Consecutive Implantation Research Articles

Evaluation of Surgical Learning Curve Effect on Obstructive Sleep Apnea Outcomes in Upper Airway Stimulation.

An increasing number of facilities offer Upper Airway Stimulation (UAS) with varying levels of experience. The goal was to quantify whether a surgical learning curve exists in operative or sleep outcomes in UAS. International multi-center retrospective review of the ADHERE registry, a prospective international multi-center study collecting UAS outcomes. ADHERE registry centers with at least 20 implants and outcomes data through at least 6-month follow-up were reviewed. Cases were divided into two groups based on implant order (the first 10 or second 10 consecutive implants at a given site). Group differences were assessed using Mann-Whitney U-tests, Chi-squared tests, or Fisher's Exact tests, as appropriate. A Mann-Kendall trend test was used to detect if there was a monotonic trend in operative time. Sleep outcome equivalence between experience groups was assessed using the two one-sided tests approach. Thirteen facilities met inclusion criteria, contributing 260 patients. Complication rates did not significantly differ between groups (P = .808). Operative time exhibited a significant downward trend (P < .001), with the median operative time dropping from 150 minutes for the first 10 implants to 134 minutes for the subsequent 10 implants. The decrease in AHI from baseline to 12-month follow-up was equivalent between the first and second ten (22.8 vs 21.2 events/hour, respectively, P < .001). Similarly, the first and second ten groups had equivalent ESS decreases at 6 months (2.0 vs 2.0, respectively, P < .001). ESS outcomes remained equivalent for those with data through 12-months. Across the centers' first 20 implants, an approximately 11% reduction operative time was identified, however, no learning curve effect was seen for 6-month or 12-month AHI or ESS over the first twenty implants. Ongoing monitoring through the ADHERE registry will help measure the impact of evolving provider and patient specific characteristics as the number of implant centers increases.

Refining Planning for Stereoelectroencephalography: A Prospective Validation of Spatial Priors for Computer-Assisted Planning With Application of Dynamic Learning

Objective: Stereoelectroencephalography (SEEG) is a procedure in which many electrodes are stereotactically implanted within different regions of the brain to estimate the epileptogenic zone in patients with drug-refractory focal epilepsy. Computer-assisted planning (CAP) improves risk scores, gray matter sampling, orthogonal drilling angles to the skull and intracerebral length in a fraction of the time required for manual planning. Due to differences in planning practices, such algorithms may not be generalizable between institutions. We provide a prospective validation of clinically feasible trajectories using “spatial priors” derived from previous implantations and implement a machine learning classifier to adapt to evolving planning practices.Methods: Thirty-two patients underwent consecutive SEEG implantations utilizing computer-assisted planning over 2 years. Implanted electrodes from the first 12 patients (108 electrodes) were used as a training set from which entry and target point spatial priors were generated. CAP was then prospectively performed using the spatial priors in a further test set of 20 patients (210 electrodes). A K-nearest neighbor (K-NN) machine learning classifier was implemented as an adaptive learning method to modify the spatial priors dynamically.Results: All of the 318 prospective computer-assisted planned electrodes were implanted without complication. Spatial priors developed from the training set generated clinically feasible trajectories in 79% of the test set. The remaining 21% required entry or target points outside of the spatial priors. The K-NN classifier was able to dynamically model real-time changes in the spatial priors in order to adapt to the evolving planning requirements.Conclusions: We provide spatial priors for common SEEG trajectories that prospectively integrate clinically feasible trajectory planning practices from previous SEEG implantations. This allows institutional SEEG experience to be incorporated and used to guide future implantations. The deployment of a K-NN classifier may improve the generalisability of the algorithm by dynamically modifying the spatial priors in real-time as further implantations are performed.

