Implantation Procedure Research Articles

Device dislodgement and embolization associated with a new leadless pacemaker.

Currently, there are two approved single chamber leadless pacemakers (LP) in the United States (US), Micra VR™; approved since 2016 and AVEIR VR™; approved in 2022. A potential complication of LPs is dislodgement and/or embolization (D/E) during or after implant. According to the IDE trials, there appears to be a significant difference in D/E rates between the two LPs that have different fixation mechanisms; Micra uses nitinol tines, while AVEIR uses an active screw helix. The aim of this study was to determine if the AVEIR VR LP has continued to exhibit D/E in the United States since it was approved by the Food and Drug Administration (FDA) in April 2022. The FDA Manufacturer and User Facility Device Experience (MAUDE) database was searched for US D/E reports communicated by the manufacturers of both LP devices. For AVEIR VR we reviewed reports from approval till December 2023, and for Micra VR we looked at reports from approval to April 2024. Excluded were reports based on information indirectly obtained from registries, journals, social media, or volunteers. Total number of US implants was acquired from the manufacturers' product performance reports. During a period of 21 months, 5990 AVEIR VR implants had been registered in the United States, of which 53 (0.88%) encountered D/E both during and after the procedure. More D/E (32; 60.4%) occurred during the implantation procedure, with device release problems being the most prominent procedural issue involved with these events. Within a 8-year period, 72 237 Micra VR implants have been registered in the United States, of which 211 (0.29%) showed D/E. The rate of D/E since the US approval of both devices was significantly higher for AVEIR VR compared to Micra VR (0.88% vs 0.29%; p < .0001). AVEIR VR implants may be complicated by dislodgement with or without embolization. Currently, the estimated incidence is about 0.9%, which is significantly higher than Micra VR. Fixation issues and separation problems of the device from the delivery catheter appear to be responsible for most of these D/E events.

Real-world evidence of implanting leadless pacemakers after transcatheter aortic valve implantation procedures

Abstract Background Conduction disturbances can be a complication of Transcatheter Aortic Valve Implantation (TAVI) procedures, for which transvenous pacemakers (TVPs) are recommended. Leadless pacemakers (LPs) are a safe alternative to TVPs in a pacemaker-indicated population, but little is known about their use for TAVI-related conduction disturbances. Purpose To examine rates of pacemaker implantation post-TAVI, compare complications, all-cause mortality, and ventricular pacing rates in LP vs. TVP patients, and assess pacemaker deactivations/upgrades in LP patients. Methods Data from Optum’s de-identified Clinformatics Data Mart Database linked to a device registry between 2016 and 2021 were used to identify patients with TAVI procedures that are subsequently implanted with an LP or a TVP. Claims data were used to assess complications and all-cause mortality; device-reported parameters were used to calculate VP rates and deactivations. Complication rates, all-cause mortality, ventricular pacing rates, and device deactivations were calculated for patients with a pacemaker implant between 7 days before and 90 days after TAVI. Chronic complication rates, defined as complications with the potential to occur outside the acute peri- or post-procedural period, were assessed at 1 year. Regressions were used to compare complications and all-cause mortality, adjusting for patient characteristics. Results In a cohort of 18,073 patients with a TAVI procedure, 11.7% were implanted with a pacemaker at 1 year post-TAVI; 76.7% of implants occurred within 7 days. LPs comprised 7.2% of the total pacemaker implants observed. Of those LPs in the registry, around 25% have VDD capability. LP patients were older (avg. 84 LP, 82 TVP, p=0.02) and were more likely to have atrial fibrillation, end-stage or chronic kidney disease, and ventricular arrhythmias. Of patients implanted with a pacemaker within 90 days post-TAVI (LP N=122, TVP N=1,779), there were no differences in 30-day complication rates (12.3% LP, 15.6% TVP, unadj. p=0.33, adj. p=0.27). LP had fewer chronic complications than TVP (0.8% LP, 9.4% TVP, unadj. p=0.02, adj p=0.02) though the sample size was small. LP patients had higher unadjusted 30-day all-cause mortality (4.1% LP, 1.0% TVP, unadj. p=0.01, adj. p=0.06), reflecting the higher acuity of LP patients. At both 30 days and 1 year post-implant, most patients (85.3% LP, 72.7% TVP) continued to receive pacing support (ventricular pacing &amp;gt;10%). TVP patients were more likely than LP patients to be pacing dependent (ventricular pacing ≥90%) at both 30 days (53.8% vs. 29.4%) and 1 year (44.7% vs. 35.7%) post-implant. There were no observed deactivations/upgrades in LP patients at 1 year. Conclusion LPs, when used concomitantly with TAVI procedures, show similar acute and lower chronic complication rates compared to patients treated with TVPs implanted with TAVI. Most patients who received a pacemaker post-TAVI continue to receive pacing support.Acute and Chronic complicationsVentricular pacing

