Complications of Embolization Procedures and Their Management
Εισαγωγή
Embolization procedures have become integral to the practice of interventional radiology, offering minimally invasive solutions for a wide range of clinical conditions, including hemorrhage control, tumor treatment, management of vascular malformations, and symptomatic relief from benign conditions. These techniques involve the selective occlusion of blood vessels using various embolic agents delivered via catheters under imaging guidance. While generally safe and effective, embolization procedures are not without risks, and complications can occur, ranging from minor self-limiting issues to severe, life-threatening events.
A thorough understanding of the potential complications associated with embolization procedures is paramount for interventional radiologists and referring clinicians. This knowledge allows for appropriate patient selection, informed consent, meticulous procedural technique to minimize risks, early recognition of adverse events, and prompt, effective management when complications arise. The spectrum of complications can be broadly categorized into those related to vascular access, non-target embolization, specific embolic agent effects, and systemic responses.
The incidence and severity of complications vary depending on the specific procedure being performed, the vascular territory involved, the patient’s underlying condition and comorbidities, the type of embolic agent used, and the experience of the operator. For instance, embolization in the neurovascular system carries different risks compared to embolization for uterine fibroids or gastrointestinal bleeding. Similarly, the use of liquid embolic agents like N-butyl cyanoacrylate (NBCA) or ethanol carries a different risk profile compared to particulate agents or coils.
This comprehensive review aims to provide a detailed overview of the potential complications associated with embolization procedures across various clinical applications. It will cover the classification of complications, mechanisms underlying their occurrence, risk factors, preventive strategies, diagnostic approaches, and management principles. By fostering a deeper understanding of these potential adverse events, this review seeks to enhance patient safety and optimize outcomes in the field of interventional embolotherapy.
Ιατρική αποποίηση ευθύνης:
Classification of Embolization Complications
Temporal Classification
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Intraprocedural Complications:
- Occur during the embolization procedure itself.
- Examples: Vessel dissection, perforation, acute non-target embolization, allergic reaction to contrast.
- Require immediate recognition and management.
-
Periprocedural Complications (within 24-72 hours):
- Occur shortly after the procedure.
- Examples: Access site hematoma, post-embolization syndrome, acute organ dysfunction.
- Often related to the immediate effects of embolization or access.
-
Delayed Complications (days to weeks):
- Manifest later after the procedure.
- Examples: Abscess formation, delayed non-target effects, embolic agent migration.
- May relate to tissue response or secondary effects.
-
Long-Term Complications (months to years):
- Develop over an extended period.
- Examples: Chronic pain, organ dysfunction, foreign body reaction, recanalization.
- Often related to permanent tissue changes or embolic material persistence.
Etiological Classification
-
Access-Related Complications:
- Related to arterial or venous puncture and sheath placement.
- Examples: Hematoma, pseudoaneurysm, arteriovenous fistula, thrombosis, infection.
-
Catheter/Wire-Related Complications:
- Resulting from manipulation of catheters and guidewires.
- Examples: Vessel dissection, perforation, vasospasm, thromboembolism.
-
Contrast-Related Complications:
- Adverse reactions to iodinated contrast media.
- Examples: Allergic reactions (mild to anaphylaxis), contrast-induced nephropathy (CIN).
-
Embolization Agent-Related Complications:
- Specific effects of the chosen embolic material.
- Examples: Non-target embolization, agent migration, inflammatory reactions, specific toxicities (e.g., ethanol neurotoxicity).
-
Target Organ Ischemia/Infarction Complications:
- Resulting from occlusion of the target vessel supply.
- Examples: Post-embolization syndrome, organ dysfunction, tissue necrosis, abscess formation.
-
Non-Target Embolization Complications:
- Inadvertent occlusion of vessels supplying normal tissues.
- Examples: Stroke, spinal cord injury, skin necrosis, bowel ischemia, cranial nerve palsy.
-
Systemic Complications:
- Generalized physiological responses.
- Examples: Sepsis, pulmonary embolism (paradoxical), systemic inflammatory response syndrome (SIRS).
Severity Classification (e.g., Society of Interventional Radiology – SIR Classification)
- Grade A: No therapy, no consequence.
- Grade B: Nominal therapy, no consequence (e.g., overnight observation).
- Grade C: Requires therapy, minor hospitalization (<48 hours).
