Safety – ABC CARDIOL

ABCIC

Original Article

Safety of dobutamine stress echocardiography using a modified protocol in a large unselected population

José Sebastião de Abreu et al. Tereza Cristina Pinheiro Diógenes Marília Esther Benevides Abreu Isadora Sucupira Machado Chagas … Sarah Gomes Diógenes Ana Gardenia Liberato Ponte Farias Marcia Maria Carneiro

Abstract

Background

Dobutamine stress echocardiography (DSE) using the conventional protocol (CP-DSE) may lead to important adverse effects.

Objective

This study was aimed at assessing the safety of DSE using a modified protocol (MP-DSE).

Methods

Data were collected from our institutional database to compare MP-DSE with the CP-DSE. In the CP-DSE, atropine could be administered during the fourth stage or its extension. In the MP-DSE, atropine was initiated at the beginning of the third stage, and there was no stage extension. Upon completion of DSE or for arrhythmia control, metoprolol was administered in the CP-DSE and esmolol in the MP-DSE. In cases of typical angina, nitroglycerin was administered at the examiner’s discretion in the CP-DSE, whereas its use was predetermined in the MP-DSE. A p-value < 0.05 was considered statistically significant.

Results

Of 17,811 tests performed, 9,121 were conducted using the MP-DSE. During DSE, myocardial oxygen consumption, represented by the rate-pressure product, was significantly higher in the MP-DSE group (22,530 ± 4,575 vs 23,037 ± 4,072 bpm.mmHg; p < 0.001). Hypertensive peak (1% vs 0.4%; p = 0.0001) and nonsustained ventricular tachycardia (0.6% vs 0.1%; p = 0.0001) were more frequent in the CP-DSE, while supraventricular tachyarrhythmia (2.1% vs 3.78%; p = 0.0001) and atrial fibrillation (0.8% vs 1.3%; p = 0.003) were more common in the MP-DSE. These arrhythmias resolved spontaneously or with medication. In the CP-DSE, two patients had ventricular fibrillation and one, acute coronary syndrome.

Conclusion

In our study, the modified protocol for DSE proved to be a safe option, with no severe adverse effects observed, despite the presence of an elevated rate-pressure product.

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Original Article

Pulsed Field Ablation Versus Very High-Power Short-Duration Radiofrequency Ablation in Atrial Fibrillation: A Systematic Review and Meta-Analysis

Asad Iqbal et al. Wellgner Fernandes Oliveira Amador Martin Cevallos-Cueva Maaz Ahmad … Juan Alejandro Pinilla Alarcón Radamés Vieira Diniz

Abstract

Background

Pulmonary vein isolation (PVI) is a cornerstone treatment for atrial fibrillation (AF). Pulsed-field ablation (PFA) and very high-power short-duration (vHPSD) radiofrequency (RF) ablation are emerging technologies, but their comparative efficacy and safety remain unclear.

Objectives

To assess the efficacy and safety of PFA compared to vHPSD RF ablation for AF.

Methods

A systematic search of PubMed, Embase, Web of Science, and Cochrane databases identified studies comparing PFA and vHPSD ablation. Outcomes included PVI success, skin-to-skin procedure time, fluoroscopy time, freedom from atrial arrhythmias, and complications such as cardiac tamponade, stroke, and vascular access events. Continuous outcomes were analyzed using mean differences (MD), while binary outcomes were assessed with risk ratios (RR) and 95% confidence intervals (CI). A significance threshold of p < 0.05 was considered for statistical analyses. This study is registered in PROSPERO (CRD42024619301).

Results

Four observational studies with 605 patients were included, of whom 315 (52%) underwent PFA. PFA and vHPSD achieved similar PVI success (RR 1.00; 95% CI 0.99–1.01; p = 1). PFA reduced procedure time (MD -30.07 min; 95% CI -31.41 to -28.74; p<0.01) but increased fluoroscopy time (MD 6.87 min; 95% CI 3.66–10.08; p<0.01). Freedom from atrial arrhythmias was comparable (RR 1.03; 95% CI 0.94–1.14; p=0.5). Complication rates, including cardiac tamponade, stroke, and vascular access issues, showed no significant differences between groups.

Conclusion

PFA significantly shortens procedure time but requires longer fluoroscopy compared to vHPSD. Both techniques exhibit comparable efficacy for PVI and arrhythmia freedom, with similar safety profiles.

