Michael Saulino

Jefferson College, Хиллсборо, Missouri, United States

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Publications (27)44.08 Total impact

  • [Show abstract] [Hide abstract]
    ABSTRACT: Objective To compare health-care expenditures over a 12-month horizon for chronic pain patients with implanted intrathecal drug delivery systems (IDDS) who eliminated or continued systemic opioids postimplant.Methods Claims data from commercial and Medicare databases were searched for patients who had an IDDS, used systemic opioids before implant, and had 12 months pre- and 13 months postimplant continuous medical and pharmacy coverage. The number and characteristics of patients who eliminated or continued systemic opioids were determined at four times postimplant: 30 days (allowing a systemic opioid washout period), 120 days, 150 days, and 210 days. Multivariable models evaluated the effect of eliminating opioids on health-care expenditures at each of those times.ResultsThree hundred eighty-nine patients met inclusion criteria, and 51% completely eliminated systemic opioids (12% within the 30-day washout and an additional 39% by the end of the one-year horizon). Systemic opioid elimination within 120 to 210 days postimplant was associated with a reduction of $3,388 to $4,465 in inpatient and outpatient expenditures, and $4,689 to $5,571 in inpatient, outpatient, and drug expenditures.Conclusions Fifty-one percent of patients completely eliminated systemic opioids in the year after IDDS implant. This elimination resulted in a 10% to 17% reduction in yearly inpatient, outpatient, and drug expenditures.
    Neuromodulation 03/2015; 18(3). DOI:10.1111/ner.12278 · 1.79 Impact Factor
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    Michael Saulino · Philip S Kim · Erik Shaw
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    ABSTRACT: Chronic pain continues to pose substantial and growing challenges for patients, caregivers, health care professionals, and health care systems. By the time a patient with severe refractory pain sees a pain specialist for evaluation and management, that patient has likely tried and failed several nonpharmacologic and pharmacologic approaches to pain treatment. Although relegated to one of the interventions of "last resort", intrathecal drug delivery can be useful for improving pain control, optimizing patient functionality, and minimizing the use of systemic pain medications in appropriately selected patients. Due to its clinical and logistical requirements, however, intrathecal drug delivery may fit poorly into the classic pain clinic/interventional model and may be perceived as a "critical mass" intervention that is feasible only for large practices that have specialized staff and appropriate office resources. Potentially, intrathecal drug delivery may be more readily adopted into larger practices that can commit the necessary staff and resources to support patients' needs through the trialing, initiation, monitoring, maintenance, and troubleshooting phases of this therapy. Currently, two agents - morphine and ziconotide - are approved by the United States Food and Drug Administration for long-term intrathecal delivery. The efficacy and safety profiles of morphine have been assessed in long-term, open-label, and retrospective studies of >400 patients with chronic cancer and noncancer pain types. The efficacy and safety profiles of ziconotide have been assessed in three double-blind, placebo-controlled trials of 457 patients, and safety has been assessed in 1,254 patients overall, with severe chronic cancer, noncancer, and acquired immunodeficiency syndrome pain types. Both agents are highlighted as first-line intrathecal therapy for the management of neuropathic or nociceptive pain. The purpose of this review is to discuss practical considerations for intrathecal drug delivery, delineate criteria for the identification and selection of candidates for intrathecal drug delivery, and consider which agent may be more appropriate for individual patients.
    Journal of Pain Research 11/2014; 7:627-638. DOI:10.2147/JPR.S65441
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    ABSTRACT: Objectives To evaluate the economic effects of intrathecal baclofen (ITB) for patients with severe spasticity based on costs of care before and after implantation of an intrathecal drug delivery system.Materials and Methods An actuarial projection of post-implant experience in the absence of ITB intervention was used to simulate a continued conventional medical management protocol (ITB-free) by assuming a reasonable trend rate based on health-care industry standards. Cost projections were developed over a 30-year time horizon at various reimplantation rates. The model was informed by retrospective analysis of commercial administrative claims data from 409 pediatric and adult spasticity patients who received a pump implant (ITB-experienced) within a 3-year service period (January 2006 to January 2009). Common indications associated with pump implant included multiple sclerosis (N = 124), cerebral palsy (N = 131), and spinal cord injury (N = 40).ResultsITB was less costly than the conventional protocol over our baseline implantation cycle. Costs in the month of implant and in the year following were cumulatively $26,375 more than with the conventional protocol. However, ITB financial break-even occurs between the second and third years post-implant. The lifetime analysis indicates that savings for ITB are $8009 per patient per year compared with conventional therapy. Most of the savings are derived from reductions in inpatient admissions, physician office visits, and outpatient physiotherapy.Conclusions The results suggest that spasticity patients receiving ITB would expect to experience a reduction in cumulative future medical costs relative to anticipated costs in the absence of a pump implant. This finding complements the existing literature on the cost-effectiveness of ITB.
