Fertility specialists' views, behavior, and attitudes towards the use of endometrial scratching in Italy.

BACKGROUND: Endometrial scratching (ES) or injury is intentional damage to the endometrium performed to improve reproductive outcomes for infertile women desiring pregnancy. Moreover, recent systematic reviews with meta-analyses and randomized controlled trials demonstrated that ES is not effective, data on the safety are limited, and it should not be recommended in clinical practice. The aim of the current study was to assess the view and behavior towards ES among fertility specialists throughout infertility centers in Italy, and the relationship between these views and the attitudes towards the use of ES as an add-on in their commercial setting. METHODS: Online survey among infertility centers, affiliated to Italian Society of Human Reproduction (SIRU), was performed using a detailed questionnaire including 45 questions with the possibility to give "closed" multi-choice answers for 41 items and "open" answers for 4 items. Online data from the websites of the infertility centers resulting in affiliation with the specialists were also recorded and analyzed. The quality of information about ES given on infertility centers websites was assessed using a scoring matrix including 10 specific questions (scored from 0 to 2 points), and the possible scores ranged from 0 to 13 points ('excellent' if the score was 9 points or more, 'moderate' if the score was between 5 and 8, and 'poor' if it was 4 points or less). RESULTS: The response rate was of 60.6% (43 questionnaires / 71 infertility SIRU-affiliated centers). All included questionnaires were completed in their entirety. Most physicians (~ 70%) reported to offer ES to less than 10% of their patients. The procedure is mainly performed in the secretory phase (69.2%) using pipelle (61.5%), and usually in medical ambulatory (56.4%) before IVF cycles to improve implantation (71.8%) without drugs administration (e.g., pain drugs, antibiotics, anti-hemorrhagics, or others) before (76.8%) or after (64.1%) the procedure. Only a little proportion of infertility centers included in the analysis proposes formally the ES as an add-on procedure (9.3%), even if, when proposed, the full description of the indications, efficacy, safety, and costs is never addressed. However, the overall information quality of the websites was generally "poor" ranging from 3 to 8 and having a low total score (4.7 ± 1.6; mean ± standard deviation). CONCLUSIONS: In Italy, ES is a procedure still performed among fertility specialists for improving the implantation rate in IVF patients. Moreover, they have a poor attitude in proposing ES as an add-on in the commercial setting.

A randomized controlled trial of cardiac resynchronization therapy in patients with prolonged atrioventricular interval: the REAL-CRT pilot study.

AIMS: A prolonged PR interval is known to be associated with increased mortality and a higher risk of developing atrial fibrillation (AF). We tested the hypothesis that cardiac resynchronization therapy (CRT) is superior to conventional dual-chamber pacing with algorithms for right ventricular pacing avoidance (DDD-VPA) in preserving systolic and diastolic function and in preventing new-onset AF in patients with normal systolic function, indication for pacing and prolonged atrioventricular conduction (PR interval ≥220 ms). METHODS AND RESULTS: We randomly assigned 82 patients with ejection fraction >35%, indication for pacing and PR interval ≥220 ms to CRT or to DDD-VPA. On 12-month follow-up examination, the study and control arms did not differ in terms of left ventricular end-systolic volume (44 ± 17 mL vs. 47 ± 16 mL, P = 0.511) or ejection fraction (55 ± 6% vs. 57 ± 8%, P = 0.291). The E to A mitral wave amplitude ratio was higher in the CRT arm (1.3 ± 1.3 vs. 0.8 ± 0.4, P = 0.046) and the E wave deceleration time was longer (262 ± 83 ms vs. 205 ± 51 ms, P = 0.027). Left atrial volume was smaller in the CRT arm (64 ± 17 mL vs. 84 ± 25 mL, P = 0.035). Moreover, the functional class was lower in CRT patients (1.4 ± 0.6 vs. 1.8 ± 0.5, P = 0.010). During follow-up, CRT was associated with a lower risk of new-onset AF [hazard ratio = 0.37 (0.13-0.98), P = 0.046]. CONCLUSION: Cardiac resynchronization therapy proved superior to DDD-VPA in terms of better diastolic function, less left atrial enlargement and lower risk of new-onset AF, at 12 months. These data need to be confirmed in a larger trial with longer follow-up. CLINICAL TRIAL REGISTRATION: URL: http://clinicaltrials.gov/ Identifier: NCT02150538.

