bluuebunny/crossref_metadata_2025 huggingface dataset:
Changes in the implantation procedures of pacemakers during the COVID-19 pandemic in Germany
Authors: Schwab JO , Wiese J , Hauser T
Published: May 2022

Funding Acknowledgements

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

Background

During the beginning of the first pandemic wave beginning in spring 2020 a lot of elective EP procedures were set on hold. After a few months, the hospitals were allowed to proceed with their planned operations. The current investigation analyzed the changes in the number of cardiac pacemakers (PM) implantations in whole Germany.

Methods

We performed a data retrieval of the number of monthly first-time pacemaker implantations, i.e. single-, dual-chamber, or CRT-P, for the 2019 pre- and 2020 pandemic from the "Institut für das Entgeltsystem im Krankenhaus" (InEK) using OPS codes. This database provides data of all in-hospital procedures in Germany.

Results

The course of the implantation rates (January to September) is highlighted in the two figures, where figure 1 demonstrates the single- and dual-chamber PM, and figure 2 the CRT-P implantations in 2019 (blue line) compared to 2020 (red line). It can be clearly seen, that for the single- and dual-chamber PM, a gap occurs between March and Mai in 2020. On the contrary, for the sicker patients, who are in the need for CRT-P, the lines do no cross, significantly. Moreover, the number of CRT-P first-time implantations increased during May to September 2020.

Discussion

The present study highlights the course of first-time pacemaker implantations throughout the beginning of the COVID-19 pandemic in whole Germany. In contrast to single- and dual-chamber PM implantation rates, the number of CRT-P implantations remained stable during the first three months of the pandemic and then exceeded the rates from 2019. The progressive nature of heart failure resulting in the need for CRT may be one reason for not postponing the first-time implantation in the months March to May 2020.
Left Bundle Branch Pacing: procedural outcomes using different sheaths
Authors: Marcantoni L , Centioni M , Pastore G , Manzato E , Fornasaro M , Cappato E , Pigaiani C , Marsiglia S , Baracca E , Zanon F
Published: May 2022

Funding Acknowledgements

Type of funding sources: None.

Background

Left Bundle Branch Pacing (LBBP) ensures physiologic ventricular activation. Growing experiences are rising on its applicability . Different tools available allow successful implant in different cardiac anatomies.

Objective

To analyse implant success rate and acute electrical parameters in LBBP guided by C315 fixed curve sheath or Selectra3D sheath.

Methods

151 patients (mean age 79.8±8.3 years; 51% males) received LBBP. Pacing indication: AV block 50%, SND 12%, slow AF12%, ablate&pace 9%; HF 14%, revision of previous lead 1%. Coronary disease was present in 31%; hypertension in 93%, diabetes in 30%, severe valvular disease in 5%, persistent AF in 31% pts. Average QRS duration was 136±34 ms. Basal mean EF 52±12%. Different criteria for successful LBBP were analyzed (table 1).

Results

The lead was successfully implanted in the left bundle in 97.3% pts. In 60.5% pts guided by the C315 Medtronic fixed curve sheath while in 39.5% pts by the Selectra3D (40-S, 55-M, 65-L) Biotronik sheaths. 93 (63%) pts received 3830 fixed screw lead, 51 (35%) pts received Solia S 60 stylet-driven lead and 3 (2%) patients received Tendril 58 cm stylet-driven lead. All different criteria analysed to define successful LBBP were comparable in the C315 and Selectra 3D group (table 1). In 61% pts LBBP was the first choice, in 39% LBBP was aimed after unsatisfactory HBP (His threshold>2V or paced QRS>140 ms). The LBBP lead was connected to the RV port in 67% DR and 18% SR PMs; to the LV port in the 22 CRT devices. Mean fluoroscopy time was 10±6 min including implant of all leads, without differences between implants. Electrical parameters were highly favourable in all patients (mean threshold 0.73±0.27V and mean sensing 11±5.8 mV) without differences between the 2 sheaths. Pacing impedance was significantly lower in the Selectra 3D group. Paced QRS duration was 114±15 ms (112±14 vs 116±16 ms; P 0.180). Implant failure were 4 (2 due to severe tricuspid regurgitation and 2 to severe dilated atria).

Conclusion

LBBP is highly reliable in clinical practice. The different sheath available lead to successfully perform the implant in different cardiac anatomies. In our experience there was no differences in technical acute outcome between implant guided by C315 Medtronic sheath and Selectra3D Biotronik sheath.
Conduction system pacing with Selectra 3D Sheath: Technical Results
Authors: Marcantoni L , Centioni M , Pastore G , Baracca E , Marsiglia S , Fornasaro M , Pigaiani C , Cappato E , Manzato E , Zanon F
Published: May 2022

Funding Acknowledgements

Type of funding sources: None.

Background

Conduction system pacing (CSP) allows physiological electrical activation. The Selectra3D sheath is a new tool able to guide the lead implantation on the His Bundle (HBP) or on the left bundle branch (LBBP). It does exist in 3 different shapes (40-S, 55-M, 65-L).

Objective

To evaluate the effectiveness of different Selectra3D introducers for CSP, considering the procedural success, stability of electrical parameters or need for implant revision at medium-term follow-up.