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Review Article

Therapeutic Efficacy and Safety of Paracetamol versus Ibuprofen in Patent Ductus Arteriosus in Newborns: A Systematic Review

Halecy Davidson Sousa da Silva et al. Eryvelton de Souza Franco Larissa Caroline de Almeida Sousa Lima Maria Bernadete de Sousa Maia

ABSTRACT

Closure of the ductus arteriosus (DA) using cyclooxygenase (COX) inhibitors is considered the first-line treatment for hemodynamically significant patent ductus arteriosus (PDA). Physiologically, prostaglandins have a recognized role in PDA. Admittedly, the comparative efficacy and safety between ibuprofen and acetaminophen need to be determined for rational choice of drug therapy for closure of the DA in clinical protocols.

This study aims to present the aspects of the efficacy and therapeutic safety of paracetamol versus ibuprofen in the treatment of PDA in premature newborns.

A systematic review of the literature was carried out, following the recommendations of the PRISMA protocol, using the Medline, Pubmed, LILACS, and SciELO databases. Studies from the last 10 years (2013-2023) that analyzed the efficacy and/or safety of acetaminophen compared to ibuprofen in newborns diagnosed with PDA were included.

Eight randomized clinical trials (RCTs) were selected for analysis, resulting in a sample size of 781 newborns with PDA treated with acetaminophen or ibuprofen. The efficacy of acetaminophen for DA closure is comparable to ibuprofen. There is no statistically significant difference in the incidence of related adverse effects between the two drugs in most studies.

There is equivalence in the efficacy and safety of ibuprofen and acetaminophen to promote closure of the DA in premature newborns with hsPDA.

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Original Article

Study Design of a Brazilian Observational Study of Edoxaban in Patients with Atrial Fibrillation (EdoBRA)

Dalton Bertolim Précoma et al. Rafael Paletta da Silva Allyson Nakamoto Viviane Mariz Omar … Danilo Lopes José Francisco Kerr Saraiva

Abstract

Background:

Clinical trials showed the safety of Edoxaban, a non-vitamin K-dependent oral anticoagulant (NOAC), and its efficacy to prevent stroke and systemic embolism in non-valvular atrial fibrillation (NVAF) patients and also to prevent and treat venous thromboembolism. However, additional research is needed to evaluate the safety and effectiveness of Edoxaban in a real-world scenario in the Brazilian population.

Objective:

In order to understand the risks and benefits of Edoxaban use in routine clinical settings, the EdoBRA study is being conducted to gain insight into the safety and effectiveness of Edoxaban use in non-preselected patients with NVAF in Brazil.

Methods:

The EdoBRA study is a multicenter, prospective, observational study conducted in 36 sites in Brazil. NVAF patients ≥ 18 years treated with commercially available Edoxaban who initiated treatment for at least 14 days and no longer than 90 days prior to enrollment, and who are not simultaneously participating in any interventional study are eligible for this study. Seven hundred patients are planned to be enrolled and one-year of follow up, with data collections expected at baseline and 3, 6, and 12 months after the study enrollment. The primary safety objective is ISTH Clinically Relevant Bleeding, and the secondary effectiveness objective focuses on relevant cardiovascular outcomes related to NVAF.

Conclusion:

EdoBRA observational study will generate relevant additional information about NOAC Edoxaban on various aspects of patient management in routine care, such as its safety and effectiveness profile in patients with NVAF in Brazil.

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Research Letter

Cardiovascular Safety of Testosterone-Replacement Therapy: Critical Appraisal of a Currently Published Clinical Trial

Isabela Tramontini Muller et al. Sérgio Renato da Rosa Decker Regis Goulart Rosa Guilherme Rollin

Introduction

In the last edition on June 16 of the New England Journal of Medicine, A. Michael Lincoff et al. published a non-inferiority trial, entitled “Cardiovascular Safety of Testosterone-Replacement Therapy”, aiming to determine the safety outcomes of testosterone replacement therapy in middle-aged and older men with hypogonadism and pre-existing cardiovascular disease. The inclusion criteria for hypogonadism were symptoms and two fasting serum testosterone levels of less than 300 ng/dL in blood samples obtained between 5:00 a.m. and 11:00 a.m. The intervention was daily transdermal 1.62% testosterone gel with adjustments to maintain testosterone levels between 350 and 750 ng/dL or to respond to a hematocrit greater than 54%.

