Search

Frailty is strongly associated with poor short- and long-term prognoses in patients who undergo transcatheter aortic valve implantation (TAVI). However, limited data are available regarding the association between frailty and late bleeding events after TAVI. Of the 2,518 patients in the Japanese multicenter TAVI registry, 1371 patients with complete data on frailty parameters were analyzed. We developed a modified Essential Frailty Toolset (EFT) using 4 frailty parameters-gait speed, Mini-Mental State Examination (MMSE), anemia, and hypoalbuminemia-that are significant predictors of late bleeding events in this cohort. The predictive value of the modified EFT for late bleeding after TAVI was assessed in comparison with other clinical variables. Late bleeding events after TAVI occurred in 80 patients (5.8%). Gait speed, MMSE, anemia, and hypoalbuminemia were significantly associated with late bleeding. A modified EFT was developed to include these parameters, which were scored from 0 to 5 points comprising the following 4 items: gait speed (0:1.5 m/s, 1: 1.5 to 0.75 m/s, 2:0.75 m/s), cognition (1: MMSE18), anemia (1: hemoglobin13 g/100 ml in men or12 g/100 ml in women), and malnutrition (1: albumin3.5 g/100 ml). Multivariate Cox regression analysis revealed that the modified EFT was an independent predictor of late bleeding (adjusted hazard ratio 1.51, 95% confidence interval [CI] 1.19 to 1.92, p0.001) In conclusion, the modified EFT was found to be a significant predictive factor for late bleeding events after TAVI. Assessment of frailty is important to predict patients with high bleeding risk after TAVI.

Data regarding the incidence, predictive factors, and clinical outcomes of post-transcatheter aortic valve replacement (TAVR) bleeding is limited in the Asian cohort.This study sought to assess the predictors and prognostic impact of post-TAVR late bleeding.This study used the Japanese multicenter registry data to analyze 2,518 patients (mean age: 84.3 ± 5.2 years) who underwent TAVR. Late bleeding was defined as any postdischarge bleeding events after TAVR. Baseline characteristics, predictive factors, and clinical outcomes including death and rehospitalization were assessed in patients with and without late bleeding events.The cumulative incidence rate of all and major late bleeding and ischemic stroke were 7.4%, 5.2%, and 3.4%, respectively, 3 years after TAVR. The independent predictive factors of late bleeding were low platelet count, high score (≥4) on the clinical frailty scale, and a New York Heart Association functional class III/IV. The cumulative mortality rates up to 3 years were significantly higher in patients with late bleeding than in those without bleeding (Late bleeding after TAVR was not a rare complication, and it significantly increased long-term mortality. It should be carefully managed, especially when it is predictable in the high-risk cohort, and efforts should be taken to reduce bleeding complications even after a successful procedure.

BACKGROUND The impact of balloon post-dilatation (BPD) on short- and long-term valve performance after Sapien 3 (S3) implantation is unknown. This study aimed to evaluate the impact of balloon post-dilatation (BPD) on short- and long-term valve performance after the implantation of S3. METHODS A total of 846 patients implanted with S3 from the OCEAN-TAVI registry were included in this study. The patients were divided into BPD and non-BPD groups. The clinical outcomes and valve functions were compared. RESULTS The BPD group included 173 (20.4%) patients and the non-BPD group comprised 673 (79.6%) patients. The prosthesis-patient mismatch (PPM) rates were significantly lower in the BPD group than in the non-BPD group before and after propensity score matching at in-hospital follow-up (before matching: 12 [7.1%] vs. 108 [16.3%], p = 0.002; after matching: 8 [6.3%] vs. 19 [14.8%], p = 0.027) and at 1-year follow-up (before matching: 14 [12.5%] vs. 112 [23.6%], p = 0.010; after matching: 9 [10.5%] vs. 19 [22.1%], p = 0.039). The rates of acute kidney injury, cardiac tamponade, and in-hospital cardiovascular death were significantly higher in the BPD group than in the non-BPD group (acute kidney injury: 22 [12.7%] vs. 33 [4.9%], p < 0.001; cardiac tamponade: 3 [1.7%] vs. 2 [0.3%], p = 0.028; in-hospital cardiovascular death: 4 [2.3%] vs. 3 [0.4%], p = 0.016). After matching, these clinical outcomes were similar between the BPD and non-BPD groups. CONCLUSIONS The BPD group demonstrated better short- and long-term valve performance. Caution is needed to avoid procedure-related complications in patients undergoing BPD.

