The aim of this paper is to report insights from the first 100 consecutive cardiovascular procedures with MANTA closure.
The collagen-based MANTA vascular closure device (Teleflex, Wayne, ...Pennsylvania) has recently been approved for the closure of large-bore femoral access.
Procedural and access site–related complications were analyzed according to Valve Academic Research Consortium–2 criteria. Duration of bleeding after device closure was recorded.
Patients underwent transcatheter aortic valve replacement (n = 75), endovascular aortic replacement (n = 21), or Impella left ventricular support (n = 4). In these 100 patients, a total of 122 MANTA devices were used (22 patients had bilateral large-bore access). None of the patients received protamine. Immediate hemostasis was achieved in 70 patients and hemostasis within 5 min in 87 patients. There were 7 patients with major and 4 patients with minor MANTA-associated vascular complications: femoral artery occlusion in 2, ongoing bleeding in 5, and pseudoaneurysm formation in 4 patients. One patient was treated with covered stent implantation, 7 required surgical revision, and 4 received thrombin injection. Complications occurred significantly more often in patients with peripheral artery disease and a minimal artery diameter <6 mm. Careful review of these complications suggests 3 distinct failure mechanisms. In vessels with narrow femoral artery diameters, elevation of the toggle may lead to occlusion of the artery, incomplete apposition of the plug may lead to perivascular (potentially retroperitoneal) bleeding, or pseudoaneurysm formation may occur.
In this paper, MANTA-associated complications are addressed, 3 distinct failure mechanisms are suggested, and strategies to avoid these complications and improve procedural outcomes are discussed.
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Abstract
Aims
We aimed to evaluate the frequency, clinical features, and prognostic implications of cardiac arrest (CA) in takotsubo syndrome (TTS).
Methods and results
We reviewed the records of ...patients with CA and known heart rhythm from the International Takotsubo Registry. The main outcomes were 60-day and 5-year mortality. In addition, predictors of mortality and predictors of CA during the acute TTS phase were assessed. Of 2098 patients, 103 patients with CA and known heart rhythm during CA were included. Compared with patients without CA, CA patients were more likely to be younger, male, and have apical TTS, atrial fibrillation (AF), neurologic comorbidities, physical triggers, and longer corrected QT-interval and lower left ventricular ejection fraction on admission. In all, 57.1% of patients with CA at admission had ventricular fibrillation/tachycardia, while 73.7% of patients with CA in the acute phase had asystole/pulseless electrical activity. Patients with CA showed higher 60-day (40.3% vs. 4.0%, P < 0.001) and 5-year mortality (68.9% vs. 16.7%, P < 0.001) than patients without CA. T-wave inversion and intracranial haemorrhage were independently associated with higher 60-day mortality after CA, whereas female gender was associated with lower 60-day mortality. In the acute phase, CA occurred less frequently in females and more frequently in patients with AF, ST-segment elevation, and higher C-reactive protein on admission.
Conclusions
Cardiac arrest is relatively frequent in TTS and is associated with higher short- and long-term mortality. Clinical and electrocardiographic parameters independently predicted mortality after CA.
Little is known about heart diseases and their treatment in rural sub-Saharan Africa. This study aimed to describe the occurrence, characteristics, and etiologies of heart diseases, and the ...medication taken before and prescribed after echocardiography in a rural referral Hospital in Tanzania.
This prospective descriptive cohort study included all adults and children referred for echocardiography. Clinical and echocardiographic data were collated for analysis.
