Post Implantation Research Articles

P98 A CASE OF “RECURRENT” AORTIC VALVE STENOSIS

Abstract Clinical Case A 80–year–old man underwent coronary angiography in 2006 because of stable angina. There was chronic total occlusion of middle left anterior descending artery requiring percutaneous intervention. In 2009 he underwent coronary angiography for recurrent angina: a severe stent restenosis was treated with stenting in stent (DES in BMS). The patient was subsequently asymptomatic till 2018 when he complained of exertional dyspnea and angina. Stent patency and severe aortic valve stenosis (AVA 0.85 cm2) were documented. The patient underwent successful transcatheter aortic valve implantation and discharged with dual antiplatelet therapy (DAPT) (Asa 100 mg and Clopidogrel 75 mg). Clinical and echocardiographic follow–up was unremarkable (mean prosthetic gradient 17 mmHg, DVI=0.45). In July 2021 during a cardiological check the patient complained of bruising: ASA was discontinued. In February 2022 the patient suffered from an exertional angina. A dipyridamole stress–echocardiography failed to demonstrate inducible ischemia, although the patient experienced angina at the peak load step. Transthoracic echocardiogram (TTE) revealed high mean trans–prosthetic aortic gradient (52 mmHg, DVI=0.18). A trans–esophageal echocardiogram (TEE) showed reduced mobility of the thickened left coronary and non–coronary aortic prosthetic leaflets. In the hypothesis of prosthetic valve thrombosis, warfarin (INR range 2–3) was started after stopping clopidogrel. After three months a TTE showed normalized mean trans–prosthetic gradients (17 mmHg, DVI=0.5). When a 6 month–period of anticoagulant therapy was accomplished, warfarin was stopped and DAPT administered again. In September 2022 the patient complained of worsening dyspnea and chest pain on exertion. At TTE mean trans–prosthetic gradients (46 mmHg) was increased. A new TEE showed thickening of non–coronary and right coronary leaflets, suggestive of recurrent valve thrombosis. After stopping DAPT, warfarin was started again with good result (mean prosthetic gradient 12 mmHg, DVI=0.5). Conclusion Thrombosis of aortic valve prothesis is an infrequent event usually occurring in early post–implantation period. In our case it occurred four years after implantation following DAPT interruption. The likely initial prosthetic valve degeneration together with a simplification of DAPT may have had a causative role. Since the proved efficacy of warfarin and the limited experience of DOAC in this field, the patient was given warfarin sine die.

Adipose-Derived Mesenchymal Stem Cells Attenuate Immune Reactions Against Pig Decellularized Bronchi Engrafted into Rat Tracheal Defects

ABSTRACT Decellularized scaffolds are promising biomaterials for tissue and organ reconstruction; however, strategies to effectively suppress the host immune responses toward these implants, particularly those without chemical crosslinking, remain warranted. Administration of mesenchymal stem cells is effective against immune-mediated inflammatory disorders. Herein, we investigated the effect of isogeneic abdominal adipose-derived mesenchymal stem/stromal cells (ADMSCs) on xenogeneic biomaterial-induced immunoreactions. Peripheral bronchi from pigs, decellularized using a detergent enzymatic method, were engrafted onto tracheal defects of Brown Norway (BN) rats. BN rats were implanted with native pig bronchi (Xenograft group), decellularized pig bronchi (Decellularized Xenograft), or Decellularized Xenograft and ADMSCs (Decellularized Xenograft+ADMSC group). In the latter group, ADMSCs were injected intravenously immediately post implantation. Harvested graft implants were assessed histologically and immunohistochemically. We found that acute rejections were milder in the Decellularized Xenograft and Decellularized Xenograft+ADMSC groups than in the Xenograft group. Mild inflammatory cell infiltration and reduced collagen deposition were observed in the Decellularized Xenograft+ADMSC group. Additionally, ADMSC administration decreased CD8+ lymphocyte counts but increased CD163+ cell counts. In the Decellularized Xenograft+ADMSC group, serum levels of vascular endothelial growth factor and IL-10 were elevated and tissue deposition of IgM and IgG was low. The significant immunosuppressive effects of ADMSCs illustrate their potential use as immunosuppressive agents for xenogeneic biomaterial-based implants.

Abiotrophia defectiva: A rare and lethal but an easy miss!

