atherosclerotic disease only, the difference in outcomes between the two procedures was more pronounced, with

death/stroke/MI 6.42% after CAS vs 2.62% following CEA, P < .0001.

With continued enrollment and follow-up, analysis of SVS-VR will supplement randomized trials by providing real-world comparisons of CAS and CEA with sufficient numbers to serve as an outcome assessment tool of important patient subsets and across the spectrum of peripheral vascular procedures.

J Vasc Surg. 2012 May;55(5):1313-20; discussion 1321. doi: 10.1016/j.jvs.2011.11.128. Epub 2012 Mar 28.

Society for Vascular Surgery (SVS) Vascular Registry evaluation of comparative effectiveness of carotid revascularization procedures stratified by Medicare age.

Jim J, Rubin BG, Ricotta JJ 2nd, Kenwood CT, Siami FS, Sicard GA; SVS Outcomes Committee.

Collaborators (10)

Source

Washington University School of Medicine, St. Louis, Mo., USA.

Abstract

OBJECTIVE:

Recent randomized controlled trials have shown that age significantly affects the outcome of carotid revascularization procedures. This study used data from the Society for Vascular Surgery Vascular Registry (VR) to report the influence of age on the comparative effectiveness of carotid endarterectomy (CEA) and carotid artery stenting (CAS).

METHODS:

VR collects provider-reported data on patients using a Web-based database. Patients were stratified by age and symptoms. The primary end point was the composite outcome of death, stroke, or myocardial infarction (MI) at 30 days.

RESULTS:

As of December 7, 2010, there were 1347 CEA and 861 CAS patients aged < 65 years and 4169 CEA and 2536 CAS patients aged ≥ 65 years. CAS patients in both age groups were more likely to have a disease etiology of radiation or restenosis, be symptomatic, and have more cardiac comorbidities. In patients aged <65 years, the primary end point (5.23% CAS vs 3.56% CEA; P = .065) did not reach statistical significance. Subgroup analyses showed that CAS had a higher combined death/stroke/MI rate (4.44% vs 2.10%; P < .031) in asymptomatic patients but there was no difference in the symptomatic (6.00% vs 5.47%; P = .79) group. In patients aged ≥ 65 years, CEA had lower rates of death (0.91% vs 1.97%; P < .01), stroke (2.52% vs 4.89%; P < .01), and composite death/stroke/MI (4.27% vs 7.14%; P < .01). CEA in patients aged ≥ 65 years was associated with lower rates of the primary end point in symptomatic (5.27% vs 9.52%; P < .01) and asymptomatic (3.31% vs 5.27%; P < .01) subgroups. After risk adjustment, CAS patients aged ≥ 65 years were more likely to reach the primary end point.

CONCLUSIONS:

Compared with CEA, CAS resulted in inferior 30-day outcomes in symptomatic and asymptomatic patients aged ≥ 65 years. These findings do not support the widespread use of CAS in patients aged ≥ 65 years.

http://www.ncbi.nlm.nih.gov/pubmed/22459755

Blood-brain barrier disruption is associated with increased mortality after endovascular therapy. (zedie.wordpress.com)
Monmouth Stroke Service Success Story: Great outcome after emergent carotid endartercomy (mmcneuro.wordpress.com)
The EVAR II trial: Endovascular approach when unfit for open aortic aneurysm repair [Classics Series] (2minutemedicine.com)
Carotid Artery Disease (Part 3 of 3) (pampv.wordpress.com)
Vascular Surgery – Treating Vascular Problems through Surgery (diabetesexpert.wordpress.com)
The EVAR I trial: Endovascular vs. open abdominal aortic aneurysm repair [Classics Series] (2minutemedicine.com)
Arteries in Your Head & Neck (dumlerdental.wordpress.com)
Serum Carotenoids Reduce Progression of Early Atherosclerosis in the Carotid Artery Wall among Eastern Finnish Men (plosone.org)
Carotid Artery Disease (Part 1 of 3) (pampv.wordpress.com)
Carotid Artery Disease (Part 2 of 3) (pampv.wordpress.com)

First case in the US: Valve-in-Valve (Aortic and Mitral) Replacements with Transapical Transcatheter Implants – The Use of Transfemoral Devices

