Transaxillary Transcatheter Aortic Valve Replacement Research Articles

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.

Transaxillary Versus Transaortic Transcatheter Aortic Valve Implantation in the Treatment of Aortic Stenosis: An Updated Systematic Review and Meta-Analysis.

Transcatheter aortic valve replacement (TAVR) is a technique that can be performed through multiple approaches, and the benefits of one approach over another are still being evaluated to make sure patients receive the best possible care. Our meta-analysis aims to compare clinical and procedural outcomes of the transaxillary (TAx) and transaortic (TAo) approaches to validate the more optimal procedure.The systematic literature search was done via PubMed/MEDLINE, Embase, and the Cochrane Central databases from inception to December 2021, to identify articles reporting data on both TAx TAVR and TAo TAVR. In addition, we checked ClinicalTrials.gov for more published or unpublished trials. Baseline patient characteristics, procedure results, and clinical results were extracted from the article and pooled for analysis. A quantitative meta-analysis was conducted using Review Manager (RevMan) version 5.3 (Nordic Cochrane Centre, The Cochrane Collaboration, Copenhagen, Denmark). The outcomes extracted included blood transfusion, conversion to sternotomy, tamponade, contrast amount, procedure time, bleeding incidents (minor, major, or life-threatening), length of stay (LOS), vascular complications (minor or major), acute kidney injury (AKI), paravalvular leak (PVL), permanent pacemaker (PPM) implantation, 30-day mortality, one-year mortality, 30-day stroke, and device success.The final analysis included 11 articles, consisting of 10 observational studies and a pivotal trial. Cumulative results revealed that the TAo approach had a significantly lower incidence of vascular complications (RR = 2.30; 95% CI = 1.22 to 4.35), and the need for implantation of a permanent pacemaker (RR = 1.82; 95% CI = 1.30 to 2.54) along with a lower amount of contrast (mean difference (MD) = 27.40; 95% CI = 3.73 to 51.08) needed to be used. The TAx group was associated with a significantly lower 30-day mortality (RR = 0.46; 95% CI = 0.31 to 0.69), AKI (RR = 0.47; 95% CI = 0.33 to 0.67), and length of hospital stay (MD = −1.95; 95% CI = −2.51 to −1.38). No significant difference was observed between the outcomes of 30-day stroke (RR = 1.38; 95% CI = 0.81 to 2.33), PVL (RR = 1.05; 95% CI = 0.50 to 2.18), tamponade (RR = 0.71; 95% CI = 0.12 to 4.03), conversion to sternotomy (RR = 0.51; 95% CI = 0.06 to 4.30), device success (RR = 0.97; 95% CI = 0.88 to 1.07), the incidence of bleeding (RR = 0.75; 95% CI = 0.51 to 1.10), and procedure time (MD = 4.44; 95% CI = −96.30 to 105.17).Both the procedures were associated with their benefits and risks. Although most of the outcomes favored TAx transcatheter aortic valve implantation (TAVI), it is too early to say if it would be better than TAo TAVI. To authenticate the findings concluded in this meta-analysis and further improve our understanding of the efficacy, safety, and risk profile between TAx and TAo approaches for TAVI, large sample randomized clinical trials are required on a wide scale.

Percutaneous versus surgical transaxillary access for transcatheter aortic valve replacement: a propensity-matched analysis of the US experience.

As transaxillary (TAx) access has become the most common alternative to transfemoral (TF) transcatheter aortic valve replacement (TAVR), there is increasing use of a percutaneous approach. This study sought to determine whether there are differences in outcomes using a percutaneous access versus cutdown for TAx TAVR. Using data from the STS/ACC TVT Registry, consecutive patients undergoing TAx TAVR with balloon-expandable valves between July 2015 and December 2020 were included. Propensity score-based matching was performed to evaluate the association between method of TAx access and outcomes. Of 4,219 patients, 1,140 (27.0%) underwent percutaneous access and 3,079 (73.0%) had surgical cutdown for TAx TAVR, with the proportion of percutaneous cases increasing over time. After propensity matching, there were no significant baseline differences between patients undergoing TAx access by either approach. At 30 days, there were similar rates of all-cause mortality (4.8% in percutaneous patients vs 4.1% in surgical patients; p=0.40) and stroke (7.7% vs 6.5%; p=0.25). Those undergoing percutaneous TAx access were more likely to receive conscious sedation and have less need for the intensive care unit (ICU). Percutaneous access was associated with a higher rate of major vascular complication (3.0% vs 1.5% in surgical patients; p=0.02) but not life-threatening bleeding (0.3% vs 0.1%; p=0.31). This study supports the safety and efficacy of percutaneous TAx TAVR compared to traditional surgical cutdown. Percutaneous access was associated with a shorter ICU stay and a higher rate of major vascular complication without an increase in life-threatening bleeding.

