Impact of COVID-19-adapted guidelines using different airway management strategies on resuscitation quality in out-of-hospital-cardiac-arrest - a randomised manikin study.

BACKGROUND: Although airway management for paramedics has moved away from endotracheal intubation towards extraglottic airway devices in recent years, in the context of COVID-19, endotracheal intubation has seen a revival. Endotracheal intubation has been recommended again under the assumption that it provides better protection against aerosol liberation and infection risk for care providers than extraglottic airway devices accepting an increase in no-flow time and possibly worsen patient outcomes. METHODS: In this manikin study paramedics performed advanced cardiac life support with non-shockable (Non-VF) and shockable rhythms (VF) in four settings: ERC guidelines 2021 (control), COVID-19-guidelines using videolaryngoscopic intubation (COVID-19-intubation), laryngeal mask (COVID-19-Laryngeal-Mask) or a modified laryngeal mask modified with a shower cap (COVID-19-showercap) to reduce aerosol liberation simulated by a fog machine. Primary endpoint was no-flow-time, secondary endpoints included data on airway management as well as the participants' subjective assessment of aerosol release using a Likert-scale (0 = no release-10 = maximum release) were collected and statistically compared. Continuous Data was presented as mean ± standard deviation. Interval-scaled Data were presented as median and Q1 and Q3. RESULTS: A total of 120 resuscitation scenarios were completed. Compared to control (Non-VF:11 ± 3 s, VF:12 ± 3 s) application of COVID-19-adapted guidelines lead to prolonged no-flow times in all groups (COVID-19-Intubation: Non-VF:17 ± 11 s, VF:19 ± 5 s;p ≤ 0.001; COVID-19-laryngeal-mask: VF:15 ± 5 s,p ≤ 0.01; COVID-19-showercap: VF:15 ± 3 s,p ≤ 0.01). Compared to COVID-19-Intubation, the use of the laryngeal mask and its modification with a showercap both led to a reduction of no-flow-time(COVID-19-laryngeal-mask: Non-VF:p = 0.002;VF:p ≤ 0.001; COVID-19-Showercap: Non-VF:p ≤ 0.001;VF:p = 0.002) due to a reduced duration of intubation (COVID-19-Intubation: Non-VF:40 ± 19 s;VF:33 ± 17 s; both p ≤ 0.01 vs. control, COVID-19-Laryngeal-Mask (Non-VF:15 ± 7 s;VF:13 ± 5 s;p > 0.05) and COVID-19-Shower-cap (Non-VF:15 ± 5 s;VF:17 ± 5 s;p > 0.05). The participants rated aerosol liberation lowest in COVID-19-intubation (median:0;Q1:0,Q3:2;p < 0.001vs.COVID-19-laryngeal-mask and COVID-19-showercap) compared to COVID-19-shower-cap (median:3;Q1:1,Q3:3 p < 0.001vs.COVID-19-laryngeal-mask) or COVID-19-laryngeal-mask (median:9;Q1:6,Q3:8). CONCLUSIONS: COVID-19-adapted guidelines using videolaryngoscopic intubation lead to a prolongation of no-flow time. The use of a modified laryngeal mask with a shower cap seems to be a suitable compromise combining minimal impact on no-flowtime and reduced aerosol exposure for the involved providers.

Mortality in septic patients treated with vitamin C: a systematic meta-analysis.

