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Erschienen in: Cardiovascular Intervention and Therapeutics 4/2018

28.11.2017 | Original Article

Efficacy and safety of transcatheter aortic valve implantation with Edwards SAPIEN 3 and XT in smaller Asian anatomy

verfasst von: Makoto Nakashima, Yusuke Watanabe, Hirofumi Hioki, Yugo Nara, Fukuko Nagura, Naoyoshi Hosogoe, Hideyuki Kawashima, Akihisa Kataoka, Shuji Otsuki, Kumiko Konno, Hiroyuki Kyono, Naoyuki Yokoyama, Ken Kozuma

Erschienen in: Cardiovascular Intervention and Therapeutics | Ausgabe 4/2018

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Abstract

We aimed to compare the efficacy and safety of transcatheter aortic valve implantation (TAVI) using Edwards SAPIEN 3 (S3) valve and SAPIEN XT) in smaller anatomy. The new generation S3 TAVI device has been used worldwide; however, its efficacy and safety in smaller Asian anatomy remain unknown. Between February 2014 and March 2017, 166 consecutive patients (S3, 54; XT, 112) were treated with balloon-expandable TAVI in a single center and their outcomes were analyzed. Median patient age was 85 (range: 81–88) years and mean body surface area was 1.41 ± 0.15 m2. A 23-mm size valve was used in S3 and XT groups (70 vs. 62%, p = 0.224). The transfemoral approach was more frequently used in the S3 than in the XT group (96 vs. 72%, p < 0.001). Although, the minimal luminal diameter of the femoral artery was smaller in the S3 group (5.9 vs. 6.4 mm, p = 0.001), the rates of major (2 vs. 11%, p = 0.226) and minor (11 vs. 5%, p = 0.107) vascular complications did not increase. The frequency of paravalvular leaks (PVL) ≥ 2 was significantly reduced in the S3 group (11 vs. 61%, p < 0.001); however, pre- (24 vs. 91%, p < 0.001) and post- (4 vs. 19%, p < 0.001) dilatations were less frequently performed. Pacemaker implantation incidence did not increase (4 vs. 5%, p = 1.0) and peak velocity of the transcatheter heart valve was significantly higher in the S3 group (2.3 vs. 2.2 m/s, p = 0.046). Device success was high (89 vs. 93%, p = 0.387) while the 30-day all-cause mortality was low (2 vs. 1%, p = 0.583) in both groups. TAVI with the S3 device was safe and effective, with low incidence of vascular complications and reduced PVL, in smaller body-sized Asians.
Literatur
1.
Zurück zum Zitat Ducrocq G, Francis F, Serfaty JM, Himbert D, Maury JM, Pasi N, et al. Vascular complications of transfemoral aortic valve implantation with the Edwards SAPIEN prosthesis: incidence and impact on outcome. EuroIntervention. 2010;5:666–72.CrossRef Ducrocq G, Francis F, Serfaty JM, Himbert D, Maury JM, Pasi N, et al. Vascular complications of transfemoral aortic valve implantation with the Edwards SAPIEN prosthesis: incidence and impact on outcome. EuroIntervention. 2010;5:666–72.CrossRef
2.
Zurück zum Zitat Tamburino C, Capodanno D, Ramondo A, Petronio AS, Ettori F, Santoro G, et al. Incidence and predictors of early and late mortality after transcatheter aortic valve implantation in 663 patients with severe aortic stenosis. Circulation. 2011;123:299–308.CrossRef Tamburino C, Capodanno D, Ramondo A, Petronio AS, Ettori F, Santoro G, et al. Incidence and predictors of early and late mortality after transcatheter aortic valve implantation in 663 patients with severe aortic stenosis. Circulation. 2011;123:299–308.CrossRef
3.
