scholarly journals Rhythm or rate control strategy in CRT recipients with long-standing persistent atrial fibrillation - preliminary results of the PilotCRAfT study

EP Europace ◽  
2021 ◽  
Vol 23 (Supplement_3) ◽  
Author(s):  
JB Ciszewski ◽  
M Tajstra ◽  
E Gadula-Gacek ◽  
I Kowalik ◽  
A Maciag ◽  
...  

Abstract Funding Acknowledgements Type of funding sources: Public Institution(s). Main funding source(s): National Institute of Cardiology in Warsaw Statutory Grant Background The presence of atrial fibrillation (AF) in cardiac resynchronization therapy (CRT) recipients is common and AF is a marker of poorer CRT response. The negative influence of AF on CRT efficacy is mediated mainly by the drop of the effectively captured biventricular paced beats percentage (BiVp%) which should exceed 95-98% to warrant good CRT response.  Sinus rhythm (SR) restoration may improve CRT efficacy which in turn may protect AF recurrence. However, there is lack of randomized studies comparing rhythm and rate control strategies in these patients. Purpose The purpose of the Pilot-CRAfT study (NCT01850277) was to compare the efficacy of rhythm vs rate control strategy in CRT patients with long-standing persistent or permanent atrial fibrillation. Methods The study included patients with CRT and permanent or persistent AF lasting for ≥6 months, resulting in BiVp% <95%, who were randomly assigned to rhythm or rate control strategy. The rhythm control strategy comprised of external electrical cardioversion (EEC). The rate control strategy included pharmacotherapy and atrioventricular node ablation (AVNA) as needed. Both of the study arms received amiodarone. The follow-up lasted 12 months. The primary endpoint was the 12-month BiVp%. The patients underwent ECHO, cardiopulmonary test, quality of live (QoL) and clinical outcomes assessment.   Results The study included 43 CRT patients (97,7% males) aged 68,4 (SD: ±8,3) years with mean BiVp% 82,4% ±9,7% at baseline. The mean duration of AF paroxysm was 25 ±19 months. The mean baseline left ventricular ejection fraction (LVEF), left atrium area and maximal oxygen uptake (VO2max) were: 30 ±8%, 33 ±7 cm2, 14 ±5 mL/(kg*min), respectively. The EEC was performed in 19 out of 22 patients assigned to the rhythm control arm. The immediate success rate of EEC was 58%. 42% of  the rhythm control arm patients remained in SR after 12 months. In the rate control group 1 person underwent AVNA and in 1 patient spontaneous SR resumption was observed. After 12 months there was significant BiVp% increase in both the rhythm and the rate control arms (98,1 ±2,3 vs 96,3 ±3,9%, respectively. The BiVp% differences between the groups were not significant (P = 0,093). However, in the per protocol analysis, the rhythm control group had greater LVEF after 12 months as opposed to the rate control arm (36,8% vs 29,9% respectively, P = 0,039). The LVEF raised significantly in the rhythm control group (ΔLVEF 5,0 (95%CI: 1,54; 8,46)). No significant differences between the groups in the VO2max, QoL, clinical and safety end-points were noticed. Conclusions Structured follow-up of CRT patients with long-standing persistent or permanent AF leads to significant BiVp% increase exceeding 95%. The rate control strategy did not improve CRT effectivness, irrespective of high BiVp%. However limited in the efficacy, the rhythm control strategy may improve CRT outcome in these patients, resulting in LVEF increase.

2020 ◽  
Vol 21 (Supplement_1) ◽  
Author(s):  
R Piatkowski ◽  
D A Kosior ◽  
J Kochanowski ◽  
M Szulc

