Ninety-Day Risk-Standardized Home Time as a Performance Metric for Cardiac Surgery Hospitals in the United States.

BACKGROUND: Assessing hospital performance for cardiac surgery necessitates consistent and valid care quality metrics. The association of hospital-level risk-standardized home time for cardiac surgeries with other performance metrics such as mortality rate, readmission rate, and annual surgical volume has not been evaluated previously. METHODS: The study included Medicare beneficiaries who underwent isolated or concomitant coronary artery bypass graft, aortic valve, or mitral valve surgery from January 1, 2013, to October 1, 2019. Hospital-level performance metrics of annual surgical volume, 90-day risk-standardized mortality rate, 90-day risk-standardized readmission rate, and 90-day risk-standardized home time were estimated starting from the day of surgery using generalized linear mixed models with a random intercept for the hospital. Correlations between the performance metrics were assessed using the Pearson correlation coefficient. Patient-level clinical outcomes were also compared across hospital quartiles by 90-day risk-standardized home time. Last, the temporal stability of performance metrics for each hospital during the study years was also assessed. RESULTS: Overall, 919 698 patients (age 74.2±5.8 years, 32% women) were included from 1179 hospitals. Median 90-day risk-standardized home time was 71.2 days (25th-75th percentile, 66.5-75.6), 90-day risk-standardized readmission rate was 26.0% (19.5%-35.7%), and 90-day risk-standardized mortality rate was 6.0% (4.0%-8.8%). Across 90-day home time quartiles, a graded decline was observed in the rates of in-hospital, 90-day, and 1-year mortality, and 90-day and 1-year readmission. Ninety-day home time had a significant positive correlation with annual surgical volume (r=0.31; P<0.001) and inverse correlation with 90-day risk-standardized readmission rate (r=-0.40; P <0.001) and 90-day risk-standardized mortality rate (r=-0.60; P <0.001). Use of 90-day home time as a performance metric resulted in a meaningful reclassification in performance ranking of 22.8% hospitals compared with annual surgical volume, 11.6% compared with 90-day risk-standardized mortality rate, and 19.9% compared with 90-day risk-standardized readmission rate. Across the 7 years of the study period, 90-day home time demonstrated the most temporal stability of the hospital performance metrics. CONCLUSIONS: Ninety-day risk-standardized home time is a feasible, comprehensive, patient-centered metric to assess hospital-level performance in cardiac surgery with greater temporal stability than mortality and readmission measures.

Reassessing the July Effect: 30 Years of Evidence Show No Difference in Outcomes.

OBJECTIVE: The aim of this study was to critically evaluate whether admission at the beginning versus end of the academic year is associated with increased risk of major adverse outcomes. SUMMARY BACKGROUND DATA: The hypothesis that the arrival of new residents and fellows is associated with increases in adverse patient outcomes has been the subject of numerous research studies since 1989. Methods: We conducted a systematic review and random-effects meta-analysis of July Effect studies published before December 20, 2019, looking for differences in mortality, major morbidity, and readmission. Given a paucity of studies reporting readmission, we further analyzed 7 years of data from the Nationwide Readmissions Database to assess for differences in 30-day readmission for US patients admitted to urban teaching versus nonteach-ing hospitals with 3 common medical (acute myocardial infarction, acute ischemic stroke, and pneumonia) and 4 surgical (elective coronary artery bypass graft surgery, elective colectomy, craniotomy, and hip fracture) conditions using risk-adjusted logistic difference-in-difference regression. RESULTS: A total of 113 studies met inclusion criteria; 92 (81.4%) reported no evidence of a July Effect. Among the remaining studies, results were mixed and commonly pointed toward system-level discrepancies in efficiency. Metaanalyses of mortality [odds ratio (95% confidence interval): 1.01 (0.98-1.05)] and major morbidity [1.01 (0.99-1.04)] demonstrated no evidence of a July Effect, no differences between specialties or countries, and no change in the effect over time. A total of 5.98 million patient encounters were assessed for readmission. No evidence of a July Effect on readmission was found for any of the 7 conditions. CONCLUSION: The preponderance of negative results over the past 30 years suggests that it might be time to reconsider the need for similarly-themed studies and instead focus on system-level factors to improve hospital efficiency and optimize patient outcomes.

Contemporary Nationwide Heart Transplantation and Left Ventricular Assist Device Outcomes in Patients with Histories of Bariatric Surgery.

