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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.

Background: 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., Methods: 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)., Results: 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)., Conclusions: After matching for patient and disease characteristics, patients with sequential BiVAD implantation have worse outcomes than patients with concurrent BiVAD implantation., (Copyright © 2023 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

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., (Copyright © 2022 The Society of Thoracic Surgeons, The American Association for Thoracic Surgery, and European Association for Cardio-Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Background: 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., Methods: 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., Results: 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/m 2 , 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)., Conclusions: 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., (Copyright © 2022 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: 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., Methods: 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., Results: 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 CONCLUSIONS: 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., (Copyright © 2021 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

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., (Copyright © 2018 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

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., (Copyright © 2017 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

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., (Copyright © 2016 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

The obstruction of blood flow through the superior vena cava (SVC) into the right atrium may present as a severe clinical syndrome. One of the benign causes of SVC obstruction is the long-term use of indwelling catheters and wires, increasing the chances of SVC thrombosis. The treatment of the benign SVC syndrome is focused on achieving long-term durability and patency of the superior venocaval system and normal life expectancy. We report the successful surgical management of a patient with severe symptomatic SVC syndrome and emphasize technical details that might be of value in treating this challenging pathologic condition., (Copyright © 2016 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

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., (Copyright © 2016 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

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., (Copyright © 2015 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

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 (FiO2), 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 E1 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., (Copyright © 2015 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

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., (Copyright © 2014 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

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 © 2013 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

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., (Copyright © 2013 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

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., (Copyright © 2013 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

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., (Copyright © 2012 The Society of Thoracic Surgeons, American Heart Association, Inc, and International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)

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., (Copyright © 2012 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

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 © 2011 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

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.

Background: Particulate 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., Methods: A 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., Results: Particulate 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., Conclusions: The 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.

Background: Recent scientific and clinical data suggest that chronic mechanical ventricular unloading may lead to myocardial recovery. Evaluating and monitoring patients for myocardial recovery and the optimal methods of weaning the left ventricular assist device are not well defined., Methods: Six patients with advanced heart failure and severe mitral regurgitation have undergone successful bridge to recovery using a Thoratec left ventricular assist device. Data that details their monitoring for myocardial recovery and weaning from the left ventricular assist device were prospectively collected., Results: Clinical data collected during the recovery phase included chest roentgenogram, echocardiography, plasma norepinephrine, tumor necrosis factor-alpha, bioimpedance, and cardiopulmonary exercise testing (peak oxygen consumption). Normalization of these variables with a 10% increase in the peak oxygen consumption was obtained before weaning. The Thoratec device rate and percent systole were manipulated to allow gradual reloading of the ventricle. The weaning process occurred for more than 5 to 10 days to allow time for observation of the ventricle and its response to the increasing workload., Conclusions: Select patients with advanced congestive heart failure and severe mitral insufficiency can benefit from mechanical device support. We describe our technique of monitoring for myocardial recovery using clinical variables. Our technique of weaning allows for gradual reloading of the ventricle and a longer period of observation before device removal. Additional research is needed to determine which variables will accurately predict long-term myocardial recovery and the optimal weaning method.

Hypoxemia during bronchoscopy occurs frequently. It can usually be managed by supplemental oxygen and bronchodilators or, in some cases, occasionally stopping the procedure. Benzocaine spray is commonly used as a topical anesthetic agent during bronchoscopy. However, it has been associated with the development of methemoglobinemia. The following is a case report of hypoxia during bronchoscopy from benzocaine-induced methemoglobinemia and its management.

A technique is described for minimally invasive harvesting of the greater saphenous vein. This technique requires no new or disposable equipment, thus adding no additional cost to the procedure. It is rapid and reliable, and it can be performed in the majority of patients requiring greater saphenous vein for coronary artery bypass grafting.

Establishing and maintaining arterial access in pediatric cardiac operations is a frequent and sometimes frustrating problem. We have modified a procedure commonly used in our research laboratory for arterial pressure monitoring and applied it successfully to the pediatric cardiac surgical patient. The internal mammary artery can provide reliable arterial access in the postoperative period.

Wound infections after coronary artery bypass operations have been continuously monitored at the Minneapolis Veterans Affairs Hospital for 15 years. All patients were followed up for 30 days. From 1977 to 1991, 2,402 coronary artery bypass operations were performed, and wound infections developed in 125 (5%) patients. There were 71 (3%) chest infections of which 33 (1.4%) were major and 38 (1.6%) superficial. Greater than 94% of these grew only a single organism, of which 74% were Staphylococcus species. There were 63 (2.6%) leg wound infections. More than 50% of these grew multiple organisms, of which 68% were enteric in origin. Nine (0.4%) patients had simultaneous chest and leg infections. Wound infections were diagnosed an average of 15.3 +/- 6.7 (range, 4 to 30) days postoperatively, with 50% occurring after discharge from the hospital. Of 14 variables evaluated by multivariate logistic regression analysis, only steroids (p = 0.005) and diabetes (p = 0.003) were identified as independent risk factors for wound infections. Patients taking steroids or with diabetes tended to have chest infections, whereas obese patients tended to have more leg infections (p = 0.08). During an interval in the surveillance program, a trend toward increasing infections was identified and successfully reversed.