Association of procurement technique with organ yield and cost following donation after circulatory death.

Donation after circulatory death (DCD) could account for the largest expansion of the donor allograft pool in the contemporary era. However, the organ yield and associated costs of normothermic regional perfusion (NRP) compared to super-rapid recovery (SRR) with ex-situ normothermic machine perfusion, remain unreported. The Organ Procurement and Transplantation Network (December 2019 to June 2023) was analyzed to determine the number of organs recovered per donor. A cost analysis was performed based on our institution's experience since 2022. Of 43 502 donors, 30 646 (70%) were donors after brain death (DBD), 12 536 (29%) DCD-SRR and 320 (0.7%) DCD-NRP. The mean number of organs recovered was 3.70 for DBD, 3.71 for DCD-NRP (P < .001), and 2.45 for DCD-SRR (P < .001). Following risk adjustment, DCD-NRP (adjusted odds ratio 1.34, confidence interval 1.04-1.75) and DCD-SRR (adjusted odds ratio 2.11, confidence interval 2.01-2.21; reference: DBD) remained associated with greater odds of allograft nonuse. Including incomplete and completed procurement runs, the total average cost of DCD-NRP was $9463.22 per donor. By conservative estimates, we found that approximately 31 donor allografts could be procured using DCD-NRP for the cost equivalent of 1 allograft procured via DCD-SRR with ex-situ normothermic machine perfusion. In conclusion, DCD-SRR procurements were associated with the lowest organ yield compared to other procurement methods. To facilitate broader adoption of DCD procurement, a comprehensive understanding of the trade-offs inherent in each technique is imperative.

Postoperative fibrinolytic resistance is associated with early allograft dysfunction in liver transplantation: A prospective observational study.

Perioperative dysfunction of the fibrinolytic system may play a role in adverse outcomes for liver transplant recipients. There is a paucity of data describing the potential impact of the postoperative fibrinolytic system on these outcomes. Our objective was to determine whether fibrinolysis resistance (FR), on postoperative day one (POD-1), was associated with early allograft dysfunction (EAD). We hypothesized that FR, quantified by tissue plasminogen activator thrombelastography, is associated with EAD. Tissue plasminogen activator thrombelastography was performed on POD-1 for 184 liver transplant recipients at a single institution. A tissue plasminogen activator thrombelastography clot lysis at 30 minutes of 0.0% was identified as the cutoff for FR on POD-1. EAD occurred in 32% of the total population. Fifty-nine percent (n=108) of patients were categorized with FR. The rate of EAD was 42% versus 17%, p <0.001 in patients with FR compared with those without, respectively. The association between FR and EAD risk was assessed using multivariable logistic regression after controlling for known risk factors. The odds of having EAD were 2.43 times (95% CI, 1.07-5.50, p =0.03) higher in recipients with FR [model C statistic: 0.76 (95% CI, 0.64-0.83, p <0.001]. An additive effect of receiving a donation after circulatory determination of death graft and having FR in the rate of EAD was observed. Finally, compared with those without FR, recipients with FR had significantly shorter graft survival time ( p =0.03). In conclusion, FR on POD-1 is associated with EAD and decreased graft survival time. Postoperative viscoelastic testing may provide clinical utility in identifying patients at risk for developing EAD, especially for recipients receiving donation after circulatory determination of death grafts.

Open innovation facilitates department-wide engagement in quality improvement: experience from the Massachusetts General Hospital.

