Implantation Strategy Research Articles

Insights into endometrial function: What can we learn from species with diverse implantation strategies?

Insights into endometrial function: What can we learn from species with diverse implantation strategies?

Simultaneous hybrid off-pump coronary artery bypass grafting and transcatheter aortic valve implantation in elderly patients.

Optimal strategy for transcatheter aortic valve implantation (TAVI) in patients with coronary artery disease (CAD) is unresolved. We evaluated the surgical outcomes of hybrid coronary artery bypass grafting (CABG) and TAVI in elderly patients. We retrospectively evaluated patients who underwent simultaneous TAVI and CABG at Wakayama Medical University, Japan. All patients underwent off-pump CABG (OPCAB) including minimally invasive cardiac surgery (MICS-CABG). In an earlier period, OPCAB + transfemoral TAVI (TF-TAVI) was the only method used, while in a later period, we introduced MICS-CABG and alternative approaches for TAVI. Twenty-seven patients were enrolled, the average age was 83.6 ± 5.1years. In the MICS-CABG and TAVI group, average patient age was higher (87.0 ± 3.1years) than in the earlier group. Thirty-day and in-hospital mortalities were zero. Incomplete revascularization rate was 33.3% and one patient required percutaneous coronary intervention after the operation. Graft patency rate was 100%. In MICS-CABG group, the number of distal anastomoses was smaller (1.29, range 1-2), but the number of days required to re-starting walking and postoperative hospital stay were shorter, and the rate of discharge to home was higher (100%) than in the other groups. Although 33.3% of patients did not achieve complete revascularization, there was no 30-day or in-hospital mortality. TAVI and hybrid OPCAB, including MICS-CABG, were suggested to be feasible treatment in elderly patients.

Analysis of methods for heart failure

Heart Failure (HF) is one of the major causes of death from various heart diseases and is a common complex clinical syndrome. HF has a high incidence and its 5-year survival rate is similar to that of patients with malignant tumors, which has a serious impact on the quality of life of patients and has become a major public health problem of worldwide concern. At this stage, the clinical treatment of HF is still mainly based on drug therapy. As clinical research progresses, more and more new HF therapeutic drugs are being introduced one after another, new uses of drugs are being discovered and clinical options for drug use are becoming more and more diverse. The drug therapy for HF is also changing from monotherapy to multi-target and multi-mechanism combined mode of action. Innovative mechanical therapy products are also bringing new strategies to the treatment of HF. This article reviews the medication treatment and device implantation strategies for the clinical treatment of HF.

Targeted left ventricular lead positioning to the site of latest activation in cardiac resynchronization therapy: a systematic review and meta-analysis.

Several studies have evaluated the use of electrically- or imaging-guided left ventricular (LV) lead placement in cardiac resynchronization therapy (CRT) recipients. We aimed to assess evidence for a guided strategy that targets LV lead position to the site of latest LV activation. A systematic review and meta-analysis was performed for randomized controlled trials (RCTs) until March 2023 that evaluated electrically- or imaging-guided LV lead positioning on clinical and echocardiographic outcomes. The primary endpoint was a composite of all-cause mortality and heart failure hospitalization, and secondary endpoints were quality of life, 6-min walk test (6MWT), QRS duration, LV end-systolic volume, and LV ejection fraction. We included eight RCTs that comprised 1323 patients. Six RCTs compared guided strategy (n = 638) to routine (n = 468), and two RCTs compared different guiding strategies head-to-head: electrically- (n = 111) vs. imaging-guided (n = 106). Compared to routine, a guided strategy did not significantly reduce the risk of the primary endpoint after 12-24 (RR 0.83, 95% CI 0.52-1.33) months. A guided strategy was associated with slight improvement in 6MWT distance after 6 months of follow-up of absolute 18 (95% CI 6-30) m between groups, but not in remaining secondary endpoints. None of the secondary endpoints differed between the guided strategies. In this study, a CRT implantation strategy that targets the latest LV activation did not improve survival or reduce heart failure hospitalizations.

