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Published in: Netherlands Heart Journal 9/2018

Open Access 01-09-2018 | Original Article

Trends in patient characteristics and clinical outcome over 8 years of transcatheter aortic valve implantation

Authors: F. van Kesteren, M. S. van Mourik, E. M. A. Wiegerinck, J. Vendrik, J. J. Piek, J. G. Tijssen, K. T. Koch, J. P. S. Henriques, J. J. Wykrzykowska, R. J. de Winter, A. H. G. Driessen, A. Kaya, R. N. Planken, M. M. Vis, J. Baan

Published in: Netherlands Heart Journal | Issue 9/2018

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Abstract

Aim

In the evolving field of transcatheter aortic valve implantations (TAVI) we aimed to gain insight into trends in patient and procedural characteristics as well as clinical outcome over an 8‑year period in a real-world TAVI population.

Methods

We performed a single-centre retrospective analysis of 1,011 consecutive patients in a prospectively acquired database. We divided the cohort into tertiles of 337 patients; first interval: January 2009–March 2013, second interval: March 2013–March 2015, third interval: March 2015–October 2016.

Results

Over time, a clear shift in patient selection was noticeable towards lower surgical risks including Society of Thoracic Surgeons predicted risk of mortality score and comorbidity. The frequency of transfemoral TAVI increased (from 66.5 to 77.4%, p = 0.0015). Device success improved (from 62.0 to 91.5%, p < 0.0001) as did the frequency of symptomatic relief (≥1 New York Heart Association class difference) (from 73.8 to 87.1%, p = 0.00025). Complication rates decreased, including in-hospital stroke (from 5.0 to 2.1%, p = 0.033) and pacemaker implantations (from 10.1 to 5.9%, p = 0.033). Thirty-day mortality decreased (from 11.0 to 2.4%, p < 0.0001); after adjustment for patient characteristics, a mortality-risk reduction of 72% was observed (adjusted hazard ratio [HR]: 0.28, 95% confidence interval [CI]: 0.13–0.62). One-year mortality rates decreased (from 23.4 to 11.4%), but this was no longer significant after a landmark point was set at 30 days (mortality from 31 days until 1 year) (adjusted HR: 0.69, 95% CI: 0.41–1.16, p = 0.16).

