- Email: [email protected]
Early Outcomes With Marginal Donor Hearts Compared With Left Ventricular Assist Device Support in Patients With Advanced Heart Failure
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Early Outcomes With Marginal Donor Hearts Compared With Left Ventricular Assist Device Support in Patients With Advanced Heart Failure Erin M. Schumer, MD,* Mickey S. Ising, MEng,* Jaimin R. Trivedi, MD, MPH, Mark S. Slaughter, MD, and Allen Cheng, MD Department of Cardiovascular and Thoracic Surgery, University of Louisville, Louisville, Kentucky
Background. The shortage of donor hearts has limited cardiac transplantation for end-stage heart failure, leading to the increased use of left ventricular assist devices (LVADs) as bridge-to-transplant (BTT) and marginal donor hearts; however, outcomes have been mixed. This study examines differences in wait list survival of patients with continuous flow LVADs and post-transplantation survival of patients receiving a marginal donor heart. Methods. The United Network of Organ Sharing database was retrospectively queried from January 2005 to June 2013 to identify adult patients listed for heart transplant. Marginal donor criteria included age greater than 55 years, hepatitis C positive, cocaine use, ejection fraction less than 0.45, or donor to recipient body mass index mismatch of greater than 20%. The primary endpoint was wait list survival of patients with LVADs compared with post-transplant survival of marginal donor heart recipients using Kaplan-Meier analysis.
Results. A total of 2,561 and 4,737 patients received LVAD support or a marginal donor heart, respectively. The 30-day, 1-year, and 2-year survival was 96%, 89%, and 85%, for patients with LVAD support on the waiting list and 97%, 89%, and 85%, respectively, for recipients of marginal donor hearts (p [ 0.213). Recipients of marginal hearts had worse survival than non-marginal heart recipients at 3 years (p [ 0.011). Conclusions. There was no significant difference between waiting list survival of patients with LVAD support as BTT and post-transplant survival of recipients with marginal donor hearts. There could be clinical benefits for using LVAD support as BTT to allow time for better allocation of optimal donor hearts as opposed to transplantation with a marginal donor heart.
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mismatch greater than 20% [5, 6]. Survival outcomes are generally worse for recipients of marginal donor hearts by up to 20% at 5 years although there is evidence of similar early outcomes [7, 8]. Alternatively, outcomes for patients receiving contemporary continuous flow LVADs as support for BTT have been associated with improved patient survival and are not limited by supply [4, 9–11]. While LVADs as BTT and the use of marginal donor hearts have expanded treatment options for patients with ESHD, the best treatment option and long-term survival outcomes remain unclear [12, 13]. In an effort to help improve the decision-making process, we used the United Organ Sharing Network (UNOS) database to evaluate potential survival differences between patients on the waiting list with a contemporary continuous flow LVAD compared with heart transplant recipients of extended-criteria donor hearts.
nd-stage heart disease (ESHD) currently affects 5.1 million people in the United States with an estimated growth in incidence of 25% by 2030 [1]. Heart transplantation remains the gold standard treatment for patients with ESHD; however, the supply of donor organs remains limited [2]. This limited supply of appropriate donor organs has led to the development and increased use left ventricular assist devices (LVADs) as bridge-totransplant (BTT) therapy [1–4]. Simultaneously, marginal or “extended-criteria” donor organs are being used in an effort to increase the donor organ pool [2]. While no standardized criteria exist, general consensus in the literature indicates that a donor organ is considered marginal when the donor has the following characteristics: age greater than 55 years old; hepatitis C positive; cocaine use; ejection fraction less than 0.45; or donor to recipient body mass index (BMI) Accepted for publication Feb 19, 2015. *Erin Schumer and Mickey Ising contributed equally to the study. Presented at the Sixty-first Annual Meeting of the Southern Thoracic Surgical Association, Tucson, AZ, Nov 5–8, 2014. Address correspondence to Dr Cheng, University of Louisville, Department of Thoracic and Cardiovascular Surgery, 201 Abraham Flexner Way, Ste 1200, Louisville, KY 40202; e-mail: [email protected].
Ó 2015 by The Society of Thoracic Surgeons Published by Elsevier
(Ann Thorac Surg 2015;100:522–7) Ó 2015 by The Society of Thoracic Surgeons
Patients and Methods Data were obtained from the UNOS registry for patients listed for heart transplantation from January 2005 through June 2013. The entire UNOS registry for this time period consisted of 136,498 patients. Patients were included in the study if they were listed for heart transplantation, 0003-4975/$36.00 http://dx.doi.org/10.1016/j.athoracsur.2015.02.089
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A p value of 0.05 or less was considered statistically significant.
Results Analysis included a total of 7,298 patients divided into 2 groups. There were 2,561 patients in the LVAD group and 4,737 patients in the MD group. Similar baseline preoperative characteristics for both groups included age and pulmonary artery pressure; however, the proportion of males and diabetics, BMI, cardiac output, and wait list time were higher for the LVAD group. The MD group had a higher proportion of patients listed as UNOS status IA and higher creatinine. Demographic information for both groups is summarized in Table 1. Dilated cardiomyopathy due to all causes was the most common etiology of heart failure in both groups; 3,819 (80.62%) for the MD group and 2,419 (94.46%) for the LVAD group. The distribution of diagnoses for heart failure is shown in Table 2. The proportion of diagnoses was markedly different for these 2 populations for all diagnoses. Annual case distribution for 2005 to 2013 is shown in Figure 2 and reflects the number of LVADs placed at time of listing and marginal donor hearts at time of transplant. With the exception of 2005 and 2013, the number of marginal donor heart transplantations remained similar. The MD group was then further classified by marginal donor characteristics (Table 3). The BMI mismatch and donor history of cocaine use, respectively, accounted for 59.87% (n ¼ 2,836) and 18.41% (n ¼ 872) for classification
Fig 1. Flow chart of selection of patients for analysis using the United Network for Organ Sharing database. The left-ventricular assist device group, n ¼ 2,561; marginal donor group, n ¼ 4,737. (HMII ¼ HeartMate II; HVAD ¼ heart ventricular assist device; MCS ¼ mechanical circulatory support device.)
