CardioWest total artificial heart: a retrospective controlled study

The CardioWest total artificial heart (TAH) is a pneumatic device that is used as a bridge to heart transplantation and the only TAH available that totally replaces the failing ventricles. It has been utilized in selected centers in the U.S.A. with approval from the Food and Drug Administration. Strict criteria have been developed to select candidates to be bridged with the TAH. The patient must be a heart transplant candidate of age >18 and <59 years with a body surface area (BSA) > or = 1.7 m2, cardiac index (CI) <2.0 L/min/m2, and 2 inotropic agents or 1 plus an intraaortic balloon pump (IABP). A total of 24 heat transplant candidates (Group A) met the entry criteria and underwent placement of the TAH between January 1993 and July 1996. Group A consisted of 23 males; 16 patients had an IABP. The control group (Group B) consisted of 18 heart transplant candidates who met the TAH entry criteria but never received a TAH. Group B consisted of 15 males; 14 patients had an IABP. Preimplantation pulmonary vascular resistance (PVR) (Wood units), serum creatinine (mg/dl), and total bilirubin (mg/dl) were determined in both groups. The mean values for Groups A and B were, respectively, age: 47 and 47 years, BSA: 2.01 and 1.93 m2, CI: 1.5 and 1.8 L/min/m2, PVR: 2.88 and 2.47 Wood units, creatinine: 1.5 and 1.6 mg/dl, and bilirubin: 1.8 and 1.4 mg/dl. In Group A, 1 patient died on the TAH, 1 patient died after transplant, and 22 patients reached transplant and were discharged home for a survival rate of 91.7%. In Group B, 10 patients died while waiting for a heart transplant. Of the 8 patients transplanted, 7 survived and were discharged home for a survival rate of 38.9% (p = 0.0003). In summary the CardioWest TAH provided an excellent and successful method of bridging patients to heart transplantation with a reasonable risk.     

Artificial heart. Management and clinical utilization

The improved results of heart transplantation and the need to support hemodynamically those patients with cardiac failure while waiting for a suitable donor has heralded the development of mechanical ventricular assist pumps and the total artificial heart (TAH) as a bridge to transplantation. There are nowadays several TAH in use. The aim of this paper is to describe the current clinical model of the Utah University (model Jarvik-7) and its present or potential clinical applications and indications for use. The world experience up to August 1988 is reviewed.     

Does the clinical evaluation of the cardiac status predict outcome in patients with abdominal aortic aneurysms?

A cost-effective method to reduce mortality rates after abdominal aortic aneurysm repair centers on selecting and investigating only those patients at risk for cardiac-related death. All 146 patients undergoing asymptomatic abdominal aortic aneurysm repair over a 5-year period (1986 to 1990) were retrospectively placed into one of the three following groups on the basis of a clinical evaluation. Group I: no history of myocardial infarction or angina, no congestive heart failure, and no ischemic changes on electrocardiogram (ECG). Group II: history of myocardial infarction or class I-II angina or ischemic changes on ECG. Group III: presence of congestive heart failure or class III-IV angina. Patients in group I had no further cardiac work-up; patients in group II with angina had left ventricular ejection fraction assessment by multiple gated acquisition (all greater than 37%) and were cleared for operation by a cardiologist; patients in group II without angina had no further cardiac work-up; patients in group III had coronary angiography and then coronary revascularization. The overall mortality rate was 4.8%, with a cardiac mortality rate of 3.4%. The mortality rate in group I (n = 64) was 1.8%, with no cardiac-related deaths; the mortality rate in group II (n = 63) was 9.5% (8% cardiac-related deaths). No deaths occurred in group III (n = 19). The difference between the cardiac mortality rates in groups I and II was significant (p = 0.02) as was the postoperative cardiac morbidity: total myocardial infarctions (p less than 0.001); congestive heart failure (p = 0.02); tachyarrhythmias (p = 0.05).(ABSTRACT TRUNCATED AT 250 WORDS)     

