bluuebunny/crossref_metadata_2025 huggingface dataset:
Do co-morbidities, frailty and functional status identify patients who may not benefit from ICD therapy?
Authors: Wilson D G , James S X , Power D F , Sharma-Oates A , Lord J M , Roberts P R , Morgan J M
Published: May 2023

Funding Acknowledgements

Type of funding sources: Private grant(s) and/or Sponsorship. Main funding source(s): Boston Scientific ISR lite.

Background

In carefully selected patients, Implantable Cardioverter Defibrillators reduce all-cause mortality by reducing the burden of sudden cardiac death. Most patients who have an ICD implant do not receive life-prolonging therapy from it. Little research has been undertaken to determine which patients benefit the least from ICD therapy. As patients age and accumulate comorbidities, the risk of death increases and the benefit of ICDs diminishes.

Purpose

We sought to evaluate the impact of comorbidity, frailty, functional status on death prior to ICD therapy as this group has the least to gain from ICD therapy.

Methods

A prospective, multicentre, observational study involving 15 English hospitals was undertaken. Patients were eligible for inclusion for the study if they were scheduled to have a de novo, replacement or an upgrade to a high-energy device (transvenous or subcutaneous ICD or CRT-D). Baseline characteristics were collected including age, gender, device type, LV function, medication, baseline bloods if available and were asked to complete a frailty assessment, Fried score; a functional status questionnaire (EQ5D5L), Charlson Co-morbidity Score and EQ5D5L data were calculated.

Results

In total, 662 patients were enrolled, mean age 65.6 (IQR 65-75) years, 77.3% male, 55.9% de novo implants, 33.4% replacements and 10.5% upgrade. Overall, 32% were for a secondary prevention indication, 49.% had a single or dual chamber transvenous ICD, 45.3% had a CRT-D and 5% had an S-ICD) implanted. A total of 63 patients (9.5%) died across this period, of these, 54 died without receiving appropriate therapy. Frailty was present in 83/662 (12.5%) and severe co-morbidity was present in 69/662 (10.4%). The overall survival probability estimated to be 90.2% at 2.5 years, and was 68% in frail patients. Figure 1.

Multivariate predictors of death with no appropriate therapy were identified and a risk score comprising frailty, severe co-morbidity, age >70 years, eGFR <60 ml/min/1.73 m2 EQ5D5L <0.6 was developed. Table 1. The model performance was: sensitivity= 80.7%; specificity = 81.6%; precision 27.3%; accuracy 81.6% and AUC 0.81.

Conclusion

Frailty and severe co-morbidity are powerful, independent predictors of death with no appropriate in ICD/CRT-D recipients.
Clinical predictors of very low defibrillation threshold in the extravascular ICD
Authors: Murgatroyd F , Crozier I , Leclercq C , Clementy N , Amin A , Roukoz H , Nikolski V , Lande J , Degroot P , Boersma L
Published: May 2023

Funding Acknowledgements

Type of funding sources: Private company. Main funding source(s): Medtronic, Inc.

Background

The extravascular ICD (EV ICD) is a 40J device utilising a lead placed behind the sternum and a subcutaneous can in the axilla to achieve defibrillation efficacy, size, and predicted longevity comparable to transvenous devices, as well as providing pause prevention and antitachycardia pacing. In the worldwide EV ICD Pivotal Study, 98.7% of 302 patients completed the defibrillation (DF) testing protocol with a safety margin of ≥10J. In 71.5% of patients, defibrillation was successful at lower energies (20J or 15J). Factors associated with lower energy defibrillation in EV ICD patients have yet to be determined.

Purpose

In this analysis we examine what factors are associated with very low DF thresholds (safety margin ≥20J).

Methods

Multivariate analysis was performed to look for clinical and implant predictors in patients with success at very low energies (15J or 20J, n = 216) versus those in whom either success was achieved at higher energies (2x 30J before or after polarity changes/revisions, n = 82), or DF testing failed (n=4) or was incomplete (n = 4).

Results

24 variables were examined: 18 pre-implant clinical factors (including gender, body measurements, aetiology, LV ejection fraction, medications) and 6 peri-implant electrical measurements. Univariate analysis identified 5 clinical factors and 4 implant measurements as predictors of defibrillation success at very low energy; multivariate analysis with a gate of p <0.1 found 6 factors to be independent predictors (see table).

Conclusions

Certain pre-implant clinical factors and implant details are independent predictors of successful defibrillation at very low energies. If confirmed, these findings suggest that in many cases DF testing at EV ICD implant may not be necessary.
Effects of CRT on atrial and ventricular arrhythmias in patients with HF
Authors: Taleski J , Pocesta B , Janusevski F , Risteski D , Poposka L
Published: May 2023

Funding Acknowledgements

Type of funding sources: None.

Introduction

Cardiac resynchronization therapy (CRT) is an accepted treatment for patients with heart failure (HF). Cardiac arrhythmias present a significant and complex issue in this patient group. Evidence exploring the influence of CRT on cardiac arrhythmias rate variations is limited.

Purpose

Our research investigates the effectiveness of CRT in the treatment of existing and newly diagnosed atrial and ventricular arrhythmias, and impact of epicardial lead position on these arrhythmias rate variations, as well as on the CRT response.

Methods

This single-center, prospective, observational study included 75 consecutive patients admitted for CRT implantation over a 12-month period. All included patients had episodes of atrial and/or ventricular arrhythmias, diagnosed by 12-lead ECG or 24-hour Holter monitoring. Pre-procedural demographic characteristics were collected for all patients, including ECG records, NYHA functional class, echocardiographic assessment of left ventricular ejection function and questionnaire for quality-of-life. During device follow up atrial and ventricular arrhythmias appearance was monitored. Additional assessment of echocardiographic parameters, NYHA - functional class, quality of life and rate of major cardiovascular complications and rehospitalizations was performed.

