EPi-Ease™ Epicardial Access Device

Equipment and Supplies

• EPi-Ease epicardial access device
• Fiberoptic light source
• Fiberoptic light cable
• Endoscope (2.9 mm x 315 mm – 330 mm, 30-degree view)
• Endoscopic camera/integrated coupler
• Camera control unit
• Fluoroscopy C-arm
• Vacuum source (minimum -400 mmHg) with tubing
• Video monitor
• Guidewire 0.014 inch/minimum 130 cm length/3-12 gram tip load

EPi-Ease Epicardial Access Procedure: Room Setup

Diagram showing room layout with personnel and equipment:

• C-arm
• Anesthesiologist
• Physician
• 1st Assistant
• Scrub
• Suction
• Camera/light
• Fluoro image, endoscopic image, monitoring/vitals

EPi-Ease Device Product Description

Description of the EPi-Ease device components:

• 1) Distal tip
• 2) Outer shaft
• 3) Handle
• 4) Endoscope/fiberoptic light cable*
• 5) Vacuum tubing with stopcock
• 6) Needle actuator
• 7) Guidewire port
• 8) Guidewire*
• 9) Camera unit*

*commercially available

EPi-Ease Device Set-Up

Device Components and Connections:

• Device 18F
• Vacuum connection: Start at -400 mmHg (max -600 mmHg)
• Endoscope*: 2.9 mm/9F diameter, 315-330 mm length, 30° view
• Guidewire*: 0.014 inch diameter, Minimum 130 cm length, 3-12 gram tip load
• Camera*
• Light cable*

*commercially available

Set-Up Steps:

• Prepare scope/camera/fiberoptic light cable assembly (4, 9).
• Load endoscope/fiberoptic light cable (4) and camera unit (9) into the EPi-Ease device.
• Connect the vacuum tubing with stopcock (5) to the vacuum source.
• Load guidewire into the guidewire port (7).

Camera/Scope Preparation

Attach the camera and fiberoptic light cable prior to insertion into the EPi-Ease device.

• Attach camera to endoscope
• Attach fiberoptic light cable to endoscope

Camera, Scope and Guidewire Preparation

• Attach the endoscope and camera to the EPi-Ease device.
• See images for proper insertion views: Posterior view, Superior view, Lateral view, Bottomed out view.
• Insert 0.014 inch guidewire into the guidewire port on the EPi-Ease device.

Guidewire inserted into guidewire port

Device Preparation

• Connect the vacuum tubing to the vacuum source.
• Ensure the stopcock is set to the “OFF” position during device insertion.
• Recommended starting vacuum pressure is –400 mmHg.
• DO NOT exceed –600 mmHg vacuum pressure.

EPi-Ease suction tubing and stopcock (OFF position)

EPi-Ease suction tubing and stopcock (ON position)

Ancillary Equipment

• Fiberoptic light source and camera control unit*
• Fiberoptic light cable*
• Endoscopic camera*
• Guidewire*: Diameter: 0.014 inch, minimum 130 cm length, 3-12 gram tip load
• Endoscope*: 2.9 mm/9F diameter: 315-330 mm length, 30 degree view
• Vacuum equipment*: Capable of -600 mmHg minimum

*commercially available

EPi-Ease: Procedural Steps

• EPi-Ease device and ancillary equipment are prepared (vacuum, light source, fiberoptic light cable, camera, endoscope, camera control unit, guidewire).
• Physician makes small subxiphoid incision. Incision should be at least 0.5 cm below the xiphoid or between 0.5 to 3 cm below the inferior aspect of the xiphoid depending on body habitus and/or anterior or posterior approach to obtain pericardial access.
• EPi-Ease device is inserted into the incision.
• EPi-Ease device is advanced to target epicardial site of interest. A location free of cardiac vessels and pericardial fat should be selected.
• EPi-Ease device is placed onto the pericardium, stopcock is opened to retract the pericardium and create a bleb.

EPi-Ease: Procedural Steps continued

• If device needs to be rotated to accommodate the chosen access site, always maintain camera orientation.
• Posterior approach: camera orientation facing up
• Anterior approach: camera orientation facing up
• Needle is advanced through the device to contact the pericardium. Ensure the needle actuator is pointing away from the pericardium (needle bevel is pointed away from the pericardium).
• Needle is carefully advanced further to puncture the pericardium.
• Guidewire is advanced through the needle until roughly 2-4 cm of guidewire has been introduced to the epicardial space. Check on fluoroscopy that the guidewire is outside of the distal tip.
• Vacuum is deactivated and needle is retracted, leaving only the guidewire in the epicardial space.
• Needle actuator is rotated 180 degrees allowing for further delivery of the guidewire (needle bevel points toward pericardium).
• Ensure guidewire is in epicardial space via fluoroscopy.
• EPi-Ease device is removed. Hold the guidewire in place to avoid losing access during device removal.