Utilization Trends and Volume-outcomes Relationship of Endoscopic Resection for Early Stage Esophageal Cancer.

OBJECTIVES: We describe utilization trends and center volume-outcomes relationship of ER of early stage esophageal cancer using a large hospitalbased registry. SUMMARY OF BACKGROUND DATA: ER is increasingly accepted as the preferred treatment for early stage esophageal cancer, however its utilization and the center volume-outcomes relationship in the United States is unknown. METHODS: The National Cancer Database was used to identify patients with cT1N0M0 esophageal cancer treated with ER or esophagectomy between 2004 and 2015. Relative frequencies were plotted over time. Restricted cubic splines and maximally selected rank statistics were used to identify an inflection point of center volume and survival. RESULTS: A total of 1136 patients underwent ER and 2829 patients underwent esophagectomy during the study period. Overall utilization of ER, and relative use compared to esophagectomy, increased throughout the study period. Median annualized center ER volume was 1.9 cases per year (interquartile range 0.5-5.8). Multivariable Cox regression showed increasing annualized center volume by 1 case per year was associated with improved survival. Postoperative 30- or 90-day mortality, 30-day readmission, and pathologic T upstaging rates were similar irrespective of center volume. CONCLUSIONS: Utilization of ER compared to esophagectomy for stage I esophageal cancer has increased over the past decade, though many individual centers perform fewer than 1 case annually. increasing annualized center volume by one procedure per year was associated with improved survival. increased volume beyond this was not associated with survival benefit. Referral to higher volume centers for treatment of superficial esophageal cancer should be considered.

The Impact of Adjuvant Hemithoracic Radiation on Outcomes in Patients With Stage I-III Malignant Pleural Mesothelioma: A Dual Registry Analysis.

BACKGROUND: The outcomes associated with receipt of adjuvant radiation in patients after surgery for MPM are poorly understood. OBJECTIVE: The objective of this study was to use 2 registries to compare the outcomes of patients receiving adjuvant radiation or no radiation after definitive surgery for pathologic stage I-III MPM. METHODS: Patients with resected pathologic stage I-III MPM were identified from the Duke University registry (1996-2016) and National Cancer Database (NCDB) (2004-2015). The primary outcome was overall survival. Propensity score-matched and landmark subgroup analyses were performed. RESULTS: A total of 212 institutional and 1615 NCDB patients met criteria. In both cohorts, patients who underwent radiation were more likely to have margin-negative resection and more advanced pathologic stage. At a landmark time of 4.4 and 4.7 months from surgery, Duke [hazard ratio (HR) 1.14; 95% confidence interval (CI) 0.62-2.11] and NCDB patients (HR 0.97; 95% CI 0.81-1.17) who received adjuvant radiation did not experience improved survival compared to those who did not receive radiation in multivariable analysis. Duke patients who received radiation had similar incidence of recurrence and time to both overall recurrence and ipsilateral recurrence (HR 0.87; 95% CI 0.43-1.77) compared to those who did not. Duke patients experienced 100 grade 1/2, 21 grade 3/4, and one grade 5 toxicity events during radiation. CONCLUSIONS: In this dual registry analysis of patients with resected stage I-III MPM, the receipt of adjuvant hemithoracic radiation was not associated with improved survival compared to no radiation.

The Impact of Adjuvant Therapy on Survival After Esophagectomy for Node-negative Esophageal Adenocarcinoma.

