[Determination of the 120-day post prostatic biopsy mortality rate]. / Mesure de la mortalité à 120 jours après biopsie de la prostate.

OBJECTIVE: Concerning death-rates were reported following prostate biopsy but the lack of contexts in which event occurred makes it difficult to take any position. Therefore, we aimed to determine the 120-day post-biopsy mortality rate. MATERIAL AND METHODS: Between 2000 and 2011, 8804 men underwent prostate biopsy in the hospice civils de Lyon. We studied retrospectively, the mortality rate after each of the 11,816 procedures. Biopsies imputability was assessed by examining all medical records. Dates of death were extracted from our local patient management database, which is updated trimestrially with death notifications from the French National Institute for Statistics and Economic Studies. RESULTS: In our study 42 deaths occurred within 120days after 11,816 prostate biopsies (0.36%). Of the 42 records: 9 were lost to follow-up, 3 had no identifiable cause of death, 28 had an intercurrent event ruling out prostate biopsy as a cause of death. Only 2 deaths could be linked to biopsy. CONCLUSIONS: We reported at most 2 deaths possibly related to prostate biopsy over 11,816 procedures (0.02%). We confirmed the fact that prostate biopsies can be lethal but this rare outcome should not be considered as an argument against prostate screening given the circumstances in which it occurs. LEVEL OF EVIDENCE: 5.

Outpatient versus inpatient observation after percutaneous native kidney biopsy: a cost minimization study.

BACKGROUND/AIMS: Percutaneous kidney biopsy (PKB) is the primary diagnostic tool for kidney disease. Outpatient 'day surgery' (ODS) following PKB in low-risk patients has previously been described as a safe alternative to inpatient observation (IO). This study aims to determine if ODS is less costly compared to IO while accounting for all institutional costs (IC) associated with post-PKB complications, including death. METHODS: A cost minimization study was performed using decision analysis methodology which models relative costs in relation to outcome probabilities yielding an optimum decision. The potential outcomes included major complications (bleeding requiring blood transfusion or advanced intervention), minor complications (bleeding or pain requiring additional observation), and death. Probabilities were obtained from the published literature and a base case was selected. IC were obtained for all complications from institutional activity-based cost estimates. The base case assumed a complication rate of 10% with major bleeding occurring in 2.5% of patients (for both arms) and death in 0.1 and 0.15% of IO and ODS patients, respectively. RESULTS: ODS costs USD 1,394 per biopsy compared to USD 1,800 for IO inclusive of all complications. IC for ODS remain less when overall complications <20%, major complications <5.5%, and IC per death

No excess mortality after prostate biopsy: results from the European Randomized Study of Screening for Prostate Cancer.

OBJECTIVE: • To assess possible excess mortality associated with prostate biopsy among screening participants of the European Randomized Study of Screening for Prostate Cancer (ERSPC). PATIENTS AND METHODS: • From three centres in the ERSPC (Finland, The Netherlands and Sweden) 50,194 screened men aged 50.2-78.4 years were prospectively followed. A cohort of 12,959 first-time screening-positive men (i.e. with biopsy indication) was compared with another cohort of 37,235 first-time screening-negative men. • Overall mortality rates (i.e. other cause than prostate cancer mortality) were calculated and the 120-day and 1-year cumulative mortality were calculated by the Kaplan-Meier method, with a log-rank test for statistical significance. • Incidence rate ratios (RR) and statistical significance were evaluated using Poisson regression analyses, adjusting for age, total PSA level, screening centre and whether a biopsy indication was present, or whether a biopsy was actually performed or not. RESULTS: • There was no statistically significant difference in cumulative 120-day other cause mortality between the two groups of men: 0.24% (95% CI, 0.17-0.34) for screening-positive men vs 0.24% (95% CI, 0.20-0.30) for screening-negative men (P= 0.96). This implied no excess mortality for screening-positive men. • Screening-positive men who were not biopsied (n= 1238) had a more than fourfold risk of other cause mortality during the first 120 days compared to screening-negative men: RR, 4.52 (95% CI, 2.63-7.74) (P < 0.001), adjusted for age, whereas men who were actually biopsied (n= 11,721) had half the risk: RR, 0.41 (95% CI, 0.23-0.73) (P= 0.002), adjusted for age. • Only 14/31 (45%) of the screening-positive men who died within 120 days were biopsied and none died as an obvious complication to the biopsy. CONCLUSION: • Prostate biopsy is not associated with excess mortality and fatal complications appear to be very rare.

