Management of a patient with multiple device replacements and extractions: When the leadless pacemaker is a viable solution.

Leadless pacemaker (LPs) is a safe device and the implantation rates of this device is increasing. The device extraction and replacement are today a challenging procedures especially in case of infections, fragile and older patients or in unfavorable venous anatomy; LPs can be a valid alternative strategy in these cases. We report a case of management of a patient with multiple previous device replacements and extractions, with malfunction of transvenous pacemaker and with a fibrous membrane between the walls of the ventricular lead and the superior vena cava (SVC), who underwent a successful LP implantation.

Mortality after cardioverter-defibrillator replacement: Results of the DECODE survival score index.

BACKGROUND: Device replacement is the ideal time to reassess health care goals regarding continuing implantable cardioverter-defibrillator (ICD) therapy. Only few data are available on the decision making at this time. OBJECTIVES: The goals of this study were to identify factors associated with poor prognosis at the time of ICD replacement and to develop a prognostic index able to stratify those patients at risk of dying early. METHODS: DEtect long-term COmplications after implantable cardioverter-DEfibrillator replacement (DECODE) was a prospective, single-arm, multicenter cohort study aimed at estimating long-term complications in a large population of patients who underwent ICD/cardiac resynchronization therapy - defibrillator replacement. Potential predictors of death were investigated, and all these factors were gathered into a survival score index (SUSCI). RESULTS: We included 983 consecutive patients (median age 71 years (63-78)); 750 (76%) were men, 537 (55%) had ischemic cardiomyopathy; 460 (47%) were implanted with cardiac resynchronization therapy - defibrillator. During a median follow-up period of 761 days (interquartile range 628-904 days), 114 patients (12%) died. In multivariate Cox regression analysis, New York Heart Association class III/IV, ischemic cardiomyopathy, body mass index < 26 kg/m2, insulin administration, age ≥ 75 years, history of atrial fibrillation, and hospitalization within 30 days before ICD replacement remained associated with death. The survival score index showed a good discriminatory power with a hazard ratio of 2.6 (95% confidence interval 2.2-3.1; P < .0001). The risk of death increased according to the severity of the risk profile ranging from 0% (low risk) to 47% (high risk). CONCLUSION: A simple score that includes a limited set of variables appears to be predictive of total mortality in an unselected real-world population undergoing ICD replacement. Evaluation of the patient's profile may assist in predicting vulnerability and should prompt individualized options, especially for high-risk patients.

Direct Oral Anticoagulants in the Setting of Catheter Ablation of Atrial Fibrillation: State of art.

Atrial fibrillation (AF) represents the arrhythmia of greatest clinical impact and catheter ablation of AF (CAAF) has become the most effective strategy for rhythm control in selected patients. Therefore, appropriate anticoagulation strategies are of paramount importance for patients undergoing CAAF, especially those at high risk, such those with high CHA2DS2VASc scores. Optimal management of anticoagulation before, during, and after CAAF is crucial. Several studies have evaluated the use of different anticoagulation strategies in the periprocedural period. Randomized controlled trial seem to suggest that in patients undergoing CAAF, uninterrupted (or minimally interrupted) direct oral anticoagulants (DOACs) provides an alternative to continuous vitamin K antagonists strategy, with low thromboembolic and bleeding risk.

Chronic Apical and Nonapical Right Ventricular Pacing in Patients with High-Grade Atrioventricular Block: Results of the Right Pace Study.

OBJECTIVE: The aim of the study was to compare the two approaches to chronic right ventricular pacing currently adopted in clinical practice: right ventricular apical (RVA) and non-RVA pacing. BACKGROUND: Chronic RVA pacing is associated with an increased risk of atrial fibrillation, morbidity, and even mortality. Non-RVA pacing may yield more physiologic ventricular activation and provide potential long-term benefits and has recently been adopted as standard procedure at many implanting centers. METHODS: The Right Pace study was a multicenter, prospective, single-blind, nonrandomized trial involving 437 patients indicated for dual-chamber pacemaker implantation with a high percentage of RV pacing. RESULTS: RV lead-tip target location was the apex or the interventricular septum. RVA (274) and non-RVA patients (163) did not differ in baseline characteristics. During a median follow-up of 19 months (25th-75th percentiles, 13-25), 17 patients died. The rates of the primary outcome of death due to any cause or hospitalization for heart failure were comparable between the groups (log-rank test, p = 0.609), as were the rates of the composite of death due to any cause, hospitalization for heart failure, or an increase in left ventricular end-systolic volume ≥ 15% as compared with the baseline evaluation (secondary outcome, p = 0.703). After central adjudication of X-rays, comparison between adjudicated RVA (239 patients) and non-RVA (170 patients) confirmed the absence of difference in the rates of primary (p = 0.402) and secondary (p = 0.941) outcome. CONCLUSIONS: In patients with indications for dual-chamber pacemaker who require a high percentage of ventricular stimulation, RVA or non-RVA pacing resulted in comparable outcomes. This study is registered with ClinicalTrials.gov (identifier: NCT01647490).