Metabolic changes in follicular fluids of patients treated with recombinant versus urinary human chorionic gonadotropin for triggering ovulation in assisted reproductive technologies: a metabolomics pilot study.

INTRODUCTION: The main goal of this retrospective cohort study is the assessment of the effects of administration of recombinant-hCG (r-hCG) versus urinary-hCG (u-hCG) on follicular fluid (FF) composition of women who underwent in vitro fertilization (IVF) treatments. MATERIALS AND METHODS: We selected 70 patients with infertility attributable to tubal diseases, unexplained infertility, and male factor. Metabolomics analysis of their FFs was performed by 1H nuclear magnetic resonance (1H NMR) spectroscopy in combination with multivariate analysis to interpret the spectral data. Univariate statistical analysis was applied to investigate the possible correlations between clinical parameters and between clinical parameters and metabolites identified by NMR. RESULTS: According to the type of hCG used, significant differences were detected in FFs of women with male factor and unexplained infertility, both in qualitative and quantitative terms, for some metabolites as cholesterol, citrate, creatine, ß-hydroxybutyrate, glycerol, lipids, amino acids (Glu, Gln, His, Val, Lys) and glucose. No significant difference was observed in women with tubal diseases. Besides, the number of MII oocytes in the u-hCG-treated groups correlates positively with glutamate in tubal disease and with glycerol in unexplained infertility. In the r-hCG-treated groups, the number of MII oocytes correlates positively with lipid in tubal disease, positively with citrate and negatively with glucose in male infertility. CONCLUSIONS: Metabolite composition of FF changes according to different type of hCG treatment and this can be related to oocyte development and subsequent outcome. According to the data of this study, different types of hCG should be used in relation to the diagnosis of infertility to obtain better results in inducing oocyte maturation in women undergoing IVF.

NMR metabolic profiling of follicular fluid for investigating the different causes of female infertility: a pilot study.

INTRODUCTION: Several metabolomics studies have correlated follicular fluid (FF) metabolite composition with oocyte competence to fertilization, embryo development and pregnancy but there is a scarcity of research examining the metabolic effects of various gynaecological diseases. OBJECTIVES: In this study we aimed to analyze and correlate the metabolic profile of FF from women who were following in vitro fertilization (IVF) treatments with their different infertility pathologies. METHODS: We selected 53 women undergoing IVF who were affected by: tubal diseases, unexplained infertility, endometriosis, polycystic ovary syndrome (PCOS). FF of the study participants was collected at the time of oocytes retrieval. Metabolomic analysis of FF was performed by nuclear magnetic resonance (NMR) spectroscopy. RESULTS: FF presents some significant differences in various infertility pathologies. Although it was not possible to discriminate between FF of control participants and women with tubal diseases and unexplained infertility, comparison of FF metabolic profile from control women with patients with endometriosis and PCOS revealed significant differences in some metabolites that can be correlated to the causes of infertility. CONCLUSION: NMR-based metabolic profiling may be successfully applied to find diagnostic biomarkers for PCOS and endometriosis and it might be also used to predict oocyte developmental potential and subsequent outcome.

NMR metabolomics study of follicular fluid in women with cancer resorting to fertility preservation.

