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TriValve registry data reveal real-world experience with transcatheter tricuspid valve interventions
Transcatheter tricuspid valve therapy using various techniques is feasible in patients with severe symptomatic tricuspid regurgitation. More data are needed, however, on the clinical efficacy of such interventions, according to new data from the international TriValve registry.
“Different transcatheter tricuspid valve therapies have been recently emerging as therapeutic options for patients with a severe symptomatic functional tricuspid regurgitation, which conventionally represent a high-risk surgical population,” Maurizio Taramasso, MD, from the department of cardiovascular surgery at University Hospital of Zurich in Switzerland, and colleagues wrote in JACC: Cardiovascular Interventions. “Preliminary small series showed the feasibility of percutaneous tricuspid valve repair with a number of devices. However, at the initial stage of development of these therapies, several clinical, anatomic and technical issues have to be addressed and overcome before assessing their efficacy.”
The current study reports real-world data from the TriValve (Transcatheter Tricuspid Valve Therapies) registry, which was established to address these issues. Data were compiled on 106 patients with severe symptomatic tricuspid regurgitation (mean age, 76 years; 60% women; mean EuroSCORE II, 7.6%).
The most common device implanted was the MitraClip (Abbott Vascular; n = 58), followed by Trialign (Mitralign) in 17 patients, TriCinch (4Tech Cardio) in 15 patients, Forma (Edwards Lifesciences) in seven patients, Cardioband (Edwards Lifesciences) in five patients and a caval valve in three patients. Both Trialign and MitraClip were used in one patient.
In other results, 68% of cases were performed as an isolated procedure. EuroSCORE II and degree of right ventricular dysfunction were comparable among patients receiving the different devices.
At baseline, 35% of patients had a prior surgical or transcatheter left heart valve intervention. More than half (56.3%) had right ventricular dysfunction, defined as tricuspid annular plane systolic excursion less than 17 mm, and 95% had NYHA functional class III or IV HF. Tricuspid regurgitation was functional in 95.2% and the mean tricuspid annulus was 45.4 mm. The main location of the regurgitant jet was central in 76.9% of patients, preprocedural systolic pulmonary artery pressure was 37.9 mm Hg, and most patients had severely dilated vena cava.
Procedural success, defined as the patient being alive at the end of the procedure with successful device implantation and delivery system retrieval and a residual tricuspid regurgitation of 2+ or less, was 62%.
At 30 days, all-cause mortality was 3.7% and the overall incidence of MACCE was 26%. Additionally, 58% of patients had improved to NYHA functional class I or II HF.
Taramasso and colleagues concluded that the TriValve registry data demonstrate the safety and feasibility of the multiple transcatheter tricuspid valve interventions being used in high-risk patients, as well as early clinical efficacy, despite seemingly suboptimal procedural results according to the standard definition.
“Further investigations are required to better define optimal patient selection, timing of intervention, disease severity and device efficacy, creating an urgent need for standardized endpoint definition in this emerging field,” the researchers wrote.
In an accompanying editorial, Jason H. Rogers, MD, from the division of cardiovascular medicine at UC Davis Medical Center, Sacramento, California, agreed that more complete and longer follow-up, as well as randomized trials, are necessary to determine clinical benefit and formulate evidence-based clinical indications.
Interestingly, the devices studied also do not “faithfully mimic” the current surgical standards for tricuspid regurgitation, which primarily include rigid ring annuloplasty or tricuspid valve replacement, Rogers noted.
“Other technologies in development or new technologies will undoubtedly come forward in the future to address this mechanistic gap,” Rogers wrote. “Ultimately, the goal of reducing [tricuspid regurgitation] to mild or trace was not consistently achieved in this registry, and innovators should continue to strive for this goal.” – by Melissa Foster
Disclosures: Taramasso reports he has served as a consultant for 4Tech and Abbott Vascular. Please see the study for all other authors’ relevant financial disclosures. Rogers reports he has served as a consultant for Millipede and MVRx.