Surgical versus transcatheter aortic valve replacement in low-risk Medicare beneficiaries.

OBJECTIVE: Recent approval of transcatheter aortic valve replacement (TAVR) in patients at low surgical risk has resulted in a rapid real-world expansion of TAVR in patients not otherwise examined in recent low-risk trials. We sought to evaluate the outcomes of surgical aortic valve replacement (SAVR) versus TAVR in low-risk Medicare beneficiaries. METHODS: Using the US Centers for Medicare and Medicaid Services claims database, we evaluated all beneficiaries undergoing isolated SAVR (n = 33,210) or TAVR (n = 77,885) (2018-2020). International Classification of Diseases 10th revision codes were used to define variables and frailty was defined by the validated Kim index. Doubly robust risk adjustment was performed with inverse probability weighting and multilevel regression models, as well as competing-risk time to event analysis. A low-risk cohort was identified to simulate recent low-risk trials. RESULTS: A total of 15,749 low-risk patients (8144 SAVR and 7605 TAVR) were identified. Comparison was performed with doubly robust risk adjustment accounting for all factors. TAVR was associated with lower perioperative stroke (odds ratio, 0.62; P < .001) and hospital mortality (odds ratio, 0.16; P < .001) compared with SAVR. However, risk-adjusted longitudinal analysis demonstrated TAVR was associated with higher late risk of stroke (hazard ratio, 1.65; P < .001), readmission for valve reintervention (hazard ratio, 1.88; P < .001), and all-cause mortality (hazard ratio, 1.54; P < .001) compared with SAVR. CONCLUSIONS: Among low-risk Medicare beneficiaries younger than age 75 years undergoing isolated AVR, SAVR was associated with higher index morbidity and mortality but improved 3-year risk-adjusted stroke, valve reintervention, and survival compared with TAVR.

Atrial Fibrillation Management During Surgical vs Transcatheter Aortic Valve Replacement.

BACKGROUND: Societal guidelines support atrial fibrillation (AF) treatment during surgical aortic valve replacement (SAVR). Recently, many patients with AF at low to intermediate risk are managed by transcatheter aortic valve replacement (TAVR). Therefore, we evaluated longitudinal outcomes in these populations. METHODS: The United States Centers for Medicare and Medicaid Services inpatient claims database was evaluated for all beneficiaries with AF undergoing TAVR or SAVR with/without AF treatment (2018-2020). Treatment of AF included concomitant left atrial appendage obliteration, with/without surgical ablation, or endovascular appendage occlusion and/or catheter ablation at any time. Diagnosis-related group and International Classification of Diseases, 10th Revision, codes defined procedures with doubly robust risk adjustment across each group. RESULTS: A total of 24,902 patients were evaluated (17,453 TAVR; 7,449 SAVR). Of patients undergoing SAVR, 3176 (42.6%) underwent AF treatment (SAVR+AF). Only 656 TAVR patients (4.5%) received AF treatment. Comparing well-balanced SAVR+AF vs SAVR vs TAVR, there were no differences in the in-hospital incidence of renal failure, bleeding, or stroke, but increased pacemaker requirement (odds ratio [OR], 3.45; P < .0001) and vascular injury (OR, 9.09; P < .0001) were noted in TAVR and higher hospital mortality (OR, 4.02; P < .0001) in SAVR+AF. SAVR+AF was associated with lower readmission for stroke compared with SAVR alone (hazard ratio [HR], 0.87; P = .029) and TAVR (HR, 0.68; P < .0001) and with improved survival vs TAVR (HR, 0.79; P = .019). CONCLUSIONS: In Medicare beneficiaries with AF requiring aortic valve replacement, SAVR+AF was associated with improved longitudinal survival and freedom from stroke compared with TAVR. SAVR+AF treatment should be considered first-line therapy for patients with AF requiring aortic valve replacement.

Volume Alone Does Not Predict Quality Outcomes in Hospitals Performing Pediatric Cardiac Surgery.