PURPOSE: The purpose of this study was to evaluate the possible application of metabolomics to identify follicular fluid changes in cancer patients undergoing fertility preservation. Although metabolomics have been applied already in cancer studies, this is the first application on follicular fluid of cancer patients. METHODS: We selected for the study ten patients with breast cancer and lymphoma who resorted to oocyte cryopreservation to preserve fertility and ten healthy women undergoing in vitro fertilization treatments. Follicular fluid was collected at the time of oocytes retrieval. Metabolomic analysis of follicular fluids was performed by 1H-nuclear magnetic resonance (NMR) spectroscopy in combination with multivariate analysis to interpret the spectral data. Univariate statistical analysis was applied to find correlations between patients' features and metabolites identified by NMR. RESULTS: Partial least squares discriminant analysis allowed to discriminate samples from cancer patients and healthy controls. Univariate statistical analysis found significant correlations between patients' features and metabolites identified by NMR. This finding allowed to identify biomarkers to differentiate both healthy controls from cancer patients and the two different classes of oncological patients. CONCLUSION: The follicular fluids of cancer patients display significant metabolic alterations in comparison to healthy subjects. NMR-based metabolomics could be a valid prognostic tool for identifying and selecting the best cryopreserved oocytes and improving the outcome prediction in cancer women undergoing in vitro fertilization.

Safety and efficacy of pulmonary vein isolation using a surround flow catheter with contact force measurement capabilities: A multicenter registry.

INTRODUCTION: Pulmonary vein (PV) isolation is the cornerstone of catheter ablation in patients with atrial fibrillation (AF). Surround flow and contact force (CF) measurement capabilities might enhance procedure efficacy and safety. We report on the safety and midterm efficacy of a novel ablation catheter for PV isolation in patients with AF. METHODS AND RESULTS: Two hundred thirty-three consecutive patients (57 ± 11 years, 76% males, 51% with structural heart disease), referred for paroxysmal (157) or persistent (76) AF, underwent PV isolation by a surround flow catheter with CF measurement capability in four centers. Ablation was guided by electroanatomic mapping allowing radiofrequency (RF) energy delivery in the antral region aiming at PV isolation. Mean overall procedure time was 100 ± 42 minutes with a mean fluoroscopy time of 6 ± 5 minutes. Mean ablation time was 31±15 minutes; 99% of the targeted veins were isolated. The mean CF value during ablation was 13 ± 4 g. Intraprocedural early (30 minutes) PV reconnection occurred in 12% PVs, and all PVs were effectively reisolated. One pericardial effusion and five groin hematomas were reported. During a mean follow-up of 12 ± 6 months, 30 (12.9%) (10% paroxysmal AF vs. 18% persistent AF, P = 0.07) patients had an atrial arrhythmias recurrence. CONCLUSIONS: In this multicenter registry, RF ablation using a new surround flow catheter, with CF sensor, resulted as feasible, achieving a high rate of isolated PVs. Procedural and fluoroscopy times and success rates were comparable with other techniques with a low complication rate.

GnRH antagonist administered twice the day before hCG trigger combined with a step-down protocol may prevent OHSS in IVF/ICSI antagonist cycles at risk for OHSS without affecting the reproductive outcomes: a prospective randomized control trial.

PURPOSE: The purpose this study is to investigate whether a double antagonist dose (0.25 mg/12 h) administered the day before hCG trigger is effective in preventing ovarian hyperstimulation syndrome (OHSS) in GnRH antagonist IVF/intracytoplasmic sperm injection (ICSI) cycles at risk for OHSS. METHODS: This is a prospective randomized control study, conducted from November 2012 to January 2016. A total of 194 patients undergoing a IVF/ICSI GnRH antagonist cycle that were at risk of OHSS and chose to proceed with embryo transfer and avoid cycle cancellation or embryo cryopreservation were allocated into two groups. The inclusion criteria consisted of a rapid rise of oestradiol ≥ 3500 pg/ml combined with ≥ 18 follicles > 11 mm in diameter without any mature follicle > 16 mm, in any day of stimulation. Overall, 97 patients (intervention group A) received a double dose of GnRH antagonist (0.25 mg/12 h) the day before hCG while 97 patients (control group B) did not. Recombinant FSH administration was tapered to 100 IU/24 h the day of the allocation in both groups. RESULTS: Incidence of early-onset moderate/severe OHSS was significantly lower in intervention group A compared to control group B (0 vs 12.37%, P < 0.001). Clinical pregnancy rate per cycle (50.52 vs 42.27%, P = 0.249) was not significantly different between the two groups. Oestradiol (3263.471 ± 1271.53 vs 5233 ± 1425.17, P < 0.001), progesterone (0.93 ± 0.12 vs 1.29 ± 0.14, P < 0.001) and luteinizing hormone (1.42 ± 0.31 vs 1.91 ± 0.33, P < 0.001) were significantly lower in group A the day of the hCG triggering. CONCLUSION: The administration of a rescue double GnRH antagonist dose the day before hCG trigger may represent a safe alternative preventive strategy for early OHSS without affecting the reproductive outcomes. TRIAL REGISTRATION NUMBER: ISRCTN02750360.