Bariatric surgery may play a role in the management of morbidly obese patients with end-stage heart failure through increasing eligibility and improving the outcomes of destination therapies. We conducted a nationally representative, retrospective cohort study of patients with previous bariatric surgery undergoing either heart transplantation or left ventricular assist device implantation. Of 200 patients, < 6% experienced in-hospital mortality after destination therapy, comparable to that reported in the general population of heart recipients. Risk-adjusted outcomes differed minimally from those of obese patients undergoing destination therapy without previous bariatric surgery. This study provides important safety benchmarking data and demonstrates the feasibility of bariatric surgery as a potential bridge to left ventricular assist device implantation or heart transplantation in obese patients with end-stage heart failure.

Defining Referral Regions for Inpatient Trauma Care: The Utility of a Novel Geographic Definition.

INTRODUCTION: Geographic variation is an inherent feature of the US health system. Despite efforts to account for geographic variation in trauma system strengthening, it remains unclear how trauma "regions" should be defined. The objective of this study is to evaluate the utility of a novel definition of Trauma Referral Regions (TRR) for assessing geographic variation in inpatient trauma across the age span of hospitalized trauma patients. METHODS: Using 2016-2017 State Inpatient Databases, we assessed the extent of geographic variability in three common metrics of hospital use (localization index, market share index, net patient flow) among TRRs and, as a comparison, trauma regions alternatively defined based on Hospital Referral Regions, Hospital Service Areas, and counties. RESULTS: A total of 860,593 admissions from 102 TRRs, 127 Hospital Referral Regions, 884 Hospital Service Areas, and 583 counties were included. Consistent with expectations for distinct trauma regions, TRR presented with high average localization indices (mean [standard deviation]: 83.4 [11.7%]), low market share indices (mean [standard deviation]: 11.9 [7.0%]), and net patient flows close to 1.00. Similar results were found among stratified pediatric, adult, and older adult patients. Associations between TRRs and variations in important demographic features (e.g., travel time by road to the nearest Level I or II Trauma Center) suggest that while indicative of standalone trauma regions, TRRs are also able to simultaneously capture critical variations in regional trauma care. CONCLUSIONS: TRRs offer a standalone set of geographic regions with minimal variation in common metrics of hospital use, minimal geographic clustering, and preserved associations with important demographic factors. They provide a needed, valid means of assessing geographic variation among trauma systems.

Aortic root management in acute type A aortic dissection: A nationwide analysis.

OBJECTIVE: Acute type A aortic dissection (ATAAD) is a life-threatening condition and surgical repair often includes aortic valve replacement (AVR). Aortic valve repair (AVr) is increasingly being reported with favorable outcomes from single-center experiences. This study examined national trends and outcomes of AVr in patients with ATAAD. METHODS: Adults with a primary diagnosis of acute thoracic aortic dissection who underwent proximal aortic surgery from January 2016 to December 2017 were obtained from the National Inpatient Sample. Patients were stratified into an isolated aortic surgery group (no aortic valve procedure), concomitant AVR, or concomitant AVr groups. The primary outcome was in-hospital mortality and secondary outcomes included stroke, acute kidney injury, heart block, and bleeding. Propensity score matching was used to address patient and hospital-level confounders between AVR and AVr groups. RESULTS: In total, 5115 patients underwent surgery for ATAAD and were included. Overall, 3220 (63%) underwent isolated ATAAD repair, while 1120 (22%) had concomitant AVR, and 775 (15%) had concomitant AVr. In 455 propensity-matched pairs, there was no difference in mortality or stroke between AVr and AVR groups, however, heart block (1.1% vs. 7.5%, p < .001) and bleeding (65.9% vs. 81.3%, p < .001) were significantly less common among those who underwent AVr. Patients who underwent AVr had shortest LOS (11.9 vs. 13.5 days, p < .001). There were no differences in outcomes of AVr in ATAAD based on hospital size or teaching status. CONCLUSION: In selected patients, AVr is being performed safely in the setting of ATAAD with mortality and composite outcomes comparable to AVR.

Balloon versus self-expandable transcatheter aortic valve implantation for bicuspid aortic valve stenosis: A meta-analysis of observational studies.

