bluuebunny/crossref_metadata_2025 huggingface dataset:
Intra-procedural three-dimensional rotational angiography in cryoballoon ablation of atrial fibrillation - a randomised clinical trial
Authors: Prepolec I , Pasara V , Pezo-Nikolic B , Puljevic M , Puljevic D , Milicic D , Velagic V
Published: May 2022

Funding Acknowledgements

Type of funding sources: None.

Introduction

To facilitate atrial fibrillation (AF) ablation procedures there is a variety of approaches for pre-procedural imaging of pulmonary veins (PV) and left atrium (LA), including CT angiography and cardiac MRI. Intra-procedural three-dimensional rotational angiography (3DRA) is the least employed method and it can be advantageous regarding efficiency and procedural logistics. Data supporting different practices is still evolving and there is an open question whether LA imaging could improve safety and outcomes of CB ablation.

Purpose

The aim of this study is to evaluate possible benefits of 3DRA for procedural success, safety and long-term outcomes of CB ablation.

Methods

We designed a single-centre unblinded randomised clinical trial and recruited 101 patients (65.3% male, 59.3±11.5 years) with paroxysmal (92%) and early-persistent AF. Patients were randomized to no imaging or 3DRA which was performed intra-procedurally after trans-septal puncture. Angiographic images were segmented and overlaid to the fluoroscopy screen to guide the ablation procedure. All patients are followed for 1 year and data concerning procedural characteristics, safety outcomes and AF recurrence are being collected.

Results

Of all the patients recruited, 48 (47%) underwent 3DRA. In patients who received no imaging (non-3DRA group) one PV couldn’t be isolated while in 3DRA group isolation of one PV could not be achieved in 3 patients (OR 3.47, 95% CI 0.35-34.51). The occurrence of left common PV, an anatomical variation that could have potential to influence results, was similar in both groups (25,4% in non-3DRA and 25.0% in 3DRA group). Procedure time was significantly longer when 3DRA was performed (87.4±27.7 min compared to 69.9±23.0 in non-3DRA group, p<0.001). Total radiation dose (148.2±177.7 vs 387.7±203.8 mGy, p<0.001) and contrast administration (42.5±27.1 vs 133.8±26.8 ml, p<0.001) were significantly lower in the control group. Only minor complications were reported in both groups. Three patients developed large haematoma (2 in 3DRA group vs 1 in control group). In each group there was one incident of transient phrenic nerve palsy.

Conclusion

3DRA is a safe and efficient intra-procedural imaging method to guide CB ablation for AF. However, it significantly increases procedure duration, total radiation dose and contrast expenditure. In our trial it did not have any impact on the acute success rate of PV isolation. One-year follow up data is still being collected and will subsequently be presented.
Characterization of high-power and very-high-power short-duration radiofrequency lesions performed with a new-generation catheter and a temperature-control ablation mode
Authors: Lozano-Granero C , Moreno Planas J , Matia-Frances R , Hernandez-Madrid A , Sanchez-Perez I , Zamorano Gomez JL , Franco-Diez E
Published: May 2022

Funding Acknowledgements

Type of funding sources: None.

Introduction

High-power short-duration (HP-SD) and very high-power short-duration (VHP-SD) has recently emerged as an alternative ablation strategy to shorten application times while maintaining or improving the effectiveness and safety of atrial fibrillation ablation (1 - 2). Although usually performed with standard irrigated-tip catheters in a power-controlled mode, a novel dedicated catheter with a multi-thermocouple system capable of real-time temperature monitoring and optimized for temperature-controlled ablation by power and irrigation rate modulation has been developed for this scenario (3 - 4).

Purpose

We conducted an experimental ex-vivo study to analyse the differences between radiofrequency lesions obtained with this novel catheter (QDOT MICRO®) using HP-SD and VHP-SD. Besides, we also aim to compare them to HP-SD lesions obtained with a standard non-dedicated catheter (THERMOCOOL SMARTTOUCH®) and to conventional-powered lesions performed with either catheter.

Methods

280 epicardial radiofrequency applications were performed on porcine left ventricle submerged in 37ºC saline: 40 VHP-SD (90W) with QDOT MICRO (4 sets of 10 using a contact force (CF) of 10 and 20 grams and an application time of 3 and 4 seconds); 80 HP-SD lesions (50W), 40 of them with QDOT MICRO and 40 of them with THERMOCOOL SMARTTOUCH (4 sets of 10 lesions using a CF of 10 and 20 and an ablation index (AI) of 400 and 550 with each catheter) and 160 conventional-power lesions (35 and 40W), 80 of them with QDOT MICRO and 80 of them with THERMOCOOL SMARTTOUCH (4 sets of 10 lesions using a CF of 10 and 20 and an AI of 400 and 550 for each catheter and power setting). After each application, lesions were cross-sectioned and measured. Volume vas calculated using a validated formula (5).

Results

In an intracatheter analysis, HP-SD lesions were bigger than VHP-SD ones, both when using parameters intended for posterior wall ablation (AI 400 in HP-SD or 3 seconds in VHP-SD), 98.1±11.7 vs 36.8±8.5 mm3, p<0.0001 with 10g CF, and 106.7±8.1 vs 52.3±9.8 mm3, p<0.0001 with 20g CF; and when using parameters intended for anterior wall ablation (AI 550 in HP-SD or 4 seconds in VHP-SD), 227.6±25.1 vs 61.0±7.8 mm3, p<0.0001 with 10g CF, and 186.6±23.3 vs 72.2±5.0 mm3, p<0.0001 with 20g CF (see figure).

In an intercatheter analysis, conventional as well as HP-SD lesions were generally smaller with THERMOCOOL SMARTTOUCH than with QDOT MICRO, although less difference could be found when applying a CF of 20g instead of 10g (see figure and table).

