Quality and transparency of evidence for implantable cardiovascular medical devices assessed by the CORE-MD consortium.

BACKGROUND AND AIMS: The European Union Medical Device Regulation 2017/745 challenges key stakeholders to follow transparent and rigorous approaches to the clinical evaluation of medical devices. The purpose of this study is a systematic evaluation of published clinical evidence underlying selected high-risk cardiovascular medical devices before and after market access in the European Union (CE-marking) between 2000 and 2021. METHODS: Pre-specified strategies were applied to identify published studies of prospective design evaluating 71 high-risk cardiovascular devices in seven different classes (bioresorbable coronary scaffolds, left atrial appendage occlusion devices, transcatheter aortic valve implantation systems, transcatheter mitral valve repair/replacement systems, surgical aortic and mitral heart valves, leadless pacemakers, subcutaneous implantable cardioverter-defibrillator). The search time span covered 20 years (2000-21). Details of study design, patient population, intervention(s), and primary outcome(s) were summarized and assessed with respect to timing of the corresponding CE-mark approval. RESULTS: At least one prospective clinical trial was identified for 70% (50/71) of the pre-specified devices. Overall, 473 reports of 308 prospectively designed studies (enrolling 97 886 individuals) were deemed eligible, including 81% (251/308) prospective non-randomized clinical trials (66 186 individuals) and 19% (57/308) randomized clinical trials (31 700 individuals). Pre-registration of the study protocol was available in 49% (150/308) studies, and 16% (48/308) had a peer-reviewed publicly available protocol. Device-related adverse events were evaluated in 82% (253/308) of studies. An outcome adjudication process was reported in 39% (120/308) of the studies. Sample size was larger for randomized in comparison to non-randomized trials (median of 304 vs. 100 individuals, P < .001). No randomized clinical trial published before CE-mark approval for any of the devices was identified. Non-randomized clinical trials were predominantly published after the corresponding CE-mark approval of the device under evaluation (89%, 224/251). Sample sizes were smaller for studies published before (median of 31 individuals) than after (median of 135 individuals) CE-mark approval (P < .001). Clinical trials with larger sample sizes (>50 individuals) and those with longer recruitment periods were more likely to be published after CE-mark approval, and were more frequent during the period 2016-21. CONCLUSIONS: The quantity and quality of publicly available data from prospective clinical investigations across selected categories of cardiovascular devices, before and after CE approval during the period 2000-21, were deemed insufficient. The majority of studies was non-randomized, with increased risk of bias, and performed in small populations without provision of power calculations, and none of the reviewed devices had randomized trial results published prior to CE-mark certification.

Epicardial adipose tissue dispersion at CT and recurrent atrial fibrillation after pulmonary vein isolation.

OBJECTIVES: Epicardial adipose tissue (EAT) remodeling is associated with atrial fibrillation (AF). Left atrial (LA) EAT dispersion on cardiac CT is a non-invasive imaging biomarker reflecting EAT heterogeneity. We aimed to investigate the association of LA EAT dispersion with AF recurrence after pulmonary vein isolation (PVI). METHODS: In a prospective registry of consecutive patients undergoing first PVI, mean EAT attenuation values were measured on contrast-enhanced cardiac CT scans in Hounsfield units (HU) within low (- 195 to - 45 HU) and high (- 44 to - 15 HU) threshold EAT compartments around the left atrium (LA). EAT dispersion was defined as the difference between the mean HU values within the two EAT compartments. Continuous variables were compared between groups using the Mann-Whitney U test and cox proportional hazard models were used to calculate hazard ratios of predictors of 1-year AF recurrence. RESULTS: A total of 208 patients were included, 135 with paroxysmal AF and 73 with persistent AF. LA EAT dispersion was significantly larger in patients with persistent compared to paroxysmal AF (52.6 HU vs. 49.9 HU; p = 0.001). After 1 year of follow-up, LA EAT dispersion above the mean (> 50.8 HU) was associated with a higher risk of AF recurrence (HR 2.3, 95% CI 1.5-3.6; p < 0.001). It retained its predictive value when corrected for age, sex, body mass index, LA volume, and AF type (HR 2.8, 95% CI 1.6-4.6; p < 0.001). CONCLUSION: A larger LA EAT dispersion on contrast-enhanced cardiac CT scans, reflecting EAT heterogeneity, is independently associated with AF recurrence after PVI. CLINICAL RELEVANCE STATEMENT: Based on LA EAT dispersion assessment, a more accurate risk stratification and patient selection may be possible based on a pre-procedural cardiac CT when planning PVI. KEY POINTS: • Epicardial adipose tissue (EAT) remodeling is associated with atrial fibrillation (AF). • A larger left atrial EAT dispersion in a pre-procedural cardiac CT was associated with a higher 1-year AF recurrence risk after pulmonary vein isolation. • A pre-procedural cardiac CT with left atrial EAT dispersion assessment may provide a more accurate risk stratification and patient selection for PVI.

