Informed Consent Improving Resident Efficiency and Competency
Informed Consent Basics • At the root of any informed consent is understanding of the procedure, its intended benefit, complications and their likelihood, and alternatives to the procedure • The Handbook of Interventional Radiologic Procedures (Lippencott Williams & Wilkins) provides adequate explanation of any procedure you will be consenting for. • The following slides are aimed at preparing you for everything else
Why is this important? • 2003 study in Europe was the only study to examine patient and physician opinions on informed consent as of a Pubmed search of 11/2013 • 786 interventional radiologists (attending level) polled • Respondents were asked whether they felt patients received adequate explanation regarding indications for intervention, the procedure, alternative treatment options, and complications. (Junior medical staff obtained consent in 58% of cases) • Only 69% of respondents were satisfied with their level of explanation regarding indications for treatment • Only 79% felt that they adequately explained the procedure. • No formal studies on IR related informed consent are available in the United States literature. • No studies have been published that documented junior medical staffs comfort level of the procedure and consent for the procedure
The Dichotomy How we see it How the patient sees it
Components of Informed Consent • Disclosure • Informer must supply the subject with enough information to make an autonomous decision • Capacity • Patient must both understand the information provided and form a reasonable judgment based on the potential consequences of his/her decision. • Voluntariness • Patient has a right to freely exercise his/her decision making without being subjected to external pressure such as coercion, manipulation, or undue influence
Informed Consent 6 Components of a true informed consent: 1. The purpose and nature of the procedure or treatment. 2. The method by which the procedure or treatment will be performed. 3. The risks, complications, and expected benefits or effects of such procedure or treatment. 4. The risk of not accepting the procedure or treatment. 5. Any reasonable alternatives to the procedure or treatment and their most likely risks and benefits. 6. The right to refuse the procedure or treatment.
In Case of Emergency… Here are the rules: 1. When any delay in treatment would jeopardize the health of a patient, and the patient is unable to give informed consent, the physician can imply consent. 2. If the patient is unable to consent and has a legally authorized representative who is available to consent, the treating physician must obtain the informed consent of the representative. 3. When informed consent cannot be obtained from the patient or from his or her legally authorized representative, the physician treating the patient should determine the immediacy of the need for treatment. • a. A physician may provide any treatment or perform any procedure immediately required to prevent serious disability or death or to alleviate great pain and suffering. • b.During the course of an operation or a procedure, a physician may perform any procedure that becomes necessary because of a condition discovered or arising during the operation or the procedure that presents an immediate threat to the life or the health of the patient. 4. Even if emergent, if patient is competent, they can deny a life saving procedure.
“Pain, Bleeding, Infection…” • Procedures vary greatly in complexity and associated complications. • Complications are unique to each procedure. • This is what we do, just to name a few : Needle Biopsy of the Thyroid Paracentesis and Thoracentesis Percutaneous Abscess Drainage Percutaneous Gastrostomy Radiofrequency Ablation of Tumors Transjugular Intrahepatic Portosystemic Shunt (TIPS) Uterine Fibroid Embolization Varicocele Embolization Vascular Access Procedures Vertebroplasty & Kyphoplasty Vascular Malformation Sclerotherapy Carotid Angiogram Chest Port Inferior Vena Cava Filter Liver Transarterial Chemoembolization Percutaneous Abdominal or Pelvic Drain Percutaneous Dialysis Fistula Graft Radiofrequency Ablation Uterine Fibroid Embolization Vertebroplasty and Kyphoplasty Yttrium-90 Radiotherapy Angioplasty and Vascular Stenting Aortic stent graft placement Biliary Interventions Catheter Angiography Catheter Embolization Catheter-directed Thrombolysis Chemoembolization Chest tube placement Chest port placement Dialysis access Dialysis and Fistula/Graft Declotting and Interventions Inferior Vena Cava Filter Placement and Removal Needle Biopsy under CT and Ultrasound guidance Renal Angiogram Tunneled Central Venous Catheter Transjugular Intraheptic Portosystemic Shunt Procedure Transjugular Liver Biopsy