RETROSPECTIVE EVALUATION OF SUCCESS OF IMPLANT SUPPORTED PROSTHESIS: EARLY RESULTS

Introduction: The interpretation of clinical results of dental implant supported prosthesis treatment is very crucial to be able to make a comparison between different implant systems and treatment options and furthermore to benefit the experiences of the other clinicians. However, the clinical outcomes of these studies should be reported in an objective way and be independent from the system used and also be prepared in accordance with certain criteria and standards that have been accepted scientifically world-wide for being reliable and describing long-term results.&#x0D; Aim: Three-hundred and eighty-two consecutive NTA implants were performed on ninety-nine patients. The implants used in 2016 and the constructed restorations were retrospectively analyzed. In addition, the effect of the experience of clinician was evaluated related with the success of the implant therapy.&#x0D; Materials and Method: This retrospective study was conducted in the Department of Prosthodontics Süleyman Demirel University. Three-hundred and eighty-two consecutive NTA implants were performed on ninety-nine patients. The implants used in 2016 and the constructed restorations were retrospectively analyzed.&#x0D; Results: The implants were followed for at least 2 years. In total, 239 implants were inserted. It was found in 143 mandibles. Prosthetic restorations were determined to be partial prosthetics (219), single crown (81) and overdenture prosthetics (64). During the evaluation period, 6 implants failed before prosthetic treatment, ten decementations, six retentive screw loosening and five porcelain chipping were detected.&#x0D; Discussion and Conclusions: The early results of our study are consistent with the results of other studies. However, long-term follow-up is required for more accurate assessments.

P1149Subcutaneous implantable cardioverter-defibrillator when Transvenous ICD is not a viable option

Abstract Funding Acknowledgements NO FUNDING OnBehalf RHYTHM DETECT Registry Background The class of recommendation for S-ICD implantation in patients who have inadequate vascular access is I according to AHA-ACC-HRS Guidelines and IIb according to ESC Guidelines. Data are lacking about the use of S-ICD for patients in which a transvenous ICD is not a viable option because of the inability to deploy a transvenous lead. Purpose To describe current practice and to measure outcomes associated with S-ICD use in patients in which a transvenous ICD is not a viable option. Methods 942 consecutive patients underwent S-ICD implantation at 22 Italian centers from 2014 to 2019. We identified 101 (11%) patients who received S-ICD because of the reported impossibility of deploying a transvenous lead. Results 21 patients presented with inadequate vascular access but no previous device in place. One patient had a mechanical prosthesis in tricuspid position. The remaining 79 patients received the S-ICD after removal of a prior system implanted, and venous occlusion was diagnosed after lead extraction, or partially or completely failed lead removal. In 24 of these patients a functional transvenous pacing system was left in place for persisting pacing needs. Patients were 60 ± 15 years old, 85% were male, 77% had ischemic or non-ischemic dilated cardiomyopathy, ejection fraction was 36 ± 13%. At implantation, acute conversion test was performed in 64 patients and shock energy of ≤65J was successful in 62 (96.9%) patients. During a median follow-up of 18 months, 6 patients died for non-device related reasons and 1 patient underwent heart transplantation. One patient underwent device replacement for battery depletion and one patient underwent leadless pacemaker implantation. Minor complications (hematomas not requiring system revision) were reported in 2 patients. Appropriate therapies were delivered in 4 patients and 8 patients experienced inappropriate therapies (in 3 patients due to double counting during pacing); all resolved with device reprogramming. Conclusions: In current clinical practice, a minority of S-ICD patients receive the device because of inadequate vascular access. The profile of these patients is similar to that of the typical ICD population in the context of primary sudden death prevention, but many of them present with pacing indications. Acute and mid-term efficacy of S-ICD seemed high. Few complications occurred during follow-up. Particular attention must be paid to device programming for those patients with concomitant pacing systems, in order to prevent inappropriate therapies.

Safety of tunneled central venous catheters in pediatric hematopoietic stem cell recipients with severe primary immunodeficiency diseases.

Tunneled central venous catheters (TCVCs) provide prolonged intravenous access for pediatric patients with severe primary immunodeficiency disease (PID) undergoing hematopoietic stem cell transplantation (HSCT). However, little is known about the epidemiology and clinical significance of TCVC-related morbidity in this particular patient group. We conducted the retrospective analysis of patients with severe PID who received percutaneous landmark-guided TCVC implantation prior to HSCT. We analyzed 92 consecutive TCVC implantations in 69 patients (median [interquartile range] age 3.0 [0-11] years) with severe combined immune deficiency (n = 39, 42.4%), chronic granulomatous disease (n = 17, 18.4%), and other rare PID syndromes (n = 36, 39.2%). The median length of TCVC observation was 144.1 (85.5-194.6) days with a total of 14,040 catheter days at risk (cdr). The overall rate of adverse events during catheter insertion was 17.4% (n = 16) and 25.0% during catheter dwell period (n = 23, catheter risk [CR] per 1000 cdr = 1.64). The most common complication was TCVC-related infection with an overall prevalence of 9.8% (n = 9, CR = 0.64), followed by late dislocation (n = 6, 6.5%, CR = 0.43), early dislocation (n = 4, 4.3%) and catheter dysfunction (n = 4, 4.3%, CR = 0.28). TCVCs are safe in children with severe PID undergoing HSCT with relatively low rates of TCVC-related infection.