The CardioWest total artificial heart as a bridge to transplantation

The CardioWest total artificial heart (TAH), formerly known as the Jarvik-7 and then the Symbion heart, is the only TAH in current clinical use. A new study, approved by the Food and Drug Administration (FDA), was initiated in 1993 with the goal of approving this pump for commercial release. Since then, 145 CardioWest TAHs have been implanted, including 37 pumps in 36 patients at our center. Our 36 patients were studied prospectively according to the investigational device exemption protocol approved by the FDA. Clinical and hemodynamic data obtained upon patients' entry into the study identified this group as mortally ill. After receiving a CardioWest TAH, 29 of the 36 patients (81%) survived to heart transplantation, and 26 (72% of the total group and 90% of the transplant recipients) have survived for up to 7 years (average, 24 months). Multicomponent anticoagulation, based on readily available tests, and the intrinsic properties of the TAH have resulted in a low linearized stroke rate of 0.48 event per patient-year. There have been no device-related mediastinal infections. In dying patients with nonexistent or severely compromised biventricular function, the CardioWest TAH has proved safe and effective, allowing a 72% survival rate for an average of 24 months.     

Clinical Indications for the Use of the "Poisk–IOM" Total Artificial Heart: The Experience of 13 Implantations in Humans

Success of total artificial heart (TAH) implantation as a temporary measure depends on three factors: proper patient selection, adequate surgical technique, and safe cardiac prostheses. From 1986 until March 1990, 237 patients with stagnant heart failure were examined. Sixty-one patients (27%) were put on a waiting list. Thirty-eight percent of them died awaiting transplantation. Thirteen TAH implantations were performed; nine patients who were not on a waiting list underwent TAH implantation by urgent indications. Four other patients underwent bridge TAH implantation after cardiac surgery. Our experience shows that the status of a patient before transplantation is a determinant factor and that it is possible to perform TAH implantation only in patients on a waiting list.     

Total artificial heart bridge to transplantation: a 9-year experience with 62 patients.

BACKGROUND: The SynCardia CardioWest total artificial heart (CardioWest TAH) is a biventricular, orthotopic, pneumatic, pulsatile blood pump driven by an external console. For each ventricle, the length of the blood-flow path is shorter and the inflow and outflow valves are larger than in any other bridge-to-transplant device, resulting in greater blood flow at smaller pre-load. Such a device should be optimal for bridging transplant candidates who have biventricular failure and for whom all other therapies have failed. METHODS: From January 1, 1993, to April 1, 2002, we prospectively studied 62 consecutive CardioWest TAH implant recipients to document safety and efficacy in bridge to transplantation. We used multisystem monitoring and multidrug therapy for anti-coagulation in 58 patients starting September 1, 1994. RESULTS: Before implantation, patients were critically ill with biventricular heart failure. Mortality in this group from the time of implantation until transplantation was 23%. Causes of death during device support included multi-organ failure (6), sepsis (3), and valve entrapment (2). Forty-eight patients underwent transplantation (77%). Forty-two survived to hospital discharge (68% of the total, 88% of those undergoing transplantation). Adverse events included bleeding (20%), device malfunction (5%), fit complications (3%), mediastinal infections (5%), visceral embolus (1.6%), and stroke during support (1.6%). The linearized stroke rate was 0.068 events per patient-year. CONCLUSIONS: Sixty-eight percent of critically ill transplant candidates for whom medical therapy failed were bridged to transplantation with the CardioWest TAH and survived long-term. Most deaths that occurred during device support were related to pre-implant problems. Infection and stroke were rare events. Therefore, we recommend the CardioWest TAH as the biventricular bridge-to-transplant device of choice.     

Response of right ventricular function to prostaglandin E1 infusion predicts outcome for severe chronic heart failure patients awaiting urgent transplantation.