Comparison of ThermoCool® Surround Flow catheter versus ThermoCool® catheter in achieving persistent electrical isolation of pulmonary veins: a pilot study.

INTRODUCTION: Aim of this study was to compare efficacy and safety of the new ThermoCool Surround Flow® catheter (SFc) versus the ThermoCool® (TCc) in achieving persistent circumferential electrical isolation of the pulmonary veins (PVs) in patients with paroxysmal atrial fibrillation (AF). METHODS AND RESULTS: This multicenter, randomized, controlled study enrolled patients suffering from paroxysmal AF. Randomization was run in a one-to-one fashion between radiofrequency ablation by TCc or SFc. Aim of PVs ablation was documentation of electrical isolation with exit/entrance block recorded on a circular catheter. Among the 106 enrolled patients, 52 (49.0%) were randomized to TCc and 54 (51.0%) to SFc. Total volume of infused saline solution during the procedure was lower in the SFc than in TCc group (752.7 ± 268.6 mL vs 1,165.9 ± 436.2 mL, P < 0.0001). Number of identified and isolated PVs was similar in the 2 groups. Number of PVs remaining isolated 30 minutes after ablation was higher in the SFc than in TCc group (95.2% vs 90.5%, P < 0.03), mainly driven by acute ablation result in the left PVs (96.1% vs 89.7%, P < 0.04). Complications were seldom and observed only in the TCc group (0% vs 3.84%, P < 0.03). At 6-month follow-up SFc patients reported a trend toward less AF recurrences compared to those in the TCc group (22.9% vs 27.0%, P = 0.69). CONCLUSION: PV isolation by SFc lowered the rate of left PV early reconnections and reduced the volume of infused saline solution while maintaining the safety profile of AF ablation.

A Pilot Study on Biochemical Profile of Follicular Fluid in Breast Cancer Patients.

Breast cancer (BC) is the most common type of cancer among women in almost all countries worldwide and is one of the oncological pathologies for which is indicated fertility preservation, a type of procedure used to help keep a person's ability to have children. Follicular fluid (FF) is a major component of oocyte microenvironment, which is involved in oocyte growth, follicular maturation, and in communication between germ and somatic cells; furthermore, it accumulates all metabolites during oocytes growth. To obtain information about changes on fertility due to cancer, we aimed at investigating potential biomarkers to discriminate between FF samples obtained from 16 BC patients and 10 healthy women undergoing in vitro fertilization treatments. An NMR-based metabolomics approach was performed to investigate the FF metabolic profiles; ELISA and western blotting assays were used to investigate protein markers of oxidative and inflammatory stress, which are processes closely related to cancer. Our results seem to suggest that FFs of BC women display some significant metabolic alterations in comparison to healthy controls, and these variations are also related with tumor staging.

Reduced fluoroscopy exposure during ablation of atrial fibrillation using a novel electroanatomical navigation system: a multicentre experience.

