Two-Year Follow Up of the LATERAL Clinical Trial: A Focus on Adverse Events.

BACKGROUND: The LATERAL trial validated the safety and efficacy of the thoracotomy approach for implantation of the HeartWare HVAD System, leading to Food and Drug Administration approval. We sought to analyze 24-month adverse event (AE) rates, including a temporal analysis of the risk profile, associated with the thoracotomy approach for the HVAD system. METHODS: AEs from the LATERAL trial were evaluated over 2 years postimplant. Data was obtained from the Interagency Registry for Mechanically Assisted Circulatory Support database for 144 enrolled United States and Canadian patients. Temporal AE profiles were expressed as events per patient year. RESULTS: During 162.5 patient years of support, there were 25 driveline infections (0.15 events per patient year), 50 gastrointestinal bleeds (0.31 events per patient year), and 21 strokes (0.13 events per patient year). Longitudinal AE analysis at follow-up intervals of <30 and 30 to 180 days, and 6 to 12 and 12 to 24 months revealed the highest AE rate at <30 days, with a decrease in total AEs within the first 6 months. After 6 months, most AE rates either stabilized or decreased through 2 years, including a 95% overall freedom from disabling stroke. CONCLUSIONS: Two-year follow-up of the LATERAL trial revealed a favorable morbidity profile in patients supported with the HVAD system, as AE rates were more likely to occur in the first 30 days postimplant, and overall AE rates were significantly reduced after 6 months. Importantly, 2-year freedom from disabling stroke was 95%. These data further support the improving AE profile of patients on long-term HVAD support. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02268942.

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.

Adverse Event Rates Change Favorably Over Time for Patients Bridged With the HeartWare Left Ventricular Assist Device.

The HeartWare Ventricular Assist System (HVAD) provides significant improvements in survival and quality of life, and here, we seek to evaluate temporal differences in the adverse event (AE) rates. Patients (n = 382) in the ADVANCE bridge-to-transplant and continued access protocol trial were assessed for bleeding, cardiac arrhythmia, infection, ischemic and hemorrhagic stroke, and right heart failure during predetermined time periods (≤30, >30-180, >180-365, >365-730, >730-1,095 days) after HVAD implant. The Kaplan-Meier survival at 30 days, 6 months, 1, 2, and 3 years was 98%, 90%, 84%, 71%, and 63%, respectively. There were significantly fewer total AEs in days >30-180 (events per patient year [EPPY] = 5.34) compared with the first 30 days post HVAD implantation (EPPY = 30.36; p < 0.0001). The total AE rate in days >180-365 (EPPY = 4.09) was also significantly lower than the event rate in days >30-180 (EPPY = 5.34; p < 0.0001). Incidence of cardiac arrhythmias, infections, strokes, and right heart failure were highest immediately post implant and lower rates occurred after 6 months. After 1 year, all AEs exhibited stable rates that were comparable up to 3 years of support (all p > 0.05). This changing risk over time has clinically meaningful implications toward improving patient management.

Invasive fungal infection after heart transplantation: A 7-year, single-center experience.

BACKGROUND: Invasive fungal infections (IFIs) are an infrequent but major complication of heart transplantation (HT). We sought to describe the epidemiology at our institution. METHODS: A prospective cohort study of 159 heart transplant recipients was performed from June 2005 to December 2012. IFIs were defined by European Organization for Research and Treatment of Cancer/Mycoses Study Group criteria. RESULTS: By univariate analysis, Hispanic ethnicity was associated with IFI (P=.01, odds ratio [OR] 7.0, 95% confidence interval [CI] 1.7-27.9). Subsequently, a multivariate logistic regression was performed adjusting for Hispanic ethnicity, age, and gender. Seventeen IFIs were identified, occurring at a median 110 days post HT (interquartile range: 32-411 days). Five IFIs (29% of IFIs and 3.1% of all HT) occurred during the HT hospitalization, with 13 IFIs during the first year (incidence 8.2%). CONCLUSIONS: The cumulative incidence was 10.7%. IFIs were associated with pre- and post-HT vancomycin-resistant Enterococcus colonization and/or infection, post-HT renal replacement therapy, anti-thymocyte globulin induction, and antibody-mediated rejection. There were no associations with diabetes mellitus, desensitization, 2R/3R cellular rejection, treatments for rejection, re-operation, neutropenia, or cytomegalovirus infection. IFIs were associated with death (P=.02, OR 3.9, 95% CI 1.3-12.1) and 1-year mortality (P<.001, OR 9.0, 95% CI 2.3-35.7), but not 3-year mortality. Associations with Hispanic ethnicity must be validated. Optimal strategies for risk reduction and prophylaxis remain undefined.

