Primary Effectiveness Endpoint Research Articles

A Multicenter, Objective Performance Criteria–Controlled Study for U.S. Food and Drug Administration Approval of the Minerva Endometrial Ablation System [142

INTRODUCTION: The primary objectives were to assess the safety and efficacy of the Minerva procedure compared with an objective performance criteria. Secondary objectives included amenorrhea rate, procedure time, anesthesia type, patient satisfaction, quality of life, and other. METHODS: This study, performed at seven centers in Canada, Hungary, and Mexico, was conducted for U.S. Food and Drug Administration (FDA) approval. A total of 105 premenopausal patients with menorrhagia (Pictorial Blood Loss Assessment Chart score of 150 or higher) underwent the Minerva endometrial ablation procedure. The primary effectiveness endpoint was bleeding at 12 months posttreatment with success defined as a Pictorial Blood Loss Assessment Chart score of less than 75 per cycle. Objective Performance Criteria was assigned by the FDA and composed of the success rates from the FDA clinical studies for the five FDA-approved endometrial ablation systems. RESULTS: At 12 months follow-up, data were available for all patients. Success rate (Pictorial Blood Loss Assessment Chart score less than 75) of the Minerva procedure was 97%, which is statistically significantly superior to the objective performance criteria success rate of 83%. Seventy percent of patients reported amenorrhea (Pictorial Blood Loss Assessment Chart score 0). The safety profile of the device or procedure was unremarkable. At 12 months of follow-up, 97.6% of patients were satisfied and 98.8% would recommend the procedure. Procedure time (device insertion to removal) was 3.8 minutes. Local±intravenous sedation was used in 83% of patients. No patients underwent hysterectomy or any other additional medical or surgical intervention for menorrhagia. CONCLUSION: Results of this multicenter, objective performance criteria–controlled FDA study indicate that Minerva endometrial ablation produces high rates of amenorrhea, success, and patient satisfaction. At 12 months of follow-up, the success rate of the Minerva procedure was statistically significantly superior to the objective performance criteria with avoidance of reintervention being 100%.

A prospective, observational grouped analysis to evaluate the effect of triptorelin on lower urinary tract symptoms in patients with advanced prostate cancer.

Few studies have assessed the effect of gonadotropin-releasing hormone (GnRH) agonists, such as triptorelin, on lower urinary tract symptoms (LUTS) in patients with advanced prostate cancer. Therefore, multiple, national observational, noninterventional studies were initiated to assess the effectiveness of triptorelin in reducing moderate or severe LUTS [International Prostate Symptom Score (IPSS) >7] in men with prostate cancer starting triptorelin therapy in clinical practice. Prospective, noninterventional, multicentre studies of LUTS located in Algeria, Belgium, China, Hungary, Romania and South Korea, in patients who were scheduled to receive triptorelin (3-month extended release or 1-month formulation) in clinical practice. The primary effectiveness endpoint was the proportion of patients with moderate or severe LUTS after 48 weeks as assessed by IPSS. Secondary endpoints included the distribution of IPSS categories, total IPSS and prostate-specific antigen (PSA) levels at baseline, 24 and 48 weeks. In total, 2461 patients were recruited in the studies; 1282 patients had moderate or severe LUTS at baseline (IPSS > 7), received triptorelin and had follow-up IPSS. Mean total IPSS was reduced from 18.2 [95% confidence interval (CI) 17.8-18.5] at baseline to 11.9 (95% CI 11.5-12.3; p < 0.001) and 10.6 (95% CI 10.2-11.0; p < 0.001) at weeks 24 and 48, respectively. Mean PSA levels were reduced from 117.9 ng/ml (95% CI 93.8-141.9) at baseline to 8.5 ng/ml (95% CI 5.2-11.7) and 16.6 ng/ml (95% CI 7.4-25.8) at weeks 24 and 48, respectively. There was a significant correlation between total IPSS change from baseline and PSA change from baseline at weeks 24 and 48 (ρ = 0.3 and 0.2, p < 0.001). The improvement in LUTS in men with locally advanced or metastatic prostate cancer after 24-48 weeks suggests that triptorelin is effective in improving LUTS in this subgroup of patients.

