Right Ventricular Dysfunction in Patients With Concomitant Tricuspid Regurgitation Undergoing Transcatheter Aortic Valve Implantation.

BACKGROUND: This study investigated the impact and predictive factors of concomitant significant tricuspid regurgitation (TR) and evaluated the roles of right ventricle (RV) function and the etiology of TR in the clinical outcomes of patients with severe aortic stenosis undergoing transcatheter aortic valve implantation (TAVI).Methods and Results: We assessed grading of TR severity, TR etiology, and RV function in pre- and post-TAVI transthoracic echocardiograms for 678 patients at Keio University School of Medicine. TR etiology was divided into 3 groups: primary TR, ventricular functional TR (FTR), and atrial FTR. The primary outcomes were all-cause and cardiovascular death. At baseline, moderate or greater TR was found in 55 (8%) patients and, after adjustment for comorbidities, was associated with increased all-cause death (hazard ratio [HR] 2.11; 95% confidence interval [CI] 1.19-3.77; P=0.011) and cardiovascular death (HR 2.29; 95% CI 1.06-4.99; P=0.036). RV dysfunction (RVD) also remained an independent predictor of cardiovascular death (HR 2.06; 95% CI 1.03-4.14; P=0.042). Among the TR etiology groups, patients with ventricular FTR had the lowest survival rate (P<0.001). Patients with persistent RVD after TAVI had a higher risk of cardiovascular death than those with a normal or recovered RV function (P<0.001). CONCLUSIONS: The etiology of TR and RV function play an important role in predicting outcomes in concomitant TR patients undergoing TAVI.

Natural History of Leaflet Thrombosis After Transcatheter Aortic Valve Replacement: A 5-Year Follow-Up Study.

Background Subclinical leaflet thrombosis, characterized by hypoattenuated leaflet thickening (HALT) on multidetector computed tomography, is common after transcatheter aortic valve replacement (TAVR). Because little is known about the long-term natural history of subclinical HALT, we aimed to investigate this in patients who underwent TAVR without using additional anticoagulation. Methods and Results We retrospectively evaluated patients who underwent TAVR with the Edwards SAPIEN-XT at our institute between October 2013 and December 2015. Patients were grouped according to the presence or absence of HALT within 1 year after TAVR (HALT and No-HALT groups). The primary outcome, defined as the composite of all-cause mortality, heart failure readmission, and ischemic stroke, was compared. Valve performance was assessed over time by transthoracic echocardiography. Among 124 patients (men: 29.1%; median age, 85 years), 27 (21.8%) showed HALT on multidetector computed tomography within 1 year after TAVR. No patient required additional anticoagulation for treating HALT because of the absence of valve-related symptomatic deterioration. During the median follow-up period of 4.7 years (interquartile range, 4.0-5.6), the rate of primary outcome and valve performance was not statistically different between the 2 groups (37.0% versus 38.1%; log-rank test P=0.92; mean pressure gradient, 9 mm Hg [8-14 mm Hg] versus 10 mm Hg [7-15 mm Hg]; P=0.51, respectively). Conclusions Approximately 20% of patients after TAVR had HALT within 1 year; however, that did not change the risk of subsequent adverse cardiovascular events or the valve performance with statistical significance for up to 5 years despite no additional anticoagulation therapy.

Elderly aortic stenosis patients' perspectives on treatment goals in transcatheter aortic valvular replacement.

AIMS: Transcatheter aortic valvular replacement (TAVR) is increasingly being performed for elderly patients with aortic stenosis (AS), and current guidelines acknowledge the importance of shared decision-making in their management. This study aimed to evaluate elderly symptomatic severe AS patients' perspectives on their treatment goals and identify factors that influence their treatment choice. METHODS AND RESULTS: We performed a pre-procedural cross-sectional survey using a questionnaire at a single university hospital. The questionnaire included three primary domains: (i) symptom burden, (ii) goals and important factors related to treatment, and (iii) preferred place of residence after treatment. We investigated 98 symptomatic severe AS patients who underwent TAVR (median age 86 years, 26% men). None of the patients died during hospitalization, and most of them (94%) were discharged home. Prior to TAVR, the three most common symptom burdens were poor mobility (52%), shortness of breath (52%), and weakness (44%). The reported preferred treatment goals were symptom burden reduction (78%), independence maintenance (68%), ability to perform a specific activity/hobby (62%), and improvement in prognosis (58%). In total, 54% of the patients rated 'in alignment with my values' as the factor that affected their decision to undergo TAVR. Nearly all patients (95%) stated that they preferred to live at home after TAVR. CONCLUSIONS: Among elderly AS patients with varying symptoms who underwent TAVR, symptom burden reduction was the most cited patient-reported goal. Nearly all the patients preferred to live at home after the procedure. Encouraging patients to define their specific goals may improve the quality of shared decision-making in such settings.