BACKGROUND: Quality improvement (QI) initiatives commonly originate 'top-down' from senior leadership, as staff engagement is often sporadic. We describe our experience with a technology-enabled open innovation contest to encourage participation from multiple stakeholders in a Department of Surgery (DoS) to solicit ideas for QI. We aimed to stimulate engagement and to assist DoS leadership in prioritizing QI initiatives. METHODS: Observational study of a process improvement. The process had five phases: anonymous online submission of ideas by frontline staff; anonymous online crowd-voting to rank ideas on a scale whether the DoS should implement each idea (1 = No, 3 = Maybe, 5 = Yes); ideas with scores ≥ 95th percentile were invited to submit implementation plans; plans were reviewed by a multi-disciplinary panel to select a winning idea; an award ceremony celebrated the completion of the contest. RESULTS: 152 ideas were submitted from 95 staff (n = 850, 11.2%). All Divisions (n = 12) and all staff roles (n = 12) submitted ideas. The greatest number of ideas were submitted by faculty (27.6%), patient service coordinators (18.4%), and residents (17.8%). The most common QI category was access to care (20%). 195 staff (22.9%) cast 3559 votes. The mean score was 3.5 ± 0.5. 10 Ideas were objectively invited to submit implementation plans. One idea was awarded a grand prize of funding, project management, and leadership buy-in. CONCLUSION: A web-enabled open innovation contest was successful in engaging faculty, residents, and other critical role groups in QI. It also enabled the leadership to re-affirm a positive culture of inclusivity, maintain an open-door policy, and also democratically vet and prioritize solutions for quality improvement.

Is It Time to Reconsider the Milan Criteria for Selecting Patients With Hepatocellular Carcinoma for Deceased-Donor Liver Transplantation?

Liver transplantation (LT) is considered the optimal treatment for hepatocellular carcinoma (HCC) because it removes tumor as well as the underlying cirrhotic liver. Because of a global organ shortage, LT for patients with HCC is limited to patients with expected survival comparable to that of nonmalignant indications. Therefore, identifying patients with lower rates of HCC recurrence and higher rates of survival is critical. International guidelines have considered the Milan Criteria (MC) the standard for selecting patients with HCC for deceased-donor LT (DDLT). However, several alternative criteria have been reported in the Western world. Interestingly, the two most recent models combining α-fetoprotein level, number of nodules, and size of the largest nodule have been shown to outperform MC in identifying patients with low risk of HCC recurrence or those who will survive for 5 years after liver transplantation. In addition, new models overcome limitations of MC in improving classification of high- versus low-risk patients with HCC for DDLT. These recent scoring systems also provide clinicians with user-friendly tools to better identify patients at lower risk of recurrence. Conclusion: Although most Western countries still select patients based on MC, there is a mounting change in recent practice patterns regarding the selection of patients with HCC for DDLT. Herein, we describe how alternative criteria should lead to reconsideration of MC as it applies to selecting patients with HCC for DDLT in international guidelines.

Is the Power Threshold of 0.8 Applicable to Surgical Science?-Empowering the Underpowered Study.

BACKGROUND: Many articles in the surgical literature were faulted for committing type 2 error, or concluding no difference when the study was "underpowered". However, it is unknown if the current power standard of 0.8 is reasonable in surgical science. METHODS: PubMed was searched for abstracts published in Surgery, JAMA Surgery, and Annals of Surgery and from January 1, 2012 to December 31, 2016, with Medical Subject Heading terms of randomized controlled trial (RCT) or observational study (OBS) and limited to humans were included (n = 403). Articles were excluded if all reported findings were statistically significant (n = 193), or if presented data were insufficient to calculate power (n = 141). RESULTS: A total of 69 manuscripts (59 RCTs and 10 OBSs) were assessed. Overall, the median power was 0.16 (interquartile range [IQR] 0.08-0.32). The median power was 0.16 for RCTs (IQR 0.08-0.32) and 0.14 for OBSs (IQR 0.09-0.22). Only 4 studies (5.8%) reached or exceeded the current 0.8 standard. Two-thirds of our study sample had an a priori power calculation (n = 41). CONCLUSIONS: High-impact surgical science was routinely unable to reach the arbitrary power standard of 0.8. The academic surgical community should reconsider the power threshold as it applies to surgical investigations. We contend that the blueprint for the redesign should include benchmarking the power of articles on a gradient scale, instead of aiming for an unreasonable threshold.

Surgeon crossover between pediatric and adult centers is associated with decreased rate of loss to follow-up among adolescent renal transplantation recipients.

