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Background: Although endovascular aneurysm repair (EVAR) for abdominal aortic aneurysm (AAA) is widely used worldwide, the fact that it is associated with increased rates of reintervention has been considered a problem. This study aimed to analyze the outcomes of primary open AAA repair and open conversion with explantation of stent grafts after EVAR., Methods: In this retrospective study, we enrolled 1,120 patients (open repair, n = 664; EVAR, n = 456) who underwent AAA repair at Kobe University from 1999 to 2019. Of the 664 patients who underwent open repair, 121 (patients who underwent primary open repair (POR) as a concomitant procedure and patients with ruptured AAA) were excluded from the study. The outcomes of POR were compared with those of open conversion with explantation of stent grafts., Results: Of the 543 patients who underwent open repair, 513 underwent POR and 30 underwent open conversion with explantation of stent grafts. The operation time for POR was significantly less than that for open conversion with explantation. During surgery, patients who underwent open conversion with explantation required significantly more transfusions of red cell concentrate, fresh frozen plasma, and platelet concentrate than those who underwent POR. Overall, 30 patients who underwent open conversion with explantation required a total of 48 reinterventions before surgery. Hospital mortality rates were 0.7% and 0% in the POR and open conversion with explantation groups, respectively (P = 0.62). Although overall survival at 5 years in the POR group was significantly better than that in the open conversion with explantation group (89.3 ± 1.7% vs. 79.5 ± 9.6%; P = 0.01), there were no significant differences between the 2 groups regarding the freedom from aortic event (hospital death, reintervention, and aortic death). According to the multivariate analysis, open conversion with explantation was not an independent risk factor for late death. There were 20 patients who were hesitant to undergo OCE, although we recommended OCE. In a subgroup analysis, the overall mean cost borne by patients who underwent EVAR was approximately 2.3 times higher compared with that borne by patients who underwent POR., Conclusions: Although demanding, both early and long-term outcomes of OCE have been favorable in our present study. OCE is highly recommended in patients with persistent sac enlargement after EVAR., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Background: Hemodialysis patients who undergo surgery have a high risk of postoperative complications. The aim of this study was to determine whether colon cancer surgery can be safely performed in hemodialysis patients., Methods: This multicenter retrospective study included 1372 patients who underwent elective curative resection surgery for colon cancer between April 2016 and March 2020., Results: Of the total patients, 19 (1.4%) underwent hemodialysis, of whom 19 (100%) had poor performance status and 18 had comorbidities (94.7%). Minimally invasive surgery was performed in 78.9% of hemodialysis patients. The postoperative complication rate was significantly higher in hemodialysis than non-hemodialysis patients (36.8% vs. 15.5%, p = 0.009). All postoperative complications in the hemodialysis patients were infectious type. Multivariate analysis revealed a significant association of hemodialysis with complications (odds ratio, 2.9362; 95%CI, 1.1384-7.5730; p = 0.026)., Conclusion: Despite recent advances in perioperative management and minimally invasive surgery, it is necessary to be aware that short-term complications can still occur, especially infectious complications in hemodialysis patients., Competing Interests: The authors have declared that no competing interests exist.

Background: Consensus regarding an optimal atrial fibrillation (AF) ablation lesion set concomitant with aortic valve replacement (AVR) and/or coronary artery bypass grafting (CABG) has not been established., Methods: We enrolled 125 consecutive patients (89 men; 70 ± 8 years old) with persistent AF who underwent radiofrequency-based pulmonary vein isolation (PVI) (PVI group, n = 53) or a Cox-Maze procedure (Maze group, n = 72) with AVR and/or CABG. To reduce the impact of treatment bias and potential confounding in the direct comparisons between patients who underwent Cox-Maze with and those who underwent PVI, we established weighted Cox proportional-hazards regression models with inverse probability of treatment weighting. Mean follow-up was 63 ± 34 months (maximum, 154 months)., Results: There was 1 in-hospital death in each group. Patients who underwent Cox-Maze showed a higher freedom from AF at all follow-up examinations. After the operation, there were 32 deaths, 13 thromboembolisms, 8 hemorrhagic events, and 22 heart failure readmissions. The Maze group had higher rates for 5-year survival (88% vs 64%, P = .013) and freedom from composite events (74% vs 42%, P < .001). After adjustment with inverse probability of treatment weighting, the Cox-Maze procedure still showed a lower risk of overall mortality (adjusted hazard ratio, 0.38; 95% confidence interval, 0.21-0.66; P = .001) and composite adverse events (adjusted hazard ratio, 0.52; 95% confidence interval, 0.35-0.76; P = .001)., Conclusions: In patients with persistent AF indicated for nonmitral valve surgery, a concomitant Cox-Maze procedure resulted in superior AF- and event-free survival compared with PVI, without increased risk of early mortality. These findings may assist decision making for surgical management of persistent AF concomitant with AVR and/or CABG., (Copyright © 2021 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Objective: A definitive treatment for patients with abdominal aortic aneurysm considering age and comorbidities has not been identified. In the present study, we retrospectively validated treatment outcomes in Japanese patients and proposed the treatment strategy of open surgical repair (OSR) and endovascular aneurysm repair (EVAR)., Methods: We retrospectively analyzed data for patients undergoing EVAR or OSR between 2006 and 2017. Patients with ruptured abdominal aortic aneurysm were excluded. We examined post-operative complications, operative mortality, re-intervention and prognosis., Results: Throughout the study period, 405 patients underwent EVAR and 176 patients underwent OSR. The percentage of patients with post-operative complications was 35.8% in the OSR group, compared with 13.1% in the EVAR group (P < 0.01). The operative mortality rate was 0.49% in the EVAR group and 0.57% in the OSR group (P = 1.00). With a multivariate analysis, age, hemodialysis, modified Frailty Index (mFI), and OSR were risk factors for post-operative complications. The 5-year re-intervention free survival rate was 63.0 % with hostile neck EVAR compared with 83.1 % with favorable neck EVAR and 86.1 % with OSR group (P < 0.01). With a multivariate analysis, hemodialysis, mFI, and hostile neck EVAR were risk factors for re-intervention. The 5-year overall survival rate was 51.9 % with hostile neck EVAR compared with 73.2 % with favorable neck EVAR and 79.0 % with OSR group (P < 0.01). With a multivariate analysis, age, mFI, and hostile neck EVAR were poor prognostic factors., Conclusion: Age, mFI, hemodialysis and hostile neck anatomy are useful predictors of post-operative complications, re-intervention and overall survival, and could be useful for informing treatment selection between OSR and EVAR., (Copyright © 2021. Published by Elsevier Inc.)

Background: In the TNM eighth edition, nutritional status and inflammatory scores are newly described as host-related prognostic factors for esophageal cancer, hepatocellular carcinoma, and pancreatic cancer. However, only age and race are listed as host-related prognostic factors for colorectal cancer., Objective: The purpose of this study was to evaluate the prognostic significance of nutritional and inflammatory scores for postoperative outcomes in patients with colorectal cancer., Design: This was a retrospective study using a database that prospectively collects data., Settings: The study was conducted at a high-volume multidisciplinary tertiary cancer center in Japan., Patients: Study participants were 1880 consecutive patients with stage II to III colorectal cancer who underwent curative resection at the National Cancer Center Hospital between 2004 and 2012. Two nutritional scores (prognostic nutritional index and controlling nutritional status score) and 4 inflammatory scores (modified Glasgow prognostic score, neutrophil:lymphocyte ratio, platelet:lymphocyte ratio, and C-reactive protein:albumin ratio) were calculated., Main Outcome Measures: Correlations of nutritional scores and inflammatory scores with overall survival and postoperative complications were measured., Results: After adjusting for key clinical and pathologic factors by multivariable analysis, 2 nutritional scores (prognostic nutritional index and controlling nutritional status score) and 2 inflammatory scores (neutrophil:lymphocyte ratio and C-reactive protein:albumin ratio) were independent prognostic factors for overall survival. With respect to discriminative ability, time-dependent receiver operating characteristic curves and Harrell concordance index revealed that prognostic nutritional index and controlling nutritional status score were superior to the 4 inflammatory scores for predicting overall survival. Multivariable logistic regression analyses also revealed that prognostic nutritional index, controlling nutritional status score, and C-reactive protein:albumin ratio were independent predictors for postoperative complications., Limitations: The retrospective design of the study was a limitation., Conclusions: Preoperative nutritional scores are promising host-related prognostic factors for overall survival and postoperative complications in patients with stage II and III colorectal cancer. See Video Abstract at http://links.lww.com/DCR/B587., Evaluacin De Score Nutricionales Preoperatorios Como Factores Pronsticos Para Sobrevida Y Complicaciones Postoperatorias En Pacientes Con Cancer Colorectal Etapa Ii Y Iii: ANTECEDENTES:En las últimas etapificaciones T-N-M, tanto el estado nutricional como inflamatorio han sido descritos como factores pronósticos en cáncer de esófago, hepático y pancreático. Sin embargo en cáncer colorectal solo la edad y la raza son enumerados como factores pronósticos.OBJETIVO:Evaluar la importancia pronóstica de los scores nutricionales e inflamatorias para los resultados posoperatorios en pacientes con cáncer colorrectal.DISEÑO:Estudio retrospectivo utilizando una base de datos.AJUSTE:Centro oncológico teciario en Japón.PACIENTES:Fueron incluidos en el estudio 1880 pacientes, consecutivos, con cancer colorectal etapa II y III sometidos a reseeción curativa en el National Cancer Center Hospital entre 2004 y 2012. Se aplicaron dos scores: nutricional (índice nutricional pronóstico y puntuación del estado nutricional) e inflamatorias (Glasgow modificada, proporción de neutrófilos a linfocitos, de plaquetas a linfocitos y de proteína C reactiva a albúmina).PRINCIPALES MEDIDAS DE RESULTADO:Evaluar scores nutricional e inflamatorio con sobrevida y complicaciones postoperatoria.RESULTADOS:Después de ajustar los factores clínicos y patológicos clave mediante análisis multivariable, dos scores nutricionales (índice nutricional pronóstico y puntuación del estado nutricional de control) y dos inflamatorias (proporción de neutrófilos a linfocitos y proporción de proteína C reactiva a albúmina) fueron pronósticos independientes factores para la sobrevida. Con respecto a la capacidad discriminativa, las curvas de características operativas del receptor, dependientes del tiempo y el índice de concordancia de Harrell, revelaron que el índice nutricional pronóstico y del estado nutricional de control eran superiores a las cuatro inflamatorias para predecir la sobrevida general. Los análisis de regresión logística multivariable también revelaron que el índice nutricional pronóstico, el estado nutricional de control y la relación proteína C reactiva / albúmina fueron predictores independientes de complicaciones postoperatorias.LIMITACIONES:Estudio de tipo retrospectivo.CONCLUSIONES:Los scores nutricionales preoperatorias son factores pronósticos prometedores relacionados con la sobrevida y las complicaciones postoperatorias en pacientes con cáncer colorrectal en estadio II y III. Consulte Video Resumen en http://links.lww.com/DCR/B587., (Copyright © The ASCRS 2021.)

