Multicenter evaluation of left ventricular assist device implantation with or without ECMO bridge in cardiogenic shock.

BACKGROUND: The efficacy of extracorporeal membrane oxygenation (ECMO) as a bridge to left ventricular assist device (LVAD) remains unclear, and recipients of the more contemporary HeartMate 3 (HM3) LVAD are not well represented in previous studies. We therefore undertook a multicenter, retrospective study of this population. METHODS AND RESULTS: INTERMACS 1 LVAD recipients from five U.S. centers were included. In-hospital and one-year outcomes were recorded. The primary outcome was the overall mortality hazard comparing ECMO versus non-ECMO patients by propensity-weighted survival analysis. Secondary outcomes included survival by LVAD type, as well as postoperative and one-year outcomes. One hundred and twenty-seven patients were included; 24 received ECMO as a bridge to LVAD. Mortality was higher in patients bridged with ECMO in the primary analysis (HR 3.22 [95%CI 1.06-9.77], p = 0.039). Right ventricular assist device was more common in the ECMO group (ECMO: 54.2% vs non-ECMO: 11.7%, p < 0.001). Ischemic stroke was higher at one year in the ECMO group (ECMO: 25.0% vs non-ECMO: 4.9%, p = 0.006). Among the study cohort, one-year mortality was lower in HM3 than in HeartMate II (HMII) or HeartWare HVAD (10.5% vs 46.9% vs 31.6%, respectively; p < 0.001) recipients. Pump thrombosis at one year was lower in HM3 than in HMII or HVAD (1.8% vs 16.1% vs 16.2%, respectively; p = 0.026) recipients. CONCLUSIONS: Higher mortality was observed with ECMO as a bridge to LVAD, likely due to higher acuity illness, yet acceptable one-year survival was seen compared with historical rates. The receipt of the HM3 was associated with improved survival compared with older generation devices.

Five-Year Cardiovascular Outcomes after Infective Endocarditis in Patients with versus without Drug Use History.

Background: Disparities in treatment and outcomes of infective endocarditis (IE) between people who use drugs (PWUD) and non-PWUD have been reported, but long-term data on cardiovascular and cerebrovascular outcomes are limited. We aim to compare 5-year rates of mortality, cardiovascular and cerebrovascular events after IE between PWUD and non-PWUD. Methods: Using data from the TriNetX Research Network, we examined 5-year cumulative incidence of mortality, myocardial infarction, heart failure, atrial fibrillation/flutter, ventricular tachyarrhythmias, ischemic stroke, and intracranial hemorrhage in 7132 PWUD and 7132 propensity score-matched non-PWUD patients after a first episode of IE. We used the Kaplan−Meier estimate for incidence and Cox proportional hazards models to estimate relative risk. Results: Matched PWUD were 41 ± 12 years old; 52.2% men; 70.4% White, 19.8% Black, and 8.0% Hispanic. PWUD had higher mortality vs. non-PWUD after 1 year (1−3 year: 9.2% vs. 7.5%, p = 0.032; and 3−5-year: 7.3% vs. 5.1%, p = 0.020), which was largely driven by higher mortality among female patients. PWUD also had higher rates of myocardial infarction (10.0% vs. 7.0%, p < 0.001), heart failure (19.3% vs. 15.2%, p = 0.002), ischemic stroke (8.3% vs. 6.3%, p = 0.001), and intracranial hemorrhage (4.1% vs. 2.8%, p = 0.009) compared to non-PWUD. Among surgically treated PWUD, interventions on the tricuspid valve were more common; however, rates of all outcomes were comparable to non-PWUD. Conclusions: PWUD had higher 5-year incidence of cardiovascular and cerebrovascular events after IE compared to non-PWUD patients. Prospective investigation into the causes of these disparities and potential harm reduction efforts are needed.

SAVE score with lactate modification predicts in-hospital mortality in patients with ongoing cardiac arrest during VA-ECMO cannulation.

The survival after veno-arterial extracorporeal membrane oxygenation score and its lactate modification predict in-hospital mortality in patients based on pre-extracorporeal membrane oxygenation variables. Cardiac arrest history is a significant variable in these scores; however, patients with ongoing cardiac arrest during cannulation were excluded from these models. The goal of this study is to validate the survival after veno-arterial extracorporeal membrane oxygenation score with a lactate modification among patients with ongoing cardiac arrest. In our study, the survival after veno-arterial extracorporeal membrane oxygenation score predicted mortality in all patients, but did so with higher discrimination among ongoing cardiac arrest patients with a lactate modification.

Survival and Outcomes After Cardiac Arrest With VA-ECMO Rescue Therapy.

