Vertebral Candidiasis, the State of the Art: A Systematic Literature Review.

OBJECTIVE: In recent years, Candida spondylodiscitis has represented an increasingly emerging disease in clinical practice. This condition requires long-term antibiotic therapy and sometimes surgical treatments. The main purpose of this study is to investigate the epidemiology, clinical and radiological aspects, treatment protocols, and outcomes of Candida-mediated vertebral osteomyelitis. METHODS: A systematic review of the English literature was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines.The research was conducted on Medline, Cochrane library, PubMed, and Scopus using as search terms "vertebral"; "spinal"; "infection"; "spondylodiscitis"; "discitis"; "osteomyelitis"; "Candida"; and "Candidosis." A case of vertebral candidiasis that was surgically managed was also reported. RESULTS: In total, 88 articles were included in our systematic review. Including the reported case, our analysis covered 113 cases of vertebral candidiasis. Candida albicans was isolated in 64 cases (56.1%), Candida tropicalis in 21 (18.4%), Candida glabrata in 14 (12.3%), and Candida parapsilosis in five (4.4%). The mean duration of the follow-up was 395 days. Finally, 87 (82%) patients completely recovered, ten (9.4%) died, and nine (8.5%) reported sequelae. CONCLUSION: This systematic review summarized the state of the art on vertebral candidiasis, describing data on its clinical features, diagnostic criteria and current limitations, and treatment alternatives and their outcomes.

Long-Term Clinical and Radiographic Outcomes After Bryan Cervical Disk Arthroplasty: A Systematic Literature Review.

Introductionː Cervical disk arthroplasty is a potential alternative procedure to anterior cervical decompression and fusion for the treatment of cervical disk disease. The aim of the study was to perform a systematic literature review on long-term clinical and radiological outcomes after Bryan cervical disk arthroplasty.Material and Methodsː A systematic literature review was performed according to PRISMA guidelines via PubMed and Embase, Scopus, and the Cochrane Library database by using the following keywords: "Bryan prosthesis"; "cervical disk arthroplasty"; "outcomes"; and "long-term follow-up." Eight articles with at least 10 years of follow-up were considered for eligibility.Resultsː In total, 481 patients were enrolled in the studies. Because of the occurrence of multiple treated levels, 588 arthroplasties were performed, divided as follows: 12 C3/4 cervical disk arthroplasties (2.01%), 63 C4/5 (10.71%), 325 C5/6 (55.27%), and 188 C6/7 (31.97%). The mean preoperative cervical lordosis was 13.6 ± 9.3°, whereas the last follow-up value was 12.8 ± 8.7°. In the last follow-up, the mean segmental range of motion was 8.2 ± 3.3°.Discussion: Recent studies have suggested that cervical disk arthroplasty should be safely performed in healthy young patients with disk degeneration who may need future revision surgery. The results suggest that this procedure preserves native cervical spinal biomechanics at long-term follow-up with acceptable adjacent segments disease and periprosthetic ossifications.Conclusionsː Cervical disk arthroplasty has good long-term device survival, motility, adjacent segment degeneration, and clinical outcomes. Therefore, it represents a valid alternative for the treatment of cervical spine degenerative pathologies, especially in young patients.

Extreme Lateral Interbody Fusion (XLIF) with Lateral Modular Plate Fixation: Preliminary Report on Clinical and Radiological Outcomes.

The lateral transpsoas approach (extreme lateral interbody fusion, or XLIF) allows surgeons to use various lordotic cage sizes to help restore intervertebral disk height, correct sagittal alignment, and improve fusion rates. The use of standalone devices has consistently raised doubts due to the high risk of complications and inadequate functional recovery that a circumferential arthrodesis can support. The recent introduction of a novel XLIF cage with adapted lateral plate fixation (XLPF) may further enhance the structural rigidity, consolidating the cage and plate into a singular modular entity. Nine patients from our surgical centers underwent a procedure of 1-level XLIF with XLPF in selected cases. We observed that XLPF does not extend the intraoperative footprint and provides immediate rigidity to the anterior column without any additional risk of complications and with minimal increased time compared to the traditional cage implant procedure. Although it has been shown that the use of interbody fusion cages with supplemental posterior fixation improves stabilization in all directions, the technique of standalone lateral cages may also have a place in spine surgery in that the stability may be sufficient in selected cases, such as junctional syndrome and in some forms of degenerative scoliosis.