OBJECTIVE: Determine whether adjuvant chemotherapy is associated with a survival benefit in high risk T2-4a, pathologically node-negative distal esophageal adenocarcinoma. SUMMARY OF BACKGROUND DATA: There is minimal literature to substantiate the NCCN guidelines recommending adjuvant therapy for patients with distal esophageal adenocarcinoma and no pathologic evidence of nodal disease. METHODS: The National Cancer Database was used to identify adult patients with pT2-4aN0M0 esophageal adenocarcinoma who underwent definitive surgery (2004-2015) and had characteristics considered high risk by the NCCN. Patients were stratified by receipt of adjuvant chemotherapy with or without radiation. The primary outcome was overall survival, which was evaluated using Kaplan-Meier and multivariable Cox Proportional Hazards models. A 1:1 propensity score-matched analysis was also performed to compare survival between the groups. RESULTS: Four hundred three patients met study criteria: 313 (78%) without adjuvant therapy and 90 who received adjuvant chemotherapy with or without radiation (22%). In both unadjusted and multivariable analysis, adjuvant chemotherapy with or without radiation was not associated with a significant survival benefit compared to no adjuvant therapy. In a subgroup analysis of 335 patients without high risk features by NCCN criteria, adjuvant chemotherapy was not independently associated with a survival benefit. CONCLUSION: In this analysis, adjuvant chemotherapy with or without radiation was not associated with a significant survival benefit in completely resected, pathologically node-negative distal esophageal adenocarcinoma, independent of presence of high risk characteristics. The risks and benefits of adjuvant therapy should be weighed before offering it to patients with completely resected pT2-4aN0M0 esophageal adenocarcinoma.

Lung Transplantation After Ex Vivo Lung Perfusion Early Outcomes From a US National Registry.

OBJECTIVE: The objective of this study was to examine early lung transplant outcomes following EVLP using a large national transplant registry. SUMMARY OF BACKGROUND DATA: Lung transplantation in the United States continues to be constrained by a limited supply of donor organs. EVLP has the potential to significantly increase the available pool of donor lung allografts through the reconditioning of "marginal" organs. METHODS: The united network for organ sharing registry was queried for all adults (age ≥18) who underwent first-time lung transplantation between March 2018 (when united network for organ sharing began collecting confirmed donor EVLP status) and June 2019. Transplants were stratified by EVLP use. The primary outcome was short-term survival and secondary outcomes included acute rejection before discharge and need for extracorpo-real membrane oxygenation support post-transplant. RESULTS: A total of 3334 recipients met inclusion criteria including 155 (5%) and 3179 (95%) who did and did not receive allografts that had undergone EVLP, respectively. On unadjusted descriptive analysis, EVLP and non-EVLP cohorts had similar 180-day survival (92% vs 92%, P = 0.9). EVLP use was associated with a similar rate of acute rejection (13% vs 9%, P = 0.08) but increased rate of early extracorporeal membrane oxygenation use (12% vs 7%, P = 0.04). After adjustment, EVLP use was not associated with significantly increased mortality (adjusted hazard ratio 0.99, 95% confidence interval 0.62-1.58) or acute rejection (adjusted odds ratio 0.89, 95% confidence interval 0.40-1.97) compared to non-EVLP use. CONCLUSIONS: In the largest national series of EVLP lung transplant recipients, EVLP is associated with early recipient outcomes comparable to that of non-EVLP recipients with similar baseline characteristics. Longer term follow-up data is needed to further assess the impact of EVLP on post-lung transplant outcomes.

Tumor Size, Histology, and Survival After Stereotactic Ablative Radiotherapy and Sublobar Resection in Node-negative Non-small Cell Lung Cancer.

BACKGROUND: Although SABR is increasingly emerging as an alternative to surgery for node-negative non-small cell lung cancer, there is poor understanding of patients who may most benefit SABR compared to surgery. OBJECTIVE: This study examined the relationship between tumor size and the comparative outcomes of SABR and sublobar resection in patients with node-negative non-small cell lung cancer. RESULTS: A total of 59,949 patients met study criteria: 19,888 (33%) underwent SABR, 33,052 (55%) wedge resection, and 7009 (12%) segmental resection. In multivariable regression, a significant 3-way interaction was found between histology, tumor size, and type of treatment. After stratification by histology, a significant interaction between tumor size and treatment was preserved for patients with adenocarcinoma and squamous cell carcinoma. Sublobar resection was associated with greater survival compared to SABR for tumor sizes greater than 6 and 8 mm for patients with adenocarcinoma and squamous cell carcinoma, respectively. SABR was associated with similar survival compared to sublobar resection for patients with papillary and large cell histology. CONCLUSIONS: In this National Cancer Database analysis, sublobar resection was associated with greater survival compared to SABR for lesions >6or 8 mm in patients with adenocarcinoma or squamous cell carcinoma; however, SABR was associated with similar survival compared to sublobar resection in patients with aggressive tumors including papillary and large cell histology. Histologic diagnosis in patients with even small tumors may enable better treatment selection in those who cannot tolerate lobectomy.

