Haemodynamic and clinical outcomes at 5 years according to predicted prosthesis-patient mismatch after transcatheter aortic valve replacement.

BACKGROUND/PURPOSE: Although the impact of predicted prosthesis-patient mismatch (PPMP) on outcomes after surgical aortic valve replacement is well established, studies on PPMP in transcatheter aortic valve replacement (TAVR) are limited. This study investigated the effects of PPMp on haemodynamic and 5-year clinical outcomes after TAVR. METHODS/MATERIALS: We analysed 1733 patients who underwent TAVR. PPMp was defined using two different methods: 1) normal reference values of the effective orifice area for each valve type and size indexed to body surface area (PPMp1; n = 1733) and 2) reference values for aortic annulus area or perimeter assessed with pre-procedural computed tomography indexed to body surface area (PPMp2; n = 1227). The primary endpoint was the composite of all-cause death and/or rehospitalisation for heart failure at 5 years. RESULTS: The incidence of PPMp1 was 11.7 % and 0.8 % in moderate and severe cases, respectively. PPMp2 was classified as either moderate (3.8 %) or severe (0 %). Rates of residual mean aortic gradient ≥20 mmHg significantly increased depending on PPMp1 severity (no PPMp1: 3.1 % vs. moderate PPMp1: 26.8 % vs. severe PPMp1: 53.9 %, p < 0.0001) and PPMp2 (no PPMp2: 4.1 % vs. moderate PPMp2: 12.8 %, p = 0.0049). Neither of PPMP methods were associated with the composite outcome in total cohort; however, PPMP1 was significantly related to worse clinical outcomes at 5 years among patients with reduced left ventricular ejection fraction (LVEF) in multivariate analysis (HR: 1.87; 95 % CI: 1.02-3.43). CONCLUSIONS: The impact of PPMP on TAVR clinical outcomes may not be negligible in patients with low LVEF.

Sodium-Glucose Cotransporter-2 Inhibitors Stabilize Coronary Plaques in Acute Coronary Syndrome With Diabetes Mellitus.

Sodium-glucose cotransporter-2 inhibitors (SGLT2is) are widely used in cardiology and are effective in treating acute coronary syndrome (ACS). Their effects on unstable plaque in patients with ACS remains unclear. This study aimed to examine the effectiveness of SGLT2is in coronary plaque based on optical coherence tomography (OCT) images and the prognosis of ACS with type 2 diabetes mellitus. This retrospective study included 109 patients in the total cohort and 29 patients in the OCT cohort. Based on SGLT2i administration after ACS, the total cohort was categorized into non-SGLT2i (n = 69) and SGLT2i (n = 40) groups. The OCT cohort had 15 and 14 patients in the non-SGLT2i and SGLT2i groups, respectively. The OCT images of unstable plaque were analyzed in nonstented lesions during ACS catheterization and at the 6-month follow-up. The total cohort was assessed after 1 year for major adverse cardiovascular events, including all-cause mortality, revascularization, cerebrovascular disease, and heart failure hospitalization. SGLT2is improved unstable lesions with a significantly thicker fibrous cap (48 ± 15 µm vs 26 ± 24 µm, p = 0.005), reduced lipid arc (-29 ± 12° vs -18 ± 14°, p = 0.028), higher % decrease in total lipid arc (-35 ± 13% vs -19 ± 18%, p = 0.01), and lower major adverse cardiovascular event incidence (log-rank p = 0.023, hazard ratio 4.72 [1.08 to 20.63]) and revascularization rate (adjusted hazard ratio 6.77 [1.08 to 42.52]) than the non-SGLT2i group. In conclusion, SGLT2is can improve the markers of plaque stability and may improve the prognosis in patients with type 2 diabetes mellitus.

