STUDY DESIGN.Systematic review of randomized and nonrandomized comparative studies.
OBJECTIVE.To summarize the literature examining comparative effectiveness and economic evaluation of minimally ...invasive versus open transforaminal/posterior lumbar interbody fusion (T/PLIF).
SUMMARY OF BACKGROUND DATA.Minimally invasive approaches to lumbar fusion have been proposed as an alternative to open surgery to decrease patient morbidity and improve clinical and patient-reported outcomes, with the possibility of secondary cost-savings. The comparative clinical and economic effectiveness of minimally invasive versus open T/PLIF remains largely undetermined.
METHODS.A systematic review of Medline, EMBASE, Web of Science, and Cochrane from database inception to September 2015 inclusive was performed. Reference lists were manually searched. Studies comparing MIS to open T/PLIF for degenerative lumbar conditions, including at least 10 patients in each arm and reporting at least one clinical, perioperative, radiographic, adverse event, or economic outcome, were included.
RESULTS.Between database inception and October 2015, 45 studies meeting inclusion criteria were identified with 3472 subjects undergoing MIS fusion and 5925 having an open procedure. There were no significant differences in operative time between the two groups, whereas patients undergoing MIS fusion consistently demonstrated less blood loss (16.1–88.7%) and shorter hospital stays (15.0–64.0% shorter). There was no difference in variably reported VAS, ODI, SF-36, SF-12, or EQ-5D scores between the two techniques at intermediate to long-term follow-up (12–60 months). Complication rates and fusion rates were also equivalent between the two groups. Economic studies demonstrate cost-savings in favor of MIS fusion ranging from 2.5 to 49.3%.
CONCLUSION.Limited quality comparative observational cohort and randomized controlled studies of MIS versus open T/PLIF consistently demonstrate improved perioperative outcomes including operative time, estimated blood loss, and length of stay with no significant difference in patient-reported outcomes or complication rates between the two groups at final follow-up. Increasing economic data suggest both direct and indirect cost-savings in favor of MIS fusion.Level of EvidenceN/A
STUDY DESIGN.A retrospective cohort study at a single institution.
OBJECTIVE.The aim of this study was to analyze the perioperative and postoperative outcomes of patients who underwent open ...transforaminal lumbar interbody fusion (O-TLIF) and bilateral minimally invasive surgery (MIS) Wiltse approach TLIF (Wil-TLIF).
SUMMARY OF BACKGROUND DATA.Several studies have compared open TLIF to MIS TLIF; however, comparing the techniques using a large cohort of one-level TLIFs has not been fully explored.
METHODS.We reviewed the charts of patients undergoing a single-level primary posterior lumbar interbody fusion between 2012 and 2017. The cases were categorized as Open TLIF (traditional midline exposure including lateral exposure of transverse processes) or bilateral paramedian Wiltse TLIF approach. Differences between groups were assessed by t tests.
RESULTS.Two hundred twenty-seven patients underwent one-level primary TLIF (116 O-TLIF, 111 Wil-TLIF). There was no difference in age, gender, American Society of Anesthesiologists (ASA), or body mass index (BMI) between groups. Wil-TLIF had the lowest estimated blood loss (EBL; 197 vs. 499 mL O-TLIF, P ≤ 0.001), length of stay (LOS; 2.7 vs. 3.6 days O-TLIF, P ≤ 0.001), overall complication rate (12% vs. 24% O-TLIF, P = 0.015), minor complication rate (7% vs. 16% O-TLIF, P = 0.049), and 90-day readmission rate (1% vs. 8% O-TLIF, P = 0.012). Wil-TLIF was associated with the higher fluoroscopy time (83 vs. 24 seconds O-TLIF, P ≤ 0.001). There was not a significant difference in operative time, intraoperative or neurological complications, extubation time, reoperation rate, or infection rate.
CONCLUSION.In comparing Wiltse MIS TLIF to Open TLIF, the minimally invasive paramedian Wiltse approach demonstrated the lowest EBL, LOS, readmission rates, and complications, but longer fluoroscopy times when compared with the traditional open approach.Level of Evidence3
STUDY DESIGN.A prospective randomized clinical trial.
