Systematic fluoroscopic and electrical assessment of implantable cardioverter-defibrillator patients implanted with silicone-polyurethane copolymer (Optim™) coated leads.

AIMS: Serious concerns have been recently raised about the reliability of the silicone-polyurethane copolymer (Optim™) lead insulation system. We sought to identify insulation defects and Optim-lead failures by systematic fluoroscopic and electrical assessment in a prospectively defined cohort of implantable cardioverter-defibrillator (ICD) patients. METHODS AND RESULTS: Between July 2007 and December 2011, 234 patients were implanted with 413 optim-coated leads as part of an ICD system at a single centre. Fluoroscopic screening with high-resolution cine-fluoroscopy at 30 frames per second was offered to all patients. In addition, the electrical integrity of all implanted leads was assessed. Durata, Riata ST Optim, and low-voltage Optim leads were implanted in 199, 26, and 188 cases, respectively. During a total follow-up of 10 036 lead-months, there were 7 Optim-lead failures (defined as electrical malfunction resulting in lead replacement) and 31 deaths; no cases of electrical noises were encountered. The overall incidence of lead failure was 1.2 vs. 0.3 per 100 lead-years, for high- and low-voltage leads, respectively (P = 0.1). One hundred fifty-one patients agreed to undergo fluoroscopy screening; none of the 264 analysed Optim leads were found to have any fluoroscopically visible structural defects after an average of 31 months post-implant. CONCLUSION: This study represents the first systematic screening of Optim-coated leads in a large unselected cohort of ICD patients. Over a 5-year period few lead failures were observed and normal fluoroscopic appearance was present in all patients.

A novel methodology for AV and VV delay optimization in CRT: results from a randomized pilot clinical trial.

The aim of this work was to determine whether the use of a newly developed methodology (Alg1) for AV and VV optimization improves cardiac resynchronization therapy (CRT) clinical and echocardiographic (ECHO) outcomes. In this single-center pilot clinical trial, 80 consecutive patients (79 % male; 70.1 ± 11.2 years) receiving CRT were randomly assigned to AV and VV optimization using Alg1 (group A) or standard commercial procedures (group B). Clinical status and ECHOs were analyzed at baseline (_0) , 3 (fu1), and 6 months (fu2) of follow-up evaluating left ventricular end systolic (LVESV) and end diastolic (LVEDV) volumes, ejection fraction (EF), Minnesota test, and 6-min walk test (6MWT). Alg1 is based on a cardiovascular model fed with patient data. Baseline characteristics did not differ significantly between groups. Group A had a better clinical outcome and reverse remodeling. Remodeling was calculated as the difference (Δ) between fu1 and _0 and between fu2 and fu1, respectively: [LVESV (ml): ΔA_fu1 = -55.3, ΔB_fu1 = -13.5, p_fu1 = 0.002; ΔA_fu2 = -22.8, ΔB_fu2 = 3.0, p_fu2 = 0.04], [LVEDV (ml): ΔA_fu1 = -61.9, ΔB_fu1 = -16.1, p_fu1 = 0.01; ΔA_fu2 = -30.4, ΔB_fu2 = 11.3, p_fu2 = 0.02]; Minnesota test: total (p_fu1 = 0.01; p_fu2 = 0.04), physical (p_fu1 = 0.01; p_fu2 = 0.03) and emotional scores (p_fu1 = 0.04; p_fu2 = 0.03) and in 6MWT (m) (p_fu2 = 0.008). No statistically significant difference was observed in QRS width. Compared with current standard of care, CRT optimization using Alg1 is associated with better outcomes, showing the power of a tailored CRT.

An unusual case of iatrogenic Twiddler's syndrome.

: Twiddler's syndrome is an uncommon cause of cardiac implantable electronic device malfunction, usually due to manipulation of the pulse generator. A few spontaneous cases have already been described. We present the unique case of a 77-year-old woman who experienced iatrogenic Twiddler's syndrome.

Distribution and prognostic significance of QT intervals in the lowest half centile in 12,012 apparently healthy persons.

