Structural Heart Disease Impact on AF Ablation Complications
Structural Heart Disease Impact on AF Ablation Complications
A total of 55 German electrophysiological centers agreed to participate in this prospective multicenter registry. Forty-one centers included patients undergoing CA of AF.
All patients with an age ≥ 18 years who underwent CA of AF in their respective center were enrolled between January 2007 and August 2011 after written and informed consent was obtained. Patients with a relevant valvular heart disease or undergoing atrioventricular (AV) node ablation were excluded. A total cohort of 6,211 patients was divided into 4 groups according to their underlying SHD: no SHD (n = 4,310 [69.4%]; median age = 61.0 years [53.0–68.0]; 66.1% male), hypertensive heart disease (HHD; n = 743 [12.0%], 66.0 years [59.0–71.0]; 63.4% male), CAD (n = 937 [15.1%]; 67.0 years [61.0–71.0]; 77.1% male), and CM (n = 221 [3.6%]; 57.0 years [49.0–65.0]; 82.4% male).
The mode of the CA, e.g., choice of the ablation catheter, ablation energy source, nonfluoroscopic navigation system, magnetic or remote navigation, as well as the pre- and periprocedural management were chosen at the discretion of the investigator according to the institutional standards. All ablation strategies aimed at electrical isolation of the pulmonary veins (PV) as described previously in detail.
Transthoracic echocardiography was performed routinely before and within 24 hours after ablation. In case of symptoms, e.g., hypotension, tachycardia, chest pain, painful breathing, shortness of breath after an initially normal echocardiographic study, a repeat echo was performed.
HHD was defined as structural heart disease in the presence of arterial hypertension and at least one of the following echocardiographic findings: (i) left ventricular (LV) hypertrophy with an end-diastolic interventricular septum thickness >12 mm; (ii) LV diastolic dysfunction; (iii) LV systolic dysfunction. CAD was defined as coronary atherosclerosis with or without the history of myocardial infarction and revascularization. CMs were defined as diseases of the myocardium associated with cardiac dysfunction. Ischemic CM was defined as cardiac dysfunction in the presence of CAD and those patients were assigned to the CAD group. All patients without HHD, CAD, or CM were classified to the no SHD group. All echocardiographic measurements were acquired according to previously published recommendations.
The definition of complications includes all adverse events requiring treatment, hospitalization, or resulting in fatality, which are elicited by CA of AF. Minor complications are defined as those either resolving spontaneously or without sequelae and that did not prolong the hospital stay. Minor, nonfatal complications comprise minor peripheral bleeding without intervention and AV-block 1st and 2nd degree. A major complication is a complication that results in permanent injury or death, requires intervention for treatment, or prolongs or requires hospitalization for more than 48 hours. An intervention was counted if it involved an invasive procedure, e.g., vascular or cardiac surgery, pericardiocentesis. A major complication comprises: (i) severe, nonfatal complications: acute myocardial infarction (AMI), cerebrovascular stroke, hemodynamical relevant pericardial effusion/pericardial tamponade, emergency cardiothoracic surgery, major bleeding with a fall in hemoglobin >2 g/dL and intervention; (ii) moderate, nonfatal complications: transient ischemic attack (TIA), cardiopulmonary resuscitation, peripheral aneurysm, pneumothorax, hemothorax, and AV-block 3rd degree; (iii) death. A cerebrovascular stroke was defined as a sudden focal neurological deficit confirmed on neuroimaging, or a clinical diagnosis made by a consulting neurologist. A TIA was defined as above with rapid symptom resolution within 24 hours and without tissue injury in neuroimaging. A fatal complication is a procedure-related complication leading to patient death.
The Institute for Research in Myocardial Infarction (Ludwigshafen, Germany) carried out and was responsible for project development, project management, data management and clinical monitoring, and was the central contract research organization for the study. Documentation and data management was paperless and was carried out as an Internet-based case report form system. The data acquisition of patient baseline characteristics and complications up to 30 days was performed by the treating physician or study nurses of the including hospital. A centralized 1-year follow-up via telephone was performed by the Institute for Research in Myocardial Infarction. All site information was confidential and transmitted data were encrypted with a secure socket layer. The institute also developed and described the biometric model and planned and performed all statistical analyses.
Data are shown as absolute values, percentages, means with standard deviation or medians with 0.25 quartiles and 0.75 quartiles (interquartile range). For statistical comparisons, the chi-square test was used with categorical or dichotomous variables and the nonparametric Kruskal–Wallis test with metric variables. To identify variables as independent predictors for major hospital complications, multiple logistic regression analysis was used with backward stepwise logistic regression (P <0.05). All statistical comparisons were 2-sided, with P values <0.05 being accepted as statistically significant. All analyses were performed using the Statistical Analysis System (SAS, version 9.2, SAS Institute Inc., Cary, NC, USA).