Loop Recorder Implantation on a Telemetry Ward

The implantable loop recorder (ILR) is a valuable tool used in the evaluation of syncope, arrhythmia, and cryptogenic stroke. In the inpatient setting, ILRs are routinely implanted in the electrophysiology (EP) lab despite the low complication rate. The purpose of this study was to evaluate the safety, feasibility, and cost of implanting ILRs at the patient's bedside by both electrophysiologists and advanced practice providers (APPs). This was a single center, retrospective study of consecutive ILR implantations performed from February 2018 to May 2019. We examined 3 groups: implantations in the EP lab by electrophysiologists (EP Lab/MD), implantations at the bedside by electrophysiologists (Floor/MD), and implantations at the bedside by APPs (Floor/APP). Over 15 months, 152 patients underwent ILR implantation: 48 in the EP Lab/MD group, 57 in the Floor/MD group, and 47 in the Floor/APP group. The procedure duration was longer in the Floor/APP group (14.2 ± 5.9 minutes) compared with the EP Lab/MD and Floor/MD groups (6.8 ± 4.3 minutes, 9.1 ± 4.9 minutes, p <0.001). The overall complication rate was low (2.6%) with no differences between the groups (p = 0.83). The calculated costs per implant for the EP Lab/MD group, Floor/MD group, and Floor/APP group were $482.05, $162.82, and $73.08, respectively.

A novel clock-face method for characterizing peridevice leaks after left atrial appendage occlusion.

To propose a novel method for mapping leak location and frequency to a clock-face representation of the left atrial appendage (LAA) ostium. LAA occlusion with the Watchman device (WD) is an established therapy to reduce thromboembolic events in patients with atrial fibrillation (AF) and intolerance to long-term oral anticoagulation. Postimplantation leaks are known sequelae, but leak locations and characteristics are poorly described. We retrospectively reviewed 101 consecutive WD implants from April 2015 to February 2018. Leak locations from 6-week post-implant transesophageal echocardiograms were mapped to a clock-face representation of the LAA ostium: 12:00 as cranial near the limbus, 3:00 as anterior toward the pulmonary artery, 6:00 as caudal near the mitral annulus, and 9:00 as posterior. Patient demographics, LAA dimensions, and procedural characteristics were also collected. Thirty-four patients had ≥1 leak totaling 45 leaks at 6-week follow-up. Baseline patient demographics showed a mean age 77, CHA2 DS2 VASc 4.69, and 64% of patients with permanent AF. No patient had a detectable leak at the time of implant. At 6 weeks, mean leak size was 2.67 ± 0.89 mm with no leak over 5 mm (largest 4.60 mm). Most leaks occurred along the posterior 6:00-12:00 segment (39/45) and the 6:00-9:00 quadrant (16/45). Six-week post-WD implant leaks localize to the posterior LAA ostium. This could result from the elliptical LAA orifice, differential LAA tissue composition, or implantation technique. This study provides a novel method for describing the location of post-implant leaks and serves as the basis for further investigations.

Silastic first metatarsophalangeal joint arthroplasty for the treatment of end-stage hallux rigidus.

Arthroplasty for end-stage hallux rigidus (HR) is controversial. Arthrodesis remains the gold standard for surgical treatment, although is not without its complications, with rates of up to 10% for nonunion, 14% for reoperation and 10% for metatarsalgia. The aim of this study was to analyze the outcome of a double-stemmed silastic implant (Wright-Medical, Memphis, Tennessee, USA) for patients with end-stage HR. We conducted a retrospective review of 108 consecutive implants in 76 patients, between January 2005 and December 2016, with a minimum follow-up of two years. The mean age of the patients at the time of surgery was 61.6 years (42 to 84). There were 104 females and four males. Clinical, radiological, patient reported outcome measures (PROMS) data, a visual analogue score (VAS) for pain, and satisfaction scores were collected. The survivorship at a mean follow-up of 5.3 years (2.1 to 14.1) was 97.2%. The mean Manchester Oxford Foot and Ankle Questionnaire (MOXFQ) scores improved from 78.1 to 11.0, and VAS scores for pain from 7/10 to 1.3/10. The rate of satisfaction was 90.6%. Three implants (2.8%) required revision; one for infection, one-month postoperatively, and two for stem breakage at 10.4 and 13.3 years postoperatively. There was a 1.9% reoperation rate other than revision, 23.1% of patients developed a minor complication, and 21.1% of patients had non-progressive and asymptomatic cysts on radiological review. We report a 97.2% survivorship at a mean follow-up of 5.3 years with this implant. We did not find progressive osteolysis, as has been previously reported. These results suggest that this double-stemmed silastic implant provides a predictable and reliable alternative with comparable outcomes to arthrodesis for the treatment of end-stage HR. Cite this article: Bone Joint J 2020;102-B(2):220-226.

