Mitral valvuloplasty complicated by catheter perforation of the right atrium and the aortic root.

According to latest guidelines, percutaneous mitral commissurotomy (PMC) represents the first-line treatment for symptomatic severe mitral valve stenosis with favorable morphology. We report successful surgical treatment of a potential life-threatening complication occurred during PMC. Heart-team discussion and closed collaboration with centers are crucial for decision-making and cardiac surgery onsite should be ensured for high-risk procedures.

Cardiac resynchronization therapy non-responder to responder conversion rate in the more response to cardiac resynchronization therapy with MultiPoint Pacing (MORE-CRT MPP) study: results from Phase I.

AIMS: To assess the impact of MultiPoint™ Pacing (MPP)-programmed according to the physician's discretion-in non-responders to standard biventricular pacing after 6 months. METHODS AND RESULTS: The study enrolled 1921 patients receiving a quadripolar cardiac resynchronization therapy (CRT) system capable of MPP™ therapy. A core laboratory assessed echocardiography at baseline and 6 months and defined volumetric non-response to biventricular pacing as <15% reduction in left ventricular end-systolic volume (LVESV). Clinical sites randomized patients classified as non-responders in a 1:1 ratio to receive MPP (236 patients) or continued biventricular pacing (231 patients) for an additional 6 months and evaluated rate of conversion to echocardiographic response. Baseline characteristics of both groups were comparable. No difference was observed in non-responder to responder conversion rate between MPP and biventricular pacing (31.8% and 33.8%, P = 0.72). In the MPP arm, 68 (29%) patients received MPP programmed with a wide LV electrode anatomical separation (≥30 mm) and shortest LV1-LV2 and LV2-RV timing delays (MPP-AS); 168 (71%) patients received MPP programmed with other settings (MPP-Other). MPP-AS elicited a significantly higher non-responder conversion rate compared to MPP-Other (45.6% vs. 26.2%, P = 0.006) and a trend in a higher conversion rate compared to biventricular pacing (45.6% vs. 33.8%, P = 0.10). CONCLUSIONS: After 6 months, investigator-discretionary MPP programming did not significantly increase echocardiographic response compared to biventricular pacing in CRT non-responders.

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.

Performance of the Durata implantable cardioverter defibrillator lead: results of an independent multicenter study.

AIMS: The high rate of implantable cardioverter defibrillator (ICD) lead failures related to the Sprint Fidelis' and Riata's design have raised serious concerns about the reliability of ICD leads. The St. Jude Medical Durata family of leads replaced the preceding Riata line following increased rates of lead failure (1.17% per year). The aim of our study was to evaluate the long-term performance of the Durata lead. METHODS: Eight hundred and eighteen Durata ICD leads were implanted in 11 Italian centers. The incidence of lead failure, defined as a sudden rise in long-term pacing or defibrillation impedance and/or a sudden change in R-wave amplitude and capture thresholds, was assessed. The incidences of lead dislodgment and lead perforation were also evaluated. RESULTS: During a median follow-up of 1353 days (3.7 years; 25-75th interquartile range 806-1887 days) lead failure occurred in 16/818 leads (0.54%/year). The overall survival, free of lead failure, was 98.9% at 3 years, 98.2% at 4 years and 97.5% at 5 years. Lead dislodgment occurred in 12/818 leads with an incidence of 0.4%/year. No cases of cardiac perforation were reported. No major adverse events were reported except for two cases of inappropriate shocks as a consequence of failure or dislodgment. CONCLUSION: Our study suggests that the Durata lead does not engender a higher risk of failure. Overall survival, free from lead failure, was found to be higher than previously reported for the Riata lead.

Atrial fibrillation in recipients of cardiac resynchronization therapy device: 1-year results of the randomized MASCOT trial.

