Characterization and Management of Stable Coronary Artery Disease in Patients Undergoing Transcatheter Aortic Valve Implantation.

Background/Objectives: To date, data regarding the characteristics and management of obstructive, stable coronary artery disease (CAD) encountered in patients undergoing transcatheter aortic valve implantation (TAVI) are sparse. The aim of the study was to analyze granular details, treatment, and outcomes of patients undergoing TAVI with obstructive, stable CAD from real-world practice. Methods: REVASC-TAVI (Management of myocardial REVASCularization in patients undergoing Transcatheter Aortic Valve Implantation with coronary artery disease) is an investigator-initiated, multicenter registry, which collected data from patients undergoing TAVI with obstructive stable CAD found during the pre-TAVI work-up. Results: A total of 2025 patients from 30 centers worldwide with complete follow-up were included in the registry. Most patients had single-vessel CAD (56.1%). An involvement of proximal coronary tracts was detected in 62.5% of cases, with 12.0% of patients having CAD in left main (LM). Most patients received percutaneous coronary intervention (PCI) (n = 1617, 79.9%), especially those with proximal CAD (90.4%). At 2 years, the rates of all-cause death [Kaplan-Meier (KM) estimates 20.1% vs. 18.8%, plog-rank = 0.86] and of the composite of all-cause death, stroke, myocardial infarction, and rehospitalization for heart failure (KM estimates 29.7% vs. 27.5%, plog-rank = 0.82) did not differ between patients undergoing PCI and those who were not. Conclusions: Patients undergoing TAVI with obstructive CAD more commonly had a single-vessel disease and an involvement of proximal coronary tracts. They were commonly treated with PCI, with similar outcomes compared to those treated conservatively.

Characterization of a New Variant in ARHGAP31 Probably Involved in Adams-Oliver Syndrome in a Family with a Variable Phenotypic Spectrum.

Adams-Oliver syndrome is a rare inherited condition characterized by scalp defects and limb abnormalities. It is caused by variants in different genes such as ARHGAP31. Here, we used an interdisciplinary approach to study a family with lower limb anomalies. We identified a novel variant in the ARHGAP31 gene that is predicted to result in a truncated protein with a constitutively activated catalytic site due to the loss of 688 amino acids involved in the C-terminal domain, essential for protein auto-inhibition. Pathogenic variants in ARHGAP31 exon 12, leading to a premature protein termination, are associated with Adams-Oliver syndrome. Bioinformatic analysis was useful to elucidate the impact of the identified genetic variant on protein structure. To better understand the impact of the identified variant, 3D protein models were predicted for the ARHGAP31 wild type, the newly discovered variant, and other pathogenetic alterations already reported. Our study identified a novel variant probably involved in Adams-Oliver syndrome and increased the evidence on the phenotypic variability in patients affected by this syndrome, underlining the importance of translational research, including experimental and bioinformatics analyses. This strategy represents a successful model to investigate molecular mechanisms involved in syndrome occurrence.

Late Third Transcatheter Aortic Valve Replacement for Treatment of Persistent Paravalvular Regurgitation.

Paravalvular regurgitation remains a frequent finding after transcatheter aortic valve replacement and is associated with unfavorable outcomes if more-than-mild grade. In this case, a patient underwent a third transcatheter aortic valve replacement procedure for worsening symptoms due to severe paravalvular regurgitation. The case underlines the role of preprocedural planning in achieving treatment success.

Coronary Cannulation Following TAVR Using Self-Expanding Devices With Commissural Alignment: The RE-ACCESS 2 Study.

