Objectives: Recurrence of mitral regurgitation (MR) after mitral valve repair is not infrequent. We report the safety and feasibility of a novel adjustable annuloplasty device that permits downsizing the ring late after the initial surgery through a minimally invasive procedure under beating-heart conditions. Methods: In this multicentre, non-randomised, observational registry, 82 patients with moderate or severe MR (mean age 69 ± 10 years, mean EuroSCORE II 6.85 ± 6.35, 70% male, 51% ischaemic MR and 33% dilative cardiomyopathy) undergoing surgical mitral valve repair with this device were evaluated. Endpoints included in-hospital mortality, MR reduction and ring adjustment at follow-up. Results: In all patients, a significant reduction in MR was accomplished in the initial surgical procedure (99% of the patients with none or mild MR). In-hospital mortality was observed in 4 patients, 2 cardiac not device-related, and 2 non-cardiac deaths. Ring dehiscence occurred in 1 patient, stroke in 2 patients. In 12 patients (15%), an attempt to adjust the ring was performed due to recurrent MR (mean 9.5 months after surgery; 1 week to 19 months). In 3 of these attempts a technical failure occurred, in 1 patient, MR was reduced 2 levels, in 2 patients MR was reduced 1 level, and in 6 patients, MR did not change significantly. Conclusion: We conclude that implantation of this new adjustable annuloplasty ring is safe and effective. Late adjustment of this ring is feasible and may allow addressing recurrent MR. Additional experience and long-term follow-up are required to establish the clinical value of this technology.
Abstract Background The number of catheter ablation (CA) procedures has increased significantly over the last decade. 102,737 CA have been performed in Germany in 2021. Although CA of different types of arrhythmias is generally considered to be safe, serious complications, including in-hospital death, may occur. There is a paucity of real-world national healthcare data in Germany. Aim To investigate the overall in-hospital mortality in patients undergoing any type of CA procedure in Germany and to identify variables associated with in-hospital mortality. Methods According to the German law German hospitals are obliged to provide a dataset including case data, diagnosis based on the ICD-10-GM, operational and procedural codes to the Institute for hospital remuneration system (InEK) every year. The VARY project aims at analyzing and monitoring these data to report the real world scenario on patients undergoing CA in Germany. As of now, 22 German centers were contacted by the Institute for Myocardial Infarction Research (IHF). Their Data between 2019 and 2023 provided from seven of those centers were used for this analysis. Datasets from ten centers are pending. Five centers were not able to provide their data. The project is supported by the German Heart Foundation. Results A total 21,028 patients underwent inpatient CA. 49 patients (69.4% males) died in-hospital following a CA procedure resulting in an overall in-hospital mortality rate of 0.23%. A percutaneous epicardial ablation approach was used in 6.1% of the patients who died (Group A) compared to 0.3% in the surviving patients (Group B). Radiofrequency ablation was used in 83.7% vs. 72.6%, cryoablation in 10.2% vs 27.1%. Patients who died were older compared to those who survived (mean age: 66.7 ± 14.6 vs. 62.0 ± 14.4 years, p <0.01) and had more comorbidities such as diabetes (19/49 (38.8.%) vs. 2274/20,979 (10.8%), p <0,01), chronic obstructive pulmonary disease (5/49 (10.2%) vs. 555/20,979 (2.6%), p < 0,01) and heart failure (39/49 (79.6%) vs. 5116/20,979 (24.4%), p <0.01). There was no difference with regards to gender between the two groups. The most common arrhythmia in both groups was atrial fibrillation with 67.3% and 75.3% (p < 0.01). Cardiac arrest was observed in 44.9% of patients in group A compared to only 0.3% in group B. The median hospital stay was longer in group A (19.0 (IQR 8.0; 42.0) vs. 2.0 (IQR 1.0; 3.0), p < 0.01). 46/49 (93.9%) patients who died were treated on an intensive care unit for a median time of 13.5 days (IQR 3.8; 33.8) compared to 1272/20,979 (6.1%) (p < 0.01) in group B. A cardiac implantable electronic device implantation or revision was performed in 18.4% patients in group A (4 defibrillator implantations, 2 pacemaker implantations, 5 revisions) compared to 2.9% in group B (survivors). Conclusion Inpatient catheter ablation procedures in Germany are associated with a very low in-hospital mortality comparable to data reported from the US.
Objectives: The purpose was to evaluate the feasibility, effectiveness and safety of the use of laser (Edwards Optimize™ Surgical Ablation System, Edwards Lifescience) for linear endocardial ablation therapy for atrial fibrillation.
Abstract Background Hybrid Ablation for atrial fibrillation (AF) combines epicardial and endocardial ablation through a Heart Team approach to target durable, transmural isolation of the pulmonary veins (PV) and left atrial posterior wall (LAPW). While the primary efficacy endpoint at 12 months was met with a significant benefit increase for hybrid ablation, we now report the midterm durability of those results. Purpose To evaluate 24-months safety and effectiveness of Hybrid Ablation with left atrial appendage exclusion (LAAE) versus Catheter Ablation in patients with persistent AF/enlarged left atrium and longstanding persistent AF (LSPAF). Methods CEASE-AF is a prospective, multi-center, 2:1 randomized controlled trial. Eligible patients were 18-75 years of age, had symptomatic, drug-refractory persistent AF and enlarged left atrium (>4 cm) or LSPAF, and were undergoing a first ablation. Hybrid Ablation consisted of two stages: thoracoscopic epicardial radiofrequency (RF) ablation for PV and LAPW isolation and epicardial LAAE followed by endocardial ablation 91-180 days later. Catheter Ablation consisted of minimum PV isolation by endocardial RF ablation, and repeat ablation was allowed between 91-180 days. In both arms, additional lesions were permitted according to institutional practices. Effectiveness was freedom from AF/atrial flutter (AFL)/atrial tachycardia (AT) off anti-arrhythmic drugs (AAD) (except AADs not exceeding doses which previously failed) and was assessed through 48-h Holter monitoring reviewed by an independent core laboratory blinded to the study. Safety was major adverse events throughout the study, adjudicated by an independent Clinical Events Committee. Results There were 102 Hybrid Ablation and 52 Catheter Ablation patients; 26% were female, mean age was 60.7±7.9 years, mean LAD was 4.7±0.4 cm, and 19% had LSPAF with no differences between arms. The 12- and 24-month results are shown for comparison (Table). Through 24-months, effectiveness was 66.3% (63/95) in the Hybrid Arm and 33.3% (17/51) in the Catheter Arm (absolute difference 33.0% [95% CI 14.3%, 48.3%; p<0.001]). Major adverse event rates through 24-months were statistically similar at 10.8% (11/102) in the Hybrid Arm and 9.6% (5/52) in the Catheter Arm (p=1.0). Through 24-months, repeat ablations were performed in 7.4% (7/95) of the Hybrid Arm versus 37.3% (19/51) of the Catheter Arm (p<0.001), and cardioversions were performed in 14.7% (14/95) of the Hybrid Arm versus 29.4% (15/51) of the Catheter Arm (p=0.034) Conclusions: CEASE-AF demonstrated that superior effectiveness of Hybrid Ablation including LAAE versus Catheter Ablation was durable through 24-month follow-up, with 33% absolute improvement in freedom from AF/AFL/AT. Safety rates continued to be similar between arms. Three-year follow-up is ongoing.
