Transfemoral Transcatheter Aortic Valve Replacement Research Articles

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

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.

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 VARC3 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 multivariate 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 Angioseal (Abbott Vascular Devices) 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.

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.

Transcatheter “Sandwich” Valve-in-Valve Implantation Technique for Pure Aortic Regurgitation: Operation Skills and Early Experience

No commercial “on-label” transfemoral transcatheter aortic valve replacement (TAVR) device for aortic regurgitation (AR) is available in most countries. TAVR for AR with an “off-label” self-expanding device has shown acceptable procedural success but it elevated rates of early mortality and other complications. Valve disposition or displacement frequently occurs during transfemoral TAVR (TF-TAVR) for AR with a self-expanding valve, because of weak anchoring force. To overcome this problem, we propose a transcatheter “sandwich” valve-in-valve implantation (SVIV) technique, which has achieved good results. Our initial results and experience in a case series comprising seven patients suggest that the SVIV technique using commercially available self-expanding valves may be an option for treating selected patients with AR with high risk for surgical valve replacement. Compared with the traditional method, this technique can decrease the incidence of complications, particularly conduction block, but several technical details require the operator’s attention. Additional research is required to confirm the superiority of this technology.

Minimum-incision transsubclavian transcatheter aortic valve replacement with balloon-expandable valve for dialysis patients

BackgroundDialysis patients undergoing transcatheter aortic valve replacement (TAVR) face increased risk and have poorer outcomes than non-dialysis patients. Moreover, TAVR in dialysis patients using an alternative approach is considered extremely risky and little is known about the outcomes. We routinely perform minimum-incision transsubclavian TAVR (MITS-TAVR), which is contraindicated for transfemoral (TF) TAVR. This study aimed to evaluate the outcomes of MITS-TAVR compared with those of TF-TAVR in dialysis patients. MethodsThis single-center, observational study included 79 consecutive dialysis patients who underwent MITS-TAVR (MITS group, n = 22) or TF-TAVR (TF group, n = 57) under regional anesthesia. ResultsThe rates of peripheral artery disease (MITS vs. TF, 72.7 % vs. 26.3 %; p < 0.01), shaggy aortas (MITS vs. TF, 63.6 % vs. 5.26 %; p < 0.01), and tortuous aortas (MITS vs. TF, 13.6 % vs. 1.75 %; p = 0.031) were significantly higher in the MITS group. The 30-day mortality was 2.53 % and comparable between the two groups (MITS vs. TF, 4.54 % vs. 1.75 %; p = 0.479). In the MITS group, 14 patients had ipsilateral dialysis fistulas, and three patients had patent in situ ipsilateral internal thoracic artery grafts; however, no vascular complications were observed. Kaplan–Meier survival curves for the two groups showed no significant difference in the survival rate (at 2 years; MITS vs. TF, 77.3 % vs. 68.8 %; p = 0.840) and freedom from cardiovascular mortality (at 2 years; MITS vs. TF, 90.9 % vs. 96.5 %; p = 0.898). The multivariable Cox proportional hazard model also indicated that survival in the MITS group was not significantly different from that in the TF group (hazard ratio 1.48; 95 % confidence interval, 0.77–2.85, p = 0.244). The patency rate of ipsilateral dialysis fistula was 100 % during follow-up. ConclusionThe outcome of MITS-TAVR was comparable to that of TF-TAVR in dialysis patients, despite the higher risk of patient characteristics.

Balloon-Expandable Versus Self-Expandable Valve in Transcatheter Aortic Valve Replacement: A Nation-Wide Study

A few studies have reported comparative analysis of clinical outcomes between balloon-expandable valve (BEV) and self-expandable valve (SEV) after transcatheter aortic valve replacement (TAVR) in patients with severe aortic stenosis using newer-generation devices. However, those reports were mostly limited to short-term outcomes and Western populations. In the present study, data of patients with severe aortic stenosis who underwent TAVR between March 2016 and December 2018 were obtained from the National Health Insurance Service in Korea. The primary end point, defined as all-cause mortality, was compared in BEV (SAPIEN 3, Edwards Lifesciences, Irvine, California) and SEV (Evolut R, Medtronic, Minneapolis, MN) groups using a propensity-score matching analysis. Cumulative event rates of ischemic stroke, repeat procedures, and permanent pacemaker insertion (PPI) were evaluated as secondary outcomes. All events were followed up to a maximum of 3 years. A total of 1,172 patients underwent transfemoral TAVR, of whom 707 (60.3%) were treated with BEV and 452 (38.6%) with SEV. After 1:1 propensity-score matching, the BEV group showed lower all-cause mortality after a median follow-up of 12.0 months (mean: 13.1 ± 9.3 months) based on Cox proportional hazard model analysis (hazard ratio [HR] 0.67, 95% confidence interval [CI] 0.45 to 0.99, p=0.04). Cumulative incidence of ischemic stroke was not statistically different between the 2 groups (HR 0.68, 95% CI 0.29 to 1.59, p=0.37). PPI occurred less frequently in the BEV group (HR 0.4, 95% CI 0.25 to 0.64, p < 0.01). Repeat procedures were rare (1 patient in BEV and 2 patients in SEV group). In conclusion, Korean nation-wide data analysis showed that BEV was associated with less all-cause death and incidence of PPI after TAVR than was SEV using a newer-generation device.

