Long-term Clinical Success Rate Research Articles

Paper 15: Survivorship of 157 Arthroscopic Meniscal Allograft Transplants Using Bone Fixation at Mean 7 Years and Prognostic Factors Analysis

Objectives: Meniscal allograft transplantation (MAT) is an accepted and effective treatment option in the context of unsalvageable menisci, particularly in young and active patients. It has been shown to reduce pain and improve knee function in previously symptomatic patients. However, there is still limited knowledge about the long-term survival rates of allografts, the durability of clinical results, and the influence of patient-specific parameters, such as leg alignment, tibial slope, and preoperative International Cartilage Regeneration & Joint Preservation Society (ICRS) grade. The purpose of this study was to determine (1) the long-term clinical success rate after MAT with bony fixation in a large, single-center cohort of consecutive patients, and (2) if patient-specific and procedural variables influence the clinical, anatomic, and subjective outcomes and risk of failure. Methods: Data on 185 consecutive knees undergoing MAT in a single institution were prospectively collected and screened for inclusion in this study. The minimum follow-up time was 2 years. Radiographic variables (International Cartilage Regeneration & Joint Preservation Society [ICRS] grade and Kellgren and Lawrence grade) were assessed preoperatively and at follow-up. Subjective patient-reported outcome measures (PROMs), Lysholm score, Knee Disability and Osteoarthritis Outcome Score (KOOS) including subscores, International Knee Documentation Committee (IKDC) score, and visual analog score (VAS) were collected preoperatively and at follow-up. Clinical failure was defined as revision surgery due to graft failure or conversion to total knee arthroplasty (TKA). Anatomic failure was considered a tear covering >20% of the allograft, any peripheral tear, and unstable peripheral fixation leading to dislocation of the graft. Subjective failure was defined as Lysholm score ≤65. Preoperative tibial slope and leg alignment were assessed. Survival analyses were performed utilizing the Kaplan-Meier estimate. Univariate and multivariate analyses were performed to determine risk factors for clinical and anatomic failure. Results: A total of 157 knees met inclusion criteria (Table 1). After a mean follow-up time of 7 ± 3.5 years, 127 (80.9%) knees were free of clinical, anatomic, and subjective failure. Fourteen (8.9%) knees experienced clinical failure, 26 (16.6%) knees were identified as anatomic failure, and 13 patients (8.3%) suffered from subjective failure with a reported Lysholm score of ≤65 at a mean follow-up of 7 years. Concurrent osteochondral allograft transplantation was identified as a predictor of both clinical (HR 4.55; 95% CI 1.46-14.17; p=0.009) and anatomic failure (HR 3.05; 95% CI 1.34-6.92; p=0.008). Cartilage damage of ICRS grade 3 or 4 of the index compartment conveyed an increased risk for clinical (HR 3.41; 95% CI 1.05-11.01; p=0.04) and anatomic failure (HR 3.04; 95% CI 1.31-7.11; p=0.01) (Table 2). There were no differences in outcomes between medial and lateral MAT. High-grade cartilage damage (defined as ICRS grades 3 and 4) preoperatively (HR 10.67; 95% CI 1.037-109.768; p=0.046), patients age over 25 (HR 5.44; 95% CI 0.120-246.070; p=0.384), and a body mass index >30 (HR 2.24; 95% CI 0.748-6.705; p=0.149) were associated with subjective failure. Considering the entire study population, PROMs including KOOS and IKDC were significantly improved at final follow-up compared to preoperative scores across all measurements (p<0.005). Conclusions: MAT showed good-to-excellent clinical results at a mean follow-up of 7 years. Low ICRS lesion grade was associated with a higher clinical and anatomic survival rate. Patients with concurrent osteochondral allograft transplantation are at higher risk of clinical and anatomic failure, but still report significantly improved PROMs. These results suggest MAT has a lasting beneficial effect both as in isolation and in complex cases with one or more concurrent procedures.

Efficacy, Feasibility, and Safety of the X-Tack Endoscopic HeliX Tacking System: A Multicenter Experience.

The application of endoscopic suturing has revolutionized defect closures. Conventional over-the-scope suturing necessitates removal of the scope, placement of the device, and reinsertion. A single channel, single sequence, through-the-scope suturing device has been developed to improve this process. This study aims to describe the efficacy, feasibility, and safety of a through-the-scope suturing device for gastrointestinal defect closure. This was a retrospective multicenter study involving 9 centers of consecutive adult patients who underwent suturing using the X-Tack Endoscopic HeliX Tacking System (Apollo Endosurgery). The primary outcomes were technical success and long-term clinical success. Secondary outcomes included adverse events, recurrence, and reintervention rates. In all, 56 patients (mean age 53.8, 33 women) were included. Suturing indications included fistula repair (n=22), leak repair (n=7), polypectomy defect closure (n=12), peroral endoscopic myotomy (POEM) site closure (n=7), perforation repair (n=6), and ulcers (n=2). Patients were followed at a mean duration of 74 days. Overall technical and long-term clinical success rates were 92.9% and 75%, respectively. Both technical and clinical success rates were 100% for polypectomies, POEM-site closures, and ulcers. Success rates were lower for the repair of fistulas (95.5% technical, 54.5% clinical), leaks (57.1%, 28.6%), and perforations (100%, 66.7%). No immediate adverse events were noted. This novel, through-the-scope endoscopic suturing system, is a safe and feasible method to repair defects that are ≤3cm. The efficacy of this device may be better suited for superficial defects as opposed to full-thickness defects. Larger defects will need more sutures and probably a double closure technique to provide a reinforcement layer.

