Mechanical circulatory support for cardiac amyloidosis.

BACKGROUND: Cardiac amyloidosis, typically from abnormal deposition of AL or ATTR amyloid protein, can result in heart failure requiring transplantation (HTx). The role of mechanical circulatory support (MCS) is not well-established. The purpose of this study was to present our experience with MCS in patients with cardiac amyloidosis. METHODS: Consecutive patients with cardiac amyloidosis who received MCS at Cedars-Sinai Medical Center between 2010 and 2018 were reviewed. Clinical characteristics and outcomes were compared to a control group of MCS patients without amyloid matched 2:1 for age and INTERMACS Profile. RESULTS: 11 amyloid patients underwent durable MCS, two with paracorporeal biventricular assist devices and 9 with total artificial hearts. No patients received isolated left ventricular assist device support. By 1 year, 9 (82%) of patients in the MCS-Amyloid group had been transplanted and 2 (18%) had died. In the MCS-No Amyloid group, by 1 year, 8 (36%) of patients had been transplanted, 10 (46%) had died, and 4 (18%) were still living with MCS. CONCLUSIONS: Over a 9-year period, patients with amyloid cardiomyopathy who required MCS at our institution all received durable biventricular MCS. For carefully selected patients, this approach is feasible with acceptable outcomes as bridge to transplantation.

Device Strategies for Patients in INTERMACS Profiles 1 and 2 Cardiogenic Shock: Double Bridge With Extracorporeal Membrane Oxygenation and Initial Implant of More Durable Devices.

For Interagency Registry for Mechanically Assisted Circulatory Support profiles 1 and 2 cardiogenic shock patients initially placed on extracorporeal membrane oxygenation (ECMO), whether crossover to more durable devices is associated with increased survival, and its optimal timing, are not established. Profiles 1 and 2 patients placed on mechanical support were prospectively registered. Survival and successful hospital discharge were compared between patients placed on ECMO only, ECMO with early crossover, and ECMO with delayed crossover. Survival of patients directly implanted with non-ECMO devices was also reported. One-hundred and sixty-two patients were included. Mean age was 52.2 ± 13.8 years. Seventy-three of 162 (45.1%) were initiated on ECMO. Of these, 43 were supported with ECMO only, 11 were crossed-over early <4 days, and 19 were crossed-over in a delayed fashion. Survival was different across groups (Log-rank P < 0.002). In multivariate analysis, early crossover was associated with decreased mortality as compared with no crossover (hazard ratio [HR] 0.201, 95% confidence interval [95%CI] 0.058-0.697, P = 0.011) or with delayed crossover (HR 0.255, 95%CI 0.073-0.894, P = 0.033). Mortality was not different between delayed crossover and no crossover (P = 0.473). In patients with early crossover there were no deaths at 30 days, and 60-day survival was 90.0 ± 9.5%. Survival to hospital discharge was 72.8%. For patients directly implanted with non-ECMO devices, 30-day and 60-day survival was 90.9 ± 3.1% and 87.3 ± 3.8%, respectively, and survival to hospital discharge was 78.7%. Both initial implant of durable devices and double bridge strategy was associated with improved outcomes. If the double bridge strategy is chosen, early crossover is associated with improved survival and successful hospital discharge.

Mechanical circulatory support in cardiogenic shock following an acute myocardial infarction: a systematic review.

The significance of the utilization of mechanical circulatory support following a myocardial infarction is not well defined. We present a systematic review of this treatment alternative and suggest guidelines to be considered in the treatment of these patients.

Three year post heart transplant outcomes of desensitized durable mechanical circulatory support patients.

