Propensity Score-adjusted Analysis Research Articles

Two-year outcomes of sleeve gastrectomy versus gastric bypass: first report based on Tehran obesity treatment study (TOTS)

BackgroundBariatric surgery is an effective treatment for obesity and its associated comorbidities. This is the first comprehensive report of a prospective cohort study, comparing sleeve gastrectomy (SG) with gastric bypass (GB) regarding their effectiveness and safety.MethodsThe prospectively collected data of patients, who presented to a specialized bariatric center and underwent a primary bariatric procedure, were compared in terms of weight loss, remission of obesity-associated comorbidities, complication rate, and quality of life improvement at 6-, 12-, and 24-month follow-ups.ResultsOf 3287 patients (78.6% female) analyzed, 67% (n = 2202) and 33% (n = 1085) underwent SG and GB, respectively. Effective outcomes were reported in both groups regarding the body composition indices. Type 2 diabetes mellitus (T2DM) remission rate at the end of follow-up was 53.3% and 63.8% in the SG and GB groups, respectively. Following the propensity score-adjusted analysis, the T2DM remission rate was not significantly different between the groups. Conversely, the remission rate of hypertension in the 24-month follow-up (39.1% vs. 54.7%) and the remission rate of dyslipidemia in all follow-ups were lower in the SG group, compared to the GB group. Moreover, both procedures caused substantial improvements in various domains of quality of life. The surgery duration, early complication rate, and nutritional deficiencies were lower in the SG group, compared to the GB group.ConclusionBoth surgical procedures were effective in the control of obesity and remission of its comorbidities. However, since SG was associated with a lower rate of complications, it seems that SG should be considered as a suitable procedure for obese patients, especially those with a healthier metabolic profile.

A propensity score weighted comparison of Vedolizumab, Adalimumab, and Golimumab in patients with ulcerative colitis

BackgroundNo real-life study on the comparative effectiveness of Vedolizumab (VDZ), Adalimumab (ADA), and Golimumab (GOL) in ulcerative colitis (UC) is currently available. AimsTo compare the effectiveness of the three biologics in consecutive patients with UC. MethodsA three-arms propensity score-adjusted analysis was performed using the Inverse Probability of Treatment Weighting method. Results463 treatments (VDZ: n = 187; ADA: n = 168; GOL: n = 108) were included (median follow-up: 47.6 weeks). At 12 weeks (n = 463), a steroid-free remission was reported in 24.1% patients in the VDZ group, in 33.3% patients in the ADA group, and in 30.6% patients in the GOL group (p = n.s. for all comparisons). At 52 weeks (n = 377), a steroid-free remission was reported in 51.5% patients in the VDZ group, in 31.2% patients in the ADA group, and in 29.4% patients in the GOL group (p = 0.002 for VDZ vs. ADA, p = 0.001 for VDZ vs. GOL, p = n.s. for ADA vs. GOL). Cox survival analysis demonstrated that patients treated with VDZ had reduced probability of treatment discontinuation compared to those treated with ADA (HR: 0.42, 95% CI 0.28–0.64, p < 0.001) and GOL (HR: 0.30, 95% CI 0.19–0.46, p < 0.001), while patients treated with ADA had reduced risk of treatment discontinuation compared to those treated with GOL (HR: 0.71, 95% CI 0.50–1.00, p = 0.048). ConclusionsVDZ was superior to ADA and GOL at 52 weeks and as treatment persistence, while ADA showed a superior treatment persistence compared to GOL.

Thromboembolic and bleeding risk in obese patients with atrial fibrillation according to different anticoagulation strategies

BackgroundData on the relationship between body mass index (BMI), thromboembolic events (TEE) and bleeding in patients with atrial fibrillation (AF) are controversial, and further evidence on the risk of such events in obese patients with AF receiving different anticoagulant therapies (OAC) is needed. Methods and resultsWe divided a total of 9330 participants from the prospective PREFER in AF and PREFER in AF PROLONGATION registries into BMI quartiles at baseline. Outcome measures were TEE and major bleeding complications at the 1-year follow-up. Without OAC, there was a ≥6-fold increase of TEE in the 4th vs other BMI quartiles (P = .019). OAC equalized the rates of TEE across different BMI strata. The occurrence of major bleeding was highest in patients with BMI in the 1st as well as in the 4th BMI quartile [OR 1.69, 95% CI 1.03–2.78, P = .039 and OR 1.86, 95% CI 1.13–3.04, P = .014 vs those in the 3rd quartile, respectively]. At propensity score-adjusted analysis, the incidence of TEE and major bleeding in obese patients receiving non-vitamin K antagonist oral anticoagulants (NOACs) or vitamin K-antagonist anticoagulants (VKAs) was similar (P ≥ .34). ConclusionsOur real-world data suggest no obesity paradox for TEE in patients with AF. Obese patients are at higher risk of TEE, and here OAC dramatically reduces the risk of events. We here found a comparable clinical outcome with NOACs and VKAs in obese patients. Low body weight and obesity were also associated with bleeding, and therefore OAC with the best safety profile should be considered in this setting.

