Medicare Guideline posts
In the remaining 85 patients, significant reduction in MR was observed in all evaluated parameters. Mitral regurgitation improvement was an independent prognostic factor for survival hazard ratio 0. The authors concluded that CRT is a potential therapeutic option in HF patients with moderate-severe functional MR and high-risk for surgery.
Stavrakis et al stated that atrio-ventricular junction AVJ ablation with permanent pacing improves symptoms in selected patients with atrial fibrillation AF. The optimal pacing modality after AVJ ablation remains unclear. In a meta-analysis, these investigators examined if CRT is superior to right ventricular RV pacing in this patient population. A total of 5 trials involving patients in CRT and in RV pacing group were included in the analysis. Cardiac resynchronization therapy did not improve 6-min walk distance mean difference Moreover, they stated that further studies, adequately powered to detect clinical outcomes, are needed.
Curtis et al noted that RV pacing restores an adequate heart rate in patients with AV block, but high percentages of RV apical pacing may promote left ventricular systolic dysfunction. These researchers examined if biventricular pacing might reduce mortality, morbidity, and adverse left ventricular re-modeling in such patients.
Patients received a cardiac-resynchronization pacemaker or ICD the latter if the patient had an indication for defibrillation therapy and were randomly assigned to standard RV pacing or biventricular pacing. Of patients enrolled, underwent randomization and were followed for an average of 37 months.
Patients randomly assigned to biventricular pacing had a significantly lower incidence of the primary outcome over time than did those assigned to RV pacing hazard ratio, 0.
Left ventricular lead-related complications occurred in 6. Coburn and Frishman stated that HF is a major cause of morbidity and mortality in the United States; however, reliable biomarkers predicting outcomes of patients suffering from HF are still not available. Finding a prognostic indicator in patients with HF could ultimately help improve the quality of goal-directed care for these patients. A number of recent studies suggested that galectin-3, a peptide that has been repeatedly shown to be elevated in the setting of inflammatory processes, may provide information regarding the pathophysiologic process underlying HF.
If this is the case, galectin-3 may independently be able to provide more information regarding prognosis in patients with HF than some of the more conventional indicators currently in use today i. These researchers analyzed the most recent and comprehensive studies that have looked at the utility of galectin-3 as a prognostic marker in patients with HF.
After a thorough review, they found that the evidence against the use of galectin-3 as a prognostic biomarker in HF was too strong to support its routine use in current clinical settings. However, many of the studies, both in support of and in opposition to the prognostic potential of galectin-3, were uniformly limited by undersized cohorts, and thus the need for further exploration is clearly warranted.
Atabakhshian et al examined the relationship between galectin-3 as a biomarker and ejection fraction and functional capacity in the patients with compensated systolic HF. Besides, echocardiography was used to evaluate LVEF. Additionally, functional capacity was determined based on the patients' ability to perform a set of activities. The patients' age ranged from 45 to 75 years, with the mean age of The results revealed no significant correlation between galectin-3 and age, body mass index, and estimated glomerular filtration rate eGFR.
The authors concluded that the findings of this study suggested that galectin-3 could not be used as a marker of disease progression in the patients under treatment, which could probably be the result of medication use in these patients.
Biomarkers for prognosticating patients with HF have generated immense interest. Several studies have been conducted on a novel biomarker, galectin-3 to assess its prognostic effect in HF populations.
However, the studies have generated conflicting results. These investigators performed a systematic review to assess the utility of galectin-3 as a prognostic biomarker in HF. A total of 27 original articles were selected for the systematic review.
However the combination of natriuretic peptides and galectin-3 has been observed to be superior in predicting mortality compared to either of the biomarkers alone. The role of galectin-3 in re-modelling has not been conclusively proven as seen in earlier pre-clinical studies. The authors concluded that the current weight of evidence does not suggest galectin-3 to be a predictor of mortality.
However, assessment of galectin-3 in a multi-biomarker panel may have a distinct advantage in prognosticating patients with HF. The search terms included CRT, QRS duration, narrow QRS, clinical trial, RCT, biventricular pacing, heart failure, systolic dysfunction, dyssynchrony, left ventricular remodeling, readmission, mortality, survival, and various combinations of these terms. The authors studied the trends of overall mortality, SHF mortality, and hospitalizations due to SHF between the 2 groups.
Heterogeneity of the studies was analyzed by Q statistic. The median follow-up was 12 months and the cumulative number of patients was 1, Relative risk for all-cause mortality in patients treated with CRTD was 1.
