Long term follow-up of the tacrolimus in combination, tacrolimus alone compared (TICTAC) trial.

BACKGROUND: Tacrolimus (TAC) monotherapy has been compared to TAC and mycophenolate mofetil (MMF) in the randomized Tacrolimus in Combination, Tacrolimus Alone Compared (TICTAC) trial. Long term results are now reported. METHODS: Demographics are presented with descriptive statistics. Time to event was determined with Kaplan-Meier plots and Mantel-Cox Logrank statistics used to compare groups. RESULTS: One hundred and forty-seven (98 %) of the initial 150 TICTAC trial patients had long-term follow-up data available. The median follow-up was 13.4 years (interquartile range 7.2-15.1 years). Post-transplant survival at 5, 10 and 15 years in the TAC monotherapy group was 84.5 %, 66.9 %, and 52.7 %, and 94.4 %, 78.2 % and 56.1 % for patients randomized to TAC / MMF (p = 0.19 logrank). The freedom from cardiac allograft vasculopathy (≥grade 1) was 100 %, 87.5 %, 69.3 % and 46.5 % at 1, 5, 10 and 15 years in the monotherapy group and 100 %, 76.9 %, 68.1 % and 54.4 % in the TAC/MMF group respectively (p = 0.96 logrank). Crossover of treatment assignment did not alter these findings. The freedom from dialysis or renal replacement was 92.8 %, 84.2 % and 68.4 % for TAC monotherapy patients versus 100 %, 93.4 % and 82.3 % for TAC/MMF patients at 5, 10 and 15-years post-transplant (p = 0.15 logrank). CONCLUSIONS: Patients randomized to TAC/ MMF with 8-week steroid weaning had comparable outcomes to those with similar steroid regimen but discontinuation of MMF at 2 week post-transplant. The best outcomes were noted for patients initiated on TAC/ MMF including those where MMF was discontinued for intolerance. Both strategies are reasonable alternatives for patients post heart transplant. CONDENSED ABSTRACT: Tacrolimus monotherapy was compared to TAC and mycophenolate mofetil without long term steroids in the randomized Tacrolimus in Combination, Tacrolimus Alone Compared (TICTAC) trial. Post-transplant survival at 5, 10 and 15 years in the TAC monotherapy group was 84.5%, 66.9 %, and 52.7 %, and 94.4 %, 78.2 % and 56.1 % for patients randomized to TAC / MMF (p = 0.19 logrank). Cardiac allograft vasculopathy and kidney failure were similar between groups. Immunosuppression should be individualized to avoid over treating some patients while undertreating others.

Derivation and validation of the bridge to transplantation with left ventricular assist device score for 1 year mortality after heart transplantation. The BTT-LVAD score.

BACKGROUND: To derive and validate a risk score that accurately predicts 1-year mortality after heart transplantation (HT) in patients bridged to transplant (BTT) with a left ventricular assist device (LVAD). METHODS: The UNOS database was queried to identify patients BTT with an LVAD between 2008 and 2018. Patients with ⩾1-year follow up were randomly divided into derivation (70%) and validation (30%) cohorts. The primary endpoint was 1-year mortality. A simple additive risk score was developed based on the odds of 1-year mortality after HT. Risk groups were created, and survival was estimated and compared. RESULTS: A total of 7759 patients were randomly assigned to derivation (n = 5431) and validation (n = 2328) cohorts. One-year post-transplant mortality was 9.8% (n = 760). A 33-point scoring was created from six recipient variables and two donor variables. Risk groups were classified as low (0-5), intermediate (6-10), and high (>10). In the validation cohort, the predicted 1-year mortality was significantly higher in the high-risk group than the intermediate and low-risk groups, 14.7% versus 9% versus 6.1% respectively (log-rank test: p < 0.0001). CONCLUSION: The BTT-LVAD Score can serve as a clinical decision tool to guide therapeutic decisions in advanced heart failure patients.

Outcomes of Obese Patients Bridged to Heart Transplantation with a Left Ventricular Assist Device.

