Late-Breaking Data Presented for Abbott’s Structural Heart Devices

September 17, 2022—Abbott announced the presentation of data from multiple investigations of the company’s devices in the minimally invasive treatment of patients with a range of structural heart diseases.

The studies evaluated the following products from Abbott: MitraClip transcatheter edge-to-edge repair (TEER) device for the treatment of patients with mitral regurgitation (MR); the TriClip transcatheter tricuspid valve repair system; the Amplatzer Amulet left atrial appendage (LAA) occluder; and the Portico self-expanding transcatheter aortic valve replacement (TAVR) system.

The data were presented at TCT 2022, the 34th annual Transcatheter Cardiovascular Therapeutics scientific symposium of the Cardiovascular Research Foundation held September 16-19 in Boston, Massachusetts.

EXPAND G4 is a prospective, multicenter, global, real-world postapproval study to support the safety and effectiveness of the MitraClip G4 system for treating MR. The MitraClip system has been commercially available in the United States since 2013 and in Europe since 2008.

The data from 30-day core lab-assessed outcomes of more than 1,000 patients were presented in a TCT late-breaking clinical science session.

According to the company, the data confirm that MitraClip provided high rates of success in MR reduction; improvements in quality of life; and low adverse-event rates.

As outlined by Abbott, key findings through 30 days include:

• Significant MR reduction to mild or less (≤ grade 1+) was achieved in 91% of patients, with a low adverse event rate with 1.3% all-cause mortality at 30 days
• 83% of patients achieved New York Heart Association functional class I/II, which is an improvement of 52% from the baseline of 31%
• An 18-point improvement in the Kansas City Cardiomyopathy Questionnaire (KCCQ) score, a 35% improvement from baseline score
• Multiple clip sizes enabled tailoring the therapy to patients’ mitral valve anatomy and expanded the spectrum of TEER-suitable patients

“MitraClip therapy has fundamentally changed the way doctors treat mitral regurgitation,” commented Jason Rogers, MD, in the company's press release. The MitraClip, he said, “provides a valuable therapy option that does not require open-heart surgery and goes beyond simply managing symptoms with medications.”

Dr. Rogers concluded, “These late-breaking data demonstrate and strengthen the evidence that Abbott's MitraClip system consistently reduces MR in a broad range of patients, while restoring proper function of the mitral valve and improving patients' quality of life.” Dr. Rogers is Professor of Cardiovascular Medicine and Director of Interventional Cardiology and Structural Heart Training Programs at the University of California, Davis Medical Center in Sacramento, California.

According to Abbott, the TRILUMINATE pivotal trial is evaluating the safety and effectiveness of TEER with the company’s TriClip system. The randomized controlled trial enrolled 700 patients with severe tricuspid regurgitation (TR) in the United States, Canada, and Europe. The TriClip is an investigational device in the United States.

The data from the roll-in cohort through 30 days showed a 99% implant success rate; 91% of patients showed at least a one-grade TR reduction with moderate or less residual TR achieved in 74% of patients. Additionally, patients achieved approximately a 17-point improvement in the KCCQ score, which was a 30% improvement from baseline score.

Three-year outcomes were presented from the Amulet IDE investigational device exemption study of the Amplatzer Amulet LAA occluder compared to the Watchman LAA closure device (Boston Scientific). The prospective, international, multicenter Amulet IDE trial is composed of more than 1,800 patients.

According to Abbott, the 3-year outcomes demonstrated the safety and effectiveness of Amulet. Device-related factors (device-related thrombosis or peridevice leak) more frequently preceded strokes in patients with Watchman than those with Amulet. Both cardiovascular and all-cause death trended higher in the Watchman device than the Amulet device.

Data were also presented from the PREDICT-LAA prospective, multicenter, randomized controlled trial that studied the use of cardiac CT-based computational models from high-resolution scans of patients’ hearts generated by the FEops HeartGuide solution in the planning of Amplatzer Amulet procedures. The 3-month data showed improved procedural efficiency and safety outcomes when procedures were planned with HeartGuide, noted the company.

Data from the CONFIDENCE registry will be presented at TCT on September 18. CONFIDENCE is an international, prospective, real-world study evaluating the safety and effectiveness of Abbott’s Portico TAVR device using the first-generation Portico delivery system in 501 patients and the second-generation FlexNav delivery system in 500 patients. The late-breaking data will assess valve hemodynamics at 30 days and 1-year survival after implantation of the Portico TAVR device, advised Abbott.