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Hopson S.B.,Bon Secours Hernia Center | Miller L.E.,Miller Scientific Consulting Inc.
International Journal of Surgery | Year: 2015

Purpose: Secure mesh fixation in incisional hernia repair is mandatory to prevent mesh dislocation and possible recurrence. Traditional fixation methods have been implicated as a source of chronic postoperative pain. We report 2-year outcomes with a self-gripping mesh for open tension-free repair of large incisional hernia. Methods: This prospective case series enrolled 20 patients with large primary incisional hernia (mean defect size: 84 cm2). Patients were electively treated by a single surgeon using a macroporous polyester mesh with resorbable polylactic acid microgrips (ProGrip™, Covidien, Mansfield, MA, USA) using open onlay technique. Main outcomes included pain severity, Carolinas Comfort Scale (CCS), complications, and hernia recurrence. Patients returned for follow-up at 1, 3, 6, 12, and 24 months. Results: Median mesh fixation time was 2 min. Mean operative time was 38 min and blood loss was minimal (50 cc). Most patients (75%) were discharged same day. The only perioperative complication was a minor seroma in one patient. Patient follow-up compliance through 2 years was 100%. Mean pain score was 1.8 at discharge, 0.9 at 1 month, 0.7 at 1 year, and 0 at 2 years. At 2-years, all patients were "very satisfied" with treatment and hernia-specific quality of life was excellent (mean CCS score = 0). No infection, mesh removal, or hernia recurrence occurred during follow-up. Conclusions: Open repair using a self-gripping mesh is a viable treatment option in patients with large incisional hernia. Immediate mesh fixation facilitates a safe and durable tension-free repair. © 2015 Elsevier Ltd.


Miller L.E.,Miller Scientific Consulting Inc. | Miller L.E.,Jon Block Group | Block J.E.,Jon Block Group
Spine | Year: 2011

Study Design: Systematic review. Objective: The primary aim of this review was to evaluate clinical and radiographic outcomes in studies of anterior cervical discectomy and fusion (ACDF) using allograft versus ACDF with autograft, ACDF with cage devices, and cervical disc arthroplasty for the treatment of symptomatic cervical disc disease. Summary of Background Data: ACDF remains the standard of care for patients with cervical radiculopathy who are unresponsive to conservative medical care. However, no known study has compared patient outcomes after ACDF with allograft, ACDF with autograft, ACDF with cage, and disc arthroplasty. Methods: After applying strict inclusion criteria, 21 comparisons from 20 studies formed the basis for this review. Patient outcomes included neck and arm pain, neck disability index (NDI), physical component summary (PCS), and mental component summary (MCS) scores from the SF-36, radiographic fusion rate, and select adverse events (e.g., wound infection, dysphagia, and adjacent segment degeneration). Results: The four treatment groups included ACDF with allograft (allograft, n = 1341), ACDF with autograft (autograft, n = 568), ACDF with cage (cage, n = 87), and cervical disc arthroplasty (arthroplasty, n = 603). Neck pain was reduced similarly by 63% to 69% in all groups. Comparable improvements were realized in arm pain after ACDF with allograft (75%) or arthroplasty (73%) that were greater than other treatment groups (62-68%). There was notable improvement in neck disability (61-65%) with allograft and arthroplasty after treatment. PCS scores improved with allograft (42%) and arthroplasty (44%). MCS scores improved modestly (16-21%) with allograft and arthroplasty. Fusion rates were 91% for allograft and autograft and 97% for cage. Adverse events were uncommon in all groups. Conclusion: ACDF with allograft, ACDF with autograft, ACDF with cage, and cervical disc arthroplasty show similar improvements in pain, function, and quality of life with correspondingly low adverse event rates. All ACDF procedures result in high fusion rates. © 2011 Lippincott Williams & Wilkins.


