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Long-term continuous-flow left ventricular assist device (CFLVAD) therapy is limited by complications. Compared with stroke and renal dysfunction, post-CFLVAD bowel ischemia is poorly characterized. Adult patients who underwent first-time durable CFLVAD implantation at our institution between 2008 and 2018 were identified and screened for bowel ischemia using Current Procedural Terminology codes for abdominal surgical exploration and International Classification of Disease codes for intestinal vascular insufficiency. Patients who developed biopsy-proven bowel ischemia (cases) were matched to controls (1:1, nearest neighbor, caliper = 0.29) based on preoperative characteristics. Incidences of postoperative right heart failure and renal replacement therapy were compared using McNemar's test. One year survival was estimated using the Kaplan-Meier method. Overall, 711 patients underwent CFLVAD implantation. Nineteen (2.7%) developed bowel ischemia (cases) median 17 days postimplantation (IQR 8-71). The majority of cases were male (78.9%), Black (63.2%), received HeartMate II (57.9%), treated as destination therapy (78.9%), and had a history of hypertension (89.5%), chronic kidney disease (84.2%), hyperlipidemia (84.2%), smoking (78.9%), and atrial fibrillation (57.9%). Post-LVAD, case patients were more likely to develop moderate-severe right heart failure (89.5% vs. 68.4%, p = 0.005), require renal replacement therapy (21.1% vs. 0%, p < 0.001), and less likely to survive to discharge (52.6% vs. 89.5%, p = 0.02) compared with controls. Case subjects demonstrated worse 1 year survival. While less common than stroke and renal dysfunction, post-CFLVAD bowel ischemia is associated with high 1 year mortality. Multi-institutional registries should consider reporting abdominal complications such as bowel ischemia as an adverse event to further investigate these trends and identify predictors of this complication to reduce patient mortality.

The durability of surgical repair for degenerative versus ischemic mitral regurgitation (MR) is thought to be markedly different. We, therefore, examined late outcomes and durability for mitral repair in a large cohort of patients receiving a single annuloplasty device.A total of 749 consecutive patients receiving mitral repair for degenerative mitral regurgitation (DMR) or ischemic mitral regurgitation (IMR) were evaluated from a prospective database. Patients with tricuspid or maze surgery were included. Papillary muscle rupture and mixed valve etiologies were excluded. Outcomes were compared for IMR versus DMR.Patients with DMR were younger and less urgent. Patients with IMR had mean end-systolic diameter 4.5 ± 1.1 cm. All patients received the same complete semirigid annuloplasty device with median ring size 32 mm for DMR and 24 mm for IMR. New York Heart Association failure class improved from 2.8 to 1.5 (p .001). Patients with DMR had lower operative mortality (1/384 [0.3%] vs. 26/365 [7%], p .0001) and shorter length of stay. A 15-year survival was better with DMR (63% ± 3% vs. 13% ± 2%, p .001). At 10 years, the incidence of recurrent ≥2+ MR (10% ± 2% vs. 16% ± 2%, p = .16) was not significantly different. Predictors of recurrent ≥2+ MR were female gender (odds ratio [OR]: 3.0 (1.9-4.8, p .0001), and prior operation (OR: 2.4 [1.3-4.5], p = .02) but not IMR (OR: 1.4 [0.9-2.3], p = .15).In this series, where patients with IMR had relatively preserved ventricular dimensions, the primary determinants of late recurrent MR were female gender and prior operation but not IMR versus DMR. Selected patients with IMR can obtain relatively durable mitral repair despite higher operative risk and lower survival compared to DMR.

Poor preoperative health-related quality of life (HRQoL) has been associated with reduced short-term survival after coronary artery bypass graft (CABG) surgery; however, its impact on long-term mortality is unknown. This study's objective was to determine if baseline HRQoL status predicts 5-year post-CABG mortality.This prespecified, randomized on/off bypass follow-up study (ROOBY-FS) subanalysis compared baseline patient characteristics and HRQoL scores, obtained from the Seattle Angina Questionnaire (SAQ) and Veterans RAND Short Form-36 (VR-36), between 5-year post-CABG survivors and nonsurvivors. Standardized subscores were calculated for each questionnaire. Multivariable logistic regression assessed whether HRQoL survey subcomponents independently predicted 5-year mortality (p ≤ .05).Of the 2203 ROOBY-FS enrollees, 2104 (95.5%) completed baseline surveys. Significant differences between 5-year post-CABG deaths (n = 286) and survivors (n = 1818) included age, history of chronic obstructive pulmonary disease, stroke, peripheral vascular disease, renal dysfunction, diabetes, lower left ventricular ejection fraction, atrial fibrillation, depression, non-White race/ethnicity, lower education status, and off-pump CABG. Adjusting for these factors, baseline VR-36 physical component summary score (p = .01), VR-36 mental component summary score (p .001), and SAQ physical limitation score (p = .003) were all associated with 5-year all-cause mortality.Pre-CABG HRQoL scores may provide clinically relevant prognostic information beyond traditional risk models and prove useful for patient-provider shared decision-making and enhancing pre-CABG informed consent.

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.

Background Short duration, antimicrobial prophylaxis that includes antistaphylococcal activity is recommended at the time of left ventricular assist device (LVAD) implantation to reduce infection-related complications. There continues to be wide variability in surgical infection prophylaxis (SIP) regimens among implantation centers. The aim of this study is to characterize current SIP regimens at different LVAD centers. Methods A survey study was conducted from 26 September 2017 to 25 October 2017. Surveys were distributed electronically to LVAD coordinators and infectious diseases specialists at 75 US medical centers identified as having an LVAD program. Data collection included information about antimicrobial selection, duration, Staphylococcus aureus screening, and decolonization procedures. Results We received 29 survey responses. The majority of surveys were completed by infectious diseases physicians (72.4% [21 out of 29]). Most responding centers reported LVAD programs established for greater than 10 years (20 out of 29 [69%]). Cardiac transplantation was performed in 28 out of 29 (96%) centers. Of centers reporting a defined SIP regimen for non-penicillin allergic patients (96% [28 out of 29]), 17.9% (5 out of 28) reported a four-drug regimen, 35.7% (10 out of 28) reported a three-drug regimen, and 46.4% (13 out of 28) reported a two-drug regimen, while no centers reported a single-drug regimen. Empiric fluconazole was common (50% [14 out of 28]) and 96.4% (27 out of 28) of regimens included vancomycin. Duration of antimicrobial prophylaxis (24 hours to 5 days), S. aureus screening, decolonization procedures, and alterations due to drug allergies varied across participating centers. Conclusions Our survey results indicate wide variation in SIP regimens among participating LVAD centers. These results highlight the need for studies evaluating the implications of SIP regimens, and whether clinical factors that prolong antimicrobial duration impact postoperative infection rates.