BACKGROUND: There is a rising trend for transcatheter aortic valve implantation (TAVI) in bicuspid aortic stenosis patients. Data on the use of self-expandable (SEV) vs. balloon-expandable (BEV) valves in these patients are scarce. Therefore, we systematically compared clinical outcomes in bicuspid aortic stenosis patients treated with SEV and BEV. METHODS: Data were extracted from PubMed/MEDLINE, EMBASE, CENTRAL/CCTR, ClinicalTrials.gov, SciELO, LILACS, Google Scholar and reference lists of relevant articles. Eight studies published from 2013 to 2020 including a total of 1,080 patients (BEV: n = 620; SEV: n = 460) were selected. Primary endpoints were procedural, 30-day and 1-year mortality. Secondary endpoints were new pacemaker implantation, annular rupture, coronary obstruction, moderate-to-severe paravalvular leak, need of second valve, stroke and acute kidney injury. RESULTS: We found no statistically significant difference in mortality between patients treated with BEV vs. SEV during index procedure, at 30 days and at 1 year. BEVs showed a statistically significant higher risk of annulus rupture (2.5%) in comparison with SEV (0%) (OR 5.81 [95% CI, 3.78-8.92], p < .001). New generation BEVs were also associated with significantly less paravalvular leak when compared to new generation SEVs (OR 0.08 [95% CI, 0.02-0.35], p = .001). CONCLUSIONS: This meta-analysis of observational studies of TAVI for bicuspid valves, showed no difference in short- and mid-term TAVI mortality with BEVs and SEVs. BEVs presented a higher risk of annular rupture in comparison with SEV.

Acute kidney injury in renal transplant recipients undergoing cardiac surgery.

BACKGROUND: Acute kidney injury (AKI) is a key risk factor for chronic kidney disease in the general population, but has not been investigated in detail among renal transplant recipients (RTRs). We investigated the incidence, severity and risk factors for AKI following cardiac surgery among RTRs compared with non-RTRs with otherwise similar clinical characteristics. METHODS: We conducted a retrospective cohort study of RTRs (n = 83) and non-RTRs (n = 83) who underwent cardiac surgery at two major academic medical centers. Non-RTRs were matched 1:1 to RTRs by age, preoperative (preop) estimated glomerular filtration rate and type of cardiac surgery. We defined AKI according to Kidney Disease: Improving Global Outcomes criteria. RESULTS: RTRs had a higher rate of AKI following cardiac surgery compared with non-RTRs [46% versus 28%; adjusted odds ratio 2.77 (95% confidence interval 1.36-5.64)]. Among RTRs, deceased donor (DD) versus living donor (LD) status, as well as higher versus lower preop calcineurin inhibitor (CNI) trough levels, were associated with higher rates of AKI (57% versus 33% among DD-RTRs versus LD-RTRs; P = 0.047; 73% versus 36% among RTRs with higher versus lower CNI trough levels, P = 0.02). The combination of both risk factors (DD status and higher CNI trough level) had an additive effect (88% AKI incidence among patients with both risk factors versus 25% incidence among RTRs with neither risk factor, P = 0.004). CONCLUSIONS: RTRs have a higher risk of AKI following cardiac surgery compared with non-RTRs with otherwise similar characteristics. Among RTRs, DD-RTRs and those with higher preop CNI trough levels are at the highest risk.

Expert Consensus of Data Elements for Collection for Enhanced Recovery After Cardiac Surgery.

BACKGROUND: Despite the emergence of Enhanced Recovery Protocols (ERPs) in cardiac surgery, there is no consensus on the essential elements for data reporting for quality improvement efforts, as well as accountability and standardization of outcome reporting across institutions. The aim of this study was to establish a consensus on essential data elements for cardiac ERAS®. METHODS: A 2-round modified Delphi technique was utilized based on existing recommendations from the recently published ERAS® cardiac surgery consensus guidelines. Round 1 included a steering committee of 10 experts who oversaw formulation of a focused list of data elements into 3 main areas: Preoperative, intraoperative and postoperative. Round 2 consisted of a multidisciplinary, multinational, heterogenous group of 50 voting experts from across the United States and Europe. All participants evaluated their level of agreement with each data element using a 5-point Likert scale with consensus threshold of 70%. RESULTS: In round 1, 17 data elements were considered essential (consensus > = 70%, either positive or negative) and 6 were considered marginal (consensus < = 70%, either positive or negative). In round 2, positive consensus was achieved for 15/17 (88.2%) data elements in the essential category, and all six data elements (100%) in the marginal category, indicating a high level of overall agreement. CONCLUSION: This initial study, which identified 21 key data elements for collection in an ERAS® cardiac program, will aid clinicians in establishing a framework for evaluating the quality of their contemporary ERP processes and will allow acquisition of data to help benchmark performance metrics between hospitals.

Comparison of in-hospital outcomes and readmissions for valve-in-valve transcatheter aortic valve replacement vs. reoperative surgical aortic valve replacement: a contemporary assessment of real-world outcomes.

