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This study investigated the long-term effects of humidified high-flow nasal cannula (HFNC) in COPD patients with chronic hypoxemic respiratory failure treated with long-term oxygen therapy (LTOT). A total of 200 patients were randomized into usual care ± HFNC. At inclusion, acute exacerbation of COPD (AECOPD) and hospital admissions 1 year before inclusion, modified Medical Research Council (mMRC) score, St George's Respiratory Questionnaire (SGRQ), forced expiratory volume in 1 second (FEV ), 6-minute walk test (6MWT) and arterial carbon dioxide (PaCO ) were recorded. Patients completed phone interviews at 1, 3 and 9 months assessing mMRC score and AECOPD since the last contact. At on-site visits (6 and 12 months), mMRC, number of AECOPD since last contact and SGRQ were registered and FEV , FEV %, PaCO and, at 12 months, 6MWT were reassessed. Hospital admissions during the study period were obtained from hospital records. Hours of the use of HFNC were retrieved from the high-flow device. The average daily use of HFNC was 6 hours/day. The HFNC group had a lower AECOPD rate (3.12 versus 4.95/patient/year, <0.001). Modeled hospital admission rates were 0.79 versus 1.39/patient/year for 12- versus 1-month use of HFNC, respectively ( <0.001). The HFNC group had improved mMRC scores from 3 months onward ( <0.001) and improved SGRQ at 6 and 12 months ( =0.002, =0.033) and PaCO ( =0.005) and 6MWT ( =0.005) at 12 months. There was no difference in all-cause mortality. HFNC treatment reduced AECOPD, hospital admissions and symptoms in COPD patients with hypoxic failure.

Background Infected necrosis complicates 10% of all acute pancreatitis episodes and is associated with 15–20% mortality. The current standard treatment for infected necrotizing pancreatitis is the step-up approach (catheter drainage, followed, if necessary, by minimally invasive necrosectomy). Catheter drainage is preferably postponed until the stage of walled-off necrosis, which usually takes 4 weeks. This delay stems from the time when open necrosectomy was the standard. It is unclear whether such delay is needed for catheter drainage or whether earlier intervention could actually be beneficial in the current step-up approach. The POINTER trial investigates if immediate catheter drainage in patients with infected necrotizing pancreatitis is superior to the current practice of postponed intervention. Methods POINTER is a randomized controlled multicenter superiority trial. All patients with necrotizing pancreatitis are screened for eligibility. In total, 104 adult patients with (suspected) infected necrotizing pancreatitis will be randomized to immediate (within 24 h) catheter drainage or current standard care involving postponed catheter drainage. Necrosectomy, if necessary, is preferably postponed until the stage of walled-off necrosis, in both treatment arms. The primary outcome is the Comprehensive Complication Index (CCI), which covers all complications between randomization and 6-month follow up. Secondary outcomes include mortality, complications, number of (repeat) interventions, hospital and intensive care unit (ICU) lengths of stay, quality-adjusted life years (QALYs) and direct and indirect costs. Standard follow-up is at 3 and 6 months after randomization. Discussion The POINTER trial investigates if immediate catheter drainage in infected necrotizing pancreatitis reduces the composite endpoint of complications, as compared with the current standard treatment strategy involving delay of intervention until the stage of walled-off necrosis. Trial registration ISRCTN, 33682933 . Registered on 6 August 2015. Retrospectively registered.

