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In June 2021, HVAD System distribution ceased due to observational data demonstrating increased mortality and neurological events compared to another commercial device, and a device malfunction with delay or failure to restart, especially in certain subpopulations. To assess ongoing risk for patients on support following subsequent device recalls, the manufacturer's Intermacs HVAD System 2022 Quarterly Reports were queried to identify mortality and adverse events trends in a contemporary cohort of 3110 primary HVAD implantations since October 2017, stratified by year-of-implant. Mean duration of support was 21 ± 16 months, with 33% alive on original device, 25% transplanted, 6% undergoing device exchange, 4% recovered, and 32% expired. Kaplan–Meier and event-per-patient-year estimates for survival, freedom from device explant, stroke, and pump thrombus were similar across year-of-implant. Following market withdrawal and recent device recalls, there appears to be no increase in mortality, stroke, pump thrombus, or explant for HVAD-supported patients. Quarterly report monitoring is ongoing. [ABSTRACT FROM AUTHOR]

Biventricular heart failure remains a clinically challenging condition to manage. Available literature describing the use of durable biventricular assist device (BiVAD) support has numerous limitations hindering the development of useful treatment algorithms. Analysis of BiVAD use within a large multicenter data set is needed to clarify outcomes associated with this therapy. The Society of Thoracic Surgeons Intermacs database was queried to identify adults aged ≥18 years who received durable circulatory support from January 1, 2010, to December 31, 2220. The data set was divided into the following cohorts: (1) left ventricular assist device (LVAD) only (n = 27,325), (2) LVAD and concurrent right ventricular assist device (RVAD) (n = 1090), and (3) LVAD and sequential RVAD (n = 556). Propensity score matching was used to compare 1-year mortality and adverse events between concurrent (n = 565) and sequential BiVADs (n = 565). Overall survival within 1 year was significantly worse for the BiVAD cohort compared with the LVAD-only cohort (12-month survival: 50.8% vs 82.6%; log-rank P <.001). In a propensity-matched cohort, patients implanted with a BiVAD concurrently had an improved survival compared with those implanted an LVAD and an RVAD sequentially (12-month survival: 55.8% vs 41.8%; log-rank P <.001). Early (<3 months) adverse event rates were higher among patients receiving sequential BiVADs for bleeding, infection, neurologic dysfunction, and renal dysfunction (P <.01). After matching for patient and disease characteristics, patients with sequential BiVAD implantation have worse outcomes than patients with concurrent BiVAD implantation. [Display omitted] [ABSTRACT FROM AUTHOR]

Continuous flow left ventricular assist devices have improved outcomes in patients with end-stage heart failure that require mechanical circulatory support. Current devices have an adverse event profile that has hindered widespread application. The EVAHEART®2 left ventricular assist device (EVA2) has design features such as large blood gaps, lower pump speeds and an inflow cannula that does not protrude into the left ventricle that may mitigate the adverse events currently seen with other continuous flow devices. A prospective, multi-center randomized non-inferiority study, COMPETENCE Trial, is underway to assess non-inferiority of the EVA2 to the HeartMate 3 LVAS when used for the treatment of refractory advanced heart failure. The primary end-point is a composite of the individual primary outcomes: Survival to cardiac transplant or device explant for recovery; Free from disabling stroke; Free from severe Right Heart Failure after implantation of original device. Randomization is in a 2:1 (EVA2:HM3) ratio. The first patient was enrolled into the COMPETENCE Trial in December of 2020, and 25 subjects (16 EVA2 and 9 HM3) are currently enrolled. Enrollment of a safety cohort is projected to be completed by third quarter of 2022 at which time an interim analysis will be performed. Short-term cohort (92 EVA2 subjects) and long-term cohort is expected to be completed by the end of 2023 and 2024, respectively. The design features of the EVA2 such as a novel inflow cannula and large blood gaps may improve clinical outcomes but require further study. The ongoing COMPETENCE trial is designed to determine if the EVA2 is non-inferior to the HM3. [ABSTRACT FROM AUTHOR]

The HeartWare HVAD System (Medtronic) is a durable implantable left ventricular assist device that has been implanted in approximately 20,000 patients worldwide for bridge to transplant and destination therapy indications. In December 2020, Medtronic issued an Urgent Medical Device Communication informing clinicians of a critical device malfunction in which the HVAD may experience a delay or failure to restart after elective or accidental discontinuation of pump operation. Moreover, evolving retrospective comparative effectiveness studies of patients supported with the HVAD demonstrated a significantly higher risk of stroke and all-cause mortality when compared with a newer generation of a commercially available durable left ventricular assist device. Considering the totality of this new information on HVAD performance and the availability of an alternate commercially available device, Medtronic halted the sale and distribution of the HVAD System in June 2021. The decision to remove the HVAD from commercial distribution now requires the use of the HeartMate 3 left ventricular assist system (Abbott, Inc) if a patient previously implanted with an HVAD requires a pump exchange. The goal of this document is to review important differences in the design of the HVAD and HeartMate 3 that are relevant to the medical management of patients supported with these devices, and to assess the technical aspects of an HVAD-to-HeartMate 3 exchange. This document provides the best available evidence that supports best practices. [Display omitted] [ABSTRACT FROM AUTHOR]

Use of continuous-flow left ventricular assist devices (LVAD) has increased over the years as a bridge to transplant. The HeartWare HVAD (Medtronic, Minneapolis, MN) and HeartMate III (HM3, Abbott, Abbott Park, IL) are currently approved centrifugal-flow devices used for bridge to transplant. We sought to evaluate outcomes of the patients listed and who received a transplant after receiving these 2 devices. The United Network of Organ Sharing thoracic transplant database was queried after August 23, 2017, until December 2018 to identify patients aged older than 18 years listed for heart transplant and supported by the HVAD or HM3. Patient characteristics were evaluated at the time of listing and transplant. The primary study end point was 1-year mortality after LVAD implantation. Nonparametric tests were used to evaluate the device groups. Of 569 patients listed for heart transplant during the study period, 226 had HM3 and 343 had HVAD. The HM3 group had more men (82% vs 74%, P =.02), patients with diabetes (38% vs 29%, P =.02), and the body mass index was higher (28 vs 27 kg/m2, P =.04) at listing. Between the HM3 and HVAD groups, the 1-year mortality was 20% vs 17%, respectively (log-rank P =.28; Figure 1), and the posttransplant survival at 1 year was 97% and 94%, respectively (P =.1). In a relatively well-matched group of patients listed for heart transplant with a centrifugal-flow LVAD, the 6-month and 1-year mortality on the waiting list as well as after transplant were not statistically different. Additional real-world experience or a randomized trial would be needed to determine whether one LVAD is superior. [ABSTRACT FROM AUTHOR]

ABO-incompatible (ABOi) heart transplantation (HT) in infants has been used to reduce waiting list time and mortality with outcomes comparable to ABO compatible (ABOc). We sought to assess trends in ABOi listing and transplantation for infants within the United Network for Organ Sharing registry and to evaluate its influence on outcomes. We reviewed infants listed for HT in the United Network for Organ Sharing registry (2007-2018). We compared demographic and clinical characteristics, waiting list duration, graft survival, and 1-year freedom from rejection between patients listed for ABOi and ABOc. Cochran-Armitage trend test, univariate nonparametric statistical methods, and Kaplan-Meier curves were used to analyze the data. During the study period, 2787 patients were listed for HT, 53% of whom were listed for ABOi. Median waiting list time for patients in blood group O receiving an ABOi transplant was significantly shorter (P <.0001). Among the 1862 patients who received HT, 15% were ABOi. The incidence of ABOi HT also increased over time. The pretransplant anti-A and anti-B titers in the ABOi group did not significantly affect outcomes. There was no difference in the incidence of rejection in the first year after transplant and no significant difference in posttransplant survival The number of infants listed and transplanted as ABOi has gradually increased over the past decade, with a significantly decreased waiting list time for ABOi transplants in blood group O. At 1 year after transplant, rejection was comparable between the ABOi and ABOc groups and there was no significant difference in survival. [ABSTRACT FROM AUTHOR]

