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Background The Society of Thoracic Surgeons (STS) Quality Measurement Task Force has developed risk models and composite performance measures for isolated coronary artery bypass grafting (CABG), isolated aortic valve replacement (AVR), isolated mitral valve replacement or repair (MVRR), AVR+CABG, and MVRR+CABG. To further enhance its portfolio of risk-adjusted performance metrics, STS has developed new risk models for multiple valve operations ± CABG procedures. Methods Using July 2011 to June 2019 STS Adult Cardiac Surgery Database data, risk models for AVR+MVRR (n = 31,968) and AVR+MVRR+CABG (n = 12,650) were developed with the following endpoints: Operative Mortality, major morbidity (any 1 or more of the following: cardiac reoperation, deep sternal wound infection/mediastinitis, stroke, prolonged ventilation, and renal failure), and combined mortality and/or major morbidity. Data were divided into development (July 2011 to June 2017; n = 35,109) and validation (July 2017 to June 2019; n = 9509) samples. Predictors were selected by assessing model performance and clinical face validity of full and progressively more parsimonious models. Performance of the resulting models was evaluated by assessing discrimination and calibration. Results C-statistics for the overall population of multiple valve ± CABG procedures were 0.7086, 0.6734, and 0.6840 for mortality, morbidity, and combined mortality and/or morbidity in the development sample, and 0.6953, 0.6561, and 0.6634 for the same outcomes, respectively, in the validation sample. Conclusions New STS Adult Cardiac Surgery Database risk models have been developed for multiple valve ± CABG operations, and these models will be used in subsequent STS performance metrics.

Objective Most of all congenital cardiac surgical programs participate in public outcomes reporting. The primary end point is transparency. In this era, academic programs with surgical residents face the challenge of producing outstanding results while allowing residents to learn by doing. We sought to understand the effect of education on our surgical outcomes. Methods We collected data for all American Board of Thoracic Surgery index cases done at our institution over a 10-year period. We identified 3406 cases and categorized them into 2 groups according to primary surgeon: attending (2269) versus resident (1137). In a multivariable logistic regression model we examined the effect of operating surgeon on in-hospital mortality, major morbidity, and length of stay. We used propensity score matching subsequently to balance differences between cohorts, and multivariable logistic regression was repeated. Results Using the entire cohort, multivariable logistic regression model adjusted for age, sex, weight, lack of preoperative comorbidity, presence of preoperative respiratory failure, The Society of Thoracic Surgeons--European Association for Cardio-Thoracic Surgery category, and need for deep hypothermic circulatory arrest, showed a higher odds of survival in the resident cohort (odds ratio, 1.484; 95% confidence interval, 0.998-2.206; P = .05). Propensity score matching identified 1137 pairs of attending and resident cases with well-balanced preoperative variables. Logistic regression modeling using the matched cohort showed equivalent 30-day mortality, 30-day major morbidity, and length of stay. Conclusions There was no difference in mortality, major morbidity, or length of stay when similar cases were compared that were operated on by attendings versus those by a resident. Effectively educating congenital heart surgeons without compromising an operation's quality requires thoughtful approach, including case selection and graded responsibility.

BACKGROUND Intra-aortic balloon pumps (IABP) are used to bridge select end-stage heart disease patients to heart transplant (HT). IABP use and exception requests both increased dramatically after the UNOS policy change (PC). The purpose of this study was to evaluate the effect of PC and exception status requests on waitlist and post-transplant outcomes in patients bridged to HT with IABP support. METHODS We analyzed adult, first-time, single-organ HT recipients from the UNOS Registry either on IABP at the time of registration for HT or at the time of HT. We compared waitlist and post-HT outcomes between patients from the PRE (October 18, 2016 to May 30, 2018) and POST (October 18, 2018 to May 30, 2020) eras using Kaplan-Meier curves and time-to-event analyses. RESULTS A total of 1267 patients underwent HT from IABP (261 pre-policy/1006 post-policy). On multivariate analysis, PC was associated with an increase in HT (sub-distribution hazard ratio (sdHR): 2.15, p