Long-Term Assessment of Survival After Transcatheter Aortic Valve Implantation　- Insights From the International Transcatheter Aortic Valve Implantation Registry.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) is an established treatment for severe aortic stenosis (AS), but despite estimates of life expectancy after TAVI being essential in heart team discussion, these data are scarce. Therefore, the current study sought to assess long-term survival and its trends in relation to chronological age, surgical risk, and treatment period.Methods and Results: We included 2,414 consecutive patients who underwent TAVI for severe symptomatic AS between 2008 and 2021 at 2 international centers. For the analysis, long-term survival was evaluated according to age, surgical risk, and treatment period categorized into 3 groups, respectively. The longest follow-up was 13.5 years. Overall survival was 67.6% at 5 years and 26.9% at 10 years. Younger patients, lower surgical risk, and later treatment period showed better survival (log-rank P<0.001, respectively). In the multivariate analysis, age <75years, lower surgical risk, and later time period were significantly associated with better survival. The incidence of paravalvular leakage ≥moderate, red blood cell transfusion, and acute kidney injury were independently associated with increasing risk of 5-year death. CONCLUSIONS: In a real-world registry, survival was substantial following TAVI, especially in younger and lower surgical-risk patients, with improving outcomes over time. This should be considered in heart team discussions of life-long management for AS patients after TAVI.

Risk Assessment of Permanent Pacemaker Implantation After Transcatheter Aortic Valve Implantation in Patients With Preexisting Right Bundle Branch Block.

Preexisting right bundle branch block (RBBB) is the strongest predictor for permanent pacemaker implantation (PPI) after transcatheter aortic valve implantation (TAVI). However, the risk assessment for new PPI and effective procedural strategy for preventing new PPI in patients with preexisting RBBB are still unclear. This study stratified the new PPI risk after TAVI and investigated the impact of implantation strategy in a preexisting RBBB cohort. We analyzed 237 patients with preexisting RBBB who underwent TAVI. The primary endpoint was the incidence of new PPI. Multivariate analyses investigating predictors for new PPI were performed. The overall PPI rate was 33.3%. Significant baseline predictors for new PPI were combination of RBBB, left anterior or posterior fascicular block, and first-degree atrioventricular block (odds ratio [OR] 2.55, 95% confidence interval [CI] 1.09 to 5.04), high calcium volume of noncoronary cusp (OR 2.08, 95% CI 1.05 to 4.10), and membranous septum (MS) length <2 mm (OR 2.02, 95% CI 1.09 to 3.75) in the univariate analysis and MS length <2 mm (OR 2.25, 95% CI 1.06 to 4.82) in the multivariate analysis. On the multivariate analysis including procedural variables, predilatation (OR 2.41, 95% CI 1.01 to 5.83), self-expanding valves (Corevalve, Evolut R, and Evolut Pro/Pro+; Medtronic Inc., Minneapolis, Minnesota) or mechanical expanding valves (Lotus/Lotus Edge; Boston Scientifics, Marlborough, Massachusetts) (OR 3.00, 95% CI 1.31 to 6.91), and implantation depth > MS length (OR 4.27, 95% CI 1.81 to 10.08) were significantly associated with new PPI. The incidence of new PPI increased according to the number of baseline predictors (0: 20.9%, 1: 34.3%, and ≥2: 52.0%) and procedural predictors (0: 3.7%, 1: 20.9%, 2: 40.5%, and 3: 60.0%). New PPI risk in a preexisting RBBB subset could be stratified by baseline factors. Device selection and implantation strategy considering MS length could prevent new PPI even in these high-risk population.

Hemodynamics and Conduction Disturbance After Transcatheter Aortic Valve Implantation With SAPIEN3 Ultra Versus SAPIEN3: The HomoSAPIEN 2 Study.

