Indications
| Indication | PE Category | Notes |
|---|---|---|
| Massive PE with hemodynamic instability (SBP <90, vasopressors, cardiac arrest) + contraindication to systemic lysis | Massive | CDT or mechanical first-line; if no contraindication, systemic lysis is faster and simpler |
| Massive PE failed systemic thrombolysis | Massive | Mechanical aspiration (FlowTriever) preferred; surgical embolectomy as alternative |
| High-risk submassive PE (RV/LV >0.9 + troponin + BNP + worsening on anticoagulation) | Submassive | PERT evaluation; CDT or EKOS vs. continued anticoagulation; shared decision-making |
| Submassive PE with high clot burden (bilateral central/lobar thrombus) | Submassive | Consider for rapid RV decompression; mechanical aspiration an option |
| Contraindication to systemic thrombolysis but requiring clot reduction | Any | Large-bore mechanical aspiration without tPA (FlowTriever, Penumbra) |
| Saddle PE with severe RV strain | Massive/Submassive | Central PE with bilateral involvement; high risk of decompensation |
Contraindications
| Type | Contraindication |
|---|---|
| Absolute (to thrombolytics — mechanical options still available) | Active intracranial hemorrhage · Prior hemorrhagic stroke (any time) · Ischemic stroke <3 months · Intracranial neoplasm · Active internal bleeding · Recent brain/spine surgery <3 months |
| Relative (to CDT) | Recent major surgery <10 days · Recent major trauma · Pregnancy · Severe thrombocytopenia · Prolonged CPR · BP >185/110 uncontrolled · Bacterial endocarditis |
Key distinction: Absolute contraindications apply to thrombolytics (CDT, EKOS), not to mechanical aspiration. Patients with prior hemorrhagic stroke or recent intracranial surgery who require urgent PE intervention are candidates for large-bore mechanical thrombectomy (FlowTriever, Penumbra Indigo) without tPA.
2026 AHA/ACC PE Clinical Categories
| Category | Definition | Management / Advanced Therapy |
|---|---|---|
| A | Asymptomatic / incidental PE | Outpatient anticoagulation; advanced therapy not indicated |
| B | Symptomatic, low severity (PESI ≤85 or sPESI 0–1) | Early discharge; DOAC preferred; advanced therapy not indicated |
| C1 | Elevated severity score; no RV dysfunction and no biomarker elevation | Hospitalization; anticoagulation; advanced therapy not indicated |
| C2 | Elevated severity score + biomarker elevation OR RV dysfunction (not both) | Hospitalization; PERT consultation; close monitoring |
| C3 | Elevated severity score + biomarker elevation AND RV dysfunction | Advanced therapy can be considered (Class 2b) |
| D1–D2 | Incipient cardiopulmonary failure — transient hypotension or normotensive shock | Advanced therapy can be considered (Class 2b) |
| E1 | Persistent hypotension (SBP <90 for >15 min, vasopressors required) | Advanced therapy reasonable (Class 2a); systemic lysis first-line if no contraindication |
| E2 | Cardiac arrest or refractory cardiogenic shock | VA-ECMO; surgical embolectomy if available |
The 2026 AHA/ACC guidelines replace the old massive/submassive/low-risk framework with this 8-category system. IR consultation is most relevant from Category C3 onward. The old term "massive PE" roughly corresponds to E1; "submassive" now maps to C3–D. Advanced therapies include CDT, mechanical thrombectomy, systemic thrombolysis, and surgical embolectomy — choice is individualized based on contraindications, center expertise, and PERT team recommendation.
