“Can I get a soda?” These were the first words a 58-year-old man wrote on a clipboard after waking from his historic operation to implant a revolutionary, Australian-invented titanium heart. It was the first time the BiVacor total artificial heart has been placed in a living human.
The operation, more than a decade in the planning, happened on July 9 at the Texas Heart Institute in Houston. The device’s inventor, 45-year-old Brisbane-born biomechanical engineer Daniel Timms, was present during the 4½-hour surgery in which the patient’s diseased heart was removed and replaced with the Australian device, a 650-gram titanium pump with a single moving part.
“It’s hard for me to get perspective on what we’ve achieved,” Timms told this masthead. “There are fleeting moments – in the middle of the night, sitting on a recliner beside the patient’s bed, trying to get some sleep – when you suddenly think, yeah, it’s working. But mostly you’re just trying to dissect what’s happening and improve things for this patient, and the ones in future.”
The surgery team behind the US operation: Dr William “Billy” Cohn, Dr Alexis Shafii, Dr O. H. “Bud” Frazier, and Dr Daniel Timms, the Australian founder and chief technology officer of BiVacor.Credit:
The transplant surgeon who performed the operation, Dr Alexis Shafii, said the surgery “went great”. “Compared to doing it [during animal trials], it was actually much easier: the human anatomy is what it’s designed for.”
The medical team was amazed by the speed with which the patient, suffering from end-stage heart failure, recovered. As Dr William Cohn, a transplant surgeon and chief medical officer of BiVacor, said: “When his breathing tube was removed, the first thing the patient said was, ‘I feel great.’” In the following few days “he lost [8.6 kilograms] of excess fluid; off the breathing machine, able to walk. And not just a shuffling walk. An aggressive walk.”
INVENTOR INSPIRED BY HIS FATHER
Daniel Timms began work on the BiVacor heart more than 20 years ago, after his father Gary, a plumber, developed a serious heart condition. The pair worked on the design together until Gary’s death from heart failure in 2006, after which his son carried on, devoting his life to the project. The chief executive of the Texas Heart Institute, Dr Joseph Rogers, paid tribute to the low-key inventor.
“After the success of the operation, I said to him, ‘Daniel, have you called your mother?’ And he said, ‘I won’t do that until I hear the patient talk to his wife.’ I think that says everything about the man.”
Rogers said it was “beyond gratifying” to see the patient’s improvement. “To see a human being go from being so terribly sick to being much, much, much more stable, and then sitting up in a chair, then getting up and making laps, walking around – within a week of having the thing put in – it was remarkable.”
The operation was the first case in a US five-patient early feasibility study. Up to 10 Australian patients will also receive the device at St Vincent’s, Sydney, and The Alfred hospital in Melbourne in a second clinical trial, funded by the Medical Research Future Fund (MRFF). Following the success in Texas, this trial may begin before the end of the year.
The BiVacor device appears in a field littered with more than half a century of failures. Left ventricular assist devices (LVADs) have been in use for many years, but a successful total artificial heart has eluded researchers since 1969, when the first artificial heart was implanted. The patient survived just 96 hours.
In the decades since, attempts have been dogged by problems of size (no previous design has been small enough to be used widely in women or children), infection, blood clots and mechanical failure.
The BiVacor is the only total artificial heart in history to use maglev (magnetic levitation) technology and a single suspended spinning disc to pump blood through the body. This design – in which the sole moving part has no contact with any other surface – improves durability, lowers the risk of blood clots, allows for a higher pumping capacity (up to 12 litres a minute), and intrinsically adjusts to changing blood flow demands in the body.
“It’s absolutely fantastic technology,” said Professor Chris Hayward, heart failure and transplant cardiologist at St Vincent’s Hospital in Sydney. “It’s very exciting to see it work in a patient, and it really is a game changer. If we can replicate these results, it has the potential to really challenge our paradigm of advanced heart failure therapy.”
The BiVacor device is being used in the US as a bridge-to-transplant device: supporting patients until a biological donor heart becomes available. In this case, a suitable donor heart was found eight days after the BiVacor implant.
GRIM STATISTICS
In Australia, an average of one person dies from heart failure every three hours. Despite the success of the Texas operation, Timms’ goal has always been to use his invention as a permanent replacement for the biological heart. In February, BiVacor was awarded $17.5 million as part of a $50 million grant by the MRFF to establish the Artificial Heart Frontiers Program, led by Melbourne’s Monash University, to encourage cardiac device innovation in this country.
“These are the sort of stories and achievements we are all proud of,” said Professor David Kaye from Monash, co-director of the program. “It shows us that we are at the forefront – or ahead of the forefront – of new heart disease therapies internationally. Sometimes we doubt that, but we shouldn’t shy away from it. The whole team’s now excited to help Daniel get to the next iteration of the device.”
It’s hoped certain components of the BiVacor heart will be made in Australia when it is commercialised. The potential economic and social benefits are clear. But for Timms there’s a profound personal benefit, too. “When I saw the patient writing on his clipboard, it took me back exactly to 2006, when my dad was in the ICU,” he said on Wednesday evening.
“And obviously he didn’t get better, so that was the last way he ever communicated with me. But it’s the other way now. It was the end for my dad, but for this patient, it’s the beginning.”
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