Abstract
Background
The axillary artery is an alternative access- site for transcatheter aortic valve implantation (TAVI) when femoral arteries are unfavourable. Simplified transaxillary-TAVI (TAx-TAVI) is performed completely percutaneously, using vascular closure device (VCD) techniques for arteriotomy closure. Concerns exist regarding major vascular complications with this technique. This registry-study describes off-label VCD use during simplified TAx-TAVI.
Methods
Consecutive severe aortic stenosis patients unsuitable for both surgery and transfemoral access were enrolled in our heart valve registry and underwent simplified TAx-TAVI using VCDs for arteriotomy closure. At the operator’s discretion, closure was performed with a collagen-based plug (MANTA) or a suture-based system (double ProGlide). The primary endpoint was axillary access-related major vascular complications in hospital and at 30 days according to Valve Academic Research Consortium (VARC-3) definitions. Secondary endpoints included axillary access-site bleeding and all-cause mortality during hospitalisation to 30 days post-TAx-TAVI.
Results
From January 2022 to January 2024, 32 patients (mean age 77 years, 31.3% female) underwent simplified TAx-TAVI using VCDs. MANTA and ProGlide were each used in 50.0% of cases (n=16). Local anaesthesia with conscious sedation was used in 21.9% (n=7). Overall VARC-3 device success was 96.9% (31/32). VCD failure occurred in 25.0% (8/32) and was numerically more frequent with ProGlide (31.3%) than MANTA (18.8%). A covered stent was required for definitive axillary haemostasis in 12.5% (4/32). The 30-day axillary major vascular complication rate was 3.1% (1/32). No major bleeding complications occurred. All-cause 30-day mortality was 3.1% (1/32). New permanent pacemaker implantation occurred in 12.5% (4/32). At 30 days, New York Heart association (NYHA) class improved by at least one category in 68.8% (22/32).
Conclusions
In these simplified TAx-TAVI cases, MANTA and ProGlide VCDs performed well in terms of vascular and bleeding complications. Simplified TAx-TAVI requires advanced access-site management skills, including covered stent use. We found VCDs approved for femoral use safe with axillary access.
Keywords: Aortic Valve Stenosis, Transcatheter Aortic Valve Replacement, Peripheral Vascular Diseases
WHAT IS ALREADY KNOWN ON THIS TOPIC
Aortic stenosis patients who are not candidates for surgical aortic valve replacement and who have hostile femoral vessels require alternative access routes for transcatheter aortic valve replacement; however, these alternative routes are associated with an increased risk for complications and longer hospitalisations. Simplified, fully percutaneous transaxillary aortic valve implantation using vascular closure devices off-label may represent a safe alternative, but there is only limited clinical data regarding this.
WHAT THIS STUDY ADDS
This study demonstrates that fully percutaneous transaxillary access for transcatheter aortic valve implantation using either collagen-based or suture-based vascular closure devices is safe, efficacious and avoids surgical cutdowns.
HOW THIS STUDY MIGHT AFFECT RESEARCH, PRACTICE OR POLICY
This study provides additional data, which can be used to guide current operators and which can be included in future meta-analyses. Both vascular closure devices performed acceptably, but, unlike a prior report, we had a numerically fewer failures with the collagen-based plug.
Introduction
Transcatheter aortic valve implantation (TAVI) is a well-established intervention for severe aortic stenosis. This is particularly true for patients with multiple comorbidities and in the frail elderly; however, even moderate and lower risk patients benefit from TAVI.1,6 Although typically performed via the femoral arteries, thoracic (apex and direct aortic) and upper body (transcarotid, subclavian and axillary) arterial routes can be used when the femoral arteries are unsuitable. However, these alternative routes can pose an increased risk for less favourable outcomes.7,14 US and European registry data suggest that non-transfemoral routes are needed in approximately 15% of TAVI patients.12 This represents a significant number of patients and optimisation of interventions using these alternative routes is clinically relevant.