BACKGROUND: The risks and benefits of desensitization therapy (DST) in highly sensitized mechanical circulatory support (MCS) patients are not well known. We investigated 3 year post-transplant outcomes of desensitized durable MCS patients. METHODS: Among 689 consecutively enrolled heart transplantation recipients between 2010 and 2016, we categorized them into Group A (desensitized MCS patients, n = 21), Group B (desensitized non-MCS patients, n = 28) and Group C (all nondesensitized patients, n = 640). Post-transplant outcomes included the incidence of primary graft dysfunction, 3-year survival, freedom from cardiac allograft vasculopathy, nonfatal major adverse cardiac events, any treated rejection, acute cellular rejection, antibody mediated rejection (AMR) and infectious complications. RESULTS: The types of DST in Groups A and B were similar and included combinations of rituximab/intravenous immunoglobulin and plasmapheresis/bortezomib. Group A, compared with Group B, showed significantly higher pre-DST panel reactive antibody (PRA) (92.2 ± 9.8 vs. 83.3 ± 15.6, P = 0.007) and higher PRA reduction after DST (-22.2 ± 26.9 vs. -6.3 ± 7.5, P = 0.015). Groups A and C showed comparable primary graft dysfunction, 3-year survival, freedom from cardiac allograft vasculopathy, nonfatal major adverse cardiac events, any treated rejection, acute cellular rejection, and AMR. Although statistically not significant, Group A showed numerically higher 3-year freedom from AMR than Group B. Infectious complications were similar in both Groups A and B. CONCLUSIONS: DST for MCS patients showed significant PRA reduction, resulting in an expansion of the donor pool. The post-transplant outcome of desensitized MCS patients showed comparable clinical outcomes to non-desensitized control patients in the same study period, revealing the safety and efficacy of DST.

"It's not something that's really been brought up": Opportunities and challenges for ongoing advance care planning discussions among individuals living with mechanical circulatory support.

BACKGROUND: People living with mechanical circulatory support (MCS) are at risk for catastrophic complications that require advance care planning (ACP) as part of the preimplantation work up. Palliative care consultants are a mandatory and essential component of the MCS team tasked to enhance conversations. However, in reality, there is often a serious deficiency of ACP communication after the initial implant counseling. A better understanding of opportunities and challenges in ACP can mobilize intensive care unit and step-down nurses to bridge this gap in crucial communication. OBJECTIVES: To identify and describe MCS individuals' perceptions of opportunities and challenges for ongoing ACP communication. METHODS: A constructivist grounded theory study was conducted with 24 MCS individuals from 2 medical centers in Southern California. Semi-structured interviews were audio recorded, transcribed, and reviewed for accuracy. The data were systematically analyzed through 3 rounds of coding. RESULTS: MCS clinicians, supportive others, and peers with MCS were identified as stakeholders in ongoing communication. Four categories of opportunities and challenges for ongoing ACP were synthesized from the narratives: identifying context and timing, sharing information, understanding of ACP, and assessing satisfaction. All participants reported a preference for MCS clinicians, including nurses, to initiate ACP conversations. CONCLUSION: Understanding opportunities and challenges is key to facilitating ongoing ACP discussions among MCS patients. MCS-trained nurses are positioned to address the dearth of ongoing ACP by facilitating these sensitive discussions. The personal accounts of this sample serve to guide future research and structure training to prepare MCS clinicians for primary palliative care.

Post-transplantation outcomes of sensitized patients receiving durable mechanical circulatory support.

BACKGROUND: Sensitization, defined as the presence of circulating antibodies, presents challenges, particularly in patients undergoing heart transplantation (HTx) bridged with durable mechanical circulatory support (MCS). We aimed to investigate the post-transplantation outcomes of sensitized MCS patients. METHODS: Among 889 consecutively enrolled heart transplant (HTx) recipients between 2010 and 2018, 86 (9.7%) sensitized MCS patients (Group A) were compared with sensitized non-MCS patients (Group B, n = 189), non-sensitized MCS patients (Group C, n = 162), and non-sensitized non-MCS patients (Group D, n = 452) regarding post-HTx outcomes, including the incidence of primary graft dysfunction (PGD), 1-year survival, and 1-year freedom from antibody-mediated rejection (AMR). RESULTS: Sensitized MCS patients (Group A) showed comparable rates of PGD, 1-year survival, and 1-year freedom from AMR with Groups C and D. However, Group A showed significantly higher rates of 1-year freedom from AMR (95.3% vs 85.7%, p = 0.02) and an earlier decline in panel-reactive antibody (PRA) levels (p < 0.01) than sensitized non-MCS patients (Group B). Desensitization therapy effectively reduced the levels of PRA in both Groups A and B. When Group A was further divided according to the presence of preformed donor-specific antibodies (DSA), patients with preformed DSA showed significantly lower rates of 1-year freedom from AMR than those without (84.2% vs 98.5%, p = 0.01). CONCLUSIONS: Sensitized MCS patients showed significantly lower rates of AMR and an earlier decline in PRA levels following HTx than sensitized non-MCS patients. Removal of MCS at the time of transplantation might underlie these observations.

