Racial disparities among patients on venovenous extracorporeal membrane oxygenation in the pre-Coronavirus Disease 2019 and Coronavirus Disease 2019 eras: A retrospective registry review.

Objectives: Although many studies have addressed such disparities caused by COVID-19, to our knowledge, no study has focused on the association of race on outcomes for patients with COVID-19 requiring venovenous extracorporeal membrane oxygenation support. The goal of this study was to assess association of race on death and duration on venovenous extracorporeal membrane oxygenation in both the pre-COVID-19 and COVID-19 eras. Methods: We retrospectively reviewed the Extracorporeal Life Support Organization registry and included adults (≥18 years) who required venovenous extracorporeal membrane oxygenation between January 2019 and April 2021. We performed descriptive statistics and multivariable logistic regression. Our primary outcomes were death and extracorporeal membrane oxygenation duration. Results: A total of 7477 patients were included after excluding 340 patients (4.3%) who were missing race data. In the COVID-19 era, 1474 of 2777 COVID-19-positive patients (53.1%) died. Our regression model suggested somewhat of a protective effect on death for Black and multiple race patients. Additionally, a diagnosis of COVID-19 and patients in the COVID-19 era in general, irrespective of COVID-19 diagnosis, had higher odds of death. Hispanic patients had the longest average venovenous extracorporeal membrane oxygenation run times. Conclusions: Our study using data from the international Extracorporeal Life Support Organization Registry provides updated data on patients supported with venovenous extracorporeal membrane oxygenation in the pre-COVID-19 and COVID-19 eras between 2019 and 2021 with a focus on race. Patients in the COVID-19 era group also had higher mortality compared with those in the pre-COVID-19 era even after being adjusted for COVID-19 diagnosis. Black and multiple races appeared somewhat protective in terms of death. Hispanic race was associated with longer venovenous extracorporeal membrane oxygenation duration.

Outcomes after heart transplantation in patients who have undergone a bridge-to-bridge strategy.

Objectives: We compared posttransplant outcomes between patients bridged from temporary mechanical circulatory support to durable left ventricular assist device before transplant (bridge-to-bridge [BTB] strategy) and patients bridged from temporary mechanical circulatory support directly to transplant (bridge-to-transplant [BTT] strategy). Methods: We identified adult heart transplant recipients in the Organ Procurement and Transplantation Network database between 2005 and 2020 who were supported with extracorporeal membrane oxygenation, intra-aortic balloon pump, or temporary ventricular assist device as a BTB or BTT strategy. Kaplan-Meier survival analysis and Cox regressions were used to assess 1-year, 5-year, and 10-year survival. Posttransplant length of stay and complications were compared as secondary outcomes. Results: In total, 201 extracorporeal membrane oxygenation (61 BTB, 140 BTT), 1385 intra-aortic balloon pump (460 BTB, 925 BTT), and 234 temporary ventricular assist device (75 BTB, 159 BTT) patients were identified. For patients supported with extracorporeal membrane oxygenation, intra-aortic balloon pump, or temporary ventricular assist device, there were no differences in survival between BTB and BTT at 1 and 5 years posttransplant, as well as 10 years posttransplant even after adjusting for baseline characteristics. The extracorporeal membrane oxygenation BTB group had greater rates of acute rejection (32.8% vs 13.6%; P = .002) and lower rates of dialysis (1.6% vs 21.4%; P < .001). For intra-aortic balloon pump and temporary ventricular assist device patients, there were no differences in posttransplant length of stay, acute rejection, airway compromise, stroke, dialysis, or pacemaker insertion between BTB and BTT recipients. Conclusions: BTB patients have similar short- and midterm posttransplant survival as BTT patients. Future studies should continue to investigate the tradeoff between prolonged temporary mechanical circulatory support versus transitioning to durable mechanical circulatory support.

Posttransplant Long-Term Outcomes for Patients with Ventricular Assist Devices on the Heart Transplant Waitlist.