Survivorship of 157 Arthroscopic Meniscal Allograft Transplants Using Bone Fixation at a Mean of 7 Years and Prognostic Factors Analysis

Background: Meniscal allograft transplantation (MAT) is an accepted and effective treatment option in the context of unsalvageable menisci, particularly in young and active patients. It has been shown to reduce pain and improve knee function in previously symptomatic patients. However, there is still limited knowledge about the long-term survival rates of allografts, the durability of clinical results, and the influence of patient-specific parameters, such as leg alignment, tibial slope, and preoperative International Cartilage Regeneration & Joint Preservation Society (ICRS) grade. Purpose: To determine (1) the long-term clinical success rate after MAT with bony fixation in a large, single-center cohort of consecutive patients, and (2) if patient-specific and procedural variables influence the clinical, anatomic, and subjective outcomes and risk of failure. Study Design: Case-control study; Level of evidence, 3. Methods: Data on 185 consecutive knees undergoing MAT in a single institution were prospectively collected and screened for inclusion in this study. The minimum follow-up time was 2 years. Radiographic variables (ICRS grade and Kellgren-Lawrence grade) were assessed preoperatively and at follow-up. Subjective patient-reported outcome measures (PROMs) (Lysholm score, Knee injury and Osteoarthritis Outcome Score [KOOS] including subscores, International Knee Documentation Committee [IKDC] score, and visual analog scale [VAS] score) were collected preoperatively and at follow-up. Clinical failure was defined as revision surgery due to graft failure or conversion to total knee arthroplasty. Anatomic failure was considered a tear covering >20% of the allograft, any peripheral tear, and unstable peripheral fixation leading to dislocation of the graft. Subjective failure was defined as Lysholm score ≤65. Preoperative tibial slope and leg alignment were assessed. Survival analyses were performed using the Kaplan-Meier estimate. Univariate and multivariate analyses were performed to determine risk factors for clinical and anatomic failure. Results: A total of 157 knees met inclusion criteria. After a mean follow-up time of 7 ± 3.5 years, 127 (80.9%) knees were free of clinical, anatomic, and subjective failure. Fourteen (8.9%) knees experienced clinical failure, 26 (16.6%) knees were identified as having experienced anatomic failure, and 13 (8.3%) patients experienced subjective failure with a reported Lysholm score of ≤65 at a mean follow-up of 7 years. Concurrent osteochondral allograft transplantation was identified as a predictor of both clinical (hazard ratio [HR], 4.55; 95% CI, 1.46-14.17; P = .009) and anatomic (HR, 3.05; 95% CI, 1.34-6.92; P = .008) failure. Cartilage damage of ICRS grade 3 or 4 of the index compartment conveyed an increased risk for clinical (HR, 3.41; 95% CI, 1.05-11.01; P = .04) and anatomic (HR, 3.04; 95% CI, 1.31-7.11; P = .01) failure. High-grade cartilage damage preoperatively (HR, 10.67; 95% CI, 1.037-109.768; P = .046), patient age >25 years (HR, 5.44; 95% CI, 0.120-246.070; P = .384), and a body mass index >30 (HR, 2.24; 95% CI, 0.748-6.705; P = .149) were associated with subjective failure. PROMs including KOOS and IKDC were significantly improved at final follow-up compared with preoperative scores across all measurements (P < .005). Conclusion: MAT showed good to excellent clinical results at a mean follow-up of 7 years. Low ICRS lesion grade was associated with a higher clinical and anatomic survival rate. Patients with concurrent OCA transplantation are at a higher risk of clinical and anatomic failure, but still report significantly improved PROMs. These results suggest that MAT has a lasting beneficial effect both in isolation and in complex cases with ≥1 concurrent procedures.

