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Carotid Endarterectomy and Carotid Artery Stenting for Symptomatic Carotid Stenosis: An Experience of a Hybrid Neurosurgeon in a Developing Nation
Correspondence Address: Source of Support: None, Conflict of Interest: None DOI: 10.4103/0028-3886.336326
Material and Methods: From Jan 2014–Dec 2017, 80 patients presented with symptomatic carotid stenosis. Out of these 80 patients, 65 underwent intervention; 34 patients underwent CEA and 31 patients underwent CAS. Pre-defined variables like age, sex, and degree of stenosis were assessed as potential risk factors, and the patients' clinical features, radiological imaging, and procedural complications were documented. Results: The primary outcome of procedure-related stroke, major adverse events (MAEs), and death at 30 days follow-up and long-term outcomes of restenosis at 1 year were analyzed. Peri-procedural stroke occurred in 2 cases (6.4%) of CAS; one suffered an ischemic stroke and other suffered a hemorrhagic stroke. Three cases of CEA suffered procedure-related events; one (2.9%) suffered TIA while the other two developed postoperative local hematoma without neurological deficit; one was treated conservatively while the other required re-exploration due to pressure symptoms. Restenosis occurred in one case that underwent CAS. Conclusion: CAS and CEA are complementary approaches in treating symptomatic carotid stenosis even when performed by a single hybrid neurosurgeon as results obtained are commensurable to major studies like CREST. Keywords: Carotid artery stenting, carotid endarterectomy, CAS, CEA, dual-trained neurosurgeon, hybrid neurosurgeon, symptomatic carotid stenosis
Internal carotid artery (ICA) atherosclerosis is a major risk factor for stroke,[1] especially in patients with amaurosis fugax or transient ischemic attack (TIA), and leads to approximately 30% of all ischemic strokes.[2] 2%–6% annual risk of stroke is observed in patients with asymptomatic stenosis of >50%[3] while symptomatic carotid stenosis accounts for an even higher annual risk of stroke. Treatment modalities include medical management (treatment of vascular risk factors), carotid endarterectomy (CEA), and carotid artery stenting (CAS), which have shown to decrease the risk of subsequent stroke and reduces stroke-related morbidity and mortality. The advent of statins and multiple antiplatelet drugs revolutionized the medical management of carotid stenosis. However, carotid endarterectomy has prevailed as ”gold standard” treatment for patients with symptomatic and asymptomatic carotid artery stenosis proven by multicentric trials like The North American Symptomatic Carotid Endarterectomy Trial (NASCET),[4],[5],[6] European Carotid Surgery Trial (ECST),[7] and Asymptomatic Carotid Surgery Trial (ACST).[8],[9] In the 1990s, endovascular treatments (first balloon angioplasty and then stenting) emerged as a safer and less invasive alternative to endarterectomy, especially in high-risk cases. However, trials such as Stent-Protected Angioplasty versus Carotid Endarterectomy (SPACE),[10] Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy (SAPPHIRE),[11],[12] and Carotid Revascularization Endarterectomy versus Stenting Trial (CREST)[13],[14] have failed to demonstrate significant short or long term differences between the 2 cohorts receiving CEA or CAS with distal protection with respect to the combined primary endpoint of stroke, death, and myocardial infarction (MI). Because most of these trials were performed in academic centers, a vigorous training course was required for the surgeons and interventionists selected to enroll in these trials.[15] This has raised a concern regarding the generalization of these results and has made it necessary to determine whether similar results can be obtained in community settings by a single hybrid neurosurgeon. This study puts forward a single “dual-trained” neurosurgeon's experience with CAS and CEA performed in symptomatic carotid artery stenosis and compares the result of this study with the multicenter trials such as CREST, SPACE, etc., so as to prove the generalizability of these trials in a community setting.