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 There is no standard of care with respect to the use of neoadjuvant chemotherapy (NAC) in resectable malignant pleural mesothelioma (MPM). We performed an intention-to-treat analysis with data from a single institution and the National Cancer Database (NCDB) to identify whether the use of NAC impacts survival in resectable MPM. Methods Patients with MPM who had surgery with curative intent at Duke University from 1995 to 2017 were selected, and the 2004–2015 NCDB was used to identify MPM patients with clinical stage I–IIIB who underwent definitive surgery. For both cohorts, patients were stratified by receipt of NAC. Primary outcomes were overall survival and postresection survival (RS), which were estimated using Kaplan-Meier and multivariable Cox proportional hazards models. Results A total of 257 patients met inclusion criteria in the Duke cohort. Compared with immediate resection (IR), NAC was associated with similar overall survival but an increased risk for postresection mortality in both unmatched (adjusted hazard ratio [HR] = 1.85, 95% confidence interval [CI] = 1.21 to 2.83) and propensity-matched (HR = 1.62, 95% CI = 1.03 to 2.55) cohorts. A total of 1949 NCDB patients were included: 1597 (81.9%) IR and 352 (18.1%) NAC. RS was worse for patients undergoing NAC in both unmatched (HR = 1.85, 95% CI = 1.21 to 2.83) and propensity-matched (HR = 1.29, 95% CI = 1.06 to 1.57) analyses compared with patients receiving IR. Conclusions In this intention-to-treat study, NAC was associated with worse RS compared with IR in patients with MPM. The risks and benefits of induction therapy should be weighed before offering it to patients with resectable MPM.

Cardiac transplantation remains the gold standard therapy for end stage heart failure. However, it remains limited by the number of available donor hearts and by complications such as primary graft dysfunction and graft rejection. The recent clinical use of an ex vivo perfusion device in cardiac transplantation introduces a unique opportunity for treating cardiac allografts with therapeutic interventions to improve function and avoid deleterious recipient responses. Establishing a translational, large-animal model for therapeutic delivery to the entire allograft is essential for testing novel therapeutic approaches in cardiac transplantation. The porcine, heterotopic heart transplantation model in the intra-abdominal position serves as an excellent model for assessing the effects of novel interventions as well as the immunopathology of graft rejection. This model additionally offers long-term survival for the pig given that the graft is not required to maintain the recipient’s circulation. The aim of this protocol is to provide a reproducible and robust approach for achieving ex vivo delivery of a therapeutic to the entire cardiac allograft prior to transplantation and provide technical details to perform a survival heterotopic transplant of the ex vivo perfused heart.

Stroke remains a significant complication of left ventricular assist device (LVAD) therapy. We performed a single-center retrospective study evaluating patients undergoing first-time HeartWare HVAD (Medtronic Inc) or HeartMate 3 (Abbott Inc) implantation from September 2009-February 2018.Exclusion criteria were age18 and preoperative ECMO. The primary endpoint was stroke-free survival. Stroke was defined as new neurological deficits persisting24 hours with corresponding radiographic evidence. Risk factors evaluated included demographics, medical comorbidities, heart failure etiology, LVAD indication, INTERMACS profile, and device type. Univariate predictors (P .15) and variables clinically suspected to raise stroke risk were entered in a multivariate hazard regression model, specified using backward selection of covariates and accounting for competing risks of transplant/LVAD exchange.A total of 163 HVAD and 84 HM3 patients were analyzed. Median follow up (until death, censoring for transplant/LVAD removal, or end of follow up) was 1.2 years in HVAD patients and 1.4 years in HM3 patients. Stroke occurred in 24 HVAD patients (15 ischemic, 9 hemorrhagic) and 6 HM3 patients (4 ischemic, 2 hemorrhagic). One-year stroke-free survival was 76.8% for HVAD and 84.3% for HM3. Thirty-day mortality following stroke was 41.7% for HVAD and 66.7% for HM3; 54.2% of HVAD strokes were disabling compared to 83.3% of HM3 strokes. Age, LVAD indication, and device type were associated (P .15) with stroke on univariate analysis. On multivariate analysis, the HVAD was associated with significantly higher stroke risk (hazard ratio, 2.57; 95% confidence interval, 1.02-6.44; P = .045).Different LVAD models appear to be associated with significantly different stroke risks.

Clinically, both percutaneous and surgical approaches to deliver viral vectors to the heart either have resulted in therapeutically inadequate levels of transgene expression or have raised safety concerns associated with extra-cardiac delivery. Recent developments in the field of normothermic ex vivo cardiac perfusion storage have now created opportunities to overcome these limitations and safety concerns of cardiac gene therapy. This study examined the feasibility of ex vivo perfusion as an approach to deliver a viral vector to a donor heart during storage and the resulting bio distribution and expression levels of the transgene in the recipient post-transplant. The influence of components (proprietary solution, donor blood, and ex vivo circuitry tubing and oxygenators) of the Organ Care System (OC) (TransMedics, Inc., Andover MA) on viral vector transduction was examined using a cell-based luciferase assay. Our ex vivo perfusion strategy, optimized for efficient Adenoviral vector transduction, was utilized to deliver 5 × 1013 total viral particles of an Adenoviral firefly luciferase vector with a cytomegalovirus (CMV) promotor to porcine donor hearts prior to heterotopic implantation. We have evaluated the overall levels of expression, protein activity, as well as the bio distribution of the firefly luciferase protein in a series of three heart transplants at a five-day post-transplant endpoint. The perfusion solution and the ex vivo circuitry did not influence viral vector transduction, but the serum or plasma fractions of the donor blood significantly inhibited viral vector transduction. Thus, subsequent gene delivery experiments to the explanted porcine heart utilized an autologous blood recovery approach to remove undesired plasma or serum components of the donor blood prior to its placement into the circuit. Enzymatic assessment of luciferase activity in tissues (native heart, allograft, liver etc.) obtained post-transplant day five revealed wide-spread and robust luciferase activity in all regions of the allograft (right and left atria, right and left ventricles, coronary arteries) compared to the native recipient heart. Importantly, luciferase activity in recipient heart, liver, lung, spleen, or psoas muscle was within background levels. Similar to luciferase activity, the luciferase protein expression in the allograft appeared uniform and robust across all areas of the myocardium as well as in the coronary arteries. Importantly, despite high copy number of vector genomic DNA in transplanted heart tissue, there was no evidence of vector DNA in either the recipient’s native heart or liver. Overall we demonstrate a simple protocol to achieve substantial, global gene delivery and expression isolated to the cardiac allograft. This introduces a novel method of viral vector delivery that opens the opportunity for biological modification of the allograft prior to implantation that may improve post-transplant outcomes.