Devices and Approaches
| Device | Type | Key Feature | Evidence |
|---|---|---|---|
| Inari FlowTriever | Large-bore mechanical aspiration | 24 Fr system; no tPA required; rapid RV decompression via nitinol disc clot engagement + aspiration | FLARE trial (n=106): 57.9% RV/LV reduction at 48h; no device-related major adverse events |
| Penumbra Indigo | Large-bore aspiration | 8/12 Fr options; CAT8/CAT12 catheters; Lightning Flash aspiration technique | EXTRACT-PE: successful revascularization 97.5%; RV/LV ratio improved; no symptomatic ICH |
| EKOS (EkoSonic) | Ultrasound-accelerated CDT | 5.2 Fr catheter; high-frequency ultrasound accelerates fibrin dissociation; lower tPA dose than systemic | ULTIMA: EKOS vs. anticoagulation; OPTALYSE-PE: dose optimization (4–24 mg tPA total) |
| AngioJet | Rheolytic thrombectomy | High-velocity saline jets macerate and aspirate thrombus; PE-TRAC protocol for pulmonary use | ⚠️ FDA black box warning: serious cardiopulmonary adverse events including death reported when used in pulmonary arteries. 20–30% risk of heart block/bradycardia from adenosine release. Largely supplanted by FlowTriever and Penumbra for PE. |
| CDT alone | Pharmacologic (catheter only) | Multi-side-hole catheter; prolonged tPA infusion without mechanical assist | Historical baseline; largely replaced by EKOS or mechanical aspiration in current practice |
Relevant Anatomy
Right heart access follows a predictable course from the femoral or jugular vein: right femoral vein or right internal jugular vein → inferior or superior vena cava → right atrium → tricuspid valve → right ventricle → pulmonic valve → main pulmonary artery → right and left pulmonary arteries.
- Normal PA pressures: 15–25 mmHg systolic, 8–15 mmHg diastolic; mean <25 mmHg. In acute massive PE, PA systolic pressure is typically <60 mmHg — the acutely dilated RV cannot generate higher pressures against a sudden obstruction. This distinguishes acute PE from chronic pulmonary hypertension where PA pressures can exceed 60–80 mmHg.
- RV pathophysiology in PE (death spiral): Acute obstruction → RV pressure overload → RV dilation → interventricular septal shift leftward → LV underfilling → systemic hypotension → RV ischemia → further RV dilation → progressive hemodynamic collapse. Recognizing this cycle is the rationale for urgent RV decompression.
- Clot distribution patterns: Saddle PE = thrombus straddling the main PA bifurcation bilaterally; massive = main PA + lobar involvement; submassive = lobar and/or segmental branches.
- Key imaging landmark: RV/LV diameter ratio measured on axial CT at the widest point — ratio ≥0.9 defines RV dysfunction and is the primary CT criterion for submassive PE requiring escalation beyond anticoagulation.
Procedure Overview
The following is a high-level summary. Full device setup, catheter navigation to pulmonary arteries, mechanical aspiration technique, EKOS catheter placement, hemodynamic monitoring parameters, and post-procedure ICU management protocols are available in RadCall Pro.
- Access: Right femoral vein preferred for most cases; right internal jugular vein for a direct, shorter approach. Sheath size 8–24 Fr depending on device selected.
- Hemodynamic monitoring setup: Arterial line mandatory for continuous blood pressure monitoring; PA pressure measured via pigtail or Swan-Ganz catheter; document right heart pressures before and after intervention.
- Main pulmonary angiogram: Pigtail catheter positioned to main PA; inject 30 mL at 20 mL/sec; AP view + ipsilateral oblique projections; confirm clot distribution and extent bilaterally.
- Catheter navigation to PA branches: Directional catheter (multipurpose or pigtail) + hydrophilic wire. Right PA accessed with slight clockwise rotation; left PA with counterclockwise. Navigate carefully to avoid precipitating arrhythmia in an already-stressed RV.
- Device deployment: FlowTriever — position 24 Fr access catheter, advance system to clot, engage with nitinol discs, connect aspiration syringe; Penumbra — advance CAT8/12 to clot face, apply continuous aspiration with Lightning technique; EKOS — bilateral catheter placement in right and left PA thrombus (2 catheters placed simultaneously is standard); CDT — multi-side-hole catheter spanning thrombus.
- tPA dosing (if CDT/EKOS): 0.5–1 mg/hr per catheter; current EKOS protocols recommend 1 mg/hr per catheter for 6–24h; maximum dose per current protocols 12–24 mg total (vs. 100 mg systemic).
