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 .
Comparison of balloon-expandable vs self-expandable valves in patients undergoing transcatheter aortic valve replacement: the CHOICE randomized clinical trial.
IMPORTANCE Transcatheter aortic valve replacement ( TAVR ) is an effective treatment option for high-risk patients with severe aortic stenosis . Different from surgery , transcatheter deployment of valves requires either a balloon-exp and able or self-exp and able system . A r and omized comparison of these 2 systems has not been performed . OBJECTIVE To determine whether the balloon-exp and able device is associated with a better success rate than the self-exp and able device . DESIGN , SETTING , AND PATIENTS The CHOICE study was an investigator-initiated trial in high-risk patients with severe aortic stenosis and an anatomy suitable for the transfemoral TAVR procedure . One hundred twenty-one patients were r and omly assigned to receive a balloon-exp and able valve ( Edwards Sapien XT ) and 120 were assigned to receive a self-exp and able valve ( Medtronic CoreValve ) . Patients were enrolled between March 2012 and December 2013 at 5 centers in Germany . INTERVENTIONS Transfemoral TAVR with a balloon-exp and able or self-exp and able device . MAIN OUTCOMES AND MEASURES The primary end point was device success , which is a composite end point including successful vascular access and deployment of the device and retrieval of the delivery system , correct position of the device , intended performance of the heart valve without moderate or severe regurgitation , and only 1 valve implanted in the proper anatomical location . Secondary end points included cardiovascular mortality , bleeding and vascular complications , postprocedural pacemaker placement , and a combined safety end point at 30 days , including all-cause mortality , major stroke , and other serious complications . RESULTS Device success occurred in 116 of 121 patients ( 95.9 % ) in the balloon-exp and able valve group and 93 of 120 patients ( 77.5 % ) in the self-exp and able valve group ( relative risk [ RR ] , 1.24 , 95 % CI , 1.12 - 1.37 , P < .001 ) . This was attributed to a significantly lower frequency of residual more-than-mild aortic regurgitation ( 4.1 % vs 18.3 % ; RR , 0.23 ; 95 % CI , 0.09 - 0.58 ; P < .001 ) and the less frequent need for implanting more than 1 valve ( 0.8 % vs 5.8 % , P = .03 ) in the balloon-exp and able valve group . Cardiovascular mortality at 30 days was 4.1 % in the balloon-exp and able valve group and 4.3 % in the self-exp and able valve group ( RR , 0.97 ; 95 % CI , 0.29 - 3.25 ; P = .99 ) . Bleeding and vascular complications were not significantly different , and the combined safety end point occurred in 18.2 % of those in the balloon-exp and able valve group and 23.1 % of the self-exp and able valve group ( RR , 0.79 ; 95 % CI , 0.48 - 1.30 ; P = .42 ) . Placement of a new permanent pacemaker was less frequent in the balloon-exp and able valve group ( 17.3 % vs 37.6 % , P = .001 ) . CONCLUSIONS AND RELEVANCE Among patients with high-risk aortic stenosis undergoing TAVR , the use of a balloon-exp and able valve result ed in a greater rate of device success than use of a self-exp and able valve . TRIAL REGISTRATION clinical trials.gov Identifier : NCT01645202
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 .