Comparative Data of Procedural and Midterm Outcomes in Patients Who Underwent Percutaneous Left Atrial Appendage Closure Between the WATCHMAN FLX and WATCHMAN 2.5 Devices　- Insight From the OCEAN-LAAC Registry.

BACKGROUND: Limited data are available regarding clinical outcomes after percutaneous left atrial appendage closure using WATCHMAN FLX (WM-FLX) and WATCHMAN-2.5 (WM2.5) devices in Asian patients.Methods and Results: Data of 1,464 consecutive patients (WM-FLX, n=909; WM2.5, n=555) were extracted from a Japanese multicenter registry, and clinical data were compared between the 2 groups. No in-hospital deaths, periprocedural stroke, or device embolization occurred. Procedural success was significantly higher in the WM-FLX than WM2.5 group (95.8% vs. 91.9%; P=0.002) owing to the lower incidence of periprocedural pericardial effusion (0.55% vs. 1.8%; P=0.021). No significant differences in all-cause death, postprocedural stroke, and device-related thrombus were observed between the 2 groups. However, the cumulative bleeding rate at 1 year was substantially lower in the WM-FLX group (7.8% vs. 16.4%; P<0.001). Landmark analysis of bleeding events highlighted lower bleeding rates in the WM-FLX than WM2.5 group within the first 6 months (6.4% vs. 14.8%; P<0.001), with comparable bleeding rates over the 6- to 12-month period (1.5% vs. 3.2%, respectively; P=0.065). CONCLUSIONS: This study demonstrated higher early safety and lower 1-year bleeding rates in the WM-FLX than WM2.5 group. The lower bleeding events with WM-FLX are likely due to multiple factors other than purely difference in devices, such as postprocedural drug regimen.

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.

Improved prediction of sudden cardiac death in patients with heart failure through digital processing of electrocardiography.

AIMS: Available predictive models for sudden cardiac death (SCD) in heart failure (HF) patients remain suboptimal. We assessed whether the electrocardiography (ECG)-based artificial intelligence (AI) could better predict SCD, and also whether the combination of the ECG-AI index and conventional predictors of SCD would improve the SCD stratification among HF patients. METHODS AND RESULTS: In a prospective observational study, 4 tertiary care hospitals in Tokyo enrolled 2559 patients hospitalized for HF who were successfully discharged after acute decompensation. The ECG data during the index hospitalization were extracted from the hospitals' electronic medical record systems. The association of the ECG-AI index and SCD was evaluated with adjustment for left ventricular ejection fraction (LVEF), New York Heart Association (NYHA) class, and competing risk of non-SCD. The ECG-AI index plus classical predictive guidelines (i.e. LVEF ≤35%, NYHA Class II and III) significantly improved the discriminative value of SCD [receiver operating characteristic area under the curve (ROC-AUC), 0.66 vs. 0.59; P = 0.017; Delong's test] with good calibration (P = 0.11; Hosmer-Lemeshow test) and improved net reclassification [36%; 95% confidence interval (CI), 9-64%; P = 0.009]. The Fine-Gray model considering the competing risk of non-SCD demonstrated that the ECG-AI index was independently associated with SCD (adjusted sub-distributional hazard ratio, 1.25; 95% CI, 1.04-1.49; P = 0.015). An increased proportional risk of SCD vs. non-SCD with an increasing ECG-AI index was also observed (low, 16.7%; intermediate, 18.5%; high, 28.7%; P for trend = 0.023). Similar findings were observed in patients aged ≤75 years with a non-ischaemic aetiology and an LVEF of >35%. CONCLUSION: To improve risk stratification of SCD, ECG-based AI may provide additional values in the management of patients with HF.

Deep Learning Models for Predicting Left Heart Abnormalities From Single-Lead Electrocardiogram for the Development of Wearable Devices.