Impact of atrial fibrillation phenotype and left atrial volume on outcome after pulmonary vein isolation.

AIMS: Pulmonary vein isolation (PVI) is increasingly performed in patients with atrial fibrillation (AF). Both AF phenotype and left atrial (LA) volume have been shown to influence ablation outcome. The inter-relationship of the two is incompletely understood. We aimed to investigate the impact of AF phenotype vs. LA volume on outcome after PVI. METHODS AND RESULTS: In a retrospective analysis of a prospective registry of patients undergoing a first PVI, the association of AF phenotype and LA volume index (LAVI) was assessed as well as their impact on AF recurrence during follow-up. Overall, 476 patients were enrolled (median age 63 years, 29% females, 65.8% paroxysmal AF). Obesity, hypertension, chronic kidney disease, and heart failure were all significantly more frequent in persistent AF. After 1 year, single-procedure, freedom from arrhythmia recurrence was 61.5%. Patients with paroxysmal AF had better outcomes compared with patients with persistent AF (65.6 vs. 52.7%, P = 0.003), as had patients with no/mild vs. moderate/severe LA dilation (LAVI <42 mL/m2 67.1% vs. LAVI ≥42 mL/m2 53%, P < 0.001). The combination of both parameters refined prediction of 1-year recurrence (P < 0.001). After adjustment for additional clinical risk factors in multivariable Cox proportional hazard analysis, both AF phenotype and LAVI ≥42 mL/m2 contributed significantly towards the prediction of 1-year recurrence. CONCLUSION: Atrial fibrillation phenotype and LA volume are independent predictors of outcome after PVI. Persistent AF with no/mild LA dilation has a similar risk of recurrence as paroxysmal AF with a moderate/severe LA dilation and should be given similar priority for ablation.

Patient characteristics, predictors and outcome of pacemaker patients upgraded to an implantable cardioverter defibrillator.

AIMS: Pacemaker (PM) patients may require a subsequent upgrade to an implantable cardioverter defibrillator (ICD). Limited data exists on this patient population. We sought to characterize this population, to assess predictors for ICD upgrade, and to report the outcome. METHODS: From our prospective PM and ICD implantation registry, all patients who underwent PM and/or ICD implantations at our center were analyzed. Patient characteristics and outcomes of PM patients with subsequent ICD upgrade were compared to age- and sex-matched patients with de novo ICD implantation, and to PM patients without subsequent upgrade. RESULTS: Of 1'301 ICD implantations, 60 (5%) were upgraded from PMs. Median time from PM implantation to ICD upgrade was 2.6 years (IQR 1.3-5.4). Of 2'195 PM patients, 28 patients underwent subsequent ICD upgrades, corresponding to an estimated annual incidence of an ICD upgrade of at least 0.33%. Lower LVEF (p = .05) and male sex (p = .038) were independent predictors for ICD upgrade. Survival without death, transplant and LVAD implantation were worse both for upgraded ICD patients compared to matched patients with de novo ICD implantation (p = .05), as well as for PM patients with subsequent upgrade compared to matched PM patients not requiring an upgrade (p = .036). CONCLUSIONS: One of 20 ICD implantations are upgrade of patients with a PM. At least one of 30 PM patients will require an ICD upgrade in the following 10 years. Predictors for ICD upgrade are male sex and lower LVEF at PM implantation. Upgraded patients have worse outcomes.

Validation of the accuracy of contact force measurement by contemporary force-sensing ablation catheters.

