2/3/2015 ASDIN ASDIN Classification System. Definition: an unanticipated adverse event that requires therapy

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1 //5 ASDIN Core Curriculum for Interventional Nephrology, Gerald A. Beathard, MD, PhD, FASN Interventional Nephrology,, McGraw-Hill Companies, Inc. Arif Asif, MD, FASN, FNKE Anil K. Agarwal, MD, FACP, FASN, FNFK Alexander S. Yevzlin, MD Stephen Wu, MD, FASN Gerald A. Beathard, MD, PhD, FACP, FCAP, FASN Definition: an unanticipated adverse event that requires therapy Endovascular procedures Standard of care in management of dialysis vascular access dysfunction Procedure techniques may result in procedure related complications Occur during or immediately after procedure VS Occur days or weeks after procedure ASDIN Classification System To grade complications specifically associated with vascular access procedures Identifies types of complications List not intended to be comprehensive/other types of complications may occur Type I II III IV V VI VII VIII IX X Complication Access site hematoma Vascular rupture Arterial complications Stent-related complications Catheter insertion complications Adverse reactions to medications Oxygen saturation and apnea Hypotension/hypertension Cardiac arrhythmia General clinical status ASDIN 5

2 //5 therapy required Unplanned increase in level of care to a nominal degree No clinical consequence or adverse sequelae therapy needed Successful management using percutaneous therapy No significant long-term sequelae therapy needed Persistent or unstable complication Surgical repair is required Hospitalization for observation or management of a complication Significant long-term (> days) sequelae Loss of limb or significant loss of limb function Death Classified procedural-related if develops during procedure or within hours post procedure Includes puncture sites related to procedure and those related to old puncture sites Description Therapy I Stable, size variable, does not continue to grow, does not affect flow Stable, size variable, slows or stops flow, therapy required Unstable, large extravasation or hematoma, size variablegenerally large, continues to expand (may be rapid), pulsatile, major therapy required Permanent loss of vascular access. Permanent impairment. Death, warm compress or similar therapy for symptoms, drug reversal (i.e. Protamine) Percutaneous treatment to stop hemorrhage: balloon tapenade/stent or stent graft placement Primary goal is stop progression, manual occlusion of access, stent graft, thrombose access, surgical repair or drainage, transfusion, hospitalization Most frequent procedure related complication associated with angioplasty of dialysis vascular access Inadvertent passage of guidewire, catheter, or other endovascular device through vascular wall Significance ranges none to disaster Extravasation of contrast, blood, or both Description Therapy Localized extravasation of contrast, self-limited, stable hematoma, no altered flow through vascular access Hematoma slows or stops flow, size variable, stable, minor therapy required Persistent hemorrhage, unstable (expanding) hematoma, thrombosis of vascular access (spontaneous or intentional) Permanent loss of vascular access. Permanent impairment. Death -may not require therapy, may have small ecchymosis over treated site day after therapy, patient may have tenderness at site Control hemorrhage by percutaneous therapy. Balloon tapenade. Stent or stent graft Surgery, hospitalization for observation or continued therapy Uncommon complication May occur during any percutaneous vascular access procedure Inadvertent arterial puncture can quickly lead to large, compressive hematoma Small arterial embolus (air or thrombus) Acute arterial rupture ASDIN 5

3 //5 Description Therapy Inadvertent cannulation of artery with no sequelae Arterial air embolus with no sequelae Inadvertent cannulation of artery Arterial air embolus Inadvertent cannulation of artery Arterial air embolus Permanent loss of vascular access Permanent impairment Death a. Percutaneous embolectomy required b. Arterial injury treated with balloon tapenade c. Arterial injury treated with stent or stent graft a. Surgical thrombectomy required b. Surgical repair of artery required c. Hospitalization for observation or continued therapy Complication of thrombectomy (mechanical or surgical) More commonly associated with graft thrombectomy than fistula thrombectomy Volume of thrombus in fistula small in most cases types of thrombus in occluded graft Firm, arterial plug Soft thrombus Residual thrombi present post endovascular thrombectomy even after graft is flowing Can be washed or pushed back across A anastomosis & into artery Over injection, especially if there is downstream occlusion Passage of guidewire across A anastomosis Most reported incidences are symptomatic True incidence much higher than documented Asymptomatic Recognized only radiographically Do not require treatment Hand ischemia symptoms Hand, especially fingers, turn cold, bluish discoloration, mottled Generally occur with sudden onset pain Compare Both Hands Optimal deployment requires selection of device with appropriate characteristics & optimal dimensions Undersized device-stent malposition, migration, suboptimal coverage of lesion Oversized-endoluminal folding of graft material obstructing blood flow Pulse at wrist absent/diminished Rigid-deform or crush in peripheral veins Doppler signal over arteries at wrist generally present though diminished. If absent-greater urgency for immediate treatment Physician error Device malfunction ASDIN 5

