Procedure-associated Complications Research Articles

Transobturator-cable-fixation in pelvic ring injuries with symphyseal disruption - a last resort?

The role of transobturator-cable-fixation (TOCF) in traumatic symphyseal rupture of the pelvic ring remains unclear. This case series aims to evaluate TOCF in complex and revision cases in pelvic surgery. A retrospective analysis of a chronological case series was conducted, studying pelvic fractures stabilized using TOCF between January 2006 and December 2022. The variables considered included age, gender, fracture classification, Injury Severity Score (ISS), Body Mass Index (BMI), trauma mechanism, time to surgery, fixation technique, hospital duration, complications, status on discharge (Glasgow Outcome Scale; GOS), follow-up time and indication for the use of TOCF. All patients (N = 7) were male with a mean age of 64 years and a mean BMI of 29. The mean ISS was 45, with the lowest ISS of 25, indicating that only polytraumatized patients were included. Two anterior-posterior-compression-, four lateral-compression-, and one vertical-shear-pelvic-injury were identified. TOCF was added in six cases to support symphyseal plating and in one case to external fixation. The mean hospital stay was 49 days and the mean follow-up duration was 8.5 months. No complications associated with TOCF were observed during the surgical procedure or follow-up. TOCF showed no procedure-associated complications and effectively supported symphyseal healing in all cases. The main indications were obesity, poor bone quality in elderly patients, and revision cases. TOCF could be considered as a last treatment option in open-book pelvic injuries where plating or external fixation is at risk to fail.

Association Between Documented Intraoperative and Postoperative Adverse Events: An Analysis of Over 100,000 Surgical Trauma Cases

Abstract Background Intraoperative adverse events (iAEs) are common during surgical procedures. However, structured and comparable documentation often depends on the physician’s subjective assessment of each iAE. Aims The aim of this study was to validate the hypothesis that iAEs during surgical interventions are clearly associated with further postoperative complications and prolonged hospital stays. Methods We performed a retrospective analysis comparing surgical patients with and without any iAEs regarding postoperative outcomes during the hospitalization. We analyzed more than 100,000 patients with surgically treated injuries between January 2012 and December 2022 from over 70 institutions across Switzerland. Outcome parameters were further compared using a 1:1 case-control matching method, while controlling for same age, gender, main diagnosis and procedure. Results Regarding outcomes, patients with iAEs had a significantly longer duration of surgery (131 vs. 77 minutes), a prolonged length of hospital stay (10 vs. 8 days), a significantly higher need for an intensive care unit (ICU) stay of more than one day (7% vs. 3%), and a significantly higher rate of postoperative and procedure-associated complications (28% vs. 7%) than those without iAEs. The prolonged duration of surgery, length of stay, and postoperative and procedure-associated complications in the iAE group were also confirmed in the matched-pair analysis to be associated with poorer patient outcomes while controlling for significant characteristics. Conclusion In line with the current literature, our data show a clear relevance of iAEs as crucial factors for patient outcomes, manifesting in significantly longer durations of surgery, prolonged lengths of stay, and more postoperative complications, in a broad spectrum of surgical trauma procedures. We propose the mandatory documentation of iAEs through a standardized classification system, such as ClassIntra, and in accordance with the Intraoperative Complications Assessment and Reporting with Universal Standards (ICARUS) guidelines for clinical practice and surgical research.

Pre- and post-procedural cardiac imaging (computed tomography and magnetic resonance imaging) in electrophysiology: a clinical consensus statement of the European Heart Rhythm Association and European Association of Cardiovascular Imaging of the European Society of Cardiology.

