Transaxillary Transcatheter Aortic Valve Implantation Research Articles

Comparison of left ventricular with right ventricular rapid pacing on tamponade during TAVI

BackgroundSmall studies have suggested left ventricular (LV) rapid pacing has similar safety and efficacy to conventional right ventricular (RV) rapid pacing in transcatheter aortic valve implantation (TAVI). However, there are limited data on the comparative rates of tamponade.The study compared the rate of cardiac tamponade between LV and RV-pacing during TAVI. MethodsBetween 2008 and 2021, 1226 consecutive patients undergoing transfemoral or transaxillary TAVI were included. 470(38.3%) patients had TAVI deployment with RV-pacing and 756(61.7%) with LV-pacing. The primary outcome was the frequency and cause of cardiac tamponade. Secondary outcomes included efficacy, procedure duration and crossover rates. ResultsThere was a trend to less tamponade with LV-pacing, which did not reach statistical significance [11(2.3%) vs 11(1.5%);P = 0.27]. There was no significant difference in the frequency of tamponade due to annular tear [4(0.9%) vs 9(1.2%);P = 0.59] or LV free-wall perforation [1(0.2%) vs 2(0.3%);P = 0.86]. The frequency of tamponade due to RV perforation was significantly lower in the LV-pacing group [0 vs 6(2.3%);P < 0.005)]. Two patients with tamponade due to RV perforation required emergency sternotomy of whom one died. Deployment success was similar (99% vs 99.6%;P=NS). Procedure duration was shorter with LV-pacing (70 vs 80 mins;P < 0.005). Crossover to RV-pacing was low (0.9%). There were no embolizations caused by loss-of-capture in either group. ConclusionsLV-pacing appears equally efficacious and is associated with a lower risk of tamponade due to RV perforation caused by the temporary pacing wire. LV-pacing was not associated with an increased risk of tamponade due to LV free-wall perforation.

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.

Transcatheter aortic valve implantation via the left axillary artery route in a patient with a permanent pacemaker: The first transaxillary artery route experience with a Meril's MyvalTM transaortic valve in Turkey.

In light of because of its improved procedural and clinical success, transcatheter aortic valve implantation (TAVI) has become a significant alternative treatment option to surgery in patients with severe aortic valve stenosis. However, TAVI has its own contraindications and limitations, such as access route problems with transfemoral (TF) access being the safest and most widely used route. However, in patients in whom this route is unsuitable, axillary artery is the preferred alternative access route. Although TAVI valves are not licensed for axillary artery access, off-label use of balloon-expandable (Edwards Lifesciences, Irvine, CA, USA) and self-expandable (Evolute/CoreValve systems, Medtronic, Dublin, Ireland, as well as the Lotus valve system Boston Scientific Inc., Marlborough, MA, USA) valves have been reported. The Meril’s Myval™ transaortic valve is a new-generation transaortic balloon-expandable valve, and transaxillary TAVI with this valve has not been reported previously. Here, we report our experience with a Meril’s Myval™ valve in a patient with severe aortic stenosis, peripheral artery disease, and a permanently implanted pacemaker.

Percutaneous access and closure using the MANTA vascular closure device in transaxillary transcatheter aortic valve implantation.

Percutaneous access and closure using the MANTA vascular closure device in transaxillary transcatheter aortic valve implantation.

Transaxillary transcatheter aortic valve implantation utilizing a novel vascular closure device with resorbable collagen material: a feasibility study.

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. 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. Puncture location depth was variable (3.5-7.5cm). 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. 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.

Plug-based closure in completely percutaneous right-sided transaxillary transcatheter aortic valve implantation.

Plug-based closure in completely percutaneous right-sided transaxillary transcatheter aortic valve implantation.

Safety and efficacy of the percutaneous transaxillary access for transcatheter aortic valve implantation using various transcatheter heart valves in 100 consecutive patients