Optimization of a GnRHa treatment for spawning commercially reared greater amberjack Seriola dumerili: Dose response and extent of the reproductive season

Reproduction control has been one of the main bottlenecks for the commercialization of greater amberjack Seriola dumerili, a promising species worldwide due to its rapid growth, large size and high market acceptability. Oocyte maturation, ovulation and spawning has been recently controlled successfully in a number of studies using hormonal therapies in the form of controlled-release delivery systems of Gonadotropin Releasing Hormone agonists (GnRHa). The objectives of the present optimization study were (a) to determine the most efficient GnRHa implant dose and (b) to examine the extent of the spawning induction period in greater amberjack reared in sea cages throughout the year, based on the resulting spawning kinetics, egg production and quality. Wild-caught greater amberjack were maintained in two commercial facilities, and were transferred to onshore tanks for spawning after treatment with GnRHa implants (a) of different doses (25 and 75 μg kg−1 body weight), or (b) at different times during the expected spawning season (June–July). Both doses were equally effective, and two consecutive implantations in 2 weeks resulted in mean (±SD) total relative fecundity of 185,221 ± 91,311 to 199,492 ± 16,973 eggs kg −1 in 11–18 spawns, without any significant differences in egg quality. Breeders maintained in sea cages were taken at different times and were induced to spawn successfully with a GnRHa implant of a recommended dose of 50 μg kg−1, during an effective period of at least 2 months when seawater temperature was 19–24 °C. The obtained information will contribute further to the delivery of an efficient egg production protocol to the aquaculture industry of the greater amberjack.

Efficacy of the XEN gel stent on intraocular pressure lowering in East Asian eyes.

This study aims to evaluate the efficacy and safety of XEN45 gel stent (Allergan plc, Dublin, Ireland) in East Asian patients with glaucoma. A retrospective study of consecutive XEN45 gel stent implantation surgeries with or without concurrent cataract surgery from May 2017 to August 2018 was performed in a single institution. The clinical charts of all cases were reviewed to examine the safety and efficacy of the implant. Primary outcome measures were intraocular pressure (IOP), number of topical glaucoma medications required, additional procedures done and adverse outcomes. All patients included were required to fulfil a minimum of three follow-up visits by post-operative month 1. Sixty-three eyes were included in the study. The median duration of follow-up was 6months [interquartile range (IQR) 2-9]. Median IOP was significantly lowered from 19mmHg (IQR 16-24) pre-operatively to 15mmHg (IQR 11-18) at the end-of-follow-up (p < 0.001). The median number of medications was reduced from 3 (IQR 2-4) at baseline to 0 (IQR 0-2) at the end-of-follow-up (p < 0.001). 66.7% of patients were medication-free by the end of follow-up. Post-operative bleb intervention was required for 61.9% of eyes. Adverse events included post-operative hypotony requiring intervention (4.8%) and post-operative gross hyphaema (9.6%). The XEN45 gel stent when used as a sole procedure or in combination with cataract surgery in East Asian eyes is effective in the treatment of glaucoma. However, a high rate of post-operative bleb intervention appears to be required to support its efficacy.

Vertebral Compression Fractures Treated in Acute by Instrumented Kyphoplasty: Early and Mid-Term Clinical and Radiological Results.