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were 18 or greater years old, and listed after December 31, 2004 (n ¼ 24,039). Patients were excluded if the wait list criteria were listed as refused transplantation, transferred to another center, other, condition improved, too ill for transplant, removed in error, emergency transplantation, died during transplantation, or unable to contact. The study population was then divided into 2 groups. Patients in the LVAD group were included if they received a continuous flow LVAD, either HeartMate II (Thoratec, Pleasanton, CA) or HVAD (Heartware, Inc, Miami Lakes, FL) at time of listing (n ¼ 2,561). The marginal donor (MD) group includes patients who underwent heart transplantation without ever having received an LVAD and underwent transplantation with a marginal donor heart (n ¼ 4,737). Marginal donor criteria included age greater than 55 years old, hepatitis C positive, cocaine use, ejection fraction less than 0.45, or donor to recipient (BMI) greater mismatch of 20%) [5, 6]. The full algorithm for the study design is shown in Figure 1. The primary outcome of this study was comparison of survival between patients on the waiting list with a continuous flow LVAD and patients transplanted with a marginal donor heart. All statistical analyses were completed using SPSS v. 22 (IBM, Armonk, NY). All reported results are at time of LVAD implantation for the LVAD group and time of transplantation for the MD group. The Student t test and c2 analysis were used to compare study group characteristics. Kaplan-Meier survival analysis was used to compare survival between study groups. Values are report as n (percent) or average standard deviation.
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SCHUMER ET AL MARGINAL DONOR HEARTS COMPARED WITH LVADS
Table 1. Characteristics of the Left Ventricular Assist Device (LVAD) Group and Marginal Donor (MD) Heart Groupa
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Characteristic Age (years) Sex (male) BMI Diabetes UNOS status IA PAP (mm Hg) Creatinine Cardiac output (L/minute) Wait list time (days) a
LVAD Group (n ¼ 2,561)
MD Group (n ¼ 4,737)
p Value
52.7 12.1 2,046 (79.89) 27.8 5.0 802 (31.32) 848 (33.11) 28.9 11.1 1.3 0.9 4.6 1.46
52.5 12.9 3,348 (70.67) 26.5 5.3 1250 (26.38) 1878 (39.65) 28.9 9.9 1.4 0.8 4.42 1.49
0.560 <0.001 <0.001 <0.001 <0.001 0.987 0.002 <0.001
164.47 200.32
131.39 215.08
<0.001
Data are presented as the mean standard deviation or n (%).
BMI ¼ body mass index; PAP ¼ mean pulmonary arterial pressure; UNOS ¼ United Network of Organ Sharing.
as an extended-criteria organ. Only 10.34% (n ¼ 490) of patients who received a marginal donor organ had both BMI mismatch and donor history of cocaine use. Not surprisingly, only 7.45% (n ¼ 353) of marginal donors were greater than 55 years of age and 3.97% (n ¼ 108) had an ejection fraction less than 0.45. Post-transplantation survival analysis for recipients of non-marginal and marginal donor organs who did not receive an LVAD while on the waiting list demonstrated that recipients of marginal donor organs had worse survival at 3 years (p ¼ 0.011). Wait list survival for the LVAD and post-transplant survival for the MD group is shown in Figure 3. The 30-day, 1-year, and 2-year survival in the LVAD group was 96%, 89%, and 85%, respectively, and was similar to the survival in the MD group of 97%, 89%, and 85% (p ¼ 0.213). Post-transplant survival analysis of the MD group showed that patients with 2 or more marginal donor characteristics had Table 2. Breakdown of Diagnosis at Time of Listing for Left Ventricular Assist Device (LVAD) and Marginal Donor (MD) Groupa
Diagnosis Congenital heart defect Coronary artery disease Dilated myopathy: idiopathic Dilated myopathy: ischemic Dilated myopathy: other Re-transplant Hypertrophic cardiomyopathy Restrictive myopathy Valvular disease a
Data are presented as n (%).
LVAD Group (n ¼ 2,561)
MD Group (n ¼ 4,737)
p Value
186 (3.93) 98 (2.07) 1,583 (33.42)
12 (0.47) 78 (3.05) 1,011 (39.48)
<0.0001 <0.0001 <0.0001
1,643 (34.68)
1,044 (40.77)
<0.0001
593 (12.52)
364 (14.21)
<0.0001
219 (4.62) 121 (2.55)
5 (0.20) 13 (0.51)
<0.0001 <0.0001
178 (3.76) 115 (2.43)
12 (0.47) 21 (0.82)
<0.0001 <0.0001
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comparable survival with patients with 1 marginal donor characteristic (p ¼ 0.063). Comparison of survival post-transplantation between the LVAD and MD groups is shown in Figure 4. There was no difference in survival between groups at 3 years post-transplant (p ¼ 0.914).
Comment While the number of patients with advanced heart failure is increasing, donor organ supply has remained stagnant [2]. This has led to the increased use of LVADs for BTT and similarly to the use of extended-criteria donor organs as a method to allow patients to survive until transplant with a reasonable quality of life and receive an adequate donor heart in a timely fashion. While both of these therapies have achieved these respective goals, the survival outcomes between these two therapies have not been specifically compared. Our study groups were similarly distributed in terms of age and pulmonary artery pressure, but differed significantly for sex, BMI, diabetes, UNOS status, creatinine, cardiac output, and wait list time. Dilated cardiomyopathies from all causes comprised the major etiology for each group. Marginal donor characteristics of BMI mismatch greater than 20% and donor history of cocaine use made up 89% of the patient population who received a marginal heart. Although previously considered donor risk factors for poor outcomes, better management of pulmonary hypertension, and awareness of the effects of cocaine on a donor heart have diminished the concern and clinical effect of these 2 “marginal” donor characteristics [14]. The use of extended-criteria donor organs for heart transplantation has allowed expansion of the donor organ pool, but long-term outcomes are unclear. Several studies have shown that the use of marginal organs is associated with “acceptable” patient outcomes, but typically for select patient populations. Bruschi and colleagues [15] conclude in their large retrospective review of 761 patients that donor age 60 years or greater is possible but only after a cardiac angiogram and a detailed risk assessment have been performed. Forni and colleagues [16], using marginal inclusion criteria of age greater than 45 years, high-dose inotropic support, left ventricular hypertrophy, hepatitis B and C infection, coronary artery disease, chest trauma, size mismatch, donor history of drug abuse, or tumor, found no significant difference in survival between recipients of optimal and marginal donor hearts when stratified by recipient age. However, they noted that improved outcomes are observed for all patients who underwent transplantation with an optimal donor heart regardless of recipient age. Conversely, there is evidence of increased rates of primary graft failure and mortality in heart transplant recipients of marginal donor organs [17]. This is supported by our study findings that survival is worse in recipients of marginal donor organs when compared with optimal donor organs. Donor characteristics contribute to the incidence of primary graft failure as demonstrated by
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Russo and colleagues [18] in a large review of the UNOS database. In a retrospective, single-center analysis, Topkara and colleagues [19] demonstrated that donor age is an independent predictor of recipient survival. Fiorelli and colleagues [20] made similar conclusions in their multi-institutional study of over 500 patients. In an analysis of the UNOS database, Khush and colleagues [21] found a strong relationship between both sex and size mismatch and post-transplantation survival. This was also demonstrated in select patient populations in a separate UNOS database analysis performed by Patel and colleagues [22]. Daneshmand and colleagues [12] presented a study with results similar to ours in 2010, comparing survival outcomes in patients with destination LVAD therapy and
patients who received an extended-criteria donor heart for transplantation. This was a single-institution study using organs that had been turned down by all other centers citing decreased left ventricular function, left ventricular hypertrophy, and coronary artery disease as the most common reasons for organ refusal. They found similar 1-year mortality for these 2 patient populations and similar 3-year survival when patients receiving older pulsatile pump technology were excluded. They concluded that destination LVAD therapy was an equivalent option for advanced heart failure compared with waiting for an extended criteria donor heart. Williams and colleagues [23] have also previously demonstrated that survival, readmissions, and costs were similar out to 1 year when comparing LVADs to heart transplantation.