BACKGROUND: Lower institutional volume has been associated with inferior pediatric cardiac surgery outcomes. This study explored the variation in mortality rates among low-, mid-, and high-volume hospitals performing pediatric cardiac surgery in the United States. METHODS: The Kids' Inpatient Database was explored for the years 2016 and 2019. Hospitals performing only off-bypass coarctation and ventricular septal defect repair were omitted. The hospitals were divided into 3 groups by their annual case volume. Multivariable logistic regression models were fit to obtain risk-adjusted in-hospital mortality rates. RESULTS: A total of 25,749 operations performed by 235 hospitals were included in the study. The risk-adjusted mortality rate for the entire sample was 1.9%. There were 140 hospitals in the low-volume group, 64 hospitals in the mid-volume group, and 31 in the high-volume group. All groups had low-mortality (mortality <1.9%) and high-mortality (mortality >1.9%) hospitals. Among low-volume hospitals, 53% were low-mortality (n = 74) and 47% were high-mortality (n = 66) hospitals. Among mid-volume hospitals, 58% were low-mortality (n = 37) and 42% were high-mortality (n = 27) hospitals. Among high-volume hospitals, 68% were low-mortality (n = 21) and 32% were high-mortality (n = 10) hospitals. There was no statistically significant difference in risk-adjusted in-hospital mortality when comparing low-, mid-, and high-volume centers for 7 Society of Thoracic Surgeons benchmark procedures. CONCLUSIONS: This national, real-world, risk-adjusted volume outcome analysis highlights that volume alone may not be the sole arbiter to predict quality of pediatric cardiac surgery outcomes. Using case volume alone as a surrogate for quality may unfairly asperse high-performing, low-volume programs.

En Bloc Resection of a Giant Ganglioneuroma of the Chest Through Clamshell Thoracotomy.

Ganglioneuroma is a benign tumor requiring subtotal resection as a primary mode of treatment. There are several surgical approaches. A giant ganglioneuroma of the chest cavity may be approached via a clamshell thoracotomy. This manuscript presents a case of giant ganglioneuroma resected en bloc via clamshell thoracotomy in a seven-year-old child.

Concomitant Treatment of Atrial Fibrillation in Isolated Coronary Artery Bypass Grafting.

BACKGROUND: Societal guidelines support concomitant management of atrial fibrillation (AF) in patients undergoing cardiac surgery. To assess real-world adoption and outcomes, this study evaluated Medicare beneficiaries with AF who underwent isolated coronary artery bypass grafting (CABG) with surgical ablation (SA) or left atrial appendage obliteration (LAAO) or both procedures in combination (SA + LAAO). METHODS: The US Centers for Medicare & Medicaid Services inpatient claims database identified all patients with AF who underwent isolated CABG from 2018 to 2020. Diagnosis-related group and International Classification of Diseases-10th revision procedure codes defined covariates for doubly robust risk adjustment. RESULTS: A total of 19,524 patients with preoperative AF who underwent isolated CABG were stratified by SA + LAAO (3475 patients; 17.8%), LAAO only (4541 patients; 23.3%), or no AF treatment (11,508 patients; 58.9%). After doubly robust risk adjustment, longitudinal analysis highlighted that concomitant AF treatment with SA + LAAO (hazard ratio [HR], 0.74; P = .049) or LAAO alone (HR, 0.75; P = . 031) was associated with a significant reduction in readmission for stroke at 3 years compared with no AF treatment. Furthermore, SA + LAAO (HR, 0.86; P = .016) but not LAAO alone (HR, 0.97; P = .573) was associated with improved survival compared with no AF treatment. Finally, SA + LAAO was associated with a superior composite outcome of freedom from stroke or death at 3 years compared with LAAO alone (HR, 0.86;, P = .033) or no AF treatment (HR, 0.81; P = .001). CONCLUSIONS: In Medicare beneficiaries with AF who underwent isolated CABG, concomitant AF treatment was associated with reduced 3-year readmission for stroke. SA + LAAO was associated with superior reduction in stroke or death at 3 years compared with LAAO alone or no AF treatment.

