Improved Outcomes in Severe Primary Graft Dysfunction After Heart Transplantation Following Donation After Circulatory Death Compared With Donation After Brain Death.

BACKGROUND: Primary graft dysfunction (PGD), the leading cause of early mortality after heart transplantation, is more common following donation after circulatory death (DCD) than donation after brain death (DBD). We conducted a single-center, retrospective cohort study to compare the incidence, severity and outcomes of patients experiencing PGD after DCD compared to DBD heart transplantation. METHODS AND RESULTS: Medical records were reviewed for all adult heart transplant recipients at our institution between March 2016 and December 2021. PGD was diagnosed within 24 hours after transplant according to modified International Society for Heart and Lung Transplant criteria. A total of 459 patients underwent isolated heart transplantation during the study period, 65 (14%) following DCD and 394 (86%) following DBD. The incidence of moderate or severe PGD in DCD and DBD recipients was 34% and 23%, respectively (P = 0.070). DCD recipients were more likely to experience severe biventricular PGD than DBD recipients (19% vs 7.4%; P = 0.004). Among patients with severe PGD, DCD recipients experienced shorter median (Q1, Q3) duration of post-transplant mechanical circulatory support (6 [4, 7] vs 9 [5, 14] days; P = 0.039), shorter median post-transplant hospital length of stay (17 [15, 29] vs 52 [26, 83] days; P = 0.004), and similar 60-day survival rates (100% [95% CI: 76.8%-100%] vs 80.0% [63.1%-91.6%]; P = 0.17) and overall survival (log-rank; P = 0.078) compared with DBD recipients. CONCLUSIONS: DCD heart transplant recipients were more likely to experience severe, biventricular PGD than DBD recipients. Despite this, DCD recipients with severe PGD spent fewer days on mechanical circulatory support and in the hospital than similar DBD patients. These findings suggest that patterns of graft dysfunction and recovery may differ between donor types, and they support the expansion of the heart-donor pool with DCD.

The outcome of mitral repair for degenerative versus ischemic mitral regurgitation using a single complete ring.

BACKGROUND: 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. METHODS: 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. RESULTS: 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). CONCLUSIONS: 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.

Health-related quality of life impacts upon 5-year survival after coronary artery bypass surgery.

BACKGROUND: 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. METHODS: 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). RESULTS: 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. CONCLUSIONS: 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.

Five-Year Outcomes after On-Pump and Off-Pump Coronary-Artery Bypass.

BACKGROUND: Coronary-artery bypass grafting (CABG) surgery may be performed either with cardiopulmonary bypass (on pump) or without cardiopulmonary bypass (off pump). We report the 5-year clinical outcomes in patients who had been included in the Veterans Affairs trial of on-pump versus off-pump CABG. METHODS: From February 2002 through June 2007, we randomly assigned 2203 patients at 18 medical centers to undergo either on-pump or off-pump CABG, with 1-year assessments completed by May 2008. The two primary 5-year outcomes were death from any cause and a composite outcome of major adverse cardiovascular events, defined as death from any cause, repeat revascularization (CABG or percutaneous coronary intervention), or nonfatal myocardial infarction. Secondary 5-year outcomes included death from cardiac causes, repeat revascularization, and nonfatal myocardial infarction. Primary outcomes were assessed at a P value of 0.05 or less, and secondary outcomes at a P value of 0.01 or less. RESULTS: The rate of death at 5 years was 15.2% in the off-pump group versus 11.9% in the on-pump group (relative risk, 1.28; 95% confidence interval [CI], 1.03 to 1.58; P=0.02). The rate of major adverse cardiovascular events at 5 years was 31.0% in the off-pump group versus 27.1% in the on-pump group (relative risk, 1.14; 95% CI, 1.00 to 1.30; P=0.046). For the 5-year secondary outcomes, no significant differences were observed: for nonfatal myocardial infarction, the rate was 12.1% in the off-pump group and 9.6% in the on-pump group (P=0.05); for death from cardiac causes, the rate was 6.3% and 5.3%, respectively (P=0.29); for repeat revascularization, the rate was 13.1% and 11.9%, respectively (P=0.39); and for repeat CABG, the rate was 1.4% and 0.5%, respectively (P=0.02). CONCLUSIONS: In this randomized trial, off-pump CABG led to lower rates of 5-year survival and event-free survival than on-pump CABG. (Funded by the Department of Veterans Affairs Office of Research and Development Cooperative Studies Program and others; ROOBY-FS ClinicalTrials.gov number, NCT01924442 .).

Surgical infection prophylaxis prior to left ventricular assist device implantation: A survey of clinical practice.

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.

Stroke risk following implantation of current generation centrifugal flow left ventricular assist devices.

BACKGROUND AND AIM: 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. METHODS: Exclusion criteria were age <18 and preoperative ECMO. The primary endpoint was stroke-free survival. Stroke was defined as new neurological deficits persisting >24 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. RESULTS: 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). CONCLUSIONS: Different LVAD models appear to be associated with significantly different stroke risks.