BACKGROUND: Left heart abnormalities are risk factors for heart failure. However, echocardiography is not always available. Electrocardiograms (ECGs), which are now available from wearable devices, have the potential to detect these abnormalities. Nevertheless, whether a model can detect left heart abnormalities from single Lead I ECG data remains unclear.Methods and Results: We developed Lead I ECG models to detect low ejection fraction (EF), wall motion abnormality, left ventricular hypertrophy (LVH), left ventricular dilatation, and left atrial dilatation. We used a dataset comprising 229,439 paired sets of ECG and echocardiography data from 8 facilities, and validated the model using external verification with data from 2 facilities. The area under the receiver operating characteristic curves of our model was 0.913 for low EF, 0.832 for wall motion abnormality, 0.797 for LVH, 0.838 for left ventricular dilatation, and 0.802 for left atrial dilatation. In interpretation tests with 12 cardiologists, the accuracy of the model was 78.3% for low EF and 68.3% for LVH. Compared with cardiologists who read the 12-lead ECGs, the model's performance was superior for LVH and similar for low EF. CONCLUSIONS: From a multicenter study dataset, we developed models to predict left heart abnormalities using Lead I on the ECG. The Lead I ECG models show superior or equivalent performance to cardiologists using 12-lead ECGs.

Prevalence and Impact of Polyvascular Disease in Patients With Acute Myocardial Infarction in the Contemporary Era of Percutaneous Coronary Intervention　- Insights From the Japan Acute Myocardial Infarction Registry (JAMIR).

BACKGROUND: This post hoc subanalysis aimed to investigate the impact of polyvascular disease (PolyVD) in patients with acute myocardial infarction (AMI) in the contemporary era of percutaneous coronary intervention (PCI).Methods and Results: The Japan Acute Myocardial Infarction Registry (JAMIR), a multicenter prospective registry, enrolled 3,411 patients with AMI between December 2015 and May 2017. Patients were classified according to complications of a prior stroke and/or peripheral artery disease into an AMI-only group (involvement of 1 vascular bed [1-bed group]; n=2,980), PolyVD with one of the complications (2-bed group; n=383), and PolyVD with both complications (3-bed group; n=48). The primary endpoint was all-cause death. Secondary endpoints were major adverse cardiovascular events (MACE), including cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, and major bleeding. In the 1-, 2-, and 3-bed groups, the cumulative incidence of all-cause death was 6.8%, 17.5%, and 23.7%, respectively (P<0.001); that of MACE was 7.4%, 16.4%, and 33.8% (P<0.001), respectively; and that of major bleeding was 4.8%, 10.0%, and 13.9% (P<0.001), respectively. PolyVD was independently associated with all-cause death (hazard ratio [HR] 2.21; 95% confidence interval [CI], 1.48-3.29), MACE (HR 2.07; 95% CI 1.40-3.07), and major bleeding (HR 1.68; 95% CI 1.04-2.71). CONCLUSIONS: PolyVD was significantly associated with worse outcomes, including thrombotic and bleeding events, in the contemporary era of PCI in AMI patients.

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.

Effect of Infarction-Related Artery Location on Clinical Outcome of Patients With Acute Myocardial Infarction in the Contemporary Era of Percutaneous Coronary Intervention　- Subanalysis From the Prospective Japan Acute Myocardial Infarction Registry (JAMIR).

BACKGROUND: Previous studies have reported that acute myocardial infarction (AMI) related to left anterior descending (LAD) lesion is associated with worse outcomes than left circumflex artery (LCX) or right coronary artery (RCA) lesions. However, it is unknown whether those relationships are still present in the contemporary era of primary percutaneous coronary intervention (PCI), using newer generation drug-eluting stents and potent antiplatelet agents.Methods and Results:This study is a sub-analysis of the Japan AMI Registry (JAMIR), a multicenter, prospective registry enrolling 3,411 AMI patients between December 2015 and May 2017. Among them, 2,780 patients undergoing primary PCI for only a culprit vessel were included and stratified based on infarction-related artery type (LAD, LCX, and RCA). The primary outcome was 1-year cardiovascular death. The overall incidence of cardiovascular death was 3.4%. Patients with LAD infarction had highest incidence of cardiovascular death compared to patients with LCX and RCA infarction (4.8%, 1.3%, and 2.4%, respectively); however, landmark analysis showed that culprit vessel had no significant effect on cardiovascular death if a patient survived 30 days after primary PCI. LAD lesion infarction was an independent risk factor for cardiovascular death in adjusted Cox regression analysis. CONCLUSIONS: The present sub-analysis of the JAMIR demonstrated that LAD infarction is still associated with worse outcomes, especially during the first 30 days, even in the contemporary era of PCI.

