Head-to-head Comparison of Transrectal Ultrasound-guided Prostate Biopsy Versus Multiparametric Prostate Resonance Imaging with Subsequent Magnetic Resonance-guided Biopsy in Biopsy-naïve Men with Elevated Prostate-specific Antigen: A Large Prospective Multicenter Clinical Study.

BACKGROUND: There is growing interest to implement multiparametric magnetic resonance imaging (mpMRI) and MR-guided biopsy (MRGB) for biopsy-naïve men with suspected prostate cancer. OBJECTIVE: Primary objective was to compare and evaluate an MRI pathway and a transrectal ultrasound-guided biopsy (TRUSGB) pathway in biopsy-naïve men with prostate-specific antigen levels of ≥3ng/ml. DESIGN, SETTING, AND POPULATION: A prospective, multicenter, powered, comparative effectiveness study included 626 biopsy-naïve patients (from February 2015 to February 2018). INTERVENTION: All patients underwent prebiopsy mpMRI followed by systematic TRUSGB. Men with suspicious lesions on mpMRI also underwent MRGB prior to TRUSGB. MRGB was performed using the in-bore approach. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Clinically significant prostate cancer (csPCa) was defined as grade group ≥2 (Gleason score ≥3+4) in any core. The main secondary objectives were the number of men who could avoid biopsy after nonsuspicious mpMRI, the number of biopsy cores taken, and oncologic follow-up. Differences in proportions were tested using McNemar's test with adjusted Wald confidence intervals for differences of proportions with matched pairs. RESULTS AND LIMITATIONS: The MRI pathway detected csPCa in 159/626 (25%) patients and insignificant prostate cancer (insignPCa) in 88/626 patients (14%). TRUSGB detected csPCa in 146/626 patients (23%) and insignPCa in 155/626 patients (25%). Relative sensitivity of the MRI pathway versus the TRUSGB pathway was 1.09 for csPCa (p=0.17) and 0.57 for insignPCa (p<0.0001). The total number of biopsy cores reduced from 7512 to 849 (-89%). The MRI pathway enabled biopsy avoidance in 309/626 (49%) patients due to nonsuspicious mpMRI. Immediate TRUSGB detected csPCa in only 3% (10/309) of these patients, increasing to 4% (13/309) with 1-yr follow-up. At the same time, TRUSGB would overdetect insignPCa in 20% (63/309). "Focal saturation" by four additional perilesional cores to MRGB improved the detection of csPCa in 21/317 (7%) patients. Compared with the literature, our proportion of nonsuspicious mpMRI cases is significantly higher (27-36% vs 49%) and that of equivocal cases is lower (15-28% vs 6%). This is probably due to the high-quality standard in this study. Therefore, a limitation is the duplication of these results in less experienced centers. CONCLUSIONS: In biopsy-naïve men, the MRI pathway compared with the TRUSGB pathway results in an identical detection rate of csPCa, with significantly fewer insignPCa cases. In this high-quality standard study, almost half of men have nonsuspicious MRI, which is higher compared with other studies. Not performing TRUS biopsy is at the cost of missing csPCa only in 4%. PATIENT SUMMARY: We compared magnetic resonance imaging (MRI) with MRI-guided biopsy against standard transrectal ultrasound biopsy for the diagnosis of prostate cancer in biopsy-naïve men. Our results show that patients can benefit from MRI because biopsy may be omitted in half of men, and fewer indolent cancers are detected, without compromising the detection of harmful disease. Men also need fewer needles to make a diagnosis.

Impact of incidental renal artery stenosis on long-term mortality in patients with peripheral arterial disease undergoing vascular procedure.

