Initial results of transcatheter modification of left atrial appendage by obliteration with device in patients with nonvalvular atrial fibrillation: Real-world data from the TERMINATOR registry.

BACKGROUND: Percutaneous left atrial appendage closure (LAAC) has increased for those who need alternative to long-term anticoagulation with non-valvular atrial fibrillation (NVAF). METHODS AND RESULTS: From September 2019, after initiating WATCHMAN (Boston Scientific, Maple Grove, MN, USA) device implantation, we established Transcatheter Modification of Left Atrial Appendage by Obliteration with Device in Patients from the NVAF (TERMINATOR) registry. Utilizing 729 patients' data until January 2022, we analyzed percutaneous LAAC data regarding this real-world multicenter prospective registry. A total of 729 patients were enrolled. Average age was 74.9 years and 28.5 % were female. Paroxysmal AF was 37.9 % with average CHADS2 3.2, CHA2DS2-VASc 4.7, and HAS-BLED score of 3.4. WATCHMAN implantation was successful in 99.0 %. All-cause deaths were 3.2 %, and 1.2 % cardiovascular or unexplained deaths occurred during follow-up [median 222, interquartile range (IQR: 93-464) days]. Stroke occurred in 2.2 %, and the composite endpoint which included cardiovascular or unexplained death, stroke, and systemic embolism were counted as 3.4 % [median 221, (IQR: 93-464) days]. Major bleeding defined as BARC type 3 or 5 was seen in 3.7 %, and there was 8.6 % of all bleeding events in total [median 219, (IQR: 93-464) days]. CONCLUSIONS: These preliminary data demonstrated percutaneous LAAC with WATCHMAN device might have a potential to reduce stroke and bleeding events for patients with NVAF. Further investigation is mandatory to confirm the long-term results of this strategy using this transcatheter local therapy instead of life-long systemic anticoagulation.

Cystatin C in risk prediction after transcatheter aortic valve replacement: a retrospective analysis.

AIMS: No study has evaluated the prognostic value of the chronic kidney disease (CKD) classification by cystatin C-based estimated glomerular filtration rate (eGFR) (CKDCys classification) in patients undergoing transcatheter aortic valve replacement (TAVR). This study aimed to compare the prognostic value of CKDCys classification and CKD classification by creatinine-based eGFR (CKDCr classification) in risk prediction after TAVR. METHODS AND RESULTS: We retrospectively analysed consecutive 219 patients with symptomatic severe aortic stenosis who underwent TAVR at our institute between December 2016 and June 2019. Pre-operative CKDCr and CKDCys classifications were evaluated for their prognostic value of 2-year major adverse cardiovascular and cerebrovascular events (MACCE) after TAVR. MACCE was defined as the composite of all-cause mortality, non-fatal myocardial infarction, stroke, and rehospitalization for worsening congestive heart failure. Participants had a median age of 86.0 years and were predominantly female (76.9%). In 96.6% of the cases, TAVR was performed using transfemoral access. The median creatinine-based eGFR (52.85 mL/min/1.73 m2 ) was higher than the cystatin C-based eGFR (41.50 mL/min/1.73 m2 ). Downward reclassification in CKD stages based on eGFRCys was observed in 49.0% of patients. During a median follow-up period of 575.5 (interquartile range: 367.0-730.0) days, 58 patients presented with MACCE. CKDCys classification, but not CKDCr classification, significantly stratified the risk of 2-year MACCE in patients after TAVR by log-rank test (P = 0.003). In multivariate Cox regression analysis, only CKDCys stage 3b [hazard ratio (HR) = 4.37; 95% confidence interval (CI): 1.28-14.91; P = 0.019] and CKDCys stage 4 + 5 (HR = 3.72; 95% CI: 1.06-12.99; P = 0.040) were significant predictors of MACCE after adjustment for potential confounders. CONCLUSIONS: The CKDCys classification could better assess the risk than the CKDCr classification in patients undergoing TAVR. CKDCys stage 3b and stage 4 + 5 correlated with adverse outcomes.

Impact of New York Heart Association Functional Class on Outcomes After Transcatheter Aortic Valve Implantation.