AIMS: We sought to perform a head-to-head comparison of contemporary 30-day outcomes and readmissions between valve-in-valve transcatheter aortic valve replacement (VIV-TAVR) patients and a matched cohort of high-risk reoperative surgical aortic valve replacement (re-SAVR) patients using a large, multicentre, national database. METHODS AND RESULTS: We utilized the nationally weighted 2012-16 National Readmission Database claims to identify all US adult patients with degenerated bioprosthetic aortic valves who underwent either VIV-TAVR (n = 3443) or isolated re-SAVR (n = 3372). Thirty-day outcomes were compared using multivariate analysis and propensity score matching (1:1). Unadjusted, VIV-TAVR patients had significantly lower 30-day mortality (2.7% vs. 5.0%), 30-day morbidity (66.4% vs. 79%), and rates of major bleeding (35.8% vs. 50%). On multivariable analysis, re-SAVR was a significant risk factor for both 30-day mortality [adjusted odds ratio (aOR) of VIV-SAVR (vs. re-SAVR) 0.48, 95% confidence interval (CI) 0.28-0.81] and 30-day morbidity [aOR for VIV-TAVR (vs. re-SAVR) 0.54, 95% CI 0.43-0.68]. After matching (n = 2181 matched pairs), VIV-TAVR was associated with lower odds of 30-day mortality (OR 0.41, 95% CI 0.23-0.74), 30-day morbidity (OR 0.53, 95% CI 0.43-0.72), and major bleeding (OR 0.66, 95% CI 0.51-0.85). Valve-in-valve TAVR was also associated with shorter length of stay (median savings of 2 days, 95% CI 1.3-2.7) and higher odds of routine home discharges (OR 2.11, 95% CI 1.61-2.78) compared to re-SAVR. CONCLUSION: In this large, nationwide study of matched high-risk patients with degenerated bioprosthetic aortic valves, VIV-TAVR appears to confer an advantage over re-SAVR in terms of 30-day mortality, morbidity, and bleeding complications. Further studies are warranted to benchmark in low- and intermediate-risk patients and to adequately assess longer-term efficacy.

Coronavirus disease 19 in minority populations of Newark, New Jersey.

BACKGROUND: The purpose of this study is to report the clinical features and outcomes of Black/African American (AA) and Latino Hispanic patients with Coronavirus disease 2019 (COVID-19) hospitalized in an inter-city hospital in the state of New Jersey. METHODS: This is a retrospective cohort study of AA and Latino Hispanic patients with COVID-19 admitted to a 665-bed quaternary care, teaching hospital located in Newark, New Jersey. The study included patients who had completed hospitalization between March 10, 2020, and April 10, 2020. We reviewed demographics, socioeconomic variables and incidence of in-hospital mortality and morbidity. Logistic regression was used to identify predictor of in-hospital death. RESULTS: Out of 416 patients, 251 (60%) had completed hospitalization as of April 10, 2020. The incidence of In-hospital mortality was 38.6% (n = 97). Most common symptoms at initial presentation were dyspnea 39% (n = 162) followed by cough 38%(n = 156) and fever 34% (n = 143). Patients were in the highest quartile for population's density, number of housing units and disproportionately fell into the lowest median income quartile for the state of New Jersey. The incidence of septic shock, acute kidney injury (AKI) requiring hemodialysis and admission to an intensive care unit (ICU) was 24% (n = 59), 21% (n = 52), 33% (n = 82) respectively. Independent predictors of in-hospital mortality were older age, lower serum Hemoglobin < 10 mg/dl, elevated serum Ferritin and Creatinine phosphokinase levels > 1200 U/L and > 1000 U/L. CONCLUSIONS: Findings from an inter-city hospital's experience with COVID-19 among underserved minority populations showed that, more than one of every three patients were at risk for in-hospital death or morbidity. Older age and elevated inflammatory markers at presentation were associated with in-hospital death.

Transcatheter vs surgical aortic valve replacement in patients with interstitial lung disease.

BACKGROUND: Patients with underlying interstitial lung disease (ILD) who undergo cardiac surgery are at high risk of postoperative pulmonary complications. It remains unclear if transcatheter aortic valve replacement (TAVR) offers any benefit over surgical aortic valve replacement (SAVR) in ILD patients with severe aortic stenosis. METHODS: All adult patients with a diagnosis of ILD who underwent either a TAVR or isolated SAVR between January 2002 and December 2017 were retrospectively reviewed. Operative mortality, 30-day readmissions, and adjusted 1-year survival were compared between the two cohorts. RESULTS: The overall cohort included 52 TAVR and 74 SAVR patients. While TAVR patients were significantly older (77.2 vs 72.9 years) with higher Society of Thoracic Surgeons predicted risk of mortality (STS-PROM) scores compared with SAVR patients (6.29 vs 4.49; all P < .02), operative mortality was similar (5.8% vs 4.1%; P = .45). Rates of postoperative stroke, permanent pacemaker implantation, reintubation, and 30-day readmissions did not differ between the two groups (all P > .46). However, TAVR was associated with significantly shorter hospital and intensive care unit (ICU) length of stay, shorter ventilation times, and less requirement for ICU admission (all P < .05). Thirty-day readmissions and adjusted 1-year survival were also similar between the two groups (hazard ratio for TAVR vs SAVR = 1.34; 95% CI: 0.7-2.6). CONCLUSIONS: Among ILD patients with symptomatic aortic stenosis, TAVR was associated with comparable operative and risk-adjusted 1-year survival to SAVR. TAVR patients also had shorter ventilator times, ICU and hospital stay despite being at higher risk. Together, our findings suggest that TAVR may be a better option in this unique cohort.