Alternative access routes have typically required surgical involvement and more general anaesthesia, which prolong the procedure time and in-hospital stay.714,18 Patient anatomy and centre expertise are considered the determining factors for access route choice.18 However, the feasibility of completely percutaneous transaxillary approaches, including a simplified transaxillary TAVI (TAx-TAVI) approach that ideally uses local anaesthesia with conscious sedation, ultrasound-guided axillary artery access and arteriotomy closure with vascular closure devices (VCDs) is becoming more widely used in cases with difficult ilio-femoral anatomy.78 13 15 19,21
Of note, VCD techniques are approved for transfemoral use but their use in TAx-TAVI is off-label. A meta-analysis has found that VCDs can be used safely for various interventional procedures performed using a transaxillary approach.20
We report here our early experience with a simplified, fully percutaneous TAx-TAVI approach in patients without suitable femoral access, focusing on the off-label use of two VCD strategies for axillary arteriotomy closure: collagen-plug based (MANTA) and suture-based (double ProGlide)
Methods
Patients and data collection
All patients scheduled for TAx-TAVI at Zentralklinik Bad Berka’s Structural Heart Disease Department were anonymously entered in our local database from January 2022 to January 2024, after providing informed consent for the procedure.
Decisions regarding TAVI versus valvular surgery, access route, VCD type and anaesthesia were made by our interdisciplinary Heart Team, which consists of cardiologists, cardiac surgeons, heart valve nurses and anaesthetists. CT was used to evaluate the femoral artery status and the potential use of large bore sheaths and dedicated closure systems. Likewise, the axillary artery was evaluated regarding its suitability as an access route for large sheaths. The axillary artery was required to have a diameter of >5.5 mm. Figures1 2 demonstrate axillary artery screening, sizing, and puncture site reconstruction. Relevant patient demographics, comorbidities, clinical status, ECG, echocardiography, CT and procedural data were recorded in the database. Adverse events were classified according to the Valve Academic Research Consortium II consensus document (VARC-II).22 VARC-3 was used to determine the device success rate.23 At 30 days post-TAVI, all patients had a telephone interview.
Figure 1. Determining axillary artery diameter. (A) Three-dimensional reconstruction of right/left subclavian and axillary arteries. (B) Fluoroscopic view. (C) Determining left axillary artery diameter.
Figure 2. Detailed reconstruction of axillary artery for puncture. (A) Reconstruction in complete length. (B) Reconstruction of mid axillary artery. (C) Reconstruction of axillary artery puncture site.
Fully percutaneous TAx-TAVI procedure
Our completely percutaneous transaxillary artery approach to TAVI was performed in a hybrid catheterisation laboratory and has been described in detail elsewhere.10 The choice of general anaesthesia or local anaesthesia with conscious sedation was up to the Heart Team, taking into consideration the opinions of both the operator and anaesthetist. Ultrasound-guided puncture of the vessel and large bore access to the axillary artery was performed in the deltopectoral groove so as to avoid entry into the thoracic space and prevent lung injury. Furthermore, effective manual haemostasis was achieved at this anatomical landmark. Access via the left side was preferred except when the left internal mammary artery had been used for coronary bypass surgery or when there were other suboptimal vessel conditions such as severe tortuosity, atherosclerotic disease or heavy calcium burden. In these and similar situations, the operator was free to switch to the right axillary artery. A 7F Slender sheath (Terumo Corp., Somerset, NJNew Jersey, USA) was inserted into the radial or ulnar artery contralateral to the axillary artery being used for the procedure. A pigtail catheter served as an angiographic catheter with sideports and was also inserted here for invasive pressure monitoring. On the ipsilateral side, a 7F sheath was inserted into the left radial artery to accommodate a bail-out balloon and covered stent in case of VCD failure. The TAVI procedure was performed according to manufacturer recommendations for the particular valve selected. Contemporary transcatheter heart valves were used: Evolut Pro+or Evolut FX (Medtronic Inc., Minneapolis, MN Minnesota, USA), Acurate neo 2 (Boston Scientific SciMed Inc, Marlborough, MA Massachusetts, USA), SAPIEN 3 (Edwards Lifesciences, Irvine, CA California, USA).
Closure of the large bore arteriotomy was performed with either a MANTA collagen-based plug (size 18F; Teleflex Wayne, PA Pennsylvania, USA) or with two suture-based ProGlide devices (Abbott Cardiovascular; Chicago, IL Illinois, USA). Both of these VCDs were being used off-label, and the choice of which one to use was ultimately left to the operator.
After the procedure was completed, a 6F pigtail catheter was placed over the indwelling safety wire on the ipsilateral artery distal to the arteriotomy closure for angiography at the end of the procedure. In the case of uncontrollable major bleeding, a balloon and/or covered stent could be placed via this route.
