Procedure-related Major Adverse Events Research Articles

Feasibility and efficacy assessment of a novel size-adjustable cryoballoon for ablation of atrial fibrillation in a multicenter clinical setting

Abstract Background The POLARx-FIT cryoballoon (CB) system introduces a unique feature, allowing the selection of two distinct balloon sizes within a single catheter. This innovation holds promise for treating larger pulmonary veins (PV), providing increased flexibility to achieve optimal occlusions. However, there is a scarcity of clinical data supporting its application in this context. Purpose To compare the benefits and safety of the new POLARx-FIT system to those of the existing POLARx system currently in use for PV isolation (PVI) in patients with atrial fibrillation (AF). Methods The first 140 consecutive patients who underwent CB-based PVI with the POLARx-FIT system were retrospectively compared with 300 consecutive patients treated with the POLARx system. Protocol-directed cryoablation was delivered for 180 sec or 240 sec according to operator’s preference for isolation achieved in ≤60 sec, or 240 sec if isolation occurred >60 sec or when time to isolation was not available. The ablation endpoint was PVI as assessed by entrance and exit block. In the POLARx-FIT group the choice of balloon size (28 or 31 mm) was determined during the procedure while attempting to occlude each vein. Results Two-thousand one-hundred fifty-five cryo-applications (CBA) from 440 patients were analysed (300, 68.2% POLARx; 140, 31.8% POLARx-FIT). PVI was achieved with cryoablation only in all patients. The mean number of freeze applications per patient was similar between groups (5.0±1.4 in the POLARx-FIT vs 5.3±1.8 in the POLARx group, p=0.207) whereas the number of PVs treated in a single-shot fashion was higher in the POLARx-FIT group (444, 80.7% with one shot; 75, 13.7% with 2 shots; 31, 5.6% with more than 2 shots) than in the POLARx one (1168, 70.2% with one shot, p=0.0002; 294, 17.7% with two shots and 143, 8.6% with more than two shots). Among the POLARx-FIT cases, in 54.2% (n=298) of applications, the 31-mm diameter was employed as a first choice, while in the remaining 45.8% (n=252) of applications, the 28-mm diameter was adopted. A switch to a different balloon diameter was applied in 11.6% of cases. The first pass isolation (i.e. a single shot CBA to achieve PVI) was slightly higher when using a 31 mm diameter (n=250, 83.9%) than a 28 mm diameter (n=194, 77.0%, p=0.05). Three (0.7%) transient phrenic nerve palsy were observed (all in the POLARx group, 0.9%, p=0.554), with full recovery in the 48-h post procedure; no major procedure-related adverse events were reported at 30 days post-procedure. Conclusion In this first multicentric experience in a clinical practice setting, this novel cryo-balloon system proved to be safe and effective and resulted in a high proportion of successful single-freeze isolation. The intraprocedural flexibility of balloon size contributed to its versatility, leading to a variation in balloon diameter in about 12% of freeze applications.

A comparison of procedure-related adverse events between two right ventricular leadless pacemakers.

The Medtronic Micra VR and Abbott AVEIR VR are the leadless pacemakers (LPM) currently available in the United States (US). Micra VR employs fixation tines and the AVEIR VR uses an active fixation helix. Micra VR requires fixation before electrical measurements are obtained, while R-waves may be mapped by AVEIR VR without fixation. Little comparative data is available for these LPMs. Accordingly, we compared the incidences of procedure-related major adverse clinical events (MACE) and device problems in the US for Micra VR and AVEIR VR during 2022-2024. We searched the FDA's Manufacturer and User Facility Device Experience (MAUDE) database for US reports of MACE and device problems that were filed from April 2022 to December 2023 for AVEIR VR, and from June 2022 to April 2024 for Micra VR. Totals for US-registered LPM implants were obtained from the manufacturers' product performance reports. During the study period, 5990 AVEIR VR and 10 940 Micra VR implants were registered in the US. We found 305 MAUDE reports for AVEIR VR (5.1%), versus 541 MAUDE reports for Micra VR (4.9%) (p = .702). The incidence of MACE was 0.72% (43/5990) for AVEIR VR versus 0.59% (65/10 940) for Micra VR, (p = .387). The incidences of procedure-related death, cardiac perforation. cardiac arrest, emergency pericardial drainage or reparative surgery were similar for both LPMs (p > .05). Micra VR had more unacceptable thresholds requiring LPM replacement compared to AVEIR VR (95;0.9% vs. 24;0.4%; p = .001). AVEIR VR had a statistically higher incidence of device dislodgement during (32) and after (21) implant compared to Micra VR (53 (0.9%) vs. 46 (0.4%), p < .001). Micra VR and AVEIR VR have similar procedural safety profiles, including the incidences of death and perforation. However, device problems differed significantly, possibly related to their design differences. Compared to Micra VR, AVEIR VR appears to have an advantageous threshold measurement capability but is more prone to device dislodgement.

