Early rhythm-control ablation therapy in preventing AF recurrences: insight from the CHARISMA Registry

EP Europace ◽  
2021 ◽  
Vol 23 (Supplement_3) ◽  
Author(s):  
L Segreti ◽  
A De Simone ◽  
V Schillaci ◽  
C Pandozi ◽  
MG Bongiorni ◽  
...  

Abstract Funding Acknowledgements Type of funding sources: None. Background An early and comprehensive rhythm-control therapy emerges as a need to treat AF in an effective way and to improve the ablation outcomes, in terms of arrhythmia-free survival. Purpose We aimed to investigate the importance of timing of ablation in preventing AF recurrences. Methods 153 consecutive patients (pts) undergoing AF ablation from the CHARISMA registry at 8 Italian centres were included. Ablations were guided by a novel radiofrequency ablation catheter with local impedance (LI)-sensing capability through a dedicated algorithm (DirectSense, Boston Scientific). Pts were grouped as early treated (ET) if the procedure was performed within 1 year after the first AF episode and as delayed treated (DT) if admitted for ablation after more than 1 year. The ablation endpoint was PVI as assessed by entrance and exit block. Post-ablation follow-up was scheduled at 3, 6 and 12 months. AF and atrial tachycardia (AT) recurrences were considered as long-term endpoint. Results Of the 153 pts enrolled (69.9% male, 59 ± 10 years, 61.4% paroxysmal AF, 38.6% persistent AF), 123 (80.4%) met Class I indications, 23 (15%) Class IIa indications and 7 (4.6%) Class IIb indications according to current ESC AF guidelines. The mean time to ablation procedure from the first AF episode was 1034 ± 1483 days. Eighty pts (52.3%) were included in ET group, whereas 73 pts (47.7%) in DT group. No differences were found between AF type in terms of ablation strategy (53.3% of the cases -52 out 94- were classified as ET for paroxysmal AF vs 47.5% of the cases -28 out 59- were ET for persistent AF, p = 0.4346). At the end of the procedures, all PVs had been successfully isolated in all study pts. During a mean follow-up of 366 ± 130 days, 18 pts (11.8%) suffered an AF/AT recurrence after the 90-day blanking period. Recurrences occurred mostly in the DT group compared to the ET one (13 out 73 -17.8%- vs 5 out 80 -6.3%-, p = 0.042) and the time to AT/AF recurrence was longer in the ET group (HR = 0.2876, 95%CI: 0.1029 to 0.8038; p = 0.0181). On multivariate logistic analysis adjusted for baseline confounders, only hypertension (HR = 4.66, 95%CI: 1.5 to 14.48, p = 0.0081) was independently associated with recurrences. An early rhythm-control therapy was associated with a low risk of recurrences beyond the hypertension risk factor, ranging from 2% (no hypertension and an ET ablation therapy) to 30.3% (with hypertension and a DT procedure) (Figure 1). Conclusion A LI-guided ablation strategy for PVI proved to be safe and effective and resulted in a very high recurrence-free rate. An early rhythm-control therapy in the absence of common risk factors was associated with the lowest rate of recurrences. Abstract Figure. AT/AF Recurrence

EP Europace ◽  
2021 ◽  
Vol 23 (Supplement_3) ◽  
Author(s):  
D Musat ◽  
NS Milstein ◽  
M Saberito ◽  
A Bhatt ◽  
M Habibi ◽  
...  