Haemostasis management
After completing the TAx-TAVI, a reduced dose of protamine (500 IU per 1000 IU of heparin) was routinely administered to lower the ACT to below 250 s. This was followed by VCD deployment. Due to its extra-thoracic location, the axillary artery can be easily manually compressed in the event of VCD failure. If residual bleeding was noted after VCD application, manual compression was applied for at least 5 min before considering additional VCDs or endovascular interventions. The total duration of manual compression and the decision to administer the full dose of protamine (1000 IU/1000 IU of heparin) were both left to the operator’s discretion.
An additional bail-out manoeuvre incorporated into our protocol included use of the Viabahn VBX balloon-expandable endoprosthesis (Gore Medical; Flagstaff, AZ Arizona, USA) for endovascular stenting, which is 7F compatible and can be advanced to the puncture site via the ipsilateral radial access route using a 7F slender sheath.
A peripheral angiogram was subsequently performed in accordance with our standard institutional practices to evaluate the effectiveness of closure and to identify any potential bleeding or vascular complications, which were managed as necessary. Any post-procedural stenosis was evaluated with standard angiographic analysis. Antiplatelet and anticoagulant therapy were continued post-TAVI according to standard practice.
Study parameters
This large case series was focused on the incidence of peri-procedural major vascular complications during simplified TAx-TAVI procedures and within 30 days post-procedure. Likewise, evaluated was the general safety and feasibility of simplified TAx-TAVI performed using either one of the two VCD strategies (MANTA or double ProGlide). Thus, data on mortality, stroke, coronary obstruction/myocardial infarction, acute kidney injury (AKI) stage 2–3, all major and minor vascular complications, VARC-II specified bleeding complications related to axillary access22 and new, permanent pacemaker implantation at 30 days were collected and evaluated.
Follow-up: in-hospital and at 30 days post-TAx-TAVI
A vascular ultrasound was performed at least once after the procedure and before discharge to exclude silent vascular injury or underestimated vascular stenoses. Patients were clinically monitored for the occurrence of adverse events during the in-hospital period. After 30 days, telephone interviews were conducted.
Statistics
Histograms were used for testing linear data for normal distribution. Non-parametric data are reported as median (25th–75th) CI. Comparisons between groups were assessed using the Mann-Whitney U-test, Pearson’s χ2 test, or Fisher’s exact test, as appropriate. A two-sided p<0.05 was considered statistically significant.
We used SPSS Statistics version V.29.0 (IBM Corp., Armonk, NY, USA) for all analyses.
Results
TAx-TAVI patient selection and enrollment
Between January 2022 and January 2024, 750 patients underwent TAVI at our institution. Of these, 32 (4.3%) underwent simplified TAx-TAVI and were enrolled in our database. TAx-TAVI was the primary alternative access route during this period, with only one transapical TAVI being performed as an alternative.
Baseline and procedural characteristics
Baseline demographics are found in table 1. The mean age of the TAx-TAVI cohort was 77.0 (69.5–83.0) years, 31.3% were female, and all were suffering from peripheral arterial disease or had suboptimal anatomy for a transfemoral TAVI. The mean Society of Thoracic Surgeons Predicted Risk of Mortality score was 4.6% (2.9%–6.2%). All patients were considered by the Heart Team to have high or prohibitive operative risk. Their risk profiles included frailty (n=10), porcelain aorta (n=2), previous thoracic surgery (n=8), advanced lung disease (n=1), cancer radiation (n=3), hostile chest (n=2), and poor left ventricular function combined with advanced age (n=3). Other factors were patient refusal of surgery (n=1) and explicit patient request (n=2).
Table 1. Baseline characteristics.
