Procedure-related Adverse Events Research Articles

Endovascular Denervation for the Improvement of Limb Ischemia in Patients with Peripheral Artery Disease: A Randomized Clinical Trial

ObjectivesTo evaluate the safety and efficacy of endovascular denervation (EDN) as an adjunct to percutaneous vascular intervention (PVI) for peripheral artery disease (PAD). MethodsFrom August 2019 to April 2021, 38 eligible patients with PAD enrolled in this study were randomly and equally assigned into two groups: the PVI group and the PVI+EDN group treated with EDN at the iliac and femoral arteries before PVI. The primary endpoint was the improvement in the ankle brachial index (ABI) at 6 months after the procedure. The secondary endpoints were transcutaneous oxygen pressure (TcPO2), Rutherford category, numerical rating scale (NRS) score, and safety. ResultsThe technical success rates of PVI and EDN were 100%, and no device- or procedure-related major adverse events occurred in either group. Compared with PVI alone, PVI+EDN demonstrated a significant improvement in limb hemodynamics at 6 months (ΔABI 0.44 ± 0.31 vs. 0.24 ± 0.15, P = 0.018). Microcirculatory perfusion of PAD was significantly better at 6 months in the PVI+EDN group (ΔTcPO2, 15.68 ± 16.72 vs. 4.95 ± 13.43, P = 0.036). The Rutherford category was significantly improved in the PVI+EDN group in comparison with the PVI group at the 3-month follow-up (100.00% vs. 68.42%, P = 0.02). The decrease in the NRS score in the PVI+EDN group was greater than that in the PVI group at 1 week following the procedure (3 [2-5] vs. 4 [4-6], P = 0.022). ConclusionIn this single-center pilot analysis of a heterogeneous cohort of patients with PAD, PVI with EDN demonstrated a significant improvement in limb ischemia at 6 months compared with PVI alone.

A Multi-Institutional Safety and Feasibility Study Exploring the Use of Hydrogel to Create Spatial Separation between the Pancreas and Duodenum in Patients with Pancreatic Cancer

IntroductionThe administration of dose-escalated radiation for pancreatic adenocarcinoma remains challenging due to the proximity of dose-limiting stomach and bowel, particularly the duodenum for pancreatic head tumors. We explore whether endoscopic injection of a temporary, absorbable hydrogel into the pancreatico-duodenal (PD) groove is safe and feasible for the purpose of increasing spatial separation between pancreatic head tumors and the duodenum. MethodsSix patients with localized pancreatic adenocarcinoma underwent endoscopic injection of hydrogel into the PD groove. Safety was assessed based on the incidence of procedure-related adverse events resulting in a delay of radiation therapy initiation. Feasibility was defined as the ability to create spatial separation between the pancreas and duodenum, as assessed on simulation CT. ResultsAll six patients were able to undergo endoscopic injection of hydrogel into the PD groove. No device-related events were experienced at any point in follow-up. Presence of hydrogel in the PD groove was apparent on simulation CT in all six patients. Mean space created by the hydrogel was 7.7 mm +/- 2.4 mm. In three patients who underwent Whipple resection, presence of hydrogel in the PD groove was pathologically confirmed with no evidence of damage to the duodenum. ConclusionsEndoscopic injection of hydrogel into the PD groove is safe and feasible. Characterization of the dosimetric benefit that this technique may offer in the setting of dose-escalated radiation should also be pursued, as should the ability of such dosimetric benefit to translate into clinically improved tumor control.

PP81 Efficacy Of Transcranial Direct Current Stimulation For Depressive Episode Disorders

IntroductionDepression is a general term that describes different depressive disorders which are highly prevalent and disabling, characterized by decreases in quality of life. Transcranial Direct Current Stimulation (tDCS) is a non-invasive brain modulation technique used, among other purposes, for the treatment of chronic pain and headache. In order to clarify the effect of this stimulation on depressive disorders, the objective of this review was to evaluate efficacy and safety of treatment with tDCS for depressive disorders.MethodsA systematic research study was carried out on 30 June 2022 in MEDLINE (by Pubmed), Embase, Literatura Latino-Americana e do Caribe em Ciências da Saúde (LILACS), PsycInfo e Global Mental Health databases. Were included systematic reviews (SR) with meta-analysis that selected patients with depression, in use of tDCS, using as comparator sham stimulation (placebo) or any other treatment (pharmacologic or no) or any comparison between pre-and post-intervention.ResultsEight SR with meta-analysis of randomized clinical trials (RCTs) on the efficacy and safety of tDCS in the treatment of depressive disorders were retrieved. Subjects were assessed for clinical response, remission, change in scores on depression scales, occurrence of procedure-related adverse events, and treatment dropout. Three systematic reviews showed results that point to the effectiveness of tDCS for the clinical response outcome and one considering the remission outcome. As for the outcome measured by the change in depression scale scores, all included reviews showed favorable results for tDCS. It is noteworthy that the studies included in the reviews have methodological limitations. With regard to safety, an increased risk treatment-emergent mania or hypomania (TEM) has been observed.ConclusionsThe tDCS association with antidepressants showed favorable results to this technology in a sample with depression and varied clinical characteristics. Regarding safety of this technology, tDCS did not show adverse effects of greater severity, but was verified to have an increased risk of TEM.

