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Background Concerns regarding long-term durability of surgical repair for functional mitral regurgitation are based on short-term data, with few comparisons of ischemic (IMR) versus non-ischemic (NIFMR) etiology. Methods 788 consecutive patients receiving mitral repair for functional mitral regurgitation were evaluated from a prospectively maintained database. Patients with other surgical procedures were included. Propensity score matching was used to compare outcomes in IMR versus NIFMR. Results Unmatched IMR patients tended to be older men with greater comorbidities. 198 matched pairs of IMR versus NIFMR patients had similar demographics with relatively preserved ejection fraction 40±13% and end-systolic diameter 4.3±1.1cm. Concomitant coronary revascularization occurred in 70% of matched IMR patients. All patients received an annuloplasty ring, usually 24-26 mm. Heart failure class improved from 2.8 preop to 1.5 at 5 years (P =2+) mitral regurgitation (27±4% v 26±4%, P=0.4), severe regurgitation (10±3% v 8±2%, P=0.5), and mitral reoperation (3±1% v 3±1%, P=0.4) were not different between IMR v NIFMR. Recurrent moderate regurgitation was associated with heart failure readmission but not with mortality. Conclusions In propensity-matched patients, IMR versus NIFMR had worse survival but similar repair durability, with moderate regurgitation in 27% at 10 years and rare severe regurgitation or mitral reoperation. In selected patients with relatively preserved function, mitral repair for IMR or NIFMR can improve symptoms with durable mild regurgitation in most patients out to 10 years.

Complete revascularization (CR) at the time of coronary artery bypass graft (CABG) surgery improves long-term cardiac outcomes. No studies have previously reported angiographically confirmed CR rates post-CABG. This study's aim was to assess the impact upon long-term outcomes of CR versus incomplete revascularization (IR), confirmed by coronary angiography 1 year after CABG. Randomized On/Off Bypass Study patients who returned for protocol-specified 1-year post-CABG coronary angiograms were included. Patients with a widely patent graft supplying the major diseased artery within each diseased coronary territory were considered to have CR. Outcomes were all-cause mortality and major adverse cardiovascular events (MACE; all-cause mortality, nonfatal myocardial infarction, repeat revascularization) over the 4 years after angiography. Of the 1,276 patients, 756 (59%) had CR and 520 (41%) had IR. MACE was 13% CR versus 26% IR, p0.001. This difference was driven by fewer repeat revascularizations (5% CR vs 18% IR; p0.001). There were no differences in mortality (7.1% CR vs 8.1% IR, p = 0.13) or myocardial infarction (4% in both). Adjusted multivariable models confirmed CR was associated with reduced MACE (odds ratio 0.44, 95% confidence interval 0.33 to 0.58, p0.01), but had no impact on mortality. In conclusion, CR confirmed by post-CABG angiography was associated with improved MACE but not mortality. Repeat revascularization of patients with IR, driven by knowledge of the research angiography results, may have ameliorated potential mortality differences.

Background Failure to Rescue (FTR) is a valuable surgical quality improvement metric. The aim of this study is to assess the relationship between center volume and FTR following lung transplantation. Methods Using the database of the United Network for Organ Sharing (UNOS) all adult, primary, isolated lung recipients in the United States between May 2005 and March 2016 were identified. FTR was defined as operative mortality after any of five specific complications. FTR was compared across terciles of transplantation centers stratified based on operative volume. Results 17,185 lung recipients met study criteria. The composite FTR rate (Death following at least one complication) was 20.7%. Following stratification by volume, FTR rates increased from high to middle tercile centers (19.3% vs. 23.0%). Multivariate logistic regression models suggested an independent relationship between higher center volume and lower FTR rates (p Conclusion Higher volume lung transplantation centers have lower rates of failure to rescue.

This study sought to determine the indications, characteristics, and outcomes of cardiovascular implantable electronic device (CIED) surgery in patients with LVAD.Many patients with a left ventricular assist device (LVAD) will require implantable cardioverter-defibrillator generator change or device revision or are candidates for de novo implantable cardioverter-defibrillator implantation following LVAD implantation.We performed an observational retrospective study of all LVAD recipients who subsequently underwent CIED surgery at Duke University Hospital from 2009 to 2019.A total of 159 patients underwent CIED surgery following LVAD implantation, including generator change (n = 93), device revision (n = 38), and de novo implant (n = 28). The median (interquartile range) time from LVAD implantation to CIED surgery was 18.1 months (5.5 to 35.1 months). Pre-operative risk for infection was elevated in the overall cohort with a median (interquartile range) Prevention of Arrhythmia Device Infection Trial (PADIT) score of 7.0 (5.0 to 9.0). Pocket hematoma occurred in 21 patients (13.2%) following CIED surgery. Antimicrobial envelops were used in 43 patients (27%). Device infection due to CIED surgery occurred in 5 (3.1%) patients and occurred only in patients who developed post-operative pocket hematoma (p 0.001). Mortality at 1 year following CIED surgery was 20% (n = 32).CIED surgery following LVAD implantation is associated with an increased risk for pocket hematoma and CIED infection. Further studies are needed to determine the risk-benefit ratio of CIED surgery in patients with LVADs.