INTRODUCTION: Contact force sensing catheters are widely used for ablation of cardiac arrhythmias. They allow quantification of catheter-to-tissue contact, which is an important determinant for lesion formation and may reduce the risk of complications. The accuracy of these sensors may vary across the measurement range, catheter-to-tissue angle, and amongst manufacturers. We aim to compare the accuracy and reproducibility of four different force sensing ablation catheters. METHODS: A measurement setup containing a heated saline water bath with an integrated force measurement unit was constructed and validated. Subsequently, we investigated four different catheter models, each equipped with a unique measurement technology: Tacticath Quartz (Abbott), AcQBlate Force (Biotronik/Acutus), Stablepoint (Boston Scientific), and Smarttouch SF (Biosense Webster). For each model, the accuracy of three different catheters was measured within the range of 0-60 g and at contact angles of 0°, 30°, 45°, 60°, and 90°. RESULTS: In total, 6685 measurements were performed using 4 × 3 catheters (median of 568, interquartile range: 511-606 measurements per catheter). Over the entire measurement-range, the force measured by the catheters deviated from the real force by the following absolute mean values: Tacticath 1.29 ± 0.99 g, AcQBlate Force 2.87 ± 2.37 g, Stablepoint 1.38 ± 1.29 g, and Smarttouch 2.26 ± 2.70 g. For some models, significant under- and overestimation of >10 g were observed at higher forces. Mean absolute errors of all models across the range of 10-40 g were <3 g. CONCLUSION: Contact measured by force-sensing catheters is accurate with 1-3 g deviation within the range of 10-40 g. Significant errors can occur at higher forces with potential clinical consequences.

Sense-B-noise: an enigmatic cause for inappropriate shocks in subcutaneous implantable cardioverter defibrillators.

AIMS: Subcutaneous implantable cardioverter defibrillators (S-ICDs) are well established. However, inappropriate shocks (IAS) remain a source of concern since S-ICDs offer very limited troubleshooting options. In our multicentre case series, we describe several patients who experienced IAS due to a previously unknown S-ICD system issue. METHODS AND RESULTS: We observed six patients suffering from this novel IAS entity. The IAS occurred exclusively in primary or alternate S-ICD sensing vector configuration (therefore called 'Sense-B-noise'). IAS were caused by non-physiologic oversensing episodes characterized by intermittent signal saturation, diminished QRS amplitudes, and disappearance of the artefacts after the IAS. Noise/oversensing could not be provoked by manipulation, X-ray did not show evidence for lead/header issues and impedance measurements were within normal limits. The pooled experience of our centres implies that up to ∼5% of S-ICDs may be affected. The underlying root cause was discussed extensively with the manufacturer but remains unknown and is under further investigation. CONCLUSION: Sense-B-noise is a novel cause for IAS due to non-physiologic signal oversensing, arising from a previously unknown S-ICD system issue. Sense-B-noise may be suspected if episodes of signal saturation in primary or alternate vector configuration are present, oversensing cannot be provoked, and X-ray and electrical measurements appear normal. The issue can be resolved by reprogramming the device to secondary sensing vector.

Posterior wall ablation by pulsed-field ablation: procedural safety, efficacy, and findings on redo procedures.

AIMS: The left atrial posterior wall is a potential ablation target in patients with recurrent atrial fibrillation despite durable pulmonary vein isolation or in patients with roof-dependent atrial tachycardia (AT). Pulsed-field ablation (PFA) offers efficient and safe posterior wall ablation (PWA), but available data are scarce. METHODS AND RESULTS: Consecutive patients undergoing PWA using PFA were included. Posterior wall ablation was performed using a pentaspline PFA catheter and verified by 3D-electroanatomical mapping. Follow-up was performed using 7-day Holter ECGs 3, 6, and 12 months after ablation. Recurrence of any atrial arrhythmia lasting more than 30 s was defined as failure. Lesion durability was assessed during redo procedures. Posterior wall ablation was performed in 215 patients (70% males, median age 70 [IQR 61-75] years, 67% redo procedures) and was successful in all patients (100%) by applying a median of 36 (IQR 32-44) PFA lesions. Severe adverse events were cardiac tamponade and vascular access complication in one patient each (0.9%). Median follow-up was 7.3 (IQR 5.0-11.8) months. One-year arrhythmia-free outcome in Kaplan-Meier analysis was 53%. A redo procedure was performed in 26 patients (12%) after a median of 6.9 (IQR 2.4-11) months and showed durable PWA in 22 patients (85%) with only minor lesion regression. Among four patients with posterior wall reconnection, three (75%) presented with roof-dependent AT. CONCLUSION: Posterior wall ablation with this pentaspline PFA catheter can be safely and efficiently performed with a high durability observed during redo procedures. The added value of durable PWA for the treatment of atrial fibrillation remains to be evaluated.

Validation of a clinical model for predicting left versus right ventricular outflow tract origin of idiopathic ventricular arrhythmias.

