Same Day Subcutaneous ICD And Send Home
Phase: NA
Conditions: Cardiomyopathies, Cardiac Death, Sudden
Sponsor: Emile Daoud, MD

November 26, 2017 vs.1, February 21, 2018 vs.2, December 6, 2018 
 
 
 
Same Day Subcutaneous ICD And Send Home 
(DASH) 
 
 
 
Investigators: Toshimasa Okabe, M.D. 
 
Ross Heart Hospital at The Ohio State University Wexner Medical Center, 
Columbus, Ohio 
 
 
 
 

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Protocol Summary 
Title:  
 
Same Day Discharge Protocol for patients undergoing Subcutaneous  
                                    Implantable Cardioverter Defibrillator (S-ICD).                     
Design: 
Prospective, non-randomized single center study at The Ohio State 
University Wexner Medical Center. 
Purpose: 
The purpose of this study is to prospectively evaluate a specific 
analgesia protocol designed to allow for same day discharge following 
implantation of the S-ICD. 
Enrollment: 
Up to 50 subjects will be enrolled. 
Subject Population: Consecutive patients undergoing S-ICD implantation under general 
anesthesia or monitored anesthesia care. 
Endpoints:   
Rate 
of 
successful 
completion 
of 
the 
protocol; 
Procedural 
complications; Serial assessment of patient perception of pain. 
 
 
 

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BACKGROUND 
The number of subcutaneous implantable cardioverter-defibrillators (S-ICD) being 
implanted is steadily increasing; however, an important limitation to adoption of this 
technology is the perception for the need to admit patients overnight for pain management 
after device implantation.1 Furthermore, there is a great interest to perform more 
procedures in an outpatient setting so to reduce resource utilization and to minimize use of 
inpatient beds potentially available for other patients.  To date, there are no published 
studies regarding a protocol for outpatient management of patients undergoing 
implantation of S-ICD. At the Ohio State University Medical Center, we have implemented an 
institutional protocol to allow same-day discharge following S-ICD implantation, and S-ICD 
implantation is currently performed on an outpatient basis. The purpose, therefore, of this 
protocol is to complete a prospective evaluation of an outpatient analgesia protocol in 
consecutive patients undergoing S-ICD implantation.  
 
STUDY OBJECTIVES AND ENDPOINTS 
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. 

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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 
0-10 
3. Side effects related to medical therapy of protocol. 
4. Time from beginning of recovery (defined as when the patient enters the recovery 
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. 
 
STATISTICAL ANALYSIS 
The primary endpoint is rate of successful completion of device implantation and discharge 
of the patient on the same day that the S-ICD device is implanted.  The estimated success of 
the protocol is ≥85%. 
Although it is anticipated that the patient will be discharged about 3 hours post procedure, 
if the patient requires a longer period of time but then is discharged on the same day, this 
outcome would be considered a successful completion of the protocol.  Time from entry into 
the recovery area to the time of discharge will be collected.  Patients who are enrolled in the 
study and begin the protocol but then transition to being admitted overnight will be 
considered a failed protocol, even if the patient is discharged within 24 hours of the 

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procedure. The enrollment rate is expected to be 2 -3 patients per month for 18 months, with 
enrollment completed at the Ohio State University Wexner Medical Center (OSUWMC). 
In addition to the data collated to complete the primary and secondary endpoints, other data 
to be collected by the dedicated electrophysiology research nurse and anesthesia technician 
include: age, gender, body mass index, creatinine, etiology of cardiac disease, indication for 
S-ICD therapy (primary vs secondary prevention), episode of sustained ventricular 
tachycardia, episode of sudden cardiac arrest, New York Heart Association (NYHA)  Heart 
Failure Classification, left ventricular ejection fraction, the American Society of 
Anesthesiologists (ASA) classification, Mallampati score, presence of other comorbidities 
(valvular disease and if so which type, presence of congenital heart disease and if so which 
type, sleep apnea, pulmonary hypertension, chronic obstructive pulmonary disease, 
requirement for oxygen supplementation, chronic kidney disease, Eisenmenger's syndrome, 
atrial fibrillation/flutter, diabetes, hypertension, stroke, liver disease), and ambulatory 
medical therapy (beta blockers, calcium channel blockers, ACEI or ARBs, antiplatelet, 
anticoagulants and use of Class I, III antiarrhythmics or amiodarone, and pain medications).   
Intraoperative parameters to be collated are vital signs, oxygenation and carbon dioxide 
every 5 minutes from prior to induction until the patient leaves the implantation / 
electrophysiology laboratory following extubation, and duration of intubation.  Anesthestic 
parameters to be recorded are methods of induction, type and doses of inhaled and 
intravensous anesthetics and analgesics, as well as dose and type of local anesthetic.  The 
number of defibrillation testing and energy utilized will also be recorded. 
 
 

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STUDY DESIGN  
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. 
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. 

