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Archive for the ‘Aortic Valve: TAVR, TAVI vs Open Heart Surgery’ Category

Off-Label TAVR Procedures: 1 in 10 associated with higher in-hospital 30-day mortality, 1-year mortality was similar in the Off-Lavel and the On-Label groups

Posted in Aortic Valve: TAVR, TAVI vs Open Heart Surgery on June 22, 2017| Leave a Comment »

Off-Label TAVR Procedures: 1 in 10 associated with higher in-hospital 30-day mortality, 1-year mortality was similar in the Off-Label and the On-Label groups

Reporter: Aviva Lev-Ari, PhD, RN

 

UPDATED on 7/10, 2017

FDA clears Medtronic’s CoreValve Evolut TAVR in intermediate risk patients

JULY 10, 2017 BY FINK DENSFORD

http://www.massdevice.com/fda-clears-medtronics-corevalve-evolut-tavr-in-intermediate-risk-patients/?spMailingID=11443122&spUserID=MTU0MTAzNDg3OTA5S0&spJobID=1200865729&spReportId=MTIwMDg2NTcyOQS2

 

 

  • by Nicole Lou, Reporter, MedPage Today/CRTonline.org June 21, 2017

Action Points

  • Off-label transcatheter aortic valve replacement (TAVR) was associated with higher in-hospital, 30-day, and 1-year mortality rates compared with on-label TAVR use, but after adjustment, 1-year mortality was similar in the two groups.
  • Note that approximately one in 10 TAVR patients in the United States have received the procedure for an off-label indication.

Three-quarters of off-label indications were deemed so due to presence of severe aortic or mitral regurgitation or both; one-fifth were off-label because of bicuspid valves.

Successful device implantation was slightly less likely with off-label TAVR (92.9% versus 93.0%, P=0.02). But in-hospital outcomes were the bigger issue for off- versus on-label TAVR:

  • Mortality (6.3% versus 4.7%, P<0.001)
  • Cardiac arrest (6.6% versus 4.8%, P<0.001)
  • Transient ischemic attack (0.5% versus 0.2%, P=0.007)
  • Moderate-to-severe perivalvular leaks (12.4% versus 7.6%, P<0.001)

Mortality was most likely for patients with severe mitral regurgitation as the only off-label indication for TAVR. The authors suggested this is owing to secondary mitral regurgitation caused by left ventricular dilatation.

SOURCE

1 in 10 TAVR Procedures Done Off-Label Despite early risks vs on-label use, ‘acceptable results’ cited from registry

https://www.medpagetoday.com/Cardiology/CHF/66173?xid=nl_mpt_DHE_2017-06-22&eun=g99985d0r&pos=1

Other related TAVR articles published in this Open Access Online Scientific Journal included the following 64 articles:

https://pharmaceuticalintelligence.com/?s=TAVR

 

 

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Tommy King Memorial Cardiovascular Symposium, St. Elizabeth’s Medical Center, Boston, May 20, 2017

Posted in Aortic Valve: TAVR, TAVI vs Open Heart Surgery, Cancer Surgery of the Heart, Cardiac and Cardiovascular Surgical Procedures, Frontiers in Cardiology and Cardiovascular Disorders, PCI, Stents & Tools, Valves & Tools, tagged on April 24, 2017| Leave a Comment »

Tommy King Memorial Cardiovascular Symposium

Reporter: Aviva Lev-Ari, PhD, RN

 

Saturday CEUs in Boston, May 20, 2017

St. Elizabeth’s Medical Center

Boston, MA

May 20

7:30am – 3pm

PROGRAM SCHEDULE & SESSIONS

07:30am | Registration & Continental Breakfast

08:00am | Hemodynamics; Faisal Khan, MD, St. Elizabeth’s Medical Center

09:00am | Radiation Protection; Satish Nair, PhD, F.X. Masse Associates

10:00am | Break & Exhibits

10:15am | Structural Heart – TAVR Updates and Watchman

Joseph Carrozza, MD, St. Elizabeth’s Medical Center

11:15am | Road to the Cath Lab — Triggers for STEMI Activation 

Lawrence Garcia, MD, St. Elizabeth’s Medical Center

12:15pm | Lunch

01:00pm | HF Program including Cardiomems

Lana Tsao, MD & Jaclyn Mayer, NP, St. Elizabeth’s Medical Center

02:00pm | Cath Lab Pharmacology

Mirembe Reed, Pharm.D, St. Elizabeth’s Medical Center

Register now »