Gender differences in appraisal of stress and coping 5 years after heart transplantation.

OBJECTIVES: We examined whether gender differences exist regarding stress, symptom distress, coping, adherence, and social support 5 years after heart transplantation. BACKGROUND: Differences exist in health-related quality of life outcomes by gender after heart transplantation; women report poorer outcomes. METHODS: Patients (n = 210, female = 42), were from a prospective, multi-site, study of health-related quality of life long-term after heart transplantation. Patients completed self-report instruments 5 years after heart transplantation (mean = 4.98 ± 0.17 years after transplant). Statistical analyses included two-sample t-tests, Chi-square or Fisher's exact test, and multivariable modeling. RESULTS: Women did not report more overall stress or symptom distress, but reported more difficulty adhering to the transplant regimen, yet more actual adherence than men. Women reported using more negative coping styles, but reported more satisfaction with social support. CONCLUSIONS: Gender differences exist regarding appraisal of stress, coping styles, and coping resources long-term after heart transplantation. These differences may guide tailoring therapy regarding stress, poor coping, and lack of resources.

The HVAD Left Ventricular Assist Device: Risk Factors for Neurological Events and Risk Mitigation Strategies.

OBJECTIVES: The purpose of this study was to determine the risk factors for ischemic in hemorrhage cerebrovascular events in patients supported by the HeartWare ventricular assist device (HVAD). BACKGROUND: Patients supported with left ventricular assist devices are at risk for both ischemic and hemorrhagic cerebrovascular events. METHODS: Patients undergoing implantation with a HVAD as part of the bridge-to-transplant trial and subsequent continued access protocol were included. Neurological events (ischemic cerebrovascular accidents [ICVAs] and hemorrhagic cerebrovascular accidents [HCVAs]) were assessed, and the risk factors for these events were evaluated in a multivariable model. RESULTS: A total of 382 patients were included: 140 bridge-to-transplant patients from the ADVANCE (Evaluation of the HeartWare Left Ventricular Assist Device for the Treatment of Advanced Heart Failure) clinical trial and 242 patients from the continued access protocol. Patients had a mean age of 53.2 years; 71.2% were male, and 68.1% were white. Thirty-eight percent had ischemic heart disease, and the mean duration of support was 422.7 days. The overall prevalence of ICVA was 6.8% (26 of 382); for HCVA, it was 8.4% (32 of 382). Pump design modifications and a protocol-driven change in the antiplatelet therapy reduced the prevalence of ICVA from 6.3% (17 of 272) to 2.7% (3 of 110; p = 0.21) but had a negligible effect on the prevalence of HVCA (8.8% [24 of 272] vs. 6.4% [7 of 110]; p = 0.69). Multivariable predictors of ICVA were aspirin ≤81 mg and atrial fibrillation; predictors of HCVA were mean arterial pressure >90 mm Hg, aspirin ≤81 mg, and an international normalized ratio >3.0. Eight of the 30 participating sites had established improved blood pressure management (IBPM) protocols. Although the prevalence of ICVA for those with and without IBPM protocols was similar (5.3% [6 of 114] vs. 5.2% [14 of 268]; p = 0.99), those with IBPM protocols had a significantly lower prevalence of HCVA (1.8% [2 of 114] vs. 10.8% [29 of 268]; p = 0.0078). CONCLUSIONS: Anticoagulation, antiplatelet therapy, and blood pressure management affected the prevalence of cerebrovascular events after implantation of the HVAD. Attention to these clinical parameters can have a substantial impact on the occurrence of serious neurological events. (Evaluation of the HeartWare Left Ventricular Assist Device for the Treatment of Advanced Heart Failure [ADVANCE]; NCT00751972).

Health-related quality of life in mechanical circulatory support: Development of a new conceptual model and items for self-administration.

