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	�:	Propofol administration by electrophysiologist versus an anesthesiologist during cardiac resynchronization therapy-defibrillator (CRT-D) implantation: Is an anesthesiologist necessary?
Omar I. Mufti, MD *
Muhammad B. Quraishi, MD �
Mohammad A. Kabir, MD�
Ronald Markert, PhD *
Abdul Wase, MD, FACC, FHRS *�
Total Words: 3,147 
*Wright State University Boonshoft School of Medicine, Dayton, Ohio
�Kettering Medical Center, Dayton, Ohio
�Good Samaritan Hospital, Dayton, Ohio
No grants, contracts, or financial support was used during the process of our study.
There are no relationships to industry either.


Abstract
Background: It is recommended that propofol be administered by an anesthesiologist. We examined whether propofol could be administered with equal safety under the supervision of an electrophysiologist. The reference procedure was cardiac resynchronization therapy-defibrillator (CRT-D) implantation, which requires deep sedation at the time of defibrillation threshold (DFT) testing.
Methods: We studied 250 consecutive patients who underwent CRT-D implantation under anesthetist (Anesth directed) supervision at Good Samaritan Hospital, Dayton, Ohio (GSH, n=169) and under electrophysiologist (EP directed) supervision at St. Rita�s Medical Center, Lima, Ohio (SRMC, n=81) between 2001 and 2008. In both groups patients received sedation using boluses of 1-2mg of midazolam and 25-50 mcg of fentanyl intravenously and propofol for DFT testing. Dose adjustments were based on age, respiratory status and comorbidities.
Results: Age (70.4�11.1 vs 69.3�10.6) and left ventricular ejection fraction (0.24�0.07 vs 0.22 �0.07) were similar for the EP and Anesth directed groups, respectively. The EP directed group received a lower mean dosage of propofol (53.7�25.3 mcg vs 68.3�33.5 mcg), [p=0.001], had a greater mean body surface area (2.66�0.40 sq m vs 2.03�0.26 sq m), [p<0.001], and shorter mean duration of procedure (105�45 min vs 148�64 min), [p <0.001]. No procedural deaths occurred, and no significant differences were noted in anesthetic complications between the groups. 
Conclusion: Propofol administration before DFT testing for CRT-D is safe when administered either by an anesthesiologist or under supervision of an electrophysiologist; however, duration of the procedure was significantly longer when an anesthesiologist was involved.
Key Words: Propofol; Electrophysiologist; Cardiac resynchronization therapy-defibrillator; AnesthesiologistPropofol administration by electrophysiologist versus an anesthesiologist during cardiac resynchronization therapy-defibrillator (CRT-D) implantation: Is an anesthesiologist necessary?
Omar Idris Mufti, MD, Muhammad Bilal Quraishi, MD, Mohammad Anwarul�Kabir,�MD  Ronald Markert, PhD, Abdul Wase, MD, FACC, FHRS
Introduction
Background
Propofol is an ultra-short acting sedative/hypnotic agent without analgesic property. It is commonly used in combination with midazolam and/or fentanyl for induction of anesthesia for procedures in the cardiac catheterization/electrophysiology lab. The drug is safe and effective when used with caution. Propofol administration is associated with significant hypotension but has a short pharmacologic effect with smooth recovery. Since propofol has no reversal agent, its use is limited to administration by trained personnel. The use of propofol in the endoscopy lab has been demonstrated to be cost effective with improved practice efficiency when used by a non-anesthesiologist [1].
Limited data are available on the safety of propofol administration during defibrillation threshold (DFT) testing by an electrophysiologist when compared to its administration with an anesthesiologist. Furthermore, data are not available on intravenous bolus administration of propofol just before DFT testing among patients who concomitantly received midazolam and fentanyl for hypnosis, amnesia and analgesia. The presence of monitored anesthesiology care for sedation purposes during electrophysiology procedures maybe hard to attain in many institutions. 
We choose to only evaluate implantation of cardiac resynchronization therapy-defibrillator (CRT-D) because this was the sickest patient population. These patients had the lowest ejection fraction, functional class, and many associated co-morbid conditions.
Objective
We sought to compare differences in outcomes when propofol is administered by an electrophysiologist as compared to its use by anesthesiologist/nurse anesthetist during CRT-D implantation just before DFT testing.
Methods
This retrospective observational study was designed to review 250 consecutive patients who underwent CRT-D implantation  under anesthetist (Anesth directed) supervision at Good Samaritan Hospital Dayton, OH (GSH n=169) and under electrophysiologist (EP directed)  supervision at St. Rita�s Medical Center, Lima, OH (SRMC n=81) between 2001 and 2008.  Patients younger than 18 years of age were excluded from the study.
