Mechanical Circulatory Support in Advanced Heart Failure: Single-Center Experience A. Loforte*, A. Montalto, P. Lilla della Monica, A. Lappa, C. Contento, A. Menichetti, and F. Musumeci Department of Cardiac Surgery and Transplantation, S Camillo Hospital, Rome, Italy
ABSTRACT Background. Currently, ventricular assist device (VAD) or total artificial heart (TAH) mechanical support provides an effective treatment of unstable patients with advanced heart failure. We report our single-center experience with mechanical circulatory support therapy. Methods. From March 2002 to December 2012, 107 adult patients (mean age, 56.8 9.9 y; range, 31e76 y) were primarly supported on temporary or long-term VAD or TAH support as treatment for refractory heart failure at our institution. Temporary extracorporeal radial VAD support (group A) was established in 49 patients (45.7%), and long-term paracorporeal and intracorporeal VAD or TAH (group B) in 58 patients (54.2%). Left ventricular (LVAD) support was established in 55 patients (51.4%; n ¼ 33, Heartmate II; n ¼ 6, Heartmate I XVE; n ¼ 4, Heartware HVAD; and n ¼ 12, Centrimag) and biventricular (BVAD/TAH) support (group B) in 28 patients (26.1%; n ¼ 10, Thoratec paracorporeal; n ¼ 2, Heartware HVAD, n ¼ 1, Thoratec implantable; n ¼ 1, Syncardia TAH; and n ¼ 14, Centrimag). The temporary Centrimag was the only device adopted as isolated right ventricular (RVAD) support, and it was inserted in 24 patients (22.4%). Results. In group A, overall mean support time was 10.2 6.6 days (range, 3e43 d). In group B, LVAD mean support time was 357 352.3 days (range, 1e902 d) and BVAD/ TAH support time was 98 82.6 days (range, 8e832 d). In group A, the overall success rate was 55.1% (27 patients). In group B, LVAD overall success rate was 74.4% (32 patients) and BVAD/TAH success rate was 50% (7 patients). Overall heart transplantation rate for both groups was 27.1% (n ¼ 2, group A; n ¼ 27, group B). Overall 1-year and 5-year survivals after heart transplantation were 72.4% (n ¼ 21) and 58.6% (n ¼ 17), respectively. Conclusions. Mechanical circulatory support is an effective strategy even in cases of endstage heart failure according to our experience. Further improvement of VAD and TAH technologies may support their adoption as an encouraging alternative to heart transplantation in the near future.
M
ECHANICAL CIRCULATORY SUPPORT (MCS) for patients (patients) with advanced heart failure has evolved considerably during the past 5 decades since DeBakey’s first successful use of a ventricular assist device (VAD) in 1966 for bridge to recovery in post-cardiotomy syndrome in a 37-year-old woman [1e4]. MCS is now the standard therapy for treatment of acute or chronic endstage heart failure at many medical centers worldwide, with more MCS systems being implanted than hearts
transplanted in Europe, which will also be the case in the near future in North America [1e4]. We report our 10-year single-center experience with MCS therapy.
