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PARTNER: Transapical TAVR safe, effective in high-risk patients

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Society of Thoracic Surgeons 48th Annual Meeting

New data from the PARTNER trial showed that transapical transcatheter aortic valve replacement is a safe, reproducible and effective procedure for the treatment of critical aortic stenosis in a high-risk population who are not candidates for transfemoral approach.

Researchers conducted a post-hoc analysis of the PARTNER trial to compare outcomes from additional transapical TAVR experience, accumulated in a nonrandomized continued access (NRCA-TA) program (n=843) in 22 centers after the randomization period was complete, with results seen in the PARTNER Cohort A with transapical TAVR (n=104) and surgical AVR (n=92).

At 30 days, all-cause mortality occurred in 8.2% of patients in the NRCA-TA group vs. 8.7% in the Cohort A transapical group and 7.6% in the surgical AVR group. All-cause mortality increased in all groups at 1 year: 23.6% in the NRCA-TA group vs. 29.1% in the Cohort A transpical group vs. 25.3% in the surgical AVR group.

Stroke at 30 days occurred in 2% of the NRCA-TA group compared with 7% of the Cohort A transapical group and 5.5% of the surgical AVR group. Stroke at 1 year increased in all groups, occurring in 3.7% of the NRCA-TA group, 10.8% of the Cohort A transapical group and 7% of the surgical AVR group.

Additionally, NYHA functional class improved significantly at 30 days in the NRCA-TA group as compared with the PARTNER Cohort A transapical group and surgical AVR group, according to data presented at the meeting.

“These results show that the transapical approach is a safe and effective procedure. When compared with surgery from a hard endpoint standpoint of mortality and stroke, it is as good as or better than conventional surgery,” Todd M. Dewey, MD, surgical director of structural heart disease at Medical City Dallas Hospital, told Cardiology Today.

“These data are much better than the transapical arm of PARTNER Cohort A,” Dewey noted in an interview. “These are strong clinical trends that we have to be encouraged by.”

The NRCA program cohort had an average STS predicted risk for mortality of 12.4 and an average logistic EuroSCORE of 29.1. At baseline, 83.2% of patients had a history of CAD, 50.6% had previous CABG and 61.6% had significant peripheral vascular disease.

One issue of concern with TAVR is the learning curve. The researchers also found that 30-day and 1-year mortality were lower among sites that enrolled later in the trial compared with sites that were enrolled since the beginning, by 3.4% and 7.5%, respectively.

Transmission of accumulated knowledge to later adopting sites, through training and education, can lead to early results comparable to those of more experienced centers, the researchers said at the meeting. – by Casey Murphy

For more information:

• Dewey TM. Transapical aortic valve replacement for critical aortic stenosis: results from the non-randomized continued access cohort of the PARTNER Trial. Presented at: The Society of Thoracic Surgeons 48th Annual Meeting; Jan. 29-Feb.1, 2012; Fort Lauderdale, Fla.

Disclosure: Dr. Dewey is on the speakers’ bureau and received honoraria from Edwards Lifesciences and has ownership interest with Cardiapex.

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