BACKGROUND: Prediction of the chamber of origin in patients with outflow tract ventricular arrhythmias (OTVA) remains challenging. A clinical risk score based on age, sex and presence of hypertension was associated with a left ventricular outflow tract (LVOT) origin. We aimed to validate this clinical score to predict an LVOT origin in patients with OTVA. METHODS: In a two-center observational cohort study, unselected patients undergoing catheter ablation (CA) for OTVA were enrolled. All procedures were performed using an electroanatomical mapping system. Successful ablation was defined as a ≥80% reduction of the initial overall PVC burden after 3 months of follow-up. Patients with unsuccessful ablation were excluded from this analysis. RESULTS: We included 187 consecutive patients with successful CA of idiopathic OTVA. Mean age was 52 ± 15 years, 102 patients (55%) were female, and 74 (40%) suffered from hypertension. A LVOT origin was found in 64 patients (34%). A score incorporating age, sex and presence of hypertension reached 73% sensitivity and 67% specificity for a low (0-1) and high (2-3) score, to predict an LVOT origin. The combination of one ECG algorithm (V2 S/V3 R-index) with the clinical score resulted in a sensitivity and specificity of 81% and 70% for PVCs with R/S transition at V3 . CONCLUSION: The published clinical score yielded a lower sensitivity and specificity in our cohort. However, for PVCs with R/S transition at V3, the combination with an existing ECG algorithm can improve the predictability of LVOT origin.

Acute and long-term outcomes of quadripolar IS-4 versus bipolar IS-1 left ventricular leads in cardiac resynchronization therapy: A retrospective registry study.

BACKGROUND: The implantation procedure of left ventricular (LV) leads and the management of cardiac resynchronization therapy (CRT) patients can be challenging. The IS-4 standard for CRT offers additional pacing vectors compared to bipolar leads (IS-1). IS-4 leads improve procedural outcome and may also result in lower adverse events during follow-up (FU) and improve clinical outcome in CRT patients. Further long-term FU data comparing the two lead designs are necessary. METHODS: In this retrospective, single-center study we included adult patients implanted with a CRT-Defibrillator (CRT-D) or CRT-Pacemaker (CRT-P) with a quadripolar (IS-4 group) or bipolar (IS-1 group) LV lead and with available ≥3 years clinical FU. The combined primary endpoint was a combination of predefined, lead-related adverse events. Secondary endpoints were all single components of the primary endpoint. RESULTS: Overall, 133 patients (IS-4 n = 66; IS-1 n = 67) with a mean FU of 4.03 ± 1.93 years were included. Lead-related adverse events were less frequent in patients with an IS-4 lead than with an IS-1 lead (n = 8, 12.1% vs. n = 23, 34.3%; p = .002). The secondary outcomes showed a lower rate of LV lead deactivation/explantation and LV lead dislodgement/dysfunction (4.5% vs. 22.4%; p = .003; 4.5% vs. 17.9%; p = .015, respectively) in the IS-4 patient group. Less patients suffered from unresolved phrenic nerve stimulation with an IS-4 lead (3.0% vs. 13.4%; p = .029). LV lead-related re-interventions were fewer in case of an IS-4 lead (6.1% vs. 17.9%; p = .036). CONCLUSION: In this retrospective analysis, the IS-4 LV lead is associated with lower lead-related complication rates than the IS-1 lead at long-term FU.

Feasibility of transesophageal phrenic nerve stimulation.

BACKGROUND: Every year, more than 2.5 million critically ill patients in the ICU are dependent on mechanical ventilation. The positive pressure in the lungs generated by the ventilator keeps the diaphragm passive, which can lead to a loss of myofibers within a short time. To prevent ventilator-induced diaphragmatic dysfunction (VIDD), phrenic nerve stimulation may be used. OBJECTIVE: The goal of this study is to show the feasibility of transesophageal phrenic nerve stimulation (TEPNS). We hypothesize that selective phrenic nerve stimulation can efficiently activate the diaphragm with reduced co-stimulations. METHODS: An in vitro study in saline solution combined with anatomical findings was performed to investigate relevant stimulation parameters such as inter-electrode spacing, range to target site, or omnidirectional vs. sectioned electrodes. Subsequently, dedicated esophageal electrodes were inserted into a pig and single stimulation pulses were delivered simultaneously with mechanical ventilation. Various stimulation sites and response parameters such as transdiaphragmatic pressure or airway flow were analyzed to establish an appropriate stimulation setting. RESULTS: Phrenic nerve stimulation with esophageal electrodes has been demonstrated. With a current amplitude of 40 mA, similar response figures of the diaphragm activation as compared to conventional stimulation with needle electrodes at 10mA were observed. Directed electrodes best aligned with the phrenic nerve resulted in up to 16.9 % higher amplitude at the target site in vitro and up to 6 cmH20 higher transdiaphragmatic pressure in vivo as compared to omnidirectional electrodes. The activation efficiency was more sensitive to the stimulation level inside the esophagus than to the inter-electrode spacing. Most effective and selective stimulation was achieved at the level of rib 1 using sectioned electrodes 40 mm apart. CONCLUSION: Directed transesophageal phrenic nerve stimulation with single stimuli enabled diaphragm activation. In the future, this method might keep the diaphragm active during, and even support, artificial ventilation. Meanwhile, dedicated sectioned electrodes could be integrated into gastric feeding tubes.

