Take Home Message
- This paper, reinforcing the LACES statement, stirs controversy over the 2020 ACC/AHA recommendations for intervention on the aortic valve, SAVR or TAVI, thoroughly examined and discussed.
- Este documento, que refuerza la declaración de LACES, suscita controversia sobre las recomendaciones de ACC / AHA 2020 para la intervención en la válvula aórtica, SAVR o TAVI, las cuales son examinadas y discutidas a fondo
- Este artigo, reforçando a declaração do LACES, suscita a polêmica sobre as recomendações do ACC / AHA de 2020 para intervenção na valva aórtica, SAVR ou TAVI, exaustivamente examinadas e discutidas.
This abstract is available on the publisher's site.
From the paper in question, became clear an overestimation of benefit and the downplay of harm in the appreciation of SAVR vs TAVI.
The consequences are manifold. First, the recommendations impact the lives of our patients, our life, and the healthcare budget of our nations, where expenditure to cover unnecessary and even harmful procedures will deplete the funds necessary to treat all people in need. More people will die consequently.
But, more worrisome, the article unveils a far-reaching consequence, the existential threat to the practice of the medical profession. The foundation of the medical profession lies in the patient’s trust in doctors, the best and truthful evidence used solely for benefiting people and patients. Once this paradigm is lost, the medical profession risks its downfall.
Necessarily, a new relationship has to be erected in establishing evidence for medical practice, as this model became indecorous and unacceptable. The collaborative work with industry to be maintained, aiming a balance between the monetization for a fair financial return but forsaking the interference in constructing evidence, a trusted and independent endeavor shall prevail.
Below are some proposals for change and a call for further discussion and refinement:
- Influential and vital medical research – RCT - designs and planning should be thoroughly discussed with related medical societies and the final protocol mutually agreed upon before launch.
- The PI should be an acknowledged and honorable physician, with no COI or reason to skew the outcomes.
- Should be strictly aimed to provide key and objective information to support people and patient’s benefits.
- The RCT data should be made entirely open for thorough and unbiased analysis.
- RCT not conforming with this clear regulation should not be included in guidelines.
- A board should be set up to supervise the correctness. Periodical reevaluation is mandatory, the interim results to be discussed in international meetings and forums.
- Reputed and accredited medical societies worldwide will be in charge of the research rightness, intended solely to benefit patients.