Objectives The goal of this study was to assess the utility of transvenous lead extraction for cardiovascular implantable electronic device (CIED) infection in patients with a left ventricular assist device (LVAD). Background The utility of transvenous lead extraction for the management CIED infection in patients with a durable LVAD has not been well described. Methods Clinical and outcomes data were collected retrospectively among patients who underwent lead extraction for CIED infection after LVAD implantation at Duke University Hospital. Results Overall, 27 patients (n = 6 HVAD; n = 15 HeartMate II; n = 6 Heartmate III) underwent lead extraction for infection. Median (interquartile range) time from LVAD implantation to infection was 6.1 (2.5, 14.9) months. Indications included endocarditis (n = 16), bacteremia (n = 9), and pocket infection (n = 2). Common pathogens were Staphylococcus aureus (n = 10), coagulase-negative staphylococci (n = 7), and Enterococcus faecalis (n = 3). Sixty-eight leads were removed, with a median lead implant time of 5.7 (3.6, 9.2) years. Laser sheaths were used in all procedures, with a median laser time of 35.0 (17.5, 85.5) s. Mechanical cutting tools were required in 11 (40.7%) and femoral snaring in 4 (14.8%). Complete procedural success was achieved in 25 (93.6%) patients and clinical success in 27 (100%). No procedural failures or major adverse events occurred. Twenty-one patients (77.8%) were alive without persistent endovascular infection 1 year after lead extraction. Most were treated with oral suppressive antibiotics after extraction (n = 23 [82.5%]). Persistent infection after extraction occurred in 4 patients and was associated with 50% 1-year mortality. Conclusions Transvenous lead extraction for LVAD-associated CIED infection can be performed safely with low rates of persistent infection and 1-year mortality.

Background Subclavian artery revascularization is frequently performed in the setting of thoracic endovascular aortic repair (TEVAR). However, there is little information on the short- and long-term outcomes of patients undergoing carotid to subclavian artery bypass in this clinical setting. As such, this study sought to define the early and late outcomes associated with this procedure. Methods Patients undergoing carotid-subclavian bypass in conjunction with TEVAR between June 2005 and September 2016 were retrospectively identified from a prospectively maintained, single-center aortic surgery database. The 30-day outcomes specific to the carotid-subclavian bypass procedure were analyzed, including cervical plexus nerve injury, bleeding complications, and local vascular complications. All preoperative and postoperative chest radiographs were carefully analyzed to assess for hemidiaphragm elevation indicative of phrenic nerve palsy. Long-term outcomes included primary graft patency and anastomotic complications. Results Of 579 consecutive patients undergoing TEVAR during this time interval, 112 patients (19%) underwent concomitant carotid-subclavian bypass. The cohort was 38% female (n = 43), with a mean age of 65 ± 14 years. The majority of conduits were 8-mm polytetrafluoroethylene grafts (n = 107 [95.5%]), with a minority being reversed saphenous vein (n = 4 [3.6%]) or Dacron (n = 1 [0.9%]) grafts. The bypass procedure was done concurrently at the time of TEVAR in 91% (n = 102) of cases. The short-term complication rate attributed specifically to the carotid-subclavian bypass was 29% (n = 33). These complications included phrenic nerve palsy in 25% (n = 27), recurrent laryngeal nerve palsy in 5% (n = 6), axillary nerve palsy in 2% (n = 2), and neck hematoma requiring re-exploration in 1% (n = 1) of patients. The 30-day in-hospital all-cause mortality rate was 5% (n = 6), and the rate of permanent paraparesis or paraplegia was 0.9% (n = 1). Of the operative survivors (n = 106), follow-up imaging of the bypass graft was available in 87% (n = 92) of patients. Actuarial primary graft patency was 97% at 5 years. There were three patients (3%) with bypass graft occlusions, two of which were clinically silent and detected on follow-up imaging. The third was detected because of symptoms of subclavian steal and required repeated revascularization. Two patients (2%) developed a late anastomotic pseudoaneurysm requiring either endovascular (n = 1) or surgical (n = 1) intervention. Conclusions Carotid-subclavian bypass for revascularization of the subclavian artery performed in the setting of TEVAR is durable, although the true complication rate is likely higher than is generally reported in the literature because of a not insignificant rate of phrenic nerve palsy. These data should serve well as “gold standard” comparison data for emerging branch graft devices.

