Objectives: 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.
Background: 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.
Methods: 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.
Results: 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%.
Conclusions: 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.