Conclusion

A clear shift towards a lower-risk TAVI population and improved clinical outcome was observed over an 8‑year period. Survival after TAVI improved impressively, mainly as a consequence of decreased 30-day mortality.
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Literature
1.
go back to reference Nishimura RA, Otto CM, Bonow RO, et al. Cardiology. 2014;63:e57–185. Nishimura RA, Otto CM, Bonow RO, et al. Cardiology. 2014;63:e57–185.
2.
go back to reference Cribier A, Eltchaninoff H, Bash A, et al. Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis: first human case description. Circulation. 2002;106:3006–8.CrossRefPubMed Cribier A, Eltchaninoff H, Bash A, et al. Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis: first human case description. Circulation. 2002;106:3006–8.CrossRefPubMed
3.
go back to reference Leon MB, Smith CR, Mack M, et al. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010;363:1597–607.CrossRefPubMed Leon MB, Smith CR, Mack M, et al. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010;363:1597–607.CrossRefPubMed
4.
go back to reference Smith CR, Leon MB, Mack MJ, et al. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med. 2011;364:2187–98.CrossRefPubMed Smith CR, Leon MB, Mack MJ, et al. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med. 2011;364:2187–98.CrossRefPubMed
5.
go back to reference Adams DH, Popma JJ, Reardon MJ, et al. Transcatheter aortic-valve replacement with a self-expanding prosthesis. N Engl J Med. 2014;370:1790–8.CrossRefPubMed Adams DH, Popma JJ, Reardon MJ, et al. Transcatheter aortic-valve replacement with a self-expanding prosthesis. N Engl J Med. 2014;370:1790–8.CrossRefPubMed
6.
go back to reference Mylotte D, Osnabrugge RL, Windecker S, et al. Transcatheter aortic valve replacement in Europe: adoption trends and factors influencing device utilization. J Am Coll Cardiol. 2013;62:210–9.CrossRefPubMed Mylotte D, Osnabrugge RL, Windecker S, et al. Transcatheter aortic valve replacement in Europe: adoption trends and factors influencing device utilization. J Am Coll Cardiol. 2013;62:210–9.CrossRefPubMed
7.
go back to reference Leon MB, Smith CR, Mack MJ, et al. Transcatheter or surgical aortic-valve replacement in intermediate-risk patients. N Engl J Med. 2016;374:1609–20.CrossRefPubMed Leon MB, Smith CR, Mack MJ, et al. Transcatheter or surgical aortic-valve replacement in intermediate-risk patients. N Engl J Med. 2016;374:1609–20.CrossRefPubMed
8.
go back to reference Reardon MJ, Van Mieghem NM, Popma JJ, et al. Surgical or transcatheter aortic-valve replacement in intermediate-risk patients. N Engl J Med. 2017;376:1321–31.CrossRefPubMed Reardon MJ, Van Mieghem NM, Popma JJ, et al. Surgical or transcatheter aortic-valve replacement in intermediate-risk patients. N Engl J Med. 2017;376:1321–31.CrossRefPubMed
9.
go back to reference Thyregod HG, Steinbruchel DA, Ihlemann N, et al. Transcatheter versus surgical aortic valve replacement in patients with severe aortic valve stenosis: 1‑year results from the all-comers NOTION randomized clinical trial. J Am Coll Cardiol. 2015;65:2184–94.CrossRefPubMed Thyregod HG, Steinbruchel DA, Ihlemann N, et al. Transcatheter versus surgical aortic valve replacement in patients with severe aortic valve stenosis: 1‑year results from the all-comers NOTION randomized clinical trial. J Am Coll Cardiol. 2015;65:2184–94.CrossRefPubMed
10.
go back to reference Tamburino C, Barbanti M, D’Errigo P, et al. 1‑Year outcomes after transfemoral transcatheter or surgical aortic valve replacement: results from the Italian OBSERVANT study. J Am Coll Cardiol. 2015;66:804–12.CrossRefPubMed Tamburino C, Barbanti M, D’Errigo P, et al. 1‑Year outcomes after transfemoral transcatheter or surgical aortic valve replacement: results from the Italian OBSERVANT study. J Am Coll Cardiol. 2015;66:804–12.CrossRefPubMed
11.
go back to reference Thourani VH, Kodali S, Makkar RR, et al. Transcatheter aortic valve replacement versus surgical valve replacement in intermediate-risk patients: a propensity score analysis. Lancet. 2016;387:2218–25.CrossRefPubMed Thourani VH, Kodali S, Makkar RR, et al. Transcatheter aortic valve replacement versus surgical valve replacement in intermediate-risk patients: a propensity score analysis. Lancet. 2016;387:2218–25.CrossRefPubMed
12.
go back to reference 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. J Thorac Cardiovasc Surg. 2013;145:6–23.CrossRefPubMed 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. J Thorac Cardiovasc Surg. 2013;145:6–23.CrossRefPubMed
13.
go back to reference Dafni U. Landmark analysis at the 25-year landmark point. Circ Cardiovasc Qual Outcomes. 2011;4:363–71.CrossRefPubMed Dafni U. Landmark analysis at the 25-year landmark point. Circ Cardiovasc Qual Outcomes. 2011;4:363–71.CrossRefPubMed
14.
go back to reference R Development Core Team. R: a language and environment for statistical computing. Vienna: R Foundation for Statistical Computing; 2016. R Development Core Team. R: a language and environment for statistical computing. Vienna: R Foundation for Statistical Computing; 2016.
15.
go back to reference Webb JG, Doshi D, Mack MJ, et al. A randomized evaluation of the SAPIEN XT transcatheter heart valve system in patients with aortic stenosis who are not candidates for surgery. JACC Cardiovasc Interv. 2015;8:1797–806.CrossRefPubMed Webb JG, Doshi D, Mack MJ, et al. A randomized evaluation of the SAPIEN XT transcatheter heart valve system in patients with aortic stenosis who are not candidates for surgery. JACC Cardiovasc Interv. 2015;8:1797–806.CrossRefPubMed
16.