The optimal percent oversizing (%OS) using the SAPIEN3 Ultra (S3U) weighing the incidence of paravalvular regurgitation (PVR) ≥ mild against the risk of conduction disturbance (CD) is not known. This study sought to define an optimal extent of the annulus area %OS suitable for transcatheter aortic valve implantation with the S3U compared with the SAPIEN3 (S3). A total of 350 patients with the S3U were compared with 606 patients with the S3. Patients were categorized depending on the degree of %OS. PVR ≥ mild was observed in 8.9% of patients with the S3U and in 21.8% of those with the S3 (p <0.001). The S3U demonstrated a sustainably lower incidence of PVR ≥ mild than the S3 in any extent of %OS. There was an inverse proportional relation between the extent of %OS and frequency of PVR ≥ mild in the S3, whereas the S3U group provided little change. The incidences of PVR ≥ mild were steady >5%OS in the S3 (5% to 10%OS: 13.3%, and >10%OS: 12.1%) and >0%OS in the S3U (0% to 5%OS: 5.9%, 5% to 10%OS: 6.0%, and >10%OS: 6.1%). An increasing %OS was independently associated with the occurrence of CD (<0%OS: 9.8%, 0% to 5%OS: 13.1%, 5% to 10%OS: 16.6%, and >10%OS: 19.2%, p = 0.012). The incidence of PVR ≥ mild and/or CD was the lowest (10.1%) in the 0% to 5%OS in patients with the S3U. In conclusion, the HomoSAPIEN2 study suggests that the S3U tolerates a lesser degree of %OS for mitigating PVR ≥ mild than the S3. Minimal %OS, ranging from 0% to 5%, may be optimal for the S3U with balancing the risk of PVR and CD. Trial Identifier: UMIN000040413/URL: https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000046115.

Optical Coherence Tomography-Guided Percutaneous Coronary Intervention for ST-Segment Elevation Myocardial Infarction: Rationale and Design of the ATLAS-OCT Study.

Even after successful revascularization with primary percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI), subsequent adverse events still occur. Previous studies have suggested potential benefits of intravascular imaging, including optical coherence tomography (OCT). However, the feasibility of OCT-guided primary PCI has not been systematically examined in these patients. The ATLAS-OCT (ST-elevation Acute myocardial infarcTion and cLinicAl outcomeS treated by Optical Coherence Tomography-guided percutaneous coronary intervention) trial was designed to investigate the feasibility of OCT guidance during primary PCI for STEMI in experienced centers with expertise on OCT-guided PCI as a prospective, multicenter registry of consecutive patients with STEMI who underwent a primary PCI. The sites' inclusion criteria are as follows: (1) acute care hospitals providing 24/7 emergency care for STEMI, and (2) institutions where OCT-guided PCI is the first choice for primary PCI in STEMI. All patients with STEMI who underwent primary PCI at participating sites will be consecutively enrolled, irrespective of OCT use during PCI. The primary end point will be the rate of successful OCT imaging during the primary PCI. As an ancillary imaging modality to angiography, OCT provides morphologic information during PCI for the assessment of plaque phenotypes, vessel sizing, and PCI optimization. Major adverse cardiac events, defined as a composite of all-cause death, myocardial infarction, and target vessel revascularization at 1 year, will also be recorded. The ATLAS-OCT study will clarify the feasibility of OCT-guided primary PCI for patients with STEMI and further identify a suitable patient group for OCT-guided primary PCI.

Early Effect of Transcatheter Mitral Valve Repair on Cardiac Sympathetic Nerve Activity.

