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Objectives The aim of this study was to compare outcomes among transfemoral (TF), transaortic (TAo), and transapical (TA) transcatheter aortic valve replacement (TAVR). Background Very few studies have investigated the differences among TF, TAo, and TA TAVR in terms of safety and feasibility. Methods Between January 2011 and December 2014, 467 consecutive cases of TF TAVR, 289 cases of TAo TAVR, and 42 cases of TA TAVR were analyzed. Baseline characteristics, procedural characteristics, and outcomes were compared between TF and TAo and between TAo and TA approaches. Results Balloon-expandable prostheses were used in 320 cases of TF TAVR (69%), 209 cases of TAo TAVR (72%), and all cases of TA TAVR. The remaining cases were performed using self-expandable prostheses. Patient age and Society of Thoracic Surgeons score were similar (83.8 years vs. 83.7 years vs. 81.3 years and 6.2% vs. 5.8% vs. 7.1%) among all groups. Although nonsignificant, a trend toward lower 30-day mortality (5% vs. 9%; p = 0.057) was observed with TF TAVR compared with TAo TAVR. Kaplan-Meier analysis revealed a trend toward a higher 1-year survival rate (log-rank p = 0.067) with TF TAVR compared with TAo TAVR. There was no significant difference in 30-day mortality between TAo and TA TAVR (9% vs. 14%; p = 0.283). Kaplan-Meier analysis revealed a trend toward a higher 1-year survival rate (log-rank p = 0.154) with TAo TAVR compared with TA TAVR. Conclusions Although the 30-day mortality and 1-year survival rates were similar between TF and TAo TAVR patients, a trend in favor of the TF approach was observed. In addition, the TAo approach can be considered as an alternative to the TA approach when the TF approach seems unsuitable.

Objectives The aim of this study was to determine the impact of pre-existing right bundle branch block (RBBB) on clinical outcomes after transcatheter aortic valve replacement (TAVR). Background The impact of pre-existing RBBB on clinical outcomes after TAVR is unknown. Methods Between October 2013 and August 2015, 749 patients undergoing TAVR using the Edwards SAPIEN XT prosthesis were prospectively enrolled in the OCEAN-TAVI (Optimized Transcatheter Valvular Intervention) registry from 8 Japanese centers. Electrocardiograms were obtained at baseline. After the procedure, follow-up outpatient visits or telephone interviews were conducted at 30 days, 6 months, and yearly. Results A total of 102 patients (13.6%) had pre-existing RBBB. The incidence of new pacemaker implantation was significantly higher in the RBBB group (17.6% vs. 2.9%; p Conclusions Patients with RBBB demonstrated an increased risk for cardiovascular mortality after TAVR, and patients with RBBB and without pacemakers were at higher risk for cardiac death early after discharge. Patients with prior RBBB should be carefully monitored after undergoing TAVR.

Underfilling or overfilling of balloon-expandable transcatheter heart valves (THVs) during transcatheter aortic valve implantation (TAVI) is commonly used to improve conformity to small or calcified annuli in order to avoid serious complications. However, little is known about this technique. This study assessed the effects of underfilling and overfilling of THVs.Data from 213 consecutive TAVI patients treated with balloon-expandable THVs in 4 Japanese centers between October 2013 and December 2014 were prospectively analyzed; 23-mm and 26-mm THVs were implanted in 96 cases (56 underfilling, 22 nominal filling, and 18 overfilling) and 38 cases (23 underfilling and 15 nominal filling), respectively. Pre/postprocedural multidetector computed tomography (MDCT) and echocardiographic data were compared. MDCT revealed that the minimum area of the underfilled 23-mm THVs was significantly decreased compared to that of nominal filled and overfilled THVs (308.3 SD 26.1 vs. 333.9 SD 14.7 vs. 347.8 SD 21.3mm(2), respectively, p0.0001); analogous results were demonstrated for underfilled 26-mm THVs compared to nominal filled THVs (386.2 SD 34.6 vs. 423.6 SD 17.3mm(2), respectively, p=0.0004). The postprocedural transvalvular gradient of underfilled 23-mm THVs was significantly higher than that of nominal filled and overfilled THVs, while there were no differences for 26-mm THVs.Underfilling or overfilling of THVs is safe and feasible, conforming to the original annulus and covering a continuous range of annular sizes with limited THV size options. However, care should be taken when underfilling 23-mm THVs due to the potential for increased transvalvular gradient.

