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.

Long-term improvement of symptoms of angina pectoris after successful revascularization of coronary artery chronic total occlusions.

Objectives. To compare long-term angina pectoris relief of successful versus failed percutaneous coronary intervention of chronic total occlusions (CTO PCI). Background. Previous studies demonstrate better short-term angina pectoris relief of CTO PCI than with optimal medical treatment (OMT), however, data on the long-term effects are lacking. Methods. 295 patients undergoing CTO PCI were analyzed retrospectively, with a follow-up evaluation of symptoms of angina pectoris and all-cause death one to four years after the intervention. The primary outcome was long-term relief of symptoms of angina pectoris. Secondary outcomes included a composite of major adverse cardiovascular events (MACE), including all-cause death, myocardial infarction, stroke, and later target vessel revascularization (TVR). At follow-up, patients were interviewed for symptoms of angina pectoris at 1, 6, 12, and 22 to 48 months after the intervention. Results. CTO PCI was successful in 225 (76%) patients and failed in 70 (24%) patients. Short-term (six months) relief of angina pectoris was observed in both groups, but only the successful CTO PCI group showed long-term relief. The Kaplan-Meier curves of all-cause death did not differ between the groups (p = .715). The final follow-up was a mean (range) of 37 (25 to 44) months after the intervention in the successful CTO PCI group, and 33 (28 to 48) months in the failed CTO PCI group. Conclusions. Successful CTO PCI is associated with better long-term relief of symptoms of angina pectoris compared to failed CTO PCI.

Predictors of conduction disturbances after transcatheter aortic valve implantation with balloon-expandable valve for bicuspid aortic valve stenosis.

INTRODUCTION: Implantation depth and membranous septum (MS) length have been established as the predictors of new-onset conduction disturbance (CD) after transcatheter aortic valve replacement (TAVR) for tricuspid aortic valve (TAV) stenosis. However, little is known about the predictors with bicuspid aortic valve (BAV). This study investigated the role of MS length and implantation depth in predicting CD following TAVR with a balloon-expandable valve in patients with BAV. METHODS: This retrospective study analyzed 169 patients who underwent TAVR for BAV with balloon-expandable valve, and TAV cohort was established as a control group using propensity score (PS) matching. The primary endpoints were in-hospital new permanent pacemaker implantation (PPI) and new-onset CD (the composite outcome of new-onset left bundle branch block and new PPI). RESULTS: PPI developed in 14 patients (8.3%) and new-onset CD in 37 patients (21.9%) in the BAV cohort. Multivariate analysis revealed severe left ventricle outflow tract (LVOT) calcification (odds ratio [OR]: 5.83, 95% confidence interval [CI]: 1.08-31.5, p = .0407) and implantation depth-MS length (OR: 1.30, 95% CI: 1.12-1.51, p = .0005) as the predictors of new-onset CD within the BAV cohort. The matched comparison between BAV and TAV groups showed similar MS length (3.0 vs. 3.2 mm, p = .5307), but valves were implanted more deeply in the BAV group than in the TAV group (3.9 vs. 3.0 mm, p < .0001). New-onset CD was more frequent in patients who had BAV (22.3% vs. 13.9%, p = .0458). CONCLUSION: The implantation depth-MS length, and severe LVOT calcification predicted new-onset CD following TAVR in BAV with balloon-expandable valve. Among BAV patients, valves were implanted more deeply compared to TAV patients. High deployment technique could be considered to avoid new-onset CD in BAV anatomy.

Incidence and Predictors of Access Site Vascular Complications Following Ultrasound-Guided MANTA Closure Deployment.

