Publications by authors named "Francois Regoli"

86 Publications

Temporal trends and long term follow-up of implantable cardioverter defibrillator therapy for secondary prevention: A 15-year single-centre experience.

Int J Cardiol 2017 Feb 10;228:31-36. Epub 2016 Nov 10.

Cardiocentro Ticino, Lugano, Switzerland.

Background: The aim of this study was to determine overall and aetiology-related incidence of secondary prevention ICD implantation over the last 15years in Canton Ticino and to assess clinical outcome according to time period of implantation.

Methods And Results: Consecutive patients treated by implantation of an ICD for secondary prevention from 2000 to 2015 were included in the current study and compared between 5-year cohorts (2000/2004; 2005/2009; 2010/2015). Yearly implantation rate, changing in clinical presentation over years and events during follow-up were evaluated. One-hundred fifty six patients were included. ICD implantation rate increased from 2.1 in 2000-2005 to 5.1 in 2010-2015, respectively (p 0.001). There was an increase in the proportion of non-ischaemic patients and of ventricular tachycardia (VT) as presenting rhythm. No differences in appropriate ICD interventions were observed according to aetiology, presenting arrhythmia or type of device. Reverse remodelling was observed more often in non-ischaemic patients, without any influence on the occurrence of appropriate interventions. Previous myocardial infarction (MI), atrial fibrillation (AF), NYHA class 2-3 and left ventricular ejection fraction (LVEF)<35% were predictors of appropriate therapies during follow-up.

Conclusions: Rate of implants for secondary prevention indication has almost doubled during the last 15years. Importantly, there has been a progressive increase of non-ischaemic patients receiving an ICD, and of VT as presenting rhythm. Patients had an overall good survival and a relatively low incidence of appropriate therapies. Improvement of ejection fraction did not correlate with risk reduction of ventricular arrhythmias.
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http://dx.doi.org/10.1016/j.ijcard.2016.11.071DOI Listing
February 2017

Usefulness of P-Wave Duration and Morphologic Variability to Identify Patients Prone to Paroxysmal Atrial Fibrillation.

Am J Cardiol 2017 Jan 8;119(2):275-279. Epub 2016 Oct 8.

Cardiocentro Ticino, Lugano, Switzerland.

Few data are available on the assessment of P-wave beat-to-beat morphology variability and its ability to identify patients prone to paroxysmal atrial fibrillation (AF) occurrence. Aim of this study was to determine whether electrocardiographic (ECG) parameters resulting from the beat-to-beat analysis of P wave in ECG recorded during sinus rhythm could be indicators of paroxysmal AF susceptibility. ECGs of 76 consecutive patients including 36 patients with history of AF and no overt structural cardiac abnormalities and a control group of 40 healthy patients without history of AF were analyzed. After preprocessing, features based on P waves and RR intervals were extracted from lead II of a 5-minute ECG recorded during sinus rhythm. The discriminative power of the extracted features was assessed. Among extracted features, the most discriminative ones to identify patients with paroxysmal episodes of AF were the mean P-wave duration and the SD of beat-to-beat Euclidean distance between P waves (an indicator of beat-to-beat P-wave morphologic variability). Patients with history of AF presented a significantly longer P-wave duration (125 ± 18 vs 110 ± 8 ms, p <0.001) and higher variability of P-wave morphology over time (beat-to-beat Euclidean distance: 0.11 ± 0.07 vs 0.076 ± 0.02, p <0.01) compared to patients without history of AF. Combination of P-wave duration and standard deviation of beat-to-beat Euclidean distance led to an accuracy of 88% in the discrimination between the 2 groups of patients. In conclusion, combination of P-wave duration and beat-to-beat Euclidean distance between P waves efficiently discriminates patients with history of AF and no overt structural cardiac abnormalities from healthy age-matched subjects, and it might be used as an effective tool to identify patients prone to paroxysmal AF occurrence.
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http://dx.doi.org/10.1016/j.amjcard.2016.09.043DOI Listing
January 2017

Comparative performance assessment of commercially available automatic external defibrillators: A simulation and real-life measurement study of hands-off time.

Resuscitation 2017 01 22;110:12-17. Epub 2016 Oct 22.

Fondazione Ticino Cuore, Breganzona, Switzerland; Division of Cardiology, Fondazione Cardiocentro Ticino, Lugano, Switzerland.

Purpose: Early and good quality cardiopulmonary resuscitation (CPR) and the use of automated external defibrillators (AEDs) improve cardiac arrest patients' survival. However, AED peri- and post-shock/analysis pauses may reduce CPR effectiveness.

Methods: The time performance of 12 different commercially available AEDs was tested in a manikin based scenario; then the AEDs recordings from the same tested models following the clinical use both in Pavia and Ticino were analyzed to evaluate the post-shock and post-analysis time.

Results: None of the AEDs was able to complete the analysis and to charge the capacitors in less than 10s and the mean post-shock pause was 6.7±2.4s. For non-shockable rhythms, the mean analysis time was 10.3±2s and the mean post-analysis time was 6.2±2.2s. We analyzed 154 AED records [104 by Emergency Medical Service (EMS) rescuers; 50 by lay rescuers]. EMS rescuers were faster in resuming CPR than lay rescuers [5.3s (95%CI 5-5.7) vs 8.6s (95%CI 7.3-10).

