Durable Relief Research Articles

Safety and quality assurance of MR-guided focused ultrasound (MRgFUS) in palliation of painful bone metastases.

9565 Background: Palliation of bone metastases is typically performed with radiation therapy (RT). However, a significant minority of patients cannot obtain durable relief from RT. MRgFUS combines non-invasive focused ultrasound with MR guidance. Preliminary phase III results comparing MRgFUS to sham treatment have demonstrated efficacy. This study examines the safety of this procedure in a large prospective, multi-center study. Methods: Patients with a painful bone metastasis were randomized (3:1) to either MRgFUS or sham treatment for the single most painful lesion. Sham patients were given the opportunity to cross over after 2 weeks. Each adverse event (AE) was recorded prospectively and scored for severity and relation to treatment. Results: Thirty-seven patients were enrolled to receive sham treatment and 115 to receive MRgFUS. Sites of treatment were: 102 pelvis, 28 thorax, 7 lower extremity and 2 upper extremity. Seventy-seven target lesions were osteolytic, 29 were osteoblastic and 33 were mixed. Treatment was discontinued prior to completion in 8 treatments. Of these, 7 were pelvic targets and 6 lesions were osteolytic. The most common reasons for discontinuation were pain (4) and patient movement (2). Forty-seven percent of treatment patients and 2.7% of sham patients reported at least one AE. Of 76 AEs, 67 were considered non-significant and anticipated, 57 being intra-procedure pain. Four significant events included 2 possibly related fractures at treated lytic lesion sites, 1 grade 3 skin burn and 1 patient with neuropathy. Four patients experienced events unrelated to study treatment and 1 patient experienced temporary apnea from anesthesia described as incidental. Conclusions: MRgFUS is a safe treatment for palliation of painful bone metastases. Ninety-three percent of MRgFUS treatments were carried out to completion. Three percent of patients experienced significant AEs, including 2 fractures of treated lytic tumors. These safety data reinforce and confirm previous experience with this technology and encourage its use for patients not suitable for RT. Clinical trial information: NCT00656305.

TRACTION-EXTENDED THERAPY OF PATIENTS WITH LUMBAR DEGENERATIVE DISEASE

Based on the survey of 148 patients with an lumbar degenerative disease, there have been studied immediate and medium-term results of the comprehensive conservative treatment of the patients with and without application of traction exposure on the spine. It was found out that the traction of the spine leads to a quicker and more durable relief of symptoms in comparison with the control groups where traction therapy wasn't carried out. Application of the traction-extended therapy in three planes with a usage of robotized set for dry skeletal traction of a new generation KinetracKNX-7000 is proved to increase the effectiveness of treatment for the patients with stated pathology, fasten regress of the pain syndrome and clinical symptomatology, lead to more durable and lasting remission of the desease, in comparison with the patients that had traction of the spine in one plane only during the treatment.

Simultaneous Unicompartmental Knee Arthroplasty and Lateral Patellar Facetectomy for Bicompartmental Degenerative Disease

ABSTRACT Introduction Unicompartmental knee arthroplasty (UKA) is a treatment option in patients with unicompartmental degenerative disease. Compared to total knee arthroplasty (TKA), the advantages of UKA include accelerated recovery and cruciate ligament retention. These advantages, along with emerging evidence that mild patellofemoral joint osteoarthritis does not compromise results of UKA have encouraged expansion of the indications for UKA. Symptomatic lateral patellofemoral joint degenerative disease is a common cause of UKA revision. Partial lateral patellar facetectomy can provide relief from symptoms of lateral patellofemoral degenerative disease. We hypothesize that simultaneous UKA and lateral patellar facetectomy provides durable pain relief and functional improvement in a patient population with degenerative disease of one tibiofemoral compartment and the lateral patellofemoral joint. Materials and methods: Between 2004 and 2008, 11 lateral UKA's were performed in association with partial lateral patellar facetectomy in 11 female patients (mean age: 66.7 years) with degenerative changes in one tibiofemoral compartment and the lateral patellofemoral joint. Patients were followed clinically and radiographically for a mean of 5 years. Results No patient underwent revision surgery in the followup period. The mean international Knee Society (IKS) knee score improved from 64.9 ± 11.2 points preoperatively to 87.5 ± 12.6 points at final follow-up (p = 0.01). The mean IKS functional score improved from 65.9 ± 23.5 points preoperatively to 83.2 ± 23.3 points at final follow-up (p = 0.012). The mean Kujala score was 84.3 ± 13.5 points postoperatively. Progression of patellofemoral OA was observed in one patient. Conclusion Simultaneous UKA and partial lateral patellar facetectomy is a viable treatment option for symptomatic degenerative disease involving one tibiofemoral compartment and the lateral patellofemoral joint. This treatment approach may be a useful alternative to TKA or bicompartmental arthroplasty in a carefully selected patient population. Level of evidence Case series—Level IV. Magnussen RA, Gancel E, Servien E, Jacobi M, Demey G, Neyret P, Lustig S. Simultaneous Unicompartmental Knee Arthroplasty and Lateral Patellar Facetectomy for Bicompartmental Degenerative Disease. The Duke Orthop J 2013;3(1):61-66.

