bluuebunny/crossref_metadata_2025 huggingface dataset:
Non-sustained ventricular arrhythmias at exercise ECG predict severe ventricular arrhythmias in arrhythmic mitral valve prolapse
Authors: Five C K , Hasselberg N E , Chivulescu M , Rootwelt-Norberg C , Ribe M P , Dejgaard L , Castrini A I , Aabel E W , Haugaa K H
Published: October 2022

Background

A subset of patients with mitral valve prolapse experience ventricular arrhythmias (VA) and even sudden cardiac death, defined as arrhythmic mitral valve prolapse (AMVP). Risk stratification of VA is challenging in this relatively young population. The predictive role of exercise testing has not been investigated.

Purpose

We aimed to explore if VA burden on exercise ECG can predict severe ventricular arrhythmic events in AMVP patients.

Methods

We included consecutive AMVP patients without prior severe VA referred to our tertiary center. Exercise bicycle ECG test by standard protocol was performed at inclusion. Non-sustained VT (nsVT) during exercise testing was defined as ≥3 consecutive ventricular beats with a rate ≥100/min lasting <30 seconds. Our endpoint of severe VA during follow-up was defined as aborted cardiac arrest, sustained ventricular tachycardia, nsVT with syncope or appropriate ICD shock therapy detected by either ECG, Holter monitoring, implantable loop recorder or primary preventive ICD.

Results

We included 91 AMVP patients without prior severe VA (51±16 years of age, 63% women) with exercise test at baseline. NsVT occurred in 5 patients during exercise testing. During 67±7 months of follow-up, 5 (5.5%) patients experienced severe VA. In all, 3 of the 5 (60%) with nsVT at exercise test experienced severe VA during follow-up, compared to only 2 of 86 (2%) without nsVT at exercise testing (age adjusted hazard ratio [HR] 35 [95% CI 5–249], p<0.001). Survival free from severe VA was worse in those with nsVT at exercise test (log rank p<0.001) (Figure 1).

Conclusions

Non-sustained VT occurring during exercise ECG testing was a strong marker of subsequent severe VA in AMVP patients without previous severe VA. These novel findings indicate that exercise testing may improve risk stratification in AMVP patients.

Funding Acknowledgement

Type of funding sources: Other. Main funding source(s): The Research Council of Norway.
Arrhythmia detection using insertable cardiac monitors after a negative electrophysiology study in Brugada syndrome: observations from a multicenter Spanish registry
Authors: Garcia-Izquierdo Jaen E , Palacios-Rubio J , Ripoll-Vera T , Hernandez-Betancor I , Ramos-Ruiz P , Diaz-Infante E , Macias-Ruiz R , Segura-Dominguez M , Garcia-Rodriguez D , Aguilera-Agudo C , Jimenez-Sanchez D , De La Rosa Y , Castro-Urda V , Toquero-Ramos J , Fernandez-Lozano I
Published: October 2022

Background/Introduction

Risk stratification in Brugada syndrome (BrS) remains controversial. In this respect, the role of electrophysiology study (EPS) has been subject of debate. It is common practice in some centers to implant an insertable cardiac monitor (ICM) after a negative EPS, especially in the presence of unexplained symptoms. However, the diagnostic value of this approach has never been specifically addressed.

Purpose

We aimed to describe the baseline characteristics and the main findings of a diagnostic work-up strategy using an insertable cardiac monitor (ICM) after a negative EPS in patients with BrS.

Methods

We retrospectively evaluated data from a multicenter registry including 56 BrS patients from 7 referral hospitals who received an ICM to help risk stratification. Only patients with a negative EPS (ie, non-inducible VT/VF) prior to ICM implantation were considered for this analysis. EPS protocols differed across hospitals (see Figure 1)

Results

A total of 26 patients from 5 different hospitals were studied. Mean age was 33.0±12.8 and 77% were male. Spontaneous type 1 pattern was present in 12 patients (46%). Positive genotype was found in 10 (38%) and family history of sudden cardiac death was present in 11 (42%). Previous symptoms were syncope/presyncope in 15 patients (58%) and palpitations in 3 patients (12%). The rest of the patients (30%) were asymptomatic. After a median follow-up of 33.4 months (IQR 16.5 and 43.1 months), none of the patients presented ventricular arrhythmias. ICM allowed the detection of other arrhythmias in 5 patients (19%), which led to specific therapeutic actions in all but 2 of them (see Table 1). ICM-detected arrhythmias correlated with previously reported symptoms only in one of the patients.

Conclusion

The results of this exploratory analysis support the notion that EPS in BrS has a high negative predictive value for risk stratification. ICM implantation after a negative EPS may allow the detection of incidental arrhythmias during follow-up. Despite the apparent low correlation of these findings with previously reported symptoms, this strategy may lead to important treatment decisions in a significant proportion of patients.

Funding Acknowledgement

Type of funding sources: None.
Healthcare professionals knowledge of inherited cardiac arrhythmias ica their views towards and confidence in caring for a person with an ica in a surgical environment
Authors: McGlinchey L , Barr O , Black P
Published: October 2022

Background

Inherited Cardiac Arrhythmias (ICA) are potentially life-threatening conditions which may be induced by several factors during the perioperative period. Safety and quality of care of patients may be affected by insufficient knowledge, or confidence by healthcare professionals in surgical areas.

Purpose

To determine the knowledge of ICAs by healthcare professionals, their views towards and confidence in caring for a person with an ICA in a surgical environment.

Methods

In Phase One, a twenty-four item questionnaire was distributed to registered nurses and midwives, surgeons and anaesthestists within surgical areas of seventeen hospitals of the Republic of Ireland and Northern Ireland.

