Postprocedural Research Articles

A novel bionic constructional left atrial appendage occlude device: the result of preclinical experiment and first-in-human study

Abstract Objectives Left atrial appendage occlusion (LAAO) has emerged as a viable substitute for oral anticoagulation (OAC) for stroke prevention among individuals with atrial fibrillation (AF) these years. The high variability of left atrial appendage (LAA) in different individuals would lead to failure of LAAO or significant PDL post procedure using the existing occluders. Therefore, novel occluder which could address these issues is of great urgent. Methods SimuLock® occluders were implanted in 18 healthy canines percutaneously. Angiography and transesophageal echocardiography were employed to evaluate the effect of closure. The canines were sacrificed post-procedure immediately or on 30th, 90th and 180th. Subsequently, the gross anatomy was examined and endothelialization of device surface was evaluated by HE staining. 3 patients who had non-valvular AF and underwent LAAO in Zhongshan hospital, Fudan University using SimuLock® were enrolled in this study. They all had a follow-up of 3 months. Results All animals were implanted with the SimuLock® device. In 27.8% of animal cases, a LAA occluder of the "large umbrella and small disc" type which could adapt to LAA morphology well was employed, and all surpassed the specifications of existing occluders. None of residual shunt was observed all canines in 180 days post procedure. In addition, none adverse events were documents during the 6-month follow-up. In the first-in-human study, the SimuLock® occluder were successfully implanted in 3 subjects, all subjects achieved complete occlusion, without residual shunt > 3mm. The incidence of major adverse events, operation-related serious adverse events and device-related serious adverse events in all subjects were not documented in 3 months after operation. Conclusions In the animal experiment and first-in-human study, SimuLock® device showed the ability of adapting to various LAA morphology well and rapid endothelialization. The utilization of SimuLock® for LAAO exhibited high efficacy and safety.Central figure

Feasibility of ultra-low volume contrast pulmonary arterial injection protocol for CTA in TAVI candidates with severe renal failure

Abstract Introduction Computer tomography angiography (CTA) has an important role in patient screening before TAVI. The high volumes of iodinated contrast media (CM) injected during the examination represents the main limitation of CTA with a dose-dependent association with contrast-induced nephropathy. Purpose Show the feasibility of an ultra-low-dose CM pulmonary arterial injection protocol for CTA in TAVI candidates in high risk patients with severe renal failure. Methods In our retrospective study seventy-seven (77) patients with CKD on stage 3b or worse (eGFR ≤ 45/min/1.73 m2) underwent pre-procedural CTA for TAVI-planning with a pulmonary arterial administration of CM. All CTA examinations were performed using a Dual Source 256-slice CT system. All enhanced CT acquisitions were performed using our dedicated biphasic injection protocol composed of two connected phases of contrast medium injection using different amount of CM (8, 10, 15 and 20 ml) according to BMI (<22 kg/m2; 22-24 kg/m2; 24-28 kg/m2; >28 kg/m2). The CM was administered directly into the pulmonary artery in all patients. For each examination was measured Intraluminal attenuation at thoraco-abdominal aorta and along the ilio-femoral vessels using the ROI (mean SD in HU) as objective image parameters (Picture 1). Serum creatinine and the eGFR were recorded pre-TAVI CT scan and after the procedures as reference of CM to renal function. Results CTA was successfully performed in all patients. Mean creatinine was 2.25 ± 0,76 mg/dL and mean GFR was 26.5± 8.1 mL/min/m2. Mean vessel attenuation was 352±164 HU at the aortic annulus, 238.1 ± 141,3 HU in the aortic arch and 266±168 in the iliac arteries (Picture 2). The mean image noise was 28.2 ± 7 HU in the aortic annulus, 24.4 ± 10,9 in the right external iliac artery, and 25. ± 12,8 HU in the left external iliac artery. After CTA examination, a total of 74 patients (96%) underwent TAVI. Mean CM dose administered during TAVI procedure was 150,6 ± 85,8. Three patients (3.9%) were abolished for TAVI. Postprocedural settings complications were recorded. A total of 31 patients (41%) had grade 1 paravalvular regurgitation, 10 patients (14%) grade 2. No cases of valve embolization or anulus rupture occured. No major vascular complications occured. No significant differences between creatine and eGFR pre and post procedures (p<0,001). Conclusions The use of an ultra-low-dose CM pulmonary arterial injection protocol for CTA in TAVI candidates does not affect the renal function and procedural success rate is high and the clinical outcomes after TAVI is satisfactory according to the litterature.

