Comparison of the first and second cryoballoon: high-volume single-center safety and efficacy analysis.

BACKGROUND: Cryoballoon (CB) ablation results in >70% freedom from atrial fibrillation at 1 year. Single-center data of the first (CBG1) and second (CBG2) cryoballoon, recently introduced, were analyzed to compare safety and efficacy. METHODS AND RESULTS: From March 2011 to December 2012, CB ablation with spiral mapping was performed consecutively in 484 patients with symptomatic atrial fibrillation. CBG1 was used in 364 of 484 (75%) and CBG2 in 120 of 484 (25%) patients. Periprocedural data were analyzed. Acute pulmonary vein (PV) isolation with CB only was achieved in 99.86% and 100% of veins with CBG1 and CBG2, respectively (P=0.43). Number of applications until PV isolation decreased significantly with CBG2 (1.45±0.81 versus 1.28±0.64; P=0.001). Procedural, left atrial, and fluoroscopy time were reduced by -5%, -11%, and -15% (P<0.05), respectively. Two balloons were used less frequently. Time to isolation decreased significantly with 23-mm (48 versus 33 seconds; P<0.0001) and 28-mm CBG2 (76 versus 52 seconds; P<0.0001). Early PV reconduction rarely occurred with CBG2 (2.6% versus 0.42%; P=0.0023). In-hospital atrial fibrillation recurrence rates were similar. Balloon temperatures were significantly warmer with 23-mm CBG2 and a trend for colder balloon temperature with 28-mm CBG2 were observed compared with their predecessors. Comparable low rates of phrenic nerve palsy were recorded (1.1% versus 1.7%; P=0.64). Esophageal temperatures were similar. Major complication rates were low (3.3% versus 3.33%; P=1.0). CONCLUSIONS: CBG2 attains high rates of acute PV isolation within a significant faster and less complex procedure. Time to isolation is shorter, and PV isolation is achieved with fewer applications using CBG2. These enhancements were not at the cost of complications. Long-term success rates remain to be demonstrated.

Aortic valve calcium score as a predictor for outcome after TAVI using the CoreValve revalving system.

BACKGROUND: TAVI is a novel treatment option for patients at too high risk for surgery. Risk scores for surgical valve replacement failed to accurately predict outcomes after TAVI and alternative risk parameters are lacking so far. OBJECTIVE: We evaluated the CT-derived aortic valve calcification score as a predictor for outcome during and after TAVI. METHODS: Transfemoral TAVI using the CoreValve device was performed in 68 patients, in whom the aortic valve calcium score was determined from preprocedural 64-sclice ECG gated CT-scans. RESULTS: 30-day MACE rate (death, stroke, MI) was 10.3%, 1-year mortality was 11.8%. Using linear regression analysis the aortic valve calcium score was the only significant predictor for 30-day MACE and for 1-year mortality and was also associated with the incidence and severity of post procedural aortic regurgitation (r=0.33, p<0.05). Patients withvalve calcium scores >750 had a significant lower 1-year survival rate compared to patients with scores <750 (58% vs. 98%, p<0.05). The aortic valve calcium score is also inversely associated with the absolute improvement of NYHA-class after TAVI (regression coefficient=-0.43, p<0.02). CONCLUSION: The degree of aortic valve calcification is associated with post procedural aortic regurgitation, procedural complications, 1-year mortality and with the degree of functional improvement of patients who underwent TAVI using the CoreValve device. Due to the fact that the aortic valve calcium score can be determined from CT-datasets that are used for preprocedural planning, this parameter may be incorporated in the general work up and may be used for risk stratification and patient selection.

Targeted endothelial delivery of nanosized catalase immunoconjugates protects lung grafts donated after cardiac death.

BACKGROUND: Donor organ shortage represents a major problem in lung transplantation. Donation after cardiac death could help to expand the pool of organs, but the additional period of warm ischemia after cardiac arrest aggravates primary graft dysfunction. The pulmonary endothelium of the graft constitutes an important source and target of reactive oxygen species generated during ischemia and reperfusion. Targeted protection of graft pulmonary endothelial cells by the antioxidant enzyme catalase, conjugated with a platelet/endothelial cell adhesion molecule-1 (PECAM-1) antibody to nanosized particles (anti-PECAM/catalase conjugates), might improve outcome in lung transplantation using donors after cardiac death and prolonged hypothermic preservation. METHODS: Left lung transplantation was performed in 18 pigs. Before cardiac arrest, donors received anti-PECAM/catalase, unconjugated component mixture or vehicle solution. After 90-min warm and 18-hr hypothermic ischemia, lungs were transplanted, and function was assessed during 6 hr after reperfusion. Samples of bronchoalveolar lavage fluid and lung tissue were taken thereafter. Six sham-operated animals served as controls. RESULTS: During 6-hr reperfusion, anti-PECAM/catalase significantly ameliorated graft function, evidenced by major improvements of gas exchange and reduced intrapulmonary shunt fraction. Furthermore, lipid peroxidation, alveolar leakage, and edema formation were reduced in protected grafts. Similarly moderate lung pathology was seen after transplantation. CONCLUSIONS: Augmentation of the antioxidant capacity of graft pulmonary endothelial cells with anti-PECAM/catalase nanoparticles represents a straightforward approach to enable a safe transplantation of prolonged preserved donation after cardiac death lungs. Anti-PECAM/catalase protection alleviated oxidative stress and allowed immediate reconstitution of normal gas exchange and pulmonary microcirculation, a prerequisite for improved graft and patient outcome.