Cusp overlap method for self-expanding transcatheter aortic valve replacement.

BACKGROUND: Conduction disturbances and the need for permanent pacemaker (PPM) implantation remains a common complication for transcatheter aortic valve replacement (TAVR), particularly when self-expanding (SE) valves are used. AIMS: We compared in-hospital and 30-day rates of new PPM implantation between patients undergoing TAVR with SE valves using the conventional three-cusp coplanar implantation technique and the cusp-overlap technique. METHODS: We retrospectively compared patients without a pre-existing PPM who underwent a TAVR procedure with SE Evolut R or PRO valves using the cusp-overlap technique from July 2018 to September 2020 (n = 519) to patients who underwent TAVR using standard three-cusp technique from April 2016 to March 2017 (n = 128) in two high volume Canadian centers. RESULTS: There was no significant difference in baseline RBBB between the groups (10.4% vs. 13.2; p = 0.35). The rate of in-hospital new complete heart block (9.4% vs. 23.4%; p ≤ 0.001) and PPM implantation (8% vs. 21%; p ≤ 0.001) were significantly reduced when using the cusp-overlap technique. The incidence of new LBBB (30.4% vs. 29%; p = 0.73) was similar. At 30 days, the rates of new complete heart block (11% vs. 23%; p ≤ 0.001) and PPM implantation (10% vs. 21%, p ≤ 0.001) remained significantly lower in the cusp-overlap group, while the rate of new LBBB (35% vs. 30%; p = 0.73) was similar. CONCLUSION: Cusp-overlap approach offers several potential technical advantages compared to standard three-cusp view, and may result in lower PPM rates in TAVR with SE Evolut valve.

Long-Term Assessment of Survival After Transcatheter Aortic Valve Implantation　- Insights From the International Transcatheter Aortic Valve Implantation Registry.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) is an established treatment for severe aortic stenosis (AS), but despite estimates of life expectancy after TAVI being essential in heart team discussion, these data are scarce. Therefore, the current study sought to assess long-term survival and its trends in relation to chronological age, surgical risk, and treatment period.Methods and Results: We included 2,414 consecutive patients who underwent TAVI for severe symptomatic AS between 2008 and 2021 at 2 international centers. For the analysis, long-term survival was evaluated according to age, surgical risk, and treatment period categorized into 3 groups, respectively. The longest follow-up was 13.5 years. Overall survival was 67.6% at 5 years and 26.9% at 10 years. Younger patients, lower surgical risk, and later treatment period showed better survival (log-rank P<0.001, respectively). In the multivariate analysis, age <75years, lower surgical risk, and later time period were significantly associated with better survival. The incidence of paravalvular leakage ≥moderate, red blood cell transfusion, and acute kidney injury were independently associated with increasing risk of 5-year death. CONCLUSIONS: In a real-world registry, survival was substantial following TAVI, especially in younger and lower surgical-risk patients, with improving outcomes over time. This should be considered in heart team discussions of life-long management for AS patients after TAVI.

Infective endocarditis after transcatheter edge-to-edge repair for severe mitral regurgitation; a case report and a systematic review.

Transcatheter edge-to-edge repair (TEER) is used extensively in patients with symptomatic severe mitral regurgitation and high surgical risk. While prosthetic valve endocarditis is well documented, infective endocarditis (IE) after TEER is a rare occurrence. To date, no study has been conducted on this complication. We report the case of an 85-year-old man who developed IE 3 months after undergoing TEER, and we systematically review 26 previously published cases of this complication. Our review findings indicate that discussion within the heart team is essential for the decision-making process and treatment strategy determination.

Effect of Sex on Mortality and Left Ventricular Remodeling After Transcatheter Aortic Valve Implantation.