The Relationship Between Lymph Node Ratio and Survival Benefit With Adjuvant Chemotherapy in Node-positive Esophageal Adenocarcinoma.

BACKGROUND: We hypothesized that the ratio of positive lymph nodes to total assessed lymph nodes (LNR) is an indicator of cancer burden in esophageal adenocarcinoma and may identify patients who may most benefit from AC. OBJECTIVE: The aim of this study was to discern whether there is a threshold LNR above which AC is associated with a survival benefit in this population. METHODS: The 2004-2015 National Cancer Database was queried for patients who underwent upfront, complete resection of pT1-4N1-3M0 esophageal adenocarcinoma. The primary outcome, overall survival, was examined using multivariable Cox proportional hazards models employing an interaction term between LNR and AC. RESULTS: A total of 1733 patients were included: 811 (47%) did not receive AC whereas 922 (53%) did. The median LNR was 20% (interquartile range 9-40). In a multivariable Cox model, the interaction term between LNR and receipt of AC was significant (P = 0.01). A plot of the interaction demonstrated that AC was associated with improved survival beyond a LNR of about 10%-12%. In a sensitivity analysis, the receipt of AC was not associated with improved survival in patients with LNR <12% (hazard ratio 1.02; 95% confidence interval 0.72-1.44) but was associated with improved survival in those with LNR ≥12% (hazard ratio 0.65; 95% confidence interval 0.50-0.79). CONCLUSIONS: In this study of patients with upfront, complete resection of node-positive esophageal adenocarcinoma, AC was associated with improved survival for LNR ≥12%. LNR may be used as an adjunct in multidisciplinary decision-making about adjuvant therapies in this patient population.

Cardiovascular mechanism of donor brain death and heart recipient survival.

BACKGROUND: Heart donation after donor brain death from cardiac arrest despite successful resuscitation may be associated with worse recipient outcomes due to potential graft ischemia or underlying rhythmic/structural defects. However, selected grafts from such donors often have normal cardiac function and anatomy. We investigated whether a cardiovascular mechanism of donor brain death (CV-DBD) was associated with worse recipient outcomes. METHODS: We queried the United Network for Organ Sharing (UNOS) database for first-time, single-organ, adult (age 18+) heart transplant recipients and their associated donors between January 2005 and March 2021. Recipients were stratified by donor status (CV-DBD vs. non-CV-DBD). We performed multivariable Cox proportional hazards modeling to ascertain whether receiving a CV-DBD graft was independently associated with mortality. RESULTS: Of 35,833 included recipients, 2,702 (7.5%) received CV-DBD grafts. The associated donors were significantly more likely to be female, older, and have a history of diabetes, hypertension, and substance use (all p < .001). On unadjusted Kaplan-Meier analysis, CV-DBD recipients had a significantly reduced median survival than non-CV-DBD recipients (12.0 vs. 13.1 years, log-rank p = .04). However, after adjusting for donor/recipient age, recipient comorbidities, annualized center volume, and transplantation era, CV-DBD organ status was not associated with recipient mortality (hazard ratio: 1.05, 95% confidence interval: 0.96-1.13, p = .28). CONCLUSION: In this analysis of over 35,000 heart transplants, CV-DBD status was not associated with adjusted recipient survival. Donor brain death due to cardiac arrest should not be an absolute contraindication to heart donation, although graft function should be carefully assessed before transplantation.

