Integration of a Smartphone HF-Dedicated App in the Remote Monitoring of Heart Failure Patients with Cardiac Implantable Electronic Devices: Patient Access, Acceptance, and Adherence to Use.

(200 w) Introduction. Remote monitoring (RM) of cardiac implantable electronic device (CIED) diagnostics helps to identify patients potentially at risk of worsening heart failure (HF). Additionally, knowledge of patient HF-related symptoms is crucial for decision making. Patient smartphone applications may represent an ideal option to remotely collect this information. PURPOSE: To assess real-world HF patient access, acceptance, and adherence to use of an HF-dedicated smartphone application (HF app). METHODS: In this study, 10 Italian hospitals administered a survey on smartphone/app use to HF patients with CIED. The subgroup who accepted it downloaded the HF app. Mean 1-year adherence of the HF app use was evaluated. RESULTS: A total of 495 patients (67 ± 13 years, 79% males, 26% NYHA III-IV) completed the survey, of which 84% had access to smartphones and 85% were willing to use the HF app. In total, 311/495 (63%) downloaded the HF app. Patients who downloaded the HF app were younger and had higher school qualification. Patients who were ≥60 years old had higher mean 1-year adherence (54.1%) than their younger counterparts (42.7%; p < 0.001). Hospitals with RM-dedicated staff had higher mean 1-year patient adherence (64.0% vs. 33.5%; p < 0.001). Adherence to HF app decreased from 63.3% (weeks_1-13) to 42.2% (weeks_40-52, p < 0.001). CONCLUSIONS: High access and acceptance of smartphones/apps by HF patients with CIED allow HF app use for RM of patient signs/symptoms. Younger patients with higher school qualifications are more likely to accept HF app; however, older patients have higher long-term adherence.

Incremental Value of Right Atrial Strain Analysis to Predict Atrial Fibrillation Recurrence After Electrical Cardioversion.

BACKGROUND: Although the assessment of left atrial (LA) mechanics has been reported to refine atrial fibrillation (AF) risk prediction, it doesn't completely predict AF recurrence. The potential added role of right atrial (RA) function in this setting is unknown. Accordingly, this study sought to evaluate the added value of RA longitudinal reservoir strain (RASr) for the prediction of AF recurrence after electrical cardioversion (ECV). METHODS: We retrospectively studied 132 consecutive patients with persistent AF who underwent elective ECV. Complete two-dimensional and speckle-tracking echocardiography analyses of LA and RA size and function were obtained in all patients before ECV. The end point was AF recurrence. RESULTS: During a 12-month follow-up, 63 patients (48%) showed AF recurrence. Both LASr and RASr were significantly lower in patients experiencing AF recurrence than in patients with persistent sinus rhythm (LASr, 10% ± 6% vs 13% ± 7%; RASr, 14% ± 10% vs 20% ± 9%, respectively; P < .001 for both). Right atrial longitudinal reservoir strain (area under the curve = 0.77; 95% CI, 0.69-0.84; P < .0001) was more strongly associated with the recurrence of AF after ECV than LASr (area under the curve = 0.69; 95% CI, 0.60-0.77; P < .0001). Kaplan-Meier curves showed that patients with both LASr ≤ 10% and RASr ≤ 15% had a significantly increased risk for AF recurrence (log-rank, P < .001). However, at multivariable Cox regression, RASr (hazard ratio, 3.26; 95% CI, 1.73-6.13; P < .001) was the only parameter independently associated with AF recurrence. Right atrial longitudinal reservoir strain was more strongly associated with the occurrence of AF relapse after ECV than LASr, and LA and RA volumes. CONCLUSION: Right atrial longitudinal reservoir strain was independently and more strongly associated than LASr with AF recurrence after elective ECV. This study highlights the importance of assessing the functional remodeling of both the RA and LA in patients with persistent AF.

Catheter Ablation for Atrial Fibrillation in Structural Heart Disease: A Review.