To compare the performance of a novel NeurOs cerebral oximetry monitor against the INVOS monitor during the entire intraoperative phase of cardiac surgery, including periods of known fluctuation in brain oxygenation, such as preoxygenation, induction, cannulation, and cardiopulmonary bypass. This study was a prospective, nonrandomized, healthcare-provider and outcome-assessor blinded study. Tertiary care university hospital; single institutional study. Twenty-three patients who underwent cardiac surgery with cardiopulmonary bypass. Both self-adhesive INVOS sensors and the assembled NeurOs sensors were placed accordingly when the patient arrived in the operating room. Ten out of 13 cases under the normal mode and eight out of the 10 cases under the high- sensitivity mode showed significant correlations between the NeurOs and INVOS groups (p < 0.05, r value from 0.24-0.88). When all cases were combined, NeurOs demonstrated significant correlation with INVOS (r = 0.5, 95% confidence interval [CI] 0.44-0.56, p < 0.01 for normal mode; r = 0.69, 95% CI 0.64 to 0.74, p < 0.01 for high-sensitivity mode) in both modes. To evaluate the data diversity, the authors performed a cluster analysis and found much less variation existed in the NeurOs normal mode when compared with INVOS (standard deviation [SD] 16.6% in INVOS, 4% in NeurOs normal mode) but similar patterns in the high-sensitivity mode (SD 17.6% in INVOS, 15.2% in NeurOs high-sensitivity mode). Bland-Altman plot analysis showed that most of the data fell between ± 1.96 SD lines, which demonstrated good consistency between these two methods under both modes of NeurOs (–28.8 to 30.8 in the normal mode; –36.6 to 32.7 in high-sensitivity mode). In the normal mode of NeurOs monitoring, receiver operating characteristic analysis suggested a 2% cutoff point was most optimal from the baseline for detecting hyperoxia (sensitivity 73%; specificity 66%) and minus 1% (sensitivity 66%; specificity 67%) for detecting hypoxia. Whereas in the high-sensitivity mode, the optimal cutoff point was 3% from baseline for detecting hyperoxia (sensitivity 75%; specificity 68%), and minus 3% for detecting hypoxia (sensitivity 90%; specificity 45%). In conclusion, the novel NeurOs system was found to correlate with INVOS cerebral oximetry measurements during cardiac surgery. [ABSTRACT FROM AUTHOR]

Transfusions are extremely frequent after cardiac surgery, and they have a considerable economic burden and impact on outcomes. Optimal patient blood management could play a fundamental role in reducing the rate of transfusion and Jehovah's Witnesses (JW) represent the ideal surrogate study population. This meta-analysis compares outcomes of JWs and non-JWs' patients undergoing cardiac surgery, assessing the safety of a bloodless cardiac surgery. A scoping review was conducted using a search strategy for studies assessing outcomes of JW undergoing cardiac surgery. The primary outcome was perioperative mortality, and a random-effects meta-analysis was performed. Ten studies were included in our meta-analysis, involving 780 JW patients refusing any type of transfusion ("JW") and 1182 patients accepting transfusion if needed ("non-JW"). 86% of non-JW patients received at least 1 transfusion. There was no significant difference in terms of perioperative mortality (OR 0.91; 95% CI 0.55-1.52; p = 0.72). The volume blood loss was significantly less in the JW (p = 0.001), while the rate of reoperation for bleeding was also lower, but not statistically significative, in the JW (p = 0.16). Both preoperative and postoperative hemoglobin and hematocrit were significantly higher in the JW. Therefore, we concluded that bloodless cardiac surgery is safe and early outcomes are similar between JW and non-JW patients: optimal patient blood management is fundamental in guarantying these results. Further studies are needed to assess if a limitation of transfusion could have a positive long-term impact on outcomes. [ABSTRACT FROM AUTHOR]

Objectives: In patients with reduced kidney function there are no established guidelines to suggest combined heart-kidney transplant (HKTx) versus sequential kidney transplant (SKTx) using preoperative value of estimated glomerular filtration (eGFR).Methods: The United Network for Organ Sharing database was queried from 2000 to 2015 to evaluate survival of HKTx and SKTx population stratified by preoperative eGFR rate <45 mL/min. Aim of the study was to assess the eGFR rate that is most beneficial to perform a concomitant or a SKTx at time of transplant evaluation.Results: In our analysis, patients who required SKTx are recipients that, after heart transplantation, developed or worsened kidney insufficiency due to calcineurin inhibitor nephrotoxicity. In recipients with eGFR <30 or dialysis, a total of 545 received HKTx and 80 received SKTx. The median waiting time between heart and kidney transplant in SKTx group was 6 years. The overall post-transplant survival was 81% and 80% and 75% and 59% at 5 and 1 years for the HKTx and SKTx groups, respectively (P = .04). In recipients with eGFR from 30 to 44, a total of 107 received HKTx and 112 received SKTx. The median waiting time between heart and kidney transplant in SKTx group was 4 years. Overall post-transplant survival showed no statistically significant differences in HKTx group (n=107) compared with SKTx group (n=112) and was 90% and 95% at 1 year and 74% and 52% at 5 years, respectively (P = .4) .Conclusions: To optimize organ and patient survival, eGFR value can be utilized to discern between HKTx versus SKTx in patients with decreased renal function at the time of heart transplantation. Patients with eGFR<30 or in dialysis presented better survival with HKTx, while both SKTx and HKTx are suitable for patients with eGFR between 30 and 45. [ABSTRACT FROM AUTHOR]

Objectives: Wide QRS duration and ventricular pacing are common in recipients of continuous-flow left ventricular assist devices (CF-LVADs) but their impact on outcomes remains unclear. We assessed the clinical and arrhythmic outcomes of CF-LVAD patients with wide QRS or right ventricular (RV) pacing at baseline, compared with those with narrow QRS and those with continued cardiac resynchronization therapy (CRT).Methods and Results: A total of 520 patients (57 ± 13 years) with an implantable cardioverter-defibrillator (ICD) (n = 240) or CRT-defibrillator (n = 280) who underwent CF-LVAD implantation at 5 centers in 2007-2015 were studied. Patients were divided into 3 groups: ICD-N (QRS ≤120 ms; n = 134), ICD-W (QRS >120 ms; n = 106), and CRT (n = 280). Mortality, hospitalization, and ventricular arrhythmia (VA) incidence were compared among the groups. Baseline QRS duration was different among the groups (100 ± 13 [ICD-N] vs 155 ± 26 [ICD-W] vs 159 ± 29 ms [CRT]; P < .0001). In the ICD-W group, 37 (35%) had >80% RV pacing at baseline. Median biventricular pacing in the CRT group was 96%. Over 523 days of CF-LVAD support, Kaplan-Meier analysis showed no difference in survival among groups (log rank P = .9). According to multivariate Cox regression, wide QRS duration and RV pacing were not associated with survival. QRS narrowed during CF-LVAD support in the ICD-W and CRT groups but was not associated with improved survival (P = .9). No differences were noted among the groups in hospitalizations (P = .9), VA (P = .2), or ICD shocks (P = .06).Conclusions: In this large CF-LVAD cohort, a wide QRS duration, high percentage of RV pacing at baseline, and changes in QRS duration after LVAD implantation were not associated with survival. Continued CRT after CF-LVAD implantation also was not associated with improved survival or HF hospitalizations. [ABSTRACT FROM AUTHOR]

