The natural history of QTc interval and its clinical impact in coronavirus disease 2019 survivors after 1 year

Background and objectiveProlonged QTc interval on admission and a higher risk of death in SARS-CoV-2 patients have been reported. The long-term clinical impact of prolonged QTc interval is unknown. This study examined the relationship in COVID-19 survivors of a prolonged QTc on admission with long-term adverse events, changes in QTc duration and its impact on 1-year prognosis, and factors associated with a prolonged QTc at follow-up.MethodsWe conducted a single-center prospective cohort study of 523 SARS-CoV-2-positive patients who were alive on discharge. An electrocardiogram was taken on these patients within the first 48 h after diagnosis and before the administration of any medication with a known effect on QT interval and repeated in 421 patients 7 months after discharge. Mortality, hospital readmission, and new arrhythmia rates 1 year after discharge were reviewed.ResultsThirty-one (6.3%) survivors had a baseline prolonged QTc. They were older, had more cardiovascular risk factors, cardiac disease, and comorbidities, and higher levels of terminal pro-brain natriuretic peptide. There was no relationship between prolonged QTc on admission and the 1-year endpoint (9.8% vs. 5.5%, p = 0.212). In 84% of survivors with prolonged baseline QTc, it normalized at 7.9 ± 2.2 months. Of the survivors, 2.4% had prolonged QTc at follow-up, and this was independently associated with obesity, ischemic cardiomyopathy, chronic obstructive pulmonary disease, and cancer. Prolonged baseline QTc was not independently associated with the composite adverse event at 1 year.ConclusionsProlonged QTc in the acute phase normalized in most COVID-19 survivors and had no clinical long-term impact. Prolonged QTc at follow-up was related to the presence of obesity and previously acquired chronic diseases and was not related to 1-year prognosis

Socioeconomic Status and Prognosis of Patients With ST-Elevation Myocardial Infarction Managed by the Emergency-Intervention “Codi IAM” Network

Inequalities; Mortality; Primary percutaneous coronary interventionDesigualdades; Mortalidad; Intervención coronaria percutánea primariaDesigualtats; Mortalitat; Intervenció coronària percutània primàriaBackground: Despite the spread of ST-elevation myocardial infarction (STEMI) emergency intervention networks, inequalities in healthcare access still have a negative impact on cardiovascular prognosis. The Family Income Ratio of Barcelona (FIRB) is a socioeconomic status (SES) indicator that is annually calculated. Our aim was to evaluate whether SES had an effect on mortality and complications in patients managed by the “Codi IAM” network in Barcelona. Methods: This is a cohort study with 3,322 consecutive patients with STEMI treated in Barcelona from 2010 to 2016. Collected data include treatment delays, clinical and risk factor characteristics, and SES. The patients were assigned to three SES groups according to FIRB score. A logistic regression analysis was conducted to estimate the adjusted effect of SES on 30-day mortality, 30-day composite cardiovascular end point, and 1-year mortality. Results: The mean age of the patients was 65 ± 13% years, 25% were women, and 21% had diabetes mellitus. Patients with low SES were younger, more often hypertensive, diabetic, dyslipidemic (p < 0.003), had longer reperfusion delays (p < 0.03) compared to participants with higher SES. Low SES was not independently associated with 30-day mortality (OR: 0.95;9 5% CI: 0.7–1.3), 30-day cardiovascular composite end point (OR: 1.03; 95% CI: 0.84–1.26), or 1-year all-cause mortality (HR: 1.09; 95% CI: 0.76–1.56). Conclusion: Although the low-SES patients with STEMI in Barcelona city were younger, had worse clinical profiles, and had longer revascularization delays, their 30-day and 1-year outcomes were comparable to those of the higher-SES patients.This project was supported by the CIBERCV of research on cardiovascular diseases personnel hired with its resources

Very long-term efficacy and safety of paclitaxel-eluting balloon after a bare-metal stent for the treatment of ST-elevation myocardial infarction: 8-year results of a randomized clinical trial (PEBSI study)