Abiotrophia defectiva is a nutritionally deficient streptococci, a rare pathogen of infective endocarditis (IE) in children but is frequently known to cause valvular dysfunction and embolic complications. Only nine cases of A. defectiva endocarditis have been reported so far in world literature. We report a case of A. defectiva endocarditis in a 7-year old girl, with a small peri membranous ventricular septal defect with congenital bilateral sensorineural hearing loss status post left-sided cochlear implantation who presented with prolonged fever. A. defectiva should be considered in children with endocarditis with a subacute course and atypical presentations. Although fastidious in growth it is a virulent bacterium preferentially affecting endovascular structures and is implicated in many culture negative endocarditis. Our case reiterates the possibility of a rare cause of this common disease and the challenges encountered while isolating this nutritionally deficient organism and its treatment.

PO-01-047 EVALUATION OF EARLY REMOVAL OF FIGURE-OF-EIGHT SUTURE POST LEFT ATRIAL APPENDAGE CLOSURE DEVICE IMPLANTATION

Left atrial appendage closure device implantation (LAAC) is being performed increasingly in appropriate pts for stroke prevention. We report single center experience in outcomes in patients (pts) prior to and after implementation of a strategy of early (2 hr) removal of figure-of-eight (FO8) suture post LAAC device implantation. To assess if early removal of FO8 suture is safe post LAAC device implantation. We reviewed charts of consecutive pts who underwent LAAC device implantation between May, 2021 – Nov, 2022 in whom FO8 suture was used for hemostasis. In Sept, 2022 strategy to remove FO8 suture 2 hr post procedure was implemented. Complications rates were collected post procedure. Comparisons were made using intention to treat analysis. Group A (May 2021 to Aug 2022) included 55 pts (37 males; mean age 77.4 yrs) who had FO8 suture removed > 2hr. Group B (Sept 2022 to Nov 2022) included 24 pts (13 males; mean age 76.6 yrs) who had FO8 suture removed 2 hr post procedure. Baseline characteristics of pts are presented in Table 1. No significant differences were noted in rate of complications prior to discharge (Group A vs Group B, 7 vs 3; p 0.97). In Group B, 2 minor complications, not requiring significant intervention, were noted prior to discharge and one pt stayed > 24 hrs in hospital due to non-procedure related clinical issues. ACT levels (Group A vs Group B, 289 vs 325; p 0.018) and antiplatelet use (Group A vs Group B, 32.8 vs 56.3. p 0.000) was higher in Group B. Our data suggests early removal of FO8 suture post LAAC device implantation appears safe.Tabled 1Table 1Group AGroup BP valueTotal pts5524Male (%)6754BMI31.6329.750.23Chads Vasc Score4.384.540.59Has Bled Score3.553.460.70ACT2893250.018Procedure time (min)48.844.70.40Antiplatelet (%)32.8656.34.00Anticoagulant (%)40.0439.920.97 Open table in a new tab

PO-05-027 INCIDENCE OF PACING-INDUCED CARDIOMYOPATHY AND NEED FOR CARDIAC RESYNCHRONIZATION THERAPY UPGRADE IN PATIENTS WITH LEADLESS PACEMAKER: LONG TERM FOLLOW-UP OF 75 PATIENTS

Excessive right ventricular (RV) pacing with traditional pacemaker has been associated with a 17-25% risk of pacing-induced cardiomyopathy (PICM), defined as a decrease of left ventricular ejection fraction by 10% or more. The risk of PICM with more septally placed leadless pacemaker is unknown. We aimed to report the incidence of PICM in patients with leadless pacemaker and the need for cardiac resynchronization therapy (CRT) upgrade. We performed a single-center analysis of patients who underwent leadless pacemaker implantation between January 1, 2014 and April 1, 2022. Patient echocardiogram result pre and post implantation were collected. The outcomes of this study included the incidence of PICM in leadless pacemaker implant patient, the rate of CRT upgrade, RV pacing percentage, total RV pacing time and follow up duration. The definition of total RV pacing time was the duration from pacemaker to last follow up multiplied by RV pacing percentage. A total 75 patients underwent leadless-pacemaker implantation were included in this study. The mean age was 80 ± 8.5 year-old. Indications for single chamber leadless implantation include sick sinus syndrome and bradycardia. Mean duration of follow up was 14.6 months. The RV pacing percentage was 64.4 ± 38.58 %.The mean RV pacing time was 9.2 ± 1.4 months, PICM was found in 32 patients (44%), 10 patients (13.5%) required CRT upgrade due to congestive heart failure symptoms. The mean duration between implantation of leadless pacemaker to upgrade CRT was 372 ± 489.8 days. The incidence of PICM in leadless pacemaker patients was 44% and 13.5 % of patients required CRT upgrade within 2 years after the leadless pacemaker implant in the majority of the patients. Further studies are necessary to confirm these findings.