The baseline characteristics were men, with a mean age of 63 years, 80% were white, with a mean body-mass index of 35, and 55% had preexisting cardiovascular disease. The median testosterone level was 227 ng/dL in both groups, and the median increase from baseline was 148 ng/dL in the testosterone group, as compared to a median increase of 14 ng/dL in the placebo group. The study concluded non-inferiority for major adverse cardiac events (MACE) by comparing testosterone replacement to placebo, and a prespecified non-inferiority margin of 1.5. The final results showed a hazard ratio for the primary end-point of 0.96 (95% confidence interval, 0.78-1.17; p-value for non-inferiority <0.001). However, we have concerns regarding this claim of non-inferiority mainly because of two points: the margin of non-inferiority and the choice of a three-point MACE over a five-point MACE.^,

[…]

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Editorial

Images Complement Words: Absence of Progression of Myocardial and Coronary Artery Injury in School-Age Children Undergoing Radiofrequency Catheter Ablation

Jorge Elias Neto et al. Márcio Augusto Silva

Not even the biggest enthusiasts among cardiologists could predict, at the end of the 1980s, the impact that catheter ablation would have on the treatment of cardiac arrhythmias. Since its advent, evidence, and clinical experience have accumulated that allow to affirm its effectiveness in the treatment of the most varied forms of cardiac tachyarrhythmias in individuals of all age groups.^–

Particularly in the pediatric population, these perspectives have gradually shifted from the use of catheter ablation only in cases of drug-refractory arrhythmia to a first-line treatment and patient/parent preference.^,- However, this generalization raises the question of whether it is appropriate to adopt a technique into clinical practice in the absence of animal or human data that sufficiently demonstrates both its safety and efficacy in immature organs.^,

[…]

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Original Article

Myocardial Injury Progression after Radiofrequency Ablation in School-Age Children

Sissy Lara de Melo et al. Alberto Pereira Ferraz Stephanie Ondracek Lemouche Marcela Santana Devido … Gabriela Liberato de Sousa Carlos E. Rochitte Cristiano Faria Pisani Denise Tessariol Hachul Mauricio Scanavacca

Abstract

Background

The past decades have seen the rapid development of the invasive treatment of arrhythmias by catheter ablation procedures. Despite its safety and efficacy being well-established in adults, to date there has been little data in pediatric scenarios. One of the main concerns is the possible expansion of the ablation procedure scar in this population and its consequences over the years.

Objectives

This study aimed to analyze the risk of myocardial injury progression after radiofrequency catheter ablation in pediatric patients.

Methods

This is a retrospective study of 20 pediatric patients with previous ablation for treatment of supraventricular arrhythmia that underwent cardiac magnetic resonance and coronary angiography for evaluation of myocardial fibrosis and the integrity of the coronary arteries during follow-up.

Results

The median age at ablation procedure was 15.1 years (Q1 12.9, Q3 16.6) and 21 years (Q1 20, Q3 23) when the cardiac magnetic resonance was performed. Fourteen of them were women. Nodal reentry tachycardia and Wolf-Parkinson-White Syndrome were the main diagnosis (19 patients), with one patient with atrial tachycardia. Three patients had ventricular myocardial fibrosis, but with a volume < 0.6 cm ³ . None of them developed ventricular dysfunction and no patient had coronary lesions on angiography.

Conclusion

Radiofrequency catheter ablation did not show to increase the risk of myocardial injury progression or coronary artery lesions.

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ABCIC

Editorial

Contrast Echocardiography in Real Life: Practicality, Safety, and Cost-Effectiveness

Márcio Silva Miguel Lima

After approximately 2 decades of use in practice, based also on several clinical studies, it can be stated that ultrasound enhancing agents (UEA) are extremely safe, following recommendations for their preparation and administration.^– Severe adverse events are very rare, with an approximate prevalence of around 1 in every 10,000 administrations, anaphylactoid reactions being the most frequent.^,- Specifically with the contrast SonoVue® (sulfur hexafluoride) used in Brazil, Furtado, Rassi, et al., in their safety study, reported a very low incidence of only 0.6% of allergic reaction in their population of 1,099 patients who received this agent. In general, allergic reactions occur immediately or within 30 minutes after administration; they are of mild intensity and transitory. The most common presentation is the appearance of erythematous skin lesions and urticaria. In this scenario, however, special attention should be paid to respiratory signs and symptoms, such as dyspnea, laryngeal stridor, and bronchospasm, as well as signs and symptoms of progression to eventual circulatory collapse, such as dizziness, paleness, and hypotension, as these are warning signs for the onset of anaphylactic shock. Patients must be carefully evaluated and observed, and measures aimed at anaphylaxis should be promptly instituted with antihistamines, corticosteroids, and epinephrine, following the care protocol of the institution, whose personnel must be very well trained.