- Grade D: Requires major therapy, unplanned increase in level of care, prolonged hospitalization (>48 hours).
- Grade E: Permanent adverse sequelae.
- Grade F: Death.
Access Site Complications
Hematoma
- Incidence: 1-10% (most common access complication).
- Μηχανισμός: Bleeding from puncture site into surrounding soft tissues.
- Risk Factors: Large sheath size, inadequate compression, anticoagulation, obesity, hypertension, multiple punctures.
- Presentation: Localized pain, swelling, ecchymosis.
- Diagnosis: Clinical examination, ultrasound if large or expanding.
- Management: Manual compression, pressure dressing, observation. Large or expanding hematomas may require surgical evacuation.
- Prevention: Proper puncture technique, adequate compression (manual or device-assisted), careful patient selection.
Pseudoaneurysm
- Incidence: <1-2%.
- Μηχανισμός: Arterial puncture site fails to seal, leading to a contained collection of blood communicating with the arterial lumen, bounded by surrounding tissues.
- Risk Factors: Similar to hematoma, low puncture site, inadequate compression.
- Presentation: Pulsatile mass, pain, bruit over the site.
- Diagnosis: Duplex ultrasound (confirmatory), CT angiography if complex.
- Management: Ultrasound-guided compression, ultrasound-guided thrombin injection (most common), surgical repair for large or rapidly expanding pseudoaneurysms.
- Prevention: Optimal puncture location (over femoral head), adequate compression.
Arteriovenous (AV) Fistula
- Incidence: <1%.
- Μηχανισμός: Simultaneous puncture of adjacent artery and vein, creating an abnormal connection.
- Risk Factors: Low puncture site, multiple attempts, obesity.
- Presentation: Palpable thrill, audible bruit, potential limb swelling or high-output heart failure (rare, chronic).
- Diagnosis: Duplex ultrasound, angiography if intervention planned.
- Management: Observation (many close spontaneously), ultrasound-guided compression, endovascular repair (covered stent), surgical ligation.
- Prevention: Ultrasound guidance for access, careful needle advancement.
Arterial Thrombosis/Occlusion
- Incidence: <1%.
- Μηχανισμός: Thrombus formation at the puncture site or due to intimal injury, leading to vessel occlusion.
- Risk Factors: Small vessel caliber, prolonged sheath time, hypercoagulable state, severe atherosclerosis, dissection.
- Presentation: Acute limb ischemia (pain, pallor, pulselessness, paresthesia, paralysis).
- Diagnosis: Clinical examination, ankle-brachial index (ABI), duplex ultrasound, angiography.
- Management: Anticoagulation, catheter-directed thrombolysis, mechanical thrombectomy, surgical embolectomy/bypass.
- Prevention: Careful technique, adequate anticoagulation during procedure if needed, minimizing sheath time.
Μόλυνση
- Incidence: <1%.
- Μηχανισμός: Bacterial contamination during puncture or sheath placement.
- Risk Factors: Poor sterile technique, prolonged sheath time, immunocompromised state, diabetes.
- Presentation: Local erythema, warmth, tenderness, purulent discharge, fever, sepsis (rare).
- Diagnosis: Clinical examination, wound culture, blood cultures if systemic signs.
- Management: Antibiotics, local wound care, drainage of abscess if present, removal of infected foreign material (rarely needed for diagnostic sheaths).
- Prevention: Strict sterile technique.
Catheter and Guidewire Related Complications
Arterial Dissection
- Incidence: 1-3%.
- Μηχανισμός: Intimal injury caused by guidewire or catheter tip, creating a false lumen.
- Risk Factors: Atherosclerotic disease, vessel tortuosity, forceful manipulation, inappropriate catheter/wire selection.
- Presentation: Often asymptomatic, may cause flow limitation leading to ischemia, pain.
- Diagnosis: Angiography (intimal flap, contrast staining in false lumen).
- Management: Often conservative (observation, anticoagulation if flow-limiting). Stenting may be required for flow-limiting dissections or those involving critical vessels.
- Prevention: Careful wire/catheter manipulation, use of hydrophilic wires, appropriate catheter sizing.
Vessel Perforation
- Incidence: <1%.
- Μηχανισμός: Guidewire or catheter tip penetrates the vessel wall.
- Risk Factors: Aggressive manipulation, stiff wires, small or diseased vessels.
