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. Author manuscript; available in PMC: 2019 May 1.
Published in final edited form as: ASAIO J. 2018 May-Jun;64(3):287–294. doi: 10.1097/MAT.0000000000000684

Table 1.

Study Characteristicsa

First Author,
Year
Location Device Study
Design
No. of
Patients
Patient
Age,
Years
%
Men
Race/
Ethnicity
(%)
Indication for
LVAD (%)
Duration of
Support
Inclusion
Criteria
Exclusion Criteria
Miller et al, 200746 Multi-center HeartMate II Prospective, observational 133 50.1 76.0 White (69)
African American (23)
BTT (100)
ICM (37)
126 d, median End-stage heart failure Severe renal, pulmonary, or hepatic dysfunction; active, uncontrolled infection; mechanical aortic valve; aortic insufficiency; other support device (except IABP)
Schulman et al, 200724 New York, USA HeartMate II, DeBakey Micro-Med Retrospective, case series 27 55.1 (12.8) 81.5 NR NR NR Implantation between October 2003 and April 2006 NR
Struber et al, 200816 Hanover, Germany HeartMate II Retrospective, case series 101 48 (13) NR NR BTT (69.3)
DT (30.7)
NR 12 European centers between March 2004 and January 2007 NR
Morshuis et al, 200947 Multi-center DuraHeart Prospective, observational 33 55.5 (12.5) 85.0 NR BTT (100.0) 242 (243) d Surgical contraindication to LVAD, high-risk cardiothoracic surgery within 30 days, aortic regurgitation, severe COPD, >1 week of ventilator support, active infection, end- stage renal or liver disease, primary RV dysfunction NR
Lahpor et al, 201048 Multi-center HeartMate II Registry review 411 51.0 (14.0) 81.0 NR NR 236 (214) d HeartMate II implanted in 1 of 64 European centers that contribute to the Thoratec data bank Implantation <6 mo before study inception
Topkara et al, 201032 Missouri, USA HeartMate II, Ventr-Assist Retrospective, case series 81 51.8 (13.7) 78.0 White (77) African American (23) DT (29.6)
BTT (70.4)
ICM (46.7)
9.2 (9.2) mo NR NR
Wieselthaler et al, 201049 Multi-center Heart-Ware HVAD Nonrandomized controlled trial 23 48 (12.6) 87.0 NR ICM (30.0) 167 (143) d Refractory end- stage heart failure with optimal medical therapy and inotropes. UNOS status 1A or 1B Mechanical circulatory support (except IABP); cardiac transplant within 12 mo; mortality within 14 days; >72 h mechanical ventilation; PE within 2 weeks; mechanical valve; aortic regurgitation; active, uncontrolled infection; thrombocytopenia; uncontrolled coagulopathy; dialysis; liver failure
Bogaev et al, 201139 Multi-center HeartMate II Secondary analysis of data from Heart-Mate II clinical trial and continuous access protocol 465 51.8 (13.2) 77.6 NR BTT (100.0)
ICM (44.9)
338.9 (335.9) d At least 18 mo follow-up HeartMate II clinical trial
Garbade et al, 201150 Leipzig, Germany HeartMate II or Heart-Ware Retrospective, cohort 49 53 (12) 90.0 NR DT (16.0)
BTT (84.0)
138 (53) d Implantation between 2006 and 2010 NR
John et al, 201125 Minnesota, USA HeartMate II Retrospective, cohort 102 52.6 (12.8) 74.5 NR BTT (100.0) 327 (286) d BTT Exchange for device failure or destination therapy
John et al, 201151 Multi-center HeartMate II Registry study 1982 NR 77.2 NR BTT (100.0) 9.7 mo CF LVAD as BTT, data as reported to INTERMACS and from the original HeartMate II clinical trial NR