Is myomectomy always the best choice for infertile women with symptomatic uterine fibroids?

Uterine artery embolization (UAE) is still regarded by most gynaecologists as contraindicated for women with symptomatic fibroids and otherwise unexplained infertility. For such patients, myomectomy is the usual option. We performed UAE as treatment of menorrhagia in an infertile woman with multiple subserosal and intramural fibroids who had previously failed multiple myomectomy. UAE resulted in durable symptom relief and substantial reduction of the uterine and fibroid size. The patient conceived spontaneously 20 months after UAE and progressed through pregnancy uneventfully. At 38 weeks of gestation, she underwent elective cesarean section and delivered a normal, healthy, 3180-g fetus without complications. The present case demonstrates that in symptomatic women with multiple subserosal and intramural fibroids and otherwise unexplained infertility, UAE may have symptomatic and reproductive outcomes superior to those of myomectomy.

Pain control and delay in time to skeletal-related events (SREs) in patients with metastatic castration-resistant prostate cancer (mCRPC) treated with abiraterone acetate (AA): Long-term follow-up.

183 Background: In study COU-AA-301, the androgen biosynthesis inhibitor AA significantly increased overall survival in mCRPC post-docetaxel (D) in both interim and updated analyses at 552 and 775 events, respectively. Interim data also showed a significant benefit of AA on patient (pt) reported pain. We present long-term outcomes of the effect of AA on pain and SREs. Methods: In this international randomized double blind study of AA (1 g QD) + prednisone (P) (5 mg BID) vs placebo + P in mCRPC post-D, pain was assessed at baseline and each treatment cycle until treatment discontinuation using the BPI-SF questionnaire. Palliation/progression of pain intensity (P-INT) and pain interference (P-INF) were evaluated using a priori definitions. P-INT palliation was defined as ≥ 30% improvement in pt reported “worst pain in last 24 h” (on 0-10 numerical rating scale) durable for ≥ 28 d without increased analgesic use (by WHO criteria) in eligible pts (those with significant baseline pain). Conversely, P-INT progression was defined as ≥ 30% deterioration, or increased analgesic use, over ≥ 28 d. Results: 797 pts were randomized to AA + P, 398 to placebo + P. Median follow-up was 20.2 mos. Median time to SRE was 25.0 mos (AA + P) vs 20.3 mos (placebo + P), p = 0.0001. Pain data were available for most patients; the cumulative amount of missing data ranged from 5% at Cycle 1 to 7% at Cycle 20. AA + P improved P-INT outcomes (Table); P-INF benefits were similar and also highly significant. Conclusions: Benefits of AA + P observed in the interim analysis, including superior and more durable pain relief and delay of pain progression and SREs, were maintained with longer follow-up. Additional analyses of the potential relationships between pain/SREs and other outcomes, as well as of prednisone’s effect on pain palliation in the control arm, are ongoing. [Table: see text]

Prospective, double-blind, placebo-controlled trials of ecallantide for acute attacks of hereditary angioedema

