Abbott’s MitraClip and TriClip Devices Evaluated in Late-Breaking Data for Mitral and Tricuspid Regurgitation

June 8, 2022—Abbott announced late-breaking data for the MitraClip transcatheter edge-to-edge repair (TEER) device and the TriClip minimally invasive tricuspid heart valve repair device. Abbott stated that the data reinforce the capabilities of the company’s structural heart solutions for both mitral and tricuspid regurgitation (MR and TR) across a broad range of patient groups experiencing leaky heart valves.

The new data were presented at TVT: The Structural Heart Summit, the annual meeting of the Cardiovascular Research Foundation, held June 8-10, 2022, in Chicago, Illinois.

According to the company, the global EXPAND study is the largest contemporary, real-world study of the MitraClip NTR/XTR that used an independent echo core lab and clinical events committee.

The analysis of 1-year clinical and functional outcomes in EXPAND demonstrated the benefit of MitraClip in secondary MR patients both within the eligibility criteria for Abbott’s COAPT trial—which studied symptomatic heart failure patients with moderate-to-severe or severe secondary MR—and outside COAPT eligibility, including patients with moderate at baseline MR and patients with advanced heart failure.

As summarized by the company, the EXPAND data across all patient groups through 1 year showed the following:

• Significant MR reduction to ≤ 1+ MR (81.3%-97.2%)
• Improvements in New York Heart Association (NYHA) class and quality of life from baseline
• 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 MR who would benefit from MitraClip treatment,” commented Gilbert Tang, MD, in Abbott’s press release.

Dr. Tang, who is Surgical Director, Structural Heart Program, Mount Sinai Health System and Professor of Cardiovascular Surgery, Icahn School of Medicine at Mount Sinai in New York, New York, continued, “The real-world findings from this study show that excellent MR reduction and 1-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.”

For the TriClip device, the company reported on combined outcomes from the TRILUMINATE and bRIGHT prospective, single-arm, multicenter trials examining whether TR patients previously implanted with a pacemaker lead can benefit from TriClip. This is the first report focusing on this group, noted Abbott.

In patients with TR and a pacemaker lead across the tricuspid valve, the following 30-day results of the TriClip and TriClip G4 TEER systems were demonstrated:

• High rates of implant (98%) and acute procedural (91%) success
• At least a two-grade TR reduction in 64% of patients
• Life-changing clinical improvements, including 69% of patients achieving NYHA functional class I/II and an improvement by 57% from baseline of 12%, with a marked 19-point improvement in Kansas City Cardiomyopathy Questionnaire (KCCQ) score

“[These] late-breaking data debunk traditional thinking that patients with pacemakers may not be eligible for or respond to tricuspid TEER therapy,” commented Georg Nickenig, MD, Professor and Chair, Heart Center at University Hospital Bonn in Bonn, Germany, in Abbott’s press release. “The findings continue to demonstrate TriClip’s ability to reduce TR and improve quality of life in a broad range of anatomies.”

Also at TVT, Abbott will be presenting outcomes from the global EXPAND study supporting the MitraClip therapy in both women and men, as well as hemodynamic results from the multicenter, international, single-arm, investigational Portico NG study evaluating the 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.

The TriClip transcatheter tricuspid valve repair system and Navitor transcatheter aortic valve are approved for investigational use only in the United States, advised the company.