Emergent TIPS for acute gastroesophageal variceal bleeding in cirrhotic patients with hepatocellular carcinoma.

To estimate the safety and effectiveness of emergent transjugular intrahepatic portosystemic shunt (TIPS) creation for acute variceal bleeding (AVB) in cirrhotic patients with hepatocellular carcinoma (HCC). Data of thirty-three patients with AVB and HCC undergoing emergent TIPS creation from January 2016 to January 2022 were enrolled and were retrospectively analyzed. The primary outcomes were the safety of emergent TIPS creation, the bleeding control rate, and the rebleeding rate. The secondary outcomes included overall survival (OS), liver function, overt hepatic encephalopathy (HE), and shunt dysfunction. Emergent TIPS creation was technically successful in 33 patients (100%) and one (3.0%) patient suffered a major procedure-related adverse event. The control rate of bleeding (within 5days) was 100%. During a median follow-up period of 26.3months, rebleeding occurred in 6 (18.2%) patients. The median OS was 20.0months. The 6-week and 1-year survival rates were 87% and 65%, respectively. Laboratory tests showed no significant impairment of liver function following TIPS creation. The incidences of overt HE and shunt dysfunction were 24.2% and 6.1%, respectively. Emergent TIPS creation is feasible and effective for treatment of AVB in cirrhotic patients with HCC.

Magnetic Compression Anastomosis of Benign Short-Segment Ureteral Obstruction

PurposeTo investigate the feasibility, safety, and effectiveness of magnetic compression anastomosis of benign short-segment ureteral obstruction. Materials and MethodsPatients referred for failure of ureteral double-J stent placement because of impassable benign ureteral obstruction were included. Eleven patients (11 ureters) with a mean age of 57.5 years (range, 19–85 years; 8 women) underwent ureteral magnetic compression anastomosis. All patients had indwelling nephrostomy catheters. In all patients, anterograde and retrograde ureteral stent placements were unsuccessful using either interventional or cystoscopic access. Ureteral magnetic compression anastomosis was performed as a 2-step procedure. In the first step, magnets were placed. In the second step, the stricture was traversed via magnetic compression anastomosis. Successful establishment of anastomosis and ureteral double-J stent placement were considered technical success. The mean time for complete magnetic adherence and fluoroscopy time for each procedure were recorded. ResultsFive patients (45%) had an ileal conduit. The technical success rate was 91% (n = 10/11). The mean time for magnetic adherence was 5.7 days (SD ± 1.3). The mean single-rotation fluoroscopy times during the first and second steps of the procedure were 9.45 minutes (SD ± 2.09) and 15.70 minutes (SD ± 2.62), respectively. Magnets were removed with the support of either balloon catheters (n = 9) or biopsy forceps (n = 2). No procedure-related adverse events occurred. ConclusionsMagnetic compression anastomosis of benign ureteral obstruction is feasible and safe and can be performed in an interventional radiology (IR) suite without the need for endoscopy.

Intracardiac echocardiography-guided pulsed-field ablation for successful ablation of atrial fibrillation: a propensity-matched analysis from a large nationwide multicenter experience.

Intracardiac echocardiography (ICE) is increasingly employed in atrial fibrillation (AF) ablation procedures, with the potential to enhance procedural efficacy. Nevertheless, there is currently a lack of evidence assessing the impact of ICE on the efficiency, effectiveness, and safety outcomes in the context of novel pulsed-field ablation (PFA) for AF. We aimed to assess whether the use of ICE could improve procedural parameters in a large population undergoing AF ablation with FARAPULSE™ catheter. Consecutive patients who had undergone PFA of AF from nine Italian centers were included. In procedures where the ICE catheter was employed for guidance (ICE-guided group), it was used to maneuver the PFA catheter within the left atrium to achieve optimal contact with atrial structures. We analyzed 556 patients: 357 (66%) with paroxysmal AF, 499 (89.7%) de novo PVI. ICE-guided procedures (n = 138) were propensity matched with patients with a standard approach (n = 138), and their outcomes were compared. During ICE-guided procedures, no improvement in procedural metrics was recorded (ICE vs Standard, 23 ± 6min vs 18.5 ± 9min for time to PVI, p < 0.0001; 38.8 ± 7 vs 32.5 ± 5 number of PFA deliveries to achieve PVI, p < 0.0001; 68.8 ± 19min vs 71.8 ± 29min for primary operator time, p = 0.5301; 16.1 ± 8min vs 18.2 ± 10min for fluoroscopy time, p = 0.5476) except for support time (76.8 ± 26min vs 91.4 ± 37min, p = 0.0046). No major procedure-related adverse events were reported. Our findings confirmed that PFA could be consistently performed in a rapid, safe, and efficacious manner. The use of ICE to guide PFA was not associated with an improvement in procedural metrics.