Abstract Funding Acknowledgements Type of funding sources: None. Background Cryoballoon pulmonary vein isolation (CB) is an accepted method for ablation in patients with atrial fibrillation (AF). A three-month blanking period (BP) is commonly used in clinical trials and practice. However, the actual BP duration in patients (pts) on an antiarrhythmic drug (AAD) at time of ablation remains undefined. Objective To objectively define the BP duration in pts undergoing CB while taking an AAD. Methods We enrolled consecutive pts with AF who had CB PVI while on an AAD. All pts had an implantable loop recorder (ILR). We prospectively followed all pts and determined the time to last AF episode during the 90-day post-PVI BP. This was then correlated with likelihood of having an AF recurrence between 3-12 months post-PVI. Results The cohort included 92 pts (66 ± 10 years; 62 [67%] male; 33 [36%] PAF; CHA2DS2-VASc 2.6 ± 1.7). AADs used included dofetilide (42), dronedarone (14), amiodarone (25), sotalol and propafenone (3 each), and flecainide (5). The AAD was stopped at a median of 80 [36, 105] days post-PVI.  We defined 4 distinct groups: (1) no AF in 90-day BP (n = 45 [49%]); (2) last AF within 30 days of PVI (n = 17 [18%]); (3) last AF within 60 days of PVI (n = 13 [15%]); and (4) last AF within 90 days of PVI (n = 17 [18%]). Following the 90-day BP, 47 (51%) pts had a recurrence of AF. Once recurrent AF was observed > 30 days post-ablation, patients had high likelihood of having a long term AF recurrence (p = 0.037, Figure). Conclusion Our data suggest that the optimal BP duration in AF patients undergoing CB PVI while taking an AAD is 30 days. An AF recurrence after 30 days is associated with a very high likelihood of recurrent AF during longer-term follow-up. Abstract Figure.


EP Europace ◽  
2021 ◽  
Vol 23 (Supplement_3) ◽  
Author(s):  
D Musat ◽  
NS Milstein ◽  
M Saberito ◽  
A Bhatt ◽  
M Habibi ◽  
...  

Abstract Funding Acknowledgements Type of funding sources: None. Background Cryoballoon pulmonary vein isolation (CB) is an accepted method for ablation in patients with atrial fibrillation (AF). A three-month blanking period (BP) is commonly used in clinical trials and practice. However, when the optimal BP duration differs in patients (pts) on or off an antiarrhythmic drug (AAD) at time of ablation remains undefined. Objective To compare the BP duration in pts undergoing CB while either taking or not taking an AAD. Methods We enrolled consecutive pts with AF who had CB PVI while on an AAD. All pts had an implantable loop recorder (ILR). We prospectively followed all pts and determined the time to last AF episode during the 90-day post-PVI BP. This was then correlated with likelihood of having an AF recurrence between 3-12 months post-PVI. Results The cohort included 164 pts (66 ± 9 years; 97 [60%] male; 90 [55%] PAF; CHA2DS2-VASc 2.7 ± 1.7). Ablation was performed with 92 (56%) pts taking an AAD, which was stopped at a median of 80 [36, 105] days post-PVI. We defined 4 distinct groups: (1) no AF in 90-day BP (n = 75 [46%]); (2) last AF within 30 days of PVI (n = 32 [20%]); (3) last AF within 60 days of PVI (n = 17 [10%]); and (4) last AF within 90 days of PVI (n = 40 [24%]). Following the 90-day BP, 81 (49%) pts had a recurrence of AF. Long-term freedom from recurrent AF was similar in pts who did and did not use an AAD, irrespective of BP duration (Figure). Conclusion Our data suggest that the optimal BP duration in AF patients undergoing CB PVI while taking an AAD is 30 days. An AF recurrence after 30 days is associated with a very high likelihood of recurrent AF during longer-term follow-up, irrespective of whether an AAD is being used or not. Abstract Figure.


Author(s):  
Igor Belluschi ◽  
Elisabetta Lapenna ◽  
Davide Carino ◽  
Cinzia Trumello ◽  
Manuela Cireddu ◽  
...  