Conclusions

VHP-SD lesions are smaller than HP-SD ones, which would allow for a safer and faster ablation. However, a HP-SD strategy would be preferable over VHP-SD if greater lesion volume is desirable.
Durability of pulmonary vein isolation following cryoballoon ablation: lessons from a large series of repeat ablation procedures
Authors: Mugnai G , Cecchini F , Stroker E , Sieira J , Bolzan B , Tomasi L , Brugada P , De Asmundis C , Chierchia GB
Published: May 2022

Funding Acknowledgements

Type of funding sources: None.

Background

The cryoballoon technology has been widely proven to be effective in achieving acute pulmonary vein (PV) isolation and favorable clinical outcome. To date, little information is still available about occurrence of late PV reconnection after cryoballoon ablation.

Purpose

To assess the rate of durable PV isolation following cryoballoon ablation of atrial fibrillation in the setting of repeat procedures.

Methods and Results

A total of 154 consecutive patients (90 male, 58.4%; mean age 60.6±12.6 years) underwent a repeat procedure, after a mean 21.5±12.4 months (median 14 months), after index ablation using the 28-mm second-generation cryoballoon. All repeat ablations were performed using a 3-dimensional electro-anatomical mapping system. Among all 590 PVs, including 26 left common ostiums (LCOs), 99 (16.8%) showed a PV reconnection in 86 patients (1.15 per patient). Persistent PV isolation could be documented in 491 of 590 PVs (83.2%). In 68 of 154 patients (44%), all PVs were electrically isolated. In the multivariable analysis, balloon nadir temperature (p<0.01) and time to PV isolation (P=0.02) independently predicted late PV reconnection.

Conclusions

The rate of late PV reconnection after second-generation cryoballoon ablation was low (1.15 PVs/patient). Globally, the rate of durable PV isolation assessed during repeat procedures was 83.2%. The balloon nadir temperature and faster time to isolation were independently associated with durable PV isolation.
Early results of the novel radiofrequency balloon ablation catheter for pulmonary vein isolation
Authors: Breitenstein A , Kanthasamy V , Hofer D , Hunter R , Butcher CH , Ahluwalia N , Schilling RJ , Finlay M
Published: May 2022

Funding Acknowledgements

Type of funding sources: None.

Background

Pulmonary vein isolation (PVI) remains the cornerstone for treating of symptomatic atrial fibrillation (AF). Single-shot PVI technologies have evolved as a standard for first-time PVI. A novel radiofrequency balloon ablation catheter is now available to offer single-shot RF pulmonary vein isolation.

Purpose

To summarize the early experience using the novel RF balloon ablation catheter for patients undergoing PVI in two tertiary centres in Europe.

Methods

We prospectively assessed the first 38 consecutive patients undergoing PVI using RF balloon ablation catheter for paroxysmal or persistent AF in two high volume centres. Both centres used a standardised approach including ultrasound-guided vascular access, uninterrupted anticoagulation, transeptal puncture via the RF balloon sheath and a limited 3D mapping software-guided LA geometry created with a circular mapping catheter. Radiofrequency application for 60s to the anterior segments and 20s posteriorly was performed in all cases, phrenic pacing was employed for ablation of right PVs. BHS performed all procedures (except 2 cases due to high BMI and severe sleep apnea) under sedation, while all patients from UHZ underwent PVI procedures with general anaesthesia as per institutional protocol. All patients had an oesophageal temperature probe to assess oesophageal temperature during ablation (passed orally under sedation) and had uninterrupted oral anticoagulation throughout the periprocedural period.

Results

Overall, mean age was 64±8 years, 23 (61%) were male, 24 (63%) of patients had paroxysmal AF. The majority were de novo interventions (92%). There was no significant difference between the patients demographics in the two hospitals. All veins were isolated in both groups with a total of 144 applications (n = 73 in the sedation group, n = 71 in the GA population). Median fluoroscopy time was comparable (sedation group 1.1 minutes vs GA group 1.2 minutes; P = 0.58), but median procedure time was shorter in the sedation group (65 minute vs 106 minutes; P < 0.001). The median number of RF ablation per patient (sedation group 7 vs GA group 9; P = 0.32) and time to isolation of each vein (sedation group 11 seconds vs GA group 10 seconds; P = 0.9) were similar. Number of acute reconnections requiring further ablations were not significantly different between groups (sedation group 11 [15%] vs GA group 14 [20%]; P = 0.96). One patient sustained transient phrenic nerve injury in the sedation group.

Conclusion

Our early experience shows the novel HS balloon ablation can be performed effectively, efficiently and safely under either GA or conscious sedition. The RF balloon ablation catheter paradigm lends itself to refined workflows, with low fluoroscopy requirements and a short learning curve even in initial cohorts.
Contact force-controlled high power short duration radiofrequency ablation enables efficient creation of roof line and anterior mitral line in course of low voltage areas
Authors: Schreieck J , Seizer P , Duckheim M , Scheckenbach C , Gawaz M , Heinzmann D
Published: May 2022

Funding Acknowledgements

Type of funding sources: None.

Background

Linear ablation lines in the left atrium are questionable for treatment of atrial fibrillation (AF). In particular they are challenging, performed with limited success rate and are arrhythmogenic due to recurrence of conduction. Contact force (CF)-controlled high power short duration (HPSD) radiofrequency ablation (RFA) in areas of fibrosis may overcome these limitations.

Purpose

We investigated the efficiency of contact force (CF)-controlled high power short duration (HPSD) radiofrequency ablation (RFA) for creation of linear lines in case of fibrotic areas in the anterior left atrium.

Methods

In 530 consecutive patients (pts), age 65±9 years, paroxysmal AF in 45%, persistent AF in 55%, AF-re-ablation in 32% of pts, undergoing HPSD CF-controlled RF ablation of AF. Besides from pulmonary vein isolation (PVI) additional left atrial linear ablation in the anterior left atrium was performed in 28% of patients exclusively in case of low voltage areas in the course of the line or in case of re-ablation of prior performed lines. Fibrosis was defined by areas of less than 0.5mV signals in high density 3D microelectrode mapping. More than 5% low voltage was present in 46% of pts and more than 20% low voltage in 27% of pts. HPSD RF ablation was performed using a power of 50 Watt, duration 5-15s, with CF-controlled catheters, seeking for CF of 10-30g, and an interlesion distance of 6mm.