Hereditary angioedema (HAE) is a rare genetic disorder characterized by unpredictable, episodic, incapacitating attacks of well-demarcated angioedema in the absence of urticaria and pruritus. HAE is due to deficient or dysfunctional C1-esterase inhibitor activity, which results in unopposed activation of plasma kallikrein, resulting in increased levels of bradykinin. Ecallantide is a potent and specific plasma kallikrein inhibitor approved for the treatment of acute attacks of HAE affecting any anatomic site. In Phase III clinical trials, subcutaneously administered ecallantide demonstrated significant, rapid and durable symptom relief. Ecallantide was effective for all attack types, including potentially life-threatening laryngeal attacks. The main safety concern is potentially serious hypersensitivity reactions, including anaphylaxis. Ecallantide represents an important treatment option for the management of acute attacks of HAE.

Surgery for Chronic Pancreatitis

Chronic pancreatitis (CP) is progressive inflammatory process of the pancreas. Abdominal pain remains the most debilitating symptom affecting quality of life, apart from diabetes mellitus, steatorrhoea and weight loss. The treatment options have evolved over the past decades and are aimed to provide durable relief in pain with possible attempt to support or improve the failing endocrine and exocrine functions. Surgical treatment options have shown the potentials to provide superior long term results compared to the pharmacological and endoscopic modalities and are broadly divided in to drainage, resection and combination hybrid procedures. The choice is based on the morphology of the main pancreatic duct, presence of head mass and associated complication of CP. Knowing the basic nature of the disease, total pancreatectomy seems a curative option but not without significant morbidities. There is recent paradigm shift towards organ sparing surgical procedures with reasonable success. Despite recent advancement in the treatment modalities for CP the overall quality of life remains moderate which need further addressal.

Low-density lipoprotein apheresis is effective in reducing lipoprotein(a) levels and in improving symptoms in a patient with refractory angina secondary to accelerated coronary artery disease

Coronary artery disease remains a significant cause of morbidity and mortality in the Western world. High plasma Lp(a) concentrations are related to the risk of cardiovascular disease, but Lp(a) is rarely assayed and treated. We present the case of a 50-year-old gentleman with refractory angina, whose coronary disease continued to progress despite optimal medical and surgical therapy. We show that the aggressive reduction of Lp(a) successfully ameliorated the progression of coronary stenosis and provides effective and durable relief of symptoms.

Biologic Prosthesis to Prevent Recurrence after Laparoscopic Paraesophageal Hernia Repair: Long-term Follow-up from a Multicenter, Prospective, Randomized Trial

In 2006, we reported results of a randomized trial of laparoscopic paraesophageal hernia repair (LPEHR), comparing primary diaphragm repair (PR) with primary repair buttressed with a biologic prosthesis (small intestinal submucosa [SIS]). The primary endpoint, radiologic hiatal hernia (HH) recurrence, was higher with PR (24%) than with SIS buttressed repair (9%) after 6 months. The second phase of this trial was designed to determine the long-term durability of biologic mesh-buttressed repair. We systematically searched for the 108 patients in phase I of this study to assess current clinical symptoms, quality of life (QOL) and determine ongoing durability of the repair by obtaining a follow-up upper gastrointestinal series (UGI) read by 2 radiologists blinded to treatment received. HH recurrence was defined as the greatest measured vertical height of stomach being at least 2 cm above the diaphragm. At median follow-up of 58 months (range 42 to 78 mo), 10 patients had died, 26 patients were not found, 72 completed clinical follow-up (PR, n = 39; SIS, n = 33), and 60 repeated a UGI (PR, n = 34; SIS, n = 26). There were 20 patients (59%) with recurrent HH in the PR group and 14 patients (54%) with recurrent HH in the SIS group (p = 0.7). There was no statistically significant difference in relevant symptoms or QOL between patients undergoing PR and SIS buttressed repair. There were no strictures, erosions, dysphagia, or other complications related to the use of SIS mesh. LPEHR results in long and durable relief of symptoms and improvement in QOL with PR or SIS. There does not appear to be a higher rate of complications or side effects with biologic mesh, but its benefit in reducing HH recurrence diminishes at long-term follow-up (more than 5 years postoperatively) or earlier.

