The Cardioband transcatheter tricuspid repair system showed favorable short-term outcomes in severe symptomatic functional tricuspid regurgitation (TR) patients in the TriBAND study, according to a post-market follow-up by the device’s manufacturer, Edwards Lifesciences.
The 30-day results in 61 patients were reported Tuesday in a late breaking session at EuroPCR 2021, and published simultaneously online in EuroIntervention, with authors led by Georg Nickenig of University Hospital Bonn, Germany.
Significant improvements on TR severity through annular reduction were observed, as well as early evidence of right heart re-modeling, improvements in heart failure symptoms and better quality of life.
TR is a prevalent disease – occurring in as many as 23% of heart failure patients – with limited treatment options. It is associated with high morbidity and mortality rates in general, with symptomatic severe functional TR a particularly “challenging patient population” with greater cardiovascular morbidity and mortality, the authors noted.
Treatment options remain limited “even with the availability of transcatheter TR intervention,” they said. Isolated TR surgery is rare given the condition’s often late presentation and that patients tend to suffer from multiple comorbidities, meaning it is often only surgically treated in patients already undergoing left-sided heart surgery.
Medical therapy, meanwhile, has concentrated on pre-load reduction, the authors noted.
The Cardioband device was developed in response to the issues, as a less invasive treatment option aimed at annular reduction. It is deployed via transfemoral venous access using the 26-F delivery system under transesophageal echocardiography and fluoroscopic guidance. manner. Once deployed, the implant is optimally contracted using the size adjustment tool to reduce the tricuspid annular diameter and area, thereby reducing TR.
“The predominant aetiology of TR is functional, where dilation of the tricuspid valve annulus occurs in response to either right ventricular or atrial enlargement leading to inadequate leaflet coaptation,” the researchers noted.
The current study was intended to extend experience of the Cardioband tricuspid system following the single-arm multicenter prospective TRI-REPAIR trial in patients with moderate or greater TR, which showed significantly reduced TR, lessened heart failure symptoms and low adverse event rates.
The aim of the study is to recruit up to 150 patients with moderate or worse chronic symptomatic functional TR as confirmed by echocardiographic core laboratory and heart failure symptoms with New York Heart Association (NYHA) functional class II-IV, despite diuretic therapy, who are deemed candidates for transcatheter tricuspid repair by local heart teams.
The primary endpoint is TR severity reduction between baseline and discharge, while the secondary endpoint is reducing TR severity, NYHA functional class EuroQol 5-dimensions 5-level health questionnaire (EQ-5D-5L), and overall Kansas City Cardiomyopathy Questionnaire (KCCQ) at 30 days post-implant.
Patients were excluded from the study with left ventricular ejection fraction (LVEF) less than 25%, with pulmonary arterial systolic pressure over 70 mmHg, with tricuspid proximal isovelocity surface area effective regurgitant orifice area of 2.0 cm2 or more, with severe right ventricular dysfunction, with tricuspid valve anatomy precluding proper device deployment and function, and with previous tricuspid valve repair or replacement.
Patients with a trans-tricuspid valve pacemaker or defibrillator leads impinging the tricuspid valve leaflets or with renal insufficiency requiring dialysis were also excluded.
The Tuesday report summarizes the 30-day outcomes for the first 61 patients enrolled across 13 European sites between July 2019 and December 2020, of whom 52 had 30-day follow-up.
The 61 patients were majority female (75.4%), had a mean age of 78.6 ± 5.7 years, tended to be in NYHA functional class III – IV (85.2%), often had hypertension (85%) and atrial fibrillation/ flutter (91.8%), and the majority (53%) had LVEF.
All of the patients had severe or worse functional TR based on their site-evaluated qualifying echocardiograms.
Device success was 96.7%, and at discharge, 59% (p < 0.001) achieved TR of moderate or better, while 78% had at least one grade TR reduction.
By the 30-day mark, for those who had completed follow-up, 69% of patients had achieved moderate or better TR and 85% had at least one grade TR reduction, while septolateral annular diameter was reduced by 20% (all p < 0.001). Overall KCCQ score had improved by 17 points (p < 0.001) and EQ-5D-5L health score lifted by 3 points (p = 0.313).
Within the 30 days, one patient (1.6%) had died, while composite major adverse events (MAE) happened for 19.7% (p < 0.001).
Mid-right ventricular end diastolic diameter was down 10% (p = 0.005), right atrial volume dropped by 21% (p < 0.001), and inferior vena cava diameter had decreased by 11% (p = 0.022), while 74% were in NYHA class I – II (p < 0.001).
The researchers noted potential limitations, including that the study was not randomized or blinded, meaning placebo effects of the intervention are possible. The small sample size and short-term nature of the results are also a limitation, they said.
Still, “many of these patients have no alternative therapy options,” they said. “The Cardioband tricuspid system significantly reduced tricuspid regurgitation through annular reduction and consequently reduced heart failure symptoms in a challenging patient population with severe or greater TR.”
Nickenig G, Friedrichs K, Baldus S, et al. Thirty-day outcomes of the Cardioband tricuspid system for patients with symptomatic functional tricuspid regurgitation: the TriBAND study. EuroInterv 2021 May 18 (Article in press). https://eurointervention.pcronline.com/article/thirty-day-outcomes-of-the-cardioband-tricuspid-system-for-patients-with-symptomatic-functional-tricuspid-regurgitation-the-triband-study