Transfemoral Transcatheter Aortic Valve Replacement Research Articles

Transcatheter aortic valve replacement in China - a review of the available evidence.

This paper discusses aortic stenosis (AS) in China, emphasising the role of transcatheter aortic valve replacement (TAVR) in treating AS in an ageing population. AS characteristics, its treatment and the clinical outcomes of transfemoral TAVR in Chinese patients are described via a systematic review. AS affects >1% of the Chinese population aged ≥65 years, with degenerative AS predominating over rheumatic AS among this age group. Chinese patients often have high aortic valve (AV) calcification with bicuspid AV morphology. In 2021, 38,000 surgical aortic valve replacements (SAVR) were reported in China, while the number of TAVR increased from 293 in 2017 to 7,357 in 2021. There are four self-expanding valves and one balloon-expandable SAPIEN 3 valve available in China. Among them, the Venus A-Valve is the most studied and widely used, whereas limited data are available for VitaFlow, TaurusOne, and SAPIEN 3. Notably, 10.0-16.5% of Venus A-Valve recipients and 0.2% of SAPIEN 3 recipients required multiple valve implantations. The rates of 30-day paravalvular leakage were 0-11.7%/0% for Venus A-Valve, 2.0%/0% for VitaFlow, and 0%/0% for SAPIEN 3, for moderate and severe leakage, respectively. Thirty-day all-cause mortality rates were 3.7-10.0% for Venus A-Valve, 0.9% for VitaFlow, and 0-3.2% for SAPIEN 3. One-year all-cause mortality rates were 5.9-13.6% for Venus A-Valve, 0-4.5% for VitaFlow, 6.7% for TaurusOne, and 6.2% for SAPIEN 3. The Venus A-Valve indicated lower 30-day permanent pacemaker implantation (PPI) rates (7.4-20.5%) than VitaFlow and TaurusOne. Outcomes for patients with bicuspid or tricuspid aortic valves were similar. AS is rising among the elderly Chinese population; SAVR is common, and TAVR is increasing. Limited device comparisons exist, but the Venus A-Valve seems to have lower PPI rates, and SAPIEN 3 has low 30-day mortality in China.

Outcomes of transfemoral TAVR using two new-generation devices in patients with horizontal aorta.

Challenging anatomies and comorbidities have impact on success in transcatheter aortic valve replacement (TAVR). There is controversy whether the extent of the aortic angle (AA) has an impact on procedural outcomes. Matched comparative outcome data of new generation transcatheter heart valves (THVs) in horizontal aorta (HA) are scarce. A total of 1582 patients with severe native aortic stenosis (AS) treated with the SAPIEN3 Ultra (Ultra; n = 526) or ACURATE Neo2 (Neo2; n = 1056) THVs from January 2017 to January 2023 were analyzed. Patients with non-horizontal aortas (AA < 51.7°, n = 841) were excluded. The population was matched by 1-to-1 nearest-neighbor matching (Ultra, n = 246; Neo2, n = 246). Clinical and procedural outcome were evaluated according to VARC-3 recommendations. Technical success (93.1% vs. 94.7%, p = 0.572) was high after Ultra and Neo2. Device success (80.5% vs. 89.8%, p = 0.05) was inferior with Ultra. Neo2 reveals superior hemodynamic properties with lower rate of severe prosthesis patient mismatch (12.0% vs. 3.7%, p = 0.001) and elevated gradients ( 20 mmHg: 11.9% vs. 1.7%, p < 0.001). Ultra showed a lower rate of relevant paravalvular regurgitation ( mild paravalvular regurgitation or Valve-in-Valve due to paravalvular regurgitation: 0.0% vs. 3.7%, p = 0.004). The rate of procedural bailout maneuvers (0.8% vs. 0.4%, p = 1.000) and thirty-day all-cause mortality (1.3% vs. 2.2%, p = 0.496) was similar. Transfemoral TAVR in patients with severe aortic stenosis and HA, using the balloon expandable Sapien3 Ultra and self-expanding ACURATE Neo2 prosthesis, is feasible and safe. Therefore, valve selection between these platforms should be made irrespective of the aortic angle by a team experienced with both valves based on their specific advantages. Large, randomized trials in this sub-group of patients would be necessary to compare long term outcomes.