SOURCE

From: <acvp@getresponse.com> on behalf of “Kurt, ACVP” <kurt@acp-online.org>

Reply-To: <kurt@acp-online.org>

Date: Monday, April 24, 2017 at 2:26 PM

To: Aviva Lev-Ari <AvivaLev-Ari@alum.berkeley.edu>

Subject: cardiovascular symposium in Boston, May 20

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First U.S. TAVR Patients Treated With Temporary Pacing Lead (Tempo Lead)

Posted in Aortic Valve: TAVR, TAVI vs Open Heart Surgery, Cardiac and Cardiovascular Surgical Procedures, Electrophysiology, Frontiers in Cardiology and Cardiovascular Disorders, Medical Devices R&D and Inventions, Valves & Tools on December 21, 2016| Leave a Comment »

First U.S. TAVR Patients Treated With Temporary Pacing Lead (Tempo Lead)

Reporter: Aviva Lev-Ari, PhD, RN

 

UPDATED on 8/2/2017

Medtronic wins FDA nod, CE Mark for Avalus aortic valve

AUGUST 2, 2017 BY FINK DENSFORD

http://www.massdevice.com/medtronic-wins-fda-nod-ce-mark-avalus-aortic-valve/?utm_source=newsletter-170802&utm_medium=email&utm_campaign=newsletter-170802&spMailingID=11611945&spUserID=MTU0MTAzNDg3OTA5S0&spJobID=1220180538&spReportId=MTIyMDE4MDUzOAS2

 

 

BioTrace Medical, Inc., a venture backed company based in San Carlos, Calif., is dedicated to reinventing temporary pacing to improve patient outcomes and reduce hospital costs.

For more information: www.biotracemedical.com

 

FDA Clears Temporary Pacing Technology for Transcatheter Aortic Valve and EP Procedures

The BioTrace Medical Tempo temporary pacing lead is designed to reduce complications and hospital length of stay

The Tempo Lead represents the first major advance in temporary pacing since the technology was introduced decades ago,” said Susheel Kodali, M.D., director of the Heart Valve Program at the Center for Interventional Vascular Therapy at Columbia University Medical Center in New York. “As a critical component of every TAVR procedure, temporary leads are integral to successful clinical outcomes for patients. I am excited about the potential of this technology and look forward to using it in my practice.”

Results of the first-in-human study of the technology will be presented at the annual Transcatheter Cardiac Therapeutics (TCT) conference in Washington, D.C. on Sunday, Oct. 30, at 10:59 a.m. eastern time in Room 209, Level 2.

“FDA clearance is an exciting milestone for BioTrace,” said Laura Dietch, CEO of BioTrace Medical. “We are pleased to bring this important innovation to the significant and growing number of patients needing better temporary pacing options to minimize risks and life-threatening complications. We look forward to launching in select U.S. centers in the coming weeks.”

For more information: www.biotracemedical.com

SOURCE

http://www.dicardiology.com/product/fda-clears-temporary-pacing-technology-transcatheter-aortic-valve-and-ep-procedures

December 19, 2016 — BioTrace Medical Inc. announced the first commercial use of the company’s Tempo Temporary Pacing Lead since U.S. Food and Drug Administration (FDA) 510(k) clearance in October.

The first cases involved patients undergoing transcatheter aortic valve replacement (TAVR) procedures and were performed by James Harkness, M.D., interventional cardiologist, and Brian K. Whisenant, M.D., medical director of the Structural Heart Disease Program at Intermountain Medical Center in Salt Lake City, Utah, and Susheel Kodali, M.D., director of the Heart Valve Program at Columbia University Medical Center/New York Presbyterian Hospital.

BioTrace Medical’s Tempo Lead is for use in procedures in which

  • Temporary pacing is indicated, including
  • TAVR and
  • Electrophysiology (EP) procedures.

The lead is designed for secure and stable cardiac pacing with the goal of reducing complications and allowing patients to ambulate sooner after procedures.

“The Tempo Lead is designed to alleviate the risks associated with lead dislodgement and inconsistent pacing, providing a safer option for patients.”

Temporary leads are used in more than 350,000 procedures each year, a number that is growing rapidly as the population ages and TAVR becomes increasingly common. The temporary pacing lead, a small catheter with two electrodes, is placed in the right ventricle of the heart through a vein in the groin or neck. The lead is then connected to an external pacemaker allowing a physician to monitor and control a patient’s heart rate for several days.