Imaging using cardiac computed tomography (CT) or magnetic resonance (MR) imaging has become an important option for anatomic and substrate delineation in complex atrial fibrillation (AF) and ventricular tachycardia (VT) ablation procedures. Computed tomography more common than MR has been used to detect procedure-associated complications such as oesophageal, cerebral, and vascular injury. This clinical consensus statement summarizes the current knowledge of CT and MR to facilitate electrophysiological procedures, the current value of real-time integration of imaging-derived anatomy, and substrate information during the procedure and the current role of CT and MR in diagnosing relevant procedure-related complications. Practical advice on potential advantages of one imaging modality over the other is discussed for patients with implanted cardiac rhythm devices as well as for planning, intraprocedural integration, and post-interventional management in AF and VT ablation patients. Establishing a team of electrophysiologists and cardiac imaging specialists working on specific details of imaging for complex ablation procedures is key. Cardiac magnetic resonance (CMR) can safely be performed in most patients with implanted active cardiac devices. Standard procedures for pre- and post-scanning management of the device and potential CMR-associated device malfunctions need to be in place. In VT patients, imaging-specifically MR-may help to determine scar location and mural distribution in patients with ischaemic and non-ischaemic cardiomyopathy beyond evaluating the underlying structural heart disease. Future directions in imaging may include the ability to register multiple imaging modalities and novel high-resolution modalities, but also refinements of imaging-guided ablation strategies are expected.

Simultaneous transapical transcatheter aortic and mitral valve replacement in patients with severe valve dysfunction: initial experience.

Simultaneous transcatheter mitral valve in valve (VIV) replacement and aortic valve replacement experience is limited. We report our initial experience with simultaneous transapical transcatheter aortic and mitral valve replacement in patients with severe valve dysfunction. A total of 8 patients had simultaneous transcatheter heart valve implants for severe mitral bioprosthesis failure (VIV), with a second valve procedure that included native aortic regurgitation (n = 3) or degenerated bioprostheses in the aortic position (n = 5). All patients were treated with a self-expandable J-valve transcatheter valve, using the transapical approach. The mean age of the patients was 73.1 ± 6.2years. The mean Society of Thoracic Surgeons score was 13.8 ± 6.3%. Device success was 100% according to Valve Academic Research Consortium-2 criteria. No other procedure-associated complications occurred, including left ventricular outflow tract obstruction and valve migration. The mean hospital lengths of stay after the procedure were 11.5 ± 8.0days. No deaths occurred at 30days. At a median follow-up period of 28.7 ± 22.3months, no patients died. All patients were in New York Heart Association functional classes I-II. Echocardiographic parameters at follow-up showed a normofunctioning J valve in the mitral position and a mean max mitral flow velocity of 2.0 ± 0.5m/s; the J valve in the aortic position was also normofunctioning, and the mean max aortic flow velocity was 2.3 ± 0.5m/s. Simultaneous transapical transcatheter aortic and mitral valve replacement using the self-expandable J valve appears to be a feasible and effective alternative to redo surgery.

Pulmonary Vein Isolation in Elderly Patients ≥ 75 Years: A Propensity Score-Matched Analysis With Focus on Differences Among Atrial Fibrillation Types

BackgroundAge is a major risk factor for development of atrial fibrillation (AF) and associated with increased recurrence rates in the setting of rhythm control. Current data tend to support catheter ablation in elderly patients, but uncertainties exist regarding efficacy and safety of ablation in elderly patients. MethodsThis was a prospective single-centre observational study with propensity score matching (PSM) to investigate the influence of age on efficacy and safety of cryoballoon ablation (CBA) stratified by age (< 75 years vs ≥ 75 years) and AF phenotype (paroxysmal vs persistent). Primary efficacy endpoint was recurrence of atrial arrhythmia after a 90-day blanking period. Safety endpoints were death, stroke, or procedure-associated complications. ResultsConsecutive patients (n = 953) underwent CBA for first-time AF ablation. Median follow-up was 18 months. By means of PSM, 268 matches were formed. At 1 year, primary efficacy endpoint occurred in 22.4% of young vs 33.2% of elderly patients, including both AF phenotypes (hazard ratio [HR], 0.65; 95% confidence interval [CI], 0.47-0.90; P = 0.01). AF relapse occurred in 19.7% of young vs 28.5% of elderly patients with paroxysmal (HR, 0.63; 95% CI, 0.40-0.99; P = 0.046) compared with 25.9% (30 of 116, young) vs 38.8% (45 of 116, elderly) patients with persistent AF (HR, 0.62; 95% CI, 0.39-0.97; P = 0.038). No difference was observed regarding the incidence of safety endpoints between young and elderly patients (P = 0.38). ConclusionsCBA is associated with higher recurrence rates in elderly (≥ 75 years) than in younger patients, with highest recurrence rates in elderly patients with persistent AF.