Comparative study of the surface and endocavitary signals of cardiac pacing system analyzers with respect to the conventional polygraphy systems signals during implantation of conduction system pacing

Abstract Introduction and objectives Left bundle branch area pacing (LBBAP), is a novel modality of physiologic pacing that requires an adequate assessment of the endocardium as well as the body-surface electrocardiographic signals for a successful pacing-lead implantation. We aimed to assess if LBBAP criteria(1), specifically left ventricular septal pacing (LVSP) and left bundle branch pacing (LBBP) criteria, can be satisfactory measured using the signals resulting from different cardiac pacing analyzers (PSAs) by comparing them to the ‘conventional’ signals obtained from multichannel polygraph systems (MPSs) during the implantation procedure. Methods Comparative observational, prospective, multicenter study of consecutive patients who underwent a LBBAP strategy as first intention. LBBP was defined in the presence of a paced QRS with right bundle branch morphology in V1 (initial r wave in lead V1) and at least one of the following criteria: 1. V6-R-Wave Peak Time (RWPT) &amp;lt; 80 ms. 2. V1–V6 interpeak interval &amp;gt; 33 ms. 3. QRS transition from non-selective left bundle branch pacing to selective left bundle branch pacing or NS-LBBP to left ventricular septal pacing during pacing threshold. 4. Sudden increase of V6-RWPT &amp;gt; 15 ms because of reducing pacing output. 5. Left bundle potential-V6RWPT = stim-V6RWPT (±10 ms). For patients without initial r wave in V1, LBBP was considered in the presence of QRS transition during pacing. LVSP was defined by a paced QRS showing a typical terminal R-wave in V1, anatomical position of the lead in the left ventricular septum documented by fluoroscopy and not fulfilling the additional criteria previously described for LBBP. Results 63 patients were included. The basal characteristics of the patients are shown in Figure I. No significant differences (p&amp;lt;0.96) were observed in the basal QRS between the MPSs (129±29ms) and the PSAs (129±28ms). Initial "W" morphology in V1 during initial pacing was obtained in 90% of patients, without differences between both measurement systems. There were no significant differences between the MPSs and the PSAs in the paced QRS in V1 (140±10ms vs 141±12ms, p&amp;lt;0.746) nor in V6 (127.4±13ms vs 128.2±14.6ms, p&amp;lt;0.96). The measurement of the R wave peak time (RWPT) in V6 was 78.3±15ms vs 77±14 ms (p&amp;lt;0.72), and the V1-V6 inter-peak was 41.1±16ms in the MPSs vs 39±16 ms the PSAs (p&amp;lt;0.6), respectively, the Pearson correlation coefficients for these last two measurements being 0.91 (p &amp;lt;0.0001) and 0.91 (p &amp;lt;0.0001) (Figure II). Finally, according to electrocardiographic criteria measured by the MPSs, LBBP was achieved in 69% of patients, accomplishing 31% of the patients LVSP criteria, being the same proportions observed when PSAs measures where applied. Conclusions The signals resulting from the different PSAs can be useful to assess septal as well as LBBP criteria as an alternative to the ‘conventional’ signals obtained from MPSs.

Procedure-related radiation and contrast use during TAVI procedures with balloon-expandable versus self-expanding devices

Abstract Background Transcatheter aortic valve implantation (TAVI) procedures show some fundamental differences, depending on the use of balloon-expandable (BEV) or self-expanding (SEV) devices. We aimed to assess, how it translates into contrast use and radiation exposure. Methods From five high volume European centers consecutive patients were included, who underwent transfemoral TAVI procedure. Patient- and procedural characteristics were recorded and compared in relation to the used TAVI device. Results In total 3131 patients were included. 53% were male and the mean age was 80±9 years. 1273 (41%) patients were treated with BEV, while 1858 (59%) with a SEV system. Patients, receiving SEV were older (81±9 vs 79±9 years, respectively; p&amp;lt;0.01) and were more often females (57% vs 33%, respectively; p&amp;lt;0.01). There was also a trend for less peripheral artery disease (14% vs 17%, respectively; p=0.06). Overall total radiation time was 15±9 min., that was markedly shorter for BEV than for SEV (13±8 vs. 17±10 min., respectively; p&amp;lt;0.01). On average 130±65 mL contrast media was used, that was less for BEV than for SEV (104±52 vs. 148±67 mL, respectively; p&amp;lt;0.01) In terms of contrast use, retrievable- and non-retrievable SEVs were comparable (148±71 vs. 146±63 mL, respectively; p=0.41), but both markedly higher, than for BEVs (p&amp;lt;0.01 for both). Non-retrievable SEVs required less radiation (14±7 vs. 18±10 mins, respectively; p&amp;lt;0.01), but still markedly more than BEVs (p&amp;lt;0.01). Conclusion TAVI procedures with BEV require shorter radiation exposure for the team and markedly less contrast, than with SEV. This might be reasonable to consider during patient-tailored procedure planning.Radiation and contrast usage during TAVI

