- Email: [email protected]
Same-Day Discharge After Treatment with the Pipeline Embolization Device Using Monitored Anesthesia Care
Original Article
Same-Day Discharge After Treatment with the Pipeline Embolization Device Using Monitored Anesthesia Care Mario Zanaty1, Badih Daou4, Nohra Chalouhi4, Robert M. Starke5, Edgar Samaniego2, Colin Derdeyn3, Pascal Jabbour4, David Hasan1
OBJECTIVE: The Pipeline Embolization Device (PED) has been used and shown to be safe under monitored anesthesia care (MAC). We present the results of the first study, to our knowledge, assessing the safety and feasibility of same-day discharge in patients undergoing treatment with the PED, using MAC.
-
METHODS: A total of 130 patients with 143 cerebral aneurysms (CAs) were identified. Patients were treated under MAC with the PED. All of the patients were counseled preoperatively about the elective nature of the procedure and the same-day discharge.
-
RESULTS: The mean age of the participants was 60.7 12.12 years. Men constituted 27.69% (36/130) of the population. The number of procedures was 138. All of our patients elected to return home the same day, whereas only 6.15% (8/130) of them changed their mind in the postoperative setting and elected to stay overnight out of convenience (late discharge, patient preference, or living alone at home). Overall discharge home on the same day occurred after 90.6% of procedures (125/138) and in 91.53% (119/130) of the patients. All same-day discharges took place within 4e6 hours after the procedures. The rate of major complications was 0.75% (1/134). The mortality rate was 0%.
-
CONCLUSIONS: PED treatment under MAC is feasible and safe. This has brought forth an era of outpatient
-
Key words - Aneurysm - Coiling - Flow diversion - Interventional - Outcome - Pipeline - Same-day discharge - Stenting Abbreviations and Acronyms CA: Cerebral aneurysm CI: Confidence interval GA: General anesthesia MAC: Monitored anesthesia care PED: Pipeline Embolization Device
WORLD NEUROSURGERY 96: 31-35, DECEMBER 2016
treatment of CAs where patients are discharged home 6 hours after the procedure.
INTRODUCTION
F
low diverters have recently emerged as a promising treatment modality for cerebral aneurysms (CAs). The Pipeline Embolization Device (PED [EV3, Irvine, California, USA]) is the most widely used flow diverter. The device is being used to treat not only complex, wide-necked, and giant aneurysms, but also simple and small aneurysms that are also amenable to conventional endovascular coiling.1,2 Several studies have shown that the PED provides durable aneurysm closure in up to 90% of patients with low rates of hemorrhagic and thromboembolic complications.3-5 In previous studies, patients were observed for 24 hours or longer after embolization. Some patients are even monitored overnight in the intensive care unit. This regimen may increase cost without benefit in patients without procedural complications.6 We present the results of the first study, to our knowledge, assessing the safety and feasibility of same-day discharge in patients undergoing treatment with the PED. METHODS Patient Cohort After obtaining the institutional review board approval from our institution, we searched our prospectively maintained database for
From the Departments of 1Neurosurgery, 2Neurology and Interventional Radiology, and 3 Radiology and Interventional Radiology, University of Iowa Hospital and Clinics, Iowa City, Iowa; 4Department of Neurological Surgery, Thomas Jefferson University and Jefferson Hospital for Neuroscience, Philadelphia, Pennsylvania; and 5Department of Neurosurgery, University of Virginia, Charlottesville, Virginia, USA To whom correspondence should be addressed: David Hasan, M.D. [E-mail: [email protected]] Citation: World Neurosurg. (2016) 96:31-35. http://dx.doi.org/10.1016/j.wneu.2016.08.050 Journal homepage: www.WORLDNEUROSURGERY.org Available online: www.sciencedirect.com 1878-8750/$ - see front matter ª 2016 Elsevier Inc. All rights reserved.
www.WORLDNEUROSURGERY.org
31
ORIGINAL ARTICLE MARIO ZANATY ET AL.
SAME-DAY DISCHARGE AFTER PIPELINE EMBOLIZATION
all patients who underwent elective PED embolization between January and November 2015. A total of 130 patients were identified. Medical charts, angiographic studies, magnetic resonance imaging, and computed tomography scans were carefully reviewed. Patient’s age and sex and aneurysm’s size and location were recorded. Treatment was dictated by the dual-trained attending neurosurgeon. The procedure was performed under monitored anesthesia care (MAC). None of the patients required general anesthesia (GA). All of the patients were counseled preoperatively about the elective nature of the procedure and the same-day discharge. Patients were discharged 6 hours after the procedure, unless they elected to stay or a complication had occurred. Thromboembolic and ischemic complications were diagnosed clinically (new deficits or change in level of consciousness) and by computed tomography scans or magnetic resonance imaging (new infarcts).
Patient Outcome The primary clinical outcome was whether the patient was discharged or not from the hospital the same day after the procedure. Complications are reported perioperatively and through follow-up. Angiographic follow-up (digital subtraction angiogram or magnetic resonance angiography) was scheduled at 6 months. Data are presented as mean and range for continuous variables and as frequency for categorical variables.
Procedure The procedure is performed in a hybrid room under monitored anesthesia. Patients are typically placed on aspirin 325 mg and clopidogrel 75 mg for 1 week prior to the procedure. Alternatively, they are loaded with 600 mg of clopidogrel and aspirin 325 mg the day of surgery. The procedure is typically performed with a 6F sheath. After the procedure, they are observed for 2 hours in the postanesthesia care unit and for 4 hours in second-stage recovery. Before their final discharge, a neurologic examination and arterial puncture site check are performed. They are instructed to call back if they develop any of the warning signs. Patients who live far away from the hospital are encouraged to stay overnight.
