Patients (n = 35)
Age (years)
72 ± 4
Male subjects
28/35 (79 %)
AF history (months)
66 ± 36
Paroxysmal AF (%)/Persistent AF (%)
28 (80 %)/7 (20 %)
LV ejection fraction, %
54 ± 7
Hypertension, %
21/35 (60 %)
Genetic bleeding disorders
7(20 %); 3 von Willebrandt; 4 Haemophilia
Previous stroke/TIA
30/35 (86 %) (26 during OAT)
Diabetes
15/35 (43 %)
Contraindication to VKA, due to:
6/35 (17 %)
– Intracranial bleeding
2
– Profuse intestinal bleeding
4
CHA2DS2-VASc > 2
35 (100 %)
HAS-BLED ≥ 2
13 (37 %)
Thirty-five consecutive patients (mean age 72 ± 4 male 28) were included in our prospective, feasibility study. Cryoenergy was chosen as the ablative approach to use. The clinical characteristics are reported in Table 17.1. Twenty-eight patients (80 %) had paroxysmal AF and 7 patients (20 %) early persistent AF (≤6 months duration). The median CHA2DS2-VASc score was 3 and HAS-BLED score was 3. Seven patients (2 %) had well-established inherited bleeding disorders (3 patients with von Willebrand type two disorder and the remaining 4 patients with Haemophilia type B). Thirty patients (86 %) had a previous stroke (26 patients while on oral anticoagulation treatment). Besides the 7 patients with inherited bleeding disorders, contraindication to a continuous vitamin K antagonist (VKA) therapy was ascertained in additional 6 patients. In these patients, intracranial bleeding (2 patients) or profuse intestinal hemorrhage (4 patients) prevented reestablishing anticoagulation. Furthermore, 8 patients (23 %) (3 patients among those with bleeding disorders and 5 among those major gastrointestinal bleeding) had both major bleeding and cerebral ischemic events (transient ischemic attack).
Procedural Parameters (Table 17.2)
Table 17.2
Procedural and periprocedural parameters
Procedure (%) | |
Cryoisolation PV | 34/35 (97 %) |
RF | 1 (3 %) |
Device (%) | 25 (71 %) |
Amplatz | 10 (29 %) |
Watchman | |
Size mm (%) | |
Amplatz : | 11 (44 %) |
24 | 12 (48 %) |
26 | 2 (8 %) |
30 | |
Watchman: | 6 (60 %) |
24 | 3 (30 %) |
27 | 1 (10 %) |
30 | 218 ± 34 |
Procedure time, min | 45 ± 10 |
Fluoroscopy time, min | 174 ± 32 |
Cryoablation time, min | 44 ± 12 |
LAA closure time, min | |
TEE n (%) | 35 (100 %) |
Successful occlusion | 5 (14 %) |
Residual leakage (≤3 mm) | 3 (8 %) |
Slight pericardial effusion | |
Complications n (%) | 0 (0 %) |
Pericardial effusion required drainage | 0 (0 %) |
Device embolization | 0 (0 %) |
Stroke | 3 (8 %) |
Vascular events (bleedings, groin haematoma, pseudoaneurism, …) |
The mean procedural time was 174 ± 32 min for Cryoablation and 44 ± 12 min for LAA occlusion. Therefore, the overall procedural time was 218 ± 34 min. The fluoroscopic time for the ablation procedure was 36 ± 11 and 9 ± 3 min for LAA occlusion. The entire procedure was performed under general anesthesia.
Cryoballoon Pulmonary Vein Isolation
In 35 patients, a total number of 132 PVs were identified, including a left common PV in 8 patients. In the majority of cases, the 28 mm size balloon was used. The endpoint of the procedure, i.e., the complete isolation of all PVs was achieved in 34 out of 35 patients (97 %). In one patient, treated with the first Cryoballoon generation, the right inferior PV was not successfully occluded and, therefore, PV isolation was then achieved through two pulses of radiofrequency applications. Specific Cryoballoon procedure-related complications occurred in 2 patients with transient phrenic nerve palsy, while ablating at the right superior PV; this did not prevent from completing the procedure with the closure of LAA. The complete resolution of the phrenic nerve injury was demonstrated in both patients by day 24 and 60, respectively.
LAA Occlusion
Occluder devices for LAA were implanted under fluoroscopy and TEE guidance right after the PV cryoisolation was concluded. Once the size and shape of the LAA were determined by performing selected angiograms and TEE measurements, the chosen device, ACP or WATCHMAN was implanted. Successful implantation occurred for each device without major adverse event. The mean size of LAA device was 24 mm; in 5 patients a minimal residual flow (between 3 and 5 mm: two ACP and three WATCHMAN devices, respectively) was confirmed at the end of the procedure. Only in 3 patients, small pericardial effusion was detected at the end of the procedure, with no need of drainage. In additional 3 patients, a groin hematoma developed and in 1 patient arteriovenous fistula developed 24 h later, requiring surgical repair in the following days.
Follow-up (Table 17.3)
Table 17.3
Follow-up
Patients (n = 35) | |
|---|---|
Months | 14 ± 8 |
Arrhythmia recurrence | 10/35 (28 %) |
Redo-ablation | 5/35 (14 %) |
TEE evaluation | |
3 months, complete sealing | 30/35 (86 %) |
3 months, minimal leaking (<5 mm) | 5/35 (14 %) |
12 months, complete sealing | 32/35 (91 %) |
Stroke/TIA | 0/35 (0 %) |
Device embolization/device thrombus | 0/35 (0 %) |
VKA off | 30/35 (86 %) |
Death | 0/35 (0 %) |
Arrhythmia Recurrence
During follow-up (14 ± 8 months), atrial arrhythmias (AF or atrial flutter/tachycardia) occurred in 10 (28 %) of the patients. In half of them a redo procedure was then successfully performed, while 3 patients developed persistent AF and refused to undergo an additional ablation. The redo-ablation procedure was performed by using Cryoenergy, revealing PV-LA re-conduction in all patients. The presence of the occluding device did not affect the redo-ablation. The remaining 2 patients remained on antiarrhythmic drugs with still paroxysmal atrial arrhythmias.
LAA Mechanical Closure
In each patient, TEE evaluation was established at 1, 3, and 12 months. Thirty patients (86 %) had perfect sealing at 90 days and the remaining 5 patients (14 %) had a persistent minimal residual flow (<5 mm) at 90 days, and 2 of them had successful sealing at 1 year while the remaining 3 patients still had residual flow. In 13 patients (37 %) (those who were known to have inherited disorders and previous cerebral and gastrointestinal hemorrhage) VKA therapy was immediately discontinued and antiplatelet therapy started at 90 days. In additional 6 patients (17 %), due to patients’ cardiologist’s preference, NOACs treatment (dabigatran in 4 and rivaroxaban in 2 patients, respectively) was started after the procedure and then discontinued within 3 months. At 1 year, 30 patients (85 %) were off of VKA treatment. In no instances, was device embolization or thrombus formation on surface device detected. More importantly, at 1-year follow-up no thromboembolic events had occurred.
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