The risk of adverse outcomes for pediatric renal transplant patients is highest during the transition from pediatric to adult care. While there have been many studies focus on graft failure and death, loss to follow-up likely plays a large role in patient outcomes. We hypothesize patients are lost to follow-up during this transition period and that patients transplanted at pediatric centers with a closely affiliated adult center (AFFs) are less likely to suffer from fragmentation of care and become lost to follow-up. AFFs were defined as those pediatric centers whose transplant surgeons were also on staff at an adult center and were identified using center websites. We included patients undergoing renal transplantation at <=18 years of age and had data for the entire transition period on the Scientific Registry of Transplant Recipients (n = 6,762, 92.3% in 95 AFFs). 32% of patients were lost to follow-up. On regression, patients transplanted at AFF were 33% less likely to be lost to follow-up compared with those from non-AFF (OR 0.67 CI 0.54-0.82, P < 0.01). The proportion of patients lost to follow-up during the transition period is remarkably high, but lower among recipients transplanted at AFFs. Poor follow-up may be mitigated by improving integration of care.

Favorable impact of thoracic endovascular aortic repair on survival of patients with acute uncomplicated type B aortic dissection.

BACKGROUND: In uncomplicated type B aortic dissection (UTBAD), the "gold standard" has been nonoperative treatment with medical therapy, although this has been questioned by studies demonstrating improved outcomes in those treated with thoracic endovascular aortic repair (TEVAR). This study assessed long-term survival after acute UTBAD comparing medical therapy, open repair, and TEVAR. METHODS: The California Office of Statewide Hospital Planning Development database was analyzed from 2000 to 2010 for adult patients with acute UTBAD. Patients with nonemergent admission for aortic dissection, type A dissection, trauma, bowel ischemia, lower extremity ischemia, acidosis, or shock were excluded. The cohort was stratified by treatment type at index admission into medical therapy, open surgical repair, and TEVAR. Multivariable regression and survival analyses were used to evaluate the association of treatment type with long-term overall survival. RESULTS: There were 9165 cases, 95% medical therapy, 2% open repair, and 2.9% TEVAR. The mean age was 66 ± 15 years, with 39% female, 2.4% cocaine users, 18% with congestive heart failure, and 17% with Charlson Comorbidity Index >3. Mean inpatient costs were $57,000 for medical therapy, $200,000 for open repair, and $130,000 for TEVAR (P < .01). Inpatient mortality was 6.5% overall, 6.3% for medical therapy, 14% for open repair, and 7.1% for TEVAR (P < .01). One-year and 5-year survivals were 84% and 60% in medical therapy, 76% and 67% in open repair, and 85% and 76% in TEVAR (log-rank, P < .01). On risk-adjusted multivariable analysis, TEVAR had improved survival compared with medical therapy (hazard ratio, 0.68; 95% confidence interval, 0.6-0.8; P < .01), with no difference between open repair and medical therapy (hazard ratio, 1.0; 95% confidence interval, 0.8-1.3; P < .01). CONCLUSIONS: This statewide study on survival after acute UTBADs shows an independent survival advantage for TEVAR over medical therapy. These data add further evidence for a paradigm shift in acute management of type B dissection in favor of early TEVAR.

Reducing road traffic deaths: where should we focus global health initiatives?