AIMS: Catheter ablation of atrial fibrillation (AF) focuses on pulmonary vein (PV) ablation with or without additional atrial substrate modification. These procedures require significant fluoroscopy exposure. A new 3D non-fluoroscopic navigation system (CARTO(®) 3 System, Biosense Webster, CA, USA) that allows precise location visualization of diagnostic and ablation catheters was evaluated for its impact on fluoroscopic exposure during AF ablation procedures. METHODS AND RESULTS: Two groups of patients were treated by our centres for drug refractory AF. One group was treated using the new CARTO(®) 3 system to guide catheter ablation (Group A, 117 patients). The other group was treated using the CARTO(®) XP system (Biosense Webster) 3 months previously (Group B, 123 patients). For both groups, circumferential PV ostia ablation was performed; PV isolation was validated using a circular catheter placed at each ostium. There was no difference in any clinical characteristics (age, sex, AF type, left atrium diameter and volume, and heart disease) among the two study groups. The mean number of PVs identified and isolated per patient was similar in both groups, as were the mean procedural duration and radiofrequency time. However, mean fluoroscopic time was significantly reduced in Group A (15.9±12.3 min) as compared with Group B (26±15.1 min) (P < 0.001). CONCLUSION: This multicentre observational study demonstrates a significant reduction of fluoroscopy exposure using a new 3D non-fluoroscopic mapping system to guide AF catheter ablation.

Are the Follicular Fluid Characteristics of Recovered Coronavirus Disease 2019 Patients Different From Those of Vaccinated Women Approaching in vitro Fertilization?

The aim of this pilot study is to evaluate if SARS-CoV-2 infection or vaccination against SARS-CoV-2 infection induce observable metabolic effects in follicular fluid of women who are following in vitro fertilization (IVF) treatments. The possible impact of coronavirus disease 2019 (COVID-19) on fertility and IVF outcome is considered. We have selected for this study: six women vaccinated against SARS-CoV-2 infection, five recovered COVID-19 patients, and we used nine healthy women as the control group. At the time of oocytes retrieval from participants in the study, follicular fluids were collected and metabolomic analysis was performed by 1H NMR spectroscopy in combination with multivariate analysis to interpret the spectral data. The search for antibody positivity in the follicular fluid aspirates was also carried out, together with the western blotting analysis of some inflammatory proteins, interleukin-6, tumor necrosis factor α (TNFα), and the free radical scavenger superoxide dismutase 2. Higher levels of Ala and Pro together with lower levels of lipids and trimethylamine N-oxide (TMAO) were found in follicular fluids (FFs) of vaccinated women while lower levels of many metabolites were detected in FFs of recovered COVID patients. Expression level of TNF-α was significantly lower both in recovered COVID-19 patients and vaccinated women in comparison to healthy controls.

Key characteristics for effective acute pulmonary vein isolation when using a novel cryoballoon technology: insights from the CHARISMA registry.

PURPOSE: A new cryoballoon (CB) technology (POLARx™; Boston Scientific) for pulmonary vein (PV) isolation in patients with atrial fibrillation (AF) has recently been introduced. The aim of this study was to evaluate procedural and biophysical parameters resulting in acute PV isolation when using this new CB. METHODS: We assessed the first 69 consecutive patients indicated for AF ablation who underwent PV isolation by means of a novel CB system. Procedural metrics were prospectively recorded. RESULTS: A total of 274 PVs were targeted in 69 patients. PV isolation was achieved in all patients by means of cryoablation alone. The median time to isolation (TTI) was 44 [31-68] s (median temperature at TTI = - 49 [- 53 to - 41] °C). The median duration of CB ablation was 180 [180 to 240] s. The median nadir temperature was - 56.0 [- 61 to - 52] °C, and the median thaw time to 0 °C was 18 [15-21] s. The median grade of PV occlusion was 4 [3 to 4]. On the basis of ROC analysis, we defined the following cut-off values for acute PV isolation: - 56 °C for nadir temperature (sensitivity = 73.3%, specificity = 64.6%, AUC = 0.716; positive predictive value = 88.1%), 30 s for TTT (60.2%, 53.3%, 0.578; 79.7%), thaw time > 17 s (65.3%, 70.0%, 0.709; 86.9%), and grade of PV occlusion = 4 (79.4%, 66.7%, 0.738; 88.5%). No major procedure-related adverse events were observed at 30-day post-procedure. CONCLUSIONS: The new POLARx™ CB appears to be effective and safe. A nadir temperature of - 56 °C, a thaw time to 0 °C ≥ 17 s, and complete PV occlusion were the best predictors of acute PV isolation. 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.