Schaffer et al, 201115 Maryland, USA HeartMate II Retrospective, case series 86 49.7, mean 70.9 NR DT (33.7)
BTT (66.3)
NR Implantation between June 2000 and May 2009 NR
Starling et al, 201125 Multi-center HeartMate II Registry review 169 NR 78.0 White (74) African American (17) BTT (100.0) 306 (173) d INTERMACS registry for BTT between April and August 2008 NR
Aggarwal et al, 201220 Illinois, USA HeartMate II Retrospective, cohort 87 62 (12.8) 86.0 White (36)
African American (49)
NR ICM (57.4) 923.5 (567.3) d Consecutive patients, between 2005 and 2009 Episode of transient bacteremia
Brewer et al, 201252 Multi-center HeartMate II Retrospective, HeartMate II BTT and DT trials 896 56.8 (14.1) 76.1 White (71.9)
African American (20.2)
NR NR Enrollment in HeartMate II clinical trials for BTT or DT Exchange from HeartMate XVE to HeartMate II
Bomholt et al, 201153 Copen-hagen, Denmark HeartMate II Retrospective, cohort 31 46 (24–55) 74.0 White (100.0) BTT (81.0)
DT (19.0)
ICM (26.0)
317 (93–595) d Consecutive patients NR
Chamogeorgakis et al, 201227 Ohio, USA HeartMate II Retrospective, case series 135 54 (14) 78.5 NR BTT (40.0)
BTD (39.0)
DT (21.0)
NR NR NR
Donahey et al, 201231 Georgia, USA NR Retrospective, case series 57 NR NR NR NR NR NR NR
Eleuteri et al, 201254 Pennsylvania, USA HeartMate II, Heart-Ware HVAD Retrospective, cohort 97 59 (10) 81.0 NR BTT (33.0)
BTC (21.6)
DT (47.4)
3359 (340) d Implantation between 2006 and 2011 NR
Fleissner et al, 201229 Hanover, Germany Heart-Ware HVAD Retrospective, cohort 81 52 (16.1) 82.7 White (100.0) ICM (45)
NICM (55)
258 (531) d Implantation in 2008, 2009, or 2011 NR
Goldstein et al, 201230 Multi-center NR INTERMACS registry study 2006 NR, although younger age was a risk factor for percutaneous infection NR, although older men were at increased risk for infection NR NR NR Implantation between 6/2006 and 9/2010 NR
Guerrero-Miranda et al, 201255 New Jersey, USA HeartMate II,
DeBakey Micro-Med,
Centri-Mag,
DuraHeart,
Ventr-Assist,
Heart-Ware
Retrospective, cohort 120 NR NR NR NR NR NR NR
Hozayen et al, 201256 Minnesota, USA Heart-Ware, Ventr-Assist, Heart-Mate II Retrospective, cohort 63 57.5 (17.4) 68.2 NR ICM (52.4)
NICM (47.6)
NR NR NR
Kamdar et al, 201557 Multi-center NR Registry study 2900 NR NR NR NR NR All patients entered in INTERMACS registry between 6/2006 and 3/2011 NR
Krabatsch et al, 201258 Berlin, Germany Heart-Ware HVAD Retrospective, case series 142 55.1 (15.9) 82.3 NR NR 206 d, mean follow- up Between 9/2009 and 10/2011 Children, patients with congenital heart disease
Maiani et al, 201259 Multisite, Italy Jarvik 2000 Registry study 65 63.0 (8.0) 89.2 NR DT (95)
ICM (53)
320 d, mean Between 2006 and 2011 NR
Mano et al, 201260 Pittsburgh, USA CF LVAD Retrospective, cohort 78 NR NR NR NR 260 (265) d Between 12/2006 and 6/2011 NR
Menon et al, 201261 Aachen, Germany HeartMate II Retrospective, cohort 40 58.0 (11.0) NR NR DT (22.5)
BTT (62.5)
BTC (15.0)
ICM (72.5)
NR NYHA IIIB or IV heart failure, between 2008 and 2011 NR
Park et al, 201262 Multicenter trial HeartMate II Registry study 281 63.3 (12.6) 76.0 NR DT (100.0)
