Skip to main content
Top

Open Access 06-09-2024 | Aortic Valve Replacement | Original Article

Hemodynamic effect of supra-annular implantation of SAPIEN 3 balloon expandable valve

Authors: Masakazu Yasuda, Kazuki Mizutani, Kyohei Onishi, Naoko Onishi, Kosuke Fujita, Masafumi Ueno, Atsushi Okamura, Yoshitaka Iwanaga, Genichi Sakaguchi, Gaku Nakazawa

Published in: Cardiovascular Intervention and Therapeutics

Login to get access

Abstract

The hemodynamic impact of the implantation depth for balloon-expandable valves is under-investigated, especially with higher implantation techniques. We assessed the hemodynamic performance of supra-annular SAPIEN 3 valve implantation. This retrospective study involved consecutive patients who underwent transcatheter aortic valve replacement (TAVR) using the SAPIEN 3. The device implantation depth and transcatheter heart valve (THV) leaflet-nadir position were angiographically analyzed, and supra-annular implantation was defined as a higher leaflet-nadir position than the original annular line. The Doppler hemodynamic status was evaluated at patient discharge. Among 184 patients, 120 (65%) underwent supra-annular implantation, and their mean implantation depth was significantly lower than that of intra-annular implantation (1.1 vs. 5.2 mm, p < 0.001). No patients developed valve embolization or coronary occlusion, and none required the TAV-in-TAV procedure. Two (1.6%) patients in the supra-annular implantation group had a mild or greater paravalvular leak. Echocardiography demonstrated that supra-annular implantation had better hemodynamic performance, showing a larger indexed effective orifice area (iEOA) compared with intra-annular implantation (1.09 vs. 0.97 cm2/m2, p < 0.01). There was a weak but negative correlation between the implantation depth and iEOA (r =  − 0.27, p < 0.01). Moderate or severe prosthesis–patient mismatch (PPM) was found in 35.9% of the intra-annular group and 9.2% of supra-annular of the supra-annular group (p < 0.01). In the multivariable analysis, supra-annular implantation was an independent predictor of better THV function (iEOA > 0.85). Supra-annular SAPIEN 3 implantation provides beneficial hemodynamic effects and reduces the PPM risk.