BACKGROUND: Generic and heart failure (HF)-specific health-related quality of life (HRQOL) instruments do not address unique burdens of mechanical circulatory support (MCS). This report describes (1) a conceptual model of adjustment to MCS and HRQOL, (2) the development of a new set of items to assess adjustment and HRQOL, and (3) establishes content validity of the new model and items. METHODS: We interviewed 15 expert clinicians, 16 patients with advanced HF, and 48 MCS patients. A grounded theory approach was used to systemically examine qualitative data. We developed a coding dictionary, with codes organized under concepts. A conceptual model of adjustment to MCS and HRQOL was developed. A set of relevant items was generated from the codes, concepts, and conceptual model. After items were refined, MCS patients participated in cognitive interviews to provide feedback on their relevance and acceptability. RESULTS: Patients described how having HF and MCS affected their daily lives. Three concepts regarding adjustment to MCS and its relationship to HRQOL emerged: (1) effect of disease and treatment (satisfaction with treatment, symptoms, and self-efficacy regarding self-care), (2) resources, and (3) implant strategy. From our codes, concepts, and model, we developed a set of 652 items that were categorized by concept. The item set was reduced from 652 items to 236 (36%), and 120 of these 236 items (51%) underwent cognitive debriefing. Our final set includes 239 items with evidence of content validity. CONCLUSIONS: Our newly developed model on adjustment to MCS and HRQOL and items will undergo further testing in the future.

An examination of survival by sex and race in the HeartWare Ventricular Assist Device for the Treatment of Advanced Heart Failure (ADVANCE) Bridge to Transplant (BTT) and continued access protocol trials.

BACKGROUND: The Ventricular Assist Device for the Treatment of Advanced Heart Failure (ADVANCE) Bridge to Transplant (BTT) trial was a multicenter, prospective trial of the HeartWare Ventricular Assist Device (HVAD). The performance of the HVAD in various demographic sub-groups was evaluated. METHODS: Baseline characteristics, adverse events, and survival were compared for men vs. women and whites vs. non-whites in the combined ADVANCE BTT and continued access protocol trial. Of 332 patients enrolled in these trials, 236 were men and 96 women, with 228 whites and 104 non-whites. RESULTS: At baseline, women had a smaller body surface area (1.8 ± 0.2 vs. 2.1 ± 0.3 m2, p < 0.0001), less hypertension (50.0% vs. 61.9%, p = 0.05), and less ischemic cardiomyopathy (15.6% vs. 45.3%, p < 0.0001). Differences in Kaplan-Meier survival were not significant at 180 days (men, 91.8%; women, 91.7%) and 1 year (men, 85.3%; women, 85.1%) despite adjustment for baseline differences. Men had a lower incidence of early right heart failure and renal and respiratory dysfunction, and a shorter length of stay. In the analysis by race, non-whites were younger than whites and had less ischemic heart failure, more hypertension, and lower creatinine levels at baseline. Non-whites had lower rates of arrhythmia, bleeding requiring rehospitalization, and device malfunctions than whites. Survival was high in non-whites and whites, at 94.1% vs. 90.4% at 180 days and 89.2% vs. 82.8% at 1 year, respectively, despite adjustment for baseline differences. CONCLUSIONS: Although heart failure etiology differed between men and women and between whites and non-whites, sex and race were not factors that affected survival in patients receiving the HVAD as BTT, which was high in all sub-groups.

Change in health-related quality of life from before to after destination therapy mechanical circulatory support is similar for older and younger patients: analyses from INTERMACS.

BACKGROUND: Destination therapy left ventricular assist devices (DT LVADs) are being implanted in older adults on an increasing basis. Older patients have a higher risk for mortality and morbidity post-LVAD, which may impact their health-related quality of life (HRQOL). We aimed to determine the change in HRQOL by age from before implant to 1 year after DT LVAD implant and identify factors associated with the change. METHODS: Data were collected from 1,470 continuous-flow DT LVAD patients at 108 institutions participating in INTERMACS from January 21, 2010 to March 31, 2012. Patients were divided into three cohorts: <60 years of age (n = 457); 60 to 69 years of age (n = 520); and ≥70 years of age (n = 493). HRQOL was measured using the generic EuroQol instrument (EQ-5D-3L). Data were collected pre-implant and 3, 6 and 12 months post-implant. Statistical analyses included descriptive statistics, Kaplan-Meier survival analyses and multivariable regression analyses. RESULTS: HRQOL improved in all patients. Generally, older patients reported better HRQOL than younger patients pre-implant (≥70 years: mean 40; 60 to 69 years: mean 33; and <60 years: mean 31; p < 0.0001) and 1 year post-implant (≥70 years: mean 77; 60 to 69 years: mean 72; <60 years: mean 70; p = 0.01) using the EQ-5D visual analog scale (VAS), with 0 = worst imaginable health state and 100 = best imaginable health state. The magnitude of improvement in EQ-5D scores from pre-implant to 1-year post-LVAD implant was similar in all age groups (≥70 years: mean change 33; 60 to 69 years: mean change 35; <60 years: mean change 35; p = 0.77). Factors associated with improvement in HRQOL from before to 1 year after implant were a lower VAS score pre-implant and fewer rehospitalizations post-implant (R(2) = 61.3%, p < 0.0001). CONCLUSIONS: Older patients reported better HRQOL than younger patients before and after LVAD implantation. The magnitude of improvement was similar for all age groups, with >70% of all patients showing clinically significant increases (>10 points on the VAS). Rehospitalization appears to reduce the magnitude of improvement.

