Right Atrial Enlargement: Signs and Treatments

'Big Step Forward' For Transcatheter Tricuspid Valve Replacement: TRISCEND II

SAN FRANCISCO, CA—Patients with severe tricuspid regurgitation (TR) treated with transcatheter valve replacement experienced a significant improvement in TR grade and had "meaningful" improvements in functional status and symptoms, according to data from the first 150 patients in the TRISCEND II study.

These results were heralded as a big win for transcatheter tricuspid valve replacement given the good safety profile and near complete elimination of TR. Lead investigator Susheel Kodali, MD (NewYork-Presbyterian/Columbia University Irving Medical Center, New York, NY), said the results are welcomed because patients with severe, symptomatic TR don't have a lot of options.  

"The ones that tend to go for surgery are younger and healthier," Kodali told TCTMD. "The majority of patients with secondary TR are in their 70s and 80s. They are not getting operated on, and a number of series now have shown that their mortality is high."

Today during a late-breaking clinical trial session at TCT 2023, TRISCEND II investigators reported that roughly 10% of patients had a severe bleed—likely attributable to the need for anticoagulation—and 15% required permanent pacing. Still, the primary safety endpoint at 30 days—a composite of adjudicated major adverse events—was less than expected and deemed well within the acceptable threshold, according to investigators.

This device, unlike TEER, eliminates TR. Susheel Kodali

Neil Fam, MD (University of Toronto/St. Michael's Hospital, Canada), who performed the first-in-human transcatheter tricuspid valve replacement with Evoque (Edwards Lifesciences) more than 4 years ago, called TRISCEND II a "big step forward." Even back then, early outcomes looked good, but they've since gotten better.

"We were immediately impressed with the first 25 cases that were done [at multiple centers]," he told TCTMD. "There was no mortality and about an 8% or 10% rate of pacemaker [implantation]. Now you fast-forward to this randomized trial and the safety is actually improving compared with the TRISCEND I early feasibility study. Major bleeding has been cut nearly in half."

Similarly, Sam Dawkins, MD, PhD (Oxford University Hospitals NHS Foundation Trust and Cleveland Clinic London, England), said TRISCEND II was one of the most eagerly anticipated studies at the meeting.   

"This is quite an important group of patients," Dawkins told TCTMD. "We are able to offer transcatheter edge-to-edge repair, but there's a group of patients where you can't do that, such as in people with very large coaptation gaps, those with a very dilated annulus, or those with pacing leads that are splinting the valve open—that's quite a big group. Transcatheter edge-to-edge repair isn't in the cards for them, and surgery is very high risk and [infrequently performed]. A transcatheter tricuspid valve replacement device is treating a group for whom we have nothing."

Designated Breakthrough Device

In 2019, the US Food and Drug Administration deemed Evoque a "breakthrough" therapy to help facilitate patient access (it is not yet approved in the US, but received CE Mark approval in Europe just last week). The TRISCEND II study, which will ultimately include 400 patients, was devised to allow for analysis of these first 150 patients randomized in the study.

Patients were approximately 79 years old, and nearly 80% were female. The mean STS score—used to estimate risk of mitral valve surgery given the absence of a tricuspid surgery risk score—was roughly 10%. Nearly all patients had atrial fibrillation at baseline and 35% to 40% had a preexisting pacemaker/implantable cardioverter defibrillator. More than 77% of patients undergoing transcatheter tricuspid valve replacement had secondary TR.

In the Evoque/optimal medical therapy (OMT) arm, 43.8% had severe TR at baseline, 21.9% had massive TR, and 34.4% had torrential TR. In the OMT-alone group, severe, massive, and torrential TR was present at baseline in 40.7%, 27.8%, and 31.5% of patients.

A transcatheter tricuspid valve replacement device is treating a group for whom we have nothing. Sam Dawkins

At 30 days, the primary composite safety endpoint occurred in 27.4% of the 95 patients treated with transcatheter valve replacement, a rate that compared favorably with historic safety data after tricuspid valve surgery (43.8%). Severe bleeding (10.5%) and the need for permanent pacing (14.7%) were the two most commonly adjudicated adverse events. There was a single case of device-related pulmonary embolism. Cardiovascular mortality was 3.2%.

At 6 months, transcatheter tricuspid valve replacement "virtually eliminated" TR, according to investigators. Overall, 98.8% of patients had moderate or less TR and 93.8% had mild or less. Nearly 78% had none/trace TR. With OMT, just 21.6% had moderate or less TR, with more than 50% continuing to have massive or torrential regurgitation.