Results

Completed questionnaires were returned from 154 participants in Phase 1 involving all four professions of the participant cohort. This comprised of one hundred and seventeen nurses, seven midwives, ten surgeons and nineteen anaesthetists. Sudden Adult/Arrhythmic Death syndrome (SADs) was heard of by 91% of participants, and 54% have heard of ICA. The majority of participants were not at all confident or only slightly confident (48% and 32%) in caring for patients with an ICA. Eighty-four percent were not aware (61.7%) or not sure if they were aware (22.7%) of the drugs to avoid in ICA conditions such as Long QT and Brugada syndrome. Those aware (11%) of drugs to avoid were seven anaethetists, two midwives and eight nurses. Of the ten surgeons, none were aware of the drugs to avoid. When all participants were asked how relevant is knowledge of ICA to your current role 5.8% said it was not at all relevant, 29.2% said it was slightly relevant, 31.8% moderately relevant and 28.6% extremely relevant. Ninety-five percent (95%) of participants would like further education about these conditions delivered mainly by online sessions and face to face workshop methods.

Conclusions

There is limited knowledge of and confidence in caring for people with Inherited Cardiac Arrhythmias in surgical areas of the hospitals surveyed. Education is required in relation to awareness and identification of people with these conditions, signs and symptoms, unmasking and triggering a cardiac event and what medications need to be avoided. Patients may not be aware they have an Inherited Cardiac Arrhythmia, so healthcare professionals' awareness is crucial with the ability to recognise and respond appropriately to a possible cardiac event. There is a need to address these gaps as these have potential serious implications for people with an ICA during their perioperative journey.

Funding Acknowledgement

Type of funding sources: Other. Main funding source(s): The Cormac Trust
Stellate ganglion blockade for treatment of ventricular arrhythmia storm: a meta-analysis
Authors: Zafeiropoulos S , Bikou A , Farmakis I T , Doundoulakis I , Giannakoulas G , Zanos S
Published: October 2022

Background

Autonomic neuromodulation and particularly stellate ganglion blockade (SGB) has been tested in ventricular arrhythmia (VA) storm, but there is so far no robust evidence to inform clinical practice and its use remains limited.

Purpose

We aimed to summarize the efficacy and safety of SGB in patients with VA storm.

Methods

We searched PubMed, the Cochrane Library and Scopus from inception to 15th March 2022, for studies performing either pharmacological or electrical SGB in the context of drug-refractory VA storm. Case series with less than 10 patients were excluded. We performed a single-arm random effects meta-analysis of studies to calculate the pooled proportion estimate of freedom from VA recurrence after SBG and the overall mean change of VA burden from baseline.

Results

Of 409 articles identified and screened, we considered eligible six studies comprising a total of 106 patients. The mean age was 61.6±13.9 years, 79.2% were male, the mean left ventricular ejection fraction was 28.8±12.7%, and 47.1% had underlying ischemic cardiomyopathy. In five trials the patients received pharmacological SGB with bupivacaine, ropivacaine, or/and lidocaine (left-sided or bilateral), while in one study transcutaneous magnetic stimulation of the left stellate ganglion was used. The pooled proportion of patients free of VA recurrences was 65% (95% CI 51–78%, I2=46%) at the first 24 hours post-SGB (Figure 1A), and 54% (95% CI 43–64%, I2=0%) at 72 hours (Figure 1B). The number of VA episodes was significantly reduced from a mean baseline of 7.01±8.34 episodes/24h before SGB to 0.93±1.64 episodes/24h after SGB. The mean absolute reduction of VA episodes was 5.44 (95% CI 2.83–8.05, I2=88%) (Figure 1C) while the mean absolute reduction of external or internal defibrillation events was 3.36 (95% CI 0.62–6.09, I2=84%) (Figure 1D). No serious procedure-related complications were reported. The overall in-hospital mortality was 28.4%.

Conclusions

SGB appears an effective and safe treatment in patients with VA storm with approximately 1 in 2 patients exhibiting complete suppression of VA for 72 hours and an approximately 80% mean relative reduction in VA burden.

Funding Acknowledgement

Type of funding sources: None.
Ventricular fibrillation amplitude spectral area as a guide to deliver the optimal energy level for defibrillation
Authors: Gentile F R , Compagnoni S , Baldi E , Primi R , Bendotti S , Currao A , Aramendi E , Isasi I , Contri E , Palo A , Savastano S
Published: October 2022

Introduction

In case of cardiac arrest due to ventricular fibrillation (VF) or pulseless ventricular tachycardia (pVT), the optimal energy should be the lowest energy effective to achieve defibrillation minimizing the current-induced myocardial damage. Therefore, it would be ideal to minimize the energy level as well as the number of shocks during resuscitation. ECG-based VF waveform analysis features such as amplitude spectral area have been recently introduced as predictors of shock success, but their predictivity for shock success with low energy level is not known.

Purpose

To assess whether amplitude spectral area (AMSA) of VF is able to predict the efficacy of low energy level defibrillation in out-of-hospital cardiac arrest (OHCA) patients.

Methods

All the OHCAs with at least one shockable rhythm that occurred from January 2015 to December 2020 were considered. AMSA values were calculated by retrospectively analyzing the data collected by the Corpuls 3 monitors/defibrillators and by using a 2-second-pre-shock ECG interval.