4 //5 Description Therapy Stent malposition not requiring second stent Malposition requiring nd stent Stent migration requiring nd stent/migrated stent in stable, benign position Stent migration requiring retrieval Acute thrombosis of stent Urgent surgery for stent removal required Hospitalization Permanent loss of vascular access Permanent impairment Death Description/Therapy a. Prolonged bleeding requiring nominal therapy b. Inadvertent needle puncture of artery or vein without sequelae c. Small hematoma (<cm) a. Mechanical problem secondary to insertion requiring return to procedure room for correction b. Prolonged bleeding requiring medical therapy c. Inadvertent insertion of catheter, sheath, or dilator into artery without sequelae d. Large hematoma (>cm) e. Exit site infection attributed to insertion procedure f. Vascular injury resolved with percutaneous therapy without sequelae g. Asymptomatic air embolus a. Bleeding requiring surgical intervention b. Embolization of catheter, guidewire, or other component used during insertion c. Tunnel infection attributable to insertion procedure d. Catheter related infection requiring antibiotics or catheter removal attributable to insertion procedure e. Symptomatic air embolism with resolution f. Pneumothorax requiring intervention g. Hospitalization for observation or continued therapy Life-saving surgery or permanent impairment a. Thoracotomy or laparotomy (femoral catheter) required for vessel repair b. Cardiac perforation or pericardial tampenade c. Death Risk Factors for Contrast Media Reactions History of allergies: -x increased risk Medications most commonly associated with interventional dialysis vascular access procedures Radiocontrast Sedation/analgesia Antibiotics Pulmonary conditions: asthma (-6x increased risk) Heart disease Hematological conditions: myeloma, sickle cell anemia Drugs: nonsteroidal anti-inflammatory drugs (NSAIDS), beta blockers Antibiotic group most commonly associated with adverse reactions History of previous contrast reactions: -5X increased risk Most frequently occurring medication reaction is to radiocontrast Renal insufficiency Endocrine conditions: thyroid disease, pheochromocytoma anxiety The W s (Risk Factors for Death) White Women Wrinkled (elderly) Weakened (debilitating medical conditions) ASDIN 5 Mild Moderate Severe Dizziness Bronchospasms (mild) Convulsions Headache Head/chest/abdomen pain Cyanosis Nausea/vomiting Hypo/hypertension Paralysis Pain at injection site Severe vomiting Profound hypotension Rash/pruritus Tachy/bradycardia Unresponsiveness Urticaria (limited) Thrombophlebitis Cardiopulmonary arrest Warmth Cutaneous reactions/extensive urticaria Pulmonary edema Diaphoresis Facial and laryngeal edema arrhythmias

5 //5-7 days after contrast injection -% incidence when followed for week after contrast administered Symptoms Identify history of reaction-note nature of reaction and type of agent Consider other modalities (CO, ultrasound, surgical Thrombectomy) Mild can progress quickly to severe Recognize early Most serious occur in st minutes Well stocked crash cart Personnel certified in ACLS and BLS Flu-like GI Skin reactions (more common)-diffuse, itchy macular rash & peeling to face, hands, feet Angioedema Hypotension & wheezing occur rarely Prednisone 5mg PO, 7, & hour prior to study + diphenhydramine 5mg IV/PO/IM hour prior to study Methylprednisone mg PO at and hours prior to study with or without diphenhydramine 5mg hour prior to study Breakthrough reactions can still occur in % of patients Stay calm yourself! Stop procedure for systemic reaction Check vital signs, oxygen saturation, ensure oxygen flow Rule out hypoglycemia Talk to patient and give reassurance (help alleviate anxiety and assist physician in evaluating symptoms) Note time of reaction, symptoms, treatment given ASDIN 5 Clinical Diagnosis Management Urticaria Observe, mark areas involved, supportive care, Diphenhydramine,, Adrenaline, admit Facial or Laryngeal Edema O mask 6- L/min, Diphenhydramine, Adrenaline, airway suction, code team, admit Nausea/Vomiting Diphenhydramine Bronchospasm (mild to severe) O mask 6- L/min, Nebulizer, adrenaline, admit Hypotension with bradycardia (Vagal Reaction) Elevate legs, O mask 6- L/min, IVF, atropine Generalized anaphylactoid reaction (severe bronchospasm, hypotension, laryngospasm, angioedema) Code team, Ox mask 6- L/min, airway suction, elevate legs, IVF, nebulizer, diphenhydramine, cimetidine, hydrocortisone, adrenaline 5