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• 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 
 
STUDY PROTOCOL 
Patient Identification & Consent 
Patients will be approached for participation in the study once they have been consented for 
implantation of the clinically indicated S-ICD.  Patients will be approached for participation 
by members of the electrophysiology staff, electrophysiology research team or by the 
anesthesiology team.  The protocol will be reviewed with the patient and if agreed, the 
patient will sign consent and begin the protocol before initiation of therapy for the S-ICD 
implantation.  As clinically indicated, a transthoracic echocardiogram or cardiac MRI will be 
reviewed for each patient. 
Study Protocol 
A multi-modal approach to analgesia is needed for timely discharge of patients after S-ICD 
implantation. The main criteria for discharge will be a combination of hemodynamic stability 
and adequate analgesia in the post-implantation period. 

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Assessment of Pain 
Pain assessment will be completed at defined points of care using the peer-reviewed pain 
perception scoring system, the 0-10 Numerical Pain Rating Scale (NPRS).2 The NPRS grades 
pain on a scale of 1 to10.  A pain score of 1 equates to mild pain, a pain score of 5 equates to 
moderate pain, and a pain score of 10 equates to severe pain score.2 Notably, the NPRS pain 
scoring system has been adopted for the assessment of pain after surgery at Ohio State 
University.  The pain perception tool is provided below: 
 
 
The Pain Perception Assessment questionnaire will be completed: 
1. Baseline – defined as completion of the pain perception scale on a day prior to the 
procedure or on the day of the procedure but before placement of an intravenous 
catheter. 
2. Within 1-2 hours post procedure while the patient is in recovery area. 
3. 1 day post implantation (phone call)  
4. 3 days post implantation (phone call) 
5. 2 weeks post implant (phone call) 

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6. At 30 days post implantation (in-person device check) at OSU device clinic 
 
Pre-Procedure 
Patients will arrive to the pre-/ post- procedure preparation and recovery area (“IPR unit”) 
about 2 hours prior to the start of the S-ICD implantation procedure.  The nursing staff will 
inquire if the patient has arranged for appropriate transportation home or to a hotel room 
and if there is a person who will be with the patient for about the first 12-18 hours post 
procedure.  If these parameters are not met and cannot be arranged before discharge, then 
the patient will not complete the study protocol and will be deemed a primary endpoint 
failure. 
If not already compliant with hospital policy, a history and physical will be completed by the 
electrophysiology and anesthesia team as well as laboratory work (CBC, Chem 6 and INR). A 
peripheral IV will be placed.  IV antibiotics in accordance with hospital protocol and to avoid 
allergic reaction will be administered.   
Pre-procedure analgesia will be given to each patient as follows:  
1. Acetaminophen 975 mg PO x 1 will be administered 1-2 hours prior to the procedure. 
2. Oxycodone 10 mg PO x 1 will be administered 1-2 hours prior to the procedure. 
Intra-Procedure 
The patient will undergo device implantation in one of the approved electrophysiology 
laboratory procedure rooms.  The choice of anesthetic will be at the discretion of the 

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attending anesthesiologist: monitored anesthesia care versus general anesthesia care.1,4,5,6  
Typically vital signs, airway assessment and oxygenation/carbon dioxide will be monitored 
and documented every 5 minutes.4,5 The left chest, axilla, subxyphoid and sternal regions 
will be prepped and draped in usual sterile manner.  The customary implantation technique 
will be the 2-incision approach followed by defibrillation testing at 65J.4,5 The goal is to have 
the S-ICD generator placed posteriorly in intimate contact with muscle along the chest wall 
and for the electrode to be directed vertically left of the left sternal border. The specific 
device implantation technique, however, will be at the discretion of the electrophysiologist 
to achieve optimal outcomes.  Fluoroscopy will be available and can be utilized at the 
discretion of the electrophysiologist.  
Local Anesthesia: The ideal local anesthetic for S-ICD implantation is yet to be determined. 
Most clinicians use 1% lidocaine with has a very rapid onset but a very short duration of 
action, and offers minimal post-procedure analgesia. Bupivacaine is a very long-acting local 
anesthetic which will provide significant post-implantation analgesia (6-8 hours); however, 
due its delayed onset of action of ~ 15 minutes, bupivacaine has not been adopted by most 
electrophysiologists.7,8,9 A combination of lidocaine and bupivacaine may be the best local 
anesthetic solution for S-ICD implantation to ensure rapid onset of anesthesia and prolonged 
analgesia.8,9 This combination of local anesthetics (lidocaine/bupivacaine solution) has a 
proven efficacy and safety margin.8,9 
- 
Create a 50:50 mixture of 2% lidocaine and 0.5% bupivacaine; which will 
result in a concentration of 1% lidocaine and 0.25% bupivacaine.8,9 
Administer 2.5 mg/kg (equivalent to 1 ml/kg) of the 50:50 solution of 2% 

