Major Periprocedural Complications Research Articles

In vivo safety and pulmonary vein isolation performance of a new cryoballoon for the treatment of atrial fibrillation.

Cryoablation to achieve pulmonary vein (PV) isolation has become one of the standard approaches for atrial fibrillation (AF) ablation. The Arctic Front series cryoballoon and Achieve circular mapping catheter (Medtronic) inherently possess design defects that have been associated with unfavorite clinical outcomes. Lately, a new cryoablation system (Nordica Cryoablation System, Synaptic Medical) was developed with improved design of the cryoballoon and circular mapping catheter to address the inadequacies of current cryoablation technology. An animal study was conducted to test the efficacy and safety in performing PVI with the Nordica Cryoablation System. Pulmonary vein isolation with the Nordica Cryoablation System was performed on 12 PVs of six healthy canines. Acute PVI and peri-procedural complications were recorded. All animals underwent a repeat EP study at least 4 weeks after index procedures followed by pathological and histological assessments of the heart and collateral/downstream organs after planned euthanasia. Acute PV isolation was achieved in all targeted PVs with 50% of PVs being isolated with a single cryoablation application. There were no major peri-procedural complications or device malfunction events. All PVs remained isolated after 29-30 days follow-up. Histological examination showed transmural cryo-lesions at treated sites with minimal inflammation, neovascularization, and neointima formation but no significant injury to adjacent tissue or embolization in downstream organs. Acute and durable PVI can be achieved by using the novel Nordica Cryoablation System. Ablation with this new cryoablation system is associated with transmural lesions at targeted myocardium but creates no injury to the collateral tissues or downstream organs.

Outcomes of patients with cardiac amyloidosis undergoing percutaneous left atrial appendage occlusion.

There is limited data on the safety and efficacy of left atrial appendage occlusion (LAAO) devices in patients with cardiac amyloidosis. We examined the outcomes of patients with cardiac amyloidosis undergoing LAAO device implantation in a nationally representative cohort of patients. The National Readmissions Database (NRD) was analyzed from 2016 to 2019 to identify patients ≥ 18 years old with atrial fibrillation (AF) undergoing LAAO. Patients were divided into those with cardiac amyloidosis and those without cardiac amyloidosis. A multivariable logistic regression model was utilized to assess the independent association of cardiac amyloidosis with in-hospital, 30-day/90-day/180-day outcomes after adjusting for confounders. Our cohort included 54,900 LAAO implantation procedures, of which 220 (0.4%) had cardiac amyloidosis. Patients with cardiac amyloidosis had a lower proportion of women and a lower prevalence of comorbidities including anemia, obesity, diabetes, and peripheral vascular disorders but a higher prevalence of stroke, as compared to those without cardiac amyloidosis. On multivariable analysis, cardiac amyloidosis was associated with significantly higher odds of peri-procedural major adverse events (adjusted odds ratio [aOR]: 2.69; 95% confidence interval [CI]: 1.41-5.14; p<0.01) and neurological complications (aOR: 5.48; 95% CI: 2.47-12.8; p<0.01). There was no difference in the odds of other peri-procedural complications, in-hospital mortality, hospital resource utilization, and 30/90/180-day all-cause/bleeding/stroke-related readmissions between both groups. Patients with cardiac amyloidosis undergoing LAAO device implantation have an increased risk of peri-procedural complications without any difference in bleeding/stroke-related readmissions. These hypothesis-generating findings need validation in future prospective studies.

Efficacy and safety of very high-power short-duration posterior wall ablation in persistent atrial fibrillation: a propensity score-matched comparison with standard power long-duration ablation

Abstract Background Catheter ablation (CA) with pulmonary vein isolation (PVI) is an optimal treatment option in patients with paroxysmal atrial fibrillation (AF). PVI alone in patients with persistent AF has proved to have suboptimal results. Ablation of additional atrial structures, such as posterior wall (PW) and left atrial appendage has been investigated as a tool to improve procedural efficacy. Recently very high-power short-duration (vHPSD) ablation was developed to allow rapid PVI, limiting complication through the maximization of resistive heating, and minimization of conductive heating. Objectives Compare PVI plus PWI using vHPSD versus standard-power (SP) ablation index-guided CA among consecutive patients with persistent AF Methods Forty consecutive patients underwent PVI plus PW isolation using vHPSD, compared to 40 controls underwent standard power (SP) PVI plus PW isolation. The primary efficacy endpoint outcome was recurrence of atrial tachyarrhythmias after a 3-month blanking period. The primary safety outcome was a composite of major complications within 30 days of CA. Results Treated patients have a median age of 62.8±9 years, 68 (85%) are male. Median left atrial volume is 42.4 (36-50) ml/m2. 61 (78.8%) patients had never undergone catheter ablation before. There are no statistically significant differences between groups. PW isolation was obtained more commonly in the vHPSD compared to the SP group (98% vs. 75%, p=0.007), despite shorter procedure and fluoroscopy times (p&amp;lt;0.001). Survival free from recurrent atrial tachyarrhythmias at 18 months was 68% in the vHPSD and 47% in SP groups, respectively (log-rank p=0.071), without major adverse events. The vHPSD approach was significantly associated with reduced risk of recurrent AF at multivariable analysis (HR, 0.39, p=0.030). Conclusions The results show feasibility and safety of posterior wall vHPSD ablation for persistent AF using this new temperature-controlled catheter without intraprocedural and periprocedural major complications at follow-up. vHPSD ablation for PW isolation may be more effective in term of atrial tachyarrhythmias recurrences with a trend for superior efficacy. However, this remains a single center experience in a small group of patients. Comparative trials involving greater number of patients with long-term follow-up are necessary to definitive results.

