Your browser doesn't support javascript.
loading
Mostrar: 20 | 50 | 100
Resultados 1 - 15 de 15
Filtrar
1.
Pain Physician ; 24(S1): S27-S208, 2021 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-33492918

RESUMO

BACKGROUND: Chronic spinal pain is the most prevalent chronic disease with employment of multiple modes of interventional techniques including epidural interventions. Multiple randomized controlled trials (RCTs), observational studies, systematic reviews, and guidelines have been published. The recent review of the utilization patterns and expenditures show that there has been a decline in utilization of epidural injections with decrease in inflation adjusted costs from 2009 to 2018. The American Society of Interventional Pain Physicians (ASIPP) published guidelines for interventional techniques in 2013, and guidelines for facet joint interventions in 2020. Consequently, these guidelines have been prepared to update previously existing guidelines. OBJECTIVE: To provide evidence-based guidance in performing therapeutic epidural procedures, including caudal, interlaminar in lumbar, cervical, and thoracic spinal regions, transforaminal in lumbar spine, and percutaneous adhesiolysis in the lumbar spine. METHODS: The methodology utilized included the development of objective and key questions with utilization of trustworthy standards. The literature pertaining to all aspects of epidural interventions was viewed with best evidence synthesis of available literature and  recommendations were provided. RESULTS: In preparation of the guidelines, extensive literature review was performed. In addition to review of multiple manuscripts in reference to utilization, expenditures, anatomical and pathophysiological considerations, pharmacological and harmful effects of drugs and procedures, for evidence synthesis we have included 47 systematic reviews and 43 RCTs covering all epidural interventions to meet the objectives.The evidence recommendations are as follows: Disc herniation: Based on relevant, high-quality fluoroscopically guided epidural injections, with or without steroids, and results of previous systematic reviews, the evidence is Level I for caudal epidural injections, lumbar interlaminar epidural injections, lumbar transforaminal epidural injections, and cervical interlaminar epidural injections with strong recommendation for long-term effectiveness.The evidence for percutaneous adhesiolysis in managing disc herniation based on one high-quality, placebo-controlled RCT is Level II with moderate to strong recommendation for long-term improvement in patients nonresponsive to conservative management and fluoroscopically guided epidural injections. For thoracic disc herniation, based on one relevant, high-quality RCT of thoracic epidural with fluoroscopic guidance, with or without steroids, the evidence is Level II with moderate to strong recommendation for long-term effectiveness.Spinal stenosis: The evidence based on one high-quality RCT in each category the evidence is Level III to II for fluoroscopically guided caudal epidural injections with moderate to strong recommendation and Level II for fluoroscopically guided lumbar and cervical interlaminar epidural injections with moderate to strong recommendation for long-term effectiveness.The evidence for lumbar transforaminal epidural injections is Level IV to III with moderate recommendation with fluoroscopically guided lumbar transforaminal epidural injections for long-term improvement. The evidence for percutaneous adhesiolysis in lumbar stenosis based on relevant, moderate to high quality RCTs, observational studies, and systematic reviews is Level II with moderate to strong recommendation for long-term improvement after failure of conservative management and fluoroscopically guided epidural injections. Axial discogenic pain: The evidence for axial discogenic pain without facet joint pain or sacroiliac joint pain in the lumbar and cervical spine with fluoroscopically guided caudal, lumbar and cervical interlaminar epidural injections, based on one relevant high quality RCT in each category is Level II with moderate to strong recommendation for long-term improvement, with or without steroids. Post-surgery syndrome: The evidence for lumbar and cervical post-surgery syndrome based on one relevant, high-quality RCT with fluoroscopic guidance for caudal and cervical interlaminar epidural injections, with or without steroids, is Level II with moderate to strong recommendation for long-term improvement. For percutaneous adhesiolysis, based on multiple moderate to high-quality RCTs and systematic reviews, the evidence is Level I with strong recommendation for long-term improvement after failure of conservative management and fluoroscopically guided epidural injections. LIMITATIONS: The limitations of these guidelines include a continued paucity of high-quality studies for some techniques and various conditions including spinal stenosis, post-surgery syndrome, and discogenic pain. CONCLUSIONS: These epidural intervention guidelines including percutaneous adhesiolysis were prepared with a comprehensive review of the literature with methodologic quality assessment and determination of level of evidence with strength of recommendations.