Friedman and associates noted that patients with moderate-to-severe chronic kidney disease CKD are poorly represented in clinical trials of CRT.
Outcomes were obtained via Medicare claims and censored at 3 years. The primary end-point of HF hospitalization or death and the secondary end-point of death were assessed with Cox proportional hazards models; HF hospitalization, device explant, and progression to end-stage renal disease were assessed using Fine-Gray models. The incidence of in-hospital, short-term, and mid-term device-related complications did not vary across CKD stages.
The authors concluded that in a nationally representative population of HF and CRT-eligible patients, use of CRT-D was associated with a significantly lower risk of the composite end-point of HF hospitalization or death among patients with moderate-to-severe CKD in the setting of acceptable complication rates. Paired investigators independently screened search results to assess eligibility.
For inclusion, investigators abstracted data sequentially and assessed risk of bias independently. Investigators graded the strength of evidence as a group.
They identified 13, unique citations of which 11, were excluded during the abstract screen. During the full-text screening, these researchers excluded 1, citations. There was insufficient evidence to determine predictors of outcomes in patients undergoing CRT-P. This guideline outlines indications for cardiac resynchronization therapy: Hospitalizations for HF were reduced 37 percent, and all-cause mortality was reduced 22 percent, primarily because of a lower risk of HF-related death RR 0.
Multivariable-adjusted subgroup analysis by QRS duration showed that patients from the lower quartile QRS duration group less than or equal to ms experienced 2.
However, the long-term benefits are variable. These researchers performed a meta-analysis of randomized trials identified in systematic searches of Medline, Embase, and the Cochrane Database. A total of 3 studies 3, patients with a mean follow-up of 66 months were included.
However, the risk of cardiac mortality was comparable between 2 groups OR, 0. However, long-term risk of cardiac mortality was similar between 2 groups. Gianni and colleagues stated that although CRT is an important treatment of symptomatic HF patients in sinus rhythm with low LVEF and ventricular dyssynchrony, its role is not well-defined in patients with AF.
The authors stated that CRT is not as effective in patients with AF because of inadequate biventricular capture and loss of AV synchrony.
Both can be addressed with catheter ablation of AF. It is still unclear if these therapies offer additive benefits in patients with ventricular dyssynchrony. Moreover, they stated that further studies are necessary to elucidate the role played by each component of the combined therapy in achieving these results.
Marx stated that PRP remains the only effective growth factor preparation available to oral and maxillofacial surgeons as well as other dental specialists for outpatient use. In contrast, Freymiller and Aghaloo stated: However, at this early stage of investigation, the results are inconclusive.
There is still much to learn regarding PRP before this adjunctive material should be considered for routine use.
Unfortunately, this has not been the case because an entire industry has developed to manufacture the equipment and supplies needed for surgeons to prepare PRP in the office or operating room. Considering the meager volume and contradictory nature of the currently available evidence, there appears to be a disproportionate use of PRP in clinical practice.
These conclusions are in agreement with the observations of Sanchez et al and Grageda This novel and potentially promising technique requires well-designed, controlled trials to provide evidence of effectiveness. There have been different protocols as well as different types of clinical cases.
Without the standardization of these protocols, it will be extremely difficult to ascertain whether PRP enhances bone healing when it is used alone or in conjunction with bone grafting materials. A systematic evidence review of surgical techniques for placing dental implants prepared for the Cochrane Collaboration Coulthard et al, concluded that there is no strong evidence that the use of PRP or other variations in surgical technique described in the review for placing implants have superior success rates.
Recent studies also produced contradictory findings on the clinical value of PRP. These findings are in agreement with the observation of Raghoebard et al who noted that no beneficial effect of PRP on wound healing and bone remodeling of autologous bone grafts used for augmentation of the floor of the maxillary sinus.
In a review on the role of PRP in sinus augmentation, Boyapati and Wang stated that although the lateral wall sinus lift is a predictable clinical procedure to increase vertical bone height resulting in implant success rates comparable to that of native bone, the issue of extended healing periods remains troublesome.
Clinicians and researchers have investigated several methods, including addition of growth factors and peptides, to reduce this healing time and enhance bone formation within the subantral environment. Platelet-rich plasma is an autologous blood product containing high concentrations of several growth factors and adhesive glycoproteins. The incorporation of PRP into the sinus graft has been proposed as a method to shorten healing time, enhance wound healing, and improve bone quality.