Early echocardiographic changes and reverse remodeling after transcatheter aortic valve implantation

Abstract Introduction Our hospital is a tertiary centre performing more than 500 transcatheter aortic valve implantation (TAVI) procedures annually. In this study we present early echocardiographic changes post-TAVI. Methods Clinical data collection and comprehensive echocardiography was performed the day before and 3.5±1.6 months after TAVI. Data analysis compared pre- and post-TAVI evaluations. Results A total of 101 patients were analyzed. Mean age was 80.1±6.8 years and 40% were female. TAVI was performed transfemorally in all patients, with 83% receiving a balloon expandable valve. NYHA class improved from 2.5±0.6 to 1.4±0.5 after TAVI (p&amp;lt;0.001) Echocardiographic parameters are summarized in Table. Global longitudinal strain (GLS) improved from -17±4% pre-TAVI to -18±4% post-TAVI (p&amp;lt;0.001), with no notable change in LVEF. A significant reverse remodeling with ≥10% reduction in left ventricular mass index (LVMi) was observed in 52% of patients following TAVI (from 124±32 to 110±29 g/m2, p&amp;lt;0.001) (Figure). Predictors of LVMi reduction were pre-TAVI LVMi and absence of comorbid hypertension (OR=1.02, 95% CI=1-1.03, p=0.03 and OR=0.31, 95% CI=0.11-0.84, p=0.02 respectively). There was no significant improvement in diastolic function, including left atrial strain. Conclusions Early post-TAVI assessments showed significant reverse remodelling with improvements in GLS and LVMi after TAVI. Predictors of LVMi reduction post-TAVI were absence of comorbid hypertension and higher baseline LVMi. There was no notable changes in diastolic function.

The evolution of endothelial dysfunction according to the length of the implanted stent on the background of nebivolol therapy

Abstract Introduction The development of atherosclerosis is the driving cause for arterial interventions using coronary stents. Long-stent implantation can increase the vascular injury thereby contributing to the progression of endothelial dysfunction (ED) by the degradation and reduction bioavailability of the nitric oxide (NO) - thus increasing the risk of major cardiovascular events. Purpose Evaluation the evolution of endothelial dysfunction biomarker depending on the length of the stent implanted on the background of nebivolol therapy. Methods The study included 100 patients with stable angina pectoris II–III functional class (age 59.72±0.59 years) undergoing PCI with stent implantation who started the treatment with nebivolol 5mg per day tangent to the conventional treatment and were exposed to PCI with stent implantation, depending on the stent’s length they were divided in three groups: I group - 14 patients with implanted stent’s length ≤15 mm, II group - 57 subjects with implanted stent’s length =15-30 mm and the III group -29 cases where the implanted stent’s length was ≥30 mm. In all the groups was appreciated in blood the endothelial dysfunction’s marker - NO. This marker was assessed preprocedural, postprocedural (after 24 hours) and at intervals of one month, 3,6,12 months after coronary angioplasty, the NO level being compared between these groups and the reference pattern consisting of 20 healthy people. Results The circulating level of nitric oxide determined in I group -61,28±6,92 μM/L and in the II group -56.6±3.03 μM/L and the III group52.39±3.35 was compromised at the preprocedural stage versus the reference pattern - 78.67±2.72 μM/L. During the post- PCI period (first 24 hours), the biomarker level’s was reduced in I group -52.35±1.66 μM/ L, II group -53.74±2.77 μM/L and III group - 52.98±2.91 μM/L. After one month after the intervention on the backroung of the treatment with nebivolol, was recorded a gaing of the NO value in I group - 64.97±5.35 μM/L, II group -63.15±3.99 μM /L and the III group-59.38±4.46 μM/L. The NO serum concentration during the period 3 and 6 months continued to increase in all groups vs the reference pattern. At the 12-month period, the NO level remained high in all the studied groups versus the baseline: I group 99.2±1.1 μM / L (p&amp;gt;0.05), II group-97.96±2.2 μM/L (p&amp;lt;0.001) and the III group -97.65±1.9 μM/L (p&amp;lt;0.001). Conclusion The stent’s length = 15-30 mm and ≥30 mm reveals the presence of an expanded atherosclerotic process, the substrate of which is constituted by the endothelial dysfunction, this being confirmed by the low preprocedural level of NO. The stent implantation procedure induced the accentuation of endothelial dysfunction, and the 12-month nebivolol treatment favored the increase of NO serum concentraon in all groups by 24.9% vs the reference pattern and by 73.3% vs baseline.

