Risk-adjusted Analysis Research Articles

Does It Pay to Wait? Quantifying the National Longitudinal Morbidity and Healthcare Use after Emergent Paraesophageal Hernia Repair

INTRODUCTION: Elective paraesophageal hernia repair (PEHR) is a relatively safe intervention. Current guidelines recommend an expectant approach toward asymptomatic PEH, but many patients present with acute symptoms requiring emergent surgery. We quantified the longitudinal morbidity and healthcare use after emergent PEHR relative to elective cases nationwide. METHODS: Adult patients undergoing repair for symptomatic PEH with follow-up >6 months were identified using the Nationwide Readmission Database (2010 to 2019). Postoperative complication, mortality, unplanned readmission, reintervention, and cost within 1 year were compared by acuity (emergent vs elective) using risk-adjusted regression modeling. The association of outcomes by approach (minimally invasive [MI-PEHR] vs open-PEHR) was also explored. RESULTS: There were 43,243 PEHR cases: 76.0% emergent and 78.2% MI-PEHR. Most undergoing emergent PEHR were aged >65 years (58.5%), female (71.3%), and underwent operation at high-volume centers (>p75th 60.1%). Risk-adjusted analyses showed increased complication (hazard ratio [HR] 1.14 [1.04 to 1.24]), readmission, (HR 1.14 [1.03 to 1.26]), and cost for emergent PEHR (Ref. elective; all p < 0.05; Table 1). Within risk-adjusted regression models, emergent open-PEHR was associated with increased complication (HR 1.27 [1.2 to 1.36]), mortality (HR 1.25 [1.02 to 1.54]), and costs (Ref. MI-PEHR; (all p < 0.01). Estimated national aggregate cost for index admission and subsequent hospitalization after PEHR was $257 million/y with 81.4% related to emergent cases.Table 1CONCLUSION: Emergent PEHR is associated with increased morbidity and healthcare use due to postoperative complication and readmission, but MI-PEHR is associated with decreased morbidity even in the emergent setting. The need to prevent emergent cases should warrant further work aimed at clarifying the current indications for elective PEHR.

Early and mid-term outcome of patients with low-flow-low-gradient aortic stenosis treated with newer-generation transcatheter aortic valves.

Patients with non-paradoxical low-flow–low-gradient (LFLG) aortic stenosis (AS) are at increased surgical risk, and thus, they may particularly benefit from transcatheter aortic valve replacement (TAVR). However, data on this issue are still limited and based on the results with older-generation transcatheter heart valves (THVs). The aim of this study was to investigate early and mid-term outcome of TAVR with newer-generation THVs in the setting of LFLG AS. Data for the present analysis were gathered from the OBSERVANT II dataset, a national Italian observational, prospective, multicenter cohort study that enrolled 2,989 consecutive AS patients who underwent TAVR at 30 Italian centers between December 2016 and September 2018, using newer-generation THVs. Overall, 420 patients with LVEF ≤50% and mean aortic gradient <40 mmHg were included in this analysis. The primary outcomes were 1-year all-cause mortality and a combined endpoint including all-cause mortality and hospital readmission due to congestive heart failure (CHF) at 1 year. A risk-adjusted analysis was performed to compare the outcome of LFLG AS patients treated with TAVR (n = 389) with those who underwent surgical aortic valve replacement (SAVR, n = 401) from the OBSERVANT I study. Patients with LFLG AS undergoing TAVR were old (mean age, 80.8 ± 6.7 years) and with increased operative risk (mean EuroSCORE II, 11.5 ± 10.2%). VARC-3 device success was 83.3% with 7.6% of moderate/severe paravalvular leak. Thirty-day mortality was 3.1%. One-year all-cause mortality was 17.4%, and the composite endpoint was 34.8%. Chronic obstructive pulmonary disease (HR 1.78) and EuroSCORE II (HR 1.02) were independent predictors of 1-year mortality, while diabetes (HR 1.53) and class NYHA IV (HR 2.38) were independent predictors of 1-year mortality or CHF. Compared with LFLG AS treated with SAVR, TAVR patients had a higher rate of major vascular complications and permanent pacemaker, while SAVR patients underwent more frequently to blood transfusion, cardiogenic shock, AKI, and MI. However, 30-day and 1-year outcomes were similar between groups. Patients with non-paradoxical LFLG AS treated by TAVR were older and with higher surgical risk compared with SAVR patients. Notwithstanding, TAVR was safe and effective with a similar outcome to SAVR at both early and mid-term.

