scholarly journals Effects of chronic remote ischemic conditioning on atrial fibrillation burden in patients with permanent pacemakers

2020 ◽  
Author(s):  
Long Chen ◽  
Yaowu Liu ◽  
Didi Zhu ◽  
Jinbo Yu ◽  
Chunlei Yu ◽  
...  

Abstract Background: The burden of atrial fibrillation (AF) has been attractive recently and may be associated with stroke risk and mortality. Remote ischemic conditioning could reduce the incidence, inducibility and sustainability of AF. But the effects of chronic remote ischemic conditioning (CRIC) on atrial fibrillation burden in patients with pacemaker implanted are still unknown.Design: This was a single‑center, prospective, randomized, open-labeled clinical study.Methods: Sixty-six patients with permanent pacemakers were randomly divided into CRIC group and control group after 4 weeks screening. CRIC treatment was performed twice a day for 12 weeks. A remote ischemic conditioning protocol consisted of 4 × 5 min inflation/deflation of the blood pressure cuff applied in the upper arm to create intermittent arm ischemia. Pacemaker programming was performed for four times: before screening (-4-week), after screening and before randomization (0-week, baseline), 4-week and 12-week follow-up. Data including AF burden, longest duration of AF and cumulative numbers of atrial high-rate episodes (AHREs) were collected.Results: Sixty-one patients (31 patients in CRIC group and 30 patients in control group) completed the study. CRIC was well-tolerated by patients after 12 weeks treatment. The burden of AF in CRIC group was decreased significantly at 4-week compared with that at 0-week (14.7%±18.5% vs 17.0%±20.7%, p < 0.001), which further decreased at 12-week compared with that at 0-week (8.6%±10.2% vs 17.0%±20.7%, p < 0.001) and that at 4-week (8.6%±10.2% vs 14.7%±18.5%, p < 0.001), which was not observed in the control group. AF burden also reduced significantly after 12-week CRIC compared with that in control group (8.6%±10.2% vs 17.6%±19.5%, p = 0.013). Repeated measurement ANOVA showed that the changes of AF burden was associated with CRIC instead of time (p < 0.01). In addition, there were trends that longest duration of AF and cumulative numbers of AHREs were reduced after 12-week CRIC.Conclusions: This study suggests that a 12-week course of CRIC treatment could reduce AF burden in patients with permanent pacemakers, supporting widespread use of CRIC in the daily lives of these patients, which need to be verified in the future.Clinical Trial RegistrationRegistration name: Effects of remote ischemic conditioning on atrial fibrillation burden in patients with paroxysmal atrial fibrillationRegistration number: ChiCTR-IOR-17012666Registered 14 September 2017; URL: www.chictr.org.cn/showproj.aspx?proj=21591

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Inga Kiudulaite ◽  
Egle Belousoviene ◽  
Astra Vitkauskiene ◽  
Andrius Pranskunas

Abstract Background Remote ischemic conditioning (RIC) is a promising technique that may protect organs and tissues from the effects of additional ischemic episodes. However, the therapeutic efficacy of RIC in humans with sepsis remains unknown. We hypothesized that RIC might improve sublingual microcirculation in patients with sepsis. Methods This prospective single-arm trial was performed in a mixed ICU at a tertiary teaching hospital. We included patients with sepsis or septic shock within 24 h of ICU admission. The RIC procedure comprised 3 cycles of brachial cuff inflation to 200 mmHg for 5 min followed by deflation to 0 mmHg for another 5 min. The procedure took 30 min. RIC was performed at the time of study inclusion and repeated after 12 and 24 h. Sublingual microcirculatory measurements were obtained before and after each RIC procedure using a Cytocam®-incident dark-field (IDF) device (Braedius Medical, Huizen, The Netherlands). The microcirculatory data were compared with a historical control. Data are reported as the medians along with the 25th and 75th percentiles. Results Twenty-six septic patients with a median age of 65 (57–81) years were enrolled in this study. The median Acute Physiology and Chronic Health Evaluation (APACHE) II and Sequential Organ Failure Assessment (SOFA) scores at admission were 20 (13–23) and 10 (9–12), respectively. All patients were receiving vasopressors. After the 1st RIC procedure, the microvascular flow index (MFI) and the proportion of perfused vessels (PPV) among small vessels were significantly higher than before the procedure, with pre- and post-treatment values of 2.17 (1.81–2.69) and 2.59 (2.21–2.83), respectively, for MFI (p = 0.003) and 87.9 (82.4–93.8) and 92.5 (87.9–96.1) %, respectively, for PPV (p = 0.026). This result was confirmed by comparison with a historical control group. We found no change in microcirculatory flow or density parameters during repeated RIC after 12 h and 24 h. Conclusion In patients with sepsis, the first remote ischemic conditioning procedure improved microcirculatory flow, whereas later procedures did not affect sublingual microcirculation. Trial registration NCT04644926, http://www.clinicaltrials.gov. Date of registration: 25 November 2020. Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT04644926.


