Kaiser Permanente Moanalua Medical Center

BACKGROUND: Evidence from large, randomized, controlled peripheral artery disease trials reporting long-term outcomes using drug-coated balloons (DCBs) is limited. Previously, the DCB showed favorable 1-year outcomes compared with conventional percutaneous transluminal angioplasty (PTA), yet durability of the treatment effect with DCBs remains unknown. OBJECTIVES: This study sought to investigate the longer-term outcomes of a paclitaxel-eluting DCB compared to PTA for femoropopliteal lesions. METHODS: We enrolled 331 patients with symptomatic (Rutherford 2 to 4) femoropopliteal lesions up to 18 cm in length. Patients were randomly assigned in a 2:1 ratio to treatment with DCB or PTA. The 24-month assessments included primary patency, freedom from clinically driven target lesion revascularization (CD-TLR), major adverse events, and quality of life and functional outcomes as assessed by the EuroQOL-5D quality-of-life questionnaire, walking impairment questionnaire, and 6-min walk test. RESULTS: At 24 months, patients treated with DCB showed significantly higher primary patency when compared with PTA (78.9% vs. 50.1%; p < 0.001). The rates of CD-TLR were 9.1% and 28.3% (p < 0.001) for the DCB and PTA groups, respectively. The overall mortality rate in the DCB group was 8.1% versus 0.9% in the PTA group (p = 0.008). There were no device- or procedure-related deaths and no major amputations in either group through 24-month follow-up. The rate of vessel thrombosis was low (1.5% DCB vs. 3.8% PTA; p = 0.243), with no new events reported between 1 and 2 years. Both groups showed similar functional improvement at 2 years, although DCB patients achieved this level of function with 58% fewer reinterventions. CONCLUSIONS: The 24-month outcomes from the trial demonstrate a durable and superior treatment effect of DCB versus PTA with significantly higher primary patency, lower CD-TLR, and similar functional status improvement with fewer repeat interventions. (Randomized Trial of IN.PACT Admiral Drug Eluting Balloon vs Standard PTA for the Treatment of SFA and Proximal Popliteal Arterial Disease [INPACT SFA I]; NCT01175850; and IN.PACT Admiral Drug-Coated Balloon vs. Standard Balloon Angioplasty for the Treatment of Superficial Femoral Artery [SFA] and Proximal Popliteal Artery [PPA] [INPACT SFA II]; NCT01566461).

Importance: Chronic kidney disease (low estimated glomerular filtration rate [eGFR] or albuminuria) affects approximately 14% of adults in the US. Objective: To evaluate associations of lower eGFR based on creatinine alone, lower eGFR based on creatinine combined with cystatin C, and more severe albuminuria with adverse kidney outcomes, cardiovascular outcomes, and other health outcomes. Design, Setting, and Participants: Individual-participant data meta-analysis of 27 503 140 individuals from 114 global cohorts (eGFR based on creatinine alone) and 720 736 individuals from 20 cohorts (eGFR based on creatinine and cystatin C) and 9 067 753 individuals from 114 cohorts (albuminuria) from 1980 to 2021. Exposures: The Chronic Kidney Disease Epidemiology Collaboration 2021 equations for eGFR based on creatinine alone and eGFR based on creatinine and cystatin C; and albuminuria estimated as urine albumin to creatinine ratio (UACR). Main Outcomes and Measures: The risk of kidney failure requiring replacement therapy, all-cause mortality, cardiovascular mortality, acute kidney injury, any hospitalization, coronary heart disease, stroke, heart failure, atrial fibrillation, and peripheral artery disease. The analyses were performed within each cohort and summarized with random-effects meta-analyses. Results: Within the population using eGFR based on creatinine alone (mean age, 54 years [SD, 17 years]; 51% were women; mean follow-up time, 4.8 years [SD, 3.3 years]), the mean eGFR was 90 mL/min/1.73 m2 (SD, 22 mL/min/1.73 m2) and the median UACR was 11 mg/g (IQR, 8-16 mg/g). Within the population using eGFR based on creatinine and cystatin C (mean age, 59 years [SD, 12 years]; 53% were women; mean follow-up time, 10.8 years [SD, 4.1 years]), the mean eGFR was 88 mL/min/1.73 m2 (SD, 22 mL/min/1.73 m2) and the median UACR was 9 mg/g (IQR, 6-18 mg/g). Lower eGFR (whether based on creatinine alone or based on creatinine and cystatin C) and higher UACR were each significantly associated with higher risk for each of the 10 adverse outcomes, including those in the mildest categories of chronic kidney disease. For example, among people with a UACR less than 10 mg/g, an eGFR of 45 to 59 mL/min/1.73 m2 based on creatinine alone was associated with significantly higher hospitalization rates compared with an eGFR of 90 to 104 mL/min/1.73 m2 (adjusted hazard ratio, 1.3 [95% CI, 1.2-1.3]; 161 vs 79 events per 1000 person-years; excess absolute risk, 22 events per 1000 person-years [95% CI, 19-25 events per 1000 person-years]). Conclusions and Relevance: In this retrospective analysis of 114 cohorts, lower eGFR based on creatinine alone, lower eGFR based on creatinine and cystatin C, and more severe UACR were each associated with increased rates of 10 adverse outcomes, including adverse kidney outcomes, cardiovascular diseases, and hospitalizations.

BACKGROUND: Although measuring albuminuria is the preferred method for defining and staging chronic kidney disease (CKD), total urine protein or dipstick protein is often measured instead. OBJECTIVE: To develop equations for converting urine protein-creatinine ratio (PCR) and dipstick protein to urine albumin-creatinine ratio (ACR) and to test their diagnostic accuracy in CKD screening and staging. DESIGN: Individual participant-based meta-analysis. SETTING: 12 research and 21 clinical cohorts. PARTICIPANTS: 919 383 adults with same-day measures of ACR and PCR or dipstick protein. MEASUREMENTS: Equations to convert urine PCR and dipstick protein to ACR were developed and tested for purposes of CKD screening (ACR ≥30 mg/g) and staging (stage A2: ACR of 30 to 299 mg/g; stage A3: ACR ≥300 mg/g). RESULTS: Median ACR was 14 mg/g (25th to 75th percentile of cohorts, 5 to 25 mg/g). The association between PCR and ACR was inconsistent for PCR values less than 50 mg/g. For higher PCR values, the PCR conversion equations demonstrated moderate sensitivity (91%, 75%, and 87%) and specificity (87%, 89%, and 98%) for screening (ACR >30 mg/g) and classification into stages A2 and A3, respectively. Urine dipstick categories of trace or greater, trace to +, and ++ for screening for ACR values greater than 30 mg/g and classification into stages A2 and A3, respectively, had moderate sensitivity (62%, 36%, and 78%) and high specificity (88%, 88%, and 98%). For individual risk prediction, the estimated 2-year 4-variable kidney failure risk equation using predicted ACR from PCR had discrimination similar to that of using observed ACR. LIMITATION: Diverse methods of ACR and PCR quantification were used; measurements were not always performed in the same urine sample. CONCLUSION: Urine ACR is the preferred measure of albuminuria; however, if ACR is not available, predicted ACR from PCR or urine dipstick protein may help in CKD screening, staging, and prognosis. PRIMARY FUNDING SOURCE: National Institute of Diabetes and Digestive and Kidney Diseases and National Kidney Foundation.

