Tricuspid Brinkmanship: Are We Overhyping the Right-Sided Revolution?

The Hype Train Has Left the Station… But Where’s the Track?

The tricuspid valve is having a moment; it’s no longer cardiology's wallflower, it's the toast of the town, sparking dreams in cath labs and boardrooms alike. Once an overlooked oddity, it now stars in high-octane studies like TRILUMINATE and TRISCEND II, igniting debates on whether tricuspid repairs (and replacements) are the next big wave or just a tempest in a teapot. But let's not pop the champagne just yet. Are we gearing up for a breakthrough, or setting the stage for a high-stakes fizzle, reminiscent of earlier transcatheter misadventures? The unique challenges of right-sided heart anatomy (and hemodynamics) demand more than a cursory glance. So, before we toast to the "right-sided revolution," we need to ask: Is this genuine progress or just a game of medical Jenga?

Join me as we peel back the layers of hype, examining these trials from all angles: industry, patients, regulators, and payers. Let's sift the real from the hype and see if these interventions will deliver on their grand promises, or if they're destined to be engulfed by their own hubris.

Advancing tricuspid innovation is a bit like sending a rover to Mars;
exciting, expensive, and everyone’s watching to see if it’ll crash.

Heart Valve: When It Flunks the Tight-Seal Test

Tricuspid Regurgitation (TR), or as I like to call it, "the leaky valve fiasco," is when your heart's tricuspid valve is more about freedom than control, letting blood flow backward when it should be moving forward. Picture this: In Functional TR or the "Heart-strain leak," the heart’s chambers are like overpacked suitcases, stretched from the inside and struggling to zip up tightly, heart failure being the usual culprit. On the flip side, there's Degenerative TR or "Wear-and-tear leak," where the valve is just tired from years of service, weathered down by age, or perhaps an infection, and not sealing like it used to. Figuring out whether your valve is overwhelmed by pressure or just a tired old gatekeeper helps zero in on how to patch things up, or when to call for backup.

Industry Ambitions vs. Clinical Realities: Striking a Perilous Balance

Surge of Enthusiasm
The tricuspid market is the new El Dorado for device manufacturers, offering vast prospects for those aiming to fix the infamous "leaky valve fiasco." Much like the gold rush days of early TAVR, there’s a fortune to be made for devices designed for patients previously written off.

Cautionary Tales
Yet, history serves up a reality check as icy as a clinical cold room: what sparkles in trial settings often dulls under the intense scrutiny of real-world applications. The diversity of patient populations and the whimsical nature of TR grading can turn controlled environments into wild cards. Today's petite trials, with their cherry-picking finesse, resemble more of a magician’s parlor trick than a steadfast scientific endeavor. We risk swapping rigorous validation for a credibility clearance sale.

Bottom Line: Manufacturers are betting big, but the true jackpot lies in backing bold claims with solid, incontrovertible evidence. Without it, they gamble not just with fortunes but with lives, and in the high stakes game of heart health, the final call will always demand hard proof over hype.

Tricuspid devices are like teenagers full of potential and bluster, but can they really clean up their act when put to the test?

Parsing the Triumphs and Tensions

TRILUMINATE: A Masterclass in Smoke and Mirrors?

The star of today’s show is TRILUMINATE, featuring 600 volunteers in a spectacle comparing transcatheter edge-to-edge repair (with the TriClip) to standard medical therapy. The headliner (primary endpoint)? A composite endpoint of mortality, surgeries, hospitalizations, and everyone’s favorite subjective measurement i.e., quality of life improvements via KCCQ. Surprise! The only “win” came from subjective patient questionnaires. Death? Surgery? Hospitalizations? Crickets. The results glow brightly, but only if you're measuring the applause meter, not the survival rate. 

We didn’t save lives, but hey, patients felt better! Maybe it was the clip… or maybe it was the placebo effect. Who cares? …Win ratio!

If feeling better is enough, maybe we should prescribe spa days instead of clips.

The TRILUMINATE imaging sub study adds precious little since firstly, all blinding is out of the window as the clip is clearly visible and secondly, it lacks hard outcome benefits.  

What’s missing? A placebo act. That's right, no dummy run. This study compared transcatheter edge-to-edge repair with the TriClip system to… checks notes… pills. Yes, pills. Surely, nothing screams “scientific rigor” like pitting a $30K device against prescription pills.  Evaluating an invasive procedure without a placebo control is like judging a magic show based solely on the magician’s charisma rather than his tricks. The outcome dazzles the naive but leaves the skeptics wanting.  

A Flicker of Reality: The PASUTA Registry

Not all is lost in the realm of observational studies. The PASUTA registry offers a sliver of real-world data with 1,000 patients showing some benefits from the newer gadget on the block (Pascal device).  The registry included consecutive patients, which is a strength, as voluntary registries often exclude unfavorable cases. For results, clinical outcomes remain meaningless without a control arm and complications were underreported (“no major complications” is rather vague). Once again, without a control group, it’s like relying on audience cheers to gauge a film’s Oscar worthiness. It's nice to hear, but where's the critical acclaim?

