Randomized trial of surgical cutdown versus percutaneous access in transfemoral TAVR

Abstract

Objectives: To compare iliofemoral arterial complications with transfemoral transcatheter aortic valve replacement (TF-TAVR) utilizing surgical cutdown versus percutaneous access with closure devices in a randomized trial. Background: Major vascular complications following TAVR are a significant risk of the procedure. There are no randomized data comparing whether access method in TF-TAVR influences the risk of such complications. Methods: From June to December 2011, 30 consecutive patients undergoing TF-TAVR were randomized to either surgical cutdown (C) or percutaneous (P) access. Subjects underwent preoperative CT scans, pre-and post-operative bilateral femoral arterial ultrasound and angiography. The primary endpoint was the composite of major and minor vascular complications at 30 days, as defined by the Valve Academic Research Consortium-2. Multivariate predictors of vascular complications were identified. Results: Of the 30 subjects enrolled, 27 were treated with the randomized method of access as randomized. Iliofemoral complications were observed in eight patients (26.7%; C 5 4, P 5 4), all of which were dissections and/or stenoses that required percutaneous and/or surgical intervention. There were two (13.3%) major and two (13.3%) minor complications in each group. Two covariates that were significantly associated with vascular complications included female sex and baseline femoral arterial velocity on ultrasound. Conclusions: While surgical cutdown in TF-TAVR is the recommended access for new centers initiating a TAVR program, this small randomized pilot study suggests the lesser invasive percutaneous method in an experienced center is equivalent in safety to the surgical method. Doppler ultrasound may be useful in predicting complications prior to the procedure. V C 2013 Wiley Periodicals, Inc.

Surgical cutdown versus percutaneous access in transfemoral transcatheter aortic valve implantation: Insights from the Brazilian TAVI registry

“…Our results are in line with previous studies that compared the two different vascular access techniques . Two retrospective analyses and one small randomized study in patients undergoing transfemoral TAVI showed acceptable immediate safety and feasibility for both strategies .…”

“…Previous studies in patients undergoing non‐TAVI endovascular aortic aneurysm repair showed that these two strategies were clinically comparable . Moreover, recently, one small randomized study and two retrospective single‐center surveys indicated that surgical and percutaneous approaches were both acutely feasible and safe for patients undergoing TAVI . Nevertheless, there is still scarce information about the impact of each vascular access technique on the long‐term outcomes of high‐risk patients undergoing TAVI.…”

Factors Associated With Vascular Complications in Patients Undergoing Balloon-Expandable Transfemoral Transcatheter Aortic Valve Replacement via Open Versus Percutaneous Approaches

“…Although it confirmed the feasibility of the PC approach, this study was underpowered to evaluate the end point of vascular outcomes. 15 An additional recent analysis showed unadjusted decreased length of stay in PC patients when compared with that in OS patients, but adjusted analyses of vascular outcomes and length of stay were not performed. 16 The largest study to date is based on the Pooled-Rotterdam-Milano-Toulouse in Collaboration (PRAGMATIC) initiative at 5 European centers.…”

Percutaneous management of vascular access in transfemoral transcatheter aortic valve implantation

“…In all these phases vascular access complications such as plaque disruption, local dissection, aneurysm formation, stenosis/occlusion, and even acute thrombosis, with consequent acute limb ischemia, can occur [21,22] . Moreover, the lesser invasive percutaneous method in an experienced center is associated with similar rates of major and minor vascular complications [23] and with lower access site infection and bleeding, and shorter hospital stay compared to the surgical approach [24] . While the Edwards SAPIEN valve is implanted through a 22 or 24 F arterial sheath (about 8 and 9 mm external diameter), the CoreValve and the Edwards SA-PIEN XT valve are delivered through a 16-20 F sheath (about 7 mm external diameter).…”