# Desfechos Intra-Hospitalares no Registro Brasileiro de Implante de Bioprótese Aórtica por Cateter – 14 Anos em Análise

## TL;DR

This study analyzes in-hospital outcomes of aortic valve implantation in Brazil over 14 years, identifying factors linked to mortality and complications.

## Contribution

The study provides insights into gender-specific and bioprosthesis-related complications in TAVI procedures in Brazil.

## Key findings

- Mortality was strongly associated with major vascular complications and acute kidney injury.
- Non-fatal complications were more common with first-generation bioprostheses.
- Female gender was linked to complications with second-generation bioprostheses.

## Abstract

O implante valvar aórtico transcateter (TAVI) apresenta crescimento exponencial de suas indicações e foi incorporado ao Sistema Único de Saúde em 2022, sendo necessário avaliar seu uso no Brasil.

Conhecer os fatores associados a mortalidade e complicações não fatais intra-hospitalares, em ambos os gêneros, na população do Registro Brasileiro de Implante de Bioprótese Aórtica por Cateter e Novas Tecnologias (RIBAC-NT).

Análise do banco de dados RIBAC-NT de 2008 a 2022. Aplicados modelos logísticos e
machine learning
na avaliação estatística da associação das variáveis com os desfechos, empregando o
software R
e nível de significância de 5%.

Analisados 2.588 pacientes (mulheres, 51,2%; óbito intra-hospitalar, 8,2%). Mortalidade associou-se a complicações do procedimento, dentre elas destacam-se complicações vasculares (CV) maiores e insuficiência renal aguda (IRA) (p< 0,001). A CV maior ocorreu em 6%, com 34% de mortalidade; IRA ocorreu em 8,8%, com 13% de mortalidade, que aumentou até 8 vezes quando IRA coexistiu com outras complicações. Complicações não fatais ocorreram em 50,5% do total de pacientes, acometendo 63% daqueles com bioprótese de 1a geração (1G) e 39% daqueles com bioprótese de 2a geração (2G) p<0,001. O acesso não femoral e o ritmo cardíaco influenciaram as complicações não fatais nas próteses 1G, enquanto complicações das próteses 2G associaram-se ao gênero feminino (39,6%
vs.
30,4%, p= 0,003).

A mortalidade intra-hospitalar na população do RIBAC-NT associou-se diretamente a complicações do procedimento, principalmente CV maior e IRA. A ocorrência de complicações não fatais diferiu conforme o gênero e o tipo da bioprótese.

Transcatheter aortic valve implantation (TAVI) has had an exponential increase of its indication, being incorporated into the Brazilian Unified Public Health System in 2022, thus requiring assessment of its use in Brazil.

To assess the factors associated with in-hospital mortality and non-fatal complications in both genders in the Brazilian Registry of Transcatheter Aortic Valve Implantation and New Technologies (RIBAC-NT) population.

Analysis of the RIBAC-NT database from 2008 to 2022 was performed. Logistic models and machine learning were used for statistical assessment of the association between variables and outcomes. The software R was used and a 5% significance level, adopted.

Analysis of 2588 patients (women, 51.2%; in-hospital death, 8.2%). Mortality was associated with procedural complications, of which major vascular complication (VC) and acute kidney injury (AKI) stood out (p<0.001). Major VC occurred in 6% of the patients, with 34% mortality; AKI occurred in 8.8%, with 13% mortality, which increased up to 8 times when AKI coexisted with other complications. Non-fatal complications occurred in 50.5% of all patients, affecting 63% of those with 1stgeneration (1G) bioprosthesis and 39% of those with 2ndgeneration (2G) bioprosthesis (p<0,001). Non-femoral access and heart rhythm influenced non-fatal complications in patients with 1G prostheses, while complications in patients with 2G prosthesis associated with the female gender (39.6% vs. 30.4%, p=0.003).

In-hospital mortality in the RIBAC-NT population was directly associated with procedural complications, mainly major VC and AKI. The occurrence of non-fatal complications differed according to gender and bioprosthesis type.