Let’s not forget that registry studies can describe trends but cannot prove effectiveness. 
Imagine the insights if these 1,000 patients had been randomized with a sham control arm!

TRISCEND II: When “Innovation” Means Trading Bleeding for Surveys

Then there’s TRISCEND II, which feels like a rerun of a show you didn’t want to watch the first time. If TRILUMINATE was a magic trick, TRISCEND II is the encore where the rabbit gets eaten by the hat. It follows the same script; big promises based on subjective quality-of-life scores, with no significant impacts on the endpoints that actually matter: death and hospital stays. But wait, there’s more: a 3X increase in bleeding and a need for 9X more pacemakers (because who doesn’t love a side of lead extraction?). Remember these involved specialized coronary sinus leads or leadless pacemakers. Talk of residual risks…and costs. If complications were dollars, we’d all be millionaires.

Moving on, this rerun focuses solely on quality-of-life data; unsurprising, as it’s the only positive aspect. My critique remains unchanged: Without placebo controls, these trials are scientifically inadequate.

 If complications were confetti, this trial would be a parade.

Tricuspid "Fixer-Upper": When the Cure is a Cardiac Backstab

Here’s the cold truth: Mending a leaky tricuspid valve is like silencing a smoke alarm while the house burns down. Sure, transcatheter gadgets stop the drip but they might also drop a hemodynamic anvil on the right ventricle. That cozy, low-pressure right ventricle (RV) gets sucker-punched by afterload whiplash and it’s not a mere hiccup.  It is a cardiac horror show. We’re not just fixing valves; we’re playing Jenga with anatomy. Yank one wobbly block (regurgitation), and the tower (RV function) collapses. The result? A “cure” that’s less miracle and more “Oops, we turned your heart into a ticking time bomb.”

Before slapping “revolutionary” on every catheter-delivered widget, remember: The heart isn’t LEGO. Nuance isn’t optional, it’s the line between hero and “RV Failure: The Director’s Cut.”

Science: Nothing But Roadkill on The Highway to Innovation

Once a device hits the market and CMS starts writing checks, clinical equipoise doesn’t just vanish, it’s vaporized by the thermonuclear blast of corporate momentum. The moment reimbursement codes drop, rigorous trials go from “ethically essential” to “commercially irrelevant.” Why? …because in today’s healthcare ecosystem, approval isn’t a scientific milestone, it’s a fiscal finish line.

Imagine this: You’re a researcher trying to run a sham-controlled trial for a device already plastered on billboards and touted by “key opinion leaders” wearing sponsored lab coats. Good luck recruiting patients who’d willingly risk getting the placebo when Dr. Instagram already told them the device is “revolutionary.” The scientific method? More like the scientific meth-head desperate, erratic, and chasing the next quick high.

Take TRILUMINATE and TRISCEND II, poster children for this farce. These trials didn’t just bend the rules; they snapped them over a knee and tossed the pieces into a quality-of-life survey bonfire. Once CMS reimburses these devices, future trials won’t ask, “Does this work?” They’ll ask, “How fast can we upsell?”

The tragedy isn’t just lost data, it’s medicine’s Faustian bargain: trading long-term knowledge for short-term revenue. Maybe we’re practicing faith-based billing, where the dogma is written by whoever owns the patent.

Sometimes the road to hell isn’t paved with good intentions, it’s reimbursed by CMS.

Patients on the Precipice: Hope, Hype, and the Real World

A New Lifeline
For those grappling with severe TR, often aged, frail, and saddled with other health woes, these devices herald a new dawn. Dodging the severe risks of open surgery is no trivial feat, and early whispers of enhanced life quality are indeed persuasive.

Reality Check
The patient in the clinic seldom mirrors the 'poster child' of clinical trials. Advanced RV dysfunction and complex conditions frequently throw cold water on the grand promises of transcatheter tricuspid valve interventions. Despite the orchestrated perfection of trial settings, the real world is messier, its patients less forgiving. Manufacturers, driven by tales of unmet needs, push for wide indications at the regulatory gate, only to see early successes dwindle when faced with the gritty reality of clinical practice. This mismatch sets the stage for a drama where initial victories fade, payers wrestle with ballooning costs, and ultimately, the entire healthcare system is left holding the bag. The critical need for better trial design, sub-group analysis and comprehensive follow-up has never been clearer, to ensure that the fleeting brilliance of clinical trial success isn’t overshadowed by the long-term challenges that follow.

Question to Ponder: Will real-world data reveal that those with significantly dilated right ventricles experience markedly different outcomes from the general trial population?

For patients, these new tricuspid devices promise a revolution; let’s hope it’s not merely a flash flood leaving no escape.

Raising the Stakes: The Regulator’s Uncompromising Gaze

As a former regulator in the EU battlefields, I’ve watched as gatekeepers elevate standards for clinical evidence, particularly when it comes to novel transcatheter cardiovascular devices.

