Received: 22 August 2020 Revised: 25 October 2020 Accepted: 29 November 2020 DOI: 10.1002/ccd.29423 ORIGINAL STUDIES Transaxillary transcatheter ACURATE neo aortic valve implantation – The TRANSAX multicenter study Ignacio J. Amat-Santos MD PhD1 | Sandra Santos-Martínez MD1 | Lenard Conradi MD2 | Maurizio Taramasso MD PhD3 | Arnaldo Poli MD4 | Rafael Romaguera MD5 | Manuel Pan MD PhD6 | Rodrigo Bagur MD7 | Raquel del Valle MD8 | Luis Nombela-Franco MD PhD9 | Olivier D. Bhadra MD2 |  | Alfredo Redondo MD1 | Hipólito Gutiérrez MD1 | Alvaro Aparisi MD1 Itziar Gómez MsC1 | J. Alberto San Roman MD PhD1 1 CIBERCV, Hospital Clínico Universitario, Valladolid, Spain 2 Department of Cardiovascular Surgery, Universitäres Herz und Gefäßzentrum, Hamburg, Germany 3 Department of Cardiovascular Surgery, UniversitätsSpital, Zürich, Switzerland 4 Interventional Cardiology Department, ASST Ovest Milanese- Ospedale di Legnano, Milan, Italy 5 Cardiology Department, Hospital Universitari Bellvitge, Barcelona, Spain 6 Cardiology Department, Hospital Universitario Reina Sofía, Córdoba, Spain 7 Cardiology Division, London Health Sciences Centre, Department of Medicine, Western University, London, Ontario, Canada 8 Cardiology Department, Hospital Universitario Central de Asturias, Oviedo, Spain 9 Cardiology Department, Hospital Clínico Universitario San Carlos, Madrid, Spain Correspondence Ignacio J. Amat-Santos, MD, PhD, FESC, Instituto de Ciencias del Corazón (ICICOR), Hospital Clínico Universitario de Valladolid, Ramón y Cajal 3. 47005. Valladolid, Spain. Email: ijamat@gmail.com Abstract Background: Transcatheter aortic valve replacement (TAVR) via transaxillary (TAx) approach with ACURATE neo valve is an off-label procedure. Our aim was to gather information on ACURATE neo cases implanted via TAx approach and report major outcomes. Methods and Results: The TRANSAX Study (NCT04274751) retrospectively gathered patients from nine centres in Europe and North America treated with ACURATE neo valve through TAx approach up to May/2019. Follow up was pre-specified at 1-year and was obtained for all patients. A total of 75 patients (79 ± 10 years; 32% women) were included. Left axillary (72%) and conscious sedation (95.2%) were the most common setting. Risk scores were higher when right axillary artery and surgical cut-down were selected. Severe complications including valve embolization, coronary obstruction, annulus rupture, and procedural mortality did not occur. Cardiac tamponade occurred in two cases (2.7%) with one requiring conversion to open surgery (1.3%). Bail-out stenting and surgical vascular repair were required in 7 (9.3%) and 3 (4%) cases, respectively. The need for new permanent pacemaker was 8%. Procedural success (96%), in-hospital (2.7%), and 1-year mortality (8%) were comparable in all settings. Only one case (1.3%) complicated with cerebrovascular event and one (1.3%) presented moderate aortic regurgitation before discharge. Conclusions: TAx TAVR procedures with the ACURATE neo valve were presented high success rate and low in-hospital and 1-year mortality. KEYWORDS ACURATE neo, TAVI, TAVR, transaxillary, trans-subclavian Abbreviations: AS, aortic stenosis; CT, computed tomography; EuroSCORE, European system for cardiac operative risk evaluation; TAVR, transcatheter aortic valve replacement; TF, transfemoral; TAx, transaxillary; VARC-2, Valve Academic Research Consortium - 2. Catheter Cardiovasc Interv. 