Using pre-surgical suspicion to guide insula implantation strategy

RationaleInsular epilepsy can be a challenging diagnosis due to overlapping semiology and scalp EEG findings with frontal, temporal, and parietal lobe epilepsies. Stereotactic electroencephalography (sEEG) provides an opportunity to better localize seizure onset. The possibility of improved localization is balanced by implantation risk in this vascularly rich anatomic region. We review both safety and pre-implantation factors involved in insular electrode placement across four years at an academic medical center. MethodsPresurgical data, operative reports, and invasive EEG summaries were retrospectively reviewed for patients undergoing invasive epilepsy monitoring on the insula from 2016 through 2019. EEG reports were reviewed to record the presence of insula ictal and interictal involvement. We recorded which presurgical findings suggested insular involvement (insula lesion on MRI, insula changes on PET/SPECT/scalp EEG, characteristic semiology, or history of failed anterior temporal lobectomy). The likelihood of pre-sEEG insular onset was categorized as low suspicion if no presurgical findings were present (“rule out”), moderate suspicion if one finding was present, and high suspicion if two or more findings were present. Results76 patients received 189 insular electrodes as part of their implantation strategy for 79 surgical cases. Seven patients (8.9%) had insular ictal onset. One clinically significant complication (left hemiparesis) occurred in a patient with moderate suspicion for insular onset. There were 38 low suspicion cases, 36 moderate suspicion cases, and 5 high suspicion cases for pre-sEEG insula ictal onset. Two low suspicion (5.3%), three moderate suspicion (8.6%), and two high suspicion (40%) cases had insular ictal onset. ConclusionsThe insula can safely receive sEEG. Having two or more presurgical factors indicating insular onset is a strong, albeit incomplete, predictor of insular seizure onset. Using pre-implantation clinical findings can offer clinicians predictive value for targeting the insula during invasive EEG monitoring.

Electrocardiographic Predictors of Complete Heart Block During Right Ventricular Lead Implantation in Patients Who Underwent Cardiac Resynchronization Therapy

Cardiac resynchronization therapy (CRT) device procedures have their own complications in addition to the complications associated with standard pacemaker implantations. This study aimed to analyze the predictors of the right bundle branch injury resulting in complete heart block (CHB) during right ventricular (RV) lead implantation in patients who underwent CRT with defibrillator. We conducted an observational study of consecutive 790 patients who underwent CRT with defibrillator device implantation at our institution from 2010 to 2022. Relevant clinical information and complete data regarding the echocardiographic data, implantation procedure, and clinical follow-up were collected into a computerized database. A total of 29 patients (3.7%) had CHB during RV lead implantation. In multivariate analysis, left axis deviation (odds ratio [OR] 2.408, 95% confidence interval [CI] 1.025 to 5.658, p=0.044), QRS width (OR 1.022, 95% CI 1.001 to 1.043, p=0.035) and QRS alternans (OR 4.214, 95% CI 1.788 to 9.930, p=0.001) were found independently related to right bundle branch injury resulting in CHB development during RV lead implantation. In conclusion, left axis deviation, QRS width, and QRS alternans were associated with a higher rate of CHB, and these findings provide insight into optimal and safe CRT device implantation strategies based on preprocedural characteristics.

Cardiac magnetic resonance for prophylactic implantable-cardioverter defibrillator therapy international study in ischemic cardiomyopathy: international DERIVATE-ICM Registry