Atrioventricular block as a common problem in elderly patients with coronary artery disease: clinical observation

Complete atrioventricular block is a dangerous complication in elderly patients with coronary artery disease that requires surgical treatment. Treatment of elderly patients with coronary artery disease and atrioventricular block is a debatable problem, and at the moment, there are no clear recommendations regarding the sequence of surgical interventions in this age group. In our opinion, in some cases it is advisable to perform epicardial lead placement during revascularization, because the risk of complications during the implantation procedure increases on the background of dual antiplatelet therapy, which is required after coronary artery bypass grafting. In addition, this approach provides a significant socio-economic effect, saving a patient from re-hospitalization and intervention for conduction disorders. This article presents a clinical observation with a step-by-step algorithm of actions in multivessel coronary artery disease with complete symptomatic atrioventricular block.

Dextrocardia with complete atrioventricular block—the right clinical approach to pace a heart on the right hemithorax: a case report

BackgroundA heart positioned on the right side of the thorax can be more a complex situation than it seems, also the potentially associated congenital cardiopathies are variable. In this regard, patients with dextrocardia presenting with complete atrioventricular block require a thorough anatomical investigation to map the veno-arterial system and potential cardiovascular defects before proceeding with a permanent pacing procedure.Case presentationA 73-year-old Caucasian woman with no significant medical history presented with syncope. Physical examination showed regular heart sounds with an average heart rate of 35–40 beats per minute and no other relevant physical findings. Chest X-rays revealed a heart positioned in the right hemithorax. A standard electrocardiogram revealed complete atrioventricular block with junctional escape rhythm at nearly 35–40 beats per minute. A transthoracic echocardiogram showed a mirror image dextrocardia without any other remarkable abnormalities. Venogram performed using the left peripheral cephalic vein showed normal venous return into the right atrium positioned on the left side. Surgical intervention consisted of permanent dual chamber pacemaker implantation using the left subclavian vein. Discussion is provided based on the relevant medical literature outlining different potential scenarios with associated cardiac and major vessels abnormalities.ConclusionThis case highlights an atypical presentation of atrioventricular block in a patient with dextrocardia and situs inversus, for whom a successful dual-pacemaker implantation procedure was performed.

Outcomes of Radiation Dose Reduction Protocol in Electrophysiologic and Cardiac Device Procedures

Background: Exposure to radiation has been demonstrated to be associated with adverse short- and long-term health outcomes. Objective: To presented outcomes before and after the implementation of a radiation dose reduction protocol in electrophysiologic (EP) and cardiac device procedures. Materials and Methods: The present study was a retrospective comparative study, conducted at Chiang Mai University Hospital in Thailand using 2017 and 2019 data, including all patients who underwent EP and cardiac implantable electronic device (CIED) procedures. Exclusion criteria involved patients with incomplete radiation dose records. The authors compared fluoroscopic time, radiation exposure, and complication rates before and after the protocol. Results: Among the 458 cases, with 214 Eps and 244 devices, the mean age was 58 years. For device implantation procedures, there was no significant change in fluoroscopic time as median (P₂₅, P₇₅) before and after protocol implementation were 3.1 (0.4, 5.8) versus 4.4 (1.2,7.6) minutes, respectively (p=0.117). However, there was a decreasing trend in dose area product (DAP) at 242.0 (119.2, 766.0) versus 197.9 (71.5, 494.5) cGy.cm² (p=0.073). The reduction in DAP was more pronounced in cardiac resynchronization therapy (CRT) implantation when comparing 2017 to 2019 were 1,933.6 (1,039.4, 7,683.8) versus 1,074.6 (427.2, 2,890.7) cGy.cm² (p=0.020). In EP procedures, fluoroscopic time significantly decreased from 8.1 (3.0, 14.3) minutes in 2017 to 1.0 (0.0, 3.6) minute in 2019 (p&lt;0.001), accompanied by a significant reduction in exposure dose of 45.0 (10.8, 153.3) versus 1.7 (0.0, 31.6) mGy (p&lt;0.001) and DAP of 1,022.9 (247.2, 2,660.3) versus 38.5 (0.0, 566.9) cGy.cm² (p&lt;0.001). There was no difference in the complication rate between the two periods. Conclusion: The implementation of the radiation dose reduction protocol resulted in a significant decrease in radiation exposure during EP procedures and showed a trend towards reduction in CIED procedures.

