bluuebunny/crossref_metadata_2025 huggingface dataset:
A leadless ventricular pacemaker providing atrioventricular synchronous pacing in the real-world setting: acute results from the Micra AV post-approval registry
Authors: Clementy N , Chinitz J , Marijon E , Haeberlin A , Winter S , Iacopino S , Curnis A , Breitenstein A , Hussin A , Mela T , El-Chami M , Roberts P R , Piccini J P , Stromberg K , Garweg C
Published: May 2023

Funding Acknowledgements

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

Introduction

Advances in leadless pacemaker technology have enabled accelerometer based atrioventricular synchronous (AVS) pacing by sensing atrial mechanical contraction. However, acute safety performance of these devices in real-world clinical practice has not been assessed.

Objectives

To report the acute performance of the Micra AV transcatheter pacemaker from the worldwide Micra AV post-approval registry (PAR).

Methods

The Micra AV PAR is an ongoing prospective single-arm observational study designed to assess the safety and effectiveness of the Micra AV system in the real-world setting. Patients enrolled in the Micra AV PAR will be followed for 3 years. For the present interim analysis, baseline characteristics, total AV synchrony index (sum of %AM-VP, %AM-VS, and AV conduction mode switch percentage), and major complications occurring within 30-days of implant were summarized and compared to a historical cohort of 2,667 transvenous dual chamber (TV-DC) pacing patients.

Results

The device was successfully implanted in 797 of 802 patients (99.4%) at 99 centers. Mean age was 74.1±15.1 years and 42.3% were female. The most common pacing indication was AV block (55.7%). Comorbidities included diabetes (29.7%), CAD (22.8%), and heart failure (12.1%), with 31.3% precluded from transvenous device therapy. Micra AV patients were on average older (74.1 vs. 71.1 yrs, P<0.0001) and had a significantly higher incidence of renal disease (22.3% vs. 9.8%, P<0.0001). Major complications occurred in 2.6% of Micra AV patients and in 7.1% TV-DC patients (P<0.001, Figure). The reduction in major complications was largely driven by the absence of pneumothoraces and lead dislodgements among Micra AV patients. Of the 309 patients programmed to VDD mode with at least 30 days of device follow-up, the median AV synchrony index was 86.0% (IQR: 69.2% - 97.2%). Mean A4 amplitude was 2.1±1.6 m/s2 post-implant and 2.2±1.7 m/s2 at follow-up (P=0.57) in 308 patients with paired assessments.

Conclusions

The Micra AV leadless pacemaker was implanted with a high rate of success in patients with a high co-morbidity burden, with a significantly lower rate of acute complications relative to dual-chamber transvenous pacemakers despite patients being older and having a higher incidence of renal disease. Longer-term performance will continue to be assessed in this ongoing trial.
A tertiary centre experience of routine exercise testing as part of subcutaneous ICD vector mapping
Authors: Hall P , Walton J , Patel P A , Leyva-Leon F
Published: May 2023

Funding Acknowledgements

Type of funding sources: None.

Introduction

The pre-implant patient screening process (vector mapping) for subcutaneous defibrillators (S-ICD) seeks to determine eligibility for implantation. It broadly requires at least one of three available vectors (primary, secondary or alternate) to pass under all conditions to mitigate risk of inappropriate device therapies. Vector mapping protocols currently require only supine and sitting/standing ECG. However, the standard operating procedure (SOP) in our centre also includes mapping at peak exercise, actioned after audit data highlighted an association between exercise and sensing complications (T and R wave changes, rate-related bundle branch block and noise/myopotential over-sensing).

Aim

To determine whether routine exercise testing during screening alters the outcome of vector mapping, and whether this correlates with inappropriate therapies post-implant.

Method

This was a single-centre retrospective study of 121 patients (79% male, mean BMI 29) who completed S-ICD vector mapping between October 2016 and August 2022. 10 patients were excluded as they were unable to tolerate exercise. Emblem automated screening tool (AST) and AST 2.0 was used to complete vector mapping and a revised SOP was devised in conjunction with their technical support team. Post- implant vector programming was based on device optimisation algorithms rather than exercise-inclusive screening recommendation, which provided additional observational data only.

Results

75% were primary prevention devices and the 3 most prevalent aetiologies were dilated (22%), ischaemic (20%) and hypertrophic (18%) cardiomyopathies. In 29.7% (33/111) of participant’s, inclusion of exercise screening altered vector mapping success: The alternate vector saw the largest decrease (23.2%) in successful mapping once exercise was incorporated (69 participants passed supine and sitting/standing, 16 of those failed post-exercise), followed by secondary 13.1% (13/99) then primary 3.9% (4/103) – see Figure 1.

Further retrospective analysis showed that in 16.2% (18/111) of patients, post-implant vector selection opposed screening recommendation. 6 of these patients experienced exercise-induced sensing complications with 4 leading to inappropriate shocks. After reprogramming in-line with screening, all but 1 patient have had no further issues.

Conclusions

Incorporation of exercise mapping into S-ICD screening protocols may improve vector selection to reduce inappropriate device therapies.
ICD patients with first appropriate ICD shock: new treatment concept is associated with better outcome
Authors: Kleemann T , Lampropoulou E , Kouraki K , Strauss M , Mohammad O , Wenz A , Zahn R
Published: May 2023

Funding Acknowledgements

Type of funding sources: None.

Introduction

Patients with implantable cardioverter defibrillator (ICD) receiving appropriate ICD-shocks are known to have a worse prognosis. We recently developed a new treatment concept for ICD-patients with appropriate ICD shock, the ToVAMI protocol consisting of the following three steps: Trigger optimization, Ventricular Arrhythmia treatment and Medical and Interventional prognostic heart failure treatment. This protocol was implemented into clinical practice since 9/2018. Aim of the study was to evaluate the impact of the ToVAMI protocol on the outcome of patients with first appropriate ICD shock.

