The study objective was to report the clinical outcomes of open surgery for acute aortic dissection by using the Japan Cardiovascular Database.
Between 2013 and 2018, a total of 29,486 patients with ...acute aortic dissection who underwent open surgery were registered in the Japan Cardiovascular Database. Some 50% of patients were male. Age of patients at surgery was 59.8 ± 14.2 years; 61% of patients were aged less than 65 years, and 21% of patients were aged more than 75 years. Connective tissue disease was found in 1.2% of patients. Some 13% of patients had disturbed consciousness, and 12% of patients had cardiogenic shock. Some 11% of patients had moderate or severe aortic valve regurgitation, and 2.3% of patients had acute myocardial infarction. Some 94% of patients underwent surgery within 24 hours after diagnosis. Antegrade cerebral perfusion was used in 74% of patients, hypothermic circulatory arrest with retrograde cerebral perfusion was used in 17.1% of patients, and deep hypothermic circulatory arrest was used in 9.4% of patients. Cardiopulmonary bypass time was 216 ± 90 minutes, and cardiac ischemic time was 132 ± 60 minutes. Lowest body temperature was 24.6°C ± 3.2°C. Replacement of the ascending aorta (zone I) was performed in 69% of patients, and total arch replacement (zone 0 to zone II, III-) was performed in 29% of patients. The aortic valve was replaced in 7.9% of patients and repaired in 4.4% of patients.
The 30-day mortality was 9.2%, and in-hospital mortality was 11%. The number of operations has increased through the study periods. The in-hospital mortality has been stable or in a decreasing trend. Major complications consisted of stroke in 12% of patients, new hemodialysis in 7.3% of patients, spinal cord ischemia in 3.9% of patients, and prolonged ventilation in 15% of patients.
Approximately 30,000 patients with acute aortic dissection in the recent 6 years (2013 - 2018) underwent open surgery according to the nationwide Japanese database. The number of operations has increased, and in-hospital mortality has been stable or in a decreasing trend. Although the early outcomes are acceptable, there is still room for improvement in patients with preoperative comorbidities.
Nationwide analysis of acute AAD using the JCVSD 2013 to 2018. From left top to right bottom: patient enrollment, patient age at surgery, urgency of surgery, yearly number of surgery and hospital death, yearly number of postoperative complications, range of replacing aorta, aortic valve procedures, and mode of brain protection. CABG, Coronary artery bypass grafting; CHD, congestive heart disease; LV, left ventricle; VAD, ventricular assist device; SCI, spinal cord ischemia; HD, hemodialysis. Display omitted
Background
The morbidity rate after pancreaticoduodenectomy remains high. The objectives of this retrospective cohort study were to clarify the risk factors associated with serious morbidity ...(Clavien–Dindo classification grades IV–V), and create complication risk calculators using the Japanese National Clinical Database.
Methods
Between 2011 and 2012, data from 17,564 patients who underwent pancreaticoduodenectomy at 1,311 institutions in Japan were recorded in this database. The morbidity rate and associated risk factors were analyzed.
Results
The overall and serious morbidity rates were 41.6% and 4.5%, respectively. A pancreatic fistula (PF) with an International Study Group of Pancreatic Fistula (ISGPF) grade C was significantly associated with serious morbidity (P < 0.001). Twenty‐one variables were considered statistically significant predictors of serious complications, and 15 of them overlapped with those of a PF with ISGPF grade C. The predictors included age, sex, obesity, functional status, smoking status, the presence of a comorbidity, non‐pancreatic cancer, combined vascular resection, and several abnormal laboratory results. C‐indices of the risk models for serious morbidity and grade C PF were 0.708 and 0.700, respectively.
Conclusions
Preventing a PF grade C is important for decreasing the serious morbidity rate and these risk calculations contribute to adequate patient selection.
HighlightAoki and colleagues clarified the risk factors associated with serious morbidity (Clavien‐Dindo classification grades IV–V) and created risk calculators using a Japanese nationwide database of 17,564 patients after pancreaticoduodenectomy. Preventing pancreatic fistula grade C is important for reducing serious morbidity and these risk calculations contribute to more appropriate patient selection.
Background
Although laparoscopic total gastrectomy (LTG) is considered a technically demanding procedure with safety issues, it has been performed in several hospitals in Japan. Data from a ...nationwide web-based data entry system for surgical procedures (NCD) that started enrollment in 2011 are now available for analysis.