Posted in Aortic Valve: TAVR, TAVI vs Open Heart Surgery, Cardiac & Vascular Repair Tools Subsegment, Cardiac and Cardiovascular Surgical Procedures, Ecosystems & Industrial Concentration in the Medical Device Sector, Frontiers in Cardiology and Cardiovascular Disorders, ISO 10993 for Product Registration: FDA & CE Mark for Development of Medical Devices and Diagnostics, Mitral Valve: Repair and Replacement, Valve-in-Valve Procedure, Valves & Tools, tagged Edwards, Edwards Lifescience, Edwards Lifesciences Corporation, Heart Failure, Heart valve, Mitral valve, Valve on June 23, 2013| 4 Comments »

First case in the US: Valve-in-Valve (Aortic and Mitral) Replacements with Transapical Transcatheter Implants – The Use of Transfemoral Devices

Writer: Larry H Bernstein, MD, FCAP

and

Curator: Aviva Lev-Ari, PhD, RN

UPDATED on 9/24/2018

TCT: Long-Term Data Reassuring for Valve-in-Valve TAVR

New valve performs well through 3 years

by Nicole Lou, Contributing Writer, MedPage Today

September 23, 2018

Transcatheter valve-in-valve replacement had lasting benefits in a high-risk patient population requiring valve reintervention, registry data showed.

Starting with 365 patients who got valve-in-valve transcatheter aortic valve replacement (TAVR), death took its toll in 12.1%, 22.2%, and 32.7% by 12, 24, and 36 months, respectively. Stroke and repeat valve replacement had plateaued to 5.1% and 0.6% over 24 months, rising to 6.2% and 1.9% at the 36-month mark.

Valve performance was sustained the whole time, as effective orifice area had a significant boost from baseline to discharge, staying stable thereafter out to 3 years; mean gradient dropped after the procedure and similarly stayed unchanged over time, according to John Webb, MD, of St. Paul’s Hospital in Vancouver, at the Transcatheter Cardiovascular Therapeutics (TCT) conference.

Among survivors, early improvements in functional status were also maintained over the 3-year period, Webb said. Most patients started off in New York Heart Association class 3 and 4 and were reclassified as class 1 and 2 after TAVR. Quality of life also was better, as shown in improved Kansas City Cardiomyopathy Questionnaire overall summary scores: 43.1 at baseline to 70.8 at 30 days (P<0.0001), and staying stable out to 3 years.

The results were not influenced by surgical valve size, failure mode, approach, or residual gradient.

These data are “certainly reassuring out 2-3 years” but the concern lies in anticipation of lower-risk and younger patients who are expected to start getting TAVR in the future, commented Stephan Windecker, MD, of the University of Bern in Switzerland, who was a panelist at the TCT late-breaker trial session.

There are some concerns regarding coronary obstruction, Webb acknowledged. “This is true in surgical valves and it would be every bit as true in transcatheter valves, if not more so.”

Primary Source

Transcatheter Cardiovascular Therapeutics

Source Reference: Webb JG “Late follow-up from the PARTNER aortic valve-in-valve registry” TCT 2018.

SOURCE

https://www.medpagetoday.com/meetingcoverage/tct/75261?xid=nl_mpt_ACC_Reporter_2018-09-23&eun=g5099207d2r

UPDATED on 4/13/2014

Replacement of the Mitral Valve: Using the Edwards’ Sapien Aortic Valve Device

http://pharmaceuticalintelligence.com/2014/04/10/replacement-of-the-mitral-valve-using-the-edwards-sapien-aortic-valve-device/

June 23, 2013

The following is a report of the first case in the US of both aortic and mitral valve transcatheter replacements using transfemoral devices via the transapical approach.

It is part of a series on the cardiovascular team at the Columbia Univarsity Medical Center/New York Presbyterian Hospital and the Cardiovascular Research Foundation in the Partner trial.