Methods and Results

A total of 255 consecutive patients of a prospective single-centre ICD-registry who received a first appropriate ICD shock between 2012 and 8/2022 were analyzed. Patients with first ICD shock between 2012 and 8/2018 (control group, n = 175) were compared to patients with first ICD shock between 9/2018 and 6/2021 who were treated according to the ToVAMI protocol (ToVAMI group n = 80). Prospective use of the ToVAMI approach increased the rate of identified triggers (42% vs. 60%), VA therapy (34% vs. 51%), and tripled the rate of optimised heart failure treatment (Table 1). Patients treated according to the ToVAMI protocol had better survival without recurrent ICD shock (73% versus 55% at two years, p = 0.02) (Figure 1). The number of recurrent ICD shocks decreased from 48% to 25% after two years (p = 0.01), and all-cause mortality showed a trend towards lower mortality after two years (19% versus 10%, p = 0.32). In a multivariate analysis adjusting for 10 parameters, the ToVAMI approach was independently associated with a lower combined endpoint of mortality and repeated ICD shocks.

Conclusion

The use of ToVAMI in patients with first ICD shock is associated with a reduction of the combined endpoint of mortality and recurrence of appropriate ICD shocks.
Capsulectomy: a safe and effective way to lower shock impedance in S-ICD replacement procedures
Authors: Wuerfel S , Fastenrath F , Liebe V , Akin I , Borggrefe M , Duerschmied D , Kuschyk J , Rudic B
Published: May 2023

Funding Acknowledgements

Type of funding sources: None.

Background

The safety and efficacy of the subcutaneous implantable cardioverter-defibrillator (S-ICD) has been proven in various clinical trials. Due to intermuscular device placement, higher shock energy is required for effective treatment of ventricular tachyarrhythmia. High shock impedance is a risk marker for ineffective defibrillation. Previous studies have shown reduced shock efficacy in device replacement procedures, possibly due to fibrous encapsulation of the device associated with dwelling time of the system. Therefore, in case of significant capsulation, capsulectomy became part of device replacement procedure in our center. In this study we analyzed the results of intraoperative testing before and after capsulectomy measured by results of high-voltage impedance.

Purpose

Aim of our study was to show that removal of the fibrous capsulation can help to reduce high voltage impedance without relevant perioperative adverse events at the device replacement procedure.

Methods

Between January 2018 and November 2022, a total of 68 consecutive patients underwent S-ICD device replacement in our center. Pre-operative high-voltage impedance was determined either through recent therapy deliveries or by a 10J test shock immediately before device replacement. Device replacement was performed according to international standards. In case of significant capsulation, additional capsulectomy was performed. Defibrillation testing was routinely performed by the end of the procedure in the absence of contraindications.

Results

Of 68 patients, 81% were male, mean age at device replacement was 55 ± 17 years. Most patients were implanted for primary prevention (69%). Defibrillation testing with 65 J at initial device implantation was successful in 87% of patients. Mean dwelling time of the S-ICD System was 61 months (±19 months). Shock impedance increased significantly to 98±33 Ω vs. 80±20 Ω (p=0.013) at initial implantation. Capsulectomy of the S-ICD pocket resulted in a significant decrease of high-voltage impedance to 83±23 Ω as compared to measurement prior to replacement (p=0.03). Defibrillation testing was successful in all patients. First shock efficacy with 65 J was 92%. No acute complications (defined as significant bleeding, prolongation of hospital stay, etc.) were observed in short term follow-up and patients could be discharged as planned.

Conclusion

Capsulectomy of S-ICD pocket appears to be a safe and effective way to reduce shock impedance which has proven to be a predictor of successful defibrillation in testing as well as in spontaneous episodes. Despite the additional step during device replacement, no complications were observed in our study. Randomized trials regarding defibrillation testing during first implantation are ongoing. Trials addressing the optimal device replacement strategy however are warranted.
A 25-year single-center experience with transvenous and subcutaneous ICD patients under thirty years of age
Authors: Lewandowski M , Syska P
Published: May 2023

Funding Acknowledgements

Type of funding sources: None.

Background

Young implantable cardioverter-defibrillator (ICD) recipients present high rate of inappropriate shocks and complications. Some of them seem to be underestimated. The subcutaneous ICD(S-ICD) system was developed to eliminate lead-related complications and was proved to be effective, avoiding intracardiac and endovascular adhesions.

Aims To report on our clinical experience with transvenous (TV-ICD) and S-ICD therapy in patients under thirty years of age.

Methods

We reviewed database of ICD recipients in our institution between 1996 and 2022(25 years) and have chosen 125 pts consecutively implanted up to and including the age of 30 years. We retrospectively analyzed the rate of appropriate(AI) and inappropriate interventions(IS), lead complications rate, infection rate, mortality and treatment options.

Results

The study group: 84 TV-ICD(age: 6-30, BMI: 16,3-22,2) and 41 S-ICD( age: 15-30, BMI; 15,6-31,1) patients. The mean follow-up in analyzed groups was 159±48 and 40± 2 months respectively. Abnormal ventricular function: EF≤30 occurred in compared groups: 12/84(14%) and 5/41(12%) respectively, p=0,3. 24/84pts(28%) received ≥1 AI for VT/VF(ATP or shock) in TV-ICD and 4/40pts(10%) in S-ICD groups. 25/84 pts(30%) received one or multiple (IS) and 1/40pts(2,5%) in compared groups respectively, p=0,02. There were 18/84 (21.5%) ventricular lead dysfunctions(reimplantation of a new system) in TV-ICD and 0% in S-ICD groups, p=0,025. An infection rate (endocarditis or device pocket )was 8/84 (10%) in TV-ICD group with complete system removal and 1 pts (2,5%) wound infection(staphylococcus aureus) in S-ICD group successfully treated with antibiotics. 1 left ventricular assist device was implanted in end-stage heart failure S-ICD patient with good result. There were 2 S-ICD implantations as a concomitant device i.e. conversion of TV-ICD(with therapy OFF) to S-ICD due to ventricular lead dysfunction. 4(10%) pts required generator elective replacement due to early battery depletion in S-ICD group. In 2(5%)pts right sternal lead location was chosen due to better sensing results. Mortality rate was 6/84 pts (7%), caused by ventricular lead dysfunction, end-stage heart failure or heart transplantation fatal result in TV-ICD group. There was no death in S-ICD group.