The current study aims to investigate the impact of left ventricular assist device (LVAD) implantation on weight loss and functional status in obese patients bridged to transplantation (BTT). The United Network for Organ Sharing (UNOS) database was queried to identify patients with body mass index (BMI) ≥ 30 who underwent LVAD implantation as BTT from 2008 to 2018. Patients were divided into three groups based the World Health Organization classification of obesity: obesity class I (BMI, 30.0-34.9 kg/m2), obesity class II (BMI, 35-39.9 kg/m2), and obesity class III (BMI, >40 kg/m2). Patients with incomplete data on BMI were excluded. The primary outcome was a change in BMI while listed. Secondary outcomes included a change in functional status after LVAD implantation and posttransplant morbidity and survival. Out of 14,191 patients who had an LVAD while listed within the study period, 5,354 (37.7%) had a BMI ≥30 kg/m2. Obesity was classified as class I in 3,909 (73%), class II in 1,275 (23.8%), and class III in 170 (3.2%) patients. Among patients with complete data on BMI, 18.9% (n = 394) reported a change in BMI, leading to an improvement in their obesity class, and this was similar for all obesity classes (22% [n = 331], 50% [n = 111], and 60% [n = 43] for classes I, II, and III, respectively). All groups reported an improvement in functional status (65% vs. 62% and 61% for classes I, II, and III, respectively). Posttransplant survival was not significantly different between obese groups (p = 0.787). Compared with classes I and II, the incidence of thrombosis (p = 0.0006) and device malfunction (p = 0.036) was significantly higher in the class III group. About one out of every five obese patients listed for heart transplantation with an LVAD loses weight, leading to a change in their BMI class. Most patients reported a significant improvement in their functional status. Among those successfully BTT, posttransplant survival was similar.

Racial disparities and outcomes of left ventricular assist device implantation as a bridge to heart transplantation.

AIMS: This study investigated outcomes after continuous flow left ventricular assist device (CF-LVAD) implantation as bridge to heart transplantation (BTT) in advanced heart failure patients stratified by race. METHODS AND RESULTS: De-identified data from the United Network for Organ Sharing database was obtained for all patients who had a CF-LVAD as BTT from 2008 to 2018. Patients were stratified into four groups on the basis of ethnicity [Caucasian, African American (AA), Hispanic, and others (Asian, Pacific Islanders, and American Indian)]. Outcomes investigated were waitlist mortality or delisting and post-transplant 5 year survival. Cox proportional hazards modelling was used to identify independent predictors of waitlist mortality or delisting and post-transplant survival. We used Kaplan-Meier survival curves and the log-rank test to estimate and compare survival among groups. A total of 14 234 patients who had CF-LVADs as BTT were identified. Of these, 64% (n = 9058) were Caucasians, 26% (n = 3677) were AA, 7% (n = 997) were Hispanic, and 3% (n = 502) had a different race. Compared with Caucasian, AA, and Hispanic patients had higher body mass indexes and a lower level of education and are more likely to be public health insurance beneficiaries. There was a significantly lower incidence of transplantation in AAs compared with Caucasians, Hispanics, and others at 12, 24, and 60 months, respectively (Gray's test, P < 0.001). The AA race was a significant predictor of waitlist mortality or delisting owing to worsening clinical status [hazard ratio, 95% confidence interval: 1.10 (1.01 to 1.16; P < 0.001)]. Among those who were successfully BTT, risk-adjusted post-transplant survival was similar among the four groups (log-rank test: P = 0.589). CONCLUSIONS: Disparities exist among different races that receive a CF-LVAD as a BTT. These disparities translate into increased waitlist morbidity and mortality but not long-term post-transplant survival among those who successfully reach transplant.

Association between increased-risk donor social behaviors and recipient outcomes after heart transplantation.