SPINE20 recommendations 2021: spine care for people's health and prosperity.

PURPOSE: The focus of SPINE20 is to develop evidence-based policy recommendations for the G20 countries to work with governments to reduce the burden of spine disease, and disability. METHODS: On September 17-18, 2021, SPINE20 held its annual meeting in Rome, Italy. Prior to the meeting, the SPINE20 created six proposed recommendations. These recommendations were uploaded to the SPINE20 website 10 days before the meeting and opened to the public for comments. The recommendations were discussed at the meeting allowing the participants to object and provide comments. RESULTS: In total, 27 societies endorsed the following recommendations. SPINE20 calls upon the G20 countries: (1) to expand telehealth for the access to spine care, especially in light of the current situation with COVID-19. (2) To adopt value-based interprofessional spine care as an approach to improve patient outcomes and reduce disability. (3) To facilitate access and invest in the development of a competent rehabilitation workforce to reduce the burden of disability related to spine disorders. (4) To adopt a strategy to promote daily physical activity and exercises among the elderly population to maintain an active and independent life with a healthy spine, particularly after COVID-19 pandemic. (5) To engage in capacity building with emerging countries and underserved communities for the benefit of spine patients. (6) To promote strategies to transfer evidence-based advances into patient benefit through effective implementation processes. CONCLUSIONS: SPINE20's initiatives will make governments and decision makers aware of efforts to reduce needless suffering from disabling spine pain through education that can be instituted across the globe.

Multidimensional assessment of cervical spondylotic myelopathy patients. Usefulness of a comprehensive score system.

OBJECTIVE: Cervical spondylotic myelopathy (CSM) is caused by cervical spine degeneration and surgery may be beneficial, but selection for surgery might be challenging. We performed a multimodal analysis to assess predicting factors that may be useful to help surgeons in this choice. PATIENTS AND METHODS: We retrospectively evaluated clinical, motor evoked potentials (MEP), and MRI data of patients who undergone surgery for CSM. Seventy-six consecutive patients (46 males) were enrolled. The median age was 65.5 [IQR: 57-71] years, and the duration of symptoms was 11 [8-13] months. A multivariate analysis in order to assess predictors of outcome and ROC curve analysis were performed. RESULTS: Thirty patients (M:18, 39.5%) gained 6 or more points on mJOA and they were collected in good recovery group, whereas 46 patients (60.5%, M:28) showed a fair recovery. We developed a comprehensive score system (CSS) taking into account clinical, neurophysiological, and neuroradiological data. ROC curve analysis was performed to determine the discriminative power of four models derived from the multivariate logistic regression analysis for predictors of good outcome considering only clinical variables, MRI variables, and MEP variables or considering the comprehensive model, demonstrating a good accuracy of CSS model to predict outcome. CONCLUSION: This study demonstrates that CSS model taking into consideration functional assessment by mJOA score, neurologic evaluation, cervical MRI, and MEP may be a feasible method to predict outcome in patients candidate to surgery, supporting surgeon's decisions both for those patients candidate to surgery and for patients in whom a "wait and see" approach could be proposed.

The role of femoral obliquity angle and T1 pelvic angle in predicting quality of life after spinal surgery in adult spinal deformities.