2020;1–8. wileyonlinelibrary.com/journal/ccd © 2020 Wiley Periodicals LLC. 1 2 1 AMAT-SANTOS ET AL. I N T RO DU CT I O N | CLINICAL PERSPECTIVES What is known? Aortic stenosis (AS) is the most frequently treated heart valve disease in our society.1 Transcatheter aortic valve replacement (TAVR) was originally The current results of ACURATE neo valve through trans- described through an antegrade transeptal route by Cribier and colleagues axillary (TAx) approach are unknown. in 2002.2 Because of the complexity of the procedure and risks of damaging the mitral apparatus, this approach was abandoned in favor of less What is new? challenging alternatives, with transfemoral (TF) route as primary option. Nevertheless, the TF approach is not feasible or carries a high risk in TRANSAX Study (NCT04274751) retrospectively gathered between 15% and 35% of the patients3 and vascular complications have 75 patients (79 ± 10 years; 32% women) from nine centres been shown to be an independent predictor of death warranting alterna- in Europe and North America demonstrating that the proce- tive access techniques for TAVR.4 In this regard, the transapical, direct dure was feasible and safe with low rate of complications aortic, transcarotid, transcaval, and transubclavian/transaxillary (TAx)5 and mortality. have been explored. Recent series suggest that TAx approach may provide better outcomes than alternative routes when TF is inadequate6,7 What is next? and even present lower rate of vascular complications than TF.4,7-9 A prospective study to confirm the outcomes of the The ACURATE neo (Boston Scientific) is a second generation self- ACURATE neo valve through TAx approach will be required. expanding transcatheter aortic bioprosthesis. The SAVI TF registry demonstrated a residual mean gradient of 8.4 ± 4.0 mmHg, 4.1% of more than mild paravalvular leak, and less than 10% need for permanent pacemaker implantation at 1-year follow up.10,11 Currently, the valve is available for transapical (ACURATE TA™) and TF (ACURATE 12 neo™) routes with large experience in challenging scenarios, 2.2 | ACURATE neo valve includ- ing the off-label TAx implantation. The ACURATE neo (Boston Scientific) is composed of porcine pericar- The TRANSAX Study (NCT04274751) aims to gather information dial leaflets sewn into a self-expanding nitinol stent covered on the of ACUARATE neo® cases worldwide implanted through TAx inside and outside with a porcine pericardial skirt. The device has a approach and report the global outcomes. supra-annular design with three stabilization arches for axial alignment, an upper-crown which guarantees stable positioning and supra-annular anchoring of the valve capping the native leaflets and mitigating the risk 2 METHODS | of coronary obstruction and para-valvular leak. Currently is the third TAVR device in terms of number of implants per year worldwide with 2.1 | Study population more than 30,000 cases performed until January 2020. TAx implantation was performed as decided by each heart team. Patients from nine centres in Europe and North America treated with Fully-percutaneous procedures were performed as described else- ACURATE neo valve through TAx approach were retrospectively col- where7 and is briefly summarized in Figure 1. Surgical cut-down was lected in a dedicated database. It was specified to all the institutions the performed as also reported previously.4 Left axillary approach was that this was an all-comers registry with TAx ACURATE neo implanta- the preferred alternative as recommended by Schofer et al5 unless tions performed up to May 2019 as the only inclusion criteria and with- anatomical or clinical conditions precluded use of the left side and, out any exclusion criteria. The study was approved by the local ethics then, right TAx was selected. committee. Importantly, TAx access is considered when puncture is performed beyond the first rib and was used in most cases; cases with surgical cut-down used trans-subclavian approach tough. All clinical and 2.3 | Statistical analysis imaging characteristics (including echocardiography and computed tomography scans) were collected at baseline. Procedural, in-hospital, Categorical