BACKGROUND: This study aims to investigate the association between social behaviors of increased-risk donors (IRD) and recipient outcomes after heart transplantation. METHODS: The United Network for Organ Sharing (UNOS) database was queried to identify patients who received a heart transplant between 2004 and 2015. Patients were grouped based on donor's risk status (IRD vs standard risk donor [SRD]). Recipients of IRD were categorized based on donor social behaviors (SB), and recipient survival was assessed. Cox regression analysis was used to identify associations between SB of donors and recipient survival. RESULTS: Out of 22 333 heart transplantations performed during the study period, 2769 (12%) received an IRD graft with the following SB: Unprofessional tattoos or piercings (n = 1722) (63%), cocaine use (n = 916) (33%), heavy smoking (n = 437) (16%), and heavy alcohol abuse (n = 610) (22%). Viral screens detected 72(3%) hepatitis B virus (HBV) positive and 12 (0.4%) hepatitis C virus (HCV) positive at donation. There was no difference in recipient survival based on both donor risk and their social behaviors. Cox regression analysis found only donor HCV infection and non-identical ABO mismatch to be associated with poor recipient survival among recipients of IR grafts. CONCLUSION: Cardiac allografts from IRD, serologically negative for viruses, can safely be used. There is no association between social behaviors of IRD and recipient survival.

Racial Disparities and Outcomes After Left Ventricular Assist Device Implantation as Bridge to Transplantation or Destination Therapy.

OBJECTIVE: We sought to investigate outcomes after left ventricular assist device (LVAD) implantation in advanced heart failure patients stratified by race. METHODS: Patients who had LVADs inserted at a single center as a bridge to transplant (BTT) or destination therapy (DT) were divided into 3 groups based on race: Caucasian, African American (AA), and Hispanic. Postoperative outcomes including complications, discharge disposition, and survival at defined time points were compared. Cox proportional hazards were used to identify factors associated with 1-year all-cause survival. RESULTS: A total of 158 patients who had LVADs as BTT (n = 63) and DT (n = 95) were studied. Of these, 56% (n = 89) were Caucasians, 35% (n = 55) were AA, and 9% (n = 14) were Hispanics. AA patients had higher BMI and lower socioeconomic status and educational level, and were more likely to be single or divorced. Operative outcomes were similar among all 3 groups. Unadjusted 30-day, 6-month, 1-year, and 2-year survival rates for Caucasians versus AA versus Hispanics were 82% versus 89% versus 93%, P = 0.339; 74% versus 80% versus 71%, P = 0.596; 67% versus 76% versus 71%, P = 0.511; and 56% versus 62% versus 68%, P = 0.797. On multivariate analysis, device-related infection, malfunction, and abnormal rhythm were factors associated with overall all-cause mortality. CONCLUSION: AA patients who undergo LVAD implantation as BTT or DT have lower socioeconomic status and educational level compared to their Caucasian or Hispanic counterparts. These differences, however, do not translate into postimplant survival outcomes.

Bibliometric Analysis of the Top 100 Most Cited Articles in the First 50 Years of Heart Transplantation.

The world celebrates over 50 years since the first human-to-human heart transplant. Bibliometric analysis is a statistical concept that has recently evolved, enabling scientists to study citation patterns and identify characteristics of highly cited scholarly work in different fields. Although it has been widely utilized, such analyses have not been conducted to date on heart transplant literature. We sought to assess the characteristics of the top 100 most referenced citations in the field of heart transplantation. We searched the Scopus database (www.scopus.com) to identify all articles relating to heart transplantation. The articles were arranged in descending order from most cited to least cited and selected articles were scrutinized for data extraction. One hundred articles were included in the final list. Of the total 40,660 citations identified, 3,210 (8.0%) were self-citations, which impacted the final rank order. The articles were published in 25 different journals between 1960 and 2013. The most productive 5-year time period was between 2000 and 2005, when 24 of the 100 most cited publications were produced. There was no correlation between the journals' impact factors and the number of articles produced per journal. The presence and type of funding were not associated with the number of citations. Over 85% of first and senior investigators were men. In conclusion, our study highlights key features of the most highly cited scientific literature on heart transplantation and provides insights into trends of published work in this field. Additionally, this work may serve as a useful guide to researchers and funding bodies by highlighting the most prolific areas of cardiac transplant research to date.

