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New conduction disorders remain a frequent complication in current transcatheter aortic valve replacement (TAVR) era. Left bundle branch block (LBBB) occurs early in about 20-30 % of TAVR-patients, persists at 1 month in about 35-45 % of cases and will likely remain thereafter. Third-degree atrioventricular block (AV3B) affects approximately 15 % of patients. Pacemaker dependency gradually decreases throughout follow-up and approximately 25-35 % of patients remain pacemaker dependent at one year. We aimed to review what is currently known about the dynamics of acquired conduction disorders, including extraction of predictors, and how to interpret these dynamics in light of an early discharge policy., Competing Interests: Declaration of competing interest RN: received research grant support from Vifor Pharma and consulting fees from Edwards Lifesciences, Abbott, Boston Scientific NVM: received research grant support from Abbott Vascular, Boston Scientific, Edwards Lifesciences, Medtronic, Daiichi Sankyo and also advisory fees from JenaValve, Anteris, Luma Vision, Pie Medical, Siemens, Abbott Vascular, Boston Scientific, PulseCath BV, Abiomed, Amgen, Medtronic All other authors have no conflicts of interest to report., (Copyright © 2024. Published by Elsevier Inc.)

Objective: To compare early clinical outcomes after transcatheter aortic valve implantation (TAVI) with three consecutive generations of self-expanding valves (SEVs)., Methods: Clinical endpoints of consecutive patients who underwent TAVI with CoreValve, Evolut R or Evolut PRO were included in a prospective database., Results: TAVI was performed with CoreValve (n = 116), Evolut R (n = 160) or Evolut PRO (n = 92). Evolut R and Evolut PRO showed a tendency towards lower permanent pacemaker implantation (PPI) rates compared to CoreValve (CoreValve 27% vs Evolut R 16% vs Evolut PRO 18%, p = 0.091). By multivariable regression analysis CoreValve had a significantly higher risk for PPI (odds ratio (OR) 2.79, 95% confidence interval (CI) 1.31-5.94, p = 0.008) compared to Evolut R, while Evolut R and PRO were similar. Severe paravalvular leakage (PVL) occurred only with CoreValve, but no significant difference was observed in moderate PVL (10% vs 8% vs 6%, p = 0.49). CoreValve had a tendency towards a higher risk for more-than-mild PVL as compared with the Evolut platform (R + PRO) (OR 2.46, 95% CI 0.98-6.16, p = 0.055). No significant differences in all-cause mortality (7% vs 4% vs 1%, p = 0.10), stroke (6% vs 3% vs 2%, p = 0.21) or major vascular complications (10% vs 12% vs 4%, p = 0.14) were observed., Conclusions: TAVI with self-expanding valves was safe, and device iterations may result in a lower need for PPI. More-than-mild PVL seemed to occur less often with repositionable technology., (© 2021. The Author(s).)

Introduction: We aimed to compare conduction dynamics and need for permanent pacemaker implantation (PPI) after CoreValve, Evolut R and PRO (transcatheter aortic valve replacement (TAVR))., Methods: Patients were stratified based on conduction at baseline; Cohort A had normal conduction, Cohort B had conduction abnormalities including atrioventricular (AV)-block, fascicular block or complete bundle branch block. Three different dynamic QRS-patterns were defined: stable QRS-duration, transient QRS-prolongation and persistent QRS-prolongation. We performed multivariable regression analysis to estimate the effect of the three separate transcatheter heart valves (THV's) on need for PPI at 30 days., Results: TAVR was performed with CoreValve (N = 113), Evolut R (N = 157) or Evolut PRO (N = 92). Conduction dynamics were similar between the different THVs. Overall, Evolut R and PRO showed a tendency towards less PPI compared to CoreValve (17% vs. 19% vs. 27%, P = 0.08), which was driven by a lower PPI rate in Cohort A (6% vs. 11% vs. 25%, P = 0.002). Need for PPI was restricted to patients with persistent QRS-prolongation in Cohort A (26/106) but did not correlate with conduction dynamics in Cohort B. In multivariable logistic regression analysis the use of Evolut R (OR 0.38, 95% CI 0.19-0.78, P = 0.008) and PRO (OR 0.41, 95% CI 0.19-0.91, P-value = 0.028) were independently associated with less need for PPI., Conclusion: The newer generations Evolut R and PRO were associated with less PPI compared to CoreValve. Acquired persistent conduction abnormalities predicted PPI after TAVR only in patients with normal conduction at baseline. Our findings may help identify eligible patients for early discharge after Evolut R/PRO TAVR., Competing Interests: Declaration of competing interest HK:no conflicts of interest to declare. LVG:no conflicts of interest to declare. MVW:no conflicts of interest to declare. JO:no conflicts of interest to declare. FZ:no conflicts of interest to declare. ZR:no conflicts of interest to declare. NEF:no conflicts of interest to declare. AM:no conflicts of interest to declare. IK:no conflicts of interest to declare. JD:no conflicts of interest to declare. PDJ:is proctor for Boston Scientific. NVMhas received research grants from Medtronic, Boston scientific, Edwards Lifesciences, Abbott, PulseCath. He is advisor to PulseCath, Ancora, Boston Scientific, Medtronic., (Copyright © 2021 The Author(s). Published by Elsevier Inc. All rights reserved.)