Methods and results

Selectra3D was used in 113 CSP procedures between Nov 2019 and Nov 2021. Mean patients age was 80±6 years, 54% males. Pacing indications were: AV block 52.2%, slow AF 12.4%; SND 12.4%, ablate&pace 5.3%, implant revision 0.9%, cardiomyopathy 16.8%. Mean EF was 40±15%. Single chamber PM was implanted in 4.8% pts, dual chamber PM in 57.1% pts while 26.2% and 11.9% pts received CRT-P and CRT-D devices respectively. Stylet-driven lead was used in 75 pts, fixed screw lead in 38 pts. HBP was obtained in 34% pts, LBBP in 55% pts, HBP+LBBP in 3% pts, while 8% cases were CSP implant failure (7 lead implanted in the septum; 2 in the coronary sinus). Selectra3D was the first delivery used during the procedure in 88% of cases (55-M in 76%; 40-S in 9%; 65-L in 3%), while was the second tool (after failure of the first delivery utilised) in the other pts. The first Selectra3D utilized during each implant was able to complete the procedure in 64% of cases, while in the other pts a second different tool was required to complete the implant. The Selectra3D 55-M was the mostly used and was able to reach the final position in most cases. In dilated atria the 65-L curve was preferred, while when the target point was more proximal the 45-S curve was the best choice. The baseline QRS duration was 135 ± 34 ms and the paced QRS duration was 113 ± 18 ms (P 0.003). The electrical parameters were optimal with sensing 8.7 ± 8 mV; impedance 562 ± 133 ohm; threshold 0.97 ± 0.47 V. During a median follow-up of 178 [34-402] days, 7 lead dislodgement (3 HBP and 4 LBBP) were recorded. All the others showed stability of the electrical parameters.

Conclusion

The Selectra3D introducers effectively supports CSP ensuring procedural success rate>90%. The 55-M curve fits for most of the anatomies, the 45-S curve allows to reach more proximal target, the 65-L curve more distal target in dilated atria. The electrical parameters were optimal at implant and remained stable during follow-up. 6% lead dislodgement were recorded.
The use of artificial intelligence and deep learning methods in subcutaneous implantable cardioverter defibrillator screening to optimise selection in special patient populations
Authors: Elrefai M , Abouelasaad M , Conibear I , Wiles B , Dunn A , Coniglio S , Zemkoho A , Roberts P
Published: May 2022

Funding Acknowledgements

Type of funding sources: Private company. Main funding source(s): Dr.Mohamed ElRefai is receiving an unrestricted grant from Boston Scientific.

Introduction

Adult congenital heart disease (ACHD) and hypertrophic cardiomyopathy (HCM) patients who require defibrillator therapy are often relatively young and may require several generator replacements in their lifetime. The increased risk of complications associated with transvenous ICDs make the subcutaneous (S-ICD) a valuable alternative. However, higher S-ICD ineligibility rates (20-40% in ACHD and 7-38% in HCM) and higher inappropriate shock rates (10.5% in ACHD and 12.5% in HCM) are observed in these populations. Unfavourable T:R ratios and dynamic changes in the R and T wave amplitudes are the primarily factors behind ineligibility and inappropriate shocks, which are most commonly caused by T wave over-sensing.

Purpose

We report a novel application of deep learning methods used to autonomously screen patients for S-ICD eligibility over a longer period than conventional screening. We hypothesise that this screening approach might achieve better patient selection and optimise S-ICD vector selection in challenging patient cohorts.

Methods

Adult patients with ACHD or HCM and a control group of normal subjects were fitted with a 24-hour ambulatory ECG with the leads placed to record their S-ICD vectors. T: R ratio throughout the recordings was analysed utilising phase space reconstruction matrices to convert the ECG signal into compressed pixel images. Whilst a convolutional neural network model was trained to provide an in-depth description of the T: R variation plot for each vector T: R variation was compared statistically using a one-way ANOVA test.

Results

20 patients (age 44.1 ±11.68, 60% male, 7 HCM, 6 ACHD and 7 control subjects) were enrolled. A significant difference was observed in the mean and median T: R values between the three groups (p<0.001). There was no difference observed in the standard deviation of T: R between the control subjects and HCM group. However, there was a statistically significant difference in the standard deviation of T: R between the control subjects and the ACHD group (p= 0.01). [see Figure].

Conclusions

T:R ratio, a main determinant for S-ICD eligibility, is significantly higher in ACHD and HCM when compared to normal hearts and it also has more tendency to fluctuate in ACHD patients when compared to HCM and normal hearts populations. We hypothesise that our novel model could be used to select S-ICD eligible patients by better characterisation of T:R ratio reducing the risk of T wave oversensing and inappropriate shocks particularly in the ACHD patients’ cohort.
Impact of coronary anatomy and residual syntax score on arrhythmic events in patients with ischemic cardiomyopathy
Authors: Meynet I , Quadri G , Tricomi L , Tomassini F , Rolfo C , Franze’ A , Zanda G , Piedimonte G , Minniti D , Varbella F
Published: May 2022

Funding Acknowledgements

Type of funding sources: None.

Background

ICD implantation is a cornerstone for primary prevention in patients with ischemic cardiomyopathy and impaired left ventricular function; reduced ejection fraction alone, however, doesn’t seem enough to discriminate which patients will really experience arrhythmic events in the follow up.

Purpose

We hypothesized that coronary anatomy and the extent of residual coronary lesions, measured with syntax score, could be a better predictor of the outcome in this setting.

Materials and method

Data of all patients implanted with single or dual chamber ICD in primary prevention for ischemic cardiomyopathy from 2011 to 2020 were retrospectively collected, together with follow up data obtained from clinical visits and ICD remote monitoring. Residual syntax score (RSS) was calculated for each patient, taking into consideration the last coronary angiography performed before ICD implantation.

