Percutaneous coronary intervention during the COVID-19 pandemic in Japan: Insights from the nationwide registration data.

[Background] Coronavirus disease 2019 (COVID-19) has negatively affected access to healthcare systems and treatment timelines. This study was designed to explore the impact of the COVID-19 pandemic on patients who underwent percutaneous coronary intervention (PCI). [Methods] From January 2019 to December 2020, 489, 001 patients from 1068 institutions were registered in the Japanese nationwide PCI (J-PCI) registry. We constructed generalized linear models to assess the difference in the daily number of patients and in-hospital outcomes between 2019 and 2020. [Findings] In total, 207 institutions (19·3%) had closed or restricted access during the first COVID-19 outbreak in May 2020; the number of closed or restricted institutions had plateaued at a median of 121 institutions (11·3%). The daily case volume of PCI significantly decreased in 2020 (by 6·7% compared with that in 2019; 95% confidence interval [CI], 6·2–7·2%; p < 0·001). Marked differences in the presentation of PCI patients were observed; more patients presented with ST-segment elevation myocardial infarction (18·3% vs. 17·5%; p < 0·001), acute heart failure (4·49% vs. 4·30%; p = 0·001), cardiogenic shock (3·79% vs. 3·45%; p < 0·001), and cardiopulmonary arrest (2·12% vs. 2·00%; p = 0·002) in 2020. The excess adjusted in-hospital mortality rate in patients treated in 2020 relative to those treated in 2019 was significant (adjusted odds ratio, 1·054; 95% CI, 1·004–1·107; p = 0·03). [Interpretation] While the number of patients who underwent PCI substantially decreased during the COVID-19 pandemic, more patients presented with high-risk characteristics and were associated with significantly higher adjusted in-hospital mortality. [Funding] The J-PCI registry is a registry led and supported by the Japanese Association of Cardiovascular Intervention and Therapeutics. The present study was supported by the Grant-in-Aid from the Ministry of Health and Labour (No. 20IA2002 and 21FA1015), the Grants-in-Aid for Scientific Research from the Japan Society for the Promotion of Science (KAKENHI; No. 21K08064), and the Japan Agency for Medical Research and Development (No. 17ek0210097h000)

Variation in in-hospital mortality and its association with percutaneous coronary intervention-related bleeding complications : A report from nationwide registry in Japan.

Large-scale registries have demonstrated that in-hospital mortality after percutaneous coronary intervention (PCI) varies widely across institutions. However, whether this variation is related to major procedural complications (e.g., bleeding) is unclear. In this study, institutional variation in in-hospital mortality and its association with PCI-related bleeding complications were investigated. We analyzed 388,866 procedures at 718 hospitals performed from 2017 to 2018, using data from a nationwide PCI registry in Japan. Hospitals were stratified into quintiles according to risk-adjusted in-hospital mortality (very low, low, medium, high, and very high). Incidence of bleeding complications, defined as procedure-related bleeding events that required a blood transfusion, and in-hospital mortality in patients who developed bleeding complications were calculated for each quintile. Overall, 4,048 (1.04%) in-hospital deaths and 1,535 (0.39%) bleeding complications occurred. Among patients with bleeding complications, 270 (17.6%) died during hospitalization. In-hospital mortality ranged from 0.22% to 2.46% in very low to very high mortality hospitals. The rate of bleeding complications varied modestly from 0.27% to 0.57% (odds ratio, 1.95; 95% confidence interval, 1.58–2.39). However, mortality after bleeding complications markedly increased by quintile and was 6-fold higher in very high mortality hospitals than very low mortality hospitals (29.0% vs. 4.8%; odds ratio, 12.2; 95% confidence interval, 6.90–21.7). In conclusion, institutional variation in in-hospital mortality after PCI was associated with procedure-related bleeding complications, and this variation was largely driven by differences in mortality after bleeding complications rather than difference in their incidence. These findings underscore the importance of efforts toward reducing not only bleeding complications but also, even more importantly, subsequent mortality once they have occurred

Outcomes of acute coronary syndrome patients with concurrent extra-cardiac vascular disease in the era of transradial coronary intervention: A retrospective multicenter cohort study.

