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Research Article| Volume 26, ISSUE 7, P580-587, July 2020

Predictors of Physical Capacity 6 Months After Implantation of a Full Magnetically Levitated Left Ventricular Assist Device: An Analysis From the ELEVATE Registry

      Abstract

      Background

      In patients with a continuous-flow left ventricular assist device, preimplant predictors of poor physical performance are not well-described. We aimed to identify predictors of inability to walk more than 300 m on 6-minute walk test (6MWT) 6 months after HeartMate 3 implantation.

      Methods and Results

      Using data from the European Registry of Patients Implanted With a Full Magnetically Levitated LVAD, patients with available 6MWT at 6 months after implantation were included (N = 194) and grouped according to 6MWT distance (6MWD) of >300 m (n = 150) or 6MWD of <300 m (n = 44). Patients walking <300 m were older (60 ± 10 vs 52 ± 12 years; P < .001), more often New York Heart Association functional class IV (63% vs 42%; P = .03), and more often had type 2 diabetes (43% vs 17%; P < .001) at implantation. Atrial fibrillation was seen in 57% in those with a 6MWT of <300 m vs 31% in those walking longer (P < .002). Further, hemoglobin and estimated glomerular filtration rate was lower in those walking <300 m (both P < .01). In multivariable regression analysis, independent predictors of a 6MWD of <300 m were: atrial fibrillation (odds ratio [OR], 3.22; 95% confidence interval [CI], 1.12–8.67), older age (OR for 10-year increment, 2.81; 95% CI, 1.55–5.07), New York Heart Association functional class IV (OR, 3.37; 95% CI, 1.27–8.98), and Interagency Registry for Mechanically Assisted Circulatory Support profile 1 or 2 (OR, 6.53; 95% CI, 1.92–22.19).

      Conclusions

      Six months after HeartMate 3 implantation, 77% of patients walked >300 meters in 6 minutes. Apart from age and measures of heart failure severity, atrial fibrillation at implantation is an independent predictor of low 6MWD at 6 months after implantation.

