Initial experience: The use of novel balloon expandable sheaths with the impella 2.5L catheter during high risk percutaneous coronary intervention

Background: Vascular access remains a challenge in many patients who require ventricular support using the Impella catheter (Abiomed, Inc., Danvers, MA) for high risk percutaneous coronary intervention (PCI). Specifically, limitations of vessel size, calcification and tortuosity may make large bore access difficult. Balloon expandable (BE) sheath technology allows for the insertion of a smaller diameter sheath, which then can be inflated to a larger French size. Entry at a smaller profile is hypothesized to result in less vessel trauma and improved trackability. We report the first clinical use of the SoloPath BE sheath (Terumo Medical Corporation, Sommerset, NJ) in conjunction with the Impella 2.5L catheter for high risk PCI. Methods: Consecutive patients were enrolled presenting for high risk PCI for unprotected left main stenosis or in the setting of a left ventricular ejection fraction <30% requiring left ventricular assist device. Indications for a BE sheath were aorto-iliac tortuosity with diffuse calcification or small common iliac diameter of <7 mm. Ilio-femoral angiography was performed prior to sheath insertion. A PercloseProGlide (Abbott Vascular, Abbott Park, Illinois) closure device was used for hemostasis in 2 cases using a 2 suture “pre-close” technique and 1 underwent pre-planned surgical closure due to a calcified artery. After PCI, the sheath was deflated to ~15Fr and removed. Data on vascular complications was recorded. Results: There were 4 patients (mean Age: 71.5, 3 male, 2 with diabetes, 2 with PAD) requiring Impella support during PCI (2 left main stenosis, 1 LVEF <30%) included. Three patients had aorto-iliac tortuosity and 1 patient had an iliac diameter <7 mm. The BE sheath was inserted with an initial outer diameter of 15 Fr. and was advanced to the common iliac artery. The sheath was inflated at 20 ATM for 60 seconds for an expanded outer diameter of 19 Fr and expanded internal diameter of 16 Fr. Following Impella delivery and PCI, the sheath was removed. No vascular complications occurred during hospitalization. Conclusion: A BE sheath is an alternative to conventional insertion of large bore sheaths for ventricular support devices. Given a smaller initial profile, gradual expansion has a potential for less vascular injury. Further studies are needed to determine if fewer vascular complications occur after use of this novel device. Correspondence to: Anand Prasad, Department of Medicine, University of Texas Health Science Center, San Antonio, USA, Tel: 2146809774; E-mail: [email protected] Received: February 24, 2015; Accepted: March 30, 2015; Published: April 04, 2015 Introduction In recent years, there has been an increase in the use of percutaneous left ventricular assist devices (LVAD) in the context of high-risk percutaneous coronary interventions (PCI). Femoral access remains the route of choice for insertion of these devices; however vessel suitability may be limited by tortuosity and/or the presence of peripheral arterial disease. Specifically, the arterial introduction of large bore devices has been associated with increased rates of dissection, rupture, or occlusion of the ilio-femoral vessels [1]. The use of balloon expandable sheaths has been shown in a handful of case reports to increase access availability, reduce vascular complications, and improve the maneuverability of large devices [2,3]. However, there are no reports detailing the use of balloon expandable sheaths in conjunction with percutaneous LVAD therapy in elective high-risk PCI. The Solopath balloon expandable sheath (Terumo Medical Corporation, Sommerset, NJ) is composed of a folded outer sheath that is pre-mounted over a central balloon dilation catheter. The outer sheath has a hydrophilic coating to facilitate delivery through the femoral artery. Once inserted, the balloon catheter is inflated using a standard inflation device and the folded outer sheath is expanded to achieve its nominal diameter. The embedded stent in the outer sheath maintains luminal patency [4]. In the present report, we describe the safety and feasibility using the Solopath sheath in conjunction with the Impella 2.5L (Abiomed, Inc., Danvers, MA) catheter in elective high-risk PCI. Patients and methods