A Randomized Open Comparative Clinical Trial on the Effectiveness, Safety and Tolerability of a Homeopathic Medicinal Product for the Treatment of Painful Teething in Children

Background: Homeopathic products are sold over the counter and are often used for treatment of self-limiting complaints in children such as painful teething. Objective: To investigate the effectiveness, safety and tolerability of the homeopathic product ChamBell-5-02, in the treatment of children with painful teething in comparison to another homeopathic product. Design: A multicenter, randomized, open, comparative clinical trial with two parallel treatment groups at three outpatient pediatric clinics in Russia. Methods: Children aged ≤ six years with painful teething were enrolled from March-July 2009 in the study and randomized to receive either ChamBell-5-02 tablets (Dentokind®; intervention group) or homeopathic suppositories (Viburcol®; control group). Exclusion criteria were: fever of ≥38°C and severe comorbidity. Primary effectiveness endpoints were change of total severity scores of subjective complaints (TSSC) and clinical signs (TSCS) rated by investigators after seven days of treatment. Treatment satisfaction and safety (via number of adverse events (AEs)) were assessed. Results: A total of 200 children (100 per group) were included and analyzed. TSSC/ TSCS decreased after the 7- day treatment period from median 7.0 to 1.0/6.0 to 1.0 points in the intervention group and from median 5.0 to 1.0/5.5 to 1.0 points in the control group. Compared to the control group children receiving ChamBell-5-02 had about five/2.5 time higher odds of showing improvement (TSSC/TSCS: odds ratio resulting from proportional odds model was 5.1 (95%-CI: 2.7-9.4, p<0.0001) / 2.5 (95%-CI: 1.5-4.4, p=0.0011). Furthermore the intervention group showed a more favorable outcome regarding treatment satisfaction (ratings very satisfied: intervention group: n=94; control group: n=58). No AEs were recorded in the intervention group. In the control group three mild to moderate, nonserious AEs occurred. Conclusions: Overall it can be concluded that in this study ChamBell-5-02 tablets showed to be effective, safe and well tolerated.

A new dermal filler made of cross-linked and auto-cross-linked hyaluronic acid in the correction of facial aging defects.

A novel Hyaluronic Acid (HA) derivative dermal filler has been developed with characteristics especially suited for nasolabial folds (NLF) and facial defects due to volume loss. An open-label prospective study was carried out to evaluate this HA filler's performance in correcting facial defects due to volume loss. A single Italian site treated subjects aged 30-65 for facial defects due to volume loss with a new dermal filler injectable gel; subjects returned to the clinic at 7 and 14 days, and 1, 3, 6, 9, and 12 months for follow-up. The primary effectiveness endpoint was improvement in wrinkle severity (measured using the Wrinkle Severity Rating Scale) (WSRS) and facial volume (measured using the Facial Volume Loss Scale) (FVLS) at 6 and 12 months from baseline. Secondary endpoints were safety evaluation, performance duration, product handling, subjects' and investigator's treatment evaluation. Assessment of aesthetic results included the skin hydration, image analysis of nasolabial folds (3D), and photographic documentation. The reduction in nasolabial wrinkles was statistically significant at 6 months after the first implant. The aesthetic improvement of 1 grade on WSRS was evident in 95% of subjects up to 3 months, in 84% of subjects up to 6 months and in 27% up to 12 months. A clinically (> 1 point improvement) and statistically significant improvement in the FVLS was observed at each study visit; in 100% of treated cases, up to 3 months and in 61% up to 9 months. Good results were obtained during the study in skin hydration. There were no severe adverse events related to treatment. This injectable gel is well tolerated and has been demonstrated to provide a smooth and natural improvement in facial defects due to volume loss in nasolabial folds and the malar region that lasts for up to 1 year.

