Intrapericardial Left Ventricular Assist Device for Advanced Heart Failure.
Mechanical circulatory support with a left ventricular assist device (LVAD) is an established treatment for patients with advanced heart failure. We compared a newer LVAD design (a small intrapericardial centrifugal-flow device) against existing technology (a commercially available axial-flow device) in patients with advanced heart failure who were ineligible for heart transplantation.



We conducted a multicenter randomized trial involving 446 patients who were assigned, in a 2:1 ratio, to the study (centrifugal-flow) device or the control (axial-flow) device. Adults who met contemporary criteria for LVAD implantation for permanent use were eligible to participate in the trial. The primary end point was survival at 2 years free from disabling stroke or device removal for malfunction or failure. The trial was powered to show noninferiority with a margin of 15 percentage points.



The intention-to treat-population included 297 participants assigned to the study device and 148 participants assigned to the control device. The primary end point was achieved in 164 patients in the study group and 85 patients in the control group. The analysis of the primary end point showed noninferiority of the study device relative to the control device (estimated success rates, 55.4% and 59.1%, respectively, calculated by the Weibull model; absolute difference, 3.7 percentage points; 95% upper confidence limit, 12.56 percentage points; P=0.01 for noninferiority). More patients in the control group than in the study group had device malfunction or device failure requiring replacement (16.2% vs. 8.8%), and more patients in the study group had strokes (29.7% vs. 12.1%). Quality of life and functional capacity improved to a similar degree in the two groups.



In this trial involving patients with advanced heart failure who were ineligible for heart transplantation, a small, intrapericardial, centrifugal-flow LVAD was found to be noninferior to an axial-flow LVAD with respect to survival free from disabling stroke or device removal for malfunction or failure. (Funded by HeartWare; ENDURANCE ClinicalTrials.gov number, NCT01166347 .).
From Duke University School of Medicine, Durham, NC (J.G.R., C.A.M.); University of Michigan, Ann Arbor (F.D.P., K.D.A.); Advocate Christ Medical Center, Oak Lawn (A.J.T., G.B.), and University of Chicago Medicine (V.J.) and Northwestern Memorial Hospital (A.S.A.), Chicago - all in Illinois; University of Louisville, Louisville, KY (M.S.S., E.J.B.); MedStar Heart Institute, Washington, DC (S.W.B., S.S.N.); University of Texas Health Science Center (I.D.G.) and Texas Heart Institute (H.M., O.H.F.), Houston; and HeartWare, Framingham, MA (K.L.).
Joseph G
JG
Rogers
From Duke University School of Medicine, Durham, NC (J.G.R., C.A.M.); University of Michigan, Ann Arbor (F.D.P., K.D.A.); Advocate Christ Medical Center, Oak Lawn (A.J.T., G.B.), and University of Chicago Medicine (V.J.) and Northwestern Memorial Hospital (A.S.A.), Chicago - all in Illinois; University of Louisville, Louisville, KY (M.S.S., E.J.B.); MedStar Heart Institute, Washington, DC (S.W.B., S.S.N.); University of Texas Health Science Center (I.D.G.) and Texas Heart Institute (H.M., O.H.F.), Houston; and HeartWare, Framingham, MA (K.L.).
Francis D
FD
Pagani
From Duke University School of Medicine, Durham, NC (J.G.R., C.A.M.); University of Michigan, Ann Arbor (F.D.P., K.D.A.); Advocate Christ Medical Center, Oak Lawn (A.J.T., G.B.), and University of Chicago Medicine (V.J.) and Northwestern Memorial Hospital (A.S.A.), Chicago - all in Illinois; University of Louisville, Louisville, KY (M.S.S., E.J.B.); MedStar Heart Institute, Washington, DC (S.W.B., S.S.N.); University of Texas Health Science Center (I.D.G.) and Texas Heart Institute (H.M., O.H.F.), Houston; and HeartWare, Framingham, MA (K.L.).
Antone J
AJ
Tatooles
From Duke University School of Medicine, Durham, NC (J.G.R., C.A.M.); University of Michigan, Ann Arbor (F.D.P., K.D.A.); Advocate Christ Medical Center, Oak Lawn (A.J.T., G.B.), and University of Chicago Medicine (V.J.) and Northwestern Memorial Hospital (A.S.A.), Chicago - all in Illinois; University of Louisville, Louisville, KY (M.S.S., E.J.B.); MedStar Heart Institute, Washington, DC (S.W.B., S.S.N.); University of Texas Health Science Center (I.D.G.) and Texas Heart Institute (H.M., O.H.F.), Houston; and HeartWare, Framingham, MA (K.L.).
