PMID- 21075775 OWN - NLM STAT- MEDLINE DCOM- 20111209 LR - 20220409 IS - 1522-9645 (Electronic) IS - 0195-668X (Print) IS - 0195-668X (Linking) VI - 32 IP - 2 DP - 2011 Jan TI - One year follow-up of the multi-centre European PARTNER transcatheter heart valve study. PG - 148-57 LID - 10.1093/eurheartj/ehq427 [doi] AB - 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(R) 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. FAU - Lefevre, Thierry AU - Lefevre T AD - Institut Hospitalier Jacques Cartier, 6 avenue du Noyer Lambert, Massy, France. t.lefevre@icps.com.fr FAU - Kappetein, Ari Pieter AU - Kappetein AP FAU - Wolner, Ernst AU - Wolner E FAU - Nataf, Patrick AU - Nataf P FAU - Thomas, Martyn AU - Thomas M FAU - Schachinger, Volker AU - Schachinger V FAU - De Bruyne, Bernard AU - De Bruyne B FAU - Eltchaninoff, Helene AU - Eltchaninoff H FAU - Thielmann, Matthias AU - Thielmann M FAU - Himbert, Dominique AU - Himbert D FAU - Romano, Mauro AU - Romano M FAU - Serruys, Patrick AU - Serruys P FAU - Wimmer-Greinecker, Gerhard AU - Wimmer-Greinecker G CN - PARTNER EU Investigator Group LA - eng PT - Evaluation Study PT - Journal Article PT - Multicenter Study PT - Research Support, Non-U.S. Gov't DEP - 20101112 PL - England TA - Eur Heart J JT - European heart journal JID - 8006263 SB - IM MH - Aged MH - Aged, 80 and over MH - Aortic Valve/*surgery MH - Aortic Valve Stenosis/mortality/*surgery MH - Cardiac Catheterization/*methods/mortality MH - Cause of Death MH - Echocardiography MH - Female MH - Follow-Up Studies MH - *Heart Valve Prosthesis MH - Heart Valve Prosthesis Implantation/*methods/mortality MH - Humans MH - Kaplan-Meier Estimate MH - Male MH - Prospective Studies MH - Treatment Outcome PMC - PMC3021390 FIR - Baumgartner, H IR - Baumgartner H FIR - Glogar, D IR - Glogar D FIR - Kasimir, M T IR - Kasimir MT FIR - Simon, P IR - Simon P FIR - Wisser, W IR - Wisser W FIR - Wolner, E IR - Wolner E FIR - Al-Attar, N IR - Al-Attar N FIR - Himbert, D IR - Himbert D FIR - Nataf, P IR - Nataf P FIR - Vahanian, A IR - Vahanian A FIR - El-Gamel, A IR - El-Gamel A FIR - MacCarthy, P IR - MacCarthy P FIR - Thomas, M IR - Thomas M FIR - Wendler, O IR - Wendler O FIR - Eggebrecht, H IR - Eggebrecht H FIR - Erbel, R IR - Erbel R FIR - Jakob, H IR - Jakob H FIR - Kahlert, P IR - Kahlert P FIR - Sack, S IR - Sack S FIR - Thielmann, M IR - Thielmann M FIR - Wendt, D IR - Wendt D FIR - Donzeau-Gouge, P IR - Donzeau-Gouge P FIR - Farge, A IR - Farge A FIR - Lefevre, T IR - Lefevre T FIR - Morice, M-C IR - Morice MC FIR - Romano, M IR - Romano M FIR - Casselman, F IR - Casselman F FIR - De Bruyne, B IR - De Bruyne B FIR - Degrieck, I IR - Degrieck I FIR - Vanderheyden, Marc IR - Vanderheyden M FIR - Vanermen, H IR - Vanermen H FIR - Bessou, J-P IR - Bessou JP FIR - Cribier, A IR - Cribier A FIR - Eltchaninoff, H IR - Eltchaninoff H FIR - Litzler, Y-P IR - Litzler YP FIR - Doss, M IR - Doss M FIR - Fichtlscherer, S IR - Fichtlscherer S FIR - Schachinger, V IR - Schachinger V FIR - Wimmer-Greinecker, G IR - Wimmer-Greinecker G FIR - DeJaegere, P IR - DeJaegere P FIR - Kappetein, A P IR - Kappetein AP FIR - Serruys, P IR - Serruys P EDAT- 2010/11/16 06:00 MHDA- 2011/12/14 06:00 PMCR- 2010/11/12 CRDT- 2010/11/16 06:00 PHST- 2010/11/16 06:00 [entrez] PHST- 2010/11/16 06:00 [pubmed] PHST- 2011/12/14 06:00 [medline] PHST- 2010/11/12 00:00 [pmc-release] AID - ehq427 [pii] AID - 10.1093/eurheartj/ehq427 [doi] PST - ppublish SO - Eur Heart J. 2011 Jan;32(2):148-57. doi: 10.1093/eurheartj/ehq427. Epub 2010 Nov 12.