Conclusions

TV- ICD implantation in children and young adults is a feasible and effective procedure in a 25-year follow-up but the rate of complications is high in this population. S-ICD recipients did not experienced lead failures or systematic infections. S-ICD appears to be a good therapy option and an alternative to TV-ICD in pediatric and young patients population, preventing from some serious lead complications and tricuspid valve regurgitation. The method and follow-up period effect is present between the TV-ICD and S-ICD in analyzed groups.
Trends in adoption of extravascular devices compared to conventional devices: real-world data from the Netherlands Heart Registration
Authors: Breeman K T N , Van Der Stoel M D , Van Dijk V F , Yap S C , Van Erven L , Maass A H , Boersma L V A , Wilde A A M , Knops R E , Tjong F V Y
Published: May 2023

Funding Acknowledgements

Type of funding sources: None.

Introduction

Extravascular devices (EVD), such as the subcutaneous ICD (S-ICD) and leadless pacemaker (LP), have been developed to circumvent pocket- and lead-related device complications. Knowledge on trends in adoption of these devices among patient categories and hospital types is mainly derived from industry-initiated studies or selected populations.

Purpose

To assess the real-world nationwide trends in adoption of EVDs in the Netherlands.

Methods

Using real-world data registered at the Netherlands Heart Registration from 72 Dutch device-implanting hospitals, all consecutive patients were included with an EVD implantation (de novo or replacement) from 2012-2020. To describe the relative adoption of EVDs, all consecutive patients with a single-chamber conventional ICD or pacemaker were also included (pacemakers from 2014, the first LP registration). Trends in EVD adoption are described for different patient (age, gender, and BMI) and hospital (tertiles of device-implanting volume and implanting center [general , intervention, or thorax]) characteristics. Differences in adoption were tested using Chi-square and Fisher’s exact tests.

Results

From 2012-2020, 2862 S-ICDs and 15806 single-chamber conventional ICDs were implanted, while from 2014-2020, 785 LPs and 16530 single-chamber conventional pacemakers were implanted. S-ICD use among single-chamber ICD recipients increased from 7% to 22% and LP use among single-chamber pacemaker recipients increased from 1% to 8%, although utilization has levelled off in recent years (Fig. 1). The relative use of S-ICDs was largest in patients aged 10-30 years and declined with higher age (p<0.001); LP use ranged between 0 and 6% among age groups, with no specific preference at older age (p=0.002)(Fig. 2A). S-ICDs were used more in female than male ICD recipients (p=0.005); LPs more in male than female pacemaker recipients (p=0.002)(Fig. 2B). EVD utilization was largest in patients with a BMI <25 kg/m2 (S-ICDs p<0.001; LPs p=0.02)(Fig. 2C). EVDs were mostly implanted in high-volume centers (S-ICDs p=0.03; LPs p<0.001). S-ICDs were implanted mostly in thorax centers (p<0.001); LPs in thorax centers only.

Conclusions

Although EVDs have been adopted early in the Netherlands, their utilization has levelled off in recent years, possibly driven by higher cost, battery issues, or the COVID-19 pandemic. Utilization of S-ICDs is highest among younger patients while utilization of LPs was not specifically high in certain age groups. The effects of gender and BMI were smaller. EVDs were mainly implanted in high-volume thorax centers.
Stepwise application of ECG and electrogram based criteria to ensure left bundle branch pacing
Authors: Pujol-Lopez M , Ferro E , Borras R , Garre P , Guasch E , Niebla M , Carro E , Roca-Luque I , Guichard J B , Uribe L , Arbelo E , Porta-Sanchez A , Sitges M , Tolosana J M , Mont L
Published: May 2023

Funding Acknowledgements

Type of funding sources: Public Institution(s). Main funding source(s): MPL received the Catalan Society of Cardiology Research Grant in 2019 and 2020 (Catalonia, Spain); the Josep Font Grant (2019-2022) from Hospital Clínic Barcelona (Catalonia, Spain).

Background

Left bundle branch pacing (LBBP) has emerged as an alternative to biventricular pacing. However, lack of a systematic stepwise application of the left bundle branch (LBB) capture criteria complicates implantation.

Objective

To define a stepwise application of LBBP capture criteria that will simplify implantation and ensure LBB capture.

Methods

A cohort of 24 patients from the LEVEL-AT trial who received LBBP and had electrocardiographic imaging (ECGI) at 45 days post-implant were included. The usefulness of ECG and electrogram based criteria to predict accurate LBB capture were analyzed. A two-step approach was developed to ensure LBB capture. The gold standard used to confirm LBB capture was the change in ventricular activation pattern and shortening in left ventricular activation time, assessed by ECGI.