The long-term outcome of treated sensitized patients who undergo heart transplantation.

BACKGROUND: Sensitized patients prior to heart transplantation are reportedly at risk for hyperacute rejection and for poor outcome after heart transplantation. It is not known whether the reduction of circulating antibodies pre-transplant alters post-transplant outcome. METHODS AND RESULTS: Between July 1993 and July 2003, we reviewed 523 heart transplant patients of which 95 had pre-transplant panel reactive antibody (PRAs) >10%; 21/95 were treated pre-transplant for circulating antibodies. These 21 patients had PRAs > 10% (majority 50-100%) and were treated with combination therapy including plasmapheresis, intravenous gamma globulin and rituximab to reduce antibody counts. The 74 untreated patients with PRAs > 10% (untreated sensitized group) and those patients with PRAs < 10% (control group) were used for comparison. Routine post-transplant immunosuppression included triple-drug therapy. After desensitization therapy, circulating antibody levels pre-transplant decreased from a mean of 70.5 to 30.2%, which resulted in a negative prospective donor-specific crossmatch and successful heart transplantation. Compared to the untreated sensitized group and the control group, the treated sensitized group had similar five-yr survival (81.1% and 75.7% vs. 71.4%, respectively, p = 0.523) and freedom from cardiac allograft vasculopathy (74.3% and 72.7% vs. 76.2%, respectively, p = 0.850). CONCLUSION: Treatment of sensitized patients pre-transplant appears to result in acceptable long-term outcome after heart transplantation.

Total Artificial Heart as Bridge to Cardiac Retransplantation.

Mechanical circulatory support has been performed as a bridge to cardiac retransplantation in selected patients with graft failure. However, there is limited published experience on the use and potential benefit of the total artificial heart (TAH) as a bridge to cardiac retransplantation. We report on our institutional experience with 3 patients that received TAH as a bridge to retransplant, with 1 patient surviving post-retransplantation. This case series demonstrates the high-risk nature of this undertaking in cardiac retransplant candidates and highlights the issue of sensitization portending greater risk for poor outcomes after TAH as bridge to retransplantation.

The Impact of a High-risk Psychosocial Assessment on Outcomes After Durable Mechanical Circulatory Support.

Patient adherence is vital to the success of durable mechanical circulatory support (MCS), and the pre-MCS assessment of adherence by the multidisciplinary advanced heart failure team is a critical component of the evaluation. We assessed the impact of a high-risk psychosocial assessment before durable MCS implantations on post-MCS outcomes. Between January 2010 and April 2018, 319 patients underwent durable MCS at our center. We excluded those who died or were transplanted before discharge. The remaining 203 patients were grouped by pre-MCS psychosocial assessment: high-risk (26; 12.8%) versus acceptable risk (177; 87.2%). We compared clinical characteristics, nonadherence, and outcomes between groups. High-risk patients were younger (48 vs. 56; p = 0.006) and more often on extracorporeal membrane oxygenation at durable MCS placement (26.9% vs. 9.0%; p = 0.007). These patients had a higher incidence of post-MCS nonadherence including missed clinic appointments, incorrect medication administration, and use of alcohol and illicit drugs. After a mean follow-up of 15.3 months, 100% of high-risk patients had unplanned hospitalizations compared with 76.8% of acceptable-risk patients. Per year, high-risk patients had a median of 2.9 hospitalizations per year vs. 1.2 hospitalizations per year in acceptable-risk patients. While not significant, there were more driveline infections over the follow-up period in high-risk patients (27% vs. 14.7%), deaths (27% vs. 18%), and fewer heart transplants (53.8% vs. 63.8%).The pre-MCS psychosocial assessment is associated with post-MCS evidence of nonadherence and unplanned hospitalizations. Attention to pre-MCS assessment of psychosocial risk factors is essential to optimize durable MCS outcomes.