Graphical abstract

Appendix
Available only for authorised users
Literature
1.
go back to reference Mack MJ, Leon MB, Thourani VH, Makkar R, Kodali SK, Russo M, et al. Transcatheter aortic-valve replacement with a balloon-expandable valve in low-risk patients. N Engl J Med. 2019;380:1695–705.CrossRefPubMed Mack MJ, Leon MB, Thourani VH, Makkar R, Kodali SK, Russo M, et al. Transcatheter aortic-valve replacement with a balloon-expandable valve in low-risk patients. N Engl J Med. 2019;380:1695–705.CrossRefPubMed
2.
go back to reference Popma JJ, Deeb GM, Yakubov SJ, Mumtaz M, Gada H, O’Hair D, et al. Transcatheter aortic-valve replacement with a self-expanding valve in low-risk patients. N Engl J Med. 2019;380:1706–15.CrossRefPubMed Popma JJ, Deeb GM, Yakubov SJ, Mumtaz M, Gada H, O’Hair D, et al. Transcatheter aortic-valve replacement with a self-expanding valve in low-risk patients. N Engl J Med. 2019;380:1706–15.CrossRefPubMed
3.
go back to reference Takeji Y, Taniguchi T, Morimoto T, Shirai S, Kitai T, Tabata H, et al. In-hospital outcomes after SAVR or TAVI in patients with severe aortic stenosis. Cardiovasc Interv Ther. 2024;39:65–73.CrossRefPubMed Takeji Y, Taniguchi T, Morimoto T, Shirai S, Kitai T, Tabata H, et al. In-hospital outcomes after SAVR or TAVI in patients with severe aortic stenosis. Cardiovasc Interv Ther. 2024;39:65–73.CrossRefPubMed
4.
go back to reference Nijhoff F, Abawi M, Agostoni P, Ramjankhan FZ, Doevendans PA, Stella PR. Transcatheter aortic valve implantation with the new balloon-expandable Sapien 3 versus Sapien XT valve system: a propensity score-matched single-center comparison. Circ Cardiovasc Interv. 2015;8: e002408.CrossRefPubMed Nijhoff F, Abawi M, Agostoni P, Ramjankhan FZ, Doevendans PA, Stella PR. Transcatheter aortic valve implantation with the new balloon-expandable Sapien 3 versus Sapien XT valve system: a propensity score-matched single-center comparison. Circ Cardiovasc Interv. 2015;8: e002408.CrossRefPubMed
5.
go back to reference Winter MP, Bartko P, Hofer F, Zbiral M, Burger A, Ghanim B, et al. Evolution of outcome and complications in TAVR: a meta-analysis of observational and randomized studies. Sci Rep. 2020;10:15568.CrossRefPubMedPubMedCentral Winter MP, Bartko P, Hofer F, Zbiral M, Burger A, Ghanim B, et al. Evolution of outcome and complications in TAVR: a meta-analysis of observational and randomized studies. Sci Rep. 2020;10:15568.CrossRefPubMedPubMedCentral
6.
go back to reference Okuno T, Khan F, Asami M, Praz F, Heg D, Winkel MG, et al. Prosthesis-patient mismatch following transcatheter aortic valve replacement with supra-annular and intra-annular prostheses. JACC Cardiovasc Interv. 2019;12:2173–82.CrossRefPubMed Okuno T, Khan F, Asami M, Praz F, Heg D, Winkel MG, et al. Prosthesis-patient mismatch following transcatheter aortic valve replacement with supra-annular and intra-annular prostheses. JACC Cardiovasc Interv. 2019;12:2173–82.CrossRefPubMed
7.
go back to reference Mauri V, Kim WK, Abumayyaleh M, Walther T, Moellmann H, Schaefer U, et al. Short-term outcome and hemodynamic performance of next-generation self-expanding versus balloon-expandable transcatheter aortic valves in patients with small aortic annulus: a multicenter propensity-matched comparison. Circ Cardiovasc Interv. 2017;10:e005013.CrossRefPubMed Mauri V, Kim WK, Abumayyaleh M, Walther T, Moellmann H, Schaefer U, et al. Short-term outcome and hemodynamic performance of next-generation self-expanding versus balloon-expandable transcatheter aortic valves in patients with small aortic annulus: a multicenter propensity-matched comparison. Circ Cardiovasc Interv. 2017;10:e005013.CrossRefPubMed
8.
