Heart devices don't work like pills, so why do we try to fund them that way?

Cardiology is changing fast. Roughly every one to two years, clinicians get access to a new generation of heart technology: transcatheter edge-to-edge repair (TEER) — tiny clips that repair leaking heart valves without open surgery; Impella heart pumps — miniature pumps, threaded in through a blood vessel, that keep a failing heart beating during high-risk procedures or when it suddenly can't pump enough blood on its own; specialised wires and tiny tubes that clear arteries once thought too blocked to treat; transcatheter aortic valves (TAVR) — replacement valves delivered through a small tube instead of a scalpel; leadless pacemakers, roughly the size of a vitamin capsule; and AI-enabled heart monitors patients wear home.

The problem is how New Zealand decides which of these get funded. Right now, cardiac devices go through the same assessment process as pharmaceuticals — a process built for pills, not for devices. That mismatch delays access for patients and inflates costs downstream.

A pill doesn't change. The medicine approved this year is chemically identical to the one on the shelf in ten years. A heart device is the opposite — an Impella pump, a cardiac catheter or a heart valve can go through two or three design upgrades within a single funding review cycle. By the time officials finish assessing a device, the version they examined has often already been superseded.

There's also a human factor a pill doesn't have: the person (operator) using it. A statin works the same in any hand; a device does not. Success rates for opening chronic total occlusions (blocked coronary arteries) climb sharply with operator volume and training. That's why hospitals overseas already require TAVR and TEER teams to have performed a minimum number of proWcedures before they're allowed to offer them, and why an Impella pump only works as well as the wider emergency team supporting it. A funding process that ignores this will always misjudge what a device is really worth once it's in everyday use.

Trial timelines compound the problem: pivotal studies for cardiac devices often report their results after the next generation of the device is already approved overseas, leaving funders perpetually reimbursing yesterday's technology. A pill's value is measured in cost per dose. A device's value shows up elsewhere — the open-heart surgery it avoids, the shorter stay in intensive care, the readmission that never happens. Standard drug-funding logic isn't built to see any of that.

Consider the stakes. Cardiovascular disease remains the leading cause of death globally and one of the largest single drivers of hospital, surgical and long-term care spending. Now consider the evidence we already have. Device registries - shared databases that track how patients do after getting one of these devices - like TVT (Transcatheter Valve Therapy Registry), IMPELLA Quality, and PCI (Percutaneous Coronary Intervention) link to risk scores and generates real-world outcome data that could support earlier, evidence-based reimbursement decisions.

There is also the speed at which the procedures themselves keep shifting: TEER – a less invasive procedure that often replaces open-heart surgery in patients who are too high risk for major operations and who are not benefitting from medical approaches; TAVR replaces surgical valve replacement, and a successful catheter-based opening of a blocked artery can avert bypass surgery altogether — dramatically compressing hospital stays, intensive-care use and recovery times. Our current New Zealand regulatory processes aren’t keep up with this technological advancement – and that’s where the issue lies.

The evidence for early access is consistent from country to country: getting new cardiac devices to patients sooner lowers the overall cost of care, even when the device itself is expensive. In the landmark COAPT trial, TEER — the valve-repair clip — cut heart-failure hospital admissions roughly in half for patients with a leaking mitral valve. Impella-supported procedures give selected high-risk patients an alternative to open-heart surgery to restore blood flow. And successfully opening a chronically blocked artery means fewer hospital visits for chest pain and fewer repeat procedures.

Even where a device carries a higher upfront price, the system-level savings — fewer open-heart operations, shorter stays in intensive care, lower 30-day readmissions, less downstream heart-failure care — frequently appear within two to three years. Delaying access does not save money. It shifts cost into emergency care, disability and lost productivity.

Because so much of a device's value depends on who is using it, the heart specialists who actually implant TAVR valves, deliver TEER and run emergency heart-pump teams need to be full members of the committees that approve and fund these devices — not experts who are simply consulted along the way. They're the ones who know which patients actually benefit, and how much experience a hospital needs before a device works as well in practice as it did in the trial.

In practice, that means clinicians helping set the rules for which hospitals qualify to offer a device, tied to how many procedures they've done — the same approach already used for TAVR and TEER overseas. And it means clinicians and funders jointly building the registries that track how a device performs in ordinary hospitals, on ordinary patients, not just in the original clinical trial.

Cardiology is the fastest-moving frontier in medical device innovation – which is why the Cardiac and Respiratory Foundation NZ is calling for a pilot approval and funding pathway for cardiac devices. This has to be separate from the pharmaceutical process, and built on five ideas:

• Conditional, time-limited approval, tied to mandatory real-world evidence collection through device registries.
• Fast-tracked review of upgrades — minor hardware or software improvements to an already-approved device shouldn't need a full resubmission from scratch.
• Assess cost and clinical benefit together, in a single accelerated process, not sequential reviews stacked years apart.
• Ring-fenced innovation funding, so a device isn't blocked by a hospital's tight annual budget cycle when the long-term system savings are clear.
• Formal seats for practising heart specialists — including those who perform these procedures and those who manage heart rhythm problems — at every stage: approval, funding, and reviewing how a device performs after launch.