Cloud Computing for COVID-19: Lessons Learned From Massively Parallel Models of Ventilator Splitting.

A patient-specific airflow simulation was developed to help address the pressing need for an expansion of the ventilator capacity in response to the COVID-19 pandemic. The computational model provides guidance regarding how to split a ventilator between two or more patients with differing respiratory physiologies. To address the need for fast deployment and identification of optimal patient-specific tuning, there was a need to simulate hundreds of millions of different clinically relevant parameter combinations in a short time. This task, driven by the dire circumstances, presented unique computational and research challenges. We present here the guiding principles and lessons learned as to how a large-scale and robust cloud instance was designed and deployed within 24 hours and 800 000 compute hours were utilized in a 72-hour period. We discuss the design choices to enable a quick turnaround of the model, execute the simulation, and create an intuitive and interactive interface.

Circulating mitochondria in organ donors promote allograft rejection.

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.

Outcomes of carotid-subclavian bypass performed in the setting of thoracic endovascular aortic repair.

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.

Controlling axillary intra-aortic balloon pump inflation is a viable option for turning an acute heart failure patient into a chronic one.

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.

Preoperative factors associated with worsening in health-related quality of life following coronary artery bypass grafting in the Randomized On/Off Bypass (ROOBY) trial.

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.

Extracellular Mitochondrial DNA and N-Formyl Peptides in Trauma and Critical Illness: A Systematic Review.

OBJECTIVES: Extracellular mitochondrial DNA and N-formyl peptides released following tissue damage may contribute to systemic inflammation through stimulation of the innate immune system. In this review, we evaluate existing in vivo human data regarding a role for mitochondrial DNA and N-formyl peptides in producing systemic inflammation in trauma and critical illness, investigate the utility of these molecules in risk prediction and clinical decision support, and provide suggestions for standardization of future research. DATA SOURCES: PubMed, Embase (1971-2017). STUDY SELECTION: Studies measuring extracellular mitochondrial DNA and/or N-formyl peptides in acutely ill patients. DATA EXTRACTION: Fifty-four studies were analyzed. Data extracted included article characteristics, methods, results, and performance in clinical prediction. DATA SYNTHESIS: The most common patient types investigated were trauma (19 studies) and sepsis (eight). In studies comparing patient mitochondrial DNA or N-formyl peptide levels to healthy controls, 38 (90.5%) reported significantly elevated mitochondrial DNA levels in patients at first reported time point, as did the one study making this comparison for N-formyl peptides. Nine studies (81.8%) reported significantly elevated plasma/serum mitochondrial DNA levels in at least one time point in patients who developed inflammatory complications of their primary pathology compared with patients without inflammatory complications. For the ability of mitochondrial DNA to predict complications or outcomes, the area under the curve was 0.7 or greater in 84.6% of receiver operating characteristic curves, and 92.9% of odds, adjusted odds, risk, and hazard ratios were statistically significant. CONCLUSIONS: Extracellular mitochondrial DNA levels are elevated early in patients' hospital courses in many acute illnesses and are higher in patients who develop inflammatory complications. Elevated mitochondrial DNA levels may be clinically useful in risk prediction and clinical decision support systems. Further research is needed to determine the role of extracellular N-formyl peptides in systemic inflammation and their possible clinical utility.

The Perioperative Management of Ascending Aortic Dissection.

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.

Management of Patients With Left Ventricular Assist Devices Requiring Teeth Extraction: Is Halting Anticoagulation Appropriate?

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.

Risk factors for stroke on left ventricular assist devices.

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 < 0.001 compared to death rate without a stroke). On Cox regression analysis, a history of cerebrovascular accident (CVA), hyperlipidemia, and history of venous thromboembolism (VTE) were independently associated with stroke while on LVAD support. CONCLUSION: Postoperative stroke after LVAD implantation was associated with higher mortality. A history of previous CVA, VTE, and hyperlipidemia were independently associated with stroke while on LVAD support.

Concordance between administrative data and clinical review for mortality in the randomized on/off bypass follow-up study (ROOBY-FS).

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 < 0.001). CONCLUSIONS: Since concordance between EC and NDI cause of death classifications was only moderate, caution should be exercised in relying exclusively on NDI data to determine cause of death. A hybrid approach, integrating multiple information sources, may provide the most accurate approach to classifying cause of death.

Simulated transanal NOTES sigmoidectomy training improves the responsiveness of surgical endoscopists.