      Key Words

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      References

        • Chatterjee A.
        • Feldmann C.
        • Hanke J.S.
        • Ricklefs M.
        • Shrestha M.
        • Dogan G.
        • et al.
        The momentum of HeartMate 3: a novel active magnetically levitated centrifugal left ventricular assist device (LVAD).
        J Thorac Dis. 2018; 10: S1790-S1793
        • Mehra M.R.
        • Goldstein D.J.
        • Uriel N.
        • Cleveland J.C.
        • Yuzefpolskaya M.
        • Salerno C.
        • et al.
        Two-year outcomes with a magnetically levitated cardiac pump in heart failure.
        N Engl J Med. 2018; 378: 1386-1395
        • Gustafsson F.
        • Shaw S.
        • Lavee J.
        • Saeed D.
        • Pya Y.
        • Krabatsch T.
        • et al.
        Six-month outcomes after treatment of advanced heart failure with a full magnetically levitated continuous flow left ventricular assist device: report from the ELEVATE registry.
        Eur Heart J. 2018; 39: 3454-3460
        • Gustafsson F.
        • Rogers J.G.
        Left ventricular assist device therapy in advanced heart failure: patient selection and outcomes.
        Eur J Heart Fail. 2017; 19: 595-602
        • Schmitto J.D.
        • Hanke J.S.
        • Rojas S.V.
        • Avsar M.
        • Haverich A.
        First implantation in man of a new magnetically levitated left ventricular assist device (HeartMate III).
        J Heart Lung Transplant. 2015; 34: 858-860
        • Rogers J.G.
        • Aaronson K.D.
        • Boyle A.J.
        • Russell S.D.
        • Milano C.A.
        • Pagani F.D.
        • et al.
        Continuous flow left ventricular assist device improves functional capacity and quality of life of advanced heart failure patients.
        J Am Coll Cardiol. 2010; 55: 1826-1834
        • Kirklin J.K.
        • Pagani F.D.
        • Kormos R.L.
        • Stevenson L.W.
        • Blume E.D.
        • Myers S.L.
        • et al.
        Eighth annual INTERMACS report: special focus on framing the impact of adverse events.
        J Hear Lung Transplant. 2017; 36: 1080-1086
        • Grosman-Rimon L.
        • Lalonde S.D.
        • Sieh N.
        • Pakosh M.
        • Rao V.
        • Oh P.
        • et al.
        Exercise rehabilitation in ventricular assist device recipients: a meta-analysis of effects on physiological and clinical outcomes.
        Heart Fail Rev. 2019; 24: 55-67
        • Jung M.H.
        • Gustafsson F.
        Exercise in heart failure patients supported with a left ventricular assist device.
        J Hear Lung Transplant. 2015; 34: 489-496
        • Mirza K.K.
        • Cuomo K.
        • Jung M.H.
        • Russell S.D.
        • Gustafsson F.
        Effect of heart rate reserve on exercise capacity in patients treated with a continuous left ventricular assist device.
        ASAIO J. 2020; 66: 160-165
        • Hasin T.
        • Topilsky Y.
        • Kremers W.K.
        • Boilson B.A.
        • Schirger J.A.
        • Edwards B.S.
        • et al.
        Usefulness of the six-minute walk test after continuous axial flow left ventricular device implantation to predict survival.
        Am J Cardiol. 2012; 110: 1322-1328
        • Starling R.C.
        • Estep J.D.
        • Horstmanshof D.A.
        • Milano C.A.
        • Stehlik J.
        • Shah K.B.
        • et al.
        Risk assessment and comparative effectiveness of left ventricular assist device and medical management in ambulatory heart failure patients: the ROADMAP Study 2-Year Results.
        JACC Heart Fail. 2017; 5: 518-527
        • Cowger J.A.
        • Naka Y.
        • Aaronson K.D.
        • Horstmanshof D.
        • Gulati S.
        • Rinde-Hoffman D.
        • et al.
        Quality of life and functional capacity outcomes in the MOMENTUM 3 trial at 6 months: a call for new metrics for left ventricular assist device patients.
        J Hear Lung Transplant. 2018; 37: 15-24
        • Schmidt T.
        • Bjarnason-Wehrens B.
        • Mommertz S.
        • Hannig M.
        • Schulte-Eistrup S.
        • Willemsen D.
        • et al.
        Changes in total cardiac output and oxygen extraction during exercise in patients supported with an HVAD left ventricular assist device.
        Artif Organs. 2018; 42: 686-694
        • Gustafsson F.
        Management of patients with cardiogenic shock on temporary mechanical circulatory support: urgent transplantation or on to the next pump?.
        Eur J Heart Fail. 2018; 20: 187-189
        • Papathanasiou J.V.
        • Ilieva E.M.
        • Nikolov F.P.
        Exercise training modes in rehabilitation of patients with chronic heart failure.
        Folia Med (Plovdiv). 2012; 54: 22-28
        • Rostagno C.
        • Olivo G.
        • Comeglio M.
        • Boddi V.
        • Banchelli M.
        • Galanti G.
        • et al.
        Prognostic value of 6-minute walk corridor test in patients with mild to moderate heart failure: comparison with other methods of functional evaluation.
        Eur J Heart Fail. 2003; 5: 247-252
        • Cahalin L.P.
        • Mathier M.A.
        • Semigran M.J.
        • Dec G.W.
        • DiSalvo T.G.
        The six-minute walk test predicts peak oxygen uptake and survival in patients with advanced heart failure.