Concomitant Transcatheter Aortic and Mitral Valve-in-Valve Replacements Using Transfemoral Devices Via the Transapical Approach

Paradis J-M, Kodali SK, Hahn RT, George I, Daneault B, et al.
ColumbiaUniversityMedicalCenter/NewYork-Presbyterian Hospital, New York, NY fJACC:CARDIOVASCULARINTERVENTIONS 2013;6(1):94-96
http://dx.doi.org/10.1016/j.jcin.2012.07.018

Case Presentation

This is an 85 year old man with congestive heart failure (CHF) NYHA class III/IV and hemolytic anemia. He had a previous history of S. viridans bacterial endocarditis that caused severe aortic and mitral regurgitations. Both aortic and mitral valves were replaced in 2002. A recenttTransesophageal echocardiogram (TEE) showed the left ventricular ejection fraction (LVEF) was 55%. This was related to severe mitral regurgitation caused by a flail leaflet, and its internal diameters measured 21-23.8 mm. There was, in addition, severe stenosis of the Carpentir-Edwards valve in the aortic position with an aortic valve area (AVA) of only 0.9 cm, which was 24 mm internal diameter measured by 3-D TEE.

Action Taken

The patient was felt to require reoperative aortic and mitral valve replacements, but he was deemed inoperable by 2 cardiothoracic surgeons. Therefore they decided to proceed with transapical transcatheter double valve-in-valve implantation using 2 commercially available RetroFlex 3 transfemoral devices (Edwards Lifesciences, Irvine, CA). A 26-mm Edwards SAPIEN transcatheter heart valve (THV) was placed within the Carpentier-Edwards valve in the aortic position without pre-dilatation under rapid ventricular pacing. An Edwards SAPIEN 26-mm THV was then deployed within the Hancock modiﬁed bioprosthesis in the mitral position with a 2-step inflation technique. TEE after deplonment of both valves showed excellent function. The new aortic prosthetic valve had an AVA of 2.08 cm, peak and mean gradients of 12 and 6 mm Hg, respectively, and no aortic insufficiency. The mitral valve area was 1.65 cm, and there was only trace mitral regurgitation.

Figure 1.TEE Showing the Mitral Bioprosthetic Valve

Transesophageal echocardiogram (TEE) demonstrating (A) color Doppler through the mitral bioprosthetic valve. Severe intraprosthetic mitral regurgitation caused by a ﬂail leaﬂet generates an eccentric regurgitant jet (see Online Video1).The effective regurgitant oriﬁce was calculated to be 0.42cm. (B) Measurements of the internal dimensions of the mitral bioprosthesis using 3-dimensional reconstruction imaging.

Figure 2.TEE Showing the Aortic Bioprosthetic Valve.

Transesophageal echocardiogram (TEE) showing (A) planimetry of the oriﬁce and (B) measurement of the internal diameter of the aortic bioprosthesis.

Figure 3.The 4 Prosthetic Heart Valves.

Final ﬂuoroscopic images showing the 4 prosthetic heart valves (Hancock modiﬁed,Carpentier-Edwards, and 2 Edwards SAPIEN transcatheter heart valves) in different angulations

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Phrenic Nerve Stimulation in Patients with Cheyne-Stokes Respiration and Congestive Heart Failure

Posted in Cardiac & Vascular Repair Tools Subsegment, Frontiers in Cardiology and Cardiovascular Disorders, Regulated Clinical Trials: Design, Methods, Components and IRB related issues, Technology Transfer: Biotech and Pharmaceutical, tagged Cheyne-Stokes, Cheyne-Stokes Respiration, CHF, Clinical trial, Conditions and Diseases, CSA, Doctor of Philosophy, health, Heart Failure, Phrenic nerve, Sleep and breathing, Sleep apnea, Zhang Xi on June 20, 2013| 6 Comments »

Phrenic Nerve Stimulation in Patients with Cheyne-Stokes Respiration and Congestive Heart Failure

Writer: Larry H Bernstein, MD, FCAP

and

Curator: Aviva Lev-Ari, PhD, RN

Transvenous Phrenic Nerve Stimulation in Patients With Cheyne-Stokes Respiration and Congestive Heart Failure:A Safety and Proof-of-Concept Study

Xi-Long Zhang, MD; Ning Ding; Hong Wang; Ralph Augostini; Bing Yang; Di Xu; Weizhu Ju; Xiaofeng Hou; Xinli Li; Buqing Ni, PhD; Kejiang Cao; Isaac George; Jie Wang, MD, PhD; Shi-Jiang Zhang

Author and Funding Information

Chest. 2012; 142(4):927-934. doi:10.1378/chest.11-1899

Text Size: A A A

Related editorial/commentary:

Sleep-Disordered Breathing, Heart Failure, and Phrenic Nerve Stimulation (Chest. 2012;142(4):821-823.)