- Hemodynamic reassessment: Serial PA pressure measurements during procedure; improvement in RV/LV ratio and PA pressure = technical success endpoint.
- Completion angiogram: Document before/after clot reduction; confirm bilateral PA patency.
- Heparin anticoagulation: Continue throughout procedure and CDT infusion; target PTT 60–80 sec during CDT phase.
- Sheath removal: After fibrinogen normalizes (if CDT/EKOS used); manual compression or closure device at access site.
⚠️ AngioJet — FDA Black Box Warning in PE: The FDA has issued a black box warning for AngioJet use in pulmonary arteries due to risk of serious cardiopulmonary adverse events, including death. Rheolytic thrombectomy in the PA causes adenosine release during clot maceration, producing a 20–30% rate of heart block and severe bradycardia. If AngioJet is used in the pulmonary arteries: atropine 0.5–1 mg IV must be immediately available, temporary pacing capability should be on standby, and activation time should be minimized. Most operators now prefer FlowTriever or Penumbra Indigo as first-line mechanical options for PE specifically because of this safety profile.
Complications
| Complication | Rate | Management |
|---|---|---|
| Intracranial hemorrhage | 1–2% (CDT); <0.5% (mechanical) | CT head immediately; neurosurgery consultation; reverse anticoagulation; stop lysis |
| Major bleeding (non-intracranial) | 4–8% (CDT); ~2% (mechanical) | Stop lysis; transfuse; surgical intervention if intractable bleeding source |
| Cardiac perforation / tamponade | <1% | Pericardiocentesis; surgical repair if hemodynamically unstable |
| Pulmonary artery dissection | Rare | Avoid excessive wire force in segmental PA branches; stenting rarely required |
| Arrhythmia / cardiac arrest (AngioJet) | 20–30% heart block; deaths reported (FDA black box warning) | Atropine 0.5–1 mg IV immediately available; temporary pacing on standby; minimize activation time; FlowTriever/Penumbra preferred for PE |
| Access site complications | 5–8% | Manual compression; rarely requires surgical repair |
| PE worsening / PEA arrest during manipulation | During procedure in extremis patients | Atropine and vasopressors immediately available; ECMO team backup at centers managing high-risk cases |
Post-Procedure Care and Follow-up
- ICU admission with continuous hemodynamic monitoring: PA pressure trend, systolic blood pressure, heart rate, SpO2, and urine output as indicators of RV recovery.
- Repeat echocardiogram at 24h: Assess RV normalization — goal RV/LV <0.9 and recovery of normal RV wall motion; persistent RV dilation suggests incomplete treatment or recurrent PE.
- Anticoagulation: LMWH or unfractionated heparin infusion → transition to DOAC at 24–48h (rivaroxaban or apixaban; 3–6 months minimum for provoked PE; indefinite for unprovoked or recurrent VTE).
- Imaging follow-up: CT pulmonary angiography at 3 months if initial PE was high-risk; V/Q scan at 3–6 months if persistent dyspnea or exercise intolerance to evaluate for chronic thromboembolic pulmonary hypertension (CTEPH).
- CTEPH screening: If persistent dyspnea, exercise intolerance, or elevated PA pressures at 3–6 months after PE: V/Q scan (more sensitive than CT-PA for CTEPH) + echocardiography + right heart catheterization to confirm diagnosis. Referral to CTEPH specialist center if confirmed.
Evidence Summary
2026 AHA/ACC Guideline Recommendations
The 2026 AHA/ACC/ACCP/ACEP/CHEST/SCAI/SHM/SIR/SVM/SVN Guidelines define specific indications for CDT and MT by clinical category. Advanced therapies are indicated based on category rather than a single hemodynamic threshold.
Catheter-Directed Thrombolysis (CDT):
- Category E1 (persistent hypotension, SBP <90 for >15 min) — Reasonable (Class 2a). Systematic review/meta-analysis of 594 patients suggested catheter-based techniques are associated with improved survival to discharge.