A multi-institutional European comparative study of open versus robotic-assisted laparoscopic ureteral reimplantation in children with high grade (IV–V) vesicoureteral reflux

Traditionally, open ureteral reimplantation (OUR) has been the standard treatment for primary vesicoureteral reflux (VUR) requiring reimplantation. Robotic-assisted laparoscopic ureteral reimplantation (RALUR) is gaining popularity and high success rates have been reported. In this multi-institutional study, we aimed to compare the perioperative and postoperative outcomes of OUR and RALUR for high-grade (IV+V) VUR in children. A retrospective evaluation was performed collecting data from 135 children (0-18 years) who underwent high grade VUR surgical correction at nine European institutions between 01/01/2009 and 01/12/2020, involving either open or robotic approaches. Institutional review board approval was obtained. Patients with lower grades of VUR (≤III), previous history of open or endoscopic ureteral surgery, neurogenic bladder, or refluxing megaureter in need of ureteral tapering were excluded. Pre-, peri- and post-operative data were statistically compared. Overall, 135 children who underwent either OUR (n=68), or RALUR (n=67) were included, and their clinic and demographic features were collected. The mean age of the open group was 11 months (interquartile range [IQR] 9.9-16.6 months), in the RALUR group it was 59 months (IQR 29-78mo) (p<0.01); the open cohort had a weight of 11kg (IQR 9.9-16.6kg) while the RALUR group had 19kg (IQR 13-25kg) (p<0.01). No significant differences were found for intraoperative (1.5% vs 7.5%, p=0.09) or for postoperative complication rates (7.4% vs 9%, p=0.15). Favorable outcomes were reported in the RALUR group: shorter time to stooling (1 vs 2 days), fewer indwelling urethral catheter days (1 vs 5 days), perioperative drain insertion time (1 vs 5 days) and a shorter length of hospital stay (2 vs 5 days) (p<0.01). The success rate was 94.0% and 98.5% in the open and RALUR groups, respectively. The long-term clinical success rates from both groups was comparable:42 vs 23 months for open and RALUR, respectively. This study reported a large multicentric experience focusing on high grade VUR. Furthermore, this study compares favorably to OUR in a safety analysis. There was also a trend towards higher success rates with RALUR utilizing an extravesical approach which has not been previously reported. RALUR is an efficacious and safe platform to use during ureteral reimplantation for high grade VUR. The overall peri-operative and post-operative complication rates are at least equivalent to OUR, but it is associated with a faster functional recovery and time to discharge. Medium to long term success rates are also equivalent to OUR.

Survival and success of veneered zirconia crowns.

The aim of the present study was to evaluate the long-term clinical survival and success rate of veneered zirconia crowns with a modified anatomical framework design after 10 years in function. In total, 36 zirconia crowns were fabricated for 28 patients. An anatomically modified framework design was developed. Crowns were inserted between 2008 and 2009. A follow-up of 19 patients with 28 crowns was conducted in 2020 to document mechanical and biologic parameters. Additionally, a modified version of the pink esthetic score (PES) was documented. Patient satisfaction was assessed using United States Public Health Service (USPHS) criteria. The success and survival rates were calculated using the Kaplan-Meier analysis. After more than 10 years of clinical service, the survival rate of the zirconia crowns was 92.9%. Biologic complications occurred in 12% of the examined crowns, whereas technical complications occurred in 54%. Mostly, chippings (50%) and insufficient marginal gaps (50%) were observed. Most crowns were positively evaluated for more than one technical complication. Periodontal conditions with probing depths of up to 3 mm were comparable with measured values before crown delivery (73% to 75%). Most of the crowns had modified PES values of 10 or higher. Patient satisfaction was high. The modified framework design led to a high survival rate of the crowns but a relatively low success rate. High patient satisfaction and inconspicuous periodontal conditions were demonstrated. Biologic complications occurred far less frequently than technical complications.

Internal Fixation of Unstable Osteochondritis Dissecans of the Knee: Long-term Outcomes in Skeletally Immature and Mature Patients

Background: Osteochondritis dissecans (OCD) is a disorder originating in the subchondral bone, leading to focal lesions with risk of fragmentation and secondary damage of the articular cartilage. It remains controversial if surgical treatment of such lesions is equally successful in skeletally immature and mature patients. Purpose: To determine (1) the long-term clinical success rate after internal fixation of unstable OCD in skeletally immature and mature patients based on physeal status, (2) if patient-specific and procedural variables influence the risk of failure, and (3) patient-reported outcome measures over time. Study Design: Cohort study; Level of evidence, 3. Methods: A multicenter retrospective cohort study was conducted investigating skeletally immature and mature patients treated for unstable OCD lesions of the knee between 2000 and 2015. The healing rate was assessed by radiological imaging and clinical follow-up. Failure was defined as any definitive reoperation for the initially treated OCD lesion. Results: A total of 81 patients met inclusion criteria, including 25 skeletally immature patients and 56 patients with closed physes at the time of surgery. After a mean follow-up time of 11.3 ± 4 years, 58 (71.6%) patients had healed lesions, whereas the lesions failed to heal in 23 (28.4%) patients. No significant difference in risk of failure was observed based on physeal maturation status (hazard ratio, 0.78; 95% CI, 0.33-1.84; P = .56). Lateral versus medial condylar lesion location conferred an increased risk of failure (P < .05) for both skeletally immature and mature patients. Multivariate analysis of skeletal maturity status showed that a lateral femoral condylar location was an independent risk factor for failure (hazard ratio, 0.22; 95% CI, 0.1-0.5; P < .05). The mean patient-reported outcome scores (International Knee Documentation Committee [IKDC] score and Knee injury and Osteoarthritis Outcome Score [KOOS]) increased significantly after surgery and remained high at the final follow-up (P < .05). The final scores (mean ± SD) at a mean follow-up of 135.8 months (range, 80-249 months) were IKDC, 86.6 ± 16.7; KOOS Pain, 88.7 ± 18.1; KOOS Symptoms, 89.3 ± 12.6; KOOS Activities of Daily Living, 89.3 ± 21.6; KOOS Sport and Recreation, 79.8 ± 26.3; and KOOS Quality of Life, 76.7 ± 26.3. Conclusion: The long-term results after internal fixation of OCD fragments show high rates of healing and sustainable subjective improvement of knee function and quality of life. A healing rate of 72% was noted at a mean follow-up of 11.3 years. The stage of skeletal maturity had no significant influence on the rate of failure. Lateral femoral condylar lesion location is an independent risk factor for failure in skeletally mature and immature patients.