Objectives This study aimed to assess the feasibility of percutaneous arterial access site closure after percutaneous transfemoral transcatheter aortic valve implantation (TF-TAVI) using single versus double Perclose ProGlide devices. Backgrounds Although suturing with the preclose technique has been widely adopted during TF-TAVI, the optimal vascular closure strategy is still under debate. Methods Data from 279 patients who underwent TF-TAVI, obtained from the Optimized CathEter vAlvular iNtervention (OCEAN-TAVI) Japanese multicenter registry. Technical, procedural, and clinical outcomes were compared between the single ProGlide group (n = 99) and double ProGlide group (n = 180). They were also analyzed by propensity adjusted matching model (single [n = 69] vs. double [n = 69]). All patients were treated through a 16-Fr to 20-Fr eSheath. Technical success of the closure device was defined as hemostasis not requiring alternative invasive treatment. Access site-related vascular complications, bleedings, and other procedural complications were defined according to the Valvular Academic Research Consortium-2 (VARC-2) criteria. Results The rates of technical success and access site-related vascular complications were similar in the 2 groups (94.9% vs. 91.6%, p = 0.44; 5.0% vs. 7.7%, p = 0.54, respectively). The prevalence of bleeding complications did not differ between the 2 groups (1.0% vs. 3.3%, p = 0.43). Thirty-day mortality rate also showed no difference between the 2 groups (2.0% vs. 1.1%, p = 0.95), although these events were not associated with access site failure. These results were not attenuated in the propensity matching model. Conclusions Vascular closure with a single ProGlide in TF-TAVI could achieve equivalent, acceptable rates of technical success and procedural complications compared with the double ProGlide technique. © 2016 Wiley Periodicals, Inc.

To evaluate the effectiveness of CT before TAVI using variable helical pitch (VHP) scanning and its diagnostic performance for coronary artery disease (CAD). Sixty patients (84.4 ± 4.6 years) scheduled for TAVI underwent CT using VHP scanning with the contrast material (CM) volume calculated as scanning time × weight [kg] × 0.06 mL. Retrospective electrocardiography (ECG)-gated scanning was utilized to examine the thorax, and non-ECG-gated scanning of the abdomen immediately followed. We analyzed CT attenuation values of the coronary arteries, aorta, iliac and femoral arteries. The coronary CT angiography images were evaluated for the presence of stenosis (≥50 %); invasive coronary angiography served as a reference standard. The average attenuations of all of the arteries were greater than 400 HU. We could evaluate the peripheral access vessels and dimensions of the ascending aorta, aortic root, and aortic annulus in all patients. The average volume of CM was 38.7 ± 8.5 mL. On per-patient and vessel analysis, CT showed 91.7 % and 89.5 % sensitivity, and 91.3 % and 97.4 % negative predictive value (NPV). CT using VHP scanning with an average CM volume of 38.7 mL is useful before TAVI and had a high sensitivity and NPV in excluding obstructive CAD. • TAVI-planning CT using variable helical pitch (VHP) scanning is useful. • The average volume of contrast material was 38.7 ± 8.5 mL. • The average attenuations of all the arteries were >400 HU. • This CT had a high sensitivity and NPV for excluding obstructive CAD.

Objective To evaluate the clinical benefit of pre-procedural antiplatelet therapy in patients undergoing transfemoral (TF) transcatheter aortic valve implantation (TAVI). Methods OCEAN (Optimized transCathEter vAlvular interveNtion)-TAVI is a prospective, multicentre, observational cohort registry, enrolling 749 patients who underwent TAVI from October 2013 to August 2015 in Japan. We identified 540 patients (median age 85 years, 68.1% female) undergoing TF-TAVI; of these, 80 had no pre-procedural antiplatelet therapy and 460 had antiplatelet therapy. The endpoints were any bleeding (life-threatening, major, and minor bleeding) and thrombotic events (stroke, myocardial infarction, and valve thrombosis) during hospitalisation. Results Patients with dual antiplatelet therapy (DAPT) had a significantly higher incidence of any bleeding than those with single antiplatelet therapy (SAPT) (36.5% vs 27.5%, p=0.049) and no antiplatelet therapy (36.5% vs 21.3%, p=0.010). Patients without pre-procedural antiplatelet therapy did not experience an increased risk of thrombotic events. In multivariable logistic regression analysis, DAPT before TF-TAVI significantly increased any bleeding compared with SAPT (OR 2.05, 95% CI 1.16 to 3.65) and no antiplatelet therapy (OR 2.30, 95% CI 1.08 to 4.90). Conclusions The current study demonstrated that DAPT before TF-TAVI increased the risk of bleeding compared with single or no antiplatelet therapy. Lower intensity antiplatelet therapy was not associated with thrombotic events. In modern practice, it might be reasonable to perform TAVI using single or no pre-procedural antiplatelet therapy with an expectation of no increase of adverse events. Trial registration number UMIN-ID; 000020423; Results.