BACKGROUND: Selection of patients for urgent heart transplantation who have end-stage heart failure requires objective criteria to distinguish between subjects who may deteriorate clinically and those who can be stabilized. This population appears to differ in terms of right ventricular function, and right ventricular changes in loading may provide prognostic information. To investigate predictive parameters of patients admitted for urgent heart transplantation, we prospectively studied the mechanical performance of the right ventricle during acute afterload reduction. PATIENTS AND METHODS: We studied 68 heart failure patients hospitalized for bridge-to-transplant. The patients underwent right heart catherization at baseline and during prostaglandin E1 infusion. We stratified patients according to clinical outcome: Group A comprised patients who could be weaned from bridging therapy or who were electively transplanted after at least 90 days, and Group B comprised patients who died or who remained unstable and required transplant under urgent conditions. RESULTS: Right ventricular hemodynamics at baseline were comparable in both groups. However, during maximal vasodilatation, with prostaglandin E1 infusion, the right ventricular end-diastolic volume index (EDVI) was significantly reduced in Group A, (-23 ml/m(2) (p < 0.01) vs +12 ml/m(2) (p = n.s. DeltaEDVI in Group B. Reduction of EDVI by less than 10% during prostaglandin E1 infusion has a sensitivity of 89% and a specificity of 70% for clinical deterioration. CONCLUSIONS: The response of right ventricular volumes to prostaglandin E1 may predict the outcome of patients with severe congestive heart failure listed for urgent heart transplantation.     

Experience with beta-blocker therapy in patients with advanced heart failure evaluated for HTx.

BACKGROUND: The aim of this study was to review our experience with beta-blocker therapy on top of high-dose angiotensin-converting enzyme inhibitors (ACE-I) in patients with advanced heart failure evaluated for heart transplantation, and to question the value of intended heart transplantation for patients receiving this therapy. METHODS: Three hundred eighteen patients (New York Heart Association (NYHA) function class III 34%, class IV 66%, average left ventricular ejection fraction (LVEF) 16%, and average cardiac index 2.2 l/min per m(2) at time of referral) were treated with digitalis, loop diuretics, maximally uptitrated ACE-I, beta-blockers (if tolerated), and intravenous support (if needed). After 3 months, patients were retrospectively stratified into those receiving beta-blockers plus ACE-I (Group A, n = 126), ACE-I (Group B, n = 135), and ACE-I plus intravenous support (Group C, n = 57). Endpoint 1 of the study was combined urgent heart transplantation, mechanical assist device implantation, and pretransplant death during a follow-up of 12 to 48 (mean 19 +/- 11) months. Endpoint 2 was posttransplant mortality up to 48 (mean 14 +/- 8) months. RESULTS: In the pretransplantation period the survival rate was 58% and the mortality rate was 20%. Between Groups A and B there was a significant difference in mortality (9% vs 27%, p = 0.001) due to a lower sudden-death rate in Group A (6% vs 17%, p < 0.01). While between Groups A and C all event rates of Endpoint 1 differed significantly, between Group C and Group B total mortality (30% vs 27%) was similar. However, in Group C urgent heart transplantation (HTx) was more often performed than in Group B (54% vs 11%, p < 0.0001). Seventy of 318 patients (22%) underwent heart transplantation (16% urgent, 6% elective). Posttransplant actuarial survival of the entire transplanted cohort (n = 70, 12 deaths) was significantly lower (log rank p < 0.01) than event-free survival in Group A (n = 126, 18 events), significantly higher (log rank p < 0. 0001) than event-free survival in Group C (n = 57, 34 events), and similar to that in Group B (n = 135, 52 events). CONCLUSION: This experience suggests that it may be particularly useful to add a beta-blocker to ACE-I therapy in patients referred for heart transplantation. In patients who tolerate this treatment, heart transplantation does not seem to provide additional survival benefit in the short term (2 years).     

