Safety and efficacy of balloon pulmonary angioplasty in a Portuguese pulmonary hypertension expert center.

INTRODUCTION: Balloon pulmonary angioplasty (BPA) is an alternative therapy in patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) or residual/recurrent pulmonary hypertension (PH) after surgery. The aim of this study was to assess the short-term efficacy and safety of a BPA program. METHODS: This prospective single-center study included all BPA sessions performed in CTEPH patients between 2017 and 2019. Clinical assessment including WHO functional class, plasma biomarkers, 6-min walk test (6MWT) and right heart catheterization was performed at baseline and six months after the last BPA session. RESULTS: A total of 57 BPA sessions were performed in 11 CTEPH patients (64% with inoperable disease, 82% under pulmonar vasodilator therapy). Nine patients completed both the BPA program and a minimum six-month follow-up period. There were significant improvements in WHO functional class (p=0.004) and 6MWT (mean increase of 42 m; p=0.050) and a trend for significant hemodynamic improvement: 25% decrease in mean pulmonary artery pressure (mPAP) (p=0.082) and 42% decrease in pulmonary vascular resistance (PVR) (p=0.056). In the group of patients with severely impaired hemodynamics (three patients with mPAP >40 mmHg), the reduction was significant: 51% in mPAP (p=0.013) and 67% in PVR (p=0.050). Prostacyclin analogs and long-term oxygen therapy were withdrawn in all patients. Minor complications were recorded in 25% of patients. There were no major complications or deaths. CONCLUSIONS: A BPA strategy on top of pulmonary vasodilator therapy further improves symptoms, exercise capacity and hemodynamics with an acceptable risk-benefit ratio in patients with inoperable CTEPH or residual/recurrent PH after surgery.

Balloon pulmonary angioplasty protocol in a Portuguese pulmonary hypertension expert center.

INTRODUCTION: Balloon pulmonary angioplasty (BPA) has emerged as a promising therapeutic option for patients with chronic thromboembolic pulmonary hypertension (CTEPH) who are not eligible for pulmonary thromboendarterectomy (PEA) or who have recurrent or persistent pulmonary hypertension after surgery. There is no standardized technique for BPA and, its complexity and high risk of severe complications, requires skills and appropriate training and should be reserved for expert CTEPH centers, as a complementary intervention to medical and surgical therapy. OBJECTIVE: The purpose of this document is to describe the BPA protocol used at a high-volume center nationwide, validated by its results. METHODS: The present protocol includes technical details, definition of outcomes and complications, as well as patient full diagnostic work-up and treatment algorithm, before and after BPA. RESULTS: The technical, hemodynamic, and clinical results of the application of this protocol will be subject of a later publication where they will be described in detail. In conclusion, we present a percutaneous intervention protocol in the treatment of pulmonary hypertension in the context of chronic pulmonary thromboembolism, validated by its clinical, hemodynamic, and technical results.

Safety and efficacy of balloon pulmonary angioplasty in a Portuguese pulmonary hypertension expert center. / Segurança e eficácia da angioplastia pulmonar por balão em Portugal num centro de referência em hipertensão pulmonar.

INTRODUCTION: Balloon pulmonary angioplasty (BPA) is an alternative therapy in patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) or residual/recurrent pulmonary hypertension (PH) after surgery. The aim of this study was to assess the short-term efficacy and safety of a BPA program. METHODS: This prospective single-center study included all BPA sessions performed in CTEPH patients between 2017 and 2019. Clinical assessment including WHO functional class, plasma biomarkers, 6-min walk test (6MWT) and right heart catheterization was performed at baseline and six months after the last BPA session. RESULTS: A total of 57 BPA sessions were performed in 11 CTEPH patients (64% with inoperable disease, 82% under pulmonary vasodilator therapy). Nine patients completed both the BPA program and a minimum six-month follow-up period. There were significant improvements in WHO functional class (p=0.004) and 6MWT (mean increase of 42 m; p=0.050) and a trend for significant hemodynamic improvement: 25% decrease in mean pulmonary artery pressure (mPAP) (p=0.082) and 42% decrease in pulmonary vascular resistance (PVR) (p=0.056). In the group of patients with severely impaired hemodynamics (three patients with mPAP >40mmHg), the reduction was significant: 51% in mPAP (p=0.013) and 67% in PVR (p=0.050). Prostacyclin analogs and long-term oxygen therapy were withdrawn in all patients. Minor complications were recorded in 25% of patients. There were no major complications or deaths. CONCLUSIONS: A BPA strategy on top of pulmonary vasodilator therapy further improves symptoms, exercise capacity and hemodynamics with an acceptable risk-benefit ratio in patients with inoperable CTEPH or residual/recurrent PH after surgery.