Background Dialysis patients with aortic stenosis are generally considered as being at extreme or high surgical risk. Herein, the first clinical trial was conducted to investigate clinical safety and effectiveness of transcatheter aortic valve replacement (TAVR) using the balloon-expandable transcatheter aortic valve (SAPIEN 3, Edwards Lifesciences, Irvine, CA, USA) in Japanese dialysis patients. Methods The clinical trial is a single arm, prospective, open, non-randomized, Japanese multicenter study. The primary purpose of this trial is to evaluate the efficacy and safety of TAVR using SAPIEN 3 in 28 Japanese dialysis patients. Results Mean age was 79.2 years and 67.9% were male (Mean STS score was 14.3%). Transfemoral and transapical approaches were performed in 25 (89.3%) and 3 patients (10.7%), respectively. All bioprostheses were successfully implanted. Median intensive care unit stay and hospital stay after TAVR were 1.4 days and 6.3 days, respectively. In-hospital mortality was 3.6% and freedom from all-cause mortality at 1 year was 89.3%. Disabling stroke and life-threatening bleeding at 1 year was 7.7% and 8.5%, respectively. There was no structural valve deterioration during follow-up. New York Heart Association functional status, six-minute walk test, and EuroQOL visual analogue scale score significantly improved through 1 year compared with baseline. Conclusions TAVR using SAPIEN 3 is safe and effective for the treatment of Japanese dialysis patients with symptomatic severe aortic valve stenosis.

BACKGROUND Little is known about changes in nutritional status as an index of frailty on clinical outcomes after transcatheter aortic valve replacement (TAVR). This study aimed to assess the clinical impact of serum albumin changes after TAVR. METHODS Changes in serum albumin levels from baseline to 1 year after TAVR were evaluated in 1524 patients who were classified as having hypoalbuminemia (

Heart failure (HF) is a risk factor for adverse post-procedural outcome after revascularization; however, it is unclear how left ventricular systolic dysfunction (LVSD) and clinical HF symptoms affect percutaneous coronary intervention (PCI) outcomes. We investigated the characteristics and long-term outcomes of patients with clinical HF or LVSD after PCI.This was a Japanese multicenter registry study of adult patients receiving PCI. Among 4689 consecutive patients who underwent PCI at 15 hospitals from January 2009 to December 2012, we analyzed 2634 (56.2%) with documented left ventricular ejection fraction (LVEF). They were divided into four groups based on clinical HF (symptoms or HF hospitalization) and LVEF [≥35% and35% (HF due to LVSD)]. The primary outcome was major adverse cardiovascular events (MACE), comprising all-cause death, acute coronary syndrome, HF hospitalization, performance of coronary artery bypass grafting, and stroke within 2 years after the initial PCI.Our findings revealed 354 patients (13.4%) with HF (clinical HF, n = 173, 48.9%; LVSD, n = 132, 37.3%; both, n = 49; 13.8%). The incidence of MACE was higher in patients with clinical HF or LVSD, and was largely due to higher non-cardiac death and HF hospitalization. After adjustment, clinical HF (hazard ratio 2.16, 95% confidence interval; 1.49-3.14) and lower LVEF (per 10%, hazard ratio 0.89, 95% confidence interval; 0.81-0.99) were independently associated with higher MACE risk.Clinical HF and LVSD were independently associated with adverse long-term clinical outcomes, particularly with non-cardiac death and HF readmission, in patients treated with PCI.