Results

Among 4619 OHCAs, resuscitation was attempted in 2982 (64%) and at least one shock was delivered in 697 (15%). AMSA values and defibrillation energy were available for 791 shocks, of which 45% received shock at low energy (>150J) and 55% at high energy (>150J). The rate of efficacy between the two groups was similar (44% vs 38%, p=0.102). However, in patients efficaciously treated with shock at low energy, AMSA was higher compared to those treated with shock at high energy [13.2 mV Hz (IQR 10.2–17) vs 10.8 mV Hz (IQR 8–13.8), p<0.001]. Moreover, AMSA values were significantly different when comparing ineffective shock at low energy with effective shock at high energy [6.6 mV Hz (IQR 4.6–10) vs 10.8 mV Hz (IQR 8.1–13.8), p<0.001] and similar when comparing ineffective shock at low and high energy [6.6 mV Hz (IQR 4.6–10) vs 6.3 mV Hz (IQR 4.5–8.7), p=0.21]. By dividing AMSA values into three tertiles, the rate of shock success at low energy was statistically different: [T1 (0.7–6.2 mV Hz) 4.2%; T2 (6.2–10.8 mV Hz) 13%; T3 (10.8–63.2 mV Hz) 42%; Chi-squared p<0.001 and p for trend <0.001]. After correction for age, sex, amiodarone use and call to shock time, AMSA values corresponding to the third and second tertile were associated with higher probability of shock success at low energy compared to the lowest tertile [T3 OR 15 (95% CI 7–30), p<0.001; T2 OR 3 (95% CI 1–7), p=0.002].

Conclusion

Ventricular fibrillation amplitude spectral area is a predictor of shock success at a low energy level. This could be useful to optimize both time and dose-energy to patients, yielding the highest chance for successful defibrillation while reducing the number of futile shocks and thus limiting the total current myocardial energy as well as CPR interruptions.

Funding Acknowledgement

Type of funding sources: None.
Gender differences in amplitude spectral area (AMSA) of ventricular fibrillation in patients with out-of-hospital cardiac arrest
Authors: Quilico F , Vicini Scajola L , Gentile F R , Compagnoni S , Baldi E , Aramendi E , Isasi I , Lopiano C , Primi R , Bendotti S , Currao A , Contri E , Palo A , Savastano S
Published: October 2022

Introduction

Ventricular fibrillation (VF) Amplitude Spectral Area (AMSA) is a well-established predictor of successful defibrillation and return of spontaneous circulation (ROSC). Attending to the limited evidence on the topic, gender seems to affect AMSA, and higher values have been reported in females. The aim of this work was to investigate the effect of gender in AMSA values for patients suffering out-of-hospital cardiac arrest (OHCA).

Methods

We enrolled 4619 consecutive OHCA patients from January 2015 to December 2020 in the LombardiaCare Registry. We considered only those subjects with attempted cardio-pulmonary resuscitation (697 patients) and at least one shock delivered. A total of 250 patients were considered (40 F/ 210 M) with 830 shocks (100 F/ 730 M). AMSA values were computed for the ventricular fibrillation in the 2-s pre-shock interval of the ECG recorded by the Corpuls3 defibrillator (Corpuls, Kaufering, Germany).

Results

Female patients were older than male [median (IQR): 70.5 (62–72) vs 67 (55–75) years, p=0.01], with cardiac arrest more frequently at home (84% vs 76%, p=0.003), fewer shocks [2 (1–4) vs 4 (2–7), p=0.004] and higher percentage of success (53% vs 40%, p=0.009). On the contrary, cardiac arrest duration [ 58.7 (31–69) vs 57.6 (41.4–77.3) min, p=0.366] and the rate of ROSC (32% vs 33%, p=0.88) were similar in both groups.

Higher AMSA values were found in female patients [10.3 Hz-mV (6.6–13.5) vs 7.9 Hz-mV (5.2–12.1), p=0.0007]. At a multivariable analysis, after correction for witnessed status, bystanders CPR, amiodarone administration, age and call-to shock time, male sex was found to be independently associated with the probability of having low values of AMSA, below the median value of 8.3 Hz-mV [OR 2.15 (95% CI1.35–3.43), p=0.001].

Despite gender stratification ROC curve analysis confirmed AMSA as a predictor of shock success [AUC-F: 0.75 (95% CI 0.65–0.83), p<0.001; AUC-M: 0.78 (95% CI 0.74–0.81)] and ROSC [AUC-F: 0.69 (95% CI 0.59–0.68), p=0.008; AUCM: 0.84 (95% CI 0.81–0.87)].

Conclusion

Female sex is related to higher AMSA values. As AMSA reflects the energetical status and the ATP levels in the myocardial cells during cardiac arrest, this difference may be due to lower incidence and lower severity of cardiac ischemic disease in women. AMSA remains a valid predictor of both shock success and ROSC for female and male patients. Further investigations are needed to support and comprehend these conclusions.

Funding Acknowledgement

Type of funding sources: None.
Bipolar ablation of refractory ventricular arrhythmias using a novel dedicated adapter. A multicenter study
Authors: Futyma P , Bordignon S , Imnadze G , Peichl P , Seidl S , Kueffer T , Chen S , Zarebski L , Martinek M , Puererfellner H , Kautzner J , Reichlin T , Sommer P , Chun J K R , Schmidt B
Published: October 2022

Background

Bipolar ablation (BA) recently emerged as an alternative for treatment of ventricular tachycardia (VT) and premature ventricular contractions (PVC) refractory to a classic unipolar ablation (UA). Data on the use of available BA systems is lacking.

Purpose

To determine feasibility, safety and efficacy of a novel BA adapter in consecutive patients with refractory VT/PVC undergoing repeat ablations.

Methods

The study group consisted of consecutive patients with VT/PVC after failure of at least one standard UA who underwent redo procedures performed with a support of BA at six European centers. A second ablation catheter was connected in the position of a return electrode using a novel BA adapter.