Atrial fibrillation (AF) is the most common arrhythmia encountered in clinical practice. Patients with structural heart disease (SHD) are at an increased risk of developing this arrhythmia and are particularly susceptible to the deleterious hemodynamic effects it carries. In the last two decades, catheter ablation (CA) has emerged as a valuable strategy for rhythm control and is currently part of the standard care for symptomatic relief in patients with AF. Growing evidence suggests that CA of AF may have potential benefits that extend beyond symptoms. In this review, we summarize the current knowledge of this intervention on SHD patients.

Optimized radiofrequency lesions through local impedance guidance for effective CTI ablation in right atrial flutter.

BACKGROUND: Although radiofrequency (RF) catheter ablation of cavo-tricuspid isthmus (CTI) is an established treatment for typical right atrial flutter (RAFL), it remains to be established whether local tissue impedance (LI) is able to predict effective CTI ablation and what LI drop values during ablation should be used to judge a lesion as effective. We aimed to investigate the ability of LI to predict ablation efficacy in patients with RAFL. METHODS: RF delivery was guided by the DirectSense™ algorithm. Successful single RF application was defined according to a defragmentation of atrial potentials (DAP), reduction of voltage (RedV) by at least 80% or changes on unipolar electrogram (UPC). The ablation endpoint was the creation of bidirectional conduction block (BDB) across the isthmus. RESULTS: 392 point-by-point RF applications were analyzed in 48 consecutive RAFL patients. The mean baseline LI was 105.4 ± 12Ω prior to ablation and 92.0 ± 11Ω after ablation (p < 0.0001). According to validation criteria, absolute drops in impedance were larger at successful ablation sites than at ineffective ablation sites (DAP: 17.8 ± 6Ω vs. 8.7 ± 4Ω; RedV: 17.2 ± 6Ω vs. 7.8 ± 5Ω; UPC: 19.6 ± 6Ω vs. 10.1 ± 5Ω, all p < 0.0001). LI drop values significantly increased according to the number of criteria satisfied (ranging from 7.5Ω to 19.9). BDB was obtained in all cases. No procedure-related adverse events were reported. CONCLUSIONS: A LI-guided approach to CTI ablation was safe and effective in treating RAFL. The magnitude of LI drop was associated with effective lesion formation and BDB and could be used as a marker of ablation efficacy. CLINICAL TRIAL REGISTRATION: Catheter Ablation of Arrhythmias with a High-Density Mapping System in Real-World Practice (CHARISMA). URL: http://clinicaltrials.gov/ Identifier: NCT03793998.

Physical Activity in Patients With Heart Failure During and After COVID-19 Lockdown: Single-Center Observational Retrospective Study.

BACKGROUND: The COVID-19 pandemic forced several European governments to impose severe lockdown measures. The reduction of physical activity during the lockdown could have been deleterious. OBJECTIVE: The aim of this observational, retrospective study was to investigate the effect of the lockdown strategy on the physical activity burden and subsequent reassessment in a group of patients with heart failure who were followed by means of remote monitoring. METHODS: We analyzed remote monitoring transmissions during the 3-month period immediately preceding the lockdown, 69 days of lockdown, and 3-month period after the first lockdown in a cohort of patients with heart failure from a general hospital in Lombardy, Italy. We compared variation of daily physical activity measured by cardiac implantable electrical devices with clinical variables collected in a hospital database. RESULTS: We enrolled 41 patients with heart failure that sent 176 transmissions. Physical activity decreased during the lockdown period (mean 3.4, SD 1.9 vs mean 2.9, SD 1.8 hours/day; P<.001) but no significant difference was found when comparing the period preceding and following the lockdown (-0.0007 hours/day; P=.99). We found a significant correlation between physical activity reduction during and after the lockdown (R2=0.45, P<.001). The only significant predictor of exercise variation in the postlockdown period was the lockdown to prelockdown physical activity ratio. CONCLUSIONS: An excessive reduction of exercise in patients with heart failure decreased the tolerance to exercise, especially in patients with more comorbidities. Remote monitoring demonstrated exercise reduction, suggesting its potential utility to encourage patients to maintain their usual physical activity levels.

Comment to "Chronic disease management in heart failure: focus on telemedicine and remote monitoring".

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Impact of the Pattern of Atrial Fibrillation on Stroke Risk and Mortality.

