Why Are Outcomes Different for Registry Patients Enrolled Prospectively and Retrospectively? Insights from the Global Anticoagulant Registry in the FIELD-Atrial Fibrillation (GARFIELD-AF).

Background: Retrospective and prospective observational studies are designed to reflect real-world evidence on clinical practice, but can yield conflicting results. The GARFIELD-AF Registry includes both methods of enrolment and allows analysis of differences in patient characteristics and outcomes that may result. Methods and Results: Patients with atrial fibrillation (AF) and ≥1 risk factor for stroke at diagnosis of AF were recruited either retrospectively (n = 5069) or prospectively (n = 5501) from 19 countries and then followed prospectively. The retrospectively enrolled cohort comprised patients with established AF (for a least 6, and up to 24 months before enrolment), who were identified retrospectively (and baseline and partial follow-up data were collected from the emedical records) and then followed prospectively between 0-18 months (such that the total time of follow-up was 24 months; data collection Dec-2009 and Oct-2010). In the prospectively enrolled cohort, patients with newly diagnosed AF (≤6 weeks after diagnosis) were recruited between Mar-2010 and Oct-2011 and were followed for 24 months after enrolment. Differences between the cohorts were observed in clinical characteristics, including type of AF, stroke prevention strategies, and event rates. More patients in the retrospectively identified cohort received vitamin K antagonists (62.1% vs. 53.2%) and fewer received non-vitamin K oral anticoagulants (1.8% vs . 4.2%). All-cause mortality rates per 100 person-years during the prospective follow-up (starting the first study visit up to 1 year) were significantly lower in the retrospective than prospectively identified cohort (3.04 [95% CI 2.51 to 3.67] vs . 4.05 [95% CI 3.53 to 4.63]; p = 0.016). Conclusions: Interpretations of data from registries that aim to evaluate the characteristics and outcomes of patients with AF must take account of differences in registry design and the impact of recall bias and survivorship bias that is incurred with retrospective enrolment. Clinical Trial Registration: - URL: http://www.clinicaltrials.gov . Unique identifier for GARFIELD-AF (NCT01090362)

Risk profiles and one-year outcomes of patients with newly diagnosed atrial fibrillation in India: Insights from the GARFIELD-AF Registry.

BACKGROUND: The Global Anticoagulant Registry in the FIELD-Atrial Fibrillation (GARFIELD-AF) is an ongoing prospective noninterventional registry, which is providing important information on the baseline characteristics, treatment patterns, and 1-year outcomes in patients with newly diagnosed non-valvular atrial fibrillation (NVAF). This report describes data from Indian patients recruited in this registry. METHODS AND RESULTS: A total of 52,014 patients with newly diagnosed AF were enrolled globally; of these, 1388 patients were recruited from 26 sites within India (2012-2016). In India, the mean age was 65.8 years at diagnosis of NVAF. Hypertension was the most prevalent risk factor for AF, present in 68.5% of patients from India and in 76.3% of patients globally (P < 0.001). Diabetes and coronary artery disease (CAD) were prevalent in 36.2% and 28.1% of patients as compared with global prevalence of 22.2% and 21.6%, respectively (P < 0.001 for both). Antiplatelet therapy was the most common antithrombotic treatment in India. With increasing stroke risk, however, patients were more likely to receive oral anticoagulant therapy [mainly vitamin K antagonist (VKA)], but average international normalized ratio (INR) was lower among Indian patients [median INR value 1.6 (interquartile range {IQR}: 1.3-2.3) versus 2.3 (IQR 1.8-2.8) (P < 0.001)]. Compared with other countries, patients from India had markedly higher rates of all-cause mortality [7.68 per 100 person-years (95% confidence interval 6.32-9.35) vs 4.34 (4.16-4.53), P < 0.0001], while rates of stroke/systemic embolism and major bleeding were lower after 1 year of follow-up. CONCLUSION: Compared to previously published registries from India, the GARFIELD-AF registry describes clinical profiles and outcomes in Indian patients with AF of a different etiology. The registry data show that compared to the rest of the world, Indian AF patients are younger in age and have more diabetes and CAD. Patients with a higher stroke risk are more likely to receive anticoagulation therapy with VKA but are underdosed compared with the global average in the GARFIELD-AF. CLINICAL TRIAL REGISTRATION-URL: http://www.clinicaltrials.gov. Unique identifier: NCT01090362

The effect of implant placement on sacroiliac joint range of motion: Posterior versus transarticular