BACKGROUND: The effect of sex on mortality is controversial; furthermore, sex differences in left ventricular (LV) remodeling after transcatheter aortic valve implantation (TAVI) remain unknown.Methods and Results:This study included 2,588 patients (1,793 [69.3%] female) enrolled in the Optimized CathEter vAlvular iNtervention (OCEAN)-TAVI Japanese multicenter registry between October 2013 and May 2017. We retrospectively analyzed the effect of sex on mortality, and evaluated changes in the LV mass index (LVMI) after TAVI. Female sex was significantly associated with lower all-cause and cardiovascular mortality (log-rank P<0.001 for both). Multivariate analysis showed that female sex was independently associated with lower cumulative long-term mortality (hazard ratio 0.615; 95% confidence interval 0.512-0.738; P<0.001). Regression in the LVMI was observed in both sexes, and there was no significant difference in the percentage LVMI regression from baseline to 1 year after TAVI between women and men. Women had a survival advantage compared with men among patients with LVMI regression at 1 year, but not among patients with no LVMI regression. CONCLUSIONS: We found that female sex is associated with better survival outcomes after TAVI in a large Japanese registry. Although LVMI regression was observed in women and men after TAVI, post-procedural LV mass regression may be related to the sex differences in mortality.

Comparison between cryoballoon ablation and radiofrequency catheter ablation for atrial fibrillation in patients on hemodialysis.

BACKGROUND: Difficulties are often encountered while controlling atrial fibrillation (AF), especially in hemodialysis (HD) patients. Previous data revealed that cryoballoon ablation (CBA) for treating paroxysmal atrial fibrillation (PAF) was not inferior to radiofrequency ablation (RFA); however, HD patients were excluded in this prior trial. Thus, the efficacy of CBA for HD patients is still unknown. METHODS: This retrospective study analyzed HD patients who underwent catheter ablation (CA) for AF from August 2011 to June 2019. Patients who received CBA (CBA group) and those who received RFA (RFA group) were compared. The primary endpoint was defined as freedom from a composite outcome (a documented recurrence of any atrial tachyarrhythmia or a prescription of antiarrhythmic drugs) at one year after CA. RESULTS: The RFA and CBA groups were composed of 21 and 23 patients, respectively. Freedom from a composite outcome was 58.4% in the RFA group and 68.2% in the CBA group (Log-rank: p = 0.571). CONCLUSION: Our results suggest that patients on HD with AF who were treated with CBA tended to have better outcomes than patients treated with RFA. Therefore, CBA could be a suitable ablation method for HD patients.

The efficacy of modified jailed balloon technique for true bifurcation lesions.

OBJECTIVE: To evaluate the short-, long-term clinical and angiographic outcomes after treatment of true bifurcation lesions using a modified jailed balloon technique (MJBT). BACKGROUND: Percutaneous coronary intervention (PCI) for true bifurcation lesions has high risk for adverse events. Side branch (SB) occlusion is one of the most serious complications. Therefore, novel strategies to avoid SB occlusion during main branch stenting and to keep its patency are important. METHODS AND RESULTS: Between February 2015 and February 2018, 328 patients with 349 true bifurcation lesions underwent PCI using MJBT. True bifurcation lesions were defined as Medina classifications (1.1.1), (1.0.1) or (0.1.1) lesions. We investigated the procedural and long-term clinical outcomes. Furthermore, angiographic outcomes were assessed at follow-up diagnostic angiography. The mean age of patients was 71.6 ± 9.9 years. Procedural success was achieved in all patients; postoperative SB occlusion was noted in only one patient (0.3%). The cumulative incidence of all-cause death was 23 patients (7.0%) in the follow-up period (median 717 days). Target lesion revascularization was performed in 19 patients (5.8%) with 23 lesions (6.6%), and 0.6% of myocardial infarction and 0% of definite stent thrombosis were observed. Angiographic follow-up was performed in 243 patients (74.1%); the percent diameter stenosis in SB was not significantly different between after the index procedure and follow-up angiography. CONCLUSIONS: This MJBT is safe and effective in preserving SB patency for true bifurcation lesions. Furthermore, long-term clinical and angiographic outcomes after MJBT are feasible.

New-Generation Transcatheter Aortic Valves in Patients With Small Aortic Annuli　- Comparison of Balloon- and Self-Expandable Valves in Asian Patients.