These investigators noted that currently, the literature is conflicting with respect to the adjunctive use of PRP in sinus augmentation. In addition, methods of quantifying bone regeneration and wound healing differ between studies. Currently, because of limited scientific evidence, the adjunctive use of PRP in sinus augmentation cannot be recommended. The authors stated that further prospective clinical studies are urgently needed.
In a randomized controlled trial, de Vos et al examined if a PRP injection would improve outcome in chronic mid-portion Achilles tendinopathy. A stratified, block-randomized, double-blind, placebo-controlled study at a single center of 54 randomized patients aged 18 to 70 years with chronic tendinopathy 2 to 7 cm above the Achilles tendon insertion were carried out.
The trial was conducted between August 28, , and January 29, , with follow-up until July 16, Subjects received eccentric exercises usual care with either a PRP injection PRP group or saline injection placebo group. Randomization was stratified by activity level. Main outcome measure was the validated Victorian Institute of Sports Assessment-Achilles VISA-A questionnaire, which evaluated pain score and activity level; and was completed at baseline and 6, 12, and 24 weeks.
The VISA-A score ranged from 0 to , with higher scores corresponding with less pain and increased activity. Treatment group effects were evaluated using general linear models on the basis of intention-to-treat. The increase was not significantly different between both groups adjusted between-group difference from baseline to 24 weeks, The authors concluded that among patients with chronic Achilles tendinopathy who were treated with eccentric exercises, a PRP injection compared with a saline injection did not result in greater improvement in pain and activity.
Consequently, CMS issued a non-coverage determination for acute surgical wounds when the autologous PRP is applied directly to the closed incision and for dehiscent wounds. CMS also maintained the current non-coverage for chronic, non-healing cutaneous wounds. In the complete healing process of chronic skin ulcers, the results are inconclusive. There are little data regarding the safety of PRP. There are several methodological limitations and, consequently, future research should focus on strong and well-designed RCTs that evaluate the safety and effectiveness of PRP.
An assessment by the Institute for Clinical Effectiveness and Health Policy IECS, concluded that, "although in vitro, PRP has demonstrated to release growth factors and to improve tendon structure, so far, there is no evidence supporting its use in human beings. The rotator cuff is comprised of four muscles i. The tendons of these muscles form a single tendon unit, which inserts onto the greater tuberosity of the humerus. The rotator cuff helps to lift and rotate the arm as well as to stabilize the ball of the shoulder within the joint.
Tears of the rotator cuff tendons are one of the most common causes of pain, loss of motion, and disability in adults. Traditional treatments include conservative interventions e. Following rotator cuff repair surgery, the arm is immobilized to allow the tear to heal. The length of immobilization is usually dependent on the severity of the tear. Recent developments in rotator cuff repair surgery include newer arthroscopic and mini-open surgical techniques.
These new techniques are intended to allow for smaller, less painful incisions and faster recovery time. Many of these advances use dissolvable anchors, which hold sutures in place or hold sutures down to bone until the repair has healed and then are absorbed by the body. There is also ongoing research on orthobiologic tissue implants that is intended to enhance healing and promote growth of new tissue. The implant is manufactured from 10 layers of small intestine submucosa derived from porcine small intestine and is mainly composed of water and collagen.
According to the FDA, this surgical mesh implant is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists. The device is intended to act as a resorbable scaffold that initially has sufficient strength to assist with a soft tissue repair, but then resorbs and is replaced by the patient's own tissue. In addition, the implant is intended for use in the specific application of reinforcement of the soft tissues, which are repaired by suture or suture anchors, limited to the supraspinatus, during rotator cuff surgery.
According to the manufacturer, this surgical mesh implant is intended to give the surgeon a less invasive treatment when the rotator cuff tissue is of poor quality or the repair needs reinforcement. Although the Restore orthobiologic implant has been cleared by the FDA for marketing, there is a lack of adequate evidence on the effectiveness of this implant in rotator cuff repair.
Malcarney et al presented a case series of 25 patients who underwent rotator cuff repair by one surgeon using this implant to augment the repaired tendon or fill a defect. All patients underwent open irrigation and debridement of the rotator cuff and the implant. The authors concluded that these porcine surgical mesh implants should be used with caution and with the understanding that an early post-operative non-specific inflammatory reaction can occur that may cause breakdown of the repair.