*Address correspondence to Dr Antonio Loforte, MD, Cardiac Surgeon, Department of Cardiac Surgery and Transplantation, S Camillo Hospital, Pza C Forlanini n 1, 00151 Rome, Italy. E-mail: [email protected]
0041-1345/14/$esee front matter http://dx.doi.org/10.1016/j.transproceed.2014.01.016
ª 2014 by Elsevier Inc. All rights reserved. 360 Park Avenue South, New York, NY 10010-1710
1476
Transplantation Proceedings, 46, 1476e1480 (2014)
MECHANICAL CIRCULATORY SUPPORT
1477
Table 1. Levitronix Centrimag Short-Term Mechanical Support System Population and Outcomes Type of Mechanical Support Duration of Support (d, mean SD) Weaned From Support Bridged to HT Died on Support Discharged
Post-cardiotomy HF
RV failure after LVAD Acute donor HF Post-AMI HF
RVAD, n ¼ 10 BVAD, n ¼ 9 LVAD, n ¼ 7 RVAD, n ¼ 14 BVAD, n ¼ 2 LVAD, n ¼ 2 BVAD, n ¼ 3 LVAD, n ¼ 2
8.9 5.6 (overall)
n¼6 n¼4 n¼3 n ¼ 12 n¼2 n¼2 d d
16.4 9.6 (overall) 7.7 0.9 (overall) 8.6 4.3 (overall)
¼ ¼ ¼ ¼ d
d n¼1 d d d
n n n n
4 4 4 2
n¼1 d
n¼2 n¼2
n¼6 n¼4 n¼2 n ¼ 11 n¼1 n¼2 n¼1 d
Abbreviations: AMI, acute myocardial infarction; BVAD, biventricular assist device; HF, heart failure; HT, heart transplantation; LVAD, left ventricular assist device; RVAD, right ventricular assist device; RV, right ventricular.
METHODS From March 2002 to December 2012, 107 adult patients (mean age, 56.8 9.9 y; range, 31e76 y) were primarily supported on temporary or long-term VAD or total artificial heart (TAH) support as treatment for refractory heart failure at our institution (Tables 1 and 2). Temporary extracorporeal radial VAD support (group A) was established in 49 patients (45.7%) and long-term paracorporeal and intracorporeal VAD or TAH support (group B) in 58 patients (54.2%). Body surface area of the overall patient population was 1.75 0.19 m2 (range, 1.54e1.99 m2). In group A, the temporary Levitronix Centrimag (Levitronix, Waltham, Massachusetts) radial-flow pump was used in a left-, right-, or bi-ventricular assist device (LVAD, RVAD, or BVAD) configuration. In group B, the following long-term LVAD systems were used: Heartmate I XVE (Thoratec, Pleasanton, California), Heartmate II (Thoratec), and Heartware HVAD (Heartware, Miramar, Florida). For biventricular support the following longterm systems were used in group B: Thoratec paracorporeal and implantable VADs, Heartware HVAD, and Syncardia TAH (Syncardia Systems, Tucson, Arizona). The VAD and TAH systems were surgically placed in traditional fashion as described elsewhere [5e10]. We adopted the anticoagulation protocol proposed by each device company [5e10]. Written informed consent was obtained from every patient before surgery. LVAD support was established in 55 patients (51.4%; n ¼ 33, Heartmate II; n ¼ 6, Heartmate I XVE; n ¼ 4, Heartware HVAD; and n ¼ 12, Centrimag) and BVAD/TAH support (group B) in 28 patients (26.1%; n ¼ 10, Thoratec paracorporeal, n ¼ 2, Heartware HVAD; n ¼ 1, Thoratec implantable; n ¼ 1, Syncardia TAH; and n ¼ 14, Centrimag). The temporary Centrimag was the only device adopted as isolated RVAD support, and it was inserted in 24 patients (22.4%; n ¼ 10 in the postcardiotomy cohort; n ¼ 14 in the long-term LVAD cohort). In group A, indications for support were: failure to wean from cardiopulmonary bypass (n ¼ 44) after cardiotomy (n ¼ 26), primary donor graft failure (n ¼ 4) or right ventricular (RV) failure after axial or centrifugal LVAD placement (n ¼ 14); and (n ¼ 5) refractory heart failure after acute myocardial infarction (AMI). In
group B, indication at implantation were: ischemic dilative cardiomyopathy (DCMP) in 31 patients, idiopathic DCMP in 25 patients, and post-myocarditis DCMP in 2. At time of implantation Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) level was 1 in all patients of group A, 2 in 4 of the LVAD patients and 5 of BVAD/ TAH patients of group B, and 3 in the rest of VAD/TAH patients of group B. The majority of patients received an intra-aortic balloon pump support before VAD therapy (83.1%; n ¼ 40 in group A; n ¼ 49 in group B) according to Haussman score [1,2,11]. Overall, 14 patients (13.08%) had undergone earlier open heart surgery (n ¼ 9 in group A; n ¼ 5 in group B). Regarding preoperative vital status of patients, the