SOURCE

http://www.dicardiology.com/content/first-us-tavr-patients-treated-temporary-pacing-lead?eid=333021707&bid=1620839

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Advances and Future Directions for Transcatheter Valves Mitral and tricuspid valve repair technologies now in development

Posted in Aortic Valve: TAVR, TAVI vs Open Heart Surgery, Cardiac and Cardiovascular Surgical Procedures, Frontiers in Cardiology and Cardiovascular Disorders, Mitral Valve: Repair and Replacement, Origins of Cardiovascular Disease, Tricuspid Valve Repair, Valves & Tools on December 6, 2016| Leave a Comment »

Advances and Future Directions for Transcatheter Valves – Mitral and tricuspid valve repair technologies now in development

Reporter: Aviva Lev-Ari, PhD, RN

 

Based on

http://www.dicardiology.com/article/advances-and-future-directions-transcatheter-valves

 

Read the article “First TAVR Device Receives European Approval to Treat Intermediate Risk Patients”from August 2016.

Watch the video “The Evolution of TAVR Technology.” Interview with Juan Granada, M.D., executive director and chief scientific officer of the Cardiovascular Research Foundation’s Skirball Center for Innovation, at the Transcatheter Valve Therapies 2015 meeting.

 

Watch the video “TAVR Beats Surgery — Top News From ACC.16.” Dr. Vinod Thourani, professor of surgery, Division of Cardiothoracic Surgery, Department of Surgery, Emory University School of Medicine and a co-investigator for the PARTNER II Trial, discusses the biggest news item from ACC.16 — the Sapien 3 TAVR device performed better that surgical aortic valve replacement.

Watch the video “CoreValve Trumps Surgical Valve Replacement — TVT 2015.” Interview with Michael Reardon, M.D., professor of cardiothoracic surgery at DeBakey Heart and Vascular Center, and chairman of the patient screening committee, CoreValve U.S. pivotal trial, at the Transcatheter Valve Therapies 2015 meeting.

 

Read the article “FDA Clears Sapien XT for Valve-In-Valve Procedures.”

Read the article “FDA Expands Use of CoreValve for Aortic Valve-in-Valve Replacement.”

Transcatheter Mitral Valves are the Next Frontier

Most interventional and cardiac surgical experts say TMVR will be the next frontier in minimally invasive structural heart interventions. With the success and rapid growth of TAVR, there is an immense anticipation that TMVR will have an even greater impact in cardiology. This has translated into more than $2.5 billion being spent in the past year by vendors purchasing start-up TMVR companies, while less than 50 patients have actually been treated using these technologies, said Michael Mack, M.D., medical director, cardiovascular surgery, Baylor Health Care System and chairman of The Heart Hospital Baylor Plano Research Center.

However, the mitral valve involves much more complex anatomy than the aortic valve, so the devices, imaging for procedural planning and guidance will be much more sophisticated than what is used for TAVR. Among the challenges are: fixation of a device to the very small landing zone of the mitral annulus; avoiding the left ventricular outflow tract (LVOT); avoiding compression of the atrioventricular (AV) node; avoiding the papillary muscle and chordae tendineae; ensuring the device seals properly to avoid paravalvular regurgitation; and the device needs to be able to adapt to remodeling of the anatomy. There are more than 20 TMVR devices in development. The majority of these valves utilize a self-expanding nitinol frame that engages both sides of the native mitral valve annulus for fixation, similar to Amplatzer septal closure devices.

The companies with first-in-human TMVR implants include Tendyne, Neovasc and Edwards Lifesciences’ Fortis and Sapien XT devices. The Neovasc Tiara, Tendyne Bioprosthetic Mitral Valve and CardiAQ Valve Technologies TMVR system all have been granted FDA conditional investigational device exemption (IDE) studies.

Watch the video “Transcatheter Mitral Valve Therapies in Development.” 

Watch the video “Transcatheter Mitral Valve Repair Technologies.” An interview with Ted Feldman, M.D., FACC, MSCAI, FESC, cardiac cath lab director, Evanston Hospital, North Shore Health System, and principle investigator, Everest II MitraClip U.S. pivotal trial, at the Transcatheter Valve Therapies 2015 meeting.

 

Advancements in TAVR and TMVR Technologies at TCT 2016 

Watch the video VIDEO “Transcatheter Valve Technology Advancements at TCT 2016.” This is an interview Torsten Vahl, M.D., about advancements in transcatheter valve repair technology, including new devices for the aortic, mitral and tricuspid valves. Vahl is director of experimental and translational research and assistant professor of medicine, Columbia University Medical Center, Center for Interventional Vascular Therapy.