Multielectrode catheter-based pulsed electric field versus cryoballoon for atrial fibrillation ablation: a systematic review and meta-analysis

Abstract Background Pulsed field ablation (PFA) is an innovative technology recently adopted for the treatment of atrial fibrillation (AF). Preclinical and clinical studies have reported a remarkable safety profile, as a result of its tissue specific effect targeting cardiomyocytes and sparing adjacent tissues. The FarapulseTM system was the first PFA device to receive regulatory approval. Objective We performed a meta-analysis to compare the efficacy and safety of PFA with the FarapulseTM system versus currently available 2nd generation Cryoballoon technologies (CRYO). Methods We systematically searched electronic databases for studies focusing on AF ablation employing the FarapulseTM PFA or 2nd generation CRYO technologies. The primary endpoints were acute procedural success assessed on a vein and patient basis. Safety endpoints included overall periprocedural complications and major periprocedural complications. We also compared procedural, fluoroscopy times, and freedom from atrial tachyarrhythmias (ATs) at follow-up (secondary endpoints). Results Fifteen and 69 studies were included for PFA and CRYO, respectively. PFA demonstrated greater acute procedural success on a vein basis (99.9% vs 99%;p&amp;lt;0.001), as well as per patient (99.5% vs 98.4%;p&amp;lt;0.001). PFA yielded lower overall periprocedural complications (3.0% vs 5.7%;p&amp;lt;0.001) and shorter fluoroscopy time (14.0 min vs 18.9 min;p=0.02) compared to CRYO (Figure 1). No differences were found for major periprocedural complications (1.2% vs 1.0%;p=0.37), procedural time (84.4 min vs 106.2 min;p=0.07) (Figure1) and freedom from ATs at 1 year (81.8% vs 80.3%; Log-rank p =0.98) (Figure 2). Conclusions PFA contributed to higher acute procedural success, and safety compared to CRYO. No statistically significant differences in AT recurrence at 1-year follow-up were observed.Figure 1Figure 2

Impact of gender on the utilisation implantable cardioverter defibrillators and outcome: results from the German DEVICE registry

Abstract Background Implantable cardioverter defibrillators (ICD) are an established therapy for the primary and secondary prevention of sudden cardiac death. Real world data regarding the impact of gender on ICD implantation and outcome are scarce. Purpose To determine the impact of gender on the ICD implantation and outcome. Methods The German DEVICE registry is a prospective, nationwide database of ICD and CRT devices implantation and revisions. Between March 2007 and February 2014, 3794 patients undergoing a single or dual chamber ICD implantation and revisions were prospectively included in 44 centres and monitored for a median of 17 months. Herein we conducted the gender-based analysis of the ICD recipients. Results A total of 688 (18,1%) women (mean age 62.5 ± 16.0, median BMI 26.7) and 3106 men (mean age 64.6 ± 12.9, median BMI 26.8) were included in this registry. Significantly less women had coronary artery disease (p&amp;lt;0.001), while more women had hypertrophic cardiomyopathy (p=0.024) and primary electrical heart disease (p&amp;lt;0.001), mainly because of a higher incidence of long QT syndrome and arrhythmogenic right ventricular cardiomyopathy. There was a trend towards a higher rate dual chamber ICD in the female population (31.7% vs. 28.1%; p=0.061). Women were less likely to undergo ambulatory interventions (6.4% vs. 9.0%; p=0.026) and had a trend towards higher rate of ICD implantation for secondary prevention (52.3% vs. 48.7%; p=0.086). Females were more likely to have a history of ventricular fibrillation (51.7% vs. 39.4%; p&amp;lt;0.001) and resuscitation (54.7% vs. 46.3%; p=0.006), but less likely to have a history of ventricular tachycardia (33.1% vs. 45.2%; p&amp;lt;0.001). The overall rate of in-hospital complications (5.3% vs. 2.7%; p=0.005) as well as the rate of major periprocedural complications (3.1% vs. 1.3%; p=0.002) was significantly higher among females, mainly driven by a higher incidence of pneumothorax (1.0% vs. 0.1%; p=0.004) and haemothorax (0.4% vs. 0%; p=0.02). The rate of in-hospital device revision and mortality were similar between genders. The Kaplan-Meier estimated 1-year all-cause mortality was 5.2% for women and 7.1% for men (p=0.073; Fig 1), while the estimated incidence of all-cause mortality or device shocks was significantly lower in the female population (15.1% vs. 19.0%; p=0.02). Women were more likely to undergo resuscitation during follow-up (FU; 1.3% vs. 0.3%; p&amp;lt;0.001) and showed a higher fear of receiving device shocks. There was no difference in terms of ICD-shocks, VT-storm and ablation rates at FU. The all- cause, device-related, and other cardiovascular rehospitalisation rates and the incidence of non-arrhythmic adverse events during FU were similar between genders. Conclusions In this real-life patient cohort only a minority of patients were females. Female patients had a higher risk of major periprocedural complications and in-hospital complications and a trend towards a lower all-cause mortality during FU.Fig 1. Kaplan-Meier estimated survival.