Mechanical Support and Medical Therapy Reverse Heart Failure in Infants and Children

Most infants and children implanted with ventricular assist devices (VADs) go on to cardiac transplantation. Recovery of dilated cardiomyopathies with the combination left ventricular decompression with a VAD and treatment with maximal medical therapy has been possible in some adults, and may be more feasible in infants and children. We used pulsatile and continuous flow VADs and the total artificial heart (TAH) as bridges to transplantation or to recovery. Candidates for native heart recovery were treated with maximal medical therapy for congestive heart failure and short‐term dobutamine prior to weaning off device support. Since 1997, 28 infants and children, ages 1 month to 16 years, were implanted for durations of 3–107 days (mean 27). Eighteen received left VADs (LVAD), seven biventricular assist devices (BiVADs), and three TAHs. Device‐related mortality was 7/28 (25%), leaving 21/28 (75%) surviving to transplantation or weaning from device support and 20/28 (71%) discharged from the hospital and currently surviving for 2 months to 9 years. Ten of 11 transplant recipients (90%) have survived 2 to 9 years. All 10 with recovered hearts are alive and well for 2 months to 5 years. Eight of 12 (67%) LVAD patients with dilated hearts recovered. None of the recovery patients were over 6 years old. Infants and children who have failed inotropic therapy may be treated with an LVAD and medical therapy for congestive heart failure anticipating native heart recovery. A variety of devices have been tried. All small LVADs yielded comparable results. Larger and older children also have a chance of recovery, but our experience with them is too small except to note that they do well with larger devices and transplantation.     

Selected patients listed for cardiac transplantation may benefit from defibrillator implantation regardless of an established indication.

BACKGROUND: End-stage heart failure (HF) patients are at high risk of sudden cardiac death. This study evaluates the role of implantable cardiac defibrillators (ICDs) in HF patients awaiting cardiac transplantation. METHODS: We identified 194 consecutive patients (age 51 +/- 12 years) with New York Heart Association Class 3 or 4 HF (ejection fraction 22 +/- 9%) listed for cardiac transplantation, 35 of whom underwent ICD implantation. Of the implanted patients, 16 (Group A) had an established indication for ICD implantation (cardiac arrest, n = 10; sustained ventricular tachycardia [VT], n = 3; and positive electrophysiology study, n = 3). Nineteen patients (Group B) underwent ICD implantation for non-established indications (syncope with non-ischemic cardiomyopathy, n = 4; non-sustained VT, n = 15). There were no procedural complications from ICD implantation. RESULTS: During follow-up of 9.2 +/- 10.1 months, there were 3 deaths in the ICD groups (A and B), and 40 in the control group (8.6% vs 25.2%, p = 0.032). Five patients in Group A and 6 in Group B (31%) received appropriate ICD therapy. The number of therapies per patient and the time to the first shock were similar between Groups A and B. Four of 6 Group B patients on outpatient inotropic therapy (67%) received appropriate ICD therapy. CONCLUSIONS: Selected end-stage heart failure patients awaiting heart transplantation, including those without established ICD indications, are at high risk for malignant arrhythmias and may benefit from ICD implantation. Patients with ICD seem to have improved survival compared to those without ICD. Randomized prospective studies are needed to confirm these findings.     

Decreased recipient survival following orthotopic heart transplantation with use of hearts from donors with projectile brain injury.