Stroke ◽  
2017 ◽  
Vol 48 (suppl_1) ◽  
Author(s):  
Yuan Wang ◽  
Haiqing Song ◽  
Kai Dong ◽  
Ran Meng ◽  
Shuying Wang ◽  
...  

Objective: To evaluate the preliminary efficacy of remote ischemic conditioning (RIC) on patients with cerebral small vessel disease (SVD). Methods: Thirty patients diagnosed with symptomatic SVD within 30 days of onset were enrolled in this prospectively randomized controlled study for 1 year. All patients received routine medical treatment including treating vascular risk factors according to the guideline. Patients in the experimental group (n=14) were administered 5 cycles consisting of ischemia followed by reperfusion for 5 minutes on bilateral upper limbs twice daily for 1 year. Those in the control group (n=16) underwent sham ischemia-reperfusion cycles. Primary outcome was the change of cognitive function measured by mini-mental state examination (MMSE) and montreal cognitive assessment scale (MoCA), and secondary outcomes were changes of plasma biomarkers, cerebral hemodynamic parameters measured by vascular ultrasound and brain lesions measured by MRI FLAIR both at baseline and at the end of 1 year visit. Results: Compared with patients in the control group, patients in the RIC group had higher flow velocity (FV), and lower pulsatility index (PI), but without statistical difference. Patients in the RIC group had improvement in visuospatial and executive abilities (3.86±1.03 vs. 4.43±0.85, p=0.026), reduced plasma triglyceride (1.60±0.74 vs. 1.25±0.38, p=0.019), low density lipoprotein (2.89±0.81 vs. 2.26±0.67, p=0.003) and homocysteine (15.66±10.11 vs. 13.66±9.80 p=0.017). Similarly in the RIC group, the diastolic flow velocity (DFV) of middle cerebral artery (MCA) (right: 33.93±7.67 vs. 36.93±6.12, p=0.032; left: 33.93±7.67 vs. 36.93± 6.12, p=0.032) and the mean flow velocity (MFV) of left MCA (35.00±5.04 vs. 39.50±5.59, p=0.003) increased, and the PI of MCA (right: 1.11±0.19 vs. 1.02±0.14 p=0.030; left: 1.10±0.22 vs. 0.99±0.14, p=0.037) decreased. Conclusion: RIC appears to be potentially effective for improving cognition, enhancing cerebral perfusion, and modifying vascular risk factors in SVD patients. Further studies focusing on long-term neurological outcomes and potential mechanisms underlying RIC on SVD patients are needed.


2021 ◽  
Author(s):  
Edouard Chambon ◽  
Emmanuelle Fournier ◽  
Maha Tagorti ◽  
Florence Lecerf ◽  
Nadera Chaouche ◽  
...  