Real-Time Ambulatory ECG Does Not Expedite Care.

Ambulatory ECG (AECG) monitoring is pivotal to the diagnosis of arrhythmias and can be performed with near "real-time" notification of abnormalities. There are limited data on the relative benefit of real-time monitoring compared with traditional Holter monitoring. This is a retrospective observational analysis of University of Utah Health patients who underwent ambulatory ECG studies from 2010 to 2022. The study cohort was stratified by patients with an ambulatory ECG that provides real-time event notification (non-Holter) versus those who do not (Holter). The outcomes were cardiac implantable electronic device procedure, ablation procedure, emergency department/hospitalization visit, and initiation of anticoagulation out to 6 months. We identified 20 259 patients, 16 650 with non-Holter studies and 3609 with Holter studies. Holter patients were younger (mean 52 versus 55, P<0.001), more often women (60.2% versus 57%, P<0.001), and had lower mean CHADS2-VA2Sc scores (1.7 versus 2.1, P<0.001). The median time to ablation procedure was 74 versus 72 (P=0.5), for Holter versus non-Holter, respectively. Median days to new cardiac implantable electronic device implantation was 54 days versus 52 (P=0.6); initiation of anticoagulation among patients not already treated was 42 versus 31 days (P=0.03). Time to first emergency department visit or hospitalization was 63 versus 57 (P=0.6). In multivariable models, there were no significant differences in time to intervention between Holter and non-Holter for each outcome. Real-time monitoring demonstrates mixed results in terms of reducing time to intervention, with the significant benefit limited to oral anticoagulation initiation. It is time to revisit clinical scenarios where real-time ambulatory monitoring may not improve health care efficiency.

Pseudomonas monteilii bacteremia and sepsis following insertable cardiac monitor implantation: a case report

BackgroundInsertable cardiac monitor implantation is a simple and safe procedure commonly performed in patients with embolic stroke with undetermined source. Routine periprocedural antibiotic use is not recommended, because infection rate is very low, although some local infection or gram-positive bacteremia have been reported. We report a case of Pseudomonas monteilii sepsis immediately after insertable cardiac monitor implantation.Case presentationA 55-year-old Korean male with embolic stroke of undetermined source presented with gram-negative sepsis immediately after implantable cardiac monitor implantation as a first reported complication after the procedure. Pseudomonas monteilii was identified in the blood culture, and no other infection source was seen. He was treated with intravenous antibiotics without removing the device.ConclusionsPrompt diagnosis and adequate management is required in such a patient with sepsis post-insertable cardiac monitor implantation procedure. It can be managed with adequate antibiotic treatment without device removal if there is no sign of inflammation at the insertion site. Further reports or studies should be investigated to reinforce this finding.Learning objectivesThe infection rate after insertable cardiac monitor insertion is extremely low; however, sepsis may occur without pocket infections. Physicians should be aware of signs of systemic infection, particularly when the procedure is performed outside the catheterization room. Sepsis after insertable cardiac monitor implantation can be managed with adequate antibiotic treatment without device removal if there is no sign of inflammation at the insertion site.

Expert opinion on candidacy for bone conduction hearing implants Osia System and Baha Connect System.

&lt;b&gt;Introduction:&lt;/b&gt; Bone conduction hearing implants (BCHI) are a widely used rehabilitation solution for patients with conductive hearing loss (CHL), mixed hearing loss (MHL), or single-sided deafness (SSD).&lt;b&gt;Aim:&lt;/b&gt; This expert review presents candidacy criteria considerations when choosing between active transcutaneous bone-conduction hearing devices (Osia&lt;sup&gt;&lt;/sup&gt; System) and passive percutaneous bone-conduction hearing devices (Baha&lt;sup&gt;&lt;/sup&gt; Connect System) to help streamline the decision-making process in those contexts where economics have a major impact on professionals' and patients' choice.&lt;b&gt;Methods:&lt;/b&gt; Eight experts participated in two online surveys and two virtual meetings to discuss real-world clinical experience to highlight treatment approaches and factors considered when counseling the patients and selecting an optimal BCHI solution. Key considerations for decision-making were recorded following consensus from all experts.&lt;b&gt;Conclusions:&lt;/b&gt; Aspects in decision making include the requirement to use local &lt;i&gt;versus&lt;/i&gt; general anesthesia for the implantation procedure, bone thickness, considerations for future magnetic resonance imaging (MRI) procedures, and patient preference. Increased risk of skin infections, requirements for cleaning and managing the implant site, particularly for those with limited dexterity, as well as esthetic concerns could make the Baha&lt;sup&gt;&lt;/sup&gt; Connect System unsuitable for some patients. In these cases, the Osia&lt;sup&gt;&lt;/sup&gt; System may provide clear advantages, particularly in patients for whom good hearing performance is a priority, and this would need to be discussed individually with the patient in a multidisciplinary setting. Conversely, for patients requiring minimally invasive surgery, who have contraindications for general anesthesia or require frequent head MRI scans in the future, the Baha Connect System may be more suitable.

