Prospective Case Series Research Articles

Head-to-head comparisons of enhanced CT, 68Ga-PSMA-11 PET/CT and 18F-FDG PET/CT in identifying adverse pathology of clear-cell renal cell carcinoma: a prospective study.

Accurate preoperative prediction of adverse pathology is crucial for treatment planning of renal cell carcinoma (RCC). Previous studies have emphasized the potential of prostate-specific membrane antigen positron emission tomography / computed tomography (PSMA PET/CT) in differentiating between benign and malignant localized renal tumors. However, there is a scarcity of case reports elucidating the identification of aggressive pathological features using PET/CT. Our study was designed to prospectively compare the diagnostic value of enhanced CT, 68Ga-PSMA-11 and 18F-fluorodeoxyglucose (18F-FDG) PET/CT in clear-cell renal cell carcinoma (ccRCC) with necrosis or sarcomatoid or rhabdoid differentiation. A prospective case series of patients with a newly diagnosed renal mass who underwent enhanced CT, 68Ga-PSMA-11 and 18F-FDG PET/CT within 30 days prior to nephrectomy was included. Complete preoperative and postoperative clinicopathological data were recorded. Patients who received neoadjuvant targeted therapy, declined enhanced CT or PET/CT scanning, refused surgical treatment or had non-ccRCC pathological indications were excluded. Radiological parameters were compared within subgroups of pathological characteristics. Bonferroni corrections were used to adjust for multiple testing and statistical significance was set at a p-value less than 0.017. Seventy-two patients were available for the final analysis. Enhanced CT demonstrated poor performance in identifying necrosis, sarcomatoid or rhabdoid differentiation and adverse pathology (all P > 0.05). The maximum standardized uptake value (SUVmax) of 68Ga-PSMA-11 PET/CT was more effective than 18F-FDG PET/CT in identifying tumor necrosis and adverse pathology, with an area under the curve (AUC) of 0.85 (cutoff value=25.26, p<0.001; Delong test z=2.709, p=0.007) for tumor necrosis and AUC of 0.90 (cutoff value=25.26, p<0.001; Delong test z=3.433, p<0.001) for adverse pathology. However, no significant statistical difference was found between 68Ga-PSMA-11 and 18F-FDG PET/CT in predicting sarcomatoid or rhabdoid feature (AUC of 0.91 vs.0.75, Delong test z=1.998, p=0.046). Subgroup analyses based on age, sex, tumor location, maximal diameter, stage and WHO/ISUP grade demonstrated that 68Ga-PSMA-11 PET/CT SUVmax had a significant predictive value for adverse pathology. Enhanced CT value and SUVmax demonstrated strong reliability [intraclass correlation coefficient (ICC) > 0.80], indicating a robust correlation. 68Ga-PSMA-11 PET/CT demonstrates distinct advantages in identifying aggressive pathological features of primary ccRCC when compared to enhanced CT and 18F-FDG PET/CT. Further research and assessment are warranted to fully establish the clinical utility of 68Ga-PSMA-11 PET/CT in ccRCC.

Clinical Outcomes of Femtosecond Laser-assisted Implantation of 325-Degree Versus 340-Degree Arc Length Intracorneal Ring Segments in Naive Keratoconic Eyes.

To evaluate and compare clinical outcomes after femtosecond laser-assisted implantation of 325-degree versus 340-degree arc length intracorneal ring segments (ICRS) in eyes with keratoconus (KCN). In this prospective non-randomized interventional case series, 23 eyes of 21 patients diagnosed with KCN, underwent femtosecond laser-assisted implantation of two types of ICRS, which included a 325-degree ICRS (Group 325) and a 340-degree ICRS (Group 340). The primary outcome measures were uncorrected distance visual acuity (UDVA), and the secondary outcome measures included corrected distance visual acuity (CDVA), sphere, cylinder, mean refractive spherical equivalent (MRSE), keratometry, vectorial change in corneal astigmatism, and the location of maximum keratometry relative to the corneal apex. The study groups were compared using the primary and secondary outcome measures obtained at postoperative months six and 12. Groups 325 and 340 consisted of 10 and 13 eyes, respectively. The two groups were comparable in terms of parameters measured preoperatively. On comparison to the baseline values, both study groups exhibited a significant increase in UDVA and CDVA measured at postoperative month six (Ps 0.05) and a significant decrease in the sphere, cylinder, spherical equivalent refraction, and keratometry readings measured at postoperative months six and 12 (Ps 0.05). No significant differences were observed between the two groups in terms of visual, refractive, and keratometric outcomes at any time point. No intraoperative or postoperative complications were observed in any of the study groups. Both the 325-degree ICRS and the 340-degree ICRS effectively and equally improved visual, refractive, and keratometric outcomes in keratoconic eyes.