Table 3. Breakdown of Marginal Donor Group by Marginal Characteristicsa Marginal Characteristic
n (%)
Age Age & BMI Age & BMI & cocaine Age & cocaine Age & EF BMI BMI & cocaine BMI & cocaine & EF BMI & EF Cocaine Cocaine & EF EF Total a
208 120 10 13 2 2,836 490 5 58 872 14 109 4,737
(4.39) (2.53) (0.21) (0.27) (0.04) (59.87) (10.34) (0.11) (1.22) (18.41) (0.30) (2.30) (100)
Data are presented as n (%).
BMI ¼ body mass index;
EF ¼ ejection fraction less than 0.45.
Fig 3. Kaplan-Meier survival analysis comparing all-cause mortality for continuous flow left ventricular assist device (LVAD) pretransplant recipients and recipients of marginal donor hearts posttransplantation.
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Fig 2. Annual case count from 2005 to 2013 for left ventricular assist device (LVAD) placement and marginal donor heart transplantations. The LVAD cases are counted at time of listing while marginal donor heart transplantations are counted at time of transplant.
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management are key components to achieving acceptable outcomes. While the use of marginal donor organs does present an opportunity to expand the donor organ pool, we must first adopt standard criteria for a “marginal” organ and then determine appropriate patients to receive these “marginal” hearts. Conversely, LVAD support prior to heart transplantation may offer improved survival outcomes pre-transplantation and post-transplantation [4, 9] but will also allow additional time for better allocation of optimal donor heart for better outcomes. Given that there is evidence for poor patient outcomes after heart transplantation with a marginal donor organ, our study suggests that additional consideration should be given to using an LVAD as BTT to allow transplantation with an optimal donor organ for best long-term patient outcomes. Fig 4. Kaplan-Meier survival analysis comparing all-cause mortality for post-transplantation survival for patients implanted with a left ventricular assist device (LVAD) and recipients of marginal donor hearts.
Our data showed similar survival of LVAD patients while on the wait list compared with post-transplant survival of patients who received a marginal donor organ. Additionally, post-transplant survival was worse for recipients of marginal donor hearts than for recipients of non-marginal hearts. Our group has also previously reported that continuous-flow LVAD pre-transplant placement is associated with improved long-term (>1 year) survival after heart transplantation [9]. These results suggest the use of LVAD as BTT could be beneficial in allowing more time for better allocation of an optimal donor heart. Both the term “marginal” donor heart and the optimal use of marginal hearts in specific recipients needs to be better defined. As LVAD technology continues to improve, the survival of BTT patients on the waiting list and their post-transplant survival will also improve over time. Our study has limitations. We chose the study time period because the convention was to place patients on the UNOS waiting list within 48 hours of LVAD implantation, thus resulting in a disproportionate distribution of transplant patients in earlier years compared with LVAD patients. Unfortunately, the date of LVAD implantation is not directly available due to database limitations that forced us to make this assumption when designing this study. Additionally, our list of marginal donor characteristics is not all-inclusive nor is there an accepted definition of what is considered a marginal donor organ. Therefore, we chose marginal donor characteristics based on current literature [5]. This is also a retrospective study; selection bias of transplant recipients of each group exists. In summary, patients implanted with continuous-flow LVAD as BTT have similar survival out to 3 years compared with patients who received an extended-criteria donor heart for transplantation. Although there is some evidence in favor of using marginal donor organs for transplantation, patient selection and rigorous donor
References 1. Go AS, Mozaffarian D, Roger VL, et al. Executive summary: heart disease and stroke statistics–2014 update: a report from the American Heart Association. Circulation 2014;129: 399–410. 2. Colvin-Adams M, Smithy JM, Heubner BM, et al. OPTN/ SRTR 2012 Annual Data Report: heart. Am J Transplant 2014;14(Suppl 1):113–38. 3. Kirklin JK, Naftel DC, Pagani FD, et al. Sixth INTERMACS annual report: a 10,000-patient database. J Heart Lung Transplant 2014;33:555–64. 4. Trivedi JR, Cheng A, Singh R, Williams ML, Slaughter MS. Survival on the heart transplant waiting list: impact of continuous flow left ventricular assist device as bridge to transplant. Ann Thorac Surg 2014;98:830–4. 5. Russo MJ, Davies RR, Hong KN, et al. Matching high-risk recipients with marginal donor hearts is a clinically effective strategy. Ann Thorac Surg 2009;87:1066–71. 6. Kransdorf EP, Stehlik J. Donor evaluation in heart transplantation: the end of the beginning. J Heart Lung Transplant 2014;33:1105–13. 7. Felker GM, Milano CA, Yager JE, et al. Outcomes with an alternate list strategy for heart transplantation. J Heart Lung Transplant 2005;24:1781–6. 8. Chen JM, Russo MJ, Hammond KM, et al. Alternate waiting list strategies for heart transplantation maximize donor organ utilization. Ann Thorac Surg 2005;80:224–8. 9. Donneyong M, Cheng A, Trivedi JR, et al. The association of pretransplant HeartMate II left ventricular assist device placement and heart transplantation mortality. ASAIO J 2014;60:294–9. 10. Slaughter MS, Pagani FD, McGee EC, et al. HeartWare ventricular assist system for bridge to transplant: combined results of the bridge to transplant and continued access protocol trial. J Heart Lung Transplant 2013;32:675–83. 11. Starling RC, Naka Y, Boyle AJ, et al. Results of the post-U.S. Food and Drug Administration–approval study with a continuous flow left ventricular assist device as a bridge to heart transplantation: a prospective study using the INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support). J Am Coll Cardiol 2011;57:1890–8. 12. Daneshmand MA, Rajagopal K, Lima B, et al. Left ventricular assist device destination therapy versus extended criteria cardiac transplant. Ann Thorac Surg 2010;89:1205–10. 13. Forni A, Luciani GB, Chiominto B, Pizzuti M, Mazzucco A, Faggian G. Results with expanded donor acceptance criteria in heart transplantation. Transplant Proc 2011;43:953–9. 14. Brieke A, Krishnamani R, Rocha MJ, et al. Influence of donor cocaine use on outcome after cardiac transplantation: analysis of the United Network for Organ Sharing Thoracic Registry. J Heart Lung Transplant 2008;27:1350–2.