Clinical Outcomes of Patients with Adult T Cell Leukemia-Lymphoma in a Nonendemic Metropolitan Area: A Retrospective Analysis of the Population-Based Osaka Cancer Registry.

Adult T cell leukemia-lymphoma (ATL) is a mature T cell malignancy associated with human T cell leukemia virus type I (HTLV-1), a retrovirus that is endemic in southwestern Japan. Because of population migration, cases of ATL are expected to increase in nonendemic areas. Here, to clarify the outcomes of patients with ATL in the nonendemic metropolitan area of Osaka, we retrospectively analyzed data from the population-based Osaka Cancer Registry from 2010 to 2015. This analysis included 91 patients age ≤70 years who received chemotherapy for ATL. With a median follow-up of 988 days in surviving patients, the probability of 2-year overall survival (OS) was 21.9% (95% confidence interval [CI], 14.1% to 30.9%) and the median OS was 9.8 months (95% CI, 7.3 to 13.5 months). The probability of 2-year OS was 22.2% in the nontransplant group (n=63) and 21.4% in the transplant group (n=28), without a statistically significant difference between the 2 groups. Allogeneic transplantation was not a favorable prognostic factor in patients with ATL in propensity score-adjusted analysis (P=.86, log-rank test). More clinical studies are needed to improve the clinical outcomes of patients with ATL in nonendemic areas.

Stereotactic Cavity Irradiation or Whole-Brain Radiotherapy Following Brain Metastases Resection-Outcome, Prognostic Factors, and Recurrence Patterns.

Introduction: Following the resection of brain metastases (BM), whole-brain radiotherapy (WBRT) is a long-established standard of care. Its position was recently challenged by the less toxic single-session radiosurgery (SRS) or fractionated stereotactic radiotherapy (FSRT) of the resection cavity, reducing dose exposure of the healthy brain.Patients and Methods: We analyzed 101 patients treated with either SRS/FSRT (n = 50) or WBRT (n = 51) following BM resection over a 5-year period. Propensity score adjustment was done for age, total number of BM, timepoint of BM diagnosis, controlled primary and extracranial metastases. A Cox Proportional Hazards model with univariate and multivariate analysis was fitted for overall survival (OS), local control (LC) and distant brain control (DBC).Results: Median patient age was 61 (interquartile range, IQR: 56–67) years and the most common histology was non-small cell lung cancer, followed by breast cancer. 38% of the patients had additional unresected BM. Twenty-four patients received SRS, 26 patients received FSRT and 51 patients received WBRT. Median OS in the SRS/FSRT subgroup was not reached (IQR NA−16.7 months) vs. 12.6 months (IQR 21.3–4.4) in the WBRT subgroup (hazard ratio, HR 3.3, 95%-CI: [1.5; 7.2] p < 0.002). Twelve-months LC-probability was 94.9% (95%-CI: [88.3; 100.0]) in the SRS subgroup vs. 81.7% (95%-CI: [66.6; 100.0]) in the WBRT subgroup (HR 0.2, 95%-CI: [0.01; 0.9] p = 0.037). Twelve-months DBC-probabilities were 65.0% (95%-CI: [50.8; 83.0]) and 58.8% (95%-CI: [42.9; 80.7]), respectively (HR 1.4, 95%-CI: [0.7; 2.7] p = 0.401). In propensity score-adjusted multivariate analysis, incomplete resection negatively impacted OS (HR 3.9, 95%-CI: [2.0;7.4], p < 0.001) and LC (HR 5.4, 95%-CI: [1.3; 21.9], p = 0.018). Excellent clinical performance (HR 0.4, 95%-CI: [0.2; 0.9], p = 0.030) and better graded prognostic assessment (GPA) score (HR 0.4, 95%-CI: [0.2; 1.0], p = 0.040) were prognostic of superior OS. A higher number of BM was associated with a greater risk of developing new distant BM (HR 5.6, 95%-CI: [1.0; 30.4], p = 0.048). In subgroup analysis, larger cavity volume (HR 1.1, 95%-CI: [1.0; 1.3], p = 0.033) and incomplete resection (HR 12.0, 95%-CI: [1.2; 118.3], p = 0.033) were associated with inferior LC following SRS/FSRT.Conclusion: This is the first propensity score-adjusted direct comparison of SRS/FSRT and WBRT following the resection of BM. Patients receiving SRS/FSRT showed longer OS and LC compared to WBRT. Future analyses will address the optimal choice of safety margin, dose and fractionation for postoperative stereotactic RT of the resection cavity.

