First United States Patient Experience With A New Microaxial, Transvalvular Surgical Mechanical Circulatory Support Device
Danny Ramzy1, Edward Soltesz2, Mark Anderson3.
1Cedars Sinai Medical Center, Los Angeles, CA, USA, 2Cleveland Clinic, Cleveland, OH, USA, 3Hackensack University Medical Center, Hackensack, NJ, USA.
Background: We report the first US experience of a recently approved microaxial surgical heart pump for the treatment of ongoing cardiogenic shock following acute myocardial infarction (AMICGS), postcardiotomy cardiogenic shock (PCCS), cardiomyopathy including peripartum cardiomyopathy, myocarditis and high risk percutaneous coronary intervention (HRPCI). The pump can be delivered minimally invasively through an axillary artery or directly via the ascending aorta. Implantation technique, hemodynamics, and outcome data will be presented. Methods: Thirty-seven patients were treated at three centers. Demographic, procedural, hemodynamic, and outcome data were obtained from retrospective chart review. Device performance was evaluated from both physician case review and device performance log data provided by the device manufacturer. Results: Thirty-eight patients were identified for implantation with a median age of 63 years (range 34 - 77). Thirty-four were implanted via the axillary artery (76% right, 16% Left), and three implanted directly into the aortic root (8%). There was one unsuccessful device insertion due to a restrictive vessel size (< 6mm). Indications for support included cardiomyopathy (47%), AMICGS (27%), pre-op CABG (11%), PCCS (5%), OPCAB (5%), and procedural support during VT ablation and HRPCI (5%). Cumulative case duration was 529 days with a mean per case of 14 days (1 - 53 days). Twenty-three patients (62%) were successfully weaned off device with recovery of native heart function. Three patients (16%) were bridged to another device, one patient expired on support, two patients (5%) withdrew care, and six patients (16%) were on support with an unknown outcome at this time. No occurrence of device related stroke, hemolysis, limb ischemia or mechanical failure were observed. Conclusions: The new micro-axial surgical heart pump demonstrated successful clinical and device performance in providing both full hemodynamic support and ventricular unloading for patients with AMICGS, cardiomyopathy, and high-risk procedures. As a result, nearly two thirds of patients recovered their native heart function and nearly 90% survived to explant. This early post approval experience represents a significant improvement in clinical outcomes compared to the historical data associated with previous acute mechanical devices and supports further investigation.
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