Percutaneous closure of the aortic valve as a bridge to heart transplantation to treat severe aortic insufficiency after ventricular assist device.

Aortic insufficiency (AI) following rotary left ventricular assist device (LVAD) implantation is an increasingly common problem with inadequately defined treatment options. Percutaneous transcatheter (PTC) closure of the aortic valve (AV) has been described as a potential nonsurgical approach. Alternatively, we present a case of decompensated heart failure due to de novo severe AI following LVAD in which successful PTC closure of the AV resolved the severe AI and allowed for clinical recovery and stability for more than 10 months as a bridge to heart transplantation.

Mortality while waiting for aortic valve replacement.

BACKGROUND: Severe symptomatic aortic stenosis (AS) is associated with high mortality without intervention. The impact of waiting time for aortic valve replacement (AVR), either surgically or transcatheter, has not been reported. METHODS: From January 2008 to December 2012, we identified 1,005 patients with severe symptomatic AS. AVR was recommended for 823 patients (82%). Of these 823 patients, 721 (87.6%) underwent AVR. We modeled overall survival (OS) since AVR recommendation or intervention date using Cox and multistate models. RESULTS: Overall, the median (first, third quartiles) waiting time until operation was 2.9 (1.3, 5.1) weeks. Mortality at these times was lower (p<0.001) in the AVR group (1.2%, 0.3%, 1.7%, respectively) than in the group that did not receive AVR (6.9%, 2.9%, 9.8%, respectively). Thirty-day mortality after AVR was 3.9% (3.2% surgical AVR [SAVR] and 7.0% transcatheter AVR [TAVR]). In patients receiving AVR, waiting time was not associated with increased mortality. Mortality while waiting for AVR was 3.7% and 11.6% at 1 and 6 months, respectively. Mortality while waiting for TAVR was higher than that for SAVR (1-, 6-, and 12-month mortality of 3.7%, 8.0%, and 9.6%, respectively, in SAVR group and 3.8%, 23.3%, and 27.5%, respectively, in TAVR group; p<0.001). CONCLUSIONS: Some patients do not receive AVR in a timely fashion, and prolonged waiting time for AVR is associated with mortality greater than the AVR operative mortality. Although waiting time was not associated with poor operative outcomes after AVR, many patients may die while waiting for AVR. Patients should receive AVR on a semiurgent, not elective, basis.

Predictors of hospital length of stay after implantation of a left ventricular assist device: an analysis of the INTERMACS registry.

BACKGROUND: Few studies have reported on hospital length of stay (LOS) after left ventricular assist device (LVAD) implantation. The purpose of this study was to determine pre- and peri-operative predictors of hospital LOS after LVAD implantation. METHODS: We analyzed adult primary continuous-flow LVAD patients implanted between June 23, 2006 and December 31, 2010 at 105 institutions from the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS). Retrospective analyses included measures of central tendency, frequencies, correlations and stepwise multivariable regression modeling (p ≤ 0.05). Independent variables included demographic characteristics, pre-implant clinical and behavioral variables and concomitant surgery. RESULTS: Characteristics of the patients (n = 2,200) included: mean age 54.6 ± 12.6 years; 79% male; 69% white; 57% INTERMACS Profile 1 or 2; 37% diabetic; 21% with history of coronary artery bypass graft (CABG); 7% with history of valve surgery; and 37% with concomitant surgery. Median hospital LOS (implant to discharge) was 20 days. Significant predictors of an increased hospital LOS included demographic characteristics (older age and non-white), pre-implant clinical variables (history of CABG or valve surgery, diabetes, ascites, INTERMACS Profiles 1 and 2, low albumin, high blood urea nitrogen, high right atrial pressure) and concomitant surgery, explaining 12% variance (F = 22.65, p<0.001). CONCLUSIONS: Demographic characteristics, pre-implant variables and concomitant surgery partially explained hospital LOS after continuous-flow LVAD implant. These variables have implications regarding selection of patients for mechanical circulatory support.

