Introduction
Methods
Literature Search
Study Selection, Outcome and Covariate Definitions
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Study design: prospective or retrospective human cohort studies including randomized control trials (RCTs).
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Population: pediatric (infant to 18 years) and/or adult (≥ 18 years) patients with diffuse liver disease, including post-transplant and up to 25% focal disease.
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Exposure: any percutaneous liver biopsy (including US-guided, US-assisted, CT-guided, percussion-guided or plugged).
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Outcomes: within 3-months from biopsy, clearly reported counts for hospitalization, major and minor complications and technical failure.
Data Extraction and Risk of Bias Assessment
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Low risk of bias: describes studies for which all domains had no risk;
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Moderate risk of bias: describes studies for which one or more domains are scored as “partial” or one domain is scored as “yes risk of bias”;
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High risk of bias: describes studies for which more than one domain is scored as “yes risk of bias.”
Statistical Analysis
Results
Study Selection and Quality Assessment
Study and Cohort Characteristics
Author (year), Country | Study design Time period Sampling framea | Population diagnosisb | Population demographicsc | Biopsy type | Confounders: Coagulation criteria Procedural sedation Experience | Outcomes reported | Follow-up details |
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Atar (2010), Israel; Single center [38] | Retrospective review; 2000–2006; Consecutive patients | PLP: Pediatric ascites 9.9%, liver cirrhosis 6.1%, and liver transplants 53.7% | PLP: mean age 46 years (10 years, 79 years); 11% pediatric; 59% male | Transjugular (TJLB) or plugged-percutaneous (PLP) | PLB: platelets 60,000- 100,000/mL- or INR 1.4–2, or pediatric ascites. Local anesthesia in adults but sedation in pediatric. Experienced interventional radiologist | AE, deaths, SAE | At hospital 12 h or 24 h and discharged if no symptoms. Discharge information and 2-week biopsy result consultation. [spontaneous] |
Basu (2012), USA; Single center [21] | Randomized, prospective blinded; Not reported | Chronic liver disease with thrombocytopenia. Viral: 72.5%; Alcoholic Cirrhosis: 15%; NASH: 5%; PBC: 9%. Mode fibrosis F4 | Mean age 56 years; 66.7% male | Percutaneous | Mean platelets 70,000/mL; Mean MELD score 20; Sedation and experience not reported | Hematoma only; meticulous side-effects of each treatment group | 4 week post-biopsy [spontaneous] |
Costa (2019), Portugal; Single center [29] | Prospective RCT; 2014–2017; Randomly selected | Persistent liver abnormalities 23.3%; NAFLD 28.9%; Viral 24.4%, AILD 15.7%; Metabolic 4.4%; Other 3.3% | Mean age 50 years; 54% male | Percutaneous preceded by US exam | Included: platelet count over 50,000/μL, INR < 1.5. Antiplatelet (clopidogrel/ticlopidine) and anticoagulant agents were suspended or reverted. Conscious sedation (midazolam and meperidine 25 mg) and local anesthetic medication (5 ml of 1% lidocaine). Randomized for 3 recovery positions. Experience not reported | AE, deaths, SAE | 4 h observation period for solicited adverse events. Electronic record evaluation 7 days post-biopsy. [solicited] |