BACKGROUND: Our purpose was to identify infants with a bilateral, permanent, handicapping hearing loss and to provide them with amplification before age 6 months. METHODOLOGY: The study population consisted of 10,372 infants born during a 5-year period. Universal hearing screening by automated auditory brainstem response was done in the nursery. Infants who failed the screening test were followed up diagnostically. Infants who were not tested in the nursery were followed up as outpatients. Hearing aids were recommended for those infants who had bilateral hearing loss. RESULTS: Successful screening in the nursery was achieved for 96% of infants. The failure rate was 4%. The incidence of bilateral loss requiring amplification was 1.4/1000. The false-positive rate was 3.5% after the initial screening and .2% when a two-stage screening procedure was used. The incidence of congenital bilateral hearing loss in the well population was 1/1000, and in the neonatal intensive care unit population, 5/1000. The cost of screening was $17 per infant, and the cost to identify each true bilateral hearing loss was $17,750. Amplification was recommended for 15 infants; well infants who used hearing aids before age 6 months achieved age-appropriate speech and language development. CONCLUSIONS: Mild, moderate, and severe bilateral, persistent hearing loss can be identified in the nursery by automated auditory brainstem response measurement to provide amplification before age 6 months and thus optimize speech and language development.

Capillary malformation-arteriovenous malformation (CM-AVM) is an autosomal-dominant disorder, caused by heterozygous RASA1 mutations, and manifesting multifocal CMs and high risk for fast-flow lesions. A limited number of patients have been reported, raising the question of the phenotypic borders. We identified new patients with a clinical diagnosis of CM-AVM, and patients with overlapping phenotypes. RASA1 was screened in 261 index patients with: CM-AVM (n = 100), common CM(s) (port-wine stain; n = 100), Sturge-Weber syndrome (n = 37), or isolated AVM(s) (n = 24). Fifty-eight distinct RASA1 mutations (43 novel) were identified in 68 index patients with CM-AVM and none in patients with other phenotypes. A novel clinical feature was identified: cutaneous zones of numerous small white pale halos with a central red spot. An additional question addressed in this study was the "second-hit" hypothesis as a pathophysiological mechanism for CM-AVM. One tissue from a patient with a germline RASA1 mutation was available. The analysis of the tissue showed loss of the wild-type RASA1 allele. In conclusion, mutations in RASA1 underscore the specific CM-AVM phenotype and the clinical diagnosis is based on identifying the characteristic CMs. The high incidence of fast-flow lesions warrants careful clinical and radiologic examination, and regular follow-up.

OBJECTIVES: To determine the impact of depression on highly active antiretroviral therapy (HAART) adherence and clinical measures and investigate if selective serotonin reuptake inhibitors (SSRIs) improve these measures. DESIGN: Retrospective cohort study. METHODS: In 2 large health maintenance organizations, we measured the effects of depression (with and without SSRI use) on adherence and changes in viral and immunologic control among HIV-infected patients starting a new HAART regimen. HAART adherence, HIV RNA levels, and changes in CD4 T-cell counts through 12 months were measured. RESULTS: A total of 3359 patients were evaluated; 42% had a depression diagnosis, and 15% used SSRIs during HAART. Depression without SSRI use was associated with significantly decreased odds of achieving > or =90% adherence to HAART (odds ratio [OR] = 0.81, 95% confidence interval [CI]: 0.70 to 0.98; P = 0.03). Depression was associated with significantly lower odds of an HIV RNA level <500 copies/mL (OR = 0.77, 95% CI: 0.62 to 0.95; P = 0.02). Depressed patients compliant with SSRI medication (>80% adherence to SSRI) had HAART adherence and viral control statistically similar to nondepressed HIV-infected patients taking HAART. Comparing depressed with nondepressed HIV-infected patients, CD4 T-cell responses were statistically similar; among depressed patients, those compliant with SSRI had statistically greater increases in CD4 cell responses. CONCLUSIONS: Depression significantly worsens HAART adherence and HIV viral control. Compliant SSRI use is associated with improved HIV adherence and laboratory parameters.

PURPOSE: Intestinal stomas can pose significant challenges for long-term (> or = 5 years) rectal cancer (RC) survivors. Specifying common challenges and sociodemographic or clinical differences will further the development of tailored interventions to improve health-related quality of life (HRQOL). PATIENTS AND METHODS: This was a matched cross-sectional study of long-term RC survivors conducted in three Kaiser Permanente regions. The mailed questionnaire included the modified City of Hope Quality of Life-Ostomy (mCOH-QOL-Ostomy) and Medical Outcomes Study 36-Item Short-Form Health Survey, version 2 (SF-36v2). Groups surveyed were permanent ostomates (cases) and those who did not require an ostomy (controls). RC survivors were matched on sex, age, and time since diagnosis. Comparisons between groups used regression analysis with adjustment for age, comorbidity score, history of radiation therapy, income, and work status. RESULTS: Response rate was 54% (491 of 909). Cases and controls had similar demographic characteristics. On the basis of the mCOH-QOL-Ostomy, both male and female cases had significantly worse social well-being compared with controls, while only female cases reported significantly worse overall HRQOL and psychological well-being. For younger females (< age 75 years), ostomy had a greater impact on physical well-being compared with older females. Based on the SF-36v2, statistically significant and meaningful differences between female cases and controls were observed for seven of the eight scales and on the physical and mental component summary scores. CONCLUSION: Men and women report a different profile of challenges, suggesting the need for targeted or sex-specific interventions to improve HRQOL in this population. This may include focus on physical HRQOL for female ostomy survivors younger than age 75.

