Rogério Sarmento-Leite

Predictive factors, management, and clinical outcomes of coronary obstruction following transcatheter aortic valve implantation: Insights from a large multicenter registry

OBJECTIVES This study sought to evaluate the main baseline and procedural characteristics, management, and clinical outcomes of patients from a large cohort of patients undergoing transcatheter aortic valve implantation (TAVI) who suffered coronary obstruction (CO). BACKGROUND Very little data exist on CO following TAVI. METHODS This multicenter registry included 44 patients who suffered symptomatic CO following TAVI of 6,688 patients (0.66%). Pre-TAVI computed tomography data was available in 28 CO patients and in a control group of 345 patients (comparisons were performed including all patients and a cohort matched 1:1 by age, sex, previous coronary artery bypass graft, transcatheter valve type, and size). RESULTS Baseline and procedural variables associated with CO were older age (p < 0.001), female sex (p < 0.001), no previous coronary artery bypass graft (p = 0.043), the use of a balloon-expandable valve (p = 0.023), and previous surgical aortic bioprosthesis (p = 0.045). The left coronary artery was the most commonly involved (88.6%). The mean left coronary artery ostia height and sinus of Valsalva diameters were lower in patients with obstruction than in control subjects (10.6 ± 2.1 mm vs. 13.4 ± 2.1 mm, p < 0.001; 28.1 ± 3.8 mm vs. 31.9 ± 4.1 mm, p < 0.001). Differences between groups remained significant after the case-matched analysis (p < 0.001 for coronary height; p = 0.01 for sinus of Valsalva diameter). Most patients presented with persistent severe hypotension (68.2%) and electrocardiographic changes (56.8%). Percutaneous coronary intervention was attempted in 75% of the cases and was successful in 81.8%. Thirty-day mortality was 40.9%. After a median follow-up of 12 (2 to 18) months, the cumulative mortality rate was 45.5%, and there were no cases of stent thrombosis or reintervention. CONCLUSIONS Symptomatic CO following TAVI was a rare but life-threatening complication that occurred more frequently in women, in patients receiving a balloon-expandable valve, and in those with a previous surgical bioprosthesis. Lower-lying coronary ostium and shallow sinus of Valsalva were associated anatomic factors, and despite successful treatment, acute and late mortality remained very high, highlighting the importance of anticipating and preventing the occurrence of this complication.

Assessing Myocardial Viability and Infarct Transmurality With Left Ventricular Electromechanical Mapping in Patients With Stable Coronary Artery Disease Validation by Delayed-Enhancement Magnetic Resonance Imaging

Background—This study was designed to define myocardial viability and establish practical cut-off values for differentiating normal myocardial tissue from subendocardial and transmural scar tissue by using electromechanical mapping (EMM). We validated our results by delayed-enhancement cardiac MRI (DE-MRI). Methods and Results—We prospectively studied 15 ambulatory patients with stable coronary disease who were candidates for cardiac catheterization. Within 48 hours of EMM, DE-MRI was performed. Using EMM software, we created a bull’s eye precisely matched to that generated by DE-MRI. Segment by segment, we compared the MRI results to the corresponding unipolar voltage value for that same segment in the EMM bull’s eye. Of 300 total segments, 275 were compared. The segments were divided into normal (n=211), subendocardial scar (n=49), and transmural scar (n=15). We found that subendocardial (6.8±2.9 mV) and transmural (4.6±1.9 mV) scar segments had significantly less unipolar voltage than normal (11.6±4.5 mV) segments (P <0.05 for each comparison). When normal myocardium was compared with myocardium with subendocardial scar, the threshold for differentiating between the two areas was 7.9 mV (sensitivity, 80%; specificity, 80%). Comparison of normal tissue to transmural scar yielded a threshold of 6.9 mV (sensitivity, 93%; specificity, 88%). Conclusions—Our results demonstrate that normal myocardium can be accurately distinguished from myocardium with subendocardial or transmural infarcts on the basis of unipolar voltage values obtained through EMM. This is the first study to validate these results by using cardiac DE-MRI in humans.