El-Shabrawi (2012), Egypt; Single center [28] | Prospective; Not recorded; Not recorded | 95% hepatomegaly, 40% splenomegaly, 20% jaundice | 20% < 1 years; 60% 1–6 years; 20% 6–14 years . Male/female not reported | Blind, US-assisted, percutaneous | Included: patients with PT < 3 s with/without correction by vitamin K and platelets > 70,000/μL. Sedation in 85% of patients; local anesthesia in 100% of patients. Experience not reported | AE, deaths, SAE | Vital signs recorded hourly for the first 4 h, two hourly for the following 4 h and then at 24 h after the procedure. US at 24 h post-procedure. In those with irritability or pain, CXR rule out the possibility of small pneumothorax. [solicited] |
Filingeri (2016), Italy; Single center [39] | Retrospective; 2004–2014; Not reported | 64% orthotopic liver transplants (OLT). Remaining 36%: 82.8% viral; 13.5% ASH; 2.4% NASH; 1.1% AIH; 0.8% biliary; 0.3% metastasis | Mean age 42–52 years; 70% male | Percussion-guided percutaneous (4.9% with US-guidance) | Included: platelet count over 40,000/μL, INR < 2, Hgb .8.0 g/dL. Anticoagulants discontinued 3 days before biopsy. Local anesthesia (Rovicavaine). Experience not reported | AE, deaths, SAE | Monitoring for 4–6 h then discharge in the absence of complications. [spontaneous] |
Hall (2017), UK; Single center [40] | Retrospective review; 2014–2016; Selected based on availability of histology data | Focal disease excluded. Non-alcoholic and alcoholic liver disease, viral hepatitis, autoimmune hepatitis, cholangiopathy and metabolic/genetic factors including hemochromatosis | Median age 43 years; 52% male | Percutaneous | Coagulation criteria and sedation not reported. Experienced interventional consultant radiologists | AE, deaths, SAE | Rebiopsy/diagnosis within 3 months. Separate audit to record pain or vasovagal episodes within 2 h of biopsy for 36% biopsies. [spontaneous] |
Hu (2010), Taiwan; Single center [41] | Prospective, randomized; 2006–2009; Not reported | No focal disease | Not reported | Percutaneous, Tru-cut biopsy (TCB) or co-axial biopsy (CAB) | Platelets > 50*10^9/L. Sedation and experience not reported | Bleeding, pain, deaths | US and pain score at 24 h post-biopsy. [solicited] |
Kim (2017), Korea; Single center [42] | Retrospective; 2007–2013; Consecutive patients | Suspected rejection of living donor liver transplants | 50 years (range 4–68 years); 78% male | Plugged percutaneous with US-guidance | INR < 2 with vitamin K administration, some biopsies proceeded with caution despite being out of range, using N-butyl cyanoacrylate. Sedation not reported. Interventional radiologists with more than 12 years of experience | AE, deaths, SAE | Observation for 1 h and imaging not routinely performed without clinical signs. Medical record review. [spontaneous] |
Mogahed (2016), Egypt; Single center [43] | RCT; 2013; Scheduled cases | 36.4% neonatal hepatitis 36.4%, 26.3% biliary atresia, 21.2% chronic hepatitis, 4.04% glycogen storage disease;, 4.04% paucity of intralobular bile ducts, 2.02% congenital hepatic fibrosis | Median age 2.5 months (range 18 days–12 years). 61% male | Percussion-guided percutaneous with/without US-assistance | Prothrombin time within 3 s, platelet > 80,000/μL, Hgb > 7 g/dL. Sedation on all patients (midazolam or ketamine). Experience not reported | AE, deaths, SAE | Assessment of at 30 min, 60 min, 90 min, 2 h, 3 h, 4 h and 6 h post-procedure. US at 6 and 48 h. [solicited] |
