Clinical Trial – ABC CARDIOL

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Original Article

Esophageal Temperature Monitoring during Atrial Fibrillation Ablation: A Randomized Study

Daniel Moreira Costa Moura et al. Renner Augusto Raposo Pereira Cristiano Faria Pisani Tan Chen Wu … Muhieddine Omar Chokr Carina Abigail Hardy Sissy Lara de Melo Francisco Carlos da Costa Darrieux Denise Tessariol Hachul Mauricio Ibrahim Scanavacca

Abstract

Background

Pulmonary vein isolation (PVI) for atrial fibrillation (AF) ablation carries a risk of esophageal thermal injury (ETI), which can lead to severe complications.

Objective

To evaluate three luminal esophageal temperature (LET) monitoring strategies and assess their effectiveness in reducing the incidence of ETI.

Methods

Patients with AF were randomized into three PVI groups according to the temperature monitoring strategy: no LET monitoring (Group 1), LET monitoring with a single-sensor probe (SSP) thermometer (Group 2), and LET monitoring with a multisensor probe (MSP) thermometer (Group 3). In Group 1, AF ablation was performed at a fixed power of 20 W on the left atrial posterior wall. In Groups 2 and 3, AF ablation power was titrated based on LET measurements, with a cutoff temperature of 37.5 °C. Each group included 20 patients. A two-sided p-value <0.05 was considered statistically significant. The trial was registered on ClinicalTrials.gov (#NCT03645070) and International Clinical Trials Registry Platform (#RBR-2yvgyf).

Results

All patients underwent PVI and esophagogastroduodenoscopy. No ETI was observed in patients monitored with an MSP thermometer. In contrast, five patients without LET monitoring and six patients monitored with an SSP thermometer developed ETI (p=0.006). Higher temperatures were recorded with an MSP thermometer (37.9 vs. 38.45 °C, p=0.018). There were no significant differences in PVI duration or total radiofrequency application time (p=0.250 and p=0.253, respectively).

Conclusions

LET monitoring with an MSP thermometer during PVI significantly reduces the incidence of ETI compared to no monitoring or SSP monitoring. Implementing advanced LET monitoring strategies may enhance patient safety without compromising procedural efficiency.

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Original Article

Patisiran Treatment in the Brazilian Subpopulation of the Phase 3 APOLLO-B Study in Transthyretin Amyloidosis with Cardiomyopathy: Post Hoc Analysis

Claudio Tinoco Mesquita et al. Pedro Schwartzmann Edileide Barros Correia Marcus V. Simões … Andreia Biolo Daniel Rodriguez Duque Patrick Y. Jay Fábio Fernandes

Abstract

Background

Patisiran rapidly knocked down transthyretin and preserved functional capacity in patients with transthyretin amyloidosis with cardiomyopathy (ATTR-CM) in the global Phase 3 APOLLO-B study (NCT03997383).

Objectives

To evaluate patisiran efficacy and safety in post hoc analysis of the Brazilian subpopulation of APOLLO-B.

Methods

Patients were randomized 1:1 to patisiran 0.3 mg/kg or placebo every 3 weeks for 12 months. The primary endpoint was the change from baseline (CFB) in functional capacity (6-minute walk test [6MWT]) at Month 12. Secondary endpoints included CFB to Month 12 in the Kansas City Cardiomyopathy Questionnaire-Overall Summary (KCCQ-OS) score. Exploratory endpoints included CFB in cardiac biomarkers and Perugini grade of cardiac uptake during technetium-99m scintigraphy.

Results

Forty-two patients enrolled in Brazil (patisiran, n=20; placebo, n=22). Patisiran showed benefit in 6MWT and KCCQ-OS scores vs. placebo; CFB (95% confidence interval [CI]) in 6MWT (median) and KCCQ-OS scores (least squares mean) was –2.0 m (–58.5, 42.9) and 9.37 (1.93, 16.81) points with patisiran vs. –30.1 m (–72.2, 3.5) and 2.62 (–4.68, 9.92) points for placebo. For cardiac biomarkers, the mean fold-change from baseline (95% CI) for N-terminal prohormone B-type natriuretic peptide and troponin I was 1.31 (1.06, 1.61) and 1.12 (0.94, 1.34) for patisiran, and 1.71 (1.39, 2.10) and 1.28 (1.08, 1.53) for placebo, respectively. Perugini grade improved in 11/18 (61.1%) and 0/10 evaluable patients with patisiran and placebo, respectively. There were no deaths in the patisiran group vs. 3 in the placebo group.