Conclusions: AEDs showed different performances that may reduce CPR quality mostly for those rescuers following AED instructions. Both technological improvements and better lay rescuers training might be needed.
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http://dx.doi.org/10.1016/j.resuscitation.2016.10.006DOI Listing
January 2017

Brugada Syndrome and Early Repolarisation: Distinct Clinical Entities or Different Phenotypes of the Same Genetic Disease?

Arrhythm Electrophysiol Rev 2016 Aug;5(2):84-9

Cardiocentro Ticino, Lugano, Switzerland.

Brugada and early repolarisation (ER) syndromes are currently considered two distinct inherited electrical disorders with overlapping clinical and electrocardiographic features. A considerable number of patients diagnosed with ER syndrome have a genetic mutation related to Brugada syndrome (BrS). Due to the high variable phenotypic manifestation, patients with BrS may present with inferolateral repolarisation abnormalities only, resembling the ER pattern. Moreover, the complex genotype-phenotype interaction in BrS can lead to the occurrence of mixed phenotypes with ER syndrome. The first part of this review focuses on specific clinical and electrocardiographic features of BrS and ER syndrome, highlighting the similarity shared by the two primary electrical disorders. The genetic background, with emphasis on the complexity of genotype-phenotype interaction, is explored in the second part of this review.
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http://dx.doi.org/10.15420/AER.2016.23.2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5016597PMC
August 2016

High recurrence of device-related adverse events following transvenous lead extraction procedure in patients with cardiac resynchronization devices.

Eur J Heart Fail 2016 Oct 12;18(10):1270-1277. Epub 2016 May 12.

Fondazione Cardiocentro Ticino, Department of Cardiology, Lugano, Switzerland.

Introduction: Little is known about the clinical outcome and recurring system-related adverse events (SAE) in cardiac resynchronization therapy (CRT) patients after transvenous lead extraction (TLE).

Methods And Results: From January 2009 to June 2014, 256 consecutive CRT patients (mean age 68.3 ± 11.6 years, 216 male, 88% in New York Heart Association class II-IV, ejection fraction 35.1 ± 10.8%) were treated at four European institutions with TLE. Indications for TLE included systemic (18%) or local (45%) infection, system malfunction (34%), or other (3%). Demographic, clinical, TLE procedural, and follow-up data were collected retrospectively. Adverse events (AE) were considered as death from any cause, cardiovascular hospitalization, and SAE (SAE included pocket and/or systemic infection, lead malfunction, or pocket haematoma requiring revision). Complete removal was achieved for 609 out of 614 leads (99.2%) by using either manual traction (28%), mechanical (52%) or laser (20%) sheaths. Over a median follow-up of 21 (interquartile range 12-29) months, cumulative incidences of any AE and SAE were 53.9% and 21.1%, respectively. Recurring system malfunction occurred in 23 patients (9.0%), infection in 16 patients (6.2%), and pocket haematoma requiring revision in 15 patients (5.9%). Oral anticoagulation therapy was an independent predictor of both any AE [hazard ratio (HR) 2.09, 95% confidence interval (CI) 1.35-3.22, P = 0.001] and SAE (HR 2.38, 95% CI 1.21-4.68, P = 0.012) after TLE.

Conclusions: Even though TLE is safe and effective to treat CRT patients, a high burden of recurring SAE after TLE was observed at mid-term follow-up. Careful evaluation of both patient characteristics as well as implantation strategy is suggested when indicating TLE in a CRT patient, particularly in patients receiving oral anticoagulation therapy.
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http://dx.doi.org/10.1002/ejhf.558DOI Listing
October 2016

Combined Left Atrial Appendage Closure and Pacemaker Implant through a Single Right Femoral Vein Access.

Pacing Clin Electrophysiol 2016 Aug 13;39(8):900-2. Epub 2016 Apr 13.

Cardiology Department, Fondazione Cardiocentro Ticino, Lugano, Switzerland.

Left atrial appendage (LAA) closure is indicated in patients with atrial fibrillation (AF) and high bleeding as well as thromboembolic risks. A subgroup of these patients may also present an indication for a single-chamber permanent pacemaker due to symptomatic low-rate AF or when "ablate and pace" strategy is indicated for rate control. A miniaturized wireless transcatheter pacing system (TPS) is now available as a single-chamber permanent pacemaker. This case presents how combined LAA closure and permanent pacemaker implant, by means of TPS, is feasible through a single femoral venous access.
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http://dx.doi.org/10.1111/pace.12849DOI Listing
August 2016

An in-silico analysis of the effect of heart position and orientation on the ECG morphology and vectorcardiogram parameters in patients with heart failure and intraventricular conduction defects.

J Electrocardiol 2015 Jul-Aug;48(4):617-25. Epub 2015 May 8.

Center for Computational Medicine in Cardiology, Institute of Computational Science, Università della Svizzera italiana, Lugano, Switzerland; Division of Cardiology, Fondazione Cardiocentro Ticino, Lugano, Switzerland.

Aim: The aim of this study was to investigate the influence of geometrical factors on the ECG morphology and vectorcardiogram (VCG) parameters.