Transcatheter closure of atrial septal defect (ASD) in adult and paediatric population without transoesophageal echocardiography/general anaesthesia

Abstract Background Transcatheter device closure is the preferred therapeutic option for ostium secundum atrial septal defect(OS-ASD). Standard practice is to perform it under transoesophageal echocardiography(TEE) guidance. However, TEE is performed under general anaesthesia (GA) and leads to increases in cost, procedural duration, ICU stay, total hospital stays, risk of oesophageal injury and complications of GA. Transthoracic echocardiography(TTE) is an excellent alternative and prior studies have shown it to be a safe alternative in paediatric population. In current study we analysed safety and efficacy of TTE-guided device closure of OS-ASD in all comer population irrespective of age, weight, defect size. Methods The study enrolled all patients who underwent device closure of OS-ASD between March 2017 and December 2023. All procedures were performed under LA for adults and conscious sedation for children. The device was placed under fluoroscopy guidance and position were confirmed on TTE. Procedural success, device, defect size ratio, procedural time, fluoroscopy time, complications, intensive care unit/hospital stay duration were analysed and compared with our own experience of 125 patients with TEE-guided closures before switching to complete TTE-guided procedure(before 2017). Results 340 patients underwent TTE-guided device closure of ASD. Procedure success was 97.4% with acceptable risk of major complications. Three(0.8%) had embolization into pulmonary artery, successfully operated surgically. Two had tamponade requiring drainage. In 9 patients, device could not be deployed despite multiple attempts and approaches. All of these had defect size of > 34mm and deficient IVC rim along with shorter (other than aortic) rim. Findings were compared with our own previous experience of TOE guided closure (practised before 2017). Compared to TOE group, TTE group had significantly lower total procedural duration (75±4 vs. 28 ±1 min; p < 0.01), intensive care unit stay (24±10 vs. 10.5±1 h; p < 0.01), and hospital (48±12 vs. 25.5±4h; p < 0.01) stay duration. Fluoroscopic time was similar in both. There was no mortality in either group. Major complications were comparable, TTE-guided group had less post-procedure complications of vomiting and headache. Additional findings of less pre-procedure fasting duration and early commencement of post procedure oral intake were noted in TTE group. Conclusion TTE-guided device closure of OS-ASD is a safe and feasible in all-comer population in experienced hands. It can definitely negate the use of TEE except in very poor echo window. The added advantages include utilization of physiological variations in PV/LV pressure during cough, Valsalva manoeuvres in awake patients. It definitely reduces the procedural duration, cost of procedure and dependence on GA and trained transoesophageal echocardiographer.

Extracranial systemic embolic events in patients with atrial fibrillation: an individual patient-level meta-analysis of 71 683 patients randomized to NOAC vs warfarin from the COMBINE-AF study

Abstract Background Atrial Fibrillation (AF) poses a significant risk for both ischemic stroke and systemic embolic events (SEE). While the effectiveness of NOAC in preventing ischemic stroke is well-established, there is a lack of detailed analyses specifically characterizing SEE, which constitutes 5- 10% of all embolic events. Purpose To study the clinical characteristics, procedural management, and outcomes by randomized treatment (NOAC vs warfarin) of patients with SEE. Methods Using the COMBINE AF dataset, we conducted an individual patient level meta-analysis of 4 global RCTs (RE-LY, ROCKET AF, ARISTOTLE, ENGAGE AF-TIMI 48) of warfarin vs. NOAC in AF to assess risks of SEE. Outcomes were analyzed as time-to-first-event using a Cox proportional hazards model. Two authors independently reviewed deaths within 30 days after SEE to identify fatal SEE. Moreover, we independently assessed post SEE procedures to determined relatedness to SEE. Results There were 188 total SEEs, 9 patients (5%) had SEE then developed ischemic stroke; 16 patients (9%) had ischemic stroke then developed SEE; 1 patient had SEE and ischemic stroke simultaneously. Among the 171 patients with SEEs as first event, the median (IQR) age was 75 (68-80) years, 49.7% were female, median (IQR) of BMI was 27.5 (23.5-30.7) kg/m2, mean (SD) of CHADS2-VASC score was 4.7 (1.5). As compared with ischemic stroke (n=1789), SEE patients were more likely to have, PAD (16.5% vs. 5.4%, p <0.001), prior MI (24% vs. 17%, p = 0.02), be Vitamin K Antagonist experienced (57% vs 46%; p=0.007), have worse renal function (median CrCl mL/min; 58 vs 62, p = 0.02) and less likely to have paroxysmal AF (14% vs. 20%, p = 0.05). Of the total of 188 SEEs, 33 (18%) were fatal, 62 (31%) patients underwent surgical or percutaneous intervention (Fig). Standard dose (SD) NOAC significantly reduced the risk of SEE by 29% (95% CI 1-49%, p=0.04) compared with warfarin, However, no significant difference in the risk of SEE was observed between low dose (LD) NOAC and warfarin (Fig). Conclusion Standard dose NOAC was superior to warfarin in preventing SEE in AF patients. This benefit trends to be more pronounced for fatal cases. While SEE were about 1/10th as frequent as ischemic stroke in patients with AF, they were associated with significant morbidity and mortality and often required surgical or percutaneous intervention to restore blood flow.