Abstract OBJECTIVES Previous series showed the outcomes of thoracoscopic ablation of stand-alone symptomatic paroxysmal atrial fibrillation (AF) for up to 7 years of follow-up. The goal of this study was to assess the long-term durability of surgical pulmonary vein isolation (PVI) beyond 7 years. METHODS Fifty consecutive patients {mean age 55 [standard deviation (SD): 11.2] years, previous catheter ablation in 56%, left ventricular ejection fraction 60% (SD: 4.6), left atrium volume 65 ml (SD: 17)} with stand-alone symptomatic paroxysmal AF underwent PVI through bilateral thoracoscopy ablation between 2005 and 2014. The CHA2DS2-VASc score was ≥2 in 12 patients (24%). RESULTS No hospital deaths occurred. At hospital discharge all patients but 1 (2%) were in sinus rhythm (SR). Follow-up was 100% complete [mean 8.4 years (SD: 2.3), max 15]. The 8-year cumulative incidence function of AF recurrence, with death as a competing risk, on or off class I/III antiarrhythmic drugs (AADs)/electrocardioversion/re-transcatheter ablation (TCA) was 20% (SD: 5; 95% confidence interval: 10, 32); and off class I/III AADs/electrocardioversion/re-TCA was 52% (SD: 7; 95% confidence interval: 0.83, 8.02). At 8 years, the predicted prevalence of patients in SR was 87% and 53% were off class I/III AADs/electrocardioversion/re-TCA. The recurrent arrhythmia was AF in all patients except 2, who had atypical atrial flutter (4%). No predictors of AF recurrence were identified. At the last follow-up, 76% of the patients showed European Heart Rhythm Association class I. No strokes or thromboembolic events were documented and 76% of the subjects were off anticoagulation therapy. CONCLUSIONS Despite a considerable AF recurrence rate, our single-centre, long-term outcome of surgical PVI showed encouraging data, with the majority of patients remaining in SR, although many of them were on antiarrhythmic therapy.


2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
G R Rios-Munoz ◽  
N Soto ◽  
P Avila ◽  
T Datino ◽  
F Atienza ◽  
...  

Abstract Introduction Treatment of atrial fibrillation (AF) remains sub-optimal, with low success in pulmonary vein isolation (PVI) ablation procedures in long-standing-persistent AF patients. The maintenance mechanisms of AF are still under debate. Rotational activity (RA) events, also known as rotors, may play a role in perpetuating AF. The characterisation of these drivers during electroanatomical (EA) guided ablation procedures in relationship with follow-up and recurrence ratios in AF patients is necessary to design new ablation strategies to improve the AF treatment success. Purpose We report an AF patient cohort of endocardial mapping and PVI ablation procedures with additional RA events detected during the EA study. We aim to study the presence and distribution of RA in AF patients and its impact on AF recurrence when only PVI ablation is performed. Methods 75 persistent consecutive AF patients (age 60.7±9.8, 74.7% men) underwent EA mapping and RA detection with an automatic algorithm. The presence of RA was annotated on the EA map based on the unipolar electrograms (EGMs) registered with a 20-pole catheter. RA presence was analysed at different left atrial locations (37.2±14.8 sites per patient). AF recurrence was evaluated in follow-up after treatment. Results At follow-up (9±5 months), 50% of the patients presented AF recurrence. Patients with RA had more dilated atria in terms of volumes (p=0.002) and areas (p=0.001). Patients with RA exhibited higher mean voltage EGMs 0.6±0.3 mV vs 0.5±0.2 mV (p=0.036), with shorter cycle lengths 169.1±26.0 ms vs. 188.4±44.2 ms (p=0.044). Finally, patients with RA presented more AF recurrence rates than patients with no RA events (p=0.007). No significant differences were found in terms of comorbidities, e.g., heart failure, hypertension, COPD, stroke, SHD, or diabetes mellitus. Conclusions The results show that patients with more RA events and those with RA outside the PVI ablated regions presented higher AF recurrence episodes than those with no RA or events inside the areas affected by radio-frequency ablation. The study suggests that further ablation treatment of the areas harboring RA might be necessary to reduce the recurrence ratio in AF patients. FUNDunding Acknowledgement Type of funding sources: Public grant(s) – National budget only. Main funding source(s): Instituto de Salud Carlos III; Sociedad Española de Cardiología


EP Europace ◽  
2021 ◽  
Vol 23 (Supplement_3) ◽  
Author(s):  
G Bisignani ◽  
A Bisignani ◽  
AL Cavaliere ◽  
M Lovecchio ◽  
S Valsecchi ◽  
...  