Results

The mean age of the patients was 62.4 ± 10.3 years, with 74.6% male and 25.3% females. 72% had a non-ischemic HF etiology. Pre-procedural paroxysmal AF was present in 34.7%, persistent AF in 36%, PVCs in 32%, NSVT 16%, and VT in 18,7% patients. 55% of the included patients were responders to CRT. Our results showed decrease in rate of all ventricular arrhythmias, with significant reduction in the percentage of VT (p=0.003), regardless of CRT response. Significant reduction of PVCs and NSVT rate (p=0.012 & p=0.024) was found in the responder group of patients. Regarding AF, our results showed a decrease in the number of AF events in both patient groups, however this was most visible in the responder patients with paroxysmal AF (p=0.057). In CRT responders, left ventricular pacing lead was most commonly located in a lateral branch vein of the CS with middle and mid/lateral position. In terms of quality of life and general condition of the patients, we noticed a significant improvement in the NYHA - functional class (p <0.001), as well as in both parts of the quality-of-life assessment questionnaire (p=0.0135, p<0.001).

Conclusion

CRT is an effective treatment for atrial and ventricular arrhythmias in HF patients, especially in responders to this therapy. LV epicardial lead position proved to be very important influence in the process of LV reverse remodeling, which is in direct correlation of the CRT responders and its effectiveness in reducing the rate of cardiac arrhythmias.
Hemodynamic optimization of cardiac resynchronization therapy by heart sound sensor in pulse generator
Authors: Prinzen F , Westphal P , Luo H , Shahmohammadi M , Delhaas T , Cornelussen R N
Published: May 2023

Funding Acknowledgements

Type of funding sources: Public grant(s) – EU funding. Main funding source(s): EU-HORIZON 2020-International Training Network H2020-MSCA-ITN-2017.

Background

Continuous ambulatory AV-optimization for Cardiac Resynchronization Therapy (CRT) is mainly performed by electrical means.

Objective

Develop an estimation model of cardiac function that uses feedback from a piezoelectric transducer embedded in an internal pulse generator to guide CRT optimization.

Methods

During implantation procedures measurements were performed of left ventricular pressure (LVP) and heart sound waveforms, the latter using the piezoelectric alarm transducer of the device in 22 CRT patients at atrioventricular (AV)-delays of 60-330 ms. Post-hoc, machine learning (ML) was employed to produce models that use heart-sound based features to estimate cardiac function in terms of maximum LVP (LVPmax) and the maximum positive derivative of LVP (LVdP/dtmax). Polynomial curve fitting was used to compare estimated and measured AV-delays with highest LVPmax and LVdP/dtmax.

Results

The figure displays the concept of the study and an example of the measured and estimated optimization curve. With a dataset of ~30,000 beats, ML provided three most suitable features. Using LVPmax, ML-based estimated optimal AV-delays were not significantly different from measured ones (-5.6 ± 17.1ms for LVPmax and +5.1 ± 46.7ms for LVdP/dtmax). The difference in function between the estimated and measured optimal AV-delays was small and not statically significant (1 ± 3mmHg for LVPmax and 9 ± 57mmHg/s for LVdP/dtmax).

Conclusion

Heart sound sensors in devices in combination with ML provide a reliable assessment of absolute LVPmax and LVdP/dtmax and may be used for continuous optimization of AV-delays in CRT patients.
Interaction between atrial-ventricular and ventricular-ventricular delay in CRT
Authors: Bank A , Burns K , Brown C , Johnson K
Published: May 2023

Funding Acknowledgements

Type of funding sources: Foundation. Main funding source(s): United Hospital Medical Education and Research Committee, United Hospital Foundation.

Background

Appropriate programming of atrial-ventricular delay (AVD) and ventricular-ventricular delay (VVD) is critical for delivery of optimal cardiac resynchronization therapy (CRT). However, there is debate over how to determine optimal programming for a given patient. This is complicated by the use of 2 distinct methods of defining the activation timing at a given AVD and VVD used by different device manufacturers.

Purpose

To describe how electrical dyssynchrony is affected by changes in AVD, VVD and the method used to program AVD and VVD.

Methods

We measured electrical synchrony at multiple combinations of AVD/VVD in 41 patients with underlying left bundle branch block (LBBB) using a novel methodology called electrical dyssynchrony mapping (EDM). Electrical dyssynchrony was quantified by cardiac resynchronization index (CRI), calculated as % change in area under the curve between combinations of 9 anterior and 9 posterior surface electrograms.

Results

EDM (Figure 1) shows CRI at multiple combinations of atrial-to-RV-paced, (A-RVp, y-axis) and atrial-to-LV-paced (A-LVp, x-axis) intervals. VVD changes to produce LV preactivation are shown at short and long AVDs using the methods of 2 different CRT device manufacturers: Method 1: fixing A-RVp and shortening A-LVp; and Method 2: fixing A-LVp and lengthening A-RVp. During simultaneous BiV pacing, CRI at short AVD (61.7±20.9) was significantly (p<0.001) greater than at long AVD (46.9±14.0). On average, CRI was significantly greater at short AVD than at long AVD during LV preactivation of 20 or 40 ms (Figure 2). At short AVD, Method 2 resulted in slightly but significantly better CRI at VVD 20 and 40 ms. At long AVD, Method 1 resulted in large and significantly better CRI at VVD 20 and 40 ms.