RESULTS Patient Characteristics We identified 130 patients with 143 CAs who were scheduled to undergo elective treatment with the PED under MAC. A total of 138 procedures were performed. The mean age of the participants was 60.7 12.12 years. Men constituted 27.69% (36/130) of the population. All of the 130 patients elected preoperatively to return home the same day. Postoperatively, only 6.15% (8/130) elected to stay overnight out of convenience (late discharge, patient preference, or living alone). One patient (0.77%) was watched overnight because of intraoperative bradycardia. The remaining 129 patients (99.23%) were discharged within 4e6 hours after the procedure. Overall discharge home on the same day occurred after 90.6% (125/138) of the procedures.
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Treatment-Related Complications The rate of periprocedural intracranial complications was 0.75% (1/134). This one case was a patient who underwent treatment of a left P1 aneurysm and was discharged home on the same day. The patient was not compliant with clopidogrel and aspirin prior to the procedure and after it. The patient subsequently developed rightsided weakness and right hemianopia from in-stent thrombosis and resultant posterior cerebral artery infarct. An emergent mechanical thrombectomy on postoperative day 1 was performed and resulted in complete neurologic recovery. The modified Rankin scale score at time of discharge was 1. Since then, we developed a preoperative checklist that includes questions regarding antiplatelet use prior to the operation. Patients who forgot or did not to take their medication will undergo loading with clopidogrel and aspirin (as previously discussed). There were no other thromboembolic complications. There were no aneurysm ruptures, parenchymal hemorrhages, or vessel perforation in the perioperative period. There was a rate of 3.73% (5/134) of groin hematoma. There were no procedural-related deaths. We present 1 illustrative case (Figure 1). Other complications are included in Table 1. DISCUSSION The treatment of CAs has evolved dramatically with the introduction of endovascular therapy and furthermore with the introduction of flow-diversion devices. This has allowed for the effective and minimally invasive treatment of complex aneurysms. The PED is being used to treat both simple and complex aneurysms, with high rates of complete occlusions and a low complication rate.7 The PED is designed as a stand-alone device, but it can also be used in conjunction with coiling, especially in the acute phase of subarachnoid hemorrhage where immediate closure of the aneurysm is required.8 Saatci et al.9 treated 251 aneurysms in 191 patients, with a morbidity rate of 1% and a mortality rate of 0.5%. Brinjikji et al.,10 in their meta-analysis of 29 studies that included 1452 patients with 1654 CAs, found the procedure-related morbidity and mortality of the PED to be 5% (95% confidence interval [CI], 4%e7%) and 4% (95% CI, 3%e6%), respectively, and the complete occlusion rate to be 76% (95% CI, 70%e81%). For its ease of use and multiple indications, flow diversion is rapidly gaining grounds and is now being considered by many practitioners as the first-line endovascular treatment for complex aneurysms. Traditionally, GA is preferred for endovascular interventions for concerns of safety (intraoperative rupture), patient comfort, better quality imaging, and hemodynamic concerns,11 despite the absence of head-to-head comparison. On the other hand, MAC would allow detection of intraoperative complications that would have remained undetected until extubation, by monitoring for neurologic changes.12 This would possibly alter the course of the procedure and improve outcome.12 Other benefits of MAC include shorter time and lower costs.13 However, MAC can be converted to GA when intraoperative complications occur or for need of better image visualization. Recently, Rangel-Castilla et al.12 treated 130 patients harboring 139 aneurysms under conscious sedation, 8 of which were in the acute phase, with a mean procedure length of 1 hour and 25 minutes and a mean fluoroscopy time of
WORLD NEUROSURGERY, http://dx.doi.org/10.1016/j.wneu.2016.08.050
ORIGINAL ARTICLE MARIO ZANATY ET AL.
SAME-DAY DISCHARGE AFTER PIPELINE EMBOLIZATION
Figure 1. (A) Intraoperative angiogram showing a basilar artery aneurysm in an elderly patient.
36.17 minutes. Periprocedural complications and long-term complications were 7.1% and 3.2% respectively, according to the authors, none of which could have been avoided by the use of GA.12 PED embolization has been already shown to have shorter procedural time and less radiation exposure when compared with traditional coiling techniques.14,15 Using MAC would further shorten the exposure to radiation and the procedural time in PED procedures.12 When given the choice in the preoperative setting, all of our patients elected to return home the same day, whereas only 4 of 61 patients stayed overnight for postoperative observation. Most patients preferred same-day discharge when undergoing treatment of CAs. Furthermore, same-day discharge within 6 hours postoperatively will significantly reduce the costs of hospitalization. Another benefit is the treatment of patients with significant comorbidities where GA is contraindicated or associated with high
Table 1. Periprocedural Complications Periprocedural Complications
Rate
Acute ischemic event
0.75 (1/134)
Acute hemorrhagic event
0.00 (0/134)
Groin hematoma
3.73 (5/134)
Femoral artery aneurysm requiring injections
0.74 (1/1/34)
Values are percent (number of cases/total number of participants).