PURPOSE: There is no report on the reproducibility of the ultrasound-navigated MANTA deployment (US-MANTA) technique and little is known about predictors for US-MANTA-related vascular complication (VC). This study aimed to assess the incidence and predictors of access-site VC using the US-MANTA technique and report insights of MANTA-related VC from consecutive cases following large-bore arteriotomy. MATERIALS AND METHODS: Consecutive patients who underwent transfemoral transcatheter aortic valve replacement with the US-MANTA technique from November 2018 to February 2020 were evaluated. MANTA-related VC was defined as access-site complications leading to major or minor VCs based on Valve Academic Research Consortium-2 criteria. RESULTS: Among 378 patients, 23 cases (6.1%) of MANTA-related VC (major VC: n=7 [1.9%], minor VC: n=16 [4.2%]) were identified. No significant difference was observed in the incidence of MANTA-related VC over the observational period (first quartile: 5.3%, second: 5.4%, third: 7.4%, and fourth: 6.3%, p>.50). In 7 patients with MANTA-related major VC, 4 (57.1%) of complications resulted from incomplete apposition of the toggle due to anterior wall calcification of the common femoral artery (CFA). Anterior calcification of the CFA determined by computed tomography was identified as an independent predictor of MANTA-related VCs. CONCLUSIONS: The US-MANTA technique sustainably provides a low rate of access-site VCs following large-bore arteriotomy. Incomplete apposition of the toggle due to anterior calcification of the CFA may lead to ongoing vascular and bleeding complications.

Hemodynamic comparison of transcatheter aortic valve replacement with the SAPIEN 3 Ultra versus SAPIEN 3: The HomoSAPIEN registry.

OBJECTIVES: The study aims to compare the hemodynamic and clinical outcomes of the SAPIEN 3 Ultra (S3-Ultra) with the SAPIEN 3 (S3) system in patients who underwent transfemoral transcatheter aortic valve replacement (TF-TAVR). BACKGROUND: The new balloon-expandable S3-Ultra system incorporates new features to reduce paravalvular leakage (PVL). However, the data after the S3-Ultra implantation is very limited. METHODS: A total of 282 consecutive patients who underwent TF-TAVR with the S3-Ultra and the S3 were evaluated. The primary outcome of this study was to compare the incidence of ≥mild PVL after the S3-Ultra and S3 implantation. RESULTS: Between June 2017 and November 2019, 141 patients with the S3-Ultra and 141 patients with the S3 were identified with similar baseline and preprocedural imaging characteristics (mean age: 79.6 ± 6.7 years and mean aortic annulus area: 492.5 ± 91.2 mm2 ). In total, 83 patients (29.4%) were treated with 29-mm valve. Predischarge echocardiography demonstrated a significantly lower incidence of ≥mild PVL (the total cohort: 7.2 vs. 22.3%, p < .001, and the cohort excluding 29-mm valve: 4.0 vs. 21.4%, p = .03) for the S3-Ultra. The S3-Ultra system, especially 20-, 23-, and 26-mm valve, was associated with significantly lower risk of ≥mild PVL compared with the S3 system in multivariate analysis. There were no significant differences in clinical outcomes at 30-day between these groups, except for the lower incidence of major vascular complication (4.5 vs. 11.4%, p = .05) in patients with the S3-Ultra. CONCLUSIONS: In this registry, the S3-Ultra system performed superiorly to the S3, as demonstrated by reduced ≥mild PVL, with comparable safety.

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.

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.

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.

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.

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.

Early Hemodynamic Outcomes in Self-Expandable Valves: Comparison of ACURATE Neo Versus ACURATE Neo2.