Abstract Funding Acknowledgements Type of funding sources: None. Background To ensure effective defibrillation with the subcutaneous implantable cardioverter defibrillator (S-ICD), both the lead and the generator must be adequately positioned extrathoracically. We assessed the long-term adequacy of the S-ICD system position and its stability in a group of patients who received the S-ICD by means of the two-incision intermuscular technique. Methods The PRAETORIAN score uses chest radiography to provide feedback on S-ICD positioning, and identifies patients with high defibrillation thresholds. We compared radiographs taken immediately after implantation and on 12-month follow-up examination. Results We analyzed data from 38 patients with the S-ICD generator positioned in an intermuscular pocket. The median PRAETORIAN score was 38 [25th to 75th percentile: 30 to 60]. Two (5%) patients had a score of 90 (intermediate risk of conversion failure). The thickness of the adipose tissue between the coil and the sternum was ≤1 coil width in 72% of patients, the generator was on, or posterior to, the midline in 94% of patients, and the amount of fat tissue between the generator and the thoracic wall was less than the generator width in 78% of patients. No generator or electrode dislodgments were detected on analyzing radiographs collected at the 12-month visit. In all patients, assessment of the PRAETORIAN score confirmed the values calculated on post-implantation analysis. During follow-up, no ineffective therapies, sudden cardiac or device-related deaths occurred. Conclusions The position of the S-ICD system implanted using the two-incision intermuscular technique was adequate at the time of implantation and remained stable after 12 months.


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
F Dalgaard ◽  
S Al-Khatib ◽  
J Pallisgaard ◽  
C Torp-Pedersen ◽  
T B Lindhardt ◽  
...  

Abstract Background Treatment of AF patients with rate or rhythm drug therapy have shown no difference in mortality in clinical trials. However, the generalizability of these trials to real-world populations can be questioned. Purpose We aimed to investigate the all-cause and cardiovascular (CV) mortality risk in a nationwide AF cohort by treatment strategy (rate vs. rhythm) and by individual drug classes. Methods We queried the Danish nationwide registries from 2000 to 2015 to identify patients with AF. A rate control strategy included the use of one or more of the following medications: beta-blocker, digoxin, and a class-4 calcium channel blocker (CCB). A rhythm control strategy included the use of an anti-arrhythmic drug (amiodarone and class-1C). Primary outcome was all-cause mortality. Secondary outcome was CV mortality. Adjusted incidence rate ratios (IRR) were computed using Poisson regression with time-dependent covariates allowing patients to switch treatment during follow-up. Results Of 140,697 AF patients, 131,793 were on rate control therapy and n=8,904 were on rhythm control therapy. At baseline, patients on rhythm control therapy were younger (71 yrs [IQR: 62–78] vs 74 [65–82], p<0.001) more likely male (63.5% vs 51.7% p<0.001), had more prevalent heart failure (31.1% vs 19.4%, p<0.001) and ischemic heart disease (40.1% vs. 23.3%, p<0.001), and had more prior CV-related procedures; PCI (7.4% vs. 4.0% p<0.001) and CABG (15.0% vs. 2.3%, p<0.001). During a median follow up of 4.0 (IQR: 1.7–7.3) years, there were 64,653 (46.0%) deaths from any-cause, of which 27,025 (19.2%) were CVD deaths. After appropriate adjustments and compared to rate control therapy, we found a lower IRR of mortality and CV mortality in those treated with rhythm control therapy (IRR: 0.93 [95% CI: 0.90–0.97] and IRR 0.84 [95% CI: 0.79–0.90]). Compared with beta-blockers, digoxin was associated with increased risk of all-cause and CV mortality (IRR: 1.26 [95% CI: 1.24–1.29] and IRR: 1.32 [95% CI: 1.28–1.36]), so was amiodarone: IRR for all-cause mortality: 1.16 [95% CI: 1.11–1.21] and IRR for CV mortality: 1.12 [95% CI: 1.05–1.19]. Class-1C was associated with lower all-cause (0.43 [95% CI: 0.37–0.49]) and CV mortality (0.35 [95% CI: 0.28–0.44]). Figure 1. Models were adjusted for age, sex, ischemic heart disease, stroke, chronic obstructive pulmonary disease, chronic kidney disease, valvular atrial fibrillation, bleeding, diabetes, ablation, pacemaker, implantable cardioverter defibrillator, hypertension, heart failure, use of loop diuretics, calendar year, and time on treatment. Abbreviations; CCB; calcium channel blocker, PY; person years. Conclusions In a real-world AF cohort, we found that compared with rate control therapy, rhythm control therapy was associated with a lower risk of all-cause and CV mortality. The reduced mortality risk with rhythm therapy could reflect an appropriate patient selection. Acknowledgement/Funding The Danish Heart Foundation


2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
A J Leikas ◽  
I Hassinen ◽  
A Hedman ◽  
A Kivela ◽  
S Yla-Herttuala ◽  
...  