| Variable | Total cohort | MANTA | ProGlide | P value |
|---|---|---|---|---|
| Mean age, years (range) | 77.0 (69.5–83.0) | 73.0 (69.0–79.75) | 80.5 (71.25–84.0) | 0.146 |
| Female, n (%) | 10 (31.3) | 8 (50.0) | 2 (12.5) | 0.054 |
| Hypertension, n (%) | 22 (68.8) | 9 (56.3) | 13 (81.3) | 0.252 |
| Diabetes mellitus, n (%) | 16 (50.0) | 12 (75.0) | 4 (25.0) | 0.012 |
| Stroke/TIA, n (%) | 3 (9.4) | 2 (12.5) | 1 (6.3) | 1.000 |
| Peripheral vascular disease, N (%) | 28 (87.5) | 14 (87.5) | 14 (87.5) | 1.000 |
| COPD, n (%) | 14 (43.8) | 6 (37.5) | 8 (50.0) | 0.722 |
| Chronic kidney disease eGFR <35 mL/min/1.73 m², CKD-EPI, n (%) | 5 (15.6) | 3 (18.8) | 2 (12.5) | 1.000 |
| Previous myocardial infarction, n (%) | 8 (25.0) | 5 (31.3) | 3 (18.8) | 0.685 |
| Previous percutaneous coronary intervention, n (%) | 21 (65.6) | 7 (43.8) | 14 (87.5) | 0.009 |
| Previous coronary-artery bypass grafting, n (%) | 5 (15.6) | 1 (6.3) | 4 (25.0) | 0.333 |
| Previous TAVR, n (%) | 0 (0) | 0 (0) | 0 (0) | NC |
| Previous aortic valve surgery, n (%) | 0 (0) | 0 (0) | 0 (0) | NC |
| Previous non-aortic valve surgery, n (%) | 0 (0) | 0 (0) | 0 (0) | NC |
| Atrial fibrillation, n (%) | 19 (59.4) | 12 (75.0) | 7 (43.8) | 0.072 |
| Permanent pacemaker/ICD, n (%) | 9 (28.1) | 5 (31.3) | 4 (25.0) | 1.000 |
| NYHA functional class, n (%) | 0.677 | |||
| Class I | 1 (3.1) | 0 (0.0) | 1 (6.3) | |
| Class II | 7 (21.9) | 3 (18.8) | 4 (25.0) | |
| Class III | 19 (59.4) | 11 (68.8) | 8 (50.0) | |
| Class IV | 5 (15.6) | 2 (12.5) | 3 (18.8) | |
| STS-PROM score | 4.6 (2.9–6.2) | 4.6 (3.4–5.9) | 4.5 (2.2–7.4) | 0.821 |
| HAS-BLED score | 4.0 (3.0–5.8) | 3.0 (2.0–4.0) | 4.0 (4.0–7.0) | 0.006 |
| Baseline anticoagulation and anti-platelet therapy | ||||
| Vitamin K antagonist or DOAC, n (%) | 22 (68.8) | 13 (81.3) | 9 (56.3) | 0.127 |
| Aspirin, n (%) | 10 (31.3) | 3 (18.8) | 7 (43.8) | 0.127 |
| Clopidogrel or ticagrelor, n (%) | 8 (25.0) | 2 (12.5) | 6 (37.5) | 0.220 |
| Baseline echocardiogram | ||||
| LVEF (%) | 51 (43–58) | 51 (41–57) | 51 (45–60) | 0.637 |
| LVEF <25%, n (%) | 2 (6.3) | 1 (6.3) | 1 (6.3) | 1.000 |
| Aortic stenosis, n (%) | 32 (100) | 16 (100) | 16 (100) | 1.000 |
| Aortic regurgitation exceeding moderate level, n (%) | 9 (28.1) | 6 (37.5) | 3 (18.8) | 0.433 |
| Mitral regurgitation exceeding moderate level, n (%) | 8 (25.0) | 6 (37.5) | 2 (12.5) | 0.220 |
| Tricuspid regurgitation exceeding moderate level, n (%) | 5 (15.6) | 4 (25.0) | 1 (6.3) | 0.333 |
STS-PROM, Society of Thoracic Surgeons Predicted Risk of Mortality; TAVR, transcatheter aortic valve replacement.
Procedural characteristics are in table 2. General anaesthesia was used in 78.1% (n=25) of patients and local anaesthesia with conscious sedation in 21.9% (n=7) patients. Completely non-femoral access was used exclusively in 81.3% (n=26) of patients. The remaining six patients had a partial femoral procedure performed in that a 6F sheath was used for angiography via the femoral route. Left axillary artery access was used in 78.1% (n=25) and right axillary artery access in 21.9% (n=7) of patients. Three types of transcatheter heart valves were used: EvolutPro or EvolutFX (Medtronic, Minneapolis, MN, USA) with 14 Fr delivery system in 53.2% (n=17); Acurate Neo2/Acurate Neo 2 (Boston Scientific, Marlborough, MA, USA) in 21.9% (n=7); and Edwards Sapien 3 (Edwards Lifesciences; Irvine, CA, USA) in 25% (n=8). VARC-III device success was achieved in 96.9% (n=31).