Pediatric trauma mortality in India and the United States: A comparison and risk-adjusted analysis

BackgroundThere is a paucity of research comparing pediatric risk-adjusted trauma mortality between high-income and low- and middle-income countries. This limits identification of populations and injury patterns for targeted interventions. We aim to compare independent predictors of pediatric trauma mortality between India and the United States (US). MethodsA retrospective cohort study was conducted for pediatric patients (age <18 years) in India's Towards Improved Trauma Care Outcomes (TITCO) project database and the US National Trauma Data Bank (NTDB) from 2013 to 2015. Demographic, injury, physiologic, anatomic and outcome data were analyzed. Multivariable regressions were used to determine independent predictors of mortality. Results126,678 pediatric trauma patients were included (India 3,373; US 123,305). Pediatric patients in India were on average significantly younger, with a higher median injury severity score (ISS), had lower systolic blood pressure, and suffered a higher case fatality rate (13.0% vs. 1.0%). When controlling for demographic, mechanism, physiologic, and anatomic injury characteristics, sustaining an injury in India was the strongest predictor of mortality (OR 22.70, 95% CI 18.70–27.56). On subgroup analysis, the highest relative odds of mortality in India was seen in children with lower injury and physiologic severity. ConclusionsRisk-adjusted pediatric trauma-related mortality is significantly higher in India compared to the US. The comparative odds of mortality are highest among children with lower injury and physiologic severity. This suggests that low-cost targeted interventions focused on standard timely trauma care, protocols, training and early imaging could improve pediatric injury mortality in India. Type of StudyRetrospective Prognosis Study Level of EvidenceII

Trends and outcomes of percutaneous coronary intervention during the COVID-19 pandemic in Michigan.

The COVID-19 pandemic has severely impacted healthcare delivery and patient outcomes globally. We aimed to evaluate the influence of the COVID-19 pandemic on the temporal trends and outcomes of patients undergoing percutaneous coronary intervention (PCI) in Michigan. We compared all patients undergoing PCI in the BMC2 Registry between March and December 2020 ("pandemic cohort") with those undergoing PCI between March and December 2019 ("pre-pandemic cohort"). A risk-adjusted analysis of in-hospital outcomes was performed between the pre-pandemic and pandemic cohort. A subgroup analysis was performed comparing COVID-19 positive vs. negative patients during the pandemic. There was a 15.2% reduction in overall PCI volume from the pre-pandemic (n = 25,737) to the pandemic cohort (n = 21,822), which was more pronounced for stable angina and non-ST-elevation acute coronary syndromes (ACS) presentations, and between February and May 2020. Patients in the two cohorts had similar clinical and procedural characteristics. Monthly mortality rates for primary PCI were generally higher in the pandemic period. There were no significant system delays in care between the cohorts. Risk-adjusted mortality was higher in the pandemic cohort (aOR 1.26, 95% CI 1.07-1.47, p = 0.005), a finding that was only partially explained by worse outcomes in COVID-19 patients and was more pronounced in subjects with ACS. During the pandemic, COVID-19 positive patients suffered higher risk-adjusted mortality (aOR 5.69, 95% CI 2.54-12.74, p<0.001) compared with COVID negative patients. During the COVID-19 pandemic, we observed a reduction in PCI volumes and higher risk-adjusted mortality. COVID-19 positive patients experienced significantly worse outcomes.

The taTME learning curve for mid-low rectal cancer: a single-center experience in China

PurposeAs transanal total mesorectal excision (taTME) is performed worldwide, the optimization of existing training and guidance programs to enhance new taTME learners’ competence in performing this procedure is warranted. This study aimed to evaluate the taTME learning curve in patients with mid-low rectal cancer.MethodsPatients who underwent taTME for mid-low rectal cancer between October 2015 and August 2021 at a single center were included. A cumulative sum (CUSUM) learning curve analysis was performed with the total operation time as the study outcome. The learning curve was analyzed using risk-adjusted CUSUM analysis, with postoperative complications and anastomotic leakage (AL) as outcomes.ResultsIn total, 104 consecutive patients were included in this study. The CUSUM learning curve for total operative time started declining after 42 cases (309.1 ± 84.4 vs. 220.2 ± 46.4, P < 0.001). The risk-adjusted CUSUM (RA-CUSUM) learning curve for postoperative complications fluctuated in cases 44–75 and declined significantly after case 75. The RA-CUSUM learning curve for AL declined after 68 cases.ConclusionstaTME had learning curves of 42, 75, and 68 cases for total operative time, postoperative complications, and AL, respectively. A surgeon may require 42 and 75 cases to achieve “proficiency” and “mastery” in taTME procedures, respectively.