Abstract Backgound/Introduction In phase I KAT301 trial, adenovirus-mediated intramyocardial vascular endothelial growth factor-DΔNΔC (VEGF-D) gene therapy (GT) resulted in a significant improvement in myocardial perfusion reserve and relieved angina at 1-year follow-up without major safety concerns. Purpose Our objective was to investigate the long-term safety and efficacy of AdVEGF-D GT. A total of 30 patients (24 VEGF-D and 6 randomized and blinded controls) participated in KAT301 trial. Methods The mean follow-up time was 8.2 years (range 6.3–10.4 years). Patients were interviewed for the current severity of symptoms (Canadian Cardiovascular Society class, CCS) and perceived benefit from GT. Medical records were reviewed to assess the incidence of major cardiovascular adverse events (MACEs) and other predefined endpoints including cancer. Results MACE occurred in 15 patients in VEGF-D group and in five patients in control group (21.5 vs. 24.9 per 100 patient-years; hazard ratio 0.90; 95% confidence interval 0.09–9.32; P=0.95). Mortality and comorbidity were similar between the groups. Angina symptoms (CCS) were less severe compared to baseline in VEGF-D group (1.9 vs. 2.9; P=0.006) but not in control group (2.2 vs. 2.6; P=0.414). Conclusion(s) Our study indicates that intramyocardial AdVEGF-D GT is safe in the long-term. In addition, the relief of symptoms remained significant during the follow-up. FUNDunding Acknowledgement Type of funding sources: Public hospital(s). Main funding source(s): Kuopio University Hospital Heart Center Figure 1. The incidence of MACE Figure 2. CCS class


2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
M Saberito ◽  
N Milstein ◽  
A Bhatt ◽  
M Habibi ◽  
T Sichrovsky ◽  
...  

Abstract Background At time of cryoballoon (CB) pulmonary vein isolation (PVI), some patients with atrial fibrillation (AF) are on an antiarrhythmic drug (AAD) while others are not. The impact of AAD use at time of CB PVI on the duration of post-ablation blanking period (BP) is unknown. Objective To determine whether the optimal BP duration differs between pts who were and were not taking an AAD at time of CB PVI. Methods We enrolled consecutive pts with AF who had initial CB PVI; all pts had an implantable loop recorder (ILR). We prospectively followed all pts and determined the time to last AF episode during the 90-day post-PVI BP. This was then correlated with likelihood of having an AF recurrence between 3–12 months post-PVI. Results The cohort included 165 pts (66±9 years; 99 [60%] male; 91 [55%] PAF; CHA2DS2-VASc 2.7±1.6). An AAD was being used at some point prior to ablation in 120 (73%) pts. An AAD was being used at time of CB PVI in 92 (77%) of these 120 pts; this was stopped at a median of 80 [36, 105] days post-PVI. We defined 4 distinct groups: (1) no AF in 90-day BP (n=75 [45%]); (2) last AF within 30 days of PVI (n=32 [19%]); (3) last AF within 60 days of PVI (n=17 [10%]); and (4) last AF within 90 days of PVI (n=41 [25%]). Patients not exposed to an AAD prior to CB PVI had significantly lower likelihood of having no AF in the first 90-days post ablation (p=0.004, Figure). In contrast, if AF was observed post-ablation, as time from ablation to recurrence increased, so did likelihood of long-term failure from ablation (Figure); this relationship was not impacted by use of an AAD. Conclusion The best long-term outcomes post CB PVI are seen in pts who had no prior exposure to an AAD and had no AF within the first 90 days of ablation. Subsequently, as the time from ablation to AF recurrence increased within the 90-day BP, so did likelihood of recurrent AF during long-term follow-up, irrespective of whether an AAD was or was not used. FUNDunding Acknowledgement Type of funding sources: None.


