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

PFO occluder, amplatzer
Feature | Structural Heart Occluders| May 27, 2016 | Dave Fornell
May 27, 2016 — A U.S.
radial access, transradial
Feature | Radial Access| May 27, 2016 | Dave Fornell
The use of transradial artery vascular access for percutaneous coronary intervention (PCI) in the United States has s
Ambio Health telemonitoring system, LifeBridge Health Cardiovascular Institute, Baltimore, pilot study
News | Remote Monitoring| May 26, 2016
The LifeBridge Health Cardiovascular Institute, Baltimore, has launched a pilot study to evaluate the potential...
cath lab, radiation exposure, glocoma
Feature | Radiation Dose Management| May 26, 2016 | Dave Fornell
May 27, 2016 — Radiation exposure to cath lab staff and physicians has seen growing concern in recent years, as the p
Edwards, Sapien 3, SOURCE 3 Registry, EuroPCR 2016
News | Heart Valve Technology| May 24, 2016
Thirty-day data from the European post-approval study of the Edwards Sapien 3 transcatheter aortic heart valve...
CardiAQ, Neovasc, lawsuit, TMVR
News | Business| May 24, 2016
Edwards Lifesciences Corp. announced that a federal jury in Boston returned a verdict in favor of CardiAQ in a lawsuit...
News | Cath Lab| May 24, 2016
The Society for Cardiovascular Angiography and Interventions (SCAI) 2016 Scientific Sessions took place May 4-7, 2016
HeartFlow, FFR-CT, ruptured coronary plaques, EMERALD study, EuroPCR 2016
News | CT Angiography (CTA)| May 23, 2016
First-in-human data presented at EuroPCR 2016 demonstrate that hemodynamic data from HeartFlow Inc. may help predict...
Mitralign, Series E funding, Trialign, MPAS
News | Heart Valve Technology| May 23, 2016
Mitralign Inc. announced it has raised $39.8 million to date in a Series E equity round of financing.
TAVR outcomes, aortic valve gradient, JACC study
News | Heart Valve Technology| May 23, 2016
Patients with a combination of left ventricular dysfunction and low aortic valve gradient have higher mortality rates...
Overlay Init