OBJECTIVE.In this study, we determine whether percutaneous vertebroplasty (PVP) offers extra benefits to aged patients with acute osteoporotic ...vertebral compression fractures (OVCFs) over conservative therapy (CV).
SUMMARY OF BACKGROUND DATA.OVCFs are common in the aged population with osteoporosis. While the optimal treatment of aged patients with acute OVCFs remains controversial, PVP, a minimally invasive procedure, is a treatment option to be considered.
METHODS.Patients aged at 70 years or above with acute OVCF and severe pain from minor or mild trauma were assigned randomly to PVP and CV groups. The primary outcome was pain relief as measured by VAS score in 1-year follow-up period. The second outcome was quality of life assessed with ODI and Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO). Patient satisfaction surveys were also recorded.
RESULTS.A total of 135 patients were enrolled, and 107 (56 in PVP group; 51 in CV group) completed 1-year follow-up. In PVP group, the vertebroplasty procedure was performed at a mean of 8.4 ± 4.6 days (range, 2–21 days) after onset. Vertebroplasty resulted in much greater pain relief than did conservative treatment at postoperative day 1 (P < 0.0001). At every time point of follow-up, pain relief and quality of life were significantly improved in PVP group than in CV group at 1 week, 1 month, 3 months, 6 months, and 1 year (all P < 0.0001). The final follow-up surveys indicated that patients in PVP group were significantly more satisfied with given treatment (P < 0.0001). In addition, lower rate of complications was observed in PVP group (P < 0.0001).
CONCLUSION.In aged patients with acute OVCF and severe pain, early vertebroplasty yielded faster, better pain relief and improved functional outcomes, which were maintained for 1 year. Furthermore, it showed fewer complications than conservative treatment.Level of Evidence2
STUDY DESIGN.A retrospective cohort study.
OBJECTIVE.To determine the risk factors of cage subsidence in patients undergoing minimally invasive transforaminal lumbar interbody fusion (MI-TLIF) and ...its correlation with patient-reported outcomes.
SUMMARY OF BACKGROUND DATA.Cage subsidence is among the cage-related complications after TLIF and may lead to poor outcomes. Few studies have addressed the incidence of cage subsidence in MI-TLIF.
METHODS.This retrospective study of a prospectively collected database was conducted from October 2015 to October 2017. All patients received MI-TLIF with a minimum of 2-year follow-up. All levels were separated into the cage subsidence (CS group) and no cage subsidence (non-CS group) groups. Cage subsidence was evaluated using lateral radiographs and defined as more than 2 mm migration of the cage into the endplate of adjacent vertebral body. Patient demographics, perioperative details, and radiographic parameters were recorded. Cage-related parameters were cage height, cage insertion level, and cage position. Cage position was recorded using central point ration (CPR). Patient-reported outcome was analyzed using the Oswestry Disability Index (ODI) questionnaire and Visual Analog Scale (VAS) preoperatively and at 2 years postoperatively.
RESULTS.Ninety-three patients (126 levels) were included. Mean age was 66.5 years with an average follow-up of 36.9 months. Overall incidence of cage subsidence was 34.1%. The CS group had significantly higher body mass index, less bone mineral density (BMD), shorter disc height, and higher CPR than the non-CS group. BMD, disc height, and CPR were significantly negatively correlated with depth of cage subsidence. ODI improvement was significantly lesser in the CS group than in the non-CS group. Fusion rate and complications were unrelated to cage subsidence.
CONCLUSION.The BMD, disc height, and cage position were the most significant risk factors that were negatively correlated with depth of cage subsidence. Placing a TLIF cage anteriorly if possible may reduce the risk of cage subsidence.Level of Evidence3
The aim of this study was to compare the incidence of intra-operative and post-operative complications in open and minimally invasive radical hysterectomy for patients with early-stage cervical ...cancer.