Posttraumatic arthritis and functional outcomes of nonoperatively treated distal radius fractures after 3 years

Recent studies have shown that distal radius fractures (DRFs) in elderly patients can be treated nonoperatively with good functional results after 1 year. However, scientific evidence regarding longer follow-up to assess posttraumatic arthritis (PA), complications, and functional outcomes is scarce. This prospective case series aimed to evaluate these outcomes in a cohort of patients ≥ 65-year-old with nonoperatively treated DRFs after a minimum of 3 years. The primary outcome was PA. Secondary outcomes were complications, Quick Disabilities of the Arm, Shoulder and Hand Outcome Measure (QuickDASH), Patient-Rated Wrist/Hand Evaluation (PRWHE), pain, range of motion and grip strength. The full data of 32 patients with a mean follow-up of 3.3 years were available: 10/32 patients had radiological signs of PA, but only 2 of these patients reported pain. A total of 11/32 fractures healed in malunion (> 10° dorsal angulation). There was no significant difference in QuickDASH or PRWHE from 1 year to the latest follow-up after more than 3 years. This study thus adds to the literature stating that radiological signs, including PA and malunion, do not necessarily result in symptoms. Moreover, it underpins that nonoperative treatment of these patients results in good functional outcomes after 1 and 3 years.

ASSOCIATION OF INTRAVENOUS FLUORESCEIN ANGIOGRAPHY AND ADAPTIVE OPTICS IMAGING IN DIABETIC RETINOPATHY: A Prospective Case Series.

To our knowledge, we present the first case series investigating the relationship between adaptive optics (AO) imaging and intravenous fluorescein angiography (IVFA) parameters in patients with diabetic retinopathy. Consecutive patients with diabetic retinopathy older than age 18 years presenting to a single center in Toronto, Canada, from 2020 to 2021 were recruited. Adaptive optics was performed with the RTX1 camera (Imagine Eyes, Orsay, France) at retinal eccentricities of 2° and 4°. Intravenous fluorescein angiography was assessed with the artificial intelligence-based RETICAD system to extract blood flow, perfusion, and blood-retinal-barrier (BRB) permeability at the same retinal locations. Correlations between AO and IVFA parameters were calculated using Pearson's correlation coefficient. Across nine cases, a significant positive correlation existed between photoreceptor spacing on AO and BRB permeability (r = 0.303, P = 0.027), as well as perfusion (r = 0.272, P = 0.049) on IVFA. When stratified by location, a significant positive correlation between photoreceptor dispersion and both BRB permeability and perfusion (r = 0.770, P = 0.043; r = 0.846, P = 0.034, respectively) was observed. Cone density was also negatively correlated with BRB permeability (r = -0.819, P = 0.046). Photoreceptor spacing on AO was significantly correlated with BRB permeability and perfusion on IVFA in patients with diabetic retinopathy. Future studies with larger sample sizes are needed to understand the relationship between AO and IVFA parameters in diverse patient populations.

A prospective study to evaluate incidence and risk factor for surgical site infection in patient undergoing abdominal surgeries at a tertiary care centre of Western Rajasthan

Background: Study was conducted to evaluate the incidence, risk factors, identification of etiological agents, and antimicrobial sensitivity and resistance for surgical site infections in patients undergoing abdominal surgeries at Mathura Das Mathur Hospital, Jodhpur. Methods: A prospective case series study was conducted at Mathura Das Mathur Hospital, Jodhpur, Rajasthan, involving all patients undergoing abdominal surgeries between 1 January 2021 and 1 January 2022. Patient demographics and associated risk factors were documented, and comprehensive investigations were carried out. Results: This study included 220 patients, with an infection rate of 18.6%. Compared to other studies conducted in India, this rate is almost similar. However, studies conducted in the Western world show a lower infection rate. Conclusions: The incidence of surgical site infection in this study was 18.6%, which is comparable to other studies conducted in India. Pseudomonas was the most commonly isolated organism, and older individuals were found to be more susceptible to infection. Risk factors such as diabetes mellitus, respiratory tract infection, urinary tract infection, emergency surgeries, and higher BMI also contributed to the development of surgical site infections.

