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Erschienen in: Herz 5/2022

13.10.2021 | Original articles

First experiences with a new balloon-expandable Myval transcatheter aortic valve: a preliminary study

verfasst von: Ali Rıza Akyüz, M.D, Ali Hakan Konuş, M.D, Ömer Faruk Çırakoğlu, M.D, Sinan Şahin, Selim Kul, M.D, Levent Korkmaz, M.D

Erschienen in: Herz | Ausgabe 5/2022

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Abstract

Background

In the present article, we present our first experiences with a new type of balloon-expandable Myval valve (Meril Life Sciences, Gujarat, India).

Materials and methods

A total of 25 consecutive patients who underwent transcatheter aortic valve implantation (TAVI) from June 2020 to November 2020 were included in the study.

Results

The mean age of the study population was 83 (75–87) years; 17 (68%) were female, and 20 (80%) had hypertension. The Society of Thoracic Surgeons (STS) score of the group was 5.4% ± 3.5%. TAVI was performed via the transfemoral route on all patients. In 19 (76%) cases, we started the procedure without predilation. In two (10.5%) cases performed without predilation, the prosthesis did not pass the native valve. We had to implant the valve from the descending aorta in one (4%) patient. We used Prostar XL (Abbott Vascular, Santa Clara, CA, USA) for six (24%) patients and ProGlide (Abbott Vascular) for 19 (76%) patients for vascular closure. Two (8%) in-hospital deaths occurred in our study but there were no deaths in the 30-day and 90-day follow-up. Vascular complications were observed in one (4%) patient. None of the patients in our study had severe paravalvular leak (PVL), while two (8%) patients had moderate PVL. A permanent pacemaker (PPM) was required in two (8%) patients for the indication of complete atrioventricular block. The mean hospital stay for the whole group was 4 (3–7) days.