Stepwise Approach for Transvenous Lead Extraction in a Large Single Centre Cohort.

Infection, lead dysfunction and system upgrades are all reasons that transvenous lead extraction is being performed more frequently. Many centres focus on a single method for lead extraction, which can lead to either lower success rates or higher rates of major complications. We report our experience with a systematic approach from a less invasive to a more invasive strategy without the use of laser sheaths. Consecutive extraction procedures performed over a period of seven years in our electrophysiology laboratory were included. We performed a stepwise approach with careful traction, lead locking stylets (LLD), mechanical non-powered dilator sheaths, mechanical powered sheaths and, if needed, femoral snares. In 463 patients (age 69.9 ± 12.3, 31.3% female) a total of 780 leads (244 ICD leads) with a mean lead dwelling time of 5.4 ± 4.9 years were identified for extraction. Success rates for simple traction, LLD, mechanical non-powered sheaths and mechanical powered sheaths were 31.5%, 42.7%, 84.1% and 92.6%, respectively. A snare was used for 40 cases (as the primary approach for 38 as the lead structure was not intact and stepwise approach was not feasible) and was successful for 36 leads (90.0% success rate). Total success rate was 93.1%, clinical success rate was 94.1%. Rate for procedural failure was 1.1%. Success for less invasive steps and overall success for extraction was associated with shorter lead dwelling time (p < 0.001). Major procedure associated complications occurred in two patients (0.4%), including one death (0.2%). A total of 36 minor procedure-associated complications occurred in 30 patients (6.5%). Pocket hematoma correlated significantly with uninterrupted dual antiplatelet therapy (p = 0.001). Pericardial effusion without need for intervention was associated with long lead dwelling time (p = 0.01) and uninterrupted acetylsalicylic acid (p < 0.05). A stepwise approach with a progressive invasive strategy is effective and safe for transvenous lead extraction.

Dysbiosis of gut microbiota in patients with protein-losing enteropathy after the Fontan procedure

BackgroundThere is a lack of predictive biomarkers for the onset or activity of protein-losing enteropathy (PLE), a Fontan procedure-associated complication. Here, we aimed to identify the gut microbiota composition of patients with active PLE and investigate its relationship with PLE activity. MethodsThis multicenter case–control study involved patients who developed PLE (n = 16) after the Fontan procedure and those who did not (non-PLE; n = 20). Patients with PLE who maintained a serum albumin level of ≥3 g/dL for >1 year were included in the remissive-stage-PLE group (n = 9) and those who did not maintain this level were included in the active-PLE group (n = 7). 16S rRNA gene sequencing analysis of fecal samples was performed using QIIME2 pipeline. Alpha (Shannon and Faith's phylogenetic diversity indices) and beta diversity was assessed using principal coordinate analysis based on unweighted UniFrac distances. ResultsShannon and Faith's phylogenetic diversity indices were lower in the active-PLE group than in the remissive-stage- (q = 0.028 and 0.025, respectively) and non-PLE (q = 0.028 and 0.017, respectively) groups. Analysis of beta diversity revealed a difference in the microbiota composition between the active-PLE and the other two groups. Linear discriminant effect size analysis demonstrated differences in the relative abundance of Bifidobacterium and Granulicatella spp., and Ruminococcus torques between patients with active- and those with remissive-stage-PLE. ConclusionsGut microbiota dysbiosis was observed in patients with active PLE. Changes in the bacterial composition of the gut microbiota and decreased diversity may be associated with the severity of PLE.

Feasibility Analysis of Ultrasound-Guided Placement of Tunneled Hemodialysis Catheters