Towards improving the safety and diagnostic yield of stereotactic biopsy in a single centre.

BACKGROUND: Previously, we reported on our single centre results regarding the diagnostic yield of stereotactic needle biopsies of brain lesions. The yield then (1996-2006) was 89.4%. In the present study, we review and evaluate our experience with intraoperative frozen-section histopathologic diagnosis on-demand in order to improve the diagnostic yield. METHODS: One hundred sixty-four consecutive frameless biopsy procedures in 160 patients (group 1, 2006-2010) were compared with the historic control group (group 2, n = 164 frameless biopsy procedures). Diagnostic yield, as well as demographics, morbidity and mortality, was compared. Statistical analysis was performed by Student's t, Mann-Whitney U, Chi-square test and backward logistic regression when appropriate. RESULTS: Demographics were comparable. In group 1, a non-diagnostic tissue specimen was obtained in 1.8%, compared to 11.0% in group 2 (p = 0.001). Also, both the operating time and the number of biopsies needed were decreased significantly. Procedure-related mortality decreased from 3.7% to 0.6% (p = 0.121). Multivariate analysis only proved operating time (odds ratio (OR), 1.012; 95% confidence interval (CI), 1.000-1.025; p = 0.043), a right-sided lesion (OR, 3.183; 95% CI, 1.217-8.322; p = 0.018) and on-demand intraoperative histology (OR, 0.175; 95% CI, 0.050-0.618; p = 0.007) important factors predicting non-diagnostic biopsies. CONCLUSIONS: The importance of a reliable pathological diagnosis as obtained by biopsy must not be underestimated. We believe that when performing stereotactic biopsy for intracranial lesions, next to minimising morbidity, one should strive for as high a positive yield as possible. In the present single centre retrospective series, we have shown that using a standardised procedure and careful on-demand intraoperative frozen-section analysis can improve the diagnostic yield of stereotactic brain biopsy procedures as compared to a historical series.

High complication rate of an automatic Tru-Cut biopsy gun device for liver biopsy in cats.

BACKGROUND: Liver biopsies taken with an automatic Tru-Cut biopsy gun device caused unexpected fatal shock reactions in cats. The goal of the present study was to determine if this biopsy device caused more frequent fatal complications than did a semiautomatic device. ANIMALS: All cats referred to the Utrecht University, between October 1, 2002, and October 31, 2004, in which ultrasound-guided Tru-Cut liver biopsies were taken. The indications for liver biopsy were increased liver enzyme activity, increased bile acid concentrations, ultrasonographic abnormalities of the liver, ultrasonographic abnormalities of the bile ducts, or some combination of these findings. Coagulation parameters were normal. METHODS: From October 1, 2002, until October 31, 2003, 26 cats were biopsied with an automatic biopsy device. Between November 1, 2003, and October 31, 2004, 19 cats underwent liver biopsy with a semiautomatic biopsy device. RESULTS: In the first period. 5 of the 26 cats (19%) developed severe shock within 15 minutes. Resuscitation was not successful. In the second period, none of the 19 cats experienced any major adverse effect. There were no significant differences between the 2 groups with respect to diagnosis, clinical signs, clinicopathologic findings, or the use of anesthetics. CONCLUSIONS AND CLINICAL IMPORTANCE: We conclude that the difference in complication rate is explained by the biopsy technique used. The pressure wave, which occurs when firing the automatic device, may have caused intense vagotonia and shock. Use of this automatic biopsy device should be avoided in cats because of the high risk of fatal complications.

Surgery for primary supratentorial brain tumors in the United States, 1988 to 2000: the effect of provider caseload and centralization of care.