Razavi M.K.,Joseph Hospital | Jaff M.R.,Massachusetts General Hospital | Miller L.E.,Miller Scientific Consulting Inc.
Circulation: Cardiovascular Interventions | Year: 2015

Endovenous recanalization of iliofemoral stenosis or occlusion with angioplasty and stent placement has been increasingly used to maintain long-term venous patency in patients with iliofemoral venous outflow obstruction. The purpose of this systematic review and meta-analysis was to determine safety and effectiveness of venous stent placement in patients with iliofemoral venous outflow obstruction. Methods and Results-We searched MEDLINE and EMBASE for studies evaluating safety or effectiveness of stent placement in patients with iliofemoral venous outflow obstruction. Data were extracted by disease pathogenesis: nonthrombotic, acute thrombotic, or chronic post-thrombotic. Main outcomes included technical success, periprocedural complications, symptom relief at final follow-up, and primary/secondary patency through 5 years. A total of 37 studies reporting 45 treatment effects (nonthrombotic, 8; acute thrombotic, 19; and chronic post-thrombotic, 18) from 2869 patients (nonthrombotic, 1122; acute thrombotic, 629; and chronic post-thrombotic, 1118) were included. Technical success rates were comparable among groups, ranging from 94% to 96%. Complication rates ranged from 0.3% to 1.1% among groups for major bleeding, from 0.2% to 0.9% for pulmonary embolism, from 0.1% to 0.7% for periprocedural mortality, and from 1.0% to 6.8% for early thrombosis. Patient symptom relief data were reported inconsistently. At 1 year, primary and secondary patency were 96% and 99% for nonthrombotic, 87% and 89% for acute thrombotic, and 79% and 94% for chronic post-thrombotic. Conclusions-Stent placement for iliofemoral venous outflow obstruction results in high technical success and acceptable complication rates regardless of cause of obstruction. © 2015 American Heart Association, Inc.


Miller L.E.,Miller Scientific Consulting Inc. | Block J.E.,The Jon Block Group
Clinical Medicine Insights: Arthritis and Musculoskeletal Disorders | Year: 2013

We conducted a systematic review and meta-analysis of randomized saline-controlled trials to determine the safety and effcacy of US-approved intra-articular hyaluronic acid (IAHA) injections for symptomatic knee osteoarthritis. A total of 29 studies representing 4,866 unique subjects (IAHA: 2,673, saline: 2,193) were included. IAHA injection resulted in very large treatment effects between 4 and 26 weeks for knee pain and function compared to pre-injection values, with standardized mean difference (SMD) values ranging from 1.07-1.37 (all P< 0.001). Compared to saline controls, SMDs with IAHA ranged from 0.38-0.43 for knee pain and 0.32-0.34 for knee function (all P<0.001). There were no statistically significant differences between IAHA and saline controls for any safety outcome, including serious adverse events (SAEs) (P = 0.12), treatment-related SAEs (P = 1.0), study withdrawal (P = 1.0), and AE-related study withdrawal (P = 0.46). We conclude that intra-articular injection of US-approved HA products is safe and efficacious in patients with symptomatic knee osteoarthritis. © the author(s), publisher and licensee Libertas Academica Ltd.


Berkoff D.J.,University of North Carolina at Chapel Hill | Miller L.E.,Miller Scientific Consulting Inc. | Miller L.E.,The Jon Block Group | Block J.E.,The Jon Block Group
Clinical Interventions in Aging | Year: 2012

Intra-articular corticosteroid and hyaluronic acid injections provide short-term symptom amelioration for arthritic conditions involving structural damage or degenerative changes in the knee. Conventional palpation-guided anatomical injections frequently result in inaccurate needle placement into extra-articular tissue and adjacent structures. The purpose of this review was to determine the effect of ultrasound guidance on the accuracy of needle placement, clinical outcomes, and cost-effectiveness in comparison with anatomical landmarkguided intra-articular large joint injections, with particular emphasis on the knee. A total of 13 relevant studies were identified; five studied the knee, seven studied the shoulder, one used both the knee and shoulder, and none studied the hip. Ultrasound was used in seven studies; the remaining studies utilized air arthrography, fluoroscopy, magnetic resonance arthrography, or magnetic resonance imaging. Across all studies (using all imaging modalities and all joints), needle placement accuracy ranged from 63% to 100% with ultrasound and from 39% to 100% with conventional anatomical guidance. Imaging guidance improved the accuracy of intraarticular injections of the knee (96.7% versus 81.0%, P < 0.001) and shoulder (97.3% versus 65.4%, P < 0.001). In particular, ultrasound guidance of knee injections resulted in better accuracy than anatomical guidance (95.8% versus 77.8%, P < 0.001), yielding an odds ratio of 6.4(95% confidence interval 2.9-14). Ultrasound guidance notably improves injection accuracy in the target intra-articular joint space of large joints including the knee. The enhanced injection accuracy achieved with ultrasound needle guidance directly improves patient-reported clinical outcomes and cost-effectiveness. © 2012 Berkoff et al, publisher and licensee Dove Medical Press Ltd.


