AI-Based Prediction Model for Iliofemoral DVT Thrombolysis

MRV-based Predischarge Venous Recanalization

The extent of venous recanalization in the acute phase after stent-free pharmacomechanical thrombolysis as measured by magnetic resonance venography, classified as complete (\>90% clearance), nearly complete (50-90% clearance), or partial (\<50% resolution)

Time frame: At hospital discharge (typically 3-7 days post-procedure)

At hospital discharge (typically 3-7 days post-procedure)

Quantified thrombus volume reduction from baseline to three-month follow-up as measured by magnetic resonance venography, with meaningful reduction defined as ≥50% volume decrease

Time frame: 3 months post-procedure

MRV-based Predischarge Percentage Reduction in Thrombus Volume

Quantified thrombus volume reduction from baseline to hospital discharge as measured by magnetic resonance venography, with meaningful reduction defined as ≥50% volume decrease

Time frame: At hospital discharge (typically 3-7 days post-procedure)

Postprocedural Acute Kidney Injury Occurrence

Development of acute kidney injury during hospitalization based on KDIGO criteria: ≥0.3 mg/dL increase in serum creatinine within 48 hours, ≥1.5x baseline creatinine increase, or urine output \<0.5 mL/kg/h for 6 hours.

Time frame: During index hospitalization (typically 3-7 days)

Need for New Renal Replacement Therapy

Requirement for initiation of any form of renal replacement therapy (hemodialysis, continuous veno-venous hemofiltration, peritoneal dialysis) due to acute kidney injury in patients without previous dialysis history.

Time frame: During index hospitalization (typically 3-7 days)

Postprocedural Oliguria or Anuria

Development of oliguria (urine output \<0.5 mL/kg/hour) or anuria (urine output \<50 mL/day) during the index hospitalization period.

Time frame: During index hospitalization (typically 3-7 days)

Postprocedural Hyperkalemia

Elevated serum potassium concentration above normal limits (\>5.0-5.5 mEq/L) during the index hospitalization period.

Time frame: During index hospitalization (typically 3-7 days)

Postprocedural Gross Hematuria

Presence of visible blood in urine detected by visual inspection or urine testing during the index hospitalization period.

Time frame: During index hospitalization (typically 3-7 days)

Major Bleeding Events

Major bleeding according to International Society of Thrombosis and Haemostasis (ISTH) definition: fatal bleeding, bleeding in critical organs, or bleeding causing ≥2.0 g/dL hemoglobin decrease or requiring ≥2 units red blood cell transfusion.

Time frame: During index hospitalization (typically 3-7 days)

Three-month Recurrent Venous Thromboembolism

Objectively confirmed recurrent symptomatic venous thromboembolism (deep vein thrombosis or pulmonary embolism) during the three-month follow-up period.

Time frame: 3 months post-procedure

Three-month Post-thrombotic Syndrome Incidence

Development of post-thrombotic syndrome defined as Villalta score ≥5, assessed through standardized evaluation of symptoms (pain, cramps, heaviness, paresthesia, pruritus) and clinical signs (edema, induration, hyperpigmentation, redness, venous ectasia, calf pain on compression).

Time frame: 3 months post-procedure

Three-month Post-thrombotic Syndrome Severity

Severity classification of post-thrombotic syndrome using Villalta score: mild (5-9), moderate (10-14), or severe (≥15 or venous ulceration).

Time frame: 3 months post-procedure

In-hospital All-cause Mortality

Death from any cause during the index hospitalization period.

Time frame: During index hospitalization (typically 3-7 days)

Three-month All-cause Mortality

Death from any cause during the three-month follow-up period.

Time frame: 3 months post-procedure

Technical Success Rate

Successful placement of the AngioJet device catheter and initiation of the thrombectomy procedure as intended per protocol.

Time frame: During the procedure