BACKGROUND: Current global surgery initiatives focus on increasing surgical workforce; however, it is unclear whether this approach would be helpful globally, as patients in low-resource countries may not be able to reach hospitals in a timely fashion without formal Emergency Medical Services (EMS). We hypothesize that increased surgical workforce correlates with decreased road traffic deaths (RTDs) only in countries with EMS. METHODS: Estimated RTDs were obtained from the Global Status Report on Road Safety 2013, which estimated the RTD rate in 2010 (RTD 2010). The classification of EMS was defined by the Global Status Report on Road Safety 2009. The density of surgeons, anesthesiologists, and obstetricians (SAO density) and 2010 income classification were accessed from the World Bank. Multivariable regression analysis was performed adjusting for different countries, income levels, and trauma system characteristics. Sensitivity analysis was performed. RESULTS: One-fourth of the countries reported not having formal EMS (n = 41, 23.4%). On adjusted analysis, SAO density was not associated with changes in RTD 2010 in countries without EMS (n = 25, P = 0.50). However, in countries with EMS, each increase in SAO density per 100,000 population decreased RTDs by 0.079 per 100,000 population (n = 97, P <0.001). Income was the only other factor resulting in reduced mortality rates (P = 0.004). Sensitivity analysis confirmed these findings. CONCLUSIONS: Increases in surgical workforce reduce RTDs only when EMS exist. Surgical workforce and EMS must be seen as part of the same system and developed together to maximize their effect in reducing RTDs. Global health initiatives should be tailored to individual country need. LEVEL OF EVIDENCE: Level II (Ecological study).

Pediatric kidney transplantation and mortality: Distance to transplant center matters.

Distance from pediatric kidney transplant centers may be a significant barrier in accessing care for patients and families, particularly due to the lower number of pediatric kidney transplant centers compared with the number of adult centers. We performed a retrospective cohort study using data from the Scientific Registry of Transplant Recipients to determine the effect of distance on pediatric kidney transplant waitlist outcomes. We found that distance did not play a role in the likelihood of transplantations for patients who were placed on the waitlist. However, living a greater distance from the transplant center was associated with a greater risk of death while on the waitlist. Larger volume centers attracted patients from greater distances, many of whom had other centers closer to their home. Further investigation on the role of distance to transplant center and the likelihood of being evaluated and listed for a kidney transplant would elucidate whether there are additional barriers these patients face.

How Much Data are Good Enough? Using Simulation to Determine the Reliability of Estimating POMR for Resource-Constrained Settings.

INTRODUCTION: Perioperative mortality rate (POMR) is a suggested indicator for surgical quality worldwide. Currently, POMR is often sampled by convenience; a data-driven approach for calculating sample size has not previously been attempted. We proposed a novel application of a bootstrapping sampling technique to estimate how much data are needed to be collected to reasonably estimate POMR in low-resource countries where 100% data capture is not possible. MATERIAL AND METHODS: Six common procedures in low- and middle-income countries were analysed by using population database in New York and California. Relative margin of error by dividing the absolute margin of error by the true population rate was calculated. Target margin of error was ±50%, because this level of precision would allow us to detect a moderate-to-large effect size. RESULTS AND DISCUSSION: Target margin of error was achieved at 0.3% sampling size for abdominal surgery, 7% for fracture, 10% for craniotomy, 16% for pneumonectomy, 26% for hysterectomy and 60% for C-section. POMR may be estimated with fairly good reliability with small data sampling. This method demonstrates that it is possible to use a data-driven approach to determine the necessary sampling size to accurately collect POMR worldwide.

Is Annual Volume Enough? The Role of Experience and Specialization on Inpatient Mortality After Hepatectomy.

OBJECTIVE: To investigate the effect of subspecialty practice and experience on the relationship between annual volume and inpatient mortality after hepatic resection. BACKGROUND: The impact of annual surgical volume on postoperative outcomes has been extensively examined. However, the impact of cumulative surgeon experience and specialty training on this relationship warrants investigation. METHODS: The New York Statewide Planning and Research Cooperative System inpatient database was queried for patients' ≥18 years who underwent wedge hepatectomy or lobectomy from 2000 to 2014. Primary exposures included annual surgeon volume, surgeon experience (early vs late career), and surgical specialization-categorized as general surgery (GS), surgical oncology (SO), and transplant (TS). Primary endpoint was inpatient mortality. Hierarchical logistic regression was performed accounting for correlation at the level of the surgeon and the hospital, and adjusting for patient demographics, comorbidities, presence of cirrhosis, and annual surgical hospital volume. RESULTS: A total of 13,467 cases were analyzed. Overall inpatient mortality was 2.35%. On unadjusted analysis, late career surgeons had a mortality rate of 2.62% versus 1.97% for early career surgeons. GS had a mortality rate of 2.98% compared with 1.68% for SO and 2.67% for TS. Once risk-adjusted, annual volume was associated with reduced mortality only among early-career surgeons (odds ratio 0.82, P = 0.001) and general surgeons (odds ratio 0.65, P = 0.002). No volume effect was seen among late-career or specialty-trained surgeons. CONCLUSIONS: Annual volume alone likely contributes only a partial assessment of the volume-outcome relationship. In patients undergoing hepatic resection, increased annual volume did not confer a mortality benefit on subspecialty surgeons or late career surgeons.