PO-04-192 RISK FACTORS AND OUTCOMES OF ELECTRICAL STORM AFTER LEFT VENTRICULAR ASSIST DEVICE IMPLANTATION

Electrical storm after Left Ventricular Assist Device (LVAD) is a recognized complication. The risk factors associated with electrical storm, impact on survival is less studied. The aim of this study is to study the incidence, risk factors of electrical storm after LVAD implantation and the impact of electrical storm on survival in patients undergoing LVAD. We performed a retrospective cohort study of all patients who underwent the LVAD implantation from January 1, 2001, to December 31, 2020, at the Mayo Clinic (Rochester, Phoenix, and Jacksonville). The incidence and outcomes of electrical storm (≥3 sustained [>30 seconds] ventricular arrhythmia episodes over a 24-hour period) were identified. Among 886 patients who underwent LVAD implantation, electrical storm occurred in 61 (7%) patients after median of 13 days (interquartile range [IQR] 4.5- 302) post LVAD implantation. Thirty-five patients (57.3%) developed electrical storm within 30 days, while 26 patients (42.6%) developed ES at a median of 689 days (IQR of 228-1171) after LVAD. Pre LVAD history of ventricular arrhythmias (43% vs 25%, p-value=0.002) and implantable cardioverter-defibrillator (ICD) shock (34% vs 22%, p-value=0.024) and history of were significantly associated with electrical storm after LVAD implantation. The 1-year mortality rate after first occurrence of electrical storm was 38%. Following LVAD implantation, the rate of electrical storm was 7% with majority of electrical storm occurring within 30-days of LVAD. Risk factors for electrical storm included pre-implant history of ventricular arrhythmias and ICD shock.

PO-03-074 INITIAL HEART RATE SCORE IS PREDICTOR FOR OCCURRENCE OF NEW ATRIAL FIBRILLATION INDEPENDENT OF WELL-KNOWN RISK FACTORS AND RELATES TO RIGHT ATRIAL PACING RATE IN PACEMAKER PATIENTS

Heart Rate Score (HRSc), the percent of right atrial (RA) beats in the largest paced or sensed 10-bpm histogram bin, predicts survival in ICD and CRT-D patients without atrial fibrillation (AF). For pacemaker (PM) patients, although age, gender and RA and right ventricular pacing percent (% RA and RV pacing) have been related to AF, the relationship of HRSc to subsequent AF is unknown. To evaluate the relationship between initial post implantation HRSc and incidence of newly developed AF, and well-known predictors for AF in PM patients. Patients with dual-chamber, atrial tracking PMs, implanted 2013-2017, who had ALTITIUDE remote monitoring data available, were included. HRSc was determined from histogram data during the first 3 months post-implant. Only patients with ≥600,000 beats of histogram data collected at baseline were included. Patients with single-chamber or biventricular PMs were excluded. Patients were excluded if they had AF, defined as atrial high rate episodes >5 minutes or >1% of RA beats >170 bpm during the initial 3-months post-implant. AF after the baseline period was evaluated by the definition: >1% of atrial beats >170 bpm. Sinus node disease (SND) was defined as needed for RA pacing ≥ 40% and atrio-ventricular block (AVB) as needed for right ventricular pacing ≥ 20% during the baseline period. Of the total population (N=34,543), 15,252 patients had device-determined SND and 16,190 patients had AVB. Utilizing multivariable analysis, the initial HRSc (HR: 1.07, 95% CI: 1.05-1.09; P<0.0001) independently predicted subsequent AF after adjusting for age, gender, % RV pacing and rate-response programming. Patients with initial HRSc≥70% were older, and had higher % RA pacing, lower % RV pacing and were more likely programmed with rate-response vs subjects with initial HRSc<70%. There was a direct, and significant, increase in new-onset AF with each 20% increment in HRSc and/or % RA pacing (both P<0.001, Figure) during median of 2.8 (1.0-4.0) years follow-up. The %RA pacing and initial HRSc were strongly correlated (Pearson correlation coefficient=0.9). % RV pacing did not predict AF. Both SND patients and AVB patients with initial HRSc≥70% had a significantly increased risk of AF (log-rank P <0.001) compared to patients with HRSc<70%. Initial HRSc, strongly related to percent RA pacing, predicts subsequent AF independent of well-known risk factors in both device-determined SND and AVB.

