Randomized Study Comparing Radiofrequency Ablation with the PVAC Gold System vs. Antiarrhythmic Drugs in Elderly Patients with Symptomatic Atrial Fibrillation. / Estudo Randomizado Comparando a Ablação por Cateter com o PVAC Gold vs. Tratamento com Fármacos Antiarrítmicos em Pacientes Idosos com Fibrilação Atrial Sintomática.

BACKGROUND: There are no randomized studies comparing the maintenance of sinus rhythm after catheter ablation (CA) concerning treatment with antiarrhythmic drugs (AA) in elderly patients with paroxysmal atrial fibrillation (AF). OBJECTIVES: To compare the clinical results of pulmonary vein (PV) isolation with the second-generation PVAC Gold catheter against AA treatment in elderly people with recurrent symptomatic paroxysmal AF, refractory to at least one AA, and without structural heart disease. METHODS: Sixty patients with paroxysmal AF ≥ 65 years old were randomized to two forms of treatment: group 1: CA and group 2: AA drugs. The primary outcome was the AF recurrence-free rate after at least one year of follow-up. Secondary outcomes were: progression to persistent forms of AF, impact on quality of life (QOLF), and complications. The significance level adopted in the statistical analysis was 5% (p<0.05). RESULTS: The AF recurrence-free rate was 80% (10% with amiodarone) in the CA group, after 1.3 procedures per patient and 65% in the AA group (60% with amiodarone), (p = 0.119) in an average follow-up of 719 days (Q1: 566; Q3: 730). The persistent AF free rate was 83.4% in the AC group and 67.7% in the AA group (p = 0.073) Both strategies showed an improvement in the AFQoL score during follow-up (p < 0.001), with no difference between the groups. Although without clinical repercussions or impact on the intellectual assessment test, 25% of patients in the CA group showed signs of cerebral embolization on brain MRI. CONCLUSIONS: Both strategies for maintaining sinus rhythm promoted an improvement in the quality of life of elderly patients with symptomatic AF, with no statistical difference in the clinical outcomes. Additional studies using technologies with a better safety profile are needed to evaluate the benefits of CA in elderly patients with AF.

FUNDAMENTO: Não existem estudos randomizados comparando a manutenção do ritmo sinusal após ablação por cateter (AC) em relação ao tratamento com fármacos antiarrítmicos (AA) em pacientes idosos portadores fibrilação atrial (FA) paroxística. OBJETIVOS: Comparar os resultados clínicos do isolamento das veias pulmonares (VPs) com o cateter PVAC Gold de segunda geração com o uso de AA em idosos com FA paroxística sintomática, recorrente, apesar do uso de fármacos AA. MÉTODOS: Sessenta pacientes com FA paroxística ≥ 65 anos e sem cardiopatias estruturais foram randomizados para duas formas de tratamento: grupo 1: AC e grupo 2: AA. O desfecho primário foi a taxa livre de recorrência de FA após pelo menos um ano de seguimento. Os desfechos secundários foram: progressão para formas persistentes de FA, impacto na qualidade de vida (QVFA) e complicações. O nível de significância adotado na análise estatística foi de 5% (p<0,05). RESULTADOS: A taxa livre de recorrência de FA foi de 80% (10% com amiodarona) no grupo AC, após 1,3 procedimentos por paciente e de 65% no grupo AA (60% com amiodarona), (p = 0,119) num seguimento médio de 719 dias (Q1: 566; Q3: 730). A taxa livre de FA persistente foi de 83,4% no grupo AC e de 67,7% no grupo AA (p = 0,073). Ambas as estratégias apresentaram melhora no escore de QVFA durante o seguimento (p < 0,001), sem diferença entre os grupos. Embora sem repercussão clínica ou impacto no teste de avaliação intelectual, 25% dos pacientes do grupo PVAC apresentou sinais de embolização cerebral na RNM cerebral. CONCLUSÕES: Ambas as estratégias para manutenção do ritmo sinusal promoveram melhora na qualidade de vida de pacientes idosos com FA sintomática, sem diferença estatística nos desfechos clínicos preconizados. Estudos adicionais usando tecnologias com melhor perfil de segurança são necessários para avaliar os benefícios da AC em pacientes idosos com FA.

