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Novel transcatheter procedure before TAVR safe for severe aortic stenosis
A transcatheter procedure performed immediately before transcatheter aortic valve replacement was feasible and safe in patients with severe native or bioprosthetic aortic valve disease who were at high surgical risk, according to a study published in JACC: Cardiovascular Interventions.
“[Bioprosthetic aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction] appears to effective in preventing coronary obstruction from TAVR in subjects at high risk,” Jaffar M. Khan, MD, staff clinician at the cardiovascular branch of the NHLBI, and colleagues wrote.
Patients with high surgical risk
Researchers analyzed data from 30 patients (mean age, 76 years; 80% women) with symptomatic severe aortic stenosis or bioprosthetic aortic valve failure who were at high or prohibitive risk for surgical AVR. Patients underwent bioprosthetic aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction (BASILICA) and TAVR between Feb. 15 and July 31, 2018.
The BASILICA technique is a procedure that targets one or more leaflets that are chosen based on the coronary artery that is at risk for obstruction, according to the study.
Patients underwent CT scans at baseline and postprocedure, and transthoracic or transesophageal echocardiograms at baseline, intraprocedure, discharge and 30 days.
The primary endpoint was procedure success, which was measured upon exit from the catheterization lab. The primary safety endpoint was freedom from MACE at 30 days, defined as a composite of all stroke, all-cause mortality, acute kidney injury, life-threatening bleeding, major vascular complications, coronary artery obstruction requiring intervention and valve-related dysfunction requiring repeat procedure. Secondary endpoints were defined as hemolytic anemia, TAVR thrombosis on follow-up CT, hemodynamic instability caused by BASILICA before TAVR and technical failure related to BASILICA.
Procedure success occurred in 93% of patients. Most patients had successful leaflet traversal and laceration (95%). All patients were free from reintervention, surgery and coronary obstruction.
At 30 days, primary safety was seen in 70% of patients, which was driven by 20% of patients who had major vascular complications linked to TAVR and not BASILICA. One patient died at 30 days.
Seven percent of patients had nondisabling stroke and 3% had disabling stroke. Transient hypotension occurred in 7% of patients, which was resolved with TAVR.
“Dedicated catheter tools may make BASILICA into a relatively easy and swift adjunct to TAVR,” Khan and colleagues wrote. “At present, the BASILICA procedure is a novel technique and should be limited to high-volume centers and be performed with appropriate education and proctoring.”
Encouraging results
“These early results are encouraging enough ... to cheer on the champions of this technique,” John D. Carroll, MD, FACC, professor of medicine-cardiology, director of interventional cardiology and co-director of the cardiac and vascular center at University of Colorado School of Medicine in Aurora, wrote in a related editorial. “What the next steps are and how the questions posed will be answered are critical to define and organize. We appreciate and congratulate the creativity, skill and courage that the investigators have shown to get us to this place.” – by Darlene Dobkowski
Disclosures: Khan reports he is a co-inventor on patents assigned to NIH on catheter devices to lacerate valve leaflets. Carroll reports he is vice chair of the Society of Thoracic Surgeons-American College of Cardiology Transcatheter Valve Therapies Registry steering committee. Please see the study for all other authors’ relevant financial disclosures.