Clinical trial NCT05720936: In-hospital Stellate Ganglion Block for Arrhythmic Storm
Official title: A Multicenter Observational Study on In-hospital Stellate Ganglion Block for Arrhythmic Storm
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Arrhythmic Storm
Electrical Storm
Ventricular Fibrillation
Ventricular Tachycardia
Keywords: PSGB
L-PSGB
Percutaneous Stellate Ganglion Block
Percutaneous Stellate Ganglion Blockade
Electrical Storm
Lead sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
Sponsor class: OTHER
First posted: 2023-02-09
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.

Detailed description: This is an international multicenter observational retrospective and prospective short term (24 hours) longitudinal study, promoted and coordinated by the Fondazione IRCCS Policlinico San Matteo of 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:

* A previous history of cardiac sympathicectomy
* 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 Objectives:

The primary objective 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 objectives are:

1. The comparison of the number of shocks 12h before and 12h after the procedure
2. The feasibility of the procedure 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
3. The comparison of the effectiveness endpoint in patients with and without the appearance of anisocoria
4. The comparison of effectiveness between patients who will receive "anatomical" PSGB and those who will receive echo-guided PSGB
5. 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% (first step already achieved) and for 500 patients would be 2.6%.

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 (e-CRF). A personal and password protected account will be created for each investigator who will be able to access only to the data from his/her Center.

Eligibility criteria: Inclusion Criteria:

* age ≥ 18 years,
* 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.

Primary outcomes:
measure: reduction of arrhythmic relapses after PSGB
timeFrame: 12h before and 12h after the procedure
Secondary outcomes:
measure: reduction of arrhythmic relapses after PSGB
timeFrame: 12h before and 12h after the procedure
measure: complication rate related to PSGB
timeFrame: 12 hours after the procedure
measure: relationship between the appearance of anisocoria and the reduction of arrhythmic relapses after PSGB
timeFrame: 12h before and 12h after the procedure
measure: relationship between the approach used and the reduction of arrhythmic relapses after PSGB
timeFrame: 12h before and 12h after the procedure
measure: relationship between the administration type and the reduction of the arrhythmic relapses after PSGB.
timeFrame: 12h before and 12h after the procedure
Other outcomes:
Locations:
city: Alessandria
country: Italy
facility: A.O. SS. Antonio e Biagio e Cesare Arrigo di Alessandria.
state: AL
city: Bentivoglio
country: Italy
facility: Ospedale di Bentivoglio
state: BO
city: Bologna
country: Italy
facility: Ospedale Maggiore di Bologna
state: BO
city: Pavia
country: Italy
facility: Cardiology Department, Fondazione IRCCS Policlinico San Matteo
state: PV
city: Voghera
country: Italy
facility: Ospedale Civile
state: PV
city: Legnago
country: Italy
facility: Ospedale Mater Salutis
state: VR
city: Ancona
country: Italy
facility: A.O.U. delle Marche, Ospedali Riuniti
city: Asti
country: Italy
facility: Ospedale Cardinal Massaia
city: Bologna
country: Italy
facility: Policlinico S. Orsola-Malpighi, IRCCS A.O.U. Bologna
city: Cagliari
country: Italy
facility: P.O. "San Michele" dell'ARNAS "G. Brotzu" di Cagliari
city: Castellanza
country: Italy
facility: Istituto clinico Humanitas Mater Domini di Castellanza
city: Crema
country: Italy
facility: Ospedale Maggiore
city: Domodossola
country: Italy
facility: Ospedale San Biagio di Domodossola
city: Firenze
country: Italy
facility: Ospedale S. Maria Annunziata
city: Firenze
country: Italy
facility: P.O. Santa Maria Nuova e Palagi
city: Grosseto
country: Italy
facility: Ospedale Misericordia di Grosseto.
city: Gubbio
country: Italy
facility: Ospedale di Gubbio-Gualdo Tadino, USL Umbria 1
city: Ivrea
country: Italy
facility: Ospedale Civile di Ivrea
city: Lecco
country: Italy
facility: Ospedale Alessandro Manzoni
city: Livorno
country: Italy
facility: Azienda USL Toscana Nord Ovest, Presidio di Livorno
city: Messina
country: Italy
facility: A.O.U. Policlinico "G. Martino" di Messina.
city: Milano
country: Italy
facility: ASST Grande Ospedale Metropolitano Niguarda di Milano
city: Milan
country: Italy
facility: ASST Santi Paolo e Carlo
city: Milan
country: Italy
facility: IRCCS Ospedale San Raffaele
city: Milan
country: Italy
facility: Istituto Auxologico Italiano
city: Napoli
country: Italy
facility: Ospedale V. Monaldi - AOS dei Colli
city: Novara
country: Italy
facility: A.O.U. Maggiore della Carità di Novara
city: Padova
country: Italy
facility: Azienda Ospedale Università Padova
city: Perugia
country: Italy
facility: Ospedale S. Maria della Misericordia - Perugia
city: Rimini
country: Italy
facility: Ospedale "Infermi" AUSL Romagna
city: Roma
country: Italy
facility: A.O.U. Ospedale Sant'Andrea
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli, Università Cattolica del Sacro Cuore
city: Roma
country: Italy
facility: Fondazione PTV Policlinico Tor Vergata di Roma
city: Roma
country: Italy
facility: Ospedale Fatebenefratelli di Roma.
city: Savona
country: Italy
facility: Ospedale San Paolo
city: Torino
country: Italy
facility: Ospedale Molinette di Torino
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata - Verona
city: Lugano
country: Switzerland
facility: Istituto Cardiocentro Ticino
Study officials:
References:
citation: Savastano S, Schwartz PJ. Blocking nerves and saving lives: Left stellate ganglion block for electrical storms. Heart Rhythm. 2023 Jul;20(7):1039-1047. doi: 10.1016/j.hrthm.2022.11.025. Epub 2022 Dec 9.
citation: 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.
citation: 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.
citation: 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.
citation: 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. 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.