A single electrophysiologist implanted CRT-D at SRMC and the same electrophysiologist implanted majority of the devices at GSH. 
GSH�s Human Investigation Review Committee and SRMC�s Institutional Review Board approved the study protocol and the study was conducted under their supervision. Patients underwent CRT-D implantation in the electrophysiology laboratory at GSH and the cardiac catheterization laboratory at SRMC.
Data Collection
The data were collected through chart and procedure log review during CRT-D implantation and DFT testing. Dosing information and duration of procedure were obtained via the procedure logs. Respiratory complications requiring assisted ventilation and intubation were also obtained in the same manner. The data were gathered by two investigators (OM, MBQ) who were not involved in the procedure.
Inclusion Criteria:
Congestive Heart Failure (CHF) patients who qualified for CRT-D implantation and met the following criteria were included in the study:
1. Chronic systolic heart failure New York Heart Association (NYHA) Functional Class III to IV 
2. Ischemic cardiomyopathy with a left ventricular ejection fraction (LVEF) of d" 35% 
3. Non-ischemic cardiomyopathy with a LVEF < 30% or non-ischemic cardiomyopathy with heart failure and a LVEF d" 35%
4. Intraventricular conduction delay (left or right bundle branch block or paced) with QRS duration e" 120 msec 
5. Optimal heart failure medical therapy
Exclusion Criteria:
Recent myocardial infarction within 40 days
Recent revascularization by either percutaneous coronary intervention or coronary artery bypass grafting within the last 90 days
Estimated survival of less than one year
Patients who underwent CRT-D implantation but were deemed to be too sick for sedation due to poor American Society of Anesthesiologists (ASA) classification or Mallampati class, or patients were not candidates for induction of ventricular fibrillation (VF) due to advanced cardiomyopathy.

Details of the Procedure
Patients underwent assessment for the risk of anesthesia by Mallampati and ASA classification. Heart rate (HR), blood pressure (BP), oxygen (O2) saturation, and level of consciousness were assessed every two minutes. Patients were initially sedated with 1-2 milligrams (mg) boluses of midazolam, and analgesia was achieved with intravenous administration of 25-50 micrograms (mcg) of fentanyl. The doses were repeated based on the patient�s response. Prior to DFT testing, propofol was administered by an anesthesiologist or nurse anesthetist at GSH while an electrophysiologist administered the drug at SRMC, where a dedicated respiratory therapist trained in endotracheal intubation managed the airway. The anesthesiologist or nurse anesthetist was present only during DFT testing and initial conscious sedation was administered by the electrophysiologist.
Initially, a dose of 1 mg/kg of propofol was administered intravenously. Adjustment in dosage was made based on age, respiratory status, and co-morbid conditions. If the patient was still awake, a repeat dose of 0.5 mg/kg was administered followed by 0.25 mg/kg as needed. The efficacy of sedation was achieved when there was loss of eye lash reflex and loss of response to gentle shaking, after the administration of intravenous propofol.
Dosages for drugs, duration of induction, and total duration of the procedure were collected. The duration of the procedure was defined as time from incision to the time when the patient first responded to verbal commands. A predefined scoring system was used to assess the patient�s response. Achievement of a Steward score of 6 was used to delineate the end of the procedure [2]. The details of the scoring system for the Steward Score are shown in Figure 1 [2]. 
Respiratory arrest was defined as rapidly declining oxygen saturations despite adequate oxygenation requiring intubation or temporary assisted ventilation determined by the anesthesiologist or respiratory therapist. The use of a reversal agent for impending respiratory arrest was considered a complication. 
DFT testing was performed by induction of VF via shock on T wave or the �high fib� method. An initial energy of 15 Joules was arbitrarily chosen, and if successful at conversion, the value was accepted as �defibrillation threshold�. If unsuccessful, the step-up protocol was used in which the first defibrillation was attempted at 15 Joules and if unsuccessful was increased by increments of 10 Joules until the patient was successfully defibrillated.
Statistical Analysis
Continuous variables were expressed as mean � standard deviation (SD) and categorical variables as counts and percents.  The two groups (Anesth directed vs. EP directed) were compared by using Student�s t-test for continuous variables and the chi square test or Fisher�s Exact Test for categorical variables. All inferential analyses used two-sided p values with significance if less than or equal to 0.05. Data were analyzed with IBM SPSS Statistics 20.0 (IBM SPSS, Inc., Armonk, NY).