BACKGROUND: In the current guidelines, indications for transcatheter aortic valve implantation (TAVI) are expanded to include several subgroups of asymptomatic patients with severe aortic stenosis (AS), and there is a paucity of data on the prognostic impact of New York Heart Association (NYHA) functional class in patients with severe AS undergoing TAVI. METHODS: Among 2588 patients enrolled in the OCEAN-TAVI registry, patients were divided into 4 groups according to baseline NYHA class (class I in 95 patients, class II in 1172 patients, class III in 1126 patients, and class IV in 195 patients). RESULTS: Median follow-up was 729 days. The cumulative 2-year incidence of all-cause death was significantly higher in patients with NYHA class IV and III than in those with NYHA class II and I. (30.0%, 21.3%, 13.4%, and 11.2%, respectively, P < 0.001). After adjusting confounders, NYHA class IV and III, but not NYHA class II were independently associated with higher mortality compared with NYHA class I (reference) (adjusted HR: 3.43, 95%CI: 1.83-7.15, P < 0.001; adjusted HR: 2.07, 95%CI: 1.15-4.19, P = 0.013; and adjusted HR: 1.50, 95%CI: 0.83-3.04, P = 0.19, respectively). With increasing NYHA class, there was an incremental increase of heart failure hospitalization in the effect size relative to the reference (NYHA class I). CONCLUSIONS: The long-term outcomes of patients with NYHA class I were better than those with NYHA class IV or III in some selected patients undergoing TAVI.

Recapture failure in transcatheter aortic valve replacement with CoreValve Evolut R.

Self-expanding prostheses for transcatheter aortic valve replacement (TAVR), which can be recaptured, provide us the option of repositioning for a more accurate placement. We report a very rare case in which the recapture of CoreValve Evolut R (Medtronic, Minneapolis, Minnesota) to correct the implantation depth during the deployment could not be achieved. We planned TAVR with a 23 mm Evolut R prosthesis for a 92-year-old female with severe aortic stenosis and tightly bent thoracic aorta. During the first deployment attempt, the implantation depth was greater than we expected at 2/3 deployment. They tried to recapture and reposition the prosthesis, but the prosthesis was not re-sheathed into the capsule of the delivery system. The prosthesis could not be recaptured despite a repeat attempt, and they were forced to deploy the device as it was. The prosthesis was deployed very carefully and implanted successfully without a pop-up into the ascending aorta. At a later date, this situation was replicated in vitro and was found that the distal segment of the capsule became deformed, increasing the resistance to rotating the grip handle.

Prognostic value of cardiac 123 I-metaiodobenzylguanidine imaging for predicting cardiac events after transcatheter aortic valve replacement.

AIMS: In patients with aortic valve stenosis (AS), cardiac sympathetic nervous (CSN) dysfunction and its improvement after transcatheter aortic valve replacement (TAVR) have been reported. The prognostic impact of CSN function remains unclear. This study investigated the prognostic value of cardiac 123 I-metaiodobenzylguanidine (MIBG) imaging for predicting cardiac events after TAVR. METHODS AND RESULTS: This single-centre prospective observational study enrolled patients with AS between July 2017 and May 2019. MIBG scintigraphy was performed before and soon after TAVR to evaluate the late heart-mediastinum ratio (L-H/M). Patients were classified into three pairs of groups based on the baseline and post-TAVR L-H/M (≥2.0 or <2.0) and on the presence of TAVR-related improvement in L-H/M. The study endpoint was the occurrence of major adverse cardiac events (MACE), defined as a composite of all-cause death, non-fatal myocardial infarction, and hospitalization due to heart failure. Among the 187 consecutive patients who underwent TAVR, 107 (27 men; median age: 86 years) were evaluated. Over a median follow-up of 366 days, 15 (14.0%) patients had MACE. The incidence of MACE was significantly low in patients with L-H/M improvement and/or high post-TAVR L-H/M (≥2.0). Baseline L-H/M and frailty were associated with poor response of L-H/M to TAVR treatment. TAVR-related improvement in L-H/M had significant effects on MACE, with an adjusted hazard ratio of 0.233 (95% confidence interval, 0.064-0.856; P = 0.028). CONCLUSIONS: TAVR-related improvement in L-H/M was an independent predictor of cardiac events, 1 year after TAVR. Cardiac MIBG imaging is useful for predicting cardiac events after TAVR.