Neointimal hyperplasia and lumen irregularities are major contributors to vein graft failure and the use of VEST(R) should prevent this. In this review, we aim to evaluate the angiographic outcomes of externally supported vein grafts. Medline, Embase and Cochrane Library were systematically reviewed for randomized clinical trials published by August 2022. The primary outcome was graft failure. Secondary outcomes included graft ectasia, intimal hyperplasia area and thickness, and graft nonuniformity. Odds ratios (OR) for dichotomous variables and mean difference (MD) for continuous variables with 95% confidence intervals (CI) were pooled using a fixed-effects model. Three randomized controlled trials with a total of 437 patients were included with follow-up ranging from 1 to 2 years. The odds of graft failure were similar in the 2 groups (OR 1.22; 95%CI 0.88-1.71; I² = 0%). Intimal hyperplasia area [MD -0.77 mm2; 95%CI -1.10 to -0.45; I2 = 0%] and thickness [MD -0.06 mm; 95% CI -0.08 to -0.04; I2=0%] were significantly lower in the VEST group. Fitzgibbon Patency Scale of II or III (representing angiographic conduit nonuniformity; OR 0.67; 95%CI 0.48-0.94; I2 = 0%) and graft ectasia (OR 0.53; 95%CI 0.32-0.88; I2 = 33%) were also significantly lower in the VEST group. At short-term follow-up, VEST does not seem to reduce the incidence of graft failure, although it is associated with attenuation of intimal hyperplasia and nonuniformity. Longer angiographic follow-up is warranted to determine whether these positive effects might translate into a positive effect in graft failure and in long-term clinical outcomes. [Display omitted] [ABSTRACT FROM AUTHOR]

Background Optimal surgical treatment of infective tricuspid endocarditis is debatable, especially in the setting of inherent social and pathologic concerns. This study compared tricuspid valve repair, replacement, and excision for the treatment of infective endocarditis Methods A single-center cardiac surgery database was queried to identify patients aged older than 18 years who underwent tricuspid valve operations for infective endocarditis between 2012 and 2016. Patients were divided into three groups by the type of tricuspid valve operation: valvectomy, repair, or replacement. Patients were evaluated to identify differences between preoperative factors and outcomes, including death, length of stay, and complications. Results During the study period, 63 patients underwent surgical treatment of infective tricuspid valve endocarditis. Demographic and baseline characteristics were comparable across all groups, except that the valve repair group was older compared with valvectomy and replacement (46 vs 29 and 31 years, respectively; p = 0.007), with more hypertension, elevated creatinine, and a lower incidence of diffuse, bilateral pulmonary emboli. Staphylococcus species were the most common organisms. The incidence of death, bleeding requiring reoperation, major stroke, prolonged ventilator time, intensive care unit stay, and overall hospital length of stay were similar in all groups. Of patients undergoing initial valvectomy, 36% were available for follow-up at 1 year, highlighting the challenges associated with the intravenous drug abuse cohort. Patients who underwent tricuspid valvectomy in the group available for follow-up had significantly lower unplanned readmission rates at 1 year. Conclusions Tricuspid valve endocarditis patients who undergo tricuspid valve excision, repair, and replacement have similar 30-day operative mortality, as defined by The Society of Thoracic Surgeons. Excision patients have significantly lower unplanned readmission rates at 1 year. Tricuspid valvectomy is an acceptable initial treatment in this high-risk group as part of a surgical strategy to identify patients who are candidates for eventual valve replacement. Further study of long-term outcomes and survival is warranted. [ABSTRACT FROM AUTHOR]

Objective Left ventricular assist device (LVAD) surgery is complex, high risk, and expensive. The authors’ hypothesis is baseline regional cerebral oxygen saturation (rSO 2 ) might be a predictor of postoperative clinical outcomes. Design Retrospective review of 210 consecutive continuous flow LVAD patients between 2008 and 2014. The primary measure is 30-day mortality rate and secondary measures include modified major adverse cardiocerebral events (MACE), length of stay (LOS), and intensive care unit (ICU) stay. Multiple logistic regression models were applied to examine if a binary outcome variable, such as 30-day mortality and MACE, is associated with rSO 2 at baseline. Log-linear model was used to examine whether LOS or ICU stay hours is associated with rSO 2 at baseline. Setting Single institution, academic hospital. Participants Patients who received LVAD surgery ​at Jewish Hospital, Louisville, KY. Interventions All patients received LVAD surgery. Cerebral oximetry monitoring was used in both the preoperative and intraoperative periods. Measurements and Main Results The authors found that higher rSO 2 at baseline is associated with lower 30-day mortality with an odds ratio of 0.94 and 95% confidence interval (0.888, 0.995) for every 1% increase of rSO 2 . For secondary outcomes, baseline rSO 2 was not significantly associated with MACE, requirement for postoperative renal failure/dialysis, reoperation for bleeding, and LOS or ICU hours. Conclusions Regional cerebral oxygen saturation levels at baseline are significantly associated with 30-day mortality after LVAD surgeries. [ABSTRACT FROM AUTHOR]

Background Optimum use of donor organs can increase the reach of the transplantation therapy to more patients on waiting list. The heart transplantation (HTx) has remained stagnant in United States over the past decade at approximately 2,500 HTx annually. With the use of the United Network of Organ Sharing (UNOS) deceased donor database (DCD) we aimed to evaluate donor factors predicting donor heart utilization. Methods UNOS DCD was queried from 2005 to 2014 to identify total number of donors who had at least one of their organs donated. We then generated a multivariate logistic regression model using various demographic and clinical donor factors to predict donor heart use for HTx. Donor hearts not recovered due to consent or family issues or recovered for nontransplantation reasons were excluded from the analysis. Results During the study period there were 80,782 donors of which 23,606 (29%) were used for HTx, and 38,877 transplants (48%) were not used after obtaining consent because of poor organ function (37%), donor medical history (13%), and organ refused by all programs (5%). Of all, 22,791 donors with complete data were used for logistic regression (13,389 HTx, 9,402 no-HTx) which showed significant predictors of donor heart use for HTx. From this model we assigned probability of donor heart use and identified 3,070 donors with HTx-eligible unused hearts for reasons of poor organ function (28%), organ refused by all programs (15%), and recipient not located (9%). Conclusions An objective system based on donor factors can predict donor heart use for HTx and may help increase availability of hearts for transplantation from existing donor pool. [ABSTRACT FROM AUTHOR]

Background Heart transplantation remains the gold standard therapy for end-stage heart failure patients; however, volumes are limited because of donor organ shortage. With the increasing availability of more durable continuous flow left ventricular assist devices (CFLVADs), the matrix of the heart transplantation waiting list and that of donor allocation have seen substantial changes. We aimed to evaluate the impact of the stated reasons for status 1A at time of transplantation on post-transplantation survival in CFVAD patients. Methods The United Network of Organ Sharing (UNOS) thoracic organ transplantation database was queried between 2006 and 2013 to identify patients aged 18 years or older who underwent heart transplantation as UNOS status 1A. We further assessed the data to identify reasons for status 1A at time of transplantation in CFVAD patients. We also computed post-transplantation survival of patients supported with CFLVAD who were status 1A at the time of transplantation. Results A total of 15,779 patients underwent heart transplantation during the study time period, of whom 8,429 were Status 1A, and 3,913 had CFLVAD at time of transplantation. Of all status 1A patients, 2,737 had CFLVAD at time of transplantation, of which 52% (1,413) had device complications (thrombosis, infection, malfunction, and other) and 48% (1,314) were on 30-day grace status 1A. Post-transplantation survival (at 3 years) of CFLVAD patients who received a transplant on 30-day grace status 1A was similar to patients who underwent transplantation on status 1B (84% versus 85%, p = 0.5), both of which were significantly better than status 1A patients because of device complications (84% and 85% versus 78%, p = 0.01) ( Fig 1 ). Conclusions CFLVAD patients who underwent transplantation as Status 1B or on the 30-day grace Status 1A have similar post-transplantation survival. These data suggest that there needs to be an objective organ allocation system for recipients of heart transplant that prioritize patients with CFVAD complications and patients not eligible for CFVAD for transplantation over 30-day grace period patients. [ABSTRACT FROM AUTHOR]

