From anticoagulation to intervention: The expanding role of percutaneous therapies in pulmonary embolism

Table 1 Contemporary catheter-based options for acute pulmonary embolism

Device/system	Primary mechanism	Key technical characteristics	Typical venous access	PE indication status	Main advantages	Main limitations/risks
Pigtail catheters/peripheral balloon catheters	Mechanical clot disruption (fragmentation ± balloon maceration)	Small profile catheters (historically used); manual rotation over a wire; can be paired with local lytic infusion	Femoral or jugular	Not applicable	Simple, widely available, low cost; may provide rapid partial recanalization as a bridge	Fragmentation can push clot distally and potentially worsen obstruction; largely replaced by dedicated systems
Cragg-McNamara infusion catheter (Medtronic)	CDT	Multi-side-hole infusion catheter; multiple working lengths and infusion segments	Femoral	Yes	Dedicated infusion design; reliable local delivery without need for complex mechanical components	Requires prolonged infusion (commonly 12-24 hours); bleeding risk still present
Fountain infusion catheter (Merit Medical)	CDT	Multi-side-hole infusion system; variable infusion lengths	Femoral	No	Practical and relatively cost-efficient	Less robust PE-specific clinical evidence compared with some alternatives
Uni-Fuse (AngioDynamics)	CDT	Multi-side-hole infusion catheter; multiple infusion segment lengths	Femoral	Yes	Broad and uniform thrombolytic dispersion through side holes	Requires monitored infusion over many hours; bleeding risk persists
Pulse-spray infusion catheter (AngioDynamics)	CDT (pulsed delivery)	Side-hole catheter allowing bolus/pulsed lytic administration; can be used with fragmentation	Femoral	No	Can enhance drug penetration and shorten initial delivery phase	Limited PE-specific outcome data; still requires thrombolytic exposure
Bashir catheter (Thrombolex)	Hybrid: Mechanical clot disruption + local lytic delivery	Expandable basket with multiple micro-infusion points to distribute lytic within thrombus	Femoral	No	Multi-point drug delivery directly inside thrombus; may improve penetration	Limited clinical dataset and adoption; still involves thrombolytic use
EkoSonic (Boston Scientific)	Ultrasound-assisted CDT (USAT)	Dual-lumen catheter: Ultrasound core + thrombolytic infusion lumen; multiple treatment-zone lengths	Femoral or jugular	Yes	Ultrasound energy may loosen fibrin architecture, improving lytic penetration; allows lower-dose/shorter regimens	Higher cost; incremental clinical advantage vs standard CDT remains debated
Aspirex (Becton Dickinson)	Mechanical fragmentation + aspiration	Aspiration catheter designed for thrombus extraction (more often peripheral use)	Femoral	Yes, in European Union, not in United States	Straightforward concept; avoids systemic thrombolysis	May be less effective for organized/older thrombus; PE-specific evidence limited
AngioJet (Boston Scientific)	Rheolytic thrombectomy ± “power pulse” lytic injection	High-pressure saline jets fragment thrombus and create suction (Bernoulli effect); can be combined with local lytic injection	Femoral or jugular	Yes, in European Union; FDA boxed warning for PE	Rapid debulking with option for pharmacomechanical approach	Bradyarrhythmias, hemolysis, hemodynamic instability; safety concerns led to boxed warning in the United States
AngioVac (AngioDynamics)	Aspiration with extracorporeal veno-venous bypass	Large-bore aspiration cannula connected to external filtration and reinfusion circuit; requires perfusion support	Femoral + jugular (dual access)	No	Allows aspiration with reinfusion and limited net blood loss; useful for RA/IVC thrombus	Not designed for pulmonary artery thrombectomy; requires perfusion team; limited role in acute PE
AlphaVac (AngioDynamics)	Large-bore aspiration without extracorporeal support	Manual aspiration system; no bypass circuit; deliverable cannula with multiple configurations	Femoral or jugular	No	Avoids perfusion team; less complex than AngioVac	Clinical experience still limited; not established for chronic PE
FlowTriever (Inari Medical)	Large-bore aspiration ± mechanical extraction	Large aspiration catheters; nitinol mesh discs for clot engagement; optional blood filtration/reinfusion (FlowSaver)	Femoral or jugular	Yes	Effective for high clot burden; avoids thrombolytics; strong prospective trial and registry evidence	Large and relatively stiff system can limit distal branch reach; requires operator experience
Indigo aspiration system (Penumbra)	Aspiration + mechanical thrombus disruption	Continuous suction pump + separator wire; smaller, more flexible catheters; optional Lightning Suction-Control Technology	Femoral or jugular	Yes	Better navigation into distal pulmonary branches; automated suction control may reduce blood loss	No blood reinfusion/filtering; effectiveness may be lower for highly organized clot

CDT: Catheter-directed thrombolysis; USAT: Ultrasound-assisted thrombolysis; FDA: Food and Drug Administration; PE: Pulmonary embolism; RA: Right atrium; IVC: Inferior vena cava.