Estudo Randomizado Comparando a Ablação por Cateter com o PVAC Gold vs. Tratamento com Fármacos Antiarrítmicos em Pacientes Idosos com Fibrilação Atrial Sintomática / Randomized Study Comparing Radiofrequency Ablation with the PVAC Gold System vs. Antiarrhythmic Drugs in Elderly Patients with Symptomatic Atrial Fibrillation

Resumo Fundamento Não existem estudos randomizados comparando a manutenção do ritmo sinusal após ablação por cateter (AC) em relação ao tratamento com fármacos antiarrítmicos (AA) em pacientes idosos portadores fibrilação atrial (FA) paroxística. Objetivos Comparar os resultados clínicos do isolamento das veias pulmonares (VPs) com o cateter PVAC Gold de segunda geração com o uso de AA em idosos com FA paroxística sintomática, recorrente, apesar do uso de fármacos AA. Métodos Sessenta pacientes com FA paroxística ≥ 65 anos e sem cardiopatias estruturais foram randomizados para duas formas de tratamento: grupo 1: AC e grupo 2: AA. O desfecho primário foi a taxa livre de recorrência de FA após pelo menos um ano de seguimento. Os desfechos secundários foram: progressão para formas persistentes de FA, impacto na qualidade de vida (QVFA) e complicações. O nível de significância adotado na análise estatística foi de 5% (p<0,05). Resultados A taxa livre de recorrência de FA foi de 80% (10% com amiodarona) no grupo AC, após 1,3 procedimentos por paciente e de 65% no grupo AA (60% com amiodarona), (p = 0,119) num seguimento médio de 719 dias (Q1: 566; Q3: 730). A taxa livre de FA persistente foi de 83,4% no grupo AC e de 67,7% no grupo AA (p = 0,073). Ambas as estratégias apresentaram melhora no escore de QVFA durante o seguimento (p < 0,001), sem diferença entre os grupos. Embora sem repercussão clínica ou impacto no teste de avaliação intelectual, 25% dos pacientes do grupo PVAC apresentou sinais de embolização cerebral na RNM cerebral. Conclusões Ambas as estratégias para manutenção do ritmo sinusal promoveram melhora na qualidade de vida de pacientes idosos com FA sintomática, sem diferença estatística nos desfechos clínicos preconizados. Estudos adicionais usando tecnologias com melhor perfil de segurança são necessários para avaliar os benefícios da AC em pacientes idosos com FA.

Abstract Background There are no randomized studies comparing the maintenance of sinus rhythm after catheter ablation (CA) concerning treatment with antiarrhythmic drugs (AA) in elderly patients with paroxysmal atrial fibrillation (AF). Objectives To compare the clinical results of pulmonary vein (PV) isolation with the second-generation PVAC Gold catheter against AA treatment in elderly people with recurrent symptomatic paroxysmal AF, refractory to at least one AA, and without structural heart disease. Methods Sixty patients with paroxysmal AF ≥ 65 years old were randomized to two forms of treatment: group 1: CA and group 2: AA drugs. The primary outcome was the AF recurrence-free rate after at least one year of follow-up. Secondary outcomes were: progression to persistent forms of AF, impact on quality of life (QOLF), and complications. The significance level adopted in the statistical analysis was 5% (p<0.05). Results The AF recurrence-free rate was 80% (10% with amiodarone) in the CA group, after 1.3 procedures per patient and 65% in the AA group (60% with amiodarone), (p = 0.119) in an average follow-up of 719 days (Q1: 566; Q3: 730). The persistent AF free rate was 83.4% in the AC group and 67.7% in the AA group (p = 0.073) Both strategies showed an improvement in the AFQoL score during follow-up (p < 0.001), with no difference between the groups. Although without clinical repercussions or impact on the intellectual assessment test, 25% of patients in the CA group showed signs of cerebral embolization on brain MRI. Conclusions Both strategies for maintaining sinus rhythm promoted an improvement in the quality of life of elderly patients with symptomatic AF, with no statistical difference in the clinical outcomes. Additional studies using technologies with a better safety profile are needed to evaluate the benefits of CA in elderly patients with AF.