Results

Twenty-two (91.6%) patients showed LBBP capture on ECGI. All patients fulfilled pre-screwing requisites: lead in septal position in left-oblique projection and W paced morphology in V1. In the first step, presence of either right bundle branch conduction delay pattern (qR or rSR in V1) or left bundle branch capture Plus (QRS ≤120ms) resulted in 95% sensitivity and 100% specificity to predict LBB capture, with an accuracy of 95.8%. In the second step, the presence of selective capture (100% specificity, only 41% sensitivity) or a spike-R<80ms (100% specificity, sensitivity 46%) ensured 100% accuracy to predict LBBP capture.

Conclusions

Stepwise application of ECG and electrogram criteria ensured an accurate assessment of left conduction system capture.
Left ventricular global strain and duration of QRS complex as predictors of prognosis after cardiac resynchronization therapy
Authors: Mashal A , Soltan G , Samy N , Soliman A
Published: May 2023

Funding Acknowledgements

Type of funding sources: Public Institution(s). Main funding source(s): National heart institute and Menoufia university, Egypt.

Background

cardiac resynchronization therapy is effective for patients with chronic heart failure with reduced left ventricular ejection fraction and wide QRS (≥120 ms). We aimed to verify that a baseline left ventricular global longitudinal strain(LVGLS) and qrs duration may be beneficial as predictors of prognosis of CRT response.

purpose

We aimed to evaluate if LVGLS & QRS duration may be of additive prognostic value in CRT response.

Methods

Transthoracic echocardiography was performed prior to and 6 months after CRT implantation. Echocardiography was performed to assess left ventricular function as LVGLS. The response to CRT was defined as improvement in NYHA functional class (at least one class) and ≥ 15% reduction in the left ventricular end-systolic volume or improvement in left ventricular ejection fraction > 10. Comparison between responders and not responders was done using the appropriate test, and ROC analyses were done for QRS duration and LVGLS to predict CRT response.

Results

fifty-five HF patients (age 58 ±8 years, LVEF 23 ±5%, QRS duration 159 ±8ms, 30.9% ischemic aetiology of HF) underwent CRT implantation. The percentage of responders was 72.72% (Table). Baseline LVGLS differed significantly according to CRT response (P < 0.019). The best cutoff for LVGLS to predict response was 6.2, at which sensitivity and specificity were 70% and 73.3%, respectively with AUC of 0.793, with a 95% confidence interval (CI) of 0.651 - 0.936 (P = 0.001). Also, there was a statistically significant difference of the baseline QRS duration between the patients who had and hadn’t CRT response (P <0.001). The best cutoff was >154 ms,at which sensitivity and specificity were 87.5% and 86.7%, respectively. (AUC was of 0.793, with a 95% CI ranging from 0.651 - 0.936 (P = 0.001).

Conclusion

Baseline LVGLS and QRS duration may have a prognostic value in prediction CRT response. Baseline LVGLS (>6.2) and QRS duration (>154ms) may help to select CRT responders.
Left-bundle branch block, an alert for cardiac resynchronization therapy
Authors: Gatti P , Kristjansdottir I , Azari A , Anselmino M , Lind S , Savarese G , Linde C , Gadler F
Published: May 2023

Funding Acknowledgements

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

Background

Left bundle branch block (LBBB) might be the first finding of cardiovascular diseases but it is also the target of cardiac resynchronization therapy (CRT) in heart failure (HF) with reduced ejection fraction (HFrEF). LBBB prognosis and the implication of CRT in an unselected real-world setting are of great potential clinical impact.

Methods

A central ECG database together with national registries has been screened to identify LBBB patients. Cox models were fitted to assess the hazard ratio (HR) of death, cardiovascular death (CVD) and HF hospitalization (HFH) according to gender and CRT use. A subdistribution of the hazard ratio (SHR) was used to account for non-cardiovascular death as a competing risk. Logistic regression was fitted to investigate characteristics associated with CRT use.

Results

Of 5359 patients with LBBB and QRS duration over 150ms, 36% were female. The median age was 76 years and males had a significantly higher risk of death after 5 years from the LBBB diagnosis. CRT, when indicated, has a large benefit on all-causes of death (HR: 0.53, 95% confidence intervals (CI): 0.42-0.67), CVD (HR: 0.53 CI: 0.39-0.71) and HFH (HR: 0.71 CI: 0.60-0.82), especially in the first 5 years after the indication. These results are consistent with the competing risk analysis.

Conclusion

In an unselected LBBB population, CRT is underused but extremely beneficial. Therefore it’s crucial to find ways of better implementing and understanding CRT utilization, focusing on characteristics that influence recommendations.
Long term conservation of electrical synchrony by multipoint pacing with dynamic atrioventricular delays
Authors: Thibault B , Chow A , Mangual J , Badie N , Waddingham P , Mcspadden L , Betts T , Calo L , Leyva F
Published: May 2023

Funding Acknowledgements

Type of funding sources: Private company. Main funding source(s): Abbott.

Introduction

Automatic adjustment of atrioventricular delay (AVD) with SyncAV has been shown to improve electrical synchronization. However, the long term effects of SyncAV optimization on electrical synchrony are unknown.

Purpose

Evaluate the effect of SyncAV programming on 6-month (6mo) QRS duration during biventricular (BiV) and left ventricle only MultiPoint Pacing (MPP).

Methods

Patients with LBBB and QRS duration (QRSd) ≥ 150 ms scheduled for CRT-P/D device implantation with quadripolar LV lead were enrolled in this prospective study. QRSd was measured post-implant from 12-lead surface ECG by blinded experts during the following pacing modes: intrinsic conduction, MPP (MPP=RV+LV1+LV2) and LV-only MPP (LVMPP=LV1+LV2). For each mode, SyncAV was enabled (e.g. MPP+SyncAV) with the patient-tailored SyncAV offset that minimized QRSd. Patients were then randomized 1:1 to receive MPP+SyncAV or LVMPP+SyncAV with the optimal offset identified at implant, and QRSd was re-evaluated at the 6mo follow-up.