variables are reported as number (percent) and continuous and 1-year follow up outcomes were recorded according to Valve Aca- variables as mean (standard deviation) or median (25th to 75th inter- demic Research Consortium-2 (VARC-2).12 Computed tomography quartile range), depending on variable distribution. Pearson χ2 test (CT) were analyzed in a dedicated core laboratory. Clinical outcomes and Fisher´s exact test were performed in comparisons between and echocardiographic findings were based on institutional self-report. groups with qualitative variables, and Student's t-test or Mann– Follow up was pre-specified at 1-year and was obtained for all patients. Whitney test in continuous variables. Finally Kaplan–Meir survival The primary outcomes included successful procedure according to curves were performed for the analysis of survival up to 1-year for VARC-2 criteria and 1-year global mortality. Secondary outcomes the entire population. All tests were two sided at the .05 significance included acute and late vascular complications and their management, level. Statistical analysis was performed with IBM SPSS Statistics ver- cerebrovascular events, and respiratory complications. sion 25 (IBM, Armonk, NY). 3 AMAT-SANTOS ET AL. F I G U R E 1 Step-by-step fully percutaneous implantation of ACURATE neo valve. (a) Axillar artery puncture with fluoroscopy guidance. Peripheral balloon is advanced for vascular hemostasia. (b) Pre-closure performed with Proglide® (Abbot Vascular). (c) Preformed Safari® (Boston Scientific) wire is placed in left ventricle and angiography of aortic root is performed. (d) Predilation with 20 mm balloon under rapid pacing. (e) ACURATE neo® (Boston Scientific) delivery system is advanced through the 18F Lotus sheath placed within the left axillar artery. (f) Released valve in optimal position with no leakage. (g) Inflated vascular balloon during closure of the percutaneous suture. (h) Final axillary angiography with optimal result 3 3.1 RESULTS | | Baseline clinical and imaging characteristics 3.2 | Procedural and in-hospital outcomes As shown in Table 2, left axillary approach (72%) and conscious sedation (95.2%) were the most common setting. Reasons for selecting A total of 75 patients were included in the study. Their main baseline right axillary artery were the presence of patent left internal mammary characteristics are summarized in Table 1. Mean age was artery in two cases, pacemaker implanted over potential left puncture 79 ± 10 years and 32% were women. The preoperative surgical risk site in one case, and small size of the left axillary artery in the according to the Society of Thoracic Surgeons and the EuroSCORE-II remaining cases. Preclosure was performed with Proglide® in all but were 3.9% [IQR: 1.3–6.5] and 2.6% [1.2–4.9], respectively. two cases (in both MANTA device was used) and 14FR iSLEEVE 4 AMAT-SANTOS ET AL. T A B L E 1 Baseline clinical and imaging characteristics in the global study population, according to the right or left trans-axillary approach, and according to the use of fully-percutaneous or surgical cut-down Variables Global population n = 75 (100%) Right axillary approach n = 21 (28%) Left axillary approach n = 54 (72%) p-value Percutaneous pre-closure n = 68 (90.6%) Surgical cut-down n = 7 (9.4%) p-value Clinical characteristics Age (years) 79 ± 10 81 ± 7 78 ± 7.5 .101 78.5 ± 7.4 84.6 ± 4.3 .360 Gender (%, female) 24 (32) 8 (38.1) 16 (29.6) .480 19 (27.9) 5 (71.4) .031 Diabetes 32 (42.7) 9 (42.9) 23 (42.6) .983 30 (44.1) 2 (28.6) .692 Prior PCI 35 (46.7) 8 (38.1) 27 (50) .353 32 (47.1) 3 (42.9) .999 Prior CABG 8 (10.7) 2 (9.5) 6 (11.1) .999 8 (11.8) 0 .999 Prior valve surgery* 5 (6.7) 1 (4.8) 4 (7.4) .999 5 (7.4) 0 .999 Cerebrovascular disease 41 (54.7) 12 (57.1) 29 (57.3) .788 37 (54.4) 4 (57.1) .999 Prior atrial fibrillation 32 (42.7) 6 (28.6) 26 (48.1) .124 29 (42.6) 3 (42.9) .999 COPD 20 (26.7) 3 (14.3) 17 (31.5) .131 19 8 (27.9) 1 (14.3) .667 Chronic kidney disease 35 (46.7) 8 (38.1) 27 (50) .353 30 (44.1) 5 (71.4) .241 STS score 3.9 [1.3–6.5] 4.2 [3.6–5.7] 2.5 [1.1–6.5] .127 3.9 [1.2–6.4] 3.6 [3.4–11] .269 EuroSCORE-II 2.6 [1.2–4.9] 4.4 [2.8–5.7] 1.9 [1.2–4.4] .007 2.4 [1.1–4.7] 4.7 [3.5–11] .038 Echocardiographic variables Aortic valve area, cm2 0.78 [0.6–0.9] 0.72 [0.6–0.81] 0.8 [0.65–0.9] .157 0.78 [0.6–0.9] 0.75 [0.5–0.81] .532 Mean aortic gradient, mmHg 45 [31–54] 42 [28–47] 46 [35–55] .338 43 [36.5–47.5] 42 [30–49] .863 LVEF, % 56 ± 11.6 61.5 ± 7.5 53.8 ± 12.3 .002 56.3 ± 11.7 53 ± 11.5 .478 Computed tomography variables AA area, mm2 469 ± 61 461 ± 66 473 ± 59 .455 469 ± 63 467 ± 39 .929 Eccentricity index 0.18 [0.11–0.22] 0.15 [0.09–0.17] 0.2 [0.14–0.27] .027 0.17 [0.13–0.24] 0.19 [0.16–0.20] .373 AA calcification (AU) 2,751 ± 1,362 2,382 ± 807 3,014 ± 1,558 .074 2,770 ± 1,354 2,671 ± 1,208 .795 Electrocardiographic findings Left bundle branch block 6 (8) 0 6 (11.3) .175 6 (9) 0 .999 Right bundle branch block 5 (6.7) 3 (14.4) 2 (3.8) .135 5 (7.5) 0 .999 Abbreviations: AA, aortic annulus; AU, Agatston units; CABG, coronary artery bypass graft; COPD, chronic obstructive pulmonary disease; EuroSCORE, European system for cardiac operative risk evaluation; LVEF, left ventricular ejection fraction; PCI, percutaneous coronary intervention; STS, Society of Thoracic Surgeons. a Only one case of aortic prosthesis, the other cases are in mitral position. (63, 84%) or 18Fr LOTUS introducer sheath (12, 16%) were used and to open surgery (1.3%). Access site closure was performed in all cases advanced to the proximal segment of subclavian artery. with peripheral balloon inflated within subclavian artery. In seven cases Predilation was performed in 66.7% and postdilation in 24% of the (9.3%) bail-out vascular stenting was required due to overt bleeding in cases. Valve sizes used are reported in Table 2, with “M” size as the three cases and incipient pseudoaneuryms in four. Surgical vascular most commonly used (54.7%). Severe complications including valve repair was necessary in three cases, all due to complication of cut-down embolization, coronary obstruction, annulus rupture, and procedural procedure. Overall, procedural success was 96%. mortality did not occur in any case. Cardiac tamponade before valve During the hospital stay, the need for new permanent pacemaker deployment occurred in two cases (2.7%) with one requiring conversion implantation was 8% in the global study population. Cerebrovascular 5 AMAT-SANTOS ET AL. T A B L E 2 Procedural characteristics and in-hospital outcomes in the global study population, according to the right or left trans-axillary approach, and according to the use of fully-percutaneous or surgical cut-down Global population n = 75 (100%) Right axillary approach n = 21 (28%) Left axillary approach n = 54 (72%) pvalue Percutaneous pre-closure n = 68 (90.6%) Surgical cut-down n = 7 (9.4%) pvalue General anesthesia 7 (4.8) 0 7 (13) .084 3 (4.4) 4 (57.1) <.001 Left axillary approach 54 (72) — 100 (100) — 50 (73.5) 4 (57.1) .392 Predilation 50 (66.7) 18 (85.7) 32 (59.3) .029 44 (64.7) 6 (85.7) .413 Postdilation 18 (24) 0 18 (33.3) .002 18 (26.6) 0 .184 Contrast (cc) 241 ± 110 179 ± 93 252 ± 110 .065 251,109 132 ± 46 .019 Fluoroscopy duration (min) 32.3 ± 15 19.1 ± 7.2 34.4 ± 14.9 .006 33.4 ± 14.9 17.1 ± 6.3 .035 S 9 (12) 4 (19) 5 (9.3) .245 8 (11.8) 1 (14.7) .845 M 41 (54.7) 12 (57.1) 29 (53.7) .788 37 (54.4) 4 (57.1) .890 Variables Procedural characteristics Valve size L Percutaneous closure 25 (33.3) 6 (28.6) 19 (35.2) .585 23 (33.8) 2 (28.6) .779 68 (90.6) 18 (85.7) 50 (92.6) .392 100 (100) 0 - Vascular