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Implementation of an intensified outpatient follow-up protocol improves outcomes in patients with ventricular assist devices

  • Sonja Hamed
  • Bastian Schmack
  • Florian Mueller
  • Philipp Ehlermann
  • Davina Hittmann
  • Arjang Ruhparwar
  • Hugo A. Katus
  • Philip W. Raake
  • Michael M. KreusserEmail author
Original Paper
  • 26 Downloads

Abstract

Background

Ventricular assist devices (VAD) are increasingly used as long-term treatment for advanced heart failure. However, survival after VAD implantation is still unsatisfactory, and no specific outpatient follow-up algorithms have been formally established. Here, we evaluate the effect of an intensified follow-up protocol (IFUP) on survival rates and VAD-associated complications.

Methods and results

This is a retrospective study of 57 patients who received a VAD at our center between February 2013 and December 2017. Inclusion criteria were discharge home after VAD implantation and follow-up in our VAD outpatient clinic. Patients implanted after October 2015 (n = 30) were monitored according to IFUP. This protocol embodied formalized, multi-disciplinary clinical visits every 4–8 weeks including a cardiologist, a cardiothoracic surgeon and a VAD-coordinator and was characterized by optimized anticoagulation and wound management as well as guideline-directed medical therapy. One-year survival in the IFUP patients was 97%, compared to 74% in the pre-IFUP era (p = 0.01). Implementation of IFUP was associated with a 90% risk-reduction for 1-year mortality (relative risk 0.099; p = 0.048). The rate of complications, e.g., device thrombosis and major bleeding, was significantly reduced, resulting in superior event-free survival in the IFUP group (p = 0.003). Furthermore, by implementation of IFUP, a more stable anticoagulation adjustment was achieved as well as an improved adherence to guideline-directed medical therapy.

Conclusion

Implementation of an IFUP for VAD patients is associated with a significant decrease in 1-year all-cause mortality. This emphasizes the need for more vigilance in the management of VAD patients by a dedicated multi-disciplinary team.

Keywords

Advanced heart failure Ventricular assist devices Mechanical circulatory support Outpatient care Follow-up protocol 

Notes

Acknowledgements

We thank Tanja Proctor, M.Sc. (Institute for Medical Biometry and Medical informatics, University of Heidelberg, Heidelberg, Germany) for statistical advice and review.

Funding

None.

Compliance with ethical standards

Conflict of interest

BS and AR received travel grants (for international conferences) and consultancy fees from Berlin Heart. PWR received speaker honoraria from Abbott (Thoratec). MMK received research grants from Abbott (Thoratec) and travel grants (for international conferences) from Medtronic (HeartWare). The other authors report no conflict of interest regarding the content herein.