Zurück zum Zitat Cerrato E, Nombela-Franco L, Nazif TM, Eltchaninoff H, Søndergaard L, Ribeiro HB, et al. Evaluation of current practices in transcatheter aortic valve implantation: the WRITTEN (WoRldwIde TAVI ExperieNce) survey. Int J Cardiol. 2017;228:640–7.CrossRef Cerrato E, Nombela-Franco L, Nazif TM, Eltchaninoff H, Søndergaard L, Ribeiro HB, et al. Evaluation of current practices in transcatheter aortic valve implantation: the WRITTEN (WoRldwIde TAVI ExperieNce) survey. Int J Cardiol. 2017;228:640–7.CrossRef
4.
Zurück zum Zitat Watanabe Y, Hayashida K, Lefevre T, Chevalier B, Hovasse T, Romano M, et al. Transcatheter aortic valve implantation in patients of small body size. Catheter Cardiovasc Interv. 2014;84:272–80.CrossRef Watanabe Y, Hayashida K, Lefevre T, Chevalier B, Hovasse T, Romano M, et al. Transcatheter aortic valve implantation in patients of small body size. Catheter Cardiovasc Interv. 2014;84:272–80.CrossRef
5.
Zurück zum Zitat Watanabe Y, Hayashida K, Takayama M, Mitsudo K, Nanto S, Takanashi S, et al. First direct comparison of clinical outcomes between European and Asian cohorts in transcatheter aortic valve implantation: the Massy study group vs. the PREVAIL JAPAN trial. J Cardiol. 2015;65:112–6.CrossRef Watanabe Y, Hayashida K, Takayama M, Mitsudo K, Nanto S, Takanashi S, et al. First direct comparison of clinical outcomes between European and Asian cohorts in transcatheter aortic valve implantation: the Massy study group vs. the PREVAIL JAPAN trial. J Cardiol. 2015;65:112–6.CrossRef
6.
Zurück zum Zitat Yoon SH, Ohno Y, Araki M, Barbanti M, Lin MS, Ahn JM, et al. Comparison of aortic root anatomy and calcification distribution between Asian and Caucasian patients who underwent transcatheter aortic valve implantation. Am J Cardiol. 2015;116:1566–73.CrossRef Yoon SH, Ohno Y, Araki M, Barbanti M, Lin MS, Ahn JM, et al. Comparison of aortic root anatomy and calcification distribution between Asian and Caucasian patients who underwent transcatheter aortic valve implantation. Am J Cardiol. 2015;116:1566–73.CrossRef
7.
Zurück zum Zitat Hayashida K, Bouvier E, Lefevre T, Hovasse T, Morice MC, Chevalier B, et al. Impact of CT-guided valve sizing on post-procedural aortic regurgitation in transcatheter aortic valve implantation. EuroIntervention. 2012;8:546–55.CrossRef Hayashida K, Bouvier E, Lefevre T, Hovasse T, Morice MC, Chevalier B, et al. Impact of CT-guided valve sizing on post-procedural aortic regurgitation in transcatheter aortic valve implantation. EuroIntervention. 2012;8:546–55.CrossRef
8.
Zurück zum Zitat Jilaihawi H, Kashif M, Fontana G, Furugen A, Shiota T, Friede G, et al. Cross-sectional computed tomographic assessment improves accuracy of aortic annular sizing for transcatheter aortic valve replacement and reduces the incidence of paravalvular aortic regurgitation. J Am Coll Cardiol. 2012;59:1275–86.CrossRef Jilaihawi H, Kashif M, Fontana G, Furugen A, Shiota T, Friede G, et al. Cross-sectional computed tomographic assessment improves accuracy of aortic annular sizing for transcatheter aortic valve replacement and reduces the incidence of paravalvular aortic regurgitation. J Am Coll Cardiol. 2012;59:1275–86.CrossRef
9.
Zurück zum Zitat Kappetein AP, Head SJ, Genereux P, Piazza N, van Mieghem NM, Blackstone EH, et al. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document. J Am Coll Cardiol. 2012;60:1438–54.CrossRef Kappetein AP, Head SJ, Genereux P, Piazza N, van Mieghem NM, Blackstone EH, et al. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document. J Am Coll Cardiol. 2012;60:1438–54.CrossRef
10.