Furthermore, these investigators stated that more studies are needed to further characterize the reaction and determine which patients are susceptible. Zheng et al stated that the small intestinal submucosa SIS that is used in this implant is not an acellular collagenous matrix, and contains porcine DNA.
They suggested that further studies should be conducted to evaluate the clinical safety and effectiveness of SIS implant biomaterials. The most frequent side effects encountered in soft tissue repair include infection, adhesions, sterile effusion, instability, increased stiffness post-operatively, and general risks associated with surgery and anesthesia such as neurological, cardiac, and respiratory deficit.
Potential device-related risks include stretching or tearing of the device, stiffness, chronic synovitis or effusion, prolonged post-operative rehabilitation, delayed or failed incorporation of the device as well as immunological reaction.
Moreover, the porcine surgical mesh implant is contraindicated in patients with massive chronic rotator cuff tears that cannot be mobilized, or where the muscle tissue has undergone substantial fatty degeneration. Fibrin glue has been used to treat anorectal fistulas in an attempt to avoid more radical surgical intervention. Fibrin glue treatment is simple and repeatable; failure does not compromise further treatment options; and sphincter function is preserved.
However, reported success rates vary widely. Suturable bioprosthetic plugs Surgisis, Cook Surgical, Inc. Surgisis is a new 4- or 8-ply bioactive, prosthetic mesh for hernia repair derived from porcine SIS.
In a review on resorbable extra-cellular matrix grafts in urological reconstruction, Santucci and Barber noted that recent problems with inflammation following 8-ply pubo-vaginal sling use and failures after 1- and 4-ply SIS repair of Peyronie's disease underscore the need for research before wide adoption. In a prospective cohort study, Johnson and Armstrong compared fibrin glue versus the anal fistula plug.
Patients with high trans-sphincteric fistulas, or deeper, were prospectively enrolled. Patients with Crohn's disease or superficial fistulas were excluded. Age, gender, number and type of fistula tracts, and previous fistula surgeries were compared between groups. Under general anesthesia and in prone jack-knife position, the tract was irrigated with hydrogen peroxide.
Fistula tracts were occluded by fibrin glue versus closure of the primary opening using a Surgisis anal fistula plug. A total of 25 patients were prospectively enrolled: Patient's age, gender, fistula tract characteristics, and number of previous closure attempts was similar in both groups.
The authors concluded that closure of the primary opening of a fistula tract using a suturable biologic anal fistula plug is an effective method of treating anorectal fistulas. The method seems to be more reliable than fibrin glue closure. The greater efficacy of the fistula plug may be the result of the ability to suture the plug in the primary opening, therefore, closing the primary opening more effectively. These investigators noted that further prospective, long-term studies are warranted.
The NICE assessment concluded: However, evidence on the efficacy of the procedure is not adequate for it to be used without special arrangements for consent and for audit or research. All patients with peri-anal Crohn's disease suffering from trans-sphincteric and recto-vaginal fistulas who underwent surgery using the Surgisis R anal fistula plug or the Surgisis R mesh were prospectively enrolled in this study.
Inclusion criteria included trans-sphincteric single-tract fistulas and recto-vaginal fistulas. Success was defined as closure of both internal and external peri-anal or vaginal openings, absence of drainage without further intervention, and absence of abscess formation. Follow-up information was obtained from clinical examination 3, 6, 9, and 12 months post-operatively. Within the observation period, a total of 16 procedures were performed. All 4 patients with failure had re-operation.
No deterioration of continence was documented. The authors concluded that the short-term success rates are promising; further analysis is needed to explain the definite role of this technique in comparison with traditional surgical techniques.
Safar et al analyzed the efficacy of the Cook Surgisis AFP anal fistula plug for the management of complex anal fistulas. Patient's demographics, fistula etiology, and success rates were recorded. The plug was placed in accordance with the inventor's guidelines. Success was defined as closure of all external openings, absence of drainage without further intervention, and absence of abscess formation.
A total of 35 patients underwent 39 plug insertions 22 men; mean age of 46 range of 15 to 79 years. Three patients were lost to follow-up, therefore, 36 procedures to be analyzed. The fistula etiology was crypto-glandular in 31 There were 11 smokers and 3 patients with diabetes.
The overall success rate was 5 of 36 In 17 patients, further procedures were necessary as a result of failure of treatment with the plug.