Outcomes of perichondrium graft covering the epithelium of the tympanic membrane for large-sized perforations: A 3–5-year follow-up study

ObjectiveThe objective of this study was to evaluate the graft outcomes and iatrogenic cholesteatomas for 3 years following cartilage-perichondrium over-underlay technique with perichondrial graft covering the epithelium for large-sized tympanic membrane (TM) perforations. Materials and methodsThis prospective case series enrolled patients with large-sized perforation who underwent endoscopic cartilage-perichondrium over-underlay technique. The graft success rate, hearing outcomes, and development of iatrogenic middle ear cholesteatomas and graft cholesteatomas were assessed at 3 years postoperatively. ResultsThis study included 62 ears of 62 patients. The mean follow-up duration was 47.3 ± 10.8 (38–64) months. Neovascularization was observed in the lateral perichondrium graft in 55 (88.7 %) patients, which inosculated into the TM remnant at 4–5 weeks. However, graft neovascularization was not observed in the four patients with excessive perichondrium graft that migrated into the external auditory canal and the three patients with middle ear infections. The graft failure rate was 6.5 % at 6 months, 11.3 % at 12 months, 6.5 % at 24 months, and the overall graft success rate was 91.8 % at the last follow-up. Granular myringitis developed in 11.3 % (7/62) of the patients. High-resolution computed tomography revealed well-pneumatized mastoids and middle ear at the final follow-up. However, graft cholesteatomas were observed in 3 (4.8 %) patients at 7–24 months postoperatively. ConclusionsThe cartilage-perichondrium over-underlay technique with perichondrial graft covering TM epithelium is safe and effective for the repair of large perforations, with good short- and long-term graft outcomes, minimal risk of graft cholesteatoma development, and no risk of iatrogenic middle ear cholesteatomas.

Clinical Features of Quail Egg Ingestion in Patients with Acquired Tolerance to Hen Eggs: A Case Series Study

Introduction: Patients with hen’s egg allergy are often instructed to avoid consuming other avian eggs, such as quail eggs. However, it is unclear whether patients with an acquired tolerance to hen eggs continue to avoid consuming quail eggs. This study aimed to evaluate the clinical features of quail egg ingestion. Methods: This prospective case series included children aged ≥1 year with hen’s egg allergy who were recruited between October 2019 and February 2021 in our hospital. We conducted an oral food challenge (OFC) with three boiled quail eggs to evaluate the clinical features of quail egg ingestion in patients with acquired tolerance to hen eggs. The primary outcome was a positive OFC after ingesting three quail eggs. Secondary outcomes were cross-antigenicity between hen and quail eggs observed through the skin prick test (SPT) and pattern of quail egg allergy, comprising the onset of reaction, and severity. The correlation between the diameters of the wheals with SPT in hen and quail eggs was evaluated using the Pearson product-moment correlation coefficient. Results: A total of 62 patients underwent the quail egg OFC. The median (interquartile range) age of the participants was 3 (2–5) years. Thirty-three (53%) patients had a history of anaphylaxis due to hen eggs. The median total immunoglobulin E (IgE) level in patients who underwent the OFC with half a heated whole hen’s egg was 271 (98–593) IU/mL. The median specific IgE level in egg white and ovomucoid was 9.7 (3.2–21.5) and 4.4 (1.3–6.9) UA/mL, respectively. The quail egg OFC results revealed that none of the 59 patients who ate the three quail eggs completely had an allergic reaction. The SPT-positive and SPT-negative rates in raw and boiled hen and quail egg whites were both correlated. The diameters of wheals with SPT in raw hen and quail egg whites and yolks were positively correlated. Conclusion: Patients with an acquired tolerance to hen eggs may not be required to avoid consuming quail eggs.

Customized corneal allogenic intrastromal ring segments (CAIRS) for keratoconus with decentered asymmetric cone.