Assessing Cerebrovascular Hemodynamics Using Transcranial Doppler in Patients with Mechanical Circulatory Support Devices.

BACKGROUND AND PURPOSE: Mechanical circulatory support (MCS) devices are commonly used in heart failure patients. These devices carry risk for presumably embolic and additionally hemorrhagic stroke. Alterations in blood flow play a key role in stroke pathophysiology, and we aimed to learn more about hemodynamic compromise. In this study, we used transcranial Doppler (TCD) ultrasound to define hemodynamics of commonly used nonpulsatile MCS devices, as well as pulsatile devices, with special attention to the total artificial heart (TAH). METHODS: From 2/2013 through 12/2016, we prospectively enrolled patients with MCS who underwent TCD imaging. We analyzed TCD parameters, including peak systolic velocity, end-diastolic velocity, pulsatility indices (PIs), and number of high-intensity transient signals. Waveform morphologies were compared between various MCS devices. RESULTS: We performed 132 TCD studies in 86 MCS patients. Waveforms in patients supported by venoarterial-extracorporeal membrane oxygenation demonstrated continuous flow without clear systolic peaks with an average (±SD) PI of .43 (±.2). PIs were low in patients with continuous-flow left ventricular assist devices with a mean PI of .32 (±.13). Impella patients had morphologically distinct pulsatile waveforms and a higher mean PI of .65 (±.24). In intra-arterial balloon pump patients, mean PI was 1.01 (±.16) and diastolic upstrokes were pronounced. In TAH patients, mean middle cerebral artery velocity of 79.69 (±32.33) cm/seconds and PI of .74 (±.14) approached normal values. CONCLUSION: TCD can detect characteristic waveforms in patients supported by various MCS devices. These device-specific TCD patterns are recognizable and reproducible.

cBIN1 Score (CS) Identifies Ambulatory HFrEF Patients and Predicts Cardiovascular Events.

BACKGROUND: Cardiac Bridging Integrator 1 (cBIN1) is a membrane deformation protein that generates calcium microdomains at cardiomyocyte t-tubules, whose transcription is reduced in heart failure, and is released into blood. cBIN1 score (CS), an inverse index of plasma cBIN1, measures cellular myocardial remodeling. In patients with heart failure with preserved ejection fraction (HFpEF), CS diagnoses ambulatory heart failure and prognosticates hospitalization. The performance of CS has not been tested in patients with heart failure with reduced ejection fraction (HFrEF). METHODS AND RESULTS: CS was determined from plasma of patients recruited in a prospective study. Two comparative cohorts consisted of 158 ambulatory HFrEF patients (left ventricular ejection fraction (LVEF) ≤ 40%, 57 ± 10 years, 80% men) and 115 age and sex matched volunteers with no known history of HF. N-terminal pro-B-type natriuretic peptide (NT-proBNP) concentrations were also analyzed for comparison. CS follows a normal distribution with a median of 0 in the controls, which increases to a median of 1.9 (p < 0.0001) in HFrEF patients. CS correlates with clinically assessed New York Heart Association Class (p = 0.007). During 1-year follow-up, a high CS (≥ 1.9) in patients predicts increased cardiovascular events (43% vs. 26%, p = 0.01, hazard ratio 1.9). Compared to a model with demographics, clinical risk factors, and NT-proBNP, adding CS to the model improved the overall continuous net reclassification improvement (NRI 0.64; 95% CI 0.18-1.10; p = 0.006). Although performance for diagnosis and prognosis was similar to CS, NT-proBNP did not prognosticate between patients whose NT-proBNP values were > 400 pg/ml. CONCLUSION: CS, which is mechanistically distinct from NT-proBNP, successfully differentiates myocardial health between patients with HFrEF and matched controls. A high CS reflects advanced NYHA stage, pathologic cardiac muscle remodeling, and predicts 1-year risk of cardiovascular events in ambulatory HFrEF patients. CS is a marker of myocardial remodeling in HFrEF patients, independent of volume status.

