The Psychological Impact of Implantable Cardioverter-Defibrillator Recalls and the Durable Positive Effects of Counseling

Background: It is known that patients with lifesaving devices such as implantable cardioverter-defibrillators (ICDs) may be alarmed and worried by recalls or alerts related to their ICDs.
Objectives: This study aimed to determine whether counseling has any short- or long-term benefits, and to look for characteristics that identify those most worried and those most in need of counseling.
Methods: Among 100 patients with recall or alert ICDs, 14 were pacer dependent; 50 had ICDs for 1° prevention and 22 were women. Patients completed a survey indicating how worried they were on learning of the recall or alert (0–10 scale). After counseling and advice in accordance with manufacturer guidelines, patients were asked to indicate their level of worry, and were again asked after 6 months.
Results: For all patients, the "worry level" at the initial interview was 5.0 ± 3.7, falling to 2.2 ± 3.0 after counseling (P < 0.001) and 1.4 ± 2.3 after 6 months (P < 0.001 vs both earlier levels). There were no significant differences between those implanted for 1° versus 2° prevention or for pacer dependency. Women were initially more worried than men, but not for the long term. The 49 patients whose ICDs could be managed by reprogramming or software fix had significant reduction in worry after counseling and at 6 months compared to others. The 18 patients recommended for operative intervention remained more concerned after counseling (3.5 ± 3.3 vs 1.9 ± 2.9, P = 0.043).
Conclusions: Patients' concerns resulting from ICD recalls or alerts can be reduced by appropriate counseling. Those patients whose ICDs could be reprogrammed to safer parameters had the most reduction in worry levels.     

Differential Effect of Biventricular and Right Ventricular DDD Pacing on Coronary Flow Reserve in Patients With Ischemic Cardiomyopathy

CRT and Coronary Flow Reserve. Background: Cardiac resynchronization therapy (CRT) has become a mainstay in heart failure management. There are also indications that upgrading of existing pacemakers to CRT systems may be of benefit. The aim of this study was to assess the effect of biventricular (BiV), compared with right ventricular (RV), pacing, on coronary flow reserve (CFR), in patients with ischemic cardiomyopathy. Methods and Results: From our database of heart failure patients implanted with BiV pacemakers, 20 patients (10 responders and 10 non‐responders to CRT) were randomly selected. Left anterior descending artery coronary flow reserve was measured invasively, under BiV and RV pacing, using intracoronary adenosine to induce hyperemia. In all the 20 patients, there was a significant difference in the pairwise comparison between CFR recorded during BiV and RV pacing (mean difference 0.15, 95% confidence interval 0.07–0.23, P = 0.001). When comparing responders to non‐responders, there was a significant difference as to the effect of BiV, compared with RV, pacing on CFR: mean difference (BiV minus RV CFR) was 0.26 ± 0.06 (95% confidence interval 0.13–0.39; P = 0.002), while in non‐responders the difference was 0.04 ± 0.03 (95% confidence interval ?0.02 to 0.10; P = 0.168). Conclusion: BiV pacing is overall associated to higher CFR, compared with RV DDD pacing. This difference is almost exclusively attributable to the beneficial effect of CRT on coronary flow reserve in CRT‐responders. This effect may contribute to the beneficial action of resynchronization in the failing heart and can be viewed in the context of reports of the usefulness of upgrading RV pacemakers to CRT systems. (J Cardiovasc Electrophysiol, Vol. 21, pp. 1233‐1239, November 2010)     

A RANDOMIZED CONTROLLED TRIAL TO ASSESS THE INCIDENCE OF NEW ONSET HYPERTENSION IN PATIENTS AFTER SHOCK WAVE LITHOTRIPSY FOR ASYMPTOMATIC RENAL CALCULI

Purpose

To answer the question of whether extracorporeal shock wave lithotripsy (ESWL*) induces hypertension, a prospective, randomized controlled trial of normotensive patients with asymptomatic renal calculi was designed.

Materials and Methods

Patients were randomized to receive immediate ESWL versus observation, reserving ESWL for the onset of symptoms. The rates of new onset hypertension were evaluated for both groups.

Results

There was no observed difference in the incidence of hypertension between the treatment and observation groups.

Conclusions

The risk of hypertension in patients undergoing ESWL therapy is similar to that of a control cohort of initially observed asymptomatic patients.     

Drug Delivery at the Aortic Valve Tissues of Healthy Domestic Pigs with a Paclitaxel-Eluting Valvuloplasty Balloon

Background: Restenosis occurs invariably within 1 year following balloon valvulopasty in aortic valve stenosis. The mechanism of restenosis seems to involve a dynamic cellular component that could be a target for drug inhibition. We investigated the feasibility of local drug delivery at the aortic valve tissues of healthy pigs with a paclitaxel-eluting balloon.
Methods: Aortic valvuloplasty was performed in eight anesthetized domestic pigs using paclitaxel-eluting balloons (3 μg/mm² balloon surface area). They were assigned to two or four times 15-second balloon inflations and were sacrificed 30 minutes after final balloon inflation.
Results: The aortic annulus to balloon diameter ratio was 1.15 ± 0.07. The mean paclitaxel concentration in the aortic valve leaflets was 0.91 ± 1.36 μg/mL (0.34 ± 0.05 μg/mL in the two-inflation group, 1.48 ± 1.86 μg/mL in the four-inflation group, P = 0.23). The percentage of the total paclitaxel dose recovered in the aortic valve leaflets was 18 ± 11⁻⁶% (13 ± 6⁻⁶% and 25 ± 14⁻⁶% in the two- and four-inflation group, P = 0.16).
Conclusion: Local drug delivery at the aortic valve leaflets of healthy pigs with a paclitaxel-eluting balloon is feasible and concentrations within the therapeutic window are detected 30 minutes after the procedure. The antirestenotic potential of this treatment should be studied.     

Predictors of Atrial Tachyarrhythmias in Subjects with Type 1 ECG Pattern of Brugada Syndrome

Background: Previous studies have demonstrated a high incidence of atrial tachyarrhythmias (ATs) in patients with Brugada syndrome (BS). The present study aimed to investigate whether various 12-lead electrocardiogram (ECG) and electrophysiological parameters may help to differentiate subjects with a high probability to develop ATs.
Methods and Results: The clinical records of 38 individuals (31 males, age 44.4 ± 13.9) with spontaneous (n = 15) or ajmaline-induced (n = 23) type 1 ECG pattern of BS were analyzed. During a mean follow-up period of 4.6 ± 2.2 years, nine subjects suffered ATs (24%). Six subjects displayed paroxysmal atrial fibrillation and three typical atrial flutter. Among the studied 12-lead ECG parameters, subjects with ATs exhibited increased values of P-wave duration in lead II, P-wave dispersion, PR interval in leads II, QRS duration in leads II and V₂, Tpeak-end interval in lead II, and Tpeak-end dispersion of the 12 leads in relation to those without ATs (P < 0.05). Among the assessed electrophysiological parameters, atrial-His (AH) and His-ventricular (HV) intervals were significantly prolonged in subjects with ATs (P < 0.05). Multiple Cox proportional hazards analysis revealed that P-wave duration in lead II, P-wave dispersion, Tpeak-end in lead II, Tpeak-end dispersion of the 12 leads, as well as AH and HV intervals are independent predictors of ATs in subjects with BS (P < 0.05). Cut-off point analysis showed that an HV interval ≥ 56 ms displayed the highest predictive ability (P < 0.01).
Conclusion: Our findings demonstrate that simple 12-lead ECG and electrophysiological parameters may easily be applied to identify high-risk subjects with BS ECG phenotype to develop ATs .