Sodium zirconium cyclosilicate hydrate reduces medical expenses compared with hemodialysis in patients with acute hyperkalemia

BackgroundSodium zirconium cyclosilicate (SZC) has recently emerged as a therapeutic option for the management of acute hyperkalemia. Nevertheless, the relative effectiveness, safety, and financial considerations of SZC therapy versus conventional hemodialysis therapy remain uncertain.MethodsIn this retrospective study, we embarked upon a comparative analysis encompassing the financial aspects, safety profiles, and efficacy metrics associated with SZC therapy and hemodialysis in patients grappling with acute hyperkalemia. No patients had systemic congestion or uremia.ResultsA total of 21 patients (median 81 years old, 14 men) were included; 14 received SZC therapy and seven underwent hemodialysis. Acute hyperkalemia improved immediately within several days without any procedure-related adverse events, regardless of therapeutic interventions (p < 0.05 for both). Total medical expenses were significantly lower in the SZC group than in the hemodialysis group (55,596 [43,652, 69,761] vs. 419,768 [354,270, 514,700] Japanese yen, p < 0.001).ConclusionsIn the realm of acute hyperkalemia management, SZC therapy emerges as an economically judicious alternative, while upholding parity in terms of safety and effectiveness when compared with the conventional hemodialysis paradigm—unless complicated by systemic congestion or uremia. The pressing task at hand revolves around the discernment of the optimal patient demographic for SZC therapy within the ambit of acute hyperkalemia.

Treatment of severe symptomatic aortic valve stenosis using non-invasive ultrasound therapy: a cohort study

Calcific aortic stenosis is commonly treated using surgical or transcatheter aortic valve replacement; however, many patients are not considered suitable candidates for these interventions due to severe comorbidities and limited life expectancy. As such, non-invasive therapies might offer alternative therapeutic possibilities in these patients. This study aimed to assess the safety of non-invasive ultrasound therapy and its ability to improve valvular function by softening calcified valve tissue. This prospective, multicentre, single-arm series enrolled 40 adult patients with severe symptomatic aortic valve stenosis at three hospitals in France, the Netherlands, and Serbia between March 13, 2019, and May 8, 2022. Patients were treated with transthoracically delivered non-invasive ultrasound therapy. Follow-ups were scheduled at 1, 3, 6, 12, and 24 months. The primary endpoints were procedure-related deaths within 30 days and improved valve function. We report the 6-month data. This study is registered at ClinicalTrials.gov, NCT03779620 and NCT04665596. 40 high-risk patients with a mean Society of Thoracic Surgeons score of 5·6% (SD 4·4) and multiple severe comorbidities were included. The primary endpoint, procedure-related mortality, did not occur; furthermore, no life-threatening or cerebrovascular events were reported. Improved valve function was confirmed up to 6 months, reflected by a 10% increase in mean aortic valve area from 0·58 cm2 (SD 0·19) at baseline to 0·64 cm2 (0·21) at follow-up (p=0·0088), and a 7% decrease in mean pressure gradient from 41·9 mm Hg (20·1) to 38·8 mm Hg (17·8; p=0·024). At 6 months, the New York Heart Association score had improved or stabilised in 24 (96%) of 25 patients, and the mean Kansas City Cardiomyopathy Questionnaire score had improved by 33%, from 48·5 (SD 22·6) to 64·5 (21·0). One serious procedure-related adverse event occurred in a patient who presented with a transient decrease in peripheral oxygen saturation. Non-serious adverse events included pain, discomfort during treatment, and transient arrhythmias. This novel, non-invasive ultrasound therapy for calcified aortic stenosis proved to be safe and feasible. Cardiawave.

The Impact of Traction Methods on Endoscopic Submucosal Dissection Efficacy for Gastric Neoplasia: A Systematic Review and Meta-analysis.