Early Versus Late Rib Fixation in Patients With Traumatic Rib Fractures: A Nationwide Study

The appropriate timing of rib fixation remains unclear. We investigated the efficacy of earlyrib fixation compared with late rib fixation, using data from a Japanese nationwide inpatient database. We identified patients who underwent rib fixation and received mechanical ventilation from July 1, 2010, to March 31, 2018, using data from the Diagnosis Procedure Combination database in Japan. The primary outcome was the duration of mechanical ventilation after rib fixation. Secondary outcomes were the length of hospital stay after rib fixation, total hospitalization costs, tracheostomy, pneumonia after admission, and all-cause 28-day in-hospital mortality. We performed propensity score-adjusted analyses to compare outcomes between patients undergoing rib fixation less than or equal to 6 days after admission and those undergoing rib fixation greater than 6 days after admission. We identified 211 patients, including 113 patients undergoing early rib fixation and 98 patients undergoing late rib fixation. In the propensity score-adjusted analyses, early rib fixation was associated with shorter duration of mechanical ventilation (difference, -26.7%; 95% confidence interval [CI], -39.4% to -11.4%), shorter length of hospital stay (difference, -33.3%; 95% CI, -52.8% to -5.6%), and lower total hospitalization costs (difference, -28.7%; 95% CI, -38.4% to -17.5%). There were no significant differences between the groups regarding the proportions of patients receiving tracheostomy (odds ratio [OR], 0.67; 95% CI, 0.31-1.48), pneumonia after admission (OR, 0.74, 95% CI, 0.33-1.65), or all-cause 28-day in-hospital mortality (OR, 0.90, 95% CI, 0.06-12.5). Early rib fixation was associated with better in-hospital outcomes.

Is tacking the lax transversalis fascia an easy, safe and effective way to reduce the occurrence of seroma after laparoscopic inguinal hernioplasty? A propensity score-matched and -adjusted analysis.

Post-operative seroma formation rate is higher in laparoscopic hernioplasty as compared with open repair. Tacking of lax transversalis fascia of direct inguinal hernia is one of the many methods described to reduce the incidence of seroma after laparoscopic inguinal hernioplasty. Our objective is to investigate whether this technique is simple and reliable in reducing the incidence of seroma. A retrospective analysis of 548 patients who underwent laparoscopic inguinal hernioplasty between January 2011 and December 2017 was conducted. Patients demographics, operative data and post-operative complications were collected. 38 patients with transversalis fascia tacking were matched using one-to-one propensity score matching with another 38 patients without transversalis fascia tacking. Propensity score-matched analysis and propensity score-adjusted analysis were performed. Patients who underwent transversalis fascia tacking (tacking group) had a significant lower incidence of post-operative seroma, compared to the non-tacking group tacking vs non-tacking: 5.6% vs 28.6% (p = 0.0097) in propensity-score matched analysis and 5.6% vs 21.3% (p = 0.0153) in propensity-score adjusted analysis. There was no difference noted in the duration of the operation and post-operative complications, in particular post-operative pain. Tacking of lax transversalis facia to the symphysis pubis and Cooper's ligament is a simple yet safe and effective way to reduce the occurrence of seroma after laparoscopic inguinal hernioplasty.

Postoperative Anaemia Is a Risk Factor for Bleeding-Related Event in Thromboprophylaxis Using Fondaparinux Sodium Injection after Total Knee or Hip Arthroplasty.

Bleeding is a life-threating side effect of thromboprophylaxis with fondaparinux sodium (FPX) injection. The purpose of this retrospective study was to assess the risk factor for bleeding-related event following thromboprophylaxis with FPX after total knee arthroplasty (TKA) or total hip arthroplasty (THA). Adult patients undergoing TKA or THA at a single university hospital were administered FPX for thromboprophylaxis by subcutaneous injection of 1.5 or 2.5 mg per day. The risk factor for bleeding-related event was identified by propensity score-adjusted multivariate logistic analysis, and survival analysis was performed retrospectively in consideration of the identified risk factors. Two hundred and twenty-six patients who underwent TKA (n = 62) or THA (n = 164) were enrolled. Anaemia on postoperative day (POD) 1 was identified as a risk factor for bleeding-related event (odds ratio: 3.75, 95% confidence interval: 1.02-24.5, p = 0.04). Eighty of 226 patients were selected using a propensity score matching and patients with anaemia on POD1 in this population had a significantly higher incidence of bleeding-related event than those without anaemia (p = 0.0016, Ghen-Breslow-Wilcoxon test; p = 0.0015, log-rank test). These results suggest that anaemia on POD1 is an independent risk factor for bleeding-related event following thromboprophylaxis with FPX after TKA or THA.

Efficacy of second-line chemotherapy after standard combination chemotherapy in patients with metastatic pancreatic cancer: The results from the NAPOLEON study.

