MIAMI BEACH – Using a novel balloon occlusion technique, interventional cardiologists at Columbia University have safely performed percutaneous artery closures on 95% of their patients undergoing transfemoral aortic valve implantations.
Dr. Martin B. Leon
"Open surgery is now rarely needed for femoral artery access-site closure following transfemoral TAVI [transcatheter aortic valve implantation], even with the currently used large sheaths," Dr. Martin B. Leon said at the International Symposium on Endovascular Therapy.
"A percutaneous closure device–enabled technique aided by the crossover balloon occlusion technique (CBOT) after TAVI may be a viable alternative to conventional surgical repair when used in appropriately selected patients," said Dr. Leon, professor of medicine and associate director of the center for interventional vascular therapy at Columbia University in New York.
Dr. Leon and his associates began using the CBOT on patients undergoing TAVI by a transfemoral approach in November 2008, and through last September they had used the CBOT on 56 of their 58 patients (mean age, 85 years). The two exceptions involved patients who underwent elective surgical closures because their femoral-artery anatomy was judged unsuitable for percutaneous closure.
Among the 56 who underwent percutaneous closure using the CBOT, 53 patients (95%) had a successful closure. In two of the unsuccessful patients, the closure attempt produced a perforated external iliac artery, and in the third unsuccessful case the attempt resulted in an occlusive dissection of the external iliac.
The 5% vascular complication rate in this series of 56 TAVI patients compared very favorably with the 16% rate of major vascular complications at 30 days reported by Dr. Leon and his collaborators in the results from the PARTNER (Placement of Aortic Transcatheter Valves) trial published last October, which was the pivotal trial for testing the safety and efficacy of TAVI in patients who were not candidates for valve implantation using open surgery (N. Engl. J. Med. 2010;363:1597-607). Most TAVI patients in PARTNER did not undergo the CBOT.
The CBOT involves three steps, and is a modification of the standard ipsilateral technique for balloon-assisted closure, Dr. Leon explained. First, the operator establishes access into the femoral artery contralateral to the one used for the TAVI catheter, and places a crossover sheath in the external iliac artery that is ipsilateral to the TAVI setup. Next is the insertion of a properly sized balloon with low-pressure inflation to occlude the vessel just above the arteriotomy site. Third, once this balloon has been inflated to decompress the vessel and control bleeding, the operator deploys a two-suture percutaneous closure device. (Dr. Leon uses the ProStar device.)
He recommended then assessing the closure site and reinflating the crossover balloon if the closure does not look perfect. "We don’t allow 70% lesions or minor extravasations," he said. "We’re very aggressive about getting as good a result as we can." He recommended that operators "have great respect for vascular complications during and after TAVI," and that the team "not relax until the [TAVI] sheath is removed and the access site is stable."
He also suggested "meticulous" preprocedure screening of patients, with a special emphasis on CT angiography to identify patients with problematic vascular anatomy. Features to watch for include a deep common femoral artery, a high femoral bifurcation, excessive proximal tortuosity, and atherosclerotic disease at the common femoral puncture site, especially circumferential calcification. Many TAVI candidates are very elderly and hence often have tortuous vessels and a high rate of calcification.
He also suggested that the team have proper training and experience with large-vascular access and suture-mediated percutaneous closure.
Vascular complications and their avoidance represent major issues in the performance of TAVI, Dr. Leon said. The catheters currently used to perform the procedure are large, with outside diameters exceeding 8 mm, and although the catheters come with a hydrophilic coating, this tends to wear off quickly during the procedure, making the catheters sticky and harder to maneuver safely. Smaller catheters will soon appear on the market, but for the time being, the procedure poses a potential risk for access-site closure complications, especially in older patients.
In addition, a vascular complication can have a substantial impact on patient outcome. In the PARTNER trial, patients who underwent TAVI and had a major vascular complication had a 47% mortality rate at 1 year after their procedure, compared with a 28% 1-year mortality rate among the TAVI patients who had no major vascular complication, a statistically significant difference, Dr. Leon said.
Dr. Leon said that he has been an unpaid consultant to Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic. He has been a paid consultant to Angioscore, Neovasc, and Symetis. He also has equity relationships with ATI companies, Claret, Coherex, GDS, Medinol, and Sadra.