OBJECTIVE: To evaluate the associations between adiposity measures (body mass index, waist circumference, and waist-to-height ratio) with decline in glomerular filtration rate (GFR) and with all cause mortality. DESIGN: Individual participant data meta-analysis. SETTING: Cohorts from 40 countries with data collected between 1970 and 2017. PARTICIPANTS: Adults in 39 general population cohorts (n=5 459 014), of which 21 (n=594 496) had data on waist circumference; six cohorts with high cardiovascular risk (n=84 417); and 18 cohorts with chronic kidney disease (n=91 607). MAIN OUTCOME MEASURES: ) and all cause mortality. RESULTS: Over a mean follow-up of eight years, 246 607 (5.6%) individuals in the general population cohorts had GFR decline (18 118 (0.4%) end stage kidney disease events) and 782 329 (14.7%) died. Adjusting for age, sex, race, and current smoking, the hazard ratios for GFR decline comparing body mass indices 30, 35, and 40 with body mass index 25 were 1.18 (95% confidence interval 1.09 to 1.27), 1.69 (1.51 to 1.89), and 2.02 (1.80 to 2.27), respectively. Results were similar in all subgroups of estimated GFR. Associations weakened after adjustment for additional comorbidities, with respective hazard ratios of 1.03 (0.95 to 1.11), 1.28 (1.14 to 1.44), and 1.46 (1.28 to 1.67). The association between body mass index and death was J shaped, with the lowest risk at body mass index of 25. In the cohorts with high cardiovascular risk and chronic kidney disease (mean follow-up of six and four years, respectively), risk associations between higher body mass index and GFR decline were weaker than in the general population, and the association between body mass index and death was also J shaped, with the lowest risk between body mass index 25 and 30. In all cohort types, associations between higher waist circumference and higher waist-to-height ratio with GFR decline were similar to that of body mass index; however, increased risk of death was not associated with lower waist circumference or waist-to-height ratio, as was seen with body mass index. CONCLUSIONS: Elevated body mass index, waist circumference, and waist-to-height ratio are independent risk factors for GFR decline and death in individuals who have normal or reduced levels of estimated GFR.

Significance Statement Randomized clinical trials of treatments to slow CKD progression often require large sample sizes and long follow-up to understand their effects on clinical events. This is especially true in patients with earlier stages of kidney disease who are unlikely to experience ESKD for many years. Surrogate study end points that occur earlier during disease progression could help. To evaluate whether eGFR decline over time may be a good surrogate end point, the authors did a meta-analysis of 14 cohorts. They found that slower eGFR decline was significantly associated with lower risk of ESKD in all populations, including those with better kidney function. The results suggest that change in the slope of eGFR decline may be a good surrogate end point for ESKD in clinical trials, particularly in longer trials with patients with rapidly progressive disease. Background Decline in eGFR is a biologically plausible surrogate end point for the progression of CKD in clinical trials. However, it must first be tested to ensure strong associations with clinical outcomes in diverse populations, including patients with higher eGFR. Methods To investigate the association between 1-, 2-, and 3-year changes in eGFR (slope) with clinical outcomes over the long term, we conducted a random effects meta-analysis of 3,758,551 participants with baseline eGFR≥60 ml/min per 1.73 m 2 and 122,664 participants with eGFR&lt;60 ml/min per 1.73 m 2 from 14 cohorts followed for an average of 4.2 years. Results Slower eGFR decline by 0.75 ml/min per 1.73 m 2 per year over 2 years was associated with lower risk of ESKD in participants with baseline eGFR≥60 ml/min per 1.73 m 2 (adjusted hazard ratio, 0.70; 95% CI, 0.68 to 0.72) and eGFR&lt;60 ml/min per 1.73 m 2 (0.71; 95% CI, 0.68 to 0.74). The relationship was stronger with 3-year slope. For a rapidly progressing population with predicted 5-year risk of ESKD of 8.3%, an intervention that reduced eGFR decline by 0.75 ml/min per 1.73 m 2 per year over 2 years would reduce the ESKD risk by 1.6%. For a hypothetical low-risk population with a predicted 5-year ESKD risk of 0.58%, the same intervention would reduce the risk by only 0.13%. Conclusions Slower decline in eGFR was associated with lower risk of subsequent ESKD, even in participants with eGFR≥60 ml/min per 1.73 m 2 , but those with the highest risk would be expected to benefit the most.

Orthopedic procedures represent a large expense to the Medicare program, and costs of implantable medical devices account for a large proportion of those procedures' costs. Physicians have been encouraged to consider cost in the selection of devices, but several factors make acquiring cost information difficult. To assess physicians' levels of knowledge about costs, we asked orthopedic attending physicians and residents at seven academic medical centers to estimate the costs of thirteen commonly used orthopedic devices between December 2012 and March 2013. The actual cost of each device was determined at each institution; estimates within 20 percent of the actual cost were considered correct. Among the 503 physicians who completed our survey, attending physicians correctly estimated the cost of the device 21 percent of the time, and residents did so 17 percent of the time. Thirty-six percent of physicians and 75 percent of residents rated their knowledge of device costs "below average" or "poor." However, more than 80 percent of all respondents indicated that cost should be "moderately," "very," or "extremely" important in the device selection process. Surgeons need increased access to information on the relative prices of devices and should be incentivized to participate in cost containment efforts.

BACKGROUND AND OBJECTIVES: Evaluation of renal function by estimation of the glomerular filtration rate (GFR) is very important for the diagnosis and treatment of patients with chronic kidney disease (CKD). The Cockcroft-Gault (CG) and Modification of Diet in Renal Disease (MDRD) formulas are the most commonly used estimations. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: Estimated GFR values by each formula were compared with measured GFR (mGFR) by renal inulin clearance in 2208 European adults (46% women, 1.4% Caribbean blacks), with and without CKD, and mean mGFR 72.4 +/- 39.0 (range 2.2 to 177.2) ml/min/1.73 m(2). RESULTS: Overall, the CG and MDRD formulas showed bias (mean difference) -3.5 ml/min/1.73 m(2) (5.3%), P < 0.001, and -9.8 ml/min/1.73 m(2) (-6.4%), P < 0.001; precision (SD of bias) 21.5 ml/min/1.73 m(2) (43.1%) and 20.0 ml/min/1.73 m(2) (33.0%); limits of agreement (2 SD by Bland-Altman method) 39.5 to -46.5 (range 86.0) ml/min/1.73 m(2) and 30.2 to -49.8 (range 80.0) ml/min/1.73 m(2); and accuracy within +/-30% of mGFR 70.8 and 69.0%, respectively. Both formulas showed a trend for decreasing accuracy with lower mGFR levels. According to the Kidney Disease Outcomes Quality Initiative (K/DOQI)-CKD classification's five GFR groups, the CG and MDRD formulas properly assigned 61.6 and 57.1% of the entire population and had a range of positive predictive values 42.6 to 81.8% and 39.6 to 85.2% and of negative predictive values 81.7 to 96.6% and 76.4 to 97.5%, respectively. CONCLUSIONS: The CG and MDRD formulas had some limitations for proper GFR estimation and K/DOQI-CKD classification by GFR levels alone.