Substrate Characterization and Outcomes of Ventricular Tachycardia Ablation in Amyloid Cardiomyopathy: A Multicenter Study.

Sustained ventricular tachycardia (VT) in cardiac amyloidosis is uncommon, and the substrate and outcomes of catheter ablation are not defined. We included 22 consecutive patients (mean age, 68±10 years; male sex, 91%) with cardiac amyloidosis (ATTR [transthyretin], n=16; light chain, n=6) undergoing catheter ablation for VT/ventricular fibrillation (VF) between 2013 and 2023 in a retrospective, observational, international study. The primary efficacy outcome was recurrent VT/VF during follow-up, while the primary safety end point included major procedure-related adverse events. The indication for ablation was drug-refractory VT in 17 patients (77%), and premature ventricular complex-initiated polymorphic VT/VF in 5 patients (23%). Catheter ablation was performed using endocardial (n=17.77%) or endo-epicardial approaches (n=5.23%). Complete endocardial electroanatomical voltage maps of the left and right ventricles were obtained in 17 (77%) and 10 (45%) patients, respectively. Each patient had evidence of low-voltage areas, most commonly involving the interventricular septum (n=16); late potentials were recorded in 16 patients (73%). A median of 1 (1-2) VT was inducible per patient; 12 of the 26 mappable VTs (46%) originated from the interventricular septum. Complete procedural success was achieved in 16 patients (73%), with 4 (18%) major procedure-related adverse events. After a median follow-up of 32 (14-42) months, sustained VT/VF recurrence was observed in 9 patients (41%); survival free from VT/VF recurrence was 56% (95% CI, 36%-86%) at 36-month follow-up, and most patients remained on antiarrhythmic drugs. A significant reduction in per patient implantable cardioverter defibrillator therapies was noted in the 6-month period after ablation (before: 6 [4-9] versus after: 0 [0-0]; P<0.001). In multivariable analysis, complete procedural success was associated with reduced risk of recurrent VT/VF (hazard ratio, 0.002; P=0.034). Catheter ablation can achieve control of recurrent VT/VF in more than half of patients with cardiac amyloidosis, and the reduction in VT/VF burden post-ablation may be relevant for quality of life. Septal substrate and risk of procedure-related complications challenge successful management of patients with cardiac amyloidosis and VT/VF.

MethOxyfluraNe in InTerventiOnal Radiology (MONITOR): Arandomised controlled trial.

Procedural sedation and pain management in interventional radiology (IR) are of critical importance to successful outcomes but remain under-researched. Methoxyflurane has been previously used in some minor procedures with several advantages including rapid onset and offset and a good safety profile. The purpose of this study was to evaluate methoxyflurane for procedures in IR. A randomised, double-blind, placebo-controlled trial was performed between October 2021 and November 2022. Patients presenting for portacath insertion, portacath removal or solid organ biopsy were randomised to either methoxyflurane or placebo. Three hundred and fourteen patients were enrolled in total. Patients were supplied with one Penthrox inhaler containing either 3 mL methoxyflurane or placebo. The primary endpoints of the study were change in pain and anxiety scores compared with baseline, measured on a standardised visual analogue scale (VAS) pre-procedure, at 5-min intervals during the procedure and post-procedure. Baselines scores were controlled for in the statistical analysis. Safety analysis was also performed. One hundred and sixty-nine patients received methoxyflurane and 145 received placebo. Baseline characteristics were similar between the two groups. The methoxyflurane group had lower pain and anxiety scores throughout the procedure (P < 0.001) with 2.5 times less pain (VAS 1.08/10) and 1.6 times less anxiety (VAS 0.97/10) on average. Lower post-procedure pain (mean 0.72 vs 1.44; P < 0.001) and anxiety (mean 0.55 vs 1.13; P = 0.008) were also observed with methoxyflurane. There were no drug or major procedure-related adverse events. The results of this study suggest that methoxyflurane provides safe and effective analgesia and anxiolysis for some procedures in IR.

