Specific recommendations for implantation of each prosthesis , taking into consideration the presence of pre-existent conduction abnormalities and anatomical factors , may be needed to reduce the risk of PPI
Aims The incidence of new-onset conduction abnormalities requiring permanent pacemaker implantation ( PPI ) after transcatheter aortic valve implantation ( TAVI ) with new-generation prostheses remains debated .
This systematic review analyses the incidence of PPI after TAVI  with new-generation devices and evaluates the electrical , anatomical , and procedural factors associated with PPI .
In addition , the incidence of PPI after  TAVI with early generation prostheses was review ed for comparison .
Prospective multicenter evaluation of the direct flow medical transcatheter aortic valve.
OBJECTIVES The study sought a prospect i ve multicenter nonr and omized evaluation of the Direct Flow Medical ( DFM ) system for the treatment of severe aortic stenosis . BACKGROUND The DFM transcatheter aortic valve system is a nonmetallic design with a pressurized support structure that allows precise positioning , retrieval , and assessment of valve performance prior to permanent implantation . METHODS One hundred high surgical risk patients with severe aortic stenosis were evaluated for the primary endpoint . There were 75 patients in the group evaluable for the secondary endpoints and 25 in the pre-specified roll-in training phase .  Echocardiographic and angiographic data were evaluated by an independent core laboratory and adverse events adjudicated by clinical event committee and classified according to Valve Academic Research Consortium ( VARC ) criteria . RESULTS There was 99 % freedom from all cause mortality at 30 days ( primary endpoint ) . VARC criteria defined 30 day combined freedom from patient safety event rate was 91 % and overall device success was 93 % . The post-implantation echocardiography results demonstrated mild or no aortic regurgitation in 99 % ( 73 of 74 ) with a mean gradient of 12.6 ± 7.1 mm Hg ( n = 72 ) and effective orifice area of 1.50 ± 0.56 cm(2 ) and New York Heart Association functional class was I or II in 92 % of cases . CONCLUSIONS The present study demonstrates the safety and efficacy of the DFM system in surgical high risk patients with severe aortic stenosis and complex anatomy aortic regurgitation was less than moderate in 99 % of patients
Specific recommendations for implantation of each prosthesis , taking into consideration the presence of pre-existent conduction abnormalities and anatomical factors , may be needed to reduce the risk of PPI
Aims The incidence of new-onset conduction abnormalities requiring permanent pacemaker implantation ( PPI ) after transcatheter aortic valve implantation ( TAVI ) with new-generation prostheses remains debated .
This systematic review analyses the incidence of PPI after TAVI  with new-generation devices and evaluates the electrical , anatomical , and procedural factors associated with PPI .
In addition , the incidence of PPI after  TAVI with early generation prostheses was review ed for comparison .