Refractive outcomes following simultaneous silicone oil removal and ciliary sulcus intraocular lens implantation.

This study aimed to assess the refractive outcomes following the combined intervention of silicon oil (SO) removal and ciliary sulcus intraocular lens (IOL) implantation in aphakic eyes after phacovitrectomy. A retrospective examination of medical records from patients who underwent a combined procedure of SO removal and ciliary sulcus IOL implantation from 2019 to 2022 was performed. The primary outcomes of interest included uncorrected distance visual acuity (UDVA), predictive error (PE) and mean absolute predictive error (MAE). Subgroup analyses were performed to compare outcomes between patients with and without intraoperative posterior capsulotomy. The cohort comprised 40 eyes from 40 patients, with a mean duration of SO tamponade of 5.17 ± 1.48 months. A significant improvement in UDVA was observed from 1.58 ± 0.31 logMAR to 0.99 ± 0.31 logMAR one month postoperatively (P < 0.01). The PE was -0.73 ± 0.86 diopters (D), and the MAE was 0.90 ± 0.67 D, with 37.50% and 57.50% of cases achieving PE within ±0.5 D and ±1.0 D, respectively. No significant differences in UDVA, PE, or MAE were found between the capsulotomy and non-capsulotomy subgroups (all P > 0.05). However, a lower proportion of eyes in the capsulotomy group achieved PE within ±1.0 D compared to the non-capsulotomy group one month postoperatively (38.90% vs. 72.70%, P = 0.03). The combined procedure of SO removal and sulcus IOL implantation resulted in a mild myopic shift in postoperative refraction. Intraoperative posterior capsulotomy seems to increase the lability of postoperative refractive outcomes.

A Woven EndoBridge dislodging from an aneurysm 12 days after the implantation procedure: illustrative case.

The Woven EndoBridge (WEB) is an effective embolization device. A few cases of WEB migration have been reported as adverse events, and most occurred during the procedure. A case of internal carotid artery (ICA) occlusion due to a trapped WEB, which occurred 12 days after the implantation procedure, is reported. A woman in her 70s was referred for an enlarged left ICA aneurysm during follow-up. A WEB SL 5 × 3 was chosen as the embolic device, and the implantation procedure was completed uneventfully. The patient's postoperative course was good, and she was discharged from the hospital. However, 12 days later, she was brought to the authors' hospital because the WEB device was trapped and occluded in the left ICA. The trapped WEB could not be retrieved using a gooseneck snare or stent retriever, but suction from a Sofia catheter released the trapped device, allowing it to be repositioned within the aneurysm. Most cases of WEB migration occur during surgery. In the present case, migration occurred 12 days after surgery, and to the best of the authors' knowledge, no similar cases have been reported. It is important to keep in mind that there are cases similar to the current case. https://thejns.org/doi/10.3171/CASE24278.

Visual and patient reported outcomes provided by a refractive multifocal intraocular lens based on continuous transitional focus

PurposeTo analyze the quality of vision of patients implanted bilaterally with the multifocal Precizon Presbyopic intraocular lens (IOL), as well as to evaluate the visual performance provided by the lens.SettingVissum Miranza Alicante.DesignProspective multicenter study.Methods56 patients (mean age 65.0 ± 8.7 years old) underwent bilateral implantation with multifocal Precizon Presbyopic IOL. The quality of vision was assessed by a quality of vision questionnaire at 6 months after the implantation procedure, a complete eye examination was also performed including visual and refractive measurements, defocus curve and contrast sensitivity assessment. Visual and refractive variables were compared in preoperative, 3-month postoperative and 6-month postoperative visits by Wilcoxon test.ResultsThe quality of vision analysis showed the absence of severe glare and severe haloes in all evaluated patients. Likewise, non-symptoms of glare, haloes and starbursts were seen in 75%, 68%, and 55% of subjects, respectively. Efficacy and safety index was 1.26 and 1.42, respectively. The 6-month postoperative binocular uncorrected distance visual acuity and near uncorrected visual acuity were 0.00 ± 0.09 and 0.20 ± 0.13 logMAR, respectively. Mean spherical equivalent was 0.29 ± 0.45 D.ConclusionsThe Precizon Presbyopic NVA IOL (OPHTEC BV) provides a suitable quality of vision with a low rate of disturbance photic phenomena induction, as well as an excellent visual performance at main distances of sight accomplishing the visual demands of the majority of patients.