Ex-vivo perfusion of donor hearts for human heart transplantation (PROCEED II): a prospective, open-label, multicentre, randomised non-inferiority trial.

BACKGROUND: The Organ Care System is the only clinical platform for ex-vivo perfusion of human donor hearts. The system preserves the donor heart in a warm beating state during transport from the donor hospital to the recipient hospital. We aimed to assess the clinical outcomes of the Organ Care System compared with standard cold storage of human donor hearts for transplantation. METHODS: We did this prospective, open-label, multicentre, randomised non-inferiority trial at ten heart-transplant centres in the USA and Europe. Eligible heart-transplant candidates (aged >18 years) were randomly assigned (1:1) to receive donor hearts preserved with either the Organ Care System or standard cold storage. Participants, investigators, and medical staff were not masked to group assignment. The primary endpoint was 30 day patient and graft survival, with a 10% non-inferiority margin. We did analyses in the intention-to-treat, as-treated, and per-protocol populations. This trial is registered with ClinicalTrials.gov, number NCT00855712. FINDINGS: Between June 29, 2010, and Sept 16, 2013, we randomly assigned 130 patients to the Organ Care System group (n=67) or the standard cold storage group (n=63). 30 day patient and graft survival rates were 94% (n=63) in the Organ Care System group and 97% (n=61) in the standard cold storage group (difference 2·8%, one-sided 95% upper confidence bound 8·8; p=0·45). Eight (13%) patients in the Organ Care System group and nine (14%) patients in the standard cold storage group had cardiac-related serious adverse events. INTERPRETATION: Heart transplantation using donor hearts adequately preserved with the Organ Care System or with standard cold storage yield similar short-term clinical outcomes. The metabolic assessment capability of the Organ Care System needs further study. FUNDING: TransMedics.

Lessons learned from the first fully magnetically levitated centrifugal LVAD trial in the United States: the DuraHeart trial.

BACKGROUND: The DuraHeart is a continuous centrifugal-flow left ventricular assist device that uses active magnetic levitation for impeller positioning designed for improved hemocompatibility and durability. This study reviews the results of the US trial with specific attention to hemolysis, thrombotic complications, and pump failure. METHODS: The US SUSTAIN trial was a multicenter, prospective, single-arm observational study in advanced heart failure patients listed for transplantation. Follow-up was complete in 100% of the patients at 6 months. RESULTS: Sixty-three patients were enrolled at 23 centers. Forty-six patients (73%) reached the primary end points of survival to transplantation, alive on the original device at 180 days and listed for transplantation, or explant for recovery. Median duration of support was 267 days (range, 10 to 952 days) with a total support time of 46 patient-years. There was no clinical hemolysis reported during the study. Mean lactate dehydrogenase values peaked at day 4 and significantly decreased during support (435±236 U/L and 297±142 U/L on day 3 and day 180, respectively). There were no cases of pump thrombosis reported, and 3 cases of pump thrombus "in transit" (0.06 events/patient-year) were observed. There were 6 (10%) cases of magnetic levitation system failure, all secondary to cable wire fractures (0.12 events/patient-year). All patients were hemodynamically stable with the backup hydrodynamic mode. Major adverse events included gastrointestinal bleeding (0.52 events/patient-year), ischemic and hemorrhagic strokes (0.17 events/patient-year and 0.09 events/patient-year, respectively), and driveline infections (0.67 events/patient-year). CONCLUSIONS: The DuraHeart demonstrated good hemocompatibility; however, the reliability of full magnetic levitation systems should be a high priority in future pump designs.

Successful Management of Thrombosis of the Proximal Aorta after Implantation with a Biventricular Assist Device.

