Applying Lessons Learned from TAVR Access Route Management to Transvenous Procedures After Large-Caliber Sheath Removal

by Wolfgang Schillinger, University Medical Center of Göttingen, Germany

In the early days of MitraClip (Abbott Vascular, Inc) therapy, a renowned cardiologist, I believe it was Karl-Heinz Kuck, but I do not exactly remember, called MitraClip one of the most complex technologies in interventional cardiology. Thus, when we started MitraClip at the University Medical Center of Göttingen in early 2009 we spent much time in necessary preparations like increasing our skills in echocardiography and transseptal puncture. I have to admit that this absorbed us to such an extent that we did not care that much about groin management. So when we first faced this issue shortly before the first patients were called in for percutaneous mitral valve repair, we were happy to learn about the figure-of-eight suture that had been successfully used by other investigators to achieve hemostasis after removal of large-caliber sheaths from veins. The technique was published later by the group of Ted Feldman. This cost-efficient technique is amazingly efficacious after removal of a sheath that has a caliber of 24 Fr.

However, we later experienced that this suture was potentially challenging in patients with minimal subcutaneous tissue or in cases with simultaneous use of arterial and venous sheaths. The time had come to really think about alternatives when a patient was immediately sent back to us following early transferral after MitraClip – because we had forgotten to remove the figure-of-eight suture.  For persons not familiar with that stitch, its technique is hard to grasp and its appearance conveys the impression of dilettantism. A literature search revealed that several authors have reported the use of different arterial closure systems in veins after removal of sheaths up to 14 Fr. In our own patients, we had very favorable experience with pre-closure of femoral arteries with just one single Proglide (Abbott Vascular) in patients undergoing TAVR with either Edwards Sapien (Edwards Lifesciences, Inc) or CoreValve (Medtronic, Inc). We therefore had the idea to adopt this technique for groin management in patients undergoing MitraClip therapy.

We have then evaluated pre-closure of the femoral vein with Proglide in 72 patients undergoing MitraClip, of whom 42 patients underwent a groin examination with ultrasound 2 days after the procedure. Only 1 patient (1.4%) needed transfusion of packed cells because of bleeding and hematoma in the groin due to Proglide  failure. None of the patients that were examined with ultrasound revealed an arteriovenous fistula or a pseudoaneurysm, a local thrombosis or a local stenosis related to the Proglide device (Figure 1). We could demonstrate that this approach is feasible, safe, and efficacious. Considering  the rapid spread of transvenous technologies for the treatment of structural heart disease, trials with a clear definition of endpoints such as hematoma, bleeding, arteriovenous fistula, infection, or pseudoaneurysm are mandatory to investigate whether the use of closure systems for veins is appropriate to prevent complications.

Figure 1. Typical ultrasound examination of the right femoral vein 2 days after venous access site closure with Proglide following MitraClip therapy (A). Ultrasound examination of the left femoral vein for reasons of comparison (B).





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