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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Premature ventricular contractions (PVCs) are associated with an increased risk of morbidity and mortality. Therefore, it was aimed to assess risk factors for the frequency of PVCs in young and ...healthy adults.
Our population-based study included 2048 healthy adults from the general population aged 25-41 years. PVC frequency was determined by 24-hour Holter ECG. We performed multivariable regression analysis using stepwise backward selection to identify factors independently associated with PVC frequency.
Median age was 37 years, 953 (46.5%) were male. At least one PVC during the 24-hour monitoring period was observed in 69% of participants. Median number of detected PVCs was 2, the 95th percentile was 193. In multivariable regression analyses, we found 17 significant risk factors for PVC frequency. Low educational status (risk ratio (RR) 3.33; 95% CI 1.98 to 5.60), body height>median (1.58, 95% CI 1.11 to 2.24) and increasing levels of waist:hip ratio (2.15, 95% CI 1.77 to 2.61), N-terminal pro brain natriuretic peptide (1.52, 95% CI 1.30 to 1.76) and Sokolow-Lyon Index (1.38, 95% CI 1.15 to 1.66) (all p≤0.01) were associated with a higher PVC frequency. Physical activity (RR fourth vs first quartile 0.51, 95% CI 0.34 to 0.76) and increasing levels of haemoglobin (0.58, 95% CI 0.47 to 0.70) and glucagon-like peptide-1 (0.72, 95% CI 0.64 to 0.82) (all p<0.001) were related to a lower PVC frequency.
PVC occurrence is common even in healthy low-risk individuals, and its frequency is associated with several covariates mainly related to cardiovascular risk factors, markers of cardiac structure and function and socioeconomic status.
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.
Obstructive sleep apnea seems to have an important influence on the autonomic nervous system. In this study, we assessed the relations of sleep apnea–related parameters with 24-hour heart rate ...variability (HRV) in a large population of young and healthy adults. Participants aged 25 to 41 years with a body mass index <35 kg/m2 and without known obstructive sleep apnea were included in a prospective population-based cohort study. HRV was assessed using 24-hour electrocardiographic monitoring. The SD of all normal RR intervals (SDNN) was used as the main HRV variable. Apnea-Hypopnea Index (AHI) and oxygen desaturation index (ODI) were obtained from nighttime pulse oximetry with nasal airflow measurements. We defined sleep-related breathing disorders as an AHI ≥5 or an ODI ≥5. Multivariable regression models were constructed to assess the relation of HRV with either AHI or ODI. Median age of the 1,255 participants was 37 years, 47% were men, and 9.6% had an AHI ≥5. Linear inverse associations of SDNN across AHI and ODI groups were found (p for trend = 0.006 and 0.0004, respectively). The β coefficients (95% CI) for the relation between SDNN and elevated AHI were −0.20 (−0.40 to −0.11), p = 0.04 and −0.29 (−0.47 to −0.11), p = 0.002 for elevated ODI. After adjustment for 24-hour heart rate, the same β coefficients (95% CI) were −0.06 (−0.22 to 0.11), p = 0.51 and −0.14 (−0.30 to 0.01), p = 0.07, respectively. In conclusion, even early stages of sleep-related breathing disorders are inversely associated with HRV in young and healthy adults, suggesting that they are tightly linked with autonomic dysfunction. However, HRV and 24-hour heart rate seem to have common information.
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.
Chronic inflammatory disease (CID) accelerates atherosclerosis and the development of aortic stenosis. Data on long-term outcomes after transcatheter aortic valve implantation (TAVI) in those ...patients are missing. The aim of this study was to investigate the clinical long-term outcomes of patients with and without autoimmune-related CID undergoing TAVI for the treatment of severe aortic stenosis.
From a prospective registry, consecutive patients with TAVI were included. Baseline clinic and imaging data (echocardiographic and computed tomography) were analyzed. Long-term (up to 5 years) clinical and echocardiographic outcomes were studied. Of 1000 consecutive patients (mean age 81±6 years, 46% female), 107 (11%) had CID; the most frequent entities included polymyalgia rheumatica (31%) and rheumatoid arthritis (28%). Patients with CID were predominantly female (60% versus 44%,
=0.002) and more often had pulmonary disorders (21% versus 13%,
=0.046) and atrial fibrillation (32% versus 20%,
=0.003). The presence of CID was associated with a higher rate of postinterventional infection (5% versus 1%,
=0.007) and further emerged as a risk factor for rehospitalization for bleeding or infection (hazard ratio, 1.93 and 1.62, respectively). Premature valve degeneration, endocarditis, and all-cause mortality were not increased among patients with CID.
This real-world analysis found that patients with CID undergoing TAVI were associated with a higher risk of postinterventional infectious complications and rehospitalization due to infection. However, valve durability and survival seem not to differ between patients with TAVI with versus without CID.
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.