Abstract Funding Acknowledgements Type of funding sources: None. Background Implantable cardioverter–defibrillator (ICD) therapy is the most effective sudden cardiac death (SCD) event prophylactic-strategy in ischemic cardiomyopathy (ICM) patients with transthoracic echocardiographic (TTE) left ventricular ejection fraction (LVEF) ≤35%. This approach has been recently questioned due to the low rate of ICD interventions in patients who received implantation and the not negligible percentage of patients who experienced SCD event despite not fulfilling criteria for implantation. Purpose The DERIVATE-ICM registry (RCT#NCT03352648) is an international, multicenter and multivendor study to assess the net reclassification improvement (NRI) for the indication of ICD implantation by the use of cardiac magnetic resonance (CMR) as compared to standard of care based on TTE in ICM patients. Methods We enrolled 861 ICM patients (mean age 65±11 years, 86% male) with chronic heart failure and TTE-LVEF<50%. Major adverse arrhythmic cardiac events (MAACE), defined as the combination of SCD, aborted SCD event, and sustained ventricular tachycardia were the primary endpoint. Independent predictors were used to calculate a CMR risk score for each patient. Risk levels were defined as low (quantile 1 [Q1]), medium (Q2 and Q3) and high (Q4). Results During a median follow-up of 1054 days, MAACE occurred in 88 (10.2%). Left ventricular end-diastolic volume index (HR: 1.007, 95%CI:1.000–1.011, p = 0.050), CMR-LVEF (HR: 0.972, 95%CI: 0.945–0.999, p = 0.045) and late gadolinium enhancement (LGE) mass (HR: 1.010, 95%CI: 1.002–1.018, p = 0.015) were independent predictors of MAACE. Based on the multivariable analysis, CMR weighted risk score was developed according to the following equation [0.005 * EDV/BSA (mL/m²) – 0.029 * LVEF (%) + 0.010 * LGE ischemic mass (g)]. Figure 1 (top) shows the Kaplan-Meier curves according to the guidelines-based TTE-LVEF model and the CMR risk score. Moreover, the table of reclassification of the CMR versus TTE predictive model is reported in Figure 1 (bottom). This multiparametric CMR weighted predictive derived score effectively identifies subjects at high risk for MAACE as compared to TTE-LVEF cut-off of 35% with a NRI of 31.7% (p = 0.007). The distribution of CMR predictive score in patients with TTE-LVEF≤35% (panel A) and with TTE LVEF>35% (panel C) is represented in Figure 2, together with the event rate redistribution according to the CMR risk score (panel B and panel D). Conclusions The DERIVATE-ICM study is the first large multicenter registry testing the additional value of CMR to stratify the risk for MAACE in a large cohort of ICM patients as compared to standard of care. This model identifies a large number of patients with TTE-LVEF<35% at low risk of SCD event and on the other side it identifies a subset of patients who are at high risk of MAACE despite TTE-LVEF≥35%. Further randomized trials to test a CMR guided strategy for ICD implantation versus standard of care are now needed.

Patterned Mussel‐Inspired Freestanding Membranes as Efficient Delivery Device of Therapeutic Stem Cells for Cartilage Repair

Articular cartilage injuries are currently one of the world's top health concerns owing to its limited capacity of self‐renewal, thus raising to the economic burden in the healthcare system. Cell implantation strategies resorting to a suitable delivery platform hold a great promising approach to increase cell retention to be further supplied in a sufficient amount to the cartilage defects. So far, macromolecular engineering toolboxes for designing cell‐carrier devices with on‐demand cell delivery efficiency are rarely reported. Herein, anisotropically patterned mussel‐inspired membranes, comprising oppositely charged marine‐origin biopolymers (e.g., chitosan and alginate) combined in a multilayered fashion with catechol‐functionalized hyaluronic acid (DOPA‐HA), through electrostatically driven layer‐by‐layer (LbL) assembly approach, are developed. The seamless combination of nanotopography and catechol molecular cues in one single platform significantly augments ASC/TERT1 adhesion at the patterned DOPA‐HA membrane surface. These highest cell density membranes are further applied onto human chondral discs ex vivo models to evaluate their capability to act as cell delivery vehicles. Results show the successful cell migration and retention at cartilage surface, wherein they spread to inhabit both superficial empty lacunae and furrows. Therefore, the present study supplies an important strategy for designing cell delivery vehicles to be applied on cell‐based therapies.

Permutations in pacer wire implantation in patients evaluated for transcatheter tricuspid valve interventions.

Pacer wire induced tricuspid regurgitation is not well-understood. The mechanisms behind pacer wired induced tricuspid regurgitation have not been clearly defined. This clinical vignette sets to identify different technical mechanisms behind cardiac lead induced tricuspid regurgitation to help optimize cardiac lead implantation strategies for future device implantation.

