Clinical Course and Management of Patients with Emergency Surgery Treated with Direct Oral Anticoagulants or Vitamin K Antagonists-Results of the German Prospective RADOA-Registry.

(1) Background: The clinical management of anticoagulated patients treated with direct oral anticoagulants (DOAC) or Vitamin K antagonists (VKA) needing emergency surgery is challenging. (2) Methods: The prospective German RADOA registry investigated treatment strategies in DOAC- or VKA-treated patients needing emergency surgery within 24 h after admission. Effectiveness was analysed by clinical endpoints including major bleeding. Primary observation endpoint was in hospital mortality until 30 days after admission. (3) Results: A total of 78 patients were included (DOAC: 44; VKA: 34). Median age was 76 years. Overall, 43% of the DOAC patients and 79% of the VKA patients were treated with prothrombin complex concentrates (PCC) (p = 0.002). Out of the DOAC patients, 30% received no hemostatic treatment compared to 3% (1/34) of the VKA patients (p = 0.002), and 7% of the DOAC patients and 21% of the VKA patients developed major or clinically relevant non-major bleeding at the surgical site (p = 0.093). In-hospital mortality was 13% with no significant difference between the two treatment groups (DOAC: 11%, VKA: 15%; p > 0.20). (4) Conclusions: The 30-day in-hospital mortality rate was comparable between both patient groups. VKA patients required significantly more hemostatic agents than DOAC patients in the peri- and postoperative surgery period.

Cryoballoon Versus Laserballoon: Insights From the First Prospective Randomized Balloon Trial in Catheter Ablation of Atrial Fibrillation.

BACKGROUND: Pulmonary vein isolation (PVI) represents the cornerstone in atrial fibrillation ablation. Cryoballoon and laserballoon catheters have emerged as promising devices but lack randomized comparisons. Therefore, we sought to compare efficacy and safety comparing both balloons in patients with persistent and paroxysmal atrial fibrillation (AF). METHODS: Symptomatic AF patients (n=200) were prospectively randomized (1:1) to receive either cryoballoon or laserballoon PVI (cryoballoon: n=100: 50 paroxysmal atrial fibrillation + 50 persistent AF versus laserballoon: n=100: 50 paroxysmal atrial fibrillation + 50 persistent AF). All antiarrhythmic drugs were stopped after ablation. Follow-up included 3-day Holter-ECG recordings and office visits at 3, 6, and 12 months. Primary efficacy end point was defined as freedom from atrial tachyarrhythmia between 90 and 365 days after a single ablation. Secondary end points included procedural parameters and periprocedural complications. RESULTS: Patient baseline parameters were not different between both groups. In all (n=200) complete PVI was obtained and the entire follow-up accomplished. Balloon only PVI was obtained in 98% (cryoballoon) versus 95% (laserballoon) requiring focal touch-up in 2 and 5 patients, respectively. Procedure but not fluoroscopy time was significantly shorter in the cryoballoon group (50.9±21.0 versus 96.0±20.4 minutes; P<0.0001 and 7.4±4.4 versus 8.4±3.2 minutes, P=0.083). Overall, the primary end point of no atrial tachyarrhythmia recurrence was met in 79% (cryoballoon: 80.0% versus laserballoon: 78.0%, P=ns). No death, atrio-esophageal fistula, tamponade, or vascular laceration requiring surgery occurred. In the cryoballoon group, 8 transient but no persistent phrenic nerve palsy were noted compared with 2 persistent phrenic nerve palsy and one transient ischemic attack in the laserballoon group. CONCLUSIONS: Both balloon technologies represent highly effective and safe tools for PVI resulting in similar favorable rhythm outcome after 12 months. Use of the cryoballoon is associated with significantly shorter procedure but not fluoroscopy time.

Cryoballoon pulmonary vein isolation in treating atrial fibrillation using different freeze protocols: The "ICE-T 4 minutes vs 3 minutes" propensity-matched study (Frankfurt ICE-T 4 vs. 3).

BACKGROUND: Time-to-isolation (TTI) guided second-generation cryoballoon (CB2) ablation has been shown to be effective for pulmonary vein isolation (PVI). OBJECTIVE: The objective of this paper is to compare the safety and clinical outcome of CB2 PVI using the TTI guided 4 minutes vs 3 minutes freeze protocol. METHODS: This was a propensity-matched study based on an institutional database. Symptomatic atrial fibrillation (AF) patients who underwent CB2 PVI and systematic follow-up were consecutively included. RESULTS: A total of 573 patients were identified, of them 214 (107 matched-pairs) symptomatic AF (paroxysmal AF: 61%, persistent AF: 39%) patients (age: 67.7 ± 11.2 years) were analyzed. The baseline characteristics were comparable between the two groups. Procedural time was significantly longer in the 4 minutes group compared to 3 minutes group (67.2 ± 21.8 vs 55.9 ± 16.9 minutes, P < .0001). During a mean follow-up of 2 years, the 4 minutes group was associated with a significantly higher rate of freedom from arrhythmia recurrence compared with the 3 minutes group (66.4% vs 56.1%, P = .009), which was mainly driven by patients with persistent AF. The multivariate regression showed that the 4 minutes freeze was the independent predictor of freedom from arrhythmia recurrence. During the repeat procedure, the 4 minutes group was associated with a significantly higher rate of durable PVI. There was no difference regarding procedural adverse events between the two groups. CONCLUSION: As compared with the 3 minutes freeze, the TTI guided 4 minutes freeze is associated with a significantly higher rate of arrhythmia-free and durable PVI without compromising the safety profile, patients with persistent AF may benefit from the TTI guided 4 minutes freeze more pronouncedly.

Phrenic nerve injury in atrial fibrillation ablation using balloon catheters: Incidence, characteristics, and clinical recovery course.

AIMS: Systematic data on phrenic nerve palsy (PNP) associated with contemporary balloon ablation techniques (cryoballoon [CBA] vs laser balloon [LBA]) are sparse. We aimed to investigate the incidence, characteristics, and clinical recovery course in patients with PNP who underwent CBA or LBA. METHODS AND RESULTS: A total of 2433 consecutive patients who underwent balloon-based pulmonary vein isolation (CBA: n = 1720 and LBA: n = 713) were retrospectively identified. PNP was classified into (a) transient (recovery before discharge) or (b) persistent (within 6 months, 6-12 months, and >12 months) according to clinical recovery course. In general, PNP occurred significantly more often in CBA 71/1720 (4.2%) than LBA 11/713 (1.5%) (P = .003). The rate of transient PNP was significantly higher in CBA (3.0%, n = 45) than LBA (0.1%, n = 1, P = .004). The rate of persistent PNP did not significantly differ between two groups (CBA: 1.2% vs LBA: 1.4%, P = .89). The rate of persistent PNP which recovered within 6 months was similar (CBA: 17.4% vs LBA 18.2%, P = 1.000). However, the rates of persistent PNP which recovered within 6 to 12 months (CBA: 2.9% vs LBA 27.3%, P = .0171) and more than 12 months (CBA: 7.3% vs LBA 45.5%, P = .0034) were significantly higher in LBA. CONCLUSION: PNP occurred more often in CBA than LBA, however, the majority of PNP in CBA was transient whereas the majority of PNP in LBA was persistent. Either balloon technology is not superior in terms of long-term PNP.