Awake Axillary Impella 5.5 Placement - A Feasibility Trial

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Cardiogenic Shock
• Intervention / Treatment: Procedure: Interscalene Block; Procedure: PECS II Block; Procedure: Superficial Cervical Plexus Block

Detailed Description

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Penn Presbyterian Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Treatment Arm; Patient in cardiogenic shock listed for Impella 5.5 placement who meets study inclusion criteria

Procedure: Interscalene Block; 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.; Other Names: Peripheral nerve block; Procedure: PECS II Block; 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.; Other Names: Peripheral nerve block; Pectoral Block; Fascial plane block; Procedure: Superficial Cervical Plexus Block; 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.; Other Names: Cervical plexus block; Peripheral nerve block

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: Abiomed Inc.
• Investigators: Principal Investigator: Asad Usman, MD, MPH, University of Pennsylvania; Principal Investigator: Marisa Cevasco, MD, MPH, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Actual): July 18, 2024

Study Registration Dates

• First Submitted: February 24, 2023
• First Submitted That Met QC Criteria: March 22, 2023
• First Posted (Actual): March 23, 2023

Study Record Updates

• Last Update Posted (Actual): July 19, 2024
• Last Update Submitted That Met QC Criteria: July 18, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: regional anesthesia; Cardiogenic shock; PECS II; Impella 5.5; Interscalene; Superficial Cervical
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; Shock; Shock, Cardiogenic
• Other Study ID Numbers: 852788; 77327727 (Other Grant/Funding Number: Abiomed)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No