Results

A anterior roof line between both upper pulmonary veins was performed in 25% of pts (n=133), and an anterior mitral line in 17% of pts (n=88). The anterior mitral line connected the superior mitral anulus with left upper, right upper PV or anywhere this the roof line depending on the distribution of low voltage areas. Overall success rate of bidirectional conduction block at the roof line was 92% and at the mitral line 94%. After remapping of gaps and re-ablation with conventional 35-40 Watt RF application of unlimited duration, success rate at the roof line improved to 98% and at the mitral line to 97%. No serious complications were associated with creation of these lines, especially, no pericardial tamponade occurred. Limited follow up will presented at the time of presentation.

Conclusions

CF-controlled creation of ablation lines in the anterior left atrium (roof line and anterior mitral line) by HPSD RF ablation is very efficient and safe in case of areas of low voltage in the course of the linear ablation. In rare cases additional conventional RF application of unlimited duration becomes necessary to complete the lines supported by identification of gaps by high density 3D microelectrode mapping. This approach has the potential to improve efficacy of AF ablation in patients with atrial fibrosis. The hypothesis have to be proven by a prospective controlled study in the near future.
Impact of P-glycoprotein and/or CYP3A4-interacting drugs on the risk-benefit profile of NOACs in patients with atrial fibrillation: a meta-analysis
Authors: Grymonprez M , Vanspranghe K , Capiau A , Boussery K , Steurbaut S , Lahousse L
Published: May 2022

Funding Acknowledgements

Type of funding sources: Public grant(s) – National budget only. Main funding source(s): Research Foundation Flanders (FWO)

Background

P-glycoprotein (P-gp) and CYP3A4-interacting drugs influence plasma levels of non-vitamin K antagonist oral anticoagulants (NOACs). However, the clinical relevance is questioned.

Purpose

A critical appraisal of the impact of pharmacokinetically-interacting drugs on the effectiveness and safety of NOACs in patients with atrial fibrillation (AF).

Methods

After searching Pubmed and Embase, phase III randomized controlled trials (RCTs) and longitudinal observational cohort studies on the impact of concomitantly used P-gp/CYP3A4-interacting drugs on the risk-benefit profile of NOACs in AF patients during a mean/median follow-up of ≥6 months were included. A fixed effects meta-analysis was performed with the Mantel-Haenszel method.

Results

Fifteen studies were included (10 post hoc analyses of RCTs, 5 observational studies), investigating 21,711 and 306,421 NOAC-treated AF patients with and without P-gp/CYP3A4 inhibitor use respectively, while only one study included P-gp/CYP3A4 inducers. In NOAC-treated AF patients, concomitant use of P-gp/CYP3A4 inhibitors was associated with significantly higher major bleeding (relative risk (RR) 1.10, 95% confidence interval (CI) (1.01-1.19)) and all-cause mortality risks (RR 1.14, 95%CI (1.05-1.23)) compared to not using P-gp/CYP3A4 inhibitors, while the risks of stroke/SE (RR 0.88, 95%CI (0.77-1.01)), intracranial bleeding (RR 0.89, 95%CI (0.68-1.15)) and gastro-intestinal bleeding (RR 1.09, 95%CI (0.91-1.30)) were not significantly different. Concomitant use of amiodarone with NOACs was associated with lower thromboembolic (RR 0.75, 95%CI (0.61-0.92)), but higher mortality risks (RR 1.21, 95%CI (1.05-1.39)). Co-administration of verapamil or diltiazem was associated with higher major bleeding risks (RR 1.64, 95%CI (1.31-2.06)), but no significantly different thromboembolic or mortality risks.

Conclusions

Given the higher bleeding and mortality risks in NOAC-treated AF patients concomitantly using P-gp/CYP3A4 inhibitors compared to NOAC users not taking interacting drugs, close monitoring of these patients is warranted, including regular medication review and addressing modifiable bleeding risk factors. Regarding P-gp/CYP3A4 inducers, a considerable research gap was identified, necessitating more research on their impact.
The optimal duration of dual antiplatelet therapy after PCI with drug-eluting stent: a systematic review and Bayesian network meta-analysis
Authors: Mengjin H
Published: May 2022

Funding Acknowledgements

Type of funding sources: None.

Objective

We aimed to test the optimal duration of dual antiplatelet therapy (DAPT) on long-term clinical outcomes after implantation of drug-eluting stents (DES).

Methods

We searched Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, Web of Science through November 8th, 2021 to identify randomized controlled trials (RCT) assessing the duration of DAPT in patients receiving DES. Efficacy of all DAPT strategies was reported as pooled odd ratios (OR) with 95% credible interval (CrI) to summarize the effect of each strategy tested.

Results

We identified 24 RCTs containing 81405 patients. In comparison with 12-month DAPT, 3-month DAPT followed by P2Y12 inhibitor monotherapy could reduce net clinical events (OR: 0.72; CrI: 0.55-0.94) and major bleeding (OR: 0.57; CrI: 0.34-1.00) without increasing ischeamic events (OR: 0.93; CrI: 0.68-1.29). Although >12-month DAPT was associated with a lower risk of myocardial infarction (OR: 0.67; CrI: 0.51-0.93), yet the risk of major bleeding (OR: 1.70; CrI: 1.10-2.70) was also increased, which is more strongly related to all-cause death than ischeamic events. Moreover, the benefits of 3-month DAPT (P2Y12 Inhibitor) were consistent for male patients with acute coronary disease, young age, complex lesion, single vessel disease, low body mass index, without diabetes.

