Safety of pulsed field ablation in more than 17,000 patients with atrial fibrillation in the MANIFEST-17K study.

Pulsed field ablation (PFA) is an emerging technology for the treatment of atrial fibrillation (AF), for which pre-clinical and early-stage clinical data are suggestive of some degree of preferentiality to myocardial tissue ablation without damage to adjacent structures. Here in the MANIFEST-17K study we assessed the safety of PFA by studying the post-approval use of this treatment modality. Of the 116 centers performing post-approval PFA with a pentaspline catheter, data were received from 106 centers (91.4% participation) regarding 17,642 patients undergoing PFA (mean age 64, 34.7% female, 57.8% paroxysmal AF and 35.2% persistent AF). No esophageal complications, pulmonary vein stenosis or persistent phrenic palsy was reported (transient palsy was reported in 0.06% of patients; 11 of 17,642). Major complications, reported for ~1% of patients (173 of 17,642), were pericardial tamponade (0.36%; 63 of 17,642) and vascular events (0.30%; 53 of 17,642). Stroke was rare (0.12%; 22 of 17,642) and death was even rarer (0.03%; 5 of 17,642). Unexpected complications of PFA were coronary arterial spasm in 0.14% of patients (25 of 17,642) and hemolysis-related acute renal failure necessitating hemodialysis in 0.03% of patients (5 of 17,642). Taken together, these data indicate that PFA demonstrates a favorable safety profile by avoiding much of the collateral damage seen with conventional thermal ablation. PFA has the potential to be transformative for the management of patients with AF.

Echocardiographic assessment of left atrial mechanics in women with hypertensive disorders of pregnancy: A systematic review and meta-analysis.

OBJECTIVE: The influence of hypertensive disorders of pregnancy (HDP) on left atrial (LA) mechanics assessed by speckle tracking echocardiography (STE) has been poorly investigated. Accordingly, we performed a meta-analysis to summarize the main findings of STE studies who measured LA reservoir (LASr), conduit (LAScd) and contractile (LASct) strain in HDP women. STUDY DESIGN: All echocardiographic studies assessing LA strain parameters in HDP women vs. healthy controls, selected from PubMed and EMBASE databases, were included. The risk of bias was assessed by using the National Institutes of Health (NIH) Quality Assessment of Case-Control Studies. Continuous data (LASr, LAScd and LASct) were pooled as standardized mean difference (SMD) comparing HDP group with healthy controls. The overall SMDs of LASr, LAScd and LASct were calculated using the random-effect model. RESULTS: The full-texts of 8 studies with 566 HDP women and 420 healthy pregnant women were analyzed. Average LASr (34.3 ± 6.4 vs 42.7 ± 5.3 %, P = 0.01) and LAScd (23.4 ± 6.3 vs 32.5 ± 6.0 %, P < 0.001) were significantly lower in HDP women than controls, whereas LASct (-13.0 ± 5.4 vs -13.7 ± 4.5 %, P = 0.18) was similar in the two groups of women. Substantial heterogeneity was detected among the studies evaluating LASr (I2 = 94.3 %), LAScd (I2 = 64.9 %) and LASct (I2 = 86.4 %). SMDs were large and statistically significant for LASr (-1.70, 95 %CI -2.34,-1.06, P < 0.001) and LAScd (-1.35, 95 %CI -1.69,-1.00, P < 0.001), small and not statistically significant for LASct (-0.11, 95 %CI -0.60,0.39, P = 0.678) assessment. Egger's test gave P-values of 0.10, 0.34 and 0.75 for LASr, LAScd and LASct measurement respectively, indicating no publication bias. On meta-regression analysis, none of the moderators was significantly associated with effect modification for LASr and its components (all P < 0.05). CONCLUSIONS: HDPs are independently associated with LASr impairment in pregnancy. STE allows to identify, among HDP women, those who might benefit from a more aggressive antihypertensive treatment and/or a closer clinical follow-up, aimed at reducing the risk of adverse maternal outcome and cardiovascular complications later in life.

Functional substrate analysis in patients with persistent atrial fibrillation.

