Recent research has proven that transcatheter aortic valve implantation (TAVI) may be a good and safe alternative to surgery for patients with severe aortic stenosis. In fact, results of the U.K. TAVI Registry published online Oct. 19 in the Journal of the American College of Cardiology added to these data showing that long-term survival after a TAVI procedure was “encouraging” in the high-risk patient population; however, a large number of patients died within the first year.
In an accompanying editorial, researchers called TAVI a “promising technique” and said that patient selection will remain important as the procedure's use progresses.
Using the U.K. TAVI (United Kingdom Transcatheter Aortic Valve Implantation) Registry, Neil E. Moat, MBBS, MS, of the Royal Brompton and Harefield National Health Service (NHS) Foundation Trust, London, and colleagues set out to evaluate outcomes data beyond one year of TAVI procedures.
The registry collected data on 870 patients undergoing 877 TAVI procedures. The follow-up period ranged from 11 to 46 months. During the study period, the number of TAVI procedures skyrocketed from just 44 in 2007 to 538 in 2009.
Moat and colleagues reported survival at 30 days to be 92.9 percent. Survival was 78.6 percent at one year and 73.7 percent at two years. In a univariate model, the researchers reported that survival was adversely affected by renal dysfunction, the presence of coronary artery disease and a nontransfemoral approach. Left ventricular function with an ejection fraction of more than 30 percent, presence of moderate/severe aortic regurgitation and chronic obstructive pulmonary disease were independent predictors of mortality.
The researchers reported that 9.6 percent of patients died between 30 days and six months; 4.7 percent of patients died six months to one year after the procedure. One-year mortality was 18.5 percent for patients undergoing the transfemoral approach and 22.7 percent for those undergoing the nontransfemoral approach.
The researchers reported that the incidence of stroke and MI was 4.1 and 1.3 percent, respectively.
“These data encompass the learning curve of all units with this technique,” Moat et al wrote. “The observation that 30-day and midterm mortality was equivalent in proctored cases and in nonproctored cases, and in the first 20 cases compared with subsequent cases in each unit, reflects well on the process of education, training, and mentorship established by both of the companies with current commercially available devices.”
In an accompanying editorial, Alec Vahanian, MD, of the Hôpital Bichât in Paris, and colleagues wrote, “Transcatheter aortic valve implantation (TAVI) is now increasingly performed, and more than 30,000 patients with severe aortic stenosis and contraindications to or high risk for surgery have been treated so far.
“It is mandatory to continue identifying predictors of poor immediate outcome and, perhaps even more importantly, of subsequent attrition, which occurs frequently in the current series with fatality rates of more than 30 percent at two years,” they wrote.
The fact that Moat and colleagues reported that low LVEF function was a predictor of mortality could show that TAVI is more effective than surgery at improving left ventricular function. While Moat and colleagues reported that chronic obstructive pulmonary disease was a predictor of mortality, Vahanian and colleagues said that the finding leads to two conclusions: It is necessary to understand whether a patient really has severe aortic stenosis and whether the contribution of noncardiologists is essential for patient selection to avoid performing TAVI in patients with a limited life expectancy.
“In conclusion, TAVI is a promising technique and the data in this registry add a significant piece of evidence in support of the statement that, for high-risk or inoperable patients, when performed in properly trained centers, safety is acceptable and midterm survival is satisfactory,” Vahanian and colleagues concluded.