    Neuromodulation 09/2014; 18(2). DOI:10.1111/ner.12220 · 1.79 Impact Factor
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    ABSTRACT: We aimed to assess the efficacy of intraoperative vancomycin powder in intrathecal baclofen pump placement patients, a high risk population. A retrospective review was conducted using prospectively collected data at an academic tertiary care unit. The neurosurgical adult patient population was queried for all intrathecal baclofen pump implantation procedures. Patients were then reviewed for the use of intraoperative crystalline vancomycin powder. Those with a history of prior surgical site infection, chronic systemic infections or osteomyelitis were excluded. Anhydrous, crystalline vancomycin was utilized in the wound bed after completion of implantation, distributed evenly in the case of multiple incisions. Patients received 500mg or 1000mg of crystallized vancomycin, evenly distributed through the wound layers based on a 70 kg weight cutoff. Intraoperative institutional standards of infection prophylaxis were unchanged throughout the study period. Infection rate of baclofen pump placement prior to the use of vancomycin powder from 2001-2009 at the same institution was monitored. Wound infection rate was tracked for a 12month postoperative period. Six patients out of 26 baclofen pump implantations (23%) in this cohort were identified to have seven infections despite vancomycin powder placement in the lumbar and catheter wounds. Prior infection rates have been investigated for intrathecal drug delivery systems from 2001 to 2009 at the same institution with an overall infection rate of 3% (8/274). The use of vancomycin powder in patients with implants in this series did not reduce infection rates compared to published historical controls, and was elevated compared to institutional controls. Further prospective study of this high risk patient population is warranted.
    Journal of Clinical Neuroscience 06/2014; 21(10). DOI:10.1016/j.jocn.2014.04.007 · 1.32 Impact Factor
  • Michael Saulino
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    ABSTRACT: Chronic pain associated with traumatic spinal cord injury (SCI) can be quite challenging to the physiatrist. This highly prevalent condition within the SCI population requires an appropriate evaluative approach including a thorough history, a targeted physical examination, and appropriate use of diagnostic testing. The International Spinal Cord Injury Pain Classification allows for a reasonable categorization of the various pain syndromes and may assist in selecting a reasoned treatment strategy. A multitude of management approaches exist including nonpharmacologic, pharmacologic, and interventional approaches. This article provides an overview of the epidemiology, classification, evaluation, and management of SCI-associated pain.
    Physical Medicine and Rehabilitation Clinics of North America 05/2014; 25(2):397-410. DOI:10.1016/j.pmr.2014.01.002 · 1.09 Impact Factor
  • Michael Saulino · Michael Gofeld
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    ABSTRACT: The study aims to demonstrate the unique sonographic features of the commercially available intrathecal drug delivery systems. "Not-for-human-use" pumps were obtained, placed in a tray, and covered with an ultrasound phantom gel. The anterior surface of each pump was scanned and the sonographic features were observed and recorded. All systems have a centrally located reservoir port (RP) and a peripherally located catheter access port (CAP) that are observable on ultrasound. The RP of the SynchroMed II system (Medtronic, Minneapolis, MN, USA) appears as an anechoic depression and a break in the bright echogenic line of the superior pump surface. The CAP appears as smaller diameter conical depression outside the circular perimeter of the pump. The RP of the MedStream system (Codman & Shurtleff, Inc., Raynham, MA, USA) has a dome-shaped appearance. The CAP appears as a smaller dome-shaped object that is off center but still contained within the circular perimeter of the pump. Similarly, the RP of the Prometra system (Flowonix Medical Inc, Mt. Olive, NJ, USA) is a dome-shaped object. The CAP visually appears similar to the reservoir access port of the SynchroMed II system, namely a small depression and a break in the bright echogenic line of the pump surface, outside the perimeter of the pump. In all programmable intrathecal pumps, the RP can be readily identified sonographically. Potentially, the dome-shaped configuration of RP for the Prometra and MedStream systems make the access easier, when compared with SynchroMed II system. Ultrasound could potentially be utilized to localize the RP and CAP for all the systems as each of the three systems has a unique sonographic appearance.
