Coronavirus Disease 2019 in Solid Organ Transplant: A Multicenter Cohort Study.

BACKGROUND: The coronavirus disease 2019 (COVID-19) pandemic has led to significant reductions in transplantation, motivated in part by concerns of disproportionately more severe disease among solid organ transplant (SOT) recipients. However, clinical features, outcomes, and predictors of mortality in SOT recipients are not well described. METHODS: We performed a multicenter cohort study of SOT recipients with laboratory-confirmed COVID-19. Data were collected using standardized intake and 28-day follow-up electronic case report forms. Multivariable logistic regression was used to identify risk factors for the primary endpoint, 28-day mortality, among hospitalized patients. RESULTS: Four hundred eighty-two SOT recipients from >50 transplant centers were included: 318 (66%) kidney or kidney/pancreas, 73 (15.1%) liver, 57 (11.8%) heart, and 30 (6.2%) lung. Median age was 58 (interquartile range [IQR] 46-57), median time post-transplant was 5 years (IQR 2-10), 61% were male, and 92% had ≥1 underlying comorbidity. Among those hospitalized (376 [78%]), 117 (31%) required mechanical ventilation, and 77 (20.5%) died by 28 days after diagnosis. Specific underlying comorbidities (age >65 [adjusted odds ratio [aOR] 3.0, 95% confidence interval [CI] 1.7-5.5, P < .001], congestive heart failure [aOR 3.2, 95% CI 1.4-7.0, P = .004], chronic lung disease [aOR 2.5, 95% CI 1.2-5.2, P = .018], obesity [aOR 1.9, 95% CI 1.0-3.4, P = .039]) and presenting findings (lymphopenia [aOR 1.9, 95% CI 1.1-3.5, P = .033], abnormal chest imaging [aOR 2.9, 95% CI 1.1-7.5, P = .027]) were independently associated with mortality. Multiple measures of immunosuppression intensity were not associated with mortality. CONCLUSIONS: Mortality among SOT recipients hospitalized for COVID-19 was 20.5%. Age and underlying comorbidities rather than immunosuppression intensity-related measures were major drivers of mortality.

Unplanned readmission after outpatient laparoscopic cholecystectomy.

BACKGROUND: Readmission after surgery has been considered as a measure of quality of hospital and surgical care. This study aims to investigate unplanned readmission after laparoscopic cholecystectomy. METHODS: The NSQIP database was used to investigate 30 days unplanned readmission after laparoscopic cholecystectomy. Multivariate analysis was used to identify predictors of readmission. RESULTS: We found a total of 117,248 patients who underwent outpatient laparoscopic cholecystectomy during 2014-2016. Of these 3315 (2.8%) had unplanned readmission. Overall, 90% of readmitted patients were discharged after one day of hospitalization. Pain (14.07%) followed by unspecified symptoms including fever, nausea, vomiting, ileus was the most common reason for readmission. After adjustment, factors such as renal failure on dialysis (AOR: 2.26, P < 0.01), discharge to a facility (AOR: 1.93, P < 0.01), and steroid use for chronic condition (AOR: 1.51, P < 0.01), were associated with unplanned readmission. CONCLUSION: Overall, 2.8% of the patients undergoing outpatient laparoscopic cholecystectomy are readmitted to the hospital. Most of such patients are discharged after one day of hospitalization. Unspecified symptoms such as pain and vomiting were the most common reasons for readmission. Readmission strongly influences patients' comorbid factors and it is not a reliable measurement of quality of hospital and surgical care.

Timely Post-discharge Telephone Follow-Up is a Useful Tool in Identifying Post-discharge Complications Patients After Congenital Heart Surgery.

The objective of this study was to evaluate the effect of structured post-discharge telephone follow-up (TFU) on the time to the first postoperative clinic visit and early unplanned hospital readmissions in patients after congenital heart surgery. Structured phone calls delivered by senior surgical practitioners were made 1-4 days post-discharge. Demographics and clinical outcomes of pediatric patients receiving a TFU from 2012 to 2014 were assessed. In total, 196 phone calls were made in 165 patients. Thirty-four health problems were identified in 32 (19 %) patients (15 infants, 9 children, 8 neonates). Sixty-nine percent (n = 22) of the patients with problems identified at TFU were males. Fifty-three percent (n = 17) of the patients with problems identified at TFU were RACHS 2. Most of the problems (53 %) were identified in middle-class economic families. Gastrointestinal and incision site complications were the most common problems identified. Eighteen (56 %) patients had adjustments of medications. Six (19 %) TFUs resulted in earlier than scheduled post-op clinic visits. Overall incidence of unplanned readmissions was 16 % and similar between the patients that had problems during TFU (13 %) and patients that did not have problems identified at TFU (18 %; p = 0.50). Our study demonstrates the potential impact of the timely and structured post-discharge TFU in identifying post-discharge complications and modifying discharge instructions. When TFU identifies a problem, the interventions may be successful in preventing readmissions before first postoperative clinic visit. TFUs may be helpful, as a supplement standard of care with specific focus on patients <1 year of age to help identify adverse events that could otherwise escalate.