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.

Intra-aortic balloon pump (IABP) is often used to support patients in decompensated heart failure. Placement of the IABP via the axillary artery facilitates long-term support with the device and may allow for the conversion of an acute heart failure (HF) patient into a chronic HF patient using a modified weaning protocol; allowing for medical symptom management and removal of mechanical support. We will discuss strategies for supporting these complicated patients.

Stroke is a devastating complication of left ventricular assist device (LVAD) therapy. Understanding the characteristics, risk factors and outcomes of strokes associated with the centrifugal flow LVADs is important to devise better strategies for management and prevention. This is a retrospective cohort study at a single US academic medical center. The cohort includes patients who received a first time Heartmate 3 (HM3) or Heartware (HVAD) LVAD between September 2009 through February 2018 and had a stroke while the LVAD was in place. Descriptive statistics were used when appropriate. A logistic regression analysis was used to determine predictors of poor outcome. Out of a total of 247 patients, 12.1% (N = 30, 24 HVAD and 6 HM3) had a stroke (63% ischemic) and 3 of these patients had pump thrombosis. Events per patient year (EPPY) were similar for HVAD and HM3 patients (0.3 ± 0.1). INR was subtherapeutic in 47.4% of ischemic stroke patients and supratherapeutic in 18.2% of hemorrhagic stroke patients. Concurrent infections were more common in the setting of hemorrhagic stroke than ischemic stroke (45.4% vs 5.3%, p = 0.008). Strokes were severe in most cases, with initial NIH stroke scale (NIHSS) higher in HM3 patients compared to HVAD patients (mean 24.6 vs 16) and associated with high in-patient mortality (21.1% of ischemic stroke vs. 88.8% of hemorrhagic stroke). Predictors of death within 30 days and disability at 90 days included creatinine at stroke onset, concurrent infection, hemorrhaghic stroke, and initial stroke severity (NIHSS). A score derived from these variables predicted with 100% certainty mortality at 30 days and mRS ≥ 4 at 90 days. For patients with centrifugal flow LVADs, ischemic strokes were more common but hemorrhagic strokes were associated with higher in-patient mortality and more frequently seen in the setting of concurrent infections. Infections, sub or supratherapeutic INR range, and comorbid cardiovascular risk factors may all be contributing to the stroke burden. These findings may inform future strategies for stroke prevention in this population.

There is currently no consensus regarding the optimal type of peritoneal dialysis catheter (PDC). We compared the outcomes of PDCs according to the number of cuffs, intercuff and intraperitoneal segment shape, and presence of a weighted tip.A systematic review of the literature was performed using the MEDLINE and Cochrane Library databases (end-of-search date: October 16th, 2019). We included studies comparing double-cuff vs. single-cuff, swan-neck vs. straight-neck, coiled-tip vs. straight-tip, and weighted vs. non-weighted PDCs for the outcomes of interest. We performed meta-analyses using the random-effects model. We assessed the risk of bias using the Newcastle-Ottawa scale and the Cochrane Collaboration's Tool.In total, 38 studies were identified, of which 20 were randomized controlled trials (RCTs) and 18 were observational studies. No statistically significant differences were detected between double-cuff vs. single-cuff, swan-neck vs. straight-neck, and coiled-tip vs. straight tip PDCs in any of the outcomes of interest. Weighted catheters were associated with significantly lower rates of tunnel infection (relative risk [RR] 0.52, 95% confidence interval [CI] 0.31-0.95, p = 0.03), migration (RR 0.07, 95% CI 0.03-0.16, p 0.001), drainage failure (RR 0.62, 95% CI 0.39-0.96, p = 0.03), cuff extrusion (RR 0.40, 95% CI 0.21-0.74, p 0.001), and complication-related removal (RR 0.53, 95% CI 0.44-0.64, p 0.001).Among the different types of PDCs, weighted catheters result in lower complication rates and superior long-term outcomes compared to non-weighted catheters. Other aspects of the catheter design do not significantly affect PDC outcomes.PROSPERO 2020 CRD42020158177.

Novel atherosclerosis models are needed to guide clinical therapy. Here, we report an in vitro model of early atherosclerosis by fabricating and perfusing multi-layer arteriole-scale human tissue-engineered blood vessels (TEBVs) by plastic compression. TEBVs maintain mechanical strength, vasoactivity, and nitric oxide (NO) production for at least 4 weeks. Perfusion of TEBVs at a physiological shear stress with enzyme-modified low-density-lipoprotein (eLDL) with or without TNFα promotes monocyte accumulation, reduces vasoactivity, alters NO production, which leads to endothelial cell activation, monocyte accumulation, foam cell formation and expression of pro-inflammatory cytokines. Removing eLDL leads to recovery of vasoactivity, but not loss of foam cells or recovery of permeability, while pretreatment with lovastatin or the P2Y11 inhibitor NF157 reduces monocyte accumulation and blocks foam cell formation. Perfusion with blood leads to increased monocyte adhesion. This atherosclerosis model can identify the role of drugs on specific vascular functions that cannot be assessed in vivo., Human microphysiological systems (MPS) have some advantages over animal models to study the mechanisms of disease. Here the authors use a tissue-engineered blood vessel MPS to create a model of early stage atherosclerosis and assess the effect of several drugs.