Objective: We compared the surgical outcomes of minimally invasive esophagectomy (MIE) and open esophagectomy (OE) for esophageal cancer., Summary Background Data: MIE has become a widespread procedure. However, the definitive advantages of MIE over OE at a nationwide level have not been established., Methods: We analyzed patients who underwent esophagectomy for clinical stage 0 to III esophageal cancer from April 2014 to March 2017 using a Japanese inpatient database. We performed propensity score matching to compare in-hospital mortality and morbidities between MIE and OE, accounting for clustering of patients within hospitals., Results: Among 14,880 patients, propensity matching generated 4572 pairs. MIE was associated with lower incidences of in-hospital mortality (1.2% vs 1.7%, P = 0.048), surgical site infection (1.9% vs 2.6%, P = 0.04), anastomotic leakage (12.8% vs 16.8%, P < 0.001), blood transfusion (21.9% vs 33.8%, P < 0.001), reoperation (8.6% vs 9.9%, P = 0.03), tracheotomy (4.8% vs 6.3%, P = 0.002), and unplanned intubation (6.3% vs 8.4%, P < 0.001); a shorter postoperative length of stay (23 vs 26 days, P < 0.001); higher incidences of vocal cord dysfunction (9.2% vs 7.5%, P < 0.001) and prolonged intubation period after esophagectomy (23.2% vs 19.3%, P < 0.001); and a longer duration of anesthesia (408 vs 363 minutes, P < 0.001)., Conclusion: MIE had favorable outcomes in terms of in-hospital mortality, morbidities, and the postoperative hospital stay., Competing Interests: The authors report no conflicts of interest., (Copyright © 2019 Wolters Kluwer Health, Inc. All rights reserved.)

Background: Transvenous lead extraction (TLE) is necessary because of system infection, lead malfunction, or system upgrade. Patients with severe left ventricular dysfunction (SLVD) undergoing TLE may be at a higher risk because hemodynamic parameters may change unfavorably during or after TLE; however, this has not yet been clarified., Objective: The purpose of this study was to examine whether patients with SLVD undergoing TLE have higher mortality., Methods: All patients who underwent TLE were stratified as follows: patients with ejection fraction ≤ 35% (SLVD group) and those with ejection fraction > 35% (non-SLVD group)., Results: We assessed the data of 200 patients [SLVD group, 36 (18%); non-SLVD group, 164 (82%)]). Brain natriuretic peptide level and cardiac resynchronization therapy rate were higher in the SLVD group than in the non-SLVD group. There were no significant between-group differences in major complications and clinical success rates. Patients with SLVD were more likely to require additional hemodynamic support, such as catecholamine infusion, temporary atrium-ventricle sequential pacing, and temporary cardiac resynchronization therapy pacing (27.8% vs 1.2%; P < .001). The survival rate was not significantly different between the groups at 30 days and 1 year after TLE (SLVD vs non-SLVD: 30 days: 97.2% vs 99.4%; P = .215; 1 year: 80.6% vs 91.5%; P = .053). Multivariate Cox regression analysis revealed log brain natriuretic peptide and serum hemoglobin levels as predictors for 1-year mortality., Conclusion: The prognosis after TLE was comparable between patients with and without SLVD. However, additional hemodynamic support was often necessary for patients with SLVD., (Copyright © 2021 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Background: The effectiveness of endoscopic treatment for superficial esophageal squamous cell carcinoma in the elderly is unclear., Methods: We retrospectively studied efficacy and safety of endoscopic submucosal dissection for superficial esophageal squamous cell carcinoma in 358 patients at our hospital from July 2005 to December 2018. Patients were divided into elderly (≥75 years) and young (≤74 years) groups. Efficacy was evaluated based on overall survival and disease-specific survival, whereas safety was investigated based on the frequency of endoscopic submucosal dissection-related adverse events., Results: The median observation period was 50 months. The elderly group comprised 111 patients, and young group comprised 247 patients. In the elderly and young groups, 76 (68.5%) and 159 (64.4%) underwent curative resection (P = 0.450), 8 (7.2%) and 34 (13.8%) underwent non-curative resection plus additional treatment and 12 (10.8%) and 15 (6.0%) underwent follow-up, respectively. The frequency of additional treatment for non-curative resection was significantly lower in the elderly group (P = 0.023). The 3-year overall survival of the elderly and young groups was 85.6 and 94.1%, respectively (P = 0.003). The 3-year disease-specific survival of the elderly and young groups was 98.4 and 98.5% (P = 0.682), respectively. The frequency of endoscopic submucosal dissection-related adverse events did not differ significantly between the groups (P = 0.581). The Charlson Comorbidity Index ≥2 was an independent prognostic factor for survival in the elderly group (P = 0.010; hazard ratio, 5.570; 95% confidence interval, 1.519-20.421)., Conclusions: Endoscopic submucosal dissection for superficial esophageal squamous cell carcinoma in elderly patients is as safe as that for young patients. The evaluation of Charlson Comorbidity Index was considered to help estimate the prognosis of elderly patients., (© The Author(s) 2021. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permission@oup.com.)

Background: Little is known about the outcome of living-donor kidney transplantation (LDKT) performed in low-volume centers lacking the services of full-time transplant surgeons. This retrospective cohort study assessed the outcome of LDKT performed in a low-volume center by visiting transplant surgeons from a high-volume center and managed perioperatively by transplant nephrologists., Methods: We compared Japanese adult patients who had no donor-specific antibodies and underwent LDKT between 2006 and 2015 either in a low-volume (n = 31) or high-volume (n = 481) center. In the low-volume center, visiting transplant surgeons from the high-volume center conducted LDKT and transplant nephrologists managed the recipients peri- and postoperatively. The primary outcome was the composite of infection, cardiovascular disease, or cancer during 1-year follow-up. The outcomes of the low- and high-volume centers were compared using 1:2 propensity score matching., Results: After matching, 9 of 29 patients in the low-volume center (31.0%) and 16 of 58 patients in the high-volume center (27.6%) experienced the primary composite outcome (risk ratio = 1.13; 95% confidence interval, 0.57-2.23). There were no significant differences between the 2 groups in graft function at 1 year, all-cause graft loss, biopsy-proven rejection, and urological complications. However, the median duration of post-LDKT hospitalization was significantly longer in the low-volume center than in the high-volume center (23 and 16 days, respectively)., Conclusions: Among Japanese patients without preformed donor-specific antibodies, LDKT conducted at a low-volume center by visiting transplant surgeons from a high-volume center and managed clinically by transplant nephrologists was not associated with significantly higher risk of postoperative complications., (Copyright © 2021. Published by Elsevier Inc.)

Kidney transplantation is the most promising treatment to improve mortality and life quality in end-stage kidney disease; however, cancer remains a leading cause of death. Several factors including immunosuppressants might be associated with a gradual increase in cumulative cancer incidence after kidney transplantation. Risk factors for cancer and overall and cancer-specific survival were analyzed in 1973 kidney transplant recipients from three study institutions in Japan. The 5-, 10-, 20-, and 30-year overall and cancer-specific survival rates were 93.3%, 88.4%, 78.0%, and 63.6% and 99.4%, 98.0%, 95.3%, and 91.7%, respectively. The overall survival rate was significantly higher and the graft survival rate was significantly lower in recipients without cancer than in those with cancer. Older recipient age, longer dialysis duration before kidney transplantation, and history of transfusion were significant predictors of cancer. Dialysis duration before kidney transplantation was a prognostic factor of overall survival rate. Regarding cancer-specific survival rates, older recipient age and dialysis duration before kidney transplantation were prognostic factors of worse cancer-specific survival rates. The type of immunosuppressant was not associated with an increased cancer rate. Aggressiveness of immunosuppressant regimens or potent immunosuppressants might improve graft survival rate while inducing de novo cancer after kidney transplantation. Older age and longer dialysis duration before kidney transplantation were risk factors of cancer-specific survival rate., (© 2020 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.)