BACKGROUND: Donors with characteristics that may increase the likelihood of disease transmission with transplantation are noted as increased risk via Public Health Service criteria. This study aimed to establish the implications of declining an increased-risk donor (IRD) organ offer in lung transplantation. METHODS: Adult candidates waitlisted for isolated lung transplantation in the United States using the Organ Procurement and Transplantation Network/United Network of Organ Sharing registry from 2007 to 2017 were identified. Individual match run files identified candidate recipients who matched to an IRD offer. Competing-risks analysis ascertained the likelihood of survival to transplantation. A stratified Cox model and restricted mean survival times estimated the survival benefit associated with the acceptance of an IRD organ. RESULTS: A total of 6,963 candidates met inclusion criteria, and 1,473 (21.2%) accepted an IRD offer. Candidates who accepted an IRD offer were older, more likely to be male, and had a higher lung allocation score at the time of listing (all p < 0.05). At 1 year after an IRD offer decline, 70.5% of candidates underwent a lung transplant, 13.8% died or decompensated, and 14.9% were still awaiting transplant. Compared with those who declined, candidates who accepted the IRD offer had significantly improved cumulative mortality at 1 year (14.1% vs 23.9%, p < 0.001) and 5 years (48.4% vs 53.8%, p < 0.001). CONCLUSIONS: IRD organ declination is associated with a decreased rate of lung transplantation and worse survival. Overall post-transplant survival rates for those who survive to transplantation are equivalent.

Background Results of hybrid arch repair (HAR) using the native zone 0 proximal landing zone (PLZ) have been unsatisfactory in many series, especially in the setting of ascending aortic dilation (>4.0 cm). This study reports early and late outcomes of planned two-stage HAR with open first-stage proximal aortic replacement, followed by second-stage thoracic endovascular aortic repair (TEVAR) with PLZ within the Dacron-replaced zone 0. Methods Between January 2006 and August 2017, 34 patients underwent planned two-stage HAR. The first-stage proximal aortic replacement included ascending aorta (with or without valve, with or without root) and total arch replacement, which was performed with creation of an elephant trunk in 22 patients (65%) and without an elephant trunk in 12 (35%). Primary outcomes included 30-day/in-hospital results and Kaplan-Meier estimates of overall/aorta-specific survival and freedom from reintervention. Results Mean age was 59 ± 12 years. Both stages of repair were completed in a single hospitalization in 53% of patients, including operations done since January 2012. The 30-day/in-hospital rates of mortality, stroke, permanent paraparesis/plegia, and new dialysis were 6%, 3%, 0%, and 0%, respectively. Kaplan-Meier overall and aorta-specific survivals at 5 years were 63% and 94%, respectively, with 5-year freedom from reintervention of 78%. Conclusions Planned two-stage HAR with open first-stage proximal aortic replacement, followed by second-stage TEVAR with Dacron-replaced PLZ yields excellent short-term and long-term results, including low rates of reintervention likely due to the long-segment PLZ within the Dacron-replaced aorta. The technique should be considered in patients with even mild (>4.0 cm) ascending aortic dilation in whom HAR is otherwise the preferred treatment option.

Purpose An increasing number of patients with end-stage heart failure are supported with left ventricular assist device (LVAD) implantation and must be maintained on a consistent anticoagulation regimen. Pre-emptive extraction of carious teeth in these patients is necessary to prevent seeding of the implanted device and endocarditis. Thus, the objective of this study was to evaluate bleeding complications after minor oral surgery, specifically teeth extractions, in this unique patient population requiring long-term anticoagulation. Materials and Methods This study was a retrospective single-center review. Adult patients supported on an implanted continuous-flow LVAD from January 1, 2007 to December 31, 2016 were included. Baseline characteristics were collected by retrospective chart review and the institutional LVAD registry. All extractions were performed in the operating room under local anesthesia with moderate sedation or general anesthesia with nasal intubation, and LVAD settings were monitored by a trained perfusionist. Preoperative and postoperative hematology laboratory values, such as hemoglobin and international normalized ratio (INR), were collected by chart review. Continuous variables were presented as mean ± standard deviation and compared using the Student t test. Categorical variables were presented as proportion and percentage and compared using the χ2 test or Fisher exact test as appropriate. Statistical significance was established at a P value less than .05. Results After screening 798 patients, 32 (4%) were found to have undergone dental extractions after LVAD implantation. The sample was composed of 32 patients with a mean age of 60.13 years and 81.25% were men. The average time from LVAD implantation to extraction was 445.19 ± 1,108.53 days. Average preoperative INR was 1.76 ± 0.47. Preoperative fresh frozen plasma was not administered to any patients. Twenty-eight patients (87.5%) were on Coumadin (warfarin) preoperatively. In 11 of these 28 patients (39.3%), Coumadin was held preoperatively. The average postoperative change in hemoglobin level was −0.79 ± 1.45. Only 1 patient (3%) required postoperative blood transfusion for a hemoglobin level of 7.6 that responded appropriately. There were no reoperations for bleeding. Conclusions Minor oral surgical procedures can be performed safely for patients being supported on LVAD therapy. With primary closure of the gingiva at the site of extraction, dental extractions can be performed without the full reversal of anticoagulation.