Tricuspid regurgitation is common in patients with severe degenerative mitral regurgitation. However, the evidence base is insufficient to inform a decision about whether to perform tricuspid-valve repair during mitral-valve surgery in patients who have moderate tricuspid regurgitation or less-than-moderate regurgitation with annular dilatation.We randomly assigned 401 patients who were undergoing mitral-valve surgery for degenerative mitral regurgitation to receive a procedure with or without tricuspid annuloplasty (TA). The primary 2-year end point was a composite of reoperation for tricuspid regurgitation, progression of tricuspid regurgitation by two grades from baseline or the presence of severe tricuspid regurgitation, or death.Patients who underwent mitral-valve surgery plus TA had fewer primary-end-point events than those who underwent mitral-valve surgery alone (3.9% vs. 10.2%) (relative risk, 0.37; 95% confidence interval [CI], 0.16 to 0.86; P = 0.02). Two-year mortality was 3.2% in the surgery-plus-TA group and 4.5% in the surgery-alone group (relative risk, 0.69; 95% CI, 0.25 to 1.88). The 2-year prevalence of progression of tricuspid regurgitation was lower in the surgery-plus-TA group than in the surgery-alone group (0.6% vs. 6.1%; relative risk, 0.09; 95% CI, 0.01 to 0.69). The frequencies of major adverse cardiac and cerebrovascular events, functional status, and quality of life were similar in the two groups at 2 years, although the incidence of permanent pacemaker implantation was higher in the surgery-plus-TA group than in the surgery-alone group (14.1% vs. 2.5%; rate ratio, 5.75; 95% CI, 2.27 to 14.60).Among patients undergoing mitral-valve surgery, those who also received TA had a lower incidence of a primary-end-point event than those who underwent mitral-valve surgery alone at 2 years, a reduction that was driven by less frequent progression to severe tricuspid regurgitation. Tricuspid repair resulted in more frequent permanent pacemaker implantation. Whether reduced progression of tricuspid regurgitation results in long-term clinical benefit can be determined only with longer follow-up. (Funded by the National Heart, Lung, and Blood Institute and the German Center for Cardiovascular Research; ClinicalTrials.gov number, NCT02675244.).

Repair of concomitant aortic and mitral valvular disease with involvement of the aortomitral curtain requires a technically complex operation colloquially termed the commando procedure. Surgical outcomes of this procedure are not well described. The objective of this study was to examine outcomes of the commando procedure at our center. We identified all patients undergoing concomitant aortic and mitral valve replacements from 2004-2021. Of 363 patients, 41 underwent reconstruction of the aortomitral curtain. Survival analysis and multivariable modeling were used to examine outcomes and risk factors for mortality. The median age was 52 (IQR 44-71) years. Preoperatively, 4 of 41 (9.8%) patients had renal failure, and 10 of 41 (24.4%) had a stroke. The most common surgical indication was endocarditis in 25 of 41 (61.0%) patients. 25 of 41 (61.0%) patients underwent redo sternotomy, and 23 of 41 (56.1%) had previous prosthetic valves. Operative mortality was 14 of 41 (34.1%), and 8 of 41 (9.5%) patients received a permanent pacemaker. Survival at 1, 3, and 5 years was 55.4% (95% confidence interval (CI), 40.6-75.5%), 50.3% (35.0-72.3%), and 37.7% (19.3-73.9%) respectively. Cox proportional hazards regression identified previous sternotomy (HR 4.76, 95% CI 1.21-18.73), and female gender (HR 1.39, 95% CI 1.17-13.82) as risk factors for mortality. Patients undergoing reconstruction of the aortomitral curtain represent a high-risk population with complex surgical indications. Due to high perioperative morbidity and mortality, this procedure should be performed only when necessary. Despite a high up front morbidity burden, outcomes remain favorable for patients who survive the initial hospitalization.

There are limited therapeutic options for patients with COVID-19-related acute respiratory distress syndrome (ARDS) with inflammation-mediated lung injury. Mesenchymal stromal cells offer promise as immunomodulatory agents.Evaluation of efficacy and safety of allogeneic mesenchymal cells in mechanically-ventilated patients with moderate or severe COVID-induced respiratory failure.Patients were randomized to two infusions of 2 million cells/kg or sham infusions, in addition to standard of care. We hypothesized that cell therapy would be superior to sham-control for the primary endpoint of 30-day mortality. The key secondary endpoint was ventilator-free survival within 60 days, accounting for deaths and withdrawals in a ranked analysis.At the third interim analysis, the Data and Safety Monitoring Board recommended that the trial halt enrollment as the pre-specified mortality reduction from 40% to 23% was unlikely to be achieved (n=222 out of planned 300). Thirty-day mortality was 37.5% (42/112) in cell recipients versus 42.7% (47/110) in control patients (RR 0.88;95% CI 0.64,1.21;p=0.43). There were no significant differences in days alive off ventilation within 60 days (median rank 117.3 [IQR:60.0,169.5] in cell patients and 102.0 [IQR:54.0,162.5] in controls; higher is better). Resolution or improvement of ARDS at 30-days was observed in 51/104 (49.0%) cell recipients and 46/106 (43.4%) of control patients (OR 1.36;95% CI 0.57, 3.21). There were no infusion-related toxicities and overall serious adverse events over 30 days were similar.Mesenchymal cells, while safe, did not improve 30-day survival or 60-day ventilator-free days in patients with moderate/severe COVID-related acute respiratory distress syndrome. Clinical trial registration available at www.gov, ID:NCT04371393. This article is open access and distributed under the terms of the Creative Commons Attribution Non-Commercial No Derivatives License 4.0 (http://creativecommons.org/licenses/by-nc-nd/4.0/).

