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Balloon-expandable TAVR system safe in very large annuli
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Transcatheter aortic valve replacement with a 29-mm balloon-expandable valve beyond manufacturer-recommended range is safe and conferred acceptable rates of paravalvular leak in patients with extremely large annuli, according to results published in JACC: Cardiovascular Interventions.
“TAVR in extremely large annuli has been previously reported in small case series, but larger experience has not been described,” Gilbert H. L. Tang, MD, MSc, MBA, surgical director of the structural heart program at Mount Sinai Health System and associate professor of cardiovascular surgery at Icahn School of Medicine at Mount Sinai, and colleagues wrote in the study background.
Tang and colleagues enrolled 74 patients in 16 centers with mean area 721 ± 38 mm2 (range, 684-852) who underwent TAVR with the 29-mm balloon-expandable valve (Sapien 3, Edwards Lifesciences) from 2013 to 2017. The largest manufacturer-recommended annular area for the system is 683 mm2.
Ninety-five percent of patients underwent TAVR via the transfemoral approach and 39% received conscious sedation.
The researchers retrospectively analyzed patient, anatomic and procedural characteristics, and reported Valve Academic Research Consortium (VARC)-2 outcomes.
There was 100% procedural success rate with two deaths, one stroke and two major vascular complications at 30 days, the researchers wrote.
Seventeen percent of patients experienced new left bundle branch block and 6.3% required a new permanent pacemaker, according to the study.
Echocardiography at 30 days showed mild paravalvular leak occurred in 22.3% of patients, while 6.9% had moderate paravalvular leak and none had severe paravalvular leak.
“We demonstrated the feasibility of [Sapien 3] TAVR in annuli > 683 mm2 with acceptable [paravalvular leak] and pacemaker rates. [Left ventricular outflow tract] dimensions and annular eccentricity were associated with [paravalvular leak] in this patient group,” Tang and colleagues wrote. “Longer follow-up will determine valve durability and postprocedural [multidetector] CT will help identify potential mechanisms of [paravalvular leak] in patients with extremely large annuli who undergo [Sapien 3] TAVR.”
According to a related editorial from Julinda Mehilli, MD, FESC, and David Jocheim, MD, from the department of cardiology at Munich University Clinic at Ludwig-Maximilians University, the findings offer operators “more certainty in [this] challenging subset of patients and gives us some important insights of the prosthesis performance under these exceptional conditions. Considering the ... limitations, long-term clinical and echocardiographic follow-ups for evaluation of valve durability in accordance to standardized definitions are eagerly waited, before offering this treatment option to younger or low-operative-risk patients.” – by Dave Quaile
Disclosures: Tang reports he is a physician proctor for Edwards Lifesciences and Medtronic. Please see the study for all other authors’ relevant financial disclosures. Jocheim reports no relevant financial disclosures. Mehilli reports she has received lecture fees from Abbott Vascular, Biotronik, Boston Scientific and Edwards Lifesciences and institutional research grants from Abbott Vascular and Edwards Lifesciences.
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