BACKGROUND: Atrial fibrillation (AF) is associated with increased morbidity and mortality in patients suffering from heart failure (HF). Patients in New York Heart Association HF classes III or IV, with systolic dysfunction and a wide QRS, are candidates for cardiac resynchronization therapy (CRT), and might benefit from atrial overdrive pacing (AOP). METHODS: The Management of Atrial fibrillation Suppression in AF-HF COmorbidity Therapy (MASCOT) trial enrolled 409 CRT device recipients (79% men), who were randomly assigned to AOP ON (n = 197), versus AOP OFF (n = 197) and followed up for 1 year. Their mean age was 68 +/- 10 years, left ventricular ejection fraction 25 +/- 6%, QRS duration 163 +/- 29 milliseconds. New York Heart Association class III was present in 86% of patients and 19% had a history of paroxysmal AF. The primary study end point was incidence of permanent AF at 1 year. RESULTS: Atrial overdrive pacing increased the percentage of atrial pacing from 30% to 80% (P < .0001), was well tolerated, and did not interfere with (a) delivery of CRT (95% mean ventricular pacing in both groups), (b) response to CRT (70% responders in the control vs 67% in the treatment group), or (c) cardiac function (left ventricular ejection fraction increased from 24.5% +/- 6.2% to 32.7% +/- 10.9% in the control and from 25.8% +/- 6.8% to 33.1% +/- 12.6% in the treatment group). The incidence of permanent AF was 3.3% in both groups. By logistic regression analysis, a history of AF (P < .001) and absence of antiarrhythmic drugs (P = .002) were associated with permanent AF. CONCLUSIONS: In this first trial of a specific AF prevention algorithm in CRT recipients, AOP was safe and did not worsen HF. The prevention algorithm did not lower the 1-year incidence of AF.

Economic analysis of remote monitoring of cardiac implantable electronic devices: Results of the Health Economics Evaluation Registry for Remote Follow-up (TARIFF) study.

BACKGROUND: Remote monitoring (RM) of cardiac implantable electronic devices has been demonstrated to improve outpatient clinic workflow and patient management. However, few data are available on the socioeconomic impact of RM. OBJECTIVE: The aim of this study was to assess the costs and benefits of RM compared with standard care (SC). METHODS: We used 12-month patient data from the Health Economics Evaluation Registry for Remote Follow-up (TARIFF) study (N = 209; RM: n = 102 (48.81%); SC: n = 107 (51.19%)). Cost comparison was made from 2 perspectives: the health care system (HCS) and patients. The use of health care resources was defined on the basis of hospital clinical folders. Out-of-pocket expenses were reported directly by patients. RESULTS: HCS perspective: The overall mean annual cost per patient in the SC group (€1044.89 ± €1990.47) was significantly higher than in the RM group (€482.87 ± €2488.10) (P < .0001), with a reduction of 53.87% being achieved in the RM group. The primary driver of cost reduction was the cost of cardiovascular hospitalizations (SC: €`886.67 ± €1979.13 vs RM: €432.34 ± €2488.10; P = .0030). Patient and caregiver perspective: The annual cost incurred by patients was significantly higher in the SC group than in the RM group (SC: €169.49 ± €189.50 vs RM: €56.87 ± €80.22; P < .0001). Patients' quality-adjusted life-years were not significantly different between the groups. Provider perspective: The total number of inhospital device follow-up visits was reduced by 58.78% in the RM group. CONCLUSION: RM of patients with cardiac implantable electronic devices (CIEDs) is cost saving from the perspectives of the HCS, patients, and caregivers. Introducing appropriate reimbursements will make RM sustainable even for the provider, i.e. the hospitals which provide the service and encourage widespread adoption of RM.

Impact of in-clinic follow-up visits in patients with implantable cardioverter defibrillators: demographic and socioeconomic analysis of the TARIFF study population.