Impact of Cerebral Embolic Protection Devices on Disabling Stroke After TAVR: Updated Results From the STS/ACC TVT Registry.

Cerebral embolic protection devices (EPDs) were developed to mitigate the risk of stroke during transcatheter aortic valve replacement (TAVR), but their benefit remains unproven. In the PROTECTED-TAVR trial (Stroke Protection With Sentinel During Transcatheter), EPD use did not reduce periprocedural stroke (primary study outcome) but led to a 62% reduction in the secondary end point of disabling stroke. Given these results, the impact of EPDs during TAVR remains unclear. We used STS/ACC TVT registry data to examine the association between EPD use and a proxy for disabling stroke among transfemoral TAVR patients between January 2018 and June 2023. The primary outcome was in-hospital disabling stroke-defined as stroke associated with either in-hospital death or discharge to a nonhome location. We evaluated the association between EPD use and disabling stroke using instrumental variable analysis with a site-level preference for EPD use as the instrument-a quasi-experimental approach that can support causal inference. In addition, we performed a propensity score-based comparison using overlap weighting as a secondary analysis. The study population consisted of 414 649 patients of whom 53 389 (12.9%) received an EPD. The unadjusted rate of in-hospital disabling stroke was 0.7% among the EPD group and 0.9% in the no-EPD group. EPD use was associated with a reduction in disabling stroke in both instrumental variable analysis (relative risk, 0.87 [95% CI, 0.73-1.00]) and propensity-weighted analysis (odds ratio, 0.79 [95% CI, 0.70-0.90]) but was not associated with a reduction in nondisabling stroke. In subgroup analyses, the benefit of EPD was greater among those with versus without prior stroke (Pinteraction<0.05 for both instrumental variable and propensity-weighted analyses). In the largest study to date, among patients undergoing TAVR, EPD use was associated with a small, borderline significant reduction in stroke associated with death or discharge to a nonhome location (a proxy for disabling stroke) that is likely to be causal in nature. Taken together with previous mechanistic and clinical studies, these findings provide credible evidence that EPDs benefit patients undergoing TAVR.

Machine Learning of Cardiac Anatomy and the Risk of New-Onset Atrial Fibrillation After TAVR

BackgroundNew-onset atrial fibrillation (NOAF) occurs in 5% to 15% of patients who undergo transfemoral transcatheter aortic valve replacement (TAVR). Cardiac imaging has been underutilized to predict NOAF following TAVR. ObjectivesThe objective of this analysis was to compare and assess standard, manual echocardiographic and cardiac computed tomography (cCT) measurements as well as machine learning–derived cCT measurements of left atrial volume index and epicardial adipose tissue as risk factors for NOAF following TAVR. MethodsThe study included 1,385 patients undergoing elective, transfemoral TAVR for severe, symptomatic aortic stenosis. Each patient had standard and machine learning–derived measurements of left atrial volume and epicardial adipose tissue from cardiac computed tomography. The outcome of interest was NOAF within 30 days following TAVR. We used a 2-step statistical model including random forest for variable importance ranking, followed by multivariable logistic regression for predictors of highest importance. Model discrimination was assessed by using the C-statistic to compare the performance of the models with and without imaging. ResultsForty-seven (5.0%) of 935 patients without pre-existing atrial fibrillation (AF) experienced NOAF. Patients with pre-existing AF had the largest left atrial volume index at 76.3 ± 28.6 cm3/m2 followed by NOAF at 68.1 ± 26.6 cm3/m2 and then no AF at 57.0 ± 21.7 cm3/m2 (P < 0.001). Multivariable regression identified the following risk factors in association with NOAF: left atrial volume index ≥76 cm2 (OR: 2.538 [95% CI: 1.165-5.531]; P = 0.0191), body mass index <22 kg/m2 (OR: 4.064 [95% CI: 1.500-11.008]; P = 0.0058), EATv (OR: 1.007 [95% CI: 1.000-1.014]; P = 0.043), aortic annulus area ≥659 mm2 (OR: 6.621 [95% CI: 1.849-23.708]; P = 0.004), and sinotubular junction diameter ≥35 mm (OR: 3.891 [95% CI: 1.040-14.552]; P = 0.0435). The C-statistic of the model was 0.737, compared with 0.646 in a model that excluded imaging variables. ConclusionsUnderlying cardiac structural differences derived from cardiac imaging may be useful in predicting NOAF following transfemoral TAVR, independent of other clinical risk factors.