BACKGROUND:Extra-cardiac vascular diseases (ECVDs), such as cerebrovascular disease (CVD) or peripheral arterial disease (PAD), are frequently observed among patients with acute coronary syndrome (ACS). However, it is not clear how these conditions affect patient outcomes in the era of transradial coronary intervention (TRI). METHODS AND RESULTS:Among 7,980 patients with ACS whose data were extracted from the multicenter Japanese percutaneous coronary intervention (PCI) registry between August 2008 and March 2017, 888 (11.1%) had one concurrent ECVD (either PAD [345 patients: 4.3%] or CVD [543 patients; 6.8%]), while 87 patients (1.1%) had both PAD and CVD. Overall, the presence of ECVD was associated with a higher risk of mortality (odds ratio [OR]: 1.728; 95% confidence interval [CI]: 1.183-2.524) and bleeding complications (OR: 1.430; 95% CI: 1.028-2.004). There was evidence of interaction between ECVD severity and procedural access site on bleeding complication on the additive scale (relative excess risk due to interaction: 0.669, 95% CI: -0.563-1.900) and on the multiplicative scale (OR: 2.105; 95% CI: 1.075-4.122). While the incidence of death among patients with ECVD remained constant during the study period, bleeding complications among patients with ECVD rapidly decreased from 2015 to 2017, in association with the increasing number of TRI. CONCLUSIONS:Overall, the presence of ECVD was a risk factor for adverse outcomes after PCI for ACS, both mortality and bleeding complications. In the most recent years, the incidence of bleeding complications among patients with ECVD decreased significantly coinciding with the rapid increase of TRI

Impact of body mass index on in-hospital complications in patients undergoing percutaneous coronary intervention in a Japanese real-world multicenter registry.

BACKGROUND:Obesity is associated with advanced cardiovascular disease. However, some studies have reported the "obesity paradox" after percutaneous coronary intervention (PCI). The relationship between body mass index (BMI) and clinical outcomes after PCI has not been thoroughly investigated, especially in Asian populations. METHODS:We studied 10,142 patients who underwent PCI at 15 Japanese hospitals participating in the JCD-KICS registry from September 2008 to April 2013. Patients were divided into four groups according to BMI: underweight, BMI <18.5 (n=462); normal, BMI ≥ 18.5 and <25.0 (n=5,945); overweight, BMI ≥ 25.0 and <30.0 (n=3,100); and obese, BMI ≥ 30.0 (n=635). RESULTS:Patients with a high BMI were significantly younger (p<0.001) and had a higher incidence of coronary risk factors such as hypertension (p<0.001), hyperlipidemia (p<0.001), diabetes mellitus (p<0.001), and current smoking (p<0.001), than those with a low BMI. Importantly, patients in the underweight group had the worst in-hospital outcomes, including overall complications (underweight, normal, overweight, and obese groups: 20.4%, 11.5%, 8.4%, and 10.2%, p<0.001), in-hospital mortality (5.8%, 2.1%, 1.2%, and 2.7%, p<0.001), cardiogenic shock (3.5%, 2.0%, 1.5%, and 1.6%, p=0.018), bleeding complications (10.0%, 4.5%, 2.6%, and 2.8%, p<0.001), and receiving blood transfusion (7.6%, 2.7%, 1.6%, and 1.7%, p<0.001). BMI was inversely associated with bleeding complications after adjustment by multivariate logistic regression analysis (odds ratio, 0.95; 95% confidence interval, 0.92-0.98; p=0.002). In subgroup multivariate analysis of patients without cardiogenic shock, BMI was inversely associated with overall complications (OR, 0.98; 95% CI, 0.95-0.99; p=0.033) and bleeding complications (OR, 0.95; 95% CI, 0.91-0.98; p=0.006). Furthermore, there was a trend that BMI was moderately associated with in-hospital mortality (OR, 0.94; 95% CI, 0.88-1.01; p=0.091). CONCLUSIONS:Lean patients, rather than obese patients are at greater risk for in-hospital complications during and after PCI, particularly for bleeding complications

Impact of coronary dominance on in-hospital outcomes after percutaneous coronary intervention in patients with acute coronary syndrome.

