Characteristics and outcomes of patients with no standard modifiable risk factors undergoing primary revascularization for acute myocardial infarction: Insights from the nationwide Japanese percutaneous coronary intervention registry.

BACKGROUND: Identification of and therapeutic approaches to standard modifiable risk factors (SMuRFs), including hypertension, diabetes, dyslipidemia, and smoking, have led to improved survival of patients at risk for coronary events. However, recent studies have indicated that a significant proportion of patients with acute myocardial infarction (AMI) have no SMuRFs. We aimed to assess in-hospital outcomes and the prevalence of these patients using the Japanese nationwide percutaneous coronary intervention (J-PCI) registry. METHODS: The J-PCI is a procedure-based registration program in Japan. A total of 115,437 PCI procedures were performed on patients with AMI between January 2019 and December 2020. The participants were divided into 2 groups: those with at least 1 SMuRF and those without any SMuRFs. The primary outcome was in-hospital mortality. RESULTS: Of the 115,437 patients with AMI, 1,777 (1.6%) had no SMuRFs. Patients without SMuRFs were older; more likely to have left main disease; and more likely to present with heart failure, cardiogenic shock, and cardiac arrest than those with SMuRFs, resulting in higher rates of mechanical circulatory support use and impaired post-PCI coronary blood flow. In-hospital mortality was significantly higher in patients without SMuRFs than in those with SMuRFs (18.3% vs 5.3%, P < .001), irrespective of the presence or absence of ST-segment elevation. CONCLUSIONS: In Japan, where annual health checks are mandated under universal health care coverage, the vast majority of patients with AMI undergoing PCI have SMuRFs. However, although small in number, patients without SMuRFs are more likely to present with life-threatening conditions and have worse in-hospital survival.

Transcatheter aortic valve replacement-related aortic dissection: A clinical case series.

OBJECTIVES: We review our experience with 13 periprocedural aortic dissection (AD) cases caused by transcatheter aortic valve replacement (TAVR). BACKGROUND: AD is a potentially lethal complication of TAVR; however, only sporadic case reports have been published to date. METHODS: Among 1335 consecutive patients who underwent TAVR in 2013-2021, we retrospectively extracted 13 patients (1.0%) with TAVR-related AD (Stanford type A in 6 [46%], type B in 7 [54%]). AD was defined as a new-onset dissected layer of the aortic wall and diagnosed by aortography, computed tomography, or transesophageal echocardiography. RESULTS: Five of the six type A AD cases (83%) were detected during TAVR versus only one of the seven type B AD cases (14%). Four of the seven type B AD cases (57%) were asymptomatic and incidentally detected on computed tomography. The presumed causes of AD were injury by the delivery sheath (39%), delivery catheter (23%), valve implantation (15%), stent edge (15%), and pre-dilation balloon (8%). Complicated AD occurred in only one patient (8%). Considering the patient's age and prohibitive surgical risk, all patients were treated conservatively and free of any aortic-related deaths or interventions during a follow-up of 1087 days. CONCLUSIONS: TAVR-related AD is a rare but life-threatening condition that may be underdiagnosed. Its optimal therapy remains unclear, and conservative management might be an option for selected patients. Further studies are needed to elucidate the incidence, risk factors, effective screening, optimal therapy, and outcomes of TAVR-related AD.

Intracardiac Echocardiography Guidance for Percutaneous Transcatheter Closure of Atrial Septal Defects　- Nationwide Registry Data Analysis.

BACKGROUND: Transesophageal echocardiography (TEE) has been used for percutaneous atrial septal defect (ASD) closure, with intracardiac echocardiography (ICE) guidance recently being introduced.Methods and Results: The Japanese Structural Heart Disease Registry was established by the Japanese Association of Cardiovascular Intervention and Therapeutics. This study analyzed data from the Registry for 2,859 consecutive cases undergoing percutaneous ASD closure between January 2015 and December 2020. ASD closure was performed under ICE guidance (n=519; 18.2%), TEE guidance (n=1,428; 49.9%), or TEE plus ICE guidance ("Both"; n=900 cases; 31.5%). The success rates were similar in the TEE, ICE, and both groups (99.0%, 99.2%, vs. 98.0%, respectively; P=0.054), as were complication rates (1.2%, 0.5%, vs. 2.1%, respectively; P=0.24). In the TEE and Both groups, 92.4% and 79.6% of patients required general anesthesia, compared with only 2.9% of patients in the ICE group (P<0.001). Fluoroscopic time was longer in the ICE and Both groups than in the TEE group (median [interquartile range] 19 [14-28] and 21 [13-30] vs. 12 [8-19] min, respectively; P<0.001). Rim deficiency and larger defect diameter were inversely related, whereas hospital volume was positively related to ICE guidance. CONCLUSIONS: Percutaneous transcatheter ASD closure was as feasible under ICE as under TEE guidance. ICE guidance is used for less challenging cases in high-volume centers in Japan.