WORLD NEUROSURGERY 96: 31-35, DECEMBER 2016
(B) Pipeline Embolization Device embolization of the same aneurysm under monitored anesthetic care.
risk of mortality and morbidity. In fact, Monk et al.16 reported 1-year mortality after GA of 5.5% in all patients, which increases to 10.5% in patients over 65 years old. However, patient selection prior to discharge is key. Patient’s compliance, whether the patient is living alone or has family support, distance from home, and other logistics should also be considered at the time of discharge. In our complication, it is unclear if keeping the patient hospitalized overnight would have prevented the development of a stroke. Even more, stroke or other potential complications could happen at any point in the future and therefore should not on its own dictate the length of stay. However, instituting preoperative and postoperative checklists would improve the safety of such techniques (Tables 2 and 3). Early discharge after endovascular procedures has rarely been described in neurosurgical literature,17 and only a few studies have evaluated early discharge in cardiovascular literature.18-20 One study compared early and standard discharge for patients with thoracic endovascular aneurysm repair and reported that patients discharged home early after the endovascular intervention had significantly lower 30-day readmission rates and hospital costs, without increased 30-day postdischarge mortality.20 Another study that evaluated same-day discharge after elective percutaneous coronary intervention concluded that even though same-day discharge is rarely implemented, it is not associated with increased death or rehospitalization compared with overnight observation.19 Another trial reported that same-day discharge after percutaneous coronary intervention was associated with patient-reported and clinical outcomes similar to those of next-day discharge and was preferred by most patients.18 Similarly,
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ORIGINAL ARTICLE MARIO ZANATY ET AL.
SAME-DAY DISCHARGE AFTER PIPELINE EMBOLIZATION
Table 2. Preoperative Checklist
Table 3. Postoperative Checklist
Preoperative Checklist
Keep inpatient for overnight observation if
-
The usual OR checklist (preinduction, consent, etc.). Aspirin and clopidogrel status: was the patient on aspirin 325 mg and clopidogrel 75 mg for 1 week prior to the procedure? If not, load with 600 mg of clopidogrel and Aspirin 325 mg the day of surgery.
-
No family support or living alone
-
Patient is not independent
-
Patient lives more than 3e4 hours away (relative)
-
No discharge after 7:00
-
Patient not compliant with aspirin and clopidogrel
-
Patient opted to stay
-
Physician discretion (if high-risk surgery, or groin puncture site is oozing)
-
Any neurochange from baseline
PM
-
Contrast allergy: if positive, search for documented pretreatment (institutional protocol by the radiology department).
-
Laboratories check (creatinine).
-
Nephrotoxic medication stopped (including metformin).
-
If on warfarin, check last international normalized ratio and if warfarin was stopped 3 days prior.
-
If on heparin, check if partial thromboplastin time (PTT) goal and inform the surgeon (ideally PTT <40, 2 hours prior to the procedure).
-
Patient does not subscribe to any of the above Patient was successfully watched for a total duration of 6 hours
Low molecular weight heparin should be stopped 12 hours prior to the procedure.
-
Final neurocheck prior to discharge is baseline, and the puncture site is dry
-
Patient understands postoperative care
-
-
Neurologic examination performed?
-
Vascular examination.
OR, operating room.
same-day discharge was preferred by all patients in our study. Several institutions have moved to early discharge after elective aneurysm coiling. One study reported that next-day patient discharge after coiling was not associated with increased 30-day adverse outcome.17 In addition, studies that compared costs of coiling and clipping showed that the actual cost associated with the endovascular coiling procedure was higher because of the higher material cost of coils; however, the shorter hospitalization resulted in lower total hospital costs with coiling compared with surgery.21-23 With the increasing experience using the PED, complications are being reduced, which opens the way to earlier discharge. In our experience, shortening of hospital stay after PED therapy could result in further reduction of the total costs and was safe.
REFERENCES 1. Chitale R, Gonzalez LF, Randazzo C, Dumont AS, Tjoumakaris S, Rosenwasser R, et al. Single center experience with pipeline stent: feasibility, technique, and complications. Neurosurgery. 2012; 71:679-691 [discussion: 691]. 2. Chalouhi N, Zanaty M, Whiting A, Yang S, Tjoumakaris S, Hasan D, et al. Safety and efficacy of the Pipeline Embolization Device in 100 small intracranial aneurysms. J Neurosurg. 2015;122: 1498-1502. 3. Zanaty M, Chalouhi N, Starke RM, Barros G, Saigh MP, Schwartz EW, et al. Flow diversion versus conventional treatment for carotid cavernous aneurysms. Stroke. 2014;45:2656-2661. 4. Zanaty M, Chalouhi N, Tjoumakaris SI, Rosenwasser RH, Gonzalez LF, Jabbour P.
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Patient can be discharged if
Limitations All of the procedures were performed by a single surgeon at a single institution. Most of the data, except the primary outcome, were retrospectively collected. Nevertheless, our results support the outpatient setting for the treatment of unruptured CAs. This study does not include complications that happened after 48 hours of the procedure because the aim is not to assess the safety of the PED but the safety of outpatient treatment compared with overnight observation. CONCLUSIONS In patients undergoing PED treatment under MAC, same-day discharge is associated with a low rate of major complications and appeared to be safe. This has brought forth an era of outpatient treatment of CAs where patients are discharged home 6 hours after the procedure. Same-day discharge is cost-effective, feasible, and associated with higher patient satisfaction.