Conclusions

The interaction between AVD and VVD is complex, and the electrical resynchronization achieved when programming depends on both the AVD at which VVD is programmed, and the programming algorithm used by the device manufacturer. At longer AVDs, Method 1 yields significantly better resynchronization than Method 2 when programming VVD. Studies assessing effects of AVD and VVD programming that involve patients with CRT devices from different manufacturers need to modify programming parameters appropriately in order to accurately interpret results.

Methods

For programming VVD and EDM
Both LBBP and LVSP significantly improve ventricular dyssynchrony and effectivity of LV performance compared to RV apical pacing in heart failure patients with LBBB and an indication to CRT
Authors: Curila K , Stros P , Poviser L , Sussenbek O , Waldauf P , Vondra V , Smisek R , Leinveber P , Jurak P
Published: May 2023

Funding Acknowledgements

Type of funding sources: Public grant(s) – EU funding. Main funding source(s): Supported by the Ministry of Health of the Czech Republic, grant number NU21-02-00584 and by the project National Institute for Research of Metabolic and Cardiovascular Diseases (Programme EXCELES, ID Project No. LX22NPO5104) - Funded by the European Union – Next Generation EU.

Background

Left bundle branch pacing and left septal myocardial pacing (LVSP) are novel methods of CRT in patients with heart failure. However, their exact impact on ventricular synchrony visualized by noninvasive assessment and the LV performance effectivity is unknown.

Aims

To compare ventricular synchrony and a change in blood pressure values between nonselective left bundle branch pacing (nsLBBP), LVSP, and RV apical pacing (RVAP) in heart failure patients.

Methods

In patients with CRT indication and LBBB, a lead was placed in the left septal area, where the transition between nsLBBP and LVSP was observed during decremental output pacing. Another lead was placed in the RV apex. UHF-ECG was used to assess ventricular synchrony during RVAP, nsLBBP, and LVSP. Dyssynchrony parameter e-DYS was calculated as an absolute value of the time difference between the first and last activation. Systolic blood pressure measurements were obtained invasively from the radial artery during VVI pacing at rates ten beats/minute higher than spontaneous rhythm. The protocol included multiple transitions between RVAP, nsLBBP, and LVSP.

Results

The study protocol was finalized in six patients; mean age 67 years, LVEF 33%, 3 had ischemic cardiomyopathy, and QRSd during spontaneous LBBB was 172±8 ms. QRSd was prolonged to 182±10ms during RVAP and shortened to 145±12 ms and 149±13 ms during nsLBBP and LVSP, respectively. The dyssynchrony parameter e-DYS shortened from 46±18 ms during RVAP to 1±16 ms during nsLBBP and 12±13 ms during LVSP, p < 0.05 for RVAP vs. nsLBBP and LVSP, and p = 0.4 for nsLBBP vs. LVSP. Both nsLBBP and LVSP led to a significant increase in the systolic blood pressure compared to RVAP (9±1 mmHg and 10±1 mmHg for nsLBBp and LVSP vs. RVAP, p < 0.001, respectively. nsLBBP produced slightly higher systolic blood pressure than LVSP (mean difference 2±1 mmHg, p = 0.005.

Conclusion

In patients with LBBB and CRT indication, both nsLBBp and LVSP significantly reduce ventricular dyssynchrony and lead to better effectivity of the LV performance compared to RV apical pacing.
Left bundle branch area pacing produces more physiological ventricular activation than biventricular pacing in patients with heart failure and LBBB
Authors: Sussenbek O , Rademakers L , Waldauf P , Jurak P , Stros P , Poviser L , Vesela J , Plesinger F , Halamek J , Smisek R , Leinveber P , Curila K
Published: May 2023

Funding Acknowledgements

Type of funding sources: Public grant(s) – EU funding. Main funding source(s): National Institute for Research of Metabolic and Cardiovascular Diseases, Programme EXCELES, Ministry of Health of the Czech Republic, grant number NU21-02-00584.

Introduction

Biventricular pacing (BiV) is an established treatment for patients with heart failure and dyssynchronous ventricular activation. Left bundle branch area pacing (LBBAP) appears to be a promising alternative to BiV-CRT. To date, there is insufficient data regarding their effect on the reduction of ventricular dyssynchrony.

Purpose

To compare ventricular synchrony during spontaneous rhythm, BiV and LBBAP in patients with heart failure, reduced left ventricular ejection fraction (LVEF), and LBBB using ultra-high-frequency ECG (UHF-ECG).

Methods

This was a retrospective analysis of consecutive patients with indication to CRT from two centers. It included patients with heart failure, QRS of LBBB morphology, and LVEF ≤ 40%, treated by BiV and/or LBBAP-CRT. UHF-ECG data were obtained during spontaneous and paced rhythms. These parameters were calculated: eDYS (time difference between the first and last activation), Vdmean (average of V1-V8 local depolarization durations) and QRSd (measured from pacing artifact).

Results

Analyzes were performed on 80 spontaneous rhythms, 39 biventricular captures and 64 LBBAP, obtained from 80 patients. Their mean age was 74±10 years, 61% were men, mean LV ejection fraction was 31±9 %, and 32% had ischemic cardiomyopathy. Both BiV and LBBAP-CRT significantly reduced QRSd compared to the spontaneous rhythm (from 172 ms, 95% CI [168;176] to 146 ms [141;152] during BiV and 143 ms [139;149] during LBBAP). Also, the eDYS and Vdmean were significantly reduced by both BiV and LBBAP-CRT, i.e., the eDYS from 82 ms [76;86] during LBBB to 33 ms [28;37], p<0.001 during biventricular pacing and to 24 ms [20;28], p<0.001, during LBBAP and Vdmean from 71 ms [68;73] to 59 ms [56;61], p<0.001 during BiV and to 53 ms [51;55], p<0.001 during LBBAP. Although the QRSd did not differ between LBBAP and biventricular pacing (143ms [139;148] vs 146ms [141;152], p=NS), LBBAP compared to BiV led to significantly shorter eDYS (24ms [20;28] vs 33ms [28;38]; p<0.008 and Vdmean (53ms [51;55] vs 59ms [56;61], respectively; p<0.003}.

