One-year outcomes of wide antral cryoballoon ablation guided by high-density mapping vs. conventional cryoballoon ablation for atrial fibrillation: a propensity score-matched study.

Background: Pulmonary vein isolation with wide antral ablation leads to better clinical outcomes for the treatment of atrial fibrillation, but the isolation lesion is invisible in conventional cryoballoon ablation. In this study, we aim to investigate the efficacy of the wide pulmonary vein isolation technique that includes the intervenous carina region, guided by high-density mapping, compared with pulmonary vein isolation alone without the mapping system. Methods: We conducted a propensity score-matched comparison of 74 patients who underwent a wide cryoballoon ablation guided by high-density mapping (mapping group) and 74 controls who underwent conventional cryoballoon ablation in the same period (no-mapping group). The primary outcome was a clinical recurrence of documented atrial arrhythmias for >30 s during the 1-year follow-up. Results: Of 74 patients in the mapping group, residual local potential in the pulmonary vein antrum was found in 30 (40.5%) patients, and additional cryothermal applications were performed to achieve a wide pulmonary vein isolation. Compared with the no-mapping group, the use of the mapping system in the mapping group was associated with a longer fluoroscopic time (26.97 ± 8.07 min vs. 23.76 ± 8.36 min, P = 0.023) and greater fluoroscopic exposure [339 (IQR181-586) mGy vs. 224 (IQR133-409) mGy, P = 0.012]. However, no significant differences between the two groups were found in terms of procedural duration and left atrial dwell time (104.10 ± 18.76 min vs. 102.45 ± 21.01 min, P = 0.619; 83.52 ± 17.01 min vs. 79.59 ± 17.96 min, P = 0.177). The rate of 12-month freedom from clinical atrial arrhythmia recurrence was 85.1% in the mapping group and 70.3% in the no-mapping group (log-rank P = 0.029). Conclusion: Voltage and pulmonary vein potential mapping after cryoballoon pulmonary vein isolation can identify residual potential in the pulmonary vein antrum, and additional cryoablation guided by mapping leads to improved freedom from atrial arrhythmias compared with conventional pulmonary vein isolation without the mapping system. Clinical Trial Registration Number: ChiCTR2200064383.

Guidewire Ablation within the Coronary Venous System for Epicardial or Intramural Ventricular Arrhythmia: A Preclinical Study of Biophysical Characterization.

Background: Catheter ablation failure poses a clinical challenge for epicardial or intramural ventricular arrhythmia (VA); however, guidewire ablation within the coronary venous system (CVS) may be effective and safe for targeting VAs. Methods: The ex vivo phase included four steps. In step 1, the steam pop incidence rates during guidewire ablation at power settings of 5, 10, 15, 20, and 25 W were analyzed using 10 mm- and 20 mm-tip guidewires. In step 2, guidewire ablation was performed for application durations of 10, 20, 30, 40, 50, 60, and 90 s, and the lesion size was measured. In step 3, the effects of saline infusion (0, 1, 2, 3, and 4 mL/min) on lesion dimensions and steam pop formation were examined. In step 4, an orthogonal array was constructed to obtain the optimal guidewire ablation parameters. In the in vivo phase, guidewire ablation within the CVS was performed in three dogs, and the lesion features in 10 days after ablation were observed. Results: In step 1, the steam pop incidence rates at 5, 10, 15, 20, and 25 W were 0%, 0%, 12.5%, 62.5%, and 100% using the 10 mm-tip guidewires and 0%, 0%, 0%, 25%, and 75% using the 20 mm-tip guidewires, respectively. In step 2, we found that the lesion areas increased with an increase in the ablation duration (the maximum lesion diameters at 30, 60, and 90 s were 4.9 ± 0.4, 7.0 ± 0.8, and 9.2 ± 0.7 mm in the 10 mm group and 3.2 ± 0.5, 4.5 ± 0.4, and 5.3 ± 0.7 mm in the 20 mm-tip group, respectively). In step 3, we observed that saline infusion was negatively correlated with ablation lesions but had a lower risk of steam pop. The optimal parameters for the 20 mm-tip guidewire ablation were 15 W, 50 s, and 2 mL/min or 20 W, 70 s, and 2 mL/min. In the in vivo phase, effective ablation lesions with maximum and minimum diameters of 3.2 ± 0.3 and 2.8 ± 0.5 mm, respectively, were created by the guidewires during the 10-day observation period after ablation. Conclusion: This novel radiofrequency guidewire ablation technique can feasibly create effective lesions within the CVS, which may improve the efficacy of catheter ablation for challenging epicardial or intramural VA.