Improvements in quality of life and functional status, assessed as a hierarchical composite endpoint that measured changes in Kansas City Cardiomyopathy Questionnaire (KCCQ; ≥ 10 points), NYHA functional class (≥ 1 class), and 6-minute walk test distance (≥ 30 meters), were superior with transcatheter tricuspid valve replacement (win ratio 4.6).

The difference in the mean change in KCCQ score compared with OMT was 17.8 points, while the mean difference in distance with the 6-minute walk test was 30.9 m. Additionally, 90.0% of patients treated with Evoque/OMT had NYHA I/II symptoms at 6 months compared with 34.2% of those treated with OMT alone.

Mortality 'Very Encouraging'

To TCTMD, Dawkins said that one of the challenges with transcatheter tricuspid valve replacement is that transcatheter edge-to-edge repair (TEER) is "spectacularly safe." In TRILUMINATE, for example, the 30-day mortality rate was 0.6% with TriClip (Abbott) in a group of patients with extensive comorbidities.

"Now, tricuspid replacement is a higher-risk proposition than repair, but that has to be put into context with the terrible outcomes of severe tricuspid regurgitation," he said. "They really don't do well. I was encouraged in TRISCEND II to see that 30-day mortality was low in a very comorbid patient population: 3% mortality for tricuspid replacement for such comorbid patients is very encouraging."

The learning curve with implantation is straightforward, said Kodali, calling it a "trainable, teachable procedure." Imaging with valve replacement is less important than with TEER, he said, as operators don't need to visualize the leaflets as closely. "That's part of the shortening of the learning curve," he said, "because the learning curve is not just the interventionalist but the entire team, [including] the imager."

The possibility of permanent pacing remains the Achilles' heel with transcatheter tricuspid valve replacement, said Fam, noting that while a rate of 15% in TRISCEND II doesn't sound high, these conduction disturbances are unpredictable.

"With TAVI, we have very clear predictors about who's going to get heart block and we have strategies to mitigate that," he said. "With [transcatheter tricuspid valve replacement], ideally it happens in the hospital, but the worst is when they go home and develop syncope and heart block and you have to try to get them back in." 

To counter those risks, patients are frequently sent home with 14-day Holter monitoring, he said. "Future strategies are to iterate devices to make them softer, with less radial force in the annulus, where the anchors are not as aggressively digging into the septum where the conduction system lies," said Fam.

To TCTMD, Wayne Batchelor, MD (Inova Heart and Vascular Institute, Falls Church, VA), said that it can be challenging to deal with pacing leads in patients undergoing transcatheter valve replacement. If they have a preexisting device, the leads can be jailed with the replacement tricuspid valve, and it can also be difficult place a lead after the valve has been implanted. He is hopeful that that advances in leadless pacemaker technology might provide a solution.    

Mortality or Patient-Reported Outcomes

With the full TRISCEND II patient population, investigators will take a look at harder clinical endpoints, with the 1-year composite endpoint including all-cause mortality, need for right ventricular assist device/heart transplant, need for tricuspid valve surgery or intervention, heart failure hospitalization, and KCCQ/NYHA functional class/6-minute walk distance.

One of the major questions going forward with transcatheter tricuspid therapies—whether that's repair or replacement—is whether patient-reported outcomes, such as quality of life, should be enough to drive device approval and reimbursement. During a TCT 2023 FDA Town Hall, Suzanne Arnold, MD (Saint Luke's Mid America Heart Institute, Kansas City, MO), and Nir Uriel, MD (NewYork-Presbyterian/Columbia University Irving Medical Center), debated this very topic, with Uriel pointing out that the limitations in patient-reported outcomes become magnified in unblinded studies.

"Quality of life from a patient perspective is an important outcome," Kodali told TCTMD. "The question of how you control for placebo in these trials, without a sham control, is a consideration. We have to acknowledge that there is going to be some component of a placebo effect."

While a sham-controlled trial would be ideal, it's not likely feasible in these type of device trials as it would be difficult to maintain blinding for 12 months or longer, he said. Additionally, undergoing transcatheter tricuspid valve replacement requires anticoagulation, raising issues about administering anticoagulation to a placebo group.