6 //5 Sedation/analgesia medication may result in respiratory depression High incidence of sleep apnea in patients (forced to lie on back for prolonged period + sedation) Fluid overload /pulmonary edema Mandatory continuous monitoring All patients should be on supplemental O for duration of procedure Grading of complications determined by O sat Therapy a. Change in O sat that requires nominal therapy & improves with supplemental O or patient positioning a. Prolonged (>sec) decrease in O sat (<9%) which improves with minor therapy. Use of non-rebreather mask. Reversal of sedation/analgesia therapy required a. Insertion of oral airway, IMA, or intubation b. Hospitalization observation or continued therapy Severe consequence a. Respiratory or cardiac arrest b. Permanent Impairment secondary to respiratory depression c. Death Drug-induced depression of consciousness Responds purposefully to verbal commands, either alone or accompanied by light tactile stimulation No interventions required to maintain patent airway spontaneous ventilation is usually maintained Conscious sedation Criterion Score Consciousness a. Awake or at baseline b. Responding to stimuli c. Not responding Expertise in airway management Pre-op history and physical Pre-op evaluation General Clinical Status Score American Society of Anesthesiologists Physical Exam Classification (ASA Class) Procedure fasting Class Airway a. Coughing on command or at baseline b. Maintaining good airway c. Airway requires assistance Oxygen Saturation a. 9% or greater, at baseline or greater b. 9% or greater on supplemental O c. Less than 9% on supplemental O Movement a. Movement purposeful or at baseline b. Nonpurposeful movement c. Not moving Ambulation a. Ambulate unassisted or at baseline b. Ambulate only with assistance c. Unable to ambulate Total Score ASDIN 5 I No systemic disturbance (i.e. healthy, no medical problems) II Mild to moderate systemic disturbance (i.e. HTN, diabetes) III Severe systemic disturbance (i.e. heart disease that limits activity) IV Severe systemic disturbance that is life-threatening (i.e. unstable angina, CHF) V Moribund and little chance of survival (i.e. ruptured abdominal aortic aneurysm) VI Declared brain dead and having procedure for organ donation 6

7 //5 Constantly present to monitor May assist with minor, interruptible tasks once level of sedation-analgesia & VS stable Monitor screen & able to observe patient face Knowledge of pharmacology of drugs and pharmacologic antagonists Level of consciousness Respiratory depression Hypoxemia Vital sign changes ECG changes Pain Have Immediately Available Airway equipment Fluid overload Suction Not taking oral antihypertensive meds Defibrillator Resuscitation medications Underlying cardiac function abnormalities Crash cart checks Electrolyte abnormalities Fluid overload Adverse reaction to conscious sedation medication Procedural blood loss Iatrogenic pulmonary embolism Wire placement Therapy a. A change in B/P which requires nominal therapy. change in patient position. change in IV infusion rate ASDIN 5 a. A change in B/P which requires minor therapy. Fluid bolus. B/P medication administration. Reversal of sedation/analgesia a. A change in B/P which does not improve with minor therapy b. Medication via IV drip infusion c. Hospitalization for observation or continued therapy Severe Consequence a. Cardiac resuscitation b. Permanent impairment of cognitive function c. Death 7

8 //5 Therapy a. Transient (<5 min) abnormal cardiac rhythm which resolves with nominal therapy. Supplemental oxygen. Correction of blood pressure alterations a. Prolonged (>5 min) abnormal cardiac rhythm which resolves with minor therapy. antiarrhythmic medication. Reversal of sedation/analgesia a. Sustained abnormal cardiac rhythm which does not resolve with minor therapy b. Administration of medication via continuous IV drip infusion c. Cardioversion d. Hospitalization for observation of continued therapy Severe Consequence a. Cardiac Resuscitation b. Death Evaluate prior to procedure to establish baseline Re-evaluate and score prior to discharge deterioration of GCS score a. Patient required prolonged observation but returned to baseline deterioration of GCS score a. Patient required minor therapy but returned to baseline deterioration of GCS score a. Patient did not return to baseline b. Required hospital admission Death initiated by initial deterioration of GCS score during the procedure ASDIN 5 8