ObjectivesTranscatheter Aortic Valve Implantation (TAVI) can be performed via the transaxillary approach, but data about complications and procedural outcome is limited. IntroductionTAVI is an established treatment option for patients at high risk for conventional aortic valve replacement. Nowadays, the transfemoral approach is the most commonly used access for TAVI. Nevertheless, the transfemoral access is not suitable in many patients necessitating alternative approaches. MethodsWe analyzed the outcome of 100 consecutive cases receiving percutaneous transaxillary TAVI at two different hospitals. Data were retrospectively analyzed by means of procedural, hemodynamic and clinical outcome. In addition, 1st versus 2nd generation devices were analyzed. ResultsMean age was 78.2±2.1years and the logEuroSCORE I was 24.6±13.9%. Transaxillary TAVI was performed in 85% via the left and in 15% via the right axillary artery. Device success was achieved in 95%. In general, there was a clear learning curve with this approach. No patient experienced a major and 11% a minor access site complication. There was one procedural death (annular rupture) and one peri-procedural TIA. 23% of the patients received a new pacemaker. At discharge, effective orifice area was 1.94±0.16cm2 and the mean aortic gradient was 6.8±2.1mmHg. Moderate aortic regurgitation/paravalvular leakage was documented in two patients. Mortality rates at 30days and one year were 6% and 14.8%. Last but not least, 2nd generation devices showed improved procedural outcomes. ConclusionsThe percutaneous transaxillary access for TAVI is technically feasible and safe thereby yielding excellent clinical results. Condensed abstractWe investigated In 100 consecutive patients undergoing percutaneous transaxillary transcatheter aortic valve implantation thereby demonstrating that this approach is technically feasible and safe with acceptable numbers of minor vascular complications.

Early and mid-term outcomes of 1904 patients undergoing transcatheter balloon-expandable valve implantation in Italy: results from the Italian Transcatheter Balloon-Expandable Valve Implantation Registry (ITER).

The aim of this multicentre study is to report the clinical experiences of all patients undergoing transcatheter aortic valve implantation (TAVI) with a balloon-expandable device in Italy. The Italian Transcatheter balloon-Expandable valve Registry (ITER) is a real-world registry that includes patients who have undergone TAVI with the Sapien (Edwards Lifesciences, Irvine, CA, USA) bioprosthesis in Italy since it became available in clinical practice. From 2007 to 2012, 1904 patients were enrolled to undergo TAVI in 33 Italian centres. Outcomes were classified according to the updated Valve Academic Research Consortium (VARC-2) definitions. A multivariable analysis was performed to identify independent predictors of all-cause mortality. Mean age was 81.7 (SD:6.2) years, and 1147 (60.2%) patients were female. Mean Logistic EuroSCORE was 21.1% (SD:13.7). Transfemoral, transapical, transaortic and transaxillary TAVI was performed in 1252 (65.8%), 630 (33.1%), 18 (0.9%) and 4 (0.2%) patients, respectively. Operative mortality was 7.2% (137 patients). The VARC-2 outcomes were as follows: device success, 88.1%; disabling stroke, 1.0%; life-threatening and major bleeding 9.8 and 10.5%, respectively; major vascular complication, 9.7%; acute kidney injury, 8.2%; acute myocardial infarction ≤72 h, 1.5%. Perioperative pacemaker implantation was necessary in 116 (6.1%) patients. At discharge, the mean transprosthetic gradient was 10.7 (SD:4.5) mmHg. Incidence of postoperative mild, moderate or severe paravalvular leak was, respectively, 32.1, 5.0 and 0.4%. A total of 444/1767 (25.1%) deaths after hospital discharge were reported: of these, 168 (37.8%) were classified as cardiac death. Preoperative independent predictors of all-cause mortality were male gender (HR: 1.395; 95% CI:1.052-1.849); overweight, BMI 25-30 kg/m2 (HR: 0.775; 95% CI: 0.616-0.974); serum creatinine level (every 1 mg/dl increase; HR: 1.314; 95% CI:1.167-1.480); haemoglobin level (every 1 g/dl increase; HR: 0.905; 95% CI:0.833-0.984); critical preoperative state (HR: 2.282; 95% CI: 1.384-3.761); neurological dysfunction (HR: 1.552; 95% CI:1.060-2.272); atrial fibrillation (HR: 1.556; 95% CI:1.213-1.995); pacemaker rhythm (HR: 1.948; 95% CI:1.310-2.896); NYHA Class III or IV (HR: 1.800; 95% CI:1.205-2.689 or HR: 2.331; 95% CI:1.392-3.903, respectively). TAVI with a balloon-expandable device in the 'real world' shows good mid-term outcomes in terms of survival, technical success, valve-related adverse events and haemodynamic performance.

Preferential short cut or alternative route: the transaxillary access for transcatheter aortic valve implantation.

