Awake Axillary Impella 5.5 Placement - A Feasibility Trial

Study Overview
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Brief Summary
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The Abiomed Impella 5.5 is a surgically placed temporary mechanical support device used in patients in cardiogenic shock. The investigators propose using regional anesthesia (3 separate peripheral nerve blocks) to facilitate Impella 5.5 placement, a procedure which has traditionally been performed under a general anesthetic. Regional anesthesia is a proven and widely used technique to facilitate upper extremity vascular surgery cases (i.e. arteriovenous fistula creation). The investigators believe that employing these blocks in conjunction with intravenous sedation or monitored anesthesia care (MAC anesthesia) - a technique used in all types of cases, even in sick hearts during thranscatheter aortic valve replacements (TAVR) - will avoid the need increased doses of medications to support the blood pressure and cardiac output, avoid the need for post operative mechanical ventilation and intravenous sedation, and speed up the time to participating in physical therapy, time to heart transplant/durable mechanical support/recovery, and time to hospital discharge.

Detailed Description
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General anesthesia places patients who are in cardiogenic shock at risk for life threatening hemodynamic compromise due to the anesthetic and positive pressure ventilation, and confers the need for mechanical ventilation and sedation post operatively. Our hypothesis is that by utilizing regional anesthesia, anesthesiologists can facilitate surgical Impella placement with less risk of cardiovascular collapse with a faster road to recovery. By avoiding endotracheal intubation and concomitant heavy sedation both in the operating room and ICU, these patients will avoid worsening deconditioning and ICU delirium, with less days to physical therapy, ambulation, and recovery as compared to patients who undergo general anesthesia and remain ventilated in the ICU after their Impella placement. Patients scheduled for Impella 5.5 placement will be screened by a specific set of inclusion/exclusion criteria for potential participation in the study. If they consent, they will receive three commonly used upper extremity nerve blocks (Interscalene, PECS II, and superficial cervical plexus nerve blocks) and receive only intravenous sedation during the procedure.

Official Title
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Rapid Progression of Care in Cardiogenic Shock - Awake Surgical Placement of the Impella 5.5 Using Regional Anesthesia

Conditions
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Cardiogenic Shock

Intervention / Treatment
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* Procedure: Interscalene Block
* Procedure: PECS II Block
* Procedure: Superficial Cervical Plexus Block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Baseline Criteria: Agrees to procedure Excellent ultrasound images for nerve blocks Excellent ultrasound images for trans thoracic echo Age <60, BMI <30 Non hostile neck Evaluation of CT amenable to easy surgical access for Impella placement Meets criteria for MAC sedation: Able to lay relatively flat comfortably Able to understand and cooperate with procedures Easy airway (Mallampati I - II, prior grade 1-2 airway) Low risk of airway obstruction No high baseline oxygen requirement (over 6L/min) Meets criteria for regional anesthesia: Patient agrees to nerve block No active areas of infection around the block site No history of nerve damage or deficits in the area of the proposed nerve block No contralateral diaphragmatic paralysis or phrenic nerve palsy Exclusion Criteria: Does not wish to have MAC Does not wish to have Regional Anesthesia BMI > 30 Poor U/S windows for block or TTE Active infection over block area High Oxygen Requirement >6L NC Known or anticipated difficult airway Unable to lay flat comfortably Unable to cooperate or follow instructions

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: 10 patients in cardiogenic shock listed for Impella 5.5 placement
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Arm<br>Patient in cardiogenic shock listed for Impella 5.5 placement who meets study inclusion criteria | Procedure: Interscalene Block<br>* It is an ultrasound guided brachial plexus nerve block at roots/trunks used to anesthetize the shoulder and upper arm. Goal is to spread local anesthetic around superior and middle trunks of brachial plexus, between the anterior and middle scalene muscles.<br>* Other names: Peripheral nerve block;Procedure: PECS II Block<br>* PECS II block is comprised of two separate fascial plane blocks to anesthetize anterolateral chest wall using an ultrasound guided injection between the pectoralis major muscle and pectoralis minor muscle at third rib and a second ultrasound guided injection between pectoralis minor and serratus anterior. The goal is a high volume hydro dissection of the two fascial planes to anesthetize anterolateral chest wall and axilla.<br>* Other names: Fascial plane block;Procedure: Superficial Cervical Plexus Block<br>* This block is a superficial injection to the deep cervical fascia between the investing layer of the deep cervical fascia and the prevertebral fascia in the neck. This block provides anesthesia of the skin of the anterolateral neck and the ante-auricular and retro-auricular areas, as well as the skin overlying and immediately inferior to the clavicle on the chest wall. This is an ultrasound guided injection with the goal of placing the needle tip in the fascial layer underneath the SCM adjacent to the cervical plexus, which is contained within the tissue space between the Cervical fascia and posterior sheath of the SCM.<br>* Other names: Peripheral nerve block;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success of Using Regional Anesthesia for Impella 5.5 Placement | Number of patients that successfully undergo Impella 5.5. placement with the regional anesthesia protocol | Day of procedure (1 day) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to participation in physical therapy | Time from end of operation to getting out of bed or involving in physical therapy sessions | 6 weeks | 
| Time to destination therapy | Time to decision of heart transplant, ventricular assist device, or recovery | 6 weeks | 
| Sedation requirement | Total dose of sedatives required post operatively | 1 week | 
| Pain medication requirement | Total dose of pain medication required post operatively | 1 week | 
| Patient pain scores post operatively | The Numeric Pain Rating Scale score on post operative evaluations | 3 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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regional anesthesia, Impella 5.5, Cardiogenic shock, PECS II, Interscalene, Superficial Cervical