Feature | November 21, 2013

Study Confirms TAVR is Safe, Effective for Aortic Valve Replacement in Select Patients

STS/ACC TVT Registry provides important post-approval study data

November 21, 2013 — Data from a national registry developed to track patient safety and real-world outcomes finds that the initial use of transcatheter aortic valve replacement (TAVR) for treatment of aortic stenosis in high surgical risk and inoperable patients in the United States is safe and effective. The data, published as a study in the Nov. 20 issue of the Journal of the American Medical Association (JAMA), confirms results of premarket clinical trials and represents the first public report from the STS/ACC (Society of Thoracic Surgeons/American College of Cardiology) Transcatheter Valve Therapy (TVT) registry.

“The large volume of data in the registry provided an excellent source to promptly examine patient characteristics and outcomes,” said Michael Mack, M.D., Heart Hospital Baylor Plano, Baylor Healthcare System, Plano, Texas, and chair of the STS/ACC TVT Registry Steering Committee and lead author.

The STS/ACC TVT registry was launched December 2011, shortly after U.S. Food and Drug Administration (FDA) approval of the Edwards Lifesciences Sapien transcatheter heart valve. In May 2012, the Centers for Medicare & Medicaid Services (CMS) required all hospitals performing TAVR to capture clinical information in the STS/ACC TVT Registry as a requirement for Medicare coverage. CMS uses hospital data to facilitate outcomes assessment, as well as comparison with other trials and international registries. Building the STS/ACC TVT registry was a joint effort of STS, ACC, FDA, CMS, the National Institutes of Health and Duke Clinical Research Institute. It represents the first time that such a broad collaborative group has supported the safe introduction and rational dispersion of new medical devices in the United States.

“The TVT registry is the result of two transformational events: The first is based on the approval and now widespread use of TAVR technology in the United States and around the world, and the second is the coming together of professional societies and U.S. regulatory agencies to optimize outcomes of patients with severe valvular heart disease,” said David Holmes, M.D., former president of the ACC.  “These events promise to be increasingly important vehicles to help ensure that U.S. patients have efficient access to safe and effective new strategies of care. This first manuscript is the initial delivery of what these transformational events can accomplish.”

The analysis included 7,710 patients who underwent TAVR at one of 224 of the sites participating in the TVT registry. Among patients included in the analysis, device implantation was successfully achieved in 92 percent of operations. The overall in-hospital mortality rate was 5.5 percent and the stroke rate was 2 percent.

“Given the low in-hospital mortality and stroke rates, our real-world results from this newly introduced technology are similar to the success rates and complication patterns documented in carefully performed randomized trials that resulted in FDA approval,” said Mack. “The results are also similar to the global experience of TAVR, which is now based on second- and third-generation devices. We think that the American public can feel comfortable that this new registry is an effective means of monitoring the performance of new medical devices after they have been approved. ”

Mack cautioned, however, that longer term follow-up is essential to assess continued safety, efficacy and patient health status.

Future of the TVT Registry 

The TVT registry currently has more than 10,000 patient records and enrollment is on track to double that number in the next year. The large number of patient records allows for the development of reliable benchmarks for centers to compare their local results against risk-adjusted national standards. Ultimately this will translate into improved patient selection and optimal patient care.

“We envision the TVT registry as an evolving portfolio of transcatheter heart valve device modules as part of the FDA’s new strategic plan for post-market device surveillance,” said Fred Edwards, M.D. director, STS Research Center and study author. “As new medical devices are approved in the United States, we intend to incorporate experience with these devices into the registry. This should provide a streamlined approach to national device surveillance and open up new avenues into research focused on the risks and benefits of medical device products.”

For more information: www.tvtregistry, jama.jamanetwork.com, www.sts.org, cardiosource.org

Related Content

ICDs, non-ischemic cardiomyopathy, University of Alabama at Birmingham study, Circulation
News | Implantable Cardioverter Defibrillators (ICD)| January 18, 2017
A new study published in Circulation has found there is a 23 percent risk in reduction of all-cause mortality in non-...
TAVR, medical guidelines, ACC/AHA, optimization, transcatheter aortic valve replacement
News | Heart Valve Technology| January 18, 2017
The American College of Cardiology recently released new guidance for clinicians and hospitals to use in assessing...
stress, brain activity, cardiovascular risk, PET-CT, MGH, ISSMS, The Lancet study
News | Cardiac Diagnostics| January 18, 2017
A study led by Massachusetts General Hospital (MGH) and Icahn School of Medicine at Mount Sinai (ISSMS) investigators...
Medtronic, CoreValve Evolut R 34 mm valve, TAVI, CE Mark, European launch
News | Heart Valve Technology| January 17, 2017
Medtronic plc announced the CE (Conformité Européenne) mark and European launch of the CoreValve Evolut R 34 mm valve...
ICDs, implantable cardioverter defibrillators, survival rate, elderly patients, JACC study
News | Implantable Cardioverter Defibrillators (ICD)| January 17, 2017
Of patients over age 65 who received an implantable cardioverter-defibrillator (ICD) after surviving sudden cardiac...
University of Utah, Frank Sachse, heart failure, LVAD implantation, left ventricular assist device, biomarker, t-system

Two patients may seem equally sick based upon clinical measures, but differences in their heart physiology could predict who has the potential to recover from heart failure. A study carried out by scientists at the University of Utah finds that patients whose hearts have flattened t-tubules have a decreased chance of showing signs of recovery after implanting a mechanical heart pump. Ordinarily, t-tubules in the heart are long, thin, and rounded. Image courtesy of Frank Sachse.

News | Cardiac Diagnostics| January 17, 2017
Investigators at the University of Utah have identified distinct differences in the hearts of advanced heart failure...
Synergy stent, abluminal polymer DES, bioresorbable polymer DES, bioresorbable polymer metallic stent

The Synergy stent is the first FDA cleared drug-eluting stent to use a bioresorbable polymer drug carrier. When the polymer dissolves after about four months, the devices become a bare metal stent. The technology is supposed to reduce the rate of late stent thrombosis due to vessel inflammation caused by durable polymers.

Feature | Stents Bioresorbable| January 17, 2017 | Dave Fornell
One of the big advancements in drug-eluting stent (DES) technology has been the development of bioresorbable polymers
St. Jude Medical, Amplatzer Amulet LAA Occluder, observational study, TCT 2016
News | Left Atrial Appendage (LAA) Occluders| November 03, 2016
St. Jude Medical Inc. presented favorable results from the largest observational study to date of the company’s...
Medtronic, CoreValve Evolut R TAVR system, U.S. IDE Study, TCT 2016
News | Heart Valve Technology| November 03, 2016
Medtronic plc unveiled new clinical data showing that patients treated with the self-expanding CoreValve Evolut R...
congenital heart patients, cardiac cath lab, anesthesia sedation practices, joint document, SCAI, SPA, CCAS
News | Congenital Heart| November 03, 2016
The Society for Cardiovascular Angiography and Interventions (SCAI), the Society for Pediatric Anesthesia (SPA) and the...
Overlay Init