Impact of periprocedural bleeding on mid-term outcome in nonagenarians who underwent transcatheter aortic valve implantation: insights from LAPLACE registry.

Data from several recent studies have demonstrated the safety and efficacy of transcatheter aortic valve implantation (TAVI) for severe aortic stenosis (AS) even in nonagenarians. However, the impact of periprocedural bleeding following TAVI on their outcome remains unclear. In the aLliAnce for exPloring cLinical prospects of AortiC valvE disease (LAPLACE) registry, we compared outcomes between the bleeding and no-bleeding groups among 1953 patients < 90 years old (mean age, 83.0 ± 4.6 years old) and 316 nonagenarians (mean age, 91.7 ± 1.9 years old) who underwent TAVI with a median follow-up period of 628 days. The group with any periprocedural bleeding showed a higher 30-day mortality than the no-bleeding group in patients < 90 years old (3.3% vs. 0.5%, p = 0.001) and nonagenarians (7.9% vs. 0.7%, p = 0.001). In patients < 90 years old, severe periprocedural bleeding (n = 85) was associated with a higher mid-term all-cause mortality rate than no severe bleeding (n = 1,868), even after adjusting for covariates (hazard ratio [HR], 1.994; 95% confidence interval [CI] 1.287-2.937; p = 0.002). On the other hand, in nonagenarians, any periprocedural bleeding (n = 38) was associated with a higher mid-term cardiovascular (CV) mortality rate (21.1% vs. 4.3%, log-rank p = 0.014) than no bleeding (n = 278), even after adjusting for covariates (HR, 3.104; 95% CI 1.140-8.449; p = 0.027). In conclusion, any periprocedural bleeding after TAVI was associated with mid-term CV mortality in nonagenarians, whereas severe bleeding was associated with mid-term all-cause mortality in patients < 90 years old.

High-risk imaging characteristics in left ventricular apex for the life-threatening arrhythmic events in Japanese hypertrophic cardiomyopathy patients.

Left ventricular (LV) apical aneurysm is known to be associated with the life-threatening arrhythmic events in hypertrophic cardiomyopathy (HCM). However, the current 2014 ESC guideline has not included apical aneurysm as a major risk factor for sudden cardiac death and 2018 JCS guideline includes it only as a modulator, while it has been included as a new major risk marker in 2020 AHA/ACC guideline. Therefore, we sought to identify high-risk imaging characteristics in LV apex which is associated with a higher occurrence of ventricular tachycardia/fibrillation (VT/VF). In 99 consecutive Japanese HCM patients (median age, 65 years; 59 males) undergoing implantable cardioverter-defibrillator (ICD) implantation for primary prevention following cardiac magnetic resonance including late gadolinium enhancement (LGE), the occurrence of appropriate ICD interventions for VT/VF was evaluated for 6.2 (median) years after ICD implantation. Overall, appropriate ICD interventions occurred in 43% with annual rates of 7.0% for appropriate interventions. Kaplan-Meier analysis demonstrated that the presence of LV apical aneurysm was significantly associated with a higher occurrence of appropriate interventions (annual rates 18.9% vs. 6.4%, P = 0.013). Similarly, patients with high LV mid-to-apex pressure gradient (annual rates 14.9% vs. 6.2%, P = 0.022) and presence of apical LGE (annual rates 10.9% vs. 4.0%, P = 0.001) experienced appropriate interventions more frequently. An aneurysm, high-pressure gradient, and LGE in an apex are associated with VT/VF. These characteristics in apex should be kept in mind when implanting ICD in Japanese HCM patients as a primary prevention.