Whether to repair nonsevere tricuspid regurgitation (TR) during surgery for ischemic mitral valve regurgitation (IMR) remains uncertain.The goal of this study was to investigate the incidence, predictors, and clinical significance of TR progression and presence of ≥moderate TR after IMR surgery.Patients (n = 492) with untreated nonsevere TR within 2 prospectively randomized IMR trials were included. Key outcomes were TR progression (either progression by ≥2 grades, surgery for TR, or severe TR at 2 years) and presence of ≥moderate TR at 2 years.Patients' mean age was 66 ± 10 years (67% male), and TR distribution was 60% ≤trace, 31% mild, and 9% moderate. Among 2-year survivors, TR progression occurred in 20 (6%) of 325 patients. Baseline tricuspid annular diameter (TAD) was not predictive of TR progression. At 2 years, 37 (11%) of 323 patients had ≥moderate TR. Baseline TR grade, indexed TAD, and surgical ablation for atrial fibrillation were independent predictors of ≥moderate TR. However, TAD alone had poor discrimination (area under the curve, ≤0.65). Presence of ≥moderate TR at 2 years was higher in patients with MR recurrence (20% vs. 9%; p = 0.02) and a permanent pacemaker/defibrillator (19% vs. 9%; p = 0.01). Clinical event rates (composite of ≥1 New York Heart Association functional class increase, heart failure hospitalization, mitral valve surgery, and stroke) were higher in patients with TR progression (55% vs. 23%; p = 0.003) and ≥moderate TR at 2 years (38% vs. 22%; p = 0.04).After IMR surgery, progression of unrepaired nonsevere TR is uncommon. Baseline TAD is not predictive of TR progression and is poorly discriminative of ≥moderate TR at 2 years. TR progression and presence of ≥moderate TR are associated with clinical events. (Comparing the Effectiveness of a Mitral Valve Repair Procedure in Combination With Coronary Artery Bypass Grafting [CABG] Versus CABG Alone in People With Moderate Ischemic Mitral Regurgitation, NCT00806988; Comparing the Effectiveness of Repairing Versus Replacing the Heart's Mitral Valve in People With Severe Chronic Ischemic Mitral Regurgitation, NCT00807040).

Risk-adjusted survival after late heart re-transplantation may be comparable to primary transplant, but the efficacy of re-transplantation in older candidates is not established. We evaluated outcomes after heart re-transplantation in recipients60 years.We identified 1026 adult patients undergoing isolated heart re-transplantation between 2003 and 2020 from the United Network for Organ Sharing database. Older recipients (60 years, n=177) were compared to younger recipients (≤ 60 years, n=849). Five and ten-year post-transplant survival was estimated using the Kalpan-Meier method and adjusted with multivariable Cox models.Older recipients were more likely to be male and have diabetes or previous malignancies with higher baseline creatinine. They also more frequently required pre-transplant ECMO (11.9% vs. 6.8%, p=0.02) and received re-transplantation due to primary graft failure (13.6% vs. 8.5%, p=0.03). After the transplant, older recipients had a higher incidence of stroke (6.8% vs. 2.6%, p=0.01) and dialysis requirements (20.3% vs. 13.2%) before discharge (both p0.05), and more frequently died from malignancy-related causes (16.3% vs. 3.9%, p0.001). After adjustment, recipient age60 was associated with an increased risk of both 5-year (HR 1.42, 95% CI 1.02-2.01, p=0.04) and 10-year mortality (HR 1.72, 95% CI 1.20-2.45, p=0.003). Restricted cubic spline showed a non-linear relationship between recipient age and 10-year mortality.Heart re-transplantation in recipients60 years has inferior outcomes compared to younger recipients. Strict patient selection and close follow-up are warranted to ensure the appropriate utilization of donor hearts and to improve long-term outcomes.

