Impact of Structural Heart Disease on the Acute Complication Rate in Atrial Fibrillation Ablation

Results From the German Ablation Registry

Boris A. Hoffmann, M.D., B.SC; Karl-Heinz Kuck, M.D; Dietrich Andresen, M.D; Stefan G. Spitzer, M.D; Ellen Hoffmann, M.D; Burghard Schumacher, M.D; Lars Eckardt, M.D; Johannes Brachmann, M.D; Rüdiger Becker, M.D; Daniel Steven, M.D; Thomas Rostock, M.D; Claus JüNger, M.D., M.San; Jochen Senges, M.D; Stephan Willems, M.D

Disclosures

J Cardiovasc Electrophysiol. 2014;25(3):242-249.

Abstract and Introduction

Abstract

Acute Complication Rate in AF Ablation

Introduction. Catheter ablation (CA) has emerged as a widespread therapeutic option in the treatment of atrial fibrillation (AF). Currently, no safety data with regard to the impact of the underlying structural heart diseases (SHD) are available. We sought to assess the risk for acute and long-term complications during CA of AF in relation to underlying SHD.

Methods and Results. We included 6,211 patients in a prospective registry undergoing CA of AF in 41 nationwide centers. All patients were divided into 4 groups according to the underlying heart disease: No SHD (69.4%), hypertensive heart disease (HHD) (12.0%), coronary artery disease (CAD) (15.1%), and cardiomyopathy (CM) (3.6%). In univariate analysis, patients with HHD had an overall complication rate of 7.28%, whereas patients without an SHD had a significantly lower rate of 6.01% (P < 0.01). Multivariate analysis revealed that HHD (adjusted odds ratio [OR]: 1.97 [95% confidence interval (CI): 1.02–3.83], P = 0.0442) and age (years; OR: 1.04 [95% CI: 1.01–1.07], P = 0.0155) were independent predictors of severe, nonfatal complications and death. Other SHD including CAD (OR: 1.48 (0.73–3.00), P = 0.2797) and CM (OR: 2.37 [0.70–7.99], P = 0.1630) failed to reach statistical significance. Male sex was protective (OR: 0.47 [95% CI: 0.27–0.81], P = 0.0062).

Conclusion. In general, CA of AF has a low number of severe complications. In our prospective registry HHD emerged as an independent predictor of severe, nonfatal complications during AF ablation but other SHD including CAD and CM did not. The influence of HHD on the complication rate should be considered in patient selection.

Introduction

Over the last decade, catheter ablation (CA) for the curative treatment of drug-refractory atrial fibrillation (AF) has undergone rapid development and expansion. An increasing demand for CA procedures calls for a better evaluation of associated complications.

Despite new technological and procedural improvements, CA of AF is still associated with significant complications. Major complications occur in 0.8–6.0% of patients.^[1–3] Only a few influencing factors, e.g., advanced age,^[4–6] coronary heart disease (CAD),^[2] and hypertrophic cardiomyopathy (CM)^[7] have been explored in detail.

We thus aimed to prospectively assess the procedure-related risk for acute and long-term complications of CA for AF in relation to underlying structural heart diseases (SHD) in a prospective multicenter registry.

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Abstract and Introduction
Methods
Results
Discussion
Conclusion
References