ICM (24.0)
1.7 y, mean ≥2 y follow-up Prior HeartMate XVE
Popov et al, 201263 Harefield, United Kingdom Heart-Ware HVAD Retrospective, case series 34 51.0 (10.0) 85.3 NR NR 261 (264) d Implantation between 2007 and 2011 NR
Schibilsky et al, 201264 Tubingen, Germany HeartMate II or Ventr-Assist Retrospective, case series 43 55.7 (13.3) 83.7 NR DT (25.6)
BTT (74.4)
NR Implantation between 2006 and 2010 NR
Tarzia et al, 201265 Multicenter, Italy Jarvik 2000 Registry review 65 65, median 89.2 NR ICM (53.0) NR Implantation between 2006 and 2011 NR
Aldeiri et al, 201321 Texas, USA HeartMate II Retrospective, cohort 149 55.5 (13) 75.8 NR ICM (59.0) NR Implantation between 2008 and 2012 NR
Choudhary et al, 201328 New York, USA HeartMate II Prospective, observational cohort 171 54.0 (12.4) 82.0 NR NR NR Implantation between 11/2006 and 1/2013 Death within 3 mo of device explant
Forest et al, 201323 New York, USA NR Retrospective, cohort 105 56 (14) 82.0 NR DT (45.0)
ICM (51.0)
NR Implantation between 2006 and 2012 NR
Haj-Yahia et al, 200766 Minnesota, USA HeartMate II Registry study 115 62 [53–69] 83.0 NR DT (64.0)
BTT (36.0)
NR Survival to discharge, between 2008 and 2011 NR
Lalonde et al, 201367 Toronto, Canada HeartMate II and Heart-Ware HVAD Retrospective, case series 46 50.1 (12.6) 60.8 NR BTT (76.2)
BTC (19.5)
DT (4.3)
ICM (26.1)
NR Implantation between 1/2006 and 4/2012 NR
Nienaber et al, 201336 Minnesota, USA HeartMate II,
Jarvik 2000,
Ventr-Assist
Retrospective, case series 78 56.8 (14.9) 79.0 White (87.0)
African American (7.0)
DT (62.0)
BTT (38.0)
1.5 (1.0) y Implantation between 2005 and 2011 LVAD implanted elsewhere, RVAD
Slaughter et al, 201368 Kentucky, USA Heart-Ware HVAD Prospective, observational 332 52.8 (11.9) 71.1 White (68.7)
African American (25.9)
BTT (100.0)
ICM (36.7)
NR UNOS status 1A or 1B Other mechanical circulatory device (except IABP)
Smedira et al, 201317 Ohio, USA HeartMate II Retrospective, case series 92 53 (14) 78.0 NR DT (22.0)
BTT (78.0)
NR Implantation between 10/2004 and 1/2010 NR
Stulak et al, 201369 Minnesota, USA HeartMate II Retrospective, case series 285 54, mean 51.0 NR DT (41.0)
BTT (39.0)
ICM (53.0)
NR Primary VAD implantation NR
Tong et al, 201326 Ohio, USA HeartMate II Retrospective, case series 254 NR NR NR NR NR Between 2004 and 2012 NR
Wu et al, 201370 Berlin, Germany Heart-Ware HVAD Retrospective, case review 141 51.6 (16.2) 82.5 NR DT (28.4)
BTT (71.6)
ICM (44.7)
NR Between 8/2009 and 4/2011 NR
Baronetto et al, 201440 Turin, Italy Heart-Ware HVAD Prospective, observational cohort 23 57.5 100.0 White (100.0) BTT (52.0)
DT (48.0)
7 mo Implant with HeartWare HVAD between 4/2013 and 11/2013 NR
Cagliostro et al, 201441 New York, USA HeartMate II (other devices unspecified) Prospective, observational cohort 253 NR NR NR NR NR Implantation between 2010 and 2013 NR
Chan et al, 201471 Singapore, Singapore HeartMate II or Heart-Ware HVAD Retrospective, cohort 40 41.0 NR NR NR NR Implantation between 5/2009 and 9/2013 NR
Cogswell et al, 201472 Minnesota, USA HeartMate II or Heart-Ware HVAD Matched cohort 60 43 (14.6) 80.0 White (73.3)
