Abstract Objectives This single-center study was performed to analyze the effect of an increased transvalvular gradient after the MitraClip (MC) (Abbott Laboratories, Abbott Park, Illinois) procedure ...on patient outcome during follow-up. Background Percutaneous transcatheter repair of the mitral valve with the MC device has been established as a novel technique for patients with severe mitral regurgitation and high surgical risk. This study investigated the influence of an increased pressure gradient after MC implantation on the long-term outcome of patients. Methods A total of 268 patients were enrolled, who received MC implantation between April 2009 and July 2014 in our institution (75 ± 9 years of age, 68% men, weight 76 ± 15 kg, median N-terminal pro–B-type natriuretic peptide 3,696 interquartile range: 1,989 to 7,711 pg/ml, left ventricular ejection fraction 39 ± 16%, log European System for Cardiac Operative Risk Evaluation score 20% interquartile range: 12% to 33%). Pressure in the left atrium and left ventricle were measured during the procedure using fluid-filled catheters. The pressure gradients over the mitral valve were determined simultaneously invasively and echocardiographically directly after MC deployment. A Kaplan-Meier analysis was performed and correlated with the pressure gradients. We used a combined primary endpoint: all-cause-mortality, left ventricular assist device, mitral valve replacement, and redo procedure. Results The Kaplan-Meier-analysis showed a significantly poorer long-term-outcome in the case of an invasively determined mitral valve pressure gradient (MVPG) in excess of 5 mm Hg at implantation for the combined endpoint (p = 0.001) and for all-cause mortality (p = 0.018). For the echocardiographically determined MVPG the cutoff value was 4.4 mm Hg. Propensity score matching was used to balance baseline differences between the groups. In a Cox model the increased residual MVPG >5 mm Hg was a significant outcome predictor in univariate and multivariate analysis (hazard ratio: 2.3; 95% confidence interval: 1.4 to 3.8; p = 0.002, multivariate after adjustment for N-terminal pro–B-type natriuretic peptide, age, and remaining mitral regurgitation). Conclusions It is recommended that the quality of the implantation result be analyzed carefully and repositioning of the MC be considered in the case of an elevated pressure gradient over the mitral valve.
At present, underfilling or overfilling the volume of the balloon-expandable transcatheter heart valve (THV) is generally utilized in transcatheter aortic valve implantation (TAVI). However, no ...research has assessed the clinical impact of filling volume variations of the current-generation SAPIEN 3 THV. We analyzed the clinical data of 331 patients who underwent TAVI with SAPIEN 3 at our institution. Post-procedural echocardiographic and multidetector computed tomography (MDCT) scan data and 3-year prognoses according to each filling volume were assessed. The procedural outcomes and 3-year mortality rates were comparable among the underfilling, nominal filling, and overfilling groups. For all THV sizes, the THV area evaluated on post-procedural MDCT scan increased stepwise along with an elevated filling volume, thereby covering a wide range of native annulus area. Compared with patients in the nominal filling and overfilling groups, those with 23-mm THVs in the underfilling group had a smaller effective orifice area (EOA) (1.38 IQR: 1.18–1.56 vs. 1.57 IQR: 1.41–1.84 vs. 1.58 IQR: 1.45–1.71 cm
2
,
P
= 0.02) and a higher mean transvalvular gradient (13.6 IQR: 11.0–15.7 vs. 12.1 IQR: 9.0–14.9 vs. 12.0 IQR: 8.1–14.8 cm
2
,
P
= 0.04). In conclusion, by adjusting the filling volume of SAPIEN 3 using THV with limited sizes, continuously distributed native annulus areas were covered. The underfilling implantation technique had a minimal negative effect on the valve function of 23-mm THVs only. In the entire cohort, the filling volume variations did not affect the mid-term prognosis negatively.
Background: Left atrial appendage closure (LAAC) usually requires contrast medium during the procedure. However, patients with chronic kidney disease (CKD) are at high risk of developing contrast ...nephropathy. This study aimed to assess the safety and feasibility of zero-contrast LAAC in patients with CKD.Methods and Results: Zero-contrast LAAC was attempted in 15 patients with CKD Stages 3b-5 who were not on hemodialysis. All procedures were performed successfully, without any periprocedural complications. At the 45-day follow-up, no device-related complications or acute kidney disease were observed.Conclusions: The strategy of zero-contrast LAAC in patients with CKD can be an acceptable option.
Mechanical compression of left ventricular outflow tract (LVOT) was reported to be a leading cause of conduction impairment requiring permanent pacemaker implantation (PPI) after transcatheter aortic ...valve replacement (TAVR). However, the association between tapered-shape LVOT and PPI after TAVR has not been elucidated. Of 272 consecutive patients treated with SAPIEN 3 in our institute, we retrospectively analyzed the clinical data of 256 patients without previous PPI or bicuspid valve. In-hospital PPI was performed in 20 (7.8%) patients at 8.2 ± 2.9 days after TAVR. Patients requiring PPI had smaller LVOT area (356.3 vs. 399.4 mm
2
,
p
≤ 0.011). Moreover, receiver operating characteristic statistics showed that LVOT area /annulus area possessed significantly higher predictive ability than LVOT area (c-statistic: 0.91 95% confidence interval CI: 0.84–0.95 vs. 0.67 95% CI: 0.57–0.77,
p
< 0.001). Multivariable analysis revealed that LVOT area /annulus area (odds ratio OR: 1.93 95% CI: 1.38–2.71;
p
< 0.001 per % of decreasing), the difference between membranous septum length and implantation depth (ΔMSID) (OR: 6.82 95% CI 2.39–19.48;
p
< 0.001 per mm of decreasing) and pre-existing complete right bundle branch block (CRBBB) (OR: 32.38 95% CI2.30–455.63;
p
≤ 0.002) were independently associated with PPI. In our study, tapered-shape LVOT as well as short ΔMSID and pre-existing CRBBB were identified as independent predictors for PPI after TAVR. Higher valve implantation is required to minimize the risk of post-procedural PPI especially for patients with short MS length, pre-procedural CRBBB, or tapered-shape LVOT.