The presence of an abnormally short QT interval has been noted among survivors of idiopathic ventricular fibrillation and among close relatives of victims of unexplained sudden death. Most reported cases have had rate-corrected QT (QTc) intervals of <300 ms. The prevalence of such values in the community has not been documented. We reviewed the electrocardiograms (ECGs) of 12,012 subjects who underwent routine medical examinations for occupational reasons. The QT interval was measured by 2 physicians in all cases, and QTc interval was calculated. All ECGs with QTc values in the lowest 5% were reviewed by 2 cardiologists expert in QT analysis, and the QT measurement was corrected if necessary. Information about subsequent survival was obtained from the case file or from public records. In the lowest 1/2 centile, the distribution of QTc values continued to follow a normal pattern without evidence of a distinct subpopulation of low values. The shortest QTc encountered was 335 ms. Information about subsequent survival was available for 36 of the 60 subjects with the lowest 1/2 centile of QTc values. None of these subjects died during the 7.9 +/- 4.5 years subsequent to the ECG that demonstrated the short QT interval. In conclusion, a QTc interval of

Effects of carbon-coated coronary stents on the markers of inflammation, thrombin generation and platelet and endothelial activation.

BACKGROUND: The effects of stent carbon coating on the activation of inflammatory and endothelial cells and of coagulation were assessed in patients undergoing coronary artery stent implantation. METHODS: Forty-four consecutive patients with stable angina and an isolated significant stenosis in a native coronary vessel undergoing stent implantation were randomized to a carbon-coated stent (Carbostent, n = 23) or an uncoated stent with a similar design (Multilink, n = 21). The markers of inflammation, of hemostasis and of platelet and endothelial activation were determined before and 6, 24, 48 and 72 hours after the procedure. RESULTS: Procedural success was achieved in all cases and no patient presented with major in-hospital adverse events. In both the Carbostent and Multilink groups, the median (interquartile range) plasma levels of C-reactive protein significantly increased after the procedure (p < 0.001 and p = 0.002 vs baseline levels, respectively), reaching a peak at 48 hours, without any difference between groups (p = 0.76). Similarly, in both groups the plasma levels of fibrinogen, thrombin-antithrombin III complexes, prothrombin fragments F1 + 2, plasminogen activator inhibitor-1, soluble E-selectin, soluble P-selectin and von Willebrand factor significantly increased after the procedure (all p < 0.05 vs baseline values), without any difference between groups (all p = NS). CONCLUSIONS: This study confirms that the markers of inflammation, of endothelial and platelet activation and of thrombin generation significantly increase after successful coronary artery stent implantation. More importantly, it demonstrates that carbon coating does not modify the biologic response of the vessel wall to stent implantation.

Work burden with remote monitoring of implantable cardioverter defibrillator: is it time for reimbursement policies?

AIMS: The efficacy and accuracy, as well as patients' satisfaction, of device remote monitoring are well demonstrated. However, the workload of remote monitoring management has not been estimated and reimbursement schemes are currently unavailable in most European countries. This study evaluates the workload associated with remote monitoring systems. METHODS: A total of 154 consecutive implantable cardioverter defibrillator patients (age 66±12 years; 86.5% men) with a remote monitoring system were enrolled. Data on the clinician's workload required for the management of the patients were analyzed. RESULTS: A total of 1744 transmissions were received during a mean follow-up of 15.3±12.4 months. Median number of transmissions per patient was 11.3. There were 993 event-free transmissions, whereas 638 transmissions regarded one or more events (113 missed transmissions, 141 atrial events, 132 ventricular episodes, 299 heart failure-related transmissions, 14 transmissions regarding lead malfunction and 164 transmissions related to other events). In 402 cases telephonic contact was necessary, whereas in 68 cases an in-clinic visit was necessary and in 23 of them an in-clinic visit was prompted by the manufacturer due to technical issues of the transmitter. During follow-up, 316 work hours were required to manage the enrolled patients. Each month, a total of 14.9 h were spent on the remote monitoring of 154 patients (9.7 h for 100 patients monthly) with approximately 1.1±0.15 h per year for each patient. CONCLUSION: The clinician's work burden is high in patients with remote monitoring. In order to expand remote monitoring in all patients, reimbursement policies should be considered.

