Low fluoroscopy permanent His bundle pacing using a new electroanatomic mapping system (KODEX EPD). A multicenter experience.

Background: His bundle pacing (HBP) may be a challenging procedure, often involving a long fluoroscopic time (FT) and a long procedural time (PT). We sought to evaluate whether the use of a new nonfluroscopic mapping (NFM) system, the KODEX-EPD, is able to reduce FT and PT when mapping is performed by the pacing catheter rather than an electrophysiological mapping catheter. Methods and Results: We included 46 consecutive patients (77 ± 8 years; 63% male) who underwent HBP; in 22 a NFM-guided procedure with the KODEX-EPD system was performed (group 1), whereas in 24 a conventional fluoroscopy-guided approach was used (group 2). Pacing indications were sick sinus syndrome in 13, atrioventricular block in 21, and cardiac resynchronization therapy in 12 cases. Both a lumen-less fixed helix lead and a stylet-driven extendable helix lead were used, respectively, in 24% and 76% of patients. HBP was successful in 22 patients (100%) in group 1 and 23 patients (96%) in group 2. The FT was significantly reduced in group 1 (183 ± 117 s vs 464.1 ± 352 s in group 2, p = .012). There were no significant differences between groups in PT and other procedural outcomes. Conclusions: The KODEX-EPD system may be safely used in HBP procedures. It is effective in reducing ionizing radiation exposure, as evidenced by the significant drop in FT, without increasing PT.

Rationale and design of the NO-PARTY trial: near-zero fluoroscopic exposure during catheter ablation of supraventricular arrhythmias in young patients.

INTRODUCTION: Radiofrequency catheter ablation is the mainstay of therapy for supraventricular tachyarrhythmias. Conventional radiofrequency catheter ablation requires the use of fluoroscopy, thus exposing patients to ionising radiation. The feasibility and safety of non-fluoroscopic radiofrequency catheter ablation has been recently reported in a wide range of supraventricular tachyarrhythmias using the EnSite NavX™ mapping system. The NO-PARTY is a multi-centre, randomised controlled trial designed to test the hypothesis that catheter ablation of supraventricular tachyarrhythmias guided by the EnSite NavX™ mapping system results in a clinically significant reduction in exposure to ionising radiation compared with conventional catheter ablation. METHODS: The study will randomise 210 patients undergoing catheter ablation of supraventricular tachyarrhythmias to either a conventional ablation technique or one guided by the EnSite NavX™ mapping system. The primary end-point is the reduction of the radiation dose to the patient. Secondary end-points include procedural success, reduction of the radiation dose to the operator, and a cost-effectiveness analysis. In a subgroup of patients, we will also evaluate the radiobiological effectiveness of dose reduction by assessing acute chromosomal DNA damage in peripheral blood lymphocytes. CONCLUSIONS: NO-PARTY will determine whether radiofrequency catheter ablation of supraventricular tachyarrhythmias guided by the EnSite NavX™ mapping system is a suitable and cost-effective approach to achieve a clinically significant reduction in ionising radiation exposure for both patient and operator.

Cardiac resynchronization therapy guided by the new KODEX-EPD imaging system.

Nowadays, fluoroscopy is the standard tool used to help physicians during pacing lead implantation. However, its use entails significant radiation exposure for physicians and especially for patients. For the first time, the present case report describes the use of the electro-anatomical mapping (EAM) navigation system KODEX-EPD for cardiac resynchronization therapy (CRT) implantation. These findings suggest that CRT implantation guided by the KODEX-EPD system is feasible and safe with the minimization of X-ray and dye exposure.

Baseline heart rate variability predicts clinical events in heart failure patients implanted with cardiac resynchronization therapy: validation by means of related complexity index.