The Relationship between Enhancing Left Atrial Adipose Tissue at CT and Recurrent Atrial Fibrillation.

Background The association of epicardial adipose tissue (EAT) and its metabolic activity with atrial fibrillation (AF) is an area of active investigation. Left atrial (LA) enhancing EAT (e-EAT) at cardiac CT may be a noninvasive surrogate marker for the metabolic activity of EAT. Purpose To determine the relationship between LA e-EAT and recurrence after AF ablation. Materials and Methods In a secondary analysis of a prospective registry of consecutive patients (from July 2018 to December 2019) undergoing first AF ablation, total and LA EAT were segmented on preprocedural noncontrast- and contrast-enhanced cardiac CT scans. LA e-EAT volume fraction was defined as the LA EAT volume difference between the noncontrast- and contrast-enhanced scan divided by the total LA EAT volume on the noncontrast-enhanced scan (threshold values, -15 HU to -195 HU). Continuous variables were compared between groups by using the Mann-Whitney U test. Cox proportional hazard models were used to calculate hazard ratios of predictors of 1-year AF recurrence. Results A total of 212 patients (mean age, 64 years; 159 men) who underwent a first AF ablation were included (paroxysmal AF, 64%; persistent AF, 36%). The LA EAT volume was higher in patients with persistent versus paroxysmal AF (50 cm3 [IQR, 37-72] vs 37 [IQR, 27-49]; P < .001), but no difference was found for LA e-EAT (P = .09). After 1 year of follow-up, AF recurrence rate was 77 of 212 (36%). LA e-EAT above the mean (>33%) was associated with a higher risk of AF recurrence (hazard ratio [HR], 2.1; 95% CI: 1.3, 3.3; P < .01). In a multivariable Cox regression analysis, LA e-EAT retained its predictive value when corrected for sex, age, AF phenotype, LA volume index, and LA EAT volume (HR, 1.9; 95% CI: 1.1, 3.1; P = .02). Conclusion Left atrial enhancing epicardial adipose tissue was independently associated with recurrence after atrial fibrillation ablation. © RSNA, 2022 Online supplemental material is available for this article. See also the editorial by Stojanovska in this issue.

Evolution of tricuspid valve regurgitation after implantation of a leadless pacemaker: A single center experience, systematic review, and meta-analysis.

INTRODUCTION: Conventional transvenous pacemaker leads may interfere with the tricuspid valve leaflets, tendinous chords, and papillary muscles, resulting in significant tricuspid valve regurgitation (TR). Leadless pacemakers (LLPMs) theoretically cause less mechanical interference with the tricuspid valve apparatus. However, data on TR after LLPM implantation are sparse and conflicting. Our goal was to investigate the prevalence of significant TR before and after LLPM implantation. METHODS: Patients who received a leadless LLPM (Micra™ TPS, Medtronic) between May 2016 and May 2021 at our center were included in this observational study if they had at least a pre- and postinterventional echocardiogram (TTE). The evolution of TR severity was assessed. Following a systematic literature review on TR evolution after implantation of a LLPM, data were pooled in a random-effects meta-analysis. RESULTS: We included 69 patients (median age 78 years [interquartile range (IQR) 72-84 years], 26% women). Follow-up duration between baseline and follow-up TTE was 11.4 months (IQR 3.5-20.1 months). At follow-up, overall TR severity was not different compared to baseline (p = .49). Six patients (9%) had new significant TR during follow-up after LLPM implantation, whereas TR severity improved in seven patients (10%). In the systematic review, we identified seven additional articles that investigated the prevalence of significant TR after LLPM implantation. The meta-analysis based on 297 patients failed to show a difference in significant TR before and after LLPM implantation (risk ratio 1.22, 95% confidence interval 0.97-1.53, p = .11). CONCLUSION: To date, there is no substantial evidence for a significant change in TR after implantation of a LLPM.