Simplified Trans-Axillary Aortic Valve Replacement Under Local Anesthesia – A Single-Center Early Experience

BackgroundThe axillary artery is an alternative route for patients with comorbidities and unfavorable femoral arteries who need transcatheter aortic valve replacement (TAVR). Simplified trans-axillary transcatheter aortic valve replacement (TAx-TAVR) implies a completely percutaneous approach under local anesthesia and arteriotomy closure with vascular closure techniques. Herein, we report on early experience with simplified TAx-TAVR under local anesthesia. MethodsWe enrolled all consecutive patients who underwent simplified TAx-TAVR in our center. Main study parameter was the incidence of axillary access related major vascular complications within 30 days. Secondary parameters included a composite early safety endpoint, axillary access-site related vascular/bleeding complications and short-term mortality. Post TAVR axillary stent patency was evaluated during follow-up by CT-analysis. ResultsBetween July 2018 and April 2020, Tax-TAVR was attempted in 35 patients with a mean age of 79 years. Local anesthesia and conscious sedation were used in 91.4% (n = 32) and 8.6% (n = 3) respectively. A covered stent was needed for complete axillary hemostasis in 44.1% (n = 15). Device success was achieved in 91.2% (n = 31/34). The 30-day axillary artery major vascular and ≥major bleeding complication rates were 14% (n = 5) and 11% (n = 4). The early safety endpoint was reached in 22.9% (n = 8). Mortality rates at 30 days and six months were 2.9% and 11.6%. Computed tomography (CT) confirmed axillary stent patency during follow-up in 82% (n = 9/11). ConclusionsIn patients with high/prohibitive surgical risk and unsuitable femoral access, simplified TAx-TAVR under local anesthesia offers a valuable alternative for transfemoral TAVR but requires advanced access site management techniques including covered stents. Our data suggest an unmet clinical need for dedicated TAx closure devices.

The Safety and Efficacy of a Minimalist Approach for Percutaneous Transaxillary Transcatheter Aortic Valve Replacement (TAVR)

ABSTRACT Background The safety and efficacy of percutaneous transaxillary transcatheter aortic valve replacement (TAVR) require evaluation. Transfemoral (TF) approach is the standard vascular access for TAVR, but some patients require alternative access due to iliofemoral artery disease. Transaxillary access has been shown to be as safe as TF access. There are limited reports of percutaneous transaxillary TAVR with a minimalist approach. Methods Consecutive patients undergoing percutaneous transaxillary TAVR were enrolled. Clinical and procedural characteristics and clinical outcomes were reviewed and compared to TF TAVR performed during the same period. Results Among 221 patients who underwent TAVR, 25 patients (11%) had TAVR with a percutaneous transaxillary approach based on computed tomography findings. Median age was 80 years; median STS score was 7%. STS score was higher (7% vs 4%, P = 0.008) and peripheral artery disease was more prevalent (64% vs 13%, P = 0.0001) among patients requiring transaxillary access. Twenty-four (96%) patients underwent the procedure with monitored anesthesia care with pectoral-1 nerve block. Hemostasis was achieved with preapplied ProglideTM closure devices, with an additional closure device in 5 patients (20%). Median length of stay was 3 days, longer than in the TF group (2 days). There was no death, stroke, or major vascular complication. One minor vascular complication required surgical repair. Fluoroscopy time was longer in the transaxillary group than in the TF group (20 vs 16 min, P = 0.0004). Conclusions Percutaneous transaxillary TAVR is a safe and effective alternative approach and can be performed with a minimalist approach with outcomes comparable to TF TAVR.