Simplified Acute Physiology (SAPS) II score [1,2,10] was 18.7 (range, 10e31) in LVAD patients and 30.6 (range, 26e45) in BVAD/TAH patients. The preoperative inotropic score [1,2] was 16.2 (range, 10e27) in LVAD patients and 28.5 (range, 20e45) in BVAD/TAH patients. Preoperative laboratory N-terminal proeBtype natriuretic peptide (NT-proBNP) [1,2] was 8,610 pg/mL (range, 5,215e10,233 pg/mL) in LVAD patients and 13,780 pg/mL (range, 10,110e18,455 pg/mL) in BVAD/TAH patients. Regarding RV function assessment, preoperative Michigan and Pennsylvania scores, as described elsewhere in terms of personal adoption [2,10], were, respectively, 3.1 (range, 2.2e4.0) and 32.7 (range, 24e45) in LVAD patients and 5.6 (range, 4.1e6.1) and 54.6 (range, 49.4e62) in BVAD/TAH patients. Preoperative RV short to long axis ratio (S/L ratio) >0.65 and right ventricleetoeleft ventricle end-diastolic diameter ratio (R/L ratio) 100 patients and partially described elsewhere [12]. During the study period, there was a notably low incidence of myocarditis (n ¼ 2) that required an implantable LVAD support, with 1 case of myocardial recovery and successful explantation of the pump, and poor evolution of post-AMI cases that developed MOF under circulatory support, being a preoperatively severely ill cohort of patients who were all late referred by other institutions with preoperative high SAPS II and inotropic scores, as discussed elsewhere [9], versus an excellent rate of recovery in patients with post-cardiotomy shock, probably thanks to rapid and aggressive treatment (only 1 attempt to be weaned off from cardiopulmonary bypass, no prolonged pharmacologic myocardial stress by inotropic and/or vasoactive drug use, prompt central mechanical cardiac unloading, and support). We had a positive experience with intracorporeal longterm devices, leading to the possibility of discharging several patients home, where they could thus recover a good social life, an experience we did not achieve with the paracorporeal systems. Discharging subjects home is an important therapeutic option both for the individuals and to optimize health care resources, considering the longer and longer time on HT waiting lists and the consequent eventual option for permanent support (DT). We had a low rate of HT (27%) owing to severe lack of donors and long time on the waiting list for transplantation (>2 y), as is typical in the southern and middle parts of our country. Therefore, mechanical support may be prolonged at our institution for >1 year and become in time a permanent solution, even owing to VAD patients’ satisfaction and willingness not to receive HT anymore. However, studies regarding quality of life evaluation are still under investigation at our institution. Chronic VAD/TAH therapy has become a clinical reality, and a greater number of patients are not receiving their transplants in time, even according to recent European and North American data reports [1e4,13]. Therefore, when the decision to treat with VAD or TAH is made early, it can be used as an encouraging alternative form of treatment with similar survival, at least at 1 year [1e4,13], even according to our experience (Fig 1). Both the improved durability and low complication rate profile may allow the utilization of such a therapy in older or sicker patients, which was not possible with earlier types of devices, and even provide a shift from “saving the life” of patients with severe cardiogenic shock and New York Heart Association (NYHA) functional class IV status to improving the quality of life of patients with NYHA functional class III or IV by means of long-term and permanent VAD/TAH support in the near future. As a limitation of this report, costs where not analyzed. According to the literature [14e16], hospital costs are higher for VAD therapy compared with HT, mainly because of the cost of the devices themselves and the actual lack of an adequate reimbursement in most of countries. It should be considered that it is well accepted that first 2- to 3-year
1479
Fig 1. Kaplan-Meier analysis showing survival outcomes of permanent ventricular assist device (VAD) patients (destination therapy cohort) and heart transplantation patients who received no VAD support before.