Endoscopic submucosal dissection (ESD) for gastric neoplasms can be challenging due to limited traction and visualization. The efficacy of traction-assisted endoscopic submucosal dissection (TA-ESD) continues to require additional validation. This study aims to explore the safety and efficiency of TA-ESD for early gastric neoplasms located at varying sites, in comparison with conventional endoscopic submucosal dissection (C-ESD). We conducted a comprehensive literature search using databases up until August 2022. The outcome measures procedure time, en bloc resection rate, complete resection rate, procedure time, and procedure-related adverse event rate. We calculated pooled mean differences (MDs) and odds ratios (ORs) for these outcomes. The mean procedure time was significantly shorter in the TA-ESD group compared to the C-ESD group (MD - 14.9, 95% CI - 21.78 to - 8.03, I2 = 83%, p < 0.0001). Subgroup analysis revealed that mean procedure times for lesions on the greater curvature and upper/middle of the stomach were significantly shorter in the TA-ESD group - 19.2min (95% CI - 27.75 to - 10.65, I2 = 12%, p < 0.0001) and - 7.35min (95% CI - 35.4 to - 1.15, p = 0.04), respectively. The en bloc resection and complete resection rates were comparable between the two groups. The rate of perforation was significantly lower in the TA-ESD group than in the C-ESD group (OR 0.36, 95% CI 0.15-0.85, p = 0.02, I2 = 0%). This study demonstrates the potential benefits of TA-ESD over C-ESD in treating patients with early-stage gastric tumors, highlighting its safety and efficacy. The findings indicate a significant reduction in procedure times at challenging stomach sites with TA-ESD in comparison to C-ESD.

INNV-42. INTRA-ARTERIAL MELPHALAN FOR HISTIOCYTIC NEOPLASMS INVOLVING NEUROLOGIC, OCULAR, AND HEAD AND NECK STRUCTURES

Abstract BACKGROUND Histiocytic neoplasms are clonal hematopoietic disorders of myeloid lineage. Involvement of neurologic structures by histiocytic infiltration or disease-associated neurodegeneration (ND) represents a severe disease phenotype associated with morbidity and mortality. Despite recent advances with BRAF and MEK inhibitors, patients with neurohistiocytic involvement continue to demonstrate suboptimal outcomes. Intra-arterial chemotherapy (IAC) may represent an effective therapy for this disease manifestation. METHODS Patients with biopsy-proven histiocytic neoplasms involving neurologic, ocular, or head and neck structures were treated with intra-arterial melphalan delivered via selective catheterization of tumor arterial vasculature. Patients treated had refractory/persistent tumorous disease or progressive functional decline despite BRAF/MEK inhibition, or had limited disease appropriate for local therapy. Patients were evaluated for radiologic (PET or CT/MRI) response and functional neurologic response with quantified ataxia and dysarthria scales, or change in visual acuity (VA), as appropriate. Procedure-related adverse events as well as clinical and laboratory toxicities were captured. RESULTS 74 IAC treatments were administered to 17 patients, 12 with tumorous disease (6 Rosai-Dorfman disease; 3 xanthogranuloma; 3 Langerhans cell histiocytosis[LCH]; 1 Erdheim-Chester disease [ECD]), 5 with ND-LCH/ECD, and ten with disease-related impairment of VA. Patients received a range of 2-12 IAC doses. 9/12 (75%) patients with tumorous disease had complete or partial radiologic response. 4/5 patients with ND had measurable improvement in dysarthria and 2/5 had measurable improvement in ataxia. 4/10 patients had improved VA. Of all patients with clinical or radiologic response, three have experienced disease recurrence since IAC in long-term follow-up. No procedural adverse events were observed, 1 patient had neutropenia and 1 patient melphalan hypersensitivity. CONCLUSIONS IA melphalan is a safe and robustly effective treatment option for tumorous and ND histiocytic neoplasms of neurologic, ocular, and head and neck structures.

Prospective, multicenter clinical trial comparing the M6-C compressible cervical disc with anterior cervical discectomy and fusion for the treatment of single-level degenerative cervical radiculopathy: 5-year results of an FDA investigational device exemption study

BACKGROUND CONTEXTVarious total disc replacement (TDR) designs have been compared to anterior cervical discectomy and fusion (ACDF) with favorable short and long-term outcomes in FDA-approved investigational device exemption (IDE) trials. The unique design of M6-C, with a compressible viscoelastic nuclear core and an annular structure, has previously demonstrated favorable clinical outcomes through 24 months. PURPOSETo evaluate the long-term safety and effectiveness of the M6-C compressible artificial cervical disc and compare to ACDF at 5 years. STUDY DESIGNProspective, multicenter, concurrently and historically controlled, FDA-approved IDE clinical trial. PATIENT SAMPLESubjects with one-level symptomatic degenerative cervical radiculopathy were enrolled and received M6-C (n=160) or ACDF (n=189) treatment as part of the IDE study. Safety outcomes were evaluated at 5 years for all subjects. The primary effectiveness endpoint was available at 5 years for 113 M6-C subjects and 106 ACDF controls. OUTCOME MEASURESThe primary endpoint of this analysis was composite clinical success (CCS) at 60 months. Secondary endpoints were function and pain (neck disability index, VAS), physical quality of life (SF-36, SF-12), safety, neurologic, and radiographic assessments. METHODSPropensity score subclassification was used to control for selection bias and match baseline covariates of the control group to the M6-C subjects. Sixty-month CCS rates were estimated for each treatment group using a generalized linear model controlling for propensity score. RESULTSAt 5 years postoperatively, the M6-C treatment resulted in 82.3% CCS while the ACDF group showed 67.0% CCS (superiority p=.013). Secondary endpoints indicated that significantly more M6-C subjects achieved VAS neck and arm pain improvements and showed maintained or improved physical functioning on quality-of-life measures compared to baseline assessments. The M6-C group-maintained flexion-extension motion, with significantly greater increases from baseline disc height and disc angle than observed in the control group. The rates of M6-C subsequent surgical interventions (SSI; 3.1%) and definitely device- or procedure-related serious adverse events (SAE failure; 3.1%) were similar to ACDF rates (SSI=5.3%, SAE failure=4.8%; p>.05 for both). CONCLUSIONSSubjects treated with the M6-C artificial disc demonstrated superior 5-year achievement of clinical success when compared to ACDF controls. In addition, significantly more subjects in the M6-C group showed improved pain and physical functioning scores than observed in ACDF subjects, with no difference in reoperation rates or safety outcomes.