Methods: Patient-tailored models based on five heart-failure patients with intraventricular conduction defects (IVCDs) were created. The heart was shifted up to 6 cm to the left, right, up, and down and rotated ±30° around the anteroposterior axis. Precordial electrodes were shifted 3 cm down.

Results: Geometry modifications strongly altered ECG notching/slurring and intrinsicoid deflection time. Maximum VCG parameter changes were small for QRS duration (-6% to +10%) and QRS-T angle (-6% to +3%), but considerable for QRS amplitude (-36% to +59%), QRS area (-37% to +42%), T-wave amplitude (-41% to +36%), and T-wave area (-42% to +33%).

Conclusion: The position of the heart with respect to the electrodes is an important factor determining notching/slurring and voltage-dependent parameters and therefore must be considered for accurate diagnosis of IVCDs.
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http://dx.doi.org/10.1016/j.jelectrocard.2015.05.004DOI Listing
March 2016

In vivo electromechanical assessment of heart failure patients with prolonged QRS duration.

Heart Rhythm 2015 Jun 5;12(6):1259-67. Epub 2015 Mar 5.

Center for Computational Medicine in Cardiology, Institute of Computational Science, University of Lugano, Lugano, Switzerland; Division of Cardiology, Fondazione Cardiocentro Ticino, Lugano, Switzerland. Electronic address:

Background: Combined measurement of electrical activation and mechanical dyssynchrony in heart failure (HF) patients is scarce but may contain important mechanistic and diagnostic clues.

Objective: The purpose of this study was to characterize the electromechanical (EM) coupling in HF patients with prolonged QRS duration.

Methods: Ten patients with QRS width >120 ms underwent left ventricular (LV) electroanatomic contact mapping using the Noga® XP system (Biosense Webster). Recorded voltages during the cardiac cycle were converted to maps of depolarization time (TD). Electrode positions were tracked and converted into maps of time-to-peak shortening (TPS) using custom-made deformation analysis software. Correlation analysis was performed between the 2 maps to quantify EM coupling. Simulations with the CircAdapt cardiovascular system model were performed to mechanistically unravel the observed relation between TD and TPS.

Results: The delay between earliest LV electrical activation and peak shortening differed considerably between patients (TPSmin-TDmin = 360 ± 73 ms). On average, total mechanical dyssynchrony exceeded total electrical activation (ΔTPS = 177 ± 47 ms vs ΔTD = 93 ± 24 ms, P <.001), but a large interpatient variability was observed. The TD and TPS maps correlated strongly in all patients (median R = 0.87, P <.001). These correlations were similar for regions with unipolar voltages above and below 6mV (Mann-Whitney U test, P = .93). Computer simulations revealed that increased passive myocardial stiffness decreases ΔTPS relative to ΔTD and that lower contractility predominantly increases TPSmin-TDmin.

Conclusion: EM coupling in HF patients is maintained, but the relationship between TD and TPS differs strongly between patients. Intra-individual and inter-individual differences may be explained by local and global differences in passive and contractile myocardial properties.
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http://dx.doi.org/10.1016/j.hrthm.2015.03.006DOI Listing
June 2015

Patient-specific modelling of cardiac electrophysiology in heart-failure patients.

Europace 2014 Nov;16 Suppl 4:iv56-iv61

Center for Computational Medicine in Cardiology, Faculty of Informatics, Università della Svizzera italiana, Via Giuseppe Buffi 13, 6904 Lugano, Switzerland Division of Cardiology, Fondazione Cardiocentro Ticino, 6904 Lugano, Switzerland.

Aims: Left-ventricular (LV) conduction disturbances are common in heart-failure patients and a left bundle-branch block (LBBB) electrocardiogram (ECG) type is often seen. The precise cause of this pattern is uncertain and is probably variable between patients, ranging from proximal interruption of the left bundle branch to diffuse distal conduction disease in the working myocardium. Using realistic numerical simulation methods and patient-tailored model anatomies, we investigated different hypotheses to explain the observed activation order on the LV endocardium, electrogram morphologies, and ECG features in two patients with heart failure and LBBB ECG.

Methods And Results: Ventricular electrical activity was simulated using reaction-diffusion models with patient-specific anatomies. From the simulated action potentials, ECGs and cardiac electrograms were computed by solving the bidomain equation. Model parameters such as earliest activation sites, tissue conductivity, and densities of ionic currents were tuned to reproduce the measured signals. Electrocardiogram morphology and activation order could be matched simultaneously. Local electrograms matched well at some sites, but overall the measured waveforms had deeper S-waves than the simulated waveforms.

Conclusion: Tuning a reaction-diffusion model of the human heart to reproduce measured ECGs and electrograms is feasible and may provide insights in individual disease characteristics that cannot be obtained by other means.
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http://dx.doi.org/10.1093/europace/euu257DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4217520PMC
November 2014

Clinical utility of routine use of continuous transesophageal echocardiography monitoring during transvenous lead extraction procedure.

Heart Rhythm 2015 Feb 13;12(2):313-20. Epub 2014 Oct 13.

Fondazione Cardiocentro Ticino, Lugano, Switzerland.

