OBJECTIVE:To assess outcomes with perioperative durvalumab by type of surgery in patients with resectable non-small cell lung cancer (NSCLC) from the AEGEAN study. METHODS:AEGEAN is a double-blind, placebo-controlled phase 3 study (NCT03800134) of adults with treatment-naïve, resectable NSCLC (stage II-IIIB[N2]) who were randomized 1:1 to neoadjuvant chemotherapy plus durvalumab or placebo before surgery followed by adjuvant durvalumab or placebo. PRIMARY ENDPOINTS:pathological complete response (pCR) and event-free survival (EFS) in the modified intent-to-treat (mITT) population, which excluded patients with documented EGFR/ALK aberrations. RESULTS:Of 295 and 302 patients in the durvalumab and placebo arms, respectively, who underwent surgery (mITT population), 80.7% versus 73.2% had lobectomy, 7.5% versus 12.3% had sleeve resection/bilobectomy, and 9.2% versus 9.6% had pneumonectomy. pCR rates were higher in the durvalumab versus placebo arm, regardless of surgery type (lobectomy: 21.0% vs 5.4%; sleeve resection/bilobectomy: 36.4% vs 5.4%; and pneumonectomy: 7.4% vs 3.4%). EFS benefit favored the durvalumab versus placebo arm, regardless of surgery type (lobectomy: hazard ratio [HR], 0.64 [95% confidence interval (CI), 0.46-0.88; sleeve resection/bilobectomy: HR, 0.59 [95% CI, 0.22-1.40]; and pneumonectomy: HR, 0.80 [95% CI, 0.36-1.74]). The rates of maximum grade ≥3 surgical complications were low across both arms, regardless of surgery type (lobectomy: 4.2% vs 9.5%; sleeve resection/bilobectomy: 13.6% vs 5.4%; and pneumonectomy: 14.8% vs 6.9%). CONCLUSIONS:Clinical benefit with perioperative durvalumab plus neoadjuvant chemotherapy versus neoadjuvant chemotherapy alone was generally maintained across the surgery subgroups.
Objectives The Ross procedure provides excellent long-term survival and hemodynamics in young adults, but its role in older patients remains undefined. Current guidelines and the recent European Association for Cardio-Thoracic Surgery consensus limit recommendations to patients <60 years. We aimed to compare outcomes after the Ross procedure in patients ≥60 versus <60 years. Methods Between 2011 and 2024, 882 consecutive patients underwent the Ross procedure at 2 high-volume centers in Canada. Of these, 134 (15.2%) were ≥60 years (mean 62 ± 2 years) and 748 (84.8%) were <60 years (mean 46 ± 11 years). Outcomes were assessed with overlap-weighted analyses, adjusted for baseline characteristics. Results Before weighting, older patients had greater rates of hypertension, dyslipidemia, and chronic kidney disease and were more likely to have bicuspid valves, whereas younger patients more frequently presented with aortic regurgitation, unicuspid valve, and previous redo surgeries. After overlap weighting, all variables included in the model achieved excellent balance. Thirty-day mortality was low and comparable (0.9% ≥60 vs 0.5% <60, P = .49). Major perioperative complications were comparable. Median follow-up was 6.1 versus 4.7 years (P = .009). Survival at 9 years was 93.9% in ≥60 versus 97.1% in <60 (log-rank P = .98), both approximating the age- and sex-matched Canadian population. There were no valve-related deaths at follow-up. The 9-year cumulative incidence of all-cause reintervention was low and comparable (7.0% vs 3.9%, P = .42). Hemodynamic performance remained excellent in both groups. Conclusions The Ross procedure is safe in carefully selected patients ≥60 years, with excellent survival and valve durability up to 10 years, comparable with younger patients. In expert centers, extending the Ross beyond 60 years may represent a valid alternative within lifetime management strategies.