Clinical Outcomes of Impella Microaxial Devices Used to Salvage Cardiogenic Shock as a Bridge to Durable Circulatory Support or Cardiac Transplantation.

Temporary mechanical circulatory support (MCS) can be a bridge to decision for patients in severe cardiogenic shock who may be eligible for durable support or transplantation. Outcomes with Impella microaxial devices for salvage of severe shock in the end-stage heart failure population are not well described. Patients who underwent Impella placement as a bridge to decision, durable MCS, or transplantation were included. Eighty Impella devices (2.5 [1.3%], CP [53.8%], and 5.0 [45.0%]) were placed in 64 patients. Implant age was 56.2 ± 12.5 years. Mean duration of assisted support was 13.2 ± 15.1 days, and median duration per device was 7 days (interquartile range: 3-14). A total of 48.4% were in Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS 1) shock at implant, 51.6% in profile 2. Recent cardiopulmonary resuscitation (CPR) (26.7%), ventilator use (67.2%), and extracorporeal membrane oxygenation (ECMO) use (26.7%) were frequent. Forty four of sixty four (68.8%) survived to next therapy: durable MCS (40.9%), heart transplant (OHT) (36.4%), and recovery (22.7%). Overall 30 and 60 day survival were 67.2% and 65.6%, respectively. Thirty and 60 day survival conditional on having survived to next therapy were 94.1% and 91.2%, respectively. Survivors were less likely to be on ventilators (p = 0.049) or continuous renal replacement therapy (p < 0.001) but were otherwise not different from nonsurvivors by age, sex, INTERMACS profile, CPR, prevalence of ischemic cardiomyopathy, among other characteristics. Sixteen patients were directly bridged to heart transplantation, and all were alive at long-term follow-up. Impella devices can be used to salvage patients in severe heart failure as a bridge to decision, durable MCS, or transplantation. Baseline demographics are not predictive of survival. Their use for this indication is increasing and further investigations are warranted.

Biventricular Support With Intracorporeal, Continuous Flow, Centrifugal Ventricular Assist Devices.

BACKGROUND: The incidence of right ventricular dysfunction requiring right ventricular assist device after left ventricular assist device placement has been reported between 10% to 30%. The mortality rate is higher compared with patients who require left ventricular assist device only; the most effective and safest biventricular assist device remains unknown. We aimed to determine the survival outcomes and frequency of adverse events in patients with two durable, intracorporeal, continuous flow centrifugal pumps for support. METHODS: Between November 2012 and June 2015, 38 patients were identified from INTERMACS received durable, intracorporeal continuous flow centrifugal pumps for biventricular support. Pediatric patients were excluded. Mean age was 47 years, and 74% of patients were male. The common primary diagnoses in this cohort were dilated myopathy, idiopathic (37%) and ischemic (16%). RESULTS: Nineteen participating centers implanted devices in 38 patients; 11 patients died with device in place, 9 patients received a heart transplant, and 18 were alive on support with the right ventricular assist device in place. Survival outcomes were 68% at 6 months and 62% at 12 months. The left ventricular assist device was placed in the left ventricle apex in 91% of cases, and in 9%, the location was not specified. The right ventricular assist device was placed in the right ventricle in 50%, right atrium in 37%, and not specified in 13%. The adverse events included infection 50%, bleeding 44%, respiratory failure 31.6%, and malfunction 26.3%; neurologic dysfunction 26.3%; renal dysfunction 18.4%; and arrhythmia 18.4%. CONCLUSIONS: The use of durable, intracorporeal, continuous flow centrifugal pumps for management of advanced biventricular heart failure is associated with high morbidity and mortality. Further investigation of this device configuration is warranted.

Interagency registry for mechanically assisted circulatory support report on the total artificial heart.