Combination Use of Inoue-Balloon and Self-Expandable Transcatheter Valves in Managing Aortic Stenosis Not Amenable to Balloon-Expandable Valves.

Data on the combined use of aortic Inoue-Balloon catheter and self-expandable transcatheter valve for patients undergoing transcatheter aortic valve replacement (TAVR) are lacking. This study aimed to assess the feasibility and safety of this combination, particularly in patients who cannot be safely managed with balloon-expandable valves.Between 2018 and 2021, 140 consecutive patients who had Inoue-Balloon catheters with self-expandable valves were retrospectively examined. Self-expandable transcatheter valves were deployed using the heart team approach in patients with calcification on the left ventricular outflow tract, which could not be safely addressed with the current-generation balloon-expandable valves.The 20- and 22 mm Inoue-Balloon catheters were used with the 26- and 29 mm Evolut valves, respectively. According to the Valve Academic Research Consortium-2 criteria, the procedural success rate was 95.0%, with an early safety at 30 days rate of 6.5%. A total of 27 patients required post-dilation with the same Inoue-Balloon catheter used for pre-dilation after adjustment to appropriate sizes. Post-dilation, with balloon size adjusted to be 1.4 ± 0.9 mm larger than that in pre-dilation, was effective in 19 out of 27 patients (70.3%) for decreasing paravalvular leak after transcatheter valve deployment. The procedural complication rates between patients with and without post-dilation were not different.The combined use of the size-adjustable Inoue-Balloon catheter and self-expandable valve is safe, particularly in patients who cannot be safely managed with balloon-expandable valves. However, further studies are warranted to elucidate concerns regarding the durability of self-expandable transcatheter valves after post-dilation using the Inoue-Balloon catheter.

Impaired Left Atrial Function in Patients with Atrial Septal Defect and History of Atrial Fibrillation.

In patients with atrial septal defect (ASD), atrial left-to-right shunting causes left atrial (LA) remodeling and dysfunction, leading to atrial fibrillation (AF). In adults with ASD and concomitant AF, LA function should be evaluated after ASD closure plus AF radiofrequency catheter ablation (RFCA).This multicenter retrospective cohort study included patients who underwent transcatheter ASD closure at one of the four leading hospitals. Patients with a history of AF also underwent preceding RFCA. The association between AF history and LA ejection fraction (EF) (indicating LA global function) at 6-12 months following ASD closure was evaluated. To account for differences in baseline characteristics between patients with and without a history of AF, we conducted the following statistical methods: (1) multivariate regression analysis in the prepropensity score (PS)-matched cohort and (2) univariate comparisons in the PS-matched cohort.Overall, this study included 231 patients (30 with AF history, 201 without). Multiple regression analysis showed that AF history was independently associated with impaired LAEF (ß = -10.425, P < 0.001, model created prior to propensity matching). A one-to-one PS matching (25 pairs) showed that the LAEF at 6-12 months following ASD closure was significantly impaired in patients with ASD and AF history compared to that in patients without history of AF (median LAEF, 37.5% (interquartile range [IQR] 29.4%-48.5%) versus 52.3 [IQR 50.0%-56.6%]; P < 0.001).LA function was impaired in patients with ASD and a history of AF at 6-12 months after successful transcatheter ASD closure and on maintenance of sinus rhythm by RFCA.

Prevalence, Characteristics, and Impact of Frailty in Patients with Functional Tricuspid Regurgitation.

Little is known as regards frailty in patients with functional tricuspid regurgitation (FTR). Thus, in this study, we aimed to investigate the prevalence, characteristics, and impact of frailty on patients with severe FTR.This prospective study included 110 consecutive patients with severe FTR who were assessed via transthoracic echocardiography at an outpatient clinic. Patients were dichotomized using short physical performance battery (SPPB). To better understand the whole picture of frailty in patients with FTR, other frailty scales were also assessed (frailty checklist, clinical frailty scale, gait speed, and Columbia frailty scale). The primary endpoint was the combination of all-cause mortality and heart failure hospitalization.According to each definition of frailty, 28%-46% were identified to be frail. Those with SPPB score of < 9 were older, had greater New York Heart Association (NYHA) functional classification, and had lower albumin level and estimated glomerular filtration rate compared with those with SPPB score of ≥ 9. They also have smaller tricuspid valve coaptation depth and worse right ventricular fractional area change (RV-FAC) than those with SPPB score of ≥ 9 despite having similar TR severity. The primary endpoint at 1 year was noted in 31% of patients. The SPPB score has excellent discriminatory performance for predicting the primary endpoint (area under the curve 0.82, 95% confidence interval [CI] 0.76-0.91) in receiver operating characteristic analysis and was independently associated with the primary endpoint after adjustment in multivariate analysis (adjusted hazard ratio 0.81, 95% CI, 0.73-0.90; P < 0.001).Frailty has been widely prevalent in the elderly patient population with FTR; in fact, it has been determined to be strong parameter for poor outcomes.