Regarding clinical events, Fam said there are data showing that improvements in KCCQ scores in patients with severe TR track with a lower risk of death and heart failure hospitalizations. "If you read the tea leaves, the longer you follow these patients, maybe we'll see some change in hard outcomes," said Fam. He pointed out, like others, that quality of life is a very valid endpoint in these patients.

"As cardiologists, we're all obsessed with death and heart failure, but in the end, the only patients I see in my practice who can stop diuretics and feel great are [transcatheter tricuspid valve replacement] patients," he said. "That means a lot for them." The improvement in quality of life, Fam added, is on par with the benefits seen with TAVI.   

Dawkins believes a quality-of-life benefit should be enough to see the device approved in more countries, including the US, and to be reimbursed. "There are very few medical interventions that have a mortality benefit," he said. "I personally don't think we need to set bar as a high as that. I do think if we identify the right group of patients, we will find a mortality benefit, but there are a lot more who stand to benefit from quality-of-life improvements."

Kodali thinks researchers, along with regulators, should assess the totality of evidence to get a handle on replacement's advantages. They'll want to see individual endpoints trending in the right direction, including not only mortality and heart failure hospitalizations, but also RV remodeling and size. "The severity of TR affects impacts 1- and 2-year survival in population studies," he said. "This device, unlike TEER, eliminates TR. Whether that elimination of TR will translate into an improvement in mortality is what we need to see at 1 year—we hope it does."

He speculated, though, that in order for a reduction in hard clinical endpoints to be seen, they might need to follow patients for longer than 1 year or to include even sicker patients.

Roxana Mehran, MD (Icahn School of Medicine at Mount Sinai, New York, NY), who moderated the TCT press conference, believes that for transcatheter tricuspid valve replacement to gain approval, researchers will need to demonstrate a clinical benefit, even if it's a reduction in heart failure hospitalizations. While improvements in quality of life are important, she said, that should be placed in the context of reduced clinical events.

Tricuspid Clip Might Work For More Patients Than Thought

SAN FRANCISCO -- Tricuspid transcatheter edge-to-edge repair (T-TEER) performed better than anticipated in patients expected to have only a modest benefit due to more complex anatomy, the TRILUMINATE trial showed.

After receiving the investigational TriClip device to hold the leaflets together, most patients enrolled in the single-arm portion of the trial as a result of their complex anatomies -- presumed to preclude a reduction in tricuspid regurgitation (TR) to moderate or less -- actually achieved that grade of regurgitation.

At 30 days, 40% dropped from severe or worse TR to moderate TR and 40% had trace or mild TR. "Equally remarkable," those rates were maintained (43% and 38%, respectively) at 1 year, David Adams, MD, of the Icahn School of Medicine at Mount Sinai in New York City, reported at the Transcatheter Cardiovascular Therapeutics (TCT) meeting.

"In retrospect, we're not very good at predicting the magnitude of TR reduction in tricuspid TEER in more complex scenarios," he said at the session.

TriClip probably isn't the answer for everyone, he said. "I'm hoping that one day we will have a portfolio of ways to do repair and replacement of the tricuspid valve in these patients. But I think our pool of potential clip candidates has expanded based on the data I've shown today."

The proportion achieving moderate or less TR in the single-arm trial (81%) was similar to the 89% in TriClip-treated patients in the randomized portion of the trial with more favorable anatomy, although the latter group achieved more mild or trace TR.

Quality of life score improvements on the Kansas City Cardiomyopathy Questionnaire (KCCQ) were similar as well.

Survival through 12 months with at least a 10-point gain over baseline in KCCQ score met the primary endpoint performance goal in that arm with a rate of 46.2% (P=0.0008) despite the more anatomically complex population in the single-arm cohort.

Adams also presented outcomes for the full 589 patients randomized in the trial, with similar findings compared with the data on the first 350 that was released earlier this year. One change was that the improvement in 6-minute walk distance achieved significance in imputed and paired analysis it didn't have in the smaller dataset.

TriClip still didn't improve 12-month freedom from mortality or tricuspid valve surgery (90.1% vs 90.3%). But the proportion with at least a 15-point gain in KCCQ score was preserved, so the additional patients strengthened the primary endpoint of those endpoints plus heart failure hospitalization in a Bayesian analysis with a win ratio of 1.53 compared with medical therapy alone (95% CI 1.14-2.05).

"Data from all randomized subjects in the TRILUMINATE pivotal trial strengthen the conclusions of the previously reported primary cohort analysis," Adams said.