    Neuromodulation 02/2014; 17(7). DOI:10.1111/ner.12159 · 1.79 Impact Factor
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    ABSTRACT: We aimed to assess the efficacy of intraoperative vancomycin powder in intrathecal baclofen pump placement patients, a high risk population. A retrospective review was conducted using prospectively collected data at an academic tertiary care unit. The neurosurgical adult patient population was queried for all intrathecal baclofen pump implantation procedures. Patients were then reviewed for the use of intraoperative crystalline vancomycin powder. Those with a history of prior surgical site infection, chronic systemic infections or osteomyelitis were excluded. Anhydrous, crystalline vancomycin was utilized in the wound bed after completion of implantation, distributed evenly in the case of multiple incisions. Patients received 500 mg or 1000 mg of crystallized vancomycin, evenly distributed through the wound layers based on a 70 kg weight cutoff. Intraoperative institutional standards of infection prophylaxis were unchanged throughout the study period. Infection rate of baclofen pump placement prior to the use of vancomycin powder from 2001–2009 at the same institution was monitored. Wound infection rate was tracked for a 12 month postoperative period. Six patients out of 26 baclofen pump implantations (23%) in this cohort were identified to have seven infections despite vancomycin powder placement in the lumbar and catheter wounds. Prior infection rates have been investigated for intrathecal drug delivery systems from 2001 to 2009 at the same institution with an overall infection rate of 3% (8/274). The use of vancomycin powder in patients with implants in this series did not reduce infection rates compared to published historical controls, and was elevated compared to institutional controls. Further prospective study of this high risk patient population is warranted.
  • Alberto Esquenazi · Mukul Talaty · Andrew Packel · Michael Saulino
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    ABSTRACT: The aim of this study was to assess the safety and performance of ReWalk in enabling people with paraplegia due to spinal cord injury to carry out routine ambulatory functions. This was an open, noncomparative, nonrandomized study of the safety and performance of the ReWalk powered exoskeleton. All 12 subjects have completed the active intervention; three remain in long-term follow-up. After training, all subjects were able to independently transfer and walk, without human assistance while using the ReWalk, for at least 50 to 100 m continuously, for a period of at least 5 to 10 mins continuously and with velocities ranging from 0.03 to 0.45 m/sec (mean, 0.25 m/sec). Excluding two subjects with considerably reduced walking abilities, average distances and velocities improved significantly. Some subjects reported improvements in pain, bowel and bladder function, and spasticity during the trial. All subjects had strong positive comments regarding the emotional/psychosocial benefits of the use of ReWalk. ReWalk holds considerable potential as a safe ambulatory powered orthosis for motor-complete thoracic-level spinal cord injury patients. Most subjects achieved a level of walking proficiency close to that needed for limited community ambulation. A high degree of performance variability was observed across individuals. Some of this variability was explained by level of injury, but other factors have not been completely identified. Further development and application of this rehabilitation tool to other diagnoses are expected in the future.
    American journal of physical medicine & rehabilitation / Association of Academic Physiatrists 11/2012; 91(11):911-21. DOI:10.1097/PHM.0b013e318269d9a3 · 2.01 Impact Factor
  • Michael Saulino
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    ABSTRACT: SUMMARY Intrathecal therapy involves the subarachnoid delivery of medications where the administered agents have enhanced potency and diminished systemic exposure compared with oral administration. Baclofen exerts its therapeutic action by enhancing the inhibition produced by the endogenous neurotransmitter GABA. While well-established within the armamentarium of tools for spasticity management, the role of intrathecal baclofen for the management of chronic pain is less certain. The purpose of this review is to describe the pharmacology of intrathecal baclofen, relate the role of intrathecal baclofen in neurologic and non-neurologic conditions, and report upon the potential utility of coadministering baclofen with other agents via the intrathecal route of delivery.
    11/2012; 2(6):603-8. DOI:10.2217/pmt.12.60
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    ABSTRACT: Introduction:  The use of intrathecal (IT) infusion of analgesic medications to treat patients with chronic refractory pain has increased since its inception in the 1980s, and the need for clinical research in IT therapy is ongoing. The Polyanalgesic Consensus Conference (PACC) panel of experts convened in 2000, 2003, and 2007 to make recommendations on the rational use of IT analgesics based on preclinical and clinical literature and clinical experiences. Methods:  The PACC panel convened again in 2011 to update the standard of care for IT therapies to reflect current knowledge gleaned from literature and clinical experience. A thorough literature search was performed, and information from this search was provided to panel members. Analysis of published literature was coupled with the clinical experience of panel members to form recommendations regarding the use of IT analgesics to treat chronic pain. Results:  After a review of literature published from 2007 to 2011 and discussions of clinical experience, the panel created updated algorithms for the rational use of IT medications for the treatment of neuropathic pain and nociceptive pain. Conclusions:  The advent of new algorithmic tracks for neuropathic and nociceptive pain is an important step in improving patient care. The panel encourages continued research and development, including the development of new drugs, devices, and safety recommendations to improve the care of patients with chronic pain.