661 Background: Gemcitabine plus nab-paclitaxel (GnP) and FOLFIRINOX (FFX) have been established as standard first-line combination chemotherapy (CTx) for patients with metastatic pancreatic cancer (MPC). However, the efficacy of second-line CTx and the significance of combination CTx in clinical practice are unclear. We therefore investigated the efficacy of second-line CTx in patients with MPC. Methods: Data were collected from CTx-naive MPC patients treated with first-line combination CTx at 14 hospitals in the Kyushu area of Japan from December 2013 to June 2018. The median overall survival (mOS) from second-line treatment was compared between patients who received second-line CTx (CT group) and those who received best supportive care (BSC group). Furthermore, in the CT group, the mOS was compared between the patients who received combination CTx and those who received mono-CTx. To control potential bias in the selection of second-line treatment, we also conducted a propensity score-adjusted analysis. Results: A total of 255 patients received GnP or FFX as first-line CTx. Of these, there were 156 (61%) in the CT group and 77 (30%) in the BSC group. The number of patients who received FFX/GnP as first-line CTx was 79 (51%)/77 (49%) in the CT group and 15 (20%)/62 (80%) in the BSC group, respectively (P &lt; 0.01). The mOS in the CT group was significantly longer than that in the BSC group (5.2 vs. 2.7 months; hazard ratio [HR] 0.42; 95% confidence interval [CI] 0.31-0.57; p &lt; 0.01 and 5.2 vs. 2.6 months; adjusted HR 0.39; 95% CI 0.28-0.55; p &lt; 0.01). In the CT group, 89 (57%) patients received combination CTx, and 67 (43%) received mono-CTx. There was no significant difference in the mOS between the combination CTx and mono-CTx patients (5.5 vs. 4.4 months; HR 0.88; 95% CI 0.62-1.26; p = 0.88 and 5.6 vs. 4.4 months; adjusted HR 0.85; 95% CI 0.56-1.30; p = 0.47). Conclusions: Among patients with MPC receiving second-line treatment, the CT group had a significantly longer mOS than the BSC group, but combination CTx conferred no improvement in the survival duration compared with mono-CTx.

Long-Term Follow-Up of Transcatheter Aortic Valve Implantation With Portico Versus Evolut Devices

New-generation devices such as Evolut and Portico have provided favorable results in patients who underwent transcatheter aortic valve implantation (TAVI) for aortic stenosis, but their comparative effectiveness remains debated, despite its relevance when envisioning TAVI in low-risk patients. We evaluated the safety and efficacy of 2 leading TAVI devices (Evolut and Portico) used by the same team of experienced TAVI operators, focusing on long-term outcomes, including major adverse events (i.e., the composite of death, stroke, myocardial infarction, major vascular complication, or major bleeding). Unadjusted and propensity score-adjusted analyses were carried out. A total of 233 patients were included, 119 (51.1%) receiving Evolut and 114 (49%) Portico. Baseline and procedural data showed significant between-device differences, including functional class, surgical risk, chronic obstructive pulmonary disease, renal function, transesophageal guidance, device size, postdilation, and procedural time (all p <0.05). Yet, acute and in-hospital outcomes were not significantly different (all p >0.05). Follow-up status was ascertained in 228 (98%) patients after 15.0 ± 7.6 months. Unadjusted analysis showed similar rates of major adverse events, as well as the individual risk of death, stroke, myocardial infarction, major vascular complication, major bleeding, and pacemaker implantation (all p >0.05). Even at propensity score-adjusted analysis outcomes were not significantly different with Evolut and Portico (all p >0.05). In conclusion, Evolut and Portico devices yield similarly favorable results at long-term follow-up when used by experienced TAVI operators.

P325 A propensity score-weighted comparison of vedolizumab and adalimumab in Crohn’s disease: Real-life data from the Sicilian Network for inflammatory bowel disease (SN-IBD)

Abstract Background Currently, there are no randomised controlled trials focussing on direct comparisons between biologics in Crohn’s disease (CD), while there is an unmet need to better understand and compare the effectiveness of these drugs. We performed a multicentre, real-life, comparison of the effectiveness of vedolizumab (VDZ) and adalimumab (ADA) in CD. Methods Data of consecutive patients with CD treated with VDZ and ADA from January 2016 to April 2019 were extracted from the cohort of the Sicilian Network for Inflammatory Bowel Disease (SN-IBD). A propensity score analysis was performed using the Inverse Probability of Treatment Weighting (IPTW) method. The effectiveness was evaluated at 12 weeks, 52 weeks, and as treatment persistence at the end of follow-up. The clinical endpoints were steroid-free clinical remission (Harvey–Bradshaw Index &amp;lt; 5 without steroid use) and clinical response (reduction of the Harvey–Bradshaw Index ≥ 3 points with a concomitant decrease of steroid dosage compared with baseline). The sum of the two outcomes was defined as a clinical benefit. The achievement of endoscopic response (a reduction of Simple Endoscopic Score for CD ≥ 50% compared with baseline) or mucosal healing (Simple Endoscopic Score for CD ≤ 2) was assessed after at least 6 months of treatment. Results A total of 585 treatments (VDZ: n = 277; ADA: n = 308) were included, with a median follow-up of 56.0 weeks (IQR 24.0–104.0). After 12 weeks, a clinical benefit was achieved in 64.3% patients treated with VDZ and in 83.1% patients treated with ADA (p = 0.11 in propensity score analysis), while at 52 weeks a clinical benefit was observed in 54.0% patients treated with VDZ and in 69.1% patients treated with ADA (p = 0.33 in propensity score analysis). The median treatment persistences for VDZ and ADA were 52 weeks and 64 weeks, respectively. Cox survival analysis weighted for IPTW showed no significant difference in the probability of treatment discontinuation between the two drugs (HR for VDZ=1.20; p = 0.34). Post-treatment endoscopic response and mucosal healing rates were similar between the two drugs (endoscopic response: 35.3% for VDZ and 25.5% for ADA, p = 0.15; mucosal healing: 31.8% for VDZ and 33.8% for ADA, p = 0.85). Conclusion This is the first real-life study comparing VDZ and ADA in CD patients via propensity score-adjusted analysis. Even if crude rates of all clinical outcomes were higher for ADA compared with VDZ, such differences were not significant when patients’ characteristics at baseline were weighted by propensity score.

