Who gives the go-ahead for a novel heart procedure? At University Health Network in Toronto, a judging panel includes a frozen-food magnate, a real-estate developer and a 28-year-old entrepreneur who vet medical innovations alongside surgeons.
The stakes are high: A refusal to bankroll a new procedure from a $1.5-million fund can spell fewer interventional options for those with failing hearts.
"There will be some people where it will be a life and death decision," acknowledged cardiologist Harry Rakowski, chair of the innovation committee at the Peter Munk Cardiac Centre. "As physicians, we are used to struggling with those decisions."
But business executives aren't. Their bad calls may spell financial loss, but not a poorer quality or shortened life for patients. What they lack in medical knowledge, however, they make up in business acumen: They have a knack for backing a winner.
"You really want to approve everything because everything is so important," said panel member Jeff Rubenstein, chief executive officer of Export Packers Company Ltd., a fresh and frozen food company. "But on the other hand, you have a fiduciary responsibility. ... You really can't approve everything because there isn't an unlimited amount of funds."
Barry Rubin, medical director of the cardiac centre, had the idea to create an innovation judging committee that would include business people who "have a good sniff test."
Before this vetting process, doctors who wanted to test new procedures not funded by the public health system would ask administrators to find money from a hospital's global operating budget, a fixed pot of cash. Others have preferred the more time-consuming route of building relationships with philanthropists in hopes of attracting funding.
With constraints on public-health spending and provinces seeking fee reductions from doctors, innovation has become the key watchword. Canadian hospitals have little left in their budgets for innovative projects, which are often the first to go in tight fiscal times. This novel model is a potential solution because it provides not only a structure but a process; it helps ensure donor money is wisely spent, while trying to encourage innovation among health-care providers.
In this case, written proposals must answer 10 questions, plus commit to a study on cost-effectiveness for up to three years. That proposal then goes before the 13-member committee that includes five lay people, doctors, surgeons and a hospital administrator. After the panel rates the proposal with a letter grade and renders its decision, it goes to the cardiac centre's executive committee for final sign-off. After the cost-effectiveness study, it goes to a government-funded body that makes a recommendation to Ontario on whether the procedure should be funded.
At the first meeting to vet new proposals in late March, four ideas were on the table competing for a piece of the $1.5-million fund – a donor sum kick-started by Peter Munk and expected to climb to $2-million by next year.
One proposal was a treatment that controlled persistently high blood pressure. Another reduced the chances of amputation by inserting a balloon coated with drugs into leg vessels of patients with tissue-clogged stents. A third created a Web-based score that could help select which heart failure patients are at high risk of dying if not admitted to hospital.
A proposal that cost $30,000 per patient, however, was the one that caused the most discussion. It involved a clip to help reduce mitral regurgitation, a condition where the heart valve does not close properly when the heart pumps out blood. Dr. Rakowski described the device as looking like a "really good paper clip."
It was, however, a treatment for heart patients who had run out of interventional options. Vlad Dzavik, deputy head of the division of cardiology at University Health Network, passionately argued on behalf of a colleague whose proposal it was, that it be funded.
"These are patients whose quality of life is incredibly poor," said Dr. Dzavik. "They don't have options. ... this provides a potential option."
Dr. Rakowski, who chaired the meeting, graded it as a B, noting "if we commit to this now, we're basically out of money." He estimated it would cost almost $2-million over three years to perform the procedure on just two patients a month.
As doctors hashed it out – some over the telephone, others in the room – Jordan Dermer, managing partner for CD Capital, a Toronto-based real estate development firm, seemed unsettled by the discussion.
"For me, there was great discomfort to be in judgment of what patient is deserving of additional quality of life," he said afterward. "It's not something a businessman should be deciding."
And yet, that's the business of doctors every day.
Even Eric Horlick, director of the structural disease interventional program, who authored the proposal, described it as a "big ask."
Another of his procedures, a transcatheter aortic-valve implant [TAVI]done on at least 170 patients who couldn't tolerate open-heart surgery, has been bankrolled by the innovation fund for about three years. The Ontario Health Technology Advisory Committee has since recommended the province fund it for those patients ineligible for open-heart surgery. It is now under consideration by the Ontario Health Ministry.
That's how innovation starts: at the hospital, funded by philanthropy.