Table 2. Procedural characteristics.
| Variable | Total cohort | MANTA | ProGlide | P value |
|---|---|---|---|---|
| Procedural characteristics | ||||
| Anaesthesia | ||||
| Conscious sedation, n (%) | 7 7 (21.9) | 5 (31.3) | 2 (12.5) | 0.394 |
| General anaesthesia, n (%) | 25 (78.1) | 11 (68.8) | 14 (87.5) | 0.394 |
| Valve-in-valve, n (%) | 0 (0) | 0 (0) | 0 (0) | NC |
| Valve type used, n (%) | 0.004 | |||
| EvolutPro | 10 (31.3) | 3 (18.8) | 7 (43.8) | |
| EvolutFX | 7 (21.9) | 6 (37.5) | 1 (6.3) | |
| Acurate neo 2 | 7 (21.9) | 6 (37.5) | 1 (6.3) | |
| Edwards SAPIEN 3 | 8 (25.0) | 1 (6.3) | 7 (43.8) | |
| More than one valve placed, n (%) | 2 (6.3) | 0 (0) | 2 (12.5) | 0.484 |
| Predilatation, n (%) | 26 (81.3) | 14 (87.5) | 12 (75.0) | 0.654 |
| Postdilatation, n (%) | 9 (28.1) | 4 (25.0) | 5 (31.3) | 1 |
| VARC-III device success, n (%) | 31 (96.9) | 15 (93.8) | 16 (100) | 1 |
| Immediate procedural mortality, n (%) | 0 (0) | 0 (0) | 0 (0) | NC |
| Embolisation, n (%) | 0 (0) | 0 (0) | 0 (0) | NC |
| Tamponade, n (%) | 0 (0) | 0 (0) | 0 (0) | NC |
| Contrast used (mL) | 88.0 (67.5–113.5) | 74.0 (59.2–89.2) | 104.5 (82.2–132.5) | 0.018 |
| Procedure time (min) | 74.5 (53.8–93.0) | 58.0 (52.0–70.2) | 89.5 (77.2–94.8) | 0.006 |
| Access-site-related characteristics | ||||
| Completely non-femoral, n (%) | 26 (81.3) | 14 (87.5) | 12 (75.0) | 0.654 |
| Axillary access side | ||||
| Left, n (%) | 25 (78.1) | 15 (93.8) | 10 (62.5) | 0.083 |
| Right, (%) | 7 (21.9) | 1 (6.3) | 6 (37.5) | 0.083 |
| Closure device | ||||
| MANTA, n (%) | 16 (50) | 16 (100) | ||
| Double ProGlide, n (%) | 16 (50) | 16 (100) | ||
| VCD failure–VARC III, n (%) | 8 (25.0) | 3 (18.8) | 5 (31.3) | 0.685 |
| Covered stent used, (%) | 4 (12.5) | 2 (12.5) | 2 (12.5) | 1 |
VARC, Valve Academic Research Consortium; VCD, vascular closure device.
A VCD was used for axillary arteriotomy closure in all 32 patients. A double ProGlide strategy was used in 50% (n=16) and MANTA (18F) also in 50% (n=16). According to the VARC-III criteria, there was VCD failure in 25% (n=8) of the patients. VCD failure occurred in 31.3% (n=5), of patients who received two ProGlide devices, and a covered stent was used in 12.5% (n=2) of these patients. Device failure occurred in 18.8% (n=3) of those who received MANTA devices, and a covered stent was used in 12.5% (n=2) of these failures. For all other patients with VCD failure, prolonged manual compression was sufficient to achieve haemostasis.
For the TAx-TAVI cohort overall, the median volume of contrast used was 88 mL (IQR 67.5–113.5) and the median procedure time was 74.5 min (IQR 53.8–93.0). Of note, contrast volume and procedure time were both significantly higher when closure was performed with two ProGlide devices as opposed to the MANTA device. (p=0.018 and p=0.006, respectively.)
Vascular and bleeding complications
Table 3 summarises complications that occurred in-hospital and within 30 days post-procedure. In terms of overall mortality, there was one death, which occurred in-hospital. AKI stage 2 occurred in 12.5% (n=4) and AKI stage 3 in 3.1% (n=1) patients. In-hospital major stroke occurred in 3.1% (n=1) and in-hospital new, permanent pacemaker implantation was necessary in 12.5% (n=4).