CI-452767-1 THE ASSOCIATION BETWEEN QRS NARROWING WITH CARDIAC RESYNCHRONIZATION THERAPY, MORTALITY AND HEART FAILURE: A POST-HOC ANALYSIS OF THE RESYNCHRONIZATION IN AMBULATORY HEART FAILURE TRIAL (RAFT)

Amongst patients with left ventricular systolic dysfunction and prolonged QRS, cardiac resynchronisation therapy (CRT) can improve cardiac electrical/mechanical synchrony, and prevent adverse clinical outcomes. The baseline QRS duration is associated with improved response to CRT. However, the association between QRS narrowing after implantation and clinical response to CRT is unclear. To determine whether the degree of QRS narrowing is associated with clinical outcome following CRT implantation. The RAFT study enrolled 1798 patients with left ventricular ejection fraction (LVEF) ≤35%, QRS duration ≥120 ms and NYHA II-III to CRT-D or ICD. 894 were randomized to CRT-D of which 821 patients received CRT-D and had electrocardiograms (ECGs) available for review. The degree of QRS narrowing (dQRS) was calculated as the difference between baseline QRS duration and the widest QRS with CRT pacing post implantation. The primary outcome was a composite of death and heart failure hospitalisation. Multivariable Cox proportional hazards models were performed to assess the association between dQRS and the incidence of the primary composite outcome. To model the variation in risk of the outcome by dQRS, a restricted cubic spline function was used. The median age was 67 (IQR 59-73) years, 125 patients (15.2%) were women, median LVEF 24%, 68% had ischemic heart disease and 30% had atrial fibrillation. The baseline median QRS duration was 160 (IQR 140-178.5) ms, 68% had a left bundle branch block (LBBB). The median dQRS was 2 ms (IQR -18-20 ms), and 450 (55%) of patients had QRS narrowing post CRT. dQRS was associated with a reduction in the composite outcome (HR = 0.988, 95% CI 0.984-0.993), all-cause mortality (HR = 0.990, 95% CI 0.984-0.995) and heart failure hospitalisation (HR 0.990, 95% CI 0.985-0.997) in patients with CRT, following adjustment for age, sex, non-ischaemic cardiomyopathy, LVEF, atrial fibrillation/flutter, NHYA class, and peripheral vascular disease (Figure 1A). Similar findings were seen in the group without LBBB at baseline (HR 0.992, 95% CI 0.985-0.999) (Figure 1B). Amongst patients receiving CRT for left ventricular systolic dysfunction with QRS prolongation, any degree of QRS narrowing was found to be associated with an increasing reduction in mortality and heart failure, irrespective of the QRS morphology at baseline. This finding may improve outcomes in patients undergoing CRT implantation, particularly in those with a non-LBBB QRS morphology.

Cochlear implantation in children with congenital inner ear malformations - Our experience

To share our experience of the surgical challenges faced in cochlear implanted patients with inner ear malformation and to assess the auditory and speech perception outcomes. Clinical records of 502 cochlear implant procedures were reviewed and data of 122 patients who had inner ear malformations were enrolled in the study. Their auditory and speech performances were evaluated post implantation for 3 years. Cerebrospinal fluid gusher was encountered during opening of cochlea in 42 patients (34.4%) and one patient was re-explored within 24h. In 30.3% of cases facial anomaly was found. Significant improvement in average performance was seen in all malformation types except in cochlear hypoplasia at 12 months postoperatively. Surgical challenges can be overcome with expertise and giving special attention to preoperative imaging. Our experience suggests that outcomes are favourable in patients with inner ear malformations too.

Immediate and late inflammatory and bone healing response post implantation of self-tapping and self-drilling osteosynthesis screws