Five years of Stent for Life in Portugal.

OBJECTIVE: To analyze changes in performance indicators five years after Portugal joined the Stent for Life (SFL) initiative. METHODS: National surveys were carried out annually over one-month periods designated as study Time Points between 2011 (Time Zero) and 2016 (Time Five). In this study, 1340 consecutive patients with suspected ST-elevation myocardial infarction (STEMI) who underwent coronary angiography, admitted to 18 24/7 primary percutaneous coronary intervention (PCI) centers, were enrolled. RESULTS: There was a significant reduction in the proportion of patients who attended primary healthcare centers (20.3% vs. 4.8%, p<0.001) and non-PCI-capable centers (54.5% vs. 42.5%, p=0.013). The proportions of patients who called 112, the national emergency medical services (EMS) number (35.2% vs. 46.6%, p=0.022) and of those transported via the EMS to a PCI-capable center (13.1% vs. 30.5%, p<0.001) increased. The main improvement observed in timings for revascularization was a trend toward a reduction in patient delay (114 min in 2011 vs. 100 min in 2016, p=0.050). System delay and door-to-balloon time remained constant, at a median of 134 and 57 min in 2016, respectively. CONCLUSION: During the lifetime of the SFL initiative in Portugal, there was a positive change in patient delay indicators, especially the lower proportion of patients who attended non-PCI centers, along with an increase in those who called 112. System delay did not change significantly over this period. These results should be taken into consideration in the current Stent - Save a Life initiative.

Time to reperfusion in high-risk patients with myocardial infarction undergoing primary percutaneous coronary intervention.

INTRODUCTION: Timely reperfusion with primary percutaneous coronary intervention (PPCI) in ST-segment elevation myocardial infarction (STEMI) improves patient outcomes. In recent years, the Stent for Life (SFL) initiative in Portugal developed an action plan to improve timely access to PPCI. This study aims to evaluate performance indicators in high-risk populations (elderly, female, and diabetic patients). METHODS: Data on 1340 patients with suspected STEMI who were admitted to 18 Portuguese interventional cardiology centers were collected during a one-month period every year from 2011 to 2016. The risk of longer patient and system delay in elderly, female, and diabetic patients was assessed by logistic regression analysis. RESULTS: Patient and system delays were longer in elderly patients (incremental median 32 and 40 min; p=0.001 and p<0.001, respectively). Median system delay was also longer in women (incremental median 25 min; p<0.001). Consequently, times to revascularization were longer in elderly patients (incremental median 92 min; p<0.001) and women (incremental median 67 min; p<0.001). There was no significant difference in reperfusion delay in diabetic patients. After adjustment for gender and diabetes, elderly age was an independent predictor of patient delay longer than the median (OR 1.64; 95% CI 1.22-2.20; p=0.001) and system delay >90 min (OR 2.95; 95% CI 1.84-4.72; p<0.001). CONCLUSION: Elderly patients showed longer patient and system delays, regardless of gender and presence of diabetes. These data suggest that the elderly subgroup should be the target of a new action by the SFL initiative.

The Stent for Life initiative: Factors predicting system delay in patients with ST-segment elevation myocardial infarction.