- Presentation: Contrast extravasation on angiography, pain, potential for hematoma or hemoperitoneum/hemothorax depending on location.
- Diagnosis: Angiography.
- Management: Prolonged balloon tamponade, coil embolization of the perforation site, covered stent placement, surgical repair if severe or uncontrolled bleeding.
- Prevention: Gentle wire/catheter handling, use of soft-tipped wires in distal vessels.
Vasospasm
- Incidence: Variable, depends on vessel territory (more common in smaller arteries, e.g., cerebral, renal).
- Μηχανισμός: Vessel constriction in response to mechanical stimulation by catheter/wire or pharmacological agents.
- Risk Factors: Small vessel size, patient predisposition, certain medications.
- Presentation: Angiographic finding of vessel narrowing, potential for transient ischemia.
- Diagnosis: Angiography.
- Management: Intra-arterial vasodilators (e.g., nitroglycerin, verapamil, nicardipine), removal of stimulating catheter/wire, supportive care.
- Prevention: Gentle technique, prophylactic vasodilators in high-risk territories.
Thromboembolism
- Incidence: <1-2%.
- Μηχανισμός: Formation of thrombus on catheter/wire surface, which then embolizes distally, or dislodgement of existing plaque/thrombus.
- Risk Factors: Prolonged procedure time, inadequate flushing/anticoagulation, severe atherosclerosis, hypercoagulable state.
- Presentation: Acute ischemia in the territory supplied by the affected vessel (e.g., stroke, limb ischemia, organ infarction).
- Diagnosis: Clinical presentation, angiography, cross-sectional imaging.
- Management: Aspiration thrombectomy, catheter-directed thrombolysis, anticoagulation, supportive care.
- Prevention: Adequate heparinization during procedure, continuous saline flush through sheath/catheters, careful wire/catheter manipulation in diseased vessels.
Contrast Media Related Complications
Allergic-Like Reactions
- Incidence: Mild (0.5-3%), Moderate (0.1-0.5%), Severe/Anaphylaxis (<0.01-0.04%).
- Μηχανισμός: Not true IgE-mediated allergy for most reactions; likely direct histamine release or complement activation.
- Risk Factors: Prior reaction to contrast, history of asthma or atopy, certain medications (beta-blockers).
- Presentation: Mild (urticaria, pruritus, nausea), Moderate (diffuse urticaria, bronchospasm, facial edema), Severe (laryngeal edema, severe bronchospasm, hypotension, cardiovascular collapse).
- Diagnosis: Clinical presentation.
- Management: Mild (antihistamines), Moderate (antihistamines, bronchodilators, corticosteroids, epinephrine if progressing), Severe (epinephrine, airway management, IV fluids, vasopressors, intensive care).
- Prevention: Identify high-risk patients, consider alternative imaging, premedication protocol (corticosteroids, antihistamines), use of low-osmolar or iso-osmolar contrast agents.
Contrast-Induced Nephropathy (CIN)
- Incidence: Variable (2-12%), higher in high-risk patients.
- Μηχανισμός: Renal vasoconstriction and direct tubular toxicity leading to acute kidney injury (AKI).
- Definition: Increase in serum creatinine by >0.5 mg/dL or >25% from baseline within 48-72 hours post-contrast.
- Risk Factors: Pre-existing chronic kidney disease (CKD), diabetes mellitus, dehydration, large contrast volume, congestive heart failure, certain medications (NSAIDs, metformin).
- Presentation: Often asymptomatic rise in creatinine, oliguria in severe cases.
- Diagnosis: Monitoring serum creatinine post-procedure.
- Management: Supportive care, hydration, management of electrolyte abnormalities, dialysis if severe AKI develops.
- Prevention: Identify high-risk patients, adequate hydration (IV saline), minimize contrast volume, hold nephrotoxic medications, consider alternative contrast agents (e.g., CO2, gadolinium – with caution regarding NSF).
Complications Related to Embolic Agents and Target Organ Effects
Non-Target Embolization (NTE)
- Incidence: 1-5% overall, higher in specific procedures/territories.
- Μηχανισμός: Inadvertent delivery of embolic material to vessels supplying normal tissues due to reflux, passage through unrecognized collaterals or shunts, or misplacement of catheter.
- Risk Factors: Small particle size, high injection pressure, high-flow shunts, unrecognized anastomoses, unstable catheter position, poor visualization.