BACKGROUND: Adult spinal deformities (ASD) represent a growing clinical condition related to chronic pain, disability and reduction in quality of life (QoL). A strong correlation among spinal alignment, spinopelvic parameters and QoL after spinal fusion surgery in ASD patients was thoroughly investigated over the last decade, However, only few studies focused on the relationship between lumbo-pelvic-femoral parameters - such as Femoral Obliquity Angle (FOA), T1 Pelvic Angle (TPA) and QoL. METHODS: Radiological and clinical data from 43 patients surgically treated with thoracolumbar posterior spinal fusion for ASD between 2015 and 2018 were retrospectively analyzed. The primary outcomes were the correlation between preoperative spino-pelvic-femoral parameters and postoperative clinical, functional outcomes and QoL. Secondary outcomes were: changes in sagittal radiographic parameters spino-pelvic-femoral, clinical and functional outcomes and the rate of complications after surgery. RESULTS: Using Spearman's rank correlation coefficients, spinopelvic femoral parameters (FOA, TPA, pre and post-operative) are directly statistically correlated to the quality of life (ODI, SRS-22, pre and post-operative; > 0,6 strong correlation, p <  0.05). Stratifying the patients according pre preoperative FOA value (High FOA ≥ 10 and Normal/Low FOA <  10), those belonging to the first group showed worse clinical (VAS: 5.2 +/- 1.4 vs 2.9 +/- 0.8) and functional outcomes (ODI: 35.6+/- 6.8 vs 23.2 +/- 6.5) after 2 years of follow-up and a greater number of mechanical complications (57.9% vs 8.3% p <  0.0021). CONCLUSION: Based on our results, preoperative FOA and TPA could be important prognostic parameters for predicting disability and quality of life after spinal surgery in ASD patients and early indicators of possible spinal sagittal malalignment. FOA and TPA, like other and better known spinopelvic parameters, should always be considered when planning corrective surgery in ASD patients.

Radiological evaluation of fusion patterns after lateral lumbar interbody fusion: institutional case series.

INTRODUCTION: There is no consensus on how to evaluate segmental fusion after lateral lumbar interbody fusion (LLIF). Bone bridges (BB) between two contiguous vertebra are reported as pathognomonic criteria for anterior fusion. However, to the best of our knowledge, there are no radiological investigations on zygapophyseal joints (ZJ) status after LLIF. The aim of this radiological study was to investigate the different fusion patterns after LLIF. MATERIALS AND METHODS: This is a retrospective single-centre radiological study. Patients who underwent LLIF and posterior percutaneous screw fixation for degenerative spondylolisthesis, on a single lumbar level, were considered for eligibility. Complete radiological data and a minimum follow-up of 1 year were the inclusion criteria. Intervertebral BB were investigated for evaluating anterior fusion and ZJ ankylotic degeneration was evaluated according Pathria et al., as a matter of proof of posterior fusion and segmental immobilization. RESULTS: Seventy-four patients were finally included in the present study. Twelve months after surgery, intervertebral BB were recognized in 58 segments (78.3%), whereas ZJ Pathria grade was I in 8 (10.8%) patients, II in 15 (20.3%) and III in 51 (68.9%) that were considered posteriorly fused. The overlapping rate between anteriorly and posteriorly fused segments was 72.4% (42 segments), whereas 10 (13.5%) did not achieve any fusion, anterior or posterior, and 6 (8.1%) were posteriorly fused only. CONCLUSIONS: Our results seem to suggest that anterior fusion is not sufficient to achieve segmental immobilization. Further properly designed investigations are needed to investigate eventual clinical-radiological correlations.

Single-level Bryan cervical disc arthroplasty: evaluation of radiological and clinical outcomes after 18 years of follow-up.

PURPOSE: Many studies reported mid-term clinical and radiological outcomes after cervical disc arthroplasty. Only a few studies analysed the long-term results. The aim of the study was to evaluate the clinical and radiological outcomes in patients treated with single-level Bryan cervical disc arthroplasty after 18 years of follow-up. METHODS: This study was a retrospective analysis of institutional databases concerning patients treated with Bryan cervical disc arthroplasty. SF36 PCS, NDI and VAS were used to evaluate clinical and functional outcomes. Standard, flexion-extension X-ray and MRI were used to evaluate the radiological results. RESULTS: Fifty-seven patients treated with single-level Bryan cervical disc arthroplasty completed the 18-year follow-up. At the final follow-up, a residual movement was observed in 32 patients (56%). The treated level range of motion decreased from 10.1° pre-operatively to 6.1° at the last follow-up (p = 0.0021). The range of motion of the adjacent segments and of the cervical spine had no significant change. Disc degeneration of the adjacent segment after 18-year follow-up was observed in 77.1% of treated patients. CONCLUSION: The clinical and radiographic outcomes 18 years after surgery are acceptable. The treated level range of motion reduction and the adjacent segment degeneration seems not to affect the clinical results after 18 years of follow-up.

Extensive Spinal Epidural Abscesses Resolved with Minimally Invasive Surgery: Two Case Reports and Review of the Recent Literature.

