Septal Ablation with Radiofrequency Catheters Guided by Echocardiography for Treatment of Patients with Obstructive Hypertrophic Cardiomyopathy: Initial Experience. / Ablação Septal com Cateteres e Radiofrequência Guiada pela Ecocardiografia para Tratamento de Pacientes com Cardiomiopatia Hipertrófica Obstrutiva: Experiência Inicial.

BACKGROUND: Hypertrophic cardiomyopathy (HCM) can cause obstruction in the left ventricular outflow tract (LVOT), and be responsible for the onset of limiting symptoms, such as tiredness. When such symptoms are refractory to pharmacological treatment, interventionist alternative therapies can be useful, such as septal ablation through the infusion of alcohol in the coronary artery or through myectomy. Recently, the use of a radiofrequency (RF) catheter for endocardial septal ablation guided by electroanatomic mapping has proven to be efficient, despite the high incidence of complete atrioventricular block. An alternative would be the application of RF at the beginning point of the septal gradient guided by the transesophageal echocardiography (TEE). The echocardiography is an imaging method with high accuracy to determine septal anatomy. OBJECTIVE: To assess the long term effect of septal ablation for the relief of ventricular-arterial gradient, using TEE to help place the catheter in the area of larger septal obstruction. Besides, to assess the effects of ablation on the functional class and echocardiographic parameters. METHODS: Twelve asymptomatic patients, with LVOT obstruction, refractory to pharmacological therapy, underwent endocardial septal ablation with 8mm-tip catheters, whose placement was oriented in the region of larger obstruction, assisted by the TEE. Temperature-controlled and staggered RF applications were performed. After each application, the gradient was reassessed and a new application was performed according to the clinical criterion. The effects of RF applications were assessed both for the gradient at rest and for that provoked by the Valsalva maneuver, and considering the gradient. The differences were significant when p-value was lower than or equal to 0.05. RESULTS: It was possible to observe that the mean reduction of the maximum gradients was from 96.8±34.7 mmHg to 62.7±25.4 mmHg three months after the procedure (p=0.0036). After one year, the mean of maximum gradient was 36.1±23.8 mmHg (p=0.0001). The procedure was well tolerated, without records of complete atrioventricular block nor severe complications. CONCLUSION: The TEE-guided septal ablation was efficient and safe, and the results were maintained during the clinical follow-up period. It is a reasonable option for the interventionist treatment of LVOT obstruction in HCM.

FUNDAMENTOS: A cardiomiopatia hipertrófica (CMH) pode causar obstrução da via de saída do ventrículo esquerdo (VSVE) e ser responsável pelo surgimento de sintomas limitantes, como cansaço físico. Quando tais sintomas são refratários ao tratamento farmacológico, os tratamentos alternativos intervencionistas podem ser úteis, como a ablação septal por meio da infusão de álcool na artéria coronária ou por meio da miectomia cirúrgica. Recentemente, o uso de cateter de radiofrequência (RF) para ablação do septo endocárdico guiado por mapeamento eletroanatômico mostrou-se eficaz apesar da elevada incidência de bloqueio atrioventricular total. Uma alternativa seria a aplicação de radiofrequência no ponto de início do gradiente septal guiada pelo ecocardiograma transesofágico (ETE). O ecocardiograma é um método de imagem com elevada acurácia para determinação da anatomia septal. OBJETIVO: Avaliar o efeito em longo prazo da ablação septal para alívio do gradiente ventrículo-arterial, utilizando o ETE para auxiliar no posicionamento do cateter na área de maior obstrução septal. Avaliar também os efeitos da ablação na classe funcional e parâmetros ecocardiográficos. MÉTODOS: Doze pacientes sintomáticos com obstrução da VSVE, refratários à terapia farmacológica, foram submetidos à ablação endocárdica septal com cateteres com ponta de 8 mm, cujo posicionamento foi orientado na região de maior obstrução com auxílio do ETE. Foram realizadas aplicações de radiofrequência (RF) termocontrolada e escalonadas sobre a área alvo. Após cada aplicação, o gradiente era reavaliado e nova aplicação era realizada de acordo com critério clínico. Foram avaliados os efeitos das aplicações de RF tanto para o gradiente em repouso como para o provocado por meio da manobra de Valsalva, e considerado o gradiente. As diferenças foram significativas quando o valor de p foi menor ou igual a 0,05. RESULTADOS: Observou-se que a redução da média dos gradientes máximos obtidos foi de 96,8±34,7 mmHg para 62,7±25,4 mmHg ao final de três meses do procedimento (p=0,0036). Após um ano, a média dos gradientes máximos obtidos foi de 36,1±23,8 mmHg (p=0,0001). O procedimento foi bem tolerado e não houve registro de bloqueio atrioventricular total e nem complicações graves. CONCLUSÃO: A ablação septal guiada pelo ETE foi eficaz e segura, com resultados mantidos durante o período de seguimento clínico. É uma opção razoável para o tratamento intervencionista da obstrução da VSVE em CMH.