Substrate characterization and outcomes of ventricular tachycardia ablation in amyloid cardiomyopathy: a worldwide study

Abstract Background the electrophysiological substrate underpinning ventricular tachycardia (VT) in cardiac amyloidosis (CA) remains elusive, and outcomes of catheter ablation in this peculiar population are currently unknown. Purpose we sought to describe the electrophysiological substrate and clinical outcomes of VT ablation in a cohort of patients with CA. Methods we included 19 consecutive patients (mean age, 69±10 years; male sex, 89%) with CA (ATTR, n=13; AL, n=6) undergoing catheter ablation for VT/ventricular fibrillation (VF) between 2013 and 2023 in a retrospective, observational, international study, involving 7 referral European and North American electrophysiology units. The primary efficacy outcome was recurrent VT/VF during follow-up, while the primary safety outcome included major procedure-related adverse events. Results the indication for ablation was drug-refractory VT in 16 patients (84%), and PVC-initiated polymorphic VT/VF in 3 (16%). Catheter ablation was performed using endocardial (n=14, 74%) or endo-epicardial approaches (n=5, 26%). Complete endocardial electroanatomical voltage maps of the left and right ventricles were obtained in 14 (74%) and 6 (32%) patients, respectively. Each patient had evidence of low-voltage areas, most commonly involving the interventricular septum (n=12); late potentials were recorded in 13 patients (68%). A median of 1 (1-2) VTs were inducible per patient; in 10 subjects (43% of mappable VTs), activation mapping was consistent with septal VT origin. Complete procedural success was obtained in 13 patients (68%), at the expense of 4 (21%) major procedure-related adverse events. After a median follow-up of 36 (18-54) months, sustained VT/VF recurrence was observed in 9 patients (47%); survival free from VT/VF recurrence was 74% (95%CI, 56-96%) at 12 months, and 53% (95%CI, 34-94%) at 36-month follow-up; the majority of patients remained on antiarrhythmic drugs (Figure). Low-voltage QRS (HR,21.96; p=0.022) and complete procedural success (HR,0.08; p=0.029) were associated with recurrent VT/VF at multivariable analysis (Figure). Conclusions catheter ablation of VT/VF is associated with favorable acute and mid-term arrhythmia control, yet with substantial risk of procedure-related complications and long-term recurrences. Septal substrate and frailty challenge successful management of patients with CA and VT/VF.Multimodality evaluation of LV substrateMain Study Outcomes

Acute safety and efficacy of ablation for atrial fibrillation in elderly patients by means of pulsed field ablation

Abstract Background It is well known that age affects the efficacy of pharmacological treatment for atrial fibrillation (AF). Thermal ablation (radiofrequency or cryoballoon) is an established strategy for AF. However, there is no evidence evaluating efficiency, effectiveness, and safety outcomes in elderly patients in the context of the novel pulsed-field ablation (PFA) technology. Purpose We aimed to analyze the efficacy and safety of PFA in elderly (age≥75 years) patients with AF compared to non-elderly (age&amp;lt;75 years) patients with AF. Methods All consecutive patients undergoing AF ablation with the Farapulse system at 10 centers were included. Protocol-directed PVI was delivered using 2000 V with eight applications per vein, that is, four applications each in the basket and flower poses. Additional lesions were performed at the operator’s discretion. Results A total of 851 consecutive patients were included: 83 (9.8%) had ≥75 years (median of 77[75-78] years) whereas 768 (90.2%) had &amp;lt;75 years (median of 62[56-68] years, p&amp;lt;0.0001). Older patients had more comorbidities compared to younger patients (kidney disease: 9.6% vs 1.2%, p&amp;lt;0.0001; chronic obstructive pulmonary disease: 8.4% vs 3%, p=0.021; cancer history: 18.1% vs 6.1%, p=0.0004; hypertension: 61.4% vs 43.8%, p=0.002), whereas they exhibited a higher LVEF (60±6% vs 57±8%, p=0.0243). No differences between older and younger patients were found in terms of underlying AF type (paroxysmal AF: 66.3% vs 68.9%, p=0.62), procedure type (repeat ablation: 8.4% vs 13.4%, p=0.29), more extensive lesion set than PVI only (28.9% vs 22.5%, p=0.22) and the use of 3D mapping system (22.9% vs 21.1%, p=0.67). By looking at procedural metrics, no differences were also found between groups: 73±28 min vs 72±32 min for skin-to-skin time, p=0.41; 93±41 min vs 88±43 min for preparation plus skin-to-skin time, p=0.11; 18±9 min vs 17±9 min for fluoroscopy time, p=0.61 and 32[32-40] vs 32[32-38] PFA spots to achieve PVI, p=0.29. PVI was achieved in all patients. No major procedure-related adverse events were reported. Conclusion In our experience, the use of Farapulse PFA system for AF ablation in elderly patients was rapid, safe and effective, with no differences compared to the younger population.