Abstract

Background: Cheyne-Stokes respiration (CSR), which often occurs in patients with congestive heart failure (CHF), may be a predictor for poor outcome. Phrenic nerve stimulation (PNS) may interrupt CSR in patients with CHF. We report the clinical use of transvenous PNS in patients with CHF and CSR.

Methods: Nineteen patients with CHF and CSR were enrolled. A single stimulation lead was placed at the junction between the superior vena cava and brachiocephalic vein or in the left-side pericardiophrenic vein. PNS stimulation was performed using Eupnea System device (RespiCardia Inc). Respiratory properties were assessed before and during PNS. PNS was assessed at a maximum of 10 mA.

Results: Successful stimulation capture was achieved in 16 patients. Failure to capture occurred in three patients because of dislocation of leads. No adverse events were seen under maximum normal stimulation parameters for an overnight study. When PNS was applied following a series of central sleep apneic events, a trend toward stabilization of breathing and heart rate as well as improvement in oxygen saturation was seen. Compared with pre-PNS, during PNS there was a significant decrease in apnea-hypopnea index (33.8 ± 9.3 vs 8.1 ± 2.3, P = .00), an increase in mean and minimal oxygen saturation as measured by pulse oximetry (89.7% ± 1.6% vs 94.3% ± 0.9% and 80.3% ± 3.7% vs 88.5% ± 3.3%, respectively, all P = .00) and end-tidal CO₂ (38.0 ± 4.3 mm Hg vs 40.3 ± 3.1 mm Hg, P = .02), but no significant difference in sleep efficiency (74.6% ± 4.1% vs 73.7% ± 5.4%, P = .36).

Conclusions: The preliminary results showed that in a small group of patients with CHF and CSR, 1 night of unilateral transvenous PNS improved indices of CSR and was not associated with adverse events.

Trial registry: ClinicalTrials.gov; No.: NCT00909259; URL: www.clinicaltrials.gov

http://journal.publications.chestnet.org/article.aspx?articleid=1215995

Transvenous phrenic nerve stimulation in patients with Cheyne-Stokes respiration and congestive heart failure: a safety and proof-of-concept study

Zhang Xi-Long; Ding N, Wang H, Augostini R, Yang B.
CHEST 2012; 142(4):927–934
Trial registry: ClinicalTrials.gov; No.: NCT00909259; URL: http://www.clinicaltrials.gov
http://dx.doi.org/10.1378/chest.11-1899

Introduction

Cheyne-Stokes respiration (CSR), a condition characterized by a cyclic pattern of waxing and waning ventilation interposed by central apneas or hypopneas, may affect up to 40% of patients with congestive heart failure (CHF). Whether CSR is related to significantly increased morbidity and mortality 2 or has no impact on long-term survival in patients with CHF is controversial. Nevertheless, several investigators have reported that CSR might be an independent prognostic index of poor outcome in patients with CHF, so that Cheyne-Stokes respiration (CSR), which often occurs in patients with congestive heart failure (CHF), may be a predictor for poor outcome. CSR in patients with CHF is believed to be associated with a hypersensitivity to arterial CO 2 during sleep. The key pathophysiologic mechanism leading to all forms of periodic breathing is the oscillation of blood CO 2 level below and above the apneic threshold. Clinically, these pathophysiologic changes may translate to sleep fragmentation, excessive daytime sleepiness, reduced exercise capacity, and, possibly, ventricular arrhythmias.

Current treatment options for CSR include medications, positive airway pressure devices such as adapt servo-ventilation, or oxygen therapy. Although all these therapies have shown benefi t in some patients, none has shown a consistent benefi t of suffi cient clinical magnitude to reduce mortality and morbidity. In the current study, we explored the initial feasibility, safety, and possible effects of unilateral, transvenous, synchronized PNS on CSR in 19 patients with CHF . This novel treatment resulted in a marked reduction of minute ventilation and possible improvement of CSR. The authors here suggest that phrenic nerve stimulation (PNS) may interrupt CSR in patients with CHF.