Feasibility and efficacy assessment of a novel size-adjustable cryoballoon for ablation of atrial fibrillation in a multicenter clinical setting

Abstract Background The POLARx-FIT cryoballoon (CB) system introduces a unique feature, allowing the selection of two distinct balloon sizes within a single catheter. This innovation holds promise for treating larger pulmonary veins (PV), providing increased flexibility to achieve optimal occlusions. However, there is a scarcity of clinical data supporting its application in this context. Purpose To compare the benefits and safety of the new POLARx-FIT system to those of the existing POLARx system currently in use for PV isolation (PVI) in patients with atrial fibrillation (AF). Methods The first 140 consecutive patients who underwent CB-based PVI with the POLARx-FIT system were retrospectively compared with 300 consecutive patients treated with the POLARx system. Protocol-directed cryoablation was delivered for 180 sec or 240 sec according to operator’s preference for isolation achieved in ≤60 sec, or 240 sec if isolation occurred >60 sec or when time to isolation was not available. The ablation endpoint was PVI as assessed by entrance and exit block. In the POLARx-FIT group the choice of balloon size (28 or 31 mm) was determined during the procedure while attempting to occlude each vein. Results Two-thousand one-hundred fifty-five cryo-applications (CBA) from 440 patients were analysed (300, 68.2% POLARx; 140, 31.8% POLARx-FIT). PVI was achieved with cryoablation only in all patients. The mean number of freeze applications per patient was similar between groups (5.0±1.4 in the POLARx-FIT vs 5.3±1.8 in the POLARx group, p=0.207) whereas the number of PVs treated in a single-shot fashion was higher in the POLARx-FIT group (444, 80.7% with one shot; 75, 13.7% with 2 shots; 31, 5.6% with more than 2 shots) than in the POLARx one (1168, 70.2% with one shot, p=0.0002; 294, 17.7% with two shots and 143, 8.6% with more than two shots). Among the POLARx-FIT cases, in 54.2% (n=298) of applications, the 31-mm diameter was employed as a first choice, while in the remaining 45.8% (n=252) of applications, the 28-mm diameter was adopted. A switch to a different balloon diameter was applied in 11.6% of cases. The first pass isolation (i.e. a single shot CBA to achieve PVI) was slightly higher when using a 31 mm diameter (n=250, 83.9%) than a 28 mm diameter (n=194, 77.0%, p=0.05). Three (0.7%) transient phrenic nerve palsy were observed (all in the POLARx group, 0.9%, p=0.554), with full recovery in the 48-h post procedure; no major procedure-related adverse events were reported at 30 days post-procedure. Conclusion In this first multicentric experience in a clinical practice setting, this novel cryo-balloon system proved to be safe and effective and resulted in a high proportion of successful single-freeze isolation. The intraprocedural flexibility of balloon size contributed to its versatility, leading to a variation in balloon diameter in about 12% of freeze applications.

Pulmonary arteriovenous malformation in children.

Pulmonary arteriovenous malformations (PAVMs) are rare abnormalities observed mainly in children with hereditary haemorrhagic telangiectasia (HHT). A majority of patients are asymptomatic at the time of detection. However, complications such as hypoxemia, stroke, cerebral abscess and massive hemoptysis can arise if larger PAVMs remain untreated. Larger PAVMs are usually managed successfully with embolization, although reperfusion of PAVMs have been reported post procedure. Early screening for PAVMs is recommended in asymptomatic children with HHT or those at risk for HHT. Longer term surveillance is also essential, to enable timely identification and management of PAVMs.

