Retrospective evaluation of percutaneous 3D-navigated screw fixation for fragility fractures of the sacrum: technical notes and four-year experience.

The incidence of fragility fractures of the sacrum is increasing due to demographic changes. In this study, we introduce the 3D-navigated monoportal percutaneous sacroiliac screw fixation (PSS) as a technical advancement for treating fragility fractures of the sacrum. We included all patients who underwent the 3D-navigated monoportal PSS for fragility fractures of the sacrum. The fractures were classified using the Fragility Fractures of the Pelvis score (FFP). We provide a step-by-step illustration of the surgical technique. The objective of this study was to assess the feasibility and safety of the investigated technique. Forty-six patients (36 female, 10 male) with a median age of 81.5 years were included in the study. The fracture classification revealed 23 FFP2 (50%), 5 FFP3 (11%), and 18 FFP4 (39%) fractures. In 35 cases (76%), only transsacral screws were implanted in S1 and S2, with an average incision-to-suture time of 52.6 min. The remaining eleven patients underwent additional anterior pelvic ring fixation, lumbar instrumentation, or kyphoplasty. There were no instances of nerve root, vascular, or pelvic organ injuries. The median postoperative in-hospital stay was six days. Out of the 36 patients who were followed up, four patients required revision surgery due to screw loosening. No significant risk factor for screw loosening was identified in the multiple regression analysis. The presented monoportal PSS technique for fragility fractures of the sacrum is a promising minimally invasive approach with a low complication rate and excellent short-term outcomes.

Comparison of plug-based versus suture-based vascular closure for large-bore arterial access: a collaborative meta-analysis of observational and randomized studies.

BACKGROUND: Large-bore arteriotomies can be percutaneously closed with suture-based or plug-based vascular closure device (VCD) strategies. The efficacy of both techniques remains controversial. AIMS: We conducted a meta-analysis of comparative studies between both VCD strategies, focusing on the most commonly applied VCDs (MANTA and ProGlide). METHODS: We searched MEDLINE, the Cochrane Central Register of Controlled Trials and Google scholar for observational studies (OS) and randomized controlled trials (RCT) comparing vascular closure with the MANTA-based and the ProGlide-based technique. The principal endpoint of this analysis was access-site related vascular complications. Both study types were analyzed separately. RESULTS: Access-site related vascular complications were less frequent after vascular closure with the MANTA technique in the analysis of OS (RR 0.61 [95%CI 0.43-0.89], p = 0.01, I2 = 0%), but more frequent in the analysis of RCT data (RR 1.70 [95%CI 1.16-2.51], p = 0.01, I2 = 0%). Both data sets provided no significant difference between the VCD techniques in terms of overall bleeding events (OS: RR 0.57 [95%CI 0.32-1.02], p = 0.06, I2 = 70%; and RCT: RR 1.37 [95%CI 0.82-2.28], p = 0.23, I2 = 30%). RCT data showed that endovascular stenting or vascular surgery due to VCD failure occurred more often after MANTA application (RR 3.53 [95%CI 1.07-11.33], p = 0.04, I2 = 0%). CONCLUSIONS: While OS point to favorable outcomes for large-bore vascular closure with the MANTA-based technique, RCT data show that this strategy is associated with more access-site related vascular complications as well as endovascular stenting or vascular surgery due to device failure compared with the ProGlide-based technique.

Impact of moderate or severe left ventricular outflow tract calcification on clinical outcomes of patients with severe aortic stenosis undergoing transcatheter aortic valve implantation with self- and balloon-expandable valves: a post hoc analysis from the SOLVE-TAVI trial.

BACKGROUND: Left ventricular outflow tract (LVOT) calcification has been associated with worse outcomes in patients undergoing transcatheter aortic valve implantation (TAVI) and may influence the selection of prosthetic valve type. AIMS: We aimed to evaluate the impact of LVOT calcification on outcomes after TAVI with a self-expanding valve (SEV) versus a balloon-expandable valve (BEV). METHODS: Patients of the SOLVE-TAVI trial, randomised to Edwards SAPIEN 3 or Medtronic Evolut R, were divided according to LVOT calcification into no/mild (≤1 calcium nodule extending <5 mm and covering <10% of the LVOT perimeter) and moderate/severe LVOT calcification groups. The primary endpoint was a composite of death, stroke, moderate/severe paravalvular regurgitation, permanent pacemaker implantation and annulus rupture at 30 days. Additional endpoints included all-cause and cardiovascular mortality at 1 year. RESULTS: Out of 416 eligible patients, moderate/severe LVOT calcification was present in 143 (34.4%). Moderate/severe LVOT calcification was associated with significantly longer fluoroscopy time and higher rates of pre- and post-dilation. Regardless of the LVOT calcification group, there was no significant difference in the primary endpoint associated with the valve type (no/mild LVOT calcification group: SEV 25.0% vs BEV 27.0%; hazard ratio [HR] 1.10, 95% confidence interval [95% CI]: 0.68-1.73; p=0.73 and moderate/severe LVOT calcification group: SEV 25.0% vs BEV 19.4%; HR 0.76, 95% CI: 0.38-1.61; p=0.49), no significant interaction between LVOT calcification and valve type (pint=0.29) and no differences between SEV vs BEV within LVOT calcification groups regarding 1-year all-cause and cardiovascular mortality. CONCLUSIONS: Moderate/severe LVOT calcification was associated with longer fluoroscopy time and an increased need for pre- and post-dilation, but not with a higher incidence of early and mid-term adverse clinical outcomes, regardless of valve type. (ClinicalTrials.gov: NCT02737150).