Mueller (2012), Germany; Single center [25] | Prospective; 1999–2009; Not reported | Viral 30%; Autoimmune 3.8%, 0.04% transplants; 10% HCC; 56.5% NASH | Mean age 53 years; 45% male | US-guided or assisted percutaneous (fine needle aspiration cytology, 0.3%, or cutting biopsy, 28.9%, or aspiration with Menghini, 70.8%) | Included: platelets ≥ 70,000/μl, Quick’s test value ≥ 70%, PTT < 50 s; some deviations reported. No use of anti-coagulants. Sedation not reported. 39% performed by experienced (> 150 liver biopsies) and 61% by inexperienced clinicians | AE, deaths, SAE | Monitored for 4 h with US for all but fine needle aspiration cytology. [solicited] |
Procopet (2012), Romania; Single center [44] | Prospective not randomized; Undefined 6-month period; Not reported | PLB: Cirrhosis 12%, 16% ASH; 21.3% viral; 62.7% others | PLB: Mean age 53 years; 39% male | Transjugular (TJLB) and percutaneous preceded by US exam (PLB) | Hemodynamic criteria not defined. Local anesthesia for all biopsies. 88% performed by experienced (> 150 liver biopsies) or 12% by inexperienced clinicians | AE, deaths, SAE. Only pain specified from minor complications, though all reported | After the procedure, patients were monitored for an additional 2 h. Anxiety assessed 1 day before and 1 day after procedure. [solicited] |
Sagnelli (2012), Italy; 15 hepatology centers [24] | Prospective; 2005; Not reported | 84.4% Viral; 16.6% other chronic liver disease | Mean age 48 years; 62% males; Mean BMI 22 kg/m2 | US-guided or assisted percutaneous | Included: ≥ 75,000 mm3 for platelets, ≥ 50% Prothrombin. No sedation data recorded. Clinicians with more than 500 liver biopsies in the previous 10 years | AE, deaths, SAE | Medical records within 4 days. [spontaneous] |
Sandrasegaran (2016), USA; Single center [45] | Retrospective review; 2008–2014; all complete database records | 35.9% viral; 25% NASH; 13.4% ASH; 34.5% other non-focal disease | Mean age 51 years (range 14–85 years); 50% male | Percutaneous | Mean INR 1.33–1.5 and platelets 156–209*10^9/L suggest few patients with severe coagulopathy. Sedation and experience not reported | Death and specific major bleeding events (acute hemoperitoneum, drop in hematocrit requiring transfusion or embolization) | Electronic medical records for the period of 2 weeks prior to biopsy to 4 weeks after biopsy. Also records from 1 month-post biopsy clinic. [spontaneous] |
Seeff (2010), USA; 10 hepatology centers [46] | Retrospective; 2000–2006; | Compensated chronic hepatitis C and nonresponse to prior treatment with interferon with or without ribavirin. 39.9% cirrhosis; 41.0% varices | Mean age 52 years; 72% male; Mean BMI 30 kg/m2 | Percutaneous | Included: platelet counts ≥ 50,000/mm3. Mean INR 1.1. No NSAID or aspirin 7 days before biopsy. All with local anesthesia. 60% had conscious sedation with short-acting benzodiazepines. Hepatologists, with 20% biopsies performed by supervised gastroenterology or hepatology fellows | AE, deaths, SAE | Same day discharge with close monitoring in 20%. Clinic within 3 months of biopsy. Medical record review for complications within 30-days of biopsy. [spontaneous] |
