Sam Brusco, Associate Editor06.08.22
Abbott released late-breaking data for transcatheter edge-to-edge repair (TEER) device MitraClip as well as for minimally-invasive tricuspid heart valve repair device TriClip. The data was presented at this week’s TVT: The Structural Heart Summit.
Significant MR reduction to <1+ MR (81.3%-97.2%) was demonstrated. Improvements were also shown in New York Heart Association (NYHA) class (a classification of functional limitations resulting from cardiac disease) and quality of life from baseline. There were also comparable all-cause mortality and heart failure hospitalization rates.
"Doctors have been using the eligibility criteria from Abbott's COAPT trial to identify heart failure patients with secondary mitral regurgitation (MR) who would benefit from MitraClip treatment," Gilbert Tang, MD, MSc, MBA, surgical director, Structural Heart Program, Mount Sinai Health System and professor of cardiovascular surgery, Icahn School of Medicine at Mount Sinai, told the press. "The real-world findings from this study show that excellent MR reduction and one-year outcomes were achieved by MitraClip not only in COAPT-like patients but also in a wider group of patients outside the COAPT criteria, meaning physicians may be able to help even more people with secondary MR. It'll be interesting to continue following the progress of these heart failure patients after MitraClip therapy."
There was a high rate of implant (98%) and acute procedural (91%) success and at least a two-grade TR reduction in 64% of the patients. 69% of patients achieved NYHA Functional Class I/II, a 57% improvement from baseline of 12%, with a 19-point improvement in Kansas City Cardiomyopathy Questionnaire (KCCQ) score—a self-assessment of symptoms, physical and social limitations, and quality of life in heart failure patients.
"This late-breaking data debunks traditional thinking that patients with pacemakers may not be eligible for or respond to tricuspid TEER therapy," said Georg Nickenig, MD, professor and chair, Heart Center at University Hospital Bonn, Germany. "The findings continue to demonstrate TriClip's ability to reduce TR and improve quality of life in a broad range of anatomies."
Abbott will also be presenting at TVT outcomes from the global EXPAND study supporting MitraClip therapy in both women and men, and hemodynamic results from the investigational Portico NG study evaluating safety and effectiveness of the Navitor transcatheter aortic valve implantation system by valve size in patients with severe, symptomatic aortic stenosis at high or extreme surgical risk.
"These latest data presented at TVT represent compelling evidence of progress in our mission to help people live better lives through better health," said Michael Dale, senior VP of Abbott's structural heart business. "Our minimally invasive therapies for the treatment of heart valve disease are proof positive of our commitment to better serve physicians and improve the benefit of the devices we offer to the patients they treat."
One-Year MitraClip EXPAND Study Results
The real-world study used an independent echo core lab and clinical events committee. The analysis of one-year outcomes showed MitraClip’s benefit in secondary mitral regurgitation (MR) patients within eligibility for Abbott’s COAPT trial as well as outside COAPT eligibility.Significant MR reduction to <1+ MR (81.3%-97.2%) was demonstrated. Improvements were also shown in New York Heart Association (NYHA) class (a classification of functional limitations resulting from cardiac disease) and quality of life from baseline. There were also comparable all-cause mortality and heart failure hospitalization rates.
"Doctors have been using the eligibility criteria from Abbott's COAPT trial to identify heart failure patients with secondary mitral regurgitation (MR) who would benefit from MitraClip treatment," Gilbert Tang, MD, MSc, MBA, surgical director, Structural Heart Program, Mount Sinai Health System and professor of cardiovascular surgery, Icahn School of Medicine at Mount Sinai, told the press. "The real-world findings from this study show that excellent MR reduction and one-year outcomes were achieved by MitraClip not only in COAPT-like patients but also in a wider group of patients outside the COAPT criteria, meaning physicians may be able to help even more people with secondary MR. It'll be interesting to continue following the progress of these heart failure patients after MitraClip therapy."
TRILUMINATE and bRIGHT TriClip Study Insights
The single arm, multi-center trials examined if tricuspid regurgitation (TR) patients previously implanted with a pacemaker lead can benefit from TriClip. 30-day results of the TriClip and TriCip G4 TEER systems were presented.There was a high rate of implant (98%) and acute procedural (91%) success and at least a two-grade TR reduction in 64% of the patients. 69% of patients achieved NYHA Functional Class I/II, a 57% improvement from baseline of 12%, with a 19-point improvement in Kansas City Cardiomyopathy Questionnaire (KCCQ) score—a self-assessment of symptoms, physical and social limitations, and quality of life in heart failure patients.
"This late-breaking data debunks traditional thinking that patients with pacemakers may not be eligible for or respond to tricuspid TEER therapy," said Georg Nickenig, MD, professor and chair, Heart Center at University Hospital Bonn, Germany. "The findings continue to demonstrate TriClip's ability to reduce TR and improve quality of life in a broad range of anatomies."
Abbott will also be presenting at TVT outcomes from the global EXPAND study supporting MitraClip therapy in both women and men, and hemodynamic results from the investigational Portico NG study evaluating safety and effectiveness of the Navitor transcatheter aortic valve implantation system by valve size in patients with severe, symptomatic aortic stenosis at high or extreme surgical risk.
"These latest data presented at TVT represent compelling evidence of progress in our mission to help people live better lives through better health," said Michael Dale, senior VP of Abbott's structural heart business. "Our minimally invasive therapies for the treatment of heart valve disease are proof positive of our commitment to better serve physicians and improve the benefit of the devices we offer to the patients they treat."