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20. Fiorelli AI, Branco JN, Dinkhuysen JJ, et al. Risk factor analysis of late survival after heart transplantation according to donor profile: a multi-institutional retrospective study of 512 transplants. Transplant Proc 2012;44:2469–72. 21. Khush KK, Kubo JT, Desai M. Influence of donor and recipient sex mismatch on heart transplant outcomes: analysis of the International Society for Heart and Lung Transplantation Registry. J Heart Lung Transplant 2012;31:459–66. 22. Patel ND, Weiss ES, Nwakanma LU, et al. Impact of donorto-recipient weight ratio on survival after heart transplantation: analysis of the United Network for Organ Sharing Database. Circulation 2008;118(14 Suppl):S83–8. 23. Williams ML, Trivedi JR, McCants KC, et al. Heart transplant vs left ventricular assist device in heart transplant-eligible patients. Ann Thorac Surg 2011;91:1330–4.
DISCUSSION DR JAMES K. KIRKLIN (Birmingham, AL): First, I would like to congratulate you on a very nice presentation. This is a rather complicated analysis to perform as you are trying to approximate truth, yet you are the one sitting there with a patient who is deteriorating and you are trying to help better understand which of your 2 strategies would give the patient the best chance for post-transplant survival. So I have 2 questions for you. The first relates to the analysis. As I understand your presentation, in the VAD [ventricular assist device] group you restricted your analysis to the time on the waiting list with censoring at transplantation. I wonder if it might have been a more effective analysis if you included posttransplant survival in the VAD group, since the overall objective was to maximize survival following cardiac transplantation rather than survival to transplant on the wait list. DR SCHUMER: Thank you, Dr Kirklin. I think that is a great point. However, this was an intention-to-treat analysis, and so for the LVAD [left VAD] group our treatment was considered as LVAD implantation, not receiving a transplant, and then for the marginal donor group, it was receiving a transplant. The aim of the study intentionally excluded post-transplant survival for patients who received an LVAD. There have also been several papers published recently that demonstrate equivalent or improved survival for patients who received an LVAD post-transplant compared with those who did not have an LVAD post-transplant. Since this is not new information, we again decided to exclude this survival analysis from our study. DR KIRKLIN: Okay. Another question relates to our interest in drawing inferences from your analysis, and so I wonder if you would comment about how your analysis has affected your own clinical practice. For example, in a deteriorating patient would you generally recommend a VAD as bridge to transplant therapy as opposed to accepting on the spot a donor who was fulfilling some of your extended donor criteria? For example, if you had a 67-year-old man who was deteriorating on the list
and an extended donor becomes available, would you elect to put a VAD in that patient or accept a donor heart that is otherwise normal but the donor age was, say, 57? Or, for example, in an elderly patient who is deteriorating, would you recommend a mechanical circulatory support device rather than accepting an extended donor for whom the criteria was a normal heart but, say, 30% less body mass index than the proposed recipient? DR SCHUMER: That is a very complicated question and it probably is somewhat physician dependent. Our study really addresses not the deteriorating patient who is waiting for a heart. It looks more at a patient who is stable at home with an LVAD, should you take a marginal donor heart for that patient, and the answer, based on our analysis, is probably not. Now, for the deteriorating patient, it probably would be better to take that marginal donor heart if they are in the hospital and doing poorly. DR SLAUGHTER: Dr Kirklin raises some very important clinical issues, and I think the one that we struggle with and he alludes to is what really is a marginal donor, because a marginal donor implies that you will get less than an optimal outcome. So in those patients that are acutely ill and deteriorating, assuming you have an adequate organ that would give you adequate 5- and 10-year survival, we would certainly use the “marginal donor,” because right now I think we would all agree that although we have good 2 to 3 years’ outcomes with VADs, the 5- to 10-year outcome is still unclear. So with an acceptable donor organ, we would certainly prefer to actually transplant the patient. I think the dilemma becomes with all these patients that are stable 1B on a VAD: Do we need to accept something that truly might compromise a 10-year survival versus waiting for what might be a more optimal organ? In these transitioning times of matching donors to recipients to optimize long-term transplant outcomes, we hope that with improving VAD outcomes we will be able to answer that question in the next few years.
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15. Bruschi G, Colombo T, Oliva F, et al. Orthotopic heart transplantation with donors greater than or equal to 60 years of age: a single-center experience. Eur J Cardiothorac Surg 2011;40:e55–61. 16. Forni A, Luciani GB, Chiominto B, Pilati M, Mazzucco A, Faggian G. Impact of donor quality on outcome of heart transplantation. Eur J Cardiothorac Surg 2010;38:788–94. 17. Iyer A, Kumarasinghe G, Hicks M, et al. Primary graft failure after heart transplantation. J Transplant 2011;2011:175768. 18. Russo MJ, Iribarne A, Hong KN, et al. Factors associated with primary graft failure after heart transplantation. Transplantation 2010;90:444–50. 19. Topkara VK, Cheema FH, Kesavaramanujam S, et al. Effect of donor age on long-term survival following cardiac transplantation. J Card Surg 2006;21:125–9.