ObjectiveThis study evaluated the manner in which coronary dominance affects in-hospital outcomes of acute coronary syndrome (ACS) patients undergoing percutaneous coronary intervention (PCI).BackgroundPrevious studies have shown that left dominant coronary anatomies are associated with worse prognoses in patients with coronary artery disease.MethodsData were analyzed from 4873 ACS patients undergoing PCI between September 2008 and April 2013 at 14 hospitals participating in the Japanese Cardiovascular Database Registry. The patients were grouped based on diagnostic coronary angiograms performed prior to PCI; those with right- or co-dominant anatomy (RD group) and those with left-dominant anatomy (LD group).ResultsThe average patient age was 67.6±11.8 years and both patient groups had similar ages, coronary risk factors, comorbidities, and prior histories. The numbers of patients presenting with symptoms of heart failure, cardiogenic shock, or cardiopulmonary arrest were significantly higher in the LD group than in the RD group (heart failure: 650 RD patients [14.7%] vs. 87 LD patients [18.8%], P = 0.025; cardiogenic shock: 322 RD patients [7.3%] vs. 48 LD patients [10.3%], P = 0.021; and cardiopulmonary arrest: 197 RD patients [4.5%] vs. 36 LD patients [7.8%], P = 0.003). In-hospital mortality was significantly higher among LD patients than among RD patients (182 RD patients [4.1%] vs. 36 LD patients [7.8%], P = 0.001). Multivariate logistic regression analysis revealed that LD anatomy was an independent predictor for in-hospital mortality (odds ratio, 1.75; 95% confidence interval, 1.06-2.89; P = 0.030).ConclusionAmong ACS patients who underwent PCI, LD patients had significantly worse in-hospital outcomes compared with RD patients, and LD anatomy was an independent predictor of in-hospital mortality

Differences and relationships between weightbearing and non-weightbearing dorsiflexion range of motion in foot and ankle injuries

Abstract Background This study aimed to: (1) identify assessment methods that can detect greater ankle dorsiflexion range of motion (DROM) limitation in the injured limb; (2) determine whether differences in weightbearing measurements exist even in the absence of DROM limitations in the injured limb according to non-weightbearing measurements; and (3) examine associations between DROM in the weightbearing and non-weightbearing positions and compare those between a patient group with foot and ankle injuries and a healthy group. Methods Eighty-two patients with foot and ankle injuries (e.g., fractures, ligament and tendon injuries) and 49 healthy individuals participated in this study. Non-weightbearing DROM was measured under two different conditions: prone position with knee extended and prone position with knee flexed. Weightbearing DROM was measured as the tibia inclination angle (weightbearing angle) and distance between the big toe and wall (weightbearing distance) at maximum dorsiflexion. The effects of side (injured, uninjured) and measurement method on DROM in the patient groups were assessed using two-way repeated-measures ANOVA and t-tests. Pearson correlations between measurements were assessed. In addition, we analyzed whether patients without non-weightbearing DROM limitation (≤ 3 degrees) showed limitations in weightbearing DROM using t-tests with Bonferroni correction. Results DROM in patient groups differed significantly between legs with all measurement methods (all: P < 0.001), with the largest effect size for weightbearing angle (d = 0.95). Patients without non-weightbearing DROM limitation (n = 37) displayed significantly smaller weightbearing angle and weightbearing distance on the injured side than on the uninjured side (P < 0.001 each), with large effect sizes (d = 0.97–1.06). Correlation coefficients between DROM in non-weightbearing and weightbearing positions were very weak (R = 0.17, P = 0.123) to moderate (R = 0.26–0.49, P < 0.05) for the patient group, and moderate to strong for the healthy group (R = 0.51–0.69, P < 0.05). Conclusions DROM limitations due to foot and ankle injuries may be overlooked if measurements are only taken in the non-weightbearing position and should also be measured in the weightbearing position. Furthermore, DROM measurements in non-weightbearing and weightbearing positions may assess different characteristics, particularly in patient group. Level of evidence Level IV, cross-sectional study