Distance is associated with mortality on the waitlist in pediatric liver transplantation.

The distance to liver transplant centers affects outcomes in adult liver transplantation. Because pediatric patients are particularly vulnerable, we hypothesized that distance adversely affects the time to transplantation and waitlist mortality. The SRTR was queried for isolated pediatric liver transplant registrants (under age 18) with valid ZIP code information from 2003 to 2012. Distance was measured from home ZIP code to listing transplant center. Competing events analysis, adjusted for demographic factors, indication, and PELD, was undertaken for transplantation and death while on the waitlist. The median distance to listing transplant center for 6924 children was 65 (IQR 17.5-189) miles. Median distance traveled increased by listing volume (73.9 vs 33.8 miles, highest vs lowest volume quartile, P<.001 for trend) and varied across the country. Longer distance was not associated with time to transplantation (HR 0.99, longest vs shortest distance quartile, P=.80), but was associated with increased mortality (HR 1.75, P<.001). Larger centers attract patients from a distance, while smaller centers serve local populations. Increasing distance is associated with a higher risk of waitlist death, which may reflect decreased access to specialist and tertiary care associated with a transplant center.

Differential in Kidney Graft Years on the Basis of Solitary Kidney, Simultaneous Liver-Kidney, and Kidney-after-Liver Transplants.

BACKGROUND: The number of simultaneous liver-kidney (SLK) transplants has significantly increased in the United States. There has also been an increase in kidney-after-liver transplants associated with 2017 policy revisions aimed to fairly allocate kidneys after livers. SLK and kidney-after-liver candidates are prioritized in allocation policy for kidney offers ahead of kidney-alone candidates. METHODS: We compared kidney graft outcomes of kidney-alone transplant recipients with SLK and kidney-after-liver transplants using paired kidney models to mitigate differences among donor risk factors. We evaluated recipient characteristics between transplant types and calculated differential graft years using restricted mean survival estimates. RESULTS: We evaluated 3053 paired donors to kidney-alone and SLK recipients and 516 paired donors to kidney-alone and kidney-after-liver recipients from August 2017 to August 2022. Kidney-alone recipients were younger, more likely on dialysis, and Black race. One-year and 3-year post-transplant kidney graft survival for kidney-alone recipients was 94% and 86% versus SLK recipients 89% and 80%, respectively, P < 0.001. One-year and 3-year kidney graft survival for kidney-alone recipients was 94% and 84% versus kidney-after-liver recipients 93% and 87%, respectively, P = 0.53. The additional kidney graft years for kidney-alone versus SLK transplants was 21 graft years/100 transplants (SEM=5.0) within 4 years post-transplantation, with no significant difference between kidney-after-liver and kidney-alone transplants. CONCLUSIONS: Over a 5-year period in the United States, SLK transplantation was associated with significantly lower kidney graft survival compared with paired kidney-alone transplants. Most differences in graft survival between SLK and kidney-alone transplants occurred within the first year post-transplantation. By contrast, kidney-after-liver transplants had comparable graft survival with paired kidney-alone transplants.

Ventricular Remodeling Following Metabolic and Bariatric Surgery Decreases Need for Heart Transplantation: A Predictive Model.