Abstract Anxiety before an invasive intervention is associated in children with persistent psychological disorders. We studied the effect of the transfer to the catheterization room by an electric toy-car on the anxiety of children and their parents before a cardiac catheterization. Forty-eight children with a median age of 5.6 years [4.2-7.0] were randomized to either riding on an electric car to go to the catheterization laboratory or being transported lying supine on a gurney. Anxiety assessments were performed by a physician blinded to allocation group on the day before the procedure (T0) and at anesthesia induction (T1). The modified Yale score (mYPAS-SF) and visual analog scale for anxiety (VAS-A) were used in the children, and the VAS-A in the parents. The mYPAS-SF, VAS-A-child and the VAS-A-parent scores were significantly higher at T1 than at T0 (P < 0.001, P < 0.001, and P = 0.005, respectively). The primary outcome (the median mYPAS-SF score at T1) was not significantly different in the two groups when males and females were combined. At T1, the VAS-A-child score, however, was significantly lower in the intervention than the control group (22 versus 55, P < 0.001). In the boys, the median mYPAS-SF score at T1 was significantly lower in the intervention group (25.0 versus 51.0, P = 0.024). No difference was observed in girls. The VAS-A parent score was lower at T1 in the intervention group (60 versus 87, P = 0.05). Conclusion: Riding to the catheterization laboratory on an electric toy car decreased anxiety at anesthesia induction in boys and also decreased parental anxiety.Clinical trial Registration: Registration number: ID-RCB: 2019-A00459-48. Date of registration: March 27th 2019.


Stroke ◽  
2014 ◽  
Vol 45 (suppl_1) ◽  
Author(s):  
Mark Connolly ◽  
Joshua Dusick ◽  
Paul Vespa ◽  
Nestor Gonzalez

Objective: Remote ischemic conditioning (RIC) is a phenomenon by which brief periods of sublethal ischemia in one tissue confers protection from ischemia to distant tissues. The safety and feasibility of RIC must be assessed before testing it in efficacy trials. We report a phase I feasibility and safety trial of RIC in aneurysmal subarachnoid hemorrhage (aSAH) patients. Methods: Patients with aSAH received 2-4 RIC sessions on non-consecutive days. A complete session was defined as four rounds of 5 minutes of one sided lower limb ischemia with a thigh blood pressure cuff followed by 5 minutes of reperfusion (verified by pedal Doppler). Primary end-points were tolerance to the procedure and any complication attributable to RIC. Secondary end-points included cerebral infarction or hemorrhage. Results: Twenty-one patients (67% female, mean age 52, Fisher 3.5, H&H 3.3) were enrolled. Seventeen had evidence of vasospasm during hospitalization. Of 76 RIC sessions performed, 75 (98.7%) were completed and tolerated. One session was incomplete due to poor cooperation secondary to delirium. No patients developed DVTs or other local complications within 2 weeks of their final RIC session. No patients suffered cerebral infarction or hemorrhage throughout the duration of RIC sessions and through 72 hours after their last complete session. Three had infarction confirmed on MRI at 3 and 5 days following the final RIC session. In conscious patients, there was a small increase in the analog pain scale upon inflation of the cuff (deflated: 0.5 inflated: 1.2, p<0.0005), but none requested to stop the session. There was no significant change in other vitals. Conclusions: In aSAH patients, RIC was successfully applied and well tolerated with no procedure-related complications. No patient suffered ischemic stroke within 72 hours of RIC, consistent with our previous studies showing protective cerebral metabolic changes up to 48 hours after sessions. These results demonstrate that application of RIC is safe and feasible and suggest that RIC may be associated with transient tolerance to ischemia during the treatment period. The efficacy of RIC for neuroprotection should be investigated in larger controlled trials.


EP Europace ◽  
2020 ◽  
Vol 22 (7) ◽  
pp. 1017-1025
Author(s):  
Vidal Essebag ◽  
Zahra Azizi ◽  
Pouria Alipour ◽  
Yaariv Khaykin ◽  
Peter Leong-Sit ◽  
...  