Watch the video “VIDEO: Transcatheter Mitral Valve Technology, Anatomical Challenges.” A discussion with Juan Granada, M.D., about transcatheter mitral valve advancements and device challenges at the Transcatheter Cardiovascular Therapeutics (TCT) 2016 annual meeting. Granada is executive director and chief scientific officer of the Cardiovascular Research Foundation’s Skirball Center for Innovation.

SOURCE

FEATURE | HEART VALVE TECHNOLOGY | NOVEMBER 12, 2015| DAVE FORNELL

Advances and Future Directions for Transcatheter Valves – Mitral and tricuspid valve repair technologies now in development

http://www.dicardiology.com/article/advances-and-future-directions-transcatheter-valves

 

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

 

Mitral Valve Repair: Who is a Patient Candidate for a Non-Ablative Fully Non-Invasive Procedure?

Justin Pearlman, MD, PhD, FACC and Aviva Lev-Ari, PhD, RN

Mitral Valve Repair: Who is a Patient Candidate for a Non-Ablative Fully Non-Invasive Procedure?

 

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Hadassah Opens Israel’s First Heart Valve Disease Clinic

Posted in Aortic Valve: TAVR, TAVI vs Open Heart Surgery, Cardiac and Cardiovascular Surgical Procedures, Mitral Valve: Repair and Replacement, PCI, Tricuspid Valve Repair on December 6, 2016| Leave a Comment »

Hadassah Opens Israel’s First Heart Valve Disease Clinic

Reporter: Aviva Lev-Ari, PhD, RN

 

WEDNESDAY, NOV 30 2016

“Until recently, the default treatment for valve disease has been open heart surgery to replace the damaged valve or valves.”

The Hadassah Medical Organization has opened Israel’s first Heart Valve Disease Clinic, which is geared toward detecting and treating the most complicated cases of heart valve disease–a growing problem in an aging population.

Until recently, the default treatment for valve disease has been open heart surgery to replace the damaged valve or valves. Currently, these invasive procedures are often superseded by less invasive cardiac catheterizations. In any case, however, efficiently treating valve disease and minimizing life-threatening risk factors such as heart attack remains an ongoing struggle for cardiovascular specialists.

As Prof. Ronen Beeri, head of Hadassah’s Cardiovascular Research Center, explains: “A ‘cardio team’ is needed to treat a patient suffering from heart valve disease. The time from referral to our Heart Institute to receive treatment from the relevant specialist can sometimes take months. Generally, patients with complex issues cannot afford to wait that long. The multidisciplinary cardio team solution at our new Clinic will help streamline the process so that a patient will receive all the necessary echocardiograms and other exams needed to diagnose and begin treatment within a week’s time.”

SOURCE

http://www.hadassah.org/news-stories/heart-valve-disease.html

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New method for performing Aortic Valve Replacement: Transmural catheter procedure developed at NIH, Minimally-invasive tissue-crossing – Transcaval access, abdominal aorta and the inferior vena cava

Posted in Abdominal Aorta, Aortic Valve: TAVR, TAVI vs Open Heart Surgery, Cardiac and Cardiovascular Surgical Procedures on October 31, 2016| Leave a Comment »

New method for performing Aortic Valve Replacement: Transmural catheter procedure developed at NIH, Minimally-invasive tissue-crossing – Transcaval access, abdominal aorta and the inferior vena cava

 

Reporter: Aviva Lev-Ari, PhD, RN

 

VIEW VIDEO

 

The new method was developed by researchers at the National, Heart, Lung and Blood Institute (NHLBI) and tested in a trial on 100 patients at 20 hospitals across the United States. Researchers said it proved successful in 99 of the patients.

“This is a seminal study,” said the lead author, cardiologist Adam B. Greenbaum, M.D., co-director of the Henry Ford Hospital Center for Structural Heart Disease, Detroit. “It challenged conventional wisdom, which objected to the idea of safe passage between the vena cava and the aorta. More important, it is the first of many non-surgical minimally-invasive tissue-crossing, or so-called transmural catheter procedures developed at NIH that can be applied to diverse fields of medicine.”

Robert J. Lederman, M.D., a senior investigator in NHLBI’s Division of Intramural Research who led the study, said researchers developed the method to address a specific clinical need, even though they knew it would be a challenging proposition for most surgeons and physicians to accept. The proposed and counterintuitive mechanism of action is that bleeding from the aorta spontaneously decompresses into a corresponding hole the physician makes in the vein, because the surrounding area behind the peritoneum has higher pressure than the vein.

