Procedure to prevent coronary obstruction from TAVR safe
Click Here to Manage Email Alerts
A procedure to prevent coronary artery obstruction in patients undergoing transcatheter aortic valve replacement was safe at 30 days, researchers reported at the virtual Cardiovascular Research Technologies meeting.
“Coronary obstruction is a rare but devastating complication of TAVR,” Jaffar M. Khan, BM BCh, PhD, staff clinician at the NHLBI and interventional fellow at Medstar Washington Hospital Center, said during a presentation. “BASILICA is a novel technique to lacerate the aortic leaflets to prevent coronary artery obstruction. The BASILICA IDE trial demonstrated efficacy in preventing coronary obstruction, and also feasibility in expert centers. What is still lacking is a demonstration of procedure safety. ... The purpose of this study was to determine the safety of the BASILICA procedure and also to determine the feasibility of the BASILICA procedure in a real-world setting.”
Khan and colleagues retrospectively analyzed 214 patients (mean age, 75 years; 69% women; 60.1% with balloon-expandable valve; 39.9% with self-expanding valve) from the International BASILICA Registry who had the procedure from June 2017 to December 2020. The results were simultaneously published in JACC: Cardiovascular Interventions.
The procedural success rate was 86.9%, with 94.9% of patients having successful traversal, 94.4% having successful laceration, 95.3% not having coronary obstruction during the procedure, 93% not requiring emergency surgery or reintervention, and no patients dying during the procedure, Khan said.
At 30 days, 2.8% of patients died, 2.8% had a stroke, 0.5% had a disabling stroke, 3.3% had a life-threatening bleed, 3.8% had a major vascular complication, 4.3% had stage 2 or 3 acute kidney injury, 5.7% had culprit or nonculprit coronary obstruction and 1.4% required reintervention, for a total of 82.8% who met the Valve Academic Research Consortium (VARC)-2 30-day safety endpoint, he said.
The 1-year survival rate was 83.9%, according to the researchers.
There were no differences in outcomes between those who had single-leaflet or two-leaflet BASILICA, between those who had native or bioprosthetic valves or between those who had cerebral embolic protection and those who did not, Khan and colleagues found.
The registry “demonstrates that BASILICA is safe, with low rates of stroke and death, [and] that BASILICA is feasible in the real world, whether in centers with experience or with appropriate training, with low rates of coronary artery obstruction,” Khan said during the presentation. “We feel the data are reassuring and should facilitate wider dissemination of the BASILICA procedure at high-volume centers.”
Reference:
Collapse
Khan JM, et al. Landmark session: Late-breaking trials – Structural. Presented at: Cardiovascular Research Technologies; Feb. 13-April 24, 2021 (virtual meeting).
Click Here to Manage Email Alerts