Flow-diversion panacea or poison? Front Neurol. 2014;5:21. 5. Chalouhi N, Zanaty M, Whiting A, Tjoumakaris S, Hasan D, Ajiboye N, et al. Treatment of ruptured intracranial aneurysms with the pipeline embolization device. Neurosurgery. 2015;76:165-172 [discussion: 172]. 6. Eisen SH, Hindman BJ, Bayman EO, Dexter F, Hasan DM. Elective endovascular treatment of unruptured intracranial aneurysms: a management case series of patient outcomes after institutional change to admit patients principally to postanesthesia care unit rather than to intensive care. Anesth Analg. 2015;121:188-197. 7. Chalouhi N, Tjoumakaris S, Phillips JL, Starke RM, Hasan D, Wu C, et al. A single pipeline embolization device is sufficient for treatment of intracranial aneurysms. AJNR Am J Neuroradiol. 2014;35:1562-1566.
8. Lin N, Brouillard AM, Krishna C, Mokin M, Natarajan SK, Sonig A, et al. Use of coils in conjunction with the pipeline embolization device for treatment of intracranial aneurysms. Neurosurgery. 2015;76:142-149. 9. Saatci I, Yavuz K, Ozer C, Geyik S, Cekirge HS. Treatment of intracranial aneurysms using the pipeline flow-diverter embolization device: a single-center experience with long-term follow-up results. AJNR Am J Neuroradiol. 2012;33:1436-1446. 10. Brinjikji W, Murad MH, Lanzino G, Cloft HJ, Kallmes DF. Endovascular treatment of intracranial aneurysms with flow diverters: a meta-analysis. Stroke. 2013;44:442-447. 11. Abou-Chebl A, Lin R, Hussain MS, Jovin TG, Levy EI, Liebeskind DS, et al. Conscious sedation versus general anesthesia during endovascular therapy for acute anterior circulation stroke:
WORLD NEUROSURGERY, http://dx.doi.org/10.1016/j.wneu.2016.08.050
ORIGINAL ARTICLE MARIO ZANATY ET AL.
SAME-DAY DISCHARGE AFTER PIPELINE EMBOLIZATION
preliminary results from a retrospective, multicenter study. Stroke. 2010;41:1175-1179.
16. Monk TG, Saini V, Weldon BC, Sigl JC. Anesthetic management and one-year mortality after noncardiac surgery. Anesth Analg. 2005;100:4-10.
surgeon reimbursement at the university of Florida. Neurosurgery. 2009;64:614-619 [discussion: 619-621].
12. Rangel-Castilla L, Cress MC, Munich SA, Sonig A, Krishna C, Gu EY, Snyder KV, et al. Feasibility, safety, and periprocedural complications of pipeline embolization for intracranial aneurysm treatment under conscious sedation. Neurosurgery. 2015; 11(suppl 3):426-430.
17. Zakhari N, Lum C, Quateen A, Iancu D, Lesiuk H. Next day discharge after elective intracranial aneurysm coiling: is it safe? J Neurointerv Surg. 2016; 8:983-986.
22. Bairstow P, Dodgson A, Linto J, Khangure M. Comparison of cost and outcome of endovascular and neurosurgical procedures in the treatment of ruptured intracranial aneurysms. Australas Radiol. 2002;46:249-251.
13. Brinjikji W, Murad MH, Rabinstein AA, Cloft HJ, Lanzino G, Kallmes DF. Conscious sedation versus general anesthesia during endovascular acute ischemic stroke treatment: a systematic review and meta-analysis. AJNR Am J Neuroradiol. 2015;36:525-529. 14. Chalouhi N, McMahon JF, Moukarzel LA, Starke RM, Jabbour P, Dumont AS, et al. Flow diversion versus traditional aneurysm embolization strategies: analysis of fluoroscopy and procedure times. J Neurointerv Surg. 2014;6:291-295. 15. Colby GP, Lin LM, Nundkumar N, Jiang B, Huang J, Tamargo RJ, et al. Radiation dose analysis of large and giant internal carotid artery aneurysm treatment with the pipeline embolization device versus traditional coiling techniques. J Neurointerv Surg. 2015;7:380-384.
18. Kim M, Muntner P, Sharma S, Choi JW, Stoler RC, Woodward M, et al. Assessing patient-reported outcomes and preferences for same-day discharge after percutaneous coronary intervention: results from a pilot randomized, controlled trial. Circ Cardiovasc Qual Outcomes. 2013;6:186-192. 19. Rao SV, Kaltenbach LA, Weintraub WS, Roe MT, Brindis RG, Rumsfeld JS, et al. Prevalence and outcomes of same-day discharge after elective percutaneous coronary intervention among older patients. JAMA. 2011;306:1461-1467. 20. Brooke BS, Goodney PP, Powell RJ, Fillinger MF, Travis LL, Goodman DC, et al. Early discharge does not increase readmission or mortality after high-risk vascular surgery. J Vasc Surg. 2013;57: 734-740.
23. Halkes PH, Wermer MJ, Rinkel GJ, Buskens E. Direct costs of surgical clipping and endovascular coiling of unruptured intracranial aneurysms. Cerebrovasc Dis. 2006;22:40-45.