BACKGROUND: Extracorporeal membrane oxygenation (ECMO) use in patients with cardiac arrest is increasing. Utilization remains variable between centers using ECMO as a rescue therapy or early protocolized extracorporeal cardiopulmonary resuscitation. METHODS: Single-center, retrospective evaluation of cardiac arrest with cardiopulmonary resuscitation and rescue ECMO support from 2011 through 2019. Study objectives included survival, non-neurologic, and neurologic outcomes; validation of the SAVE and modified SAVE (mSAVE) scores for survival and favorable neurologic outcome; and predictive factor identification in cardiac arrest with ECMO rescue therapy. RESULTS: Eighty-nine patients were included. In-hospital survival was 38.2% and median CPC score was 2. Survivors had lower BMI (27.9 ±â€Š4.2 kg/m2 vs. 32.3 ±â€Š7.5 kg/m2, P = 0.003), less obesity (BMI ≥ 30 kg/m2) (26.5% vs. 49.1%, P = 0.035), shorter CPR duration (35.5 ±â€Š31.7 m vs. 58.0 ±â€Š49.5 m, P = 0.019), more tracheostomy (38.2% vs. 7.3%, P < 0.001), and less renal replacement therapy (RRT) (17.6% vs. 38.2%, P = 0.031). Patients with a favorable neurologic outcome had lower body weight (86.2 ±â€Š17.9 kg vs. 98.1 ±â€Š19.4 kg, P = 0.010), lower BMI (28.1 ±â€Š4.5 kg/m2 vs. 33.9 ±â€Š7.9 kg/m2, P < 0.001), and less obesity (29.7% vs. 56.3%, P = 0.026). mSAVE score predicted in-hospital survival (OR 1.11; 95%CI 1.03-1.19; P = 0.004) and favorable neurologic outcome (OR 1.11; 1.03-1.20; P = 0.009). Multivariate analysis for in-hospital survival included mSAVE, BMI, CPR-time, tracheostomy, and RRT (c-statistic: 0.864). Favorable neurologic outcome included mSAVE and BMI (c-statistic: 0.805). CONCLUSIONS: mSAVE, BMI, RRT, and tracheostomy are predictors of in-hospital survival and mSAVE and BMI are predictors of favorable neurologic outcome in cardiac arrest with ECMO rescue therapy.

Long-term discontinuation of antithrombotic therapy in patients with HeartMate II continuous-flow left ventricular assist device support.

Recurrent bleeding events are a common complication of left ventricular assist devices leading to significant morbidity. Clinicians may be reluctant to discontinue all antithrombotic therapies in this setting because of the risk of thrombotic events. To evaluate the safety of this strategy, we conducted a retrospective review of patients within our institution's left ventricular assist device program from February 2010 to July 2018 who had all antithrombotic therapies discontinued in response to recurrent bleeding events requiring hospitalization. Thrombotic and bleeding outcomes after discontinuation of therapy were assessed and compared. Seven patients out of 87 (8%) were identified and included in this analysis. One patient experienced pump thrombosis in the setting of driveline infection with an overall rate of thrombotic events of 0.08 per-patient-year. Sixteen gastrointestinal bleeding events occurred after discontinuation of antithrombotic therapy (1.35 per-patient-year) compared with 37 prior to discontinuation (4.28 per-patient-year) resulting in a significant reduction (reduction rate = 0.32; 95% confidence interval = [0.17, 0.58]; p < .001). Thrombotic complications were rare among patients with HeartMate II left ventricular assist device support who suffered recurrent bleeding events and in whom antithrombotic therapy was, therefore, discontinued. Gastrointestinal bleeding was significantly reduced in this group; however, angioectasia-related gastrointestinal bleedings remained problematic.

Ventricular Assist Device Implantation Configurations Impact Overall Mechanical Circulatory Support System Thrombogenic Potential.

Ventricular assist devices (VADs) became in recent years the standard of care therapy for advanced heart failure with hemodynamic compromise. With the steadily growing population of device recipients, various postimplant complications have been reported, mostly associated with the hypershear generated by VADs that enhance their thrombogenicity by activating platelets. Although VAD design optimization can significantly improve its thromboresistance, the implanted VAD need to be evaluated as part of a system. Several clinical studies indicated that variability in implantation configurations may contribute to the overall system thrombogenicity. Numerical simulations were conducted in the HeartAssist 5 (HA5) and HeartMate II (HMII) VADs in the following implantation configurations: 1) inflow cannula angles: 115° and 140° (HA5); 2) three VAD circumferential orientations: 0°, 30°, and 60° (HA5 and HMII); and 3) 60° and 90° outflow graft anastomotic angles with respect to the ascending aorta (HA5). The stress accumulation of the platelets was calculated along flow trajectories and collapsed into a probability density function, representing the "thrombogenic footprint" of each configuration-a proxy to its thrombogenic potential (TP). The 140° HA5 cannula generated lower TP independent of the circumferential orientation of the VAD. Sixty-degree orientation generated the lowest TP for the HA5 versus 0° for the HMII. An anastomotic angle of 60° resulted in lower TP for HA5. These results demonstrate that optimizing the implantation configuration reduces the overall system TP. Thromboresistance can be enhanced by combining VAD design optimization with the surgical implantation configurations for achieving better clinical outcomes of implanted VADs.