Evaluation of a new treadmill exercise protocol to unmask type 1 Brugada electrocardiographic pattern: can we improve diagnostic yield?

AIMS: High precordial leads (HPL) on the resting electrocardiogram (ECG) are widely used to improve diagnostic detection of type 1 Brugada ECG pattern (Br1ECGp). A parasympathetic activation marks the initial recovery phase of treadmill stress testing (TET), and this can be useful for detecting the typical ECG pattern. Our study aimed to evaluate the role of a new HPL-treadmill exercise testing (TET) protocol in detecting Br1ECGp fluctuation compared to resting HPL-ECG. METHODS AND RESULTS: 74 out of 163 patients of a Brugada syndrome (BrS) Brazilian cohort (GenBra Registry) underwent exercise testing with HPL-TET protocol. Precordial leads were displayed in strategic positions in the right and left parasternal spaces. The step-by-step analysis included ECG classification (as presence or absence of Br1ECGp) in standard vs. HPL leads placement in the following sequences: resting phase, maximal exercise, and the passive recovery phase (including 'quick lay down'). For heart rate recovery (HRR) measurements and comparisons, a Student's t-test was applied. McNemar tests compared the detection of Br1ECGp. The significance level was defined as P < 0.05. Fifty-seven patients (57/74; 77%) were male, the mean age was 49.0 ± 14, 78.4% had spontaneous BrS, and the mean Shanghai score was 4.5. The HPL-TET protocol increased Br1ECGp detection by 32.4% against resting HPL-ECG (52.7% vs. 20.3%, P = 0.001) alone. CONCLUSION: Stress testing using HPL with the passive recovery phase in the supine position offers an opportunity to unmask the type 1 Br1ECGp, which could increase the diagnostic yield in this population.

Low rate of life-threatening events and limitations in predicting invasive and noninvasive markers of symptoms in a cohort of type 1 Brugada syndrome patients: Data and insights from the GenBra registry.

BACKGROUND: Brugada syndrome (BrS) has diagnostic challenges and controversial risk assessment. We aimed to investigate invasive and noninvasive parameters in symptomatic and asymptomatic patients from a Brazilian cohort of type-1 BrS. METHODS: Patients with spontaneous and drug-induced type-1 BrS were classified into two groups, asymptomatic (n = 116, 84.1%) and symptomatic (n = 22, 15.9%; 13 with arrhythmogenic syncope, 9 with aborted sudden cardiac death). Genetic testing, EPS parameters, and electrocardiogram (ECG) parameters were analyzed. RESULTS: A total of 138 consecutive patients were eligible, 101 men (73.2%), mean 41.4 years, mostly probands (79%). Spontaneous pattern, observed in 77.5% of the patients, was associated with symptoms only if expressed in V1 and V2 standard position (not high precordial leads; p = .014). All symptomatic patients were probands. The presence of right ventricular outflow tract conduction delay (RVOTcd) signs, positive EPS, and SCN5A status was similar between symptomatic and asymptomatic subjects. During the mean 75-month follow-up, eight patients had appropriate therapies. All had spontaneous type-1 ECG pattern and 2/8 (25%) were asymptomatic, with positive EPS. The overall LAE incidence of 1.1% per year dropped to 0.27% in asymptomatic patients. RVOTcd occurred more frequently in SCN5A carriers (QRS-f 33.3% vs. 7.7%; p = .005, AVR sign 58.3% vs. 13.6%; p < .001; deep S in lead I 75% vs. 48.5%, p = .025%), as well as longer HV interval (66 vs. 49 ms; p < .001). CONCLUSIONS: Spontaneous type-1 Brugada pattern in standard leads and proband status were more frequent in symptomatic subjects. RVOTcd, more common in SCN5A carriers, did not predict symptoms in BrS patients. EPS exhibited limited prognostic value for this low-risk population.