West (2010), UK; Multi-center [47] | Retrospective review; 1998–2005; Not reported | 16.9% abnormal LFT; 56.6% liver disease; 26.4% other (not cancer) | 18 years or older. Age/gender not reported clearly | Elective, first, percutaneous liver biopsy | Not reported | Major bleeding, deaths | Medical record review of procedure codes occurring within 7 days of biopsy. [spontaneous] |
Atwell (2010), USA; Single center [48] | Retrospective review; 2002–2008 | Only parenchymal disease, included both transplants and native livers but numbers not reported | Mean age 56 years (range 15d to 96 years with 18 years SD); 55% Male | US-guided percutaneous | Included: platelet count over 50*10^9/L, international normalized ratio (INR) < 1.6. Minority of patients had taken Plavix prebiopsy. Aspirin not excluded. Sedation and experience not reported | Only grade 3 hemorrhage (an event for which a transfusion, an interventional radiology procedure, or an operative intervention is indicated) & deaths. [NCI, 2006] | Phone call at 1, 2 or 3 days after biopsy and second review at 3 months for delayed complications. [solicited] |
Bilreiro (2017), Portugal; Single center [49] | Retrospective review; 2011–2016; Consecutive patients | 55.7% transplants; Native liver indications: 25.7% elevated LFT; 5.9% focal; 5.9% Wilson's; 13.9% AIH; 9% Viral; Metabolic: 5.9%; Other 33% | Median age 9 years (range 1 months–18 years); 53% male | US-guided percutaneous | Included: platelet count over 50,000/μL, international normalized ratio (INR) < 1.5. Several procedures were, however, performed in patients with higher INR and lower platelet counts (lowest platelet count: 29 G/L; highest INR: 1.7). 98% general anesthesia; 2% local anesthesia. Experience not reported | AE, deaths, SAE | Monitored for at least 6 h after the procedure, including assessment every 30 min for hemodynamic status. In cases of symptoms, or an immediate identified complication, a control ultrasound evaluation was performed after the first 6 h and monitoring extended for 12 to 24 h. [solicited] |
Farrington (2012), UK; Single center [27] | Prospective research trial; 2004–2010; Not reported | NAFLD/NASH (40%), HCV (26%), AIH/PSC/PBC (14%), ALD (14%). 14.5% patients had established cirrhosis | Mean age 51 years; 56.9% male | US-guided percutaneous | Included: platelet count > 80,000/μL and INR < 1.3. Local anesthetic (lidocaine). Performance of 45 biopsies under direct supervision before independent performance, in presence of consultant radiologist | AE, deaths, SAE | Not reported: immediate and overnight effects described. [spontaneous] |
Mahadeva (2015), Malaysia; Single center [26] | Prospective trial; 2009–2010; Consecutive patients | 77.1% NAFLD; Viral 22.0% | Mean age 50 years; 56% male; Median BMI 28 kg/m2 | US-guided percutaneous | Included if platelets > 150*10^9/L. Local anesthesia (lignocaine). Performed ∼50 biopsies before this study | AE, deaths, SAE | Monitored at 6 h for signs of pain or bleeding. 1 week follow-up phone call. Follow-up clinic 2 week post-biopsy. [solicited] |