Procedural characteristics, details on epicardial mapping-based lesion transmurality, and long-term success of posterior wall isolation with a pentaspline pulsed field ablation device

Abstract Background Achieving durable posterior wall isolation (PWI) with thermal-based energies is challenging, as reconnection rates have been reported to be up to 60%. Additionally, PWI can significantly increase the risk of collateral thermal damage to the esophagus. Pulsed field ablation (PFA) is a non-thermal energy source with a remarkable safety profile due to its selectivity to cardiac tissue. Additionally, PWI durability was reported to be 100% in a recent phase-3 study enrolling persistent AF patients undergoing PFA via the FarapulseTM system. Purpose To report procedural details, acute lesion transmurality, and long-term success of PWI via the FarapulseTMsystem. Methods Consecutive persistent AF patients undergoing first-time ablation with the FarapulseTM system at four different centres were prospectively enrolled. All patients received first-time pulmonary vein isolation (PVI) and PWI. PFA was performed with either a 31mm or a 35mm device and an energy output of 2.0kV. At least 2 applications per position were delivered. Primary efficacy endpoint was freedom from any atrial tachyarrhythmia &amp;gt;30s after a 3month blanking period. PW lesion transmurality was assessed in a subpopulation of patients with an indication for hybrid AF ablation and left atrial appendage (LAA) clipping. The procedure was performed according to the following steps: 1) endocardial PVI plus PWI via the FarapulseTM system; 2) endocardial high-density mapping with RhythmiaTM plus Intellanav OrionTM; 3) thoracoscopy-assisted epicardial high-density mapping with Intellanav OrionTM 4) left atrial appendage clipping. Results 157 persistent AF patients (mean age: 62±11years; 75.5% males) were included. First-pass PVI was achieved in 100% of patients. On average, pulsed electric field applications for PWI were 16.3±2.4. Mean procedural time was 66±17min; left atrial dwelling and fluoroscopy times were 46±12min and 14±6min, respectively. SR restoration during PWI was observed in 8 (5.1%) cases. Minor and major periprocedural complications occurred in 2.5% (groin hematoma: 4pts) and 0.6% (diplopia with negative cerebral MRI) patients, respectively. During a mean follow-up of 353±58 days, arrhythmia-free survival was 78.3% (n=123). A redo ablation was performed in 23 patients, showing reconnection of 22.8% of PVs. Durable PWI was observed in 82.6% of patients. In the subpopulation of patients (n=3) undergoing hybrid ablation plus LAA clipping, thoracoscopy-guided epicardial mapping of the PW was performed between 57 and 72 minutes after the last endocardial PFA application. All patients showed transmural PWI (Figure1). Conclusions In a real-world multicenter registry, PWI by means of the FarapulseTM system was safe and feasible, contributing to approximately 80% success rate after 1 year. Endocardial PFA-based PWI led to 100% transmural lesions acutely, with a rate of reconnection &amp;lt;20% at redo procedures.

Gender matters. Impact of gender on the utilization of defibrillators with cardiac resynchronisation therapy and outcome: results from the German DEVICE registry

