‘Sobering’ Adverse Event Rate With Evoque Seen in Real-world Use
Responding to MAUDE data, some have safety concerns but others aren’t surprised to see more events in higher-risk patients.

The number of adverse events reported with the Evoque transcatheter tricuspid valve replacement (TTVR) system (Edwards Lifesciences) during the first year of commercial use should put operators on high alert, say authors of a new research letter. This added scrutiny is especially important, they advise, when selecting patients.
Of 158 events reported to the US Food and Drug Administration’s Manufacturer and User Facility Device Experience (MAUDE) database in the 12 months after Evoque’s approval in February 2024, bradycardia and high degree atrioventricular (AV) block were the most common (44.3%), followed by device malposition, migration, or embolization (20.9%).
While it’s not possible to know the denominator—the number of Evoque cases performed over the study period—senior author Ron Waksman, MD (MedStar Washington Hospital Center, Washington, DC), told TCTMD it’s likely around 1,000, which translates to “a very high rate of events.” Even if 2,000 procedures were done in the US, the adverse-event rate would still be high, he said. “There is a signal here, and we just have to better understand what that means.”
Waksman acknowledged that it’s “fairly early” to assess real-world events for the device, given that they may be underreported to MAUDE and the data can’t take into account the effects of a reportedly steep learning curve. However, his team felt it was important to look at the numbers because Evoque was approved by the FDA on the basis of early data from the TRISCEND II trial without being reviewed in an advisory panel.
One-year results from the trial, presented at TCT 2024, showed significant improvements in quality of life with Evoque over optimal medical therapy, but the device did not reduce hard outcomes like mortality. Moreover, adverse events like severe bleeding and conduction disturbances requiring a new pacemaker or cardiac implantable electronic device were reported in 10.4% and 24.7% of TTVR-treated patients, respectively.
There is a signal here, and we just have to better understand what that means. Ron Waksman
TRISCEND II co-author Raj Makkar, MD (Cedars-Sinai Medical Center, Los Angeles, CA), however, said he’s not worried by the new report.
“I don’t think that there is anything alarming here, but at the same time, I think it is clear from all the data that we have—the TRISCEND data, the [early feasibility] data, and this data—that yes, these are the limitations or complications that are associated with this procedure, which we must keep in mind as we select our patients,” he told TCTMD. “It’s also important to remember in real life we [treat] patients that were excluded from randomized clinical trials and that are desperate for therapy. We will tend to push the envelope even a little bit more in real life because a lot of these patients have no choices.”
Neil Fam, MD (St. Michael’s Hospital, University of Toronto, Canada), who was not involved in the new analysis, agreed that less-stringent selection with real-world patients might be coming into play here. “I don’t know if the operators are pushing the limits of what can be treated because it is now commercially available,” he told TCTMD.
“Overall, it’s somewhat sobering and speaks to the fact we have to be very, very careful in patient selection,” Fam said. “Patients undergo TTVR and it’s not something necessarily that needs to be offered to all patients, particularly if other options such as TEER [transcatheter edge-to-edge repair], which is safer, could be considered.”
Closer Look at Events
For the study, published as a research letter last week in JACC, Lior Lupu, MD (MedStar Washington Hospital Center), Waksman and colleagues looked at 150 reports of 158 adverse events with Evoque that were reported to the MAUDE database between February 2, 2024, and February 1, 2025.
Among the 70 patients with bradycardia or high degree AV block, two died and 65 required permanent pacemaker implantation. About one-quarter of events (23.9%) were detected during TTVR, 37.3% were identified within 2 days, and 35.8% were found within 3 days to 3 months.
Device malposition, migration, or embolization occurred in 33 patients, six of whom died. Three-quarters of these events were diagnosed during the procedure, with 13.8% and 6.9% found within 2 days and 3 months, respectively. Ten of these cases involved a transcatheter valve-in-valve procedure (two with a second valve), two required transcatheter treatment of paravalvular leak, and 16 had surgery.