Background Transcatheter aortic valve implantation (TAVI) has become the main treatment for symptomatic severe aortic stenosis, but patients on dialysis have been excluded from major randomized controlled trials. Our aim was to compare mortality and procedure-related complications after TAVI in patients with end-stage renal disease (ESRD) on dialysis vs those without. Methods EMBASE and MEDLINE were searched through November 2019 to investigate the comparative outcomes between patients with ESRD on dialysis and those without who underwent TAVI. The main outcomes were short-term (30-day/in-hospital) mortality and procedural complications, and long-term (>6 months) all-cause mortality. Results Our search identified 10 observational studies enrolling 128,094 (5399 on dialysis) patients who underwent TAVI. Dialysis patients had a significantly higher rate of short-term and long-term mortality than nondialysis patients (odds ratio [95% confidential interval]: 2.18 [1.64-2.89], P Conclusion Dialysis patients had significantly higher rates of short- and long-term mortality, short-term life-threatening and/or major bleeding, permanent pacemaker implantation, and device failure compared with nondialysis patients. Careful selection of patients who would benefit from TAVI among patients with ESRD requiring dialysis is necessary to prevent high rates of postprocedural complications.

Background Cerebrovascular events (CVEs) are not uncommon complications of transcatheter aortic valve replacement (TAVR). Our study aimed to determine the predictors of peri-procedural and sub-acute CVEs following TAVR. Methods Using the Japanese multicenter registry, we evaluated 1613 patients undergoing TAVR between October-2013 and July-2016. Occurrences of 24-hour and 1- to 30-day CVEs were evaluated to clarify the predictors of CVEs following TAVR. Results The mean age was 84.4 years and mean Society of Thoracic Surgeons score was 8.3%. Overall 24-hour and 30-day CVE rates were 1.2% and 2.7%, respectively. A multivariate analysis demonstrated that independent predictor of 24-hour CVEs was index aortic valve area (iAVA) [adjusted OR (adjusted-OR), 0.001; 95% CI, 0.001–0.13; p = .005]. The receiver operator curve derived cut-off value of iAVA for the prediction of 24-hour CVEs was 0.40 cm2/m2. In contrast, independent predictors of 1- to 30-day CVEs were paroxysmal atrial fibrillation (PAF; adjusted-OR, 3.35; 95% CI, 1.36–8.27; p = .009) and iAVA after TAVR (adjusted-OR, 0.11; 95% CI, 0.02–0.66; p = .02). Consequently, independent predictors of 30-day CVEs were prior stroke (adjusted-OR, 2.18; 95% CI, 1.07–4.45; p = .03), PAF (adjusted-OR, 2.18; 95% CI, 1.05–4.56; p = .04), and prior coronary artery disease (adjusted-OR, 1.88; 95% CI, 1.01–3.48; p = .05). Conclusions Within 24 h, small iAVA impacted the increased risk of CVEs, whereas PAF and iAVA after TAVR impacted the increased risk of 1- to 30-day CVEs following TAVR. The mechanism of CVEs might differ according to onset.

The optimal management of preexisting severe aortic stenosis (AS) in patients undergoing noncardiac surgery (non-CS) remains uncertain. This study aimed to investigate the safety and effectiveness of percutaneous aortic valve intervention (PAVI) in patients with AS before non-CS.We analyzed pooled data within a multicenter Japanese registry from 118 patients with severe AS who underwent PAVI before non-CS. Sixty patients underwent percutaneous balloon aortic valvuloplasty (BAV) and 58 patients underwent transcatheter aortic valve replacement (TAVR). The groups' baseline characteristics, perioperative complications, and 30-day mortality and midterm mortality after non-CS were compared.The postprocedural mean pressure gradient was higher in the BAV group than in the TAVR group (35.0 ± 11.5 mmHg vs. 11.5 ± 4.8 mmHg, p 0.001). The non-CS operation risk did not differ between the groups (p = 0.69). One patient in each group experienced a noncardiac death (p = 0.74), and the 30-day mortality rate after non-CS was 1.7%. Heart failure occurred in 2 patients in each group (p = 0.68). One patient in the TAVR group experienced a non-disabling stroke, and no myocardial infarctions occurred. Consequently, the combined adverse events were 5.0% and 6.9% in the 2 groups (p = 0.48). The bleeding rates during the non-CS were similar in both groups (33.3% vs. 25.9%, p = 0.25). There were no differences between the groups regarding midterm mortality (p = 0.60), whereas 53.3% of the patients in the BAV group required invasive treatment of their AS during follow-up.Among patients with severe AS, PAVI before non-CS reduces the AS severity and may contribute to procedural safety during non-CS.