The PIGTAIL paradigm for a fast and safe transfemoral transcatheter aortic valve replacement.

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."

Temporal trends with the Evolut family of self-expanding transcatheter heart valves: A single-center experience.

The Evolut self-expanding valve (SEV) systems (Medtronic), were designed to accommodate varying valve sizes and reduce paravalvular leak (PVL) while maintaining a low delivery profile. These systems have evolved between product generations, alongside valve deployment techniques changing over time. This study aimed to examine whether these changes impacted clinical outcomes. EPROMPT is a prospective, investigator-initiated, postmarketing registry of consecutive patients undergoing transfemoral transcatheter aortic valve replacement (TAVR) using the Evolut PRO/PRO+SEV system. A total of 300 patients were divided into three consecutive cohorts of 100 patients according to implantation date (January to October 2018, November 2018 to July 2020, and August 2020 to November 2021). Procedural and clinical outcomes over these time periods were compared. Valve Academic Research Consortium (VARC)-2 device implantation success improved over time (70.0% vs. 78.0% vs. 88.8%, p = 0.01), with a similar trend for VARC-3 device success (94.7% vs. 81.7% vs. 96.8%, p < 0.001). PVL (all degrees) frequency was likewise reduced over time (31.0% vs. 17.0% vs. 19.2%, p = 0.04). Furthermore, a trend was noticed toward shorter procedure times and shorter length of stay. However, postprocedural pacemaker implantation rates did not significantly differ (15.2% vs. 21.1% vs. 14.0%, p = 0.43). During a 3-year period, we demonstrated better TAVR outcomes with newer SEV iterations, alongside changes in implantation techniques, which might result in better procedural and clinical outcomes. However, we did not see a significant change in peri-procedural pacemaker rates for SEV.

Mitral regurgitation carries greater prognostic significance than mitral stenosis in patients undergoing transcatheter aortic valve replacement.

This study assessed the outcomes of concomitant mitral valve disease and severe aortic stenosis in patients undergoing transcatheter aortic valve replacement (TAVR). Echocardiographic data of 813 patients with severe aortic stenosis undergoing transfemoral TAVR were collected, and clinical outcomes were analyzed for individuals with mitral stenosis and mitral regurgitation. The final cohort includes 788 patients with severe calcific aortic stenosis. Among single parameters of mitral stenosis, a smaller baseline mitral valve area (MVA) by the continuity equation and higher postprocedural mean mitral gradients (MMG) were associated with an increased risk of death at 1 year (P-values 0.02 and <0.01, respectively), but no correlation with outcomes was demonstrated after multivariate adjustment for major prognosticators. Mitral stenosis (based on MVA + MMG) was not associated with complications or mortality. Mitral regurgitation was present in 94.6% of the population at baseline and regressed by at least one grade post-TAVR in 28% of the patients. The improvement in mitral regurgitation was associated with a greater prosthetic effective orifice area (P-value 0.03). Significant (at least moderate) residual mitral regurgitation was correlated with short-term complications and shown to be an independent predictor of 1-year mortality (P-value 0.02, odds ratio (OR) 5.37, confidence interval 1.34-21.5). Mitral regurgitation has a greater impact on TAVR patients than mitral stenosis as assessed by functional methods.

OR3-9 | Characteristics, Trends, and Outcomes of Intravascular Lithotripsy-Assisted Transfemoral Transcatheter Aortic Valve Replacement In the United States: A Nationwide Analysis from the Vizient Clinical Database

OR3-9 | Characteristics, Trends, and Outcomes of Intravascular Lithotripsy-Assisted Transfemoral Transcatheter Aortic Valve Replacement In the United States: A Nationwide Analysis from the Vizient Clinical Database

C-83 | Characteristics, Trends, and Outcomes of Intravascular Lithotripsy-Assisted Transfemoral Transcatheter Aortic Valve Replacement In the United States: A Nationwide Analysis from the Vizient Clinical Database