Conclusions

In patients with heart failure, LBBB and reduced LVEF, both BiV and LBBAP CRT significantly reduce ventricular dyssynchrony compared to the spontaneous rhythm. Our results indicate that LBBAP is associated with more physiological ventricular activation than BiV-CRT.
Ventricular dyssynchrony assessed by ultra-high-frequency electrocardiography predicts the response to biventricular cardiac resynchronization therapy
Authors: Leinveber P , Lipoldova J , Nagy A , Matejkova M , Meluzin J , Novak M , Jurak P , Halamek J , Plesinger F , Smisek R , Waldauf P , Vesela J , Mizner J , Curila K
Published: May 2023

Funding Acknowledgements

Type of funding sources: Public grant(s) – National budget only. Main funding source(s): Supported by the European Regional Development Fund - Project ENOCH No.CZ.02.1.01/0.0/0.0/16_019/0000868, by the project National Institute for Research of Metabolic and Cardiovascular Diseases (Programme EXCELES, ID Project No. LX22NPO5104) - Funded by the European Union – Next Generation EU, by the Ministry of Health of the Czech republic, grant number NU21-02-00584, and by the CAS project RVO:68081731.

Background

Ultra-High-Frequency ECG (UHF-ECG) visualizes ventricular dyssynchrony during spontaneous and paced rhythms. It is unknown whether the UHF-ECG can be used to predict the response to Biventricular cardiac resynchronization therapy (CRT) in patients with heart failure and wide QRS complex.

Purpose

To show a predictive value of UHF-ECG dyssynchrony parameters in patients with an indication of Biventricular CRT.

Methods

This prospective study included consecutive patients with heart failure NYHA II-III, LVEF ≤ 35%, and QRS duration > 120 ms of nonRBBB morphology. All patients received biventricular CRT. Clinical data, UHF-ECG ventricular dyssynchrony assessment were done before, and echocardiography also six months after the CRT. A positive response was defined by a change in LVESV ≥ 10%. Ventricular dyssynchrony parameter e-DYS was defined as a difference between the first and last UHF-ECG ventricular activation.

Results

The study population included 92 patients of mean age 66±9 years, 76% men, LVEF 24±9%, and 45% with ischemic cardiomyopathy. The average change of the LVEF after six months of CRT was 5% and was greater in non-ischemic than ischemic CMP (7% vs. 3%, p < 0.001). 29% of the patients were nonresponders to CRT by the LVESV change. The optimal value of e-DYS to predict response after CRT was 47 ms (sensitivity 78%, specificity 79%). In univariate analysis, the e-DYS > 47 ms, QRSd ≥ 150ms, female sex, presence of non-ischemic heart disease, and Strauss LBBB were significant predictors of response; however, after multivariate analysis, only e-DYS > 47 ms remained significant predictor of response after CRT (p = 0.008).

Conclusion

In nonRBBB patients with heart failure and CRT indication, UHF-ECG electrical ventricular dyssynchrony during the spontaneous rhythm is the predictor of echocardiographic response to CRT.
Impact of clinical expertise and choice of wearable device on accuracy to detect atrial fibrillation via single-lead ECGs
Authors: Weidlich S , Mannhart D , Serban T , Krisai P , Knecht S , Du Fay De Lavallaz J , Schaer B , Osswald S , Kuehne M , Sticherling C , Badertscher P
Published: May 2023

Funding Acknowledgements

Type of funding sources: None.

Background

Manual interpretation of single-lead ECGs (SL-ECG) is often required to confirm a diagnosis of atrial fibrillation (AF). However, accuracy to detect AF via SL-ECGs may vary according to clinical expertise and choice of the wearable device.

Aims

To compare the accuracy to detect AF via single-lead ECG from five different wearable devices (Apple Watch, Fitbit Sense, KardiaMobile, Samsung Galaxy Watch, Withings ScanWatch) between cardiologists, internal medicine (IM) residents, and medical students.

Methods

In this prospective study, invitations to an online survey were distributed via digital invitations among physicians from major Swiss hospitals and medical students from Swiss universities. Participants needed to classify 50 SL-ECGs (from 10 patients and 5 different devices) into three categories: sinus rhythm, AF, or inconclusive. This classification was compared to the diagnosis from an almost simultaneously recorded 12-lead ECG interpreted by two independent cardiologists. In addition, participants were asked to choose the best/worst quality/readability of each manufacturer’s SL-ECG. (Figure A)

Results

Overall 450 participants rated 10’865 SL-ECGs. Sensitivity and specificity for the detection of AF via SL-ECG was 75% and 92% for cardiologists, 70% and 86% for IM residents, 55% and 65% for master medical students (year 4-6) and 45% and 58% for bachelor medical students (year 1-3), p<0.001, (Figure A). Participants which stated prior experience in interpreting SL-ECGs demonstrated a sensitivity and specificity of 65% and 81% compared to a sensitivity and specificity of 56% and 67% for participants with no prior experience in interpreting SL-ECGs, p<0.001. Of all participants, 107 rated all 50 ECGs. Diagnostic accuracy of the first five interpreted SL-ECGs was 60% (IQR 40-80%) and diagnostic accuracy of the last five interpreted SL- ECGs was 80% (IQR 60-90%), p<0.001. No significant difference in the accuracy of AF detection was seen between the 5 different wearable devices, p=0.58. 203 participants (45%) and 226 participants (50 %) ranked SL- ECGs from the Apple Watch as the best quality and readability, respectively.

