Transcatheter Aortic Valve Replacement Through a Single Femoral Access: A Multicenter Experience

Abstract

Objectives. During the past few years, physicians have optimized transcatheter aortic valve replacement and its periprocedural management, with the minimalist approach becoming popular. We aimed to further simplify the procedure using a single femoral access (the “all-in-one” technique). Here, we report a multicenter experience with TAVR with Acurate neo/neo2 transcatheter heart valves (Boston Scientific) through a single, large-bore, femoral sheath. Methods. Patients underwent TAVR with the Acurate neo or neo2 through a single femoral access at 4 centers. The large sheath was used for both the delivery catheter and the pigtail used to visualize the aortic root. Results. A total of 157 patients (59% women) with a mean age of 82 ± 6 years underwent TAVR with the Acurate neo (n = 100) or the Acurate neo2 (n = 57). The procedure was successfully performed through a single large sheath in all patients. Median duration of hospitalization stay was 2 days (interquartile range, 1-3 days). On echocardiography before discharge, the mean gradient was 7 ± 3 mm Hg and 7 patients (4.4%) had more than mild paravalvular leak. At 30 days, a major vascular complication had occurred in 2 patients (1.3%), 2 patients  (1.3%) had suffered a stroke, and only 4 patients (2.5%) had required new permanent pacemaker implantation. A total of 3 patients (1.9%) had died. Conclusions. An all-in-one access technique allows safe implantation of Acurate neo and neo2 transcatheter heart valves, with low rates of periprocedural complications and favorable short-term outcomes.

Keywords: aortic stenosis, complications, simplification, vascular

Transcatheter aortic valve replacement (TAVR) is routinely performed in inoperable, high-risk, intermediate-risk, and low-risk patients with low mortality and complication rates.^1-5 During the past years, physicians have optimized clinical patient pathways and the minimalist approach has become popular.⁶ The self-expanding Acurate neo transfemoral system (Boston Scientific) has received CE mark approval in 2014 and has design features aiming to prevent new conduction disorders. It has been associated with low rates of periprocedural high-degree atrioventricular blocks and new pacemakers in the initial TF89 cohort and in several multicenter registries.^7-10 The Acurate neo 2 United States investigational device exemption trial is currently enrolling patients.

In the present study, we aimed to further simplify the procedure using a single femoral access, using an “all-in-one” technique for TAVR with the Acurate neo or Acurate neo 2 transcatheter heart valve (THV). With this technique, the entire procedure can be performed through a single, large-bore, femoral sheath.

Methods

Between November 2019 and February 2022, patients undergoing TAVR at 4 centers in Switzerland, Canada, and Argentina were enrolled in a prospective registry. Data were collected throughout the initial hospital stay and at 30-day follow-up. Prospective data acquisition after TAVR was approved by the local ethics committees and all patients signed written informed consent. Clinical endpoints were defined according to the definitions of the Valve Academic Research Consortium.¹¹

Femoral access side was selected based on planning computed tomography and was obtained with ultrasound guidance. Preclosure/­closure was performed with either ProGlide sutures (Abbott Vascular) or with an 18-Fr Manta (Teleflex) according to institutional practice. After insertion of a 14-Fr expandable iSleeve or 18-Fr Lotus small sheath (Boston Scientific), the optimal implantation angle was chosen from computed tomography images and confirmed with an aortic root injection through a pigtail catheter within the large sheath. Thereafter, the pigtail was exchanged to an angled catheter to cross the aortic valve and position the stiff wire. Predilation was performed using rapid pacing over the stiff wire. The valve-delivery catheter was advanced up to the descending or ascending aorta. The hemostatic valve of the large sheath was punctured as peripherally as possible at 2 o’clock and a pigtail was inserted over a 5-Fr sheath or directly through the hemostatic valve (Figure 1 and Video 1). TAVR was then performed in standard fashion.

Results

Baseline characteristics and outcomes are listed in Table 1 and Table 2. A total of 157 patients (59% women) with a mean age of 82 ± 6 years underwent TAVR with the Acurate neo (n = 100) or the Acurate neo 2 (n = 57). The procedure was performed with conscious sedation in 150 patients (97%). A Sentinel cerebral embolic protection device (Boston Scientific) was used in 71 patients (45%). Predilation was performed in 142 patients (90%). Implantation of the Acurate neo/neo 2 was successfully performed in all patients through a single, large-bore, femoral sheath used for the valve catheter and the pigtail (Figure 1 and Video 1). Postdilation was required in 62 patients (39%). Median duration of the procedure was 45 minutes (interquartile range [IQR], 38-55). TAVR reduced the mean transvalvular gradient from 43 ± 13 mm Hg at baseline to 7 ± 3 mm Hg before discharge (P<.001). Paravalvular leak (PVL) was graded as none/trace in 52 (33%), mild in 98 (63%), and moderate in 7 patients (4%). A major vascular complication occurred in 2 patients (1.3%). Both patients had access-site bleeding; 1 was treated with manual compression and the other underwent implantation of a covered stent from the contralateral femoral artery. Median duration of hospitalization was 2 days (IQR, 1-3). At 30-day follow-up, 2 patients (1.3%) had suffered a stroke and 4 patients (2.5%) had required new permanent pacemaker implantation. A total of 3 patients (1.9%) had died.

