When and how to perform venoplasty for lead placement.

Due to increasing use of cardiac implantable electronic devices (CIEDs) with one or more intracardiac electrodes, the rate of lead failure is increasing. Moreover, an upgrade of the CIED is frequently indicated for cardiac resynchronization therapy or other reasons. Both these situations require a new intervention, preferably using the ipsilateral venous access. However, venous obstruction after CIED insertion occurs in 10-20% of patients and poses a major obstacle for implantation of additional leads. Possible solutions include lead extraction, contralateral lead insertion, and venoplasty. Preprocedural venoplasty is associated with the lowest short- and long-term risks. Here we describe a step-by-step approach to this technique, which can be introduced and safely performed in most interventional catheterization laboratories.

Medical Care as Flea Market Bargaining? An International Interdisciplinary Study of Varieties of Shared Decision Making in Physician-Patient Interactions.

Phenomenon: Shared decision making (SDM) is a core ideal in the interaction between healthcare providers and patients, but the implementation of the SDM ideal in clinical routines has been a relatively slow process. Approach: In a sociological study, 71 interactions between physicians and simulated patients enacting chronic heart failure were video-recorded in China, Germany, the Netherlands, and Turkey as part of a quasi-experimental research design. Participating physicians varied in specialty and level of experience. The secondary analysis presented in this article used content analysis to study core components of SDM in all of the 71 interactions and a grounded theory approach to observe how physicians responded actively to patients even though they did not actively employ the SDM ideal. Findings: Full realization of the SDM ideal remains an exception, but various aspects of SDM in physician-patient interaction were observed in all four locations. Analyses of longer interactions show dynamic processes of interaction that sometimes surprised both patient and physician. We observed varieties of SDM that differ from the SDM ideal but arguably achieve what the SDM ideal is intended to achieve. Our analysis suggests a need to revisit the SDM ideal-to consider whether varieties of SDM may be acceptable, even valuable, in their own right. Insights: The gap between the SDM ideal and SDM as implemented in clinical practice may in part be explained by the tendency of medicine to define and teach SDM through a narrow lens of checklist evaluations. The authors support the argument that SDM defies a checklist approach. SDM is not uniform, but nuanced, dependent on circumstances and setting. As SDM is co-produced by patients and physicians in a dynamic process of interaction, medical researchers should consider and medical learners should be exposed to varieties of SDM-related practice rather than a single idealized model. Observing and discussing worked examples contributes to the physician's development of realistic expectations and personal professional growth.

Impact of a Chronic Total Coronary Occlusion on the Incidence of Appropriate Implantable Cardioverter-Defibrillator Shocks and Mortality: A Substudy of the Dutch Outcome in ICD Therapy (DO-IT)) Registry.

BACKGROUND: Chronic total coronary occlusions (CTO) substantially increase the risk for sudden cardiac death. Among patients with chronic ischemic heart disease at risk for sudden cardiac death, an implantable cardioverter defibrillator (ICD) is the favored therapy for primary prevention of sudden cardiac death. This study sought to investigate the impact of CTOs on the risk for appropriate ICD shocks and mortality within a nationwide prospective cohort. METHODS AND RESULTS: This is a subanalysis of the nationwide Dutch-Outcome in ICD Therapy (DO-IT) registry of primary prevention ICD recipients in The Netherlands between September 2014 and June 2016 (n=1442). We identified patients with chronic ischemic heart disease (n=663) and assessed available coronary angiograms for CTO presence (n=415). Patients with revascularized CTOs were excluded (n=79). The primary end point was the composite of all-cause mortality and appropriate ICD shocks. Clinical follow-up was conducted for at least 2 years. A total of 336 patients were included, with an average age of 67±9 years, and 20.5% was female (n=69). An unrevascularized CTO was identified in 110 patients (32.7%). During a median follow-up period of 27 months (interquartile range, 24-32), the primary end point occurred in 21.1% of patients with CTO (n=23) compared with 11.9% in patients without CTO (n=27; P=0.034). Corrected for baseline characteristics including left ventricular ejection fraction, and the presence of a CTO was an independent predictor for the primary end point (hazard ratio, 1.82 [95% CI, 1.03-3.22]; P=0.038). CONCLUSIONS: Within this nationwide prospective registry of primary prevention ICD recipients, the presence of an unrevascularized CTO was an independent predictor for the composite outcome of all-cause mortality and appropriate ICD shocks.