Indications for Placement • Monitoring of the central venous pressure (CVP) in acutely ill patients to quantify fluid balance • Long-term Intravenous antibiotics • Long-term Parenteral nutrition especially in chronically ill patients • Long-term pain medications • Chemotherapy • Drugs that are prone to cause phlebitis in peripheral veins • KCl; Vasopressors; Amiodarone • Plasmapheresis • Peripheral blood stem cell collections (Trifusion) • Dialysis (Hickman) • Frequent blood draws • Frequent or persistent requirement for intravenous access • Need for intravenous therapy when peripheral venous access is impossible (rare)
Central Lines: Potential Complications (Jugular access) • Pneumothorax – range from 0.1-1% (more in SCV placement) • Delayed PTX – 0.5% of all pneumothoraces (>6h after placement) • Malposition – usually not an issue with image guided placements • Cardiac arrythmia – up to 25% - Usually resolves with withdrawl of wire but can cause malignant arrythmia. • Guidewire loss • Catheter related thrombosis • Air embolism • Venous Perforation • Inability to place catheter • Others include Chylothorax (LIJV), lympohocutaneous fistula, • Vascular injury (Carotid puncture) – 1-6%. Use of ultrasound aids inadvertent arterial puncture. • Up to 40% of Carotid punctures are associated with hematoma formation. Other complications include stroke, AVF, psuedoaneurysm formation • Death Postrprocedure : thrombosis, venous stenosis, infection, catheter fracture, air embolism on extraction
Central Lines – Complication factors • Inexperience, variably defined but with a consistent relationship between less experience and the rate of complications. 2. Number of needle passes, with the incidence of complications rising with two venopunctures • Body mass index, previous catheterizations, and severe dehydration or hypovolemia are factors that increase risk. 4. Coagulopathies do not appear to increase the risk of percutaneous insertion, if appropriate measures are taken to attempt correction of coagulopathy. 5. Large catheter size 6. Unsuccessful insertion attempts is the strongest predictor of complication. • Overall, 5-19% reported incidence of complications in ICU patients – much less in IR.
Indications • Diagnostic • New onset ascites • Suspected spontaneous or secondary SBP Including : • Fever • Leukocytosis • Vomiting • Abdominal tenderness • Paralytic ileus • New hospitalization or ER visit • Hepatic Encephalopathy • Renal Failure (new onset) • Worsening liver function • Therapeutic • Respiratory compromise • Abdominal pain or pressure
Paracentesis Complications • Post paracentesis hypotension (73% if 5-8L) • Bacterial peritonitis (<1%) • Hemoperitoneum (<1%) • Abdominal wall hematoma (<1%) • Site infection • Ascitic leakage • Hyponatremia • Death
Paracentesis in thrombcytopenia • JVIR article Apr 2013 • 304 Paras completed by Attendings and juniors • Platelets <50k (mean 38k): INR avg 1.6 • <1% major bleeding complication (Req Transfusion) **Bleeding complication risk is extremely low, unless organ or arterial injury occurs. ** • NEJM does not recommend platelet or FFP transfusion preprocedure.
Hepatology: Albumin reduced post paracentesis circulatory dysfunction (PCD) events by 66% in patients with 5-8L removed. Above graph shows it superior to various other alternative treatments • Albumin reduced hyponatremia events by 42% when compared with no treatment • Reduced Death rates by 36%
Indications Diagnostic: • All new effusions Therapeutic: • Respiratory distress Contraindications • Chest wall cellulitis • Severe Coagulopathy • Severe lung disease (Pneumothorax risk) • Mechanical Ventilation (Decreased resealing)
Thoracentesis Complications Major Complications: • Pneumothorax (3-30%) • Hemopneumothorax • Hemorrhage (0.2%) • Hypotension (vasovagal response) (0.6%) • Reexpansion pulmonary edema ().5% when >1L removed • Death • Minor Complications: • - Dry tap (no fluid return) • - Subcutaneous hematoma or seroma (0.2%) • - Anxiety • Pain • Shortness of breath (1%) • Cough (0.8%)
Decision tree – Assesment of Filter placement, choice of filter, method of placement
Indications and ACR guidelines – Filter placement • Inferior vena cava filter placement is most commonly indicated for deep venous thrombosis (DVT) or pulmonary embolism when anticoagulation therapy is contraindicated. Other indications detailed in chart on prior slide • Per the ACR Appropriate Criteria guidelines, free floating ileofemoral DVT is the only “usually appropriate” indication besides contraindication to anticoagulation and documented PE. • Almost all other indications are considered “may be appropriate” per ACR.
IVC Filter Placement Complications • Venous Access site (<1%) – • Bleeding • Hematoma • Infection • AVF • Thrombosis • PE despite filter placement – • 5.6% lifetime risk; Fatal in 3.7% • IVC thrombosis – 2.7% • incidence varies by filter, but this can cause critical phlegmasia and preclude removal. Filters decrease the risk of PE, but increase the risk of DVT. De novo DVT rates approach 14% after filter placement.
