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One year follow-up of the multi-centre European PARTNER transcatheter heart valve study.

Lefèvre T, Kappetein AP, Wolner E, Nataf P, Thomas M, Schächinger V, De Bruyne B, Eltchaninoff H, Thielmann M, Himbert D, Romano M, Serruys P, Wimmer-Greinecker G, PARTNER EU Investigator Gro - Eur. Heart J. (2010)

Bottom Line: 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.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.

View Article: PubMed Central - PubMed

Affiliation: Institut Hospitalier Jacques Cartier, 6 avenue du Noyer Lambert, Massy, France. t.lefevre@icps.com.fr

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.

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Procedural outcome.
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EHQ427F1: Procedural outcome.

Mentions: Procedural outcome and characteristics are summarized in Figure 1 and Table 3. Implantation of the Edwards SAPIEN™ THV was attempted in 61 TF and 69 TA patients. Transfemoral procedures were aborted in six patients (9.8%), due to access failure in three cases. One of these patients was treated by the TA approach 49 days later and remains alive and well. The two other patients have had no reported adverse events. A fourth procedure was aborted due to unsuccessful balloon dilatation. The patient was successfully converted to surgical AVR with no further reported adverse events. There was one case of inability to cross the valve. The procedure was stopped and the patient has had no further reported adverse events. Finally, one patient who suffered refractory arrhythmia after balloon pre-dilatation went into cardiac arrest as a result and died on the day of implant. In the remaining 55 patients, valve implantation (26, 23 mm and 29, 26 mm) was successful in 53 (96.4%). Implant failure was related to ventricular embolization in one case and aortic embolization in one. There were no cases of coronary occlusion in the TF group.Figure 1


One year follow-up of the multi-centre European PARTNER transcatheter heart valve study.

Lefèvre T, Kappetein AP, Wolner E, Nataf P, Thomas M, Schächinger V, De Bruyne B, Eltchaninoff H, Thielmann M, Himbert D, Romano M, Serruys P, Wimmer-Greinecker G, PARTNER EU Investigator Gro - Eur. Heart J. (2010)

Procedural outcome.
© Copyright Policy - creative-commons
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC3021390&req=5

EHQ427F1: Procedural outcome.
Mentions: Procedural outcome and characteristics are summarized in Figure 1 and Table 3. Implantation of the Edwards SAPIEN™ THV was attempted in 61 TF and 69 TA patients. Transfemoral procedures were aborted in six patients (9.8%), due to access failure in three cases. One of these patients was treated by the TA approach 49 days later and remains alive and well. The two other patients have had no reported adverse events. A fourth procedure was aborted due to unsuccessful balloon dilatation. The patient was successfully converted to surgical AVR with no further reported adverse events. There was one case of inability to cross the valve. The procedure was stopped and the patient has had no further reported adverse events. Finally, one patient who suffered refractory arrhythmia after balloon pre-dilatation went into cardiac arrest as a result and died on the day of implant. In the remaining 55 patients, valve implantation (26, 23 mm and 29, 26 mm) was successful in 53 (96.4%). Implant failure was related to ventricular embolization in one case and aortic embolization in one. There were no cases of coronary occlusion in the TF group.Figure 1

Bottom Line: 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.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.

View Article: PubMed Central - PubMed

Affiliation: Institut Hospitalier Jacques Cartier, 6 avenue du Noyer Lambert, Massy, France. t.lefevre@icps.com.fr

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.

Show MeSH
Related in: MedlinePlus