Ciro Cavallaro

Rationale and design of the health economics evaluation registry for remote follow-up: TARIFF

Aims The aims of the study are to develop a cost-minimization analysis from the hospital perspective and a cost-effectiveness analysis from the third payer standpoint, based on direct estimates of costs and QOL associated with remote follow-ups, using Merlin@home and Merlin.net, compared with standard ambulatory follow-ups, in the management of ICD and CRT-D recipients. Methods and results Remote monitoring systems can replace ambulatory follow-ups, sparing human and economic resources, and increasing patient safety. TARIFF is a prospective, controlled, observational study aimed at measuring the direct and indirect costs and quality of life (QOL) of all participants by a 1-year economic evaluation. A detailed set of hospitalized and ambulatory healthcare costs and losses of productivity that could be directly influenced by the different means of follow-ups will be collected. The study consists of two phases, each including 100 patients, to measure the economic resources consumed during the first phase, associated with standard ambulatory follow-ups, vs. the second phase, associated with remote follow-ups. Conclusion Remote monitoring systems enable caregivers to better ensure patient safety and the healthcare to limit costs. TARIFF will allow defining the economic value of remote ICD follow-ups for Italian hospitals, third payers, and patients. The TARIFF study, based on a cost-minimization analysis, directly comparing remote follow-up with standard ambulatory visits, will validate the cost effectiveness of the Merlin.net technology, and define a proper reimbursement schedule applicable for the Italian healthcare system. Trial registration: NCT01075516.

Flecainide single oral dose for management of paroxysmal supraventricular tachycardia in children and young adults

The efficacy of a single oral dose of flecainide to terminate paroxysmal supraventricular tachycardia (PSVT) was evaluated in 25 children and young adults. The subjects were selected from a group of 35 patients with recurrent attacks of PSVT evaluated by means of electrophysiologic study and intravenous electropharmacologic testing with flecainide. In all 25 patients the induced PSVT was stopped by intravenous flecainide and was then no longer inducible or nonsustained. All patients had normal hearts. At least 48 hours after acute intravenous testing, 25 patients underwent electrophysiologic study with a transesophageal catheter and PSVT was induced in all of them: atrioventricular reentrant tachycardia in 16 and atrioventricular nodal reentrant tachycardia in nine. During stable tachycardia, a single oral dose of flecainide (2.9 +/- 0.3 mg/kg; 2.5 to 3.3 mg/kg) was administered. This approach was effective for termination of PSVT in 22 patients. The mean plasma level of flecainide at cessation of tachycardia was 277 +/- 92 ng/ml (150 to 500 mg/ml). All 22 patients who responded were given a single oral dose of flecainide for recurrences of PSVT during follow-up. During a period of 12 +/- 7 months (2 to 27 months) a total of 134 spontaneous episodes of PSVT were reported, and 127 of these episodes were terminated with periodic management. Thus oral periodic flecainide seems useful for management of PSVT in selected patients.

Feasibility and efficacy of electrical cardioversion after cardiac resynchronization implantation in patients with permanent atrial fibrillation

PurposePatients with permanent atrial fibrillation (AF) who undergo cardiac resynchronization therapy (CRT) may spontaneously recover sinus rhythm during follow-up. We tested the feasibility and efficacy of electrical cardioversion attempted after 3xa0months of CRT in patients with permanent AF and measured the long-term maintenance of sinus rhythm.MethodsTwenty-eight consecutive patients with permanent AF in whom CRT defibrillators had been implanted were scheduled for internal electrical cardioversion after 3 months (group A) and were compared with a control group of 27 patients (group B).ResultsIn group A, 22 patients (79xa0%) were eligible for cardioversion; sinus rhythm was restored in 18 (82xa0%) of these, with no procedural complications. After 12xa0months, 16 patients (58xa0%) in group A were in sinus rhythm, compared with one group B patient who spontaneously recovered sinus rhythm (4xa0%, pu2009<u20090.001). On 12-month evaluation, ejection fraction had improved in both groups, but a reduction in left ventricular end-systolic volume was recorded only in group A patients (pu2009=u20090.018 versus baseline).ConclusionsIn patients with permanent AF, the rhythm control strategy consisting of internal cardioversion, performed by means of the implanted cardioverter–defibrillator after 3xa0months of CRT, was associated with a high rate of sinus rhythm resumption on long-term follow-up and with a better echocardiographic response to CRT than that seen in patients treated according to a rate control strategy.

