BACKGROUND The Direct Flow Medical transcatheter aortic valve system has a non-metallic design with a pressurized supportstructure, which allows precise positioning, retrieval and full hemodynamic assessment of valve performance prior to permanent implantation. The Direct Flow Italian registry is a nationwide registry enrolling patients treated with the Direct Flow Device in the aortic position since early 2012 to evaluate outcomes of the device in a real world setting. METHODS A group of 142 consecutive patients treated after February 2012 in 5 Italian centers has been enrolled in the registry. RESULTS Mean age was 82.86.1 years, mean EuroSCORE was 20.415.3%. Patient comorbidities were: COPD in 27.8%; moderate or severe kidney disease in 31%; peripheral vessel disease in 33.3%; previous MI in 19.1%, previous CABG in 17.0%; 67.9% of patients were in class NYHA 3 or 4. At a median follow up of 11.2 (IQR 3.0-19.0) months, 9.2% of patient died and the stroke rate was 2.1%. PM rate within 30 days of the procedure was 12.7%. Vascular complications occurred in 2.1%, conversion to cardiac surgery in 1.4% and the Direct Flow device was retrieved to switch to a different valve in 2.1% of patients. A procedural learning curve was apparent and mean fluoroscopy times significantly decreased with greater operator experience from 45.422.8 to 29.68.6 minutes when comparing the first and fourth quartiles (p¼0.02). Moderate or severe PV leak at the last available echo at a median follow up of more than 11 months was present in only 2.1% of cases. CONCLUSIONS The Direct Flow Medical transcatheter aortic valve system demonstrates excellent real-world outcomes in high-risk patients with severe aortic stenosis, with an overall low death stroke and pacemaker rate and a good valve performance.
The Italian DFM Registry: real world results of a next generation fully repositionable TAVI device
Ussia G;
2015-01-01
Abstract
BACKGROUND The Direct Flow Medical transcatheter aortic valve system has a non-metallic design with a pressurized supportstructure, which allows precise positioning, retrieval and full hemodynamic assessment of valve performance prior to permanent implantation. The Direct Flow Italian registry is a nationwide registry enrolling patients treated with the Direct Flow Device in the aortic position since early 2012 to evaluate outcomes of the device in a real world setting. METHODS A group of 142 consecutive patients treated after February 2012 in 5 Italian centers has been enrolled in the registry. RESULTS Mean age was 82.86.1 years, mean EuroSCORE was 20.415.3%. Patient comorbidities were: COPD in 27.8%; moderate or severe kidney disease in 31%; peripheral vessel disease in 33.3%; previous MI in 19.1%, previous CABG in 17.0%; 67.9% of patients were in class NYHA 3 or 4. At a median follow up of 11.2 (IQR 3.0-19.0) months, 9.2% of patient died and the stroke rate was 2.1%. PM rate within 30 days of the procedure was 12.7%. Vascular complications occurred in 2.1%, conversion to cardiac surgery in 1.4% and the Direct Flow device was retrieved to switch to a different valve in 2.1% of patients. A procedural learning curve was apparent and mean fluoroscopy times significantly decreased with greater operator experience from 45.422.8 to 29.68.6 minutes when comparing the first and fourth quartiles (p¼0.02). Moderate or severe PV leak at the last available echo at a median follow up of more than 11 months was present in only 2.1% of cases. CONCLUSIONS The Direct Flow Medical transcatheter aortic valve system demonstrates excellent real-world outcomes in high-risk patients with severe aortic stenosis, with an overall low death stroke and pacemaker rate and a good valve performance.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