Conclusion

SL-ECG can be difficult to interpret. Accuracy to correctly identify AF depends on clinical expertise, while the choice of the wearable device seems to have no impact.
Value of implant-based telemonitoring in the high-risk population of ventricular assist device patients
Authors: Guckel D , El Hamriti M , Rojas Hernandez S , Fox H , Costard-Jaeckle A , Gummert J , Fink T , Sciacca V , Braun M , Khalaph M , Imnadze G , Schramm R , Morshuis M , Sommer P , Sohns C
Published: May 2023

Funding Acknowledgements

Type of funding sources: None.

Background

Telemonitoring of heart failure (HF) patients is an evolving field. Prior studies presented promising results. However, the relevance of telemonitoring in the specific cohort of end-stage HF patients on ventricular assist device (VAD) therapy has not been analysed yet.

Purpose

This study aimed to evaluate the benefit of daily implant-based multiparameter-telemonitoring in high-risk HF-patients on VAD therapy with an implantable cardioverter-defibrillator (ICD) or a cardiac resynchronization defibrillator (CRT-D) including telemonitoring function. Beyond that, patients’ outcome and complication rates were evaluated.

Methods

A total of 30 end-stage HF-patients (65 ± 10 years, 89 % male) with a VAD and an ICD or a CRT-D with telemonitoring function were included in this observational single center study. Long-term follow-up data (4.28 ± 2.62 years) were assessed.

Results

All patients (n=30, 100%) received daily ICD or CRT-D telemonitoring. In the majority of patients (73%, n=22) the telemedical center had to take actions a mean of 3 times. Most events (84%, n=45) were identified within 24 hours. An acute alert due to sustained ventricular arrhythmias (VAs) occurred in 13 patients (65%) with 46% of them (n=6) requiring a shock delivery. Eight patients (62%) were hospitalized due to symptomatic VAs. Inadequate shocks were recognized in 3 patients (23%). In 12 patients (92%) immediate medication adjustments were recommended. Relevant lead problems were revealed in 13 patients (43%) with 6 patients (46%) undergoing consecutive lead revisions. Device-reprogramming was recommended in 50% of all VAD-patients (n=15). Compared to HF-patients without remote monitoring, daily telemonitoring significantly reduced the number of in-hospital device controls by 44% (p<0.01).

Conclusions

Daily implant-based-telemonitoring increased patient safety as it allowed for pre-emptive interventions and an immediate detection of cardiac arrhythmias and device/lead problems. Even in this high-risk HF-patient population, telemonitoring significantly reduced the number of in-hospital device-controls. Further studies are warranted to confirm these initial observations.
Incidental findings at FDG PET/CT in carriers of cardiovascular implantable electronic devices
Authors: Diemberger I , Mei R , Massaro G , Fraccascia N , Vetrone L , Bezzi D , Calderoni L , Marinelli V , Bonfiglioli R , Valzania C , Nanni C , Fanti S
Published: May 2023

Funding Acknowledgements

Type of funding sources: None.

Background

FDG-PET/CT clinical use for cardiovascular implantable electronic device (CIED) infection is of relevant importance, since it provides information about presence and extension of the infection. However, asymptomatic patients with incidental FDG uptake on CIED are challenging.

Purpose

The primary objective of this observational study was to assess the diagnostic role of FDG PET/CT in patients without a suspicious of CIED infection. The secondary objective was to identify qualitative and semiquantitative predictors of CIED infection.

Methods

From 2017 to 2019 all FDG-PET/CT scans of CIED patients were analysed, the indications were a suspicious of CIED or non-cardiovascular infection, or oncological follow up. Four expert nuclear medicine physicians blindly reviewed all scans, focusing on FDG uptake in pocket and/or in extracardiac lead parts. They reported standardized uptake values (SUV), liver and blood pool target-to-background ratios, metabolic tumour volume (MTV). 6 months follow up after PET/CT scan was performed for eventual CIED extraction because of infection.

Results

320 FDG-PET/CT scans were considered. Median age was 74 [33-94] years, 219/320 (68%) males. 122/320 (38%) scans presented FDG uptake around pocket and/or extracardiac lead parts; and 65/320 (20%) scans reported suspicious uptake. We identified these cut-off criteria as predictors of CIED extraction: TARGET SUV max >2.6 (sensitivity 71%, specificity 89%), LIVER-TARGET SUV max >1.3 (sensitivity 68%, specificity 89%). Both these values also demonstrated to be good predictors of CIED infection after 6 months follow up (p<0,001).

Conclusion

FDG-PET/CT uptake in asymptomatic CIED patients is underestimated and may be related to subtle CIED infection. By introducing high-specific SUV cut-off values, a considerable impact on patient management is expected.
Does radiotherapy effect the voltage output of cardiac implantable electronic devices (CIEDs)?
Authors: Fenwick A , Manley S , Lowrey M , West N , Shepherd E
Published: May 2023

Funding Acknowledgements

Type of funding sources: None.