Geetha
G
Bhat
From Duke University School of Medicine, Durham, NC (J.G.R., C.A.M.); University of Michigan, Ann Arbor (F.D.P., K.D.A.); Advocate Christ Medical Center, Oak Lawn (A.J.T., G.B.), and University of Chicago Medicine (V.J.) and Northwestern Memorial Hospital (A.S.A.), Chicago - all in Illinois; University of Louisville, Louisville, KY (M.S.S., E.J.B.); MedStar Heart Institute, Washington, DC (S.W.B., S.S.N.); University of Texas Health Science Center (I.D.G.) and Texas Heart Institute (H.M., O.H.F.), Houston; and HeartWare, Framingham, MA (K.L.).
Mark S
MS
Slaughter
From Duke University School of Medicine, Durham, NC (J.G.R., C.A.M.); University of Michigan, Ann Arbor (F.D.P., K.D.A.); Advocate Christ Medical Center, Oak Lawn (A.J.T., G.B.), and University of Chicago Medicine (V.J.) and Northwestern Memorial Hospital (A.S.A.), Chicago - all in Illinois; University of Louisville, Louisville, KY (M.S.S., E.J.B.); MedStar Heart Institute, Washington, DC (S.W.B., S.S.N.); University of Texas Health Science Center (I.D.G.) and Texas Heart Institute (H.M., O.H.F.), Houston; and HeartWare, Framingham, MA (K.L.).
Emma J
EJ
Birks
From Duke University School of Medicine, Durham, NC (J.G.R., C.A.M.); University of Michigan, Ann Arbor (F.D.P., K.D.A.); Advocate Christ Medical Center, Oak Lawn (A.J.T., G.B.), and University of Chicago Medicine (V.J.) and Northwestern Memorial Hospital (A.S.A.), Chicago - all in Illinois; University of Louisville, Louisville, KY (M.S.S., E.J.B.); MedStar Heart Institute, Washington, DC (S.W.B., S.S.N.); University of Texas Health Science Center (I.D.G.) and Texas Heart Institute (H.M., O.H.F.), Houston; and HeartWare, Framingham, MA (K.L.).
Steven W
SW
Boyce
From Duke University School of Medicine, Durham, NC (J.G.R., C.A.M.); University of Michigan, Ann Arbor (F.D.P., K.D.A.); Advocate Christ Medical Center, Oak Lawn (A.J.T., G.B.), and University of Chicago Medicine (V.J.) and Northwestern Memorial Hospital (A.S.A.), Chicago - all in Illinois; University of Louisville, Louisville, KY (M.S.S., E.J.B.); MedStar Heart Institute, Washington, DC (S.W.B., S.S.N.); University of Texas Health Science Center (I.D.G.) and Texas Heart Institute (H.M., O.H.F.), Houston; and HeartWare, Framingham, MA (K.L.).
Samer S
SS
Najjar
From Duke University School of Medicine, Durham, NC (J.G.R., C.A.M.); University of Michigan, Ann Arbor (F.D.P., K.D.A.); Advocate Christ Medical Center, Oak Lawn (A.J.T., G.B.), and University of Chicago Medicine (V.J.) and Northwestern Memorial Hospital (A.S.A.), Chicago - all in Illinois; University of Louisville, Louisville, KY (M.S.S., E.J.B.); MedStar Heart Institute, Washington, DC (S.W.B., S.S.N.); University of Texas Health Science Center (I.D.G.) and Texas Heart Institute (H.M., O.H.F.), Houston; and HeartWare, Framingham, MA (K.L.).
Valluvan
V
Jeevanandam
From Duke University School of Medicine, Durham, NC (J.G.R., C.A.M.); University of Michigan, Ann Arbor (F.D.P., K.D.A.); Advocate Christ Medical Center, Oak Lawn (A.J.T., G.B.), and University of Chicago Medicine (V.J.) and Northwestern Memorial Hospital (A.S.A.), Chicago - all in Illinois; University of Louisville, Louisville, KY (M.S.S., E.J.B.); MedStar Heart Institute, Washington, DC (S.W.B., S.S.N.); University of Texas Health Science Center (I.D.G.) and Texas Heart Institute (H.M., O.H.F.), Houston; and HeartWare, Framingham, MA (K.L.).