Filter Malposition • Highly variable • Due to operator experience • Minor malposition • crossed filter legs or filter tilt (which decreases the efficacy of the filter) • Major malposition : • Malposition in the IVC (suprarenal) • Deployment into a nonintended vein (dilated lumbar) • Filter migration. • This can happen in the acute phase of deployment or can happen as the result of delayed migration. • Patients must be aware, that despite rare, this can require major surgical intervention to fix.
Retrieval complications • Not all filters can be retrieved safely/successfully • IVC perforation by filter legs is common, • Incidence ranging from 40-95%. • Aortic, ureteral, lumbar arterial, frank IVC rupture, duodenal perforation can occur as a result of perforation . Frank IVC tear on retrieval can occur if the legs transgress the IVC • Fractured struts are common, fractured baskets are uncommon (fortunately). Fractures struts are rarely of clinical significance, and can be left in place in the absence of problems. • Device infection is luckily an extremely rare complication. • In select case reports, cultures from the device itself have turned up negative. Tissue or clot debris in the filter have been the culprits in select cases. • Death
Postprocedure management Always schedule patient for retrieval IVC filter removal under anticoagulation is appropriate If you fail, Try Harder.
Indications Patients with diffuse liver disease requiring biopsy with 1 or more of the following conditions: • Deranged coagulation • Massive ascites • Liver abnormalities such as peliosis hepatitis • In combination with transjugular intrahepatic portosystemic shunt (TIPS) or venography • Any other contraindication for percutaneous biopsy • Failed percutaneous biopsy • Morbid obesity • Soft indication for pressure measurement to determine functional portal hypertension
Complications • The complications are access site - related and cardiac or hepatic complications. • Liver capsule puncture • Liver hematoma • Hematobilia • Cardiac arrythmia • Portal vein – Arterial/Bilious fistula • Psuedoaneurysm • Renal failure/Contrast reaction • All vascular access complications. • Death • The reported total complication rate is 7.1%. ( 1.3-20.2% depending on the source) • Mortality rates of 0.09% (adults) and 0.1% (children) have also been reported. • Mortality is due to hemorrhage from the liver or ventricular arrhythmia. Other complications included neck pain, hematoma in the neck, carotid artery puncture, pneumothorax
Common Patient Questions How common are nondiagnostic biopsies? • A technical success rate of 96.8% has been reported in a recent meta-analysis that included more than 7500 cases. (3.2% conversion rate) • Inability to catheterize the RHV was the most common reason (43.3%) for failure. • Fragmentation rates vary between 10-24% • Diagnostic sample rates vary between 2-10% How long will the procedure take? • Average fluoroscopy time : 4 min • The mean duration of the procedure is 40 min • Radiation dose ranges from 0.5 - 1 mSv. How often is conversion to percutaneous biopsy required?
Percutaneous Gastrostomy Willis Oglesby (WOG) tube
Indications • Dysphagia due to neurological disorder • Head and neck malignancies requiring surgical therapy or radiation that may inhibit access to nutrition • Chronic disease states where the patient cannot fill caloric requirements by oral intake alone • Intestinal disorders requiring special formula for feeding • Palliative for gastric outlet obstruction or small bowel tumor
Why we do it, not GI • Percutaneous radiological gastrostomy (PRG) has a success rate comparable to that of the Surgical/endoscopic method, with lower morbidity and mortality rates. • PRG has a success rate at 99.2%, PEG (95.7%), Surgical (100%) • Total and major complication rates Surgery (29% and 19.9%, respectively); PEG (15.4% and 9.4%); and PRG (13.3% and 5.9%) • May be performed in patients for whom the endoscopic method would be difficult or dangerous, such as those with head and neck malignancies (can avoid potential complications with endo as well as the low associated tumor seeding rate) We’re not always perfect …
Contraindications Absolute • Uncorrected coagulopathy remains an absolute contraindication due to the possibility of uncontrollable internal hemorrhage. • Preprocedure screening should be performed, and coagulopathy corrected • Suggested acceptable parameters include an International Normalized Ratio (INR) of 1.3 or less and a platelet count of at least 80 × 109/L. • If possible, this procedure should also be avoided in patients with portal hypertension and varices due to the potential for massive hemorrhage. Relative • Many patients requiring gastrostomy placement are immunosuppressed, either due to their underlying illness or to the use of medications such as steroids. • Immunosuppression is associated with higher rates of pericatheter leakage,and this should be considered in preprocedure assesment/consent. • Interposition of either colon or liver between the stomach and anterior abdominal wall • Previous major gastric surgery • Ascites (if controllable through drainage or diuretics PRG can be considered.)