outcomes for patients eligible for HT are similar whether they receive an allograft or continuous-flow LVAD only for bridge to transplantation, and HT outcome for patients with LVADs are not adversely affected [13]. Thus, improving outcomes for patients treated with LVADs suggest that current decision models for patients eligible for HT may need to be reevaluated, especially in areas where the lack of donors and long times on the waiting list are still a limit, as at our institution. In the future, eventual reduction of device cost and better official reimbursement may change the scenario for treatment of such a delicate population of patients [13e16]. Progressive improvements in operative technique and postoperative management, and adoption of latest-generation continuous-flow technology, might play critical roles for further additional cost reduction. ACKNOWLEDGMENTS The authors are grateful to all of the cardioperfusion team of S Camillo Hospital, Rome, for their enormous contribution in the technical and clinical management of VAD/TAH patients. The authors are also grateful to all of the MCS team of the Deutsches Herzzentrum Berlin for their continuous support.
REFERENCES [1] Potapov EV, Loforte A, Weng Y, et al. Experience with over 1000 implated ventricular assist devices. J Card Surg 2008;23: 184e94. [2] Potapov EV, Krabatsch T, Ventura HO, Hetzer R. Advances in mechanical circulatory support: Year in review. J Heart Lung Transplant 2011;30:487e93. [3] Strueber M, Meyer AL, Malehsa D, et al. The current status of heart transplantation and the development of “artificial heart systems”. Dtsch Arztebl Int 2009;106:471e7. [4] Krabatsch T, Potapov EV, Knosalla C, Hetzer R. Ventricular assist devices for all? Eur J Cardiothorac Surg 2012;42:918e9.
1480 [5] Loforte A, Montalto A, Ranocchi F, et al. Heartmate II axialflow left ventricular assist system: management, clinical review and personal experience. J Cardiovasc Med 2009;10:756e71. [6] Slaughter MS, Pagani FD, Rogers JG, et al. Clinical management of continuous-flow left ventricular assist devices in advanced heart failure. J Heart Lung Transplant 2010;29(Suppl 4): S1e39. [7] Slepian M. The Syncardia temporary total artificial heartd evolving clinical role and future status. US Cardiol 2011;8:39e46. [8] Krabatsch T, Potapov EV, Stepanenko A, et al. Biventricular circulatory support with two miniaturized implantable assist devices. Circulation 2011;124(Suppl 1):S179e86. [9] Loforte A, Montalto A, Ranocchi F, et al. Levitronix Centrimag third-generation magnetically levitated continuous flow pump as bridge to solution. ASAIO J 2011;57:247e53. [10] Loforte A, Stepanenko A, Potapov EV, et al. Temporary right ventricular mechanical support in high-risk left ventricular assist device recipients versus permanent biventricular or total artificial heart support. Artif Organs 2013;37:523e30.
LOFORTE, MONTALTO, LILLA DELLA MONICA ET AL [11] Hausmann H, Potapov EV, Koster A, et al. Prognosis after the implantation of an intra-aortic balloon pump in cardiac surgery calculated with a new score. Circulation 2002;106:I203e6. [12] Loforte A, Montalto A, Ranocchi F, et al. Peripheral membrane oxygenation system as salvage treatment of patients with refractory cardiogenic shock: preliminary outcome evaluation. Artif Organs 2012;36:53e61. [13] Garbade J, Barten MJ, Bittner HB, Mohr FW. Heart transplantation and left ventricular assist device therapy: two comparable options in end-stage heart failure? Clin Cardiol 2013;36:378e82. [14] Williams ML, Trivedi JR, McCants KC, et al. Heart transplant vs left ventricular assist device in heart transplanteligible patients. Ann Thorac Surg 2011;91:1330e4. [15] Slaughter MS, Bostic R, Tong K, Russo M, Rogers JG. Temporal changes in hospital costs for left ventricular assist device implantation. J Card Surg 2011;26:535e41. [16] Mishra V, Geiran O, Fiane AE, et al. Costs and reimbursement gaps after implementation of third-generation left ventricular assist devices. J Heart Lung Transplant 2010;29:72e8.