Methods
A retrospective cohort study was conducted using data from 32,144 patients who underwent total gastrectomy and were registered in the NCD database between January 2012 and December 2013. Mortality and morbidities were compared between patients who received LTG and those who underwent open total gastrectomy (OTG) in the propensity score-matched Stage I cohort and Stage II–IV cohort.
Results
There was no significant difference in mortality rate between LTG and OTG in both cohorts. Operating time was significantly longer in LTG while the blood loss was smaller. In the Stage I cohort, LTG, performed in 33.6% of the patients, was associated with significantly shorter hospital stay but significantly higher incidence of readmission, reoperation, and anastomotic leakage (5.4% vs. 3.6%,
p
< 0.01). In the Stage II–IV cohort, LTG was performed in only 8.8% of the patients and was associated with significantly higher incidence of leakage (5.7% vs. 3.6%,
p
< 0.02) although the hospital stay was shorter (15 days vs. 17 days,
p
< 0.001).
Conclusion
LTG was more discreetly introduced than distal gastrectomy, but remained a technically demanding procedure as of 2013. This procedure should be performed only among the well-trained and informed laparoscopic team.
Purpose
To illustrate the utility of the self‐controlled study design for studies without an active comparator, we compared the results of a cohort design study with a non‐user comparator with those ...of a self‐controlled design study in evaluating the risk of varenicline on cardiovascular outcomes, using a Japanese medical claims database.
Methods
The participating smokers were identified from health‐screening results collected between May 2008 and April 2017. Using a non‐user‐comparator cohort study design, we estimated the hazard ratios (HRs) and 95% confidence intervals (CIs) of varenicline on initial hospitalization with cardiovascular outcomes using Cox's model adjusted for patients' sex, age, medical history, medication history, and health‐screening results. Using a self‐controlled study design, the within‐subject HR was estimated using a stratified Cox's model adjusted for medical history, medication history, and health‐screening results. The estimate from a recent meta‐analysis was considered the gold standard (risk ratio: 1.03).
Results
We identified 460 464 smokers (398 694 males 86.6%; mean (standard deviation) age: 42.9 10.8 years) in the database. Of these, 11 561 had been dispensed varenicline at least once, and 4511 had experienced cardiovascular outcomes. The estimate of the non‐user‐comparator cohort study design exceeded the gold standard (HR 95% CI: 2.04 1.22–3.42), whereas that of the self‐controlled study design was close to the gold standard (within‐subject HR 95% CI: 1.12 0.27–4.70).
Conclusions
The self‐controlled study design is useful alternative to a non‐user‐comparator cohort design when evaluating the risk of medications relative to their non‐use, based on a medical information database.
Background
Postoperative intra-abdominal infectious complication (PIIC) after gastrectomy for gastric cancer worsens in-hospital death or long-term survival. However, the methodology for PIIC ...preoperative risk assessment remains unestablished. We aimed to develop a preoperative risk model for postgastrectomy PIIC.
Methods
We collected 183,936 patients’ data on distal or total gastrectomy performed in 2013–2016 for gastric cancer from the Japanese National Clinical Database and divided into development (2013–2015;
n
= 140,558) and validation (2016;
n
= 43,378) cohort. The primary outcome was the incidence of PIIC. The risk model for PIIC was developed using 18 preoperative factors: age, sex, body mass index, activities of daily living, 12 comorbidity types, gastric cancer stage, and surgical procedure in the development cohort. Secondarily, we developed another model based on the new scoring system for clinical use using selected factors.
Results
The overall incidence of PIIC was 4.7%, including 2.6%, 1.7%, and 1.3% in anastomotic leakage, pancreatic fistula, and intra-abdominal abscess, respectively. Among the 18 preoperative factors, male odds ratio, (OR) 1.92, obesity (OR, 1.52–1.96), peripheral vascular disease (OR, 1.55), steroid use (OR, 1.83), and total gastrectomy (OR, 1.89) strongly correlated with PIIC incidence. The entire model using the 18 factors had good discrimination and calibration in the validation cohort. We selected eight relevant factors to create a simple scoring system, using which we categorized the patients into three risk groups, which showed good calibration.
Conclusion
Using nationwide clinical practice data, we created a preoperative risk model for postgastrectomy PIIC for gastric cancer.