2.
Pain Physician ; 24(1): 17-29, 2021 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-33400425

RESUMO

BACKGROUND: Percutaneous epidural adhesiolysis is a minimally invasive therapeutic modality used in the treatment of patients with chronic low back and lower extremity pain, often recalcitrant to other modalities including epidural injections and surgical interventions. While the initial utilization since its introduction and development of appropriate Current Procedural Terminology (CPT) codes increased up until 2008, but since 2009, there has been a significant decline in utilization of these procedures in the Medicare population. These procedures declined by 53.2% at an annual rate of 10.3% from 2009 to 2016. A recent update analysis on the reversal and decline of growth of utilization of interventional techniques in managing chronic pain in the Medicare population from 2009 to 2018 revealed an even further decline of adhesiolysis procedures. STUDY DESIGN: An analysis of the utilization patterns of percutaneous adhesiolysis procedures in managing chronic low back and lower extremity pain in the Medicare population from 2000 to 2018, with comparative analysis from 2000 to 2009 and 2009 to 2018. OBJECTIVE: To assess the utilization patterns of percutaneous adhesiolysis in managing chronic low back pain in the Medicare population. METHODS: The Centers for Medicare and Medicaid Services (CMS) Physician Supplier Procedure Summary Master of Fee-For-Service (FFS) Data from 2000 to 2018 was used.In this analysis, various variables were assessed in reference to usage patterns of percutaneous adhesiolysis procedures with analysis of growth or declining utilization patterns. We also assessed specialty-based utilization, as well as statewide utilization. RESULTS: The decline of percutaneous adhesiolysis procedures began in 2009 and has continued since then. From 2009 to 2018, the overall decline was 69.2%, with an annual decline of 12.3% compared to an overall 62.6% increase from 2000 to 2009, with an annual increase of 5.6%. Compared to multiple other interventions, including epidural injections and facet joint interventions, percutaneous adhesiolysis has declined at a rapid rate. CONCLUSIONS: This assessment in the FFS Medicare population in the United States shows an irreversible decline of utilization of percutaneous adhesiolysis procedures, which has been gradually deteriorating with a 69.2% decline from 2009 to 2018 with an annual decline of 12.3% during that same time period.

3.
Pain Physician ; 23(6): 531-540, 2020 11.
Artigo em Inglês | MEDLINE | ID: mdl-33185369

RESUMO

BACKGROUND: Research into cervical spinal pain syndromes has indicated that the cervical facet joints can be a potent source of neck pain, headache, and referred pain into the upper extremities. There have been multiple diagnostic accuracy studies, most commonly utilizing diagnostic facet joint nerve blocks and an acute pain model, as Bogduk has proposed. Subsequently, Manchikanti has focused on the importance of the chronic pain model and longer lasting relief with diagnostic blocks. OBJECTIVE: To assess diagnostic accuracy of cervical facet joint nerve blocks with controlled comparative local anesthetic blocks, with updated assessment of prevalence, false-positive rate, and a description of philosophical paradigm shift from acute to chronic pain model, with concordant pain relief. STUDY DESIGN: This diagnostic accuracy study was performed with retrospective assessment of data to assess prevalence and false-positive rates. SETTING: The study was performed in a non-university-based, multidisciplinary, interventional pain management, private practice in the United States. METHODS: Cervical medial branch blocks were performed utilizing lidocaine 1% followed by bupivacaine 0.25% when appropriate response was obtained in an operating room under fluoroscopic guidance with 0.5 mL of lidocaine or bupivacaine from C3-C6 medial branches (levels blocked on joints involved). If a patient failed to respond to lidocaine with appropriate >= 80% pain relief, that patient was considered as negative for facet joint pain. If the response was positive with lidocaine block, a bupivacaine block was performed. RESULTS: The chronic cervical facet joint pain was diagnosed with cervical facet joint nerve blocks at a prevalence of 49.3% (95% CI, 43.6%, 55.0%) and with a false-positive rate of 25.6% (95% CI, 19.5%, 32.8%). This study also showed a single block prevalence rate of 66.3% (95% CI, 71.7%, 60.9%). Assessment of the duration of relief with each block showed greater than 80% for 6 days with lidocaine block and total relief of >= 50% of 31 days. In contrast, with bupivacaine, average duration of pain relief of >= 80% was 12 days with a total relief of >= 50% lasting for 55 days. CONCLUSION: Based on this investigation, utilizing a chronic pain model, there was significant difference in the relief patterns. This assessment showed prevalence and false-positive rates of 49.3% and 25.6% in chronic neck pain. Duration of relief >= 80% pain relief was 6 days with lidocaine and 12 days with bupivacaine, with total relief of >= 50% of 31 days with 55 days respectively.