In October 2007, the United States Food and Drug Administration (FDA) issued a general contraindication (“black box”) for the use of Definity® and Optison® agents in acutely ill patients after analysis of 11 deaths potentially related to the use of these UEA. This restriction was later withdrawn after subsequent clinical studies provided extensive evidence of safety. Advanced pulmonary disease and pulmonary hypertension initially represented contraindications, but clinical trials confirmed their safety.^– Additionally, in relation to the suspicion or presence of significant intracardiac shunt, also a previous contraindication, it was suspended by the FDA in 2016.^, Currently, only history of allergic reaction to any component of UEA constitutes an absolute contraindication to their use.

[…]

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ABCIC

Original Article

Analyzing the Safety and Predictors of Arrhythmias during Dobutamine-Atropine Stress Echocardiography in a Non-Hospital Setting

Daniela do Carmo Rassi et al. Rogério Gomes Furtado Fabio de Paula Turco Luciano Henrique Melato … Ana Caroline Reinaldo de Oliveira Colandy Nunes Dourado Luiz Rassi Jr

Abstract

Background

Dobutamine-atropine stress echocardiography (DASE) is an accessible and important test, especially in patients under investigation for coronary artery disease. However, it is necessary to evaluate its safety, as it is used in patients with increasingly complex and serious conditions and in seniors.

Objective

To confirm the safety of DASE and evaluate the predictors of arrhythmias in a non-hospital setting.

Methods

DASE was performed to evaluate ischemia using the standard protocol of dobutamine infusion of 5 to 40 mcg/kg/min associated with atropine.

Results

From September to November 2010, 227 patients were evaluated prospectively. The mean age was 60.7 +/- 12.5 years old and 60.8% were females. Mean ejection fraction was 67.9 +/- 9. Among the adverse events, 12 patients presented hypertensive response, 466 had arrhythmia, 58 had headaches and 57 had precordial pain. No patient had acute myocardial infarction, ventricular fibrillation, cardiac rupture, asystole or death. As for the onset of significant arrhythmia, three patients had atrial fibrillation, 16 had sustained supraventricular tachycardia, 19 had non-sustained ventricular tachycardia and 2 had sustained ventricular tachycardia. In these patients, age (OR = 1.0559, p = 0.0002) and segmental contractility index at rest (SCIr) > 1 (OR 2.5039, p = 0.0354) were independent predictors for the onset significant arrhythmia during the test.

Conclusion

DASE was proven safe in this group of patients in a non-hospital setting. Age and SCIr > 1 were independent predictors for the onset of significant arrhythmia during the test. (Arq Bras Cardiol: Imagem cardiovasc. 2018;31(3):168-174)

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Original Article

Safety of SF6(SonoVue®) Contrast Agent on Pharmacological Stress Echocardiogram

Rogerio Gomes Furtado et al. Daniela do Carmo Rassi Luciano Henrique Melato Ana Caroline Reinaldo de Oliveira … Paula Meneses Nunes Priscila Elias Baccelli Sara Camila de Oliveira Santos Victor Emanuel Santos Luiz Rassi Junior Colandy Godoy Nunes

Abstract

Background

In 2007, the United States Food and Drug Administration mandated safety reviews of commercially available echocardiographic contrast agents (ECA), following reports of death. During the past years, different studies have proven the safety of ECA, but there have been few studies on SonoVue®.

Objectives

To evaluate the safety of SonoVue® during pharmacological stress echocardiography (PSE), by analyzing the incidence of allergic reactions and comparing groups regarding the appearance of arrhythmia, minor side effects and adverse events.

Methods

In this observational, prospective study, 2346 patients underwent PSE, and they were divided into the following 2 groups: group 1 with ECA (n = 1099) and group 2 without ECA (n = 1247). Patients were evaluated during PSE, at 24 hours, and at 30 days. Statistical significance was defined as p < 0.05.

