Extended Data Table 5 All adverse events related or possibly related to procedure or device

From: Dual-energy lattice-tip ablation system for persistent atrial fibrillation: a randomized trial

Adverse event preferred terma

No. of events (no. of patients, % patients)

Investigational arm (n = 212)

Control arm (n = 208)

Total

31 (29, 13.7%)

43 (32, 15.4%)

Abdominal pain

1 (1, 0.5%)

0 (0, 0.0%)

Anesthetic complication

0 (0, 0.0%)

1 (1, 0.5%)

Arteriovenous fistula

0 (0, 0.0%)

1 (1, 0.5%)

Atrial fibrillation

0 (0, 0.0%)

1 (1, 0.5%)

Body temperature increased

0 (0, 0.0%)

2 (2, 1.0%)

Bradycardia

2 (2, 0.9%)

0 (0, 0.0%)

Chest discomfort

0 (0, 0.0%)

1 (1, 0.5%)

Chest pain

0 (0, 0.0%)

1 (1, 0.5%)

Chronic obstructive pulmonary disease

1 (1, 0.5%)

0 (0, 0.0%)

Cough

0 (0, 0.0%)

1 (1, 0.5%)

Cyst

0 (0, 0.0%)

1 (1, 0.5%)

Esophageal mucosa erosion

0 (0, 0.0%)

1 (1, 0.5%)

Fatigue

2 (2, 0.9%)

0 (0, 0.0%)

Hypertensive urgency

1 (1, 0.5%)

0 (0, 0.0%)

Hematuria

0 (0, 0.0%)

1 (1, 0.5%)

Hemoptysis

1 (1, 0.5%)

0 (0, 0.0%)

Hiatal hernia with gastritis

1 (1, 0.5%)

0 (0, 0.0%)

Hypervolemia

4 (4, 1.9%)

8 (8, 3.8%)

Hypotension

0 (0, 0.0%)

1 (1, 0.5%)

Hypoxia

0 (0, 0.0%)

1 (1, 0.5%)

Lip injury

1 (1, 0.5%)

0 (0, 0.0%)

Myocardial infarction

0 (0, 0.0%)

1 (1, 0.5%)

Non-cardiac chest pain

1 (1, 0.5%)

0 (0, 0.0%)

Ocular discomfort

0 (0, 0.0%)

1 (1, 0.5%)

Pericardial effusion/constrictionb

1 (1, 0.5%)

0 (0, 0.0%)

Pericarditis

0 (0, 0.0%)

3 (3, 1.4%)

Pharyngitis

1 (1, 0.5%)

0 (0, 0.0%)

Phlebitis

1 (1, 0.5%)

0 (0, 0.0%)

Phrenic nerve injuryc

2 (2, 0.9%)

0 (0, 0.0%)

Pleuritic pain

0 (0, 0.0%)

1 (1, 0.5%)

Pneumonia

0 (0, 0.0%)

1 (1, 0.5%)

Productive cough

0 (0, 0.0%)

1 (1, 0.5%)

Rash

2 (2, 0.9%)

0 (0, 0.0%)

Raynaud’s phenomenon

0 (0, 0.0%)

1 (1, 0.5%)

Sepsis

2 (2, 0.9%)

1 (1, 0.5%)

Skin irritation

0 (0, 0.0%)

1 (1, 0.5%)

Vascular access site hematoma

3 (3, 1.4%)

3 (3, 1.4%)

Vascular access site hemorrhage

2 (2, 0.9%)

3 (3, 1.4%)

Vascular access site irritation

0 (0, 0.0%)

1 (1, 0.5%)

Vascular access site laceration

0 (0, 0.0%)

1 (1, 0.5%)

Vascular access site mass

0 (0, 0.0%)

1 (1, 0.5%)

Visual impairment

0 (0, 0.0%)

2 (2, 1.0%)

Weight increased

2 (2, 0.9%)

0 (0, 0.0%)

  1. a Results of the neurological substudy are reported separately in Extended Data Table 8.
  2. b A delayed effusion occurred at day 264 after index procedure in a patient who had a history of large pericardial effusion before the ablation.
  3. c Two transient phrenic nerve injuries occurred in the investigational arm, and both patients documented full resolution based on a sniff test.
Back to article page