Background Donor heart availability has limited the number of heart transplants performed in the United States, while the number of patients waiting for a transplant continues to increase. Optimizing the use of all available donor hearts is important to reduce waiting list deaths and to increase the number of patients who can ultimately undergo a successful heart transplant. Donor cardiopulmonary resuscitation (CPR) time has been proposed to be a selection criterion to consider in donor selection. This study examined whether the duration of donor CPR time affects recipient posttransplantation outcomes and survival. Methods The United Network of Organ Sharing database was retrospectively queried from January 2005 to December 2013 to identify adult patients who underwent heart transplantation. This population was divided into four groups: donors with no CPR, CPR of less than 20 minutes, CPR of 20 to 30 minutes, and CPR exceeding 30 minutes. Kaplan-Meier analysis was used to compare the recipient posttransplant survival between groups, and posttransplant outcomes were examined. Propensity matching was performed for comparison of posttransplant survival of recipients of donors who did and did not undergo CPR. Multivariable logistic regression analysis was performed to examine individual independent variables for death after transplant. Results During this period, 17,022 patients underwent heart transplantation. Of those, 16,042 patients received hearts from a donor with no CPR, 639 patients with donor CPR of less than 20 minutes, 154 patients with donor CPR 20 to 30 minutes, and 187 patients with donor CPR exceeding 30 minutes. The posttransplant survival at 1 year for each group was 89% vs 90% vs 88% vs 89% and at 5 years was 75% vs 74% vs 74% vs 72%, respectively, which was not significantly different among the groups. Recipient primary graft failure and rejection rates were similar among the groups. The multivariable regression model showed CPR duration was not an independent risk factor for posttransplant death. Conclusions Donor CPR does not significantly affect outcomes and survival after transplant. In an effort to optimize donor heart use, donor CPR time alone should not be used to rule out the acceptance of a potential donor heart. [ABSTRACT FROM AUTHOR]

Background The shortage of donor hearts has limited cardiac transplantation for end-stage heart failure, leading to the increased use of left ventricular assist devices (LVADs) as bridge-to-transplant (BTT) and marginal donor hearts; however, outcomes have been mixed. This study examines differences in wait list survival of patients with continuous flow LVADs and post-transplantation survival of patients receiving a marginal donor heart. Methods The United Network of Organ Sharing database was retrospectively queried from January 2005 to June 2013 to identify adult patients listed for heart transplant. Marginal donor criteria included age greater than 55 years, hepatitis C positive, cocaine use, ejection fraction less than 0.45, or donor to recipient body mass index mismatch of greater than 20%. The primary endpoint was wait list survival of patients with LVADs compared with post-transplant survival of marginal donor heart recipients using Kaplan-Meier analysis. Results A total of 2,561 and 4,737 patients received LVAD support or a marginal donor heart, respectively. The 30-day, 1-year, and 2-year survival was 96%, 89%, and 85%, for patients with LVAD support on the waiting list and 97%, 89%, and 85%, respectively, for recipients of marginal donor hearts ( p = 0.213). Recipients of marginal hearts had worse survival than non-marginal heart recipients at 3 years ( p = 0.011). Conclusions There was no significant difference between waiting list survival of patients with LVAD support as BTT and post-transplant survival of recipients with marginal donor hearts. There could be clinical benefits for using LVAD support as BTT to allow time for better allocation of optimal donor hearts as opposed to transplantation with a marginal donor heart. [ABSTRACT FROM AUTHOR]

Background Ex vivo lung perfusion (EVLP) has the potential to increase the donor pool for lung transplantation by facilitating resuscitation and extended evaluation of marginal organs. Current EVLP methodology employs continuous flow (CF) pumps that produce non-pulsatile EVLP hemodynamics. In this feasibility study, we tested the hypothesis that a pulsatile flow (PF) pump will provide better EVLP support than a CF pump through delivery of physiologic hemodynamics. Methods Porcine lungs were supported in an EVLP model by centrifugal CF (n = 3) or PF (n = 4) left ventricular assist devices. Lungs were ventilated at 4 to 5 mL/kg, 0.21 fraction of inspired oxygen (FiO 2 ), and perfused with an acellular, albumin-based solution corrected for osmolarity, acid-base balance, and carbon dioxide pressure (≤20 hours at 30 ° C) for a minimum of 12 hours support. Prostaglandin E 1 and 30% albumin were infused continuously. Hemodynamic, respiratory, and blood gas parameters were continuously monitored and digitally recorded hourly. Parenchymal biopsies were used for quantification of wet to dry weight ratio. Results All lungs maintained function in the EVLP circuit for a minimum of 12 hours (mean 14.7 ± 1 hours) and demonstrated minimal edema formation. The PF EVLP produced higher pulsatility as demonstrated by greater energy equivalent pressure and surplus hemodynamic energy compared with CF EVLP ( p < 0.05). There were no statistically significant differences in pulmonary impedance, arterial partial pressure of oxygen/fraction of inspired oxygen, wet to dry weight ratio, and peak airway pressure between CF and PF EVLP. Conclusions The CF and PF EVLP systems successfully maintained lungs 12+ hours using a modified Steen perfusate (XVIVO Perfusion, Inc, Goteborg, Sweden); however, there were no statistically significant differences between CF and PF groups despite higher pulsatility, suggesting that PF may not offer immediate benefits over CF for prolonged ex vivo lung preservation. [ABSTRACT FROM AUTHOR]

Background Preoperative aspirin use within 5 days of cardiac operations is controversial. Aspirin could reduce cardiovascular complications and yet might increase risk of bleeding. Recent reports showed conflicting results, and whether aspirin has variable effects for different cardiac surgical procedures is unclear. Methods A single-center retrospective cohort analysis was performed. After propensity score matching (PSM) for identified confounders, the relationship between preoperative aspirin use and 30-day all-cause mortality, postoperative renal failure, major adverse cardiocerebral events (MACE), blood transfusion, reoperation for bleeding, and postoperative infection were estimated with separate logistic regression models. Results Preoperative aspirin therapy was associated with a 49% ( p = 0.04) increased risk of reoperation for bleeding among 868 matched pairs of patients undergoing valve operations. Among 725 matched patients undergoing coronary artery bypass grafting (CABG), preoperative aspirin therapy was not associated with a statistically significant higher risk of reoperation for bleeding. However, preoperative aspirin use, compared with nonuse, was not associated with risks of MACE, 30-day mortality, postoperative renal failure, blood transfusion, or postoperative infection in the entire cohort, in patients undergoing valve operations only, and in patients undergoing CABG only after PSM. Conclusions Preoperative aspirin use in all patients undergoing cardiac operations was not associated with risks of major cardiac, cerebral, or renal complications and infections and death; however, the risk of reoperation for bleeding was elevated among preoperative aspirin users compared with nonusers in a subpopulation of patients undergoing valve operations only. [ABSTRACT FROM AUTHOR]