Results

Group 1 had fewer minor side effects, such as headache (5/0.5% versus 19/1.5%, p = 0.012) and less reactive hypertension (3/0.3% versus 19/1.5%, p = 0.002); fewer arrhythmias, such as ventricular extrasystoles (180/16.4% versus 247/19.8%, p = 0.032) and paroxysmal supraventricular tachycardia (2/0.2% versus 15/1.2%, p = 0.003); and no adverse events, such as acute myocardial infarction (AMI) or death. In group 2, 1 patient had AMI in < 24 hours (1/01%), and there were 2 deaths in < 30 days (2/0.1%). SonoVue®-related urticaria was seen in 3 (0.3%) patients, without anaphylactic reaction.

Conclusion

SonoVue® demonstrated safety during PSE. No cases of death, AMI, or anaphylactic reaction were observed. There was a lower incidence of minor side effects and arrhythmias in the group that received ECA, as well as a low incidence of mild allergic reactions.

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IJCS

Original Article

Early Use of Handgrip Exercise Associated with Dobutamine Stress Echocardiography in Women

Isabela de Andrade Lindner et al. Patricia Sens de Oliveira Caroline de Oliveira Fischer Bacca Josie Budag Matsuda … Franciani Rodrigues da Rocha Jeancarlo Visentainer Luiz Eduardo Bacca

Abstract

Background

Coronary artery disease (CAD) is an important cause of morbidity and mortality in women and requires early diagnosis for defining the appropriate treatment.

Objective

To identify the positive predictive value (PPV) and safety of the early use of handgrip exercise in pharmacological stress echocardiography using dobutamine (early-ECHO) in women.

Methods

Positive ischemic early-ECHO records from 111 women were evaluated from January 2012 to March 2018. Subsequently, the hospital medical records were verified to locate patients who underwent conventional coronary angiography (CCA), and we analyzed the medical conduct adopted for these patients. Statistical analyses were performed using SPSS employing one-way analysis of variance (ANOVA), Fisher’s exact test, or Pearson’s chi-square test. The level of statistical significance was set at p < 0.05 for all analyses.

Results

Four patients (4.4%) presented serious complications during the examination. Out of 90 patients who underwent CCA, 71 (78.9%) had CAD. Among these 71 patients, 58 (81.7%) had severe lesions and 13 (18.3%) presented moderate CAD. Moreover, CCA did not demonstrate relevant coronary lesions in 19 of the 90 patients (21.1%). Among patients with severe CAD, 16 (27.6%) underwent myocardial revascularization surgery; 34 (58.6%) underwent percutaneous coronary angioplasty; and 08 (13.7%) had their clinical treatments intensified. The PPV for early-ECHO was 78.9%.

Conclusions

Early-ECHO showed a high PPV for diagnosing myocardial ischemia in women. It presented a low complication rate and provided rapid disease identification, allowing the early treatment of injuries and potentially preventing CAD complications.

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Original Article

Catheter Ablation for Treatment of Atrial Fibrillation and Supraventricular Arrhythmias Without Fluoroscopy Use: Acute Efficacy and Safety

Eduardo B. Saad et al. Charles Slater Luiz Antonio Oliveira Inácio Jr Gustavo Vignoli dos Santos … Lucas Carvalho Dias Luiz Eduardo Montenegro Camanho

Abstract

Background

The use of ionizing radiation in medical procedures is associated with significant health risks for patients and the health care team.

Objectives

Evaluate the safety and acute efficacy of ablation for atrial fibrillation (AF) and supraventricular arrhythmias (SVTs) using an exclusively non-fluoroscopic approach guided by intracardiac echo (ICE) and 3D-mapping.

Methods

95 pts (mean age 60 ± 18 years, 61% male) scheduled for AF Ablation (69 pts, 45 paroxysmal AF and 24 persistent AF) or non-AF SVT (26 pts – 14 AV node reentry, 6 WPW, 5 right atrial (RA) flutters, 1 atrial tachycardia) underwent zero fluoro procedures. Nine patients (9.5%) had permanent pacemakers or defibrillator resynchronization (CRT-D) devices. Both CARTO (65%) and NAVx (35%) mapping systems were used, as well as Acunav and ViewFlex ICE catheters.

Results

Pulmonary vein isolation (PVI), as well as all other targets that needed ablation in both atria were reached and adequately visualized. No pericardial effusions, thrombotic complications or other difficulties were seen in these series. Difficult transseptal puncture (19 patients – 20%) was managed without fluoroscopy in all cases. No backup fluoroscopy was used, and no lead apparel was needed. Pacemaker interrogations after the procedure did not show any lead damage, dislocation, or threshold changes.

