Dataset Information

Electrical storm treatment by percutaneous stellate ganglion block: the STAR study.

ABSTRACT:

Background and aims

An electrical storm (ES) is a clinical emergency with a paucity of established treatment options. Despite initial encouraging reports about the safety and effectiveness of percutaneous stellate ganglion block (PSGB), many questions remained unsettled and evidence from a prospective multicentre study was still lacking. For these purposes, the STAR study was designed.

Methods

This is a multicentre observational study enrolling patients suffering from an ES refractory to standard treatment from 1 July 2017 to 30 June 2023. The primary outcome was the reduction of treated arrhythmic events by at least 50% comparing the 12 h following PSGB with the 12 h before the procedure. STAR operators were specifically trained to both the anterior anatomical and the lateral ultrasound-guided approach.

Results

A total of 131 patients from 19 centres were enrolled and underwent 184 PSGBs. Patients were mainly male (83.2%) with a median age of 68 (63.8-69.2) years and a depressed left ventricular ejection fraction (25.0 ± 12.3%). The primary outcome was reached in 92% of patients, and the median reduction of arrhythmic episodes between 12 h before and after PSGB was 100% (interquartile range -100% to -92.3%). Arrhythmic episodes requiring treatment were significantly reduced comparing 12 h before the first PSGB with 12 h after the last procedure [six (3-15.8) vs. 0 (0-1), P < .0001] and comparing 1 h before with 1 h after each procedure [2 (0-6) vs. 0 (0-0), P < .001]. One major complication occurred (0.5%).

Conclusions

The findings of this large, prospective, multicentre study provide evidence in favour of the effectiveness and safety of PSGB for the treatment of refractory ES.

SUBMITTER: Savastano S

PROVIDER: S-EPMC10919918 | biostudies-literature | 2024 Mar

REPOSITORIES: biostudies-literature

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Publications

Electrical storm treatment by percutaneous stellate ganglion block: the STAR study.

Savastano Simone S Baldi Enrico E Compagnoni Sara S Rordorf Roberto R Sanzo Antonio A Gentile Francesca Romana FR Dusi Veronica V Frea Simone S Gravinese Carol C Cauti Filippo Maria FM Iannopollo Gianmarco G De Sensi Francesco F Gandolfi Edoardo E Frigerio Laura L Crea Pasquale P Zagari Domenico D Casula Matteo M Sangiorgi Giuseppe G Persampieri Simone S Dell'Era Gabriele G Patti Giuseppe G Colombo Claudia C Mugnai Giacomo G Notaristefano Francesco F Barengo Alberto A Falcetti Roberta R Perego Giovanni Battista GB D'Angelo Giuseppe G Tanese Nikita N Currao Alessia A Sgromo Vito V De Ferrari Gaetano Maria GM

European heart journal 20240301 10

<h4>Background and aims</h4>An electrical storm (ES) is a clinical emergency with a paucity of established treatment options. Despite initial encouraging reports about the safety and effectiveness of percutaneous stellate ganglion block (PSGB), many questions remained unsettled and evidence from a prospective multicentre study was still lacking. For these purposes, the STAR study was designed.<h4>Methods</h4>This is a multicentre observational study enrolling patients suffering from an ES refrac ...[more]