4.
Pain Physician ; 23(5): 439-450, 2020 09.
Artigo em Inglês | MEDLINE | ID: mdl-32967386

RESUMO

BACKGROUND: Sacroiliac joint is one of the proven causes of low back and lower extremity pain. Prevalence estimates of sacroiliac joint pain range from 10% to 25% in patients with persistent axial low back pain without disc herniation, discogenic pain, or radiculitis based on multiple diagnostic studies and systematic reviews. Over the years, utilization patterns of sacroiliac joint injections have been increasing in comparison to other interventional techniques. Further, the development of new current procedural terminology (CPT) codes and coverage policies for sacroiliac joint nerve blocks, sacroiliac joint radiofrequency neurotomy, and evolving evidence for sacroiliac joint fusion will further increase the utilization patterns. STUDY DESIGN: Analysis of growth patterns of sacroiliac joint injections from 2000 to 2018 with comparative analysis of 2000 to 2009 and 2009 to 2018. OBJECTIVES: To assess utilization patterns of sacroiliac joint injections from 2000 to 2018. METHODS: The Centers for Medicare and Medicaid Services (CMS) Physician/Supplier Procedure Summary (PSPS) Master dataset was utilized in this analysis. RESULTS: The results of the evaluation from 2009 to 2018 showed an increase of 11.3% and an annual increase of 1.2% per 100,000 Medicare population. However, from 2000 to 2009, an increase of 299.8% from 2000 to 2009 with an annual increase of 16.6% per 100,000 Medicare population. LIMITATIONS: The limitations of this study included a lack of data on the new sacroiliac joint nerve block and radiofrequency neurotomy codes. Further, this data did not include utilization patterns of sacroiliac joint fusions. In addition, Medicare Advantage patients were not included, which constitute approximately 30% of overall Medicare population. Further, there is also a possibility that state claims data may include claims from other states. As with all claims-based data analyses, this study is retrospective and thus potentially limited by bias. Finally, patients who are self or commercially insured are not part of the dataset. CONCLUSIONS: This study shows increases in utilization patterns of sacroiliac joint injections; however, at a significantly lower rate with an annual increase of 16.6% prior to 2009 and only 1.2% from 2009 to 2018 per 100,000 Medicare beneficiaries.

5.
Pain Physician ; 23(5): 519-530, 2020 09.
Artigo em Inglês | MEDLINE | ID: mdl-32967394

RESUMO

BACKGROUND: Lumbar facet joints are a clinically important source of chronic low back pain. There have been extensive diagnostic accuracy studies, along with studies of influence on the diagnostic process, but most of them have utilized the acute pain model. One group of investigators have emphasized the importance of the chronic pain model and longer lasting relief with diagnostic blocks. OBJECTIVE: To assess the diagnostic accuracy of lumbar facet joint nerve blocks with controlled comparative local anesthetic blocks and concordant pain relief with an updated assessment of the prevalence, false-positive rates, and a description of a philosophical paradigm shift from an acute to a chronic pain model. STUDY DESIGN: Retrospective study to determine diagnostic accuracy, prevalence and false-positive rates. SETTING: A multidisciplinary, non-university based interventional pain management practice in the United States. METHODS: Controlled comparative local anesthetic blocks were performed initially with 1% lidocaine, followed by 0.25% bupivacaine if appropriate response was obtained, in an operating room under fluoroscopic guidance utilizing 0.5 mL of lidocaine or bupivacaine at L3, L4 medial branches and L5 dorsal ramus. All patients non-responsive to lidocaine blocks were considered to be negative for facet joint pain. All patients were assessed after the diagnostic blocks were performed with >= 80% pain relief for their ability to perform previously painful movements. RESULTS: The prevalence of lumbar facet joint pain in chronic low back pain was 34.1% (95% CI, 28.8%, 39.8%), with a false-positive rate of 49.8% (95% CI, 42.7%, 56.8%). This study also showed a single block prevalence rate of 67.9% (95% CI, 62.9%, 73.2%). Average duration of pain relief >= 80% was 6 days with lidocaine block and total relief of >= 50% of 32 days. With bupivacaine, the average duration of pain relief >= 80% was 13 days with total relief of >= 50% lasting for 55 days. CONCLUSION: This study demonstrated that the chronic pain model is more accurate and reliable with concordant pain relief. This updated assessment also showed prevalence and false-positive rates of 34.1% and 49.8%.

6.
Pain Physician ; 23(4S): S319-S350, 2020 08.
Artigo em Inglês | MEDLINE | ID: mdl-32942792

RESUMO

BACKGROUND: Since the late 1940s, corticosteroids have been a mainstay class of agents in multiple interventional techniques and intra-articular injections. Exogenous glucocorticoids are structurally and pharmacologically similar to the endogenous hormones. As such, multiple actions of corticosteroids are exhibited, including those of anti-inflammatory and immunosuppressive effects. Epidural injections, with or without steroids, have been extensively used throughout the world. There are reports of epidural injections starting in 1901, with steroids being added to the local anesthetic since 1952, when steroids were administered into the sacral foramen. PURPOSE: Due to the extensive side effects of steroids in various injections, some have proposed limiting their use in epidurals and intraarticular injections. With the COVID-19 pandemic, the multiple side effects of the steroids have elevated the level of concern and recommendations have been made to utilize local anesthetic alone or the lowest dose of steroids. Fashioned from common expressions of the day, the term "steroid distancing" began to be used and proposed for intraarticular injections of the knee. Consequently, we sought to evaluate the evidence and feasibility of steroid distancing in interventional pain management. METHODS: This focused review of local anesthetics and steroids utilized in interventional pain management for epidural injections, peripheral nerve blocks, and intraarticular injections by multiple database searches. This is a focused narrative review and not a systematic review. Consequently, evidence synthesis was not performed traditionally, but was based on an overview of the available evidence. RESULTS: No significant difference was identified based on whether steroids are added to local anesthetic or not for epidural as well as facet joint injections. However, there was not enough evidence to compare these two groups for peripheral intraarticular injections. LIMITATIONS: The present review is limited by the paucity of literature with bupivacaine alone or bupivacaine with steroids local anesthetic alone or with steroids of intraarticular injections of knee, hip, shoulder and other joints, and intraarticular facet joint injections. CONCLUSION: This review shows an overall lack of significant difference between lidocaine alone and lidocaine with steroids in epidural injections. However, available evidence is limited for bupivacaine alone or with steroids. Evidence is also not available comparing local anesthetic alone with steroids for facet joint or peripheral joint intraarticular injections. Thus, it is concluded that local anesthetic with lidocaine may be utilized for epidural injections, with appropriate patient selection and steroids reserved for non-responsive patients with local anesthetic and with significant radiculitis.