Catheter ablation of the parahisian accessory pathways from the aortic cusps-Experience of 20 cases-Improving the mapping strategy for better results.

INTRODUCTION: Catheter ablation of the parahisian accessory pathways (PHAP) has been established as the definitive therapy for this type of arrhythmia. However, the PHAP proximity to the normal atrioventricular conduction system makes the procedure technically challenging. Here, we have reported a case series of 20 patients with PHAP who underwent aortic access ablation to evaluate the safety and efficacy of this approach in the PHAP ablation. METHODS AND RESULTS: The ablation through the aortic cusps was the successful approach in 13 of 20 (65%) of the cases. In 11 patients, the aortic approach was the initial strategy for ablation, and the accessory pathway was eliminated in seven (63.6%) of them. The aortic approach followed a failed right-sided attempt in nine patients. In six (66.7%) patients, the ablation was successful with the aortic approach. The only independent predictor for the successful ablation with each approach was the earliest ventricular activation before delta wave (predelta time) and a right-sided earliest ventricular activation of more than 23 ms had high sensitivity and specificity for right-sided success. Systematically using the two strategies (right and left approaches), the ablation of the PHAP was successful in 18 (90%) patients. CONCLUSION: The aortic approach seems to be a safe and effective strategy for the ablation of PHAP. It can be used when the right-sided approach fails or even considered as an initial strategy when the predelta time is less than 23 ms in the right septal region. When combining the right- and left-sided approaches, the success rate is high. We believe that the retrograde aortic approach remains a key tool for this challenging ablation.

Comparative study of strategies to prevent esophageal and periesophageal injury during atrial fibrillation ablation.

OBJECTIVE: To compare the prevalence of esophageal and periesophageal thermal injury in patients undergoing radiofrequency (RF) atrial fibrillation (AF) ablation using 8 mm tip catheters during three different esophageal protection strategies. METHODS: Forty-five consecutive patients with paroxysmal or persistent AF underwent first ablation procedure, besides esophagogastroduodenoscopy (EGD) combined with radial endosonography (EUS) performed before and after the pulmonary vein (PV) isolation. Before the procedure, patients were randomly assigned to one of three esophageal lesion protection strategies: group I-without any protective or monitoring dispositive and limiting RF applications to 30 W for 20 seconds, in left atrium posterior wall (LAPW); group II-power and time of RF delivery, up to 50 W for 20 seconds at LAPW, limited by esophageal temperature monitoring; group III-applications of RF in LAPW with fixed power application of 50 W for 20 seconds during continuous esophageal cooling. RESULTS: Baseline characteristics of patients were similar in all groups. The four PVs were isolated in 14 (93.3%), 13 (86.7%), and 15 (100%) patients, respectively in groups I, II, and III. The mean RF power was significantly higher (P < .001) in the posterior side of PVs in group III. Post-AF ablation EGD and EUS revealed two esophageal wall ulcerations and two periesophageal mediastinal edemas only in the esophageal cooling group (P = .008). CONCLUSION: Esophageal cooling balloon strategy resulted in a higher RF power energy delivery when ablating at the LA posterior wall, using 8 mm nonirrigated tip catheters under temperature mode control. Despite that, patients presented a relatively low incidence of esophageal and periesophaeal injuries.

Carotid Sinus Massage in Syncope Evaluation: A Nonspecific and Dubious Diagnostic Method.