Conclusion

Among patients treated with DES, 3-month DAPT followed by P2Y12 inhibitor monotherapy could reduce the risk of net clinical events without increasing ischeamic events. DAPT beyond one year reduced myocardial infarction at the expense of increased major bleeding. Taken together, 3-month DAPT followed by P2Y12 inhibitor monotherapy may be the optimal strategy for patients receiving DES.
Zero- and minimal fluoroscopic approaches during ablation of supraventricular tachycardias: A systematic review and meta-analysis
Authors: Debreceni D , Janosi K , Vamosi M , Komocsi A , Simor T , Kupo P
Published: May 2022

Funding Acknowledgements

Type of funding sources: None.

Introduction

Catheter ablations for cardiac arrhythmias are conventionally performed under fluoroscopic guidance. Using three dimensional electroanatomical mapping systems to guide these procedures, zero/minimal fluoroscopy (Z/MF) approaches became available.

Purpose

Our aim was to conduct a meta-analysis comparing these two different methods for the treatment of paroxysmal supraventricular tachycardias (SVT).

Methods

Electronic databases were searched and systematically reviewed for studies comparing procedural parameters and outcomes of conventional, fluoroscopy-guided vs. Z/MF approaches in patients undergoing EP procedures for SVTs. The random-effects model was used to derive mean difference (MD) and risk ratios (RR) with 95÷ confidence interval (CI).

Results

24 studies involving 9,074 patients met our inclusion criteria. There were no differences between the groups in acute success (RR=1.00, 95÷ CI, 0.99–1.01; p=0.97) and long-term success rate (RR: 1.01, 95÷ CI, 1.00–1.03; p=0.13). Compared to the conventional method, Z/MF ablation significantly reduced fluoroscopic time (MD: -10.95 min (95÷ CI, -18.43 to -3.46 min; p<0.01)) and ablation time (MD: -25.23 s (95÷ CI: -42.04 to -8.43 s; p<0.01)). Procedure time (MD: 3.06 min (95÷ CI: -0.97 to 7.08; p=0.14)) and number of ablation applications (MD: 0.13 (95÷ CI: -0.86 to 1.11; p=0.80)) were not different between the groups. Complication rate was 1.59% in the entire study population and did not differ among the groups (RR: 0.68, 95÷ CI: 0.45–1.05; p=0.08).

Conclusions

Z/MF approach for the catheter ablation of SVTs is a feasible method that reduces radiation exposure and ablation time but does not compromise the acute and long-term success, or complication rates.
Incidence and clinical characteristics of patients with torsades de pointes complicating acquired atrioventricular block
Authors: Bun S-S , Heme N , Taghji P , Asarisi F , Squara F , Scarlatti D , Moceri P , Deharo JC , Ferrari E
Published: May 2022

Funding Acknowledgements

Type of funding sources: None.

Background

Female gender, degree of QT prolongation and genetic susceptibility are known risk factors for developing torsade de pointe (TdP) during high-degree atrioventricular block (HD-AVB).

Objective

To analyze the incidence and clinical characteristics of patients presenting with TdP and AVB (TdP [+]) in comparison with non-TdP patients with AVB (TdP [-]).

Methods

All the ECG from patients prospectively admitted for advanced AVB (2 to 1 and complete) at our university hospital were analyzed. Automated corrected QT (QTc), and manual measurements of QT and JT intervals, and Tpeak-Tend were performed at the time of most severe bradycardia.

Results

From Sept 2020 to Nov 2021, 100 patients were admitted for HD-AVB. Among them, 17 patients with TdP were identified (8 men; 81 ± 10 years). No differences could be identified concerning automated QTc, manual QTc (Bazett correction), baseline QRS width and mean left ventricular ejection fraction between the two groups. Potassium serum level on admission and mean number of QT-prolongating drugs per patient were not significantly different between the two groups, respectively: 4.34 ± 0.5 in TdP [+] versus 4.52 ± 0.6 mmol/L (p = 0.33); and 0.6 ± 0.7 in group A versus 0.5 ± 0.7 (p = 0.15). In contrast, manual QTcFR (Fridericia correction), corrected JT, Tpeak-to-end and Tpe/QT ratio were significantly increased in the TdP [+] group: respectively 486 ± 70 versus 456 ± 53 ms (p = 0.04); 433 ± 98 versus 381 ± 80 (p = 0.02); 153 ± 57 versus 110 ± 40 (p < 0.001); 0.27 ± 0.08 versus 0.22 ± 0.06 (p < 0.001).

Conclusion

The incidence of TdP complicating acquired AVB was 17 % in a medium-volume center. Longer QTc (Fridericia), corrected JT and Tpeak-to-end were electrocardiographic predictors of TdP, while no clinical characteristics may predict the occurrence of this complication.
Assessing the field of view of multisize electrodes in ischemic cardiomyopathy by validating against ex-vivo high resolution cardiac magnetic resonance
Authors: Omara S , Glashan CA , Tofig BJ , Tao Q , Blom SA , Nielsen JC , Lukac P , Kristiansen SB , Van Der Geest RJ , Zeppenfeld K
Published: May 2022

Funding Acknowledgements

Type of funding sources: Public hospital(s). Main funding source(s): Leiden University Medical Centre

Background

Substrate identification after myocardial infarction (MI) relies on voltage mapping. Early reperfusion results in non-transmural scar (NTS). Narrow-spaced microelectrodes (ME) are thought to have a limited field of view (FOV). The role of ME for delineation of NTS is unclear.

Purpose

To evaluate mapping with multi-size electrodes for identifying NTS, validated against high-resolution ex-vivo cardiac magnetic resonance imaging (HR-LGE-CMR).

