Methodological limitations of psychosocial interventions in patients with an implantable cardioverter-defibrillator (ICD) A systematic review

<p>Abstract</p> <p>Background</p> <p>Despite the potentially life-saving benefits of the implantable cardioverter-defibrillator (ICD), a significant group of patients experiences emotional distress after ICD implantation. Different psychosocial interventions have been employed to improve this condition, but previous reviews have suggested that methodological issues may limit the validity of such interventions. Aim: To review the methodology of previously published studies of psychosocial interventions in ICD patients, according to CONSORT statement guidelines for non-pharmacological interventions, and provide recommendations for future research.</p> <p>Methods</p> <p>We electronically searched the PubMed, PsycInfo and Cochrane databases. To be included, studies needed to be published in a peer-reviewed journal between 1980 and 2008, to involve a human population aged 18+ years and to have an experimental design.</p> <p>Results</p> <p>Twelve studies met the eligibility criteria. Samples were generally small. Interventions were very heterogeneous; most studies used cognitive behavioural therapy (CBT) and exercise programs either as unique interventions or as part of a multi-component program. Overall, studies showed a favourable effect on anxiety (6/9) and depression (4/8). CBT appeared to be the most effective intervention. There was no effect on the number of shocks and arrhythmic events, probably because studies were not powered to detect such an effect. Physical functioning improved in the three studies evaluating this outcome. Lack of information about the indication for ICD implantation (primary vs. secondary prevention), limited or no information regarding use of anti-arrhythmic (9/12) and psychotropic (10/12) treatment, lack of assessments of providers' treatment fidelity (12/12) and patients' adherence to the intervention (11/12) were the most common methodological limitations.</p> <p>Conclusions</p> <p>Overall, this review supports preliminary evidence of a positive effect of psychosocial interventions on anxiety and physical functioning in ICD patients. However, these initial findings must be interpreted cautiously because of important methodological limitations. Future studies should be designed as large RCTs, whose design takes into account the specific challenges associated with the evaluation of behavioural interventions.</p

Examination of a middle cardiac vein defibrillation coil as stand-alone anode, auxiliary anode, and bystander electrode in a transvenous defibrillation circuit

In porcine studies anodes in the middle cardiac vein compare favorably with those in the RV. It has not been demonstrated whether the RV and middle cardiac vein or the middle cardiac vein alone anodes are superior when shocking to a conventional SVC and active housing cathode nor whether a bystander middle cardiac vein electrode exerts a passive electrode affect. Twelve pigs were anesthetized and had an active housing implanted in the left pectoral region and defibrillation coils placed at the RV apex and in the SVC. A custom-made defibrillation coil (Ela Medical) was advanced into the middle cardiac vein through a 9 Fr transvenous catheter. The DFT for three anodes (RV; RV and middle cardiac vein; middle cardiac vein) to the SVC and active housing was then assessed by a three reversal binary search, the order of testing was randomized. In seven animals DFT was assessed in the same way for the configuration of RV to SVC and active housing twice more, with and without a bystander middle cardiac vein coil electrode in place. The results were middle cardiac vein 7.5 ± 1.7 J, RV and middle cardiac vein 7.3 ± 1.7 J reduced DFT significantly compared to RV 13.8 ± 4.2 J (both P &lt; 0.000). There was no significant difference between the middle cardiac vein and the middle cardiac vein and RV (P = 0.67, 95% CI for difference ? 0.64–0.96). The DFT of RV to SVC and the active housing was the same with (13.2 ± 4.0) and without (13.7 ± 4.2) the middle cardiac vein bystander coil in place (P = 0.177, 95% CI for difference ? 0.33–1.33 J). Shocking to a SVC and active housing cathode, middle cardiac vein, and RV and middle cardiac vein anodes are equally effective in lowering DFT compared to the RV. The middle cardiac vein coil electrode does not exert a passive electrode affect on the RV to the SVC and active housing defibrillation