P690 A propensity score weighted comparison of vedolizumab, adalimumab, and golimumab in patients with ulcerative colitis: Real-life data from the Sicilian Network for Inflammatory Bowel Disease (SN-IBD)

Abstract Background No real-life study aiming at comparing at the same time the effectiveness of vedolizumab (VDZ), adalimumab (ADA), and golimumab (GOL) in Ulcerative colitis (UC) is currently available. Methods Data of consecutive patients with UC treated with VDZ, ADA, and GOL from June 2015 to December 2018 were extracted from the cohort of the Sicilian Network for Inflammatory Bowel Disease (SN-IBD). A three-arms propensity score-adjusted analysis was performed to reduce bias caused by imbalanced covariates at baseline, including the proportion of TNF-α inhibitor naïve and non-naïve patients, using the Inverse Probability of Treatment Weighting (IPTW) method. The effectiveness was evaluated at 8 weeks, 52 weeks, and as treatment persistence at the end of follow-up. The clinical endpoints were steroid-free clinical remission (partial Mayo score &amp;lt;2 without steroid use) and clinical response (reduction of the partial Mayo score ≥2 points with a concomitant decrease of steroid dosage compared with baseline). The sum of the two outcomes was defined as a clinical benefit. The achievement of mucosal healing (endoscopic Mayo score 0–1) was assessed after at least 6 months of biological treatment. Results A total of 463 treatments (VDZ: n = 187; ADA: n = 168; GOL: n = 108) were included, with a median follow-up of 47.6 weeks (IQR 20.0–85.9). At 8 weeks, a clinical benefit was achieved in 70.6% patients treated with VDZ, in 68.5% patients treated with ADA, and in 67.6% patients treated with GOL (p = n.s. for all comparisons). After 52 weeks, VDZ showed better rates of clinical benefit compared with both ADA (71.6% vs. 47.5; OR: 2.79, 95% CI 1.63–4.79, p &amp;lt; 0.001) and GOL (71.6% vs. 40.2%; OR: 3.77, 95% CI 2.08–6.80, p &amp;lt; 0.001), while the difference between ADA and GOL was not significant. Cox survival analysis demonstrated that patients treated with VDZ had a reduced probability of treatment discontinuation compared with those treated with ADA (HR: 0.42, 95% CI 0.28–0.64, p &amp;lt; 0.001) and GOL (HR: 0.30, 95% CI 0.19–0.46, p &amp;lt; 0.001), while patients treated with ADA had a reduced risk of treatment discontinuation compared with those treated with GOL (HR: 0.71, 95% CI 0.50–1.00, p = 0.048). Post-treatment mucosal healing rates showed a numerical but non-significant difference in favour of VDZ (48.1%) compared with ADA and GOL (38.0% and 34.6%, respectively). Conclusion In the first study comparing at the same time the clinical effectiveness of VDZ, ADA, and GOL in UC patients via propensity score-adjusted analysis, VDZ was superior to both subcutaneous agents at 52 weeks and as treatment persistence, while ADA showed a superior treatment persistence compared with GOL.

Survival Advantage With Adjuvant Chemotherapy for Locoregionally Advanced Rectal Cancer: A Veterans Health Administration Analysis.