ABSTRACT Background. Currently, ventricular assist device (VAD) or total artificial heart (TAH) mechanical support provides an effective treatment of unstable patients with advanced heart failure. We report our single-center experience with mechanical circulatory support therapy. Methods. From March 2002 to December 2012, 107 adult patients (mean age, 56.8 9.9 y; range, 31e76 y) were primarly supported on temporary or long-term VAD or TAH support as treatment for refractory heart failure at our institution. Temporary extracorporeal radial VAD support (group A) was established in 49 patients (45.7%), and long-term paracorporeal and intracorporeal VAD or TAH (group B) in 58 patients (54.2%). Left ventricular (LVAD) support was established in 55 patients (51.4%; n ¼ 33, Heartmate II; n ¼ 6, Heartmate I XVE; n ¼ 4, Heartware HVAD; and n ¼ 12, Centrimag) and biventricular (BVAD/TAH) support (group B) in 28 patients (26.1%; n ¼ 10, Thoratec paracorporeal; n ¼ 2, Heartware HVAD, n ¼ 1, Thoratec implantable; n ¼ 1, Syncardia TAH; and n ¼ 14, Centrimag). The temporary Centrimag was the only device adopted as isolated right ventricular (RVAD) support, and it was inserted in 24 patients (22.4%). Results. In group A, overall mean support time was 10.2 6.6 days (range, 3e43 d). In group B, LVAD mean support time was 357 352.3 days (range, 1e902 d) and BVAD/ TAH support time was 98 82.6 days (range, 8e832 d). In group A, the overall success rate was 55.1% (27 patients). In group B, LVAD overall success rate was 74.4% (32 patients) and BVAD/TAH success rate was 50% (7 patients). Overall heart transplantation rate for both groups was 27.1% (n ¼ 2, group A; n ¼ 27, group B). Overall 1-year and 5-year survivals after heart transplantation were 72.4% (n ¼ 21) and 58.6% (n ¼ 17), respectively. Conclusions. Mechanical circulatory support is an effective strategy even in cases of endstage heart failure according to our experience. Further improvement of VAD and TAH technologies may support their adoption as an encouraging alternative to heart transplantation in the near future.
M
ECHANICAL CIRCULATORY SUPPORT (MCS) for patients (patients) with advanced heart failure has evolved considerably during the past 5 decades since DeBakey’s first successful use of a ventricular assist device (VAD) in 1966 for bridge to recovery in post-cardiotomy syndrome in a 37-year-old woman [1e4]. MCS is now the standard therapy for treatment of acute or chronic endstage heart failure at many medical centers worldwide, with more MCS systems being implanted than hearts
transplanted in Europe, which will also be the case in the near future in North America [1e4]. We report our 10-year single-center experience with MCS therapy.
*Address correspondence to Dr Antonio Loforte, MD, Cardiac Surgeon, Department of Cardiac Surgery and Transplantation, S Camillo Hospital, Pza C Forlanini n 1, 00151 Rome, Italy. E-mail: [email protected]
0041-1345/14/$esee front matter http://dx.doi.org/10.1016/j.transproceed.2014.01.016
ª 2014 by Elsevier Inc. All rights reserved. 360 Park Avenue South, New York, NY 10010-1710
1476
Transplantation Proceedings, 46, 1476e1480 (2014)
MECHANICAL CIRCULATORY SUPPORT
1477
Table 1. Levitronix Centrimag Short-Term Mechanical Support System Population and Outcomes Type of Mechanical Support Duration of Support (d, mean SD) Weaned From Support Bridged to HT Died on Support Discharged
Post-cardiotomy HF
RV failure after LVAD Acute donor HF Post-AMI HF
RVAD, n ¼ 10 BVAD, n ¼ 9 LVAD, n ¼ 7 RVAD, n ¼ 14 BVAD, n ¼ 2 LVAD, n ¼ 2 BVAD, n ¼ 3 LVAD, n ¼ 2
8.9 5.6 (overall)
n¼6 n¼4 n¼3 n ¼ 12 n¼2 n¼2 d d
16.4 9.6 (overall) 7.7 0.9 (overall) 8.6 4.3 (overall)
¼ ¼ ¼ ¼ d
d n¼1 d d d
n n n n
4 4 4 2
n¼1 d
n¼2 n¼2
n¼6 n¼4 n¼2 n ¼ 11 n¼1 n¼2 n¼1 d
Abbreviations: AMI, acute myocardial infarction; BVAD, biventricular assist device; HF, heart failure; HT, heart transplantation; LVAD, left ventricular assist device; RVAD, right ventricular assist device; RV, right ventricular.