Does catheter ablation cure atrial fibrillation? Single-procedure outcome of drug-refractory atrial fibrillation ablation: a 6-year multicentre experience.

Aims In the last decade, several approaches to ablating triggers and substrates of atrial fibrillation (AF) have been developed. However, most studies have reported data only on short- or medium-term follow-up. The aim of this study was to investigate whether the 1-year efficacy of catheter ablation for AF is predictive of long-term clinical success. Methods and results Between February 2001 and October 2003, 229 consecutive patients affected by drug-refractory paroxysmal or persistent AF underwent a single radiofrequency catheter ablation procedure (anatomical approach in 146 patients and electrophysiologically guided approach in 83 patients). Of these patients, 177 (mean age 59.1 +/- 10.5 years, 57.6% with paroxysmal AF) were free from any atrial arrhythmia recurrence after 12 months. These 177 patients were subsequently followed up for at least another 24 months, by means of electrocardiogram and 24 h Holter monitoring. After a mean follow-up of 49.7 +/- 13.3 months (range 36-83 months), 58.2% of the patients were free from any atrial arrhythmia recurrence (39.5% without antiarrhythmic drugs). The actuarial atrial arrhythmia recurrence rate was 13.0% at 2 years, 21.8% at 3 years, 35.0% at 4 years, 46.8% at 5 years, and 54.6% at 6 years. Atrial arrhythmia-free survival was similar in patients with paroxysmal or persistent AF, with and without antiarrhythmic drugs during the follow-up, who underwent electrophysiologically guided pulmonary vein (PV) isolation or anatomical PV ablation. Conclusion Even patients in whom catheter ablation prevents AF recurrence for 1 year should not be considered 'cured', since >40% of them will suffer AF recurrence over a long-term clinical follow-up.

Role of pulmonary veins isolation in persistent atrial fibrillation ablation: the pulmonary vein isolation in persistent atrial fibrillation (PIPA) study.

BACKGROUND: The role of pulmonary veins (PV) isolation in patients with persistent atrial fibrillation (AF) is still debated. The aim of this study was to evaluate the adjunctive role of PV isolation in patients with persistent AF who underwent circumferential PV ablation (anatomical approach). METHODS: We treated 97 consecutive patients presenting with drug-refractory persistent AF by an anatomical approach (group A, n = 36, mean age = 60 +/- 8 years, 29 males) or an integrated approach (group B, n = 61, mean age 59 +/- 10 years, 48 males). In all patients, radiofrequency (RF) ablation was performed by means of a nonfluoroscopic navigation system, in order to anatomically create circumferential lines around the PV. In group B, the persistence of PV potentials was ascertained with a multipolar circular catheter. If PV potentials persisted, RF energy targeting the electrophysiological breakthroughs was delivered to disconnect the PV. Past a 2-month period of observation, success was defined as absence of any atrial tachyarrhythmia recurrence lasting >30 seconds. RESULTS: Total procedure duration (220 +/- 62 minutes vs 140 +/- 43 minutes, P < 0.001), fluoroscopy time (35 +/- 15 minutes vs 17 +/- 9 minutes, P < 0.001), and RF delivery time (48 +/- 22 minutes vs 27 +/- 9 minutes, P < 0.001) were significantly longer in group B than in group A. One cardiac perforation occurred in group A. After 15 +/- 9.1 months, 21 patients in group A (58%) and 34 patients in group B (56%) were free of atrial tachyarrhythmia recurrence (P = 0.9). CONCLUSIONS: In patients with persistent AF, who underwent an anatomical approach, electrophysiological confirmation of PV disconnection significantly increased the fluoroscopy and procedural times, without effect on the long-term outcomes.