Chronic opioid use after coronary bypass surgery.

BACKGROUND: Opioid dependence has become a major health care issue. Pain management of invasive surgical procedures with opioids may potentially contribute to this epidemic. We sought to determine the association of opioid-prescribing patterns with chronic opioid use. METHODS: We retrospectively reviewed all patients undergoing isolated coronary artery bypass graft (CABG) procedures during 2016 at a single institution. Prescribing patterns and medication usage were compared between opioid-naïve and opioid-exposed patients (patients with reported opioid use within 30 days prior to surgery). Chronic opioid dependence was defined as opioid usage beyond 90 days after discharge. RESULTS: We included 284 opioid-naïve and 46 opioid-exposed patients. Although overall prescribing patterns were similar between groups, a higher proportion of opioid-exposed patients were prescribed a total dose >150 mg of oxycodone per discharge prescription (15.2% vs 4.9%; P = 0.024), and had a higher proportion of refills within 30 days (28.3% vs 10.9%; relative risk [RR] 3.2 [95% confidence interval (CI): 1.5-6.8]; all P < 0.05). The incidence of chronic opioid dependence was higher among opioid-exposed patients compared to opioid-naïve patients (21.7% vs 3.2%; RR 8.5 [95%CI: 3.2-22.3]; P = 0.001). CONCLUSIONS: Ongoing opioid use 3 months after CABG is present in 21.7% of opioid-exposed patients and 3.2% of opioid-naïve patients. These preliminary findings highlight the burden of prescribing patterns on the overall opioid epidemic and the need to develop alternative pain management strategies.

The Impact of Hospital Size on National Trends and Outcomes Following Open Esophagectomy.

Background and Objectives: Previous studies have demonstrated superior patient outcomes for thoracic oncology patients treated at high-volume surgery centers compared to low-volume centers. However, the specific role of overall hospital size in open esophagectomy morbidity and mortality remains unclear. Materials and Methods: Patients aged >18 years who underwent open esophagectomy for primary malignant neoplasia of the esophagus between 2002 and 2014 were identified using the National Inpatient Sample. Minimally invasive procedures were excluded. Discharges were stratified by hospital size (large, medium, and small) and analyzed using trend and multivariable regression analyses. Results: Over a 13-year period, a total of 69,840 open esophagectomy procedures were performed nationally. While the proportion of total esophagectomies performed did not vary by hospital size, in-hospital mortality trends decreased for all hospitals (large (7.2% to 3.7%), medium (12.8% vs. 4.9%), and small (12.8% vs. 4.9%)), although this was only significant for large hospitals (P < 0.01). After controlling for patient demographics, comorbidities, admission, and hospital-level factors, hospital length of stay (LOS), total inflation-adjusted costs, in-hospital mortality, and complications (cardiac, respiratory, vascular, and bleeding) did not vary by hospital size (all P > 0.05). Conclusions: After risk adjustment, patient morbidity and in-hospital mortality appear to be comparable across all institutions, including small hospitals. While there appears to be an increased push for referring patients to large hospitals, our findings suggest that there may be other factors (such as surgeon type, hospital volume, or board status) that are more likely to impact the results; these need to be further explored in the current era of episode-based care.

Clinical Significance of Greater Implantation Height with SAPIEN 3 Transcatheter Heart Valve.