Results

Fifty-nine patients (72% male, 41% ischemic, 26% ejection fraction, 166 ms intrinsic QRSd) completed device implant and QRSd assessment. Relative to intrinsic conduction at implant, the MPP+SyncAV group (n=30) had a QRSd reduction of 26% at implant (162 to 122 ms, p<0.001), and 20% at 6mo (162 to 130 ms, p<0.001). The LVMPP+SyncAV group (n=29) had a QRSd reduction of 24% at implant (165 to 128 ms, p<0.001), and 15% at 6mo (165 to 140 ms, p<0.001). In the MPP+SyncAV group, 28/30 (93%) of patients had more than 10% reduction in QRSd with respect to intrinsic at implant, with 27/30 (90%) maintaining this trend at 6 mo follow up. With LVMPP+SyncAV pacing, only 25/29 (86%) of patients had more than 10% reduction in QRSd with respect to intrinsic at implant, and this reduced to 18/29 (62%) maintaining this trend at 6 mo follow up.

Conclusion

MPP combined with SyncAV significantly improved acute electrical synchrony at implant in CRT patients with LBBB, as assessed by QRSd reduction. Significant QRSd reduction was maintained at 6 months post-implant by both biventricular and LV-only MPP configurations.
What determines who gets cardiac resynchronization therapy in europe?
Authors: Gatti P , Thorvaldsen T , Benson L , Normand C , Savarese G , Dahlstrom U , Maggioni A , Lund L H , Linde C , Dickstein K
Published: May 2023

Funding Acknowledgements

Type of funding sources: Foundation. Main funding source(s): Supported by Swedish Heart and Lung foundation and Stockholm County Council.

Background/Introduction

Cardiac resynchronization therapy (CRT) is a valuable treatment in selected patients with heart failure (HF) but is still underutilized.

Aim

We compared three informative data sources, which enrolled patients with HF at different organization setting and identified clinical, organizational, and level of care factors linked to CRT implantation in these cohorts.

Methods

Data from three large cohorts of patients with HF were compared. Patients with HF with reduced ejection fraction (HFrEF) in an ESC HF-Long Term Registry (ESC-HF-LT, n=25,621), a National HF Registry - Swede HF (n=156,621) and in the ESC-CRT Survey II (n=11088, all receiving CRT across 42 ESC countries), contributed data to the analysis. The ESC Survey II recruited patients at implanting centers, ESC-HF-LT at HF centers, whereas SwedeHF enrolled HF patients at different levels of care. Firstly, we compared patient characteristics, socio-economic and organizational factors between cohorts as well as between overlapping countries participating both in CRT Survey II and ESC HF LT. Secondly, we identified independent predictors of CRT use in the two registries using multivariable logistic regressions.

Results

Of the 1031 patients in ESC-HF-LT and the 5008 patients in Swede-HF, CRT was not used in 53-75 % of guideline- indicated patients. Women constituted 22% and median age ranged between 68-72 years. Guideline Directed Medical Therapy (GDMT), atrial fibrillation, previous myocardial infarction (SwedeHF) and HF hospitalization (ESC-HF-LT) was associated with more CRT use as was enrollment at university hospital and follow-up at HF center/Hospital. In Swede-HF above median income and higher education level were also independently associated with use of CRT. In the ESC-CRT Survey II (n=11.088) all patients received CRT with differences in the clinical indications between countries.

Conclusion(s)

CRT is an important treatment option for eligible patients with HF, which is still largely underused. The findings reported demonstrate that awareness of CRT indications as well as demographics, organizational and economic factors play an important role in CRT utilization.
Correction of dyssynchrony by conduction system pacing: results of LEVEL-AT trial
Authors: Pujol-Lopez M , Garcia-Ribas C , Jimenez-Arjona R , Borras R , Garre P , Guasch E , Ferro E , Niebla M , Guichard J B , Porta-Sanchez A , Roca-Luque I , Sitges M , Tolosana J M , Doltra A , Mont L
Published: May 2023

Funding Acknowledgements

Type of funding sources: Public Institution(s). Main funding source(s): Catalan Society of Cardiology; Asociación del Ritmo Cardiaco (Spanish Society of Cardiology).

Background

Correction of dyssynchrony measured with echo strain, in conduction system pacing (CSP) vs biventricular pacing (BIVP) has not been reported.

Objectives

Our purpose was to compare echocardiographic dyssynchrony correction and strain improvement during follow-up between CSP and BIVP.

Methods

A treatment received analysis was performed in patients (n=29 CSP; BIVP 40). Patients were evaluated at baseline (ON and OFF programming) and at 6 and 12 months. All echocardiograms were completed by operators blinded to the type of device implanted. Intraventricular (septal flash), interventricular (difference between left and right ventricular outflow times), and auriculoventricular (diastolic filling time) dyssynchrony, as well as strain parameters (septal rebound, global longitudinal strain (GLS), and Risum pattern (typical left bundle branch block contraction pattern)) were analyzed.

Results

32% (22/69) were women; baseline LVEF was 27.5% (7% SD) and left ventricular end-systolic volume (LVESV) 138ml (77ml SD) without differences between groups. At the 12-month follow-up, there were no differences in CSP vs. BIVP in LVEF (45.8% (10% SD) vs. 42.7% (12% SD), p=0.25) and LVESV (81.5 ml (41 ml SD) vs. 101.7 ml (56 ml SD), p=0.08).

Longitudinal analyses showed that the improvement of all echocardiographic dyssynchrony parameters over time was similar between groups (p<0.001) (Table 1 and Fig 1A). GLS acute correction significantly correlated with LVEF and LVESV at the 12-month follow-up (Fig 1B).