Nutritional condition is one marker of patients' frailty. The Geriatric Nutritional Risk Index (GNRI) is a well-known marker of nutritional status. This study sought to assess the clinical outcomes of GNRI after transcatheter aortic valve replacement (TAVR).We evaluated the GNRI value of 1,613 patients who underwent TAVR using data from a Japanese multicenter registry. According to baseline GNRI, patients were classified into 3 groups: GNRI ≥92 (n = 1,085; 67.3%), GNRI 82-92 (n = 396; 24.6%), and GNRI ≤82 (n = 132; 8.2%). Baseline characteristics, procedural outcomes, and cumulative mortality rates were compared. In addition, GNRI correlations with other frailty components (gait speed, grip strength, and Clinical Frailty Scale) and Society of Thoracic Surgeons (STS) score were also evaluated.Significantly increased mortality rates were observed across the 3 groups at 30 days (0.9%, 2.3%, and 6.8%, respectively; P .001) and 1 year (6.5%, 16.4%, and 36.4%, respectively; P .001). Both GNRI 82-92 and GNRI ≤82 (as a reference for GNRI ≥92) were independently associated with increased midterm mortality in the Cox regression multivariate model (hazard ratio: 1.97, 3.60; 95% confidence interval: 1.37-2.84, 2.30-5.64; P .001, P .001, respectively). The GNRI value was significantly correlated with gait speed (Spearman ρ = -0.15, P .001), grip strength (ρ = 0.25, P .001), Clinical Frailty Scale (ρ = -0.24, P .001), and STS score (ρ = -0.29, P .001).GNRI is related to both frailty components and the STS score and is an important surrogate marker for predicting worse clinical outcomes after TAVR. Assessment of the GNRI may be considered when deciding on TAVR.

Objectives This study aimed to analyze the prognostic impact of low-flow (LF) severe aortic stenosis in small-body patients undergoing transcatheter aortic valve replacement (TAVR). Background Western literature demonstrates a poor prognosis with paradoxical LF and low-flow low-gradient (LF-LG) severe aortic stenosis (AS), as defined by stroke volume index (SVi) Methods This was a retrospective analysis of 723 consecutive Japanese patients (median age 85 years; 32.6% male; median body surface area 1.4 m2) who underwent TAVR for severe AS at 9 sites in Japan. The primary and secondary endpoints were cumulative all-cause and cardiovascular mortality after TAVR, respectively. Results Ninety-seven (13.4%) patients had paradoxical LF severe AS whereas 38 (5.3%) had paradoxical LF-LG with severe AS. PLF was associated with a significant increase in all-cause (hazard ratio [HR]: 3.00; 95% confidence interval [CI]: 1.34 to 6.72; p Conclusions Among Japanese small-body patients with severe AS, both paradoxical LF and LF-LG severe AS were associated with poor outcomes following TAVR. SVi was an independent predictor of cardiovascular mortality after TAVR. (Optimised Transcatheter Valvular Intervention registry [OCEAN-TAVI]; UMIN000020423)

Objectives 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). Background Little information is available on PPM after TAVR in Asian patients. Methods 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 cm2/m2, or severe if Results Of 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 m2 (IQR: 1.30 to 1.53 m2), respectively. In our multivariate analysis, younger age, larger body surface area, smaller aortic valve area, smaller annulus area, no balloon post-dilatation, and use of Edwards Sapien 3 (Edwards Lifesciences, Irvine, California) were identified as independent predictors of PPM. The estimated cumulative all-cause mortality at 1 year using the Kaplan-Meier method was similar between the PPM and non-PPM groups (10.2% vs. 8.3%; log-rank; p = 0.41). Conclusions The 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.

