The role of Heart Failure Team in managing Mechanical Circulatory Support in a Swiss low-volume institution
Background. Outcomes after VAD implantation may be dependent on institutional procedural volume. Specifically, it is claimed that high volumes are associated to better clinical results. This study aims to determine if this procedure is safe even in low‐volume center. Methods. Single center, retrospective cohort study, including Heart Failure consecutive patients who received long-term VAD from 2007 to 2017. Primary outcome was survival to transplant or ongoing MCS at 1-year. Survival analysis was performed using Kaplan-Meier method. Results. Data concerning 50 adult patients were examined; 35 male (70%), mean age 49+/- 8 years. VAD was implanted as BTT in 48 and DT in 2. Devices implanted were: HeartMate II in 18 (36%), HeartWare in 20 (40%), HeartMate III in 12 (24%). Outcomes were: Death in 16 (32%), heart transplant in 24 (48%), uneventful ongoing support 10 (20%). Data were analysed according to pre and post-heart team creation and 2 groups of 25 patients were identified: 2007-2013 (mean INTERMACS level 3.1) and 2014-2017 (mean INTERMACS level 3.9) showing 1-year survival of 56% and 80% respectively. According to the type of device implanted, 3 groups were identified: HMII = 18 (mean INT. level 2.7), HW=20 (mean INT. level 3.3) and HMIII=12 (mean INT. level 3.7), showing survival of 52%, 78% and 91% respectively. Conclusions. Long term MCS can be implanted at low-volume centers with survival rate not inferior to high volume centers. A Heart team specifically trained in heart failure is probably more important than institutional volume in determining outcomes after VAD implantation.
Birkmeyer JD1, Siewers AE, Finlayson EV, Stukel TA, Lucas FL, Batista I, Welch HG, Wennberg D. Hospital volume and surgical mortality in the United States. N Engl J Med. 2002 (11);346(15):1128-37
Begg CB, Cramer LD, Hoskins WJ, Brennan MF. Impact of hospital volume on operative mortality for major cancer surgery. JAMA 1998;280:1747-1751
Finks JF, Osborne NH, Birkmayer JD. Trends in Hospital volume and operative mortality for high risk surgery. N Engl J Med 2011;364:2128-37
Qian F, Lustik SJ, Diachun CA, Wissler RN, Zollo RA, Glance LG. Association between Leapfrog safe practices score and hospital mortality in major surgery. Med Care. 2011;49(12):1082-8.
LaPar DJ, Kron IL, Jones DR, Stukenborg GJ, Kozower BD. Hospital procedure volume should not be used as a measure of surgical quality. Ann Surg. 2012 Oct;256(4):606-15
Rose EA, Gelijns AC, Moskowitz AJ, Heitjan DF, et al. Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure (REMATCH) Study Group. Long-term mechanical left ventricular assistance for end-stage heart failure. N Engl J Med. 2001; 345: 1435–1443
Lietz K, Long JW, Kfoury AG, Slaughter MS, et al. Impact of center volume on outcomes of left ventricular assist device implantation as destination therapy: analysis of the Thoratec HeartMate Registry, 1998 to 2005. Circ Heart Fail. 2009 Jan;2(1):3-10
Chowdhury MM, Dagash H, Pierro A. A systematic review of the impact of volume of surgery and specialization on patient outcome. Br J Surg 2007;94:145-61
Kip K. The problem with composite end points in cardiovascular studies: the story of major adverse cardiac events and percutaneous coronary intervention.J Am Coll Cardiol. 2008 Feb 19;51(7):701-7
Tozzi P, Hullin R. Mechanical circulatory support for destination therapy.
Swiss Med Wkly. 2016 5;146:w14267
Atluri P, Goldstone AB, Fairman AS, MacArthur JW, Shudo Y, Cohen JE, Acker AL, Hiesinger W, Howard JL, Acker MA, Woo YJ. Predicting right ventricular failure in the modern, continuous flow left ventricular assist device era. Ann Thorac Surg. 2013 Sep;96(3):857-63
Lietz K, Long JW, Kfoury AG, Slaughter MS, Silver MA, Milano CA, Rogers JG, Naka Y, Mancini D, Miller LW. Outcomes of left ventricular assist device implantation as destination therapy in the post-REMATCH era. Implications for patient selection. Circulation. 2007; 116: 497–505
Park SJ, Tector A, Piccioni W, Raines E, Gelijns A, Moskowitz A, Rose E, Holman W, Furukawa S, Frazier OW, Dembitsky W. Left ventricular assist devices as destination therapy: a new look at survival. J Thorac Cardiovasc Surg. 2005;129: 9–1
Dean D, Kallel F, Ewald GA, Tatooles A, Sheridan BC, Brewer RJ, Caldeira C, Farrar DJ, Akhter SA. Reduction in driveline infection rates: Results from the HeartMate II Multicenter Driveline Silicone Skin Interface (SSI) Registry. J Heart Lung Transplant. 2015 Jun;34(6):781-9.
Takeda K, Takayama H, Kalesan B, Uriel N, Colombo PC, Jorde UP, Naka Y. Long-term outcome of patients on continuous-flow left ventricular assist device support. J Thorac Cardiovasc Surg. 2014 Oct;148(4):1606-14.
A Fully Magnetically Levitated Circulatory Pump for Advanced Heart Failure. 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; MOMENTUM 3 Investigators. N Engl J Med. 2016 Nov 16
Schmitto JD, Zimpfer D, Fiane AE, Larbalestier R, Tsui S, Jansz P, Simon A, Schueler S, Strueber M. 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. 2016 Nov;50(5):834-838.
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