Conclusions

CSP and BIVP provided a similar dyssynchrony and strain correction over time. Acute strain correction predicted ventricular remodeling at 12 months follow-up.
Long-term outcome in patients with heart failure and diabetes mellitus treated with cardiac resynchronization therapy
Authors: Jedrzejczyk-Patej E , Mazurek M , Kotalczyk A , Gumprecht J , Lenarczyk R , Sokal A , Pruszkowska P , Szulik M , Kowalski O , Sredniawa B , Kalarus Z
Published: May 2023

Funding Acknowledgements

Type of funding sources: None.

Background

Cardiac resynchronization therapy (CRT) is a proven therapy in patients with heart failure (HF) with reduced left ventricular ejection fraction (LVEF). However, little is known about the long-term prognosis and the risk of cardiac device-related infective endocarditis (CDRIE) in patients with HF and diabetes mellitus (DM) treated with CRT.

Aim

To assess the long-term outcomes, mortality predictors, and the risk of CDRIE in patients with HF and DM undergoing CRT.

Methods

Study population consisted of 1059 consecutive patients with CRT implanted between 2002 and 2019 in a tertiary care university hospital in a densely inhabited, urban region of Poland (949 subjects [89.6%] with CRT-D; 110 patients with CRT-P [10.4%]; 832 men [78.6%]). Population was divided into DM and control group (without DM); n=367 (34.7%) vs. n=692 (65.3%), respectively.

Results

During the median follow-up of 1661 days (10th and 90th percentile: 323-3995), all-cause mortality in DM group was significantly higher than in control group (61.9% vs. 50.3%, P=0.0003; Figure 1). The risk of CDRIE was 6.5% vs. 4.9% respectively in both groups (P=0.27). On multivariable regression analysis, older age (HR 1.03, 95%CI 1.01-1.05, P<0.001), ischemic cardiomyopathy (HR 1.60, 95%CI 1.18-2.19, P=0.003), lower left ventricular ejection fraction (HR 0.96, 95%CI 0.94-0.99, P=0.002), higher creatinine level (HR 1.004, 95%CI 1.001-1.006, P=0.001), and diabetes treated with insulin (HR 1.56, 95%CI 1.19-2.05, P=0.001) were identified as independent predictors of higher mortality in patients with DM undergoing CRT impantation.

Conclusions

Compared with patients without diabetes, mortality rates of those with DM treated with CRT implantation are significantly higher and nearly 2/3 of patients die within 4.5 years. Advanced age, ischemic cardiomyopathy, lower left ventricular ejection fraction, higher creatinine level, and diabetes treated with insulin are independent mortality predictors in subjects with HF and DM treated with cardiac resynchronization therapy.

Figure 1. Kaplan-Meier curves for survival of patients with and without diabetes mellitus (DM) treated with cardiac resynchronization therapy (log rank P<0.001)
Cardiac resynchronization therapy guided by activation mapping in non-left bundle branch block patients
Authors: Quesada Ocete F J , Vallejo Yuste A , Rojas Escriva B , Quesada Ocete B , Cervero Rubio A , Jimenez Bello J , Palanca Gil V , Luengo Perez S , Llopis Gisbert G , Perez Bosca J L , Cubillos Arango A , Moruno Benita M A , Gradoli Palmero J , Paya Serrano R , Quesada Dorador A
Published: May 2023

Funding Acknowledgements

Type of funding sources: None.

Introduction

Various studies have questioned the magnitude of the benefit of cardiac resynchronization therapy (CRT) in patients without left bundle branch block (LBBB). This worse response could be due to the suboptimal location of the electrodes.

Purpose

We hypothesize that in non-LBBB patients, an implant guided by ventricular electroanatomic mapping by locating the areas with the greatest activation delay will improve the outcome of CRT.

Material and methods

We included 7 patients non-LBBB. To locate the most delayed activation zones, an electromagnetic activation map was created using the Ensite Precision navigator connected to the right ventricular catheter and to a guidewire with electrical recording capacity at its distal end. ECG, clinical, and echocardiographic data were recorded at baseline and post-implantation, compared with 7 patients LBBB (control group).

Results

In non-LBBB patients, several activation patterns could be defined according to the conduction disorder, including right bundle branch block (RBBB)+left anterior hemiblock (figure 1A) or RBBB alone (figure 1B). All patients with non-LBBB improved at follow-up in the NYHA functional class (p=0,011) and in the Minnesota test (7,85±4,63; p=0.004). The mean reduction in QRS duration was 14,57±9,86 ms (p=0.008), LVEF increased 8.22±4.62 ms (p=0.003), LVOTS decreased by 15,71±12,23 ml (p=0.015) and the LVEDV in 10,42±5,15 ml (p=0.002). There were no significant differences between the response to CTR in non-LBBB patients and LBBB patients (table 1), including LVEF (8.22±4.62 vs 11.54±5.54, p=0.248) and difference in Minnesota test (7.85±4.63 vs 9.71±5.87, p=0.524).

Conclusions

CRT guided by electroanatomical mapping produced significant clinical and structural improvement in non-LBBB patients. This improvement was of a similar magnitude to LBBB patients. Various patterns of ventricular activation according to the conduction disorder were observed.
Changes in myocardial perfusion according to left ventricular pacing site in cardiac resynchronization therapy
Authors: Stephansen C , Sommer A , Kronborg M , Jensen J M , Noergaard B L , Gerdes C , Kristensen J , Jensen H K , Fyenbo D , Tolbod L P , Bouchelouche K , Nielsen J C
Published: May 2023

Funding Acknowledgements

Type of funding sources: Foundation. Main funding source(s): 1. The Danish Heart Foundation

2. The Health Research Fund of the Central Denmark Region

Background/Introduction

Changes in left ventricular (LV) myocardial perfusion according to LV pacing site during cardiac resynchronization therapy (CRT) has only been sparsely described.