BACKGROUND: We aimed to assess the efficacy and safety of two neutralising monoclonal antibody therapies (sotrovimab [Vir Biotechnology and GlaxoSmithKline] and BRII-196 plus BRII-198 [Brii Biosciences]) for adults admitted to hospital for COVID-19 (hereafter referred to as hospitalised) with COVID-19.METHODS: In this multinational, double-blind, randomised, placebo-controlled, clinical trial (Therapeutics for Inpatients with COVID-19 [TICO]), adults (aged ≥18 years) hospitalised with COVID-19 at 43 hospitals in the USA, Denmark, Switzerland, and Poland were recruited. Patients were eligible if they had laboratory-confirmed SARS-CoV-2 infection and COVID-19 symptoms for up to 12 days. Using a web-based application, participants were randomly assigned (2:1:2:1), stratified by trial site pharmacy, to sotrovimab 500 mg, matching placebo for sotrovimab, BRII-196 1000 mg plus BRII-198 1000 mg, or matching placebo for BRII-196 plus BRII-198, in addition to standard of care. Each study product was administered as a single dose given intravenously over 60 min. The concurrent placebo groups were pooled for analyses. The primary outcome was time to sustained clinical recovery, defined as discharge from the hospital to home and remaining at home for 14 consecutive days, up to day 90 after randomisation. Interim futility analyses were based on two seven-category ordinal outcome scales on day 5 that measured pulmonary status and extrapulmonary complications of COVID-19. The safety outcome was a composite of death, serious adverse events, incident organ failure, and serious coinfection up to day 90 after randomisation. Efficacy and safety outcomes were assessed in the modified intention-to-treat population, defined as all patients randomly assigned to treatment who started the study infusion. This study is registered with ClinicalTrials.gov, NCT04501978.FINDINGS: Between Dec 16, 2020, and March 1, 2021, 546 patients were enrolled and randomly assigned to sotrovimab (n=184), BRII-196 plus BRII-198 (n=183), or placebo (n=179), of whom 536 received part or all of their assigned study drug (sotrovimab n=182, BRII-196 plus BRII-198 n=176, or placebo n=178; median age of 60 years [IQR 50-72], 228 [43%] patients were female and 308 [57%] were male). At this point, enrolment was halted on the basis of the interim futility analysis. At day 5, neither the sotrovimab group nor the BRII-196 plus BRII-198 group had significantly higher odds of more favourable outcomes than the placebo group on either the pulmonary scale (adjusted odds ratio sotrovimab 1·07 [95% CI 0·74-1·56]; BRII-196 plus BRII-198 0·98 [95% CI 0·67-1·43]) or the pulmonary-plus complications scale (sotrovimab 1·08 [0·74-1·58]; BRII-196 plus BRII-198 1·00 [0·68-1·46]). By day 90, sustained clinical recovery was seen in 151 (85%) patients in the placebo group compared with 160 (88%) in the sotrovimab group (adjusted rate ratio 1·12 [95% CI 0·91-1·37]) and 155 (88%) in the BRII-196 plus BRII-198 group (1·08 [0·88-1·32]). The composite safety outcome up to day 90 was met by 48 (27%) patients in the placebo group, 42 (23%) in the sotrovimab group, and 45 (26%) in the BRII-196 plus BRII-198 group. 13 (7%) patients in the placebo group, 14 (8%) in the sotrovimab group, and 15 (9%) in the BRII-196 plus BRII-198 group died up to day 90.INTERPRETATION: Neither sotrovimab nor BRII-196 plus BRII-198 showed efficacy for improving clinical outcomes among adults hospitalised with COVID-19.FUNDING: US National Institutes of Health and Operation Warp Speed.

Aberrant subclavian artery (aSCA) is a rare anatomic variant whose association with other aortic branch variations and aortic pathology has yet to be established. Knowledge of such an association could be relevant to recommendations for screening and awareness as associated variations are important for operative planning. We describe the incidence of aSCA variations, its association with aortic pathology, and a proposed classification system.The thoracic cross-sectional imaging database at Keck Hospital of the University of Southern California from 2006 to 2018 was queried for presence of aSCA. Studies were evaluated for aSCA laterality, variant anatomy, and aortic and branch vessel disease. Medical records were reviewed for associated symptoms and diagnoses. The primary outcome was association of aSCA with aortic pathology (aneurysm or dissection). Secondary outcomes were comparison of right and left aSCA, comparison between the sexes, and creation of a proposed classification system.Of 98,580 axial imaging studies, 810 studies (0.82%) were identified with aSCA in 312 unique patients. Right aSCA made up the majority of cases (90.1%). All aSCAs had a retroesophageal course. Kommerell's diverticulum (KD) was present in 184 (59%) with an average diameter of 1.67 cm (range, 1.2-3.3 cm). KD was more frequent (84% vs 56%; P = .0003) and larger (2.05 cm vs 1.61 cm; P .0001) in left aSCA patients. When present, KD was more often symptomatic in left aSCA compared with right aSCA (77.4% vs 49.1%; P = .005). Dysphagia, chest pain, reflux, and asthma were all more common in left aSCA patients. KD was also more common in men (73.3% vs 50%; P .0001) and larger in men (1.81 cm vs 1.54 cm; P .0001) but with no difference in symptoms between sexes. Our proposed classification system based on aortic arch branching is as follows: type 1, left arch with right aSCA (59.9%); type 2, left arch with common carotid trunk and right aSCA (30.1%); type 3, right arch with left aSCA (9.6%); and type 4, right arch with common carotid trunk and left aSCA (0.3%). Subtypes describe the right vertebral artery (RVA) and left vertebral artery (LVA) origin: subclavian (s, RVA 90.1%, LVA 96.8%), carotid (c, RVA 9.6%, LVA 0.3%), or arch (a, RVA 0.3%, LVA 2.9%). Overall, 9.9% (31/312) had associated aortic pathology, although the study was underpowered to detect a difference between right aSCA and left aSCA (9.3% vs 16.1%; P = .213). Type 3 and type 4 arches more often have associated aortic pathology, KD, and symptoms.aSCAs are frequently symptomatic and commonly associated with aortic dissection and aneurysm. Our proposed classification scheme depicts all four aSCA arch variants and accounts for vertebral artery origin variation. These variants are common, and vertebral anatomy can differ greatly. Knowledge of these anatomic variations is critical to planning for endovascular and open repair of aortic arch pathology.

