Registry Results Presented on Current TAVI Practice in Europe

August 29, 2012—The European Society of Cardiology (ESC) announced that the first results of the Transcatheter Valve Treatment sentinel pilot registry were presented by registry Chairman Professor Carlo Di Mario, MD, at the ESC Congress 2012 in Munich, Germany. The registry is part of the ESC's EURObservational Research Programme of surveys and registries. The presentation showed the current usage of the most modern transcatheter aortic valve implantation (TAVI) valves and catheters in Europe and compared indications, techniques, and outcomes between different countries.

The ESC stated that the research presented by Prof. Di Mario indicated that European cardiologists are restricting the use of TAVI to very old or very sick patients at high surgical risk. The registry included 4,571 patients who underwent the TAVI procedure using the Sapien XT device (Edwards Lifesciences, Irvine, CA) or the CoreValve device (Medtronic, Inc., Minneapolis, MN) between January 2011 and May 2012. Patients were from 137 centers in Israel and nine countries in Europe (Czech Republic, France, Spain, Switzerland, UK, Italy, Poland, Belgium, and Germany).

In the ESC press release, Prof. Di Mario commented, “TAVI is a new technology that has been introduced in Europe, but many question marks remain on which patients are most suitable. We set up this registry because it was important to have a clear picture of clinical practice in Europe. Since our study was conducted during 2011 to 2012, we only included the very latest valves and delivery systems, and this, together with the increased operator experience, probably explains the reduction in complications from previous studies and registries.”

According to the ESC announcement, the average age of patients was 81.4 ± 7.1 years, with equal numbers of men and women. There was a high prevalence of comorbidities in all patients, but patients who were 80 years of age or older had a greater incidence of diabetes, chronic obstructive pulmonary disease, extracardiac arteriopathy (carotid and peripheral), permanent renal dialysis, previous myocardial infarction, previous cardiac surgery or percutaneous coronary intervention, and previous aortic valve replacement (valve-in-valve procedure). “This shows that the use of TAVI in younger patients has been restricted to those with more comorbidities, who therefore have high surgical risks,” commented Prof. Di Mario.

The ESC press release further stated that the overall in-hospital mortality rate was 7.4%. There were no significant differences in in-hospital mortality based on valve type (6.7% CoreValve, 7.9% Sapien XT; P = .15), but there were significant differences based on the approach site (transfemoral 5.9%, transapical 12.8%, transsubclavian and other approaches 9.7%; P < .01). The most frequent complication was bleeding requiring blood transfusion(s) with an incidence rate of > 20% for the transapical and transsubclavian approaches and 15% for the transfemoral approach (P < .01).

The need to implant a permanent pacemaker was another frequent complication, with an overall incidence of 13.2%. The incidence of this complication was significantly greater in patients who received the CoreValve device versus patients who received the Sapien XT valve (23.4% vs 6%; P < .01).

The ESC reported that the study found no other differences in the incidence of in-hospital complications between the two valve types. There was a low and similar incidence of major vascular complications (3.1%), stroke (1.8%), myocardial infarction (0.9%), and other complications. The length of hospital stay was 9.3 ± 8.1 days. There was wide variation between countries, from 7 days in Switzerland to more than 12 days in Poland. Patients who received general anesthesia had longer hospital stays than patients who received local anesthesia (10.2 ± 8 .7 days vs 7.9 ± 6.1 days; P < .01). Hospital stays of more than 10 days occurred in 43.8% of patients treated with a transapical approach, 39.5% treated with other surgical approaches, and 22% of patients treated transfemorally.

“Anesthesia has a big influence on cost, duration of the procedure, and length of hospital stay,” stated Prof. Di Mario. “There are big differences between countries in the type of anesthesia used. Poland and the UK conduct most transfemoral procedures under general anesthesia while Switzerland and Italy use local anesthesia for more than 60% of these procedures.”

Pharmacological treatment varied greatly between countries. There was relatively low use of aspirin (64.3%) and clopidogrel or other thienopyridines (32.6%) at discharge. Prof. Di Mario observed, “This finding suggests poor compliance with the recommended strategy of using a combination of the two drugs at discharge after TAVI.”

In the ESC announcement, Prof. Di Mario summed up the findings, “With an in-hospital mortality of 7.3%, this contemporary registry of the most up-to-date valves and delivery catheters shows that TAVI remains a high-risk procedure when applied to very old patients or patients with significant comorbidities who are poor surgical candidates.” He continued, “We now have a clear understanding of how TAVI is being used in these 10 countries. In the majority of cases, patients are very old and very sick, with lots of comorbidities, which would have made their journey to surgery a nightmare.”

Prof. Di Mario concluded, “The next step we are considering will be to launch a permanent registry that involves all countries in Europe. Collecting information on how devices are used, whether they are used appropriately, and how practice varies between countries offers enormous opportunities to provide data to regulatory authorities, monitor adherence to best practice guidelines, and improve care for patients.”