New transcatheter tricuspid treatment options poised to drive surgical volume growth
The advent of new transcatheter tricuspid valve therapies, including transcatheter edge-to-edge repair (TEER) and total valve replacement options, is expected to improve treatment for patients with tricuspid valve disease and lead to an increase in surgical volumes. When transcatheter aortic valve replacement (TAVR) was introduced more than a decade ago, it unexpectedly boosted surgical volumes because of an increased number of patients referred for TAVR turned out to be better candidates for surgery. Early on in TAVR programs, the return on investment for starting a transcatheter valve program was ironically a boost in additional surgeries. The same trend is now being seen at some centers with tricuspid interventions.
"Since we were a part of the TRILUMINATE IDE trial from the beginning, and now we have the Evoque transcatheter valve replacement device cleared by the FDA, our tricuspid surgical volume has definitely picked up. And most of these patients we screen for transcatheter therapy first," explained Gilbert H. Tang, MD, professor in the department of cardiovascular surgery at the Icahn School of Medicine and surgical director of the structural heart program at the Mount Sinai Health System. He spoke to Cardiovascular Business in a video interview about this ongoing trend.
If a patient does not qualify for a transcatheter repair or replacement due to anatomy, age or surgical risk, Tang said they ask the surgeon on the heart team to evaluate the patient.
All patients sent to his valve center get a CT scan to look at the anatomy to see whether they are suitable for transcatheter repair. In the case of TAVR, if the patient is 65 or younger, Tang said they are recommended for surgery because of the durability standpoint. He said if a patient is expected to live another 20-30 years, they will likely need a second valve replacement. It is true that a patient can have a TAVR-in-TAVR to avoid surgery, but each valve gets smaller with the extra hardware, so a surgical replacement would then be needed after that. Because it is easier for younger patients to undergo surgery, Tang said it is recommended younger patients get surgery and then later in life they can get minimally invasive TAVR. He said similar considerations are likely for the tricuspid valve as well.
Tricuspid valve disease has a new era of interventions
For years, tricuspid valve interventions were often seen as high-risk or last-resort options due to the complexities of the anatomy and the patient population typically referred for treatment. However, the introduction of transcatheter therapies has begun to shift this paradigm. Tang said these therapies not only expand treatment options but also facilitate earlier referrals and evaluations, ultimately improving patient outcomes.
Tang explained that new transcatheter options, including the Abbott TriClip transcatheter edge-to-edge (TEER) repair system and the Edwards Lifesciences Evoque tricuspid transcatheter valve replacement (TMVR) system, are primarily targeted at patients who face an intermediate or high surgical risk. These tools allow for less invasive treatment of the valve, which can lead to improved organ preservation and faster recovery times for patients.
While the tricuspid has been referenced to as the "forgotten valve" in the past because there were few options for patients and surgical outcomes were not great, most tricuspid patients were not referred for surgery, or the patients said they did not want open heart surgery. Some surgeons have argued that previous studies may have pointed to poor outcomes, but the trials included extremely sick patients. That will likely change, however, and there is a good chance that more patients than expected will begin getting referred to structural heart centers because of the minimally invasive options.
Patient selection for tricuspid interventions and surgery
"Surgery is still on the table ... but it takes a team, holistic approach to decide which option is going to be best in terms of the transcatheter option, or whether it's repair versus replacement," Tang explained.
Often, he added, it all comes down to the patient's anatomy and the imaging results. Valve replacement may be considered if the imaging shows complex anatomy, for example, but this may also increase certain risks and put the patient in the hospital for a long period of time. These are some of the trade-offs heart teams must consider, he said, and they need to be discussed with the patient and the referring cardiologist in an open conversation.
To help in these discussions and enable better patient selection, Tang said the Society Thoracic Surgeons (STS) released a tricuspid valve surgery risk score in April 2024.
"That's kind of a benchmark based on the previous data they've collected over the decades. And also there's the TRI-SCORE that was published in Europe looking at the same kind of patients to try and risk stratify them based on different comorbidities or characteristics to see what options might be best from a procedural standpoint," Tang explained.
He said isolated tricuspid valve repair is actually very straightforward procedure, and it takes about 15 minutes to put in an annuloplasty ring. Tang said that is gold standard treatment in surgery.
"The caveat is that it's rarely done in most centers in the United States, except in our high-volume valve center. So as a result, we are very experienced in taking care of these patients before and after surgery," Tang said.
Tang said overall, there is a potential for these innovations to reshape the way tricuspid valve disease is managed in the United States, where surgical intervention for the tricuspid valve has historically been less common.