Table 2 Expected complications of catheter-based therapies for acute pulmonary embolism

Complication	Approximate frequency	Likely mechanism/trigger	Practical management
Acute hemodynamic decompensation (sudden hypotension/collapse)	Uncommon	Distal embolization after clot fragmentation increasing pulmonary vascular resistance; RV strain from prolonged catheter manipulation; arrhythmia or acute RV failure during intervention	Escalate vasopressors/inotropes; terminate or simplify catheter maneuvers; consider rescue thrombolysis if appropriate; mechanical support (e.g., VA-ECMO) when refractory
Mechanical injury to the tricuspid valve	Uncommon	Inadvertent aggressive valve crossing or repeated catheter passes causing acute tricuspid regurgitation or leaflet/chordal damage	Remove/withdraw catheter; echocardiographic evaluation; cardiac surgical consultation if severe structural injury
Cardiac perforation with pericardial tamponade	Rare	Guidewire or catheter perforation (RA/RV) during manipulation	Immediate pericardiocentesis; hemodynamic stabilization; surgical repair if persistent bleeding
Hemoptysis/pulmonary hemorrhage	Uncommon	Pulmonary artery branch injury (wire perforation or catheter trauma); reperfusion injury after rapid flow restoration; thrombolysis-related bleeding	Airway protection and ventilatory support (selective intubation if needed); stop/limit thrombolytics; reverse anticoagulation when required; endovascular measures (balloon tamponade, selective coiling) in focal injury
Pulmonary artery dissection (large branch)	Rare	Excessive catheter torque, stiff wire trauma, or device advancement in tortuous anatomy	Often conservative monitoring if stable; balloon angioplasty if flow-limiting; CTA follow-up when indicated
Systemic (paradoxical) embolization	Rare	Embolus passage through intracardiac shunt (e.g., PFO) or other right-to-left communication	Treat based on embolic territory (stroke/limb/visceral); multidisciplinary management; consider evaluation for shunt closure after stabilization
Non-pulmonary major bleeding	Uncommon	Thrombolytic exposure (CDT/USAT), excessive anticoagulation, or access-site bleeding	Stop thrombolysis; reverse heparin if necessary; manage bleeding source specifically (GI, GU, retroperitoneal, etc.)
Hemolysis and bradyarrhythmias (device-related)	Uncommon (device-dependent)	Mainly described with rheolytic systems (e.g., AngioJet): Hemolysis-mediated release of vasoactive mediators	Limit activation time; monitor rhythm closely; treat bradycardia/AV block; discontinue device if instability occurs
Vascular access complications (hematoma, pseudoaneurysm, venous injury)	Uncommon	Large-bore sheaths (especially thrombectomy platforms), inadequate ultrasound guidance, prolonged procedure	Ultrasound-guided access; closure/pressure; transfusion if needed; vascular surgery/interventional radiology when severe
Contrast-associated acute kidney injury	Uncommon	High contrast volume in unstable patients or baseline CKD	Minimize contrast; hydration if feasible; avoid nephrotoxins; monitor creatinine

RV: Right ventricle; RA: Right atrium; PFO: Patent foramen ovale; CDT: Catheter-directed thrombolysis; USAT: Ultrasound-assisted thrombolysis; CKD: Chronic kidney disease; VA-ECMO: Venoarterial extracorporeal membrane oxygenation; CTA: Computed tomography angiography; GI: Gastrointestinal; GU: Genitourinary; AV: Atrioventricular.