Twenty reports of leaflet thickening or thrombus were noted, 16 of which resulted in clinical or hemodynamic consequences. More than half of these events happened within the first month, and treatment included thrombolysis (n = 4), transcatheter valve-in-valve implantation (n = 2), and surgery (n = 1).
Cardiac tamponade and venous injury or bleeding were reported in eight patients each, resulting in four and two deaths, respectively. Also, there were five instances of ventricular tachycardia, fibrillation, or cardiac arrest and four reports of mechanical failure of the delivery catheter due to nose-cone separation.
Adverse events were most commonly reported in the fourth quarter of the study period (45.8%) and when 52-mm devices were used (44%).
Waksman said he was not surprised by the rate of bradycardia given what was seen in TRISCEND II, adding that “it’s really an issue that needs to be disclosed to the patient, that most likely he would need to get a pacemaker at some point.”
Also, the prevalence of device malposition demonstrates that implanting Evoque is not as straightforward as with other structural heart procedures, Waksman said. “It requires more training and being more careful about it.”
He called for more postmarketing surveillance data, “which the company is doing,” but also for making “the bar higher in terms of training” operators learning to use Evoque. “It should be of the same rigor it was in the clinical trial,” Waksman advised.
‘Not as Safe’ as TEER
Complications like AV block and bleeding, previously seen in TRISCEND II, are to be expected, Fam said, but he did not expect to see device malposition and embolization. Many of these events required “surgery, with very high mortality. I think that has a lot to do, probably, with center experience or the proctoring experience of the implanting team,” he said, adding that he’s never personally seen ventricular tachycardia or nose-cone separation, wherein the delivery catheter fails, with TTVR. “I don’t know if that’s a batch issue or what, but Edwards has to look into that further.”
Makkar, too, said he hasn’t witnessed a valve embolization in almost 90 patients treated with Evoque at his center and that procedure lengths, bleeding complications, and likely pacemaker rates have come down with time.
“I think it just speaks to the fact that TTVR is not as safe as doing a TEER with a clip type of procedure,” Fam continued. “But the trade-off is efficacy versus safety. I think what we’re seeing here is the safety signal.” He advised centers performing these procedures to monitor patients in the hospital for heart block for at least 5 days and to work on mitigating bleeding.
Similar data from Europe, where the device is also commercially available, would help “confirm or somewhat buffer” these findings, Fam said. “Hopefully we’ll be seeing 2-year follow up data, maybe later this year, which will either confirm efficacy or show that there’s a late safety signal. I don’t think there’s going to be a huge late safety signal with TTVR. I think all of the risk is front-loaded, and I think that’s why patient selection, procedural execution, and then postprocedure management in hospital are extremely important.”
Additional information from the TVT Registry will also give a valuable “snapshot” of what’s happening in the real world with this device, Makkar said.
“I have to tell you that this therapy is so dramatic in terms of abolishing tricuspid regurgitation and in terms of improving quality of life in a lot of our patients who have no other treatment,” he stressed. “For these patients to have this therapy, in my opinion, is actually extremely valuable.”
Yael L. Maxwell is Senior Medical Journalist for TCTMD and Section Editor of TCTMD's Fellows Forum. She served as the inaugural…
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Lupu L, Rogers T, Haberman D, et al. Adverse events reported for the Evoque transcatheter tricuspid valve replacement: a MAUDE database analysis. J Am Coll Cardiol. 2025;18:1489-1491.
Disclosures
- Waksman is an advisory board member for Abbott Vascular, Boston Scientific, Medtronic, Philips IGT, and Pi-Cardia; is a consultant for Abbott Vascular, Append Medical, Biotronik, Boston Scientific, JC Medical, MedAlliance/Cordis, Medtronic, Philips IGT, Pi-Cardia, Swiss Interventional/SIS Medical, and Transmural Systems; has received institutional grant support from Biotronik, Medtronic, and Philips IGT; and is an investor in Append Medical, Pi-Cardia, and Transmural Systems.
- Lupu reports no relevant conflicts of interest.
- Fam reports serving as a consultant to Edwards Lifesciences.
- Makkar reports receiving institutional research grants from Edwards Lifesciences.
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