Long-term Outcomes of Endoscopic Intraductal Radiofrequency Ablation for Ampullary Adenoma with Intraductal Extension after Endoscopic Snare Papillectomy.

There are limitations in treating ampullary adenomas with intraductal extension using conventional endoscopic modalities. Endoscopic intraductal radiofrequency ablation (ID-RFA) may be useful for treating intraductal (common bile duct [CBD] and/or pancreatic duct [PD]) extensions of ampullary adenomas, but long-term data are lacking. We thus evaluated the long-term outcomes of endoscopic ID-RFA for managing ampullary adenomas with intraductal extension. Prospectively collected endoscopic ID-RFA database at Asan Medical Center was reviewed to identify consecutive patients with ampullary adenoma who underwent ID-RFA for intraductal extension between January 2018 and August 2021. Technical success, short-term and long-term clinical success, and adverse events were evaluated. A total of 29 patients (14 CBD, 1 PD, and 14 CBD and PD) were analyzed. All patients had undergone endoscopic snare papillectomy prior to ID-RFA. A median of one session of ID-RFA (range, 1 to 3) for residual or relapsed intraductal extension of ampullary adenoma were successfully performed (technical success=100%). Both biliary and pancreatic stenting were routinely performed after ID-RFA to prevent ductal stricture. After a median follow-up of 776 days (interquartile range, 470 to 984 days), the short-term and long-term clinical success rates were 93% and 76%, respectively. Seven patients experienced procedural adverse events and three patients developed ductal strictures. Endoscopic ID-RFA showed good long-term outcomes in treating residual or relapsed ampullary adenomas with intraductal extension. Repeated ID-RFA may be considered as an option for managing recurrence. Further studies are needed to standardize the procedure.

Mid-Term and Long-Term Outcomes of Peroral Endoscopic Myotomy for the Treatment of Achalasia: A Systematic Review and Meta-Analysis.

Peroral endoscopic myotomy (POEM) achieves a satisfactory short-term clinical response in patients with achalasia. However, data on mid- and long-term clinical outcomes are limited. We aimed to assess the mid- and long-term efficacy and safety of POEM in achalasia patients. Using the pre-designed search strategy, we identified relevant studies that evaluated the efficacy and safety of POEM with a minimum of 2-year follow-up in the Embase, Cochrane, and PubMed databases from inception to January 2021. Primary outcome was pooled mid- and long-term clinical success rate based on the Eckardt score. Secondary outcome was pooled long-term reflux-related adverse events. A total of 21 studies involving 2,698 patients were included. Overall, the pooled clinical success rates with 2-, 3-, 4-, and 5-year follow-ups were 91.3% (95% confidence interval [CI] 88.4-93.6%), 90.4% (95% CI 88.1-92.2%), 89.8% (95% CI 83.6-93.9%), and 82.2% (95% CI 76.6-86.7%), respectively. Besides, the pooled long-term clinical success rates for type I, II, and III achalasia were 86.1% (95% CI 80.9-90.1%; I2 = 0%), 87.9% (95% CI 84.2-90.8%; I2 = 48.354%), and 83.9% (95% CI 72.5-91.2%; I2 = 0%), respectively. Moreover, the pooled incidence of symptomatic reflux and reflux esophagitis was 23.9% (95% CI 18.7-29.9%) and 16.7% (95% CI 11.9-23.1%), respectively. POEM is associated with a long-term clinical success of 82.2% after 5years of follow-up. Randomized control trials comparing POEM with laparoscopic Heller myotomy or pneumatic dilation with longer follow-up periods are needed to further demonstrate the long-term safety and efficacy of POEM.

The experience of use of percutaneous transhepatic biliary drainages for early biliary complications after liver transplantation.