PURPOSE: Remote monitoring of cardiac implantable electronic devices has been demonstrated to safely reduce frequency of hospital visits. Limited studies are available evaluating the economic impact. The aim of this article is to highlight the social impact and costs for the patients associated with hospital visits for routine device follow-up at the enrollment visit for the TARIFF study (NCT01075516). METHODS: TARIFF is a prospective, cohort, observational study designed to compare the costs and impact on quality of life between clinic-based and remote care device follow-up strategies. RESULTS: Two hundred nine patients (85.2 % males) were enrolled in the study; 153 patients (73.2 %) were retired, 36 (17.2 %) were active workers, 18 (8.6 %) were housewives, and 2 (1.0 %) were looking for a job. Among active workers, 63.9 % required time off from work to attend the hospital visit, while 67.0 % of all patients had to interrupt daily activities. The majority of patients spent half a day or more attending the visit. A carer accompanied 77 % of patients. Among carers, 36.6 % required time off from work, and 77.6 % had to interrupt daily activities. Median distance traveled was 36 km. The average cost of travel was 10 euros with 25 % of patients spending more than 30 euros. CONCLUSIONS: Data from patients enrolled in the TARIFF registry confirm that there are social and economic impacts to patients attending routine device checks in hospital which can be significantly reduced by using a remote monitoring strategy.

Role of ventricular Autocapture function in increasing longevity of DDDR pacemakers: a prospective study.

AIMS: Autocapture is an algorithm for automatic adaptation of ventricular output to capture threshold. The aim of this prospective study was to estimate the effects of ventricular Autocapture algorithm on DDD-DDDR pacemaker longevity. METHODS AND RESULTS: Eighty-three patients implanted with a DDD-DDDR pacemaker (Affinity or Entity; St Jude Medical, USA) were enrolled and the Autocapture function was activated pre-discharge. Ventricular pulse duration was randomly programmed at 0.3 or 0.4 ms, with a cross-over at 8-12 weeks and again at 13-14 months. Diagnostic data were retrieved from device memory and by calculating battery current drain from long-term threshold recordings; device longevity was estimated at the following settings: Autocapture with a pulse duration of 0.3 and 0.4 ms, respectively, standard output (3.5 V, 0.4 ms) and conventional low output programming (2.5 V, 0.4 ms). According to a series of assumptions, Autocapture was associated with a 55-60% increase in estimated device longevity compared with standard output programming and a 6-7% increase in longevity compared with low output programming. No significant differences were found between Autocapture programmed with a pulse duration of 0.3 or 0.4 ms. In projections to a 10-year follow-up, use of the Autocapture function resulted in a 42% reduction in pacing-related estimated costs compared with standard output programming at 3.5 V, 0.4 ms. CONCLUSION: Pacing with constant adaptation of ventricular output in dual-chamber devices has the potential to increase generator longevity and to reduce sizeably pacing-related costs compared with standard programming.

Role of rate control and regularization through pacing in patients with chronic atrial fibrillation and preserved ventricular function: the VRR study.

AIM: High heart rates in chronic atrial fibrillation (CAF) is one of the factors responsible for hemodynamic alterations and may lead to tachycardiomyopathies. The ventricular rate regulation (VRR) study evaluates the effect of ventricular rate regularization in CAF patients with preserved ventricular function, marked ventricular rate variability, and indications for pacemaker (PM) implantation owing to symptomatic pauses. Rate regularization was achieved using VRR algorithm (INSIGNIA pacemakers, Guidant Corp., St. Paul, MN, USA). METHODS: One month after PM implantation, 58 patients followed two 3-month crossover periods (VRR-OFF; VRR-ON) in which the VRR algorithm was randomized and compared to fixed rate stimulation at 60 ppm. During follow-up visits a 6-minute walk test was performed under partially inhibited conditions (PM at 40 ppm) and ventricular response was recorded. The following parameters were measured: mean ventricular rate (MR), rate variability (RR30), rate recovery after exercise (SLOPE = (R-END - R-REC)/(R-END - 40)), R-END being the rate at end of walk and R-REC the rate 1 minute after exercise. RESULTS: The VRR algorithm decreased rate variability (RR30: -7.36 +/- 8.8; P < 0.01) without increasing ventricular rate (MR: -1.11 +/- 8.3 P = NS), while SLOPE improved significantly (SLOPE: +15.41 +/- 16.8 P < 0.01). CONCLUSIONS: VRR effectively stabilizes rate, without increasing pacing rate above spontaneous rhythm and helps achieve a more favorable autonomic balance, improving rate recovery after exercise.