Background: Despite interest in surgeon and hospital volume effects on total gastrectomy (TG), clinical significance has not been confirmed in a large-scale population. This study aimed at clarifying the association of surgeon and hospital volume on postoperative mortality after TG for gastric cancer among Japanese patients in National Clinical Database (NCD)., Methods: Between 2011 and 2015, we retrospectively extracted data on TG for gastric cancer from the NCD. The primary outcome was operative mortality. We divided surgeon volume as the number of TGs performed by a patient's surgeon in the previous year: S1 (0-2 cases), S2 (3-9), S3 (10-25), S4 (26-79) and hospital volume by the number of TGs performed in the previous year: H1 (0-11 cases), H2 (12-26), H3 (27-146). We calculated the 95% confidence interval (CI) for the mortality rate based on odds ratios (OR) estimated from a hierarchical logistic regression model., Results: We analyzed 71,307 patients at 2051 institutions. Low-volume surgeons and hospitals had significantly older and poorer-risk patients with various comorbidities. The operative mortality rate decreased with surgeon volume, 2.5% in S1 and 0.6% in S4. The operative mortality was 3.1% in H1, 1.7% in H2, and 1.2% in H3. After risk adjustment for surgeon, hospital volume and patient characteristics, hospital volume was significantly associated with operative morality (H3: OR = 0.53, 95% CI 0.43-0.63)., Conclusions: We demonstrate hospital volume has an impact on postoperative mortality after TG in a nationwide population study. These findings suggest centralization may improve outcomes after TG.

Although surgical resection is the most preferred treatment for intracranial meningiomas, a detailed analysis of the surgery-related risks based on large population data has not been conducted to date. In this study, we analyzed the nation-wide brain tumor registry to assess the surgical risk factors for intracranial meningiomas to provide information for an optimal treatment strategy. Data of 4081 meningioma patients who underwent initial resection between 2001 and 2008 were extracted from the Brain Tumor Registry of Japan (BTRJ) database and reviewed for postoperative mortality, aggravation of Karnofsky Performance Score (KPS), and complications. The total in-hospital mortality rate was 0.59%. Male sex and tumor size ≥30 mm were independent risk factors for mortality. Among 4081 cases, 4.4% of patients had KPS that were lowered by 20 or more points at the time of discharge after surgery. Age ≥65 years, higher WHO grading, tumor location at the skull base, tumor size ≥30 mm, and non-gross total resections were associated with lowering of KPS scores by 20 or more points. The overall incidence of surgical complications was 19.3%. The rate of occurrence of new postoperative seizure in patients with supratentorial meningioma was 10.9%. All complications except for vascular complications occurred with significantly lower frequencies in asymptomatic patients than in symptomatic patients. Our results provide useful information regarding the surgical risks when surgical intervention is being considered for intracranial meningiomas. Surgery is an important option for asymptomatic meningiomas as the mortality rate and complication rate in the current study were sufficiently low.

Background: Heart failure (HF) is a risk factor for adverse post-procedural outcome after revascularization; however, it is unclear how left ventricular systolic dysfunction (LVSD) and clinical HF symptoms affect percutaneous coronary intervention (PCI) outcomes. We investigated the characteristics and long-term outcomes of patients with clinical HF or LVSD after PCI., Methods: This was a Japanese multicenter registry study of adult patients receiving PCI. Among 4689 consecutive patients who underwent PCI at 15 hospitals from January 2009 to December 2012, we analyzed 2634 (56.2%) with documented left ventricular ejection fraction (LVEF). They were divided into four groups based on clinical HF (symptoms or HF hospitalization) and LVEF [≥35% and <35% (HF due to LVSD)]. The primary outcome was major adverse cardiovascular events (MACE), comprising all-cause death, acute coronary syndrome, HF hospitalization, performance of coronary artery bypass grafting, and stroke within 2 years after the initial PCI., Results: Our findings revealed 354 patients (13.4%) with HF (clinical HF, n = 173, 48.9%; LVSD, n = 132, 37.3%; both, n = 49; 13.8%). The incidence of MACE was higher in patients with clinical HF or LVSD, and was largely due to higher non-cardiac death and HF hospitalization. After adjustment, clinical HF (hazard ratio 2.16, 95% confidence interval; 1.49-3.14) and lower LVEF (per 10%, hazard ratio 0.89, 95% confidence interval; 0.81-0.99) were independently associated with higher MACE risk., Conclusions: Clinical HF and LVSD were independently associated with adverse long-term clinical outcomes, particularly with non-cardiac death and HF readmission, in patients treated with PCI., (Copyright © 2020. Published by Elsevier Ltd.)

Background: Self-expandable metal stents (SEMSs) are widely used in patients with distal malignant biliary obstruction. A SEMS that can avoid occlusion as much as possible is desirable., Aims: The aim of this multicenter single-arm prospective study was to assess the clinical effectiveness and safety of a novel fully covered braided SEMS., Methods: We enrolled consecutive patients with distal malignant biliary obstruction between February 2016 and November 2017 at ten tertiary-care medical centers., Results: We included 79 patients with a median age of 76 years; 47 (59.5%) patients were men. The technical and clinical success rate was 98.7% and 93.6%, respectively. Recurrent biliary obstruction occurred in 14 patients (17.9%); stent ingrowth, overgrowth, migration, and other occurred in five (6.4%), four (5.1%), four (5.1%), and one (1.3%) patients, respectively. All reinterventions in patients with recurrent biliary obstruction were successful via the transpapillary approach. Adverse events occurred in 15 patients (19.2%); cholangitis, pancreatitis, and others occurred in ten (12.8%), three (3.8%), and two (2.6%) patients, respectively. The stent patency probability at 6 months was 48.5%. Median time to stent patency was 171 days, median time to recurrent biliary obstruction was 536 days, and median survival time was 195 days., Conclusions: We confirmed the utility and safety of a novel fully covered braided SEMS with low axial force and high radial force in patients with malignance biliary obstruction. This novel SEMS is recommended in patients with distal malignant biliary obstruction.

Background: In patients with unresectable hilar malignant biliary obstruction (MBO), bilateral metal stent placement is recommended. However, treatment selection between partially stent-in-stent (SIS) and side-by-side (SBS) methods is still controversial., Study: Clinical outcomes of bilateral metal stent placement by SBS and SIS methods for hilar MBO were retrospectively studied in four Japanese centers. While large-cell-type uncovered metal stents were placed above the papilla in SIS, braided-type uncovered metal stents were placed across the papilla in SBS., Results: A total of 64 patients with hilar MBO (40 SIS and 24 SBS) were included in the analysis. Technical success rate was 100% in SIS and 96% in SBS. Functional success rate was 93% in SIS and 96% in SBS. Early adverse event rates were higher in SBS (46%) than in SIS (23%), though not statistically significant (P = 0.09). Post-procedure pancreatitis was exclusively observed in SBS group (29%). Recurrent biliary obstruction rates were 48% and 43%, and the median time to recurrent biliary obstruction was 169 and 205 days in SIS and SBS, respectively., Conclusions: Other than a trend to higher adverse event rates including post-procedure pancreatitis in SBS, clinical outcomes of SIS and SBS methods were comparable in patients with unresectable hilar MBO.

Background: No guidelines are available for defining the extent of lymph node (LN) dissection in patients with remnant gastric carcinoma (RGC). Hence, this retrospective study aimed to determine the optimal extent of LN dissection in patients with RGC., Methods: We retrospectively evaluated the therapeutic outcomes of node dissection for RGC from a nationwide registry. When the metastatic rate or 5-year survival rate exceeded 10%, dissection was recommended. We calculated the dissection index by multiplying the incidence of metastasis at that nodal station by the 5-year survival rate of patients with metastasis at the station. A dissection index of > 1.0 was considered significant., Results: We included 1133 patients with RGC (T2-T4 tumor) who had undergone distal gastrectomy as the primary surgery for the evaluation of the survival benefit of nodal dissection. Any regional node station was considered significant. When the primary surgery was for malignant disease, the index was high for Nos. 3 (10.2), 7 (9.5), 1 (7.1), and 9 (8.0) nodes. For nodes at the splenic hilum, the index value was 4.4, which was higher than that for the perigastric nodes (Nos. 4sa and 4sb). The index for No. 10 nodes was the highest (10.5) when tumors involved a greater curvature., Conclusions: The therapeutic strategy for RGC remains the same, regardless of the histology of the primary disease during the initial surgery. Total gastrectomy and dissection of the perigastric LNs (Nos. 1-4), suprapancreatic LNs (Nos. 7-9 and 11), and LNs at the splenic hilum (No. 10) are justified.