Comparison of radiation exposure and surgery time between an intraoperative CT with automatic surface registration and a preoperative CT with manual surface registration in navigated spinal surgeries.

PURPOSE: This retrospective matched case-control study was conducted to compare two CT based surgery techniques for navigated screw placement in spinal surgery, whether a reduction of radiation exposure and surgery time could be achieved. METHODS: We matched cases treated with an intraoperative CT (iCT), regarding the type and number of implants, with cases treated with a preoperative CT (pCT) of one main surgeon. Outcome measures were radiation exposure due to intraoperative control x-rays, radiation exposure due to CT images, and the duration of surgery. RESULTS: The required radiation exposure could be significantly reduced in the iCT group. For the intraoperative control X-rays by 69% (median (MED) 88.50/standard deviation (SD) 107.84 and MED 286.00/SD 485.04 for iCT and pCT respectively-in Gycm2; p < 0.001) and for the CT examinations by 25% (MED 317.00/SD 158.62 and MED 424.50/SD 225.04 for iCT and pCT respectively-in mGycm; p < 0.001) with no significant change in surgery time. The correlation between the number of segments fused and the necessary surgery time decreased significantly for the iCT group (Pearson product-moment-correlation: r = 0.569 and r = 0.804 for iCT and pCT respectively; p < 0.05). CONCLUSION: The results show that spinal navigation using an intraoperative CT with automatic registration compared to a preoperative CT and intraoperative manual surface registration, allows a significant reduction of radiation exposure, without prolonged surgery time. A significant benefit regarding cut-to-suture-time can be gained with surgeries of a larger scale.

Radial versus femoral approach for left ventricular endomyocardial biopsy.

AIMS: Despite the widespread use of the radial approach in coronary interventions, left ventricular endomyocardial biopsy (LV-EMB) is most frequently performed via the femoral artery. We sought to assess the feasibility and safety of radial compared to femoral access in a large cohort of patients undergoing LV-EMB. METHODS AND RESULTS: Data from 264 patients who underwent LV-EMB in Germany, Portugal, Japan and Canada were collected. Clinical, procedural, safety and feasibility data were evaluated and compared between the two groups. LV-EMB was successfully performed by the radial approach in 129 (99%) of 130 and in 134 (100%) patients by the femoral access. Patients in the radial group were older (mean age 55.7 versus 44.3 years) and were more likely to have moderate-severe mitral regurgitation (27.7% versus TF 0%). Sheathless guides were used in 108 (83.1%) of the radial and 2 (1.5%) of the femoral patients, so the mean guiding catheter size (radial 7.0±1.0 Fr versus femoral 8.0±0.0 Fr) was significantly smaller in the radial group (p<0.001). Mild or moderate radial artery spasm occurred in 13 (10.0%) patients but only one (0.8%) patient required conversion to femoral access due to severe spasm. No access site-related complications were reported in the radial group, while 11 (8.2%) patients in the femoral group had access-site haematomas (p=0.001). There were no major complications (mitral valve injury, pericardial tamponade requiring intervention, cerebrovascular accidents, persistent high-degree atrioventricular block, major bleeding or death) in either group. CONCLUSIONS: The radial approach for LV-EMB appears to be safe and associated with a high success rate while possibly leading to fewer access-site bleeding complications compared to the femoral access. The results of this international multicentre study support the radial approach for LV-EMB and further inspire the expansion of "radial first" in the field of interventional cardiology.

A Three-Arm Randomized Trial of Different Renal Denervation Devices and Techniques in Patients With Resistant Hypertension (RADIOSOUND-HTN).