This study aimed to describe our experience and discuss the results, controversies, and the use of percutaneous transhepatic biliary drainage (PTBD) in patients with biliary complications after liver transplantation (LT). Between November 2009 and August 2020, 76 consecutive patients who underwent 77 LTs (44 deceased donor LTs and 33 living donor LTs [LDLT]) were enrolled retrospectively. Endoscopic therapy as initial approach and PTBD as rescue therapy were used for patients with biliary complications. There were 31 patients (31/76, 40.8%) with biliary complications, and two of them died (2/31, 6.5%). Clinical success rate of endoscopic therapy alone was 71.0% (22/31). The remaining nine patients received salvage PTBD and their clinical results were observed according to whether their intrahepatic bile ducts (IHBDs) was dilated (group A, n=5) or not (group B, n=4). In group A, the technical and long-term clinical success rates of PTBD were 100% and 20%, respectively. These five patients received PTBD ranging from 75 to 732 days after their LTs, and no procedure-related complications were encountered. In group B, the technical and long-term clinical success rates of PTBD were 50% and 25%, respectively. Three group B patients (75%) underwent PTBD within 30 days after LDLT and had lethal complications. One patient had graft laceration and survived after receiving timely re-transplantation. The other two patients died of sepsis due to PTBD-related bilioportal fistula or multiple liver abscesses. Our experience showed salvage PTBD played a limited role in biliary complications without dilated IHBDs within 1 month after LT.

Stability and success rate of dual-thread miniscrews.

To date, the clinical stability of dual-thread orthodontic miniscrews has not been studied. This study aimed to compare the primary stability and long-term clinical success rate of dual-thread and cylindrical orthodontic miniscrews and to examine the association between various clinical factors and the success rate of miniscrews. A total of 145 cylindrical and 135 dual-thread miniscrews were inserted in the maxillary and mandibular buccal alveolar areas of 142 patients. The torque and Periotest (Siemens, Bensheim, Germany) values were recorded during insertion and removal. The effect of clinical variables such as sex, age, screw design, jaw, side of placement, root proximity, and site of placement on the success rate was examined using logistic regression analysis. There was no statistically significant difference (P = .595) in the overall clinical success rate between the two designs, with an overall success rate of 82.1% and 84.4% for the cylindrical and dual-thread miniscrews, respectively. Age and screw-root proximity were significantly associated with failure (P < .05). The dual-thread miniscrews did not show superior long-term stability and clinical success rate as compared with the cylindrical miniscrews. The results of this study suggest that patient age and screw-root proximity influence the clinical success rate of miniscrews.

Thoracic Endovascular Aortic Repair With Additional Distal Bare Stents in Type B Aortic Dissection Does Not Prevent Long-Term Aneurysmal Degeneration

Purpose: TEVAR (thoracic endovascular aortic repair) + PETTICOAT (Provisional ExTension to Induce COmplete ATtachment) technique has been selectively employed since 2005 at our institution during endovascular treatment of type B aortic dissection (TBD). The aim of this study is to evaluate the long-term (>5 years) clinical results and the evolution of aortic volume. Materials and Methods: All the patients receiving an endovascular treatment for TBD with the PETTICOAT technique were collected in a prospectively maintained database and follow-up computed tomography scan were retrospectively analyzed. Study endpoints included short- and long-term clinical success (absence of need for reintervention) and any major adverse event. The volumes of thoracic and abdominal aorta at long-term follow-up were also analyzed. Results: Twenty-eight patients received a TEVAR + PETTICOAT and were followed up (median follow-up 85 months). Primary 30-day clinical success rate was 82% with an adverse event rate of 31%; 4 type I endoleak and 1 retrograde dissection were recorded. Secondary mid-term clinical success was 96% while the long-term clinical success rate was 79%. Six cases (21%) received either an open repair or an endovascular repair for a significant distal aortic enlargement at follow-up. With regards to volumetric analysis, an increase of overall (thoracic and abdominal) aortic volume was observed in 8 cases mainly related to an increase (mean: +31%) of the abdominal volume that was observed in 11 cases. Conclusions: PETTICOAT technique does not protect from long-term significant aneurysmal degeneration that may require aortic open or endovascular reinterventions. Aortic growth occurs mainly in the bare-stented aorta and thus, life-long surveillance is advisable in these patients.

Long-term outcomes of over-the-scope clip for refractory gastrointestinal diseases

Background The Over-The-Scope Clip (OTSC) can effectively treat refractory gastrointestinal diseases. However, most reports have focused on short-term effectiveness. We examined clinical outcomes of the deployed clips and long-term characteristics. Material and methods Of 47 patients with OTSC treatment, 35 with follow-up periods of ≥3 months were retrospectively examined. The indications were 11 bleedings, 17 perforations, and seven fistulas. The observation period was defined as medium-term (3 to <12 months) or long-term (≥12 months). The primary outcome was the clinical success rate without disease recurrence. The secondary outcomes were the complication rate, survival duration, and clip retention rate. Results The medium- and long-term clinical success rates were 100% during the observation period (median, 44 months; range, 3–78 months). The complication rate was 2.9% (n = 1). The median survival time was 1,634 days for bleeding, 1,757 days for perforation, and 444 days for fistulas. The overall clip retention rates were 56.4%, 38.1%, 30.9%, and 25.9% after one, six, and 12 months and at the final follow-up, respectively. The average clip retention duration was 244 days in bleeding, 656 days in perforations, and 188 days in fistulas. Conclusions Regardless of clip detachment, the OTSC can be effective in long-term.