Patent foramen ovale closure reduces migraine burden: a meta-analysis

Abstract Background Patent foramen ovale (PFO) closure has been shown to reduce the risk of recurrent stroke in selected patients. On the other hand, the efficacy of PFO closure in reducing migraine attacks remains a matter of debate. Purpose We performed a systematic review and meta-analysis of randomized controlled trials that compared PFO closure plus medical therapy to medical therapy alone for the management of migraine. Methods A comprehensive search was conducted in PubMed through December 10, 2022. The main efficacy endpoints were the complete cessation of migraine, the mean reduction in monthly migraine days and the mean reduction in monthly migraine attacks. The main safety outcome was the occurrence of major procedure related adverse events. Results Our search retrieved 667 results. Three randomized controlled trials including 448 patients were included in the final analysis. Of these, 231 patients (mean age 43.4±10.5 years) underwent PFO closure, while 217 (43.7±10.6) were treated conservatively with medical therapy. In the medical treatment group, 190 patients underwent a sham procedure. The follow-up period ranged from 6 to 12 months. Overall, no significant association between PFO closure and complete migraine cessation was observed [Hazard Ration 3.31, 95% confidence intervals (CI): 0.72 – 15.17 – Figure 1). On the other hand, PFO closure was associated with a significant reduction in the mean number of migraine days per month [mean difference (MD): 1.23, 95% CI: 0.44-2.10, p=0.024, Figure 2A] as well as with a significant decrease in monthly migraine attacks (MD: 0.58, 95%CI : 0.25-0.91, p=0.017, Figure 2B). In respect of efficacy endpoint, a total of 9 transient, procedure related adverse events, including access-site bleeding, hematoma and tachycardia were reported in the implantation group. Conclusions PFO closure plus medical treatment compared to medical treatment alone was related with fewer and shorter migraine attacks. These results suggest clinical benefit of PFO closure in selected patients with migraine.Figure 1.Figure 2.

Pulmonary vein isolation versus PVI + adjunctive strategy (substrate modification and renal denervation therapy) for the reduction of 12-month AF recurrence

Abstract Background of the Study This meta-analysis assessed the latest evidence on the use of adjunct ablation strategies to standard pulmonary vein isolation (PVI) for treating atrial fibrillation (AF). Adjunct treatments were further classified as substrate modification (posterior wall isolation, linear ablation and ablation of complex fractionated atrial electrograms) or renal denervation (RDN). Purpose While ablation maintains sinus rhythm more effectively than antiarrhythmic drug therapy, recurrent AF remains common after 12 months, occurring in up to 40-60% of patients undergoing standard PVI ablation. Treatment strategies have diversified in a response to these challenges. These include reduction of the arrhythmogenic substrate, modulation of autonomic inputs and improvement of risk factors, such as hypertension. Methods A systematic literature search from MEDLINE and PubMed electronic databases was performed until November 2022. The primary outcome was 12-month AF recurrence defined as AF lasting ≥30 seconds on follow-up. The secondary outcome was incidence of procedure-related major adverse events (MAEs), defined as death, clinical strokes, acute heart failure decompensation, pericardial effusion causing tamponade, arteriovenous fistulas, and atrioesophageal fistulas. Results Nine studies comprising 1686 patients were included in the final analysis. AF recurrence was 487/1082 (45%) in the PVI + Adjunct group and 204/604 (33.8%) in PVI Alone. Pooled analysis showed that PVI + adjunct was inconclusively associated with less incidence of 12-month AF recurrence (RR 0.79, 95% CI 0.60–1.04, I2 = 70%, p-value 0.09). Subgroup analyses of six RCTs under the PVI with substrate modification arm showed non-significant increase in 12-month AF recurrence in PVI + substrate modification (RR 0.85, 95% CI 0.6-1.21, p-value 0.38). Subgroup analyses of the 3 RCTs on hypertensive AF patients showed strong evidence of decreased 12-month AF recurrence in PVI + RDN compared to PVI alone (RR 0.65, 95% CI 0.48-0.89, p-value 0.007). Secondary outcome of major adverse procedure-related events in overall pooled analysis showed 8 events in 604 patients undergoing PVI alone, and 23 events in 1082 patients undergoing PVI + adjunct ablation. There is no significant difference in the number of reported MAE in PVI alone over PVI + adjunct (RR 1.16 [0.49-2.75], p = 0.73). Conclusion Overall, PVI with adjunctive strategies did not significantly reduce 12-month AF recurrence after ablation. Among these strategies, RDN demonstrated a significant reduction in the primary endpoint, whereas substrate modification did not. There was no significant difference in MAEs reported between standard therapy versus those with adjunctive treatment. We conclude that PVI ablation strategies should be individualized, and modification of both triggers and risk factors for AF show better rhythm control on follow-up.