•The STS score was designed to predict 30-day mortality after cardiac surgery.•Lower mortality after transcatheter aortic valve implantation than was predicted.•High STS score is associated with an ...increased risk of long-term mortality.•Similar long-term mortality in patients with low and intermediate scores.
The Society of Thoracic Surgeons (STS) risk model, designed to predict operative mortality after cardiac surgery, is often used for the risk assessment of patients considered for transcatheter aortic valve implantation (TAVI). We investigated the long-term prognostic value of the STS score by utilizing the data of 2588 patients undergoing TAVI from the OCEAN (Optimized CathEter vAlvular iNtervention)—TAVI Japanese multicenter registry. The patients were divided into 3 groups according to their pre-procedural STS score as follows: low-risk (STS score <4%, n = 467 18%), intermediate-risk (4%≤ STS score <8%, n = 1200 46.4%), and high-risk (8%≤ STS score, n = 921 35.6%). Low-risk patients were younger and were more frequently male. The prevalence of most of the comorbidities were higher in high-risk patients, while active cancer was more frequent in low-risk patients (p <0.001).The cumulative 4-year all-cause mortality rates were higher in high-risk patients (49.0%) but comparable in low-risk (22.6%) and intermediate-risk patients (28.7%) (hazard ratio HR for intermediate-risk versus low-risk, 1.03; 95% confidence interval CI, 0.77 to 1.37; p = 0.85; HR for high-risk versus low-risk, 2.27; 95% CI 1.72 to 2.99; p = <0.001). Similarly, the cumulative 4-year cardiovascular mortality rates were higher in high-risk patients (20.5%) but comparable in low-risk (9.9%) and intermediate-risk patients (10.3%) (HR for intermediate-risk versus low-risk, 1.10; 95% CI, 0.68 to 1.77; p = 0.69; HR for high-risk versus low-risk, 2.33; 95% CI 1.48 to 3.67; p = <0.001). After adjustment for several confounders, STS score ≥8% was independently associated with increased long-term mortality (HR, 1.35; 95% CI, 1.08 to 1.68). In conclusion, the risk stratification according to STS score demonstrated an increased risk of long-term mortality after TAVI in high-risk patients, albeit with comparable risks in intermediate- and low-risk patients.
Key Clinical Message
Three‐dimensional multiplanar analysis and real‐time three‐dimensional guidance using transesophageal echocardiography can help to identify and access the ideal position for ...transseptal puncture even in the presence of atrial septal occluders.
Transseptal puncture (TSP) for the percutaneous mitral valve edge‐to‐edge repair (PMVR) after percutaneous atrial septal defect (ASD) closure is a rare and challenging issue. Here, we present a case illustrating the feasibility of real‐time three‐dimensional transesophageal echocardiographic guidance for TSP without ASD closure device injury.
Three‐dimensional multiplanar analysis and real‐time three‐dimensional guidance using transesophageal echocardiography can help to identify and access the ideal position for transseptal puncture even in the presence of atrial septal occluders.
•The left atrial appendage closure (LAAC) has recently been introduced in Japan.•The real-world data on LAAC in Japanese patients are scarce.•The initial experience showed a high success rate but ...high post-procedural bleeding.•The optimal antithrombotic regimens considering each background are warranted.
The left atrial appendage closure (LAAC) device for patients with nonvalvular atrial fibrillation (NVAF) has recently been introduced in Japan. However, clinical data of Japanese patients are insufficient.
In this single-center study, 55 consecutive patients (mean age, 74 years) who received LAAC therapy from September 2019 to December 2020 were analyzed. The WATCHMAN implant procedure (Boston Scientific, St. Paul, MN, USA) was performed under transesophageal echocardiography and general anesthesia for all cases.
The baseline CHA2DS2-VASc score was 4.6 ± 1.4, and the baseline HAS-BLED score was 3.8 ± 0.9. All procedures (98.2%) were successful, except for one, and no procedure-related complications were observed. After the procedures, various antithrombotic regimens were employed according to the bleeding risk of each patient; warfarin was used in 27 patients (49%), direct oral anticoagulants (DOACs) were used in 22 patients (40%), and dual antiplatelet therapy (DAPT) was employed in 6 patients. During a mean follow-up of 360 days, three cases of device-related thrombus (DRT) were detected. One DRT case was related to ischemic stroke. Nine patients had major bleeding during follow-up: two patients received DOACs, six patients received DAPT, and one patient received aspirin.
In this initial Japanese experience, LAAC therapy for high bleeding risk patients with NVAF seems feasible. Optimal antithrombotic regimens are warranted for better clinical outcomes.
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