Corneal allogenic intrastromal ring segments (CAIRS) refer to the intracorneal placement of fresh, unprocessed, processed, preserved, or packaged allogenic rings/segments of any type/length. We described uniform-thickness CAIRS previously. We now describe a new technique of customized CAIRS to personalize the flattening effect as per individual topography. A prospective interventional case series of patients with pericentral/ paracentral decentered cones and gradation of keratometry with one side steeper than the other was conducted. Individually customized tapered CAIRS with variable volume, arc length, taper length, and gradient of taper were implanted. In total, 32 eyes of 29 patients with at least 1-year follow-up were included. Special double-bladed trephines and a CAIRS customizer template allowed the creation of individually customized CAIRS. Mean uncorrected distance visual acuity (UDVA) and spectacle-corrected distance visual acuity improved from 0.22 to 0.47 (P = 0.000) and from 0.76 to 0.89 (P = 0.001), respectively. Significant improvement was seen in K1, K2, Km, Kmax, topographic astigmatism, Q-value, sphere, cylinder, spherical equivalent, Root Mean Square (RMS), Higher Order Aberrations (HOA), and vertical coma (P < 0.01, 0.05). There was no significant change in the width or height of CAIRS between 1 month and last visit on anterior-segment optical coherence tomography. Five eyes continued to remain at the same UDVA, 27 eyes had at least 2 lines, and 13 eyes had at least 3 or more lines improvement in UDVA. The maximum improvement in UDVA was 7 lines. A significant difference in flattening was obtained at different zones across the tapered CAIRS. Thus, differential flattening was achieved across the cone based on the customization plan. Personalized customization was possible for each cornea, unlike limited models of progressive-thickness synthetic segments. Allogenic nature, greater customizability, efficacy, and absent need for large inventories are advantages compared to synthetic segments.

Prevalence of serum MOG antibody and AQP4 antibody in optic neuritis after SARS-CoV-2 infection.

To evaluate the prevalence of serum myelin oligodendrocyte glycoprotein antibody (MOG-Ab) and aquaporin-4 antibody (AQP4-Ab) in optic neuritis (ON) patients after severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection by cell-based indirect immunofluorescence assay (CBA). In this prospective case series study, 35 patients clinically diagnosed as ON and laboratory-confirmed SARS-CoV-2 infection from 8 December 2022 to 8 February 2023 were included. All patients' clinical and laboratory data were collected and analyzed. The mean age of the 35 patients (46 eyes) was 38.2 years (ranging from 6 to 69 years), and 17 cases were female patients. Thirty-three and two cases showed positive SARS-CoV-2 RNA test results before or shortly after ON onset, respectively. ON occurred unilaterally in 24 cases and bilaterally in 11 cases. Ophthalmic examination revealed swollen optic disc in 37 eyes, normal optic disc in 6 eyes, and temporally or wholly paled optic disc in 3 eyes. CBA revealed seropositive MOG-Ab in 10 cases and AQP4-Ab in 2 cases, respectively, of which 2 AQP4-Ab-seropositive cases and 1 MOG-Ab-seropositive case had a past medical history of ON. Most ON patients showed a rapid and dramatic response to pulse steroid therapy. The median of BCVA at the onset and at the last follow-up was 20/500 (ranging from light perception to 20/20) and 20/67 (ranging from counting fingers to 20/20), respectively. Serum MOG-Ab and AQP4-Ab were detected in 28.6% (10/35) and 5.7% (2/35) ON cases after SARS-CoV-2 infection. SARS-CoV-2 infection may trigger an onset or a relapse of ON, as well as the production of MOG-Ab.

Progression of PROM1-Associated Retinal Degeneration as Determined by Spectral-Domain Optical Coherence Tomography Over a 24-Month Period