Mechanical thrombectomy in intermediate- and high-risk acute pulmonary embolism: haemodynamic outcome at 3 months

Abstract Background Haemodynamic data months after mechanical thrombectomy for pulmonary embolism (PE) are scarce. Aims To assess the haemodynamic effects of mechanical thrombectomy in acute PE with right heart overload. Methods In this prospective, open-label study, patients with acute symptomatic, computed tomography-documented PE with signs of right heart overload underwent mechanical thrombectomy using the FlowTriever System. Right heart catheterization was performed immediately before and after thrombectomy and after three months. Transthoracic echocardiography was performed before thrombectomy, discharge, and at three months. This analysis was done after the first 20 patients completed their three months of follow-up. Results Twenty-nine patients (34% female) underwent mechanical thrombectomy, of which 20 completed three months follow-up with right heart catheterization. Most patients (17%) were at high or intermediate-high (76%) risk and had bilateral pulmonary embolisms (79%). Before thrombectomy, systolic pulmonary arterial pressure (sPAP) was severely elevated (mean 51.3±11.6 mmHg). Mean sPAP dropped by -15.0 mmHg (95% confidence interval [CI]: -18.9 to -11.0; p&amp;lt;0.001) immediately following the procedure and continued to decrease from post-thrombectomy to three months (-6.4 mmHg, 95% CI: -10-0 to -2.9; p=0.002) (Figure). Right ventricle (RV)/left ventricle (LV) ratio immediately reduced within two days by -0.37 (95% CI: -0.47 to -0.27; p&amp;lt;0.001). The proportion of patients with a TAPSE/sPAP ratio &amp;lt;0.31 mm/mmHg decreased from 28% at baseline to 0% before discharge and at three months (p=0.007). There were no procedure-related major adverse events. Conclusions Mechanical thrombectomy for acute PE was safe and immediately reduced PAP and improved right heart function. The reduction in PAP was maintained at three months follow-up.Systolic pulmonary artery pressure

Biomarkers of myocardial injury during cellular electroporation by means of pulsed-field ablation and radiofrequency of atrial fibrillation

Abstract Background Several authors implemented different biomarkers to evaluate and quantify the size of effective atrial fibrillation (AF) ablation lesions after pulmonary veins isolation (PVI) with thermal energy source. However, limited data have been reported on the effects of a new form of non-thermal energy such as electroporation obtained by means of a pulsed-field ablation (PFA, Farapulse) system. Purpose Our analysis aims to compare acute myocardial injury through different biomarkers variation after PVI performed with different technologies (PFA vs radiofrequency, RF). Methods All consecutive patients (pts) undergoing AF ablation with PFA at our center were included. A PFA protocol-directed PVI was applied using 2kV with 8 applications per vein. RF deliveries were deployed according to a wide antral lesion set around the PVs at 50W. Pre- and post-procedure samples of cardiac troponin I (hs-TnI, ng/l), creatinine kinase-MB (CK-MB, ng/dl), fibrinogen (FB, mg/dl), myoglobin (Myo, ng/ml), N-terminal (NT)-pro hormone B-type natriuretic peptide (NT-ProBNP, pg/ml) and C-reactive protein (CRP, mg/dl) values were collected before PVI and at 24h after ablation. Ablation endpoint was PVI. Results Fourty-nine pts were included (62±12 years, 63% male, 84% with paroxysmal AF). PFA cases were 35 (71.4%) whereas RF cases were 14 (28.6%). Evaluating the kinetic of each cardiac biomarker, no differences were found between baseline and 24h for both FB (363±93 at baseline vs 387±112 at 24h, p=0.4513) and NT-ProBNP (137[61-462] at baseline vs 227[157-423] at 24h, p=0.0544). On the contrary kinetics of remaining biomarkers differed and significantly increased from baseline to 24h: 61±22 to 112±101 for Myo level, p=0.0017; 0.38±0.2 to 1.45±2.2 for CRP values, p&amp;lt;0.0001; 1.5±0.7 to 19.4±14 for CK-MB level, p&amp;lt;0.0001 and 11.2±20 to 6177±5765 for hs-TnI level, p&amp;lt;0.0001. By looking at the effect of the ablation strategy on cardiac biomarkers, hs-TnI level, CRP level and CK-MB were significantly different between groups at 24h after PFA/RF (hs-TnI: 7556±6025 for PFA vs 2038±1257 for RF, p&amp;lt;0.0001; CRP: 1.6±2.3 for PFA vs 0.9±1.2 for RF, p=0.0297; CK-MB: 23.7±12 for PFA vs 6.3±9.6 for RF, p&amp;lt;0.0001). PVI was achieved in all patients (100%) using only RF or PFA. No major procedure-related adverse events were reported. Conclusion Our preliminary results showed that cardiac troponin I enzyme level, C-reactive protein and creatinine kinase-MB increased after PVI by means of both radiofrequency and pulsed-field ablation and were higher after cellular electroporation by PFA than RF.