Table 3 Major clinical trials and registries evaluating catheter-based therapies for acute pulmonary embolism

Trial	Therapy/device	Study design	Population	Main findings
ULTIMA	UATh (EkoSonic)	RCT	Intermediate-risk PE	Significant improvement in RV/LV ratio at 24 hours compared with anticoagulation alone, without increased major bleeding
SEATTLE II	UATh	Prospective single-arm study	Massive and submassive PE	Improved RV function and pulmonary pressures, but higher thrombolytic dose associated with increased bleeding
OPTALYSE PE	UATh	Randomized dose-optimization trial	Intermediate-risk PE	Lower-dose and shorter-duration thrombolysis improved RV function with favorable bleeding profile
SUNSET-sPE	UATh vs standard CDT	RCT	Intermediate-risk PE	Similar thrombus reduction between techniques with low major bleeding rates
CANARY	CDT vs anticoagulation	RCT	Intermediate–high-risk PE	Trial terminated early; interim data supported safety and feasibility of CDT
HI-PEITHO	UATh (EkoSonic) + anticoagulation vs anticoagulation alone	RCT	Intermediate-risk PE with RV dysfunction and cardiorespiratory distress	UATh significantly reduced the composite endpoint of PE-related death, hemodynamic decompensation/collapse or recurrent PE at 7 days (4.0% vs 10.3%) without increased major bleeding or intracranial hemorrhage
KNOCOUT PE	UATh	Prospective registry	Intermediate-high and high-risk PE	Low rates of major bleeding and intracranial hemorrhage with improved RV function
FLARE	FlowTriever thrombectomy	Prospective multicenter trial	Intermediate-risk PE	Significant reduction in RV/LV ratio with low major bleeding and minimal ICU utilization
FLASH	FlowTriever thrombectomy	Prospective registry	Real-world PE population	Confirmed safety and effectiveness with low adverse event rates
FLAME	FlowTriever vs contemporary therapies	Prospective comparative study	High-risk PE	Lower in-hospital adverse outcomes and mortality with thrombectomy
EXTRACT-PE	Indigo aspiration system	Prospective multicenter trial	Intermediate-risk PE	Significant reduction in RV strain with low major bleeding rates
PEERLESS	FlowTriever vs CDT	RCT	Intermediate-risk PE	Mechanical thrombectomy reduced clinical deterioration and ICU utilization without increasing bleeding
STORM-PE	Mechanical thrombectomy + anticoagulation vs anticoagulation	RCT	Intermediate–high-risk PE	Greater improvement in RV/LV ratio and thrombus burden without excess major adverse events

UATh: Ultrasound-assisted thrombolysis; CDT: Catheter-directed thrombolysis; RCT: Randomized controlled trial; PE: Pulmonary embolism; RV: Right ventricle; LV: Left ventricular; ICU: Intensive care unit.

Table 4 Emerging catheter technologies and investigational systems in pulmonary embolism intervention

Device/platform	Concep/device principle	Regulatory position (United States/European Union)	Trial/registry name	Identifier	Sample size (n)
AlphaVac F18 (AngioDynamics)	Mechanical thrombectomy based on aspiration (no extracorporeal circuit)	FDA cleared; CE marked	APEX-AV	NCT05318092	122
Helo PE (Endovascular Engineering)	Combined clot disruption + aspiration thrombectomy	Not approved (United States); not approved (European Union)	ENGULF	NCT05597891	25
WOLF (Boston Scientific)	Controlled thrombus extraction using finger-like retrieval elements	Approved for peripheral arteries; not approved specifically for PE (United States); not approved (European Union)	N/A	N/A	N/A
JET (Abbott)	High-pressure saline jet to fragment thrombus and facilitate aspiration	Approved for peripheral arteries; not approved for PE (United States); not approved (European Union)	N/A	N/A	N/A
Laguna (Innova Vascular)	Hybrid mechanical disruption plus aspiration	Approved for peripheral arteries; not approved for PE (United States); not approved (European Union)	TRUST	NCT06041594	107 (estimated)
Cleaner Pro (Argon Medical Devices)	Pharmacomechanical approach combining thrombectomy with local lytic infusion capability	Approved for peripheral arteries; not approved for PE ((United States); not approved (European Union)	CLEAN-PE	NCT06189313	125 (estimated)
Katana (Akura Medical)	Rheolytic-powered aspiration with directional control features	Not approved (United States); not approved (European Union)	QUADRA-PE	NCT06672510	118 (estimated)
Magneto eTrieve (Magneto Thrombectomy Solutions)	Large-bore aspiration combined with electromechanical clot extraction	Not approved (United States); not approved (European Union)	Safety and Performance of Magneto PE Kit	NCT04949048	10

FDA: Food and Drug Administration; CE: European conformity; PE: Pulmonary embolism; N/A: Not applicable.