The aim of this study was to comparatively analyse osseointegration after the implantation of self-tapping screws (STS) and self-drilling screws (SDS). Thus, 24 four-month-old male Wistar rats, received SDS and STS screws in their left and right tibias, respectively. Sample collection was performed immediately at 0 hours (0h), two, seven, and 21 days after implantation (2d, 7d, 21d). Samples from immediately and 21 days after were analysed by micro computed tomography (MicroCT). All time points were evaluated by histology (Haematoxylin and Eoisin and Goldner's Trichrome) and immunohistochemistry for tartrate-acid resistant phosphatase positive (TRAP+) osteoclasts. MicroCT images revealed an intimate contact between bone and each type of screw at 0h. However, SDS group presented decreased bone volume (BV, mm3) at 21 days in comparison with STS. Both SDS and STS post implantation presented areas of suitable new bone formation surrounding screw threads from seven days, and inflammation decreased from two to 21 days. Also, TRAP+ osteoclasts were mainly identified at seven days in both STS and SDS groups, particularly surrounding areas of pressure, with significant differences between groups. In conclusion, differences in shape and insertion technique for SDS and STS screws did not affect immediate and late inflammatory and bone healing response post implantation in this animal model. Both osteosynthesis screws allowed satisfactory post-surgical outcomes.

Incidence of stroke in patients with hypertrophic cardiomyopathy in stable sinus rhythm during long-term monitoring

IntroductionPatients with hypertrophic cardiomyopathy (HCM) are at increased risk of stroke, but the incidence and factors associated with cardioembolic events in HCM patients without atrial fibrillation (AF) remain unresolved. We determined the incidence of stroke in patients in sinus rhythm (SR) monitored with a cardiac implantable electronic device (CIED). MethodsAll consecutive patients diagnosed with HCM and referred to CIED implantation with >16 years at diagnosis and ≥ 1 year follow-up post CIED implantation were retrospectively reviewed. Severe LA dilatation was defined as ≥48 mm. Patients were stratified by rhythm as: Pre-existing AF (AF present prior to CIED); De novo AF (AF present after CIED implantation); SR: no episodes of AF. ResultsOf 1651 patients, 185 (11.2%) implanted with a CIED were included (57% men, age: 54 ± 17 years). Baseline, pre-existing AF was present in 73 (39%) patients. Ischemic stroke was reported in 19 (10.3%, 1.78%/year) patients and was similar across the three groups (2.3%/year vs 1.1%/year vs 0.6%/year in patients in SR vs pre-existing AF vs de novo AF, respectively, p = 0.235).In SR patients, a LAD≥48 mm posed the greatest risk of stroke (Hazard Ratio: 10.03,95% Confidence-Interval 2.79–16.01). At Cox multivariable analysis, after adjustment for oral anticoagulation, LA was independently associated with stroke while rhythm was not. Conclusionsin HCM patients with CIED long-term monitoring and no prior history of AF, stroke rates were similar in those with de novo AF or stable SR. Severe LA dilatation was a powerful risk factor, irrespective of AF.

Endoplasmic reticulum stress response and the regulation of endometrial interferon-beta production

To gain an understanding of the potential role of endoplasmic reticulum (ER) stress in the endometrial compartment during early pregnancy, a highly understudied area. This study examined the regulation of interferon-β (IFNβ) in response to ER stress in human decidualized and nondecidualized endometrial cells (human endometrial stromal cells [HESCs]) invitro. Invivo, we examined ER stress and the IFNβ levels locally in the mouse endometrium before and after implantation at embryonic day (E)1, E3, and E6. The study was performed in a reproductive sciences laboratory for Human Growth and Development. None. None. Quantitative polymerase chain reaction, Western blotting, and immunohistochemical analysis allowed us to test the action of endogenous ER stress activation in the endometrial compartment likely triggered by implantation and its ability to increase the endometrial IFNβ levels. Invitro, we observed a significant difference in the IFNβ levels in HESCs, in response to ER stress activation, where decidualized HESCs exhibited a threefold increase in the IFNβ levels compared with nondecidualized HESCs. Apoptotic caspase-3 activation was also isolated to the decidualized cells as a result of ER stress-dependent suppression of nuclear factor-kappa beta-regulated antiapoptotic factors, XIAP and MCL-1. Invivo, mouse endometrial IFNβ was present in F4/80-positive macrophages at all time points examined. After implantation (E6), the mouse luminal epithelial cells robustly coexpressed both IFNβ and the ER stress marker immunoglobulin heavy chain binding protein (BiP). These analyses demonstrate that both invivo and invitro, differentiated and decidualized endometrial cells undergoing ER stress have the capacity to produce increased IFNβ levels; therefore, ER stress activation in the endometrial compartment may play a vital role in promoting successful implantation events.