Abstract
Objectives
It is uncertain, if omitting post-dilatation and stent oversizing (stent optimization) is safe and may decrease the risk for distal thrombus embolization (DTE) in STEMI patients ...with large thrombus burden (LTB).
Background
In patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (pPCI) with stenting, (DTE) and flow deterioration are common and increase infarct size leading to worse outcomes.
Methods
From a prospective registry, 74 consecutive STEMI patients with LTB undergoing pPCI with stenting and intentionally deferred stent optimization were analyzed. Imaging data and outcomes up to 2 years follow-up were analyzed.
Results
Overall, 74 patients (18% females) underwent deferred stent optimization. Direct stenting was performed in 13 (18%) patients. No major complications occurred during pPCI. Staged stent optimization was performed after a median of 4 (interquartile range (IQR) 3; 7) days. On optical coherence tomography, under-expansion and residual thrombus were present in 59 (80%) and 27 (36%) cases, respectively. During deferred stent optimization, we encountered no case of flow deterioration (slow or no-reflow) or side branch occlusion. Minimal lumen area (mm
2
) and stent expansion (%) were corrected from 4.87±1.86mm to 6.82±2.36mm (
p
<0.05) and from 69±18% to 91±12% (
p
<0.001), respectively. During follow-up, 1 patient (1.4%) required target lesion revascularization and 1 (1.4%) patient succumbed from cardiovascular death.
Conclusions
Among STEMI patients with LTB, deferring stent optimization in the setting of pPCI appears safe and potentially mitigates the risk of DTE. The impact of this approach on infarct size and clinical outcomes warrants further investigation in a dedicated trial.
Atrial fibrillation (AF) is associated with changes in left atrial (LA) volume, but the relationship between LA size, AF burden, and electrical conduction behaviour is still uncertain. The aim of ...this study was to quantify the association and impact of these parameters on the single-procedure outcome after circumferential antral ablation for pulmonary vein isolation.
Left atrial assessment was performed in 129 consecutive patients using pre-procedural imaging in three dimensions (sphericity, indexed volume), two dimensions (diameters), and from echocardiography in one dimension (long axis). Atrial fibrillation burden was classified based on the clinical assessment as paroxysmal and persistent and based on a validated scoring system including frequency, duration of AF episodes, and number of cardioversions into four grades (minimal, mild, moderate, and severe). P-wave duration and PR interval was measured on the 12-lead electrocardiogram at the end of the procedure. Atrial fibrillation burden score (AFB) was minimal (2%), mild (75%), moderate (9%), and severe (14%) and 65% had paroxysmal and 35% had persistent AF. The recurrence rate was significantly higher in patients with persistent AF, with higher AFB, with prolonged P-wave, and with an indexed LA volume > 55 mL/m2. In multivariable analysis, AFB (hazard ratio: 2.018(1.383-2.945), P > 0.001) and a prolonged P-wave (hazard ratio: 2.612(1.248-5.466), P = 0.011) were identified as significant predictors for AF recurrence.
In our cohort of patients with symptomatic AF, the AFB and the P-wave duration but none of the anatomical parameter revealed to be independent predictors for AF/AT recurrence after circumferential antral pulmonary vein isolation.
We aimed to determine the association of a comprehensive healthy lifestyle with heart rate variability (HRV), a validated measure of autonomic function.
This was a prospective cohort study.
A ...population-based sample of 2079 individuals aged 25-41 years without prevalent cardiovascular disease was investigated. The standard deviation of all normal RR intervals (SDNN) during 24-hour electrocardiography was used as main HRV marker. Healthy lifestyle metrics were summed to a validated lifestyle-score ranging from 0 = most unhealthy to 7 = most healthy. One point was given for each of the following items: never smoking cigarettes; consuming a healthy diet; performing moderate (≥150 min/week) or vigorous (≥75 min/week) physical activity; body mass index (BMI)<25 kg/m(2); total cholesterol<200 mg/dl; glycated haemoglobin A1c<5.7%; and blood pressure<120 (systolic) and <80 mm Hg (diastolic).
Median age of the participants (47% males) was 37 years. Mean SDNN was 153 ms and median lifestyle-score was four. A score of 0/1 or 6/7 was found in 5.2% and 11.0%, respectively. In multivariable linear regression analysis with SDNN as the outcome variable, the β-estimate (95% confidence interval (CI)) for a one-point increase of the lifestyle-score was 0.14 (0.11-0.17), p < 0.0001. This relationship was attenuated but remained significant after additional adjustment for resting heart rate (HR) (β-estimate (95% CI) 0.07 (0.07-0.10), p < 0.0001) or 24-hour HR (0.04 (0.01-0.07), p = 0.003).
Few individuals adopted a healthy lifestyle in this large contemporary cohort of young adults from the general population. Adopting a healthy lifestyle has an important effect on autonomic function.