Background For advanced coronary disease, coronary artery bypass graft (CABG) surgery generally improves patients' symptoms and long-term survival. Unfortunately, some patients experience worse health-related quality of life (HRQL) after CABG. The objective of this study is to report the frequency and risk factors associated with 1-year post-CABG HRQL deterioration. Methods From 2002 to 2007, 2203 “Randomized On/Off Bypass” (ROOBY) trial patients randomly received either off-pump or on-pump CABG at 18 VA medical centers. Subjects completed both baseline and 1-year Seattle Angina Questionnaire (SAQ) and the Veterans Rand 36 (VR-36) questionnaires to assess HRQL. Using previously published criteria, the rates of clinically significant changes were determined for the SAQ [angina frequency (AF), physical limitation (PL), and quality of life (QoL)] and VR36 [mental component score (MCS) and physical component score (PCS)] subscales. Multivariate regression models were then used to identify pre-CABG patient characteristics associated with worsened 1-year HRQL status for each subscale. Results Over 80% of patients had an improvement or no change in SAQ and VR-36 subscale scores 1 year after CABG. The HRQL scale-specific deterioration rates were 4.5% SAQ-AF, 16.8% SAQ-PL, 4.9% SAQ-QoL, 19.4% VR36-MCS, and 13.5% VR36-PCS. Predictors of 1-year HRQL deterioration were diabetes and smoking for the SAQ-AF; diabetes, chronic obstructive pulmonary disease (COPD), and peripheral vascular disease (PVD) for SAQ-PL; COPD and depression for the SAQ-QoL; diabetes for VR36-PCS, and history of stroke and depression for VR36-MCS. The baseline score was an independent predictor for worsening in all the subscales studied. Conclusions Among VA patients, less than 20% experienced worse HRQL 1 year after CABG. For patients with low symptom burden at baseline, diabetes, smoking, depression, PVD, COPD, and a prior stroke, clinicians should be more cautious in pre-CABG counseling as to their anticipated HRQL improvements.

Optimal antiplatelet therapy after coronary artery bypass graft (CABG) surgery remains controversial. This study evaluated the role of dual antiplatelet therapy using aspirin and clopidogrel (DAPT) versus antiplatelet therapy using aspirin only (ASA) on post-CABG clinical outcomes and costs. In the Department of Veterans Affairs Randomized On/Off Bypass (ROOBY) trial, clopidogrel use after CABG was prospectively collected beginning in year 2 of this study to include 1,525 of the 2,203 original ROOBY patients who received aspirin after CABG. Discretionarily, surgeons after CABG administered either DAPT or ASA treatments. The ROOBY trial's primary 30-day composite (mortality or perioperative morbidity), 1-year composite (all-cause death, repeat revascularization, or nonfatal myocardial infarction), and costs were compared for these 2 strategies. Of the 1,525 subjects, 511 received DAPT and 1,014 received ASA. DAPT subjects, compared with ASA subjects, had lower rates of preoperative left ventricular ejection fraction of ≥45% (78.8% vs 85.7%, p 0.001), on-pump CABG (36.6% vs 57.1%, p = 0.001), and endoscopic vein harvesting (30.0% vs 42.8%, p 0.001). ASA patients were more likely to have earlier aspirin administration and receive 325 versus 81 mg dosages. The 30-day composite outcome rate was significantly lower for DAPT patients compared with ASA patients (3.3% vs 7.1%, p = 0.003), but the 1-year composite outcome was equal between the 2 groups (12.0% vs12.0%, p = 1.0). At 1 year, there were no cost differences between the 2 groups. Propensity analyses did not significantly alter the results. In conclusion, DAPT appeared safe and was associated with fewer 30-day adverse outcomes than aspirin only and with no 1-year outcome or cost differences.

