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Journal of Vascular and Interventional Radiology | 2015

Prostatic Artery Embolization for Treatment of Benign Prostatic Hyperplasia in Patients with Prostates > 90 g: A Prospective Single-Center Study

André Moreira de Assis; Airton Mota Moreira; Vanessa Cristina de Paula Rodrigues; Eduardo Muracca Yoshinaga; Alberto A. Antunes; Sardis Honoria Harward; Miguel Srougi; Francisco Cesar Carnevale

PURPOSE To describe the safety and efficacy of prostatic artery embolization (PAE) with spherical microparticles to treat lower urinary tract symptoms associated with benign prostatic hyperplasia in patients with prostate volume > 90 g. MATERIALS AND METHODS This prospective, single-center, single-arm study was conducted in 35 patients with prostate volumes ranging from 90-252 g. Mean patient age was 64.8 years (range, 53-77 y). Magnetic resonance imaging, uroflowmetry, and the International Prostate Symptom Score (IPSS) were used to assess clinical and functional outcomes. RESULTS Mean prostate size decreased significantly from 135.1 g before PAE to 91.9 g at 3 months of follow-up (P < .0001). Mean IPSS and quality-of-life index improved from 18.3 to 2.7 and 4.8 to 0.9 (P < .0001 for both), respectively. A significant negative correlation was observed between prostate-specific antigen at 24 hours after PAE and IPSS 3 months after PAE (P = .0057). CONCLUSIONS PAE is a safe and effective treatment for lower urinary tract symptoms secondary to benign prostatic hyperplasia in patients with prostate volume > 90 g. Excessively elevated prostate-specific antigen within 24 hours of PAE is associated with lower symptom burden in short-term follow-up.


BMC International Health and Human Rights | 2016

Early childhood development in Rwanda: a policy analysis of the human rights legal framework.

Agnes Binagwaho; Kirstin W. Scott; Sardis Honoria Harward

BackgroundEarly childhood development (ECD) is a critical period that continues to impact human health and productivity throughout the lifetime. Failing to provide policies and programs that support optimal developmental attainment when such services are financially and logistically feasible can result in negative population health, education and economic consequences that might otherwise be avoided. Rwanda, with its commitment to rights-based policy and program planning, serves as a case study for examination of the national, regional, and global human rights legal frameworks that inform ECD service delivery.DiscussionIn this essay, we summarize key causes and consequences of the loss of early developmental potential and how this relates to the human rights legal framework in Rwanda. We contend that sub-optimal early developmental attainment constitutes a violation of individuals’ rights to health, education, and economic prosperity. These rights are widely recognized in global, regional and national human rights instruments, and are guaranteed by Rwanda’s constitution. Recent policy implementation by several Rwandan ministries has increased access to health and social services that promote achievement of full developmental potential. These ECD-centric activities are characterized by an integrated approach to strengthening the services provided by several public sectors. Combining population level activities with those at the local level, led by local community health workers and women’s councils, can bolster community education and ensure uptake of ECD services.ConclusionsRealization of the human rights to health, education, and economic prosperity requires and benefits from attention to the period of ECD, as early childhood has the potential to be an opportunity for expedient intervention or the first case of human rights neglect in a lifetime of rights violations. Efforts to improve ECD services and outcomes at the population level require multisector collaboration at the highest echelons of government, as well as local education and participation at the community level.


