Abbott Presents Late-Breaking Data From Transcatheter Valve and Structural Heart Portfolios

May 19, 2022—Abbott announced two late-breaking data presentations evaluating the company’s TriClip minimally invasive tricuspid heart valve repair device and the Navitor, its latest-generation transcatheter aortic valve replacement/implantation (TAVR/TAVI) system. The company also highlighted new data for MitraClip and Amplatzer Amulet, from the company’s structural heart portfolio.

All data were presented at the EuroPCR 2022 conference held May 17-20 in Paris, France.

First, the 30-day results from the TriClip bRIGHT study were presented in a late-breaking data session. The real-world outcomes showed that the TriClip and TriClip G4 transcatheter edge-to-edge repair (TEER) systems significantly reduced tricuspid regurgitation (TR) and substantially improved quality of life across a wide range of anatomically diverse patients.

The data through 30 days showed the following:

• An implant success rate of 98%
• Significant TR reduction (71% moderate or less compared to 3% as baseline) with a strong safety profile (99% freedom from major adverse events)
• Life-changing clinical improvements including 78% of patients achieving New York Heart Association functional class I/II and an improvement by 57% from baseline of 21%, and an 18-point improvement in the Kansas City Cardiomyopathy Questionnaire score

Philipp Lurz, MD, Professor and Deputy Head of Cardiology, Heart Center Leipzig at the University of Leipzig in Leipzig, Germany, commented in Abbott’s press release, “Historically, people suffering from severe tricuspid regurgitation had extremely limited treatment options despite being very ill. Many were ineligible for surgery and were limited to symptom management. The late-breaking data show a high rate of implant success and significant reduction in regurgitation. TEER using TriClip has a huge potential to improve patients’ quality of life and has entered the clinical stage with widespread use in Europe.”

Next, the results from a multicenter, international, single-arm study of the Navitor TAVR/TAVI system with an active sealing cuff to minimize paravalvular leak (PVL) demonstrated improved 1-year outcomes for patients with severe, symptomatic aortic stenosis who were at high or extreme surgical risk.

Key findings include:

• Procedural success rate of 97.5%
• Rate of no/trace PVL of 70.2% and a rate of mild PVL of 28.8% through 1 year, indicating the active sealing cuff is effective in mitigating PVL
• All-cause mortality rate of 4.2% at 1 year
• Single-digit gradients (average 7.5 mm Hg) through 1 year

Dave Smith, MD, professor and consultant cardiologist at Morriston Hospital in Swansea, Wales, United Kingdom, advised in the press release, “Patients with symptomatic, severe aortic stenosis are often at high risk of complications from open-heart surgery due to their old age, frailty, or having multiple other diseases and conditions. The 1-year results from the study demonstrate that a minimally invasive TAVI procedure with a Navitor valve offers a safe and effective treatment option for these patients.”

The TriClip and Navitor devices are approved for investigational use only in the United States, stated Abbott.

Additionally, the EXPAND study showed that MitraClip therapy in heart failure patients with mitral regurgitation experiences improved symptoms and quality of life.

Finally, results from the Amulet IDE investigational device exemption trial found that women and men implanted with Abbott’s Amplatzer Amulet left atrial appendage (LAA) occluder experienced similar long-term benefits from LAA closure, which contrasts with the understanding that women have higher rates of early complications with LAA closure than men.