The aim of this study was to evaluate postprocedural and midterm outcomes of transcatheter aortic valve implantation (TAVI) in patients with aortic stenosis and active cancer. From October 2013 to August 2015, a total of 749 patients undergoing TAVI using the Edwards Sapien XT prosthesis (Edwards Lifesciences, Irvine, California) were prospectively included in the OCEAN-TAVI registry from 8 Japanese centers. A total of 47 patients (44.7% men; median age 83 years) had active cancer. The transfemoral approach was implemented in 85.1% of patients in the cancer group and 78.1% in the noncancer group (p = 0.22). The occurrence of major vascular complication (4.3% vs 7.5%, p = 0.24), life-threatening bleeding (2.1% vs 7.1%, p = 0.15), and major bleeding (8.5% vs 13%, p = 0.38) was similar between the cancer and noncancer groups. No significant differences were observed regarding device success (100% vs 96.2%, p = 0.17) or 30-day survival (95.7% vs 97.3%, p = 0.38). No difference in midterm survival was found between the patients with cancer and without cancer (log-rank, p = 0.42), regardless of advanced or limited cancer (log-rank, p = 0.68). In a multivariable Cox proportional hazard regression analysis, cancer metastasis was one of the most significant predictors of late mortality (hazard ratio 4.73, 95% CI 1.12 to 20.0; p = 0.035). In conclusion, patients with cancer with severe aortic stenosis who underwent TAVI had similar acute outcomes and midterm survival rates compared with patients without cancer. Cancer metastasis was associated with increased mortality after TAVI.

ObjectiveThere 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.MethodsWe 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).ResultsPreprocedural 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 ConclusionsPreprocedural 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

Ventricular-arterial coupling (VAC), calculated from the pressure-volume loops, is non-invasively estimated using blood pressure and echocardiographic parameters. VAC has been shown to be prognostic important in patients with heart failure (HF) but not previously evaluated in the patients who

Atrial fibrillation (AF) is a common comorbidity of patient undergoing transcatheter aortic valve replacement (TAVR), but the optimal antithrombotic regimen in this population remains unclear. The aim of our study was to investigate the safety and efficacy profile of direct oral anticoagulants (

Data of polyvascular disease on clinical outcome in patients undergoing transcatheter aortic valve implantation (TAVI) is scarce. In OCEAN TAVI registry (2588 patients enrolled), pre-screening lower extremity artery disease (611 patients), coronary artery disease (954 patients) and carotid/

AIMS: The aim of the study was to report the clinical experience, 30-day mortality and acute outcomes of patients undergoing transcatheter aortic valve implantation (TAVI) in the Asia Pacific region. METHODS AND RESULTS: The Asia Pacific TAVI registry is an international, multicentre, prospective, observational registry managed under the auspices of the Asian Pacific Society of Interventional Cardiology (APSIC). Patients undergoing TAVI in seven centres from Hong Kong, Japan, Philippines, Singapore and Taiwan, treated with TAVI devices for severe symptomatic aortic stenosis, were assessed. This first review presents the acute results and 30-day mortality. A multivariable analysis was also performed to identify independent predictors of early all-cause mortality. The enrolment was from 2009 to 2017 and a total of 1,125 patients were recruited. The 30-day mortality rate was 2.5%. Baseline logistic EuroSCORE more than 16 was independently associated with a 2.8-times increased risk of 30-day all-cause mortality (p=0.016). Post-procedural stroke (HR 4.9, p=0.008) was also associated with increased mortality. CONCLUSIONS: This initial report of the Asia Pacific TAVI registry demonstrated good acute success and low 30-day mortality. The preprocedural logistic EuroSCORE and post-procedural stroke incidence were strongly associated with acute mortality. Further attempts to reduce post-procedural stroke should be explored.

Background The PROTECT AF and PREVAIL trials demonstrated that the WATCHMAN left atrial appendage (LAA) closure device is a reasonable alternative to warfarin therapy for stroke prevention in patients with nonvalvular atrial fibrillation (NVAF) in the USA and Europe. We conducted the SALUTE trial to confirm the safety and efficacy of the LAA closure therapy for patients with NVAF in Japan. Methods and Results: A total of 54 subjects (including 12 Roll-in) with NVAF who had a CHA2DS2-VASc score ≥2 were enrolled. All subjects were successfully implanted with the LAA closure device. No serious adverse events related to the primary procedure-safety endpoint occurred. The 2nd co-primary endpoint was a composite of all stroke, systemic embolism and cardiovascular/unexplained death. One ischemic stroke (1/42) occurred during the 6-month follow-up. The effective LAA closure rate defined as the 3rd co-primary endpoint was 100% (42/42) at both 45-day and 6-month follow-up. Conclusions The procedural safety and 6-month results from the SALUTE trial demonstrated that the LAA closure device was safe and effective, similar to the results of large-scale randomized clinical trials, and provides a novel perspective of LAA closure for Japanese patients with NVAF in need of an alternative to long-term oral-anticoagulation. (Trial Registration: clinicaltrials.gov Identifier NCT 03033134).