Continuous-flow ventricular assist devices (CVADs) are associated with a significant complication profile that includes thrombosis of the ascending aorta and aortic valve, thromboembolism, and stroke. Despite an increasing number of reports of thromboembolic complications related to CVADs, there is little in the literature to guide their management. This report describes successful management strategies used during two cases of thrombosis of the ascending aorta during biventricular CentriMag (Levitronix LLC, Waltham, MA) support, including using pre-existing cannulas to initiate cardiopulmonary bypass.

A prospective, randomized trial of single-drug versus dual-drug immunosuppression in heart transplantation: the tacrolimus in combination, tacrolimus alone compared (TICTAC) trial.

BACKGROUND: Cardiac transplantation, a procedure nearly abandoned in the 1970s, has evolved into the standard of care for appropriate patients with end-stage heart failure. Much of this success has been due to improvements in immunosuppression, including the introduction of a triple-drug regimen. Retrospective reports suggested that single-drug immunosuppression with tacrolimus was feasible. As such, a prospective, randomized trial was conducted to test this approach. METHODS AND RESULTS: One hundred fifty adult de novo heart transplant recipients were enrolled in a prospective, randomized, controlled, open-label trial comparing tacrolimus monotherapy (MONO) with tacrolimus and mycophenolate mofetil therapy (COMBO). Corticosteroids were used in the early postoperative period but discontinued in all patients over 8 to 9 weeks. The primary end point was the composite biopsy score at 6 months after transplant. Patients were followed for 1 to 5 years. The composite biopsy score was similar between groups at 6 and 12 months: 6-month MONO, 0.70 ± 0.44 (95% confidence interval, 0.60 to 0.80) versus COMBO, 0.65 ± 0.40 (95% confidence interval, 0.55 to 0.74; P=0.44). Allograft vasculopathy was assessed by angiography and intravascular ultrasound, with no significant differences noted. Three-year survival was also similar (92.4% MONO versus 97% COMBO; P=0.58, log-rank). CONCLUSIONS: Addition of mycophenolate to single-agent immunosuppression did not provide an advantage over single-agent immunosuppression in terms of rejection, allograft vasculopathy, or 3-year survival. Corticosteroids, which have traditionally been a mainstay of therapy, were successfully discontinued in all patients. These conclusions are tempered by the limited statistical power associated with a sample size of only 150 patients. Clinical Trial Registration- URL: http://www.clinicaltrials.gov. Unique identifier: NCT00299221.

Abiomed biventricular assist device as a bridge to transplantation in a 14-year-old with cardiomyopathy resulting from ventricular noncompaction.

Ventricular noncompaction is a rare but well-documented cause of cardiomyopathy. This report presents a case of ventricular noncompaction diagnosed late in end-stage cardiac failure and malignant ventricular arrhythmia, which required an Abiomed biventricular assist device as a bridge to transplantation.

Infection after implantation of pulsatile mechanical circulatory support devices.

OBJECTIVE: INTERMACS is a registry of mechanical circulatory support devices sponsored by the National Institutes of Health. This analysis uses INTERMACS data to define the time course, incidence, and outcome of infection adverse events focusing on the first 3 months after implant. METHODS: Patients entered into INTERMACS from June 23, 2006, to September 30, 2008, were analyzed. Preimplant data (demographics, hemodynamics, and laboratory values), infection adverse events, and other outcomes were recorded. Infection adverse events were analyzed to compare infection rates in subgroups of patients and define risk factors for death. RESULTS: The analysis was confined to pulsatile mechanical circulatory support devices. A total of 593 patients from 88 institutions were entered. Infection was a relatively common event within the first 3 months of implant and was significantly (P = .005) more common in patients with biventricular assist devices than in patients with left ventricular assist devices, although the prevalence of infection equalized in months 4 to 12. Infection had a significant adverse effect on survival. Independent risk factors for death included support with a biventricular assist device, older age, severity of patient illness implantation of the device (INTERMACS level 1), and higher blood urea nitrogen. CONCLUSIONS: Infection remains a relatively frequent adverse event and is associated with decreased survival. Interventions to prevent infection that focus on the preoperative and immediate postoperative periods are the ones most likely to achieve success by diminishing the incidence of infection during the initial 3 months after implantation. Rotary (continuous-flow) pumps are expected to have lower infection rates, but this remains to be seen.