References

  1. 1.
    Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JGF, Coats AJS, Falk V, González-Juanatey JR, Harjola V-P, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GMC, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P, Group ESCSD (2016) 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failureThe Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC) developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur Heart J 37(27):2129–2200.  https://doi.org/10.1093/eurheartj/ehw128 Google Scholar
  2. 2.
    Yancy CW, Jessup M, Bozkurt B, Butler J, Casey DE Jr, Drazner MH, Fonarow GC, Geraci SA, Horwich T, Januzzi JL, Johnson MR, Kasper EK, Levy WC, Masoudi FA, McBride PE, McMurray JJ, Mitchell JE, Peterson PN, Riegel B, Sam F, Stevenson LW, Tang WH, Tsai EJ, Wilkoff BL, American College of Cardiology F, American Heart Association Task Force on Practice G (2013) 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol 62(16):e147–e239.  https://doi.org/10.1016/j.jacc.2013.05.019 Google Scholar
  3. 3.
    Roth S, Fox H, Fuchs U, Schulz U, Costard-Jackle A, Gummert JF, Horstkotte D, Oldenburg O, Bitter T (2018) Noninvasive pulse contour analysis for determination of cardiac output in patients with chronic heart failure. Clin Res Cardiol 107(5):395–404.  https://doi.org/10.1007/s00392-017-1198-7 Google Scholar
  4. 4.
    Kreusser MM, Tschierschke R, Beckendorf J, Baxmann T, Frankenstein L, Dosch AO, Schultz JH, Giannitsis E, Pleger ST, Ruhparwar A, Karck M, Katus HA, Raake PW (2018) The need for dedicated advanced heart failure units to optimize heart failure care: impact of optimized advanced heart failure unit care on heart transplant outcome in high-risk patients. ESC Heart Fail  https://doi.org/10.1002/ehf2.12314 Google Scholar
  5. 5.
    Bekfani T, Westphal F, Schulze PC (2018) Therapeutic options in advanced heart failure. Clin Res Cardiol  https://doi.org/10.1007/s00392-018-1318-z Google Scholar
  6. 6.
    Benz AP, Vamos M, Erath JW, Bogyi P, Duray GZ, Hohnloser SH (2018) ICD lead type and RV lead position in CRT-D recipients. Clin Res Cardiol 107(12):1122–1130.  https://doi.org/10.1007/s00392-018-1286-3 Google Scholar
  7. 7.
    Poller W, Kaya Z, Muche M, Kasner M, Skurk C, Kappert K, Tauber R, Escher F, Schultheiss HP, Epple HJ, Landmesser U (2017) High incidence of cardiac dysfunction and response to antiviral treatment in patients with chronic hepatitis C virus infection. Clin Res Cardiol 106(7):551–556.  https://doi.org/10.1007/s00392-017-1086-1 Google Scholar
  8. 8.
    Kreusser MM, Geis NA, Berlin N, Greiner S, Pleger ST, Bekeredjian R, Katus HA, Raake PW (2018) Invasive hemodynamics and cardiac biomarkers to predict outcomes after percutaneous edge-to-edge mitral valve repair in patients with severe heart failure. Clin Res Cardiol  https://doi.org/10.1007/s00392-018-1365-5 Google Scholar
  9. 9.
    Takeda K, Takayama H, Kalesan B, Uriel N, Colombo PC, Jorde UP, Naka Y (2014) Long-term outcome of patients on continuous-flow left ventricular assist device support. J Thorac Cardiovasc Surg 148(4):1606–1614.  https://doi.org/10.1016/j.jtcvs.2014.04.009 Google Scholar
  10. 10.
    Mehra MR, Naka Y, Uriel N, Goldstein DJ, Cleveland JC Jr, Colombo PC, Walsh MN, Milano CA, Patel CB, Jorde UP, Pagani FD, Aaronson KD, Dean DA, McCants K, Itoh A, Ewald GA, Horstmanshof D, Long JW, Salerno C, Investigators M (2017) A fully magnetically levitated circulatory pump for advanced heart failure. N Engl J Med 376(5):440–450.  https://doi.org/10.1056/NEJMoa1610426 Google Scholar
  11. 11.
    Schmack B, Weymann A, Ruschitzka F, Autschbach R, Raake PW, Jurrmann N, Menon AK, Karck M, Wilhelm MJ, Ruhparwar A (2018) Successful support of biventricular heart failure patients by new EXCOR® adult pumps with bileaflet valves: a prospective study. Clin Res Cardiol 107(5):413–420.  https://doi.org/10.1007/s00392-017-1200-4 Google Scholar
