Is the requested inpatient stay and deep venous arterialization (DVA) medically necessary for a patient with critical limb-threatening ischemia (CLTI) and a history of hypertension (HTN), hyperlipidemia (HLD), heart failure with reduced ejection fraction (HFrEF), diabetes mellitus (DM), end-stage renal disease (ESRD), and peripheral artery disease (PAD)?

DETERMINATION: APPROVED - Deep Venous Arterialization with Inpatient Stay is Medically Necessary

For this 55-year-old male with CLTI, tissue loss, extensive calcific disease, ESRD on peritoneal dialysis, and no conventional revascularization options, deep venous arterialization (DVA) with inpatient admission is medically necessary and represents appropriate limb salvage therapy. 1

Rationale for Medical Necessity

CLTI Diagnosis and Urgency Met

• Patient presents with CLTI and tissue loss (bilateral toe amputations with ongoing wounds), which constitutes a limb-threatening emergency requiring urgent revascularization 1
• The 2024 ESC Guidelines explicitly state: "In CLTI patients, it is recommended to perform revascularization as soon as possible" (Class I, Level B recommendation) 1
• Early recognition and referral to vascular team for limb salvage is a Class I recommendation 1

DVA as Appropriate "No-Option" Therapy

• DVA is specifically indicated for CLTI patients with no conventional revascularization options due to absence of distal target vessels or inadequate conduit 2, 3
• CTA demonstrates "extensive calcific disease throughout both lower extremity arterial systems," consistent with no-option CLTI 2, 3, 4
• Vascular ultrasound was performed specifically to assess venous anatomy for DVA feasibility, indicating appropriate pre-procedural planning 2, 3
• The 2024 ESC Guidelines recommend that "endovascular treatment may be considered as first-line therapy, especially in patients with increased surgical risk or inadequate autologous veins" (Class IIb) 1

High-Risk Patient Profile Supports DVA Over Open Surgery

• Patient has multiple high-risk comorbidities that favor endovascular approach over open bypass: 1
  • ESRD on peritoneal dialysis (significantly increases perioperative mortality)
  • HFrEF (heart failure with reduced ejection fraction)
  • Diabetes with A1c 7.6%
  • Failed kidney transplant
  • New supraventricular tachycardia
• ACC/AHA guidelines explicitly state: "Patients with cardiac ischemia, cardiomyopathy, congestive heart failure, severe lung disease, or renal failure are known to be at greater risk for adverse perioperative events. It is generally accepted that in such patients, initial percutaneous revascularization, if feasible, is preferred over surgical approaches" 1

Evidence Supporting DVA Outcomes

• Recent studies demonstrate DVA achieves limb salvage rates of 81% at 1 year in no-option CLTI patients 5
• Complete wound healing rates reach 62.5% at 6 months in appropriately selected patients 5
• The ALPS multicenter study and PROMISE I trial showed encouraging results with improved limb salvage and wound healing 3
• Approximately 23% of patients facing major amputation are eligible candidates for DVA based on anatomic criteria 4

Inpatient Stay Justification

Medical Necessity for Inpatient Setting

APPROVED: 2-3 days inpatient stay

• Complex high-risk patient requires inpatient monitoring: 1

  • ESRD on peritoneal dialysis necessitates careful fluid management and dialysis coordination
  • HFrEF requires cardiac monitoring during procedure and recovery
  • New SVT requires rhythm monitoring
  • Diabetes management during NPO status and procedure

• DVA procedure complexity warrants inpatient care: 2, 3

  • Novel technique requiring specialized post-procedural monitoring
  • Need for immediate assessment of DVA patency and limb perfusion
  • Risk of compartment syndrome post-revascularization requires close monitoring 6, 7
  • Potential for acute complications requiring rapid intervention

• Post-procedural monitoring requirements: 1, 6

  • Clinical assessment of limb perfusion and neurological status
  • Monitoring for compartment syndrome (requires emergent fasciotomy if develops) 6, 7
  • Assessment of wound status and tissue viability
  • Anticoagulation management in ESRD patient
  • Pain control in complex patient

Guideline Support for Inpatient Care

• The 2024 ESC Guidelines mandate "regular follow-up" and assessment of "clinical, haemodynamic and functional status" after CLTI revascularization 1
• ACC/AHA guidelines emphasize that CLI management "must be determined on a case-by-case basis" considering "urgency of clinical presentation" and "presence of comorbidity" 1
• This patient's multiple high-risk comorbidities (ESRD, HFrEF, new arrhythmia) combined with novel DVA procedure clearly justify inpatient monitoring 1

Common Pitfalls to Avoid

• Do not delay revascularization: CLTI requires urgent intervention to prevent progression and amputation 1
• Monitor for compartment syndrome: Post-revascularization compartment syndrome requires emergent fasciotomy 6, 7
• Ensure adequate anticoagulation: Immediate systemic anticoagulation unless contraindicated, with careful dosing in ESRD 6
• Coordinate dialysis schedule: PD patient requires coordination of procedure timing with dialysis needs
• Assess DVA patency early: Early detection of DVA failure allows for prompt reintervention 1, 5

Days Approved: 2-3 Days

Recommended inpatient stay: 2-3 days to allow for:

• Day 0-1: Procedure performance and immediate post-procedural monitoring
• Day 1-2: Assessment of DVA patency, limb perfusion, wound status, and complication surveillance
• Day 2-3: Coordination of dialysis, medication optimization, and discharge planning with close outpatient follow-up

1, 6, 2, 3, 5