Transcatheter aortic valve implantation (TAVI) has gained widespread acceptance as a treatment option for patients at high risk for conventional aortic valve replacement. The most commonly used access site for TAVI is the common femoral artery. Yet, in a significant number of patients the transfemoral access is not suitable due to peripheral vascular disease of the lower extremity. In these cases the transaxillary approach can serve as an alternative implantation route. By considering the anatomical requirements and providing an adequate endovascular "safety-net" during the procedure the transaxillary TAVI approach results in excellent procedural and clinical outcome. However, whether the transaxillary access for TAVI is superior to other non-transfemoral approaches (e.g., transapical or direct aortic) needs to be studied in the future in a prospective randomized trial.

Transcatheter Aortic Valve Implantation by the Left Axillary Approach: A Single-Center Experience

Transcatheter aortic valve implantation (TAVI) is an accepted alternative treatment for severe symptomatic aortic stenosis in high-risk and inoperable patients. Femoral or transapical accesses are commonly used. We report our initial clinical experience with TAVI using the left-axillary artery approach. A single-center, retrospective study of patients undergoing transaxillary TAVI between January 2010 and December 2012 was performed. Procedural success was defined as successful device implantation with reduction in the mean aortic gradient and without need for conversion to open-heart surgery. Short-term echocardiographic follow-up was obtained in all patients. A total of 18 consecutive patients with severe aortic stenosis who were not candidates for surgical replacement underwent transaxillary TAVI. Mean age was 81.1±7.3 years and 14 patients (78%) were male. Median logistic European System for Cardiac Operative Risk Evaluation was 8.5% (range, 1.5% to 54.1%). Procedural success was obtained in 17 out of 18 patients (94%). There was no in-hospital or 30-day mortality. One major bleeding complication in the form of an upper gastrointestinal bleeding was observed. No stroke or major vascular complication was reported. Postoperative implantation of a permanent pacemaker was performed in 7 patients (39%). At a mean follow-up of 326±213 days, mean aortic gradient was 10.8±4.8 mm Hg. Mean aortic valve area was 1.7±0.4 cm2 and aortic insufficiency grade was mild or less in all but 1 patient, who showed moderate regurgitation. The transaxillary approach for TAVI is associated with high procedural success and low rates of stroke, vascular, or bleeding complications. This approach is an appealing alternative to the commonly used transfemoral and transapical TAVI.

Left Atrial Diameter, Aortic Mean Gradient, and Hemoglobin for Risk Stratification in Patients Undergoing Transcatheter Aortic Valve Implantation

Transcatheter aortic valve implantation (TAVI) is an alternative treatment of severe symptomatic aortic stenosis (AS) in patients with high operative risk. In spite of favorable entire results, long-term mortality of patients is high. The present study aims to identify independent preprocedural risk factors to improve risk stratification in these highly selected patients. This prospective study included 202 consecutive patients with severe symptomatic AS and high operative risk (mean logistic European System for Cardiac Operative Risk Evaluation, 22±17%; mean age, 79±6 years; 107 female). Preprocedural comprehensive examinations were performed (laboratory, electrocardiography, echocardiography, cardiac catheterization). All patients received transfemoral or transaxillary TAVI with a CoreValve prosthesis (Medtronic, Minneapolis, MN). During a follow-up of 535±333 days, 56 patients (28%) reached the primary study end point (all-cause mortality). Independent predictors of long-term mortality were as follows: hemoglobin<12.5 g/dL (hazard risk [HR], 3.62; 95% confidence interval [CI], 2.025-6.468; P<0.001), aortic mean gradient≤41 mm Hg (HR, 2.16; 95% CI, 1.272-3.655; P=0.004), and left atrial diameter>42 mm (HR, 3.09; 95% CI, 1.588-6.019; P=0.001). Our risk-stratification model based on these independent predictors separated patients into 4 groups with high (74%), intermediate (37%), low (18%), and very low (3%) all-cause mortality. In patients undergoing TAVI, preprocedural assessment of hemoglobin, aortic mean gradient, and left atrial diameter provides independent prognostic information and therefore contributes to improved risk stratification in TAVI.