Early sheath removal after percutaneous coronary intervention using Assiut Femoral Compression Device is feasible and safe. Results of a randomized controlled trial

Abstract Objective This study was performed to evaluate the feasibility and safety of early sheath removal after percutaneous coronary intervention (PCI) using a locally designed Assiut Femoral Compression Device (AFCD2) vs. manual compression (MC). Background Due to antithrombotic therapy before, during, and after PCI, the arterial femoral sheath is generally not removed early after PCI. Patients and methods This was a randomized, controlled trial. We enrolled all patients undergoing PCI at Assiut University Hospitals from September, 2013 to December, 2013. At the end of PCI, the arterial hemostasis method was randomly assigned 1:1 to AFCD2 vs. MC. The sheaths were removed 2 h after PCI, instead of conventional 6 h, in the AFCD2 arm. Results The trial assigned 100 patients (mean age 57 ± 9 years, 75% men) to AFCD2 (n = 50) vs. MC (n = 50). Both groups were comparable regarding baseline characteristics. Concerning the primary effectiveness end point, there was significantly shorter mean time-to-ambulation with AFCD2 (8.2 ± 1.42 h) vs. MC (12.02 ± 0.22 h; p = Conclusion Our results indicate that AFCD2 is a simple and effective alternative to MC for hemostasis following PCI. Early sheath removal 2 h post PCI is feasible, safe, and improves the patient’s comfort.

A new femoral compression device compared with manual compression for bleeding control after coronary diagnostic catheterizations

This study was performed to evaluate the safety and efficacy of a locally designed assiut femoral compression device (AFCD) versus manual compression (MC). Femoral compression devices have been developed thorough the past decades without being strongly implemented in the catheterization laboratory. Their limited adoption reflects concerns of high cost and conflicting data regarding their safety. This was a prospective study. We enrolled 206 consecutive patients undergoing diagnostic coronary angiography From July, 2012 to April, 2013. They were divided into two groups: 100 patients used AFCD and 106 patients used MC for arterial hemostasis. Both groups were comparable regarding baseline characteristics. Concerning the primary effectiveness end point, there was no difference in the mean time-to-hemostasis with AFCD (12.5 ± 3 min) vs. MC (13 ± 2 min, p = 0.4). As regards safety, none of our research population experienced major adverse events. No complication was new or unanticipated, and the type of complication did not differ between the two groups. The incidence of vagal episodes were comparable between both groups (3 patients (3%) in AFCD vs. 2 patients in MC (1.8%); p = 0.2). The use of AFCD was associated with similar occurrence of minor complications, mainly ecchymosis and oozing, compared with MC (27% vs. 27.4%, p = 0.8). Large hematoma >5 cm was noted only in 1 patients (1%) in the AFCD arm vs. 2 patients (1.8%) in the MC arm (p = 0.8). Our results indicate that AFCD is a simple, safe and effective alternative to MC for hemostasis following diagnostic coronary angiography.

Nonrandomized Prospective Study of an Upper Esophageal Sphincter (UES) Assist Device for Treating Laryngopharyngeal Reflux

Objectives: (1) Describe treatment of the heterogeneous disorder of laryngopharyngeal reflux (LPR) with a new upper esophageal sphincter (UES) assist medical device designed to eliminate the reflux of gastric contents into the laryngopharynx. (2) Analyze the reduction of symptoms pre-therapy compared to posttherapy. Methods: Patients presenting with a reflux symptoms index (RSI) &gt;13 and diagnosed with chronic cough, postnasal drip, globus, or throat clearing were included in the study. The UES assist device was fitted individually to apply external pressure above 20 mm Hg at the cricoid and worn when sleeping. The primary effectiveness endpoint was reduction of the RSI at 4 weeks. SF-36 Health Survey, Functional Outcomes of Sleep Questionnaire (FOSQ), and patient and physician satisfaction scores were secondary end points. Intent to treat (ITT) analysis was performed. Safety was based on reported adverse reactions. Results: Forty-four patients consented, with 42 (ITT) completing the study (age, 47 ± 13.1 years; body mass index, 24.8 ± 3.5; 66% female; 75% Caucasian). Most troublesome symptoms were post nasal drip, throat clearing, and annoying cough. Adverse events were mild and short in duration with no study withdrawals due to an adverse event. There was a significant ( P &lt; .0001) reduction of the RSI at 2 weeks (13.2 ± 8.8) and 4 weeks (10.2 ± 7.6) posttherapy compared with pretherapy (24.5 ± 5.9). Ninety-one percent of patients improved at least 25% with 33% improving at least 75%. Conclusions: The UES assist device is a safe and effective noninvasive method for the treatment of LPR and provides clinical utility within 2 weeks. This could be a potential alternative for LPR before considering medications or surgery.