OBJECTIVE: In peripheral arterial disease (PAD), mortality is high. Incidental renal artery stenosis (RAS) is a predictor of mortality in PAD patients undergoing angiography. This might be relevant for risk-benefit assessment when vascular surgery is considered, both in terms of perioperative risk, and in terms of life expectancy. METHODS: We studied the prognostic impact of incidental RAS in 488 subjects (334 men, 154 women; mean follow-up 6.0 ± 3.4 years) who underwent angiography for PAD in a single center between 1997 and 2000. Renal arteries were visualized and follow-up data concerning vascular procedures were analyzed. RESULTS: RAS (diameter reduction >50%) was present in 26%. Forty-six percent of study patients underwent a vascular procedure (85% vascular surgery, remainder underwent amputation). Patients that underwent vascular surgery had a better renal function at baseline, less history of stroke, and a larger proportion of smokers. Overall mortality was similar for patients that underwent surgery (54.5%) and those without surgery (49.6%). There was no difference in 90-day postoperative mortality for patients without or with RAS (7.2% vs 10.3%; NS). For subjects that underwent bypass surgery, long-term mortality was substantially and significantly higher among those with RAS (65.1%) vs those without RAS (43.5%). On Cox regression analysis, age was the only independent predictor of 90-day postoperative mortality. The well-known cardiovascular risk factors of age, diabetes mellitus, history of prior peripheral vascular disease, smoking, prior myocardial infarction, prior stroke, and amputation, as well as presence of RAS, were independent predictors for overall mortality. CONCLUSION: In PAD, incidental RAS predicts long-term mortality independent of other risk factors. The elevated mortality is not due to a higher postoperative risk. Subjects presenting with PAD and RAS can therefore undergo vascular procedures with the same risk as other patients.

Computed tomographic measurements of mesh shrinkage after laparoscopic ventral incisional hernia repair with an expanded polytetrafluoroethylene mesh.

BACKGROUND: The potential for shrinkage of intraperitoneally implanted meshes for laparoscopic repair of ventral and incisional hernia (LRVIH) remains a concern. Numerous experimental studies on this issue reported very inconsistent results. Expanded polytetrafluoroethylene (ePTFE) mesh has the unique property of being revealed by computed tomography (CT). We therefore conducted an analysis of CT findings in patients who had previously undergone LRVIH with an ePTFE mesh (DualMesh, WL Gore, Flagstaff, AZ, USA) in order to evaluate the shrinkage of implanted meshes. PATIENTS AND METHODS: Of 656 LRVIH patients with DualMesh, all patients who subsequently underwent CT scanning were identified and only those with precisely known transverse diameter of implanted mesh and with CT scans made more than 3 months postoperatively were selected (n = 40). Two radiologists who were blinded to the size of the implanted mesh measured in consensus the maximal transverse diameter of the meshes by using the AquariusNET program (TeraRecon Inc., San Mateo, CA, USA). Mesh shrinkage was defined as the relative loss of transverse diameter as compared with the original transverse diameter of the mesh. RESULTS: The mean time from LRVIH to CT scan was 17.9 months (range 3-59 months). The mean shrinkage of the mesh was 7.5% (range 0-23.7%). For 11 patients (28%) there was no shrinkage at all. Shrinkage of 1-10% was found in 16 patients (40%), of 10-20% in 10 patients (25%), and of 20-24% in 3 patients (7.5%). No correlation was found regarding the elapsed time between LRVIH and CT, and shrinkage. There were two recurrences, one possibly related to shrinkage. CONCLUSION: Our observations indicate that shrinkage of DualMesh is remarkably lower than has been reported in experimental studies (8-51%). This study is the first to address the problem of shrinkage after intraperitoneal implantation of synthetic mesh in a clinical material.

Incidental renal artery stenosis is an independent predictor of mortality in patients with peripheral vascular disease.

In patients with peripheral vascular disease (PVD), mortality is high and renal artery stenosis (RAS) is a frequent incidental finding. RAS carries a high risk for mortality, but whether incidentally discovered RAS is a risk factor for mortality is unknown. The prognostic impact of incidental RAS for mortality was studied in 550 consecutive patients who underwent intra-arterial digital subtraction angiography for PVD in a single center between 1997 and 2000. In 491 patients (336 men, 155 women; mean follow-up 3.8 +/- 1.9 yr), the renal arteries were visualized and follow-up data were available. RAS (diameter reduction > 50%) was present in 26% of the patients. Mortality in the RAS group was 59 versus 28% in the non-RAS group (odds ratio 3.8; 95% confidence interval 2.5 to 5.7; P < 0.0001). Diabetes, previous myocardial infarction, history of PVD, stroke, and hypertension were more frequent in the RAS group; age was higher and GFR was lower in the RAS group. Therefore, RAS was associated with elevated mortality and increased prevalence of cardiovascular risk factors. Cox regression analysis showed that RAS was an independent predictor for mortality (P = 0.005), along with age, diabetes, smoking, previous myocardial infarction, history of PVD, and stroke. In patients who were evaluated for PVD by digital subtraction angiography, mortality was high. Incidental RAS was a frequent finding and an independent predictor for mortality. Whether RAS is a marker for or, alternatively, a mediator of the poor prognosis and whether prognosis can be improved by specific intervention should be the subject of future prospective studies.