Patient Perception and Experience of Laparoscopic Excision vs. Ablation of endometriosis: a crowd-sourced comparative evaluation of symptom and Quality of Life outcomes

Study Objective: To compare laparoscopic Ablation and Excision in terms of symptom and Quality of Life outcomes as perceived by endometriosis patients. DesignA Cohort, Method comparison Questionnaire-based study SettingEndometriosis-focused Social Media site PatientsEndometriosis patients with history of Laparoscopic Ablation and Excision. InterventionsOn-line questionnaire focused on pre and post procedure (ablation and excision) outcomes across 63 measures in 5 realms: Physical Symptoms, Functional Impact, Psycho-emotional Impact, Social/Sexual Impact, Economic/Educational Impact. Measurements and Main Results232 respondents with surgical history that included laparoscopic ablation and excision (without concomitant or interposed hysterectomy) identified for ablation only physical symptom improvement of 11.3% and 8.5% for dysmenorrhea and menorrhagia respectively. Ablation provided no significant improvement in any other physical symptom measure. Excision was identified as providing improvements across all symptoms ranging from 28% to 46%.In terms of Functional Impact, ablation provided non-significant improvements or worsening of status. Excision demonstrated significant improvement for patients across most measures of Functional Impact.In terms of Psycho-emotional Impact, a worsening of QoL status is identified in 23 of 24 measures following ablation. Excision demonstrated improvement in 22 of 24 measures.For Social-Sexual Impact, ablation resulted in worsened status across all measures with excision demonstrating improvements in all measures, significantly so in most.For Economic/Educational Impact, significant worsening of measures or insignificant improvements were demonstrated following ablation. Excision demonstrated significant improvement in most measures.In all realms, pre-Excision status was worse than pre-Ablation.Allowing for a more focused comparison of ablation and excision, 113 respondents with a surgical history of ablation sequentially followed by excision demonstrated outcomes similar to the larger group: overall worsening of status resulting from ablation and overall improvement in status following excision with pre-Excision morbidity higher than pre-Ablation. ConclusionIn this cohort of patients undergoing laparoscopic endometriosis excision after having undergone endometriosis ablation, the former demonstrated greater beneficial effect over a broad spectrum of symptom and QoL measures.

Comparison of Chemotherapy Combined with Percutaneous Electroporation and Chemotherapy Alone in the Management of Locally Advanced Gallbladder Carcinoma (GBC): A Study Protocol.

This study aims to evaluate the feasibility and efficacy of chemotherapy combined with irreversible electroporation (IRE) in patients with locally advanced gallbladder carcinoma (GBC) presenting as gallbladder masses. Patients with unresectable GBC masses of size greater than 2cm and less than 6cm without evidence of distant metastases and with no contraindication to general anaesthesia will be enrolled in the study. They will be randomized using computer generated table into two arms with 1:1 allocation ratio to include 15 patients in each group. Group I will be the chemotherapy alone arm and Group II will be the combined image-guided irreversible electroporation of the tumour and chemotherapy arm. The primary outcome assessed shall be the clinical benefit rate (complete response, CR; partial response, PR and stable disease, SD) based on the mRECIST criteria and overall survival. The secondary outcome shall be feasibility and safety of the procedure and quality of life pre and post procedure. The quality of life will be assessed by a questionnaire as given by EORTC-Quality of Life Group before starting therapy and 4weeks after completion of therapy. The combined local and systemic effects of irreversible electroporation and systemic chemotherapy respectively may improve the outcomes in inoperable cases of gallbladder carcinoma. Clinical Trials Registry - India ( https://ctri.nic.in/Clinicaltrials/advancesearchmain.php ). Identifier: CTRI/2021/05/033803. Primary Register of the International Clinical Trials Registry Platform (WHO ICTRP) ( http://www.who.int/ictrp/search/en/ ).

Gum grief: Unprecedented fenestration post microneedling procedure for gingival depigmentation – A case report

Gum grief: Unprecedented fenestration post microneedling procedure for gingival depigmentation – A case report

ThP7.10 - Perioperative Temperature in Relation to Theatre Temperature in Orthopaedic Trauma Patients in a District Hospital in NHS

Abstract Aim To understand the relation between intraoperative hypothermia and theatre temperature in Orthopaedic trauma list. Method Prospective analysis of patients listed in the trauma list at a busy district general hospital in NHS. The data collected included duration of surgery, preoperative temperature, pre induction temperature, intra-operative, post procedure, temperature in recovery and temperature post recovery, and mean ambient theatre temperature. Statistical calculations were performed on StatsDirect3 software. Results A total of 100 patients were included in the study from 1 Aug 2023 to 30 September 2023. Intraoperative hypothermia (core body temperature <= 36) was 21%. Preoperative temperature (p=0.033) and preinduction temperature (p<0.001) was statistically significant factor in influencing the intraoperative temperature. Theatre temperature was an independent predictor of intraoperative hypothermia on regression analysis (p<0.001). Conclusions Theatre temperature of 19.5 to 20.5 °C results in a core body intraoperative temperature of 36.3 to 37.3°C. Temperatures below 19.5 results in higher incidence of hypothermia. Preinduction temperature of 36.4°C results in intraoperative temperature of 36°C and a preinduction temperature of 37.1°C leads to intraoperative temperature of 36.7°C. This indicates that preoperative warming as well as a theatre temperature of 19.5 to 20.5 °C will help in reduction of the intraoperative hypothermia.