Pulsed-field ablation of atrial fibrillation in patients with multiple cardiovascular comorbidities: acute safety and efficacy from a large nationwide multicenter experience

Abstract Background Patients with multiple cardiovascular (CV) comorbidities are increasing users of health care globally. The decision to perform ablation of atrial fibrillation (AF) may be challenging in this population, due to the difficulty in evaluating their life expectancy and the associated procedural risk. In addition, no data have been reported on the efficiency, effectiveness, and safety outcomes for non-thermal ablation, such as electroporation with pulsed-field ablation (PFA). Purpose To evaluate procedural workflow and safety for AF ablation in these patients through a novel PFA technology (Farapulse) in a large, nationwide clinical practice. Methods Consecutive patients who had undergone PFA of AF from 10 Italian centers were included. Patients were stratified according to the numbers of several comorbidities, assigning 1 point each, including: advanced age (≥80 years), LVEF≤35%, structural heart disease, coronary artery disease, chronic kidney disease, chronic obstructive pulmonary disease, previous stroke/TIA, hyperthyroidism, cancer history, cancer ongoing, severe sleep apnea, diabetes, hypertension, dyslipidemia. Results We included 634 patients (age 62±9 years, 73% male, 67% paroxysmal AF, 88% de novo ablation procedure, LVEF 57±8%). Two-hundred-nine (33%) patients had no risk-factors, 179 (28.2%) patients had at least 1, 137 (21.6%) two, 63 (9.9%) patients 3 risk-factors and 46 (7.3%) patients more than 4 comorbidities. Patients with accumulated risk factors (≥4) had a higher percentage of long-standing AF (17.4% vs 5.4%, p=0.005) and more often underwent de novo ablation procedure (93.5% vs 81.3%, p=0.04). In these cases, operators decided to adopt more frequently, albeit not significantly, advanced diagnostic such as 3D mapping system (30.4% vs 21.9%, p=0.20) or intracardiac echocardiography (41.3% vs 29.8%, p=0.13), a general anesthesia sedation strategy (41.3% vs 32.1%, p=0.88) and a more extensive lesion set beyond PVI (i.e. left atrial posterior wall area, 32.6% vs 23.1%, p=0.15). Procedures in which patients with accumulated risk factors are involved required longer support (preparation plus skin-to-skin) time (90[65-120] min vs 72[60-100] min, p=0.02) and skin-to-skin time (70[60-100] min vs 60[55-85] min, p=0.03) compared to patients with &amp;lt;4 risk factors, whereas time to PVI (19[14-25] min vs 20[14-25] min, p=0.81) and total number of PFA deliveries to achieve PVI (32[32-38] vs 32[32-36], p=0.55) were similar. PVI was achieved in all patients. No major procedure-related adverse events were reported. Conclusion In this preliminary experience, the use of Farapulse PFA system for AF ablation in patients with accumulated risk factors was safe and effective and resulted in similar and fast time to PVI.