Results
Two hundred and fifty consecutive patients, 81 (32.4%) from Anesth directed and 169 (67.6%) from EP directed group, were included in the study with none lost to follow-up. The mean age at the two sites did not differ (70.4�11.1 at EP directed vs 69.3�10.6 at Anesth directed, p = 0.42), nor were there a difference by sex (EP directed males = 69%, Anesth directed males = 74%, p = 0.42).  With EP directed being a rural setting and Anesth directed an urban setting, it was not surprising that the Anesth directed sample had fewer Caucasians (Anesth directed= 80%, EP directed = 96%, p = 0.001).   Table 1 reports the demographic and clinical characteristics at both sites
The mean body surface area (BSA) of the EP directed group was higher than the Anesth directed group (2.66�0.40 vs 2.03�0.28, p<0.001).  The two groups did not differ in LVEF (EP directed = 23.9%�7.4% vs 22.5%�6.9%, p = 0.15) or presence of ischemic cardiomyopathy (EP directed = 72%, Anesth directed = 60%, p = 0.07). The two groups had a similar prevalence of diabetes mellitus (EP directed = 41%, Anesth directed= 42%, p = 0.85) and COPD (EP directed = 22%, Anesth directed = 26%, p = 0.51). The mean glomerular filtration rate (eGFR) was higher in the EP directed group (EP directed = 65.3�26.6, Anesth directed = 57.0�22.1, p = 0.01). 
The use of amiodarone (EP directed = 20% vs Anesth directed = 20%, p = 0.97), digoxin (EP directed = 56% vs Anesth directed = 56%, p = 0.92), and angiotensin-converting-enzyme inhibitors (ACEI) or angiotensin receptor blockers (ARB) (EP directed = 75% vs Anesth directed= 74%, p = 0.82) was similar in both groups.  However, the use of beta-blockers (EP directed= 95% vs Anesth directed = 86%, p = 0.039) and diuretics (EP directed = 65% vs Anesth directed = 40%, p < 0.001) was higher in the EP directed group. 
Medications used for conscious and deep sedation are reported in Table 2.  The mean dose of fentanyl (EP directed = 141.1�84.8 mcg vs Anesth directed = 108.9�59.2 mcg) was marginally higher in the EP directed group (p = 0.064).  The mean dose of midazolam (EP directed = 5.68�3.37 mg vs Anesth directed = 4.10�2.46 mg, p = 0.004) was higher in the EP directed while the mean propofol dose in the Anesth directed group was higher than the EP directed (Anesth directed = 68.3�33.5 mg, EP directed = 53.7�25.3 mg, p = 0.001).  Finally, the mean duration of the procedure is reported in Table 2.  Procedures took longer in the Anesth directed group (EP directed = 105.4�45.2 minutes vs Anesth directed = 147.9�64.2 minutes, p < 0.001). 
No procedural deaths occurred in either of the two groups, and no significant differences were noted in anesthetic complications. Reversal agents were used in four patients; all in the Anesth directed group. Four patients, two in each group, required temporary assisted ventilation; however, only one patient (Anesth directed) required endotracheal intubation.
Discussion
Our findings suggest that administration of propofol by an electrophysiologist is as safe as administration by an anesthesiologist.  The BSA was higher in the EP directed group; however, they received larger doses of midazolam and fentanyl, but lower doses of propofol. The duration of the procedure was shorter in the EP directed group compared to Anesth directed.
Adverse events were few, perhaps due to the low dosage of propofol at both sites. (53.7�25.3 mg and 68.3�33.5 mg in the EP and Anesth directed groups, respectively).  In contrast, Safyo [3] reported a mean propofol dose per procedure of 459�400 mg, a markedly different average dose more than seven times greater than with our patients. 
Our study has limitations.  First, while we believe the patient data in our study were accurate and gathered with care, retrospective studies such as ours generally are more susceptible to data errors than prospective studies. Also, no mechanism was in place to assess inter-rater reliability.  Second, while the two groups were unequal in number of patients (approximately two-thirds from Anesth directed), the sample size in the smaller group (EP directed = 81) is sufficiently large to be representative of an urban hospital setting. Third, the mean BSA was higher at one hospital (EP directed), and the doses of midazolam and fentanyl administered were also higher.  These latter two differences may account for the lower doses of propofol and shorter duration of procedure in the EP directed group.  Fourth, ASA and Mallampati scores were not available for all subjects of the study.  Therefore, baselines differences in regards to ASA and Mallampati scores cannot be accounted which may have influenced the results. Fifth, capnography was not the standard of care at the initiation of this study and hence was not used for monitoring during the administration of sedation.  However, this may have not impacted the outcomes of the study due to low complication rates. Sixth, our sample may not have been representative of the population of patients who have CRT-D implantation since the sickest patients did not undergo DFT testing and thus were excluded from the study.   Finally, one electrophysiologist administered conscious and deep sedation in the EP directed group compared to multiple anesthesia specialists in the Anesth directed group.  