C-83 | Characteristics, Trends, and Outcomes of Intravascular Lithotripsy-Assisted Transfemoral Transcatheter Aortic Valve Replacement In the United States: A Nationwide Analysis from the Vizient Clinical Database

Collagen-Based Bailout Compared to Suture-Mediated Vascular Closure Alone During Transcatheter Aortic Valve Replacement

BackgroundHemostasis for transfemoral transcatheter aortic valve replacement (TAVR) is typically achieved using a suture-mediated vascular closure device (VCD) prior to large-bore sheath insertion (preclosure technique). Recently, the addition of a hybrid closure technique using a preclose technique with the addition of a collagen-plug VCD after sheath removal in cases of failed hemostasis has been utilized. MethodsData were collected from the Northwell TAVR registry, including 3 high-volume TAVR centers. We evaluated a preclose strategy with suture-mediated vascular closure alone (“legacy strategy”) and standard bailout techniques versus a contemporary hybrid strategy of suture-mediated closure with collagen-mediated closure bailout. The primary end point was major or minor vascular complications as defined by the VARC-3 criteria. ResultsA total of 1327 patients were included, of which 791 patients underwent TAVR with suture-mediated closure alone and 536 with contemporary strategy. The primary end point (major or minor vascular complication) was lower in the contemporary strategy (5.44% vs 1.31%; P < .001). Both minor (3.92% vs 1.12%; P = .002) and major (1.14% vs 0.19%; P = .0196) vascular complications were reduced and the total length of stay was less in the contemporary strategy (median of 3 days vs 2 days; P < .0001). Using multivariable analysis, we observed that vascular management strategy significantly improved the composite primary outcome when adjusted for sheath size, peripheral artery disease, carotid disease, and site of procedure. In the contemporary group, bailout collagen-plug VCD with an Angio-Seal (Terumo Medical) was used in 68 patients (12.69%) and bailout MANTA (Teleflex) was required in 4 patients (0.75%). There were no major or minor vascular complications among the patients who received bailout collagen-plug VCD. ConclusionsA contemporary hybrid strategy of suture-mediated closure with collagen-mediated closure bailout reduces the risk of vascular complications among patients undergoing transfemoral TAVR.

Transcarotid versus transfemoral transcatheter aortic valve replacement: A systematic review and meta-analysis

BackgroundIn the 2021 Transcatheter Valve Therapy (TVT) registry, 8.9 % of patients underwent TAVR via access sites other than the femoral artery. Transthoracic approaches may be contraindicated in some patients and may be associated with poorer outcomes. Therefore other alternative access routes are increasingly being performed. We conducted a systematic review of the literature on transcarotid transcatheter aortic valve replacement (TC-TAVR) and meta-analysis comparing outcomes of TC-TAVR and other access routes. MethodsWe comprehensively searched for controlled randomized and non-randomized studies from 4 online databases. We presented data using risk ratios (95 % confidence intervals) and measured heterogeneity using Higgins' I2. ResultsSixteen observational studies on transcarotid TAVR were included in the analysis; 4 studies compared TC-TAVR vs TF-TAVR. The mean age and STS score for patients undergoing TC-TAVR were 80 years and 7.6 respectively. For TF-TAVR patients, mean age and STS score were 81.2 years and 6.5 respectively. There was no difference between patients undergoing TC-TAVR and TF-TAVR in the following 30-day outcomes: MACE [8.4 % vs 6.7 %; OR 1.32 (95 % CI 0.71–2.46 p = 0.38) I2 = 0 %], mortality [5.6 % vs 4.0 %; OR 0.42 (95 % CI 0.60–3.37, P = 0.42) I2 = 0 %] and stroke [0.7 % vs 2.3 %; OR 0.49 (95 % CI 0.09–2.56, P = 0.40) I2 = 0 %]. There was no difference in 30-day major vascular complications [0.7 % vs 3 %; OR 0.55 (95 % CI 0.06–5.29, P = 0.61) I2 = 39 %], major bleeding [0.7 % vs 3.8 %; OR 0.39 (95 % CI 0.09–1.67, P = 0.21) I2 = 0 %], and moderate or severe aortic valve regurgitation [8.6 % vs 9.9 %; OR 0.89 (95 % CI 0.48–1.65, P = 0.72) I2 = 0 %]. ConclusionThere are no significant differences in mortality, stroke MACE and major or life-threatening bleeding or vascular complications when TC-TAVR is compared to TF-TAVR approaches.