Postoperative Outcomes in Infants Undergoing ABO-incompatible Heart Transplantation in the United States.

BACKGROUND: ABO-incompatible heart transplant is a method to increase the infant donor pool. However data on long-term survival and rejection after ABO-incompatible heart transplant in recent era are limited. METHODS: The United Network for Organ Sharing database was queried for infant heart transplants performed from January 2008 to March 2020. Patient demographics and known risk factors for posttransplant mortality were collected. Statistical analysis using Bayesian additive regression trees was performed to evaluate the association of ABO incompatibility and overall survival, graft survival, acute rejection episodes, and length of stay. RESULTS: Of 1368 included infants (age < 1 year), 280 (20.47%) were ABO incompatible. ABO incompatibility was not associated with increased all-cause mortality, acute rejection episodes, or length of stay, whereas extracorporeal membrane oxygenation and intubation status of the recipient at the time of transplantation were associated with increased all-cause mortality and graft failure. Idiopathic cardiomyopathy was associated with a decreased likelihood of posttransplant all-cause mortality. One-, 5-, and 10-year survival rates among compatible vs incompatible transplants were estimated to be 90% vs 88%, 82% vs 79%, and 77% vs 73%, respectively. CONCLUSIONS: ABO-incompatible infant heart transplant does not affect posttransplant survival, incidence of rejection, or postoperative length of stay. Therefore it remains a viable and important strategy to increase the infant donor pool.

Glass table injuries: A silent public health problem.

BACKGROUND: Glass tables can break and cause traumatic injury. This public health issue is avoidable by adequate regulatory measures. We describe the burden and characteristics of these injuries using the National Electronic Injury Surveillance System (NEISS) database and data from a level 1 trauma center. METHODS: NEISS data was extracted from 2009 to 2015. Injuries were classified by type, severity, and involvement of faulty glass using predetermined criteria. A retrospective chart review of a level 1 trauma center data was performed. Epidemiologic and outcomes data are reported. RESULTS: 3241 cases were reviewed from NEISS. 56% of injuries were attributable to faulty tables. 15% were severe. A bimodal age distribution of age under 7 and early 20s was observed. Commonly injured areas were the upper extremity and forehead. 24 trauma center cases were reviewed. 21% presented with hemodynamic instability, 34% had major organ, body cavity or joint space injuries, and 58% required surgical intervention. 30-day mortality rate was 8%. More than 54% required inpatient care. CONCLUSION: Glass table injuries are common, estimated at over 2.5 million per year. Regulation of glass quality may prevent injury. SUMMARY: Glass table injuries are more common than may be recognized and represent a public health problem that can be mitigated through proper regulatory measures.

The Effect of Continuous-Flow Left Ventricular Assist Device Duration on Postoperative Outcomes.

BACKGROUND: This study evaluated the effect of continuous-flow left ventricular assist device (CF-LVAD) duration on postoperative outcomes in heart transplant patients. METHODS: United Network of Organ Sharing heart transplant follow-up data from 2005 to 2015 were obtained. Patients supported by CF-LVADs who subsequently underwent cardiac transplantation were studied. The study population was divided into three groups by CF-LVAD duration of less than 1 year, 1 to 2 years, and more than 2 years. Multivariable Cox regression analysis was used to identify predictors of overall postoperative graft survival. Kaplan-Meier survival functions were used to estimate actuarial survival at 1, 2, and 5 years after transplant. The association between CF-LVAD duration and postoperative acute rejection episodes before and after hospital discharge was assessed. RESULTS: Of 21,336 recipients, 4,382 had CF-LVADs before cardiac transplantation: 2,603 (59.4%) had CF-LVADs for less than 1 year, 1,178 (26.9%) for 1 to 2 years, and 601 (13.7%) for more than 2 years. Donor age, high body mass index, dialysis dependence, and poor functional status at transplant were significant predictors of poor posttransplant graft survival. CF-LVAD duration was associated with increased incidence of acute rejection before hospital discharge (odds ratio, 1.14; 95% confidence interval, 1.02 to 1.28; p = 0.019). Duration was not related to acute rejection episodes after discharge. There was no difference in survival among patients with increasing time durations (hazard ratio, 1.01; 95% CI, 0.89 to 1.15; p = 0.824). Graft survival at 1, 2, and 5 years among patient groups was not significantly different (p = 0.824 by log-rank test) CONCLUSIONS: Duration of CF-LVAD support does not affect posttransplant graft survival. Longer duration of support increases acute rejection episodes; however, this may not translate into diminished survival.