Portfolio Spiking with Cryptocurrency: A Risk-Adjusted Performance Analysis

The objective of this study is to provide empirical documentation on the risk-adjusted performance of portfolios formed by investing in a Cryptocurrency such as Bitcoin and a risk-free asset. The study evaluates the performance of these Bitcoin-spiked portfolios using statistical measures grounded in modern portfolio theory. Market returns are adjusted for the degree of total risk, systematic risk, and downside risk inherent in each portfolio, and the securities are then ranked on the basis of risk-adjusted performance. In addition to standard Sharpe, Jensen, and Treynor performance measures, two newer evaluation metrics, the Modigliani and Sortino measures, are used for ranking the portfolios. We report that these portfolios have varying levels of risk and return. Our key finding is that these portfolios’ risk-adjusted returns are not only quite impressive but also exceed that of S&amp;P 500, our benchmark market portfolio. The implication of our results is that investors with higher risk tolerance could earn substantially higher returns by including a larger percentage of Bitcoin in their portfolios. Our results should be informative to individual and institutional investors contemplating investing in cryptocurrencies but aware of their high risk.

Massive blood transfusion following older adult trauma: The effect of blood ratios on mortality.

Massive blood transfusion (MBT) following older adult trauma poses unique challenges. Despite extensive evidence on optimal resuscitative strategies in the younger adult patients, there is limited research in the older adult population. We used the Trauma Quality Improvement Program (TQIP) database from 2013 to 2017 to identify all patients over 65 years old who received a MBT. We stratified our population into six fresh-frozen plasma:packed red blood cell (FFP:pRBC) ratio cohorts (1:1, 1:2, 1:3, 1:4, 1:5, 1:6+). Our primary outcomes were 24-h and 30-day mortality. We constructed multivariable regression models with 1:1 group as the baseline and adjusted for confounders to estimate the independent effect of blood ratios on mortality. A total of 3134 patients met our inclusion criteria (median age 73 ± 7.6 years, 65% male). On risk-adjusted multivariable analysis, 1:1 FFP:pRBC ratio was independently associated with lowest 24-h mortality (1:2 odds ratio [OR]1.60, 95% confidence interval [CI]1.25-2.06, p < 0.001) and 30-day mortality (1:2 OR 1.44, 95% CI 1.15-1.80, p=0.002). Compared to all other ratios, the 1:1 FFP:pRBC ratio had the lowest 24-h and 30-day mortality following older adult trauma consistent with findings in the younger adult population.

Learning Curve and Complications of Unilateral Biportal Endoscopy: Cumulative Sum and Risk-Adjusted Cumulative Sum Analysis.

ObjectiveThe purpose of this study was to investigate the learning curve and complications of unilateral biportal endoscopy (UBE) in the treatment of lumbar disc herniation (LDH) and lumbar spinal stenosis (LSS). MethodsThis was a retrospective cohort analysis of 197 consecutive patients who received UBE unilateral laminotomy bilateral decompression (UBE-ULBD) or lumbar discectomy (UBE-LD) surgery, including 107 males and 90 females with an average age of 64.83±14.29 years. Cumulative sum (CUSUM) and risk-adjusted cumulative sum analysis (RA-CUSUM) were used to evaluate the learning curve, with the occurrence of complications defined as surgical failure, and variables of different phase of the learning curve were compared. ResultsThe cutoff point of learning curve of UBE surgery was 54 cases according to CUSUM analysis. The learning curve of UBE-ULBD and UBE-LD were divided into 3 phases. The first cutoff points were 31 and 12 cases, and the second cutoff point were 67 and 32 cases respectively. With the progress of the learning curve, the operation time and postoperative hospital stays decreased. The visual analogue scale and Oswestry Disability Index at the last follow-up were significantly lower than that before surgery. The incidence of surgical failure was 6.11% and began to decrease after the 89th case based on RA-CUSUM analysis. The surgical failure rate decreased from 10.11% to 2.78 after the 89th case with significant different. ConclusionUBE surgery is effective in the treatment of LDH and LSS with low incidence of complications. But a learning curve of at least 54 cases still required for mastering UBE surgery.

Early Reexploration for Bleeding Is Associated With Improved Outcome in Cardiac Surgery