Earlier studies performed CRT-D implantation and DFT testing under general anesthesia [4]. The duration and dose of anesthetics have no impact on DFT testing [5]. Antonio and colleagues demonstrated that CRT-D implantation could be safely performed under conscious and deep sedation when administered by an anesthesiologist [6]. Later studies indicated that single chamber ICDs can be safely implanted by electrophysiologists without administration of general anesthesia and in the absence of an anesthesiologist [7,8]. Nurse administered conscious sedation has also been shown to be safe in the EP laboratory [9,10].   A survey conducted by the Mayo Clinic suggested that the presence of an anesthesiologist was warranted in most cases. However, this questionnaire was limited by poor response, as only 40% of the 95 academic electrophysiology programs surveyed responded [11]. There is no definitive consensus as to whether the presence of an anesthesiologist is warranted for conscious and deep sedation when an electrophysiologist is to perform CRT-D implantation.  Our findings are similar to those of Kezerashvili et al and Sayfo et al, who demonstrated the safety of conscious and deep sedation with intermittent boluses of propofol [1,3]. 
Interestingly, our study employed respiratory therapist instead of nurses for endotracheal intubation. This is in contrast to previous studies where trained nurses were involved in providing respiratory support [12]. This could potentially provide the basis of a less expensive method of respiratory care during implantation procedures.
Conclusion
This study contributes to the rapidly emerging evidence base concerning non-anesthesiologist administered propofol during electrophysiology procedures, which further supports the requirement of more rigorous examinations in the field to determine which sedation strategy produces the most optimal patient outcomes in this challenging context.



References
1. Kezerashvili A, Fisher JD, DeLaney J, et al. Intravenous sedation for cardiac procedures can be administered safely and cost-effectively by non-anesthesia personnel. J Interv Card Electrophysiol. 2008;21(1):43-51. 
2. Steward DJ. A simplified scoring system for the post-operative recovery room. Can Anaesth Soc J. 1975;22(1):111-113. 
3. Sayfo S, Vakil KP, Alqaqa'a A, et al. A retrospective analysis of proceduralist-directed, nurse-administered propofol sedation for implantable cardioverter-defibrillator procedures. Heart Rhythm. 2012;9(3):342-346. 
4. Stojeba N, Steib A, Fournier S, Loewenthal A, Chauvin M. Anesthesia and implantable automatic defibrillator. Ann Fr Anesth Reanim. 1996;15(3):295-303. 
5. Moerman A, Herregods L, Tavernier R, Jordaens L, Struys M, Rolly G. Influence of anaesthesia on defibrillation threshold. Anaesthesia. 1998;53(12):1156-1159. 
6. Pacifico A, Wheelan KR, Nasir N,Jr, et al. Long-term follow-up of cardioverter-defibrillator implanted under conscious sedation in prepectoral subfascial position. Circulation. 1997;95(4):946-950. 
7. Tung RT, Bajaj AK. Safety of implantation of a cardioverter-defibrillator without general anesthesia in an electrophysiology laboratory. Am J Cardiol. 1995;75(14):908-912. 
8. Manolis AS, Maounis T, Vassilikos V, Chiladakis J, Cokkinos DV. Electrophysiologist-implanted transvenous cardioverter defibrillators using local versus general anesthesia. Pacing Clin Electrophysiol. 2000;23(1):96-105. 
9. Natale A, Kearney MM, Brandon MJ, et al. Safety of nurse-administered deep sedation for defibrillator implantation in the electrophysiology laboratory. J Cardiovasc Electrophysiol. 1996;7(4):301-306. 
10. Geiger MJ, Wase A, Kearney MM, et al. Evaluation of the safety and efficacy of deep sedation for electrophysiology procedures administered in the absence of an anesthetist. Pacing Clin Electrophysiol. 1997;20(7):1808-1814. 
11. Gaitan BD, Trentman TL, Fassett SL, Mueller JT, Altemose GT. Sedation and analgesia in the cardiac electrophysiology laboratory: A national survey of electrophysiologists investigating the who, how, and why? .Q��������3	@	B	E	_
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12. Conway A, Page K, et al. Nurse-administered procedural sedation and analgesia in the cardiac catheter laboratory: an integrative review. Int J Nurs Stud 2011;48 (8): 1012-23
























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