Abstract BACKGROUND Patients with persistent atrial fibrillation (AF) can be managed with either rhythm or rate control strategy. The restoration and maintenance of the sinus rhythm (SR) is not superior to the rate control regarding the total mortality and the rate of thromboembolic complications. Data concerning the effect of these strategies on left ventricular morphology and function is missing. PURPOSE The objective of our prospective randomised multicenter study in patients with persistent AF was to evaluate the effect of these two approaches on left ventricular morphology and function. METHODS The study group consisted of 205 patients (F/M 71/134; mean age 60.8 ± 11.2 years), including 101 patients randomized to the rate control approach (Group I) and 104 patients randomized to SR restoration with cardioversion and subsequent antiarrhythmic drug treatment (Group II). Mean duration of AF was 231.8 ± 112.4 days. At the end of follow-up (12 months), SR was present in 64% of patients in Group II. Echocardiographic examination was performed at a baseline and at 2 and 12 months. In the rate-control group, both right (22.1 ± 4.1 vs. 23.2 ± 3.8 cm2; p < 0.05) and left atrial (25.9 ± 5.2 vs. 26.8 ± 4.6 cm2 p < 0.05) enlargement was observed during the 12 months follow-up. A significant decrease in right (21.8 ± 3.0 vs. 21.2 ± 3.5 cm2; p < 0.05) and left atrial (26.2 ± 4.6 vs. 25.5 ± 5.0 cm2; p < 0.05) size in the rhythm control arm was observed. Both strategies led to a significant increase in left ventricular fractional shortening (32.1 ± 7.3 vs. 34.2 ± 6.5% and 31.3 ± 6.7 vs. 35.5 ± 8.9%, respectively; p < 0.05). The comparison of the left ventricular end-diastolic diameter revealed no difference within and between groups (50.8 ± 5.6 mm vs. 52.2 mm ± 6.8 mm at a baseline and 50.0 ± 6.0 vs. 52.0 ± ± 7.4 mm at 12 months, respectively). In rhythm-control group such trend was observed only in pts. with successfully maintained SR. According to LV function improvement, rhythm-control strategy was preferred in pts. with hypertension (RR 2.63; 95% C.I.: 0.93-5.45; p < 0.05) or congestive heart failure in NYHA II or III class (RR 2.13; 95% C.I.: 0.98-4.42; p < 0.05). CONCLUSIONS Both strategies led to a significant increase in LV FS. Rate-control strategy led to right and left atrium enlargement, but rhythm control resulted in their decrease.


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


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
R Rordorf ◽  
S Cornara ◽  
L Frigerio ◽  
A Sanzo ◽  
E Chieffo ◽  
...  

Abstract Background Pulmonary veins isolation (PVI)is an effective therapy for atrial fibrillation (AF), recommended by current guidelines. However, recurrences after first radio-frequency (RF) catheter ablation (CA) are still high. PV reconnection could be due to ineffective transmural lesions; automated ablation lesion tags (the VisiTag algorithm) based on predefined parameters of catheter stability and contact force (CF) have been developed to allow the detection of ineffective ablation lesion, nevertheless there is a lack of multicenter studies exploring this technology. Objective the aim of our study was to assess the rate of recurrence after a first PVI procedure in a large, multicentric Italian population and to explore the efficacy of Visitag algorithm (CARTO 3) used to guide RF ablation of AF. Methods we analyzed 214 patients of the SMOP-AF study (Substrate Mapping as Outcome Predictor in Atrial Fibrillation Ablation), a prospective multi-centric study enrolling patients with paroxysmal and persistent AF undergoing a first PVI procedure after an high-density mapping during sinus rhythm. During the procedure, ablation was guided by an automated annotation system in which tag based on predefined parameters were displayed real-time in each lesion site on the electroanatomical map. Visitag settings for the catheter position stability were a 2,5 mm distance limit for at least 7 sec and a minimum CF of 5 g over 30% of the ablation and a FTI>400 g*s. Where available (n=106, 49.5%), Ablation Index (AI), which also incorporates information on delivered RF power, was used instead of FTI to guide RF ablation with a threshold range of 400–550 for anterior/roof and 330–420 for posterior/inferior segments. Minimum and mean contact force, time and power values for each RF-lesion were recorded while both FTI and AI values were calculated automatically by the CARTO system. Comparison between groups were made by cross-tables, Mann-Whitney or Student T test as appropriated. Results the mean age of the enrolled population was 59±9 years, left ventricular ejection fraction was 59±9%. AF was paroxysmal in 89.7%, persistent in 10.3% of the patients and refractory to at least one anti-arrhythmic drug in 86.4% of the population. At 3 months follow-up 85% of the patients were free from AF recurrences and the success rate increased to 90.8% at 3–6 months, and 86.3% at 3–12 months follow-up. The mean ablation time was shorter in AI-guided vs. FTI-guided procedures (31±9 vs 46±29 min; p<0.001). There was a trend toward a reduction in AF recurrences when AI vs. FTI was used, both at 6 and 12 months (respectively 5,4% vs 13.6%; p 0.06 and 9.6% vs 18.5%; p 0.08). Conclusion PVI isolation using dedicated algorithms developed to guide the effectiveness of RFCA leads to a very high success-rate after a single procedure. The use of AI, which integrates contact force information with delivered power, reduces the procedural time and increases the overall success-rate


