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In transvenous implantable cardioverter-defibrillator (TV-ICD) implants, routine defibrillation testing (DFT) does not improve shock efficacy or reduce arrhythmic death but patients are exposed to the risk of complications related to DFT. The conversion rate of DFT in subcutaneous ICD (S-ICD) is high and first shock efficacy is similar to TV-ICD efficacy rates. The PRAETORIAN-DFT trial is an investigator-initiated, randomized, controlled, multicenter, prospective two-arm trial designed to demonstrate non-inferiority of omitting DFT in patients undergoing S-ICD implantation in which the S-ICD system components are optimally positioned. Positioning of the S-ICD will be assessed with the PRAETORIAN score. The PRAETORIAN score is developed to systematically evaluate implant position of the S-ICD system components which determine the defibrillation threshold on post-operative chest X-ray. A total of 965 patients, scheduled to undergo a de novo S-ICD implantation without contra-indications for either DFT strategy, will be randomized to either standard of care S-ICD implantation with DFT, or S-ICD implantation without DFT but with evaluation of the implant position using the PRAETORIAN score. The study is powered to claim non-inferiority of S-ICD implantation without DFT in de novo S-ICD patients in respect to the primary endpoint of first shock efficacy in spontaneous arrhythmia episodes. Patients with a high PRAETORIAN score (≥90) in the interventional arm of this study will undergo DFT according to the same DFT protocol as in the control arm. The PRAETORIAN-DFT trial is a randomized trial that aims to gain scientific evidence to safely omit a routine DFT after S-ICD implantation in patients with correct device positioning.

Background Untreated atrial fibrillation (AF) often results in increased morbidity and mortality. Opportunistic AF screening in persons aged ≥ 65 years is recommended to identify patients with AF in order to prevent AF-related complications. Objective The aim of this study was to assess the feasibility of screening persons for AF with the Kardia mobile electrocardiogram device (MED) and to determine the percentage of newly detected AF cases by selective population screening in the Netherlands. Methods Persons aged ≥ 65 years, without a medical history of AF, in nursing homes, at public events or visiting the general practitioner (GP) were approached to participate. A Kardia MED smartphone ECG (sECG) was recorded and the CHA 2 DS 2 -VASc score was calculated. An automated AF algorithm classified the sECGs as ‘sinus rhythm’, ‘AF’ or ‘unclassified’. In the case of AF, participants were referred to their GP. All sECGs were assessed by blinded experts. Results A total of 2168 participants were screened for AF. According to the expert’s interpretation, 2.5% had newly detected AF, of whom 76.4% never experienced palpitations and 89.1% had a CHA 2 DS 2 -VASc score ≥ 2. The algorithm result was unclassified in 12.2% of cases, of which 95.5% were interpretable by experts. With expert opinion as the gold standard and excluding unclassified sECGs, the Kardia MED’s negative and positive predictive value for detecting AF was 99.8% and 60.0%, respectively. Conclusion Screening for AF using the Kardia MED is feasible and results in 2.5% newly detected AF cases. Expert interpretation of algorithm outcomes AF and unclassified is recommended.

IntroductionAchieving optimal placement of the left ventricular (LV) lead in cardiac resynchronisation therapy (CRT) is a prerequisite in order to achieve maximum clinical benefit, and is likely to help avoid non-response. Pacing outside scar tissue and targeting late activated segments may improve outcome. The present study will be the first randomised controlled trial to compare the efficacy of real-time image-guided LV lead delivery to conventional CRT implantation. In addition, to estimate the cost-effectiveness of targeted lead implantation, an early decision analytic model was developed, and described here.Methods and analysisA multicentre, interventional, randomised, controlled trial will be conducted in a total of 130 patients with a class I or IIa indication for CRT implantation. Patients will be stratified to ischaemic heart failure aetiology and 1:1 randomised to either empirical lead placement or live image-guided lead placement. Ultimate lead location and echocardiographic assessment will be performed by core laboratories, blinded to treatment allocation and patient information. Late gadolinium enhancement cardiac magnetic resonance imaging (CMR) and CINE-CMR with feature-tracking postprocessing software will be used to semi-automatically determine myocardial scar and late mechanical activation. The subsequent treatment file with optimal LV-lead positions will be fused with the fluoroscopy, resulting in live target-visualisation during the procedure. The primary endpoint is the difference in percentage of successfully targeted LV-lead location. Secondary endpoints are relative percentage reduction in indexed LV end-systolic volume, a hierarchical clinical endpoint, and quality of life. The early analytic model was developed using a Markov-model, consisting of seven mutually exclusive health states.Ethics and disseminationThe protocol was approved by the Medical Research Ethics Committee Utrecht (NL73416.041.20). All participants are required to provide written informed consent. Results will be submitted to peer-reviewed journals.Trial registration numberNCT05053568; Trial NL8666.

