Gastroparesis as a Complication of Atrial Fibrillation Ablation Tolga Aksu, MDa,*, Sukriye Golcuk, MDb, Tumer E. Guler, MDa, Kıvanç Yalin, MDc, and Ismail Erden, MDa Percutaneous catheter ablation is a safe and effective treatment for symptomatic drugresistant atrial fibrillation (AF). Gastroparesis is a little known complication of AF ablation. We aimed to evaluate the frequency of gastroparesis in the patients who underwent catheter ablation for AF by cryoballoon (CB) or radiofrequency (RF) and to define risk factors for gastroparesis. In all, 104 patients were treated with pulmonary vein (PV) isolation with 2 different technologies: CB in 58 patients (group 1) and open-irrigated tip RF catheter in 46 patients (group 2). Gastroparesis was seen in 7 cases (6 cases in group 1 and 1 case in group 2, respectively). The complaints related with gastroparesis began during the procedure in 4 of 6 patients of group 1. The other 3 patients admitted to our outpatient clinic with similar complaints within 72 to 96 hours after the procedure. For gastroparesis cases of group 1, mean minimal CB temperature on inferior PVs was lower and left atrium diameter was smaller. Management was conservative, and the patients have no residual symptoms at 6-month follow-up. The only patient still demonstrating residual symptoms during follow-up was in group 2. Although, clinically manifest gastroparesis is quite common with CB ablation, the process is generally reversible. However, damage may not be as reversible with RF ablation. In conclusion, during cryoablation, lower temperatures on inferior PVs and small left atrium size may be associated with increased risk of gastroparesis, and fluoroscopic guidance may be useful to avoid this complication. Ó 2015 Elsevier Inc. All rights reserved. (Am J Cardiol 2015;-:-e-)
Atrial fibrillation (AF) is the most common cardiac arrhythmia, with an estimated prevalence of 1% to 3%.1,2 The pulmonary vein isolation (PVI) still remains the cornerstone of AF ablation procedures.3 Cryoballoon (CB) ablation and radiofrequency (RF) catheter ablation have become effective and widely accepted tools for PVI.4,5 Gastroparesis is a syndrome characterized by delayed gastric emptying in absence of mechanical obstruction of the stomach.6 The disorder is associated with symptoms such as epigastric discomfort, abdominal pain, nausea, vomiting, and bloating.6,7 It is postulated that gastroparesis associated with AF ablation may be caused by periesophageal vagal nerve injury, and it was reported as a complication of RF catheter ablation in the patients with AF.8,9 However, the frequency and the risk factors of gastroparesis as a complication of CB ablation were not clearly elucidated in the literature. The main objectives of this study were to define the factors associated with the occurrence of gastroparesis in PVI procedures using cryoenergy or RF energy.
a Department of Cardiology, Derince Education and Research Hospital, Kocaeli, Turkey; bDepartment of Cardiology, Faculty of Medicine, Koc University, Istanbul, Turkey; and cCardiology Clinic, Bursa State Hospital, Bursa, Turkey. Manuscript received February 21, 2015; revised manuscript received and accepted March 19, 2015. See page 5 for disclosure information. *Corresponding author: Tel: þ90-531-990-3278; fax: þ90-262-3178000. E-mail address: [email protected] (T. Aksu).
0002-9149/15/$ - see front matter Ó 2015 Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.amjcard.2015.03.045
Methods Consecutive patients with symptomatic, drug-refractory paroxysmal, or persistent AF who underwent PVI were included in this prospective study. Patients were classified as having paroxysmal or persistent AF according to the current guidelines.3 Patients underwent PVI with either CB catheter (58 patients, group 1) or with conventional openirrigated tip RF catheter (46 patients, group 2) randomly. Exclusion criteria were intracardiac thrombi documented by transesophageal echocardiography, severe systolic heart failure (left ventricular ejection fraction 55 mm), New York Heart Association class IV, longstanding persistent AF, previous AF ablation procedure, previous abdominal surgical procedures, history of either acute or chronic neuropathies, use of drugs that affect gastrointestinal motility, inadequate follow-up, anticoagulation, and/or inability to provide informed consent. Written informed consent was obtained from all patients before the procedure. The local ethical committee approved the study. All antiarrhythmic drugs were discontinued 5 half-lives before the procedure. All procedures were performed under minimal sedation with midazolam. A single or double transseptal puncture was performed according to the use of a conventional circumferential mapping catheter (Inquiry Optima PLUS Catheter; St. Jude Medical, St. Paul, MN) or the customized mapping catheter (Achieve; Medtronic, Minneapolis, Minnesota) in both groups. For group 1, positioning of the second-generation 28-mm CB catheter (Arctic Front Advance; Medtronic) was achieved using the guidewire and the 12Fr-steerable www.ajconline.org
2
The American Journal of Cardiology (www.ajconline.org)
Figure 1. Fluoroscopic view of enlarged and air-filled stomach. Panel A demonstrates early phase of gastroparesis, whereas panels B to F show progressive gastric enlargement because of decreased peristaltic activity.