go back to reference Herrmann HC, Mehran R, Blackman DJ, Bailey S, Möllmann H, Abdel-Wahab M, et al. Self-expanding or balloon-expandable TAVR in patients with a small aortic annulus. New England J Med. 2024;21:1959–71.CrossRef Herrmann HC, Mehran R, Blackman DJ, Bailey S, Möllmann H, Abdel-Wahab M, et al. Self-expanding or balloon-expandable TAVR in patients with a small aortic annulus. New England J Med. 2024;21:1959–71.CrossRef
9.
go back to reference Veulemans V, Maier O, Zeus T. Factors influencing implantation depth during transcatheter aortic valve replacement. Interv Cardiol. 2024;19(e01):2024. Veulemans V, Maier O, Zeus T. Factors influencing implantation depth during transcatheter aortic valve replacement. Interv Cardiol. 2024;19(e01):2024.
10.
go back to reference Mauri V, Reimann A, Stern D, Scherner M, Kuhn E, Rudolph V, et al. Predictors of permanent pacemaker implantation after transcatheter aortic valve replacement with the SAPIEN 3. JACC Cardiovasc Interv. 2016;9:2200–9.CrossRefPubMed Mauri V, Reimann A, Stern D, Scherner M, Kuhn E, Rudolph V, et al. Predictors of permanent pacemaker implantation after transcatheter aortic valve replacement with the SAPIEN 3. JACC Cardiovasc Interv. 2016;9:2200–9.CrossRefPubMed
11.
go back to reference Ishizu K, Shirai S, Kawaguchi T, Taniguchi T, Hayashi M, Isotani A, et al. Effect of radiolucent line-guided balloon-expandable transcatheter aortic valve implantation on subsequent pacemaker rate. Am J Cardiol. 2022;165:72–80.CrossRefPubMed Ishizu K, Shirai S, Kawaguchi T, Taniguchi T, Hayashi M, Isotani A, et al. Effect of radiolucent line-guided balloon-expandable transcatheter aortic valve implantation on subsequent pacemaker rate. Am J Cardiol. 2022;165:72–80.CrossRefPubMed
12.
go back to reference Sammour Y, Banerjee K, Kumar A, Lak H, Chawla S, Incognito C, et al. Systematic approach to high implantation of SAPIEN-3 valve achieves a lower rate of conduction abnormalities including pacemaker implantation. Circu Cardiovasc Interv. 2021;14:9407. Sammour Y, Banerjee K, Kumar A, Lak H, Chawla S, Incognito C, et al. Systematic approach to high implantation of SAPIEN-3 valve achieves a lower rate of conduction abnormalities including pacemaker implantation. Circu Cardiovasc Interv. 2021;14:9407.
13.
go back to reference Kim WK, Renker M, Doerr O, Hofmann S, Nef H, Choi YH, et al. Impact of implantation depth on outcomes of new-generation balloon-expandable transcatheter heart valves. Clin Res Cardiol : Off J German Cardiac Soc. 2021;110:1983–92.CrossRef Kim WK, Renker M, Doerr O, Hofmann S, Nef H, Choi YH, et al. Impact of implantation depth on outcomes of new-generation balloon-expandable transcatheter heart valves. Clin Res Cardiol : Off J German Cardiac Soc. 2021;110:1983–92.CrossRef
14.
go back to reference Ramanathan PK, Nazir S, Elzanaty AM, Nesheiwat Z, Mahmood M, Rachwal W, et al. Novel method for implantation of balloon expandable transcatheter aortic valve replacement to reduce pacemaker rate—line of lucency method. Struct Heart. 2020;4:427–32.CrossRef Ramanathan PK, Nazir S, Elzanaty AM, Nesheiwat Z, Mahmood M, Rachwal W, et al. Novel method for implantation of balloon expandable transcatheter aortic valve replacement to reduce pacemaker rate—line of lucency method. Struct Heart. 2020;4:427–32.CrossRef
15.
go back to reference Zoghbi WA, Jone PN, Chamsi-Pasha MA, Chen T, Collins KA, Desai MY, et al. Guidelines for the evaluation of prosthetic valve function with cardiovascular imaging: a report from the american society of echocardiography developed in collaboration with the society for cardiovascular magnetic resonance and the society of cardiovascular computed tomography. J Am Soc Echocardiogr. 2024;37:2–63.CrossRefPubMed Zoghbi WA, Jone PN, Chamsi-Pasha MA, Chen T, Collins KA, Desai MY, et al. Guidelines for the evaluation of prosthetic valve function with cardiovascular imaging: a report from the american society of echocardiography developed in collaboration with the society for cardiovascular magnetic resonance and the society of cardiovascular computed tomography. J Am Soc Echocardiogr. 2024;37:2–63.CrossRefPubMed