Transfemoral transcatheter aortic valve replacement for pure aortic regurgitation

Transfemoral transcatheter aortic valve replacement for pure aortic regurgitation

Intraoperative Corticosteroids and Pacemaker Implantation After Transcatheter Aortic Valve Replacement.

Transcatheter aortic valve replacement (TAVR) has revolutionized the treatment of aortic stenosis. However, conduction disturbances leading to pacemaker implantation remain a common complication, increasing morbidity and mortality in these patients. Hence, measures to lower its incidence should be taken, and corticosteroid therapy could be effective by reducing inflammation caused by direct mechanical trauma to the conduction system. A retrospective cohort study was conducted at the Centro Hospitalar de Vila Nova de Gaia/Espinho, analyzing the medical records of patients with native severe aortic stenosis who underwent transfemoral TAVR in 2022. The Chi-square test was used to compare the rate of pacemaker implantation in patients who received corticosteroids with patients who didn't. The statistical significance was considered for a p-value <0.05. A total of 341 patients were included in this study. Monitored anesthesia care was the preferred anesthetic technique (99.1%). Sixty-three point three percent (63.3%) of patients received corticosteroids at the beginning of the procedure. Corticosteroid administration did not significantly affect the incidence of permanent pacemaker implantation (p=0.277), vascular complications on the access site (p=0.765), or in-hospital mortality (p=0.909). Male gender, 1st-degree atrioventricular block, and right branch block were the only identified predictors of permanent pacemaker implantation after transfemoral TAVR (p=0.041 <0.001 and <0.001, respectively). Corticosteroid administration at the beginning of TAVR doesn't seem to influence the incidence of permanent pacemaker implantation, which can suggest that other factors play a more important role in the development of conduction disturbances leading to pacemaker implantation.

Right transaxillary transcatheter aortic valve replacement is comparable to left despite challenges.

Transaxillary access is the most popular alternative to transfemoral transcatheter aortic valve replacement. Although left transaxillary access is generally preferred, right transaxillary transcatheter aortic valve replacement could be challenging because of the opposing axillary artery and aortic curvatures, which may warrant procedural modifications to improve alignment. Our aim is to compare our single center's outcomes for left and right transaxillary access groups and to evaluate procedural modifications for facilitating right transaxillary transcatheter aortic valve replacement. Patient characteristics and outcomes were compared for consecutive left or right axillary TAVRs performed from 6/2016 to 6/2022 with SAPIEN 3. The effects of our previously reported "flip-n-flex" technique on procedural efficiency and new conduction disturbances were subanalyzed in the right axillary group. Right and left transaxillary transcatheter aortic valve replacement were performed in 25 (18 with the "flip-n-flex" technique) and 26 patients, respectively. There were no significant differences between patient characteristics or outcomes. Right axillary subanalysis showed the "flip-n-flex" technique group had significantly shorter fluoroscopy times (21.2 ± 6.2 vs 29.6 ± 12.4min, p = 0.03) and a trend towards less permanent pacemaker implantation (6.3% vs. 42.9%, p = 0.07) compared to the group without "flip-n-flex". In our study, despite anatomical challenges, right transaxillary transcatheter aortic valve replacement is comparable to left access. The "flip-n-flex" technique advances right transaxillary as an appealing access for patients with few options.

Transfemoral transcatheter aortic valve replacement with VitaFlowTM valve for pure native aortic regurgitation in patients with high surgical risk: Rationale and design of a prospective, multicenter, and randomized SEASON-AR trial