Clinical management of continuous-flow left ventricular assist devices in advanced heart failure.

Continuous-flow left ventricular assist devices (LVAD) have emerged as the standard of care for advanced heart failure patients requiring long-term mechanical circulatory support. Evidence-based clinical management of LVAD-supported patients is becoming increasingly important for optimizing outcomes. In this state-of-art review, we propose key elements in managing patients supported with the new continuous-flow LVADs. Although most of the presented information is largely based on investigator experience during the 1,300-patient HeartMate II clinical trial, many of the discussed principles can be applied to other emerging devices as well. Patient selection, pre-operative preparation, and the timing of LVAD implant are some of the most important elements critical to successful circulatory support and are principles universal to all devices. In addition, proper nutrition management and avoidance of infectious complications can significantly affect morbidity and mortality during LVAD support. Optimizing intraoperative and peri-operative care, and the monitoring and treatment of other organ system dysfunction as it relates to LVAD support, are discussed. A multidisciplinary heart failure team must be organized and charged with providing comprehensive care from initial referral until support is terminated. Preparing for hospital discharge requires detailed education for the patient and family or friends, with provisions for emergencies and routine care. Implantation techniques, troubleshooting device problems, and algorithms for outpatient management, including the diagnosis and treatment of related problems associated with the HeartMate II, are discussed as an example of a specific continuous-flow LVAD. Ongoing trials with other continuous-flow devices may produce additional information in the future for improving clinical management of patients with these devices.

Cardiac transplantation and/or mechanical circulatory support device placement using heparin anti-coagulation in the presence of acute heparin-induced thrombocytopenia.

BACKGROUND: Patients with congestive heart failure, decreased left ventricular function, and debilitation are frequently maintained on anti-coagulants, including heparin. As such, these patients are at high risk for developing heparin-induced thrombocytopenia (HIT). Some of these HIT-positive individuals will ultimately undergo urgent heart transplantation or placement of a mechanical circulatory support device (MCSD). Such procedures require cardiopulmonary bypass (CPB) and full anti-coagulation. The safety of re-exposure to heparin during CPB despite the presence of recent-onset thrombocytopenia and Hep/PF4 antibodies has not been studied in the transplant or MCSD populations. METHODS: Over a 24-month period, 75 heart transplants and 55 MCSD implants were performed. Fourteen patients with acute HIT (thrombocytopenia and positive Hep/PF4 antibody by enzyme-linked immunosorbent assay [ELISA]) and 3 patients with a history of remote HIT underwent cardiac transplantation (n = 9) and/or MCSD placement (n = 8) using heparin as the anti-coagulant during CPB. The median time from diagnosis to CPB was 4.5 days in patients with acute HIT. RESULTS: Thirty-day survival was 100% in transplant patients and 75% in MCSD patients. Post-transplant ELISA testing was found to be negative in 4 patients with acute HIT and 3 with remote HIT. CONCLUSIONS: This series demonstrates that short-term re-exposure to heparin during urgent CPB for heart transplantation or MCSD placement is safe despite the presence of thrombocytopenia and Hep/PF4 antibodies. Moreover, the rapid clearance of Hep/PF4 antibodies in our transplant patients suggests a potential therapeutic role for immunosuppressive therapy in the management of HIT in the acute setting.

Simple method to eliminate interference between ventricular assist devices and cardiac rhythm devices.