Uterine artery embolization for symptomatic fibroids: long-term changes in disease-specific symptoms and quality of life

To investigate the long-term changes in health-related quality of life (HRQOL) after uterine artery embolization (UAE) for symptomatic fibroids, we conducted a prospective cohort study. Eighty-two women completed the validated uterine fibroid symptom and QOL (UFS-QOL) questionnaire before UAE. Short-term results after a median of 8 months (range: 3-20) have been published previously. Patients were asked to complete the questionnaire again after a median of 6.3 years (range: 5-7.6). Secondary outcome measures were the frequency of additional surgical or endovascular procedures due to treatment failure and the menstrual status. A total of 4/82 patients (5%) were lost to follow-up. Of the remaining 78 patients, 11 underwent surgery or repeat UAE (hysterectomy n = 6, myomectomy n = 1, UAE n = 4) at a median of 13 months (range: 5-70) after UAE. Two patients failed clinically but did not undergo a second intervention. The overall treatment failure rate 6 years after UAE was 17%. Clinical long-term follow-up regarding symptom control and quality of life was available in the remaining 65 patients. Symptom severity scores decreased from a median of 37.50 (quartile range, QR: 28.13-53.13) to 0.00 (QR: 0.00-10.94) (P < 0.001), whereas the HRQOL total score increased from a median of 64.66 (QR: 46.34-79.10) to 100.00 (QR: 96.12-100.00) (P < 0.001). Both scores also improved significantly compared with short-term results (P = 0.006 and P = 0.041). Permanent amenorrhea was observed in five patients at a median of 18 months (range: 10-46) after UAE and at a mean patient age of 50 years. UAE leads to durable relief of fibroid-related symptoms and sustained improvement in HRQOL. After 6 years, clinical failure can be expected in 17%, and most of these patients require secondary invasive treatment.

Evaluating Clinical Perceptions of a New Medication for Ocular Itch Associated with Allergic Conjunctivitis—Results of the Bepreve® 1.5% First Experience Field Survey

Allergic conjunctivitis associated with seasonal or perennial allergy is an increasingly prevalent complaint. Patients seeking professional evaluation for symptoms of ocular allergy usually have exhausted over-the-counter options and expect rapid, effective relief from the treatment prescribed. With the introduction of Bepreve® (bepotastine besilate ophthalmic solution) 1.5%, a survey of US doctors was conducted to evaluate their opinions and impressions of the medication following the initial patient trial. Responses from 427 practitioners, representing a total of 7,340 patient experiences, suggest that Bepreve is a rapidly effective and comfortable treatment. Nearly all respondents reported being satisfied or very satisfied with the performance of Bepreve. These survey data from the office setting are consistent with clinical trial results demonstrating that Bepreve provides rapid, durable, and comfortable relief of ocular itch.

Current Perspectives on Percutaneous Vertebroplasty: Current Evidence/Controversies, Patient Selection and Assessment, and Technique and Complications

Osteoporotic-associated vertebral compression fractures are a major public health concern, dwarfing even hip fractures in incidence in the United States. These fractures carry a significant morbidity and mortality burden and also represent a major growing source of consumption of scarce heath resources. Percutaneous vertebroplasty remains a commonly used and safe technique for the symptomatic treatment of vertebral compression fractures, both osteoporotic- and neoplastic-induced. By carefully selecting appropriate patients who are referred promptly, vertebroplasty can provide significant and durable pain relief over traditional conservative therapy. Recent controversies surrounding the evidence for vertebroplasty in osteoporotic-associated vertebral compression fractures are reviewed. A comprehensive step-by-step practical guide to performing vertebroplasty is then described. A brief description of patient selection, workup, as well as complications is also provided.

Ocular prostate cancer metastasis treated with external beam radiation.