BACKGROUND: Asian patients have smaller aortic annuli. Although 20-mm balloon-expandable (BE) transcatheter heart valves (THV) are manufactured for transcatheter aortic valve implantation (TAVI) in these cases, the supra-annular design of self-expandable (SE) THV is considered more suitable; however, real-world comparative data are scarce.Methods and Results:Consecutive TAVI cases (n=330) in a single Japanese center were reviewed. Based on the cutoff for the new-generation 20-/23-mm BE-THV, a small aortic annulus was defined as <330 mm2. A considerable number of patients had small annuli: 49/302 (16%). Of these, 33 BE-THV and 13 SE-THV using new-generation valves were compared. Although the SE-THV group had smaller annulus area (median 297 (interquartile range, 280-313) vs. 309 (303-323) mm2(P=0.022)), it had more favorable post-procedural parameters; for SE-THV and BE-THV, respectively, effective orifice area (EOA), 1.5 (1.3-1.6) vs. 1.1 cm2(0.9-1.3) (P=0.002); mean pressure gradient, 7.6 (5.6-11.0) vs. 14.2 mmHg (11.2-18.8) (P=0.001); and peak velocity, 1.8 (1.6-2.4) vs. 2.7 m/s (2.3-3.1) (P=0.001). Although new left bundle branch block was higher with SE-THV (24% and 62%, P=0.02), patient-prosthesis mismatch (PPM) ≥ moderate (indexed EOA <0.85 cm2/m2) was significantly less with SE-THV than with BE-THV (8% vs. 55%; P=0.04). Hemodynamic findings were consistent up to 1 year. CONCLUSIONS: Small annuli are often seen in Asian patients, for whom SE-THV implantation results in favorable hemodynamics with less PPM.

Impact of bleeding events after percutaneous coronary intervention in patients on hemodialysis.

Coronary artery disease is common in patients on dialysis; there is a high rate of bleeding events after percutaneous coronary intervention (PCI) in such patients. We investigated the impact of bleeding events after PCI on mortality in patients on hemodialysis. We included 386 consecutive hemodialysis patients who underwent PCI using a drug-eluting stent (DES) between September 2004 and December 2017 in our hospital, and investigated the impact of bleeding events on all-cause mortality after PCI. Bleeding events were assessed by the Thrombolysis in Myocardial Infarction (TIMI) bleeding definition within 24 months after PCI. A total of 42 patients experienced bleeding events. Of these, 30 patients (71.4%) had TIMI major bleeding events and 12 patients (28.6%) had TIMI minor bleeding events. Patients with bleeding events had significantly higher mortality than patients without bleeding events (survival rate, 55.1% vs 81.5%, log-rank: p < 0.001). These results suggest that bleeding events after PCI with a DES are notably associated with all-cause mortality among patients on hemodialysis. This is the first report about relationship between bleeding events and mortality to focus on patients on hemodialysis.

Impact of Late Ventricular Arrhythmias on Cardiac Mortality in Patients with Acute Myocardial Infarction.

OBJECTIVES: This study investigated the relationship between the timing of ventricular tachycardia or ventricular fibrillation (VT or VF) and prognosis in patients undergoing primary percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI). BACKGROUND: It is unknown whether the timing of VT/VF occurrence affects the prognosis of patients with AMI. METHODS: From January 2004 to December 2014, 1004 patients with AMI underwent primary PCI. Of these patients, 888 did not have VT/VF (non-VT/VF group) and 116 had sustained VT/VF during prehospitalization or hospitalization. Patients with VT/VF were divided into two groups: early VT/VF (VT/VF occurrence before and within 2 days of admission, 92 patients) and late VT/VF (VT/VF occurrence >2 days after admission; 24 patients) groups. RESULTS: The frequency of VT/VF occurrence was high between the day of admission and the 2nd day and between days 6 and 10 of hospitalization. The late VT/VF group had a significantly longer onset-to-balloon time, lower ejection fraction, poorer renal function, and higher creatine phosphokinase (CK)-MB level on admission (p< 0.001). They also had a lower 30-day cardiac survival rate than the early VT/VF and non-VT/VF groups (42% vs. 76% vs. 96%, p < 0.001). Moreover, independent predictors of in-hospital cardiac mortality among patients with AMI who had sustained VT/VF were higher peak CK-MB [Odds ratio (OR: 1.001, 95%confidence interval (CI): 1.000-1.002, p= 0.03)], higher Killip class (OR: 1.484, 95%CI 1.017-2.165, p= 0.04), and late VT/VF (OR: 3.436, 95%CI 1.115-10.59, p= 0.03). CONCLUSIONS: The timing of VT/VF occurrences had a bimodal peak. Although late VT/VF occurrence after primary PCI was less frequent than early VT/VF occurrence, patients with late VT/VF had a very poor prognosis.