BACKGROUND: We sought to better understand the patient population who receive a temporary total artificial heart (TAH) as bridge to transplant or as bridge to decision by evaluating data from the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) database. METHODS: We examined data related to survival, adverse events, and competing outcomes from patients who received TAHs between June 2006 and April 2017 and used hazard function analysis to explore risk factors for mortality. RESULTS: Data from 450 patients (87% men; mean age, 50 years) were available in the INTERMACS database. The 2 most common diagnoses were dilated cardiomyopathy (50%) and ischemic cardiomyopathy (20%). Risk factors for right heart failure were present in 82% of patients. Most patients were INTERMACS Profile 1 (43%) or 2 (37%) at implantation. There were 266 patients who eventually underwent transplantation, and 162 died. Overall 3-, 6-, and 12-month actuarial survival rates were 73%, 62%, and 53%, respectively. Risk factors for death included older age (p = 0.001), need for pre-implantation dialysis (p = 0.006), higher creatinine (p = 0.008) and lower albumin (p < 0.001) levels, and implantation at a low-volume center (≤10 TAHs; p < 0.001). Competing-outcomes analysis showed 71% of patients in high-volume centers were alive on the device or had undergone transplantation at 12 months after TAH implantation vs 57% in low-volume centers (p = 0.003). CONCLUSIONS: Patients receiving TAHs have rapidly declining cardiac function and require prompt intervention. Experienced centers have better outcomes, likely related to patient selection, timing of implantation, patient care, and device management. Organized transfer of knowledge to low-volume centers could improve outcomes.

Association of a Novel Diagnostic Biomarker, the Plasma Cardiac Bridging Integrator 1 Score, With Heart Failure With Preserved Ejection Fraction and Cardiovascular Hospitalization.

Importance: Transverse tubule remodeling is a hallmark of heart failure. Cardiac bridging integrator 1 (cBIN1) is a circulating membrane scaffolding protein that is essential for transverse tubule health, and its plasma level declines with disease. Objective: To determine if a cBIN1-derived score can serve as a diagnostic biomarker of heart failure with preserved ejection fraction (HFpEF). Design, Setting, and Participants: In this cohort study, the cBIN1 score (CS) was determined from enzyme-linked immunoabsorbent assay-measured plasma cBIN1 concentrations from study participants in an ambulatory heart failure clinic at Cedars-Sinai Medical Center. Consecutive patients with a confirmed diagnosis of heart failure with preserved ejection fraction (HFpEF; defined by a left ventricular ejection fraction ≥50%) were recruited from July 2014 to November 2015 and compared with age-matched and sex-matched healthy volunteers with no known cardiovascular diagnoses and participants with risk factors for heart failure but no known HFpEF. Baseline characteristics and 1-year longitudinal clinical information were obtained through electronic medical records. Data analysis occurred from November 2016 to November 2017. Main Outcomes and Measures: The analysis examined the ability of the CS and N-terminal pro-B-type natriuretic peptide (NT-proBNP) results to differentiate among patients with HFpEF, healthy control participants, and control participants with risk factors for heart failure. We further explored the association of the CS with future cardiovascular hospitalizations. Results: A total of 52 consecutive patients with a confirmed diagnosis of HFpEF were enrolled (mean [SD] age, 57 [15] years; 33 [63%] male). The CS values are significantly higher in the patients with HFpEF (median [interquartile range (IQR)], 1.85 [1.51-2.28]) than in the 2 control cohorts (healthy control participants: median [IQR], -0.03 [-0.48 to 0.41]; control participants with risk factors only: median [IQR], -0.08 [-0.75 to 0.42]; P < .001). For patients with HFpEF, the CS outperforms NT-proBNP when the comparator group was either healthy control participants (CS: area under curve [AUC], 0.98 [95% CI, 0.96-1.00]; NT-proBNP level: AUC, 0.93 [95% CI, 0.88-0.99]; P < .001) or those with risk factors (CS: AUC, 0.98 [95% CI, 0.97-1.00]; NT-proBNP: AUC, 0.93 [95% CI, 0.88-0.99]; P < .001). Kaplan-Meier analysis of 1-year cardiovascular hospitalizations adjusted for age, sex, body mass index, and NT-proBNP levels reveals that patients with HFpEF with CS greater than or equal to 1.80 have a hazard ratio of 3.8 (95% CI, 1.3-11.2; P = .02) for hospitalizations compared with those with scores less than 1.80. Conclusions and Relevance: If further validated, the plasma CS, a marker of transverse tubule dysfunction, may serve as a biomarker of cardiomyocyte remodeling that has the potential to aide in the diagnosis of HFpEF.