balloon 10 (13.3) 0 10 (18.5) .053 10 (14.7) 0 .584 Bail-out vascular stent 7 (9.3) 0 7 (13) .180 7 (10.3) 0 .999 Bail-out vascular surgical repair 3 (4) 1 (4.8) 2 (3.7) .999 2 (2.9) 1 (14.3) .258 Valve embolization 0 0 0 — 0 0 — Coronary obstruction 0 0 0 — 0 0 — Annulus rupture 0 0 0 — 0 0 — Cardiac tamponade 2 (2.7) 1 (4.8) 1 (1.9) .484 2 (2.9) 0 .999 Conversion to open heart surgery 1 (1.3) 0 1 (1.9) .999 1 (1.5) 0 .999 Procedural success 72 (96) 20 (95.2) 52 (96.3) .999 65 (95.6) 7 (100) .999 Procedural mortality 0 0 0 — 0 0 — Aortic valve area, cm2 1.65 [1.45–1.95] 1.65 [1.45–1.95] 1.6 [1.45–1.85] .999 1.6 [1.45–1.95] 1.65 [1.45–1.85] .999 Mean aortic gradient, mmHg 7 [5–10] 6 [4–7] 7 [6–11] .008 7 [6–10] 6 [3–7] .139 LVEF, % 55.6 ± 11.8 58.3 ± 10.8 54.6 ± 12.1 .241 55.9 ± 12.1 52.6 ± 10.1 .483 Length of hospital stay (day) 8 [6–15] 6 [4–8.5] 7 [7–17] .004 7 [6–11.5] 8 [3–8] .380 Length of ICU stay (days) 2 [1–3] 1.5 [1–3] 2 [1–3] .677 2 [1–3] 1 [1–2] .116 Sepsis 6 (8) 0 6 (11.1) .182 5 (7.5) 1 (14.3) .396 Permanent pacemaker implantation 6 (8) 4 (20) 2 (3.8) .044 5 (7.5) 1 (14.3) .396 Minor vascular complication 6 (8) 0 6 (11.1) .182 6 (9) 0 .999 Major vascular complication 11,814.7) 3 (15) 8 (14.8) .999 8 (11.9) 3 (42.9) .062 Minor bleeding 7 (9.3) 1 (5) 6 (11.1) .666 3 (4.5) 4 (57.1) .001 Echocardiographic outcomes In-hospital clinical outcomes Major bleeding 5 (6.7) 0 5 (9.3) .315 4 (6) 1 (14.3) .400 Life-threatening bleeding 2 (2.7) 0 2 (3.7) .999 2 (3) 0 .999 Myocardial infarction 2 (2.7) 0 2 (3.7) .999 2 (3) 0 .999 (Continues) 6 AMAT-SANTOS ET AL. TABLE 2 (Continued) Variables Global population n = 75 (100%) Right axillary approach n = 21 (28%) Left axillary approach n = 54 (72%) pvalue Percutaneous pre-closure n = 68 (90.6%) Surgical cut-down n = 7 (9.4%) pvalue Cerebrovascular event 1 (1.3) 1 (5) 0 .270 1 (1.5) 0 .999 New onset atrial fibrillation 5 (6.7) 3 (15) 3 (3.7) .118 5 (7.5) 0 .999 In-hospital mortality 2 (2.7) 0 2 (3.7) .999 1 (1.5) 1 (14.3) .181 Abbreviations: ICU, intensive care unit; LVEF, left ventricular ejection fraction. T A B L E 3 Echocardiographic and clinical outcomes at 1-year follow up in the global study population, according to the right or left transaxillary approach, and according to the use of fully-percutaneous or surgical cut-down Global population n = 75 (100%) Variables Right axillary approach n = 21 (28%) Left axillary approach n = 54 (72%) pvalue Percutaneous pre-closure n = 68 (90.6%) Surgical cut-down n = 7 (9.4%) pvalue Echocardiographic outcomes Aortic valve area, cm2 1.93 [1.6–2.1] 2 [1.6–2.2] 1.7 [1.4–2.1] .160 2 [1.6–2.1] 1.9 [1.5–2] .999 Mean aortic gradient, mmHg 6 [5–8] 5.5 [5–8] 6 [5–8] .812 6 [5–8] 5 [4.5–6.1] .517 LVEF, % 58.4 ± 10.9 57.6 ± 9.2 58.8 ± 12.1 .711 58.1 ± 11 62.7 ± 9.7 .487 Aortic regurgitation 3–4 1 (1.3) 0 1 (3.8) .999 1 (2.4) 0 .999 Mitral regurgitation 3–4 1 (1.3) 0 1 (3.8) .999 1 (2.4) 0 .999 Tricuspid regurgitation 3–4 3 (4) 2 (10.5) 1 (4) .570 3 (7.3) 0 .999 Systolic pulmonary pressure (mmHg) 42.3 ± 13.8 40.1 ± 8.9 44 ± 16.8 .465 43.3 ± 1713.8 30 ± 7 .196 1-year follow up clinical outcomes Re-admission 30 (40) 10 (50) 20 (30.7) .342 28 (42.4) 2 (28.6) .692 NYHA class III-IV 7 (9.3) 3 (14.3) 4 (7.4) .392 5 (7.4) 2 (28.6) .126 Vascular access related complication 3 (4) 0 3 (5.6) .555 3 (4.4) 0 .999 1-year mortality 6 (8) 3 (14.3) 3 (5.6) .340 5 (7.4) 1 (14.3) .456 Abbreviations: LVEF, left ventricular ejection fraction; NYHA, New York Heart Association. events occurred in 1 (1.3%) case (right percutaneous TAx) and in- 4 | DI SCU SSION hospital mortality in two cases (2.7%). This is the first description of TAx approach for the implantation of the ACURATE neo transcatheter aortic valve. The main findings of this 3.3 | Main outcomes at 1-year follow up research are: 1/TAx