The development of a decision aid for shared decision making in the Dutch implantable cardioverter defibrillator patient population: A novel approach to patient education.

Background: Counseling of Implantable Cardioverter-defibrillator (ICD) patients with regard to individual risks and benefits is challenging. An evidence-based decision aid tailored to the needs of Dutch ICD patients is not yet available. The objective of this pilot project was to structurally evaluate the current clinical practice in The Netherlands and the ICD patient experience, in order to develop an online decision aid to facilitate shared decision making in ICD procedures. Methods: Between June 2016 and December 2017, a Dutch web-based decision aid was developed according to the Patient Decision Aid Standards (IPDAS) using the RAND-UCLA/multi-stepped Delphi model. Development process consisted of 5 stages in which the Dutch clinical practice was reviewed (stage 1), patients' needs and their history of decision making was structurally assessed (stages 2A and B) and a modified Delphi consensus process was performed with an expert panel consisting of representatives from different medical fields (stage 3). Results from stages 1-3 were used to design and structure the content of an online-based decision aid (stage 4) which was finally evaluated in a usability testing by patients in stage 5. Results and conclusion: This study describes the evidence-based approach to the development of the Dutch ICD decision aid. In our population, levels of shared decision-making experience were low. The ICD decision aid was structurally developed for the Dutch ICD patient population. Our upcoming multicenter stepped wedge clustered randomized trial will further evaluate the ICD decision aid in clinical practice.

Development and external validation of prediction models to predict implantable cardioverter-defibrillator efficacy in primary prevention of sudden cardiac death.

AIMS: This study was performed to develop and externally validate prediction models for appropriate implantable cardioverter-defibrillator (ICD) shock and mortality to identify subgroups with insufficient benefit from ICD implantation. METHODS AND RESULTS: We recruited patients scheduled for primary prevention ICD implantation and reduced left ventricular function. Bootstrapping-based Cox proportional hazards and Fine and Gray competing risk models with likely candidate predictors were developed for all-cause mortality and appropriate ICD shock, respectively. Between 2014 and 2018, we included 1441 consecutive patients in the development and 1450 patients in the validation cohort. During a median follow-up of 2.4 (IQR 2.1-2.8) years, 109 (7.6%) patients received appropriate ICD shock and 193 (13.4%) died in the development cohort. During a median follow-up of 2.7 (IQR 2.0-3.4) years, 105 (7.2%) received appropriate ICD shock and 223 (15.4%) died in the validation cohort. Selected predictors of appropriate ICD shock were gender, NSVT, ACE/ARB use, atrial fibrillation history, Aldosterone-antagonist use, Digoxin use, eGFR, (N)OAC use, and peripheral vascular disease. Selected predictors of all-cause mortality were age, diuretic use, sodium, NT-pro-BNP, and ACE/ARB use. C-statistic was 0.61 and 0.60 at respectively internal and external validation for appropriate ICD shock and 0.74 at both internal and external validation for mortality. CONCLUSION: Although this cohort study was specifically designed to develop prediction models, risk stratification still remains challenging and no large group with insufficient benefit of ICD implantation was found. However, the prediction models have some clinical utility as we present several scenarios where ICD implantation might be postponed.

The BRIGHT study: bifocal right ventricular resynchronization therapy: a randomized study.

AIMS: The BRIGHT study evaluated bifocal right ventricular (RV) (apex and outflow tract) pacing in a single, blind, randomized crossover study in patients eligible for cardiac resynchronization therapy (CRT). Forty-two patients were enrolled with the following characteristics: chronic drug refractory heart failure New York Heart Association (NYHA) class III-IV; ejection fraction (EF)<35%; QRS width >or= 120 ms; and a left bundle branch block. The aim of the study was to assess an improvement in left ventricular (LV) EF, 6 min walk test, Minnesota quality-of-life score, and NYHA classification. Methods and result Patients were randomized to receive either bifocal pacing or the control mode, each for a period of 3 months. Parameters were measured prior to randomization and after 3 months of control or bifocal pacing. Eight patients failed to make the 7 month follow-up, three patients died (one prior to randomization at the first month), five patients dropped out, and three patients refused further participation. One patient had a persistent lead problem, which was subsequently replaced with an LV lead, and one patient suffered with persistent atrial fibrillation. Compared with baseline, bifocal pacing improved EF from 26 +/- 12% to 36 +/- 11% (P < 0.0008), NYHA classification decreased from 2.8 +/- 0.4 to 2.3 +/- 0.7 (P < 0.007). Furthermore, the 6 min walk test improved from 372 +/- 129 m to 453 +/- 122 m (P < 0.05), and the Minnesota Living with Heart Failure scores decreased from 33 +/- 20 to 24 +/- 21 (P < 0.006). In the control group, no significant changes in any parameters were observed. Eight patients did not tolerate reprogramming from DDD BRIGHT to control pacing, with symptoms disappearing in all patients after reprogramming to bifocal pacing. CONCLUSION: Bifocal RV pacing in patients with a classic indication for CRT shows improvement in all parameters.

The contribution of rate adaptive pacing with single or dual sensors to health-related quality of life.

AIMS: The characteristics of sensors to perform rate adaptive pacing are well established but whether their contribution improves health-related quality of life (QoL) remains disputable. To compare the effects on QoL with an integrated dual sensor [minute ventilation (MV) and acceleration, TT sensor] with a single MV sensor, and with no rate adaptive pacing. METHODS AND RESULTS: This Dutch multi centre, prospective, single- (patient) blind study was performed in patients after first pacemaker (PM) implant for sick sinus syndrome or AV block. After a 3-month 'sensor off'-period following DDD PM implantation, where the latter 2 months permitted the MV sensor to learn the intrinsic rhythm, a 2-month period of DDDR with TT sensor or 2 months of DDDR with MV sensor, subsequently the two modes were crossed over. Quality of life was determined with Aquarel, the disease-specific instrument for PM patients. Heart rate, percentages of sensor driven and intrinsic rhythm were retrieved from PM memories. Sixty-four patients completed the 7-month study. In sick sinus patients, percentages of sensor-driven pacing occurred significantly more frequently than in AV block patients After implant QoL improved significantly: before 71.3 and after 83.5% (P < 0.001) measured with Aquarel and in 3 of 9 SF-36 scales, but no significant additive QoL benefit with dual or MV sensor pacing was observed. Pacing diagnosis, percentages of rate adaptive pacing, and heart rate influencing medication did not influence this result. CONCLUSION: Pacemaker implantation strongly improves QoL, but neither single- nor dual- sensor-driven pacing offered additional improvement in QoL during the initial 8 months after the first PM implant.

Chronic pseudoaneurysm of the left ventricle.

We present a case of a 55-year-old men who suffered a silent myocardial infarction four years earlier and presented with exertional dyspnoea. Cardiac magnetic resonance imaging (CMR) and Multislice computed tomography (MSCT) was performed and revealed a giant pseudoaneursym of the lateral wall of the left ventricle with the presence of a thrombus in the lateral wall of the pseudoaneursym. We present this case since excellent non-invasive evaluation of the pseudoaneursym was feasible using state-of-the-art imaging modalities. Information on left ventricular geometry and function as well as myocardial viability and coronary anatomy is available when both MSCT and CMR are performed. This combined approach of these two imaging modalities provide clinically relevant information and may guide therapeutic decision making.