Late Cardiac Death in Patients Undergoing Transcatheter Aortic Valve Replacement Incidence and Predictors of Advanced Heart Failure and Sudden Cardiac Death

BACKGROUND Little evidence exists of the burden and predictors of cardiac death after transcatheter aortic valve replacement (TAVR). OBJECTIVES The purpose of this study was to assess the incidence and predictors of cardiac death from advanced heart failure (HF) and sudden cardiac death (SCD) in a large patient cohort undergoing TAVR. METHODS The study included a total of 3,726 patients who underwent TAVR using balloon (57%) or self-expandable (43%) valves. Causes of death were defined according to the Valve Academic Research Consortium-2. RESULTS At a mean follow-up of 22 ± 18 months, 155 patients had died due to advanced HF (15.2% of total deaths, 46.1% of deaths from cardiac causes) and 57 had died due to SCD (5.6% of deaths, 16.9% of cardiac deaths). Baseline comorbidities (chronic obstructive pulmonary disease, atrial fibrillation, left ventricular ejection fraction ≤40%, lower mean transaortic gradient, pulmonary artery systolic pressure >60 mm Hg; p < 0.05 for all) and 2 procedural factors (transapical approach, hazard ratio [HR]: 2.38, 95% confidence interval [CI]: 1.60 to 3.54; p < 0.001; presence of moderate or severe aortic regurgitation after TAVR, HR: 2.79, 95% CI: 1.82 to 4.27; p < 0.001) independently predicted death from advanced HF. Left ventricular ejection fraction ≤40% (HR: 1.93, 95% CI: 1.05 to 3.55; p = 0.033) and new-onset persistent left bundle-branch block following TAVR (HR: 2.26, 95% CI: 1.23 to 4.14; p = 0.009) were independently associated with an increased risk of SCD. Patients with new-onset persistent left bundle-branch block and a QRS duration >160 ms had a greater SCD risk (HR: 4.78, 95% CI: 1.56 to 14.63; p = 0.006). CONCLUSIONS Advanced HF and SCD accounted for two-thirds of cardiac deaths in patients after TAVR. Potentially modifiable or treatable factors leading to increased risk of mortality for HF and SCD were identified. Future studies should determine whether targeting these factors decreases the risk of cardiac death.

Outcomes and predictors of mortality after transcatheter aortic valve implantation: Results of the Brazilian registry

The study sought to evaluate outcomes and predictors of mortality after transcatheter aortic valve implantation (TAVI).

Transcatheter closure of atrial septal defect with Amplatzer® device in children aged less than 10 years old: Immediate and late follow-up

Aims: To analyze the efficacy and follow‐up results of percutaneous closure of Atrial septal defect (ASD) with the Amplatzer® septal occluder in children aged <10 years old. Methods: Between November 1998 and September 2005, 27 patients diagnosed with ASD were treated percutaneously with an Amplatzer septal occluder. The procedure was carried out in the cathlab, under general anesthesia and with both fluoroscopy and transesophageal echocardiography guidance. Basal physical examinations and echocardiograms were performed prior to the procedure and at 30 days, 6, and 12 months of follow‐up. Survival free of symptom was estimated by Kaplan–Meier. Results: The mean age, weight, height, body mass index, and corporal surface was: 5.35 ± 2.11 years, 23.07 ± 9.43 kg, 110.55 ± 17.6 cm, 16.77 ± 2.42 kg/m2, and 1.24 ± 2.44 m2. The prevalence of septal aneurysm was 3.7% and all patients presented single secundum ASD. The mean stretched diameter by fluoroscopy and transesophageal echocardiography were 17.18 ± 6.75 mm and 16.77 ± 5.99 mm, and the prostheses sizes were 18.83 ± 6.98 mm, ranging from 10 to 30 mm. The systolic and diastolic pulmonary pressures were 25.26 ± 5.97 mm Hg and 13.38 ± 3.40 mm Hg, respectively. The procedure time was 82.92 ± 29.14 min and the hospital stay was 2.20 ± 0.26 days. Clinical and echocardiography follow‐ups were performed within 11.59 ± 4.42 months and all devices were in the correct position with no residual shunt. Right ventricular diameter decreased from 19.38 ± 5.23mm to 11.38 ± 11.92 (P 0.001). No major complications or deaths occurred; two patients had a hematoma at the vascular access. Conclusion: Secundum atrial septal defect closure can be safely and successfully performed with the Amplatzer septal occluder in children younger than 10 years old.

Early sheath removal and ambulation in patients submitted to percutaneous coronary intervention: A randomised clinical trial