The reasons for failure were infection requiring drainage and seton placement in 8 patients The authors concluded that the success rate for Surgisis AFP anal fistula plug for the treatment of complex anal fistulas was They stated that further analysis is needed to explain significant differences in outcomes. Autologous Iliac Crest Bone Grafting ICBG is considered the gold-standard graft choice for spinal arthrodesis; however, it is associated with donor site morbidity and a limited graft supply.
There is some evidence for the use of demineralized bone matrix products in spinal fusions as an alternative to allograft. A total of patients underwent posterolateral spine fusion with pedicle screw fixation and bone grafting. An independent, blinded reviewer evaluated anteroposterior and lateral flexion-extension radiographs. The fusion mass lateral to the instrumentation on each side was judged fused or not, and the mineralization of the graft was rated absent, mild, moderate, or extensive.
The degree of correspondence in outcomes between sides was estimated by computing the percentage agreement and kappa statistic. Bone mineralization ratings also were similar between treated sides. Consequently, a reduced amount of harvested autograft may be required, potentially diminishing the risk and severity of donor site complications. Forty-six patients were randomly assigned 2: An independent radiologist evaluated plain radiographs and computed tomographic scans at 6-month, 1-year, and 2-year time points.
Similar improvements in the physical component summary scores were seen in both the Grafton and ICBG groups. The authors found that demineralized bone matrix has been evaluated in animal models and human clinical trials of spine fusion. The majority of human clinical trials report high fusion rates when DBM is employed as a graft extender or a graft enhancer. The authors found that few prospective randomized controlled trials have been performed comparing DBM to autologous iliac crest bone graft in spine fusion.
The authors concluded that, although many animal and human studies demonstrate comparable efficacy of DBM when combined with autograft or compared to autograft alone, additional high level of evidence studies are required to clearly define the indications for its use in spine fusion surgeries and the appropriate patient population that will benefit from DBM.
It is injected into osseous defects that are created surgically or as a result of trauma. The paste cures in-situ, resorbs, and then is replaced with bone during the healing process. The cured paste provides a temporary support media for bone fragments during the surgical procedure but does not provide structural support during the healing process.
Injection of MIIG is usually performed in conjunction with another procedure, such as reduction of a fracture. Minimally invasive injectable graft was cleared by the FDA through the k process since it is substantially equivalent to other bone void fillers on the market. Combined with bone marrow aspirate, Integra Mozaik OS is intended for use as a bone void filler of the skeletal system in the extremities, spine,and pelvis. Integra Mozaik OS putty was cleared by the FDA through the k process since it is substantially equivalent to another bone void filler on the market.
According to the FDA k letter to the manufacturer, it is specifically indicated for use in the treatment of surgically treated osseous defects or osseous defects created from traumatic injury to the bone.
Following placement in the body void or gap defect , Integra Mozaik putty is resorbed and replaced with bone during the healing process. Furthermore, a technology assessment prepared by ECRI for Agency for Healthcare Research and Quality concluded that there is no reliable evidence to support the use of calcium sulphate or other bone void fillers as treatments for delayed fracture healing. The publication did not report prior treatment or the duration of the nonunions prior to the AlloMatrix putty treatment.
A technology assessment prepared by the ECRI Institute Schoelles et al, for the Agency for Healthcare Research and Quality, commenting on this study, stated that "[w]ithout this information, interpretation of the results is difficult". The study also did not report whether all consecutively treated patients were included or if dropouts occurred during the treatment period.
A subsequent study by Ziran and colleagues reported on an unacceptably high rate of complications with the use of Allomatrix for nonunions. Patients were monitored for healing and adverse effects, which included local or systemic reactions, wound problems, infection, and any secondary surgery caused by graft complications.
Eleven patients with deep infections also required surgical treatment of drainage. Other analyses were not performed because of the small sample size, which was because of early termination of the study. The investigators concluded that the use of Allomatrix putty as an alternative for autogenous bone graft in the treatment of nonunions resulted in an unacceptably high rate of complications.
Mesenchymal stem cells or MSCs are multipotent stem cells that can differentiate into a variety of cell types. Mesenchymal stem cells have been classically obtained from the bone marrow, and have been shown to differentiate into various cell types, including osteoblasts, chondrocytes, myocytes, adipocytes, and neuronal cells.
Helm and colleagues stated that although autologous bone remains the gold standard for stimulating bone repair and regeneration, the advent in molecular biology as well as bioengineering techniques has produced materials that exhibit potent osteogenic activities. Recombinant human osteogenic growth factors e. They noted that the delivery of MSCs, derived from adult bone marrow, to regions requiring bone formation is also compelling, and it has been shown to be successful in inducing osteogenesis in many pre-clinical animal studies.