Clinical outcomes according to lesion complexity in patients with high bleeding risk treated with 1-month dual antiplatelet therapy following pci: analysis from the onyx one clear study

BACKGROUND Safety and effectiveness outcomes were examined at 1 year among high bleeding risk (HBR) patients treated with 1 month of dual antiplatelet therapy (DAPT) following PCI with zotarolimus eluting stents (ZES) (Resolute Onyx, Medtronic, Santa Rosa, Califor nia) according to lesion complexity (Table). METHODS The 1-year clinical outcomes were evaluated in HBR pa tients treated with ZES who were event-free following 1-month DAPT post-procedure with planned single antiplatelet therapy thereafter. Propensity score adjustment was performed to account for baseline differences (Table). RESULTS A total of 1,506 patients were stratified by complex (n » 395) or noncomplex (n » 1,111) PCI criteria (Table). Complex patients were more frequently men (72.2% vs. 66.1%; p » 0.03) and had higher rates of prior myocardial infarction (MI) (34.4% vs. 23.4%), prior CABG (24.1% vs. 8.9%), multivessel disease (78.2% vs. 39.8%), and B2/C lesion classification (84.2% vs. 75.6%), all p < 0.001. Complex patients had more lesions treated (1.7 vs. 1.2), longer stent length per patient (65.1 mm vs. 26.9 mm), and longer procedure time (58.8 min vs. 35.3 min), all p < 0.001. Procedural success was higher among noncomplex patients (90.8% vs. 82.0%; p < 0.001). In unadjusted analysis, the rate of MI was higher in patients with complex lesions (p » 0.04). How ever, no significant differences in any outcomes between patients with and without complex lesions were present after propensity score adjustment (Table). CONCLUSION Despite greater anatomic and procedural complexity, similar safety and effectiveness were observed in complex and noncomplex patients treated with 1-month DAPT following PCI with Resolute Onyx ZES after propensity score adjustment. These findings support 1-month DAPT among selected HBR patients undergoing PCI with Resolute Onyx ZES irrespective of lesion and procedural complexity.

Effect of Preloading With High Dose of Rosuvastatin on Serum Levels of Inflammatory Markers After Percutaneous Coronary Intervention.