BACKGROUND: Supplementation of vitamin C in septic patients remains controversial despite eight large clinical trials published only in 2020. We aimed to evaluate the evidence on potential effects of vitamin C treatment on mortality in adult septic patients. METHODS: Data search included PubMed, Web of Science, and the Cochrane Library. A meta-analysis of eligible peer-reviewed studies was performed in accordance with the PRISMA statement. Only studies with valid classifications of sepsis and intravenous vitamin C treatment (alone or combined with hydrocortisone/thiamine) were included. RESULTS: A total of 17 studies including 3133 patients fulfilled the predefined criteria and were analyzed. Pooled analysis indicated no mortality reduction in patients treated with vitamin C when compared to reference (risk difference - 0.05 [95% CI - 0.11 to - 0.01]; p = 0.08; p for Cochran Q = 0.002; I2 = 56%). Notably, subgroup analyses revealed an improved survival, if vitamin C treatment was applied for 3-4 days (risk difference, - 0.10 [95% CI - 0.19 to - 0.02]; p = 0.02) when compared to patients treated for 1-2 or > 5 days. Also, timing of the pooled mortality assessment indicated a reduction concerning short-term mortality (< 30 days; risk difference, - 0.08 [95% CI - 0.15 to - 0.01]; p = 0.02; p for Cochran Q = 0.02; I2 = 63%). Presence of statistical heterogeneity was noted with no sign of significant publication bias. CONCLUSION: Although vitamin C administration did not reduce pooled mortality, patients may profit if vitamin C is administered over 3 to 4 days. Consequently, further research is needed to identify patient subgroups that might benefit from intravenous supplementation of vitamin C.

Randomized trials of invasive cardiovascular interventions that include a placebo control: a systematic review and meta-analysis.

AIMS: The difference in the benefit of invasive cardiovascular interventions compared with placebo controls has not been analysed systematically. METHODS AND RESULTS: MEDLINE and Web of Science were searched through 29 March 2020. Randomized, placebo-controlled trials of invasive cardiovascular interventions (including catheter-based interventions and pacemaker-like devices) investigating predefined primary outcomes were included. Standardized mean differences (SMD) and odds ratios were calculated for continuous and dichotomous outcomes, respectively. Meta-regression analyses were performed to assess whether estimates of treatment effects were associated with methodological characteristics of trials. Thirty trials, including 4102 patients, were analysed. The overall risk of bias was judged to be low in only 43% of the trials. Ten trials (33%) demonstrated statistically significant superiority of invasive interventions over placebo controls for the respective predefined primary outcomes. In almost half of the 16 trials investigating continuous predefined primary outcomes, the SMD between the active and placebo procedure indicated a small (n = 4) to moderate (n = 3) treatment effect of active treatment over placebo. In contrast, one trial indicated a small treatment effect in favour of the placebo procedure. In the remaining trials, there was no relevant treatment effect of active treatment over placebo. In trials with a protocol-mandated stable and symmetrical use of co-interventions, the superiority of active procedures vs. invasive placebo procedures was significantly larger as compared with trials with frequent or unbalanced changes in co-interventions (P for interaction 0.027). CONCLUSIONS: The additional treatment effect of invasive cardiovascular interventions compared with placebo controls was small in most trials.

Renal Denervation: Is It Ready for Prime Time?

PURPOSE OF REVIEW: Interventional cardiology and in particular the field of renal denervation is subject to constant change. This review provides an up to date overview of renal denervation trials and an outlook on what to expect in the future. RECENT FINDINGS: After the sham-controlled SYMPLICITY HTN-3 trial dampened the euphoria following early renal denervation trials, the recently published results of the sham-controlled SPYRAL HTN and RADIANCE HTN trials provided proof-of-principle for the blood pressure-lowering efficacy of renal denervation. However, these studies underline the major issue of patients' non-adherence to antihypertensive medication as well as the need for reliable patient- and procedure-related predictors of response. The second generation of sham-controlled renal denervation trials provided proof of principle for the blood pressure-lowering efficacy of RDN. However, larger trials have to assess long-term safety and efficacy.

Indications and measures of medical emergency teams: a retrospective evaluation of in-hospital emergency operations of the German Resuscitation Register.