  12. 12.
    Rose EA, Gelijns AC, Moskowitz AJ, Heitjan DF, Stevenson LW, Dembitsky W, Long JW, Ascheim DD, Tierney AR, Levitan RG, Watson JT, Ronan NS, Shapiro PA, Lazar RM, Miller LW, Gupta L, Frazier OH, Desvigne-Nickens P, Oz MC, Poirier VL, Meier P (2001) Long-term use of a left ventricular assist device for end-stage heart failure. N Engl J Med 345(20):1435–1443.  https://doi.org/10.1056/NEJMoa012175 Google Scholar
  13. 13.
    Slaughter MS, Rogers JG, Milano CA, Russell SD, Conte JV, Feldman D, Sun B, Tatooles AJ, Delgado RM, Long JW, Wozniak TC, Ghumman W, Farrar DJ, Frazier OH (2009) Advanced heart failure treated with continuous-flow left ventricular assist device. N Engl J Med 361(23):2241–2251.  https://doi.org/10.1056/NEJMoa0909938 Google Scholar
  14. 14.
    Mehra MR, Goldstein DJ, Uriel N, Cleveland JC, Yuzefpolskaya M, Salerno C, Walsh MN, Milano CA, Patel CB, Ewald GA, Itoh A, Dean D, Krishnamoorthy A, Cotts WG, Tatooles AJ, Jorde UP, Bruckner BA, Estep JD, Jeevanandam V, Sayer G, Horstmanshof D, Long JW, Gulati S, Skipper ER, O’Connell JB, Heatley G, Sood P, Naka Y (2018) Two-year outcomes with a magnetically levitated cardiac pump in heart failure. N Engl J Med 378(15):1386–1395.  https://doi.org/10.1056/NEJMoa1800866 Google Scholar
  15. 15.
    Saeed O, Jorde UP (2017) Advances in continuous flow left ventricular assist device support for end-stage heart failure: a therapy in evolution. Cardiol Rev 25(2):84–88.  https://doi.org/10.1097/CRD.0000000000000117 Google Scholar
  16. 16.
    Feistritzer HJ, Desch S, de Waha S, Jobs A, Zeymer U, Thiele H (2018) German contribution to development and innovations in the management of acute myocardial infarction and cardiogenic shock. Clin Res Cardiol  https://doi.org/10.1007/s00392-018-1276-5 Google Scholar
  17. 17.
    Kirklin JK, Naftel DC, Pagani FD, Kormos RL, Stevenson LW, Blume ED, Myers SL, Miller MA, Baldwin JT, Young JB (2015) Seventh INTERMACS annual report: 15,000 patients and counting. J Heart Lung Transplant 34(12):1495–1504.  https://doi.org/10.1016/j.healun.2015.10.003 Google Scholar
  18. 18.
    Kirklin JK, Pagani FD, Kormos RL, Stevenson LW, Blume ED, Myers SL, Miller MA, Baldwin JT, Young JB, Naftel DC (2017) Eighth annual INTERMACS report: special focus on framing the impact of adverse events. J Heart Lung Transplant 36(10):1080–1086.  https://doi.org/10.1016/j.healun.2017.07.005 Google Scholar
  19. 19.
    Shah M, Patnaik S, Patel B, Ram P, Garg L, Agarwal M, Agrawal S, Arora S, Patel N, Wald J, Jorde UP (2018) Trends in mechanical circulatory support use and hospital mortality among patients with acute myocardial infarction and non-infarction related cardiogenic shock in the United States. Clin Res Cardiol 107(4):287–303.  https://doi.org/10.1007/s00392-017-1182-2 Google Scholar
  20. 20.
    Kirklin JK, Xie R, Cowger J, de By TMMH, Nakatani T, Schueler S, Taylor R, Lannon J, Mohacsi P, Gummert J, Goldstein D, Caliskan K, Hannan MM (2018) Second annual report from the ISHLT Mechanically Assisted Circulatory Support Registry. J Heart Lung Transplant 37(6):685–691.  https://doi.org/10.1016/j.healun.2018.01.1294 Google Scholar
  21. 21.
    Holman WL, Davies JE, Rayburn BK, McGiffin DC, Foley BA, Benza RL, Bourge RC, Blood P, Kirklin JK (2002) Treatment of end-stage heart disease with outpatient ventricular assist devices. Ann Thorac Surg 73(5):1489–1494.  https://doi.org/10.1016/S0003-4975(02)03502-6 Google Scholar
  22. 22.