Results

110 patients were included in our registry. 90.1% were male, mean age was 66±7 years. 23.6% ICD were dual chamber devices. 96 (87.2%), 8 (7.3%) and 6 (5.5%) patients presented respectively with low (0-22), intermediate (23-32) or high (≥33) RSS. After a mean follow up of 4.4±2.9 years, 31 patients (28.2%) died; 20 patients (18.2%) and 27 patients (24.5%) received any appropriate ICD therapy, either shock or ATP. 12 patients (10.9%) experienced inappropriate shock. The composite outcome of death or any appropriate therapy (MACE) was observed in 47 patients (42.7%); left main or left descending artery stenosis were predictors of MACE (p = 0.026 and p = 0.040, respectively). Intermediate or high RSS was the only predictor of appropriate shock (p = 0.046).

Conclusions

Coronary anatomy and residual coronary stenosis quantified with syntax score are promising predictors of arrhytmic events during the follow up in patients with ischaemic cardiomyopathy and ICD implanted in primary prevention.
Intraoperative defibrillation testing during replacements of implantable cardioverter-defibrillators: The Simpler trial
Authors: Milman A , Nof E , Beinart R , Regev E , Rav Acha M , Kutyifa V , Merkely B , Biffi M , Cha YM , Ovdat T , Klempfner R , Glikson M
Published: May 2022

Funding Acknowledgements

Type of funding sources: Foundation. Main funding source(s): Maurice Kahn Foundation via the Mayo- Sheba Collaboration Fund.

Background

The need for intraoperative defibrillation testing (DFT) during implant and/or replacement of implantable cardioverter-defibrillators (ICDs) has been a matter of debate for many years. This debate was put to rest by the Simple and the Nordic ICD trials, and the practice of testing during new implantations has practically been nearly abandoned.

Nevertheless, induction of VF for testing purposes (VFT) may still have an important role in selective populations at risk for defibrillation failure, who were not included in the SIMPLE and Nordic trials. One such population includes those who undergo device replacements. Old registries demonstrated an increased incidence of significant findings in VFT during replacements. In the present study, we sought to test this observation.

Objectives

Evaluate frequency of significant findings and the safety of VFT in subjects undergoing device replacement.

Methods

A prospective observational multi-center study of VFT included consecutive patients undergoing ICD generator replacement in 5 centers in Israel, Europe, and the US. All centers followed the same VFT protocol. The primary outcome was defined as failure to terminate induced VF with a single shock at 10 Joules below the maximal capacity of the device. Secondary outcomes included complications of VFT. Patients were followed-up at 1 month and 6 months post-procedure. Data collection included documentation of any peri-operative complications and clinical endpoints (occurrence of appropriate shock, inappropriate shocks, lead failure, need for re-intervention, and infection).

Results

A total of 92 patients were eligible, and consented for the study, of which 84 underwent DFT during battery replacement. The median age was 68 years and 79.8% were male subjects. Induction of VF was successful in all 84 patients as well as VFT with a successful conversion on first attempt. During follow up one patient had two appropriate ICD shock events. In four patients, the ICD programming was changed. None suffered an inappropriate shock. There was no evidence of lead malfunction. A total of two deaths occurred, none of which were related to the device.

Conclusion

The present study found VFT was not associated with complications in patients undergoing ICD/CRTD generator replacement but produced no clinically important information.
How to better identify patients at high risk of inappropriate shocks before S-ICD implantation: Results from a multicenter experience
Authors: Ben Kilani M , Jacon P , Badenco N , Marquie C , Ollitrault P , Behar N , Khattar P , Carabelli A , Venier S , Defaye P
Published: May 2022

Funding Acknowledgements

Type of funding sources: None.

Introduction

Despite the recent improvements, inappropriate shocks (IAS) in patients implanted with subcutaneous implantable cardioverter-defibrillator (S-ICD) remain a challenge in "real-life" practice. The purpose of this study was to assess the preoperative predictive factors of IAS with the latest generation of S-ICD, with a particular focus on data obtained during the screening procedure.

Methods

Between January 2017 and March 2020, 300 patients implanted with Generation 3 S-ICD system for primary and secondary prevention were included in this multicentric study. Follow-up (FU) of at least 6 months and preoperative screening procedure data were mandatory for all patients.

Results

After a mean follow-up of 22.8 (±11.4) months, appropriate therapies occurred in 12.3% patients; while 26 patients (8.7%) experienced inappropriate therapies (incidence 4.9 per 100 patient-years). The total number of inappropriate shock episodes was 48; 9 patients experienced multiple episodes. Causes of IAS were: supraventricular arrhythmias (34.6%), cardiac (30.7%) and extra-cardiac noise oversensing (38.4%). In univariate analysis, availability of all 3 sensing vectors during preoperative screening significantly reduced inappropriate therapies occurrence (hazard ratio [HR], 0.32; 95% confidence interval [CI], 0.12-0.89, P=0.028). Clinical preoperative S-ICD inappropriate shocks predictors were: history of Supraventricular Tachycardia (SVT)(HR, 4.42; 95% CI, 1.45-13.47; P=0.009); overweight (BMI>25: HR, 1.93; 95% CI, 0.83-0.4.48; P=0.13); QRS duration (HR, 1.01; 95% CI, 0.1-1.03; P=0.14) and lower QRS/T wave ratio in lead I (for a threshold < 3: HR, 4.44; 95% CI, 1.88-10.48; P=0.001). By multivariate analysis, independent factors associated with IAS were: the availability of less than 3 sensing vectors during preoperative screening (p<0.05), a low QRS/T wave ratio in lead I (for a threshold <3; p<0.001), history of SVT (p<0.001) and overweight (BMI> 25; p<0.05).