Adjuvant chemotherapy (AC) after chemoradiation (CRT) and surgery for locoregionally advanced rectal cancer (LARC) is a standard of care in the United States. This study examined the role, optimal regimen, and duration of AC using data from the largest integrated health system in the United States. Using the Veterans Affairs Central Cancer Registry, patients with stage II-III rectal cancer diagnosed in 2001 through 2011 who received neoadjuvant CRT and surgery with or without AC were identified. Kaplan-Meier analysis, log-rank tests, and propensity score (PS) adjustment analysis were used to assess survival. A total of 866 patients were identified; 417 received AC and 449 did not (observation [OBS] group). Median follow-up was 109 months. Median disease-specific survival (DSS) was not reached. Six-year DSS was 73.7%; 79.5% for the AC group versus 68.0% for the OBS group. PS-matched analysis for DSS favored AC (P=.0002). Median overall survival (OS) was 90.8 months. Six-year OS was 56.7%; 64.3% for AC versus 49.6% for OBS. In PS-matched analysis, median OS was 117.4 months for AC and 74.3 months for OBS (P<.0001). A DSS advantage was seen when comparing ≥4 months with <4 months of AC (P=.023). No difference in DSS or OS was seen with single-agent versus multiagent AC. In this population of patients with LARC treated with neoadjuvant CRT and surgery, OS and DSS were improved among those treated with AC versus OBS. DSS benefits were seen with ≥4 months of AC. No additional benefit was observed with multiagent therapy. In the absence of phase III data, these findings support the use of AC for LARC.

Incidence, prognosis, and risk factors for bladder and bowel dysfunction due to incidental dural tears in lumbar microendoscopic surgery

BACKGROUND CONTEXTDespite the common occurrence of incidental dural tears, the incidence and prognosis of bladder and bowel dysfunction (BBD) due to incidental dural tears in lumbar spinal surgery are not well known because of the lack of reported cases. PURPOSETo analyze the incidence, prognosis, and risk factors for BBD after lumbar microendoscopic surgery with or without incidental dural tears. STUDY DESIGN/SETTINGA retrospective cohort study. PATIENT SAMPLEWe analyzed 2,421 patients who underwent lumbar microendoscopic surgery and investigated patients with BBD after an incidental durotomy during surgery. OUTCOME MEASURESPatients were divided into three groups on the basis of dysuria and defecation disorders: severe BBD, mild BBD, and no BBD. The post void residual volumes before and after surgery were compared using an ultrasound bladder scanner or bladder catheterization after confirmation of urination. Bowel dysfunction was evaluated by subjective symptomatic deterioration and the increase in the frequency and duration of postoperative medical care. METHODSRisk factors for BBD were analyzed using surgical video documentation to determine the dural tear site and cauda equina exposure from the dural sac. Patients with BBD were prospectively followed up for prognosis determination. The chi-square test was used to compare the incidence of BBD between patients with dural tears and those without. Propensity score-adjusted logistic regression analysis was performed to evaluate the effects of various factors on the incidence of postoperative BBD. RESULTSThe incidence of dural tears was 6.9% (168/2,421). The overall incidence of BBD was 3.0% (73/2,421), while the incidences of BBD (mild+severe BBD) and severe BBD due to incidental dural tears were 1.2% (30/2,421) and 0.8% (20/2,421), respectively. The incidence of BBD in patients with dural tears and those without tears was 17.9% [30/168] and 1.9% [43/2,253; p<.001]), respectively. BBD rates at 1 week, 1 month, 3 months, 6 months, and 1 year after surgery were 64.0%, 44.0%, 40.0%, 28.0%, and 13.6%, respectively. Logistic regression analysis revealed that the male sex (odds ratio [OR], 4.20), dural tears in the central area (OR, 10.15), and exposure of the cauda equina (OR, 51.04) were significant risk factors. CONCLUSIONSThe incidence of dural tears in lumbar microendoscopic surgeries are associated with an increased incidence of BBD. The recovery rate for BBD due to incidental dural tears is generally good; however, some patients experience long-term symptoms. Clinicians should be aware that incidental dural tears with cauda equina exposure can increase the risk of BBD.

Comparison between IMP carbapenemase-producing Enterobacteriaceae and non-carbapenemase-producing Enterobacteriaceae: a multicentre prospective study of the clinical and molecular epidemiology of carbapenem-resistant Enterobacteriaceae.

Carbapenem-resistant Enterobacteriaceae (CRE) are classified as carbapenemase-producing Enterobacteriaceae (CPE) and non-CPE; the majority of CPE in Japan produce IMP carbapenemase. We evaluated the clinico-epidemiological and microbiological information and effects of IMP-type carbapenemase production in CRE. Patients with isolations of CRE (MICs of meropenem ≥2 mg/L, imipenem ≥2 mg/L or cefmetazole ≥64 mg/L) from August 2016 to March 2018 were included. Microbiological analyses and WGS were conducted and clinical parameters were compared between groups. Independent predictors for the isolation of CPE from patients were identified by logistic regression. For comparing clinical outcomes, a stabilized inverse probability weighting method was used to conduct propensity score-adjusted analysis. Ninety isolates (27 CPE and 63 non-CPE) were collected from 88 patients (25 CPE and 63 non-CPE). All CPE tested positive for IMP carbapenemase. Antibiotic resistance (and the presence of resistance genes) was more frequent in the CPE group than in the non-CPE group. Independent predictors for CPE isolation were residence in a nursing home or long-term care facility, longer prior length of hospital stay (LOS), use of a urinary catheter and/or nasogastric tube, dependent functional status and exposure to carbapenem. Although in-hospital and 30 day mortality rates were similar between the two groups, LOS after CRE isolation was longer in the CPE group. IMP-CPE were associated with prolonged hospital stays and had different clinical and microbiological characteristics compared with non-CPE. Tailored approaches are necessary for the investigational and public health reporting, and clinical and infection prevention perspectives for IMP-CPE and non-CPE.