The purpose of this study was to report a rare case of ocular metastasis from prostate cancer treated successfully with external beam radiation therapy. Case report and literature review. A 60-year-old man with a history of metastatic castration-resistant prostate cancer presented with decreased visual acuity in the right eye. Ophthalmoscopic examination showed a choroidal mass with characteristic surface retinal pigment epithelium spots (leopard spots), consistent with a metastatic tumor. The patient was treated with external beam radiation therapy. He had a dramatic improvement in visual acuity within 4 weeks of completing radiation treatment. Two and half years from radiation treatment to the right eye, he has maintained excellent vision (20/20 with best correction) in spite of systemic disease progression. Uveal metastasis is a rare cause of unexplained blurred vision in the setting of metastatic adenocarcinoma of prostate. Palliative external beam radiotherapy provides effective and durable relief of symptoms during treatment and is generally a well-tolerated regimen with low risk of long-term morbidity.

Acupuncture and Xerostomia

The life of head and neck cancer survivors may be improved by reducing xerostomia (dry mouth). The failure of conventional medicinde to provide durable relief has led toa revival of complementary approaches. This paper is a commentary on a systematic review by O'Sullivan and Higginson into current evidence on whether acupuncture is a safe and useful form of treatment for irradiation-induced zerostomia.

Ultrasound-Guided, Percutaneous Peripheral Nerve Stimulation

Peripheral nerve stimulation is a form of neuromodulation that applies electric current to peripheral nerves to induce stimulation paresthesias within the painful areas. To report a method of ultrasound-guided, percutaneous peripheral nerve stimulation. This technique utilizes real-time imaging to avoid injury to adjacent vascular structures during minimally invasive placement of peripheral nerve stimulator electrodes. We describe a patient that presented with chronic, bilateral foot pain following multiple foot surgeries, for whom a comprehensive, pain management treatment strategy had failed. We utilized ultrasound-guided, percutaneous tibial nerve stimulation at a thigh level to provide durable pain relief on the right side, and open peripheral nerve stimulation on the left. The patient experienced appropriate stimulation paresthesias and excellent pain relief on the plantar aspect of the right foot with the percutaneous electrode. On the left side, we were unable to direct the stimulation paresthesias to the sole of the foot, despite multiple electrode repositionings. A subsequent, open placement of a left tibial nerve stimulator was performed. This revealed that the correct electrode position against the tibial nerve was immediately adjacent to the popliteal artery, and was thus not appropriate for percutaneous placement. We describe a method of ultrasound-guided peripheral nerve stimulation that avoids the invasiveness of electrode placement via an open procedure while providing excellent pain relief. We further describe limitations of the percutaneous approach when navigating close to large blood vessels, a situation more appropriately managed with open peripheral nerve stimulator placement. Ultrasound-guided placement may be considered for patients receiving peripheral nerve stimulators placed within the deep tissues, and not easily placed in a blind fashion.

Elimination of Ischemic Mitral Regurgitation Does Not Alter Long-Term Left Ventricular Remodeling in the Ovine Model

The efficacy of annuloplasty for ischemic mitral regurgitation (IMR) has been difficult to establish. Using an established ovine model of IMR, we tested the ability of ring annuloplasty to durably relieve IMR and reverse or limit progression of left ventricular (LV) remodeling during a clinically relevant follow-up period. A posterolateral infarction known to result in chronic IMR was initiated in 33 sheep. Echocardiography was used to assess LV end diastolic and systolic volumes and IMR (0 to 4 scale) before and 8 weeks after infarction. Eight weeks after infarction, 20 surviving animals with > or = 2+ IMR were randomized (1:1) to no treatment or undersized, semi-rigid, complete ring annuloplasty placement. LV remodeling and IMR were assessed at 4 and 6 months after infarction. All animals had similarly sized LV volumes at baseline (end systolic, 27.8 +/- 4.6 mL; end diastolic, 53.5 +/- 6.4 mL). The 20 randomized animals survived to complete the study. The degree of IMR before randomization was similar in treatment (2.6 +/- 0.4) and control (2.8 +/- 0.3) groups. At the 6-month follow-up, the degree of IMR was significantly less in the annuloplasty group (0.3 +/- 0.1 vs 3.4 +/- 0.6); however, LV volumes in the treatment group were not significantly different from the control group (end systolic, 82.1 +/- 15.6 vs 81.1 +/- 8.6 mL; end diastolic, 110.4 +/- 22.1 vs 111.1 +/- 16.5 mL). In a clinically relevant ovine model of IMR, annuloplasty provides durable relief from IMR during an extended follow-up period but does not significantly influence LV remodeling.