BackgroundRenal nerve stimulation (RNS) is used to localize sympathetic nerve tissue for selective renal nerve sympathetic denervation (RDN). Examination of heart rate variability (HRV) provides a way to assess the state of the autonomic nervous system. The current study aimed to examine the acute changes in HRV caused by RNS before and after RDN.Methods and results30 patients with hypertension referred for RDN were included. RNS was performed under general anesthesia before and after RDN. Heart rate (HR) and blood pressure (BP) were continuously monitored. HRV characteristics were assessed 1 min before and after RNS and RDN. RNS before RDN elicited a maximum increase in systolic BP of 45 (± 22) mmHg which was attenuated to 13 (± 12) mmHg (p < 0.001) after RDN. RNS before RDN decreased the sinus cycle length from 1210 (± 201) ms to 1170 (± 203) ms (p = 0.03), after RDN this effect was blunted (p = 0.59). The LF/HF ratio in response to RNS changed from ∆ + 0.448 (± 0.550) before RDN to ∆ − 0.656 (± 0.252) after RDN (p = 0.02). Selecting patients off beta-blockade (n = 11), the RNS-induced changes in HRV components before versus after RDN were more pronounced (LF/HF ratio ∆ + 0.900 ± 1.171 versus ∆ − 0.828 ± 0.519, p = 0.01), whereas changes in HRV parameters in patients on beta-blockade (n = 19) were no longer significant. In patients with diabetes mellitus (n = 7), RNS induced no changes in HRV parameters (LF/HF ratio ∆ − 0.039 ± 0.103 versus ∆ − 0.460 ± 0.491, p = 0.92).ConclusionRNS induces changes in HRV suggesting increased sympathetic activity. Conversely, after RDN, the RNS-induced changes in HRV suggesting a lower sympathetic autonomic balance. These changes were most pronounced in beta-blocker naïve patients and not present in patients with diabetes mellitus. These findings could support RNS-guided RDN to optimize results.

AimsIn the SCALAF trial, catheter-based pulmonary vein isolation (PVI) was as effective in long-term prevention of atrial fibrillation (AF) as minimally invasive thoracoscopic PVI and left atrial appendage ligation (MIPI). Catheter ablation (CA) resulted in significantly less major complications as compare to MIPI. We report quality of life (QOL) outcome in these patients.MethodsIn this study, 52 patients with symptomatic paroxysmal or early persistent AF were randomized to either MIPI or CA. QOL was assessed at baseline, 3, 6, and 12 months follow-up using the SF-36 Health Survey Questionnaire. AF-related symptoms were quantified at each follow-up visit using the European Heart Rhythm Association (EHRA) score.ResultsMedian age was 57 years and 78% was male. Paroxysmal AF was present in 74%. At 3 months follow-up, physical role limitations (88.2 ± 29.5; versus 40.9 ± 44.0; P = 0.001, respectively) and bodily pain scores (95.5 ± 8.7; versus 76.0 ± 27.8; P = 0.021, respectively) were significantly higher after CA compared to MIPI, indicating less limitation in daily activity caused by physical problems and less pain after CA than after MIPI. AF symptoms assessed by the EHRA scores improved significantly at 3, 6, 12, and 24 months compared to baseline in both treatment groups (P < 0.001), with no significant differences between treatment groups.ConclusionsCA and MIPI ablation of AF both resulted in an improvement in several QOL measurements, although CA resulted in significantly less physical problems and bodily pain 3 months after treatment compared to MIPI.Clinical trial numberClinicalTrials.gov identifier: NCT00703157.Graphic abstract

