STAR: Iin-hospital Stellate Ganglion Block for Arrhythmic Storm
Study Details
Study Description
Brief Summary
Arrhythmic storm is a real emergency and its treatment could be challenging. Antiarrhythmic drugs are few and often ineffective. Neuromodulation has been grown in evidences but no large multicentric studies are present in literature about safety and effectiveness of Percutaneous Stellate Ganglion Block (PSGB). Patients with an electrical storm refractory to at least one antiarrhythmic drug will receive PSGB and will be enrolled in the present study.
The number of defibrillations before and after the treatment will be compared, complications will be annotated.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
This is a multicenter international observational retrospective and prospective short term (24 hours) longitudinal study, promoted and coordinated by the Fondazione IRCCS Policlinico San Matteo (Pavia, Italy).
Materials and methods All the patients who will meet the inclusion criteria will be enrolled in the study. Conscious patients with a sufficient free interval between arrhythmic relapses will sign the informed consent for the procedure and for data collection (attached at the study protocol) before the procedure. In case of unconscious patients the medical doctor will perform the procedure being in an emergency situation and the inform consent for data collection will be signed afterward once possible.
Inclusion criteria:
All the patients presenting with an arrhythmic storm defined as more than three sustained ventricular arrhythmias in 24 hours refractory to the standard medical treatment.
Exclusion criteria
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A previous history of cardiac sympathicectomy
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Having a neck judged by the doctor as non-suitable for the procedure (previous neck surgery, previous burns, presence of large scars, thyroid goiter)
PSGB technique
Both the two approaches present in literature and commonly used for this technique are allowed for the study:
-
The "anatomical" approach which consist in the identification of the Chassaignac's tubercle that represents the point of needle insertion
-
The "echo-guided" approach Regardless to the approach (anatomical or echo-guided) the doctor will be able to choose, according to the clinical characteristics of the patients, whether to perform a single shot injection of anesthetic or a continuous infusion of anesthetic. In the second case a catheter will be left in place and connected to an infusion pump.
Study endpoints The primary endpoint is the effectiveness of the PSGB expressed by the reduction of arrhythmic relapses [number of Direct Current (DC) shocks or Anti-Tachycardia Pacing ATP] in the 12 hours immediately after the PSGB as compared to the 6 hours immediately preceding the PSGB of at least 50%.
The secondary endpoints are:
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The comparison of the number of shocks 12h before and 12h after the procedure
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The feasibility of the procedure expressed as the number of complications within 12 hours from the procedure. The following complications will be considered:
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Simple hematoma
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Symptoms due to anesthetic absorbance
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Hematoma requiring intervention
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Intravascular injection without complication
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Intravascular injection with complication
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Brachial plexus damage
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Simple vascular damage
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Vascular damage requiring intervention
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The comparison of the effectiveness endpoint in patients with and without the appearance of anisocoria
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The comparison of effectiveness between patients who will receive "anatomical" PSGB and those who will receive echo-guided PSGB
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The comparison of effectiveness between patients who will receive anaesthetic infusion in the site of PSGB as compared to those who will not.
Statistics Sample size: The investigators plan to enroll patients satisfying the inclusion/exclusion criteria over a time horizon of 5 years. Based on our previous experience over the previous 18 months (enrollment of 8 patients) about 5 patients per year are though to be enrolled, thus reaching a sample size 33 patients in the Pavia Center. The success is effectiveness to be not less then 90%, based on our historical cohort. This will yield a confidence interval of 76% to 98%, corresponding to a precision of 11%. Also, with this sample size it will be able to exclude an effectiveness of 70% (considered as the lower bound of acceptability) with a power of 94% (alpha 2-sided 5%).
With the inclusion of further centers, the increased sample size will allow an increased precision of the estimates; for instance for 100 patients precision would be 6.5%.
Statistical analysis: Data will be described with the mean and standard deviation or the median and 25th-75th percentile if continuous and counts and percent if categorical.