OBJECTIVE:To evaluate the relative influence of surgeon- and center-level mitral valve repair volume with repair utilization and early outcomes among adults undergoing isolated surgery for primary mitral regurgitation. METHODS:Using the Michigan Society of Thoracic and Cardiovascular Surgeons Quality Collaborative (March 2011- March 2025), we identified adults undergoing isolated mitral valve surgery for primary mitral regurgitation. High-volume centers (>50 repairs annually) and high-volume surgeons (>25 repair over two consecutive years) were identified. The primary outcome was mitral valve repair versus replacement. Secondary outcomes included operative times and selected early postoperative outcomes. RESULTS:Among 6,649 mitral valve surgery patients, the repair rate was 80% (n = 5,329). Only 3 (9%) of 33 centers and 6 (3.8%) of 146 surgeons were high-volume. High-volume centers had higher observed repair rates (87%, n = 3,027 vs 73%, n = 2,302), non-significant after adjustment (odd ratios: 1.23, 95% confidence interval: 0.61-2.45; p = .56). High-volume surgeons had higher adjusted repair rates (93%, n = 2,613 vs 70%, n = 2,716; odd ratio (95% confidence interval): 1.45(1.1-1.9), p = .003), shorter median cross-clamp times (75 min, interquartile range (55-111) vs 91 min, (71-117), p = .001), and had lower permanent pacemaker implantation rates (1.0%, vs 3.0%, p < .001). CONCLUSIONS:In contradistinction to high-volume, higher surgeon-level mitral repair volume remained associated with greater repair utilization. Moreover, high vs low volume surgeons had shorter operative times, and fewer selected early postoperative complications.
BACKGROUND:This post hoc analysis of the Posterior Left Pericardiotomy for the Prevention of AtriaL Fibrillation After Cardiac Surgery (PALACS) trial examined the association between sex and postoperative atrial fibrillation characteristics after cardiac surgery. METHODS:In PALACS, patients undergoing cardiac surgery were randomized to posterior left pericardiotomy or no intervention. This analysis stratified participants by sex, evaluating differences in postoperative atrial fibrillation incidence, duration, burden, postoperative in-hospital length of stay, and pericardial effusions. RESULT:All 420 PALACS patients were included, consisting of 24% (102/420) female patients. Postoperative atrial fibrillation occurred in 22% (22/102) of female patients and 25% (81/318) of male patients (P = .51). Female sex was associated with a lower postoperative atrial fibrillation risk (adjusted odds ratio, 0.47, 95% CI, 0.24-0.87, P = .02). Posterior left pericardiotomy reduced the risk of postoperative atrial fibrillation (adjusted odds ratio, 0.46 95% CI, 0.28-0.76, P = .003), without difference by sex (pinteraction = .59). No sex differences were observed in postoperative atrial fibrillation duration or burden. Female patients had longer postoperative in-hospital length of stay (median 7 [interquartile range, 5-8] days vs 6 [interquartile range, 5-7] days, P = .005); however, sex was not independently associated with hospitalization length (adjusted β 1079, 95% CI, -448 to 2605, P = .17). Pericardial effusion incidence and size did not differ by sex. Moderate (>10 mm) posterolateral pericardial effusion was associated with higher postoperative atrial fibrillation incidence (adjusted odds ratio, 2.98, 95% CI, 1.07-8.16, P = .03), without sex difference (pinteraction = .61). CONCLUSIONS:In PALACS, female patients had a lower adjusted risk of postoperative atrial fibrillation; however, the clinical course of postoperative atrial fibrillation was similar between sexes. Posterior left pericardiotomy reduced postoperative atrial fibrillation incidence without evidence of sex-specific heterogeneity.