A randomised controlled clinical trial comparing pure Portland cement and formocresol pulpotomies followed from 2 to 4 years.

The purpose of the present prospective randomised clinical control trial was to evaluate the long-term clinical and radiographic success rate of pulpotomies in primary molars using pure Portland cement versus formocresol. Pure Portland cement has shown a high rate of success in pulpotomy treatments, with no side effects. Healthy 3- to 11-year-old children were treated with pulpotomies on primary molars as part of their scheduled dental treatment. Pulp dressing alternated randomly between pure Portland cement and formocresol. Data were analysed at follow-up periods up to 48months. 68 (50%) teeth with pure Portland cement and 68 (50%) teeth with formocresol in 136 healthy children (59 boys and 77 girls) were followed. The overall success rate of the pulpotomies in this study was 95.6%. Pure Portland cement was successful in 100% of the cases (68 out of 68), and formocresol in 91.1% (62 out of 68). No association was found between success and type of tooth or time range from treatment to last follow-up. Based on this study's results, it can be concluded that there is no superiority of one material over the other and pure Portland cement can be used in primary molar pulpotomies.

S2374 Getting Closure: Gastrocutaneous Fistula Repair in the Era of Endoscopic Suturing

INTRODUCTION: Formation of a gastrocutaneous fistula (GCF) is an uncommon complication following gastrostomy tube removal. GCFs rarely close spontaneously leading to nutrition support challenges and poor patient quality of life. Methods for endoscopic closure include glue injection, banding, and use of endoclips, however limited data exists about the efficacy of endoscopic suturing for GCF management. We aimed to evaluate the success of endoscopic suturing in closure of gastro-cutaneous fistulae after gastrostomy tube removal. CASE DESCRIPTION/METHODS: We performed a retrospective study using our electronic endoscopy database between 2018 and 2019. All patients during the study period who underwent endoscopic suture for closure of GCF after gastrostomy tube removal were identified. Data was collected regarding patient characteristics, co-morbid conditions as well as technical success, clinical success and procedure complication rate. Endoscopic suturing of GCF using the Apollo Overstitch system was performed six times in four patients. The average age was 69 years and 75% of patients were female. All patients had previous attempt for closure of GCF with either suturing of the skin (n = 3), bedside debridement (n = 1) or over-the-scope clip (n = 1). Debridement of the fistulous tract was performed in all patients undergoing endoscopic suturing using argon plasma coagulation and/or cytology brush. Endoscopic suturing was technically successfully in 100% of the cases and immediate post-procedure clinical success was achieved in 100% of cases. Long-term clinical success rate was achieved in 3 out of 4 patients (75%) with median follow up of 124 days. No procedure-related complications were observed. The only patient without durable clinical success had an over the scope clip in place which wasn’t able to be removed prior to suturing. DISCUSSION: Our initial experience suggests that endoscopic suturing is a safe and effective modality for closure of gastrocutaneous fistulae following gastrostomy tube removal and may be considered as first line therapy in these challenging clinical cases.Table 1.: Patient demographic data, surgical history, and periprocedural information.Table 2.: Procedural information and outcomes

P1025Incidence and characteristics of pulmonary vein reconduction after second-generation cryoballoon-based pulmonary vein isolation: Impact of different ablation strategies

Abstract Funding Acknowledgements none Introduction The second-generation CB (CB2, Arctic Front Advance, Medtronic Inc., Minneapolis, USA) has demonstrated high procedural success rates, relatively short procedure times, high durability of PVI and convincing long-term clinical success rates. Nevertheless, data on the impact of different ablations protocols on durability after CB2 based PVI is limited. Purpose We aimed at comparing durability of pulmonary vein isolation (PVI) following three different ablation strategies utilizing the second-generation cryoballoon (CB2) in patients with recurrence of atrial fibrillation (AF) or atrial tachycardia (AT) undergoing repeat procedures. Methods In 192 patients a total of 751 PVs were identified. All PVs (751/751, 100%) were successfully isolated during index PVI. Thirty-one out of 192 (16%) patients were treated with a bonus-freeze protocol (group 1), 67/192 (35%) patients with a no bonus-freeze protocol (group 2), and 94/192 (49%) patients with a "time-to-effect"-guided ablation protocol without bonus freezes (group 3). Results Persistent PVI was documented in 419/751 (55.8%) PVs, and in 41/192 (21%) patients all PVs were persistently isolated. The number of patients with all PVs being persistently isolated was not significant between the groups (p = 0.594). The total rate of PV reconnection was not significantly different between the three groups (p = 0.134) and the comparison of individual PVs revealed also no differences for different ablation protocols (p-values for RSPV: 0.424, RIPV: 0.541, LSPV: 0.788, LIPV: 0.346, LCPV: 0.865). The procedure times were significantly reduced in non-bonus freeze ablation protocols and/or when applying individualized application times (group 1: 123.4 ± 31.5min, group 2: 112.9 ± 39.8 min, group 3: 86.67 ± 28.4 min, p &amp;lt;0.001). Conclusions A considerably high rate of persistent PVI was demonstrated in patients after index CB2-based PVI. No differences for durable PVI were detected for different ablation protocols. Therefore, individualized ablation protocols might be a beneficial ablation strategy during CB2-based PVI.