Study Population

Nineteen patients with CHF and CSR were enrolled. All study patients (N 5 19) had received a diagnosis of CSR and chronic CHF and were hospitalized in The First Affiliated Hospital of Nanjing Medical University (Nanjing, China). Of them, 12 with rheumatic cardiac valve disease were waiting forcardiac surgery, and seven (fi ve with dilated cardiomyopathy and two with hypertensive heart disease) were enrolled from the cardiology ward because of severe heart failure.

The inclusion criteria were aimed at identifying patients with symptoms or a diagnosed condition indicative of CSR who would tolerate the testing procedure. The patients continued on their standard medical regimen during participation, and in the case of an adverse event, medical treatment was at the discretion of the investigator. The inclusion criteria were as follows: (1) both patient and direct family member willingness to sign a Patient Ethics Committee-approved informed consent, (2) age > 18 years, (3) index CSR of > 15 times/h, (4) history of CHF with a left ventricle ejection fraction < 45%, and (5) ability to tolerate the study procedure and remain clinically stable for the duration of the study. Exclusion criteria were as follows: (1) baseline oxygen saturation < 90% on a stable FiO2 ; (2) evidence of phrenic nerve palsy; (3) temperature > 38.0°C; (4) inability to place stimulation lead (eg, coagulopathy, distorted anatomy, etc); (5) current enrollment in another clinical study that may confound the results of the present study; (6) no informed consent; (7) pregnancy or of childbearing potential without a negative pregnancy test within 10 days of the study procedure; (8) pacemaker, implantable cardioverter defibrillator, or cardiac resynchronization device; (9) severe COPD; (10) a history of myocardial infarction within 6 months prior to the study; and (11) unstable angina.

Study Design

This short-term, prospective, open-label, nonrandomized feasibility study consisted of a treatment-only cohort in which each patient served as his or her own control. After patients were screened and enrolled in the study, PNS leads were placed through an interventional procedure for observation of 1 night only. During the 1-night study, we examined whether PNS caused pain, arousal during sleep, arrhythmia, changes in BP, and changes in either normal breathing or sleep apnea. We also examined the impact of PNS on central, obstructive, and mixed sleep apnea. Alterations in sleep apnea and hypopnea events were compared before and during PNS. “Before stimulation” was defined as the number of sleep apnea and hypopnea events occurring during a segment of 10 min just before delivery of PNS and served as the control for the effects of PNS. The total number of the 10-min segments before PNS, the total number of sleep apnea and hypopnea events occurred during the sum of the 10-min time were calculated, then averaged (total number of sleep apnea and hypopnea events/total hours of the 10-min segments from all patients) and presented as the apnea-hypopnea index (AHI) for statistical analysis. AHI during PNS were also calculated and compared with AHI prior to PNS.

Sleep Study and Monitored Parameters

All participants underwent a nocturnal, in-laboratory polysomnography (Embla S4500 PSG Amplifi er; Natus Medical Inc) and were monitored for at least 7 h overnight. The standard polysomnography recorded the EEG, bilateral electrooculograms, submental electromyogram, ECG, chest and abdominal movement using respiratory effort bands, body position, nasal airflow using a pressure sensor, and oxygen saturation as measured by pulse oximetry (Sp o 2 ).

EEG, sleep staging, and arousals were monitored and scored using 30 epochs according to the method of Rechtschaffen and Kales. Classification of apnea and hypopnea was described by standard methodologies. CSR was identified as a special kind of CSA behaving as a cyclic pattern of periods of hyperventilation with waxing and waning tidal volumes alternating with periods of central hypopnea/apnea .

Lead Placement and PNS

A single stimulation lead was placed at the junction between the superior vena cava and brachiocephalic vein or in the left-side pericardiophrenic vein. PNS stimulation was performed using Eupnea System device (RespiCardia Inc). Respiratory properties were assessed before and during PNS. PNS was assessed at a maximum of 10 mA.