The Society of Thoracic Surgeons Adult Cardiac Surgery Database is the most mature and comprehensive database in cardiac surgery and one of the most respected clinical data registries in health care. It is widely acknowledged for accurately benchmarking risk-adjusted outcomes and serving as the foundation for quality measurement and improvement activities in cardiac surgery. In addition, the database is a valuable resource for novel research. The advent of the database's fourth decade in operation is being heralded with major revisions to its functionality, ease of use, and value to multiple stakeholders. This report is the fifth in a series of annual reports that provides updated national outcomes, volume trends, and database-related developments, as well as a summary of research performed in the past year using data from this valuable repository on quality and performance improvement.

National registry data show wide variability in degenerative mitral repair rates and infrequent use of intraoperative repair revision to eliminate residual mitral regurgitation (MR). The consequence of uncorrected mild residual MR is also not clear. We identified factors associated with intraoperative revision of degenerative mitral repair and evaluated long-term effects of intraoperative mild residual MR.A prospective institutional registry of 858 patients with degenerative MR undergoing robotic mitral surgery was linked to statewide databases. Univariate logistic regression identified factors associated with intraoperative repair revision. Survival was estimated using the Kaplan-Meier method and adjusted with Cox regression. Late freedom from more-than-moderate MR or reintervention was estimated with death as a competing risk.Repair rate was 99.3%. Repair was revised intraoperatively in 19 patients and was associated with anterior or bileaflet prolapse, adjunctive repair techniques, and annuloplasty band size (all P .05). Intraoperative repair revision did not result in increased postoperative complications. Intraoperative mild residual MR (n = 111) was independently associated with inferior 8-year survival (hazard ratio, 2.97; 95% CI, 1.33-6.23), worse freedom from more than moderate MR (hazard ratio, 3.35; 95% CI, 1.60-7.00), and worse freedom from mitral reintervention (hazard ratio, 6.40; 95% CI, 2.19-18.72) (all P .01).A near 100% repair rate with acceptable durability may be achieved safely with intraoperative revision of postrepair residual MR. Mild residual MR was independently associated with reduced survival, worse freedom from more-than-moderate MR, and worse freedom from mitral reintervention at 8-year follow-up.

The effects of stroke and delirium on postdischarge cognition and patient-centered health outcomes after surgical aortic valve replacement (SAVR) are not well characterized. Here, we assess the impact of postoperative stroke and delirium on these health outcomes in SAVR patients at 90 days.Patients (N = 383) undergoing SAVR (41% received concomitant coronary artery bypass graft) enrolled in a randomized trial of embolic protection devices underwent serial neurologic and delirium evaluations at postoperative days 1, 3, and 7 and magnetic resonance imaging at day 7. Outcomes included 90-day functional status, neurocognitive decline from presurgical baseline, and quality of life.By postoperative day 7, 25 (6.6%) patients experienced clinical stroke and 103 (28.5%) manifested delirium. During index hospitalization, time to discharge was longer in patients experiencing stroke (hazard ratio, 0.62; 95% confidence interval [CI], 0.42-0.94; P = .02) and patients experiencing delirium (hazard ratio, 0.68; 95% CI, 0.54-0.86; P = .001). At day 90, patients experiencing stroke were more likely to have a modified Rankin score2 (odds ratio [OR], 5.9; 95% CI, 1.7-20.1; P = .01), depression (OR, 5.3; 95% CI, 1.6-17.3; P = .006), a lower 12-Item Short Form Survey physical health score (adjusted mean difference -3.3 ± 1.9; P = .08), and neurocognitive decline (OR, 7.8; 95% CI, 2.3-26.4; P = .001). Delirium was associated with depression (OR, 2.2; 95% CI, 0.9-5.3; P = .08), lower 12-Item Short Form Survey physical health (adjusted mean difference -2.3 ± 1.1; P = .03), and neurocognitive decline (OR, 2.2; 95% CI, 1.2-4.0; P = .01).Stroke and delirium occur more frequently after SAVR than is commonly recognized, and these events are associated with disability, depression, cognitive decline, and poorer quality of life at 90 days postoperatively. These findings support the need for new interventions to reduce these events and improve patient-centered outcomes.