Background: Cardiac sympathetic nerve activity (SNA) is overactivated in heart failure patients and associated with clinical outcomes. The aim of this study is to investigate the early effect of MitraClip repair on cardiac SNA. Methods: We evaluated the change of cardiac SNA by 123I- meta-iodobenzylguanidine (MIBG) scintigraphy in patients who underwent MitraClip repair from March 2019 to June 2020 in our hospital. Patients without acute procedural success were excluded, including patients who died or underwent mitral valve surgery before discharge. MIBG scintigraphy was performed at baseline and 1 â€‹month after MitraClip repair. Results: We analyzed 48 patients (mean age 78.6 ± 10 years; 52.1% male; 37 secondary mitral regurgitation [SMR]/11 primary mitral regurgitation [PMR]). MR severity and New York Heart Association functional class significantly improved from baseline to 1 â€‹month after MitraClip repair (both p < 0.001). Overall, delay heart-mediastinum ratio (H/M) had no significant change, and washout rate (WR) showed a decreasing trend (delay H/M; pre 2.07 ± 0.46, post 2.05 ± 0.49, paired p = 0.348, WR; pre 36.1 ± 11.6%, post 33.6 ± 11.7%, paired p = 0.061). In PMR patients, WR was significantly decreased, however, delay H/M was not (delay H/M; pre 2.15 ± 0.50, post 2.10 ± 0.57, paired p = 0.019, WR; pre 34.6 ± 10.5%, post 26.7 ± 13.8%, paired p = 0.568). In contrast, in SMR patients, neither delay H/M nor WR were significantly changed (delay H/M; pre 2.05 ± 0.45, post 2.03 ± 0.47, paired p = 0.474, WR; pre 36.6 ± 11.9%, post 35.7 ± 10.4%, paired p = 0.523). Conclusions: Our study demonstrates that MitraClip repair could significantly decrease cardiac SNA of WR in PMR patients during 1-month follow-up, however, in SMR patients, the significant change of MIBG parameters was not observed.

Impact of High Implantation of Transcatheter Aortic Valve on Subsequent Conduction Disturbances and Coronary Access.

BACKGROUND: Data regarding the impact of high transcatheter heart valve (THV) implantation on coronary access after transcatheter aortic valve replacement (TAVR) as assessed by postimplantation computed tomography (CT) are scarce. OBJECTIVES: The authors sought to assess the impact of high THV implantation on coronary access after TAVR. METHODS: We included 160 and 258 patients treated with Evolut R/PRO/PRO+ and SAPIEN 3 THVs, respectively. In the Evolut R/PRO/PRO+ group, the target implantation depth was 1 to 3 mm using the cusp overlap view with commissural alignment technique for the high implantation technique (HIT), whereas it was 3 to 5 mm using 3-cusp coplanar view for the conventional implantation technique (CIT). In the SAPIEN 3 group, the HIT employed the radiolucent line-guided implantation, whereas the central balloon marker-guided implantation was used for the CIT. Post-TAVR CT was performed to analyze coronary accessibility. RESULTS: HIT reduced the incidence of new conduction disturbances after TAVR for both THVs. In the Evolut R/PRO/PRO+ group, post-TAVR CT showed that the HIT group had a higher incidence of the interference of THV skirt (22.0% vs 9.1%; P = 0.03) and a lower incidence of the interference of THV commissural posts (26.0% vs 42.7%; P = 0.04) with access to 1 or both coronary ostia compared with the CIT group. These incidences were similar between the HIT and CIT groups in the SAPIEN 3 group (THV skirt: 0.9% vs 0.7%; P = 1.00; THV commissural tabs: 15.7% vs 15.3%; P = 0.93). In both THVs, CT-identified risk of sinus sequestration in TAVR-in-TAVR was significantly higher in the HIT group compared with the CIT group (Evolut R/PRO/PRO+ group: 64.0% vs 41.8%; P = 0.009; SAPIEN 3 group: 17.6% vs 5.3%; P = 0.002). CONCLUSIONS: High THV implantation substantially reduced conduction disturbances after TAVR. However, post-TAVR CT revealed that there is a risk for unfavorable future coronary access after TAVR and sinus sequestration in TAVR-in-TAVR. (Impact of High Implantation of Transcatheter Heart Valve during Transcatheter Aortic Valve Replacement on Future Coronary Access; UMIN000048336).

Impact of Mild Paravalvular Regurgitation on Long-Term Clinical Outcomes After Transcatheter Aortic Valve Implantation.