Long-term outcomes of CRT-PM versus CRT-D recipients.

OBJECTIVE: To compare the rates of all-cause mortality in recipients of cardiac resynchronization therapy devices without (CRT-PM) versus with defibrillator (CRT-D). METHODS: Between February 1999 and July 2004, 233 patients (mean age = 69 +/- 8 years, 180 men) underwent implantation of CRT-PM or CRT-D devices. New York Heart Association (NYHA) heart failure functional class II was present in 11%, class III in 69%, and class IV in 20% of patients; mean left ventricle ejection fraction (LVEF) was 26.5 +/- 6.5 %, 48% presented with idiopathic dilated cardiomyopathy and 49% with ischemic heart disease. Cox multiple variable regression analysis was performed in search of predictors of death. RESULTS: The clinical characteristics of the 117 CRT-PM and 116 CRT-D recipients were similar, except for LVEF (28.2 +/- 6.2% vs 25.0 +/- 6.5%, respectively; P < 0.001), and ischemic versus nonischemic etiology of heart failure (41% vs 56%, respectively P = 0.02). Over a mean follow-up of 58 +/- 15 months, no significance difference in overall mortality rate was observed between the two study groups. Male sex, NYHA functional class IV, and atrial fibrillation at implant were significant predictors of death. CONCLUSIONS: There was no difference in long-term survival rate among patients with CRT-D versus CRT-PM, although CRT-D more effectively lowered the sudden death rate. Male sex, NYHA functional class IV, and atrial fibrillation predicted the worst prognosis.

Safety and efficacy of atrial fibrillation ablation guided by Ablation Index module.

PURPOSE: Reconnection of pulmonary veins (PVs) remains common following radiofrequency catheter ablation for atrial fibrillation (AF). Ablation Index (AI) is a novel ablation quality marker that incorporates stability, contact force (CF), time, and power in a weighted formula. Its use seems to improve lesion durability. This is a prospective, single-arm registry to investigate on the safety and mid-term efficacy of AF ablation guided by the AI. METHODS: One hundred fifty-six consecutive patients (mean age 58 ± 10 years, 49% males, 44% with structural heart disease) referred for paroxysmal (124) or persistent (32) AF underwent antral PV isolation using a surround flow CF-sensing catheter guided by the AI. Radiofrequency was delivered targeting interlesion distance ≤ 6 mm and Ablation Index of 330-350 at posterior wall and 400-450 at anterior wall. RESULTS: Mean overall procedure time was 95 ± 30 min with a mean fluoroscopy time of 5 ± 6 min. Mean ablation time was 26 ± 10 min, 627/628 targeted PV were isolated. One pericardial effusion and two groin hematomas were reported; none required intervention. During a mean follow-up of 14 ± 6 months, 17 (10.8%) (9% paroxysmal AF vs 22% persistent AF, p = 0.09) patients had an atrial arrhythmia recurrence. CONCLUSIONS: PV ablation guided by AI resulted feasible, achieving a high rate of isolated PVs, with a low complication rate, and allowed a high single-procedure arrhythmia-free survival at 14 months.

Incidence, predictors, and impact on outcome of increased left ventricular latency in patients undergoing cardiac resynchronization therapy.

PURPOSE: Latency during left ventricle (LV) pacing has been suggested as a potential cause of ineffectual biventricular pacing. We assessed the incidence, predictors, and impact on outcome of increased LV latency in 274 patients undergoing cardiac resynchronization therapy (CRT). METHODS: On implantation, the latency interval was defined as the shortest stimulus-to-QRS onset interval in any lead of the 12-lead ECG. A stimulus-to-QRS onset interval ≥ 40 ms was used to define the presence of increased LV latency. RESULTS: Increased LV latency was observed in 55 patients (20%). On multivariate analysis, only ischemic etiology proved to be a predictor of increased LV latency. On 12-month echocardiographic evaluation, 68% patients showed a ≥ 15% decrease in LV end systolic volume (74% patients with increased LV latency, 67% patients without increased LV latency (p = 0.58). The presence of increased LV latency was not associated with a different clinical response to CRT. CONCLUSIONS: Increased LV latency occurred in almost 20% of patients undergoing CRT and was more frequent in patients with ischemic heart disease. The presence of increased LV latency does not seem to have an impact on echocardiographic or clinical response to CRT.