Assuntos
Corticosteroides/uso terapêutico , Anestésicos Locais/uso terapêutico , Infecções por Coronavirus , Manejo da Dor/métodos , Pandemias , Pneumonia Viral , Anti-Inflamatórios/uso terapêutico , Betacoronavirus , Humanos , Injeções Epidurais/métodos , Injeções Intra-Articulares/métodos
7.
Pain Physician ; 23(3S): S1-S127, 2020 05.
Artigo em Inglês | MEDLINE | ID: mdl-32503359

RESUMO

BACKGROUND: Chronic axial spinal pain is one of the major causes of significant disability and health care costs, with facet joints as one of the proven causes of pain. OBJECTIVE: To provide evidence-based guidance in performing diagnostic and therapeutic facet joint interventions. METHODS: The methodology utilized included the development of objectives and key questions with utilization of trustworthy standards. The literature pertaining to all aspects of facet joint interventions, was reviewed, with a best evidence synthesis of available literature and utilizing grading for recommendations.Summary of Evidence and Recommendations:Non-interventional diagnosis: • The level of evidence is II in selecting patients for facet joint nerve blocks at least 3 months after onset and failure of conservative management, with strong strength of recommendation for physical examination and clinical assessment. • The level of evidence is IV for accurate diagnosis of facet joint pain with physical examination based on symptoms and signs, with weak strength of recommendation. Imaging: • The level of evidence is I with strong strength of recommendation, for mandatory fluoroscopic or computed tomography (CT) guidance for all facet joint interventions. • The level of evidence is III with weak strength of recommendation for single photon emission computed tomography (SPECT) . • The level of evidence is V with weak strength of recommendation for scintography, magnetic resonance imaging (MRI), and computed tomography (CT) .Interventional Diagnosis:Lumbar Spine: • The level of evidence is I to II with moderate to strong strength of recommendation for lumbar diagnostic facet joint nerve blocks. • Ten relevant diagnostic accuracy studies with 4 of 10 studies utilizing controlled comparative local anesthetics with concordant pain relief criterion standard of ≥80% were included. • The prevalence rates ranged from 27% to 40% with false-positive rates of 27% to 47%, with ≥80% pain relief.Cervical Spine: • The level of evidence is II with moderate strength of recommendation. • Ten relevant diagnostic accuracy studies, 9 of the 10 studies with either controlled comparative local anesthetic blocks or placebo controls with concordant pain relief with a criterion standard of ≥80% were included. • The prevalence and false-positive rates ranged from 29% to 60% and of 27% to 63%, with high variability. Thoracic Spine: • The level of evidence is II with moderate strength of recommendation. • Three relevant diagnostic accuracy studies, with controlled comparative local anesthetic blocks, with concordant pain relief, with a criterion standard of ≥80% were included. • The prevalence varied from 34% to 48%, whereas false-positive rates varied from 42% to 58%.Therapeutic Facet Joint Interventions: Lumbar Spine: • The level of evidence is II with moderate strength of recommendation for lumbar radiofrequency ablation with inclusion of 11 relevant randomized controlled trials (RCTs) with 2 negative studies and 4 studies with long-term improvement. • The level of evidence is II with moderate strength of recommendation for therapeutic lumbar facet joint nerve blocks with inclusion of 3 relevant randomized controlled trials, with long-term improvement. • The level of evidence is IV with weak strength of recommendation for lumbar facet joint intraarticular injections with inclusion of 9 relevant randomized controlled trials, with majority of them showing lack of effectiveness without the use of local anesthetic. Cervical Spine: • The level of evidence is II with moderate strength of recommendation for cervical radiofrequency ablation with inclusion of one randomized controlled trial with positive results and 2 observational studies with long-term improvement. • The level of evidence is II with moderate strength of recommendation for therapeutic cervical facet joint nerve blocks with inclusion of one relevant randomized controlled trial and 3 observational studies, with long-term improvement. • The level of evidence is V with weak strength of recommendation for cervical intraarticular facet joint injections with inclusion of 3 relevant randomized controlled trials, with 2 observational studies, the majority showing lack of effectiveness, whereas one study with 6-month follow-up, showed lack of long-term improvement. Thoracic Spine: • The level of evidence is III with weak to moderate strength of recommendation with emerging evidence for thoracic radiofrequency ablation with inclusion of one relevant randomized controlled trial and 3 observational studies. • The level of evidence is II with moderate strength of recommendation for thoracic therapeutic facet joint nerve blocks with inclusion of 2 randomized controlled trials and one observational study with long-term improvement. • The level of evidence is III with weak to moderate strength of recommendation for thoracic intraarticular facet joint injections with inclusion of one randomized controlled trial with 6 month follow-up, with emerging evidence. Antithrombotic Therapy: • Facet joint interventions are considered as moderate to low risk procedures; consequently, antithrombotic therapy may be continued based on overall general status. Sedation: • The level of evidence is II with moderate strength of recommendation to avoid opioid analgesics during the diagnosis with interventional techniques. • The level of evidence is II with moderate strength of recommendation that moderate sedation may be utilized for patient comfort and to control anxiety for therapeutic facet joint interventions. LIMITATIONS: The limitations of these guidelines include a paucity of high-quality studies in the majority of aspects of diagnosis and therapy. CONCLUSIONS: These facet joint intervention guidelines were prepared with a comprehensive review of the literature with methodologic quality assessment with determination of level of evidence and strength of recommendations. KEY WORDS: Chronic spinal pain, interventional techniques, diagnostic blocks, therapeutic interventions, facet joint nerve blocks, intraarticular injections, radiofrequency neurolysis.