Statistical Power of Randomized Controlled Trials in Trauma Surgery.

BACKGROUND: Our purpose was to conduct a bibliometric study investigating the prevalence of underpowered randomized controlled trials (RCTs) in trauma surgery. STUDY DESIGN: A medical librarian conducted a search of RCTs in trauma published from 2000 to 2021. Data extracted included study type, sample size calculation, and power analyses. Post hoc calculations were performed using a power of 80% and an alpha level of 0.05. A CONSORT checklist was then tabulated from each study as well as a fragility index for studies with statistical significance. RESULTS: In total 187 RCTs from multiple continents and 60 journals were examined. A total of 133 (71%) were found to have "positive" findings consistent with their hypothesis. When evaluating their methods, 51.3% of articles did not report how they calculated their intended sample size. Of those that did, 25 (27%) did not meet their target enrollment. When examining post hoc power, 46%, 57%, and 65% were adequately powered to detect small, medium, and large effect sizes, respectively. Only 11% of RCTs had complete adherence with CONSORT reporting guidelines and the average CONSORT score was 19 out of 25. For positive superiority trials with binary outcomes, the fragility index median (interquartile range) was 2 (2 to 8). CONCLUSIONS: A concerningly large proportion of recently published RCTs in trauma surgery do not report a priori sample size calculations, do not meet enrollment targets, and are not adequately powered to detect even large effect sizes. There exists opportunity for improvement of trauma surgery study design, conduct, and reporting.

Pulmonary barotrauma in mechanically ventilated coronavirus disease 2019 patients: A case series.

BACKGROUND: Coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) may result in hypoxic respiratory failure necessitating mechanical ventilation. Barotrauma is a well-documented complication of mechanical ventilation. OBJECTIVE: To describe the presentation, characteristics, and management of mechanically ventilated patients with COVID-19 who developed barotrauma. METHODS: Retrospective case series study of 13 adult, mechanically ventilated, laboratory-confirmed COVID-19 positive patients admitted between 3/15/2020 and 4/14/2020 to a community hospital in New York City. Patient demographics, clinical course, ventilatory parameters, and radiographic results were obtained from electronic medical records. Barotrauma was defined as pneumomediastinum, subcutaneous emphysema, and or pneumothorax on chest X-ray. Descriptive analyses and Mann-Whitney U test were performed, where appropriate. RESULTS: Of the 574 COVID-19 positive patients, 139 (24.2%) needed mechanical ventilation and 13 (9.4%) of those developed barotrauma. Majority of patients were Black race (92.3%), older than age 65 (56.8%), male (69.2%), and had comorbidities (76.9%). Most common presenting symptoms were cough (84.6%) and dyspnea (76.9%). Barotrauma presentations included 3/13 pneumothoraces and pneumomediastinum, 12/13 pneumomediastinum and subcutaneous emphysema, and 1/13 pneumothorax alone. The average days on ventilator was 3.4, average positive expiratory-end pressure 15.5 cmH2O, dynamic compliance 33.8 mL/cmH2O, and P/F ratio 165. Interventions were 4/13 chest tubes and 2/13 pigtail catheters. CONCLUSIONS: Barotrauma is a common complication of mechanical ventilation of COVID-19 patients. Despite high ventilatory pressures, tension pneumothorax is rare and barotrauma could potentially be managed conservatively. Further studies are needed to evaluate the indication and outcome of thoracostomies and conservative management.

Improving SCD compliance in trauma patients at Kings County Hospital Center: a quality improvement report.

