Feature | March 29, 2012

TAVI Study Shows Low Mortality, Improved Function at 30 Days

International multicenter ADVANCE study examines outcomes of TAVI at experienced centers

March 29, 2012 — Patients who underwent transcatheter aortic valve implantation (TAVI) at experienced medical centers had significant improvement in valve function as well as low mortality and stroke rates at 30 days, according to research presented this week at the American College of Cardiology (ACC) Annual Scientific Session.

The TAVI procedure includes inserting a bioprosthetic valve through a catheter and implanting it into a diseased native aortic valve. Because it is less invasive than surgical replacement, TAVI has been used for patients with a diseased aortic valve who cannot undergo surgery because of age, left ventricular dysfunction or the presence of coexisting conditions.

The ADVANCE study follows several trials already conducted to determine the safety and effectiveness of TAVI; however, it is the first large TAVI trial to use the Valve Academic Research Consortium’s (VARC) standards to define adverse events. It also used 44 centers that had each performed at least 40 TAVI procedures before joining the trial.

“This study evaluated real-world patients in everyday practice, allowing us to better understand the outcomes of typical use of TAVI,” said lead study author Axel Linke, professor of cardiology at the University of Leipzig Heart Center in Leipzig, Germany. “In addition, this study is one of the most rigorous TAVI studies ever conducted, and it is the first, large multicenter TAVI trial to report findings according to the new standard of evaluation, VARC.”

Between March 2010 and July 2011, a total of 1,015 high-risk patients with severe aortic stenosis were enrolled at 44 centers in 12 countries in Western Europe, Asia and South America. The patients’ mean age was 81 ± six years and 51 percent were female. The patients underwent TAVI and received the CoreValve System. They were then followed to determine the safety and efficacy of the procedure.

The study’s primary endpoint was the occurrence of major adverse cardiac and cerebrovascular events (MACCE), which is a composite of total death, stroke, heart attack and emergent cardiac surgery or percutaneous reintervention. The efficacy of the procedure was also analyzed by measuring valve function.

At the 30-day follow-up point, the researchers found that MACCE occurred in 8.3 percent of patients. The rates of total mortality and cardiac mortality were 4.5 percent and 2.2 percent, respectively, and the stroke rate was 2.9 percent. Life-threatening or disabling bleeding was observed in 4 percent of patients. The research team also found a persistent improvement in aortic valve function, accompanied by a better exercise capacity.

“The study’s conclusion is straightforward — that TAVI is effective and is associated with low mortality in the presence of an improvement in symptoms,” said Linke. “We included patients that were considered high operative risk and non-operable, and they definitely showed symptom improvement. The procedure provided great relief for the patients, as they did much better after implantation.”

The study was funded by Medtronic Inc. Linke disclosed that he is a consultant to Medtronic.

For more information: www.acc.org

Related Content

blood pressure, gray zone, hypertension, personalized treatment, Circulation journal study, CT calcium scores
News | Hypertension| January 23, 2017
Using data from a national study, Johns Hopkins researchers determined that using heart computed tomography (CT) scans...
NCDR, ACC, JACC, American College of Cardiology, national trends, heart disease treatments, trends in cardiovascular care
News | Cath Lab| January 23, 2017
January 23, 2017 — Over 93 percent of heart attack patients are receiving stents within the guideline-recommended thr
Biotronik, BioMonitor 2 implantable cardiac monitor, BioInsight clinical study, first patients enrolled
News | Implantable Cardiac Monitor (ICM)| January 20, 2017
Biotronik has enrolled the first patients in the BioInsight clinical study evaluating the safety and feasibility of...
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
Overlay Init