Results

Between March 2021 and March 2022 a total number of 19 patients after failed ablation attempts underwent redo procedure using a novel BA adapter (17 males, age 61±11, number of prior ablation attempts 2,5±1,6; range 1–7). The main indication for redo ablation was recurrence of frequent PVC (n=10), VT (n=8) or electrical storm (n=1). Fifteen patients underwent combined UA+BA procedure during redo ablation, whereas 4 remaining patients underwent BA only. Two patients required epicardial access. Mean procedural time was 157±77 minutes. The mean BA time was 367±245s (power 32±9W) and mean UA time was 349±290s (power 43±6W). Apart from 1 anticipated AV block there were no major complications. Minor complications included char formation at 8mm tip electrode and steam pop without sequalae in one VT patient. BA+UA led to acute elimination of clinical PVC/VT in 18 patients. In the remaining 1 patient no effect on clinical VT during UA+BA was observed. The follow up lasted 4±3 months. Six (75%) VT patients remained arrhythmia-free and significant PVC burden reduction was achieved in nine (90%) PVC patients during follow-up. One patient treated for electrical storm experienced a single VT episode after 11 months. One patient after initially failed UA+BA underwent successful bipolar reablation after 2 months.

Conclusions

Bipolar ablation of refractory ventricular arrhythmias using a novel dedicated adapter is feasible, seems safe and effective. These encouraging preliminary results need to be confirmed in properly designed prospective trials.

Funding Acknowledgement

Type of funding sources: None.
Long-term toxicity of radiosurgery for ablation of ventricular tachycardia
Authors: Cvek J , Peichel P , Knybel L , Jiravsky O , Sramko M , Hecko J , Neuwirth R , Plasek J , Kautzner J
Published: October 2022

Introduction

There is a rising interest in using radiosurgery to modify arrhythmogenic substrate in patients with recurrent VT. However, data on the safety are still inadequate.

Purpose

This is update of toxicity evaluation based on the compilation from our case series, NIRA-VT and STAR-VT.

Methods

Between 2014 and March 2021, 36 patients (33 male, 3 females; mean age 66±10 years) with structural heart disease (ischemic cardiopathy, dilated cardiopathy or fibroma associated scar) from two electrophysiology centers in the Czech Republic (Trinec, Prague) underwent radiosurgery for recurrent VT.

Radiosurgery was performed after at least one failed catheter ablation for VT. The critical part of the VT substrate was identified by electroanatomic mapping using a combination of voltage mapping, pace mapping, and activation mapping; and it was marked on a contrast-enhanced computer tomography study as a CTV. In NIRA-VT trial, CTV included scar based on PET/CT evaluation. Radiosurgery system with real-time motion tracking using the tip of the electrode of an indwelling defibrillator as a fiducial marker was used. A total radiation dose of 25 Gy was delivered to the ablation target in a single session during free breathing. Radiation-induced toxicity was evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Only patients with follow up longer than 6 months were included in long term radiation related side effects evaluation.

Results

The mean CTV and PTV were 26±11 ml and 41±22 ml respectively. No patient exhibited acute (up to 3 months) elevation of troponin, pericardial effusion, or a decrease in left ventricular ejection fraction from baseline. Four patients developed acute mild nausea, which waned after antiemetic drugs. Long-term radiation related side effects were evaluated in 19 patients. Two patients (11%) presented radiological signs of lung fibrosis in small area in close distance from PTV. There was no significant decrease in left ventricular ejection fraction during follow up. Six patients (33%) gradually developed significant progression of known mitral regurgitation after SBRT, two (11%) of them had to undergo mitral valve replacement (grade 4 toxicity). Two cases of esophagitis (12%) were seen with one radiation toxicity related death (grade 5 toxicity) due to the unresectable esophagi-pericardial fistula (6%).

Conclusions

Our data indicate the feasibility of radiosurgery, majority of patients presented no/mild radiation related toxicity and decrease of VT burden. However, we have seen three cases of grade 4,5 toxicity. To further investigate long-term safety and efficacy of radiosuergery for VT, enrolling into a randomized prospective study is in progress.

Funding Acknowledgement

Type of funding sources: Public grant(s) – EU funding. Main funding source(s): European Union's Horizon 2020
Diagnosis of channelopathies affects quality of life and psychological status in patients and relatives
Authors: Berne P , Usai F , Silva E , Onida A , Melis I , Casu G
Published: October 2022

Background

Cardiac channelopathies are a group of inherited cardiovascular diseases with increased risk of sudden cardiac death in structurally normal hearts. The psychological status after their diagnosis has not been thoroughly studied.

Purpose

To establish health-related quality of life (QOL) and emotional response to the diagnosis of channelopathies in a cohort of patients and their families.

Methods

Adult patients with diagnosis of channelopathies and their relatives were eligible. After enrolment they were divided in 3 groups, according to the time of psychological evaluation: At diagnosis (T0), one year (T1), and 2 years after diagnosis (T2). Psychological evaluation was conducted through self-report questionnaires on QOL (SF-12), general anxiety (BAI), depression (BDI-II), perceived stress (PSS-10), post-traumatic stress (IES-R), and protective resilience resources (RSA).

Results

From August 2020 to April 2021, 64 patients (95% Brugada syndrome, 3% long QT syndrome, and 2% catecholaminergic polymorphic ventricular tachycardia) and 41 relatives were enrolled. A control group of 105 healthy subjects, matched to the study group regarding age, gender and level of education, was also enrolled.

Patients at T0 showed increased physical and reduced mental QOL; at T1, reduction of RSA; and at T2, reduction of RSA and increased BAI. A significant percentage of patients referred the occurrence of a traumatic event during their lifetime at T0, T1 and T2 (Figure 1). At T0 relatives presented high PSS-10 and a high proportion of them reported experiencing a traumatic episode during their lifetime. BAI score was high among relatives at T0, T1 and T2, reaching levels of concern 2 years after the diagnosis (Figure 2). Female gender independently predicted MCS-12 in patients at T0.