INTRODUCTION AND AIMS: System delay (time between first medical contact and reperfusion therapy) is an indicator of quality of primary percutaneous coronary intervention (pPCI) in ST-segment elevation myocardial infarction (STEMI) patients. This study aimed to assess changes in system delay between 2011 and 2015, and to identify its predictors. METHODS: The study included 838 patients admitted to 18 Portuguese interventional cardiology centers suspected of having STEMI with less than 12 hours' duration who were referred for primary percutaneous coronary intervention. Data were collected for a one-month period every year from 2011 to 2015. Univariate and multivariate logistic regression models were used to determine predictors of system delay. RESULTS: No significant changes in system delay were observed during the study. Only 27% of patients had a system delay of ≤90 min. Multivariate analysis identified four predictors of system delay: age ≥75 years (OR 2.57; 95% CI 1.50-4.59; p=0.001), attending a center without pPCI (OR 4.08; 95% CI 2.75-6.10; p<0.001), not calling the national medical emergency number (112) (OR 0.47; 95% CI 0.32-0.68; p<0.001), and Central region (OR 3.43; 95% CI 1.60-8.31; p=0.003). CONCLUSIONS: The factors age ≥75 years, attending a center without pPCI, not calling 112, and Central region were identified as predicting longer system delay. This knowledge may help in planning interventions to reduce system delay and to improve the clinical outcomes of patients with STEMI.

Factors influencing patient delay before primary percutaneous coronary intervention in ST-segment elevation myocardial infarction: The Stent for life initiative in Portugal.

INTRODUCTION AND AIMS: Shorter patient delays are associated with a better prognosis for patients diagnosed with ST-segment elevation myocardial infarction (STEMI). This study aimed to identify predictors of patient delay in the Portuguese population. METHODS: Data on 994 patients with suspected STEMI of less than 12 hours' duration and referred for primary percutaneous coronary intervention (pPCI) and admitted to 18 Portuguese interventional cardiology centers were collected for a one-month period every year from 2011 to 2015. Univariate and multivariate linear regression models were used to identify predictors of patient delay. RESULTS: No significant differences were observed in patient delay over the course of the survey. The multivariate analysis identified five predictors of patient delay: age ≥75 years (exp[beta] 1.28; 95% CI 1.10-1.50; p=0.001), symptom onset between 0:00 and 8:00 a.m. (exp[beta] 1.26; 95% CI 1.10-1.45; p=0.001), and attending a primary care unit before first medical contact (exp[beta] 1.75; 95% CI 1.41-2.16; p<0.001) predicted longer patient delay, while calling the national medical emergency number (112) (exp[beta] 0.84; 95% CI 0.71-1.00; p=0.045) and transport by the emergency medical services to the pPCI facility (exp[beta] 0.71; 95% CI 0.59-0.84; p<0.001) predicted shorter patient delay. CONCLUSIONS: We identified five factors predicting patient delay, which will help in planning interventions to reduce patient delays and to improve the outcome of patients with STEMI.

Long-term follow-up of patients with deferred coronary intervention guided by measurement of fractional flow reserve.

INTRODUCTION AND AIMS: The functional significance of coronary lesions can be assessed in the cardiac catheterization laboratory by determination of fractional flow reserve (FFR), thus overcoming one of the major limitations of conventional angiography. The aim of this study was to analyze the long-term clinical course of patients with intermediate coronary stenosis (50-70%) deferred for intervention based on FFR <0.80. METHODS: Between May 1999 and December 2009, 300 lesions in 231 patients (mean age 65 ± 10 years, 68% male and 75.3% with multivessel disease) were studied by FFR. Intervention was deferred in 282 (94%) lesions and 18 were treated based on FFR <0.80. We assessed the occurrence of major adverse cardiovascular events (MACE), defined as cardiovascular death, non-fatal acute coronary syndrome and target lesion revascularization (TLR). RESULTS: During a median follow-up of 637 days (interquartile range 455-1160), there were 15 (6.5%) MACE in the subgroup of patients with target lesion intervention deferred based on FFR: one cardiovascular death, four hospitalizations for acute coronary syndrome and 14 TLR (12 patients were treated percutaneously and two underwent coronary artery bypass grafting). MACE-free survival at one year follow-up was 97.8%. CONCLUSION: These results, in a real-world population, support the current trend to base the decision to treat on functional rather than purely anatomical criteria, in order to improve safety and efficiency.

