What is the clinical evidence from this study?

Study design: Cohort. Population: Atrial fibrillation (n=1435). Intervention: Vascular ultrasound for venipuncture guidance and post-procedural evaluation vs. No vascular ultrasound guidance or evaluation. Primary outcome: Major clinical complications (requiring intervention and/or prolonged stay) (p=0.02).

July 11, 2018

Value of ultrasound for access guidance and detection of subclinical vascular complications in the setting of atrial fibrillation cryoballoon ablation

Key Result

Ultrasound-guided venipuncture was associated with a near-to-zero risk of major clinical vascular complications compared to no ultrasound guidance (0% vs 1.7%, P=0.02) during cryoballoon ablation.

Study Design

Type

Cohort (n=1,435)

Multicenter

Yes

Structured PICO

Does ultrasound-guided venipuncture and post-procedural evaluation reduce vascular complications in patients undergoing cryoballoon ablation for atrial fibrillation?

Population

1435 consecutive patients undergoing cryoballoon (CB) ablation for atrial fibrillation (AF) requiring insertion of a 15 Fr sheath in the femoral vein

Intervention

Ultrasound (US) guidance for venipuncture and post-procedural evaluation (US +/+ group, n=300) or post-procedural evaluation only (US -/+ group, n=265)

Comparator

No ultrasound guidance for venipuncture or post-procedural evaluation (US -/- group, n=870)

Outcome

Major clinical complications (requiring intervention and/or prolonged stay) and major US events (evidence of inadvertent artery puncture/cannulation)safety

Routine use of ultrasound for venous access guidance during AF cryoballoon ablation significantly reduces vascular complications to near zero.

Main Result

Absolute Event Rate: 0% vs 1.7%

p-value: p=0.02

Abstract

AIMS: Vascular complications are the most common complications of atrial fibrillation (AF) ablation. Cryoballoon (CB) ablation for AF needs the insertion of a large 15 Fr sheath in the femoral vein. Our aim was to investigate the impact of vascular ultrasound (US) in guiding access and evaluating post-procedural subclinical complications in a large, multi-centre patient cohort that underwent CB ablation. METHODS AND RESULTS: A total cohort of 1435 consecutive patients were subdivided in 870 US -/-, 265 US -/+, and 300 US +/+ patients depending on US performance for: venipuncture guidance/post-procedural evaluation. Major clinical complications (requiring intervention and/or prolonged stay) were assessed. Irrespective of the clinical status, major US events were systematically determined in the subgroups with US evaluation 1 day post-procedure, if evidence of inadvertent artery puncture/cannulation (communication between artery and collection or artery-vein, regardless of the thrombosis state). Major clinical events were encountered in 1.7% (15/870), 1.1% (3/265), and 0% of patients in US -/-, US -/+, and US +/+ group, respectively (P = 0.02 between US -/- and US +/+ group). In the US -/- group, 5/10 (50%) of pseudo-aneurysms were diagnosed during readmission after a mean of 24 ± 11 days post-procedure. No delayed presentation was seen in the US -/+ group. Major US events during the US protocol post-procedure were seen in 3.8% (10/265) vs. 0.3% (1/300) of patients in US -/+ vs. US +/+ group, respectively, P = 0.004. CONCLUSION: US-guided venipuncture was associated with a near-to-zero risk of vascular complications in our patients undergoing CB ablation.

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