- Categories D1–D2 (incipient cardiopulmonary failure) — Can be considered (Class 2b). Small RCTs demonstrated CDT relieves RV dysfunction faster than anticoagulation alone (measured by RV/LV ratio), with low major bleeding risk.
- Categories C2–C3 (RV dysfunction ± biomarkers, hemodynamically stable) — Not routinely indicated. Low risk of deterioration on anticoagulation alone; CDT has not been powered to show clinical deterioration reduction in this population; likely carries higher major bleeding risk than anticoagulation alone.
Mechanical Thrombectomy (MT):
- Category E1 — Reasonable (Class 2a). FLAME study (n=115) showed primary composite endpoint of 17% vs. prespecified performance goal of 32% (p<0.01), with 1.9% in-hospital mortality.
- Categories D1–D2 — Can be considered (Class 2b). FLARE: 25% RV/LV reduction at 48h, 1% major bleeding. EXTRACT-PE: significant RV/LV reduction, 1.7% major bleeding. FLASH registry (n=1,000): significant improvements in PA pressure, RV/LV ratio, and RV systolic function.
- Categories C2–C3 — Not routinely indicated, for the same reasons as CDT.
CDT vs. MT — Choosing Between Approaches:
The PEERLESS trial (RCT; n=550; Categories C2–D2) found no significant difference in 30-day mortality or major bleeding between MT and CDT. A combined endpoint of clinical deterioration plus physician-driven bailout was more frequent with CDT; clinical deterioration alone was not significantly different. The 2026 guidelines recommend choice be guided by operator experience, anatomic clot location, perceived urgency, and patient comorbidities. MT offers a thrombolytic-free option particularly advantageous in patients with elevated bleeding risk.
Clot-in-Transit:
Free-floating intracardiac thrombus (found in 2–4% of PE diagnoses) is independently associated with mortality (OR 2.26). Advanced therapies — CDT, MT, systemic thrombolysis, and surgical embolectomy — should all be considered; high-quality comparative data are lacking, and multidisciplinary decision-making is essential.
Landmark Trials
| Trial | Design / N | Key Findings |
|---|---|---|
| HI-PEITHO (2026, NEJM) | Multinational RCT; n=544; ultrasound-assisted CDT vs. anticoagulation; intermediate-risk PE (RV/LV ≥1.0 + troponin + ≥2 of: SBP ≤110, HR ≥100, or RR >20) | Primary composite (PE-related death, cardiorespiratory decompensation, or symptomatic recurrence at 7 days): 4.0% vs. 10.3% (RR 0.39; 95% CI 0.20–0.77; p=0.005). No ICH in either arm. Major bleeding 4.1% vs. 2.2% (p=0.32, NS). First adequately powered RCT demonstrating a clinical endpoint benefit from CDT in intermediate-risk PE (roughly Categories C3–D). |
| PEERLESS (2025) | RCT; n=550; large-bore MT vs. CDT; intermediate-risk PE (Categories C2–D2) | No significant difference in 30-day mortality or major bleeding. Combined clinical deterioration + bailout endpoint more frequent with CDT. Establishes MT as a thrombolytic-free alternative with equivalent mortality to CDT. |
| FLAME | Prospective single-arm; n=115; MT for high-risk PE (Category E1) | Primary composite (mortality, bailout, deterioration, major bleeding): 17% vs. performance goal of 32% (p<0.01). In-hospital mortality: 1.9%. Established MT as effective for E1 when systemic lysis fails or is contraindicated. |