Abstract Background Defibrillators with cardiac resynchronisation therapy (CRT-Ds) are widely used in patients with left ventricular (LV) systolic dysfunction and high-grade intraventricular conduction delays. Real world data regarding the impact of gender on CRT-D implantation and outcome are scarce. Purpose To determine the impact of gender on the CRT-D devices implantation and outcome. Methods The German DEVICE registry is a prospective, nationwide database of ICD and CRT devices implantations and revisions. A total of 1536 patients undergoing CRT-D implantations and revisions were included between March 2007 and February 2014 in 44 centres and monitored for a median of 17.2 months. Herein we conducted the gender-based analysis of the CRT-D recipients. Results Only a minority of the patients in this registry was females (329; 21,4%). The demographic data (age and BMI) were similar between genders. The female population was less likely to have a coronary artery disease (35.3% vs. 56.7%; p&amp;lt;0.001), but more likely to have dilated cardiomyopathy (61.1% vs. 49.5%; p&amp;lt;0.001). Significantly less women had a LVEF ≤ 35% (90.6% vs. 94.8%, p=0.005). A total of 84.2% of females and 80.2% of males received a device for the primary prevention of sudden cardiac death (SCD; p=0.10). Women were more likely to have a history of ventricular fibrillation (44.2% vs. 23.0%, p=0.002) and resuscitation (p=0.01), but less likely to have a history of ventricular tachycardia (44.2% vs. 61.9%; p=0.019). Significantly more women than men showed a left bundle branch block at implantation (89.7% vs. 80.9%, p&amp;lt;0.001). A QRS duration of at ≥ 150 ms was noted in 74.8% of women and 71.5% of men (p=0.25), while significantly more women had a QRS of ≥ 120 ms (97.0% vs. 94.2%; p=0.043). The overall incidence of major periprocedural complications and in hospital complications was similar between groups (3.6% vs 2.4%, p=0.25 and 6.0% vs. 5.8%, p=0.88 respectively), however a pneumothorax requiring intervention was more common among women (1.8% vs. 0.5%, p=0.027). The rate of device revision until discharge and the in-hospital mortality did not differ between genders. The Kaplan-Meier estimated 1-year all-cause mortality was 6.3% for women and 8.2% for men (p=0.25, Fig.1), while the estimated incidence of death or defibrillator shocks was 11.0% and 15.1%, respectively (p=0.051). The non-lethal complications and device revisions during follow-up (FU) were similar between genders. Women showed a lower non-device-dependent cardiovascular hospitalisation rate (8.2% vs. 13.1%; p=0.043) and had more fear of receiving a device shock than men (p=0.002). Conclusions In this real-life CRT-D patient cohort only a minority of patients were females. Women had a higher rate of pneumothorax requiring intervention. The 1-year mortality and the complications during FU were similar between genders. Women had a lower rate of non-device-dependent cardiovascular hospitalisation during FU.Fig.1. Kaplan-Meier estimated survival.

DECENNIAL ANALYSIS OF AVNRT ABLATION IN A SINGLE CENTRE

Abstract Background Transcatheter ablation represents the first line therapy for atrio–ventricular nodal re–entrant tachycardia (AVNRT). Both radiofrequency (RF) and cryoablation (CRYO) have been shown to be effective, with a better safety profile for CRYO. Data on very long–term efficacy are scarces. Purpose To review our experience in AVNRT ablation performed in the last ten years and evaluate safety, efficacy and very long–term outcome of RF and CRYO. Methods We retrospectively analyzed all patients who underwent AVNRT ablation (RF or CRYO) between January 2013 and May 2023 at our centre. The majority of procedures were performed under electro–anatomical mapping (EAM) guidance to reduce radiation exposure. Acute efficacy endpoint was defined as slow pathway ablation, while long–term outcome was defined as the absence of AVNRT recurrence. Results A total of 387 consecutive patients (60,5% F; mean age 48 ± 19 years) were included; CRYO was performed in 241 patients (62%), RF in 131 patients (34%), hybrid approach (CRYO+RF) in 15 patients (4%). AVNRT induction was obtained during EPS in 295 cases (76%), in 25,4% after isoprotenerol administration. No significant differences for baseline characteristics were observed between the two groups except for age (CRYO: 42,2 ± 18 years vs RF 57,19 ± 16,5 years p &amp;lt;0.001). In pediatric population CRYO was performed in 93% of procedures. Figure 1 shows the distribution of RF/CRYO over 10 years at our centre, with a trend of significant increase in CRYO utilizations in the last years. Acute success was achieved in all 387 cases (100%; delta WP 28,5 ± 23,1 ms, delta AVN ERP 72,4 ± 44,7 ms). No permanent AV block or major periprocedural complications occurred, however transient AH prolongation was observed in 0.8% in CRYO pts vs 2,8% RF pts. The mean follow–up was 73±45 months, range 6–129 months. Overall long–term success rate was 93,3%, ranging from 91,3 % in CRYO and 96,6% in RF. Recurrence occurred in 26 cases (6,7%) after a median time of 20 months (4–40months). Recurrent AVNRT were treated with RF in the majority of cases, CRYO in 6 procedures, hybrid in only 1 case. Conclusions Transcatheter ablation is a safe and effective therapy for AVNRT. Our very long–term outcome data confirmed very high success rate even after 10 years follow–up. The increasing choice for CRYO may be due to the increasing number of pediatric and young patient referred to our centre.

Pulsed field ablation technology for pulmonary vein and left atrial posterior wall isolation in patients with persistent atrial fibrillation.