Effects of parameters on radiofrequency guidewire ablation: In vitro and in vivo experiments.

BACKGROUND: A novel ablation technique with guidewire has emerged as a promising approach for mapping and ablation of arrhythmias originating from left ventricular summit. However, its biophysical characteristics have not been fully clarified. METHODS AND RESULTS: In the in vitro experiment, guidewire ablation (GA) was performed in vessel models of 1.17 and 2.24 mm to determine the maximum safety power. Then with the maximum safety power, the predictive value of generator impedance (GI) drop on lesion radius was explored. In the in vivo experiment, the feasibility of the maximum safety power and lesion formation was verified in the living swine. It was found that in both groups, the incidence of steam pops increased along with the raise of ablation power, and the maximum safety power was 10 W for the 1.17-mm group and 15 W for the 2.24-mm group. There was a strong linear correlation between GI drop and maximum lesion radius (in 1.17 mm-10-W group: r = .961; in 2.24 mm-15-W group: r = .918). In the in vivo experiment, besides ventricular fibrillation happened once, no other complications were observed, and lesions were found at both 48-h and 8-week groups. CONCLUSIONS: The safety power of GA should be adjusted according to the diameter of the vessel. Besides, the GI drop can predict the lesion radius during GA.

The impacts of different embolization techniques on splenic artery embolization for blunt splenic injury: a systematic review and meta-analysis.

BACKGROUND: Splenic artery embolization (SAE) has been an effective adjunct to the Non-operative management (NOM) for blunt splenic injury (BSI). However, the optimal embolization techniques are still inconclusive. To further understand the roles of different embolization locations and embolic materials in SAE, we conducted this system review and meta-analyses. METHODS: Clinical studies related to SAE for adult patients were researched in electronic databases, included PubMed, Embase, ScienceDirect and Google Scholar Search (between October 1991 and March 2013), and relevant information was extracted. To eliminate the heterogeneity, a sensitivity analysis was conducted on two reduced study sets. Then, the pooled outcomes were compared and the quality assessments were performed using Newcastle-Ottawa Scale (NOS). The SAE success rate, incidences of life-threatening complications of different embolization techniques were compared by χ2 test in 1st study set. Associations between different embolization techniques and clinical outcomes were evaluated by fixed-effects model in 2nd study set. RESULTS: Twenty-three studies were included in 1st study set. And then, 13 of them were excluded, because lack of the necessary details of SAE. The remaining 10 studies comprised 2nd study set, and quality assessments were performed using NOS. In 1st set, the primary success rate is 90.1% and the incidence of life-threatening complications is 20.4%, though the cases which required surgical intervention are very few (6.4%). For different embolization locations, there was no obvious association between primary success rate and embolization location in both 1st and 2nd study sets (P > 0.05). But in 2nd study set, it indicated that proximal embolization reduced severe complications and complications needed surgical management. As for the embolic materials, the success rate between coil and gelfoam is not significant. However, coil is associated with a lower risk of life-threatening complications, as well as less complications requiring surgical management. CONCLUSIONS: Different embolization techniques affect the clinical outcomes of SAE. The proximal embolization is the best option due to the less life-threatening complications. For commonly embolic material, coil is superior to gelfoam for fewer severe complications and less further surgery management.

