Funding, Deals & Partnerships: BIOLOGICS & MEDICAL DEVICES; BioMed e-Series; Medicine and Life Sciences Scientific Journal – http://PharmaceuticalIntelligence.com
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
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 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:
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
Treatment Strategies – CardiologyVolume 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 2will 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.
Clinical Trials on Transcatheter Aortic Valve Replacement (TAVR) to be conducted by American College of Cardiology and the Society of Thoracic Surgeons
Curator: Aviva Lev-Ari, PhD, RN
UPDATED on 6/22/2017
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.
SOURCE
1 in 10 TAVR Procedures Done Off-Label Despite early risks vs on-label use, ‘acceptable results’ cited from registry
Reviewed by Henry A. Solomon, MD, FACP, FACC Cinical Associate Professor, Weill Cornell Medical College and Dorothy Caputo, MA, BSN, RN, Nurse Planner
Second Generation Transcatheter Aortic Valve Shown to Successfully Address TAVR Complications
Results of the REPRISE II trial reported at TCT 2013
November 4, 2013
November 4, 2013 — In a clinical trial of the Boston Scientific Lotus valve, a second-generationtranscatheter aortic valve, the device demonstrated low rates of complications that are sometimes seen in transcatheter aortic valve replacement (TAVR), including challenges with positioning, post-procedure paravalvular aortic regurgitation, vascular complications and stroke.
The findings were presented at the 25th annual Transcatheter Cardiovascular Therapeutics scientific symposium (TCT 2013).
The valve studied in REPRISE II is fully retrievable and repositionable with an adaptive seal intended to minimize paravalvular regurgitation, a complication that has been associated with higher mortality among patients undergoing TAVR. In this prospective, single-arm, multicenter study, symptomatic patients at high risk for surgery received the Lotus valve to treat calcific aortic stenosis.
The trial enrolled 120 patients; mean age was 84.4±5.3 years, 56.7 percent were female and 75.8 percent were considered New York Heart Association (NYHA) Class III or IV. The mean Society of Thoracic Surgeons score was 7.1±4.6 percent and all patients were confirmed by their site heart team to be at high risk for surgery due to frailty or associated comorbidities.
The valve was successfully implanted in all 120 patients with valve repositioning and retrieval performed as needed. There was no embolization, ectopic valve deployment or need for implantation of a second prosthetic valve.
The primary device performance endpoint was the mean aortic valve pressure gradient at 30 days compared to a performance goal of 18 mmHg; the primary safety endpoint was 30-day mortality. The primary device performance endpoint was met with a 30 day mean aortic valve pressure gradient of 11.5±5.2 mmHg; mean effective orifice area was 1.7±0.4 cm2.
All cause mortality and disabling stroke were low at 30 days (4.2 percent and 1.7 percent, respectively). Additional clinical event rates were consistent with those reported for other valves. Aortic regurgitation at 30 days was negligible in 99 percent of patients (78.3 percent none, 5.2 percent trace and 15.5 percent mild). The total stroke rate, disabling and non-disabling, was 5.9 percent, which is the same as the rate as the Edward’s Sapien valve’s performance in the PARTNER trial.
“These findings suggest this valve, which is a differentiated, second generation TAVR device, will be a valuable addition for the treatment of severe aortic stenosis,” said Ian Meredith, MBBS, Ph.D., director, Monash HEART, executive director, Monash Cardiovascular Research Centre, professor of medicine, Monash University in Melbourne, Australia, and lead investigator of the study.
“This is the first time the societies have ever filed for an investigational device exemption,” former ACC president Ralph Brindis is quoted as saying. “The goal of the effort is to gain reimbursement for an expanded set of procedures with Sapien to make the device accessible to more patients.”
The new trials will mean that reimbursement will now be possible for some of these uses when patients are enrolled in the clinical trials. According to Mack, the NCD “took off-label use off the table. If you are a cynic this is good, but if you’re a practitioner this is tying your hands.”
According to Forbes, STS president Michael Mack told The Gray Sheet (a subscription-only publication) that the first trial will look at alternatives to transfemoral approaches in 1,000 patients who couldn’t otherwise have aortic valve surgery. There was a coordinated effort to develop a trial protocol, worked out between the CACC, STS, CMS, Edwards and the FDA. Expanded uses require an FDA label, he noted, and the only way to do that is to conduct a clinical trial with an IDE in hand.