Background: The Fitzgerald classification expresses the extension of hematoma from the ruptured abdominal aortic aneurysm (rAAA) and is related to a patient's preoperative status. The objective of this study was to propose a new decision-making method for emergency surgeries, endovascular aortic repair (EVAR), or open repair (OR) for rAAA based on the Fitzgerald classification using preoperative computed tomography images., Materials and Methods: A multicenter observational study was performed with a questionnaire survey of rAAA from August 2010 to July 2015 in Hokkaido, Japan, and sent to 20 institutions participating in the Hokkaido Society of Aortic Stent Graft. We included 205 patients who could be stratified by the Fitzgerald classification as the subjects of this study. We categorized these patients into Fitzgerald classes I and II (first category, n = 72) and classes III and IV (second category, n = 133). The short-term results of both EVAR and OR cases were examined in the 2 categories., Results: In the first category, patients in the EVAR group were older than those in the OR group. Nonetheless, the in-hospital mortality rate was lower in the EVAR group than in the OR group (0% vs. 18%; P = 0.019). In the second category, there was no difference in preoperative factors between the groups. The EVAR group showed a higher incidence rate of postoperative abdominal compartment syndrome than the OR group (12% vs. 2%; P = 0.042). The in-hospital mortality rate was comparable between the groups (24% vs. 25%; P = 0.80). Although there were no deaths in the EVAR group without preoperative shock, in-hospital mortality in the EVAR group of the second category with shock was 41% (vs. 28% in the OR group; P = 0.27). Furthermore, mortality in the EVAR group with Fitzgerald class IV was 100% (vs. 29% in the OR group; P = 0.049)., Conclusions: EVAR is recommended in Fitzgerald class I or II and also in Fitzgerald class III or IV without shock because the results of EVAR were better than those of OR. Because all patients who underwent EVAR died in Fitzgerald class IV, OR would be beneficial in this patient population., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Objective: We retrospectively evaluated the impact of postoperative complications on long-term outcomes after curative resection for colorectal cancer (CRC), using propensity-score analysis (PSA)., Patients and Methods: We reviewed data from 673 consecutive patients with stage I to III CRC, who underwent curative resections between 2005 and 2017. Patients were divided into the complication group (Clavien-Dindo [CD] grade ≥ 3) and the control group (others). We performed PSA to obtain unbiased estimates of the effects of the oncological background on each outcome., Results: We matched for sex, age, American Society of Anesthesiologists grade, location (right colon/left colon/rectum), histology (tub1/tub2/por), pathological tumor depth, and lymph node metastases. Eighty-five patients (12.6%) developed postoperative complications with CD grade ≥ 3. After PSA, 81 patients were included in each group. The complication group showed significantly worse relapse-free survival (RFS) than the control group (5-year RFS rate: 62% vs 77%; P = .047). In multivariate analysis with inverse probability of treatment weights, the complication group had a higher risk of relapse or death than the control group (hazard ratio: 2.08, 95% confidence interval:1.3-3.3; P = .018)., Conclusions: Postoperative complications (CD grade ≥ 3) could cause poor long-term outcomes in patients with stage I to III CRC; their presence requires appropriate adjuvant chemotherapy and follow-up., (© 2020 Wiley Periodicals, Inc.)

Background: This study evaluates our 18-year experience of total arch replacement in the octogenarian and nonagenarian population., Methods: Between October 1999 and March 2018, a total of 740 patients underwent total arch replacement at our institution. A total of 139 patients were aged 80 years or more (83.1 ± 2.8 years), and 601 patients were aged less than 80 years (66.9 ± 11.3 years). Early and late outcomes were compared between the groups., Results: In the group aged 80 years or more, operative mortality occurred in 12 patients (8.6%) and significantly improved over time (P = .010). Operative mortality was significantly higher in the group aged 80 years or more (P = .033) when compared with the group aged less than 80 years (4.0%). Regarding postoperative complications, deep sternal wound infection, pneumonia, and tracheostomy occurred in significantly more patients in the group aged 80 years or more. In the group aged 80 years or more, there were 52 late deaths, with 4 aortic-related deaths. Overall survival was 55.4% ± 5.0% at 5 years and 32.2% ± 6.1% at 8 years. Multivariable Cox-hazard regression analysis demonstrated that chronic kidney disease, nonelective surgery, and concurrent procedures were significant risk factors for overall survival in the group aged 80 years or more. Cumulative incidence for reoperation was significantly lower in the group aged 80 years or more (8.7% at 5 years) compared with the group aged less than 80 years (14.2% at 5 years)., Conclusions: Total arch replacement was performed with an acceptable overall survival in octogenarians and nonagenarians, although operative mortality was higher than in younger patients. However, older patients had a lesser burden of reoperation compared with younger patients., (Copyright © 2019 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Objectives: To investigate the relationship between body mass index (BMI) and early outcomes, and specific types of morbidities associated with low and high BMI, in patients undergoing coronary artery bypass grafting., Methods: This was a retrospective study on isolated coronary artery bypass grafting patients (aged ≥60 years) between 2008 and 2017 in the Japan Cardiovascular Surgery Database. The primary end point was defined as operative mortality. The secondary end point was combined morbidity (ie, operative mortality, reoperation for bleeding, stroke, new onset of hemodialysis, mediastinitis, and prolonged ventilation). Patient characteristics and outcomes were compared among BMI groups. Spline curves were fit between BMI and outcomes. Multivariable logistic regression models with categorized BMI and generalized additive models with spline-transformed BMI were used to estimate and visualize the effect of BMI adjusted for other covariates., Results: A total of 96,058 patients were included in the analysis. Low (<18.5) and high (≥30) BMI were both associated with a higher risk of mortality (low: adjusted odds ratio, 1.34; 95% confidence interval, 1.16-1.54; P < .0001, and high: adjusted odds ratio, 2.10; 95% confidence interval, 1.70-2.59; P < .0001) and combined morbidity (low: adjusted odds ratio, 1.18; 95% confidence interval, 1.08-1.29; P = .0002 and high: adjusted odds ratio, 1.82; 95% confidence interval, 1.63-2.03; P < .0001). Low and high BMI were associated with different types of morbidities. In models using spline transformation, the deviation of BMI from a proximately 21 to 23 was proportionally associated with increased risk., Conclusions: In patients undergoing coronary artery bypass grafting, low and high BMI were risk factors of mortality associated with different types of morbidities, which may warrant tailored preventive approaches., (Copyright © 2019 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Background: This study retrospectively evaluated the long-term patient outcomes and durability of the Mosaic aortic porcine bioprosthesis in the Japan Mosaic valve long-term multicenter study.Methods and Results:We reviewed the records of 1,202 patients who underwent aortic valve replacement with the Mosaic bioprosthesis at 10 centers in Japan (1999-2014). Patient data were collected using Research Electronic Data Capture. Patient survival was determined by Kaplan-Meier methodology. Freedom from structural valve deterioration (SVD) and valve-related reoperation and death were determined by actuarial methods. The median (interquartile range [IQR]) age of the cohort was 76 (70-80) years. The median (IQR) follow-up period was 3.52 (1.71-5.35) years. The longest follow-up was 15.8 years. The 30-day mortality rate was 2.3%. The 12-year actuarial survival rate was 59.9±7.5%, and the freedom from valve-related death was 81.1±7.9%. The freedom from reoperation was 86.4±2.6% at 12 years. The freedom from SVD at 12 years was 93.5±2.9% for patients aged ≥65 years and 98.2±1.8% for those aged <65 years. The median (IQR) systolic pressure gradient was 17 (12-23) and 19 (12-25) mmHg at 1 and 10 years, respectively. The median (IQR) effective orifice area was 1.2 (1.1-1.5) and 1.1 (1-1.5) cm 2 at 1 and 10 years, respectively., Conclusions: The Mosaic porcine bioprosthesis showed satisfactory long-term outcomes over 12 years.

Background: Few well-controlled studies have compared postoperative complications between Billroth I (B-I) and Roux-en-Y (R-Y). The aim of the present study was to compare the incidence of overall and severe postoperative complications by reconstruction method after distal gastrectomy., Methods: We performed a multi-institutional dataset study of patients who underwent distal gastrectomy with B-I or R-Y reconstruction from 2010 to 2014. Using propensity scores to strictly balance the significant variables, we compared postoperative complications between the techniques., Results: After matching, we enrolled 1014 patients (n = 507 in each group). The incidence of postoperative complications in the R-Y group was significantly higher vs the B-I group (29% vs 17%, P < 0.0001). The incidence of intra-abdominal abscess (4.3% vs 1.8%, P = 0.0177), bowel obstruction (2.6% vs 0.6%, P = 0.0203), and delayed gastric emptying (5.3% vs 1.0%, P < 0.0001) in the R-Y group was significantly higher vs the B-I group, respectively; we saw no significant difference in leakage (3.4% vs 4.1%, P = 0.5084). The incidence of grade ≥ III severe postoperative complications in the R-Y group was significantly higher vs the B-I group (13% vs 7.1%, P = 0.0013). Multivariable analysis showed that R-Y reconstruction was a strong independent risk factor for overall postoperative complications (odds ratio 1.58, P = 0.0044) and grade ≥ III severe postoperative complications (odds ratio 1.75, P = 0.0127). A forest plot revealed that R-Y reconstruction was associated with a greater risk of both overall and grade ≥ III severe postoperative complications in any subgroups., Conclusions: R-Y reconstruction was associated with increasing overall postoperative complications, as well as severe postoperative complications.

Background: We compared survival after resection by systematic segmentectomy (SS) versus non-anatomic resection (NAR) in patients with small, solitary hepatocellular carcinomas (HCCs)., Methods: To control for variables, we used 1-to-1 propensity score matching to compare outcomes after surgery among 615 patients in Japan between 2003 and 2007 with primary solitary HCCs ≤3 cm in diameter who received SS (n = 114) or NAR (n = 114) of one Couinaud segment with complete removal of the portal territory containing the tumor., Results: We successfully matched SS and NAR patients with primary HCC tumors ≤3.0 cm and similar liver function and tumor characteristics. The SS group had significantly longer recurrence-free survival (RFS; hazard ratio [HR] 1.56, 95% confidence interval [CI] 1.10-2.21, P = .013) and overall survival (OS; HR 1.67, 95% CI 1.07-2.60, P = .025) than the NAR group. Among patients who lost >400 mL of blood during surgery, had chronic hepatitis, or had cirrhosis, the RFS and OS were better in the SS group than in the NAR group. In Cox proportional hazard analysis, SS offered a better prognosis than NAR., Conclusions: Systematic segmentectomy decreases the risk of recurrence and improves OS in patients with primary, solitary HCC tumors of ≤3 cm in diameter., (© 2020 Japanese Society of Hepato-Biliary-Pancreatic Surgery.)