METHODS From March 2002 to December 2012, 107 adult patients (mean age, 56.8 9.9 y; range, 31e76 y) were primarily supported on temporary or long-term VAD or total artificial heart (TAH) support as treatment for refractory heart failure at our institution (Tables 1 and 2). Temporary extracorporeal radial VAD support (group A) was established in 49 patients (45.7%) and long-term paracorporeal and intracorporeal VAD or TAH support (group B) in 58 patients (54.2%). Body surface area of the overall patient population was 1.75 0.19 m2 (range, 1.54e1.99 m2). In group A, the temporary Levitronix Centrimag (Levitronix, Waltham, Massachusetts) radial-flow pump was used in a left-, right-, or bi-ventricular assist device (LVAD, RVAD, or BVAD) configuration. In group B, the following long-term LVAD systems were used: Heartmate I XVE (Thoratec, Pleasanton, California), Heartmate II (Thoratec), and Heartware HVAD (Heartware, Miramar, Florida). For biventricular support the following longterm systems were used in group B: Thoratec paracorporeal and implantable VADs, Heartware HVAD, and Syncardia TAH (Syncardia Systems, Tucson, Arizona). The VAD and TAH systems were surgically placed in traditional fashion as described elsewhere [5e10]. We adopted the anticoagulation protocol proposed by each device company [5e10]. Written informed consent was obtained from every patient before surgery. LVAD support was established in 55 patients (51.4%; n ¼ 33, Heartmate II; n ¼ 6, Heartmate I XVE; n ¼ 4, Heartware HVAD; and n ¼ 12, Centrimag) and BVAD/TAH support (group B) in 28 patients (26.1%; n ¼ 10, Thoratec paracorporeal, n ¼ 2, Heartware HVAD; n ¼ 1, Thoratec implantable; n ¼ 1, Syncardia TAH; and n ¼ 14, Centrimag). The temporary Centrimag was the only device adopted as isolated RVAD support, and it was inserted in 24 patients (22.4%; n ¼ 10 in the postcardiotomy cohort; n ¼ 14 in the long-term LVAD cohort). In group A, indications for support were: failure to wean from cardiopulmonary bypass (n ¼ 44) after cardiotomy (n ¼ 26), primary donor graft failure (n ¼ 4) or right ventricular (RV) failure after axial or centrifugal LVAD placement (n ¼ 14); and (n ¼ 5) refractory heart failure after acute myocardial infarction (AMI). In
group B, indication at implantation were: ischemic dilative cardiomyopathy (DCMP) in 31 patients, idiopathic DCMP in 25 patients, and post-myocarditis DCMP in 2. At time of implantation Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) level was 1 in all patients of group A, 2 in 4 of the LVAD patients and 5 of BVAD/ TAH patients of group B, and 3 in the rest of VAD/TAH patients of group B. The majority of patients received an intra-aortic balloon pump support before VAD therapy (83.1%; n ¼ 40 in group A; n ¼ 49 in group B) according to Haussman score [1,2,11]. Overall, 14 patients (13.08%) had undergone earlier open heart surgery (n ¼ 9 in group A; n ¼ 5 in group B). Regarding preoperative vital status of patients, the Simplified Acute Physiology (SAPS) II score [1,2,10] was 18.7 (range, 10e31) in LVAD patients and 30.6 (range, 26e45) in BVAD/TAH patients. The preoperative inotropic score [1,2] was 16.2 (range, 10e27) in LVAD patients and 28.5 (range, 20e45) in BVAD/TAH patients. Preoperative laboratory N-terminal proeBtype natriuretic peptide (NT-proBNP) [1,2] was 8,610 pg/mL (range, 5,215e10,233 pg/mL) in LVAD patients and 13,780 pg/mL (range, 10,110e18,455 pg/mL) in BVAD/TAH patients. Regarding RV function assessment, preoperative Michigan and Pennsylvania scores, as described elsewhere in terms of personal adoption [2,10], were, respectively, 