Programmed death-ligand 1 (PD-L1), a transmembrane protein and member of the CD28 T cell family is associated with lymphocyte activation.1 PD-L1 expression is upregulated on activated antigen presenting cells such as monocytes, myeloid and dendritic cells.2 When bound to its cognate receptor programmed cell death (PD-1), inhibition of immune responses including downregulation of T cell proliferation occurs.3 Mechanistically, such inhibition would be hypothetically favorable in the setting of a transplanted organ undergoing allograft rejection. However, there is a paucity of data addressing the role of PD-L1 and PD-1 expression in the human transplanted heart.

BACKGROUND Our objective was to identify potential avenues for resource allocation and patient advocacy to improve outcomes by evaluating the association between recipient sociodemographic and patient characteristics and medication nonadherence after lung transplantation. METHODS States US adult, lung-only transplantations per the United Network for Organ Sharing database were analyzed from October 1996 through December 2006, based on the period during which nonadherence information was recorded. Generalized linear models were used to determine the association of demographic, disease, and transplantation center characteristics with early nonadherence (defined as within the first year after transplantation) as well as late nonadherence (years 2 to 4 after transplantation). Outcomes comparing adherent and nonadherent patients were also evaluated. RESULTS Patients (n = 7,284) were included for analysis. Early and late nonadherence rates were 3.1% and 10.6%, respectively. Factors associated with early nonadherence were Medicaid insurance compared with private insurance (adjusted odds ratio [AOR] 2.45, 95% confidence interval [CI]: 1.16 to 5.15), and black race (AOR 2.38, 95% CI: 1.08 to 5.25). Medicaid insurance and black race were also associated with late nonadherence (AOR 2.38, 95% CI: 1.51 to 3.73 and OR 1.73, 95% CI: 1.04 to 2.89, respectively), as were age 18 to 20 years (AOR 3.41, 95% CI: 1.29 to 8.99) and grade school or lower education (AOR 1.88, 95% CI: 1.05 to 3.35). Early and late nonadherence were both associated with significantly shorter unadjusted survival (p < 0.001). CONCLUSIONS Identifying patients at risk of nonadherence may enable resource allocation and patient advocacy to improve outcomes.

Purpose Cardiac gene therapy remains limited by inefficient transgene delivery with currently available methods (intravenous infusion, transcatheter coronary artery infusion, direct myocardial injection). We previously demonstrated in a porcine heterotopic heart transplant model that cardiac allograft gene transfer can be achieved using ex vivo perfusion with adenovirus (Ad). Adeno-associated viral (AAV) vectors generally achieve lower transgene expression compared to Ad. However, AAV vectors also achieve a significantly longer duration of expression, and thus are more suitable for therapies with genes that are effective even at lower levels but require prolonged expression. The purpose of this study is to evaluate whether ex vivo perfusion can also be used as a platform for cardiac allograft gene therapy using AAV. Methods Heart transplantation was performed using blood type-matched and swine leukocyte antigen-matched Yucatan mini pigs (n=2 transplants). Donor hearts received ex vivo perfusion for two hours with a perfusate including AAV vector bearing the firefly luciferase gene (dosed at 2 × 10^13 and 1 × 10^14 genome-containing vectors for transplants 1 and 2, respectively). The allograft was implanted heterotopically into the recipient abdomen. Recipients were survived for 30 days on oral immunosuppression and then euthanized. Transgene expression in allograft and native recipient tissues was assessed using a luciferase enzymatic assay, and transgene detection was performed using qPCR on DNA extracted using a modified Hirt protocol. Results Luciferase activity was detected in the allograft in both experiments. While luciferase activity was undetectable in the right and left atria and coronary arteries from the allograft exposed to the lower dose, the higher dose of AAV resulted in detectable luciferase activity throughout the entire heart and at high levels. Luciferase activity was undetectable in all recipient tissues (heart, lung, liver, spleen, and psoas muscle). Additionally, luciferase DNA was detectable on qPCR in allograft specimens (1.5-1.9 × 10^3 transgene copies per 100 ng of DNA). Conclusion Ex vivo perfusion can be used as a platform for cardiac allograft gene therapy using AAV vectors, with robust transgene expression detectable 30 days following transplant.