Clinical Outcomes of Transcatheter Aortic Valve Implantation in Patients With Extremely Large Annulus and SAPIEN 3 Dimensions Based on Post-Procedural Computed Tomography.

BACKGROUND: Patients with severe aortic stenosis (AS) and an extra-large annulus (ELA) area (>683 mm2) can rarely be treated by transcatheter aortic valve replacement (TAVR) because of the size limitation of the transcatheter heart valves. This study aimed to evaluate the feasibility of TAVR using a 29-mm SAPIEN3 (S3) valve in patients with ELA and S3-dimensions by post-procedural computed tomography (post-CT). Methods and Results: We included 261 patients undergoing TAVR using a 29-mm S3: 30 patients with ELA and 231 with non-ELA were identified. S3-dimensions were evaluated at the S3 inflow and annulus level by post-CT in 129 patients. The ELA group had a greater aortic annulus area measured by pre-procedural CT (737.3±54.7 vs. 578.4±41.9 mm2, P<0.0001), higher balloon inflation volume (36 vs. 33 mL, P<0.0001), a larger S3 area at inflow by post-CT (729.6±42.2 vs. 682.2±35.0 mm2, P<0.001), and a correlation between the inflation volume and S3 area (r=0.71, P=0.0005). No differences were observed between groups in paravalvular aortic regurgitation (PAR) ≥mild (43.3% vs. 27.6%, P=0.09), PAR ≥moderate (3.3% vs. 1.3%, P=0.39) or 1-year mortality (10.0% vs. 9.1%, P=0.87). CONCLUSIONS: TAVR using a 29-mm S3 with extra inflation of the delivery balloon can be considered as a treatment option for patients with severe AS and ELA.

Hemodynamic comparison of CoreValve and SAPIEN-XT TAVI valves in Japanese patients.

Transcatheter aortic valve implantation (TAVI) is a viable treatment option for high-risk patients with severe aortic stenosis. In Japan, TAVI can be performed using first-generation self-expandable Medtronic CoreValve or balloon-expandable Edwards SAPIEN-XT from 2012. Since the durability and hemodynamic outcomes after transcatheter heart valve (THV) implantation in Japanese patients have not been clearly elucidated, we assessed serial changes in post-TAVI THV performances over a-3-year period by transthoracic echocardiography (TTE). From January 2012 to September 2014, among 83 patients with severe aortic stenosis, 26 underwent TAVI with CoreValve and 57 underwent TAVI with SAPIEN-XT. We assessed the serial changes in first post-implant (FPI) and 3-year post procedure THV hemodynamics by TTE. Valve performance was evaluated by serial assessment of aortic valve mean pressure gradient (PG) and aortic valve area (AVA) assessments. Three-year clinical outcomes were compared between the patients with CoreValve and those with SAPIEN-XT. Seventeen patients with CoreValve and 34 patients with SAPIEN-XT had FPI and 3-year TTEs. The AVA decreased significantly from FPI to 3-year follow-up among patients with SAPIEN-XT, but not among patients with CoreValve. The mean aortic PG decreased significantly from FPI to the 3-year follow-up point among patients with CoreValve; however, it was not significantly different from those with SAPIEN-XT. The absolute change in mean PG from FPI to the 3-year follow-up point decreased significantly among those with CoreValve compared to those with SAPIEN-XT. Clinical outcomes after TAVI were similar for both devices at 3-years after TAVI. In this study, long-term clinical outcomes for CoreValve and SAPIEN XT were similar. The 3-year THV performance of both devices was maintained after TAVI. Serial change in mean aortic PGs for CoreValve decreases significantly from FPI to the 3-year follow-up point compared to that for SAPIEN-XT.