One of the beneficiaries of this innovation is Toronto's Paul Szasz, 83, who had the TAVI operation – which involves inserting a replacement valve made of bovine tissue, mounted on a stainless-steel stent, into the human heart – in February, after open-heart surgery was deemed too risky. He is back at work, running the plastics moulding factory he founded.
"I like pioneering," said Mr. Szasz. "I've always believed in innovation."
Committee judges rank proposals with an A, B or C. Factored in to their ratings are how leading edge the procedure is, the benefit to patients and added costs to the hospital.
The Pitch: To reduce the number of amputations of those with peripheral artery disease by inserting drug-coated balloons into patients whose stents placed in leg vessels are clogged with tissue. An estimated 800,000 Canadians have peripheral artery disease, resulting from plaque in the arterial system, a condition that leads to nearly 10,000 amputations a year.
The Device: A drug-coated balloon is inserted into the femoral artery with a catheter, which delivers the medication paclitaxel at the site of the arterial disease, helping break down the tissue and prevent re-narrowing of the artery.
The Cost: $27,000 was funded for balloon therapy. Cost per patient is about $1,600.
The Grade: All As.
RENAL ARTERY DENERVATION
The Pitch: Reduce the amount of medication required by thermally heating or ablating the renal artery nerve as a way to control a patient's persistently high blood pressure and help prevent stroke, heart failure or kidney failure. The targets for the treatment are those 2 per cent of patients whose hypertension is not controlled despite various medications.
The device: A catheter-based renal denervation system. A radio-frequency generator sends a high-frequency signal through a catheter placed in a renal artery and alters nerve traffic, which reduces the stimulus for high blood pressure, with a foot switch and power cable, provided on consignment.
The cost: $366,000 cost approved. Medtronic, the current supplier of renal denervation catheters, was asked to find other funding for the co-ordinator and the stimulator device that delivers the ablation. Cost per patient: about $7,600, including follow up on blood-pressure monitoring.
The Grade: All As and one B.
Approved: Doctors have already begun performing the procedures.
The Pitch: To clip, with a catheter-mounted device, the middle of two central parts of the mitral valve, which regulates the flow of blood between the filling and pumping chamber of the left side of the heart. This is for the less than 5 per cent of patients at University Health Network whose heart failure is such that the risks of death during an open-valve operation are too high. It improves quality of life and in some cases, possibly lengthens life.
The Device: The MitraClip, a less-invasive therapy delivered by catheter to reduce mitral regurgitation, a condition where the valve does not close properly when the heart pumps out blood.
The Cost: $600,000 in the first year, plus $720,000 each of the two years afterward. Cost per patient: about $30,000.
The Grade: Three As, Seven Bs, one C
Not Approved. The proposal was sent back for revision with an eye to performing it on fewer patients and therefore using fewer clips and reducing cost.
EMERGENCY HEART FAILURE MORTALITY RISK GRADE SCORE FOR HEART FAILURE
The Pitch: To create a Web-based scoring system that helps indicate which heart failure patients are at high risk of death if not admitted to hospital. In year two, it would be developed as a smartphone app. Patients admitted for heart failure are normally kept in hospital between three and 14 days. This device can help determine who needs to be kept in hospital and who can be fast tracked through a new outpatient treatment clinic.
The Device: A computer-based algorithm created by physicians at the Peter Munk Cardiac Centre that provides a score based on a patient's vital signs and condition. Health-care providers, usually in emergency rooms, enter information on a website that when analyzed by a computer model, produces a score. That, along with clinical judgment, helps determine if a patient should be admitted.
The Cost: $30,000. Cost per patient: trivial. [A new clinic for rapid out-patient care at an as-yet-undefined cost would require additional funds.]/p>
The Grade: All As.
Approved for Web development.
Innovators from many backgrounds
The 13-member Peter Munk Cardiac Centre Innovation Committee panel has five lay people with backgrounds in including health-care consulting, real-estate development and entrepreneurial business development. [One lay person did not attend the last meeting] In addition, there are physicians, surgeons, a research fellow, a hospital administrator and a nurse.
Jordan Dermer is managing partner for CD Capital, a Toronto-based real estate development firm.
Angela Feldman is executive vice-president of Camrost-Felcorp, a Greater Toronto Area real-estate firm.
Jeff Rubenstein is chief executive officer of Export Packers Company Limited, one of the largest privately owned food companies in Canada.
Joelle Faulkner, 28, is a Rhodes and Fulbright Scholar, who is an entrepreneur in medical devices and agriculture.