The relationship between cardiac rhythm and adverse events after transcatheter aortic valve implantation (TAVI) remains unclear. To compare the prognostic impact of preexisting atrial fibrillation (AF) and new-onset AF (NOAF) after TAVI, we assessed 1,124 patients (846 with sinus rhythm [SR], 49 with NOAF, and 229 with preexisting AF) who underwent TAVI with a balloon-expandable valve from October 2013 to April 2016. The incidences of all-cause death and rehospitalization for heart failure (HF) were retrospectively evaluated. The median follow-up period was 370 days (range 188 to 613). In the Kaplan-Meier analysis, the incidences of all-cause death and rehospitalization for HF were significantly higher in patients with preexisting AF than those in patients with NOAF and SR. The multivariable analysis showed that preexisting AF was significantly associated with increased all-cause death (hazard ratio [HR] 1.54; 95% confidence interval [CI] 1.02 to 2.34) and rehospitalization for HF (HR 2.94; 95% CI 1.75 to 4.93). The landmark analysis demonstrated that patients with preexisting AF had a significantly higher incidence of rehospitalization for HF within the first 6 months after TAVI (HR 4.04; 95% CI 2.23 to 7.32), and a higher incidence of all-cause death from 6 months to 2 years after TAVI (HR 2.12; 95% CI 1.15 to 3.90). Our study demonstrated that preexisting AF increased the risk of all-cause death and rehospitalization for HF after TAVI in comparison with NOAF or SR. Moreover, there was a specific timing of susceptibility to all-cause death and rehospitalization for HF after TAVI.

Background There are currently only limited data focusing on transcatheter aortic valve implantation (TAVI) for bicuspid aortic valves (BAV) patients using the Edwards SAPIEN (Irvine, CA, USA) 3 (S3) valve. The aim of this study was to evaluate the feasibility and efficacy of TAVI using the S3 in patients with BAV. Methods A total of 153 TAVI cases performed with the S3 were included. BAV was detected by multidetector computed tomography (MDCT) in 10 (7%) patients. The other patients had tricuspid aortic valves (TAV). The BAV and TAV groups were compared. Results Patient age and logistic EuroSCORE were similar in the BAV and TAV groups. The calculated annulus average diameter (CAAD) by MDCT was significantly larger in the BAV group (26.5 mm vs 23.7 mm, p = 0.036) as was the annular area by MDCT (562 mm 2 vs 446 mm 2 , p = 0.033). On the other hand, the valve diameter/CAAD ratio was significantly lower in the BAV group (1.01 vs 1.06, p = 0.010) as was the annular area oversizing percentage (3% vs 11%, p = 0.033). There were no significant differences between the two groups regarding the frequency of paravalvular aortic leakage (PVL) ≥2 (0% vs 6%, p = 0.492) and the 30-day mortality rate (0% vs 1%, p = 0.799). Conclusions Although TAVI for BAV tended to be carried out with a less oversized valve compared to TAVI for TAV, the frequency of post-procedural PVL ≥2 was similarly low in the two groups. TAVI using the S3 in patients with BAV seems to be feasible.

Complications after transcatheter aortic valve implantation (TAVI) remain an important issue. This study aimed to evaluate the impact of systematic postprocedural multidetector computed tomography (MDCT) to detect subclinical complications after TAVI. From October 2013 to August 2015, a total of 135 patients who underwent transfemoral TAVI (n = 116) or transapical TAVI (n = 19) with Sapien XT and MDCT preprocedure and postprocedure were enrolled. Postprocedural MDCT findings were compared with the preprocedural MDCT findings. Cardiovascular complications were observed in 25.9% of patients, including 6 cases (4.5%) with major complications. Of those, clinically apparent major complications were reported in 2 cases including rupture of the sinus of Valsalva and iliac rupture. The complications in the remaining 4 cases (3.0%) included aortic dissection, aortic intramural hematoma, and left ventricular apical pseudoaneurysm, which were totally asymptomatic and only detected by MDCT. The apical pseudoaneurysm required surgical repair. Minor complications were observed in 21.5% of patients, 50% of which were subclinical. Only 1 case with femoral pseudoaneurysm required an additional procedure. Noncardiovascular findings were detected in 27.4% of patients; the most frequent were pleural effusions and atelectasis, which were predominantly observed in those treated through a transapical approach. Contrast-induced acute kidney injury after postprocedural MDCT was reported in 1 patient whose clinical course was complicated by sepsis. In conclusion, postprocedural MDCT was useful in detecting important subclinical complications that may affect the clinical course without deterioration of renal function.