Journal of Vascular and Interventional Radiology | 2017

Role of Coil Embolization during Prostatic Artery Embolization: Incidence, Indications, and Safety Profile☆

Shivank Bhatia; Vishal K. Sinha; Matthew Bordegaray; I. Kably; Sardis Honoria Harward; Govindarajan Narayanan

PURPOSE To determine if coil embolization is a safe adjunctive measure to prevent nontarget embolization during prostatic artery embolization (PAE). MATERIALS AND METHODS A retrospective analysis of patients who underwent PAE with coil embolization (cPAE) or without coil embolization (nPAE) between January 2014 and June 2016 was conducted. Adverse events, identified in accordance with SIR guidelines, and procedural variables were compared between the 2 cohorts. RESULTS Of 122 patients, 32 (26.2%) underwent coil embolization in 39 arteries, with coils placed to prevent nontarget embolization (n = 36), treat prostatic artery extravasation (n = 2), and occlude an intraprostatic arteriovenous fistula (n = 1). Compared with nPAE, cPAE had a nonsignificant increase in dose area product (64,516 μGy·m2 vs 52,100 μGy·m2, P = .053) but significantly longer procedure (160.1 min vs 137.1 min, P = .022) and fluoroscopy (62.9 min vs 46.1 min, P = .023) times. One major complication (urosepsis) occurred in each group (cPAE, 1/32 [3.1%]; nPAE, 1/80 [1.3%]). Both cases resolved after 2 weeks of intravenous antibiotics. A minor ischemic complication (1/32 [3.1%]) occurred in a patient with coil embolization, which manifested as white discoloration of the glans penis and resolved with topical therapy. There were no statistically significant differences in major and minor complications between cohorts at 1-month and 3-month follow-up visits. CONCLUSIONS Although coil embolization leads to increases in procedure and fluoroscopy times, it is a safe adjunctive technique to occlude communications between the prostatic artery and pelvic vasculature to potentially prevent nontarget embolization.


CardioVascular and Interventional Radiology | 2017

Anatomical Variants in Prostate Artery Embolization: A Pictorial Essay

Francisco Cesar Carnevale; Guilherme Rebello Soares; André Moreira de Assis; Airton Mota Moreira; Sardis Honoria Harward; Giovanni Guido Cerri

Prostate artery embolization (PAE) has emerged as a new treatment option for patients with symptomatic benign prostatic hyperplasia. The main challenges related to this procedure are navigating arteries with atherosclerosis and anatomical variations, and the potential risk of non-target embolization to pelvic structures due to the presence of collateral shunts and reflux of microparticles. Knowledge of classical vascular anatomy and the most common variations is essential for safe embolization, good clinical practice, and optimal outcomes. The aim of this pictorial essay is to illustrate the pelvic vascular anatomy relevant to PAE in order to provide a practical guide that includes the most common anatomical variants as well as to discuss the technical details related to each.


Globalization and Health | 2015

Design, testing, and scale-up of medical devices for global health: negative pressure wound therapy and non-surgical male circumcision in Rwanda

Gita N. Mody; Vincent Mutabazi; Danielle R. Zurovcik; Jean Paul Bitega; Sabin Nsanzimana; Sardis Honoria Harward; Claire M. Wagner; Cameron T Nutt; Agnes Binagwaho

Products with high efficacy and low cost are desirable in all market sectors and environments, particularly in settings where resources are limited. The health sectors of developing nations are an example of this basic economic principle as constrained financial and human resources must be budgeted toward large (and often, growing) populations’ health needs. However, the cost and quality characteristics that are absolutely necessary in resource-limited settings (RLS) remain highly desirable in wealthy markets as well. Consequently, technologies and strategies designed in RLS are frequently adopted by high-income nations, a process termed “reverse innovation” [1-4]. In recent years, some medical and surgical devices designed for RLS have been adopted by high-income nations. These reverse innovations have simultaneously overcome historical barriers to medical device deployment in RLS and challenged previously held assumptions regarding the direction of information transfer between high- and low-income nations. The potential for reverse innovation has subsequently been proposed as a reason in and of itself to develop products for RLS [4]. Products that result in reverse innovation offer improved care quality and treatment outcomes at lower costs to health care systems, expand markets for manufacturers, promote bidirectional transfer of information, and strengthen global partnerships for health equity [1-4]. One country that has made investments in myriad health innovations is Rwanda, a landlocked East African nation of approximately 12 million. Within the past two decades, Rwanda’s limited resources and diverse health care needs have combined to produce health care innovations ranging from community-based service delivery pathways to novel vaccine roll-out strategies [5-10]. Rwanda’s innovative approaches to seemingly insurmountable health challenges, and the nation’s resounding successes in these initiatives, have been described in a previous article in this Globalization and Health special series [2]. In the present article, we describe our experience with medical device innovation in Rwanda through two case studies, highlighting approaches taken to accelerate development and facilitate bidirectional flow of information. We also discuss ongoing challenges to progress in the field of health technology innovation for RLS. In sharing our experiences, we add our voices to the call for health technology innovation for low- and middle-income countries (LMICs).


