SPC365

Freedom Solo Stentless Bioprosthesis for Aortic Valve Replacement - clinical and hemodynamic evaluation through systematic review and meta-analysis

Session: Posters (Sessão 1 - Écran 5) - Cirurgia Cardíaca
Speaker: José Rui de Oliveiros Vicetro Abrantes Saraiva

Congress: CPC 2023
Topic: H. Interventional Cardiology and Cardiovascular Surgery
Theme: 26. Cardiovascular Surgery
Subtheme: 26.11 Cardiovascular Surgery - Other
Session Type: Pósters Electrónicos
FP Number: ---
Authors: José Vicetro Saraiva; Francisca Almeida Saraiva; Rui João Cerqueira; Silvia O. Diaz; António S. Barros; André P. Lourenço; Adelino Leite-Moreira

<p style="text-align:justify"><span style="font-size:11pt"><span style="font-family:Arial,sans-serif"><span style="color:#000000"><span style="font-size:10pt">Background: The freedom Solo valve </span><span style="font-size:10.5pt"><span style="color:#4d5156"><span style="background-color:white">was introduced</span></span></span><span style="font-size:10.5pt"><span style="color:#4d5156"><span style="background-color:white"> in 2004 as a modified version of the Pericarbon Freedom stentless valve. In theory, its characteristics meet most of the required for the perfect valve. It is utmost important to collect and systemize evidence of survival and complications, to support its safety and satisfactory outcomes.</span></span></span></span></span></span></p>

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<p style="text-align:justify"><span style="font-size:11pt"><span style="font-family:Arial,sans-serif"><span style="color:#000000"><span style="font-size:10pt">Objectives: To describe, through a systematic review, early and long-term outcomes after aortic valve repair (AVR) with the Freedom Solo Stentless Bioprosthesis.</span></span></span></span></p>

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<p style="text-align:justify"><span style="font-size:11pt"><span style="font-family:Arial,sans-serif"><span style="color:#000000"><span style="font-size:10pt">Methods: A literature review was performed using 3 databases (Pubmed, Web of Science and Cochrane library). Studies with sample size above 30 patients and that reported at least one of the following outcomes: mortality, immediate complications, need for reoperation or hemodynamic evaluation were included. Articles addressing specific subgroups were excluded (e.g. infective endocarditis). Baseline, operative and post-operative data were collected from each included paper for Freedom Solo patients. &nbsp;Random effects models were used to compute pooled estimates by generalized linear mixed-effects model and logit-transformed for proportions and by inverse variance method for continuous variables. </span></span></span></span></p>

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<p style="text-align:justify"><span style="font-size:11pt"><span style="font-family:Arial,sans-serif"><span style="color:#000000"><span style="font-size:10pt">Results: From 357 records screened, 60 studies were selected for eligibility assessment. Out of these, 31 studies were included in this meta-analysis. Studies&rsquo; sample size ranged between 30 and 625, totalizing 6926 patients, pooled proportion for men: 49%, CI95%: 45-53. The pooled mean age was 74 years (95%CI: 74-75). The main indication for the procedure was aortic stenosis, accounting for 75% (95%CI: 68-77) of patients. The pooled proportion of concomitant procedures was 27% (95%CI: 12-50) and the pooled mean Logistic Euroscore (available in 13 studies) was 9.5%, 95%CI: 8.5-10.4. Regarding early outcomes, hospital mortality occurred in 2% (95%CI: 2-3) of patients (reported in 25 studies), bleeding problems in 4% (95%CI: 2-6, 16 studies) and neurological events in 2% (95%CI: 2-3, 16 studies). Pacemaker implantation was needed in 2.2% (15 studies). </span></span></span></span></p>

<p style="text-align:justify"><span style="font-size:11pt"><span style="font-family:Arial,sans-serif"><span style="color:#000000"><span style="font-size:10pt">The follow-up time ranged from 5 days to 9 years. The hemodynamic data at the maximum follow-up time showed mean pressure gradient and effective orifice area of 10mmHg (95%CI: 8-12) and 1.56cm<sup>2</sup> (95%CI: 1.17-1.95), respectively. Survival rates at 1-, 3- and 5-years ranged between 88% and 99% (reported in 16 studies), 83% and 96% (9 studies) and 59% and 94% (11 studies), respectively.</span></span></span></span></p>

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<p style="text-align:justify"><span style="font-size:11pt"><span style="font-family:Arial,sans-serif"><span style="color:#000000"><span style="font-size:10pt">Conclusion: Aortic valve replacement with the Freedom Solo bioprosthesis can be considered a safe procedure, as supported by the satisfactory early and mid-term outcomes.</span></span></span></span></p>