Conclusions

A radiation-free (fluoroless) catheter ablation strategy for AF and other atrial arrhythmias is acutely safe and effective when guided by adequate ICE and 3D-mapping utilization. Multiple different bi-atrial sites were reached and adequately ablated without the need for backup fluoroscopy. No complications were seen. (Arq Bras Cardiol. 2020; 114(6):1015-1026)

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Editorial

Catheter Ablation Without Use of X-rays to Treat Atrial Fibrillation and Atrial Arrhythmia

Leandro Ioschpe Zimerman

Radiofrequency ablation is a well-established method and is increasingly used in the treatment of tachyarrhythmia. Traditionally, it is done by placing fluoroscopy-guided intracavitary catheters. Over the years, however, a number of problems related to exposure to radiation have become more evident, such as cataracts, genetic mutations, cancer. It is not by chance that the number of tumors in the left cerebral hemisphere, which receives the greatest amount of radiation, is greater than in the right hemisphere, in interventionists. It is important to remember that the risk of cancer is linear with exposure, without a defined threshold, and that there is a cumulative effect. In longer procedures, even severe skin lesions can develop in patients. To reduce these risks to patients and the medical staff, several actions were taken: fluoroscopic devices and methods with less radiation, personal protective equipment, such as an apron, thyroid protection, goggles, cap and even leaded gloves. Protection increased, but at the expense of orthopedic problems due to the weight that was carried, in so many procedures, for so long. New solutions were created, such as suspended lead aprons. But along with this increase in personal protection, the idea of effectively performing the procedure with the least amount of radiation possible gained momentum. For this, the development of three-dimensional mapping systems was the driving force required. This, associated with the use of ablation catheters by contact, made it possible to perform procedures, including complex ones, manipulating catheters and applying energy efficiently and safely, without requiring fluoroscopic imaging. In less complex procedures, especially on the right side of the heart, ablations without fluoroscopy were described.^, In pregnant women, it has become a feasible solution. Even for the more complex procedures, “near-zero” fluoroscopy was recommended. “Near-zero” because it was still necessary to use fluoroscopy at times, such as transseptal puncture, for example.

At the same time, ultrasound has been increasingly used in invasive cardiac procedures and, more specifically, in electrophysiology. Vascular ultrasound is used to support vascular punctures and to reduce AV fistulas and pseudoaneurysms. Transesophageal echo is useful to rule out atrial appendage thrombus and to assist transseptal puncture. Even more useful is intracardiac echo, which assists transseptal puncture, shows pulmonary vein ostia, rules out pericardial effusion, shows recesses during cavotricuspid isthmus ablation and confirms adequate catheter contact.

[…]

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IJCS

Viewpoint

Covid-19 and Safety in the Cath Lab: Where We Are and Where We Are Headed

Giordana Zeferino Mariano et al. Viviana Guzzo Lemke Maria Sanali Moura Paiva Gláucia Maria Moraes de Oliveira

Safety measures in the procedure preparation stage

A study conducted in China with 72,314 patients with COVID-19 (44,672 laboratory-confirmed cases, 16,186 suspected cases, and 10,567 clinically diagnosed cases) has reported fever, cough, dyspnea, myalgia, fatigue and diarrhea as the most common symptoms. Other signs and symptoms have been reported, such as sore throat, chest pain, mental confusion, and lethargy. The authors have highlighted that COVID-19 had a benign course in 80% of the cases, and that many patients, although asymptomatic, could carry the virus. It is worth noting the importance of the differential diagnosis of dyspnea and fatigue, especially when associated with the other symptoms.

During a respiratory pandemic, patients and their families should be informed about the risks of contamination, despite all additional measures taken to minimize them. Because the number of elective procedures will be drastically reduced during that period, the length of hospital stay is predicted to be the minimum necessary for each protocol consensually elaborated. Moreover, defining a procedure as elective requires clinical judgement, because postponing it might have effects that will increase the likelihood of decompensation and adverse events during the pandemic, such as in high-risk patients with unstable angina. Therefore, the decision about performing a procedure should be individualized and based on the patient’s risk and benefit analysis.

