TAVI Improves Aortic Valve Function, Lowers Stroke and Mortality Rates

Chicago—Inoperable or high-risk patients with severe aortic stenosis who underwent transcatheter aortic valve implantation (TAVI) using the CoreValve® system had improved aortic valve function and low stroke and mortality rates after 1- and 6-month follow-up. Axel Linke, MD, professor of cardiology at the University of Leipzig Heart Center in Leipzig, Germany, discussed the results of ADVANCE (Treatment of High Risk Aortic Stenosis Patients with Transcatheter Medtronic CoreValve Implantation), an international multicenter study, at the ACC meeting. Medtronic, Inc, the device’s manufacturer, funded the study. The US Food and Drug Administration has not approved the device, but it has been implanted in 26,000 people in >50 countries outside the United States since 2007, according to Medtronic. Dr. Linke, lead author of the study, said ADVANCE was the largest prospective, fully monitored TAVI study to date. It was also the first to define adverse events using the Valve Academic Research Consortium’s standards, which include all-cause and cardiovascular mortality, myocardial infarction (MI), stroke, life-threatening bleeding, major vascular complications, and acute kidney injury. TAVI allows physicians to treat aortic valve stenosis without having to perform open-heart surgery, Dr. Linke said. He added that previous studies had shown that transcatheter aortic valve replacement surgery was superior to medical therapy for patients who were inoperable. The procedure was also noninferior to conventional aortic valve therapy for high-risk patients. Although ADVANCE was not a randomized controlled study, Dr. Linke said the researchers believed there was a lack of information about a real-world population of patients who had significant stenosis and were of high operative risk. In this study, the researchers enrolled 1015 patients between March 2010 and July 2011 at 44 centers in 12 countries in Western Europe, Asia, and South America. Each center had conducted ≥40 TAVI procedures before the trial began. At baseline, the median age of patients was 81 years, and 50.6% of patients were females. The systems were implanted in 996 patients, and 30-day follow-up occurred in 950 patients. The primary end point was major adverse cardiac and cerebrovascular events (MACCEs), defined as a composite of all-cause mortality, MI, emergent cardiac surgery or percutaneous reintervention, or stroke. After 30 days, 8.3% of patients had reached MACCE, including 4.5% with all-cause mortality, 2.9% with stroke, 1.7% with emergent cardiac surgery or percutaneous reintervention, and 0.2% with MI. “They were dramatically improved by the procedure,” Dr. Linke said. “Already at 1 month, they felt a lot better.” He added that the procedure was “extremely safe” and was associated with an improvement in hemodynamics, particularly with the function of the aortic valve. At 30 days, there were few major valve-related complications: 0.3% had valve embolization, 0.1% had conversion to open aortic valve replacement, and 0.1% had a coronary compromised. The stroke rate was also low, according to Dr. Linke: 2.9% at 1 month and <3.5% at 6-month follow-up. The all-cause survival rate was 95.5% at 30 days and 87.2% at 6 months. “This was extraordinary,” Dr. Linke said.