Does the Use of Potential Pancreatotoxic Drugs Increase the Risk of Post-Endoscopic Cholangiopancreatography Pancreatitis?

Background and Aim: Endoscopic retrograde cholangiopancreatography (ERCP) is a valuable procedure for pancreatobiliary disorders but carries significant risks, including post-ERCP pancreatitis (PEP). The exact cause of PEP is unclear, but mechanical and thermal injuries during the procedure and patient-related factors have been implicated. This study aims to investigate the possible contribution of potential pancreatotoxic drug (PPD) exposure to PEP risk. Methods: This was a retrospective, single-centre, cohort study conducted at Canberra Hospital, a tertiary university hospital. Consecutive ERCP performed with native papillae within a 4-year period from January 2019 to January 2023 were evaluated. Details of ERCP procedures, patient characteristics, and all medications were contemporaneously collected. All patients had follow-up phone calls or review within 24 h post procedure. The diagnosis of PEP was based on the Cotton consensus definition. Results: A total of 32 out of 444 patients (7.2%) developed PEP. There was no significant difference in the incidence of PEP between patients taking PPD compared to patients who were not (7.1% vs. 7.6%, p = 0.845). Three factors were independently associated with PEP in the multivariate analysis: the presence of a periampullary diverticulum (OR = 5.4, 95% CI 1.7–15.3, p = 0.002), the performance of pre-cut sphincterotomy (OR = 2.8, 95% CI 1.2–6.4, p = 0.017), and pancreatic duct cannulation (OR = 3, CI 1.3–7, p = 0.01). Conclusions: The overall incidence of pancreatitis in our selected group of ERCP patients with native papillae was 7.2%. Our study did not find the use of PPD to be a statistically significant risk factor for PEP.

Pre-Cut Papillotomy Versus Endoscopic Ultrasound-Rendezvous for Difficult Biliary Cannulation: A Systematic Review and Meta-Analysis.

Various endoscopic techniques are employed to achieve biliary cannulation when confronted with difficult biliary access. Every procedure carries its own risk in terms of bleeding, infection, pancreatitis, and cholangitis. Our meta-analysis aimed to compare pre-cut papillotomy and endoscopic ultrasound (EUS)-rendezvous in terms of technical success rates, and post-procedure pancreatitis and bleeding. We conducted a systematic review and meta-analysis of studies that compared pre-cut papillotomy and EUS-rendezvous. The primary outcome was technical success by achieving biliary cannulation. Secondary outcomes were postoperative pancreatitis and bleeding. A random-effects model was used to calculate the risk ratios (RRs) and confidence intervals (CIs). A P value < 0.05 was considered statistically significant. Our meta-analysis included four studies comparing pre-cut papillotomy and EUS-rendezvous. The studies included 13,659 total endoscopic retrograde cholangiopancreatography (ERCP) procedures, of whom 1,004 patients underwent alternate biliary cannulation procedures due to difficult biliary cannulation. The mean age of the study population was noted to be 49.5 years and males represented 53.3% of the total participants. Both procedures were similar in terms of technical success (RR: 0.95, 95% CI (0.88, 1.02)). No difference was found between rates of post procedure pancreatitis (RR: 1.82, 95% CI (0.80, 4.15)) and post procedure bleeding (RR: 2.80, 95% CI (0.67, 11.66)). There was no difference in technical success of procedure or post-procedure complications such as pancreatitis and bleeding between pre-cut papillotomy and EUS-rendezvous technique. More randomized controlled trials (RCTs) are needed to compare both procedural techniques and complications rates. However, currently, both procedures are equally effective and safe during difficult biliary cannulation in the hands of experienced endoscopists.

Preprocedural Paracetamol Reduces Pain Scores in Patients Undergoing in-Office Laryngeal Procedures.