African American (16.6)
Asian (1.6)
BTT (95.0)
DT (5.0)
ICM (30.0)
NR Age >16 y; DSM, IV substance abuse (case arm) or documented lack thereof (matched cohort) Death in hospital, contraindications to transplantation
Dean et al, 201473 Multicenter HeartMate II Secondary analysis of Heart-Mate II destination therapy clinical trial 401 60, median NR NR BTT (50.0)
DT (50.0)
19 (7–46) mo Inclusion in HeartMate II registry database NR
Hieda et al, 201474 Osaka, Japan NR Retrospective, case series 16 37.5 (11.9) 100.0 Asian (100.0) BTT (100.0)
ICM (18.8)
387 (228) d BTT, between 2011 and 2013 NR
Jennings et al, 201475 Detroit, USA NR Retrospective, case series 16 52, median 69.0 NR DT (69.0)
BTT (31.0)
NR Between 1/2008 and 8/2011, with systemic antimicrobial agent therapy for suppression of confirmed LVAD infection Superficial percutaneous driveline infection
John et al, 201476 Multicenter Heart-Ware HVAD Registry study 332 52.7 (11.9) 71.1 NR BTT (100.0)
ICM (36.7)
NR Secondary analysis of ADVANCE BTT and CAP trial with ≥6 mo follow-up NR
Jorde et al, 201477 Multi-center HeartMate II Registry study 380 NR 81.8 White (74.5)
African American (18.7)
BTT (65.0)
DT (35.0)
ICM (60.0)
NR First 247 patients who had a HeartMate II implant after FDA device approval and 133 patients in the original HeartMate II clinical trial NR
Kimura et al, 201433 Tokyo, Japan DuraHeart Evaheart Retrospective, case series 31 39.7 (11.7) 84.0 NR BTT (100.0)
ICM (12.9)
NR End-stage heart failure, BTT HeartMate II device implantation
Koval et al, 201478 Ohio, USA HeartMate II Retrospective, case series 181 54 (13.8) 80.0 White (79.0)
Other races unspecified
DT (29)
BTT (71)
ICM (46)
NR Implantation between 10/2004 and 9/2011 Previous LVAD
Kretlow et al, 201414 Texas, USA CF LVAD Retrospective, case series 26 51.3 (15.7) 81.0 NR DT (7.7)
BTT (92.3)
NR All patients treated by the senior author for LVAD infection NR
Masood et al, 201437 Michigan, USA CF LVAD Retrospective, case series 328 56, median 77.0 NR NR NR NR NR
Moazami et al, 201479 Multicenter DuraHeart Prospective, observational study 63 54 (11.3) 84.0 NR BTT (100.0)
ICM (49.0)
NR Advanced heart failure in patients listed for transplant at 1 of 40 investigator centers NR
Nelson et al, 201480 Pennsylvania, USA HeartMate II and Heart-Ware HVAD Retrospective, case series 12 54.3 (19.3) 75.0 White (86.0) African American (14.0) DT (42.0)
BTT (58.0)
ICM (58.0)
DCM (17.0)
NICM (17.0)
Familial (8.0)
NR Patients who required plastic surgery for complex wound management, between 2008 and 2013 NR
Nishi et al, 201481 Osaka, Japan Heart-Ware HVAD Prospective, cohort 9 33.5 (7.8) 66.7 NR BTT (100.0)
ICM (0)
245 (162) d Patients eligible for cardiac transplantation, taking maximal medical therapy NR
Raymer et al, 201482 Missouri, USA HeartMate II Heart-Ware HVAD (35) Retrospective case series 316 NR 78.0 NR NR NR Implantation between 6/2005 and 7/2013 NR
Sabashnikov et al, 20148 Harefield, United Kingdom HeartMate II or Heart-Ware HVAD Retrospective, cohort 139 44 (13.7) NR NR BTT (100.0)
ICM (11.0)
DCM (83.0)
PPM (1.0)
HCM (5.0)
514 (481) d Implantation between 2007 and 2013 NR