OBJECTIVES: We sought to assess the effects of a high loading dose of rosuvastatin (40 mg) on acute inflammatory response after coronary stenting. METHODS: Patients with stable coronary disease without statin use (≥7 days) and undergoing elective percutaneous coronary intervention (PCI) in a native coronary artery were randomized to receive a loading dose of rosuvastatin (n = 64) or not (n = 61). Blood samples were obtained before statin intake (time point A), 3 hours after medication (time point B), and 3 hours after PCI (time point C). The primary goal was the comparison in the variation of the serum inflammatory markers and their gene expression at the different time points between the two groups. RESULTS: Baseline clinical, angiographic, and procedural characteristics did not significantly differ between the groups, except for the more frequent use of postdilation in the control group (73.4% vs 90.2%; P=.02). Patients pretreated with statin showed a reduction in the serum levels of interleukin (IL)-1ß (Δ = -0.491 pg/mL; Pinteraction<.001), IL-6 (Δ = -0.209 pg/mL; Pinteraction<.001), and plasminogen activator inhibitor 1 (Δ = -1.573 pg/mL; Pinteraction<.001) as well as in their genetic expression, which was not observed in the control group. Regarding high-sensitivity c-reactive protein, there was no significant variation in its value from time point A to C in patients pretreated with statin (P=.58) while it significantly increased in the control group (P=.04). CONCLUSIONS: Among patients with stable coronary artery disease undergoing PCI with stents, pretreatment with high dose of rosuvastatin resulted in significant reduction in the serum levels of important inflammatory markers and their genetic expression.

In vivo serial invasive imaging of the second-generation drug-eluting absorbable metal scaffold (Magmaris - DREAMS 2G) in de novo coronary lesions: Insights from the BIOSOLVE-II First-In-Man Trial.

RATIONALE: Bioresorbable scaffolds may confer clinical benefit in long-term studies; early mechanistic studies using intravascular imaging have provided insightful information about the immediate and mid-term local serial effects of BRS on the coronary vessel wall. OBJECTIVES: We assessed baseline, 6- and 12-month imaging data of the drug-eluting absorbable metal scaffold (DREAMS 2G). METHODS AND RESULTS: The international, first-in-man BIOSOLVE-II trial enrolled 123 patients with up to 2 de novo lesions (in vessels of 2.2 to 3.7mm). Angiographic based vasomotion, curvature and angulation were assessed; intravascular ultrasound (IVUS) derived radiofrequency (RF) data analysis and echogenicity were evaluated; optical coherence tomography (OCT) attenuation and backscattering analysis were also performed. There was hardly any difference in curvature between pre-procedure and 12months (-0.0019; p=0.48). The change in angulation from pre- to 12months was negligible (-3.58°; 95% CI [-5.97, -1.20]), but statistically significant. At 6months, the change in QCA based minimum lumen diameter in response to high dose of acetylcholine and IVUS-RF necrotic core percentage showed an inverse relationship (estimate of -0.489; p=0.055) and with fibrous volume a positive relationship (estimate of 0.53, p=0.035). Bioresorption analysis by OCT showed that the maximum attenuation values decreased significantly from post-procedure at 6months (Δ 6months vs. post-proc. is -13.5 [95% CI -14.6, -12.4]) and at 12months (Δ 12months vs. post-proc. is -14.0 [95% CI -15.4, -12.6]). By radiofrequency data, the percentage of dense calcium decreased significantly from post-procedure at 6months and at 12months. Likewise, by echogenicity, hyperechogenic structures decreased significantly from post-procedure at 6months; thereafter, they remained unchanged. CONCLUSION: Following implantation of DREAMS 2G, restoration of the vessel geometry, vasomotion and bioresorption signs were observed at up to 12months; importantly, these changes occurred with preservation of the lumen size between 6 and 12months. NCT01960504.

In vivo serial invasive imaging of the second-generation drug-eluting absorbable metal scaffold (Magmaris — DREAMS 2G) in de novo coronary lesions: Insights from the BIOSOLVE-II First-In-Man Trial