Matos (2012), Portugal; Single center [50] | Retrospective study; 1999–2010; | 73.9% orthotopic liver transplant; 22.8% suspected chronic liver diseases [biliary atresia (42.7%), metabolic diseases (20.5%), alpha1-antitrypsin deficiency (14.5%), acute liver failure (10.3%), viral hepatitis (4.3%), autoimmune (4.3%), other causes (3.4%)]; 3.3%) focal lesions | Mean age 8 years (1 months–17 years) | US-guided percutaneous | Included: INR < 1.5 and platelet count > 50*10^9/L.7.2% received transfusion/plasma/rFactor VII to optimize coagulation profile. General anesthesia. Experience not reported | AE, deaths, SAE | Monitored at 6 h for signs of pain or bleeding. Followed up with US and extended observation to 24 h if clinical signs. [solicited] |
Nodarse-Perez (2016), Cuba; Single center [51] | RCT; 2011–2012; Not reported | Elevated LFT (31%), Viral (28%), Cholestasis (8%), Metastasis (8%) | Mean age 48–50 years; 44% male | US-guided percutaneous | Included: platelets ≥ 70,000, Quick’s test value ≥ 50%. Hgb l > 8 g/dL. Local anesthesia (lidocaine 2%). Experience not reported | AE, deaths, SAE | Monitored for 1–4 h, with 24 h follow-up phone call. [solicited] |
Pan (2015), New Zealand, Single center [52] | RCT; 2009–2011; Consecutive patients | 61.2% Viral; 39% other (non-focal) | Mean age 42–52 years; 70% male; Mean BMI 28 kg/m2 | US-guided, percussion-assisted percutaneous | Included: INR < 1.5 and platelet count > 50*10^9/L. Local anesthesia (1% xylocaine containing 1:100,000 adrenaline). All patients metoclopramide: placebo with saline vs with pethidine. Performed both by the consultant and advanced trainee in gastroenterology | AE, deaths, SAE | Monitored for 4 h with additional pain evaluations. Followed up with phone call at 24 h. [solicited] |
Sezgin (2017), Turkey; Single center [23] | Prospective; 2017; Consecutive patients | Chronic disease details not reported | Mean age 42 years; 70% male | US-guided percutaneous | Not reported | AE, deaths, SAE | Patient questionnaire 2 h before biopsy and monitoring for 4 h before hospital discharge. 24 h assessment with US and patient questionnaire. [solicited] |
Short (2013), USA; Single center [36] | Retrospective; 2008–2011; All patients with inclusion criteria | 31% transplant; 8% portal hypertension; 11.7% malignancy | Median age 7 years (1 week–22 years); 51% males | US-guided or CT-guided percutaneous | Included: median INR of 1.1 (range 0.9–3.5). 97.2% had an INR. Sedation and experience not reported | SAE, deaths | Follow-up until 96 h post-biopsy or time of discharge. [spontaneous] |
Sornsakrin (2010), Germany; Single center [53] | Retrospective; 2005–2008; Consecutive patients | 100% transplants. 41.8% biliary atresia; 10.4% acute liver failure, 10.4% Alagille syndrome, 9.0% cholestasis, 6.0% cirrhosis, 3.0% AIH, 3.0% PSC | Median age 8 years (range 6 months–18 years); 50% male | US-guided percutaneous | Normal plasma coagulation. Sedation with midazolam or ketamine. Experienced pediatric radiologist | AE, deaths, SAE | Monitoring for 2 h. Follow-up at 24 h. [solicited] |
Tublin (2018), USA; Single center [22] | Prospective; 2013–2014; Sequentially randomized | 32% transplants; 42% viral; 6.0% NASH; 5.3% AIH; 2.7% PBC | Mean age 54 years; 24% male | US-guided percutaneous | Corrected INR ≤ 1.5 and platelet count > 50 × 10^9/L. Local anesthesia (2% lidocaine). Imaging physician assistants with 2 and 14 years of intervention experience in tandem with abdominal imaging fellows or attending radiologists | AE, deaths, SAE | Monitoring for 4 h or until discharge. Follow-up call at 24 h. [solicited] |