Open dorsal vertebroplasty of the axis

Vertebroplasty of the axis is always a challenging procedure. We report the case of a young, HIV-positive patient suffering from an osteolytic metastasis of the axis. An open dorsal vertebroplasty was performed. A leakage of the cement formed a new cortical bone of the massa lateralis of C2, and stabilized the C1-C2 articulation by an arthrodesis-like effect. Durable pain relief and stabilization were obtained. The location of the cement, although atypical, had all desired effects of a conventional vertebroplasty. The intra-articular injection of cement into the facets for stabilization and pain relief could be considered in the future.

The Use of Stellate Ganglion Block in the Treatment of Panic/Anxiety Symptoms with Combat‐Related Post‐Traumatic Stress Disorder; Preliminary Results of Long‐Term Follow‐Up: A Case Series

Report the successful use of stellate ganglion blocks (SGBs) in two patients experiencing symptoms of post-traumatic stress disorder (PTSD). Successful treatment of PTSD with SGB has been reported previously. A similar protocol was employed at Walter Reed Army Medical Center to treat two soldiers with chronic, combat-related PTSD. Both patients received a SGB on the right side at C6 level. The patients' PTSD symptoms were evaluated using the Post-traumatic Stress Disorder Checklist (PCL). The PCL was administered the day prior to treatment, to establish a baseline, and the day after treatment. The PCL was also utilized during follow-up visits to quantify the patient's symptomotology. The SGB was administered by an anesthesiologist and the psychometric tests administered by a psychologist. Both patients experienced immediate, significant and durable relief as measured by the PCL (score minimum 17, maximum 85). In both instances, the pre-treatment score suggested a PTSD diagnosis whereas the post-treatment scores did not. One patient requested repeat treatment after 3 months, and the post-treatment score remained below the PTSD cutoff after 7 additional months of follow-up. Both patients discontinued all antidepressant and antipsychotic medications while maintaining their improved PCL score. Selective blockade of the right stellate ganglion at C6 level is a safe and minimally invasive procedure that may provide durable relief from PTSD symptoms, allowing the safe discontinuation of psychiatric medications. blacksquare, square, filled.

Laparoscopic Cardiomyotomy for Achalasia: Clinical Outcomes Beyond 5 Years

BackgroundLaparoscopic cardiomyotomy is the most common surgical procedure for the treatment of achalasia, although few reports describe long-term surgical outcomes. MethodsThe outcomes for 155 patients who underwent a laparoscopic cardiomyotomy with anterior partial fundoplication more than 5 years ago (July 1992 to May 2004) were determined. Patients were followed prospectively at yearly time points using a structured questionnaire which evaluated symptoms of dysphagia, reflux, side-effects, and overall satisfaction with the clinical outcome. ResultsClinical data were available for 125 patients. Thirteen patients died within 5 years of surgery, four were unable to complete the questionnaire, and one developed esophageal squamous cell carcinoma. Nine patients were lost to follow-up, and three would not answer the questionnaire (92.2% late follow-up). Postoperative dysphagia, odynophagia, chest pain, and heartburn was significantly improved at 1 year, 5 years, and late (5+ years) follow-up, with outcomes stable beyond 12 months. Seventy-seven percent of patients reported a good or excellent result (minimal or no symptoms) at 5 years and 73% at late follow-up. At late follow-up, 90% considered they had made the correct decision to undergo surgery. ConclusionsAt minimum 5 years follow-up, laparoscopic cardiomyotomy for achalasia achieves effective and durable relief of symptoms, and most patients are satisfied with the outcome.

Pedicled omental split skin graft: A novel method for reconstruction of full-thickness abdominal wall defect

Although rare in children, aggressive fibromatosis or desmoid tumors require wide surgical excision for durable relief. The resultant defect poses many challenges for reconstruction. The authors report reconstruction of such a wound using a pedicled omental split skin graft, which resulted from the excision of a locally recurrent desmoid tumor.