In a separate analysis of the initial 350 randomized patients diving deeper into the quality of life findings, Suzanne Arnold, MD, MHA, of Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City, reported a number needed to treat of 3.5 for one additional patient to be alive and well at 12 months.

"Exploratory analyses suggested that much of the health status benefit of T-TEER could be explained by TR reduction and that improvement in health status after T-TEER was strongly correlated with reduced 1-year mortality and heart failure hospitalization," her group wrote in a paper simultaneously released in the Journal of the American College of Cardiology.

Still, TCT session study discussant Gorav Ailawadi, MD, of the University of Michigan in Ann Arbor, noted that these findings didn't quite measure up to what might have been expected from mitral valve TEER with MitraClip.

"We were overwhelmed by how good COAPT was; we're not quite seeing that same level of overwhelming success although we're now starting to see a signal [of benefit with TEER]," he said. "Obviously the results with functional TR, as most of these patients are with TEER therapies, are not the same with tricuspid as they are with mitral."

Adams agreed that it's becoming clear that right sided valve disease is very different than left sided valve disease. "And we probably were a bit naive in thinking we would see mortality benefits at 1 year," he said. "We don't take a patient to the operating room and promise them they'll live longer in 1 year if we do a tricuspid valve operation. And by the way, survival is not mentioned in the ACC/AHA [American College of Cardiology/American Heart Association] guidelines indication for tricuspid valve intervention. So I think we've got to sort of start rethinking the expectation."

Arnold agreed but acknowledged one challenge: "Even if we're not seeing clinical hard endpoints, I think that making patients feel better is an incredibly important goal. And so I think with some of these open label trials, we just have to figure out how do we prove that it's real? How do we prove that improving patient's health status is not just a placebo effect?"

One big concern is that there's no information about the blinding of the patient to their echocardiographic finding at the time of completing the KCCQ, as the echo and KCCQ likely happened at the same visit.

"I'm concerned about those correlations and the unblinding of a patient knowing that their echo looks good. The tech might tell them, 'Oh, the echo looks good. You have less.' And then they take the KCCQ," said TCT press conference moderator Roxana Mehran, MD, of the Icahn School of Medicine at Mount Sinai in New York City.

"If we want to validate these patient-reported outcomes, they have to be separated from other endpoints that could unblind or bias the results of a KCCQ," she said.

One thing that is reassuring in that respect was that patients who had the most reduction in tricuspid regurgitation garnered the greatest benefit in terms of quality of life, commented Wayne Batchelor, MD, of the Inova Heart and Vascular Institute in Falls Church, Virginia, a panelist at the press conference.

"We're starting to peel the onion a little bit and get a glimpse of how this could be biologically connected," he said. "I think the missing pieces now are the mechanistic links. So it'd be very interesting to see how this relates to changes in RV [right ventricular] modeling."

Disclosures

The trial was sponsored by Abbott.

Adams disclosed that his institution receives royalties from Edward Lifesciences and Medtronic in connection with his intellectual property related to mitral and tricuspid valve repair rings.

Arnold disclosed no relevant relationships with industry.

Ailawadi disclosed relationships with Abbott, Medtronic, Edwards Lifesciences, W.L. Gore & Associates, Philips, JenaValve, Anteris, AtriCure, CryoLife, Johnson & Johnson, and Arthrex.

Primary Source

Transcatheter Cardiovascular Therapeutics

Source Reference: Adams DH "TRILUMINATE Pivotal: Outcomes of all randomized and the single-arm subjects with transcatheter tricuspid valve edge-to-edge repair for tricuspid regurgitation" TCT 2023.

Secondary Source

Journal of the American College of Cardiology

Source Reference: Arnold SV, et al "Health status after transcatheter tricuspid-valve repair in patients with severe tricuspid regurgitation: Results from the TRILUMINATE pivotal trial" J Am Coll Cardiol 2023; DOI: 10.1016/j.Jacc.2023.10.008.

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TRILUMINATE Deep Dive Clarifies 'Meaningful' QoL Gains With Tricuspid TEER

In patients with severe tricuspid regurgitation (TR), transcatheter edge-to-edge repair (TEER) using the TriClip system (Abbott) substantially improves patient symptoms, functional status, and quality of life (QoL) through 1-year, according to new in-depth data from the TRILUMINATE pivotal trial.