BackgroundReexploration after cardiac surgery, most frequently for bleeding, is a quality metric used to assess surgical performance. This may cause surgeons to delay return to the operating room in favor of attempting nonoperative management. This study investigated the impact of the timing of reexploration on morbidity and mortality. MethodsThis study was a single-institution retrospective review of all adult cardiac surgery patients from July 2010 to June 2020. Time to reexploration was assessed, and outcomes were compared across increasing time intervals. Reported bleeding sites were classified into 5 groups, and bleeding rate (chest tube output) was compared across bleeding sites. Univariable analysis was performed using the Fisher exact and Kruskal-Wallis tests. Multivariable logistic regression models were used for risk-adjusted analyses. ResultsOf 10 070 eligible patients, 251 (2.5%) required reexploration for postoperative bleeding. The most common site of bleeding was “any suture line” (n = 70; 28%). Interestingly, in 30% of cases (n = 75) “no active bleeding” site was reported. The highest rate of bleeding (mL/h) was observed in the “any mediastinal structure” group (median, 450; interquartile range [IQR], 185, 8878), and the lowest rate was noted in the “no active bleeding” group (median, 151.2; IQR, 102, 270). Both morbidity rates (0-4 hours, 12.3% vs 25-48 hours, 37.5%; P = .001) and mortality rates (0-4 hours, 3.1% vs 25-48 hours, 43.8%; P = .001) escalated significantly with increasing time to reexploration. ConclusionsDelayed reexploration for bleeding after cardiac surgery is associated with increased risk for morbidity and mortality. Early surgical intervention, particularly within 4 hours, may improve outcomes. Implications from using reoperation as a performance metric may lead to unnecessary delay and patient harm.

Implementation of a non–intensive-care unit medical emergency team improves failure to rescue rates in cardiac surgery patients

ObjectiveFailure to rescue (FTR) is an emerging measure in cardiac surgery, defined as mortality after a postoperative complication. We hypothesized that establishing a medical emergency team (MET) reduced rates of FTR in adults undergoing cardiac surgery. MethodsAll patients (N = 11,218) undergoing a The Society of Thoracic Surgeons index operation at our center (1994-2018) were stratified by pre-MET or MET era based on the 2009 institutional implementation of a MET to respond to clinical decompensation in non–intensive-care patients. Patients missing The Society of Thoracic Surgeons predicted risk of mortality were excluded from all cohorts. Risk adjusted multivariable regression analyzed the association of postoperative complications, operative mortality, and FTR by era. Nearest neighbor propensity score matching utilizing patients' The Society of Thoracic Surgeons predicted risk of mortality was performed to create balanced control and exposure groups for secondary subgroup analysis. ResultsIn the risk-adjusted multivariable analysis, surgery during the MET era was associated with decreased mortality (odds ratio [OR], 0.51; 95% CI, 0.45-0.77; P < .001), postoperative renal failure (OR, 0.57; 95% CI, 0.46-0.70; P < .001), reoperation (OR, 0.75; 95% CI, 0.59-0.95; P = .017), and deep sternal wound infection (OR, 0.16; 95% CI, 0.04-0.45; P = .002). Surgery performed during the MET era was associated with a decreased rate of FTR in the risk-adjusted analysis (OR, 0.46; 95% CI, 0.34-0.70; P < .001). ConclusionsThe development of an institutional MET program was associated with a decrease in major complications and FTR. These findings support the development of MET programs to improve FTR after cardiac surgery.

EQIP's First Year: A Step Closer to Higher Quality in Surgical Education

To describe the first year of the Educational Quality Improvement Program (EQIP) DESIGN: The Educational Quality Improvement Program (EQIP) was formed by the Association of Program Directors in Surgery (APDS) in 2018 as a continuous educational quality improvement program. Over 18 months, thirteen discrete goals for the establishment of EQIP were refined and executed through a collaborative effort involving leaders in surgical education. Alpha and beta pilots were conducted to refine the data queries and collection processes. A highly-secure, doubly-deidentified database was created for the ingestion of resident and program data. 36 surgical training programs with 1264 trainees and 1500 faculty members were included in the dataset. 51,516 ERAS applications to programs were also included. Uni- and multi-variable analysis was then conducted. EQIP was successfully deployed within the timeline described in 2020. Data from the ACGME, ABS, and ERAS were merged with manually entered data by programs and successfully ingested into the EQIP database. Interactive dashboards have been constructed for use by programs to compare to the national cohort. Risk-adjusted multivariable analysis suggests that increased time in a technical skills lab was associated with increased success on the ABS's Qualifying Examination, alone. Increased time in a technical skills lab and the presence of a formal teaching curriculum were associated with increased success on both the ABS's Qualifying and Certifying Examination. Program type may be of some consequence in predicting success on the Qualifying Examination. The APDS has proved the concept that a highly secure database for the purpose of continuous risk-adjusted quality improvement in surgical education can be successfully deployed. EQIP will continue to improve and hopes to include an increasing number of programs as the barriers to participation are overcome.