Singh et al, 201483 Wisconsin, USA HeartMate II Retrospective, case series 125 NR NR NR NR 628
(231.1) d
Implantation between 6/2008, and 10/2011 NR
Subbotina et al, 201484 Hamburg, Germany Heart-Ware HVAD Retrospective, case series 38 57 (12) NR NR ICM 31.6 10 (7) mo Implantation between 1/2010 and 8/2013 NR
Takeda et al, 201485 New York, USA HeartMate II, Ventr-Assist, Dura-Heart, DeBakey Micro-Med Retrospective, case series 140 54.7 (14.4) 79.3 ICM (36.4) DT (17.9)
BTT (82.1)
NR Implantation between 2004 and 2010 NR
Abou el ela et al, 201586 Missouri, USA HeartMate II and Heart-Ware HVAD Retrospective, case series 363 NR NR NR NR NR Implantation between 2009 and 2013 NR
Akhter et al, 201534 Wisconsin, USA HeartMate II (120) Heart-Ware HVAD (1) DeBakey Micro-Med (1) Retrospective, case series 122 53 (12.9) 77.0 NR ICM (43.6) 370 (336) d Implantation between 2007 and 2013 NR
Birks et al, 201587 Multicenter Heart-Ware HVAD Registry study 332 52.7 (11.9) 71.1 White (68.7)
African American (26.7)
BTT (100)
ICM (36.7)
NR Secondary analysis of ADVANCE BTT and CAP trial, ≥6 mo follow-up NR
Fried et al, 201511 New York, USA HeartMate II, Heart-Ware HVAD Retrospective, case series 298 NR NR NR NR NR Implantation between 2008 and 2014 NR
Fudim et al, 201588 Tennessee, USA Heart-Ware HVAD, Heart-Mate II Retrospective, case series 161 NR NR NR NR NR Implantation between 2009 and 2014 NR
Haeck et al, 201589 Leiden, Netherlands Heart-Ware HVAD Retrospective, case series 16 61 (8) 81.0 NR DT (100.0)
ICM (81.0)
NR Consecutive LVAD implants NR
Haglund et al, 201545 Tennessee, USA HeartMate II, Heart-Ware HVAD Registry study 81 52.6 (10.6) 78.0 NR BTT (100.0) NR Patients in the Vanderbilt Advanced Heart Failure Registry DT, died before the index hospitalization, implantation with temporary or pulsatile LVAD, RVAD, or TAH
Harvey et al, 201590 Minnesota, USA HeartMate II Retrospective, cohort 230 57.0 (14.0) 80.4 NR BTT (80.4)
DT (19.6)
NR Implantation between 2006 and 2013 NR
Henderson et al, 201591 Illinois, USA CF LVAD Retrospective, cohort 56 52.4 (12.5) NR NR NR NR Implantation between 2008 and 2014 NR
Imamura et al, 201513 Japan Evaheart, Dura-Heart, HeartMate II,
Jarvik 2000, Heart-Ware HVAD
Retrospective, cohort 57 40.0 (12.0) 79.0 Asian (100.0) BTB (9.0)
ICM (5.0)
421 (325) d NR Driveline infection before first discharge
Krishna-moorthy et al, 201492 North Carolina, USA HeartMate II Retrospective, case series 5 63.0 (12.2) 100.0 NR DT (100.0)
ICM (80.0)
NR CIED lead removal after LVAD implant and ISHLT- defined LVAD infection NR
Lushaj et al, 201593 Wisconsin, USA HeartMate II, Heart-Ware HVAD Retrospective, case series 128 57.8 84.3 NR DT (32.6)
BTT (67.4)
ICM (22.6)
NR
Between 1/2008 and 6/2014 NR
Majure et al, 20159 District of Columbia, USA HeartMate II, Heart-Ware HVAD Retrospective, case series 141 54.6 (13.6) 74.0 African American (61.7)
Other races not specified
DT (36.1)
BTT (63.9)
ICM (35.0)
NR Implantation between 2011 and 2014 Death before discharge
Maltais et al, 201594 Multicenter Heart-Ware HVAD Registry study 382 NR NR NR NR NR Secondary analysis of ADVANCE BTT and CAP trial NR