The results of the research, which were independently confirmed by a committee of outside cardiologists, show the procedure not only has a high success rate, but also an acceptable rate of bleeding and vascular complications, particularly in the high risk patients studied. The study builds on the access technique that Lederman’s NHLBI team developed and first tested in animals in 2012 and first applied with Henry Ford physicians to help patients in 2013. NHLBI and its collaborators are now working to find ways to train more specialists to perform the procedure.

The study will also be presented on Monday, October 31 at the Transcatheter Cardiovascular Therapeutics conference in Washington, D.C. Co-authors include researchers from

  • Henry Ford Hospital;
  • Emory University, Atlanta;
  • Oklahoma Heart Institute, Tulsa;
  • Lexington Medical Center, West Columbia, South Carolina; and
  • Oschner Medical Center, New Orleans.

Researchers at the National Institutes of Health have developed a new, less invasive way to perform transcatheter aortic valve replacement (TAVR), a procedure widely used to treat aortic valve stenosis, a lethal heart condition. The new approach, called transcaval access, will make TAVR more available to high risk patients, especially women, whose femoral arteries are too small or diseased to withstand the standard procedure. The Journal of the American College of Cardiology published the findings.

Aortic valve stenosis involves the narrowing of the heart’s aortic valve which reduces blood flow through the heart. For about 85 percent of patients with this condition, doctors typically perform TAVR through the femoral artery in the leg. But for the other 15 percent, doctors must find a different access route. The most common alternative routes are through the chest, which requires surgery and are associated with significantly more complications.

Transcaval access, which can be performed in awake patients, involves electrifying a small wire so that it crosses between neighboring blood vessels in the abdomen. The technique calls for making large holes in both the abdominal aorta and the inferior vena cava, which physicians previously considered dangerous because of the risk of fatal bleeding.

SOURCE

https://www.nih.gov/news-events/news-releases/new-method-performing-aortic-valve-replacement-proves-successful-high-risk-patients

http://www.medscape.com/viewarticle/871196?nlid=110314_3866&src=WNL_mdplsfeat_161101_mscpedit_card&uac=93761AJ&spon=2&impID=1226378&faf=1

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Robot-assisted coronary intervention program @MGH – The first CorPath Vascular Robotic System, lets Interventional Cardiologists position the right stent in the right place at reduces radiation exposure by 95%

Posted in Aortic Valve: TAVR, TAVI vs Open Heart Surgery, Cardiac and Cardiovascular Surgical Procedures, PCI, Peripheral Arterial Disease & Peripheral Vascular Surgery, tagged on October 17, 2016| Leave a Comment »

Robot-assisted coronary intervention program @MGH – The first CorPath Vascular Robotic System, lets Interventional Cardiologists position the right stent in the right place at reduces radiation exposure by 95%

Reporter: Aviva Lev-Ari, PhD, RN

 

Robot in the cath lab takes surgeons out of radiation’s way

October 3, 2016 By Abigail Esposito Leave a Comment

The system consists of a bedside unit and an interventional cockpit. Developer Corindus Vascular Robotics says the radiation-shielded cockpit features a control console with simple-to-use controls for the precise positioning of guidewires, balloons and stent catheters.

An interventional cardiologist loads the single use cassette and later manually introduces the guiding catheter into the coronaries. At that time, the physician can remove their lead covers and sit behind the Interventional Cockpit to perform the remainder of their procedure.

Harmful Exposures in the Cath Lab:

  • One study of self-reported brain tumors in interventionists showed that 86% of the tumors were left-brain—the side of the head most often exposed to radiation during procedures.
  • There’s also the risk of orthopedic injuries from wearing the heavy, leaded equipment used to block radiation (interventionists practicing over 21 years suffer a 60% incidence of spine issues) and
  • Cataracts, another effect of radiation exposure in interventionists. In a RELID study (Retrospective Evaluation of Lens Injuries and Dose), 50% of interventional cardiologists had posterior subcapsular lens changes (precursors to cataracts) caused by radiation exposure, versus less than 10% in the control group.