BACKGROUND: Coronary re-engagement after transcatheter aortic valve replacement (TAVR) using self-expanding transcatheter heart valves (THVs) systematically implanted using commissural alignment (CA) techniques has been poorly investigated. OBJECTIVES: The aim of this study was to evaluate unsuccessful coronary cannulation, and its predictors, after TAVR using self-expanding devices implanted using CA techniques. METHODS: RE-ACCESS 2 (Reobtain Coronary Ostia Cannulation Beyond Transcatheter Aortic Valve Stent 2) was an investigator-driven, single-center, prospective study that enrolled consecutive TAVR patients receiving Evolut and ACURATE THVs implanted using CA techniques. The primary endpoint was unsuccessful coronary cannulation after TAVR. The secondary endpoint was the identification of postprocedural predictors of unfeasible, selective coronary ostia re-engagement on computed tomographic angiography performed after TAVR. RESULTS: Among 127 patients enrolled from September 2021 to December 2022, 7 (5.5%) had unsuccessful coronary cannulation after TAVR, and 6 of them received Evolut THVs (7.5% vs 2.3%; P = 0.26). Failure of left coronary artery cannulation was similar between Evolut and ACURATE THVs (2.5% vs 2.1%; P = 1.00), whereas that of right coronary artery cannulation was prevalent in the Evolut group (6.3% vs 0.0%; P = 0.16). Coronary overlap was associated with the inability to selectively cannulate the right coronary artery (OR: 5.6; 95% CI: 1.2-25.8; P = 0.03), but not in ACURATE recipients (P = 0.39). Severe misalignment of Evolut THVs was associated with the inability to selectively cannulate both coronary arteries (OR: 24.7; 95% CI: 1.9-312.9; P = 0.01). CONCLUSIONS: Unsuccessful coronary cannulation after TAVR using self-expanding THVs implanted using CA techniques was reported in 5.5% of cases, with the majority involving the Evolut THV. Commissural misalignment affected coronary cannulation after TAVR mostly in Evolut recipients.

Comparison of two self-expanding transcatheter heart valves for degenerated surgical bioprostheses: the AVENGER multicentre registry.

BACKGROUND: There is a lack of comparative data on transcatheter aortic valve implantation (TAVI) in degenerated surgical prostheses (valve-in-valve [ViV]). AIMS: We sought to compare outcomes of using two self-expanding transcatheter heart valve (THV) systems for ViV. METHODS: In this retrospective multicentre registry, we included consecutive patients undergoing transfemoral ViV using either the ACURATE neo/neo2 (ACURATE group) or the Evolut R/PRO/PRO+ (EVOLUT group). The primary outcome measure was technical success according to Valve Academic Research Consortium (VARC)-3. Secondary outcomes were 30-day all-cause mortality, device success (VARC-3), coronary obstruction (CO) requiring intervention, rates of severe prosthesis-patient mismatch (PPM), and aortic regurgitation (AR) ≥moderate. Comparisons were made after 1:1 propensity score matching. RESULTS: The study cohort comprised 835 patients from 20 centres (ACURATE n=251; EVOLUT n=584). In the matched cohort (n=468), technical success (ACURATE 92.7% vs EVOLUT 88.9%; p=0.20) and device success (69.7% vs 73.9%; p=0.36) as well as 30-day mortality (2.8% vs 1.6%; p=0.392) were similar between the two groups. The mean gradients and rates of severe PPM, AR ≥moderate, or CO did not differ between the groups. Technical and device success were higher for the ACURATE platform among patients with a true inner diameter (ID) >19 mm, whereas a true ID ≤19 mm was associated with higher device success - but not technical success - among Evolut recipients. CONCLUSIONS: ViV TAVI using either ACURATE or Evolut THVs showed similar procedural outcomes. However, a true ID >19 mm was associated with higher device success among ACURATE recipients, whereas in patients with a true ID ≤19 mm, device success was higher when using Evolut.

Evolut PRO and SAPIEN ULTRA Performance in Small Aortic Annuli: The OPERA-TAVI Registry.

BACKGROUND: The performance of latest iteration transcatheter aortic valve replacement platforms in patients with small aortic anatomy remains underexplored. OBJECTIVES: The aim of this study was to evaluate effectiveness and performance between the self-expanding (SE) Evolut PRO and PRO+ and the balloon-expandable (BE) SAPIEN ULTRA in patients with small aortic annuli. METHODS: Data from the OPERA-TAVI (Comparative Analysis of Evolut PRO vs. SAPIEN 3 ULTRA Valves for Transfemoral Transcatheter Aortic Valve Implantation) registry were used, with 1:1 propensity score matching. Primary endpoints included 1-year effectiveness composite (all-cause mortality, disabling stroke, or heart failure hospitalization) and 30-day device-related (hemodynamic structural valve dysfunction and nonstructural valve dysfunction) outcomes. RESULTS: Among 3,516 patients, 251 matched pairs with aortic annular area <430 mm2 were assessed. The 1-year primary effectiveness outcome did not differ significantly between cohorts (SE 10.8% vs BE 11.2%; P = 0.91). The 30-day device-oriented composite outcome was more favorable in the Evolut PRO group (SE 4.8% vs BE 10.4%; P = 0.027). Notably, SE valve recipients showed higher rates of disabling stroke (SE 4.0% vs BE 0.0%; P < 0.01) and paravalvular leaks (mild or greater: SE 48.5% vs BE 18.6% [P < 0.001]; moderate: SE 4.5% vs BE 1.2% [P = 0.070]). The BE group had higher rates of prosthesis-patient mismatch (moderate or greater: SE 16.0% vs BE 47.1% [P < 0.001]; severe: SE 1.3% vs BE 5.7% [P = 0.197]) and more patients with residual mean gradients >20 mm Hg (SE 1.0% vs BE 13.5%; P < 0.001). CONCLUSIONS: In patients with small aortic annuli, transcatheter aortic valve replacement with latest iteration devices is safe. SE platforms are associated with more favorable device performance in terms of hemodynamic structural and nonstructural dysfunction. Randomized data are needed to validate these findings and guide informed device selection.