Modified jailed balloon technique for bifurcation lesions.

OBJECTIVES: We propose a new systematic approach in bifurcation lesions, modified jailed balloon technique (M-JBT), and report the first clinical experience. BACKGROUND: Side branch occlusion brings with a serious complication and occurs in more than 7.0% of cases during bifurcation stenting. METHODS: A jailed balloon (JB) is introduced into the side branch (SB), while a stent is placed in the main branch (MB) as crossing SB. The size of the JB is half of the MB stent size. While the proximal end of JB attaching to MB stent, both stent and JB are simultaneously inflated with same pressure. JB is removed and then guidewires are recrossed. Kissing balloon dilatation (KBD) and/or T and protrusion (TAP) stenting are applied as needed. RESULTS: Between February 2015 and February 2016, 233 patients (254 bifurcation lesions including 54 left main trunk disease) underwent percutaneous coronary intervention (PCI) using this technique. Procedure success was achieved in all cases. KBD was performed for 183 lesions and TAP stenting was employed for 31 lesions. Occlusion of SV was not observed in any of the patients. Bench test confirmed less deformity of MB stent in M-JBT compared with conventional-JBT. CONCLUSIONS: This is the first report for clinical experiences by using modified jailed balloon technique. This novel M-JBT is safe and effective in the preservation of SB patency during bifurcation stenting.

Outcomes of Self-Expanding vs. Balloon-Expandable Transcatheter Heart Valves for the Treatment of Degenerated Aortic Surgical Bioprostheses　- A Propensity Score-Matched Comparison.

BACKGROUND: Transcatheter aortic valve-in-valve (VIV) replacement within failed bioprosthetic surgical aortic valves is a feasible therapeutic option. However, data comparing the hemodynamic and clinical outcomes of VIV replacement with supra-annular self-expanding and balloon-expandable transcatheter heart valves (THV) are limited. Methods and Results: Outcomes of 40 and 95 patients treated with supra-annular self-expanding and balloon-expandable THV, respectively, were compared after propensity score matching, which yielded 37 pairs of patients with similar baseline characteristics. Hemodynamic and clinical outcomes were analyzed. Postprocedural mean gradient was significantly lower in the self-expanding THV group than in the balloon-expandable THV group (12.1±6.1 mmHg vs. 19.0±7.3 mmHg, P<0.001). The incidence of at least mild postprocedural aortic regurgitation (AR) was comparable between the self-expanding and balloon-expandable THV groups (21.6% vs. 10.8%, P=0.39). In the self-expanding THV group, the new-generation THV showed a trend towards a lower incidence of at least mild AR compared with the early-generation THV (12.5% vs. 38.5%, P=0.07). A similar trend was observed in the balloon-expandable THV group (4.2% vs. 23.1%, P=0.08). There was no significant difference between the self-expanding and balloon-expandable THV groups in the cumulative 2-year all-cause mortality rates (22.4% vs. 43.4%, log-rank P=0.26). CONCLUSIONS: The supra-annular self-expanding THV was associated with a lower postprocedural mean gradient compared with balloon-expandable THV in patients undergoing aortic VIV replacement.

Initial and Long-Term Results of a Microcatheter-Based Retrograde Approach for the Endovascular Treatment of Chronic Total Occlusion in Iliac or Femoropopliteal Arteries.