OBJECTIVES: The aim of this study was to describe the correlation between atrial electrogram duration map (AEDUM), spatiotemporal electrogram dispersion (STED) and low voltage areas (LVA) in patients with persistent atrial fibrillation (PsAF). BACKGROUND: The degree of left atrial (LA) tissue remodelling and augmented anisotropic conduction is one of the major issues related to PsAF ablation outcome. METHODS: This study enrolled consecutive patients with PsAF undergoing pulmonary vein isolation. In all patients, voltage, AEDUM and STED maps were created, and the correlation was reported between these three mapping methods. RESULTS: A total of 40 patients with PsAF were enrolled. The mean age was 62.2 ± 7.4 years, and males were 72.5% (n = 29). The overall bipolar voltage of the LA was 3.06 ± 1.87 mV. All patients had at least one AEDUM area (overall AEDUM area: 21.8 ± 8.2 cm2); the mean longest electrogram (EGMs) duration was 90 ± 19 ms. STED areas with < 120 ms was 46.3 ± 20.2 cm2 which covered 45 ± 22% of the LA surface. AEDUM and STED areas were most frequently reported on the roof, the anterior wall and the septum. The extension of the AEDUM areas was significantly smaller than STED areas with CL < 120 ms (21.8 ± 8.2 vs 46.3 ± 20.2; p-value < 0.0001). In 24 patients (60%), AEDUM areas was entirely included in the STED areas with CL < 120 ms. In the three (7.5%) patients with LVA, no correspondence with STED and AEDUM was noted. CONCLUSION: AEDUM and STED maps allow to identify areas of conductive dysfunction as a possible atrial substrate even if a normal voltage is detected.

National workflow experience with pulsed field ablation for atrial fibrillation: learning curve, efficiency, and safety.

BACKGROUND: Recent data on pulsed field ablation (PFA) for atrial fibrillation (AF) ablation suggest a progressive reduction in procedural times. Real-world data regarding the relationship between the learning curve of PFA and clinical outcomes are scarce. The objective was to evaluate the PFA learning curve and its impact on acute outcomes. METHODS: Consecutive patients undergoing AF ablation with the FARAPULSE™ PFA system were included in a prospective, non-randomized multicenter study. Procedural times were stratified on the operators' learning curve. Comparative analysis of skin-to-skin time was conducted with radiofrequency (RF) and cryoablation (CB) pulmonary vein isolation (PVI) procedures performed by the same operators in the previous year. RESULTS: Among 752 patients, 35.1% were females, and 66.9% had paroxysmal AF; mean age was 62.2 ± 10 years. A total of 62.5% of procedures were performed by operators with > 20 PFA procedures. Both time to PVI (25.6 ± 10 min vs 16.5 ± 8, p < 0.0001) and fluoroscopy time (19.8 ± 8 min vs 15.9 ± 8 min, p = 0.0045) significantly improved after 10 associated with consistent linear trend towards procedural time reduction (R2 0.92-0.68 across various procedural metrics). Current PFA skin-to-skin time was lower than the historical skin-to-skin one in 217 (62.4%) procedures; it was similar in 112 (32.2%) cases and higher than the historical skin-to-skin one in 19 (5.5%). No major complications were reported. CONCLUSIONS: In this nationwide multicentric experience, the novel PFA system proved to be fast, safe, and acutely effective in both paroxysmal and persistent AF patients. The learning curve appears to be rapid, as improvements in procedural parameters were observed after only a few procedures. CLINICAL TRIAL REGISTRATION: Advanced TecHnologies For SuccEssful AblatioN of AF in Clinical Practice (ATHENA). URL: http://clinicaltrials.gov/ Identifier: NCT05617456.

Sonographic diagnosis of radiographically undetectable bennet fracture.

Intra-articular fractures of the base of the first metacarpal (Bennet fractures) are prone to dislocation and require surgical reduction and fixation to prevent secondary degenerative joint disease and chronic dysfunction. Therefore, a prompt diagnosis is necessary, mostly achieved by conventional roentgenograms. We report the case of a 62-year-old man in whom a Bennet fracture was highly suspected on ultrasound (US) examination realized after a fall. Standard radiographs, obtained after US to confirm the diagnosis, were interpreted as normal. A computed tomography was then performed showing a typical Bennet fracture. This case report demonstrates that a careful assessment of bones must be an integral part of any routine musculo-skeletal US examination, particularly in post-traumatic patients. US can detect bone fractures where radiograph is not discriminating.

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

INTRODUCTION: Limited data exist on pulsed-field ablation (PFA) in patients with persistent atrial fibrillation (PeAF) undergoing left atrial posterior wall isolation (LAPWI). METHODS: 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. RESULTS: 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. CONCLUSION: 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.