Limited data exist on pulsed-field ablation (PFA) in patients with persistent atrial fibrillation (PeAF) undergoing left atrial posterior wall isolation (LAPWI). The Advanced TecHnologies For SuccEssful AblatioN of AF in Clinical Practice (ATHENA) prospective registry included consecutive patients referred for PeAF catheter ablation at 9 Italian centers, treated with the FARAPULSETM-PFA system. The primary efficacy and safety study endpoints were the acute LAPWI rate, freedom from arrhythmic recurrences and the incidence of major periprocedural complications. Patients undergoing pulmonary vein isolation (PVI) alone, PWI + LAPWI and redo procedures were compared. Among 249 patients, 21.7% had long-standing PeAF, 79.5% were male; mean age was 63 ± 9 years. LAPWI was performed in 57.6% of cases, with 15.3% being redo procedures. Median skin-to-skin times (PVI-only 68 [60-90] vs. PVI + LAPWI 70 [59-88] mins) did not differ between groups. 45.8% LAPWI cases were approached with a 3D-mapping system, and 37.3% with intracardiac echocardiography. LAPWI was achieved in all patients by means of PFA alone, in 88.8% cases at first pass. LAPWI was validated either by an Ultrahigh-density mapping system or by recording electrical activity + pacing maneuvers. No major complications occurred, while 2.4% minor complications were detected. During a median follow-up of 273 [191-379] days, 41 patients (16.5%) experienced an arrhythmic recurrence after the 90-day blanking period, with a mean time to recurrence of 223 ± 100 days and no differences among ablation strategies. LAPWI with PFA demonstrates feasibility, rapidity, and safety in real-world practice, offering a viable alternative for PeAF patients. LAPWI is achievable even with a fluoroscopy-only method and does not significantly extend overall procedural times.

Combining catheter ablation and left atrial appendage occlusion in high-risk patients with atrial fibrillation: a propensity score-matched analysis

BackgroundThe safety and efficacy of a combined approach of catheter ablation (CA) and left atrial appendage occlusion (LAAO) compared to LAAO alone remain unknown. MethodsPatients with atrial fibrillation (AF) at increased stroke risk who underwent LAAO were divided into either combined (CA and LAAO) procedures or LAAO alone group. Propensity score matching was utilized to balance baseline characteristics. The primary endpoint of the study was a composite of death, thromboembolic events, major bleeding, heart failure (HF) rehospitalization, and major periprocedural complications. ResultsA total of 707 AF patients who underwent LAAO were included. After 1:1 propensity score matching, 166 patients who underwent LAAO alone (n = 83) or the combined procedure (n = 83) were analyzed. Successful LAAO was achieved in all (100%) patients, with a low incidence of periprocedural complications in both groups (2.4% vs. 4.8%, LAAO vs. combined, p = 0.68). The incidence of peri-device leak post-LAAO was significantly higher in the combined group (25.3% vs. 43.4%, p = 0.01). After a median follow-up of 2 years, there were no significant differences in the rates of the primary composite endpoint between the two strategies (22.2% vs. 14.3%, HR: 1.24 [95% CI: 0.51–2.97], p = 0.63). However, the rate of HF rehospitalization was significantly lower in the combined group (19.6% vs. 3.6%, HR: 4.89 [95% CI: 1.50–15.97], p = 0.024). ConclusionsCombining CA and LAAO in a “one-stop” approach is safe and brings additional benefits in relieving symptoms of heart failure, although peri-device leak was more common compared to LAAO alone.

Do We Need Fasting Prior to Coronary Angiography? The CORO-NF Randomized Pragmatic Study

BackgroundSimilar to procedures requiring general anesthesia, current guidelines recommend fasting for 6 hours for solids and for 2 hours for liquids prior to coronary angiography, but without data supporting such recommendation. The CORO-NF study aimed at assessing whether a shorter fasting period prior to elective coronary angiography associates with improved patient satisfaction without more complications compared with the standard fasting approach. MethodsWe conducted a single-center, randomized, prospective, pragmatic study in 2 sequential phases: a “conventional protocol phase,” continuing the usual practice (F Group); and an “experimental phase” (NF Group), reducing minimum fasting duration to 2 hours. Patients received a questionnaire to express a satisfaction score ranging from 1 (maximum complain/no approval) to 5 (minimum or no complain/full approval). All patients admitted acutely were enrolled in a control A Group registry. Fasting time and every major complication and periprocedural complications were analyzed. ResultsFasting time was 821 ± 357 minutes in the F Group and 230 ± 146 minutes in the NF Group (P < .001). The satisfaction score was higher in the NF Group (4.2 ± 0.7 vs 2.9 ± 1.2, P < .001), even at multivariable analysis considering fasting time (P < .001). No intraprocedural food ingestion-related adverse events occurred in either of the 2 experimental groups, as well as in the parallel A Group, with no excess of peri- and postprocedural complications in the NF Group. ConclusionsThe significantly higher satisfaction scores among patients undergoing a shorter-than-recommended fasting period prior to coronary angiography, not counterbalanced by decreased safety, underscores the potential benefits of revising the traditional 6-hour fasting protocols.

Pelvic AVM Embolization: A Tricky Affair-Multicenter Retrospective Experience.