Acute normovolemic hemodilution reduced allogeneic blood transfusion without increasing perioperative complications in patients undergoing free-flap reconstruction of the head and neck.

PurposeThe present case–control study was conducted to evaluate whether acute normovolemic hemodilution (ANH) can reduce the need for perioperative allogeneic blood transfusion (ABT) and affect the incidence of perioperative complications in free-flap reconstruction of the head and neck.MethodsThis single-center, retrospective, observational study included the perioperative data of 123 patients who underwent free-flap reconstruction of the head and neck following oncological surgery. Patients were divided into the following two groups according to whether they received ANH: ANH group and non-ANH group. We investigated whether ANH can reduce the need for perioperative ABT using propensity score-adjusted logistic regression analysis.ResultsOf the 123 patients, 113 patients were assessed; 57 patients were in the ANH group and 56 patients were in the non-ANH group. The rate [ANH group vs. non-ANH group, n (%): 2 (3.5%) vs. 23 (41.1%), p < 0.0001] and amount [median (IQR): 0 mL (0, 0) vs. 0 mL (0, 280), p < 0.0001] of ABT were significantly lower in the ANH group than in the non-ANH group. Propensity score-adjusted multivariate logistic regression analysis indicated that ANH use [odds ratio (OR): 0.040; 95% confidence interval (CI) 0.005, 0.320; p = 0.0024)] was one of the independent predictors of perioperative ABT. There were no significant differences in the incidences of post-operative complications between the two groups.ConclusionANH use can reduce the need for perioperative ABT in patients undergoing free-flap reconstruction of the head and neck without increasing the incidence of post-operative complications.

Comparative one-month safety and effectiveness of five leading new-generation devices for transcatheter aortic valve implantation

Transcatheter aortic valve implantation (TAVI) for aortic stenosis is becoming an appealing alternative to surgical aortic valve replacement in high-risk patients and to medical therapy for inoperable ones. Several new-generation TAVI devices have been recently introduced, but comparative analyses are lacking. We aimed to compare 1-month outcomes associated with such five leading new-generation TAVI devices exploiting data collected in the prospective observational RISPEVA (Registro Italiano GISE sull’impianto di Valvola Aortica Percutanea) Study. We queried the dataset of the ongoing RISPEVA study to retrieve baseline, procedural and 1-month outcome details of patients undergoing TAVI with Acurate, Evolut, Portico, Lotus, and Sapien3. Analysis was based on unadjusted and propensity score-adjusted methods. We included 1976 patients, 234 (11.8%) treated with Acurate, 703 (35.6%) with Evolut, 151 (7.6%) with Lotus, 347 (17.6%) with Portico, and 541 (27.4%) with Sapien3. Unadjusted analysis for baseline features highlighted several significant differences, and other discrepancies were found for procedural features. Despite these differences, device and procedural success were similarly high (ranging from 98.0% to 99.4%, p > 0.05). However, procedural valve migration appeared more common with Acurate (p = 0.007), and major bleeding with Sapien3 (p = 0.002). Unadjusted analysis for 1-month outcomes also highlighted significant differences in the composite of death, stroke, myocardial infarction, major vascular complication, major bleeding, or renal failure (favoring Portico, p < 0.001), major vascular complications (favoring Lotus, p < 0.001), renal failure (favoring Portico, p = 0.035), and permanent pacemaker implantation (favoring Acurate, p < 0.001). Propensity score-adjusted analyses showed lower rates of major adverse events with Evolut and Portico (p < 0.05), major vascular complications with Lotus and Portico (p < 0.05), renal failure with Sapien3 (p < 0.05) and permanent pacemaker implantation with Acurate (p < 0.05). In conclusion, new-generation TAVI devices have different profiles of early comparative safety and efficacy. These findings should be taken into account for individualized decision making and patient management.

Utility of autologous fibrin glue and polyglycolic acid sheet for preventing delayed bleeding associated with antithrombotic therapy after gastric ESD.