Lack of Survival Benefit Found With Use of Intraaortic Balloon Pump in Extracorporeal Membrane Oxygenation: A Pooled Experience of 1517 Patients.

OBJECTIVE: Intraaortic balloon pumps (IABPs) are frequently used as an adjunctive device to extracorporeal membrane oxygenation (ECMO) and are routinely placed at the initiation of ECMO at many institutions. Evidence for the additive benefit of IABP therapy is limited and conflicting in part due to small sample sizes. In the absence of large randomized trials, a meta-analysis would best elucidate potential benefit. METHODS: A systematic PubMed/Medline search was performed. Studies reporting on survival to hospital discharge for cardiogenic shock and cardiac arrest requiring ECMO with an IABP subgroup were included. Concomitant IABP was compared with patients on ECMO alone. Secondary analyses included acute myocardial infarction (AMI) and postcardiotomy cardiogenic shock (PCS) subgroups, as well as timing of IABP insertion. RESULTS: Sixteen studies were included in the main analysis, encompassing 1517 patients. The cumulative survival rate for patients on ECMO was 256/683 (37.5%) compared with 294/834 (35.3%) for patients with adjunctive IABP. Concomitant IABP was not associated with improved survival (risk ratio [RR], 1.143; 95% confidence interval [CI], 0.973-1.343; P=.10). IABP was not associated with improved survival in AMI patients (RR, 1.120; 95% CI, 0.772-1.624; P=.55), PCS (RR, 1.121; 95% CI, 0.826-1.520; P=.46) when placed prior to ECMO initiation (RR, 0.948; 95% CI, 0.718-1.252; P=.71), or when routinely inserted (RR, 1.102; 95% CI, 0.806-1.506; P=.54). CONCLUSION: Based on this observational analysis, the concomitant use of IABP with ECMO did not appear associated with a dramatic change in survival outcomes. The routine insertion of concomitant IABP with ECMO is not supported by our findings.

Use of two recipient lists for adults requiring heart transplantation.

OBJECTIVE: An alternate (second) adult recipient list was used to match excluded potential recipients with nonstandard donor hearts that would otherwise be unused. METHODS: The only absolute criterion for entering the alternate recipient list was age: 65 years old before 1998 and 70 years old after that. Group I consisted of alternates who underwent transplantation, and group II consisted of 401 contemporaneous recipients. Hearts were first offered to regularly listed patients. At least one of the following donor risks accounted for allocation to an alternate: coronary artery disease, reused transplanted heart, high-risk behavior, hepatitis seropositivity, decreased left ventricular ejection fraction, high inotropic requirement, left ventricular hypertrophy, age older than 55 years plus another risk, and small donor with no other matches. RESULTS: Of 102 alternates, 82 were listed were because of age. After a median wait of 107 days, 62 alternates underwent transplantation. Median alternate recipient age was 67 years (vs 54 years, P <.001). Median donor age was 45 years (vs 31 years, P <.001). Survival for alternates at 90 days was 82% (vs 91%, P =.04). Significant recipient predictors of early mortality on multivariable analysis (n = 463) were previous cardiac surgery (odds ratio 2.74, 95% confidence interval 1.37-5.48) and renal dysfunction (odds ratio 1.39, 1.10-176). Alternate listing did not independently predict early or late mortality. Late (>90 days) death rates per 1000 person-months were 4.3 and 3.6 for groups I and II (relative risk 1.2, 0.62-2.36). CONCLUSIONS: Use of two adult recipient lists facilitated allocation of unused donor organs. Satisfactory long-term survival supports the use of an alternate recipient list.

Sudden, unexpected death in cardiac transplant recipients: an autopsy study.