BACKGROUND: Carotid sinus hypersensitivity (CSH) is a frequent finding in the evaluation of syncope. However, its significance in the clinical setting is still dubious. A new criterion was proposed by Solari et al. with a symptomatic systolic blood pressure (SBP) cut-off value of ≤ 85 mmHg to refine the vasodepressor (VD) response diagnosis. OBJECTIVE: To determine and compare the response to carotid sinus massage (CSM) in patients with and without syncope according to standard and proposed criteria. METHODS: CSM was performed in 99 patients with and 66 patients without syncope. CSH was defined as cardioinhibitory (CI) for asystole ≥ 3 seconds, or as VD for SBP decrease ≥ 50 mmHg. RESULTS: No differences in the hemodynamic responses were observed during CSM between the groups, with 24.2% and 25.8% CI, and 8.1% and 13.6% VD in the symptomatic and asymptomatic groups, respectively (p = 0.466). A p value < 0.050 was considered statistically significant. During the maneuvers, 45 (45.45%) and 34 (51.5%) patients in the symptomatic and asymptomatic groups achieved SBP below ≤ 85 mmHg. Symptoms were reported especially in those patients in whom CSM caused a SBP decrease to below 90 mmHg and/or asystole > 2.5 seconds, regardless of the pattern of response or the presence of previous syncope. CONCLUSION: The response to CSM in patients with and without syncope was similar; therefore, CSH may be an unspecific condition. Clinical correlation and other methods of evaluation, such as long-lasting ECG monitoring, may be necessary to confirm CSH as the cause of syncope.

Carotid Sinus Massage in Syncope Evaluation: A Nonspecific and Dubious Diagnostic Method / Massagem do Seio Carotídeo na Avaliação da Síncope: Um Método Diagnóstico Inespecífico e Duvidoso

Abstract Background: Carotid sinus hypersensitivity (CSH) is a frequent finding in the evaluation of syncope. However, its significance in the clinical setting is still dubious. A new criterion was proposed by Solari et al. with a symptomatic systolic blood pressure (SBP) cut-off value of ≤ 85 mmHg to refine the vasodepressor (VD) response diagnosis. Objective: To determine and compare the response to carotid sinus massage (CSM) in patients with and without syncope according to standard and proposed criteria. Methods: CSM was performed in 99 patients with and 66 patients without syncope. CSH was defined as cardioinhibitory (CI) for asystole ≥ 3 seconds, or as VD for SBP decrease ≥ 50 mmHg. Results: No differences in the hemodynamic responses were observed during CSM between the groups, with 24.2% and 25.8% CI, and 8.1% and 13.6% VD in the symptomatic and asymptomatic groups, respectively (p = 0.466). A p value < 0.050 was considered statistically significant. During the maneuvers, 45 (45.45%) and 34 (51.5%) patients in the symptomatic and asymptomatic groups achieved SBP below ≤ 85 mmHg. Symptoms were reported especially in those patients in whom CSM caused a SBP decrease to below 90 mmHg and/or asystole > 2.5 seconds, regardless of the pattern of response or the presence of previous syncope. Conclusion: The response to CSM in patients with and without syncope was similar; therefore, CSH may be an unspecific condition. Clinical correlation and other methods of evaluation, such as long-lasting ECG monitoring, may be necessary to confirm CSH as the cause of syncope.

Resumo Fundamento: A hipersensibilidade do seio carotídeo (HSC) é um achado frequente na avaliação da síncope. Entretanto, o valor da resposta positiva é ainda incerto no contexto clínico. Novo critério diagnóstico para tentar refinar a resposta vasodepressora (VD) foi proposto por Solari et al. com determinação da queda sintomática da pressão arterial sistólica (PAS) a níveis ≤ 85 mmHg como ponto de corte. Objetivo: Determinar e comparar a resposta à massagem do seio carotídeo (MSC) em pacientes com e sem síncope de acordo com os critérios vigentes e propostos. Métodos: A MSC foi realizada em 99 pacientes com síncope e 66 pacientes sem síncope. A HSC foi definida como cardioinibitória (CI), se assistolia ≥ 3 segundos, ou VD, se queda da PAS ≥ 50 mmHg. Resultados: Não foram observadas diferenças na resposta hemodinâmica entre os grupos durante a MSC, com 24,2% e 25,8% de resposta CI, e 8,1% e 13,6% de resposta VD nos grupos sintomático e assintomático, respectivamente (p = 0,466). Considerou-se p < 0,05 estatisticamente significativo. Durante as manobras, 45 (45,45%) e 34 (51,5%) pacientes nos grupos sintomático e assintomático atingiram PAS ≤ 85 mmHg. Sintomas foram relatados principalmente por pacientes em que a MSC reduziu a PAS para menos de 90 mmHg e/ou causou assistolia > 2,5 segundos, independentemente do padrão da resposta ou história de síncope prévia. Conclusão: As respostas à MSC em pacientes com e sem síncope foram semelhantes. Portanto, a HSC pode ser uma condição inespecífica. A correlação clínica mais precisa e outros métodos para avaliação, como monitoramento por ECG de longa duração, podem ser necessários para confirmação da HSC como causa da síncope.