Conflict of interest statement: The authors declare that the article content was composed in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. Received 17 June 2016; accepted 12 August 2016 Citation: World Neurosurg. (2016) 96:31-35. http://dx.doi.org/10.1016/j.wneu.2016.08.050 Journal homepage: www.WORLDNEUROSURGERY.org
21. Hoh BL, Chi YY, Dermott MA, Lipori PJ, Lewis SB. The effect of coiling versus clipping of ruptured and unruptured cerebral aneurysms on length of stay, hospital cost, hospital reimbursement, and
WORLD NEUROSURGERY 96: 31-35, DECEMBER 2016
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35
Same-Day Discharge After Treatment with the Pipeline Embolization Device Using Monitored Anesthesia Care Mario Zanaty1, Badih Daou4, Nohra Chalouhi4, Robert M. Starke5, Edgar Samaniego2, Colin Derdeyn3, Pascal Jabbour4, David Hasan1
OBJECTIVE: The Pipeline Embolization Device (PED) has been used and shown to be safe under monitored anesthesia care (MAC). We present the results of the first study, to our knowledge, assessing the safety and feasibility of same-day discharge in patients undergoing treatment with the PED, using MAC.
-
METHODS: A total of 130 patients with 143 cerebral aneurysms (CAs) were identified. Patients were treated under MAC with the PED. All of the patients were counseled preoperatively about the elective nature of the procedure and the same-day discharge.
-
RESULTS: The mean age of the participants was 60.7 12.12 years. Men constituted 27.69% (36/130) of the population. The number of procedures was 138. All of our patients elected to return home the same day, whereas only 6.15% (8/130) of them changed their mind in the postoperative setting and elected to stay overnight out of convenience (late discharge, patient preference, or living alone at home). Overall discharge home on the same day occurred after 90.6% of procedures (125/138) and in 91.53% (119/130) of the patients. All same-day discharges took place within 4e6 hours after the procedures. The rate of major complications was 0.75% (1/134). The mortality rate was 0%.
-
CONCLUSIONS: PED treatment under MAC is feasible and safe. This has brought forth an era of outpatient
-
Key words - Aneurysm - Coiling - Flow diversion - Interventional - Outcome - Pipeline - Same-day discharge - Stenting Abbreviations and Acronyms CA: Cerebral aneurysm CI: Confidence interval GA: General anesthesia MAC: Monitored anesthesia care PED: Pipeline Embolization Device
WORLD NEUROSURGERY 96: 31-35, DECEMBER 2016
treatment of CAs where patients are discharged home 6 hours after the procedure.
INTRODUCTION
F
low diverters have recently emerged as a promising treatment modality for cerebral aneurysms (CAs). The Pipeline Embolization Device (PED [EV3, Irvine, California, USA]) is the most widely used flow diverter. The device is being used to treat not only complex, wide-necked, and giant aneurysms, but also simple and small aneurysms that are also amenable to conventional endovascular coiling.1,2 Several studies have shown that the PED provides durable aneurysm closure in up to 90% of patients with low rates of hemorrhagic and thromboembolic complications.3-5 In previous studies, patients were observed for 24 hours or longer after embolization. Some patients are even monitored overnight in the intensive care unit. This regimen may increase cost without benefit in patients without procedural complications.6 We present the results of the first study, to our knowledge, assessing the safety and feasibility of same-day discharge in patients undergoing treatment with the PED. METHODS Patient Cohort After obtaining the institutional review board approval from our institution, we searched our prospectively maintained database for
From the Departments of 1Neurosurgery, 2Neurology and Interventional Radiology, and 3 Radiology and Interventional Radiology, University of Iowa Hospital and Clinics, Iowa City, Iowa; 4Department of Neurological Surgery, Thomas Jefferson University and Jefferson Hospital for Neuroscience, Philadelphia, Pennsylvania; and 5Department of Neurosurgery, University of Virginia, Charlottesville, Virginia, USA To whom correspondence should be addressed: David Hasan, M.D. [E-mail: [email protected]] Citation: World Neurosurg. (2016) 96:31-35. http://dx.doi.org/10.1016/j.wneu.2016.08.050 Journal homepage: www.WORLDNEUROSURGERY.org Available online: www.sciencedirect.com 1878-8750/$ - see front matter ª 2016 Elsevier Inc. All rights reserved.
www.WORLDNEUROSURGERY.org
31
ORIGINAL ARTICLE MARIO ZANATY ET AL.
SAME-DAY DISCHARGE AFTER PIPELINE EMBOLIZATION
all patients who underwent elective PED embolization between January and November 2015. A total of 130 patients were identified. Medical charts, angiographic studies, magnetic resonance imaging, and computed tomography scans were carefully reviewed. Patient’s age and sex and aneurysm’s size and location were recorded. Treatment was dictated by the dual-trained attending neurosurgeon. The procedure was performed under monitored anesthesia care (MAC). None of the patients required general anesthesia (GA). All of the patients were counseled preoperatively about the elective nature of the procedure and the same-day discharge. Patients were discharged 6 hours after the procedure, unless they elected to stay or a complication had occurred. Thromboembolic and ischemic complications were diagnosed clinically (new deficits or change in level of consciousness) and by computed tomography scans or magnetic resonance imaging (new infarcts).
Patient Outcome The primary clinical outcome was whether the patient was discharged or not from the hospital the same day after the procedure. Complications are reported perioperatively and through follow-up. Angiographic follow-up (digital subtraction angiogram or magnetic resonance angiography) was scheduled at 6 months. Data are presented as mean and range for continuous variables and as frequency for categorical variables.
Procedure The procedure is performed in a hybrid room under monitored anesthesia. Patients are typically placed on aspirin 325 mg and clopidogrel 75 mg for 1 week prior to the procedure. Alternatively, they are loaded with 600 mg of clopidogrel and aspirin 325 mg the day of surgery. The procedure is typically performed with a 6F sheath. After the procedure, they are observed for 2 hours in the postanesthesia care unit and for 4 hours in second-stage recovery. Before their final discharge, a neurologic examination and arterial puncture site check are performed. They are instructed to call back if they develop any of the warning signs. Patients who live far away from the hospital are encouraged to stay overnight.