Assessment of ICD eligibility in non-ischaemic cardiomyopathy patients: a position statement by the Task Force of the Dutch Society of Cardiology.

International guidelines recommend implantation of an implantable cardioverter-defibrillator (ICD) in non-ischaemic cardiomyopathy (NICM) patients with a left ventricular ejection fraction (LVEF) below 35% despite optimal medical therapy and a life expectancy of more than 1 year with good functional status. We propose refinement of these recommendations in patients with NICM, with careful consideration of additional risk parameters for both arrhythmic and non-arrhythmic death. These additional parameters include late gadolinium enhancement on cardiac magnetic resonance imaging and genetic testing for high-risk genetic variants to further assess arrhythmic risk, and age, comorbidities and sex for assessment of non-arrhythmic mortality risk. Moreover, several risk modifiers should be taken into account, such as concomitant arrhythmias that may affect LVEF (atrial fibrillation, premature ventricular beats) and resynchronisation therapy. Even though currently no valid cut-off values have been established, the proposed approach provides a more careful consideration of risks that may result in withholding ICD implantation in patients with low arrhythmic risk and substantial non-arrhythmic mortality risk.

Sex Differences in Outcomes of Patients with an Implantable Cardioverter-Defibrillator for the Secondary Prevention of Sudden Cardiac Death.

Background: In patients with an implantable cardioverter-defibrillator (ICD) for secondary prevention, sex differences may exist in clinical outcomes. We sought to investigate sex differences in appropriate ICD therapy, appropriate and inappropriate shock, and all-cause mortality in this patient population. Methods: A total of 257 patients who received an ICD for a secondary prevention indication in the University Medical Centre Groningen (UMCG) between 1 January 2012 and 31 December 2018 were retrospectively included in a consecutive manner. Appropriate ICD therapy, comprising shock and antitachycardia pacing (ATP) for ventricular fibrillation (VF) or ventricular tachycardia (VT), was the primary outcome. Results: The patient population included 257 patients, of whom 45 (18%) were women and 212 (82%) were men. The median of the age was 64 (interquartile range (IQR) 53-72) years. During follow-up (median duration 6.2 (IQR 4.8-7.8) years), first appropriate device therapy took place in 10 (22%) patients for women and 85 (40%) patients for men. Female sex was negatively associated with the rate of appropriate ICD therapy, univariably (hazard ratio (HR) 0.48 [95% confidence interval (CI) 0.25-0.93]; p = 0.030) and multivariably (HR 0.44 [95% CI 0.20-0.95]; p = 0.036). Conclusions: Women with secondary prevention ICDs were less likely than men to receive appropriate ICD therapy.

Predictive value of the PRAETORIAN score for defibrillation test success in patients with subcutaneous ICD: A subanalysis of the PRAETORIAN-DFT trial.

BACKGROUND: The PRAETORIAN score estimates the risk of failure of subcutaneous implantable cardioverter-defibrillator (S-ICD) therapy by using generator and lead positioning on bidirectional chest radiographs. The PRospective randomized compArative trial of subcutanEous implanTable cardiOverter-defibrillatoR ImplANtation with and without DeFibrillation Testing (PRAETORIAN-DFT) investigates whether PRAETORIAN score calculation is noninferior to defibrillation testing (DFT) with regard to first shock efficacy in spontaneous events. OBJECTIVE: This prespecified subanalysis assessed the predictive value of the PRAETORIAN score for defibrillation success in induced ventricular arrhythmias. METHODS: This multicenter investigator-initiated trial randomized 965 patients between DFT and PRAETORIAN score calculation after de novo S-ICD implantation. Successful DFT was defined as conversion of induced ventricular arrhythmia in <5 seconds from shock delivery within 2 attempts. Bidirectional chest radiographs were obtained after implantation. The predictive value of the PRAETORIAN score for DFT success was calculated for patients in the DFT arm. RESULTS: In total, 482 patients were randomized to undergo DFT. Of these patients, 457 (95%) underwent DFT according to protocol, of whom 445 (97%) had successful DFT and 12 (3%) had failed DFT. A PRAETORIAN score of ≥90 had a positive predictive value of 25% for failed DFT, and a PRAETORIAN score of <90 had a negative predictive value of 99% for successful DFT. A PRAETORIAN score of ≥90 was the strongest independent predictor for failed DFT (odds ratio 33.77; confidence interval 6.13-279.95; P < .001). CONCLUSION: A PRAETORIAN score of <90 serves as a reliable indicator for DFT success in patients with S-ICD, and a PRAETORIAN score of ≥90 is a strong predictor for DFT failure.

