Registries Show Low Complication Rates With New Heart Valves

MIAMI BEACH, FLA.—After many years of experience with new-generation transcatheter heart valves, several European registries are starting to show high degrees of device success and positive clinical outcomes using newer percutaneous aortic valve prostheses. Updates from the SOURCE, PREVAIL XT and FRANCE 2 registries were presented at the Valvular Heart Disease Summit at TCT 2012.

Martyn Thomas, MD, at St. Thomas’ Hospital in London, presented data that compared the SOURCE and SOURCE XT registries. The Sapien XT (Edwards) has been used in Europe since 2010; the XT has a cobalt-chromium frame, unlike the earlier Sapien device; the newer iteration also added a 29-mm version in addition to 23-mm and 26-mm valves. The 30-day all-cause mortality among the 2,681 SOURCE XT patients was 6.3%, compared to 9.6% for the 2,307 SOURCE patients (P<.0001). Cardiac mortality was also significantly reduced with the XT device at 2.6% compared to 4.0% (P=.0072).

Registeries Show Low Figure

“I’m glad to say that the incidence of [procedural] complications is now extremely low,” Thomas said. Aortic dissection (0.1% vs. 0.8%; P=.0003), annular dissection (0.0% vs. 0.2%; P=.0159), and coronary occlusion (0.4% vs. 0.1%; P=.0254) were all significantly lower in the SOURCE XT patients than SOURCE patients. Also, Thomas said that physicians appear to have learned how to manage major complications in these patients more effectively, with dropping mortality rates following major vascular and bleeding complications (see Figure).


Updated data from the PREVAIL EU TA and TF registries, designed to evaluate the SAPIEN XT device as well as the new-generation delivery systems NovaFlex and Ascendra 2, were presented by Stefan Sack, MD, of Academic General Hospital Munich in Germany. The TA registry included 212 patients undergoing TAVR via transapical access using the Ascendra 2, and the NovaFlex cohort included 141 patients who received the device using transfemoral access. All-cause mortality was 8.5% at 30 days and 17% at one year in the transfemoral patients; in the transapical patients, all-cause mortality was similar at 7.5% and 17% at 30 days and one year, respectively. Other outcomes including stroke, MI, and acute kidney injury were also similar between the two approaches, although major vascular complications were higher in the transfemoral patients.

Sack said the effectiveness of Sapien XT along with the new delivery systems is consistent with older generations, and the safety profile is excellent. He also pointed out that the incidence of paravalvular leak is low, particularly with the 29 mm Sapien XT option.

CoreValve vs. Sapien

In the FRANCE 2 registry, 3,933 consecutive patients at 34 European centers received either a Sapien (67%) or CoreValve (Medtronic) device (33%). Most patients in the registry (73%) underwent the procedure using a transfemoral approach. Results were presented by Hélène Eltchaninoff, MD, of the University of Rouen in France.

The major difference seen between the two devices was the rate of patients who required a new pacemaker — 11.8% for Sapien and 24% for CoreValve. Vascular complications and stroke were similar between the two groups. The mortality rate among all patients after one year was 24.1%, and the cardiovascular mortality rate was 13.6%. Several factors were predictive of 12-month mortality, including transapical approach and NYHA functional class.

“This registry demonstrates a high success rate with excellent and sustained hemodynamic and clinical improvement,” Eltchaninoff said.

  • Dr. Eltchaninoff reports receiving consultant fees/honoraria from Edwards Lifesciences.
  • Dr. Sack reports receiving financial support from numerous companies.
  • Dr. Thomas reports receiving grant/research support from Edwards Lifesciences and Boston Scientific, and consultant fees/honoraria from Boston Scientific, Edwards Lifesciences and St. Jude Medical.