Objective: This study aimed to assess the sex differences in clinical presentation and outcomes of Japanese patients with ruptured aortic aneurysm (rAA) using a large nationwide claims-based database in Japan., Methods: We identified patients hospitalized in certified teaching hospitals in Japan with rAA between April 1, 2012, and March 31, 2015. Patients' characteristics and in-hospital outcomes were compared between men and women. The Barthel index was used for evaluating functional status at discharge by examining the ability to perform basic daily activities., Results: Of 7086 eligible patients, 32.3% (2291/7086) were women. Women were older than men (81.9 years vs 76.1 years; P < .001), had higher prevalence of coma at admission (33.2% vs 25.2%; P < .001), and were less likely to undergo emergency operation including endovascular aneurysm repair (35.7% vs 51.1%; P < .001). The unadjusted mortality rate (62.5% vs 52.0%; P < .001) and Barthel index at discharge (78.7 vs 86.1; P < .001) were significantly worse in women than in men. However, multilevel mixed-effect logistic regression analyses showed that female sex itself was not an independent predictor for in-hospital death (odds ratio [OR], 0.90; 95% confidence interval [CI], 0.78-1.04; P = .17). Older age, coma at admission, and vasopressor use were detected as independent predictors for in-hospital death. The same results were confirmed for each rupture site. Stratified analyses showed that older women (threshold, 80 years; OR, 0.81; 95% CI, 0.66-0.98; P = .028) and those who underwent emergency operation (OR, 0.75; 95% CI, 0.61-0.93; P = .009) showed significantly better outcomes than men., Conclusions: In a univariate analysis, female patients with rAA showed worse mortality than men because of their older age, more severe clinical presentation, and low emergency operation rate. However, after adjustment for covariates, female sex itself was not associated with increased mortality., (Copyright © 2019 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Background: The optimal management of preexisting severe aortic stenosis (AS) in patients undergoing noncardiac surgery (non-CS) remains uncertain. This study aimed to investigate the safety and effectiveness of percutaneous aortic valve intervention (PAVI) in patients with AS before non-CS., Methods: We analyzed pooled data within a multicenter Japanese registry from 118 patients with severe AS who underwent PAVI before non-CS. Sixty patients underwent percutaneous balloon aortic valvuloplasty (BAV) and 58 patients underwent transcatheter aortic valve replacement (TAVR). The groups' baseline characteristics, perioperative complications, and 30-day mortality and midterm mortality after non-CS were compared., Results: The postprocedural mean pressure gradient was higher in the BAV group than in the TAVR group (35.0 ± 11.5 mmHg vs. 11.5 ± 4.8 mmHg, p < 0.001). The non-CS operation risk did not differ between the groups (p = 0.69). One patient in each group experienced a noncardiac death (p = 0.74), and the 30-day mortality rate after non-CS was 1.7%. Heart failure occurred in 2 patients in each group (p = 0.68). One patient in the TAVR group experienced a non-disabling stroke, and no myocardial infarctions occurred. Consequently, the combined adverse events were 5.0% and 6.9% in the 2 groups (p = 0.48). The bleeding rates during the non-CS were similar in both groups (33.3% vs. 25.9%, p = 0.25). There were no differences between the groups regarding midterm mortality (p = 0.60), whereas 53.3% of the patients in the BAV group required invasive treatment of their AS during follow-up., Conclusions: Among patients with severe AS, PAVI before non-CS reduces the AS severity and may contribute to procedural safety during non-CS., Competing Interests: Disclosures Dr. Yamamoto, Dr. Tada, Dr. Naganuma, Dr. Shirai, Dr. Mizutani, and Dr. Watanabe are clinical proctors for Edwards Lifesciences and Medtronic. Dr. Araki, Dr. Tabata, Dr. Takagi, Dr. Higashimori, and Dr. Hayashida are clinical proctors of Edwards Lifesciences. Dr. Ueno is a clinical proctor for Medtronic. The remaining authors have nothing to disclose., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Objective: This study aimed to assess the effect of chronic steroid use on periprocedural complications and clinical outcomes after transcatheter aortic valve replacement (TAVR)., Background: Chronic steroid use increases the risk of periprocedural complications and mortality during surgery., Methods: We investigated 1,313 consecutive patients with aortic stenosis who underwent transfemoral (TF)-TAVR using data from a Japanese multicenter registry. The baseline characteristics, periprocedural complications including vascular complications (VCs), access route related VCs, and clinical outcomes were compared between patients in the steroid group and nonsteroid group., Results: Major VCs and access route VCs occurred more in the steroid group than in the nonsteroid group (13.4 vs. 5.8%, p = .019; 20.9% vs. 9.8%, p = .004). Especially in the surgical cut-down group, the rate of access route VCs was differed between the two groups (28.0% vs. 7.5%, p = .003). The 30-day mortality rates were similar between the two groups (0% vs. 1.4%, p = .39). In the propensity score-matched model, the higher incidence of major VCs in the steroid group was maintained, although early mortality was similar in the two groups., Conclusions: Although chronic steroid therapy is not associated with increased early mortality, chronic steroid use may affect periprocedural VCs and access route VCs mainly due to surgical cut-down in patients following TF-TAVR., (© 2019 Wiley Periodicals, Inc.)

Endosaccular coiling is recognized as a feasible method for treating unruptured intracranial aneurysms (UIAs). We retrospectively reviewed cases of UIAs treated by coiling in the Japanese Registry of Neuroendovascular Therapy (JR-NET) 3, a nationwide survey of NET between 2010 and 2014, the beginning period of intracranial stents in Japan. Data were extracted for 6844 UIAs (6619 procedures) from 40,169 registered records of all NETs in the JR-NET 3 databases. The features of the aneurysms and procedures, immediate radiographic findings, procedure-related complications, and clinical outcomes at 30 days after the procedures were assessed. Of 6844 UIAs, 81.8% were located in the anterior circulation. The mean patient age was 61.3 years (72.4% females). Compared with the preceding JR-NET 1 and 2, there were significant increases (P <0.05) in the rates of the following in JR-NET 3: wide-necked and small UIAs measuring <10 mm (from 56.4% to 58.8%), adjunctive techniques (54.8% to 71.8%), and stent usage (1.1% to 22.1%). Both pre- (85.6% to 96.7%) and post-procedural (84.0% to 94.6%) antiplatelet therapy were more frequently administered in JR-NET 3. Although procedure-related complication rates did not differ between the two groups, ischemic complication rates increased from 4.6% to 5.9%, leading to an increase in the 30-day morbidity (modified Rankin Scale >2) from 2.1% to 2.8%. In conclusion, introduction of neck-bridge stent was associated with an increase in cases of wide-necked aneurysms. However, the ischemic complication rate increased despite the greater use of periprocedural antiplatelet therapy.

Background: Lung transplantation (LT) is a reliable therapeutic option for end-stage pulmonary lymphangioleiomyomatosis (LAM). Long-term outcome of LAM recipients after LT remains unknown. The aim of this study was to describe the outcomes of LT for LAM with a long-term follow-up, comparing those for other diseases in the same period., Methods: We retrospectively reviewed consecutive 145 LT recipients between 1998 and 2015 at Okayama University Hospital with minimum 3-year follow-up., Results: Twelve LAM recipients including nine sporadic-LAM and three tuberous sclerosis complex -LAM were identified. Nine of 12 underwent bilateral LT including four living-donor lobar LT. There was no significant difference in overall survival between the two groups. (P = 0.15). Chronic lung allograft dysfunction free survival rate in LAM compared with other diseases tended to be better (P = 0.058). However, the rate of requiring hemodialysis was significantly higher in LAM recipients than in the recipients of other diseases (P = 0.047). Notably, 8 of 12 (67%) LAM patients encountered LAM-related complication including chylothorax and pneumothorax, seven (58%) had proliferative diseases consisting of renal angiomyolipoma and recurrent LAM. Nine patients required mTOR inhibitors for LAM-related problems, contributing to improved control of LAM-related problems. While all nine recipients of bilateral LT have still survived, two patients died of diseases in their native lungs and one required re-LT among three recipients of single LT., Conclusion: Although the rates of LAM-related complications were unexpectedly high in the long term, LT is a feasible therapeutic option for patients with advanced pulmonary LAM., (© 2019 John Wiley & Sons Ltd.)

Background: Aortoesophageal fistula (AEF) is a life-threatening late complication that can occur after thoracic endovascular aortic repair (TEVAR). More data are required to identify the optimal treatment strategy for AEF developed after TEVAR. The aim of this study was to clarify the current status of surgical treatments for AEF developed after TEVAR and the outcomes of these treatments., Methods: The Japan Esophageal Society conducted a questionnaire survey targeting authorized or semi-authorized institutes at Authorized Institutes for Board Certified Esophageal Surgeons. Thirty-nine patients with AEF developed after TEVAR were identified from 15 institutes. Data on patient demographics, treatment performed, and survival rate were obtained by the questionnaire. The Kaplan-Meier method was used for survival analysis and differences in the survival rates., Results: Esophagectomy and aortic replacement were performed in 32 and 22 patients, respectively, and 22 underwent both procedures. Postoperative complications were observed in 24 patients (75.0%). Complications with Clavien-Dindo Grade III or higher were observed in 53.1% of patients. Operative and hospital mortality rates were 3.1% and 18.8%, respectively. The survival rate in patients who underwent esophagectomy was higher than in those who did not (P < 0.0001). The survival of patients who underwent both esophagectomy and aortic replacement was also higher than in those who did not (P < 0.0001)., Conclusion: Esophagectomy combined with aortic replacement can offer a long-term treatment strategy with higher survival rates in patients who develop AEF after TEVAR. Because of the high incidence of postoperative morbidity and mortality, these types of surgery should only be performed in centers with both experienced esophageal and cardiovascular surgical teams.