Operative Technique and Nuances for the Stereoelectroencephalographic (SEEG) Methodology Utilizing a Robotic Stereotactic Guidance System.

The SEEG methodology has gained favor in North America over the last decade as a means of localizing the epileptogenic zone (EZ) prior to epilepsy surgery. Recently, the application of a robotic stereotactic guidance system for implantation of SEEG electrodes has become more popular in many epilepsy centers. The technique for the use of the robot requires extreme precision in the pre-surgical planning phase and then the technique is streamlined during the operative portion of the methodology, as the robot and surgeon work in concert to implant the electrodes. Herein is detailed precise operative methodology of using the robot to guide implantation of SEEG electrodes. A major limitation of the procedure, namely its heavy reliance on the ability to register the patient to a preoperative volumetric magnetic resonance image (MRI), is also discussed. Overall, this procedure has been shown to have a low morbidity rate and an extremely low mortality rate. The use of a robotic stereotactic guidance system for the implantation of SEEG electrodes is an efficient, fast, safe, and accurate alternative to conventional manual implantation strategies.

Active Site Implantation for Ni(OH)2 Nanowire Network Achieves Superior Hybrid Seawater Electrolysis at 1 A cm−2 with Record‐Low Cell Voltage

AbstractDirect seawater electrolysis provides a grand blueprint for green hydrogen (H2) technology, while the high energy consumption has severely hindered its industrialization. Herein, a promising active site implantation strategy is reported for Ni(OH)2 nanowire network electrode on nickel foam substrate by Ru doping (denoted as RuNi(OH)2 NW2/NF), which can act as a dual‐function catalyst for hydrazine oxidation and hydrogen evolution, achieving an ultralow working potential of 114.6 mV to reach 1000 mA cm−2 and a small overpotential of 30 mV at 10 mA cm−2, respectively. Importantly, using the two‐electrode hydrazine oxidation assisted seawater electrolysis, it can drive a large current density of 500 mA cm−2 at 0.736 V with over 200 h stability. To demonstrate the practicability, a home‐made flow electrolyzer is constructed, which can realize the industry‐level rate of 1 A cm−2 with a record‐low voltage of 1.051 V. Theoretical calculations reveal that the Ru doping activates Ni(OH)2 by upgrading d‐band centers, which raises anti‐bonding energy states and thus strengthens the interaction between adsorbates and catalysts. This study not only provides a novel rationale for catalyst design, but also proposes a feasible strategy for direct alkaline seawater splitting toward sustainable, yet energy‐saving H2 production.

P63: Preemptive Temporary Right Ventricular Assist Device Implantation For Severe Biventricular Heart Failure: A Case Series

Purpose: We sought to investigate the clinical results of preemptive temporary right ventricular assist device (RVAD) placement with left ventricular assist device (LVAD) implantation for anticipated right ventricular failure. Methods: Patients at risk for right ventricular failure were identified by the heart team. After median sternotomy, Protec-duo (LivaNova, London, UK) dual-stage cannula was inserted from the right internal jugular vein under fluoroscopy guidance, and advanced into the pulmonary artery to the bifurcation of the main pulmonary artery. This was then connected to the venous drainage from the right atrium for cardio pulmonary bypass (CPB). After LVAD implantation, we connected the Protec-duo cannula to the RVAD with oxygenator, and weaned CPB (Figure). Results: A total of 11 patients have received BiVAD implantation with this technique. The median age of patients was 55 years [Interquartile range (IQR): 51 – 63.5] and all patients were male. 63.6 % (7/11) of the patients were INTERMACS profile 1 or 2. Preoperatively, the median pulmonary artery pulsatility index was 4.0 [1.5 – 4.9] and median right ventricular stroke work index was 454.1 g/m/beat/m2 [436.5 – 530.2]. Postoperatively, the oxygenators were removed on median postoperative day (POD) 3.5 [3 – 5]. Patients received mechanical ventilation for a median of 4 days [1.5 – 12] and RVADs were explanted on median POD 8 [7 – 19) with local anesthesia. Perioperative complications included delayed sternal closure [54.5% (6/11)], re-exploration for bleeding [18% (2/11)], acute kidney injury [36% (4/11)], and heparin induced thrombocytopenia [18% (2/11)]. 30-day mortality was 0% (0/11). Conclusion: Preemptive temporary RVAD implantation strategy for right heart failure post-LVAD showed acceptable clinical outcomes without any 30-day mortality.