During a 4-year period, i.e., from January 2014-December 2017, 80 patients presented with symptomatic carotid stenosis. Out of these 80 patients, 65 patients who fulfilled the inclusion criteria were identified from operation registers and medical records and were included in this analysis, which was approved by our institutional review board and was compliant with the ethical norms. Among these 65 patients, 34 patients underwent CEA and 31 patients underwent carotid stenting operated upon by a single neurosurgeon. Patients underwent CAS if they were at high surgical risk or conditions favorable for CAS. The high surgical risk observed in our study was defined based on anatomic criteria (stenosis extending cavernous carotid, high bifurcation, previous ipsilateral neck surgery or radiation, and contralateral laryngeal nerve paralysis) and physiological criteria (Age ≥75 years, decompensated liver disease, compromised cardiopulmonary reserve and valvular heart disease, NYHA CHF Class III/IV, left ventricular ejection fraction <30%, coronary artery disease involving ≥2 vessels, unstable angina, recent MI (within 6 weeks), and chronic renal insufficiency). Inclusion criteria
Exclusion criteria
All the patients underwent a screening Duplex scan of extracranial neck vessels to assess the carotid bifurcation stenosis, followed by confirmatory imaging—a carotid angiogram or a noninvasive magnetic resonance imaging (MRI). All the cases underwent digital subtraction angiography (DSA) to estimate the grade of stenosis and to rule out any intracranial vessel cut-off or abnormality. In patients undergoing CEA, clopidogrel was withheld preoperatively while aspirin (150 mg) was continued. In patients undergoing CAS, pre-procedural doses of aspirin (150 mg) and clopidogrel (75 mg) were continued. Follow-up clinical assessment was done on a monthly basis for the first 3 months and thereafter patients were followed up quarterly till 1 year. Duplex scan was employed for check imaging to assess residual stenosis or post procedural restenosis. We assessed these patients for procedure-related morbidity and mortality, ipsilateral cerebral events, and long-term patency of the ICA. Surgical protocol [Figure 1]
For all the patients who underwent CEA, procedures were performed under general anesthesia with endotracheal intubation. [Figure 1] describes the procedure followed during carotid endarterectomy by the lead surgeon. Arteriotomy site was covered with Nu Knit surgicel. A closed drainage system was instituted for 24 h. Stenting protocol [Figure 2]
For all patients undergoing CAS, the procedure was performed under local anesthesia. [Figure 2] describes the procedure followed during carotid artery stenting by the lead surgeon. Post-procedure, all patients were shifted to ICU for neurological monitoring. Oral sips started by evening and mobilized the next day. On discharge, 150 mg aspirin and Statin (Rosuvastatin 10mg/day or Atorvastatin 20-40mg/day) started in those undergoing CEA and Aspirin 150 mg, clopidogrel 75 mg, and statins in patients undergoing CAS.
A total of 65 patients, included in the study, underwent definitive treatment for symptomatic carotid stenosis. The data was computed and analyzed. Statistical comparisons were performed using the Z-test. Of all these 65 patients included in the study, 31 patients (47.7%) underwent carotid artery stenting while the remaining 34 (52.3%) underwent carotid endarterectomy and 50 were male (76.9%) while 15 were females (23.07%). Mean age in the CEA group was lower compared with the CAS group: 58.5 years (median age: 57 years; age range 37–74 years) v/s 66.29 years (median age: 66 years; age range 55–80 years) [Table 1]. In both groups, the side of the lesion (49.23% right vs 50.76% left) was similar.
Risk factors for carotid stenosis included hypertension, smoking, elevated cholesterol level, diabetes, etc. Of all the 65 patients, hypertension and diabetes were seen to be present in the majority of the patients, one female had a history of malignancy, and one had a history of neck irradiation. More than two risk factors were observed in >45% (30/65) of patients [Table 1]. [Figure 3] denotes the grade of stenosis and the corresponding procedure done in all patients who met the inclusion criteria.
The primary outcome of stroke, other major adverse events (MAEs), and death at 30-day follow-up are given in [Table 2]. The outcome in both the groups was found not to be statistically significant (P = 0.9077) at 30-day follow-up. Two strokes (6.4%) occurred in the CAS group, both in patients who had distal embolic protection. One of these patients developed a right-sided neuro deficit during the procedure. The patient was treated conservatively and was discharged with an mRs of 2. However, symptoms partially resolved at 30-day follow-up.
