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BACKGROUND: Pulsed field ablation (PFA) has become increasingly important in the treatment of cardiac arrhythmias. In addition to single-shot devices mainly used for pulmonary vein isolation, focal PFA may provide a treatment option that increases the versatility of the technique. OBJECTIVE: The purpose of this study was to provide data on feasibility, safety, and long-term outcome of focal PFA for ablation of complex atrial tachycardia (AT). METHODS: All consecutive patients (n = 34) with complex AT treated at our department between 2022 and 2023 with a focal PFA system (CENTAURI™, Galvanize Therapeutics) were included. The majority of patients (32/34) previously had undergone at least 1 radiofrequency ablation. Established contact force-sensing catheters were used for PFA application in combination with a PFA generator. Pulsed electric field trains were conducted in a R-wave triggered manner. RESULTS: Acute procedural success was accomplished in all patients. PFA included creation of 51 linear lesions and (re)isolation of 12 pulmonary veins. Mean procedural duration was 102.7 ± 30.3 minutes, with left atrial dwell time of 75.0 ± 24.7 minutes. Mean fluoroscopy duration was 8.7 ± 5.3 minutes. No complications occurred. After mean follow-up of 340.9 ± 130.1 days, recurrence of any AT occurred in 15 patients (44.1%). During 9 reablations, 3 gaps in previously created linear lesions were detected; the majority of recurrences (n = 6) were not related to previous PFA lesion creation. CONCLUSION: Focal PFA of complex AT substrates was safe and efficient. Acute procedural success was 100%. After 1 year, the majority of patients were in sinus rhythm. A minority of recurrences was caused by insufficient PFA lesion creation.
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BACKGROUND: Lesion durability and transmurality are crucial for successful radiofrequency (RF) ablation. This study provides a model of real-time RF lesion visualization and insights into the role of underlying parameters, as local impedance (LI). METHODS: A force-sensing, LI-sensing catheter was used for lesion creation in an ex vivo model involving cross-sections of porcine cardiac preparations. During 60 s of RF application, one measurement per second was performed regarding lesion size and available ablation parameters. In total, 1847 measurements from n = 36 lesions were performed. Power (20-50 W) and contact force (1-5 g, 10-15 g, 20-25 g) were systematically alternated. RESULTS: Lesion formation was most prominent in the first seconds of RF application during which nonlinear lesion growth was observed (max. 1.08 mm/s for lesion depth and 2.71 mm/s for lesion diameter). Power levels determined the extent of lesion formation in the early phase. After 20 s, lesion size growth velocity approaches 0.1 mm/s at all power levels. LI changes were also highest in the first seconds (up to - 12 Ω/s) and decreased to less than - 0.1Ω/s after prolonged application. CONCLUSION: Lesion formation in irrigated RF ablation is a nonlinear process. Final lesion size resulting from an RF application is mainly influenced by high rates of lesion growth in the first seconds of ablation. LI seems to be a good surrogate for differentiating changes in lesion formation.
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Ablación por Catéter , Porcinos , Animales , Ablación por Catéter/métodos , Sistemas de Computación , Impedancia Eléctrica , Técnicas In Vitro , Ablación por Radiofrecuencia/métodos , Cirugía Asistida por Computador/métodosRESUMEN
BACKGROUND: Pulse field ablation (PFA) is a novel catheter ablation technology with potential safety benefits due to its tissue selectivity. It has the potential to directly damage or interact with the functionality of cardiac implantable electronic devices (CIEDs) in the form of electromagnetic interference (EMI). The aim of our study was to assess the impact of PFA on CIEDs. METHODS: PFA lesions (45 per CIED) were applied from the Farapulse system to CIEDs (< 5 cm from the lead tip and < 15 cm from the generator). All devices were checked before and after PFA application for proper sensing and pacing functionality as well as for integrity of shock circuits in ICDs using a heart simulator. Moreover, devices were then interrogated for any spontaneous reprogramming, mode switching or other EMI effects. RESULTS: In total, 44 CIEDs were tested (16 pacemaker, 21 ICDs, 7 CRT-P/D) with 1980 PFA applications. There was no change in device settings, functionality and electrical parameters, and there was no macroscopic damage to the devices. The risk of damage to the electric components or leads on a patient-based analysis is 0/44 (95% CI 0-8%) and on a PFA pulse-based analysis is 0/1980 (95% CI 0-0.2%). Clinically relevant EMI appeared with oversensing and pacing inhibition but not tachycardia detection. CONCLUSIONS: Bipolar PFA appears safe and does not result in damage to CIEDs or leads. Clinically relevant EMI does occur, but appropriate peri-procedural programming may mitigate this. In vivo studies are needed to confirm our findings.