To investigate the utility of preprocedural paracetamol on reducing pain scores post office-based laryngeal procedures. Prospective, controlled before-after comparative study. Controlled prospective before-after study. A retrospective analysis was performed of 100 patients who underwent office-based laryngeal procedures without preprocedural analgesia at our center to establish a control group. Age, sex, procedure type, and amount of substance used were documented as well as postprocedural pain score. Pain scores were recorded every 5 minutes for 30 minutes following office-based laryngeal procedures. A prospective arm of this study was then performed in which every patient undergoing office-based laryngeal procedures at our center between September 2019 and December 2020 was administered 1000 mg of paracetamol prior to their procedure. The postprocedure pain scores of the 2 groups were then compared. A hundred patients were included in the retrospective arm and 75 patients were included in the prospective arm, receiving 1000 mg of paracetamol a median of 45 (interquartile range: 30-53) minutes prior to their procedure. The 2 groups were matched for age, sex, and type of laryngeal procedure. Both nonanalgesia and analgesia groups demonstrated a similar proportion of patients who experienced any pain (47% and 48%, respectively) postprocedurally. The prospective arm of this study however reported a statistically significant reduction in the magnitude of their pain scores at all points postprocedurally (P = .005). Paracetamol preprocedurally reduces the severity of pain in office-based laryngeal procedures and would be a useful consideration for patients who are likely to experience significant postprocedural pain. Level 3.

Ozaki technique versus ross operation for complex aortic valve diseases in children: A retrospective cohort study.

The Ozaki technique demonstrated promising results in adults, but few studies reported on pediatric patients with limited follow-up time. This study aimed to evaluate the mid-term results of Ozaki technique compared with Ross operation for complex aortic valve (AV) diseases in children. One hundred and seventeen children underwent either Ozaki (n = 64) or Ross (n = 53) operation from January 2017 to December 2023. The primary endpoint was incidence of moderate or severe regurgitation/stenosis (AR/AS) post procedure. No significant difference was observed in age (6.5±3.4 vs. 7.9±4.3 years) and weight (25.9±15.5 vs. 31.0±25.9kgs) at surgery. The Ozaki group had significantly more patients in heart failure (20.3% vs. 1.9%, P = 0.003) before surgery and more patients needed ECMO installation (6.3% vs. 0, P = 0.125) after surgery. The Ozaki group were in worse status with more patients occurred heart failure (20.3% vs. 1.9%, P = 0.003) before surgery and needed ECMO installation (6.3% vs. 0, P = 0.125) after surgery. During follow up (20.4±17.3 vs. 22.7±22.8 months, P = 0.526), five patients (7.8%) in Ozaki group but no patients in Ross group required reoperations. The incidence of moderate or severe AR (28.1% vs. 3.1%) and AS (31.3% vs. 5.7%) were significantly higher than Ross group. Multivariate analysis identified lower age [HR:1.282 (95%CI:1.075-1.529), P = 0.006] and ECMO installation [HR:0.126 (0.018-0.887), P = 0.037] to be risk factors for moderate or severe AR, and higher aortic transvalvular gradient before discharge was confirmed as the only risk factor for moderate or severe AS (≥36mmHg) at follow up in Ozaki group. Ozaki technique may be used as a palliative procedure for complex AV diseases in children, but its' mid-term results were not durable as Ross surgery, especially younger patients.

A Comparative Study Between Open Hemorrhoidectomy and Rubber Band Ligation for Second Degree Hemorrhoids: A Prospective Randomized Control Study

Background: The symptoms of hemorrhoids has a wide spectrum that ranges from bleeding per rectum, itching, prolapse of the hemorrhoidal cushions, thrombosis leading to pain and discomfort, incontinence especially of fluids and mucous discharge. But for surgical management, hemorrhoidectomy is more sustainable in symptom control and has been considered as gold standard. Rubber band ligation has been the most popular amongst non-surgical interventions because of its effectiveness, minimal complication rate and shorter recover period compared to operative procedures. The present study aimed at determining the efficacy and safety of rubber banding ligation procedure versus the standard hemorrhoidectomy for second degree hemorrhoids. Methods: A prospective randomised comparative study was conducted at Department of Surgery, Indira Gandhi Medical College Hospital, Puducherry for 18 months after getting institutional ethical committee clearance. A total no. of 74 cases of 2nd degree hemorrhoids were divided into two groups A (open hemorrhoidectomy) and B (banding) by simple randomization technique of 37 each. A detailed history &amp; examination including per rectal and Proctoscopy examination was done of each patient and the data entered in the pro forma. The description of data was expressed in the form of mean±SD for quantitative data, while frequency and proportion for qualitative data. Results: Totally male patients represented 57% compared to female with 43% 78% of the patients who underwent banding did not have any immediate post-operative complications while only 4 persons reported pain and bleeding post-operatively compared to 12 patients reporting bleeding and 11 patients reporting pain after hemorrhoidectomy. The duration of hospital stay post procedures was found to be lesser in banding group compared to hemorrhoidectomy group with p value being statistically highly significant (p&lt;0.001). Conclusion: Rubber band ligation is very simple, safe, effective outpatient procedure that can be performed for grade II hemorrhoids. It generally requires fewer expertise and instruments. It is found to improve the symptoms of the patients and making them sustain a good quality of life since it has minimal complications.