Purpose

Current guidelines for the management of patients undergoing radiotherapy with cardiac implantable electronic devices (CIEDs) were published in 1994. They recommend that the total dose received by the device should be estimated before treatment, devices should not be placed in the direct radiation beam and the cumulative dose should not exceed 2Gy to any part of a pacemaker (0.5Gy for ICDs). This is because radiotherapy can cause malfunctions in cardiac implantable devices. At doses higher than this, relocation of the device is recommended. Device malfunctions are suggested to correlate with a beam energy of ≥10MV. One malfunction that poses a high risk to patients is a change in voltage output amplitude. This study assessed if low-energy flattening filter and high energy flattening filter-free photon beam radiation caused a change in the voltage output amplitude of cardiac implantable devices.

Method

40 cardiac implantable devices were divided into two treatment groups and irradiated in vitro with a cumulative 48Gy dose of 6MV radiation at 600MU/min in 8 fractions or a 48Gy dose of 10MV radiation at 2400MU/min. The voltage output amplitude of all devices was collected using an oscilloscope and an amplitude change of ≥25% was classed as a clinically significant malfunction.

Results

In the 6X treatment group, 0/19 devices showed a clinically significant change. No statistical significant difference was found between the median peak voltage output amplitude before fraction 1 and after fraction 8 (U = 149.5, p = 0.3733, n =19). In the 10MV treatment group, 2/21 devices showed a clinically significant change. These devices showed a voltage output amplitude increase of 28.07% and 36.97%. However, no statistical significant difference was found between the median peak voltage output amplitude before and after radiation (U = 149.5, P = 0.0746, n = 21). Although insignificant, there was clearly a larger change across all devices in the 10FFF group compared to the 6X group. Results were not statistically significant between manufacturers but defibrillators were statistically significantly more likely to malfunction than pacemakers.

Conclusion

The recommended dose of radiotherapy for patients with a CIED should be carefully considered on an individual basis. Due to neutron production and its effect on rapid access memory (RAM) and complementary metal oxide semiconductor (CMOS) circuitry, high-energy ≥10MV radiation can affect the voltage output amplitude, despite its statistical insignificance. Based on this limited report it is unlikely that the voltage output amplitude of CIEDs will be affected by clinically relevant doses of radiotherapy, but it may have long term implications on battery life. These results could eliminate the risk of increased infection due to relocation of devices, provide patients with optimised treatment and enable a more effective service for improved patient management.
Blood stream infection in patients with implantable-cardioverter defibrillator admitted to non-cardiology units: incidence, diagnostic work-up and outcome
Authors: Oezkartal T , Demarchi A , Conte G , Pongan D , Caputo M L , Klersy C , Bernasconi E , Granger C B , Auricchio A
Published: May 2023

Funding Acknowledgements

Type of funding sources: None.

Background

There is limited knowledge on the incidence of blood stream infections (BSI) in patients with implantable cardioverter defibrillators (ICDs) or cardiac resynchronization therapy devices (CRTs), as well as about the diagnostic work-up and outcome when these patients are admitted to non-cardiology units.

Purpose

We assessed the incidence of BSI in patients with an ICD or CRT, evaluated the diagnostic work-up performed, and investigated the outcome.

Methods

This is a single-center, retrospective cohort analysis of all 515 patients implanted with a de-novo ICD or CRT between 2012 and 2021 at our centre, and subsequently admitted to a non-cardiology unit of any public hospital in Canton Ticino with a BSI (≥ 2 positive blood cultures). Device infection was defined according to the 2019 International Cardiac Implantable Electronic Device (CIED) Infection Criteria.

Results

A total of 43 patients were diagnosed with BSI during a median follow-up of 48 months (IQR 24-78 months). Incidence rate for BSI was 19 (95%-CI 14 – 26) and 23 (95%-CI 14 – 35) per 1000 patient-years for ICDs and CRTs, respectively. The most common source for BSI was urinary tract infection (21%), which was mostly caused by gram positive pathogens (68%) with coagulase-negative staphylococci being the most frequent one (39%). Definite CIED infection rate in patients presenting with BSI was 11.6% (see table). The majority of patients (56%) had no cardiac imaging including transthoracic or transesophageal echocardiography; a PET-CT was performed in only 4 patients (9%). Nearly all patients (86%) were treated with short-term antibiotics; in contrast, system extraction (2.3%) and chronic antibiotic therapy (4.7%) were rarely performed. Throughout the entire follow-up period, patients with BSI had a 8-fold higher probability (HR 7.8, 95% CI 4.8-12.7; p<0.001) of all-cause mortality compared to those without BSI.

Conclusions

Awareness in non-cardiology units about possible device infection in patients with BSI is rather low leading to limited diagnostic work-up and ultimately to a high mortality rate of these patients.
Initial results of a prospective, multicenter study on the use of a biosynthesized cellulose membrane as a separation in de novo CIED implantations
Authors: Starck C T , Falk V , Kaemmel J , Lanmueller P , Heck R , Huemer M , Attanasio P , Nagel P , Butter C
Published: May 2023

Funding Acknowledgements

Type of funding sources: Other. Main funding source(s): Public Grant: EIC Accelerator pilot –SME Instrument (H2020-EIC-SMEInst-2018-2020)

Private Company: Hylomorph AG

Background

Fibrosis is the result of foreign body reaction against the hardware of cardiac implantable electronic devices (CIEDs). Generator pocket fibrotic adhesions increase the complexity and risks of CIED revision surgeries. There is limited evidence that synthetic or ex vivo resorbable envelopes can prevent or reduce fibrosis.

Objective

We conducted a multicenter, prospective, single-arm, interventional study of microengineered biosynthesized cellulose (BC) as separation layer for CIED pockets. Patients who were undergoing a CIED de novo implantation were included to receive the protective device. The primary end point was the maintenance of a detectable barrier between the CIED generator and the surrounding tissue at 12 months. The secondary end point for safety was procedure-related or system-related complications within 12 months.