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INTRODUCTION: Despite advanced ablation strategies and major technological improvements, treatment of persistent atrial fibrillation (AF) remains challenging and the underlying pathophysiology is not fully understood. This study analyzed the multiple procedure outcome and safety of catheter ablation of spatiotemporal dispersions (DISPERS) detected by artificial intelligence (AI)-guided software in patients with long-standing persistent AF. METHODS AND RESULTS: The Volta VX1 software was used for 50 consecutive patients undergoing catheter ablation for persistent AF. First, high-density mapping (78% biatrial) with a multipolar mapping catheter was performed. In addition to pulmonary vein isolation (PVI), ablation of DISPERS was performed aiming at homogenizing, dissecting, isolating, or connecting DISPERS areas to nonconducting anatomical structures. Follow-up contained regular visits at our outpatient clinic at 1, 3, 6, and 12 months including 7-day Holter electrocardiograms. Patients were mainly suffering from long-standing persistent AF (mean AF duration 50.30 ± 54.28 months). Following PVI, ablation of left atrial and right atrial DISPERS areas led to AF cycle length prolongation (mean of 162.0 ± 16.6 to 202.2 ± 21.6 ms after) and AF termination to atrial tachycardia (AT) or sinus rhythm (SR) in 12 patients (24%). No stroke or pericardial effusion occurred; major groin complications (pseudoaneurysm n = 1, atrioventricular fistula n = 1) were detected in two patients. After a blanking period of 6 weeks, recurrence of any atrial arrhythmia was documented in 26 patients (52%). The majority of patients presented with organized AT (n = 15) while AF was present in n = 9 patients and AT/AF was observed in n = 2 patients. Twenty-two patients underwent reablation. During a mean follow-up of 363.14 ± 187.42 days and after an average of 1.46 ± 0.68 procedures, 82% of patients remained in stable SR. CONCLUSION: DISPERS-guided ablation using machine learning software (the Volta VX1 software) in addition to PVI in long-standing persistent AF ablation resulted in high long-term success rates regarding AF and AT elimination. Most arrhythmia recurrences were reentrant AT. After a total of 1.46 ± 0.68 procedures, freedom from AF/AT was 82%. Despite prolonged procedure times complication rates were low. Randomized studies are necessary to evaluate long-term efficacy of dispersion-guided ablation using AI.
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Fibrilación Atrial , Ablación por Catéter , Venas Pulmonares , Taquicardia Supraventricular , Humanos , Fibrilación Atrial/diagnóstico , Fibrilación Atrial/cirugía , Inteligencia Artificial , Resultado del Tratamiento , Ablación por Catéter/efectos adversos , Ablación por Catéter/métodos , Venas Pulmonares/cirugía , RecurrenciaRESUMEN
BACKGROUND: Data regarding uninterrupted oral anticoagulation in patients with chronic kidney disease (CKD) during catheter ablation for left atrial arrhythmias is limited. This study aimed to evaluate the safety and efficacy of periprocedural uninterrupted direct oral anticoagulants (DOAC) compared with uninterrupted phenprocoumon in patients with CKD undergoing left atrial catheter ablation. METHODS AND RESULTS: We conducted a retrospective single-center study of patients who underwent left atrial catheter ablation between 2016 and 2019 with underlying chronic kidney disease (glomerular filtration rate (GFR) between 15 and 45 ml/min). The primary objective of