Venous thromboembolism (VTE) is the fourth most commonly reported complication in trauma patients. For these patients, thromboprophylaxis is a standard of care. Patient compliance with sequential compression devices (SCDs), a form of mechanical VTE prophylaxis, has been a focus of efforts to improve patient safety. At our institution, a baseline audit in July 2020 revealed that patients admitted to the trauma floors have poor compliance with the use of SCDs. In this quality improvement project, we developed a patient education intervention to improve SCD compliance. We distributed an informational flyer to patients and led short educational sessions on VTE risk factors and proper SCD use. Our aim was to increase our SCD compliance rate by 30% in 4 weeks. We used three plan-do-study-act (PDSA) cycles to implement and refine our intervention. We measured SCD compliance during morning and afternoon patient observations and generated run charts to understand how our cycles were leading to change. After a 4-week period, we did not achieve our aim, but increased our overall compliance from 45% to 60% and sustained this improvement throughout our PDSA cycles. Morning compliance was lower than afternoon compliance both at baseline (45% vs 48.5%) and at the end the project (45% vs 53%). Our results suggest that patient education should be coupled with interventions that address other barriers to SCD compliance.

Saving the split: the benefits of VATS thymectomy.

BACKGROUND: With the advent of minimally invasive techniques, the standard approaches to many surgeries have changed. We compared the financial costs and health care outcomes between standard thymectomy via sternotomy and video assisted thoracoscopic surgery (VATS). METHODS: A 3-year review [2010-2012] of the National Inpatient Sample (NIS) was performed. All patients undergoing thymectomy were included. Patients undergoing VATS thymectomy were identified. Outcomes measured were hospital length of stay (LOS), hospital charges, and mortality. Univariate and multivariate analyses were performed to control for demographics and comorbidities. RESULTS: The results of 2,065 patients who underwent thymectomy were analyzed, of which 373 (18.1%) had VATS thymectomy and 1,692 (81.9%) had standard thymectomy. Mean age was 52.8±16, 42.5% were male, and 65.5% were Caucasian. There was a significant interval increase in number of patients undergoing VATS thymectomy (10% in 2010 vs. 19.2% in 2012, P<0.001). Patients undergoing standard thymectomy had longer hospital LOS (6.8±6.6 vs. 3.3d±3.4 d, P<0.001), hospital charges $88,838±$120,892 vs. $57,251±$54,929) and hospital mortality (0.9% vs. 0%, P=0.01). In multivariate analysis, thymectomy via sternotomy was independently associated with increased hospital LOS B =1.6 d, P<0.001) and charges (B = $13,041, P=0.041). CONCLUSIONS: Our study demonstrates decreased hospital length of stay and reduced hospital charges in patients undergoing VATS thymectomy compared to standard thymectomy. Our data demonstrates that the prevalence of VATS thymectomies is increasing, likely related to improved healthcare and financial outcomes.

Efficacy of Aortic Valve Resuspension in Establishing Valve Competence in Acute Type A Dissections.

BACKGROUND: This study investigates the efficacy of aortic valve (AV) resuspension with preservation of the native aortic root in maintaining AV competence during type A dissection repair. METHODS: A total of 154 acute type A dissection repairs were performed from January 2000 to July 2015. AV resuspension was performed in 120 patients to address AV insufficiency (AI). Survival data were derived from 120 patients who had AV resuspensions and all 154 acute type A dissection repairs. RESULTS: Of the 70 patients who presented initially with moderate-to-severe AI, 43 underwent AV resuspension. Echocardiographic data for analysis were available in 40 of these 43 patients. In the group with moderate-to-severe AI at presentation, AV resuspension was able to achieve mild or less AI in 38 of 40 patients (95%) and trivial or no AI in 29 of 40 patients (73%) after weaning from cardiopulmonary bypass. The presence of moderate-to-severe preoperative AI did not predict the ability to achieve trivial or no AI with resuspension immediately after coming off cardiopulmonary bypass (p = 0.3) or on subsequent follow-up (p = 0.8). Mean echocardiographic follow-up for AV resuspension was 1.21 ± 2.57 years. Three patients who underwent AV resuspension required AV reoperation at follow-up. There was no survival difference between patients who did or did not have AV resuspension (p = 0.3). CONCLUSIONS: AV resuspension is able to improve valve competency with good outcomes even in patients with moderate or severe AI at presentation. Overall long-term survival is unchanged compared with other operative strategies for the AV.

To use or not to use? Amiodarone before heart transplantation.

