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Technology developments for tomorrow

ESC Congress News 2016 - Rome, Italy

In a Symposium this morning three experts look ahead to see what the future holds for artificial hearts, TAVI and mobile health technologies. Whatever they see, progress will certainly be swift.



Volkmar Falk, from the Charité University, Berlin, on artificial hearts

Currently, two types of total artificial hearts are available. The SynCardia device, approved by the FDA in 2004 as a bridge to transplant, has been used in over 1400 patients. The longest survived 1374 days before successfully receiving a donor heart. SynCardia has an external pneumatic pump carried in a back pack, and pneumatic tubes passing through the skin delivering pulses of air to two pumping chambers that force the blood into the circulation.

The second device is the Carmat bioprosthetic heart, implanted into the first patient by French surgeon Alain Carpentier in December 2013. Since then it has been used in three other patients. Carmat consists of right and left ventricular cavities, containing two miniaturised motorised pumps that displace the biomembrane and reproduce ventricular wall movement. Notably, surfaces coming into contact with blood are made from bovine tissue, and the device has sensors detecting blood pressure and volume changes to speed up or slow down the pump. The first patient lived for 74 days, the second for nine months, while the third died from renal failure. Carmat are planning the PIVOTAL study in 20 patients with low likelihood of receiving donor hearts.

A great deal of research is ongoing to improve artificial heart design and miniaturise pumps to make percutaneous implant techniques possible. Areas of endeavour focus on improving biocompatibility (by enabling endothelialisation of surfaces in contact with blood), energy transfer (to avoid transcutaneous wires and reduce infections), and feed-back algorithms (to allow pumps to respond to exercise).

Alain Cribier, from the University of Rouen, on transcatheter aortic valve implantation

TAVI is today  indicated for patients who are not good candidates for surgery. But for the future I predict the tables will turn and surgery will only be for patients who are not good candidates for TAVI.

TAVI is already well established for high risk patients, with the five-year analysis from the PARTNER trial showing ‘mortality equivalence’ between TAVI and surgery. Earlier this year, the PARTNER II trial, presented at the ACC meeting showed equivalence between surgery and the SAPIEN XT valve for intermediate risk patients, with significantly improved mortality for those treated via the transfemoral approach. The superiority of TAVI was even more significant with the last generation of Edwards valve, the SAPIEN 3 (PARTNER IIS3 trial).

In view of these results, we definitely need to rewrite the guidelines for TAVI. The PARTNER III trial, now ongoing, aims to compare TAVI and surgery in all comers older than 65 years. If the results are again equivalent, then surgery might soon be reserved for younger patients (the >5 year durability of TAVI valves remains unknown) or to those with severely calcified or bicuspid valves. 

The four-fold predicted expansion of TAVI within the next decade will also be driven by remarkable technological advances, making the procedure simpler, safer and more cost-effective. With the newer devices, it is now possible in nearly 90% of patients to implant the valve like a stent, using a minimalist transfemoral route, under local anaesthesia and with very early discharge (within one to three days), which for patients represents a major advantage for TAVI over open heart surgery.

Partho Sengupata, from Mount Sinai, New York, on ‘mobile’ health

In my view there are five classifications of mobile health technologies - smartphone health apps, smart phone connected devices, wearable and wireless devices, hand-held imaging platforms and miniaturised sensor-based technologies.

With over 160,000 smartphone health apps now available there’s no doubt that digital medicine is here to stay. According to a law developed by Gordon Moore, one of the inventors of integrated circuits, there’s exponential growth in technological progress, with the result we are likely to witness of the order of 20,000 years of 21st century progress in comparison to the hundred years achieved in the 20th century.

With all this data there’s a danger clinicians will feel completely swamped and suffer from information overload. Such future scenarios point to the need to develop ‘decision support systems’ (much like those used today by airline pilots) helping doctors navigate the complex information.  

We recently completed follow-up of a study where patients with structural heart diseases were randomised to smart clinics (using smart apps to monitor oxygen saturation, heart rate, blood pressure and pocket ultrasound) or usual clinical assessment. Results showed that those randomised to mHealth had more timely recognition and referral for corrective surgery and interventions with fewer hospital admissions and lower mortality. The implementation of apps and decision supports using machine learning would also lead to a more precise and quicker estimations of the problem and allow us to free up time to take better individualized care of our patients.

Don’t miss: Looking at the crystal ball – Be prepared for the revolution!  08:30-10:00   Michelangelo - The Hub

 

Click here to read other scientific highlights in the full edition of the Congress news.