Radiographic fluoroscopy is the current standard for placement of tunneled central venous catheters (CVCs) for hemodialysis. Radiographic fluoroscopy requires structural and personnel infrastructure and exposes the patient to ionizing radiation. Here, we investigate the feasibility of solely ultrasound-guided placement of tunneled central venous dialysis catheters (USCVCs). We evaluated prospectively collected single-center data regarding safety and catheter function of 134 consecutive patients who underwent USCVC implantation between 2020 and 2021. We used the inset guidewire to visualize the position of the catheter tip. In the case of inadequate visibility by ultrasound, we used intracardiac electrocardiography (ECG) recording or agitated saline. A total of 1844 catheter days were assessed. The optimal CVC position was defined as being within the upper right atrium (URA) and middle to deep right atrium. Of the 134 USCVCs, 87% were placed on the right side. The primary success rate for optimal tip position and catheter function was 98%. Of the USCVCs, 97% were placed solely by ultrasound. Regarding positioning, 6% were in the vena cava superior zone, 70% in the URA and 24% in the middle to deep right atrium, resulting in a rate of 94% with optimal positioning. Effective blood flow averaged 292 ± 39 ml/min. There were no immediate procedure-associated complications. Placement of CVC for hemodialysis solely by ultrasound is an effective alternative to fluoroscopy-assisted placement.

Cryoballoon pulmonary vein isolation for atrial fibrillation in obese patients: A non-inferiority analysis

BackgroundPatients with obesity are at higher risk of developing atrial fibrillation (AF) and benefit from radiofrequency ablation. Potentially, cryoballoon ablation (CBA) may be equally effective and safe in such patients. MethodsWe conducted a prospective, single-center study to investigate whether CBA for pulmonary vein isolation is as effective and safe in obese patients as it is in non-obese controls. Primary efficacy endpoint was recurrence of AF, atrial flutter or atrial tachycardia after a 90-day blanking period. Safety endpoints were death, stroke or procedure-associated complications. Conduction of a subgroup analysis regarding the impact of additional diabetes was predefined in case the primary efficacy endpoint was met. The study was event driven and powered for noninferiority. ResultsA total of 949 patients underwent CBA (251 obese with mean body-mass-index 33.5 ± 3 kg/m2 and 698 non-obese with mean body-mass-index 25.3 ± 3 kg/m2) during a 5-year recruitment period. Median follow-up was 15 months. The primary efficacy endpoint occurred in 78/251 obese and 247/698 non-obese patients (12-months Kaplan-Meier event-rate estimates, hazard ratio 0.79; 95% confidence interval [CI], 0.58 to 1.07; log-rank P = 0.0002 for noninferiority). No differences were observed in safety end point occurrence (P = 0.78). The occurrence of primary efficacy end point was found to be unaffected by the presence of diabetes in the prespecified subgroup analysis (log-rank P = 0.57). ConclusionCBA is effective and safe in obese and DM patients. Weighing the high cardiovascular risk of obese patients against a reduction of cardiovascular events by early rhythm control, CBA should be offered to this patient population.

Medial augmentation plating of aseptic distal femoral nonunions

BackgroundDistal femur nonunions are well-recognized contributors to persistent functional disability, with limited data regarding their treatment options. In the current study, we asked whether additional medial augmentation plating is a feasible treatment option for patients with aseptic distal femoral nonunion and intact lateral implants.MethodsWe conducted a single-center, retrospective study including 20 patients treated for aseptic distal femoral nonunion between 2002 and 2017. The treatment procedure included a medial approach to the distal femur, debridement of the nonunion site, bone grafting and medial augmentation plating utilizing a large-fragment titanium plate. Outcome measures were bone-related and functional results, measured by the Hospital for Special Surgery Knee Rating Scale (HSS) and the German Short Musculoskeletal Function Assessment questionnaire (SMFA-D).ResultsEighteen of 20 nonunions showed osseous healing at 8.16 ± 5.23 (range: 3–21) months after augmentation plating. Regarding functional results, the mean HSS score was 74.17 ± 11.12 (range: 57–87). The mean SMFA-D functional index was 47.38 ± 16.78 (range 25.74–71.32) at the last follow-up. Index procedure-associated complications included two cases of persistent nonunion and one case of infection.ConclusionsAccording to the assessed outcome measures, augmentation plating is a feasible treatment option, with a high proportion of patients achieving bony union and good functional outcomes and a few patients experiencing complications.