Multichannel esophageal signals to monitor respiratory rate in preterm infants.

BACKGROUND: Apnea of prematurity cannot be reliably measured with current monitoring techniques. Instead, indirect parameters such as oxygen desaturation or bradycardia are captured. We propose a Kalman filter-based detection of respiration activity and hence apnea using multichannel esophageal signals in neonatal intensive care unit patients. METHODS: We performed a single-center observational study with moderately preterm infants. Commercially available nasogastric feeding tubes containing multiple electrodes were used to capture signals with customized software. Multichannel esophageal raw signals were manually annotated, processed using extended Kalman filter, and compared with standard monitoring data including chest impedance to measure respiration activity. RESULTS: Out of a total of 405.4 h captured signals in 13 infants, 100 episodes of drop in oxygen saturation or heart rate were examined. Median (interquartile range) difference in respiratory rate was 0.04 (-2.45 to 1.48)/min between esophageal measurements annotated manually and with Kalman filter and -3.51 (-7.05 to -1.33)/min when compared to standard monitoring, suggesting an underestimation of respiratory rate when using the latter. CONCLUSIONS: Kalman filter-based estimation of respiratory activity using multichannel esophageal signals is safe and feasible and results in respiratory rate closer to visual annotation than that derived from chest impedance of standard monitoring.

Validation of a multipolar pulsed-field ablation catheter for endpoint assessment in pulmonary vein isolation procedures.

AIMS: To validate the performance of a multipolar pulsed-field ablation (PFA) catheter compared to a standard pentaspline 3D-mapping catheter for endpoint assessment of pulmonary vein isolation (PVI). PFA for PVI using single-shot devices combines the benefits of high procedural efficacy and safety. A newly available multipolar PFA catheter allows real-time recording of pulmonary vein (PV) signals during PVI. METHODS AND RESULTS: Patients undergoing first PVI using PFA with the standard ablation protocol (eight applications per PV) were studied. Entrance and exit block (10 V/2 ms) were assessed using the PFA catheter. Subsequently, a high-density 3D electroanatomical bipolar voltage map (3D-EAM) was constructed using a standard pentaspline 3D-mapping catheter. Additional PFA applications were delivered only after confirmation of residual PV connection by 3D-EAM. In 56 patients, 213 PVs were targeted for ablation. Acute PVI was achieved in 100% of PVs: in 199/213 (93%) PVs with the standard ablation protocol alone and in the remaining 14 PVs after additional PFA applications. The accuracy of PV assessment with the PFA catheter after the standard ablation protocol was 91% (194/213 veins). In 5/213 (2.3%) PVs, the PFA catheter incorrectly indicated PV-isolation. In 14/213 (6.6%), the PFA catheter incorrectly indicated residual PV-conduction due to high-output pace-capture. Lowering the output to 5 V/1 ms reduced this observation to 0.9% (2/213) and increased the overall accuracy to 97% (206/213). CONCLUSION: A novel multipolar PFA catheter allows reliable endpoint assessment for PVI. Due to its design, far-field sensing and high-output pace-capture can occur. Lowering the pacing output increases the accuracy from 91 to 97%.

Imaging-Based, Patient-Specific Three-Dimensional Printing to Plan, Train, and Guide Cardiovascular Interventions: A Systematic Review and Meta-Analysis.

BACKGROUND: To tailor cardiovascular interventions, the use of three-dimensional (3D), patient-specific phantoms (3DPSP) encompasses patient education, training, simulation, procedure planning, and outcome-prediction. AIM: This systematic review and meta-analysis aims to investigate the current and future perspective of 3D printing for cardiovascular interventions. METHODS: We systematically screened articles on Medline and EMBASE reporting the prospective use of 3DPSP in cardiovascular interventions by using combined search terms. Studies that compared intervention time depending on 3DPSP utilisation were included into a meta-analysis. RESULTS: We identified 107 studies that prospectively investigated a total of 814 3DPSP in cardiovascular interventions. Most common settings were congenital heart disease (CHD) (38 articles, 6 comparative studies), left atrial appendage (LAA) occlusion (11 articles, 5 comparative, 1 randomised controlled trial [RCT]), and aortic disease (10 articles). All authors described 3DPSP as helpful in assessing complex anatomic conditions, whereas poor tissue mimicry and the non-consideration of physiological properties were cited as limitations. Compared to controls, meta-analysis of six studies showed a significant reduction of intervention time in LAA occlusion (n=3 studies), and surgery due to CHD (n=3) if 3DPSPs were used (Cohen's d=0.54; 95% confidence interval 0.13 to 0.95; p=0.001), however heterogeneity across studies should be taken into account. CONCLUSIONS: 3DPSP are helpful to plan, train, and guide interventions in patients with complex cardiovascular anatomy. Benefits for patients include reduced intervention time with the potential for lower radiation exposure and shorter mechanical ventilation times. More evidence and RCTs including clinical endpoints are needed to warrant adoption of 3DPSP into routine clinical practice.