Background Degenerative aortic valve (AV) stenosis is the most prevalent heart valve disease in the western world. Surgical aortic valve replacement (SAVR) has until recently been the standard of treatment for patients with severe AV stenosis. Whether transcatheter aortic valve implantation (TAVI) can be offered with improved safety and similar effectiveness in a population including low-risk patients has yet to be examined in a randomised setting. Methods/Design This randomised clinical trial will evaluate the benefits and risks of TAVI using the transarterial CoreValve System (Medtronic Inc., Minneapolis, MN, USA) (intervention group) compared with SAVR (control group) in patients with severe degenerative AV stenosis. Randomisation ratio is 1:1, enrolling a total of 280 patients aged 70 years or older without significant coronary artery disease and with a low, moderate, or high surgical risk profile. Trial outcomes include a primary composite outcome of myocardial infarction, stroke, or all-cause mortality within the first year after intervention (expected rates 5% for TAVI, 15% for SAVR). Exploratory safety outcomes include procedure complications, valve re-intervention, and cardiovascular death, as well as cardiac, cerebral, pulmonary, renal, and vascular complications. Exploratory efficacy outcomes include New York Heart Association functional status, quality of life, and valve prosthesis and cardiac performance. Enrolment began in December 2009, and 269 patients have been enrolled up to December 2012. Discussion The trial is designed to evaluate the performance of TAVI in comparison with SAVR. The trial results may influence the choice of treatment modality for patients with severe degenerative AV stenosis. Trial registration ClinicalTrials.gov: NCT01057173

Background Conduction disorders and permanent pacemaker (PPM) implantation are common complications in patients undergoing transcatheter aortic valve implantation (TAVI). Previous studies, evaluating small populations, have identified several different predictors of PPM implantation after TAVI. The aim of this study was to assess the incidence rate of conduction disorders and the predictors of postoperative PPM requirement in a large series of patients undergoing TAVI. Methods Data were analyzed from 181 consecutive patients at high-risk surgery who underwent TAVI at our institute between July 2007 and April 2011. All patients underwent implantation of the third-generation percutaneous self-expanding CoreValve® prosthesis (CoreValve, Inc., Irvine, CA, USA). In all patients, a 12-lead electrocardiogram and a 24-h holter monitoring was recorded before and after the procedure in order to assess the presence of conduction disorders. Clinical data, preoperative conduction disorders, echocardiographic patterns, and procedural data were tested as predictors of PPM implantation after TAVI. Results Left bundle branch block (LBBB) was the most common conduction disorder, with an incidence of 50.3% at discharge. Fifty-two (32.1%) patients developed a persistent complete AVB requiring PPM implantation. PPM implantation was strongly correlated with the presence of preoperative right bundle branch block (RBBB) which was found to be the only independent predictor of PPM implantation (HR 16.5, CI 3.3–82.3, p  < 0.001). Conclusions LBBB and PPM implantation requirement after TAVI are common occurrences using the self-expanding CoreValve prosthesis. In this large series of consecutive patients, only RBBB was found to be a strong predictor of PPM requirement.

Background and Purpose: Transcatheter aortic valve implantation (TAVI) is a rapidly emerging treatment option for patients with aortic valve stenosis and high surgical risk. Different access routes have been proposed for TAVI including transapical, transsubclavian and transfemoral, with percutaneous transfemoral being the preferred because least invasive and nonsurgical. However, vascular access site complications due to the large-bore delivery catheters remain an important clinical issue, particularly with respect to the elderly patient collective typically considered for TAVI. In the study, the authors analyzed their 4-year TAVI experience with respect to vascular complications and their management in patients undergoing completely percutaneous transfemoral TAVI procedures. Patients and Methods: Since 2006, TAVI was performed in 101 consecutive patients at the West German Heart Center Essen. 33 patients underwent transapical TAVI, eight patients transfemoral TAVI with surgical access or closure, and 60 patients percutaneous transfemoral TAVI using two commercially available prosthetic valve devices. Results: Completely percutaneous TAVI was technically successful in all but one patient with malpositioning in the aortic arch during valve retrieval. There was no intraprocedural death and 30-day mortality was 12% (7/60). Vascular access site complications occurred in 19 patients (32%), necessitating surgical repair in six of them (10%). Complications included retroperitoneal hematoma (n = 2), iliac or femoral artery dissection (n = 10), (pseudo)aneurysm formation (n = 3), and closure device-induced vessel stenosis/ occlusion (n = 6). Of these, 13 cases could be managed either conservatively (n = 5) or by contralateral endovascular treatment (n = 8). Conclusion: Completely percutaneous TAVI has a high acute success rate with low intraprocedural and 30-day mortality. The patient collective appears to be prone to vascular complications which remain an important limitation of this novel technique. Although conservative or endovascular management is possible in the majority of cases, further technological developments are obliged to reduce the vascular complication rate.

