One Year Follow-up of the Multi-centre European PARTNER Transcatheter Heart Valve Study

Overview

Journal Eur Heart J

Publisher Oxford University Press

Specialty Cardiology & Vascular Diseases

Date 2010 Nov 16

PMID 21075775

Citations 78

Authors

Thierry Lefevre

Ari Pieter Kappetein

Ernst Wolner

Patrick Nataf

Martyn Thomas

Volker Schachinger

Bernard De Bruyne

Helene Eltchaninoff

Matthias Thielmann

Dominique Himbert

Mauro Romano

Patrick Serruys

Gerhard Wimmer-Greinecker

Affiliations

Soon will be listed here.

Abstract

Background: Transcatheter aortic valve implantation (TAVI) has emerged as a new therapeutic option in high-risk patients with severe aortic stenosis.

Aims: PARTNER EU is the first study to evaluate prospectively the procedural and mid-term outcomes of transfemoral (TF) or transapical (TA) implantation of the Edwards SAPIEN® valve involving a multi-disciplinary approach.

Methods And Results: Primary safety endpoints were 30 days and 6 months mortality. Primary efficacy endpoints were haemodynamic and functional improvement at 12 months. One hundred and thirty patients (61 TF, 69 TA), aged 82.1 ± 5.5 years were included. TA patients had higher logistic EuroSCORE (33.8 vs. 25.7%, P = 0.0005) and more peripheral disease (49.3 vs. 16.4%, P< 0.0001). Procedures were aborted in four TA (5.8%) and six TF cases (9.8%). Valve implantation was successful in the remaining patients in 95.4 and 96.4%, respectively. Thirty days and 6 months survival were 81.2 and 58.0% (TA) and 91.8 and 90.2% (TF). In both groups, mean aortic gradient decreased from 46.9 ± 18.1 to 10.9 ± 5.4 mmHg 6 months post-TAVI. In total, 78.1 and 84.8% of patients experienced significant improvement in New York Heart Association (NYHA) class, whereas 73.9 and 72.7% had improved Kansas City Cardiomyopathy Questionnaire (KCCQ) scores in TA and TF cohorts, respectively.

Conclusion: This first team-based multi-centre European TAVI registry shows promising results in high-risk patients treated by TF or TA delivery. Survival rates differ significantly between TF and TA groups and probably reflect the higher risk profile of the TA cohort. Optimal patient screening, approach selection, and device refinement may improve outcomes.

Citing Articles

Coronary Artery Disease and Revascularization in Patients Undergoing Transcatheter Aortic Valve Replacement.

Garg A, Ilyas S, Cryer M, Abbott J Rev Cardiovasc Med. 2024; 23(9):290.

PMID: 39077700 PMC: 11262379. DOI: 10.31083/j.rcm2309290.

Personalised preinterventional risk stratification of mortality, length of stay and hospitalisation costs in transcatheter aortic valve implantation using a machine learning algorithm: a pilot trial.

Zisiopoulou M, Berkowitsch A, Redlich L, Walther T, Fichtlscherer S, Leistner D Open Heart. 2024; 11(1).

PMID: 38388188 PMC: 10884198. DOI: 10.1136/openhrt-2023-002540.

Fluoroscopy Time as a New Predictor of Short-Term Outcomes after Transcatheter Aortic Valve Replacement.

Cafaro A, Spione F, Burattini O, De Feo D, Xhelo A, Palmitessa C J Cardiovasc Dev Dis. 2023; 10(11).

PMID: 37998517 PMC: 10671838. DOI: 10.3390/jcdd10110459.

Personalised Treatment in Aortic Stenosis: A Patient-Tailored Transcatheter Aortic Valve Implantation Approach.

Mitsis A, Yuan X, Eftychiou C, Avraamides P, Nienaber C J Cardiovasc Dev Dis. 2022; 9(11).

PMID: 36421942 PMC: 9694505. DOI: 10.3390/jcdd9110407.

Immediate reduction in left ventricular ejection time following TAVI is associated with improved quality of life.

Schenk J, Kho E, Rellum S, Kromhout J, Vlaar A, Baan J Front Cardiovasc Med. 2022; 9:988840.

PMID: 36187009 PMC: 9523106. DOI: 10.3389/fcvm.2022.988840.

References

Andersen H, Knudsen L, M Hasenkam J . Transluminal implantation of artificial heart valves. Description of a new expandable aortic valve and initial results with implantation by catheter technique in closed chest pigs. Eur Heart J. 1992; 13(5):704-8. DOI: 10.1093/oxfordjournals.eurheartj.a060238. View

Maillet J, Somme D, Hennel E, Lessana A, Saint-Jean O, Brodaty D . Frailty after aortic valve replacement (AVR) in octogenarians. Arch Gerontol Geriatr. 2008; 48(3):391-6. DOI: 10.1016/j.archger.2008.03.010. View

Varadarajan P, Kapoor N, Bansal R, Pai R . Clinical profile and natural history of 453 nonsurgically managed patients with severe aortic stenosis. Ann Thorac Surg. 2006; 82(6):2111-5. DOI: 10.1016/j.athoracsur.2006.07.048. View