Abstract Aims Atrial fibrillation (AF) significantly impairs patients’ quality of life (QOL). We performed this study to investigate the effect of AF-ablation success and atrial fibrillation burden (AFB) on QOL measures. Methods and results Overall, 230 patients with paroxysmal AF refractory to antiarrhythmic drugs were enrolled and underwent ablation in a multicentre, prospective cohort. Electrocardiogram, 48-h Holter, Canadian Cardiovascular Society Severity of Atrial Fibrillation (CCS-SAF), short form-12 (SF-12), and Atrial Fibrillation Effect on Quality of life (AFEQT) scales were used to assess patients. Atrial fibrillation burden was defined as total duration of AF during the month prior to each visit (h/month). The change in AFB was calculated as the difference between the month prior to the 12-month post-ablation and the baseline pre-ablation. The Minimal Clinically Important Difference (MCID) was considered as a 19-point change for AFEQT and 3–5-point change for SF-12 scores. There was significant rise in the AFEQT and SF12 and decrease in CCS-SAF score post-AF ablation; however, the magnitude of these changes was greater in patients without AF recurrence (P &lt; 0.05). The QOL score that best differentiated patients with and without recurrence was AFEQT, while, CCS-SAF was the most specific score. Patients with AFB decrease &gt;19 h/month had significantly greater change in QOL scores. Atrial fibrillation burden &lt; 24 h/month at 12-months post-ablation was associated with significant changes in QOL and CCS-SAF when adjusting for baseline scores and other covariates. These changes were consistent with the MCID of these measures. Conclusion Patients experience significant improvements in QOL post-ablation, which correlate with a decrease in AFB despite ongoing brief recurrences of AF. Clinical Trial Registration NCT01562912. https://www.clinicaltrials.gov/ct2/show/NCT01562912? term=capcost&rank=1


2019 ◽  
Vol 15 (4) ◽  
pp. 454-460
Author(s):  
Xiao-Qiu Li ◽  
Lin Tao ◽  
Zhong-He Zhou ◽  
Yu Cui ◽  
Hui-Sheng Chen ◽  
...  

Rationale A large number of basic and clinical studies have proved that remote ischemic conditioning has neuroprotective effect. For example, remote ischemic conditioning showed a neuroprotective role in cerebral ischemia-reperfusion injury model. Recent clinical studies suggested that remote ischemic conditioning may improve neurological function and reduce the risk of recurrence in ischemic stroke patients. However, there is a lack of convincing evidence for the neuroprotective effect of remote ischemic conditioning on ischemic stroke, which deserves further study. Aim To explore the efficacy and safety of remote ischemic conditioning for acute moderate ischemic stroke. Sample size estimates A maximum of 1800 subjects are required to test the superiority hypothesis with 80% power according to a one-sided 0.025 level of significance, stratified by gender, age, time from onset to treatment, National Institutes of Health Stroke Scale (6–10 vs. 11–16), degree of responsible vessel stenosis, location of stenosis, and stroke etiology. Methods and design Remote Ischemic Conditioning for Acute Moderate Ischemic Stroke is a prospective, random, open label, blinded endpoint and multi-center study. The subjects are divided into experimental group and control group randomly. The experimental group was treated with remote ischemic conditioning twice daily with 200 mmHg pressure for 10–14 days besides guideline-based therapy. The control group was treated according to the guidelines. Study outcome The primary efficacy endpoint is favorable functional outcome, defined as modified Rankin Scale 0–1 at 90 days post-randomization.


Diagnostics ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. 1107
Author(s):  
Elina Trendafilova ◽  
Elena Dimitrova ◽  
Jean-Philippe Didon ◽  
Vessela Krasteva

A few randomized trials have compared impedance-compensated biphasic defibrillators in clinical use. We aim to compare pulsed biphasic (PB) and biphasic truncated exponential (BTE) waveforms in a non-inferiority cardioversion (CVS) study. This was a prospective monocentric randomized clinical trial. Eligible patients admitted for elective CVS of atrial fibrillation (AF) between February 2019 and March 2020 were alternately randomized to treatment with either a PB defibrillator (DEFIGARD TOUCH7, Schiller Médical, Wissembourg, France) or a BTE high-energy (BTE-HE) defibrillator (LIFEPAK15, Physio-Control Inc., Redmond, WA, USA). Fixed-energy protocol (200–200–200 J) was administered. CVS success was accepted if sinus rhythm was restored at 1 min post-shock. The study design considered non-inferiority testing of the primary outcome: cumulative delivered energy (CDE). Seventy-three out of 78 randomized patients received allocated intervention: 38 BTE-HE (52%), 35 PB (48%). Baseline characteristics were well-balanced between groups (p > 0.05). Both waveforms had similar CDE (mean ± standard deviation, 95% confidence interval): BTE-HE (253.9 ± 120.2 J, 214–293 J) vs. PB (226.0 ± 109.8 J, 188–264 J), p = 0.31. Indeed, effective PB shocks delivered significantly lower energies by mean of 25.6 J (95% CI 24–27.1 J, p < 0.001). Success rates were similar (BTE-HE vs. PB): 1 min first-shock (84.2% vs. 82.9%), 1 min CVS (97.4% vs. 94.3%), 2 h CVS (94.7% vs. 94.3%), 24 h CVS (92.1% vs. 94.3%), p > 0.05. Safety analysis did not find CVS hazards, reporting insignificant changes of myocardial-specific biomarkers, transient and rare ST-segment deviations, and no case of harmful tachyarrhythmias and apnea. Cardioversion of AF with fixed-energy protocol 200–200–200 J was highly efficient and safe for both PB and BTE-HE waveforms. These similar performances were achieved despite differences in the waveforms’ technical design, associated with significantly lower delivered energy for the effective PB shocks. Clinical Trial Registration: Registration number: NCT04032678, trial register: ClinicalTrials.gov.