Background Implantable cardioverter-defibrillators (ICDs) can improve survival in left ventricular assist device (LVAD) recipients. However, the impact of cardiac resynchronization therapy (CRT-D) on outcomes in continuous-flow left ventricular assist device (CF-LVAD) patients is not known. We sought to determine if CRT-D improved clinical outcomes in CF-LVAD patients compared with ICDs alone. Methods and Results Sixty-one consecutive CF-LVAD patients with an ICD or CRT-D were evaluated. Impacts of CRT-D on mortality, all-cause hospitalization, and incidence of atrial (AA) and ventricular (VA) arrhythmias after LVAD implantation was compared with patients with ICD alone. Of the 61 LVAD patients, 31 (age 59.8 ± 16 years, 84% male) had CRT-D and 30 (age 57.2 ± 13 years, 74% male) had ICD. Before LVAD implantation, no significant differences were noted between the groups in demographic and clinical characteristics, LVAD indications, and incidence of AA and VA. Over 682 ± 45 days of LVAD support, 8 patients (25.8%) died in the CRT-D arm versus 5 (16.7%) in the ICD arm ( P = .35). No differences were noted between the CRT-D and ICD groups in all-cause (96.8 vs 93.3%; P = .63) and HF (19.4 vs 26.7%; P = .78) hospitalizations, left ventricular (LV) end-diastolic diameter (6.4 ± 1.5 vs 6.2 ± 1.1 cm, P = .47), and incidence of AA (35.4% vs 33.3%; P = .80), VA (29% vs 26.6%; P = .86), and ICD shocks (22.6% vs 16.7%; P = .93). Beta-blocker and antiarrhythmic drug use after LVAD implantation was similar in both groups. Conclusions In patients with refractory HF who received CF-LVADs, CRT-D, compared with ICD, did not significantly improve mortality, all-cause hospitalization, LV dimensions, and incidence of AA and VA. [ABSTRACT FROM AUTHOR]

Although significant cardiac structural and functional improvement is a prerequisite for an LVAD-supported patient to be considered for device weaning, multiple factors including patient willingness, physician expertise, and center experience, weigh in on this complex decision. Existing predictive models defining cardiac recovery as device removal might underestimate the reverse remodeling rates. To develop a predictive tool to identify patients prone to improve cardiac structure and function, independent of the complex decision to deactivate a durable, surgically deployed device. Advanced chronic HF patients (N=703) requiring continuous-flow LVADs were evaluated. After excluding patients with acute HF etiologies and/or inadequate post-LVAD follow-up (<3 months), 3 US programs contributed 390 patients (derivation cohort), while 5 US programs formed the validation cohort (n=245). We defined responders as patients with an LVEF ≥40% and LVEDD ≤6.0 cm within the first year of LVAD support. Multivariable logistic regression on the derivation set yielded a predictive model, which was externally tested; a predictive score was developed. Overall, 18.5% of the patients were responders. Compared to the validation, patients in the derivation cohort were more likely white (83 vs 69%; p<0.001), with ischemic HF (42 vs 33%; p=0.04), and longer HF duration (88 vs 66 months; p<0.001). Multivariable predictors of responders and the derived scoring system are shown in the Figure (c-statistic 0.74 [95% CI: 0.66-0.83] and 0.71 [95% CI: 0.59-0.77] in the derivation and validation set). Focused on patients experiencing significant reverse remodeling post-LVAD support we developed a predictive score achieving good discriminative performance in distinct, heterogeneous, contemporary cohorts. This tool can be useful in selecting patients to implement diagnostic and therapeutic protocols to promote reverse remodeling and myocardial recovery. [ABSTRACT FROM AUTHOR]

Background Continued donor organ shortage and improved outcomes with current left ventricular assist device (LVAD) technology have increased the number of patients supported with bridge-to-transplantation (BTT) therapy. Using the United Network of Organ Sharing (UNOS) database, we assessed the impact on survival in patients supported with BTT while on the heart transplant waiting list. Methods The UNOS database was queried from January 2005 to June 2012 to identify patients listed for heart transplantation as UNOS status 1A or 1B. Patients implanted with a pulsatile-flow device or an LVAD other than the HeartMate II (HM II; Thoratec Inc, Pleasanton, CA) were excluded. Patients were divided into LVAD and non-LVAD groups based on status at the time of listing. Patients were propensity matched (LVAD –non-LVAD = 1:2) for age, sex, weight, presence of diabetes, creatinine levels, mean pulmonary artery pressure, and UNOS status. Kaplan-Meier curves were analyzed for survival. Results A total of 8,688 patients were analyzed, with 1,504 (17%) in the LVAD group. Average age (52.6 ± 11.8 versus 51.3 ± 12.9 years; p = 0.0002) and weight (86.6 ± 18.6 versus 80.8 ± 18.2 kg; p < 0.0001) at time of listing were higher in the LVAD group. There were more men (79% versus 74%; p < 0.0001) and more patients with diabetes (30% versus 27%; p = 0.03) in the LVAD group. Of all patients, 6,943 patients (80%) underwent transplantation, 862 (10%) died, and 883 (10%) remained on the waiting list. After propensity matching, survival to transplantation was significantly better in the LVAD group than in the non-LVAD group at both 1 year (91% versus 77%) and 2 years (85% versus 68%). Conclusions Patients supported with an HM II LVAD as BTT therapy were older with increased comorbidities; they demonstrated an improved survival while listed for heart transplantation. The use of LVADs as a BTT strategy can potentially improve patient survival while waiting for transplantation and allow better allocation of donor hearts. [ABSTRACT FROM AUTHOR]

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. [Copyright &y& Elsevier]

Background: Small series have identified a relationship between preoperative hematocrit (HCT) and outcomes in coronary artery bypass graft (CABG) surgery. The Society of Thoracic Surgeons (STS) Adult Cardiac Surgery Database (ACSD) began collecting preoperative HCT data in 2008. In this study, analyses were performed to determine the impact of preoperative HCT on perioperative morbidity and mortality among patients undergoing isolated CABG. Methods: Data were collected on 182,599 patients who underwent primary isolated on-pump CABG between 2008 and 2009 and were included in the STS ACSD. Data were included only from centers that performed more than 100 on-pump cases per year during the period of study. Dialysis patients as well as those with previous cardiovascular operations or missing data for HCT were excluded. We then performed multivariable analysis using the 2008 STS CABG risk model as a guide, including HCT as a predictor. Logistic regression was performed for operative mortality and other adverse outcomes. Results: Overall operative mortality was 1.6% (3,005 of 182,599). Compared with patients with anemia (HCT <33%), patients with HCT of at least 42% had lower mortality (1.1% versus 3.4%; p < 0.0001) and lower rates of renal failure (2.0% versus 7.8%; p < 0.0001), stroke (0.9% versus 1.8%; p < 0.0001), prolonged ventilation (8.4% versus 17.5%; p < 0.0001), and deep sternal wound infection (0.3% versus 0.6%; p < 0.0001). In adjusted analyses, each 5-point decrease in preoperative HCT was associated with an 8% higher odds of death (odds ratio, 1.08; p = 0.0003), a 22% increase in the odds of postoperative renal failure (odds ratio, 1.22; p < 0.0001), and a 10% increase in the risk of deep sternal wound infection (odds ratio, 1.10; p < 0.01). Similar results were observed among patients (n = 74,292) undergoing elective CABG. The percentage of patients receiving perioperative blood transfusion decreased from 88.5% in the anemic group (HCT <33%) to 32.5% in patients with HCT of at least 42% (p < 0.0001). Conclusions: Preoperative HCT is a powerful independent predictor of perioperative mortality as well as renal failure and deep sternal wound infection in patients undergoing isolated primary CABG operations. These findings should prompt investigation of strategies to increase preoperative HCT. [Copyright &y& Elsevier]