No consensus currently exists regarding the optimal approach for peritoneal dialysis catheter placement. We aimed to compare the outcomes of percutaneous and surgical peritoneal dialysis catheter placement.A systematic review of the literature was performed using the MEDLINE, Cochrane Library, and Scopus databases (end-of-search date: August 29th, 2020). We included studies comparing percutaneous (blind, under fluoroscopic/ultrasound guidance, and "half-perc") and surgical peritoneal dialysis catheter placement (open and laparoscopic) in terms of their infectious complications (peritonitis, tunnel/exit-site infections), mechanical complications (leakage, inflow/outflow obstruction, migration, hemorrhage, hernia, bowel perforation) and long-term outcomes (malfunction, removal, replacement, surgery required, and mortality).Thirty-four studies were identified, including thirty-two observational studies (twenty-six retrospective and six prospective) and two randomized controlled trials. Percutaneous placement was associated with significantly lower rates of tunnel/exit-site infection [relative risk (RR) 0.72, 95% confidence interval (CI) 0.56-0.91], catheter migration (RR 0.68, 95% CI 0.49, 0.95), and catheter removal (RR 0.73, 95% CI 0.60-0.88). The 2-week and 4-week rates of early tunnel/exit-site infection were also lower in the percutaneous group (RR 0.45, 95% CI 0.22-0.93 and RR 0.41, 95% CI 0.27-0.63, respectively). No statistically significant difference was observed regarding other outcomes, including catheter survival and mechanical complications.Overall, the quality of published literature on the field of peritoneal dialysis catheter placement is poor, with a small percentage of studies being randomized clinical trials. Percutaneous peritoneal dialysis catheter placement is a safe procedure and may result in fewer complications, such as tunnel/exit-site infections, and catheter migration, compared to surgical placement.PROSPERO CRD42020154951.

OBJECTIVESAortic insufficiency (AI) is common in patients with proximal aortic disease, but limited options exist to facilitate aortic valve repair (AVr) in this population. This study reports ‘real-world’ early results of AVr using newly FDA-approved trileaflet and bicuspid geometric annuloplasty rings for patients with AI undergoing proximal aortic repair (PAR) in a single referral centre.METHODSAll patients undergoing AVr with a rigid internal geometric annuloplasty ring (n = 47) in conjunction with PAR (ascending +/− root +/− arch) were included. Thirty-six patients underwent AVr with a trileaflet ring, and 11 patients underwent AVr with a bicuspid ring. The rings were implanted in the subannular position, and concomitant leaflet repair was performed if required for cusp prolapse identified after ring placement.RESULTSThe median age was 58 years [interquartile range (IQR) 46–70]. PAR included supracoronary ascending replacement in 26 (55%) patients and remodelling valve-sparing root replacement with selective sinus replacement in 20 (42%) patients. Arch replacement was performed in 38 (81%) patients, including hemi-arch in 34 patients and total arch in 4 patients. There was no 30-day/in-hospital mortality. Preoperative AI was 3–4+ in 37 (79%) patients. Forty-one (87%) patients had zero–trace AI on post-repair transoesophageal echocardiography, and 6 patients had 1+ AI. The median early post-repair mean gradient was 13 mmHg (IQR 5–20). Follow-up imaging was available in 32 (68%) patients at a median of 11 months (IQR 10–13) postsurgery. AI was ≤1+ in 97% of patients with 2+ AI in 1 patient. All patients were alive and free from aortic valve reintervention at last follow-up.CONCLUSIONSEarly results with geometric rigid internal ring annuloplasty for AVr in patients undergoing PAR appear promising and allow a standardized approach to repair with annular diameter reduction and cusp plication when needed. Longer-term follow-up will be required to ensure the durability of the procedure.

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.

Objectives This study sought to determine the durability of tricuspid valve repair (TVr) performed concurrently with left ventricular assist device (LVAD) implantation and its association with the development of late right heart failure (RHF). Background Surgical management of tricuspid regurgitation (TR) at the time of LVAD implantation is performed in an attempt to reduce the occurrence of postoperative RHF. Limited data exist regarding the durability of TVr in patients with LVAD as well as its impact on development of late RHF. Methods A retrospective review was conducted of consecutive adult patients who underwent durable LVAD implantation and concurrent TVr at the authors’ institution between 2009 and 2017. Late RHF was defined as readmission for HF requiring inotropic or diuretic therapy. TVr failure was defined as moderate or severe TR at any follow-up echocardiographic examination after LVAD implantation. Results A total of 156 patients underwent LVAD and concurrent TVr during the study. Of the total, 59 patients (37.8%) had a failed TVr. The mean duration of echocardiographic follow-up was 23 ± 22 months. Of the 146 patients who were discharged after the index hospitalization, 53 patients (36.3%) developed late RHF. Multivariate Cox proportional hazard analysis demonstrated that TVr failure was an independent predictor of late RHF development (hazard ratio: 2.62; 95% confidence interval: 1.38 to 4.96; p = 0.003). Conclusions Failure of TVr in this cohort occurred at a significant rate. Failure of TVr is an independent risk factor for development of late RHF. Future studies should investigate strategies to reduce recurrence of significant TR.

Objective The impact of new-onset postoperative atrial fibrillation (POAF) following coronary artery bypass grafting (CABG) surgery on long-term clinical outcomes and costs is not known. This subanalysis of the Veterans Affairs “Randomized On/Off Bypass Follow-up Study” compared 5-year outcomes and costs between patients with and without POAF. Methods Of the 2203 veterans in the study, 100 with pre-CABG atrial fibrillation (93) or missing data (7) were excluded (4.8%). Unadjusted and risk-adjusted outcomes were compared between new-onset POAF (n = 551) and patients without POAF (n = 1552). Five-year clinical outcomes included mortality, major adverse cardiovascular events (MACE, comprising mortality, repeat revascularization, and myocardial infarction), MACE subcomponents, stroke, and costs. A stringent P value of ≤.01 was required to identify statistical significance. Results Patients with POAF were older and had more complex comorbidities. Unadjusted 5-year all-cause mortality was 16.3% POAF versus 11.9% no-POAF, P = .008. Unadjusted cardiac-mortality was 7.4% versus 4.8%, P = .022. There were no differences between groups in any other unadjusted outcomes including MACE or stroke. After risk adjustment, there were no significant differences between groups in 5-year all-cause mortality (POAF odds ratio, 1.19; 99% confidence interval, 0.81-1.75) or cardiac mortality (odds ratio, 1.51, 99% confidence interval, 0.88-2.60). Adjusted first-year post-CABG costs were $15,300 greater for patients with POAF, but 2- through 5-year costs were similar. Conclusions No 5-year risk-adjusted outcome differences were found between patients with and without POAF after CABG. Although first-year costs were greater in patients with POAF, this difference did not persist in subsequent years.

