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More than 15% of patients treated with first-generation versions of transcatheter aortic heart valves have majopr vascular complications from the procedure, according to a new analysis of data from Edwards Lifesciences' Partner trial.

MassDevice On Call

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.

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