PURPOSE: To test the hypothesis that the rate of coronary artery calcium progression is sex specific, namely, that it is greater in men than in women, and that it is age related, particularly in women. MATERIALS AND METHODS: This was a retrospective study of the progression of coronary artery calcium in 217 consecutive asymptomatic subjects who underwent at least two electron-beam computed tomographic studies of the heart. Calcium in the distribution of the epicardial arteries was quantified by using both the conventional coronary artery calcium score (CCS) and the calcium volume score (CVS). Linear regression models were used to judge the joint influence of various risk factors, including sex and age, on rates of coronary artery calcium progression. RESULTS: This study included 103 women and 114 men. The mean interval between the subjects' first and last studies was 25 months +/- 11 (SD). Regression analyses clearly demonstrated that the amount of coronary artery calcium present at the initial study was the most important determinant of calcium progression. This was true when coronary artery calcium was quantified by using the conventional CCS (P <.001) or CVS (P <.001). Neither sex nor age was a significant predictor of coronary artery calcium progression. Among traditional risk factors, only hypertension (P =.02) and diabetes (P =.01) were significant independent factors for calcium progression. CONCLUSION: In asymptomatic subjects, the initial CCS and CVS were the most important factors that affected rate of coronary artery calcium progression. Neither age nor sex was as important as these factors in determination of coronary artery calcium progression.

BACKGROUND: Internal fixation is currently the standard of care for Garden-I and II femoral neck fractures in elderly patients. However, there may be a degree of posterior tilt (measured on preoperative lateral radiograph) above which failure is likely, and primary arthroplasty would be preferred. The purpose of this analysis was to determine the association between posterior tilt and the risk of subsequent arthroplasty following internal fixation of Garden-I and II femoral neck fractures in elderly patients. METHODS: This study is a preplanned secondary analysis of data collected in the FAITH (Fixation using Alternative Implants for the Treatment of Hip fractures) trial, an international, multicenter, randomized controlled trial comparing the sliding hip screw with cannulated screws in the treatment of femoral neck fractures in patients ≥50 years old. For each patient who sustained a Garden-I or II femoral neck fracture and had an adequate preoperative lateral radiograph, the amount of posterior tilt was categorized as <20° or ≥20°. Multivariable Cox proportional hazards analysis was used to assess the association between posterior tilt and subsequent arthroplasty during the 2-year follow-up period, controlling for potential confounders. RESULTS: Of the 555 patients in the study sample, 67 (12.1%) had posterior tilt ≥20° and 488 (87.9%) had posterior tilt <20°. Overall, 73 (13.2%) of 555 patients underwent subsequent arthroplasty in the 24-month follow-up period. In the multivariable analysis, patients with posterior tilt ≥20° had a significantly higher risk of subsequent arthroplasty compared with those with posterior tilt <20° (22.4% [15 of 67] compared with 11.9% [58 of 488]; hazard ratio, 2.22; 95% confidence interval, 1.24 to 4.00; p = 0.008). The other factor associated with subsequent arthroplasty was age ≥80 years (p = 0.03). CONCLUSIONS: In this analysis of patients with Garden-I and II femoral neck fractures, posterior tilt ≥20° was associated with a significantly increased risk of subsequent arthroplasty. Primary arthroplasty may be considered for Garden-I and II femoral neck fractures with posterior tilt ≥20°, especially among older patients. LEVEL OF EVIDENCE: Prognostic Level IV. See Instructions for Authors for a complete description of levels of evidence.

BACKGROUND: Patients are increasingly using physician review websites to find "a good doctor." However, to our knowledge, no prior study has examined the relationship between online rating and an accepted measure of quality. OBJECTIVE: The purpose of this study was to assess the association between online physician rating and an accepted measure of quality: 30-day risk-adjusted mortality rate following coronary artery bypass graft (CABG) surgery. METHODS: In the US states of California, Massachusetts, New Jersey, New York, and Pennsylvania-which together account for over one-quarter of the US population-risk-adjusted mortality rates are publicly reported for all cardiac surgeons. From these reports, we recorded the 30-day mortality rate following isolated CABG surgery for each surgeon practicing in these 5 states. For each surgeon listed in the state reports, we then conducted Internet-based searches to determine his or her online rating(s). We then assessed the relationship between physician online rating and risk-adjusted mortality rate. RESULTS: Of the 614 surgeons listed in the state reports, we found 96.1% (590/614) to be rated online. The average online rating was 4.4 out of 5, and 78.7% (483/614) of the online ratings were 4 or higher. The median number of reviews used to formulate each rating was 4 (range 1-89), and 32.70% (503/1538) of the ratings were based on 2 or fewer reviews. Overall, there was no correlation between surgeon online rating and risk-adjusted mortality rate (P=.13). Risk-adjusted mortality rates were similar for surgeons across categories of average online rating (P>.05), and surgeon average online rating was similar across quartiles of surgeon risk-adjusted mortality rate (P>.05). CONCLUSIONS: In this study of cardiac surgeons practicing in the 5 US states that publicly report outcomes, we found no correlation between online rating and risk-adjusted mortality rates. Patients using online rating websites to guide their choice of physician should recognize that these ratings may not reflect actual quality of care as defined by accepted metrics.

INTRODUCTION: Placenta percreta invading the urinary bladder may cause hemorrhagic shock, hematuria and urologic complications at parturition. This retrospective survey of 54 patients reviews maternal characteristics, presentations, urologic complications, and management. METHODS: The first reported case of placenta percreta with urinary bladder invasion in Hawaii is presented. Medline search and literature review identified an additional 53 patients. A meta-analysis of all 54 cases was performed. RESULTS: Hematuria was present initially in 31% (17/54) patients. Of these, 9 of 17 required transfusion support. A preoperative diagnosis was established by ultrasound or MRI in 33% of patients. Cystoscopy was performed in 12 patients and did not make a preoperative diagnosis in any patient. 39 urologic complications included bladder laceration 26%, urinary fistula 13%, gross hematuria 9%, ureteral transection 6%, and small capacity bladder 4%. Partial cystectomy was performed in 44% (24/54). Three maternal deaths and 14 fetal deaths occurred. Only 1 patient subsequently had a delivery. CONCLUSION: Readily identifiable risk factors by history are important to suggest placenta percreta in pregnant patients with gross hematuria. Ultrasound and/or MRI can establish a preoperative diagnosis. Cystoscopy did not identify any patient preoperatively. Partial cystectomy is commonly required for extensive or deep bladder invasion.