Conclusions

Diagnosis of channelopathies impact different areas of QOL and the psychological sphere in patients (QOL, resilience, anxiety and occurrence of traumatic events during lifetime) and relatives (anxiety, stress, and occurrence of traumatic events during lifetime), and at different moments after the diagnosis. Female gender was an independent predictor of worse mental QOL in patients at T0. Patients and their families should be involved in psychological counselling and psychoeducational interventions, taking into account their differences and the timing of psychological responses, in order to better support them in adjusting to their new life circumstances.

Funding Acknowledgement

Type of funding sources: Public grant(s) – National budget only. Main funding source(s): Regione Autonoma della Sardegna
Clinical impact of “minimal” right ventricular pacing on atrial arrhythmias: results from the prospective multi-center worldwide EMERALD study
Authors: Di Cori A , Taggeselle J , Giaccardi M , Degand B , Bernhardt J , Fazi A , Gonzalez Chana B , Olivier A , Clark R , Bongiorni M G
Published: October 2022

Background/Introduction

Unnecessary right ventricular pacing (RVP), typically the result of pacing forced by the atrio-ventricular delay (AVD), can have deleterious effects such as atrial arrhythmias (AA) and heart failure (HF). Previous studies have shown that these increased risks occur when unnecessary RVP exceeds 40%, leading to the development of pacing modes to reduce the amount of unnecessary RVP and minimize these risks.

Purpose

The EMERALD (AssEssment of CoMorbiditiEs & Atrial ArRhythmiA Burden In DuaL-Chamber PaceD Patients) Study was a real-world registry designed to assess the impact of RVP burden on the risk of developing AA. The primary endpoint was the difference in incidence of persistent/permanent AA in subjects with high (>40%) and low (<40%) RVP.

Methods

EMERALD was a non-interventional, prospective, observational, multi-center registry conducted at 186 centers in 12 countries. The study enrolled subjects without a previous history of persistent or permanent AA implanted with a dual-chamber (DR) pacemaker according to ESC or ACC/AHA/HRS guidelines. Devices could be implanted as de-novo therapy, generator replacement or an upgrade in therapy. All implanted devices were approved for commercial use by local regulatory authorities. Programming was left to the investigators' discretion. Subjects were followed for at least 24 months. Persistent/permanent AA was defined as: a) >22 hours/day of AA for >7 consecutive days; b) permanent/persistent AA diagnosed during any follow-up visit; c) an AA-related ablation carried-out; d) a cardioversion performed during any follow-up visit.

Results

Eligible follow-up data were available for n=3477 subjects with a RVP value. The population was nearly evenly split between High RVP (47.7%) and Low RVP (52.3%). In the High RVP group, 11.7% fulfilled at least one criterion for persistent/permanent AA versus 9.1% in the Low RVP group (p=0.006). The primary endpoint was met. A reanalysis of the data was performed first looking at quartiles of %RVP. Based on this, the threshold of RVP was changed from 40% to 1% (High RVP>1%; Low RVP<1%). Using this new RVP threshold, 13.1% of patients in the High RVP group fulfilled at least 1 criterion for persistent/permanent AA versus 3.4% in the Low RVP group (p<0.0001).

Conclusions

The EMERALD Study confirmed the results of previous studies showing that limiting unnecessary RVP to <40% is beneficial in reducing the risk of AA in unselected DR pacemaker patients. Moreover, it showed for the first time that even small amounts of unnecessary RVP (>1%) significantly increases the risk of AAs, underlining the need to target very low RVP with efficient modes to reduce RVP.

Funding Acknowledgement

Type of funding sources: Private company. Main funding source(s): MicroPort CRM (Clamart, France)
The effect of leadless pacing on LV and RV systolic function is not inferior to conventional RV pacing
Authors: Duchenne J , Garweg C , Puvrez A , Mao Y , Ector J , Willems R , Voigt J U
Published: October 2022

Introduction

Leadless right ventricular (RV) pacing has been recently proposed as alternative to conventional pacemakers (PM's). While RV pacing with a conventional PM is known to cause deterioration of left ventricular (LV) and RV systolic function over time, the effects of leadless PM's are currently under-explored. In this prospective and randomized study, we hypothesized that the effect of leadless RV pacing over time on both LV and RV systolic function is not inferior to conventional RV pacing.

Methods

Fifty-one age-matched patients with a guideline indication for a PM were prospectively recruited and randomized to undergo implantation of either (i) a leadless PM, or (ii) a conventional PM. Patients underwent echocardiography prior to (BL), and at 6 and 12 months (M6 & M12) after PM implantation. All imaging after implantation was performed during active pacing. Analysis included LV ejection fraction (LVEF), LV global longitudinal strain (GLS), and RV free wall (FW) strain.

Results

Twenty-seven patients were implanted with a leadless PM, while twenty-four received a conventional PM. Median age was 82 (80–87) years. At BL, average LVEF and LV GLS were normal and similar in both groups. At M12, both LVEF (−12%) and LV GLS strain (−5%) decreased significantly in both study groups (ANOVA p<0.0001, see Figure 1). RV FW strain decreased only significantly in patients with conventional PM (−4%; ANOVA p=0.031, see Figure 1; post-hoc test BL vs. M12: p=0.029). None of the tested variables, at none of the time points, showed significant difference between the leadless and conventional PM study groups (all p>0.05). Median pacing percentage was 68.2% and similar in both study groups (at all time-points p>0.05).

Conclusions

Both patients with leadless and conventional PM's demonstrate a decrease in LV and RV systolic function, 12 months after implantation. While LV function decrease was similar between both groups, RV function decrease was most prominent in patients treated with conventional PM's. Our data suggest that leadless pacing is not inferior to conventional pacing with regard to the effect on cardiac function.