Drug-eluting stents; Drug-coated balloons; Myocardial infarctionStents alliberadors de fàrmacs; Globus recoberts de fàrmacs; Infart de miocardiStents liberadores de fármacos; Globos recubiertos de fármacos; Infarto de miocardioBackground: Drug-eluting stents (DES) are considered the therapy of choice in ST-segment elevation myocardial infarction (STEMI); however, a low persistent rate of revascularizations and stent thrombosis exist over the time. We have previously shown that a paclitaxel (PTX)-drug-coated balloon (DCB) after a bare-metal stent (BMS) implantation (DCB-combined strategy) yields superior angiographic and clinical results compared to BMS in the short term. However, the long-term safety and efficacy of this approach remain uncertain. Methods: An 8-year clinical follow-up was conducted on patients enrolled in the randomized PEBSI-1 trial (NCT01839890). The original trial included patients who suffered a STEMI, patients were randomly assigned to receive a DCB-combined strategy or BMS only and the primary endpoint was in-stent late luminal loss (LLL) at 9-month follow-up. After the completion of this study, death, myocardial re-infarction, ischemia-driven repeated revascularizations included target lesion revascularization (TLR) and target vessel revascularization (TVR), and stent thrombosis, were assessed by yearly contact by a clinical visit, telephone or by electronic records. These outcomes were adhered to ARC-2 criteria. Results: The rate of incomplete follow-up was very low, with only 3 out of 111 patients (2.7%) in the DCB-combined strategy group and 1 out of 112 patients (0.9%) in the BMS group. At 8 years there were a lower rate of TVR [3.7% vs. 14.3%; hazard ratio (HR): 0.243; 95% confidence interval (CI): 0.081–0.727; P=0.006], and a trend towards lower TLR (2.8% vs. 8.9%; HR: 0.300; 95% CI: 0.083–1.090; P=0.052) in the DCB-combined strategy group. No statistical difference between the DCB-combined strategy and BMS groups were found for all causes of death, deaths from cardiovascular disease, reinfarctions or stent thrombosis. Notably in the DCB-combined strategy group, no episode of stent thrombosis occurred after the first year. Similarly, there were no cardiovascular deaths, TVR and TLR in the DCB-combined strategy group after 5 years. In contrast, during the period from year 5 to 8, the BMS group experienced an additional cardiovascular death, as well as one case of TVR, one case of TLR, and one case of stent thrombosis. Conclusions: In STEMI patients, the DCB-combined strategy maintains its safety and clinical efficacy over time. Our rates of TVR, TLR, and very late stent thrombosis (VLST) at very long-term are the lowest ever found in a STEMI trial. Further studies are warranted to assess the potential superiority of this novel strategy as compared with new-generation DES to prevent very late events in these patients. Trial Registration: ClinicalTrials.gov; identifier: NCT01839890.This investigation has received the support of the Spanish Clinical Research Network (SCReN), financed by the ISCIII-Subdirección General de Evaluación y Fomento de la Investigación, under the project PT13/0002/0005 (Plan Estatal de I+D+I 2013-2016) and co-funded by the European Regional Development Fund (FEDER). An unrestricted research grant was received from Biotronik

Treatment of small vessel disease with the paclitaxel drug-eluting balloon: 6-month angiographic and 1-year clinical outcomes of the Spanish multicenter registry

Background: small vessel disease (SMD) remains a major challenge because of the increased risk of restenosis. We sought to assess the efficacy and safety of a paclitaxel-eluting balloon (PEB) in patients with SMD. Methods and results: one-hundred and four patients with native coronary lesions in small vessels treated by using a PEB were included in this prospective multicenter registry. In each case, after regular balloon dilatation, a larger PEB was inflated for a minimum of 45-60 seconds. Patients were 65 ± 10 years old, 43% diabetic, and 58% presented acutely. Angiographic success was 93% (7% bailout BMS implantation due to coronary dissection). The rate of major adverse cardiac events (MACE) at 12 months was 4.8% (1.9% cardiac death, 1.0% MI, and 2.9% TLR). One definite stent thrombosis was reported at 6 months in a patient with bailout BMS implantation. At 7 months, late loss was 0.31 ± 0.2 mm. Bail-out BMS after DEB use, was an independent predictor of MACE, HR 18.74, 95%CI (2.58-135.84) and TLR, HR 30.99, 95%CI (2.79-344.07). Conclusion: the use of this PEB for the treatment of SMD provides excellent 1-year outcomes with only 4.8% MACE. The need for a bailout BMS was a strong predictor of MACE and TLR

Prolonged QT Interval in SARS-CoV-2 Infection: Prevalence and Prognosis

[EN] Background: The prognostic value of a prolonged QT interval in SARS-Cov2 infection is not well known. Objective: To determine whether the presence of a prolonged QT on admission is an independent factor for mortality in SARS-Cov2 hospitalized patients. Methods: Single-center cohort of 623 consecutive patients with positive polymerase-chain-reaction test (PCR) to SARS Cov2, recruited from 27 February to 7 April 2020. An electrocardiogram was taken on these patients within the first 48 h after diagnosis and before the administration of any medication with a known effect on QT interval. A prolonged QT interval was defined as a corrected QT (QTc) interval >480 milliseconds. Patients were followed up with until 10 May 2020. Results: Sixty-one patients (9.8%) had prolonged QTc and only 3.2% had a baseline QTc > 500 milliseconds. Patients with prolonged QTc were older, had more comorbidities, and higher levels of immune-inflammatory markers. There were no episodes of ventricular tachycardia or ventricular fibrillation during hospitalization. All-cause death was higher in patients with prolonged QTc (41.0% vs. 8.7%, p < 0.001, multivariable HR 2.68 (1.58–4.55), p < 0.001). Conclusions: Almost 10% of patients with COVID-19 infection have a prolonged QTc interval on admission. A prolonged QTc was independently associated with a higher mortality even after adjustment for age, comorbidities, and treatment with hydroxychloroquine and azithromycin. An electrocardiogram should be included on admission to identify high-risk SARS-CoV-2 patients.S