Daily Physical Activity Measured by Wearable Smartwatch for Patients Undergoing Transcatheter Aortic Valve Replacement: Insights From the SMART TAVR Study.

This study aims to evaluate limited data about daily physical activity patterns, influential factors, and their association with 1-year mortality or rehospitalization after transcatheter aortic valve replacement (TAVR) through smartwatches. Consecutive severe aortic stenosis patients undergoing elective transfemoral TAVR in a Chinese tertiary hospital were enrolled from July 2021 to May 2022 and received a Huawei smartwatch at least 1 day before TAVR. The primary outcome was a composite of all-cause mortality or hospital readmission within 1 year. Linear mixed-effects models were applied to determine influential factors of daily step counts, and Cox proportional hazard regression models were to estimate the association between baseline step counts within 1 month since discharge and composite outcome from months 2 to 12. The dose-response association was assessed using restricted cubic spline curves. A total of 222 participants and 59 469 valid monitoring person-day records were included (mean age, 72.7 years; 61% women). Step counts increased rapidly within the first 2 months (P<0.001), followed by a slower increase for those without composite outcomes (P=0.029) and a gradual decrease for those who developed composite outcomes (P<0.001). In multivariate linear mixed models, a 1-m increase in baseline 6-minute walk test and a 1-month delay after discharge were associated with 4 (95% CI, 1-7) and 170 (95% CI, 145-194) additional step counts, respectively. In restricted cubic spline analysis, the hazard ratio declined progressively until ≈5000 steps per day, after which they leveled. Below 5000 steps, the adjusted hazard ratio of composite outcome associated with each 1000-step count increase was 0.67 (0.50-0.89; P=0.007). However, above 5000 steps, step counts were not significantly associated with the composite outcome (P=0.645), with a hazard ratio of 1.12 (0.70-1.79). Daily step counts rapidly increased within the first 2 months post-TAVR. Increased physical activity was associated with a lower risk of 1-year mortality or rehospitalization after TAVR for patients with daily step counts below 5000. URL: https://www.clinicaltrials.gov; Unique identifier: NCT04454177.

Femoral vessel complications after transfemoral TAVR-A contemporary sonography-based assessment of 480 patients with third-generation transcatheter valves.

Postinterventional sonographic assessment of the femoral artery after transfemoral transcatheter aortic valve replacement (TF-TAVR) has the potential to identify several pathologies. We investigated the incidence and risk factors of femoral vessel complications in a modern TAVR collective using postinterventional sonography. Between September 2017 and March 2022, 480 patients underwent TF-TAVR with postinterventional femoral sonography at a single center. Clinical outcomes and adverse events were analyzed after the Valve Academic Research Consortium 3 (VARC-3) criteria. In this cohort (51.2% male; age 80 ± 7.5 years, median EuroSCORE II 3.7) 74.8% (n = 359) were implanted with a self-expandable and 25.2% (n = 121) with a balloon-expandable valve. The main access (valve-delivery) was located right in 91.4% (n = 438), and the primary closure system was Proglide in 95% (n = 456). Vascular complications (VC) were observed in 29.16% (n = 140) of patients; 23.3% (n = 112) presented with minor- and 5.8% (n = 28) with major VC. Postinterventional femoral artery stenosis on the main access was observed in 9.8% (n = 47). Multivariable logistic regression analysis revealed female sex (p = .03, odds ratio [OR] 2.32, 95% confidence interval [CI] 1.09-4.89) and the number of used endovascular closure devices (p = .014, OR 0.11, 95%CI 0.02-0.64) as predictive factors for femoral artery stenosis. The incidence of postinterventional femoral artery stenosis following TF-TAVR was higher than expected with a number of used closure devices and female sex being independent risk factors. Considering the continuous advance of TAVR in low-risk patients with preserved physical activity, emphasis should be directed at the correct diagnosis and follow-up of these complications.

Transcatheter aortic valve replacement in patients with preoperative ascending aortic diameter ≥45 mm.