510 Prospective, Multicenter, International Outcomes Study of Deep Brain Stimulation for Essential Tremor

INTRODUCTION: Essential Tremor (ET) treatment is focused on medical management of motor symptoms and includes pharmacotherapy and ventral intermediate nucleus (VIM) thalamotomy, which is being largely replaced by thalamic Deep Brain Stimulation (DBS) as the surgical treatment of choice. DBS of the VIM thalamus is recommended as a therapeutic option for appropriate subjects with ET (Elble RJ., et al. Expert Rev Neurother. 2018). METHODS: This is a prospective, on-label, multi-center, international DBS outcomes study conducted at up to 50 implanting centers. All participants are implanted with a multiple-source, constant-current directional DBS system (Vercise, Boston Scientific). Subjects are followed for up to 3-years post implantation where their overall improvement in quality of life and ET symptoms are evaluated. Clinical endpoints evaluated at baseline and follow-up timepoints include: The Essential Tremor Rating Assessment Scale (TETRAS), Quality of Life in Essential Tremor Questionnaire (QUEST), Fahn-Tolosa-Marin Rating Scale (TRS), and Global Impression of Change. Adverse events also collected. RESULTS: To date, 18-implanted subjects with a mean disease duration of 15.1 ± 14.6-years and a baseline QUEST Summary Index score of 35.0 ± 12.4. At 6-months post-DBS, a clinically significant improvement in quality of life (∆ = 19.5-point change in QUEST SI score) was reported. In addition, a mean 9-hours of tremor reduction was noted (14-hours at Baseline, 6.9-hours at 6-months) in a typical day at 6-months. All subjects (100%) reported mild disability, and no subject reported moderate or marked disability (89% at baseline) as reported by TRS at 6 months. CONCLUSIONS: This work represents the first comprehensive, large scale collection of real-world outcomes and evaluation of safety and effectiveness of a multiple-source, constant-current DBS system capable of providing directionality for use in treatment of Essential Tremor.

General anesthesia and femoral nerve block versus spinal anesthesia for cemented hip arthroplasty in elderly patients: A randomized controlled trial

ABSTRACT BACKGROUND Traumatic femoral fractures are a prevalent orthopaedic issue in elderly adults. General anaesthesia (GA) vs. spinal anaesthesia are still being discussed as the best anaesthetic method for cemented hip arthroplasty (SA). This study compared the impact of spinal anaesthesia versus general anaesthesia in combination with femoral nerve block on the mean arterial blood pressure (MAP) in patients having cemented hip arthroplasty operations. AIM OF THE STUDY To compare the impact of spinal anaesthesia on elderly patients undergoing cemented hip arthroplasty operations versus general anaesthesia in combination with femoral nerve block on mean arterial blood pressure. PATIENTS AND METHODS The study was registered at Pan African-Clinical Trial Registry.org with ID of (PACTR 202,111,575,647,784). At Ain Shams University Hospital, 60 patients receiving total hip arthroplasty were separated into two equal groups, each comprising 30 patients, for the purpose of this prospective randomised comparison study. Patients in Group (A) underwent spinal anaesthesia, while Group (B) received general anaesthesia together with an ultrasound-guided femoral nerve block. RESULTS This study showed that GA was associated with more stable readings of mean arterial blood pressure (MAP) after anesthesia induction and post cement implantation than SA (p-value = 0.04 and 0.038 respectively). CONCLUSION Patients who received general anesthesia (GA) had more stable hemodynamic parameters especially the mean arterial blood pressure (MAP) than those who received spinal anesthesia (SA).

Physiologic Cyclical Load on Inguinal Hernia Scaffold ProFlor Turns Biological Response into Tissue Regeneration

Surgical repair of groin protrusions is one of the most frequently performed procedures. Currently, open or laparoscopic repair of inguinal hernias with flat meshes deployed over the hernial defect is considered the gold standard. However, fixation of the implant, poor quality biologic response to meshes and defective management of the defect represent sources of continuous debates. To overcome these issues, a different treatment concept has recently been proposed. It is based on a 3D scaffold named ProFlor, a flower shaped multilamellar device compressible on all planes. This 3D device is introduced into the hernial opening and, thanks to its inherent centrifugal expansion, permanently obliterates the defect in fixation-free fashion. While being made of the same polypropylene material as conventional hernia implants, the 3D design of ProFlor confers a proprietary dynamic responsivity, which unlike the foreign body reaction of flat/static meshes, promotes a true regenerative response. A long series of scientific evidence confirms that, moving in compliance with the physiologic cyclical load of the groin, ProFlor attracts tissue growth factors inducing the development of newly formed muscular, vascular and nervous structures, thus re-establishing the inguinal barrier formerly wasted by hernia disease. The development up to complete maturation of these highly specialized tissue elements was followed thanks to biopsies excised from ProFlor from the short-term up to years post implantation. Immunohistochemistry made it possible to document the concurrence of specific growth factors in the regenerative phenomena. The results achieved with ProFlor likely demonstrate that modifying the two-dimensional design of hernia meshes into a 3D outline and arranging the device to respond to kinetic stresses turns a conventional regressive foreign body response into advanced probiotic tissue regeneration.