Sarcopenia diagnosed by ultrasound-assessed quadriceps muscle thickness and handgrip strength predicts mortality in patients on hemodialysis.

BACKGROUND: Estimation of muscle mass is a pivotal component in the diagnosis of protein-energy wasting and sarcopenia. While bioimpedance spectroscopy is a widely  accepted technique for the assessment of lean tissue related to the diagnosis of sarcopenia, to date skeletal muscle ultrasound (US) has not gained full acceptance for this purpose. The aim of this study was to assess the predictive value for mortality of the indexed thickness of the quadriceps vastus intermedius, as measured by US, compared to lean tissue index as estimated by bioimpedance spectroscopy, both combined with handgrip strength in a group of patients with end-stage kidney disease (ESKD) on maintenance hemodialysis (HD). METHODS: The cut-off values for low handgrip strength were < 27 kg for males and < 16 kg for females. The cut-off value for low lean tissue index was obtained from an age-matched healthy control group, with low lean tissue index being defined as values below the 10th percentile of the distribution of healthy subjects. The cut-off values for low quadriceps vastus intermedius thickness index were < 3.44 mm/m2 for males and < 3.52 mm/m2 for females. RESULTS: Ultrasound and bioimpedance spectroscopy were performed in 99 patients, and handgrip strength was assessed in 64 patients, all on maintenance HD. After a median follow-up of 28 months (interquartile range 19-41 months) 38 patients died. Lean tissue index was not associated with mortality, while low quadriceps vastus intermedius thickness index and low handgrip strength were associated with an increased hazard of death. In the fully adjusted model, only the combination of low handgrip strength and low quadriceps vastus intermedius thickness index was significantly associated with higher mortality. CONCLUSION: When combined with low handgrip strength, low quadriceps muscle US outperformed low lean tissue index as assessed by bioimpedance spectroscopy in predicting mortality in a cohort of patients on maintenance HD. Ultrasound may be a useful and convenient technique for the assessment of sarcopenia and protein-energy wasting in this patient population.

Practical guide on left atrial appendage closure for the non-implanting physician: an international consensus paper.

A significant proportion of patients who suffer from atrial fibrillation (AF) and are in need of thromboembolic protection are not treated with oral anticoagulation or discontinue this treatment shortly after its initiation. This undertreatment has not improved sufficiently despite the availability of direct oral anticoagulants which are associated with less major bleeding than vitamin K antagonists. Multiple reasons account for this, including bleeding events or ischaemic strokes whilst on anticoagulation, a serious risk of bleeding events, poor treatment compliance despite best educational attempts, or aversion to drug therapy. An alternative interventional therapy, which is not associated with long-term bleeding and is as effective as vitamin K anticoagulation, was introduced over 20 years ago. Because of significant improvements in procedural safety over the years, left atrial appendage closure, predominantly achieved using a catheter-based, device implantation approach, is increasingly favoured for the prevention of thromboembolic events in patients who cannot achieve effective anticoagulation. This management strategy is well known to the interventional cardiologist/electrophysiologist but is not more widely appreciated within cardiology or internal medicine. This article introduces the devices and briefly explains the implantation technique. The indications and device follow-up are more comprehensively described. Almost all physicians who care for adult patients will have many with AF. This practical guide, written within guideline/guidance boundaries, is aimed at those non-implanting physicians who may need to refer patients for consideration of this new therapy, which is becoming increasingly popular.

Lower rate of major bleeding in very high risk patients undergoing left atrial appendage occlusion: A propensity score-matched comparison with direct oral anticoagulant.