Assuntos
Dor nas Costas/terapia , Dor Crônica/terapia , Manejo da Dor/métodos , Articulação Zigapofisária , Humanos , Estados Unidos
8.
Pain physician ; 23(3S): S1-S127, May 2020.
Artigo em Inglês | BIGG - guias GRADE | ID: biblio-1129928

RESUMO

Chronic axial spinal pain is one of the major causes of significant disability and health care costs, with facet joints as one of the proven causes of pain. To provide evidence-based guidance in performing diagnostic and therapeutic facet joint interventions. The methodology utilized included the development of objectives and key questions with utilization of trustworthy standards. The literature pertaining to all aspects of facet joint interventions, was reviewed, with a best evidence synthesis of available literature and utilizing grading for recommendations.


Assuntos
Humanos , Masculino , Feminino , Bloqueio Nervoso Autônomo , Dor nas Costas/terapia , Denervação/métodos , Dor Crônica/terapia , Manejo da Dor/métodos , Terapia por Radiofrequência , Avaliação de Resultado de Intervenções Terapêuticas , Injeções Intra-Articulares
9.
Pain Physician ; 23(2): E85-E131, 2020 03.
Artigo em Inglês | MEDLINE | ID: mdl-32214287

RESUMO

BACKGROUND: The use of bone marrow concentrate (BMC) for treatment of musculoskeletal disorders has become increasingly popular over the last several years, as technology has improved along with the need for better solutions for these pathologies. The use of cellular tissue raises a number of issues regarding the US Food and Drug Administration's (FDA) regulation in classifying these treatments as a drug versus just autologous tissue transplantation. In the case of BMC in musculoskeletal and spine care, this determination will likely hinge on whether BMC is homologous to the musculoskeletal system and spine. OBJECTIVES: The aim of this review is to describe the current regulatory guidelines set in place by the FDA, specifically the terminology around "minimal manipulation" and "homologous use" within Regulation 21 CFR Part 1271, and specifically how this applies to the use of BMC in interventional musculoskeletal medicine. METHODS: The methodology utilized here is similar to the methodology utilized in preparation of multiple guidelines employing the experience of a panel of experts from various medical specialties and subspecialties from differing regions of the world. The collaborators who developed these position statements have submitted their appropriate disclosures of conflicts of interest. Trustworthy standards were employed in the creation of these position statements. The literature pertaining to BMC, its effectiveness, adverse consequences, FDA regulations, criteria for meeting the standards of minimal manipulation, and homologous use were comprehensively reviewed using a best evidence synthesis of the available and relevant literature. RESULTS/Summary of Evidence: In conjunction with evidence-based medicine principles, the following position statements were developed: Statement 1: Based on a review of the literature in discussing the preparation of BMC using accepted methodologies, there is strong evidence of minimal manipulation in its preparation, and moderate evidence for homologous utility for various musculoskeletal and spinal conditions qualifies for the same surgical exemption. Statement 2: Assessment of clinical effectiveness based on extensive literature shows emerging evidence for multiple musculoskeletal and spinal conditions. • The evidence is highest for knee osteoarthritis with level II evidence based on relevant systematic reviews, randomized controlled trials and nonrandomized studies. There is level III evidence for knee cartilage conditions. • Based on the relevant systematic reviews, randomized trials, and nonrandomized studies, the evidence for disc injections is level III. • Based on the available literature without appropriate systematic reviews or randomized controlled trials, the evidence for all other conditions is level IV or limited for BMC injections. Statement 3: Based on an extensive review of the literature, there is strong evidence for the safety of BMC when performed by trained physicians with the appropriate precautions under image guidance utilizing a sterile