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Why and How to Measure Aortic Valve Calcification in Patients With Aortic Stenosis Considerations for Optimal Device Selection in Transcatheter Aortic Valve Replacement: A Review Suture- or Plug-Based Large-Bore Arteriotomy Closure: A Pilot Randomized Controlled Trial 2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines Right ventricular function and outcome in patients undergoing transcatheter aortic valve replacement Anticoagulation After Surgical or Transcatheter Bioprosthetic Aortic Valve Replacement Five-Year Outcomes of Transcatheter or Surgical Aortic-Valve Replacement The Year in Cardiovascular Medicine 2020: Valvular Heart Disease: Discussing the Year in Cardiovascular Medicine for 2020 in the field of valvular heart disease is Professor Helmut Baumgartner and Dr Javier Bermejo. Mark Nicholls reports Incidence, predictors, and outcomes associated with acute kidney injury in patients undergoing transcatheter aortic valve replacement: from the BRAVO-3 randomized trial Transcatheter versus Surgical Aortic Valve Replacement in Patients with Prior Cardiac Surgery in the Randomized PARTNER 2A Trial

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.