BACKGROUND: Amiodarone frequently is used in patients with heart failure. Concerns still exist about possible complications related to its lingering effect during and after heart transplantation. METHODS: We selected all consecutive patients who received a heart transplant at our institution between January 2004 and December 2015 (n = 220) and compared the peri- and postoperative outcomes of patients who were taking amiodarone for at least 120 days before heart transplant (n = 127) with patients who did not take amiodarone prior to heart transplant (n = 93). RESULTS: Compared with patients with no amiodarone use prior to transplant, those who had used amiodarone were similar in age, body mass index, sex, cause of cardiomyopathy, prevalence of diabetes, hypertension, presence of defibrillator, and had similar donor ischemic times during transplant (all P > .05). Median operative time, aortic cross clamp time, mechanical ventilation and median hospital duration of stay did not differ between the 2 groups (P > .05). Patients exposed to amiodarone had fewer cellular rejections (5% vs 20%; P = .001) but more primary graft dysfunction (4% vs 0%; P = .025) and post-transplant pneumonia (P = .047) compared with patients not taking amiodarone prior to transplant. Both groups had similar rate of atrial fibrillation, 30-day readmission, and 30-day mortality (P > .05). Even though 1-year survival was not affected by amiodarone use (P = .51), long-term (5-year) survival was significantly less in patients exposed to amiodarone (P = .03). CONCLUSION: Amiodarone use did not affect the incidence of atrial fibrillation nor 30-day and 1-year survival post-transplantation. Nevertheless, post-transplant pulmonary complications were significantly greater and 5-year survival was less among patients treated with amiodarone prior to transplant.

Short-term clinical outcomes after off-pump coronary artery bypass grafting at a single Veterans Affairs Medical Center.

BACKGROUND: We retrospectively assessed the outcomes after coronary revascularization at a single Veterans Affairs Medical Center when a strategy of assigning higher risk patients to off-pump coronary artery bypass grafting (CABG) was employed. METHODS: Over a 5 year period all consecutive patients that underwent CABG at our VA Medical Center were assigned to a surgeon who either performs the CABG exclusively off-pump or to one who performed the CABG on-pump. The higher risk patients were assigned preferentially for off-pump revascularization. VASQIP (VA Hospitals Surgical Quality Improvement Program) data between 10/2007 and 12/2012 were retrospectively reviewed at our VA Medical Center and the short term outcomes were assessed. RESULTS: A total of 252 consecutive patients underwent off-pump CABG (n = 170) and on-pump CABG (n = 82). There were significantly more patients with low LVEF (<45 %; p = 0.008) and cerebrovascular disease in the off-pump group (p = 0.024). The number of patients smoking at the time of surgery was significantly higher in the off-pump group (p = 0.002) as well. The 30-day composite morbidity and mortality was 6 % for all CABG patients and significantly lower with off-pump vs. on-pump CABG (3.5 % vs. 11 %; p = 0.019). There were no conversions from off-pump to on-pump surgery. CONCLUSIONS: A selective strategy to direct higher risk patients towards an off-pump revascularization yielded favorable outcomes in an unselected veteran population treated at a single VA Medical Center over a 5 year period.

Recurrent severe aortic stenosis one year after transcatheter aortic valve-in-valve implantation: Successful treatment with balloon aortic valvuloplasty.

Transcatheter aortic valve-in-valve (VIV) implantation has evolved as one of the primary therapeutic modalities in patients with failed surgical bioprosthesis allowing a reduction in rate of surgical reintervention. We report a case of a 90-year-old woman who had previously undergone aortic valve replacement with 21-mm Carpentier-Edwards valve in 1999 followed by 23 mm Sapien VIV in March 2013. She developed severe recurrent aortic stenosis 1-year post-VIV which was successfully treated with balloon aortic valvuloplasty (BAV). BAV can be a favorable treatment option allowing considerable symptomatic relief and improvement in performance of daily activities in extreme age patients who develop restenosis after VIV implantation and are high-risk candidates for both redo-surgical aortic valve replacement and redo-VIV implantation. .

Hospital Readmissions After Continuous-Flow Left Ventricular Assist Device Implantation: Incidence, Causes, and Cost Analysis.

BACKGROUND: We investigated the incidence and causes of unplanned hospital readmissions after continuous-flow (CF) left ventricular assist device (LVAD) implantation. We also analyzed the impact of unplanned readmissions on post-CF-LVAD survival and the costs associated with each cause of readmission. METHODS: We retrospectively reviewed 126 patients who underwent implantation with a CF-LVAD from January 2007 to December 2013. The timing of readmissions, hospital length of stay, and total length of device support were evaluated. Patients were followed up while receiving support, until transplantation, or until death. Direct hospital costs associated with each readmission were analyzed. RESULTS: In all, 103 patients underwent implantation for bridge to transplantation and 19 patients for destination therapy; 68 patients were readmitted 156 times (2.2 times/patient) as of the end of follow-up. The median follow-up period was 11 months. While receiving device support, patients spent 93% of their time out of the hospital. The causes of readmission included gastrointestinal bleeding (19%), driveline infection (13%), and stroke (8%). The median time to first readmission was 35 days. Thirty (44%) patients were readmitted within 30 days after discharge. The median direct hospital cost of a single readmission was $7,546. Device malfunction and arrhythmias were the most costly causes of readmission. There was no significant difference in long-term survival between readmitted patients and those who were not readmitted. CONCLUSIONS: Gastrointestinal bleeding and CF-LVAD-related infections were the leading causes of readmission. Patients with a CF-LVAD spent 93% of their time out of hospital after implantation, and readmissions did not have a negative impact on long-term survival. New approaches to minimize these adverse events will continue to improve the efficacy and decrease the cost of CF-LVAD therapy.

