Weighing a TAVR outcome

Is mild aortic regurgitation following transcatheter aortic valve replacement okay, or do patients face an unacceptably high risk for death when their procedure has that outcome?

That’s a question dogging transcatheter aortic valve replacement (TAVR) right now that will only get answered as more patients undergo TAVR and follow-up times increase. But it is also a question that probably comes up almost every day in cath labs performing TAVR.

Last month during EuroPCR, I heard the wrap-up for a just-completed TAVR case. After the replacement valve was placed, the patient had mild aortic regurgitation, and a key decision of the case was whether or not to try to fiddle with the valve to improve on that. Given the valvular calcification and the frailty of the patient, the physicians in the lab as well as those on the panel in the hall uniformly agreed that stopping at mild regurgitation was the best option for this case.

But hearing that, I also recalled the comment in March from Dr. Friederich-Wilhelm Mohr when he was reporting the most recent results from the German national TAVR registry. Dr. Mohr looked at the outcomes of patients with mild regurgitation and concluded that "regurgitation matters, whether is it mild or severe." In the German 1-year outcome results from nearly 2,700 patients who underwent transvascular TAVR, those who emerged with mild aortic regurgitation had a 25% 1-year mortality rate, compared with a 21% rate among patients who had no regurgitation flowing TAVR, and compared with a 50% rate in the small number of patients who emerged from TAVR with severe regurgitation. Dr. Mohr did not say whether he applied statistical analysis to those 21% and 25% results to determine if it was a significant difference.

Back to the case, is that possible 4% absolute difference in 1-year mortality worth the risk of possible clinical complications that fiddling with the valve might cause and with no guarantee of getting an improved result? The interventionalists thought that in this patient, the answer was to leave well enough alone.

But in the bigger picture, the answer lies in better TAVR devices that produce higher rates of patients with no regurgitation. In the German registry using 2011 TAVR technology, 56% of the transvascular TAVR patients had mild aortic regurgitation after their procedure finished. Dr. Mohr said that rate was too high.

Also at EuroPCR was a report from Dr. Ian Meredith from Melbourne on 60 patients treated with a new TAVR system designed to allow easy repositioning of the valve. Also, surrounding the valve as it gets placed in the patient’s heart is a layer of something Dr. Meredith likened to cling wrap, to fill and seal the small crevices around the new valve. In 53 patients with 30-day follow-up, one patient (2%) had moderate regurgitation, 10 patients (19%) had mild regurgitation, 13 (25%) had trace regurgitation, and 29 (55%) had no regurgitation. If those rates hold up with wider and longer use, it would be an advance, though still room for further improvement. By comparison, typical reported rates using the approved Sapien TAVR device show 15% moderate or severe regurgitation at 30 days following TAVR, 45% mild, and less than 20% with none.

Is mild aortic regurgitation following transcatheter aortic valve replacement okay, or do patients face an unacceptably high risk for death when their procedure has that outcome?

That’s a question dogging transcatheter aortic valve replacement (TAVR) right now that will only get answered as more patients undergo TAVR and follow-up times increase. But it is also a question that probably comes up almost every day in cath labs performing TAVR.

Last month during EuroPCR, I heard the wrap-up for a just-completed TAVR case. After the replacement valve was placed, the patient had mild aortic regurgitation, and a key decision of the case was whether or not to try to fiddle with the valve to improve on that. Given the valvular calcification and the frailty of the patient, the physicians in the lab as well as those on the panel in the hall uniformly agreed that stopping at mild regurgitation was the best option for this case.

But hearing that, I also recalled the comment in March from Dr. Friederich-Wilhelm Mohr when he was reporting the most recent results from the German national TAVR registry. Dr. Mohr looked at the outcomes of patients with mild regurgitation and concluded that "regurgitation matters, whether is it mild or severe." In the German 1-year outcome results from nearly 2,700 patients who underwent transvascular TAVR, those who emerged with mild aortic regurgitation had a 25% 1-year mortality rate, compared with a 21% rate among patients who had no regurgitation flowing TAVR, and compared with a 50% rate in the small number of patients who emerged from TAVR with severe regurgitation. Dr. Mohr did not say whether he applied statistical analysis to those 21% and 25% results to determine if it was a significant difference.