BACKGROUND: The present study examines characteristics and interventions of medical emergency teams (MET) in in-hospital emergency care. METHODS: Analysis of all in-hospital emergencies in patients ≥18 years at 62 hospitals with established MET from the database of the German Resuscitation Registry between 2014-2019. The evaluation covered indications for activation using the ABCDE-scheme, time intervals of arrival and patient care as well as the performed invasive/medical interventions. RESULTS: Out of 62 hospitals 14,166 in-hospital emergencies (male: 8033 [56.7%]; mean age: 64±18 years) were included. Causes of activation were circulation (5760 [40.7%]), disability (4076 [28.8%]), breathing (3649 [25.8%]) and airway-problems (1589 [11.2%]). Average arrival time at the emergency scene was 4±3 minutes, supply time of MET was 24±23 minutes. Endotracheal intubation was required in 1757 (12.4%) and difficult intubation occurred in 201 (11.4%) patients with the necessity for cricothyroidotomy in eight cases (3.9%). Invasive blood-pressure-measurement was indicated in 1074 (7.6%) patients. Catecholamines were required for hemodynamic stabilization in 2421 (17.1%) patients (norepinephrine: 1520 [10.7%], epinephrine: 430 [3.0%], dobutamine: 26 [0.2%]). CONCLUSIONS: Current in-hospital emergency care requires special skills in invasive hemodynamic and airway interventions. Recommendations from professional societies are necessary to optimize equipment (e.g. videolaryngoscopy, invasive blood pressure management), training, care algorithms and staff composition against the background of an increasing shortage of resources in the healthcare system.

State of implementation of the Corona-Virus-Disease-2019 resuscitation guidelines : An online-based survey one year after publication in Germany.

BACKGROUND: The present study evaluated the implementation of the European Resuscitation Council Corona-Virus-Disease 2019 (COVID-19) resuscitation guidelines in Germany 1 year after publication. AIM OF THE WORK: To evaluate the practical implementation of the COVID-19 resuscitation guidelines in Germany one year after their publication. MATERIAL AND METHODS: In an online survey between April and May 2021 participants were asked about awareness of COVID-19 resuscitation guidelines, corresponding training, the resuscitation algorithm used and COVID-19 infections of emergency medicine personnel associated with COVID-19 resuscitation. RESULTS: A total of 961 (8%) of the 11,000 members took part in the survey and 85% (818/961) of questionnaires were fully completed. While 577 (70%) of the respondents were aware of the COVID-19 guidelines, only 103 (13%) had received respective training. A specific COVID-19 resuscitation algorithm was used by 265 respondents (32%). Adaptations included personal protective equipment (99%), reduction of staff caring for the patient, or routine use of video laryngoscopy for endotracheal intubation (each 37%), securing the airway before rhythm analysis (32%), and pausing chest compressions during endotracheal intubation (30%). Respondents without a specific COVID-19 resuscitation algorithm were more likely to use mouth-nose protection (47% vs. 31%; p < 0.001), extraglottic airway devices (66% vs. 55%; p = 0.004) and have more than 4 team members close to the patient (45% vs. 38%; p = 0.04). Use of an Filtering-Face-Piece(FFP)-2 or FFP3 mask (89% vs. 77%; p < 0.001; 58% vs. 70%; p ≤ 0.001) or performing primary endotracheal intubation (17% vs. 31%; p < 0.001) were found less frequently and 9% reported that a team member was infected with COVID-19 during resuscitation. CONCLUSION: The COVID-19 resuscitation guidelines are still insufficiently implemented 1 year after publication. Future publication strategies must ensure that respective guideline adaptations are implemented in a timely manner.

AED delivery at night - Can drones do the Job? A feasibility study of unmanned aerial systems to transport automated external defibrillators during night-time.