Background: Data on the use of transesophageal echocardiography (TEE) during transvenous lead extraction (TLE) procedures are scarce.

Objective: The purpose of this study was to assess the routine use of TEE during transvenous lead extraction.

Methods: From January 2009 to January 2014, TLE of 241 leads in 168 patients (mean age 70 ± 13 years, 129 male, left ventricular ejection fraction 37% ± 13%) was performed. Indication for TLE was lead dysfunction (56.5%), upgrade (27.0%), infection (13%), or other (3.1%). TLE techniques combined a mechanical approach amended by laser technique if required. Extraction procedures were performed with patients under general anesthesia with continuous invasive arterial blood pressure and TEE monitoring.

Results: TEE was possible in all except 1 patient. TEE images in different projections were acquired and stored before and immediately after extraction of each lead. TLE was complete for 236 of 241 leads (97.9%); 4 distal lead tips (1.7%) remained in situ, and 1 dual-coil implantable cardioverter-defibrillator electrode (0.4%) could not be removed. New TEE findings after TLE were observed in 7 of 161 cases (4.3%): pericardial effusion (mild in 4 [2.5%] and severe in 1 [0.6%]) and worsening of tricuspid valve insufficiency (2 patients [1.2%]). The only case of severe pericardial effusion occurred after laceration of the superior vena cava, which required immediate rescue surgery (0.6%, confidence interval 0.01-3.3). In all other cases, TEE findings did not entail immediate diagnostic or therapeutic measures.

Conclusion: New TEE findings produced during TLE necessitating immediate therapeutic measures occurred in only 0.6% of cases, suggesting the limited utility of routine continuous TEE monitoring during TLE.
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http://dx.doi.org/10.1016/j.hrthm.2014.10.013DOI Listing
February 2015

Biological markers to predict cardiac resynchronization therapy effect.

Circ J 2014 6;78(9):2154-6. Epub 2014 Aug 6.

Fondazione Cardiocentro Ticino.

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http://dx.doi.org/10.1253/circj.cj-14-0771DOI Listing
May 2015

Feasibility, safety, and short-term outcome of leadless ultrasound-based endocardial left ventricular resynchronization in heart failure patients: results of the wireless stimulation endocardially for CRT (WiSE-CRT) study.

Europace 2014 May 4;16(5):681-8. Epub 2014 Feb 4.

Division of Cardiology, Fondazione Cardiocentro Ticino, Via Tesserete 48, CH-6900 Lugano, Switzerland.

Aims: Left ventricular (LV) endocardial pacing may address the limitations in the selection of an LV pacing site and provide improvements in cardiac resynchronization therapy (CRT) effectiveness. We report on the feasibility, the safety, and the short-term outcome of a leadless ultrasound-based technology for LV endocardial resynchronization in heart failure (HF) patients enroled into the Wireless Stimulation Endocardially for CRT (WiSE-CRT) study.

Methods And Results: Seventeen HF patients were enroled and categorized as: (i) patients in whom attempted coronary sinus lead implantation for CRT had failed (n = 7); (ii) patients with a previously implanted CRT device, not responding to CRT (n = 2); and (iii) patients with previously implanted pacemakers or implantable cardioverter-defibrillator and meeting the standard indications for CRT (n = 8). System implantation was achieved in 13 patients (76.5%); mean R-wave amplitude was 5.6 ± 3.2 mV and the mean pacing threshold was 1.6 ± 1.0 V, respectively. In one patient, no sufficient pacing thresholds were found; in three patients pericardial effusion occurred. Biventricular pacing was recorded in 83% and 92% of the patients at 1 month and 6 months, respectively. QRS duration was shorter during biventricular pacing compared with right ventricular pacing at 1 month (-41 ms; P = 0.0002) and 6 months (-42 ms; P = 0.0011), respectively. At the 6-month follow-up, two-thirds of the patients had at least one functional class change. Left ventricular ejection fraction significantly increased (P < 0.01) by 6 points at the 6-month follow-up.

Conclusion: The feasibility of providing an endocardial stimulation for CRT with a leadless technology was successfully demonstrated. Despite the promising results for a novel technology, further study is required to definitively conclude the safety and the performance of the system.

Clinical Trial Registration Information: NCT01294527.
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http://dx.doi.org/10.1093/europace/eut435DOI Listing
May 2014

Adrenergic receptor gene polymorphism and left ventricular reverse remodelling after cardiac resynchronization therapy: preliminary results.

Europace 2013 Oct 31;15(10):1475-81. Epub 2013 May 31.

Cardiology, Department of Medical and Surgical Specialties, Radiological Sciences, and Public Health, University and Civil Hospital of Brescia, Piazzale Spedali Civili 1, 25123 Brescia, Italy.

Aims: Several factors can influence the extent of left ventricular (LV) reverse remodelling after cardiac resynchronization therapy (CRT) in patients with heart failure (HF). Polymorphism in genes involved in cardiac remodelling, namely beta-adrenergic receptors (ARs), may have a role. We studied the influence of beta-1 Arg389Gly, beta-2 Arg16Gly, and beta-2 Gln27Glu ARs gene polymorphisms on the magnitude of reverse remodelling response to CRT and its possible correlations with the incidence of appropriate implantable cardioverter-defibrillator (ICD) shocks.