The treatment of traumatic low-degree vertebral compression fracture remains in a wide range between functional treatment, bracing, vertebroplasty, kyphoplasty, and even surgical fixation. The objective was to assess the innovation of instrumented kyphoplasty and to report the early and mid-term functional and radiological results. This study is a retrospective review of patients enrolled from 2012 to 2017. 104 consecutive endovertebral implantations of instrumented kyphoplasty were reviewed for the study. There were 56 women and 48 men. 93 of 104 patients were evaluated, of whom 27 were evaluated only by retrospective medical record review and 66 with follow-up visit. Clinical parameters were the pain rating scale (VAS) and the Oswestry score questionnaire. The radiological parameters were the vertebral kyphosis, vertebral height, lumbar lordosis, and adjacent disc degeneration (UCLA scale). Statistical correlations between before/after surgery/last follow-up were performed. The average follow-up was 26.7 months (3 to 55). The average VAS decreased from 8.2 to 3.2 the day after surgery, allowing immediate standup. The average Oswestry score was 14.6 at follow-up. The average vertebral kyphosis decreased from 12.9° to 6.5° post-op and stabilized at 8.0° at the last follow-up, corresponding to 28% gain on vertebral height. The lumbar lordosis was restored (+6.6°). Adjacent disc degeneration increased by 1 UCLA grade in 17 patients (16.3%) at follow-up. The instrumented kyphoplasty in acute led to immediate and lasting pain relief, with no bracing or bed rest, short stay in hospital, and quick return to daily life including professional activities. The good clinical results were associated to a stable radiological restoration of the vertebral anatomy.

The association of AGO1 (rs595961G>A, rs636832A>G) and AGO2 (rs11996715C>A, rs2292779C>G, rs4961280C>A) polymorphisms and risk of recurrent implantation failure.

Recurrent implantation failure (RIF) is a common reproductive clinical condition treated by fertility specialists at in vitro fertilization (IVF) clinics. Several factors affect embryo implantation including the age of the female, the quality of embryos and the sperm, genetics, immunologic factors. Here, we investigated the association of Argonaute 1 (AGO1) and Argonaute 2 (AGO2) polymorphisms and RIF. We collected blood samples from 167 patients with RIF and 211 controls. Genetic polymorphisms were detected by polymerase chain reaction (PCR) – restriction fragment length polymorphism analysis and real-time PCR. We found that the AGO2 rs4961280C>A polymorphism (adjusted odds ratio [AOR] = 1.984; P = 0.023) was significantly associated with RIF. Furthermore, in RIF patients with three or more consecutive implantation failure, the AGO2 rs4961280C>A CA genotype (AOR = 2.133; P = 0.013) and dominant model (AOR = 2.272; P = 0.006) were both significantly associated with prevalence of RIF. An analysis of variance revealed that patients with the AGO2 rs2292779C>G genotypes (CC: 6.52 ± 2.55; CG: 7.46 ± 3.02; GG: 8.42 ± 2.74; P = 0.044) and the dominant model (CC: 6.52 ± 2.55; CG+GG: 7.70 ± 2.97; P = 0.029) exhibited significantly increased white blood cell levels. Furthermore, patients with the AGO1 rs595961G>A dominant model (GG: 36.81 ± 8.69; GA+AA: 31.58 ± 9.17; P = 0.006) and the AGO2 rs4961280C>A recessive model (CC+CA: 35.42 ± 8.77; AA: 22.00 ± 4.24; P = 0.035) exhibited a significantly decreased number of CD4+ helper T cells. Our study showed that AGO1 and AGO2 polymorphisms are associated with the prevalence of RIF. Hence, the results suggest that variations in AGO1 and AGO2 genotypes may be useful clinical biomarkers for the development and prognosis of RIF.

P6561Diagnostic yield of implantable loop recorders: a comparison of arrhythmia nurse specialists versus clinicians

Abstract Background Implantable loop recorders (ILR) are recommended in guidelines to determine symptom-rhythm correlation. Arrhythmia Nurse Specialists (ANS) play a critical role in the assessment of such patients. Their effectiveness at risk stratification for ILR implantation is unknown. The ESC 2018 Syncope guidelines recommend more research in this field. Aim To evaluate the diagnostic yield of consecutive ILR implants at a tertiary centre over a 2year period and compare ANS versus Clinicians. Methods A retrospective study of all patients undergoing ILR implant between April 2016 and April 2018. Data collected included baseline patient demographics, referral source and management changes made by ILR findings. Results 305 patients had an ILR; median age was 71yrs (interquartile range 52–81), 55% male. Median follow-up time was 15months. Referrals were from general cardiology (GC) = 98 (32%), electrophysiology (EP) = 105 (34%), and ANS-led syncope clinic = 102 (34%). Indications for ILR implant were syncope = 203 (65.9%), palpitation = 21 (6.9%), pre-syncope = 16 (5.2%), cryptogenic stroke = 35 (11.5%) and others 7 (8.9%) (falls, channelopathies). Of the entire cohort, 102 (34.0%) experienced arrhythmias recorded on the ILR that resulted in a change of management. This included: pacemaker implant = 49 (16.1%), complex-device implant = 7 (2.3%), AF=28 (9.2%), SVT=14 (4.6%), VT=1 (0.3%). Of those with a syncope indication (n=203), findings on ILR altered management in 73patients (36.0%) over a median follow-up of 18months; a pacing indication in this syncope group was present in 44 (21.9%) patients (median time to diagnosis: 2.7 months) with 24 receiving a pacemaker indication within 3 months of ILR insertion. ANS had a higher pacemaker implant rate. Overall, an ILR resulted in a diagnostic yield of 34.1% (n=104). Specialist nurse referral resulted in an overall greater trend towards change of management in 38.2% of patients compared with GC (32.7%) and EP (31.0%) (p=0.593 nurse vs. consultant). Conclusion The overall diagnostic yield of ILR insertion was 34% in our study. ANS had a trend towards a greater diagnostic yield compared with clinicians, and significantly more pacemaker indications. Our data suggests that ANS patient selection for ILR insertion are at least comparable to clinicians.