Sex-Related Outcomes of Transcatheter Aortic Valve Implantation With Self-Expanding or Balloon-Expandable Valves: Insights from the OPERA-TAVI Registry.

Evidence regarding gender-related differences in response to transcatheter aortic valve implantation according to the valve type is lacking. This study aimed to evaluate the impact of gender on the treatment effect of Evolut PRO/PRO+ (PRO) or SAPIEN 3 Ultra (ULTRA) devices on clinical outcomes. The Comparative Analysis of Evolut PRO vs SAPIEN 3 Ultra Valves for Transfemoral Transcatheter Aortic Valve Implantation (OPERA-TAVI) is a multicenter, multinational registry including patients who underwent the latest-iteration PRO or ULTRA implantation. Overall, 1,174 of 1,897 patients were matched based on valve type and compared according to gender, whereas 470 men and 630 women were matched and compared according to valve type. The 30-day and 1-year outcomes were evaluated. In the PRO and ULTRA groups, men had a higher co-morbidity burden, whereas women had smaller aortic root. The 30-day (device success [DS], early safety outcome, permanent pacemaker implantation, patient-prosthesis mismatch, paravalvular regurgitation, bleedings, vascular complications, and all-cause death) and 1-year outcomes (all-cause death, stroke, and heart failure hospitalization) did not differ according to gender in both valve groups. However, the male gender decreased the likelihood of 30-day DS with ULTRA versus PRO (p for interaction = 0.047). A higher risk of 30-day permanent pacemaker implantation and 1-year stroke and a lower risk of patient-prosthesis mismatch was observed in PRO versus ULTRA, regardless of gender. In conclusion, gender did not modify the treatment effect of PRO versus ULTRA on clinical outcomes, except for 30-day DS, which was decreased in men (vs women) who received ULTRA (vs PRO).

Implementação da humanização da assistência ao parto natural / Implementation of humanized care to natural childbirth / Implementación de la humanización de la asistencia al parto natural

Objetivo: analisar a implementação das práticas humanizadas na assistência ao parto natural, fundamentada no documento "Boas práticas de atenção ao parto e ao nascimento” de 1996. Método: estudo transversal, descritivo, realizado com 51 puérperas, em alojamento conjunto de hospital municipal de Fortaleza (CE), Brasil, de setembro a outubro de 2013, por meio de questionário. Resultados: 35,29% das mulheres tinham entre 20 e 25 anos, 64,71% não concluíram o ensino médio e 76,47% relataram renda mensal de um salário. Destacaram-se práticas eficazes de atenção ao parto e ao nascimento: apoio empático pelos profissionais (92,16%); uso de métodos não farmacológicos no alívio da dor (90,20%); liberdade de posição durante o trabalho de parto (74,51%); e práticas inadequadas: cateterização venosa profilática (64,7%), pressão do fundo uterino (62,7%) e transferência da parturiente para outra sala no segundo estágio do trabalho de parto(82,3%). Conclusão: as recomendações preconizadas foram realizadas, no entanto, apesar das limitações existentes, urge oferta de recursos disponíveis a parturientes, respeitando a liberdade de escolha destas.(AU)