INTRODUCTION Despite recent technical improvements and device developments, post-percutaneous coronary intervention care in patients submitted to this procedure performed through the femoral approach remains almost unchanged. An earlier sheath removal and ambulation could help to cut costs, save health system resources and prevent patient discomfort. However, this approach has not yet been well assessed. OBJECTIVES The main objective of this paper was to evaluate a strategy of post-procedure immediate sheath removal and early ambulation. METHODS A randomised trial was conducted in 347 patients submitted to percutaneous coronary intervention that used a 6 French gauge arterial sheath. The intervention group (IG, n=172) had the arterial sheath removed immediately after the procedure and ambulated after 3 h of bed rest. The control group (CG, n=175) had the arterial sheath removed 4h after the end of the angioplasty and rested for an additional 6 h. The primary end point was the development of major vascular complications: hematoma>10 cm, pseudo-aneurism and arterial bleeding after or during ambulation. Secondary end points were minor vascular complications: hematoma<10 cm, vasovagal reactions after sheath removal, and assessment of patients comfort during the peri-operative period. RESULTS Baseline characteristics did not differ statistically between groups, as major bleeding (IG=1.7% vs. CG=0.6%; p=0.31). Regarding other vascular complications and vasovagal reactions, there were also no significant differences. Patients of IG had less pain (26% vs. 41%, p=0.004) than CG, but the frequency of urinary retention was the same in both groups. CONCLUSION This study, although underpowered, indicates that immediate arterial sheath removal with early ambulation after PCI was not significantly associated with an increase in major vascular complications and was associated with increased patient comfort. Although further studies with larger samples are necessary to confirm these results, this study suggests that immediate arterial sheath removal with early ambulation may be an alternative for selected elective patients submitted to percutaneous coronary interventions and for those with difficulties to endure prolonged bed rest.

Insulin resistance and triglyceride/HDLc index are associated with coronary artery disease

BackgroundInsulin-resistance is associated with cardiovascular disease but it is not used as a marker for disease in clinical practice.AimsTo study the association between the homeostatic model assessment (HOMA-IR) and triglyceride/HDLc ratio (TG/HDLc) with the presence of coronary artery disease in patients submitted to cardiac catheterization.MethodsIn a cross-sectional study, 131 patients (57.0 ± 10 years-old, 51.5% men) underwent clinical, laboratory and angiographic evaluation and were classified as No CAD (absence of coronary artery disease) or CAD (stenosis of more than 30% in at least one major coronary artery).ResultsPrevalence of coronary artery disease was 56.7%. HOMA-IR and TG/HDLc index were higher in the CAD vs No CAD group, respectively: HOMA-IR: 3.19 (1.70-5.62) vs. 2.33 (1.44-4.06), p = 0.015 and TG/HDLc: 3.20 (2.38-5.59) vs. 2.80 (1.98-4.59) p = 0.045) - median (p25-75). After a ROC curve analysis, cut-off values were selected based on the best positive predictive value for each variable: HOMA-IR = 6.0, TG/HDLc = 8.5 and [HOMA-IR×TG/HDLc] = 28. Positive predictive value for coronary artery disease for HOMA-IR>6.0 was 82.6%, for TG/HDLc>8.5 was 85.7% and for [HOMA-IR×TG/HDLc]>28 was 88.0%. Adjusted relative risk (age, gender, diabetes, body mass index, systolic blood pressure) for the presence of coronary artery disease was: for HOMA-IR>6.0, 1.47 (95.CI: 1.06-2.04, p = 0.027), for TG/HDLc>8.5, 1.46 (95% CI:1.07-1.98), p = 0.015) and for [HOMA-IR × TG/HDLc] >28, 1.64 (95%CI: 1.28-2.09), p < 0.001).ConclusionsIncreased HOMA-IR, TG/HDLc and their product are positively associated with angiographic coronary artery disease, and may be useful for risk stratification as a high-specificity test for coronary artery disease.

Preditores de mudança na qualidade de vida após um evento coronariano agudo

BACKGROUND The assessment of quality of life (QOL), identifying functional capacity and frequency of angina and other cardiac symptoms, are key issues in the treatment of chronic patients or in those with disease instability. OBJECTIVE To identify predictors of quality of life (QOL) improvement in patients with non-ST segment elevation acute coronary syndrome (NSTEACS). METHODS Patients hospitalized in a cardiology reference hospital were assessed with the Seattle Angina Questionnaire (SAQ) at the time of admission and after 6 months. The analyzed outcome was the variation of the QOL score, resulting from the difference between the score after six months and the score at the time of admission. Differences between patients with or without 6-month QOL improvements regarding the demographic, clinical and therapeutic characteristics were assessed by univariate and multivariate analysis. RESULTS Hypertensive patients presented lower improvement in QOL scores when compared to non-hypertensive ones [8.3(0-25) vs. 16.6(0-33.3); P=0.05], as well as patients with dyslipidemia, when compared to non-dyslipidemic ones [8.3(0-25) vs. 16.6(0-33.3); P=0.02]. Patients with unstable angina presented greater improvements in QOL in relation to those with NSTE myocardial infarction [16.6(0-33.3) vs. 8.3(-8.3-25); P=0.03]. By multivariate analysis, myocardial revascularization in the first 30-days was associated with the greater improvement in the QOL score (8.47 points; P=0.005). On the other side, the presence of dyslipidemia at the baseline evaluation was an independent predictor of worse QOL scores (-7.2 points; P=0.01). CONCLUSION Myocardial revascularization was associated with improvement in the 6-month QOL scores, while dyslipidemia was associated with worse scores.