The GFR has a paramount diagnostic and staging role in the Kidney Disease Outcome Quality Initiative Clinical Practice Guidelines for Chronic Kidney Disease (K/DOQI-CKD). The most widely used serum creatinine-based formulas in adults for estimated GFR (eGFR) are the Cockcroft-Gault (CG) and Modification of Diet in Renal Disease Study (MDRD). Recently, a new Chronic Kidney Disease Epidemiology Collaboration equation has been developed. Review of the literature revealed that CG and MDRD formulas correctly assigned overall only 64% and 62%, respectively, of the subjects to their actual K/DOQI-CKD classification's GFR groups as determined by measured GFR (mGFR). This suggests that approximately 10 million (38%) subjects may have been misclassified on the basis of estimated CKD prevalence of 26.3 million adults in the United States. The purpose of this review is to help the clinician understand the limitations of using eGFR in daily practice. We also elaborate upon issues such as the differences among markers of mGFR, the validity of adjusting GFR for body surface area in certain populations, the limited data on boundaries for normal mGFR according to age, gender, and race, the need for calibration of a wide spectrum of serum creatinine measurements, the lack of actual eGFR value above 60 ml/min per 1.73 m(2) and reference for normal mGFR in the clinical laboratories' reports, and the performance evaluation of the eGFR formulas. Several pitfalls have to be overcome before we can reliably determine health and disease in daily nephrology practice to preserve the first rule of practicing medicine: primum non nocere.

BACKGROUND AND PURPOSE: CM-AVM is a recently recognized autosomal dominant disorder associated with mutations in RASA1. Arteriovenous lesions have been reported in the brain, limbs, and the face in 18.5% of patients. We report a novel association between RASA1 mutations and spinal arteriovenous anomalies. MATERIALS AND METHODS: In a collaborative study, 5 index patients (2 females, 3 males) with spinal AVMs or AVFs and cutaneous multifocal capillary lesions were investigated for the RASA1 gene mutation. RESULTS: All 5 patients were found to have RASA1 mutation (2 de novo, 3 familial), and all had multifocal capillary malformations at birth. Neurologic deficits developed at ages ranging from infancy to early adulthood. All spinal anomalies (2 AVMs at the conus, 1 AVM at the lumbosacral junction, and 1 cervical and 1 cervicothoracic AVF) were complex, extensive, and fast-flow lesions. All patients required treatment based on the clinical and/or radiologic appearance of the lesions. CONCLUSIONS: To our knowledge, an association of RASA1 mutation and spinal AVM/AVF has not been described. MR imaging screening of patients with characteristic CMs and neurologic symptoms presenting at a young age may be useful in detecting the presence of fast-flow intracranial or intraspinal arteriovenous anomalies before potentially significant neurologic insult has occurred.

BACKGROUND: The representation of women in orthopaedics in the United States remains among the lowest in all fields of medicine, and prior research has suggested that this underrepresentation may stem from lower levels of interest among female medical students. Of the many proposed reasons for this lack of interest, the male-dominated nature of the field is one of the most commonly cited. The purpose of this study was to determine the degree to which the representation of women among orthopaedic faculty and residents influences female medical students at that institution to apply for a residency in orthopaedics. METHODS: Using data provided by the Association of American Medical Colleges, we identified all U.S. medical schools that were affiliated with an orthopaedic surgery department and an orthopaedic surgery residency program (n = 107). For each institution, data on the representation of women among the orthopaedic faculty and residents from 2014 through 2016 were collected, as well as data on the proportion of female medical school graduates who applied to an orthopaedic residency program from 2015 through 2017. The association between institutional factors and the female medical student orthopaedic application rate was assessed. RESULTS: Of 22,707 women who graduated from medical school during the 3-year study period, 449 (1.98%) applied to an orthopaedic surgery residency program. Women who attended medical school at institutions with high orthopaedic faculty sex diversity were more likely to apply for a residency in orthopaedics (odds ratio [OR], 1.30; 95% confidence interval [CI], 1.04 to 1.64; p = 0.023), as were women who attended medical school at institutions with high orthopaedic resident sex diversity (OR, 1.30; 95% CI, 1.05 to 1.61; p = 0.019). CONCLUSIONS: In this study, we found that increased sex diversity among orthopaedic faculty and residents was associated with a greater likelihood that female medical students at that institution would apply for an orthopaedic residency. These results suggest that at least some of the factors currently impeding female medical student interest in orthopaedics may be modifiable. These findings may have important implications for efforts to improve the sex diversity of the field of orthopaedics going forward.

Background Although several clinical breast cancer risk models are used to guide screening and prevention, they have only moderate discrimination. Purpose To compare selected existing mammography artificial intelligence (AI) algorithms and the Breast Cancer Surveillance Consortium (BCSC) risk model for prediction of 5-year risk. Materials and Methods This retrospective case-cohort study included data in women with a negative screening mammographic examination (no visible evidence of cancer) in 2016, who were followed until 2021 at Kaiser Permanente Northern California. Women with prior breast cancer or a highly penetrant gene mutation were excluded. Of the 324 009 eligible women, a random subcohort was selected, regardless of cancer status, to which all additional patients with breast cancer were added. The index screening mammographic examination was used as input for five AI algorithms to generate continuous scores that were compared with the BCSC clinical risk score. Risk estimates for incident breast cancer 0 to 5 years after the initial mammographic examination were calculated using a time-dependent area under the receiver operating characteristic curve (AUC). Results The subcohort included 13 628 patients, of whom 193 had incident cancer. Incident cancers in eligible patients (additional 4391 of 324 009) were also included. For incident cancers at 0 to 5 years, the time-dependent AUC for BCSC was 0.61 (95% CI: 0.60, 0.62). AI algorithms had higher time-dependent AUCs than did BCSC, ranging from 0.63 to 0.67 (Bonferroni-adjusted P < .0016). Time-dependent AUCs for combined BCSC and AI models were slightly higher than AI alone (AI with BCSC time-dependent AUC range, 0.66–0.68; Bonferroni-adjusted P < .0016). Conclusion When using a negative screening examination, AI algorithms performed better than the BCSC risk model for predicting breast cancer risk at 0 to 5 years. Combined AI and BCSC models further improved prediction. © RSNA, 2023 Supplemental material is available for this article.