A three-tier system for evaluation of organ procurement organizations' willingness to pursue and utilize nonideal donor lungs.

Lungs from "nonideal," but acceptable donors are underutilized; however, organ procurement organization (OPO) metrics do not reflect the extent to which OPO-specific practices contribute to these trends. We developed a comprehensive system to evaluate nonideal lung donor avoidance, or risk aversion among OPOs. Adult donors in the UNOS registry who donated ≥1 organ for transplantation between 2007 and 2018 were included. Nonideal donors had any of age>50, smoking history ≥20 pack-years, PaO2 /FiO2 ratio ≤350, donation after circulatory death, or increased risk status. OPO-level risk aversion in donor pursuit, consent attainment, lung recovery, and transplantation was assessed. Among 83916 donors, 70372 (83.9%) were nonideal. Unadjusted OPO-level rates of nonideal donor pursuit ranged from 81 to 100%. In a three-tier system of overall risk aversion, tier 3 OPOs (least risk-averse) had the highest rates of nonideal donor pursuit, consent attainment, lung recovery, and transplantation. Tier 1 OPOs (most risk-averse) had the lowest rates of donor pursuit, consent attainment, and lung recovery, but higher rates of transplantation compared to tier 2 OPOs (moderately risk-averse). Risk aversion varies among OPOs and across the donation process. OPO evaluations should reflect early donation process stages to best differentiate over- and underperforming OPOs and encourage optimal OPO-specific performance.

Association between levosimendan, postoperative AKI, and mortality in cardiac surgery: Insights from the LEVO-CTS trial.

OBJECTIVES: We aimed to evaluate the association between levosimendan treatment and acute kidney injury (AKI) as well as assess the clinical sequelae of AKI in cardiac surgery patients with depressed left ventricular function (ejection fraction <35%). METHODS: Patients in the LEVO-CTS trial undergoing on-pump coronary artery bypass grafting (CABG), valve, or CABG/valve surgery were stratified by occurrence and severity of postoperative AKI using the AKIN classification. The association between levosimendan infusion and AKI was modeled using multivariable regression. RESULTS: Among 854 LEVO-CTS patients, 231 (27.0%) experienced postoperative AKI, including 182 (21.3%) with stage 1, 35 (4.1%) with stage 2, and 14 (1.6%) with stage 3 AKI. The rate of AKI was similar between patients receiving levosimendan or placebo. The odds of 30-day mortality significantly increased by AKI stage compared to those without AKI (stage 1: adjusted odds ratio [aOR] 2.0, 95% confidence interval [CI] 0.8-4.9; stage 2: aOR 9.1, 95% CI 3.2-25.7; stage 3: aOR 12.4, 95% CI 3.0-50.4). No association was observed between levosimendan, AKI stage, and odds of 30-day mortality (interaction P = .69). Factors independently associated with AKI included increasing age, body mass index, diabetes, and increasing baseline systolic blood pressure. Increasing baseline eGFR and aldosterone antagonist use were associated with a lower risk of AKI. CONCLUSIONS: Postoperative AKI is common among high-risk patients undergoing cardiac surgery and associated with significantly increased risk of 30-day death or dialysis. Levosimendan was not associated with the risk of AKI.

EXPANDing the Donor Pool: Quantifying the Potential Impact of a Portable Organ-Care System for Expanded Criteria Heart Donation.

The recently concluded prospective Portable Organ Care System (OCS) Heart trial to Evaluate the Safety and Effectiveness of The Portable Organ Care System Heart for Preserving and Assessing Expanded Criteria Donor Hearts for Transplantation (EXPAND) demonstrated that the use of ex vivo perfusion for expanded-criteria hearts may be a viable method for increasing the use of donor hearts. We sought to estimate the potential impact of ex vivo expanded-criteria heart perfusion on the donor pool in the United States by using a large national transplant registry. After applying the inclusion criteria of EXPAND, 8637 potentially eligible donors were identified in the U.S. between January 1, 2015, and June 30, 2019, representing a substantial potential increase in the donor pool.