The impact of mild paravalvular regurgitation (PVR) after transcatheter aortic valve implantation (TAVI) remains controversial. We evaluated the impact of mild PVR after TAVI on long-term clinical outcomes. We included patients who underwent TAVI for severe symptomatic aortic stenosis between December 2008 and June 2019 at 2 international centers and compared all-cause death between the group with mild PVR (group 1) and the group with none or trace PVR (group 2). PVR was categorized using a 3-class grading scheme, and patients with PVR ≧ moderate and those who were lost to follow-up were excluded. This retrospective analysis included 1,404 patients (mean age 81.7 ± 6.5 years, 58.0% women). Three hundred fifty eight patients (25.5%) were classified into group 1 and 1,046 patients (74.5%) into group 2. At baseline, group 1 was older and had a lower body mass index, worse co-morbidities, and more severe aortic stenosis. To account for these differences, propensity score matching was performed, resulting in 332 matched pairs. Within these matched groups, during a mean follow-up of 3.2 years, group 1 had a significantly lower survival rate at 5 years (group 1: 62.0% vs group 2: 68.0%, log-rank p = 0.029, hazard ratio: 1.41 [95% confidence interval: 1.04 to 1.91]). In the matched cohort, patients with mild PVR had a significant 1.4-fold increased risk of mortality at 5 years after TAVI compared with those with none or trace PVR. Further studies with more patients are needed to evaluate the impact of longer-term outcomes.

Five-year clinical outcomes of a 2.25 mm sirolimus-eluting stent in Japanese patients with very small coronary artery disease: final results of the CENTURY JSV study.

The aim of this study is to evaluate the long-term safety and efficacy of the 2.25 mm bioresorbable-polymer sirolimus-eluting Ultimaster stent in a Japanese patient population. Treatment of coronary artery disease in very small vessels is associated with an increased risk for cardiac events. The CENTURY JSV study is a prospective, multicenter, single-arm study. Seventy patients with stable and unstable coronary artery disease with a coronary lesion eligible for implantation with a 2.25 mm stent were enrolled in this study. Patients underwent clinical follow-up through 5-year after the PCI procedure. The mean age was 70.4 ± 9.2 years. The prevalence of diabetes mellitus was 37.1%, all not insulin dependent. The incidence of major adverse cardiac events, defined as cardiac death, target vessel myocardial infarction (MI), and clinically driven target lesion revascularization (CD-TLR) at 5 years was 5.7%. A non-Q wave MI was noted in 1.4% and 4.3% underwent a CD-TLR. There was no stent thrombosis during the entire follow-up period. No cardiac events were reported between 2 and 5 years. This is the first study to demonstrate safety and effectiveness for 5 years after treatment of very small coronary disease with 2.25 mm-diameter DES.Clinical trial registration: UMIN000012928.

Discordance between fractional flow reserve and instantaneous wave-free ratio in patients with severe aortic stenosis: A retrospective cohort study.

BACKGROUND: Discordance between fractional flow reserve (FFR) and instantaneous wave-free ratio (iFR) occurs in approximately 20 % of cases. However, no studies have reported the discordance in patients with severe aortic stenosis (AS). We aimed to evaluate the diagnostic discordance between FFR and iFR in patients with severe AS. METHODS: We examined 140 consecutive patients with severe AS (164 intermediate coronary artery stenosis vessels). FFR and iFR were calculated in four quadrants based on threshold FFR and iFR values of ≤0.8 and ≤0.89, respectively (Group 1: iFR >0.89, FFR >0.80; Group 2: iFR ≤0.89, FFR >0.80; Group 3: iFR >0.89, FFR ≤0.80; and Group 4: iFR ≤0.89, FFR ≤0.80). Concordant groups were Groups 1 and 4, and discordant groups were Groups 2 and 3. Positive and negative discordant groups were Groups 3 and 2, respectively. RESULTS: The median (Q1, Q3) FFR and iFR were 0.84 (0.76, 0.88) and 0.85 (0.76, 0.91), respectively. Discordance was observed in 48 vessels (29.3 %). In the discordant group, negative discordance (Group 2: iFR ≤0.89 and FFR >0.80) was predominant (45 cases, 93.6 %). Multivariate analysis showed that the left anterior descending artery [odds ratio (OR), 3.88; 95 % confidence interval (CI): 1.54-9.79, p = 0.004] and peak velocity ≥5.0 m/s (OR, 3.21; 95%CI: 1.36-7.57, p = 0.008) were independently associated with negative discordance (FFR >0.8 and iFR ≤0.89). CONCLUSIONS: In patients with severe AS, discordance between FFR and iFR was predominantly negative and observed in 29.3 % of vessels. The left anterior descending artery and peak velocity ≥5.0 m/s were independently associated with negative discordance.

