One Year Follow-up of PARTNER Transcatheter Heart Valve Study
One Year Follow-up of PARTNER Transcatheter Heart Valve Study
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.
Degenerative aortic stenosis is the most commonly acquired valvular heart disease in adults. Its prevalence is ~4% in patients over 80 years of age and due to population ageing, the absolute number of patients should continue to increase. In symptomatic patients, surgical aortic valve replacement (AVR) has been the treatment of choice for >40 years. However, among the elderly, up to 30–60% of cases are considered too high risk for open-heart surgery. Transcatheter aortic valve implantation (TAVI) initially described by Andersen was introduced for non-operable patients by Cribier in 2002. The transeptal approach used was technically demanding and in 2005 Webb introduced an arterial retrograde transfemoral (TF) delivery system. A transapical (TA) off-pump delivery system was also developed in 2004. The Edwards SAPIEN® transcatheter heart valve (THV) used in this study (Edwards Lifesciences Irvine, CA, USA) is a second generation bovine pericardial balloon-expandable prosthesis available in 23 and 26 mm sizes for native aortic annuli diameters between 18 and 25 mm. The TF delivery system is suitable for ileo-femoral vessels with a diameter ≥7 mm for the 22 Fr and ≥8 mm for the 24 Fr sheath. The TA approach incorporates a shorter and larger diameter (33 Fr) delivery system compatible with the 23 or 26 mm Edwards SAPIEN™ valve.
The aim of the PARTNER EU trial was to prospectively establish the role of both TF and TA in this high-risk population. This paper reports the 30 day, 6 month, and 1 year results of this study.
Abstract and Introduction
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.
Introduction
Degenerative aortic stenosis is the most commonly acquired valvular heart disease in adults. Its prevalence is ~4% in patients over 80 years of age and due to population ageing, the absolute number of patients should continue to increase. In symptomatic patients, surgical aortic valve replacement (AVR) has been the treatment of choice for >40 years. However, among the elderly, up to 30–60% of cases are considered too high risk for open-heart surgery. Transcatheter aortic valve implantation (TAVI) initially described by Andersen was introduced for non-operable patients by Cribier in 2002. The transeptal approach used was technically demanding and in 2005 Webb introduced an arterial retrograde transfemoral (TF) delivery system. A transapical (TA) off-pump delivery system was also developed in 2004. The Edwards SAPIEN® transcatheter heart valve (THV) used in this study (Edwards Lifesciences Irvine, CA, USA) is a second generation bovine pericardial balloon-expandable prosthesis available in 23 and 26 mm sizes for native aortic annuli diameters between 18 and 25 mm. The TF delivery system is suitable for ileo-femoral vessels with a diameter ≥7 mm for the 22 Fr and ≥8 mm for the 24 Fr sheath. The TA approach incorporates a shorter and larger diameter (33 Fr) delivery system compatible with the 23 or 26 mm Edwards SAPIEN™ valve.
The aim of the PARTNER EU trial was to prospectively establish the role of both TF and TA in this high-risk population. This paper reports the 30 day, 6 month, and 1 year results of this study.
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