The morphology of the coronary sinus in patients with congenitally corrected transposition: implications for cardiac catheterisation and re-synchronisation therapy.

Patients with congenitally corrected transposition frequently benefit from re-synchronisation therapy or ablation procedures. This is likely to require catheterisation of the coronary sinus. Its anatomy, however, is not always appreciated, despite being well-described. With this caveat in mind, we have evaluated its location and structure in hearts with congenitally corrected transposition in order to reinforce the guidance needed by the cardiac interventionist. We dissected and inspected the coronary sinus, the oblique vein of the left atrium, and the left-sided-circumflex venous channel in eight heart specimens with corrected transposition and eight controls, measuring the orifice and length of the sinus and the atrioventricular valves. In two-thirds of the malformed hearts, the sinus deviated from its anticipated course in the atrioventricular groove, ascending obliquely on the left atrial inferior wall to meet the left oblique vein. The maximal deviation coincided in all hearts with the point where the left oblique vein joined the left-sided-circumflex vein to form the coronary sinus. We describe a circumflex vein, rather than the great cardiac vein, as the latter venous channel is right-sided in the setting of corrected transposition. The length of the sinus correlated positively with the diameter of the tricuspid valve (p=0.02). Compared with controls, the left oblique vein in the malformed hearts joined the circumflex venous channel significantly closer to the mouth of the sinus. The unexpected course of the coronary sinus in corrected transposition and the naming of the cardiac veins have important implications for venous cannulation and interpretation of images.

Differential diagnosis of wide QRS tachycardias: comparison of two electrocardiographic algorithms.

AIMS: This study's aim is to compare the ability of two ECG criteria to differentiate ventricular (VT) from supraventricular tachycardia (SVT): Brugada et al. [horizontal plane (HP) leads] and Vereckei et al. [frontal plane (FP), specifically aVR lead], having electrophysiological study (EPS) as gold standard. After comparing, suggestions for better diagnosis of wide QRS-complex tachycardia (WCT) in emergency situations were made. METHODS AND RESULTS: Fifty-one consecutive patients with 12-lead ECG registered during EPS-induced regular WCT were selected. Each ECG was split into two parts: HP (V1-V6) and FP (D1-D3, aVR, aVL, and aVF), randomly distributed to three observers, blinded for EPS diagnosis and complementary ECG plane, resulting in total 306 ECG analyses. Observers followed the four steps of both algorithms, counting time-to-diagnosis. Global sensitivity, specificity, percentage of incorrect diagnoses, and step-by-step positive/negative likelihood ratios (+LR and -LR) were calculated. Kaplan-Meier curve was plotted for final time-to-diagnosis. Inter-observer agreement was assessed with kappa-statistic. Global sensitivity was similarly high in FP and HP algorithms (89.2 vs. 90.1%), and incorrect classifications were 27.4 vs. 24.7%. Forty-eight correct analyses by Vereckei criteria took 9.13 s to diagnose VT in the first step, showing that first step was fast, with high +LR, generating nearly conclusive pre- (72.6%) to post-test (98.0%) changes for VT probability. CONCLUSION: Both algorithms as a whole are similar for diagnosis of WTC; however, the first step of Vereckei (initial R in aVR) is a simple, reproducible, accurate, and fast tool to use. The negativity of this step requires a 'holistic' approach to distinguish VT from SVT.