The advent of drug-coated balloons (DCBs) provides a novel means to locally deliver paclitaxel into the arterial wall without the need of a chronically implanted delivery system. The widespread use of these devices in the clinical arena is contemporary with the introduction and adoption of paclitaxel eluting stents for peripheral vascular intervention. However, DCB remain highly attractive approach as the long-term consequences of permanent metallic implants in peripheral applications are still unknown. Notably, the clinical value of DCB is supported by robust pre-clinical evidence regarding safety and efficacy. Likewise, the clinical value of DCB in patients has also been demonstrated by multiple randomized clinical trials in the superficial femoral artery (SFA) and proximal popliteal artery territory. However, the widespread clinical adoption of DCB into routine clinical practice remains elusive. The evidence on the value of DCB has been summarized in consensus documents and in clinical practice guidelines. In the coronary field, currently available information has been summarized in two comprehensive Experts' Consensus Documents and the European Society of Cardiology (ESC) guidelines on coronary revascularization.1–3 These documents emphasized that not all DCB are created equal and that a ‘class effect’ cannot be anticipated as the results obtained with different DCB are not uniform. This remains a major challenge since many CE marked devices are currently available yet many of these have not been supported by robust clinical results. In the peripheral territory, the information regarding the clinical use of DCB is scarce. Moreover, no previous consensus document exists describing the clinical applications and indications for the use of this technology on this vascular territory. Likewise, specific guidelines have not been issued. Accordingly, the present document addresses this gap in knowledge by providing an evidence-based recommendation for the use of DCB technology in the peripheral vascular territory. This positioning document is the result of multiple discussions between experts in the field of DCB angioplasty and/or peripheral interventions. Experts on the field critically reviewed relevant literature on this dynamic field with the goal to provide a comprehensive framework to guide clinical practice and to discuss challenges and future perspectives supplementing the ESC guideline document.4 In the peripheral field, there are several territories where a gold standard treatment is currently not available and current treatments are of limited efficacy: here DCB may exert an important role. However, a rigid interpretation of our indications should not be pursued, and we believe that it is the responsibility of each physician to find the most appropriate treatment for the specific clinical circumstance. In sharp contrast to percutaneous coronary interventions, peripheral vascular interventions are less dependent on the use of stents. In general, stenting long femoro-popliteal segments with tubular nitinol stents have demonstrated a significant risk of stent fracture due to physiological torsion of the femoral artery potentially resulting in either restenosis or vessel wall damage.5 In the below-the-knee (BTK) arterial distribution, long dedicated stents are not available. In-stent restenosis (ISR) is a major problem and complications related to lower extremity stents do not have clear cut solutions. Clinically available DCBs deliver paclitaxel via conventional angioplasty balloons, trying to overcome the need for scaffolding. The intended effect of the medication is to improve the long-term patency of the revascularization procedure. The only clinically studied drug at this juncture is paclitaxel, which has shown to inhibit cell proliferation and migration due to an irreversible stabilization of intracellular microtubules.6 This results in blocking cell replication during metaphase and anaphase of mitosis. Currently most available DCB use specific carriers to keep paclitaxel on the balloon surface until delivery and to favour its release and maintenance on the vessel wall.7 Currently, there are several DCB in the European market (Table 1) and are being introduced into the US market. Peripheral drug-coated balloons available in the European market In the US the FDA has currently only approved the Lutonix 35 and IN.PACT Admiral devices for human use outside clinical research. FDA, Food and Drug Administration; OTW, over-the-wire; SFA, superficial femoral artery; DCB, drug-coated balloon; DES, drug-eluting stent; RX, rapid exchange. aT. Zeller—VIVA 2014 oral presentation. bD. Scheinert—LINC 2013 oral presentation. cK.L. Schulte—LINC 2014 oral presentation. dS. Duda—EuroPCR 2014 oral presentation. eT. Zeller—VIVA 2014 oral presentation. Peripheral drug-coated balloons available in the European market In the US the FDA has currently only approved the Lutonix 35 and IN.PACT Admiral devices for human use outside clinical research. FDA, Food and Drug Administration; OTW, over-the-wire; SFA, superficial femoral artery; DCB, drug-coated balloon; DES, drug-eluting stent; RX, rapid exchange. aT. Zeller—VIVA 2014 oral presentation. bD. Scheinert—LINC 2013 oral presentation. cK.L. Schulte—LINC 2014 oral presentation. dS. Duda—EuroPCR 2014 oral presentation. eT. Zeller—VIVA 2014 oral presentation. Drug-coated balloon achieve the short-term transfer and long-term retention of paclitaxel to the arterial wall by different biological mechanisms.8 Experimental data have shown that paclitaxel transfer and retention are not necessarily inter-related phenomena and they largely depend on drug morphology and resulting solubility attained during the coating process.9,10 At the present time, a potential mechanism of action explaining long-term drug retention yielding sustained biological efficacy following single-time drug delivery is still matter of controversy. Early experimental data confirmed that paclitaxel transfer into the vessel wall occurs rapidly following balloon inflation.11 In addition, tissue pharmacokinetic studies showed that short-term tissue levels of paclitaxel following balloon delivery were higher compared with drug-eluting stents (DESs)12 and that therapeutic concentrations of paclitaxel were found beyond 28 days in the vessel wall. Also, several publications demonstrated that in combination with bare-metal stents the long-term vessel healing profile appears to be similar to first-generation DES.13 However, despite its documented clinical efficacy in selected clinical scenarios, a potential mechanism of action explaining long-term drug retention and sustained biological effect has not been elucidated for DCB technologies. Several studies have reported the importance of paclitaxel deposits on the vessel surface and long-term tissue retention. A recent publication demonstrated that following DCB dilatation, a proportion of the paclitaxel is retained on the vessel surface and is not acutely dissolved into the tissue. It seemed apparent that arterial wall levels of paclitaxel were driven by the sustained retention of drug on the surface of the vessel wall, thereby maintaining a positive concentration gradient from the vessel surface into the arterial wall. Interestingly, at 7 days tissue concentrations began to equalize the vessel surface levels, providing an explanation about the lack of tissue toxic effects.8 These results largely depended on coating crystallinity and seemed to be consistent with previous reports showing that specific binding to intracellular proteins occurs primarily in the subintimal space and determines arterial transport properties and microtubule binding of paclitaxel.14 As a consequence, the observed tissue half-life of paclitaxel delivered