Ventricular assist devices (LVADs) are commonly used in end-stage heart failure for mechanical circulatory support as a bridge to heart transplantation. However, LVADs' long-term effects on posttransplant survival are unknown. We sought to compare long-term mortality after transplantation for patients with and without LVADs. Using the Organ Procurement and Transplantation Network database, we investigated LVADs' impact on long-term (3 month, 1 year, 2 years, 5 years, and 8 years) posttransplant mortality risk for all heart transplant recipients between 2010 and 2019. Time-to-event regression analysis quantified mortality risk by LVAD status in both unconditional and conditional survival analyses. Of 20,113 transplant recipients, 8,999 (45%) had a LVAD while on the waitlist. Among those who died after transplantation, patients with LVADs on average died sooner (1.8 years) than patients without LVADs (3.0 years; p < 0.01). On multivariable analysis, patients with LVADs had a 44% higher mortality risk within the first 3 months posttransplant (HR = 1.44, p = 0.03). There was no significant difference in mortality risk between patients who did and did not have pretransplant LVADs after 1, 2, and 5 years of posttransplant conditional survival. While LVAD patients have a survival disadvantage in the first year posttransplant, conditional survival analysis demonstrated no difference in mortality risk between patients with and without LVADs beyond 1 year of follow up. Of the patients who died posttransplant, patients with LVADs on average died sooner than patients without LVADs.

Failure to Rescue in Geriatric Trauma: The Impact of Any Complication Increases with Age and Injury Severity in Elderly Trauma Patients.

INTRODUCTION: The interaction of increasing age, Injury Severity Score (ISS), and complications is not well described in geriatric trauma patients. We hypothesized that failure to rescue rate from any complication worsens with age and injury severity. METHODS: The National Trauma Data Bank (NTDB) was queried for injured patients aged 65 years or older from January 1, 2013 through December 31, 2016. Demographics and injury characteristics were used to compare groups. Mortality rates were calculated across subgroups of age and ISS, and captured with heatmaps. Multivariable logistic regression was performed to identify independent predictors of mortality. RESULTS: 614,496 geriatric trauma patients were included; 151,880 (24.7%) experienced a complication. Those with complications tended to be older, female, non-white, have non-blunt mechanism, higher ISS, and hypotension on arrival. Overall mortality was highest (19%) in the oldest (≥86 years old) and most severely injured (ISS ≥ 25) patients, with constant age increasing across each ISS group was associated with a 157% increase in overall mortality (P < .001, 95% CI: 148-167%). Holding ISS stable, increasing age group was associated with a 48% increase in overall mortality (P < .001, 95% CI: 44-52%). After controlling for standard demographic variables at presentation, the existence of any complication was an independent predictor of overall mortality in geriatric patients (OR: 2.3; 95% CI: 2.2-2.4). CONCLUSIONS: Any complication was an independent risk factor for mortality, and scaled with increasing age and ISS in geriatric patients. Differences in failure to rescue between populations may reflect critical differences in physiologic vulnerability that could represent targets for interventions.

Association of operative approach with outcomes in neonates with esophageal atresia and tracheoesophageal fistula.

PURPOSE: We sought to evaluate the impact of thoracoscopic repair on perioperative outcomes in infants with esophageal atresia and tracheoesophageal fistula (EA/TEF). METHODS: The American College of Surgeons National Surgical Quality Improvement Program pediatric database from 2014 to 2018 was queried for all neonates who underwent operative repair of EA/TEF. Operative approach based on intention to treat was correlated with perioperative outcomes, including 30-day postoperative adverse events, in logistic regression models. RESULTS: Among 855 neonates, initial thoracoscopic repair was performed in 133 (15.6%) cases. Seventy (53%) of these cases were converted to open. Those who underwent thoracoscopic repair were more likely to be full-term (p = 0.03) when compared to those in the open repair group. There were no significant differences in perioperative outcome measures based on surgical approach except for operative time (thoracoscopic: 217 min vs. open: 180 min, p<0.001). A major cardiac comorbidity (OR 1.6, 95% CI 1.2-2.1; p = 0.003) and preoperative ventilator requirement (OR 1.4, 95% CI 1.0-1.9; p = 0.034) were the only risk factors associated with adverse events. CONCLUSIONS: Thoracoscopic neonatal repair of EA/TEF continues to be used sparingly, is associated with high conversion rates, and has similar perioperative outcomes when compared to open repair. LEVEL OF EVIDENCE: III.

Bridge to transplantation from mechanical circulatory support: a narrative review.