BACKGROUND: Initial and long-term outcomes of the retrograde endovascular approach using a microcatheter for the treatment of chronic total occlusion (CTO) in the iliac or femoropopliteal (FP) arteries have not been fully elucidated. METHODS: From 2012 to 2014, 20 consecutive patients (21 limbs) underwent endovascular therapy (EVT) for CTO in the iliac or FP arteries using the microcatheter-based retrograde approach. An analysis of the initial and long-term outcomes was conducted. RESULTS: All procedures were successful. The mean follow-up duration was 27.4 ± 11.3 months. The mean patient age was 75.8 ± 9.1 years. Eighteen (85.7%) target lesions were located in the superficial femoral artery, 1 (4.8%) in the popliteal artery, and 2 (9.5%) in the iliac artery. All lesions were de novo. The mean occlusion length was 183.3 ± 95.4 mm. A stent was used in 19 (94.5%) lesions and balloon angioplasty was performed for 2 (5.5%) lesions. Retrograde puncture site complication (hematoma in popliteal artery) was reported in 1 (4.8%) patient. Postprocedure primary patency rates at 1, 2, and 3 years were 89.5%, 72.0%, and 41.2%, respectively, and the secondary patency rates at the corresponding time points were 100%, 77.2%, and 48.6%, respectively. CONCLUSIONS: Initial and long-term outcomes of EVT for CTO in iliac and FP arteries using the microcatheter-based retrograde approach are promising.

Prehospital Transfer Pathway and Mortality in Patients Undergoing Primary Percutaneous Coronary Intervention.

BACKGROUND: It is recommended that not only door-to-balloon time but also prehospital delay for primary percutaneous coronary intervention (PCI) should be improved. We investigated the effect of prehospital transfer pathway on onset-to-balloon time and prognosis in patients with ST-segment elevation myocardial infarction (STEMI) in Japan. METHODS AND RESULTS: We analyzed data from 540 consecutive patients with primary PCI for STEMI. Patient clinical data and mortality were compared between patients who visited the family physician or non-PCI-capable hospitals and were then transferred to PCI-capable centers (indirect transfer patients), and those who directly visited PCI-capable centers (direct transfer patients). Onset-to-balloon time was longer in indirect transfer patients than in direct transfer patients (mean, 270 min; range, 180-480 min vs. 180 min, 120-240 min; P<0.001). In addition, patient prognosis was evaluated on Cox proportional regression analysis. Cardiac death and all-cause death were significantly higher in indirect transfer patients (odds ratios [OR], 2.17; 95% confidence intervals [95% CI]: 1.17-4.01, P=0.01; OR, 1.71; 95% CI: 1.09-2.68, P=0.02). These results were confirmed using propensity score matching for adjusted analyses. CONCLUSIONS: Patients with indirect transfer to regional emergency departments of PCI centers had longer onset-to-balloon time and worse prognosis than those with direct transfer.

Haemodynamic and clinical outcomes at 5 years according to predicted prosthesis-patient mismatch after transcatheter aortic valve replacement.

BACKGROUND/PURPOSE: Although the impact of predicted prosthesis-patient mismatch (PPMP) on outcomes after surgical aortic valve replacement is well established, studies on PPMP in transcatheter aortic valve replacement (TAVR) are limited. This study investigated the effects of PPMp on haemodynamic and 5-year clinical outcomes after TAVR. METHODS/MATERIALS: We analysed 1733 patients who underwent TAVR. PPMp was defined using two different methods: 1) normal reference values of the effective orifice area for each valve type and size indexed to body surface area (PPMp1; n = 1733) and 2) reference values for aortic annulus area or perimeter assessed with pre-procedural computed tomography indexed to body surface area (PPMp2; n = 1227). The primary endpoint was the composite of all-cause death and/or rehospitalisation for heart failure at 5 years. RESULTS: The incidence of PPMp1 was 11.7 % and 0.8 % in moderate and severe cases, respectively. PPMp2 was classified as either moderate (3.8 %) or severe (0 %). Rates of residual mean aortic gradient ≥20 mmHg significantly increased depending on PPMp1 severity (no PPMp1: 3.1 % vs. moderate PPMp1: 26.8 % vs. severe PPMp1: 53.9 %, p < 0.0001) and PPMp2 (no PPMp2: 4.1 % vs. moderate PPMp2: 12.8 %, p = 0.0049). Neither of PPMP methods were associated with the composite outcome in total cohort; however, PPMP1 was significantly related to worse clinical outcomes at 5 years among patients with reduced left ventricular ejection fraction (LVEF) in multivariate analysis (HR: 1.87; 95 % CI: 1.02-3.43). CONCLUSIONS: The impact of PPMP on TAVR clinical outcomes may not be negligible in patients with low LVEF.