Contemporary reports of patient outcomes after biopsy or resection of primary brain tumors typically reflect results at specialized centers. Such reports may not be representative of practices in nonspecialized settings. This analysis uses a nationwide hospital discharge database to examine trends in mortality and outcome at hospital discharge in 38,028 admissions for biopsy or resection of supratentorial primary brain tumors in adults between 1988 and 2000, particularly in relation to provider caseload. Multivariate analyses showed that large-volume centers had lower in-hospital postoperative mortality rates than centers with lighter caseloads, both for craniotomies (odds ratio [OR] 0.75 for a tenfold larger caseload) and for needle (closed) biopsies (OR 0.54). Adverse discharge disposition was also less likely at high-volume hospitals, both for craniotomies (OR 0.77) and for needle biopsies (OR 0.67). The annual number of surgical admissions increased by 53% during the 12-year study period, and in-hospital mortality rates decreased during this period, from 4.8% to 1.8%. Mortality rates decreased over time, both for craniotomies and for needle biopsies. Subgroup analyses showed larger relative mortality rate reductions at large-volume centers than at small-volume centers (73% vs. 43%, respectively). The number of US hospitals performing one or more craniotomies annually for primary brain tumors decreased slightly, and the number performing needle biopsies increased. There was little change in median hospital annual craniotomy caseloads, but the largest centers had disproportionate growth in volume. The 100 highest-caseload US hospitals accounted for an estimated 30% of the total US surgical primary brain tumor caseload in 1988 and 41% in 2000. Our findings do not establish minimum volume thresholds for acceptable surgical care of primary brain tumors. However, they do suggest a trend toward progressive centralization of craniotomies for primary brain tumor toward large-volume US centers during this interval.

Complications Following Stereotactic Needle Biopsy of Intracranial Tumors.

BACKGROUND: Data from single-institution studies suggest that perioperative complication rates after stereotactic needle brain biopsies range from 6% to 12%, with permanent morbidity and mortality ranging from 3.1% to 6.4% and 0% to 1.7%, respectively. However, no population-level data are available. We conducted a population-based analysis to study complications after needle brain biopsy. METHODS: We analyzed patients recorded in the Nationwide Inpatient Sample who underwent stereotactic needle brain biopsy for neoplastic lesions between 2006 and 2012. A multivariate logistic model was used to identify factors associated with complications. RESULTS: We identified 7514 patients who underwent biopsy for various intracranial pathologies, including primary malignant neoplasm (52.3%), unspecified neoplasm (17.9%), metastasis (9.7%), meningioma (1.5%), radiation necrosis (0.8%), lymphoma (0.5%), and pineal region neoplasm (0.3%). Intracranial hemorrhage was the most frequent complication (5.8%). Other complications, including operative infection (0.1%) and wound breakdown (0.2%), were rare. Multivariate logistic regression analysis revealed that hemorrhage is associated with older age (reference <40 years; 40-59 years, odds ratio [OR] 2.26, 95% confidence interval [CI] 1.51-3.38; ≥60 years, OR 1.90, 95% CI 1.22-2.97), hydrocephalus (OR 3.02, 95% CI 2.20-4.14), and cerebral edema (OR 2.16, 95% CI 1.72-2.72). Hemorrhage is less likely when taking a biopsy from a primary malignant neoplasm (OR 0.73, 95% CI 0.59-0.90). Overall inpatient mortality after biopsy was 2.8%. Patients with intracranial hemorrhage were significantly more likely than patients without hemorrhage to die in the hospital (12.8% vs. 2.2%, P < 0.001) or be discharged to a rehabilitation/nursing facility (45.2% vs. 23.1%, P < 0.001). CONCLUSIONS: Intracranial hemorrhage is the most frequent complication associated with needle brain biopsy and is associated with inpatient mortality and hospital disposition. Other complications are rare.

Needle aspiration of the lung in complex pneumonias.