Methods And Results: Beta-ARs were assessed in 101 patients with HF due to idiopathic (50.5%) or ischaemic (49.5%) dilated cardiomyopathy, undergoing CRT for standard indications [left ventricular ejection fraction (LVEF) 23.5 ± 7.5%, QRS ≥ 120 ms]. Left ventricular ejection fraction was measured by echocardiography at baseline, 6 months after CRT, and periodically afterwards. The LVEF change from baseline was of 3.1 ± 11 units among Gln27Gln, 8.3 ± 10.4 units among Gln27Glu, 11 ± 6.4 units among Glu27Glu carriers (P = 0.018 for Gln27Gln vs. Glu27Glu carriers), and 8.8 ± 9.8 units among Gln27Glu + Glu27Glu carriers (P = 0.006 vs. Gln27Gln). Gln27 homozygotes had a higher incidence of appropriate ICD shocks for fast ventricular tachycardia/ventricular fibrillation.

Conclusion: Beta-2 Gln27Glu ARs gene polymorphism may influence LV reverse remodelling after CRT with Glu27Glu carriers showing the greatest improvement. It may also influence the incidence of malignant ventricular tachyarrhythmias.
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http://dx.doi.org/10.1093/europace/eut136DOI Listing
October 2013

First-in-man implantation of leadless ultrasound-based cardiac stimulation pacing system: novel endocardial left ventricular resynchronization therapy in heart failure patients.

Europace 2013 Aug 23;15(8):1191-7. Epub 2013 May 23.

Division of Cardiology, Fondazione Cardiocentro Ticino, Via Tesserete 48, CH-6900 Lugano, Switzerland.

Aims: The importance of specific-site pacing is increasingly recognized in cardiac resynchronization therapy (CRT). Using current pacing technology, site selection is still largely limited by coronary vein anatomy, whereas left ventricular (LV) endocardial pacing using current lead technology is risky and challenging. To overcome limitations and complications with current LV pacing, the feasibility of a new technology enabling LV endocardial stimulation without the use of a lead is being evaluated in patients.

Methods And Results: Patients presented in this report are part of the Wireless Stimulation Endocardially for CRT Trial (WiSE-CRT) study investigating the safety and performance of the WiCS(®)-LV system, an implantable cardiac pacing system capable of leadless pacing based on converting ultrasound energy to electrical energy. Three patients are presented: (i) a patient with an existing implantable defibrillator, (ii) a patient with a CRT system whose LV lead does not capture, and (iii) a CRT patient classified as a non-responder. All three patients were successfully treated. Acute electrical pacing thresholds ranged from 0.7 to 1.0 V at 0.5 ms; all patients retained captured at 6 months. Functional New York Heart Association class significantly changed (Pre: III in two patients, and IV in one patient; Post: I in one patient, II in one patient, and II-III in one patient), and LV ejection fraction increased from 23.7 ± 3.4% to 39 ± 6.2% (P < 0.017).

Conclusion: This report on three first-in-man cases shows that leadless endocardial pacing may be safely applied and effective, conferring short- to-mid-term symptomatic benefits. These promising findings are yet to be substantiated by larger ongoing studies.

Clinical Trial Registration Information: http://clinicaltrials.gov/ct2/show/NCT01294527.
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http://dx.doi.org/10.1093/europace/eut124DOI Listing
August 2013

Validation of Seattle Heart Failure Model for mortality risk prediction in patients treated with cardiac resynchronization therapy.

Eur J Heart Fail 2013 Feb 30;15(2):211-20. Epub 2012 Oct 30.

Division of Cardiology, Fondazione Cardiocentro Ticino, Via Tesserete 48, CH-6900 Lugano, Switzerland.

Aims: Survival prediction by the Seattle Heart Failure Model (SHFM) of patients treated with cardiac resynchronization therapy (CRT) remains ill defined. The performance of the SHFM in this clinical setting was therefore evaluated.

Methods And Results: Data from 1309 consecutive CRT patients (five centres) were collected retrospectively; 1139 of these patients were considered for analysis. Three-hundred and seven deaths occurred over 40.1 months (interquartile range 25.2-60.0 months; mean event rate 9.7%/year; survival of 89, 81, and 64% at 1, 2, and 5 years). Kaplan-Meier event-free survival analysis stratified according to tertile of SHFM score was significant (log rank test P < 0.001). High-risk tertile (T1) survival was 82, 67, and 46% at 1, 2, and 5 years, respectively. Observed compared with SHFM-predicted survival was 0.11 vs. 0.08, 0.19 vs. 0.16, and 0.36 vs. 0.36, at 1, 2, and 5 years. Model discrimination by c-statistic was 0.64; the logistic models' area under the receiver operating characteristic curve (AUC-ROC) of risk tertiles was 0.66, 0.68, and 0.67, at 1, 2, and 5 years. Compared with the other two groups, T1 was globally more compromised. Within the T1 group, independent predictors of death were male gender, ischaemic heart failure aetiology, lower body weight, and CRT pacemaker.