For the analysis of the primary endpoint the rate of effectiveness together with its 95% exact binomial confidence interval will be computed.
Data management Data will be collected using the REDCap platform. A personal and password protected account will be created for each investigator who will be able to access only to the data form his/her center.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| patients with electric storm patients with electric storm defined as the occurrence of at least three episodes of ventricular fibrillation/tachycardia in 24 hours |
Procedure: Percutaneous stellate ganglion block (PSGB)
Both the two approaches present in literature and commonly used for this technique are allowed for the study:
The "anatomical" approach which consist in the identification of the Chassaignac's tubercle that represents the point of needle insertion
The "echo-guided" approach
|
Outcome Measures
Primary Outcome Measures
- reduction of arrhythmic relapses after PSGB [12h before and 12h after the procedure]
effectiveness of the PSGB expressed by the reduction of arrhythmic relapses (number of DC shocks or anti-tachycardia pacing ATP) of at least 50% after PSGB.
Secondary Outcome Measures
- reduction of arrhythmic relapses after PSGB [12h before and 12h after the procedure]
the effectiveness of the technique will be evaluated by the comparison of the number of shocks before and after the procedure
- complication rate related to PSGB [12 hours after the procedure]
The feasibility of the procedure will be expressed as the number of complications within 12 hours from the procedure. The following complications will be considered: Simple hematoma Symptoms due to anesthetic absorbance Hematoma requiring intervention Intravascular injection without complication Intravascular injection with complication Brachial plexus damage Simple vascular damage Vascular damage requiring intervention
- relationship between the appearance of anisocoria and the reduction of arrhythmic relapses after PSGB [12h before and 12h after the procedure]
The comparison of the effectiveness endpoint in patients with and without the appearance of anisocoria
- relationship between the approach used and the reduction of arrhythmic relapses after PSGB [12h before and 12h after the procedure]
The comparison of effectiveness between patients who will receive "anatomical" PSGB and those who will receive echo-guided PSGB.
- relationship between the administration type and the reduction of the arrhythmic relapses after PSGB. [12h before and 12h after the procedure]
The comparison of effectiveness between patients who will receive continuous anesthetic infusion and patients who will receive a single bolus in the site of PSGB.
Eligibility Criteria
Criteria
Inclusion Criteria:
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age ≥ 18 years,
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presence of arrhythmic storm defined as more than three sustained ventricular arrhythmias in 24 hours refractory to the standard medical treatment.
Exclusion Criteria:
-
A previous history of cardiac sympathicectomy
-
Having a neck judged unsuitable for the procedure (previous neck surgery, previous burns, presence of large scars, thyroid goiter)
Both the two approaches present in literature and commonly used for this technique are allowed for the study:
-
The "anatomical" approach which consist in the identification of the Chassaignac's tubercle that represents the point of needle insertion
-