this study was to investigate whether direct oral anticoagulant (DOAC) therapy or warfarin presents a superior safety profile in patients with chronic kidney disease (CKD) undergoing left atrial catheter ablation. We compared periprocedural complications (arteriovenous fistula, aneurysm, significant hematoma (> 5 cm)) and/or bleeding (drop in hemoglobin of >2 g/dl, pericardial effusion, retroperitoneal bleeding, other bleeding, stroke) between patients receiving either uninterrupted DOAC or warfarin therapy. Secondary analysis included patient baseline characteristics as well as procedural data. A total of 188 patients (female n = 108 (57%), mean age 75.3 ± 8.1 years, mean GFR 36.8 ± 6 ml/min) were included in this study. Underlying arrhythmias were atrial fibrillation (n = 104, 55.3%) and atypical atrial flutter (n = 84, 44.7%). Of these, n = 132 patients (70%) were under a DOAC medication, and n = 56 (30%) were under phenprocoumon. Major groin complications including pseudoaneurysm and/or AV fistula occurred in 8.9% of patients in the phenprocoumon group vs. 11.3% of patients in the DOAC group, which was not statistically significant (p = 0.62). Incidence of cardiac tamponade (2.3% vs. 0%; p = 0.55) and stroke (0% vs. 0%) were low in both DOAC and phenprocoumon groups with similar post-procedural drops in hemoglobin levels (1.1±1 g/dl vs 1.1±0.9 g/dl; p = 0.71). CONCLUSION: The type of anticoagulation had no significant influence on bleeding or thromboembolic events as well as groin complications in this retrospective study. Despite observing an increased rate of groin complications, the uninterrupted use of DOAC or phenprocoumon during left atrial catheter ablation in patients with CKD appears to be feasible and effective.
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INTRODUCTION: Pulmonary vein isolation (PVI) using radiofrequency ablation (RFA) is an established treatment strategy for atrial fibrillation (AF). To improve PVI efficacy and safety, high-power short-duration (HPSD) ablation and pulsed-field ablation (PFA) were recently introduced into clinical practice. This study aimed to determine the extent of myocardial injury and systemic inflammation following PFA, HPSD, and standard RFA using established biomarkers. METHODS: We included 179 patients with paroxysmal AF receiving first-time PVI with different ablation technologies: standard RFA (30-40 W/20-30 s, n = 52), power-controlled HPSD (70 W/5-7 s, n = 60), temperature-controlled HPSD (90 W/4 s, n = 32), and PFA (biphasic, bipolar waveform, n = 35). High-sensitivity cardiac troponin T (hs-cTnT), creatine kinase (CK), CK MB isoform (CK-MB), and white blood cell (WBC) count were determined before and after ablation. RESULTS: Baseline characteristics were well-balanced between groups (age 63.1 ± 10.3 years, 61.5% male). Postablation hs-cTnT release was significantly higher with PFA (1469.3 ± 495.0 ng/L), HPSD-70W (1322.3 ± 510.6 ng/L), and HPSD-90W (1441.2 ± 409.9 ng/L) than with standard RFA (1045.9 ± 369.7 ng/L; p < .001). CK and CK-MB release was increased with PFA by 3.4-fold and 5.8-fold, respectively, as compared to standard RFA (p < .001). PFA was associated with the lowest elevation in WBC (Δ1.5 ± 1.5 × 109 /L), as compared to standard RFA (Δ3.8 ± 2.5 × 109 /L, p < .001), HPSD-70W (Δ2.7 ± 1.7 × 109 /L, p = .037), and HPSD-90W (Δ3.6 ± 2.5 × 109 /L, p < .001). CONCLUSION: Among the four investigated ablation technologies, PFA was associated with the highest myocardial injury and the lowest inflammatory reaction.