Intermediate and long-term outcomes of a bowel management program for children with severe constipation or fecal incontinence

PurposeWe sought to examine the long-term clinical success rates of a bowel management program (BMP) for children with severe constipation or fecal incontinence. MethodsA single center review was conducted of children (≤18 years) enrolled in a BMP and followed in a colorectal specialty clinic (2011–2017). All patients who completed an initial week of the BMP were included. Patients enrolled in a BMP after 2018 were excluded. Success was defined as no accidents and <2 stool smears per week. ResultsA total of 285 patients were reviewed. BMP was initiated at a median age of 7 years (9 months-17 years). Primary diagnoses included functional constipation (112), anorectal malformation (ARM) (104), Hirschsprung Disease (HD) (41), rectal prolapse (14), spina bifida (6), fecal incontinence (3) and other (5; 4 sacral coccygeal teratomas and a GSW to the buttocks). Initial bowel regimen included large volume enema in 54% and high dose stimulant laxative in 46%. The initial Bowel Management Week (BMW) was successful in 233 (87% of adherent patients) patients with 17 (6%) non-adherent. One hundred twenty-two patients had follow-up at 12 months (72% success amongst adherent patients, 7% of patient non-adherent) and 98 patients had follow-up at 24 months (78% success amongst adherent patients, 10% of patients non-adherent). 21/154 (14%) patients started on enemas were later successfully transitioned to laxatives and 13/132 (10%) patients started on laxatives subsequently required enemas in order to stay clean. Clinic phone contact occurred outside of scheduled visits for adjustment to the BMP in 44% of patients. 33% of patients had surgery to aid bowel management (antegrade colonic enema (ACE) = 81, resection + ACE = 13, diverting stoma = 4). Median follow up was 2.5 years (5 weeks–7 years). ConclusionChildren who follow a structured BMP with readily available personnel to provide outpatient assistance can experience successful treatment of severe constipation or fecal incontinence long-term. A multi-institutional collaboration is necessary to identify factors which predict failure of a BMP and non-adherence. Type of StudySingle-center retrospective chart review. Level of Evidence3

Long-Term Clinical Outcomes and Parental Satisfaction After Dextranomer/Hyaluronic Acid (Dx/HA) Injection for Primary Vesicoureteral Reflux.

Purpose: Endoscopic dextranomer/hyaluronic acid (Dx/HA) injection is a common treatment for vesicoureteral reflux (VUR) with excellent reported short-term clinical success rates. Long-term outcomes are less well-defined. We assessed long-term outcomes and parental satisfaction after Dx/HA injection for primary VUR with >5-year follow-up.Materials and Methods: Families of all patients who underwent Dx/HA injection for primary VUR at our institution between 2008 and 2012 were contacted for telephone interview. Data collected by phone included parental satisfaction and presence and severity of UTIs pre-operatively and post-operatively. Patient demographics, radiographic VUR data, need for secondary surgery, and surgical indications were obtained through chart review.Results: Five hundred and seventy-five patients underwent Dx/HA injection for primary VUR between 2008 and 2012. Ninety-nine (17.2%) of these patients' parents were successfully contacted and interviewed. Median follow-up time from surgery to survey was 8.4 (IQR 6.8–9.6) years. Secondary surgery was performed in 13/99 (13.1%), most commonly repeat Dx/HA injection. Seven patients (7.1%) underwent secondary Dx/HA injection for persistent VUR without UTIs at a median of 0.35 (IQR 0.33–0.77) years post-operatively. Five patients (5.1%) underwent Dx/HA injection (n = 3) or ureteral reimplantation (n = 2) for VUR with febrile UTIs (fUTIs) at a median of 2.2 (IQR 1.3–5.1) years. One patient had ureteral reimplantation for symptomatic obstruction 2.8 years after initial surgery. Only 3/99 (3.0%) required open or laparoscopic surgery after Dx/HA injection. Eighty-three families (84.7%) reported ≥1 fUTIs pre-operatively. Of these, only 9/83 (10.8%) reported fUTIs post-operatively, for an overall clinical success rate of 89.2%. Clinical success was 93.1% in patients whose pre-operative fUTIs were treated outpatient and 80.0% in those hospitalized at least once for fUTI treatment pre-operatively. Ninety-four percent of parents were highly satisfied, 2.4% partially satisfied, and 3.5% dissatisfied.Conclusions: Endoscopic injection with Dx/HA for primary VUR appears to have good long-term clinical success rates and high parental satisfaction, mirroring our previously reported short-term results. Post-operative ureteral obstruction is rare but may occur years post-operatively, justifying initial sonographic surveillance, and repeat imaging in symptomatic patients.