Surveillance of moderate-size aneurysms of the thoracic aorta.

BACKGROUND: There are no evidence based guidelines for the surveillance of patients with moderate-sized (<5 cm) thoracic aortic aneurysms (MTAA), who do not warrant surgical intervention. The purpose of this study was to review the MTAA patient surveillance strategy used currently at the Northport Veterans Affairs Medical Center, to assess outcomes over time and accrue data to develop guidelines to optimize MTAA patients' follow-up. METHODS: The study group included veterans referred to the Thoracic Surgery clinic for the management of moderate-sized (<5 cm) thoracic aortic aneurysms (MTAA) not warranting immediate surgical repair. As a pilot study, all MTAA patients' charts from 2005-2013 were reviewed to describe imaging practices and evaluate patient-specific long-term outcomes. An adverse composite endpoint was defined if a patient's aneurysm grew substantially (≥0.5 cm/year or reached 5.5 cm) or a MTAA-related event (surgery or death) occurred. Additionally, number of CT scans obtained during the follow up period were documented. RESULTS: For 110 MTAA patients, the average presenting index size was 4.45 ± 0.4 cm with average growth of 0.04 cm total (0.03 cm/year). Fourteen (13%) patients met the adverse composite endpoint, with no MTAA-related deaths. Patients achieving the adverse composite endpoint had higher index sizes (4.81 vs. 4.40 cm, p = 0.001) and higher average growth rates as compared to non-endpoint patients (0.16 vs. 0.01 cm, p = 0.0009). Optimizing the negative likelihood ratio defined a new "not-at-risk" population with aneurysm index size < 4.3 cm. A shorter time to adverse event for "at-risk" patients was found versus "not-at-risk" patients (p = 0.02). On average, there were 4.8 CT scans/patient and estimated cumulative radiation dose of 34 mSv/patient. Only one "not-at-risk" patient had substantive MTAA growth (≥0.5 cm/year) over the 8 year follow-up period. CONCLUSION AND RELEVANCE: Annual imaging of MTAA "not-at-risk" patients appears unwarranted, resulting in potentially excessive radiation exposure. Although additional research is necessary for validation, longer surveillance imaging intervals (beyond one year) seem appropriate for MTAA patients presenting with < 4.3 cm index aneurysms.

Simulated laparoscopic sigmoidectomy training: responsiveness of surgery residents.

PURPOSE: This study aimed to evaluate the responsiveness of surgery residents to simulated laparoscopic sigmoidectomy training. METHODS: Residents underwent simulated laparoscopic sigmoidectomy training for previously tattooed sigmoid cancer with use of disposable abdominal trays in a hybrid simulator to perform a seven-step standardized technique. After baseline testing and training, residents were tested with predetermined proficiency criteria. Content validity was defined as the extent to which outcome measures departed from clinical reality. Content-valid measures of trays were evaluated by two blinded raters. Simulator-generated metrics included path length and smoothness of instrument movements. Responsiveness was defined as change in performance over time and was assessed by comparing baseline testing with unmentored final testing. RESULTS: For eight weeks, eight postgraduate year 3/4 residents performed 34 resections. Overall operating time (67 vs. 37 min; P = 0.005), flexure (10 vs. 5 min; P = 0.005), inferior mesenteric vessel (8 vs. 5 min; P = 0.04), and ureter (7 vs. 1 min; P = 0.003) times improved significantly. Content-valid measures from trays remained unchanged. Path length (27,155.2 mm) and smoothness (3,575.5 cm/s3) of instrument movement remained unchanged. There were two bowel perforations and 19 anastomotic leaks. Leak rate decreased from 87% to 12.5%. Strong correlation was found between path length and smoothness of instrument movements (r = 0.9; P < 0.001). There was no correlation between simulator-generated metrics and content-valid outcome measures. Interrater reliability was 1.0 for all measures except anastomotic leak (k = 0.56). There was a linear relationship between residents' clinical advanced laparoscopic case volume and responsiveness (r = -0.7; P = 0.04). CONCLUSIONS: Simulated laparoscopic sigmoidectomy training affected responsiveness in surgery residents with significantly decreased operating time and anastomotic leak rate.