Pre-procedural valvuloarterial impedance (Zva) is considered as a useful predictor of mortality in patients diagnosed as having severe aortic stenosis (AS) who undergo transcatheter aortic valve implantation (TAVI). However, the prognostic significance of post-procedural Zva remains unclear. We aimed to evaluate the prognostic significance of Zva after TAVI. We retrospectively analyzed the clinical and echocardiographic data of 1004 consecutive elderly patients (median 84 years old, 27.5% men) who underwent TAVI for severe symptomatic AS. Zva was calculated after TAVI, and patients were divided into three groups based on tertile values: the high [> 3.33 (n = 335)], intermediate [2.49–3.33 (n = 334)], and low Zva groups [

We aimed to assess real-world clinical outcomes of transcatheter aortic valve replacement (TAVR) in Japan.Data are limited concerning procedural safety and valve performance following TAVR in Japanese. A program by an on-site proctor and procedure screening system was applied during TAVR introduction.We consecutively enrolled 1613 patients who underwent TAVR using data from the Optimized CathEter vAlvular iNtervention (OCEAN) Japanese registry, which consists of 14 centers. Baseline characteristics and procedural outcomes including combined early 30-day non-safety, and mortality rates were assessed among 4 groups, divided into quartiles (Q1-Q4).Most patients were women (70.4%), elderly (84.4 ± 5.1 years), and had a median Society of Thoracic Surgeons score of 6.7(4.7-9.5). The overall 30-day mortality, combined early non-safety, and cumulative 1-year mortality rates were 1.7%, 15.1%, and 11.3%, respectively. Thirty-day mortality was not affected by center experience differences divided into quartiles (1.0%, 2.0%, 2.5%, 1.5%, p = 0.404), whereas 30-day early safety was significantly improved (19.1%, 17.9%, 14.6%, 8.9%, p 0.001). Thirty-day mortality was 0% under transfemoral on-site proctor. Cox-regression multivariate analysis revealed that male sex, clinical frailty scale, New York Heart Association class, creatinine, albumin, hemoglobin, liver disease, and non-transfemoral approach were independent predictive factors of increased midterm mortality risk.Owning to the global supporting system in Japan, excellent early and midterm outcomes have been achieved to overcome the learning curve of the newly introduced TAVR procedure.

BACKGROUND Excessive daytime sleepiness (EDS) is a significant public health concern, with sleep-disordered breathing (SDB) being a common cause. However, their precise relationship in patients with cardiovascular disease (CVD) is unclear. Furthermore, whether comorbid psychological disorders could contribute to EDS remains unknown. We aimed to assess the prevalence of EDS and its related factors, including SDB and depression, in patients with CVD.Methods and Results:We analyzed data from 1,571 patients admitted for various CVDs in a single university hospital (median age, 67 [56-76] years; 29.6% women). We assessed EDS using the Japanese version of the Epworth Sleepiness Scale (ESS; median 6.0 [4.0-9.0]). The presence of EDS (ESS >10, n=297 [18.9%]) did not differ between patients with and without SDB, which was screened with nocturnal pulse oximetry. In contrast, the patients with EDS had higher depression scores (Hospital Anxiety and Depression Scale subscore for depression [HADS-D] and Patient Healthcare Questionnaire [PHQ]-9). The depression scores, measured by HADS-D (odds ratio [OR] 1.14; 95% confidence interval [CI], 1.07-1.22) and PHQ-9 (OR, 1.14; 95% CI, 1.07-1.20) were independent determinants of EDS. These relationships among EDS, SDB, and depression were consistent among the subgroups with cardiovascular comorbidities. CONCLUSIONS The presence of EDS is associated with depressive symptoms, but not with SDB, in patients with CVD, suggesting that these patients should be thoroughly assessed for psychological disturbances.

Background Transcatheter aortic valve implantation (TAVI) is an alternative therapy for surgically high-risk patients with severe aortic stenosis (AS). Although TAVI improves survival of patients with severe AS, the mechanism of this effect remains to be clarified. We investigated the effects of TAVI on left ventricular (LV) function and identified the predictive parameters for cardiac events after TAVI. Methods and results We studied 128 patients with severe symptomatic AS who underwent TAVI. Echocardiographic assessments were performed before and after TAVI. In addition to the conventional echocardiographic parameters such as LV ejection fraction (LVEF) and LV mass index (LVMI), the LV global longitudinal strain (GLS) and early diastolic peak strain rate (SR_E) using two-dimensional speckle tracking echocardiography were also evaluated. All patients were assessed for clinical events including major adverse cardiac events and stroke according to Valve Academic Research Consortium-2 criteria. GLS, early diastolic peak velocity (e'), aortic regurgitation (AR) severity, and SR_E were significantly improved after TAVI. Thirteen patients had an event during the observational period of 591 days (median). Patients with events had higher LVMI, more severe AR, and worse GLS compared to those without events. Furthermore, receiver-operating curve analysis revealed that GLS was the strongest predictor for clinical events (p = 0.009; area under the curve, 0.73). Conclusion Preoperative LV geometric deformation and dysfunction, as a consequence of the cumulative burden of pressure overload, improved after TAVI and could predict cardiac events after TAVI.