Finally, the identification of biological and non-biological scaffolding materials is a crucial component of future bone graft substitutes, not only as a delivery vehicle for bone growth factors and MSCs, but also as an osteo-conductive matrix to stimulate bone deposition directly.
Recently, MSCs has been studied for its use in orthopedic application e. Acosta et al noted that although important obstacles to the survival and proliferation of MSCs within the degenerating intervertebral disc need to be overcome, the potential for this therapy to slow or reverse the degenerative process remains substantial. Leung et al stated that in the past several years, significant progress has been made in the field of stem cell regeneration of the intervertebral disc.
Autogenic MSCs in animal models can arrest intervertebral disc degeneration or even partially regenerate it, and the effect is suggested to be dependent on the severity of degeneration. Mesenchymal stem cells are able to escape alloantigen recognition which is an advantage for allogenic transplantation.
A number of injectable scaffolds have been described and various methods to pre-modulate MSCs' activity have been tested.
They noted that more work is needed to address the use of MSCs in large animal models as well as the fate of the implanted MSCs, especially the long-term outcomes. Mclain et al noted that successful arthrodesis in challenging clinical scenarios is facilitated when the site is augmented with autograft bone.
The iliac crest has long been the preferred source of autograft material, but graft harvest is associated with frequent complications and pain. Connective tissue progenitor cells aspirated from the iliac crest and concentrated with allograft matrix and demineralized bone matrix provide a promising alternative to traditional autograft harvest. The vertebral body, an even larger reservoir of myeloproliferative cells, should provide progenitor cell concentrations similar to those of the iliac crest.
Aspirates were obtained from two depths within the vertebral body and were quantified relative to matched, bilateral aspirates from the iliac crest that were obtained from the same patient at the same time. Histochemical analysis was used to determine the prevalence of vertebral progenitor cells relative to the depth of aspiration, the vertebral level, age, and gender, as compared with the iliac crest standard. Aspirates of vertebral marrow demonstrated comparable or greater concentrations of progenitor cells compared with matched controls from the iliac crest.
With the numbers available, there were no significant differences relative to vertebral body level, the side aspirated, the depth of aspiration, or gender. An age-related decline in cellularity was suggested for the iliac crest aspirates.
The authors concluded that the vertebral body is a suitable site for aspiration of bone marrow for graft augmentation during spinal arthrodesis. They also stated that future clinical studies will attempt to confirm the ability to obtain fusion using only this source of connective tissue progenitor cells.
Anderson and colleagues reviewed the rationale and discussed the results of cellular strategies that have been proposed or investigated for disc degeneration. These investigators noted that although substantial work remains, the future of cellular therapies for symptomatic disc degeneration appears promising. They concluded that continued research is warranted to further define the optimal cell type, scaffolds, and adjuvants that will allow successful disc repair in human patients.
Risbud and colleagues evaluated the osteogenic potential of MSCs isolated from the bone marrow of the human vertebral body VB. Marrow samples from VB of patients undergoing lumbar spinal surgery were collected; marrow was also harvested from the iliac crest IC. Progenitor cells were isolated and the number of colony forming unit-fibroblastic CFU-F determined. The osteogenic potential of the cells was characterized using biochemical and molecular biology techniques.
Moreover, progenitor cells from the VB exhibited an increased level of alkaline phosphatase activity. VB and IC cells mineralized their extracellular matrix to a similar extent. Progenitor cells isolated from both sites respond in a similar manner to an osteogenic stimulus and express common immunophenotypes. Based on these findings, these researchers proposed that progenitor cells from the lumbar vertebral marrow would be suitable candidate for osseous graft supplementation in spinal fusion procedures.
They stated that studies must now be conducted using animal models to ascertain if cells of the VB are as effective as those of the IC for the fusion applications. This technique may yield a more consistent quality of fusion bone as compared to that with autograft.
They stated that these results are encouraging and warrant further studies with the suitable dose of BMP-2 and basic FGF, and may provide a rational basis for their clinical application. AlloStem is partially demineralized allograft bone combined with adipose derived mesenchymal stem cells; it is similar to autograft bone.
Neman et al noted that arthrodesis is a critical component of spine surgery for both degenerative and oncologic pathologies, with durable clinical benefits requiring successful bony fusion. The gold standard for bone grafting remains the autograft, optimally from the iliac crest.