BACKGROUND: A lower rate of permanent pacemaker (PPM) has been linked to a target aortic implantation height (AIH) >0.70, following transcatheter aortic valve replacement (TAVR) with the SAPIEN 3 valve. Based on clinical experience, it was hypothesized that a higher AIH (≥0.85) would lower the rate of PPM implantation. METHODS: A total of 127 patients (66 females, 61 males; mean age 82 ± 8 years) underwent TAVR with the SAPIEN 3 valve between May 2015 and July 2016. AIH was defined as the proportion of the valve frame above the aortic annulus in the post-deployment aortogram. A target AIH (≥0.70) was achieved in 113 patients (89%). Cases were stratified into a High Implantation (HI) group (AIH ≥0.85; 33 patients) or a Standard Implantation (SI) group (AIH <0.85; 94 patients). RESULTS: The mean Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) score of all patients was 6.4 ± 3.5%. Preoperative right bundle branch block (RBBB) was prevalent in 13% of SI patients, and in 18% of HI patients (p = 0.56). There were no significant differences in operative mortality (3.2% versus 0%), median length of stay (2 days versus 3 days) and incidence of moderate-to-severe paravalvular leak (3.2% versus 0%; all p >0.410) between SI and HI patients, respectively. Likewise, the incidence of new PPM did not differ between the two groups (12% in HI versus 13% in SI; p ≥0.99). The mean AIH was similar for patients with PPM implantation (0.80 ± 0.08) compared to those without (0.78 ± 0.06; p = 0.520). Preoperative RBBB was significantly associated with PPM implantation (odds ratio (OR) 10.1; p = 0.002), and patients who underwent PPM implantation had a higher operative mortality (12.5% versus 1%; p = 0.040). CONCLUSIONS: Among TAVR patients who received the SAPIEN 3 heart valve, a higher AIH (≥0.85) was not associated with a lower rate of PPM implantation or increased operative mortality. Prior RBBB was the only independent risk factor for new PPM implantation. Long-term follow up is crucial in determining the clinical significance of PPM implantation.

Power-Assisted Particulate Bone Grafting Effectively Prevents Osseous Defects After Cranial Vault Reconstruction.

BACKGROUND: Cranial vault reconstruction (CVR) is the gold standard in the operative treatment of craniosynostosis. Full thickness osseous defects (FTOD) of the calvaria have been observed in 5% to 15% patients after CVR, with higher rates cited in the fronto-orbital advancement (FOA) subset. Particulate bone graft (PBG) harvested manually has been shown to decrease FTOD after FOA from 24% to 5.5%. The authors used a modified technique using a powered craniotome, with the hypothesis that the technique would also improve outcomes. METHODS: A retrospective review was performed of patients who underwent CVR for craniosynostosis between 2004 and 2014. Patient demographics, diagnosis, age, operative details, and postoperative care were reviewed in detail. Categorical, nonparametric variables were compared by Fisher exact tests. RESULTS: A total of 135 patients met inclusion criteria. The most common diagnoses were metopic (n = 41), sagittal (n = 33), and unilateral coronal craniosynostosis (n = 31); 65% (n = 88) underwent FOA, 29% (n = 39) underwent single-stage total vault reconstruction, and 6% (n = 8) had a posterior vault reconstruction. CVR was performed without PBG in 95 patients and with PBG in 40 patients. Without PBG, FTOD were discovered on clinical examination in 18% of patients (n=17): 11 presented with subcentimeter defects, while 6 had larger defects requiring revision cranioplasty (6% operative revision rate). Among those receiving PBG, 1 patient presented a subcentimeter FTOD (2.5% FTOD incidence and 0% operative revision rate). CONCLUSION: Particulate bone graft harvested with a powered device decreases the rate of FTOD and reoperation rate after CVR for craniosynostosis.

Predicting risk of cardiac events among ST-segment elevation myocardial infarction patients with conservatively managed non-infarct-related artery coronary artery disease: An analysis of the Duke Databank for Cardiovascular Disease.

BACKGROUND: Recent randomized evidence has demonstrated benefit with complete revascularization during the index hospitalization for multivessel coronary artery disease ST-segment elevation myocardial infarction (STEMI) patients; however, this benefit likely depends on the risk of future major adverse cardiovascular events (MACE). METHODS: Using data from Duke University Medical Center (2003-2012), we identified those at high risk for 1-year MACE among 664 STEMI patients with conservatively managed non-infarct-related artery (non-IRA) lesions. Using multivariable logistic regression, we identified clinical and angiographic characteristics associated with MACE (death, myocardial infarction, urgent revascularization) to 1 year and developed an integer-based risk prediction model for clinical use. RESULTS: In this cohort (median age 60 years, 30% female), the unadjusted Kaplan-Meier rates for MACE at 30 days and 1 year were 10% and 28%, respectively. Characteristics associated with MACE at 1 year included reduced left ventricular ejection fraction, hypertension, heart failure, higher-risk non-IRA vessels (left main), renal insufficiency, and greater % stenosis of non-IRA lesions. A 15-point risk score including these variables had modest discrimination (C-index 0.67) across a spectrum of subsequent risk (4%-88%) for 1-year MACE. CONCLUSIONS: There is a wide spectrum of risk following primary percutaneous coronary intervention for STEMI patients with multivessel disease. Using readily available clinical characteristics, the expected incidence of MACE by 1 year can be calculated with a simplified risk score, facilitating a tailored approach to clinical care.