technique. Statement 4: Musculoskeletal disorders and spinal disorders with related disability for economic and human toll, despite advancements with a wide array of treatment modalities. Statement 5: The 21st Century Cures Act was enacted in December 2016 with provisions to accelerate the development and translation of promising new therapies into clinical evaluation and use. Statement 6: Development of cell-based therapies is rapidly proliferating in a number of disease areas, including musculoskeletal disorders and spine. With mixed results, these therapies are greatly outpacing the evidence. The reckless publicity with unsubstantiated claims of beneficial outcomes having putative potential, and has led the FDA Federal Trade Commission (FTC) to issue multiple warnings. Thus the US FDA is considering the appropriateness of using various therapies, including BMC, for homologous use. Statement 7: Since the 1980's and the description of mesenchymal stem cells by Caplan et al, (now called medicinal signaling cells), the use of BMC in musculoskeletal and spinal disorders has been increasing in the management of pain and promoting tissue healing. Statement 8: The Public Health Service Act (PHSA) of the FDA requires minimal manipulation under same surgical procedure exemption. Homologous use of BMC in musculoskeletal and spinal disorders is provided by preclinical and clinical evidence. Statement 9: If the FDA does not accept BMC as homologous, then it will require an Investigational New Drug (IND) classification with FDA (351) cellular drug approval for use. Statement 10: This literature review and these position statements establish compliance with the FDA's intent and corroborates its present description of BMC as homologous with same surgical exemption, and exempt from IND, for use of BMC for treatment of musculoskeletal tissues, such as cartilage, bones, ligaments, muscles, tendons, and spinal discs. CONCLUSIONS: Based on the review of all available and pertinent literature, multiple position statements have been developed showing that BMC in musculoskeletal disorders meets the criteria of minimal manipulation and homologous use. KEY WORDS: Cell-based therapies, bone marrow concentrate, mesenchymal stem cells, medicinal signaling cells, Food and Drug Administration, human cells, tissues, and cellular tissue-based products, Public Health Service Act (PHSA), minimal manipulation, homologous use, same surgical procedure exemption.


Assuntos
Transplante de Medula Óssea/normas , Medicina Baseada em Evidências/normas , Doenças Musculoesqueléticas/terapia , Manejo da Dor/normas , Médicos/normas , Sociedades Médicas/normas , Medula Óssea/fisiologia , Transplante de Medula Óssea/métodos , Medicina Baseada em Evidências/métodos , Humanos , Doenças Musculoesqueléticas/diagnóstico , Doenças Musculoesqueléticas/epidemiologia , Dor/diagnóstico , Dor/epidemiologia , Manejo da Dor/métodos , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Resultado do Tratamento , Estados Unidos , United States Food and Drug Administration/normas
10.
Int J Med Robot ; 11(3): 275-283, 2015 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-25417602

RESUMO

BACKGROUND: The introduction of the robotic platform to bariatric surgery has brought forth a novel approach, with modifications to the standard laparoscopic sleeve gastrectomy (LSG) and laparoscopic gastric bypass (LGB). The purpose of this study was to match robotic gastric bypass (RGB) vs robotic sleeve gastrectomy (RSG) and compare them to those observed with the laparoscopic platform. METHODS: A retrospective data collection of RSGs and RGBs from a single institution was performed. Groups were compared. RESULTS: This study included 134 RSG and 165 RGB patients. RGB has a longer surgical time (p < 0.001) and a higher incidence of long-term complications (p = 0.005) but similar lengths of hospital stay (p = 0.093), rate of perioperative complications (p = 0.487) and EWL% at 1 year of follow-up compared to RSG. CONCLUSIONS: RSGs had shorter surgical times and a lower incidence of long-term complications when compared with RGBs. These results appear to be similar to those studies reporting the laparoscopic approach. Copyright © 2014 John Wiley & Sons, Ltd.