Data were collected from the SUCCOR database of 1272 patients with stage IB1 cervical cancer (International Federation of Gynecology and Obstetrics (FIGO), 2009) who underwent radical hysterectomy in Europe between January 2013 and December 2014. We reviewed the duration of the surgeries, estimated blood loss, length of hospital stay, intra-operative and post-operative complications. The inclusion criteria were age ≥18 years and histologic type (squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma). Pelvic MRI confirming a tumor diameter ≤4 cm with no parametrial invasion and a pre-operative CT scan, MRI, or positron emission tomography CT demonstrating no extra-cervical metastatic disease were mandatory. Outcomes of interest were any grade >3 adverse events, intra-operative adverse events, post-operative adverse events, length of hospital stay, length of operation, and blood loss.
The study included 1156 patients, 633 (54%) in the open surgery group and 523 (46%) in the minimally invasive surgery group. Median age was 46 years (range 18-82), median body mass index 25 kg/m
(range 15-68), and 1022 (88.3%) patients were considered to have an optimal performance status (ECOG Performance Status 0). The most common histologic tumor type was squamous carcinoma (n=794, 68.7%) and the most frequent FIGO staging was IB1 (n=510, 44.1%). In the minimally invasive surgery group the median duration of surgery was longer (240 vs 187 min, p<0.01), median estimated blood loss was lower (100 vs 300 mL, p<0.01), and median length of hospital stay was shorter (4 vs 7 days, p<0.01) compared with the abdominal surgery group. There was no difference in the overall incidence of intra-operative and post-operative complications between the two groups. Regarding grade I complications, the incidence of vaginal bleeding (2.9% vs 0.6%, p<0.01) and vaginal cuff dehiscence was higher in the minimally invasive surgery group than in the open group (3.3% vs 0.5%, p<0.01). Regarding grade III post-operative complications, bladder dysfunction (1.3% vs 0.2%, p=0.046) and abdominal wall infection (1.1% vs 0%, p=0.018) were more common in the open surgery group than in the minimally invasive surgery group. Ureteral fistula was more frequent in the minimally invasive group than in the open surgery group (1.7% vs 0.5%, p=0.037).
Our study showed that there was no significant difference in the overall incidence of intra-operative and post-operative complications between minimally invasive radical hysterectomy and the open approach.
STUDY DESIGN.A retrospective cohort study of prospectively collected data.
OBJECTIVE.The aim of this study was to describe the development of and early experience with an evidence-based enhanced ...recovery after surgery (ERAS) pathway for lumbar decompression.
SUMMARY OF BACKGROUND DATA.ERAS protocols have been consistently associated with improved patient experience and outcomes, and reduced cost and length of hospital stay (LoS). Despite successes in other orthopedic subspecialties, ERAS has yet to be established in spine surgery. Here, we report the development of and initial experience with the first comprehensive ERAS pathway for MIS lumbar spine surgery.
METHODS.An evidence-based review of the literature was performed to select components of the ERAS pathway. The pathway was applied to 61 consecutive patients presenting for microdiscectomy or lumbar laminotomy/laminectomy between dates. Data collection was performed by review of the electronic medical record. We evaluated compliance with individual ERAS process measures, and adherence to the overall pathway. The primary outcome was LoS. Demographics, comorbidities, perioperative course, prevalence of opioid tolerance, and factors affecting LoS were also documented.
RESULTS.The protocol included 15 standard ERAS elements. Overall pathway compliance was 85.03%. Median LoS was 279 minutes interquartile range (IQR) 195–398 minutes overall, 298 minutes (IQR 192–811) for lumbar decompression and 285 minutes (IQR 200–372) for microdiscectomy. There was no correlation between surgical subtype or duration and LoS. Overall, 37% of the cohort was opioid-tolerant at the time of surgery. There was no significant effect of baseline opioid use on LoS, or on the total amount of intraoperative or PACU opioid administration. There were four complications (6.5%) resulting in extended LoS (>23 hours).
CONCLUSION.This report comprises the first description of a comprehensive, evidence-based ERAS for spine pathway, tailored for lumbar decompression/microdiscectomy resulting in short LoS, minimal complications, and no readmissions within 90 days of surgery.Level of Evidence3
Acute stroke due to supratentorial intracerebral haemorrhage is associated with high morbidity and mortality. Open craniotomy haematoma evacuation has not been found to have any benefit in large ...randomised trials. We assessed whether minimally invasive catheter evacuation followed by thrombolysis (MISTIE), with the aim of decreasing clot size to 15 mL or less, would improve functional outcome in patients with intracerebral haemorrhage.
