CIED Implantation Operative Note (Pacemaker/ICD/CRT)
Operative note template for cardiac implantable electronic device procedures including pacemakers, ICDs, and CRT systems. Structured for regulatory compliance with device traceability tables, numeric lead testing values,…
Document Type
clinical note / Operative Note
Specialties
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Procedure: [Explicit device type and laterality, e.g., "Dual-chamber permanent pacemaker implantation, left prepectoral" or "CRT-D upgrade with LV lead addition"]
Date: [Procedure date]; [Start time] to [End time]
Location: [Facility and procedural suite]
Operator: [Primary operator name and credentials] (Include assistants if applicable.)
Anesthesia: [local only / local with moderate sedation / MAC / general]
Device Type: [Pacemaker / ICD / CRT-P / CRT-D] (Note conduction system pacing if used: His bundle or left bundle branch area pacing.)
Urgency: [elective / urgent / emergent]
Indications and Diagnoses
[Indication narrative] (In 2–4 sentences, state the primary clinical indication and medical necessity. Include intended therapy and relevant objective data: rhythm or conduction abnormality, LVEF for ICD/CRT, NYHA class for CRT, or prior sustained VT/VF for secondary-prevention ICD.)
Pre-Procedure Diagnosis: [Diagnosis list]
Post-Procedure Diagnosis: [Diagnosis list]
Procedures Performed:
- [Procedure 1, e.g., dual-chamber pacemaker implantation]
- [Procedure 2, e.g., venography]
- [Additional procedures as applicable, e.g., coronary sinus cannulation, LV lead implantation]
Informed Consent: [Consent obtained with discussion of risks, benefits, and alternatives / Emergent procedure—document exception and clinical rationale]
Pre-Procedure Verification
- Time-out: Confirmed correct patient, procedure, site/side, allergies, antibiotic plan, and device strategy.
- Antibiotic Prophylaxis: [Agent and dose] administered [timing relative to incision]
- Anticoagulation/Antiplatelet Status: [Status and periprocedural plan, including hemostasis considerations]
- Existing System: [Existing device type and leads; pacemaker dependency status] (Include only for upgrades or revisions.)
Procedure Description
Positioning and Preparation: [Patient position]; [Monitoring applied]; [Sedation/anesthesia details]; skin prepared with [antiseptic agent]; sterile draping applied; [Local anesthetic agent and dose] infiltrated.
Incision and Pocket: [Side/laterality] [prepectoral subfascial / subcutaneous / submuscular] pocket created. [Approach relative to existing scar if revision.] Hemostasis achieved with [method]. [Infection-prevention adjuncts: antibacterial envelope and/or antibiotic irrigation solution if used.]
Venous Access: [Side]; access obtained via [cephalic cutdown / axillary puncture with fluoroscopic or ultrasound guidance / subclavian puncture / alternative route]. [Number of punctures and sheaths placed.] Venogram [performed/not performed]: [findings—patent, stenosis, occlusion, collaterals]. [Access complications and management, or "No access complications."]
Lead Implantation:
- [Lead purpose and chamber, e.g., RA pacing lead]: Positioned in [final anatomic location]; [active/passive] fixation [with confirmation method]; stability check performed; adequate slack confirmed; lead anchored to [fascia/muscle].
- [Lead purpose and chamber, e.g., RV pacing/defibrillation lead]: Positioned in [final anatomic location]; [active/passive] fixation [with confirmation method]; stability check performed; adequate slack confirmed; lead anchored to [fascia/muscle].
- (Include one bullet for each lead implanted or repositioned. For conduction system pacing, document evidence of capture such as QRS narrowing or LVAT shortening.)
Lead Testing: (Provide numeric values for all parameters. Do not use "WNL" or "normal.")
- [Lead type]: Sensing [value] mV; Threshold [value] V @ [value] ms; Impedance [value] ohms
- [Lead type]: Sensing [value] mV; Threshold [value] V @ [value] ms; Impedance [value] ohms
- (Add one bullet per lead. For ICD/CRT-D, include HV impedance and shock pathway configuration.)
- LV/CS Phrenic Nerve Stimulation: [Absent / Present] at [outputs and vectors tested] (Include for LV leads only.)
- (If sensing not assessed, state reason, e.g., "RA sensing not assessed—complete heart block with no intrinsic atrial rhythm.")
Generator Placement and Initial Programming: Generator placed in pocket; lead connections secured with torque wrench. Initial programming: [Mode], [Lower rate], [Pacing outputs]. (For ICD/CRT-D, include tachyarrhythmia detection zones and therapy configuration.)
Defibrillation Testing: (Include for ICD/CRT-D only. Document either "Performed" or "Omitted"—not both.)
- Performed: Induced via [method]; terminated successfully at [energy] J; [number] shock(s) required; [complications or "no complications"].
- Omitted: [Clinical rationale, e.g., initial left pectoral transvenous ICD with satisfactory sensing, impedance, and lead position per current guidelines.]
Imaging and Radiation: Fluoroscopy time: [value] minutes. [Reference air kerma: value mGy; Dose-area product: value if available.]
Closure: [Layered closure details]; hemostasis confirmed; pocket irrigated with [solution]; [Dressing type] applied. [Compressive dressing if used.] [Drain placement if applicable.]
Device Identification
(Complete identifiers required for traceability. If unavailable at dictation, state "pending implant log—completion required.")
Generator:
- Manufacturer: [value] | Model: [value] | Serial: [value] | UDI: [value] | Device Type: [value] | Laterality/Pocket: [value]
Leads:
- [Lead type]: Manufacturer: [value] | Model: [value] | Serial: [value] | UDI: [value] | Fixation: [active / passive]
- [Lead type]: Manufacturer: [value] | Model: [value] | Serial: [value] | UDI: [value] | Fixation: [active / passive]
- (Add one bullet per lead.)
Explanted Items: [Removed generator/lead with model, serial, and disposition] (For abandoned leads, state "abandoned in [location], secured." Omit this field if nothing removed.)
Findings and Outcomes
- Findings: [Notable venous anatomy, pocket findings, CS anatomy challenges if applicable]
- Estimated Blood Loss: [value] mL
- Specimens: [None / description]
- Complications: [No immediate complications observed / List each with management and patient status]
- Disposition: Patient [condition] at procedure end; transferred to [PACU / telemetry / ICU]; [rhythm and hemodynamic status]
Post-Procedure Plan
- Post-op device interrogation: [timing and parameters to confirm]
- Chest X-ray: [timing and views]
- Activity restrictions: [restrictions and duration per institutional protocol]
- Wound care: [per institutional protocol]
- Medications: [Post-op antibiotics with duration if applicable; anticoagulation/antiplatelet restart timing; pain management]
- Follow-up: Wound check [timing]; Device clinic [timing]
- Remote monitoring: [Enrollment status and setup plan]
- Device ID card provided to patient.
(Do not infer device details, lead positions, or testing results. If information was not measured, state "not obtained" with brief explanation. Use qualified language such as "no immediate complications observed." Omit inapplicable sections—e.g., omit Defibrillation Testing for pacemaker-only implants, omit Explanted Items if nothing removed.)
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