Late expansion of mechanically expanding transcatheter aortic valves.

Several studies have demonstrated better hemodynamic stability of mechanically expanding valves following transcatheter aortic valve replacement (TAVR). This study aims to assess the expansion or recoil of transcatheter aortic valves using multidetector computed tomography (MDCT). This was a retrospective study. Among 873 patients who underwent TAVR with balloon-expandable (SAPIEN 3) or mechanically expanding valves (LOTUS) at Keio University Hospital between 2013 and 2020, those who underwent serial MDCT and echocardiographic assessment (pre-procedure, discharge, 6 months, 1 year, and 2 years post-TAVR) as our hospital protocol were included in this analysis (N = 30; LOTUS = 12; SAPIEN 3 = 18). The pre- and post-procedural echocardiographic data and the valve expansion rate evaluated by MDCT were compared between the groups. In LOTUS valves, late-phase expansion was observed on computed tomography (mean expansion rate, 83.8% at discharge and 86.8%, 2 years postoperative, p < 0.001), and a gradual increase in the aortic valve area was observed on echocardiography (aortic valve area: 1.45 cm2 at discharge and 1.51 cm2, 2 years postoperative, p = 0.01). Conversely, in SAPIEN 3, valve expansion was not seen in the late phase (mean expansion rate, 84.5% at discharge and 83.8%, 2 years postoperative) with a decrease in the aortic valve area (1.41 cm2 at discharge and 1.37 cm2, 2 years postoperative, p = 0.04). The expansion of the middle portion of the LOTUS valves was attributed to the increase in the aortic valve area. In conclusion, this study demonstrated the greater late-phase expansion and better valve performance of mechanically expanding valves.

Predictors and clinical outcomes of poor symptomatic improvement after transcatheter aortic valve replacement.

OBJECTIVE: Transcatheter aortic valve replacement (TAVR) improves clinical symptoms in most patients with severe aortic stenosis (AS). However, some patients do not benefit from the symptom-reducing effects of TAVR. We assessed the predictors and clinical outcomes of poor symptomatic improvement (SI) after TAVR. METHODS: A total of 1749 patients with severe symptomatic AS undergoing transfemoral TAVR were evaluated using the Japanese multicentre TAVR registry. Poor SI was defined as readmission for heart failure (HF) within 1 year after TAVR or New York Heart Association (NYHA) class ≥3 after 1 year. A logistic regression model was used to identify predictors of poor SI. One-year landmark analysis after TAVR was used to evaluate the association between poor SI and clinical outcomes. RESULTS: Among the overall population (mean age, 84.5 years; female, 71.3%; mean STS score, 6.3%), 6.6% were categorised as having poor SI. Atrial fibrillation, chronic obstructive pulmonary disease, Clinical Frailty Scale ≥4, chronic kidney disease and moderate to severe mitral regurgitation were independent predictors of poor SI. One-year landmark analysis demonstrated that poor SI had a higher incidence of all-cause death and readmission for HF compared with SI (p<0.001). Poor SI with preprocedural NYHA class 2 had a worse outcome than SI with preprocedural NYHA class ≥3. CONCLUSIONS: Poor SI was associated with worse outcomes 1 year after the procedure. It had a greater impact on clinical outcomes than baseline symptoms. TAVR may be challenging for patients with many predictors of poor SI. TRIAL REGISTRATION NUMBER: This registry, associated with the University Hospital Medical Information Network Clinical Trials Registry, was accepted by the International Committee of Medical Journal Editors (UMIN-ID: 000020423).

Aspirin Versus Clopidogrel as Single Antithrombotic Therapy After Transcatheter Aortic Valve Replacement: Insight From the OCEAN-TAVI Registry.