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Fibrilación Atrial , Ablación por Catéter , Lesiones Cardíacas , Venas Pulmonares , Humanos , Masculino , Persona de Mediana Edad , Anciano , Femenino , Fibrilación Atrial/diagnóstico , Fibrilación Atrial/cirugía , Forma MB de la Creatina-Quinasa , Inflamación/diagnóstico , Venas Pulmonares/cirugía , Troponina T , Ablación por Catéter/efectos adversos , Resultado del Tratamiento , RecurrenciaRESUMEN
BACKGROUND: The aim of this study was to assess long-term efficacy and safety of empirical slow pathway (ESP) ablation in pediatric and adult patients with a special interest in patients without dual AV nodal physiology (DAVNP). METHODS: A retrospective single-center review of patients who underwent ESP ablation between December 2014 and September 2022 was performed. Follow-up included telephone communication, letter questionnaire and outpatient presentation. Recurrence was based on typical symptoms. RESULTS: 115 patients aged 6-81 years (median age 36.3 years, 59.1% female; 26 pts < 18 years) were included. A typical history was present in all patients (100%), an ECG documentation of narrow complex tachycardia in 97 patients (84%). Patients were divided into three groups: Group 1 without DAVNP (n = 23), Group 2 with AH jump (n = 30) and Group 3 with AH jump and at least one AV nodal echo beat (n = 62). No permanent AV block was observed. During a median follow-up of 23.6 ± 22.7 months, symptom recurrence occurred in 7/115 patients (6.1%) with no significant difference between the groups (p = 0.73, log-rank test). Symptom recurrence occurred significantly more often in patients without (5/18 patients; 27%) as compared to patients with ECG documentation (2/97 patients; 2.1%; p = 0.025). No correlation between age and success rate was found (p > 0.1). CONCLUSIONS: ESP ablation is effective and safe in patients with non-inducible AVNRT. Overall, recurrence of symptoms during long-term follow-up is low, even if no DAVNP is present. Tachycardia documentation before the EP study leads to a significantly lower recurrence rate following ESP ablation.
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BACKGROUND: The influence of power, duration and contact force (CF) on radiofrequency (RF) lesion formation is well known, whereas data on local impedance (LI) and electrode-tissue-coverage (ETC) is scarce. The objective was to investigate their effect on lesion formation in an ex vivo model. METHODS AND RESULTS: An ex vivo model was developed utilizing cross-sections of porcine heart preparations and a force-sensing, LI-measuring catheter. N = 72 lesion were created systematically varying ETC (minor/full), CF (1-5 g, 10-15 g, 20-25 g) and power (20 W, 30 W, 40 W, 50 W). In minor ETC, the distal tip of the catheter was in electric contact with the tissue, in full ETC the whole catheter tip was embedded within the tissue. Lesion size and all parameters were measured once per second (n = 3320). LI correlated strongly with lesion depth (r = -0.742 for ΔLI; r = 0.781 for %LI-drop). Lesions in full ETC were significantly wider and deeper compared to minor ETC (p < .001) and steam pops were more likely. Baseline LI, ΔLI, and %LI-drop were significantly higher in full ETC (p < .001). In lesions resulting in steam pops, baseline LI, and ΔLI were significantly higher. The influence of CF on lesion size was higher in minor ETC than in full ETC. CONCLUSIONS: ETC is a main determinant of lesion size and occurrence of steam pops. Baseline LI and LI-drop are useful surrogate parameters for real-time assessment of ETC and ΔLI correlates strongly with lesion size.
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Ablación por Catéter , Vapor , Porcinos , Animales , Impedancia Eléctrica , Ablación por Catéter/métodos , ElectrodosRESUMEN
BACKGROUND: The demand for transvenous lead extraction (TLE) has increased. In line with this, the safety of such procedures has also increased. Traditionally, TLE is performed under resource-intensive general anaesthesia. This study aims to evaluate the safety and outcomes of Cardiologist-lead deep sedation for TLE. METHODS: We retrospectively analysed 328 TLE procedures performed under deep sedation from 2016 to 2019. TLE procedures were performed by experienced electrophysiologists. Sedation was administered by a specifically trained cardiologist (bolus midazolam/fentanyl and propofol infusion). Procedural sedation data including blood pressure, medication administration and sedation time were collected. Complications related to sedation and the operative component of the procedure were analysed retrospectively. RESULTS: The sedation-associated complication rate during TLE was 22.0%. The most common complication (75% of complications) was hypotension requiring noradrenaline, followed by bradycardia requiring atropine (13% of complications). Additionally, the unplanned presence of an anaesthesiologist was needed in one case (0.3%). Deep sedation was achieved with midazolam (mean dose 42.9 ± 26.5 µg/kg), fentanyl (mean dose 0.4 ± 0.6 µg/kg) and propofol (mean dose 3.5 ± 1.2 mg/kg/h). There was no difference in medication dosage between those with a sedation-associated complication and those without. Sedation-associated complications appeared significantly more in patients with reduced LVEF (p = 0.01), renal impairment (p = 0.01) and a higher American Society of Anaesthesiologists (ASA) class (p = 0.01). CONCLUSION: Deep sedation for TLE can be safely performed by a specifically trained cardiologist, with a transition to general anaesthesia required in only 0.3% of cases. We continue to recommend the on-call availability of an anaesthesiologist and cardiac surgeon in case of major complications.