Objective: to analyze the implementation of humanized practices in assisting the natural childbirth, based on the document "Good care practices for labor and birth", of 1996. Method: cross-sectional descriptive study conducted with 51 mothers in a rooming-in of a municipal hospital in Fortaleza (CE), Brazil, from September to October 2013, using a questionnaire. Results: 35.29% of women were between 20 and 25 years old, 64.71% have not completed high school and 76.47% reported monthly income of one salary. Effective practices of care during labor and birth stood out: empathic support by professionals (92.16%); use of non-pharmacological methods to relieve pain (90.20%); freedom of position during labor (74.51%); and inadequate practices: prophylactic venous catheterization (64.7%), pressure of the uterine fundus (62.7%) and transferring the woman to another room on the second stage of labor (82 3%). Conclusion: the proposed recommendations were performed. However, despite the existing limitations, there is urgent need of providing resources to pregnant women, respecting their freedom of choice.(AU)

Objetivo: analizar la implementación de las prácticas humanizadas en la asistencia al parto natural, fundamentada en el documento "Buenas prácticas de atención al parto y al nacimiento" de 1996. Método: estudio transversal, descriptivo, realizado con 51 puérperas, en alojamiento conjunto de un hospital municipal de Fortaleza (CE), Brasil, de septiembre a octubre de 2013, por medio de un cuestionario. Resultados: 35,29% de las mujeres tenían entre 20 y 25 años, 64,71% no concluyeron la enseñanza secundaria y 76,47% relataron renda mensual de un salario. Se destacaron prácticas eficaces de atención al parto y al nacimiento: apoyo empático por los profesionales (92,16%); uso de métodos no farmacológicos en el alivio del dolor (90,20%); libertad de posición durante el trabajo de parto (74,51%); y prácticas inadecuadas: cateterización venosa profiláctica (64,7%), presión del fundo uterino (62,7%) y transferencia de la parturiente para otra sala en la segundo etapa del trabajo de parto (82,3%). Conclusión: las recomendaciones preconizadas fueron realizadas, sin embargo, a pesar de las limitaciones existentes, urge oferta de recursos disponibles a parturientes, respetando la libertad de elección de estas.(AU)

Violence: sex workers / Violência: profissionais do sexo

Objective - This is a descriptive exploratory with a qualitative approach. Aimed to verify the perceptions of sex workers in developing its activities in relation to violence in the sexual, physical or emotional scope. Methods - The survey was conducted on the seafront in São Vicente municipality, SP, commonly used for local activities of sex workers, where the total sample consisted of 19 female sex workers. The procedures of data collection were recorded interviews mediated by an informal leader, a militant approach to education prevention of STD/ AIDS in the same city that is also sex worker. After collecting data, the interviews were transcribed and grouped into categories of analysis. Results - Were compared the results, on which it was observed that the females sex workers are more susceptible to suffer any kind of violence, in order that the female is more fragile, like the role of women in Brazilian society. It was observed that the vast majority of sex workers had suffered some type of violence, from physical to symbolic, being predominant the physical aggression. Conclusion - It is possible to state that the objectives were achieved and we hope that this research might contribute to improving the conditions of activity, aimed at awareness of society and reduce violence suffered by them.

Objetivo - Trata-se de uma pesquisa descritiva exploratória, de campo, com abordagem qualitativa. O objetivo foi verificar as percepções dos profissionais do sexo no desenvolvimento de suas atividades no que se refere às violências sejam de âmbito sexual, física ou emocional. Métodos - A pesquisa foi realizada na orla marítima no município de São Vicente, SP, local comumente utilizado para atividades das profissionais do sexo, sendo que a amostra total foi constituída de 19 profissionais do sexo do gênero feminino. Os procedimentos da coleta de dados foram de entrevistas gravadas mediada por uma líder informal, militante de um projeto educativo de prevenção de DST/AIDS do mesmo município que é também profissional do sexo. Após a coleta de dados, as entrevistas foram transcritas e agrupadas em categorias de análise. Resultados - Considerou-se frente aos resultados que as profissionais do sexo do gênero feminino são mais suscetíveis a sofrer qualquer tipo de violência, tendo em vista, que o sexo feminino é mais frágil, como o papel da mulher na sociedade brasileira. Verificou-se que a grande maioria das profissionais do sexo sofreu algum tipo de violência, desde simbólica até física, sendo predominante a agressão física. Conclusão - É possível afirmar que os objetivos foram atingidos, e espera-se que esta pesquisa possa vir a contribuir com a melhoria nas condições da atividade, visando à conscientização da sociedade e diminuição da violência sofrida por estas.