BackgroundPrevious studies primarily demonstrated that transfemoral transcatheter aortic valve replacement (TAVR) with self-expanding valve appeared to be a safe and feasible treatment for patients with pure native aortic regurgitation (AR). However, the routine application of transfemoral TAVR for pure AR patients lacks support from randomized trials. Trial designSEASON-AR trial is a prospective, multicenter, randomized, controlled, parallel-group, open-label trial, involving at least 20 sites in China, aiming to enroll 210 patients with pure native severe AR and high surgical risk. All enrolled patients are randomly assigned in a 1:1 fashion to undergo transfemoral TAVR with VitaFlowTM valve and receive guideline-directed medical therapy (GDMT) or to receive GDMT alone. The primary endpoint is the rate of major adverse cardiac events (MACE) at 12 months after the procedure, defined by the composite of all-cause mortality, disabling stroke, and rehospitalization for heart failure. The major secondary endpoints encompass various measures, including procedure-related complications, device success, 6-minute walk distance, and the occurrence of each individual component of the primary endpoint. After hospital discharge, follow-up was conducted through clinical visits or telephone contact at 1, 6, and 12 months. The follow-up will continue annually until 5 years after the index procedure to assess the long-term outcomes. ConclusionSEASON-AR trial is the first study designed to investigate the clinical efficacy and safety of transfemoral TAVR with a self-expanding valve in patients with pure native severe AR with inoperable or high-risk, as compared to medical treatment only.

Comparison of remimazolam-based and propofol-based total intravenous anesthesia on hemodynamics during anesthesia induction in patients undergoing transcatheter aortic valve replacement: a randomized controlled trial.

This study aimed to compare the hemodynamic effects of remimazolam- and propofol-based total intravenous anesthesia in patients who underwent transcatheter aortic valve replacement. This was a single-center, single-blind, randomized controlled trial set at Nara Medical University, Kashihara, Japan. We included 36 patients aged ≥ 20years scheduled to undergo elective transfemoral transcatheter aortic valve replacement (TAVR) under general anesthesia. The participants were randomly assigned to the remimazolam and propofol groups (n = 18 each). Remimazolam- or propofol-based total intravenous anesthesia was initiated at 12mg/kg/min or 2.5mcg/mL via target-controlled infusion, respectively, along with remifentanil. After confirming the loss of consciousness, the administration rate was adjusted using electroencephalographic monitoring. The primary outcome was the rate of arterial hypotension, defined as a mean arterial pressure < 60mmHg, from anesthesia induction until the beginning of the surgical incision. The total doses of ephedrine and phenylephrine were also assessed. During anesthesia induction, the arterial hypotension rates were 11.9% and 21.6% in the remimazolam and propofol groups, respectively (P = 0.01). The total dose of ephedrine was higher in the propofol group (14.4mg) than in the remimazolam group (1.6mg) (P < 0.001); however, the total dose of phenylephrine was not significantly different between the two groups (propofol 0.31mg vs. remimazolam: 0.17mg, P = 0.10). Remimazolam-based total intravenous anesthesia resulted in a lower hypotension rate than propofol-based total intravenous anesthesia during induction in patients undergoing TAVR. Remimazolam-based total intravenous anesthesia can be used safely during anesthetic induction in patients with severe aortic stenosis.

Transfemoral TAVR with Surgical Cut-down in a Patient with Aorto Bi-iliac Bypass Graft

Transcatheter aortic valve replacement (TAVR) has become the mainstream option for patients with symptomatic severe aortic valve stenosis and is preferably performed by the transfemoral route. However, a subset of patients requires alternative access with comorbidities associated with femoral access routes, and alternative access such as transapical, transaxillary, transcarotid, subclavian, and transcaval can be considered. However, access options are further limited by the presence of severe comorbidities. This case reports TAVR performed through a transfemoral approach in a patient with previous aorto bi-iliac bypass graft surgery.

Non–Vitamin K Antagonist Versus Vitamin K Antagonist Oral Anticoagulant Agents After Transcatheter Aortic Valve Replacement

