Objectives:This study describes a real-world experience of implanting a novel balloon expandable transcatheter aortic valve replacement(TAVR)compared to devices commonly used in clinical practice.As a secondary object...Objectives:This study describes a real-world experience of implanting a novel balloon expandable transcatheter aortic valve replacement(TAVR)compared to devices commonly used in clinical practice.As a secondary objective,the effect of balloon angioplasty(BAV)before TAVR on the transvalvular gradient 1 and 30 days after implantation was evaluated.Background:For most commercial TAVR valves,the 30-day average mean aortic valve gradients have been re-ported.Our experience with the Lotus Valve System had indicated higher immediate post-implant gradients than those in the literature.We sought to evaluate both these valves,comparing them to other valves.Methods:We analyzed discharge and 30-day echocardiograms of Lotus valves from 7/5/2019 to 8/27/2020.In re-sponse to higher-than-expected post-implant gradients,patients from 11/4/19 to 8/27/20 underwent BAV before the valve implantation,whereas patients from 7/5/19 to 10/18/19 did not(no-BAV).We compared these samples to each other and to a random sampling of TAVR valves implanted by the same interventionalist.Results:At discharge,27 patients received Lotus valves.The average mean aortic valve gradient was 16.7 mmHg(SD=5.5 mmHg)for the no-BAV and 14.7 mmHg(SD=3.7 mmHg)for the BAV(P=0.177)cohorts.No-BAV Lotus valve mean gradients were significantly higher(P<0.001)than those of the Sapien valve(M=12 mmHg,SD=4.3)and CoreValve(M=9.18 mmHg,SD=3.96).At the 30-day assessment,the mean gradients in the no-BAV and BAV groups were similar to those in the literature(M=11 mmHg SD 3.5;M=12 mmHg,SD 4.1(P=0.287))and those of other valves.Conclusions:The Lotus valve demonstrated higher post-implantation gradients than other valves.This effect was not attenuated by BAV.These elevated gradients were not significant at the 30-day follow-up.展开更多
文摘Objectives:This study describes a real-world experience of implanting a novel balloon expandable transcatheter aortic valve replacement(TAVR)compared to devices commonly used in clinical practice.As a secondary objective,the effect of balloon angioplasty(BAV)before TAVR on the transvalvular gradient 1 and 30 days after implantation was evaluated.Background:For most commercial TAVR valves,the 30-day average mean aortic valve gradients have been re-ported.Our experience with the Lotus Valve System had indicated higher immediate post-implant gradients than those in the literature.We sought to evaluate both these valves,comparing them to other valves.Methods:We analyzed discharge and 30-day echocardiograms of Lotus valves from 7/5/2019 to 8/27/2020.In re-sponse to higher-than-expected post-implant gradients,patients from 11/4/19 to 8/27/20 underwent BAV before the valve implantation,whereas patients from 7/5/19 to 10/18/19 did not(no-BAV).We compared these samples to each other and to a random sampling of TAVR valves implanted by the same interventionalist.Results:At discharge,27 patients received Lotus valves.The average mean aortic valve gradient was 16.7 mmHg(SD=5.5 mmHg)for the no-BAV and 14.7 mmHg(SD=3.7 mmHg)for the BAV(P=0.177)cohorts.No-BAV Lotus valve mean gradients were significantly higher(P<0.001)than those of the Sapien valve(M=12 mmHg,SD=4.3)and CoreValve(M=9.18 mmHg,SD=3.96).At the 30-day assessment,the mean gradients in the no-BAV and BAV groups were similar to those in the literature(M=11 mmHg SD 3.5;M=12 mmHg,SD 4.1(P=0.287))and those of other valves.Conclusions:The Lotus valve demonstrated higher post-implantation gradients than other valves.This effect was not attenuated by BAV.These elevated gradients were not significant at the 30-day follow-up.