Left atrial posterior wall isolation during catheter ablation with the pulsed field ablation in patients with persistent atrial fibrillation

Abstract Background Few data are available on pulsed-field ablation (PFA) targeting left atrial posterior wall (LAPW) in persistent atrial fibrillation (PeAF) patients. Purpose We sought to explore the role of PFA in persistent AF patients beyond pulmonary vein isolation (PVI), extending the lesion set to obtain LAPW isolation. Methods We enrolled consecutive patients referred for persistent AF catheter ablation using the Farapulse PFA system at nine Italian centers. Complete 3D mapping was performed before and immediately after LAPW isolation to validate our workflow in all cases. To analyze lesions' formation and residual gaps, the line around each pair of PVs was divided into 7 distinct sections in accordance with the literature, while the roof line, the floor line, and the two longitudinal posterior wall lines were equally divided into three parts. The PW was overall divided into nine regions. This scheme has been illustrated in Figure 1, Panel A. Results Fifty patients meeting inclusion criteria were included. PVI was achieved in all 202 (100%) PVs (1 patient exhibited a left common trunk, 2 patients exhibited a right middle cardiac PV). One-hundred ninety-eight (98.0%) PVs were acutely isolated on first pass, as confirmed by both entrance and exit block on subsequent 3D-mapping with the mapping catheter. A total of 7 PV gaps were detected through 3D mapping: 4 at the RSPV, 2 at the RIPV and 1 at the LSPV. When considering LAPWI, overall LAPW ablated area was 20.0±6 cm2 with lesions being deployed with the PFA catheter maneuvered in the flower configuration from one LAPW area to another. First-pass roof area (sectors #1 to #3) block was achieved in 44 (88%), first-pass floor area (sectors #7 to #9) block in 43 (86%) and inner-area (sectors #3 to #6) block in 45 (90%). A total of 23 residual LAPW activity gaps were detected through validation using high-output pacing and 3D mapping. Remapping examples has been reported in Figure 1, panel B-C-D. Evaluation of individual segments of the LAPW via signals’ assessment from the PFA splines demonstrated an accuracy of 94.9% (437 out of 450 sectors), compared to the results of subsequent high-output pacing and 3D mapping. Following PFA consolidation in these areas, LAPW isolation was successfully achieved in all cases (100%) using PFA alone, with no need for radiofrequency touch-ups. No major procedure-related adverse events were reported. Conclusion A structured workflow with the novel Farapulse PFA system allowed for a reliable, safe, and fast LAPW isolation, as confirmed by ultra-high-density 3D mapping.

Impact of pulmonary vein variant anatomy during cryo-ablation in paroxysmal and persistent AF patients: 1-year outcome from a nationwide multicenter clinical setting

Abstract Background Complete electrical pulmonary vein isolation (PVI) by cryo-balloon approach is a well-established ablation strategy of atrial fibrillation (AF). While contrast findings exist regarding the influence of variant pulmonary vein (PV) anatomy on predicting AF recurrence, limited data are currently available specifically for cases involving the POLARx cryoablation system during PVI. Purpose We report the real-world experience of POLARx in the context of de novo AF ablation in a multicenter Italian registry. Methods Consecutive patients undergoing AF ablation from the CHARISMA registry at 10 Italian centres were included. Protocol-directed cryoablation was delivered for 180 sec or 240 sec according to operator’s preference for isolation achieved in ≤60 sec, or 240 sec if isolation occurred &amp;gt;60 sec or when time to isolation was not available. The ablation endpoint was PVI as assessed by entrance and exit block. All patients were followed-up for at least 12 months after the procedure. Results Four-hundred twenty-nine patients were included (n=358, 83.4% paroxysmal AF, n=71, 16.6% persistent AF, mean age 60.7±10 years, 28.3% female, mean LVEF 58±8%). PVI was achieved in all pts using only cryoablation. Twenty-eight (6.6%) patients exhibited an anatomical variant: 17 (4.0%) a common ostium and 11 (2.6%) an adjunctive PV. The mean number of freeze applications per patient was 5.1 (1.2 for LSPV, 1.3 for LIPV, 1.2 for RSPV and 1.3 for RIPV). Over a median of 398[370-461] days of follow-up, 14 (3.2%) patients experienced an early recurrence of AF during the 90-day blanking period. Overall, 63 patients (14.7%) suffered an AF recurrence after the 90-day blanking period (median time to recurrence 342[171-381] days). The proportion of patients exhibiting AF/AT recurrences was higher in the persistent AF group (17 out 71, 23.9%) than in the paroxysmal AF group (46 out 358, 12.8%, p=0.026), with a hazard ratio of 2.02 (95%CI: 1.2 to 3.5, p=0.0137) whereas patients with anatomy variant showed a similar AF/AT recurrence rate (5 out 28, 17.9%) than in the standard anatomy group (58 out of 401, 14.5%) with a hazard ratio of 1.43 (0.6 to 3.6, p=0.441). Four (0.9%) transient phrenic nerve palsy were observed, both with full recovery in the 48-h post procedure; no major procedure-related adverse events were reported. Conclusion In this multicenter study, the cryo-balloon system demonstrated safety and efficacy in treating both paroxysmal and persistent AF patients, yielding a low incidence of AF/AT recurrence during follow-up, regardless of the presence of variant PV anatomy.