Conclusion

Automatic preoperative screening data is of high interest as a predictor of IAS with a quantitative value. ECG specificities in association with other clinical factors should be taken into consideration to identify patients at high risk for IAS.
Cardiac resynchronization therapy: long-term impact of echocardiographic non-progression
Authors: Monteiro E , Madeira M , Antonio N , Marinho V , Milner J , Sousa P , Ventura M , Cristovao J , Elvas L , Goncalves L
Published: May 2022

Funding Acknowledgements

Type of funding sources: None.

Background

As heart failure (HF) is a progressive disease, there has been a raising idea that considering the absence of echocardiographic improvement as non-response to cardiac resynchronization therapy (CRT) may not be appropriate. In fact, in some classical echocardiographic non-responders, CRT might have prevented HF deterioration.

Purpose

Our aim was to compare the composite outcome of death and re-admissions due to HF according to a new classification of CRT response: responders, non-progressors and progressors.

Methods

We included 144 consecutive patients with HF, left ventricle (LV) ejection fraction < 40% and QRS duration > 120mseg submitted to CRT implantation. Patients were divided into 3 groups according to the variation of LV end-systolic volume (LVESV) at 6-month: ≥15% reduction in LVESV - responders (R); 0–15% reduction in LVESV – non-progressors (NPr); increase in LVESV – progressors (Pr). A long-term follow-up (4.9 ± 2.9 years) was performed targeting mortality and re-admissions due to HF.

Results

In our population, 78 patients (54.2%) were classified as R, 21 (14.5%) as NPr and 45 (31.3%) as Pr. Baseline comparison between groups is presented in table 1. Compared with R, N-Pr had ischemic aetiology more frequently. The prescription of digoxin was more common in Pr. The Kaplan-Meier curves (figure 1) demonstrate that the composite outcome of death and re-admission due to HF had a lower incidence in R, but was similar between N-Pr and Pr. After adjustment of possible confounders (ischemic aetiology and digoxin use), the type of response to CRT remained as the only predictor of outcomes (OR 0.61; CI 0.41-0.90). 144

Conclusion

In our population, patients without progression of HF had a similarly negative prognosis to the ones that deteriorated. Hence, positive LV remodelling, and not only stabilization seems to be necessary to improve long-term prognosis.
Evaluation of left ventricular dyssynchrony by ultra-high-frequency ECG in patients with non-LBBB conduction disorder treated with cardiac resynchronization therapy
Authors: Roubicek T , Hodbodova M , Pidhorodecky J , Bitmanova B , Cerny J , Morava J , Jurak P , Polasek R
Published: May 2022

Funding Acknowledgements

Type of funding sources: None.

Introduction

LBBB is a reliable left ventricular (LV) electrical dyssynchrony indicator. Patients with RBBB/IVCD are a heterogeneous group, where even with "larger" QRS complex expansion, LV dyssynchrony may not be present. Ultra-high-frequency (UHF) 14-lead ECG is a non-invasive method based on signal averaging that allows better assessment of local electrical activation of the ventricles than standard ECG. Our study aims to test the hypothesis of the usefulness of UHF ECG to select non-LBBB patients for cardiac resynchronization therapy (CRT) based on evidence of electrical dyssynchrony.

Methods

Using UHF ECG we analysed patients who underwent CRT implantation. The groups of patients with RBBB, IVCD, and LBBB were compared and the presence of electrical dyssynchrony (e-DYS) as a parameter of global ventricular activation, and delayed activation of the left ventricular lateral wall (LVLWd) as a marker of LV intravenricular dyssynchrony was assessed.

Results

UHF ECG was recorded in 49 patients treated with CRT. IVCD patients had lower e-DYS compared to LBBB patients (26±17 ms vs. 86±20 ms; p<0.0001) and lower LVLWd (26±16 ms vs. 83±22 ms; p<0.0001). In RBBB patients, e-DYS was -52±22 ms, corresponding to right ventricular delay. Delayed left ventricular free wall activation ("RBBB masking LBBB" activation pattern) was not found in any RBBB patient.

Conclusion

UHF ECG appears to be a promising tool to detect LV electrical dyssynchrony in non-LBBB candidates for cardiac resynchronization therapy. Delayed left ventricular free wall activation was not found in any RBBB patient. Our findings are consistent with the lack of effect of CRT in this group of patients.
Heart failure medication and its effect on response to cardiac resynchronisation therapy in patients with pacing-induced cardiomyopathy: an UPGRADE post hoc analysis
Authors: Barbieri F , Spitaler P , Adukauskaite A , Rubatscher A , Schgoer W , Pfeifer B , Hintringer F , Dichtl W
Published: May 2022

Funding Acknowledgements

Type of funding sources: Other. Main funding source(s): Austrian National Bank

Unlimited scientific grant from the Boston Scientific Investigator Sponsored Research (ISR) Committee

Background/Introduction

Current heart failure (HF) guidelines recommend optimal medical therapy (OMT) in patients with pacing-induced cardiomyopathy (PICM) prior upgrading to cardiac resynchronisation therapy (CRT). It is unknown, whether previous prescription of heart failure medication reduces the effect of CRT upgrading.

Purpose

To evaluate the effect of HF medication on CRT response in patients suffering from PICM receiving an upgrade to CRT.