BACKGROUND: Long-term oral anticoagulation is the mainstay therapy for thromboembolic (TE) prevention in patients with atrial fibrillation. However, left atrial appendage occlusion (LAAO) could be a safe alternative to direct oral anticoagulants (DOACs) in patients with a very high TE risk profile. OBJECTIVE: The purpose of this study was to compare the safety and efficacy of LAAO vs DOACs in patients with atrial fibrillation at very high stroke risk (CHA2DS2-VASc [congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischemic attack or thromboembolism, vascular disease, age 65-74 years, sex category] score ≥ 5). METHODS: Data from patients with CHA2DS2-VASc score ≥ 5 were extracted from a prospective multicenter database. To attenuate the imbalance in covariates between groups, propensity score matching was used (covariates: CHA2DS2-VASc and HAS-BLED [hypertension, abnormal renal or liver function, stroke, bleeding, labile international normalized ratio, elderly, drugs or alcohol] scores), which resulted in a matched population of 277 patients per group. The primary end point was a composite of cardiovascular death, TE events, and clinically relevant bleeding during follow-up. RESULTS: Of 2381 patients, 554 very high risk patients were included in the study (mean age 79 ± 7 years; CHA2DS2-VASc score 5.8 ± 0.9; HAS-BLED score 3.0 ± 0.9). The mean follow-up duration was 25 ± 11 months. A higher incidence of the composite end point was documented with DOACs compared with LAAO (14.9 events per 100 patient-years in the DOAC group vs 9.4 events per 100 patient-years in the LAAO group; P = .03). The annualized clinically relevant bleeding risk was higher with DOACs (6.3% vs 3.2%; P = .04), while the risk of TE events was not different between groups (4.1% vs 3.2%; P = .63). CONCLUSION: In high-risk patients, LAAO had a similar stroke prevention efficacy but a significantly lower risk of clinically relevant bleeding when compared with DOACs. The clinical benefit of LAAO became significant after 18 months of follow-up.

Ablation of persistent atrial fibrillation based on atrial electrogram duration map: methodology and clinical outcomes from the AEDUM pilot study.

BACKGROUND: Catheter ablation of persistent atrial fibrillation (PsAF) represents a challenge for the electrophysiologist and there are still divergences regarding the best ablative approach to adopt. Create a new map of the duration of atrial bipolar electrograms (Atrial Electrogram DUration Map, AEDUM) to recognize a functional substrate during sinus rhythm and guide a patient-tailored ablative strategy for PsAF. METHODS: Forty PsAF subjects were assigned in a 1:1 ratio to either for PVI alone (Group B1) or PVI+AEDUM areas ablation (Group B2). A cohort of 15 patients without AF history undergoing left-sided accessory pathway ablation was used as a control group (Group A). In all patients, voltage and AEDUM maps were created during sinus rhythm. The minimum follow-up was 12 months, with rhythm monitoring via 48-h ECG Holter or by implantable cardiac device. RESULTS: Electrogram (EGM) duration was higher in Group B than in Group A (49±16.2ms vs 34.2±3.8ms; p-value<0.001). In Group B the mean cumulative AEDUM area was 21.8±8.2cm2; no difference between the two subgroups was observed (22.3±9.1cm2 vs 21.2±7.2cm2; p-value=0.45). The overall bipolar voltage recorded inside the AEDUM areas was lower than in the remaining atrial areas [median: 1.30mV (IQR: 0.71-2.38mV) vs 1.54mV (IQR: 0.79-2.97mV); p-value: <0.001)]. Low voltage areas (<0.5mV) were recorded in three (7.5%) patients in Group B. During the follow-up [median 511 days (376-845days)] patients who underwent PVI-only experienced more AF recurrence than those receiving a tailored approach (65% vs 35%; p-value= 0.04). CONCLUSIONS: All PsAF patients exhibited AEDUM areas. An ablation approach targeting these areas resulted in a more effective strategy compared with PVI only.

Real-world usage of Chronic Kidney Disease - Mineral Bone Disorder (CKD-MBD) biomarkers in nephrology practices.

Background: Chronic kidney disease mineral bone disorder (CKD-MBD) is a condition characterized by alterations of calcium, phosphate, parathyroid hormone (PTH), and fibroblast growth factor 23 (FGF-23) metabolism that in turn promote bone disorders, vascular calcifications, and increase cardiovascular (CV) risk. Nephrologists' awareness of diagnostic, prognostic, and therapeutic tools to manage CKD-MBD plays a primary role in adequately preventing and managing this condition in clinical practice. Methods: A national survey (composed of 15 closed questions) was launched to inquire about the use of bone biomarkers in the management of CKD-MBD patients by nephrologists and to gain knowledge about the implementation of guideline recommendations in clinical practice. Results: One hundred and six Italian nephrologists participated in the survey for an overall response rate of about 10%. Nephrologists indicated that the laboratories of their hospitals were able to satisfy request of ionized calcium levels, 105 (99.1%) of both PTH and alkaline phosphatase (ALP), 100 (94.3%) of 25(OH)D, and 61 (57.5%) of 1.25(OH)2D; while most laboratories did not support the requests of biomarkers such as FGF-23 (intact: 88.7% and c-terminal: 93.4%), Klotho (95.3%; soluble form: 97.2%), tartrate-resistant acid phosphatase 5b (TRAP-5b) (92.5%), C-terminal telopeptide (CTX) (71.7%), and pro-collagen type 1 N-terminal pro-peptide (P1NP) (88.7%). As interesting data regarding Italian nephrologists' behavior to start treatment of secondary hyperparathyroidism (sHPT), the majority of clinicians used KDOQI guidelines (n = 55, 51.9%). In contrast, only 40 nephrologists (37.7%) relied on KDIGO guidelines, which recommended referring to values of PTH between two and nine times the upper limit of the normal range. Conclusion: Results point out a marked heterogeneity in the management of CKD-MBD by clinicians as well as a suboptimal implementation of guidelines in Italian clinical practice.