SCHUMER ET AL MARGINAL DONOR HEARTS COMPARED WITH LVADS
Early Outcomes With Marginal Donor Hearts Compared With Left Ventricular Assist Device Support in Patients With Advanced Heart Failure Erin M. Schumer, MD,* Mickey S. Ising, MEng,* Jaimin R. Trivedi, MD, MPH, Mark S. Slaughter, MD, and Allen Cheng, MD Department of Cardiovascular and Thoracic Surgery, University of Louisville, Louisville, Kentucky
Background. The shortage of donor hearts has limited cardiac transplantation for end-stage heart failure, leading to the increased use of left ventricular assist devices (LVADs) as bridge-to-transplant (BTT) and marginal donor hearts; however, outcomes have been mixed. This study examines differences in wait list survival of patients with continuous flow LVADs and post-transplantation survival of patients receiving a marginal donor heart. Methods. The United Network of Organ Sharing database was retrospectively queried from January 2005 to June 2013 to identify adult patients listed for heart transplant. Marginal donor criteria included age greater than 55 years, hepatitis C positive, cocaine use, ejection fraction less than 0.45, or donor to recipient body mass index mismatch of greater than 20%. The primary endpoint was wait list survival of patients with LVADs compared with post-transplant survival of marginal donor heart recipients using Kaplan-Meier analysis.
Results. A total of 2,561 and 4,737 patients received LVAD support or a marginal donor heart, respectively. The 30-day, 1-year, and 2-year survival was 96%, 89%, and 85%, for patients with LVAD support on the waiting list and 97%, 89%, and 85%, respectively, for recipients of marginal donor hearts (p [ 0.213). Recipients of marginal hearts had worse survival than non-marginal heart recipients at 3 years (p [ 0.011). Conclusions. There was no significant difference between waiting list survival of patients with LVAD support as BTT and post-transplant survival of recipients with marginal donor hearts. There could be clinical benefits for using LVAD support as BTT to allow time for better allocation of optimal donor hearts as opposed to transplantation with a marginal donor heart.
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mismatch greater than 20% [5, 6]. Survival outcomes are generally worse for recipients of marginal donor hearts by up to 20% at 5 years although there is evidence of similar early outcomes [7, 8]. Alternatively, outcomes for patients receiving contemporary continuous flow LVADs as support for BTT have been associated with improved patient survival and are not limited by supply [4, 9–11]. While LVADs as BTT and the use of marginal donor hearts have expanded treatment options for patients with ESHD, the best treatment option and long-term survival outcomes remain unclear [12, 13]. In an effort to help improve the decision-making process, we used the United Organ Sharing Network (UNOS) database to evaluate potential survival differences between patients on the waiting list with a contemporary continuous flow LVAD compared with heart transplant recipients of extended-criteria donor hearts.
nd-stage heart disease (ESHD) currently affects 5.1 million people in the United States with an estimated growth in incidence of 25% by 2030 [1]. Heart transplantation remains the gold standard treatment for patients with ESHD; however, the supply of donor organs remains limited [2]. This limited supply of appropriate donor organs has led to the development and increased use left ventricular assist devices (LVADs) as bridge-totransplant (BTT) therapy [1–4]. Simultaneously, marginal or “extended-criteria” donor organs are being used in an effort to increase the donor organ pool [2]. While no standardized criteria exist, general consensus in the literature indicates that a donor organ is considered marginal when the donor has the following characteristics: age greater than 55 years old; hepatitis C positive; cocaine use; ejection fraction less than 0.45; or donor to recipient body mass index (BMI) Accepted for publication Feb 19, 2015. *Erin Schumer and Mickey Ising contributed equally to the study. Presented at the Sixty-first Annual Meeting of the Southern Thoracic Surgical Association, Tucson, AZ, Nov 5–8, 2014. Address correspondence to Dr Cheng, University of Louisville, Department of Thoracic and Cardiovascular Surgery, 201 Abraham Flexner Way, Ste 1200, Louisville, KY 40202; e-mail: [email protected].
Ó 2015 by The Society of Thoracic Surgeons Published by Elsevier
(Ann Thorac Surg 2015;100:522–7) Ó 2015 by The Society of Thoracic Surgeons
Patients and Methods Data were obtained from the UNOS registry for patients listed for heart transplantation from January 2005 through June 2013. The entire UNOS registry for this time period consisted of 136,498 patients. Patients were included in the study if they were listed for heart transplantation, 0003-4975/$36.00 http://dx.doi.org/10.1016/j.athoracsur.2015.02.089
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A p value of 0.05 or less was considered statistically significant.
Results Analysis included a total of 7,298 patients divided into 2 groups. There were 2,561 patients in the LVAD group and 4,737 patients in the MD group. Similar baseline preoperative characteristics for both groups included age and pulmonary artery pressure; however, the proportion of males and diabetics, BMI, cardiac output, and wait list time were higher for the LVAD group. The MD group had a higher proportion of patients listed as UNOS status IA and higher creatinine. Demographic information for both groups is summarized in Table 1. Dilated cardiomyopathy due to all causes was the most common etiology of heart failure in both groups; 3,819 (80.62%) for the MD group and 2,419 (94.46%) for the LVAD group. The distribution of diagnoses for heart failure is shown in Table 2. The proportion of diagnoses was markedly different for these 2 populations for all diagnoses. Annual case distribution for 2005 to 2013 is shown in Figure 2 and reflects the number of LVADs placed at time of listing and marginal donor hearts at time of transplant. With the exception of 2005 and 2013, the number of marginal donor heart transplantations remained similar. The MD group was then further classified by marginal donor characteristics (Table 3). The BMI mismatch and donor history of cocaine use, respectively, accounted for 59.87% (n ¼ 2,836) and 18.41% (n ¼ 872) for classification
Fig 1. Flow chart of selection of patients for analysis using the United Network for Organ Sharing database. The left-ventricular assist device group, n ¼ 2,561; marginal donor group, n ¼ 4,737. (HMII ¼ HeartMate II; HVAD ¼ heart ventricular assist device; MCS ¼ mechanical circulatory support device.)