Transcatheter and Surgical Aortic Valve Replacement in Patients With Bicuspid Aortic Valve Stenosis

BackgroundTranscatheter aortic valve replacement (TAVR) is not widely used in patients with bicuspid aortic valve (BAV) disease and has not yet been studied in randomized clinical trials. We characterized the rate of use and outcomes of TAVR and surgical aortic valve replacement (SAVR) in patients with BAV. MethodsAdults with BAV stenosis receiving SAVR or TAVR procedures were abstracted from the 2012 to 2019 Nationwide Readmissions Database (NRD). Risk-adjusted analyses were performed with NRD-provided weights and inverse probability of treatment weights (IPTW) to examine the association of treatment strategy on inpatient mortality, complications, and hospitalization resource utilization. Nonelective readmissions within 90 days of discharge and reintervention at the first readmission were also examined. ResultsOf an estimated 56 331 patients with BAV requiring aortic valve replacement, 6.8% underwent TAVR. Unadjusted analysis demonstrated higher index hospitalization mortality for TAVR compared with SAVR. Upon risk adjustment using NRD-provided weights, the odds of pacemaker implantation remained significantly higher for TAVR patients compared with SAVR, with no significant difference in mortality. When NRD-provided survey weights were applied, TAVR had higher rates of 90-day readmission. Adjustment with inverse probability of treatment weights resolved these differences between the 2 groups. Regardless of the risk-adjustment method, the odds of reintervention were consistently higher among BAV TAVR patients compared with SAVR. ConclusionsThe present analysis demonstrates comparable in-hospital mortality and morbidity for TAVR and SAVR patients in the moderate-risk era. With increasing TAVR use in BAV, surgeons must further refine selection criteria with consideration of concomitant aortopathy and implications of reintervention.

Outcomes of Mitral Valve Repair Among High- and Low-Volume Surgeons Within a High-Volume Institution

BackgroundVolume-outcome relationships have been described for mitral valve repair at the institution and surgeon level. We aimed to assess whether this relationship is mitigated at high-volume (HV) mitral repair centers between HV and low-volume (LV) surgeons. MethodsAll mitral repair cases at an HV mitral center (mean, 192 annual repairs) from 1992 to 2018 were considered. Cases with concomitant procedures other than tricuspid and atrial fibrillation procedures were excluded. Surgeons who performed ≥25 repairs per year were considered HV. The primary outcome was operative mortality; secondary outcomes were operative complications, long-term mortality, and reoperation. ResultsIn total, 2653 mitral repairs from 19 surgeons were included. The mean age of the patients in the HV and LV groups was 59.6 years and 61.8 years, respectively (P = .005), with no difference in other baseline characteristics. HV surgeons had significantly shorter median aortic cross-clamp times (80 vs 87 minutes; P < .001) compared with LV surgeons; however, there was no significant difference in operative mortality (0.9% vs 1.6%; P = .19), reoperation, perioperative complications, or length of stay. LV surgeons had higher repair conversion to replacement than HV surgeons did (9.0% vs 3.4%; P < .001). In the risk-adjusted analyses, surgeon volume group did not have an impact on longitudinal survival or reoperation. ConclusionsAt an HV mitral repair institution, LV surgeons appear to have short- and long-term outcomes similar to those of HV surgeons despite increased conversion rates. These findings suggest that institutional volume may mitigate the surgeon volume outcome. However, complex repairs may benefit from referral to HV surgeons, given the lower conversion rate.

P1068: RISK-ADJUSTED SAFETY ANALYSIS OF PACRITINIB IN PATIENTS WITH MYELOFIBROSIS

Background: Pacritinib is a novel JAK2/IRAK1 inhibitor that has shown clinically significant activity in patients with myelofibrosis, including those with platelet counts <50 x 109/L. Recently, JAK inhibitors have come under increased scrutiny due to specific, emerging toxicities with drugs in this class. Aims: This safety analysis focuses on these toxicities of interest for patients treated with pacritinib 200 mg twice daily (BID) and best available therapy (BAT), including ruxolitinib, on the phase 3 PERSIST-2 and phase 2 PAC203 studies. Data are presented as risk-adjusted incidences to account for differential time at risk for adverse events (AEs) between arms due to cross-over. Methods: Patients treated with pacritinib 200 mg BID on PERSIST-2 and PAC203, and those treated with BAT, including ruxolitinib on PERSIST-2, were included. Risk-adjusted AEs, representing event rate per 100 patient-years, were calculated for the following: overall and fatal AEs, bleeding AEs (determined by Standardized Medical Dictionary for Regulatory Activities Query [SMQ]), cardiac AEs (by SMQ), major cardiac events (determined by major adverse cardiovascular events [MACE] classification), infections, thromboses, and secondary malignancies. Results: A total of 160 patients were analyzed as the pooled pacritinib 200 mg BID group (n=106 in PERSIST-2; n=54 in PAC203) and 98 patients in the BAT group (44 on ruxolitinib). At baseline, the median platelet count was 57 x 109/L for the pooled pacritinib group and BAT group; hemoglobin was 9.2 vs 9.7 g/dL and 66% vs 53% had prior JAK2 inhibitor therapy respectively. The rate of AEs was higher on pacritinib versus BAT, while the rate of fatal AEs was lower (Table 1). Both bleeding and cardiac events occurred at slightly lower rates on pacritinib compared to BAT. There were no MACE for pacritinib, whereas there were for BAT, including in patients treated with ruxolitinib. Malignant neoplasms (excluding worsening myelofibrosis and leukemia) occurred at similar rates on pacritinib and BAT, though rate of non-melanoma skin cancers was lower in the pooled pacritinib group (3/100 patient-years) versus BAT (7/100 patient-years), including ruxolitinib (11/100 patient-years). Infection occurred more frequently on pacritinib versus BAT, though fungal and viral infections occurred less frequently, as did Herpes Zoster reactivation (pooled pacritinib: 0/100 patient-years vs BAT: 2.4/100 patient-years, including ruxolitinib: 5.5/100 patient-years). Thrombosis occurred at similar rates on pacritinib and BAT. Image:Summary/Conclusion: Risk-adjusted analysis demonstrates that the safety profile of pacritinib 200 mg BID is comparable or superior to BAT, including ruxolitinib. Pacritinib 200 mg BID may represent a full-dose therapeutic option for patients with myelofibrosis, including those with thrombocytopenia.