Congenital heart diseases

During the last decades, the prognosis for patients with congenital heart disease (CHD) has gone through a tremendous development due to improvement in diagnostic tools, treatment, and follow-up. This has resulted in a demographic change of the population with CHD so that the number of adults exceeds that of paediatric patients. The improved survival has led to new challenges including re-interventions addressing residual lesions as well as long-term complications such as arrhythmia and heart failure. This has resulted in the development of novel catheter-based interventions e.g. percutaneous valve implantation, pulsed-field ablation, and lymphatic procedures as summarised in this review. Despite this, further developments are needed since morbidity and mortality are still significantly increased in patients with CHD compared to the background population.

Stochastic Nanoroughness Inhibits and Reverses Glial Scarring In Vitro and In Vivo via a Mechanobiology Paradigm Involving Piezo‐1

AbstractPhysical insult to the central nervous system (CNS) such as during electrode insertion leads to reactive astrogliosis which in turn contributes to glial scarring (GS). To date, reducing GS in these settings has focused on pharmacological agents and variations in electrode material composition or implantation procedures, and the role of electrode surface topography has remained unexplored. Since proteoglycans, a major component of GS tissue, possesses very well‐defined (nano) topography, a role for stochastic nanoroughness in glial scar formation is theorized. Using an in vitro system, we provide proof of concept that on substrates possessing stochastic nanoroughness corresponding to that of healthy astrocytes, glial scar formation is significantly inhibited, and more importantly, can be even reversed, and it involves signaling via the stretch‐activated cation channel Piezo‐1. In vivo studies reveal an absence of astrocytes aggregation along the electrode track of chronically implanted electrodes modified with stochastic surface nanoroughness, compared to non‐modified electrodes, while signal detection within the superior colliculus remains unaffected. These findings shedlight on the crucial role of stochastic biophysical cues in modulating GS formation; and offer a promising non‐chemical approach for engineering neural biomaterials interface for the CNS.

The modified Caldwell-Luc approach for treating odontogenic maxillary sinusitis without need for functional endoscopic sinus surgery (FESS). A retrospective study

BackgroundOdontogenic maxillary sinusitis is a common inflammatory condition resulting from the violation of the Schneiderian membrane by conditions arising from the dentoalveolar unit, which includes teeth, their supporting structures, and adjacent tissues. This study aims to evaluate a modified surgical approach for treating this condition. PurposeThe purpose of this study is to measure the frequency of re-treatment of maxillary sinusitis of odontogenic origin following treatment with a modified Caldwell-Luc approach, which involves accessing the maxillary sinus through the canine fossa without creating a counter-opening in the inferior nasal meatus. Study DesignThis retrospective cohort study included 82 cases (83 sinuses) with odontogenic sinusitis treated surgically with the modified Caldwell-Luc technique at the Department of Oral and Maxillofacial Surgery, Poriya Medical Center, between 2014 and 2021. Patients with non-odontogenic sinusitis were excluded. Predictor VariablesAnatomic findings defined as the presence or absence of ostiomeatal complex abnormalities and oroantral communication, as identified through clinical examination and CT imaging. Main Outcome VariablesThe need for retreatment, defined as the requirement for functional endoscopic sinus surgery (FESS) due to persistent signs and symptoms of maxillary sinusitis after the modified Caldwell-Luc procedure, including facial pain/pressure, nasal congestion, purulent nasal discharge, or radiographic evidence of persistent sinus opacification on CT scan, lasting more than 4 weeks despite appropriate medical management. CovariatesCovariates included demographic data (age, sex [male/female as identified at birth]), smoking status, etiologies of odontogenic sinusitis, and surgical conditions. AnalysesDescriptive statistics, Cox proportional hazards regression was used to compute hazard ratios. Kaplan-Meier survival analysis was performed to estimate the probability of remaining FESS-free over time. The level of statistical significance was set at p < 0.05. ResultsThe sample was composed of 82 patients (83 sinuses) with a mean age of 52.3 years (SD 13.5), and 47 (56.6%) were male. Dental implantation and sinus augmentation procedures were the most common etiologies of odontogenic sinusitis (50.6%). The median follow-up time was 6.03 months (IQR: 2.57 - 10.93 months). The incidence rate of FESS requirement was 2.64 per 100 person-months of follow-up. The FESS-free frequency was 89.2% (95% CI: 80.4% - 94.4%). The Kaplan-Meier analysis estimated the probability of remaining FESS-free at 12 months to be 89.1% (95% CI: 79.8% - 94.4%). Patients with OMC abnormalities had a hazard ratio of 2.25 (95% CI: 0.47-10.84, p = 0.31) for requiring FESS, while those with OAC had a hazard ratio of 1.85 (95% CI: 0.46-7.39, p = 0.38). Conclusions and RelevanceThe modified Caldwell-Luc procedure was effective in treating the majority of odontogenic sinusitis cases. FESS may be necessary in a small percentage of cases with persistent symptoms. Further research is needed to identify predictors for FESS requirement. Of note, we recommend that oral and maxillofacial surgery surgeons review sinusitis cases with a FESS surgeon before performing the modified Caldwell-Luc procedure creating the opportunity for simultaneous or closely timed procedures when necessary