Objectives: To study safety and performance of the MANTA Vascular closure device (VCD) under real world conditions in 10 centers., Background: The MANTA is a novel plug-based device for large bore arteriotomy closure., Methods: We included all eligible patients who underwent transfemoral large bore percutaneous procedures. Exclusion criteria were per operator's discretion and included severe calcification or marked tortuosity of the access vessel, presence of marked obesity/cachexia or a systolic blood pressure above 180 mmHg. The primary performance endpoint was time to hemostasis. Primary and secondary safety endpoints were major and minor access site related vascular complications up to 30 days, respectively. Vascular complications were adjudicated by an independent clinical event committee according to VARC-2 criteria. We performed multivariable logistic regression to estimate the effect of baseline and procedural characteristics on any and major vascular complications., Results: Between February 2018 and July 2019 500 patients were enrolled undergoing Transcatheter aortic valve replacement (TAVR, N = 496), Balloon aortic valvuloplasty (BAV, N = 2), Mechanical circulatory support (MCS, N = 1) or Endovascular aneurysm repair (EVAR, N = 1). Mean age was 80.8 ± 6.6 years with a median STS-score of 2.7 [IQR 2.0-4.3] %. MANTA access site complications were major in 20 (4%) and minor in 28 patients (5.6%). Median time to hemostasis was 50 [IQR 20-120] sec. Severe femoral artery calcification, scar presence in groin, longer procedure duration, female gender and history of hypertension were independent predictors for vascular complications., Conclusion: In this study, MANTA appeared to be a safe and effective device for large bore access closure under real-world conditions., (© 2020 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.)

Background We aimed to compare the rate of neurological events in patients with or without cerebral embolic protection (CEP) during transcatheter aortic valve replacement (TAVR). Methods and Results Data on clinical end points including neurological events ≤30 days post-TAVR were collected for all patients who underwent transfemoral TAVR in 2 academic tertiary care institutions. Patients were matched through propensity scoring, which resulted in 333 pairs of patients with versus without CEP out of a total of 831 consecutive patients. The median age was 81 (76-85) years, and the median logistic EuroScore was 14% (9%-20%). The CEP group experienced less neurological events at 24 hours (1% versus 4%; P=0.035) and at 30 days (3% versus 7%; P=0.029). There were significantly more disabling strokes in unprotected patients at 30 days (1% versus 4%; P=0.039). CEP was associated with significantly fewer neurological events at 24 hours after TAVR (odds ratio, 0.20; 95% CI, 0.06-0.73; P=0.015) by multiple regression analysis, while age and valve type did not contribute significantly. Overall, 67% (2 of 3) in the CEP versus 83% (10 of 12) in the non-CEP cohort experienced neurological events in protected areas (ie, not dependent on the left vertebral artery). Conclusions The use of filter-based CEP during TAVR was associated with less neurological events, especially in CEP-protected brain territories.

Transcatheter aortic valve implantation (TAVI) is a less invasive aortic valve replacement technique and is indicated for patients with symptomatic severe aortic stenosis and a high operative risk. Cerebral embolisation seems inherent to TAVI, as illustrated by the consistent appearance of new brain lesions on post-procedural MRI studies. Embolic protection devices may capture or deflect embolised material en route to the brain and thus reduce TAVI-related brain injury. Histopathology studies of captured debris revealed a diverse aetiology including recent or organised thrombotic material, tissue originating from the aortic valve, atherosclerotic plaques or myocardium and foreign body components. In this overview we provide a perspective on current evidence and implications for embolic protection devices in the dynamic TAVI field., Competing Interests: Conflicts of interest: NMDAvM has received research grants from Claret Medical.