Pelvic arteriovenous malformations (pAVMs) are congenital or acquired vascular anomalies, presenting with hematuria, menometrorrhagia, pelvic pain, and varices; they can be life-threatening in case of rupture. Surgical therapies have been proposed but endovascular embolization has been recognized as the primary modality. The aim of this article was to report a retrospective multicenter experience concerning embolization of pelvic AVMs and provide literature overview. We describe 18 patients (14 female and 4 male) diagnosed with pAVM and treated with minimally invasive methods. The pre-procedural imaging evaluation was based on transpelvic and/or transvaginal color Doppler ultrasound, contrast-enhanced computed tomography, and/or magnetic resonance. In 3 cases, the malformation was congenital and in other 15, acquired. Most common symptoms were menometrorrhagia, hematuria, pelvic pain and pressure, and heaviness in the lower abdominal region. In 10 cases (56%), only 1 procedure was required. Eight patients underwent multistage treatment. Complete occlusion of the lesion in post-procedural angiography was observed in 12 patients (67%). No major periprocedural complications were observed. In 14 cases (78%), both satisfactory embolization and significant clinical improvement was achieved in long-term follow-up. Sixteen patients (88%) were at least satisfied with the clinical outcome. One patient reported subsequent successful pregnancy 5 years after the treatment. Hemodynamics of pAVM are variable and thorough understanding of the vessel anatomy is crucial in planning and choosing proper treatment. Both transarterial and percutaneous direct puncture embolization strategies appear safe, technically feasible, and clinically effective. In this manuscript, we discuss the role of interventional radiology methods in the treatment of pelvic arteriovenous malformations along with its advantages, limitations and possible complications. In addition to this, we review the current literature and confront our findings with those made by other authors. We believe that modern endovascular methods offer safe and reliable alternative for traditional surgical therapy and should be therefore considered during multidisciplinary treatment of these patients.

Atrial Fibrillation Ablation with a Novel Fully 3D-Mapping-Integrated Multi-Electrode Radiofrequency Balloon Catheter.

Pulmonary vein isolation (PVI), as the cornerstone of atrial fibrillation (AF) ablation, has emerged a widely used therapy for patients suffering from AF. To improve PVI efficiency, single-shot catheters (SSCs) have been developed. Regrettably, SSCs are not integrated into 3D-mapping technology. In that regard, a novel radiofrequency balloon catheter (RFBC, Heliostar, Biosense Webster) with full integration into 3D-mapping technology has been developed. The aim of this study was to assess operative and follow-up outcomes of the RFBC in AF patients. In this monocentric prospective registry, patients with a first-time PVI using the RFBC were included. Follow-up visits were scheduled 3, 6, 12 and 24 months after ablation and in case of symptoms. A total of 171 patients (36.8% female) were included, with a mean age of 68.5 ± 10.2 years. Among them, 63 patients (36.8%) presented with persistent AF. Notably, no major periprocedural complications were observed. The mean follow-up period was 287 ± 157 days. In the Kaplan-Meier analysis, the estimated recurrence-free survival after 12 months was 81.8%. Based on our data, PVI with the fully 3D-mapping-integrated RFBC seems to be safe and effective and to have a favorable 12-month outcome in patients with paroxysmal and persistent AF.

Major in-hospital complications after catheter ablation of cardiac arrhythmias: individual case analysis of 43 031 procedures.

In-hospital complications of catheter ablation for atrial fibrillation (AF), atrial flutter (AFL), and ventricular tachycardia (VT) may be overestimated by analyses of administrative data. We determined the incidences of in-hospital mortality, major bleeding, and stroke around AF, AFL, and VT ablations in four German tertiary centres between 2005 and 2020. All cases were coded by the G-DRG- and OPS-systems. Uniform code search terms were applied defining both the types of ablations for AF, AFL, and VT and the occurrence of major adverse events including femoral vascular complications, iatrogenic tamponade, stroke, and in-hospital death. Importantly, all complications were individually reviewed based on patient-level source records. Overall, 43 031 ablations were analysed (30 361 AF; 9364 AFL; 3306 VT). The number of ablations/year more than doubled from 2005 (n = 1569) to 2020 (n = 3317) with 3 times and 2.5 times more AF and VT ablations in 2020 (n = 2404 and n = 301, respectively) as compared to 2005 (n = 817 and n = 120, respectively), but a rather stable number of AFL ablations (n = 554 vs. n = 612). Major peri-procedural complications occurred in 594 (1.4%) patients. Complication rates were 1.1% (n = 325) for AF, 1.0% (n = 95) for AFL, and 5.3% (n = 175) for VT. With an increase in complex AF/VT procedures, the overall complication rate significantly increased (0.76% in 2005 vs. 1.81% in 2020; P = 0.004); but remained low over time. Following patient-adjudication, all in-hospital cardiac tamponades (0.7%) and strokes (0.2%) were related to ablation. Major femoral vascular complications requiring surgical intervention occurred in 0.4% of all patients. The in-hospital mortality rate adjudicated to be ablation-related was lower than the coded mortality rate: AF: 0.03% vs. 0.04%; AFL: 0.04% vs. 0.14%; VT: 0.42% vs. 1.48%. Major adverse events are low and comparable after catheter ablation for AFL and AF (∼1.0%), whereas they are five times higher for VT ablations. In the presence of an increase in complex ablation procedures, a moderate but significant increase in overall complications from 2005-20 was observed. Individual case analysis demonstrated a lower than coded ablation-related in-hospital mortality. This highlights the importance of individual case adjudication when analysing administrative data.