[Horizons and perspectives on the problem of non--responders to cardiac resynchronization therapy.] / Focus sui non responder alla terapia di resincronizzazione cardiaca: orizzonti e prospettive.

Cardiac resynchronization therapy (CRT) has been shown as a successful strategy in the treatment of patients with heart failure and electrical dyssincrony. However, a significant proportion of implanted patients fails to respond sufficiently or in a predictable manner. Consequently, non response to CRT remains a valuable problem in clinical practice. In order to improve CRT response and long-term clinical benefits, the proper evaluation of patient's global frialty, the technology improvement, the multimodality imaging approach and the use of simple and low cost electrographic parameters (to verify effective biventricular capture and QRS narrowing) could play a important role. Therefore, the integration of various medical expertises (clinical cardiology, cardiac advanced imaging, electrophysiology) is a crucial element in order to achive the maximal benefits from this promising tecnique. In the multistep process (from patients evaluation to results verification) the follow-up even from the earliest post implantation phase, should be managed with great attention having the potential for impact the prognosis. This brief review focus the problem of non responder to CRT, giving particular attention to the different variables that may play a role (comorbilities, improvement in the tecnology of device implantation, role of multimodality imaging and electrocardiographic parameters).

Non-responders to cardiac resynchronization therapy: Insights from multimodality imaging and electrocardiography. A brief review.

BACKGROUND: Cardiac resynchronization therapy (CRT) is a successful strategy for heart failure (HF) patients. The pre-requisite for the response is the evidence of electrical dyssynchrony on the surface electrocardiogram usually as left bundle branch block (LBBB). Non-response to CRT is a significant problem in clinical practice. Patient selection, inadequate delivery and sub-optimal left ventricle lead position may be important causes. OBJECTIVES: In an effort to improve CRT response multimodality imaging (especially echocardiography, computed tomography and cardiac magnetic resonance) could play a decisive role and extensive literature has been published on the matter. However, we are so far from routinary use in clinical practice. Electrocardiography (with respect to left ventricle capture and QRS narrowing) may represent a simple and low cost approach for early prediction of potential non-responder, with immediate practical implications. CONCLUSION: This brief review covers the current recommendations for CRT in HF patients with particular attention to the potential benefits of multimodality imaging and electrocardiography in improving response rate.

Magnitude of QRS duration reduction after biventricular pacing identifies responders to cardiac resynchronization therapy.

BACKGROUND: Several studies have investigated the association between native QRS duration (QRSd) or QRS narrowing and response to biventricular pacing. However, their results have been conflicting. The aim of our study was to determine the association between the relative change in QRS narrowing index (QI) and clinical outcome and prognosis in patients who undergo cardiac resynchronization therapy (CRT) implantation. METHODS AND RESULTS: We included 311 patients in whom a CRT device was implanted in accordance with current guidelines for CRT. On implantation, the native QRS, the QRSd and the QI during CRT were measured. After 6months, 220 (71%) patients showed a 10% reduction in LVESV. The median [25th-75th] QI was 14.3% [7.2-21.4] and was significantly related to reverse remodeling (r=+0.22; 95%CI: 0.11-0.32, p=0.0001). The cut-off value of QI that best predicted LV reverse remodeling after 6months of CRT was 12.5% (sensitivity=63.6%, specificity=57.1%, area under the curve=0.633, p=0.0002). The time to the event death or cardiovascular hospitalization was significantly longer among patients with QI>12.5% (log-rank test, p=0.0155), with a hazard ratio (HR) of 0.3 [95%CI: 0.11-0.78]. In the multivariate regression model adjusted for baseline parameters, a 10% increment in QI (HR=0.61[0.44-0.83], p=0.002) remained significantly associated with CRT response. CONCLUSIONS: Patients with a larger decrease in QRSd after CRT initiation showed greater echocardiographic reverse remodeling and better outcome from death or cardiovascular hospitalization. QI is an easy-to-measure variable that could be used to predict CRT response at the time of pacing site selection or pacing configuration programming.