PurposeTo evaluate the progression of atrophy as determined by spectral-domain optical coherence tomography (SD-OCT) in patients with molecularly confirmed PROM1-associated retinal degeneration (RD) over a 24 months period. DesignInternational, multicenter, prospective case series. MethodsA total of 13 eyes (13 patients) affected with PROM1-associated RD were enrolled at five sites and SD-OCT images were obtained at baseline and after 24 months. Loss of mean thickness (MT) and intact area were estimated after semi-automated segmentation for the following individual retinal layers in the central subfield (CS), inner ring and outer ring of the ETDRS grid: retinal pigment epithelium (RPE), outer segments (OS), inner segments (IS), outer nuclear layer (ONL), inner retina (IR), and total retina (TR). ResultsStatistically significant losses of thickness of RPE and TR were detected in the CS and inner ring and of ONL and IS in the outer ring (all p<0,05); a statistically significant decrease of intact area of RPE and IS was observed in the inner ring and of ONL in the outer ring (all p<0,05); the change in MT and the intact area of the other layers showed a trend of decline over an observational period of 24 months. ConclusionsSignificant thickness losses could be detected in outer retinal layers by SD-OCT over a 24 months period in patients with PROM1-associated retinal degeneration. Loss of thickness and/or intact area of such layers may serve as potential endpoints for clinical trials that aim to slow down the disease progression of PROM1-associated retinal degeneration.

Efficacy and safety of acupuncture treatment for fatigue after COVID-19 infection: study protocol for a pilot randomized sham-controlled trial.

As the coronavirus disease 2019 (COVID-19) pandemic has spread globally, its sequelae, called Long COVID, have persisted, troubling patients worldwide. Although fatigue is known to be the most frequent among Long COVID symptoms, its mechanism and treatment have not been clearly demonstrated. In 2022, we conducted a preliminary prospective case series and found that acupuncture and moxibustion were feasible interventions for fatigue. This study is a pilot patient-assessor-blinded randomized sham-controlled trial to evaluate the efficacy and safety of acupuncture treatment for patients with fatigue that has persisted for at least 4 weeks after recovery from COVID-19. Thirty patients will be recruited and randomly assigned to either the acupuncture or sham acupuncture treatment groups. Treatment will be conducted thrice a week for both groups during 4 weeks. The primary outcome will be the efficacy and safety of acupuncture, including numeric rating scale (NRS), brief fatigue inventory (BFI), fatigue severity scale (FSS), and adverse event evaluation. Secondary outcomes will be evaluation of improvement in the comorbid symptoms of fatigue and feasibility variables. Outcome variables will be assessed before treatment, 4 weeks after treatment, and 8 weeks after treatment completion. The results of this study will be used to clarify the efficacy and safety of acupuncture treatment for persistent fatigue in patients with Long COVID. Additionally, the feasibility of the study design was validated to provide evidence for future full-scale randomized controlled trials.Clinical trial registration: identifier: KCT0008656 https://cris.nih.go.kr/cris/search/detailSearch.do?seq=24785&search_page=L.

Salpingo-Oophorectomy During Non-Descent Vaginal Hysterectomy Using the Paily Vaginal Oophorectomy Clamp

We conducted a 6-year prospective surgical case series study at a tertiary care centre in South India to evaluate the safety and efficacy of the novel Paily Vaginal Oophorectomy Clamp and its unique application technique during non-descent vaginal hysterectomy requiring salpingo-oophorectomy. The Paily Vaginal Oophorectomy Clamp’s reversed blade design allows direct and secure grasping of the infundibulopelvic ligament as there is no intervening tissue near the joint, reducing the risk of slippage. In contrast, while using conventional clamps such as Heaney's, infundibulopelvic slippage occurs due to the presence of tissue between blades near the joint. A demonstration video is provided (Video).

Clinical Utility Assessment of a Nursing Checklist Identifying Complex Care Needs Due to Inequities Among Ambulatory Patients With Cancer: Protocol for a Mixed Methods Study.