Redo transcatheter edge-to-edge mitral valve repair: a single centre experience

Abstract Introduction: Mitral valve transcatheter edge-to-edge repair (TEER) has been established as a therapy for patients with severe symptomatic mitral regurgitation (MR) who are at high surgical risk. Failure to implant a TEER device and the occurrence of residual or recurrent MR ≥3+ are well documented but data regarding outcomes of redo-TEER following initial failure are sparse. Purpose To evaluate the safety and efficacy of redo-TEER following initial failed intervention. Methods We included 16 patients who underwent redo-TEER for symptomatic MR ≥3+ from July 2016 to December 2022. Acute results were assessed by echocardiography prior to discharge and safety was evaluated clinically, according to the occurrence of procedure-related adverse events. Mid- and long-term outcomes were evaluated at three months and one year respectively. Data were obtained retrospectively by chart review. Mortality data were drawn from the national death registry. Results Reasons for redo-TEER include device failure without detachment in nine (56%) patients, device failure due to single leaflet detachment in four (25%) patients and initial implantation failure in three (19%) patients. Median time from index procedure was 167 days (range: 19 – 1457 days). Technical (implantation of a TEER device) and procedural (MR ≤2+ at discharged) success were achieved in 94% and 87.5% of patients undergoing repeat intervention respectively. MR grade was reduced to 1+ in 71% of patients who had successful TEER. No intra-procedural mortality or life-threatening complications were noted. Mean post-TEER hospitalization length was 1.8 ± 1.3 days. No deaths were noted during the first year following redo-TEER. Echocardiography at three months and one year demonstrated MR ≤2+ for all patients in whom TEER was successful. At three months and one-year follow-up, respectively 67% and 50% of patients who underwent successful intervention were in New York Heart Association (NYHA) class I or II and only one had been hospitalized for heart failure. Conclusion Repeat mitral TEER following initial procedural failure is safe and has high acute and mid-term success rates. More research is needed to better characterise patients likely to benefit from repeated intervention.

Abstract 13750: Concomitant Transcatheter Debulking of Right Heart Vegetations During Extraction of Transvenous Device System for Endocarditis: An Eight Case Series

Background: Right heart (RH) infective endocarditis (IE) is a rare but serious complication of transvenous devices (TVD) often requiring system extraction. Surgery is often necessary for large vegetations or when bacteremia persists despite antibiotics. Objective: To evaluate outcomes of patients who underwent transcatheter debulking of IE-related RH vegetations in the setting of a transvenous device endocarditis. Methods: Patients with TVD and IE with RH vegetations were included in this analysis. Half of the patients were debulked using a thrombus aspiration system, while in the other half a hydrodynamic thrombectomy system was used. This was completed via a femoral approach with intracardiac echocardiography guidance. Intra and post-procedural outcomes were recorded. Results: Eight patients with a median age of 58 years, 62.5% male, with TVD, IE, and RH vegetations were included. Vegetations were located on the TV (2), RA lead (4), RV lead (2) and the floor of the RA along the cavotricuspid isthmus (1). The largest vegetation in this series was 5 cm by 2 cm with a volume of 62.83 cm3 and the smallest was 0.4 cm by 0.3 cm with a volume of 0.15 cm3. All patients had substantial vegetation burden causing clinically significant valve dysfunction. The vegetations were successfully debulked in all eight cases. Post-procedure imaging in all eight patients showed at least a 80% reduction in vegetation burden. All patients with TVP leads underwent successful extraction of the pacing systems. All patients tolerated their procedures well and remained free of infection at follow-up after completing a 6-week course of intravenous antibiotics. There were no procedure-related adverse events recorded within 30 days of intervention. Conclusion: TCD is a potential alternative in patients with device infection and large vegetations who are not candidates for surgical intervention. Long-term implications of this intervention in this high-risk population needs further studies.