- Presentation: Varies by territory: Stroke, cranial nerve palsy (neurovascular); spinal cord injury (spinal); skin necrosis, muscle ischemia (peripheral); bowel ischemia, cholecystitis (visceral); pulmonary embolism (paradoxical).
- Diagnosis: Clinical symptoms, angiography, cross-sectional imaging.
- Management: Supportive care, specific therapies depending on organ affected (e.g., thrombolysis for stroke, hyperbaric oxygen for skin necrosis), management of sequelae.
- Prevention: Meticulous angiographic mapping, identification of dangerous anastomoses, super-selective catheterization, use of appropriate size/type of embolic agent, controlled injection technique, test injections, consideration of balloon occlusion or coils proximal to target.
Post-Embolization Syndrome (PES)
- Incidence: 20-90% (depends on procedure, e.g., high after TACE, UFE).
- Μηχανισμός: Inflammatory response to tissue ischemia and necrosis in the target organ.
- Presentation: Fever, pain, nausea, vomiting, malaise, leukocytosis. Typically occurs within 24-72 hours and resolves within 7-10 days.
- Diagnosis: Clinical diagnosis of exclusion (rule out infection, other complications).
- Management: Symptomatic and supportive care: Analgesics (opioids often required), antiemetics, antipyretics, IV hydration.
- Prevention: Patient education regarding expected symptoms, prophylactic antiemetics/analgesics in some protocols.
Target Organ Ischemia/Infarction and Dysfunction
- Μηχανισμός: Expected consequence of therapeutic embolization, but can be excessive or lead to unintended functional impairment.
- Presentation: Pain, organ-specific symptoms (e.g., elevated liver enzymes after TACE, transient renal insufficiency after renal embolization, neurological deficits after brain AVM embolization).
- Diagnosis: Clinical assessment, laboratory tests, imaging.
- Management: Supportive care, management of specific organ dysfunction, pain control. Severe infarction may lead to abscess or need for surgical intervention.
- Prevention: Careful patient selection, precise embolization technique to preserve maximal normal tissue, staged procedures for large volumes.
Abscess Formation
- Incidence: <1-5% (higher in tumor embolization, e.g., TACE).
- Μηχανισμός: Necrotic tissue from infarction becomes secondarily infected, or pre-existing infection exacerbated.
- Risk Factors: Large volume of necrosis, biliary manipulation (TACE), immunocompromised state, bowel ischemia.
- Presentation: Persistent fever, pain, leukocytosis beyond typical PES timeframe, sepsis.
- Diagnosis: Cross-sectional imaging (CT/MRI showing fluid collection with rim enhancement, gas), aspiration/culture.
- Management: Broad-spectrum antibiotics, percutaneous drainage, surgical debridement if necessary.
- Prevention: Sterile technique, prophylactic antibiotics in high-risk cases (e.g., biliary stents), prompt treatment of PES.
Embolic Agent Migration
- Incidence: Rare.
- Μηχανισμός: Dislodgement of embolic material (coils, particles) from the target site into systemic or pulmonary circulation.
- Risk Factors: Inadequate packing density, high-flow state, improper sizing of coils/particles, delayed recanalization.
- Presentation: Depends on location of migration (e.g., pulmonary embolism, stroke, peripheral emboli).
- Diagnosis: Imaging (radiographs for coils, CT/MRI).
- Management: Depends on location and clinical significance. Anticoagulation, endovascular retrieval if feasible and necessary, supportive care.
- Prevention: Proper sizing and dense packing of coils, use of appropriate particle size, ensuring stasis achieved.
Specific Agent-Related Toxicities
- Ethanol: Neurotoxicity (nerve damage), skin necrosis, severe pain, cardiovascular collapse (rare), pulmonary hypertension.
- NBCA (Glue): Catheter adhesion/retention, distal embolization if polymerization too slow, proximal occlusion if too fast.
- Bleomycin: Pulmonary fibrosis (rare with current doses), skin hyperpigmentation, flu-like symptoms.
- Doxycycline: Pain, teeth discoloration (children <8 years).
- Management: Agent-specific protocols, dose limitations, careful injection technique, supportive care.
- Prevention: Adherence to recommended doses and concentrations, awareness of specific risks, appropriate patient selection.
Territory-Specific Complications
Neurovascular Embolization (Aneurysms, AVMs, Tumors)
- Stroke/TIA: NTE, thromboembolism, vasospasm.