In 39 patients with treated unresponsive pneumonia complicated by life-threatening underlying disease, direct needle aspiration of the lung was performed to establish a cause. An infectious agent was detected in 18 patients (46 percent), a nonbacterial cause was found in one, and cure of a recent infection was substantiated in six patients. An incorrect diagnosis was made in seven patients (one false-positive and six false-negative), and an indeterminant answer was obtained by needle aspiration in seven. Serious complications occurred in 11 patients, most commonly in those who had hypoxia or thrombocytopenia, but no morbidity occurred in 22 patients. The diagnostic yield allowed effective rational therapy to be selected for multiple potential pathogens in 12 patients and detected pathogens not suspected in six instances. The technique compares favorably to other invasive techniques for establishing definitive information in this group of seriously ill patients.

Brain biopsy sampling by using prospective stereotaxis and a trajectory guide.

OBJECT: The authors describe their initial results obtained using a skull-mounted trajectory guide for intraoperative magnetic resonance (MR) imaging-guided brain biopsy sampling. The device was used in conjunction with a new methodology known as prospective stereotaxis for surgical trajectory alignment. METHODS: Between January 1999 and March 2000, 38 patients underwent 40 brain biopsy procedures in which prospective stereotaxis was performed with the trajectory guide in a short-bore 1.5-tesla MR imager. In most cases, orthogonal T2-weighted half-Fourier acquisition single-shot turbo spin-echo (HASTE) images were used to determine the desired trajectory and align the device. The surgical trajectory was defined as a line connecting three points: the target, pivot, and alignment stem points. In all cases, surgical specimens were submitted for frozen section and pathological examination. Postoperative turbofluid-attenuated inversion-recovery and gradient-echo images were obtained to exclude the presence of hemorrhage. Trajectory determination and alignment was simple and efficient, requiring less than 5 minutes. Confirmatory HASTE images were obtained along the biopsy needle as it was being advanced or after reaching the target. All biopsy procedures yielded diagnostic tissue. One patient with a lesion near the motor strip experienced a transient hemiparesis of the hand related to passage of the biopsy needle, and another sustained a fatal postoperative myocardial infarction. No patient suffered a clinically significant or radiologically visible hemorrhage. CONCLUSIONS: In combination with prospective stereotaxis, the trajectory guide provided a safe and accurate way to perform brain biopsy procedures.

[The stereotaxic biopsy of tumors in the pineal area]. / Stereotaksicheskaia biopsiia opukholei pineal'noi oblasti.

The outcomes of stereotactic biopsy (STB) of pineal tumors are presented. This diagnostic approach was applied in 51 patients aged 7 to 59 years (mean 23 years) and its main indication is to develop an adequate treatment policy by specifying the histological structure of a tumor. Informative morphological samples were taken in 42 (82%) cases. One patient died, another developed a persistent neurological defect after STB. A third of all cases was diagnosed as having germinomas and other 5 patients were found to have germinative cellular tumors of mixed structure, which reflects the views on the policy of examination and treatment of patients with pineal tumors and indications for the biopsy, which have been established at the N. N. Burdenko Institute of Neurosurgery, Russian Academy of Medical Sciences. In 14 cases, STB diagnosis was verified from 1 to 46 weeks of postbioptic surgery connected with tumor removal or autopsy. There was 100% coincidence in histological diagnosis. Indications for STB in patients with pineal tumors, the significance of its findings, methodological and technical aspects, as well as the clinical value of this diagnostic procedure are dealt with in the paper.

Greatest percentage of involved core length and the risk of death from prostate cancer in men with highest Gleason score ≥ 7.