Safety and efficacy of transaxillary transcatheter aortic valve replacement using a current-generation balloon-expandable valve

BackgroundTransaxillary access (TAx) has shown promise as an excellent alternative TAVR option, but data on the Edwards SAPIEN 3 in TAx-TAVR is limited. We sought to study the safety and efficacy of TAx-TAVR using this current-generation balloon-expandable valve.MethodsA retrospective study of our first 24 TAx and 20 transthoracic (TT) TAVR patients treated with the SAPIEN 3 valve was performed, and the patients’ preoperative characteristics, procedural outcomes, and clinical outcomes were compared to our first 100 transfemoral (TF) patients using the SAPIEN 3 device.ResultsThere were no statistical differences observed for outcomes between the TAx and TF groups, despite the TAx patients having more comorbidities (STS-PROM 11.3 ± 7.6 versus 7.3 ± 5.2, p = 0.042). In addition, no significant difference was found in the fluoroscopy time and contrast amount between the two groups. The patients’ baseline characteristics were similar between the TAx and TT groups. Their procedural and clinical outcomes were comparable, but there was a trend towards lower incidence of acute kidney injury (13.0% versus 23.5%), new-onset atrial fibrillation (5.6% versus 33.3%), shorter median length of stay postoperatively (4 versus 6 days), fewer discharges to rehabilitation (16.7% versus 35.0%), and a lower rate of readmission within 30-days (8.3% versus 35.0%), all favoring TAx access.ConclusionsTAx-TAVR with the SAPIEN 3 valve is a safe alternative to TF access. It offers advantages of improved recovery over TT access, and appears to be a superior alternative-access option for TAVR. TAx access could be preferred when TF access is not feasible.

Direct aortic route versus transaxillary route for transcatheter aortic valve replacement: a systematic review and meta-analysis.

BackgroundThe transfemoral route is contraindicated in nearly 10% of transcatheter aortic valve replacement (TAVR) candidates because of unsuitable iliofemoral vessels. Transaxillary (TAx) and direct aortic (DAo) routes are the principal nonfemoral TAVR routes; however, few studies have compared their outcomes.MethodsWe performed a systematic review and meta-analysis to compare the rates of mortality, stroke, and other adverse events of TAx and DAo TAVR. The study was prospectively registered with PROSPERO (registration number: CRD42017069788). We searched Medline, PubMed, Embase, and Cochrane databases for studies reporting the outcomes of DAo or TAx TAVR in at least 10 patients. Studies that did not use the Valve Academic Research Consortium definitions were excluded. We included studies that did not directly compare the two approaches and then pooled rates of events from the included studies for comparison.ResultsIn total, 31 studies were included in the quantitative meta-analysis, with 2,883 and 2,172 patients in the DAo and TAx TAVR groups, respectively. Compared with TAx TAVR, DAo TAVR had a lower Society of Thoracic Surgery (STS) score, shorter fluoroscopic time, and less contrast volume use. The 30-day mortality rates were significantly higher in the DAo TAVR group (9.6%, 95% confidence interval (CI) = [8.4–10.9]) than in the TAx TAVR group (5.7%, 95% CI = [4.8–6.8]; P for heterogeneity <0.001). DAo TAVR was associated with a significantly lower risk of stroke in the overall study population (2.6% vs. 5.8%, P for heterogeneity <0.001) and in the subgroup of studies with a mean STS score of ≥8 (1.6% vs. 6.2%, P for heterogeneity = 0.005). DAo TAVR was also associated with lower risks of permanent pacemaker implantation (12.3% vs. 20.1%, P for heterogeneity = 0.009) and valve malposition (2.0% vs. 10.2%, P for heterogeneity = 0.023) than was TAx TAVR.ConclusionsDAo TAVR increased 30-day mortality rate compared with TAx TAVR; by contrast, TAx TAVR increased postoperative stroke, permanent pacemaker implantation, and valve malposition risks compared with DAo TAVR.