From December 2015 to October 2017, a total of 1'243 echocardiograms were performed. A total of 815 adults and 59 children ≤15 years had abnormal echocardiographic findings; in adults 537/815 (66%) had hypertension, with 230/537(43%) on antihypertensive drugs, and 506/815 (62%) were not on regular cardiac medication; 346/815 (42%) had severe eccentric or concentric left ventricular hypertrophy, and 182/815 (22%) had severe systolic heart failure. Only 44% demonstrated normal left ventricular systolic function. The most frequent heart diseases were hypertensive heart disease (41%), valvular heart disease (18%), coronary heart disease (18%), peripartum cardiomyopathy (7%), and other non-hypertensive dilated cardiomyopathies (6%) in adults, and congenital heart disease (34%) in children. Following echocardiography, 802/815 (98%) adults and 40/59 (68%) children had an indication for cardiac medication, 70/815 (9%) and 2/59 (3%) for oral anticoagulation, and 35/815 (4%) and 23/59 (39%) for cardiac surgery, respectively.
Hypertension is the leading etiology of heart diseases in rural Tanzania. Most patients present with advanced stages of heart disease, and the majority are not treated before echocardiography. There is an urgent need for increased awareness, expertise and infrastructure to detect and treat hypertension and heart failure in rural Africa.
Abstract Objectives The study sought to identify predictors for delayed high-degree atrioventricular block (AVB) in patients undergoing transcatheter aortic valve replacement (TAVR) and determine the ...need and required duration of telemetry monitoring. Background Little is known about predictors and timing of high-degree AVB. Methods A total of 1,064 patients (52% women) without a permanent pacemaker undergoing TAVR at 3 centers in Switzerland were investigated. Electrocardiograms (ECGs) at baseline and post-TAVR were analyzed to identify atrioventricular and interventricular conduction disorders. Results Periprocedural high-degree AVB occurred in 92 (8.7%), delayed high-degree AVB in 71 (6.7%), up to 8 days post-procedure. In multivariate analysis, delayed high-degree AVB occurred more frequently in men (odds ratio: 2.4, 95% confidence interval: 1.3 to 4.5; p < 0.01), and in patients with conduction disorders post-TAVR (odds ratio: 10.8; 95% confidence interval: 4.6 to 25.5; p < 0.01). Patients in sinus rhythm without conduction disorders post-TAVR did not develop delayed high-degree AVB (0 of 250, 0%). Similarly, the risk in patients with atrial fibrillation but no other conduction disorders was very low (1 of 102, 1%). There was no patient developing delayed high-degree AVB who had a stable ECG for 2 days or more. Conclusion Patients without conduction disorders post-TAVR did not develop delayed high-degree AVB. Such patients may not require telemetry monitoring. All other patients should be monitored until the ECG remains stable for at least 2 days. This algorithm should be validated in a separate patient population.
This study aimed to analyse health related quality of life (HRQoL) for patients with different atrial fibrillation (AF) types and to identify patient characteristics, symptoms and comorbidities that ...influence HRQoL.
We used baseline data from the Swiss Atrial Fibrillation (Swiss-AF) study, a prospective multicentre observational cohort study conducted in 13 clinical centres in Switzerland. Between April 2014 and August 2017, 2415 AF patients were recruited. Patients were included in this analysis if they had baseline HRQoL data as assessed with EQ-5D-based utilities and visual analogue scale (VAS) scores. Patient characteristics and HRQoL were described stratified by AF type. The impact of symptoms, comorbidities and socio-economic factors on HRQoL was analysed using multivariable regression analysis.
Based on 2412 patients with available baseline HRQoL data, the lowest unadjusted mean HRQoL was found in patients with permanent AF regardless of whether measured with utilities (paroxysmal: 0.83, persistent: 0.84, permanent: 0.80, p<0.001) or VAS score (paroxysmal: 73.6, persistent: 72.8, permanent: 69.2, p<0.001). In multivariable analysis of utilities and VAS scores, higher European Heart Rhythm Association (EHRA) score, recurrent falls and several comorbidities showed a strong negative impact on HRQoL while AF type was no longer associated with HRQoL.
Multiple factors turned out to influence HRQoL in AF patients. After controlling for several comorbidities, the EHRA score was one of the strongest predictors independent of AF type. The results may be valuable for better patient assessment and provide a reference point for further QoL and health economic analyses in AF populations.