Vijayaraghavan (2015), USA; Single center [54] | Retrospective; 2007–2010; Not reported | 61% viral; 10% elevated LFT, 6% NASH, 6% cirrhosis, 4% transplants | Age range 19–81 years. 64% male | US-guided percutaneous | INR ≤ 1.5 and platelet count > 50*10^9/L within 30 days pre-biopsy. Conscious sedation (midazolam and fentanyl). Radiologists, all of whom were either fellowship trained in abdominal imaging and intervention or had at least 10 years of experience | AE, deaths, SAE | Monitoring for 4 h with further overnight observation if clinical signs or symptoms. Medical record review for events within 15 days of biopsy. [spontaneous] |
Westheim (2013), Norway; Single center [55] | Retrospective; 2000–2011; Consecutive patients | 36.7% transplants; 10% focal lesions 10%; 29% Abnormal LFT 29%; 13% cholestasis | Median age 5 years (range 22 days–18 years). Not reported | US-guided percutaneous | Included: platelets ≥ 70,000/μl, INR < = 1.7 with hemodynamic correction pre-biopsy. General and local anesthesia. Operators who had not performed pediatric liver biopsies previously were supervised by an experienced colleague during the first procedures | AE, deaths, SAE | Monitoring closely within 2 h and every 4 h overnight when US performed. [solicited] |
Major Complications
Event | Pooled incidence (95% CI) | I2 (%) | tau | Heterogeneity P value (LRT-test)a | Included studies | Total events/Total biopsies | By population ageb Total events/total biopsies |
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Major complications | |||||||
Biliary events | 0.00% (0.00, 0.79) | 81 | 2.69 | 0.7079 | 27 | 4/9341 | A: 0/7443; M: 0/306; P: 4/1682 |
Death | 0.01% (0.00, 0.11) | 76 | 2.06 | 0.5157 | 29 | 12/64214 | A: 9/60390; M: 0/2142; P:3/1682 |
Hemobilia | 0.01% (0.00, 0.54) | 38 | 1.02 | 0.9997 | 25 | 3/8797 | A: 3/7137; M: 0/306; P: 0/1354 |
Sepsis | 0.02% (0.00, 0.51) | 24 | 0.77 | 0.9768 | 24 | 2/8608 | A; 1/7159; M: 0/306; P: 1/1143 |
Hemothorax | 0.03% (0.01, 0.10) | 0 | 0.00 | 0.9995 | 26 | 3/9125 | A: 2/7137; M: 0/306; P: 1/1682 |
Organ perforation | 0.03% (0.01, 0.10) | 0 | 0.00 | 0.9999 | 26 | 3/9013 | A: 2/7353; M: 0/306; P: 1/1354 |
Pneumothorax | 0.04% (0.02, 0.11) | 0 | 0.00 | 0.9999 | 27 | 4/9341 | A: 4/7353; M; 0/306; P: 0/1682 |
Hemoperitoneum | 0.06% (0.01, 0.39) | 84 | 2.05 | 0.0002 | 26 | 27/9125 | A: 15/7137; M: 0/306; P: 12/1682 |
Transfusion | 0.08% (0.02, 0.41) | 80 | 1.96 | < 0.0001 | 25 | 20/8057 | A: 7/6582; M 0/306; P: 13/1169 |
Major hematomac | 0.11% (0.02, 0.53) | 90 | 2.33 | < 0.0001 | 25 | 39/8797 | A: 14/7137; M: 0/306; P: 25/1354 |
Moderate/severe pain | 0.34% (0.08, 1.37) | 96 | 2.41 | < 0.0001 | 21 | 132/8346 | A: 112/7012; P: 20/1334 |
Major bleeding | 0.48% (0.22, 1.06) | 94 | 1.58 | < 0.0001 | 30 | 356/64356 | A: 293/60390; M: 14/2284; P: 49/1682 |
Hospitalization | 0.65% (0.38, 1.11) | 86 | 1.01 | < 0.0001 | 30 | 361/64356 | A: 318/60390; M: 14/2284; P: 29/1682 |
All major complications | 2.44% (0.85, 6.75) | 97 | 1.86 | < 0.0001 | 15 | 184/6013 | A: 153/5831; P: 31/182 |
Technical failure | 0.91% (0.27, 3.00) | 97 | 2.17 | < 0.0001 | 17 | 166/6801 | A: 90/4893; M: 5/306; P: 71/1602 |
Minor complications | |||||||
Vasovagal episodes | 0.15% (0.03, 0.66) | 89 | 2.28 | < 0.0001 | 23 | 34/7781 | A: 33/6432; M: 0/306; P: 1/1043 |
Other hematomad | 0.19% (0.03, 1.14) | 97 | 2.55 | < 0.0001 | 15 | 80/7177 | A: 10/5925; P: 70/1252 |