Methods

The UPGRADE trial was a prospective investigator driven trial evaluating the effect of CRT upgrading in patients with PICM. Key inclusion criteria were symptomatic HF with left ventricular ejection fraction (LVEF) below 40% despite OMT and right ventricular pacing (RVP) above 40%. Device programming had to be adjusted to minimize RVP prior to enrolment. Echocardiographic examinations were performed prior to device implantation and 3-5 months after activation of CRT and were analyzed in blinded fashion. CRT response was defined by a reduction of > 15% in left ventricular end systolic volume (LVESV). Heart failure medication was assessed at implantation of the device.

Results

Overall, 54 patients were enrolled in the UPGRADE trial between 2014 and 2018. Beta-blockers (BB) were prescribed in 43 (79.6%), mineralcorticoid receptor antagonists (MRA) in 29 (53.7%) and either an angiotensin-converting enzyme (ACE) inhibitor or an angiotensin II receptor blockers (ARB) in 45 (83.3%) of the patients. Therapy with CRT has led to significant improvement in LVEF (mean delta: 12.8 ± 7.8%) and LVESV (delta: 30.7 ± 33.2ml), whereas CRT response was achieved in 30 (55.6%) patients. There was no statistically significant difference in patients with BB intake regarding increase of LVEF (12.4 ± 7.5% vs. 14.6 ± 9.4%, p=0.431), decrease of LVESV (42.8 ± 32.8ml vs. 27.8 ± 33.0ml, p=0.201) or CRT response (22 (53.7%) vs. 8 (80%), p=0.167). Similar results were found regarding ACE inhibitor/ARB [LVEF: 13.1 ± 6.8% vs. 11.5 ± 11.8%, p=0.705; LVESV: 32.6 ± 32.6ml vs. 21.7 ± 36.3ml, p=0.373; CRT response: 26 (61.9%) vs. 4 (44.4%), p=0.460] and MRA intake [LVEF: 13.7 ± 7.3% vs. 11.8 ± 8.4%, p=0.382; LVESV: 34.3 ± 36.8ml vs. 26.7 ± 28.8ml, p=0.423; CRT response: 15 (55.6%) vs. 15 (62.5%), p=0.777].

Conclusion

Previous prescription of heart failure medication did not reduce the effect of CRT upgrading in patients suffering from PICM. It remains to be proven, whether similar results may be observed for newer HF agents like sodium-glucose co-transporter 2 inhibitors or angiotensin receptor-neprilysin inhibitors as both were not available in clinical routine at the time of study conduct.
The effect of implantable cardioverter defibrillator in patients with cardiac resynchronizational therapy and diabetes mellitus
Authors: Masszi R , Merkel E , Schwertner W , Veres B , Behon A , Pinter A , Osztheimer I , Zima E , Geller L , Becker D , Kosztin A , Merkely B
Published: May 2022

Funding Acknowledgements

Type of funding sources: Public grant(s) – National budget only. Main funding source(s): (NKFIA; NVKP_16-1-2016-0017 National Heart Program).

Background

Heart failure (HF) and diabetes mellitus (DM) are common causes of death on their own, but the coexistance of these two diseases are especially fatal. 1 In DM, sudden cardiac death (SCD) is more common than in non-DM patients, however in many cases, implantable cardioverter defibrillator (ICD) could not prevent SCD. 2

Purpose

Our aim is to decide which device warrant higher life expectancy, cardiac resynchronizational therapy with or without defibrillator.

Methods

We examined retrospectively 2525 CRT implanted patients, with a mean follow-up time of 4.6 years. Implantaions were based on the current guidelines. The primary endpoint was all-cause mortality, while our composite end-point were all-cause mortality and heart failure hospitalization.

Results

In our population, 928 people (36%) had diabetes. We did not find statistical differences between age (68 vs. 68 years; p<0.099), gender (26% women, 23% women; p<0.08) LVEF (28% vs. 29% p<0.1425), incidence of atrial fibrillation (37% vs. 38%; p<0.76), implantation of an ICD (53% vs. 54%; p<0.847), NT-proBNP median levels (2939 pg/ml vs. 2778 pg/ml; p<0.35), and NYHA I (0,5% vs. 0,5%; p<0.898), and NYHA IV stadium (11% vs. 11%; p<0,82). However DM patients had higher BMI (28 kg/m2 vs. 26 kg/m2; p<0.001), lower eGFR levels (57 ml/min/1,73m2 vs. 60 ml/min/1,73m2; p<0.011) higher prevalence of hypertonia (82% vs. 66%; p<0.001), NYHA III stadium (39% vs. 33%; p<0,0008), ischemic etiology (56% vs. 44%; p<0.001), previous acute myocardial infartion (42,9% vs. 36%; p<0.001), a percutan coronaria intervention (35% vs. 25%; p<0.001) compared to non-DM patients. Those patients with DM showed a 25% higher risk of all-cause mortality (HR 1.25; 95% CI 1.12-1.40; p‹0.01) then non-DM patientes, also observable after adjusting for relevant clinical covariates such as age, gender, atrial fibrillation and the addition of an ICD (HR 1.17; 95% CI 1.06-1.31; p‹0.01).

Conclusions

Adding an ICD for CRT patients with diabetes reduces the risk of all-cause mortality significantly by 32% (HR 0,68; CI 0,56-0,82; p‹0.001) during the first six years but diminished on longer follow-up time (HR 0,95; CI 0,80-1,12; p=0,54).
Effects of lockdown on physical activity and arrhythmia burden in patients with an implantable cardioverter-defibrillator: the Covid-19 Lockdown ICD-Carelink (CLIC) study
Authors: Ghossein MA , Linz DK , Van Kraaij D , De Melis M , Vernooy K , Heijman J
Published: May 2022

Funding Acknowledgements

Type of funding sources: None.