Zurück zum Zitat Pibarot P, Dumesnil JG. Hemodynamic and clinical impact of prosthesis-patient mismatch in the aortic valve position and its prevention. J Am Coll Cardiol. 2000;36:1131–41.CrossRef Pibarot P, Dumesnil JG. Hemodynamic and clinical impact of prosthesis-patient mismatch in the aortic valve position and its prevention. J Am Coll Cardiol. 2000;36:1131–41.CrossRef
11.
Zurück zum Zitat Arai T, Lefevre T, Hovasse T, Morice MC, Garot P, Benamer H, et al. Comparison of Edwards SAPIEN 3 versus SAPIEN XT in transfemoral transcatheter aortic valve implantation: difference of valve selection in the real world. J Cardiol. 2017;69:565–9.CrossRef Arai T, Lefevre T, Hovasse T, Morice MC, Garot P, Benamer H, et al. Comparison of Edwards SAPIEN 3 versus SAPIEN XT in transfemoral transcatheter aortic valve implantation: difference of valve selection in the real world. J Cardiol. 2017;69:565–9.CrossRef
12.
Zurück zum Zitat Hayashida K, Lefevre T, Chevalier B, Hovasse T, Romano M, Garot P, et al. Transfemoral aortic valve implantation new criteria to predict vascular complications. JACC Cardiovasc Interv. 2011;4:851–8.CrossRef Hayashida K, Lefevre T, Chevalier B, Hovasse T, Romano M, Garot P, et al. Transfemoral aortic valve implantation new criteria to predict vascular complications. JACC Cardiovasc Interv. 2011;4:851–8.CrossRef
13.
Zurück zum Zitat Moreno R, Calvo L, Salinas P, Dobarro D, Santiago JV, Sanchez-Recalde A, et al. Causes of peri-operative mortality after transcatheter aortic valve implantation: a pooled analysis of 12 studies and 1223 patients. J Invasive Cardiol. 2011;23:180–4.PubMed Moreno R, Calvo L, Salinas P, Dobarro D, Santiago JV, Sanchez-Recalde A, et al. Causes of peri-operative mortality after transcatheter aortic valve implantation: a pooled analysis of 12 studies and 1223 patients. J Invasive Cardiol. 2011;23:180–4.PubMed
14.
Zurück zum Zitat Steinvil A, Leshem-Rubinow E, Halkin A, Abramowitz Y, Ben-Assa E, Shacham Y, et al. Vascular complications after transcatheter aortic valve implantation and their association with mortality reevaluated by the valve academic research consortium definitions. Am J Cardiol. 2015;115:100–6.CrossRef Steinvil A, Leshem-Rubinow E, Halkin A, Abramowitz Y, Ben-Assa E, Shacham Y, et al. Vascular complications after transcatheter aortic valve implantation and their association with mortality reevaluated by the valve academic research consortium definitions. Am J Cardiol. 2015;115:100–6.CrossRef
15.
Zurück zum Zitat Wohrle J, Gonska B, Rodewald C, Seeger J, Scharnbeck D, Rottbauer W. Transfemoral aortic valve implantation with the new Edwards Sapien 3 valve for treatment of severe aortic stenosis—impact of valve size in a single center experience. PLoS One. 2016;11:e0151247.CrossRef Wohrle J, Gonska B, Rodewald C, Seeger J, Scharnbeck D, Rottbauer W. Transfemoral aortic valve implantation with the new Edwards Sapien 3 valve for treatment of severe aortic stenosis—impact of valve size in a single center experience. PLoS One. 2016;11:e0151247.CrossRef
16.
Zurück zum Zitat Webb J, Gerosa G, Lefevre T, Leipsic J, Spence M, Thomas M, et al. Multicenter evaluation of a next-generation balloon-expandable transcatheter aortic valve. J Am Coll Cardiol. 2014;64:2235–43.CrossRef Webb J, Gerosa G, Lefevre T, Leipsic J, Spence M, Thomas M, et al. Multicenter evaluation of a next-generation balloon-expandable transcatheter aortic valve. J Am Coll Cardiol. 2014;64:2235–43.CrossRef
17.