Rationale and design of the Pan Australasian chemotherapy-induced emesis burden of illness study.

Preventing and managing chemotherapy-induced nausea and vomiting (CINV) remain important goals. The objective of the Pan Australasian chemotherapy-induced emesis burden of illness (PrACTICE) study was to describe the incidence of CINV after highly or moderately emetogenic chemotherapy (HEC or MEC) for cancer in current clinical practice in Australia and five Asian countries (China, India, Singapore, South Korea, and Taiwan). This prospective, observational study of CINV was conducted at 31 sites in these six countries from August 2011 through September 2012 and enrolled male and female adult patients (≥18 years of age) naïve to HEC and MEC who were scheduled to receive at least two cycles of single-day chemotherapy. The primary effectiveness endpoint was complete response, defined as no vomiting or use of rescue therapy, during chemotherapy cycle 1 in the overall phase (0-120 h), acute phase (0-24 h), and delayed phase (>24-120 h). Study outcomes were analyzed descriptively. Primary outcomes, CINV incidence, and treatment patterns (chemotherapy, CINV prophylaxis, rescue medication prescription, and rescue medication use) were assessed by phase (overall, acute, delayed), by cycle (as appropriate), within and across countries, and by level of chemotherapy emetogenicity (HEC vs. MEC). The impact of CINV in cycle 1 on CINV in cycle 2 was analyzed for all patients with evaluable data for cycle 2. No site-specific analyses were performed. The remainder of this special series of papers reports on the results of this study.

Outcome of the pivotal study of the Aptus endovascular abdominal aortic aneurysms repair system

Endovascular treatment of abdominal aortic aneurysm (AAA) is associated with benefits over open surgery, yet limitations remain with current endovascular devices. This study was performed to assess outcomes of AAA repair with the Aptus endograft and EndoAnchors (Aptus Endosystems, Sunnyvale, Calif). This prospective, multicenter, single-arm investigational device exemption trial was conducted at 25 sites in the United States. A total of 155 patients were enrolled in the trial (mean age, 73 ± 8 years; male, 93.5%; mean AAA diameter, 53.6 ± 7.9 mm). The Aptus endograft is a two-component system: a multilumen, modular endograft with two docking limbs (Aptus Endograft System) and the Heli-FX Aortic Securement System comprising an electronically controlled applier (Heli-FX Applier) with helical EndoAnchors provided in a cassette and a deflectable sheath (Heli-FX Guide) designed for delivery of the applier to the target location for EndoAnchor implantation. The main eligibility criteria included proximal neck length of ≥12 mm, diameter of 19 to 29 mm, and infrarenal angulation of ≤60 degrees. The primary safety end point was freedom from major adverse events at 30 days, and the primary effectiveness end point was successful aneurysm treatment at 12 months. Thrombus-related events (TRE) were defined as limb occlusion or thromboembolism from the endograft. Subjects were observed for a median of 4.2 years, with imaging end points analyzed by a core laboratory and adverse events adjudicated by a clinical events committee. Among 155 enrolled subjects, 153 (98.7%) underwent successful implantation of the Aptus endograft and a median of five EndoAnchors; two subjects were converted to open surgical repair during the initial procedure. Overall, the primary safety and effectiveness end points were met in 98.1% and 97.4% of the subjects, respectively. Aneurysm-related mortality was 0.6%, with one postdischarge cardiac death 18 days after implantation. There were no AAA ruptures. There were no fractures of stents or EndoAnchors. There was one type I endoleak and one type III endoleak. Stent graft migration was noted in five subjects, none associated with sac enlargement, type I endoleak, or EndoAnchor dislocation from the endograft. AAA sac shrinkage of ≥5 mm at 1, 2, and 3 years was observed in 60.3%, 72.9%, and 81.7%, respectively. Sixty-one subjects (39.4%) experienced 113 TRE, associated with 80 reinterventions (in 58 subjects) unassociated with limb loss or death. A root cause analysis of TRE identified small, out-of-specification docking limbs with graft infolding and high local shear, resulting in thrombus formation within the endograft with subsequent distal embolization in some cases. Early results of the Aptus endograft trial met its safety and effectiveness end points; however, a high rate of TRE was observed because of manufacturing discrepancies. The findings confirm a low rate of type I and type III endoleaks, migration, and non-TRE reintervention with a high rate of aneurysm sac regression during midterm follow-up.

