Subscribe to RSS
DOI: 10.1055/s-0040-1713168
Oversized versus Non-oversized Prosthesis: Midterm Outcomes after Transcatheter Aortic Valve Replacement Using SAPIEN 3 Valve
![](https://www.thieme-connect.de/media/thoracic/202105/lookinside/thumbnails/10-1055-s-0040-1713168_195769oc-1.jpg)
Abstract
Background A certain degree of prosthesis oversizing is recommended for the SAPIEN 3 (S3; Edwards Lifesciences Corp., Irvine, California, United States) to ensure device success. We aimed to investigate midterm outcomes in patients who received oversized (OS) S3 valve after transapical–transcatheter aortic valve replacement (TA-TAVR).
Methods Out of 122 patients with aortic stenosis who underwent TA-TAVR using S3 at our institution, 42 received OS prosthesis. We used computed tomography (CT) derived effective diameter to assess oversizing. We defined oversizing if the labeled diameter of the selected valve for implantation was ≥2 mm bigger than the effective annulus diameter calculated by the annulus area. We conducted a midterm follow-up and compared the OS cohort with the non-OS (nOS) cohort.
Results The study groups showed similar risk score and age (STS [Society of Thoracic Surgery] score: 5.4 ± 3; mean age: 80.7 ± 5.7). The 30-day mortality was 7.1% in OS versus 2.4% in nOS. The 30-day all-stroke was 2.4% in OS versus 0% in nOS. The 1- and 3-year all-cause mortality were 28.5 and 42.8% in OS versus 21.9 and 26.8% in nOS, respectively. Midterm freedom from death and from cardiocerebral events was similar in both groups. Moderate/severe paravalvular leakage occurred in 0% in OS versus 5.4% in nOS. The postdilation rate was 7.1% in OS versus 15.3% in nOS. The rate of new permanent pacemaker implantation (PPI) was 15.7% in OS versus 9.3% in nOS. The STS score was detected as an independent predictor of mortality.
Conclusion Oversizing reduces the risk of device failure and intraprocedural postdilation but increases the risk of PPI. Early and midterm morbidity and mortality after OS and nOS with S3 are comparable.
Note
Meeting presentation: This study was presented at the Annual Meeting of the German Society of Thoracic and Cardiovascular Surgery, Wiesbaden, February 18, 2019.
Publication History
Received: 15 December 2019
Accepted: 27 April 2020
Article published online:
20 July 2020
© 2021. Thieme. All rights reserved.
Georg Thieme Verlag KG
Rüdigerstraße 14, 70469 Stuttgart, Germany
-
References
- 1 Willson AB, Webb JG, Labounty TM. et al. 3-dimensional aortic annular assessment by multidetector computed tomography predicts moderate or severe paravalvular regurgitation after transcatheter aortic valve replacement: a multicenter retrospective analysis. J Am Coll Cardiol 2012; 59 (14) 1287-1294
- 2 Binder RK, Rodés-Cabau J, Wood DA. et al. Transcatheter aortic valve replacement with the SAPIEN 3: a new balloon-expandable transcatheter heart valve. JACC Cardiovasc Interv 2013; 6 (03) 293-300
- 3 Husser O, Pellegrini C, Kessler T. et al. Predictors of permanent pacemaker implantations and new-onset conduction abnormalities with the SAPIEN 3 Balloon-Expandable Transcatheter Heart Valve. JACC Cardiovasc Interv 2016; 9 (03) 244-254
- 4 Pellegrini C, Kim WK, Holzamer A. et al. Multicenter evaluation of prosthesis oversizing of the SAPIEN 3 Transcatheter Heart Valve. Impact on device failure and new pacemaker implantations. Rev Esp Cardiol (Engl Ed) 2019; 72 (08) 641-648
- 5 Kappetein AP, Head SJ, Généreux P. et al; Valve Academic Research Consortium-2. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document. J Thorac Cardiovasc Surg 2013; 145 (01) 6-23
- 6 Achenbach S, Delgado V, Hausleiter J, Schoenhagen P, Min JK, Leipsic JA. SCCT expert consensus document on computed tomography imaging before transcatheter aortic valve implantation (TAVI)/transcatheter aortic valve replacement (TAVR). J Cardiovasc Comput Tomogr 2012; 6 (06) 366-380
- 7 Blanke P, Reinöhl J, Schlensak C. et al. Prosthesis oversizing in balloon-expandable transcatheter aortic valve implantation is associated with contained rupture of the aortic root. Circ Cardiovasc Interv 2012; 5 (04) 540-548
- 8 Leber AW, Eichinger W, Rieber J. et al. MSCT guided sizing of the Edwards SAPIEN XT TAVI device: impact of different degrees of oversizing on clinical outcome. Int J Cardiol 2013; 168 (03) 2658-2664