Dual Procurement of Lung and Heart Allografts Does Not Negatively Affect Lung Transplant Outcomes.

BACKGROUND: The data that exists regarding multiorgan procurement outcomes is conflicted. Given the increasing demand for pulmonary allografts, it is critical to assess the impact of dual procurement on lung transplant recipient outcomes. METHODS: The United Network for Organ Sharing transplant registry was queried for all first-time adult (age ≥18) lung transplant recipients between 2006 and 2018 and stratified by concurrent heart donor status. Multiorgan transplant recipients and recipients with missing survival time were excluded. Donors were excluded if they were donating after circulatory death, did not consent or were not approached for heart donation, the heart was recovered for nontransplant purposes, or the heart was recovered for transplant but not transplanted. Post-transplant survival was analyzed using the Kaplan-Meier method and multivariable Cox proportional hazards regression. RESULTS: A total of 18,641 recipients met inclusion criteria, including 6230 (33.4%) in the nonheart donor group (NHD) and 12,409 (66.6%) in the heart donor group (HD). HD recipients demonstrated longer survival at 10 years posttransplant, with a median survival of 6.5 years as compared with 5.9 years in NHD recipients. On adjusted analysis, HD and NHD recipients demonstrated comparable survival (AHR 0.95, 95% CI 0.90-1.01). CONCLUSIONS: Concomitant heart and lung procurement was not associated with worse survival. This finding encourages maximizing the number of organs procured from each donor, particularly in the setting of urgency-driven thoracic transplantation.

Aggressive pursuit and utilization of non-ideal donor lungs does not compromise post-lung transplant survival.

BACKGROUND: Organ procurement organizations (OPOs) vary in willingness to pursue and utilize non-ideal donor lungs; implications of these practices for lung transplant (LTx) recipients remain unclear. We examined associations between OPO-level behavior toward non-ideal donors and post-LTx outcomes. METHODS: Adult lung donors and corresponding adult first-time LTx recipients in the 2008-2019 UNOS registry were included. Non-ideal donors had any of age > 50, smoking history ≥20 pack-years, PaO2 /FiO2 ratio ≤350, donation after circulatory death, or increased risk status. OPOs were classified as least, moderately, or most aggressive based on non-ideal donor pursuit, consent attainment, lung recovery, and transplantation. Post-transplant outcomes were compared among aggressiveness strata. RESULTS: Of 22,795 recipients, 6229 (27.3%), 8256 (36.2%), and 8310 (36.5%) received lungs from least, moderately, and most aggressive OPOs, respectively. Moderately aggressive OPOs had the highest recipient rates of pre-discharge acute rejection, grade 3 primary graft dysfunction, postoperative extracorporeal membrane oxygenation, and longest lengths of stay. After adjustment, moderately and most aggressive OPOs had similar risks of recipient mortality as least aggressive OPOs. CONCLUSIONS: The most and least aggressive OPOs achieve similar patient survival and short-term post-LTx outcomes. Aggressive pursuit and utilization of non-ideal donor lungs by less aggressive OPOs would likely expand the donor pool, without compromising recipient outcomes.

Center volume and primary graft dysfunction in patients undergoing lung transplantation in the United States - a cohort study.

Lung transplantation primary graft dysfunction (PGD) is common and portends poor outcomes. We examined the association of lung transplant center volume with PGD and the risk of mortality. The United Network for Organ Sharing transplant registry was queried for adult lung transplants from March 2015 to March 2019. Recipients were stratified by the occurrence of grade 3 PGD 72 h post-transplant, defined using modified ISHLT criteria. The adjusted association between volume and PGD as well as post-PGD survival was analyzed. 7322 recipients were included, among whom approximately 21% (n = 1525) experienced grade 3 PGD. After adjustment, increasing annualized lung transplant volume was associated with a decrease in the odds of PGD in a near-linear fashion (OR 0.94 per 10 transplants, 95% CI 0.89-0.99). Furthermore, increasing annualized lung transplant center volume up to approximately 55 transplants per year was associated with improved survival among patients with grade 3 PGD (HR 0.87 per 10 transplants, 95% CI 0.79-0.94). Increasing annual lung transplant center volume is associated with a decreased incidence of grade 3 PGD. Further, increasing volume among low- and medium-volume centers is associated with improved survival of patients who experience PGD.