Does reported funding differ by gender in the surgical literature?

BACKGROUND: It is commonly believed that women surgeons are less likely to be funded and to publish than their male counterparts. According to the American Board of Surgery, currently 13.5% of board-certified surgeons are women. OBJECTIVE: We compared first authorship and reported funding of original articles in the surgical literature by gender. METHODS: We conducted a structured review of all original articles during 2006 from 4 major surgical journals (Annals of Surgery, Archives of Surgery, Surgery, and Journal of the American College of Surgeons). For each article, the gender and academic degree of the first author was determined as well as the study design, type and country of the institution, and source of funding, if any. chi tests were used to compare the rates of reported funding, academic degrees, and type of research by gender of author. A multivariate logistic regression model was used to determine the association between gender, degree, country, institution, and study design with funding. RESULTS: Of the 664 original research reports evaluated, 118 (17.8% [95% confidence interval (CI), 15.0-20.9]) were first-authored by women and 522 (78.6% [95% CI, 75.3-81.6]) by men (in 24 [3.6%], the gender of the first author was unknown). Two hundred fifty-eight (38.9% [95% CI, 35.2-42.6]) of the articles reported funding. Funding rates among men and women were not quite significantly different (37.0% vs. 45.8%, difference 8.8%; 95% CI, -1%-19%; P = 0.08). The percentage of randomized clinical trials (RCTs) among men and women first authors was similar (13.4% vs. 13.6%, P = 0.92). Female first authors were less likely to have a medical degree than male first authors (93 of 118 [78.8%] vs. 486 of 519 [93.6%], P < 0.0010). On multivariate analysis, non-RCTs were less likely to be funded than RCTs (odds ratio, 0.25; 95% CI, 0.14-0.40). CONCLUSIONS: The percentage of original surgical articles first authored by women is greater than the percentage of female surgeons. Funding rates of original articles were similar among men and women.

Modeling stroke risk after coronary artery bypass and combined coronary artery bypass and carotid endarterectomy.

BACKGROUND AND PURPOSE: The goals of this study were to compare the ability of statewide and institutional models of stroke risk after coronary artery bypass (CAB) to predict institution-specific results and to examine the potential additive stroke risk of combined CAB and carotid endarterectomy (CEA) with these predictive models. METHODS: An institution-specific model of stroke risk after CAB was developed from 1975 consecutive patients who underwent nonemergent CAB from 1994 to 1999 in whom severe carotid stenosis was excluded by preoperative duplex screening. Variables recorded in the New York State Cardiac Surgery Program database were analyzed. This model (model I) was compared with a published model (model II) derived from analysis of the same variables using New York statewide data from 1995. Predicted and observed stroke risks were compared. These formulas were applied to 154 consecutive combined CAB/CEA patients operated on between 1994 and 1999 to determine the predicted stroke risk from CAB alone and thereby deduce the maximal added risk imputed to CEA. RESULTS: Risk factors common to both models included age, peripheral vascular disease, cardiopulmonary bypass time, and calcified aorta. Additional risk factors in model I also included left ventricular hypertrophy and hypertension. Risk factors exclusive to model II included diabetes, renal failure, smoking, and prior cerebrovascular disease. Our observed stroke rate for isolated CAB was 1.7% compared with a rate predicted with model II (statewide data) of 1.56%. The observed stroke rate for combined CEA/CAB was 3.9%. When the Stony Brook model (model I) based on patients without carotid stenosis was used, the predicted stroke rate was 2.8%. When the statewide model (model II), which included some patients with extracranial vascular disease, was used, the predicted stroke rate was 3.4%. The differences between observed and predicted stroke rates were not statistically significant. CONCLUSIONS: Estimation of stroke risk after CAB was similar whether statewide data or institution-specific data were used. The statewide model was applicable to institution-specific data collected over several years. Common risk factors included age, aortic calcification, and peripheral vascular disease. The observed differences in the predicted stroke rates between models I and II may be due to the fact that carotid stenosis was specifically excluded by duplex ultrasound from the patient population used to develop model I. Modeling stroke risk after CAB is possible. When these models were applied to patients undergoing combined CAB/CEA, no additional stroke risk could be ascribed to the addition of CEA. Such models may be used to identify groups at increased risk for stroke after both CAB and combined CAB/CEA. The ultimate place for CEA in patients undergoing CAB will be defined by prospective randomized trials.