The aim of this study was to assess the real-world impact of transcatheter mitral valve repair (TMVR) on hospitalizations and Medicare costs pre- versus post-TMVR.TMVR is effective in degenerative mitral regurgitation (MR) and appropriately selected patients with functional MR with high surgical risk.Patients undergoing TMVR in the Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry from 2013 to 2018 were linked to Medicare claims data. Rates of hospitalizations, hospitalized days, and Medicare costs were compared 1-year pre-TMVR to 1-year post-TMVR.Across 246 sites, 4,970 patients with a median age of 83 years (interquartile range: 77 to 87 years) were analyzed. The TMVR indication was degenerative MR in 77.5% and functional MR in 16.7%. From pre- to post-TMVR, heart failure (HF) hospitalization rates (479 vs. 370 hospitalizations/1,000 person-years; rate ratio [RR]: 0.77) and cardiovascular hospitalizations (838 vs. 632; RR: 0.75) decreased significantly (p 0.001 for all). Similarly, the rates of hospitalized days decreased for HF and cardiovascular causes (p 0.05 for all). Following TMVR, the odds of having no Medicare costs for HF hospitalizations increased (69% vs. 79%; odds ratio: 1.67; p 0.001). However, the average total Medicare costs per day alive among patients with any HF hospitalizations after TMVR increased significantly (p 0.001). The HF hospitalization rates decreased for patients with functional MR (683 vs. 502; RR: 0.74) and those with degenerative MR (431 vs. 337; RR: 0.78) (p 0.001).TMVR is associated with a decrease in cardiovascular and HF hospitalizations and a greater likelihood of having no HF Medicare costs in the year after TMVR, regardless of MR etiology. Further work is necessary to elucidate the reasons for increased costs among patients with HF hospitalizations post-TMVR.

The need for biventricular support poses significant challenges for patients who require a mechanical bridge to transplantation. Recent improvements in ventricular assist device (VAD) technology has made possible the use of two centrifugal flow VADs as a total artificial heart (TAH) replacement. The HeartMate 3 (HM3; [Full MagLev, Abbott Laboratories, Chicago, Illinois]) was recently approved as a destination therapy; this VAD has a number of unique advantages that allow for its off-label use for biventricular support. Here, we describe the use of two HM3s as a TAH in a patient as a bridge to transplant.

BACKGROUND Lung transplantation offers a survival benefit for patients with end-stage lung disease. When suitable donors are identified, centers must accept or decline the offer for a matched candidate on their waitlist. The degree to which variability in per-center offer acceptance practices impacts candidate survival is not established. The purpose of this study was to determine the degree of variability in per-center rates of lung transplantation offer acceptance and to ascertain the associated contribution to observed differences in per-center waitlist mortality. METHODS We performed a retrospective cohort study of candidates waitlisted for lung transplantation in the US using registry data. Logistic regression was fit to assess the relationship of offer acceptance with donor, candidate, and geographic factors. Listing center was evaluated as a fixed effect to determine the adjusted per-center acceptance rate. Competing risks analysis employing the Fine-Gray model was undertaken to establish the relationship between adjusted per-center acceptance and waitlist mortality. RESULTS Of 15,847 unique organ offers, 4,735 (29.9%) were accepted for first-ranked candidates. After adjustment for important covariates, transplant centers varied markedly in acceptance rate (9%–67%). Higher cumulative incidence of 1-year waitlist mortality was associated with lower acceptance rate. For every 10% increase in adjusted center acceptance rate, the risk of waitlist mortality decreased by 36.3% (sub-distribution hazard ratio 0.637; 95% confidence interval 0.592–0.685). CONCLUSIONS Variability in center-level behavior represents a modifiable risk factor for waitlist mortality in lung transplantation. Further intervention is needed to standardize center-level offer acceptance practices and minimize waitlist mortality.

Background: Studies of the relationship between patient self-reported angina symptoms using the Seattle Angina Questionnaire (SAQ) and angiographic findings after coronary artery bypass grafting surgery (CABG) are lacking. Nested within a randomized controlled trial, this prospective observational cohort comparison study aimed to assess which clinical characteristics and angiographic findings are associated with self-reported angina 1 year after CABG. Methods and Results: Patients from the ROOBY trial (Randomized On/Off Bypass) with protocol-specified 1-year post-CABG coronary angiography and SAQ assessments were included (n=1258). Patients reporting no angina (62.3%) within 4 weeks before the 1-year post-CABG study visit on the SAQ angina frequency domain were compared with patients reporting angina (37.7%). Multivariable modeling identified clinical variables and angiographic findings associated with angina. Sequential univariate and multivariable modeling found the following demographic and clinical factors were associated with angina after CABG: younger age, worse preoperative SAQ angina frequency score, smoking, diabetes mellitus, and pre-CABG depression. The only 1-year angiographic finding significantly associated with angina was incomplete revascularization of the left anterior descending (LAD) territory. Graft occlusions, incomplete revascularization of non-LAD territories, and ≥70% lesions in nonrevascularized native coronary arteries were not correlated with the presence or absence of angina. Further, only 30.6% of subjects reporting angina at 1 year had a residual major coronary artery stenosis of ≥70%. Conclusions: Self-reported angina 1 year after CABG is associated with younger age, worse baseline SAQ angina frequency score, smoking, diabetes mellitus, and depression. The only angiographic finding associated with angina was a poorly revascularized LAD territory. These results may help guide physicians when counseling patients on expected improvements in angina symptoms and in making decisions regarding the need for coronary angiography after CABG. Whether intensive treatment of these comorbidities improves post-CABG angina symptoms requires further study. Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT00032630.