Conclusions: SHFM performance was found to be modest, tending to overestimate survival. However, SHFM identified a high-risk, globally more compromised patient subgroup, hence supporting a comprehensive approach, which should include nutritional, metabolic, and immunological aspects, as well as defibrillator back-up.
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http://dx.doi.org/10.1093/eurjhf/hfs162DOI Listing
February 2013

Cardiac resynchronization therapy. Indications and contraindications.

Rev Esp Cardiol (Engl Ed) 2012 Sep 12;65(9):843-9. Epub 2012 Jul 12.

Divisione di Cardiologia, Fondazione Cardiocentro Ticino, Lugano, Switzerland.

Progress in medical therapy wouldn't be possible without the contribution of the scientific community. Several randomized controlled trials have led to our current guidelines. Specifically, COMPANION and CARE-HF trials involved a turning point for cardiac resynchronization therapy, which became well recognized for the treatment of heart failure patients with QRS≥120ms, ejection fraction≤35%, and sinus rhythm to reduce hospitalizations and all-cause mortality. New indications were then established for atrial fibrillation, pacemaker-dependent, and mildly symptomatic patients, but new challenges should be addressed, namely reducing complication and nonresponder rates. To achieve this, further studies and new implant techniques are under investigation.
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http://dx.doi.org/10.1016/j.recesp.2012.02.027DOI Listing
September 2012

Anatomy of pulmonary veins by real-time 3D TEE: implications for catheter-based pulmonary vein ablation.

JACC Cardiovasc Imaging 2012 Apr;5(4):456-62

Division of Cardiology, Fondazione Cardiocentro Ticino, Lugano, Switzerland.

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http://dx.doi.org/10.1016/j.jcmg.2011.10.009DOI Listing
April 2012

Electrical and mechanical ventricular activation during left bundle branch block and resynchronization.

J Cardiovasc Transl Res 2012 Apr 7;5(2):117-26. Epub 2012 Feb 7.

Department of Physiology, Cardiovascular Research Institute Maastricht, Maastricht University, Maastricht 6200 MD, The Netherlands.

Cardiac resynchronization therapy (CRT) aims to treat selected heart failure patients suffering from conduction abnormalities with left bundle branch block (LBBB) as the culprit disease. LBBB remained largely underinvestigated until it became apparent that the amount of response to CRT was heterogeneous and that the therapy and underlying pathology were thus incompletely understood. In this review, current knowledge concerning activation in LBBB and during biventricular pacing will be explored and applied to current CRT practice, highlighting novel ways to better measure and treat the electrical substrate.
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http://dx.doi.org/10.1007/s12265-012-9351-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3294208PMC
April 2012

Value of real-time transesophageal 3-dimensional echocardiography in guiding ablation of isthmus-dependent atrial flutter and pulmonary vein isolation.

Circ J 2012 6;76(1):5-14. Epub 2011 Oct 6.

Division of Cardiology, Fondazione Cardiocentro Ticino, Lugano, Switzerland.

In the past decade, both the range of indications and the efficacy and safety of interventional electrophysiology has improved considerably. This progress is attributed to both the accumulating experience of electrophysiologists and the advances in technological tools facilitating the diagnosis and treatment of cardiac arrhythmias. Real-time 3-dimensional transesophageal echocardiography (RT 3D TEE) has emerged as a new imaging tool in the clinical arena. Its ability to image in "real time" cardiac structures "en face" and the almost entire length of intracardiac catheters has made this technique a promising imaging tool to guide percutaneous catheter-based procedures. More recently it has been used in monitoring ablation procedures. In this review, the advantages and current limitations of RT 3D TEE during ablation of cavotricuspid isthmus-dependent atrial flutter and pulmonary vein isolation are described.
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http://dx.doi.org/10.1253/circj.cj-11-1040DOI Listing
July 2012

Feasibility and acute efficacy of radiofrequency ablation of cavotricuspid isthmus-dependent atrial flutter guided by real-time 3D TEE.

JACC Cardiovasc Imaging 2011 Jul;4(7):716-26

Division of Cardiology, Fondazione Cardiocentro Ticino, Lugano, Switzerland.

Objectives: The aim of this study was to evaluate the feasibility and acute efficacy of real-time 3-dimensional transesophageal echocardiography (RT3DTEE)-guided ablation of the cavotricuspid isthmus (CVTI).

Background: The use of RT3DTEE to guide a transcatheter radiofrequency ablation procedure has never been systematically investigated.

Methods: Seventy consecutive patients with CVTI-dependent atrial flutter underwent CVTI ablation. Procedural monitoring using RT3DTEE was assigned to patients who requested general anesthesia for the procedure (n = 21 [30%]). In the other 49 patients (the control group), the procedures were monitored using the standard fluoroscopic approach. Procedural time was considered as skin-to-skin electrophysiological procedure duration, not including anesthesia preparation; adequate radiofrequency ablation applications (with fixed temperature and power settings) were considered as lesions lasting ≥ 60 s.