Conclusion

The efficacy and safety of patisiran in Brazilian patients with ATTR-CM in APOLLO-B were consistent with those in the global study population. Findings are descriptive due to the small number of patients.

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Editorial

Chronic Coronary Syndrome: What to Expect from Investigation and Management After ISCHEMIA?

Lucas Cronemberger Maia Mendes et al. Rafael Willain Lopes Rodrigo Julio Cerci Simone Cristina Soares Brandão

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Special Article

Data Sharing: A New Editorial Initiative of the International Committee of Medical Journal Editors. Implications for the Editors´ Network

Fernando Alfonso et al. Karlen Adamyan Jean-Yves Artigou Michael Aschermann … Michael Boehm Alfonso Buendia Pao-Hsien Chu Ariel Cohen Livio Dei Cas Mirza Dilic Anton Doubell Dario Echeverri Nuray Enç Ignacio Ferreira-González Krzysztof J. Filipiak Andreas Flammer Eckart Fleck Plamen Gatzov Carmen Ginghina Lino Goncalves Habib Haouala Mahmoud Hassanein Gerd Heusch Kurt Huber Ivan Hulín Mario Ivanusa Rungroj Krittayaphong Chu-Pak Lau Germanas Marinskis François Mach Luiz Felipe Moreira Tuomo Nieminen Latifa Oukerraj Stefan Perings Luc Pierard Tatjana Potpara Walter Reyes-Caorsi Se-Joong Rim Olaf Rødevand Georges Saade Mikael Sander Evgeny Shlyakhto Bilgin Timuralp Dimitris Tousoulis Dilek Ural J. J. Piek Albert Varga Thomas F. Lüscher

Abstract

The International Committee of Medical Journal Editors (ICMJE) provides recommendations to improve the editorial standards and scientific quality of biomedical journals. These recommendations range from uniform technical requirements to more complex and elusive editorial issues including ethical aspects of the scientific process. Recently, registration of clinical trials, conflicts of interest disclosure, and new criteria for authorship – emphasizing the importance of responsibility and accountability-, have been proposed. Last year, a new editorial initiative to foster sharing of clinical trial data was launched. This review discusses this novel initiative with the aim of increasing awareness among readers, investigators, authors and editors belonging to the Editors´ Network of the European Society of Cardiology.

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Original Article

Kinetics of Hypotension during 50 Sessions of Resistance and Aerobic Training in Hypertensive Patients: a Randomized Clinical Trial

Igor Rodrigues Damorim et al. Tony Meireles Santos Gustavo Willames Pimentel Barros Paulo Roberto Cavalcanti Carvalho

Abstract

Background:

Resistance and aerobic training are recommended as an adjunctive treatment for hypertension. However, the number of sessions required until the hypotensive effect of the exercise has stabilized has not been clearly established.

Objective:

To establish the adaptive kinetics of the blood pressure (BP) responses as a function of time and type of training in hypertensive patients.

Methods:

We recruited 69 patients with a mean age of 63.4 ± 2.1 years, randomized into one group of resistance training (n = 32) and another of aerobic training (n = 32). Anthropometric measurements were obtained, and one repetition maximum (1RM) testing was performed. BP was measured before each training session with a digital BP arm monitor. The 50 training sessions were categorized into quintiles. To compare the effect of BP reduction with both training methods, we used two-way analysis of covariance (ANCOVA) adjusted for the BP values obtained before the interventions. The differences between the moments were established by one-way analysis of variance (ANOVA).