Direct-to-Implant Versus 2-Stage Breast Reconstruction: Which Technique Is Better? An Analysis of 104 Patients at a Single Institution.

Two-stage (TS) implant-based reconstruction is the most commonly performed method of reconstruction after mastectomy. A growing number of surgeons are offering patients direct-to-implant (DTI) reconstruction, which has the potential to minimize the number of surgeries needed and time to complete reconstruction, as well as improve health care utilization. However, there are conflicting data regarding the outcomes and complications of DTI, and studies comparing the 2 methods exclusively are lacking. Patients undergoing implant-based reconstruction after mastectomy within a large interstate health system between 2015 and 2019 were retrospectively identified and grouped by reconstruction technique (TS and DTI). The primary outcomes were a composite of complications (surgical site occurrences), health care utilization (reoperations, unplanned emergency department visits, and readmissions), and time to reconstruction completion. Risk-adjusted logistic and generalized linear models were used to compare outcomes between TS and DTI. Of 104 patients, 42 underwent DTI (40.4%) and 62 underwent TS (59.6%) reconstruction. Most demographic characteristics, and oncologic and surgical details were comparable between groups ( P > 0.05). However, patients undergoing TS reconstruction were more likely to be publicly insured, have a smoking history, and undergo skin-sparing instead of nipple-sparing mastectomy. The composite outcome of complications, reoperations, and health care utilization was higher for DTI reconstruction within univariate (81.0% vs 59.7%, P = 0.03) and risk-adjusted analyses (odds ratio, 3.78 [95% confidence interval [CI], 1.09-13.9]; P < 0.04). Individual outcome assessment showed increased mastectomy flap necrosis (16.7% vs 1.6%, P < 0.01) and reoperations due to a complication (33.3% vs 16.1%; P = 0.04) in the DTI cohort. Although DTI patients completed their aesthetic revisions sooner than TS patients (median, 256 days vs 479 [ P < 0.01]; predicted mean difference for TS [reference DTI], 298 days [95% CI, 71-525 days]; P < 0.01), the time to complete reconstruction (first to last surgery) did not differ between groups (median days, DTI vs TS, 173 vs 146 [ P = 0.25]; predicted mean difference [reference, DTI], -98 days [95% CI, -222 to 25.14 days]; P = 0.11). In this cohort of patients, DTI reconstruction was associated with higher complications, reoperations, and health care utilization with no difference in time to complete reconstruction compared with TS reconstruction. Further studies are warranted to investigate patient-reported outcomes and cost analysis between TS and DTI reconstruction.

Complete opioid cessation after surgery improves patient-reported pain measures among chronic opioid users

BackgroundPreoperative chronic opioid use is common, but it is unclear whether complete opioid tapering can be achieved postoperatively without adversely affecting pain control and quality of life. This study was designed to assess the association between complete opioid tapering after surgery and patient-reported outcomes for pain intensity and pain interference. MethodsWe identified chronic opioid use patients undergoing a spectrum of nonemergency surgical procedures at a single Veterans Affairs medical institution between December 2017 and 2021. All patients were prospectively followed by a transitional pain service that promoted opioid tapering, assessed opioid use (morphine milligram equivalent), and patient-reported outcomes measurement information system for pain intensity (PROMIS-3a) and pain interference (PROMIS-6b). After stratifying based on whether complete versus partial/no opioid tapering was achieved after surgery, longitudinal changes in patient-reported outcomes and morphine milligram equivalents were compared over time. Independent predictors of complete opioid tapering were assessed using logistic regression models. ResultsIn total, 341 surgical patients (91% male, mean age 64 years) with chronic opioid use underwent surgery during the study period, of which 44 (13%) completely tapered off opioids within 60 days after discharge from the hospital. Patients who completely tapered had significant improvement in the change in patient-reported outcomes for pain intensity and interference with significant differences at 30 and 60 days after discharge for both measures when compared to the partial/no taper group (both P < .05). In risk-adjusted analyses, patients with lower baseline morphine milligram equivalents and those staying longer in the hospital were more likely to achieve complete opioid tapering (both P < .01). ConclusionComplete opioid tapering can be successfully achieved after surgery among patients with chronic opioid use with corresponding improvements in self-reported pain intensity and pain interference. Our results suggest that the highest potential for improving patient-reported outcomes with opioid tapering occurs among patients undergoing orthopedic procedures early after surgical discharge.