- 9 Yang TH, Webb JG, Blanke P. et al. Incidence and severity of paravalvular aortic regurgitation with multidetector computed tomography nominal area oversizing or undersizing after transcatheter heart valve replacement with the SAPIEN 3: a comparison with the SAPIEN XT. JACC Cardiovasc Interv 2015; 8 (03) 462-471
- 10 Regueiro A, Linke A, Latib A. et al. Association between transcatheter aortic valve replacement and subsequent infective endocarditis and in-hospital Death. JAMA 2016; 316 (10) 1083-1092
- 11 Kodali S, Pibarot P, Douglas PS. et al. Paravalvular regurgitation after transcatheter aortic valve replacement with the Edwards SAPIEN valve in the PARTNER trial: characterizing patients and impact on outcomes. Eur Heart J 2015; 36 (07) 449-456
- 12 Terré JA, George I, Smith CR. Pros and cons of transcatheter aortic valve implantation (TAVI). Ann Cardiothorac Surg 2017; 6 (05) 444-452
- 13 Kodali SK, Williams MR, Smith CR. et al; PARTNER Trial Investigators. Two-year outcomes after transcatheter or surgical aortic-valve replacement. N Engl J Med 2012; 366 (18) 1686-1695
- 14 Vasa-Nicotera M, Sinning JM, Chin D. et al. Impact of paravalvular leakage on outcome in patients after transcatheter aortic valve implantation. JACC Cardiovasc Interv 2012; 5 (08) 858-865
- 15 Jilaihawi H, Makkar RR. Prognostic impact of aortic regurgitation after transcatheter aortic valve implantation. EuroIntervention 2012; ;8 Suppl Q: Q31-Q33
- 16 Binder RK, Webb JG, Toggweiler S. et al. Impact of post-implant SAPIEN XT geometry and position on conduction disturbances, hemodynamic performance, and paravalvular regurgitation. JACC Cardiovasc Interv 2013; 6 (05) 462-468
- 17 Herrmann HC, Thourani VH, Kodali SK. et al; PARTNER Investigators. One-year clinical outcomes with SAPIEN 3 transcatheter aortic valve replacement in high-risk and inoperable patients with severe aortic stenosis. Circulation 2016; 134 (02) 130-140
- 18 Pibarot P, Hahn RT, Weissman NJ. et al. Association of paravalvular regurgitation with 1-year outcomes after transcatheter aortic valve replacement with the SAPIEN 3 valve. JAMA Cardiol 2017; 2 (11) 1208-1216
- 19 Athappan G, Patvardhan E, Tuzcu EM. et al. Incidence, predictors, and outcomes of aortic regurgitation after transcatheter aortic valve replacement: meta-analysis and systematic review of literature. J Am Coll Cardiol 2013; 61 (15) 1585-1595
- 20 Webb J, Gerosa G, Lefèvre T. et al. Multicenter evaluation of a next-generation balloon-expandable transcatheter aortic valve. J Am Coll Cardiol 2014; 64 (21) 2235-2243
- 21 Murray MI, Geis N, Pleger ST. et al. First experience with the new generation Edwards SAPIEN 3 aortic bioprosthesis: procedural results and short term outcome. J Interv Cardiol 2015; 28 (01) 109-116
- 22 Manoharan G. Impact of technological changes on TAVI outcomes-for better, for worse or no change?. Rev Esp Cardiol (Engl Ed) 2017; 70 (09) 694-695
- 23 Siontis GC, Jüni P, Pilgrim T. et al. Predictors of permanent pacemaker implantation in patients with severe aortic stenosis undergoing TAVR: a meta-analysis. J Am Coll Cardiol 2014; 64 (02) 129-140
- 24 Maeno Y, Abramowitz Y, Kawamori H. et al. A highly predictive risk model for pacemaker implantation after TAVR. JACC Cardiovasc Imaging 2017; 10 (10 Pt A): 1139-1147
- 25 Khodaee F, Barakat M, Abbasi M, Dvir D, Azadani AN. Incomplete expansion of transcatheter aortic valves is associated with propensity for valve thrombosis. Interact Cardiovasc Thorac Surg 2020; 30 (01) 39-46
- 26 Blanke P, Pibarot P, Hahn R. et al. Computed tomography-based oversizing degrees and incidence of paravalvular regurgitation of a new generation transcatheter heart valve. JACC Cardiovasc Interv 2017; 10 (08) 810-820
- 27 Kempfert J, Van Linden A, Lehmkuhl L. et al. Aortic annulus sizing: echocardiographic versus computed tomography derived measurements in comparison with direct surgical sizing. Eur J Cardiothorac Surg 2012; 42 (04) 627-633
- 28 Reents W, Barth S, Griese DP. et al. Transfemoral versus transapical transcatheter aortic valve implantation: a single-centre experience. Eur J Cardiothorac Surg 2019; 55 (04) 744-750
- 29 Beve M, Auffret V, Belhaj Soulami R. et al. Comparison of the transarterial and transthoracic approaches in nontransfemoral transcatheter aortic valve implantation. Am J Cardiol 2019; 123 (09) 1501-1509