BACKGROUND: Fatal gunshot injury to the brain can cause significant alterations in the neuroendocrine state and myocardial dysfunction. Therefore heart allografts from these donors may result in graft failure following orthotopic heart transplantation (OHTx). We evaluated whether receiving a heart from a donor who died from fatal gunshot wound to the brain independently affected the outcome of transplantation. METHODS: A retrospective review of 113 consecutive patients undergoing OHTx at a university hospital from 1996 to 2002 was performed. Group 1 received hearts from donors with fatal gun shot brain injury (n = 17), and Group 2 received hearts from donors who died from other causes (n = 96). RESULTS: Recipient age, gender, United Network for Organ Sharing (UNOS) status, indication for transplantation, and other co-morbid conditions were similar in both groups. Young male donors pre-dominated in Group 1, but other donor characteristics were not significantly different. The incidence of Grade 3A rejection was higher in Group 1 than Group 2 (35% vs 6.3%, p = 0.003), as was the incidence of post-operative infection (35% vs 7.2%, p = 0.004). Actuarial survival at 1 and 5 years was significantly lower in Group 1 than in Group 2 (81% and 74% vs 97% and 94%, respectively, p = 0.005). Multivariate logistic regression analysis also demonstrated that fatal gunshot brain injury, as cause of donor death, was a risk factor for recipient mortality (p = 0.01). CONCLUSION: Receiving a heart from a donor with fatal gunshot brain injury is a significant risk factor for recipient mortality following OHTx. Cautious use of heart allograft from these donors, especially in low-risk recipients, may lead to improved outcome following heart transplantation.     

Outcome of children with end-stage congenital heart disease waiting for cardiac transplantation.

BACKGROUND: End-stage congenital heart disease (CHD) is a major indication for pediatric cardiac transplantation. The objective of the study was to evaluate pre-transplant outcome of children with CHD. METHODS: The clinical profile and outcome of patients with CHD <20 years of age listed for transplantation (1993 to 1999) were reviewed and patients who died waiting (Group I) were compared with survivors to transplant (Group II). RESULTS: Mean age of the patients (n = 46) was 8.3 +/- 8 years. Primary indications for transplant were ventricular dysfunction in 36 (78%), failed Fontan in 8 (18%) and severe hypoxemia in 2 (4%) patients. Thirty-two patients were Status 1 (70%), 14 were Status 2 and 5 patients were de-listed. Twenty-nine of the 41 patients that remained listed survived to transplant, 12 (29%) died waiting. Causes of death were sepsis in 2 and severe heart failure (HF) in 10 patients. Eight patients died with multi-system organ failure, including 3 on mechanical circulatory support. Mean time to death was 29 +/- 28 days and time to transplant was 94 +/- 176 days. Mean age at listing was younger in Group I (2.6 +/- 4 years) compared with Group II (9.1 +/- 7 years, p < 0.05). Mean HF duration was shorter in Group I (3.6 +/- 3.9 months) compared with Group II (25 +/- 33 months, p < 0.05). Fifty-day actuarial survival on the waiting list was lower in infants (38%) compared with older children (91%, p < 0.05). In contrast to the high mortality (71%) in infants with CHD, all infants with cardiomyopathy survived to transplant. CONCLUSIONS: Seventy-one percent of patients listed with CHD survived to transplant. Younger age at listing and rapid onset of HF were significant risk factors for pre-transplant mortality.     

Preoperative risk analysis in patients receiving Jarvik-7 artificial heart as a bridge to transplantation.

To distinguish high-risk patients prior to implantation of a Jarvik-7 artificial heart as a bridge to transplantation, our 37 attempts were reviewed retrospectively. Arbitrary scores of 1 to 4 were given for nine preoperative factors on the basis of results obtained by uni- and multivariate analyses between successful cases and failed attempts; transplant rejection (scored 4: S4) or postoperative heart failure (S3) as the indication, recipient height less than 175 cm (S3), body surface area less than 1.8 m2 (S3), hyperbilirubinemia greater than 24 microM/l (S2), preoperative renal failure requiring dialysis (S2), weight less than 60 kg (S2), and age greater than 40 years (S1). All except one of the 16 patients with successful bridge had a total score of less than 4, with an average score of 1.3 in contrast to 6.6 in the 21 failed cases (p less than 0.001). Among the 17 patients who scored less than 4, 15 received transplants (specificity 90%), while only one qualified for transplantation among 20 patients who scored 4 or more (sensitivity 94%). The two unpredicted failures resulted from mediastinitis and pulmonary infarction, both attributable to postoperative management. Multiple preoperative factors in combination could have successfully predicted the outcome of mechanical support in our experience. These results underscore the importance of patient selection to achieve successful and effective use of the Jarvik-7 as a bridge to heart transplantation.     