Zurück zum Zitat Yashima F, Yamamoto M, Tanaka M, Yanagisawa R, Arai T, Shimizu H, et al. Transcatheter aortic valve implantation in patients with an extremely small native aortic annulus: the OCEAN-TAVI registry. Int J Cardiol. 2017;240:126–31.CrossRef Yashima F, Yamamoto M, Tanaka M, Yanagisawa R, Arai T, Shimizu H, et al. Transcatheter aortic valve implantation in patients with an extremely small native aortic annulus: the OCEAN-TAVI registry. Int J Cardiol. 2017;240:126–31.CrossRef
18.
Zurück zum Zitat Gilard M, Eltchaninoff H, Iung B, Donzeau-Gouge P, Chevreul K, Fajadet J, et al. Registry of transcatheter aortic-valve implantation in high-risk patients. N Engl J Med. 2012;366:1705–15.CrossRef Gilard M, Eltchaninoff H, Iung B, Donzeau-Gouge P, Chevreul K, Fajadet J, et al. Registry of transcatheter aortic-valve implantation in high-risk patients. N Engl J Med. 2012;366:1705–15.CrossRef
19.
Zurück zum Zitat Hayashida K, Lefevre T, Chevalier B, Hovasse T, Romano M, Garot P, et al. Impact of post-procedural aortic regurgitation on mortality after transcatheter aortic valve implantation. JACC Cardiovasc Interv. 2012;5:1247–56.CrossRef Hayashida K, Lefevre T, Chevalier B, Hovasse T, Romano M, Garot P, et al. Impact of post-procedural aortic regurgitation on mortality after transcatheter aortic valve implantation. JACC Cardiovasc Interv. 2012;5:1247–56.CrossRef
20.
Zurück zum Zitat Bijuklic K, Haselbach T, Witt J, Krause K, Hansen L, Gehrckens R, et al. Increased risk of cerebral embolization after implantation of a balloon-expandable aortic valve without prior balloon valvuloplasty. JACC Cardiovasc Interv. 2015;8:1608–13.CrossRef Bijuklic K, Haselbach T, Witt J, Krause K, Hansen L, Gehrckens R, et al. Increased risk of cerebral embolization after implantation of a balloon-expandable aortic valve without prior balloon valvuloplasty. JACC Cardiovasc Interv. 2015;8:1608–13.CrossRef
21.
Zurück zum Zitat Abramowitz Y, Jilaihawi H, Chakravarty T, Maeno Y, Kawamori H, Kazuno Y, et al. Sapien 3 transcatheter aortic valve implantation with moderate or without predilation. J Invasive Cardiol. 2016;28:421–6.PubMed Abramowitz Y, Jilaihawi H, Chakravarty T, Maeno Y, Kawamori H, Kazuno Y, et al. Sapien 3 transcatheter aortic valve implantation with moderate or without predilation. J Invasive Cardiol. 2016;28:421–6.PubMed
22.
Zurück zum Zitat Barbanti M, Yang TH, Rodes Cabau J, Tamburino C, Wood DA, Jilaihawi H, et al. Anatomical and procedural features associated with aortic root rupture during balloon-expandable transcatheter aortic valve replacement. Circulation. 2013;128:244–53.CrossRef Barbanti M, Yang TH, Rodes Cabau J, Tamburino C, Wood DA, Jilaihawi H, et al. Anatomical and procedural features associated with aortic root rupture during balloon-expandable transcatheter aortic valve replacement. Circulation. 2013;128:244–53.CrossRef
23.
Zurück zum Zitat Tarantini G, Mojoli M, Purita P, Napodano M, D’Onofrio A, Frigo A, et al. Unravelling the (arte)fact of increased pacemaker rate with the Edwards SAPIEN 3 valve. EuroIntervention. 2015;11:343–50.CrossRef Tarantini G, Mojoli M, Purita P, Napodano M, D’Onofrio A, Frigo A, et al. Unravelling the (arte)fact of increased pacemaker rate with the Edwards SAPIEN 3 valve. EuroIntervention. 2015;11:343–50.CrossRef
24.
