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Clinical Outcome and Quality of Life with an Ambulatory Counterpulsation Pump (iVAS) in Advanced Heart Failure Patients
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Journal of Cardiac Failure Vol. 24 No. 11 November 2018
Clinical Outcome and Quality of Life with an Ambulatory Counterpulsation Pump (iVAS) in Advanced Heart Failure Patients D1XV. X JEEVANANDAMD2X1X , D. D3X X ONSAGERD14X X , T. D5X X SONGD16X X , T. D7X X OTAD18X X , C. D9X X JURICEKD10X1X , P. D1X X COMBSD12X1X , T. D13X X LAMMYD114X X , G. D15X X KIMD16X2X , D17XS. X PATEL-RAMAND18X3X , G. D19X X SAYERD20X2X , N. D21X X URIELD2X2X ; 1 2 CT Surgery, University of Chicago, Chicago, IL; Cardiology, University of Chicago, Chicago, IL; 3NuPulseCV, Raleigh, NC Purpose: The NuPulseCV intravascular ventricular assist system (iVAS) provides extended duration ambulatory counterpulsation and can be used for subacute or chronic cardiac support. The pump consists of a durable 50cc counterpulsation pump placed through the subclavian artery, and a transcutaneous electromechanical conduit for air and electrocardiographic data transmission. Previously, we reported on the First in Human (FIH) experience of the iVAS in 14 patients, focusing on the implantation technique, outcomes and complications. Hereby, we are reporting the results of the iVAS feasibility study in advanced heart failure (aCHF) patients. Methods: This is a prospective, non-randomized single arm trial of iVAS implantation in aCHF
patients eligible for cardiac transplantation. The primary endpoint was transplant or survival at 30 days; secondary endpoints include procedural success, adverse events, exercise performance and quality of life during device support. Results: Forty-six patients were enrolled and 44 received iVAS. There were 36 males; mean age 58.9§ 7.7 years; cardiomyopathy ischemic 21 and non-ischemic 23; 98% were NYHA 3-4; 98% were INTERMACS 2-4; LVEF 23.6§10.7. 88.6% of patients successfully achieved the primary endpoint. Six minute walk improved by 23% from 1011§300 to 1234§360 2-4 weeks after implant. Kansas City Cardiomyopathy scores improved from 49 to 61. 16 patients were discharged home with iVAS support. Conclusions: In this feasibility trial, using iVAS in aCHF patients eligible for heart transplantation, we demonstrated high rate of achieving the primary endpoint success with excellent procedural success and significant improvement in exercise performance and quality of life parameters. These data, along with those from a current trial enrolling a wider range of aCHF patients regardless of transplant eligibility, will be used to support initiation of a pivotal study.
Journal of Cardiac Failure Vol. 24 No. 11 November 2018
Clinical Outcome and Quality of Life with an Ambulatory Counterpulsation Pump (iVAS) in Advanced Heart Failure Patients D1XV. X JEEVANANDAMD2X1X , D. D3X X ONSAGERD14X X , T. D5X X SONGD16X X , T. D7X X OTAD18X X , C. D9X X JURICEKD10X1X , P. D1X X COMBSD12X1X , T. D13X X LAMMYD114X X , G. D15X X KIMD16X2X , D17XS. X PATEL-RAMAND18X3X , G. D19X X SAYERD20X2X , N. D21X X URIELD2X2X ; 1 2 CT Surgery, University of Chicago, Chicago, IL; Cardiology, University of Chicago, Chicago, IL; 3NuPulseCV, Raleigh, NC Purpose: The NuPulseCV intravascular ventricular assist system (iVAS) provides extended duration ambulatory counterpulsation and can be used for subacute or chronic cardiac support. The pump consists of a durable 50cc counterpulsation pump placed through the subclavian artery, and a transcutaneous electromechanical conduit for air and electrocardiographic data transmission. Previously, we reported on the First in Human (FIH) experience of the iVAS in 14 patients, focusing on the implantation technique, outcomes and complications. Hereby, we are reporting the results of the iVAS feasibility study in advanced heart failure (aCHF) patients. Methods: This is a prospective, non-randomized single arm trial of iVAS implantation in aCHF
patients eligible for cardiac transplantation. The primary endpoint was transplant or survival at 30 days; secondary endpoints include procedural success, adverse events, exercise performance and quality of life during device support. Results: Forty-six patients were enrolled and 44 received iVAS. There were 36 males; mean age 58.9§ 7.7 years; cardiomyopathy ischemic 21 and non-ischemic 23; 98% were NYHA 3-4; 98% were INTERMACS 2-4; LVEF 23.6§10.7. 88.6% of patients successfully achieved the primary endpoint. Six minute walk improved by 23% from 1011§300 to 1234§360 2-4 weeks after implant. Kansas City Cardiomyopathy scores improved from 49 to 61. 16 patients were discharged home with iVAS support. Conclusions: In this feasibility trial, using iVAS in aCHF patients eligible for heart transplantation, we demonstrated high rate of achieving the primary endpoint success with excellent procedural success and significant improvement in exercise performance and quality of life parameters. These data, along with those from a current trial enrolling a wider range of aCHF patients regardless of transplant eligibility, will be used to support initiation of a pivotal study.