BACKGROUND: In their recent guidelines the European Resuscitation Council have recommended the use of Unmanned Aerial systems (UAS) to overcome the notorious shortage of AED. Exploiting the full potential of airborne AED delivery would mandate 24 h UAS operability. However, current systems have not been evaluated for nighttime use. The primary goal of our study was to evaluate the feasibility of night-time AED delivery by UAS. The secondary goal was to obtain and compare operational and safety data of night versus day missions. METHODS: We scheduled two (one day, one night) flights each to ten different locations to assess the feasibility of AED delivery by UAS during night-time. We also compared operational data (mission timings) and safety data (incidence of critical events) of night versus day missions. RESULTS: All missions were completed without safety incident. The flights were performed automatically without pilot interventions, apart from manually choosing the landing site and correcting the descent. Flight distances ranged from 910 m to 6.960 m, corresponding mission times from alert to AED release between 3:48 min and 11:20 min. Night missions (T¯m:night = 7:26 ± 2:29 min) did not take longer than day missions (T¯m:day = 7:59 ± 2:27 min). Despite slightly inferior visibility of the target site, night landings (T¯land:night = 64 ± 15 sec) were on average marginally quicker than day landings (T¯land:day = 69 ± 11sec). CONCLUSIONS: Our results demonstrate the feasibility of UAS supported AED delivery during nighttime. Operational and safety data indicate no major differences between day- and night-time use. Future research should focus on integration of drone technology into the chain of survival.

Incidence, characteristics and risk factors for perioperative cardiac arrest and 30-day-mortality in preterm infants requiring non-cardiac surgery.

STUDY OBJECTIVE: To determine 30-day-mortality, incidence and characteristics of perioperative cardiac arrest as well as the respective independent risk factors in preterm infants undergoing non-cardiac surgery. DESIGN: Retrospective observational Follow-up-study. SETTING: Bielefeld University Hospital, a German tertiary care hospital. PATIENTS: Population of 229 preterm infants (age < 37th gestational week at the time of surgery) who underwent non-cardiac surgery between 01/2008-12/2018. MEASUREMENTS: Primary endpoint was overall 30-day-mortality. Secondary endpoints were the incidence of perioperative cardiac arrest and identification of independent risk factors. We performed univariate and multivariate analyses and calculated odds ratios (OR) for risk factors associated with these endpoints. MAIN RESULTS: 30-day-mortality was 10.9% and perioperative mortality 0.9%. Univariate risk factors for 30-day-mortality were perioperative cardiac arrest (OR,12.5;95%CI,3.1 to 50.3), comorbidities of lungs (OR,3.7;95%CI,1.2 to 11.3) and gastrointestinal tract (OR,3.5;95%CI,1.3 to 9.6); sepsis (OR,3.6;95%CI,1.4 to 9.5); surgery between 22:01-7:00 (OR,7.3;95%CI,2.4 to 21.7); emergency (OR,4.5;95%CI,1.6 to 12.4); pre-existing catecholamine therapy (OR,5.0;95%CI,2.1 to 11.9). Multivariate logistic regression indicated that perioperative cardiac arrest (OR,13.9;95%CI,2.7 to 71.3), low body weight (weight < 1000 g: OR,26.0;95%CI,3.2 to 212; 1000-1499 g: OR,10.3; 95%CI,1.1 to 94.9 compared to weight > 2000 g), and time of surgery (OR,5.9;95%CI,1.6 to 21.3) for 22:01-7:00 compared to 7:01-15:00) were the major independent risk factors of mortality. Incidence of perioperative cardiac arrests was 3.9% (9 of 229;95%CI,1.8 to 7.3). Univariate risk factors were congenital anomalies of the airways (OR,4.7;95%CI,1.2 to 20.3), lungs (OR,4.7;95%CI,1.2 to 20.3) and heart (OR,8.0;95%CI,2 to 32.2), pre-existing catecholamine therapy (OR,59.5;95%CI,3.4 to 1039), specifically, continuous infusions of epinephrine (OR,432;95%CI,43.2 to 4318). CONCLUSIONS: 30-day-mortality and the incidence of perioperative cardiac arrest of preterms undergoing non-cardiac surgery were higher than previously reported. The identified independent risk factors may improve interdisciplinary perioperative risk assessment, optimal preoperative stabilization and scheduling of optimal surgical timing.