BACKGROUND: Studies on the physiology of the cardiovascular system suggest that generation of the heart rate (HR) signal is governed by nonlinear dynamics. Linear and nonlinear indices of HR variability (HRV) have been shown to predict outcome in heart failure (HF). Aim of the present study is to assess if a HR-related complexity predicts adverse clinical and cardiovascular events at 1 year in patients implanted with cardiac resynchronization therapy (CRT). METHODS: In sixty patients implanted with CRT (Renewal), 24-hour HR data were retrieved at patient discharge and 1-year follow-up. A set of linear indices of HRV were considered: mean HR, standard deviation of normal beat to normal beat (SDANN), and HR footprint. Two novel nonlinear indices were calculated by means of a specific algorithm (OntoSpace): HR-complexity (HR-Co) and HR-entropy (HR-En). Predictors of adverse clinical outcome (functional class deterioration or major hospitalizations for cardiovascular causes or all-cause mortality) and of HRV recovery were sought by means of multivariate analysis. RESULTS: HR-Co and HR-En were found to be highly correlated with the other traditional indices of HRV. Lower baseline values of COMPLEXITY WERE ASSOCIATED WITH ADVERSE CLINICAL OUTCOMES (HAZARD RATIO [HR] 0.71; 95% CONFIDENCE INTERVAL [CI] 0.54-0.95; P < 0.02). CONCLUSION: Complexity and entropy indices, calculated from 24-hour normal beat to normal beat (RR) intervals well represent patient's autonomic function. In this limited set of data, HF patients with lower baseline complexity-related indices, representing a more compromised autonomic function, present worse clinical outcome at 1-year follow-up.

Diagnostic value of endomyocardial biopsy guided by electroanatomic voltage mapping in arrhythmogenic right ventricular cardiomyopathy/dysplasia.

UNLABELLED: Voltage Mapping-Guided Biopsy in ARVC/D. INTRODUCTION: To improve the endomyocardial biopsy (EMB) diagnostic sensitivity for arrhythmogenic right ventricular cardiomyopathy/dysplasia (ARVC/D), we hypothesized a biopsy sampling focused on selected right ventricle (RV) low-voltage areas identified by electroanatomic voltage mapping. METHODS AND RESULTS: The study population (22 patients, 10 men; mean age 34 +/- 10 years) included 11 patients with overt ARVC/D (group A) and 11 patients with suspected ARVC/D (group B), according to both arrhythmic profile and standardized noninvasive diagnostic criteria. In all 22 patients, an RV bipolar voltage mapping was performed with CARTO system sampling multiple endocardial sites (262 +/- 61), during sinus rhythm, with a 0.5-1.5 mV color range setting of voltage display. All 11 (100%) group A patients and 8 of the 11 (73%) group B patients (P = nonsignificant [NS]) presented RV low-voltage areas (<0.5 mV). In 8 group A patients and in all 8 group B patients with a pathological RV voltage map, an EMB focused on the low-voltage areas was performed. In 6 (75%) group A patients and in 7 (87%) group B patients (P = NS), voltage mapping-guided EMB was diagnostic for ARVC/D. In the remaining 3 patients, only nonspecific histological findings were observed. CONCLUSIONS: The results of our study (1) confirm the high diagnostic sensitivity of RV voltage mapping in patients with overt ARVC/D, (2) document a high prevalence of RV low-voltage areas even in patients with suspected ARVC/D, and (3) demonstrate that in patients with clinical evidence or suspicion for ARVC/D, presenting RV low-voltage areas, EMB guided by voltage mapping may provide ARVC/D diagnosis confirmation.

Fossa ovalis radiofrequency perforation in a difficult case of conventional transseptal puncture for atrial fibrillation ablation.

A 65-year-old man was referred for atrial fibrillation ablation to our center. Routine pre-procedure transthoracic and transoesophageal echocardiography and cardiac computed tomography examinations showed a normal interatrial septum and fossa ovalis anatomy. Access to left atrium was initially planned using a conventional transseptal needle puncture. During the procedure, several consecutive attempts in conjunction with intracardiac echocardiography support, failed to cross the septum. The procedure was then successfully carried out using a specifically designed radiofrequency transseptal catheter.

Endomyocardial biopsy guided by electroanatomic voltage mapping in arrhythmogenic right ventricular cardiomyopathy: a case report.

A positive endomyocardial biopsy (EMB) is a major diagnostic criterion for arrhythmogenic right ventricular cardiomyopathy (ARVC). Nevertheless, its sensitivity is low due to the focal nature of the disease. Moreover, myocardial samples are usually taken from the uncommonly involved interventricular septum to minimize the risk of perforation. In this report, we describe a novel bioptical approach for ARVC diagnosis guided by the identification of right ventricle (RV) affected regions by means of electroanatomical voltage mapping.

Safety and feasibility of coronary sinus left ventricular leads extraction: a preliminary report.