Purpose

To assess changes in LV global and regional myocardial perfusion according to LV pacing site after six months CRT.

Methods

Data from patients enrolled in the randomized controlled trial "Electrically vs. Imaging-guided Left Ventricular Lead Placement in Cardiac Resynchronization Therapy" was evaluated.

Global and segmental absolute myocardial perfusion in ml/g/min was assessed by 82Rb-PET the day before CRT implantation and at six-months follow-up (6MFU). The exact LV pacing site was determined by post-implant cardiac CT. Perfusion and pacing site were evaluated using the standard 17’-segment LV model. Echocardiographic assessment of LV ejection fraction (EF) was performed the day before CRT implantation and at 6MFU.

Results

93 patients (age 71±9 years; ischemic heart disease 48%; female 25%; median QRS 166±20 ms; mean LVEF 30±7%; NYHA class I/II/III/IV (%) 0/63/33/3) were included.

Distribution of LV pacing sites is shown in Figure 1.

No change in LV global perfusion was observed from baseline to 6MFU (0.79 to 0.81 ml/g/min, P=0.41; respectively).

LV EF increased by 9±10%. Baseline global perfusion was higher in the 39 patients in whom LV EF had increased ≥10% at 6MFU (0.86 vs. 0.74 ml/g/min, P=0.02; respectively). However, no difference in perfusion-change was observed between patients with ≥10% increase in LV EF at 6MFU and patients with <10% increase (0.01 vs. 0.02 ml/g/min, P=0.76; respectively).

Baseline perfusion was higher in the segments chosen for LV-pacing than in the non-paced segments (0.96 vs. 0.78 ml/g/min, P=0.00; respectively). Perfusion in the paced segments dropped to 0.86 ml/g/min (P=0.00) at 6MFU. Perfusion in the neighbouring segments also dropped during six months (from 0.91 to 0.86 ml/g/min, P=0.03), while perfusion in the non-paced and non-neighbouring segments increased (from 0.75 to 0.80 ml/g/min, P=0.01).

Conclusion

Despite a mean increase in LV EF of 9%, global myocardial perfusion remained unchanged. CRT resulted in a homogenous distribution of myocardial perfusion with a decreased perfusion in segments concordant and adjacent to LV pacing site and a corresponding increased perfusion in remote segments.
The effect of Remote Monitor vs Standard of Care therapy on outcome A systematic review and meta-analysis
Authors: Veres B , Kiss B , Fehervari P , Engh M , Kuthi L , Schwertner W , Behon A , Richard M , Merkel E D , Hegyi P , Zima E , Merkely B , Kosztin A
Published: May 2023

Funding Acknowledgements

Type of funding sources: Public grant(s) – EU funding. Main funding source(s): Project no. RRF-2.3.1-21-2022-00004 (MILAB) has been implemented with the support provided by the European Union.

Background

Remote monitoring (RM) in heart failure (HF) patients with cardiac implantable electronic devices (CIED) is a reliable approach to strictly following the device-specific and heart failure-related parameters. Despite a few positive outcome data, results are incomprehensive.

Aims

We aimed to assess the benefit of continuous RM vs. standard of care (SoC) in the reduction of all-cause mortality, heart failure hospitalization (HF), and cardiovascular-related hospitalization (CV), and inappropriate therapy.

Methods

A systematic review and meta-analysis of randomized controlled trials (RCT) testing RM vs. SoC for the management of HF patients were performed. Endpoints were all-cause mortality, CV- and HF hospitalizations and inappropriate therapy. Odds ratios (ORs) and 95% confidence intervals (CI) were calculated. CENTRAL, EMBASE and MEDLINE were searched up to 21th of December 2021. Only randomized controlled studies were included.

Results

Fourteen RCTs that enrolled a total of 8370 patients were identified to evaluate all-cause mortality, resulting in an OR 0.88 (95% CI 0.75 to 1.03). When CV - and HF hospitalizations were assessed, there were no differences between the RM group and SoC group, and the OR was 0.93 (95% CI 0.82 to 1.05) and 0.95 (95% CI 0.75 to 1.19), respectively.Moreover RM did not have an effect on the rate of inappropriate therapy, OR was 0.73. (95% CI 0.30 to 1.81).

Conclusions

RM proved to be non-inferior in reducing all-cause mortality, CV- and HF hospitalization and rate of inappropriate therapy when compared to standard of care despite of the heterogeneous study cohorts and unstandardized alert actions.
Predictive value of scar burden assessed by cardiac MRI on sudden cardiac death in cardiac resynchronization therapy patients: a systematic review and meta-analysis
Authors: Masszi R , Turan C , Sayour A , Zsigmond E , Hegyi P , Fehervari P , Kosztin A , Merkely B
Published: May 2023

Funding Acknowledgements

Type of funding sources: Public grant(s) – National budget only. Main funding source(s): Ministry of Innovation and the National Research, project no. RRF-2.3.1-21-2022-00003 and Project no. RRF-2.3.1-21-2022-00004 (MILAB) has been implemented with the support provided by the European Union.

Background

Myocardial fibrosis (MF) is associated with a higher prevalence of ventricular arrhythmias (VA) and sudden cardiac death (SCD). Late gadolinium enhancement cardiovascular magnetic resonance (LGE-CMR) can accurately evaluate the extent of MF. Clinical evidence suggests that scar assessment may help the decision of adding an implantable cardioverter defibrillator (ICD) to cardiac resynchronization therapy (CRT) to reduce the risk of VA and SCD.

Purpose

In this systematic review and meta-analysis, we collected and analyzed evidence pertaining to the association between scar burden and the risk of VA and SCD, and we evaluated the impact of appropriate device choice for CRT.