Comparative Analysis of the Paclitaxel-Eluting Peripheral Igaki-Tamai Stent and the Drug-Free Igaki-Tamai Stent Using Optical Coherence Tomography and Histological Analysis in a Porcine Iliac Artery Model.

BACKGROUND: The combination of a bioresorbable scaffold and antiproliferative drugs is a promising treatment for peripheral artery disease. The novel paclitaxel-eluting peripheral Igaki-Tamai stent (PTX-ITS) has the same backbone design as the drug-free peripheral Igaki-Tamai stent and a paclitaxel coating. Arterial responses to the PTX-ITS and ITS using optical coherence tomography (OCT) and histological analysis in a porcine iliac artery model were compared.Methods and Results:In total, 6 PTX-ITSs and 6 ITSs implanted in porcine iliac arteries were evaluated. Quantitative measurements of the scaffold, lumen, neointimal areas, and percent area stenosis were performed using OCT at 1 and 3 months. Histological evaluations (PTX-ITS [n=5], ITS [n=4]) were performed following euthanasia at 3 months. Injury, inflammation, endothelialization, and fibrin scores were measured. Baseline angiographic characteristics were similar in both groups. The ITS group showed significantly smaller scaffold areas than the PTX-ITS group at 1 month (18.50±3.62 mm2vs. 23.54±3.64 mm2; P=0.037) and 3 months (15.82±2.57 mm2vs. 21.67±3.57 mm2; P=0.009). Percent area stenosis was significantly lower in the PTX-ITS group at 3 months (28.70±7.24% vs. 40.36±7.07%; P=0.018). Histological evaluations revealed similar low-grade inflammatory reactions for both scaffolds. CONCLUSIONS: PTX-ITSs showed significantly better suppression of late scaffold shrinkage and lower in-scaffold stenosis for up to 3 months. Additionally, PTX-ITSs exhibited high biocompatibility, which is comparable to ITSs.

Importance of Preoperative Computed Tomography Assessment of the Membranous Septal Anatomy in Patients Undergoing Transcatheter Aortic Valve Replacement With a Balloon-Expandable Valve.

BACKGROUND: Cardiac conduction disturbance (CD) is the most frequent complication following transcatheter aortic valve replacement (TAVR). This study examined whether the anatomy of the membranous septum (MS) could provide useful information about the risk of CD following TAVR with a balloon-expandable valve (BEV).Methods and Results:Among 132 consecutive patients, 106 (mean age, 85.6±5.1 years; 75 females) were included in the study. Using preoperative CT and angiography, MS length and implantation depth (ID) were assessed. The MS length minus the prosthesis ID was calculated (∆MSID). Correlation between CD, defined as new-onset left-bundle branch block (LBBB) or the need for permanent pacemaker (PPM) within 1 week after the procedure, and MS length were evaluated. A total of 19 patients (18%) developed CD following TAVR. MS length was significantly shorter in these patients than in those without CD (5.3±1.3 vs. 6.6±1.4; P<0.001), and was the important predictor of CD (odds ratio [OR]: 0.43, 95% confidence interval [CI]: 0.27-0.69, P<0.001). When considering the pre- and postprocedural parameters, the ∆MSID was smaller in patients with CD (-1.7±1.5 vs. 0.8±1.9, P<0.001), and emerged as the important predictor of CD (OR: 0.47, 95% CI: 0.33-0.69, P<0.001). CONCLUSIONS: Short MS is associated with an increased risk of CD after TAVR with BEV.

Early effects of transcatheter aortic valve replacement on cardiac sympathetic nervous function assessed by 123I-metaiodobenzylguanidine scintigraphy in patients with severe aortic valve stenosis.