However, the effectiveness of an autograft varies due to the inconsistent quality of the bone procured as well as risks of donor site morbidity. Several technologies exist as alternatives to autograft, either as a graft extender or replacement. Alternatively, stem cells have become increasingly popular as cell-based therapeutics for musculoskeletal applications. Mesenchymal stem cells MSCs have been obtained from adipose tissue, bone marrow, peripheral blood, and synovial fluid, then combined with various osteo-conductive scaffolds.
The rationale for their use is to add an osteogenic component to enhance formation of new bone via differentiation into osteoblasts. However, despite the appeal of this approach, there is a paucity of data supporting the efficacy of using stem cells in a clinical setting for spinal surgery.
Furthermore, the best method for incorporating this technology into spinal surgery has not yet been determined. One approach has been to process an allograft such that endogenous progenitor cells are retained during the processing of freshly procured cadaveric bone.
This approach has the advantage that cells potentially benefit from micro-environmental cues derived from maintaining their attachment to the native cancellous bone scaffold. Indeed, signaling in terms of chemical and mechanical cues between the cell and its scaffold is critically important for new bone formation.
While cellularized allografts are known to harbor endogenous cells, the identity of these cells remains obscure, largely due to the lack of bona fide markers for stem and progenitor cells. In this study, these investigators hypothesized that a cellular allograft bone matrix Osteocel Plus contains a population of mesenchymal stem and bone progenitor cells, the former capable of self-renewal and multi-lineage differentiation.
Currently, no single cell marker can unequivocally distinguish stem cells from progenitor cells. The use of cell surface marker combinations allows for enrichment of the stem cell population but is inadequate for prospective isolation. A novel use of lineage mapping allowed identification of highly proliferative clones and permitted us to determine whether cells endogenous to a cellular allograft undergo extensive self-renewal-a functional hallmark of stem cells. Further, these researchers used genetic and proteomic profiling as well as functional assays to examine whether these cells in the Osteocel Plus allograft are capable of multi-potential differentiation the second functional hallmark of stem cells.
They postulated that the use of these 2 functional hallmarks could enable us to establish corroborative evidence for the existence of a stem and progenitor cell population in cellular allografts. In-vivo investigation is constrained to the use of small immune- deficient animals, because cellular allografts have retained human cells that would be rejected in immune-competent models. Small animal models, such as rodents, have limited translation to human biology.
In a prospective, multi-center, non-randomized, institutional review board-approved clinical and radiographic study, Eastlack et al evaluated and summarized the 2-year outcomes of patients treated with Osteocel Plus cellular allograft as part of an anterior cervical discectomy and fusion procedure.
A total of patients were treated with anterior cervical discectomy and fusion using Osteocel Plus in a PEEK polyetheretherketone cage and anterior plating at 1 or 2 consecutive levels. Clinical outcomes included visual analog scale VAS for neck and arm pain, neck disability index, and SF physical and mental component scores. Computed tomography and plain film radiographic measures included assessment of bridging bone, disc height, disc angle, and segmental range of motion ROM.
A total of levels were treated in patients. No patient required revision for pseudarthrosis. The authors concluded that improvements in clinical results at 2 years, high patient satisfaction, and high radiographic and clinical fusion rates provided confidence in Osteocel Plus as an effective alternative to structural allograft or autograft in anterior cervical discectomy and fusion procedures. These findings need to be confirmed in well-designed randomized controlled trials with longer follow-up periods.
Hankemeier et al noted that the optimal operative therapy for the treatment of osteochondritis dissecans tali is still controversial. Beside bone marrow-stimulating techniques like abrasion arthroplasty, drilling and microfracturing, new techniques like autologous osteochondral transplantation and autologous chondrocyte transplantation are increasingly used.
This study reviewed the clinical, radiological and subjective long-term outcome of bone marrow-stimulating therapy for 45 ankles with an osteochondritis dissecans tali stage 3 or 4 according to the classification by Berndt and Harty. All ankles were treated by the removal of the dissecate and abrasion of the subchondral bone.
The average maximum size of the lesion was 1. At follow-up examination, Obesity, age older than 40 years and pre-operative osteoarthritic changes had a significant negative impact on the clinical outcome.
Autologous chondrocyte transplantation and osteochondral autografts yield encouraging 2- and 4-year results, but still have to prove their superiority in long-term follow-up studies.