by DCB relates to the slow dissolution of paclitaxel deposits from the vessel surface into arterial tissue in a time-dependent fashion.15 In any case, the resulting tissue levels of paclitaxel at 28 days are above the reported inhibiting concentration (IC) 50 values for human smooth muscle cells (1.4–2 ng/g) and endothelial cell proliferation (1.7–6.8 ng/g).16 Thus, the proposed mechanism of action reconciles the apparent contradiction between the observed short-term supra-therapeutic tissue levels seen right after balloon delivery and the resulting vessel healing profiles seen at the experimental level. The mechanism of action of DCB is an area of intense investigation and likely will unveil several mechanistic pathways that will help the future development of DCB technologies. Several first-in-man randomized trials17–21 and a registry22 using first-generation DCB in femoro-popliteal lesions have shown favourable technical outcomes in terms of late lumen loss (LLL), restenosis rate, and freedom from target lesion revascularization (TLR) when compared with plain old balloon angioplasty (POBA) (Table 2). Currently published or presented pilot multi-centre drug-coated balloon trials with their primary technical endpoint, 6-month late lumen loss and 12-month target lesion revascularization rate aD. Scheinert—LINC 2013 oral presentation. bS. Duda—EuroPCR 2014 oral presentation. Currently published or presented pilot multi-centre drug-coated balloon trials with their primary technical endpoint, 6-month late lumen loss and 12-month target lesion revascularization rate aD. Scheinert—LINC 2013 oral presentation. bS. Duda—EuroPCR 2014 oral presentation. A meta-analysis of these trials23 had TLR as primary endpoint, whereas secondary endpoints were angiographic binary restenosis, LLL, and all-cause mortality. A total of 381 patients were included (DCB, n = 186 vs. POBA, n = 195). The median follow-up was 10.3 months. Angioplasty with DCB vs. POBA reduced TLR (12.2 vs. 27.7%; OR 0.22; 95% CI, 0.13–0.38; P < 0.00001), angiographic restenosis (18.7 vs. 45.5%; OR 0.26; 95% CI, 0.14–0.48; P < 0.0001), and 6-month LLL (−0.05 to 0.50 mm vs. 0.61–1.7 mm; mean difference −0.75 mm; 95% CI, −1.06 to −0.45; P < 0.00001). No mortality difference was observed between DCB and POBA (2.1 vs. 3.2%; OR, 0.99; 95% CI, 0.39–2.49; P = 0.98). In a recent subgroup analysis of the THUNDER trial,24 dissections did not negatively impact the benefit of DCB angioplasty if left alone without stent placement. At the 6-month follow-up, patients with dissection of any grade after treatment with coated balloons (n = 43) had significantly lower LLL than patients with dissection after POBA (n = 43, 0.4 vs. 1.9 mm, P = 0.001). Interestingly, especially patients with severe dissections (grade C–E) seemed to benefit from DCB in terms of LLL (0.4 vs. 2.4 mm, P = 0.05). Up to the 2-year follow-up, TLR was performed in 56% of patients in the control group compared with 10% of patients in the DCB group (P = 0.002). Patients of the THUNDER study were followed for 5 years.25 Over this study period, the cumulative number of patients with TLR was distinctly lower in the DCB group (21 vs. 56%, P = 0.0005). Currently, two large-scale international US IDE (investigational device exemption) trials are still ongoing in their 2-year follow-up phase; however, 1-year data had been presented or published during 2014. The IN.PACT SFA trial26 which enrolled a total of 331 patients with a 2:1 randomization between DCB and POBA, and the Levant II trial (K. Rosenfield, TCT 2014, Washington DC, USA) which enrolled a total of 543 patients in a 2:1 randomization. Both RCTs are supplemented by large-scale registries enrolling, respectively, 1500 and 650 patients. The randomized multi-centre IN.PACT SFA trial revealed that clinically driven TLR rates were significantly lower with the DCB when compared with those achieved with angioplasty (2.4 vs. 20.6%, P < 0.001). Similarly, the primary patency rate achieved with IN.PACT Admiral balloon was 82.2%, while the primary patency achieved with POBA was 52.45% (P < 0.001). Primary patency at 360 days calculated by Kaplan–Meier survival estimates was 89.8% for the DCB group and 66.8% for the POBA group. In the LEVANT II trial which incorporated a ‘blinded follow-up’ in contrast to previous trials, the primary patency at 12 months defined as freedom from both restenosis and TLR was 65.2% for the DCB and 52.6% for control angioplasty demonstrating superior efficacy (P = 0.015). At 12 months, the freedom from clinically driven TLR in the DCB group was attenuated and similar to the control group (87.7 vs. 83.2%, P = 0.208). In this study, both the safety (freedom from death, amputation, reintervention) and efficacy primary endpoints were met; however, the lack of a clinical efficacy of DCB expressed by a TLR rate similar to the control group at 12 months is of concern. In both studies, no device-specific side-effects were reported, no major amputation occurred. Thus, there was no safety concern regarding wash off of a part of the antiproliferative drug into the distal vasculature. In-stent restenosis has been reported to occur in up to 40% of femoro-popliteal lesions treated with BMS within 1 year.27,28 Moreover, the risk of ISR increases with increasing lesion length. As the population with femoro-popliteal stenting continues to increase, occurrence of ISR has become a clinically relevant problem. The treatment of ISR in the femoro-popliteal artery is one of the major remaining challenges of endovascular therapy because treatment modalities such as PTA and cutting balloon angioplasty have failed to provide durable results.29 A single-centre prospective registry, including 39 patients, reported an impressive 1-year primary patency rate of 92.1%30 and a 2-year primary patency of 70.3%.31 Just recently, the data of the vs. PTA for superficial In-stent trial was presented TCT 2014, Washington DC, USA) including patients with ISR in and a mean lesion of in both study The primary was the 6-month restenosis rate which was in favour for the DCB when compared with POBA vs. P = 0.002). At 1-year restenosis rates were and (P = and freedom from clinically driven TLR at days was and (P = In to it is to the lesion with the balloon from vessel segments and to and to vessel after with The for the treatment of lesions or stent the DCB should either the 1) or the stent should be within the area which was with the The balloon should not be and be to the medication to or during of the DCB into the At the present time, lesion is to the risk of drug loss related to potential coating and during lesion with drug-coated of 2014. Drug-coated balloons are not yet in international guidelines because relevant data had not yet been published when literature was performed for the guidelines. the ESC guidelines on peripheral artery included only one about femoro-popliteal studies with drug-eluting balloons in the femoro-popliteal showed short-term patency rates compared with plain balloon to the international the use of DCB in femoro-popliteal and and lesions be highly because the treatment is and and the data are from multiple randomized clinical However, follow-up data are still for DCB as the presented for The results demonstrated significant of patency 2014, USA) and DCB will need to a similar The long-term of endovascular has been remains for clinical The potential and of DCBs are in a of for different and clinical The clinical and technical of and the are artery patency be of benefit in the healing of However, the potential for between an medication and a is not be DCB significantly impact the of after POBA from at 12 months for lesions to at months for lesion of A meta-analysis of angioplasty performed studies