Background: Both COVID-19 and the measures taken to control the pandemic may significantly affect cardiovascular health. The effects of a lockdown on physical activity and its potential consequences for arrhythmia burden remain largely unknown.

Purpose: In this study, we investigated the effect of the lockdown during the first COVID-19 wave on patients’ physical activity and arrhythmia burden.

Methods: All patients with an ICD connected to a Carelink home-monitoring system from two Dutch hospitals were included. Anonymized data on physical activity, heart rate, and occurrence of ventricular tachycardia/fibrillation (VT/VF), and atrial fibrillation/tachycardia (AF/AT) were obtained and were compared between March-April 2020 (lockdown) and March-April 2019 (reference) within each patient. The study was approved by the local ethics committee.

Results: The ICDs of 531 patients registered significantly less activity during de lockdown period compared to the reference period (21,895±12,394min vs 25,173±12,532min, p<0.0001, panel a). Daytime and nighttime heart rates were significantly lower during lockdown compared to the reference period (71.3±9bpm vs 72.6±9bpm, p<0.0001 and 63.4±9 vs 63.8±9, p=0.02, respectively). 94 patients with VT/VF during the reference period did not show any VT/VF during lockdown, while only 4 patients without VT/VF during the reference period showed VT/VF during lockdown (p<0.0001, panel B). There was no significant difference in the occurrence of NSVT or AF/AT.

Conclusion: During the lockdown in the first COVID-19 wave, the Carelink system revealed significantly less activity and lower heart rates. Moreover, there was a significant reduction in the occurrence of VT/VF.
Diagnostic evaluation of implantable loop recorder devices associated with remote monitoring: a retrospective multicentric study
Authors: Ricciardi D , Aurino L , Sanasi L
Published: May 2022

Funding Acknowledgements

Type of funding sources: None.

It has been proven that Implantable Loop Recorders (ILRs) and remote monitoring could improve diagnostic rate, shorten time-to-diagnosis and thus better patient’s clinical outcome. Medical indications to ILRs have been lately extended, and many technical improvements have been achieved in the last few years. Nowadays many different ILRs are available, therefore choosing the best device, according to the patient’s clinical features, could help to reach an optimal patient management.

Aim of this retrospective multicentric study is to compare which is best between 2nd generation ILR Medtronic Reveal™ LINQ (MRL) or St. Jude Medical Confirm™ RX (SCX), both associated with remote monitoring, in terms of overall accuracy rate (OAR), true positive detection rate (TPDR) and arrhythmias-free survival (AFS).

Patients included in the study required an ILR implant for syncope, non-recurring heartbeat, suspect AF, Brugada Syndrome, post-ablation AF monitoring and non-stustained ventricular tachycardia. Medtronic Reveal™ LINQ (n=436, mean age 66±15, mean BMI 30±5) and St. Jude Medical Confirm™ RX (n=98, mean age 64±14, BMI 27.5±4) implanted patients underwent a weekly remote and a six-monthly outpatient follow-up. Every transmission was judged by two different cardiologists. The final diagnosis was set only in case of agreement, conversely, the transmission was discussed either considered non-diagnostic. Patients were studied for atrial fibrillation (AF), pauses (Ps), bradycardias (Bs) and tachycardias (Ts).

MRL transmitted 5585 times, SCX 7545 (monthly transmission/patient ratio 25.5±45.6 vs 0.9±1.1 respectively). MRL had statistically significant better OAR for AF (61% vs 14%, p<0,001), Ps (20% vs 7%, p<0.001) and Bs (72% vs 20%, p<0.001). SCX had statistically better OAR for Ts (84% vs 56%, p<0.001). MRL had statistically significant better TPDR for AF alone (82% vs 48%, p<0.001) and non-statistically significant better TPDR for Ps (32% vs 28%, p=0.117), Bs (48% vs 38%, p=0.133) and Ts (69% vs 69%, p=0.505). Patient with MRL had better AFS at a six-months follow-up (72% vs 20%, p<0.001). The overall accuracy rate for every arrhythmic episode was better in MRL implanted patients than in the SCX implanted ones (43% vs 16%, p=0.001).

Transmission rate was higher in SCX, even though MRL had a better accuracy in detecting real arrhythmic events. The overall accuracy rate of arrhythmic events in both groups is sub-optimal, therefore further engineering research is required to improve diagnostic accuracy of ILRs.
Temporal trend of QRS voltage amplitude on surface sensing in patients with arrhythmogenic cardiomyopathy implanted with a subcutaneous ICD
Authors: Casula M , De Toni C , Pignalosa L , Savastano S , Schintu B , Sanzo A , Scalone A , Tola G , Corda M , Vicentini A , Rordorf R
Published: May 2022

Funding Acknowledgements

Type of funding sources: None.

Introduction

Previous studies have reported a significant decrease in ventricular sensing amplitude during follow-up in patients with arrhythmogenic cardiomyopathy (ACM) implanted with trans-venous implantable cardioverter defibrillator (ICD). No data are yet available on sensing amplitudes values over time for subcutaneous ICD (S-ICD). Low QRS voltage on surface ECG is one of the diagnostic clues in ACM. This, together with the progressive nature of the disease and the not-negligible incidence of inappropriate shocks due to oversensing, raise safety concerns on the use of S-ICD in this population.