Benefits of CorPath Vascular Robotic System

One trial (Percutaneous Robotically-Enhanced Coronary Intervention Study) showed a

  • 95.2% reduction in radiation exposure for the primary operator,
  • 98.8% device success and
  • 97.6% clinical success with no device-related complications. What’s more, the trial saw a
  • 9% reduction in stent use as compared to historical data.

http://www.medicaldesignandoutsourcing.com/robot-in-the-cath-lab-takes-surgeons-out-of-radiations-way/?spMailingID=9704333&spUserID=MTU0MTAzNDg3OTA5S0&spJobID=1021334606&spReportId=MTAyMTMzNDYwNgS2

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Second in the United States to implant Edwards Newly FDA-Approved Aortic Valve “Intuity Elite” Sutureless Valve at Northwestern Medicine

Posted in Aortic Valve: TAVR, TAVI vs Open Heart Surgery, Cardiac and Cardiovascular Surgical Procedures on October 13, 2016| Leave a Comment »

Second in the United States to implant Edwards Newly FDA-Approved  Aortic Valve “Intuity Elite” Sutureless Valve at Northwestern Medicine

Reporter: Aviva Lev-Ari, PhD, RN

Northwestern Medicine First in Illinois to Implant New FDA-Approved Aortic Valve

Second in the United States to implant Edwards Intuity Elite valve with newly designed deployment system

Northwestern Medicine, Edwards Lifesciences, Intuity Elite suturless aortic valve, first in Illinois

Edwards Intuity valve image courtesy of Northwestern Medicine

October 7, 2016 — A Northwestern Medicine cardiac surgeon was recently the first in Illinois and second in the United States to implant the Edwards Intuity Elite sutureless aortic valve in a patient with coronary artery disease. The device was implanted through the newly U.S. Food and Drug Administration (FDA)-approved, minimally invasive delivery system.

Patrick McCarthy, M.D., executive director of Northwestern Medicine Bluhm Cardiovascular Institute and chief of cardiac surgery at Northwestern Memorial Hospital, led the team that implanted the aortic valve in Robert Kurinsky, a 74-year-old retiree from Oak Brook, Ill. Kurinsky had been treating his slowly deteriorating heart valve since 2012 primarily through medication.

“Using this newly approved valve system helped replace Mr. Kurinsky’s valve in only 12 minutes, which means less trauma to the body and a quicker recovery time,” said McCarthy, who is also the Heller-Sacks Professor of Medicine at Northwestern University Feinberg School of Medicine. “The valve opening is slightly larger than a standard valve, a positive feature for heart function in the coming years. We are always looking to find the safest and most effective means of treating our patients, and I was pleased we could offer this option to Mr. Kurinsky days after the FDA approved it.”

Traditionally, open-heart surgery is the preferred method for valve replacement but increasingly cardiologists and cardiac surgeons are turning to minimally invasive approaches, a critical sea change in the field of cardiac care. McCarthy led the clinical trial at Northwestern Medicine Feinberg School of Medicine for the new valve prior to its approval by the FDA.

The FDA approved, in August 2016, the advanced Edwards Intuity Elite valve system, a deployment device that incorporates some elements of transcatheter aortic valve replacement (TAVR), a minimally invasive valve replacement system.

Kurinsky said he was thrilled to learn of a less invasive option to replace his aortic valve just days before his scheduled surgery. His wife Carol Kurinsky said she could not believe when he picked up the phone in the intensive care unit and said hello the morning after the surgery. She had left him late the night before and he was on a breathing tube.

“I was told my aortic valve was closing, and we came to Northwestern for a second opinion,” said Kurinsky, who works part-time as a golf starter and is an avid international traveler, two avocations he plans to return to soon. “Coming to Northwestern and Dr. McCarthy was the best decision we made.”

For more information: www.edwards.com

SOURCE

http://www.dicardiology.com/content/northwestern-medicine-first-illinois-implant-new-fda-approved-aortic-valve?eid=333021707&bid=1554809

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Chest Radiation Therapy causes Collateral Damage to the Human Heart

Posted in Aortic Valve: TAVR, TAVI vs Open Heart Surgery, Cancer Surgery of the Heart, Cardiac and Cardiovascular Surgical Procedures on August 28, 2016| Leave a Comment »

Chest Radiation Therapy causes Collateral Damage to the Human Heart

Reporter: Aviva Lev-Ari, PhD, RN

“Radiation therapy for some forms of cancer involves a large dose of radiation to the chest,” says Milind Desai, MD, Director of Cardiovascular Imaging Research at Cleveland Clinic. “The heart can suffer collateral damage as a result.”

Guideposts for identification

The key to identifying true radiation-associated heart disease, says Dr. Desai, is later injury — whether constrictive pericarditis, coronary artery disease, valvular disease or conduction abnormalities. He adds that the prevalence of radiation-associated heart disease is difficult to ascertain, due in part to its considerable latency, although it appears to be increasing.