sheath (Flexcath; Medtronic). Although delivering cryoenergy to right pulmonary veins (PVs), a 6F decapolar coronary sinus catheter or a quadripolar diagnostic catheter were positioned in the superior vena cava for phrenic nerve stimulation. Before each freeze, grade of occlusion (semiquantitative scale from 1 [poor occlusion] to 4 [perfect occlusion]) was quantified with an injection of contrast medium.10 After confirmation of PV occlusion by contrast injection, the 240-second freezing cycle was initiated. After 2 freezing cycles, PVI was assessed by circumferential mapping catheter. Isolation of PVs were defined as the presence of both entrance and exit block. For group 2, an open-irrigated tip catheter with a 3.5-mm-tip electrode (ThermoCool; Biosense Webster, Diamond Bar, CA) was used in conjunction with a 3-dimensional electroanatomic mapping system (Ensite, NavX Fusion, St. Jude Medical). RF energy was delivered with power of up to 35 W and a maximum temperature of 43 C. Ablation was performed circumferentially, guided by a conventional circular mapping catheter, near the antrum of each PV. The esophageal probe was not used to monitor temperature in the RF group. Instead, RF power was limited to 20 to 25 W on the posterior wall. For the patients with paroxysmal AF, the electrophysiological end point was the achievement of a bidirectional conduction block between the left atrium (LA) and PVs. We used the creation of complete continuous circumferential lesions around the ipsilateral veins as an anatomical end point in the patients with persistent AF. During the procedure, gastroparesis was suspected in the present of following symptoms: epigastric discomfort, abdominal pain, heartburn, bloating, nausea, or vomiting, and all symptomatic patients were prospectively evaluated by fluoroscopy for an air-filled stomach or air fluid level in
Table 1 Baseline characteristics of the patients in two groups Variables Age (years) Female Body Mass Index (kg/m2) Diabetes mellitus Hypertension Coronary Artery Disease Smoker Duration of AF (years) Persistent AF LA diameter (mm) LVEF (%) CHA2DS2-VASC score EHRA score
All patients n¼104
Group 1 n¼58
Group 2 n¼46
P
5712 53 (51%) 253.7 19 (18%) 48 (46%) 15 (14%) 44 (45%) 3.22.7 14 (13%) 424.9 585.8 1.41.2 2.50.6
5512 29 (50%) 253.9 10 (17%) 25 (43%) 8 (13%) 24 (41%) 3.92.6 —— 414.5 594.9 1.41.2 2.50.6
5910 24 (52%) 253.9 9 (20%) 23 (50%) 7 (15%) 20 (43%) 4.52.8 14 (30%) 445.0 576.5 1.31.2 2.40.54
0.145 0.663 0.881 0.763 0.337 0.774 0.792 0.304 —— 0.025 0.549 0.812 0.781
Data are expressed as mean SD or as number (percentage). AF ¼ atrial fibrillation; EHRA ¼ European Heart Rhythm Association; LA ¼ left atrium; LVEF ¼ left ventricular ejection fraction; SD ¼ standard deviation.