Back to the case, is that possible 4% absolute difference in 1-year mortality worth the risk of possible clinical complications that fiddling with the valve might cause and with no guarantee of getting an improved result? The interventionalists thought that in this patient, the answer was to leave well enough alone.

But in the bigger picture, the answer lies in better TAVR devices that produce higher rates of patients with no regurgitation. In the German registry using 2011 TAVR technology, 56% of the transvascular TAVR patients had mild aortic regurgitation after their procedure finished. Dr. Mohr said that rate was too high.

Also at EuroPCR was a report from Dr. Ian Meredith from Melbourne on 60 patients treated with a new TAVR system designed to allow easy repositioning of the valve. Also, surrounding the valve as it gets placed in the patient’s heart is a layer of something Dr. Meredith likened to cling wrap, to fill and seal the small crevices around the new valve. In 53 patients with 30-day follow-up, one patient (2%) had moderate regurgitation, 10 patients (19%) had mild regurgitation, 13 (25%) had trace regurgitation, and 29 (55%) had no regurgitation. If those rates hold up with wider and longer use, it would be an advance, though still room for further improvement. By comparison, typical reported rates using the approved Sapien TAVR device show 15% moderate or severe regurgitation at 30 days following TAVR, 45% mild, and less than 20% with none.

Is mild aortic regurgitation following transcatheter aortic valve replacement okay, or do patients face an unacceptably high risk for death when their procedure has that outcome?

That’s a question dogging transcatheter aortic valve replacement (TAVR) right now that will only get answered as more patients undergo TAVR and follow-up times increase. But it is also a question that probably comes up almost every day in cath labs performing TAVR.

Last month during EuroPCR, I heard the wrap-up for a just-completed TAVR case. After the replacement valve was placed, the patient had mild aortic regurgitation, and a key decision of the case was whether or not to try to fiddle with the valve to improve on that. Given the valvular calcification and the frailty of the patient, the physicians in the lab as well as those on the panel in the hall uniformly agreed that stopping at mild regurgitation was the best option for this case.

But hearing that, I also recalled the comment in March from Dr. Friederich-Wilhelm Mohr when he was reporting the most recent results from the German national TAVR registry. Dr. Mohr looked at the outcomes of patients with mild regurgitation and concluded that "regurgitation matters, whether is it mild or severe." In the German 1-year outcome results from nearly 2,700 patients who underwent transvascular TAVR, those who emerged with mild aortic regurgitation had a 25% 1-year mortality rate, compared with a 21% rate among patients who had no regurgitation flowing TAVR, and compared with a 50% rate in the small number of patients who emerged from TAVR with severe regurgitation. Dr. Mohr did not say whether he applied statistical analysis to those 21% and 25% results to determine if it was a significant difference.

Back to the case, is that possible 4% absolute difference in 1-year mortality worth the risk of possible clinical complications that fiddling with the valve might cause and with no guarantee of getting an improved result? The interventionalists thought that in this patient, the answer was to leave well enough alone.

But in the bigger picture, the answer lies in better TAVR devices that produce higher rates of patients with no regurgitation. In the German registry using 2011 TAVR technology, 56% of the transvascular TAVR patients had mild aortic regurgitation after their procedure finished. Dr. Mohr said that rate was too high.

Also at EuroPCR was a report from Dr. Ian Meredith from Melbourne on 60 patients treated with a new TAVR system designed to allow easy repositioning of the valve. Also, surrounding the valve as it gets placed in the patient’s heart is a layer of something Dr. Meredith likened to cling wrap, to fill and seal the small crevices around the new valve. In 53 patients with 30-day follow-up, one patient (2%) had moderate regurgitation, 10 patients (19%) had mild regurgitation, 13 (25%) had trace regurgitation, and 29 (55%) had no regurgitation. If those rates hold up with wider and longer use, it would be an advance, though still room for further improvement. By comparison, typical reported rates using the approved Sapien TAVR device show 15% moderate or severe regurgitation at 30 days following TAVR, 45% mild, and less than 20% with none.