Percutaneous transvenous mitral commissurotomy and transcatheter aortic valve replacement for rheumatic mitral and aortic stenosis.

The indications for transfemoral transcatheter aortic valve replacement (TAVR) have been expanding; however, treatment protocol for patients with severe aortic stenosis with other significant valve disease is still controversial. Furthermore, there are few randomized data to guide therapy in multivalvular disease. We describe a successful percutaneous transvenous mitral commissurotomy and TAVR simultaneously. A 3-year follow-up echocardiography showed preserved valve function. Learning objective: A combination of percutaneous transvenous mitral commissurotomy and transcatheter aortic valve replacement for multivalvular disease with severe mitral stenosis and aortic stenosis may be a treatment option. For multivalvular disease, heart team decisions can be valuable for an optimal management strategy.

Distal Transradial Access For Cardiac Catheterization in Patients Undergoing Hemodialysis.

OBJECTIVES: Although a distal radial artery (DRA) approach has recently been used in patients undergoing cardiac catheterization, no studies have so far investigated the safety and feasibility of DRA in patients undergoing hemodialysis (HD). We aimed to investigate the incidence of conventional radial artery (CRA) occlusion and puncture site complications after DRA puncture in patients undergoing HD. METHODS: We retrospectively analyzed the data of 117 consecutive patients with HD who underwent coronary angiography or percutaneous coronary intervention via a DRA approach at our institution from September 2017 to December 2019. The primary endpoint was the incidence of CRA occlusion after DRA puncture, as assessed via vascular ultrasonography. Secondary endpoints included difficulty achieving hemostasis, DRA occlusion, aneurysm, arteriovenous shunt, and acute ischemia. RESULTS: The DRA puncture was successful in 106 patients (success rate: 90.5%). Because 21 patients lacked postprocedural vascular ultrasonography data, the primary endpoint was evaluated in 85 patients. CRA occlusion occurred in three patients (3.5%) following DRA puncture. DRA occlusion and aneurysm occurred in five patients (5.9%) and one patient (1.2%), respectively. CONCLUSIONS: Catheterization through DRA is feasible in patients undergoing HD, with a clinically acceptable incidence of CRA and complications.

Coronary Access After TAVR With a Cylindrical-Shaped Valve: Learning From LOTUS.

BACKGROUND/PURPOSE: Data on the feasibility of coronary access (CA) through above or outside of the cylindrical shaped-transcatheter heart valve (THV) are very limited. The aims of the present study were to assess the feasibility of CA after transcatheter aortic valve replacement (TAVR) with the LOTUS using multi detector computed tomography (MDCT) and the reliability of algorithm detecting unfavorable CA. METHODS/MATERIALS: Post-TAVR MDCT of 41 patients with 82 coronary arteries were evaluated. The relationship and distance between the THV flame and sinotubular junction (STJ) and coronary ostia were assessed. Unfavorable CA was defined as the valve-to-STJ distance < 2-mm or the valve-to-coronary ostia distance < 2-mm if the THV flame was above STJ or coronary ostia. RESULTS: MDCT-identified unfavorable CA was observed in 29.3% for the left coronary artery and 41.5% for the right coronary artery. In total, 53.7% of patients had at least one unfavorable CA and 14.6% of those had unfavorable CA for both left and right coronary artery. While patients underwent coronary angiography after TAVR, the success rates of selective coronary cannulation were significantly lower in patients with MDCT-identified unfavorable CA in comparison to those with favorable CA for left (20.0% vs. 100%, P = 0.002) and right coronary artery (0% vs. 100%, P < 0.001). CONCLUSIONS: Future CA through above or outside of a cylindrical shaped THV may be challenging with a significant probability. Our algorithm identifying unfavorable CA using post-MDCT seems to be useful for estimating the risk of unsuccessful selective cannulation.