the fundus of an enlarged fluid-filled stomach (Figure 1). The patients showing an air-filled stomach or air fluid level in the fundus of an enlarged fluid-filled stomach on fluoroscopy were evaluated by gastric emptying scintigraphy (GES) to confirm the diagnosis. After the procedure, all patients were comprehensively questioned for the following symptoms: acute onset of characteristic prolonged symptoms of gastric delayed emptying, such as nausea, vomiting, postprandial fullness, bloating, constipation, or epigastric pain. All symptomatic patients were prospectively
Arrhythmias and Conduction Disturbances/Gastroparesis After Atrial Fibrillation Ablation
3
Table 2 Procedure-related data in group 1 (n ¼ 58) Variable Minimal Temperature (C )
Total (n¼58)
Gastroparesis (-) (n¼52)
Gastroparesis (þ) (n¼6)
P
-492.4 -483.9 -513.1 -453.6 3.80.3 3.70.4 3.90.1 3.80.3 8.41.4 8.71.7 8.20.8 103.3 2.10.4 2.20.6 2.00.2 2.81.2
-492.5 -472.7 -513.2 -453.3 3.70.3 3.80.3 3.90.1 3.80.3 8.41.4 8.81.8 8.20.7 9.93.2 2.10.4 2.30.6 2.00.3 2.71.2
-502.0 -554.8 -501.0 -501.5 3.40.5 3.20.4 3.90.1 3.70.4 8.50.9 8.41.1 8.80.8 123.8 2.20.4 2.10.3 2.50.3 3.21.2
0.430
Atrial fibrillation (AF) is the most common cardiac arrhythmia, with an estimated prevalence of 1% to 3%.1,2 The pulmonary vein isolation (PVI) still remains the cornerstone of AF ablation procedures.3 Cryoballoon (CB) ablation and radiofrequency (RF) catheter ablation have become effective and widely accepted tools for PVI.4,5 Gastroparesis is a syndrome characterized by delayed gastric emptying in absence of mechanical obstruction of the stomach.6 The disorder is associated with symptoms such as epigastric discomfort, abdominal pain, nausea, vomiting, and bloating.6,7 It is postulated that gastroparesis associated with AF ablation may be caused by periesophageal vagal nerve injury, and it was reported as a complication of RF catheter ablation in the patients with AF.8,9 However, the frequency and the risk factors of gastroparesis as a complication of CB ablation were not clearly elucidated in the literature. The main objectives of this study were to define the factors associated with the occurrence of gastroparesis in PVI procedures using cryoenergy or RF energy.
a Department of Cardiology, Derince Education and Research Hospital, Kocaeli, Turkey; bDepartment of Cardiology, Faculty of Medicine, Koc University, Istanbul, Turkey; and cCardiology Clinic, Bursa State Hospital, Bursa, Turkey. Manuscript received February 21, 2015; revised manuscript received and accepted March 19, 2015. See page 5 for disclosure information. *Corresponding author: Tel: þ90-531-990-3278; fax: þ90-262-3178000. E-mail address: [email protected] (T. Aksu).
0002-9149/15/$ - see front matter Ó 2015 Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.amjcard.2015.03.045
Methods Consecutive patients with symptomatic, drug-refractory paroxysmal, or persistent AF who underwent PVI were included in this prospective study. Patients were classified as having paroxysmal or persistent AF according to the current guidelines.3 Patients underwent PVI with either CB catheter (58 patients, group 1) or with conventional openirrigated tip RF catheter (46 patients, group 2) randomly. Exclusion criteria were intracardiac thrombi documented by transesophageal echocardiography, severe systolic heart failure (left ventricular ejection fraction 55 mm), New York Heart Association class IV, longstanding persistent AF, previous AF ablation procedure, previous abdominal surgical procedures, history of either acute or chronic neuropathies, use of drugs that affect gastrointestinal motility, inadequate follow-up, anticoagulation, and/or inability to provide informed consent. Written informed consent was obtained from all patients before the procedure. The local ethical committee approved the study. All antiarrhythmic drugs were discontinued 5 half-lives before the procedure. All procedures were performed under minimal sedation with midazolam. A single or double transseptal puncture was performed according to the use of a conventional circumferential mapping catheter (Inquiry Optima PLUS Catheter; St. Jude Medical, St. Paul, MN) or the customized mapping catheter (Achieve; Medtronic, Minneapolis, Minnesota) in both groups. For group 1, positioning of the second-generation 28-mm CB catheter (Arctic Front Advance; Medtronic) was achieved using the guidewire and the 12Fr-steerable www.ajconline.org
2
The American Journal of Cardiology (www.ajconline.org)
Figure 1. Fluoroscopic view of enlarged and air-filled stomach. Panel A demonstrates early phase of gastroparesis, whereas panels B to F show progressive gastric enlargement because of decreased peristaltic activity.
