Avoiding the ‘crack’
A minimally-invasive surgery to replace a failing heart valve is on its way to approval by the US FDA for low-risk patients, in place of open heart surgery.
WHETHER he’s snatching a heavily-loaded weight bar off the ground or pushing it overhead in the classic clean-and-jerk stance, Robert Strange is a living example of the revolution underway in heart valve replacement surgery.
Last May, the 82-year-old California resident entered a clinical trial for a minimally-invasive procedure to replace a balky aortic valve that restricted his circulation and left him feeling light-headed, especially during exercise.
Seven days later, he was back in his garage adding a fresh set of scuffs to the well-abused pile of plates that have been his obsession since he first started Olympic lifting at the age of 58.
But those weights would probably still be on the ground if Strange had opted for an “open” aortic valve replacement procedure, which requires surgeons to sever the breastbone with a scalpel to gain access to the chest cavity for open-heart surgery.
Avoiding what some in the medical community call a “crack” was imperative for a man whose father did not survive a similar operation.
“They opened him up, and a week later, they had to unplug him. He never regained consciousness,” Strange said. “I said, ‘no, I don’t want that.’”
Though transcatheter aortic valve replacement (TAVR) has been available to high-risk patients – those deemed too frail to survive open-heart surgery – since 2012, thousands of low-risk patients like Strange – people who are otherwise in good health – have had to enter a clinical trial to get Medicare to pay for the procedure.
But that’s likely to change soon due to a new set of results recently presented at the American College of Cardiology’s annual meeting in New Orleans.
Results showed that TAVR delivered a significant reduction in strokes, a somewhat lower chance of death and significantly shorter recovery times for the 725 randomly-assigned patients whose results were compared to a like number of patients who underwent traditional open valve replacement surgeries.
“The results with the minimallyinvasive catheter procedure are so good, they’re actually better than the open procedure, which was a bit of a surprise to us,” said Dr Paul Teirstein, chief of cardiology and director of interventional cardiology at Scripps Prebys Cardiovascular Institute where Strange was treated.
The physician predicted that, seven years after the US Food and Drug Administration (FDA) approved TAVR for high-risk patients, a similar move is in the cards for low-risk patients.
That, he said, should further shift the odds for patients in need of valve replacement.
“In 2017, about 70,000 patients in the United States got their heart valves replaced,” Dr Teirstein said.
“Two-thirds of them were done with TAVR and about one-third with open surgery.
“With the results we’ve seen in the recent studies, you’ll see a real minority of them done open in the future.”
Catheter alternative
Interventional cardiologists use a long thin wire called a catheter, rather than a scalpel, to access the spot where the left ventricle – the heart’s main pumping chamber – connects to the body’s biggest blood vessel, the aorta.
They start with a puncture in the femoral artery in a patient’s groin, and using X-ray technology to see the path ahead, push the catheter to the heart, pushing right through the flaps of the patient’s aortic valve, which is usually failing due to a buildup of calcium deposits that prevent it from opening as far or sealing as tightly as it should.
With the catheter temporarily anchored inside the heart, they push in a cleverly-constructed circle of wire mesh similar to the stents routinely used these days to push open blocked blood vessels.
When the tiny package is inside the failing valve, it’s expanded, unfurling three new man-made valve flaps that push the original equipment out of the way and immediately begin opening and closing with each heartbeat.
Though several stitches are required to close the puncture in a patient’s femoral artery, they usually only need an overnight stay in the hospital, rather than the six days that are required after getting cracked.
With no incision in his chest, Strange was free to get back to his lifting routine just a week after getting his new TAVR valve installed.
Before sliding a few plates onto his Olympic-sized weight bar, the father and grandfather said he made sure to test the new “equipment” out with a walk up the steep road to his hilltop Solana Beach community.
He was surprised, he said, to feel much less out-of-breath than he did before heading to the hospital.
“It just felt ... normal. That was surprising for sure. It didn’t really feel like anything,” he said.
Don’t wait
A former farm boy from Oregon with hands thickened by years of hard work followed by a career hefting cases full of law books – he worked for a legal publisher selling bound volumes to lawyers – Strange looks right at home sweating as he grips the knurled bar, testing its heft before levering it to his hips, then quickly jerking it upward, putting far more than 100 pounds (45kg) into the air.
Last November, he was ready to travel to Salt Lake City where he notched a fresh set of records in the men’s 80-84 age group of the US National Masters weightlifting competition.
He’s headed back to Utah this week to see if he can best 308lb (139.7kg), the total weight mark he set last year by hefting 176lb (79.8kg) in the clean and jerk, and 132lb (59.9kg) in the snatch.
It’s quite an achievement for a man who didn’t start power lifting until the age of 49 and who didn’t start Olympic manoeuvres until age 58.
He said he saw that TAVR is already widely available in Europe and was determined to wait for his opportunity to have a minimallyinvasive procedure, even if that wait was significant.
“I said, ‘I’ll wait two years, I don’t care’, and they said ‘well, if you wait two years, you’ll be dead’, so I’m glad they let me in the trial,” Strange said.
“I mean, my arteries were fine, I’ve tried to take care of myself, so I didn’t want to be opened up and have to take all that time to recover.”
The TAVR trial is quite large with centres at hospitals across the US, so many patients have been able to go the minimally-invasive route if they insisted on doing so, Dr Teirstein said.
Some though, have not met stringent trial requirements and have been left waiting for FDA approval, which is expected to quickly become a procedure that Medicare covers, once its use in low-risk patients is formally accepted.
In the meantime, Dr Teirstein said, no one should be waiting for approval on their own.
Supervision by a qualified cardiologist is crucial and there are certain signs of severe valve damage that should not be ignored.
“If a patient, for example, is having fainting spells, that’s one of the signs that aortic stenosis has really gotten bad,” he said.
“If they’re having chest pain from that stenosis, if they’re being hospitalised because they can’t breathe, they’re short of breath, those are signs the valve needs to be replaced sooner rather than later.”
Not all eligible
The procedure is not a panacea. If a patient has a bicuspid aortic valve with two leaflets rather than three, or an especially large buildup of calcium on and around the portal, then the replacement device may not be able to form a tight seal against blood vessel walls as it expands in place.
Blood vessels that are blocked or that take a particularly tortuous path through the body can also require an open procedure.
Cost has not been a limiting factor for TAVR acceptance.
Though the cost of a TAVR valve is much more expensive than one that a surgeon would suture in place during an open procedure, total costs once longer recuperation times and higher hospital readmission rates are factored in, make the minimally-invasive method between US$8,000 (RM32,821) and US$10,000 (RM41,026) cheaper, according to a 2018 comparative cost study published in the medical Journal Circulation.