The innate immune system is a critical regulator of the adaptive immune responses that lead to allograft rejection. It is increasingly recognized that endogenous molecules released from tissue injury and cell death are potent activators of innate immunity. Mitochondria, ancestrally related to bacteria, possess an array of endogenous innate immune-activating molecules. We have recently demonstrated that extracellular mitochondria are abundant in the circulation of deceased organ donors and that their presence correlates with early allograft dysfunction. Here we demonstrate the ability of mitochondria to activate endothelial cells (ECs), the initial barrier between a solid organ allograft and its host. We find that mitochondria exposure leads to the upregulation of EC adhesion molecules and their production of inflammatory cytokines and chemokines. Additionally, mitochondrial exposure causes dendritic cells to upregulate costimulatory molecules. Infusion of isolated mitochondria into heart donors leads to significant increase in allograft rejection in a murine heterotopic heart transplantation model. Finally, co-incubation of human peripheral blood mononuclear cells with mitochondria-treated ECs results in increased numbers of effector (IFN-γ+ , TNF-α+ ) CD8+ T cells. These data indicate that circulating extracellular mitochondria in deceased organ donors may directly activate allograft ECs and promote graft rejection in transplant recipients.

Background Several studies have shown comparable early efficacy of mechanochemical ablation to endothermal techniques. The goal of this report was to show if early efficacy is maintained at 24 months. Methods This was a two-year analysis on the efficacy of mechanochemical ablation in patients with symptomatic C2 or more advanced chronic venous disease. Patients with reflux in the great saphenous vein involving the sapheno-femoral junction and no previous venous interventions were included. Demographic information, clinical, and procedural data were collected. The occlusion rate of treated veins was assessed with duplex ultrasound. Patient clinical improvement was assessed by Clinical-Etiology-Anatomy-Pathophysiology (CEAP) class and venous clinical severity score. Results Of the initial 126 patients, there were 65 patients with 24 month follow-up. Of these 65 patients, 70% were female, with a mean age of 70 ± 14 years and an average body mass index (BMI) of BMI of 30.5 ± 6. The mean great saphenous vein diameter in the upper thigh was 7.6 mm and the mean treatment length was 39 cm. Adjunctive treatment of the varicosities was performed in 14% of patients during the procedure. Closure rates were 100% at one week, 98% at three months, 95% at 12 months, and 92% at 24 months. There was one patient with complete and four with partial recanalization ranging from 7 to 12 cm (mean length 9 cm). There was significant improvement in CEAP and venous clinical severity score (P Conclusion Early high occlusion rate with mechanochemical ablation is associated with significant clinical improvement which is maintained at 24 months, making it a very good option for the treatment of great saphenous vein incompetence.

Background Closed-suction drains, implants, and acellular dermal matrix (ADM) are routinely used in tissue expander-based immediate breast reconstruction (TE-IBR). Each of these factors is thought to increase the potential for surgical site infection (SSI). Although CDC guidelines recommend only 24 hours of antibiotic prophylaxis after TE-IBR, current clinical practices vary significantly. This study evaluated the difference in SSI between 2 different prophylactic antibiotic durations. Study Design A noninferiority randomized controlled trial was designed in which TE-IBR patients received antibiotics either 24 hours postoperatively or until drain removal. The primary outcome was SSI, as defined by CDC criteria. Operative and postoperative protocols were standardized. Secondary endpoints included clinical outcomes up to 1 year and all implant loss, or reoperation. Results There were 112 TE-IBR patients (180 breasts) using ADM who were randomized into 2 study arms, with 62 patients in the 24-hour group and 50 in the extended group. Surgical site infection was diagnosed in 12 patients in the 24-hour group and 11 in the extended group (19.4% vs 22.0%, p = 0.82). The extended group had 7 patients who required IV antibiotics and an overall implant loss in 7 patients (14.0%). The 24-hour group had 4 patients who required IV antibiotics, with 3 requiring removal (4.8%). Patients with diabetes, postoperative seroma, or wound dehiscence were all more likely to develop SSI (p Conclusions In a randomized controlled noninferiority trial, 24 hours of antibiotics is equivalent to extended oral antibiotics for SSI in TE-IBR patients. Additional multicenter trials will further assess this important aspect of TE-IBR postoperative care.

An increasing number of end-stage heart failure patients are supported with left ventricular assist device (LVAD) implantation and must be maintained on consistent anticoagulation. These patients are experiencing prolonged survival and, in some, there is development of new biliary disease. However, safety and outcomes of this procedure in this unique patient group is not well reported.This was a retrospective single-center review. All adult patients supported on an implanted, continuous flow LVAD from 2007 to 2016 were screened. Baseline characteristics, laboratory values, and operative details were collected through retrospective chart review and an institutional LVAD registry.Of the 798 patients screened, 5 (0.63%) underwent laparoscopic cholecystectomy after LVAD implantation. In 4 patients (80%), the indication for surgery was symptomatic cholelithiasis and 1 patient (20%) had symptomatic acalculous cholecystitis. The average time from LVAD implantation to laparoscopic cholecystectomy was 254 ± 158 days. Average (corrected) preoperative international normalized ratio (INR) was 1.34 ± 0.30. Average preoperative hemoglobin was 11.28 ± 2.41 g/dL. All patients were on warfarin preoperatively and admitted before their operations for bridging with a heparin drip. Average postoperative change in hemoglobin was -1.16 ± 1.97 g/dL. The only major postoperative complication in this cohort was the development of an abdominal wall hematoma in 1 patient requiring operative evacuation. The average length of stay was 13.2 ± 4.6 days. Three patients (60%) took an average of 12 days to reach therapeutic INR.Laparoscopic cholecystectomies can be performed safely in LVAD patients. Prolonged hospital stay is mainly owing to time required to reach a therapeutic INR postoperatively.II, prognostic.

Acute aortic syndromes are a distinct group of pathologies involving the wall of the aorta that present acutely and can be potentially fatal unless treated in a timely fashion. The syndrome is dominated by aortic dissections, which comprise ≥95% of all such presentations. Those involving the ascending aorta are particularly lethal and require specific and early surgical treatment compared to dissections involving other parts of the aorta. The surgical repair of an ascending aortic dissection presents multiple challenges to the anesthesiologist. Thoughtful management throughout the perioperative period is critical for minimizing the significant morbidity and mortality associated with this condition. In this narrative review, we provide an overview of the perioperative management of patients presenting for the surgical repair of an ascending aortic dissection. Preoperative discussion focuses on assessment, hemodynamic management, and risk stratification. The intraoperative section includes an overview of anesthetic management, transesophageal echocardiographic assessment, and coagulopathy, as well as surgical considerations that may influence anesthetic management.