High rate of uncovered struts in latest generation drug-eluting stents with durable, biodegradable polymer or lack of it 1 month after implantation

Introduction and objectives: Delayed vascular healing may induce late stent thrombosis. Optical coherence tomography (OCT) is useful to evaluate endothelial coverage. The objective of this study was to compare stent coverage and apposition in non-complex coronary artery lesions treated with durable polymer-coated everolimus-eluting stents (durable-polymer EES) vs biodegradable polymer-coated everolimus-eluting stents ( biodegradable-polymer EES) vs polymer-free biolimus-eluting stents (BES) 1 and 6 months after stent implantation. Methods: Prospective, multicenter, non-randomized study that compared the 3 types of DES. Follow-up angiography and OCT were performed 1 and 6 months later. The primary endpoint was the rate of uncovered struts as assessed by the OCT at 1 month. Results: A total of 104 patients with de novo non-complex coronary artery lesions were enrolled. A total of 44 patients were treated with polymer-free BES, 35 with biodegradable-polymer EES, and 25 with durable-polymer EES. A high rate of uncovered struts was found at 1 month with no significant differences reported among the stents (80.2%, polymer-free BES; 88.1%, biodegradable-polymer EES; 82.5%, durable-polymer EES; P =.209). Coverage improved after 6 months in the 3 groups without significant differences being reported (97%, 95%, and 93.7%, respectively; P =.172). Conclusions: In patients with de novo non-complex coronary artery lesions treated with durable vs biodegradable vs polymer-free DES, strut coverage and apposition were suboptimal at 1 month with significant improvement at 6 months

Rationale and design of the Concordance study between FFR and iFR for the assessment of lesions in the left main coronary artery. The ILITRO-EPIC-07 Trial

Introduction and objectives: Patients with left main coronary artery (LMCA) stenosis have been excluded from the trials that support the non-inferiority of the instantaneous wave-free ratio (iFR) compared to the fractional flow reserve (FFR) in the decision-making process of coronary revascularization. This study proposes to prospectively assess the concordance between the two indices in LMCA lesions and to validate the iFR cut-off value of 0.89 for clinical use. Methods: National, prospective, and observational multicenter registry of 300 consecutive patients with intermediate lesions in the LMCA (angiographic stenosis, 25% to 60%. A pressure gudiewire study and determination of the RFF and the iFR will be performed: in the event of a negative concordant result (FFR > 0.80/iFR > 0.89), no treatment will be performed; in case of a positive concordant result (FFR 0.80/iFR 0.89), an intravascular echocardiography will be performed and revascularization will be delayed if the minimum lumen area is > 6 mm(2). The primary clinical endpoint will be a composite of cardiovascular death, LMCA lesion-related non-fatal infarction or need for revascularization of the LMCA lesion at 12 months. Conclusions: Confirm that an iFR-guided decision-making process in patients with intermediate LMCA stenosis is clinically safe and would have a significant clinical impact. Also, justify its systematic use when prescribing treatment in these potentially high-risk patients

Obstetric outcomes of sars-cov-2 infection in asymptomatic pregnant women

Altres ajuts: Fondo Europeo de Desarrollo Regional (FEDER)Around two percent of asymptomatic women in labor test positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in Spain. Families and care providers face childbirth with uncertainty. We determined if SARS-CoV-2 infection at delivery among asymptomatic mothers had different obstetric outcomes compared to negative patients. This was a multicenter prospective study based on universal antenatal screening for SARS-CoV-2 infection. A total of 42 hospitals tested women admitted for delivery using polymerase chain reaction, from March to May 2020. We included positive mothers and a sample of negative mothers asymptomatic throughout the antenatal period, with 6-week postpartum follow-up. Association between SARS-CoV-2 and obstetric outcomes was evaluated by multivariate logistic regression analyses. In total, 174 asymptomatic SARS-CoV-2 positive pregnancies were compared with 430 asymptomatic negative pregnancies. No differences were observed between both groups in key maternal and neonatal outcomes at delivery and follow-up, with the exception of prelabor rupture of membranes at term (adjusted odds ratio 1.88, 95% confidence interval 1.13-3.11; p = 0.015). Asymptomatic SARS-CoV-2 positive mothers have higher odds of prelabor rupture of membranes at term, without an increase in perinatal complications, compared to negative mothers. Pregnant women testing positive for SARS-CoV-2 at admission for delivery should be reassured by their healthcare workers in the absence of symptoms