Purpose Significant tricuspid regurgitation (TR) in patients undergoing durable left ventricular assist device (LVAD) implantation has been associated with increased incidence of right heart failure (RHF). There is great surgical practice variability related to moderate TR repair at the time of LVAD implantation. In this single-center study, we investigated whether moderate TR repair concurrent with LVAD implantation has impact on late RHF occurrence. Methods We gathered data on adult patients undergoing durable LVAD implantation between 2009 and 2017. Only patients with moderate TR at the time of LVAD implantation constituted the study cohort. Patients were separated in two groups, concurrent tricuspid valve repair (TVr group) and no-TVr group. LateRHF was defined as any readmission for HF, requiring treatment with diuretics or inotropes or implantation of a right ventricular assist device. Unrepaired TR was categorized as improved if it was persistently graded as mild or less on post-operative echocardiographic studies. TVr failure was defined as moderate or severe TR on any post-operative echocardiographic study. Kaplan-Meier curves were used to analyze freedom from late RHF between the two groups. Results Out of 140 patients, 92 (65%) were in the TVr group. TVr failure was present in 35 (38%) of these patients. Out of the 48 patients in the no-TVr group, 22 (45%) experienced improvement of TR. Late RHF occurred in 12 (25%) patients in the no-TVr group and 35 (38%) patients in the TVr group. There was no event-free survival difference between the two groups (log rank p=0.678)(Figure). Conclusion In our study cohort, we found no benefit in concurrent TVr for moderate TR at LVAD implantation on late RHF occurrence. Moreover, 45% of the patients with unrepaired moderate TR experienced improvement of TR, while 38% of patients with TVr experienced repair failure. Future randomized studies should address and confirm these results.

Cardiac transplantation (HTX) is the gold standard and is an increasingly utilized therapy for patients with end-stage heart failure [(1)][1]. Strategies to reduce the risk of waitlist mortality remain urgently needed. The Public Health Service defines increased risk donors (IRDs) as donors who

Patients with chronic obstructive pulmonary disease (COPD) are at inherent risk for higher rates of adverse events after coronary artery bypass graft surgery (CABG). As compared with on-pump CABG (ONCAB), it has been suggested that beating heart or off-pump CABG (OPCAB) may differentially benefit high-risk COPD patients.Intraoperative, 30-day and 1-year outcomes were compared for COPD patients randomized to OPCAB (n = 220) versus ONCAB (n = 238) within the Veterans Affairs' Randomized On/Off Bypass (ROOBY) trial. As COPD patients may more likely incur adverse post-CABG outcomes, a propensity analysis was performed comparing all ROOBY patients with COPD (n = 458) versus those without COPD (n = 1,745).For COPD patients, the baseline characteristics were similar between the 2 revascularization approaches. In these patients, the intraoperative complication rate was higher with OPCAB than ONCAB (21.9% vs 10.1%, respectively; p0.001), but there were no significant differences in the 30-day (7.3% vs 7.6%, p = 1.00) or 1-year composite outcome rates (9.5% vs 7.1%, p = 0.39) between the groups. Comparing the COPD patients with propensity-matched non-COPD patients, there was no difference in 1-year major adverse cardiovascular events (including the 1-year composite major adverse cardiac events (MACE) outcome, as well as the individual MACE outcomes for all cause death, acute myocardial infarction, or repeat revascularization).In COPD patients, there were more intraoperative complications and no differences in 30-day or 1-year outcomes with OPCAB as compared with ONCAB. Similar to patients without COPD, there was no benefit to using an OPCAB approach in COPD patients.

Background Non–small cell lung cancer (NSCLC) has a predilection to occur in emphysematous lungs. The relation between the regional severity of emphysema and the location of NSCLC as well as long-term survival has been poorly studied. Methods Computed tomography (CT) scans of 153 patients with biopsy-proven stage I NSCLC diagnosed between 2001 and 2006 were assigned an emphysema severity score in four regions of the lung. The location of the cancer was compared with the severity of emphysema in that region. Survival was also analyzed. Results Thirty-nine patients had no emphysema documented on CT scan and 114 did. The most common location of cancer was the right upper quadrant with 37% of cancers, followed by the left upper quadrant with 23% of cancers. Twenty-two percent of the cancers occurred in the right lower quadrant, and only 12% were in the left lower quadrant. There is a strong association for cancer being located in the area with the highest degree of emphysema (P

Questions have been raised about the costs and outcomes for patients receiving on-pump and off-pump coronary artery bypass graft surgery. As part of the Department of Veterans Affairs Randomized On/Off Bypass (ROOBY) multisite trial, a cost-effectiveness analysis was performed to compare on-pump versus off-pump patients' quality-adjusted life-years and costs at 1 year.One-year outcomes and costs (standardized to 2010 dollars) were estimated in multivariate regression models, controlling for site and baseline patient factors. The 1-year incremental cost-effectiveness analysis ratio with 95% confidence intervals was calculated using bootstrapping.Eighteen centers randomly assigned 2,203 participants to on-pump (n=1,099) versus off-pump (n=1,104) coronary artery bypass graft surgery. Both groups' quality of life improved significantly after surgery (p0.01) compared with baseline, but no differences were found between treatment groups. Adjusted cost of the index coronary artery bypass graft surgery hospitalization was $36,046 on-pump and $36,536 off-pump (p=0.16). At 1 year, on-pump adjusted cost was $56,023 versus $59,623 off-pump (p=0.046). Off-pump-to-on-pump conversions after first distal anastomosis (4.8%) had significantly higher 1-year costs. Excluding conversions, there were no significant differences between treatments for index hospitalization or 1-year total costs.At 1 year, off-pump coronary artery bypass graft surgery was more expensive than on-pump when late off-pump-to-on-pump conversions were included. Excluding late conversions, there was no difference in quality-adjusted life-years or costs.ClinicalTrials.gov identifier NCT00032630; http://clinicaltrials.gov/ct2/show/NCT00032630.