Predictive value of fragmented QRS in primary prevention implantable cardioverter defibrillator recipients with left ventricular dysfunction.

INTRODUCTION: In primary prevention implantable cardioverter defibrillator (ICD) patients, the incidence of appropriate ICD therapy is relatively low, prompting better risk stratification. Fragmented QRS (fQRS) on a 12-lead ECG has been associated with adverse outcomes. The aim of this study was to evaluate the prognostic value of fQRS in ICD recipients. METHODS: Consecutive ICD patients implanted at our institution for primary prevention of sudden cardiac death (SCD) were retrospectively evaluated. Patients were divided in two groups based on the presence or the absence of fQRS on the ECG obtained before ICD implantation. The endpoint of the study was all-cause mortality or the occurrence of any appropriate ICD-delivered therapy, whether shock or antitachycardia pacing. RESULTS: Among 394 ICD recipients (334 men, age 66.4  ±  11.0), fQRS was observed in 103 patients (26.1%). There were 189 patients (48.0%) with wide QRS at the time of implantation. Among these patients, fQRS was found in 29 individuals (28.2%). Patients in fQRS(+) group were more likely to have coronary artery disease and a lower QRS duration than those without fQRS. During a mean follow-up of 26.3  ±  17.5 months, mortality or ICD therapy were 19.4 and 22.4%, respectively, for fQRS(+) patients, and 15.2 and 22.8% for fQRS(-) patients (P = NS). By Kaplan-Meier analysis, event-free survival was similar in the two groups. CONCLUSION: In ICD recipients for primary prevention of SCD, fQRS is not helpful in selecting a subgroup of patients who benefit from prophylactic ICD implantation.

Safety and efficacy of a new magnetic resonance imaging-compatible pacing system: early results of a prospective comparison with conventional dual-chamber implant outcomes.

BACKGROUND: A new pacing system has been designed and tested preclinically for safe use in the magnetic resonance imaging (MRI) environment. Experience with this innovative system has not yet been reported. OBJECTIVE: The purpose of this study was to verify the safety and effectiveness of this newly designed system compared to conventional DDD implant outcomes. METHODS: Over an 11-month period, 107 consecutive patients (71 men and 36 women; age 72.6 +/- 8.5 years) were implanted with either the MRI system (n = 50; MRI group) or a dual-chamber, active-fixation lead (Medtronic 4076) non-MRI system (n = 57; DDD group). Data were collected at implant and during postoperative follow-up at 1, 3, 6, and 12 months. Procedural and fluoroscopic times at implant, as well as lead measurements, handling characteristics, and procedural-related complications, were prospectively analyzed. RESULTS: The implantation success rate in both groups was 100%. Cephalic access was 63% for MRI patients and 70% for DDD patients (P = NS). Follow-up was obtained for all patients (median 6.8 months, range 3-12 months). At implant and at the end of follow-up, stimulation thresholds, sensing, and impedance were acceptable. No cases of high pacing thresholds or inadequate sensing were noted. No complications occurred, and no patient experienced subsequent lead displacement. CONCLUSION: This prospective, controlled study provides strong evidence that the feasibility and safety of this novel technology compare favorably with those of the conventional technique.

Prevalence and significance of Brugada-type ECG in 12,012 apparently healthy European subjects.

BACKGROUND: The prevalence of the Brugada-type ECG and its natural history are still unclear. The recently proposed diagnostic criteria have not been systematically applied in a European general population. METHODS: We retrospectively analyzed ECGs and clinical data of 12,012 apparently healthy individuals who had undergone medical examination for occupational reasons. We sought follow-up information on the subjects with at least one ECG fulfilling the criteria for the Brugada pattern. RESULTS: A Brugada-type ECG was found in 23 subjects (0.19%; 95% confidence interval 0.12-0.27%) on the first ECG recorded in that subject. In a further 8 cases, the Brugada pattern was present in a subsequent ECG, so that it was present at some time in 31 subjects (0.26%, 95% confidence interval 0.18-0.37%), all male. Only 2 patients displayed the classical type 1 Brugada ECG pattern. In 29 patients (94%), clinical information was available subsequent to the first Brugada pattern ECG recorded. The mean follow-up was 10.1+/-5.5 years. A sudden death occurred in a 27-year-old man with Brugada type 2 ECG pattern. No sudden death or symptomatic ventricular arrhythmia occurred among the other 28 patients. The annual rate of sudden death associated with Brugada ECG pattern was 0.3% per patient-year of follow-up. CONCLUSION: The Brugada-type ECG pattern, as currently defined, is uncommon in a young healthy male European population and confers a moderately elevated risk of sudden death. Our findings underscore the need to study risk predictors in asymptomatic patients with a Brugada-type ECG.