PMID: 38289867

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Project description:ImportanceThis is the first multisite, randomized clinical trial of stellate ganglion block (SGB) outcomes on posttraumatic stress disorder (PTSD) symptoms.ObjectiveTo determine whether paired SGB treatments at 0 and 2 weeks would result in improvement in mean Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total symptom severity scores from baseline to 8 weeks.Design, setting, and participantsThis multisite, blinded, sham-procedure, randomized clinical trial used a 2:1 SGB:sham ratio and was conducted from May 2016 through March 2018 in 3 US Army Interdisciplinary Pain Management Centers. Only physicians performing the procedures and the procedure nurses were aware of the intervention (but not the participants or assessors); their interactions with the participants were scripted and limited to the 2 interventions. Active-duty service members on stable psychotropic medication dosages who had a PTSD Checklist-Civilian Version (PCL-C) score of 32 or more at screening were included. Key exclusion criteria included a prior SGB treatment, selected psychiatric disorders or substance use disorders, moderate or severe traumatic brain injury, or suicidal ideation in the prior 2 months.InterventionsPaired right-sided SGB or sham procedures at weeks 0 and 2.Main outcomes and measuresImprovement of 10 or more points on mean CAPS-5 total symptom severity scores from baseline to 8 weeks, adjusted for site and baseline total symptom severity scores (planned a priori).ResultsOf 190 screened individuals, 113 (59.5%; 100 male and 13 female participants; mean [SD] age, 37.3 [6.7] years) were eligible and randomized (74 to SGB and 39 to sham treatment), and 108 (95.6% of 113) completed the study. Baseline characteristics were similar in the SGB and sham treatment groups, with mean (SD) CAPS-5 scores of 37.6 (11.2) and 39.8 (14.4), respectively (on a scale of 0-80); 91 (80.0%) met CAPS-5 PTSD criteria. In an intent-to-treat analysis, adjusted mean total symptom severity score change was -12.6 points (95% CI, -15.5 to -9.7 points) for the group receiving SGB treatments, compared with -6.1 points (95% CI, -9.8 to -2.3 points) for those receiving sham treatment (P = .01).Conclusions and relevanceIn this trial of active-duty service members with PTSD symptoms (at a clinical threshold and subthreshold), 2 SGB treatments 2 weeks apart were effective in reducing CAPS-5 total symptom severity scores over 8 weeks. The mild-moderate baseline level of PTSD symptom severity and short follow-up time limit the generalizability of these findings, but the study suggests that SGB merits further trials as a PTSD treatment adjunct.Trial registrationClinicalTrials.gov identifier: NCT03077919.

Project description:BackgroundIn patients with symptomatic cerebral vasospasm (CV) following aneurysmal subarachnoid hemorrhage who do not respond to medical therapy, urgent treatment escalation has been suggested to be beneficial for brain tissue at risk. In our routine clinical care setting, we implemented stellate ganglion block (SGB) as a rescue therapy with subsequent escalation to intraarterial spasmolysis (IAS) with milrinone for refractory CV.MethodsIn this retrospective analysis from 2012 to 2021, patients with CV following aneurysmal subarachnoid hemorrhage who received an SGB or IAS were identified. Patients were assessed through neurological examination and transcranial Doppler. Rescue therapy was performed in patients with mean cerebral blood flow velocity (CBFV) ≥ 120 cm/s and persistent neurological deterioration/intubation under induced hypertension. Patients were reassessed after therapy and the following day. The Glasgow Outcome Scale was assessed at discharge and 6-month follow-up.ResultsA total of 82 patients (mean age 50.16 years) with 184 areas treated with SGB and/or IAS met the inclusion criteria; 109 nonaffected areas were extracted as controls. The mean CBFV decrease in the middle cerebral artery on the following day was - 30.1 (± 45.2) cm/s with SGB and - 31.5 (± 45.2) cm/s with IAS. Mixed linear regression proved the significance of the treatment categories; other fixed effects (sex, age, aneurysm treatment modality [clipping or coiling], World Federation of Neurological Surgeons score, and Fisher score) were insignificant. In logistic regression, the presence of cerebral infarction on imaging before discharge from the intensive care unit (34/82) was significantly associated with unfavorable outcomes (Glasgow Outcome Scale ≤ 3) at follow-up.ConclusionsStellate ganglion block and IAS decreased CBFV the following 24 h in patients with CV. We suggest SGB alone for patients with mild symptomatic CV (CBFV < 180 cm/s), while subsequent escalation to IAS proved to be beneficial in patients with refractory CV and severe CBFV elevation (CBFV ≥ 180 cm/s).

Dataset Information

Electrical storm treatment by percutaneous stellate ganglion block: the STAR study.

Background and aims

Methods

Results

Conclusions

Publications

Electrical storm treatment by percutaneous stellate ganglion block: the STAR study.

Similar Datasets

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