BACKGROUND: Clinical studies indicate that sudden death (SD) is common after heart transplantation. Autopsy reports of such patients are sparse. METHODS: We performed a retrospective study of clinical and pathologic findings on all autopsied patients who underwent heart transplantation at our institution from January 1984 to July 2002. RESULTS: There were 74 patients who survived >2 months. Of these, 28 (37.8%) died suddenly. The major causes of sudden death (SD) included acute cellular rejection (ACR) (n = 11, 39.3%) and graft coronary artery disease (GCAD) (n = 11, 39.3%). In 9 patients (32.1%), there was no anatomic cause of death. These deaths, assumed to be primary arrhythmic death (PAD), occurred 5 to 36 months post-transplantation. Pre-transplant diagnosis of idiopathic dilated cardiomyopathy (IDCM) was more common in SD (13 of 28, 46.4% vs 9 of 46, 19.6%; p = 0.014). Hypertrophy was not statistically different in SD vs non-SD (79.4% vs 88.4%; p = 0.38). Coronary thrombosis was also not statistically different in sudden GCAD deaths vs non-sudden GCAD deaths (3 of 11, 27.3% vs 8 of 13, 61.5%; p = 0.09). ACR SD patients had fewer episodes of ACR in biopsies than ACR non-SD patients (93 of 190, 48.9% vs 99 of 159, 63.3%; p = 0.01). Biopsies with Quilty lesions (QL) were more frequent in patients with SD (206 of 461, 44.7% vs 243 of 710, 34.2%; p < 0.001). QL were more common in patients with GCAD (44.4%) and ACR (39.6%) than in patients who died of infection (25.7%; P < 0.001 and p < 0.01, respectively). CONCLUSIONS: SD after cardiac transplantation is common (37.8% of all deaths). ACR, in the first year, and GCAD, afterwards, are associated with SD. PAD occurred in 32.1% of SD cases, 5 to 36 months after transplantation. Pre-transplant diagnoses of IDCM and QL are more common in SD. Surprisingly, cardiac hypertrophy is not increased and coronary thrombosis is not more frequent in patients who died suddenly.

Machines versus medication for biventricular heart failure: focus on the total artificial heart.

The medical/surgical management of advanced heart failure has evolved rapidly over the last few decades. With better understanding of heart failure pathophysiology, new pharmacological agents have been introduced that have resulted in improvements in survival. For those patients that fail to improve, mechanical circulatory support with left ventricular assist devices and total artificial hearts (TAHs) have served as a beneficial bridge to transplantation. The TAH has continued to play a significant role as a bridge to transplantation in patients with biventricular failure and more selected indications that could not be completely helped with left ventricular assist devices. Improved survival with the TAH has resulted in more patients benefiting from this technology. Improvements will eventually lead to a totally implantable device that will permanently replace the failing human heart.

Donor-recipient sex mismatch portends poor 10-year outcomes in a single-center experience.

BACKGROUND: Several studies have indicated that survival after heart transplantation is affected by donor-recipient sex matching. In most studies, male recipients of a female heart have the poorest survival rates, whereas survival of female recipients is not affected by donor sex. The purpose of the current study was to determine the long-term outcomes of recipients at a large single center on uniform immunosuppression therapy in the current era. METHODS: We reviewed the records of 857 patients transplanted at a single center between 1994 and 2008. Patients were divided into 4 groups based on donor-recipient sex: male donor to male recipient (male/male, n = 506); female donor to female recipient (female/female, n = 113); male donor to female recipient (male/female, n = 106); and female donor to male recipient (female/male, n = 132). Ten-year outcomes were assessed for: survival; freedom from cardiac allograft vasculopathy (CAV); and freedom from non-fatal major adverse cardiac events (NF-MACE). RESULTS: Ten-year actuarial survival was comparable in male/male and female/female groups, at 69% and 71%, respectively (p > 0.05). Compared with the male/male group, 10-year actuarial survival was significantly lower in the sex-mismatch groups: 58% in the male/female group (p = 0.03) and 59% in the female/male group (p = 0.01). There was no significant difference in 10-year freedom from CAV or NF-MACE among the groups. CONCLUSIONS: Heart transplant patients with donor-recipient sex mismatch have lower survival, extending the results of prior studies to suggest that sex mismatch is undesirable in female, as well as male, recipients. This may impact donor selection and recipient wait time to transplantation.