Aim

The aim of this study was to evaluate the trend of QRS amplitude on subcutaneous ECG (S-ECG) over time in patients with ACM implanted with S-ICD.

Methods

We conducted a retrospective analysis on a cohort of consecutive patients with ACM implanted with S-ICD in two tertiary centers, prospectively enrolled in the home-monitoring program. The S-ECGs recorded by the S-ICD at the time of first and last data transmission were analyzed. The voltage amplitude was estimated for each QRS complex available, and the values obtained were compared between the two time points (i.e. baseline and last follow-up available). The primary endpoint of our study was the proportion of patients in which the decrease of QRS amplitude during follow-up was statistically significant.

Results

Eleven patients (1 female, 9%) were enrolled in this study. The mean age was 43±10 years. An exclusive right ventricular involvement was reported in 5 patients (46%), 2 patients (18%) had an exclusive left ventricular, and 4 (36%) a biventricular involvement. Three patients (27%) were implanted in secondary prevention. During a median follow-up of 9 months (IQR 6-17), 6 patients (55%, 95%CI 24-84%) experienced a statistically significant reduction in the S-ECG QRS amplitude (Figure A). Considering these 6 patients, the mean absolute reduction was -0.46±0.32 mV corresponding to a relative reduction of -19%±11%. Moreover, we found a statistically significant correlation between follow-up duration and QRS amplitude relative reduction (r=-0.89, p=0.018, Figure B). No patients experienced inappropriate shocks.

Conclusions

In a cohort of ACM patients implanted with S-ICD the majority of patients experienced a significant reduction in the amplitude of QRS voltage during follow-up, confirming a potential safety concern on the use of S-ICD in this population. Further studies are needed to investigate this issue.
Leadless pacemakers as replacement for infected transvenous pacemakers: different strategies are feasible
Authors: Breeman KTN , Beurskens NEG , Wilde AAM , Tjong FVY , Knops RE
Published: May 2022

Funding Acknowledgements

Type of funding sources: None.

Introduction

Pacemaker infections have a high morbidity and mortality and are an indication for extraction. For reimplantation, leadless pacemakers (LPs) may be preferable due to a low chance of infection. Even more, early LP reimplantation in pacemaker-dependent patients would circumvent the need for temporary pacemakers.

Methods

We included all patients with LP implantation before, simultaneously with, or after transvenous pacemaker extraction due to infection, between January 2013 and December 2021. Outcomes were assessed during standard follow-up visits.

Results

30 patients (mean age 81±8 years) were included, of which 19 (63%) had a pocket infection, 10 (33%) endocarditis and 1 (3%) a systemic infection without endocarditis (Table). LP implantation was successful in all and was performed before extraction in 2 patients (7%; 3 and 5 days before), simultaneously in 6 (20%) and after extraction in 22 (73%). There were 3 procedural complications: 2 femoral artery bleedings and one LP dislocation. Also, one patient with complete AV block and an initially stable escape rhythm had an in-hospital cardiac arrest due to asystole after transvenous pacemaker extraction, but before LP implantation. During follow-up of median 21 months (IQR 7-53 months), no reinfection occurred. Six Nanostims were extracted due to early battery depletion, prophylactically after the battery advisory, or due to non-capture (median 36 months [range 0-67 months] after implantation); histopathologic examination of tissues around the devices showed no signs of infection. Two Nanostims were abandoned after which another device was implanted. No further device revisions were necessary during follow-up.

Conclusions

In case of transvenous pacemaker infection, LP implantation before, simultaneously with or after extraction is safe and effective.
Venoplasty can be performed safely and successfully in patients with subtotal and total venous occlusion needing additional transvenous electrodes
Authors: Maass A , Lankveld TAR , Gkouskos D , Groenveld HF , De Haan M , Rienstra M , Lipsic E , Vernooy K
Published: May 2022

Funding Acknowledgements

Type of funding sources: None.

Introduction

Lead failure, but also upgrade procedures from pacemaker to implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy (CRT) can be hampered by venous obstruction occurring in 10-25% of patients with prior transvenous electrodes. A relatively underused technique to overcome venous obstruction are lead percutaneous venous dilation procedures (venoplasty).

Purpose

We aimed to identify the feasibility of venoplasty procedures in two Dutch tertiary referral centers.

Methods

84 consecutive patients where venoplasty was attempted were included in the study and baseline parameters as well as procedural characteristics and complications were recorded. 42% of patients needed replacement of a defective electrode and 58% an upgrade to CRT or from pacemaker to ICD. Venous stenosis was defined as significant (70-90%), subocclusive (90-99%) and occlusive (100%) and the region was divided into three segments: subclavian vein, brachiocephalic vein and junction to the vena cava superior.

Results

The study included 30 pacemaker and 54 ICD patients, 68±12 years old, 80% were male. Body mass index was 26±3, left ventricular ejection fraction 32±12% and eGFR 63±24ml/min/1,73m2. At the time of the procedure, 2,1±0,8 electrodes were present and 1,2±0,2 electrodes were implanted, in 15% atrial, 52% RV and 52% LV electrodes. The procedures took 123±58 minutes and fluoroscopy dose was 5334±5390µGy/m2. There were 79 total occlusions of any segments and in addition, 51 subocclusive lesions needing venoplasty (table). 8 procedures were unsuccessful (9%), mostly due to failure to pass the occlusion. 3 patients (4%) had pocket hematoma not needing reintervention and one patient (1%) needed lead repositioning due to dislocation. There was no damage to any existing lead during the procedures. 89% of patients had a successful procedure without a complication needing reintervention.

