Unique innovation meeting brings all members of the percutaneous valve community together

For the first time, PCR London Valves (18–20 September, London, UK) held a PCR Innovators Day.

The day provided an opportunity for all members of the percutaneous valve community—clinicians, innovators, MedTech executives, investors, triallists, and regulators—to review emerging technologies and discuss how they can work together to develop innovative solutions for unmet needs in valvular disease.

EuroPCR Course Director William Wijns, who has overseen three successful PCR Innovators Days at EuroPCR, explains that a PCR Innovators Day is unique both in terms of its content and in terms of its audience. “PCR London Valves, like other PCR courses, obviously discusses innovative therapies. But at a PCR Innovators Day, we try to be upstream of these therapies—it is really about discussing therapies that are at the ‘early days’ stage; before the first-in-man studies are performed. Furthermore, we try to bring together all members of the innovation ecosystem, who typically do not meet frequently. Normally, regulators go to regulator meetings, clinicians go to clinician meetings, and investors to go to investor meetings. Here, at PCR Innovators Day, all the members of the community get together,” W. Wijns noted.

The PCR Innovators Day at PCR London Valves had three themes: innovation in percutaneous mitral valve repair, innovation in percutaneous mitral valve replacement, and innovation in percutaneous tricuspid valve intervention. Acknowledging that new mitral and tricuspid therapies were also discussed at the spring PCR Innovators Day (16 May, Paris, France), W. Wijns stated that the PCR board decided to focus again on these therapies for the PCR London Valves innovation meeting because “the field is moving very fast”. He adds: “We are only four months down the road from the mitral and tricuspid session that we had at the EuroPCR PCR Innovators Day, but a lot of new information was shared at this PCR Innovators Day because there has been some interesting progress. There are many actors in the field of mitral and tricuspid therapies; it is not going to be an overnight solution—it will take some time because of the complexity of the structures we are dealing with.

PCR ID London 2016: illustration

Percutaneous mitral valve therapies

A key issue that was raised both during the session on mitral valve repair and during the session on mitral valve replacement was whether repair or replacement would emerge as the dominant percutaneous mitral valve therapy. Speaking at PCR Innovators Day, PCR London Valves Course Co-Director Alec Vahanian commented that there were advantages and disadvantages with both approaches. He said that while repair was associated with more natural haemodynamics and was thought to be safe, it was more complex, might only work in selected patients, and there are questions about the durability of repair devices. Replacement, on the other hand, could be simpler, more versatile and could produce a predictable reduction in mitral regurgitation but paravalvular leak and other safety issues were a potential concern. However, citing the view of Francesco Maisano, A. Vahanian reported that percutaneous repair and replacement could potentially be used as complementary therapies. For example, stand-alone annuloplasty could be used as an early treatment for functional mitral regurgitation, combined use of MitraClip (Abbott Vascular) and annuloplasty could be used for degenerative mitral valve regurgitation and advanced functional mitral regurgitation, and mitral valve replacement could be used for both advanced degenerative mitral valve regurgitation and advanced functional mitral valve regurgitation. “Percutaneous intervention will allow a larger number of patients with mitral regurgitation to be treated by less invasive surgery or interventional cardiology,” A. Vahanian concluded.

 

Presented percutaneous therapies for the mitral valve:

Repair

  • Edge-to-edge repair with MitraClamp (HeartWorks)
  • Indirect annuloplasty with Amend (Valcare)
  • Enhanced coaptation with the MPM Neo-Leaflet Transcatheter system (Middle Peak Medical)

Replacement

  • Caisson transcatheter mitral valve implantation (TMVI) device (Caisson)
  • Cephea TMVI device (Cephea)
  • A novel technique to prevent left ventricular outflow tract during TMVI (LAMPOON)

 

Percutaneous tricuspid valve therapies

During the session on innovative tricuspid therapies, the recurring theme was that tricuspid regurgitation was an unmet clinical need. PCR London Valves Course Director Stephan Windecker noted that functional tricuspid regurgitation was common in patients with left-sided heart failure and/or myocardial disease and “has a significant impact on survival” and that isolated surgical tricuspid replacement/repair “remains an infrequent intervention” and “is associated with important morbidity/mortality”. He concluded: “The implementation of less invasive percutaneous approaches in this field is of major clinical interest and addresses yet another unmet need.”

Presented percutaneous therapies for the tricuspid valve:

  • Minimally invasive annuloplasty (MIA, Micro Intervention Devices)
  • Direct annuloplasty with Cardioband (Valtech)
  • Tricuspid transcatheter repair with Tricinch (4Tech)

 

Different perspectives

As well as hearing from clinicians and innovators, the packed room—often standing room only—at the PCR Innovators Day also heard from representatives from industry and other members of the interventional community. Larry Biegelsen, a senior analyst from Wells Fargo who specialises in medical supplies and devices, gave the keynote speech “The value of innovation: perspectives from the worldwide financial markets”. He said both companies and investors benefit from innovation, noting that Edwards Lifesciences, Boston Scientific, Medtronic, and St Jude Medical—who all have transcatheter aortic valve implantation (TAVI) devices—have all seen their stock performance rise during the last two years (particularly Edward Lifesciences). “If you bought 100 shares of Edwards Lifesciences the day before it announced the acquisition of Percutaneous Valve Technologies (12 December 2003) for US$2,999, your shares would be worth $45,840 today—a return of plus 1,430%,” L. Biegelsen stated.

Throughout the day, there were opportunities for the diverse audience to learn from each other during the several structured networking breaks. The PCR London Valves app enhanced these opportunities by allowing participants to directly message speakers or fellow participants. Furthermore, for participants who were unable to connect with someone they wanted to talk to on the day, it is still possible to send messages via the app.

 

Conclusion

Summing up the day, PCR London Valves Course Director Nicolo Piazza commented that the day had been a success with “at least 290 registered participants with probably more popping in and out of the room” and said that this was testament to the fact that “our community—whether it be clinicians, industry representatives, or venture capitalists—are still very interested in the transcatheter valve space”. He added that the day showed that innovation “continues to be dynamic”, noting: “If you miss out on one of these PCR Innovation Days, you will be behind in the transcatheter field space”.

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