Safety and effectiveness of the INCRAFT AAA Stent Graft for endovascular repair of abdominal aortic aneurysms

This study evaluated the 2-year safety and effectiveness of the European First-in-Human INNOVATION trial for the INCRAFT AAA Stent Graft system (Cordis Corp, Bridgewater, NJ), an ultra-low-profile device for the treatment of abdominal aortic aneurysms. From March 2010 to June 2011, the INNOVATION prospective multicenter trial involving six centers in Europe enrolled and treated 60 asymptomatic patients (95% male; mean age, 74.4 ± 6.9 years) with the INCRAFT System. Main inclusion criteria included proximal aortic neck length of 15 mm or more with a diameter up to 27 mm; distal iliac landing zones with a length greater than 10 mm and a diameter between 9 and 18 mm; and aortic bifurcation >18 mm in diameter and access vessels large enough to accept the 14F outer diameter of the delivery system. The primary end point was technical success at 1 month; 2-year safety end points included the absence of device- or procedure-related major adverse events, absence of type I or III endoleaks, and maintenance of device integrity through 2 years of follow-up. Study oversight was provided by a Data Safety Monitoring Board with event adjudication by a Clinical Events Committee and imaging analysis by an independent core laboratory. Of 60 successfully treated patients, two did not come back for their 1-month evaluation but remained enrolled in the study; 56 were evaluated at 1 year and 52 at 2 years. Of the 58 patients, 56 met the 1-month primary safety and effectiveness end point (97%; 95% confidence interval, 88%-100%). All patients were free from aneurysm enlargement through 2 years. There were no type I or III endoleaks at the 2-year time point. All-cause mortality at 2 years was 11.5%, and no death was device or procedure related. In total, three patients required a postprocedure intervention, two to repair a type I endoleak and one for limb occlusion. Core laboratory evaluation of the postoperative imaging studies documented absence of endograft migration and stent fractures in all patients. The INCRAFT AAA Stent Graft System provides a durable solution for patients with abdominal aortic aneurysms, with a low frequency of device-related events through 2 years of follow-up.

725 A Multi-Center Prospective Study of the Upper Esophageal Sphincter (UES) Assist Device for the Treatment of Extraesophageal Reflux