Impact of Left-Ventricular Assist Device-Related Complications on Posttransplant Graft Survival.

BACKGROUND: This study describes the impact of continuous-flow left-ventricular-assist device (CF-LVAD)-related complications on postoperative outcomes. METHODS: The United Network for Organ Sharing (UNOS) heart transplant follow-up data from 2005 to 2015 were obtained. CF-LVAD patients who were bridged to transplant were studied. Device-related complications (DRCs) at patient's last follow-up before transplantation were reported in 5 categories: device thrombosis (B1), infection (B2), device malfunction (B3), life-threatening arrhythmias (B4), and others (B5). Multivariable Cox regression models were used to evaluate the association of each category of complications and number of complications with postoperative graft survival. RESULTS: Of 3,877 patients analyzed, incidence of DRCs was as following: 374 (9.65%) for thrombosis (B1), 869 (22.41%) for device-related infection (B2), 400 (10.32%) for device malfunction (B3), 135 (3.48%) for life-threatening arrhythmias (B4), and 510 (13.15%) for others (B5). A total of 2,018 (52.05%) patients did not have any DRC at last follow-up; 1,482 (38.23%) patients had 1 DRC and 377 (9.72%) patients had 2 or more DRCs. Mean time from last preoperative follow-up to transplant in patients with 0, 1, and 2 or more DRCs was 93, 18, and 11 days, respectively. Multivariate analysis showed that none of the complications (from B1 to B5) were independent risk factors for poor graft survival after cardiac transplantation. Independent predictors of postoperative graft failure were increasing donor age, inpatient status, increasing body mass index, poor functional status, ventilator dependence, and extracorporeal membrane oxygenation at the time of transplant. CONCLUSIONS: DRCs are common among advanced heart failure patients bridged to transplant with CF-LVADs. Contrary to popular belief, DRCs are not associated with poor postoperative graft survival.

Impact of Coronary Artery Disease on Postoperative Outcomes in Patients Undergoing Transcatheter Aortic Valve Replacement (TAVR): Is Preoperative Coronary Revascularization Necessary?

BACKGROUND: There remains much controversy on impact of preoperative coronary artery disease (CAD) and necessity of preoperative coronary revascularization on postoperative outcomes in patients undergoing transcatheter aortic valve replacement (TAVR). METHODS: Data were collected retrospectively for 364 consecutive patients undergoing TAVR at Newark Beth Israel Medical Center, New Jersey, from May 15, 2012 to September 17, 2015. Preoperative CAD burden was calculated by three different measures of CAD: SYNTAX score, Duke Myocardial Jeopardy score (DMJS), and number of diseased coronary arteries. A composite endpoint of allcause mortality, major adverse cardiac and cerebrovascular event, and postoperative revascularization procedures was used as the primary endpoint in the survival analysis. Association of measures of CAD to composite endpoint were evaluated by multivariate Cox regression model for the first measure and log-rank test for the last two measures, respectively. Kaplan-Meier survival curves were derived by all three CAD measures. Thirty-day and 1-year composite endpoint rates were compared among strata defined by tertiles of SYNTAX score, DMJS, and number of diseased coronary vessels. RESULTS: A subset of 238 patients who met all inclusion criteria were eligible for final analysis. There was no significant association between the composite endpoint and SYNTAX score (hazard ratio, 0.77; 95% confidence interval, 0.47-1.23; P=.27); CAD by DMJS (P=.24), or number of diseased coronary arteries (P=.60). Independent predictors of poor postoperative outcomes included male gender, STS score, and frailty. There was no statistically significant association between preoperative CAD measures and 30-day or 1-year composite endpoint rates. CONCLUSION: In patients with asymptomatic CAD undergoing TAVR for severe symptomatic aortic stenosis, preoperative coronary revascularization may not be necessary.