Impact of COVID-19-adapted guidelines on resuscitation quality in out-of-hospital-cardiac-arrest: a manikin study.

BACKGROUND: The aim of this study is to evaluate the effects of European Resuscitation Council (ERC) COVID-19-guidelines on resuscitation quality emphasizing advanced airway management in out-of-hospital-cardiac-arrest. METHODS: In a manikin study paramedics and emergency physicians performed advanced cardiac life support in three settings: ERC guidelines 2015 (control), COVID-19-guidelines as suggested with minimum staff (COVID-19-minimal-personnel); COVID-19-guidelines with paramedics and an emergency physician (COVID-19-advanced-airway-manager). Main outcome measures were no-flow-time, quality metrics as defined by ERC and time intervals to first chest compression, oxygen supply, intubation and first rhythm analysis. Data were presented as mean±standard deviation. RESULTS: Thirty resuscitation scenarios were completed. No-flow-time was markedly prolonged in COVID-19-minimal-personnel (113±37 s) compared to control (55±9 s) and COVID-19-advanced-airway-manager (76±38s; P<0.001 each). In both COVID-19-groups chest compressions started later (COVID-19-minimal-personnel: 32±6 s; COVID-19-advanced-airway-manager: 37±7 s; each P<0.001 vs. control [21±5 s]), but oxygen supply (COVID-19-minimal-personnel: 29±5 s; COVID-19-advanced-airway-manager: 34±7 s; each P<0.001 vs. control [77±19 s]) and first intubation attempt (COVID-19-minimal-personnel: 111±14 s; COVID-19-advanced-airway-manager: 131±20 s; each P<0.001 vs. control [178±44 s]) were performed earlier. However, time interval to successful intubation was similar (control: 198±48 s; COVID-19-minimal-personnel: 181±42 s; COVID-19-advanced-airway-manager: 130±25 s) due to a longer intubation time in COVID-19-minimal-personnel (61±35 s) compared to COVID-19-advanced-airway-manager (P=0.002) and control (19±6 s; P<0.001). Time to first rhythm analysis was more than doubled in COVID-19-minimal-personnel (138±96 s) compared to control (50±12 s; P<0.001). CONCLUSIONS: Delayed chest compressions and prolonged no-flow-time markedly reduced the quality of resuscitation. These negative effects were attenuated by increasing the number of staff and by adding an experienced airway manager. The use of endotracheal intubation for reducing aerosol release during resuscitation should be discussed critically as its priorization is associated with an increase in no-flow-time.

Evolution and current state of global research on paediatric resuscitation: a systematic scientometric analysis.

BACKGROUND: Paediatric resuscitation is rare but potentially associated with maximal lifetime reduction. Notably, several nations experience high infant mortality rates even today. To improve clinical outcomes and promote research, detailed analyses on evolution and current state of research on paediatric resuscitation are necessary. METHODS: Research on paediatric resuscitation published in-between 1900 and 2019 were searched using Web of Science. Metadata were extracted and analyzed based on the science performance evaluation (SciPE) protocol. Research performance was evaluated regarding quality and quantity over time, including comparisons to adult resuscitation. National research performance was related to population, financial capacities, infant mortality rate, collaborations, and authors' gender. RESULTS: Similar to adult resuscitation, research performance on paediatric resuscitation grew exponentially with most original articles being published during the last decade (1106/1896). The absolute number, however, is only 14% compared to adults. The United States dominate global research by contributing the highest number of articles (777), Hirsch-Index (70), and citations (18,863). The most productive collaboration was between the United States and Canada (52). When considering nation's population and gross domestic product (GDP) rate, Norway is leading regarding population per article (62,467), per Hirsch-Index (223,841), per citation (2226), and per GDP (2.3E-04). Regarding publications per infant mortality rate, efforts of India and Brazil are remarkable. Out of the 100 most frequently publishing researchers, 25% were female. CONCLUSION: Research efforts on paediatric resuscitation have increased but remain underrepresented. Specifically, nations with high infant mortality rates should be integrated by collaborations. Additional efforts are required to overcome gender disparities.