Background: Extra-esophageal reflux (EER) is a heterogeneous disorder,caused by reflux of gastroduodenal contents resulting in symptoms such as chronic cough, hoarseness, throat clearing and globus. The cost of caring for EER exceeds $50 billion due predominately to over utilization of proton pump inhibitors (PPI's) which are often not effective. The Upper Esophageal Sphincter (UES) Assist Device is a novel medical device designed to eliminate the reflux of gastric contents into the laryngopharynx. In this multicenter prospective study we aimed to assess efficacy and safety of this device in patients with suspected EER. Methods: Patients with extraesophageal presentations and reflux symptom index (RSI) > 13 were invited to participate in this multicenter study. Predominant presenting symptoms included chronic cough, choking, aspiration, chronic post nasal drip, globus, sore throat, throat clearing. The UES assist device, worn at bed-time, was fitted individually and a deviceapplied external cricoid pressure adjusted to above 20 mmHg. Applied cricoid pressure was monitored by external sensors in all subjects to ensure readings above 20 mmHg for study duration. RSI, SF-36, patient and physician satisfaction scores and Functional Outcomes of Sleep Questionnaire (FOSQ) were measured at 2and 4-weeks post enrollment. The study primary effectiveness endpoint was reduction in RSI at 4-weeks from baseline. Intend to treat (ITT) analysis conducted post intervention. Safety was based on reported adverse reactions. Results: 51 patients consented and 47 patients (ITT) completed study protocol in four centers [mean (SD) age=50 (+/-14.2); median (IQR) BMI= 25.8 (23-29); 72% female, 86% Caucasian]. Most common troublesome symptoms included chronic cough (28%), excess mucus/post nasal drip (19%), throat clearing (11%) and hoarseness (11%). There was a significant (p< 0.0001) reduction in median (IQR) RSI at 2and 4-weeks post therapy [14.0 (8.0-20) and 12.0 (7.0-19), respectively] compared to pre-therapy values (27 (21-32) (Figure). Eighty-six percent (86%) of patients reported improvement greater than 25%, The mean (+/-SD) improvement from baseline was 54% (+/-28.1%) with 30% of patients having an improvement of 75% or more. SF36 and FOSQ were unchanged; however, 75% of patients and 92% of providers reported satisfaction with the device. The adverse events reported during the course of the study were generally mild [device technical issues 14% and mild skin irritation (8%)] and there were no study withdrawal due to adverse events. Conclusion: The UES assist device is a safe and effective non-invasive method for the treatment of extraesophageal symptoms. Given poor response to PPI therapy in many such patients this device by serve as a potential alternative for this difficult to treat group of patients.

Design characteristics of the CORRONA CERTAIN study: a comparative effectiveness study of biologic agents for rheumatoid arthritis patients

BackgroundComparative effectiveness research has recently attracted considerable attention. The Comparative Effectiveness Registry to study Therapies for Arthritis and Inflammatory Conditions (CERTAIN) is an ongoing prospective cohort study of adult patients with Rheumatoid Arthritis (RA).Methods/DesignCERTAIN uses the existing Consortium of Rheumatology Researchers of North America (CORRONA) network of participating private and academic sites in order to recruit patients fulfilling the 1987 ACR criteria that have at least moderate disease activity. Patients starting or switching biologic agents either anti-TNF therapy or a non anti-TNF biologic are eligible for enrollment, depending on the treatment selected by their physician. Enrollment is expected to be completed by March of 2014, and 2711 patients will participate in the study. As of October 7th 2013, 2234 patients have been enrolled. Patient visits and laboratory blood work are mandated every three months for one year. Safety data is collected through one year and beyond. The primary comparative effectiveness endpoint is attainment of low RA disease activity at one year among patients who have been exposed to at least one prior TNF-α inhibitor agent prior to enrollment. Multiple secondary effectiveness and safety endpoints will be addressed by investigating the entire population enrolled (naïve and biologic experienced).DiscussionThe unique design features of CERTAIN will inform comparative effectiveness and safety questions for choosing biologic agents for the management of RA.

Effectiveness and tolerability of second-line therapy with vildagliptin versus other oral agents in type 2 diabetes (EDGE): post-hoc subanalysis of the Belgian data