Mechanical circulatory support (MCS) has been introduced as a viable alternative to heart transplantation primarily through the use of intracorporeal ventricular assist devices (VADs) for support of the left ventricle. However, certain clinical scenarios warrant biventricular mechanical support. One strategy for some patients is the excision of both ventricles and the implantation of two VAD pumps as a total artificial heart (TAH). This has recently been made possible by the improvements in device design and the small profile of centrifugal devices. This TAH approach remains experimental with many important challenges such as the device settings to balance the right and left circulation, the orientation of the devices and the outflow graft with their influence on hemolysis and stability, and the outcome of chronic support using such an orientation. This protocol aims to provide a reproducible approach for total artificial heart replacement with two intracorporeal centrifugal VADs in a cow model.

BACKGROUND Patients with end-stage heart failure on left ventricular assist devices (LVADs) are predisposed to a high incidence of stroke. Preoperative factors associated with increased stroke risk are poorly understood. METHODS We performed a single-center retrospective review of all patients from 2009 to 2014 in whom a rotary flow LVAD was implanted. All patients with symptoms of a cerebrovascular event underwent a non-contrast head computed tomography scan. Logistic regression was used to determine factors associated with stroke both on univariate and multivariable analysis. RESULTS A total of 390 patients were retrospectively analyzed and of those 61 (15.6%) had a stroke at an average follow-up of 3.5 ± 1.6 years. The majority were male (72%) and were treated a priori as destination therapy (73%). The proportion of patient receiving a centrifugal flow pump was 23% compared to 77% receiving an axial flow pump. For those patients who experienced a stroke and then died, the average time from stroke to death was 158 ± 296 days. Of the 61 patients who had a stroke, 38 (62%) died (P

Background Right heart failure occurs in 9% to 44% of left ventricular assist device (LVAD) implants, of which less than 10% require right ventricular assist device (RVAD) support either concurrently with the LVAD or staged, as a delayed procedure. We have reported our outcomes based on whether the RVAD was placed concurrently or staged. Methods Clinical data were obtained from the Duke University Medical Center database. The study focused on all consecutive adult patients who received continuous flow LVAD with either concurrent or staged (within 7 days) extracorporeal, temporary RVAD, between October 2007 and October 2017. Adverse event profiles and ability to wean from RVAD were compared between these two groups. Results Overall, 43 patients required an extracorporeal RVAD; 67% (n = 29) were implanted concurrently and 33% (n = 14) were implanted as staged after the LVAD. In all, 67% of patients (n = 29) could be weaned to an isolated LVAD. The 30-day, inhospital, and total mortality rates for our cohort were 14%, 28%, and 51% respectively. The mortality rate in the study period for the staged implants was 71% versus 45% for the concurrent implants (p = 0.101). In addition, staged RVAD implantation carried a significantly higher rate of postoperative renal failure (64% versus 28%, p = 0.044). Conclusions There was a low incidence of need for RVAD in our cohort. The majority could be weaned to an isolated LVAD. Morbidity and mortality rates of this mode of biventricular support remain high. Early institution of RVAD support was associated with reduced rates of post-LVAD renal failure rates.

Tricuspid valve regurgitation (TR) is a common finding immediately after cardiac transplantation. However, there is a scarcity of data regarding its implication if left untreated on long-term outcomes and the role of early surgical repair.We retrospectively reviewed the Duke University Medical Center transplant database from January 2000 to June 2012 and identified 542 patients who underwent orthotropic heart transplantation. Patients were excluded if they underwent surgical repair for TR during the transplant or if the transplant was part of a multiorgan transplant or redo heart transplantation. TR was assessed intraoperatively after weaning from cardiopulmonary bypass. Independent variables were grade of TR and changes in TR grade during follow-up. TR grades were classified as insignificant (none or mild) versus significant (moderate or severe). Survival and need for posttransplant valve repair during follow-up were assessed.Significant TR was detected in 114 patients (21%) after weaning from cardiopulmonary bypass, with no significant difference in preoperative recipient pulmonary vascular resistance. Significant TR was associated with increased maximum postoperative plasma creatinine (median [interquartile range], 2.2 [1.5 to 3.2] mg/dL vs 1.8 [1.4 to 2.6] mg/dL, p = 0.008), prolonged postoperative stay (median [interquartile range], 12 [9 to 21] days vs 10 [8 to 14] days; p0.001), and decreased adjusted survival. Significant TR regressed to insignificant in 91% of recipients by 1 year after transplant. Six recipients (1%) who had significant TR after cardiopulmonary bypass underwent delayed tricuspid valve repair for significant TR during follow-up.Significant TR is a common finding immediately after transplant and is associated with early morbidity and reduced adjusted survival. Most significant TR resolves by 1 year after transplant. Optimal algorithms for follow-up and treatment of significant TR after heart transplantation need to be defined.

Background For diabetic patients who require coronary artery bypass graft (CABG) operation, controversy persists whether an off-pump or an on-pump approach may be advantageous. This US-based, multicenter, randomized, controlled trial, Department of Veterans Affairs Randomization On versus Off Bypass Follow-up Study, compared diabetic patients’ 5-year clinical outcomes for off-pump versus on-pump procedures. Methods From 2002 to 2008, 835 medically treated (ie, oral hypoglycemic agent or insulin) diabetic patients underwent either off-pump (n = 402) or on-pump (n = 433) CABG. Five-year primary end points included all-cause death and major adverse cardiovascular events (MACE; composite included all-cause death, myocardial infarction, or repeat revascularization). Secondary 5-year end points included cardiac death and MACE-related components. With baseline risk factors balanced, outcomes were evaluated by using a p value less than or equal to 0.01; nonsignificant trends were reported for p values greater than 0.01 and less than or equal to 0.15. Results Five-year all-cause death rates were 20.2% off pump versus 14.1% on pump (p = 0.0198). No differences were seen in MACE (32.6% off-pump approach versus 28.6% on-pump approach, p = 0.216), repeat revascularization (12.4% off-pump approach versus 11.8% on-pump approach, p = 0.770), and nonfatal myocardial infarction (12.7% off-pump approach versus 10.4% on-pump approach, p = 0.299). Cardiac death trended worse with off-pump CABG (9.0%) than with on-pump CABG (6.25%, p = 0.137). Sensitivity analyses that removed conversions confirmed these findings. Conclusions With a 6.1% absolute difference, a strong trend toward improved 5-year survival was observed with on-pump CABG for medically treated diabetic patients. No off-pump advantage was found for any 5-year end points. A future clinical trial now appears warranted to rigorously compare off-pump versus on-pump longer term outcomes for diabetic patients.