Author(s):  
Jonathan P. Piccini ◽  
Christopher Dufton ◽  
Ian A. Carroll ◽  
Jeff S. Healey ◽  
William T. Abraham ◽  
...  

Background - Bucindolol is a genetically targeted β-blocker/mild vasodilator with the unique pharmacologic properties of sympatholysis and ADRB1 Arg389 receptor inverse agonism. In the GENETIC-AF trial conducted in a genetically defined heart failure (HF) population at high risk for recurrent atrial fibrillation (AF), similar results were observed for bucindolol and metoprolol succinate for the primary endpoint of time to first atrial fibrillation (AF) event; however, AF burden and other rhythm control measures were not analyzed. Methods - The prevalence of ECGs in normal sinus rhythm, AF interventions for rhythm control (cardioversion, ablation and antiarrhythmic drugs), and biomarkers were evaluated in the overall population entering efficacy follow-up (N=257). AF burden was evaluated for 24 weeks in the device substudy (N=67). Results - In 257 patients with HF the mean age was 65.6 ± 10.0 years, 18% were female, mean left ventricular ejection fraction (LVEF) was 36%, and 51% had persistent AF. Cumulative 24-week AF burden was 24.4% (95% CI: 18.5, 30.2) for bucindolol and 36.7% (95% CI: 30.0, 43.5) for metoprolol (33% reduction, p < 0.001). Daily AF burden at the end of follow-up was 15.1% (95% CI: 3.2, 27.0) for bucindolol and 34.7% (95% CI: 17.9, 51.2) for metoprolol (55% reduction, p < 0.001). For the metoprolol and bucindolol respective groups the prevalence of ECGs in normal sinus rhythm was 4.20 and 3.03 events per patient (39% increase in the bucindolol group, p < 0.001), while the rate of AF interventions was 0.56 and 0.82 events per patient (32% reduction for bucindolol, p = 0.011). Reductions in plasma norepinephrine (p = 0.038) and NT-proBNP (p = 0.009) were also observed with bucindolol compared to metoprolol. Conclusions - Compared with metoprolol, bucindolol reduced AF burden, improved maintenance of sinus rhythm, and lowered the need for additional rhythm control interventions in patients with HF and the ADRB1 Arg389Arg genotype.


Circulation ◽  
2015 ◽  
Vol 132 (suppl_3) ◽  
Author(s):  
Moritake Iguchi ◽  
Hisashi Ogawa ◽  
Hirofumi Sugiyama ◽  
Nobutoyo Masunaga ◽  
Mitsuru Ishii ◽  
...  

Purpose: Previous reports suggested that lenient rate control was not inferior to strict rate control among patients with chronic atrial fibrillation (AF). However, the impact of heart rate (HR) on the incidence of cardiovascular events is not clearly understood. Methods: The Fushimi AF Registry, a community-based prospective survey, was designed to enroll all of the AF patients in Fushimi-ku, Kyoto, Japan. At present, follow-up data were available in 3,514 patients (median follow-up period, 842 days). 1,622 patients had chronic AF, and we obtained ECG findings in 1,561 patients. We divided these patients into three groups based on their heart rate; high-HR (HR≥110) (n=179), intermediate-HR (80≤HR<110) (n=695), and low-HR (HR<80) (n=687), and explored the cardiovascular events (composite of cardiovascular death, hospitalization for heart failure, and arrhythmic events). Results: Mean HR was 128±13 bpm, 93±8 bpm, and 67±9 bpm, respectively. High HR group was younger than other groups, but the prevalence of heart failure was the highest (44.7%, 37.0%, 32.3%; p=0.007) and left-ventricular ejection fraction was the lowest (56.5±14.6%, 60.7±11.9%, 62.7±10.5%; p<0.0001). Prescription of beta-blocker (37.4%, 28.9%, 30.0%) and diltiazem (2.8%, 2.9%, 4.2%) was comparable, but prescription of verapamil was the highest in high-HR group (19.0%, 12.4%, 8.0%; p=0.0001), and prescription of digitalis was the highest in low-HR group (14.0%, 18.2%, 23.4%; p=0.005). Mean CHADS2 score was 2.3±1.3, 2.2±1.3, and 2.2±1.4, respectively. In Kaplan-Meier analysis, the incidence of cardiovascular events was higher in high-HR groups than intermediate- and low-HR group (9.2%/year vs 5.8%/year, p=0.02), but was similar between intermediate- and low-HR group (6.2%/year vs 5.4%/year, p=0.3). The incidence of stroke or systemic embolism was comparable between the three groups (2.6%/year, 3.6%/year, 2.4%/year). Cox proportional hazard ratios [95%CI] of high- and intermediate-HR for cardiovascular events compared to low-HR were 1.63 [1.06-2.44] and 1.10 [0.81-1.79], respectively. Conclusions: Among chronic AF patients, the incidence of cardiovascular events was higher in the patients with high-HR, but was similar between intermediate- and low-HR groups.