RATIONALE: Bioresorbable scaffolds may confer clinical benefit in long-term studies; early mechanistic studies using intravascular imaging have provided insightful information about the immediate and mid-term local serial effects of BRS on the coronary vessel wall. OBJECTIVES: We assessed baseline, 6- and 12-month imaging data of the drug-eluting absorbable metal scaffold (DREAMS 2G). METHODS AND RESULTS: The international, first-in-man BIOSOLVE-II trial enrolled 123 patients with up to 2 de novo lesions (in vessels of 2.2 to 3.7mm). Angiographic based vasomotion, curvature and angulation were assessed; intravascular ultrasound (IVUS) derived radiofrequency (RF) data analysis and echogenicity were evaluated; optical coherence tomography (OCT) attenuation and backscattering analysis were also performed. There was hardly any difference in curvature between pre-procedure and 12months (-0.0019; p=0.48). The change in angulation from pre- to 12months was negligible (-3.58°; 95% CI [-5.97, -1.20]), but statistically significant. At 6months, the change in QCA based minimum lumen diameter in response to high dose of acetylcholine and IVUS-RF necrotic core percentage showed an inverse relationship (estimate of -0.489; p=0.055) and with fibrous volume a positive relationship (estimate of 0.53, p=0.035). Bioresorption analysis by OCT showed that the maximum attenuation values decreased significantly from post-procedure at 6months (Δ 6months vs. post-proc. is -13.5 [95% CI -14.6, -12.4]) and at 12months (Δ 12months vs. post-proc. is -14.0 [95% CI -15.4, -12.6]). By radiofrequency data, the percentage of dense calcium decreased significantly from post-procedure at 6months and at 12months...

Evaluation of the Safety and Efficacy of the Novel Svelte Acrobat Integrated Delivery System via Radial Approach With 5 Fr Catheters.

PURPOSE: To evaluate the safety and efficacy of the Svelte Acrobat integrated delivery system (IDS) via radial approach with 5 Fr catheters. The direct stenting (DS) system enables easy delivery, deployment, and postdilatation of a cobalt-chromium stent. METHODS: Patients with coronary artery disease (CAD) were prospectively enrolled at three centers to undergo percutaneous coronary intervention with DS via radial approach using 5 Fr catheters. The primary endpoint was IDS success, which was defined as DS without postdilatation and final stenosis <20% with Thrombolysis in Myocardial Infarction (TIMI)-3 flow. RESULTS: Fifty consecutive patients with 55 lesions were included. The procedure success rate was 98%. The device could not cross the lesion in 2 cases, so DS success was 96%. Fifty lesions met the primary study objective; thus, IDS success rate was 91%. The procedure duration was 21 ± 9 minutes, fluoroscopy time was 7.3 ± 4.7 minutes, and contrast volume per vessel was 103 ± 33 cm3. The final residual stenosis, by quantitative coronary angiography, was 3.4 ± 4%. The reduced need for additional catheters resulted in a 20% procedural cost reduction. There were no bleeding or vascular complications. At 8 months, the event-free survival rate was 84%. CONCLUSIONS: DS using the Svelte Acrobat IDS via radial approach with low-profile catheters is safe and efficacious in select coronary artery disease patients, and its use is associated with potential procedural cost savings.

Infarto agudo do miocárdio por dissecção espontânea de artérias coronárias: série de cinco casos / Acute myocardial infarction due to spontaneous coronary artery dissection - a series of five cases

Relatamos série de 5 pacientes internados por síndrome coronária aguda, entre 2008 e 2010, nos quais a cinecoronariografia evidenciou dissecção coronária espontânea. A dissecção coronária espontânea é uma causa rara de infarto do miocárdio, mais comumente observada em indivíduos jovens e sem histórico de doenças cardiovasculares. O manejo ideal é incerto, principalmente pela limitada experiência clínica com essa entidade. A ultrassonografia intracoronária é uma ferramenta útil tanto para o diagnóstico da dissecção coronária espontânea como para guiar o tratamento percutâneo.

We report a series of five patients hospitalized due to acute coronary syndrome, from 2008 to 2010, in whom coronary angiography showed spontaneous coronary dissection. Spontaneous coronary artery dissection is a rare cause of acute myocardial infarction, most commonly seen in young individuals with no history of cardiovascular disease. The optimal management is uncertain, especially due to the limited clinical experience with this entity. Intravascular ultrasound is a useful tool to diagnose spontaneous coronary artery dissection as well as to guide percutaneous therapy.