A modified crossover technique for vascular access closure in patients undergoing transcatheter aortic valve replacement (TAVR) is safe, according to a study published in the March issue of Catheterization and Cardiovascular Interventions.
Major vascular complications are frequent after transfemoral TAVR, according to an analysis of the PARTNER (Placement of AoRTic TraNscathetER Valve) trial, and were associated with bleeding events, transfusions and increased mortality. The PARTNER study assessed the use of first-generation Edwards Lifesciences' Sapien valves and delivery systems using a 22-French or 24-French sheath in patients from Cohort B (inoperable patients with severe symptomatic aortic stenosis) and patients from Cohort A (high-risk patients). The authors observed that operator experience, femoral artery and artery diameter characteristics and the sheath-to-femoral artery ratio may have contributed to the occurrence of vascular complications.
Speculating that large caliber sheaths may be a factor in complications, Gill Louise Buchanan, MBChB, of the San Raffaele Scientific Institute in Milan, Italy, and colleagues offered an alternative approach. They developed a modified technique for percutaneous vascular access management of TAVR patients in which an over-the-wire balloon is delivered from the left radial artery rather than the femoral artery.
For the study, they enrolled 15 consecutive high-risk patients at their center between June and August of 2011 who underwent TAVR using either the Sapien XT or Medtronic’s CoreValve system. They used their crossover technique with diagnostic access through the left radial artery via a 6-French introducer sheath. They applied the Valve Academic Research Consortium (VARC) definition for procedural success.
Patients had a mean age of 79.5 years; a EuroSCORE of 19.7; a Society of Thoracic Surgeons score of 5.7; mean femoral access size of 8.1 mm; and evidence of mild to moderate calcification of the access vessel. Of the 15 patients:
- 10 received a Sapien XT valve, with four getting a 23 mm valve via standard 18-French sheaths and six a 26 mm valve (four with standard 19-French sheaths and two with 18-French E-sheaths); and
- Five received the CoreValve 29 mm valve using 18-French introducers.
They achieved procedural success in all 15 patients. There were no deaths, MIs or strokes. Three patients, all in the Sapien group, experienced vascular complications: a rupture of the right external iliac, one failure of the Prostar device used in percutaneous closure at the left femoral access site, and one pseudoaneurysm of the right femoral artery.
They performed repairs solely using endovascular interventions. All patients were independently ambulatory at discharge and none needed peripheral intervention at 30-days after the procedure.
“Our center experience shows that our modified ‘crossover technique’ for vascular access closure is a safe strategy in patients undergoing TAV[R] for severe symptomatic AS [aortic stenosis],” Buchanan et al wrote. “Our three vascular complications, throughout the very early experience, were able to be repaired rapidly by the interventionalist. In these cases, the use of this technique was instrumental in preventing severe bleeding.”
Their technique gives a physician direct visualization of the puncture site and allows him or her to advance the over-the-wire balloon to obstruct blood flow if there is evidence of bleeding, iliac rupture or pseudoaneurysm. The approach allows the physician to secure hemostasis and then develop a strategy to repair the artery, they proposed.
“The use of our ‘modified crossover technique’ means that iliac or femoral rupture can be effectively managed without immediate hemodynamic collapse,” they wrote. They encouraged TAVR physicians to adopt the technique, but added that their results were preliminary and needed to be supported by results involving more patients.
In an accompanying editorial, Lowell F. Satler, MD, and Danny Dvir, MD, of MedStar Washington Hospital Center in Washington, D.C., noted that the potential pool of patients who might benefit from TAVR is expanding and techniques for managing complications in subsets of these patients will be important for successful outcomes.
“Although, this alternative method may not completely replace the conventional ‘crossover’ technique; radial artery delivery of the crossover iliac balloon could be considered in specific scenarios, particularly in patients with extensive disease of the contralateral ileofemoral system,” Satler and Dvir suggested.