- Hemorrhage: Aneurysm rupture during coiling, AVM rupture (perfusion pressure breakthrough).
- Cranial Nerve Palsy: NTE to vasa nervorum.
- Seizures: Cortical irritation, ischemia.
- Vasospasm: Common, managed with vasodilators.
- Hydrocephalus: Post-hemorrhage or inflammatory.
Spinal Embolization (AVMs, Tumors)
- Spinal Cord Infarction/Myelopathy: NTE involving anterior spinal artery or radiculomedullary arteries (most feared complication, <1%).
- Radiculopathy: Nerve root ischemia.
- Vertebral Body Infarction/Collapse: Rare.
Head and Neck Embolization (Tumors, Epistaxis)
- Cranial Nerve Palsy: Facial, trigeminal, glossopharyngeal, vagus nerves.
- Skin/Mucosal Necrosis: NTE.
- Blindness: Ophthalmic artery embolization (rare).
- Stroke: Reflux into internal carotid artery.
- Trismus: Embolization of masticatory muscles.
Bronchial Artery Embolization (Hemoptysis)
- Spinal Cord Injury: Embolization of spinal artery branches arising from bronchial/intercostal arteries (<1-2%).
- Chest Pain: Common, usually transient.
- Dysphagia: Esophageal ischemia (rare).
- Bronchial Necrosis/Stenosis: Rare.
Hepatic Embolization (TACE, SIRT, Tumors)
- Post-Embolization Syndrome: Very common.
- Liver Failure: Particularly in patients with poor baseline function.
- Biliary Injury/Biloma: NTE to bile duct vasculature.
- Hepatic Abscess: Higher risk than other territories.
- Non-Target Embolization: Gastric/duodenal ulceration (NTE to gastroduodenal artery branches), pancreatitis, cholecystitis.
Renal Embolization (Tumors, AMLs, Trauma)
- Renal Infarction/Failure: Excessive embolization, NTE to normal parenchyma.
- Abscess: Infarcted tumor/tissue.
- Hypertension: Renin-mediated, usually transient.
- Flank Pain: Common (PES).
Uterine Fibroid Embolization (UFE)
- Post-Embolization Syndrome: Very common.
- Amenorrhea/Ovarian Failure: NTE to ovarian arteries (<1-5%, risk increases with age >45).
- Endometritis/Pyometra: Rare.
- Fibroid Expulsion: Can be symptomatic.
- Uterine Necrosis/Perforation: Very rare.
Prostatic Artery Embolization (PAE)
- Post-Embolization Syndrome: Common but usually mild.
- Non-Target Embolization: Bladder wall ischemia/necrosis, rectal ischemia, penile skin ischemia (rare with current techniques).
- Urinary Retention: Transient.
- Hematuria/Hemospermia: Transient.
Gastrointestinal Bleeding Embolization
- Bowel Ischemia/Infarction: NTE, excessive embolization, poor collateral supply (5-15% risk, higher in certain locations).
- Rebleeding: Incomplete embolization, collateral development.
- Abscess: Infarcted bowel wall.
Trauma Embolization (Pelvic, Solid Organ)
- Non-Target Embolization: Gluteal necrosis, sciatic nerve injury (pelvic); organ infarction (liver, spleen, kidney).
- Abscess: Embolized hematoma or devitalized tissue.
- Rebleeding: Incomplete embolization, missed source.
Prevention and Management Strategies
Pre-Procedural Prevention
- Επιλογή ασθενούς: Careful risk-benefit analysis, assessment of comorbidities, identification of high-risk anatomy.
- Informed Consent: Detailed discussion of potential complications and their likelihood.
- Imaging: Thorough pre-procedural imaging review (CT/MRI/Angiography) to understand vascular anatomy, identify variants and dangerous collaterals.
- Medication Review: Adjustment of anticoagulants/antiplatelets, management of nephrotoxic drugs.
- Prophylaxis: Hydration for CIN prevention, premedication for contrast allergy, prophylactic antibiotics in selected high-risk cases.
- Team Briefing: Discussion of potential risks and bailout strategies.
Intra-Procedural Prevention
- Τεχνική: Meticulous sterile technique, optimal access site selection (ultrasound guidance), gentle wire/catheter manipulation.
