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Transcatheter Aortic Valve Replacement

科研文章

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Transcatheter Aortic-Valve Replacement with a Self-Expanding Valve in Low-Risk Patients Comparative Accuracy of Focused Cardiac Ultrasonography and Clinical Examination for Left Ventricular Dysfunction and Valvular Heart Disease: A Systematic Review and Meta-analysis Surgical or Transcatheter Aortic-Valve Replacement in Intermediate-Risk Patients Transcatheter Versus Surgical Aortic Valve Replacement in Patients With Severe Aortic Valve Stenosis: 1-Year Results From the All-Comers NOTION Randomized Clinical Trial Transcatheter Laceration of Aortic Leaflets to Prevent Coronary Obstruction During Transcatheter Aortic Valve Replacement: Concept to First-in-Human Preventing Coronary Obstruction During Transcatheter Aortic Valve Replacement From Computed Tomography to BASILICA A prospective, randomised trial of transapical transcatheter aortic valve implantation vs. surgical aortic valve replacement in operable elderly patients with aortic stenosis: the STACCATO trial Transcatheter or Surgical Aortic-Valve Replacement in Intermediate-Risk Patients 2017 AHA/ACC Focused Update of the 2014 AHA/ACC Guideline for the Management of Patients With Valvular Heart Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines Transcatheter aortic-valve replacement with a self-expanding prosthesis

Clinical Trial2012 Jul 20;8(3):383-9.

JOURNAL:EuroIntervention. Article Link

A prospective, randomised trial of transapical transcatheter aortic valve implantation vs. surgical aortic valve replacement in operable elderly patients with aortic stenosis: the STACCATO trial

Nielsen HH1, Klaaborg KE, Nissen H et al. Keywords: a-TAVI; SAVR; isolated aortic valve stenosis; elderly; low-risk patients; 30-day outcome

ABSTRACT


AIMS - In a prospective randomised trial we aimed to compare transapical transcatheter aortic valve implantation (a-TAVI) with surgical aortic valve replacement (SAVR) in operable elderly patients.

 

METHODS AND RESULTS - The study was designed as a randomised controlled trial of a-TAVI (Edwards SAPIEN heart valve system; Edwards Lifesciences, Irvine, CA, USA) vs. SAVR. Operable patients with isolated aortic valve stenosis and an age 75 years were included. The primary endpoint was the composite of all-cause mortality, cerebral stroke and/or renal failure requiring haemodialysis at 30 days. After advice from the Data Safety Monitoring Board, the study was prematurely terminated after the inclusion of 70 patients because of an excess of events in the a-TAVI group. The primary endpoint was met in five a-TAVI patients (two deaths, two strokes, and one case of renal failure requiring dialysis) vs. one stroke in the SAVR group (p=0.07). In the a-TAVI group, one patient was converted to SAVR because of an abnormally positioned heart, and four patients were re-operated with open heart surgery because of annulus rupture (n=1), severe paravalvular leakage (n=2), and blockage of the left coronary artery (n=1). In the SAVR group, one patient was converted to TAVI because of a large intra-thoracic goitre.

 

CONCLUSIONS - Given the limitations of a small prematurely terminated study, our results suggest that a-TAVI in its present form may be associated with complications and device success rates in low-risk patients similar or even inferior to those found in high-risk patients with aortic valve stenosis. This will probably change in the near future with improved catheter based devices and better pre-procedural assessment.