Methods

We performed a systematic literature search on MEDLINE using the PubMed, Embase, Scopus and CENTRAL databases. The target population were adults with heart failure with reduced ejection fraction who underwent CRT. The primary outcome was the association between the incidence of VA and/or SCD and scar burden assessment. Meta-analyses were performed using the META and DMETAR packages in R, using a random-effects model. The risk of bias was assessed using RoB2and the quality of evidence was evaluated using the GRADE assessment.

Results

6 eligible articles have been included in our study, with a total of 1548 patients, of whom 465, 696, and 387 have been implanted with an ICD, CRT-D, CRT-P respectively. Altogether 62,68 % of the total population were LGE-CMR positive. The proportion of appropriate ICD shock reached 15,65 % in the total population during the median follow-up time of 51,59 months. The risk of developing appropriate ICD shocks in the LGE positive population was almost 70% higher (Hazard ratio 1,69, 95% Confidence interval: 1,29- 2,21; p<0,001) compared to LGE negative patients.

Conclusion

In our meta-analysis, LGE-CMR was significantly associated with appropriate device therapy and can identify a subgroup of patients with an increased risk of life-threatening VA. Based on our results performing an MRI before device implantation might be important to select the high-risk patients for SCD in the elderly with ischaemic etiology and older age.
Combination of device-detected heart failure status and sleep-disordered breathing for the prediction of atrial fibrillation occurrence
Authors: Vitali F , Bertini M , D'onofrio A , Vitulano G , Calo' L , Savarese G , Santobuono V E , Dello Russo A , Mattera A , Santoro A , Calvanese R , Arena G , Valsecchi S , Mazza A , Boriani G
Published: May 2023

Funding Acknowledgements

Type of funding sources: None.

Aims

Patients with atrial fibrillation (AF) frequently experience sleep disorder breathing, and both conditions are highly prevalent in presence of heart failure (HF). We explored the association between sleep apnea (SA) and the HF status and the incidence of AF in patients with implantable defibrillators (ICD).

Methods

Data were prospectively collected from 411 consecutive HF patients with ICD. The HF status was measured by the multisensor HeartLogic Index, and the ICD-measured Respiratory Disturbance Index (RDI) was computed to identify severe SA. The endpoints were: daily AF burden of ≥5minutes, ≥6hours and ≥23hours.

Results

During a median follow-up of 26 months, the time IN-alert HF state was 13% of the total observation period, according to the HeartLogic algorithm (Index >16). The RDI value was ≥30 episodes/h (severe SA) during 58% of the observation period. An AF burden of ≥5 minutes/day was documented in 139 (34%) patients, ≥6 hours/day in 89 (22%) patients, and ≥23 hours/day in 68 (17%) patients. The IN-alert HF state was independently associated with AF regardless of the daily burden threshold: hazard ratios from 2.17 for ≥5 min/day to 3.43 for ≥23 h/day (p<0.01). The occurrence of severe SA was associated only with AF burden ≥5 min/day (hazard ratio 1.55 [95%CI:1.11-2.16], p=0.001). The combination of HF alert and severe SA accounted for only 6% of the follow-up period and was associated with high rates of AF occurrence (from 28 events/100 patient-years for AF burden≥5 min/day to 22 events/100 patient-years for AF burden≥23 h/day).

Conclusions

In patients with heart failure (HF) and implantable defibrillators (ICD), the occurrence of atrial fibrillation (AF) was independently associated with the worsened HF status measured by a multisensor ICD algorithm and with ICD-diagnosed severe sleep apnea (SA). The HF status was independently associated with AF regardless of the daily burden, while severe SA was mainly associated with shorter AF episodes. The coexistence of these two conditions occurs rarely but is associated with a very high rate of AF occurrence.
Novelty about pocket histology at cardiac implantable electronic device reopening procedures
Authors: Massaro G , Leone O , Valzania C , Angeletti A , Corti B , Martignani C , Diemberger I , Baldovini C , Ziacchi M , Biffi M
Published: May 2023

Funding Acknowledgements

Type of funding sources: None.

Background

Cardiac implantable electronic device (CIED) procedures, characterized by reopening of the CIED pocket, increase infectious risk. In particular, pocket adhesions’ debridement may prolong procedure time, increasing the infectious risk. Nowadays, only few data are available on pocket histology at CIED reopening procedures.

Purpose

The aim of this study was to describe CIED pocket histology in a cohort of patients undergoing CIED replacement or upgrade.

Methods

All patients undergoing CIED replacement or upgrade at our center between November 2019 and May 2020 were enrolled. Subclinical pocket infection was ruled out by physical inspection and laboratory parameters. Pocket tissue specimens from anterior and posterior pocket wall were obtained. A systematic histological analysis of capsular thickness, fibrotic tissue, neovascularization, inflammation, and calcifications was performed.

Results

30 patients (80% male) were enrolled. Mean capsular thickness of anterior and posterior wall was 0.8±0.3 mm and 1.1±0.4 mm, respectively. Subcapsular fibrosis was mild and multifocal in the anterior wall, and moderate and focal in the posterior. Neovascularization was mainly focal, and in most cases vessel remodelling involved the tunica media. Chronic inflammation was usually mild and non-granulomatous, and in a quarter of cases subacute exudative inflammation was detected in the posterior pocket wall.

Conclusion

CIED pocket is an histopathologically dynamic environment, characterized by the coexistence of a subacute foreign body response and a fibrous tissue growth, that produces a continuous remodelling due to injury-repair mechanisms. Strategies to reduce foreign body response might minimize inflammatory pocket activity, especially device encapsulation by fibrotic tissue, and simplify CIED reopening procedures. This can impact on CIED replacement or upgrade complications and infectious risk.