Clinical application of prophylactic percutaneous left ventricular assist device (TandemHeart) in high-risk percutaneous coronary intervention using an arterial preclosure technique: single-center experience.

The objectives of the present study were to evaluate the feasibility and safety of implanting a prophylactic left ventricular (LV) assist device prior to high-risk percutaneous coronary intervention (PCI) and to assess the impact of suturemediated preclosure of the arteriotomy site on minimizing vascular complications. Patients with multivessel disease, left main coronary artery disease (LMCA) or left main equivalent and/or moderate-to-severe LV dysfunction with elevated LV end-diastolic pressure are at increased risk of complications during PCI. The TandemHeart (TH) is a nonpulsatile percutaneous transseptal ventricular assist device (PTVA) that offers vital temporary hemodynamic support during high-risk PCI. Between April 2004 and November 2005, the TH was implanted in 20 patients undergoing high-risk PCI. Eight patients underwent unprotected LMCA stenting, and rotational atherectomy was used in 17 patients. Suture-mediated femoral artery preclosure was performed prior to inserting a large-bore arterial cannula. The TH was successfully implanted in all 20 patients. Mean LV ejection fraction of the study patients was 38 +/- 18%. Time-to-implantation of the TH, duration of hemodynamic support and mean flow of the TH device were 31 +/- 9 minutes, 74 +/- 40 minutes and 2.5 +/- 1.3 L/minute, respectively. At the end of PCI, the TH was removed in all cases and Perclose sutures were deployed in 18/20 (90%) patients. There was only 1 minor vascular complication, and the average length of stay was 2 +/- 1 days. Periprocedural and inhospital mortality was 0%. Implantation of the TH PTVA is safe and feasible in patients undergoing high-risk PCI with excellent hemodynamic support. Application of suture-mediated devices prior to large arteriotomies can significantly reduce the incidence of vascular complications.