Biventricular pacing and heterogeneity of ventricular repolarization in heart failure patients

Objective: The aim of our study was to evaluate the effect of cardiac resyncronization therapy (CRT) on QT dispersion (QTd), JT dispersion (JTd) and transmural dispersion of re-polarization (TDR), markers of heterogeneity of ventricular repolarization in a study population with severe heart failure. Methods and Results: Fifty patients (43 male, 7 female, aged 60.2 ± 3.1 years) suffering from congestive heart failure (N = 39 NYHA class III; N = 11 NYHA class IV) as a result of coronary artery disease (N = 19) or of dilated cardiomyopathy (N = 31), sinus rhythm, QRS duration >130 ms (mean QRS duration >156 ± 21 ms), an ejection fraction < 35%, left ventricular end-diastolic diameter >55 mm, underwent permanent biventricular DDDR pacemaker implantation. A 12-lead standard electrocardiogram was performed at baseline, during right-, left-, and biventricular pacing and QTd, JTd and TDR were assessed. Biventricular pacing significantly reduced QTd (73.93 ± 19.4 ms during BiVP vs 91 ± 6.7 ms at sinus rhythm, p = 0.004), JTd (73.18 ± 17.16 ms during BiVP vs 100.72 ± 39.04 at baseline p = 0.003), TDR (93.16 ± 15.60 vs 101.55 ± 19.08 at baseline; p<0.004), as compared to sinus rhythm. Right ventricular endocardial pacing and left ventricular epicardial pacing both enhanced QTd (RVendoP 94 ± 51 ms, p<0.03; LVepiP 116 ±71 ms, p<0.02) and TDR (RVendoP 108.13 ± 19.94 ms; p<0.002; LVepiP 114.71 ± 26.1; p<0.05).There was no effect on JTd during right and left ventricular stimulation. Conclusions: Biventricular pacing causes a statistically significant reduction of ventricular heterogeneity of ripolarization and has an electrophysiological antiarrhythmic influence on arrhythmogenic substrate of dilatative cardiomiopathy.

Effects of defibrillation shock in patients implanted with a subcutaneous defibrillator: a biomarker study

Abstract Aims Implantable cardioverter defibrillator (ICD) shocks are associated with a subsequent increased risk of death, and an elevation of cardiac enzymes has been measured after defibrillation testing (DFT). In an experimental swine study, subcutaneous ICD (S-ICD) shocks caused less myocardial damage than traditional ICD shocks. The aim of our study was to investigate the association between S-ICD shock and acute cardiac damage in humans, as evaluated by means of sensitive and highly specific circulating biomarkers. Methods and results We calculated the variation in the serum levels of high-sensitivity cardiac troponin I (hs-CTnI) and creatine kinase-MB mass concentration (CK-MB mass), measured before and after an S-ICD shock delivered during intraoperative DFT. We also measured the degree of haemodynamic stress, as the variation in the serum levels of N-terminal pro-B-type natriuretic peptide (NT-proBNP) and copeptin (CP), after the S-ICD shock. We analysed 30 consecutive patients who received an S-ICD and who underwent DFT by means of a single 65u2009J shock. The levels of biomarkers did not change from baseline to 1u2009h post-shock, i.e. hs-CTnI (from 0.029u2009±u20090.005u2009ng/mL to 0.030u2009±u20090.005u2009ng/mL, Pu2009=u20090.079) and CK-MB mass (from 1.37u2009±u20090.17u2009ng/mL to 1.41u2009±u20090.18, Pu2009=u20090.080) and remained stable 6 and 24u2009h after DFT. The plasma NT-proBNP did not change, whereas CP levels were significantly higher at 1u2009h post-shock evaluation. However, 6u2009h after DFT, the levels had returned to the baseline and remained stable at 24u2009h. Conclusion The S-ICD shock did not seem to cause myocardial injuries. Although CP levels temporarily rose after DFT, they returned to basal levels within 6u2009h, which suggests that DFT does not have long-term prognostic implications. ICD shocks are associated with a subsequent increased risk of death, and an elevation of cardiac enzymes has been measured after DFT. We showed that serum levels of biomarkers of myocardial damage did not increase after high-energy DFT in patients who had undergone S-ICD device implantation. This suggests that S-ICD shock does not have long-term prognostic implications.