• Safety and Durability: The unique dynamics of right-sided circulation present formidable hurdles. Early studies, while optimistic, rarely paint the full picture of long-term success.
• Post-Market Oversight: Armed with stricter regulations like the EU’s MDR and an increased focus on real-world evidence from the FDA, the watchdogs of our industry demand vigilant, ongoing surveillance post-approval.

Reality Check: Regulators must remain unswayed by sheer enthusiasm. Approval should hinge on a mosaic of data, from randomized trials where possible, to extensive registries and relentless follow-ups.

Regulators walk a tightrope, balancing the thrill of innovation against the gravity of evidence. Their scrutiny is the crucible in which true breakthroughs are forged or forgotten.

Payer Calculus: Proving Value Beyond the Hype

Payers, be they private insurers or public health custodians, cast a jaundiced eye on expensive new therapies. They demand incontrovertible proof of cost-effectiveness, fewer hospital stays, and genuinely better patient outcomes.

• Cost-Effectiveness: Do these interventions stand up to economic scrutiny compared to conventional treatments, especially among the heavily burdened patient populations?
• Value-Based Care: As the landscape of healthcare compensation evolves, manufacturers must prove beyond a shadow of a doubt that tricuspid innovations not only enhance outcomes but do so cost-effectively to secure both reimbursement and broader adoption.

Bottom Line: Absent compelling economic evidence, even the most groundbreaking technologies may find themselves on precarious footing. Can we afford to advance without solid proof, or are we gambling with the health system’s solvency?

Payers stand as the final gatekeepers, where the rubber meets the road. If the road is paved with uncertain evidence and unverified claims, are we driving the value conversation into a cul-de-sac?

Frontiers of Right-Sided Innovation: Bold Visions, Lingering Questions

Despite the thick fog of skepticism, the horizon for tricuspid therapy hints at a radical shift. Upcoming innovations may include:

• Refined Patient Selection: Sharper criteria that distinguish between various grades of TR, severe functional and degenerative TR types.
• Technological Improvements: State-of-the-art delivery systems, innovative repair techniques, and superior imaging protocols to streamline procedures and minimize complications.
• Conduction System Concerns: The proximity of right-sided devices to the heart’s electrical system poses risks that demand innovative solutions for potential pacemaker integration or the avoidance of conduction disruptions.
• Global Policy Alignment: Regulators worldwide are likely to tighten the reins on evidence requirements, compelling companies to elevate their game in trial design and post-market follow-through.

As we venture into these uncharted waters, are we navigating with precision, or are we adrift on assumptions? The echo of initial successes should not drown out the urgent calls for thorough, far-reaching studies.

Where We Falter: Gaps, Blind Spots, and Unfinished Business

• Earlier Intervention: Will devices show greater benefits if used earlier in the disease course, rather than waiting until patients are severely compromised?
• Synergy With Other Therapies: The dynamic between transcatheter tricuspid interventions and concurrent therapies for heart failure or left-sided conditions remains underexplored. Could integrated, multidisciplinary trials shed new light?
• Expansive Registries: Comprehensive, real-world data pools are crucial. They can illuminate long-term outcomes and patient-reported satisfaction, sharpening clinical guidelines and shaping future reimbursement landscapes.

The paths less traveled in tricuspid therapy are akin to dark comedies; everyone tunes in, curious, yet hesitant to be the first to chuckle out loud.

Curtain Call: Walking the Tightrope Between Promise and Pitfall

As we bring down the house lights on the tricuspid saga, it's clear this isn't just a tale of medical promise, it's a full-blown drama with potential plot twists. Tricuspid therapy has stepped confidently out of the shadows, parading as a beacon of hope for those once relegated to the wings due to frailty. Yet, let’s not mistake the opening act’s dazzle for a grand finale. The rush of initial data, while intoxicating, can be as deceptive as a magician's sleight of hand. As aficionados of true medical innovation, our applause should be reserved, our skepticism sharp. We must demand rigor over razzle-dazzle, ensuring our pursuit of the next big thing in cardiology isn’t just chasing after the wind. After all, in the high stakes game of heart health, it's critical to know whether we're witnessing a genuine revolution or just another enticing encore that promises more than it performs.

At RQM+, we’re committed to navigating these turbulent waters, advocating for a balance between groundbreaking advancements and evidence based medicine. If we aim to truly revolutionize tricuspid therapy, our resolve to remain accountable at every juncture will be our guiding star. Get in touch with our team of experts today to learn more about how we can support your devices.

Innovation ignites change; steadfast evidence fans the flames. True transformation demands both. 

More from this author:

• Technical brief: MitraClip and the Business of American Healthcare: Innovation, Inefficiency, and the Cost of Care
• White paper: Shattering Barriers: Advancing Healthcare Equity by Enhancing Diversity in Clinical Trials for a Future of Inclusive Innovation
• Technical brief: Bridging Treatment Gaps in Heart Failure with Reduced Ejection Fraction: Advancing Evidence for Device-Based Therapies
• Technical brief: Beyond Inclusion: Reimagining Equity and Real-World Impact in Heart Failure Trials
• On-demand panel discussion: Medical Device Cybersecurity: Proven Strategies for Connected Devices and SaMD