sheath (Flexcath; Medtronic). Although delivering cryoenergy to right pulmonary veins (PVs), a 6F decapolar coronary sinus catheter or a quadripolar diagnostic catheter were positioned in the superior vena cava for phrenic nerve stimulation. Before each freeze, grade of occlusion (semiquantitative scale from 1 [poor occlusion] to 4 [perfect occlusion]) was quantified with an injection of contrast medium.10 After confirmation of PV occlusion by contrast injection, the 240-second freezing cycle was initiated. After 2 freezing cycles, PVI was assessed by circumferential mapping catheter. Isolation of PVs were defined as the presence of both entrance and exit block. For group 2, an open-irrigated tip catheter with a 3.5-mm-tip electrode (ThermoCool; Biosense Webster, Diamond Bar, CA) was used in conjunction with a 3-dimensional electroanatomic mapping system (Ensite, NavX Fusion, St. Jude Medical). RF energy was delivered with power of up to 35 W and a maximum temperature of 43 C. Ablation was performed circumferentially, guided by a conventional circular mapping catheter, near the antrum of each PV. The esophageal probe was not used to monitor temperature in the RF group. Instead, RF power was limited to 20 to 25 W on the posterior wall. For the patients with paroxysmal AF, the electrophysiological end point was the achievement of a bidirectional conduction block between the left atrium (LA) and PVs. We used the creation of complete continuous circumferential lesions around the ipsilateral veins as an anatomical end point in the patients with persistent AF. During the procedure, gastroparesis was suspected in the present of following symptoms: epigastric discomfort, abdominal pain, heartburn, bloating, nausea, or vomiting, and all symptomatic patients were prospectively evaluated by fluoroscopy for an air-filled stomach or air fluid level in
Table 1 Baseline characteristics of the patients in two groups Variables Age (years) Female Body Mass Index (kg/m2) Diabetes mellitus Hypertension Coronary Artery Disease Smoker Duration of AF (years) Persistent AF LA diameter (mm) LVEF (%) CHA2DS2-VASC score EHRA score
All patients n¼104
Group 1 n¼58
Group 2 n¼46
P
5712 53 (51%) 253.7 19 (18%) 48 (46%) 15 (14%) 44 (45%) 3.22.7 14 (13%) 424.9 585.8 1.41.2 2.50.6
5512 29 (50%) 253.9 10 (17%) 25 (43%) 8 (13%) 24 (41%) 3.92.6 —— 414.5 594.9 1.41.2 2.50.6
5910 24 (52%) 253.9 9 (20%) 23 (50%) 7 (15%) 20 (43%) 4.52.8 14 (30%) 445.0 576.5 1.31.2 2.40.54
0.145 0.663 0.881 0.763 0.337 0.774 0.792 0.304 —— 0.025 0.549 0.812 0.781
Data are expressed as mean SD or as number (percentage). AF ¼ atrial fibrillation; EHRA ¼ European Heart Rhythm Association; LA ¼ left atrium; LVEF ¼ left ventricular ejection fraction; SD ¼ standard deviation.
the fundus of an enlarged fluid-filled stomach (Figure 1). The patients showing an air-filled stomach or air fluid level in the fundus of an enlarged fluid-filled stomach on fluoroscopy were evaluated by gastric emptying scintigraphy (GES) to confirm the diagnosis. After the procedure, all patients were comprehensively questioned for the following symptoms: acute onset of characteristic prolonged symptoms of gastric delayed emptying, such as nausea, vomiting, postprandial fullness, bloating, constipation, or epigastric pain. All symptomatic patients were prospectively
Arrhythmias and Conduction Disturbances/Gastroparesis After Atrial Fibrillation Ablation
3
Table 2 Procedure-related data in group 1 (n ¼ 58) Variable Minimal Temperature (C )
Total (n¼58)
Gastroparesis (-) (n¼52)
Gastroparesis (þ) (n¼6)
P
-492.4 -483.9 -513.1 -453.6 3.80.3 3.70.4 3.90.1 3.80.3 8.41.4 8.71.7 8.20.8 103.3 2.10.4 2.20.6 2.00.2 2.81.2
-492.5 -472.7 -513.2 -453.3 3.70.3 3.80.3 3.90.1 3.80.3 8.41.4 8.81.8 8.20.7 9.93.2 2.10.4 2.30.6 2.00.3 2.71.2
-502.0 -554.8 -501.0 -501.5 3.40.5 3.20.4 3.90.1 3.70.4 8.50.9 8.41.1 8.80.8 123.8 2.20.4 2.10.3 2.50.3 3.21.2
0.430