Methods
Recruiting Sites
A total of 55 German electrophysiological centers agreed to participate in this prospective multicenter registry. Forty-one centers included patients undergoing CA of AF.
Patient Population
All patients with an age ≥ 18 years who underwent CA of AF in their respective center were enrolled between January 2007 and August 2011 after written and informed consent was obtained. Patients with a relevant valvular heart disease or undergoing atrioventricular (AV) node ablation were excluded. A total cohort of 6,211 patients was divided into 4 groups according to their underlying SHD: no SHD (n = 4,310 [69.4%]; median age = 61.0 years [53.0–68.0]; 66.1% male), hypertensive heart disease (HHD; n = 743 [12.0%], 66.0 years [59.0–71.0]; 63.4% male), CAD (n = 937 [15.1%]; 67.0 years [61.0–71.0]; 77.1% male), and CM (n = 221 [3.6%]; 57.0 years [49.0–65.0]; 82.4% male).
CA Procedure
The mode of the CA, e.g., choice of the ablation catheter, ablation energy source, nonfluoroscopic navigation system, magnetic or remote navigation, as well as the pre- and periprocedural management were chosen at the discretion of the investigator according to the institutional standards. All ablation strategies aimed at electrical isolation of the pulmonary veins (PV) as described previously in detail.
Transthoracic echocardiography was performed routinely before and within 24 hours after ablation. In case of symptoms, e.g., hypotension, tachycardia, chest pain, painful breathing, shortness of breath after an initially normal echocardiographic study, a repeat echo was performed.
Definition of Underlying Heart Disease
HHD was defined as structural heart disease in the presence of arterial hypertension and at least one of the following echocardiographic findings: (i) left ventricular (LV) hypertrophy with an end-diastolic interventricular septum thickness >12 mm; (ii) LV diastolic dysfunction; (iii) LV systolic dysfunction. CAD was defined as coronary atherosclerosis with or without the history of myocardial infarction and revascularization. CMs were defined as diseases of the myocardium associated with cardiac dysfunction. Ischemic CM was defined as cardiac dysfunction in the presence of CAD and those patients were assigned to the CAD group. All patients without HHD, CAD, or CM were classified to the no SHD group. All echocardiographic measurements were acquired according to previously published recommendations.
Definition of Complications
The definition of complications includes all adverse events requiring treatment, hospitalization, or resulting in fatality, which are elicited by CA of AF. Minor complications are defined as those either resolving spontaneously or without sequelae and that did not prolong the hospital stay. Minor, nonfatal complications comprise minor peripheral bleeding without intervention and AV-block 1st and 2nd degree. A major complication is a complication that results in permanent injury or death, requires intervention for treatment, or prolongs or requires hospitalization for more than 48 hours. An intervention was counted if it involved an invasive procedure, e.g., vascular or cardiac surgery, pericardiocentesis. A major complication comprises: (i) severe, nonfatal complications: acute myocardial infarction (AMI), cerebrovascular stroke, hemodynamical relevant pericardial effusion/pericardial tamponade, emergency cardiothoracic surgery, major bleeding with a fall in hemoglobin >2 g/dL and intervention; (ii) moderate, nonfatal complications: transient ischemic attack (TIA), cardiopulmonary resuscitation, peripheral aneurysm, pneumothorax, hemothorax, and AV-block 3rd degree; (iii) death. A cerebrovascular stroke was defined as a sudden focal neurological deficit confirmed on neuroimaging, or a clinical diagnosis made by a consulting neurologist. A TIA was defined as above with rapid symptom resolution within 24 hours and without tissue injury in neuroimaging. A fatal complication is a procedure-related complication leading to patient death.
Registry Management
The Institute for Research in Myocardial Infarction (Ludwigshafen, Germany) carried out and was responsible for project development, project management, data management and clinical monitoring, and was the central contract research organization for the study. Documentation and data management was paperless and was carried out as an Internet-based case report form system. The data acquisition of patient baseline characteristics and complications up to 30 days was performed by the treating physician or study nurses of the including hospital. A centralized 1-year follow-up via telephone was performed by the Institute for Research in Myocardial Infarction. All site information was confidential and transmitted data were encrypted with a secure socket layer. The institute also developed and described the biometric model and planned and performed all statistical analyses.
Statistical Analysis
Data are shown as absolute values, percentages, means with standard deviation or medians with 0.25 quartiles and 0.75 quartiles (interquartile range). For statistical comparisons, the chi-square test was used with categorical or dichotomous variables and the nonparametric Kruskal–Wallis test with metric variables. To identify variables as independent predictors for major hospital complications, multiple logistic regression analysis was used with backward stepwise logistic regression (P <0.05). All statistical comparisons were 2-sided, with P values <0.05 being accepted as statistically significant. All analyses were performed using the Statistical Analysis System (SAS, version 9.2, SAS Institute Inc., Cary, NC, USA).
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