PURPOSE: An extensive spinal epidural abscess is a rare condition and causes significant morbidity and mortality. Few authors have described this uncommon entity, which requires early diagnosis and optimal treatment to avoid devastating complications. The purpose of this study was to evaluate a minimally invasive technique for treatment of an extensive spinal epidural abscess by describing two cases. Furthermore, we conducted a review of the recent literature on the management of this rare condition. METHODS: We report two cases of spinal abscesses extending to the whole epidural space, successfully treated by use of a minimally invasive technique consisting of multilevel laminotomy and catheter irrigation to decompress and drain the epidural space. RESULTS: This technique is able to decompress the spinal cord, isolate the pathogen and evacuate the abscess. No complications, late spine deformity or dura penetration were observed in our patients. CONCLUSION: Urgent surgical decompression, in combination with long-term antibiotic treatment, is generally considered the treatment of choice for an extensive spinal epidural abscess. A minimally invasive technique can be very useful as a surgical option.

Minimally invasive surgery procedure in isthmic spondylolisthesis.

PURPOSE: The aim of the study was to evaluate the efficacy and safety of the direct lateral approach to the lumbar spine in the treatment of painful isthmic spondylolisthesis in adults. METHODS: Twenty-one patients affected by isthmic spondylolisthesis and treated with extreme lateral interbody fusion and posterior percutaneous pedicle screw fixation were enrolled. All included patients were clinically evaluated with Oswestry Disability Index, SF36 and Visual Scale Anatomy (VAS) for back pain at 1, 3 months and at 1 year. RESULTS: The mean correction of vertebral slippage measured on lateral lumbar X-ray was 56.3% (p = 0.002). The average preoperative VAS score was 7.1, at 1 year decreasing to 2.2 (p = 0.001). The patients had an average preoperative "Oswestry Disability Index" of 36.8 and 24.1% after 1 year (p = 0.02). The preoperative Short-Form 36 Physical Health was equal to 33.8, 72.1% after 1 month, to 76.3% after 3 months and to 83.2% (p = 0.001) after 1 year of follow-up. There were no signs of implant loosening at 1-year CT scan examination in any of the patients. CONCLUSION: The study showed that the extreme lateral approach to the lumbar spine in case of isthmic spondylolisthesis is a reliable and safe option to the most common open procedures. In the authors' opinion, XLIF procedures allow a good correction of the listhesis associated with good clinical and radiographic results. These slides can be retrieved under Electronic supplementary material.

Intraspinal extradural benign fibrous histiocytoma of the lumbar spine in a pediatric patient. Case report and literature review.

INTRODUCTION: Benign fibrous histiocytoma (BFH) is a rare skeletal tumor. Spinal localizations have been previously described in 17 cases, and this is the first report of BFH occurring at the lumbar spine in a pediatric patient. CASE REPORT: A 13-year-old male complained lower limb motor and sensory impairment with severe claudication and urination disorders. A huge intraspinal, extradural mass at L4-L5 level, clearly evident on a preoperative MRI, caused dislocation and severe compression of the cauda equina nerve roots. After a biopsy, confirming BFH, a tumor resection and L4-S1 vertebral arthrodesis was carried out. At 1 year follow-up, no recurrence was detached on postoperative MRI, with complete neurological recovery. DISCUSSION AND CONCLUSION: Review of the literature is discussed. Histological examination is mandatory for a correct diagnosis and plan of treatment. None of the pediatric patients treated for BFH have ever shown local relapse.

Thoracic synovial cyst as cause of cord compression in a patient with Charcot-Marie-Tooth disease.

An 80-year-old male patient affected by Charcot-Marie-Tooth (CMT) disease came to our attention in July 2020, for the occurrence of low back pain and lower limb weakness, and also saddle anesthesia, urinary and faecal retention were referred. His diagnosis of CMT is dated back to 1955 and through the years, the clinical picture slowly worsened but never got particularly severe. The quick symptoms outbreak and the presence of urinary disturbances were red flags, which lead us to direct the diagnostic orientation elsewhere. A Magnetic Resonance Imaging of the thoraco-lumbar spinal cord was then performed and it was suggestive for synovial cyst at T10-T11. The patient underwent a decompression with laminectomy and then stabilized through arthrodesis. In the very next days after the surgery, the patient showed a sudden and significant improvement of his condition. At the last visit, he showed a remarkable relief of the symptoms, walking by himself.