So why would expanded TAVR uses be necessary? Well, the procedure has become very much in demand, and physicians already began pursuing off-label uses once they learned the initial TAVR procedure, Brindis told Forbes. The magazine notes that the entrance of both the STS and ACC into TAVR clinical trials greatly expands the TVT registry that they run, which tracks TAVR use in the United States to help physicians comply with Medicare’s National Coverage Decision for TAVR.
TAVR is indeed a hot space. St. Jude Medical ($STJ) won a CE mark for its Portico transcatheter heart valve late last fall, and Edwards’ Sapien competes with Medtronic‘s ($MDT) CoreValve in Europe. And smaller companies such as Micro Interventional Devices are working hard to develop surgical tools designed to enable TAVR procedures.
Brindis and Mack said that the ACC and STS worked closely with CMS,the FDA, and Edwards to develop the trial protocol. In the trial, patients not eligible for aortic valve surgery will receive TAVR through transapical and transaortic approaches and will be compared with the results of patients in the original PARTNER A trial who received TAVR through the transapical approach. Mack concedes that the trial design is not idea. “There is no perfect comparator,” he acknowledged.
Other experts in the field contacted by CardioBrief agreed that the challenges of trial design in this situation are quite formidable. Randomized trials are not always feasible and, in some situations, may be unethical. The IDE is an attempt to balance the need for rational clinical trials, on the one hand, and the growing pressure to perform off-label procedures. It should be noted that an important safeguard for patients remains in place: all potential TAVR patients will still need to be evaluated by both a cardiologist and a cardiac surgeon as part of the “heart team” approach mandated by the FDA and the NCD.
The ACC and STS are now working to gain FDA approval to perform two more studies. One would examine the role of alternative approaches in the high-risk population eligible for surgery. The second would study valve-in-valve TAVR procedures. Both studies also present challenging problems of trial design. Mack said he anticipates FDA approval of these protocols in the next few months.
Edwards agreed in principle to fund the clinical trials. An Edwards representative confirmed that the company planned to support these new trials, but the details have not yet been hammered out.
Mack states that the power and scope of the TVT registry actually makes it easier for ACC and STS to move forward than Edwards. Further, Mack believes that some indications are like “orphan” indications that are medically but not commercially compelling.
Politics and Transcatheter Aortic Valve Replacement
From the first early stages of its development, the prospect of transcatheter aortic valve replacement (TAVR) provoked two broad and competing fears:
Regulatory safeguards would kill a promising new technology, denying its life-saving benefits to many thousands of desperately sick people.
The stampede to stake a claim in a promising, highly lucrative new territory would lead to the exploitation and mistreatment of many thousands of desperately sick people.
Scott Gottlieb, a conservative activist who is a former FDA deputy commissioner and CMS adviser, concludes that the CMS ruling means “that for costly procedures, Washington will be making more of these choices for us.” In a posting on the American Enterprise Institute’s The Enterprise Blog, Gottlieb writes that the decision “is a vivid example of how our healthcare is going to get reimbursed now that Washington calls more of the shots.”
CMS has insisted that doctors who perform the procedure have adequate training and that the hospitals where the procedures are performed have sufficient experience and adequate facilities. Perhaps Scott Gottlieb, MD would be happy to send an elderly relative for TAVR to a local community hospital with little experience in the procedure. It was precisely to avoid this scenario that the American College of Cardiology and the Society of Thoracic Surgeons supported CMS in this coverage decision. I fail to see how anyone would benefit by widespread proliferation of TAVR by novice operators at inexperienced centers.
Physicians,
Regulators,
Insurers,
CMS,
Medical Device Manufactures
ACC, and
STS
will be cooperating in the College of Cardiology and Society of Thoracic Surgeons newly announced involvement in Clinical Trials on broader use of transcatheter aortic valve replacement (TAVR) procedure to include new patients that this procedure will be indicated for and CMS reimbursed.
Other aspects of the Procedure, and the role EdwardsSciences played in the development and the Industry Leadership it holds in the US, are covered in several articles on this Open Access Online Scientific Journal, including the following:
August 7, 2012 – Transcatheter Aortic Valve Implantation (TAVI): risk for stroke and suitability for surgery
6/19/2012Executive Compensation and Comparator Group Definition in the Cardiac and Vascular Medical Devices Sector: A Bright Future for Edwards Lifesciences Corporation in the Transcatheter Heart Valve Replacement Market
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