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were 18 or greater years old, and listed after December 31, 2004 (n ¼ 24,039). Patients were excluded if the wait list criteria were listed as refused transplantation, transferred to another center, other, condition improved, too ill for transplant, removed in error, emergency transplantation, died during transplantation, or unable to contact. The study population was then divided into 2 groups. Patients in the LVAD group were included if they received a continuous flow LVAD, either HeartMate II (Thoratec, Pleasanton, CA) or HVAD (Heartware, Inc, Miami Lakes, FL) at time of listing (n ¼ 2,561). The marginal donor (MD) group includes patients who underwent heart transplantation without ever having received an LVAD and underwent transplantation with a marginal donor heart (n ¼ 4,737). Marginal donor criteria included age greater than 55 years old, hepatitis C positive, cocaine use, ejection fraction less than 0.45, or donor to recipient (BMI) greater mismatch of 20%) [5, 6]. The full algorithm for the study design is shown in Figure 1. The primary outcome of this study was comparison of survival between patients on the waiting list with a continuous flow LVAD and patients transplanted with a marginal donor heart. All statistical analyses were completed using SPSS v. 22 (IBM, Armonk, NY). All reported results are at time of LVAD implantation for the LVAD group and time of transplantation for the MD group. The Student t test and c2 analysis were used to compare study group characteristics. Kaplan-Meier survival analysis was used to compare survival between study groups. Values are report as n (percent) or average standard deviation.
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Table 1. Characteristics of the Left Ventricular Assist Device (LVAD) Group and Marginal Donor (MD) Heart Groupa
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Characteristic Age (years) Sex (male) BMI Diabetes UNOS status IA PAP (mm Hg) Creatinine Cardiac output (L/minute) Wait list time (days) a
LVAD Group (n ¼ 2,561)
MD Group (n ¼ 4,737)
p Value
52.7 12.1 2,046 (79.89) 27.8 5.0 802 (31.32) 848 (33.11) 28.9 11.1 1.3 0.9 4.6 1.46
52.5 12.9 3,348 (70.67) 26.5 5.3 1250 (26.38) 1878 (39.65) 28.9 9.9 1.4 0.8 4.42 1.49
0.560 <0.001 <0.001 <0.001 <0.001 0.987 0.002 <0.001
164.47 200.32
131.39 215.08
<0.001
Data are presented as the mean standard deviation or n (%).
BMI ¼ body mass index; PAP ¼ mean pulmonary arterial pressure; UNOS ¼ United Network of Organ Sharing.
as an extended-criteria organ. Only 10.34% (n ¼ 490) of patients who received a marginal donor organ had both BMI mismatch and donor history of cocaine use. Not surprisingly, only 7.45% (n ¼ 353) of marginal donors were greater than 55 years of age and 3.97% (n ¼ 108) had an ejection fraction less than 0.45. Post-transplantation survival analysis for recipients of non-marginal and marginal donor organs who did not receive an LVAD while on the waiting list demonstrated that recipients of marginal donor organs had worse survival at 3 years (p ¼ 0.011). Wait list survival for the LVAD and post-transplant survival for the MD group is shown in Figure 3. The 30-day, 1-year, and 2-year survival in the LVAD group was 96%, 89%, and 85%, respectively, and was similar to the survival in the MD group of 97%, 89%, and 85% (p ¼ 0.213). Post-transplant survival analysis of the MD group showed that patients with 2 or more marginal donor characteristics had Table 2. Breakdown of Diagnosis at Time of Listing for Left Ventricular Assist Device (LVAD) and Marginal Donor (MD) Groupa
Diagnosis Congenital heart defect Coronary artery disease Dilated myopathy: idiopathic Dilated myopathy: ischemic Dilated myopathy: other Re-transplant Hypertrophic cardiomyopathy Restrictive myopathy Valvular disease a
Data are presented as n (%).
LVAD Group (n ¼ 2,561)
MD Group (n ¼ 4,737)
p Value
186 (3.93) 98 (2.07) 1,583 (33.42)
12 (0.47) 78 (3.05) 1,011 (39.48)
<0.0001 <0.0001 <0.0001
1,643 (34.68)
1,044 (40.77)
<0.0001
593 (12.52)
364 (14.21)
<0.0001
219 (4.62) 121 (2.55)
5 (0.20) 13 (0.51)
<0.0001 <0.0001
178 (3.76) 115 (2.43)
12 (0.47) 21 (0.82)
<0.0001 <0.0001
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comparable survival with patients with 1 marginal donor characteristic (p ¼ 0.063). Comparison of survival post-transplantation between the LVAD and MD groups is shown in Figure 4. There was no difference in survival between groups at 3 years post-transplant (p ¼ 0.914).
Comment While the number of patients with advanced heart failure is increasing, donor organ supply has remained stagnant [2]. This has led to the increased use of LVADs for BTT and similarly to the use of extended-criteria donor organs as a method to allow patients to survive until transplant with a reasonable quality of life and receive an adequate donor heart in a timely fashion. While both of these therapies have achieved these respective goals, the survival outcomes between these two therapies have not been specifically compared. Our study groups were similarly distributed in terms of age and pulmonary artery pressure, but differed significantly for sex, BMI, diabetes, UNOS status, creatinine, cardiac output, and wait list time. Dilated cardiomyopathies from all causes comprised the major etiology for each group. Marginal donor characteristics of BMI mismatch greater than 20% and donor history of cocaine use made up 89% of the patient population who received a marginal heart. Although previously considered donor risk factors for poor outcomes, better management of pulmonary hypertension, and awareness of the effects of cocaine on a donor heart have diminished the concern and clinical effect of these 2 “marginal” donor characteristics [14]. The use of extended-criteria donor organs for heart transplantation has allowed expansion of the donor organ pool, but long-term outcomes are unclear. Several studies have shown that the use of marginal organs is associated with “acceptable” patient outcomes, but typically for select patient populations. Bruschi and colleagues [15] conclude in their large retrospective review of 761 patients that donor age 60 years or greater is possible but only after a cardiac angiogram and a detailed risk assessment have been performed. Forni and colleagues [16], using marginal inclusion criteria of age greater than 45 years, high-dose inotropic support, left ventricular hypertrophy, hepatitis B and C infection, coronary artery disease, chest trauma, size mismatch, donor history of drug abuse, or tumor, found no significant difference in survival between recipients of optimal and marginal donor hearts when stratified by recipient age. However, they noted that improved outcomes are observed for all patients who underwent transplantation with an optimal donor heart regardless of recipient age. Conversely, there is evidence of increased rates of primary graft failure and mortality in heart transplant recipients of marginal donor organs [17]. This is supported by our study findings that survival is worse in recipients of marginal donor organs when compared with optimal donor organs. Donor characteristics contribute to the incidence of primary graft failure as demonstrated by
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Russo and colleagues [18] in a large review of the UNOS database. In a retrospective, single-center analysis, Topkara and colleagues [19] demonstrated that donor age is an independent predictor of recipient survival. Fiorelli and colleagues [20] made similar conclusions in their multi-institutional study of over 500 patients. In an analysis of the UNOS database, Khush and colleagues [21] found a strong relationship between both sex and size mismatch and post-transplantation survival. This was also demonstrated in select patient populations in a separate UNOS database analysis performed by Patel and colleagues [22]. Daneshmand and colleagues [12] presented a study with results similar to ours in 2010, comparing survival outcomes in patients with destination LVAD therapy and
patients who received an extended-criteria donor heart for transplantation. This was a single-institution study using organs that had been turned down by all other centers citing decreased left ventricular function, left ventricular hypertrophy, and coronary artery disease as the most common reasons for organ refusal. They found similar 1-year mortality for these 2 patient populations and similar 3-year survival when patients receiving older pulsatile pump technology were excluded. They concluded that destination LVAD therapy was an equivalent option for advanced heart failure compared with waiting for an extended criteria donor heart. Williams and colleagues [23] have also previously demonstrated that survival, readmissions, and costs were similar out to 1 year when comparing LVADs to heart transplantation.