BACKGROUND: Comparisons of hemodynamic results between ACURATE Neo and ACURATE Neo 2, which have updated outer sealing skirts, are limited. This retrospective study aimed to demonstrate the differences in hemodynamic outcomes between the two transcatheter heart valves (THVs). METHODS: We included 449 patients who underwent transfemoral transcatheter aortic valve replacement (TAVR) with either ACURATE Neo2 (n = 100) or ACURATE Neo (n = 348) between January 2016 and November 2021. The primary endpoint was the incidence of moderate or severe paravalvular leakage (PVL). The mean aortic pressure gradient (APG), peak aortic velocity (AV), and early clinical outcomes were assessed as secondary outcomes. RESULTS: In the propensity-score matching comparison (94 pairs), there were no significant differences in the incidence of moderate or severe PVL (4.3 % in Neo2 group vs. 8.5 % in Neo group, p = 0.233), and peak AV and mean APG were significantly higher in Neo2 group (Peak AV: 2.1 ± 0.4 vs. 1.9 ± 0.5 m/s, p = 0.003; mean APG: 10.6 ± 4.8 vs. 9.0 ± 6.1 mmHg, p = 0.045). In the multivariate logistic regression analysis, the THV type (ACURATE Neo2) was not an independent predictor of moderate or severe PVL. CONCLUSION: The incidence of moderate or severe PVL did not significantly differ between TAVR with ACURATE Neo2 and ACURATE Neo; however, it was numerically lower in ACURATE Neo2. In contrast, the Neo2 group had a higher residual mean APG and peak AV. A larger study with long-term follow-up is warranted to assess the clinical relevance of these findings.

Medium-term outcome of transcatheter aortic valve replacement in mucopolysaccharidosis type I-HS (Hurler-Scheie syndrome).

Mucopolysaccharidoses (MPSs) are inherited metabolic diseases characterized by the deficiency of lysosomal enzymes and the accumulation of glycosaminoglycans in various organs, including the heart. In particular, aortic valve disease causes high morbidity and mortality rates, and sometimes requires surgical aortic valve replacement (SAVR) at a young age. Although transcatheter aortic valve replacement (TAVR) for severe aortic stenosis (AS) in surgical high-risk patients is a well-established treatment, there are few reports of TAVR in MPS and medium- and long-term outcomes are not known. We present a case of severe AS in a MPS patient with high risk for SAVR who was successfully treated with TAVR and has shown a fine medium-term result. A 40-year-old woman with MPS type I-HS (Hurler-Scheie syndrome) receiving enzyme replacement therapy as a systemic treatment had complained of syncope and worsening dyspnea, and she was diagnosed with severe AS. The patient had a history of temporary tracheotomy because of the difficulty of endotracheal intubation. Considering risk for general anesthesia, TAVR was performed under local anesthesia. She has improved symptoms for one-and-a-half years. TAVR for severe AS in MPS would be an alternative option for surgical high-risk patients and can demonstrate preferable medium-term outcomes combined with systemic therapies. Learning objective: Mucopolysaccharidoses (MPSs) are metabolic diseases affecting various organs. The MPS patients requiring surgical aortic valve replacement (SAVR) for severe aortic stenosis (AS) often have a high surgical risk. However, in MPS, transcatheter aortic valve replacement (TAVR) could be an alternative procedure to SAVR. We report a MPS patient treated with TAVR showing a preferable medium-term outcome. We suggest that TAVR for severe AS in MPS is an acceptable treatment option.

A case of chronic total occlusion in popliteal artery recanalized by double snare piercing technique.

BACKGROUND: Although majority of cases with chronic total occlusion (CTO) in femoro-popliteal lesion were treated with antegrade approach only, some lesions require alternative approach due to its complexity. Bi-directional approach is useful on endovascular therapy (EVT) for CTO; however guidewire passage through the lesion is impossible in some challenging cases. The present case shows a successful re-entry technique utilizing two snare catheters from an antegrade and retrograde access site (double snare piecing technique). CASE PRESENTATION: A 79-year-old woman with right leg intermittent claudication (Rutherford category IV), who had undergone unsuccessful EVT for popliteal CTO, required another EVT for the worsening symptom. Following the failed conventional crossing technique (wire knuckle technique, intravascular-ultrasound-guided wiring, and controlled antegrade and retrograde subintimal tracking technique), two snare catheters were placed and the snare loops were pierced by a puncture needle percutaneously. After an 0.014 wire was inserted into the needle, the needle was withdrawn. The wire was pulled from the retrograde side and was externalized. Then, the antegrade snare catheter was pulled and externalized, to make the wire across the lesion. After that, a microcatheter was advanced along the externalized wire from the retrograde side and cross the lesion. The wire was replaced with a new wire, which completely created pull-through system. After the hemostasis by balloon inflation and lesion preparation, this procedure was completed with an endoluminal-covered stent and two inter-woven stents. The re-entry site was covered by the inter-woven stent. Her symptoms improved after the procedure, and the lesion has not developed restenosis at 2-years follow-up. CONCLUSIONS: This re-entry technique of puncturing two snare loops (double snare piercing technique) might be effective for achieving successful passage through challenging femoropopliteal CTO cases.