Background Inflammation plays a pivotal role in coronary artery disease (CAD). The anti‐inflammatory drug colchicine seems to reduce ischemic events in patients with CAD. So far there is equipoise ...about its safety and impact on mortality. Methods and Results To evaluate the utility of colchicine in patients with acute and chronic CAD, we performed a systematic review and meta‐analysis. MEDLINE, EMBASE, Cochrane CENTRAL and conference abstracts were searched from January 1975 to October 2020. Randomized trials assessing colchicine compared with placebo/standard therapy in patients with CAD were included. Data were combined using random‐effects models. The reliability of the available data was tested using trial sequential analyses . Of 3108 citations, 13 randomized trials (n=13 125) were included. Colchicine versus placebo/standard therapy in patients with CAD reduced risk of myocardial infarction (odds ratio OR 0.64; 95% CI, 0.46–0.90; P =0.01; I 2 41%) and stroke/transient ischemic attack (OR 0.50; 95% CI, 0.31–0.81; P =0.005; I 2 0%). But treatment with colchicine compared with placebo/standard therapy had no influence on all‐cause and cardiovascular mortality (OR 0.96; 95% CI, 0.65–1.41; P =0.83; I 2 24%; and OR 0.82; 95% CI, 0.55–1.22; P =0.45; I 2 0%, respectively). Colchicine increased the risk for gastrointestinal side effects ( P <0.001). According to trial sequential analyses, there is only sufficient evidence for a myocardial infarction risk reduction with colchicine. Conclusions Among patients with CAD, colchicine reduces the risk of myocardial infarction and stroke, but has a higher rate of gastrointestinal upset with no influence on all‐cause mortality.
Abstract
To compare the safety and efficacy of manual compression versus use of the MANTA closure device for access management after Impella removal on the intensive care unit (ICU). The number of ...patients treated with percutaneous left ventricular assist devices (pLVAD), namely Impella and ECMO, for complex cardiac procedures or shock, is growing. However, removal of pLVAD and large bore arteriotomy closure among such patients on the ICU remains challenging, since it is associated with a high risk for bleeding and vascular complications. Patients included in a prospective registry between 2017 and 2020 were analyzed. Bleeding and vascular access site complications were assessed and adjudicated according to VARC-2 criteria. We analyzed a cohort of 87 consecutive patients, who underwent access closure after Impella removal on ICU by using either the MANTA device or manual compression. The cohort´s mean age was 66.1 ± 10.7 years and 76 patients (87%) were recovering from CS. Mean support time was 40 h (interquartile range 24–69 h). MANTA was used in 31 patients (35.6%) and manual compression was applied in 56 patients (64.4%). Overall access related bleedings were significantly lower in the MANTA group (6.5% versus 39.3% (odds ratio (OR) 0.10, 95% CI 0.01–0.50;
p
= 0.001), and there was no significant difference in vascular complications between the two groups (
p
= 0.55). Our data suggests that the application of the MANTA device directly on the ICU is safe. In addition, it seems to reduce access related bleeding without increasing the risk of vascular complications.
Aims
The aim of the present study was to investigate the impact of aspirin on prognosis in takotsubo syndrome (TTS).
Methods and results
Patients from the International Takotsubo (InterTAK) Registry ...were categorized into two groups based on aspirin prescription at discharge. A comparison of clinical outcomes between groups was performed using an adjusted analysis with propensity score (PS) stratification; results from the unadjusted analysis were also reported to note the effect of the PS adjustment. Major adverse cardiac and cerebrovascular events (MACCE: a composite of death, myocardial infarction, TTS recurrence, stroke or transient ischaemic attack) were assessed at 30‐day and 5‐year follow‐up. A total of 1533 TTS patients with known status regarding aspirin prescription at discharge were included. According to the adjusted analysis based on PS stratification, aspirin was not associated with a lower hazard of MACCE at 30‐day hazard ratio (HR) 1.24, 95% confidence interval (CI) 0.50–3.04, P = 0.64 or 5‐year follow‐up (HR 1.11, 95% CI 0.78–1.58, P = 0.58). These results were confirmed by sensitivity analyses performed with alternative PS‐based methods, i.e. covariate adjustment and inverse probability of treatment weighting.