Introduction: Cerebral Embolic Protection Device (CEPD) captures emboli during Transcatheter Aortic Valve Replacement (TAVR). With recently published pivotal trials and multiple cohort studies reporting new data, there is a need to re-calibrate available statistical evidence. Methods: A systematic literature search was conducted across databases from inception till February 2023. Dichotomous outcomes were pooled using Odds Ratio (OR), while continuous outcomes were pooled using Standardized Mean Difference (SMD) along with 95% corresponding intervals (95% CIs). Results: Data was included from 17 studies (7 RCTs, 10 cohorts, n = 155,829). Use of CEPD was associated with significantly reduced odds of stroke (OR = 0.60, 95% CI = 0.43–0.85, p = 0.003). There was no significant difference in disabling stroke (p = 0.25), non-disabling stroke (p = 0.72), and 30-day mortality (p = 0.10) between the two groups. There were no significant differences between the two groups for Diffusion-Weighted Magnetic Resonance Imaging (DW-MRI) findings, acute kidney injury, risk of pacemaker implantation life-threatening bleed, major bleed, minor bleed, worsening National Institute of Health Stroke Scale (NIHSS), modified Rankin Scale (mRS) and vascular complications (p > 0.05). Conclusions: The use of CEPD during TAVR reduced the incidence of all-stroke (p = 0.003); however, there were no significant differences in any of the other pooled outcomes (p > 0.05). Registration: The protocol of this meta-analysis was registered with the Open Science framework [] before data acquisition was started. [ABSTRACT FROM AUTHOR]

Introduction: Aortic stenosis is the most common primary valve disease and requires invasive treatment. Transcatheter aortic valve implantation (TAVI) from a transfemoral access is a routine intervention worldwide. Aim: To investigate the correlation between external iliac artery diameter (EIAD) indexed to body surface area (BSA) (EIAD-BSA) and access site complications in patients undergoing TAVI via transfemoral access (TF) (TF-TAVI). Material and methods: Patients underwent TF-TAVI in 2017–2019 at the Upper-Silesian Medical Center in Katowice. Based on the preoperative multi-slice computed tomography (MSCT), pre-specified measurements of the ilio-femoral vessels were performed. The results were indexed to BSA and body mass index (BMI). Complications after TAVI were defined by Valve Academic Research Consortium 3 (VARC-3). The primary outcome regarding the adverse events after TAVI was the composite of access site complications requiring surgical intervention or blood transfusion. Results: The registry included 193 unselected patients with severe symptomatic aortic stenosis. Vascular and access-related complications including bleeding occurred in 17.1% of patients. Major TAVI access site complications (VARC-3) were reported in 5.7% of patients, while minor complications (VARC-3) occurred in 2.6%. EIAD-BSA demonstrated a positive correlation with the access site complications primary endpoint. Patients with greater EIAD-BSA had a numerically higher number of access site adverse events requiring surgical intervention or blood transfusion: n = 12 (5%) vs. n = 4 (4%), p = 0.011. Conclusions: External iliac artery diameter indexed to BSA could be an underestimated indicator of unfavorable outcomes after TF-TAVI, predicting periprocedural access site complications. [ABSTRACT FROM AUTHOR]

Transcatheter aortic valve implantation (TAVI) is the standard of care for selected patients with severe aortic stenosis, irrespective of the surgical risk. Over the last two decades of TAVI practice, multiple limitations were identified. In addition, the extension of TAVI into a wider patient spectrum created new challenges. This review provides an overview of emerging transcatheter heart valves (THVs) beyond the approved contemporary THVs for the treatment of aortic stenosis. The incidence of degenerative aortic stenosis is expected to increase with more aging of the population. Therefore, TAVI needs to meet this increase in the number of patients indicated for aortic valve replacement alongside a wide and complex anatomical variability. An increasing number of Aortic THVs are available in the market. This includes upgraded iterations of contemporary devices and innovative devices developed by emerging manufacturers. The new devices aim for the reduction or elimination of undesirable outcomes like paravalvular leakage and conduction disturbances requiring permanent pacemaker implantation. Alternatively, emerging THVs should provide feasibility regarding yet unproven TAVI indications like Bicuspid aortic valve, aortic regurgitation, or very large anatomy. Furthermore, some of the emerging THVs are designed to tackle the long-term durability issue of biological valves. [ABSTRACT FROM AUTHOR]

