麻豆果冻传媒影音

PARIS -- As transcatheter aortic valve implantation (TAVI) moves into lower risk groups in real-world practice, the outcomes in multinational registry studies continue to support the use of the TAVI procedure.

In the SOURCE post-marketing registry with the Sapien valve, the average surgical risk score on the EuroSCORE scale dropped from 27.6 to 25 between the first year of commercial availability after European regulatory approval in Nov. 2007 and the second year on the market (P<0.001).

Survival rates, stroke rates, and procedural success remained stable between periods while moderate to severe perivalvular leaks fell. However, 30-day major bleeding complications rose, reported Olaf Wendler, MD, PhD, of King's College Hospital in London, and colleagues here at the European Society of Cardiology's EuroPCR meeting.

A separate meta-analysis of TAVI with CoreValve across national registries found similar outcomes despite an average EuroSCORE of 21.3, Carlos E. Ruiz, MD, of Lenox Hill Hospital in New York City, and colleagues reported at the same late-breaking session.

The data "correlate nicely" with those from the randomized PARTNER trial in the U.S., which used the Sapien valve, despite the selected patient populations in that trial, Wendler noted at a EuroPCR press conference.

One-year mortality rates based on Ruiz' meta-analysis were:

• 22.2% with transfemoral access and 29% with transapical access in cohort A of PARTNER among patients who were high-risk surgical candidates
• 19.9% with transfemoral access and 25.8% with transapical access in the SOURCE registry
• 17.1% overall in the meta-analysis of seven national registries

SOURCE included data only from European centers with nearly complete reporting to present an "all comers" picture of outcomes for consecutive patients treated with the Sapien bioprosthesis. It was divided into two cohorts with roughly an equivalent numbers of patients (1,038 from Nov. 2007 to Jan. 2009 and 1,269 from Feb. 2009 to Dec. 2009) to show trends over time.

In the intention-t0-treat analysis, the surgical risk group with the greatest increase in TAVI between the two time periods were those with a logistic EuroSCORE under 20 (32.8% to 43.7%, P<0.0001). The proportion of patients with EuroSCOREs of 20-40, and over 40, declined significantly between the two time periods.

Procedural success rates rose slightly although not significantly (91.7% to 93.2%, P=0.17). Conversion to surgery rates didn't change significantly (0.5% to 1.0%, P=0.14).

Moderate or severe paravalvular leaks, which typically require revision, dropped from 7.2% to 3.9% (P<0.001) as a procedural complication and from 6.1% to 2.7% as an adverse event within 30 days.

Major bleeding events rose from 2.0% to 4.3% (P=0.003). Cardiopulmonary bypass use, while still uncommon, rose from 0.1% to 1.2% (P=0.02).

Stroke risks remained fairly steady at 2.5% in the first period and 2.8% in the second (P=0.70). Need for a pacemaker, renal complications, and vascular-access related complications remained unchanged as well.

Notably, concern arose from higher stroke risk with transapical TAVI in cohort A of PARTNER compared with surgery (3.8% versus 2.3% at 30 days, P=NS).

However, in the SOURCE registry, transapical TAVI actually had a numerically lower 30-day stroke rate than transfemoral TAVI (2.5% and 2.9%, P=0.60).

Survival at two years was an "excellent" 67.7% overall, with nearly identical rates between periods for all mortality measures.

Interventional cardiologist Imad Nadra, MD, PhD, of Trent Cardiac Center in Nottingham, England, called the SOURCE data impressive.

"It's the best we can get in real life data," he told MedPage Today.

He acknowledged that participating centers were likely those with the most experience with TAVI, "but experienced hands go through the learning curve too."

The meta-analysis by Ruiz and colleagues covered a broader spectrum of centers, with national registries from Australia and New Zealand, Italy, Belgium, Spain, France, Britain, and Germany.

Altogether the 2,156 patients in those registries treated with CoreValve prostheses indicated the following outcomes rates:

• 97.8% procedural success
• 93.4% 30-day survival
• 2.8% stroke
• 28.7% permanent pacemaker
• 4.2% vascular complications

Ruiz cautioned that results somewhat varied between countries, noting that patient selection criteria varied among them. Other limitations were that most of the national registries used self-reported clinical outcomes without prospective monitoring or standardized definitions for clinical events, making under reporting of events likely, he added.

For such reasons, it's time to move from smaller national registries to international registries, suggested session co-chair Carlo Di Mario, MD, PhD, of Imperial College London.

A bigger concern, though, is how results will hold up over time and if percutaneously implanted valves will prove as durable as those implanted surgically.

"We're into the third or fourth year of its usage," interventional cardiologist Kamran Baig, MD, also of Trent Cardiac Center, commented in an interview with MedPage Today. He pointed out that that the total experience numbers only into the thousands, and that may not be great enough yet to show rarer problems.