OBJECTIVE: To highlight recent developments in the utilization of mechanical circulatory support (MCS) devices as bridge-to-transplant strategies and to discuss trends in MCS use following the changes to the United Network for Organ Sharing (UNOS) heart allocation system. BACKGROUND: MCS devices have played an increasingly important role in the treatment of heart failure patients. Over the past several years, technological advancements have led to new developments in MCS devices and expanding indications for MCS use. In October of 2018, the UNOS heart allocation policy was revised to prioritize higher-urgency patients, including those supported with temporary MCS devices. Since then, changes in trends of MCS utilization have been observed. METHODS: Articles from the PubMed database regarding the use of MCS devices as bridge-to-transplant strategies were reviewed. CONCLUSIONS: Over the past decade, utilization of temporary MCS devices, which include the intra-aortic balloon pump (IABP), percutaneous ventricular assist devices (pVADs), and extracorporeal membrane oxygenation (ECMO), has become increasingly common. Recent advancements in MCS include the development of pVADs that can fully unload the left ventricle (LV) as well as devices designed to provide right-sided support. Technological advancements in durable left ventricular assist devices (LVADs) have also led to improved outcomes both on the device and following heart transplantation. Following the 2018 UNOS heart allocation policy revision, the utilization of temporary MCS in advanced heart failure patients has further increased and the proportion of patients bridged directly from a temporary MCS device has exponentially risen. However, following the start of the COVID-19 pandemic, the trends have reversed, with a decrease in the percentage of patients bridged from a temporary MCS device. As long-term data following the allocation policy revision becomes available, future studies should investigate how trends in MCS use for patients with advanced heart failure continue to evolve.

Patient Safety Indicators are an insufficient performance metric to track and grade outcomes of open aortic repair.

OBJECTIVE: National rankings of hospitals rely on outcomes-based evaluation to assess the performance of surgical programs, particularly those performing high-risk elective surgical procedures such as open aortic repair. Various classification systems exist for tracking outcomes, but increasingly the International Classification of Diseases, Tenth Revision-based Agency for Healthcare Research and Quality Patient Safety Indicators (PSIs) are used as a publicly reported comparison measure of hospital quality performance. We sought to critically evaluate the accuracy of the existing vehicles to assess open aortic repair outcomes in an established program. METHODS: This is a case-control study of patients who underwent open abdominal aortic aneurysm repair at the Johns Hopkins Medical Institutions from 2004 to 2018. Patients' characteristics and outcomes were collected as part of a prospectively maintained retrospective database. For each case, hemorrhagic, cardiac, respiratory, renal, wound, and thromboembolic complications were identified with the unique definitions used for open abdominal aortic aneurysm repair by the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) database, the Society for Vascular Surgery Vascular Quality Initiative (VQI) database, and the Agency for Healthcare Research and Quality PSI initiative. RESULTS: Of the 154 patients included in the study, 79 (51.0%) were identified as having a complication as defined by the VQI, 46 (29.7%) according to the NSQIP, and 15 (9.7%) according to the PSI system (P < .001). Patients most likely to incur a complication in the PSI system were those with a pararenal or more extensive aneurysm, with baseline congestive heart failure, requiring a supramesenteric clamp (all P < .01), or with an aneurysm >6.5 cm in diameter (P = .02). The NSQIP and VQI systems both identified more postoperative hemorrhagic, respiratory, renal, and wound complications than the PSI system did (P < .05). The VQI system identified the most renal complications (52; P < .001); factors unique to incurring a complication in the VQI include use of a suprarenal clamp and performance of an aortorenal bypass procedure as part of the repair (P < .01). Particularly weak correlation was noted between the PSI system and the VQI with respect to renal outcomes (ρ = 0.163). CONCLUSIONS: The PSI system identified fewer important complications than either of the clinically focused databases, with the VQI capturing the most postoperative events, mostly because of its stringent definition of renal injury. We conclude that the PSI system should not form the basis of grading hospital performance in comparing clinically relevant complications of open aortic surgery programs.

Poor concordance of contemporary performance measures in detecting complications in complex endovascular aortic repair.