One-year follow-up after active aortic aneurysm sac treatment with shape memory polymer devices during endovascular aneurysm repair

ObjectiveTo determine the safety and efficacy of treating abdominal aortic aneurysm (AAA) sacs with polyurethane shape memory polymer (SMP) devices during endovascular aneurysm repair (EVAR), using a technique to fully treat the target lumen after endograft placement (aortic flow volume minus the endograft volume). SMP devices self-expand in the sac to form a porous scaffold that supports thrombosis throughout its structure. MethodsTwo identical prospective, multicenter, single-arm studies were conducted in New Zealand and the Netherlands. The study population was adult candidates for elective EVAR of an infrarenal AAA (diameter of ≥55 mm in men and ≥50 mm in women). Key exclusion criteria were an inability to adequately seal a common iliac artery aneurysm, patent sac feeding vessels of >4 mm, and a target lumen volume of <20 mL or >135 mL. Target lumen volumes were estimated by subtracting endograft volumes from preprocedural imaging-based flow lumen volumes. SMP devices were delivered immediately after endograft deployment via a 6F sheath jailed in a bowed position in the sac. The primary efficacy end point was technical success, defined as filling the actual target lumen volume with fully expanded SMP at the completion of the procedure. Secondary efficacy outcome measures during follow-up were the change in sac volume and diameter, rate of type II endoleak and type I or III endoleaks, and the rate of open repair and related reinterventions, with data collection at 30 days, 6 months, and 1 year (to date). Baseline sac volumes and diameters for change in sac size analyses were determined from 30-day imaging studies. Baseline and follow-up volumes were normalized by subtraction of the endograft volume. ResultsOf 34 patients treated with SMP devices and followed per protocol, 33 patients were evaluable at 1 year. Preprocedural aneurysm volume was 181.4 mL (95% confidence interval [CI], 150.7-212.1 mL) and preprocedural aneurysm diameter was 60.8 mm (95% CI, 57.8-63.9 mm). The target lumen volume was 56.3 mL (95% CI, 46.9-65.8 mL). Technical success was 100% and the ratio of SMP fully expanded volume to estimated target lumen volume was 1.4 ± 0.3. Baseline normalized sac volume and diameter were 140.7 mL (95% CI, 126.6-154.9 mL) and 61.0 mm (95% CI, 59.7-62.3 mm). The adjusted mean percentage change in normalized volume at 1 year was −28.8% (95% CI, −35.3 to −22.3%; P < .001). The adjusted mean change in sac diameter at 1 year was −5.9 mm (95% CI, −7.5 to −4.4 mm; P < .001). At 1 year, 81.8% of patients (95% CI, 64.5%-93.0%) achieved a ≥10% decrease in normalized volume and 57.6% of patients (95% CI, 39.2%-74.5%) achieved a ≥5 mm decrease in diameter. No device- or study procedure-related major adverse events occurred through 1 year after the procedure. ConclusionsTreatment of AAA sacs with SMP devices during EVAR resulted in significant sac volume and diameter regression at 1 year with an acceptable safety profile in this prospective study.

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.

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.

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.

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.

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.

Radiologically Inserted Gastrostomy Tube Placement Guided by the Assessment and Primary Palliative Care Provided by an Amyotrophic Lateral Sclerosis Multidisciplinary Clinic: A Single-Arm Retrospective Clinical Study.

Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease with a median survival of about 3years. An ALS multidisciplinary team can provide primary palliative care and improve outcomes and quality of life for patients. Feeding tube insertion may be considered for patients with significant weight loss, or respiratory insufficiency. While radiologically inserted gastrostomy (RIG) tube placement may be an option, further studies are required to determine its best timing and appropriateness. This study's objectives were to evaluate the feasibility and outcomes of RIG tube placement in ALS patients over a 90-day follow-up period through the assessment and primary palliative care provided by the multidisciplinary team. This retrospective study reviewed the placement of 16 or 18 French RIG-tube without intubation or endoscopy for 36 ALS patients at a single center between April 2019 and December 2021. Measures included ALS Functional Rating Scale-Revised (ALSFRS-R) scores to determine the ALS stage. Demographic, clinical, procedural, and follow-up data were reviewed. Results showed that the RIG tube placement had a low rate of minor adverse events (11%) and no major procedure-related adverse events. The mean ALSFRS-R score at the time of procedure in subjects who died within 90days was lower than of those alive beyond 90days (P = .04). This study found that RIG-tube placement is a safe and effective way to manage dysphagia in ALS patients and highlights the importance of educating members of the multidisciplinary clinic in palliative care principles to determine the appropriateness of RIG tube placement.

Novel pulsed-field ablation technology for pulmonary vein isolation in patients with atrial fibrillation: preliminary experience from a large multicenter clinical practice

Abstract Funding Acknowledgements Type of funding sources: None. Background Complete electrical pulmonary vein isolation (PVI) by thermal energy sources is a well-established ablation strategy of atrial fibrillation (AF). Recently, a non-thermal ablation approach by means of irreversible cellular electroporation has been made available for clinical use. Purpose We report the preliminary experience of a new pulsed-field ablation (PFA) system in the context of AF ablation in a multicenter Italian setting. Methods All consecutive patients (pts) undergoing AF ablation with PFA at 7 Italian centres were included. Protocol-directed PVI was delivered using 2000 V with eight applications per vein, that is, four applications each in the basket and flower poses. Applications were delivered in pairs at any given catheter position, rotating by ≈30–40° after the first two applications in each configuration. Additional lesions were performed at the operator’s discretion. The ablation endpoint was PVI as assessed by entrance and exit block. Data are reported as median [IQ range]. Results With a median of 32[25-38] pts treated per center, a total of 205 cases were included (n=150 73.2%, paroxysmal AF, n=55, 26.9% persistent AF). Of them 187 (91.2%) were de novo cases, whereas 18 (8.8%) were redo cases. A mapping system was used in 55 (21.5%) procedures and an intracardiac echocardiography in 65 (31.7%) cases. The number of PFA applications to reach PVI was 32[32-36]. Procedural parameters were: fluoroscopy time = 16[12-22] min, skin-to-skin time = 60[55-85] min, support time (preparation plus skin-to-skin) =75[64-95] min, lab occupancy time was 97[75-120] min and PFA LA dwell time was 23[20-28] min. The first pass isolation (FPI) rate per vein was 99.6% resulting from 202 patients (98.5%) with FPI. At the end of the procedure, PVI was achieved in all pts (100%) using only PFA. Additional PFA delivery outside PVs was performed in 19% (n=39) of the cases, mostly at the posterior wall area only (n=34, 87%), requiring 16[12-24] PFA deliveries. All the additional lesion sets were validated through differential pacing and/or 3D mapping. The learning curve was extremely fast. After only 5 cases time to PVI and total support time have significantly improved, whereas we did not notice any additional improvement after 10 or 20 cases (LA dwell time: 27[22-32] min during the first 5 cases vs 23[19-27] min after the first 5 cases, p=0.0172; support time: 100[65-120] min vs 75[65-90] min, p=0.0181, respectively). In 13 (6.3%) cases a transient bradycardia or asystole occurred after the first PFA application requiring temporary high-output pacing. No major procedure-related adverse events were reported. Conclusion In this first multicentric experience, the novel PFA system proved to be safe and effective in both paroxysmal and persistent AF patients. The learning curve seems to be very fast according with procedural parameters.