Matsumoto et al, 201510 Osaka, Japan Evaheart, Heart-Mate II Retrospective, cohort 39 NR NR NR NR NR Implantation between 2007 and 2014 NR
McCandless et al, 201595 Utah, USA HeartMate II Retrospective, cohort 57 56 (14.6) 87.7 NR DT (25.0)
BTT (75.0)
302 (302) d Utah Artificial Heart Program Database, between 2008 and 2012 NR
McMenamy et al, 201596 Sydney, Australia CF LVAD Retrospective, cohort 85 NR NR NR NR NR Implantation between 2010 and 2014 NR
Nishinaka et al, 201518 Japan Evaheart Registry review 108 42.0 (19) NR NR NR NR Advanced heart failure, J-MACS registry NR
Ono et al, 201597 Japan HeartMate II Registry review 104 41.7 76.0 NR BTT (100) 299.2 d J-MACS registry between 2013 and 2014 NR
Potapov et al, 201598 Europe HeartMate II Retrospective, cohort 479 NR NR NR ICM (46.6)
DCM (49.5)
610 (592) d Implant done at 1 of 3 high-volume European centers between 2006 and 2014 NR
Trachtenberg et al, 201422 Texas, USA HeartMate II Retrospective, case series 149 55.4 (13) 76.0 NR ICM (59.1) 642 (531) d Implantation between 2008 and 2012 NR
Tsiouris et al, 201599 Connecticut, USA HeartMate II (136) Heart-Ware HVAD (13) Retrospective, cohort 149 53.7 (12.1) 74.0 White (59.0)
African American (41.0)
BTT (54.3)
DT (45.7)
ICM (37.0)
NICM (63.0)
435.7 (392.2) d Implantation between 2006 and 2013 NR
Van Meeteren et al, 201512 USA NR Registry review 734 57, median 78.6 NR NR NR Hospital in Mechanical Circulatory Support Registry Network, between 2004 and 2014 NR
Wus et al, 2015100 Pennsylvania, USA HeartMate II Retrospective, case series 68 57 (11.4) 80.9 White (60.3)
Other races not specified
NR NR First implant No ICU-intermediate care–discharge pathway, implant at outside hospital, OHT during index hospitalization, never left ICU, had pump exchange
Yoshioka et al, 2014101 Osaka, Japan Jarvik 2000 Retrospective, case series 9 57 (11.0) 77.8 NR DT (22.8)
BTT (77.2)
725 d, median NR NR
Yost et al, 201519 Illinois, USA NR Retrospective, case series 134 58 (13.1) 73.1 NR NR NR Implantation between 2012 and 2014 NR

Abbreviations: ADVANCE, Ventricular Assist Device for the Treatment of Advanced Heart Failure; BTB, bridge to bridge; BTC, bridge to candidacy; BTD, bridge to destination therapy; BTT, bridge to transplant; CAP, continuous-access protocol; CF, continuous flow; CIED, cardiovascular implantable electronic device; COPD, chronic obstructive pulmonary disease; DCM, dilated cardiomyopathy; DSM, Diagnostic and Statistical Manual of Mental Disorders; DT, destination therapy; HCM, hypertrophic cardiomyopathy; IABP, intraaortic balloon pump; ICM, ischemic cardiomyopathy; ICU, intensive care unit; INTERMACS, Interagency Registry for Mechanically Assisted Circulatory Support; ISHLT, International Society for Heart and Lung Transplant; IV, intravenous; J-MACS, Japanese Registry for Mechanically Assisted Circulatory Support; LVAD, left ventricular assist device; NICM, nonischemic cardiomyopathy; NR, not recorded; OHT, orthotopic heart transplant; PE, pulmonary embolus; PPM, peripartum cardiomyopathy; RV, right ventricular; RVAD, right ventricular assist device; TAH, total artificial heart.

a

Data presented as mean (standard deviation) or median (interquartile range)