Contemporary scientometric analyses using a novel web application: the science performance evaluation (SciPE) approach.

AIMS: We aimed at developing a structured study protocol utilizing the bibliographic web-application science performance evaluation (SciPE) to perform comprehensive scientometric analyses. METHODS AND RESULTS: Metadata related to publications derived from online databases were processed and visualized by transferring the information to an undirected multipartite graph and distinct partitioned sets of nodes. Also, institution-specific data were normalized and merged allowing precise geocoordinate positioning, to enable heatmapping and valid identification. As a result, verified, processed data regarding articles, institutions, journals, authors gender, nations and subject categories can be obtained. We recommend including the total number of publications, citations, the population, research institutions, gross domestic product, and the country-specific modified Hirsch Index and to form corresponding ratios (e.g., population/publication). Also, our approach includes implementation of bioinformatical methods such as heatmapping based on exact geocoordinates, simple chord diagrams, and the central implementation of specific ratios with plain visualization techniques. CONCLUSION: This protocol allows precise conduction of contemporaneous scientometric analyses based on bioinformatic and meta-analytical techniques, allowing to evaluate and contextualize scientific efforts. Data presentation with the depicted visualization techniques is mandatory for transparent and consistent analyses of research output across different nations and topics. Research performance can then be discussed in a synopsis of all findings.

Accuracy of pulse rate derived from 24-h ambulatory blood pressure monitoring compared with heart rate from 24-h Holter-ECG.

BACKGROUND: Resting heart rate (HR) associates with cardiovascular outcomes in the general population and in patients with hypertension and heart failure. The accuracy of pulse rate acquired by 24-h ambulatory blood pressure monitoring (ABPM-PR) in comparison with Holter-ECG HR (Holter-HR) is unknown. OBJECTIVE: We aimed at investigating the accuracy of ABPM-PR when compared with Holter-HR. METHODS AND RESULTS: The current study included 1500 patients of a general cardiology outpatient unit undergoing simultaneous Holter and ABPM recordings. ABPM-PR differed marginally from Holter-HR by 0.55 bpm for 24-h average [95% confidence interval (CI): 0.37-0.73, P < 0.001], 1.27 bpm for daytime (95% CI: -0.98-1.56, P < 0.001) and 0.63 bpm for night-time (95% CI: 0.40-0.86 bpm; P < 0.001). The absolute delta between 24-h Holter-HR and ABPM-PR was less than 5 and less than 10 bpm in 1363 (91%) and 1458 (97%) patients, respectively. 24-h ABPM-PR more commonly underestimated than overestimated (7 versus 2%) 24-h Holter-HR by at least 5 bpm. The mean difference between Holter-HR and ABPM-PR was higher (+1.9 bpm; 95% CI: 0.9-3.0; P < 0.001) in patients with than without atrial fibrillation. There was no significant difference between Holter-HR and ABPM-PR in patients without supraventricular or ventricular extrasystoles (both P ≥ 0.750). CONCLUSION: ABPM-PR did not differ clinically meaningful from Holter-HR recordings in most patients and might be useful for risk prediction in hypertension.

Correction to: One­year clinical outcomes in patients with renal insuffciency after contemporary PCI: data from a multicenter registry.

The original version of this article unfortunately contained a mistake. The given name and family name of the fourth author Saaraaken Kulenthiran were switched in the original publication.

Survival After Coronary Revascularization With Paclitaxel-Coated Balloons.