To pexy or not to pexy… Against: - Thorton et al (2002) showed no difference in mortality, (N=48) - Incidence of discomfort or erosion of T-Tacs has been reported, and discomfort can approach 20%. - Additional gastric punctures may be associated with a higher risk of hemorrhage. -Potential for T-fasteners to cause skin ischemia and pressure necrosis -Gastropexy adds complexity and time, and as a result, cost, to the procedure. Support: - Reduces the risk of initial peritoneal catheterization - Pericatheter gastric leakage - Later intraperitoneal tube migration Also: - Replacement of dislodged tubes is easier, leading to lower rates of repeat gastrostomy (formation of adhesions maintains alignment and allows the mucocutaneous tract to mature earlier) • Animal studies have shown that when gastropexy is used, adhesion between the stomach and abdominal wall occurs as early as 24 hours after the procedure. • (It may also make the primary placement of larger tubes, which are believed to have lower occlusion rates, easier, and by acting as a tamponade, may decrease the risk of early gastric hemorrhage)
Complications Major complications: • Peritonitis • Septicemia • Significant stomal infection • Aspiration • Hemorrhage • Gastrointestinal perforation • Dislodgment of tube requiring repeat procedure or surgery • Minor complications: • low-grade pericatheter leakage • superficial stomal infection • tube dislodgment not requiring repeat procedure • tube occlusion • tube or balloon rupture
Common Gastrostomy Tube Management Questions: A reference How do I clean the tube site? - Soap and water are recommended. Avoid hydrogen peroxide or alcohol as they may irritate the skin or inhibit healing. -Antibiotic creams are generally not recommended as they increase skin maceration I’m getting nauseated with feeds, what do I do? - Gently pull back on the tube to ensure that it is sealed against the stomach wall, and not causing an outlet obstruction - Check the measurement to ensure that the tube is not post pyloric - Consider slowing the rate, (confirm with nutritionist) - If patient has a GJ tube – this may indicate significant underlying problem and the tube should be evaluated by fluoroscopy. My tube looks infected… What do I do? - Antibiotic creams can be considered, but not for >5days - Determine nature of infection (purulent vs Candida) – Treat accordingly - Warmed sterile saline and sterile gauze can be used as a compress TID if bacterial infection is suspected. - If symptoms persist, schedule an appointment to be seen by a doctor.
Common Gastrostomy Tube Management Questions: A reference (cont’d) My tube is leaking… What do I do? - Upsizing the tube will usually only upsize the tract, and is not generally recommended - Check for residuals – you may be filling up a stomach that isn't emptying. - Pull back gently on the tube to ensure it is snug to the stomach wall - Tube may be cracked internally – consider fluoroscopic evaluation - Check balloon to ensure that it is not deflated - Barrier cream can be used to prevent skin breakdown - PPIs can be considered to decrease acidity of leaked contents, Motility agents can be considered to promote outflow and decrease pressure My tube is clogging/is clogged … what do I do - Warm the tube prior to administering meds by indwelling warm water - Do not crush enteric meds and put them in the tube - Fill the tube with 1-3ml of carbonated water, dwell for 5 minutes, gently massage tube, then attempt to flush and aspirate - Pancreatic enzymes can be used if the patient is in house. My tube just fell out … what do I do? - If the tract is immature (<6weeks) – go to the ER to be evaluated - If the tract is matured, a Foley can be placed that is 1fr size smaller than the initial G tube. Formal nonemergent replacement should be scheduled
Contraindictations • Absolute • None • Relative • Uncorrectable bleeding diathesis or coagulopathy • Terminally ill patient to which no quality of life benefit is expected (tube management is difficult) • Pregnancy (radiation risk)
Success rates • Success rates generally vary by clinical scenario and operator, however here are the broadly generalized success rates by scenerio and threshold to maintain certification:
Common tube management questions 1. When do I empty/change the bag? - Empty the bag before it is completely full. - Changing the bag is recommended only if there is leak or malfunction. The bag can also be changed for cosmetic reasons. 2. Can I bathe or swim? • Never submerge the tube. Sponge baths are recommended to keep the dressing dry. 3. Can I shower? • You can take a shower if you put a plastic covering, such as Saran Wrap, over the area. 4. When do I change the dressing? - The dressing (gause) should be changed every 3 days or when it gets soiled, wet, or loose. • Tegaderm should only be changed once a week or when it becomes soiled, wet, or loose.
Indications and Complications Indications Contraindications • Complications vary highly by location and organ • Contraindications: Always be sure that the biopsy will change management in some way.
Success and Complication Rates Globally, you can quote to patients a 70-90% success rate for any percutaneous biopsy (excluding those not safely accessable) Hypervascular organs (kidney/spleen) have 05.-2% “significant” bleeding rate with our traditional 19ga Temnos Always consent for tract seeding