Thrombin-loaded alginate-calcium microspheres: A novel hemostatic embolic material for transcatheter arterial embolization.

Transcatheter arterial embolization (TAE) is the best non-laparotomy choice for solid visceral organs rupture and bleeding nowadays. In our previous study, a new biodegradable macromolecule material thrombin-loaded alginate-calcium microsphere (TACM) was prepared and its characteristics were investigated preliminarily. In this study, we further investigated the biocompatibility of TACMs, as well as physical characteristic, application method and effect of TACMs with thrombus (embolic agent). The in vivo results attested that TACMs were non-irritating and non-genotoxic with desired biocompatibility, although brought about a slight and temporary inflammation. Application research showed that the function of thrombin was inhibited by common contrast agents, and it was impracticable to add contrast agents in TACMs with thrombus for tracing under X-rays in TAE. Then, a novel delivery method was developed. In addition, stress resistance test indicated that the TACMs with thrombus was significantly stronger than single autologous thrombus, the optimized ratio of TACMs to whole blood was 2:3 for forming mixed thrombus. Finally, large animal experiment revealed that the novel embolic agent - TACMs mixed thrombus was effective and safe in treating hemorrhage of solid abdominal viscera by TAE.

Biocompatibility and Effectiveness Evaluation of a New Hemostatic Embolization Agent: Thrombin Loaded Alginate Calcium Microsphere.

Background. Until now, there has been no ideal embolization agent for hemorrhage in interventional treatment. In this study, the thrombin was encapsulated in alginate calcium microsphere using electrostatic droplet technique to produce new embolization agent: thrombin loaded alginate calcium microspheres (TACMs). Objectives. The present work was to evaluate the biocompatibility and hemostatic efficiency of TACMs. Methods. Cell cytotoxicity, hemolysis, and superselective embolization of dog liver arteries were performed to investigate the biocompatibility of TACMs. To clarify the embolic effect of TACMs mixed thrombus in vivo, hepatic artery injury animal model of 6 beagles was established and transcatheter artery embolization for bleeding was performed. Results. Coculture with VECs revealed the noncytotoxicity of TACMs, and the hemolysis experiment was negligible. Moreover, the histological study of TACMs in liver blood vessel showed signs of a slight inflammatory reaction. The results of transcatheter application of TACMs mixed thrombus for bleeding showed that the blood flow was shut down completely after the TACMs mixed thrombus was delivered and the postprocedural survival rate of animal models at 12 weeks was 100%. Conclusions. With their good biocompatibility and superior hemostatic efficiency, TACMs might be a promising new hemostatic agent with a wide range of potential applications.

A mobile minimally invasive interventional shelter: a new answer to on-spot emergency treatment of large arterial injuries?

BACKGROUND: Severely destructive disasters can often lead to heavy casualties. Large arterial injury in disasters, particularly, often results in high mortality and morbidity. Although minimally invasive intervention has achieved positive effects in diagnosing and treating vascular injuries, it is still unavailable at the disaster area of any country due to lack of on-spot catheterization labs. This study aimed to test the feasibility of adopting interventional techniques to treat haemorrhage of large arterial injuries in remote and austere wild environments after severely destructive disasters, by using a new mobile intervention suite we developed--the mobile minimally invasive interventional shelter (MIS). METHODS: Large animal models of aortic and femoral arterial injuries were established using a newly developed medium vehicle-mounted digital subtraction angiography (DSA) machine in MIS. The endovascular stent-graft exclusion and balloon occlusion combined with surgical hemostasis were performed respectively following the protocols for rapid interventional therapy. The treatment capacity of the shelter was evaluated based on its stability, surgery duration and the clinical results. RESULTS AND DISCUSSION: The stability of the medical devices in MIS directly relates to the efficiency and success rate of interventional treatment. The newly developed vehicle-mounted DSA machine showed good imaging performance and the operation of all equipments and devices in MIS were stable in interventional procedures. All the interventional treatments for large arterial injuries were performed smoothly. The average time for treating abdominal aortic injury and femoral arterial injury was 23 ± 11 and 55 ± 17 min, respectively. And the operation success rate reached 100 %. CONCLUSION: It is feasible to perform interventional operations to control haemorrhage of large arterial injuries in MIS outside hospital. The MIS has a great potential to save patients from dying of hemorrhagic shock due to lack of effective treatment devices and approaches in remote and austere wild environments, such as in disaster areas.