The findings, presented in a late-breaking clinical trials session today at TCT 2023, follow data from the same trial presented earlier in the meeting showing 1-year safety and efficacy of the procedure in additional patients randomized to TEER or medical therapy alone as well as those with complex anatomies treated with TEER.

"The results really do support that tricuspid TEER probably does improve the health status of patients, and I think it's just a matter of trying to find who are the right patients—who are the ones who are symptomatic from their TR who are going to be most likely to benefit—and targeting to those," Suzanne V. Arnold, MD (Saint Luke's Mid America Heart Institute and University of Missouri-Kansas City, Kansas City, MO), who presented the findings, told TCTMD.

Suzanne Baron, MD (Massachusetts General Hospital, Boston), who discussed the findings during the session, said, "This study adds to the growing body of literature that transcatheter edge-to-edge repair, either in the mitral or tricuspid position, really does result in significant and clinically meaningful improvement in quality of life for these patients."

Commenting on the study for TCTMD, Dee Dee Wang, MD (Henry Ford Health System, Detroit, MI), said, "The most important takeaway is that there is clinical benefit.". However, she added, "we are learning about the right-heart pathophysiology and tricuspid regurgitation as we are doing these clinical trials, and we may not have all the correct endpoints for the right heart."

Because of this, past studies "may not be truly showing the benefit of transcatheter therapies in the right heart," Wang continued. "It was great that this is the first study that is looking at KCCQ scores and quality of life. It is really about what patients want. Is their goal to run a marathon or is their goal to basically get up out of a chair and be independent and be able to take care of themselves and be in their own house on their own?"

The study was simultaneously published in the Journal of the American College of Cardiology.

QoL Endpoints

For the study, researchers looked at the first 350 patients with severe TR randomized in TRILUMINATE to tricuspid TEER (n = 175) or medical therapy (n = 175).

At 1 month, patients treated with TEER saw significantly improved health status as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ) compared with those on medical therapy alone (mean between-group difference 9.4 points), with a small additional improvement seen at both 6 months (mean between-group difference 11.2 points) and 1 year (mean between-group difference 10.4 points).

Additionally, those in the TEER arm were more likely than those in the medical therapy cohort to be alive and well at 1 year (defined as KCCQ-OS ≥ 60 and no decline from baseline of > 10 points; 74.8% vs 45.9%; P < 0.001), with a number needed-to-treat of 3.5 patients. The benefit of TEER went down with increasing baseline KCCQ-OS (P for interaction < 0.001).

"Patients with worse health status at baseline were the ones most likely to benefit," Arnold said.

In exploratory analyses of all patients from the TRILUMINATE Pivotal trial, including those enrolled in the trial's single-arm portion, much of the health status benefit seen with TEER was tied to reductions in TR, with every one-grade improvement in TR seen from baseline to 1 year associated with about a 4.1-point increase in KCCQ. This was also strongly correlated with lower rates of mortality and heart failure hospitalization at 1 year.

"Though we cannot fully exclude responder bias or even the placebo effect, the exploratory analysis suggests that the observed health status improvement is at least partially biologically mediated," Arnold concluded. "So we think that these results support the use of [tricuspid] TEER for improvement of symptoms, functional limitations, and quality of life."

'Substantial' Improvements

Patient-centered endpoints are powerful in people with TR, who tend "to prioritize quality of life over quantity," Baron said. "The fact that you found a mean difference in improvement between treatment groups of 10-11 points on the KCCQ overall summary score between TEER and medical therapy is substantial." For context, she said that empagliflozin (Jardiance, Boehringer Ingelheim/Eli Lilly) and sacubitril/valsartan (Entresto; Novartis) have only been associated with mean differences in the KCCQ score of one to two points and cardiac resynchronization therapy has been associated with about eight-point gains.

"It's also important to note that on the categorical analysis, over 50% of patients treated with TEER had that 10-point or more improvement translating to that incredibly low number of patients needed to treat," Baron added. "There are very few interventions in the heart failure arena that can boast that."

However, she questioned the discrepancy between the main findings, which did not demonstrate a reduction in death or heart failure rehospitalization, and this analysis, which showed that an improvement in KCCQ was significantly correlated with a reduction in these hard endpoints.

The explanation for this is likely multifactorial, according to Arnold. First, the event rate seen in the study was low, especially compared with that observed with patients with left-sided valve disease or heart failure. Also, she said, large health status improvements were not reported for all the patients in the trial. "This really highlights the importance of targeting the treatment to those who are most symptomatic because not only are those the ones that are most likely to benefit terms of symptoms to quality of life, but those are also potentially the patients who we may be able to affect in terms of clinical events there going forward," Arnold said.