Funding Acknowledgement

Type of funding sources: Foundation. Main funding source(s): Research Foundation Flanders (FWO) post-doc grant
Emergency pacemaker implantation in nonagenarians with complete heart block: is single chamber pacing sufficient?
Authors: Mahtani K , Parker M , Maclean E , Vyas R , Bo Wang R , Roelas M , Zemrak F , Muthumala A , Moore P , Sporton S , Chow A , Monkhouse C
Published: October 2022

Background

In ambulatory patients with complete heart block and preserved sinus node activity (CHBs), dual chamber pacing confers well-established physiological benefits versus single chamber pacing. There is limited evidence as to whether these benefits extend to very frail patients, especially those over 90 years of age.

Purpose

In nonagenarians presenting with emergent CHBs from 2016–2019, we compared the clinical characteristics of patients selected for single versus dual chamber pacemakers (PPM), and evaluated the symptomatic and prognostic implications of these devices.

Methods

Baseline characteristics were discerned from electronic records, and physiological data extracted from serial PPM interrogations. Frailty was quantified according to the Rockwood clinical frailty scale (1–9). Cause of death was provided by the patients' General Practitioner. Cox proportional hazards analysis (HR, 95% CI) examined associations with all-cause mortality and death from congestive cardiac failure (CCF).

Results

168 consecutive patients were included (44.3% Male, Median age: 91 (2) years) and followed-up for 26.9±14.6 months. 22 patients (13.1%) were implanted with single chamber pacemakers (all programmed VVIR); when compared with patients receiving dual chamber devices, these patients had similar median age (93 (3) versus 91 (2) years, p=0.15) and LV systolic function (LVEF: 49.2% ±9.7 versus 50.7% ±10.1, p=0.71), but were more frail (Rockwood scale: 5.2±1.8 versus 4.3±1.1, p=0.004) and more likely to have severe cognitive impairment (27.3% versus 9.2%, p=0.018). Post implant, patients who received single chamber devices had higher average respiratory rates (21.3±2.4 breaths per minute versus 17.5±2.6 breaths per minute, p=0.002), lower average heart rates (65.5±10.1 bpm versus 71.9±8.6 bpm, p=0.002), and lower daily activity levels (0.57±0.3 hours of activity versus 1.5±1.1 hours of activity, p=0.016) than those with dual chamber devices. Death from CCF was more common in patients receiving single chamber devices (40.9% versus 6.2%, log rank p<0.0001); this association persisted when adjusting for age, frailty and cognitive impairment (adjusted HR: 6.2 (2.2–17.3, p=0.0005). However, in this age group, single chamber pacing was not independently associated with all-cause mortality when compared with dual chamber pacing (adjusted HR: 1.9 (0.95–3.6, p=0.07).

Conclusions

In nonagenarians with CHBs, dual chamber pacing was associated with improved symptomatic outcomes and a reduced risk of death from CCF, but did not affect all-cause mortality when compared with single chamber pacing.

Funding Acknowledgement

Type of funding sources: None.
Chronic outcomes of leadless vs transvenous single chamber ventricular pacemakers in high-risk subgroups
Authors: Boveda S , Higuera L , Longacre C , Wolff C , Wherry K , Stromberg K , Hinnenthal J , Bockstedt L , El-Chami M
Published: October 2022

Background

The Micra leadless pacemaker (LP-VVI) has been shown to have lower chronic complications and device-related reinterventions compared to transvenous ventricular pacemakers (TV-VVI) in a large, real-world population. This study compares the complication and reintervention rate in subgroups with comorbidities associated with higher risk of pacemaker complications and hypothesized to benefit from leadless pacing.

Methods

The longitudinal Micra Coverage with Evidence Development (CED) Study compared the outcomes of Medicare patients receiving LP-VVI to those receiving a TV-VVI in the US. Patients in the Micra CED study were included in this study if they had a diagnosis of chronic kidney disease Stages 4–5 (CKD45), end-stage renal disease (ESRD), malignancy, diabetes, tricuspid valve disease (TVD), or chronic obstructive pulmonary disease (COPD) on any administrative claim in the 12 months prior to pacemaker implant. A pre-specified set of complications and system reinterventions were identified using the relevant diagnosis and procedure codes. Adjusted and unadjusted Fine-Gray competing risks models were used to compare reinterventions and complications between LP-VVI and TV-VVI patients within each subgroup. All results were adjusted for multiple comparisons using a Bonferroni correction. An ad-hoc comparison of a composite endpoint of select reinterventions (system replacement, removal, revision, and lead reinterventions) and device complications was also conducted.

Results

The sample size of patients in each subgroup ranged from 2,032 patients with ESRD to 11,936 patients with diabetes. The percent of LP-VVI patients in each subgroup ranged from 44.0 in the TVD subgroup to 74.9 in the ESRD subgroup. Compared to patients implanted with a TV-VVI, patients with a LP-VVI with malignancy, diabetes, TVD, and COPD had significantly fewer complications (Table 1; Malignancy, HR 0.68, [0.48–0.95]; Diabetes, HR 0.69, [0.53–0.89]; TVD, HR 0.60 [0.44–0.82]; COPD, HR 0.73, [0.55–0.98]). LP-VVI patients with diabetes, TVD, and COPD also had lower rates of reintervention (Table; Diabetes, HR 0.58, [0.37–0.89]; TVD, HR 0.46 [0.28–0.76]; COPD, HR 0.51, [0.29–0.90]). LP-VVI patients with malignancy, diabetes, TVD, and COPD had lower rates of the combined endpoint of device complications and select reinterventions (Table; Malignancy, HR 0.52, [0.32–0.83]; Diabetes, HR 0.52, [0.35–0.77]; TVD, HR 0.44 [0.28–0.70]; COPD, HR 0.55, [0.34–0.89]).