Table 1. Baseline Demographics
	No Structural Heart Disease	Hypertensive Heart Disease	Coronary Artery Disease	Cardiomyopathy	P Value
Patients (n)	4310 (69.4%)	743 (12.0%)	937 (15.1%)	221 (3.6%)	–
Male sex (n)	2850 (66.1%)	471 (63.4%)	722 (77.1%)	182 (82.4%)	<0.0001
Age (years)	61.0 (53.0–68.0)	66.0 (59.0–71.0)	67.0 (61.0–71.0)	57.0 (49.0–65.0)	<0.0001
Age > 75 years	2.9%	8.3%	8.3%	2.3%	<0.0001
Hypertension	50.7%	100%	73.2%	55.7%	<0.0001
Diabetes mellitus	5.6%	13.2%	14.9%	9.0%	<0.0001
Renal insufficiency	1.8%	3.8%	6.3%	5.7%	<0.0001
CHA₂DS₂-VASc score	1.4 ± 1.2	2.3 ± 1.3	3.1 ± 1.3	1.6 ± 1.4	<0.0001
Stroke history	4.5%	5.6%	6.8%	1.9%	0.09
Chronic obstructive pulmonary disease	2.0%	3.8%	4.1%	2.8%	<0.05
Peripheral vascular disease	0.5%	1.2%	3.2%	0.0%	<0.0001
Cardiomyopathy
Dilated cardiomyopathy	–	–	–	74.2%	–
Hypertrophic cardiomyopathy	–	–	–	25.8%	–
Systolic blood pressure (mmHg)	129.6 ± 15.9	137.4 ± 15.6	133.8 ± 19.6	127.4 ± 19.5	<0.0001
Diastolic blood pressure (mmHg)	78.8 ± 10.2	82.2 ± 10.0	79.3 ± 11.1	80.9 ± 11.2	<0.01
Left ventricular systolic function
>50%	95.8%	83.5%	76.5%	28.1%	<0.0001
41–50%	4.2%	13.5%	16.4%	38.9%	<0.0001
31–40%	0.0%	2.4%	5.6%	17.7%	<0.0001
≤30%	0.0%	0.6%	1.5%	15.3%	<0.0001

Table 2. Procedural Characteristics
	No Structural Heart Disease	Hypertensive Heart Disease	Coronary Artery Disease	Cardiomyopathy	P Value
Atrial fibrillation type
Paroxysmal	67.4%	58.3%	59.0%	36.9%	<0.0001
Persistent	28.0%	36.4%	35.8%	52.3%	<0.0001
Long-lasting persistent	4.6%	5.3%	5.2%	10.8%	<0.001
Rhythm during ablation
Sinus rhythm	66.9%	64.0%	64.5%	48.2%	<0.0001
Atrial fibrillation	33.1%	36.0%	35.5%	51.8%	<0.0001
1st ablation	83.1%	84.6%	84.9%	83.8%	0.49
Recurrent ablation	16.9%	15.4%	15.1%	16.2%	0.49
Ablation procedures(n)	2.3 ± 0.9	2.2 ± 0.5	2.2 ± 0.5	2.3 ± 0.6	0.75
3D-mapping system	62.5%	50.0%	55.3%	61.3%	<0.0001
CARTO^TM	58.5%	62.3%	55.5%	63.2%	0.15
EnSite NavX^TM	31.3%	27.0%	36.6%	30.9%	<0.05
Other	8.8%	9.1%	7.3%	5.9%	0.47
Catheter navigation
Manually	94.8%	95.9%	95.9%	95.3%	0.49
Hansen Sensei^TM	3.7%	2.2%	3.0%	4.7%	0.18
Stereotaxis Niobe^TM	1.5%	1.6%	1.2%	0.0%	0.39
Circumferential pulmonary vein isolation (n)	83.7%	86.8%	89.4%	89.2%	<0.0001
Segmental ostial pulmonary vein isolation (n)	15.1%	19.5%	11.0%	10.4%	<0.0001
Linear ablation lines (n)	16.7%	16.9%	14.9%	18.5%	0.48
Ablation of complex fractionated atrial electrograms (n)	10.0%	9.5%	11.7%	19.1%	<0.001

Table 3. Procedural Characteristics
	No Structural Heart Disease	Hypertensive Heart Disease	Coronary Artery Disease	Cardiomyopathy	P Value
Ablation energy source
Radiofrequency	80.7%	75.9%	82.6%	81.5%	<0.01
Cryo	18.1%	23.9%	16.4%	17.6%	<0.001
Other	1.2%	0.1%	1.0%	0.9%	0.08
Ablation catheter
Irrigated tip	74.4%	67.0%	77.3%	76.1%	<0.0001
Other	26.0%	33.2%	23.1%	23.9%	<0.0001
Max. RF power (Watts)	35.0 (30.0–40.0)	36.0 (30.0–40.0)	34.0 (30.0–40.0)	30.0 (30.0–40.0)	<0.001
Total RF duration (seconds)	2340.0 (1307.0–3420.0)	2400.0 (1365.5–3309.0)	2533.0 (1539.0–3600.0)	2934.5 (1745.0–4285.0)	<0.001
Fluoroscopy time (minutes)	27.0 (18.0–43.0)	30.0 (19.0–49.0)	30.0 (19.0–48.0)	32.0 (23.0–52.0)	<0.0001
Dose area product (cGycm²)	3248.5 (1691.5–6337.5)	3583.0 (1821.0–6790.0)	3881.5 (1998.0–7390.0)	4348.0 (2307.0–8201.0)	<0.0001
Procedure duration (minutes)	164.0 (120.0–210.0)	165.0 (120.0–210.0)	173.0 (130.0–214.0)	180.0 (140.0–230.0)	<0.0001
Peri-interventional anticoagulation
Heparin (UFH) during ablation	85.0%	74.3%	82.7%	87.6%	<0.0001
ACT measurement	87.9%	88.2%	92.6%	90.8%	<0.001
Hospital stay (days)	3.0 (2.0–5.0)	4.0 (2.0–6.0)	3.0 (2.0–5.0)	4.0 (2.0–6.0)	<0.0001