Results: RT3DTEE allowed visualization of the CVTI and identified related structures in most patients (20 of 21); anatomic features such as long CVTI (n = 11), prominent Eustachian ridge (n = 9), prominent Eustachian valve (n = 6), septal recess (n = 8), and pectinate muscles (n = 10) were frequent. Also, RT3DTEE allowed continuous visualization of ablation catheter movement and contact. Compared with the control group, RT3DTEE was equally effective in achieving CVTI bidirectional block (100% in both groups), and no complications occurred. RT3DTEE shortened procedural time (median 73.0 min, interquartile range [IQR] 60.0 to 90.0 min, vs. median 115.0 min, IQR 85.0 to 133.0 min, p < 0.001), reduced radiation exposure (median fluoroscopy time 4.2 min, IQR 3.1 to 8.4 min, vs. median 19.3 min, IQR 12.9 to 36.4 min, p < 0.001; median fluoroscopy dose 575.4 cGy · cm(2), IQR 428.5 to 1,299.4 cGy · cm(2), vs. median 3,520.7 cGy · cm(2), IQR 1,700.0 to 6,709.0 cGy · cm(2), p < 0.001), and reduced the number of radiofrequency applications to achieve bidirectional block (median 7, IQR 6 to 10, vs. median 12, IQR 10 to 22, p = 0.007). A strong learning curve was detected by comparing procedural data between the first and last patients treated using RT3DTEE.

Conclusions: RT3DTEE-guided ablation of CVTI was feasible, allowing real-time detailed morphological CVTI characterization as well as continuous visualization of the ablation catheter during radiofrequency ablation. This approach entailed marked reductions in procedural time, radiation exposure, and the number of radiofrequency applications.
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http://dx.doi.org/10.1016/j.jcmg.2011.03.018DOI Listing
July 2011

Evaluation of the left atrial appendage with real-time 3-dimensional transesophageal echocardiography: implications for catheter-based left atrial appendage closure.

Circ Cardiovasc Imaging 2011 Sep 7;4(5):514-23. Epub 2011 Jul 7.

Division of Cardiology, Fondazione Cardiocentro Ticino, Lugano, Switzerland.

Background: Precise knowledge of left atrial appendage (LAA) orifice size is crucial for correct sizing of LAA closure devices. The aim of the present study was to determine the performance of real-time 3D transesophageal echocardiography (RT3DTEE) for LAA orifice size assessment, compared with 2D transesophageal echocardiography (2DTEE), and to investigate the impact of atrial fibrillation (AF) on LAA orifice size.

Methods And Results: One hundred thirty-seven patients (38 control subjects, 31 with paroxysmal AF, 38 with persistent AF and 30 with permanent AF) underwent 2DTEE and RT3DTEE. Both techniques were used to measure LAA orifice area. Clinically-indicated 64-slice computed tomography (CT) was used as reference technique in 46 patients. Two-dimensional TEE underestimated LAA orifice area, compared with RT3DTEE (1.99±0.94 cm(2) versus 3.05±1.27 cm(2); P<0.001). RT3DTEE showed higher correlation with CT for the assessment of LAA orifice area, compared with 2DTEE (r=0.92; 95% confidence interval, 0.85 to 0.95, versus r=0.72; 95% confidence interval, 0.54 to 0.83, respectively). At Bland-Altman analysis, RT3DTEE and 2DTEE underestimated LAA orifice area, compared with CT. However, RT3DTEE showed smaller bias (0.07 cm(2) versus 0.72 cm(2)) and narrower limits of agreement (-0.71 to 0.85 cm(2) versus -0.58 to 2.02 cm(2)) with CT, compared with 2DTEE. Among AF patients, a progressive increase in RT3DTEE-derived LAA orifice area was observed with increasing frequency of AF (P<0.001). At multivariate analysis, AF and left atrial volume index (P<0.001 for both) were independently associated with RT3DTEE-derived LAA orifice area.

Conclusions: RT3DTEE is more accurate than 2DTEE for the assessment of LAA orifice size. A progressive increase in LAA orifice area is observed with increasing frequency of AF.
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http://dx.doi.org/10.1161/CIRCIMAGING.111.963892DOI Listing
September 2011

Impact of cardiac resynchronization therapy on the severity of mitral regurgitation.

Europace 2011 Jun 12;13(6):829-38. Epub 2011 Apr 12.

Texas Cardiac Arrhythmia Institute at St David's Medical Center, Austin, TX, USA.

Aims: Functional mitral regurgitation (MR) could be managed by both cardiac resynchronization therapy (CRT) and mitral-valve surgery. Clinical decision making regarding the appropriateness of mitral-valve surgery vs. CRT is a challenging task. This study assessed the prevalence and prognosis of various degrees of functional MR in CRT candidates. Additionally, we sought to identify functional MR patients who either can be adequately managed by CRT only or will need surgery.

Methods And Results: Cardiac resynchronization therapy recipients (n= 794) were followed-up for 26 ± 18 months. Mitral regurgitation severity was quantified on scale 0-4. Cardiac resynchronization therapy responders were identified based on improvement in the New York Heart Association class and left-ventricular ejection fraction. Severity of MR and LV reverse remodelling were assessed at 3 and 12 months. Predictors of long-term MR change and CRT response were explored with multivariable models. Mitral regurgitation was present in 86%, with 35% prevalence of advanced MR (grade 3-4). Improvement of MR ≥ 1° after 12 months occurred in 46% of patients. It was relatively more frequent in patients with advanced MR at baseline (63%, P< 0.01). Baseline MR severity and change in MR at 3-month follow-up predicted response to CRT. Patients with ≥ 1° MR improvement at 12 months had more reverse remodelling compared with those with no change or worsening of MR.