There is limited data on hospital readmissions following transcatheter aortic valve implantation (TAVI). The aim of this study was to investigate hospital readmissions post-TAVI.Data from the Optimized transCathEter vAlvular iNtervention (OCEAN-TAVI) multicenter registry (registration no. UMIN000020423) were collected from 1215 patients who underwent TAVI. Incidence, timing, causes, and predictors of readmission in addition to the impact on patient outcomes were analyzed.Of 1215 patients, 223 (18.4%) were readmitted within 1 year post-TAVI. Early readmission (≤30 days) occurred in 42 patients, while late readmission (30 days) occurred in 181 patients. Readmissions were due to cardiac disorders, such as heart failure and arrhythmia, in 77 patients and non-cardiac disorders, such as respiratory disorders, infections, and cerebrovascular events, in 146 patients. Kaplan-Meier analysis revealed that early readmission was associated with a lower 1-year survival compared to non-early readmission (72.4% vs. 89.0%, p 0.05). Multivariate Cox regression analysis showed that acute kidney injury (hazard ratio [HR], 2.27; p = 0.03) was an independent predictor of early readmission, while anemia (HR, 2.21; p 0.01), hypoalbuminemia (HR, 1.37; p = 0.04), atrial fibrillation (HR, 1.70; p 0.01), and more than mild postprocedural aortic regurgitation (HR, 1.62; p 0.01) were independent predictors of late readmission.Readmission occurred in approximately one-fifth of patients post-TAVI and was associated with poor patient outcomes. Early readmission was mainly due to procedural complications, while late readmission was mainly determined by baseline comorbidities including a frailty criterion. Measures should be taken to reduce hospital readmissions and improve patient outcomes post-TAVI.

The relation between C-reactive protein (CRP) level on admission and mortality after transcatheter aortic valve implantation (TAVI) remains unclear. To evaluate the impact of serum CRP level on mortality after TAVI, we assessed 1,016 patients with CRP who underwent TAVI and 538 patients with high-sensitive CRP (hs-CRP) level who underwent TAVI on admission in the OCEAN (Optimized Transcatheter Valvular Intervention)-TAVI registry. Study population was stratified into 2 groups (high/low), according to the median of CRP and hs-CRP on admission. We assessed the impact of high CRP and hs-CRP level on all-cause death after TAVI. During 2-year follow-up, all-cause death after TAVI was 9.4% in patients with CRP and 11.9% in patients with hs-CRP. Median value of serum CRP was 0.10 mg/dl in both CRP and hs-CRP. Patients with high CRP (>0.10 mg/dl) had significantly higher incidence of all-cause death compared with those with low CRP (11.5% vs 7.6%, log-rank p = 0.015). Multivariate Cox regression analysis with a time-varying covariate demonstrated that high CRP was an independent predictor of all-cause death within the first 3 months (hazard ratio 2.78, 95% CI 1.30 to 5.95) compared with from 3 months to 2 years (hazard ratio 0.80, 95% CI 0.47 to 1.36) (P for interaction = 0.008). Inversely, these results were not observed in the stratification using hs-CRP on admission. In conclusion, high CRP on admission was significantly associated with an increased risk of all-cause death after TAVI, particularly within the first 3 months after TAVI. Risk stratification using CRP may be a simple and useful strategy to identify high-risk patients who undergo TAVI.

A 92-year-old woman with a history of patent ductus arteriosus (PDA) was referred to our hospital because of worsening dyspnea, with New York Heart Association classification IV. She had 3 admissions because of congestive heart failure within a year. A 12-lead ECG showed atrial fibrillation, and a chest radiograph showed severe pulmonary congestion and cardiomegaly (Figure [A]). The plasma B-type natriuretic peptide level was 4527.9 pg/mL. The echocardiogram showed a reduced ejection fraction of 39% and moderate to severe aortic valve stenosis (peak velocity=3.9 m/s; mean pressure gradient=29 mm Hg; aortic valve area=0.83 cm2). The reconstructed 3-dimensional computed tomography (CT; Ziostation2; Ziosoft Inc, Tokyo, Japan) revealed a 50-mm thoracic aortic aneurysm and a large PDA (Krichenko type A, 4.7 mm of the pulmonary artery side) with severe calcifications surrounding it (Figure B–D; Movies I and II in the Data Supplement). Because of her refractory heart failure despite treatment with intravenous furosemide and dobutamine, we decided to perform a transcatheter occlusion of PDA 8 days after her admission to the hospital. For the transcatheter occlusion procedure, we …