Allen S
AS
Anderson
From Duke University School of Medicine, Durham, NC (J.G.R., C.A.M.); University of Michigan, Ann Arbor (F.D.P., K.D.A.); Advocate Christ Medical Center, Oak Lawn (A.J.T., G.B.), and University of Chicago Medicine (V.J.) and Northwestern Memorial Hospital (A.S.A.), Chicago - all in Illinois; University of Louisville, Louisville, KY (M.S.S., E.J.B.); MedStar Heart Institute, Washington, DC (S.W.B., S.S.N.); University of Texas Health Science Center (I.D.G.) and Texas Heart Institute (H.M., O.H.F.), Houston; and HeartWare, Framingham, MA (K.L.).
Igor D
ID
Gregoric
From Duke University School of Medicine, Durham, NC (J.G.R., C.A.M.); University of Michigan, Ann Arbor (F.D.P., K.D.A.); Advocate Christ Medical Center, Oak Lawn (A.J.T., G.B.), and University of Chicago Medicine (V.J.) and Northwestern Memorial Hospital (A.S.A.), Chicago - all in Illinois; University of Louisville, Louisville, KY (M.S.S., E.J.B.); MedStar Heart Institute, Washington, DC (S.W.B., S.S.N.); University of Texas Health Science Center (I.D.G.) and Texas Heart Institute (H.M., O.H.F.), Houston; and HeartWare, Framingham, MA (K.L.).
Hari
H
Mallidi
From Duke University School of Medicine, Durham, NC (J.G.R., C.A.M.); University of Michigan, Ann Arbor (F.D.P., K.D.A.); Advocate Christ Medical Center, Oak Lawn (A.J.T., G.B.), and University of Chicago Medicine (V.J.) and Northwestern Memorial Hospital (A.S.A.), Chicago - all in Illinois; University of Louisville, Louisville, KY (M.S.S., E.J.B.); MedStar Heart Institute, Washington, DC (S.W.B., S.S.N.); University of Texas Health Science Center (I.D.G.) and Texas Heart Institute (H.M., O.H.F.), Houston; and HeartWare, Framingham, MA (K.L.).
Katrin
K
Leadley
From Duke University School of Medicine, Durham, NC (J.G.R., C.A.M.); University of Michigan, Ann Arbor (F.D.P., K.D.A.); Advocate Christ Medical Center, Oak Lawn (A.J.T., G.B.), and University of Chicago Medicine (V.J.) and Northwestern Memorial Hospital (A.S.A.), Chicago - all in Illinois; University of Louisville, Louisville, KY (M.S.S., E.J.B.); MedStar Heart Institute, Washington, DC (S.W.B., S.S.N.); University of Texas Health Science Center (I.D.G.) and Texas Heart Institute (H.M., O.H.F.), Houston; and HeartWare, Framingham, MA (K.L.).
Keith D
KD
Aaronson
From Duke University School of Medicine, Durham, NC (J.G.R., C.A.M.); University of Michigan, Ann Arbor (F.D.P., K.D.A.); Advocate Christ Medical Center, Oak Lawn (A.J.T., G.B.), and University of Chicago Medicine (V.J.) and Northwestern Memorial Hospital (A.S.A.), Chicago - all in Illinois; University of Louisville, Louisville, KY (M.S.S., E.J.B.); MedStar Heart Institute, Washington, DC (S.W.B., S.S.N.); University of Texas Health Science Center (I.D.G.) and Texas Heart Institute (H.M., O.H.F.), Houston; and HeartWare, Framingham, MA (K.L.).
O H
OH
Frazier
From Duke University School of Medicine, Durham, NC (J.G.R., C.A.M.); University of Michigan, Ann Arbor (F.D.P., K.D.A.); Advocate Christ Medical Center, Oak Lawn (A.J.T., G.B.), and University of Chicago Medicine (V.J.) and Northwestern Memorial Hospital (A.S.A.), Chicago - all in Illinois; University of Louisville, Louisville, KY (M.S.S., E.J.B.); MedStar Heart Institute, Washington, DC (S.W.B., S.S.N.); University of Texas Health Science Center (I.D.G.) and Texas Heart Institute (H.M., O.H.F.), Houston; and HeartWare, Framingham, MA (K.L.).
Carmelo A
CA
Milano
D000328:Adult; D000368:Aged; D018572:Disease-Free Survival; D006333:Heart Failure / Q000401:mortality / Q000628:therapy*; D006353:Heart-Assist Devices / Q000009:adverse effects; D006801:Humans; D057194:Intention to Treat Analysis; D053208:Kaplan-Meier Estimate; D008875:Middle Aged; D011474:Prosthesis Design; D011475:Prosthesis Failure; D011788:Quality of Life; D020521:Stroke / Q000209:etiology