ABSTRACT
BACKGROUND: Pulmonary vein isolation (PVI) via catheter ablation is an approved therapy for patients with drug-refractory and symptomatic atrial fibrillation (AF). Furthermore, cryoballoon is now considered to be as effective as focal radiofrequency catheter ablation. This study examines the second-generation cryoballoon performance in a US multicenter review of real-world practices. METHODS: By retrospective chart collections, the long-term efficacy and safety of the cryoballoon procedure were assessed in 15 US centers. All patients had a history of drug-refractory symptomatic paroxysmal AF and were treated with a cryoballoon PVI strategy at the index ablation. RESULTS: Four hundred fifty-two patients were evaluated, and acute PVI was achieved in 99% of patients by cryoballoon catheter ablation. In 0.88% of patients (4/452), an additional focal ablation catheter was used to achieve acute PVI during the ablation procedure. Average procedure time was 128 (range 82 to 260) min, using an average of 17 (range 1 to 19) min of fluoroscopy. The most frequent adverse event was transient phrenic nerve injury (1.5%; 7/452 patients) which all resolved by the end of the procedure with no diaphragmatic dysfunction at discharge. There were no strokes, transient ischemic attacks, cardiac tamponade, atrioesophageal fistulas, or deaths during the study. At the 12-month efficacy endpoint, single-procedure success of freedom from atrial arrhythmia was 87% (393/452 patients). CONCLUSIONS: This real-world examination of the US practice demonstrates that second-generation cryoballoon ablation by PVI strategy is safe and effective among patients with paroxysmal AF.
Subject(s)
Atrial Fibrillation/surgery , Catheter Ablation/methods , Cryosurgery/instrumentation , Pulmonary Veins/surgery , Adult , Aged , Aged, 80 and over , Atrial Fibrillation/diagnosis , Cohort Studies , Cryosurgery/methods , Electrocardiography/methods , Equipment Design , Female , Follow-Up Studies , Humans , Male , Middle Aged , Minimally Invasive Surgical Procedures/methods , Patient Safety/statistics & numerical data , Prognosis , Retrospective Studies , Risk Assessment , Severity of Illness Index , Treatment OutcomeABSTRACT
A small (< 6 cm(3) in volume or 1.8 cm in diameter), uncomplicated iatrogenic femoral artery pseudoaneurysm in a reliable patient not requiring anticoagulation can be safely observed with weekly physical examinations and ultrasound evaluations until full thrombosis is documented. The patient should be informed that any symptoms or complications should be reported to a physician immediately. A pseudoaneurysm associated with limb ischemia, severe infection, neurologic deficit, skin necrosis, rapid expansion, or hemorrhage should be treated surgically. Also, surgery is recommended if less invasive treatment strategies have failed, or if a planned surgical procedure involving the groin is anticipated. Given its high success rate, low complication rate, and cost-effectiveness, ultrasound-guided thrombin injection should be considered as first-line treatment for uncomplicated iatrogenic femoral pseudoaneurysm. Ultrasound-guided compression repair is an effective alternative to thrombin injection, especially in institutions that have little or no experience with thrombin injection. Alternative treatment strategies, such as percutaneous endovascular stenting and perfusion ballooning, are generally not recommended as first-line treatment options, because they have not been studied as extensively as ultrasound-guided compression repair or thrombin injection. If no other options are available, however, these alternative approaches may be appropriate in certain clinical situations.