In the other patient, left-sided hemiplegia with altered sensorium was detected on postoperative day 1. An NCCT brain revealed right-sided intracranial hematoma. Patient underwent a decompressive hemicraniectomy. However, the patient succumbed to multi-organ dysfunction syndrome. Thus, the primary outcome of perioperative stroke rate in CAS cohort is 6.4% and perioperative death rate secondary to perioperative stroke was 3.2%. A single case of TIA (2.9%) occurred in the CEA group. This patient was noted to have a mild deviation of face and slurring of speech on postoperative day 1 which recovered with conservative management within 24 h. Two patients in the CEA group experienced operative site hematoma formation (5.8%) of which one of these patients was re-explored due to pressure symptoms and the hematoma was evacuated. The other patient was treated conservatively. No deaths or cranial or peripheral nerve injuries were observed in the CEA group. Restenosis was seen in a single case (3.2%) who underwent CAS, whereas no restenosis was seen in patients undergoing CEA. The mean length of stay after the procedure was similar in both the groups, i.e., 5.1 days for the CEA group and 4.8 days in the CAS group.
The patients included in this study are representative of patients routinely treated for symptomatic carotid stenosis in western India. The mean age of patients undergoing the treatment in our study was 62.2 years. The earlier presentation of carotid stenosis could be attributed to various factors such as genetic predisposition, geographical prevalence, and presence of more than two risk factors such as hypertension, diabetes, dyslipidemia as well as increased use of tobacco in all its forms. This has been supported by Kaul et al.[16],[17] who reported a mean age of patients presenting with carotid stenosis as 58.1 (±10.6 years) in their study. Hypertension (76.9%) was the most common risk factor associated with patients with carotid stenosis.[18] In our study, the primary outcome has been the incidence of 30-day stroke, major adverse events, and death rate. Perioperative stroke or MAEs rates in CEA limb (2.9%) were lower than those in CAS limb (6.4%); however, this was not statistically significant. The overall 30-day rate of disabling stroke and death was 3% in our study. A single death (3.2%) occurred in the CAS group. Our data is consistent with the findings of various multicentric studies [Table 3].
Another complication encountered in various studies was restenosis of the carotid artery. CAVATAS[20] and SPACE[10] study showed an excessive risk of restenosis or occlusion after endovascular treatment. By contrast, the rates of severe restenosis during long-term analysis did not differ between stenting and endarterectomy with other studies including our study [Table 4].
There has been a major debate over more suitable mode of treatment as well as sanctioned speciality authorized for the treatment of carotid artery stenosis. Nevertheless, it is established that high-risk patients with carotid artery stenosis should be considered for CAS. CAS and CEA have been performed across a wide range of specialities including interventional neurologist (IN), interventional radiologist (IR), cardiologist (IC), cardiothoracic surgeons (CT), vascular surgeons (VS), general surgeons (GS), and neurosurgeons (NS). CREST[13],[14] was a landmark study investigating the efficacy and safety of CAS with CEA. During the lead-in phase of CREST, periprocedural event rate occurring in patients undergoing CAS was lower when performed by a neuroradiologist (1.6%) in comparison to a cardiologist (3.9%) or a surgeon (7.7%). However, a substudy analysis of CREST could not identify significant differences in a composite outcome rate occurring with CAS performed by expert vascular surgeons compared to other listed operators.[15] With the results from CREST scrutinized and deliberated by experts in all these specialties,[15] there is a continuing debate as to whether operator specialty and experience affect outcomes when CEA and CAS are performed. Also, owing to arduous training norms in CREST, the relevancy of these findings has been probed while deducing these results across a distinct cadre of specialists performing CEA and CAS.[15] This is a vital topic. Hence, due consideration is given in the literature gauging the outcomes of these procedures, and comparisons have been made between various specialties. These studies have ventured in to determine which specialty and which setting offers the best outcomes and the least complications. AbuRahma et al.