Aim:To assess the efficacy and safety of vildagliptin versus other oral glucose-lowering drugs added to antidiabetic monotherapy in Belgian patients with type 2 diabetes mellitus, in comparison to the global EDGE study results.Methods:This is a pre-specified post-hoc subanalysis of the Belgian patient cohort from a worldwide 1-year observational study that compared the effectiveness and tolerability of vildagliptin to other oral antidiabetic agents in type 2 diabetes patients failing monotherapy with oral glucose-lowering agents (EDGE). A total of 1793 Belgian patients were enrolled. Physicians could add any oral antidiabetic drug and patients entered either into the vildagliptin or the comparator cohort. The primary effectiveness and tolerability endpoint was defined as the proportion of patients having a treatment response (HbA1c reduction from baseline to month 12 endpoint >0·3%) without hypoglycemia, weight gain, peripheral oedema, or gastrointestinal side-effects.Results:In the Belgian population, 37·8% of patients in the vildagliptin group and 32·8% in the comparator group had a decrease in HbA1c of >0·3% without the predefined tolerability issues of hypoglycemia, weight gain, oedema or, gastrointestinal complaints (primary endpoint), resulting in an unadjusted odds ratio of 1·24 (95% CI: 0·96–1·61). Mean HbA1c change from baseline was −0·81% in the vildagliptin cohort and −0·75% in the comparator cohort. Overall, vildagliptin was well tolerated with similarly low incidences of total adverse events (14·9% versus 14·5% in the compactor group) and serious adverse events (2·7% versus 2·5% in the comparator group).Conclusion:In this EDGE subgroup of Belgian patients with type 2 diabetes who do not achieve the glycemic targets with monotherapy, a similar trend as in the global EDGE study was observed. Adding vildagliptin as a second oral glucose-lowering agent resulted in lowering HbA1c to <7% without weight gain, hypoglycemia or peripheral oedema in a higher proportion of patients than comparator oral antidiabetic drugs, with no differences in the reported number of adverse events.

Select Articles Published on the Topic of Arrhythmia and Electrophysiogy in 2013

Select Articles Published on the Topic of Arrhythmia and Electrophysiogy in 2013

Is the sham procedure 'toxic' for renal denervation?

The announcement by Medtronic that the SYMPLICITY HTN-3 trial failed to meet its primary effectiveness end point calls the blood pressure lowering effects of renal denervation into question. However, its safety is proven, which raises the possibility that the procedure might have beneficial effects on the kidneys beyond blood pressure reduction.

Catheter-based radiofrequency renal sympathetic denervation for resistant hypertension: initial Egyptian experience

To evaluate the feasibility, efficacy, and safety of catheter-based radiofrequency renal sympathetic denervation for treatment of resistant hypertension. In a subpopulation of patients with essential hypertension, therapeutic targets are not met, despite the use of multiple types of medication. In this paper we describe our first experience with a novel percutaneous treatment modality using renal artery radiofrequency (RF) ablation. Thirty patients with essential hypertension unresponsive to at least three types of antihypertensive medical therapy (baseline office systolic blood pressure ⩾160 mmHg) were selected between March and September 2012 and received percutaneous RF ablation. Patients were followed up for 6 months after treatment. The primary effectiveness endpoint was change in seated office-based measurement of systolic blood pressure at 6 months. Another thirty patients were taken as control. A reduction of mean office blood pressure was seen from 170/102 ± 9/5 mmHg at baseline to 151/91 ± 8/6 mmHg at 6 months follow-up ( p = 0.001). Also, we noted a significant decrease in plasma renin activity (3.66 ± 0.64 versus 3.37 ± 0.47 ng/mL/h; p = 0.003). No periprocedural complications, adverse events or change in renal function were noted during follow-up. Catheter-based renal denervation seems an attractive minimally invasive treatment option in patients with resistant hypertension, with a low risk of serious adverse events.

Catheter-based radiofrequency renal sympathetic denervation for resistant hypertension; initial Egyptian experience

To evaluate the feasibility, efficacy, and safety of catheter-based radiofrequency renal sympathetic denervation for treatment of resistant hypertension. In a subpopulation of patients with essential hypertension, therapeutic targets are not met, despite the use of multiple types of medication. In this paper we describe our first experience with a novel percutaneous treatment modality using renal artery radiofrequency (RF) ablation. Thirty patients with essential hypertension unresponsive to at least three types of antihypertensive medical therapy (baseline office systolic blood pressure ⩾160 mmHg) were selected between March and September 2012 and received percutaneous RF ablation. Patients were followed up for 6 months after treatment. The primary effectiveness endpoint was change in seated office-based measurement of systolic blood pressure at 6 months. Another thirty patients were taken as control. A reduction of mean office blood pressure was seen from 170/102 ± 9/5 mmHg at baseline to 151/91 ± 8/6 mmHg at 6 months follow-up ( p = 0.001). Also, we noted a significant decrease in plasma renin activity (3.66 ± 0.64 versus 3.37 ± 0.47 ng/mL/h; p = 0.003). No periprocedural complications, adverse events or change in renal function were noted during follow-up. Catheter-based renal denervation seems an attractive minimally invasive treatment option in patients with resistant hypertension, with a low risk of serious adverse events.