BACKGROUND: transvenous positioning of the left ventricular (LV) lead in a branch of the coronary sinus (CS) is generally the preferred implantation technique in biventricular pacing. Very few data are reported about removal of LV pacing leads positioned in a CS branch. Aim of the study was to describe our experience with percutaneous extraction of LV pacing leads in order to evaluate feasibility and safety of this procedure. METHODS: we enrolled 392 patients who underwent a biventricular pacing implant. The indication for catheter removal was considered in case of definite diagnosis of infection and in some cases of lead dislodgement or diaphragmatic stimulation. LV lead extraction was first attempted by manual traction; in case of failure a locking stylet or locking stylet plus radiofrequency could be used. RESULTS: twelve of 392 patients implanted needed LV lead removal. The leads had been in place for 13.9 +/- 11.7 months. Extraction was indicated in 5 of them for LV lead dislodgement or diaphragmatic stimulation, and in 7 patients for lead infection. In all cases manual traction succeeded to remove the LV lead. In 7 cases of infection, the right atrial and ventricular leads were removed. The mean total procedure time was 69 +/- 22 min. No complications were observed. CONCLUSIONS: our study suggests that CS leads could be easily and safely removed without any complication, also when placed in a CS branch, at least for relatively young catheters.

Differences in heart rate turbulence between patients with coronary artery disease and patients with ventricular arrhythmias but structurally normal hearts.

The term "heart rate turbulence" (HRT) indicates the physiologic changes in the sinus cycle that follow a ventricular premature complex; impaired HRT denotes abnormalities in cardiac autonomic function. To investigate whether HRT is impaired in patients with stable coronary artery disease (CAD), we studied 29 patients with documented CAD and frequent (>/=30/hour) ventricular premature complexes on Holter monitoring and 31 patients with frequent ventricular arrhythmias but normal hearts (NH-VA). HRT and heart rate variability analyses were analyzed on 24-hour Holter recordings. HRT variables differed significantly between the 2 groups (turbulence onset -0.20 +/- 1.7% vs -0.67 +/- 2.2%, p = 0.00001; turbulence slope 2.83 +/- 1.9 vs 10.83 +/- 7.4 ms/RR, p = 0.0001 in patients with CAD and NH-VA, respectively). The difference was independent of a history of previous myocardial infarction, left ventricular function, and age. Top quartile turbulence onset values (>-0.26%) and bottom quartile turbulence slope values (<2.12 ms/RR) had similar predictive power in discriminating between patients with CAD and NH-VA (positive predictive value 86.7%, negative predictive value 64.4% for both). Among heart rate variables, bottom quartile SD of all RR intervals values (<96.3 ms) only had the same power of HRT variables in discriminating between patients with CAD and NH-VA. Thus, our data show that HRT variables are impaired in patients with CAD patients versus those with NH-VA, indicating abnormalities in the control of short-term cardiac autonomic mechanisms resulting in decreased vagal activity with likely predominant sympathetic activity.

A randomized comparison of alternative techniques to achieve coronary sinus cannulation during biventricular implantation procedures.

INTRODUCTION: Biventricular pacing system implantation is a time-consuming and challenging procedure. A critical step in biventricular pacemaker implantation is coronary sinus (CS) cannulation. CS cannulation can be achieved either using dedicated guiding catheters (guiding catheter alone positioning strategy, GCA) or with the aid of an electrophysiology catheter advanced inside the guiding catheter (electrophysiology catheter aided positioning strategy, EPA). AIM OF THE STUDY: To evaluate whether the EPA technique is useful for reducing CS cannulation time compared to a conventional GCA technique. METHODS: Thirty-four consecutive patients were randomly assigned to the GCA (18 patients) or EPA (16 patients) CS cannulation strategy. RESULTS: Time to successful catheterization of CS was 5.0 +/- 2.4 min in the EPA group versus 10.1 +/- 5.4 min in the GCA group p = 0.004. Fluoroscopy time was 4.6 +/- 2.3 min in the EPA group versus 9.2 +/- 4.9 min in the GCA group p = 0.004. Total contrast dye volume to search and engage the CS ostium was 0.0 ml in the EPA group versus 14.3 +/- 3.4 ml in the GCA group p < 0.001. CONCLUSIONS: Cannulation of CS with the adjunct of an electrophysiology catheter to dedicated delivery systems significantly reduces procedural time, fluoroscopy time and contrast dye volume compared to a conventional strategy.