Background:Data comparing survival outcomes for women versus men transported for pPCI were absent.Objectives:To assess the impact of gender on 30-day mortality of patients with STEMI transported for pPCI.Methods:The data from the PRAGUE-1 and PRAGUE-2 trials were analysed. Studies compared thrombolysis in the community hospital and pPCI after transportation to cardiocentre. A group of 520 patients treated with thrombolysis, and 530 transported for pPCI, were analysed.Results:Women were older, with a higher risk profile. They had longer ischaemia time. Mortality of patients treated with TL was significantly higher in women than in men (15% vs 9%, p = 0.043). There was no significant gender difference in mortality in the PCI group (8.2% of women vs 6.2% of men, p = 0.409). Mortality of women treated with on-site TL was nearly twice as high as mortality of women transported for pPCI (p = 0.043). After adjustment in a multivariate model the odds ratio for mortality in women was 0.74 (95% CI 0.26 to 2.05; p = 0.556).Conclusion:Long-distance transportation of women with STEMI from a community hospital to a tertiary PCI centre is a significantly more effective treatment strategy than on-site TL. Gender did not determine survival in patients transported for pPCI.

Objective Decision making for intervention in symptomatic aortic stenosis should balance the risks of surgery and of transcatheter aortic valve implantation (TAVI). We identified the factors associated with early mortality after TAVI and aimed to develop and validate a simple risk score. Methods A population of 3833 consecutive patients was randomly split into two cohorts comprising 2552 and 1281 patients, used respectively to develop and validate a scoring system predicting 30-day or in-hospital mortality. Results TAVI was performed using the Edwards Sapien prosthesis in 2551 (66.8%) patients and the Medtronic Corevalve in 1270 (33.2%). Approach was transfemoral in 2801 (73.4%) patients, transapical in 678 (17.8%), subclavian in 219 (5.7%) and other in 117 (3.1%). Early mortality was 10.0% (382 patients). A multivariate logistic model identified the following predictive factors of early mortality: age ≥90 years, body mass index <30 Kg/m2, New York Heart Association class IV, pulmonary hypertension, critical haemodynamic state, ≥2 pulmonary oedemas during the last year, respiratory insufficiency, dialysis and transapical or other (transaortic and transcarotid) approaches. A 21-point predictive score was derived. C-index was 0.67 for the score in the development cohort and 0.59 in the validation cohort. There was a good concordance between predicted and observed 30-day mortality rates in the development and validation cohorts. Conclusions Early mortality after TAVI is mainly related to age, the severity of symptoms, comorbidities and transapical approach. A simple score can be used to predict early mortality after TAVI. The moderate discrimination is however a limitation for the accurate identification of high-risk patients.

Purpose Cryoballoon ablation of the pulmonary veins (CAPV) is a new technique that could have similar results to radiofrequency procedures, but with fewer complications. We analyzed the outcomes and safety of this technique in a consecutive cohort of patients with atrial fibrillation (AF). Methods A total of 63 patients with paroxysmal ( n  = 40) or persistent ( n  = 23) AF were studied. Patient follow-up was performed at 3 months and then every 6 months with 72-h continuous electrocardiographic recordings. Results A total of 262 pulmonary veins were treated; 60.3 % of the cases presented normal pulmonary vein drainage with 4 pulmonary veins, and 23.8 % of the cases presented a common left-sided antrum. Complete isolation of all veins was achieved in 95.2 % of cases with 10.3 ± 2.8 (mean ± standard deviation) applications per patient. Transient right phrenic nerve injury was the most common complication (4.7 %). Median follow-up was 5.5 months. The probability of being free of recurrence at 1 and 2 years was, respectively, 86.2 and 72.2 % for paroxysmal AF and 49 and 36.4 % for persistent AF ( P  = 0.012). Patients with structural heart disease experienced recurrence more often than patients with a normal heart (62.5 versus 24.5 %; P  = 0.03). Conclusions CAPV appears to be a safe and effective procedure for the treatment of patients with AF, particularly those with paroxysmal AF and no structural heart disease.