Walther T, Falk V, Kempfert J, Borger M, Fassl J, Chu M . Transapical minimally invasive aortic valve implantation; the initial 50 patients. Eur J Cardiothorac Surg. 2008; 33(6):983-8. DOI: 10.1016/j.ejcts.2008.01.046. View

Leontyev S, Walther T, Borger M, Lehmann S, Funkat A, Rastan A . Aortic valve replacement in octogenarians: utility of risk stratification with EuroSCORE. Ann Thorac Surg. 2009; 87(5):1440-5. DOI: 10.1016/j.athoracsur.2009.01.057. View

Brown J, OBrien S, Wu C, Sikora J, Griffith B, Gammie J . Isolated aortic valve replacement in North America comprising 108,687 patients in 10 years: changes in risks, valve types, and outcomes in the Society of Thoracic Surgeons National Database. J Thorac Cardiovasc Surg. 2009; 137(1):82-90. DOI: 10.1016/j.jtcvs.2008.08.015. View

Cribier A, Eltchaninoff H, Bash A, Borenstein N, Tron C, Bauer F . Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis: first human case description. Circulation. 2002; 106(24):3006-8. DOI: 10.1161/01.cir.0000047200.36165.b8. View

Kalavrouziotis D, Li D, Buth K, Legare J . The European System for Cardiac Operative Risk Evaluation (EuroSCORE) is not appropriate for withholding surgery in high-risk patients with aortic stenosis: a retrospective cohort study. J Cardiothorac Surg. 2009; 4:32. PMC: 2717063. DOI: 10.1186/1749-8090-4-32. View

Normand S, Rector T, Neaton J, Pina I, Lazar R, Proestel S . Clinical and analytical considerations in the study of health status in device trials for heart failure. J Card Fail. 2005; 11(5):396-403. DOI: 10.1016/j.cardfail.2005.04.002. View

10.

Dolan P . Modeling valuations for EuroQol health states. Med Care. 1997; 35(11):1095-108. DOI: 10.1097/00005650-199711000-00002. View

11.

Calvi V, Puzzangara E, Pruiti G, Conti S, Di Grazia A, Ussia G . Early conduction disorders following percutaneous aortic valve replacement. Pacing Clin Electrophysiol. 2009; 32 Suppl 1:S126-30. DOI: 10.1111/j.1540-8159.2008.02298.x. View

12.

Pai R, Kapoor N, Bansal R, Varadarajan P . Malignant natural history of asymptomatic severe aortic stenosis: benefit of aortic valve replacement. Ann Thorac Surg. 2006; 82(6):2116-22. DOI: 10.1016/j.athoracsur.2006.07.043. View

13.

Walther T, Simon P, Dewey T, Wimmer-Greinecker G, Falk V, Kasimir M . Transapical minimally invasive aortic valve implantation: multicenter experience. Circulation. 2007; 116(11 Suppl):I240-5. DOI: 10.1161/CIRCULATIONAHA.106.677237. View

14.

Osswald B, Gegouskov V, Badowski-Zyla D, Tochtermann U, Thomas G, Hagl S . Overestimation of aortic valve replacement risk by EuroSCORE: implications for percutaneous valve replacement. Eur Heart J. 2008; 30(1):74-80. DOI: 10.1093/eurheartj/ehn523. View

15.

Rodes-Cabau J, Webb J, Cheung A, Ye J, Dumont E, Feindel C . Transcatheter aortic valve implantation for the treatment of severe symptomatic aortic stenosis in patients at very high or prohibitive surgical risk: acute and late outcomes of the multicenter Canadian experience. J Am Coll Cardiol. 2010; 55(11):1080-90. DOI: 10.1016/j.jacc.2009.12.014. View

16.

Green C, Porter C, Bresnahan D, Spertus J . Development and evaluation of the Kansas City Cardiomyopathy Questionnaire: a new health status measure for heart failure. J Am Coll Cardiol. 2000; 35(5):1245-55. DOI: 10.1016/s0735-1097(00)00531-3. View

17.

Bonow R, Chatterjee K, de Leon Jr A, Gaasch W, Otto C, Shanewise J . 2008 focused update incorporated into the ACC/AHA 2006 guidelines for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing.... J Am Coll Cardiol. 2008; 52(13):e1-142. DOI: 10.1016/j.jacc.2008.05.007. View

18.

Webb J, Pasupati S, Humphries K, Thompson C, Altwegg L, Moss R . Percutaneous transarterial aortic valve replacement in selected high-risk patients with aortic stenosis. Circulation. 2007; 116(7):755-63. DOI: 10.1161/CIRCULATIONAHA.107.698258. View

19.

Grube E, Buellesfeld L, Mueller R, Sauren B, Zickmann B, Nair D . Progress and current status of percutaneous aortic valve replacement: results of three device generations of the CoreValve Revalving system. Circ Cardiovasc Interv. 2009; 1(3):167-75. DOI: 10.1161/CIRCINTERVENTIONS.108.819839. View

20.

Iung B, Baron G, Butchart E, Delahaye F, Gohlke-Barwolf C, Levang O . A prospective survey of patients with valvular heart disease in Europe: The Euro Heart Survey on Valvular Heart Disease. Eur Heart J. 2003; 24(13):1231-43. DOI: 10.1016/s0195-668x(03)00201-x. View