EP Europace ◽  
2020 ◽  
Vol 22 (Supplement_1) ◽  
Author(s):  
J B Ciszewski ◽  
M Tajstra ◽  
E Gadula-Gacek ◽  
I Kowalik ◽  
A Maciag ◽  
...  

Abstract Funding Acknowledgements Institute of Cardiology statutory grant (grant no.: 2.30/VII/13) Background Atrial fibrillation (AF) and heart failure (HF) often co-exist and influence each other. The presence of AF is often regarded as a marker of HF severity.  Moreover, AF in cardiac resynchronization therapy (CRT) recipients hinders the CRT effectiveness in HF treatment by the reduction of the percentage of biventricular paced beats (BiVp%). Sinus rhythm (SR) restoration makes CRT more effective in HF treatment which may protect AF recurrence. Purpose To establish the effectiveness of electrical external cardioversion (EEC) in CRT patients with long-standing persistent AF or permanent, pre-treated with amiodarone. Methods The population of the study comprised of the Pilot-CRAfT study participants (NCT01850277), that is patients with CRT, long-standing persistent or considered as permanent AF and BiVp ≤ 95% who were randomly assigned to the "rhythm control" or the "rate control" strategy. The inclusion criteria included an AF paroxysm lasting at least 6 months. Both treatment arms received amiodarone beginning with the loading dose. Subsequently, patients assigned to the rhythm control strategy underwent electrical cardioversion. Rate control strategy included pharmacotherapy and atrioventricular node ablation, as needed. The follow up visit was performed 3 months after the enrolment visit. The EEC effectiveness, an AF recurrence within the 3 month period, BiVp% changes, the EEC parameters  and the EEC related complications were analysed. Results Out of 48 participants enrolled in the Pilot-CRAfT study, 25 patients were assigned to the rhythm control arm. The mean age of the rhythm control arm patients was 69,5 years , the mean left ventricular ejection fraction was 30,6% , the mean left atrium diameter was 53 mm and the median duration of persistent AF was 16 months. SR was obtained in 12 out of 20 (60%) patients who underwent the EEC . On the 3 month visit 8 patients remained in SR (40%). In patients with an AF paroxysm lasting less than 1 year the success rate was 100% vs 50% in the AF lasting 1 year at least (p = 0,11 ). After 3 months, SR remained in 100% vs 25% of patients, respectively (p =0,015.).  The effectiveness of anterior-posterior EEC electrodes placement was 20% and it was 71% for the anterior-lateral patch location . The EEC resulted in significant BiVp% rise - also in the whole intention-to-treat (ITT) group:  88,58%  before the EEC vs 96,68% after the EEC  (p = 0,002). No severe adverse events of the EEC were observed. Conclusions The electrical cardioversion of persistent atrial fibrillation lasting more than 6 months in patients with severe HF and treated with CRT is characterised by modest success rate, even after the amiodarone pre-treatment. However, the ECC ensures significant rise in BiVp% close to 97%, even in the whole EEC group based on the ITT principle. The AF paroxysm duration &lt;1 year and the anterior-posterior patch placement may ensure better EEC efficacy in this group of patients.


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.


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