Methods

Nine swine with early reperfusion MI underwent endocardial electroanatomical voltage mapping (EAVM) with the QDOT catheter which incorporates three ME in the 3.5mm tip electrode. HR-LGE-CMR (0.3mm slices) were obtained and merged with EAVM. At each EAVM point a transmural cylinder (5mm radius) was projected on the CMR and the volume of viable myocardium (VM) in the cylinder quantified (Otsu method). Unipolar (UV) and bipolar (BV) voltages from conventional (c) and microelectrodes (µ) were related to VM. Cut-off values for normal myocardium were based on 5th percentiles of areas without fibrosis.

Results

In each swine 220 (IQR 216-260) mapping points were collected (total 2322 points). Cut-off for normal myocardium were 3.18 mV, 0.85 mV, 3.28mV and 1.93 mV for UVc, BVc, UVµ and BVµ, respectively. Wall thickness (WT) was reduced in areas with fibrosis vs. no fibrosis (5.4mm, IQR 3.2- 6.9 vs. 7.4mm, IQR 5.3 - 9.6). All voltages were reduced at sites with fibrosis vs. no fibrosis (UVs 4.4mV vs. 6.8mV; BVc 1.2mV vs. 2.1mV; UVµ 2.5mV vs. 5.5mV, and BVµ 2.9mV vs. 5.4mV, all p<0.001).

For areas with any fibrosis, all voltages increased with increasing WT up to the maximal WT of 13mm (fig. 1). Similarly, all voltages increased with an increase in VM volumes from >200mm3 to >600 mm3 (equivalent to a cylinder with h=7.64mm) (fig. 2) with the strongest correlation for UVµ (r=0.47). Below a volume of 200mm3 VM voltages did not correlate significantly with VM.

Conclusion

In NTS, UVc, BVc, and, notably, BVµ and UVµ increase with increasing WT and increasing transmural volume of VM, with the biggest role perhaps laid out for UVµ to estimate transmural VM. EAVM cannot accurately delineate areas with the lowest amount of VM, potentially due to insufficient far field cancellation in NTS. Both these findings argue against a limited FOV of ME.
Multimodality planning of stereotactic radio-ablation for ventricular tachycardia. Results from the international MUSIC consortium
Authors: Cochet H , Tedrow U , Maury P , Whitaker J , Woods C , Gandjbakhch E , Khalifa J , Bredfeldt J , Mak R , Sauer W , Sermesant M , Sacher F , Bogun F , Jais P , Zei P
Published: May 2022

Funding Acknowledgements

Type of funding sources: Public grant(s) – EU funding. Main funding source(s): European Research Council

Background

Optimal SBRT planning methods for VT ablation are yet to be defined.

Purpose

To evaluate a multimodal approach for SBRT planning.

Methods

30 pts (age 70±10, 90% men, LVEF 26±9%, 67% ICM, 47% NICM or mixed, 1.7±1.2 prior catheter ablations) with drug-refractory VT underwent imaging prior to SBRT. The inHEART technology was used to create image-based 3D models of substrate, cardiac anatomy, and organs at risk (coronaries, phrenic nerve, GI tract, AV node). In MUSIC software (IHU Liryc-Inria), 3D models were fused with prior EP maps, and SBRT targets were interactively drawn in 3D by the referring EP cardiologist. Transmural target volumes and organs at risk were fused with a 4D planning CT and used to plan SBRT in Eclipse (Varian).

Results

SBRT was delivered on median PTVs of 96[63-149] mL (total dose 25 Gy) with either Truebeam or Edge systems (Varian). Over a median FU of 4[2-8] months, death occurred in 11(37%) pts, due to arrhythmia recurrence in 4(13%). FU at 6 months was available in 14 pts. In these, the median numbers of VT episodes and ICD shocks over the 6 months preceding SBRT were 20[9-27] and 8[5-15], respectively. In the 6 months following SBRT, these decreased to 0[0-30] and 0[0-0], respectively (P<0.001 for both). 8/14(57%) pts were free from any VT recurrence, and 11/14(79%) were free from any ICD shock. In the total cohort, complications attributed to SBRT were observed in 2/30 (7%), none of which were fatal (heart failure and pneumonitis, both managed with steroids).

Conclusion

In patients with severe drug- and catheter ablation-refractory VT, SBRT planning based on 3D image-based models fused with prior EP maps is feasible, and associated with favorable efficacy and safety profiles.
Myocardial fibrosis predicts ventricular arrhythmias and sudden death after cardiac electronic device implantation
Authors: Zegard A , Okafor O , Foley P , Umar F , Taylor R , Marshall H , Stegemann B , Moody W , Steeds R , Halliday B , Hammersley D , Jones R , Prasad S , Qiu T , Leyva F
Published: May 2022

Funding Acknowledgements

Type of funding sources: Private grant(s) and/or Sponsorship. Main funding source(s): Unrestricted educational grants

Background

Increasing evidence supports a link between myocardial fibrosis (MF) and ventricular arrhythmias. We sought to determine whether presence of MF on visual assessment (MFVA) and gray zone fibrosis (GZF) mass predicts SCD and ventricular fibrillation / sustained ventricular tachycardia after cardiac implantable electronic device (CIED) implantation.

Methods

In this prospective study, total fibrosis and GZF mass, quantified using cardiovascular magnetic resonance, was assessed in relation to the primary endpoint of sudden cardiac death (SCD) and the secondary, arrhythmic endpoint of SCD or ventricular arrhythmias after CIED implantation.

Results

Among 700 patients (age 68.0 ± 12.0yrs [mean ± SD]), 27 (3.85%) experienced a SCD and 121 (17.3%) met the arrhythmic endpoint over 6.93 yrs (median; interquartile range 5.82-9.32). MFVA predicted SCD (hazard ratio [HR]: HR:26.3 [95% confidence interval [CI] 3.70-3337]; negative predictive value: 100%). In competing risks analyses, MFVA also predicted the arrhythmic endpoint (subdistribution [sHR]: 19.9 [95% CI 6.40-61.9]; negative predictive value:98.6%). Compared with no MFVA, a GZF mass measured with the 5SD method (GZF5SD) > 17 g was associated with highest risk of SCD (HR: 44.6;95% CI 6.12-5685) and the arrhythmic endpoint (sHR: 30.3 [95% CI 9.60-95.8]). Adding GZF5SD mass to MFVA led to reclassification of 39% for SCD and 50.2% for the arrhythmic endpoint. In contrast, LVEF did not predict either endpoint.