Mechanical circulatory support as a bridge to transplantation: current status of total artificial heart in 1989 and determinants of survival

Since April 1986, 40 total artificial hearts (TAH) were implanted as a bridge to transplantation in our institution. In an attempt to identify factors affecting survival of TAH recipients we reviewed our experience over 1000 days of mechanical support. There was no postoperative bleeding requiring surgery nor were there any clinical episodes of thromboembolic complications. Over a total functioning period greater than 3 years there were no mechanical failures in the driving system but one artificial ventricle had to be replaced because of mechanical dysfunction. Infections and multiple organ failure were the primary causes of morbidity and mortality during mechanical support. When the patients who underwent staged transplantation (no. 17) were compared with those who died during mechanical support (no. 23) there were no differences in TAH driving mode or hemodynamic variables between the groups. Although preoperative pulmonary, hepatic and renal functions were found to be similar between the groups, there were significant differences in the early evolution (3 days) of hepatic and renal functions following TAH implant (p less than 0.01). Urinary output was found to be the earliest variable discriminating recovery and survival (p less than 0.01). Finally, univariate analysis indicated age (less than 40 vs greater than 40 years) and modality of cardiac decompensation (acute vs chronic) as the most important factors affecting survival after TAH implantation. Since young patients (less than 40 years of age) with acute decompensation were successfully transplanted in 82% of cases while 100% of older patients with chronic decompensation died before or after transplantation, TAH should be advised in young patients with acute or chronic heart failure and in selected older candidates with recent, acute cardiac failure.     

Heart transplantation in insulin–treated diabetic patients with diabetes–related complications

Heart transplantation is the most effective therapy for end-stage heart failure in patients with diabetes mellitus (DM). However, diabetes-related complications (DRCs) are a relative contraindication for heart transplantation. Nevertheless, the increasing prevalence of both DM and congestive heart failure makes it necessary to perform heart transplantation even in those patients with advanced DM. We performed a retrospective analysis on long-term survival in 47 patients with insulin-treated DM and DRCs (group 1). Survival rate and causes of death were compared with data of a group of heart transplant recipients without DM (n = 1061, group 2). Mean follow-up time of all heart transplant recipients was 68.2 months (range: 0-204 months). Overall mortality during follow-up was 42.9%. Long-term survival did not differ significantly between study groups, but tended to be shorter in group 1 than in group 2 (P = 0.07). In group 1, steroid-free immunosuppressive therapy was associated with a higher percentage of long-term survivors compared with no steroid-free immunosuppression. Our data demonstrate that long-term survival is acceptable in heart transplant recipients with preoperatively diagnosed DM and DRCs. Consequently, advanced DM should no longer be a relative contraindication for heart transplantation.     

Bridge to heart transplantation with the HeartMate device in Gothenburg, Sweden

BACKGROUND: Patients rapidly deteriorating while waiting for heart transplantation present a major problem. Our strategy for this entity is the HeartMate left ventricular assist device (LVAD) VELVAS, an electrically driven implantable LVAD. Herein we report our initial experience. METHODS: The medical records of all the patients who received HeartMate LVAS at our institution were reviewed. RESULTS: From January 1997 through May 2004, 19 patients received a HeartMate. The mean age was 39 (15 to 61) years and 84% were men. The diagnoses were: dilated cardiomyopathy (n = 8), ischemic heart disease (n = 6), myocarditis (n = 3), congenital heart disease (n = 1), and hypertrophic cardiomyopathy (n = 1). Mean time on LVAD was 113 (10 to 353) days. Ten patients were discharged from the hospital to their homes awaiting transplant or recovery. Three patients showed recovery of heart function and were subsequently weaned from mechanical support. Thirteen patients underwent heart transplantation. Three patients died during LVAD treatment. Major adverse events occurred in nine patients, including severe right heart failure (n = 3), severe bleeding (n = 3), stroke (n = 1), hepatic failure (n = 1), and septicemia (n = 2). Nine of the 13 transplanted patients are alive and well today. CONCLUSION: HeartMate LVAS is a valuable option for patients rapidly deteriorating while awaiting a heart transplant. Our results are comparable with those reported from larger centers.     