Detect Long-term Complications After ICD Replacement (DECODE): Rationale and Study Design of a Multicenter Italian Registry.

The replacement of implantable cardioverter-defibrillators (ICDs) may give rise to considerable clinical consequences, the importance of which is underrated by the medical community. Replacement-related adverse events are difficult to identify and require monitoring of both short-term complications and long-term patient outcome. The aim of this study is to perform a structured evaluation of both short- and long-term adverse events and a cost analysis of consecutive ICD replacement procedures. Detect Long-term Complications After ICD Replacement (DECODE) is a prospective, single-arm, multicenter cohort study designed to estimate long-term complication rates (at 12 months and 5 years) in patients undergoing ICD generator replacement. The study will also evaluate predictors of complications, patient management before and during the replacement procedure in clinical practice, and the costs related to use of health care resources. About 800 consecutive patients with standard indications for ICD generator replacement will be enrolled in this study. The decision to undertake generator replacement/upgrade will be made according to the investigators' own judgment (which will be recorded). Patients will be followed for 60 months through periodic in-hospital examinations or remote monitoring. Detailed data on complications related to ICD replacement in current clinical practice are still lacking. The analysis of adverse events will reveal the value of new preventive strategies, thereby yielding both clinical and economic benefits. Moreover, assessment of complication rates after ICD replacement in a real-life setting will help estimate the actual long-term cost of ICD therapy and assess the real impact of increasing ICD longevity on cost-effectiveness.

[Short-term effects of stimulation in the right ventricular outflow tract]. / Effetti a breve termine della stimolazione in tratto di efflusso del ventricolo destro.

INTRODUCTION: Stimulation in the right ventricular outflow tract (RVOT) showed better clinical and hemodynamic results at short, medium and long term than apical pacing. METHODS: We enrolled 30 patients undergoing pacemaker implantation with positioning of electrocatheters in the high or low RVOT. All patients underwent clinical, echocardiographic and electrocardiographic evaluation after implantation and at 6-month follow-up. RESULTS: After 6 months of pacing, no significant changes in echocardiographic parameters were observed, whereas differences were found between the duration of spontaneous QRS and the duration of QRS stimulated at the time of implantation. Electrocatheter implantation in the high RVOT showed a particular benefit. CONCLUSIONS: Chronic stimulation in RVOT, preferably in the high tract, can be considered a viable alternative to apical pacing in patients with likely high rates of stimulation, especially of young age.

Is there a right place to pace the right ventricle? Evaluation of apical and septal positions in a pacemaker population: study protocol for a prospective intervention-control trial.

INTRODUCTION: The main objective of research in pacemaker therapy has been to provide the best physiologic way to pace the heart. Despite the good results provided by right ventricular pacing minimization and by biventricular pacing in specific subsets of heart failure patients, these options present many limitations for standard pacemaker recipients. In these patients, pacing the right ventricle at alternative sites could result in a lower degree of left intraventricular dyssynchrony. Despite the lack of strong evidence and the difficulty in placing and accurately classifying the final lead position, pacing at alternative right ventricular sites seems to have become a standard procedure at many implanting centers. MATERIAL AND METHODS: The RIGHT PACE study is a multi-center, prospective, single-blind, double-arm, intervention-control trial comparing right ventricular pacing from the apex and from the septal site in terms of left intraventricular dyssynchrony. A total of 408 patients with indications for cardiac pacing but without indications for ICD and/or CRT will be enrolled. Investigators will be divided on the basis of their prior experience of selective site pacing lead implantation and patients will be treated according to the clinical practice of the centers. After device implantation, they will be followed up for 24 months through evaluation of clinical, echocardiographic and safety/system-performance variables. DISCUSSION: This study might provide important information about the impact of the right ventricular pacing on the left ventricular dyssynchrony, and about acute and chronic responses to selective site pacing, as adopted in current clinical practice. This trial is registered at ClinicalTrials.gov (ID:NCT01647490). TRIAL REGISTRATION: Right Ventricular Lead Placement in a Pacemaker Population: Evaluation of apical and alternative position. ClinicalTrials.gov: NCT01647490.