Efficacy and safety of ethanol infusion into the vein of Marshall for mitral isthmus ablation.

INTRODUCTION: Chemical ablation by retrograde infusion of ethanol into the vein of Marshall (VOM-EI) can facilitate the achievement of mitral isthmus block. This study sought to describe the efficacy and safety of this technique. METHODS AND RESULTS: Twenty-two consecutive patients (14 males, median age 71 years) with attempted VOM-EI for mitral isthmus ablation were included in the study. VOM-EI was successfully performed with a median of 4 ml of 96% ethanol in 19 patients (86%) and the mitral isthmus was successfully blocked in all (100%). Touch up endocardial and/or epicardial ablation after VOM-EI was necessary for 12 patients (63%). Perimitral flutter was present in 12 patients (63%) during VOM-EI and terminated or slowed by VOM-EI in 4 and 3 patients, respectively. The low-voltage area of the mitral isthmus region increased from 3.1 cm2 (interquartile range [IQR] 0-7.9) before to 13.2 cm2 (IQR: 8.2-15.0) after VOM-EI and correlated significantly with the volume of ethanol injected (p = .03). Median high-sensitive cardiac troponin-T increased significantly from 330 ng/L (IQR: 221-516) the evening of the procedure to 598 ng/L (IQR: 382-769; p = .02) the following morning. A small pericardial effusion occurred in three patients (16%), mild pericarditis in one (5%), and uneventful VOM dissection in two (11%). After a median follow-up of 3.5 months (IQR: 3.0-11.0), 10 of 18 patients (56%) with VOM-EI and available follow-up had arrhythmia recurrence. Repeat ablation was performed in five patients (50%) and peri-mitral flutter diagnosed in three (60%). CONCLUSION: VOM-EI is feasible, safe, and effective to achieve acute mitral isthmus block.

Leadless pacemaker implantation quality: importance of the operator's experience.

AIMS: Leadless cardiac pacemaker (PM) implantation differs from conventional PM implantation. While the procedure has been considered safe, recent real-world data raised concerns about the learning curve of new operators and their implantation quality. The goal of this study was to investigate the influence of the first operator's experience on leadless PM implantation quality and procedural efficiency. METHODS AND RESULTS: We performed a bicentric analysis of all Micra TPS™ implantations in two large tertiary referral hospitals. We assessed both leadless PM implantation quality based on the absence of complications (requiring intervention or prolonged hospitalization), good electrical performance (pacing threshold ≤ 1.5 V/0.24 ms, R-wave amplitude > 5 mV), and acceptable fluoroscopy duration (<10 min) as well as procedural efficiency in relation to the operator's experience. Univariate and multivariate logistic regression analyses were performed to identify predictors for implantation quality and procedural efficiency. Leadless PM implantation was successful in 106/111 cases (95.5%). Three patients (2.7%) experienced acute complications (one cardiac tamponade, one femoral bleeding, one posture-related PM exit block). Multivariate analysis showed that implantation quality of more experienced first operators was higher [odds ratio 1.09 (95% confidence interval 1.00-1.19), P = 0.05]. Procedural efficiency increased with operator experience as evidenced by an inverse correlation of procedure time, time to the first deployment, fluoroscopy time, and the number of procedures performed (all P < 0.05). CONCLUSION: The operator's learning curve is a critical factor for leadless PM implantation quality and procedural efficiency.

Causes of impaired biventricular pacing in cardiac resynchronization devices with left ventricular sensing.