Table 3. Complications: in-hospital and within 30 days.
| Variable | Total cohort | MANTA | ProGlide | P value |
|---|---|---|---|---|
| In-hospital mortality, n (%) | 1 (3.1) | 0 (0.0) | 1 (6.3) | 1 |
| Cardiovascular cause, n (%) | 0 (0) | 0 (0) | 0 (0) | NC |
| Acute myocardial infarction, n (%) | 0 (0) | 0 (0) | 0 (0) | NC |
| Any stroke after procedure, n (%) | 2 (6.3) | 1 (6.3) | 1 (6.3) | 1 |
| Stroke in hospital | 1 (3.1) | 0 (0.0) | 1 (6.3) | |
| Stroke within 30 days of procedure | 1 (3.1) | 1 (6.3) | 0 (0.0) | |
| Any TIA after procedure, n (%) | 2 (6.3) | 2 (12.5) | 0 (0.0) | 0.484 |
| TIA in hospital | 1 (3.1) | 1 (6.3) | 0 (0.0) | |
| TIA within 30 days of procedure | 1 (3.1) | 1 (6.3) | 0 (0.0) | |
| Any new pacemaker after procedure, n (%) | 5 (15.6) | 3 (18.8) | 2 (12.5) | 1 |
| New permanent pacemaker in hospital | 4 (12.5) | 2 (12.5) | 2 (12.5) | |
| New permanent pacemaker within 30 days of procedure | 1 (3.1) | 1 (6.3) | 0 (0.0) | |
| Acute kidney injury (AKI) (KDIGO classification used) | ||||
| Any stage AKI | 5 (15.6) | 4 (25.0) | 1 (6.3) | 0.333 |
| Stage 1, n (%) | 0 (0) | 0 (0) | 0 (0) | NC |
| Stage 2, n (%) | 4 (12.5) | 4 (25.0) | 0 (0.0) | 0.101 |
| Stage 3, n (%) | 1 (3.1) | 0 (0.0) | 1 (6.3) | 1 |
| Non-access site -related complications | ||||
| Life threatening bleeding, n (%) | 0 (0) | 0 (0) | 0 (0) | NC |
| Major vascular complication, n (%) | 2 (6.3) | 1 (6.3) | 1 (6.3) | 1 |
| Delirium, n (%) | 4 (12.5) | 1 (6.3) | 3 (18.8) | 0.6 |
| Hospitalisation length (days) | 7 (5–9) | 6.5 (5–7) | 8 (5.2–10.8) | 0.171 |
| Access site -related complications | ||||
| Major, n (%) | 1 (3.1) | 0 (0.0) | 1 (6.3) | 1 |
| Minor, n (%) | 7 (21.9) | 4 (25.0) | 3 (18.8) | 1 |
| Reintervention at access site, n (%) | 1 (3.1) | 0 (0.0) | 1 (6.3) | 1 |
| Access site -related bleeding | ||||
| Life threatening | 0 (0) | 0 (0) | 0 (0) | NC |
| Major | 3 (9.4) | 0 (0.0) | 3 (18.8) | 0.226 |
| Minor | 5 (15.6) | 3 (18.8) | 2 (12.5) | 1 |
| Freedom from access site -related major vascular complication or major bleeding, n (%) | 31 (96.9) | 16 (100.0) | 15 (93.8) | 1 |
| Brachial plexus impairment at the access site arm | 1 (3.1) | 0 (0.0) | 1 (6.3) | 1 |
| Functional class at 30 days | ||||
| Any NYHA class improvement within 30 days of procedure, n (%) | 22 (68.8) | 12 (75.0) | 10 (62.5) | 0.446 |
The overall incidence of axillary artery access-related major vascular complications, both immediately post-intervention and at 30 days post-procedure, was 3.1% (n=1; access closure with ProGlide). In this patient, a malapposed covered stent was used, which resulted in arteriotomy site bleeding that necessitated a transfusion. After stent dilatation, bleeding ceased. There were three patients (18.8%) who had major access-site-related bleeding complications. All of these patients received two ProGlide devices, and all could be managed with manual compression. The number of access site reinterventions by day 30 in the entire cohort was one (3.1%), that is, the above-described patient, who underwent covered stent dilatation.
Minor access site-related complications occurred in seven patients (21.9%). Five patients (15.6%) had minor access site-related bleeding. VCD choice was not significantly associated with these minor complications.
One patient (3.1%) developed paresthesia of the left upper and lower arm due to a large haematoma in the region of the brachial nerve plexus. This was clinically apparent 5 days post-procedure and was no longer problematic at the 30-day follow-up.