Table 4. Anticoagulation at the Time of Discharge
	No Structural Heart Disease	Hypertensive Heart Disease	Coronary Artery Disease	Cardiomyopathy	P Value
Acetylsalicylic acid (ASA; %)	7.2%	10.1%	22.6%	7.8%	0.0001
Clopidogrel (%)	1.9%	2.3%	10.7%	2.8%	<;0.0001
Warfarin (%)	90.2%	90.9%	92.4%	91.3%	0.22
Heparin (UFH; %)	6.6%	9.4%	8.0%	4.6%	<0.001
Heparin (LMWH; %)	66.1%	55.1%	64.3%	62.8%	<0.0001

Table 5. Severe, Nonfatal Complications
	Overall	No Structural Heart Disease	Hypertensive Heart Disease	Coronary Artery Disease	Cardiomyopathy	P Value
Acute myocardial infarction (%)	0.03%	0.05%	0.0%	0.0%	0.0%	0.83
Cerebrovascular stroke (%)	0.24%	0.14%	0.95%	0.22%	0.0%	<0.001
Major bleeding with intervention (%)	0.75%	0.65%	1.35%	0.87%	0.0%	0.13
Emergency cardiac surgery (%)	0.06%	0.09%	0.0%	0.0%	0.0%	0.61
Total	1.08%	0.93%	2.3%	1.09%	0.0%	<0.01

Table 6. Complication Rates Including Death
	Overall	No Structural Heart Disease	Hypertensive Heart Disease	Coronary Artery Disease	Cardiomyopathy	P Value
MACE (death, AMI; %)	0.06%	0.05%	0.0%	0.2%	0.0%	0.26
MACCE (death, AMI, stroke; %)	0.31%	0.19%	0.95%	0.43%	0.0%	<0.01
Minor, nonfatal complications (%)	2.64%	2.69%	2.42%	1.81%	3.17%	0.37
Moderate, nonfatal complications (%)	2.58%	2.39%	2.56%	3.31%	3.17%	0.48
Severe, nonfatal complications (%)	1.08%	0.93%	2.3%	1.09%	0.0%	<0.01
Fatal complications (%)	0.025%	0.0%	0.0%	0.21%	0.0%	<0.05
Total	6.33%	6.01%	7.28%	6.42%	6.34%	<0.01

Table 7. Independent Predictors for Severe, Nonfatal Complications and Death in Multivariable Logistic Regression Modela
Independent Predictor	Odds Ratio (95% CI)	P Value
Hypertensive heart disease‡	1.97 (1.02–3.83)	0.0442
Coronary artery disease‡	1.48 (0.73–3.00)	0.2797
Cardiomyopathy‡	2.37 (0.70–7.99)	0.1630
Male sex	0.47 (0.27–0.81)	0.0062
Age (years)	1.04 (1.01–1.07)	0.0155

^aModel contains the following variables: Hypertensive heart disease, coronary artery disease, cardiomyopathy, male sex, age (years), hypertension, diabetes mellitus, renal insufficiency, stroke, chronic obstructive pulmonary disease, peripheral vascular disease, device implantation; backward selection (α = 0.05) was done.
^‡Versus no structural heart disease (no SHD).

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Impact of Structural Heart Disease on the Acute Complication Rate in Atrial Fibrillation Ablation

Results From the German Ablation Registry

Abstract and Introduction

Abstract

Introduction

Tables

Tables

Tables

Tables

Tables

Tables

Tables

References

Authors and Disclosures

Authors and Disclosures

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