Research on the implantation and dissemination strategy of short creative advertising videos in the new media era

Interconnections and communication between people in social media enhance the information dissemination. This is leveraged by the business firms by using the social media as advertising platform for their products, brands and services. As interactive multimedia is more captivating than other media forms, the short and creative advertising videos are recently used as effective marketing tool. This work proposes a framework that taps the features of the video advertisements along with social networking properties like network clusters and network degree to determine the transmission and retransmission of video between primary and secondary level clusters. The degradation in retransmission is estimated using the connections and their influence computed as connection coefficient between the nodes. The proposed framework is validated on Facebook advertisement videos by assessing its efficacy in dissemination and implementation of the products. The detailed experimentation reveals that the proposed model is much effective in determining the dissemination and implementation of the video content with the average mean square error of 0.24. The work is robust and versatile, that it could be deployed to other social media networks by customising the estimation of transmission and retransmission rate.

Stylet-driven vs. non-stylet-driven lead implantation for left bundle branch area pacing

Abstract Funding Acknowledgements Type of funding sources: None. Background Left bundle branch area pacing (LBBAP) is a novel pacing strategy, which overcomes limitations of right ventricular pacing. Conventional stylet-driven and non-stylet-driven leads have been used as a conduction system pacing lead. Procedural outcome data comparing both lead types are, however, scarce. Purpose To compare procedural outcomes during CSP device implantation with respect to the use of stylet-driven vs. non-stylet-driven leads. Methods We prospectively assessed 170 consecutive LBBAP lead implantation attempts at our center from 09/2021 to 11/2022. All implanters had previous experience with His-bundle pacing lead implantation using the non-stylet-driven lead and 91% of all systems were implanted by two high-volume device implanters. Successful conduction system pacing was established according to standard criteria (LBBAP: R-wave peak time in V6, V1-V6-interpeak interval, programmed stimulation or visibility of a left bundle potential) and pacing thresholds (<2V/0.5ms). The used leads in this analysis were the non-stylet-driven 3830 SelectSure lead (Medtronic, US) and the stylet-driven Solia (Biotronik, Germany), Ingevity+ (Boston Scientific, US) and Tendril STS (Abbott, US) lead. Patient selection and implantation strategy was at the operator’s discretion. Results Clinical baseline characteristics, echocardiography/ECG data and indications did not differ between patients, who received a stylet-driven or non-stylet-driven lead (table showing percentages and median values/interquartile ranges). Patients underwent implantation of a non-stylet driven 3830 SelectSure lead in 20% of cases and a stylet-driven lead in 80% of cases (Solia 76%, Ingevity+ 3%, Tendril STS 1%). Electrical outcome data did not differ between lead types. However, procedural success rate was significantly higher using stylet-driven leads (p=0.025) and a trend towards shorter overall intervention duration was observed as well (p=0.1). Conclusion Stylet-driven leads offer higher LBBAP lead implantation success rates while shortening implant duration.

Acute procedural outcomes of left bundle branch area pacing compared to His-bundle pacing