Smart devices to measure and monitor QT intervals.

Careful observation of the QT interval is important to monitor patients with long QT syndrome and during treatment with potentially QT-prolonging medication. It is also crucial in the development of novel drugs, in particular in case of a potential side effect of QT prolongation and in patients with increased risk of QT prolongation. The 12-lead electrocardiogram (ECG) is the gold standard to evaluate cardiac conduction and repolarization times. Smartwatches and smart devices offer possibilities for ambulatory ECG recording and therefore measuring and monitoring the QT interval. We performed a systematic review of studies on smartwatches and smart devices for QTc analysis. We reviewed PubMed for smartwatches and smart devices that can measure and monitor the QT interval. A total of 31 studies were included. The most frequent devices were (1) KardiaMobile 6L, a Food and Drug Administration-approved device for QTc analyses that provides a 6-lead ECG, (2) an Apple Watch, a smartwatch with an integrated ECG tool that allows recording of a single-lead ECG, and (3) the Withings Move ECG ScanWatch, an analog watch with a built-in single-lead ECG. The KardiaMobile 6L device and the Apple Watch provide accurate measurements of the QT interval, although the Apple Watch is studied in standard and non-standard positions, and the accuracy of QT measurements increased when the smartwatch was moved to alternative positions. Most studies were performed on patients, and limited results were available from healthy volunteers.

Association of vectorcardiographic T-wave area with clinical and echocardiographic outcomes in cardiac resynchronization therapy.

AIMS: Data on repolarization parameters in cardiac resynchronization therapy (CRT) are scarce. We investigated the association of baseline T-wave area, with both clinical and echocardiographic outcomes of CRT in a large, multi-centre cohort of CRT recipients. Also, we evaluated the association between the baseline T-wave area and QRS area. METHODS AND RESULTS: In this retrospective study, 1355 consecutive CRT recipients were evaluated. Pre-implantation T-wave and QRS area were calculated from vectorcardiograms. Echocardiographic response was defined as a reduction of ≥15% in left ventricular end-systolic volume between 3 and 12 months after implantation. The clinical outcome was a combination of all-cause mortality, heart transplantation, and left ventricular assist device implantation. Left ventricular end-systolic volume reduction was largest in patients with QRS area ≥ 109 µVs and T-wave area ≥ 66 µVs compared with QRS area ≥ 109 µVs and T-wave area < 66 µVs (P = 0.004), QRS area < 109 µVs and T-wave area ≥ 66 µVs (P < 0.001) and QRS area < 109 µVs and T-wave area < 66 µVs (P < 0.001). Event-free survival rate was higher in the subgroup of patients with QRS area ≥ 109 µVs and T-wave area ≥ 66 µVs (n = 616, P < 0.001) and QRS area ≥ 109 µVs and T-wave area < 66 µVs (n = 100, P < 0.001) than the other subgroups. In the multivariate analysis, T-wave area remained associated with echocardiographic response (P = 0.008), but not with the clinical outcome (P = 0.143), when QRS area was included in the model. CONCLUSION: Baseline T-wave area has a significant association with both clinical and echocardiographic outcomes after CRT. The association of T-wave area with echocardiographic response is independent from QRS area; the association with clinical outcome, however, is not.

Long-Term Performance of Epicardial versus Transvenous Left Ventricular Leads for Cardiac Resynchronization Therapy.

Aims: to study the technical performance of epicardial left ventricular (LV) leads placed via video assisted thoracic surgery (VATS), compared to transvenously placed leads for cardiac resynchronization therapy (CRT). Methods: From 2001 until 2013, a total of 644 lead placement procedures were performed for CRT. In the case of unsuccessful transvenous LV lead placement, the patient received an epicardial LV lead. Study groups consist of 578 patients with a transvenous LV lead and 66 with an epicardial LV lead. The primary endpoint was LV-lead failure necessitating a replacement or deactivation. The secondary endpoint was energy consumption. Results: The mean follow up was 5.9 years (epicardial: 5.5 ± 3.1, transvenous: 5.9 ± 3.5). Transvenous leads failed significantly more frequently than epicardial leads with a total of 66 (11%) in the transvenous leads group vs. 2 (3%) in the epicardial lead group (p = 0.037). Lead energy consumption was not significantly different between groups. Conclusions: Epicardial lead placement is feasible, safe and shows excellent long-term performance compared to transvenous leads. Epicardial lead placement should be considered when primary transvenous lead placement fails or as a primary lead placement strategy in challenging cases.