Zurück zum Zitat Head SJ, Mokhles MM, Osnabrugge RL, Pibarot P, Mack MJ, Takkenberg JJ, et al. The impact of prosthesis-patient mismatch on long-term survival after aortic valve replacement: a systematic review and meta-analysis of 34 observational studies comprising 27 186 patients with 133 141 patient-years. Eur Heart J. 2012;33:1518–29.CrossRef Head SJ, Mokhles MM, Osnabrugge RL, Pibarot P, Mack MJ, Takkenberg JJ, et al. The impact of prosthesis-patient mismatch on long-term survival after aortic valve replacement: a systematic review and meta-analysis of 34 observational studies comprising 27 186 patients with 133 141 patient-years. Eur Heart J. 2012;33:1518–29.CrossRef
25.
Zurück zum Zitat Clavel MA, Webb JG, Pibarot P, Altwegg L, Dumont E, Thompson C, et al. Comparison of the hemodynamic performance of percutaneous and surgical bioprostheses for the treatment of severe aortic stenosis. J Am Coll Cardiol. 2009;53:1883–91.CrossRef Clavel MA, Webb JG, Pibarot P, Altwegg L, Dumont E, Thompson C, et al. Comparison of the hemodynamic performance of percutaneous and surgical bioprostheses for the treatment of severe aortic stenosis. J Am Coll Cardiol. 2009;53:1883–91.CrossRef
26.
Zurück zum Zitat da Silva C, Sahlen A, Winter R, Back M, Ruck A, Settergren M, et al. Prosthesis-patient mismatch after transcatheter aortic valve implantation: impact of 2D-transthoracic echocardiography versus 3D-transesophageal echocardiography. Int J Cardiovasc Imaging. 2014;30:1549–57.CrossRef da Silva C, Sahlen A, Winter R, Back M, Ruck A, Settergren M, et al. Prosthesis-patient mismatch after transcatheter aortic valve implantation: impact of 2D-transthoracic echocardiography versus 3D-transesophageal echocardiography. Int J Cardiovasc Imaging. 2014;30:1549–57.CrossRef
27.
Zurück zum Zitat Tzikas A, Piazza N, Geleijnse ML, Van Mieghem N, Nuis RJ, Schultz C, et al. Prosthesis-patient mismatch after transcatheter aortic valve implantation with the medtronic CoreValve system in patients with aortic stenosis. Am J Cardiol. 2010;106:255–60.CrossRef Tzikas A, Piazza N, Geleijnse ML, Van Mieghem N, Nuis RJ, Schultz C, et al. Prosthesis-patient mismatch after transcatheter aortic valve implantation with the medtronic CoreValve system in patients with aortic stenosis. Am J Cardiol. 2010;106:255–60.CrossRef
28.
Zurück zum Zitat Bax JJ, Delgado V, Bapat V, Baumgartner H, Collet JP, Erbel R, et al. Open issues in transcatheter aortic valve implantation. Part 2: procedural issues and outcomes after transcatheter aortic valve implantation. Eur Heart J. 2014;35:2639–54.CrossRef Bax JJ, Delgado V, Bapat V, Baumgartner H, Collet JP, Erbel R, et al. Open issues in transcatheter aortic valve implantation. Part 2: procedural issues and outcomes after transcatheter aortic valve implantation. Eur Heart J. 2014;35:2639–54.CrossRef
Metadaten
Titel
Efficacy and safety of transcatheter aortic valve implantation with Edwards SAPIEN 3 and XT in smaller Asian anatomy
verfasst von
Makoto Nakashima
Yusuke Watanabe
Hirofumi Hioki
Yugo Nara
Fukuko Nagura
Naoyoshi Hosogoe
Hideyuki Kawashima
Akihisa Kataoka
Shuji Otsuki
Kumiko Konno
Hiroyuki Kyono
Naoyuki Yokoyama
Ken Kozuma
Publikationsdatum
28.11.2017
Verlag
Springer Japan
Erschienen in
Cardiovascular Intervention and Therapeutics / Ausgabe 4/2018
Print ISSN: 1868-4300
Elektronische ISSN: 1868-4297
DOI
https://doi.org/10.1007/s12928-017-0502-9

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