RESULTS Patient Characteristics We identified 130 patients with 143 CAs who were scheduled to undergo elective treatment with the PED under MAC. A total of 138 procedures were performed. The mean age of the participants was 60.7 12.12 years. Men constituted 27.69% (36/130) of the population. All of the 130 patients elected preoperatively to return home the same day. Postoperatively, only 6.15% (8/130) elected to stay overnight out of convenience (late discharge, patient preference, or living alone). One patient (0.77%) was watched overnight because of intraoperative bradycardia. The remaining 129 patients (99.23%) were discharged within 4e6 hours after the procedure. Overall discharge home on the same day occurred after 90.6% (125/138) of the procedures.
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Treatment-Related Complications The rate of periprocedural intracranial complications was 0.75% (1/134). This one case was a patient who underwent treatment of a left P1 aneurysm and was discharged home on the same day. The patient was not compliant with clopidogrel and aspirin prior to the procedure and after it. The patient subsequently developed rightsided weakness and right hemianopia from in-stent thrombosis and resultant posterior cerebral artery infarct. An emergent mechanical thrombectomy on postoperative day 1 was performed and resulted in complete neurologic recovery. The modified Rankin scale score at time of discharge was 1. Since then, we developed a preoperative checklist that includes questions regarding antiplatelet use prior to the operation. Patients who forgot or did not to take their medication will undergo loading with clopidogrel and aspirin (as previously discussed). There were no other thromboembolic complications. There were no aneurysm ruptures, parenchymal hemorrhages, or vessel perforation in the perioperative period. There was a rate of 3.73% (5/134) of groin hematoma. There were no procedural-related deaths. We present 1 illustrative case (Figure 1). Other complications are included in Table 1. DISCUSSION The treatment of CAs has evolved dramatically with the introduction of endovascular therapy and furthermore with the introduction of flow-diversion devices. This has allowed for the effective and minimally invasive treatment of complex aneurysms. The PED is being used to treat both simple and complex aneurysms, with high rates of complete occlusions and a low complication rate.7 The PED is designed as a stand-alone device, but it can also be used in conjunction with coiling, especially in the acute phase of subarachnoid hemorrhage where immediate closure of the aneurysm is required.8 Saatci et al.9 treated 251 aneurysms in 191 patients, with a morbidity rate of 1% and a mortality rate of 0.5%. Brinjikji et al.,10 in their meta-analysis of 29 studies that included 1452 patients with 1654 CAs, found the procedure-related morbidity and mortality of the PED to be 5% (95% confidence interval [CI], 4%e7%) and 4% (95% CI, 3%e6%), respectively, and the complete occlusion rate to be 76% (95% CI, 70%e81%). For its ease of use and multiple indications, flow diversion is rapidly gaining grounds and is now being considered by many practitioners as the first-line endovascular treatment for complex aneurysms. Traditionally, GA is preferred for endovascular interventions for concerns of safety (intraoperative rupture), patient comfort, better quality imaging, and hemodynamic concerns,11 despite the absence of head-to-head comparison. On the other hand, MAC would allow detection of intraoperative complications that would have remained undetected until extubation, by monitoring for neurologic changes.12 This would possibly alter the course of the procedure and improve outcome.12 Other benefits of MAC include shorter time and lower costs.13 However, MAC can be converted to GA when intraoperative complications occur or for need of better image visualization. Recently, Rangel-Castilla et al.12 treated 130 patients harboring 139 aneurysms under conscious sedation, 8 of which were in the acute phase, with a mean procedure length of 1 hour and 25 minutes and a mean fluoroscopy time of
WORLD NEUROSURGERY, http://dx.doi.org/10.1016/j.wneu.2016.08.050
ORIGINAL ARTICLE MARIO ZANATY ET AL.
SAME-DAY DISCHARGE AFTER PIPELINE EMBOLIZATION
Figure 1. (A) Intraoperative angiogram showing a basilar artery aneurysm in an elderly patient.
36.17 minutes. Periprocedural complications and long-term complications were 7.1% and 3.2% respectively, according to the authors, none of which could have been avoided by the use of GA.12 PED embolization has been already shown to have shorter procedural time and less radiation exposure when compared with traditional coiling techniques.14,15 Using MAC would further shorten the exposure to radiation and the procedural time in PED procedures.12 When given the choice in the preoperative setting, all of our patients elected to return home the same day, whereas only 4 of 61 patients stayed overnight for postoperative observation. Most patients preferred same-day discharge when undergoing treatment of CAs. Furthermore, same-day discharge within 6 hours postoperatively will significantly reduce the costs of hospitalization. Another benefit is the treatment of patients with significant comorbidities where GA is contraindicated or associated with high
Table 1. Periprocedural Complications Periprocedural Complications
Rate
Acute ischemic event
0.75 (1/134)
Acute hemorrhagic event
0.00 (0/134)
Groin hematoma
3.73 (5/134)
Femoral artery aneurysm requiring injections
0.74 (1/1/34)
Values are percent (number of cases/total number of participants).