EP Europace ◽  
2020 ◽  
Vol 22 (Supplement_1) ◽  
Author(s):  
P Papakonstantinou ◽  
E Simantirakis ◽  
E Kanoupakis ◽  
F Parthenakis ◽  
P Vardas

Abstract Funding Acknowledgements The study was supported by Medtronic Inc Background The natural history of paroxysmal atrial fibrillation (AF) after the first clinical AF episode is not well known. AF burden is of clinical significance as it may have clinical implications concerning the long-term management of the arrhythmia and the decision-making on AF patients.  Purpose To observe the natural history of AF in patients after their first clinical paroxysmal AF episode.  Methods Thirty consecutive patients (age 66.9 ± 10 years; 14 men) received an implantable loop recorder (ILR) after their first symptomatic paroxysmal AF episode. We recorded the AF recurrences and burden (clinical and subclinical AF) during a follow-up period of three years. We excluded patients with persistent or permanent AF and patients with an episode of AF attributed to reversible or transient causes.  Results Eight patients (26.6%) did not present any AF recurrence during the first year of the follow-up period. Five patients (16.6%) did not also suffer any AF episode during the second year, while in three patients (10%) no AF episode was recorded during the three-year follow-up period. In 16 patients (53.3%) the AF burden was increased during the second year of follow-up period while in 9 patients (30%) the AF burden was decreased. During the third year of follow-up period the AF burden was increased in 19 patients (63.3%), decreased in 7 patients (23.3%) and remained almost the same in 4 patients (13.3%). Five patients (16.6%) presented at least one episode of persistent AF during the follow-up period. Seven patients (23.3%) suffered only from symptomatic AF episodes, while in nine patients (30%) only asymptomatic AF episodes were recorded. Eleven patients (36.7%) had both types of AF episodes (symptomatic and asymptomatic).  Conclusions The AF recurrence and burden increased in most AF patients during the three-year follow-up period. However, some patients did not suffer any AF recurrence or they presented a decrease in AF burden. Paroxysmal AF clinical profile differs among the AF patients significantly and this indicates that an individualized approach via long-term rhythm monitoring may be of clinical significance, at least in some newly diagnosed AF patients.


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
D Musat ◽  
N Milstein ◽  
R Shaw ◽  
A Bhatt ◽  
M Preminger ◽  
...  

Abstract Background Cryoballoon (CB) pulmonary vein isolation (PVI) is increasingly being used in patients (pts) with persistent atrial fibrillation (AF). However, there are limited data about the pattern of atrial fibrillation (AF) recurrence in these pts. Objective To assess, using an implantable loop recorder (ILR), the patterns of AF recurrence following CB PVI in pts with persistent atrial fibrillation. Methods We enrolled consecutive pts with persistent AF ablation undergoing their first CB ablation. Other cavotricuspid isthmus ablation when indicated, no other ablation was performed. A Reveal LINQ ILR (Medtronic) was implanted <3 months following ablation; all pts had a minimum of 1-year follow-up. The recurrence of any atrial arrhythmia was determined and adjudicated; 4 distinct AF patterns were characterized (Figure). Results We studied 64 pts (66±9 years; 50 [78%] male; CHA2DS2-VASc 2.6±1.9) with persistent AF; 52 (81%) pts were on an antiarrhythmic drug (AAD) peri-ablation. During 803±361 days of follow-up, 33 (52%) pts had their 1st AF recurrence 91–365 days post-ablation and another 17 (27%) pts had their 1st AF recurrence >365 days post-ablation. No AF was seen in 14 (31%) pts. Most pts (33 of 50, 66%) with AF recurrence presented with 1 of 3 distinct patterns of paroxysmal AF (Figure), which ranged from 22 min to 124 hours. In 2/3 of these pts, all AF recurrences lasted <24 hours. Only 17 (34%) pts recurred with persistent AF. Conclusion Following single CB PVI, most pts with persistent AF remained free of persistent AF during long-term follow-up. Most pts with recurrent AF have 1 of 3 distinct patterns with episodes commonly last <24 hours. These data suggest that CB PVI ablation may halt AF progression in pts initially presenting with persistent AF.


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