- Angiographic Mapping: Comprehensive diagnostic angiography, identification of target vessels and critical non-target vessels/anastomoses.
- Catheter Positioning: Stable, super-selective catheter position distal to dangerous collaterals.
- Embolic Agent Selection: Appropriate type and size for target vessel and flow conditions.
- Injection Technique: Controlled, slow injection under continuous fluoroscopic monitoring, frequent checks for reflux, test injections with contrast.
- Bailout Strategies: Availability of retrieval devices, occlusion balloons, covered stents, reversal agents.
- Monitoring: Hemodynamic monitoring, neurological assessment when appropriate.
Post-Procedural Management
- Monitoring: Close observation for access site issues, signs of ischemia, neurological changes, vital signs.
- Post-Embolization Syndrome Management: Anticipatory guidance, aggressive symptom control (pain, nausea).
- Access Site Care: Adequate hemostasis, monitoring for hematoma/pseudoaneurysm.
- Hydration: Continued hydration for CIN prevention.
- Early Recognition: High index of suspicion for complications, prompt investigation of unexpected symptoms.
- Multidisciplinary Collaboration: Consultation with relevant specialists (e.g., surgery, neurology, infectious disease) for complication management.
Διαχείριση συγκεκριμένων επιπλοκών
- Non-Target Embolization: Supportive care, anticoagulation, hyperbaric oxygen, targeted therapies (e.g., thrombolysis for stroke), surgical intervention if needed.
- Vessel Injury (Dissection/Perforation): Balloon tamponade, coil embolization, covered stent, surgical repair.
- Thromboembolism: Aspiration/mechanical thrombectomy, thrombolysis, anticoagulation.
- Infection/Abscess: Antibiotics, percutaneous drainage, surgical debridement.
- Organ Dysfunction: Supportive care, specific organ support (e.g., dialysis, ventilation), management of underlying cause.
Συμπέρασμα
Embolization procedures represent a powerful tool in the armamentarium of modern medicine, offering minimally invasive treatment options for a diverse array of conditions. However, their effectiveness is balanced by a spectrum of potential complications, ranging from minor access site issues to severe, life-altering events like stroke or limb loss due to non-target embolization. A comprehensive understanding of these risks, coupled with meticulous technique and vigilant monitoring, is essential for optimizing patient safety and procedural outcomes.
Preventing complications begins with careful patient selection and thorough pre-procedural planning, including detailed imaging assessment to delineate complex vascular anatomy and identify potential hazards. Intraprocedurally, adherence to best practices—including super-selective catheterization, appropriate embolic agent selection, controlled injection techniques, and continuous monitoring—is critical to minimize the risk of adverse events, particularly non-target embolization. Post-procedurally, prompt recognition and management of complications, including post-embolization syndrome and access site issues, are crucial.
The risk profile varies significantly depending on the vascular territory being treated and the specific procedure performed. Neurovascular and spinal embolizations carry inherent risks of devastating neurological injury, demanding the highest level of technical precision and anatomical understanding. Visceral and peripheral embolizations carry risks of organ ischemia and tissue necrosis. Familiarity with territory-specific complications allows for tailored preventive measures and management strategies.
Ultimately, minimizing complications in embolization requires a combination of technical expertise, sound clinical judgment, continuous learning, and a multidisciplinary approach. As technology evolves with new embolic agents, imaging techniques, and catheter systems, ongoing evaluation of safety profiles and refinement of techniques will remain paramount. By prioritizing patient safety through rigorous attention to detail at every stage of care, interventional radiologists can continue to harness the therapeutic potential of embolization while mitigating its inherent risks.
Ιατρική αποποίηση ευθύνης: Οι πληροφορίες που παρέχονται σε αυτό το άρθρο προορίζονται μόνο για εκπαιδευτικούς σκοπούς και δεν πρέπει να θεωρούνται ιατρικές συμβουλές. Πάντα να συμβουλεύεστε έναν εξειδικευμένο επαγγελματία υγείας για τη διάγνωση και τη θεραπεία ιατρικών καταστάσεων. Η Invamed παρέχει αυτές τις πληροφορίες για να βελτιώσει την κατανόηση των ιατρικών τεχνολογιών, αλλά δεν υποστηρίζει συγκεκριμένες θεραπευτικές προσεγγίσεις εκτός των εγκεκριμένων ενδείξεων για τις συσκευές της.