In-vitro Evaluation of Microleakage in Root Canal Obturation with Mineral Trioxide Aggregate and Calcium-enriched Mixture Cement Using Fluid Filtration

Introduction: Endodontic treatment failure is caused by the leakage of microorganisms and endotoxins, which leads to pathological lesions. Adequate seal of the root canal is essential to preventing recontamination and ensuring the long-term clinical success rate. Mineral trioxide aggregate (MTA) and calcium-enriched mixture cement (CEM) are common types of cement with adequate sealing capability in endodontics. The present study aimed to compare the microleakage in the root canals filled with ProRoot MTA and CEM cement using fluid filtration. Methods: This experimental, in-vitro study was conducted on 46 root canals of extracted mandibular premolars. After preparation and disinfection with 3% sodium hypochlorite, the crowns were resected from the cervical region. The teeth were randomly divided into two experimental groups of 20 based on the tested materials (ProRoot MTA and CEM cement), as well as two negative and positive control groups of three. All the samples were instrumented and obturated using the step-back technique, and fluid filtration was used to evaluate sealing ability and leakage inhibition. Data analysis was performed using the Mann-Whitney U test (α=0.05). Results: Mean microleakage in the ProRoot MTA and CEM cement was 2±0.79 and 3.02±1.38 µL/8 min, respectively. In addition, a significant difference was observed between the two groups in this regard (P<0.011).Conclusion: According to the results, ProRoot MTA provided significantly less microleakage compared to the CEM cement. Therefore, the sealing ability of ProRoot MTA was higher than the CEM cement, which makes MTA a better material than CEM cement for canal obturation.

Long-term impact of a bonus freeze on clinical outcome: Analysis of effective and non-effective bonus freezes in cryoballoon ablation.

PurposeData on bonus freeze characteristics and their impact on complication rates and long-term clinical outcome are limited.MethodsPulmonary vein isolation (PVI) using a 28 mm 2nd-generation cryoballoon (CB) was performed in 169 patients (pts). The isolation temperatures, time to isolation and minimal temperatures of the cryoapplications were documented.ResultsThe study included 92 pts who received one bonus freeze after PVI in group I and 77 pts who did not receive a bonus freeze in group II. After a mean follow-up time of 19.0±8.6 months in group I and 16.4±7.5 months in group II, 67 of 92 pts (72.8%) and 49 of 75 pts available to follow up (65.3%; p = 0.221) were free of atrial tachyarrhythmia, respectively. Phrenic nerve palsy occurred in 5.4% of the pts in group I (5/92 pts) and 1.3% of the pts in group II (1/77 pts; p = 0.22). Both the mean nadir temperatures of the bonus freezes and mean nadir temperatures of the isolation freezes differed significantly between the recurrent and non-recurrent pts in group I. The predilection sites of the reconduction for both groups were the inferior aspect of the inferior pulmonary veins.ConclusionThe impact of a bonus freeze on long-term clinical outcome was not significant for two reasons: 1) The necessity of a bonus freeze was low because the long-term clinical success rate without a bonus freeze was high; and 2) the majority of bonus freezes, especially at the predilection sites, such as the inferior PV, appeared to be ineffective.

Abstract No. 448 Bronchial artery embolization for hemoptysis in cystic fibrosis patients

Over the past 20 years, there has been significant improvement in the treatment of cystic fibrosis (CF), which has prolonged survival from the second decade, well into the fourth decade of life. We sought to evaluate short, medium, and long-term outcomes of bronchial artery embolization (BAE) in this population. Between January 2001 and April 2018, 242 patients with cystic fibrosis presented to our institution with hemoptysis. Thirty-eight BAEs were performed on 28 patients. Outcomes were examined at 30 days, 1 year, and 3 years and reported as technical success rates (no repeat embolization or death from hemoptysis) and clinical success rates (no repeat embolization or death from any cause). Thirty-day complication and overall mortality rates were evaluated. Mean patient age for BAE was 32 years old and median follow up was 4.8 years (range 10 months to 16.7 years). Within 30 days, short-term technical and clinical success rates were 89.3% (25/28 patients) and 82.1% (23/28) respectively; three patients had repeat embolization, 1 patient died of hemoptysis, and 1 patient died of multiorgan system failure. One year technical and clinical success rates were 85.7% (24/28) and 78.6% (22/28); an additional patient had repeat embolization at 44 days and again at 7 months. The 3-year technical and clinical success rates were 82.1% (23/28) and 75% (21/28); an additional patient had repeat embolization at 1 year 10 months. The thirty-day complication rate was 10.5% (4/38 BAEs) and included a death due to massive hemoptysis 2 hours after BAE, femoral artery access site thrombosis, transient chest pain, and transient odynophagia. Overall 3-year mortality rate was 25% (7/25). BEA is a safe and effective procedure with low complication rates and is a potentially life saving intervention. BEA has high long-term technical and clinical success rates for controlling hemoptysis in cystic fibrosis patients. Repeat embolization is necessary in some patients.