Methods

High resolution ultrasound (HRUS) imaging of the protective layer, the CIED and the surrounding tissue of the generator pocket were collected at the day of implant, and at one, six-, and twelve-months follow-up visits in 35 patients (of 46 recruited). The images were individually processed and analyzed.

Results

HRUS imaging allowed the reproducible detection of (1) the CIED interface as fiducial reference marker, (2) the densification of the surrounding tissue and (3) the segregation between the two. A detectable separation between the CIED and the surrounding tissue was identified in all patients at all follow-up visits demonstrating the enforcement of a durable and stable barrier. The evolution of HRUS signal intensity indicated a time-dependent densification compatible with the buildup of fibrotic tissue around the generator. The thickness of this tissue was measured rendering values below 1 mm. Mean time for cellulose membrane application was 7.5±4 minutes. Investigational device related major complications were 0%.

Conclusion

Adjunctive use of an antifibrotic device established a durable separation between the CIED and the surrounding soft tissue in the generator pocket without a significantly higher incidence of complications or a relevantly increased procedural time. HRUS imaging indicated a limited buildup of denser tissue around the generator and no adhesions inside the cellulose membrane. Altogether these results suggest that BC may be beneficial for post-implantation pocket health as an alternative to envelopes of synthetic or animal origin and may enable easy pocket access in revision procedures.
The association of P-terminal force value and increased risk for ischemic stroke among admitted patients in a tertiary hospital: a retrospective case-control study
Authors: Manalili M K C , Declaro R A D , Dionisio J D
Published: May 2023

Funding Acknowledgements

Type of funding sources: None.

Background

Cerebrovascular disease is the second leading cause of mortality in the Philippines, with prevalence of 0.9 to 2.6%.³ However, recent researches show that left atrial abnormality, even without atrial fibrillation, increases risk for ischemic stroke.

Purpose

This study aims to determine the association of P-terminal force value in V1 (PTFV1) and ischemic stroke. Secondary objectives are to elucidate the relationships of PTFV1 and dilated left atrium (LA), and dilated LA and ischemic stroke.

Methods

This is a retrospective case-control study which included adult Asian patients managed as first-time ischemic stroke, with an age-, gender- and co-morbidity-matched control group. A total of 290 patients were evaluated. Binary logistic regression was used in the analysis of the primary outcome, while independent T-test and chi-square test were utilized for the secondary outcomes.

Results

PTFV1 and ischemic stroke had a statistically significant positive association. Every 1 unit change of PTFV1 confers 1.7% increased risk for ischemic stroke. Furthermore, a higher PTFV1 was significantly correlated with dilated LA. However, there was no significant association between dilated LA and ischemic stroke.

Conclusion

PTFV1 confers an easier way to diagnose patients with left atrial abnormality, and stratify those with increased risk for ischemic stroke.
Surpassing the complex substrate of accessory pathways ablation in ebstein anomaly
Authors: Laranjo S , Lourenco G , Portugal G , Cunha P , Sousa L , Trigo C , Pinto F , Ferreira R , Oliveira M
Published: May 2023

Funding Acknowledgements

Type of funding sources: None.

Background and Aims

Data regarding long-term follow-up of radiofrequency catheter ablation (RFCA) of accessory pathways (APs) in patients (P) with Ebstein's anomaly are limited. This type of procedure is considered challenging due to multiple and broad APs. The present study aimed to describe the electrophysiological features of APs in P with Ebstein's anomaly, and report our RFCA experience with an open-window electroanatomic 3D mapping using high-density mapping catheters in these patients.

Methods and results

A retrospective study of 15 consecutive Ebstein anomaly P with APs who underwent an electrophysiologic study and RFCA from 2013 to 2022. There were a total of 21 manifested non-decremental APs. APs were mainly located on the posterior, posteroseptal, and posterolateral tricuspid annulus. The index procedure was unsuccessful in six P, with the need for a redo procedure. This redo procedure was performed with a high-density catheter (Pentaray, Biosense or HD-Grid, Abbott), using the open-window annotation algorithm (Abbott's NavX Precision or BiosenseWebster Carto3), guided by CT integration and intracardiac echo. Broad APs were documented in all these six patients (width range 2-15cm) and successfully ablated. In one P, the AP encompassed ¾ of the TA, resulting in a complete AV block after the procedure, having fitted a pacemaker. All P remained free from tachycardias during 15±8 months of follow-up, with the majority (n=12) having sinus rhythm with morphology of right bundle branch block, while three patients showed a narrow QRS.

Conclusions

RFCA in P with Ebstein anomaly is challenging, but safe, and has a high long-term success rate. APs are predominantly right-sided, manifest and localized to the lower half of the anatomic tricuspid annulus. Some APs have broad widths. In this population, the new high-resolution mapping catheters, using the open-window annotation, produce an improved anatomical resolution of the APs, increasing the odds of success.
Prognostic significance of addition of electrocardiographic findings to the MAGGIC heart failure risk score
Authors: Dogan O , Ikitimur B , Barman H A
Published: May 2023

Funding Acknowledgements

Type of funding sources: None. Main funding source(s): Researchers

Background

The Meta-analysis Global Group in Chronic Heart Failure (MAGGIC) is a scoring system that is easy to use in outpatient or inpatient settings and was developed to predict the survival of heart failure (HF) patients after hospitalization.

Aim

This study aims to determine the prognostic significance of MAGGIC risk score combined with electrocardiography (ECG) parameters in decompensated patients with heart failure with reduced left ventricular ejection fraction (HFrEF) who were hospitalized for worsening HF.