Serum Vascular Endothelial Growth Factor and Endostatin as an Adjunct to Clinical Decision Making in Managing Radiation-induced Changes Post Gamma Knife Radiosurgery in Spetzler Martin Grade 3 Arteriovenous Malformations Patients: A Pilot Study

BackgroundRadiation induced changes (RIC) are the most common complications observed post GKRS and may be observed within 6-18months post procedure. It has been observed that almost one third of RICs are symptomatic and half of them are persistent. There is no way to predict which patients will develop these changes and to what extent.This was a prospective analytical pilot study with the aim of understanding the role of Serum Vascular Endothelial Growth Factor and Endostatin as a predictive factor for clinically symptomatic RIC in intracranial AVMs Spetzler Martin (SM) grade 3 being managed with primary Gamma Knife radiosurgery.Total of 15 patients were analysed. 60% of them had a history of bleed. The median volume of AVM Nidus was 4.36 cc. One third of the patients had no imaging changes suggestive of RIC at 1 year follow up and 2 of the patients had symptomatic RIC needing intervention. Before Gamma Knife, the median values of serum concentration of Endostatin and VEGF are 34.98 ng/mL and 168.37 pg/mL respectively . The serum values of VEGF at 1 month post GKRS was much less than the pre GKRS values but not found to be predictive of RIC. No correlation could be observed with the levels of serum endostatin and RIC.Some patients may develop resistant oedema and necrosis post GKRS for intracranial AVMs which may warrant medical and surgical intervention. Serum biomarkers like VEGF and Endostatin may vary in post GKRS period fpo can be used to identify at risk cases, however more studies are needed to decide on appropriate time of sampling and identify clinically relevant predictive factors.

Neuromodulation in Management of Patients with Failed Back Surgery Syndrome. An Outcome Assessment Study

Abstract Background Failed back surgery syndrome (FBSS) is a constellation of conditions that describes persistent or recurring low back pain following spine surgeries with a reported point prevalence in the general adult population of 37% and a lifetime prevalence of between 60% and 85%. It always has a significant impact on patients’ quality of life. Neuromodulation such as spinal cord stimulation has been showing significant effect and improvement in pain scores and functional capacity of the FBSS patients with a reflected effect on their daily activities and quality of life. Aim and Objectives Our aim in this study is to assess the change in pain scores, quality of life and opioid medications intake as an outcome of neuromodulation procedures performed to patients diagnosed with failed back surgery syndrome, and to detect the post procedure complications. Subjects and Methods This is a mixed prospective-retrospective study conducted at Ain Shams University (ASU) hospital and Oregon Health and Science University (OHSU) hospital during the period from September 2019 till December 2022. Patients who are 18 years old or older diagnosed with FBSS for more than 6 months and treated with spinal cord stimulation with successful trials during this time frame were included in the study. Results 34 patients were included in this study who had successful SCS trials and underwent a permanent implantation of SCS devices with post procedure follow up period of 12 months. Patients showed median pain numerical rating scale (NRS) of 7/10 at baseline with median NRS of 4/10 through the follow up period, also, there was a significant improvement of functional capacity using metabolic equivalent assessment with 74% of patients became moderate capacity compared to 32% at baseline. Quality of life assessed by activity measure of post-acute care (AM-PAC) showed significant improvement from mean of 16.87 ± 2.74 at baseline to mean of 19.97 ± 2.93 through follow up. Also there was a significant reduction of opioid medication usage. Post procedure complications was of low percentage with the most commonly detected were battery dysfunction in 7 patients and pocket pain in 6 patients. Reoperation was needed in 13 patients with 4 needed just revision and 9 patients required a complete removal of the device. Conclusion Failed back surgery syndrome is a widely described chronic pain condition which has a negative impact on the patients’ quality of life and daily activities with an evidenced effect on chronic use and abuse of opioid analgesic medications. We presented in our study that SCS could be offered as an effective modality of treatment with a statistically significant reduction in pain scores and a significant improvement in functional capacity and quality of life. Also, it has a recognizable but not statistically significant reduction in opioid analgesic medications and a very low percentage of procedure related complications.