published from to that the 1-year patency of POBA was and the rate was the number of approved DCB in the there is a of data on the use of this in the vasculature. Early that restenosis is less than after POBA and to be and with if treatment treated long lesions and angiographic restenosis was of the were and only of presented with In the a trial of DCB vs. POBA, both restenosis vs. P = and TLR vs. P = were reduced at 1 Moreover, vessel was and (P < healing in vs. (P = and there were no significant in terms of major However, the IN.PACT trial that the device not the single-centre study regarding either efficacy or clinical The IN.PACT trial compared the of the IN.PACT DCB with POBA in a to 1 randomization in patients with primary endpoints for efficacy and and safety death, major or patients were at 1-year follow-up for their clinical endpoints whereas a of patients with lesions in an angiographic control for of the technical between the DCB and POBA included mean lesion vs. P = vs. P = and previous target revascularization vs. P = Primary efficacy results of DCB vs. POBA were clinically driven TLR of vs. (P = and LLL of vs. mm (P = Primary safety was vs. (P = and the A safety driven by major 1 was observed in the DCB vs. POBA vs. P = and As a the IN.PACT DCB was from the market. freedom from major in the drug-coated balloon and plain old balloon angioplasty from the 12-month binary restenosis and clinically driven target lesion from the of may the technical use of The of lesions in multiple with a may the technical of medication a with at the and the artery is significantly the of a drug may not be uniform. of is also an of DCB use in the lesions in different with may the for to of the from the to the target lesion and the of the artery and lesion it may be that of the drug is from the balloon surface during the and of the balloon in the is a with It is not clear this will drug due to the less likely of or due to the of the The less need for after angioplasty with POBA is likely to favour DCB, since the need for stenting is a potential patients have lower extremity DCB is for as as there is a potential for of the distal with drug Drug-coated balloons at and to have lower patency than DCB for the proximal and This may be due to the of the in which of the DCB is limited by increasing due to the drug coating with lumen This may result in an drug of the lesion or a significant drug loss due the between vessel wall and balloon However, the patency of these distal may also be due to a effect and that cannot be by In these DCB may not the results of is currently widespread to that DCB is likely to improve the of endovascular for However, the recent results of the IN.PACT study that in terms of safety and lack of efficacy that an of is patients with arterial there are multiple that for no specific recommendation be at this time, including patients with the tissue arterial of the and following POBA, and Patients with of 5 or patency is in these patients, healing and are the and it is not yet clear that DCB will these exists need for investigation of DCB in a of lesion and clinical The combination of followed by drug-coated technology to the for both and long-term an attractive use of these technologies. The a including patients with and using in a 1-year primary patency rate of and in the femoro-popliteal for patients and The stent rate was as as Early single-centre reports of the combination of and DCB has shown in this approach for patients with lower arterial In one the combination of and DCB was compared with and POBA The outcomes were primary patency of in the DCB group compared with in the POBA Also, in lesions the combination of DCB a freedom from clinically driven TLR in patients studied from a Thus, the combination of and DCB to be a treatment to with a approach for arterial the data are in its and the will need to be Just the trial was presented is a pilot study to and the effect of with to a balloon in to the development of a with SFA and/or popliteal lesions were randomized to either DCB or to DCB with lesions were to a and were treated with and were in the DCB in the DCB and in the lesion DCB group. The mean lesion from to In the randomized the primary endpoint, the at 12 months, was similar in both angiographic patency and without was in the DCB and in the DCB rate, defined as a of clinically driven death, and major amputation, was for the randomized DCB for the randomized DCB and for the lesion (P = This pilot study to an benefit for combination therapy in long and lesions which was not observed in the DCB subgroup investigation in randomized trials is the use of DCB with bare-metal nitinol stent on has been stents were in patients in the LEVANT were DCB patients and 12 POBA patients stents. The LLL for the DCB alone and DCB group was and mm, respectively, whereas in the POBA alone and LLL was and mm, not significant for both In the IN.PACT SFA there were reported stents and the outcomes of these become In the SFA trial lesions were bare-metal stent with either DCB or POBA resulting in significant 1-year outcomes for the DCB vs. P = and TLR rate vs. P < The potential for stenting for dissections and vessel attractive at this the indications or guidelines for use remain Peripheral artery is with reduced of and and than 7 patients in the and patients in treatment a to Drug-coated as one of the most recent revascularization that the of TLR in femoro-popliteal interventions are acutely for and compared with standard endovascular such as balloon to the impact of patency rates resulting in reduced TLR rates of DCB and on the long-term The most robust study summarized the clinical efficacy of endovascular DCB, and as femoro-popliteal on the current and most market for drug-eluting peripheral and the device market were The drug-eluting had a lower impact months compared with BMS and POBA in both the US and The US that BMS result in the device to the followed by POBA and DES, with DCB providing the The analysis showed that the in the for to the drug-eluting POBA to the followed by DES, and clinical and the most therapy to the therapy for lesions treated with DCB as to POBA, one TLR be the the US and this in clinical efficacy be obtained at of in the and in a a that of the reported extremity arterial in the US and of reported artery balloon in are currently treated with POBA, a to a DCB for the to an of to US and of to in A analysis on the in the following outcomes a 1-year POBA is than DCB therapy due to despite the DCB However, POBA is than DCB from the The that DCB may be of TLR at 1-year to improve DCB may help to lower total analysis on a on from a from including endovascular DCB, vs. standard of that DCB may be a to POBA with In and DCB to clinical POBA and Drug-coated balloons and the impact and the value to The current the importance of a from to treatments and with In the peripheral field, data from randomized trials in the femoro-popliteal including two studies FDA IN.PACT created clinical evidence for the of DCB a market in the for DCB in this However, data in the area and to market of a device for the about the combination of DCB with or treatment modalities The major of DCB, especially in the coronary is overcome this several have been of drug-coated or the combination with stents. the of than paclitaxel, especially remains and has to be In the by clinical trials and the of clear evidence-based this peripheral at the indications for the use of this technology in peripheral artery The experts find a of DCBs for the treatment of both and femoro-popliteal whereas a limited and use DCBs for the treatment of until future evidence will become available. of from and from and is of the of and is from and from and is for is of and was as on several applications by