Clinical outcomes of esophageal granular cell tumors with different endoscopic resection methods

Esophageal granular cell tumors (GCTs), the second most common subepithelial tumors (SETs) of the esophagus, are potentially malignant with no definite management guidelines available. We retrospectively enrolled 35 patients with endoscopically resected esophageal GCTs between December 2008 and October 2021 and evaluated the clinical outcomes from the various methods performed. Several modified endoscopic mucosal resections (EMRs) were performed for treating esophageal GCTs. Clinical and endoscopic outcomes were evaluated. Mean age of patients was 55.8 ± 8.2, with majority being men (57.1%). Mean tumor size was 7.2 ± 2.6 mm, most (80.0%) were asymptomatic and present in the distal third of the esophagus (77.1%). Endoscopic characteristics predominantly included broad-based (85.7%) and whitish-to-yellowish color changes (97.1%). Endoscopic ultrasound (EUS) of 82.9% of the tumors revealed homogeneous hypoechoic SETs originating from the submucosa. The five endoscopic treatment methods used were: ligation-assisted (77.1%), conventional (8.7%), cap-assisted (5.7%), and underwater (5.7%) EMRs and ESD (2.9%). Mean procedure time was 6.6 ± 2.1 min, and no procedure-associated complications were noted. The en-bloc and complete histologic resection rates were 100% and 94.3%, respectively. No recurrences were noted during follow-up, and no significant differences in the clinical outcomes of the different methods of endoscopic resection were found. Based on tumor characteristics and therapeutic outcomes, modified EMR methods can be effective and safe. However, there were no significant differences in the clinical outcomes of the different methods of endoscopic resection.

#4216 FEASIBILITY ANALYSIS OF AN ULTRASOUND-GUIDED PLACEMENT OF TUNNELED HEMODIALYSIS CATHETERS

Abstract Background and Aims Radiographic fluoroscopy (RAD) is the current standard for placement of tunneled central venous catheters (CVC) for hemodialysis. RAD requires structural and personnel infrastructure and exposes the patient to ionizing radiation. Here, we investigate the feasibility of solely ultrasound-guided placement of tunneled central venous dialysis catheters. Method We evaluated prospectively collected single center data of 134 consecutive patients who underwent CVC implantation between 2020 and 2021 regarding feasibility, safety, and catheter function. We used the inset guidewire to visualize the position of the catheter tip. In the case of inadequate visibility by ultrasound, we additionally used intracardiac ECG recording or agitated saline. A total of 1844 catheter days were assessed. As a historical control, we analyzed the position of 50 CVCs placed by RAD. Optimal CVC position was defined to be in between the cavoatrial junction (CAJ) and the right atrium (RA), according to the guidelines. Results The catheters were placed on the right side in 117 (87%) cases. The primary success rate for optimal position and function was 97,7% (n = 131). Placement solely by ultrasound was possible in 130 (97%) cases. There were no immediate procedure-associated complications related to the new technique. Effective blood flow averaged 292 +/- 39 ml/min. Of all ultrasound-placed catheters, 6% were in the vena cava superior (RAD 24%), 70% in the CAJ (RAD 60%), and 24% in the RA (RAD 16%), resulting in a rate of 94% with optimal position. Conclusion Placement of CVCs for hemodialysis solely by ultrasound is an effective and safe alternative to fluoroscopy-assisted placement.

Robot-assisted spinal augmentation procedures: is it worth the increased effort?

Spinal augmentation procedures (SAP) are standard procedures for vertebral compression fractures. Often, SAPs are carried out in a minimally invasive, percutaneous way. Certain anatomic conditions such as small pedicles or kyphotic deformities resulting from a significant collapse of the vertebral body might render the operation more difficult and increase the risk of complications. Thus, robot assistance might be useful to optimize the trajectory and to reduce procedure-associated complications. In this study robot-assisted percutaneous SAPs are compared with conventional fluoroscopy-guided percutaneous SAP. A retrospective observational analysis was carried out. Standard demographic parameters were analyzed. Procedural data including radiation dosage records were screened. Biomechanical data were recorded. Cement volumes were analyzed. The precision of the pedicular trajectory was reviewed, and misplaced trajectories were categorized. Procedure-associated complications were analyzed and evaluated for their clinical significance. A total of 130 procedures were reviewed, and 94 patients were finally included. Osteoporotic fractures (OF) were the main indication (60.7%; OF 2-44%, OF 4-33%). Demographic parameters and clinically relevant complications were equally distributed between the two groups. Duration of surgery was significantly longer in robot-assisted procedures (p < 0.001). Intraoperative radiation exposure was equally distributed. Injected cement volume was similar in both groups. There was no significant difference in pedicle trajectory deviation. The use of robot assistance in SAP seems not to be superior with regard to accuracy, radiation exposure and the rate of complications when compared to fluoroscopy-guided SAP.