Background: Limited data are available for clinical outcomes in patients who underwent urgent or emergency transcatheter aortic valve implantation (TAVI). This study investigated in-hospital and ...1-year outcomes and explored prognostic covariates in urgent/emergency TAVI using nationwide registry data.Methods and Results: Among 26,775 patients who underwent TAVI between August 2013 and December 2019, 25,495 with 1-year follow-up information were analyzed in this study. Baseline and procedural characteristics, as well as clinical adverse events, were compared between the urgent/emergency and elective TAVI groups. The primary outcome was all-cause mortality within 1 year after TAVI. Multivariable Cox regression models were constructed to identify independent predictors after urgent or emergency TAVI. Urgent or emergency TAVI was performed in 578 (2.3%) patients. The Society of Thoracic Surgeons score was significantly higher in the urgent/emergency than elective TAVI group (13.3% vs. 6.0%; P<0.001). Device success rate was comparable between the 2 groups. All-cause death-free survival within 1 year was lower in the urgent/emergency than elective TAVI group (77.2% vs. 92.2%; log rank P<0.001). Malignancy, albumin and creatinine concentrations, ejection fraction, and mean pressure gradient were associated with 1-year mortality in the urgent/emergency TAVI group.Conclusions: Despite higher surgical risk and more comorbidities, the procedure was successfully performed in patients undergoing urgent/emergency TAVI, although it should be noted that prognosis was worse than for elective TAVI.
Background:The trend of the initial treatment strategy for pulmonary arterial hypertension (PAH) has changed from monotherapies to upfront combination therapies. This study analyzed treatments and ...outcomes in Japanese patients with PAH, using data from the Japan PH Registry (JAPHR), which is the first organized multicenter registry for PAH in Japan.Methods and Results:We studied 189 consecutive patients (108 treatment-naïve and 81 background therapy patients) with PAH in 8 pulmonary hypertension (PH) centers enrolled from April 2008 to March 2013. We performed retrospective survival analyses and analyzed the association between upfront combination and hemodynamic improvement, adjusting for baseline NYHA classification status. Among the 189 patients, 1-, 2-, and 3-year survival rates were 97.0% (95% CI: 92.1–98.4), 92.6% (95% CI: 87.0–95.9), and 88.2% (95% CI: 81.3–92.7), respectively. In the treatment-naïve cohort, 33% of the patients received upfront combination therapy. In this cohort, 1-, 2-, and 3-year survival rates were 97.6% (95% CI: 90.6–99.4), 97.6% (95% CI: 90.6–99.4), and 95.7% (95% CI: 86.9–98.6), respectively. Patients on upfront combination therapy were 5.27-fold more likely to show hemodynamic improvement at the first follow-up compared with monotherapy (95% CI: 2.68–10.36).Conclusions:According to JAPHR data, initial upfront combination therapy is associated with improvement in hemodynamic status.
Background:Transcatheter aortic valve replacement (TAVR) has been performed more and more frequently in elderly patients with aortic stenosis. We investigated the association of in-hospital ...availability of TAVR on outcomes of surgical aortic valve replacement (SAVR) in the era of TAVR.Methods and Results:We utilized data from the Japan Adult Cardiovascular Surgery Database. Between October 2013 and December 2016, 9,330 patients aged ≥80 years underwent isolated SAVR or SAVR with coronary artery bypass grafting in 557 centers in Japan. We assessed the associations of in-hospital TAVR availability with operative mortality and composite complications adjusting for each patient’s characteristics, JapanSCORE predicted the risk scores, and hospital volumes of SAVR using generalized estimation equation methods. Observed operative mortality rates were 3.4% in all centers, 2.0% in TAVR centers and 4.0% in non-TAVR centers. The multivariable analyses showed that TAVR centers had statistically significantly lower operative mortality compared with non-TAVR centers among all patients (odds ratio 0.60, 95% confidence interval 0.41–0.89, P=0.01) and among intermediate/high-risk patients (odds ratio 0.52, 95% confidence interval 0.32–0.85, P<0.01) but not among low-risk patients (odds ratio 0.82, 95% confidence interval 0.44–1.51, P=0.52).Conclusions:In-hospital TAVR availability was associated with better outcomes of SAVR among elderly patients. This association was statistically significant among intermediate/high-risk patients but not significant among low-risk patients.
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.
The aim of the present study was to clarify the association between preoperative liver function and complications after hepatectomy.
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.
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.
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.
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