Comparing safety and efficacy: MemoLefort versus watchman for left atrial appendage closure

BackgroundThe MemoLefort is a new plug occluder for left atrial appendage closure (LAAC) in patients with atrial fibrillation (AF). This study compares the safety and efficacy of MemoLefort and the well-established Watchman occluder for LAAC. MethodsBetween January 2021 and September 2022, a cohort of 189 consecutive patients who underwent LAAC with MemoLefort or Watchman at The Second Affiliated Hospital of Wenzhou Medical University were included. Patients with MemoLefort or Watchman devices were compared in terms of the primary safety endpoints encompassing major periprocedural complications and major bleeding events at follow-up, the primary efficacy endpoint of all-cause stroke, systemic embolism and cardiovascular/unexplained death, and the combined hazard endpoint, a composite of all the above-mentioned hazards. ResultsOf the MemoLefort group (n = 83) and Watchman group (n = 106), the mean age, CHA2DS2-VASc score, and HAS-BLED score were 67.6 ± 9.2 vs. 69.0 ± 10.6 years, 3.9 ± 1.9 vs. 3.8 ± 1.9, and 1.6 ± 1.0 vs. 1.7 ± 1.2, respectively. After a median follow-up duration of 198 (99–329) vs. 334 (171–497) days, the primary endpoints of efficacy [2/49, 4.1% (MemoLefort) vs. 2/97, 2.1% (Watchman); hazard ratio (HR), 1.50; 95% confidence interval (CI), 0.20–11.08; P = 0.68] and safety (1/49, 2.0% vs. 5/97, 5.2%; HR, 0.26; 95% CI, 0.05–1.31; P = 0.19), as well as the combined hazard endpoint (3/49, 61% vs. 6/97, 6.2%; HR, 0.70; 95% CI, 0.18–2.58; P = 0.59) were similar between groups. ConclusionsIn the short term, LAAC with MemoLefort provided similar efficacy, safety, and net clinical benefit in comparison to Watchman devices.

Modified sympathicotomy in patients with refractory ventricular tachycardia and structural heart disease: a single-center experience.

Modified cardiac sympathetic denervation (CSD) with stellate ganglion (SG) sparing is a novel technique for cardiac neuromodulation in patients with refractory ventricular tachycardia (VT). Our aim is to describe the mid- to long-term clinical outcome of the modified CSD with SG sparing in a series of patients with structural heart disease (SHD) and refractory VT. All consecutive patients with SHD and refractory VT undergoing modified CSD were enrolled. Baseline clinical characteristics and periprocedural data were collected for all patients. The primary outcome was any recurrence of sustained VT. We enrolled 15 patients (age: 69.2 ± 7.9years; male 100%) undergoing modified CSD. Left ventricular ejection fraction was 37 ± 11% and all patients had an implantable cardiac defibrillator (ICD); the underlying cardiomyopathy was non-ischemic in 73.3% of them. At least one previous ablation had been attempted in 66.6% of cases. The 73.3% of patients underwent bilateral CSD and the mean effective surgical time was 10.8 ± 2.4min per side; no major periprocedural complication occurred. After a median follow-up time of 15months (IQR: 8.5-24.5months), the primary outcome occurred in 47.6% of cases. All patients experienced a reduction of ICD shocks after CSD (3.1 ICD shocks/patient before vs. 0.3 ICD shocks/patient after CSD; p-value: 0.001). Bilateral CSD and a VT cycle length < 340ms were associated with better outcomes. A modified CSD approach with stellate ganglion sparing appears to be safe, fast, and effective in the treatment of patients with SHD and refractory VTs.

Atrioventricular-synchronous leadless pacemakers: a single center experience

Abstract Background Leadless pacemakers allow atrioventricular (AV) synchronous pacing using a new software to detect atrial contraction with a 3- axis accelerometer. Notwithstanding, evidence supporting its use is still scarce and only limited real-world data have been reported. Aim To evaluate the feasibility and to describe pacing outcomes of AV-synchronous leadless pacemakers. Methods Consecutive patients with AV block referred to leadless pacemaker MicraTM at single center between June 2020 and November 2022 were retrospectively included. Patients were evaluated at two distinct times during follow-up and parameters from sensed atrial tracking were calculated: tracking index (atrial mechanical sense followed by ventricular pace [AM-VP] divided by total VP) and total AV synchrony (sum of AM-ventricular sense [AM-VS], AM-VP, and AV conduction mode switch). Results A total of 43 patients (mean age 78 ± 11 years; 72% male) were included. Pacing indication was complete AV block in 29 patients (67%) and high-grade AV block in the remaining 14 (33%). Mean implantation and fluoroscopy times were 48 ± 22 minutes and 4.5 ± 3.9 minutes, respectively. One major peri-procedural complication was reported: a cardiac tamponade, treated with pericardiocentesis. The first outpatient visit occurred at a mean follow-up of 3.2 ± 4.1 months after the implantation procedure. Overall, at the first screening, 47% of patients required at least 50% pacing; mean tracking index was 65 ± 16% and mean total AV synchrony was 80 ± 18%. Specific pacemaker parameters were adjusted according to physician’s discretion, namely A3 and A4 thresholds and A3 window. Thirty-seven patients performed 2 follow-up visits, 8 ± 5 months after the first visit. In comparative analysis between both follow up times, mean total AV synchrony remained stable (80 ± 17% vs. 80 ± 15%, p=0.970) and there was a numerical improvement of tracking index by 6 ± 13% (65 ± 15% vs. 71 ± 16%, p=0,059). During the follow-up, 7 patients (16%) died, none related to the procedure nor the device. Conclusions Implantation of AV-synchronous leadless pacemakers is feasible and safe. In our cohort, there was a numerical increased of atrial tracking and a stability of AV synchrony during follow-up.