BACKGROUND: The Agency for Healthcare Research and Quality Patient Safety Indicators (PSI) are quality improvement indicators used to determine hospital performance and, increasingly, to rank surgical programs. The American College of Surgeons National Surgical Quality Improvement Program and the Society for Vascular Surgery Vascular Quality Improvement databases are also frequently used to compare outcomes, but definitions of complications vary between the systems and the optimal system for tracking complications in complex endovascular repair remains unclear. Herein we assess the three outcome tracking systems and their ability to capture complications after fenestrated endovascular abdominal aortic aneurysm repair (FEVAR) and open aortic aneurysm repair in a large complex aortic program. METHODS: Demographic and operative data for patients undergoing repair of juxtarenal or pararenal aortic aneurysms between 2004 and 2018 via both open and FEVAR approaches at the Johns Hopkins Medical Institutions were compiled in a prospectively maintained retrospective database. Postoperative complications were defined according to a surgeon-defined system, the Society for Vascular Surgery Vascular Quality Initiative, the American College of Surgeons National Surgical Quality Improvement Program, and the Agency for Healthcare Research and Quality PSI data dictionaries and were compared between surgical approaches as well as eras before and after the introduction of FEVAR. Complication rates between the classification systems were compared using proportion testing and the strength of the correlation between the systems was evaluated with Spearman's rank test. RESULTS: Of 145 patients, 60 (41.4%) underwent FEVAR and 85 (58.6%) underwent open aortic aneurysm repair. The introduction of fenestrated technology was associated with a decrease in the overall number of complications from 37.2% to 20.6% by surgeon-defined classification system (P = .036). The VQI identified the most complications (39.9% of the entire cohort and 25% of FEVAR cases), followed by the NSQIP (29.0% and 33.3%, respectively) and PSI (4.1% and 5%). The two clinically focused databases were found to correlate well with a surgeon-designed classification system, as well as each other (Spearman ρ ≥ 0.735) but not with PSI (ρ < 0.23). Proportion testing demonstrated the rate of complications identified by PSI to be significantly less than either VQI or NSQIP (P < .001). Specifically, PSI did not effectively identify renal complications (1.4% vs 9.0% by NSQIP and 27.3% by VQI definitions; P < .001). CONCLUSIONS: The introduction of FEVAR is associated with an overall decrease in complications in this study. The clinically relevant VQI and NSQIP databases show good concordance in capturing complications; however, PSI did not correlate with either and captured significantly fewer complications. These data highlight the value of high scrutiny classification systems to track postoperative complications and suggest that PSI are insufficient to rank complex aortic programs with high levels of FEVAR use.

An Analysis of Waitlist Inactivity Among Patients With Ventricular Assist Devices.

BACKGROUND: Ventricular assist devices (VADs) are commonly used mechanical circulatory support for bridge to transplant therapy in end-stage heart failure; however, it is not understood how VADs influence incidence of waitlist inactive status. We sought to characterize and compare waitlist inactivity among patients with and without VADs. METHODS: Using the Organ Procurement and Transplantation Network database, we investigated the VAD's impact on incidence and length of inactive periods for heart transplant candidates from 2005 through 2018. We compared median length of inactivity between patients with and without VADs and investigated inactivity risk with time-to-event regression models. RESULTS: Among 46,441 heart transplant candidates, 32% (n = 14,636) had a VAD. Thirty-eight percent (n = 17,873) of all patients experienced inactivity, of which 42% (7538/17,873) had a VAD. Median inactivity length was 31 d for patients without VADs and 62 d for VAD patients (P < 0.0005). Multivariable analysis showed no significant difference in risk of inactivity for deteriorating conditions between patients with and without VADs after controlling for demographic and baseline clinical variables. A larger proportion of patients without VADs were inactive for deteriorating conditions than VAD patients (54%, n = 8242/15,221 versus 32%, n = 3583/11,086, P < 0.001). Ten percent (1155/11,086) of VAD patients' inactive periods were for VAD-related complications. CONCLUSIONS: Although VAD patients were inactive longer and had an overall increased risk of any-cause inactivity, their risk of inactivity for deteriorating condition was not significantly different from patients without VADs. Furthermore, VAD patients had a smaller proportion of inactivity periods due to deteriorating conditions. Thus, VADs are protective from morbidity for waitlist patients.

Ventricular assist devices and middle age reduce heart transplantation rates for waitlist candidates.

BACKGROUND: Ventricular assist devices (VADs) are commonly employed as a bridge to transplantation for heart failure. The full effects of VADs on transplantation rates are not fully understood. We sought to compare transplantation rates stratified by age and VAD status. METHODS: Using the Organ Procurement and Transplantation Network (OPTN) database, we investigated the impact of age and VAD status on heart allocation rates among all transplant-eligible patients from January 2005 to September 2018. Patients were grouped based on the presence (+) or absence (-) of a VAD as well as age (<45, 45-65, and >65 years). Demographics were compared with a multivariate competing risk analysis that yielded risk-adjusted subdistribution hazard ratios (SHR). RESULTS: Among the 50 602 total waitlist candidates, 18 271 patients with a VAD had higher rates of diabetes and cerebrovascular disease at waitlist entry. Multivariate analysis found statistically significant lower rates of transplantation for all (+)VAD groups compared with age-matched (-)VAD counterparts, with the 45- to 65-year-old (+)VAD group having the lowest transplantation rate (SHR = 0.62; P < .0005). Among (-)VAD patients, transplantation rates increased with increase in age. CONCLUSIONS: There is a statistically significant reduced rate of transplantation for patients with a VAD compared with those without a VAD, with the lowest rate among those of ages 45 to 65 years with a VAD. The increasing prevalence of this demographic and the deprioritization of VADs in the new heart allocation criteria have the potential to further exacerbate this difference.