| FLARE (2019) + FLASH registry | FLARE: n=106; FlowTriever; intermediate-risk PE. FLASH: n=1,000; FlowTriever registry | FLARE: RV/LV ratio reduced 25% at 48h; no device-related major adverse events; no ICH. FLASH: PA pressure decreased 7.6 mmHg (−23.0%); RV/LV ratio 1.23→0.98 at 48h. |
| EXTRACT-PE (2022) | Prospective single-arm; Penumbra Indigo; intermediate-risk PE | Successful revascularization 97.5%; RV/LV ratio significantly improved; no symptomatic ICH; thrombolytics avoided in 98.3% of patients. Major bleeding 1.7%; 30-day mortality 2.5%. |
| EKOS ULTIMA (2015) + SUNSET sPE | ULTIMA: RCT; EKOS vs. anticoagulation; submassive PE. SUNSET sPE (2023): RCT; EKOS vs. conventional catheter | ULTIMA: EKOS superior for RV/LV reduction at 24h (1.28→0.99 vs. 1.20→1.17; p<0.001); no major bleeding. SUNSET: conventional multiside-hole catheters equivalent to EKOS at 48h — device choice can be guided by operator familiarity and institutional availability. |
| OPTALYSE-PE (2018) / SEATTLE II (2015) | OPTALYSE: RCT; 4 EKOS dosing regimens (4–24 mg tPA; 2–6h). SEATTLE II: single-arm; n=150; massive + submassive PE | OPTALYSE: 12 mg/6h protocol noninferior to longer regimens — now standard EKOS protocol. SEATTLE II: RV/LV 1.55→1.13; PA systolic 51.4→36.9 mmHg; 1 symptomatic ICH/150 patients. |
| PEITHO (2014, NEJM) | RCT; n=1,006; systemic tenecteplase vs. anticoagulation; submassive PE | Systemic lysis reduced death/hemodynamic decompensation (2.6% vs. 5.6%) but ICH 2.0% vs. 0.2%. The ICH burden drove interest in catheter-directed alternatives — now validated by HI-PEITHO. Rescue systemic thrombolysis remains appropriate for patients who decompensate on anticoagulation alone. |
CDT vs. Systemic Thrombolysis vs. Anticoagulation
Network meta-analyses (2023) comparing all three strategies across intermediate- and high-risk PE populations:
| Comparison | Mortality OR | Major Bleeding OR | ICH OR |
|---|---|---|---|
| CDT vs. Systemic thrombolysis | 0.43 (0.32–0.57) | 0.61 (0.53–0.70) | 0.44 (0.29–0.64) |
| CDT vs. Anticoagulation alone | 0.36 (0.25–0.52) | 1.24 (0.88–1.75, NS) | 1.33 (0.63–2.79, NS) |
| Systemic thrombolysis vs. Anticoagulation | 1.14 (NS) | Higher | Higher (NNH=78) |
Additional Guideline Perspectives
- Rescue therapy after failed systemic thrombolysis: ESC, AHA/ACC, and ACCP all support CDT or MT as rescue after systemic lysis failure or when systemic lysis is contraindicated (ESC Class IIa; MT or CDT as alternative to surgical embolectomy).
- Elevated bleeding risk: MT is preferred over CDT when thrombolytics must be avoided — no indwelling catheter, no lytic infusion, avoids post-procedure ICU for lysis monitoring. EXTRACT-PE avoided thrombolytics in 98.3% of patients.
- Intermediate-risk with signs of impending deterioration (AHA 2019 Scientific Statement): Hemodynamically stable patients with elevated PESI/sPESI, severe PE-related functional impairment, or objective signs of diminished end-organ perfusion and nonprohibitive bleeding risk may be considered for CDT. MT is an option for those with elevated bleeding risk.
- HI-PEITHO inclusion criteria as a practical selection tool: The trial enrolled patients with RV/LV ≥1.0, elevated troponin, plus ≥2 of: SBP ≤110, HR ≥100, or RR >20. This high-acuity intermediate-risk profile (roughly Categories C3–D) defines the population with the strongest current RCT evidence for CDT benefit.