NYHA functional class
NYHA functional class at 30 days was improved >1 grade in 68.8% (n=22), and VCD choice did not influence this (p=0.446)
Discussion
Findings in context of prior studies
In keeping with how rarely TAx-TAVI is performed, the available data on TAx-TAVI outcomes is limited. Furthermore, off-label use of VCDs for a simplified, fully percutaneous TAx-TAVI is even less well characterised. This case series describes our fully-percutaneous TAx-TAVI experience using two different VCD systems off-label; a collagen plug-based system or a suture-based closure system. The MANTA and ProGlide VCDs performed equally well for us in terms of vascular and bleeding complications. Unlike other alternative access routes, no surgical cut down was needed, which decreases patient morbidity.14 16 17 Contemporary data generally suggest comparable outcomes with percutaneous axillary access and transfemoral access.1821 24,27 Of the 2164 patients in the RISPEVA Registry, only 60 underwent TAx-TAVI, but for this minority percutaneous axillary access was associated with similar mortality and stroke compared with transfemoral TAVI, although with longer procedure times and possibly some differences in vascular complication profiles. There was no information regarding closure methods.24 In the German Aortic Valve Registry (GARY) of the 9686 patients who required non-transfemoral access, only 370 received a transaxillary approach and within this subgroup only 200 had a percutaneous approach. The GARY TAx-TAVI patients had more vascular complications and numerically more strokes than TAVI patients who received a transapical or transaortic approach; nevertheless, their hospital stay was shorter, their 30-day survival was better than the transapical cases, and their 1 year survival was better than the transaortic cases. No differences were found when percutaneous transaxillary and cut-down transaxillary were compared in GARY.21 The Hostile Registry sought to determine the best vascular access routes for patients with peripheral arterial disease who were undergoing TAVI. Here, TAVI performed via ‘non-thoracic transalternative access’ (mainly transaxillary) was associated with lower rates of major adverse events as compared with transthoracic access, but, in patients with only mild-moderate peripheral arterial disease, the transfemoral approach yielded lower rates of stroke or TIA at 1 year than the non-thoracic transalternative access.25 Data on TAVI patients from Belgium, Denmark, and the Netherlands who had difficult femoral access was also presented in NORTHOSTAVI (NORTh Europe HOStile access TAVI) registry. The alternative access routes were found to have good success rates and to be safe and efficient; however, TAx-TAVI was again associated with a higher adjusted rate of stroke and bleeding.26 Our numerical incidence of stroke or TIA was quite low, and no comparison with transfemoral-TAVI was made.
Comparison of VCDs
This project was not powered to detect differences between the MANTA and ProGlide closure systems. Rather, we can report that both systems were suitable for use in TAx-TAVI. Our early data suggest that both devices had comparable device success rates, but that there were differences in complication profiles. Notably, the ProGlide closure system was associated with a higher incidence of device-related failures (31.3% vs 18.8%) and access-site bleeding complications, although statistical significance (p=1.00) was not achieved. Nevertheless, a suture-based closure system could be technically more challenging in the axillary anatomy as precise deployment and tension control is required. Conversely, the plug-based MANTA device demonstrated slightly lower failure rates, likely owing to its simplified deployment mechanism. However, the potential for malapposition with MANTA underscores the need for operator expertise and appropriate patient selection. Nuis et al have also described their experience with both MANTA and ProGlide as VCDs after TAx-TAVI, with a particular focus on suture-based closure. Somewhat different from our cohort, they found fewer VCD failures and a lower frequency of access site bleeding complications associated with the suture-based system.27 Given the small sample size of both studies, it is unclear if these differences are meaningful.
The use of a ‘hybrid’ approach, for example, the combination of one ProGlide and one Angioseal, has been reported in the context of transfemoral TAVI. Rheude et al colleagues reported that the combination of one ProGlide+one Angioseal as a closure strategy for transfemoral TAVI was superior to a purely suture-based strategy in terms of major and minor access-site-related complications.28 How this translates in the setting of the axillary anatomy is yet to be clarified. Given the rarity of the TAx-TAVI procedure, a multi-centre study may be needed to evaluate this in the future.
Safety outcomes
Our low rates of major access-site vascular complications (3.1%) and in-hospital mortality (3.1%) are encouraging, particularly given the high-risk profile of this population. These results compare favourably with other reports of non-femoral access, which often cite increased complication rates due to anatomical and procedural complexity.12 Additionally, the absence of life-threatening bleeding and manageable rates of minor complications (21.9%) affirm the safety of this simplified approach. Importantly, our results highlight the necessity of a comprehensive haemostasis assessment and readiness to deploy bailout strategies, such as covered stents, to mitigate any access-site complications.