Conclusions: Mitral regurgitation improvement at 3 months predicts CRT response and MR improvement at 12-month follow-up. This finding could have implications for subsequent MR surgical therapies.
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http://dx.doi.org/10.1093/europace/eur047DOI Listing
June 2011

Real-time, fluoroless, anatomic-guided catheter navigation by 3D TEE during ablation procedures.

JACC Cardiovasc Imaging 2011 Feb;4(2):203-6

Division of Cardiology, Fondazione Cardiocentro Ticino, Lugano, Switzerland.

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http://dx.doi.org/10.1016/j.jcmg.2010.10.010DOI Listing
February 2011

Pulmonary vein isolation guided by real-time three-dimensional transesophageal echocardiography.

Pacing Clin Electrophysiol 2012 Mar 31;35(3):e76-9. Epub 2011 Jan 31.

Division of Cardiology, Fondazione Cardiocentro Ticino, Lugano, Switzerland.

The present case illustrates pulmonary vein isolation guided by real-time three-dimensional transesophageal echocardiography. This imaging modality allowed to navigate in a point-by-point fashion around pulmonary veins to assess both catheter location in relation to pulmonary vein ostia and stability of catheter tip. Also, it offered high-resolution visualization of a thickened, prominent tissue that surrounded the left upper pulmonary vein (the ligament of Marshall). The ability to visualize this anatomical structure along with intracardiac recording of electrical signals allowed to safely modulate in loco radiofrequency energy delivery, thus achieving electrical isolation of the pulmonary vein.
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http://dx.doi.org/10.1111/j.1540-8159.2011.03029.xDOI Listing
March 2012

Economic impact of remote patient monitoring: an integrated economic model derived from a meta-analysis of randomized controlled trials in heart failure.

Eur J Heart Fail 2011 Apr 29;13(4):450-9. Epub 2010 Dec 29.

Service of Biometry and Clinical Epidemiology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.

Aims: To assess the cost-effectiveness and the cost utility of remote patient monitoring (RPM) when compared with the usual care approach based upon differences in the number of hospitalizations, estimated from a meta-analysis of randomized clinical trials (RCTs).

Methods And Results: We reviewed the literature published between January 2000 and September 2009 on multidisciplinary heart failure (HF) management, either by usual care or RPM to retrieve the number of hospitalizations and length of stay (LOS) for HF and for any cause. We performed a meta-analysis of 21 RCTs (5715 patients). Remote patient monitoring was associated with a significantly lower number of hospitalizations for HF [incidence rate ratio (IRR): 0.77, 95% CI 0.65-0.91, P < 0.001] and for any cause (IRR: 0.87, 95% CI: 0.79-0.96, P = 0.003), while LOS was not different. Direct costs for hospitalization for HF were approximated by diagnosis-related group (DRG) tariffs in Europe and North America and were used to populate an economic model. The difference in costs between RPM and usual care ranged from €300 to €1000, favouring RPM. These cost savings combined with a quality-adjusted life years (QALYs) gain of 0.06 suggest that RPM is a 'dominant' technology over existing standard care. In a budget impact analysis, the adoption of an RPM strategy entailed a progressive and linear increase in costs saved.

Conclusions: The novel cost-effectiveness data coupled with the demonstrated clinical efficacy of RPM should encourage its acceptance amongst clinicians and its consideration by third-party payers. At the same time, the scientific community should acknowledge the lack of prospectively and uniformly collected economic data and should request that future studies incorporate economic analyses.
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http://dx.doi.org/10.1093/eurjhf/hfq232DOI Listing
April 2011

Past, present, and future of CRT.

Heart Fail Rev 2011 May;16(3):205-14

Division of Cardiology, Fondazione Cardiocentro Ticino, Via Tesserete 48, 6900 Lugano, Switzerland.

Cardiac resynchronization therapy is a key non-pharmacological treatment strategy for drug-refractory moderate-to-severe symptomatic heart failure in the presence of compromised left ventricular function and ventricular conduction delay. Because not all patients with conventional criteria benefit from CRT, continuous efforts have been directed toward improving patient selection; in particular, emerging echocardiographic criteria such as regional and global myocardial strains are being investigated to better predict CRT response. In the meantime, growing evidence from large randomized controlled trials (RCTs, REVERSE, and MADIT-CRT) has demonstrated that even mildly symptomatic patients may benefit from CRT. The role of CRT in heart failure patients with narrow QRS, however, remains to be defined in the scheme of larger RCTs (such as EchoCRT) as the ones carried out thus far (RethinQ and ESTEEM-CRT). Important experimental data derived from animal heart failure models are gradually elucidating the complex pathophysiological basis of cardiac dyssynchrony, which involves diffuse alterations from genome to structure. At the same time, technological breakthroughs, such as wireless endocardial cardiac pacing, will render the prospect of delivering CRT more precisely and more effectively, a reality in the near future.
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http://dx.doi.org/10.1007/s10741-010-9214-2DOI Listing
May 2011