11.
JSLS ; 18(1): 8-13, 2014.
Artigo em Inglês | MEDLINE | ID: mdl-24809141

RESUMO

BACKGROUND AND OBJECTIVES: Minimally invasive surgery fellowship programs have been created in response to advancements in technology and patient's demands. Single-incision laparoscopic cholecystectomy (SILC) is a technique that has been shown to be safe and feasible, but this appears to be the case only for experienced surgeons. The purpose of this study is to evaluate the impact of minimally invasive surgery fellow participation during SILC. METHODS: We reviewed data from our experience with SILC during 3 years. The cases were divided in two groups: group 1 comprised procedures performed by the main attending without the presence of the fellow, and group 2 comprised procedures performed with the fellow present during the operation. Demographic characteristics, comorbidities, indication for surgery, total surgical time, hospital length of stay, and complications were evaluated. RESULTS: The cohort included 229 patients: 142 (62%) were included in group 1 and 87 (38%) in group 2. No differences were found in demographic characteristics, comorbidities, and indication for surgery between groups. The total surgical time was 34.4 ± 11.4 minutes for group 1 and 46.8 ± 16.0 minutes for group 2 (P < .001). The hospital length of stay was 0.89 0.32 days for group 1 and 1.01 ± 0.40 days for group 2 (P = .027). No intraoperative complications were seen in either group. There were 3 postoperative complications (2.1%) in group 1 and none in group 2 (P = .172). CONCLUSION: Adoption of SILC during an established fellowship program is safe and feasible. A longer surgical time is expected during the teaching process.


Assuntos
Colecistectomia Laparoscópica/educação , Educação Médica Continuada/métodos , Internato e Residência , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Competência Clínica , Feminino , Seguimentos , Humanos , Curva de Aprendizado , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Resultado do Tratamento , Adulto Jovem
12.
J Robot Surg ; 8(2): 177-80, 2014 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-27637529

RESUMO

Minimally invasive surgery has been used traditionally for removal of colorectal, gastric and gallbladder disease pathologies with great success. Many advantages have been demonstrated with the addition of robotic surgery, such as 3-D visualization, articulation of instruments and improved surgeon ergonomics while operating. These benefits have allowed the implementation of robotic surgery into new areas. We describe here a rare case of a robotic resection of an urachal carcinoma. A 53-year-old female patient presented to her primary care physician (PCP) with a chief complaint of recurrent urinary tract infections. An initial urinary bladder ultrasound showed a large mass anterior and superior to the bladder, thus prompting an abdominal/pelvic MRI, which confirmed a large complex cystic mass anterior to and abutting the urinary bladder (5.4 × 6.7 × 5.9 cm). A follow-up cystoscopy showed no abnormal findings within the bladder. Based on the patient's symptoms and imaging, a careful evaluation by her PCP, oncology and surgical team prompted for the removal of the mass. Because of the uncertainty, complexity and location of the mass the patient was offered surgical treatment with the da Vinci robot. Histopathology revealed an urachal adenocarcinoma, well differentiated. We present that surgical resection of an urachal tumor can be performed with the da Vinci robot. Robotic surgery can add to the benefits seen with the conventional laparoscopic approach and thus can be an accepted method for treatment of abdominal wall masses.

13.
Surg Endosc ; 27(12): 4524-31, 2013 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-23943118

RESUMO

BACKGROUND: Many series have shown the feasibility and safety of single-incision laparoscopic cholecystectomy (SILC), but this technique still has limitations such as instrument collisions and lack of triangulation. Recently, two single-incision platforms, robotic and SPIDER, have attempted to ameliorate such problems. This study aimed to compare three different techniques of single-incision cholecystectomy: standard laparoscopic, robotic, and SPIDER approaches. METHODS: The authors retrospectively collected data from their first 166 single-incision robotic cholecystectomies (SIRCs) and compared the findings with the data from their first 166 SILCs and the first 166 s-generation SPIDER procedures. All the SILCs were performed with three trocars placed in one umbilical incision and with gallbladder retraction using a Prolene stitch on the right upper quadrant. All the robotic cases were managed using the da Vinci Single-Site Surgical System, and all the SPIDER procedures were performed using the SPIDER Surgical System. RESULTS: The SILC, SIRC, and SPIDER groups consisted respectively of 129 (76.3%), 131 (78.9%), and 136 (81.9%) women with the respective mean ages of 44.5 ± 14.3, 51.6 ± 15.9, and 46.4 ± 15.2 years. The mean body mass indexes (BMIs) were respectively 29.1 ± 5.6, 29.4 ± 6.2, and 27.5 ± 4.8 kg/m(2), and the mean surgical times were 37.1 ± 13.3, 63.0 ± 25.2, and 52.8 ± 18.7 min. The total hospital stays were respectively 1.3 ± 5.3, 1.2 ± 2.2, and 1.5 ± 2.6 days, and complications were seen respectively in three SILC cases (1.8%), three SIRC cases (1.8%), and two SPIDER cases (1.2%). CONCLUSIONS: The results of this study demonstrate similar results among the three platforms for most of the parameters measured. The SILC procedure appears to be superior to SIRC and SPIDER in terms of surgical time, but selection bias could be the cause. The SILS, SIRC, and SPIDER procedures all are similar in terms of complication profile. It can be concluded that SILC, SIRC, and SPIDER all are feasible and safe alternatives when used for single-incision cholecystectomy.