Results:

The reductions in systolic (SBP) and diastolic BP (DBP) were 6.9 mmHg and 5.3 mmHg, respectively, with resistance training and 16.5 mmHg and 11.6 mmHg, respectively, with aerobic training. The kinetics of the hypotensive response of the SBP showed significant reductions until the 20th session in both groups. Stabilization of the DBP occurred in the 20th session of resistance training and in the 10th session of aerobic training.

Conclusion:

A total of 20 sessions of resistance or aerobic training are required to achieve the maximum benefits of BP reduction. The methods investigated yielded distinct adaptive kinetic patterns along the 50 sessions.

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Original Article

Blood Pressure Treatment Adherence and Control after Participation in the ReHOT

Nathália Silva de Jesus et al. Armando da Rocha Nogueira Cacilda Oliveira Pachu Ronir Raggio Luiz Glaucia Maria Moraes de Oliveira

Abstract

Background:

Lack of adherence to pharmacological treatment is one of the main causes of low control rates in hypertension.

Objective:

To verify treatment adherence and associated factors, as well as blood pressure (BP) control in participants of the Resistant Hypertension Optimal Treatment (ReHOT) clinical trial.

Method:

Cross-sectional study including all 109 patients who had completed the ReHOT for at least 6 months. We excluded those participants who failed to respond to the new recruitment after three phone contact attempts. We evaluated the BP control by ambulatory BP monitoring (ABPM; controlled levels: 24-hour systolic and diastolic BP < 130 x 80 mmHg) and analyzed the patients' treatment adherence using the Morisky Medication Adherence Scale (MMAS) questionnaire validated by Bloch, Melo, and Nogueira (2008). The statistical analysis was performed with the software IBM SPSS statistics 21.0. We tested the normality of the data distribution with kurtosis and skewness. The variables tested in the study are presented with descriptive statistics. Comparisons between treatment adherence and other variables were performed with Student's t test for independent variables and Pearson's chi-square or Fisher's exact test. To conduct analyses among patients considering adherence to treatment and BP control, we created four groups: G0, G1, G2, and G3. We considered a 5% significance level in all tests.

Results:

During the ReHOT, 80% of the patients had good BP control and treatment adherence. Of 96 patients reevaluated in the present study, only 52.1% had controlled hypertension when assessed by ABPM, while 31.3% were considered adherent by the MMAS. Regarding other ABPM measures, we observed an absence of a nocturnal dip in 64.6% of the patients and a white-coat effect and false BP control in 23% and 12.5%, respectively. Patients’ education level showed a trend towards being a determinant factor associated with lack of adherence (p = 0.05). Resistant hypertension and number of medications were significantly associated with BP control assessed by ABPM (p = 0.009 and p = 0.001, respectively). Resistant hypertension was also significantly associated with group G0 (patients with no control or adherence, p = 0.012).

Conclusion:

There was a decrease in BP control and adherence measured by the MMAS after participation of at least 6 months in the ReHOT clinical trial.

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Original Article

Quality of Life on Arterial Hypertension: Validity of Known Groups of MINICHAL

Ana Lúcia Soares Soutello et al. Roberta Cunha Matheus Rodrigues Fernanda Freire Jannuzzi Thaís Moreira São-João … Gabriela Giordano Martinix Wilson Nadruz Jr. Maria-Cecília Bueno Jayme Gallani

Introductions:

In the care of hypertension, it is important that health professionals possess available tools that allow evaluating the impairment of the health-related quality of life, according to the severity of hypertension and the risk for cardiovascular events. Among the instruments developed for the assessment of health-related quality of life, there is the Mini-Cuestionario of Calidad de Vida en la Hipertensión Arterial (MINICHAL) recently adapted to the Brazilian culture.

Objective:

To estimate the validity of known groups of the Brazilian version of the MINICHAL regarding the classification of risk for cardiovascular events, symptoms, severity of dyspnea and target-organ damage.

Methods:

Data of 200 hypertensive outpatients concerning sociodemographic and clinical information and health-related quality of life were gathered by consulting the medical charts and the application of the Brazilian version of MINICHAL. The Mann-Whitney test was used to compare health-related quality of life in relation to symptoms and target-organ damage. The Kruskal-Wallis test and ANOVA with ranks transformation were used to compare health-related quality of life in relation to the classification of risk for cardiovascular events and intensity of dyspnea, respectively.