Long-term outcomes of periprocedural coronary dissection and perforation for patients undergoing percutaneous coronary intervention in a Japanese multicenter registry

Abstract Long-term outcomes of iatrogenic coronary dissection and perforation in patients undergoing percutaneous coronary intervention (PCI) remains under-investigated. We analyzed 8,721 consecutive patients discharged after PCI between 2008 and 2019 from Keio Cardiovascular (KiCS) PCI multicenter prospective registry in the Tokyo metropolitan area. Significant coronary dissection was defined as persistent contrast medium extravasation or spiral or persistent filling defects with complete distal and impaired flow. The primary outcome was a composite of all-cause death, acute coronary syndrome, heart failure, bleeding, stroke requiring admission, and coronary artery bypass grafting two years after discharge. We used a multivariable Cox hazard regression model to assess the effects of these complications. Among the patients, 68 (0.78%) had significant coronary dissections, and 61 (0.70%) had coronary perforations at the index PCI. Patients with significant coronary dissection had higher rates of the primary endpoint and heart failure than those without (25.0% versus 14.3%, P = 0.02; 10.3% versus 4.2%, P = 0.03); there were no significant differences in the primary outcomes between the patients with and without coronary perforation (i.e., primary outcome: 8.2% versus 14.5%, P = 0.23) at the two-year follow-up. After adjustments, patients with coronary dissection had a significantly higher rate of the primary endpoint than those without (HR 1.70, 95% CI 1.02–2.84; P = 0.04), but there was no significant difference in the primary endpoint between the patients with and without coronary perforation (HR 0.51, 95% CI 0.21–1.23; P = 0.13). For patients undergoing PCI, significant coronary dissection was associated with poor long-term outcomes, including heart failure readmission

Procedural Volume and Outcomes After Percutaneous Coronary Intervention for Unprotected Left Main Coronary Artery Disease-Report From the National Clinical Data (J-PCI Registry)

Background There is a limited evidence base to support the volume-outcome relationship in patients undergoing percutaneous coronary intervention (PCI) for unprotected left main coronary artery disease (UPLMD). This study aimed to evaluate the relationship between institutional and operator volume and in-hospital outcomes in patients undergoing PCI for unprotected left main coronary artery disease. Methods and Results We analyzed characteristics and clinical outcomes of 24 320 patients undergoing PCI for unprotected left main coronary artery disease at 1102 hospitals by 7244 operators using data from the Japanese nationwide J-PCI Registry (National PCI Data Registry) between January 2014 and December 2017. We classified institutions and operators into quartiles based on the mean annual volume of PCI. A generalized linear mixed-effects model was used to evaluate the association between institutional and operator PCI volume and in-hospital outcomes. Among the 24 320 patients, 4027 (16.6%), 6147 (25.3%), and 14 146 (58.2%) presented with ST-segment-elevation myocardial infarction, non-ST-segment-elevation acute coronary syndrome, and stable ischemic heart disease; their crude in-hospital mortality was 15%, 3.1%, and 0.3%, respectively. Compared with patients in the lowest quartile of institutional volume (1-216 PCIs/y), the adjusted odds ratio of in-hospital death in patients in the second (217-323 PCIs/y), third (324-487 PCIs/y), and fourth (488-3015 PCIs/y) quartile of institutional volume was 0.75 (95% CI, 0.51-1.10; P=0.14), 0.87 (95% CI, 0.57-1.34; P=0.54), and 0.51 (95% CI, 0.30-0.86; P=0.01), respectively. These findings were consistent in rates of in-hospital death or any complication. Conversely, operator PCI volume was not significantly associated with in-hospital outcomes. Conclusions Institutional rather than operator-based PCI volume was associated with better in-hospital outcomes in patients undergoing PCI for unprotected left main coronary artery disease

Effects of body habitus on contrast-induced acute kidney injury after percutaneous coronary intervention.