AimsDuring the COVID-19 pandemic, hospital admissions for cardiac care have declined. However, effects on mortality are unclear. Thus, we sought to evaluate the impact of the lockdown period in central Germany on overall and cardiovascular deaths. Simultaneously we looked at catheterization activities in the same region.Methods and resultsData from 22 of 24 public health-authorities in central Germany were aggregated during the pandemic related lockdown period and compared to the same time period in 2019. Information on the total number of deaths and causes of death, including cardiovascular mortality, were collected. Additionally, we compared rates of hospitalization (n = 5178) for chronic coronary syndrome (CCS), acute coronary syndrome (ACS), and out of hospital cardiac arrest (OHCA) in 26 hospitals in this area. Data on 5,984 deaths occurring between March 23, 2020 and April 26, 2020 were evaluated. In comparison to the reference non-pandemic period in 2019 (deaths: n = 5832), there was a non-significant increase in all-cause mortality of 2.6% [incidence rate ratio (IRR) 1.03, 95% confidence interval (CI) 0.99–1.06; p = 0.16]. Cardiovascular and cardiac mortality increased significantly by 7.6% (IRR 1.08, 95%-CI 1.01–1.14; p = 0.02) and by 11.8% (IRR 1.12, 95%-CI 1.05–1.19; p < 0.001), respectively. During the same period, our data revealed a drop in cardiac catherization procedures.ConclusionDuring the COVID-19-related lockdown a significant increase in cardiovascular mortality was observed in central Germany, whereas catherization activities were reduced. The mechanisms underlying both of these observations should be investigated further in order to better understand the effects of a pandemic-related lockdown and social-distancing restrictions on cardiovascular care and mortality.Graphic abstract

ObjectivesMitral regurgitation (MR) is a common entity in patients with aortic stenosis undergoing transcatheter aortic valve replacement (TAVR), but its influence on outcomes remains controversial. The purpose of this meta-analysis was to assess the clinical impact of and changes in significant (moderate–severe) MR in patients undergoing TAVR, overall and according to valve design (self-expandable (SEV) vs balloon-expandable (BEV)).MethodsAll national registries and randomised trials were pooled using meta-analytical guidelines to establish the impact of moderate–severe MR on mortality after TAVR. Studies reporting changes in MR after TAVR on an individual level were electronically searched and used for the analysis.ResultsEight studies including 8015 patients (SEV: 3474 patients; BEV: 4492 patients) were included in the analysis. The overall 30-day and 1-year mortality was increased in patients with significant MR (OR 1.49, 95% CI 1.16 to 1.92; HR 1.32, 95% CI 1.12 to 1.55, respectively), but a significant heterogeneity across studies was observed (p<0.05). The impact of MR on mortality was not different between SEV and BEV in meta-regression analysis for 30-day (p=0.360) and 1-year (p=0.388) mortality. Changes in MR over time were evaluated in nine studies including 1278 patients. Moderate–severe MR (SEV: 326 patients; BEV: 192 patients) improved in 50.5% of the patients at a median follow-up of 180 (30–360) days after TAVR, and the degree of improvement was greater in patients who had received a BEV (66.7% vs 40.8% in the SEV group, p=0.001).ConclusionsConcomitant moderate–severe MR was associated with increased early and late mortality following TAVR. A significant improvement in MR severity was detected in half of the patients following TAVR, and the degree of improvement was greater in those patients who had received a BEV.