approach for ACURATE neo was associated with high rate of success (96%) and low rates of stroke (1.3%), in-hospital and The main echocardiographic and clinical outcomes at 1 year follow up 13 according to Valve Academic Research Consortium-2 are summarized 1-year mortality (2.7% and 8%, respectively); two/only three cases (4%) required bail-out stenting due to failed percutaneous closure and bleeding. in Table 3. Only one patient (1.3%) had moderate aortic regurgitation before hospital discharge and progressed to severe at 1-year follow up. During follow up, three patients presented complications related to the vascular approach including a pseudoaneurysm at puncture site that 4.1 | Specific aspects of ACURATE neo for TAx approach was treated conservatively and two cases of persistent mild paresthesia with preserved strength and no evidence of limb ischemia. The delivery system of the ACURATE neo valve is specifically designed The 1-year global mortality rate was 8% as depicted in Figure 2. for the TF approach. Therefore, several features need to be taken into Three cases had cardiovascular mortality due to progressive heart fail- consideration when selecting the TAx approach. First, the 14F iSLEEVE ure in two of them and a stroke in one, and five cases had non- expandable introducer should be handled carefully in the axillary access cardiovascular mortality. because if only part of the sheath is advanced within the vessel, this 7 AMAT-SANTOS ET AL. is deeper and this might difficult the tightening of the Proglide® knots. Doing so over the inflated balloon can facilitate these maneuvers and reduce the risk of pushing the artery into the thorax. In addition, compressing the artery is not always possible and for this reason the threshold for stent implantation was low as recommended.5 Our research suggests that the rate of procedural complications was similar to TF series and at one-year there were not major complications. However, the adjunct endovascular stent placement in ~9% of the cases, though in agreement with prior series from this approach5 and also suggesting a comparable invasiveness of TAx and TF TAVR,7 raises the question whether in the long-term would there be specific complications (i.e., stent thrombosis or restenosis). Our recommendation is that, in the presence of pseudoaneurysm or small bleeding, prolonged (5 to 10 min) intravascular balloon inflation has to be performed and often is enough for adequate resolution of the complication. F I G U R E 2 Survival curve of the global study population [Color figure can be viewed at wileyonlinelibrary.com] 4.3 Other procedural aspects | Regarding the secondary arterial access, in most cases a transfemoral leads to the potential risk of bleeding around the introducer after it 7F introducer was used. Through this access, a 5F pigtail catheter was expands once the valve has been advanced through it. One potential advanced for aortic angiographies. In addition, a long Terumo® stiff alternative is the 18F LOTUS introducer sheath; given its hydrophilic wire was advanced in parallel through the same femoral introducer coating, careful fixation of this system ought to be performed to avoid and externalized with a snare through a radial introducer ipsilateral to in and out movements that might cause arterial damage. the main access. When femoral access was not possible, contralateral Other important aspect is the need for predilation. This step is radial or humeral arteries were used. highly recommended in all ACURATE neo procedures. Since non-TF A minimalistic approach is increasingly recommended in TAVR cases tend to have greater valvular calcification it is crucial in ACURATE procedures.15 TAx approach is also feasible under conscious seda- neo cases to perform an aggressive predilation that might