Electrode impedances in children with cochlear implants: Comparison between intra-operative Switch ON and post-operative Switch ON

Introduction Intra-operative Switch ON (IOSO) is a novel clinical approach of activating the cochlear implant during the surgery adopted at our cochlear implantation center.We compared the electrode impedances in two conditions of Switch ON of cochlear implants; IOSO and post-operative Switch ON (POSO, 21st day of surgery). Methods Electrode impedances of 185 cochlear implants, 93 of whom received IOSO and 92 POSO, recorded over 10 years were analyzed retrospectively. Results Electrode impedances of IOSO group were significantly lower than POSO group at Switch ON and 3rd, 6th, 9th, and 12th months post cochlear implantation. In IOSO group, 3rd month’s electrode impedances were high when compared to electrode impedances at Switch ON. Beyond the 3rd months, electrode impedance remained unchanged. In POSO group, there were no significant differences in electrode impedances between any measurement schedule. Conclusions To our knowledge, this is the first study to investigate in detail the electrode impedances of the two above-said conditions of Switch ON in the process of cochlear implantation. This study concludes that timing of CI Switch ON has a significant effect on the electrode impedances. These results may affect the choice of cochlear implant Switch ON timing.

Changes in frontal plane kinematics over 12-months in individuals with the Percutaneous Osseointegrated Prosthesis (POP).

A bone-anchored prosthesis (BAP) eliminates the need for a conventional socket by attaching a prosthesis directly to the user's skeleton. Currently, limited research addresses changes in gait mechanics post BAP implantation. Examine changes in frontal plane movement patterns after BAP implantation. Participants were individuals with unilateral transfemoral amputation (TFA) enrolled in the US Food and Drug Administration (FDA) Early Feasibility Study examining the Percutaneous Osseointegrated Prosthesis (POP). The participants completed overground gait assessments using their conventional socket and at 6-weeks, 12-weeks, 6-months, and 12-months following POP implantation. Statistical parameter mapping techniques were used in examining changes in frontal plane kinematics over the 12-months and differences with reference values for individuals without limb loss. Statistically significant deviations were found pre-implantation compared to reference values for hip and trunk angles during prosthetic limb stance phase, and for pelvis and trunk relative to the pelvis angles during prosthetic limb swing. At 6-weeks post-implantation, only the trunk angle demonstrated a statistically significant reduction in the percent of gait cycle with deviations relative to reference values. At 12-months post-implantation, results revealed frontal plane movements were no longer statistically different across the gait cycle for the trunk angle compared to reference values, and less of the gait cycle was statistically different compared to reference values for all other frontal plane patterns analyzed. No statistically significant within-participant differences were found for frontal plane movement patterns between pre-implantation and 6-weeks or 12-months post-implantation. Deviations from reference values displayed prior to device implantation were reduced or eliminated 12-months post-implantation in all frontal plane patterns analyzed, while within-participant changes over the 12-month period did not reach statistical significance. Overall, the results suggest the transition to a BAP aided in normalizing gait patterns in a sample of relatively high functioning individuals with TFA.

The use of deformation imaging in the assessment of patients pre and post transcatheter aortic valve implantation

BackgroundDeformation imaging represents a method of measuring myocardial function, including global longitudinal strain (GLS), peak atrial longitudinal strain (PALS) and radial strain. This study aimed to assess subclinical improvements in left ventricular function in patients undergoing transcatheter aortic valve implantation (TAVI) by comparing GLS, PALS and radial strain pre and post procedure.MethodsWe conducted a single site prospective observational study of 25 patients undergoing TAVI, comparing baseline and post-TAVI echocardiograms. Individual participants were assessed for differences in GLS, PALS and radial strain in addition to changes in left ventricular ejection fraction (LVEF) (%).ResultsOur results revealed a significant improvement in GLS (mean change pre-post of 2.14% [95% CI 1.08, 3.20] p = 0.0003) with no significant change in LVEF (0.96% [95% CI − 2.30, 4.22], p = 0.55). There was a statistically significant improvement in radial strain pre and post TAVI (mean 9.68% [95% CI 3.10, 16.25] p = 0.0058). There was positive trend towards improvements in PALS pre and post TAVI (mean change of 2.30% [95% CI − 0.19, 4.80] p = 0.068).ConclusionIn patients undergoing TAVI, measuring GLS and radial strain provided statistically significant information regarding subclinical improvements in LV function, which may have prognostic implications. The incorporation of deformation imaging in addition to standard echocardiographic measurements may have an important role in guiding future management in patients undergoing TAVI and assessing response.