Conclusion
In the present study, no association was found between aspirin use in TTS patients and a reduced risk of MACCE at 30‐day and 5‐year follow‐up. These findings should be confirmed in adequately powered randomized controlled trials.
ClinicalTrials.gov Identifier: NCT01947621.
Background: In the last decade, newer generation ICD leads have been developed based on mechanistic insides of priorly failing leads. The aim of our study was to assess the long-term performance and ...mechanisms of failure of the 2013-introduced Biotronik Protego ICD lead in a real-world population. Methods: All patients, who underwent implantation of a Protego ICD lead at the Heart Centre Lucerne (Lucerne, Switzerland) between November 2013 and March 2017, were followed up with semi-annual device-controls. The primary endpoint was defined as lead failure, secondary endpoints compromised all-cause death, (in)appropriate shocks and the need for reintervention. Results: A total of 64 patients (mean age 66.7 ± 8.7 years, 30% female) underwent implantation of a Protego ICD lead: 78% for primary prevention, 53% had underlying ischemic heart disease, and 40.6% had a dilated cardiomyopathy (DCM). Mean left ventricular ejection fraction (LVEF) was 32.6 ± 10.5%. A total of 24 patients were treated with cardiac resynchronization therapy (CRT), and their baseline LVEF improved from 27.8 ± 7.3% before to 39.8 ± 12.5 after implantation (p < 0.001). Mean time to follow-up was 5.5 ± 0.9 years. Overall, 14 patients (26.6%) suffered from at least one episode of sustained ventricular tachycardia; in total 10 patients (15.6%) died. Two patients experienced lead failure due to lead fracture after 5.5 and 5.7 years, which was clinically apparent by an abrupt rise in lead impedance (>2000 Ω) and by repetitive inappropriate shocks, respectively. Conclusions: In this retrospective observational study, the calculated annual lead failure rate of the Biotronik Protego ICD lead was 0.59% per patient—thus, the durability and long-term performance seem to be promising.
Background Previous reports have described a leveling off of mortality from premature coronary artery disease (CAD). In recent years, the prevalence of cardiovascular risk factors has increased in ...rural communities and young adults. Methods and Results We extracted CAD mortality rates from the Centers for Disease Control and Prevention Wide-Ranging Online Data for Epidemiologic Research (CDC WONDER) database from 1999 to 2017, focusing on mortality from premature CAD (defined as <65 years of age in women) and urban-rural differences. Variations in mortality rates over time, assessed with Joinpoint regression modeling, are expressed as estimated annual percentage change (95% CI) and stratified by urbanization, sex, age, and race. Age-adjusted mortality rates decreased for women and men. Stratification by urbanization revealed that premature CAD mortality is stagnating among women in rural areas. However, this stagnation conceals a statistically significant increase in CAD mortality rates since 2009 in women aged 55 to 64 years (estimated annual percentage change: +1.4%; 95% CI, +0.3% to +2.5%) and since 1999 in women aged 45 to 54 years (estimated annual percentage change: +0.6%; 95% CI, +0.2% to 1.0%). Since 1999, mortality has been stagnating in the youngest group (aged 35-44 years; estimated annual percentage change: +0.2%; 95% CI, -0.4% to +0.8%). Stratification by race indicated an increase in mortality rates among white rural women. Premature CAD mortality remains consistently higher in the rural versus urban United States, regardless of sex, race, and age group. Conclusions Premature CAD mortality rates have declined over time. However, stratification by sex and urbanization reveals disparities that would otherwise remain concealed: CAD mortality rates have increased among women from rural areas since at least 2009.
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