A novel approach to prevent post-operative ileus after continuous-flow left ventricular assist device implantation: A retrospective cohort study.

INTRODUCTION: Patients with postoperative ileus (POI), a common post-surgical event, experience intense discomfort. Various treatments targeting prevention of POI have shown to have an unpredictable effect. We introduced a novel postoperative bowel management protocol in patients implanted with a continuous-flow left ventricular assist device (CF-LVAD). The effect of this protocol on POI was evaluated. METHODS: Patients receiving an old bowel management protocol (OBMP; 01/2007-03/2009) were compared with those receiving a new bowel management protocol (NBMP; 04/2009-12/2013). The OBMP consisted of advancing the diet as tolerated, bisacodyl suppositories and enemas with the goal of a bowel movement (BM) every 3 days. The NBMP consisted of clear liquids until first BM is achieved, then full liquids until the second BM, then advancing to goal diet. Docusate is given on postoperative day (POD) 1 and bisacodyl PR on POD2 with enemas if ileus develops. Enemas are added POD3 if no BM has occurred. Polyethylene glycol is considered daily for patients prone to constipation. The goal is a BM every 2 days. Patients were made nil per os (NPO) with any signs of ileus. RESULTS: One hundred eighteen patients were implanted with CF-LVADs during the study period. The incidence of ileus significantly decreased from 19% in the OBMP group to 4% percent in the NBMP group (p < 0.05). In-hospital mortality was not different between the two groups (6% vs. 2% p = 0.35). CONCLUSIONS: A novel postoperative bowel management protocol successfully decreased the incidence of POI following CF-LVAD implant surgery at our institution.

Impact of age on outcomes following continuous-flow left ventricular assist device implantation.

OBJECTIVES: The goal of our study was to analyse the impact of age on outcomes in patients who underwent continuous-flow left ventricular assist device (CF-LVAD) placement at our institution. METHODS: One hundred and twenty-eight patients were implanted with a CF-LVAD between January 2008 and June 2014. Eighty-five patients were implanted with the device as a bridge to transplant (BTT); the remaining (n = 43) were on destination therapy (DT). Each group was divided into patients <65 years old and ≥ 65 years old at device implantation. Patients were followed up for at least 24 months or until transplant or death. RESULTS: Eighty-five patients (66%) received a CF-LVAD as BTT. Patients ≥ 65 years old (n = 8) had a lower preoperative cardiac index and prothrombin time-international normalized ratio (P = 0.009), and a longer stay in the intensive care unit (P = 0.008). Adverse events including infections, re-exploration for bleeding, ischaemic and haemorrhagic stroke, renal failure and right heart failure were comparable in both age groups. Eighty-two percent (n = 63) of the young patients and 75% (n = 6) of the older patients, who were on LVAD as BTT, underwent heart transplant within the first 24 months of LVAD implantation. Overall survival at 3, 6, 12 and 24 months were 95, 95, 77 and 70%, respectively, post-CF-LVAD implantation as BTT for the younger group and 73% for the older group at 3, 6 and 12 months (P = 0.35). Forty-three patients (34%) received a CF-LVAD as DT. Patients ≥ 65 years old (n = 14) on DT had a higher incidence of peripheral vascular disease (P = 0.048), higher serum sodium (P = 0.004) and serum creatinine values (P = 0.002), preoperatively. There were more strokes in the older patients post-LAVD implantation (14 vs 0%; P = 0.048). Overall survival at 3, 6, 12 and 24 months were 85, 79, 75 and 62%, respectively, for the younger group and 93, 77, 67 and 34% for the older group, respectively (P = 0.26). CONCLUSIONS: This study demonstrates that LVAD therapy can be used in the older patients with acceptable mortality and morbidity, and age alone should not be used as the sole criterion for exclusion from LVAD implantation.