[22] showed the perioperative stroke rates for symptomatic patients undergoing CEA were 5.3%, 2.3%, and 2.2% for GS, CT, and VS, respectively. Vascular surgeons had the lowest stroke and/or death rates (3.9%) when Ruby et al.[23] compared VS, GS, CT, and NS; however, results were not statistically significant. Similarly, Kempczinski et al.[24] found no statistical difference with different surgical specialties. Hannan et al.[25] and Mattos et al.[26] found cumulative stroke rates and combined stroke/mortality rates substantially lower for VS. Similarly, few other studies have used regional and national databases to evaluate if operator specialty affects CAS outcomes. In the study of AbuRahma et al.,[27] 30-day rates of MAEs after CAS performed by different specialties were 3.1% with interventional cardiology, 6.3% with vascular surgeons, 7.1% with interventional radiologists, and 6.7% with interventional vascular medicine. Vogel et al.[28],[29] and Steppacher et al.[30] found that the stroke rate was not significantly different between specialties (VSs, cardiologists, and radiologists). Interestingly, however, surgeons had a lower mean total hospital cost, compared with radiology and cardiology. Sgroi et al.[31] separated the operators into surgeons and interventionalists, and the study demonstrated that the 30-day stroke/MI/death rates were not significantly different between the 2 groups. We juxtaposed our results following CAS and CEA performed by a single “dual-trained” neurosurgeon with those outlined in CREST and above-mentioned studies. The 30-day primary outcome rate of stroke and rate of death after perioperative stroke in addition with long-term outcomes of restenosis at 1 year were comparable with these multicentric trials [Table 3] and [Table 4]. Similar results have been previously obtained and published by Grimm et al and Rizwan et al.[32],[33] who reviewed the results by a single vascular surgeon. Simultaneously, our results obtained by a single “dual-trained” neurosurgeon were comparable with various studies comparing the outcomes of different specialities. Thus, our study supports that there is a “clinical and statistical equilibrium” between CEA and CAS performed by a neurosurgeon and further reinforces that dual-trained/hybrid neurosurgeons with the highest expertise in both fields can offer a more proficient service for neurovascular diseases as compared to other specialties. Our study represents first of its kind data of a single “dual-trained” neurosurgeon and helps in a generalization of the result encountered with various randomized trials such as CREST or SPACE[10],[13],[14] in treating symptomatic carotid stenosis by a single “dual-trained” neurosurgeon in a community setting. The dictum “Primum non nocere” forms the cornerstone in approaching a patient with carotid stenosis. A hybrid or a “dual-trained” neurosurgeon presents a cafeteria approach for the management of carotid stenosis, especially in a country like India. Herewith, we propose the following salient points to be considered by a “dual-trained” neurosurgeon while treating a case with carotid stenosis. Recommendations for management of carotid stenosis by a “dual-trained” neurosurgeon [Figure 4]
Optimal medical therapy alone should be commenced in: Several CAS-only trials such as CAPTURE and GORE, etc., as well as randomized trials comparing CEA and CAS, are further required in refining the criteria for CAS before it is propagated as a safer alternative to CEA for symptomatic carotid stenosis.[34],[35]
Limitations Our study is a retrospective analysis and the best evidence to evaluate the advantage of subgroup treatment can be acquired from a meta-analysis of contemporary trials that compare stenting with endarterectomy. Our study did not evaluate the procedural outcome, hospital charges, or length of stay between specialties in our hospital, but we may consider evaluating these in the future in our patient cohort. In addition, to review the literature for the better specialty for the treatment of carotid stenosis depending on caseload was out of the purview of this article. Declaration of patient consent The authors certify that they have obtained all appropriate patient consent forms. In the form, the patients have given their consent for their images and other clinical information to be reported in the journal. The patients understand that their names and initials will not be published and due efforts will be made to conceal their identity, but anonymity cannot be guaranteed. Financial support and sponsorship Nil. Conflicts of interest There are no conflicts of interest.
[Figure 1], [Figure 2], [Figure 3], [Figure 4]
[Table 1], [Table 2], [Table 3], [Table 4]
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