Abstract Funding Acknowledgements Type of funding sources: None. Background Conduction system pacing (CSP), encompassing left bundle branch area pacing (LBBAP) and His-bundle pacing (HBP), is a novel pacing strategy, which overcomes limitations of conventional right ventricular pacing. Feasibility and early safety of both strategies have been established previously. While HBP is mentioned as an alternative pacing strategy in the latest European and American pacing guidelines, implantation recommendations regarding LBBAP are scarce. Notably, HBP was described to be associated with a significantly higher procedural failure rate compared to LBBAP, making it potentially more contestable. Purpose To compare procedural outcomes after HBP and LBBAP lead implantation. Methods We prospectively assessed 303 consecutive CSP lead implantation attempts at our center from 08/2018 to 11/2022. 81% of all implantations were performed by two high-volume device implanters. Successful conduction system pacing was established according to standard criteria (HBP: QRS morphology, R-wave peak time in V6, programmed stimulation, visibility of a His potential; LBBAP: R-wave peak time in V6, V1-V6-interpeak interval, programmed stimulation or visibility of a left bundle potential) and pacing thresholds (HBP: <4.0V/1.0ms; LBBAP: <2V/0.5ms). Patient selection and the implantation strategy used was at the operator’s discretion. Results Patients with a HBP attempt were younger and had a narrower QRS complex but did not differ with respect to left or right ventricular function and dimension (table showing percentages and median values/interquartile ranges). LBBAP systems were more often implanted in lieu of CRT, whereas HBP systems were more commonly used in case of AV block without heart failure (table). Acute procedural success rate, overall procedure duration and fluoroscopy time were significantly better during LBBAP implantations (all p<0.001). Success rates, sensing values and capture thresholds (@1ms for HBP and @0.5ms for LBBAP) were superior in LBBAP systems, while achieved paced QRS duration was slightly shorter in HBP systems (table, figure 1). Conclusion Success rates and acute procedural outcomes favor implantation of LBBAP compared to HBP systems.

Stent deformations in the common iliac and iliofemoral veins as a result of hip flexion and extension

ObjectiveIn the present study, we characterized deformations of venous stents implanted into common iliac veins for nonthrombotic iliac vein lesions and iliofemoral veins for deep vein thrombosis due to hip movements commensurate with everyday activities such as walking, sitting, and stair climbing. MethodsPatients treated with iliofemoral venous stents were recruited from three centers and underwent imaging with two orthogonal two-dimensional projection radiographs. Stents in the common iliac veins and iliofemoral veins crossing the hip joint were imaged with the hip in 0°, 30°, 90° and −15°, 0°, and 30° positions, respectively. Using the radiographs, the three-dimensional geometries of the stents were constructed for each hip position, and the diametric and bending deformations between those positions were quantified. ResultsTwelve patients were included, and the findings showed that the common iliac vein stents experienced approximately twofold more local diametric compression with 90° hip flexion compared with 30° flexion. Also, iliofemoral vein stents crossing the hip joint experienced significant bending with hip hyperextension (−15°) but not with hip flexion. In both anatomic locations, maximum local diametric and bending deformations were in proximity with each other. ConclusionsStents implanted in the common iliac and iliofemoral veins exhibit greater deformation during high hip flexion and hyperextension, respectively, and iliofemoral venous stents interact with the superior ramus of the pubis during hyperextension. These findings suggest that device fatigue could be influenced by the type and level of patient physical activity, in addition to anatomic positioning, opening up the potential benefit of activity modification and the use of a careful implantation strategy. The proximity of maximum diametric and bending deformations means that simultaneous multimodal deformations should be considered for device design and evaluation.

A burst of genomic innovation at the origin of placental mammals mediated embryo implantation

The origin of embryo implantation in mammals ~148 million years ago was a dramatic shift in reproductive strategy, yet the molecular changes that established mammal implantation are largely unknown. Although progesterone receptor signalling predates the origin of mammals and is highly conserved in, and critical for, successful mammal pregnancy, it alone cannot explain the origin and subsequent diversity of implantation strategies throughout the placental mammal radiation. MiRNAs are known to be flexible and dynamic regulators with a well-established role in the pathophysiology of mammal placenta. We propose that a dynamic core microRNA (miRNA) network originated early in placental mammal evolution, responds to conserved mammal pregnancy cues (e.g. progesterone), and facilitates species-specific responses. Here we identify 13 miRNA gene families that arose at the origin of placental mammals and were subsequently retained in all descendent lineages. The expression of these miRNAs in response to early pregnancy molecules is regulated in a species-specific manner in endometrial epithelia of species with extreme implantation strategies (i.e. bovine and human). Furthermore, this set of miRNAs preferentially target proteins under positive selective pressure on the ancestral eutherian lineage. Discovery of this core embryo implantation toolkit and specifically adapted proteins helps explain the origin and evolution of implantation in mammals.