Outcomes following emergent open repair for thoracic aortic dissection are improved at higher volume centers in direct admissions and transfers.

BACKGROUND: The purpose of this study is (1) to define the proportion of patients undergoing emergent open repair of thoracic aortic dissection admitted directly through the emergency room versus those transferred from outside hospitals and (2) to determine if a volume-outcomes relationship exists for those patients across admission types. METHODS: De-identified patient-level data was obtained from the Nationwide Inpatient Sample (2004-2008). Patients undergoing emergent aortic surgery for thoracic aortic dissection (n = 1,507) were identified by ICD-9 codes and stratified by annual center volume into low volume (≤5 cases/year) (n = 963; 63.9 %), intermediate volume (6-10 cases/year) (n = 370; 24.5 %), and high volume (≥11 cases/year) (n = 174; 11.6 %) groups. The analysis was further stratified by admission type: direct admission (DA), transfer admission (TA), and other. The primary outcome was in-hospital mortality. Multivariate logistic regression analysis was performed comparing outcomes between high vs low and high vs intermediate volume centers. RESULTS: Overall in-hospital mortality was 21.8 % (n = 328/1,507). Absolute percent mortality at high volume centers was significantly lower (12.6 %) than at medium (20.6 %) and low volume (23.9 %) centers. For DA patients, mortality was 10.6, 21.4, and 24.0 % for high, medium, and low volume centers respectively. For TA patients, mortality was 10.2, 12.7, and 23.5 % for high, medium, and low volume centers, respectively. Multivariate analysis suggested that patients in low volume center were more likely to die compared to high volume center (Odds Ratio 2.06, 95 % CI 1.25 - 3.38, p = 0.004). Admission source was not associated with increased mortality. CONCLUSIONS: Direct admissions comprise the largest proportion of dissections regardless of volume strata, and they comprise the largest proportion in the low and intermediate volume cohorts. Admission to low volume center is an independent risk factor for increased mortality. Patients transferred to high volume centers from low volume centers have similar outcome as direct admits in terms of mortality.

Post-transplant survival in idiopathic pulmonary fibrosis patients concurrently listed for single and double lung transplantation.

BACKGROUND: Lung transplantation is a widely accepted treatment for patients with end-stage lung disease related to idiopathic pulmonary fibrosis (IPF). However, there are conflicting data on whether double lung transplant (DLT) or single lung transplant (SLT) is the superior therapy in these patients. The purpose of this study was to determine whether actuarial post-transplant graft survival among IPF patients concurrently listed for DLT and SLT is greater for recipients undergoing the former or the latter. METHODS: The United Network for Organ Sharing provided de-identified patient-level data. Analysis included lung transplant candidates with IPF listed between January 1, 2001 and December 31, 2009 (n = 3,411). The study population included 1,001 (29.3%) lung transplant recipients concurrently listed for DLT and SLT, all ≥18 years of age. The primary outcome measure was actuarial post-transplant graft survival, expressed in years. RESULTS: Among the study population, 433 (43.26%) recipients underwent SLT and 568 (56.74%) recipients underwent DLT. The analysis included 2,722.5 years at risk, with median graft survival of 5.31 years. On univariate (p = 0.317) and multivariate (p = 0.415) regression analyses, there was no difference in graft survival between DLT and SLT. CONCLUSIONS: Among IPF recipients concurrently listed for DLT and SLT, there is no statistical difference in actuarial graft survival between recipients undergoing DLT vs SLT. This analysis suggests that increased use of SLT for IPF patients may increase the availability of organs to other candidates, and thus increase the net benefit of these organs, without measurably compromising outcomes.