help to reduce tion16 and, in our experience, patients do not experience more dis- the relatively high rate of postdilation, which is a known factor associ- comfort through this approach than through TF approach.17 14 ated with stroke, conduction disturbances, and even annular rupture. Regarding the need for pacemaker, it has been previously described the poorer alignment of alternative TAVR devices when the right axillary 4.4 Limitations | approach is selected5 and therefore left approach should be prioritize even in the presence of a definitive pacemaker in the left side. There are certain limitations derived from the retrospective design of the Finally, the ACURATE neo delivery system presents an external study. First, the selection of ACURATE neo device was done after anatom- layer covering part of the shaft that allows, while turning the knobs, ical assessment of the cases with CT and might not be valid for all poten- the top-to-down deployment. In TF cases the transition between the tial candidates to TAx TAVR. Second, angiographic and echocardiographic non-covered and the covered shaft is within the vascular anatomy analysis were not centrally analyzed and the optimal position of the valve during the valve deployment; conversely, during TAx implantation this could not be assessed. However, the rates of permanent pacemaker and transition is outside the patient. It is crucial to avoid holding the deliv- residual aortic regurgitation suggest adequate procedural planning. This ery system from the covered part of the sheath – instead of the distal registry was performed in high-volume institutions with large prior experi- portion of the sheath – to avoid the risk of undesired advancement of ence implanting TF ACURATE neo, which probably had an impact in the the valve during the deployment that might increase the risk of valve outcomes through TAx approach. Such prior TF experience is probably embolization. However, the covered shaft segment is longer in the advisable to any institution planning to start a TAx TAVR program with new ACURATE neo 2 device solving this problem. this device. 4.2 5 | Acute and late vascular complications | CONC LU SIONS The rate of percutaneous closure failure was below 4%, similar to that of Transaxillary TAVR procedures with the ACURATE neo valve were TF procedures7 but also four cases of pseudoaneurysm were treated with feasible and safe, with high success rate and low in-hospital and stent implantation and one more conservatively. Often transaxillary artery 1-year mortality rates. 8 AMAT-SANTOS ET AL. CONF LICT OF IN TE RE ST Dr. Amat-Santos is proctor for Boston Scientific. Dr. Nombela-Franco and Dr. Conradi are proctors for Abbot Vascular. DATA AVAI LAB ILITY S TATEMENT Data available on request due to privacy/ethical restrictions ORCID Ignacio J. Amat-Santos https://orcid.org/0000-0002-2311-4129 Luis Nombela-Franco https://orcid.org/0000-0003-3438-8907  https://orcid.org/0000-0002-3230-6368 Alvaro Aparisi RE FE R ENC E S 1. Brennan JM, Holmes DR, Sherwood MW, et al. The association of transcatheter aortic valve replacement availability and hospital aortic valve replacement volume and mortality in the United States. Ann Thorac Surg. 2014;98:2016-2022. 2. Cribier A, Eltchaninoff H, Bash A, et al. Percutaneous trans- catheter implantation of an aortic valve prosthesis for calcific aortic stenosis: first human case de-scription. Circulation. 2002;106:3006-3008. 3. Kurra V, Schoenhagen P, Roselli EE, et al. Prevalence of significant peripheral artery disease in patients evaluated for percutaneous aortic valve insertion: Preproce- dural assessment with multidetector computed tomography. J Thorac Cardiovasc Surg. 2009;137:1258-1264. 4. Caceres M, Braud R, Roselli EE. 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