INTRODUCTION/BACKGROUND: Men with highest GS ≥ 7 and a differing, lower GS core (ComboGS) have decreased PC-specific mortality (PCSM) risk after RT or RT and androgen deprivation therapy (ADT). Whether the greatest percentage of involved core length (GPC) modulates this risk is unknown. PATIENTS AND METHODS: Men with GS ≥ 7 PC (n = 333) consecutively treated between December 1989 and July 2000 using RT (n = 268; 80%) or RT and 6 months of ADT (n = 65; 20%) comprised the study cohort. The GPC was calculated using biopsy core and tumor lengths. We used competing risks regression to assess whether increasing GPC was associated with increased PCSM risk in men with or without ComboGS adjusting for risk group, age, and treatment. RESULTS: After a median follow-up of 5.36 years (interquartile range, 3.22-7.61 years), 92 (28%) men died, 28 (30%) of PC. Increasing GPC was significantly associated with increased risk of PCSM (adjusted hazard ratio, 1.02; 95% confidence interval, 1.01-1.03; P = .005). Men with GPC ≥ 50% versus < 50% had significantly greater PCSM estimates when ComboGS was present (P < .001) versus absent (P = .55). Of the 127 men with ComboGS and GPC < 50%, 83% were treated with RT alone and 2 PC deaths were observed; neither in men with GS 7 and favorable intermediate-risk PC. CONCLUSION: Men treated with RT for ComboGS, GPC < 50%, GS 7, and favorable intermediate-risk PC have a very low risk of early PCSM. The RTOG 0815 trial will establish whether ADT is necessary to optimize curability in these men.

[Sample representativeness and incidence of liver biopsy complications caused by needles of bigger diameter (1.6 mm) and smaller diameter (1.2 mm) in children with cholestatic syndrome].

INTRODUCTION: Percutaneous liver biopsy and histomorphological analysis of liver tissue is an important diagnostic procedure in the investigation of neonates and infants with cholestatic syndrome. This study has been aimed at determining whether there is a difference in the incidence of complications after liver biopsy performed by Menghini technique using a needle of 1.6 mm as compared to 1.2 mm diameter and if there is a difference in the sample representativeness of liver tissue after liver biopsy with those two different needle diameters. MATERIAL AND METHODS: We retrospectively reviewed medical records of 156 neonates and infants with chronic cholestatic syndrome, hospitalized at Mother and Child Health Care Institute, Serbia. RESULTS: One hundred and fifty six children underwent liver biopsy. There was no difference in frequency of liver biopsy complications performed by Menghini technique using a larger diameter needle (1.6 mm) as compared to 1.2 mm diameter. The mortality after liver biopsy was 0% while the frequency of complications with a needle of 1.6 mm in diameter was 3.8% the percentage of serious complications being 0.6%. Among the samples of liver biopsy taken by a larger diameter needle (1.6 mm), 108/109 were representative samples (> 5 portal areas), and among those taken by a smaller diameter needle (1.2 mm), 34/47 were representative samples. Of 109 liver biopsy specimens obtained by Menghini technique using a needle of larger diameter (1.6 mm), 109/109 were representative samples (> 3 portal areas), and when a smaller diameter needle (1.2 mm) was used, 42/47 were representative samples. CONCLUSION: Our results indicate that the sample representativeness was significantly higher when a larger diameter needle was used for liver biopsy by Menghini technique; however, no difference in the incidence of complications was observed.

Mortality and discharge to home after closed brain biopsy: analysis of 3523 cases from the State of California, 2003-2009.

OBJECTIVE: Closed (percutaneous) brain biopsy is an important diagnostic procedure. Information on patient outcomes after biopsy come largely from single-institution series or population-based samples that include patients treated during periods that may not reflect current neurosurgical practice. We sought to determine the rates of in-hospital mortality and discharge to home after closed brain biopsy, and predictors of these outcomes by using a large population-based hospital discharge database with near-complete case ascertainment. METHODS: All closed brain biopsies performed in nonfederal hospitals within the State of California between 2003 and 2009 were identified from a discharge database. Adult patients admitted from home were analyzed; patient-level and hospital-level factors were reviewed for predictors of in-hospital mortality and discharge to home. Logistic regression was used to determine significant predictors of outcome. RESULTS: During the 7-year period, 3523 hospitalizations, including closed brain biopsy, met our inclusion criteria. Overall in-hospital mortality rate was 3.5%, and 67.2% of hospitalizations were followed by discharge directly to home. Scheduled versus unscheduled admission and patient race were predictors of mortality in multivariate analysis. Patient age, hospital biopsy volume, scheduled versus unscheduled admission, and patient race were predictors of discharge to home. CONCLUSIONS: Closed brain biopsy is associated with a greater rate of mortality than is generally recognized. Most patients are able to return to home directly after biopsy, but the rate of discharge to home is lower at hospitals with lower procedure volumes.