Thromboembolism is the most serious complication of AF, and oral anticoagulation is the mainstay therapy. Current guidelines place all AF types together in terms of anticoagulation with the major determinants being associated comorbidities translated into risk marker. Among patients in large clinical trials, those with non-paroxysmal AF appear to be at higher risk of stroke than those with paroxysmal AF. Higher complexity of the AF pattern is also associated with higher risk of mortality. Moreover, continuous monitoring of AF through cardiac implantable devices provided us with the concept of 'AF burden'. Usually, the larger the AF burden, the higher the risk of stroke; however, the relationship is not well characterised with respect to the threshold value above which the risk increases. The picture is more complex than it appears: AF and underlying disorders must act synergically respecting the magnitude of its own characteristics, which are the amount of time a patient stays in AF and the severity of associated comorbidities.

Cryoablation for pulmonary veins isolation in obese patients with atrial fibrillation compared to nonobese patients.

BACKGROUND: Pulmonary veins isolation (PVI) by cryoballoon (CB) ablation is marginally represented in clinical studies in obese patients. The aim of this analysis was to evaluate the safety and efficacy of CB-PVI in a large cohort of overweight and obese patients from the 1STOP project. METHODS: From 2012 to 2018, 2048 patients with atrial fibrillation (AF) (70% male, 59 ± 11 years; 75% paroxysmal AF) underwent index CB-PVI. The patient data were separated into three cohorts for statistical evaluation, including: normal weight (body mass index [BMI] < 25 kg/m2 ), overweight (BMI = 25-30 kg/m2 ), and obese patients (BMI > 30 kg/m2 ). RESULTS: Out of 2048 patients, 693 (34%) patients had a BMI < 25 and were deemed as normal. There were 944 (46%) patients categorized as overweight (BMI = 25-30) and 411 (20%) as obese (BMI > 30). Overweight or obese patients were more often in persistent AF, had more frequently hypertension and diabetes, had higher CHA2 DS2 -VASc score, and had a number of failed antiarrhythmic drug (AAD). Periprocedural complication rates were similar among the three cohorts. The 12-month freedom from AF recurrence was 76.4% in the normal BMI group as compared to 79.2% in the overweight and 73.5% in the obese group (p = .35). However, 48% of overweight patients were on AAD treatment during the follow-up. By multivariate analysis, BMI was not a predictor for AF recurrence following the index CB-PVI. CONCLUSION: CB-PVI in obese patients is a safe procedure. Increased BMI (either moderate or severe) does not seem to be associated with a worse outcome or to a different rate of AAD discontinuation at 12 months.

Second European Society of Cardiology Cardiac Resynchronization Therapy Survey: the Italian cohort.

AIM: Adherence to guidelines was not homogeneous in Europe, according to the survey on cardiac resynchronization therapy conducted in 2008-2009. The aim of our study was to compare the results in the Italian and European cohorts of the Second European Cardiac Resynchronization Therapy Survey. METHODS: Patients' characteristics, procedural data and follow-up were collected. Italian records were compared with European countries. RESULTS: Italian hospitals enrolled 526 patients. The italian cohort was older (71.6 ±â€Š9.5 vs. 68.4 ±â€Š10.8; P < 0.00001), had less severe NYHA class (>II 47.2 vs. 59.6%; P < 0.00001), higher ejection fraction (30.3 ±â€Š7.4 vs. 28.4 ±â€Š8.2%; P < 0.00001), and less atrial fibrillation prevalence (34.4 vs. 41.2%; P = 0.00197) than the European cohort. Italian patients were more frequently hospitalized for heart failure in the previous year (51.9 vs. 46.2%; P = 0.01118) and had lower mean QRS duration (151 ±â€Š26 vs. 157 ±â€Š27 ms; P < 0.0001). CRT-D were more often implanted in Italian patients (79.3 vs. 69.3%; P < 0.00001). The complication rate was similar (4.6% vs. 5.6%; ns). The rate of use of ACEi/ARBs in Italy was lower than in Europe (77.2 vs. 86.9%; P < 0.00001). Patients were followed up in the implantation centre (92.1 vs. 86%; P = 0.00014), but rarely with remote monitoring (25.9 vs. 30%; P = 0.04792). CONCLUSION: The survey demonstrates important similarities as well as substantial differences regarding most of the aspects evaluated. Efforts to implement adherence to guidelines will be endorsed in Italy.