Effect of periprocedural furosemide-induced diuresis with matched isotonic intravenous hydration in patients with chronic kidney disease undergoing transcatheter aortic valve implantation.

Acute kidney injury (AKI) after transcatheter aortic valve implantation (TAVI) is a serious complication which is associated with increased mortality. The RenalGuard system was developed to reduce the risk of AKI after contrast media exposition by furosemide-induced diuresis with matched isotonic intravenous hydration. The aim of this study was to examine the effect of the RenalGuard system on the occurrence of AKI after TAVI in patients with chronic kidney disease. The present study is a single-center randomized trial including patients with severe aortic valve stenosis undergoing TAVI. Overall, a total of 100 patients treated by TAVI between January 2017 and August 2018 were randomly assigned to a periprocedural treatment with the RenalGuard system or standard treatment by pre- and postprocedural intravenous hydration. Primary endpoint was the occurrence of AKI after TAVI, and secondary endpoints were assessed according to valve academic research consortium 2 criteria. Overall, the prevalence of AKI was 18.4% (n = 18). The majority of these patients developed mild AKI according to stage 1. Comparing RenalGuard to standard therapy, no significant differences were observed in the occurrence of AKI (RenalGuard: 21.3%; control group: 15.7%; p = 0.651). In addition, there were no differences between the groups with regard to 30-day and 12-month mortality and procedure-associated complication rates. In this randomized trial, we did not detect a reduction in AKI after TAVI by using the RenalGuard system. A substantial number of patients with chronic kidney disease developed AKI after TAVI, whereas the majority presented with mild AKI according to stage 1 (ClinicalTrials.gov number NCT04537325).

Safety and Efficacy of Liver Venous Deprivation Following Transarterial Chemoembolization Before Major Hepatectomy for Hepatocellular Carcinoma.

This study aimed to evaluate the safety and efficacy of liver venous deprivation (LVD) following transarterial chemoembolization (TACE) in patients with hepatocellular carcinoma (HCC). Between January 2021 and December 2022, HCC patients indicated for hepatectomy with initial insufficient future liver remnant (FLR) underwent LVD after TACE to induce preoperative liver hypertrophy. Twenty-seven HCC patients with a median age of 55 years underwent LVD. No TACE or LVD procedure-associated complications occurred, except for 1 case presenting with grade A liver failure after LVD (then recovered after 7 days). The FLR volume was 29.3% (interquartile range [IQR] = 7.5) and 48.9% (IQR = 8.6) of the total liver volume before and after LVD, respectively (p < 0.001). The degree of hypertrophy and FLR hypertrophy rate were 14.8% (IQR = 8.4) and 55.2% (IQR = 36.7), respectively. All 27 patients demonstrated sufficient FLR after LVD (24 patients at three weeks post-LVD, one at six weeks, and two at ten weeks), but only 21 patients accepted surgery. Postoperative histopathology showed 16 patients with cirrhosis and five with mild fibrosis (F1, F2). One patient presented with severe intraoperative bleeding due to damage of left hepatic vein and developed grade C liver failure, then died on day 32 postoperation. LVD following TACE seems to be a safe, effective, and feasible method of inducing significant FLR regeneration in HCC, even in well-selected cirrhotic livers. Comparative studies with a large patient population and multicenter data are needed for further evaluation.

Fourth ventricular subarachnoid stent for Chiari malformation type I-associated persistent syringomyelia.