Comparative Outcomes of Balloon-Expandable S3 Versus Self-Expanding Evolut Bioprostheses for Transcatheter Aortic Valve Implantation

To date, comparisons between the balloon-expandable Edwards Sapien S3 (S3) versus the self-expanding Evolut R or PRO (Evolut) valves have been limited with respect to procedural outcomes. We aim to compare the safety, efficacy, and procedural efficiency of the S3 versus the Medtronic Evolut bioprostheses in patients who underwent transcatheter aortic valve implantation for severe aortic stenosis. Retrospective analysis was performed of all consecutive transcatheter aortic valve implantation procedures performed through the transfemoral approach with either S3 or Evolut at our hospital between September 2015 and January 2019. A total of 581 patients were included. There were no significant differences between S3 (n = 452) and Evolut (n = 129) concerning in-hospital or 30-day safety outcomes. S3 was associated with significantly shorter fluoroscopy times, lower fluoroscopy Air Kerma, and higher contrast use. S3 had lower postprocedure aortic valve area (1.71 ± 0.45 vs 1.84 ± 0.50 cm2, p = 0.004), larger peak gradient at 30 days (10.7 ± 3.8 vs 7.0 ± 3.2 mm Hg, p <0.001), and lower aortic regurgitation (AR) rates postprocedure (47% vs 33%, p = 0.024) and at 30 days (50% vs 33%, p = 0.008), driven by mild AR. Device type was an independent predictor of AR postprocedure and at 30 days. Patients with ≥mild AR were more likely to have had Evolut valves (odds ratio = 2.94, p <0.001), especially in larger valves (>26 mm). Severe prosthesis-patient mismatch was higher in S3 (14.8% vs 7.9%, p <0.001). In conclusion, S3 is associated with less radiation exposure, higher contrast use, and lower incidence of AR at 30 days. Alternately, S3 has a higher transaortic gradient at 30 days, and higher levels of severe prosthesis-patient mismatch.

Removal of failed dental implants revisited: Questions and answers.

ObjectivesThis narrative review is aiming on showing reasons for implant failure, removal techniques, and respective clinical considerations; further, the survival rate of implants in previous failed sites is examined.Materials and methodsQuestions have been formulated, answered, and discussed through a literature search including studies assessing implant failure and removal up to 2018.ResultsStudies describing reasons for implant failure, implant removal techniques, and the reinsertion of implants in a previous failed site (n = 12) were included. To date, peri‐implantitis is the main reason for late implant failure (81.9%). Trephine burs seem to be the best‐known method for implant removal. Nevertheless, the counter‐torque‐ratchet‐technique, because of the low invasiveness, should be the first choice for the clinician. Regarding zirconia implant removal, only scarce data are available. Implantation in previously failed sites irrespective of an early or late failure results in 71% to 100% survival over 5 years.ConclusionIf removal is required, interventions should be based on considerations regarding minimally invasive access and management as well as predictable healing. (Post)Operative considerations should primarily depend on the defect type and the consecutive implantation plans.