© 2015, Wolters Kluwer Health, Inc. Study Design. A human cadaveric biomechanical study of 2 sacroiliac (SI) joint fusion implant placement techniques. Objective. To evaluate and compare the biomechanical properties of 2 implant placement techniques for SI joint fusion. Summary of Background Data. Minimally invasive placement of SI joint fusion implants is a potential treatment of SI joint disruptions and degenerative sacroiliitis. Biomechanical studies of screw fixation within the sacrum have shown that placement and trajectory are important in the overall stability of the implant. Although clinical results have been promising, there is the possibility that a more optimal arrangement of implants may exist. Methods. Bilateral SI joints in 7 cadaveric lumbopelvic (L4-pelvis) specimens were tested using a single leg stance model. All joints were tested intact, pubic symphysis sectioned, and treated (3 SI joint fusion implants). The implants were laterally placed using either a posterior or transarticular placement technique. The posterior technique places the implants inline in the inlet view, parallel in the outlet view, and parallel to the posterior sacral body in the lateral view. The transarticular technique places all implants across the articular portion of the SI joint. For all conditions, the range of motion was tested in flexion-extension, lateral bending, and axial rotation. Results. The posterior technique significantly reduced the range of motion in flexion-extension, lateral bending, and axial rotation by 27% ± 24% (P = 0.024), 28% ± 26% (P = 0.028), and 32% ± 21% (P = 0.008), respectively. The transarticular technique significantly reduced the range of motion in flexion-extension, lateral bending, and axial rotation by 41% ± 31% (P = 0.013), 36% ± 38% (P = 0.049), and 36% ± 28% (P = 0.015), respectively. No significant differences were detected between the posterior and transarticular placement techniques (P \u3e 0.25). Conclusion. Posterior and transarticular placement of SI joint fusion implants stabilized the SI joint in flexion-extension, lateral bending, and axial rotation

Biomechanical Analysis Of An Expandable Lumbar Interbody Spacer

Objective: Recently developed expandable interbody spacers are widely accepted in spinal surgery; however, the resulting biomechanical effects of their use have not yet been fully studied. We analyzed the biomechanical effects of an expandable polyetheretherketone interbody spacer inserted through a bilateral posterior approach with and without different modalities of posterior augmentation. Methods: Biomechanical nondestructive flexibility testing was performed in 7 human cadaveric lumbar (L2–L5) specimens followed by axial compressive loading. Each specimen was tested under 6 conditions: 1) intact, 2) bilateral L3–L4 cortical screw/rod (CSR) alone, 3) WaveD alone, 4) WaveD + CSR, 5) WaveD + bilateral L3–L4 pedicle screw/rod (PSR), and 6) WaveD + CSR/PSR, where CSR/PSR was a hybrid construct comprising bilateral cortical-level L3 and pedicle-level L4 screws interconnected by rods. Results: The range of motion (ROM) with the interbody spacer alone decreased significantly compared with the intact condition during flexion–extension (P = 0.02) but not during lateral bending or axial rotation (P ≥ 0.19). The addition of CSR or PSR to the interbody spacer alone condition significantly decreased the ROM compared with the interbody spacer alone (P ≤ 0.002); and WaveD + CSR, WaveD + PSR, and WaveD + CSR/PSR (hybrid) (P ≥ 0.29) did not differ. The axial compressive stiffness (resistance to change in foraminal height during compressive loading) with the interbody spacer alone did not differ from the intact condition (P = 0.96), whereas WaveD + posterior instrumentation significantly increased compressive stiffness compared with the intact condition and the interbody spacer alone (P ≤ 0.001). Conclusions: The WaveD alone significantly reduced ROM during flexion–extension while maintaining the axial compressive stiffness. CSR, PSR, and CSR/PSR hybrid constructs were all effective in augmenting the expandable interbody spacer system and improving its stability

