Data from two separate studies suggest the transfemoral EVOQUE system for transcatheter tricuspid valve replacement (TTVR) has acceptable safety and durable efficacy at both 30-day and 1-year follow-up. Both studies report early experiences from trials of Edwards Lifesciences’ transfemoral EVOQUE system and were published jointly online Monday and in the March 14 issue of JACC: Cardiovascular Interventions. The first trial, led by Susheel Kodali, MD, from Columbia University Irving Medical Center, New York, reports 30-day follow-up data from the TRISCEND study (Edwards EVOQUE Tricuspid Valve Replacement: Investigation of Safety and Clinical Efficacy after Replacement of Tricuspid Valve with Transcatheter Device) – in which the system demonstrated technical feasibility and safety, alongside reduction of tricuspid regurgitation (TR) and symptomatic improvement at 30-day follow-up. “We saw high rates of device and procedural success (98.2% and 96.4%, respectively), with low mortality and significant TR reduction,” noted Kodali and colleagues. “Importantly, these acute outcomes were associated with significant improvements in functional status and quality of life at 30 days.” The second study, led by John G. Webb, MD, from St. Paul’s Hospital, Vancouver, British Columbia, reported 1-year data from a first-in-human study – finding that the system showed efficacy and effectiveness. “In this early, compassionate use experience, the transfemoral transcatheter EVOQUE tricuspid valve replacement system demonstrated durable efficacy, persistent improvement in symptom status, and low rates of mortality and heart failure (HF) hospitalizations at a 1-year follow-up,” said Webb and colleagues. 30-day data Kodali and colleagues noted that the prospective, single-arm, multicenter TRISCEND study enrolled patients with symptomatic moderate or greater TR despite medical therapy. In the trial, 56 patients underwent TTVR with the EVOQUE system. The team reported a composite rate of major adverse events, echocardiographic parameters, and clinical, functional, and quality-of-life measures at 30 day follow-up. They reported that TR was reduced to mild or less in 98% of patients at 30 days. “The composite major adverse events rate was 26.8% at 30 days caused by 1 cardiovascular death in a patient with a failed procedure, 2 reinterventions after device embolization, 1 major access site or vascular complication, and 15 severe bleeds, of which none were life-threatening or fatal,” said the team. No myocardial infarction, stroke, renal failure, major cardiac structural complications, or device-related pulmonary embolism were observed. New York Heart Association (NYHA) scores were significantly improved to functional class I or II (78.8%; P < 0.001), while 6-minute walk distance improved 49.8 m (P < 0.001), and Kansas City Cardiomyopathy Questionnaire (KCCQ) score improved 19 points (P < 0.001). The team added that the results of the TRISCEND study compare favorably, with an in-hospital mortality of 1.8% and a 30-day major adverse events rate of 26.8% in a more complex, high-surgical-risk patient population with advanced age and significant comorbidities. “These results also compare favorably to the only other published series of TTVR, which utilized surgical cutdown and a transatrial approach in most patients and demonstrated significant TR reduction and symptomatic improvement but higher in-hospital mortality of 10%,” said Kodali and colleagues. They added that the TRISCEND study is ongoing, and a randomized pivotal trial (the TRISCEND II study) has already commenced. 1-year data Further data published by Webb and colleagues reported mid-term 1-year outcomes from the expanded first-in-human experience with the EVOQUE system, in which 27 patients with severe TR were treated in a compassionate-use experience at seven centers. The team noted that all patients had clinical right-sided HF and were deemed inoperable and unsuitable for transcatheter edge-to-edge repair by the institutional heart teams, with 89% having NYHA functional class III/IV. Clinical outcomes measured in the study included all-cause mortality, symptom status, TR severity, HF hospitalization, and major adverse cardiovascular events. Webb and colleagues revealed that 1-year mortality was 7% (2/27), while 70% of patients were NYHA functional class I/II, and 96% and 87% of patients had a TR grade ≤2+ and ≤1+, respectively, at 1 year. Between 30 days and 1 year, two patients experienced HF hospitalizations, and one patient required a new pacemaker implantation, they said. “These promising results warrant further larger-scale randomized trials with a medical control arm to validate its clinical efficacy and better define optimal patient selection,” said the team. “If these early results are confirmed, the EVOQUE system might offer a new therapeutic opportunity to this undertreated population of patients.” A new player in the field? Writing in an accompanying editorial, Azeem Latib, MD, and Andrea Scotti, MD, from Montefiore Medical Center, New York, noted that while transcatheter edge-to-edge repair techniques for TR using the TriClip (Abbott Vascular) or Pascal (Edwards Lifesciences) devices have been shown to provide a “marked and sustained clinical benefit,” the presence of frequent anatomical features such as massive or torrential TR, severe leaflet tethering, coaptation depth >10 mm or pacemaker-induced TR) can result in either the inability to treat or significant residual TR after transcatheter repair. “For this reason, transcatheter tricuspid valve replacement (TTVR) might constitute an appealing solution to address the treatment gap of patients with TR,” they noted. “TTVR with the transfemoral EVOQUE system appears as a promising technique to tackle the marked undertreatment of patients with TR,” said the editorialists. However, they noted that “as with every innovative therapy with no direct comparators, there are more questions than answers.” Indeed, the expert commentators noted that larger populations, detailed patient/procedural characteristics and standardized management strategies are now needed to promote TTVR development and identify a benchmark in the field. “These pioneering experiences tell us that the future is bright, and a new player has entered the field.” Sources: Kodali S, Hahn RT, George I, et al. Transfemoral Tricuspid Valve Replacement in Patients With Tricuspid Regurgitation: TRISCEND Study 30-Day Results. JACC Cardiovasc Interv 2022;15:471-480. Webb JG, Chuang A, Meier D, et al. Transcatheter Tricuspid Valve Replacement With the EVOQUE System: 1-Year Outcomes of a Multicenter, First-in-Human Experience. JACC Cardiovasc Interv 2022;15:481-491. Latib A, Scotti A. Transfemoral Transcatheter Tricuspid Valve Replacement: Will TV Repair Be Replaced? JACC Cardiovasc Interv 2022;15:492-495. Image Credit: nerthuz – stock.adobe.com