Miller L.E.,Miller Scientific Consulting Inc. | Ouwehand A.C.,DuPont Company
World Journal of Gastroenterology | Year: 2013

AIM: To determine the efficacy of probiotic supplementation on intestinal transit time (ITT) and to identify factors that influence these outcomes. METHODS: A systematic review of randomized controlled trials (RCTs) of probiotic supplementation that measured ITT in adults was conducted by searching MEDLINE and EMBASE using relevant key word combinations. Main search limits included RCTs of probiotic supplementation in healthy or constipated adults that measured ITT. Study quality was assessed using the Jadad scale. A random effects meta-analysis was performed with standardized mean difference (SMD) of ITT between probiotic and control groups as the primary outcome. Meta-regression and subgroup analyses were conducted to examine the impact of moderator variables on ITT SMD. RESULTS: A total of 11 clinical trials with 13 treatment effects representing 464 subjects were included in this analysis. Probiotic supplementation was associated with decreased ITT in relation to controls, with an SMD of 0.40 (95%CI: 0.20-0.59, P < 0.001). Constipation (r2 = 39%, P = 0.01), higher mean age (r2 = 27%, P = 0.03), and higher percentage of female subjects (r2 = 23%, P < 0.05) were predictive of decreased ITT with probiotics in meta-regression. Subgroup analyses demonstrated statistically greater reductions in ITT with probiotics in subjects with vs without constipation and in older vs younger subjects [both SMD: 0.59 (95%CI: 0.39-0.79) vs 0.17 (95%CI: -0.08-0.42), P = 0.01]. Medium to large treatment effects were identified with Bifidobacterium Lactis (B. lactis) HN019 (SMD: 0.72, 95%CI: 0.27-1.18, P < 0.01) and B. lactis DN-173 010 (SMD: 0.54, 95%CI: 0.15-0.94, P < 0.01) while other single strains and combination products yielded small treatment effects. CONCLUSION: Overall, short-term probiotic supplementation decreases ITT with consistently greater treatment effects identified in constipated or older adults and with certain probiotic strains. © 2013 Baishideng. All rights reserved.


Razavi M.K.,St Joseph Hospital | Mustapha J.A.,Metro Heart and Vascular | Miller L.E.,Miller Scientific Consulting Inc.
Journal of Vascular and Interventional Radiology | Year: 2014

Purpose The need for specialty devices to improve the technical outcome of endovascular interventions is dependent on the rate of early failure in such procedures. This meta-analysis assessed procedural outcomes of such interventions to elucidate the rate of early procedural failures and the need for such specialty devices.Materials and Methods MEDLINE and EMBASE were searched for contemporary studies (2000-2012) reporting procedural or short-term outcomes for revascularization of infrapopliteal atherosclerotic lesions. A random-effects metaanalysis was performed, which included post hoc comparisons among treatment groups.Results A total of 42 studies with 52 treatment arms representing 3,660 unique patients were included. Technical success rates were higher with bare metal stents (BMSs; 98.6%) than with atherectomy (92.2%; P <.05) or percutaneous transluminal angioplasty (PTA; 91.2%; P =.01), and higher with drug-eluting stents (DESs) than with PTA (P <.001). DES use had higher primary patency rates than atherectomy (P <.05), BMS use (P <.001), and PTA (P <.01). The 30-day rate of target lesion revascularization was significantly higher with PTA (8.1%) than with BMSs (2.2%; P <.05) and DESs (1.1%; P <.05). Thirty-day rates of major unplanned amputation (range, 1.5%-4.4%) and mortality (range, 0.9%-3.3%) were comparable among treatment groups. Significant heterogeneity among studies was noted for most PTA outcomes. Publication bias was evident for most PTA and DES outcomes.Conclusions Early failure of percutaneous therapies in patients with infrapopliteal atherosclerotic lesions is device- and technique-dependent. Specialty devices designed to reduce technical failure rates may therefore be of benefit in this selected group of patients. Study results are confounded by inconsistent data reporting, heterogeneity of treatment effects, and publication bias. © 2014 SIR.