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AIMS: Battery electric vehicle (BEV) sales and use are rapidly expanding. Battery electric vehicles, along with their charging stations, are a potential source of electromagnetic interference (EMI) for patients with cardiac implantable electronic devices (CIEDs). The new 'high-power' charging stations have the potential to create strong electromagnetic fields and induce EMI in CIEDs, and their safety has not been evaluated. METHODS AND RESULTS: A total of 130 CIED patients performed 561 charges of four BEVs and a test vehicle (350â kW charge capacity) using high-power charging stations under continuous 6-lead electrocardiogram monitoring. The charging cable was placed directly over the CIED, and devices were programmed to maximize the chance of EMI detection. Cardiac implantable electronic devices were re-interrogated after patients charged all BEVs and the test vehicle for evidence of EMI. There were no incidences of EMI, specifically no over-sensing, pacing inhibition, inappropriate tachycardia detection, mode switching, or spontaneous reprogramming. The risk of EMI on a patient-based analysis is 0/130 [95% confidence interval (CI) 0%-2%], and the risk of EMI on a charge-based analysis is 0/561 (95% CI 0%-0.6%). The effective magnetic field along the charging cable was 38.65â µT and at the charging station was 77.9â µT. CONCLUSIONS: The use of electric cars with high-power chargers by patients with cardiac devices appears to be safe with no evidence of clinically relevant EMI. Reasonable caution, by minimizing the time spent in close proximity with the charging cables, is still advised as the occurrence of very rare events cannot be excluded from our results.
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Desfibriladores Implantables , Marcapaso Artificial , Humanos , Campos Electromagnéticos/efectos adversos , Suministros de Energía Eléctrica , CorazónRESUMEN
AIMS: This retrospective study sought to compare complication rates and efficacy of power-controlled very high-power short-duration (vHPSD) and conventional catheter ablation in a large cohort of patients with atrial fibrillation (AF). METHODS AND RESULTS: We analyzed 1115 consecutive patients with AF (38.7% paroxysmal, 61.3% persistent) who received first-time catheter ablation at our centre from 2015 to 2021. Circumferential pulmonary vein isolation ± additional substrate ablation using an irrigated-tip catheter was performed with vHPSD (70 W/5-7 s or 60 W/7-10 s) in 574 patients and with conventional power (30-35 W/15-30 s) in 541 patients. Baseline characteristics were well-balanced between groups (mean age 65.1 ± 11.2 years, 63.4% male). The 30-day incidence of cardiac tamponade [2/574 (0.35%) vs. 1/541 (0.18%), P = 0.598], pericardial effusion ≥ 10 mm [2/574 (0.35%) vs. 1/541 (0.18%), P = 0.598] and transient ischaemic attack [1/574 (0.17%) vs. 2/541 (0.37%), P = 0.529] was not significantly different between vHPSD and conventional ablation. No stroke, atrio-esophageal fistula, cardiac arrest or death occurred. Procedure (122.2 ± 46.8 min vs. 155.0 ± 50.5 min, P < 0.001), radiofrequency (22.4 ± 19.3 min vs. 52.9 ± 22.0 min, P < 0.001), and fluoroscopy (8.1 ± 7.2 vs. 9.2 ± 7.4, P = 0.016) duration were significantly shorter in the vHPSD group. At 12 months follow-up, freedom of any atrial arrhythmia was 44.1% vs. 34.2% (P = 0.010) in persistent AF and 78.1% vs. 70.2% in paroxysmal AF (P = 0.068). CONCLUSION: vHPSD ablation is as safe as conventional ablation and is associated with an improved long-term efficacy in persistent AF.