BACKGROUND The optimal methodology to identify cardiac versus non-cardiac cause of death following cardiac surgery has not been determined. METHODS The Randomized On/Off Bypass Trial was a multicenter, randomized, controlled clinical trial of 2203 patients (February 2002-May 2008) comparing 1-year cardiac outcomes between off-pump and on-pump bypass surgery. In 2013, the Veterans Affairs (VA) Cooperative Studies Program funded a follow-up study to assess 5-year outcomes including mortality. Deaths were identified and confirmed using the National Death Index (NDI), VA Vital Status file, and medical records. An Endpoints Committee (EC) reviewed patient medical records and classified each cause of death as cardiac, non-cardiac, or unknown. Using pre-determined ICD-10 codes, NDI death certificates were independently used to classify deaths as cardiac or non-cardiac. Cause of death was compared between the NDI and EC classifications and concordance measured, using Kappa statistics. RESULTS Of the 297 5-year deaths identified by the NDI and/or VA vital status file and confirmed by the EC, 219 had adequate patient records for EC cause of death determination. The EC adjudicated 141 of these deaths as non-cardiac and 78 as cardiac, while the NDI classified 150 as non-cardiac and 69 as cardiac; agreement was 77.6% (kappa 0.500; P

Since 2010, 460+ hospital mergers have occurred in the United States, rerouting historical coronary artery bypass graft (CABG) referral patterns. The goals of this study were: (1) to compare risk-adjusted CABG outcomes between single-center versus multicenter surgeons; and (2) for multicenter surgeons, to evaluate the risk-adjusted outcomes between their home (primary) versus satellite (secondary) hospitals.Using The Society of Thoracic Surgeons Adult Cardiac Surgery Database, nonemergent, first-time CABG procedures (n = 543,403) performed in the US between 2011 and 2014 were extracted across 1,120 centers and for 2,676 surgeons. Surgeons were classified as multicenter if they performed operations at two separate hospitals for ≥ 2 consecutive quarters; their home hospital was identified as their highest volume center. Observed-to-expected outcome ratios were reported using approved multivariable risk models for 30-day operative mortality and major morbidity.Of 2,676 cardiac surgeons, 668 (25.0%) operated at multiple centers. The observed-to-expected mortality ratios were 1.06 (95% confidence interval [CI], 1.01 to 1.12) and 0.97 (95% CI, 0.94 to 1.00) for multi- and single-center surgeons (p0.001). For multicenter surgeons, the observed-to-expected mortality ratios were 1.17 (95% CI, 1.09 to 1.27) versus 1.01 (95% CI, 0.96 to 1.07), p 0.001, for their satellite versus home facilities, respectively.Single-center surgeons performing CABG had lower risk-adjusted outcome rates compared with multicenter surgeons, who performed better at their home versus satellite hospitals. To improve future quality of care, surgeons, health care networks, and health policy makers should now more closely scrutinize their single versus multicenter performance.

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.

This study was performed to determine impact of open and hand-assisted colorectal resection on surgical site infection (SSI) rates. National Surgical Quality Improvement Project data from 2006 to 2008 were supplemented with an institutional review board-approved chart review. Primary endpoint was SSI rates defined by the Centers for Disease Control National Nosocomial Infections Surveillance system and classified as superficial, deep incisional, and organ space. Inclusion criteria were elective or emergency open or hand-assisted colorectal resections. Wounds were classified as clean-contaminated, contaminated, or dirty-infected. Patients were not included if they underwent laparoscopic colorectal resection, small bowel resection, or stoma creation. Two hundred and forty-five consecutive patients were included over a 29-month period. One hundred and ninety-five open and 50 hand-assisted patients were comparable for gender, body mass index, ethnicity, tobacco addiction, steroid use, type of colorectal resection, operating time, and method of wound closure. Differences in ASA class, wound classification, and preexisting comorbidities resolved when 80 open and 5 hand-assisted patients who underwent emergency resections were excluded from analysis. Rate of stoma creation remained higher in open patients even after excluding emergency cases (p

Studies investigating lipid-lowering medication (LLM) use and LDL levels in coronary artery bypass grafting patients are limited.The Veterans Affairs Randomized On/Off Bypass Trial's patient records were analyzed for LLM use and 1-year LDL levels. Mortality, acute MI (AMI), and repeat revascularization rates were compared at 1 year between patients with and without LLM at discharge. In addition, AMI, repeat revascularization, and graft patency were compared between patients that did and did not achieve a 1-year LDL target level of100 mg/dL.The LLM data were available for 86.4% (1,904 of 2,203) of patients. Rates of LLM use were 83.4% (1,316 of 1,577) at discharge and 90.0% (1,713 of 1,904) at 1 year. Patients discharged after coronary artery bypass grafting on LLMs had a significantly lower 1-year mortality rate (1.9% vs 5.4%; p0.01) than those not discharged on LLM, and 1-year AMI and repeat revascularization rates were not significantly different. Of the patients with 1-year LDL measurements, 69.4% (1,200 of 1,729) achieved an LDL target level of100 mg/dL. No differences were seen in AMI, revascularization, or graft occlusion rates between patients who achieved target LDL levels and those who did not.Rates of LLM use among veterans post-coronary artery bypass grafting are high. Discharge on LLM might be associated with improved intermediate-term survival. Patients who achieved an LDL target of100 mg/dL at 1-year did not experience improved 1-year clinical outcomes or graft patency. Longer-term follow-up might reveal differences in cardiac outcomes related to achievement of target LDL levels.