Objective Predicting postoperative deterioration following cardiac surgery remains challenging. Conventional risk scores rely on static variables and fail to capture evolving physiologic trajectories. We developed a time-series deep learning model (DLM) using serial ICU measurements to dynamically predict mortality and continuous renal replacement therapy (CRRT) after cardiac surgery. Methods Using the Medical Information Mart for Intensive Care database, we analyzed ICU admissions from patients undergoing CABG, isolated or combined with valve surgery, from 2008-2019. Data were split into 70:20:10 training, validation, and testing. Recurrent neural network models were developed to predict in-hospital mortality and CRRT requirement using fixed and dynamic variables. Fixed variables included demographics, comorbidities, and procedure type. Dynamic variables comprised hourly ICU data (vitals, ventilation, vasopressors, and labs). Risk was updated at each timestep by considering the most recent measurements, and a self-attention layer highlighted influential time points. Results Of the 7,402 patients included, 1.3% died in-hospital and 1.8% required CRRT. Utilizing full ICU sequences, the DLMs achieved an AUPRC of 0.877 and 0.906, and F1-scores of 0.808 and 0.757 for mortality and CRRT prediction, respectively. Simulating real-world deployment with hourly, updated predictions, model performance improved as physiologic data accumulated. Furthermore, the self-attention layer highlighted critical timepoints driving predictions, offering valuable clinical interpretability. Conclusions This is first time-series DLM to provide continuously updated, hourly predictions of both mortality and CRRT for cardiac surgery ICU patients, demonstrating high performance and interpretability. By reliably identifying high-risk patients several days before overt deterioration, this approach may facilitate earlier, proactive clinical intervention.
Objective Late Fontan failure and attrition is an increasingly prevalent problem for which there is no primary therapy. A Fontan circulation is a circulation that lacks a subpulmonary pump. We are developing a technology that can safely and reliably restore subpulmonary pump function in a Fontan circulation to reverse the Fontan paradox and maintain normal circulatory health. Methods A rotary pump scaled for adolescent and adult use was developed for implantation to physiologically augment flow in the total cavopulmonary connection (TCPC). Design objectives include 30/70% SVC/IVC inflow draw over a broad range of performance, and no obstruction in the event of device failure. Hydrodynamic and hemodynamic performance were characterized in vitro in a Fontan mock circulatory loop using blood analog. Hemolysis was characterized in blood. Results The pump augments TCPC flow (SVC/IVC inflow; LPA/RPA outflow) at +6-10 mmHg, ranging to +18 mmHg at 3K RPM. Performance is consistent over a wide range of cardiac output. Power requirement is low (1W) at +6 mmHg pressure rise. Hemolysis is comparable to other commercially available pumps. Cavitation or suction was not observed. In the stalled condition (0 RPM), gradient is ≤1 mmHg. Conclusions A Fontan pump can safely reverse the Fontan paradox. Features include a fail-safe contingency that is clinically manageable. The technology may prevent progression of Fontan failure in the setting of preserved systemic ventricular systolic function. As a surgical strategy of long-term biventricular health maintenance, it may improve quality and duration of life for patients with single ventricle heart disease.
OBJECTIVES:Allocation out-of-sequence (AOOS) is an allocation pathway that allows organ procurement organizations (OPOs) to bypass the standard match-run sequence to expedite organ placement and avoid organ wastage amidst donor, recipient, or logistical constraints. Amidst increasing use of AOOS in recent years, we sought to characterize its impact on lung utilization in the contemporary era. METHODS:We performed a retrospective analysis using United Network for Organ Sharing data from June 2021 to December 2024 to examine the association between OPO-level AOOS and lung nonuse. RESULTS:Among 10,350 lung donors, 931 (9.0%) were allocated out-of-sequence, with OPO-level rates of AOOS ranging from 1.2% to 28.9%. Observed-to-expected lung yield ratios were comparable across OPOs stratified by AOOS use, with no significant difference among low-, medium-, and high-AOOS groups (0.96 vs 0.97 vs 0.92; p=0.728). Among 20,462 individual lungs recovered for transplantation, 2,003 (9.8%) ultimately not used. After adjusting for donor characteristics and temporal trends, AOOS was not significantly associated with lung nonuse (incidence rate ratio 1.00, 95% confidence interval 0.94-1.06, p=0.883). CONCLUSION:These findings indicate that further revision of lung allocation policy is required to optimize lung utilization and mitigate use of alternative allocation pathways.
