GL173-balloon-dilation-intracranial-vasospasm-61640-61642



In January 2018, these codes were moved to Guideline Note 173.CPT 61640-61642 Balloon dilation of intracranial vasospasm, percutaneousLast reviewed at VbBS in March, 2016. Minutes indicate that there was discussion about the HERC policy for removing a service from the Prioritized List. The subcommittee determined that balloon dilation of intracranial vasospasm should be removed from the List due to evidence of harm and placed on the Services Recommended for Non-Coverage Table.The following was presented in the meeting materials for the March, 2016 VbBS meeting:Question: Should balloon dilation of intracranial vasospasm be removed from the Prioritized List?Question source: HERC staffIssue: New CPT codes 61650 and 61651 (Endovascular intracranial prolonged administration of pharmacologic agent(s) other than for thrombolysis, arterial, including catheter placement diagnostic angiography, and imaging guidance) were reviewed at the November, 2015 VBBS/HERC meeting and were added to the Services Recommended for Non-Coverage Table due to lack of evidence of effectiveness for this therapy. During this review, HERC staff noted that the level and type of evidence for intracranial vasodilator therapy was similar to the evidence for intracranial balloon dilation for intracranial vasospasm. Currently, balloon dilation (CPT 61640-61642 Balloon dilation of intracranial vasospasm, percutaneous) appears on line 200 SUBARACHNOID AND INTRACEREBRAL HEMORRHAGE/HEMATOMA; CEREBRAL ANEURYSM; COMPRESSION OF BRAIN Treatment: BURR HOLES, CRANIECTOMY/CRANIOTOMY.Both Intracranial vasodilator therapy and balloon dilation are used for treatment of cerebral vasospasm after intracranial hemorrhage. The major treatment of cerebral vasospasm appears to be administration of medications via peripheral or central IV.In 2012, the use of balloon dilation of intracranial vasospasm for treatment of transient cerebral ischemia (TIA) was reviewed by HERC and found to be experimental.EvidenceAbruzzo 2012, review of the safety and efficacy of transluminal balloon angioplasty (TBA) and intra-arterial vasodilator infusion therapy (IAVT) for management of posthemorrhagic cerebral vasospasm (PHCV)N=12 studies for balloon angioplasty (361 patients)All studies case series, most retrospectiveN=7 studies for IAVT (109 patients)6 retrospective case series, 1 prospective case seriesMajor risks for balloon angioplasty identified, including cerebral artery rupture (reported to be 1-5% in large case series), thromboembolic complications (4-5% of cases), ischemic stroke, arterial dissectionThe technical efficacy of TBA reversing cerebral vasoconstriction in patients with PHCV is in the 80-100% range. Clinical series have reported improvements in TCD velocities, luminal caliber assessed by DSA and cerebral blood flow. More importantly, it has been demonstrated that TBA reduces neurological deficits in patients with PHCV and that early treatment (<2 h from symptom onset) significantly increases the probability of sustained clinical improvement. Technically successful restoration of normal or near normal luminal caliber is achieved in the majority of TBA procedures. Case series report angiographic improvement in 82-100% of patients. On the other hand, clinical success varies widely, with reversal of DCI in 31-77% of patients.There is no significant evidence that the intervention results in better long term clinical outcomes relative to medical management. TBA may be beneficial and may be considered for flow limiting PHCV involving the proximal intradural cerebral arteries (ICA, M1, VA, basilar artery, A1, P1) symptomatic with cerebral ischemia and refractory to maximal medical therapy. The assessment shows that for the indications described above, TBA and IAVT are classified as Class IIb, Level B interventions according to the American Heart Association guidelines, and Level 4, Grade C interventions according to the University of Oxford Centre for Evidence Based Medicine guidelines.Velat 2011, review and meta-analysis of therapies for intracranial vasospasmIdentified 1 RCT on prophylactic balloon angioplasty vs no treatment N=85 patients with balloon angioplasty vs 94 controlPatients undergoing prophylactic TBA experienced a non-significant reduction in DIND incidence (P=0.30). A significant decrease in therapeutic angioplasty (P = 0.03) was observed, however, for patients who had prophylactic TBA compared to controls. A high rate of vessel perforation was observed during the trial, resulting in three iatrogenic deaths.Although anecdotal reports suggest that TBA provides durable relief of vasospasm, no RCTs using therapeutic angioplasty alone have been published to date.Nimodipine is the only