        Chest. 1996; 110: 325-332
        • Roul G.
        • Germain P.
        • Bareiss P.
        Does the 6-minute walk test predict the prognosis in patients with NYHA class II or III chronic heart failure?.
        Am Heart J. 1998; 136: 449-457
        • Mehra M.R.
        • Naka Y.
        • Uriel N.
        • Goldstein D.J.
        • Cleveland J.C.
        • Colombo P.C.
        • et al.
        A fully magnetically levitated circulatory pump for advanced heart failure.
        N Engl J Med. 2017; 376: 440-450
        • Netuka I.
        • Sood P.
        • Pya Y.
        • Zimpfer D.
        • Krabatsch T.
        • Garbade J.
        • et al.
        Fully magnetically levitated left ventricular assist system for treating advanced HF: a multicenter study.
        J Am Coll Cardiol. 2015; 66: 2579-2589
        • Schmitto J.D.
        • Pya Y.
        • Zimpfer D.
        • Krabatsch T.
        • Garbade J.
        • Rao V.
        • et al.
        Long-term evaluation of a fully magnetically levitated circulatory support device for advanced heart failure—two-year results from the HeartMate 3 CE Mark Study.
        Eur J Heart Fail. 2019; 21: 90-97
        • Krabatsch T.
        • Netuka I.
        • Schmitto J.D.
        • Zimpfer D.
        • Garbade J.
        • Rao V.
        • et al.
        Heartmate 3 fully magnetically levitated left ventricular assist device for the treatment of advanced heart failure: 1 year results from the Ce mark trial.
        J Cardiothorac Surg. 2017; 12: 1-8
        • Miller L.W.
        • Pagani F.D.
        • Russell S.D.
        • John R.
        • Boyle A.J.
        • Aaronson K.D.
        • et al.
        Use of a continuous-flow device in patients awaiting heart transplantation.
        N Engl J Med. 2007; 357: 885-896
        • Slaughter M.S.
        • Rogers J.G.
        • Milano C.A.
        • Russell S.D.
        • Conte J.V.
        • Feldman D.
        • et al.
        Advanced heart failure treated with continuous-flow left ventricular assist device.
        N Engl J Med. 2009; 361: 2241-2251
        • Aaronson K.D.
        • Slaughter M.S.
        • Miller L.W.
        • McGee E.C.
        • Cotts W.G.
        • Acker M.A.
        • et al.
        Use of an intrapericardial, continuous-flow, centrifugal pump in patients awaiting heart transplantation.
        Circulation. 2012; 125: 3191-3200
        • Estep J.D.
        • Starling R.C.
        • Horstmanshof D.A.
        • Milano C.A.
        • Selzman C.H.
        • Shah K.B.
        • et al.
        Risk assessment and comparative effectiveness of left ventricular assist device and medical management in ambulatory heart failure patients: results from the ROADMAP Study.
        J Am Coll Cardiol. 2015; 66: 1747-1761
        • Cohn J.N.
        • Johnson G.
        • Ziesche S.
        • Cobb F.
        • Francis G.
        • Tristani F.
        • et al.
        A comparison of enalapril with hydralazine–isosorbide dinitrate in the treatment of chronic congestive heart failure.
        N Engl J Med. 1991; 325: 303-310
        • Lindenfeld J.
        • Feldman A.M.
        • Saxon L.
        • Boehmer J.
        • Carson P.
        • Ghali J.K.
        • et al.
        Effects of cardiac resynchronization therapy with or without a defibrillator on survival and hospitalizations in patients with New York Heart Association class IV heart failure.
        Circulation. 2007; 115: 204-212
        • Brisco M.A.
        • Sundareswaran K.S.
        • Milano C.A.
        • Feldman D.
        • Testani J.M.
        • Ewald G.A.
        • et al.
        The incidence, risk, and consequences of atrial arrhythmias in patients with continuous-flow left ventricular assist devices.
        J Cardiac Surg. 2014; 29: 572-580
        • Rossing K.
        • Jung M.H.
        • Sander K.
        • Olsen P.S.
        • Hansen P.B.
        • Boesgaard S.
        • et al.
        Outcomes and hospital admissions during long-term support with a HeartMate II.
        Scand Cardiovasc J. 2015; 49: 367-375
        • Hickey K.T.
        • Garan H.
        • Mancini D.M.
        • Colombo P.C.
        • Naka Y.
        • Sciacca R.R.
        • et al.
        Atrial fibrillation in patients with left ventricular assist devices: incidence, predictors, and clinical outcomes.
        JACC Clin Electrophysiol. 2016; 2: 793-798
        • Oezpeker C.
        • Zittermann A.
        • Pühler T.
        • Ensminger S.
        • Gummert J.F.
        • Morshuis M.
        Permanent atrial fibrillation and 2 year clinical outcomes in patients with a left ventricular assist device implant.
        ASAIO J. 2017; 63: 419-424
        • Kaye D.M.
        • Silvestry F.E.
        • Gustafsson F.
        • Cleland J.G.
        • van Veldhuisen D.J.
        • Ponikowski P.
        • et al.
        Impact of atrial fibrillation on rest and exercise haemodynamics in heart failure with mid-range and preserved ejection fraction.
        Eur J Heart Fail. 2017; 19: 1690-1697
        • Mirza K.K.
        • Jung M.H.
        • Sigvardsen P.E.
        • Kofoed K.F.
        • Elming M.B.
        • Rossing K.
        • et al.
        Computed tomography–estimated right ventricular function and exercise capacity in patients with continuous-flow left ventricular assist devices.
        ASAIO J. 2020; 66: 8-16