One-year clinical outcomes of percutaneous treatment with drug-eluting balloons: results from a multicenter registry.

INTRODUCTION AND OBJECTIVES: Percutaneous coronary intervention (PCI) with paclitaxel drug-eluting balloons (DEBs) is used mainly for treatment of in-stent restenosis (ISR) and small vessel disease. Our objective was to evaluate the clinical efficacy of this strategy in a multicenter registry. METHODS: Between 2009 and 2010 a prospective registry from two centers enrolled 156 consecutive patients undergoing PCI with at least one DEB. A primary composite endpoint of major adverse cardiac events (MACE) (all-cause death, myocardial infarction [MI] and target lesion revascularization [TLR]) was assessed at one-year follow-up. Stepwise Cox regression was used to determine independent predictors of outcome. RESULTS: DEBs (n=206) were used to treat 184 lesions. Procedural success was obtained in 98% of patients (n=150). At one-year follow-up, 86% (n=134) were free of the primary endpoint (6% death, 6% non-procedure related MI and 5% TLR). The independent predictors of MACE at one year were index PCI in the left anterior descending artery (HR 2.81, 95% CI 1.21-6.51; p=0.02) and a history of MI (HR 3.46, 95% CI 1.35-8.84; p=0.01). ISR and DEB diameter or length were not predictors of events. CONCLUSIONS: PCI with DEBs in real-world patients with complex lesions is effective, with a low rate of MACE, including TLR, at one-year follow-up. The results are equally good whether the intervention is for ISR or for native coronary disease.

Contribuição do guaraná em pó (Paullinia cupana) como fonte de cafeína na dieta / Contribution of guaraná powder (Paullinia cupana) as a source of caffeine in the diet

OBJETIVO: Este estudo teve como objetivo determinar os teores de cafeína em diferentes marcas de guaraná em pó disponíveis comercialmente. MÉTODOS: A metodologia analítica utilizada envolveu as etapas de extração com água, limpeza da amostra com acetato de chumbo e determinação por cromatografia líquida de alta eficiência com detector de arranjo de diodos (200-400nm). Foram analisadas 39 amostras adquiridas nas cidades de Campinas e Ribeirão Preto, SP, entre dezembro de 2003 e janeiro de 2004. RESULTADOS: Os teores de cafeína nas amostras apresentaram grande variabilidade, situando-se na faixa de 9,52 a 36,71mg/g de pó, isso se deve, possivelmente, às diferenças de procedência e processo a que a matéria-prima foi submetida. Comparando-se com o pó de café, fonte tradicional de cafeína na dieta, verifica-se que o teor médio de cafeína encontrado no guaraná em pó, dependendo da marca considerada, pode ser até quatro vezes maior. CONCLUSÃO: Entre os consumidores de guaraná em pó esse produto pode ser considerado uma importante fonte de cafeína na dieta, e sua associação com demais produtos que contêm cafeína sugere que seu consumo deve ser controlado, uma vez que controvérsias persistem quanto à dose segura de ingestão da cafeína.

OBJECTIVE: The present study was conducted in order to determine the caffeine levels in different brands of commercially available guaraná powder. METHODS: The analytical methodology involved extraction with water, clean-up with saturated basic lead acetate solution and determination by high performance liquid chromatography with diode array detector (200-400nm). 39 samples were purchased in the cities of Campinas and Ribeirão Preto, SP, between December 2003 and January 2004 and analyzed. RESULTS: The caffeine levels in the samples varied widely ranging from 9.52 to 36.71mg/g, probably due to differences in the origin of the raw material and to the types of processing that the guaraná seeds are submitted to. In comparison to coffee, traditional source of caffeine in the diet, it is possible to verify that the average caffeine content in guaraná powder is about four times higher than the quantities present in coffee. CONCLUSION: Among guaraná powder consumers, this product may be considered as an important source of caffeine in the diet. The association with other products containing caffeine suggests that the guaraná powder consumption should be controlled as the debate regarding caffeine's safe dose of intake remains.