Introduction: In 2010, a large-scale multi-institutional study in Japan showed a good prognosis for percutaneous endoscopic gastrostomy (PEG). However, the function and efficacy of PEG are not fully understood by patients, families, and health-care professionals; thus, the number of PEG treatments in Japan has declined. Therefore, we aimed to investigate the safety of the PEG procedure and subsequent survival after PEG., Methods: In total, 249 PEGs were performed at Juzenkai Hospital from 2005 to 2017. PEG was originally performed using the pull method and then by a modified introducer method from mid-2011. We examined procedure-related complications and survival rates after PEG., Results: Fifty-one (20.5%) procedure-related complications occurred; emergency surgery was required in 4 cases. Infections accounted for 76.5% (39/51) of complications. More infections occurred with the pull method than with the modified introducer method. The 1-year survival rate was 66.8%; the median survival time was 678 days. Nine patients (3.6%) died within 30 days; no deaths were directly related to PEG. Sex, age, and albumin level before surgery significantly influenced the prognosis., Conclusion: Due to changes in the PEG insertion method and other factors, PEG has become a safer treatment method. Additionally, PEG-based nutritional supplementation is associated with adequate survival., (© 2021 S. Karger AG, Basel.)

Objectives: The advantage of valve-sparing root replacement (VSRR) over aortic root replacement with a composite valve graft (CVG) remains unclear. We compared these 2 procedures with regard to early outcomes with propensity score matching using the Japan Cardiovascular Surgery Database., Methods: Of 5303 patients from the Japan Cardiovascular Surgery Database who had undergone aortic root replacement in 2008 to 2017, emergent/urgent or redo cases and those with infective endocarditis or aortic stenosis were excluded (included n = 3841). Two propensity score-matched groups treated with VSRR or CVG replacement (n = 1164 each) were established., Results: Overall, VSRR was more frequently performed for younger patients with Marfan syndrome with lower operative risk and aortic regurgitation grade compared with CVG replacement. After matching, a weaker but similar trend still existed in baseline characteristics. Although more concomitant procedures were performed in the CVG group, myocardial ischemia and cardiopulmonary bypass time was significantly longer in the VSRR group (median, 193 and 245 minutes) than the CVG group (172 and 223 minutes, both P < .01). The CVG group was associated with a significantly greater incidence of postoperative stroke (2.5% vs 1.1%, P = .01) and prolonged ventilation >72 hours (7.0% vs 4.6%, P = .02). In-hospital mortality rates were significantly greater in the CVG group (1.8%) than the VSRR group (0.8%, P = .02)., Conclusions: In overall Japanese institutions, VSRR was more frequently performed for patients at low risk and was associated with better morbidity and mortality rates than CVG replacement. After matching, VSRR was also associated with better morbidity and mortality rates despite longer procedure time., (Copyright © 2019 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Background: Ventricular septal defect (VSD) after myocardial infarction (MI) is a rare but fatal complication. We report patients' characteristics and operative outcomes after surgical repair of post-MI VSD using a national database of Japan.Methods and Results:This was a retrospective review of the Japan Adult Cardiovascular Surgery Database (JCVSD) to identify adults (age ≥18 years) who underwent surgical repair of post-MI VSD between 2008 and 2014. The primary outcome was operative death. We identified 1,397 patients (671 male [48%], 74.1±9.3 years old) undergoing surgical repair of post-MI VSD among 288,736 patients undergoing cardiac surgery enrolled in the JCVSD during the same period. Of these, 1,075 (77.0%) were supported preoperatively with an intra-aortic balloon pump. Surgical status was urgent in 391 (28.0%) and emergency/salvage in 731 (52.3%). Concomitant coronary artery bypass grafting was performed in 475 (34.0%). Overall 30-day and operative mortalities were 24.3% and 33.0%, respectively. Operative mortality varied according to surgical status: 15.6% in elective, 30.9% in urgent, and 40.6% in emergency/salvage cases. Multivariable analysis identified advanced age and emergency/salvage status as being strongly associated with increased odds of operative death., Conclusions: Post-MI VSD remains a devastating complication in Japan as well as in the USA and Europe.

Objectives: We aimed to assess real-world clinical outcomes of transcatheter aortic valve replacement (TAVR) in Japan., Background: Data are limited concerning procedural safety and valve performance following TAVR in Japanese. A program by an on-site proctor and procedure screening system was applied during TAVR introduction., Methods: We consecutively enrolled 1613 patients who underwent TAVR using data from the Optimized CathEter vAlvular iNtervention (OCEAN) Japanese registry, which consists of 14 centers. Baseline characteristics and procedural outcomes including combined early 30-day non-safety, and mortality rates were assessed among 4 groups, divided into quartiles (Q1-Q4)., Results: Most patients were women (70.4%), elderly (84.4 ± 5.1 years), and had a median Society of Thoracic Surgeons score of 6.7(4.7-9.5). The overall 30-day mortality, combined early non-safety, and cumulative 1-year mortality rates were 1.7%, 15.1%, and 11.3%, respectively. Thirty-day mortality was not affected by center experience differences divided into quartiles (1.0%, 2.0%, 2.5%, 1.5%, p = 0.404), whereas 30-day early safety was significantly improved (19.1%, 17.9%, 14.6%, 8.9%, p < 0.001). Thirty-day mortality was 0% under transfemoral on-site proctor. Cox-regression multivariate analysis revealed that male sex, clinical frailty scale, New York Heart Association class, creatinine, albumin, hemoglobin, liver disease, and non-transfemoral approach were independent predictive factors of increased midterm mortality risk., Conclusions: Owning to the global supporting system in Japan, excellent early and midterm outcomes have been achieved to overcome the learning curve of the newly introduced TAVR procedure., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Background: The aim of the present study was to clarify the association between preoperative liver function and complications after hepatectomy., Methods: The study included 11,686 patients registered in the National Clinical Database for 2015 for whom data on indocyanine green at 15 min (ICG15) and hepatectomy were available. The patients were divided into four groups: group A (ICG15 <10%; n = 5,661), group B (ICG15 10% to <20%; n = 4,381), group C (ICG15 20% to <30%; n = 1,173) and group D (ICG15 >30%; n = 463). Hepatectomy procedures were classified as partial resection (n = 3,934), systematic subsegmentectomy (n = 2,055), monosectionectomy (n = 2,043), bisectionectomy (n = 2,993) and trisectionectomy (n = 208). Complications were classified using the Clavien-Dindo classification (CD) and evaluated by ICG15 category and procedure type., Results: Complications more severe than CD III increased significantly as the operation time lengthened and the intraoperative bleeding volume increased (P < 0.001). ICG15 category was positively associated with operative death, >CD III complications, surgical site infection (SSI), liver failure, and intractable ascites for many of the major hepatectomy procedures, but not with bile leakage. More complications were observed in patients outside the Makuuchi criteria than in those within the criteria., Conclusions: Operation time and intraoperative bleeding volume are significantly associated with severe postoperative complications in patients undergoing hepatectomy. ICG15 is a good indicator predictive of operative death, >CD III complications, SSI, liver failure and intractable ascites., (© 2019 Japanese Society of Hepato-Biliary-Pancreatic Surgery.)

Precis: Wider area bleb revision using bleb knife with adjunctive mitomycin C (MMC) had a good success rate, according to strict success criteria, except in patients with neovascular glaucoma (NVG)., Purpose: We determined the efficacy of wider area bleb revision after filtering surgery using bleb knife with adjunctive MMC., Patients and Methods: In this retrospective single-center study, we analyzed 86 patients with glaucoma (46 primary open-angle, 18 exfoliations, 13 secondary, and 9 neovascular) after bleb revision using bleb knife with adjunctive MMC after a minimum follow-up of 6 months. A Kaplan-Meier survival analysis with log-rank tests and Cox proportional hazards regression analyses were performed. The main outcome measure was a successful initial bleb revision using bleb knife with adjunctive MMC, arbitrarily defined as intraocular pressure (IOP) control <15 mm Hg without any IOP-lowering medication, additional bleb revision, or glaucoma surgery., Results: The mean time since the initial filtering surgery was 243.8 days, and the mean prebleb revision IOP was 22.0±4.8 mm Hg. The total cumulative success rate of the bleb revision using bleb knife with MMC was 49% at 6 months and 30% at 1 year. Patients with primary open-angle glaucoma had the best success rate (64% at 6 mo and 40% at 1 y). Log-rank tests revealed that patients with NVG had the worst prognosis (P<0.01). NVG was the only significant risk factor identified for short survival time (odds ratio, 167.10; 95% confidence interval, 1.78-15620.44; P=0.027)., Conclusion: Wider area bleb revision using bleb knife with adjunctive MMC had a good success rate, according to strict success criteria, except in patients with NVG.

Background: The purpose of this study was to investigate if the transcatheter aortic valve replacement (TAVR) risk score can independently predict outcomes following TAVR, and to evaluate its predictive performance.Methods and Results:This retrospective multicenter study comprised 682 patients with severe aortic stenosis who underwent TAVR. The primary endpoint was all-cause death following TAVR. The clinical model was established using variables identified as independent predictors in the multivariate analysis. Incremental values were assessed after adding atrial fibrillation, body mass index (BMI), and serum albumin to the TAVR risk score in receiver-operating characteristic analysis. The median TAVR risk score was 2.1% with a mean follow-up of 505 days. On Kaplan-Meier analysis, a TAVR risk score >4% had lowest survival rate, whereas TAVR risk score ≤2% had the highest survival rate at 3 years (log-rank P<0.001). The multivariate Cox regression analysis found the TAVR risk score was independently associated with all-cause death, and demonstrated moderate predictive performance for predicting all-cause death at 3 years. However, if each independent predictor is added to the model, it significantly increased discriminatory performance, particularly with BMI and serum albumin level., Conclusions: We demonstrated that the TAVR risk score could independently predict mid-term death following TAVR, and had greater predictive performance for predicting all-cause death at 3 years with BMI and serum albumin level.