    Neuromodulation 09/2012; 15(5):436-466. DOI:10.1111/j.1525-1403.2012.00476.x · 1.79 Impact Factor
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    ABSTRACT: Introduction:  Targeted intrathecal drug infusion to treat moderate to severe chronic pain has become a standard part of treatment algorithms when more conservative options fail. This therapy is well established in the literature, has shown efficacy, and is an important tool for the treatment of both cancer and noncancer pain; however, it has become clear in recent years that intrathecal drug delivery is associated with risks for serious morbidity and mortality. Methods:  The Polyanalgesic Consensus Conference is a meeting of experienced implanting physicians who strive to improve care in those receiving implantable devices. Employing data generated through an extensive literature search combined with clinical experience, this work group formulated recommendations regarding awareness, education, and mitigation of the morbidity and mortality associated with intrathecal therapy to establish best practices for targeted intrathecal drug delivery systems. Results:  Best practices for improved patient care and outcomes with targeted intrathecal infusion are recommended to minimize the risk of morbidity and mortality. Areas of focus include respiratory depression, infection, granuloma, device-related complications, endocrinopathies, and human error. Specific guidance is given with each of these issues and the general use of the therapy. Conclusions:  Targeted intrathecal drug delivery systems are associated with risks for morbidity and mortality that can be devastating. The panel has given guidance to treating physicians and healthcare providers to reduce the incidence of these problems and to improve outcomes when problems occur.
    Neuromodulation 07/2012; 15(5):467-482. DOI:10.1111/j.1525-1403.2012.00486.x · 1.79 Impact Factor
  • George Miljanich · Richard Rauck · Michael Saulino
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    ABSTRACT:   Chronic pain-especially that which is refractory to conventional treatment-presents particular challenges to physicians and patients. Examination of the molecular and cellular mechanisms involved in this pathophysiology suggests that spinal instillation of therapeutic agents may offer an effective treatment option through the modification of the processing and sensation of chronic pain. Intrathecal therapy, used alone or in combination with other analgesic agents, may reduce chronic pain by attenuating both pre- and postsynaptic activities. This article reviews chronic pain pathophysiology and the mechanisms whereby spinally administered analgesics may modify chronic pain. Available treatment options are also considered, including recommendations from the 2007 Polyanalgesic Consensus Conference (PACC) guidelines on the use of intrathecal agents for nociceptive, neuropathic, and mixed pain.
    Pain Practice 05/2012; 13(2). DOI:10.1111/j.1533-2500.2012.00564.x · 2.18 Impact Factor
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    ABSTRACT: Introduction:  Trialing for intrathecal pump placement is an essential part of the decision-making process in placing a permanent device. In both the United States and the international community, the proper method for trialing is ill defined. Methods:  The Polyanalgesic Consensus Conference (PACC) is a group of well-published experienced practitioners who meet to update the state of care for intrathecal therapies on the basis of current knowledge in the literature and clinical experience. Anexhaustive search is performed to create a base of information that the panel considers when making recommendations for best clinical practices. This literature, coupled with clinical experience, is the basis for recommendations and for identification of gaps in the base of knowledge regarding trialing for intrathecal pump placement. Results:  The panel has made recommendations for the proper methods of trialing for long-term intrathecal drug delivery. Conclusion:  The use of intrathecal drug delivery is an important part of the treatment algorithm for moderate to severe chronic pain. It has become common practice to perform a temporary neuroaxial infusion before permanent device implantation. On the basis of current knowledge, the PACC has developed recommendations to improve care. The need to update these recommendations will be very important as new literature is published.
    Neuromodulation 04/2012; 15(5):420-435. DOI:10.1111/j.1525-1403.2012.00450.x · 1.79 Impact Factor
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    ABSTRACT: Introduction: Continuous intrathecal infusion of drugs to treat chronic pain and spasticity has become a standard part of the algorithm of care. The use of opioids has been associated with noninfectious inflammatory masses at the tip of the intrathecal catheter, which can result in neurologic complications. Methods: The Polyanalgesic Consensus Conference is a meeting of a group of well-published and experienced practitioners; the purpose of the meeting is to update the standard of care for intrathecal therapies to reflect current knowledge gleaned from literature and clinical experience. An exhaustive literature search was performed, and information from this search was provided to panel members. Analysis of the published literature was coupled with the clinical experience of panel participants to form recommendations regarding intrathecal inflammatory masses or granulomas. Results: The panel has made recommendations for the prevention, diagnosis, and management of intrathecal granulomas. Conclusion: The use of chronic infusions of intrathecal opioids is associated with the formation of inflammatory masses at the intrathecal catheter tip in a small minority of treated patients. Nonetheless, the appearance of these space-occupying lesions can lead to devastating neurologic sequelae. The prevention, early detection, and successful treatment of intraspinal granulomas are important considerations when offering intrathecal drug therapy to patients with chronic intractable pain.