Methods

A total of 562 HF patients with New York Heart Association (NYHA) II-IV functional class who were discharged after hospitalization for decompensated HF between 2013 and 2018 in a single center were included. MAGGIC risk scores of all participating patients were calculated according to baseline characteristics gathered using data from the initial hospitalization for HF. In addition, electrocardiographic findings of all patients were examined.

Results

During the follow-up period (4.5 ± 1.2 years) 177 patients died. MAGGIC scores were observed to be higher in non-survivors compared to surviving patients (28.69 ± 7.01 vs. 22.82 ± 6.05, p < 0.001). After a multivariate analysis, MAGGIC score (OR:1.090, p < 0.001), development of cardio-renal syndrome (OR:2.035, p < 0.001), presence of left bundle branch block (LBBB) (OR:1.931, p < 0.001), atrial fibrillation (AF) (OR:1.817, p < 0.001), and fragmented QRS (fQRS) (OR:1.671, p = 0.002) on ECG were found to be independent predictors of mortality. While the MAGGIC score was shown to predict mortality (AUC = 0.739), its predictive power was improved when combined with AF (AUC = 0.752), LBBB (AUC = 0.745), and fQRS (AUC = 0.757) respectively, as well as in the combined final model (MAGGIC score, AF, LBBB, fQRS) (AUC = 0.787).

Conclusions

Our findings showed that addition of electrocardiographic findings to the MAGGIC heart failure risk score has prognostic significance in decompensated patients with HFrEF.
Explainable Paroxysmal Atrial Fibrillation Diagnosis Using Electrocardiogram with Artificial Intelligence
Authors: Lee K H , Ko B G , Jin Y B , Chang W J
Published: May 2023

Funding Acknowledgements

Type of funding sources: Public grant(s) – National budget only. Main funding source(s): National Research Foundation of Korea (NRF) funded by the Korea government (MSIT)

Background

Paroxysmal atrial fibrillation (PAF) is common among patients with cryptogenic stroke or transient ischemic attack, and has a silent nature. Therefore, robust and reliable early detection of atrial fibrillation would be valuable for managing cardiovascular comorbidities. Therefore, robust and reliable early detection of atrial fibrillation would be valuable for managing cardiovascular comorbidities. Despite many efforts to predict or detect atrial fibrillation, an adequate explanation for estimation remains problematic.

Method

We present a statistical prediction model employing a deep-learning approach to identify a PAF from normal electrocardiogram (ECG), and interpret their causes. Based on 552,372 12-lead ECG data of 318,321 patients, we show that an AI-based model can capture the features of atrial fibrillation during normal sinus rhythm using ECG and additional characteristics. As a result of applying our labelling method, only 26,541 ECGs (4.8%) were annotated with PAF. We also applied Layer-wise Relevance Propagation(LRP) algorithm to investigate the regions of the ECG that primarily affect the discrimination of PAF.

Results

The performance of our model was evaluated as the area under the curve (AUC) of the receiver operating characteristic (ROC) curve. The AUC for predicting PAF was 0.910. The predictive performance according to the class was 0.837 in the negative prediction and 0.705 in the positive prediction. The sensitivity analysis results showed that the difference in PAF prediction information for each lead was not significant. Among the features obtained from ECG, the PR interval and QT interval were significant explaining factors for the prediction of PAF, and this fact was confirmed by visualizing the ECG data using the LRP algorithm.

Conclusion

We expect that the discrimination of undetected atrial fibrillation can be used as a pre-emptive assistive tool to provide probabilistic predictions for the screening of PAF and could be enables insights into the cardiac dysfunction.
Impact of novel insertable cardiac monitoring system on real-world cardiac device clinic workflow
Authors: Rosemas S C , Archer N , O'connor E , Coughlan F
Published: May 2023

Funding Acknowledgements

Type of funding sources: None.

Background

Insertable cardiac monitors (ICMs) continually monitor for cardiac arrhythmias, enabling appropriate therapeutic intervention. However, clinic workload to manage ICM patients can be significant. The recent LINQ II ICM system was designed with several features to streamline clinic practice, including remote reprogramming and on-demand data pull capabilities, tablet-based clinician device programmer, smartphone app-based patient monitor, patient management service, and elective data triaging service.

Purpose

To characterize the impact of the LINQ II ICM system on clinic workload compared to previous ICM systems.

Methods

A detailed workflow survey was taken by clinicians at 66 unique cardiac device clinics across UK/Ireland. The total number of ICM patients per clinic averaged 563 patients (median = 500). Respondents included cardiac physiologists (94%), cardiac nurses (4%), and physicians (2%).

Results

Overall, 82.5% of respondents reported that the LINQ II ICM system is more efficient compared to previous ICM workflow, with a total clinic time savings of 9.3 hours/week (Table). Use of a tablet-based device programmer was estimated to save 19.9 minutes per ICM patient during the initial device insertion and activation, while the patient management service saved 30.6 minutes per new patient on monitor set-up and education. Two-thirds (68.6%) of respondents reported that app-based patient monitoring increases efficiency of remote monitoring, attributable to fewer disconnected monitors and reduced patient calls due to information available in the app (e.g., device battery life, data transmission status). The majority (85.7%) felt that remote reprogramming increases efficiency, as remote reprogramming was estimated to save an average 20.0 minutes of staff time compared to an in-clinic reprogramming. More frequent reprogramming of device alerts also led to an average 13.5% reduction in the rate of non-actionable ICM alerts, and overall 43.1% fewer in-person clinic visits.

Conclusions

New ICM system features appear to streamline the clinic workflow associated with managing ICM patients, freeing up valuable clinician time to devote to patient care activities.