OBJECTIVE:To investigate the outcomes of pediatric patients requiring extracorporeal membrane oxygenation (ECMO) after the Fontan operation. METHODS:We conducted a retrospective cohort analysis of the Extracorporeal Life Support Organization registry, including patients <18 years who underwent ECMO after Fontan palliation from 2010 to 2023. Patients undergoing a first ECMO run during their hospitalization for Fontan surgery were included. RESULTS:Among 281 children undergoing ECMO after Fontan palliation, survival at hospital discharge was 48.4%. Median age and weight were 3.9 years (interquartile range [IQR], 2.7-5.5) and 15 kg (IQR, 12-19), respectively. Venoarterial ECMO was used in 92% of patients, multiple drainage cannulas in 21%, central cannulation in 49%, and Fontan pathway decompression in 51%. Survival did not differ according to the use of multiple drainage cannulas or decompression strategy. Independent predictors of hospital mortality included pre-ECMO arrest (odds ratio [OR], 1.88; P = .042), pre-ECMO bicarbonate administration (OR, 2.01; P = .019), higher ECMO flow at 4 hours (OR, 1.01; P = .014), longer ECMO duration (OR, 1.09; P = .002), longer admission-to-cannulation time (OR, 1.04; P = .002), and neurologic (OR, 5.99; P < .001), renal (OR, 2.92; P = .005), or pulmonary complications (OR, 13.07; P = .022). Eight patients were transitioned to ventricular assist device support after ECMO, and 6 underwent heart transplantation; survival in both groups was 50%. CONCLUSIONS:Hospital survival after ECMO following Fontan palliation has improved compared with prior reports. The avoidance of pre-ECMO arrest and earlier cannulation are potentially modifiable factors that may improve outcomes for these patients. Prospective studies are warranted to better define the timing, outcomes, and optimal support strategies in this population.
OBJECTIVES:Informed by longitudinal epidemiologic evidence regarding postoperative infection rates, this study associated hospital infection rates with 180-day Medicare spending. METHODS:This study analyzed 100% Medicare claims for beneficiaries undergoing cardiac surgery between January 2018 and June 2023. Hospitals were categorized into terciles of 180-day postoperative inpatient infection rates (ie, urinary tract infection, pneumonia, sepsis, Clostridioides difficile colitis, diverticulitis, cholecystitis, bloodstream infection, cellulitis, sternal wound infection, and endocarditis). Adjusted infection counts were estimated using Poisson regression accounting for patient and procedural characteristics, hospital volume, follow-up time, and clustering within hospitals. The primary outcome was hospital 180-day inflation-adjusted (2023 USD) Medicare spending. Secondary outcomes included mortality, readmission, stroke, and respiratory failure. RESULTS:Among 239,039 procedures at 1007 hospitals, the mean (SD) age was 74.2 (5.3) years; 29.0% were female, 87.1% White, and 3.9% African American. Infections occurred in 20.8% of procedures. The adjusted infection rate was 24.7 per 100 patient-months (95% CI, 23.8-25.6), varying across hospital terciles: low 18.6 (95% CI, 17.0-19.0), middle 24.1 (95% CI, 22.4-25.4), and high 40.8 (95% CI, 38.2-44.5) per 100 patient-months (P < .0001). Procedures at high versus low infection-rate hospitals were associated with greater mean spending (+$15,757; 95% CI, $15,169-$16,345). Infection rates explained 23.6% of variation in spending. If middle- and high-tercile hospitals achieved infection rates similar to those observed in the lowest tercile, benchmarking projections estimated approximately 2603 fewer infections and $441M in potentially avoidable annual Medicare payments. CONCLUSIONS:Hospital infection rates are strongly associated with greater Medicare spending and worse outcomes. Reducing infections may offer opportunities to improve outcomes and reduce health care spending.