[…]

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IJCS

Original Article

A Retrospective Study on Unfractionated Bovine Heparin Safety in On-Pump Cardiac Surgery

Fernando Antonio de Lima Torres et al. Andressa C. B Torres Allinson Ribeiro Cauê O Maia … Fernanda P Almeida João Roceto Jorge A Matkovski Matheus G Kovalski Vanessa A Pizato Tatiana M. G Cordeiro

Abstract

Background:

Heparin decreases the risks of thrombotic phenomena in extracorporeal circulation. However, it must present a robust safety profile itself, especially for bleeding. Contamination of porcine heparin demands an alternative source and consequent assessment of safety.

Objective:

To evaluate the safety of unfractionated bovine heparin during on-pump cardiac surgery.

Methods:

Descriptive, retrospective study, evaluating medical records from all patients who had on-pump cardiac surgery over four years. We observed the occurrence of bleeding, thrombocytopenia, postoperative vasoplegia, activated clotting time values and any other coagulation phenomena as safety profile parameters.

Results:

We evaluated 204 medical records reporting the use of unfractionated bovine heparin. 66.18% of the patients presented thrombocytopenia, 1.04% presented bleeding of more than 2000 mL in the first 24 hours of the postoperative period. One patient presented clots in the surgical field. Median activated clotting time was 137 seconds at baseline, 803 seconds after the first dose of heparin and, after protamine, it returns to similar baseline values, that is, 149.5 seconds.

Conclusion:

Unfractionated bovine heparin did not present unusual adverse effects and can be considered safe for on-pump cardiac surgery.

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Original Article

Low Prevalance of Major Events Adverse to Exercise Stress Echocardiography

Stephanie Macedo Andrade et al. Caio José Coutinho Leal Telino Antônio Carlos Sobral Sousa Enaldo Vieira de Melo … Carla Carolina Cardoso Teixeira Clarissa Karine Cardoso Teixeira Jaquiele Santos Santana Igor Larchert Mota Carlos José Oliveira de Matos Joselina Luzia Menezes Oliveira

Abstract

Background:

Stress echocardiography is well validated for diagnosis and risk stratification of coronary artery disease. Exercise stress echocardiography (ESE) has been shown to be the most physiological among the modalities of stress, but its safety is not well established.

Objective:

To study the complications related to ESE and clinical and echocardiographic variables most commonly associated with their occurrence.

Methods:

Cross-sectional study consisting of 10250 patients submitted to ESE for convenience, from January 2000 to June 2014. Cardiac Arrhythmias (CA) were the most frequent complications observed during the examination. The volunteers were divided into two groups according to the occurrence of CA during ESE: G1 group, composed of patients who have CA, and G2 formed by individuals who did not show such complication. Results: Group G1, consisting of 2843 patients (27.7%), and Group G2 consisting of 7407 patients (72.3%). There was no death, acute myocardial infarction, ventricular fibrillation or asystole. Predominant CAs were: supraventricular extrasystoles (13.7%), and ventricular extrasystoles (11.5%). G1 group had a higher mean age, higher frequency of hypertension and smoking, larger aortic roots and left atrium (LA) and lower ejection fraction than G2. G1 group also had more ischemic changes (p < 0.001). The predictor variables were age (RR 1.04; [CI] 95% from 1.038 to 1.049) and LA (RR 1.64; [CI] 95% from 1.448 to 1.872).

Conclusion:

ESE proved to be a safe modality of stress, with non-fatal complications only. Advanced age and enlargement of the left atrium are predictive of cardiac arrhythmias.

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Letter to the Editor

Safety of the cardiopulmonary 6-minute walk test

Guilherme Veiga Guimarães et al. Vitor Oliveira Carvalho Juliana Fernanda Belli

LETTER TO THE EDITOR

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Artigo Original

Effectiveness and safety of drug-eluting stents in a cardiology clinic in Curitiba, PR, Brazil