BACKGROUND:Limiting the contrast volume to creatinine clearance (V/CrCl) ratio is crucial for preventing contrast-induced acute kidney injury (CI-AKI) after percutaneous coronary intervention (PCI). However, the incidence of CI-AKI and the distribution of V/CrCl ratios may vary according to patient body habitus. OBJECTIVE:We aimed to identify the clinical factors predicting CI-AKI in patients with different body mass indexes (BMIs). METHODS:We evaluated 8782 consecutive patients undergoing PCI and who were registered in a large Japanese database. CI-AKI was defined as an absolute serum creatinine increase of 0.3 mg/dL or a relative increase of 50%. The effect of the V/CrCl ratio relative to CI-AKI incidence was evaluated within the low- (≤25 kg/m2) and high- (>25 kg/m2) BMI groups, with a V/CrCl ratio > 3 considered to be a risk factor for CI-AKI. RESULTS:A V/CrCl ratio > 3 was predictive of CI-AKI, regardless of BMI (low-BMI group: odds ratio [OR], 1.77 [1.42-2.21]; P 3 (37.3% vs. 20.4%) were predominant in the low-BMI group. Indeed, low BMI was a significant predictor of a V/CrCl ratio > 3 (OR per unit decrease in BMI, 1.08 [1.05-1.10]; P 3 was strongly associated with the occurrence of CI-AKI. Importantly, we also identified a tendency for physicians to use higher V/CrCl ratios in lean patients. Thus, recognizing this trend may provide a therapeutic target for reducing the incidence of CI-AKI

Impact of catheter-induced iatrogenic coronary artery dissection with or without postprocedural flow impairment: A report from a Japanese multicenter percutaneous coronary intervention registry.

Despite the ever-increasing complexity of percutaneous coronary intervention (PCI), the incidence, predictors, and in-hospital outcomes of catheter-induced coronary artery dissection (CICAD) is not well defined. In addition, there are little data on whether persistent coronary flow impairment after CICAD will affect clinical outcomes. We evaluated 17,225 patients from 15 participating hospitals within the Japanese PCI registry from January 2008 to March 2016. Associations between CICAD and in-hospital adverse cardiovascular events were evaluated using multivariate logistic regression. Outcomes of patients with CICAD with or without postprocedural flow impairment (TIMI flow ≤ 2 or 3, respectively) were analyzed. The population was predominantly male (79.4%; mean age, 68.2 ± 11.0 years); 35.6% underwent PCI for complex lesions (eg. chronic total occlusion or a bifurcation lesion.). CICAD occurred in 185 (1.1%), and its incidence gradually decreased (p < 0.001 for trend); postprocedural flow impairment was observed in 43 (23.2%). Female sex, complex PCI, and target lesion in proximal vessel were independent predictors (odds ratio [OR], 2.18; 95% confidence interval [CI], 1.53-3.10; OR, 2.19; 95% CI, 1.58-3.04; and OR, 1.55; 95% CI, 1.06-2.28, respectively). CICAD was associated with an increased risk of in-hospital adverse events (composite of new-onset cardiogenic shock and new-onset heart failure) regardless of postprocedural flow impairment (OR, 10.9; 95% CI, 5.30-22.6 and OR, 2.27; 95% CI, 1.20-4.27, respectively for flow-impaired and flow-recovered CICAD). In conclusion, CICAD occurred in roughly 1% of PCI cases; female sex, complex PCI, and proximal lesion were its independent risk factors. CICAD was associated with adverse in-hospital cardiovascular events regardless of final flow status. Our data implied that the appropriate selection of PCI was necessary for women with complex lesions