'Correction:' Serum transforming growth factor beta-1 (TGF-beta-1) levels in diabetic patients are not associated with pre-existent coronary artery disease

BackgroundThe association between TGF-β1 levels and long-term major adverse cardiovascular events (MACE) in patients with coronary artery disease (CAD) is controversial. No study specifically addressed patients with CAD and diabetes mellitus (DM). The association between TGF-β1 levels and long-term major adverse cardiovascular events (MACE) in patients with coronary artery disease (CAD) is controversial. No study specifically addressed patients with CAD and diabetes mellitus (DM).MethodsPatients (n = 135, 30–80 years) referred for coronary angiography were submitted to clinical and laboratory evaluation, and the coronary angiograms were evaluated by two operators blinded to clinical characteristics. CAD was defined as the presence of a 70% stenosis in one major coronary artery, and DM was characterized as a fasting glycemia > 126 mg/dl or known diabetics (personal history of diabetes or previous use of anti-hyperglycemic drugs or insulin). Based on these criteria, study patients were classified into four groups: no DM and no CAD (controls, C n = 61), DM without CAD (D n = 23), CAD without DM (C-CAD n = 28), and CAD with DM (D-CAD n = 23). Baseline differences between the 4 groups were evaluated by the χ2 test for trend (categorical variables) and by ANOVA (continuous variables, post-hoc Tukey). Patients were then followed-up during two years for the occurrence of MACE (cardiac death, stroke, myocardial infarction or myocardial revascularization). The association of candidate variables with the occurrence of 2-year MACE was assessed by univariate analysis.ResultsThe mean age was 58.2 ± 0.9 years, and 51% were men. Patients with CAD had a higher mean age (p = 0.011) and a higher percentage were male (p = 0.040). There were no significant baseline differences between the 4 groups regarding hypertension, smoking status, blood pressure levels, lipid levels or inflammatory markers. TGF-β1 was similar between patients with or without CAD or DM (35.1 ×/÷ 1.3, 33.6 ×/÷ 1.6, 33.9 ×/÷ 1.4 and 31.8 ×/÷ 1.4 ng/ml in C, D, C-CAD and D-CAD, respectively, p = 0.547). In the 2-year follow-ip, independent predictors of 2-year MACE were age (p = 0.007), C-reactive protein (p = 0.048) and systolic blood pressure (p = 0.008), but not TGF-β1.ConclusionSerum TGF-β1 was not associated with CAD or MACE occurrence in patients with or without DM.

Efetividade da prótese de Amplatzer™ para fechamento percutâneo do defeito do septo interatrial tipo Ostium Secundum

OBJETIVO: Avaliar a efetividade da protese de Amplatzer® para tratamento de comunicacao interatrial tipo ostium secundum (CIA OS). METODOS: Estudo de coorte historica entre novembro de 1998 e setembro de 2005, em que foram realizados 101 procedimentos para oclusao percutânea de CIA OS em nossa instituicao. Os procedimentos foram efetuados no laboratorio de hemodinâmica, sob anestesia geral e com monitorizacao por ecocardiografia transesofagica (ETE). Os pacientes foram acompanhados clinicamente e com ecocardiografia em 30 dias, seis meses e depois anualmente. O resultados sao apresentados em media, desvio padrao e porcentual, e a sobrevida livre de eventos foi estimada pela curva de Kaplan-Meier. RESULTADOS: Dos 101 pacientes, 60 (59,4%) eram mulheres. As medias para idade, peso, altura, indice de massa corporal e superficie corporal foram, respectivamente, de 24,3 + 18,31 anos, 51,88 + 23,76 kg, 140,59 + 39,3 cm, 23,18 + 18,9 kg/m2, e 1,24 + 0,21 m2. A prevalencia de aneurisma do septo interatrial foi de 4,95%, e 98 casos eram de defeito unico. O diâmetro das CIAs foi de 21,47 + 6,96 mm pela angiografia e de 21,22 + 7,93 mm pela ETE. As proteses implantadas mediam 23,92 + 7,25 mm, variando de 9 mm a 40 mm. O tempo de procedimento foi de 90,47 + 26,67 minutos e a media de internacao hospitalar, de 2,51 + 0,62 dias. Os seguimentos clinico e ecocardiografico ocorreram com 12,81 + 8,41 meses e todas as proteses estavam bem ancoradas e sem shunt residual. O sucesso do procedimento foi de 93% (94/101). Em cinco casos nao se conseguiu liberacao adequada do dispositivo e dois pacientes apresentaram CIA residual. Nao foram registradas complicacoes maiores. CONCLUSAO: A protese de Amplatzer® mostrou-se efetiva para o tratamento percutâneo de CIA OS.