BACKGROUND: Drug-coated balloons (DCBs) are accepted treatment strategies for coronary in-stent restenosis and are under clinical investigation for lesions without prior stent implantation. A recently published meta-analysis suggested an increased risk of death associated with the use of paclitaxel-coated devices in the superficial femoral artery. The reasons are incompletely understood as potential underlying pathomechanisms remain elusive, and no relationship to the administered dose has been documented. OBJECTIVES: The purpose of this analysis was to investigate the available data on survival after coronary intervention with paclitaxel-coated balloons from randomized controlled trials (RCTs). METHODS: PubMed, Web of science, and the Cochrane library database were searched, and a meta-analysis from RCT was performed comparing DCB with non-DCB devices (such as conventional balloon angioplasty, bare-metal stents, or drug-eluting stents) for the treatment of coronary in-stent restenosis or de novo lesions. The primary outcome was all-cause death. The number of patients lost to follow-up was observed at different time points. Risk estimates are reported as risk ratios (RRs) with 95% confidence intervals (CIs). RESULTS: A total of 4,590 patients enrolled in 26 RCTs published between 2006 and 2019 were analyzed. At follow-up of 6 to 12 months, no significant difference in all-cause mortality was found, however, with numerically lower rates after DCB treatment (RR: 0.74; 95% CI: 0.51 to 1.08; p = 0.116). Risk of death at 2 years (n = 1,477, 8 RCTs) was similar between the 2 groups (RR: 0.84; 95% CI: 0.51 to 1.37; p = 0.478). After 3 years of follow-up (n = 1,775, 9 RCTs), all-cause mortality was significantly lower in the DCB group when compared with control treatment (RR: 0.73; 95% CI: 0.53 to 1.00; p = 0.047) with a number needed to treat of 36 to prevent 1 death. A similar reduction was seen in cardiac mortality (RR: 0.53; 95% CI: 0.33 to 0.85; p = 0.009). CONCLUSIONS: In this meta-analysis, the use of paclitaxel DCBs for treatment of coronary artery disease was not associated with increased mortality, as has been suggested for peripheral arteries. On the contrary, use of coronary paclitaxel-coated balloons was associated with a trend toward lower mortality when compared with control treatments.

One-year clinical outcomes in patients with renal insufficiency after contemporary PCI: data from a multicenter registry.

BACKGROUND: Chronic kidney disease (CKD) is highly prevalent in patients with coronary artery disease (CAD). OBJECTIVE: The outcome following revascularization using contemporary technologies (new-generation abluminal sirolimus-eluting stents with thin struts) in patients with CKD (i.e., glomerular filtration rate of < 60 mL/min/1.73m2) and in patients with hemodialysis (HD) is unknown. METHODS: e-Ultimaster is a prospective, single-arm, multi-center registry with clinical follow-up at 3 months and 1 year. RESULTS: A total of 19,475 patients were enrolled, including 1466 patients with CKD, with 167 undergoing HD. Patients with CKD had a higher prevalence of overall comorbidities, multiple/small vessel disease (≤ 2.75 mm), bifurcation lesions, and more often left main artery treatments (all p < 0.0001) when compared with patients with normal renal function (reference). CKD patients had a higher risk of target lesion failure (unadjusted OR, 2.51 [95% CI 2.04-3.08]), target vessel failure (OR, 2.44 [95% CI 2.01-2.96]), patient-oriented composite end point (OR, 2.19 [95% CI 1.87-2.56]), and major adverse cardiovascular events (OR, 2.34 [95% CI 1.93-2.83, p for all < 0.0001]) as reference. The rates of target lesion revascularization (OR, 1.17 [95% CI 0.79-1.73], p = 0.44) were not different. Bleeding complications were more frequently observed in CKD than in the reference (all p < 0.0001). CONCLUSION: In this worldwide registry, CKD patients presented with more comorbidities and more complex lesions when compared with the reference population. They experienced higher rate of adverse events at 1-year follow-up. One-year summary outcomes of contemporary PCI in renal insufficiency. CKD chronic kidney disease, POCE patient oriented composite endpoint, MACE major adverse cardiovascular events, TLF target lesion failure, TLR target lesion revascularization, ST stent thrombosis.