3.1 (range, 2.2e4.0) and 32.7 (range, 24e45) in LVAD patients and 5.6 (range, 4.1e6.1) and 54.6 (range, 49.4e62) in BVAD/TAH patients. Preoperative RV short to long axis ratio (S/L ratio) >0.65 and right ventricleetoeleft ventricle end-diastolic diameter ratio (R/L ratio) 100 patients and partially described elsewhere [12]. During the study period, there was a notably low incidence of myocarditis (n ¼ 2) that required an implantable LVAD support, with 1 case of myocardial recovery and successful explantation of the pump, and poor evolution of post-AMI cases that developed MOF under circulatory support, being a preoperatively severely ill cohort of patients who were all late referred by other institutions with preoperative high SAPS II and inotropic scores, as discussed elsewhere [9], versus an excellent rate of recovery in patients with post-cardiotomy shock, probably thanks to rapid and aggressive treatment (only 1 attempt to be weaned off from cardiopulmonary bypass, no prolonged pharmacologic myocardial stress by inotropic and/or vasoactive drug use, prompt central mechanical cardiac unloading, and support). We had a positive experience with intracorporeal longterm devices, leading to the possibility of discharging several patients home, where they could thus recover a good social life, an experience we did not achieve with the paracorporeal systems. Discharging subjects home is an important therapeutic option both for the individuals and to optimize health care resources, considering the longer and longer time on HT waiting lists and the consequent eventual option for permanent support (DT). We had a low rate of HT (27%) owing to severe lack of donors and long time on the waiting list for transplantation (>2 y), as is typical in the southern and middle parts of our country. Therefore, mechanical support may be prolonged at our institution for >1 year and become in time a permanent solution, even owing to VAD patients’ satisfaction and willingness not to receive HT anymore. However, studies regarding quality of life evaluation are still under investigation at our institution. Chronic VAD/TAH therapy has become a clinical reality, and a greater number of patients are not receiving their transplants in time, even according to recent European and North American data reports [1e4,13]. Therefore, when the decision to treat with VAD or TAH is made early, it can be used as an encouraging alternative form of treatment with similar survival, at least at 1 year [1e4,13], even according to our experience (Fig 1). Both the improved durability and low complication rate profile may allow the utilization of such a therapy in older or sicker patients, which was not possible with earlier types of devices, and even provide a shift from “saving the life” of patients with severe cardiogenic shock and New York Heart Association (NYHA) functional class IV status to improving the quality of life of patients with NYHA functional class III or IV by means of long-term and permanent VAD/TAH support in the near future. As a limitation of this report, costs where not analyzed. According to the literature [14e16], hospital costs are higher for VAD therapy compared with HT, mainly because of the cost of the devices themselves and the actual lack of an adequate reimbursement in most of countries. It should be considered that it is well accepted that first 2- to 3-year
1479
Fig 1. Kaplan-Meier analysis showing survival outcomes of permanent ventricular assist device (VAD) patients (destination therapy cohort) and heart transplantation patients who received no VAD support before.