The aim of this study was to evaluate the incidence, predictors, and outcomes of percutaneous closure device (PCD) failure during transfemoral transcatheter aortic valve implantation (TAVI) with an Edwards Sapien-XT prosthesis using an expandable sheath (eSheath). From October 2013 to April 2016, 1,215 patients who underwent TAVI were prospectively enrolled in the Optimized Transcatheter Valvular Intervention (OCEAN-TAVI) registry. Of these, 478 patients underwent transfemoral TAVI with Sapien-XT prosthesis using an eSheath and percutaneous closure with a Perclose ProGlide system. We evaluated the predictors of PCD failure and whether it affected the clinical outcomes. Patients were aged 85 years (interquartile range 82 to 88 years). PCD failure occurred in 36 patients (8%). Sheath-to-femoral artery ratio (SFAR) (per 1 increase) (odds ratio 5.40, 95% confidence interval 1.28 to 22.92, p = 0.022) predicted PCD failure in a multivariate model. The sensitivity-specificity curves identified an SFAR threshold of 1.03; the area under the curve for SFAR as a predictor of PCD failure was 0.629. The PCD failure group did not have a higher rate of 30-day mortality (0% vs 1%, p = 0.52) or mid-term (365-day) mortality (log-rank test p = 0.85) compared with the PCD success group in the Kaplan-Meier analysis. In conclusion, PCD failures occurred in 8% of the patients and were not associated with 30-day or mid-term mortality rates after percutaneous transfemoral TAVI. The SFAR threshold of 1.03 was useful for predicting PCD failures.

There are limited data regarding the influence of liver dysfunction on outcomes of transcatheter aortic valve implantation (TAVI). Model for End-stage Liver Disease eXcluding International normalized ratio (MELD-XI) score, which was originally developed for patients with cirrhosis awaiting liver transplantation, has been reported as a predictor of heart disease. The aim of this study was to investigate the prognostic value of MELD-XI score for patients undergoing TAVI.Data from the prospectively maintained Optimized transCathEter vAlvular iNtervention (OCEAN-TAVI) multicenter registry were collected in 749 patients who underwent TAVI between October 2013 and August 2015. MELD-XI score was calculated as follows: 11.76×Ln (creatinine)+5.11×Ln (total bilirubin)+9.44. Patients were categorized based on MELD-XI score10 or ≤10, and compared with regard to clinical characteristics and outcomes of TAVI.Higher MELD-XI score was associated with lower 30-day survival (95.6% vs 98.5%, P=0.03). Kaplan-Meier analysis revealed that higher MELD-XI score also was associated with lower 6-month survival (P0.01). Multivariate Cox regression analysis showed that MELD-XI score was an independent predictor of 6-month cumulative mortality. Receiver operating characteristic analysis revealed that MELD-XI score showed better accuracy in predicting 6-month mortality compared with Logistic European System for Cardiac Operative Risk Evaluation, European System for Cardiac Operative Risk Evaluation II, and Society of Thoracic Surgeons scores (area under the curve=0.67, 0.58, 0.57, and 0.60, respectively).Evaluation of liver dysfunction according to MELD-XI score provides additional risk information for patients undergoing TAVI.

Sleep-disordered breathing (SDB) or short sleep duration and coronary artery disease (CAD) are related, yet, the prevalence of SDB and short sleep duration as well as their mechanism remain unknown. Enhanced vascular inflammation is also implicated as one of the pathophysiologic mechanisms in CAD. The aims of this study were to evaluate the prevalence of patients with SDB and short sleep duration, and to examine their relationship with serum C-reactive protein (CRP) level in CAD patients.We evaluated 161 CAD patients who underwent percutaneous coronary intervention, using nocturnal pulse oximetry, a non-invasive screening method for nocturnal intermittent hypoxia. Based on three percent oxygen desaturation index (3% ODI), the patients were divided into nocturnal intermittent hypoxia (3% ODI ≥ 15; n = 45) and control groups (3% ODI 15, n = 116). The nocturnal intermittent hypoxia group had higher body mass index and serum CRP level compared with the control group. Short sleep duration (6 h, n = 45) was also associated with increased CRP level compared with the control group (≥6 h, n = 116). In multiple regression analysis, nocturnal intermittent hypoxia (β = 0.332, 95% confidence interval [CI] 0.102-0.562, P = 0.005) and short sleep duration (β = 0.311, 95% CI 0.097-0.526, P = 0.005) were both independent determinants for log serum CRP level.Nocturnal intermittent hypoxia and short sleep duration were independently associated with elevated serum CRP level in CAD patients, suggesting that both SDB and sleep shortage are associated with enhanced inflammation in CAD patients. SDB and sleep duration may be important modifiable factors in the clinical management of patients with CAD.