MISTIE III was an open-label, blinded endpoint, phase 3 trial done at 78 hospitals in the USA, Canada, Europe, Australia, and Asia. We enrolled patients aged 18 years or older with spontaneous, non-traumatic, supratentorial intracerebral haemorrhage of 30 mL or more. We used a computer-generated number sequence with a block size of four or six to centrally randomise patients to image-guided MISTIE treatment (1·0 mg alteplase every 8 h for up to nine doses) or standard medical care. Primary outcome was good functional outcome, defined as the proportion of patients who achieved a modified Rankin Scale (mRS) score of 0–3 at 365 days, adjusted for group differences in prespecified baseline covariates (stability intracerebral haemorrhage size, age, Glasgow Coma Scale, stability intraventricular haemorrhage size, and clot location). Analysis of the primary efficacy outcome was done in the modified intention-to-treat (mITT) population, which included all eligible, randomly assigned patients who were exposed to treatment. All randomly assigned patients were included in the safety analysis. This study is registered with ClinicalTrials.gov, number NCT01827046.
Between Dec 30, 2013, and Aug 15, 2017, 506 patients were randomly allocated: 255 (50%) to the MISTIE group and 251 (50%) to standard medical care. 499 patients (n=250 in the MISTIE group; n=249 in the standard medical care group) received treatment and were included in the mITT analysis set. The mITT primary adjusted efficacy analysis estimated that 45% of patients in the MISTIE group and 41% patients in the standard medical care group had achieved an mRS score of 0–3 at 365 days (adjusted risk difference 4% 95% CI −4 to 12; p=0·33). Sensitivity analyses of 365-day mRS using generalised ordered logistic regression models adjusted for baseline variables showed that the estimated odds ratios comparing MISTIE with standard medical care for mRS scores higher than 5 versus 5 or less, higher than 4 versus 4 or less, higher than 3 versus 3 or less, and higher than 2 versus 2 or less were 0·60 (p=0·03), 0·84 (p=0·42), 0·87 (p=0·49), and 0·82 (p=0·44), respectively. At 7 days, two (1%) of 255 patients in the MISTIE group and ten (4%) of 251 patients in the standard medical care group had died (p=0·02) and at 30 days, 24 (9%) patients in the MISTIE group and 37 (15%) patients in the standard medical care group had died (p=0·07). The number of patients with symptomatic bleeding and brain bacterial infections was similar between the MISTIE and standard medical care groups (six 2% of 255 patients vs three 1% of 251 patients; p=0·33 for symptomatic bleeding; two 1% of 255 patients vs 0 0% of 251 patients; p=0·16 for brain bacterial infections). At 30 days, 76 (30%) of 255 patients in the MISTIE group and 84 (33%) of 251 patients in the standard medical care group had one or more serious adverse event, and the difference in number of serious adverse events between the groups was statistically significant (p=0·012).
For moderate to large intracerebral haemorrhage, MISTIE did not improve the proportion of patients who achieved a good response 365 days after intracerebral haemorrhage. The procedure was safely adopted by our sample of surgeons.
National Institute of Neurological Disorders and Stroke and Genentech.
The steerable catheter refers to the catheter that is manipulated by a mechanism which may be driven by operators or by actuators. The steerable catheter for minimally invasive surgery has rapidly ...become a rich and diverse area of research. Many important achievements in design, application and analysis of the steerable catheter have been made in the past decade. This paper aims to provide an overview of the state of arts of steerable catheters. Steerable catheters are classified into four main groups based on the actuation principle: (1) tendon driven catheters, (2) magnetic navigation catheters, (3) soft material driven catheters (shape memory effect catheters, steerable needles, concentric tubes, conducting polymer driven catheters and hydraulic pressure driven catheters), and (4) hybrid actuation catheters. The advantages and limitations of each of them are commented and discussed in this paper. The future directions of research are summarized.
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