OBJECTIVE:A simplified mitral valve transcatheter edge-to-edge repair workflow under sole transesophageal echocardiographic guidance, without fluoroscopy, has been developed. This study aimed to compare its real-world outcomes with the conventional procedures under the combined guidance of fluoroscopy and transesophageal echocardiography. METHODS:We retrospectively analyzed 386 patients undergoing mitral valve transcatheter edge-to-edge repair between January 2021 and December 2025, including 286 in the sole transesophageal echocardiography guidance group and 100 in the combined guidance group. The primary end points were cardiovascular mortality, all-cause mortality, and a composite of all-cause mortality and heart failure hospitalization. Propensity score matching and overlap weighting were performed as sensitivity analyses. RESULTS:Technical success was achieved in 98.3% and 97.0% of patients in the sole transesophageal echocardiography group and combined guidance group, respectively, and 30-day major adverse events occurred in 2.8% and 7.0%, respectively (P > .05). The median follow-up was 16.5 months. At 1 year, the estimated cumulative incidence rates of the 3 primary end points were 4.4%, 6.0%, and 11.3% in the sole transesophageal echocardiography guidance group and 6.4%, 8.5%, and 11.3% in the combined guidance group, respectively (P > .05). Mitral valve transcatheter edge-to-edge repair failure at 1 year was 4.8% and 6.3%, respectively (P > .05). The corresponding adjusted hazard ratios (95% CIs) for the 3 primary end points were 1.52 (0.61-3.79), 0.96 (0.42-2.18), and 0.93 (0.48-1.81), respectively. Findings were consistent in sensitivity and subgroup analyses. CONCLUSIONS:In this real-world observational cohort, mitral valve transcatheter edge-to-edge repair performed under sole transesophageal echocardiography guidance was associated with favorable procedural and follow-up outcomes, supporting the feasibility of this simplified workflow in experienced centers.
OBJECTIVE:To identify anatomic factors associated with long-term outcomes after thoracic endovascular aortic repair (TEVAR) for degenerative descending thoracic aortic aneurysm (DTAA) using a nationwide registry in Japan. METHODS:A total of 23,303 TEVAR cases from 2008 to 2015 were collected prospectively by the Japanese Committee for Stentgraft Management (JACSM). Of these, 10,293 patients who underwent initial TEVAR for degenerative DTAA were enrolled, after excluding 353 early deaths. Cox regression analysis was performed to identify factors associated with aneurysm-related death and reintervention. Adjusted restricted cubic spline (RCS) analysis was applied to examine potential nonlinear relationships between significant anatomic factors and outcomes. RESULTS:The mean patient age was 74 ± 8 years, and 7748 patients (75%) were male. Ten-year freedom from aneurysm-related death and reintervention was 75.5% and 88.4%, respectively. On multivariate analysis, aneurysm diameter, distal neck diameter, and predischarge endoleak were associated with aneurysm-related death. Aneurysm diameter, proximal and distal neck diameters, zone 2 landing, and predischarge endoleak were significant predictors of reintervention. RCS analysis for reintervention showed that increasing aneurysm diameter was associated with a higher hazard ratio (HR), reaching 2.21 (95% confidence interval [CI], 1.73-2.83) at 75 mm using 50 mm as a reference. For proximal neck diameter, the HR increased to 1.59 (95% CI, 1.30-1.96) to 35 mm compared with 30 mm. For distal neck diameter, the HR reached 1.22 (95% CI, 0.96-1.53) at 35 mm compared with 30 mm. CONCLUSIONS:The JACSM registry demonstrated that preoperative aneurysm diameter and neck diameters were associated with long-term outcomes after TEVAR for DTAA.