Monotherapy With Prasugrel After Dual-Antiplatelet Therapy for Japanese Percutaneous Coronary Intervention Patients With High Bleeding Risk　- A Prospective Cohort Study (PENDULUM mono Study).

BACKGROUND: The risks of bleeding and cardiovascular events in high bleeding risk (HBR) Japanese patients undergoing percutaneous coronary intervention (PCI) while receiving single-antiplatelet therapy (SAPT) remains unknown. We aimed to evaluate the frequency of bleeding and cardiovascular events associated with prasugrel monotherapy after short-term dual-antiplatelet therapy (DAPT) in Japanese HBR patients after PCI.Methods and Results:The PENDULUM mono study was a multicenter, non-interventional, prospective registry (n=1,173). The primary endpoint was the cumulative incidence of clinically relevant bleeding (CRB; Bleeding Academic Research Consortium types 2, 3, and 5) from 1 to 12 months after PCI. Secondary endpoints included major adverse cardiac and cerebrovascular events (MACCE). The proportion of patients who received prasugrel monotherapy at 12 months after PCI was 79.7%, and no cases of stent thrombosis were observed among these patients. The cumulative incidence of CRB was 3.2% from 1 to 12 months after PCI; that of MACCE was 3.8%. Severe anemia, chronic kidney disease, oral anticoagulant use at discharge, and heart failure were significantly associated with CRB. CONCLUSIONS: Among HBR patients undergoing PCI who were not suitable for concomitant aspirin and were scheduled for prasugrel monotherapy, most patients were on prasugrel monotherapy after DAPT. Cumulative incidences of CRB and MACCE after periprocedural period were 3.2% and 3.8%, respectively, and no cases of stent thrombosis were reported. SAPT might be a suitable alternative to DAPT.

Prolonged Intensive Care Unit Stay Following Transcatheter Aortic Valve Replacement.

PURPOSE: Postoperative intensive care unit (ICU) stay after cardiac surgeries has been extensively studied, but little attention has been given to ICU stay following transcatheter aortic valve replacement (TAVR). This study examined ICU stay after TAVR. METHODS: Two hundred and forty-five patients who underwent TAVR between April 2010 and October 2016 were studied retrospectively. We investigated the status of ICU stay, the predictors of prolonged ICU stay (PICUS), and its impact on short- and long-term outcomes. Prolonged ICU stay was defined as post-TAVR ICU stay longer than 2 days (day of TAVR + 1 day). RESULTS: Length of ICU stay was 2.6 ± 4.9 days, and PICUS was identified in 14.7% of the patients. The predominant reason for PICUS was congestive heart failure or circulatory failure (41.7%). Pulmonary dysfunction and nontransfemoral approach were independent predictors of PICUS (pulmonary dysfunction: odds ratio = 2.64, 95% confidence interval [CI]: 1.05-7.35; nontransfemoral approach: odds ratio = 2.81, 95% CI: 1.15-6.89). Prolonged ICU stay was associated with higher rate of 30-day combined end point (PICUS vs non-PICUS: 44.4% vs 3.3%, P < .0001), longer postoperative hospital stay (49.9 ± 141.9 days vs 12.0 ± 6.0 days, P < .0001), and lower rate of discharge home (77.8% vs 95.2%, P = .0002). Patients with PICUS had worse long-term survival (P < .0001), and PICUS was a predictor of mortality (hazard ratio: 4.21, 95% CI: 2.09-8.22). CONCLUSION: Prolonged ICU stay following TAVR was found in 14.7%, and pulmonary dysfunction and nontransfemoral approach were associated with PICUS. Short- and long-term prognoses were worse in patients with PICUS than those without.

