Shared Decision-Making Note (Carotid Revascularization)

Date/Time: [Date and time of SDM discussion]

Location: [clinic / inpatient / telehealth]

Author: [Name, credentials, role]

Decision Focus: [One-sentence statement of the specific decision, e.g., "Revascularization approach for symptomatic right ICA stenosis"]

Participants and Capacity

Patient: [Patient name or "patient"] — [has decision-making capacity / lacks capacity: reason and assessment timing]

Surrogate/POA: [Name, relationship, basis for authority] (If applicable; omit if patient has capacity and is deciding independently)

Others present: [Family/friends: names and relationships / none]

Interpreter: [Language and modality / not needed]

[Patient/surrogate] had opportunity to ask questions and was free from coercion. [Key questions or concerns raised, if any]

Clinical Context

(Include only details that materially affect option comparison. If stenosis severity or symptom status is uncertain, explicitly state what is pending and note that the decision is preliminary.)

• Carotid disease: [Side], [vessel], [stenosis severity and measurement method], [imaging source and date]
• Symptom status: [Symptomatic: qualifying event, date, residual deficits / Asymptomatic]
• Current medical therapy: [Antiplatelet agent(s)], [statin intensity], [BP control status], [smoking status], [other relevant risk factor management]
• Factors affecting option selection: [Age], [cardiac risk], [renal function], [DAPT tolerance: confirmed / intolerance history / unknown], [neck anatomy: prior surgery, radiation, high lesion], [arch anatomy if relevant to stenting], [other pertinent factors]
• Pending items: [Tests or information awaited that may affect final decision] (Omit if none)

Options Discussed

(Document all medically reasonable options. CMS requires discussion of CEA, CAS/TCAR, and optimal medical therapy before CAS. If an option is not appropriate for this patient, state why rather than omitting.)

Optimal Medical Therapy Alone

• Components: [Antiplatelet plan], [statin and lipid goals], [BP targets], [smoking cessation], [other interventions]
• Expected benefit: [Stroke risk reduction with OMT]; Residual risk: [Estimated ipsilateral stroke risk without revascularization]
• Surveillance: [Duplex interval], [clinical follow-up schedule]
• Suitability for this patient: [Factors favoring or disfavoring OMT alone]

Carotid Endarterectomy (CEA)

• Expected benefit: [Stroke prevention benefit for this patient given symptom status and stenosis severity]
• Material risks discussed: [Stroke], [death], [MI], [cranial nerve injury: nerves at risk, transient vs permanent], [wound/airway complications], [other patient-specific risks]
• Suitability for this patient: [Anatomy considerations: hostile neck, prior radiation, high lesion], [anesthesia considerations], [cardiac risk], [other factors favoring or disfavoring CEA]

Carotid Artery Stenting (CAS/TCAR)

• Approach considered: [Transfemoral CAS / TCAR]
• Benefits: [Less invasive], [shorter recovery], [avoids neck incision and cranial nerve risk], [other patient-specific benefits]
• Material risks discussed: [Periprocedural stroke/embolization], [access complications], [contrast-related risks], [bradycardia/hypotension], [restenosis], [other patient-specific risks]
• DAPT requirement: [Agents and duration planned]; [Tolerance: confirmed / unknown—requires resolution before final decision]
• Suitability for this patient: [Age considerations], [arch/access anatomy], [renal function], [other factors favoring or disfavoring CAS]

Deferral or Watchful Waiting

(Include if discussed as distinct option; omit if not applicable)

• Rationale: [Clinical reasons to defer]
• Plan: [Duration], [surveillance], [criteria prompting intervention]

Clinician Recommendation

[Recommended approach: CEA / transfemoral CAS / TCAR / OMT alone / true equipoise]. [One to two sentences linking recommendation to patient-specific clinical factors and guideline considerations. If equipoise, specify which factors are preference-sensitive.]

Patient Goals and Preferences

(Include at least one direct quote or clearly attributed statement.)

• Stated priorities: [Patient's goals relevant to this decision] — "[Direct quote capturing key value or preference]"
• Risk tolerance: [Prioritizes stroke prevention vs avoiding procedures; tolerance for procedural risk vs long-term risk]
• Practical considerations: [DAPT willingness], [recovery time concerns], [caregiver/support considerations]
• If preferences unclear: [Reason and supportive steps taken: decision aids, additional counseling, caregiver involvement] (Omit if preferences were clearly articulated)

Assessment of Understanding

• Teach-back: [What patient/surrogate was able to explain back about options, benefits, risks, and tradeoffs; gaps identified and clarified]
• Key questions asked: [Salient questions and how addressed]
• Educational materials: [Decision aids, handouts, diagrams provided] (Omit if none)
• SDM structure: [Single visit / multiple visits: summarize prior discussions if applicable]

Decision and Next Steps

Decision: [Proceed with CEA / Proceed with transfemoral CAS / Proceed with TCAR / Continue OMT alone / Defer decision pending specific information / Patient declines intervention]

Rationale: [One sentence linking clinical factors and patient preferences to chosen approach]

If proceeding with revascularization: Timing: [urgent / elective; target window if symptomatic]. Pre-procedure requirements: [labs, cardiac clearance, anesthesia evaluation, DAPT initiation]. Scheduling: [target date or next steps].

If not proceeding now: OMT optimization: [specific actions]. Surveillance: [duplex interval, clinic follow-up]. Return precautions: [stroke/TIA symptoms requiring emergency evaluation].

Conditional items to resolve: [e.g., confirm stenosis severity, DAPT tolerance, renal optimization, imaging review] (Omit if decision is final)

CMS SDM Attestation

(Complete when CAS/TCAR is planned, especially for Medicare beneficiaries.)

• [x] Indication criteria met: symptom status and stenosis severity documented
• [x] All required options discussed: CEA, CAS/TCAR, and optimal medical therapy
• [x] Patient-specific risks and benefits discussed for each option
• [x] Clinical guideline considerations integrated
• [x] Patient preferences and priorities elicited and incorporated
• [x] SDM completed prior to planned procedure date

This SDM documentation does not replace the facility's required procedure consent form.