BACKGROUND: Both radiofrequency and ultrasound endovascular renal sympathetic denervation (RDN) have proven clinical efficacy for the treatment of hypertension. We performed a head-to-head comparison of these technologies. METHODS: Patients with resistant hypertension were randomly assigned in a 1:1:1 manner to receive either treatment with (1) radiofrequency RDN of the main renal arteries; (2) radiofrequency RDN of the main renal arteries, side branches, and accessories; or (3) an endovascular ultrasound-based RDN of the main renal artery. The primary end point was change in systolic daytime ambulatory blood pressure at 3 months. RESULTS: Between June 2015 and June 2018, 120 patients were enrolled (mean age, 64±9 years±SD; mean daytime blood pressure, 153/86±12/13 mm Hg). Of these, 39 were randomly assigned to radiofrequency main renal artery ablation, 39 to combined radiofrequency ablation of the main artery and branches, and 42 to ultrasound-based treatment. Baseline daytime blood pressure, clinical characteristics, and treatment were well balanced between the groups. At 3 months, systolic daytime ambulatory blood pressure decreased by 9.5±12.3 mm Hg ( P<0.001) in the whole cohort. Although blood pressure was significantly more reduced in the ultrasound ablation group than in the radiofrequency ablation group of the main renal artery (-13.2±13.7 versus -6.5±10.3 mm Hg; mean difference, -6.7 mm Hg; global P=0.038 by ANOVA, adjusted P=0.043), no significant difference was found between the radiofrequency ablation groups (-8.3±11.7 mm Hg for additional side branch ablation; mean difference, -1.8 mm Hg; adjusted P>0.99). Similarly, the blood pressure reduction was not found to be significantly different between the ultrasound and the side branch ablation groups. Frequencies of blood pressure response ≥5 mm Hg were not significantly different (global P=0.77). CONCLUSIONS: In patients with resistant hypertension, endovascular ultrasound-based RDN was found to be superior to radiofrequency ablation of the main renal arteries only, whereas a combined approach of radiofrequency ablation of the main arteries, accessories, and side branches was not. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT02920034.

Predictors for profound blood pressure response in patients undergoing renal sympathetic denervation.

BACKGROUND: Renal sympathetic denervation (RDN) as treatment for hypertension shows highly variable results. Although some patients do not show any blood pressure (BP) change and in most patients a BP reduction of at least 5 mmHg can be found, some show a reduction at least 20 mmHg. We sought to identify predictors for such a profound BP response. METHODS: Profound BP response was defined as drop of at least 20 mmHg in daytime systolic ambulatory BP measurement (ABPM) 3 months after catheter-based RDN. Three different denervation devices were used for RDN, and pulse wave velocity was determined invasively in a subgroup of patients. RESULTS: One hundred and ninety consecutive patients were included in this analysis. Profound BP response was found in 33 patients. Patients with profound BP response were younger (P = 0.04), presented with higher baseline ABPM values (P < 0.001), were treated with ultrasound-based RDN and received more often a combined treatment with two different diuretics (P = 0.005 for both). After 3 months, a treatment target of daytime BP less than 135 mmHg could be achieved more frequently in patients with profound BP response (61 vs. 17%, P < 0.001). Age, use of ultrasound RDN, combined diuretic therapy and baseline BP independently predicted pronounced BP reduction. A second multivariate logistic regression model including pulse wave velocity if available identified baseline BP, pulse wave velocity and use of ultrasound denervation as independent predictors for profound BP response. CONCLUSION: Younger vascular age, higher baseline BP, treatment with ultrasound RDN and combined diuretic therapy were found as predictors for a pronounced BP reduction following RDN, improving BP control at follow-up.

[Subaxial Cervical Spine Injuries: Treatment Recommendations of the German Orthopedic and Trauma Society]. / Therapieempfehlungen zur Versorgung von Verletzungen der subaxialen Halswirbelsäule.

In a consensus process during four sessions in 2016, the working group "lower cervical spine" of the German Society for Orthopedic and Trauma Surgery (DGOU), formulated "Therapeutic Recommendations for the Lower Cervical Spine", taking into consideration the current literature. Therapeutic goals are a permanently stable, painless cervical spine and the protection against secondary neurologic damage while retaining the greatest possible amount of motion and spinal profile. Due to its ease of use and its proven good reliability, the AOSpine classification for subaxial cervical injuries should be used. The Canadian C-Spine Rule is recommended as a clinical decision rule whether to perform imaging or not. If a structural or unstable injury is suspected by patient history or clinical findings, a spiral CT scan of the cervical spine is the favoured diagnostic modality. Conventional X-ray is reserved for patients in whom there is no "dangerous mechanism of injury". MR imaging is recommended in case of unexplained neurologic deficit, prior to closed reduction and open posterior surgery and to exclude disco-ligamentous injuries. Urgency of MR imaging depends on the specific findings. CT angiography is recommended in higher-grade facet joint injuries or in the presence of vertebra-basilar symptoms. Flexion-extension imaging is recommended only as a physician-guided dynamic fluoroscopy, when an unstable lesion is still suspected. The therapeutic strategy is mainly dependent on morphologic criteria, which are described using the AOSpine classification. A0-injuries are treated conservatively. A1- and A2-injuries are treated conservatively in the majority of cases, and in single cases a gross kyphotic deformity might indicate surgical stabilisation. A3-injuries do indicate a surgical therapy in the majority of cases, but certain cases might be treated conservatively. A4-fractures as well as B- and C-type injuries are to be treated surgically. Most injuries can be treated by anterior plate stabilisation with interbody support; when a complete burst fracture is present, corpectomy and vertebral body replacement is necessary. In certain cases, an additive posterior or pure posterior instrumentation might be possible or even mandatory. In most of these cases, lateral mass screws are sufficient; when pedicle screws are applied in C3 to C6, a 3D-navigation system is recommended. Injuries in an ankylosing spine (M3-modifier) should be treated preferably from posterior with long-segment instrumentation.