Risk factors for radiation-associated heart disease include:

  • Total radiation dose > 20-35 Gy
  • Doses > 2 Gy/day
  • Increased volume of heart irradiated
  • Younger age
  • Time since exposure
  • Concomitant cardiotoxic chemotherapy
  • Other cardiovascular risk factors (diabetes mellitus, smoking)
  • Radiation source (cobalt)

SOURCE

https://consultqd.clevelandclinic.org/2016/02/radiation-heart-disease-learnings-diverse-daunting-entity/?utm_campaign=qd+tweets&utm_medium=social&utm_source=twitter&utm_content=160223+radiation+heart+disease+learnings&dynid=twitter-_-qd+tweets-_-social-_-social-_-160223+radiation+heart+disease+learnings

Heart Surgery to a Damaged Heart by Radiation

Patients undergoing cardiothoracic surgery at Cleveland Clinic over a three-year period had a 2.5-fold elevated mortality risk if they had a history of malignancy requiring chest irradiation compared with matched controls who underwent the same surgery but did not have a history of malignancy or chest irradiation. Most of the patients with the cancer history had had either

  • Breast cancer (53 percent) or
  • Hodgkin lymphoma (27 percent).
Long-Term Survival of Patients With Radiation Heart Disease Undergoing Cardiac Surgery

A Cohort Study

Willis Wu, Ahmad Masri, Zoran B. Popovic, Nicholas G. Smedira, Bruce W. Lytle, Thomas H. Marwick, Brian P. Griffin and Milind Y. Desai
http://dx.doi.org/10.1161/CIRCULATIONAHA.113.001435
Published: April 9, 2013

Alternative treatment approaches, including transcatheter aortic valve replacement or other percutaneous interventions, may be more appropriate after identifying risk.

 

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

Cardio-oncology and Onco-Cardiology Programs: Treatments for Cancer Patients with a History of Cardiovascular Disease

Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2014/01/08/cardio-oncology-and-onco-cardiology-programs-treatments-for-cancer-patients-with-a-history-of-cardiovascular-disease/

 

Series A: e-Books on Cardiovascular Diseases

Series A Content Consultant: Justin D Pearlman, MD, PhD, FACC

VOLUME THREE

Etiologies of Cardiovascular Diseases:

Epigenetics, Genetics and Genomics

http://www.amazon.com/dp/B018PNHJ84

by  

Larry H Bernstein, MD, FCAP, Senior Editor, Author and Curator

and

Aviva Lev-Ari, PhD, RN, Editor and Curator

https://pharmaceuticalintelligence.com/biomed-e-books/series-a-e-books-on-cardiovascular-diseases/volume-three-etiologies-of-cardiovascular-diseases-epigenetics-genetics-genomics/

 

  • Cardiovascular Diseases, Volume Three: Etiologies of Cardiovascular Diseases: Epigenetics, Genetics and Genomics, on Amazon since 11/29/2015

http://www.amazon.com/dp/B018PNHJ84

onepagecvdseriesaflyervol1-4

 

 

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The presence of any Valvular Heart Disease (VHD) did not influence the comparison of Dabigatran [Pradaxa, Boehringer Ingelheim] with Warfarin

Posted in Aortic Valve: TAVR, TAVI vs Open Heart Surgery, Atherogenic Processes & Pathology, Atrial Fibrilation (a-Fib), Cardiac Pacing and Arrhythmias, Cardiac and Cardiovascular Surgical Procedures, Coagulation Therapy and Internal Bleeding, Electrophysiology, Frontiers in Cardiology and Cardiovascular Disorders, Mitral Valve: Repair and Replacement, Origins of Cardiovascular Disease, Regulated Clinical Trials: Design, Methods, Components and IRB related issues, Valves & Tools, tagged , , , , , on August 16, 2016| Leave a Comment »

The presence of any Valvular Heart Disease (VHD) did not influence the comparison of Dabigatran [Pradaxa, Boehringer Ingelheim] with Warfarin

Reporter: Aviva Lev-Ari, PhD, RN

 

UPDATED on 10/22/2018

Dabigatran (Pradaxa) was no better than aspirin for prevention of recurrent stroke among patients with an embolic stroke of undetermined source in the RE-SPECT ESUS trial reported at the World Stroke Congress.