Discussion

Based on the results of this multicenter experience, single arterial access for TAVR with Acurate neo/neo 2 THVs is feasible and safe. With the all-in-one technique, the large sheath is used for the valve catheter and the pigtail at the same time. In our study, this technique was associated with low rates of complications and a low procedural duration. Furthermore, this technique helps to reduce the number of arterial punctures for a secondary access, closure devices, and sheaths required for the procedure. Of note, we did not observe relevant leaking of the hemostatic valve. Only 1 of the 157 patients required insertion of an arterial contralateral sheath. While this technique seems appealing, it is not applicable for the Evolut (Medtronic) or Sapien THV (Edwards Lifesciences) due to the sheath needed itself and the device/sheath ratio precluding the advancement of a pigtail in parallel. Notably, the absence of a contralateral puncture might delay a bailout procedure in patients with vascular perforation and hemodynamic instability. Operator experience with good procedural and bailout planning is of paramount importance, should this occur. In summary, the all-in-one access may have the potential to reduce procedural duration, the number of required closure devices (and sheaths), and procedural costs.

Study limitations. This is an observational study. No core laboratory analysis was performed.

Conclusion

All-in-one access allows implantation of Acurate neo/neo2 THVs through a single large-bore femoral sheath.

Affiliations and Disclosures

From the ¹Heart Center Lucerne, Luzerner Kantonsspital, Lucerne, Switzerland; ²the Division of Cardiology, London Health Sciences Centre, Western University, London, Canada;³the Interventional Cardiology Department, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina; and ⁴the Department of Cardiology, Sanatorio Finochietto, Buenos Aires, Argentina.

Disclosure: The authors have completed and returned the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Toggweiler serves as a proctor and consultant for Boston Scientific, Medtronic, Abbott Vascular, Edwards Lifesciences, and Biosensors; consultant for Medira, atHeart Medical, VeoSource, Teleflex, Shockwave, and Polares Medical; institutional research grants from Boston Scientific, Fumedica, and Biosensors; equity in Hi-D Imaging. Dr Diamontouros serves as a proctor for Boston Scientific. Dr Agatiello serves as a proctor and speaker for Boston Scientific and Edwards Lifesciences. Dr Wolfrum serves as a consultant and proctor for Biosensors. Dr Sztejfman serves as a proctor for Boston Scientific; consultant and proctor for Medtronic. The remaining authors report no conflicts of interest regarding the content herein.

The authors report that patient consent was provided for publication of the images used herein.

Manuscript accepted April 27, 2022.

Address for correspondence: Matias Sztejfman, MD, Department of Cardiology, Sanatorio Güemes, Buenos Aires, Argentina. Email: sztejfman@gmail.com

References

1. Mack MJ, Leon MB, Thourani VH, et al. Transcatheter aortic-valve replacement with a balloon-expandable valve in low-risk patients. N Engl J Med. 2019;380(18):1695-1705. Epub 2019 Mar 16. doi:10.1056/NEJMoa1814052

2. Popma JJ, Deeb GM, Yakubov SJ, et al. Transcatheter aortic-valve replacement with a self-expanding valve in low-risk patients. N Engl J Med. 2019;380(18):1706-1715. Epub 2019 Mar 16. doi:10.1056/NEJMoa1816885

3. Stortecky S, Franzone A, Heg D, et al. Temporal trends in adoption and outcomes of transcatheter aortic valve implantation: a Swiss TAVI registry analysis. Eur Heart J Qual Care Clin Outcomes. 2019;5(3):242-251. doi:10.1093/ehjqcco/qcy048

4. Leon MB, Smith CR, Mack MJ, et al. Transcatheter or surgical aortic-valve replacement in intermediate-risk patients. N Engl J Med. 2016;374(17):1609-1620. Epub 2016 Apr 2. doi:10.1056/NEJMoa1514616

5. Adams DH, Popma JJ, Reardon MJ, et al. Transcatheter aortic-valve replacement with a self-expanding prosthesis. N Engl J Med. 2014;370(19):1790-1798. doi:10.1056/NEJMoa1400590

6. Wood DA, Lauck SB, Cairns JA, et al. The Vancouver 3M (multidisciplinary, ­multimodality, but minimalist) clinical pathway facilitates safe next-day discharge home at low-, medium-, and high-volume transfemoral transcatheter aortic valve replacement centers: the 3M TAVR study. JACC Cardiovasc Interv. 2019;12(5):459-469. doi:10.1016/j.jcin.2018.12.020

7. Schafer U, Conradi L, Diemert P, et al. Symetis Acurate TAVI: review of the technology, developments and current data with this self-expanding transcatheter heart valve. Minerva Cardioangiol. 2015;63(5):359-369. Epub 2015 Jul 22.

8. Toggweiler S, Nissen H, Mogensen B, et al. Very low pacemaker rate following Acurate neo transcatheter heart valve implantation. EuroIntervention. 2017;13(11):1273-1280. doi:10.4244/EIJ-D-17-00252

9. Kim WK, Hengstenberg C, Hilker M, et al. The SAVI-TF registry: 1-year outcomes of the European post-market registry using the Acurate neo transcatheter heart valve under real-world conditions in 1,000 patients. JACC Cardiovasc Interv. 2018;11(14):1368-1374. doi:10.1016/j.jcin.2018.03.023

10. Toggweiler S, Loretz L, Brinkert M, et al. Simplifying transfemoral Acurate neo implantation using the TrueFlow nonocclusive balloon catheter. Catheter Cardiovasc Interv. 2020;96(6):E640-E645. Epub 2020 Jan 23. doi:10.1002/ccd.28741

11. Kappetein AP, Head SJ, Genereux P, et al. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document. Eur J Cardiothorac Surg. 2012;42(5):S45-S60. Epub 2012 Oct 1. doi: 10.1093/ejcts/ezs533

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