Peripheral edema and headache associated with amlodipine treatment: a meta-analysis of randomized, placebo-controlled trials.

OBJECTIVE: Use of amlodipine for treatment of arterial hypertension and stable coronary artery disease (CAD) is sometimes limited by occurrence of peripheral edema and headache. We aimed to explore the true magnitude of this phenomenon by determining the rate and placebo-adjusted rate of these side effects. METHODS: We performed a meta-analysis by including all randomized, placebo-controlled trials reporting edema and headache with amlodipine in patients with arterial hypertension and CAD. Placebo-adjusted rate (%) was determined as follows: (SE amlodipine % - SE placebo %)/SE amlodipine %. RESULTS: Data from 7226 patients of 22 trials were analyzed. Rate of edema was higher on amlodipine vs. placebo (16.6 vs. 6.2%, risk ratio: 2.9, 95% CI: 2.50-3.36, P < 0.0001). The placebo-adjusted rate was 63%, indicating that 37% of edema cases were unrelated to amlodipine. Treatment with low/medium doses (2.5-5 mg) resulted in lower rates of edema (risk ratio: 2.01, 95% CI: 1.41-2.88, P = 0.0001) vs. high dose (10 mg) (risk ratio: 3.08, 95% CI 2.62-3.60, P < 0.0001, Pforinteraction = 0.03). Incidence of headache was reduced using amlodipine vs. placebo (7.9 vs. 10.9%, risk ratio: 0.77, 95% CI: 0.65-0.90, P = 0.002) and was driven by use of low/medium doses (risk ratio: 0.52, 95% CI: 0.40-0.69, P < 0.00001 vs. risk ratio: 0.92, 95%-CI: 0.74-1.15, P = 0.45, for high doses, Pforinteraction = 0.002). CONCLUSION: Although risks of peripheral edema are three-fold higher on amlodipine, up to one-third of edema cases on amlodipine might not be induced by amlodipine. Headache is reduced on amlodipine treatment, mainly driven by use of this drug at low/medium doses.

Effects of Arteriovenous Fistula on Blood Pressure in Patients With End-Stage Renal Disease: A Systematic Meta-Analysis.

Background Central arteriovenous fistula ( AVF ) creation is under investigation for treatment of severe hypertension. We evaluated the effects of AVF for initiation of hemodialysis on systolic, diastolic, and mean arterial blood pressure in patients with end-stage renal disease. Methods and Results Data search included PubMed, Web of Science, and the Cochrane Library. A systematic review and meta-analysis of peer-reviewed studies reporting the effects of the creation/ligation of an AVF on blood pressure in patients with end-stage renal disease was performed according to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analysis), PRISMA -P (PRISMA for systematic review protocols), and ROBINS-I (Risk of Bias in Non-Randomized Studies) criteria by the Cochrane Bias Methods Group. All studies in which the results could have been biased by hemodialysis were excluded. A total of 14 trials including 412 patients with end-stage renal disease ( AVF creation, n=185; AVF ligation, n=227) fulfilled the criteria and were subsequently analyzed. Average blood pressure in patients with no/closed AVF was 140.5/77.6 mm Hg with a mean arterial blood pressure of 96.1 mm Hg. Following creation of AVF , systolic blood pressure significantly decreased by 8.7 mm Hg ( P<0.001), diastolic blood pressure by 5.9 mm Hg ( P<0.001), and mean arterial blood pressure by 6.6 mm Hg ( P=0.02), whereas after ligation systolic blood pressure increased by 5.2 mm Hg ( P=0.07), diastolic blood pressure by 3.8 mm Hg ( P=0.02), and mean arterial blood pressure by 3.7 mm Hg ( P=0.07) during short- to long-term follow-up. Conclusions Creation of AVF significantly decreases blood pressure in patients with end-stage renal disease, whereas blood pressure tends to increase after ligation. These findings illustrate the hemodynamic consequences of AVF which are under investigation for severe hypertension.