Response to cardiac resynchronization therapy (CRT) is hampered by the extent and location of left ventricular (LV) scar tissue. It is commonly advised to avoid scar tissue while placing the LV lead. However, whether individual patients benefit from this strategy remains unclear. Thirty-two CRT candidates with ischemic cardiomyopathy were enrolled from 2 successive clinical trials (TBS and E-pot study). Magnetic resonance imaging with late contrast enhancement was performed to assess location, degree and transmurality of LV scar tissue. Patients underwent invasive pressure-volume loop measurements to assess acute LV pump function changes during pacing at posterolateral (PL) and anterolateral LV sites. In the study population (26 [81%] men, ejection fraction [EF] 22% ± 8%, QRS 149 ± 20 milliseconds), baseline mean stroke work (SW) and dP/dtmax were 4.4 ± 2.2 L∙mmHg and 849 ± 212 mmHg/s, respectively. The extent of scar tissue was inversely related to the acute increase in SW during pacing (R = −0.53, P = .002). Stimulating PL scar tissue resulted in deterioration of pump function (∆SW −17% ± 17%, P = .018), whereas pacing PL viable tissue led to an increase in pump function (∆SW +62% ± 51%, P < .001). Switching from pacing at the location of scar tissue, irrespective of the scar location, to viable tissue showed a significant increase in SW (−8% ± 20% vs +20 ± 40, P = .004). The extent of LV scar tissue is inversely related to acute pump function improvement during CRT. Pacing at the location of (transmural) scar tissue at any site of the LV will generally deteriorate LV pump function. Placing the LV lead over viable myocardium significantly improves pump function as compared with pacing at the location of scar tissue in patients with ischemic cardiomyopathy.

Purpose New X-ray technology providing new image processing techniques may reduce radiation exposure. The aim of this study was to quantify this radiation exposure reduction for patients during pacemaker and implantable cardioverter defibrillator (ICD) implantation. Methods In this retrospective study, 1185 consecutive patients who had undergone de novo pacemaker or ICD implantation during a 2-year period were included. All implantations in the first year were performed using the reference technology (Allura Xper), whereas in the second year, the new X-ray technology (AlluraClarity) was used. Radiation exposure, expressed as the dose area product (DAP), was compared between the two time periods to determine the radiation exposure reduction for pacemaker and ICD implantations without cardiac resynchronization therapy (CRT) and with CRT. Procedure duration and contrast volume were used as measures to compare complexity and image quality. Results The study population consisted of 591 patients who had undergone an implantation using the reference technology, and 594 patients with the new X-ray technology. The two groups did not differ in age, gender, or body mass index. The DAP decreased with 69 % from 16.4 ± 18.5 to 5.2 ± 6.6 Gy cm 2 for the non-CRT implantations ( p  < 0.001). The DAP decreased with 75 % from 72.1 ± 60.0 to 17.8 ± 17.4 Gy cm 2 for the CRT implantations ( p  < 0.001). Nevertheless, procedure duration and contrast volume did not differ when using the new technology ( p  = 0.09 and p  = 0.20, respectively). Conclusions Introduction of new X-ray technology resulted in a radiation exposure reduction of more than 69 % for patients during pacemaker and ICD implantation while image quality was unaffected.

Patients with an indication for an implantable cardioverter–defibrillator but no indication for pacing were randomly assigned to a subcutaneous or a transvenous ICD. At 49 months, the subcutaneous ICD was noninferior to the transvenous ICD with respect to device-related complications and inappropriate shocks.

Although prevalence of heart failure increases with age, in most clinical trials of cardiac resynchronization therapy (CRT), older patients are not included. Observational studies of effects of CRT in older patients had a small sample size. In the present study, the clinical and echocardiographic response to CRT in a larger group of elderly (age >75 years) patients was evaluated. In this prospective observational study of 266 consecutive patients, CRT was performed in 107 elderly patients (40%) and 159 (60%) younger patients (age ≤75 years). Echocardiographic and clinical parameters were evaluated at baseline and at 3, 12, and 24 months. In the elderly group, mean age was 79 years compared with 67 years in patients aged ≤75 years. Clinical baseline characteristics between the 2 groups were comparable. During follow-up, there was a comparable and sustained improvement in both groups according to New York Heart Association (NYHA) class, quality of life score, and left ventricular (LV) ejection fraction. Clinical response, defined as survival with improvement (≥1 score) of NYHA class without hospital admittance for heart failure, was seen in 67% and 69% (group aged ≤75 years) versus 65% and 60% (group aged >75 years) after 3 months and 1 year, respectively. Reverse LV remodeling defined as LV end-systolic volume reduction ≥10% was seen in 79% and 87% (group aged ≤75 years) versus 71% and 79% (group aged >75 years) after 3 months and 1 year, respectively. Hospitalization for heart failure decreased significantly in both groups in the year after CRT. A subgroup analysis of 39 octogenarians (>80 years) also showed a significant improvement in NYHA class and LV ejection fraction in this subgroup. Also, LV reverse remodeling occurred in a similar extent (75% and 84%) after 3 months and 1 year, respectively. This study shows a clinical and echocardiographic improvement of CRT in patients aged >75 years and even so in octogenarians.