Mortality After Transvascular TAVR Continues to Decline

By Will Boggs MD

NEW YORK (Reuters Health) - In-hospital mortality after transvascular transcatheter aortic valve replacement (TV-TAVR) dropped below that after isolated surgical aortic valve replacement (iSAVR) for the first time in 2016, according to a new German study.

“The overall in-hospital mortality is numerically lower in TAVR patients, in comparison to SAVR, despite the fact that TAVR patients have been older for more than a decade and had a significantly higher risk profile,” Dr. Helge Moellmann from St-Johannes-Hospital, in Dortmund, told Reuters Health by email.

Based on excellent outcomes and reduced complications over the years, TAVR is now recommended over iSAVR by the European Society of Cardiology in patients 75 years and older presenting with a Society of Thoracic Surgery (STS) score of 4% or higher or a logistic EuroSCORE I of 10% or higher.

Dr. Moellmann and colleagues used data from Germany's Institute for Quality Assurance and Transparency in Healthcare to evaluate patient risk profiles, procedural success, complication rates and outcomes of TV-TAVR and iSAVR procedures performed there, focusing on the years 2014 through 2016.

While the 15,050 TV-TAVR procedures in 2016 represented a 14.6% increase over 2015, patients treated with TV-TAVR showed a relatively constant risk profile during 2016.

Between 2014 and 2016, there were continuous decreases in procedure time, radiation time, and the amount of contrast medium used.

Compared with 2015, 2016 was marked by a higher rate of intraprocedural vascular complications, a slight decrease in aortic regurgitation rates, and stable or decreased rates of all other complications.

Post-procedural complication rates decreased in 2016, including significant decreases in the frequency of new permanent pacemaker implantations, post-procedural vascular complications, and cardiopulmonary resuscitation, the researchers write in the European Heart Journal, online December 8.

In-hospital mortality after TV-TAVR declined from 3.8% in 2014 and 3.4% in 2015 to 2.6% in 2016, which was slightly lower than the 2.9% after iSAVR.

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In-hospital mortality differences in favor of TV-TAVR were statistically significant for intermediate-risk, high-risk and very-high-risk patients, whereas mortality did not differ significantly between TV-TAVR and iSAVR in the low-risk group.

“The results demonstrate that TAVR is ‘ready for prime time,‘” Dr. Moellmann said. “The initial belief that only high-risk patients should be treated with this approach due to safety concerns is definitely outdated. The results not only confirm the latest results from randomized trials that intermediate-risk patients are safely treated with TAVR, but also that suitable low-risk patients may well benefit from this less invasive approach.”

Dr. Thierry Folliguet from Universite de Lorraine, in Nancy, France, who has studied various aspects of TAVR, told Reuters Health by email, "TV-TAVR should only be reserved for older patients >75 years old since we have no good data on structural valvular dysfunction, and also the follow-up of most series is too short to (draw conclusions), whereas for surgery we have 20 years’ follow-up studies. So, we have to wait for the data before saying TAVR is the standard of care.”

“TAVR is being developed by the industry, and all the randomized controlled trials are sponsored by the industry and are being conducted in the U.S.,” he noted.

He added that the results cannot be applied to the rest of the world “due to differences in morphotype,” with TAVR showing worse results in patients with a lower BMI. “The same is true for larger valves >27 mm,” said Dr. Folliguet, who was not involved in the new research. “So, I would encourage (physicians) to be cautious and to stick to evidence-based medicine and not industry-based medicine.”

Dr. Moellman has received speaker fees from several medical-device makers. Several of his co-authors also reported industry ties.

SOURCE: https://bit.ly/2krFYPR

Eur Heart J 2017.

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