Posterior Percutaneous Pedicle Screws Fixation Versus Open Surgical Instrumented Fusion for Thoraco-Lumbar Spinal Metastases Palliative Management: A Systematic Review and Meta-analysis.

Background: Surgical palliative treatment of spinal metastases (SM) could influence the quality of life (QoL) in cancer patients, since the spine represents the most common site of secondary bony localization. Traditional open posterior instrumented fusion (OPIF) and Percutaneous pedicle screw fixation (PPSF) became the main surgical treatment alternatives for SM, but in Literature there is no evidence that describes the absolute superiority of one treatment over the other. Materials and Methods: This is a systematic review and meta-analysis of comparative studies on PPSF versus OPIF in patients with SM, conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. The outcomes of interest were: complications, blood loss, infections, mortality, pain and also the Quality of Life (QoL). Results: There were a total of 8 studies with 448 patients included in the meta-analyses. Postoperative complications were more frequent in OPIF (odds ratio of 0.48. 95% CI, 0.27 to 0.83; p= 0.01), PPFS was associated with blood loss (odds ratio -585.70. 95% IC, -848.28 to -323.13.69; p< 0.0001) and a mean hospital stay (odds ratio -3.77. 95% IC, -5.92 to -1.61; p= 0.0006) decrease. The rate of infections was minor in PPFS (odds ratio of 0.31. 95% CI, 0.12 to 0.81; p= 0.02) whereas the occurrence of reinterventions (0.76. 95% CI, 0.25 to 2.27; p= 0.62) and the mortality rate was similar in both groups (odds ratio of 0.79. 95% CI, 0.40 to 1.58; p= 0.51). Finally, we also evaluated pre and post-operative VAS and the meta-analysis suggested that both techniques have a similar effect on pain. Discussion and Conclusion: The PPSF treatment is related with less complications, a lower rate of infections, a reduction in intraoperative blood loss and a shorter hospital stay compared to the OPIF treatment. However, further randomized clinical trials could confirm the results of this meta-analysis and provide a superior quality of scientific evidence.

Single-Level Anterior Cervical Discectomy and Interbody Fusion: A Comparison between Porous Tantalum and Polyetheretherketone Cages.

Background: Anterior cervical discectomy and interbody fusion (ACDF) may be performed with different kinds of stand-alone cages. Tantalum and polyetheretherketone (PEEK) are two of the most commonly used materials in this procedure. Few comparisons between different stand-alone implants for ACDF have been reported in the literature. Methods: We performed a comparison between patients who underwent ACDF with either a porous tantalum or a PEEK stand-alone cage, in two spine surgery units for single-level disc herniation. Clinical outcome [Neck Disability Index (NDI), Visual Analog Scale (VAS) for pain, Short Form-36 (SF-36)] and radiological outcome (lordosis, fusion and subsidence) were measured before surgery and at least one year after surgery in both groups. Results: Thirty-eight patients underwent ACDF with a porous tantalum cage, and thirty-one with a PEEK cage. The improvement of NDI and SF-36 was significantly superior in the PEEK group (p = 0.002 and p = 0.049 respectively). Moreover, the variation of the Cobb angle for the cervical spine was significantly higher in the PEEK group (p < 0.001). Conclusions: In a retrospective analysis of two groups of patients with at least one year of follow-up, a stand-alone PEEK cage showed superior clinical results, with improved cervical lordosis, compared to a stand-alone porous tantalum cage. Further studies are needed to confirm these data.

Increased Frequency of Hand Hygiene and Other Infection Prevention Practices Correlates with Reduced Surgical Wound Infection Rates in Spinal Surgery during the COVID-19 Pandemic.

BACKGROUND: Due to the COVID-19 pandemic outbreak, many changes were done in the hospital practice, and new guidelines were issued in order to contain the infection spread. One of the most common measures is represented by a correct and frequent hand washing. Recently, an association between increased adherence to hand hygiene (HH) protocols and reduction in hospital infections was documented however no studies about the surgical wound infection rate were reported in the Literature. METHODS: The present study represents a multicentric retrospective epidemiological study. The HH compliance rate was recorded through direct observations by trained nurses, 24 h a day. The primary outcome was HH compliance rate. The association of HH with spinal surgical wound infections was the secondary outcome. RESULTS: We reported a compliance to HH practices during the pandemic period of 85.2% compared with 57% observed during 2019. Our analysis showed an overall surgical wound infection reduction of 66.6% during the hospital stay in the pandemic period. CONCLUSION: Hand hygiene has always been considered one of the most effective, reproducible and low-cost weapons to deal with hospital infections. The good health habits acquired during the COVID-19 pandemic should be maintained even after the virus is eradicated.