Mechanical dyssynchrony in patients with chronic heart failure and left bundle branch block

Background. The main problem in patient selection for cardiac resynchronization therapy (CRT) is the lack of unified approaches to the definition of mechanical dyssynchrony (MD) and selection criteria, particularly, in patients with left bundle branch block (LBBB).Aim: To study mechanical dyssynchrony indices and three-dimensional Echo (3DE) criteria of global and local contractility function in patients with chronic heart failure (CHF) and LBBB during different types of isolated left ventricle (LV) pacing.Methodology and Research Methods. The experimental intraoperative study involved 88 points obtained from 12 patients with CRT class IA indications and LBBB. During isolated LV pacing as part of CRT implantation procedure endocardial and epicardial pacing were obtained. Transesophageal Echo (TEE) cineloops recording and paced QRS complex morphology registrations by means of LabSystem Pro Electrophysiological Recording System (Bard Electrophysiology, USA) were performed during each stimulation episode. Philips Qlab 10 software was used for TEE data analysis.Results. The global (3D EF, 23.8 [22; 28.4], GLS, –5.33% [10.90%; –15.4%]) and local contractility (ExсAvg 3.5 [2.1; 5.6]) criteria and dyssyncrony indices (SDI-16, 14.9 [8.9; 23.1]) showed severe systolic dysfunction and intraventricular dyssynchrony – typical signs in this patient group, and differed significantly (3D EF, p = 0.003; GLS, p = 0.004; ExcAvg, p &lt; 0.001; Tmsv-6 SD, р = 0.03) depending on the stimulation method and site. A moderate direct correlation between SDI-16 and the QRS duration (common electical dyssynchrony criterium) and inverse correlation with ExcAvg and 3D LVEF also describes LV response.

Open Surgical Implantation of Lumbosacral Dorsal Root Ganglion Stimulators for Chronic Pain: Analysis of Patient Outcomes and Operative Technique

ObjectiveDorsal root ganglion (DRG) stimulator leads were designed to be placed percutaneously, yet open surgical placement via laminectomy is an option. We present the largest series to date of surgically-placed DRG stimulators and the first series where open surgical implantation was the chosen technique and not a salvage procedure. MethodsA retrospective review of a prospective database of DRG implants identified 17 patients who had open lumbosacral DRG lead placement performed by a single surgeon (NDT) between October 2021 and April 2023. Descriptive statistics, fluoroscopy exposure times, and complications were reported. The window of data collection was 1 month pre-operatively to 12 months post-operatively. Phone interviews were conducted to collect information on pain outcomes and patient satisfaction. ResultsWe identified 17 patients (12 women, 5 men) who had lumbosacral DRG placement. Phone interviews were conducted for 10/17 patients, with mean follow-up of 11.9 months. 53% reduction in mean pain score was achieved (n=10, p<0.001). There were no infections, hematomas, or symptomatic lead migrations. 1/17 experienced a superficial dehiscence and 2/17 had an intra-operative repairable durotomy with no post-operative sequelae. Mean fluoroscopy time per lead was 15.4±9.9s (n=10). ConclusionOpen DRG lead placement via laminotomy/laminectomy is reported as a salvage procedure but may have comparable safety and efficacy profile to percutaneous implantation when utilized as the primary implantation method. Before establishing open DRG as an alternative permanent implantation method, more studies are needed to determine whether such benefits as less migration outweigh the risks of a more invasive implantation procedure.