Conclusions Systematic identification of new-onset arrhythmias following TAVI may have considerable impact on subsequent therapeutic management and long-term prognosis in this patient population
Objective To evaluate the prevalence and clinical impact of new-onset arrhythmias in patients following transcatheter aortic valve implantation ( TAVI ) .
1-Year Outcomes With the Fully Repositionable and Retrievable Lotus Transcatheter Aortic Replacement Valve in 120 High-Risk Surgical Patients With Severe Aortic Stenosis: Results of the REPRISE II Study.
OBJECTIVES This analysis presents the first report of 1-year outcomes of the 120 patients enrolled in the REPRISE II (  Repositionable Percutaneous Placement of Stenotic Aortic Valve Through Implantation of Lotus Valve System-Evaluation of Safety and Performance ) study . BACKGROUND The fully repositionable and retrievable Lotus Valve ( Boston Scientific , Marlborough , Massachusetts ) was design ed to facilitate accurate positioning , early valve function , and hemodynamic stability during deployment and to minimize paravalvular regurgitation in patients undergoing transcatheter aortic valve replacement . METHODS The study enrolled 120 symptomatic patients 70 years of age or older at 14 centers in Australia and Europe . Patients had severe calcific aortic stenosis and were deemed to be at high or extreme risk of surgery based on assessment by the heart team . RESULTS The mean age was 84.4 ± 5.3 years , 57 % ( 68 of 120 ) of patients were women , and the mean Society of Thoracic Surgeons score was 7.1 ± 4.6 . The mean baseline aortic valve area was 0.7 ± 0.2 cm(2 ) , and the mean transvalvular pressure gradient was 46.4 ± 15.0 mm Hg . All patients were successfully implanted with a Lotus Valve , and 1-year clinical follow-up was available for 99.2 % ( 119 of 120 of patients ) . The mean 1-year transvalvular aortic pressure gradient was 12.6 ± 5.7 mm Hg , and the mean valve area was 1.7 ± 0.5 cm(2 ) . A total of 88.6 % patients had no or trivial paravalvular aortic regurgitation at 1 year by independent core lab adjudication , and 97.1 % of patients were New York Heart Association functional class I or II . At 1 year , the all-cause mortality rate was 10.9 % ( 13 of 119 patients ) , disabling stroke rate was 3.4 % ( 4 of 119 patients ) , disabling bleeding rate was 5.9 % ( 7 of 119 patients ) , with no repeat procedures for valve-related dysfunction . A total of 31.9 % ( 38 of 119 patients ) underwent new permanent pacemaker implantation at 1 year . CONCLUSIONS At 1 year of follow-up , the Lotus Valve demonstrated excellent valve hemodynamics , no moderate or severe paravalvular regurgitation , and significant and sustained improvement in New York Heart Association functional class status , with good clinical outcomes . ( Repositionable Percutaneous Placement of Stenotic Aortic Valve Through Implantation of Lotus Valve System-Evaluation of Safety and Performance [ REPRISE II ] ; NCT01627691 )
Conclusions Systematic identification of new-onset arrhythmias following TAVI may have considerable impact on subsequent therapeutic management and long-term prognosis in this patient population
Objective To evaluate the prevalence and clinical impact of new-onset arrhythmias in patients following transcatheter aortic valve implantation ( TAVI ) .