Appropriate Implantable Cardioverter-Defibrillator Therapy in Patients with Ventricular Arrhythmia of Unclear Cause in Secondary Prevention of Sudden Cardiac Death.

In this study, we sought to investigate the occurrence of appropriate implantable cardioverter-defibrillator (ICD) therapies and inappropriate shocks in secondary prevention ICD recipients with ventricular arrhythmia of unclear cause and ventricular arrhythmia in the context of underlying heart disease. In this retrospective study, consecutive patients with an ICD implanted for secondary prevention in the University Medical Center Groningen (UMCG), the Netherlands between 1 January 2012 and 31 December 2018 were included. Patients were classified as having ventricular arrhythmia of unclear cause if no clear cause was found which could explain the index ventricular arrhythmia. The primary outcome was appropriate ICD therapy. The study population consisted of 257 patients. In 220 patients, an underlying heart disease could be identified as the cause of ventricular arrhythmia, while 37 patients had an unclear cause of ventricular arrhythmia. The median age was 64 years (interquartile range (IQR) 53-72 years). Forty-five (18%) patients were women. During a median duration of follow-up of 6.2 years (IQR 4.8-7.8 years), appropriate ICD therapy occurred in 95 (37%) patients. This number was 90 (41%) in the group with a clear etiology and 5 (14%) in the group with an unclear etiology. In multivariable analysis, index ventricular arrhythmia of unclear cause was associated with fewer appropriate ICD therapies (HR 0.37 [95% CI 0.14-0.99]; p = 0.048), as well as an increased risk of inappropriate ICD shocks (HR 3.71 [95% CI 1.17-11.80]; p = 0.026). Index ventricular arrhythmia of unclear cause was significantly associated with fewer appropriate ICD therapies.

Prevalence and Incidence of Atrial Fibrillation in Heart Failure with Mildly Reduced or Preserved Ejection Fraction: (Additive) Value of Implantable Loop Recorders.

BACKGROUND: Atrial fibrillation (AF) is common in heart failure with mildly reduced or preserved ejection fraction (HFmrEF/HFpEF) and has a negative impact on outcome. Reliable data on prevalence, incidence, and detection of AF from contemporary, prospective HFmrEF/HFpEF studies are scarce. METHODS: This was a prespecified sub-analysis from a prospective, multicenter study. Patients with HFmrEF/HFpEF underwent 12-lead electrocardiography (ECG), 24 h Holter monitoring, and received an implantable loop recorder (ILR) at the study start. During the 2 year follow-up, rhythm monitoring was performed via ILR, yearly ECG, and two yearly 24 h Holter monitors. RESULTS: A total of 113 patients were included (mean age 73 ± 8 years, 75% HFpEF). At baseline, 70 patients (62%) had a diagnosis of AF: 21 paroxysmal, 18 persistent, and 31 permanent AF. At study start, 45 patients were in AF. Of the 43 patients without a history of AF, 19 developed incident AF during a median follow-up of 23 [15-25] months (44%; incidence rate 27.1 (95% confidence interval 16.3-42.4) per 100 person-years). Thus, after the 2-year follow-up, 89 patients (79%) had a diagnosis of AF. In 11/19 incident AF cases (i.e., 58%), AF was solely detected on the ILR. Yearly 12-lead ECG detected six incident AF cases and four of these cases were also detected on two yearly 24 h Holter monitors. Two incident AF cases were detected on an unplanned ECG/Holter. CONCLUSIONS: Atrial fibrillation is extremely common in heart failure with HFmrEF/HFpEF and may inform on symptom evaluation and treatment options. AF screening with an ILR had a much higher diagnostic yield than conventional modalities.

Five-year safety and efficacy of leadless pacemakers in a Dutch cohort.

