US Societies Lay Out Requirements for Transcatheter Tricuspid Valve Procedures

New guidance from several major societies, including the American College of Cardiology (ACC) and American Heart Association (AHA), is now available for operators and institutions looking to start and maintain a program dedicated to transcatheter tricuspid valve interventions (TTVIs).

The consensus document, which was chaired by Patrick O’Gara, MD (Brigham and Women’s Hospital, Boston, MA), and published in JACC, emphasizes the necessary aspects of a program aimed at treating patients with native valve severe tricuspid regurgitation (TR) using any of the devices currently approved by the US Food and Drug Administration, such as Evoque (Edwards Lifesciences) for transcatheter tricuspid valve replacement (TTVR) and TriClip (Abbott) for transcatheter edge-to-edge repair (TEER).

Both TTVR and TEER are reserved for patients with severe TR who remain symptomatic despite guideline-directed medical therapy. The two available devices were approved based on improvements in quality-of-life metrics, with neither option shown to reduce the risk of mortality. 

“Following FDA approval, there has been growing interest in offering percutaneous tricuspid interventions to patients with tricuspid regurgitation,” Dharam Kumbhani, MD (UT Southwestern Medical Center, Dallas, TX), an author of the consensus document, told TCTMD. “This is a challenging patient population, with uncertainties around optimal patient selection, timing of intervention, and long-term outcomes, as well as unique considerations such as lead management postintervention.”

Given the challenges, successful treatment requires a “structured, programmatic approach” that’s backed by “a cohesive, high-functioning, multidisciplinary team,” he said.

The multidisciplinary heart team, which is a “foundational element of the institutional requirements” of a TTVI program, should include a general/valve cardiologist, heart failure (HF) physician, interventional cardiologist, cardiac valve surgeon, interventional echocardiographer, and other physicians with expertise in multimodality imaging, such as CT or cardiac magnetic resonance. Additionally, an electrophysiologist (EP) with expertise in implantable devices and a cardiac anesthesiologist should also be part of the team. Physicians with other subspecialty expertise, such as those trained in geriatric medicine or nephrology, may be included, too,.

In addition to the ACC and AHA, the American Society of Echocardiography, Heart Rhythm Society, and Society of Thoracic Surgeons were involved in writing the consensus report.

Balance Between Quality and Access

The document highlights core competencies required by all heart team members and key attributes of operators, programs, and institutions that offer TTVI, said Kumbhani.

“As with other transcatheter technologies, the framework aims to balance quality and access,” he said. In their document, the group lays out the voluntary volume requirements for creating TTVI programs. At the institutional level, these include:

• ≥ 50 open-heart surgeries in the previous year
• ≥ 20 tricuspid valve surgeries (isolated or combined) in the 2 years prior
• At least two physicians with cardiac surgery privileges
• At least one physician with interventional cardiology privileges
• One EP available for pacemaker implantation or lead extraction when needed
• ≥ 50 TAVI and ≥ 20 TEER procedures per year (or ≥ 100 TAVI and ≥ 40 TEER in the previous 2 years)
• ≥ 200 complete transesophageal echocardiograms (TEEs) performed per year (or ≥ 400 TEEs in the previous 2 years)

For operators performing TEER or TTVR, 50 or more career structural valve procedures (including ≥ 20 TEER procedures) are required to begin a TTVI program. The catheter operator should be board-eligible or -certified in either interventional cardiology or cardiothoracic surgery. For interventional echocardiographers, the same career volume requirements are advised. All doctors involved in the cases should receive device-specific training with TriClip, Evoque, or other devices that may potentially come to market. 

With TEER, the procedure should be performed by at least two physicians working together, with an interventional echocardiographer being one. For TTVR procedures, three physicians actively participate in each case: an interventional cardiologist, an interventional echocardiographer, and a cardiac surgeon. If the TTVR team consistently demonstrates that they can perform the procedure safely after 25 cases (or 3 years doing TTVR procedures), TTVR can be done with an interventional echocardiographer and either a surgeon or interventional cardiologist, say the experts.

It’s advised that sites perform 20 or more tricuspid valve interventions, of which 10 or more are TEER procedures, each year to maintain their TEER program (or ≥ 40 tricuspid valve interventions, of which ≥ 20 are TEER, over 2 years). With TTVR, sites are advised to do 20 or more tricuspid valve interventions annually. This should include at least 10 that are transcatheter cases, of which at least five are TTVR (or ≥ 40 over 2 years, with ≥ 20 being transcatheter and ≥ 10 being TTVR). For both TEER and TTVR, sites should continue to maintain their structural volumes, with 50 or more structural cases year (or ≥ 100 over 2 years) recommended.

“The program case volumes were determined by querying the STS Adult Cardiac Surgery Database and the STS/ACC TVT Registry, reviewing published experiences from other sources, and incorporating expert opinion from the societies and representatives involved in this document,” said Kumbhani. “Importantly, it lays emphasis on both volume and quality benchmarks.”

Tracking Quality in the STS/ACC TVT Registry

Compared with other valvular interventions, surgical outcome comparisons are unavailable and there is limited data on the effectiveness of medications. The data from observational registries and from the TRILUMINATE trial have shown that TEER is safe when performed by skilled operators, but the experts say it’s vital to continue to track safety endpoints. Evoque was approved based on data from TRISCEND II, and the risks of TTVR are higher than with TEER, but the same long-term surveillance is needed as the therapy moves into real-world practice.

The US Centers for Medicare & Medicaid Services (CMS) agreed to reimburse both under the coverage with evidence development (CED) process, which means that patients must be treated as part of a CMS-approved study. Mandatory reporting to the TVT Registry will “provide postmarketing surveillance and long-term outcome measurement for these therapies,” said Kumbhani.

The experts lay out numerous outcome and performance metrics to assess the quality of care. These include minimum quality standards of preprocedural processes of care, in-hospital and 30-day rates of all-cause mortality, and 30-day rates of procedural conversions, vascular complications, severe TR, rehospitalization for HF, and quality-of-life measures. One-year outcomes, including mortality, rehospitalization for HF, unplanned repeat reintervention, severe TR, significant tricuspid stenosis, and quality of life, should also be tracked and reported.

The writing committee also suggests tracking multiple in-hospital metrics to ensure high-quality TTVI, such as rates of technical success, repeat reintervention/explantation, major bleeding, cardiac complications, thromboembolic complications, unplanned need for mechanical circulatory support, cardiac arrest, adverse effects on a preexisting leads, device embolization, single leaflet detachment (for TEER), and paravalvular regurgitation (for TTVR).