BACKGROUND: Current guidelines recommend dual antiplatelet therapy for the first 1 to 6 months after transcatheter aortic valve replacement (TAVR); however, recent studies have reported better outcomes with single antiplatelet therapy than with dual antiplatelet therapy in the occurrence of bleeding events, while not increasing thrombotic events. However, no data exist about optimal single antiplatelet therapy following TAVR. METHODS: Patients who underwent TAVR between October 2013 and May 2017 were enrolled from the OCEAN-TAVI Japanese multicenter registry (Optimized Transcatheter Valvular Intervention). After excluding 1759 patients, 829 who received aspirin (100 mg/d) or clopidogrel (75 mg/d) after TAVR were identified and stratified according to the presence or absence of anticoagulation. Propensity score matching was performed to adjust the baseline characteristics between the aspirin and clopidogrel groups. Outcomes of interest were all-cause and cardiovascular deaths, stroke, and life-threatening or major bleeding within 2 years following TAVR. RESULTS: After propensity score matching, 98 and 157 pairs of patients without and with anticoagulation, respectively, were identified. Falsification end points of pneumonia, urinary tract infection, and hip fracture were evaluated, and their rates were not different between groups. All-cause deaths were not statistically different between the groups in patients with (aspirin, 17.5%; clopidogrel, 11.1%; log-rank P=0.07) and without (aspirin, 29.6%; clopidogrel, 20.1%; log-rank P=0.15) anticoagulation at 2 years post-TAVR, whereas clopidogrel was associated with a lower cardiovascular mortality at 2 years in patients with (aspirin, 8.5%; clopidogrel, 2.7%; log-rank P=0.03) and without (aspirin, 18.0%; clopidogrel, 5.2%; log-rank P=0.02) anticoagulation. CONCLUSIONS: We demonstrated that clopidogrel monotherapy was associated with a lower incidence of cardiovascular death compared with aspirin monotherapy during the 2-year follow-up after TAVR regardless of anticoagulation use. REGISTRATION: URL: https://upload.umin.ac.jp; Unique identifier: UMIN000020423.

Small Left Ventricle and Clinical Outcomes After Transcatheter Aortic Valve Replacement.

Background In patients undergoing transcatheter aortic valve replacement (TAVR), those with small left ventricle (LV) may have an increased risk of poor outcomes, because small LV is associated with low-flow (LF), left ventricular hypertrophy. However, the impact of small LV on patients undergoing TAVR remains unknown. Methods and Results We examined 2584 patients who underwent TAVR between October 2013 and May 2017 using data from the Japanese multicenter registry. On the basis of the American Society of Echocardiography guidelines, small LV was defined as left ventricular end-diastolic dimension <42.0 mm for men or <37.8 mm for women. The 2-year clinical outcomes were compared between patients with and without small LV using multivariable Cox regression analyses and propensity score matching. Subgroup analyses by LF, left ventricular hypertrophy were performed. Of 2584 patients who underwent TAVR, 466 (18.0%) had small LV. Patients with small LV had smaller body size and less comorbidity, and were more likely to have LF status compared with those without. Small LV was associated with a higher 2-year all-cause (20.8% versus 14.3%; adjusted hazard ratio [HR],1.58 [95% CI, 1.20-2.09]; P=0.0013) and cardiovascular mortality (8.8% versus 5.5%; adjusted HR, 1.93 [95% CI, 1.25-2.98]; P=0.0028). Propensity score matching analysis showed consistent findings. In subgroup analyses, LF, left ventricular hypertrophy did not interact with small LV. Conclusions Small LV, determined by a simple echocardiographic parameter, was associated with poorer clinical outcomes after TAVR regardless of LF, left ventricular hypertrophy. LV size may be useful for assessing clinical outcomes after TAVR. Registration URL: https://www.umin.ac.jp/ctr/index.htm; Unique identifier: UMIN000020423.

Transcatheter aortic valve replacement with Evolut R versus Sapien 3 in Japanese patients with a small aortic annulus: The OCEAN-TAVI registry.

OBJECTIVES: To compare safety, efficacy, and hemodynamics of transfemoral transcatheter aortic valve replacement (TAVR) using self-expanding and balloon-expandable transcatheter heart valves (THVs) in patients with a small aortic annulus. BACKGROUND: Few studies have directly compared TAVR outcomes using third-generation THVs, focusing on patients with small aortic annuli. METHODS: In a multicenter TAVR registry, we analyzed data from 576 patients with a small annulus and who underwent transfemoral TAVR using third-generation THVs. Propensity score matching was used to adjust baseline clinical characteristics. RESULTS: The device success rate in the overall cohort was 92.0% (Evolut R: 92.1% vs. Sapien 3:92.0%, p = 0.96). One year after TAVR, patients treated with Evolut R maintained a lower mean pressure gradient (mPG) and a higher indexed effective orifice area (iEOA) in the matched cohort {mPG: 9.0 [interquartile range (IQR): 6.0-11.9] vs. 12.0 [IQR: 9.9-16.3] mmHg, p < .001; iEOA: 1.20 [IQR: 1.01-1.46] vs. 1.08 [IQR: 0.90-1.28] cm2 /m2 , p < .001}. However, no significant differences were reported in the incidence of severe prosthesis-patient mismatch and aortic regurgitation at 1 year. Furthermore, both groups showed comparable outcomes with no differences in terms of all-cause mortality (log-lank test, p = .81). CONCLUSIONS: TAVR for patients with a small annulus using third-generation THVs was associated with high device success. Evolut R seems to be superior to Sapien 3 in hemodynamic performance for patients with a small annulus and body surface area up to 1 year after TAVR. Nevertheless, all-cause mortality at 1 year was similar between both groups.