Risk Assessment of Permanent Pacemaker Implantation After Transcatheter Aortic Valve Implantation in Patients With Preexisting Right Bundle Branch Block.

Preexisting right bundle branch block (RBBB) is the strongest predictor for permanent pacemaker implantation (PPI) after transcatheter aortic valve implantation (TAVI). However, the risk assessment for new PPI and effective procedural strategy for preventing new PPI in patients with preexisting RBBB are still unclear. This study stratified the new PPI risk after TAVI and investigated the impact of implantation strategy in a preexisting RBBB cohort. We analyzed 237 patients with preexisting RBBB who underwent TAVI. The primary endpoint was the incidence of new PPI. Multivariate analyses investigating predictors for new PPI were performed. The overall PPI rate was 33.3%. Significant baseline predictors for new PPI were combination of RBBB, left anterior or posterior fascicular block, and first-degree atrioventricular block (odds ratio [OR] 2.55, 95% confidence interval [CI] 1.09 to 5.04), high calcium volume of noncoronary cusp (OR 2.08, 95% CI 1.05 to 4.10), and membranous septum (MS) length <2 mm (OR 2.02, 95% CI 1.09 to 3.75) in the univariate analysis and MS length <2 mm (OR 2.25, 95% CI 1.06 to 4.82) in the multivariate analysis. On the multivariate analysis including procedural variables, predilatation (OR 2.41, 95% CI 1.01 to 5.83), self-expanding valves (Corevalve, Evolut R, and Evolut Pro/Pro+; Medtronic Inc., Minneapolis, Minnesota) or mechanical expanding valves (Lotus/Lotus Edge; Boston Scientifics, Marlborough, Massachusetts) (OR 3.00, 95% CI 1.31 to 6.91), and implantation depth > MS length (OR 4.27, 95% CI 1.81 to 10.08) were significantly associated with new PPI. The incidence of new PPI increased according to the number of baseline predictors (0: 20.9%, 1: 34.3%, and ≥2: 52.0%) and procedural predictors (0: 3.7%, 1: 20.9%, 2: 40.5%, and 3: 60.0%). New PPI risk in a preexisting RBBB subset could be stratified by baseline factors. Device selection and implantation strategy considering MS length could prevent new PPI even in these high-risk population.

Sodium-Glucose Cotransporter-2 Inhibitors Stabilize Coronary Plaques in Acute Coronary Syndrome With Diabetes Mellitus.

Sodium-glucose cotransporter-2 inhibitors (SGLT2is) are widely used in cardiology and are effective in treating acute coronary syndrome (ACS). Their effects on unstable plaque in patients with ACS remains unclear. This study aimed to examine the effectiveness of SGLT2is in coronary plaque based on optical coherence tomography (OCT) images and the prognosis of ACS with type 2 diabetes mellitus. This retrospective study included 109 patients in the total cohort and 29 patients in the OCT cohort. Based on SGLT2i administration after ACS, the total cohort was categorized into non-SGLT2i (n = 69) and SGLT2i (n = 40) groups. The OCT cohort had 15 and 14 patients in the non-SGLT2i and SGLT2i groups, respectively. The OCT images of unstable plaque were analyzed in nonstented lesions during ACS catheterization and at the 6-month follow-up. The total cohort was assessed after 1 year for major adverse cardiovascular events, including all-cause mortality, revascularization, cerebrovascular disease, and heart failure hospitalization. SGLT2is improved unstable lesions with a significantly thicker fibrous cap (48 ± 15 µm vs 26 ± 24 µm, p = 0.005), reduced lipid arc (-29 ± 12° vs -18 ± 14°, p = 0.028), higher % decrease in total lipid arc (-35 ± 13% vs -19 ± 18%, p = 0.01), and lower major adverse cardiovascular event incidence (log-rank p = 0.023, hazard ratio 4.72 [1.08 to 20.63]) and revascularization rate (adjusted hazard ratio 6.77 [1.08 to 42.52]) than the non-SGLT2i group. In conclusion, SGLT2is can improve the markers of plaque stability and may improve the prognosis in patients with type 2 diabetes mellitus.