Cognitive impairment is common in patients underwent transcatheter aortic valve implantation (TAVI) and might affect procedure outcomes. This study evaluated the incidence of preprocedural cognitive impairment and its impact on clinical outcomes after TAVI. We analyzed the data of 1,111 patients (age ≥70 years) obtained from the Optimized CathEter vAlvular iNtervention (OCEAN-TAVI) registry. The cognitive performance of all patients was assessed using the Mini-Mental State Examination (MMSE) at baseline. We evaluated the 1-year cumulative mortality after TAVI according to the MMSE performance. Cognitive impairment was present in 420 (38%) of 1,111 patients. Compared with patients with normal cognition, those with cognitive impairment showed higher cumulative all-cause and noncardiovascular mortality rates at 1 year (14% vs. 8%, p = 0.001; 11% vs. 5%, p0.001, respectively). Moreover, cognitive impairment increased the risk of mortality from sepsis (2% vs. 0.4%; hazard ratio, 4.2; 95% confidence interval, 1.3 to 13.5; p = 0.02). In adjusted models, cognitive impairment was an independent risk factor for 1-year all-cause mortality (adjusted hazard ratio, 2.1; 95% confidence interval, 1.1 to 4.0; p = 0.02). Although patients with cognitive impairment had more in-hospital adverse outcomes, including prolonged hospital stays, major bleeding and vascular complications, and acute kidney injury, than did those with normal cognition, the 30-day mortality was similar between the groups (1% in the two groups; p0.99). In conclusion, cognitive impairment based on the MMSE score was an independent predictor of mortality at 1 year after TAVI.

Backgrounds To facilitate the learning process of transcatheter aortic valve implantation (TAVI) in Japan, unique supporting systems (e.g., on-site proctor and web-based screening systems) have been developed. Nevertheless, little is known about real-world clinical outcomes after TAVI in Japan compared with their European counterparts. Methods From the optimized catheter valvular intervention (OCEAN-TAVI, Japan) and the Institut Cardiovasculaire Paris Sud (Massy, France) registries, we evaluated a total of 134 and 178 patients, respectively, who underwent transfemoral TAVI during the same time period. Results Among the French cohort, about half of the patients (N = 81, 45.5%) were treated with the Edwards SAPIEN XT. Body surface area was significantly smaller in the Japanese cohort, although operative risks for both cohorts were almost the same. A greater percentage of patients in the Japanese cohort were implanted with 23 mm valves compared with the French cohort (73.1% vs. 23.0%, P

Transcatheter aortic valve implantation (TAVI) is a relatively mature technique that is generally accepted as a promising treatment for inoperable patients and those who are high-risk candidates for surgical aortic replacement. Although severe complications in the aortic valve complex, such as annular or aortic root rupture, are not frequently observed, these events could easily lead to catastrophic outcomes, and therefore remain major issues during TAVI. However, there remains a paucity of data describing these catastrophic complications because of their low incidence. We encountered the case of an 88-year-old woman complicated by a dissection of the ascending aorta during TAVI from an "unusual" cause: injury due to the delivery of a balloon-expandable valve to a very narrow and heavily calcified sinotubular junction (STJ). This is the first report to demonstrate the mechanism of this complication; even a delivery balloon, not a stent frame, with low inflation pressure might injure a narrow STJ and lead to an aortic dissection. Therefore, the use of oversized delivery balloons should be avoided in patients with a narrow and calcified STJ. © 2015 Wiley Periodicals, Inc.

Background Few data are available about whether aortic root calcification may impact the outcomes after transcatheter aortic valve implantation (TAVI). Objectives This study sought to evaluate the impact of aortic root calcification volume on clinical outcome after TAVI with balloon expandable Edwards Sapien XT valve (Edwards Lifesciences, Irvine, California). Methods A total of 162 TAVI patients (aged 84.0 [Interquartile Range (IQR) 81.0–84.0] years, Logistic EuroSCORE 14.5 [IQR 9.8–25.1]) with preprocedural MDCT were studied. Aortic root calcification volume was measured by MDCT image and using the dedicated software for aortic valve assessment (the automated 3mensioTM Valves 5.1, sp1, 3mensio Pie Medical Imaging BV, Maastricht, the Netherlands). A valve calcification index (VCI) was defined as calcification volume (mm3)/body surface area (mm2). Results VCI was significantly higher among patients with 30-day mortality. A VCI threshold of 517.4 (area under the curve 0.69, 95% CI 0.50–0.87, P = 0.03) predicted a higher incidence of annulus rupture (9.1 vs. 0.9%, P = 0.02) and cardiac tamponade (12.7 vs. 1.9%, P

Background Postprocedural paravalvular leak (PVL) ≥ 2 has been shown to be associated with worse outcomes after transcatheter aortic valve implantation (TAVI). This study sought to identify predictive factors of postprocedural PVL ≥ 2 after TAVI with the Edwards valve. Methods and Results A total of 176 patients with Edwards TAVI (aged 83.4 ± 7.4 years, Logistic EuroSCORE [the Logistic European System for Cardiac Operative Risk Evaluation] 18.8 ± 12.0, transfemoral 54.5%) who had preprocedural multidetector computed tomography (MDCT) were studied. A PVL ≥ 2 was observed in 12.5% of cases. By multivariate analysis, only the valve calcification index (VCI) defined as aortic root calcification volume/body surface area (odds ratio [OR] = 1.002, 95% confidence interval [CI] = 1.001–1.004, P = 0.006) and the valve diameter/the calculated average annulus diameter (CAAD) by MDCT (OR = 0.683, 95% CI = 0.474–0.984, P = 0.041) were identified as independent predictors of postprocedural PVL ≥ 2. A score predicting postprocedural PVL ≥ 2 (PVL score) was determined by allotting one point when the valve diameter/CAAD ratio was 418.4 mm3/m2, and summing all points accrued. Area under receiver-operator characteristic curves of PVL score was 0.71 (95% CI = 0.59–0.83, P