Appropriateness of ECG Holter requests in an outpatient service: a prospective study.

BACKGROUND: Electrocardiographic ambulatory ECG monitoring plays a central role in the diagnostic evaluation of patients with cardiac arrhythmias. We sought to evaluate the appropriateness of the prescription of ECG Holter recordings performed at our centre. METHODS: We interviewed 2489 consecutive patients (49% male, aged 61 +/- 32 years) undergoing ECG Holter. We recorded the indication for the examination, the clinical characteristics of the patient and the speciality of the prescribing physician. The appropriateness of the test was evaluated. RESULTS: We evaluated 2489 consecutive Holter recordings, of which 1298 (52%) were found to have been clearly appropriate (class I), 311 (13%) as probably or possibly appropriate (class II), and 880 (35%) as inappropriate (class III). The test was requested by a cardiologist in 776 cases (31%), of which 56.2% had a class I indication, 13.4% class II, and 30.4% class III. Tests requested by a non-cardiologist were clearly appropriate (class I) in 50% of cases, whereas 12% had a class II indication, and 38% were in class III. Supraventricular tachycardia was present in 33.4% of recordings with a class I indication, 9% of those in class II, and 57.6% of those in class III. Non-sustained ventricular tachycardia was present in 6% of those with class I indications, 2.6% of those in class II, and 7.4% of those in class III. CONCLUSION: Our data showed that the majority of Holter recordings prescribed in our region are appropriate. Tests prescribed by cardiologists constitute only 31% of the total volume, but are more often appropriately prescribed.

Coronary spasm: a case of transient ST elevation and syncopal ventricular tachycardia without angina.

We report the case of a 60-year-old male with recurrent pre-syncope, referred with a provisional diagnosis of carotid sinus syndrome on the basis of a 4 s asystolic pause following carotid sinus massage. On repeat Holter monitoring there was ST-segment elevation followed by episodes of polymorphic ventricular tachycardia during a mild episode of pre-syncope. Coronary angiography showed mild right coronary artery irregularity without significant stenosis. An automatic cardioverter defibrillator was implanted and high dose combined vasodilator therapy was commenced. At follow-up 18 months after implantation, the device has recorded no episode of tachycardia and the patient reports no recurrence of symptoms.

Feasibility and safety of a simplified draping method for pacing procedures.

AIMS: Traditional draping for pacing procedures is time-consuming. We evaluated prospectively the safety of a simplified method using a single adhesive drape intended for use in cardiac catheterization. METHODS AND RESULTS: A single disposable adhesive drape was used in each of 250 consecutive pacing procedures by the same operator including 200 device implants and 50 revision procedures. We compared the results with those of 114 procedures performed in the same cardiac catheterization laboratory by three other operators using traditional draping methods for most cases. In the study group, no wound or pacemaker pocket infection, device erosion, or endocarditis was observed within the first 6 months after the procedure (0%, 95% CI 0-1.2%). One suspected infection occurred at 10 months (0.4%, 95% CI 0.1-2.2%). In the control group, there were two cases of early infection or suspected infection (2 of 114 procedures, 1.8%, 95% CI 0.27-6.1%), four cases of confirmed or suspected infection more than 6 months after the procedure giving an overall infection rate (6 of 114, 5.3%, 95% CI 2.1-11.0%) significantly higher than in the study group (P = 0.014, Fisher's exact test). CONCLUSION: A simplified draping method involving a single adhesive fenestrated drape can be used for pacemaker or ICD implantation or revision procedures without an excessively elevated risk of infective complications.