Background and study aims Delayed bleeding is one of the most serious adverse events of gastric endoscopic submucosal dissection (ESD), especially in patients taking antithrombotic therapy. This study aimed to evaluate the utility and safety of a shielding method with autologous fibrin glue and polyglycolic acid (PGA) sheets for patients undergoing gastric ESD who are receiving antithrombotic therapy. Patients and methods One hundred twenty-three patients who were treated with gastric ESD while receiving antithrombotic therapy between December 2014 and September 2017 were enrolled in this study. Patients who received the shielding method were classified into the shielding group. Others were classified into the conventional group. Various clinico-pathological factors were retrospectively compared between the two groups. Results The shielding group consisted of 38 patients, and the conventional group consisted of the remaining 85 patients. In the shielding group, the rate of continuation of antithrombotic therapy was significantly higher (68.4 % vs 41.2 %). Incidence of delayed bleeding was lower in the shielding group (2.6 %, 1/38) than in the conventional group (14.1 %, 12/85). In the propensity score-adjusted logistic regression analysis, the delayed bleeding rate in the shielding group tended to be lower than in the conventional group ( P = 0.070). Allogeneic transfusion was performed in eight patients (8/85, 9.4 %) in the conventional group and none in the shielding group ( P = 0.047). No adverse event associated with endoscopic shielding were observed in the shielding group. Conclusions This study suggests that a shielding method with autologous fibrin glue and PGA sheet effectively prevents delayed bleeding after gastric ESD in patients receiving antithrombotic therapy.

Outcomes With Complete Versus Incomplete Revascularization in Patients With Multivessel Coronary Disease Undergoing Percutaneous Coronary Intervention With Everolimus Eluting Stents

The aim of the study was to evaluate the outcomes with completeness of revascularization (CR) in patients with multivessel disease (MVD) who underwent PCI using everolimus-eluting stent (EES). Patients with MVD who underwent PCI using EES in New York State were chosen. Patients were categorized into CR, attempted but failed CR or incomplete revascularization (ICR). The primary outcome was death/myocardial infarction (MI). Secondary outcomes were death/MI/repeat revascularization and the individual components of the composite outcomes. Multiple propensity score adjustment analysis was used to adjust for differences in covariates among the 3 groups. Among 15,046 patients, 4,545 (30%) had CR. The strongest predictors of ICR were the number of vessels diseased (χ2 = 428.48; p <0.0001) and presence of chronic total occlusion (CTO) (χ2 = 184.27; p <0.0001). In the multiple propensity score-adjusted analysis, over a mean follow-up of 2.9 years, compared with CR, ICR was associated with significant higher risk of death/MI (17.49% vs 12.69%; hazard ratio [HR] = 1.15; 95% confidence interval [CI] 1.02 to 1.29; p = 0.02), death/MI/repeat revascularization (48.01% vs 37.85%; HR = 1.19; 95% CI 1.12 to 1.27; p <0.0001), death (12.41% vs 8.63%; HR = 1.16; 95% CI 1.00 to 1.35; p = 0.047), and repeat revascularization (39.16% vs 31.63%; HR = 1.20; 95% CI 1.12 to 1.28; p <0.0001), with numerically higher rates of MI (7.18% vs 4.90%; HR = 1.17; 95% CI 0.98 to 1.40; p = 0.09). The risk with attempted but failed CR was intermediate between CR and ICR. In conclusion, in patients with MVD who underwent PCI with EES, incomplete revascularization is associated with significantly higher risk of cardiovascular events including death compared with complete revascularization.

Is There a Role for Surgery in Patients with Neuroendocrine Tumors of the Esophagus? A Contemporary View from the NCDB.

Esophageal neuroendocrine tumors (eNETs) are exceedingly rare, aggressive and have a poor prognosis. Treatment guidelines are ill-defined and mainly based on evidence from case reports and analogous experiences drawn from similar disease sites. The NCDB was reviewed for histologically confirmed stage I-III, primary eNETs from 2006 to 2014. Patients were grouped into whether or not they underwent primary tumor resection. Univariate, multivariable, and full bipartite propensity score (PS) adjusted Cox regression analyses were used to assess overall and relative survival differences. A total of 250 patients were identified. Mean age was 65.0 (standard deviation [SD] 11.9) years, and 174 (69.6%) patients were male. Most patients had stage III disease (n = 136, 54.4%), and the most common type of NET was small cell eNET (n = 111, 44.4%). Chemotherapy was used in 186 (74.4%), radiation therapy in 178 (71.2%), and oncological resection was performed in 69 (27.6%) patients. Crude 2-year survival rates were higher in the operated (57.3%) compared with the nonoperated group (35.2%; p < 0.001). The survival benefit held true after multivariable adjustment (hazard ratio [HR] 0.47, 95% confidence interval [CI] 0.32-0.69, p < 0.001). After full bipartite PS adjustment analysis, survival was longer for patients who received a surgical resection compared with those who did not (HR 0.48, 95% CI 0.31-0.75, p = 0.003) with a corresponding 2-year overall survival rate of 63.3% (95% CI 52.0-77.2) versus 38.8% (95% CI 30.9-48.8), respectively. Multimodal treatment that includes surgery is associated with better overall survival for eNETs. Additional research is needed to more definitively identify patients who benefit from esophagectomy and to establish an appropriate treatment algorithm.