Syringomyelia (syrinx) associated with Chiari malformation type I (CM-I) is commonly managed with posterior fossa decompression, which can lead to resolution in most cases. A persistent syrinx postdecompression is therefore uncommon and challenging to address. In the setting of radiographically adequate decompression with persistent syrinx, the authors prefer placing fourth ventricular subarachnoid stents that span the craniocervical junction particularly when intraoperative observation reveals arachnoid plane scarring. The objective of this study was to evaluate the safety and efficacy of a fourth ventricle stent for CM-I-associated persistent syringomyelia, assess dynamic changes in syrinx dimensions, and report stent-reduction durability, clinical outcomes, and procedure-associated complications. The authors performed a single-institution, retrospective review of patients who underwent fourth ventricular subarachnoid stent placement for persistent CM-I-associated syringomyelia following a prior posterior fossa decompression. The authors' institutional Chiari database contains 600 cases with 149 decompressions for CM-I-associated syringomyelia, of which 13 met criteria for inclusion. Data on patient demographics, clinical presentation and outcomes, and MRI findings were collected. The maximal syrinx diameter was estimated by calculating the area of an elliptical cross-section in the largest axial plane from preoperative, immediately postoperative, and late postoperative T2-weighted MR images. All 13 patients experienced a significant decrease in mean syrinx area from the preoperative to the late postoperative MRI (mean syrinx diameter 114.1 ± 81.8 mm2 vs 24.5 ± 23.8 mm2, p < 0.001). The mean time until late postoperative MRI was 19.7 months (range 2.0-70.7 months). The syrinx area reduced on average by 75.0% ± 23.9% at the time of the last postoperative scan. Syrinx resolution was variable, with 4 patients (30.8%) achieving near-complete resolution (> 90%, grade III reduction), 7 patients (50%) having 50%-90% reduction (grade II), and 2 patients (14.3%) having < 50% decrease (grade I). One patient experienced catheter migration into the left brachium pontis with an associated cyst at the tip of the catheter that decreased in size on follow-up imaging. Placement of fourth ventricular subarachnoid stents spanning the craniocervical junction in patients with persistent CM-I-associated syringomyelia after posterior fossa decompression is a safe therapeutic option and significantly reduced the mean syrinx area, with a greater reductive effect seen over longer follow-up periods.

Abstract 12854: Strategies and Outcomes of Patients With Severely Reduced Ejection Fraction (≤15%) Undergoing Transvenous Lead Extraction: A Single Center Experience

Introduction: Patients with severely reduced EF (SREF≤15%) are deferred from transvenous lead extraction (TLE) due to fears of intraoperative hemodynamic collapse. When these patients require lead extraction, their management options are limited, and they suffer high morbidity and mortality. Left ventricular assist devices may provide intraoperative hemodynamic support and facilitate TLE, enabling life-saving interventions. Hypothesis: We present our single-center experience performing TLE in 245 patients with SREF. Additionally, we report the outcomes of 8 patients who received left ventricular support during TLE. Methods: Between January 2008-January 2022, we performed TLE on 245 patients with Stage D heart failure, SREF, and Class I or II indications for extraction. Primary (clinical success and in-hospital mortality) and secondary outcomes (length of stay [LOS] and procedure-associated complications) were compared between SREF patients and control. A subgroup analysis was performed in the SREF group to evaluate the outcomes of eight patients who underwent extraction with LV assist devices. Results: Overall clinical success was high (97.6%), and mortality was low (5.3%). There were no statistically significant differences in primary outcomes associated with extraction between groups. Similarly, there were no significant differences in procedural complications between groups. In the SREF group, there were no significant differences in outcomes between the eight patients undergoing TLE with LV assist devices and cases that did use LV assist devices. Conclusions: Lead extraction in patients with SREF can be performed safely and effectively. Adopting a few simple steps, including initiating LV support, can overcome myocardial impairment in patients who decompensate.

Persistent Atrial Fibrillation in Elderly Patients: Limited Efficacy of Pulmonary Vein Isolation.