BACKGROUND: In a randomized, placebo-controlled, clinical trial, bamlanivimab, a SARS-CoV-2-neutralizing monoclonal antibody, given in combination with remdesivir, did not improve outcomes among hospitalized patients with COVID-19 based on an early futility assessment.OBJECTIVE: To evaluate the a priori hypothesis that bamlanivimab has greater benefit in patients without detectable levels of endogenous neutralizing antibody (nAb) at study entry than in those with antibodies, especially if viral levels are high.DESIGN: Randomized, placebo-controlled trial. (ClinicalTrials.gov: NCT04501978).SETTING: Multicenter trial.PATIENTS: Hospitalized patients with COVID-19 without end-organ failure.INTERVENTION: Bamlanivimab (7000 mg) or placebo.MEASUREMENTS: Antibody, antigen, and viral RNA levels were centrally measured on stored specimens collected at baseline. Patients were followed for 90 days for sustained recovery (defined as discharge to home and remaining home for 14 consecutive days) and a composite safety outcome (death, serious adverse events, organ failure, or serious infections).RESULTS: Among 314 participants (163 receiving bamlanivimab and 151 placebo), the median time to sustained recovery was 19 days and did not differ between the bamlanivimab and placebo groups (subhazard ratio [sHR], 0.99 [95% CI, 0.79 to 1.22]; sHR > 1 favors bamlanivimab). At entry, 50% evidenced production of anti-spike nAbs; 50% had SARS-CoV-2 nucleocapsid plasma antigen levels of at least 1000 ng/L. Among those without and with nAbs at study entry, the sHRs were 1.24 (CI, 0.90 to 1.70) and 0.74 (CI, 0.54 to 1.00), respectively (nominal P for interaction = 0.018). The sHR (bamlanivimab vs. placebo) was also more than 1 for those with plasma antigen or nasal viral RNA levels above median level at entry and was greatest for those without antibodies and with elevated levels of antigen (sHR, 1.48 [CI, 0.99 to 2.23]) or viral RNA (sHR, 1.89 [CI, 1.23 to 2.91]). Hazard ratios for the composite safety outcome (LIMITATION: Subgroup analysis of a trial prematurely stopped because of futility; small sample size; multiple subgroups analyzed.CONCLUSION: Efficacy and safety of bamlanivimab may differ depending on whether an endogenous nAb response has been mounted. The limited sample size of the study does not allow firm conclusions based on these findings, and further independent trials are required that assess other types of passive immune therapies in the same patient setting.PRIMARY FUNDING SOURCE: U.S. government Operation Warp Speed and National Institute of Allergy and Infectious Diseases.

Single-center studies have demonstrated excellent results for the Ross procedure in children. We aimed to evaluate national variation in clinical outcomes using The Society of Thoracic Surgeons Congenital Heart Surgery Database.The database was used to identify 2805 children undergoing the Ross procedure from 2000 through 2018, comprising 163 neonates (30 days, 5.8%), 448 infants (30-365 days, 16.0%), 1444 children (1-12 years, 51.5%), and 750 teenagers (13-17 years, 26.7%). Centers were divided into terciles by procedural volume. Multivariable logistic regression was used to identify predictors of a composite outcome of operative mortality, neurologic deficit, or renal failure requiring dialysis.Neonates and infants were more likely to present with aortic stenosis than children and teenagers (61.7% [n = 377] vs 34.6% [n = 760]; P.01) and have risk factors including preoperative shock (9.2% [n = 56] vs 0.4% [n = 8]; P.01). Operative mortality was 24.1% (n = 39) in neonates, 11.2% (n = 50) in infants, 1.5% (n = 21) in children , and 0.8% (n = 6) in teenagers (P.01). Independent predictors of the composite outcome in children aged1 year included neonatal age (odds ratio [OR], 3.0; 95% CI, 1.9-4.8), low-volume center (OR, 2.1; 95% CI, 1.1-3.9), and procedure year (OR, 0.7; 95% CI, 0.5-0.9 per 5 years). In children aged ≥1 year, no association was found between center volume, procedure year, and outcome.The Ross procedure is being performed with low mortality in children aged ≥1 year throughout North America. High-volume centers have improved outcomes in children aged1 year, who have different anatomic characteristics and risk profiles.

Objective To compare outcomes with wrapped (pulmonary autograft inclusion) versus unwrapped techniques in adults with bicuspid aortic valves undergoing the Ross procedure. Methods Between 1992 and 2019, 129 adults with bicuspid aortic valves (aged ≥18 years) underwent the Ross procedure by a single surgeon. Patients were divided into those without autograft inclusion (unwrapped, n = 71) and those with autograft inclusion (wrapped, n = 58). Median follow-up was 10.3 years (interquartile range, 3.0-16.8 years). Need for autograft reintervention was analyzed using competing risks. Results Pre- and intraoperative characteristics as well as 30-day morbidity or mortality did not differ between cohorts. Survival at 1, 5, and 10 years, respectively, was 97.2%, 97.2%, and 95.6% in the unwrapped cohort and 100%, 100%, and 100% in the wrapped cohort (P = .15). Autograft valve failure occurred in 25 (35.2%) of the unwrapped and 3 (5.2%) of the wrapped patients. Competing risks analysis demonstrated the wrapped cohort to have a lower need for autograft reintervention (subhazard ratio, 0.28, 95% confidence interval, 0.08-0.91; P = .035). The cumulative incidence of autograft reintervention (death as a competing outcome) at 1, 5, and 10 years, respectively, was 10.2%, 14.9%, and 26.8% in the unwrapped cohort and 4.0%, 4.0%, and 4.0% in the wrapped cohort. Conclusions In adults with bicuspid aortic valves, the Ross procedure with pulmonary autograft inclusion stabilizes the aortic root preventing dilatation and reduces the need for reoperation. The autograft inclusion technique allows the Ross procedure to be performed in this population with excellent long-term outcomes.