Conclusions

Venoplasty is safe in subocclusive and occlusive venous stenosis and can be performed with high success using modern material potentially avoiding lead extraction or contralateral tunneling procedures.
Predicting long-term mortality following transvenous lead extraction using the lead extraction difficulty (LED) index score
Authors: Mitacchione G , Bontempi L , Arabia G , Forleo G , Cimino G , Amore L , Cerini M , Curnis A
Published: May 2022

Funding Acknowledgements

Type of funding sources: None.

Background

Transvenous Lead Extraction (TLE) scoring systems have proven to be a reliable method to predict TLE difficulty, thus improving procedure safety and efficacy. Nevertheless, TLE has shown a significant mortality rate during the subsequent follow-up, up to 33% at 10 years, with historical data showing several procedural and clinical characteristics associate with this poor outcome.

Purpose

We aimed to investigate the association between difficult TLE procedures and long-term mortality, using a specific scoring system [Lead Extraction Difficulty (LED)] to identify difficult/simple procedures.

Methods

Consecutive patients underwent TLE procedures between January 2014 and January 2016 at Spedali Civili Hospital, Brescia, Italy, were prospectively considered to receive a follow-up during 2021. TLE difficulty was retrospectively assessed in all patients using the LED index score (number of leads to extract + years from implant of the oldest lead to remove + 1 [for a dual-coil implantable cardioverter defibrillator lead] – 1 [in case of confirmed vegetations along the lead]). According to the score, "high-difficult" procedures were defined for a LED >10. Patient long-term follow-up was obtained by review of medical records from patient surveys or from the referring institution/family practitioner. Univariate analysis and multivariate logistic regression were used to identify factors associated with long-term mortality. Kaplan-Meier estimates were used to investigate survival during the follow-up. Two-sided P<.05 was considered significant.

Results

A total of 466 permanent leads were removed in 249 patients with a clinical success rate of 99.1%, and without major acute complications. The mean time follow-up was 6.7 (5.9-7.1) years, with a cumulative all-cause mortality rate of 17.7%. Clinical characteristics, indication for TLE, and mortality during follow-up are reported in the Table. Among all variable associated with mortality at univariate analysis, only LED index >10 independently predicted the mortality during the follow-up at logistic regression (OR 2.98; 95% CI: 0.081-1.4; p=0.028). Survival plots for individuals underwent high/low difficult TLE are shown in the Figure. Mortality at 1, 3, and 5 years following TLE was highest among patients with LED index >10 (1.1%, 12.6%, and 26.3%, respectively).

Conclusions

Cumulative long-term mortality following TLE was confirmed to be high. Of interest it resulted highest among patients following high-difficult TLE procedure. LED index score resulted a useful tool to predict long-term mortality after procedure. This finding should be considered when approaching TLE procedures in order to estimate the risk/benefit ratio over the time.
Procalcitonin as a biomarker of cardiac implantable electronic device pocket infection: a prospective validation study
Authors: Knoll K , Oconnor M , Chouchane A , Haller B , Schaarschmidt C , Bock M , Foerschner L , Froehlich R , Kottmaier M , Bourier F , Reents T , Hessling G , Deisenhofer I , Kolb C , Lennerz C
Published: May 2022

Funding Acknowledgements

Type of funding sources: None.

Introduction

The implantation of cardiac implantable electronic devices (CIEDs) such as pacemakers and implantable cardioverter-defibrillators is increasing along with the complexitly of these devices. CIED infection is an uncommon, but severe complication associated with the presence of a device and is associated with a high mortality and morbidity. Lead-related infections and frank endocarditis are associated with a systemic inflammatory response and, in general, are readily identified. Isolated pocket infections do not produce such a systemic response and are thus more complex to diagnose. There is a reliance on clinical accumen and examination of local signs of infection. There is thus a need for a reliable biomaker to help identify cases of pocket infection.

Aim

Our group have previously shown procalcitonin (PCT) to be a potentially useful biomaker in the clinial situation of possible pocket infection. We aim to prospectively validate the proposed cut-off value of 0.05ng/ml for the procalcitonin (PCT) biomaker in an independent cohort, which we have previously identified as showing promise in this clinical situation.

Methods

In this prospective case-control validation study the PCT levels of 81 patients with confirmed pocket infections were compared to 81 controls, matched for age and renal function, presenting for elective generator replacement or lead revision unrelated to infection. Exclusion criteria included: concomitant infectious or inflammatory diseases, end-stage renal failure, active malignancy or receiving immunosuppressive therapy.

Results

A PCT over 0.05 ng/ml was found in 68% (n= 55) of pocket infections and 24% (n= 19) of controls. Using the pre­defined cut-off value of 0.05 ng/ml PCT had a sensitivity of 68% and a specificity of 77% for diagnosing pocket infections. ROC analysis revealed area under the curve of 0.752 (standard error 0.039, p <0.001 ) for PCT. In patients presenting with minimal infective signs the sensivity remained high (67% vs 70% with extensive inflammation) and similarly remained high in thus who had received anti-biotic therapy prior to PCT sampling (65% vs 69%).

Conclusion

PCT is a potentially useful biomarker to aid the diagnosis of a pocket infection when used with the prospecitvely validated cut-off value of 0.05ng/ml. The sensitivity of the PCT positive result remained high even in patients pre-treated with antibiotics or with minimal clinical signs of inflammation.