Iatrogenic Atrial Septal Defect Requiring Transcatheter Closure Following Transcatheter Mitral Valve Repair.

BACKGROUND: Transcatheter mitral valve repair with the MitraClip system has been established in selected high-risk patients. The MitraClip procedure results in a relatively large iatrogenic atrial septal defect (iASD). This study aimed to investigate the prevalence and clinical course of iASD requiring transcatheter closure following the MitraClip procedure.Methods and Results: This study was conducted at all 59 institutions that perform transcatheter mitral valve repair with the MitraClip system in Japan. The data of patients on whom transcatheter iASD closure was performed were collected. Of the 2,722 patients who underwent the MitraClip procedure, 30 (1%) required transcatheter iASD closure. The maximum iASD size was 9±4 mm (range, 3-18 mm). The common clinical course of transcatheter iASD closure was hypoxemia with right-to-left shunt or right-sided heart failure with left-to-right shunt. Of the 30 patients, 22 (73%) required transcatheter closure within 24 h following the MitraClip procedure, including 12 with hypoxemia and 5 with right-sided heart failure complicated with cardiogenic shock. Of the 5 patients, 2 required mechanical circulatory support devices. Twenty-one patients immediately underwent transcatheter iASD closure, and hemodynamic deteriorations were resolved; however, 1 patient died without having undergone transcatheter closure. CONCLUSIONS: Transcatheter iASD closure was required in 1% of patients who underwent the MitraClip procedure. Many of these patients immediately underwent transcatheter iASD closure because of hypoxemia with right-to-left shunt or right-sided heart failure with left-to-right shunt.

Effect of Low Body Mass Index on the Clinical Outcomes of Japanese Patients With Acute Myocardial Infarction　- Results From the Prospective Japan Acute Myocardial Infarction Registry (JAMIR).

BACKGROUND: Acute myocardial infarction (AMI) patients with low body mass index (BMI) exhibit worse clinical outcomes than obese patients; however, to our knowledge, no prospective, nationwide study has assessed the effect of BMI on the clinical outcomes of AMI patients.Methods and Results:In this multi-center, prospective, nationwide Japanese trial, 2,373 AMI patients who underwent emergent percutaneous coronary intervention within 12 h of onset from the Japanese AMI Registry (JAMIR) were identified. Patients were divided into the following 4 groups based on their BMI at admission: Q1 group (BMI <18.5 kg/m2, n=133), Q2 group (18.5≤BMI<25.0 kg/m2, n=1,424), Q3 group (25.0≤BMI<30.0 kg/m2, n=672), and Q4 group (30.0 kg/m2≤BMI, n=144). The primary endpoint was all-cause death, and the secondary endpoint was a composite of cardiovascular death, non-fatal myocardial infarction (MI), and non-fatal stroke. The median follow-up period was 358 days. Q1 patients were older and had lower prevalence of coronary risk factors. Q1 patients also had higher all-cause mortality and higher incidence of secondary endpoints than normal-weight or obese AMI patients. Multivariate analysis showed that low BMI (Q1 group) was an independent predictor for primary endpoint. CONCLUSIONS: AMI patients with low BMI had fewer coronary risk factors but worse clinical outcomes than normal-weight or obese patients.

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.

Impact of Left Ventricular Chamber Size on Outcome in Heart Failure with Preserved Ejection Fraction.

