There are numerous challenges today in the delivery of healthcare. Perceptions of performance and quality of healthcare organizations have begun to move beyond examining the provision of excellent clinical care alone, and instead consider and embrace the patient experience as an important indicator.1 One area that has reached the forefront is patient satisfaction.
Cardioversion is a commonly used method of terminating cardiac atrial arrhythmias that requires sedation.2 Failure to recognize inadequate sedation and/or signs of awareness during the procedure could correlate to decreased patient satisfaction as well as increased claims and litigation. Such claims are frequently successful.3 Elective direct current cardioversion (DCCV) is a brief but painful procedure. There is a wide variation regarding the medication strategy to facilitate this procedure.2 Our institution has several sedation protocols for cardioversion, and at times it is combined with transesophageal echo (TEE) to rule out prior thrombus in the left atrial appendage. The best sedative agent should have fast induction and recovery times.4 Ideally, patients should have no recall of procedural sedation.5 Use of etomidate has been shown to be effective in short procedural sedation because of its minimal respiratory side effects and favorable hemodynamic profile.6
We aimed to assess whether etomidate alone was sufficient, or if the addition of a benzodiazepine (midazolam) and/or narcotic (fentanyl) improved the patient experience. We also investigated whether there was a decrease in the recall or side effects from the procedure or medications. The overall goal was not only to provide excellent patient care, but also to improve overall patient experience.
This qualitative research project sought to understand and interpret the “personal experience”7 as it relates to current health care delivery at our institution. Our team wanted to research our institution’s current practice of sedation for DCCV in an effort to optimize the experience. DCCV procedures have been labeled as painful, frightening, and distressing to patients, for which some institutions will require the procedure to be carried out under general anesthesia, necessitating an anesthesiologist to be present.8 Frequently, it may be difficult to coordinate the availability of the two teams, causing delays to the patient, waste of staff time, and inefficient service and increased costs.8 Ultimately, the most ideal form of deep sedation would have fast action of onset, short recovery time, minimal CV and respiratory side effects, and enough amnesic effect to prevent recall of the event and not require the burden of general anesthesia.9
The objective of this study was to determine: (1) if patients undergoing elective DCCV have different experiences or perceptions related to different sedation practices, (2) if patients undergoing a combined DCCV and TEE procedure have better patient satisfaction outcomes, and (3) the best practice protocol for sedation of patients undergoing DCCV, or whether further research is needed.
About the Study
An IRB-approved study at the Penn State Health Milton S. Hershey Medical Center was undertaken in 2014, and a prospective patient experience evaluation was offered to 152 consecutive patients referred for DCCV between January 2014 and January 2015. Of those responding, the sedation protocol was reviewed retrospectively. The protocols were categorized as etomidate, midazolam/etomidate, and fentanyl/midazolam/etomidate. All patients were given etomidate. Midazolam was used per provider preference or as an adjunct to assess left atrial appendage via TEE to rule out clot prior to cardioversion. Fentanyl was given to all patients receiving a transesophageal echocardiogram.
Primary outcomes included subjective assessment of peri-procedural symptoms (nausea, dizziness, headache, chills, skin irritation, burning, and redness at the site of the pad placement) and recall of the experience. Patients were also asked how soon after the procedure they were able to resume normal activities. They were asked to recall any of their experience, from sedation to cardioversion, and if there was anything they would change (Table 1). The questionnaire was designed to address patient perception of a single condition, and was sensitive to clinically important changes.10
Questions were categorized as yes or no, and assessed by Fisher’s exact testing. Non-normally distributed values were given in median (95% confidence interval). Odds ratios, sensitivities, specificities, and positive and negative predictive values were assessed. Qualitative and subjective descriptions provided by patients were evaluated and correlated to a positive or negative experience.
Fifty-three patients completed questionnaires (62.9% male). The median etomidate dose was 6 mg (95% CI, 5 mg to 8 mg). The addition of midazolam (to etomidate) was used in 26 (49.1%) of patients, with a median dose of 2 mg (95% CI, 2 to 4 mg) without significantly lower etomidate dose (P value=0.78). Four patients required transesophageal echocardiogram and fentanyl.
Seven patients reported peri-procedural symptoms (13.2%): 3 experienced headaches, 2 experienced dizziness, 2 experienced chills, and 1 experienced nausea (Table 3). All 7 patients had received a midazolam dose of 0.0224 mg/kg or higher, with a sensitivity of 100%, specificity of 55%, positive predictive value of 25%, and negative predictive value of 100% (odds ratio 17.8). There was no significant association to dose of etomidate or fentanyl. (Table 2)
Two patients reported recall of the experience. Both were in the midazolam/etomidate group and had received a dose of at least 3 mg of midazolam (at least 0.033 mg/kg), with a sensitivity of 100%, specificity of 73%, positive predictive value of 25%, and negative predictive value of 100%.
The study compared and contrasted the three different types of sedation protocols currently used in our electrophysiology laboratory when performing DCCV. This study was designed to correlate patients’ post-procedure perceptions of procedural recall to the different types of sedation administration. This was accomplished by completion and return of our 10-item questionnaire.
The results yielded a favorable usefulness for etomidate as a standalone agent. Etomidate is an imidazole that is used for induction of general anesthesia. It is effective as a hypnotic, and is associated with having minimal hemodynamic change as well as a favorable therapeutic index for single-bolus administration; potential side effects include myoclonus or significant pain on injection. In this study, we learned that the use of several conscious sedation protocols for DCCV were perceived differently, but the patients that received etomidate alone reported no procedure recall and no complaints of myoclonus or IV site burning, unlike patients who received a midazolam/etomidate or fentanyl/midazolam/etomidate combination. Sedative drugs added to etomidate did not correlate with improved perception of the procedure, but instead had unwanted side effects or procedure recall.
Limitations of the study included a relatively small sample size and qualitative research that was non-randomized. The patient return rate of the study questionnaire was variable and dependent on the voluntary acceptance of the patient. Multiple cardioversions on the same patient, at different times, meant that those patients had to fill out a subsequent questionnaire.
Although all modalities of sedation resulted in favorable patient experience, etomidate alone for DCCV was associated with no peri-procedural symptoms and patient recall, when compared to the combination of midazolam/etomidate or fentanyl/midazolam/etomidate. In our small cohort of patients, etomidate alone for procedural sedation resulted in favorable patient satisfaction for an otherwise uncomfortable procedure.
Disclosures: The authors have no conflicts of interest to report regarding the content herein.
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