Risk Analysis of Hemorrhages in Stereo-Electroencephalography Procedures

Abstract INTRODUCTION Despite the variations in the implantation techniques used, stereo-electroencephalography (SEEG) has been reported to be quite safe with a major complication incidence of less than 1%. While some studies have attempted to classify complications, there is currently no standardized or evidence-based method for either the detection or reporting of complications in SEEG, in particular, hemorrhages. As a result, clinicians examining the current literature rely on centers reporting “clinically significant,” or “major” complications which can be arbitrarily and vaguely defined in each specific instance. METHODS This was a retrospective, single center observational study examining every SEEG implantation performed at our center from 2009 to 2017. This consisted of 549 consecutive SEEG implantations using a variety of stereotactic and imaging techniques. A hemorrhage grading system was applied by a blinded neuroradiologist to every postimplant and postexplant CT scan. Hemorrhages were classified as asymptomatic or symptomatic based on neurological deficit seen on exam. Statistical analysis included multivariate regression using relevant preoperative variables to predict the presence of hemorrhage. RESULTS A toal of 105 implantations (19.1%) had any type of hemorrhage seen on postimplant CT. Of these, 93 (16.9%) were asymptomatic and 12 (2.2%) were symptomatic with 3 implantations (0.6%) resulting in either a permanent deficit (2, 0.4%) or death (1, 0.2%). Male sex, increased number of electrodes and increasing age were associated with increased risk of postimplant hemorrhage on multivariate analysis. Increasing score in the grading system was related to a statistically significant increase in the likelihood of a symptomatic hemorrhage. CONCLUSION Detailed examination of every postimplantation CT reveals that the total hemorrhage rate appears higher than previously reported. Most of these hemorrhages are small and asymptomatic. Our grading system may be useful to risk stratify these hemorrhages and awaits prospective validation.

Long-term results of stenting of long coronary artery stenosis with consecutive implantation of stents of different types with overlapping edges in patients with acute coronary syndrome without ST-segment elevation and multivessel coronary artery disease

Introduction. In urgent interventional cardiology practice, combinations of drug-eluting stents and bare-metal stents are sometimes forced to treat extended stenosis in a clinic-dependent artery.&#x0D; Objective. A comparison of long-term results of treatment of patients with coronary heart disease and multivessel coronary lesions, which performed stenting of the clinic-dependent artery by two successive partially overlapping stents using stents of the 3rd generation with drug coating or a combination of the 3rd generation stent with drug coating and a bare-metal stent for acute coronary syndrome without St segment elevation and later — complete functional myocardial revascularization by endovascular method.&#x0D; Methods. The minimum overall length sentiremos section was made 55 mm. In main group included 32 patients for whom revascularization clinic-dependent artery performed endovascular intervention with the use of 2 stents 3-generation drug-coated sirolimus and biodegradable polymer implanted overlap. In 30 patients (control group), clinic-dependent artery revascularization was also performed by a combination of implanted overlap stents, one of which was a 3rd generation stent with sirolimus drug coating and biodegradable polymer, and the other was a bare-metal stent. There were no statistically significant differences between the groups in clinical, demographic and operational characteristics.&#x0D; Results. The analysis of the results revealed a significant difference between the groups in the frequency of repeated revascularization of the target artery, which were observed more often in the control group.&#x0D; Conclusion. When performing an extended stenting of the clinic-dependent artery in patients with acute coronary syndrome without ST segment elevation, overlapping of the drug-coated stent and the bare-metal stent should be avoided, since the antirestenotic effect of the drug-coated stent is leveled when overlapping with the bare-metal stent, but this strategy can be used in case of full coverage of the stenotic lesion or closure of the dissection.

Outcomes of Using Sutureless, Scleral-Fixated Posterior Chamber Intraocular Lenses

ABSTRACTBackground. Implantation of sutureless, scleral-fixated posterior chamber intraocular lenses (SSFIOL) is a promising option in the surgical management of patients unable to undergo standard cataract surgery due to insufficient capsular support. The purpose of this study was to describe the indications, visual outcomes and complications of SSFIOL implantation.Methods. Retrospective, investigational cohort study of 112 consecutive SSFIOL implantations between July 2013 and August 2017. Pre-operative ocular morbidity, operative indications, postoperative outcomes, complications, and reinterventions were summarized. Visual and refractive outcomes were compared between the pre- and latest postoperative visit using Wilcoxon signed-ranked test.Results. Mean follow-up: 13.0 ± 10.4 months. Primary surgical indication was dislocated IOL due to zonular weakness (77 eyes (68.8%)). At latest follow-up, there was improvement in uncorrected visual acuity (1.3 ± 0.8 to 0.64 ± 0.60 logMAR, p < .01), best-corrected visual acuity (BCVA) (0.6 ± 0.5 logMAR to 0.36 ± 0.40 logMAR, p < .01). Postoperative complications included transient IOP elevation >30 mmHg (26.8%), cystoid macular edema (CME) (14.3%), transient hypotony (13.4%), iris capture (12.5%), uveitis-glaucoma-hyphema (UGH) syndrome (11.6%), vitreous hemorrhage (VH) (6.3%). Operative reinterventions included SSFIOL exchange (3.6%), SSFIOL repositioning (5.4%), SSFIOL removal (2.7%). Ten (8.9%) patients required multiple re-interventions.Conclusion. SSFIOL implantation is a reasonable option for eyes with inadequate capsular support, resulting in visual improvement in most patients. Many of the surgical complications were related to a floppy iris-lens diaphragm (UGH syndrome, iris capture), which were predisposed in eyes with complex pathology. Surgical modifications can be made to minimize the iris-related complications.