Table 3. Breakdown of Marginal Donor Group by Marginal Characteristicsa Marginal Characteristic
n (%)
Age Age & BMI Age & BMI & cocaine Age & cocaine Age & EF BMI BMI & cocaine BMI & cocaine & EF BMI & EF Cocaine Cocaine & EF EF Total a
208 120 10 13 2 2,836 490 5 58 872 14 109 4,737
(4.39) (2.53) (0.21) (0.27) (0.04) (59.87) (10.34) (0.11) (1.22) (18.41) (0.30) (2.30) (100)
Data are presented as n (%).
BMI ¼ body mass index;
EF ¼ ejection fraction less than 0.45.
Fig 3. Kaplan-Meier survival analysis comparing all-cause mortality for continuous flow left ventricular assist device (LVAD) pretransplant recipients and recipients of marginal donor hearts posttransplantation.
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Fig 2. Annual case count from 2005 to 2013 for left ventricular assist device (LVAD) placement and marginal donor heart transplantations. The LVAD cases are counted at time of listing while marginal donor heart transplantations are counted at time of transplant.
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management are key components to achieving acceptable outcomes. While the use of marginal donor organs does present an opportunity to expand the donor organ pool, we must first adopt standard criteria for a “marginal” organ and then determine appropriate patients to receive these “marginal” hearts. Conversely, LVAD support prior to heart transplantation may offer improved survival outcomes pre-transplantation and post-transplantation [4, 9] but will also allow additional time for better allocation of optimal donor heart for better outcomes. Given that there is evidence for poor patient outcomes after heart transplantation with a marginal donor organ, our study suggests that additional consideration should be given to using an LVAD as BTT to allow transplantation with an optimal donor organ for best long-term patient outcomes. Fig 4. Kaplan-Meier survival analysis comparing all-cause mortality for post-transplantation survival for patients implanted with a left ventricular assist device (LVAD) and recipients of marginal donor hearts.
Our data showed similar survival of LVAD patients while on the wait list compared with post-transplant survival of patients who received a marginal donor organ. Additionally, post-transplant survival was worse for recipients of marginal donor hearts than for recipients of non-marginal hearts. Our group has also previously reported that continuous-flow LVAD pre-transplant placement is associated with improved long-term (>1 year) survival after heart transplantation [9]. These results suggest the use of LVAD as BTT could be beneficial in allowing more time for better allocation of an optimal donor heart. Both the term “marginal” donor heart and the optimal use of marginal hearts in specific recipients needs to be better defined. As LVAD technology continues to improve, the survival of BTT patients on the waiting list and their post-transplant survival will also improve over time. Our study has limitations. We chose the study time period because the convention was to place patients on the UNOS waiting list within 48 hours of LVAD implantation, thus resulting in a disproportionate distribution of transplant patients in earlier years compared with LVAD patients. Unfortunately, the date of LVAD implantation is not directly available due to database limitations that forced us to make this assumption when designing this study. Additionally, our list of marginal donor characteristics is not all-inclusive nor is there an accepted definition of what is considered a marginal donor organ. Therefore, we chose marginal donor characteristics based on current literature [5]. This is also a retrospective study; selection bias of transplant recipients of each group exists. In summary, patients implanted with continuous-flow LVAD as BTT have similar survival out to 3 years compared with patients who received an extended-criteria donor heart for transplantation. Although there is some evidence in favor of using marginal donor organs for transplantation, patient selection and rigorous donor
References 1. Go AS, Mozaffarian D, Roger VL, et al. Executive summary: heart disease and stroke statistics–2014 update: a report from the American Heart Association. Circulation 2014;129: 399–410. 2. Colvin-Adams M, Smithy JM, Heubner BM, et al. OPTN/ SRTR 2012 Annual Data Report: heart. Am J Transplant 2014;14(Suppl 1):113–38. 3. Kirklin JK, Naftel DC, Pagani FD, et al. Sixth INTERMACS annual report: a 10,000-patient database. J Heart Lung Transplant 2014;33:555–64. 4. Trivedi JR, Cheng A, Singh R, Williams ML, Slaughter MS. Survival on the heart transplant waiting list: impact of continuous flow left ventricular assist device as bridge to transplant. Ann Thorac Surg 2014;98:830–4. 5. Russo MJ, Davies RR, Hong KN, et al. Matching high-risk recipients with marginal donor hearts is a clinically effective strategy. Ann Thorac Surg 2009;87:1066–71. 6. Kransdorf EP, Stehlik J. Donor evaluation in heart transplantation: the end of the beginning. J Heart Lung Transplant 2014;33:1105–13. 7. Felker GM, Milano CA, Yager JE, et al. Outcomes with an alternate list strategy for heart transplantation. J Heart Lung Transplant 2005;24:1781–6. 8. Chen JM, Russo MJ, Hammond KM, et al. Alternate waiting list strategies for heart transplantation maximize donor organ utilization. Ann Thorac Surg 2005;80:224–8. 9. Donneyong M, Cheng A, Trivedi JR, et al. The association of pretransplant HeartMate II left ventricular assist device placement and heart transplantation mortality. ASAIO J 2014;60:294–9. 10. Slaughter MS, Pagani FD, McGee EC, et al. HeartWare ventricular assist system for bridge to transplant: combined results of the bridge to transplant and continued access protocol trial. J Heart Lung Transplant 2013;32:675–83. 11. Starling RC, Naka Y, Boyle AJ, et al. Results of the post-U.S. Food and Drug Administration–approval study with a continuous flow left ventricular assist device as a bridge to heart transplantation: a prospective study using the INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support). J Am Coll Cardiol 2011;57:1890–8. 12. Daneshmand MA, Rajagopal K, Lima B, et al. Left ventricular assist device destination therapy versus extended criteria cardiac transplant. Ann Thorac Surg 2010;89:1205–10. 13. Forni A, Luciani GB, Chiominto B, Pizzuti M, Mazzucco A, Faggian G. Results with expanded donor acceptance criteria in heart transplantation. Transplant Proc 2011;43:953–9. 14. Brieke A, Krishnamani R, Rocha MJ, et al. Influence of donor cocaine use on outcome after cardiac transplantation: analysis of the United Network for Organ Sharing Thoracic Registry. J Heart Lung Transplant 2008;27:1350–2.