    Neuromodulation 04/2012; 15(5):483-496. DOI:10.1111/j.1525-1403.2012.00449.x · 1.79 Impact Factor
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    Michael Saulino · Adam Schreiber · Thomas Watanabe
    PM&R 04/2012; 4(4):304-11. DOI:10.1016/j.pmrj.2012.03.017 · 1.66 Impact Factor
  • Yinn Cher Ooi · Michael Saulino · Kim A Williams · Ashwini Sharan
    PM&R 02/2011; 3(2):175-8. DOI:10.1016/j.pmrj.2010.08.004 · 1.66 Impact Factor
  • M.F. Saulino · S.A. Yablon · E. Mober-Wolf · J.W. Chow · D.S. Stokic
    Spasticity Diagnosis and Management, Edited by Brashear A., Elovic E., 01/2010: pages 229-242; Demos Medical.
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    ABSTRACT: Intrathecal administration of baclofen is a well-established technique for modulating hypertonia secondary to upper motor neuron pathology. Despite the nearly 2 decades of widespread clinical use, this intervention presents many challenges to even experienced clinicians. The purpose of this clinical review is to describe some of the intricacies and subtleties of this treatment strategy. This narrative provides an overview of 3 topics: (1) an alternative methodology for intrathecal baclofen trials; (2) an algorithmic approach to troubleshooting intrathecal delivery systems; and (3) the utility of neurophysiologic assessments within various phases of intrathecal baclofen therapy.
    PM&R 09/2009; 1(9):852-8. DOI:10.1016/j.pmrj.2009.07.015 · 1.66 Impact Factor
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    ABSTRACT: This self-directed learning module highlights approaches to the investigation of selected lumbar spine conditions. It is part of the chapter on chronic pain management in the Self-Directed Physiatric Education Program for practitioners in physical medicine and rehabilitation. The first objective explores the diagnostic evaluation for groin and buttock pain in a 66-year-old man with pain during ambulation. The second objective describes the unique challenges of managing the adolescent with low back pain. OVERALL ARTICLE OBJECTIVE: To review evaluation and management strategies for selected lumbar pain syndromes.
    Archives of physical medicine and rehabilitation 04/2008; 89(3 Suppl 1):S47-50. DOI:10.1016/j.apmr.2007.12.008 · 2.44 Impact Factor
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    ABSTRACT: This self-directed learning module highlights approaches to the investigation of common cervical and thoracic conditions. It is part of the chapter on chronic pain management in the Self-Directed Physiatric Education Program for practitioners in physical medicine and rehabilitation. The differential diagnosis of cervical and thoracic syndromes as well as cervicogenic headache is reviewed. The need for a comprehensive history and physical examination is emphasized. Indications for diagnostic tests including magnetic resonance imaging, computed tomography scan, bone scan, diskography, radiographs, diagnostic injections, and electrodiagnostic studies are discussed with the idea that testing should be performed and interpreted with the specific clinical presentation in mind. OVERALL ARTICLE OBJECTIVE: To discuss the differential diagnoses for and investigation of common cervical and thoracic conditions and cervicogenic headache.
    Archives of physical medicine and rehabilitation 04/2008; 89(3 Suppl 1):S41-6. DOI:10.1016/j.apmr.2007.12.004 · 2.44 Impact Factor

Publication Stats

326 Citations
44.08 Total Impact Points

Institutions

  • 2014
    • Jefferson College
      Хиллсборо, Missouri, United States
  • 2009–2014
    • Thomas Jefferson University
      • Department of Rehabilitation Medicine
      Philadelphia, Pennsylvania, United States
  • 2012
    • Thomas Jefferson University Hospitals
      • Department of Rehabilitation Medicine
      Filadelfia, Pennsylvania, United States
  • 2011
    • Albert Einstein College of Medicine
      New York, New York, United States
  • 2010
    • New York State
      New York City, New York, United States
  • 2007
    • West Virginia University
      MGW, West Virginia, United States