The effect of gestational diabetes mellitus on carotid artery intima-media thickness in and after pregnancy: a systematic review and meta-analysis.

AIMS: The association between gestational diabetes mellitus (GDM) and common carotid artery (CCA) intima-media thickness (IMT) is still controversial. This systematic review and meta-analysis was performed to assess the correlation between GDM and CCA-IMT in and after pregnancy. METHODS: PubMed and EMBASE databases were systematically reviewed on April 2023. Studies measuring CCA-IMT in both pregnant women with GDM and women with previous history of GDM (pGDM) vs. healthy controls were included. The subtotal and overall standardized mean differences (SMDs) of CCA-IMT were calculated using the random-effect model. RESULTS: Nineteen studies with a total of 302 GDM and 861 pGDM women were analyzed. The average value of CCA-IMT measured in GDM/pGDM (0.59 ± 0.12 mm) was slightly increased in comparison to the accepted reference limits of IMT according to age classes. Substantial heterogeneity was detected for the studies involving both GDM and pGDM women, with an overall statistic I2 of 86.0% (p < 0.001). Large SMDs were obtained for the studies conducted on both GDM and pGDM women, with an overall SMD of 0.89 (95%CI 0.63-1.15, p < 0.001). Egger's test for a regression intercept gave a p-value of 0.37, indicating no publication bias. On meta-regression analysis, all potential confounders (number of patients, age at pregnancy, body mass index, measuring time, follow-up duration and GDM criteria) were not significantly associated with effect modification. CONCLUSIONS: GDM in and after pregnancy is independently associated with subclinical atherosclerosis. The association between GDM and carotid remodeling is potentially mediated by the longstanding underlying risk.

Influence of gestational diabetes mellitus on subclinical myocardial dysfunction during pregnancy: A systematic review and meta-analysis.

OBJECTIVE: The correlation between gestational diabetes mellitus (GDM) and subclinical myocardial dysfunction has been poorly investigated. Accordingly, we performed a meta-analysis to examine the influence of GDM on left ventricular (LV) global longitudinal strain (GLS), assessed by speckle tracking echocardiography (STE), during pregnancy. STUDY DESIGN: All echocardiographic studies assessing conventional echoDoppler parameters and LV-GLS in GDM women vs. healthy controls, selected from PubMed and EMBASE databases, were included. The risk of bias was assessed by using the National Institutes of Health (NIH) Quality Assessment of Case-Control Studies. The subtotal and overall standardized mean differences (SMDs) of LV-GLS were calculated using the random-effect model. RESULTS: The full-texts of 10 studies with 1147 women with GDM and 7706 pregnant women without diabetes were analyzed. GDM women enrolled in the included studies were diagnosed with a small reduction in LV-GLS in comparison to controls (average value -19.4 ± 2.5 vs -21.8 ± 2.5 %, P < 0.001) and to the accepted reference values (more negative than -20 %). Substantial heterogeneity was detected for the included studies, with an overall statistic value I2 of 94.4 % (P < 0.001). Large SMDs were obtained for the included studies, with an overall SMD of -0.97 (95 %CI -1.32, -0.63, P < 0.001). Egger's test for a regression intercept gave a P-value of 0.99, indicating no publication bias. On meta-regression analysis, all moderators and/or potential confounders (age at pregnancy, BMI, systolic blood pressure and ethnicity) were not significantly associated with effect modification (all P < 0.05). CONCLUSIONS: GDM is independently associated with subclinical myocardial dysfunction in pregnancy. STE analysis allows to identify, among GDM women, those who might benefit of targeted non-pharmacological and/or pharmacological interventions, aimed at reducing the risk of developing type 2 diabetes and cardiovascular complications later in life.