Use of hearts transplanted from donors with atraumatic intracranial bleeds.

BACKGROUND: Donor atraumatic intracranial bleed (aICB) is associated with older age and may reflect a history of hypertension. Hearts from donors who died of aICB may be at increased risk for graft failure because of the associated catecholamine surge. We evaluated whether receiving a heart from a donor who had an aICB independently affected the outcome of transplantation. METHODS: We reviewed adult patients (>18 years) who underwent heart transplantation between July 1994 and December 1999. We excluded patients who received non-standard hearts (e.g., donor age >55 years). Group 1 received hearts from donors with aICB (n = 80), and Group 2 received hearts from donors who did not have aICB (n = 171). RESULTS: Recipient age, gender, United Network for Organ Sharing status, and indication for transplantation were similar for both groups. Donors in Group 1 were older (41 vs 26 years, p = 0.001), more commonly women (55% vs 20%, p = 0.001), and more often had history of hypertension (26% vs 2%, p = 0.001). Survival to discharge was 86% in Group 1 and 95% in Group 2. Actuarial 5-year survival was 72% for Group 1 and 81% for Group 2 (p = 0.52). Regression analysis showed that receiving a heart from a donor with aICB was a risk factor for early recipient mortality but not for long-term outcome (odds ratio = 3.25, p = 0.02, and hazard ratio = 1.16, p = 0.69, respectively). Donor aICB, female gender, and abnormal initial echocardiogram (global hypokinesia) were selected as clinically relevant independent risk factors for early mortality of the recipient, using a fitted multifactor logistic regression model (goodness-of-fit chi-square p value = 0.94). Donor age, accident-to-retrieval time interval, and borderline left ventricular hypertrophy did not significantly differ. Five-year freedom from transplant coronary artery disease in Group 1 was 74% (vs 80% in Group 2, p = 0.05). CONCLUSIONS: The trend observed in this series suggests that receiving a heart from a donor with aICB is a potential independent risk factor for early mortality after transplantation independent of age. Caution should be used when evaluating such donors, particularly when other risk factors such as female donor or depressed ejection fraction are present.     

Long-term survival after cardiac retransplantation: a twenty-year single-center experience

OBJECTIVE: To identify risk factors for survival after cardiac retransplantation and compare the survival after retransplantation with that after primary cardiac transplantation. METHODS: A retrospective analysis of 952 patients undergoing cardiac transplantation for the treatment of end-stage heart disease at a single center between 1977 and October 1997. Of these, 43 patients (4.5%) underwent cardiac retransplantation for cardiac failure resulting from transplant-related coronary artery disease, rejection, and early graft failure. RESULTS: No significant difference in actuarial patient survival was found by Kaplan-Meier analysis at 1, 2, and 5 years between patients undergoing primary transplantation and those undergoing retransplantation 76%, 71%, and 60% versus 66%, 66%, and 51%, respectively (P =.2). Multivariable analysis identified a shorter interval between transplants and an initial diagnosis of ischemic cardiomyopathy as significant risk factors for death after retransplantation (P =.04 and.03, respectively). Since 1993, when our criteria for patient selection for retransplantation were revised on the basis of earlier experience to exclude patients with allograft dysfunction as a result of primary graft failure and those with intractable acute rejection occurring less than 6 months after transplantation, the survival has been significantly better (<1993 = 45%, 45%, and 33% versus >/=1993 = 94%, 94%, and 94% at 1, 2, and 4 years, respectively, P =.003). CONCLUSION: The long-term outcome of cardiac retransplantation is comparable with that of primary transplantation, especially in patients with transplant-related coronary artery disease. Patient characteristics and other preoperative variables should assist in the rational application of retransplantation to ensure optimal use of donor organs.     