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20. Fiorelli AI, Branco JN, Dinkhuysen JJ, et al. Risk factor analysis of late survival after heart transplantation according to donor profile: a multi-institutional retrospective study of 512 transplants. Transplant Proc 2012;44:2469–72. 21. Khush KK, Kubo JT, Desai M. Influence of donor and recipient sex mismatch on heart transplant outcomes: analysis of the International Society for Heart and Lung Transplantation Registry. J Heart Lung Transplant 2012;31:459–66. 22. Patel ND, Weiss ES, Nwakanma LU, et al. Impact of donorto-recipient weight ratio on survival after heart transplantation: analysis of the United Network for Organ Sharing Database. Circulation 2008;118(14 Suppl):S83–8. 23. Williams ML, Trivedi JR, McCants KC, et al. Heart transplant vs left ventricular assist device in heart transplant-eligible patients. Ann Thorac Surg 2011;91:1330–4.
DISCUSSION DR JAMES K. KIRKLIN (Birmingham, AL): First, I would like to congratulate you on a very nice presentation. This is a rather complicated analysis to perform as you are trying to approximate truth, yet you are the one sitting there with a patient who is deteriorating and you are trying to help better understand which of your 2 strategies would give the patient the best chance for post-transplant survival. So I have 2 questions for you. The first relates to the analysis. As I understand your presentation, in the VAD [ventricular assist device] group you restricted your analysis to the time on the waiting list with censoring at transplantation. I wonder if it might have been a more effective analysis if you included posttransplant survival in the VAD group, since the overall objective was to maximize survival following cardiac transplantation rather than survival to transplant on the wait list. DR SCHUMER: Thank you, Dr Kirklin. I think that is a great point. However, this was an intention-to-treat analysis, and so for the LVAD [left VAD] group our treatment was considered as LVAD implantation, not receiving a transplant, and then for the marginal donor group, it was receiving a transplant. The aim of the study intentionally excluded post-transplant survival for patients who received an LVAD. There have also been several papers published recently that demonstrate equivalent or improved survival for patients who received an LVAD post-transplant compared with those who did not have an LVAD post-transplant. Since this is not new information, we again decided to exclude this survival analysis from our study. DR KIRKLIN: Okay. Another question relates to our interest in drawing inferences from your analysis, and so I wonder if you would comment about how your analysis has affected your own clinical practice. For example, in a deteriorating patient would you generally recommend a VAD as bridge to transplant therapy as opposed to accepting on the spot a donor who was fulfilling some of your extended donor criteria? For example, if you had a 67-year-old man who was deteriorating on the list
and an extended donor becomes available, would you elect to put a VAD in that patient or accept a donor heart that is otherwise normal but the donor age was, say, 57? Or, for example, in an elderly patient who is deteriorating, would you recommend a mechanical circulatory support device rather than accepting an extended donor for whom the criteria was a normal heart but, say, 30% less body mass index than the proposed recipient? DR SCHUMER: That is a very complicated question and it probably is somewhat physician dependent. Our study really addresses not the deteriorating patient who is waiting for a heart. It looks more at a patient who is stable at home with an LVAD, should you take a marginal donor heart for that patient, and the answer, based on our analysis, is probably not. Now, for the deteriorating patient, it probably would be better to take that marginal donor heart if they are in the hospital and doing poorly. DR SLAUGHTER: Dr Kirklin raises some very important clinical issues, and I think the one that we struggle with and he alludes to is what really is a marginal donor, because a marginal donor implies that you will get less than an optimal outcome. So in those patients that are acutely ill and deteriorating, assuming you have an adequate organ that would give you adequate 5- and 10-year survival, we would certainly use the “marginal donor,” because right now I think we would all agree that although we have good 2 to 3 years’ outcomes with VADs, the 5- to 10-year outcome is still unclear. So with an acceptable donor organ, we would certainly prefer to actually transplant the patient. I think the dilemma becomes with all these patients that are stable 1B on a VAD: Do we need to accept something that truly might compromise a 10-year survival versus waiting for what might be a more optimal organ? In these transitioning times of matching donors to recipients to optimize long-term transplant outcomes, we hope that with improving VAD outcomes we will be able to answer that question in the next few years.
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15. Bruschi G, Colombo T, Oliva F, et al. Orthotopic heart transplantation with donors greater than or equal to 60 years of age: a single-center experience. Eur J Cardiothorac Surg 2011;40:e55–61. 16. Forni A, Luciani GB, Chiominto B, Pilati M, Mazzucco A, Faggian G. Impact of donor quality on outcome of heart transplantation. Eur J Cardiothorac Surg 2010;38:788–94. 17. Iyer A, Kumarasinghe G, Hicks M, et al. Primary graft failure after heart transplantation. J Transplant 2011;2011:175768. 18. Russo MJ, Iribarne A, Hong KN, et al. Factors associated with primary graft failure after heart transplantation. Transplantation 2010;90:444–50. 19. Topkara VK, Cheema FH, Kesavaramanujam S, et al. Effect of donor age on long-term survival following cardiac transplantation. J Card Surg 2006;21:125–9.
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