treatment that provided a significant benefit across multiple studies.Kimball 2011, review of endovascular management of cerebral vasospasm N=27 studies (1028 patients) for balloon angioplasty26 retrospective case series, 1 RCTIncluded prophylactic studies excluded from Abruzzo 2012. Concluded that “prophylactic treatment, however, has been associated with potential risks, and the data have not shown an improvement in clinical outcome after prophylactic treatment.” Improvements in vessel diameters as well as neurological deficits were observed in most studies following balloon angioplastyComplications of balloon angioplasty including vessel perforation, hemorrhage and deathIn summary, endovascular intervention for clinically identified vasospasm may be indicated as when medical management has failed or when there is a concern for complications from medical management.Expert guidelinesConolly 2012, AHA/ASA guidelines for management of subarachnoid hemorrhage (link to pdf included in November, 2015 packet)Oral nimodipine should be administered to all patients with aSAH (Class I; Level of Evidence AMaintenance of euvolemia and normal circulating blood volume is recommended to prevent DCI (Class I; Level of Evidence B). Prophylactic hypervolemia or balloon angioplasty before the development of angiographic spasm is not recommended (Class III; Level of Evidence B). Induction of hypertension is recommended for patients with DCI unless blood pressure is elevated at baseline or cardiac status precludes it (Class I; Level of Evidence B). Cerebral angioplasty and/or selective intra-arterial vasodilator therapy is reasonable in patients with symptomatic cerebral vasospasm, particularly those who are not rapidly responding to hypertensive therapy (Class IIa; Level of Evidence B). Deringer 2011, Neurocritical Care Society consensus statement (link to pdf included in November, 2015 packet)There was wide international variation in the use of endovascular therapies with some groups strongly recommending their use and other not utilizing them at allRecommendation: Endovascular treatment using intra-arterial vasodilators and/or angioplasty may be considered for vasospasm related DCI (moderate quality evidence-strong recommendation).Recommendation: The timing and triggers of endovascular treatment of vasospasm remains unclear, but generally rescue therapy for ischemic symptoms that remain refractory to medical treatment should be considered. The exact timing is a complex decision which should consider the aggressiveness of the hemodynamic intervention, the patients’ ability to tolerate it, prior evidence of large artery narrowing, and the availability of and the willingness to perform angioplasty or infusion of intra-arterial agents (moderate quality evidence—strong recommendation).Steiner 2013, European Stroke Organization guideline of treatment of subarachnoid hemorrhage (link to pdf included in November, 2015 packet)no recommendations for balloon?angioplasty or intra-arterial vasodilatorsSummary: Some preliminary evidence from retrospective case series finds that balloon angioplasty may be useful for treatment of intracranial vasospasm following aneurysmal subarachnoid hemorrhage, but its effectiveness needs to be verified by prospective RCTs. This procedure is recommended as a possible therapy after failure of optimal medical management by expert guidelines which rate the underlying evidence to be of low to moderate strength. There is risk of serious adverse events including arterial rupture and death from this procedure. The best available evidence does not find improvement in long term outcomes with balloon angioplasty vs optimal medical management.HERC staff recommendation:Option 1: Remove CPT 61640-61642 Balloon dilation of intracranial vasospasm, percutaneous) from line 200 SUBARACHNOID AND INTRACEREBRAL HEMORRHAGE/HEMATOMA; CEREBRAL ANEURYSM; COMPRESSION OF BRAIN and place on the Services Recommended for Non-Coverage TableEvidence shows efficacy at best similar to optimal medical managementEvidence of harm from treatment not seen with optimal medical managementOption 2: leave CPT 61640-61642 on line 200 and adopt the following new guideline noteThere is good evidence that prophylactic use is not effective and is harmfulExpert guidelines recommend use only with failure of optimal medical managementGuideline note XXX Balloon dilation of intracranial vasospasmLine 200Balloon dilation of intracranial vasospasm is included on this line only for patients with flow limiting posthemorrhagic cerebral vasospasm involving the proximal intradural cerebral arteries symptomatic with cerebral ischemia and refractory to maximal medical therapy. ................
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