The linear ablation of atrial fibrillation in the right atrium: can the isthmus ablation improve its efficacy?

OBJECTIVES: The aims of this study were to compare the efficacy of a 2- versus a 3 RF lesions ablation procedure in the RA in patients with paroxysmal AF, and to map right atrial activation during AF. BACKGROUND: RF catheter-mediated ablation lines mimicking the Maze operation have been proposed as a novel curative approach for AF. The relationship between this type of ablation and right atrial mapping has not been extensively studied. METHODS: Twenty-four patients with recurrent, drug-refractory, paroxysmal AF underwent an extensive mapping of the RA before attempting linear lesion RF ablation. Patients were divided into two groups: 15 patients received two linear lesions (Group 1), 9 patients three linear lesions (Group 2). RESULTS: One-month success rate AF did not recur in 40% of Group 1 patients (6/15) and in 66% (6/9) of Group 2 patients. 27% of patients in Group 1 and 11% of patients in Group 2 had recurrences controlled by drugs. No benefit in 33% of Group 1 patients and 22% of Group 2. Long-term follow-up In the absence of any drug treatment, no AF recurrences were observed in 26% of Group 1 patients (FU: 23 to 47 months) and 55% of Group 2 (FU: 14 to 23 months). No complications were reported. CONCLUSIONS: Right atrial linear ablation is safe and may be proposed for AF treatment in selected patients.

Lead extraction: a new effective tool to overcome fibrous binding sites.

We report the case of a 50 year-old woman referred for extraction of an infected biventricular implantable cardioverter defibrillator (ICD) who underwent device and leads extraction. Due to adhesions at the level of the subclavian-innominate vein angle, manual traction with locking stylet was ineffective. A new mechanical sheath provided with a stainless steel bladed tip, the Evolution Mechanical Dilator Sheath (Cook Medical), was successfully used to complete lead extraction. As far as we know, this is the first report on the use of this new tool; its safety should be ascertained by increasing the number of cases but its simple use and its low cost make the Evolution Mechanical Dilator Sheath a new interesting tool that can be added to the instruments available for lead extraction.

Right ventricular substrate mapping using the Ensite Navx system: Accuracy of high-density voltage map obtained by automatic point acquisition during geometry reconstruction.

BACKGROUND: Contact point-to-point electroanatomic mapping (Pt-Map) is a validated tool to evaluate right ventricular (RV) substrate. When using the EnSite NavX system (St. Jude Medical, St Paul, Minnesota), geometry reconstruction by dragging the mapping catheter (Geo-Map) allows for quicker acquisition of a large number of points and better definition of anatomy, but it is not validated for substrate mapping. OBJECTIVE: This study evaluates the feasibility and accuracy of Geo-Map. METHODS: Thirteen patients (mean age 38 +/- 12 years) with RV arrhythmias and an apparently normal heart underwent cardiac magnetic resonance imaging (MRI), Pt-Map, and Geo-Map. The 2 maps were compared in terms of mapping procedural time, radiation time, and total number of points acquired. We finally compared the number and characteristics of low-potential areas on each patient's Pt-Map, Geo-Map, and cardiac MRI. RESULTS: Geo-Map required significantly shorter mapping and radiation times in comparison to Pt-Map (12.4 +/- 4.6 vs. 31.9 +/- 10.1 and 5.8 +/- 2.1 vs. 12.1 +/- 3.9, P <.001). Furthermore, Geo-Map was based on a significantly higher density of points in comparison to Pt-Map (802 +/- 205 vs. 194 +/- 38, P <.001). Taking into consideration the total number of RV regions analyzed, the Pt-Map and Geo-Map disagreed in 2 of 65 (3%) regions (P = NS), which only Geo-Map identified as low-potential areas and indeed corresponded to wall motion abnormalities on MRI. CONCLUSION: Voltage maps obtained through RV geometry acquisition have accuracy comparable to that of conventional point-by-point mapping in detecting low-voltage areas, have a good correlation with MRI wall motion abnormalities, and allow a significant reduction in procedural time and x-ray exposure.

Widespread electroanatomic alterations of right cardiac chambers in patients with myotonic dystrophy type 1.