Association of postoperative complications and outcomes following coronary artery bypass grafting.

BACKGROUND: The long-term effects of postoperative complications following coronary artery bypass grafting (CABG) are unknown. METHODS: Medicare-linked records from the Society of Thoracic Surgeons Adult Cardiac Surgery Database were queried for isolated CABG records from 2007 through 2012. Unadjusted and adjusted associations between individual postoperative complications and both mortality and all-cause rehospitalization were evaluated to 7 years using Cox proportional-hazards models and cumulative incidence functions. Because of nonproportional hazards, associations are presented as early (0 to 90 days) and late (90 days to 7 years). RESULTS: Of the 294,533 isolated CABG patients who had records linked to Medicare for long-term follow-up (median age, 73 years; 30% female), 120,721 (41%) experienced at least 1 of the complications of interest, including new-onset atrial fibrillation (30.0%), prolonged ventilation (12.3%), renal failure (4.5%), reoperation (3.5%), stroke (1.9%), and sternal wound infection (0.4%). Each of the 6 postoperative complications was associated with a significantly increased risk of mortality and rehospitalization to 7 years despite adjustment for baseline characteristics and the presence of multiple complications. Although the predominant effect of postoperative complications was observed in the first 90 days, the increased risk-adjusted hazard for death and rehospitalization continued through 7 years. CONCLUSIONS: Postoperative complications are associated with an increased risk of both early and late mortality and all-cause rehospitalization, particularly during the "value" window within 90 days of CABG. These findings underscore the need to develop avoidance strategies as well as cost-adjustment methods for each of these complications.

Outcomes following revascularization with radial artery bypass grafts: Insights from the PREVENT-IV trial.

BACKGROUND: The optimal role of radial artery grafts in coronary artery bypass grafting (CABG) remains uncertain. The purpose of this study was to examine angiographic and clinical outcomes following CABG among patients who received a radial artery graft. METHODS: Patients in the angiographic cohort of the PREVENT-IV trial were stratified based upon having received a radial artery graft or not during CABG. Baseline characteristics and 1-year angiographic and 5-year clinical outcomes were compared between patients. RESULTS: Of 1,923 patients in the angiographic cohort of PREVENT-IV, 117 received a radial artery graft. These patients had longer surgical procedures (median 253 vs 228 minutes, P < .001) and had a greater number of grafts placed (P < .0001). Radial artery grafts had a graft-level failure rate of 23.0%, which was similar to vein grafts (25.2%) and higher than left internal mammary artery grafts (8.3%). The hazard of the composite clinical outcome of death, myocardial infarction, or repeat revascularization was similar for both cohorts (adjusted hazard ratio 0.896, 95% CI 0.609-1.319, P = .58). Radial graft failure rates were higher when used to bypass moderately stenotic lesions (<75% stenosis, 37% failure) compared with severely stenotic lesions (≥75% stenosis, 15% failure). CONCLUSIONS: Radial artery grafts had early failure rates comparable to saphenous vein and higher than left internal mammary artery grafts. Use of a radial graft was not associated with a different rate of death, myocardial infarction, or postoperative revascularization. Despite the significant potential for residual confounding associated with post hoc observational analyses of clinical trial data, these findings suggest that when clinical circumstances permit, the radial artery is an acceptable alternative to saphenous vein and should be used to bypass severely stenotic target vessels.

Rationale and design of PROACT Xa: A randomized, multicenter, open-label, clinical trial to evaluate the efficacy and safety of apixaban versus warfarin in patients with a mechanical On-X Aortic Heart Valve.