2020 ◽  
Author(s):  
Chunxia Huang ◽  
ZhiMin Zhang ◽  
Bin Li ◽  
YunTian Li

Abstract Background: Atrial fibrillation (AF) is the common arrhythmia resulting in high morbidity and mortality. Ibutilide is used to convert AF to sinus rhythm pharmacologically. We aimed to evaluate the clinical efficacy and safety of ibutilide for patients over 75 years old with recent onset AF.Methods: 81 patients over 75 years old with recent onset AF less than 72 hours, range from 75 to 85 years, were analyzed retrospectively from January 2015 to January 2019. 40 patients received ibutilide, and another 41 patients received propafenone as the control group. In ibutilide group, patients weighing over 60 kg were received 1 mg of ibutilide, and ibutilide at 0.01 mg / kg were administrated when the patient’s body weight was less than 60 kg. If cardioversion failed, 1 mg or 0.01 mg/kg of ibutilide would be given after 10 minutes. In control group, patients were received propafenone at 75mg. If there was no effect on cardioversion, 35 mg of propafenone would be given after 10 minutes.Results: In control group 26 patients (63.4%) converted to sinus rhythm, and in ibutilide group, 35(87.5%) converted to sinus rhythm (p<0.05, vs control group). The converting time of ibutilide group was shorter than control group(13.5±9.27s vs 43.72±10.27s,P<0.05 ). The corrected QT (QTc) intervals was significantly prolonged in patients after the administration of ibutilide(P<0.05). In ibutilide group, five patients (12.5%) appeared torsades de pointes (TdP) and converted to sinus rhythm via electrical cardioversion. Six patients (14.6%) developed severe bradycardia in control group, and the bradycardia alleviated after discontinuation of propafenone. Nine patients (21.9%) who failed in cardioversion with 24 hours by propafenone converted to sinus rhythm via electrical cardioversion.Conclusion: Ibutilide could effectively convert recent onset (<72 hours) AF in patients aged over 75 years. However, it was worth noting that the high rate of TdP emerged in these elderly patients after the treatment of ibutilide.


Stroke ◽  
2012 ◽  
Vol 43 (suppl_1) ◽  
Author(s):  
Changhong Ren ◽  
Mingqing Gao ◽  
Ning Li ◽  
Jinqiang Cao ◽  
Yuchuan Ding ◽  
...  