Cryoballoon Ablation in Patients With Paroxysmal Atrial Fibrillation: An Evaluation of Cohorts With and Without Structural Heart Disease.

BACKGROUND: Pulmonary vein isolation (PVI) is the most widely adopted strategy for paroxysmal atrial fibrillation (PAF) ablation. Limited evidence on acute results and late outcomes of cryoballoon (CB)-PVI in patients with structural heart disease (SHD) exist. The aim of this analysis was to compare acute procedural results and the 1-year recurrence rate of a single CB-PVI procedure in a PAF population with and without SHD. METHOD: From April 2012 to May 2017, a total of 2,031 patients with AF underwent CB-PVI and were followed prospectively in the framework of the One Shot TO Pulmonary vein isolation (1STOP) ClinicalService project, involving 36 Italian cardiology centres. We identified patients with SHD according to criteria proposed by current ESC guidelines: left ventricular (LV) systolic or diastolic dysfunction, long-standing hypertension with LV hypertrophy, and/or other structural heart disease. Data on procedural outcomes and long-term freedom from AF recurrence were evaluated. RESULTS: Our population consisted of 1,452 patients, of whom 282 (19.4%) were classified as having SHD. Compared to non-SHD patients, the SHD cohort was older (mean ± standard deviation, 62.9 ± 9.0 vs 58.2 ± 11.4 years; p < 0.001), was more frequently male (79.1% vs 69.8%; p < 0.002), had a higher thrombo-embolic risk (CHA2DS2VASc ≥2: 63.4% vs 40.2%; p < 0.001), had a higher body mass index (27.7 ± 3.9 vs 26.4 ± 3.9 kg/m2; p < 0.001), had a larger atrial diameter (43.8 ± 7.0 vs 40.2 ± 5.8 mm; p < 0.001), and had a lower LV ejection fraction (57.2 ± 7.7% vs 60.7 ± 6.0%; p < 0.001). At the time of ablation, 73% of patients were on class Ic or III anti-arrhythmic drugs. Procedure time (106.9 ± 41.5 vs 112.1 ± 46.8 min; p = 0.248), fluoroscopic time (28.7 ± 14.7 vs 28.6 ± 15.2 min; p = 0.819), and complication rate (3.9% vs 4.8%; p = 0.525) were not different between the SHD and non-SHD cohorts. However, the acute success rate (98.9% vs 97.7%; p = 0.016) was higher in patients with SHD. After a follow-up of 13.4 ± 12.8 months, freedom from symptomatic recurrence was 78.0% for SHD and 78.4% for non-SHD (p = 0.895). Recurrence rate was not related to either left atrial size or LVEF. In the SHD cohort, Class Ic or III anti-arrhythmic drugs treatment decreased from 70.7% of patients before ablation to 28.7% of patients after CB-PVI (p = 0.001). CONCLUSIONS: CB-PVI was extensively applied to treat patients with PAF. Unlike previous PVI experiences, the acute success and recurrence rate after a single procedure was not related to the presence of SHD or to the degree of cardiac remodelling. Further studies are required to define whether CB-PVI has a useful role in patients with a significantly reduced ejection fraction as those patients were under-represented in the current population.

[Safety and efficacy of early discharge and outpatient rehabilitation after myocardial infarction for low-risk patients]. / Sicurezza ed efficacia della dimissione precoce associata a riabilitazione ambulatoriale dopo infarto miocardico nel paziente a basso rischio.