Disparities in cancer incidence, complex care needs, and poor health outcomes are largely driven by structural inequities stemming from social determinants of health. To date, no evidence-based clinical tool has been developed to identify newly diagnosed patients at risk of poorer outcomes. Specialist cancer nurses are well-positioned to ameliorate inequity of opportunity for optimal care, treatment, and outcomes through timely screening, assessment, and intervention. We designed a nursing complexity checklist (the "Checklist") to support these activities, with the ultimate goal of improving equitable experiences and outcomes of care. This study aims to generate evidence regarding the clinical utility of the Checklist. The primary objectives of this study are to provide qualitative evidence regarding key aspects of the Checklist's clinical utility (appropriateness, acceptability, and practicability), informed by Smart's multidimensional model of clinical utility. Secondary objectives explore the predictive value of the Checklist and concordance between specific checklist items and patient-reported outcome measures. This prospective mixed methods case series study will recruit up to 60 newly diagnosed patients with cancer and 10 specialist nurses from a specialist cancer center. Nurses will complete the Checklist with patient participants. Within 2 weeks of Checklist completion, patients will complete 5 patient-reported outcome measures with established psychometric properties that correspond to specific checklist items and an individual semistructured interview to explore Checklist clinical utility. Interviews with nurses will occur 12 and 24 weeks after they first complete a checklist, exploring perceptions of the Checklist's clinical utility including barriers and facilitators to implementation. Data describing planned and unplanned patient service use will be collected from patient follow-up interviews at 12 weeks and the electronic medical record at 24 weeks after Checklist completion. Descriptive statistics will summarize operational, checklist, and electronic medical record data. The predictive value of the Checklist and the relationship between specific checklist items and relevant patient-reported outcome measures will be examined using descriptive statistics, contingency tables, measures of association, and plots as appropriate. Qualitative data will be analyzed using a content analysis approach. This study was approved by the institution's ethics committee. The enrollment period commenced in May 2022 and ended in November 2022. In total, 37 patients with cancer and 7 specialist cancer nurses were recruited at this time. Data collection is scheduled for completion at the end of May 2023. This study will evaluate key clinical utility dimensions of a nursing complexity checklist. It will also provide preliminary evidence on its predictive value and information to support its seamless implementation into everyday practice including, but not limited to, possible revisions to the Checklist, instructions, and training for relevant personnel. Future implementation of this Checklist may improve equity of opportunity of access to care for patients with cancer. DERR1-10.2196/48432.

Functional and radiographic assessments of post-traumatic asymmetrical ankle osteoarthritis treatment using supramalleolar osteotomies

PurposeThis study's objective is to assess the effectiveness of supramalleolar osteotomies (SMOT) in the treatment of asymmetrical ankle osteoarthritis in terms of the improvement in alignment assessed radiographically and its impact on symptoms measured by the American Orthopedic Foot and Ankle Society ankle–hindfoot score (AOFAS ankle–hindfoot score).MethodsTwelve patients participated in this prospective observational case series study. Standing anteroposterior, true lateral, and mortise views radiographs were taken. For preoperative planning, the lateral distal tibial angle (LDTA), talar tilt (TT), talocrural angle (TCA), and anterior distal tibial angle (ADTA) were all measured. A medial opening wedge osteotomy mainly was used to treat the varus arthritis ankle. A further oblique fibular osteotomy is frequently necessary.ResultsThe male-to-female ratio was 3:1, and the mean age of the patients was 26.25 ± 13.032 years. There were highly statistically significant differences between pre-and post-operative AOFAS ankle–hindfoot score (p < 0.001). Statistically significant differences concerning ankle range of motion (p = 0.002, < 0.001) of dorsiflexion and planter flexion were detected. Comparison between pre-and post-operative patients' radiology characteristics shows statistically significant differences concerning TT (p = 0.016) and LDTA (p = 0.046).ConclusionSMOT is very effective in the treatment of post-traumatic ankle osteoarthritis and postpones ankle fusion or total ankle replacements. This surgery significantly improves functional and radiological outcomes as well as the range of motion in the ankle. Meticulous preoperative planning by radiological measurements of different angles around the ankle is considered the crucial factor in success of that operation.

Abstract 12595: Vascular and Cardiac Ultrasound as the Primary Imaging Tool to Safely Deliver Pacing Leads While Implanting Single Chamber Cardiac Implantable Electronic Devices. RADICAI USE Investigators