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(B) Pipeline Embolization Device embolization of the same aneurysm under monitored anesthetic care.
risk of mortality and morbidity. In fact, Monk et al.16 reported 1-year mortality after GA of 5.5% in all patients, which increases to 10.5% in patients over 65 years old. However, patient selection prior to discharge is key. Patient’s compliance, whether the patient is living alone or has family support, distance from home, and other logistics should also be considered at the time of discharge. In our complication, it is unclear if keeping the patient hospitalized overnight would have prevented the development of a stroke. Even more, stroke or other potential complications could happen at any point in the future and therefore should not on its own dictate the length of stay. However, instituting preoperative and postoperative checklists would improve the safety of such techniques (Tables 2 and 3). Early discharge after endovascular procedures has rarely been described in neurosurgical literature,17 and only a few studies have evaluated early discharge in cardiovascular literature.18-20 One study compared early and standard discharge for patients with thoracic endovascular aneurysm repair and reported that patients discharged home early after the endovascular intervention had significantly lower 30-day readmission rates and hospital costs, without increased 30-day postdischarge mortality.20 Another study that evaluated same-day discharge after elective percutaneous coronary intervention concluded that even though same-day discharge is rarely implemented, it is not associated with increased death or rehospitalization compared with overnight observation.19 Another trial reported that same-day discharge after percutaneous coronary intervention was associated with patient-reported and clinical outcomes similar to those of next-day discharge and was preferred by most patients.18 Similarly,
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ORIGINAL ARTICLE MARIO ZANATY ET AL.
SAME-DAY DISCHARGE AFTER PIPELINE EMBOLIZATION
Table 2. Preoperative Checklist
Table 3. Postoperative Checklist
Preoperative Checklist
Keep inpatient for overnight observation if
-
The usual OR checklist (preinduction, consent, etc.). Aspirin and clopidogrel status: was the patient on aspirin 325 mg and clopidogrel 75 mg for 1 week prior to the procedure? If not, load with 600 mg of clopidogrel and Aspirin 325 mg the day of surgery.
-
No family support or living alone
-
Patient is not independent
-
Patient lives more than 3e4 hours away (relative)
-
No discharge after 7:00
-
Patient not compliant with aspirin and clopidogrel
-
Patient opted to stay
-
Physician discretion (if high-risk surgery, or groin puncture site is oozing)
-
Any neurochange from baseline
PM
-
Contrast allergy: if positive, search for documented pretreatment (institutional protocol by the radiology department).
-
Laboratories check (creatinine).
-
Nephrotoxic medication stopped (including metformin).
-
If on warfarin, check last international normalized ratio and if warfarin was stopped 3 days prior.
-
If on heparin, check if partial thromboplastin time (PTT) goal and inform the surgeon (ideally PTT <40, 2 hours prior to the procedure).
-
Patient does not subscribe to any of the above Patient was successfully watched for a total duration of 6 hours
Low molecular weight heparin should be stopped 12 hours prior to the procedure.
-
Final neurocheck prior to discharge is baseline, and the puncture site is dry
-
Patient understands postoperative care
-
-
Neurologic examination performed?
-
Vascular examination.
OR, operating room.
same-day discharge was preferred by all patients in our study. Several institutions have moved to early discharge after elective aneurysm coiling. One study reported that next-day patient discharge after coiling was not associated with increased 30-day adverse outcome.17 In addition, studies that compared costs of coiling and clipping showed that the actual cost associated with the endovascular coiling procedure was higher because of the higher material cost of coils; however, the shorter hospitalization resulted in lower total hospital costs with coiling compared with surgery.21-23 With the increasing experience using the PED, complications are being reduced, which opens the way to earlier discharge. In our experience, shortening of hospital stay after PED therapy could result in further reduction of the total costs and was safe.
REFERENCES 1. Chitale R, Gonzalez LF, Randazzo C, Dumont AS, Tjoumakaris S, Rosenwasser R, et al. Single center experience with pipeline stent: feasibility, technique, and complications. Neurosurgery. 2012; 71:679-691 [discussion: 691]. 2. Chalouhi N, Zanaty M, Whiting A, Yang S, Tjoumakaris S, Hasan D, et al. Safety and efficacy of the Pipeline Embolization Device in 100 small intracranial aneurysms. J Neurosurg. 2015;122: 1498-1502. 3. Zanaty M, Chalouhi N, Starke RM, Barros G, Saigh MP, Schwartz EW, et al. Flow diversion versus conventional treatment for carotid cavernous aneurysms. Stroke. 2014;45:2656-2661. 4. Zanaty M, Chalouhi N, Tjoumakaris SI, Rosenwasser RH, Gonzalez LF, Jabbour P.
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Patient can be discharged if
Limitations All of the procedures were performed by a single surgeon at a single institution. Most of the data, except the primary outcome, were retrospectively collected. Nevertheless, our results support the outpatient setting for the treatment of unruptured CAs. This study does not include complications that happened after 48 hours of the procedure because the aim is not to assess the safety of the PED but the safety of outpatient treatment compared with overnight observation. CONCLUSIONS In patients undergoing PED treatment under MAC, same-day discharge is associated with a low rate of major complications and appeared to be safe. This has brought forth an era of outpatient treatment of CAs where patients are discharged home 6 hours after the procedure. Same-day discharge is cost-effective, feasible, and associated with higher patient satisfaction.