Safety and effectiveness of a single-piece hydrophobic acrylic intraocular lens (enVista®) - results of a European and Asian-Pacific study.

PurposeTo evaluate the safety and effectiveness of a single-piece hydrophobic acrylic intraocular lens (IOL) (enVista® MX60; Bausch and Lomb Incorporated, Rochester, NY, USA) following implantation to correct aphakia subsequent to extracapsular cataract extraction in adults.Subjects and methodsThis was an open-label, non-interventional, observational study conducted in 19 university and private-practice settings in Europe and the Asia-Pacific region to investigate clinical outcomes of the MX60 IOL in standard practice. Eligible subjects were at least 18 years of age and had undergone standard phacoemulsification and extracapsular cataract extraction with implantation of the MX60 IOL. The primary safety endpoint was the occurrence of adverse events, and the primary effectiveness endpoints included visual and refractive outcomes and stability, with data collected up to 2 years post-procedure.ResultsIn this multicenter study, pooled data of 255 eyes were collected and analyzed. Excellent visual and refractive outcomes and stability were demonstrated. At postoperative visit 4 (61–180 days postoperative), 62.2% of subjects achieved a Snellen best-corrected distance visual acuity (CDVA) of 20/20 (decimal 1.00), and 97.8% of subjects achieved a CDVA of 20/40 (decimal 0.50) or better. One eye (1.0%) underwent neodymium:yttrium aluminum garnet capsulotomy at 12 months post-procedure. No glistenings of any grade were reported for any subject at any visit. Adverse events were infrequent and were consistent with incidences generally reported with cataract surgery.ConclusionThis study, which enrolled all comers, provided evidence of the excellent safety and effectiveness of the MX60 IOL in standard practice. Favorable clinical outcomes included outstanding visual and refractive outcomes and stability. No glistenings were reported at any postoperative visit.

Effective endovascular treatment of calcified femoropopliteal disease with directional atherectomy and distal embolic protection: Final results of the DEFINITIVE Ca++ trial

ObjectivesThe purpose of the DEFINITIVE Ca++ study was to evaluate the safety and effectiveness of directional atherectomy and distal embolic protection, used together to treat moderate to severely calcified femoropopliteal lesions.BackgroundDespite advances in endovascular treatment modalities, treatment of calcified lesions remains a challenge.MethodsA total of 133 subjects with 168 moderate to severely calcified lesions were enrolled. Lesions were treated with directional atherectomy devices, coupled with distal embolic protection.ResultsThe 30-day freedom from MAE rate was 93.1%. Per angiographic core laboratory assessment, the primary effectiveness endpoint (≤50% residual diameter stenosis) was achieved in 92.0% (lower confidence bound of 87.6%) of lesions. By core lab analysis, these results did not achieve the success criteria (90%) for the primary effectiveness objective. Per site assessment, the objective was met with the endpoint being achieved in 97.0% (lower confidence bound 93.8%). A mean residual diameter stenosis of 33.3% was achieved with the directional atherectomy device. This was further decreased to 24.1% with the use of adjunctive therapy. The proportion of asymptomatic subjects [Rutherford Clinical Category (RCC) = 0] increased from 0% at baseline to 52.3% at the 30-day follow-up visit. In total, 88.5% of subjects experienced an improvement of one or more Rutherford categories.ConclusionsThe results of the DEFINITIVE Ca++ study demonstrate that the SilverHawk™ and TurboHawk™ atherectomy devices are safe and effective in the endovascular treatment of moderate to severely calcified lesions in the superficial femoral and/or popliteal arteries when used with the SpiderFX™ distal embolic protection device. © 2014 Wiley Periodicals, Inc.

SYMPLICITY HTN-3 results to be announced: a mystery or a story foretold?

SYMPLICITY HTN-3 results to be announced: a mystery or a story foretold?