go back to reference Nijhoff F, Abawi M, Agostoni P, et al. 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:e2408.CrossRefPubMed Nijhoff F, Abawi M, Agostoni P, et al. 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:e2408.CrossRefPubMed
17.
go back to reference Binder RK, Stortecky S, Heg D, et al. Procedural results and clinical outcomes of transcatheter aortic valve implantation in Switzerland: an observational cohort study of Sapien 3 versus Sapien XT transcatheter heart valves. Circ Cardiovasc Interv. 2015;8:e2653.CrossRefPubMed Binder RK, Stortecky S, Heg D, et al. Procedural results and clinical outcomes of transcatheter aortic valve implantation in Switzerland: an observational cohort study of Sapien 3 versus Sapien XT transcatheter heart valves. Circ Cardiovasc Interv. 2015;8:e2653.CrossRefPubMed
18.
go back to reference Alli O, Rihal CS, Suri RM, et al. Learning curves for transfemoral transcatheter aortic valve replacement in the PARTNER-I trial: technical performance. Catheter Cardiovasc Interv. 2016;87:154–62.CrossRefPubMed Alli O, Rihal CS, Suri RM, et al. Learning curves for transfemoral transcatheter aortic valve replacement in the PARTNER-I trial: technical performance. Catheter Cardiovasc Interv. 2016;87:154–62.CrossRefPubMed
19.
go back to reference Minha S, Waksman R, Satler LP, et al. Learning curves for transfemoral transcatheter aortic valve replacement in the PARTNER-I trial: success and safety. Catheter Cardiovasc Interv. 2016;87:165–75.CrossRefPubMed Minha S, Waksman R, Satler LP, et al. Learning curves for transfemoral transcatheter aortic valve replacement in the PARTNER-I trial: success and safety. Catheter Cardiovasc Interv. 2016;87:165–75.CrossRefPubMed
20.
go back to reference Henn MC, Percival T, Zajarias A, et al. Learning alternative access approaches for transcatheter aortic valve replacement: implications for new transcatheter aortic valve replacement centers. Ann Thorac Surg. 2017;103:1399–405.CrossRefPubMed Henn MC, Percival T, Zajarias A, et al. Learning alternative access approaches for transcatheter aortic valve replacement: implications for new transcatheter aortic valve replacement centers. Ann Thorac Surg. 2017;103:1399–405.CrossRefPubMed
21.
go back to reference Grover FL, Vemulapalli S, Carroll JD, et al. 2016 Annual report of the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry. J Am Coll Cardiol. 2017;69:1215–30.CrossRefPubMed Grover FL, Vemulapalli S, Carroll JD, et al. 2016 Annual report of the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry. J Am Coll Cardiol. 2017;69:1215–30.CrossRefPubMed
22.
go back to reference Beohar N, Kirtane AJ, Blackstone E, et al. Trends in complications and outcomes of patients undergoing transfemoral transcatheter aortic valve replacement: experience from the PARTNER continued access registry. JACC Cardiovasc Interv. 2016;9:355–63.CrossRefPubMed Beohar N, Kirtane AJ, Blackstone E, et al. Trends in complications and outcomes of patients undergoing transfemoral transcatheter aortic valve replacement: experience from the PARTNER continued access registry. JACC Cardiovasc Interv. 2016;9:355–63.CrossRefPubMed
23.
go back to reference Rosato S, Santini F, Barbanti M, et al. Transcatheter aortic valve implantation compared with surgical aortic valve replacement in low-risk patients. Circ Cardiovasc Interv. 2016;9:e3326.CrossRefPubMed Rosato S, Santini F, Barbanti M, et al. Transcatheter aortic valve implantation compared with surgical aortic valve replacement in low-risk patients. Circ Cardiovasc Interv. 2016;9:e3326.CrossRefPubMed
25.
go back to reference Yoon SH, Ahn JM, Hayashida K, et al. Clinical outcomes following transcatheter aortic valve replacement in Asian population. JACC Cardiovasc Interv. 2016;9:926–33.CrossRefPubMed Yoon SH, Ahn JM, Hayashida K, et al. Clinical outcomes following transcatheter aortic valve replacement in Asian population. JACC Cardiovasc Interv. 2016;9:926–33.CrossRefPubMed
26.
go back to reference Arai T, Romano M, Lefevre T, et al. Direct comparison of feasibility and safety of transfemoral versus transaortic versus transapical transcatheter aortic valve replacement. JACC Cardiovasc Interv. 2016;9:2320–5.CrossRefPubMed Arai T, Romano M, Lefevre T, et al. Direct comparison of feasibility and safety of transfemoral versus transaortic versus transapical transcatheter aortic valve replacement. JACC Cardiovasc Interv. 2016;9:2320–5.CrossRefPubMed
27.
go back to reference Svensson LG, Blackstone EH, Rajeswaran J, et al. Comprehensive analysis of mortality among patients undergoing TAVR: results of the PARTNER trial. J Am Coll Cardiol. 2014;64:158–68.CrossRefPubMed Svensson LG, Blackstone EH, Rajeswaran J, et al. Comprehensive analysis of mortality among patients undergoing TAVR: results of the PARTNER trial. J Am Coll Cardiol. 2014;64:158–68.CrossRefPubMed
28.
go back to reference Dafni U. Landmark analysis at the 25-year landmark point. Circ Cardiovasc Qual Outcomes. 2011;4:363–71.CrossRefPubMed Dafni U. Landmark analysis at the 25-year landmark point. Circ Cardiovasc Qual Outcomes. 2011;4:363–71.CrossRefPubMed
Metadata
Title
Trends in patient characteristics and clinical outcome over 8 years of transcatheter aortic valve implantation
Authors
F. van Kesteren
M. S. van Mourik
E. M. A. Wiegerinck
J. Vendrik
J. J. Piek
J. G. Tijssen
K. T. Koch
J. P. S. Henriques
J. J. Wykrzykowska
R. J. de Winter
A. H. G. Driessen
A. Kaya
R. N. Planken
M. M. Vis
J. Baan
Publication date
01-09-2018
Publisher
Bohn Stafleu van Loghum
Published in
Netherlands Heart Journal / Issue 9/2018
Print ISSN: 1568-5888
Electronic ISSN: 1876-6250
DOI
https://doi.org/10.1007/s12471-018-1129-x

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