Background The efficacy and safety of transcatheter aortic valve implantation (TAVI) in Asian populations were unknown. The purpose of this study was to compare directly the clinical outcomes of the first Japanese trial and a European single-center experience after TAVI. Methods and results Between April 2010 and October 2011, 64 patients were included in the PREVAIL JAPAN multicenter trial which was set up to evaluate the safety and efficacy of the Edwards SAPIEN XT™ (Edwards Lifesciences, Irvine, CA, USA) in high-risk Japanese patients with severe aortic stenosis. Between March 2010 and January 2012, 237 consecutive patients treated with TAVI using the Edwards SAPIEN XT™ prosthesis at Institut Cardiovasculaire Paris Sud were prospectively included in the Massy cohort. We compared the clinical outcomes of these two cohorts. Patients were of similar age (83.4 ± 6.6 years vs. 84.5 ± 6.1 years, p = 0.25), but logistic EuroSCORE was higher in the Massy cohort (20.2 ± 11.7% vs. 15.6 ± 8.0%, p

The Valve Academic Research Consortium-2 has defined body mass index (BMI)

Transcatheter closure of an atrial septal defect (ASD) with the Amplatzer Septal Occluder (ASO) (St. Jude Medical, St. Paul, Minnesota) is a well-established treatment strategy. Although a majority of ASDs are easy to close percutaneously, large ASDs or those with deficient aortic/superior rims are

The authors sought to investigate the prevalence, risk factors, and mid-term mortality in Asian patients with prosthesis-patient mismatch (PPM) after transcatheter aortic valve replacement (TAVR).Little information is available on PPM after TAVR in Asian patients.The authors included 1,558 patients enrolled in the OCEAN-TAVI (Optimized transCathEter vAlvular iNtervention) Japanese multicenter registry from October 2013 to July 2016 after excluding patients who died following TAVR before discharge. PPM was defined as moderate if ≧0.65 but ≦0.85 cmOf the 1,546 patients, moderate and severe PPM were observed in 138 (8.9%) and 11 (0.7%) patients, respectively. These 149 patients were included in the PPM group. The median age and body surface area were 85 years (interquartile range [IQR]: 81 to 88 years) and 1.41 mThe low prevalence of PPM and mortality at 1 year in patients with PPM after TAVR in this Japanese cohort implies that PPM is not a risk factor for mid-term mortality in Asian patients who have undergone TAVR.

We would like to thank Jin-shan and Xue-bin for their kind interest in our recent publication in Circulation. 1 Their letter highlights the importance of Clinical Frailty Scale (CFS) assessment before invasive catheter and surgical therapy. Before invasive therapy, regardless of catheter-based or surgical approaches, all patients must undergo preassessment screening to evaluate the safety of the procedure in light of patients’ comorbidities and other clinical variables. The results of the OCEAN-TAVI study (Optimized Catheter Valvular Intervention) suggest that CFS should form part of the preoperative assessment as a means to improve patient outcomes after transcatheter aortic valve replacement (TAVR). As we previously …

There are no standardized criteria for measuring patients' frailty. We examined prognosis based on four frailty markers [serum albumin level, grip strength, gait speed, and clinical frailty scale (CFS)] in patients who underwent transcatheter aortic valve replacement (TAVR) between October 2013 and April 2016 and were recorded in the Optimized CathEter vAlvular iNtervention (OCEAN) Japanese multicenter registry. Serum albumin level was assessed by dividing patients into two groups: hypoalbuminemia or non-hypoalbuminemia according to their serum albumin level. Clinical outcomes including all-cause, cardiovascular and non-cardiovascular mortality rates after TAVR were compared. During the follow-up period cumulative all-cause, cardiovascular and non-cardiovascular mortality rates were significantly higher in the hypoalbuminemia group than in the non-hypoalbuminemia group. This result remained unchanged even after a propensity-matched model was used in terms of cumulative all-cause and non-cardiovascular mortality; however, differences in cardiovascular mortality rates were attenuated. To consider the impact of grip strength patients were divided into a low or high peak grip strength group based on classification and regression tree (CART) survival analysis. The clinical outcomes for each sex were compared between the two groups. In both sexes the cumulative 1-year mortality rates were significantly different between the two groups. To investigate gait speed patients were classified into two gait speed groups (low or high gait speed group) based on CART survival analysis. Clinical outcomes were compared between the two groups. The cumulative 1-year mortality rate was significantly different between the two gait speed groups. The effect of CFS on prognosis after TAVR was assessed. Patients were categorized into five groups based on the following CFS scores: CFS1-3, CFS4, CFS5, CFS6, and CFS ≥7. We evaluated the relationship between the CFS score and other indicators of frailty markers. We also assessed the mid-term mortality among the five groups. The CFS score had a significant correlation with other frailty markers. The cumulative 1-year mortality increased with an increasing CFS score. In the Cox regression multivariable analysis, the CFS score was an independent predictive factor of an increased late cumulative mortality risk. In conclusion, the results suggest that serum albumin level, grip strength, gait speed, and CFS score are all useful indicators when considering the optimal indications and risk stratification for TAVR.