BACKGROUND: Guidelines recommend early discharge and rehabilitation after ST-elevation myocardial infarction (STEMI) in low-risk patients. However, low risk is not established according to well-defined criteria and often it depends on subjective judgment. The aim of this real-life study is to confirm that early discharge is safe in patients at low risk according to selected criteria and subsequent outpatient rehabilitation is associated with clinical benefits. METHODS: Patients with STEMI treated with primary percutaneous coronary intervention from October 2010 to October 2017, identified as being at low risk (according to predefined criteria), discharged by day 5, were studied retrospectively. Basal characteristics and 30-day outcome were evaluated and a comparison was made between patients who completed or did not complete outpatient rehabilitation. RESULTS: We enrolled 193 STEMI patients treated with percutaneous coronary intervention for STEMI, early discharged and at low risk: 132 completed outpatient rehabilitation and 61 did not. The increase in cardiac enzymes and the occurrence of arrhythmias were the only independent predictors of completion of outpatient rehabilitation. After 30 days from discharge, adverse events were rare and not significantly different between groups. Optimal pharmacological therapy was achieved more often in the rehabilitation group (58.3% vs 44.3%; p<0.05). CONCLUSIONS: Early discharge within 5 days of STEMI has been proved feasible and safe in our population of well-defined low-risk patients. Early participation in a rehabilitation program was associated with a more adequate titration of therapy.

Cryoablation for paroxysmal and persistent AF in patients with structural heart disease and preserved ejection fraction: Clinical outcomes from 1STOP, a multicenter observational project.

BACKGROUND: Pulmonary vein isolation (PVI) is an accepted strategy for paroxysmal atrial fibrillation (PAF) and persistent AF (PerAF) ablation. Limited data are available on outcomes of cryoballoon (CB) PVI in patients with structural heart disease (SHD). The purpose is to assess the clinical efficacy of a single CB-PVI procedure in patients with PAF or PerAF who also have SHD. METHODS: From April 2012, 460 AF patients with concomitant SHD underwent CB-PVI and were followed prospectively in the framework of the 1STOP ClinicalService® project. Data on procedural outcomes and long-term freedom from AF recurrence were evaluated. Out of 460 subjects, 282 patients (61%) had PAF and 178 (39%) PerAF. RESULTS: SHD patients were predominantly male (80.9%), old (62.8±8.9 years), with preserved functional capacity (New York Heart Association class >1: 39.4%), high cardioembolic risk (CHA2DS2VASc score ≥2: 69.3%), and conserved left ventricular ejection fraction (56.5±8% LVEF). Both subjects with PAF and PerAF had similar baseline clinical characteristics except for left atrial diameter (43.8±7 vs. 45.7±7mm) and area (22.9±5.2 vs. 25.1±4.4cm2), respectively. Procedure time and fluoroscopic time as well as the rate of procedural complications were not different between subjects with PAF and PerAF. After a mean follow-up of 12 months, antiarrhythmic drug therapy had dropped from 71.7% before ablation to 33.6% post-ablation (p<0.001) and the freedom from symptomatic AF recurrence was 78% for PAF and 77% for PerAF (p=0.793). Furthermore, atrial arrhythmia recurrence rate was not related to SHD. CONCLUSIONS: In a large multicenter, real-world cohort, CB-PVI was used to treat patients with PAF and PerAF who also had SHD. The arrhythmia recurrence after a single procedure was not related to either the degree of cardiac structural remodeling or the type of AF, and the rate of AF recurrence was lower than previously reported in patients with SHD in other cohort series using focal radiofrequency catheter ablation. CLINICAL TRIAL REGISTRATION: clinicaltrials.gov (NCT01007474).

Correlation between pulmonary artery pressure and thoracic impedance: Insights from daily monitoring through an implanted device in chronic heart failure.

BACKGROUND: Thoracic impedance (TI) decrease and pulmonary artery pressure (PAP) elevation precede acute decompensation in congestive heart failure (HF). However, the relationship between TI and PAP has been studied only in the context of acute decompensation. METHODS: This prospective, observational study enrolled subjects with reduced ejection fraction HF, previously implanted with an ICD capable of measuring TI. Patients underwent implantation of a sensor for direct measurement of PAP (CardioMEMs™). Both TI and PAP were remotely monitored daily during follow up. Investigators were blinded to PAP values during the first three months, then PAP was used as a guide to therapy. RESULTS: Ten patients were followed up for 405±141days (3720 patient-days). During hemodynamic guided therapy, diastolic PAP (dPAP) decreased from 27.8±10.2mmHg to 24.0±8.0mmHg (p<0.001); non-significant variations of TI were observed. A significant negative correlation was found between the variations of TI and PAP vs. baseline (p<0.001). Episodes of sustained increase of PAP preceded subsequent periods of TI decrease by 5.6±3.9days, but the former were poor predictors of the latter (sensitivity 0.37). CONCLUSIONS: Our study confirms the strict correlation that exists between left ventricular filling pressures and lung water content, estimated by dPAP and TI, respectively. However, dPAP acute variation analysis showed a limited value in predicting subsequent episodes of TI decrease.