Is a dual-sensor pacemaker appropriate in patients with sino-atrial disease? Results from the DUSISLOG study.

BACKGROUND: Rate-responsive pacemakers (PMs) are often supplied with accelerometer (XL) and minute ventilation (MV) sensors to provide a physiologic rate response according to patient needs. No information is available about the real benefit of dual-sensor rate-responsive pacing on the daily life of patients. METHODS: DUSISLOG (Dual Sensor vs Single Sensor comparison using patient activity LOGbook) is a two-arm prospective, randomized, multicenter study that enrolled 105 patients who received a rate-responsive PM (Insignia), Guidant Corp.). After 1 month of DDD pacing at 60 ppm lower rate, a single sensor (XL or MV, randomized) was activated for 3 months at the manufacturer's suggested nominal settings, followed by a 3-month period with dual sensors optimized with automatic response. During the last month of each period, the following data concerning patient physical activity were retrieved from PM diagnostics (Activity Log): mean percentage of physical activity, mean intensity of activity. Quality of life (QoL) scores and 6-minute walk test (WT) were also recorded. RESULTS: Single-sensor rate-responsive pacing resulted in symptomatic benefit equally with XL and MV sensors while no additional benefit was found using dual sensor. In a subgroup analysis, patients (17%) with marked chronotropic incompetence and with 0% atrial sensing received benefits from single sensor with an additional advantage from sensor (QoL: +21 +/- 14% P < 0.05; WT: +17 +/- 7% P < 0.02). CONCLUSION: In most patients with rate-responsive devices, a single sensor is sufficient to achieve a satisfactory rate response. A dual sensor combination and optimization provides an additional benefit only in a selected population with an advanced atrial chronotropic disease.

Predictors of atrial antitachycardia pacing efficacy in patients affected by brady-tachy form of sick sinus syndrome and implanted with a DDDRP device.

UNLABELLED: Predictors of ATP efficacy in brady/tachy patients. BACKGROUND: Recent options to treat atrial tachyarrhythmias (ATA) include implantable devices delivering antitachycardia pacing therapies (ATP). No prospective study selected patients with higher chances of episode termination by ATP or indicated the most effective ATP use. Our aim was to study ATP efficacy in patients with brady-tachy form of sinus node disease (SND), identifying clinical factors, ATA characteristics, and device features predicting ATP efficacy. METHODS AND RESULTS: Three hundred and sixteen patients (105 M, aged 71.1+/-8.8 years) received a DDDRP pacemaker and were prospectively followed. Median follow-up was 18 months: 37,125 ATA episodes occurred in 217 patients; ATP treated 5,536 of them. Overall, ATP efficacy was 50.0%. A multivariate analysis identified longer arrhythmia cycle lengths (OR=1.25; CI=1.07-1.47) and shorter delays to ATP delivery (OR=0.15; CI=0.10-0.22) as independent predictors of ATP efficacy for episodes preceded by >or=5 minutes of sinus rhythm. Additionally, ATP efficacy for all treated episodes was predicted by lower New York Heart Association (NYHA) class (OR=0.64; CI=0.42-0.98), episode classification as nonimmediate recurrence of ATA (non-IRAT) (OR=0.07; CI=0.02-0.33), absence of overlap in the device detection windows (OR=0.54; CI=0.32-0.91), and flecainide treatment (OR=2.22; CI=1.04-4.71). CONCLUSIONS: In patients paced for SND, multivariate analysis shows that ATP efficacy is associated to longer arrhythmia cycle lengths, shorter ATP delivery delays, NYHA class I, episode classification as non-IRAT, absence of overlap in the atrial arrhythmia device detection windows, and flecainide treatment.