Transcatheter aortic valve implantation-related futility: prevalence, predictors, and clinical risk model.

Futility denotes failure to achieve the projected outcome. We investigated the prevalence, predictors, and clinical risk model of transcatheter aortic valve implantation (TAVI)-related futility. We included 464 consecutive patients undergoing TAVI from 2010 to 2017. Futility was defined as death and/or hospitalization for heart failure (HFH) within 1 year after TAVI. Of 464 patients (mean age: 84.4 years), 69% were females (EuroSCOREII: 6.3%; Society of Thoracic Surgeons [STS] score: 6.9%). Forty-six patients (9.9%) experienced TAVI-related futility, and 36 of 46 patients (69.6%) died within 1 year due to cardiac (37.5%) and non-cardiac (62.5%) causes. Previous HFH (hazard ratio [HR], 2.20; 95% confidence interval [CI]: 1.13-4.35, p = 0.020), chronic obstructive pulmonary disease (COPD) (HR, 3.39; 95% CI: 1.12-8.42, p = 0.033), and moderate/severe mitral or tricuspid regurgitation (HR, 2.98; 95% CI: 1.32-6.27, p = 0.010) were independent predictors of futility. With 1 point assigned to each predictor (total 0 point, futility low-risk; total 1 point, futility intermediate-risk; total 2-3 points, futility high-risk), the futility risk model clearly stratified individual futility risk into three groups (the freedom from futility at 1 year: 96.2%, 82.1%, and 67.9% each). Our futility risk model presented better discrimination than EuroSCOREII, and STS score (c-statistic: 0.73 vs. 0.68 vs. 0.67). Medical futility was recognized in 9.9% of patients undergoing TAVI. Previous HFH, COPD, and concomitant atrioventricular regurgitation were associated with futility. The risk model derived from three predictors showed good performance in predicting futility risk.

Additive prognostic significance of ejection fraction for ESC risk model in hypertrophic cardiomyopathy patients.

The European Society of Cardiology (ESC) clinical risk model is reported in predicting sudden death of hypertrophic cardiomyopathy (HCM). We examined the validity of this model and investigated the significance of ejection fraction (EF) in predicting the prognosis using ESC risk model in HCM patients. 305 HCM patients (198 males) were followed (median follow-up 4.8 years) for life-threatening arrhythmic events (sudden death, aborted sudden death, sustained VT/VF, appropriate ICD intervention for VT/VF) and were divided using ESC risk model into low- (Group L), intermediate- (Group I) and high- (Group H) risk groups. There was a significant difference in the events rate among the 3 groups (L, 0.9%/year; I, 3.9%/year; H, 6.8%/year; log-rank p < 0.001) in all study patients. Reduced EF (<50%) was identified in 27 (8.9%) cases. There was a significant difference in the events rate among the 3 groups in patients with reduced EF (L, 2.4%/year; I, 4.9%/year; H, 16.1%/year; log-rank p = 0.025). There was a significant difference in the events rate among 2 groups in patients stratified as Group H (preserved EF, 3.1%/year vs. reduced EF, 16.1%/year; log-rank p = 0.041). ESC risk model precisely predicts life-threatening events in patients with HCM. Adding EF to ESC risk model are useful for further risk stratification of life-threatening arrhythmic events.

Usefulness of the Transcatheter Aortic Valve Replacement Risk Score to Determine Mid-Term Outcomes.

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.

Clinical features of potential after-effects of percutaneous coronary intervention in the treatment of silent myocardial ischemia.

Clinical predictors for later adverse cardiovascular events in patients undergoing percutaneous coronary intervention (PCI) for silent myocardial ischemia remain undetermined. We investigated clinical features leading to later adverse cardiovascular events in patients who underwent PCI for silent myocardial ischemia. Of a total of 294 consecutive patients with a diagnosis of silent myocardial ischemia who successfully underwent contemporary PCI in our institute between January 2013 and December 2014, an initial event of any of all-cause death, hospitalized heart failure, acute coronary syndromes, and target vessel revascularization were identified as later adverse cardiovascular events and evaluated an association of them with baseline clinical characteristics. Silent myocardial ischemia was defined by an assessment of either electrocardiogram, myocardial perfusion imaging, coronary angiogram, or coronary fractional flow reserve. During a median follow-up of 565 days (interquartile range 361-816), later adverse cardiovascular events were identified in 38 patients (13%) consisting of 6 deaths, 5 hospitalized heart failures, 2 acute coronary syndromes, and 25 target vessel revascularizations. A presence of chronic kidney disease and/or insulin-treated diabetes mellitus, but not other clinical features, was strongly associated with later adverse cardiovascular events (hazard ratio 8.22; 95% confidential interval 2.95-29.25, P < 0.0001). Those events were increased in accordance with advanced stages of chronic kidney disease (P = 0.0003). A presence of chronic kidney disease and/or insulin-treated diabetes mellitus may lead the potential after-effects of PCI in the treatment of silent myocardial ischemia.