[Remote monitoring of implantable cardiac devices: health technology assessment ].

Clinical follow-up of patients with cardiac implantable electronic devices is challenging because of the increasing technical complexity of devices and clinical complexity of patients. Remote monitoring (RM) offers the opportunity to optimize clinic workflow and to improve device monitoring and patient management by reducing in-hospital visits, physician and nurse time required for patient follow-up, and hospital and social costs. Continuous RM may lead to early detection of device malfunctions and clinical events, such as arrhythmias and heart failure. Early reaction may improve patient outcome. RM is easy to use and patients show a high level of acceptance and satisfaction. Implementing RM in daily practice may require changes in clinical workflow. Primary nursing-based models have demonstrated the best results. In spite of a favorable cost-benefit ratio, RM reimbursement still represents an issue in several European countries, including Italy, which limits widespread RM utilization. The fee-for-service payment approach, the global budget for device patient follow-up and/or integrated care packages for heart failure management represent the keys to introduce reimbursement and to improve patient care, while reducing healthcare costs.

11. Cardiac Resynchronization Therapy: Different Issues

Objective Cardiac resynchronization therapy (CRT) using biventricular pacing has been a major advance in long-term therapy for treatment of congestive heart failure (CHF). Heart rate variability (HRV) analysis has become an important predictive tool in CHF for the effects arrhythmogenic. In our study we observed if CRT can affect HRV in patients with CHF after six months of follow-up.nnMethods and Results 20 consecutive patients with CHF (12 men and 8 women; mean age 64.9 ± 11.8, range 48-79 years, NYHA class III-IV, FE 120 ms., intraventricular and interventricular delay) received biventricular pacing (Guidant Renewal 4). HRV recorded by implanted device and was performed at implantation and six months after procedure. After implantation QRS duration changed from 156 ± 21msec to 132 ± 16msec (p<0.001) and NYHA class decreased in all patients.nnHRV improved at follow-up (SDANN 66.8 ± 24.8 vs. 86.6 ± 17.3, p <0.02) with reduction of main heart rate (81.8 ± 7.7 vs. 71.4 ± 4.2, p <0.01). EF improved progressively and were significantly higher at follow-up (24,5±4,15. vs 33,5±9,23, p< 0.05). The LVEDD was significantly smaller than baseline after 6 months (7,41±0.53 vs 5,93±0,77, p<0.03). The intraventricular electromechanical delay was significantly improved with a mean decreased of 27,9 msec (52,6±11,4 mesc vs 24,7±6,5, p<0,001), while interventricular electromechanical delay was shortened of 72,2 msec (92,6±12,7 msec vs 20,4±7,6 msec, p<0,003).nnDiscussion Our data shows that CRT in CHF seems improve autonomic function and reduce adrenergic tone as demonstrate by increasing HRV. In conclusion biventricular pacing can exert a positive effect on the mechanism that sustains the harmful hyper-adrenergic state and so it could be useful in opposition to disease progression.