Off-Pump Coronary Artery Bypass Graft Surgery with Bilateral Internal Mammary Arteries in Left Main Coronary Artery Disease. Is There Any Benefit in 10-Year Mortality?

Background: The randomized controlled trials comparing coronary artery bypass graft (CABG) surgery versus percutaneous coronary intervention (PCI) included all types of surgical techniques (on-pump and off-pump) and different conduits (arterial and venous). Is it reasonable to assume that all surgical techniques are equal in terms of late mortality? Objectives: The aim of this study was to evaluate whether off-pump CABG surgery using both mammary arteries provides additional benefit over conventional revascularization using single mammary artery in terms of long-term survival for left main coronary artery (LMCA) disease. Methods: We conducted a retrospective, observational and comparative study (n=723) adjusted for risk. A stratified analysis was performed according to the use of single internal thoracic artery (SITA, n=144) or bilateral internal thoracic arteries (BITA, n=579) analyzing survival at 10 years after the intervention. Results: Survival at 10 years was significantly higher in BITA group (79.0%±3.4% vs 67.0%±4.9%, log-rank test, p &lt;0.01). This advantage was also observed in the risk-adjusted analysis (93.0%±4.6 vs 69.0%±5.7 respectively, p=0.03). The use of BITA was an independent predictor of 10-year survival (HR 0.57, 95% CI 0.37-0.87, p=0.01). Conclusion: The use of bilateral internal mammary arteries in patients with left main coronary artery disease undergoing off-pump coronary artery bypass grafting was associated with higher survival at 10 years.

Risk-adjusted safety analysis of pacritinib (PAC) in patients (pts) with myelofibrosis (MF).

7058 Background: PAC is a novel JAK2/IRAK1 inhibitor that has shown significant activity in pts with MF, including those with platelet (plt) counts &lt;50×109/L. Recently, JAK inhibitors have come under increased scrutiny due to specific, emerging toxicities with drugs in this class. This safety analysis focuses on these toxicities of interest for pts treated with PAC 200 mg BID and best available therapy (BAT), including ruxolitinib (RUX), on the Phase 3 PERSIST-2 and Phase 2 PAC203 studies. Data are presented as risk-adjusted incidences to account for differential time at risk for adverse events (AEs) between arms due to cross-over. Methods: Pts treated with PAC 200 mg BID on PERSIST-2 and PAC203, and those treated with BAT on PERSIST-2, were included. Risk-adjusted AEs, representing event rate per 100 patient-years (pt-yrs), were calculated for overall and fatal AEs, bleeding AEs (determined by Standardized Medical Dictionary for Regulatory Activities Query [SMQ]), cardiac AEs (by SMQ), major cardiac events (per major adverse cardiovascular events [MACE] classification), infections, thromboses, and secondary malignancies. Results: A total of 160 pts were analyzed as the pooled PAC group (n=106 in PERSIST-2; n=54 in PAC203) and 98 pts in the BAT group (44 on RUX). At baseline, median plt count was 57×109/L; 61% had prior JAK2 inhibitor therapy. The rate of AEs was higher on PAC versus BAT, while the rate of fatal AEs was lower (Table). Both bleeding and cardiac events occurred at slightly lower rates on PAC compared to BAT. There were no MACE events on PAC, whereas there were on BAT. Malignant neoplasms occurred at similar rates on PAC and BAT, though rate of non-melanoma skin cancers was lower in pooled PAC (3/100 pt-yrs) versus BAT (7/100 pt-yrs), including RUX (11/100 pt-yrs). Infection occurred more frequently on PAC, though fungal and viral infections occurred less frequently, as did herpes zoster reactivation (pooled PAC: 0/100 pt-yrs vs BAT: 2.4/100 pt-yrs, including RUX: 5.5/100 pt-yrs). Thrombosis occurred at similar rates on PAC and BAT. Conclusions: Risk-adjusted analysis demonstrates that the safety profile of PAC 200 mg BID is comparable or superior to BAT, including RUX. PAC 200 mg BID may represent a full-dose therapeutic option for pts with MF, including those with thrombocytopenia. Clinical trial information: NCT02055781; NCT04884191. [Table: see text]

Association Between Intensive Care Unit Admission Practices and Outcomes in Patients with Isolated Traumatic Subarachnoid Hemorrhage: A Nationwide Inpatient Database Analysis in Japan.