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. [ABSTRACT FROM AUTHOR]

Background. The purpose of this study was to evaluate outcomes of patients with low ejection fraction who underwent surgical coronary revascularization with or without cardiopulmonary bypass (CPB). Methods. The Society of Thoracic Surgeons National Database was queried from January 1, 2008, to June 30, 2011 for patients with an ejection fraction of less than 0.30 who underwent primary, nonemergent coronary artery bypass (CAB) grafting. The entire cohort of 25,667 patients was divided into those who underwent revascularization with (ONCAB, n = 20,509) and without (OPCAB, n = 5,158) CPB. OPCAB patients who were converted to CPB intraoperatively were counted as intended OPCAB and were included in the OPCAB group. Propensity scores were estimated using 32 covariates, and multivariate logistic regression was used to compare risk-adjusted outcomes between groups. Results. Patients undergoing planned OPCAB were older, more frequently female, and had a lower body mass index than those who underwent ONCAB. The OPCAB cohort also had higher rates of prior stroke, peripheral vascular disease, and chronic lung disease. The predicted mortality risk was 2.3% for the OPCAB cohort vs 2.1% for the ONCAB group (p < 0.0001). Of the 5,158 patients who underwent OPCAB, unplanned conversion to CPB occurred in 270 (5.2%). OPCAB was associated with significantly lower adjusted risk of death (odds ratio [OR], 0.82), stroke (OR, 0.67), major adverse cardiac events (OR, 0.75), and prolonged intubation (OR, 0.78). Postoperative transfusion rates were significantly lower in the OPCAB group (44.8% vs 51.6%, p < 0.001). There were no adverse outcomes that occurred more commonly in OPCAB patients. The advantage associated with OPCAB was found in the entire Society of Thoracic Surgeons National Database and among high-volume and low-volume OPCAB centers. Conclusions. In The Society of Thoracic Surgeons National Database, OPCAB is associated with significantly reduced adjusted risk of early morbidity and mortality for patients having coronary bypass grafting with an ejection fraction of less than 0.30. [ABSTRACT FROM AUTHOR]

Background: Although continuous-flow left ventricular assist devices (LVAD) are durable and reliable, device replacement will be inevitable in some patients. We evaluated the incidence and outcomes of pump replacement procedures with the HeartMate II (Thoratec Corporation, Pleasanton, CA) LVAD. Methods: Data were obtained from 1,128 patients implanted from March 2005 to January 2010 with the HeartMate II during the clinical trials for bridge to transplant and destination therapy. The operative mortality associated with the replacement procedure was determined. Results: The mean duration of HeartMate II support was 568 ± 535 days (cumulative duration: 1,755 patient-years, longest: 6.5 years). A total of 72 (6.4%) patients underwent 79 LVAD replacements (0.045 events/patient-year) of which 2 were in the initial operation and 77 in separate procedures. Reasons for replacement were percutaneous lead damage (36 events, 3.0%), device thrombosis (25 events, 2.1%), infection (7 events, 0.6%), and miscellaneous other (11 events, 0.9%). The median time to pump replacement was 428 days (range 0 to 1,474). Of the 77 replacement procedures, there were 5 (6.5%) operative deaths within 30 days. The causes of death were device thrombosis, right heart failure, multisystem organ failure, and bleeding. One year after exchange (median 2.1 years after initial implant), 30% had died, 5% were transplanted, and 65% were ongoing and alive. Conclusions: HeartMate II device failure requiring pump replacement is infrequent, but when required can be done safely. These data continue to provide encouraging evidence supporting HeartMate II use for long-term circulatory support. [ABSTRACT FROM AUTHOR]

The incorporation of complex medical device technologies into clinical practice is governed by critical oversight of the US Food and Drug Administration. This regulatory process requires a judicious balance between assuring safety and efficacy, while providing efficient review to facilitate access to innovative therapies. Recent contrasting views of the regulatory process have emphasized the difficulties in obtaining an optimal balance. Mechanical circulatory support has evolved to become an important therapy for patients who have advanced heart failure with the advent of more durable, implantable ventricular assist devices. The regulatory oversight of these new technologies has been difficult owing to the complexities of these devices, associated adverse event profile, and severity of illness of the intended patient population. Maintaining a regulatory environment to foster efficient introduction of safe and effective technologies is critical to the success of ventricular assist device therapy and the health of patients with advanced heart failure. Physicians representing key surgical and cardiology societies, and representatives from the Food and Drug Administration, National Heart Lung, and Blood Institute, Centers for Medicare and Medicaid Services, Interagency Registry of Mechanically Assisted Circulatory Support, and industry partners gathered to discuss relevant issues regarding the current regulatory environment assessing ventricular assist devices. The goal of the meeting was to explore innovative ways to foster the introduction of technologically advanced, safe, and effective ventricular assist devices. The following summary reflects opinions and conclusions endorsed by The Society of Thoracic Surgeons, American Association for Thoracic Surgery, American Heart Association, Heart Failure Society of America, International Society for Heart and Lung Transplantation, and Interagency Registry of Mechanically Assisted Circulatory Support. [ABSTRACT FROM AUTHOR]

Purpose: This Food and Drug Administration–approved investigational device exempt trial assessed the safety and efficacy of a novel device for external left atrial appendage (LAA) exclusion. Description: Delivery tool and implant consisting of connectors imbedded in a compliant, soft silicone applied to the base of the LAA flush with the external wall was assessed. Evaluation: Patients in this prospective, multicenter trial were undergoing elective, nonendoscopic cardiac operations. A core laboratory independently assessed all intraprocedural and 90-day transesophageal echocardiograms. Sixty patients (37 men), aged 33 to 86 years, enrolled. The mean LAA application time was 27 seconds. Transesophageal echocardiograms at 90 days were available in 54 patients, and no leaks were detected. The residual LAA cavity exceeded 6 mm in 5 patients. One delivery device failed to close, and an adjunctive suture was required to complete LAA exclusion. One patient required adjunct sutures at a small tear site related to manual manipulation after fastener application. Conclusions: The study demonstrated safety and efficacy of this LAA exclusion device, offering an alternative to manual suturing or staples with or without reinforcement. [ABSTRACT FROM AUTHOR]

Introduction: Platelet adhesion and activation are a significant source of clinical complications. Preventing foreign surface–platelet interaction may improve biocompatibility of implantable medical devices. This study evaluated efficacy of novel technique for electrically modifying surface of conductive biomaterial and attaching blood components to prevent thrombogenesis. Specifically, this new surface modification technology, Forcefield (ATS Medical, Inc, Minneapolis, Minn), was designed to prevent platelet adhesion on pyrolytic carbon. A modulated low-voltage current is directly applied to pyrolytic carbon surfaces to stimulate adherence of a layer of charged proteins from circulating blood components that is resistive to platelet deposition. Methods: Feasibility of Forcefield technology was tested in line with cardiopulmonary bypass circuit in patients undergoing standard cardiac surgery (n = 6). Forcefield treatment was applied to segment of pyrolytic carbon with 15 minutes (n = 3) and 30 minutes (n = 3) of electrically stimulated exposure time, and resulting segments were compared with untreated pyrolytic carbon segment. Platelet adhesion confluence was then quantified by scanning electron microscopy. Results: Confluence of the Forcefield-treated pyrolytic carbon segments (3.3% ± 2.2%) was significantly reduced relative to untreated pyrolytic carbon control segments (81.7% ± 24%, P < .001). There were no discernible differences in cell confluence with Forcefield-treated segments as function of exposure time (15 or 30 minutes). Conclusions: Forcefield technology may enable modification of pyrolytic carbon surfaces to prevent platelet adhesion and thrombogenesis of implanted medical devices, including heart valves, stents, catheters, and ventricular assist devices, and may eliminate the need for anticoagulant and antiplatelet therapies. [Copyright &y& Elsevier]