BACKGROUND: Report on a simple solution to allow programming of defibrillators in the presence of a Heartmate II (Thoratec Corporation, Pleasanton, CA, USA) ventricular assist device. Ventricular assist devices have become increasingly utilized for patients waiting for heart transplantation as well as those who will be maintained on a permanent support. The Heartmate II, which was recently given Food and Drug Administration approval as a bridge-to-transplant device, has a particular anomaly that complicates patient management. The pulse width modulator of the Heartmate II produces electromagnetic noise that interferes with the ability to interrogate and program certain defibrillators, and explantation of the defibrillator has been reported as the only viable solution. METHODS: The authors describe the use of cast-iron pans to reduce the electromagnetic interference between St. Jude Medical's first-generation Atlas family of defibrillators (St. Jude Medical, St. Paul, MN, USA) and the Heartmate II pump. RESULTS: The use of a simple shielding protocol avoids the need to remove a pre-existing defibrillator from a patient receiving support from the Heartmate II ventricular assist device. CONCLUSIONS: The method described herein is important as future generations of medical devices may present different types of device-device interactions. Simple bedside methods to eliminate interference can potentially help patients who would otherwise need one or another device removed.

Randomized trial of tacrolimus monotherapy: tacrolimus in combination, tacrolimus alone compared (the TICTAC trial).

BACKGROUND: Prior retrospective studies have suggested that tacrolimus monotherapy is an option associated with excellent outcomes and reduced toxicities. METHOD: We conducted a prospective, randomized, 2-center study of tacrolimus combination therapy vs monotherapy. From April 16, 2004, to September 15, 2005, 58 adult heart transplant patients were studied. All received oral tacrolimus, mycophenolate mofetil, and corticosteroids. Patients were then randomized to a group where mycophenolate was maintained (COMBO) or to a group where it was discontinued (MONO) 14 days post-transplant. Corticosteroids were rapidly withdrawn in both groups between 8 and 12 weeks. RESULT: The primary end point (mean 6-month International Society of Heart and Lung Transplantation biopsy score) was 0.44 +/- 0.04 in the MONO group and 0.60 +/- 0.05 in the COMBO group (p = 0.013, unpaired Student's t-test). The freedom from rejection grade of 2R or higher at 6 and 12 months was 93.3% with MONO and 92.9% with COMBO (p = NS). CONCLUSION: Tacrolimus monotherapy appears to be safe and efficacious in heart transplant recipients and is not associated with excess rejection in the first year post-transplant. Further studies of this approach are warranted.

A decade of short-term outcomes in post cardiac surgery ventricular assist device implantation: data from the Society of Thoracic Surgeons' National Cardiac Database.

BACKGROUND: Previous studies showed 75% mortality before hospital discharge in patients with a ventricular assist device (VAD) placed for post-cardiac surgery shock. We examined a large national clinical database to assess trends in the incidence of post-cardiac surgery shock requiring VAD implantation, survival rates, and risk factors for mortality. METHODS AND RESULTS: We identified patients undergoing a VAD procedure after cardiac surgery at US hospitals participating in the Society of Thoracic Surgeons' National Cardiac Database during the years 1995 to 2004. Baseline characteristics and operative outcomes were analyzed in 2.5-year increments. Logistic regression modeling was performed to provide risk-adjusted operative mortality and morbidity odds ratios. A total of 5735 patients had a VAD placed during the 10-year period (0.3% cardiac surgeries). Overall survival rate to discharge after VAD placement was 54.1%. With the earliest period (January 1995 through June 1997) used as reference, the mortality odds ratio declined to 0.72 (July 1997 through December 1999) and eventually to 0.41 (July 2002 through December 2004; P<0.0001). The combined mortality/morbidity odds ratio also declined, to 0.84 and 0.48 over identical periods (P<0.0001). Preoperative characteristics associated with increased mortality were urgency of procedure, reoperation, renal failure, myocardial infarction, aortic stenosis, female sex, race, peripheral vascular disease, New York Heart Association class IV, cardiogenic shock, left main coronary stenosis, and valve procedure (c index=0.755). CONCLUSIONS: After adjustment for clinical characteristics of patients requiring mechanical circulatory support, rates of survival to hospital discharge have improved dramatically. Insertion of a VAD for post-cardiac surgery shock is an important therapeutic intervention that can salvage most of these patients.