MedicalResearch.com Interview with:
Giovanni Esposito MD, PhD
Associate Professor of Cardiology
Department of Advanced Biomedical Sciences
Federico II University, Naples
Napoli – Italy and
Giuseppe Gargiulo, MD
Federico II University of Naples, Italy
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Esposito: Aortic stenosis (AS) is the most frequent type of valvular heart disease in Europe and North America. As soon as symptoms occur, the prognosis of severe AS is poor, with majority of patients dying within 2 to 5 years. Unfortunately medical therapy of AS has no significant effects on patient survival, therefore the only treatment able to improve patient prognosis is valve replacement. Until 2002, the only treatment strategy was the surgical aortic valve replacement (SAVR). SAVR requires an open-heart procedure and cannot be offered to all patients with AS due to their advanced age and presence of comorbidities that make them inoperable or at high-risk for surgery.
In the last decade, the less invasive percutaneous approach called transcatheter aortic valve implantation (TAVI) has demonstrated to be a valid alternative to SAVR for those patients deemed inoperable or at high risk for SAVR. After the first percutaneous intervention performed by Alain Cribier in 2002, TAVI has rapidly accumulated growing interest and enthusiasm that led to the first PARTNER trial guiding current guideline recommendations. Both American and European guidelines recommend to perform TAVI in all patients judged inoperable, and to consider TAVI as an alternative in high-risk patients, but with a Class IIb and a preference to SAVR. However, scientific evidence on TAVI exploded in the last few years, the guidelines cited are outdated (2014 and 2012 respectively), we have today 5 randomized trials and many other observational studies including patients with different pre-procedural risk (i.e lo-to-intermediate and high-risk), as well as long-term results of prior studies (i.e. 5-year follow-up of the PARTNER trial and 3-year of the US CoreValve trial), therefore we conducted a systematic review and meta-analysis comparing clinical outcomes, including short- and mid-term mortality, of adult patients with severe aortic stenosis undergoing either TAVI or SAVR with the aim to update this comparison and offer new perspectives.
MedicalResearch.com: What should readers take away from your report?
Dr. Esposito: The take-home message of our analysis is that TAVI and Surgery are associated with similar mortality in the overall population (including low to high risk patients) and that the use of transfemoral TAVI was even more beneficial than Surgery. Importantly, we also observed similar mortality in the subgroup of patients at low-to-intermediate risk. This study supports the upgrade and extension of current guideline recommendations, but we believe that the daily decision-making should remain an individualized strategy patient-by-patient shared by the Heart-team.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Dr. Esposito: Our study will also be the basis for future research. In particular, future research is expected to mainly focus on:
• Long-term outcomes and durability of the percutaneous devices.
• Patients with a lower pre-procedural risk (currently 2 large randomized trials have been designed and are going to be conducted in low risk patients).
• Assessing the impact and the potential benefits of new technologies and specific. procedural aspects such as transfemoral TAVI, which was found in our study to significantly reduce mortality compared with SAVR.
• Future studies on the overall cost-effectiveness of these procedures might provide further interesting insights on this topic.
MedicalResearch.com: Is there anything else you would like to add?
Dr. Esposito: The primary objective of our study was to compare TAVI and SAVR in terms of mortality at 30-day and 1-year due to its clinical relevance and the large availability of studies providing this information. However, we also explored other outcomes and found that at 30-day TAVI reduces myocardial infarction compared with SAVR, as well as acute kidney injury, major bleeding, and new-onset atrial fibrillation, but its benefits on early cardiovascular death and stroke remain to be clarified. On the other hand, pacemaker implantation, vascular complications, and paravalvular leak occur more often after TAVI than after SAVR and future research should also aim at reducing these complications after TAVI.
MedicalResearch.com: Thank you for your contribution to the MedicalResearch.com community.
Gargiulo G, Sannino A, Capodanno D, Barbanti M, Buccheri S, Perrino C, et al. Transcatheter Aortic Valve Implantation Versus Surgical Aortic Valve Replacement: A Systematic Review and Meta-analysis. Ann Intern Med. [Epub ahead of print 7 June 2016] doi:10.7326/M16-0060
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