Although not an issue assessed in this study, it is worth noting here that, for centres with the requisite expertise, patient safety can also be further enhanced when, in selected cases, a wire loop is formed from the ipsilateral radial artery to the diseased femoral artery. This is reminiscent of the through-and-through wire technique used in endovascular aortic aneurysm repair and peripheral vascular procedures.29 In the TAx-TAVI setting, this technique allows for controlled, minimised manipulations with a reduced need for repeated catheter exchanges.
The role of anaesthesia in TAVI safety outcomes is a topical issue. During the observation period for this study, the majority of our TAx-TAVI patients still received general anaesthesia. That decision was made in conjunction with our anaesthesiologists. There has been increasing evidence, such as from the SOLVE-TAVI trial and the SOURCE 3 registry, that conscious sedation during transfemoral-TAVI yields similar outcomes and may make the need for inotropes and vasopressors in the periprocedural period less.30 31 Given that many transaxillary procedures were traditionally performed by means of a surgical cutdown, general anaesthesia was more commonly used with it. However, with fully percutaneous transaxillary procedures, the role of conscious sedation is expanding. A recent, multicentre registry out of the United Kingdom found fully percutaneous TAx-TAVI performed under conscious sedation to be a reasonable option for TAx-TAVI, although there may have been a signal for more stroke.32 This is an issue that needs to be further teased apart by means of a future, multicentre study.
Clinical implications
This study provides evidence supporting the routine use of TAx-TAVI with VCDs in select patients requiring alternative access routes. Furthermore, the study underscores the potential of simplified transaxillary access and vascular closure to reduce procedural invasiveness, which is consistent with broader trends towards fully percutaneous TAVI approaches and towards the tailoring of procedures to patient anatomy and comorbidities.15
Another point to be drawn from this study is the importance of maintaining alternative access skills and bailout skills. The increasing use of augmented femoral access procedures, such as intravascular lithotripsy (IVL) or percutaneous balloon angioplasty, might inadvertently cause operators to push the boundaries of femoral access to the point that their alternative access skills and bailout skills diminish. In particular, IVL, which uses acoustic shockwaves to ‘crack’ vascular calcium so that more patients with calcific stenoses of the iliofemoral arteries are candidates for transfemoral TAVI, has increased in use. While this is a positive development, as femoral access is always preferred, operators must still be able to use alternative access routes and to remain competent with bailout procedures as patients with severe peripheral arterial disease have an increased risk for procedural/periprocedural complications.33 Of note, there are no specific guidelines regarding augmented femoral access use and TAVI at the time of this writing, and the types of calcific lesions and patterns of calcium distribution that are best treated by IVL need to be clarified.34 Augmented femoral access is not a panacea, and alternative access skills remain necessary.
Limitations
This observational study used routine data collected from medical records and follow-up telephone interviews. In theory, the retrospective design limits control over data quality, but we had no missing data entries for any of the studied parameters, including the 30-day follow-up. The main limitation of this retrospective case series is the number of TAx-TAVI patients, which, due to the nature of the procedure, is small at all centres. This reduces statistical power and generalisability; however, precisely due to the rarity of the procedure, making such data known is necessary. We refrained from establishing prediction models due to the potential for overfitting, and the risk of producing biased estimates due to the small sample size.
Selection bias may be present as the choice of VCD was determined by the treating clinician rather than by randomisation; nevertheless, the number of procedures using ProGlide and the number of procedures using MANTA during the time period under study were the same. Although the same number of patients were treated with each VCD system, MANTA was preferred during procedures performed later in the observation period. We now primarily use the MANTA system for all TAVI procedures.
Conclusions
Simplified TAx-TAVI with percutaneous VCDs offers a safe and effective alternative for patients with limited femoral access options. Both MANTA and ProGlide systems are feasible for axillary use, but operator proficiency and patient-specific issues should be considered during procedure planning.
Footnotes
Funding: The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Patient consent for publication: Not applicable.
Provenance and peer review: Not commissioned; externally peer reviewed.
Ethics approval: This study involves human participants and was approved by the Ethics Committee of the State Medical Association of the Federal State of Thuringia.
Data availability statement
Data are available on reasonable request.
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Data Availability Statement
Data are available on reasonable request.