BACKGROUND Predictors of bleeding and mortality after trans femoral transcatheter aortic valve replacement (TF-TAVR) has not been thoroughly investigated. OBJECTIVE The aim of this study was to assess whether Hypertension, Abnormal renal/liver function, Stroke, Bleeding history or predisposition, Labile INR, Elderly, Drugs/alcohol concomitantly (HAS-BLED) score has predictive value for bleeding and mortality in patients after TAVR. METHODS Between October 2013 and April 2016, 969 patients underwent TF-TAVI were prospectively included in the OCEAN-TAVI registry from Japan. The primary outcomes were severe bleeding (including life-threatening and major bleeding defined in The Valve Academic Research Consortium-2 criteria) and mortality within 1 year after TAVR. RESULTS Elderly (84 ± 5 years) and high surgical risk patients (The Society of Thoracic Surgery Risk Score 6.7 [4.6-9.3]) were enrolled. Severe bleeding and mortality had occurred in 177 patients (18.2%) and 66 patients (6.8%), respectively. On multivariate analysis, HAS-BLED score was associated with severe bleeding (hazard ratio [HR], 1.82; 95% confidence interval [CI], 1.41-2.00; p

Background— Gait speed reflects an important factor of frailty and is associated with an increased risk of late mortality in patients with cardiac disease. This study sought to assess the prognostic value of gait speed in elderly patients who underwent transcatheter aortic valve replacement. Methods and Results— We investigated the 5-m or 15-feet gait speed (m/sec) in 1256 patients who underwent transcatheter aortic valve implantation using data from the OCEAN-TAVI Japanese multicenter registry (Optimized Catheter Valvular Intervention–Transcatheter Aortic Valve Implantation). Baseline characteristics, procedural outcomes, and all-cause mortality were compared among groups defined by differential gait speed classification: model 1, normal (>0.83 m/sec; n=563; 44.8%), slow (0.5–0.83 m/sec; n=429; 34.2%), slowest (0.385 m/sec; n=1080 versus ≤0.385 m/sec; n=117). The cumulative 1-year mortality rate showed significant differences in the classical gait speed groups in model 1 (7.6%, 6.6%, 18.2%, and 40.7%, respectively; P P P =0.039, P =0.001). Conclusions— Gait speed using both traditional and specific classification is useful as a potential marker for predicting vulnerable patients associated with adverse clinical outcomes after transcatheter aortic valve replacement.

Background In this study, we sought to investigate the 2‐year prognostic impact of B‐type natriuretic peptide ( BNP ) levels at discharge, following transcatheter aortic valve replacement. Methods and Results We enrolled 1094 consecutive patients who underwent transcatheter aortic valve replacement between 2013 and 2016. Study patients were stratified into 2 groups according to survival classification and regression tree analysis (high versus low BNP groups). We evaluated the impact of high BNP on 2‐year mortality compared with that of low BNP using a multivariable Cox model, and assessed whether this stratification would improve predictive accuracy for determining 2‐year mortality by assessing time‐dependent net reclassification improvement and integrated discrimination improvement. The median age of patients was 85 years (quartile 82–88), and 29.2% of the study population were men. The median Society of Thoracic Surgeons score was 6.8 (4.7–9.5), and BNP at discharge was 186 (93–378) pg/mL. All‐cause mortality following discharge was 7.9% (95% CI, 5.8–9.9%) at 1 year and 15.4% (95% CI, 11.6–19.0%) at 2 years. The survival classification and regression tree analysis revealed that the discriminating BNP level to discern 2‐year mortality was 202 pg/mL, and that elevated BNP had a statistically significant impact on outcomes, with an adjusted hazard ratio of 2.28 (1.36–3.82, P =0.002). The time‐dependent net reclassification improvement ( P =0.047) and integrated discrimination improvement ( P =0.029) analysis revealed that the incorporation of BNP stratification with other clinical variables significantly improved predictive accuracy for 2‐year mortality. Conclusions Elevation of BNP at discharge is associated with 2‐year mortality after transcatheter aortic valve replacement.

Advanced chronic kidney disease (CKD) is an independent predictor of mortality in patients undergoing transcatheter aortic valve implantation (TAVI). We aimed to identify predictors of 1-year mortality in patients after TAVI stratified by the presence or absence of advanced CKD (defined as estimated glomerular filtration rate