BACKGROUND: There is no evidence demonstrating the feasibility of colorectal natural orifice transluminal endoscopic surgery (NOTES) resection with currently available endoscopic instrumentation. OBJECTIVE: This study aimed to evaluate the responsiveness of surgical endoscopists to simulated transanal NOTES sigmoidectomy training. DESIGN: Participants were trained in simulated NOTES sigmoidectomy by using disposable abdominal trays with tattooed sigmoid cancer in a hybrid simulator. SETTING: Endoscopy simulation laboratory in a university hospital. INTERVENTIONS: NOTES sigmoidectomy included 8 steps performed transanally with 2 colonoscopes, endoscopic scissors, and clip applier: (1) colonoscopic viscerotomy with a balloon; (2) retroperitoneal dissection; (3) left ureter identification, inferior mesenteric vessels division; (4) colonoscopy; (5) splenic flexure mobilization; (6) left side of the colon/rectal mobilization; (7) transanal specimen transection; (8) extracorporeal colorectal anastomosis. MAIN OUTCOME MEASUREMENTS: Responsiveness was defined as a change in performance over time and assessed comparing baseline testing with unmentored final testing. Content-valid measures included the length of the specimen, the distance of the anastomosis from the anal verge, and the proximal and distal resection margins and operating time (minutes). RESULTS: Four participants performed 21 resections. Tumor distance from the anal verge was 29.2 cm (range 26-2.5 cm). Operating time overall (127.5 vs 74 minutes, P = .068), viscerotomy (17.5 vs 9 minutes, P = .197), colonoscopy (4.5 vs 3.5 minutes, P = .655), flexure mobilization (19.5 vs 10 minutes, P = .144), colon mobilization (20 vs 14.5 minutes, P = .461), specimen extraction (9.5 vs 8.5 minutes, P = .465), and anastomosis (14 vs 11 minutes, P = .715) times improved. LIMITATIONS: Ceiling effects because of fixed anatomy. CONCLUSIONS: Simulated NOTES sigmoidectomy training affected responsiveness of surgical endoscopists with a 42% reduction in operating time.

Outcomes of Leaflet Resection vs Chordal Replacement for Degenerative Mitral Regurgitation.

BACKGROUND: Debate persists regarding the outcomes of leaflet resection (RESECT) vs chordal replacement (CHORD) for degenerative mitral regurgitation. Our aim was to compare early and late outcomes of the RESECT vs CHORD techniques for degenerative mitral regurgitation. METHODS: A total of 1066 consecutive patients undergoing mitral repair for degenerative regurgitation with the RESECT vs CHORD techniques were evaluated from a prospectively maintained database. Propensity score matching was used to compare outcomes in RESECT vs CHORD repairs. RESULTS: Patients who underwent CHORD had later operative dates, more flail leaflet, and more anterior leaflet disease. With the switch to predominant use of the CHORD technique in 2010, the percentage of repair for all degenerative valves improved significantly from 83% to 91% (P = .002). A total of 467 patients were matched for baseline characteristics. Patients in the CHORD group had larger rings (34 mm vs 32 mm; P < .001) and greater use of an Alfieri stitch (66% vs 22%; P < .001) in matched patients. The 10-year survival was similar for matched patients (RESECT vs CHORD, 86% ± 3% vs 84% ± 4%; P = .5).Patients in the RESECT group had a lower 10-year cumulative incidence of mitral reoperation (RESECT vs CHORD, 1% ± 1% vs 8% ± 3%; P = .002) and severe mitral regurgitation (RESECT vs CHORD, 1% ± 1% vs 9% ± 5%; P = .05) compared with matched patients in the CHORD group. The late ejection fraction and mitral gradient were not different between the 2 groups in matched patients, respectively (P = .9 and P = .2, respectively). CONCLUSIONS: The use of the CHORD technique for degenerative mitral regurgitation increased the repair rates, but the CHORD technique had slightly lower repair durability at 10 years compared with the RESECT technique. These results could be related to more complex disease in CHORD group.

Late Follow-up for a Randomized Trial of Surgical Treatment of Tricuspid Valve Regurgitation in Patients Undergoing Left Ventricular Assist Device Implantation.

OBJECTIVES: We previously reported that concurrent tricuspid valve surgery (TVS) was not associated with a lower incidence of early RHF among patients undergoing durable LVAD implantation. This is a follow-up analysis to further define the clinical impact of concurrent TVS within 12-months of follow-up. METHODS: Patients with moderate or severe TR on pre-operative echocardiography (n=71) were randomized to either LVAD implantation alone (No TVS, n=34) or with concurrent TVS (TVS, n=37). Randomization was stratified by pre-operative right ventricular dysfunction. Patients were followed for at least 12-months after surgery. The incidence of RHF was determined using INTERMACS criteria by an adjudication committee. Functional studies and repeat echocardiography were performed at 12-months. RESULTS: Demographics were similar between the two arms. At 12-months, the rate of moderate or severe RHF was 50.0% (No TVS) versus 51.4% (TVS). No patients developed RHF between 6- and 12-months following the procedure. Death from RHF was 5.4% (TVS) versus 8.8% (No TVS). At 12-months, there was no significant difference in TR severity between the two arms due to improvement in TR severity in the No TVS arm. On cardiopulmonary exercise testing at 12+ months, there was no significant difference in peak oxygen consumption. CONCLUSIONS: In patients with significant pre-implant TR, the severity of TR improved over time in the LVAD implantation alone arm. By 12-months, there is no significant difference in TR severity between the two arms. This may account for the lack of difference in late clinical or functional parameters.