Biomechanical Effects Of An Oblique Lumbar Peek Cage And Posterior Augmentation

Objective: Lumbar interbody spacers are widely used in lumbar spinal fusion. The goal of this study is to analyze the biomechanics of a lumbar interbody spacer (Clydesdale Spinal System, Medtronic Sofamor Danek, Memphis, Tennessee, USA) inserted via oblique lumbar interbody fusion (OLIF) or direct lateral interbody fusion (DLIF) approaches, with and without posterior cortical screw and rod (CSR) or pedicle screw and rod (PSR) instrumentation. Methods: Lumbar human cadaveric specimens (L2–L5) underwent nondestructive flexibility testing in intact and instrumented conditions at L3–L4, including OLIF or DLIF, with and without CSR or PSR. Results: OLIF alone significantly reduced range of motion (ROM) in flexion-extension (P = 0.005) but not during lateral bending or axial rotation (P ≥ 0.63). OLIF alone reduced laxity in the lax zone (LZ) during flexion-extension (P \u3c 0.001) but did not affect the LZ during lateral bending or axial rotation (P ≥ 0.14). The stiff zone (SZ) was unaffected in all directions (P ≥ 0.88). OLIF plus posterior instrumentation (cortical, pedicle, or hybrid) reduced the mean ROM in all directions of loading but only significantly so with PSR during lateral bending (P = 0.004), without affecting the compressive stiffness (P \u3e 0.20). The compressive stiffness with the OLIF device without any posterior instrumentation did not differ from that of the intact condition (P = 0.97). In terms of ROM, LZ, or SZ, there were no differences between OLIF and DLIF as standalone devices or OLIF and DLIF with posterior instrumentation (CSR or PSR) (P \u3e 0.5). Conclusions: OLIF alone significantly reduced mobility during flexion-extension while maintaining axial compressive stiffness compared with the intact condition. Adding posterior instrumentation to the interbody spacer increased the construct stability significantly, regardless of cage insertion trajectory or screw type

Comparing The Biomechanical Stability Of Cortical Screw Trajectory Versus Standard Pedicle Screw Trajectory For Short- And Long-Segment Posterior Fixation In 3-Column Thoracic Spinal Injury

Background: Information on the performance of posterior fixation with cortical screw (CS) versus pedicle screw (PS) trajectories for stabilizing thoracolumbar burst fractures is limited. Therefore, we sought to analyze stability with CS versus PS in short- and long-segment fixations using a 3-column spinal injury model. Methods: Nondestructive flexibility tests: (1) intact, (2) intact + short fixation, (3) intact + long fixation, (4) after burst fracture, (5) short fixation + burst fracture, and (6) long fixation + burst fracture using thoracic spine segments (7 CS, 7 PS). Results: With CS, the range of motion (ROM) was significantly greater with short-segment than with long-segment fixation in all directions, with and without burst fracture (P ≤ .008). With PS and burst fracture, ROM was significantly greater with short fixation during lateral bending and axial rotation (P, .006), but not during flexion-extension (P = .10). Groups with CS versus PS were not significantly different after burst fracture during flexion-extension and axial rotation, with short (P ≥ .58) or long fixation (P ≥ .17). During lateral bending, ROM was significantly greater with CS versus PS, without burst fracture (long fixation, P = .02) and with burst fracture (short and long fixation, P ≤ .001). Conclusions: CS trajectory is a valid alternative to PS trajectory for thoracic spine fixation in 3-column spinal injuries, and long-segment fixation is superior to short-segment fixation with either

Biomechanics of Nested Transforaminal Lumbar Interbody Cages.

BACKGROUND: Arthrodesis is optimized when the structural graft occupies most of the surface area within a disc space. The transforaminal corridor inherently limits interbody size. OBJECTIVE: To evaluate the biomechanical implications of nested interbody spacers (ie, a second curved cage placed behind a first) to increase disc space coverage in transforaminal approaches. METHODS: Seven lumbar human cadaveric specimens (L3-S1) underwent nondestructive flexibility and axial compression testing intact and after transforaminal instrumentation at L4-L5. Specimens were tested in 5 conditions: (1) intact, (2) interbody, (3) interbody plus bilateral pedicle screws and rods (PSR), (4) 2 nested interbodies, and (5) 2 nested interbodies plus PSR. RESULTS: Mean range of motion (ROM) with 1 interbody vs 2 nested interbodies, respectively, was: flexion, 101% vs 85%; extension, 97% vs 92%; lateral bending, 127% vs 132%; and axial rotation, 145% vs 154%. One interbody and 2 nested interbodies did not differ significantly by loading mode (P \u3e .10). With PSR, ROM decreased significantly compared with intact, but not between interbody and interbody plus PSR or 2 interbodies plus PSR (P \u3e .80). Mean vertical height during compressive loading (ie, axial compressive stiffness) was significantly different with 2 nested interbodies vs 1 interbody alone (P \u3c .001) (compressive stiffness, 89% of intact vs 67% of intact, respectively). CONCLUSION: Inserting a second interbody using a transforaminal approach is anatomically feasible and nearly doubles the disc space covered without affecting ROM. Compressive stiffness significantly increased with 2 nested interbodies, and foraminal height increased. Evaluation of the clinical safety and efficacy of nested interbodies is underway