Conclusions

In a real-world study of US Medicare patients, the leadless pacemaker was associated with lower rates of chronic complications and reinterventions at 2 years compared with TV-VVI pacing in several high-risk subgroups.

Funding Acknowledgement

Type of funding sources: Private company. Main funding source(s): Medtronic
Almost zero-fluoroscopy LBBP-procedure using a 3D-mapping system
Authors: Derndorfer M , Puererfellner H , Martinek M R , Kollias G
Published: October 2022

Introduction

Cardiac device therapy has recently been extended by the option of Conduction System Pacing, CSP (HIS Bundle Pacing, HBP; Left Bundle Branch Area Pacing, LBBAP). Similar to cardiac resynchronization therapy (CRT), complex procedures can result in long fluoroscopy-duration and considerable radiation exposure for the patient and the implanting team. According to the principle ALARA (As Low As Reasonably Achievable), measures should be taken to reduce radiation, wherever possible.

We report the almost fluoroscopy-free implantation of a LBBAP-system using a 3D electroanatomical mapping system (EAMS).

The patient was indicated for a pace & ablate concept due to recurrent, highly symptomatic, persistent atrial fibrillation (AF), a history of mitral valve repair and a severely dilated left atrium. ESC guidelines suggest choosing a RV-lead (indication IIa), alternatively either a CRT system or HBP (both IIb). LBBAP as new option for physiological pacing was chosen in this patient because it usually provides excellent stimulation thresholds and the lead – in contrast to HBP – is distant from Koch's triangle, so that AV-nodal-ablation can be performed safely.

Methods

Surgery was performed under deep sedation. After accessing the cephalic vein, a quick 3D map of relevant structures was acquired (right atrium; coronary sinus; HIS; interventricular septum, IVS). Then a preformed sheath and a stylet-driven pacemaker-lead were advanced. The lead-tip was visualized within the EAMS and maneuvered without fluoroscopy. After approaching the proximal IVS, the implantation site was confirmed by unipolar stimulation and the lead was advanced into the IVS under close monitoring of impedance and signals. Final position was confirmed by sheath-angiography [Fig. 1].

Results

During lead fixation, LBBAP-typical ECG-changes (progression to rSR morphology, fixation beats) could be observed. A left bundle branch potential (poLBB) could be documented. The left ventricular activation time (LVAT) as a marker of rapid LV-excitation was shortened from 108 ms to 68 ms. Thresholds for non-selective and selective LBBP were 3 V @ 1 ms and 0.7 V @ 0.4 ms, with a sensing of 8.7 mV, impedance of 643 ohms and a paced QRS-width of 112 ms [Fig. 2]. An atrial lead was added (history of intermittent sinus rhythm) and a dual-chamber pacemaker was connected. Fluoroscopy was required for lead fixation into the IVS, atrial lead placement as well as for sheath angiography and lead length-optimization. Total fluoroscopy time was 1.13 minutes with a radiation dose of 45.04 μGy m2, procedure time 64 minutes. AVN total ablation was performed the following day without complications.

Conclusions

CSP using a 3D mapping system is simple, facilitates understanding of important anatomical structures and helps to reduce the required radiation dose to a necessary minimum. In individual cases, procedures requiring almost zero-fluoroscopy are possible.

Funding Acknowledgement

Type of funding sources: None.
Safety and effectiveness of His-bundle pacing and left bundle branch pacing (conduction system pacing) as a first option for cardiac pacing – results of a single-center
Authors: Slater C , Camanho L E M , Saad E B , Inacio Jr L A O , Dias L C , Santos G V , Mourilhe-Rocha R
Published: October 2022

Background

Conduction system pacing (CSP) (His bundle pacing and left bundle pacing) is a group of techniques intended to achieve cardiac pacing with a narrow QRS complex through a lead directly inserted in conduction system structures. The safety and effectiveness of this technique are not yet fully understood.

Purpose

To describe the short-term implant findings and safety profile of CSP as a first option after 4 years in a single center.

Methods

In a period of 42 months, 214 patients were submitted to CSP as a first strategy to restore AV synchrony (pacemakers for AV block or sinus node dysfunction) or as a resynchronization (CRT) strategy (for patients with heart failure and bundle branch block). CSP lead was implanted in lieu of a conventional right ventricular lead in pacemaker cases, and in addition or in lieu of a coronary sinus lead, in CRT cases, depending on the technical and anatomical possibilities.

Results

The mean age was 76.7±16.4 years, 65% males. 162 patients implanted a CSP lead for a dual-chamber pacemaker, 3 patients for a single chamber pacemaker, 32 patients for CRT-D (CSP lead replacing the coronary sinus lead with a defibrillator), and 13 patients for an optimized CRT (CSP lead plus coronary sinus lead). In 16 patients (7.4%) the technique of choice was His bundle pacing, two of them presented with subacute elevated thresholds, requiring new lead implantation at the moment of generator pulse replacement. One patient submitted to left bundle branch pacing (0.4%) had subacute lead dislodgement, being submitted to lead revision. Four patients intended for CRT (1.8%) didn't meet the criteria for His bundle pacing or left bundle branch pacing, being submitted to conventional coronary sinus lead placement. There were 10 cases (4.6%) of confirmed lead perforation during the lead septum insertion, with prompt repositioning, all uneventful. No pericardium effusion related to lead perforation was observed. One patient (0.4%) had a pneumothorax, requiring chest tube drainage.

Conclusion

Conduction system pacing as a first strategy is a feasible, effective and safe technique, both for pacing and for resynchronization purposes, with a complication rate comparable to conventional implantation.

