Same Day Subcutaneous ICD And Send Home (DASH)

This is a prospective, nonrandomized, descriptive, single center study designed to assess the
rate of successful completion of the study protocol in consecutive patients undergoing S-ICD
implantation.

Objectives To prospectively evaluate the same day discharge protocol for patients undergoing
S-ICD implantation.

Primary Endpoint 1. Rate of successful completion of S-ICD implantation and discharge of the
patient on the same day the device is implanted using the analgesia protocol.

Secondary Endpoints

1. Procedure complication (failed implantation, infection, hematoma/bleeding, etc…) within
30 days of procedure.

2. Serial assessment of patient perception of pain using the graded integer pain scale of
1-10

3. Side effects related to medical therapy of protocol.

4. Time from beginning of recovery (defined as when the patient enters the recovery IPR
room) to the time of discharge from the recovery unit.

5. 30 day readmission rate after discharge following S-ICD implant

6. Number of days that oral analgesics are used post discharge.

Patients will be approached for participation in the study once they have been consented for
implantation of the clinically indicated S-ICD

Pre-procedure analgesia will be given to each patient as follows:

Acetaminophen 975 mg PO x 1 will be administered 1-2 hours prior to the procedure. and
Oxycodone 10 mg PO x 1 will be administered 1-2 hours prior to the procedure. Anesthesia will
be provided by anesthesiology team as MAC or general anesthesia. Local subcutaneous
anesthetic will be a 50:50 mixture of 2% lidocaine and 0.5% bupivacaine; which will result in
a concentration of 1% lidocaine and 0.25% bupivacaine.

Starting at ≈2 hours post procedure, the patient will then enter the "Preparation for
Discharge" phase. The modified Aldrete scoring system will be used to determine eligibility
for discharge home.Patients with an Aldrete score ≥ 9 will be deemed eligible for discharge
home.

Additional standard ambulatory discharge criteria per the OSUWMC postanesthesia care policy
statement will be applied by the nursing team, akin to all ambulatory surgery patients at
OSUWMC. If the above discharge parameters (DP) are not meet, the patient will be reassessed
every 30 minutes until parameters are satisfied. Once the patient satisfies the DP, the
patient will complete the Pain Perception Questionnaire and be assessed for ambulation,
eating/drinking and for understanding of post discharge instructions. The electrophysiology
device nursing staff will review management of the S-ICD incision, device and post discharge
care instructions with the patient and with the accompanying family member(s)/friend. The
patient will be given instructions regarding management of pain and will be provided the
following prescription for outpatient pain control Percocet 5mg/325 mg (1 tablet every 6
hours). A 2-day supply will be given.

Also, the patient will be provided a phone number to contact during business hours as well as
for after hours to address questions/concerns.

The electrophysiology nursing staff will contact the patient the following day and again at
about 3 days post discharge to administer the Pain Perception Questionnaire as well as to
address any patient questions. The patient will then be evaluated in the Device Clinic about
10 days post implantation. The Pain Perception questionnaire will be administered and
assessment of the incision and S-ICD will be completed. The last Pain Perception
questionnaire will be obtained by telephone at about 30 days post implantation.

Inclusion Criteria:

- Patient consented for implantation of S-ICD.

- Ambulatory/outpatient patient coming to the hospital setting solely for implantation
of S-ICD

- Patient agrees to participate and is able to comply with the defined study protocol,
including assistance for home care and transportation for the first ≈12-18 hours post
discharge, and compliance with the required follow up.

Exclusion Criteria:

- Inability or unwillingness to provide informed consent

- Patients who, for any reason, was hospitalized or in an emergency department the day
prior to the S-ICD implantation, including patients transferred for S-ICD implantation

- Patients in which the hemodynamics are dependent upon intravenous pressors infusing at
the time of device implantation or mechanical support, inclusive of left ventricular
assist device and intravenous devices (balloon pump, Impella device).

- Age < 18 years.

- Pregnancy.

- Currently incarcerated.

- Hypoxia (room air oxygen <91%) or acutely short of breath.

- Hypotension (Systolic blood pressure <90) unless this is patient's typical blood
pressure).

- Bradycardia (heart rate <45bpm, unless this is patient's typical resting heart rate).

- Acute electrolyte disorder that cannot be easily corrected (e.g., potassium
supplementations) based upon Chem 6 values obtained on day of procedure.

- Presence of a fever.