A novel device successfully closed transcaval access in the setting of transcatheter aortic valve replacement (TAVR) in all study patients, according to late-breaking trial results presented Tuesday at Cardiovascular Research Technologies (CRT) 2019.
The early feasibility study evaluated a purpose-built closure device for transcaval access.
Until now, when transcaval access has been used, an off-label nitinol cardiac occluder device is used to for closure. Toby Rogers, MD, PhD, of the National Institutes of Health’s National Heart, Lung and Blood Institute and MedStar Washington Hospital Center, said these devices were “clearly not designed to be put in holes between the aorta and (inferior vena) cava in the abdomen.”
While most patients tolerate that closure well, he said, “Clearly we would all be much more comfortable if we had something that would just be more effective and simpler to use.”
The primary endpoint is technical success at exit from the catheterization laboratory. The following are required to be counted as technical success: patient is alive, successful delivery of the transcaval device (TCD) and retrieval of the delivery system, deployment and correct positioning of a single intended TCD (repositioning and recapture, if needed, is not classified as failure), and no additional unplanned or emergency surgery or reintervention related to the TCD or delivery system. Adjunctive balloon aortic tamponade is permissible and considered consistent with technical success.
A total of 12 patients at 3 U.S. centers were enrolled from February-April 2018. Key inclusion criteria were that the patient was ineligible for femoral artery access for the selected transcatheter heart valve according to the valve manufacturer’s instructions for use, and that the patient was eligible for transcaval access based on core laboratory analysis of the baseline abdomen/pelvis computed tomography (CT).
Eight patients (66.7%) were at high or extreme risk of surgical mortality. Nine patients (75%) were moderately sedated during the procedure. Mean transcaval sheath nominal size was 15.1 +/- 2.3 Fr. The Edwards Sapien 3 valve (Edwards Lifesciences) was used in 10 patients (83%), and the CoreValve (Medtronic) was used in two patients (17%).
Successful transcaval closure with a single TCD was achieved in all patients. One patient had minor bleed (hematoma from a contralateral femoral artery access site), and one patient had one unit of packed red blood cells transfusion during TAVR but no overt bleeding, so this was classified as not clinically indicated.
Three subjects’ systolic blood pressure (SBP) fell below 90 mmHg during device deployment, but all 12 patients’ SBP recovered to above 100 mmHg after device deployment.
The primary endpoint was met in all subjects enrolled and treated with the TCD implant. The secondary endpoint, device success, was met in 10 of the 12 patients at 30 days, including follow-up CT. One patient died on post-operative day 15 from underlying pulmonary disease, and one patient developed ischemia in the leg on post-operative day 23. The ischemia was presumed to be embolic and possibly related to underlying atrial fibrillation.
The study was sponsored by the NHLBI.