OBJECTIVES: To compare outcomes after the development of early (≤30 days) versus delayed (>30 days) deep sternal wound infection (DSWI) after cardiac surgery. METHODS: Between 2005 and 2016, 64 patients were treated surgically for DSWI following cardiac surgery. Thirty-three developed early DSWI, while 31 developed late DSWI. Mean follow up was 34.1 ± 32.3 months. RESULTS: Survival for the entire cohort at 1, 3, and 5 years was 93.9, 85.1, and 80.8%, respectively. DSWI diagnosed early and attempted medical management were strongly associated with overall mortality (hazard ratio (HR), 25.0 and 9.9; 95% confidence intervals (CI), 1.18–528 and 1.28–76.5; p-value 0.04 and 0.04, respectively). Survival was 88.1, 77.0, 70.6 and 100, 94.0 and 94.0% at 1,3, and 5 years in the early and late DSWI groups, respectively (Log-rank = 0.074). Those diagnosed early were more likely to have a positive wound culture (odds ratio (OR), 0.06, 95% CI 0.01–0.69, p=0.024) and diagnosed late were more likely to be female (OR 8.75, 95% CI 2.0–38.4, p=0.004) and require an urgent DSWI procedure (OR 9.25, 95% CI 1.86–45.9, p=0.007). Both early diagnosis of DSWI and initial attempted medial management were strongly associated with mortality (hazard ratio 7.48, 95% CI 1.38–40.4, p=0.019 and hazard ratio 7.76, 95% CI 1.67–35.9, p=0.009, respectively). CONCLUSIONS: Early aggressive surgical therapy for deep sternal wound infection after cardiac surgery results in excellent outcomes. Those diagnosed with DSWI early and have failed initial medical management have increased mortality.

Background: Beginning on March 16, 2020, nonurgent scheduled operations at a large, urban, safety net medical center were canceled. The purpose of this study was to determine complications associated with severe acute respiratory syndrome coronavirus 2 infection for all operations done from March 16 to June 30, 2020. Study Design: This study was a single-institution, retrospective observational analysis of data for all surgical procedures and all severe acute respiratory syndrome coronavirus 2 tests done in the medical center from March 16 to June 30, 2020. The charts of all severe acute respiratory syndrome coronavirus 2–positive patients who had a surgical procedure during the study time period were retrospectively reviewed to assess the outcomes. Results: Of 2,208 operations during that time, 29 (1.3%) patients were severe acute respiratory syndrome coronavirus 2–positive and were asymptomatic at the time of their operations. Twenty-four (82.7%) of the 29 required urgent or emergent procedures. The median time between availability of test results and operations for these patients was 0.63 + 1.94 days. With median follow-up of 89 days, none of the 29 patients died from severe acute respiratory syndrome coronavirus 2–related causes, and none developed clinically evident thromboembolism or required reintubation secondary to severe acute respiratory syndrome coronavirus 2–related pneumonia. Conclusion: By operating on carefully screened, asymptomatic severe acute respiratory syndrome coronavirus 2–positive patients, it was possible to eliminate major complications and mortality due to severe acute respiratory syndrome coronavirus 2 infection.

The Society of Thoracic Surgeons (STS) original coronary artery bypass graft surgery (CABG) composite measure uses a 1-year analytic cohort and 98% credible intervals (CrI) to classify better than expected (3-star) performance or worse than expected (1-star) performance. As CABG volumes per STS participant (eg, hospital or practice group) have decreased, it has become more challenging to classify performance categories using this approach, especially for lower volume programs, and alternative approaches have been explored.Among 990 STS Adult Cardiac Surgery Database participants, performance classifications for the CABG composite were studied using various analytic cohorts: 1 year (current approach, 2017); 3 years (2015 to 2017); last 450 cases within 3 years; and most recent year (2017) plus additional cases to 450 total. We also compared 98% CrI with 95% CrI (used in other STS composite measures).Using 3 years of data and 95% CrIs, 113 of 990 participants (11.4%) were classified 1-star and 198 (20%) 3-star. Compared with 1-year analytic cohorts and 98% CrI, the absolute and relative increases in the proportion of 3-star participants were 14 percentage points and 233% (n = 198 [20%] vs n = 59 [6%]). Corresponding changes for 1-star participants were 6.5 percentage points and 133% (n = 113 [11.4%] vs n = 48 [4.9%]). These changes were particularly notable among lower volume (fewer than 199 CABG per year) participants. Measure reliability with the 3-year, 95% CrI modification is 0.78.Compared with current STS CABG composite methodology, a 3-year analytic cohort and 95% CrI increases the number and proportion of better or worse than expected outliers, especially among lower-volume Adult Cardiac Surgery Database participants. This revised methodology is also now consistent with other STS procedure composites.