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lidocaine and 0.5% bupivacaine for a field block at the pulse generator can and 
the parasternal lead tunneling sites. Considering that the maximum allowed 
dose of lidocaine is 4.5 mg/kg whereas the maximum allowed dose of 
bupivacaine is 3 mg/kg, the study patients will be dosed with 2.5 mg/kg which 
will allow a safety margin of 0.5 mg/kg for bupivacaine and 2.0 mg/kg for 
lidocaine.7  
 
Post-Procedure 
Patients will recover in IPR. Both the electrophysiologist and the anesthesiologist will assess 
patients for hemodynamic stability and adequate analgesia (pain score less than 5 or return 
to preoperative pain level in patients with chronic pain) before discharge. Vital signs will be 
documented approximately every 15 min x 4, every 30 minutes x 2 then, if no complications, 
prepare for discharge. In the IPR, choice of medications for pain control will be at the 
discretion of the attending anesthesiologist. 
 
Preparing for Discharge 
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.10 Patients with an Aldrete score ≥ 9 (score system described below) will 
be deemed eligible for discharge home.  

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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: 
1. 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.   

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Post Discharge Care  
The electrophysiology lab and device clinic nursing staff will contact the patient the 
following day, 3 days post discharge, and 14 days post discharge to administer the Pain 
Perception Questionnaire as well as to ask whether they have sought medical attention in 
the interim. The last Pain Perception questionnaire will be obtained at about 30 days post 
implantation during in-person device check at OSUMC device clinic. 
 
Study Risks 
Patients will receive the same care before, during, and after S-ICD implantation, including 
follow-up phone calls, regardless of whether they take part in this study. Therefore, there is 
no additional risk unique to this study beyond standard S-ICD implantation.  At our OSUMC, 
S-ICD implantations are already routinely performed on an outpatient basis without 
mandatory overnight hospitalization. Same-day discharge patients are managed for pain 
control as an outpatient in a similar manner as an inpatient.  Additionally, the 
hemodynamic parameters and the Aldrete score ≥ 9 are demonstrated to result in safe 
discharge of patients undergoing surgical procedures at OSUMC. 
 
The study protocol will be stopped early if: (1) the rehospitalization rate within 30 days of 
the procedure is >15%; and, (2) rehospitalization is deemed to be related to a complication 
from the S-ICD procedure attributable to being discharged on the same day of device 

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implantation and a complication that would have been avoided by having the patient remain 
in the hospital one night post device implantation.  
Publications 
The goal of this study is to produce 2 manuscripts.  One manuscript will focus upon the same 
day discharge protocol and will be submitted to an electrophysiology journal.  The second 
manuscript will focus upon the anesthesia aspects of care with data stratified by type of 
anesthesia (general vs monitored anesthesia care), and this manuscript will be submitted to 
an anesthesia journal. 
 
 

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References 
1. Gold, MR, Aasbo, JD, El-Chami, MF, et al., Subcutaneous implantable cardioverter-
defibrillator Post-Approval Study: Clinical characteristics and perioperative results. Heart 
Rhythm, 
E-pub 
ahead 
of 
print 
May 
11th, 
2017 
https://www.ncbi.nlm.nih.gov/pubmed/28502872. 
2. Ferreira-Valente MA, Pais-Ribeiro JL, Jensen MP. Validity of four pain intensity rating 
scales. Pain, 152(10):2399-404. 
4. Essandoh MK, Portillo JG, Weiss R, et al. Anesthesia care for subcutaneous implantable 
cardioverter/defibrillator placement: a single-center experience. Journal of Clinical 
Anesthesia, 2016. 31: p. 53-59. 
5. Essandoh MK, Otey AJ, Abdel-Rasoul M, et al. Monitored Anesthesia Care for Subcutaneous 
Cardioverter-Defibrillator Implantation: A Single-Center Experience. J Cardiothorac Vasc 
Anesth, 2016. 30(5): 1228-33. 
6. Afzal MR, Evenson BA, Patel D et al. Role of exercise electrocardiogram to screen for T-
wave oversensing after implantation of subcutaneous implantable cardioverter-
defibrillator. Heart Rhythm, 2017. S1547-5271(17)30769-5. doi: 10.1016. 
7. Barash PG, Cullen BF, Stoelting RK. Clinical anesthesia (7th edition). Philadelphia, PA: 
Wolters Kluwer Health/Lippincott Williams & Wilkins. 
8. Best CA, Best AA, Best TJ, et al. Buffered lidocaine and bupivacaine mixture – the ideal local 
anesthetic solution? Plast Surg 2015. 23(2):87-90. 

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9. Gadsden J. Local anesthetics: Clinical pharmacology and rational selection. 
http://www.nysora.com/local-anesthetics-clinical-pharmacology-and-rational-selection 
10. Aldrete JA. Modifications to the postanesthetic recovery score for use in ambulatory 
surgery. J Perianesth Nurs, 1998. 13(3): 148-55.