Introduction: Conventional Cardiac implantable electronic devices (CIEDs) implantation requires fluoroscopy. Risks involved with implantation include pneumothorax, lead dislodgement, and perforation of the right ventricular wall. In addition, there are long-term risks of malignancy associated with prolonged and repeated use of radiation over the decades of operators’ employment and mechanical injuries related to heavy personal protection equipment. To reduce these risks, we aimed to study the utilization and safety of ultrasound (US) for the entire procedure to implant single-chamber devices. Methods: The RADICAI USE study (Reduction or Elimination of Radiation Use in Single Chamber Cardiac Devices using ultrasound) is a prospective, single-arm and multi-operator case series enrolled patients awaiting a single-chamber CIED. A fluoroscopic cut-off time of 20 seconds was used to define the success (Group A) or failure (Group B) of using the US for the entire implant duration. Patients were followed up at 1 week, 1 month and 1-year post-implant. Results: The study enrolled 63 patients, with 50 pacemakers and 13 ICDs, a mean age of 79.5 ± 13.8 years (95% CI = 76.1 - 82.9), and a mean weight of 74.1 ± 14.6 (95% CI = 70.5 - 77.7). Overall, 53 (84.1%) CIEDs were successfully implanted with a radiation time of less than 20 seconds (Group A). Fluoroscopic over 20 seconds was required due to poor echocardiographic windows, challenging access, or anatomy. No iatrogenic new or worsening of tricuspid regurgitation was noted. The mean procedure time including US setup time was 65.2 ± 20.2 (95% CI = 60.2 -70.2) minutes. Fluoroscopic time was significantly reduced in Group A compared to Group B (5.8 ± 4.5s vs 109.5 ± 92.9s, p = 0.004). Follow-up showed no device-related complications, with only two patients requiring lead revisions due to poor sensitivity, one unrelated to US use and another probably related. Conclusions: US-guided implantation of single-chamber CIEDs is feasible and safe, reducing the need for fluoroscopic guided implantation and subsequent risks of higher radiation exposure. Further studies are required to evaluate the cost-effectiveness and to explore fluoroscopic-free single-chamber CIED implantations using the US.

Clinical outcomes of endoscopic dacryocystorhinostomy without preserving mucosal flaps in combination with silicone stent and steroid-soaked gelfoam

To report clinical outcomes of endoscopic dacryocystorhinostomy (En-DCR) combined with stenting and without preserving the nasal and lacrimal mucosal flaps. In this prospective interventional case series, patients with primary acquired nasolacrimal duct obstruction who were candidates for En-DCR were enrolled. Patients with a known history of previous DCR, sinus surgery, rhinoplasty, nasal trauma, nasal anomaly, canalicular or punctal occlusion, or less than one year of follow-up were excluded. All patients underwent En-DCR and stenting followed by ostial packing using Gelfoam soaked with dexamethasone. The patients were assessed preoperatively, on the first postoperative day, after 2 weeks, 3 months, and 1 year. Postoperative outcomes were anatomical and functional success, defined as patent irrigation test and resolution of epiphora, respectively. The nasolacrimal drainage system was evaluated anatomically and functionally during the follow-up period. Eighty-three patients with a mean age of 54.36±15.27 years were enrolled. Of these, 61 patients (73.5%) were women. The mean duration of follow-up was 20.7±6.9 months. Anatomical success was achieved in all patients and remained stable during the study duration and at 1 year. Functional failure leading to epiphora was observed in 1 patient 3 months after surgery and resolved after re-DCR at year 1. Preoperative tenderness and purulent reflux were observed in 12%, 33.7% of which completely resolved postoperatively. Moderate and severe hemorrhage was observed in 12 (14.5%) and 2 (2.4%) patients, respectively. En-DCR without mucosal flap preservation in combination with silicone stent and steroid-soaked Gelfoam is a safe and highly successful procedure in patients with primary acquired nasolacrimal duct obstruction.

Arthroscopic biceps tenodesis using press-fit bony plug: a case series study.

To assess the feasibility, operative time, clinical outcomes, possible complications, and failure rates of all-through arthroscopic biceps tenodesis using press-fit bony plug technique. This prospective case series study involved 30 skeletally mature patients with long head of biceps pathology (tendinitis after failure of conservative treatment, subluxation, dislocation, or tendon tears). All patients were followed up for 24months at least. Twenty-nine patients regained full shoulder and elbow range of motion; one case suffered from reflex sympathetic dystrophy. There was a significant improvement in the constant, ASES, and VAS scores when comparing the pre-operative and post-operative values. The average biceps strength was 96% compared to the opposite healthy side. No cases were complicated by neuro-vascular deficits or failure of the tenodesis. Press-fit biceps tenodesis is safe and accessible with low economic demands. We recommend this technique to be used more often when addressing patients with long head of biceps pathologies. Registration number: N-1562023. Registration date: June 2022 "Retrospectively registered".