The association of donor age and survival is independent of ischemic time following deceased donor lung transplantation.

PURPOSE: Early research suggests prolonged ischemic time in older donor lungs is associated with decreased survival following lung transplantation. The purpose of this study was to determine whether this association holds in the post-lung allocation score era. METHODS: We analyzed the United Network for Organ Sharing database 2005-2013 for adult recipients of cadaveric lung transplants. Cox proportional hazards modeling was utilized to determine the association of donor age, ischemic time, and the interaction of donor age and ischemic time with transplant-free survival. RESULTS: Eleven thousand eight hundred thirty-five patients met criteria. Median donor age was 32 years, and median ischemic time was 4.9 hours. Cox modeling demonstrated that donor age 50-60 (adjusted hazard ratio (HR): 1.11) and ≥60 (adjusted HR: 1.42) were associated with reduced overall survival. Neither ischemic time nor interaction of ischemic time and donor age were significantly associated with overall survival. Subanalysis demonstrated that this finding held true for patients undergoing either single or bilateral lung transplantation. CONCLUSIONS: Prolonged ischemic time is not associated with decreased overall survival in patients undergoing lung transplantation regardless of the donor's age. However, donor age >50 is independently associated with decreased survival. The lack of an association between ischemic time and survival should encourage broader geographic allocation of pulmonary allografts.

Lung transplantation delays gastric motility in patients without prior gastrointestinal surgery-A single-center experience of 412 consecutive patients.

PURPOSE: To examine the impact of lung transplantation on gastric motility. METHODS: Adult recipients at a large, single center, who were retrospectively evaluated with solid gastric emptying (SGE) study post-lung transplantation, but had no history of gastrointestinal intervention (ie, pyloroplasty or fundoplication), were selected between June 2005 and August 2013. Multivariable logistic regression was performed to determine risk factors associated with delayed gastric emptying (DGE) after transplantation. RESULTS: Delayed gastric emptying (DGE) was noted in 236 patients (57%) after transplantation. On multivariable logistic regression, an underlining diagnosis of cystic fibrosis (CF)/bronchiectasis (adjusted odds ratio [AOR] 3.26, P < .01) was a significant risk factor in predicting DGE after lung transplantation. There was no survival difference between patients with postoperative DGE vs those without (log-rank test P = .53). CONCLUSIONS: Delayed gastric emptying is very common following lung transplantation, occurring in over half of all lung transplant recipients with increased prevalence in patients with CF. The association with cystic fibrosis could be secondary to extra-pulmonary manifestations of the underlying disease or indicative of increased intraoperative vagal nerve injury. We speculate that DGE may play a substantial role in the increased reflux-induced allograft injury seen after lung transplantation. Further prospective studies are needed to validate this hypothesis.

Long-term survival following kidney transplantation in previous lung transplant recipients-An analysis of the unos registry.

BACKGROUND: Kidney transplantation has been advocated as a therapeutic option in lung recipients who develop end-stage renal disease (ESRD). This analysis outlines patterns of allograft survival following kidney transplantation in previous lung recipients (KAL). METHODS: Data from the UNOS lung and kidney transplantation registries (1987-2013) were cross-linked to identify lung recipients who were subsequently listed for and/or underwent kidney transplantation. Time-dependent Cox models compared the survival rates in KAL patients with those waitlisted for renal transplantation who never received kidneys. Survival analyses compared outcomes between KAL patients and risk-matched recipients of primary, kidney-only transplantation with no history of lung transplantation (KTx). RESULTS: A total of 270 lung recipients subsequently underwent kidney transplantation (KAL). Regression models demonstrated a lower risk of post-listing mortality for KAL patients compared with 346 lung recipients on the kidney waitlist who never received kidneys (P<.05). Comparisons between matched KAL and KTx patients demonstrated significantly increased risk of death and graft loss (P<.05), but not death-censored graft loss, for KAL patients (P = .86). CONCLUSIONS: KAL patients enjoy a significant survival benefit compared with waitlisted lung recipients who do not receive kidneys. However, KAL patients do poorly compared with KTx patients. Decisions about KAL transplantation must be made on a case-by-case basis considering patient and donor factors.

Complete versus culprit-only revascularisation in ST elevation myocardial infarction with multi-vessel disease.