Results

Successful stimulation capture was achieved in 16 patients. Failure to capture occurred in three patients because of dislocation of leads. No adverse events were seen under maximum normal stimulation parameters for an overnight study. No new arrhythmias, muscle contractions, arterial BP variations, pain, or unpleasant sensations were observed once PNS was delivered during sleep for these patients. It was confirmed that the catheter could be secured adequately to obtain consistent predictable stimulation thresholds without arousal from sleep. During occurrence of CSR, intermittent PNS signals were first confirmed to be successfully captured in 16 patients. When PNS was applied following a series of central sleep apneic events, a trend toward stabilization of breathing and heart rate. An improvement in oxygen saturation and elevation of end-tidal CO2 was observed as longer continuous stimulation was performed. The period of stable breathing lasted as long as 10 to 20 min in some patients after stimulation. They found that when electric connection to the nerve was consistent, stimulation resulted in a reduced hyperventilation followed by the reduction or elimination of CSR.

Compared with pre-PNS, during PNS there was a significant decrease in apnea-hypopnea index (33.8 ± 9.3 vs 8.1 ± 2.3, P = .00), an increase in mean and minimal oxygen saturation as measured by pulse oximetry (89.7% ± 1.6% vs 94.3% ± 0.9% and 80.3% ± 3.7% vs 88.5% ± 3.3%, respectively, all P = .00) and end-tidal CO2 (38.0 ± 4.3 mm Hg vs 40.3 ± 3.1 mm Hg, P = .02), but no significant difference in sleep efficiency (74.6% ± 4.1% vs 73.7% ± 5.4%, P = .36).

Discussion

CSR is characterized by cyclical oscillations of respiration and apnea. The incidence of CSR ranges from 10% to 20% in patients with stable CHF and up to 40% to 50% of all patients with New York Heart Association functional class III?IV CHF. Nocturnal breathing alterations in patients with CHF are believed to be due to hypersensitivity to CO 2 during sleep. Breathing is controlled by a negative feedback system in which an increase in Pa co 2 stimulates breathing, whereas a decrease in Pa co 2 inhibits breathing. Normally, Pa co 2 is maintained within a narrow range. Patients with CHF and CSA have a more brisk ventilatory response to CO 2 than those without CSA.

The preliminary results showed that in a small group of patients with CHF and CSR, 1 night of unilateral transvenous PNS improved indices of CSR and was not associated with adverse events.

The study was performed using temporary catheters or leads in the right-side brachiocephalic vein, SVC, or left-side pericardiophrenic vein to transvenously stimulate the hemidiaphragm through either the leftside or the right-side phrenic nerve. To consistently stimulate the phrenic nerve using acceptable and safe current levels ( < 10 mA), the stimulation electrode needs to be within 2 to 5 mm from the phrenic nerve. This type of stimulation caused significantly improved respiratory parameters in patients with CHF and further support that oscillation of CO 2 level in the blood below and above the apneic threshold is a central mechanism leading to the CSR pattern of breathing. Stabilization of CO 2 levels through PNS produced a regular breathing pattern, improvement in oxygen saturation, and fewer apneic events.

Dr. Isaac George: contributed to data evaluation and drafting of the manuscript.

Hypothyroidism increased mortality risk in patients with congestive HF. (zedie.wordpress.com)

USPSTF draft recommendation rationale for asymptomatic carotid artery stenosis
Detection	Ultrasonography has reasonable sensitivity and specificity for detecting clinically relevant carotid artery stenosis, but it also yields many false-positive results in the general population.
	Scanning the neck for carotid bruits has poor accuracy for clinically relevant carotid artery stenosis.
Benefits	Direct evidence does not indicate that screening for asymptomatic carotid artery stenosis can improve stroke, mortality, or other adverse health outcomes.
	Carotid endarterectomy (CEA) or carotid artery angioplasty and stenting (CAS) provides little or no benefit for improving stroke, myocardial infarction, mortality, or other adverse outcomes compared with current medical therapy.
Harms	While direct evidence does not show that screening for asymptomatic carotid artery stenosis can cause harm, there are known harms with confirmatory testing and interventions.
	Direct evidence supports that treating asymptomatic patients with CEA or CAS could cause harms, including stroke or death.
	Harms related to screening and treating asymptomatic carotid artery stenosis have small-to-moderate magnitude.

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