Assuntos
Colecistectomia Laparoscópica/métodos , Doenças da Vesícula Biliar/cirurgia , Robótica/instrumentação , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Colecistectomia Laparoscópica/normas , Desenho de Equipamento , Estudos de Viabilidade , Feminino , Humanos , Tempo de Internação/tendências , Masculino , Pessoa de Meia-Idade , Duração da Cirurgia , Estudos Retrospectivos , Robótica/normas , Resultado do Tratamento , Adulto Jovem
14.
Obes Surg ; 23(11): 1743-52, 2013 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-23904057

RESUMO

BACKGROUND: Robotic technology has recently emerged in different surgical specialties, but the experience with robotic sleeve gastrectomy (RSG) is scarce in the literature. The purpose of this study is to compare our preliminary experience with RSG versus the descriptive results of a systematic review of the laparoscopic approach. METHODS: Data from our RSG experience were retrospectively collected. Two surgeons performed all the cases in one single surgery center. Such information was compared with a systematic review of 22 selected studies that included 3,148 laparoscopic sleeve gastrectomy (LSG) cases. RSG were performed using the daVinci Surgical System. RESULTS: This study included 134 RSG vs. 3,148 LSG. Mean age and mean BMI was 43 ± 12.6 vs. 40.7 ± 11.6 (p = 0.022), and 45 ± 7.1 vs. 43.6 ± 8.1 (p = 0.043), respectively. Leaks were found in 0 RSG vs. 1.97% LSG (p = 0.101); strictures in 0 vs. 0.43% (p = 0.447); bleeding in 0.7 vs. 1.21% (p = 0.594); and mortality in 0 vs. 0.1% (p = 0.714), respectively. Mean surgical time was calculated in 106.6 ± 48.8 vs. 94.5 ± 39.9 min (p = 0.006); and mean hospital length of stay was 2.2 ± 0.6 vs. 3.3 ± 1.7 days (p = <0.005), respectively. Four (2.9%) complications were found in our robotic series. CONCLUSIONS: Our series shows that RSG is a safe alternative when used in bariatric surgery, showing similar results as the laparoscopic approach. Surgical time is longer in the robotic approach, while hospital length of stay is lower. No leaks or strictures were found in the robotic cases. However, further studies with larger sample size and randomization are warranted.


Assuntos
Gastrectomia/métodos , Laparoscopia , Tempo de Internação/estatística & dados numéricos , Obesidade Mórbida/cirurgia , Complicações Pós-Operatórias/cirurgia , Robótica , Cirurgia Assistida por Computador , Adulto , Índice de Massa Corporal , Feminino , Humanos , Masculino , Obesidade Mórbida/epidemiologia , Complicações Pós-Operatórias/epidemiologia , Estudos Retrospectivos , Fatores de Tempo , Resultado do Tratamento , Perda de Peso
15.
JSLS ; 17(4): 570-7, 2013.
Artigo em Inglês | MEDLINE | ID: mdl-24398199

RESUMO

BACKGROUND AND OBJECTIVES: Giant paraesophageal hernia accounts for 5% of all hiatal hernias, and it is commonly seen in elderly patients with comorbidities. Some series report complication rates up to 28%, recurrence rates between 10% and 25%, and a mortality rate close to 2%. Recently, the da Vinci Surgical System (Intuitive Surgical, Sunnyvale, CA, USA) has shown equivocal benefits when used for elective surgeries, whereas for complex procedures, the benefits appear to be clearer. The purpose of this study is to present our preliminary experience in robotic giant paraesophageal hernia repair. METHODS: We retrospectively collected data from patients who had a diagnosis of giant paraesophageal hernia and underwent a paraesophageal hernia repair with the da Vinci Surgical System. RESULTS: Nineteen patients (12 women [63.1%]) underwent surgery for giant paraesophageal hernia at our center. The mean age was 70.4 ± 13.9 years (range, 40-97 years). The mean American Society of Anesthesiologists score was 2.15. The mean surgical time and hospital length of stay were 184.5 ± 96.2 minutes (range, 96-395 minutes) and 4.3 days (range, 2-22 days), respectively. Nissen fundoplications were performed in 3 cases (15.7%), and 16 patients (84.2%) had mesh placed. Six patients (31.5%) presented with gastric volvulus, and 2 patients had other herniated viscera (colon and duodenum). There were 2 surgery-related complications (10.5%) (1 dysphagia that required dilatation and 1 pleural injury) and 1 conversion to open repair (partial gastric resection). No recurrences or deaths were observed in this series. CONCLUSION: In our experience robotic giant paraesophageal hernia repair is not different from the laparoscopic approach in terms of complications and mortality rate, but it may be associated with lower recurrence rates. However, larger series with longer follow-up are necessary to further substantiate our results.


Assuntos
Hérnia Hiatal/cirurgia , Herniorrafia/métodos , Robótica , Adulto , Idoso , Feminino , Hérnia Hiatal/patologia , Humanos , Masculino , Pessoa de Meia-Idade , Recidiva , Estudos Retrospectivos
SELEÇÃO DE REFERÊNCIAS
DETALHE DA PESQUISA
...