Other minor eventse | 0.27% (0.07, 1.03) | 94 | 2.51 | < 0.0001 | 23 | 65/8265 | A: 29/6277; M:1/306; P: 35/1682 |
Mild pain | 12.9% (5.34, 27.9) | 99 | 2.10 | 0.7079 | 19 | 704/7247 | A: 645/6241; P: 59/1006 |
All minor events | 9.53% (3.68, 22.5) | 99 | 1.69 | < 0.0001 | 11 | 424/6242 | A: 381/5649; P: 43/593 |
Minor Complications
Impact of Patient Age and Disease Severity on Complication Incidence
Event | P valuea | Original I2 (%) | Residual I2 (%)b | ||||||
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QM-test of covariates | Publication year | Population age | Disease severity | Outcome collection | Biopsy type | Residual heterogeneity (LRT-test) | |||
Hospitalization | < .0001 | < .0001 | <0.0001 | 0.0007 | 0.0033 | 0.0833 | 0.0004 | 86 | 0 |
Moderate/severe pain | 0.1555 | 0.1154 | 0.2451 | 0.3362 | 0.5547 | 0.0311 | < .0001 | 96 | 87 |
Major bleeding | < .0001 | 0.4799 | < .0001 | 0.5294 | 0.1175 | 0.0892 | < .0001 | 94 | 57 |
Transfusion | 0.0306 | 0.7782 | 0.0016 | 0.9402 | 0.9512 | 0.1267 | 0.0561 | 80 | 41 |
Major hematomac | 0.0780 | 0.2823 | 0.0191 | 0.7475 | 0.7131 | 0.2789 | < .0001 | 90 | 70 |
Other hematomad | 0.0177 | 0.7460 | 0.0586 | 0.8184 | 0.2373 | 0.6478 | < .0001 | 97 | 85 |
All major events | 0.2273 | 0.1469 | 0.2198 | 0.3229 | 0.4015 | 0.8049 | < .0001 | 97 | 88 |
Technical failure | < .0001 | < .0001 | 0.0015 | 0.0230 | < .0001 | 0.1278 | < .0001 | 97 | 58 |
Mild pain | 0.0002 | < .0001 | 0.7771 | 0.6829 | 0.7900 | 0.1901 | < .0001 | 99 | 96 |
Vasovagal episodes | 0.1625 | 0.3345 | 0.1185 | 0.6103 | 0.9617 | 0.2523 | < .0001 | 89 | 75 |
Other minor eventse | 0.0027 | 0.9610 | 0.0160 | 0.9305 | 0.0382 | 0.0207 | < .0001 | 94 | 77 |
All minor | < .0001 | 0.0002 | 0.0769 | 0.8692 | 0.1990 | 0.0613 | < .0001 | 99 | 90 |
Event | Odds estimate (95% CI) by covariatea | ||||
---|---|---|---|---|---|
Publication year | Population age | Disease severity | Outcome collection | Biopsy type | |
Hospitalization | 1.15 (1.08, 1.22) | 2.22 (1.62, 3.04) | 1.25 (1.10, 1.43) | 0.47 (0.28, 0.78) | 0.62 (0.36, 1.07) |
Moderate/severe pain | 1.47 (0.92, 2.35) | 0.42 (0.10, 1.83) | 2.01 (0.49, 8.24) | 0.51 (0.06, 4.80) | 11.5 (1.25, 105) |
Major bleeding | 1.07 (0.91, 1.25) | 4.00 (2.36, 6.77) | 0.85 (0.51, 1.43) | 0.48 (0.19, 1.21) | 0.48 (0.21, 1.13) |
Transfusion | 0.96 (0.68, 1.35) | 5.35 (1.89, 15.2) | 0.96 (0.33, 2.84) | 0.94 (0.12, 7.63) | 0.22 (0.04, 1.55) |
Major hematomab | 1.22 (0.86, 1.73) | 3.52 (1.23, 10.0) | 1.23 (0.36, 4.30) | 1.63 (0.13, 21.4) | 0.36 (0.06, 2.33) |
Other hematomac | 1.08 (0.69, 1.71) | 3.59 (0.96, 13.4) | 1.21 (0.25, 5.80) | 10.3 (0.22, 490) | 0.52 (0.04, 8.75) |
All major events | 1.31 (0.92, 1.88) | 2.15 (0.64, 7.23) | 1.93 (0.53, 7.02) | 3.71 (0.18, 78.9) | 0.75 (0.08, 7.78) |
Technical failure | 1.77 (1.43, 2.18) | 2.82 (1.49, 5.32) | 0.38 (0.16, 0.88) | 0.07 (0.03, 0.19) | 2.37 (0.79, 7.19) |
Mild pain | 1.78 (1.34, 2.37) | 0.89 (0.39, 2.04) | 1.22 (0.48, 3.12) | 1.29 (0.21, 8.10) | 2.51 (0.64, 9.86) |
Vasovagal episodes | 1.21 (0.83, 1.76) | 0.29 (0.06, 1.39) | 0.70 (0.18, 2.79) | 1.07 (0.09, 13.6) | 3.61 (0.41, 32.3) |
Other minor eventsd | 1.00 (0.74, 1.35) | 3.47 (1.27, 9.51) | 0.94 (0.21, 4.30) | 14.5 (1.16, 180) | 0.08 (0.01, 0.67) |
All minor | 1.97 (1.39, 2.80) | 2.2 (0.92, 5.23) | 0.95 (0.46, 1.93) | 0.37 (0.08, 1.72) | 3.43 (0.95, 12.5) |