Effect of 1-Month Dual Antiplatelet Therapy Followed by Clopidogrel vs 12-Month Dual Antiplatelet Therapy on Cardiovascular and Bleeding Events in Patients Receiving PCI: The STOPDAPT-2 Randomized Clinical Trial.

Importance: Very short mandatory dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) with a drug-eluting stent may be an attractive option. Objective: To test the hypothesis of noninferiority of 1 month of DAPT compared with standard 12 months of DAPT for a composite end point of cardiovascular and bleeding events. Design, Setting, and Participants: Multicenter, open-label, randomized clinical trial enrolling 3045 patients who underwent PCI at 90 hospitals in Japan from December 2015 through December 2017. Final 1-year clinical follow-up was completed in January 2019. Interventions: Patients were randomized either to 1 month of DAPT followed by clopidogrel monotherapy (n=1523) or to 12 months of DAPT with aspirin and clopidogrel (n=1522). Main Outcomes and Measures: The primary end point was a composite of cardiovascular death, myocardial infarction (MI), ischemic or hemorrhagic stroke, definite stent thrombosis, or major or minor bleeding at 12 months, with a relative noninferiority margin of 50%. The major secondary cardiovascular end point was a composite of cardiovascular death, MI, ischemic or hemorrhagic stroke, or definite stent thrombosis and the major secondary bleeding end point was major or minor bleeding. Results: Among 3045 patients randomized, 36 withdrew consent; of 3009 remaining, 2974 (99%) completed the trial. One-month DAPT was both noninferior and superior to 12-month DAPT for the primary end point, occurring in 2.36% with 1-month DAPT and 3.70% with 12-month DAPT (absolute difference, -1.34% [95% CI, -2.57% to -0.11%]; hazard ratio [HR], 0.64 [95% CI, 0.42-0.98]), meeting criteria for noninferiority (P < .001) and for superiority (P = .04). The major secondary cardiovascular end point occurred in 1.96% with 1-month DAPT and 2.51% with 12-month DAPT (absolute difference, -0.55% [95% CI, -1.62% to 0.52%]; HR, 0.79 [95% CI, 0.49-1.29]), meeting criteria for noninferiority (P = .005) but not for superiority (P = .34). The major secondary bleeding end point occurred in 0.41% with 1-month DAPT and 1.54% with 12-month DAPT (absolute difference, -1.13% [95% CI, -1.84% to -0.42%]; HR, 0.26 [95% CI, 0.11-0.64]; P = .004 for superiority). Conclusions and Relevance: Among patients undergoing PCI, 1 month of DAPT followed by clopidogrel monotherapy, compared with 12 months of DAPT with aspirin and clopidogrel, resulted in a significantly lower rate of a composite of cardiovascular and bleeding events, meeting criteria for both noninferiority and superiority. These findings suggest that a shorter duration of DAPT may provide benefit, although given study limitations, additional research is needed in other populations. Trial Registration: ClinicalTrials.gov Identifier: NCT02619760.

Outcomes of Transcatheter Aortic Valve Implantation in Patients with Cirrhosis.

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.

High Signal Intensity on T2-Weighted Cardiovascular Magnetic Resonance Imaging Predicts Life-Threatening Arrhythmic Events in Hypertrophic Cardiomyopathy Patients.