Objectives: This study investigated the relationship between the timing of ventricular tachycardia or ventricular fibrillation (VT or VF) and prognosis in patients undergoing primary percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI)., Background: It is unknown whether the timing of VT/VF occurrence affects the prognosis of patients with AMI., Methods: From January 2004 to December 2014, 1004 patients with AMI underwent primary PCI. Of these patients, 888 did not have VT/VF (non-VT/VF group) and 116 had sustained VT/VF during prehospitalization or hospitalization. Patients with VT/VF were divided into two groups: early VT/VF (VT/VF occurrence before and within 2 days of admission, 92 patients) and late VT/VF (VT/VF occurrence >2 days after admission; 24 patients) groups., Results: The frequency of VT/VF occurrence was high between the day of admission and the 2nd day and between days 6 and 10 of hospitalization. The late VT/VF group had a significantly longer onset-to-balloon time, lower ejection fraction, poorer renal function, and higher creatine phosphokinase (CK)-MB level on admission (p< 0.001). They also had a lower 30-day cardiac survival rate than the early VT/VF and non-VT/VF groups (42% vs. 76% vs. 96%, p < 0.001). Moreover, independent predictors of in-hospital cardiac mortality among patients with AMI who had sustained VT/VF were higher peak CK-MB [Odds ratio (OR: 1.001, 95%confidence interval (CI): 1.000-1.002, p= 0.03)], higher Killip class (OR: 1.484, 95%CI 1.017-2.165, p= 0.04), and late VT/VF (OR: 3.436, 95%CI 1.115-10.59, p= 0.03)., Conclusions: The timing of VT/VF occurrences had a bimodal peak. Although late VT/VF occurrence after primary PCI was less frequent than early VT/VF occurrence, patients with late VT/VF had a very poor prognosis., Competing Interests: The authors declare that there are no conflicts of interest., (Copyright © 2019 Takuma Takada et al.)

Objective: To compare operative outcomes of laparoscopic surgery compared with laparotomy in patients with moderate to severe pelvic inflammatory disease (PID)., Methods: Using the Diagnosis Procedure Combination database, a national inpatient database for acute-care inpatients in Japan, we performed a large, nationwide retrospective cohort study. We identified all patients aged 18 years or older who were diagnosed with PID with or without tubo-ovarian abscess and were admitted to a participating hospital from July 2010 to March 2016. We excluded patients who were pregnant, had cancer, or for whom data were missing. We compared outcomes between patients who underwent laparoscopic surgery compared with laparotomy. Propensity score-matched analyses were performed to compare operative outcomes including postoperative length of stay, surgical complications, in-hospital deaths, and revision surgery., Results: Of 27,841 patients with PID, 4,419 (15.9%) underwent surgical intervention. From among 749 women undergoing laparoscopy and 3,670 women undergoing laparotomy for PID, 740 pairs were created for propensity score matching. The laparoscopic group had shorter operation duration (125 vs 166 min), fewer blood transfusions (4.7% vs 10.0%), and shorter length of hospital stay (median 5 days vs 7 days; all P<.001) compared with the laparotomy group. There were no significant differences between groups for in-hospital deaths, surgical complications, and revision surgery., Conclusion: Laparoscopic surgery may have clinical advantages over laparotomy in patients diagnosed with severe PID.

Objective: The efficacy of thoracic endovascular aortic repair (TEVAR) for retrograde type A aortic dissection (r-TAAD) with the entry tear in the descending aorta has not been clarified., Methods: The medical records of 31 patients who underwent TEVAR for r-TAAD at three institutions between May 1997 and January 2016 were retrospectively reviewed., Results: The mean age of the patients (30 men and 1 woman) was 64 ± 11 years. The entry tear was located in the descending thoracic aorta in all patients. Seven patients (23%) had dissection-related complications. The false lumen of the ascending aorta was patent in 13 patients (42%) and thrombosed in 18 (58%). The maximum diameter of the ascending aorta was 45 ± 4 mm. TEVAR was performed in the acute phase in 24 patients (77%) and in the subacute phase in 7 (23%). Only one patient (3%) died of aortic rupture within 30 days after TEVAR. Early aorta-related adverse events were observed in eight patients (26%), of whom five underwent additional interventions. The mean follow-up period was 99 ± 69 months. There were no late aorta-related deaths, although five patients died of other causes during follow-up. Overall survival rates at 1 year, 5 years, and 10 years were 97%, 93%, and 80%, respectively. Late aorta-related adverse events were observed in seven patients (23%), of whom five underwent additional interventions. Aorta-related event-free survival rates at 1 year, 5 years, and 10 years were 58%, 58%, and 51%, respectively., Conclusions: TEVAR for r-TAAD seems promising in terms of survival. However, the incidence of postoperative aorta-related adverse events is not negligible, so careful selection of patients is important. In addition, close follow-up is mandatory after TEVAR to avoid catastrophic consequences., (Copyright © 2018 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Background: Smoking cessation is important in the management of patients who require pulmonary resection. However, the impact of short-term smoking cessation on the surgical outcome remains unclear., Methods: A retrospective study was conducted on patients with stage I to III primary lung cancer who underwent resection between 2012 and 2016. The rate of operative mortality and morbidity were evaluated according to smoking status. The relationship between the preoperative interval of smoking cessation and pulmonary complications after surgery was also examined., Results: This study included 666 patients, of whom 256 (38.4%) were never smokers and 410 (61.6%) were smokers. Significant differences were found between the smokers and never smokers regarding the 90-day mortality rate (2.0% versus 0%, p = 0.025) and respiratory complications (22.3% versus 3.5%, p < 0.001). A multivariate analysis indicated that smoking (odds ratio [OR] 2.8, p = 0.017), forced expiratory volume in 1 second/forced vital capacity less than 0.7 (OR 2.6, p = 0.001), percentage of diffusing capacity of the lung for carbon monoxide less than 40% (OR 4.2, p = < 0.001), and clinical stage of lung cancer (OR 2.3, p = 0.005) were predictors of pulmonary complications after pulmonary resection. In comparison with never smokers, the ORs for pulmonary complications at each cessation interval (current smoker/cessation for <1month, 1 to 3 months, 3 to 6 months, 6 to 12 months, and >12 months) were 12.9 (p < 0.001), 10.3 (p < 0.001), 8.5 (p < 0.001), 6.3 (p = 0.011), 6.0 (p = 0.003), and 5.0 (p < 0.001), respectively., Conclusions: A longer period of cessation might be more effective for reducing the risk of pulmonary complications. Smoking cessation at any time is valuable for lung cancer surgery., (Copyright © 2019 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Cirrhosis is a significant adverse factor of cardiac surgeries. Transcatheter aortic valve implantation (TAVI) has evolved as a less invasive therapy for aortic stenosis, whereas detailed case analysis of TAVI in cirrhotic patients is limited.Among 444 consecutive patients who underwent TAVI in the Sakakibara Heart Institute between October 2013 and January 2018, we retrospectively reviewed 11 patients (2.5%) with cirrhosis. All outcomes were defined according to the Valve Academic Research Consortium-2 criteria.The median age of the patients was 82 years, and eight (73%) were female. Seven patients (64%) were Child-Turcotte-Pugh class A, and four patients (36%) were class B. The Model for End-Stage Liver Disease score was 10 (7.0-13). TAVI was performed using Edwards SAPIEN XT/SAPIEN3 in nine patients (82%), and Medtronic CoreValve/Evolut R in two patients (18%), via transfemoral (n = 8, 73%) or transapical (n = 3, 27%) approach. The device success rate was 100% and no extracorporeal circulation had been inducted. No death, stroke, life-threatening bleeding, and acute kidney injury stage 2 or 3 occurred within 30 days, but three major bleeding events (27%) were documented (two access-site bleeding in transapical approach, and one pulmonary hemorrhage caused by transient mitral regurgitation). During a median follow-up of 493 days, four deaths had occurred, and the mid-term survival rate was 81% and 65% at one and two years each.TAVI is a promising therapeutic option for patients with cirrhosis. Further study should be needed regarding optimal patient selection and procedures in patients with cirrhosis.

Background: Broncho-pleural fistula (BPF) and respiratory failure (RF) are life-threatening complications after lung cancer surgery and can result in long-term hospitalization and decreased quality of life. Risk assessments for BPF and RF in addition to mortality and major morbidities are indispensable in surgical decision-making and perioperative care., Methods: The characteristics and operative data of 80,095 patients who had undergone lung cancer surgery were derived from the 2014 and 2015 National Clinical Database (NCD) of Japan datasets. After excluding 1501 patients, risk models were developed from these data and validated by another dataset for 42,352 patients derived from the 2016 NCD dataset. Receiver operating characteristic curves were generated for postoperative BPF and RF development. The concordance-index was used to assess the discriminatory ability and validity of the model., Results: BPF and RF occurred in 259 (0.3%) and 420 patients (0.5%), respectively, in the model development dataset and in 129 (0.3%) and 198 patients (0.5%), respectively, in the model validation dataset. Characteristic variables including types of surgery and comorbidities were identified as risk factors for BPF and RF, respectively. The concordance indexes of assessments for BPF and RF were 0.847 (p < 0.001) and 0.848 (p < 0.001), respectively, for the development dataset and 0.850 (p < 0.001) and 0.844 (p < 0.001), respectively, for the validation dataset., Conclusions: These models are satisfactory for predicting BPF and RF after lung cancer surgery in Japan and could guide preoperative assessment and optimal measures for preventing BPF and RF.