    Pamboukian SV, Tallaj JA, Brown RN, Holman WL, Blood M, George JF, Costanzo MR, Cadeiras M, Smallfield MC, McGiffin DC, Kirklin JK (2011) Improvement in 2-year survival for ventricular assist device patients after implementation of an intensive surveillance protocol. J Heart Lung Transplant 30(8):879–887.  https://doi.org/10.1016/j.healun.2011.03.001 Google Scholar
  23. 23.
    Tozzi P, Nowacka A, Hullin R, Yerly P, Kirsch M (2018) The role of heart failure team in managing mechanical circulatory support in a Swiss low-volume institution. Heart Surg Forum 21(4):E257–E262.  https://doi.org/10.1532/hsf.1979 Google Scholar
  24. 24.
    World Medical A (2013) World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. Jama 310(20):2191–2194.  https://doi.org/10.1001/jama.2013.281053 Google Scholar
  25. 25.
    Soliman OII, Akin S, Muslem R, Boersma E, Manintveld OC, Krabatsch T, Gummert JF, de By T, Bogers A, Zijlstra F, Mohacsi P, Caliskan K, Investigators E (2018) Derivation and validation of a novel right-sided heart failure model after implantation of continuous flow left ventricular assist devices: The EUROMACS (European Registry for Patients with Mechanical Circulatory Support) right-sided heart failure risk score. Circulation 137(9):891–906.  https://doi.org/10.1161/CIRCULATIONAHA.117.030543 Google Scholar
  26. 26.
    Garbade J, Gustafsson F, Shaw S, Lavee J, Saeed D, Pya Y, Krabatsch T, Schmitto JD, Morshuis M, Chuang J, Zimpfer D (2018) Postmarket experience with HeartMate 3 left ventricular assist device: 30-day outcomes from the ELEVATE registry. Ann Thorac Surg  https://doi.org/10.1016/j.athoracsur.2018.07.092 Google Scholar
  27. 27.
    Schmack B, Gorenflo M, Rengier F, Ruhparwar A (2013) Extempore interventional closure of a broken CircuLite Synergy micropump inflow graft defect. J Heart Lung transplant 32(11):1140–1141.  https://doi.org/10.1016/j.healun.2013.07.011 Google Scholar
  28. 28.
    Cowger JA, Naka Y, Aaronson KD, Horstmanshof D, Gulati S, Rinde-Hoffman D, Pinney S, Adatya S, Farrar DJ, Jorde UP, Investigators M (2018) 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 Heart Lung Transplant 37(1):15–24.  https://doi.org/10.1016/j.healun.2017.10.019 Google Scholar
  29. 29.
    HeartWare Inc (2012) Heartware ventricular assist system—instructions for use. Miami Lakes. HeartWare Inc, FraminghamGoogle Scholar
  30. 30.
    Thoratec (2017) HeartMate 3 left ventricular assist system instructions for use. Thoratec, PleasantonGoogle Scholar
  31. 31.
    Feldman D, Pamboukian SV, Teuteberg JJ, Birks E, Lietz K, Moore SA, Morgan JA, Arabia F, Bauman ME, Buchholz HW, Deng M, Dickstein ML, El-Banayosy A, Elliot T, Goldstein DJ, Grady KL, Jones K, Hryniewicz K, John R, Kaan A, Kusne S, Loebe M, Massicotte MP, Moazami N, Mohacsi P, Mooney M, Nelson T, Pagani F, Perry W, Potapov EV, Eduardo Rame J, Russell SD, Sorensen EN, Sun B, Strueber M, Mangi AA, Petty MG, Rogers J, Lung T, International Society for H (2013) The 2013 International Society for Heart and Lung Transplantation Guidelines for mechanical circulatory support: executive summary. J Heart Lung Transplant 32(2):157–187.  https://doi.org/10.1016/j.healun.2012.09.013 Google Scholar
  32. 32.
    Teuteberg JJ, Slaughter MS, Rogers JG, McGee EC, Pagani FD, Gordon R, Rame E, Acker M, Kormos RL, Salerno C, Schleeter TP, Goldstein DJ, Shin J, Starling RC, Wozniak T, Malik AS, Silvestry S, Ewald GA, Jorde UP, Naka Y, Birks E, Najarian KB, Hathaway DR, Aaronson KD, Investigators AT (2015) The HVAD left ventricular assist device: risk factors for neurological events and risk mitigation strategies. JACC Heart Fail 3(10):818–828.  https://doi.org/10.1016/j.jchf.2015.05.011 Google Scholar
  33. 33.
    Kataria R, Jorde UP (2019) Gastrointestinal bleeding during continuous-flow left ventricular assist device support: state of the field. Cardiol Rev 27(1):8–13.  https://doi.org/10.1097/CRD.0000000000000212 Google Scholar