Treatment of Maxillary Gingival Recessions Using the Modified Coronally Advanced Tunnel Technique in Combination with a Volume-Stable Collagen Matrix: A Prospective Case Series with a 12-Month Follow-up

The aim of this case series was to evaluate the clinical performance of a new volume-stable collagen matrix (VCMX) in combination with the modified coronally advanced tunnel technique (MCAT) for the treatment of gingival recessions. Thirteen patients with a total of 33 maxillary RT1 single and multiple gingival recessions were included in the study. Probing pocket depth (PPD), recession width (RECW), recession depth (REC), height of keratinized tissue (HKT), and gingival thickness (GT) were assessed at baseline and at the 12-month follow-up. Postoperative healing was uneventful in all cases without any complications. At 12 months, mean root coverage (MRC) was 92.88%, with complete root coverage (CRC) in 87.88% of treated sites. The present findings suggest that VCMX in combination with MCAT results in predictable coverage of maxillary RT1 gingival recessions. Further studies with larger sample sizes and control groups are needed to support these preliminary outcomes.

Magnetic Resonance Imaging–Aided SmartFlow Convection Delivery of DNX-2401: A Pilot, Prospective Case Series

The Combination Adenovirus+ Pembrolizumab to Trigger Immune Virus Effects (CAPTIVE) study is a phase II clinical trial testing the efficacy of a recombinant adenovirus DNX-2401 combined with the immune checkpoint inhibitor pembrolizumab. Here, we report the first patients in this study who underwent viral delivery through real-time magnetic resonance imaging (MRI) stereotaxis-guided SmartFlow convection delivery of DNX-2401. Patients who underwent real-time MRI-guided DNX-2401 delivery through the SmartFlow convection catheter were prospectively followed. Precise catheter placement was achieved in all patients treated, and no adverse events were noted. Average radial error from target was 0.9 mm. Average procedural time was 3 hours 16 minutes and was comparable to other convection-enhanced delivery techniques. In 2 patients, delivery of DNX-2401 was visualized as >1 cm maximal diameter of T1 hypointensity infusate on MRI obtained immediately after completion of viral infusion. These patients exhibited partial response based on Response Assessment in Neuro-Oncology assessment. The remaining patient showed <1 cm maximal diameter of infusate on immediate postinfusion MRI and showed disease progression on subsequent MRI. Our pilot case series supports compatibility of the SmartFlow system with oncolytic adenovirus delivery and provides the basis for future validation studies.

Maxillary Sinus-Floor Augmentation by Porcine-Apatite Xenograft: A Prospective Case Series Study.

Bone substitutes sometimes are unsuccessful in replacing the autogenous bone graft, combining the advantages and disadvantages to achieve satisfactory results. The aim of this work was to clinically and histologically evaluate the outcome of porcine-apatite xenograft used to elevate the maxillary sinus floor in severe atrophy ridge. A two-stage crestal window sinus lift protocol was conducted in 24 patients with crestal bone ≤2mm. Highly porous porcine carbonate apatite moistened with saline solution was placed in the elevated sinus cavity as the sole grafting material. Bone core biopsies were taken at 6, 9 and 12 months after the sinus augmentation surgery at the time of implant placement. The treatment outcome was assessed using the μCT (micro computed tomogram) and histological analysis. Statistical analysis was performed using the nonparametric Kruskal-Wallis test, followed by the post-hoc Dunn multiple comparison test. At 6 months after implant placement, all implants achieved good primary stability (≥ 30 Ncm of insertion torque) and successfully osseointegrated. The residual graft amount (m±SE) was low (11.91±1.99%) at 6 months, and further decreased (6.11±2.64%) at 12 months after the sinus augmentation surgery. On the contrary, the amount of new bone detected was 18.94±4.08% at 6 months, and significantly (p<0.05) increased (40.16±5.27%) 12 months after sinus augmentation surgery. Histological assessment revealed existing of osteoclasts in resorbing the graft as well as the osteoblasts in forming the new bone. In the severely atrophic maxilla, the porcine-apatite xenograft promotes new bone formation while being slowly absorbed. In conclusion, within the limited sample size, the porcine-apatite xenograft seems to be a good material to be used as the graft material for crestal window sinus augmentation.