Cell-based versus corticosteroid injections for knee pain in osteoarthritis: a randomized phase 3 trial

Various types of cellular injection have become a popular and costly treatment option for patients with knee osteoarthritis despite a paucity of literature establishing relative efficacy to each other or corticosteroid injections. Here we aimed to identify the safety and efficacy of cell injections from autologous bone marrow aspirate concentrate, autologous adipose stromal vascular fraction and allogeneic human umbilical cord tissue-derived mesenchymal stromal cells, in comparison to corticosteroid injection (CSI). The study was a phase 2/3, four-arm parallel, multicenter, single-blind, randomized, controlled clinical trial with 480 patients with a diagnosis of knee osteoarthritis (Kellgren–Lawrence II–IV). Participants were randomized to the three different arms with a 3:1 distribution. Arm 1: autologous bone marrow aspirate concentrate (n = 120), CSI (n = 40); arm 2: umbilical cord tissue-derived mesenchymal stromal cells (n = 120), CSI (n = 40); arm 3: stromal vascular fraction (n = 120), CSI (n = 40). The co-primary endpoints were the visual analog scale pain score and Knee injury and Osteoarthritis Outcome Score pain score at 12 months versus baseline. Analyses of our primary endpoints, with 440 patients, revealed that at 1 year post injection, none of the three orthobiologic injections was superior to another, or to the CSI control. In addition, none of the four groups showed a significant change in magnetic resonance imaging osteoarthritis score compared to baseline. No procedure-related serious adverse events were reported during the study period. In summary, this study shows that at 1 year post injection, there was no superior orthobiologic as compared to CSI for knee osteoarthritis. ClinicalTrials.gov Identifier: NCT03818737

Jejunal levodopa infüzyonu alan Parkinson hastalarında PEG-J tüpünün kısa ve uzun dönem güvenilirliği ve devamlılığı

Aims: To investigate PEG-J related adverse events and tube durability in patients with Parkinson’s disease who underwent PEG-J procedure for jejunal drug infusion. &#x0D; Methods: PEG-J implanted patients, who were planned jejunal levodopa infusion, were included in the study. The demographic characteristics of the patients, tube durability, tube replacement, reason for tube replacement, number of procedures, and adverse events related to procedures were retrospectively analyzed. &#x0D; Results: Thirty-four patients with a mean age of 65.7±9.8 years included in the study. The mean total PEG-J follow-up period of the patients was 33.6±21.1 months. Functions of PEG-J tubes were preserved in 82.5% at 6 months, 78.4% at 12 months, and 65.2% at 18 months. Twenty-one (% 61,8) patients required at least one PEG-J replacement. Of the PEG-J replacements, 90.4% were due to device-related advers events. A total of 29 procedure or stoma related adverse events occurred in 21 (61.8%) patients, and a total of 28 PEG-J tube related adverse events occurred in 19 (55.9%) patients. A total of 6 (17.5%) early procedure-related adverse events (acute abdomen and peritonitis, prolonged bleeding, stoma leakage, stoma infection) were observed, all occurring in the first 7 days. Twenty-three (67.6%) stoma-related late adverse events (stoma leakage, stoma infection, abscess) were detected. Two patients who developed peritonitis were successfully treated with conservative treatments.&#x0D; Conclusion: PEG-J used for drug application is a safe method and can be used for a long time without the need for frequent replacement. Most of advers events can be managed with conservative treatments.

Safety and efficacy of the Amplatzer™ Trevisio™ intravascular delivery system: Post-approval study results

BackgroundThe Amplatzer™ Trevisio™ Intravascular Delivery System (Trevisio DS; Abbott Laboratories, Chicago, IL, USA) facilitates the delivery of Amplatzer™ Occluders and features an ultraflexible tip, which improves assessment of occluder position before release. AimsTo assess the safety and efficacy of the Trevisio DS for transcatheter closure of patent foramen ovale and atrial septal defect. MethodsThe Amplatzer™ Trevisio™ Intravascular Delivery System Post-Approval Study was a prospective, postmarket, single-arm, multicentre, observational study of the Trevisio DS. Enrolled patients were indicated for transcatheter closure of patent foramen ovale or atrial septal defect. In all procedures, the Trevisio DS was used to deliver Amplatzer™ Occluders. Technical success was defined as successful deployment and release of at least one occluder. Device- or procedure-related serious adverse events were tracked until discharge or day 7, whichever occurred earlier. ResultsThe study enrolled 144 patients with patent foramen ovale and 107 patients with atrial septal defect at 22 European sites; 53 patients with atrial septal defect (49.6%) were aged<18years. The rate of technical success was 98.4% (97.2% for atrial septal defect, 99.3% for patent foramen ovale). There was one serious adverse event (0.4%), an acute periprocedural device embolization that occurred after occluder release in a patient with atrial septal defect; the device was retrieved percutaneously. This was determined by the implanter to be unrelated to the performance of the Trevisio DS. ConclusionsThe Trevisio DS exhibited a high rate of technical success and an excellent safety profile during transcatheter closure of patent foramen ovale and atrial septal defect.