CardioVascular and Interventional Radiology | 2017

Prostatic Tissue Elimination After Prostatic Artery Embolization (PAE): A Report of Three Cases

Leandro Cardarelli Leite; André Moreira de Assis; Airton Mota Moreira; Sardis Honoria Harward; Alberto A. Antunes; Francisco Cesar Carnevale

PurposeWe report three cases of spontaneous prostatic tissue elimination through the urethra while voiding following technically successful prostatic artery embolization (PAE) as a treatment for lower urinary tract symptoms (LUTS) related to benign prostatic hyperplasia (BPH).MethodsAll patients were embolized with 100- to 300-μm microspheres alone or in combination with 300- to 500-μm microspheres.ResultsDuring follow-up prior to eliminating the tissue fragments, the three patients all presented with intermittent periods of LUTS improvement and aggravation. After expelling the prostatic tissue between 1 and 5 months of follow-up, significant improvements in LUTS and urodynamic parameters were observed in all patients.ConclusionsUrethral obstruction after PAE caused by sloughing prostate tissue is a potential complication of the procedure and should be considered in patients with recurrent LUTS in order to avoid inappropriate management.


Canadian Association of Radiologists Journal-journal De L Association Canadienne Des Radiologistes | 2018

Rare Prostatic Artery Origins and the Importance of Collateral Circulation in Prostate Artery Embolization: A Pictorial Essay

Shivank Bhatia; Vishal K. Sinha; Osama Abdul-Rahim; Sardis Honoria Harward; Govindarajan Narayanan

The variability of pelvic arterial anatomy has led to anatomic descriptions based on cadaveric specimens, computed tomography (CT) angiography, and digital subtraction angiography (DSA) [1e3]. This has been especially relevant in prostate artery embolization (PAE), an emerging therapy for lower urinary tract symptoms (LUTS) in men with benign prostatic hyperplasia (BPH) [4e8]. In certain patients, PAE has served as a minimally invasive alternative to more standard surgical options, such as transurethral resection of prostate (TURP) and open prostatectomy. PAE offers a more preferable safety profile with minimal adverse effects, such as a decreased risk of sexual dysfunction when compared to TURP [4]. Although the indications for PAE have not been uniformly standardized, it has been offered for patients with medication-refractory severe LUTS [4e6], with prostates 80 g in which surgery carries perioperative risk [7], with chronic urinary retention [8], or with refractory hematuria of prostatic origin [9]. Contraindications to PAE vary among institutions, but include neurogenic bladder disease and active urinary tract infection [10]. The procedure is performed via transfemoral or transradial access to cannulate the PA and perform bland embolization. Thus, familiarity with variable PA anatomy is


Journal of Vascular and Interventional Radiology | 2018

Prostate Artery Embolization in Patients with Prostate Volumes of 80 mL or More: A Single-Institution Retrospective Experience of 93 Patients

Shivank Bhatia; Vishal K. Sinha; Sardis Honoria Harward; Christopher Gomez; Bruce R. Kava; Dipen J. Parekh