Although heart failure with preserved ejection fraction (HFpEF) has a highly variable phenotype, heterogeneity in left ventricular chamber size (LVCS) and its association with long-term outcome have not been thoroughly investigated. The present study sought to determine the impact of LVCS on clinical outcome in HFpEF.A total of 1505 consecutive HFpEF patients admitted to hospitals in the multicenter WET-HF Registry for acute decompensated HF (ADHF) between 2006 and 2017 were analyzed. The patients (age: 80 [73-86], male: 48%) were divided into larger (L) or smaller (S) LV end-diastolic diameter (LVEDD) groups by the median value 45 mm.Younger age, male sex, higher body mass index, more favorable nutritional status, valvular etiology, and lower LVEF were associated with larger LVEDD. After propensity matching (399 pairs), the L group showed a larger left atrial diameter, E/e', and tricuspid regurgitation pressure gradient and greater severity of mitral regurgitation. The L group had a higher rate of composite endpoint of all-cause death and ADHF re-admission (P = 0.021) and was an independent predictor. On the other hand, in the pre-matched cohort, the S group rather showed higher in-hospital (4% versus 2%. P = 0.004) and post-discharge mortality (P = 0.009).In HFpEF, LVCS was affected by demographic and cardiac parameters. After adjustment for demographic parameters, larger LVCS was associated with worse clinical outcome. Higher mortality in the S group in the pre-matched cohort might be related to the demographic factors suggesting frailty and/or sarcopenia.

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.

Hospital-Acquired Functional Decline and Clinical Outcomes in Older Patients Undergoing Transcatheter Aortic Valve Implantation.

BACKGROUND: This study aimed to assess the relationship between hospital-acquired functional decline and the risk of mid-term all-cause death in older patients undergoing transcatheter aortic valve implantation (TAVI).Methods and Results:In total, 463 patients (mean age 85 years, interquartile range [IQR]: 82, 88) undergoing elective TAVI at Sakakibara Heart Institute between 2010 and 2018, who were followed up for 3 years, were enrolled in the study. Hospital-acquired functional decline after TAVI, which was defined by at least a 1-point decrease on the Short Physical Performance Battery before discharge compared to the preoperative score, was assessed. A total of 113 patients (24.4%) showed hospital-acquired functional decline after TAVI, and 50 (11.3%) patients died over a mean follow-up period of 1.9±0.8 years. Kaplan-Meier survival curves indicated that hospital-acquired functional decline was significantly associated with all-cause mortality (log-rank test, P=0.001). On multivariate Cox regression analysis, hospital-acquired functional decline was associated with a higher risk of all-cause mortality (OR 2.108, 95% CI 1.119-3.968, P=0.021) independent of sex, body mass index, advanced chronic kidney disease, and preoperative frailty, as assessed by the modified essential frail toolkit. CONCLUSIONS: Hospital-acquired functional decline is associated with mid-term all-cause mortality in older patients following TAVI. Trajectory of functional status is a vital sign, and it is useful for risk stratification in older patients following TAVI.

Clinical Differences of Recent Myocardial Infarction Compared With Acute Myocardial Infarction　- Insights From the Tokyo CCU Network Multicenter Registry.

BACKGROUND: Characteristics and treatment outcomes of acute myocardial infarction (AMI) patients have been studied; however, those of recent myocardial infarction (RMI) patients remain unclear. This study aimed to clarify characteristics, treatment strategy, and in-hospital outcomes of RMI patients in the Tokyo CCU network database.Methods and Results:In total, 1,853 RMI and 12,494 AMI patients from the Tokyo CCU network database during 2013-2016 were compared. Both RMI and AMI were redefined by onset times of 2-28 days and ≤24 h, respectively. The RMI group had a higher average age (70.4±12.9 vs. 68.0±13.4 years, P<0.001), more women (27.6% vs. 23.6%, P<0.001), lower proportion of patients with chest pain as the chief complaint (75.2% vs. 83.6%, P<0.001), higher prevalence of diabetes mellitus (35.9% vs. 31.0%, P<0.001), and higher mechanical complication incidence (3.0% vs. 1.5%, P<0.001) than did the AMI group. Thirty-day mortality was comparable (5.3% vs. 5.8%, P=0.360); major causes of death were cardiogenic shock and mechanical complications in the AMI and RMI groups, respectively. Death from mechanical complications (not onset time) in the AMI group plateaued almost 1 week after hospitalization, whereas it continued to increase in the RMI group. CONCLUSIONS: Both RMI and AMI patients have distinctive clinical features, sequelae, and causes of death. Although treatment of RMI patients adhered to guidelines, it was insufficient, and death from mechanical complications continues to increase.