Objectives: To perform a systematic review and meta‐analysis of the techniques and outcomes associated with percutaneous decannulation of venoarterial extracorporeal membrane oxygenation (VA–ECMO) using the Manta vascular closure device. Background: Peripheral VA–ECMO can be used to treat critically ill patients with conditions such as refractory cardiogenic shock. After percutaneous implantation of VA–ECMO, VA–ECMO can also be decannulated completely percutaneously by using a vascular closure device. The Manta vascular closure device is a dedicated device used in the closure of large‐bore arteriotomies by sandwiching the arteriotomy with an intra‐arterial toggle and an extraluminal collagen plug. Methods: We performed a thorough literature search using various electronic databases. We included studies that reported outcomes after peripheral femorofemoral VA–ECMO decannulation with the Manta vascular closure device. We performed a meta‐analysis of proportions on outcome measures, including technical success, bleeding complications, vascular complications, wound complications, major amputation, and procedural‐related deaths. Results: We included seven studies with a total of 116 patients. The overall technical success of percutaneous decannulation of VA–ECMO with the Manta vascular closure device was 93.7%. The overall incidence of bleeding, vascular and wound complications was 1.7%, 13.8%, and 3.4%, respectively. No patient required lower limb amputation or died due to VA–ECMO decannulation. Conclusion: Percutaneous decannulation with the Manta vascular closure device is an effective and safe procedure that should be considered in suitable patients on VA–ECMO. [ABSTRACT FROM AUTHOR]

Transfemoral transcatheter aortic valve replacement is the preferred primary access route whenever possible. Despite advancements in expertise and delivery system profiles, complications associated with the primary femoral access still significantly affect procedural morbidity and outcomes. The current standard for accurate main access planning involves proper preprocedural evaluation guided by computed tomography. Several baseline clinical and anatomical features serve as predictors for the risk of vascular injury occurring during or after transcatheter aortic valve replacement. In this paper, we aimed at reviewing the most up-to-date knowledge of the topic for a safe transfemoral access approach according to a paradigm we have called "PIGTAIL.", (© 2024 The Author(s). Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.)

Background: Embolization of debris can complicate transcatheter aortic valve implantation (TAVI) causing stroke. Cerebral embolism protection (CEP) devices can divert or trap debris., Purpose: To evaluate the efficacy of CEP during TAVI vs the standard procedure., Data Sources: PubMed, SCOPUS and DOAJ 1/01/2014-04/12/2023., Study Selection: Randomized and observational studies comparing CEP versus standard TAVI, according to PRISMA., Primary Outcome: stroke., Secondary Outcomes: death, bleeding, vascular access complications, acute kidney injury and infarct area., Data Extraction: Two investigators independently assessed study quality and extracted data., Data Synthesis: Twenty-six articles were included (540.247 patients). The primary endpoint was significantly lower (RR = 0.800 95%CI:0.682-0.940; p = 0.007) with CEP. Similarly, death rates were significantly lower with CEP (RR = 0.610 95%CI:0.482-0.771; p < 0.001). No difference was found for bleeding (RR = 1.053 95%CI:0.793-1.398; p = 0.721), vascular complications (RR = 0.937 95%CI:0.820-1.070; p = 0.334) or AKI (RR = 0.982 95%CI:0.754-1.279; p = 0.891)., Conclusions: Use of CEP during TAVI is associated with improved outcomes. Future studies will identify patients who benefit most from CEP., (© 2024 The Authors. European Journal of Clinical Investigation published by John Wiley & Sons Ltd on behalf of Stichting European Society for Clinical Investigation Journal Foundation.)

Background: Vascular complications increase morbidity and mortality in transcatheter aortic valve replacement (TAVR). Data involving suture-based percutaneous vascular closure devices (VCDs) have been extensive. Although promising, data regarding the efficacy and safety of the MANTA VCD (Teleflex) are scarce. We sought to assess the safety and effectiveness of the MANTA device in a real-life unselected cohort of patients undergoing transfemoral-TAVR (TF-TAVR)., Methods: This single-center retrospective observational study included a cohort of consecutive patients with severe aortic stenosis (AS) treated by our team using TAVR between January 2020 to December 2022. The primary outcome measure was access-related major and minor vascular complications according to the Valve Academic Research Consortium (VARC-3) definition criteria., Results: From January 2020 to December 2022, a total of 347 patients underwent TF-TAVR were treated using the MANTA 18 Fr VCD system for vascular closure. Mean age was 82.4 ± 6.1 years (56-98 years). There were no significant differences in preoperative and procedural characteristics between patients with and without VCD-related major vascular complications. Access site-related major and minor vascular complications occurred in 20 of 347 patients (5.7%). Overall, major vascular complications occurred in 5 patients (1.4%) and device failure was seen in 17 patients (4.9%)., Conclusion: This French real world evaluation of large-bore arteriotomy closure in TF-TAVR indicated that MANTA VCD is a feasible alternative with an acceptable low rate of access-site-related complications., (© 2024 Wiley Periodicals LLC.)