Direct Percutaneous Access Technique for Transaxillary Transcatheter Aortic Valve Implantation: “The Hamburg Sankt Georg Approach”

This study questioned whether transaxillary transcatheter aortic valve implantation (TAVI) is feasible as a true percutaneous approach using percutaneous closure devices. Transaxillary TAVI is gaining increasing acceptance as an alternative to the transfemoral route; however, the access has always been done via surgical cutdown so far. Between August 2010 and September 2011, a total of 24 high-risk patients with severe aortic valvular stenosis underwent a percutaneous TAVI procedure by direct puncture of the axillary artery without surgical cutdown. For safety reasons and as a target for the puncture, a wire was advanced via the ipsilateral brachial artery. Moreover, a balloon was placed into the subclavian artery via the femoral artery for temporary vessel blockade before percutaneous vessel closure. Vascular closure was performed using either the ProStar XL system (Abbott Vascular Devices, Redwood City, California) or 2 ProGlide systems (Abbott Vascular Devices). The true percutaneous approach was successfully completed in all patients (14 left and 8 right axillary artery cases). Overall mortality at 30 days was 8.3%. Acute vascular closure device success was achieved in 17 patients (71%). Vascular closure device success rate was 100% for the ProGlide device and 37% for the ProStar device, respectively. Seven patients (29%) with failing closure devices were treated by endovascular stent graft implantation without the need for surgical repair. For the last 12 treated patients, direct closure was achieved in 11 patients. Direct puncture of the axillary artery for TAVI is feasible and safe if a wire is placed into the subclavian artery via the ipsilateral brachial artery.

Transaxillary Approach Short- and Mid-Term Results in a Single-Center Experience

Transcatheter aortic valve implantation (TAVI) is increasingly accepted as an alternative procedure in patients with severe, symptomatic aortic stenosis and high risk for surgical aortic valve replacement. Transfemoral (TF) approach is the first option when feasible, but in case of peripheral vascular disease this approach is precluded. In our institution, for this kind of patients we considered transaxillary (TAx) approach as second choice and transapical (TAp) or transaortic (TAa) as last routes. This study describes short- and mid-term morbidity and mortality for TAx approach. From November 2007 to March 2011, 284 patients underwent TAVI at our site; 229 treated by TF approach, 22 TAp, 2 TAa, and 31 TAx. Four patients were treated with an Edwards Sapien valve (Edwards Lifesciences, Inc., Irvine, CA USA) with TAx approach and 27 with CoreValve Revalving System (Medtronic Inc., Minneapolis, MN USA). TAx TAVI was performed in cath-laboratory with local anesthesia and mild sedation by a multispeciality valve team. We analyzed major adverse cardiac and cerebrovascular events, major adverse valve-related events, vascular complications, and 30 days and 6 months mortality. The procedural success rate (successful implantation of the device without intraprocedural mortality or need to conversion to open heart surgery) was 96.8% (30/31). Major adverse valve-related events were 12.9% (4/31). 30-day mortality was 6.4% (2/31) and actuarial survival at 6 months was 82.95% ± 7.96%. In one patient, procedure was converted to a TF CoreValve in emergency for hemodynamic instability after valvuloplasty due to severe difficulty to introduce the Edwards valve in the subclavian artery. TAx approach is a feasible and technically simple procedure with encouraging results considering morbidity and mortality at short- and mid-term follow-up. TAx is a valid solution in patients with contraindications to TF approach and it is an alternative approach potentially less invasive than TAp or TAa.

Anesthetic Management of Transcatheter Aortic Valve Implantation With Transaxillary Approach

To describe the anesthetic management of transcatheter aortic valve implantation (TAVI) with the transaxillary approach. An observational cohort study. Two university hospitals. Twenty-two patients with severe aortic stenosis (± regurgitation) at high risk for surgical valve replacement, with contraindications for transfemoral TAVI (81 ± 4.9 years; logistic EuroSCORE, 27% ± 16.9%). General anesthesia or local anesthesia plus sedation followed by postoperative care. Local anesthesia plus sedation and general anesthesia were used in 14 and 8 patients, respectively. Two patients undergoing local anesthesia were monitored with transesophageal echocardiography and supported with noninvasive mask ventilation during the procedure. Main complications included hemodynamic instability requiring inotropes (2 patients), severe postimplant aortic regurgitation requiring immediate second valve-in-valve implantation (1 patient), valve embolization requiring open-valve surgery (1 patient), subclavian artery dissection compromising the flow to a mammary artery graft (1 patient), ascending aortic dissection (1 patient), stroke (2 patients), and atrioventricular block requiring pacemaker implantation (3 patients). Four patients experienced an increased (baseline value × 1.5) postoperative serum creatinine. Five patients required red blood cell tranfusions (2 units). Intensive care unit stay and hospital stay were 6 (4-23) hours and 8 (8-9) days, respectively. All patients were alive 30 days after the procedure. The 6-month mortality was 9%. Transaxillary TAVI is feasible in high-risk patients with aortic stenosis and peripheral vasculopathy. Nevertheless, severe procedural complications are possible, and anesthesiologists should be prepared to assist in the management of these conditions.