BACKGROUND: Loss of biventricular stimulation can result in nonresponse to cardiac resynchronization therapy (CRT). Problems associated with the left ventricular (LV) lead and LV sensing can be challenging to detect and their incidence is unclear. The purpose of this study was to investigate mechanisms of loss of biventricular pacing due to LV lead- and LV sensing-associated problems. METHODS: In this bicentric study, CRT patients were surveilled using a novel remote monitoring algorithm from Biotronik (Germany) that registers LV electrograms (EGMs) during intermittent loss of resynchronization. The episodes were analyzed to assess the mechanisms of resynchronization interruptions. RESULTS: We analyzed 582 EGMs from 61 patients. During a median follow-up of 6 months, 59% of the patients had such episodes. The majority of the episodes (61%) were related to inappropriate inhibition of LV pacing, mostly due to upper rate lock-in caused by LV sensing (58%). In contrast, 8% of episodes showed intermittent loss of LV capture, which was identified thanks to LV sensing. The remaining 31% of episodes were due to physiological reasons for resynchronization interruptions (eg, supraventricular tachycardia [18%], premature beats [8%], and others [5%]). Patients with CRT interruption episodes had lower resynchronization rates (median: 98.5% vs 100%, P = .044). CONCLUSIONS: Inadequate programming (active LV sensing with T-wave protection) is the main cause of impaired resynchronization in devices with LV sensing. In general, we recommend the deactivation of the LV T-wave protection function.

High incidence of diaphragmatic myopotential oversensing by a specific implantable cardioverter defibrillator.

INTRODUCTION: Diaphragmatic myopotential oversensing (dMPO) by implantable cardioverter defibrillators (ICDs) is thought to be a rare condition that can be misdiagnosed as lead failure and lead to unnecessary lead replacement. We observed several cases of dMPO in patients with Sorin/LivaNova ICDs (MicroPort Sci.). We sought to systematically assess the incidence of dMPO in patients with Sorin/LivaNova ICDs. METHODS AND RESULTS: A predefined number of 100 consecutive patients with Sorin/LivaNova ICDs were prospectively included in the device clinic of our center. Stored arrhythmia episodes were checked for spontaneous dMPO. In addition, we performed provocation maneuvers by Valsalva. At least one episode of spontaneous or provoked dMPO was seen in 12 (12%) of the 100 patients included in the study (86% males, median age: 66 years). Nine of 89 patients (10%) with true bipolar and 3 of 11 patients (27%) with integrated bipolar sensing configuration were affected. Spontaneous dMPO was observed in 7 of 58 patients (12%) with sensitivity programmed to 0.4 mV and in 2 of 42 patients (5%) with sensitivity programmed to 0.6 mV (not significant). In three patients, dMPO could be provoked with no spontaneous episodes recorded. In two nonpacemaker-dependent patients with a CRT-D, ventricular pacing was temporarily inhibited. No antitachycardia therapy was triggered by dMPO in any patient. CONCLUSIONS: DMPO is frequent in patients with Sorin/LivaNova ICDs, especially with sensitivity programmed to 0.4 mV. It also frequently occurs with true bipolar sensing configuration. DMPO should not be misinterpreted as lead failure to avoid unnecessary lead replacement.

Radiofrequency ablation lesion assessment using optical coherence tomography - a proof-of-concept study.

BACKGROUND: Radiofrequency catheter ablation (RFA) is an effective treatment for atrial fibrillation. However, ablation lesions are usually only assessed functionally. The immediate effect of RFA on the tissue is not directly visualized. Optical coherence tomography (OCT) is an imaging technique that uses light to capture high-resolution images with histology-like quality. Therefore, it might be used for high-precision imaging of ablation lesions. METHODS AND RESULTS: Radiofrequency ablation lesions (n = 25) were produced on the freshly excised left and right ventricular porcine endocardium. A Thermocool ST SF NAV ablation catheter (Biosense Webster Inc) and an EP-Shuttle ablation generator (Stockert GmbH) were used to produce ablation lesions with powers from 10 to 40 W (energies ranging from 100 Ws to 900 Ws). After ablation, the tissue was imaged with a swept source OCT system (at a wavelength of 1300 nm). Subsequently, the ablation lesions underwent the histological analysis. The ablation lesions could be visualized by OCT in all 17 samples with ablation powers ≥20 W, meanwhile, no lesion could be observed in the other eight samples with lower power (10 W). Lesion depths and lesion radiuses, as assessed by OCT, correlated well with those observed on the subsequent histological analysis (Spearman's r = 0.94, P < 0.001 and r = 0.84, P < 0.001). In addition, successful three-dimensional reconstructions of ablation lesions were performed. CONCLUSION: OCT can provide a visual high-resolution assessment of ablation lesions.