16.
go back to reference Lancellotti P, Pibarot P, Chambers J, Edvardsen T, Delgado V, Dulgheru R, et al. Recommendations for the imaging assessment of prosthetic heart valves: a report from the european association of cardiovascular imaging endorsed by the chinese society of echocardiography, the inter-american society of echocardiography, and the brazilian department of cardiovascular imaging. Eur Heart J Cardiovasc Imaging. 2016;17:589–90.CrossRefPubMed Lancellotti P, Pibarot P, Chambers J, Edvardsen T, Delgado V, Dulgheru R, et al. Recommendations for the imaging assessment of prosthetic heart valves: a report from the european association of cardiovascular imaging endorsed by the chinese society of echocardiography, the inter-american society of echocardiography, and the brazilian department of cardiovascular imaging. Eur Heart J Cardiovasc Imaging. 2016;17:589–90.CrossRefPubMed
17.
go back to reference Hahn RT, Douglas PS, Jaber WA, Leipsic J, Kapadia S, Thourani VH, et al. Doppler velocity index outcomes following surgical or transcatheter aortic valve replacement in the PARTNER trials. JACC Cardiovasc Interv. 2021;14:1594–606.CrossRefPubMed Hahn RT, Douglas PS, Jaber WA, Leipsic J, Kapadia S, Thourani VH, et al. Doppler velocity index outcomes following surgical or transcatheter aortic valve replacement in the PARTNER trials. JACC Cardiovasc Interv. 2021;14:1594–606.CrossRefPubMed
18.
go back to reference Généreux P, Piazza N, Alu MC, Nazif T, Hahn RT, Pibarot P, et al. Valve academic research consortium 3: updated endpoint definitions for aortic valve clinical research. J Am Coll Cardiol. 2021;77:2717–46.CrossRefPubMed Généreux P, Piazza N, Alu MC, Nazif T, Hahn RT, Pibarot P, et al. Valve academic research consortium 3: updated endpoint definitions for aortic valve clinical research. J Am Coll Cardiol. 2021;77:2717–46.CrossRefPubMed
19.
go back to reference Ochiai T, Yamanaka F, Shishido K, Moriyama N, Komatsu I, Yokoyama H, et al. Impact of high implantation of transcatheter aortic valve on subsequent conduction disturbances and coronary access. JACC Cardiovasc Interv. 2023;16:1192–204.CrossRefPubMed Ochiai T, Yamanaka F, Shishido K, Moriyama N, Komatsu I, Yokoyama H, et al. Impact of high implantation of transcatheter aortic valve on subsequent conduction disturbances and coronary access. JACC Cardiovasc Interv. 2023;16:1192–204.CrossRefPubMed
20.
go back to reference Simonato M, Azadani AN, Webb J, Leipsic J, Kornowski R, Vahanian A, et al. In vitro evaluation of implantation depth in valve-in-valve using different transcatheter heart valves. EuroIntervention. 2016;12:909–17.CrossRefPubMed Simonato M, Azadani AN, Webb J, Leipsic J, Kornowski R, Vahanian A, et al. In vitro evaluation of implantation depth in valve-in-valve using different transcatheter heart valves. EuroIntervention. 2016;12:909–17.CrossRefPubMed
21.
go back to reference Kawaguchi T, Yamaji K, Ishizu K, Morinaga T, Hayashi M, Isotani A, et al. Effect of postdilatation following balloon expandable transcatheter aortic valve implantation. Catheter Cardiovasc Interv. 2020;96:E630-e639.CrossRefPubMed Kawaguchi T, Yamaji K, Ishizu K, Morinaga T, Hayashi M, Isotani A, et al. Effect of postdilatation following balloon expandable transcatheter aortic valve implantation. Catheter Cardiovasc Interv. 2020;96:E630-e639.CrossRefPubMed
22.