Background: Because of aggressive immunosuppression, heart transplant recipients have a high risk of de novo malignancy, which is a major cause of death and worse prognosis, regardless of the type. However, the impact of de novo malignancy on Japanese heart transplant recipients is unknown., Methods: We analyzed 103 Japanese heart transplant recipients over 18-years-old at the time of transplantation between April 1999 and April 2017. Patient characteristics and prognosis were compared between heart transplant recipients with or without de novo malignancy after heart transplantation (HTx). Additionally, univariate and multivariate analyses for the risk factors of de novo malignancy after HTx were performed., Results: De novo malignancy developed in 7 patients (6.8%; post-transplant lymphoproliferative disorders, n=3; Bowen's disease, n=1; colon cancer, n=2; bladder cancer, n=1). Follow-up time and previous antibody mediated rejection (AMR)≥grade 1 were risk factors of de novo malignancy after HTx in multivariate analysis (OR: 1.19, 95% CI: 1.00-1.42, p=0.043; and OR: 10.7, 95% CI: 1.37-83.68, p=0.038, respectively). History of malignancy was a potential risk factor, albeit not significant (OR: 23.05, 95% CI: 0.99-534.53, p=0.071). The survival rates in patients with de novo malignancy was significantly lower than in those without de novo malignancy (3-year survival rate: 100% versus 67%, p=0.0025)., Conclusions: Long follow-up time and previous AMR≥grade 1 were risk factors of de novo malignancy after HTx. Japanese heart transplant recipients with de novo malignancy have worse prognosis; therefore, screening examinations are important for early diagnosis., (Copyright © 2018 Japanese College of Cardiology. Published by Elsevier Ltd. All rights reserved.)

Background: Gastric cancer is sometimes complicated by obstructive jaundice. However, ERCP may be challenging in patients who have advanced gastric cancer, or recurrent gastric cancer after surgical resection that is complicated by obstructive jaundice. In such cases, percutaneous transhepatic biliary drainage (PTBD) is considered. Recently, EUS-guided biliary drainage (EUS-BD) has been developed. We conducted a retrospective study to compare the efficacy of EUS-BD and PTBD in patients with obstructive jaundice due to gastric cancer., Methods: Patients with gastric cancer complicated with obstructive jaundice who were contraindicated for standard ERCP were enrolled., Results: A total of 47 consecutive patients were enrolled during the study period. The technical success rates of PTBD and EUS-BD were 88.9% (16/18) and 96.7% (29/30), respectively (P = 0.64). The stent patency period, including patient death was equivalent between the two groups (EUS-BD vs. PTBD: 188.4 days vs. 200.9 days, P = 0.974). Time to stent dysfunction in the EUS-BD group (391.1 days) was not significantly different as compared to that in the PTBD group (398.1 days) (P = 0.78). Adverse events were relatively severe in the PTBD group., Conclusions: Given the relative severity of adverse events in the PTBD group, EUS-BD might be the procedure of choice for gastric cancer patients with contraindications by inability to perform ERCP., (Copyright © 2018 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.)

Background: Catheter interventions for residual lesions in the early postoperative period after CHD operations are still not established as a reliable treatment option., Methods: We retrospectively reviewed our institutional experience of cardiac catheterisations and catheter interventions performed in the early postoperative period. We classified our patients into two groups. The "hyper" acute phase group - operation to cardiac catheterisation of ⩽7 days - and acute phase group - operation to cardiac catheterisation from 7 to 30 days., Results: Of the 47 patients, catheter interventions were performed in 38 patients (81%). The success rate of the intervention was 96% in the acute phase group and 90% in the "hyper" acute phase group. The overall success rate was 95%. There were two self-limited complications in the acute phase group, but not in the "hyper" acute phase group. There were four cases of catheter interventions performed for a newly reconstructed aortic arch, and those procedures were also safe and effective., Conclusions: Cardiac catheterisations and catheter interventions were safe and effective not only in the early postoperative period but also in the very early postoperative period. Catheter interventions for the left-sided heart in the early postoperative period were also safe and effective.

Background: Improving patients' oral hygiene is an option for preventing postoperative pneumonia that may be caused by aspiration of oral and pharyngeal secretions. Whether preoperative oral care by a dentist can decrease postoperative complications remains controversial. A retrospective cohort study was undertaken to assess the association between preoperative oral care and postoperative complications among patients who underwent major cancer surgery., Methods: The nationwide administrative claims database in Japan was analysed. Patients were identified who underwent resection of head and neck, oesophageal, gastric, colorectal, lung or liver cancer between May 2012 and December 2015. The primary outcomes were postoperative pneumonia and all-cause mortality within 30 days of surgery. Patient background was adjusted for with inverse probability of treatment weighting using propensity scoring., Results: Of 509 179 patients studied, 81 632 (16·0 per cent) received preoperative oral care from a dentist. A total of 15 724 patients (3·09 per cent) had postoperative pneumonia and 1734 (0·34 per cent) died within 30 days of surgery. After adjustment for potential confounding factors, preoperative oral care by a dentist was significantly associated with a decrease in postoperative pneumonia (3·28 versus 3·76 per cent; risk difference - 0·48 (95 per cent c.i. -0·64 to-0·32) per cent) and all-cause mortality within 30 days of surgery (0·30 versus 0·42 per cent; risk difference - 0·12 (-0·17 to -0·07) per cent)., Conclusion: Preoperative oral care by a dentist significantly reduced postoperative complications in patients who underwent cancer surgery., (© 2018 BJS Society Ltd Published by John Wiley & Sons Ltd.)

Background: Nutritional condition is one marker of patients' frailty. The Geriatric Nutritional Risk Index (GNRI) is a well-known marker of nutritional status. This study sought to assess the clinical outcomes of GNRI after transcatheter aortic valve replacement (TAVR)., Methods: We evaluated the GNRI value of 1,613 patients who underwent TAVR using data from a Japanese multicenter registry. According to baseline GNRI, patients were classified into 3 groups: GNRI ≥92 (n = 1,085; 67.3%), GNRI 82-92 (n = 396; 24.6%), and GNRI ≤82 (n = 132; 8.2%). Baseline characteristics, procedural outcomes, and cumulative mortality rates were compared. In addition, GNRI correlations with other frailty components (gait speed, grip strength, and Clinical Frailty Scale) and Society of Thoracic Surgeons (STS) score were also evaluated., Results: Significantly increased mortality rates were observed across the 3 groups at 30 days (0.9%, 2.3%, and 6.8%, respectively; P < .001) and 1 year (6.5%, 16.4%, and 36.4%, respectively; P < .001). Both GNRI 82-92 and GNRI ≤82 (as a reference for GNRI ≥92) were independently associated with increased midterm mortality in the Cox regression multivariate model (hazard ratio: 1.97, 3.60; 95% confidence interval: 1.37-2.84, 2.30-5.64; P < .001, P < .001, respectively). The GNRI value was significantly correlated with gait speed (Spearman ρ = -0.15, P < .001), grip strength (ρ = 0.25, P < .001), Clinical Frailty Scale (ρ = -0.24, P < .001), and STS score (ρ = -0.29, P < .001)., Conclusions: GNRI is related to both frailty components and the STS score and is an important surrogate marker for predicting worse clinical outcomes after TAVR. Assessment of the GNRI may be considered when deciding on TAVR., (Copyright © 2018. Published by Elsevier Inc.)

The relation between C-reactive protein (CRP) level on admission and mortality after transcatheter aortic valve implantation (TAVI) remains unclear. To evaluate the impact of serum CRP level on mortality after TAVI, we assessed 1,016 patients with CRP who underwent TAVI and 538 patients with high-sensitive CRP (hs-CRP) level who underwent TAVI on admission in the OCEAN (Optimized Transcatheter Valvular Intervention)-TAVI registry. Study population was stratified into 2 groups (high/low), according to the median of CRP and hs-CRP on admission. We assessed the impact of high CRP and hs-CRP level on all-cause death after TAVI. During 2-year follow-up, all-cause death after TAVI was 9.4% in patients with CRP and 11.9% in patients with hs-CRP. Median value of serum CRP was 0.10 mg/dl in both CRP and hs-CRP. Patients with high CRP (>0.10 mg/dl) had significantly higher incidence of all-cause death compared with those with low CRP (11.5% vs 7.6%, log-rank p = 0.015). Multivariate Cox regression analysis with a time-varying covariate demonstrated that high CRP was an independent predictor of all-cause death within the first 3 months (hazard ratio 2.78, 95% CI 1.30 to 5.95) compared with from 3 months to 2 years (hazard ratio 0.80, 95% CI 0.47 to 1.36) (P for interaction = 0.008). Inversely, these results were not observed in the stratification using hs-CRP on admission. In conclusion, high CRP on admission was significantly associated with an increased risk of all-cause death after TAVI, particularly within the first 3 months after TAVI. Risk stratification using CRP may be a simple and useful strategy to identify high-risk patients who undergo TAVI., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Background: The introduction of transcatheter aortic valve implantation (TAVI) into Japan was strictly controlled to optimize patient outcomes. The goal of this study was to assess if increasing experience during the introduction of this procedure was associated with outcomes.Methods and Results:The initial 1,752 patients registered in the Japanese national TAVI registry were included in the study. The association between operator procedure number and incidence of the early safety endpoint at 30 days (ESE30) as defined in the Valve Academic Research Consortium-2 consensus document was evaluated. Patients were divided into 4 groups by quartiles of procedure count (Groups I-IV in order of increasing number of procedures). Median patient age was 85 years, and 30.5% were male. The 30-day mortality rate was 1.4% (n=24), and 78 patients (7.9%) experienced 95 ESE30. Among the variables included in the model, ESE30 was associated with non-transfemoral approach (P=0.004), renal dysfunction (Cr >2.0 mg/dL) (P=0.01) and NYHA class III/IV (P=0.04). ESE30 incidence was not significantly different between Groups I-III and Group IV. Spline plots demonstrated that experience of 15-20 cases in total was needed to achieve a consistent low risk of ESE30., Conclusions: Increasing experience was associated with better outcomes, but to a lesser degree than in previous reports. Our findings suggested that the risks associated with the learning curve process were appropriately mitigated.