A survey of intracranial aneurysm treatment practices among United States physicians

BACKGROUND: Recent surveys have failed to examine cerebrovascular aneurysm treatment practices among US physicians. OBJECTIVE: To survey physicians who are actively involved in the care of patients with cerebrovascular aneurysms to determine current aneurysm treatment preferences. METHODS: A 25-question SurveyMonkey online survey was designed and distributed electronically to members of the Society of NeuroInterventional Surgery, Society of Vascular and Interventional Neurology, and the American Association of Neurological Surgeons/Congress of Neurological Surgeons Combined Cerebrovascular Section. RESULTS: 211 physicians completed the survey. Most respondents recommend endovascular treatment as the first-line management strategy for most ruptured (78%) and unruptured (71%) aneurysms. Thirty-eight per cent of respondents indicate that they routinely treat all patients with subarachnoid hemorrhage regardless of grade. Most physicians use the International Study of Unruptured Intracranial Aneurysms data for counseling patients on natural history risk (80%); a small minority (11%) always or usually recommend treatment of anterior circulation aneurysms of \u3c5 mm. Two-thirds of respondents continue to recommend clipping for most middle cerebral artery aneurysms, while most (51%) recommend flow diversion for wide-necked internal carotid artery aneurysms. Follow-up imaging schedules are highly variable. Neurosurgeons at academic institutions and those practicing longer were more likely to recommend clipping surgery for aneurysms (p\u3c0.05). CONCLUSIONS: This survey demonstrates considerable variability in patient selection for intracranial aneurysm treatment, preferred treatment strategies, and follow-up imaging schedules among US physicians

Geoeconomic variations in epidemiology, ventilation management, and outcomes in invasively ventilated intensive care unit patients without acute respiratory distress syndrome: a pooled analysis of four observational studies

Background: Geoeconomic variations in epidemiology, the practice of ventilation, and outcome in invasively ventilated intensive care unit (ICU) patients without acute respiratory distress syndrome (ARDS) remain unexplored. In this analysis we aim to address these gaps using individual patient data of four large observational studies. Methods: In this pooled analysis we harmonised individual patient data from the ERICC, LUNG SAFE, PRoVENT, and PRoVENT-iMiC prospective observational studies, which were conducted from June, 2011, to December, 2018, in 534 ICUs in 54 countries. We used the 2016 World Bank classification to define two geoeconomic regions: middle-income countries (MICs) and high-income countries (HICs). ARDS was defined according to the Berlin criteria. Descriptive statistics were used to compare patients in MICs versus HICs. The primary outcome was the use of low tidal volume ventilation (LTVV) for the first 3 days of mechanical ventilation. Secondary outcomes were key ventilation parameters (tidal volume size, positive end-expiratory pressure, fraction of inspired oxygen, peak pressure, plateau pressure, driving pressure, and respiratory rate), patient characteristics, the risk for and actual development of acute respiratory distress syndrome after the first day of ventilation, duration of ventilation, ICU length of stay, and ICU mortality. Findings: Of the 7608 patients included in the original studies, this analysis included 3852 patients without ARDS, of whom 2345 were from MICs and 1507 were from HICs. Patients in MICs were younger, shorter and with a slightly lower body-mass index, more often had diabetes and active cancer, but less often chronic obstructive pulmonary disease and heart failure than patients from HICs. Sequential organ failure assessment scores were similar in MICs and HICs. Use of LTVV in MICs and HICs was comparable (42·4% vs 44·2%; absolute difference -1·69 [-9·58 to 6·11] p=0·67; data available in 3174 [82%] of 3852 patients). The median applied positive end expiratory pressure was lower in MICs than in HICs (5 [IQR 5-8] vs 6 [5-8] cm H2O; p=0·0011). ICU mortality was higher in MICs than in HICs (30·5% vs 19·9%; p=0·0004; adjusted effect 16·41% [95% CI 9·52-23·52]; p&lt;0·0001) and was inversely associated with gross domestic product (adjusted odds ratio for a US$10 000 increase per capita 0·80 [95% CI 0·75-0·86]; p&lt;0·0001). Interpretation: Despite similar disease severity and ventilation management, ICU mortality in patients without ARDS is higher in MICs than in HICs, with a strong association with country-level economic status