Background: Left ventricular assist devices are increasingly used to treat patients with advanced and otherwise refractory heart failure as bridge to transplant or destination therapy. We evaluated a new miniaturized left ventricular assist device that requires minimal surgery for implantation, potentially allowing implantation in earlier stage heart failure. Methods: HeartWare (Miami Lakes, Fla) developed transapical miniaturized ventricular assist device. Acute (n = 4), 1-week (n = 2), and 30-day (n = 4) bovine model experiments evaluated hemodynamic efficacy and biocompatibility of the device, which was implanted through small left thoracotomy with single insertion at apex of left ventricle without cardiopulmonary bypass. The device outflow cannula was positioned across the aortic valve. The international normalized ratio was maintained between 2.0 and 2.5 with warfarin. Hemodynamic, echocardiographic, fluoroscopic, hematologic, and blood chemistry measurements were evaluated. Results: The device was successfully implanted through the left ventricular apex in all 10 animals. The device was operated at 15,000 ± 1000 rpm (power consumption, 3.5–6.0 W). The device maintained normal end-organ perfusion with no significant hemolysis (0–30 mg/dL). There were no pump failures or device-related complications. At autopsy, no abnormalities were seen in endocardium, aortic valve leaflets, or aortic root. There was no evidence of thromboembolism or abnormalities in any peripheral end organs. Conclusions: We successfully demonstrated feasibility of a novel intraventricular assist device that can be completely implanted through left ventricular apex. This transapical surgical approach eliminates needs for sternotomy, device pocket, cardiopulmonary bypass, ventricular coring, and construction of an outflow graft anastomosis. [ABSTRACT FROM AUTHOR]

Background: Patients listed for heart transplant have a prolonged wait time, with continued deterioration, poor quality of life, and 10% mortality. Although recent bridge to transplant (BTT) studies demonstrated 1-year survival similar to heart transplantation, doubt remains about overall effectiveness as a treatment strategy compared with waiting and implanting a left ventricular device (LVAD) only as a last resort. We evaluated 1-year outcome and effectiveness of LVAD vs heart transplantation. Methods: Patients on the heart transplantation list, either receiving an allograft or LVAD for BTT from January 2009 to December 2009 were evaluated. Of 43 patients treated, 1 received both LVAD and an allograft during same admission was removed from the analysis. All patients but one who received an allograft had prior LVAD. Descriptive and univariate (t test) statistics and Kaplan-Meier survival curve were used for analyses. Results: LVAD for BTT was used in 29 patients (51.4 ± 12.8 years, 6.9% women), and 13 (51.1 ± 11.6 years, 15.38% women) underwent heart transplantation. Initial hospital length of stay was 17.5 ± 14.4 days in BTT group and 14.3 ± 4.6 days in heart transplant group (p = 0.44) At 1 year, the total number of days spent in the hospital (operation and related complications), including index hospitalization was 11.6 ± 14.3 days/100 days in BTT and 7.9 ± 9.0 days/100 days in heart transplantation (p = 0.38). A total of 41% BTT and 46% heart transplant patients had one readmission within 3 months of the index hospitalization. Infection was the most common cause of readmission in both groups. The 1-year survival was similar for both groups (no hospital death in either group; 3 late deaths in the BTT group). Conclusions: One-year outcomes for patients eligible for heart transplantation were similar whether they received an allograft or LVAD for BTT. Heart transplant outcome for patients with LVAD were not adversely affected. Improving outcomes for patients treated with LVAD suggest that current decision models for patients eligible for heart transplantation may need to be reevaluated. [Copyright &y& Elsevier]

Background: Anti-coagulation with heparin is often used after left ventricular assist device implantation as a transition to long-term warfarin therapy. We retrospectively evaluated the effects of heparin use on thromboembolic and bleeding complications after implantation of the HeartMate II left ventricular assist device (LVAD). Methods: LVAD patients (n = 418) implanted as a bridge to transplant were divided into three groups: Group A patients (therapeutic, n = 118) received heparin and had a partial thromboplastin time (PTT) of >50 seconds on two or more occasions; Group B patients (sub-therapeutic, n = 178) had at least one PTT value in the range of 40 to 55 seconds; and Group C patients (no heparin, n = 122) had no PTT values >40 seconds. All patients were transitioned to warfarin and aspirin therapy. The following adverse events were evaluated: ischemic stroke; hemorrhagic stroke; pump thrombosis; bleeding requiring surgery; and bleeding requiring ≥2 units of packed red blood cells in 24 hours. Results: There was no difference in the percentages of patients with ischemic (5%, 4%, 3%) or hemorrhagic (3%, 3%, 5%) strokes or pump thrombosis (3%, 2%, 2%) after post-operative day (POD) 3 among Groups A, B and C, respectively. From PODs 3 to 30, the percentage of patients requiring transfusion for bleeding was significantly lower for Group C (18%) than for Groups A (32%) and B (26%) (p = 0.04); differences after 30 days were not significant. Multivariate analysis revealed that post-operative heparin use, low post-operative platelet count and low baseline hematocrit value were independent risk factors for bleeding events between PODs 3 and 30. Conclusions: In patients receiving the HeartMate II LVAD who were directly transitioned to warfarin and aspirin therapy without intravenous heparin there was no short-term increase in risk of thrombotic or thromboembolic events, and bleeding requiring transfusion was significantly reduced. Additional long-term follow-up is needed to evaluate possible late effects. [Copyright &y& Elsevier]

Background: Direct measurement of blood flow output has been incorporated into ventricular assist devices (VADs), but long-term reliability of the additional device components has raised concerns regarding sensor drift and failure. As an alternative approach, the HeartMate II axial VAD (Thoratec Corp, Pleasanton, CA) estimates device flow output from power consumption and rotational speed of the device motor. This study evaluated the accuracy of HeartMate II flow estimation at the time of implantation. Methods: In 20 patients, intraoperative blood flow measurement of the HeartMate II flow estimator was compared with flow values obtained with an ultrasonic flow probe placed around the device outflow graft. Estimated and measured VAD flow data were simultaneously recorded and digitally stored while the device motor speed varied from 7,800 to 11,000 rpm and while achieving device flow outputs of 2 to 7 liters/min. Estimated and measured flows were compared using linear regression analyses and root mean square error. Results: HeartMate II flow estimation (FE) demonstrated a linear correlation with ultrasonic flow probe (FP) measurements: FE = 0.74 FP + 0.99 (R 2 = 0.56, p = 0.0001). A root mean square error of 0.8 liters/min was observed between flow estimation and direct flow measurement and suggests a 15% to 20% difference at flows of 4 of 6 liters/min. Conclusions: These results suggest that HeartMate II flow estimation may be used to provide directional information for trend purposes rather than absolute values of device blood flow output. Patient management should include but not be limited to this information. [Copyright &y& Elsevier]