Sedation strategies for pulsed-field ablation of atrial fibrillation with monitored anesthesia care versus general anesthesia: a single-center experience

Abstract Funding Acknowledgements Type of funding sources: None. Background Atrial Fibrillation (AF) ablation has been performed successfully under different methods of anesthesia and varies between centers, from general anaesthesia (GA) to conscious sedation. Recently, a novel pulsed-field ablation (PFA, Farapulse) technology based on non-thermal ablation has become available for clinical use. To date, no structured sedation strategy has been implemented for this specific energy source. Purpose We sought to compare a GA protocol and a monitored anesthesia care (MAC) protocol used at a high-volume center, with special consideration on efficiency and optimization of mapping and ablation conditions. Methods All consecutive patients (pts) undergoing AF ablation with PFA at our center were included. Briefly, PFA was delivered by a protocol-directed PVI using 2kV with eight applications per vein, that is, four applications each in the basket and flower poses. The choice of anesthesia’s protocol depends on the preference and experience of operator and general conditions of the patient. The MAC protocol includes propofol as only anesthetic agent and analgesia with fentanyl. The GA protocol include propofol and sevofluorane as anesthetic agents and fentanyl and remifentanyl for analgesia. Anesthesia related complications (hypotension and hemodinamic instability, respiratory complications, postoperative nausea and vomit) operative pain, chest movements, operator and patient satisfaction have been reported. Data are reported as mean±DS. Results Thirty-six pts were included in this analysis, 28 (78%) indicated for ablation of paroxysmal AF and 8 (22%) of persistent AF. MAC protocol was applied in 16 (44%) procedures and GA protocol in 30 (56%) procedures. No differences were found in terms of procedural and management parameters according with these two strategies, that is MAC vs GA: 114±28min vs 121±19min for lab occupancy time, p=0.3521; 66±14min vs 81±25min for total support time, p=0.0683; 63±9min vs 63±18min for skin-to-skin time, p=0.3887; and 19±6min vs 20±5min for fluoroscopy time, p=0.3313, respectively). No major procedure-related adverse events were reported. Operative pain and chest movements were less in GA protocol, operator satisfaction was greater in GA protocol. No significant differences in post-operative nausea and vomit and patient satisfaction were found. Conclusion The adoption of a structured workflow with proper perioperative assessment during pulsed-field ablation of AF, both general anesthesia and monitored anesthesia care showed similar efficacy and safety profile.

Cardiac Troponin I kinetic after pulmonary vein isolation for atrial fibrillation ablation with pulsed-field ablation and cryo-energy

Abstract Funding Acknowledgements Type of funding sources: None. Background Previous studies have demonstrated that cardiac biomarkers elevate after both cryoballoon (CB) and radiofrequency atrial fibrillation (AF) ablation, depending on the amount of energy delivered and the site of ablation. To date no comparison has been made between these thermal energy source and a novel non-thermal pulsed-field ablation (PFA) technology based on cells electroporation. Purpose Our analysis aims to compare acute myocardial injury through cardiac troponin I variation after pulmonary vein isolation (PVI) performed with different technologies (PFA vs CB). Methods All consecutive patients undergoing paroxysmal AF ablation with CB and PFA at our center from July to November 2022 were included. Protocol-directed cryoablation (CBA) was delivered for 180 sec or 240 sec according to operator’s preference for isolation achieved in ≤60 sec, or 240 sec if isolation occurred &amp;gt;60 sec or when time to isolation was not available. A standard PFA protocol-directed PVI was applied using 2kV with eight applications per vein (four applications each in the basket and flower poses). The ablation endpoint was PVI as assessed by entrance and exit block. Pre- and post-procedure samples of cardiac troponin I (CTpI) were collected before CBA/PFA and at 24h after ablation. Only patients with normal baseline values for myocardial injury were included. Results A total of 71 patients met inclusion criteria and were included in this analysis. The CBA group consists of 50 (70%) patients and the PFA group comprises 21 (30%) patients. The number of CBA applications to reach PVI was 5.0±1.4 and the number of PFA applications to achieve PVI was 32±4. All (100%) patients were in sinus rhythm at the time of the procedure. Evaluating the kinetic of CTpI, baseline values were homogeneous between CBA and PFA groups (p=0.979) whereas CTpI values significantly rose from baseline (7±2 ng/L) to 24h (8979±3691 ng/L, p&amp;lt;0.0001) and were significantly different between groups after CBA/PFA (8148±3311 ng/L for CBA vs 11900±7143 ng/L for PFA, p=0.0056). PVI was achieved in all patients (100%) using only CB or PFA. No major procedure-related adverse events were reported. Conclusion Our preliminary results showed that cardiac troponin I enzyme level increased after PVI by means of both cryoballoon and pulsed-field ablation and were higher after cellular electroporation by PFA than cryoablation.