Background and Purpose _Remote ischemic conditioning (RIC) has been shown to provide neuroprotective effects, but the precise mechanisms underlying the therapeutic effects still remain unclear. In this study, we investigate changes in blood-brain barrier (BBB) permeability and edema formation, in association with expression of matrix metalloproteinases (MMP), tight junction proteins and aquaporins (AQP) in RIC treated rats following unilateral middle cerebral artery (MCA) occlusion and reperfusion. Methods _Ischemic stroke model was generated by occlusion of the right MCA for 1.5 hours in male Sprague-Dawley rats. Remote ischemic conditioning was conducted immediately after MCA occlusion in the bilateral lower limb by occluding and releasing the femoral artery for three cycles; each occlusion and release lasted for 10 minutes. Edema levels and BBB integrity were studied by quantification of brain water content and extravasations of Evans blue at 48 hours after reperfusion, respectively. Protein expression of occludin, claudin-5, ZO-1, MMP-2, MMP-9, as well as AQP-4 and AQP-9, were determined by Western blot analysis at 48 hours after reperfusion. The activity of MMP-2 and MMP-9 were determined by gelatin zymography at the same time points. Results _Treatment with RIC significantly ( P <0.05) reduced brain edema ( P <0.01) and BBB dysfunction when compared to the control ischemic groups. IPC treatment resulted in a significant ( P <0.05) increase in the expression of tight junction protein occludin in comparison to the control non-treatment group. The expressions of claudin-5 and ZO-1were not different between RIC-treated group and control group. RIC treatment diminished ischemia-induced MMP-9 ( P <0.01) but not MMP-2. The expressions of AQP-4 and AQP-9 were not different between RIC-treated group and control group. Conclusions _RIC ameliorates brain edema and BBB disruption after stroke, in association with a reduction of MMP-9 and increase in the expression of tight junction protein occludin. These results provide clues to neuroprotective properties of RIC.


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
H R Lieder ◽  
M Tsoumani ◽  
I Andreadou ◽  
G Heusch ◽  
P Kleinbongard

Abstract Background/Introduction Brief episodes of ischemia/reperfusion (I/R) in a tissue or organ remote from the heart reduce myocardial infarct size after sustained severe myocardial I/R in all species tested so far, including humans. Remote ischemic conditioning can be induced before (pre-), during (per-) or following (post-) myocardial ischemia. Signal transfer from the remote tissue/organ to the heart is both, neuronal and humoral. Humoral signal transfer has been evidenced by the transfer of cardioprotection via plasma or plasma derivatives from one individual to another individual's heart, even across species. Circulating blood cells have been considered as targets for cardioprotection, but so far not as carriers of cardioprotective signals. Purpose To investigate the role of platelets as potential carriers of cardioprotection by remote ischemic preconditioning (RIPC). Methods Peripheral venous blood samples were collected from healthy volunteers (5 male/5 female, mean age 26±5 years) before and 60 min after RIPC (3×5 min blood pressure cuff inflation at 200 mmHg on the left upper arm/5 min deflation) or placebo (PLA) protocol (blood pressure cuff uninflated). RIPC and PLA protocols, respectively, were performed in randomized sequence at an interval of one week. Blood (80 mL) was drawn into tubes containing sodium citrate, apyrase and prostaglandin E1. Blood cells were counted using a hematology analyzer. Blood was centrifuged (100 g, 15 min, at room temperature) to obtain platelet-rich plasma (PRP). PRP was washed twice with buffer (pH 6.5), and the pellet was re-suspended in suspension buffer (pH 7.35); the platelet amount was adjusted to 2.5x103 platelets/μL. The platelet suspension was supplemented with 1 mol/L CaCl2 and centrifuged (14,000 g) at 4°C for degranulation. The supernatant, i.e. the platelet releasate, was retrieved. Male Lewis rats were sacrificed, their hearts isolated and perfused at constant pressure. Diluted platelet releasate (1:10) was infused into the isolated perfused rat hearts for 8 min followed by 2 min washout before 30/120 min global I/R. Infarct size (percentage of ventricular mass) was demarcated with staining by triphenyltetrazolium chloride. Data are presented as mean±SD. Results The platelet count was increased after RIPC, but unchanged after PLA (RIPC: from 204±19x103 platelets/μL to 247±16x103 platelets/μL; PLA: from 230±16x103 cells/μL to 222±18x103 platelets/μL; PLA vs. RIPC p<0.01, RIPC before vs. after p<0.01, two-way ANOVA for repeated measures with Fisher's least significant differences post-hoc tests), whereas all other blood cell counts remained unchanged. Infarct size was less with infusion of platelet releasate after RIPC in comparison to platelet releasate before RIPC and to platelet releasate before and after PLA, respectively (see Figure). Conclusion In response to RIPC in healthy volunteers, platelets carry soluble cardioprotective factor(s). Their precise nature must still be identified.


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