CRT-600.11 Percutaneous Transaxillary Transcatheter Aortic Valve Replacement (TAVR) With Minimalist Approach as Primary Alternative Access to Transfemoral Access

Transfemoral approach is the standard vascular access for TAVR, but it is not always feasible for patients with severely diseased iliofemoral arteries. Axillary approach with surgical cutdown has been shown to have similar outcomes to transfemoral approach. More recently, percutaneous transaxillary

Right Transaxillary Transcatheter Aortic Valve Replacement Using the “Flip-n-Flex” Technique

Right transaxillary transcatheter aortic valve replacement (TAx-TAVR) is rarely performed due to challenging vascular tortuosity and unfavorable implantation angles. We explored this procedure using thenewer-generation balloon-expandable SAPIEN 3 (Edwards Lifesciences, Irvine, CA) valve and our novel "flip-n-flex" technique. The safety and effectiveness of the procedure and the learning curve of our early experiences were investigated. The first 10 consecutive patients undergoing right TAx-TAVR performed at our center from June 2016 to May 2018 were included in the study. Patients' preoperative characteristics, procedural outcomes, and clinical outcomes were studied. Intraoperative fluoroscopy times were also reviewed to analyze the procedural learning curve. The 10 patients were a mean age of 81.8 ± 8.7 years, and 5 patients (50%) were women. Mean Society of Thoracic Surgeons Predicted Risk of Mortality was 12.0% ± 9.5%. Procedural success was achieved in all cases without vascular complications. Paravalvular leak was absent or mild in all patients. Two patients (20%) required permanent pacemaker implantation. The median postoperative length of stay was 4 days (range, 2-13 days). The 30-day mortality was 0%. Mean transvalvular gradient improved from 38.4 ± 12.6 mm Hg to 9 ± 4.4 mm Hg postoperatively. New York Heart Association Functional Classification improved in all patients. The fluoroscopy time showed marked reduction from 44.1 ± 8.2 minutes to 17.4 ± 2.9 minutes with the use of the flip-n-flex technique. Our early experience of right TAx-TAVR with the SAPIEN 3 valve demonstrated satisfactory outcomes and a quick learning as facilitated by the flip-n-flex technique. This could be a beneficial TAVR approach to suitable patients.

Simple "flip-n-flex" technique facilitates coaxial SAPIEN 3 valve alignment in right transaxillary transcatheter aortic valve replacement.

Simple "flip-n-flex" technique facilitates coaxial SAPIEN 3 valve alignment in right transaxillary transcatheter aortic valve replacement.

Outcomes Following Subclavian and Axillary Artery Access for Transcatheter Aortic Valve Replacement: Society of the Thoracic Surgeons/American College of Cardiology TVT Registry Report

ObjectivesThe aim of this study was to analyze the frequency and outcomes of patients who underwent transsubclavian or transaxillary (TAx) transcatheter aortic valve replacement (TAVR) using the balloon-expandable SAPIEN 3 prosthesis compared with traditional alternative access, transapical (TA) and transaortic (TAo). BackgroundThe transsubclavian and TAx approaches for TAVR are rapidly growing alternatives in the setting of hostile iliofemoral arteries, yet few data exist. MethodsThe Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry was queried for all patients undergoing TAx TAVR with the SAPIEN 3 prosthesis from June 2015 to February 2018. Secular trends over time were evaluated. Logistic regression analyses used to assess risk-adjusted outcomes. Propensity score matching was used to compare TAx access with TA and TAo access. ResultsIn total, 3,628 patients (5.7%) underwent nontransfemoral access with the SAPIEN 3. Overall, TAx TAVR accounted for 1,249 of these patients (34.4%). There has been rapid recent growth in TAx TAVR (from 20.2% in the third quarter of 2015 to 49.0% in the fourth quarter of 2017; p < 0.001 for trend) and a concomitant decrease in TA and TAo access (from 61.9% in the third quarter of 2015 to 35.3% in the fourth quarter of 2017; p < 0.001 for trend). The median number of TAx TAVR cases per hospital during the study period was 2, and 78.2% of centers performed ≤5 TAx TAVR procedures. The device success rate was 97.3%, and the major vascular complication rate was 2.5%. After propensity matching, TAx access had lower 30-day mortality (5.3% vs. 8.4%; p < 0.01), shorter lengths of intensive care unit and hospital stay, but a higher stroke rate (6.3% vs. 3.1%; p < 0.05) compared with TA and TAo access. ConclusionsTAx access has become the most frequent alternative access route for balloon-expandable TAVR procedures. Outcomes following TAx TAVR appear positive despite the relatively early experience of most centers performing these cases.