 

Pradaxa® (dabigatran etexilate)
Clinical experience of Pradaxa® equates to over 9 million patient-years in all licensed indications worldwide. Pradaxa® has been in the market for more than ten years and is approved in over 100 countries.15
Currently approved indications for Pradaxa® are:16,17
  • Prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation and a risk factor for stroke
  • Primary prevention of venous thromboembolic events in patients undergoing elective total hip replacement surgery or total knee replacement surgery
  • Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and the prevention of recurrent DVT and recurrent PE in adults
Dabigatran, a direct thrombin inhibitor (DTI), was the first widely approved drug in a new generation of direct oral anticoagulants, available to target a high unmet medical need in the prevention and treatment of acute and chronic thromboembolic diseases.18,19,20
REFERENCES

16 Pradaxa® US Prescribing Information, 2018.
17 Pradaxa® European Summary of Product Characteristics, 2018.
18 Stangier J. Clinical pharmacokinetics and pharmacodynamics of the oral direct thrombin inhibitor dabigatran etexilate. Clin Pharmacokinet. 2008;47(5):285–95.
19 Di Nisio M. et al. Direct thrombin inhibitors. N Engl J Med.2005;353:1028–40.
20 Stangier J. et al. Pharmacokinetic Profile of the Oral Direct Thrombin Inhibitor Dabigatran Etexilate in Healthy Volunteers and Patients Undergoing Total Hip Replacement. J Clin Pharmacol. 2005;45:555–63

SOURCE

https://www.boehringer-ingelheim.com/press-release/Results-from-two-Pradaxa-trials-to-be-presented-at-WSC

 

 

Event Rate and Outcome Risk, With vs Without Valvular Heart Disease

Outcome Valvular heart disease, event rate/y, % No valvular heart disease, event rate/y, % HR (95% CI)* P
Stroke, systemic embolic event 1.61 1.41 1.09 (0.88–1.33) 0.43
Major bleeding 4.36 2.84 1.32 (1.16–1.33) <0.001
Intracranial hemorrhage 0.51 0.41 1.20 (0.83–1.74) 0.32
All-cause mortality 4.45 3.67 1.09 (0.96–1.23) 0.18
*Adjusted using propensity scores

ORIGINAL RESEARCH ARTICLE

Comparison of Dabigatran versus Warfarin in Patients with Atrial Fibrillation and Valvular Heart Disease: The RE-LY Trial

Michael D. Ezekowitz, Rangadham Nagarakanti, Herbert Noack, Martina Brueckmann, Claire Litherland, Mark Jacobs, Andreas Clemens,Paul A. Reilly, Stuart J. Connolly, Salim Yusuf and Lars Wallentin

 http://dx.doi.org/10.1161/CIRCULATIONAHA.115.020950

 

Results—There were 3950 patients with any VHD:

  • 3101 had mitral regurgitation,
  • 1179 tricuspid regurgitation,
  • 817 aortic regurgitations,
  • 471 aortic stenosis and
  • 193 mild mitral stenosis.

At baseline patients with any VHD had more

  • heart failure,
  • coronary disease,
  • renal impairment and
  • persistent atrial fibrillation.

Patients with any VHD had higher rates of

  • major bleeds (HR 1.32; 95% CI 1.16-1.5)

but similar

  • stroke or systemic embolism (SEE) rates (HR 1.09; 95% CI 0.88-1.33).

For D110 patients, major bleed rates were lower than warfarin (HR 0.73; 95% CI 0.56-0.95 with and HR 0.84; 95% CI 0.71-0.99 without VHD) and

For D150 similar to warfarin in patients with (HR 0.82; 95% CI 0.64-1.06) or without VHD (HR 0.98; 95% CI 0.83-1.15).

For D150 patients stroke/SEE rates were lower versus warfarin with (HR 0.59; 95% CI 0.37-0.93) and without VHD (HR 0.67; 95% CI 0.52-0.86) and similar to warfarin for D110 irrespective of presence of VHD (HR 0.97 CI 0.65-1.45 and 0.85 CI 0.70-1.10).

For intracranial bleeds and death rates for D150 and D110 were lower vs warfarin independent of presence of VHD.

Conclusions—The presence of any VHD did not influence the comparison of dabigatran with warfarin.

Clinical Trial Registration—URL: http://clinicaltrials.gov. Unique Identifier: NCT00262600.

SOURCES

http://circ.ahajournals.org/content/early/2016/08/05/CIRCULATIONAHA.115.020950

http://www.medscape.com/viewarticle/867482?nlid=108872_3866&src=WNL_mdplsfeat_160816_mscpedit_card&uac=93761AJ&spon=2&impID=1179558&faf=1

 

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