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Fibrilación Atrial , Ablación por Catéter , Venas Pulmonares , Humanos , Masculino , Persona de Mediana Edad , Anciano , Femenino , Fibrilación Atrial/diagnóstico , Fibrilación Atrial/cirugía , Estudios Retrospectivos , Resultado del Tratamiento , Catéteres , Venas Pulmonares/cirugía , Ablación por Catéter/efectos adversos , Ablación por Catéter/métodosRESUMEN
BACKGROUND: Pancreatic ductal adenocarcinoma (PDAC) lacks effective treatment options beyond chemotherapy. Although molecular subtypes such as classical and QM (quasi-mesenchymal)/basal-like with transcriptome-based distinct signatures have been identified, deduced therapeutic strategies and targets remain elusive. Gene expression data show enrichment of glycolytic genes in the more aggressive and therapy-resistant QM subtype. However, whether the glycolytic transcripts are translated into functional glycolysis that could further be explored for metabolic targeting in QM subtype is still not known. METHODS: We used different patient-derived PDAC model systems (conventional and primary patient-derived cells, patient-derived xenografts (PDX), and patient samples) and performed transcriptional and functional metabolic analysis. These included RNAseq and Illumina HT12 bead array, in vitro Seahorse metabolic flux assays and metabolic drug targeting, and in vivo hyperpolarized [1-13C]pyruvate and [1-13C]lactate magnetic resonance spectroscopy (HP-MRS) in PDAC xenografts. RESULTS: We found that glycolytic metabolic dependencies are not unambiguously functionally exposed in all QM PDACs. Metabolic analysis demonstrated functional metabolic heterogeneity in patient-derived primary cells and less so in conventional cell lines independent of molecular subtype. Importantly, we observed that the glycolytic product lactate is actively imported into the PDAC cells and used in mitochondrial oxidation in both classical and QM PDAC cells, although more actively in the QM cell lines. By using HP-MRS, we were able to noninvasively identify highly glycolytic PDAC xenografts by detecting the last glycolytic enzymatic step and prominent intra-tumoral [1-13C]pyruvate and [1-13C]lactate interconversion in vivo. CONCLUSION: Our study adds functional metabolic phenotyping to transcriptome-based analysis and proposes a functional approach to identify highly glycolytic PDACs as candidates for antimetabolic therapeutic avenues.
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Background: Femoral vascular access using the standard anatomic landmark-guided method is often limited by peripheral artery disease and obesity. We investigated the effect of ultrasound-guided vascular puncture (UGVP) on the rate of vascular complications in patients undergoing catheter ablation for atrial or ventricular arrhythmias. Methods: The data of 479 patients (59% male, mean age 68 years ± 11 years) undergoing catheter ablation for left atrial (n = 426; 89%), right atrial (n = 28; 6%) or ventricular arrhythmias (n = 28; 6%) were analyzed. All patients were on uninterrupted oral anticoagulants and heparin was administered intravenously during the procedure. Femoral access complications were compared between patients undergoing UGVP (n = 320; 67%) and patients undergoing a conventional approach (n = 159; 33%). Complication rates were also compared between patients with a BMI of >30 kg/m2 (n = 136) and patients with a BMI < 30 kg/m2 (n = 343). Results: Total vascular access complications including mild hematomas were n = 37 (7.7%). In the conventional group n = 17 (10.7%) and in the ultrasound (US) group n = 20 (6.3%) total vascular access complications occurred (OR 0.557, 95% CI 0.283−1.096). UGVP significantly reduced the risk of hematoma > 5 cm (OR 0.382, 95% CI 0.148, 0.988) or pseudoaneurysm (OR 0.160, 95% CI 0.032, 0.804). There was no significant difference between the groups regarding retroperitoneal hematomas or AV fistulas (p > 0.05). In patients with BMI > 30 kg/m2, UGVP led to a highly relevant reduction in the risk of total vascular access complications (OR 0.138, 95% CI 0.027, 0.659), hematomas > 5 cm (OR 0.051, 95% CI 0.000, 0.466) and pseudoaneurysms (OR 0.051, 95% CI 0.000, 0.466). Conclusion: UGVP significantly reduces vascular access complications. Patients with a BMI > 30 kg/m2 seem to particularly profit from a UGVP approach.