ARISE clinical study presented at the 31st Annual Meeting of the European Association For Cardio-Thoracic Surgery (EACTS) 2017 in Vienna

Brazilian group reports results of decellularised allografts used for RVOT construction during the ROSS operation

Training workshop for young surgeons held in Barcelona in November 2017

Prof. Dr. Samir Sarikouch presented the current status of the ARISE clinical study during a Focus Session on “Alternative surgical approaches for aortic valve replacement” at the 31st EACTS Meeting in Vienna, Austria on Tuesday 10th of October 2017. He gave an overview about the current inclusion to the clinical trial. So far, 99 patients have been operated within the trial. 14 more operations are already scheduled, which means that the calculated minimal sample size of 120 study participants can be safely achieved in 2018 well ahead of the study schedule.

During the same congress Prof. Francisco da Costa presented the results of “Fresh decellularized versus standard cryopreserved pulmonary allografts for RVOT reconstruction during the Ross operation” operated by his group from Curitiba, Brasil (Abstract No. 0349). He presented data of 190 decellularized allografts used for pulmonary valve replacement with a mean follow-up time of 3.7 ± 2.5 years. Freedom from late peak gradients ≥ 40 mmHg was significantly better for the dCell group (95.8%, CI 95%  = 87.9 – 98.6%)  than in the standard cryopreserved group  (88.5%, CI95%  = 82.6- 92.5%) at  10 years (p=0.04). He concluded that “although longer follow-up is still necessary, this study demonstrated that decellularized allografts have superior hemodynamic performance at 10 years when compared to conventional cryopreserved allografts”.

On Friday the 18th of November 28, 2017 the ARISE partners conducted a training workshop for young surgeons focusing on the techniques for the implantation of decellularized homografts for aortic valve replacement. Under the patronage of the former EACTS president Prof. Jose Luis Pomar the workshop was held at the Hospital Clinic Barcelona, Spain.

Programme:

08:30

Welcome and Introduction.

Dr. Axel Haverich and Dr. José L. Pomar

08:45

What is the H2020 program of the European Union?

Juan Abolafia

09:05

Why ARISE and ESPOIR got funding from the European Framework Programme.

Dr. Axel Haverich

09:30

Summarizing the goals and rationale of the ARISE Project.

Dr. Samir Sarikouch

09:45

The role of the European tissue banks.

Dr. Ramadan Jashari

10:15

Let us explain to you how this technique works:

a) The first human implantation of a decellularized homograft in the ARISE project – Live-In-A-Box case

Dr. Igor Tudorache

b) The first implantation in our hospital - Live-In-A-Box case

Dr. Eduard Quintana

10:45

How the Spanish and Catalan Transplantation Network could help to disseminate the project’s results.

Dr. Esteve Trias

11:00

Reimbursement of cell-free homografts beyond ARISE.

Dr. Michael Harder

11:15 Coffee break

11:45

Current outcomes of the ARISE project.

Dr. Samir Sarikouch

11:55

Current outcomes of the ESPOIR project.

Dr. Dietmar Böthig

12:05

Results from other researchers.

Dr. Samir Sarikouch

12:15

Reasons for concern? The Mayo Clinic report.

Dr. Axel Haverich

12:30

Let's go to practice! - Wetlab: Tips and tricks for the implantation of decellularized homografts. Animal hearts and Live-In-A-Box cases.

Dr. Daniel Pereda and Dr. Eduard Quintana

14:00 Lunch

15:00

Wetlab continuation.

17:30

Conclusions for the media.