Background The relative benefits of performing coronary artery bypass graft surgery off-pump versus on-pump continue to be debated. A critical, patient-centered outcome is health-related quality of life; yet there has been limited evaluation in large-scale, multicenter trials of the off-pump versus on-pump impact upon quality of life. Methods The Veterans Affairs Randomized On/Off Bypass trial randomized 2,203 nonemergent patients to off-pump or on-pump from February 2002 to May 2007. Patients completed a general quality of life survey (VR-36) and a disease-specific quality of life survey, the Seattle Angina Questionnaire (SAQ), prior to surgery, then again at 3 and 12 months post-bypass. Results Of the 2,130 1-year survivors, 1,805 patients (85%) completed 1-year surveys. Randomization resulted in comparable baseline patient characteristics, including VR-36 and SAQ scores. At 3 months and 1-year post-procedure, there were no clinically relevant differences between off-pump and on-pump patients in any of the quality of life measures. Both groups had statistically significant, comparable improvements in the physical component scale of the VR-36, and in the SAQ scales. Conclusions For this trial's male, low-to-moderate risk, veteran population, there were no significant differences between off-pump and on-pump with regard to 1-year general and disease-specific quality of life outcomes. Both treatment arms experienced some improvements by 3 months, with continued improvements through 1-year post-bypass.

Surgical resection remains the standard of care for operable early-stage non-small-cell lung cancer (NSCLC). However, some patients are not fit for surgery because of comorbidites such as chronic obstructive pulmonary disease (COPD) and other medical conditions. We aimed to evaluate pulmonary function and tumor volume before and after stereotactic body radiotherapy (SBRT) for patients with and without COPD in early-stage lung cancer.A review of prospectively collected data of Stage I and II lung cancers, all treated with SBRT, was performed. The total SBRT treatment was 60 Gy administered in three 20 Gy fractions. The patients were analyzed based on their COPD status, using their pretreatment pulmonary function test cutoffs as established by the American Thoracic Society guidelines (forced expiratory volume [FEV]% ≤ 50% predicted, FEV%/forced vital capacity [FVC]% ≤ 70%). Changes in tumor volume were also assessed by computed tomography.Of a total of 30 patients with Stage I and II lung cancer, there were 7 patients in the COPD group (4 men, 3 women), and 23 in t he No-COPD group (9 men, 14 women). At a mean follow-up time of 4 months, for the COPD and No-COPD patients, pretreatment and posttreatment FEV% was similar: 39 ± 5 vs. 40 ± 9 (p = 0.4) and 77 ± 0.5 vs. 73 ± 24 (p = 0.9), respectively. The diffusing capacity of the lungs for carbon monoxide (DL(CO)) did significantly increase for the No-COPD group after SBRT treatment: 60 ± 24 vs. 69 ± 22 (p = 0.022); however, DL(CO) was unchanged for the COPD group: 49 ± 13 vs. 50 ± 14 (p = 0.8). Although pretreatment tumor volume was comparable for both groups, tumor volume significantly shrank in the No-COPD group from 19 ± 24 to 9 ± 16 (p0.001), and there was a trend in the COPD patients from 12 ± 9 to 6 ± 5 (p = 0.06).SBRT did not seem to have an effect on FEV(1) and FVC, but it shrank tumor volume and improved DL(CO) for patients without COPD.