Conclusion

Based on our experiences, the new balloon-expandable valve Myval is easy to use, efficient, and has only a few negligible drawbacks such as the need for predilation of the sheath. While shaft flexibility may have advantages in some situations including in very tortuous arteries, it may cause some difficulties in alignment of the valves.
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Literatur
1.
Zurück zum Zitat Cribier A, Eltchaninoff H, Bash A, Borenstein N, Tron C, Bauer F et al (2002) Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis: first human case description. Circulation 106(24):3006–3008CrossRef Cribier A, Eltchaninoff H, Bash A, Borenstein N, Tron C, Bauer F et al (2002) Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis: first human case description. Circulation 106(24):3006–3008CrossRef
2.
Zurück zum Zitat Otto CM, Nishimura RA, Bonow RO, Carabello BA, Erwin JP 3rd, Gentile F et al (2021) 2020 ACC/AHA guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association joint committee on clinical practice guidelines. Circulation 143(5):e35–e71. https://doi.org/10.1161/CIR.0000000000000932CrossRefPubMed Otto CM, Nishimura RA, Bonow RO, Carabello BA, Erwin JP 3rd, Gentile F et al (2021) 2020 ACC/AHA guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association joint committee on clinical practice guidelines. Circulation 143(5):e35–e71. https://​doi.​org/​10.​1161/​CIR.​0000000000000932​CrossRefPubMed
3.
Zurück zum Zitat Mack MJ, Leon MB, Thourani VH, Makkar R, Kodali SK, Russo M et al (2019) Transcatheter aortic-valve replacement with a balloon-expandable valve in low-risk patients. N Engl J Med 380(18):1695–1705CrossRef Mack MJ, Leon MB, Thourani VH, Makkar R, Kodali SK, Russo M et al (2019) Transcatheter aortic-valve replacement with a balloon-expandable valve in low-risk patients. N Engl J Med 380(18):1695–1705CrossRef
4.
Zurück zum Zitat Sharma SK, Rao RS, Chandra P, Goel PK, Bharadwaj P, Joseph G et al (2020) First-in-human evaluation of a novel balloon-expandable transcatheter heart valve in patients with severe symptomatic native aortic stenosis: the MyVal-1 study. EuroIntervention 16(5):421–429CrossRef Sharma SK, Rao RS, Chandra P, Goel PK, Bharadwaj P, Joseph G et al (2020) First-in-human evaluation of a novel balloon-expandable transcatheter heart valve in patients with severe symptomatic native aortic stenosis: the MyVal-1 study. EuroIntervention 16(5):421–429CrossRef
5.
Zurück zum Zitat Ad N, Holmes SD, Patel J, Pritchard G, Shuman DJ, Halpin L (2016) Comparison of EuroSCORE II, original EuroSCORE, and the Society of Thoracic Surgeons risk score in cardiac surgery patients. Ann Thorac Surg 102(2):573–579CrossRef Ad N, Holmes SD, Patel J, Pritchard G, Shuman DJ, Halpin L (2016) Comparison of EuroSCORE II, original EuroSCORE, and the Society of Thoracic Surgeons risk score in cardiac surgery patients. Ann Thorac Surg 102(2):573–579CrossRef
6.
Zurück zum Zitat Mitchell C, Rahko PS, Blauwet LA, Canaday B, Finstuen JA, Foster MC et al (2019) Guidelines for performing a comprehensive transthoracic echocardiographic examination in adults: recommendations from the American Society of Echocardiography. J Am Soc Echocardiogr 32(1):1–64CrossRef Mitchell C, Rahko PS, Blauwet LA, Canaday B, Finstuen JA, Foster MC et al (2019) Guidelines for performing a comprehensive transthoracic echocardiographic examination in adults: recommendations from the American Society of Echocardiography. J Am Soc Echocardiogr 32(1):1–64CrossRef
7.
Zurück zum Zitat Kappetein AP, Head SJ, Généreux P, Piazza N, van Mieghem NM, Blackstone EH et al (2012) Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium‑2 consensus document. Eur Heart J 33(19):2403–2418CrossRef Kappetein AP, Head SJ, Généreux P, Piazza N, van Mieghem NM, Blackstone EH et al (2012) Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium‑2 consensus document. Eur Heart J 33(19):2403–2418CrossRef
8.
Zurück zum Zitat Popma JJ, Deeb GM, Yakubov SJ, Mumtaz M, Gada H, O’Hair D et al (2019) Transcatheter aortic-valve replacement with a self-expanding valve in low-risk patients. N Engl J Med 380(18):1706–1715CrossRef Popma JJ, Deeb GM, Yakubov SJ, Mumtaz M, Gada H, O’Hair D et al (2019) Transcatheter aortic-valve replacement with a self-expanding valve in low-risk patients. N Engl J Med 380(18):1706–1715CrossRef
9.
Zurück zum Zitat Généreux P, Head SJ, Van Mieghem NM, Kodali S, Kirtane AJ, Xu K et al (2012) Clinical outcomes after transcatheter aortic valve replacement using valve academic research consortium definitions: a weighted meta-analysis of 3,519 patients from 16 studies. J Am Coll Cardiol 59(25):2317–2326CrossRef Généreux P, Head SJ, Van Mieghem NM, Kodali S, Kirtane AJ, Xu K et al (2012) Clinical outcomes after transcatheter aortic valve replacement using valve academic research consortium definitions: a weighted meta-analysis of 3,519 patients from 16 studies. J Am Coll Cardiol 59(25):2317–2326CrossRef