Miller L.E.,Miller Scientific Consulting Inc. | Miller V.M.,Miller Scientific Consulting Inc.
British Journal of Neurosurgery | Year: 2012

Introduction. Hemifacial spasm (HFS) is caused by vascular compression of the VII cranial nerve at its root exit zone from the brainstem. Microvascular decompression (MVD) is the only treatment option that offers the prospect of a definitive cure for HFS. We conducted the first systematic review on the safety and effectiveness of MVD for the treatment of HFS. Methods. English-language studies on MVD for HFS published from 2000 to present were retrieved and summarized. The primary outcomes of interest were treatment success, recurrence rate and adverse events including mortality, stroke, cerebrospinal fluid leak, facial palsy (permanent and transient) and hearing deficit (permanent and transient). Results. Twenty-two papers representing 5685 patients treated with MVD for HFS were included in this review. Complete resolution of symptoms following MVD was reported in 91.1% of patients over a median 2.9-year follow-up period. HFS symptoms recurred in 2.4% of patients and 1.2% underwent repeat MVD during the follow-up period. Transient complications included facial palsy (9.5%), hearing deficit (3.2%) and cerebrospinal fluid leak (1.4%). Permanent complications included hearing deficit (2.3%), facial palsy (0.9%), stroke (< 0.1%) and death (< 0.1%). Conclusions. MVD successfully relieves HFS in approximately 9 of 10 patients with low rates of symptom recurrence. Complications of this surgery are uncommon and generally transient. © 2012 The Neurosurgical Foundation.


Miller L.E.,Miller Scientific Consulting Inc.
Annals of Gastroenterology | Year: 2014

Clinical trials of therapies intended to alleviate symptoms of irritable bowel syndrome (IBS) are prevalent. However, the ideal study design remains elusive since there is no obvious pathophysiological target and no universally accepted endpoint to assess symptom improvement in IBS. The purpose of this paper is to identify and discuss the most problematic issues in the design of clinical trials intended to evaluate the effectiveness of treatments for IBS symptoms. Lack of standardized diagnostic criteria, symptom variability, heterogeneous subject characteristics, large placebo effects, lack of statistical power, inappropriate endpoint selection, and poorly selected study design are the most critical issues that may confound study outcomes in IBS clinical trials. © 2014 Hellenic Society of Gastroenterology.


Miller L.E.,Miller Scientific Consulting Inc.
The Scientific World Journal | Year: 2012

Blunt thoracic aortic injury (BTAI) is a rare, but lethal, consequence of rapid deceleration events. Most victims of BTAI die at the scene of the accident. Of those who arrive to the hospital alive, expedient aortic intervention significantly improves survival. Thoracic endovascular aortic repair (TEVAR) has been accepted as the standard of care for BTAI at many centers, primarily due to the convincing evidence of lower mortality and morbidity in comparison to open surgery. However, less attention has been given to potential long-term complications of TEVAR for BTAI. This paper focuses on these complications, which include progressive aortic expansion with aging, inadequate stent graft characteristics, device durability concerns, long-term radiation exposure concerns from follow-up computed tomography scans, and the potential for (Victims of Modern Imaging Technology) VOMIT. Copyright 2012 Larry E. Miller.

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