Heart transplantation: aetiology and history
Heart transplantation is the surgical replacement of a diseased, failing heart with a compatible and healthier heart from a donor. Patients with advanced heart failure undergo heart transplantation only when other treatment options have not succeeded. Heart failure can occur due to several conditions, including cardiomyopathy, coronary artery disease, heart valve disease, congenital heart disease, ventricular arrhythmias, etc.
Dr Christiaan Nethling Barnard, a South African doctor in Cape Town, conducted the first clinical interhuman heart transplant in 1967. The survival time for the first heart transplanted patients ranged from a few hours to a few months. Currently, heart transplantation is a widely accepted treatment for advanced heart failure, with a 1-year survival of 91% and a median survival of 12 to 13 years. The average number of heart transplantations since the 90s has plateaued at about 3500 transplantations per year. This number is not expected to increase, mostly due to the limitation in donor supply.
Heart transplant in Spain: legislation and numbers
Spain has been the worldwide leader in donations and transplants for 28 consecutive years. In 2019, Spain provided 20% of donors in Europe and 6% of donors worldwide, with a rate of 49.6 donors per population million. There were 2301 donors and 5449 successful transplants. Of these, 300 were heart transplantations.
The high numbers above are mostly explained by the “opt-out” system contemplated in the national organ extraction and transplantation law dating from 1979. This law considers that all deceased people as donors (even if they have never registered officially) unless there is an express opposition from the deceased or the direct family. Last year, 86% of potential donor families agreed to the donation. Economically, donations in Spain are always altruist and are 100% covered by the national health system. Moreover, the national transplant organization (ONT) coordinates the transplants nationally, communicating with all the hospitals that can perform extractions and transplant surgeries, and keeping a national database.
Heart transplant unmet medical needs and clinical trials
Despite the advancements of heart transplantation technology and the improvement in survival rates, clinical trials are still needed to assess new heart preservation technologies and surgical techniques. As of 8th of December 2020, ClinicalTrials.gov, the largest clinical trial database, lists 358 studies with the clinical condition “heart transplantation” of which 64 are currently recruiting. Surprisingly, despite being an organ transplant world leader, Spain is only involved in 16 out of the 358 heart transplantation studies (less than 5%), and 5 out of the 64 currently recruiting (7.8%). This finding suggests that there is an unlocked potential for successful and quickly recruiting heart transplant (and organ transplant in general) clinical trials in Spain.
The team at AKRN are experts in ISO 14155 and good clinical practices (GCP), we have an excellent knowledge of competent authority and ethics committee submissions in Spain and a network of professional contacts in the country leader hospitals. AKRN can help you set up and execute your heart or organ transplant clinical trial in Spain, from site selection and site initiation and maintenance phase to close-out.
Subject Matter Experts
Maria Nyåkern, Ph.D. Founder & Executive Director LinkedIn
Ariadna Navarro, Ph.D. Associate Director Quality & Regulatory Affairs LinkedIn