outcomes for patients eligible for HT are similar whether they receive an allograft or continuous-flow LVAD only for bridge to transplantation, and HT outcome for patients with LVADs are not adversely affected [13]. Thus, improving outcomes for patients treated with LVADs suggest that current decision models for patients eligible for HT may need to be reevaluated, especially in areas where the lack of donors and long times on the waiting list are still a limit, as at our institution. In the future, eventual reduction of device cost and better official reimbursement may change the scenario for treatment of such a delicate population of patients [13e16]. Progressive improvements in operative technique and postoperative management, and adoption of latest-generation continuous-flow technology, might play critical roles for further additional cost reduction. ACKNOWLEDGMENTS The authors are grateful to all of the cardioperfusion team of S Camillo Hospital, Rome, for their enormous contribution in the technical and clinical management of VAD/TAH patients. The authors are also grateful to all of the MCS team of the Deutsches Herzzentrum Berlin for their continuous support.
REFERENCES [1] Potapov EV, Loforte A, Weng Y, et al. Experience with over 1000 implated ventricular assist devices. J Card Surg 2008;23: 184e94. [2] Potapov EV, Krabatsch T, Ventura HO, Hetzer R. Advances in mechanical circulatory support: Year in review. J Heart Lung Transplant 2011;30:487e93. [3] Strueber M, Meyer AL, Malehsa D, et al. The current status of heart transplantation and the development of “artificial heart systems”. Dtsch Arztebl Int 2009;106:471e7. [4] Krabatsch T, Potapov EV, Knosalla C, Hetzer R. Ventricular assist devices for all? Eur J Cardiothorac Surg 2012;42:918e9.
1480 [5] Loforte A, Montalto A, Ranocchi F, et al. Heartmate II axialflow left ventricular assist system: management, clinical review and personal experience. J Cardiovasc Med 2009;10:756e71. [6] Slaughter MS, Pagani FD, Rogers JG, et al. Clinical management of continuous-flow left ventricular assist devices in advanced heart failure. J Heart Lung Transplant 2010;29(Suppl 4): S1e39. [7] Slepian M. The Syncardia temporary total artificial heartd evolving clinical role and future status. US Cardiol 2011;8:39e46. [8] Krabatsch T, Potapov EV, Stepanenko A, et al. Biventricular circulatory support with two miniaturized implantable assist devices. Circulation 2011;124(Suppl 1):S179e86. [9] Loforte A, Montalto A, Ranocchi F, et al. Levitronix Centrimag third-generation magnetically levitated continuous flow pump as bridge to solution. ASAIO J 2011;57:247e53. [10] Loforte A, Stepanenko A, Potapov EV, et al. Temporary right ventricular mechanical support in high-risk left ventricular assist device recipients versus permanent biventricular or total artificial heart support. Artif Organs 2013;37:523e30.
LOFORTE, MONTALTO, LILLA DELLA MONICA ET AL [11] Hausmann H, Potapov EV, Koster A, et al. Prognosis after the implantation of an intra-aortic balloon pump in cardiac surgery calculated with a new score. Circulation 2002;106:I203e6. [12] Loforte A, Montalto A, Ranocchi F, et al. Peripheral membrane oxygenation system as salvage treatment of patients with refractory cardiogenic shock: preliminary outcome evaluation. Artif Organs 2012;36:53e61. [13] Garbade J, Barten MJ, Bittner HB, Mohr FW. Heart transplantation and left ventricular assist device therapy: two comparable options in end-stage heart failure? Clin Cardiol 2013;36:378e82. [14] Williams ML, Trivedi JR, McCants KC, et al. Heart transplant vs left ventricular assist device in heart transplanteligible patients. Ann Thorac Surg 2011;91:1330e4. [15] Slaughter MS, Bostic R, Tong K, Russo M, Rogers JG. Temporal changes in hospital costs for left ventricular assist device implantation. J Card Surg 2011;26:535e41. [16] Mishra V, Geiran O, Fiane AE, et al. Costs and reimbursement gaps after implementation of third-generation left ventricular assist devices. J Heart Lung Transplant 2010;29:72e8.