INTRODUCTION: Conduction disturbances and arrhythmias characterize the cardiac feature of myotonic dystrophy type 1 (MD1); a myocardial involvement has been suggested as part of the cardiac disease. The aim of our study was to investigate the underlying myocardial alterations using electroanatomic mapping (CARTO) and their possible correlation with genetic and neurological findings. METHODS AND RESULTS: Right atrial and ventricular CARTO maps were obtained in 13 MD1 patients. Thirteen age-matched patients with paroxysmal supraventricular tachycardia and normal heart served as controls. Unipolar voltage (UNI-v), bipolar voltage (BI-v) amplitudes, bipolar potential duration (Bi-dur), and atrial propagation time (A-pt) were measured. UNI-v and BI-v in interatrial septum, anterolateral atrial wall, and right ventricle outflow tract were lower in MD1 patients than controls (P < 0.001). Bi-dur and A-pt were longer in MD1 patients than controls (P < 0.001, P = 0.046, respectively). A significant relationship was documented between CTG triplets and the percentage of Bi-v <0.5 mV in the atrial anteroseptal region (r = 0.6, P = 0.02). CONCLUSIONS: Altered electroanatomic patterns are present in the right cardiac chambers in MD1 patients. Widespread myocardial alterations, not necessarily limited to the conduction system, may support the presence of a cardiac myopathy as part of the disease.

Heart rate turbulence as a noninvasive risk predictor of ventricular tachyarrhythmias in myotonic dystrophy type 1.

INTRODUCTION: Myotonic dystrophy type 1 (MD1) is the most common muscular dystrophy of adult life. Cardiac involvement is characterized by disorders of atrioventricular conduction, ventricular arrhythmias, and sudden death. Heart rate turbulence (HRT) is a noninvasive risk predictor in patients affected by ischemic heart disease. The aim of our study is to assess the prognostic value of HRT in MD1 patients. METHODS AND RESULTS: We performed HRT analysis by 24-hour Holter recording to calculate turbulence onset (TO) and turbulence slope (TS) in 29 MD1 patients (mean age 52 +/- 10 years), and in 30 patients (mean age 52 +/- 13 years) with frequent ventricular arrhythmias and structurally normal heart (VANH). An electrophysiological study (EPS) tested ventricular arrhythmias inducibility in 22 MD1 patients. TO was significantly different between MD1 and VANH patients (-1.66 +/- 2.04 and -2.98 +/- 1.79%, respectively, P 0.01), while no difference was observed in TS between MD1 and VANH patients (11.12 +/- 6.46 and 9.12 +/- 6 msec/beat, respectively). On EPS, sustained ventricular arrhythmias (SVA) were induced in six MD1 patients. TO was significantly different in inducible MD1 patients (0.88 +/- 1.95%), as compared with both noninducible (-2.49 +/- 1.43%, P < 0.001) or no eligible to EPS (-1.93 +/- 1.63%, P < 0.005) MD1 patients and to VANH patients (-2.98 +/- 1.79%, P < 0.001). CONCLUSIONS: An impairment of TO, a measure of HRT, suggesting impaired cardiac parasympathetic activity, may be a useful, noninvasive predictor of arrhythmic risk in MD1 patients.

A randomized evaluation of different approaches to coronary sinus venography during biventricular pacemaker implants.

AIM: Biventricular implantation procedures require contrast venography of the coronary sinus. The aim of our study was to evaluate the efficacy and safety of contrast venography obtained by direct manual contrast injection into the guiding catheter, compared with venography obtained after occlusion of the coronary sinus by a Swan-Ganz catheter. METHODS: Eighty-three patients were randomly assigned to direct or occlusive venography technique. The primary endpoint was complication rate. The secondary endpoints were rate of and time required for an adequate venography, total dose of contrast medium and total procedure time. RESULTS: Four dissections of the coronary sinus were observed with the occlusive venography technique group while no complications were observed with the direct venography technique group (p=0.04). Rate of adequate venography was similar in the two groups (p=NS). The time needed for coronary sinus venography and the total dose of contrast medium was significantly lower in the direct venography technique group compared with the alternative (p<0.0001 and p=0.003, respectively); the total procedure time was not significantly different between the two groups (p=NS). CONCLUSIONS: The direct venography technique shows a significantly lower incidence of complications and should be considered to be the first line approach to coronary sinus venography during biventricular pacemaker implantation.