TAVR continues to be associated with variability in hospital outcomes. While some complications may not be preventable, the ability to rapidly diagnose and “rescue” (Failure to Rescue, FTR) a patient from a complication relates to the quality of care of the health care system Patients

Post-operative atrial fibrillation (POAF) is common after cardiac surgery. However, few studies examine the effect on early and late outcomes following thoracic aortic surgery. Patients (n=993) who underwent proximal aortic surgery, without pre-operative atrial fibrillation (n=135), at a single

Objective Controversy exists regarding ideal approaches in teaching residents complex and/or new surgical techniques in part because consequences on patient outcomes are largely unknown. This study compared patient outcomes for cases in which residents (rather than attending surgeons) performed most of the distal anastomoses as primary surgeons, during on- and off-pump coronary artery bypass grafting (CABG). Methods This preapproved substudy of the Randomized On/Off Bypass (ROOBY) trial compared clinical outcomes and 1-year graft patency for cases in which residents versus attending surgeons were the primary operator. Comparisons were made between on-pump and off-pump techniques. Results From July 2003 through May 2007, a total of 1272 ROOBY nonemergent CABG patients were randomized at 16 Veterans Affairs centers where residents were active participants. Residents were the primary surgeon (ie, performed ≥50% of the distal anastomoses) more frequently in on-pump (77.9%) than in off-pump (67.4%) cases. Between these 2 techniques, no were found differences in baseline patient characteristics; short-term and 1-year morbidity and mortality rates were no different for residents versus attendings in CABG cases. FitzGibbon A graft patency rates were similar for resident versus attendings completed distal anastomoses for on-pump (83.0% vs 82.4%) compared with off-pump (77.2% vs 76.6%) procedures. Conclusions In the ROOBY trial, short-term and 1-year patient outcomes and graft patency rates did not differ between resident and attending surgeons, demonstrating that with appropriate patient selection and resident supervision, residents can perform advanced, novel surgical techniques with outcomes similar to those of attending surgeons.

In patients with multivessel coronary artery disease, bypass surgery improves long-term angina symptoms compared to percutaneous coronary intervention, presumably by providing a more complete revascularization (CR). However, data correlating patient-reported symptoms and CR post-bypass are lacking

Su1463 Simulated NOTES Sigmoidectomy Training Improves the Responsiveness Over Time of Surgical Endoscopists Jonathan Buscaglia*, Seth A. Stein, Nicholas Palladino, Joshua Karas, Paula Denoya, Juan Carlos Bucobo, Satish Nagula, Muath Bishawi, Roberto Bergamaschi Medicine, Stony Brook University, Stony Brook, NY; Surgery, Stony Brook University, Stony Brook, NY Background: Transanal sigmoid colon resection by natural orifice transluminal endoscopic surgery (NOTES) may be a feasible clinical procedure if performed by highly-skilled, trained endoscopists. A model and training protocol has yet to be established for a completely incissionless NOTES sigmoidectomy. Objective: 1) to develop a model for simulated NOTES sigmoidectomy training; 2) to validate the model by assessing the responsiveness of endoscopists over time during a series of training sessions. Methods: Attending endoscopists (2 colorectal surgeons, 2 interventional gastroenterologists) underwent simulated NOTES sigmoidectomy training using disposable abdominal trays with tattooed sigmoid cancers in a hybrid simulator model (Fig 1). The 8-step standardized technique was performed transanally with a double-channel therapeutic upper endoscope, a single adult colonoscope, endoscopic hemoclips, & endoscopic scissors in the following order: 1) viscerotomy with balloon dilation from the rectum; 2) retroperitoneal access/dissection; 3) left ureter identification, inferior mesenteric artery and vein division; 4) colonoscopy to the right colon to provide traction & aide in subsequent splenic flexure mobilization; 5) flexure mobilization; 6) left colon and rectal mobilization; 7) transanal specimen transection; 8) extracorporeal colorectal anastomosis. After a baseline testing procedure, endoscopists underwent 4 training sessions mentored by an expert surgical endoscopist before proceeding to an unmentored final test with predetermined proficiency criteria. Responsiveness was defined as change in performance over time, & was assessed by comparing baseline testing with unmentored final test times. Results: 4 physicians successfully completed 21 resections. Tumors were located at a median distance of 29.2cm from the anal verge (range 26-32.5). Overall, there was a 42% reduction in total operating time (median 127.5v74min, p 0.068). A non-significant trend towards improvement in median time values (in min) was noted for the following variables: successful viscerotomy (17.5v9,p 0.197), access to retroperitoneum (21.5v11.5,p 0.144), identification/ligation of ureter/vessels (9v0.5,p 0.068), colonoscopy (4.5v3.5, p 0.655), mobilization of splenic flexure (19.5v10, p 0.144), mobilization of left colon (20v14.5, p 0.461), specimen retrieval (9.5v8.5,p 0.465), & creation of anastomosis (14v11,p 0.715). During training there were 2 conversions to laparotomy (9.5%) due to left iliac artery injury and colonic perforation. No complications occurred during final test procedures. Conclusions: Simulated NOTES sigmoidectomy training is feasible and impacted responsiveness in attending physicians with a 42% reduction in operating time. Further studies are warranted to assess the utility of simulator training when NOTES sigmoidectomy is performed in human models.