Transcatheter aortic valve implantation (TAVI) has become the main treatment for symptomatic, severe aortic stenosis, but patients on dialysis have been excluded from major randomized controlled trials. Our aim was to compare outcomes after TAVI of patients with end-stage renal disease (ESRD) on

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.

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.

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/

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

Hand-dominant grip strength is a simple marker that reflects frailty associated with incremental risks for late mortality. However, the prognostic value and optimal threshold of grip strength are not fully validated in elderly patients who undergo transcatheter aortic valve replacement (TAVR). The

The aim of this study was to compare the outcomes of transcatheter aortic valve implantation using the Edwards SAPIEN valve and the Medtronic CoreValve in patients with annulus of intermediate size (20 to 25 mm). From October 2008 to April 2012, 662 consecutive patients who underwent transcatheter aortic valve implantation were studied at 2 French centers. After propensity score matching, a total of 192 patients with intermediate-sized aortic annulus who had received either Edwards (n = 96, mean age 82.4 ± 7.9 years, 48% men, 61.9% receiving the 26-mm valve) or CoreValve (n = 96, mean age 82.5 ± 7.7 years, 50% men, 64.6% receiving the 29-mm valve) prostheses through the transfemoral approach were studied. Adequate reduction in postprocedural mean pressure gradients was achieved with the Edwards valve and the CoreValve (10.9 ± 4.7 vs 9.1 ± 4.4 mm Hg, respectively, p0.01). Major vascular complications (5.2% vs 3.1%, p = 0.36), device success (95.8% vs 93.8%, p = 0.52), and 30-day survival (90.6% vs 89.6%, p = 0.81) were similar. The incidence of postprocedural aortic regurgitation grade ≥2/4 and new pacemaker implantation was more frequent in the CoreValve group (14.3% vs 35.5%, p0.01, and 4.2% vs 18.8%, p0.01, respectively). There was no significant difference in 1-year cumulative survival rates in the Edwards valve group compared with the CoreValve group (80.1 ± 4.2% vs 75.6 ± 4.9%, log-rank p = 0.31). In conclusion, in patients with annulus of intermediate size, similar device success and short-term and midterm outcomes were achieved with either of the valves, irrespective of the specific complications related to each valve.

Background The prevalence of success of percutaneous coronary interventions (PCIs) of chronic total occlusions (CTOs) remains relatively low. We determined the effect of preoperative multidetector computed tomography coronary angiography (CTCA) in PCIs of CTOs. Methods The study population was 100 consecutive patients who underwent PCIs of CTOs from January 2005 to December 2007 at Keio University School of Medicine. They were divided into two groups according to the absence (non-CT group, n =60) or presence (CT group, n =40) of preoperative CTCA. The effect of preoperative CTCA was assessed in the prevalence of success of the procedure, prevalence of complications, irradiation time, and the dose of contrast agents. Results The prevalence of procedural success was similar in both groups (non-CT group vs CT group 80.0% vs 77.5%, p =0.76). Irradiation time and the dose of contrast agents were also similar between these groups. The prevalence of complications was significantly reduced in the CT group (23.3% vs 7.5%, p =0.039), especially coronary perforations, which required treatment only in the non-CT group (10.0% vs 0.0%, p =0.039). Multiple logistic regression analysis revealed that use of a rotablator (odds ratio [OR]: 4.40, 95% confidence interval [CI]: 1.19–16.27, p =0.027) and absence of preoperative CTCA (OR: 4.26, 95% CI: 1.04–17.49, p =0.044) were independent determinants of complications. Conclusion Preoperative CTCA does not affect the prevalence of procedural success, irradiation time and the dose of contrast agents, but may be useful to reduce the prevalence of complications during PCIs of CTOs.