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

BACKGROUND: Modified cardiac sympathetic denervation (CSD) with stellate ganglion (SG) sparing is a novel technique for cardiac neuromodulation in patients with refractory ventricular tachycardia (VT). OBJECTIVES: 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. METHODS: 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. RESULTS: We enrolled 15 patients (age: 69.2 ± 7.9 years; 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 ± 2.4 min per side; no major periprocedural complication occurred. After a median follow-up time of 15 months (IQR: 8.5-24.5 months), 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 < 340 ms were associated with better outcomes. CONCLUSIONS: 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.

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

BACKGROUND: 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. PURPOSE: We aimed to assess whether the use of ICE could improve procedural parameters in a large population undergoing AF ablation with FARAPULSE™ catheter. METHODS: 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. RESULTS: 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 ± 6 min vs 18.5 ± 9 min 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 ± 19 min vs 71.8 ± 29 min for primary operator time, p = 0.5301; 16.1 ± 8 min vs 18.2 ± 10 min for fluoroscopy time, p = 0.5476) except for support time (76.8 ± 26 min vs 91.4 ± 37 min, p = 0.0046). No major procedure-related adverse events were reported. CONCLUSION: 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.

Pulmonary vein isolation by means of a novel cryoballoon technology in paroxysmal atrial fibrillation patients: 1-year outcome from a large Italian multicenter clinical registry.

INTRODUCTION: Recently, a new cryoballoon (CB) technology (POLARx; Boston Scientific) has come onto the market. Preliminary data have shown that its acute safety and efficacy are similar to those of the first-generation CB. The aim of this study was to assess the medium-term outcome of pulmonary vein isolation (PVI) with the POLARxTM CB in a large multicenter registry. METHODS: We prospectively collected data on 125 consecutive patients with paroxysmal atrial fibrillation (AF) who underwent PVI by means of a novel CB system. Two cases of transient phrenic nerve palsy occurred, with full recovery in the 48h post procedure; no major procedure-related adverse events were reported. During the 90-day blanking period, 4 (3.2%) patients experienced an early recurrence. After the blanking period, over a mean follow-up of 411 ± 62 days, 19 patients (15.2%) suffered an AF/atrial tachycardia (AT) recurrence. The 1-year freedom from AF/AT recurrence was 86.4% (n = 17): 10 (8%) patients had an AF recurrence, 6 (4.8%) had an AT occurrence and 1 (0.8%) suffered both events. Patients with AF/AT recurrences had both a shorter deflation time and total deflation time. Moreover, CB ablations with measured TTI < 90 s and TTI < 60 s were more frequent in patients without AF/AT recurrence (88.5% and 77.4%, respectively) than in those who experienced at least one AF/AT recurrence (67.5% and 55.0%, p = .001 and p = .005, respectively). CONCLUSION: The novel POLARx cryo-balloon system is safe and effective for PV isolation, displaying a 1-year freedom from atrial arrhythmia recurrence of 86.4%, which is in line to that reported with AFA-Pro CB or RF ablation. CLINICAL TRIAL REGISTRATION: Catheter Ablation of Arrhythmias with a High-Density Mapping System in Real-World Practice (CHARISMA). URL: http://clinicaltrials.gov/ Identifier: NCT03793998. Registration date: January 4, 2019.

Bridging the gap in the symptomatic heart failure patient journey: insights from the Italian scenario.

BACKGROUND: The prognosis for heart failure (HF) patients remains poor, with a high mortality rate, and a marked reduction in quality of life (QOL) and functional status. This study aims to explore the ongoing needs of HF management and the epidemiology of patients followed by Italian HF clinics, with a specific focus on cardiac contractility modulation (CCM). RESEARCH DESIGN AND METHODS: Data from patients admitted to 14 HF outpatients clinics over 4 weeks were collected and compared to the results of a survey open to physicians involved in HF management operating in Italian centers. RESULTS: One hundred and five physicians took part in the survey. Despite 94% of patients receive a regular follow-up every 3-6 months, available therapies are considered insufficient in 30% of cases. Physicians reported a lack of treatment options for 23% of symptomatic patients with reduced ejection fraction (EF) and for 66% of those without reduced EF. Approximately 3% of HF population (two patients per month per HF clinic) meets the criteria for immediate CCM treatment, which is considered a useful option by 15% of survey respondents. CONCLUSIONS: Despite this relatively small percentage, considering total HF population, CCM could potentially benefit numerous HF patients, particularly the elderly, by reducing hospitalizations, improving functional capacity and QOL.