Prognostic Value of Ventricular-Arterial Coupling After Transcatheter Aortic Valve Replacement on Midterm Clinical Outcomes.

Background Ventricular-arterial coupling predicts outcomes in patients with heart failure. The arterial elastance to end-systolic elastance ratio (Ea/Ees) is a noninvasively assessed index that reflects ventricular-arterial coupling. We aimed to determine the prognostic value of ventricular-arterial coupling assessed through Ea/Ees after transcatheter aortic valve replacement to predict clinical events. Methods and Results We retrieved data on 1378 patients (70% women) who underwent transcatheter aortic valve replacement between October 2013 and May 2017 from the OCEAN-TAVI (Optimized transCathEter vAlvular iNtervention) Japanese multicenter registry. We determined the association between Ea/Ees and the composite end point of hospitalization for heart failure and cardiovascular death by classifying the patients into quartiles based on Ea/Ees values (group 1: <0.326; group 2: 0.326-0.453; group 3: 0.453-0.666; and group 4: >0.666) during the midterm follow-up after transcatheter aortic valve replacement. During a median follow-up period of 736 days (interquartile range, 414-956), there were 247 (17.9%) all-cause deaths, 89 (6.5%) cardiovascular deaths, 130 (9.4%) hospitalizations for heart failure, and 199 (14.4%) composite events of hospitalization for heart failure and cardiovascular death. The incidence of the composite end point was significantly higher in group 2 (hazard ratio [HR], 1.76; 95% CI, 1.08-2.87 [P=0.024]), group 3 (HR, 2.43; 95% CI, 1.53-3.86 [P<0.001]), and group 4 (HR, 2.89; 95% CI, 1.83-4.57 [P<0.001]) than that in group 1. On adjusted multivariable Cox analysis, Ea/Ees was significantly associated with composite events (HR, 1.47 per 1-unit increase; 95% CI, 1.08-2.01 [P=0.015]). Conclusions These findings suggest that a higher Ea/Ees at discharge after transcatheter aortic valve replacement is associated with adverse clinical outcomes during midterm follow-up. Registration URL: https://www.upload.umin.ac.jp/. Unique identifier: UMIN000020423.

Exposed Hematoma After Pacemaker Generator Change.

A pacemaker generator change for a frail woman was performed with a direct oral anticoagulant. After the procedure, a hematoma was exposed. Stopping direct oral anticoagulants in frail patients should be considered before the procedure. (Level of Difficulty: Beginner.).

Effect of Sex on Mortality and Left Ventricular Remodeling After Transcatheter Aortic Valve Implantation.

BACKGROUND: The effect of sex on mortality is controversial; furthermore, sex differences in left ventricular (LV) remodeling after transcatheter aortic valve implantation (TAVI) remain unknown.Methods and Results:This study included 2,588 patients (1,793 [69.3%] female) enrolled in the Optimized CathEter vAlvular iNtervention (OCEAN)-TAVI Japanese multicenter registry between October 2013 and May 2017. We retrospectively analyzed the effect of sex on mortality, and evaluated changes in the LV mass index (LVMI) after TAVI. Female sex was significantly associated with lower all-cause and cardiovascular mortality (log-rank P<0.001 for both). Multivariate analysis showed that female sex was independently associated with lower cumulative long-term mortality (hazard ratio 0.615; 95% confidence interval 0.512-0.738; P<0.001). Regression in the LVMI was observed in both sexes, and there was no significant difference in the percentage LVMI regression from baseline to 1 year after TAVI between women and men. Women had a survival advantage compared with men among patients with LVMI regression at 1 year, but not among patients with no LVMI regression. CONCLUSIONS: We found that female sex is associated with better survival outcomes after TAVI in a large Japanese registry. Although LVMI regression was observed in women and men after TAVI, post-procedural LV mass regression may be related to the sex differences in mortality.