Polydopamine (PDA) coatings with endothelial vascular growth factor (VEGF) immobilization inhibiting neointimal formation post zinc (zn) wire implantation in rat aortas

BackgroundBioresorbable stents are designed to provide temporary mechanical support to the coronary arteries and then slowly degrade in vivo to avoid chronic inflammation. Zinc (Zn) is a promising material for bioresorbable stents; However, it can cause inflammation and neointimal formation after being implanted into blood vessels.MethodsTo improve biocompatibility of Zn, we first coated it with polydopamine (PDA), followed by immobilization of endothelial vascular growth factor (VEGF) onto the PDA coatings. Adhesion, proliferation, and phenotype maintenance of endothelial cells (ECs) on the coated Zn were evaluated in vitro. Then, a wire aortic implantation model in rats mimicking endovascular stent implantation in humans was used to assess vascular responses to the coated Zn wires in vivo. Thrombosis in aortas post Zn wire implantation, degradation of Zn wires in vivo, neointimal formation surrounding Zn wires, and macrophage infiltration and extracellular matrix (ECM) remodeling in the neointimas were examined.ResultsIn vitro data showed that the PDA-coated Zn encouraged EC adhesion, spreading, proliferation, and phenotype maintenance on its surfaces. VEGF functionalization on PDA coatings further enhanced the biocompatibility of Zn to ECs. Implantation of PDA-coated Zn wires into rat aortas didn’t cause thrombosis and showed a faster blood flow than pure Zn or the Zn wires coated with VEGF alone. In addition, the PDA coating didn’t affect the degradation of Zn wires in vivo. Besides, the PDA-coated Zn wires reduced neointimal formation, increased EC coverage, decreased macrophage infiltration, and declined aggrecan accumulation in ECM. VEGF immobilization onto PDA coatings didn’t cause thrombosis and affect Zn degradation in vivo as well, and further increased the endothelization percentage as compared to PDA coating alone, thus resulting in thinner neointimas.ConclusionThese results indicate that PDA coatings with VEGF immobilization would be a promising approach to functionalize Zn surfaces to increase biocompatibility, reduce inflammation, and inhibit neointimal formation after Zn implantation in vivo.Graphical

Mechanical strain induces ex vivo expansion of periosteum.

Segmental bone defects present complex clinical challenges. Nonunion, malunion, and infection are common sequalae of autogenous bone grafts, allografts, and synthetic bone implants due to poor incorporation with the patient's bone. The current project explores the osteogenic properties of periosteum to facilitate graft incorporation. As tissue area is a natural limitation of autografting, mechanical strain was implemented to expand the periosteum. Freshly harvested, porcine periosteum was strained at 5 and 10% per day for 10 days with non-strained and free-floating samples serving as controls. Total tissue size, viability and histologic examination revealed that strain increased area to a maximum of 1.6-fold in the 10% daily strain. No change in tissue anatomy or viability via MTT or Ki67 staining and quantification was observed among groups. The osteogenic potential of the mechanical expanded periosteum was then examined in vivo. Human cancellous allografts were wrapped with 10% per day strained, fresh, free-floating, or no porcine periosteum and implanted subcutaneously into female, athymic mice. Tissue was collected at 8- and 16-weeks. Gene expression analysis revealed a significant increase in alkaline phosphatase and osteocalcin in the fresh periosteum group at 8-weeks post implantation compared to all other groups. Values among all groups were similar at week 16. Additionally, histological assessment with H&E and Masson-Goldner Trichrome staining showed that all periosteal groups outperformed the non-periosteal allograft, with fresh periosteum demonstrating the highest levels of new tissue mineralization at the periosteum-bone interface. Overall, mechanical expansion of the periosteum can provide increased area for segmental healing via autograft strategies, though further studies are needed to explore culture methodology to optimize osteogenic potential.