(1) Background: Cryoballoon pulmonary vein isolation (cryoPVI) is established for symptomatic paroxysmal atrial fibrillation (AF) treatment, but its value in persistent AF is less clear. In particular, limited data are available on its efficacy in elderly patients (≥75 years) with persistent AF. Age is an important modifier of AF progression and represents a risk-factor for AF recurrence. (2) Methods: Prospective, single-center observational study to evaluate the impact of age on efficacy and safety of cryoPVI in elderly patients. Primary efficacy endpoint was symptomatic AF recurrence after 90-day blanking period. Primary safety endpoints were death from any cause, procedure-associated complications or stroke/transient ischemic attack. Median follow-up was 17 months (range 3–24). (3) Results: We included 268 patients with persistent AF (94 ≥ 75 years of age). Multivariate Cox regression analysis identified age as the only independent factor influencing AF recurrence in the overall cohort (p = 0.006). To minimize confounding bias in efficacy and safety analysis of cryoPVI, we matched younger and elderly patients with respect to baseline characteristics. At 24 months, primary efficacy endpoint occurred in 13/69 patients <75 years and 31/69 patients ≥75 years of age (24 months Kaplan–Meier event-rate estimates, HR 0.34; 95% CI, 0.19 to 0.62; log-rank p = 0.0004). No differences were observed in the occurrence of safety end points. (4) Conclusions: Elderly (≥75 years) patients with persistent AF undergoing cryoPVI had an approximately threefold higher risk of symptomatic AF recurrence than matched younger patients. Accordingly, other treatment modalities may be evaluated in this population.

Neoadjuvant immunoradiotherapy in patients with locally advanced oral cavity squamous cell carcinoma: a retrospective study.

Although anti-programmed death receptor-1 (PD-1) agents have been evaluated in the neoadjuvant setting for the treatment of locally advanced head and neck cancer, including oral cavity squamous cell carcinoma (OCSCC), the overall response rate is modest. The aim of the present study was to evaluate the efficacy and safety of neoadjuvant nivolumab in combination with stereotactic body radiotherapy (SBRT) for the treatment of locally advanced OCSCC. OCSCC patients who underwent surgical resection within 6months of treatment with nivolumab plus SBRT from December 2018 to February 2021 were analyzed retrospectively. All 30 eligible patients enrolled in this study well tolerated the neoadjuvant treatment with no serious adverse events (AEs). Of them, 27 patients (90.0%) achieved R0 resection, and 5 patients (16.7%) experienced procedure-associated complications. The complete response (CR), partial response (PR) and stable disease (SD) were 10.0%, 46.7% and 43.3% respectively. The major pathological response (MPR), complete pathological response (pCR) and clinical to pathological downstaging rate were 60.0%, 33.3% and 83.3% respectively. During the median follow-up period of 13.5months, 26 patients (86.7%) who underwent surgical resection remained alive. The disease-free survival (DFS) and overall survival (OS) at 24months were 70.4% and 76.4% respectively. Neoadjuvant nivolumab plus SBRT is safe and efficacious, and could be used as a potential neoadjuvant option for the treatment of patients with locally advanced OCSCC.

Effectiveness and Safety of CT-Guided Facet Joint Cyst Rupture for Radicular Pain as First Choice Therapy: A Retrospective Analysis.

To evaluate effectiveness and safety of computed tomography (CT)-guided cyst rupture with intraarticular contrast-enhanced injection of steroid and local anesthetic as first choice therapy in patients with facet joint cyst-induced radicular pain. Retrospective data set analysis. University hospital. One hundred and twenty-one patients suffering from radicular pain attributable to facet joint cysts were included. The rate of patients without following surgery was assessed and defined as surrogate to measure effectiveness. Patients' characteristics, procedure-associated complications, technical aspects, and imaging findings on magnetic resonance imaging (MRI) were analyzed. A subgroup of 65 patients (54%) underwent telephone interview to assess pain relief and clinical outcome measured by Numeric Rating Scale and Oswestry Disability Index. Analyses between the groups with and without surgery were performed by Fisher exact test and two-sample unpaired t-test, respectively. The effectiveness of CT-guided cyst rupture was found to be 66.1%. Procedure-induced pain yielded in premature abort in two cases (1.7%). The detection of epidural contrast agent was statistically significantly associated with no need for surgery (P = .010). The cyst level was associated with the status of following surgery (P = .026), that is, cysts at lower lumbar spine were easier to rupture than cysts at other locations (cervical, thoracic, or upper lumbar spine). No further significant association was found. CT-guided cyst rupture as the first-choice therapy in patients with cyst-induced radicular pain was safe and effective. Successful cyst rupture was associated with no need for surgery. Cysts at lower lumbar spine revealed the highest success rate.