  34. 34.
    Bishop MA, Streiff MB, Ensor CR, Tedford RJ, Russell SD, Ross PA (2014) Pharmacist-managed international normalized ratio patient self-testing is associated with increased time in therapeutic range in patients with left ventricular assist devices at an academic medical center. ASAIO J 60(2):193–198.  https://doi.org/10.1097/MAT.0000000000000047 Google Scholar
  35. 35.
    Bloomfield HE, Krause A, Greer N, Taylor BC, MacDonald R, Rutks I, Reddy P, Wilt TJ (2011) Meta-analysis: effect of patient self-testing and self-management of long-term anticoagulation on major clinical outcomes. Ann Intern Med 154(7):472–482.  https://doi.org/10.7326/0003-4819-154-7-201104050-00005 Google Scholar
  36. 36.
    Cagliostro B, Levin AP, Fried J, Stewart S, Parkis G, Mody KP, Garan AR, Topkara V, Takayama H, Naka Y, Jorde UP, Uriel N (2016) Continuous-flow left ventricular assist devices and usefulness of a standardized strategy to reduce drive-line infections. J Heart Lung Transplant 35(1):108–114.  https://doi.org/10.1016/j.healun.2015.06.010 Google Scholar
  37. 37.
    Lietz K, Long J, Kfoury A, Slaughter M, Silver M, Milano C, Rogers J, Naka Y, Mancini D, Miller L (2007) Outcomes of left ventricular assist device implantation as destination therapy in the post-REMATCH era: implications for patient selection. Circulation 116(5):497–505Google Scholar
  38. 38.
    Holman WL, Park SJ, Long JW, Weinberg A, Gupta L, Tierney AR, Adamson RM, Watson JD, Raines EP, Couper GS, Pagani FD, Burton NA, Miller LW, Naka Y (2004) Infection in permanent circulatory support: experience from the REMATCH trial. J Heart Lung Transplant 23(12):1359–1365.  https://doi.org/10.1016/j.healun.2003.09.025 Google Scholar
  39. 39.
    Richenbacher WE, Naka Y, Raines EP, Frazier OH, Couper GS, Pagani FD, Damme L, VanMeter CH, Magovern GJ, Gupta L, Seemuth SC, Weinberg AD, Long JW (2003) Surgical management of patients in the REMATCH trial. Ann Thorac Surg 75 (Supplement 6):S86–S92.  https://doi.org/10.1016/S0003-4975(03)00485-5 Google Scholar
  40. 40.
    Schmitto JD, Zimpfer D, Fiane AE, Larbalestier R, Tsui S, Jansz P, Simon A, Schueler S, Strueber M (2016) Long-term support of patients receiving a left ventricular assist device for advanced heart failure: a follow-up analysis of the Registry to Evaluate the HeartWare Left Ventricular Assist System. Eur J Cardiothorac Surg 50(5):834–838.  https://doi.org/10.1093/ejcts/ezw224 Google Scholar
  41. 41.
    Hanke JS, Dogan G, Zoch A, Ricklefs M, Wert L, Feldmann C, Bara C, Shrestha M, Tillmanns J, Kempf T, Bauersachs J, Haverich A, Schmitto JD (2018) One-year outcomes with the HeartMate 3 left ventricular assist device. J Thorac Cardiovasc Surg 156(2):662–669.  https://doi.org/10.1016/j.jtcvs.2018.01.083 Google Scholar
  42. 42.
    Gustafsson F, Rogers JG (2017) Left ventricular assist device therapy in advanced heart failure: patient selection and outcomes. Eur J Heart Fail 19(5):595–602.  https://doi.org/10.1002/ejhf.779 Google Scholar

Copyright information

© Springer-Verlag GmbH Germany, part of Springer Nature 2019

Authors and Affiliations

  • Sonja Hamed
    • 1
  • Bastian Schmack
    • 2
  • Florian Mueller
    • 1
    • 2
  • Philipp Ehlermann
    • 1
  • Davina Hittmann
    • 1
  • Arjang Ruhparwar
    • 2
    • 3
  • Hugo A. Katus
    • 1
    • 2
  • Philip W. Raake
    • 1
    • 3
  • Michael M. Kreusser
    • 1
    • 3
    Email author
  1. 1.Department of Internal Medicine III, Division of CardiologyUniversity of HeidelbergHeidelbergGermany
  2. 2.Department of Cardiac SurgeryUniversity of HeidelbergHeidelbergGermany
  3. 3.DZHK (German Center for Cardiovascular Research)HeidelbergGermany

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