10.
Zurück zum Zitat Carroll JD, Vemulapalli S, Dai D, Matsouaka R, Blackstone E, Edwards F et al (2017) Procedural experience for transcatheter aortic valve replacement and relation to outcomes: the STS/ACC TVT registry. J Am Coll Cardiol 70(1):29–41CrossRef Carroll JD, Vemulapalli S, Dai D, Matsouaka R, Blackstone E, Edwards F et al (2017) Procedural experience for transcatheter aortic valve replacement and relation to outcomes: the STS/ACC TVT registry. J Am Coll Cardiol 70(1):29–41CrossRef
11.
Zurück zum Zitat Berti S, Bedogni F, Giordano A, Petronio AS, Iadanza A, Bartorelli AL et al (2020) Efficacy and safety of ProGlide versus Prostar XL vascular closure devices in transcatheter aortic valve replacement: the RISPEVA registry. J Am Heart Assoc 9(21):e18042CrossRef Berti S, Bedogni F, Giordano A, Petronio AS, Iadanza A, Bartorelli AL et al (2020) Efficacy and safety of ProGlide versus Prostar XL vascular closure devices in transcatheter aortic valve replacement: the RISPEVA registry. J Am Heart Assoc 9(21):e18042CrossRef
12.
Zurück zum Zitat Jilaihawi H (2016) Paravalvular regurgitation after transcatheter aortic valve replacement: striving to perfect its prognostic evaluation with hemodynamic data. JACC Cardiovasc Interv 9(7):712–714CrossRef Jilaihawi H (2016) Paravalvular regurgitation after transcatheter aortic valve replacement: striving to perfect its prognostic evaluation with hemodynamic data. JACC Cardiovasc Interv 9(7):712–714CrossRef
13.
Zurück zum Zitat Mack MJ, Leon MB, Smith CR, Miller DC, Moses JW, Tuzcu EM et al (2015) 5‑year outcomes of transcatheter aortic valve replacement or surgical aortic valve replacement for high surgical risk patients with aortic stenosis (PARTNER 1): a randomised controlled trial. Lancet 385(9986):2477–2484CrossRef Mack MJ, Leon MB, Smith CR, Miller DC, Moses JW, Tuzcu EM et al (2015) 5‑year outcomes of transcatheter aortic valve replacement or surgical aortic valve replacement for high surgical risk patients with aortic stenosis (PARTNER 1): a randomised controlled trial. Lancet 385(9986):2477–2484CrossRef
14.
Zurück zum Zitat Sawaya FJ, Spaziano M, Lefèvre T, Roy A, Garot P, Hovasse T et al (2016) Comparison between the SAPIEN S3 and the SAPIEN XT transcatheter heart valves: a single-center experience. World J Cardiol 8(12):735–745CrossRef Sawaya FJ, Spaziano M, Lefèvre T, Roy A, Garot P, Hovasse T et al (2016) Comparison between the SAPIEN S3 and the SAPIEN XT transcatheter heart valves: a single-center experience. World J Cardiol 8(12):735–745CrossRef
15.
Zurück zum Zitat Duran Karaduman B, Ayhan H, Keleş T, Bozkurt E (2020) Evaluation of procedural and clinical outcomes of transcatheter aortic valve implantation: a single-center experience. Anatol J Cardiol 23(5):288–296PubMed Duran Karaduman B, Ayhan H, Keleş T, Bozkurt E (2020) Evaluation of procedural and clinical outcomes of transcatheter aortic valve implantation: a single-center experience. Anatol J Cardiol 23(5):288–296PubMed
16.
Zurück zum Zitat Pibarot P, Salaun E, Dahou A, Avenatti E, Guzzetti E, Annabi MS et al (2020) Echocardiographic results of transcatheter versus surgical aortic valve replacement in low-risk patients: the PARTNER 3 trial. Circulation 141(19):1527–1537CrossRef Pibarot P, Salaun E, Dahou A, Avenatti E, Guzzetti E, Annabi MS et al (2020) Echocardiographic results of transcatheter versus surgical aortic valve replacement in low-risk patients: the PARTNER 3 trial. Circulation 141(19):1527–1537CrossRef
17.
Zurück zum Zitat Sharma SK, Rao RS, Chopra M, Sonawane A, Jose J, Sengottuvelu G (2021) Myval transcatheter heart valve system in the treatment of severe symptomatic aortic stenosis. Future Cardiol 17(1):73–80CrossRef Sharma SK, Rao RS, Chopra M, Sonawane A, Jose J, Sengottuvelu G (2021) Myval transcatheter heart valve system in the treatment of severe symptomatic aortic stenosis. Future Cardiol 17(1):73–80CrossRef
Metadaten
Titel
First experiences with a new balloon-expandable Myval transcatheter aortic valve: a preliminary study
verfasst von
Ali Rıza Akyüz, M.D
Ali Hakan Konuş, M.D
Ömer Faruk Çırakoğlu, M.D
Sinan Şahin
Selim Kul, M.D
Levent Korkmaz, M.D
Publikationsdatum
13.10.2021
Verlag
Springer Medizin
Erschienen in
Herz / Ausgabe 5/2022
Print ISSN: 0340-9937
Elektronische ISSN: 1615-6692
DOI
https://doi.org/10.1007/s00059-021-05069-4

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