PURPOSE: For patients with obesity and congestive heart failure (CHF) who require heart transplantation (HT), aggressive weight loss has been associated with ventricular remodeling, or subclinical alterations in left and right ventricular structure that affect systolic function. Many have suggested offering metabolic and bariatric surgery (MBS) for these patients. As such, we evaluated the role of MBS in HT for patients with obesity and CHF using predictive modelling techniques. MATERIALS AND METHODS: Markov decision analysis was performed to simulate the life expectancy of 30,000 patients with concomitant obesity, CHF, and 30% ejection fraction (EF) who were deemed ineligible to be waitlisted for HT unless they achieved a BMI < 35 kg/m2. Life expectancy following diet and exercise (DE), Roux-en-Y gastric bypass (RYGB), and sleeve gastrectomy (SG) was estimated. Base case patients were defined as having a pre-intervention BMI of 45 kg/m2. Sensitivity analysis of initial BMI was performed. RESULTS: RYGB patients had lower rates of HT and received HT quicker when needed. Base case patients who underwent RYGB gained 2.2 additional mean years survival compared with patients who underwent SG and 10.3 additional mean years survival compared with DE. SG patients gained 6.2 mean years of life compared with DE. CONCLUSION: In this simulation of 30,000 patients with obesity, CHF, and reduced EF, MBS was associated with improved survival by not only decreasing the need for transplantation due to improvements in EF, but also increasing access to HT when needed due to lower average BMI.

The vexing triad of obesity, alcohol, and coagulopathy predicts the need for multiple operations in liver transplantation.

INTRODUCTION: One in four liver transplants (LT) require return to the operating room(R-OR) within 48 h of surgery. We hypothesize that donor, recipient, and intraoperative factors will predict R-OR. METHODS: LT recipients were enrolled in an observational study to measure coagulation with thrombelastography (TEG) were assessed with transplant recipient and donor variables for risk of R-OR. RESULTS: 160 recipients with a median age of 55 years and a MELD-Na of 22 were analyzed. R-OR occurred in 22%. Recipient BMI (p = 0.006), donor heavy alcohol use (p = 0.017), TEG MA (p = 0.013) during the anhepatic phase of surgery, TEG MA at anhepatic and 30-min after reperfusion (p < 0.05), and red blood cell transfusions (p < 0.001) were associated with R-OR. CONCLUSION: The vexing triad of recipient obesity, heavy donor alcohol use, and low TEG MA were associated with a high rate of R-OR. Strategies to reduce this sub-optimal combination of risk factors could reduce the frequency of unplanned re-operations.

Do Social Determinants Define "Too Sick" to Transplant in Patients With End-stage Liver Disease?

BACKGROUND: Delisting for being "too sick" to be transplanted is subjective. Previous work has demonstrated that the mortality of patients delisted for "too sick" is unexpectedly low. Transplant centers use their best clinical judgment for determining "too sick," but it is unclear how social determinants influence decisions to delist for "too sick." We hypothesized that social determinants and Donor Service Area (DSA) characteristics may be associated with determination of "too sick" to transplant. METHODS: Data were obtained from the Scientific Registry of Transplant Recipients for adults listed and removed from the liver transplant waitlist from 2002 to 2017. Patients were included if delisted for "too sick." Our primary outcome was Model for End-Stage Liver Disease (MELD) score at waitlist removal for "too sick." Regression assessed the association between social determinants and MELD at removal for "too sick." RESULTS: We included 5250 delisted for "too sick" at 127 centers, in 53 DSAs, over 16 years. The mean MELD at delisting for "too sick" was 25.8 (SD ± 11.2). On adjusted analysis, social determinants including age, race, sex, and education predicted the MELD at delisting for "too sick" (P < 0.05). CONCLUSIONS: There is variation in delisting MELD for "too sick" score across DSA and time. While social determinants at the patient and system level are associated with delisting practices, the interplay of these variables warrants additional research. In addition, center outcome reports should include waitlist removal rate for "too sick" and waitlist death ratios, so waitlist management practice at individual centers can be monitored.