Current indication for concomitant replacement of ascending aorta (AA) in patients undergoing surgical aortic valve replacement is that AA diameter exceeds 45 mm. However, the impact of AA dilation (≥45 mm) in patients undergoing transcatheter aortic valve replacement (TAVR) remains unclear. We retrospectively evaluated 467 consecutive patients who underwent transfemoral TAVR from January 2016 to April 2021. Cox proportional hazards regression was performed to identify risk factors for all-cause mortality. The primary endpoint was the all-cause mortality, and the secondary endpoints were the occurrence of the aortic dissection and/or rupture. One hundred patients (21.4%) presented preoperative AA ≥45 mm. The median age was 73 years for patients with AA ≥45 mm and 75 years for patients with AA <45 mm (P=0.021). The in-hospital mortality rate was 1.1%. There was no iatrogenic injury to the AA. Only one patient (0.2%) in AA <45 mm group experienced retrograde type B aortic dissection in the descending aorta. The median follow-up was 19 [16-34] months in patients with AA ≥45 mm and 27 [15-37] months in patients with AA <45 mm (P=0.152). No statistical difference was found between the two groups regarding the overall survival (92.5%±3.5% vs. 78.3%±6.8%, P=0.198). Only one patient in AA <45 mm group experienced type A aortic dissection 10 months after the procedure. In both univariable and multivariable analysis, AA ≥45 mm was not an independent predictor for all-cause mortality. Transfemoral TAVR can be performed safely in patients with preoperative AA ≥45 mm with a low intraprocedural risk. The mid-term survival appears not to be affected by the presence of AA ≥45 mm, and adverse aortic events are rare.

Comparison of ultrasound- versus fluoroscopy-guidEd femorAl access In tranS-catheter aortic valve replacement In the Era of contempoRary devices: The EASIER registry

BackgroundVascular complications (VCs) still represent one of the principal concerns of trans-femoral trans-catheter aortic valve replacement (TF-TAVR). New-generation devices can minimize such complications but the arterial access management is left to the operator's choice. This study aims to describe the rate of VCs in a contemporary cohort of patients undergoing TAVR with new-generation devices and to determine whether an ultrasound-guided (USG) vs. a fluoroscopy-guided (FG) femoral access management has an impact on their prevention. MethodsThis is a prospective, observational, multicenter study. Consecutive patients undergoing TAVR with new-generation devices were analyzed from January 2022 to October 2022 in five tertiary care centers. Femoral accesses were managed according to the operator's preferences. All the patients underwent a pre-discharge peripheral ultrasound control. VCs and bleedings were the main endpoints of interest. ResultsA total of 458 consecutive patients were enrolled (274 in the USG group and 184 in the FG group). VCs occurred in 6.5 % of the patients (5.2 % minor and 1.3 % major). There was no difference between the USG and the FG groups in terms of any VCs (7.3 % vs. 5.4 %; p = 0.4), or any VARC-3 bleedings (6.9 % vs 6 %, p = 0.9). At logistic regression analysis, the two guidance strategies did not result as predictors of VCs (odds Ratio 0.8, 95 % Confidence Interval 0.46–1.4; P = 0.4). ConclusionsIn a contemporary cohort of patients undergoing TAVR with new-generation devices, the occurrence of VCs is low and mostly represented by minor VCs. USG and FG modalities did not affect the rate of VCs.

Bleeding in Patients Undergoing Transfemoral Transcatheter Aortic Valve Replacement: Incidence, Trends, Clinical Outcomes, and Predictors

BackgroundBleeding is one of the most frequent complications in patients undergoing transcatheter aortic valve replacement (TAVR). Importantly, major bleeding is associated with poor clinical outcomes after TAVR. However, large studies on bleeding complications in the contemporary TAVR population are limited. ObjectivesThe aim of this study was to assess the incidence, temporal trends, clinical outcomes, and predictors of bleeding in patients undergoing transfemoral TAVR. MethodsThe CENTER2 study is a pooled patient-level database from 10 clinical studies including patients who underwent TAVR between 2007 and 2022. ResultsA total of 23,562 patients underwent transfemoral TAVR. The mean age was 81.5 ± 6.7 years, and 56% were women. Major bleeding within the first 30 days was observed in 1,545 patients (6.6%). Minor bleeding was reported in 1,143 patients (4.7%). Rates of major bleeding decreased from 11.5% in 2007-2010 to 5.5% in 2019-2022 (Ptrend < 0.001). Dual antiplatelet therapy was associated with higher major bleeding rates compared with single antiplatelet therapy (12.2% vs 9.1%; OR: 1.40; 95% CI: 1.13-1.72; P = 0.002). Patients with major bleeding had increased mortality risk during the first 30 days (14.1% vs 4.3%; OR: 3.66; 95% CI: 3.11-4.31; P < 0.001) and during 1-year follow-up (27.8% vs 14.5%; HR: 1.50; 95% CI: 1.41-1.59; P < 0.001). Minor bleeding did not affect 1-year mortality risk (16.7% vs 14.5%; HR: 1.11; 95% CI: 0.93-1.32; P = 0.27). Predictors of major bleeding were female sex and peripheral vascular disease. ConclusionsBleeding complications remain frequent and important in patients undergoing transfemoral TAVR. Increased mortality risk in major bleeding persists after the initial 30 days. (Cerebrovascular Events in Patients Undergoing Transcatheter Aortic Valve Implantation With Balloon-Expandable Valves Versus Self-Expandable Valves [CENTER]; NCT03588247)