BackgroundStudies comparing long-term outcomes between non–vitamin K antagonist (VKA) oral anticoagulant agents (direct oral anticoagulant agents [DOACs]) and VKA anticoagulant agents after transcatheter aortic valve replacement (TAVR) are scarce, with conflicting results. ObjectivesThe aim of this study was to examine the periprocedural, short-term, and long-term safety and effectiveness of DOACs vs VKAs in patients undergoing TAVR via femoral access with concomitant indications for oral anticoagulation. MethodsConsecutive patients undergoing transfemoral TAVR in the prospective national SwissTAVI Registry between February 2011 and June 2021 were analyzed. Net clinical benefit (a composite of all-cause mortality, myocardial infarction, stroke, and life-threatening or major bleeding) and the primary safety endpoint (a composite of life-threatening and major bleeding) were compared between the VKA and DOAC groups at 30 days, 1 year, and 5 years after TAVR. ResultsAfter 1:1 propensity score matching, 1,454 patients were available for analysis in each group. There was no significant difference in the rate of the net clinical benefit and the safety endpoints between the groups as assessed at 30 days and 1 and 5 years post-TAVR between VKAs and DOACs. VKAs were associated with significantly higher rates of 1- year (HR: 1.28; 95% CI: 1.01-1.62) and 5-year (HR: 1.25; 95% CI: 1.11-1.40) all-cause mortality. Long-term risk for disabling stroke was significantly lower in the VKA group after excluding periprocedural events (HR: 0.64; 95% CI: 0.46-0.90). ConclusionsAt 5 years after TAVR, VKAs are associated with a higher risk for all-cause mortality, a lower risk for disabling stroke, and a similar rate of life-threatening or major bleeding compared with DOACs. (SwissTAVI Registry; NCT01368250)

Transcaval versus Supra-Aortic Vascular Accesses for Transcatheter Aortic Valve Replacement: A Systematic Review with Meta-Analysis.

A growing body of evidence suggests that extrathoracic vascular accesses for transcatheter aortic valve replacement (TAVR) yield favorable outcomes and can be considered as primary alternatives when the gold-standard transfemoral access is contraindicated. Data comparing the transcaval (TCv) to supra-aortic (SAo) approaches (transcarotid, transsubclavian, and transaxillary) for TAVR are lacking. We aimed to compare the outcomes and safety of TCv and SAo accesses for TAVR as alternatives to transfemoral TAVR. A systematic review with meta-analysis was performed by searching PubMed/MEDLINE and EMBASE databases for all articles comparing TCv-TAVR against SAo-TAVR published until September 2023. Outcomes included in-hospital or 30-day all-cause mortality (ACM) and postoperative complications. A total of three studies with 318 TCv-TAVR and 179 SAo-TAVR patients were included. No statistically significant difference was found regarding in-hospital or 30-day ACM (relative risk [RR] 1.04, 95% confidence interval [CI] 0.47-2.34, p = 0.91), major bleeding, the need for blood transfusions, major vascular complications, and acute kidney injury. TCv-TAVR was associated with a non-statistically significant lower rate of neurovascular complications (RR 0.39, 95%CI 0.14-1.09, p = 0.07). These results suggest that both approaches may be considered as first-line alternatives to transfemoral TAVR, depending on local expertise and patients' anatomy. Additional data from long-term cohort studies are needed.

Vascular Complications and Bleeding After Transfemoral TAVR With Surgical Versus Percutaneous Approach: A Contemporary Prospective Study

Background: Percutaneous (PC) access has become the first‐line strategy for transfemoral (TF) transcatheter aortic valve replacement (TAVR), but surgical cutdown (SC) may be required in selected and usually challenging cases. We aimed to compare the efficacy and safety of SC versus echo‐guided PC approach in TF TAVR.Methods: Between November 2019 and December 2020, all patients undergoing TF TAVR were included in a prospective study. The choice of PC or SC strategy was left at operators’ discretion, according to predictable access site difficulties. The primary endpoint included all vascular complications (VCs) and all bleeding at 1‐month follow‐up according to Valve Academic Research Consortium‐2 criteria.Results: Among 225 patients, 166 (73.8%) and 59 (26.2%) underwent PC or SC approach, respectively. Median age was 82 years, EuroSCORE 2 was higher (p = 0.02), and peripheral arterial disease (p &lt; 0.001) was more common in the SC group. Femoral access was successful in 100% in the SC group vs 97.6% in the PC group (p = 0.2). The primary endpoint was reached in 32 patients (14.2%), 5 (8.4%) in the SC group and 27 (16.2%) in the PC group (p = 0.1) with low incidence of major VC in both groups (1.7% vs 3% in the SC and PC groups respectively, p = 0.6).Conclusion: Despite a higher risk profile of patients in the SC group, SC and PC approaches appear safe and effective in TF TAVR, with a high success rate. SC may be considered when vascular access is anticipated as complex, but this strategy might be confirmed in a randomized study.Trial Registration: ClinicalTrials.gov identifier: NCT03865043