11. Cardiac Resynchronization Therapy: Different Issues11.1 Heart Rate Variability and Biventricular Pacing

Objective Cardiac resynchronization therapy (CRT) using biventricular pacing has been a major advance in long-term therapy for treatment of congestive heart failure (CHF). Heart rate variability (HRV) analysis has become an important predictive tool in CHF for the effects arrhythmogenic. In our study we observed if CRT can affect HRV in patients with CHF after six months of follow-up.nnMethods and Results 20 consecutive patients with CHF (12 men and 8 women; mean age 64.9 ± 11.8, range 48-79 years, NYHA class III-IV, FE 120 ms., intraventricular and interventricular delay) received biventricular pacing (Guidant Renewal 4). HRV recorded by implanted device and was performed at implantation and six months after procedure. After implantation QRS duration changed from 156 ± 21msec to 132 ± 16msec (p<0.001) and NYHA class decreased in all patients.nnHRV improved at follow-up (SDANN 66.8 ± 24.8 vs. 86.6 ± 17.3, p <0.02) with reduction of main heart rate (81.8 ± 7.7 vs. 71.4 ± 4.2, p <0.01). EF improved progressively and were significantly higher at follow-up (24,5±4,15. vs 33,5±9,23, p< 0.05). The LVEDD was significantly smaller than baseline after 6 months (7,41±0.53 vs 5,93±0,77, p<0.03). The intraventricular electromechanical delay was significantly improved with a mean decreased of 27,9 msec (52,6±11,4 mesc vs 24,7±6,5, p<0,001), while interventricular electromechanical delay was shortened of 72,2 msec (92,6±12,7 msec vs 20,4±7,6 msec, p<0,003).nnDiscussion Our data shows that CRT in CHF seems improve autonomic function and reduce adrenergic tone as demonstrate by increasing HRV. In conclusion biventricular pacing can exert a positive effect on the mechanism that sustains the harmful hyper-adrenergic state and so it could be useful in opposition to disease progression.

Heart Rate Variability and Biventricular Pacing

Objective Cardiac resynchronization therapy (CRT) using biventricular pacing has been a major advance in long-term therapy for treatment of congestive heart failure (CHF). Heart rate variability (HRV) analysis has become an important predictive tool in CHF for the effects arrhythmogenic. In our study we observed if CRT can affect HRV in patients with CHF after six months of follow-up.nnMethods and Results 20 consecutive patients with CHF (12 men and 8 women; mean age 64.9 ± 11.8, range 48-79 years, NYHA class III-IV, FE 120 ms., intraventricular and interventricular delay) received biventricular pacing (Guidant Renewal 4). HRV recorded by implanted device and was performed at implantation and six months after procedure. After implantation QRS duration changed from 156 ± 21msec to 132 ± 16msec (p<0.001) and NYHA class decreased in all patients.nnHRV improved at follow-up (SDANN 66.8 ± 24.8 vs. 86.6 ± 17.3, p <0.02) with reduction of main heart rate (81.8 ± 7.7 vs. 71.4 ± 4.2, p <0.01). EF improved progressively and were significantly higher at follow-up (24,5±4,15. vs 33,5±9,23, p< 0.05). The LVEDD was significantly smaller than baseline after 6 months (7,41±0.53 vs 5,93±0,77, p<0.03). The intraventricular electromechanical delay was significantly improved with a mean decreased of 27,9 msec (52,6±11,4 mesc vs 24,7±6,5, p<0,001), while interventricular electromechanical delay was shortened of 72,2 msec (92,6±12,7 msec vs 20,4±7,6 msec, p<0,003).nnDiscussion Our data shows that CRT in CHF seems improve autonomic function and reduce adrenergic tone as demonstrate by increasing HRV. In conclusion biventricular pacing can exert a positive effect on the mechanism that sustains the harmful hyper-adrenergic state and so it could be useful in opposition to disease progression.