BACKGROUND: The prognostic value of high signal intensity on T2-weighted cardiovascular magnetic resonance imaging (T2 high signal) in hypertrophic cardiomyopathy (HCM) patients in a single-center cohort was investigated.Methods and Results:A total of 237 HCM patients (median age, 62 years; 143 male) underwent T2-weighted, cine and late gadolinium enhancement (LGE) imaging, and were followed (median duration, 3.4 years) for life-threatening arrhythmic events. The clinical and magnetic resonance imaging characteristics were extracted, and predictors of life-threatening arrhythmic events were assessed on multivariate analysis. LGE was present in 180 patients (75.9%). Median LGE score was 3 in a left ventricle 17-segment model. T2 high signal was present in 49 patients (20.7%). The annual events rate was significantly higher in patients with extensive LGE (score ≥4) than in those without (3.0%/year vs. 0.5%/year, P=0.011). On multivariate analysis, extensive LGE (hazard ratio, 5.650; 95% CI: 1.263-25.000, P=0.024) as an independent predictor for life-threatening arrhythmic events. In patients with extensive LGE, the annual events rate was significantly higher in patients with T2 high signal than in those without (5.8%/year vs. 0.9%/year, P=0.008). CONCLUSIONS: Extensive LGE was an independent predictor of life-threatening arrhythmic events in HCM patients. Furthermore, T2 high signal is useful for the risk stratification of serious arrhythmic events in patients with extensive LGE.

Outcomes of patients requiring extracorporeal membrane oxygenation in transcatheter aortic valve implantation: a clinical case series.

Transcatheter aortic valve implantation (TAVI) has been established as a low-invasive therapy for aortic stenosis, but circulatory collapse necessitating mechanical circulatory support could occur during TAVI due to procedure itself or procedural complications. The purpose of this study is to describe the outcomes of patients requiring extracorporeal membrane oxygenation (ECMO) in TAVI. Among 384 consecutive patients undergoing TAVI from April 2010 to July 2017 in Sakakibara Heart Institute, we evaluated seven patients (1.8%) who required ECMO during procedure. The definitions of outcome were derived from Valve Academic Research Consortium-2 criteria. The indication of ECMO included bridge to emergent surgery due to mechanical complication (n = 3) [aortic root rupture (n = 2), and left-ventricle rupture (n = 1); emergent use], bridge to recovery from cardiac stunning (n = 3; emergent use), and circulatory support for cardiogenic shock (n = 1; prophylactic use). All patients were cannulated from femoral artery and vein, and there was no ECMO-related complication. Six out of seven patients were weaned from ECMO during the TAVI procedure, whereas the other patient with annulus rupture died the following day after TAVI. Five patients survived to discharge [postoperative hospital stay: 27.6 ± 24.3 (23) days]. During mean follow-up of 253 days, a total of three patients died due to annulus rupture, refractory heart failure, and pneumonia, respectively. ECMO is effective and a safe mechanical support device during TAVI. The mid-term outcomes of patients who needed ECMO were unfavorable. Further evolution of transcatheter heart valve is essential, and prophylactic ECMO may contribute to better prognosis in selected patients.

Prognostic value of cardiovascular magnetic resonance imaging for life-threatening arrhythmia detected by implantable cardioverter-defibrillator in Japanese patients with hypertrophic cardiomyopathy.

Implantable cardioverter-defibrillator (ICD) is effective to prevent sudden death in HCM patients. We reviewed ICD records to analyze the relation between life-threatening arrhythmia and late gadolinium enhancement (LGE) on cardiovascular magnetic resonance (CMR) in Japanese hypertrophic cardiomyopathy (HCM) patients. In 102 consecutive patients (median age 63 years, 63 males) implanted with an ICD after CMR with gadolinium enhancement (median follow-up 2.8 years), the outcome of life-threatening arrhythmic events (appropriate ICD interventions for ventricular tachycardia or ventricular fibrillation) was examined. Appropriate interventions rate were 10.3% per year for secondary prevention and 7.4% per year for primary prevention. The annualized ICD-related complication rate was 3.7%. 43/91 patients (47%) implanted ICD for primary prevention had maximum wall thickness ≥20 mm plus LGE in ≥4 of 17 left ventricular segments (cut-off value obtained from ROC curve); the appropriate ICD intervention rate was significantly higher in this group than in other patients group (annualized event rate, 11.1 vs. 4.6%; log-rank P = 0.038). A combination of myocardial hypertrophy and LGE is a useful outcome predictive factor for life-threatening ventricular arrhythmia in Japanese HCM patients.