Vitamin K antagonists are the only approved oral anticoagulants for long-term prophylaxis against valve thrombosis and thromboembolism in patients with a mechanical heart valve. Despite the proven efficacy and safety of anticoagulation with the oral direct factor Xa inhibitor apixaban compared with warfarin in high-risk populations including subjects with atrial fibrillation or with venous thromboembolism, it remains unknown whether patients with a mechanical heart valve can be safely managed with apixaban. The On-X Aortic Heart Valve and On-X Ascending Aortic Prosthesis with the Vascutek Gelweave Valsalva Graft may have lower rates of valve thrombosis and thromboembolism than conventional bileaflet and tilting disc valves due its unique pyrolytic carbon composition and flared inlet design. DESIGN: PROACT Xa is a randomized, multicenter, open-label, active-controlled trial comparing apixaban with warfarin in patients with an On-X Aortic Heart Valve or On-X Ascending Aortic Prosthesis with the Vascutek Gelweave Valsalva Graft. The study will randomize approximately 1,000 patients from approximately 60 sites in North America who underwent aortic valve replacement at least 3 months prior. Patients will be randomized 1:1 to receiving apixaban 5 mg twice daily or warfarin with a target international normalized ratio of 2.0-3.0. The last randomized participant will be followed for at least 2 years. The primary efficacy outcome is the composite of valve thrombosis and valve-related thromboembolism, and the primary safety outcome is major bleeding. Assuming the primary outcome occurs in warfarin-anticoagulated patients at a rate of 1.75%/patient-year, the study has more than 90% power to assess noninferiority of apixaban treatment with an absolute noninferiority margin of 1.75%/patient-year. A second co-primary analysis is to compare the hazard rate for the apixaban arm to twice the objective performance criterion for thromboembolism and valve thrombosis, that is, 3.4%/patient-year. SUMMARY: PROACT Xa will determine whether patients with an On-X Aortic Heart Valve can be anticoagulated with apixaban as an alternative to warfarin.

The Role of Adjuvant Therapy in Patients With Margin-Positive (R1) Esophagectomy: A National Analysis.

BACKGROUND: We performed a nationwide analysis to assess the impact of adjuvant therapy on survival after a microscopically margin-positive (R1) resection for esophageal cancer. METHODS: The National Cancer Database was used to identify patients with R1 resection for esophageal cancer (2004-2015). Patients were grouped by type of adjuvant therapy. Patients who had other margin status, M1 disease, neoadjuvant chemotherapy and radiation, missing survival, and no or unknown treatment were excluded. The primary outcome was overall survival. A 1:1 propensity score-matched sensitivity analysis was also performed comparing patients who received no adjuvant therapy with those who received adjuvant chemoradiation. RESULTS: Of 546 patients, 279 (51%) received adjuvant therapy and 267 (49%) did not. Patients receiving adjuvant therapy were more likely to be younger, have more advanced pathologic stage, have nonsquamous histology, and have shorter hospitalization. In multivariable analysis, adjuvant chemotherapy, radiation, and chemoradiation were all associated with improved survival compared with no adjuvant therapy. In a propensity score-matched analysis of 123 patient pairs, adjuvant chemoradiation was associated with improved survival compared with no adjuvant therapy (adjusted HR: 0.30; 95% CI: [0.22, 0.40]). CONCLUSIONS: Adjuvant therapy is associated with improved survival compared with no adjuvant therapy in patients with R1 resection for esophageal cancer even after adjustment for pathologic stage. Adjuvant therapy should be considered in patients with incompletely resected esophageal cancer in concordance with national guidelines.

Donor and recipient age matching in heart transplantation: analysis of the UNOS Registry.

