Comparison of 2-Year Outcomes of Extended Criteria Cardiac Transplantation Versus Destination Left Ventricular Assist Device Therapy Using Continuous Flow Mani A. Daneshmand, MDa, Arun Krishnamoorthy, MDb,c,*, Marc D. Samsky, MDb, G. Michael Felker, MD, MHSb,c, John A. Pura, MPHc, Yuliya Lokhnygina, PhDc, Adrian F. Hernandez, MD, MHSb,c, Paul B. Rosenberg, MDb, Laura J. Blue, NPb, Jacob N. Schroder, MDa, Joseph G. Rogers, MDb,c, Carmelo A. Milano, MDa, and Chetan B. Patel, MDb,c Alternatives have emerged for patients ineligible for cardiac transplantation under standard criteria. The purpose of our study was to compare outcomes in patients ineligible for cardiac transplantation under standard criteria, treated either with extended criteria cardiac transplantation (ECCT) or a continuous flow destination therapy left ventricular assist device (CF DT-LVAD). From 2005 to 2012, patients treated with either ECCT or CF DTLVAD at our institution were retrospectively analyzed. In the overall unmatched cohort, we examined mortality and other outcomes, including index hospitalization length of stay, renal function, stroke, and readmission rates. After propensity score (PS) matching, outcomes were compared between ECCT and CF DT-LVAD recipients. Overall, 62 patients underwent ECCT, and 146 patients were treated with CF DT-LVAD. The 2-year mortality estimate for ECCT recipients was 27.3% (95% confidence interval 15.5% to 39.1%) and for CF DT-LVAD recipients was 11.2% (95% confidence interval 4.8% to 17.6%). After PS matching of 39 patients from each treatment group, there was no significant difference in overall survival after 2 years (p [ 0.346). In both unmatched and PS-matched analyses, CF DT-LVAD patients compared with ECCT had a significantly higher estimated glomerular filtration rate at 1 year but also had significantly higher hospital readmission rates. Stroke also more commonly occurred after CF DT-LVAD compared with ECCT (17 vs 5, unmatched; and 2 vs 1, PS matched). However, there was no significant difference between PS-matched groups in 2-year stroke-free survival (p [ 0.371). In conclusion, ECCT and CF DT-LVAD in select patients are comparable therapies with respect to 2-year survival. Ó 2015 Elsevier Inc. All rights reserved. (Am J Cardiol 2015;116:573e579) For patients with heart failure (HF) with symptoms refractory to maximal medical therapy (advanced or end-stage HF), cardiac transplantation under standard criteria (SCCT) is currently considered the most reliable therapy.1 However, SCCT is limited both by suitable donor availability and selective recipient characteristics.2 Alternative therapies have emerged for patients ineligible for SCCT. Extended criteria cardiac transplantation (ECCT) matches marginal donor organs that would otherwise go unused with recipients who have co-morbidities that would typically exclude them from SCCT.3,4 Another therapeutic option is mechanical circulatory support with a left ventricular assist device (LVAD) as destination therapy (DT). Since the advent of continuous flow (CF) devices, LVAD therapy has shown increasing reductions in morbidity and mortality for a Department of Surgery, bDepartment of Medicine, and cDuke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina. Manuscript received February 25, 2015; revised manuscript received and accepted May 7, 2015. Drs. Daneshmand and Krishnamoorthy contributed equally to the manuscript. See page 578 for disclosure information. *Corresponding author: Tel: (919) 681-3398; fax: (919) 668-7078. E-mail address: [email protected] (A. Krishnamoorthy).

0002-9149/15/$ - see front matter Ó 2015 Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.amjcard.2015.05.016

the patient with end-stage HF.5e7 Comparison of outcomes after ECCT and DT-LVAD has not been performed though since approval of CF devices for DT.8 Thus, there is limited information to provide patients who could be considered eligible for either therapy. Given our present experience with ECCT and the improved outcomes with CF devices, we hypothesized that the survival of patients ineligible for SCCT are similar with either ECCT or CF DT-LVAD.9 Additionally, we examined nonsurvival outcomes because of the unique differences in postoperative complications between ECCT and CF DT-LVAD.10 Methods We retrospectively evaluated patients with end-stage HF deemed ineligible for SCCT who underwent either ECCT or CF DT-LVAD from January 1, 2005, to December 31, 2012, at Duke University Medical Center. Determination of which therapy a patient received was dependent on patient and physician preference. No prospective protocol dictated their subsequent treatment. An extended-criteria protocol was developed and initiated at our center in January 2000.4 Patients were considered for ECCT if they were aged
65 years or they had significant co-morbidities including significant renal insufficiency, peripheral arterial disease (including carotid www.ajconline.org

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Table 1 Baseline characteristics in the overall unmatched cohort, stratified by extended criteria cardiac transplantation versus continuous flow destination therapy left ventricular assist device recipients Variable

Extended criteria cardiac transplantation (n ¼ 62)

Continuous flow destination therapy left ventricular assist device (n ¼ 146)

68 [66, 70] 48 (77%) 13 (21%) 37 (60%) 20 [15, 25] 6.3 [5.6, 7.0] 1.3 [1.1, 1.6] 54 [43, 74] 26 [20, 37] 0.9 [0.6, 1.3] 3.5 [3.1, 3.9] 1.4 [1.1, 1.7] 19 (36%) 2.1 [1.8, 2.5] 2.8 [1.8, 3.9] 55 [48, 61]

67 [59, 73] 108 (74%) 41 (28%) 91 (62%) 17 [10, 20] 6.7 [6.1, 7.3] 1.5 [1.1, 2.0] 48 [34, 70] 30 [20, 45] 1.3 [0.9, 2.0] 3.1 [2.6, 3.5] 1.2 [1.1, 1.3] 53 (44%) 1.8 [1.5, 2.2] 3.3 [2.1, 4.2] 51 [44, 57]

Age (years) Male Black Ischemic cardiomyopathy Left ventricular ejection fraction (%; n ¼ 199) Left ventricular end-diastolic dimension (cm, n ¼ 183) Serum creatinine (mg/dL) Estimated glomerular filtration rate (mL/min/1.73 m2) Blood urea nitrogen (mg/dL) Total bilirubin (g/dL) Albumin (g/dL; n ¼ 200) International normalized ratio Pre-procedure inotrope (n ¼ 174) Cardiac index (L/min/m2; n ¼ 179) Pulmonary vascular resistance (Wood units; n ¼ 174) Mixed venous oxygen saturation (%; n ¼ 177)

P value