Simultaneous heart and kidney transplantation for combined cardiac and renal failure

Simultaneous heart and kidney transplantation (SHKT) is feasible for combined cardiac and renal failure. Herein we reviewed our 10-year experience in SHKT. Six patients underwent SHKT from June 1995 to December 2004. Their ages ranged from 13 to 63 years old with a mean of 45.5 +/- 15.8 years. They were all men except one girl, who was the youngest (aged 13) who suffered from dilated cardiomyopathy with congestive heart failure and chronic renal failure due to systemic lupus erythematosus. Because of aggravating heart failure, she changed from hemodialysis to peritoneal dialysis. Because of intractable heart failure, she underwent SHKT from a 24-year-old female donor. All received hemodialysis before SHKT. The indications for heart transplantation included dilated cardiomyopathy (n = 3), ischemic cardiomyopathy (n = 1), cardiac allograft vasculopathy (n = 1), and cardiac allograft failure (n = 1). The immunosuppressive protocol and rejection surveillance were these employed for heart transplantation. No operative mortality was noted in this study. The 1-year and 5-year survival rates were the same, 83%. The 10-year survival rate was 55%. No cardiac or renal allograft rejection was noted. No renal allograft loss was noted. There were two late mortalities: the one, who underwent redo heart transplantation for coronary artery vasculopathy died of cardiac allograft failure 1 year after SHKT. The other patient died of massive ischemic necrosis of the intestine at 6 years after SHKT. Our experience showed that SHKT had good short- and long-term results without increasing immunosuppressive doses. End-stage failure of either the heart or the kidney did not preclude heart plus kidney transplantation.     

Outpatients on mechanical circulatory support

BACKGROUND: As waiting periods for heart transplantation have lengthened, the application of long-term mechanical circulatory support (MCS) has become more common in patients presenting with cardiogenic shock. Anticipating increased long-term MCS, a policy to discharge patients home has been instituted. This study compares the results of outpatient on MCS to a group of patients remaining hospitalized. METHODS: We report our 10-year experience with 108 patients on MCS, who were supported for more than 3 months. Group A consisted of 38 patients (25 Novacor, 13 Berlin Heart) who underwent assist implantation from 1996 to 2001. They had a mean support time of 454 days (range 100 to 1074 days) and spent a mean of 326 days (range 20 to 769 days) at home. Group B consisted of 70 patients (24 Novacor, 46 Berlin Heart) who underwent assist implantation between 1991 and 2000. They had a mean support time of 234 days (range 95 to 795 days) and were not discharged. The patients were monitored for complications, hospital readmissions, and causes of death including infections and thromboembolic and bleeding events during the MCS time. RESULTS: Group A total mortality was 16% (6/38). Two patients died from cerebral embolism, one from cerebral hemorrhage, two from systemic infection, and one from multiorgan failure. Thirty-two patients (84%) required 95 readmissions to the hospital due to cerebral embolism (n = 9), bleeding (n = 1), wound infections (n = 23), coagulation disorder (n = 13) for heart transplantation (n = 5), and (n = 44). In group B the mortality was 43% (30/70) for noncardiac reasons and thus significant higher (p = 0.004, chi2 test). Causes of death were cerebral embolism (n = 5), cerebral hemorrhage (n = 7), systemic infection (n = 14, significantly higher, p = 0.04, chi2 test), and multiorgan failure (n = 4). CONCLUSIONS: Our experience demonstrates that MCS can be used in outpatients without increased mortality and with an acceptable rate of readmissions (2.8/patient). It ensures the survival of the patient, enables recovery from multiorgan failure, and offers an acceptable quality of life.