Bone marrow biopsy morbidity and mortality: 2002 data.

A survey of morbidity and mortality of bone marrow aspiration and trephine biopsy was carried out for the British Society of Haematology, covering the 12 months of 2002. Fifty-three centres reported 13,506 procedures, comprising 3927 aspiration biopsies and 9579 combined procedures. There were 17 adverse events including nine instances of haemorrhage, four infections and one haemorrhage complicated by infection. Two trephine biopsy needles broke during the procedure. One patient suffered considerable pain for 2 weeks. The adverse event may have contributed to death in two patients and in a third patient was life-threatening. Risk factors for adverse events were identified.

[Complications of fine needle puncture. DEGUM survey II]. / Komplikationen der Feinnadelpunktion. DEGUM-Umfrage II.

AIM: In a follow-up survey of the members of the German Society for Ultrasound in Medicine (DEGUM), the use of several fine-needle puncture techniques as well as the frequency and nature of the complications were assessed. METHOD: A questionnaire was sent to all 3364 members of the society. RESULTS: 95070 fine-needle punctures were reported. Of these, 66379 were done to obtain cytological material (69.8%), 19633 (20.7%) to obtain histological material and 9057 (9.5%) for therapeutic reasons. 38.6% of the punctures were guided by ultrasound (i.e. performed without ultrasonic observation of the puncture process), 35.1% were conducted under ultrasonic view and 26.3% with a special puncture probe. The punctures for cytology were generally done without direct ultrasonic observation (45.6%); the punctures for histology were performed for the most part with puncture probes (56.7%). The therapeutic punctures were monitored with a puncture probe in 52.5%. In 95070 punctures, 765 complications were observed (0.81%), one death (0.0011%) and six metastases in the puncture canal (0.0063%); 0.71% slight and 0.095% severe complications were recorded. The punctures for cytology caused the fewest complications with 0.59%. Those for histology had a complication rate of 0.99% and the therapeutic punctures one of 1.98%. In comparison to our first survey in 1988, complications increased from 0.51% to 0.81% primarily because of increased slight complications, which rose from 0.44% to 0.71%. The severe complications rose from 0.057% to 0.095%. Deaths decreased from 0.0075% to 0.0011%. Metastases in the puncture canal were likewise observed more frequently than in the first survey (0.0063% versus 0.003%). The increase in frequency of complications was predominantly the result of a more careful registration, but also by a wider use of the techniques. CONCLUSION: Ultrasonically guided fine-needle puncture is a method with a low rate of complications, but even this slightly invasive method requires stringent indications.

Percutaneous biopsy in diffuse liver disease: increasing diagnostic yield and decreasing complication rate by routine ultrasound assessment of puncture site.

OBJECTIVE: To evaluate the usefulness of routine ultrasound assessment of puncture site before performing percutaneous biopsy in diffuse liver disease. Seven hundred fifty-three consecutive patients were studied retrospectively. METHODS: Serial scanning of the last intercostal spaces allowed us to establish the most suitable access to the thicker liver parenchyma (assessing the most favorable angulation of the needle too), avoiding the puncture of adjacent organs; no more than 1 min was necessary for such a determination. RESULTS: In 99.4% of patients, a definitive or indicative pathological diagnosis of chronic liver disease was obtained. Only one hemorrhagic complication (0.13%) occurred, requiring no surgical treatment or blood transfusion. Three cases of vasovagal reaction occurred (0.40%): two of these recovered spontaneously, while the other one needed i.v. administration of atropine. Mortality was 0 in our series. CONCLUSIONS: Routine ultrasound of the puncture site is a quick method of assessment, allowing one to increase the diagnostic yield of percutaneous liver biopsy and to maintain low complication rates for such a procedure.