Critical analysis of lumbar interspinous devices failures: a retrospective study.

Interspinous devices (IDs) were introduced in the 90s. Since then, they have rapidly become very popular for the minimally invasive treatment of lumbar pain disorders. They feature different shapes and biomechanical characteristics, and are used in the spine degenerative pathologies or as motion segment stabilizers (dynamic stabilization) or to obtain the decompression of neurological structures. The indications seem to be rather narrow and still to be verified in terms of their clinical efficacy. However, IDs are being extensively utilized beyond their classical indications with the inevitable risk of a clinical failure. The aim of the present work was to carry out a critical analysis of the causes of failure in a series of 19 patients. From January 2007 to March 2009, 19 patients with residual painful syndrome after the implantation of IDs were observed. The series includes 11 males and 8 females with a mean age of 53.6 years (range 38-84 years) who were operated on elsewhere and who underwent revision surgery at our hospital. The inclusion criteria were low back pain and/or radiculopathy after the device implantation without improvement of the painful symptomatology, radiculopathy with signs of sensory and motor deficit, intermittent neurogenic claudication, and infection. All patients were thoroughly re-assessed with new standard imaging examinations such as MRI and CT scans, considering the following image features: the position of the device with respect to the spinous processes (X-ray), the intervertebral disc disease of the level operated upon or of the adjacent levels (MRI), the segmental instability (dynamic X-rays), the severity of the canal stenosis (CT). The accurate evaluation of the clinical and imaging parameters revealed three main causes of failure: errors of indication, technical errors and the structural failure of the ID. The most frequent cause of failure was a wrong indication. The results of the study are presented and the causes of failure are discussed in detail.

Cauda equina syndrome and spine manipulation: case report and review of the literature.

Cauda equina syndrome seems to be a very rare complication of spinal manipulations. Only few cases, in fact, were referred in literature in the past decades. Most of them are very old and poorly documented evoking doubts about the pathogenetic relationship between the spinal maneuvers and the onset of the syndrome. We observed and treated a 42-year-old patient who complained a rapid onset of saddle hypoparesthesia and urine retention only a few hours after the spinal manipulation performed for L5-S1 herniated disc. The comparison of the two following MRIs performed before and after the manipulations seems to prove a close pathogenetic relationship. The patient was operated soon after the admission to our emergency department and 1 year later he referred an incomplete recovery of the syndrome. The case offered the opportunity to update the literature. The review revealed only three cases from the beginning of the current century that confirm the rarity of the syndrome. Based on the data emerging from the official literature, safety of the manipulations and its pathogenetic aspects in causing lumbar radiculopathies are discussed.

Correction of a severe coronal malalignment in adult spinal deformity using the "kickstand rod" technique as primary surgery.

OBJECTIVE: Adult spinal deformity (ASD) is a growing healthcare issue due to the aging population. A satisfying spine balance in both sagittal and coronal planes is achieved through surgery. Only few studies about the coronal alignment correction with the kickstand rod were reported in the literature, until now. The aim of the present study was to describe clinical and radiological outcomes of the Kickstand rod (KR) technique in a series of ASD patients with severe coronal malalignment after 1 year of follow-up. MATERIAL AND METHODS: Six patients affected by ASD with severe CM who underwent surgery between 2018 and 2019 were retrospectively analyzed. The mean follow up was 14 months. All patients had posterior-only approach with long pelvic-thoracic fixation according to the Kickstand rod technique. RESULTS: Postoperative alignment and pain numerical rating scale scores significantly improved. No instrumentation complications occurred. A coronal alignment improvement from a mean of 163 mm preoperatively to a mean of 32 mm postoperatively was observed. CONCLUSION: KR technique appears to be a safe and efficient way for coronal and sagittal imbalance correction in ASD patients. Although technically demanding, by using this technique good and stable radiological and functional outcomes are achieved especially in selected patients.