Bifocal stimulation in patient with congenitally corrected transposition of great vessels.

Congenitally corrected transposition of the great vessels (CCTGV) is a rare congenital heart defect associated with multiple cardiac morphological abnormalities and conduction defects. Complete atrioventricular (AV) block occurs in 30% of patients and it may be present at birth or develop later with a rate of 2% per year; moreover, a systemic right ventricle is frequently characterized by heart failure in adult life. We used a bifocal cardiac stimulation for a young woman affected by CCTGV and atrioventricular Mobitz 2 and 2:1 block, considering structural, anatomic condition, and the high rate of pacing she underwent.

Takotsubo cardiomiopathy after acute diarrhea.

Takotsubo cardiomyopaty is a recently described syndrome characterized by transient left ventricular dysfunction, mimicking an acute coronary syndrome and usually precipitated by a physical or emotional stress. We report the first case of Takotsubo cardiomyopathy after acute diarrhea in a man. It may be argued that severe diarrhea in predisposed individuals may cause an acute stress resulting in increased sympathetic activity leading to this syndrome. Probably the relationship between the adrenergic system and the heart is more complex than general thought and the stimuli which favor an autonomic imbalance and precipitate the syndrome are very disparate in clinical practice.

Midventricular dyskinesia during clozapine treatment?

This is the case of a young man suffering from schizophrenia and treated with clozapine. He developed acute heart failure associated with pericardial effusion and midventricular dyskinesia with severe systolic dysfunction and left ventricular dilatation at echocardiogram, readily resolved after the suspension of clozapine therapy. The segmental wall motion abnormalities observed at echocardiogram in this case are peculiar and have never been described before. The possible cardiotoxic effects of clozapine have been reported previously in the literature. Because of its serious potential side effects this drug is not considered the first choice for treatment of schizophrenia. Before beginning treatment, patients should undergo a cardiac evaluation, and they should also be periodically followed up with echocardiograms.

ICD implantation in noncompaction of the left ventricular myocardium: a case report.

Isolated noncompaction of the ventricular myocardium (INVM) is an uncommon cardiomyopathy characterized by the persistence of fetal myocardium with prominent trabecular meshwork and deep intertrabecular recesses, often associated with systolic dysfunction and ventricular dilatation. A 23-year-old man from Burkina Faso was referred to our operative unit with a diagnosis of INVM, made with echocardiogram and magnetic resonance imaging and nonsustained ventricular tachycardia. The literature reports the incidence of malignant ventricular arrhythmias in as many as 47% of the patients and sudden cardiac death in almost 50% of them and this supported our decision to perform implantable cardioverter-defibrillators implantation.

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.

[Right ventricular pacing: a resource or a threat?]. / Pacing ventricolare destro: una risorsa o una minaccia?

Early after the beginning of the pacemaker era, endocardial right ventricular apex has been the most extensively used site for cardiac pacing because it was easily accessible and reliable in a long-term perspective. However many data have demonstrated that this kind of pacing is suboptimal from a physiologic point of view because it causes several adverse effects such as altered ventricular contraction geometry, mitral regurgitation, perfusion alterations and interference with myocardial ion channels which determine a worsening of left ventricular function. Several strategies have been proposed to solve these problems (alternative pacing sites, specific algorithms able to reduce the percentage of ventricular pacing) which are still under evaluation. In this review we analyzed the effects of right apical ventricular pacing and its possible alternatives.

[Guidelines for the performance of electrophysiologic study: are they still current?]. / Linee guida all'esecuzione dello studio elettrofisiologico: sono ancora attuali?

The aim of the present study was to reevaluate the indications to electrophysiological study after the observation of various clinical trials such as MADIT, AVID and MUSTT. In this perspective, the guidelines of 1995 surely appear to be outdated. The present paper concludes that the indications which still appear acceptable are those which support catheter ablation, those regarding syncope of unexplained origin and, until the conclusions of MADIT-II are universally accepted, the indication included in the MADIT study.