BACKGROUND: Multi-vessel coronary disease in people with ST elevation myocardial infarction (STEMI) is common and is associated with worse prognosis after STEMI. Based on limited evidence, international guidelines recommend intervention on only the culprit vessel during STEMI. This, in turn, leaves other significantly stenosed coronary arteries for medical therapy or revascularisation based on inducible ischaemia on provocative testing. Newer data suggest that intervention on both the culprit and non-culprit stenotic coronary arteries (complete intervention) may yield better results compared with culprit-only intervention. OBJECTIVES: To assess the effects of early complete revascularisation compared with culprit vessel only intervention strategy in people with STEMI and multi-vessel coronary disease. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials, MEDLINE, Embase, World Health Organization International Clinical Trials Registry Platform Search Portal, and ClinicalTrials.gov. The date of the last search was 4 January 2017. We applied no language restrictions. We handsearched conference proceedings to December 2016, and contacted authors and companies related to the field. SELECTION CRITERIA: We included only randomised controlled trials (RCTs), wherein complete revascularisation strategy was compared with a culprit-only percutaneous coronary intervention (PCI) for the treatment of people with STEMI and multi-vessel coronary disease. DATA COLLECTION AND ANALYSIS: We assessed the methodological quality of each trial using the Cochrane 'Risk of bias' tool. We resolved the disagreements by discussion among review authors. We followed standard methodological approaches recommended by Cochrane. The primary outcomes were long-term (one year or greater after the index intervention) all-cause mortality, long-term cardiovascular mortality, long-term non-fatal myocardial infarction, and adverse events. The secondary outcomes were short-term (within the first 30 days after the index intervention) all-cause mortality, short-term cardiovascular mortality, short-term non-fatal myocardial infarction, revascularisation, health-related quality of life, and cost. We analysed data using fixed-effect models, and expressed results as risk ratios (RR) with 95% confidence intervals (CI). We used GRADE criteria to assess the quality of evidence and we conducted Trial Sequential Analysis (TSA) to control risks of random errors. MAIN RESULTS: We included nine RCTs, that involved 2633 people with STEMI and multi-vessel coronary disease randomly assigned to either a complete (n = 1381) versus culprit-only (n = 1252) revascularisation strategy. The complete and the culprit-only revascularisation strategies did not differ for long-term all-cause mortality (65/1274 (5.1%) in complete group versus 72/1143 (6.3%) in culprit-only group; RR 0.80, 95% CI 0.58 to 1.11; participants = 2417; studies = 8; I2 = 0%; very low quality evidence). Compared with culprit-only intervention, the complete revascularisation strategy was associated with a lower proportion of long-term cardiovascular mortality (28/1143 (2.4%) in complete group versus 51/1086 (4.7%) in culprit-only group; RR 0.50, 95% CI 0.32 to 0.79; participants = 2229; studies = 6; I2 = 0%; very low quality evidence) and long-term non-fatal myocardial infarction (47/1095 (4.3%) in complete group versus 70/1004 (7.0%) in culprit-only group; RR 0.62, 95% CI 0.44 to 0.89; participants = 2099; studies = 6; I2 = 0%; very low quality evidence). The complete and the culprit-only revascularisation strategies did not differ in combined adverse events (51/2096 (2.4%) in complete group versus 57/1990 (2.9%) in culprit-only group; RR 0.84, 95% CI 0.58 to 1.21; participants = 4086; I2 = 0%; very low quality evidence). Complete revascularisation was associated with lower proportion of long-term revascularisation (145/1374 (10.6%) in complete group versus 258/1242 (20.8%) in culprit-only group; RR 0.47, 95% CI 0.39 to 0.57; participants = 2616; studies = 9; I2 = 31%; very low quality evidence). TSA of long-term all-cause mortality, long-term cardiovascular mortality, and long-term non-fatal myocardial infarction showed that more RCTs are needed to reach more conclusive results on these outcomes. Regarding long-term repeat revascularisation more RCTs may not change our present result. The quality of the evidence was judged to be very low for all primary and the majority of the secondary outcomes mainly due to risk of bias, imprecision, and indirectness. AUTHORS' CONCLUSIONS: Compared with culprit-only intervention, the complete revascularisation strategy may be superior due to lower proportions of long-term cardiovascular mortality, long-term revascularisation, and long-term non-fatal myocardial infarction, but these findings are based on evidence of very low quality. TSA also supports the need for more RCTs in order to draw stronger conclusions regarding the effects of complete revascularisation on long-term all-cause mortality, long-term cardiovascular mortality, and long-term non-fatal myocardial infarction.