Alginate-calcium microsphere loaded with thrombin: a new composite biomaterial for hemostatic embolization.

To date, transcatheter arterial embolization (TAE) has become a standard treatment to control intracavitary bleeding as an alternative to surgery. Due to excellent biocompatibility and no residual in vivo, biodegradable materials are preferred in TAE. However, gelfoam is the only commercially available biodegradable embolic material used to treat blunt trauma of solid abdominal viscera until now, and controversial on its stability and reliability never stopped in the past five decades. In this study, a new biodegradable macromolecule material (thrombin-loaded alginate-calcium microspheres, TACMs) was prepared using electrostatic droplet techniques and a special method was developed for hemostatic embolization. Thrombin was successfully loaded into microspheres with high encapsulation efficiency and drug loading capacity. A burst release of TACMs was observed at early stage and sustained release later on, with the activity of thrombin preserved well. The strength of TACMs mixed thrombus, which was used as embolic agent, increased in a dose-dependent manner after TACMs were added. In addition, the TACMs were verified to be of no cytotoxicity and systemic toxicity, and biodegradable in vivo. Finally, the results of preliminary applications revealed that the TACMs could serve as an effective and promising embolic material for blunt trauma and hemorrhage of solid abdominal viscera.

Emergency treatment of splenic injury in a novel mobile minimally invasive interventional shelter following disaster: a feasibility study.

BACKGROUND: There has been an increase in natural disasters in recent years, which leads to a great number of injuries and deaths. It still remains an unsolved problem to treat patients with vascular injury of solid organs effectively following natural disasters, but on-spot emergency interventional transcatheter arterial embolization (TAE) has been highly recommended to cure serious vascular injury of solid organs nowadays. Spleen is the most vulnerable abdominal organ, severe arterial hemorrhage of which can cause death if untreated timely. In this research, we aimed to study the possibility of performing emergency surgical intervention in mobile minimally invasive interventional shelter for splenic injury in the case of natural disasters. METHODS: First, the mobile minimally invasive interventional shelter was unfolded in the field, and then disinfection and preoperative preparation were performed immediately. Eight large animal models of splenic injury were created, and angiograms were performed using a digital subtraction angiography machine in the mobile minimally invasive interventional shelter, and then the hemostatic embolizations of injured splenic artery were performed following the established convention of rapid intervention therapy. The operating time was recorded, and the survival condition and postoperative complications were observed for two weeks. RESULTS AND DISCUSSION: The average time of unfolding the shelter, and performing disinfection and preoperative preparation was 33 ± 7 min. The number of colonies in the sterilized shelter body was 86 ± 13 cfu/m(3). The average TAE time was 31 ± 7 min. All the hemostatic embolizations of splenic injury were performed successfully in the mobile minimally invasive interventional shelter during the operation. A pseudoaneurysm was found in an animal model using angiography two weeks after the operation. The primary clinical success rate of embolization was 87.5%. The two-week survival rate in all animal models of splenic injury was 100%. CONCLUSIONS: Our findings in the current study demonstrate that the mobile minimally invasive interventional shelter can be adapted to the field perfectly and complete emergency surgical intervention for splenic injury efficiently and safely. Therefore, on-spot emergency interventional TAE for vascular injury of solid organs (e.g. spleen) in mobile minimally invasive interventional shelter is available and effective.