New research and analyses from the SWISS-APERO, Tendyne SUMMIT Pivotal, TRILUMINATE Pivotal and EXPAND G4 trials were part of a Late-Breaking Clinical Science session at TCT 2023 in collaboration with JACC. Key highlights from each trial are below.

In EXPAND G4, Ralph Stephan von Bardeleben, MD, et al., found mitral transcatheter edge-to-edge repair (M-TEER) with the fourth generation MitraClip G4 device was safe and effective at one year in a contemporary, real-world cohort of 1,164 patients with primary and secondary mitral regurgitation (MR). The findings, which were simultaneously published in JACC, highlighted a durable reduction in MR to mild or less in 92.6% of patients and to none or trace in 44.2% (p<0.0001 vs. baseline). Few major adverse events through one year were observed (<0.0001 vs. baseline). In a related JACC editorial, Fabien Praz, MD, and Daryoush Samim, MD, called the study a “valuable addition to the knowledge concerning the contemporary real-world use of latest-generation devices.” They added: “Prompted by technical innovation and, even more importantly, growing team experience, M-TEER has matured as the treatment of choice of symptomatic patients with severe [secondary MR] and now emerges as a competitive alternative to surgery in [primary MR]patients at increased operative risk. …Maturity is not measured by age but built by experience.”

In pre-specified analyses of the SWISS-APERO trial, researchers assessed one-year outcomes in 221 patients undergoing clinically indicated left atrial appendage closure with either the Amulet (n=111) or Watchman FLX device (n=110). Specifically, rates of left atrial appendage patency (PA) and device-related thrombus (DRT) were assessed at 13 months using cardiac computed tomography angiography. Overall findings showed rates of PA, its subtypes and DRT were similar between the randomised device groups. In addition, rates of clinical outcomes at 13 months also did not vary between the study groups. Researchers did note that two-thirds of 45-day PAs – especially those related to side-gap leaks – persisted at 13 months. The results were simultaneously published in Circulation.

Jason H. Rogers, MD, FACC, and Vinod H. Thourani, MD, FACC, presented the results from Tendyne SUMMIT Pivotal Roll-In and SUMMIT MAC Arm Outcomes trials. Key takeaways from SUMMIT Pivotal Roll-In, showed 100% procedural survival and few procedural complications among the 100 patients who were treated at sites without prior Tendyne TMVR experience and the majority of whom were deemed not suitable for TEER. According to Rogers, Thourani and colleagues, most adverse events occurred within the first month post-procedure and elimination of MR was sustained through one year. Additionally, improvements in heart failure symptoms and quality of live were observed at one year. In SUMMIT MAC ARM, the researchers noted high procedural success with a 30-day mortality of 6.8% among the 103 patients who underwent transapical TMVR for severe mitral annular calcification (MAC) and MR/MS. The most frequent procedural adverse event was major bleeding and MR elimination was associated with 30-day hemodynamic improvements, as well as improved functional status and quality of life.

TRILUMINATE Pivotal was the first randomized, controlled trial to evaluate TEER in subjects with severe tricuspid regurgitation (TR). It included two arms, the first of which randomized patients expected to achieve TR of moderate or less to either the TriClip device or medical therapy along. A separate single arm included patients who were treated with the TriClip device only and were expected to achieve TR reduction by at least one grade (but not to moderate or less). “Despite the complex anatomies present in the single-arm cohort, outcomes between single-arm and randomized cohorts were comparable, including 30-day safety, sustained TR reduction, and 12-month change in KCCQ-OS,” researchers said. “Data from all randomized subjects in the TRILUMINATE Pivotal trial strengthen the conclusions of the previously reported primary cohort analysis.”