PURPOSE: The effects of transcatheter aortic valve replacement (TAVR) on cardiac sympathetic nervous (CSN) function have not been fully explored. This study aimed to investigate the early (within 2 weeks) effects of TAVR on CSN function in patients with severe aortic valve stenosis (AS) using 123I-metaiodobenzylguanidine (MIBG) scintigraphy. METHODS: Of 143 consecutive patients who were scheduled to undergo TAVR, 67 (18 men; median age 86 years) were evaluated in this single-centre prospective observational study. MIBG scintigraphy was performed at baseline and 3-14 days after the TAVR procedure to evaluate the heart-mediastinum ratio (H/M) and washout rate (WR). Differences between baseline and post-TAVR MIBG parameters were analysed. MIBG parameter changes were compared with echocardiographic parameters. Furthermore, factors involved in the improvement in MIBG parameters were investigated. RESULTS: All patients successfully underwent TAVR with improved echocardiographic parameters, including aortic valve area (AVA; 0.6 cm2 vs. 1.6 cm2), peak velocity (4.5 m/s vs. 2.0 m/s), mean pressure gradient (50 mmHg vs. 9 mmHg), and left ventricular ejection fraction (56% vs. 62%) (all p < 0.001). On MIBG imaging, delayed H/M significantly increased (2.57 vs. 2.68, p < 0.001), whereas WR decreased (32.2% vs. 26.8%, p < 0.001). In multivariate analysis, higher baseline WR was associated with improvement in WR (> 3%). Female sex, Clinical Frailty Scale score ≤ 5, baseline estimated glomerular filtration rate, and baseline AVA were predictors of improvement in delayed H/M (> 0.1). Baseline AVA and E/E' were independent predictors of improvement in both WR and delayed H/M. CONCLUSIONS: The CSN function was impaired in patients with AS, as assessed using MIBG scintigraphy. WR and delayed H/M improved immediately after TAVR. Improvement in CSN function may be related to echocardiographic AS severity at baseline before TAVR.

A newly designed 0.018-in.-compatible inner dilator as a novel option for endovascular therapy with the crossover approach.

This study aimed to investigate the efficacy of guiding sheath delivery with the crossover approach using a newly customized inner dilator for a 0.018-in. guidewire of the Destination® guiding sheath (Terumo Corporation, Tokyo, Japan) (18-system), compared with that of the conventional-type 0.035-in. guidewires with inner dilators (35-system), and to predict failure of guiding sheath delivery. We conducted a prospective multicenter case series study of the contralateral crossover approach using Destination®, to determine whether the 18-system could be a rescue system in cases in which the conventional 35-system failed. To evaluate the efficacy of the 18-system, we created an in vitro aortoiliac bifurcation model by using a silicone vessel. We enrolled 172 cases consecutively. The initial crossover approach with the 35-system failed in 37 cases (21.5%), and a second attempt with the 18-system was successful in all failed cases. The bifurcation angles in the 35-system failure cases were significantly steeper than those in the 35-system success cases. A receiver operating characteristic curve analysis demonstrated that an aortoiliac bifurcation angle of 68° was the optimal cut-off value for predicting failure of the crossover procedure. Data from the analysis using the silicone vessel model suggested that the 18-system provided superior results, especially in aortoiliac bifurcation angles steeper than 60°, consistent with the in vivo findings. The results of the initial use of the 18-system with the crossover approach suggest that it may be superior to the conventional 35-system, especially in cases of steeper aortoiliac bifurcation angles.

A case of arrhythmogenic right ventricular cardiomyopathy presenting with progressive right ventricular failure and recurrent multifocal monomorphic ventricular tachycardia during 15 years of follow-up.

Arrhythmogenic right ventricular cardiomyopathy (ARVC) is a multigenic form of cardiomyopathy characterized by myocardial loss and fibrofatty replacement mainly in the right ventricle. Progressive right ventricular dysfunction, ventricular arrhythmias, and sudden cardiac death are the clinical picture of this disease. Despite its clinical importance as a cause of sudden death, ARVC is likely to be under-recognized. In case reports about ARVC, disease characteristics such as arrhythmias, images, and genes are described in fragments. Little is reported about the long-term course of ARVC in the same patient. In this report, we present a case of a 68-year-old male who was diagnosed with ARVC after his first episode of ventricular tachycardia. Both mechanical and electrical progression were seen during the 15 years of follow-up, requiring the modification of disease management. This report could help improve the understanding of this rare disease, and the way of its management. .