Conclusions

In CIED recipients, MFVA excluded patients at risk of SCD and virtually excluded ventricular arrhythmias. Quantified GZF5SD mass added predictive value in relation to SCD and the arrhythmic endpoint.
Prevention of early sudden cardiac death after myocardial infarction using the wearable cardioverter defibrillator - results from a real-life cohort
Authors: Rohrer U , Manninger M , Odeneg T , Ebner C , Moertl D , Keller H , Dirninger A , Stix G , Alber H , Steinwender C , Binder R , Stuehlinger M , Zweiker D , Zirlik A , Scherr D
Published: May 2022

Funding Acknowledgements

Type of funding sources: None.

Background

Patients are at elevated risk of sudden cardiac death (SCD) after acute myocardial infarction (MI). The VEST trial failed to show a significant reduction in arrhythmic mortality in patients prescribed with a wearable converter-defibrillator (WCD), having a lower than expected wearing compliance. We aimed to investigate the incidence of WCD treatments and outcomes of all patients with acute MI and LVEF ≤35% in a real life and well-compliant cohort in Austria.

Methods

We performed a retrospective analysis of all patients meeting the in- and exclusion criteria of the original VEST trial within the Austrian WCD registry between 2010 and 2021.

Results

105/896 patients (12%) with an average age of 64±11 years (12% female; LVEF 28±6%) registered in the Austrian WCD registry met the VEST in- and exclusion criteria. 104/105 patients were revascularized and prescribed with a WCD prescription for 69 (1;277) days, the median wearing duration was 23.5 (0;24) hours/day. 4/105 (3.8%) patients received 9 appropriate WCD shocks, the per patient shock rate was 2 (1;5). No inappropriate shock was delivered. During follow-up, 46/105 patients (44%) received an ICD after the WCD period, 4/105 (3.8%) patients died during follow-up. Arrhythmic mortality (1.9% Austria vs. 1.6% VEST, p=ns), as well as all-cause mortality (3.8% vs. 3.1%, p=ns) in the Austrian cohort were comparable to the VEST cohort.

Conclusion

The WCD is a safe treatment option in a highly selected cohort of patients with a LVEF ≤35% after acute myocardial infarction. However, despite excellent WCD compliance as opposed to the VEST study, only 3.8% of patients receive appropriate WCD shocks and the arrhythmic mortality rate was not significantly improved.
Programmed ventricular stimulation for risk stratification in patients with myocardial scarring and an ejection fraction above or equal to 40%
Authors: Soris A , Herrera-Siklody C , Lebloa M , Domenichini G , Teres C , Porretta A , Haddad C , Pruvot E , Pascale P
Published: May 2022

Funding Acknowledgements

Type of funding sources: None.

Background

Sudden cardiac death (SCD) is one of the leading causes of death, particularly among patients with myocardial scars. Implantable cardioverter defibrillators (ICD) are recommended in patients with a left ventricular ejection fraction (LVEF) ≤ 35%. Another recognised indication is the induction of sustained ventricular tachycardia (VT) or ventricular fibrillation (VF) during programmed ventricular stimulation (PVS) in post-myocardial infarction patients with non-sustained VT and a LVEF between 35% and 40%. However, no recommendation exists to guide the use of prophylactic ICD implantation in patients with less altered LVEF, even though they represent the majority of SCDs.

Purpose

We aimed to evaluate the prognostic value of PVS in patients with myocardial scars and a relatively preserved LVEF (≥ 40%).

Methods

Patients with evidence of a chronic myocardial scar and a LVEF ≥ 40%, who underwent PVS at two hospital centers were considered for inclusion. Ischemic and non-ischemic myocardial scars were included. The primary endpoint was the occurrence of a Major Arrhythmic Event (MAE), namely SCD, clinical VT/ventricular fibrillation, or appropriate ICD therapy.

Results

134 patients were included (mean age 62.4 ± 12.5 years, LVEF 54.7 ± 8.6 %). Indication for PVS was mostly non-sustained VT and/or syncope (84%). Post-myocardial infarction patients represented about half of the cases (53%). Inducibility during PVS was observed in 17 patients (13%). There was a nonsignificant trend towards higher inducibility rates in ischemic versus nonischemic scars (17% and 8%, respectively; p-value = 0.1). Of these patients, 15 received an ICD (88%). Over a mean follow-up of 49 (±42) months, a MAE occurred in 7 patients (41.2%) with positive PVS, versus 4 patients (3.4%) with negative PVS. MAE-free survival at 10 years was 91% and 43% in PVS-negative and PVS-positive patients, respectively (p-value < 0.001). One SCD occurred in a PVS-positive patient who denied prophylactic ICD implantation. Inducibility during PVS provided a 64% sensitivity and a 97% negative predictive value (PV) to predict the occurrence of MAE (specificity 92%, positive PV 41%).

Conclusion

PVS is a useful tool to discriminate patients with myocardial scars and LVEF ≥ 40% at increased arrhythmic risk. Effective utilisation of ICD may be anticipated in case of positive PVS, while non-inducible patients are at lower MAE risk.
Permanent his bundle pacing in suprahisian versus infrahisian atrioventricular block . A single center experience
Authors: Pestrea CG , Gherghina AI , Ortan FO
Published: May 2022

Funding Acknowledgements

Type of funding sources: None.

