Cardiologists are first in world to use new leaflet-splitting technique during TAVR
Interventional cardiologists have performed the first transcatheter aortic valve replacement (TAVR) procedures of their kind, using transcatheter aortic root tricuspidization (ART) to treat multiple patients with bicuspid aortic stenosis (AS). The group wrote about this first-in-human experience in JACC: Cardiovascular Interventions.[1]
“Bicuspid aortic valve (BAV) anatomy remains a key limitation of TAVR due to leaflet fusion, calcified raphe and geometric asymmetry that constrain valve expansion,” wrote first author Danny Dvir, MD, director of interventional cardiology at the Shaare Zedek Medical Center, and colleagues. “ART represents a novel approach that applies a leaflet-splitting technique to bicuspid valves with the aim of transforming calcified fused leaflet complex into a more symmetric trileaflet configuration. We report the first-inhuman experience with ART in patients with stenotic bicuspid anatomy prior to TAVR.”
A total of seven patents with BAV anatomy underwent ART-assisted TAVR. The mean age was 64.6 years old, 86% were men and the median Society of Thoracic Surgeons score was 3.6%. All patients presented with symptomatic, severe AS. No patients had moderate or greater aortic regurgitation.
All procedures were performed using transfemoral access, 86% were performed using transesophageal echocardiographic guidance and 71% were performed using cerebral embolic protection devices to limit the risk of stroke.
A case example of transcatheter aortic root tricuspidization (ART) for a type 1 bicuspid aortic valve. Pre procedural CT images (A,B and C), index ART and TAVR procedure (D,E,F and G), and post procedural CT images (H and I). Images and caption courtesy of JACC: Cardiovascular Interventions and Dvir et al.
CT imaging was performed prior to each procedure to help guide the team through ART. An electrified guidewire was advanced through each patient’s leaflet and then snared in the left ventricle to create a laceration system. “Controlled electrosurgical energy” was then delivered to split the fused leaflet, and TAVR was performed immediately.
Each attempted ART was a success, and all procedures were a success. The median ART procedural time was 46 minutes, and the median total procedure time was 125 minutes. A majority of patients received a balloon-expandable TAVR valve.
No major vascular complications were reported. One nonsustained ventricular tachycardia was reported, but it did not require intervention. In addition, one episode of “brief hemodynamic instability” was reported after leaflet splitting, but resolved after the TAVR was complete.
No deaths or neurological events were reported after 30 days, the authors added. Two patients did require permanent pacemaker implantation, a known side effect of TAVR with or without ART. The reported 30-day hemodynamic performance was favorable.
Overall, the authors see their first-in-human study as a success.
“While previous aortic leaflet modification techniques aimed to either prevent coronary obstruction or to treat regurgitant noncalcified valves, ART directly targets the constraint of calcified bicuspid valves,” they wrote. “This represents a conceptual shift: from adapting transcatheter devices to bicuspid anatomy, to modifying the anatomy itself to accommodate the device.”
The group concluded by calling for additional research into this strategy to “optimize outcomes in this growing bicuspid TAVR population.”
Click here to read the full study in JACC: Cardiovascular Interventions, an American College of Cardiology journal.
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