An analysis of pump thrombus events in patients in the HeartWare ADVANCE bridge to transplant and continued access protocol trial.

BACKGROUND: The HeartWare left ventricular assist device (HVAD, HeartWare Inc, Framingham, MA) is the first implantable centrifugal continuous-flow pump approved for use as a bridge to transplantation. An infrequent but serious adverse event of LVAD support is thrombus ingestion or formation in the pump. In this study, we analyze the incidence of pump thrombus, evaluate the comparative effectiveness of various treatment strategies, and examine factors pre-disposing to the development of pump thrombus. METHODS: The analysis included 382 patients who underwent implantation of the HVAD as part of the HeartWare Bridge to Transplant (BTT) and subsequent Continued Access Protocol (CAP) trial. Descriptive statistics and group comparisons were generated to analyze baseline characteristics, incidence of pump thrombus, and treatment outcomes. A multivariate analysis was performed to assess significant risk factors for developing pump thrombus. RESULTS: There were 34 pump thrombus events observed in 31 patients (8.1% of the cohort) for a rate of 0.08 events per patient-year. The incidence of pump thrombus did not differ between BTT and CAP. Medical management of pump thrombus was attempted in 30 cases, and was successful in 15 (50%). A total of 16 patients underwent pump exchange, and 2 underwent urgent transplantation. Five patients with a pump thrombus died after medical therapy failed, 4 of whom also underwent a pump exchange. Survival at 1 year in patients with and without a pump thrombus was 69.4% and 85.5%, respectively (p = 0.21). A multivariable analysis revealed that significant risk factors for pump thrombus included a mean arterial pressure > 90 mm Hg, aspirin dose ≤ 81 mg, international normalized ratio ≤ 2, and Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) profile level of ≥ 3 at implant. CONCLUSIONS: Pump thrombus is a clinically important adverse event in patients receiving an HVAD, occurring at a rate of 0.08 events per patient-year. Significant risk factors for pump thrombosis include elevated blood pressure and sub-optimal anti-coagulation and anti-platelet therapies. This suggests that pump thrombus event rates could be reduced through careful adherence to patient management guidelines.

Should paroxysmal atrial fibrillation be treated during cardiac surgery?

OBJECTIVES: Randomized controlled trials of permanent atrial fibrillation ablation surgery have shown improved outcomes compared with control patients undergoing concomitant cardiac surgery. Little has been reported regarding patients with paroxysmal atrial fibrillation. We hypothesized that treating paroxysmal atrial fibrillation during cardiac surgery would not adversely affect the perioperative risk and would improve the midterm outcomes. METHODS: From April 2004 to June 30 2012, 4947 patients (excluding those with transcatheter aortic valve implants, left ventricular assist devices, trauma, transplantation, and isolated atrial fibrillation surgery) underwent cardiac surgery, and 1150 (23%) had preoperative atrial fibrillation. Of these, 552 (48%) had paroxysmal atrial fibrillation. Three groups were compared using propensity score matching: treated (n = 423, 77%), untreated (n = 129, 23%), and no atrial fibrillation (n = 3797). RESULTS: The treated patients had 30-day mortality similar to that of the untreated patients and those without atrial fibrillation. They had fewer perioperative complications (26% vs 46%, P = .001), greater freedom from atrial fibrillation at the last follow-up visit (81% vs 60%, P = .007), and lower mortality (hazard ratio 0.47, P = .007) compared with the untreated patients. Compared with those without atrial fibrillation, the treated patients had fewer perioperative complications (25% vs 48%, P < .001), lower freedom from atrial fibrillation at the last follow-up visit (84% vs 93%, P = .001), and similar mortality. CONCLUSIONS: Concomitant surgical ablation of paroxysmal atrial fibrillation was not associated with increased perioperative risk. The treated patients had greater late freedom from atrial fibrillation and midterm survival compared with the untreated patients, and similar midterm survival compared with the patients without atrial fibrillation. These results suggest that paroxysmal atrial fibrillation warrants treatment consideration in select patients undergoing cardiac surgery.