Flow-diversion panacea or poison? Front Neurol. 2014;5:21. 5. Chalouhi N, Zanaty M, Whiting A, Tjoumakaris S, Hasan D, Ajiboye N, et al. Treatment of ruptured intracranial aneurysms with the pipeline embolization device. Neurosurgery. 2015;76:165-172 [discussion: 172]. 6. Eisen SH, Hindman BJ, Bayman EO, Dexter F, Hasan DM. Elective endovascular treatment of unruptured intracranial aneurysms: a management case series of patient outcomes after institutional change to admit patients principally to postanesthesia care unit rather than to intensive care. Anesth Analg. 2015;121:188-197. 7. Chalouhi N, Tjoumakaris S, Phillips JL, Starke RM, Hasan D, Wu C, et al. A single pipeline embolization device is sufficient for treatment of intracranial aneurysms. AJNR Am J Neuroradiol. 2014;35:1562-1566.
8. Lin N, Brouillard AM, Krishna C, Mokin M, Natarajan SK, Sonig A, et al. Use of coils in conjunction with the pipeline embolization device for treatment of intracranial aneurysms. Neurosurgery. 2015;76:142-149. 9. Saatci I, Yavuz K, Ozer C, Geyik S, Cekirge HS. Treatment of intracranial aneurysms using the pipeline flow-diverter embolization device: a single-center experience with long-term follow-up results. AJNR Am J Neuroradiol. 2012;33:1436-1446. 10. Brinjikji W, Murad MH, Lanzino G, Cloft HJ, Kallmes DF. Endovascular treatment of intracranial aneurysms with flow diverters: a meta-analysis. Stroke. 2013;44:442-447. 11. Abou-Chebl A, Lin R, Hussain MS, Jovin TG, Levy EI, Liebeskind DS, et al. Conscious sedation versus general anesthesia during endovascular therapy for acute anterior circulation stroke:
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ORIGINAL ARTICLE MARIO ZANATY ET AL.
SAME-DAY DISCHARGE AFTER PIPELINE EMBOLIZATION
preliminary results from a retrospective, multicenter study. Stroke. 2010;41:1175-1179.
16. Monk TG, Saini V, Weldon BC, Sigl JC. Anesthetic management and one-year mortality after noncardiac surgery. Anesth Analg. 2005;100:4-10.
surgeon reimbursement at the university of Florida. Neurosurgery. 2009;64:614-619 [discussion: 619-621].
12. Rangel-Castilla L, Cress MC, Munich SA, Sonig A, Krishna C, Gu EY, Snyder KV, et al. Feasibility, safety, and periprocedural complications of pipeline embolization for intracranial aneurysm treatment under conscious sedation. Neurosurgery. 2015; 11(suppl 3):426-430.
17. Zakhari N, Lum C, Quateen A, Iancu D, Lesiuk H. Next day discharge after elective intracranial aneurysm coiling: is it safe? J Neurointerv Surg. 2016; 8:983-986.
22. Bairstow P, Dodgson A, Linto J, Khangure M. Comparison of cost and outcome of endovascular and neurosurgical procedures in the treatment of ruptured intracranial aneurysms. Australas Radiol. 2002;46:249-251.
13. Brinjikji W, Murad MH, Rabinstein AA, Cloft HJ, Lanzino G, Kallmes DF. Conscious sedation versus general anesthesia during endovascular acute ischemic stroke treatment: a systematic review and meta-analysis. AJNR Am J Neuroradiol. 2015;36:525-529. 14. Chalouhi N, McMahon JF, Moukarzel LA, Starke RM, Jabbour P, Dumont AS, et al. Flow diversion versus traditional aneurysm embolization strategies: analysis of fluoroscopy and procedure times. J Neurointerv Surg. 2014;6:291-295. 15. Colby GP, Lin LM, Nundkumar N, Jiang B, Huang J, Tamargo RJ, et al. Radiation dose analysis of large and giant internal carotid artery aneurysm treatment with the pipeline embolization device versus traditional coiling techniques. J Neurointerv Surg. 2015;7:380-384.
18. Kim M, Muntner P, Sharma S, Choi JW, Stoler RC, Woodward M, et al. Assessing patient-reported outcomes and preferences for same-day discharge after percutaneous coronary intervention: results from a pilot randomized, controlled trial. Circ Cardiovasc Qual Outcomes. 2013;6:186-192. 19. Rao SV, Kaltenbach LA, Weintraub WS, Roe MT, Brindis RG, Rumsfeld JS, et al. Prevalence and outcomes of same-day discharge after elective percutaneous coronary intervention among older patients. JAMA. 2011;306:1461-1467. 20. Brooke BS, Goodney PP, Powell RJ, Fillinger MF, Travis LL, Goodman DC, et al. Early discharge does not increase readmission or mortality after high-risk vascular surgery. J Vasc Surg. 2013;57: 734-740.
23. Halkes PH, Wermer MJ, Rinkel GJ, Buskens E. Direct costs of surgical clipping and endovascular coiling of unruptured intracranial aneurysms. Cerebrovasc Dis. 2006;22:40-45.
Conflict of interest statement: The authors declare that the article content was composed in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. Received 17 June 2016; accepted 12 August 2016 Citation: World Neurosurg. (2016) 96:31-35. http://dx.doi.org/10.1016/j.wneu.2016.08.050 Journal homepage: www.WORLDNEUROSURGERY.org
21. Hoh BL, Chi YY, Dermott MA, Lipori PJ, Lewis SB. The effect of coiling versus clipping of ruptured and unruptured cerebral aneurysms on length of stay, hospital cost, hospital reimbursement, and
WORLD NEUROSURGERY 96: 31-35, DECEMBER 2016
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