BACKGROUND: Adequate real-world safety and efficacy of leadless pacemakers (LPs) have been demonstrated up to 3 years after implantation. Longer-term data are warranted to assess the net clinical benefit of leadless pacing. OBJECTIVE: The purpose of this study was to evaluate the long-term safety and efficacy of LP therapy in a real-world cohort. METHODS: In this retrospective cohort study, all consecutive patients with a first LP implantation from December 21, 2012, to December 13, 2016, in 6 Dutch high-volume centers were included. The primary safety endpoint was the rate of major procedure- or device-related complications (ie, requiring surgery) at 5-year follow-up. Analyses were performed with and without Nanostim battery advisory-related complications. The primary efficacy endpoint was the percentage of patients with a pacing capture threshold ≤2.0 V at implantation and without ≥1.5-V increase at the last follow-up visit. RESULTS: A total of 179 patients were included (mean age 79 ± 9 years), 93 (52%) with a Nanostim and 86 (48%) with a Micra VR LP. Mean follow-up duration was 44 ± 26 months. Forty-one major complications occurred, of which 7 were not advisory related. The 5-year major complication rate was 4% without advisory-related complications and 27% including advisory-related complications. No advisory-related major complications occurred a median 10 days (range 0-88 days) postimplantation. The pacing capture threshold was low in 163 of 167 patients (98%) and stable in 157 of 160 (98%). CONCLUSION: The long-term major complication rate without advisory-related complications was low with LPs. No complications occurred after the acute phase and no infections occurred, which may be a specific benefit of LPs. The performance was adequate with a stable pacing capture threshold.

Cardiac Resynchronization Therapy beyond Nominal Settings: An IEGM-Based Approach for Paced and Sensed Atrioventricular Delay Offset Optimization in Daily Clinical Practice.

Optimization of the atrioventricular (AV) delay has been performed in several landmark trials in cardiac resynchronization therapy (CRT), although it is often not performed in daily practice. Our aim was to study optimal AV delays and investigate a simple intracardiac electrogram (IEGM)-based optimization approach. 328 CRT patients with paired IEGM and echocardiography optimization data were included in our single-center observational study. Sensed (sAV) and paced (pAV) AV delays were optimized using an iterative echocardiography method. The offset between sAV and pAV delays was calculated using the IEGM method. The mean age of the patients was 69 ± 12 years; 64% were men, 48% had ischemic etiology of heart failure. During echocardiographic optimization, an offset of 73 ± 18 ms was found, differing from nominal AV settings (p < 0.001). Based on the IEGM method, the optimal offset was 75 ± 25 ms. The echocardiographic and IEGM-generated AV offset delays showed good correlation (R2 = 0.62, p < 0.001) and good agreement according to Bland-Altman plot analysis. CRT responders had a near zero offset difference between IEGM and echo optimization (-0.2 ± 17 ms), while non-responders had an offset difference of 6 ± 17 ms, p = 0.006. In conclusion, optimal AV delays are patient-specific and differ from nominal settings. pAV delay can easily be calculated from IEGM after sAV delay optimization.

Special Issue: Latest Advances in Delivery and Outcomes of Cardiac Resynchronization Therapy and Conduction System Pacing.

Cardiac Resynchronization Therapy (CRT) is an established technique to improve morbidity and mortality in selected heart failure patients [...].

NL-EVDR: Netherlands-ExtraVascular Device Registry.

Cardiac implantable electronic device (CIED) therapy is an essential element in treating cardiac arrhythmias. Despite their benefits, conventional transvenous CIEDs are associated with a significant risk of mainly pocket- and lead-related complications. To overcome these complications, extravascular devices (EVDs), such as the subcutaneous implantable cardioverter-defibrillator and intracardiac leadless pacemaker, have been developed. In the near future, several other innovative EVDs will become available. However, it is difficult to evaluate EVDs in large studies because of high costs, lack of long-term follow-up, imprecise data or selected patient populations. To improve evaluation of these technologies, real-world, large-scale, long-term data are of utmost importance. A Dutch registry-based study seems to be a unique possibility for this goal due to early involvement of Dutch hospitals in novel CIEDs and an existing quality control infrastructure, the Netherlands Heart Registration (NHR). Therefore, we will soon start the Netherlands-ExtraVascular Device Registry (NL-EVDR), a Dutch nationwide registry with long-term follow-up of EVDs. The NL-EVDR will be incorporated in NHR's device registry. Additional EVD-specific variables will be collected both retrospectively and prospectively. Hence, combining Dutch EVD data will provide highly relevant information on safety and efficacy. As a first step, a pilot project has started in selected centres in October 2022 to optimise data collection.