Adherence to 2016 European Society of Cardiology guidelines predicts outcome in a large real-world population of heart failure patients requiring cardiac resynchronization therapy.

BACKGROUND: Professional guidelines are based on the best available evidence. However, patients treated in clinical practice may differ from those included in reference trials. OBJECTIVE: The aim of this study was to evaluate the effects of cardiac resynchronization therapy (CRT) in a large population of patients implanted with a CRT device stratified in accordance with the 2016 European heart failure (HF) guidelines. METHODS: We collected data on 930 consecutive patients from the Cardiac Resynchronization Therapy MOdular REgistry. The primary end point was a composite of death and HF hospitalization. RESULTS: Five hundred sixty-three (60.5%) patients met class I indications, 145 (15.6%) class IIa, 108 (11.6%) class IIb, and 114 (12.3%) class III. After a median follow-up of 1001 days, 120 (14.7%) patients who had an indication to CRT had died and 71 (8.7%) had been hospitalized for HF. The time to the end point was longer in patients with a class I indication (hazard ratio 0.55; 95% confidence interval 0.39-0.76; P = .0001). After 12 months, left ventricular (LV) end-systolic volume had decreased by ≥15% in 61.5% (320/520) of patients whereas in 57.5% (389/676) of patients the absolute LV ejection fraction improvement was ≥5%. Adherence to class I was also associated with an absolute LV ejection fraction increase of >5% (P = .0142) and an LV end-systolic volume decrease of ≥15% (P = .0055). CONCLUSION: In our population, ∼60% of patients underwent implantation according to the 2016 European HF guidelines class I indication. Adherence to class I was associated with a lower death and HF hospitalization rates and better LV reverse remodeling.

Maximization of interventricular conduction time by means of quadripolar leads for cardiac resynchronization therapy.

PURPOSE: Identifying the left ventricular (LV) site associated with the maximum spontaneous interventricular conduction time (right ventricle (RV)-to-LV interval) has proved to be an effective strategy for optimal LV pacing site selection in cardiac resynchronization therapy (CRT). The aim of our study was to determine whether quadripolar LV lead technology allows RV-to-LV interval maximization. METHODS: We enrolled 108 patients undergoing implantation of a CRT system using an LV quadripolar lead and 114 patients who received a bipolar lead. On implantation, the RV-to-LV interval was measured for the dipole of the bipolar leads and for each electrode of the LV lead (tip, ring 2, ring 3, ring 4). RESULTS: In the quadripolar group, the mean RV-to-LV interval ranged from 90 ± 33 ms (tip) to 94 ± 32 ms (R4) (p > 0.05 for all comparisons). In 55 (51%) patients, the RV-to-LV interval was > 80 ms at all electrodes, while in 27 (25%) patients, no electrodes were associated with an RV-to-LV interval > 80 ms. At least one LV pacing electrode was associated with an RV-to-LV interval > 80 ms in 62 (70%) patients with a short (36 mm) inter-electrode distance, and in 19 (95%, p = 0.022) of those with a long distance (50.5 mm). In the bipolar group, the mean RV-to-LV interval was 72 ± 37 ms (p < 0.001 versus quadripolar). The RV-to-LV interval was > 80 ms in 44 (39%) patients (p < 0.001 versus quadripolar leads with both short and long inter-electrode distance). CONCLUSIONS: Quadripolar leads allow RV-to-LV interval maximization. An optimal RV-to-LV interval seems achievable in the majority of patients, especially if the leads present a long inter-electrode distance.