Introduction

Permanent His bundle pacing is currently considered the most physiological form of cardiac pacing. The main benefit of the procedure, compared to right ventricular pacing, is encountered in atrioventricular block, where a high burden of ventricular pacing is expected. One of the limits of His bundle pacing is a distal conduction abnormality in the His-Purkinje system. Nevertheless, there is published data that shows the possibility of conduction system capture even in these patients. This retrospective study evaluated the feasibility of permanent His bundle pacing in patients with second or third degree AV block, taking into account the level of block : suprahisian vs. infrahisian.

Material and methods

45 patients with second or third degree AV block with an attempt at permanent His bundle pacing and an available intraprocedural hisian electrogram for review were included. The procedure went as follows: a lead delivery system including a preformed 3D shaped sheath and a lumenless lead with a fixed exposed helix was placed at the septal atrioventricular junction. Careful mapping was performed until a His bundle signal was recorded. At that site, the pacing response was evaluated at variable pacing outputs. The procedural criteria for success was conduction system capture (selective or non-selective) with an amplitude of less than 2,5V/1ms. If the criteria was met, the lead was fixed, an atrial lead was placed and both connected to a dual-chamber pacemaker. The periprocedural characteristics and those at the three-months follow-up were noted.

Results

28 patients (62,2%) were diagnosed with suprahisian block, with a procedural success rate of 89 % and 17 (37,8%) with infrahisian block, with a procedural success rate of 59%. QRS duration was 96,4±21,6 ms in those with suprahisian block vs. 119,4±23,8 ms in those with infrahisian block (p=0,0027). There was no significant statistical difference regarding acute His bundle pacing thresholds (1,13±0,63 V/1ms vs. 1,25±0,76 V/1ms, p= 0,66), ventricular sensing (3,46±1,5 mV vs. 3,21±1,6 mV, p= 0,68) and fluoroscopy time (12,75±8,3 min vs. 10,78±9,5 min, p= 0,57) between suprahisian and infrahisian block. Also, the paced QRS duration was similar between the two groups (86,9±13,4 ms vs. 82±14,7 ms, p= 0,38) and narrower than the baseline complex. The three-months follow-up showed stable pacing and sensing parameters, without other procedural or lead related complications.

Conclusions

In atrioventricular block, permanent His bundle pacing achieves atrioventricular resynchronization, while maintaining rapid and synchronous biventricular depolarization. As expected, in suprahisian blocks the success rate is superior to infrahisian blocks. Nevertheless, in a significant proportion of the latter cases, His bundle pacing can recrute the intrinsic conduction system.
Tricuspid valve complications during leadless pacemaker implantation
Authors: Hauser R , Casey S , Sengupta J
Published: May 2022

Funding Acknowledgements

Type of funding sources: Foundation. Main funding source(s): Minneapolis Heart Institute Foundation

Background

The implantation of a leadless right ventricular pacemaker (LPM) may be complicated by tricuspid valve injury or interference with tricuspid valve function.

Purpose

Characterize the nature, causes, and outcomes of tricuspid valve injury and functional interference due to LPM implantation.

Methods

The Food and Drug Administration’s Manufacturers and User Facility Device Experience (MAUDE) database was queried for tricuspid valve adverse events involving the Medtronic Micra LPM that were reported by the manufacturer.

Results

From 2016-October 2021, 19 patients suffered a tricuspid valve adverse event, including damage to the leaflets, papillary muscle, or chordae tendineae (n=14; 74%); interference with valve closure (n=3; 16%); and 2 LPMs were irretrievably wedged in the tricuspid valve apparatus. Damaged valves included: 1) torn leaflet or chordal tissue found in the delivery system (n=6) after complicated or failed LPM recapture that necessitated removal without the LPM retracted into the delivery system; all patients developed tricuspid regurgitation, and one patient died. 2) valve damage by the delivery system either directly (n=6) or during LPM recapture (n=1) or removal by a snare (n=1); all patients had new or worsening tricuspid regurgitation; one patient died, 2 had valve repair, and one valve was replaced. In three patients the LPM interfered with valve closure; one patient had valve replacement, one underwent LPM removal, and one was treated medically. Of the 2 LPMs wedged in the tricuspid valve apparatus, one required surgical removal and one was abandoned.

Conclusion

Tricuspid valve trauma during LPM implantation may cause significant regurgitation that results in poor outcomes and requires medical or surgical intervention. Mechanisms include direct valve injury by the delivery system, complications of difficult or unsuccessful LPM recapture, and LPM interference with valve function.
Ultrasounds versus fluoroscopy guidance for axillary vein puncture for cardiac devices implantation : a multicenter randomized comparison
Authors: Bun S-S , Taghji P , Massoure PL , Roche N , Squara F , Scarlatti D , Moceri P , Deharo JC , Ferrari E
Published: May 2022

Funding Acknowledgements

Type of funding sources: None.

Background

Axillary vein (AV) puncture, an emerging route for cardiac implantable electronic devices (CIED), can be performed under ultrasounds (US) or fluoroscopic (Fluo) guidance.

Objective

To compare US to fluroroscopy-guided AV puncture in a multicenter randomized controlled trial.

Methods

Consecutive patients admitted for CIED (first implant or upgrade, including resynchronization therapy) intervention were prospectively randomized between US or Fluo guidance for AV puncture in the three participating centers. Access performances, radiation exposure and complications were compared in both groups.

Results

102 patients were included (n = 51 patients per group). The two groups had similar characteristics concerning age (79.4 ± 10 years), and LVEF (47 ± 17%). 92 leads were implanted in both groups. AV catheterization was successful in 50/51 (98 %) in the US group versus 49/51 in the Fluo group (96 %, p = 0.56). AV access time and procedure time were not different between the two groups, respectively (156 ± 274 in the US group versus 137 ± 151 sec, p = 0.66; 54 ± 24 versus 61 ± 26 min; p = 0.13). Total fluoroscopy time (FT) and dose-area product were respectively lower in the US group, but without reaching significance: 197 ± 231 versus 247 ± 293 sec, p = 0.32; 0.39 ± 0.95 versus 0.75 ± 1.58 mGy.m², p = 0.14. FT for AV access was significantly higher in the Fluo group (51 ± 55 sec versus 0, p < 0.0001). There were two complications in each group during the 9 ± 6 months follow-up.