Conduction Disturbance After Transcatheter Aortic Valve Implantation With Self- or Balloon-Expandable Valve According to the Implantation Depth.

Membranous septum (MS) length, in conjunction with implantation depth (ID), is known as a determinant of conduction disturbance (CD) after transcatheter aortic valve implantation (TAVI). However, its impact might be dissimilar among valve types because each valve has a different platform. This study sought to investigate the different impacts of ID and MS length on the new-onset CD between ACURATE neo and SAPIEN 3. This study included patients without a previous permanent pacemaker implantation who underwent TAVI with ACURATE neo and SAPIEN 3 and divided them into 2 groups based on the ID according to MS length (deep and shallow implantation group). Deep implantation was defined as transcatheter heart valve implantation deeper than MS length. The primary endpoint was new-onset CD (new permanent pacemaker implantation or new-onset complete left bundle branch block). A total of 688 patients (deep implantation: n = 373, shallow implantation: n = 315) were identified as a study cohort. New-onset CD developed more frequently in the deep implantation group (16.6% vs 7.0%; p = 0.0001). Deep implantation was revealed as a predictor of new-onset CD. Moreover, deep implantation was significantly associated with new-onset CD after SAPIEN 3 implantation but not after ACURATE neo. Among patients with MS shorter than 2 mm, ACURATE neo was superior in terms of avoiding new-onset CD. In conclusion, the deep implantation was associated with new-onset CD after TAVI with SAPIEN 3 but not with ACURATE neo. These results may impact device selection in patients with a preexisting high risk of CD.

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.

Incidence, clinical course, and risk factors in the development of femoral pseudoaneurysm after atrial fibrillation ablation.

Background: Previous studies have revealed the risk factors for femoral pseudoaneurysms (FPA). Most data on FPA are based on coronary and peripheral interventions, with limited studies focusing on atrial fibrillation (AF) ablation. However, patient backgrounds, anticoagulation regimens, and vascular access methods differ. In addition, a standard for managing FPA after AF ablation remains elusive due to the difficult nature of achieving thrombosis in pseudoaneurysms. Methods: This single-center, retrospective, observational study included 2805 consecutive patients who underwent AF ablation between January 2016 and December 2021. All patients underwent femoral artery and vein punctures. Puncture sites were checked 1 day post-procedure. Results: A total of 23 FPA patients were identified during the study period. Multivariate logistic regression analysis showed that hypertension (odds ratio 4.66, 95% confidence interval: 1.38-15.71; p = .0032) and warfarin use (odds ratio 3.83, 95% confidence interval: 1.40-10.45; p = .021) were significantly associated with the occurrence of FPA. The compression success rate was low (22%). There were nine and six patients in the endovascular treatment (EVT) and ultrasound-guided thrombin injection (UGTI) groups, respectively. The success rates were 100% and 84% in the EVT and UGTI groups, respectively. The length of hospital stay after FPA treatment was 2.1 days in the EVT group and 1.3 days in the thrombin group. Conclusion: We must be careful about post-procedural FPA, especially for hypertension and warfarin-using patients. Treatment of pseudoaneurysms with anticoagulants is unlikely to achieve hemostasis, and an early switch to invasive treatments, such as EVT, should be considered.