Chiu Yun Yu Braga et al. Luiz Antonio Rivetti Francisco de Paula Stella

BACKGROUND: The effectiveness and safety of drug-eluting stents (DES) have still been questioned. OBJECTIVE: The objective of this study was to evaluate the effectiveness and safety of these stents, as well as the incidence of target lesion revascularization (TLR), in addition to identifying possible variables influencing the need for TLR. METHODS: A total of 203 patients from Hospital Costantini who were clinically followed up for one to 3 years were selected. RESULTS: The sample characteristics were as follows: 470 lesions; 171 (84.24%) male patients; 54 (26.6%) had diabetes; 131 (64.35%) had hypertension; 127 (62.56%), dyslipidemia; 40 (19.70%) were smokers; and 79 (38.92%) had a family history of coronary artery disease. Also: 49 (24.14%) patients presented with stable angina; 58 (28.57%), unstable angina; and 6 (2.96%), myocardial infarction. Eighty five (41.87%) patients were asymptomatic, and 146 (71.92%), had multivessel disease. As for the characteristics of the lesions, 77.45% were B2/C (AHA/ACC). Taxus was implanted in 73.62% of the patients. Stents with diameter > 2.5 mm were used in 381 (81.96%) patients. The stent length was < 30 mm in 67.87% of the lesions, with a mean of 2.3 stents per patient. After follow-up, 19 patients (9.3%) underwent TLR. Four patients died (1.97%), two of them of MI (0.98%), one of stroke (0.49%), and one of abdominal aneurysm (0.49%). Also, one patient died of late thrombosis (0.49%), and one of reinfarction (0.49%). In the statistical analysis carried out, only the bifurcation lesions variable reached values close to the statistical significance level, with p < 0.06. CONCLUSION: In conclusion, drug-eluting stents have good effectiveness and safety profiles; the incidence of TLR was 9.3%, and we did not identify a variable correlated with the need for TLR.

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Artigo Original

Safety of transesophageal echocardiography in adults: study in a multidisciplinary hospital

Alexandre Ferreira Cury et al. Marcelo Luiz Campos Vieira Claudio Henrique Fischer Ana Clara Tude Rodrigues … Adriana Cordovil Claudia Monaco Gustavo Alberto Naccarato Glaucia Tavares Edgar Bezerra Lira Filho Laise Antonia Guimarães Samira Saady Morhy

BACKGROUND: TEE is a semi-invasive tool broadly used and its utilization associated to sedatives drugs might to affect the procedure safety. OBJECTIVE: to analyze aspects of TEE safety associated to the use of Midazolan (MZ) and Flumazenil (FL) and the influence of the clinical variables on the event rate. METHOD: prospective study with 137 patients that underwent TEE with MZ associated to moderate sedation. We analyzed the following events: complications related with the topical anesthesia, with MZ use and with the procedure. Uni- and multivariate analyses were used to test the influence of the clinical variables: age, sex, stroke, myocardiopathy (MP), duration of the test, mitral regurgitation (MR) and the MZ dose. RESULTS: All patients (65±16 yrs; 58% males) finished the examination. The mean doses of MZ and FL were 4.3±1.9 mg and 0.28±0.2 mg, respectively. The duration of the examination and the mean ejection fraction (EF) were 16.4±6.1 minutes and 60±9%, respectively. Mild hypoxia (SO2<90%) was the most common event (11 patients); 3 patients (2%) presented transient hypoxia due to upper airway obstruction by probe introduction and 8 (5.8%) due to hypoxia caused by MZ use. Transient hypotension (SAP<90mmHg) occurred in 1 patient (0.7%). The multivariate analysis showed that severe MR, MP (EF5mg) were associated with events (p<0.001). The EF was 40%, in the group with MP and 44% in the group with severe MR and it can be a factor associated with clinical events in the last group. CONCLUSION: TEE with sedation presents a low rate of events. There were no severe events and there was no need to interrupt the examinations.

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Editorial

Transesophageal echocardiography: how safe is it?

Márcia de Melo Barbosa

EDITORIAL

Transesophageal echocardiography: how safe is it?

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Artigo de Pesquisa

Special recommendations for lipid-lowering treatment: efficacy and safety

Tania Leme da Rocha Martinez et al. Helena Maria do Nascimento

Pharmacologic lipid-lowering interventions should be monitored periodically to assess efficacy and safety parameters. Statins are usually well-tolerated drugs and major side effects include increased serum liver and muscle enzymes (AST, ALT, CK). Treatment should be stopped or diminished in case of significant increase of AST or ALT (> 3x ULN), or CK (> 10x ULN). Other lipid lowering agents may also produce hepatotoxicity or myositis, especially in association with statins (fibrates and nicotinic acid) or in presence of metabolic abnormalities (thyroid, liver or renal disorders). Nicotinic acid can also increase glucose and uric acid plasma levels. Laboratory tests might be performed prior to hypolipidemic drug treatment and should be repeated every three months during the first year and then at 6-mo intervals. Shorter intervals should be recommended in individual cases.

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