Localizing radioimmunotherapy via nanochannel device for sustained intratumoral drug delivery for solid tumor treatment.

37 Background: Immune related adverse events still occur in up to 91% of patients receiving immunotherapy. Intratumoral administration is a potential solution to limit these events by reducing systemic exposure while increasing local concentration. However, intratumoral injection is hindered by rapid clearance of drug from the tumor. Our group has developed an intratumoral nanochannel implant for sustained delivery of immunotherapy (NDES) as a solution. Recent clinical and preclinical studies have found success in the combination of radiotherapy and immunotherapy in improving both local and distant tumor response. We propose a combination of radiotherapy followed by sustained intratumoral delivery of immunotherapy as a treatment regimen to improve tumor response and reduce side effects. Methods: Mice were implanted with the 4T1 murine mammary carcinoma and separated into treatment and control groups. CD40 agonist antibody was delivered intratumorally via NDES. Radiotherapy was administered at 8 Gy for three consecutive days and implantation of the NDES occurred the day after the final fraction of radiation. The tumor growth curve was plotted and tumor, spleen, lymph nodes, lungs, and blood were collected at the study endpoint for further flow cytometry and histological analysis. Results: The combination of radiotherapy and sustained intratumoral CD40 antibody showed significantly decreased tumor growth rates over radiotherapy or sustained intratumoral immunotherapy alone. Both intratumoral and systemic T-cell activation was observed. Mice treated with sustained intratumoral CD40 antibody showed decreased toxicity when compared to those receiving comparable systemic dosage. Conclusions: Radiotherapy combined with local sustained intratumoral immunotherapy is a potential strategy for improving treatment of solid tumors which currently show suboptimal response to current immunotherapy regimens and for inducing a systemic response to distant metastases while minimizing adverse side effects. The sustained delivery profile of the NDES presents an opportunity for practical intratumoral administration and avoidance of repeated invasive procedures in patients.

Single-center evaluation of a next generation fully repositionable and retrievable transcatheter aortic valve replacement

BackgroundThe mechanically expandable Lotus Valve System is a fully repositionable and retrievable valve with an adaptive seal to minimize paravalvular leak (PVL). The aim of this study was to evaluate the short- and long-term safety and efficacy of the new device with focus on a new implantation technique to reduce the need for a permanent pacemaker (PPM) post procedure.MethodsWe performed a prospective single-center, non-randomized evaluation of the Lotus Valve System. The first 100 consecutive Lotus Valve implantations were included in the analysis. Outcome was assessed according to VARC2-criteria. Postoperative pacemaker rates were assessed using the national pacemaker registry and electronic medical records. Mortality at 30 days and 12 months were acquired from the national population registry.ResultsMean age was 82.7 ± 5.6 years, mean Euroscore I was 25.3 ± 14.5%, mean STS-score was 6.5 ± 4.1% and mean aortic valve area was 0.6 ± 0.1 cm2. There were no cases of valve embolization, ectopic valve deployment or additional valve implantation. Device success according to the VARC2-criteria was 97%. The 30-day mortality rate was 3%. Two deaths occurred due to stroke and one due to a ventricular rupture. Major stroke rate was 2% and major vascular complication rate was 2%. The 12-month mortality rate was 14%. At discharge 87% of patients had no/trace PVL, 12% had mild PVL and one patient had a moderate PVL. A total of 13% received a new PPM post valve implantation. Among patients who did not have a PPM before the procedure, the PPM rate was 15.3%.ConclusionsThis single-center evaluation of the Lotus Valve System demonstrated a good clinical outcome with a low mortality, in a high-risk population. Introduction of a new implantation technique resulted in lower PPM rates than previously reported without negatively affecting PVL.Trial registrationCurrent Controlled Trials ISRCTN14952278, retrospectively registered 06/11/2017.