HeartWare ventricular assist system for bridge to transplant: combined results of the bridge to transplant and continued access protocol trial.

BACKGROUND: The HeartWare Ventricular Assist System (HeartWare Inc, Framingmam, MA) is a miniaturized implantable, centrifugal design, continuous-flow blood pump. The pivotal bridge to transplant and continued access protocols trials have enrolled patients with advanced heart failure in a bridge-to-transplant indication. METHODS: The primary outcome, success, was defined as survival on the originally implanted device, transplant, or explant for ventricular recovery at 180 days. Secondary outcomes included an evaluation of survival, functional and quality of life outcomes, and adverse events. RESULTS: A total of 332 patients in the pivotal bridge to transplant and continued access protocols trial have completed their 180-day primary end-point assessment. Survival in patients receiving the HeartWare pump was 91% at 180 days and 84% at 360 days. Quality of life scores improved significantly, and adverse event rates remain low. CONCLUSIONS: The use of the HeartWare pump as a bridge to transplant continues to demonstrate a high 180-day survival rate despite a low rate of transplant. Adverse event rates are similar or better than those observed in historical bridge-to-transplant trials, despite longer exposure times due to longer survival and lower transplant rates.

Demographic, psychosocial, and behavioral factors associated with survival after heart transplantation.

BACKGROUND: Heart transplantation requires substantial personal, financial, and psychosocial resources. Using an existing multisite data set, we examined predictors of mortality at 5 to 10 years after heart transplantation. METHODS: All 555 participants completed a self-report quality of life instrument. Of these patients, 55 (10%) died 5 to 10 years after heart transplantation. Statistical analyses included frequencies, means, Pearson correlation coefficients, and Cox proportional hazard modeling. RESULTS: Educational level and higher levels of social and economic satisfaction were predictive of improved survival. Conversely, married status, more cumulative infections, the presence of hematologic disorders, higher New York Heart Association (NYHA) class, and poor adherence to medical care predicted worse survival. CONCLUSIONS: Demographic, clinical, psychosocial, and behavioral factors were important predictors of long-term survival after heart transplantation. These findings have important implications for patient selection for heart transplantation, as well as for posttransplantation care.

Late neurologic events after surgery for atrial fibrillation: rare but relevant.

BACKGROUND: The classic cut and sew maze is thought to reduce stroke, in part because of left atrial appendage (LAA) elimination. Multiple LAA elimination techniques have evolved with the introduction of new surgical treatment options for atrial fibrillation (AF), but the impact on stroke remains unknown. We studied the rate of late neurologic event (LNE) in the era of contemporary AF surgery. METHODS: From April 21, 2004, to June 30, 2011, 773 patients underwent surgery for AF. In 131 patients, the LAA was excised. In 579, alternative elimination techniques were used (97 external ligation, 313 internal ligation, 126 stapled excision, 23 stapled excision plus internal ligation, 5 internal plus external ligations, and 15 that did not fit into any category); 63 LAAs were left intact and excluded from analyses. Complete follow-up was obtained by medical record review and phone call. Median survival follow-up was 3.3 years (first and third quartiles, 1.6 and 5.0). An LNE was defined as either a documented stroke or transient ischemic attack 30 or more days after surgery. Baseline characteristics and outcomes between LAA techniques were compared using χ(2), Fisher's exact tests, and Student's t tests. RESULTS: There were 25 LNEs (3.5%) overall; the median occurrence time was 3.6 years (first and third quartiles, 1.9 and 5.4) after surgery. There were 17 strokes and 8 transient ischemic attacks. Of 45 demographic and surgical variables, only age, aortic valve surgery, and perioperative neurologic event (<30 days after cardiac surgery) independently predicted LNE (p = 0.003, 0.021, and 0.010, respectively). Late neurologic events occurred with an annual rate of 1.13% in patients with alternative elimination techniques, and 0.20% in patients with excised LAA (p = 0.001). Patients in AF at any time were more likely to have LNE, but this was not an independent predictor. CONCLUSIONS: After surgery for AF ablation, there is ongoing low risk of LNE even when the LAA is surgically excised. Further investigation should be pursued to clarify whether a difference exists with alternative elimination techniques and in patients in whom AF is successfully eliminated.