go back to reference Nara Y, Watanabe Y, Kataoka A, Nakashima M, Hioki H, Kawashima H, et al. Balloon post-dilatation improves long-term valve performance after balloon-expandable valve implantation. Cardiovasc Revas Med. 2022;37:15–22.CrossRef Nara Y, Watanabe Y, Kataoka A, Nakashima M, Hioki H, Kawashima H, et al. Balloon post-dilatation improves long-term valve performance after balloon-expandable valve implantation. Cardiovasc Revas Med. 2022;37:15–22.CrossRef
23.
go back to reference León Del Pino MDC, Ruíz Ortiz M, Delgado Ortega M, Sánchez Fernández J, Ferreiro Quero C, Durán Jiménez E, et al. Prosthesis-patient mismatch after transcatheter aortic valve replacement: prevalence and medium term prognostic impact. Int J Cardiovasc Imaging. 2019;35:827–36.CrossRefPubMed León Del Pino MDC, Ruíz Ortiz M, Delgado Ortega M, Sánchez Fernández J, Ferreiro Quero C, Durán Jiménez E, et al. Prosthesis-patient mismatch after transcatheter aortic valve replacement: prevalence and medium term prognostic impact. Int J Cardiovasc Imaging. 2019;35:827–36.CrossRefPubMed
24.
go back to reference Zorn GL 3rd, Little SH, Tadros P, Deeb GM, Gleason TG, Heiser J, et al. Prosthesis-patient mismatch in high-risk patients with severe aortic stenosis: a randomized trial of a self-expanding prosthesis. J Thorac Cardiovasc Surg. 2016;151(1014–1022):1023.e1011-1013. Zorn GL 3rd, Little SH, Tadros P, Deeb GM, Gleason TG, Heiser J, et al. Prosthesis-patient mismatch in high-risk patients with severe aortic stenosis: a randomized trial of a self-expanding prosthesis. J Thorac Cardiovasc Surg. 2016;151(1014–1022):1023.e1011-1013.
25.
go back to reference Miyasaka M, Tada N, Taguri M, Kato S, Enta Y, Otomo T, et al. Incidence, predictors, and clinical impact of prosthesis-patient mismatch following transcatheter aortic valve replacement in asian patients: the OCEAN-TAVI registry. JACC Cardiovasc Interv. 2018;11:771–80.CrossRefPubMed Miyasaka M, Tada N, Taguri M, Kato S, Enta Y, Otomo T, et al. Incidence, predictors, and clinical impact of prosthesis-patient mismatch following transcatheter aortic valve replacement in asian patients: the OCEAN-TAVI registry. JACC Cardiovasc Interv. 2018;11:771–80.CrossRefPubMed
26.
go back to reference Hahn RT, Leipsic J, Douglas PS, Jaber WA, Weissman NJ, Pibarot P, et al. Comprehensive echocardiographic assessment of normal transcatheter valve function. JACC Cardiovasc Imaging. 2019;12:25–34.CrossRefPubMed Hahn RT, Leipsic J, Douglas PS, Jaber WA, Weissman NJ, Pibarot P, et al. Comprehensive echocardiographic assessment of normal transcatheter valve function. JACC Cardiovasc Imaging. 2019;12:25–34.CrossRefPubMed
Metadata
Title
Hemodynamic effect of supra-annular implantation of SAPIEN 3 balloon expandable valve
Authors
Masakazu Yasuda
Kazuki Mizutani
Kyohei Onishi
Naoko Onishi
Kosuke Fujita
Masafumi Ueno
Atsushi Okamura
Yoshitaka Iwanaga
Genichi Sakaguchi
Gaku Nakazawa
Publication date
06-09-2024
Publisher
Springer Nature Singapore
Published in
Cardiovascular Intervention and Therapeutics
Print ISSN: 1868-4300
Electronic ISSN: 1868-4297
DOI
https://doi.org/10.1007/s12928-024-01040-2

A quick guide to ECGs

Improve your ECG interpretation skills with this comprehensive, rapid, interactive course. Expert advice provides detailed feedback as you work through 50 ECGs covering the most common cardiac presentations to ensure your practice stays up to date. 

PD Dr. Carsten W. Israel
Developed by: Springer Medizin
Start the cases

Keynote webinar | Spotlight on medication adherence

  • Webinar | 27-06-2024 | 18:00 (CEST)

Medication non-adherence is a major barrier to effective healthcare delivery; half of all patients do not follow their doctor’s recommendations or treatment plan.

Our experts explain the fundamentals with a practical discussion of how to manage non-adherence in two common scenarios: hypertension and asthma control.

Prof. Kevin Dolgin
Prof. Florian Limbourg
Prof. Anoop Chauhan
Developed by: Springer Medicine
Watch now