Advanced Therapy Indications — Summary
| Clinical Scenario | CDT | MT | Class |
|---|---|---|---|
| Category E1 — Persistent hypotension (SBP <90 for >15 min) | ✓ | ✓ | 2a — Reasonable |
| Categories D1–D2 — Incipient cardiopulmonary failure | ✓ | ✓ | 2b — Can be considered |
| Category C3 — RV dysfunction + biomarkers, hemodynamically stable | Not routine | Not routine | Not routinely indicated |
| Failed systemic thrombolysis | ✓ | ✓ | 2a (ESC) |
| Contraindication to systemic thrombolysis | ✓ | ✓ (preferred) | 2a–2b |
| Elevated bleeding risk | Caution | ✓ (preferred) | Expert consensus |
| Clot-in-transit | ✓ | ✓ | Expert consensus |
Bottom line: CDT (HI-PEITHO, 2026) and MT (PEERLESS, FLAME) now have RCT-level evidence for intermediate- and high-risk PE. CDT has the only positive RCT for clinical endpoints (not just hemodynamic surrogates) in intermediate-risk PE. MT is the preferred thrombolytic-free approach. For E1 without contraindications, systemic tPA remains fastest. PERT team involvement is the critical process-of-care factor — no single therapy is universally superior.
References
- Creager MA, Barnes GD, Giri J, et al. 2026 AHA/ACC/ACCP/ACEP/CHEST/SCAI/SHM/SIR/SVM/SVN Guideline for the Evaluation and Management of Acute Pulmonary Embolism in Adults. J Am Coll Cardiol. 2026;87(13):1626–1710. doi:10.1016/j.jacc.2025.11.005.
- Dudzinski DM, Cibotti-Sun M, Moore MM. 2026 Acute Pulmonary Embolism Guideline-at-a-Glance. J Am Coll Cardiol. 2026;87(13):1620–1625. doi:10.1016/j.jacc.2025.12.023.
- Rosenfield K, Klok FA, Piazza G, et al. Ultrasound-Facilitated, Catheter-Directed Fibrinolysis for Acute Pulmonary Embolism (HI-PEITHO). N Engl J Med. 2026. doi:10.1056/NEJMoa2516567.
- Plett S, Fidelman N, et al. ACR Appropriateness Criteria® Management of Acute Pulmonary Embolism. J Am Coll Radiol. 2025;22(11S):S586–S596. doi:10.1016/j.jacr.2025.08.039.
- Zuin M, Bikdeli B, Ballard-Hernandez J, et al. International Clinical Practice Guideline Recommendations for Acute Pulmonary Embolism: Harmony, Dissonance, and Silence. J Am Coll Cardiol. 2024;84(16):1561–1577. doi:10.1016/j.jacc.2024.07.044.
- Piazza G. Advanced Management of Intermediate- and High-Risk Pulmonary Embolism: JACC Focus Seminar. J Am Coll Cardiol. 2020;76(18):2117–2127. doi:10.1016/j.jacc.2020.05.028.
- Giri J, Sista AK, Weinberg I, et al. Interventional Therapies for Acute Pulmonary Embolism: AHA Scientific Statement. Circulation. 2019;140(20):e774–e801. doi:10.1161/CIR.0000000000000707.
- Sista AK, et al. FLARE Trial. JACC Cardiovasc Interv. 2019;12(9):859–869.
- Moriarty JM, et al. EXTRACT-PE. Circ Cardiovasc Interv. 2022;15:e011846.
- Kucher N, et al. ULTIMA. Eur Heart J. 2015;36(10):597–604.
- Piazza G, et al. SEATTLE II. JACC Cardiovasc Interv. 2015;8(10):1382–1392.
- Tapson VF, et al. OPTALYSE-PE. JACC Cardiovasc Interv. 2018;11(14):1401–1410.
- Meyer G, et al. PEITHO. N Engl J Med. 2014;370(15):1402–1411.
- Planer D, et al. CDT vs. Systemic Thrombolysis and Anticoagulation in PE: Network Meta-Analysis. CMAJ. 2023;195(24):E833–E843.
- Zhang RS, et al. Efficacy and Safety of Anticoagulation, CDT, or Systemic Thrombolysis in Acute PE. JACC Cardiovasc Interv. 2023;16(21):2644–2651.
Full technique in RadCall Pro
Complete device setup, catheter navigation to pulmonary arteries, mechanical aspiration technique, EKOS placement protocol, hemodynamic monitoring parameters, and ICU management in RadCall Pro.
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