Funding Acknowledgement

Type of funding sources: None.
Effects of hyperbaric exposure on mechanical and electronic parameters of implantable cardioverter-defibrillators
Authors: Guenneugues R , Henckes A , Mansourati V , Mansourati J
Published: October 2022

Aims

There is currently no adequate assessment of the mechanical and electronic alterations of implantable cardioverter-defibrillators (ICD) in hyperbaric conditions. As a result, many patients eligible for hyperbaric oxygen therapy cannot receive it if they are carrying an ICD, even in emergency situations. Hyperbaric oxygen therapy (HBOT) is the standard adjuvant treatment for life-threatening or disabling pathologies.

Methods

Twenty-two explanted ICDs of various brands and models were randomized in 2 groups: single hyperbaric exposure at an absolute pressure of 4,000 hPa and 30 iterative hyperbaric exposures at an absolute pressure of 4,000 hPa. Mechanical and electronic parameters of these ICDs were blindly assessed before, during and after hyperbaric exposures.

Results

Regardless of the hyperbaric exposure, we could not find any mechanical distorsion, inappropriate occurrence of tachytherapies, dysfunction of tachyarrhythmias therapeutic programming, or dysfunction of programmed parameters.

Conclusion

Dry hyperbaric exposure seems harmless on ICDs tested ex-vivo. This result may lead to a reassessment of the absolute contraindication of emergency HBOT to patients carrying an ICD. A real-life study in patients with ICD receiving HBOT should be performed to assess their tolerance to the treatment.

Funding Acknowledgement

Type of funding sources: None.
Utilization and in-hospital complications associated with implantation of dual versus single chamber implantable cardioverter defibrillator for primary prevention of sudden cardiac death
Authors: Margolis G , Elbaz Greener G , Kazatzker M , Meisel S , Kleiner Shochat M , Heist E K , Ruskin J , Amir O , Roguin A , Rozen G
Published: October 2022

Introduction

Multiple studies showed no clinical benefit in implantation of a dual compared to a single chamber implantable cardioverter defibrillator (dICD vs. sICD) for primary prevention of sudden cardiac death (SCD), in patients with no pacing indication. We aimed to investigate the extent of utilization and complications in sICD vs. dICD implantations in the US, using the National In-Patient Sample (NIS) database.

Methods

Using the NIS database, we identified patients who underwent an elective ICD implantation in the US between 2015 (last quarter)-2019. Patients who had concurrent conduction disorders or indication for atrial pacing were excluded. Baseline demographics, clinical characteristics, cardiomyopathy etiologies as well as outcomes including in-hospital complications, length of stay and mortality were collected. Multivariable logistic regression models were used to identify predictors of complications.

Results and discussion

An estimated total of 15940 patients, who underwent elective ICD implantation for primary prevention of SCD were identified, 8860 (55.6%) of them received a dICD. Forty percent of patients had ischemic cardiomyopathy. The mean age was 64 years and 66% were males. The complication rates documented in the dICD and sICD groups were 13% and 11%, respectively (p<0.001),driven by increased rate of pneumothorax (4.8% vs 3.2%, p<0.001) and lead dislodgement (3.6% vs 2.3%, p<0.001, Table 1). Multivariate analysis confirmed adding an atrial lead as an independent risk factor for “any complication” during ICD implantation [OR 1.13 (1.02–1.25), p=0.022] as well as for pneumo/hemothorax [OR 1.21 (1.03–1.44), p=0.025] and lead dislodgement [OR 1.41 (1.16–1.72), p<0.001].

Conclusion

Despite significant evidence for lack of clinical benefit in adding an atrial lead to a primary prevention ICD implantation, significant proportion of the patients in the US are implanted with a dICD. We show increased risk for complications for dICD compared with sICD implantation in the US in recent years, driven by higher incidence of pneumo/hemothorax and lead dislodgement.

Funding Acknowledgement

Type of funding sources: None.
Intermuscular technique for implantation of the subcutaneous implantable defibrillator: a propensity-matched case-control study
Authors: Botto G L , Ziacchi M , Nigro G , D'Onofrio A , Dello Russo A , Francia P , Viani S , Pisano' E , Bisignani G , Caravati F , Migliore F , De Filippo P , Ottaviano L , Valsecchi S , Checchi L
Published: October 2022

Background

A previous randomized study (PRAETORIAN) demonstrated that the subcutaneous implantable cardioverter–defibrillator (S-ICD) was noninferior to transvenous ICD with respect to device-related complications and inappropriate shocks. However, that was performed prior to the widespread adoption of pulse generator implantation in the intermuscular (IM) space instead of the traditional subcutaneous (SC) pocket.

Purpose

To compare survival from device-related complications and inappropriate shocks between patients who underwent S-ICD implantation with the generator positioned in an IM position in comparison with a SC pocket.

Methods

We analyzed 1577 consecutive patients who had undergone S-ICD implantation from 2013 to 2021 and were followed up until December 2021. SC patients were propensity-matched with patients of the IM group, and their outcomes were compared.

Results

SC implantations were performed in 367 (23%) patients. These patients were propensity-matched with 367 IM patients. Intra-procedural complications were reported in 9 (2.5%) patients in the SC Group and 7 (1.9%) in the IM Group. During a median follow-up of 29 months, device-related complications were reported in 55 (7.5%) patients and inappropriate shocks were reported in 54 (7.4%) patients. The risk of the composite primary endpoint was lower in the matched IM Group than in the SC Group (unadjusted hazard ratio 0.67, 95% CI 0.45–0.99, p=0.042), while the risk of appropriate shocks was similar between groups (unadjusted hazard ratio 0.99, 95% CI 0.60–1.64, p=0.976). There was no significant interaction between generator positioning and variables such as gender, age, body mass index, ejection fraction and generation of the device.

Conclusions

In this experience, IM S-ICD generator positioning was superior to SC positioning in reducing device-related complications and inappropriate shocks.

Funding Acknowledgement

Type of funding sources: None.