Impact of Mild Paravalvular Regurgitation on Long-Term Clinical Outcomes After Transcatheter Aortic Valve Implantation.

The impact of mild paravalvular regurgitation (PVR) after transcatheter aortic valve implantation (TAVI) remains controversial. We evaluated the impact of mild PVR after TAVI on long-term clinical outcomes. We included patients who underwent TAVI for severe symptomatic aortic stenosis between December 2008 and June 2019 at 2 international centers and compared all-cause death between the group with mild PVR (group 1) and the group with none or trace PVR (group 2). PVR was categorized using a 3-class grading scheme, and patients with PVR ≧ moderate and those who were lost to follow-up were excluded. This retrospective analysis included 1,404 patients (mean age 81.7 ± 6.5 years, 58.0% women). Three hundred fifty eight patients (25.5%) were classified into group 1 and 1,046 patients (74.5%) into group 2. At baseline, group 1 was older and had a lower body mass index, worse co-morbidities, and more severe aortic stenosis. To account for these differences, propensity score matching was performed, resulting in 332 matched pairs. Within these matched groups, during a mean follow-up of 3.2 years, group 1 had a significantly lower survival rate at 5 years (group 1: 62.0% vs group 2: 68.0%, log-rank p = 0.029, hazard ratio: 1.41 [95% confidence interval: 1.04 to 1.91]). In the matched cohort, patients with mild PVR had a significant 1.4-fold increased risk of mortality at 5 years after TAVI compared with those with none or trace PVR. Further studies with more patients are needed to evaluate the impact of longer-term outcomes.

Hemodynamics and Conduction Disturbance After Transcatheter Aortic Valve Implantation With SAPIEN3 Ultra Versus SAPIEN3: The HomoSAPIEN 2 Study.

The optimal percent oversizing (%OS) using the SAPIEN3 Ultra (S3U) weighing the incidence of paravalvular regurgitation (PVR) ≥ mild against the risk of conduction disturbance (CD) is not known. This study sought to define an optimal extent of the annulus area %OS suitable for transcatheter aortic valve implantation with the S3U compared with the SAPIEN3 (S3). A total of 350 patients with the S3U were compared with 606 patients with the S3. Patients were categorized depending on the degree of %OS. PVR ≥ mild was observed in 8.9% of patients with the S3U and in 21.8% of those with the S3 (p <0.001). The S3U demonstrated a sustainably lower incidence of PVR ≥ mild than the S3 in any extent of %OS. There was an inverse proportional relation between the extent of %OS and frequency of PVR ≥ mild in the S3, whereas the S3U group provided little change. The incidences of PVR ≥ mild were steady >5%OS in the S3 (5% to 10%OS: 13.3%, and >10%OS: 12.1%) and >0%OS in the S3U (0% to 5%OS: 5.9%, 5% to 10%OS: 6.0%, and >10%OS: 6.1%). An increasing %OS was independently associated with the occurrence of CD (<0%OS: 9.8%, 0% to 5%OS: 13.1%, 5% to 10%OS: 16.6%, and >10%OS: 19.2%, p = 0.012). The incidence of PVR ≥ mild and/or CD was the lowest (10.1%) in the 0% to 5%OS in patients with the S3U. In conclusion, the HomoSAPIEN2 study suggests that the S3U tolerates a lesser degree of %OS for mitigating PVR ≥ mild than the S3. Minimal %OS, ranging from 0% to 5%, may be optimal for the S3U with balancing the risk of PVR and CD. Trial Identifier: UMIN000040413/URL: https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000046115.