PURPOSE To evaluate the safety and efficacy of prostate artery embolization (PAE) for the treatment of benign prostatic hyperplasia for prostates ≥ 80 mL. PATIENTS AND METHODS A retrospective review was conducted of 93 patients with prostate volumes (PVs) ≥ 80 mL treated with PAE from April 2014 through October 2017. Mean patient age was 68.5 years (range 52-88) and mean age-adjusted Charlson comorbidity index was 3.2 (range 1-8). Exclusion criteria included history of biopsy-proven prostate cancer or catheter dependency. Clinical and urodynamic outcomes were reviewed at 1, 3, 6, and 12 months. Adverse events were graded according to the Clavien-Dindo classification. RESULTS Mean PV decreased significantly from 141.7 mL to 98.1 mL at 3 months (P < .01) and 82.2 mL at 12 months (P < .01). Significant improvements were seen in 3- and 12-month mean International Prostate Symptom Scores (IPSS) (22.3 vs 7.1 and 7.3, respectively; P < .01 for both), quality of life (QOL) (4.4 vs 1.2 and 1.3; P < .01 for both), and postvoid residual volume (196.7mL vs 92.1 and 61.2 mL; P < .01 and P < .01, respectively). Significant improvement was also seen in 3-month mean maximum urinary flow: 7.7 mL/s vs 12.8 mL/s (P < .01). One grade II complication of stroke occurred; all other complications were self-limited and grade I. CONCLUSIONS PAE achieved a clinically and statistically significant improvement in symptom burden and secondary outcome measures in patients with PVs ≥ 80 mL. PAE may be an alternate treatment for patients for whom conventional surgical options are limited or associated with significant morbidity.


Journal of Vascular and Interventional Radiology | 2018

Efficacy of Prostatic Artery Embolization for Catheter-Dependent Patients with Large Prostate Sizes and High Comorbidity Scores

Shivank Bhatia; Vishal K. Sinha; Bruce R. Kava; Christopher Gomez; Sardis Honoria Harward; Sanoj Punnen; I. Kably; Jeffrey Miller; Dipen J. Parekh

PURPOSE To evaluate efficacy and safety of prostate artery embolization (PAE) in urinary catheter-dependent patients with large prostate volumes and high comorbidity scores. MATERIALS AND METHODS A retrospective single-center review was conducted of 30 patients with urinary retention at time of PAE from November 2014 through February 2017. Mean (range) age was 73.1 years (48-94 y), age-adjusted Charlson comorbidity index was 4.5 (0-10), duration of urinary retention was 63.4 days (2-224 d), International Prostate Symptom Score quality-of-life (IPSS-QOL) was 5.3 (3-6), and prostate volume was 167.3 cm3 (55-557 cm3). These parameters were collected at 3, 6, and 12 months after PAE. Trials of voiding were performed approximately 2 weeks after PAE and, if failed, every 2 weeks thereafter. Adverse events were graded using the Clavien-Dindo classification. RESULTS At a mean (range) of 18.2 days (1-72 d), 26 (86.7%) patients were no longer reliant on catheters. Follow-up was obtained in all patients eligible at 3 and 6 months and 17 of 20 (85.0%) patients eligible at 1 year. Mean (range) IPSS-QOL improved significantly to 1.2 (0-5), 0.7 (0-4), and 0.6 (0-4) at 3, 6, and 12 months (all P < .001). Mean (range) prostate volume decreased significantly to 115.9 cm3 (27-248 cm3) at 3 months (P < .001). Two patients experienced grade II urosepsis complications, which were successfully treated with intravenous antibiotics. All other complications were self-limited grade I complications. CONCLUSIONS PAE represents a safe and effective option for management of patients with urinary retention, especially patients with large prostates who are not ideal surgical candidates.


CardioVascular and Interventional Radiology | 2015

Pelvic Arterial Anatomy Relevant to Prostatic Artery Embolisation and Proposal for Angiographic Classification

André Moreira de Assis; Airton Mota Moreira; Vanessa Cristina de Paula Rodrigues; Sardis Honoria Harward; Alberto A. Antunes; Miguel Srougi; Francisco Cesar Carnevale

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