Background: As outcomes for destination therapy continue to improve, many patients are requiring left ventricular assist device (LVAD) exchange due to end-of-life of their LVAD. Current techniques to identify and diagnose device end-of-life issues usually require invasive testing or off-site filter dust analysis. In this study we assess a non-invasive technique using acoustic signals generated from the HeartMate XVE LVAD to potentially identify impending device end-of-life issues. Methods: Nine patients were prospectively followed after implantation of the HeartMate XVE LVAD as destination therapy between May 2004 and July 2006. Acoustic signals were collected using an aquatic hydrophone system interfaced with a data acquisition system and a standard laptop computer. Data were collected at pre-set intervals. All data/acoustic signals were prospectively interpreted by a blinded independent reviewer skilled at interpreting acoustic signals. Acoustic data suggesting possible device failure were then correlated with clinical findings and LVAD examination at the time of device removal. Results: All patients survived long enough to develop signs of impending device end-of-life. Four of 9 (44%) patients developed inflow valve incompetence, 4 (44%) were identified as having significant bearing wear, and 1 (12%) had both. All acoustically identified device issues were confirmed by standard clinical examinations and testing (echocardiography, angiography, laboratory tests and filter dust analysis). The acoustic findings were subsequently confirmed at time of device exchange. All patients ultimately had their device successfully exchanged and have continued to live with their new apparatus. Conclusions: Acoustic signal monitoring can successfully identify HeartMate XVE device end-of-life. This new method provides a low-cost, reproducible, non-invasive technique that may be used to identify possible impending device failure. [Copyright &y& Elsevier]

Objective: The Thoratec Implantable Ventricular Assist Device (Thoratec Corporation, Pleasanton, Calif) can be used for univentricular or biventricular support in patients with a body surface area as low as 1.3 m2. Results of the multicenter clinical trial are reviewed. Methods: Between October 2001 and June 2004, a total of 39 patients at 12 institutions were supported with the Thoratec Implantable Ventricular Assist Device. Twenty-four patients (62%) received left ventricular assist devices and 15 (38%) received biventricular assist devices. Indications included bridge to transplantation (n = 30) and postcardiotomy failure (n = 9). The control group included 100 patients from the Food and Drug Administration approval submissions for the paracorporeal version of the ventricular assist device. Results: Twenty-eight male and 11 female patients, with mean age of 48 years (16–71 years) and body surface area of 1.9 m2 (1.3–2.4 m2) were supported for 3938 patient-days (10.8 patient-years). Mean left ventricular assist device flow index on the first postoperative day was 2.5 ± 0.5 L/(min·m2). Mean duration of support was 101 days (9–597 days). Eighteen patients were discharged after a mean duration of 96 days. There were no ventricular assist device failures. Complications included 13 cases of bleeding requiring reexploration (33.3%), 1 embolic and 2 hemorrhagic strokes (7.7%), 5 driveline infections (12.8%), and 2 pocket infections (5%). Support to successful outcomes was 70% for bridge to transplantation and 67% for postcardiotomy recovery, versus historical results for the paracorporeal ventricular assist device of 69% for bridge to transplantation and 48% for postcardiotomy recovery. Conclusion: The Thoratec Implantable Ventricular Assist Device is a new implantable pulsatile ventricular assist device that allows hospital discharge for patients as a bridge to transplantation or for postcardiotomy failure. It is the first Food and Drug Administration–approved implantable ventricular assist device with biventricular capability. [Copyright &y& Elsevier]

Objective: We sought to investigate differences in indices of pulsatility between patients with normal ventricular function and patients with heart failure studied at the time of implantation with continuous-flow or pulsatile-flow left ventricular assist devices. Methods: Eight patients with normal ventricular function and 22 patients with heart failure were studied. A high-fidelity aortic and left ventricular pressure catheter was inserted retrograde through the aortic valve into the left ventricle, and transit-time flow probes were placed on the aorta and device outflow graft. Hemodynamic waveforms were recorded at native heart rate before cardiopulmonary bypass and over a range of device flow rates controlled by adjusting beat rate or rpm. These data were used to calculate vascular input impedance and 2 indices of vascular pulsatility: energy-equivalent pressure and surplus hemodynamic energy. Results: At low support levels, pulsatile support restored surplus hemodynamic energy to within 2.5% of normal values, whereas continuous support diminished surplus energy by more than 93%. At high support levels, pulsatile support augmented surplus energy by 49% over normal values, whereas continuous support further diminished surplus energy by 97%. Pulsatile support diminished vascular impedance from baseline failure values, whereas continuous support increased impedance. Vascular impedances at baseline for patients undergoing pulsatile and continuous support and during pulsatile support revealed normal vascular compliance, whereas impedance during continuous support indicated a loss of compliance (or “stiffening”) of the vasculature. Conclusion: These results suggest that selection of device type and flow rate can influence vascular pulsatility and input impedance, which might affect clinical outcomes. [Copyright &y& Elsevier]

Background: Minimally invasive mitral valve repair with a shortened hospital stay and quick return to an active lifestyle is the ultimate goal for robotically assisted surgery. We evaluated our da Vinci robotically assisted mitral valve repair experience toward achieving this goal.Methods: All procedures were performed with peripheral cardiopulmonary bypass, transthoracic aortic cross-clamp, and antegrade cardioplegia. Two ports and a 4-cm intercostal incision in the right chest were used for access. All patients had a ring annuloplasty, and all but 1 had a posterior leaflet resection. The entire repair and all knot tying were performed robotically.Results: Between October 2001 and October 2002, 25 patients (18 men) underwent robotic mitral valve repair. The mean age was 56 years (range, 37 to 81 years). There were no incisional conversions, deaths, strokes, or reoperations for bleeding. Twenty-one (84%) of 25 patients were extubated in the operating room. Overall mean study times were as follows: procedure, 199.7 minutes (range, 140 to 287 minutes); cardiopulmonary bypass, 126.6 minutes (range, 89 to 186 minutes); and cross-clamp, 87.7 minutes (range, 58 to 143 minutes). Eight (32%) patients were discharged home in less than 24 hours, with an average length of stay of 2.7 days. Comparing the first 10 patients to the last 15 there was a significant reduction of times: total operating room time, 318.5 versus 275.1 minutes; cross-clamp, 97.6 versus 81.1 minutes; leaflet resection or repair, 26.2 versus 15.6 minutes; annuloplasty ring, 31.9 versus 24.8 minutes; and length of stay, from 4.2 days to 1.67 days. Five patients had postoperative atrial fibrillation. Two (8%) patients ultimately required mitral valve replacement for recurrent mitral insufficiency.Conclusions: Mitral valve repair can be successfully performed with the da Vinci robotic system. Long-term follow-up is needed to determine the durability of the repair compared with a standard sternotomy approach. [Copyright &y& Elsevier]

: BackgroundParticulate emboli are thought to play a significant role in the development of cardiac surgical complications. Intraaortic filtration of particulate emboli may reduce the burden of this morbidity in cardiac patients.: MethodsA multiinstitutional randomized trial was designed and enrolled 1,289 patients at 22 centers. Six hundred forty-five patients were assigned to the treatment arm and received the Embol-X intraaortic filter, whereas 644 patients were assigned to the control arm. The endpoints examined were mortality, stroke, transient ischemic attack, renal insufficiency/failure, myocardial infarction, gastrointestinal complications, and limb-threatening ischemia. All filters were examined for histologic evidence of particulate emboli.: ResultsParticulate emboli were identified in 598 (96.8%) of 618 filters successfully deployed. Composite event rates for the clinical endpoints were similar in both the filtered and nonfiltered arm (110/645 = 17% vs 122/644 = 19%, respectively). Individual event rates were also similar in both arms. A post hoc comparison of patients with moderate or greater preoperative risk scores demonstrated event reduction favoring the filtered group for renal complications (17/124 = 14% vs 28/117 = 24%, p = 0.04) and for the composite endpoint (30/124 = 24% vs 42/117 = 36%, p = 0.047). No clinically evident complications attributed to the use of the filter were identified.: ConclusionsThe use of the Embol-X intraaortic filter is both safe and effective, as demonstrated by the emboli capture rate of 97%. In addition, post hoc analysis indicates a reduction in postoperative renal complications for patients with moderate or greater preoperative risk. Further study of high-risk patients is warranted. [Copyright &y& Elsevier]