Adding on, panelist Anita Asgar, MD (Montreal Heart Institute, Canada), noted that TR patients in general can be hard to identify in clinical practice. "They do not often come in with shortness of breath but they do come in with fatigue, peripheral edema, they come in with ascites when they are quite severely progressed," she said, questioning whether the KCCQ should be used more routinely by clinicians. "We struggle sometimes to really identify if a patient is symptomatic or not."

Agreeing, Arnold endorsed greater uptake of the KCCQ score in clinical practice precisely because of this challenge. "If ever you look at NYHA versus KCCQ, there is a huge amount of discrepancy among providers even assessing the same person in the same day," she said. "If we can find a way to use this not only to find the symptomatic patients, but also to assess their response to therapy, I think that would be really important because it is important to follow these patients after intervention because some of them don't improve."

Challenges Ahead

"Certainly, these findings are very promising, and we are seeing clinically that patients do feel better, but the number one question comes down to patient selection and anatomical selection," Wang said. "TRILUMINATE is ahead of its time. It was enrolling already when we knew very little about right heart anatomy and we were looking at TR. . . . We will get much better algorithms with time.

It is really about what patients want. Dee Dee Wang

Speaking during a TCT press conference, Wayne Batchelor, MD (Inova Heart and Vascular Institute, Falls Church, VA), called the findings "really valuable." But the question remains of whether there is any placebo effect at play, he said. "We are starting to peel the onion a little bit and get a glimpse of how this could be biologically connected. I think the missing piece now are the mechanistic links. It would be very interesting to see how this relates to changes in RV remodeling."

Also speaking to the media, Yousif Ahmad, MD, PhD (Yale School of Medicine, New Haven, CT), commented that the placebo effect is unlikely to be consequential here. "It's reassuring that the delta is maintained up to 1 year," he said. "I think if there was a placebo effect, you might see attenuation."

Roxana Mehran, MD (Icahn School of Medicine at Mount Sinai, New York, NY), who moderated the press conference, questioned what might have happened when the patients were unblinded to their echocardiographic findings, before or after deployment of the KCCQ. "I am concerned about those correlations and . . . The tech might tell them the echo looks good, and then they take the KCCQ," she said.

Arnold replied that this granularity wasn't captured in the study. "We assume that the patient would come in for their visit and would have the KCCQ done at the same time around the time of their echo," she said. "We don't know at what time the echo results were delivered to the patient. We do know that there were some differences between core lab and site related echos. So, they didn't know exactly what their TR was, but that's certainly a limitation."

What's Next?

Experts at TCT 2023 seemed to agree that with so much new data on transcatheter tricuspid therapies—TRISCEND II was presented in the same session—what comes next is both exciting and unknown.

"The improvement in the last few years has been amazing," Josep Rodés-Cabau, MD (Laval University, Quebec City, Canada), told TCTMD. "Having done now many cases with these systems—either repair or replacement—honestly, the learning curve I think has been done and the problem is imaging in some cases. It is very difficult to see well the leaflets, where we are clipping, and to me, this is the most important challenge."

Wang agreed, noting the important role imagers play in these procedures. "I hope that when the clinical trials come to fruition for commercial scalability, that the industry will make sure that interventional-imaging physicians will be listed at the same level as a co-investigator, not as a subinvestigator, and that the interventional imaging physicians will be listed as a co-operator required for this procedure," she said. "That is the only way they can scale these procedures."

Refining patient selection will also be directly tied to the success of this field, argued Ahmed. "I don't think we yet understand how to choose between the therapies. I think that's going to be very important," he said.

Further, Batchelor said, "understanding the relationship between these various therapies and pacemaker leads is very important. A lot of these patients have pacemakers to begin with, and . . . We know that those patients are more difficult to treat in terms of repair. And I think understanding that dynamic and also what happens when you put either a clip on or you replace a valve and the patient later on needs their lead replaced."

Ultimately, Arnold said that proving improved quality of life with these procedures is an important goal. "Focusing too much on the clinical outcomes I think is a disservice to the patients, who at the end of the day, yes, they want to be alive and they want to be out of the hospital, but they want to be functionally independent, they want to feel better," she said. "Especially with the tricuspid patients, that's really where I think we have the most ability to [have] impact."

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