Clinical and imaging outcomes of 100 patients with cerebrospinal fluid-venous fistulas treated by transvenous embolization

BackgroundCerebrospinal fluid-venous fistulas (CSFVF) are a common cause of spontaneous intracranial hypotension (SIH). Transvenous embolization has emerged as a reliable treatment option. We review the clinical presentation, imaging, and clinical...

Catheter ablation of atrial fibrillation in elderly and very elderly patients: safety, outcomes, and quality of life.

Atrial fibrillation (AF) risk increases with age. We aim to assess the efficacy and safety of catheter ablation in the older population. All patients undergoing AF ablation (2013-2021) at our institution were enrolled in a prospectively maintained registry. The primary endpoint was AF recurrence. Patients were divided into 3 groups: non-elderly (< 65 years), elderly (65-75 years), and very elderly (> 75 years). Patient surveys at baseline and during follow-up were used to calculatequality of life (QoL)metrics: the AF severity score as well as the AF burden. A total of 7020 patients were included (42% non-elderly, 42% elderly, and 16% very elderly). Periprocedural major complications were low (< 1.5%) and similar in all groups besides pericardial effusion which was more frequent with older age and similar between the elderly and very elderly. At 3 years, AF recurrence for persistent AF (PersAF) was highest in the very elderly group (48%), followed by the elderly group (42%), and was the lowest in the non-elderly group (36%). In paroxysmal AF (PAF), there was no difference in AF recurrence between the elderly and non-elderly, while the very elderly remained associated with a significantly increased risk. Multivariable Cox analysis confirmed these findings (PersAF; elderly: HR = 1.23, P = 0.003; very elderly: HR = 1.44, P < 0.001) (PAF; elderly: HR = 1.04, P = 0.62; very elderly: HR = 1.30, P = 0.01). Catheter ablation resulted in a significant improvement in quality of life, irrespective of age group. Catheter ablation in elderly and very elderly patients is safe, efficacious, and associated with QoL benefits. Overall, major complications were minimal and did not differ significantly between age groups, with the exception of pericardial effusions which were higher in the elderly and very elderly compared to non-elderly adults. Very elderly patients had a higher rate of AF recurrence when compared with elderly or non-elderly patients. Nevertheless, ablation resulted in a remarkable improvement in QoL and a reduction of AF burden and AF symptoms with a similar magnitude, irrespective of age.

Leadless Pacemaker Implantation, Focusing on Patients With Conduction System Disorders Post–Transcatheter Aortic Valve Replacement: A Retrospective Analysis

BackgroundImpairment of the conduction system is a common complication of transcatheter aortic valve replacement (TAVR), which is typically performed in elderly patients. A leadless pacemaker (LP) may be a suitable option in this frail population, but the available scientific data concerning the efficacy and safety of leadless pacing after TAVR are sparse. The purpose of this analysis was to evaluate the efficacy and safety of LP implantation in patients with relevant bradycardias after TAVR, compared to other indications. MethodsConsecutive patients were retrospectively enrolled. Demographics, background heart diseases, interventional parameters, and follow-up data were collected. ResultsA total of 257 consecutive patients who underwent LP implantation were included. In 26 patients, the device was implanted due to bradycardias after TAVR (TAVR group), whereas the remaining 231 patients were in the population without previous TAVR (non-TAVR group). The mean implantation duration (56 ± 22 minutes in the TAVR group vs 48 ± 20 minutes in the non-TAVR group; P = not significant [NS]) and the implantation success rate (100% in the TAVR group vs 98.7% in the non-TAVR group; P = NS) were similar in the 2 cohorts. No significant differences occurred in pacing parameters (sensing, impedance, and threshold, respectively) between the 2 groups, either at implantation or during follow-up. A total of 8 major periprocedural complications (3.1% of patients in total; 3.8% in the TAVR group vs 3.0% in the non-TAVR group; P = NS) occurred within 30 days, without significant difference between the 2 groups. ConclusionsLP implantation appears to be safe and effective in patients after TAVR, and therefore, this procedure is a suitable option for this often old and frail population.