Patients with traumatic brain injury associated with intracranial hemorrhage are commonly admitted to the intensive care unit (ICU); however, the need for ICU care for patients with isolated traumatic subarachnoid hemorrhage (tSAH) remains unclear. We aimed to investigate the association between the ICU admission practices and outcomes in patients with isolated tSAH. This observational study used a nationwide administrative database in Japan. We identified patients with isolated tSAH from the Japanese Diagnostic Procedure Combination inpatient database from July 1, 2010, to March 31, 2020. The primary outcome was in-hospital mortality, whereas the secondary outcomes were neurosurgical interventions, activities of daily living at discharge, and total hospitalization cost. We performed a risk-adjusted mixed-effect regression analysis to evaluate the association between hospital-level ICU admission rates and study outcomes. The ICU admission rates were categorized into quartiles: lowest, middle-low, middle-high, and highest. Moreover, we assessed the robustness of the results with a patient-level instrumental variable analysis. Of the 61,883 patients with isolated tSAH treated at 962 hospitals, 16,898 (27.3%) patients were admitted to the ICU on the day of admission. Overall, 2465 (4.0%) patients died in the hospital, and 783 (1.3%) patients underwent neurosurgical interventions. There was no significant difference between the lowest and highest ICU admission quartile in terms of in-hospital mortality (3.7% vs. 4.3%; adjusted odds ratio 0.93; 95% confidence interval [CI] 0.78-1.10), neurosurgical interventions, and activities of daily living at discharge. However, the total hospitalization cost in the lowest ICU admission quartile was significantly lower than that in the highest quartile (US $3032 vs. $4095; adjusted difference US $560; 95% CI 33-1087). The patient-level instrumental variable analysis did not reveal a significant difference in in-hospital mortality between the patients who were admitted to the ICU and those who were not (risk difference 0.2%; 95% CI - 0.1 to 0.5). There was no significant association between the ICU admission practices and outcomes in patients with isolated tSAH, whereas higher ICU admission rates were associated with significantly higher hospitalization costs. Our results provide an opportunity for improved health care allocation in the management of patients with isolated tSAH.

The Road to Technical Proficiency in Cytoreductive Surgery for Peritoneal Carcinomatosis: Risk-Adjusted Cumulative Summation Analysis.

BackgroundCytoreductive surgery (CRS) is a technically demanding procedure, and there is considerable debate about its safe application. This study investigated the learning curve for CRS and the clinical outcomes of consecutive patients treated by a single surgeon at a single institution.MethodsWe collected 251 consecutive patients who underwent CRS for peritoneal metastases by a single surgeon at Fondazione Policlinico Universitario A. Gemelli IRCCS, between January 2016 and December 2020. The learning curve was estimated using the cumulative summation analysis (CUSUM) for operative time (OT). Risk-adjusted CUSUM (RA-CUSUM) charts were developed using a composite variable (surgical failure), defined as the occurrence of at least one of the following events: major postoperative complications (Clavien–Dindo grade ≥3), blood loss ≥500 mL, incomplete cytoreduction. Three learning phases were thus derived from the RA-CUSUM analysis, and were compared in terms of perioperative outcomes.ResultsCUSUM-OT showed that the operation time improved significantly after the 161th case. RA-CUSUM analysis allowed to break the CRS learning curve into three different phases: phase 1, “the learning phase” (cases 1–99), phase 2 “the experienced phase” (cases 100–188), and phase 3, “the mastership phase” (cases 189–251). The rate of major postoperative complications decreased significantly over the three phases (p = 0.019). Operative time decreased significantly as well (p = 0.031) and was significantly shorter in phase 3 with respect to the other two phases (phase 3 vs phase 2: 420 min vs 500 min, p = 0.017; phase 3 vs phase 1: 420 min vs 503 min, p = 0.021). Blood loss consistently decreased throughout the three phases (p = 0.001). The rate of incomplete cytoreduction was significantly lower in phase 3 than in phase 2 (4.8% vs 14.6%, p = 0.043).ConclusionThe CRS failure rate stabilized after the first 99 cases, and the complete surgical proficiency was achieved after 189 cases. A standardised and mentored learning model is a safer strategy to shorten the learning process, to reduce morbidity and mortality, to improve oncologic outcomes.