Sex-Specific Disparities in Clinical Outcomes After Transcatheter Aortic Valve Replacement Among Different Racial Populations.

Background: Sex-related disparities in clinical outcomes following transcatheter aortic valve replacement (TAVR) and the impact of sex on clinical outcomes after TAVR among different racial groups are undetermined. Objectives: This study assessed whether sex-specific differences in baseline clinical and anatomical characteristics affect clinical outcomes after TAVR and investigated the impact of sex on clinical outcomes among different racial groups. Methods: The TP-TAVR (Trans-Pacific TAVR) registry is a multinational cohort study of patients with severe aortic stenosis who underwent TAVR at 2 major centers in the United States and 1 major center in South Korea. The primary outcome was a composite of death from any cause, stroke, or rehospitalization after 1 year. Results: The incidence of the primary composite outcome was not significantly different between sexes (27.9% in men vs 28% in women; adjusted HR: 0.97; 95% CI: 0.79-1.20). This pattern was consistent in Asian (23.5% vs 23.3%; adjusted HR: 0.99; 95% CI: 0.69-1.41) and non-Asian (30.8% vs 31.6%; adjusted HR: 0.95; 95% CI: 0.72-1.24) cohorts, without a significant interaction between sex and racial group (P for interaction = 0.74). The adjusted risk for all-cause mortality was similar between sexes, regardless of racial group. However, the adjusted risk of stroke was significantly lower in male patients than in female patients, which was more prominent in the non-Asian cohort. Conclusions: Despite significantly different baseline and procedural characteristics, there were no sex-specific differences in the adjusted 1-year rates of primary composite outcomes and all-cause mortality, regardless of different racial groups. (Transpacific TAVR registry [TP-TAVR]; NCT03826264).

Importância dos estudos pré-clínicos em animais de experimentação para a cardiologia intervencionista: [revisão] / The importance of pre-clinical animal testing in interventional cardiology: [review]

O tratamento da doença cardiovascular mudou radicalmente nas últimas duas décadas, proporcionando aos pacientes uma sobrevida maior e melhor qualidade de vida. Grande parte desse sucesso deve-se à introdução de novas terapias. Em nenhuma outra área essa mudança foi mais evidente do que na cardiologia intervencionista, pois nos últimos vinte anos as intervenções cardiovasculares percutâneas saíram do terreno experimental para formar a base terapêutica dos portadores de doença cardiovascular sintomática. O desenvolvimento dessas tecnologias, desde os primeiros estágios, requer a realização de estudos pré-clínicos com modelos animais. É possível compreender os mecanismos terapêuticos desses dispositivos, uma vez introduzidos na esfera clínica, comparando-se os achados das pesquisas realizadas com modelos animais com amostras de exames anatomopatológicos. Esta análise apresenta uma visão geral do papel emergente dos estudos pré-clínicos, bem como dos resultados, do desenvolvimento e da avaliação de modelos amimais, nas tecnologias de intervenção cardiovascular percutânea para tratamento de pacientes com doença cardiovascular sintomática.

The treatment of cardiovascular disease has changed dramatically over the past 2 decades, allowing patients to live longer and better quality lives. The introduction of new therapies has contributed much to this success. Nowhere has this been more evident than in interventional cardiology, where percutaneous cardiovascular intervention has evolved in the past 2 decades from a quirky experimental procedure to a therapeutic cornerstone for patients with symptomatic cardiovascular disease. The development of these technologies from the earliest stages requires preclinical experiments using animal models. Once introduced into the clinical arena, an understanding of therapeutic mechanisms of these devices can be ascertained through comparisons of animal model research findings with clinical pathological specimens. This review provides an overview of the emerging role, results of preclinical studies and development, and evaluation of animal models for percutaneous cardiovascular intervention technologies for patients with symptomatic cardiovascular disease.

Efficacy and fesibility of Helixcision for debulking neointimal hyperplasia for in-stent restenosis

The helixcision system is a novel 6 Fr-compatible catheter designed to debulk tissue for in stent restenosis lesions. The purpose of this study was to determine the efficacy and feasibility of this new system for removing neointimal hyperplasia. A total of 32 in-stent restenosis lesions in 32 patients were treated with helixcision followed ballon angioplasty. Debulking efficacy was assessed with serial baseline intravascular ultrasound (IVUS) in a subset of 18 lesions. To investigate longitudnal efficacy, 3D analyisis was also performed in 12 lesions with automated pullback to calculate average cross-sectional areas across the stent...

Adequacy of intracoronary versus intravenous adenosine-induced maximal coronary hyperemiafor fractional flow reserve measurements

Fractional flow reserve (FFR) is a measure of coronary stenosis severity that is based on pressure measurements obtained at maximal hyperemia. The most widely used pharmacologic stimulus for maximal coronary hyperemia is adenosine, administered either as a continuous intravenous (IV) infusion or intracoronary (IC) bolus. IV adenosine has more side effects and is more costly than IC adenosine but has a more stable and prolonged hyperemic effect.Methods We compared the efficacy of IC and IV adenosine administration for the measurement of FFR in a multicentertrial. Fifty-two patients with 60 lesions underwent determination of FFR with both IV and IC adenosine. IV adenosine was administered as a continuous infusion at a rate of 140 μg/kg per minute until a steady state hyperemia was achieved. IC adenosine boluses were administered at a dose of 15 to 20 μg in the right and 18 to 24 μg in the left coronary artery. FFR was calculated as the ratio of the distal coronary pressure (from pressure guide wire) to the aortic pressure (guide catheter)at maximal hyperemia.Results A total of 26 left anterior descending, 23 right, 9 left circumflex, and 3 left main coronary arteries were evaluated. Mean percent stenosis for both groups was 55.8% ± 23.6% (range 0% to 95%), and mean FFR was 0.78 ± 0.15 (range 0.41 to 0.98). There was a strong and linear correlation between FFR measurements with IV and IC adenosine (R =0.978, y = 0.032 + 0.964x, P < .001). The agreement between the 2 sets of measurements was also high, with a mean differencein FFR of –0.004 ± 0.03. However, a small random scatter in both directions of FFR measurements was noted with5 lesions (8.3%) where FFR with IC adenosine was higher by 0.05 or more compared with IV infusions, suggesting a suboptimal hyperemic response in these patients...