Smokefree ticket-Project - referring primary care patients to the German Quitline: Implantation strategies and Progress after 3 years

Smokefree ticket-Project - referring primary care patients to the German Quitline: Implantation strategies and Progress after 3 years

Stereo-electroencephalography (SEEG)-Guided Surgery in Epilepsy With Cingulate Gyrus Involvement: Electrode Implantation Strategies and Postoperative Seizure Outcome.

Surgical treatment of cingulate gyrus epilepsy is associated with good results on seizures despite its rarity and challenging aspects. Invasive EEG monitoring is often mandatory to assess the epileptogenic zone in these patients. To date, only small surgical series have been published, and a consensus about management of these complex cases did not emerge. The authors retrospectively analyzed a large surgical series of patients in whom at least part of the cingulate gyrus was confirmed as included in the epileptogenic zone by means of stereo-electroencephalography and was thus resected. One hundred twenty-seven patients were selected. Stereo-electroencephalography-guided implantation of intracerebral electrodes was performed in the right hemisphere in 62 patients (48.8%) and in the left hemisphere in 44 patients (34.7%), whereas 21 patients (16.5%) underwent bilateral implantations. The median number of implanted electrodes per patient was 13 (interquartile range 12-15). The median number of electrodes targeting the cingulate gyrus was 4 (interquartile range 3-5). The cingulate gyrus was explored bilaterally in 19 patients (15%). Complication rate was 0.8%. A favorable outcome (Engel class I) was obtained in 54.3% of patients, with a median follow-up of 60 months. The chance to obtain seizure freedom increased in cases in whom histologic diagnosis was type-IIb focal cortical dysplasia or tumor (mostly ganglioglioma or dysembryoplastic neuroepithelial tumor) and with male gender. Higher seizure frequency predicted better outcome with a trend toward significance. Our findings suggest that stereo-electroencephalography is a safe and effective methodology in achieving seizure freedom in complex cases of epilepsy with cingulate gyrus involvement.

Spinal Cord Stimulation for Failed Back Surgery Syndrome: to Trial or Not to Trial?

Spinal cord stimulation (SCS) is a recommended therapy to treat failed back surgery syndrome (FBSS). A trial period is practiced to enhance patient selection. However, its fundamental evidence is limited, especially concerning long-term benefit and therapy safety. We compared the long-term (5.3 ± 4.0 years) clinical outcome and therapy safety of a trialed and nontrialed implantation strategy, including multidimensional variables and pain intensity fluctuations over time. A multicenter cohort analysis was performed in 2 comparable groups of FBSS patients. Regarding eligibility, patients had to be treated with SCS for at least 3 months. While the Trial group comprised patients who underwent an SCS implantation after a successful trial, the No-Trial group encompassed patients who underwent complete implantation within 1 session. The primary outcome measures were pain intensity scores and complications. The Trial and No-Trial groups consisted of 194 and 376 patients (N = 570), respectively. A statistically but not clinically significant difference in pain intensity (P = .003; effect = 0.506 (.172–.839)) was found in favor of the Trial group. No interaction between a time dependency effect and pain intensity was noted. Whereas trialed SCS patients were more likely to cease opioid usage (P = .003; OR = .509 (.326–.792)), patients in the No-Trial group endured fewer infections (P = .006; proportion difference = .43 (.007–.083)). Although the clinical relevance of our findings should be proven in future studies, this long-term real-world data study indicates that patient-centered assessments on whether an SCS trial should be performed have to be investigated. According to the current ambiguous evidence, SCS trials should be considered on a case-by-case basis. PerspectiveThe currently available comparative evidence, together with our results, remains ambiguous on which SCS implantation strategy might be deemed superior. An SCS trial should be considered on a case-by-case basis, for which further investigation of its clinical utility in certain patient populations or character traits is warranted.