The "echo-guided" approach Regardless to the approach (anatomical or echo-guided) the doctor will be able to choose, according to the clinical characteristics of the patients, whether to perform a single shot injection of anesthetic or a continuous infusion of anesthetic. In the second case a catheter will be left in place and connected to an infusion pump.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | A.O. SS. Antonio e Biagio e Cesare Arrigo di Alessandria. | Alessandria | AL | Italy | |
| 2 | Ospedale Maggiore di Bologna | Bologna | BO | Italy | |
| 3 | Fondazione IRCCS Policlinico San Matteo | Pavia | PV | Italy | 27100 |
| 4 | P.O. "San Michele" dell'ARNAS "G. Brotzu" di Cagliari | Cagliari | Italy | ||
| 5 | Istituto clinico Humanitas Mater Domini di Castellanza | Castellanza | Italy | ||
| 6 | Ospedale San Biagio di Domodossola | Domodossola | Italy | ||
| 7 | Ospedale Misericordia di Grosseto. | Grosseto | Italy | ||
| 8 | A.O.U. Policlinico "G. Martino" di Messina. | Messina | Italy | ||
| 9 | ASST Grande Ospedale Metropolitano Niguarda di Milano | Milano | Italy | ||
| 10 | A.O.U. Maggiore della Carità di Novara | Novara | Italy | ||
| 11 | Ospedale S. Maria della Misericordia - Perugia | Perugia | Italy | ||
| 12 | Fondazione PTV Policlinico Tor Vergata di Roma | Roma | Italy | ||
| 13 | Ospedale Fatebenefratelli di Roma. | Roma | Italy | ||
| 14 | Ospedale Molinette di Torino | Torino | Italy | ||
| 15 | Azienda Ospedaliera Universitaria Integrata - Verona | Verona | Italy | ||
| 16 | Istituto Cardiocentro Ticino | Lugano | Switzerland |
Sponsors and Collaborators
- IRCCS Policlinico S. Matteo
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- Savastano S, Baldi E, Camporotondo R, Belliato M, Marinoni B, De Ferrari GM. Percutaneous stellate ganglion block and extracorporeal cardiopulmonary resuscitation: an effective and safe combination for refractory ventricular fibrillation. Europace. 2020 Jan 1;22(1):148. doi: 10.1093/europace/euz180. No abstract available.
- Savastano S, Dusi V, Baldi E, Rordorf R, Sanzo A, Camporotondo R, Fracchia R, Compagnoni S, Frigerio L, Oltrona Visconti L, De Ferrari GM. Anatomical-based percutaneous left stellate ganglion block in patients with drug-refractory electrical storm and structural heart disease: a single-centre case series. Europace. 2021 Apr 6;23(4):581-586. doi: 10.1093/europace/euaa319.
- Savastano S, Pugliese L, Baldi E, Dusi V, Tavazzi G, De Ferrari GM. Percutaneous continuous left stellate ganglion block as an effective bridge to bilateral cardiac sympathetic denervation. Europace. 2020 Apr 1;22(4):606. doi: 10.1093/europace/euaa007. No abstract available.
- Savastano S, Schwartz PJ. Blocking nerves and saving lives: Left stellate ganglion block for electrical storms. Heart Rhythm. 2022 Dec 9:S1547-5271(22)02695-9. doi: 10.1016/j.hrthm.2022.11.025. Online ahead of print.
- Zeppenfeld K, Tfelt-Hansen J, de Riva M, Winkel BG, Behr ER, Blom NA, Charron P, Corrado D, Dagres N, de Chillou C, Eckardt L, Friede T, Haugaa KH, Hocini M, Lambiase PD, Marijon E, Merino JL, Peichl P, Priori SG, Reichlin T, Schulz-Menger J, Sticherling C, Tzeis S, Verstrael A, Volterrani M; ESC Scientific Document Group; Cikes M, Kirchhof P, Abdelhamid M, Aboyans V, Arbelo E, Arribas F, Asteggiano R, Basso C, Bauer A, Bertaglia E, Biering-Sorensen T, Blomstrom-Lundqvist C, Borger MA, Celutkiene J, Cosyns B, Falk V, Fauchier L, Gorenek B, Halvorsen S, Hatala R, Heidbuchel H, Kaab S, Konradi A, Koskinas KC, Kotecha D, Landmesser U, Lewis BS, Linhart A, Lochen ML, Lund LH, Metzner A, Mindham R, Nielsen JC, Norekval TM, Patten M, Prescott E, Rakisheva A, Remme CA, Roca-Luque I, Sarkozy A, Scherr D, Sitges M, Touyz RM, Van Mieghem N, Velagic V, Viskin S, Volders PGA. 2022 ESC Guidelines for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death. Eur Heart J. 2022 Oct 21;43(40):3997-4126. doi: 10.1093/eurheartj/ehac262. No abstract available.
- STAR Study