Retrospective Analysis of Paraparalysis/Paraparesis Post Aortic Aneurysm Endovascular Repair

Abstract Objective Paralysis post TEVAR is a challenging complication, this study discusses its incidence, Risk factors, clinical outcome, reversibility, protective strategy and associated mortality. Methods Retrospective study Conducted on patients underwent thoracic and thoracoabdominal aortic Aneurysm Endovascular Repair in Last 11 years (January 2012 till June 2022) in single center as regard incidence, personal history, medical and surgical risk factors, preventive strategies, reversibility of paralysis and associated mortality. Data was obtained from records; paralysis was diagnosed through clinical examination immediately after emergence from anesthesia and frequently post operatively in SICU or even word and after discharge in follow-up outpatient clinic visits. Results A study carried on 137 patients, 15 patients of them developed lower limb paralysis with incidence of 10.9%, 3 patients of them (23.1%) developed paralysis immediately post operative, 4 patients developed paralysis in day 1 post operative (30.8%). And the rest of patients developed delayed onset paralysis (more than 24 Hour post procedure), The latest one developed paralysis 26 days post operative, 8 of paralyzed patients had spinal cord imaging (MRI) 4 of them (50%) didn’t show any abnormality and 3 of them (37.5%) showed spinal cord ischemia and 1 patient didn’t tolerate the MRI machine so the study was discontinued. According to reversibility, 9 patients had complete reversal of their motor and sensory symptoms to the baseline preoperative status. 2 patients had partial reversal of their symptoms, and 4 patients had persistent symptoms without any improvement despite the routine management that included elevating MAP and draining CSF to less than 10 mmHg in order to maintain spinal cord perfusion pressure at level of 80 mmHg and giving naloxone. Data showed 12 out of 81 patients (14.8%) who had functioning spinal drain developed paralysis. Duration of procedure is the most affecting risk factor on paralysis, patients with mean duration of 270 minutes had higher risk of paralysis. Conclusion Prediction of paralysis post TEVAR is still difficult and data analysis showed that the duration of procedure is the only statistically significant variable that we can rely on.

BOOM: A novel bifurcation stent technique using optical coherence tomography co-registration

Background/purposeBifurcation lesions comprise 20 % of percutaneous coronary interventions (PCI) and are associated with worse long-term outcomes. With an increasing percentage of patients presenting with complex anatomy, including bifurcation disease, there is a need for treatment strategies to optimize PCI outcomes. Methods/materialsWe retrospectively analyzed 48 patients undergoing OCT guided bifurcation PCI using the ‘Bifurcation and Ostial OCT Mapping’ (BOOM) technique. The primary efficacy variable studied was stent precision following deployment, defined as the distance of the most proximal stent strut from the true ostium of the target vessel. Additionally, targeted follow-up occurred by phone at 6- and 12-months post procedure, where the frequency of myocardial infarction, target lesion revascularization, target vessel and non-target vessel revascularization, and mortality were collected. ResultsA total of 40 (83.3 %) had an ostial lesion that required treatment while the remaining patients had true bifurcation disease. Most target lesions were in either the LAD or its branches (29 lesions (60.3 %)). With respect to stent positioning, the median absolute geographic miss, (i.e., stent protrusion into the main branch or lack of complete ostial stent coverage), was 0.75 mm. At 6 months, one patient required target lesion revascularization with no additional patients at 12 months. ConclusionsBOOM is a safe and simple strategy that can be a useful technique to optimize precise stent placement for ostial and bifurcation lesions.

Effect of Filtered Blood Return on Outcomes of Pulmonary Aspiration Thrombectomy

ObjectivesTo assess the effects of filtered blood reinfusion (FBR) on procedural outcomes of aspiration thrombectomy for pulmonary embolism (PE). Materials and MethodsA total of 171 patients who underwent aspiration thrombectomy for intermediate-high–risk or high-risk PE between December 2018 and September 2022 were included, 84 of whom underwent thrombectomy with FBR and 87 without. Demographic data, vital signs, laboratory values, procedural details, pulmonary arterial pressures, transfusion needs, length of hospital stay, and procedure-related adverse events were recorded. ResultsThe groups did not differ at baseline, other than the FBR cohort having a higher percentage of women. There was no significant difference in postprocedural vital signs or pulmonary arterial pressure. Mean fluoroscopy time and volume of contrast medium used were lower in the FBR cohort. The drop in hemoglobin level was lower in the FBR group at both 12 (FBR, −1.065; No FBR, −1.742; P > .001) and 24 hours (FBR, −1.526; No FBR, −2.380; P > .001) after procedure; accordingly, fewer patients required transfusions in the FBR cohort (FBR, 8 (9.5%); No FBR, 20 (23.0%); P = .016). There was no difference in the number or severity of adverse events or duration of intensive care unit or hospital admission. ConclusionsFBR use during aspiration pulmonary thrombectomy reduced blood loss and transfusion requirements but had no significant effect on procedural success or adverse event rates.