Kon et al stated that osteochondritis dissecans is a relatively common cause of knee pain. These researchers described the outcomes of five different surgical techniques in a series of 60 patients with osteochondritis dissecans.
Sixty patients aged The global mean IKDC score improved from No influence of age, lesion size, duration of follow-up, or previous surgical procedures on the result was found. The authors concluded that all of the techniques were effective in achieving good clinical and radiographic results in patients with osteochondritis dissecans, and the effectiveness of autologous chondrocyte implantation was confirmed at a mean follow-up of 5 years.
Newer techniques such as MaioRegen implantation and the "1-step" transplantation technique are based on different rationales; the first relies on the characteristics of the scaffold and the second on the regenerative potential of mesenchymal cells.
Both of these newer procedures have the advantage of being minimally invasive and requiring a single operation. Further investigation is needed to study the value of MSC therapy in orthopedic applications before it can be used in the clinical setting. Cheng et al had previously isolated and identified stem cells from human anterior cruciate ligament ACL.
The purpose of this study was to evaluate the differences in proliferation, differentiation, and extracellular matrix ECM formation abilities between bone marrow stem cells BMSCs and ACL-derived stem cells LSCs from the same donors when cultured with different growth factors, including basic fibroblast growth factor bFGF , epidermal growth factor, and transforming growth factor-beta 1 TGF-beta1.
Ligament tissues and bone marrow aspirate were obtained from patients undergoing total knee arthroplasty and ACL reconstruction surgeries. Proliferation, colony formation, and population doubling capacity as well as multi-lineage differentiation potentials of LSCs and BMSCs were compared. Gene expression and ECM production for ligament engineering were also evaluated.
It was found that BMSCs possessed better osteogenic differentiation potential than LSCs, while similar adipogenic and chondrogenic differentiation abilities were observed.
Steinert et al noted that when ruptured, the ACL of the human knee has limited regenerative potential. However, the goal of this report was to show that the cells that migrate out of the human ACL constitute a rich population of progenitor cells and these researchers hypothesized that they display mesenchymal stem cell MSC characteristics when compared with adherent cells derived from bone marrow or collagenase digests from ACL.
Staining for STRO-1 was seen by immunohistochemistry but not flow cytometry. Under suitable culture conditions, the ACL outgrowth-derived MSCs differentiated into chondrocytes, osteoblasts, and adipocytes and showed capacity to self-renew in an in vitro assay of ligamentogenesis. MSCs derived from collagenase digests of ACL tissue and human bone marrow were analyzed in parallel and displayed similar, but not identical, properties. In situ staining of the ACL suggests that the MSCs reside both aligned with the collagenous matrix of the ligament and adjacent to small blood vessels.
The authors concluded that the cells that emigrate from damaged ACLs are MSCs and that they have the potential to provide the basis for a superior, biological repair of this ligament.
According to information from the manufacturer, BIO MatrX Structure is a highly porous, synthetic bone graft substitute that sets hard upon implantation for a complete defect fill. The manufacturer states that the resulting osteoconductive scaffold provides inter-connected porosity and high surface area to facilitate cell mediated remodeling and new bone growth.
The viscous putty sets hard after closure providing an osteoconductive scaffold to facilitate new bone growth. The manufacturer states that both materials are FDA-cleared to be hydrated with saline or blood; and are indicated as bone void fillers of the pelvis, extremities and the postero-lateral spine.
If a covered diagnosis is not on the claim, the edit will automatically deny the service as not medically necessary. Malignant hypertensive heart disease with heart failure. Benign hypertensive heart disease with heart failure. Unspecified hypertensive heart disease with heart failure. Hypertensive heart and chronic kidney disease, malignant.
Hypertensive heart and chronic kidney disease, benign. Hypertensive heart and chronic kidney disease, unspecified. Acute myocardial infarction of anterolateral wall. Acute myocardial infarction of other anterior wall. Acute myocardial infarction of inferolateral wall. Acute myocardial infarction of inferoposterior wall. Acute myocardial infarction of other inferior wall. Acute myocardial infarction of other lateral wall.
True posterior wall infarction. Acute myocardial infarction of other specified sites. Acute myocardial infarction of unspecified site. Other specified forms of chronic ischemic heart disease.
Ventricular fibrillation and flutter. Other specified cardiac dysrhythmias. Congestive heart failure unspecified. Combined systolic and diastolic heart failure. Other specified congenital anomalies of heart. Mechanical complication due to AICD.