MASSDEVICE ON CALL — Major complications occur frequently in patients undergoing transcatheter aortic valve implantation procedures, according to an analysis of data from the Edwards Lifesciences (NYSE:EW) Partner TAVI trial published in Interventional Surgery.

Combining the trial’s 2 cohorts (patients unable to undergo open heart surgery to replace the valve and patients at high risk for surgery), major vascular complications occurred in 15.3% of treated patients within 30 days of the procedure, heartwire reported.

The complications included vascular dissection, peroration, and access-site hematoma, which were associated with significantly higher 30-day rates of major bleeding, transfusions, and renal failure requiring dialysis, as well as significantly higher rates of 30-day and 1-year mortality.

"The study is really a reflection of first-generation devices, with large-diameter sheaths, 22-F and 24-F sheath sizes, and early experiences, with physicians often doing their first cases," lead investigator Dr. Philippe Généreux told the website. "So everybody is concerned that the incidence of complications is high and that there is an impact on mortality, which is true, but these are patients who were very sick, the catheters were very big, and the operators were early on in the learning curve. Right now, the rate of major vascular complications is probably in the single digits. With the new devices, the new catheters and sheath sizes, we’re probably down to around 1% to 5%. This study is more of a landmark study to assess the rate and impact of vascular complications that we can use to compare with newer-generation devices."

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