Results:

The MINICHAL was able to discriminate health-related quality of life in relation to symptoms and kidney damage, but did not discriminate health-related quality of life in relation to the classification of risk for cardiovascular events.

Conclusion:

The Brazilian version of the MINICHAL is a questionnaire capable of discriminating differences on the health‑related quality of life regarding dyspnea, chest pain, palpitation, lipothymy, cephalea and renal damage.

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Artigo Original

Hydration with sodium bicarbonate does not prevent contrast nephropathy: a multicenter clinical trial

Vitor O. Gomes et al. Ricardo Lasevitch Valter C. Lima Fábio S. Brito Jr. … Juan Carlos Perez-Alva Bruno Moulin Airton Arruda Denise Oliveira Paulo Caramori

BACKGROUND: Radiographic contrast media exposition can cause acute renal function impairment. There is limited and conflicting evidence that hydration with sodium bicarbonate prevents contrast-induced nephropathy (CIN) in patients undergoing cardiac catheterization. OBJECTIVE: The present study was aimed at determining whether sodium bicarbonate is superior to hydration with saline to prevent nephropathy in patients at risk undergoing cardiac catheterization. METHODS: Three hundred and one patients undergoing coronary angiography or percutaneous coronary intervention with serum creatinine > 1.2mg/dL or glomerular filtration rate (GFR) < 50ml/min were randomized to receive hydration with sodium bicarbonate starting 1 hour before the procedure and 6 hours after the procedure, or hydration with 0.9% saline. CIN was defined as an increase of 0.5mg/dL in creatinine in 48h RESULTS: Eighteen patients (5.9%) developed contrast induced nephropathy: 9 patients in the bicarbonate group (6.1%) and 9 patients in the saline group (6.0%), p = 0.97. The change in serum creatinine was similar in both groups, 0.01 ± 0.26 mg/dL in the bicarbonate group and 0.01 ± 0.35 mg/dL in the saline group, p = 0.9. No statistical difference was observed between the change in glomerular filtration rate (0.89 ± 9 ml/min vs. 2.29 ± 10 ml/min, p = 0.2 bicarbonate group and saline group, respectively). CONCLUSION: Hydration with sodium bicarbonate was not superior to saline to prevent contrast media induced nephropathy in patients at risk undergoing cardiac catheterization.

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Artigo Original

Education and telephone monitoring by nurses of patients with heart failure: randomized clinical trial

Fernanda B Domingues et al. Nadine Clausell Graziella B Aliti Daniela R Dominguez Eneida R Rabelo

BACKGROUND: Nursing approaches to manage patients with heart failure (HF) showed benefits in reducing the morbidity and mortality. However, combining intra-hospital education with telephone contact after hospital discharge has been little explored. OBJECTIVE: To compare two nursing intervention groups among patients hospitalized due to decompensated HF: the intervention group (IG) received educational nursing intervention during hospitalization followed by telephone monitoring after discharge and the control group (CG) received in-hospital intervention only. Outcomes were levels of HF and self-care knowledge, the frequency of visits to the emergency room, rehospitalizations and deaths in a three-month period. METHODS: Randomized clinical trial. We studied adult HF patients with left ventricle ejection fraction (LVEF) < 45% who could be contacted by telephone after discharge. HF awareness was evaluated through a standardized questionnaire that also included questions regarding self-care knowledge, which was answered during the hospitalization period and three months later. For patients in the IG group contacts were made using phone calls and final interviews were conducted in both groups at end of the study. RESULTS: Forty-eight patients were assigned to the IG and 63 to the CG. Mean age (63 ± 13 years) and L (around 29%) were similar in the two groups. Scores for HF and self-care knowledge were similar at baseline. Three months later, both groups showed significantly improved HF awareness and self-care knowledge scores (P < 0.001). Other outcomes were similar. CONCLUSION: An in-hospital educational nursing intervention benefitted all HF patients in understanding their disease, regardless of telephone contact after discharge.

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