Budget impact analysis of rivaroxaban vs. warfarin anticoagulation strategy for direct current cardioversion in non-valvular atrial fibrillation patients: the MonaldiVert Economic Study.

BACKGROUND: Rivaroxaban is the first novel oral anticoagulant to receive regulatory approval for non-valvular atrial fibrillation (NVAF) patients who require cardioversion. The MonaldiVert real life experience showed positive benefit-risk profile of short term rivaroxaban administration for transesophageal echocardiogram guided cardioversion in patients who had not achieved adequate pre-procedural vitamin K antagonist (VKA) anticoagulation. METHODS: Aim of our study was to perform a budget impact analysis of MonaldiVert anticoagulation strategy for direct current cardioversion in NVAF patients and to compare the following costs borne by the Regional Healthcare System (RHS) with those for a hypothetical cohort of identical patients underwent from the beginning to early rivaroxaban treatment before direct current cardioversion. RESULTS: The mean costs per each NVAF patient treated with VKA strategy and rivaroxaban rescue strategy were € 134.53 and € 189.83, respectively. Considering a hypothetical scenario in which all study population would be treated from the beginning with rivaroxaban (rivaroxaban early strategy), the mean cost per patient would have been € 81.11. The total cost borne by the RHS, including the cost of the cardioversion procedure, for the two therapeutic strategies carried out at Monaldi Hospital (VKA strategy and Rivaroxaban rescue strategy) was € 88,458.53. The total cost would be borne by the RHS for rivaroxaban early strategy, if applied to all study population, would have been € 69,989.15 with a saving of € 18,469.38 compared to the actually applied strategy. CONCLUSIONS: Rivaroxaban rescue strategy for transesophageal echocardiography guided direct current cardioversion in NVAF patients, who had not achieved adequate pre-procedural VKA anticoagulation, is an effective and safe strategy, which allows to not delay the procedure, reducing times and wastage of cardioversion slots, without substantial costs increase.

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

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 65 J shock. The levels of biomarkers did not change from baseline to 1 h post-shock, i.e. hs-CTnI (from 0.029 ± 0.005 ng/mL to 0.030 ± 0.005 ng/mL, P = 0.079) and CK-MB mass (from 1.37 ± 0.17 ng/mL to 1.41 ± 0.18, P = 0.080) and remained stable 6 and 24 h after DFT. The plasma NT-proBNP did not change, whereas CP levels were significantly higher at 1 h post-shock evaluation. However, 6 h after DFT, the levels had returned to the baseline and remained stable at 24 h. 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 6 h, 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 ]. / Monitoraggio remoto dei dispositivi cardiaci impiantabili: 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.

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

PURPOSE: Patients 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 3 months of CRT in patients with permanent AF and measured the long-term maintenance of sinus rhythm. METHODS: Twenty-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). RESULTS: In group A, 22 patients (79 %) were eligible for cardioversion; sinus rhythm was restored in 18 (82 %) of these, with no procedural complications. After 12 months, 16 patients (58 %) in group A were in sinus rhythm, compared with one group B patient who spontaneously recovered sinus rhythm (4 %, p < 0.001). 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 (p = 0.018 versus baseline). CONCLUSIONS: In patients with permanent AF, the rhythm control strategy consisting of internal cardioversion, performed by means of the implanted cardioverter-defibrillator after 3 months 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.

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.

Coronary sinus spasm during left ventricular lead implantation for biventricular pacing.

The authors present a case of coronary sinus spasm during left ventricular lead implantation for biventricular pacing relieved by direct infusion of nitroglycerin.

Influence of biventricular pacing on myocardial dispersion of repolarization in dilated cardiomyopathy patients.

AIMS: The aim of our study was to evaluate the effect of cardiac resyncronization therapy on QT dispersion (QTd), JT dispersion (JTd), and transmural dispersion of repolarization (TDR), markers of heterogeneity of ventricular repolarization in a study population with severe heart failure. METHODS AND RESULTS: Fifty patients (43 male, 7 female, age 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), with sinus rhythm (SR), QRS duration >120 ms (mean QRS duration=156+/-21 ms), an ejection fraction <35%, left ventricular end-diastolic diameter >55 mm, presence of atrioventricular asynchrony, intra- and inter-ventricular asynchrony, underwent permanent biventricular pacemaker implantation. A 12-lead standard electrocardiogram was performed at baseline, during right-, left-, and biventricular pacing (BiVP) and QTd, JTd, and TDR were assessed. BiVP significantly reduced QTd (73.93+/-19.4 ms during BiVP vs. 91+/-6.7 ms in SR, 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), compared with SR. Right ventricular endocardial pacing and left ventricular epicardial pacing both increased 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: BiVP causes a statistically significant reduction of ventricular heterogeneity of repolarization and has an electrophysiological anti-arrhythmic influence on the arrhythmogenic substrate of dilated cardiomyopathy.

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.

Assessment of accessory atrioventricular pathways by Doppler myocardial imaging.

PURPOSE: The use of electrophysiologic studies (EPS) for the localization of accessory atrioventricular connections in Wolff-Parkinson-White syndrome (WPW) requires accurate evaluation of the site of bypass tract insertion. Doppler myocardial imaging (DMI) is a new ultrasound technique that allows the detection of abnormal and early regional myocardial depolarization. The purpose of this study was to identify an abnormal pathway site in WPW patients. METHODS: Twenty-one patients with ventricular preexcitation were studied by DMI. Two-dimensional color DMI, velocity maps, acceleration maps, and pulsed-wave applications were used. A subsequent diagnostic EPS was performed. The results of EPS were taken as the gold standard diagnostic procedure. Radiofrequency catheter ablation therapy was then performed on all patients. RESULTS: The anomalous pathway was detected by DMI in 16 (76%) of 21 patients (9 [90%] of 10 with left pathways and 7 [64%] of 11 with right pathways), with respect to results of the EPS. Pathway detection was better with pulsed-wave DMI (76%) with its higher temporal resolution as compared with M-mode velocity map (57%) and acceleration map (47%). In most of the patients with successful radiofrequency ablation, an immediate resolution of the abnormal ventricular depolarization occurred and was detectable by DMI. CONCLUSIONS: Our findings demonstrate the feasibility of DMI to assess the early ventricular contraction associated with atrioventricular accessory pathways. Therefore, DMI appears to be a clinically useful adjunct to noninvasive evaluation of abnormal myocardial depolarization in WPW and to evaluate the results after radiofrequency ablation, even though its accuracy is considerably better for left-sided accessory pathways than for right-sided ones.