Background Debate continues in regard to the optimal surgical approach to the mitral valve for degenerative disease. Methods Between February 2004 and July 2015, 363 patients underwent mitral valve repair for degenerative mitral valve disease via either sternotomy (sternotomy, n = 109) or small right anterior thoracotomy (minimally invasive, n = 259). Survival, need for mitral valve reoperation, and progression of mitral regurgitation more than two grades were compared between cohorts using time-based statistical methods and inverse probability weighting. Results Survival at 1, 5, and 10 years were 99.2, 98.3, and 96.8 for the sternotomy group and 98.1, 94.9, and 94.9 for the minimally invasive group (hazard ratio: 0.39, 95% confidence interval [CI] 0.11-1.30, p = .14). The cumulative incidence of need for mitral valve reoperation with death as a competing outcome at 1, 3, and 5 years were 2.7%, 2.7%, and 2.7% in the sternotomy cohort and 1.5%, 3.3%, and 4.1% for the minimally invasive group (subhazard ratio (SHR) 1.17, 95% CI: 0.33-4.20, p = .81). Cumulative incidence of progression of mitral regurgitation more than two grades with death as a competing outcome at 1, 3, and 5 years were 5.5%, 14.4%, and 44.5% for the sternotomy cohort and 4.2%, 9.7%, and 20.5% for the minimally invasive cohort (SHR: 0.67, 95% CI: 0.28-1.63, p = .38). Inverse probability weighted time-based analyses based on preoperative cohort assignment also demonstrated equivalent outcomes between surgical approaches. Conclusions Minimally invasive and sternotomy mitral valve repair in patients with degenerative mitral valve disease is associated with equivalent survival and repair durability.

The Society of Thoracic Surgeons Adult Cardiac Surgery Database is the most mature and comprehensive cardiac surgery database. It has been the foundation for quality measurement and improvement activities in cardiac surgery, facilitated the generation of accurate risk adjusted performance benchmarks and serves as a platform for novel research. Recent enhancements have added to the database's functionality, ease of use, and value to multiple stakeholders. This report is the sixth in a series of annual reports that provide updated volumes, outcomes, database-related developments, quality improvement initiatives, and research summaries using the Adult Cardiac Surgery Database in the past year.

Graphical abstract A retrospective cohort study was conducted in which 129 adult patients with bicuspid aortic valves underwent the Ross procedure with either a standard root inclusion technique or a modified technique whereby the pulmonary autograft is wrapped in a vascular conduit. Primary outcomes were survival and the need for pulmonary autograft reintervention. Competing risk analysis demonstrated the wrapped technique reduced pulmonary autograft reintervention.

BACKGROUND: LY-CoV555, a neutralizing monoclonal antibody, has been associated with a decrease in viral load and the frequency of hospitalizations or emergency department visits among outpatients with coronavirus disease 2019 (Covid-19). Data are needed on the effect of this antibody in patients who are hospitalized with Covid-19.METHODS: In this platform trial of therapeutic agents, we randomly assigned hospitalized patients who had Covid-19 without end-organ failure in a 1:1 ratio to receive either LY-CoV555 or matching placebo. In addition, all the patients received high-quality supportive care as background therapy, including the antiviral drug remdesivir and, when indicated, supplemental oxygen and glucocorticoids. LY-CoV555 (at a dose of 7000 mg) or placebo was administered as a single intravenous infusion over a 1-hour period. The primary outcome was a sustained recovery during a 90-day period, as assessed in a time-to-event analysis. An interim futility assessment was performed on the basis of a seven-category ordinal scale for pulmonary function on day 5.RESULTS: On October 26, 2020, the data and safety monitoring board recommended stopping enrollment for futility after 314 patients (163 in the LY-CoV555 group and 151 in the placebo group) had undergone randomization and infusion. The median interval since the onset of symptoms was 7 days (interquartile range, 5 to 9). At day 5, a total of 81 patients (50%) in the LY-CoV555 group and 81 (54%) in the placebo group were in one of the two most favorable categories of the pulmonary outcome. Across the seven categories, the odds ratio of being in a more favorable category in the LY-CoV555 group than in the placebo group was 0.85 (95% confidence interval [CI], 0.56 to 1.29; P = 0.45). The percentage of patients with the primary safety outcome (a composite of death, serious adverse events, or clinical grade 3 or 4 adverse events through day 5) was similar in the LY-CoV555 group and the placebo group (19% and 14%, respectively; odds ratio, 1.56; 95% CI, 0.78 to 3.10; P = 0.20). The rate ratio for a sustained recovery was 1.06 (95% CI, 0.77 to 1.47).CONCLUSIONS: Monoclonal antibody LY-CoV555, when coadministered with remdesivir, did not demonstrate efficacy among hospitalized patients who had Covid-19 without end-organ failure. (Funded by Operation Warp Speed and others; TICO ClinicalTrials.gov number, NCT04501978.).