Retrospective application of Program to Access and Review Trending iNformation and Evaluate coRrelation to Symptoms in patients with Heart Failure criteria for the remote management of patients with cardiac resynchronisation therapy.

Aim The Program to Access and Review Trending iNformation and Evaluate coRrelation to Symptoms in patients with Heart Failure (PARTNERS HF) trial elaborated a multiparametric model for prediction of acute decompensation in advanced heart failure patients, based on periodical in office data download from cardiac resynchronisation devices. In this study, we evaluated the ability of the PARTNERS HF criteria to detect initial decompensation in a population of moderate heart failure patients under remote monitoring. Methods We retrospectively applied the PARTNERS HF criteria to 1860 transmissions from 104 patients (median follow up 21 months; range 1-67 months), who were enrolled in our programme of telemedicine after cardiac resynchronisation therapy. We tested the ability of a score based on these criteria to predict any acute clinical decompensation occurring in the 15 days following a transmission. Results In 441 cases, acute heart failure was diagnosed after the index transmission. The area under the curve (AUC) of the score for the diagnosis of acute decompensation was 0.752 (confidence interval (CI) 95% 0.728-0.777). The best score cut-off was consistent with the results of PARTNERS HF: with a score ≥2, sensitivity was 75% and specificity 68%. The odds ratio for events was 6.24 (CI 95% 4.90-7.95; p < 0.001). Conclusions When retrospectively applied to remote monitoring transmissions and arranged in a score, PARTNERS HF criteria could identify HF patients who subsequently developed acute decompensation. These results warrant prospective studies applying PARTNERS HF criteria to remote monitoring.

Antihypertensive effect of barnidipine 10 mg or amlodipine 5 to 10 mg once daily in treatment-naive patients with essential hypertension: A 24-week, randomized, open-label, pilot study.

BACKGROUND: Dihydropyridine calcium antagonists are largely employed for the treatment of hypertension, coronary heart disease, and heart failure. OBJECTIVE: The aim of our study was to compare the antihypertensive effect of the dihydropyridine calcium antagonists barnidipine and amlodipine. METHODS: This was a 24-week, randomized, open-label, pilot study. Consecutive treatment-naive patients with grade I or II essential hypertension (office sitting systolic blood pressure [BP] of 140-179 mm Hg and diastolic BP of 90-109 mm Hg) were enrolled. The primary end points were the effect of treatment with either barnidipine 10 mg or amlodipine 5 mg once daily on office and ambulatory BP, left ventricular mass index (LVMI), and markers of cardiac damage, serum procollagen type I C-terminal propeptide, and plasma amino-terminal pro-B-type natriuretic peptide concentrations. Patients were assessed at enrollment, and 12 and 24 weeks. During each visit, the prevalence of adverse events (AEs) was also monitored using spontaneous reporting, patient interview, and physical examination, the relationship to study drug being determined by the investigators. Compliance with treatment was assessed at each study visit by counting returned tablets. RESULTS: Thirty eligible patients (20 men, 10 women; mean [SD] age, 47 [12] years) were included in the study; all patients completed the 24 weeks of study treatment. Twelve weeks after randomization, 6 patients in the amlodipine group had their dose doubled to 10 mg due to inadequate BP control. Mean BP reductions at study end were not significantly different between the barnidipine and amlodipine groups (office BP, -10.3/-9.4 vs -16.6/-9.1 mm Hg; ambulatory BP, 9.4/6.4 vs 8.1/5.1 mm Hg). Reductions in LVMI and markers of cardiac damage were not significantly different between the 2 groups. Significantly more patients in the amlodipine group reported drug-related AEs compared with those in the barnidipine group (9 [60%] vs 2 [13%]; P < 0.05). CONCLUSION: In this small sample of treatment-naive hypertensive patients, the antihypertensive effect of barnidipine 10 mg once daily was not significantly different from that of amlodipine 5 to 10 mg once daily.