Introduction: Transcatheter aortic valve implantation (TAVI) has matured to the treatment of choice for most patients with aortic stenosis (AS). We sought to identify trends in patient and procedural characteristics, and clinical outcomes in all patients who underwent TAVI between 2005 and 2020. Methods: A single-centre analysis was performed on 1500 consecutive patients who underwent TAVI, divided into three tertiles (T) of 500 patients treated between November 2005 and December 2014 (T1), January 2015 and May 2018 (T2) and June 2018 and April 2020 (T3). Results: Over time, mean age and gender did not change (T1 to T3: 80, 80 and 79 years and 53%, 55% and 52% men, respectively), while the Society of Thoracic Surgeons risk score declined (T1: 4.5% to T3: 2.7%, p < 0.001). Use of general anaesthesia also declined over time (100%, 24% and 1% from T1 to T3) and transfemoral TAVI remained the default approach (87%, 94% and 92%). Median procedure time and contrast volume decreased significantly (186, 114 and 56 min and 120, 100 and 80 ml, respectively). Thirty-day mortality (7%, 4% and 2%), stroke (7%, 3% and 3%), need for a pacemaker (19%, 22% and 8%) and delirium (17%, 12% and 8%) improved significantly, while major bleeding/vascular complications did not change (both approximately 9%, 6% and 6%). One-year survival was 80%, 88% and 92%, respectively. Conclusion: Over our 15 years' experience, patient age remained unchanged but the patient risk profile became more favourable. Simplification of the TAVI procedure occurred in parallel with major improvement in outcomes and survival. Bleeding/vascular complications and the need for pacemaker implantation remain the Achilles' heel of TAVI. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

The evidence regarding the impact of cerebral embolic protection devices (EPDs) on outcomes following transcatheter aortic valve replacement (TAVR) is limited. The objective of this study was to evaluate in-hospital outcomes with the use of cerebral EPDs in TAVR. We performed a comprehensive EMBASE and PUBMED search to investigate randomized control studies or propensity score-matched retrospective studies which assessed patients undergoing TAVR with or without EPD up to April 2021. Endpoints of interest were in-hospital mortality, stroke, acute kidney injury, pacemaker implantation, major bleeding, vascular complication, length of stay. Ten studies involving 173,002 patients with EPD (n = 16,898, 9.8%) and those without (n = 156,104, 90.2%) fulfilled the inclusion criteria. The use of EPD was associated with significantly lower risk of in-hospital stroke (odds ratio [95% confidential interval]: 0.64 [0.46; 0.89]), but similar rate of in-hospital mortality (odds ratio [95% confidential interval]: 0.75 [0.54; 1.05]). No differences were observed in acute kidney injury, pacemaker implantation, major bleeding, vascular complication, length of stay. EPD during TAVR was associated with lower in-hospital stroke but did not affect procedural complications and length of stay. [ABSTRACT FROM AUTHOR]

Transcatheter aortic valve implantation (TAVI) is a common treatment for patients with aortic valve stenosis and a high surgical risk. While the risk of complications has decreased, ischaemic stroke remains a concern, and new cerebral lesions have been linked to delirium after TAVI. Neurocognitive changes can also occur after TAVI. Different catheters have been developed to minimize neurological complications, but their effectiveness in preventing stroke is still being studied. The CAPITA study aims to investigate the effects of TAVI on cognitive functioning and cerebral blood flow, with results expected by the end of 2023. This study will contribute to our understanding of the relationship between cardiac function, cerebral blood flow, and cognitive functioning. [Extracted from the article]

Objectives: We herein aimed to evaluate technical feasibility of transaxillary (Tax) transcatheter aortic valve implantation (TAVI) utilizing a novel vascular closure device with a resorbable collagen plug and absence of suture material. Methods: Between 05/2018 and 8/2018, eight patients (76.0 ± 5.9 years, 62.5% male, logEuroSCORE I 23.6 ± 4.7) received Tax-TAVI using the MANTA™ vascular closure device. Implanted transcatheter heart valves consisted of Edwards Sapien 3, NVT Allegra, Medtronic CoreValve EvolutR and SJM Portico. Results: Puncture location depth was variable (3.5–7.5 cm). The left subclavian artery was used in five cases, the right subclavian artery in three cases. Low-pressure balloon-angioplasty for vessel closure was performed in 5/8 patients. VARC-2 defined device success was met in all patients. Major access site complication occurred in one patient with aneurysma spurium of the subclavian artery and consecutive stent implantation on postoperative day 5. Conclusion: The MANTA™ device is applicable in Tax-TAVI, with potential particular advantages regarding easiness of use and marked access for subsequent interventions in case of vascular complications. Before conclusions regarding clinical efficacy and safety can be made, the device has to be evaluated in larger patient cohorts. [ABSTRACT FROM AUTHOR]