Impact of beta blockers on patients undergoing transcatheter aortic valve replacement: the OCEAN-TAVI registry.

OBJECTIVE: There is paucity of data on optimal medical treatment, including use of beta blockers for patients undergoing transcatheter aortic valve replacement (TAVR). The study aimed to investigate the association of beta blockers and clinical outcomes following TAVR. METHODS: We examined data of 2563 patients who underwent TAVR between October 2013 and May 2017 obtained from a prospective multicentre cohort registry, the optimised catheter valvular intervention-TAVI registry. We compared the 2-year cardiovascular and non-cardiovascular mortality and in-hospital outcomes between patients with and without preprocedural beta-blocker administration by propensity score matching (PSM). RESULTS: Preprocedural beta blockers were prescribed in 867 patients (33.8%). After PSM, the incidence of in-hospital congestive heart failure was significantly lower in patients with preprocedural beta blocker (p=0.046). No differences were found in 2-year cardiovascular and non-cardiovascular mortality. In the subgroup analyses, beta-blocker administration was associated with a lower cardiovascular mortality within 2 years in patients with a history of coronary artery bypass grafting (CABG; log-rank p=0.017), presence of peripheral artery disease (PAD; log-rank p=0.003) and brain natriuretic peptide (BNP) ≥400 pg/mL (log-rank p=0.003). When stratified by postprocedural left ventricular ejection fraction (post-LVEF), beta-blocker administration was associated with a lower cardiovascular mortality among patients with post-LVEF <50% (log-rank p=0.024). CONCLUSIONS: Preprocedural beta-blocker administration was not associated with 2-year cardiovascular and non-cardiovascular mortality in overall, but was associated with a lower 2-year cardiovascular mortality in patients with a history of CABG, presence of PAD, BNP ≥400 pg/mL and post-LVEF <50%. The findings must be validated using randomised trials.

Update on the clinical impact of mild aortic regurgitation after transcatheter aortic valve implantation: Insights from the Japanese multicenter OCEAN-TAVI registry.

OBJECTIVES: This study aimed to compare the clinical impact of mild postprocedural aortic regurgitation (post-AR) to that of none-trivial post-AR after transcatheter aortic valve implantation (TAVI) and to identify the vulnerability factors to mild post-AR. BACKGROUND: Moderate-severe post-AR, associated with increased mortality, is an important issue. However, the clinical impact of mild post-AR remains controversial. METHODS AND RESULTS: We analyzed data from 1,572 consecutive patients (1,026 of none-trivial post-AR and 546 of mild post-AR) obtained from the Optimized transCathEter vAlvular Intervention (OCEAN-TAVI) Japanese multicenter registry. We evaluated the 1-year cumulative cardiovascular death and re-hospitalization rates for heart failure (HF) after TAVI according to the degree of post-AR. Kaplan-Meier curves showed no significant difference between "none-trivial post-AR" and "mild post-AR" in terms of cardiovascular death, but a significant difference was noted in the cumulative incidence of re-hospitalization for HF between the two groups (hazard ratio 1.57, 95% confidence interval 1.02-2.41, p = .04). In the stratified analysis, only in patients with not more than 50% of left ventricular ejection fraction (LVEF), concentric left ventricular hypertrophy (LVH), and none-trivial pre-procedural aortic regurgitation (pre-AR), mild post-AR resulted in a higher incidence of re-hospitalization for HF. CONCLUSIONS: In this study, the clinical impact of mild post-AR compared to none-trivial post-AR tended to be augmented in the presence of reduced LVEF, concentric LVH, and none-trivial pre-AR. Pre-procedure echocardiographic findings including LVEF, left ventricular geometry, and pre-AR may help to judge the necessity of postdilatation in case of mild post-AR just after the bioprosthesis deployment.