The association of donor and recipient age with survival following adult heart transplantation has not been well characterized. The purpose of this study was to examine the impact of the relationship between donor and recipient age on post-transplant survival. We retrospectively reviewed the 2005-2018 UNOS heart transplant database for all adult recipients undergoing first-time isolated heart transplantation. The impact of donor and recipient age on survival was analyzed with Cox proportional hazards modeling using restricted cubic splines. A total of 25 480 heart transplant donor and recipient pairs met inclusion criteria. Unadjusted and adjusted Cox proportional hazards modeling demonstrated a near-linear association between increasing donor age and decreased survival; in addition, older and younger recipient age was associated with decreased survival. After adjustment, there was no significant interaction between donor and recipient age. Older donors decreased survival similarly in both older and younger recipients. Increasing donor age and both younger and older recipient age are independently associated with worsened post-heart transplant survival. The relationship between donor and recipient age does not significantly affect survival following heart transplant.

Early U.S. Heart Transplant Experience With Normothermic Regional Perfusion Following Donation After Circulatory Death.

BACKGROUND: Heart transplantation following donation after circulatory death (DCD HT) has short-term survival outcomes comparable to donation after brain death and has led to a significant increase in transplantation volume. The U.S. experience with the normothermic regional perfusion (NRP) DCD HT procurement method has not been evaluated. OBJECTIVES: The aim of this study was to examine short-term outcomes associated with NRP vs direct procurement and perfusion (DPP) methods used during DCD HT in the United States. METHODS: The UNOS (United Network for Organ Sharing) registry was queried for all adult (age ≥18 years) heart recipients and corresponding donors of controlled DCD HT from January 2019-December 2023. Transplantations were stratified by NRP or DPP reperfusion methods. The primary outcome was overall survival. RESULTS: A total of 918 heart donors and recipients met inclusion criteria, including 622 (68%) DPP and 296 (32%) NRP transplantations. Unadjusted Kaplan-Meier survival analysis demonstrated improved short-term survival associated with NRP (log-rank P = 0.005). After adjustment, DCD HT with NRP was independently associated with improved survival (HR: 0.39 [95% CI: 0.22-0.70]; P = 0.002). A propensity-matched analysis similarly demonstrated a cumulative survival benefit to NRP (log-rank P = 0.006). CONCLUSIONS: In this largest national series of DCD HT procurement perfusion strategies, NRP is associated with improved short-term survival as compared with DPP. This study evaluates the U.S. early experience with DCD HT, and longer-term follow-up data are needed to further assess the impact of DPP and NRP methods on post-heart transplantation outcomes.

Comparing Consumer-Directed Hospital Rankings With STS Adult Cardiac Surgery Database Outcomes.

BACKGROUND: Public interest in stratifying hospital performance has led to the proliferation of commercial, consumer-oriented hospital rankings. In cardiac surgery, little is known about how these rankings correlate with clinical registry quality ratings. METHODS: The Society of Thoracic Surgeons (STS) Adult Cardiac Surgery Database was queried for isolated coronary artery bypass grafting or coronary artery bypass grafting/valve patients at hospitals among the top 100 U.S. News & World Report (USNWR) Cardiology & Heart Surgery rankings from 2016 to 2020. Hospitals were grouped into deciles by risk-adjusted observed/expected (O/E) ratios for morbidity and mortality using the STS 2018 risk models. Agreement between STS Adult Cardiac Surgery Database and USNWR ranked deciles was calculated by Bowker symmetry test. The association between each center's annual change in STS O/E ratio and change in USNWR ranking was modeled in repeated measures regression analysis. RESULTS: Inclusion criteria were met by 524 393 patients from 149 hospitals that ranked in USNWR top 100 at least once during the study period. There was no agreement between USNWR ranking and STS major morbidity and mortality O/E ratio (P > .50 for all years). Analysis of patients undergoing surgery at the 65 hospitals that were consistently ranked in the top 100 during the study period demonstrated no association between annual change in hospital ranking and change in O/E ratio (P all > .3). CONCLUSIONS: There was no agreement between annual USNWR hospital ranking and corresponding risk-adjusted STS morbidity or mortality. Furthermore, annual changes in USNWR rankings could not be accounted for using clinical outcomes. These findings suggest that factors unrelated to key surgical outcomes may be driving consumer-directed rankings.