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.

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.

Physical performance as a predictor of midterm outcome after mitral valve surgery.

The usefulness of performing physical function assessments for evaluating clinical outcomes after all cardiac surgeries has been reported. However, no studies have evaluated the relationship between physical function and prognosis in patients undergoing cardiac open surgery with mitral valve regurgitation (MR). This study investigated whether physical assessment, such as the short physical performance battery (SPPB), could predict unplanned readmission events in patients undergoing mitral valve surgery due to MR. SPPB could predict unplanned admission events in patients undergoing mitral valve surgery due to MR. This retrospective study included 168 patients who underwent mitral valve surgery. SPPB was performed 1.6 ± 1.1 days before surgery. The primary endpoint was unplanned readmission. The mean follow-up period was 762 ± 480 days, mean age was 73.8 ± 6.3 years, and 43% of the patients were women. Of the study patients, 46 required unplanned readmissions; 29 of these patients required readmissions within 1 year. Multivariate Cox regression analysis demonstrated that SPPB was independently associated with the primary endpoint. Receiver-operating characteristic analysis showed that SPPB had an area under the curve of 0.71, with an optimal cutoff of 11. The study patients were stratified into SPPB 12 or SPPB ≤ 11 groups. Kaplan-Meier analysis showed that the event-free rate was significantly lower in the SPPB ≤ 11 group (hazard ratio 3.8, 95% confidence interval 2.1-7.0; p < 0.001). SPPB was a useful tool for predicting unplanned readmission in patients undergoing mitral valve surgery due to MR.

Higher non-cardiac mortality and lesser impact of early revascularization in patients with type 2 compared to type 1 acute myocardial infarction: results from the Tokyo CCU Network registry.

As the definition of type 2 acute myocardial infarction (AMI) is obscure, the characteristics of this disease vary among studies. The clinical significance of type 2 AMI is unclear. We surveyed the Tokyo Cardiovascular Care Unit (CCU) Network registry between 2010 and 2014. The difference in clinical characteristics and the impact of revascularization in patients with type 1 and type 2 AMI were evaluated. The cohort study included 12514 patients admitted to CCU (type 1 AMI, 12023; type 2 AMI, 491; mean age, 68 ± 15 years; 75% male). Coronary angiography was performed in 11402 patients (95%) with type 1 AMI and 427 (87%) with type 2 AMI (p < 0.001). Type 2 AMI was associated with higher in-hospital mortality (type 1 AMI, 769 (6.4%); type 2 AMI, 54 (11.0%); adjusted odds ratio (OR) 1.64; 95% confidence interval (CI) 1.12-2.41; p = 0.011) and higher non-cardiac mortality (adjusted OR 2.19; 95% CI 1.33-3.62; p = 0.002), but similar cardiac mortality rate compared to type 1 AMI (adjusted OR 1.17; 95% CI 0.71-1.91; p = 0.539). Percutaneous coronary intervention (PCI) within 24 h after the onset was associated with lower in-hospital mortality in those with type 1 AMI (OR 0.47; 95% CI 0.40-0.55; p < 0.001), but not in those with type 2 AMI (OR 1.09; 95% CI 0.62-1.94; p = 0.763). The results persisted after adjustment for multivariate logistic regression analysis and inverted probability weighting. In conclusion, patients with type 2 AMI had higher in-hospital mortality owing to higher non-cardiac death. More refined definitions focusing on the treatment of comorbidities may be required, as the treatment strategy for type 2 AMI can be different from that for type 1 AMI.