Conclusion

Our study demonstrates that both US and fluoroscopy-guided AV catheterization for CIED are highly effective and safe techniques. Despite similar AV access time, compared to fluo guidance, US reduce time radiation exposure by 20 %.
Echocardiographic outcomes of left bundle branch versus deep septal pacing
Authors: Ramos Jimenez J , Marco Del Castillo A , Paredes Hurtado N , Borrego Bernabe L , Fontenla A , Rodriguez Munoz DA , Salguero Bodes R , Lopez Gil M , Arribas Ynsaurriaga F
Published: May 2022

Funding Acknowledgements

Type of funding sources: None.

Introduction

Left bundle branch area pacing (LBBAP) is a rising technique that aims to preserve physiologic activation of the left ventricle. However, left bundle branch capture (LBBC) is not always achieved despite good progression of the lead into the interventricular septum, leading to what has been called deep septal pacing (DSP). In the latter, the conduction system is not captured, whose consequences on systolic function are not well known. The goal of the present work is to evaluate the repercussion on transthoracic echocardiogram (TTE) of capturing or not the left bundle branch.

Methods

Unicentric prospective study where patients in whom LBBAP was performed were consecutively included if:

Previous TTE was available with a left ventricular ejection fraction (LVEF) > 40%

A follow-up TTE performed >30 days after the implant was available

Ventricular pacing was >40% of the time at the device follow-up

LBBC was accepted if any of the following were present:

Sudden change of QRS morphology during ventricular threshold test

Left bundle potential was registered with an interval to left ventricular activation time (LVAT) equal to stimulus-LVAT time.

T-test was used to compare means between continuous variables and chi-squared to test differences between groups in the categorical ones. Two-tailed p value <0.05 was considered statistically significant.

Results

20 patients were included, 12 (60%) males, with a mean age of 74.4±10.6 years. Half of the patients (n=10) fulfilled LBBC criteria whereas the rest received DSP. Image 1 summarizes baseline characteristics and differences observed in the control TTE. After a median follow-up of 322 (interquartile range 114-325) days, LVEF increased in LBBC group whereas it decreased in DSP patients. Image 2 shows a slopegraph of the evolution of LVEF by type of stimulation. Indexed LVEDV increased in DSP group, but it was diminished in LBBC patients (p=0.03). Control TTE showed no significant differences in other parameters.

Conclusions

In non-selected patients with comparable pre-implant baseline characteristics, deep septal pacing was associated with a decrease in LVEF and an increase in LVEDV, while LBB capture showed better outcomes in these two parameters.
AV synchronous pacing in patients implanted with leadless pacemakers: a real-world cohort study
Authors: Briongos Figuero S , Estevez Paniagua A , Sanchez Hernandez A , Gomez E , Jimenez S , Vaqueriza Cubillo D , Cortes Beringola A , Munoz-Aguilera R
Published: May 2022

Funding Acknowledgements

Type of funding sources: None.

Backgroung

Leadless pacemakers (LPM) were developed to overcome complications related to endovenous devices. Devices carrying an accelerometer-based atrial sensing algorithm provided good AV synchrony in a 5-hours study.

Methods

Prospective study of patients implanted with LPM capable of AV synchronous pacing at our institution. We performed a close follow-up consisting of device check-ups 24 h after the implant and 1-3-6-12 months later. Changes in programming were guided by device counters and rate histograms. Once AV synchrony derived from counters (AM-VP + AM-VS) remained stable for at least two consecutive months, a 24 hours Holter monitoring was performed. ECG recordings were automatically and blindly analyzed with a delineation system based on the wavelet transform developed by Martinez et al.1 Cardiac cycles were defined as synchronous if a ventricular event followed the P-wave by ≤300 ms. AV synchrony was calculated by dividing the number of synchronous cycles by the total number of cardiac cycles.

Our aim was to describe AV synchrony in a real-world setting and to determine which echocardiographic and programming parameters were related to optimal AV synchrony (≥85% of total cardiac cycles).

Results

A total of 18 patients (12 males, mean age 82.6 ±8.1) were included. Indications for pacing were complete AV block (n=10) and second-degree AV block (n=8). Device reprogramming was needed in all patients at follow-up. The 24 h Holter monitoring was performed 118.8±43.8 days after the implant. Implant data and, device settings and programming at Holter date is displayed in Table 1. One patient was excluded from the analysis due to the development of severe sinus node disease. Total ECG recorded time was 386.8 hours and 1,537,995 cardiac cycles were analyzed.

Median AV synchrony, after Holter monitoring analysis, was 88.2% (interquartile range 79.9-95,1%) and 12 out of 17 patients showed an AV synchrony ≥85% of cardiac cycles. Optimal AV synchrony was related to smaller right atrium size (13.2±3.4 cm2 vs 15.6±1.2 cm2 for AV synchrony ≥85 and <85%, respectively) but no association appeared between diastolic parameters (E, A, E/A ratio, E´, A´) and AV synchrony. Rate smoothing algorithm was associated with higher rates of optimal AV synchrony (81.8% of patients with algorithm OFF vs 50% of patients activated). Besides, higher A3 threshold (7.1±3.5 m/s2 vs 4.2 ± 1.1 m/s2) and longer A3 window (620.8±25.7 ms vs 600 ms for AV synchrony ≥85% and <85%, respectively) were also linked to optimal AV synchrony. Multivariate analysis did not show any independent predictor of AV synchrony.

Conclusions

In our cohort of LPM patients we obtained high percentages of AV synchronous pacing in a real-life setting. Device reprogramming was often needed, and larger studies are desirable to confirm our data.