Impact of Universal Use of the McGrath Videolaryngoscope as a Device for All Intubations in the Cardiac Operating Room. A Prospective Before-After VIDEOLAR-CAR Study.

OBJECTIVE: Tracheal intubation in cardiac surgery patients has a higher incidence of difficult laryngoscopic views compared with patients undergoing other types of surgery. The authors hypothesized that using the McGrath Mac videolaryngoscope as the first intubation option for cardiac surgery patients improves the percentage of patients with "easy intubation" compared with using a direct Macintosh laryngoscope. DESIGN: A prospective, observational, before-after study. SETTING: At a tertiary-care hospital. PARTICIPANTS: One thousand one hundred nine patients undergoing cardiac surgery. INTERVENTION: Consecutive patients undergoing cardiac surgery were intubated using, as the first option, a Macintosh laryngoscope (preinterventional phase) or a McGrath Mac videolaryngoscope (interventional phase). MEASUREMENTS AND MAIN RESULTS: The main objective was to assess whether the use of the McGrath videolaryngoscope, as the first intubation option, improves the percentage of patients with "easy intubation," defined as successful intubation on the first attempt, modified Cormack-Lehane grades of I or IIa, and the absence of the need for adjuvant airway devices. A total of 1,109 patients were included, 801 in the noninterventional phase and 308 in the interventional phase. The incidence of "easy intubation" was 93% in the interventional phase versus 78% in the noninterventional phase (p < 0.001). First-success-rate intubation was higher in the interventional phase (304/308; 98.7%) compared with the noninterventional phase (754/801, 94.1%; p = 0.005). Intubation in the interventional phase showed decreases in the incidence of difficult laryngoscopy (12/308 [3.9%] v 157/801 [19.6%]; p < 0.001), as well as moderate or difficult intubation (5/308 [1.6%] v 57/801 [7.1%]; p < 0.001). CONCLUSIONS: The use of the McGrath videolaryngoscope as the first intubation option for tracheal intubation in cardiac surgery improves the percentage of patients with "easy" intubation," increasing glottic view and first-success-rate intubation and decreasing the incidence of moderate or difficult intubation.

A systematic review of the quality of cardiovascular surgery studies that extracted data from the MAUDE database.

OBJECTIVE: To investigate opportunities and limitations of using the Manufacturer and User Facility Device Experience (MAUDE) database for cardiovascular surgery research, we analyzed the quality of studies having ever used MAUDE, in the field of cardiovascular surgery. METHODS: We systematically searched the Cochrane Library, PubMed, EMBASE, and Google Scholar for randomized and nonrandomized studies, from inception to July 2019. Two authors evaluated the quality of the retrieved observational studies, according to the National Institutes of Health quality assessment tool for either case series or cross-sectional studies. These tools quantify the quality of case series and cohorts/cross-sectional studies, respectively, with nine and 14 queries. RESULTS: Fifty-eight studies were included in the final qualitative review. Of 58 identified studies, 32 were case series, 8 were abstracts of case series, and 13 were reviews or case discussion with an included series from MAUDE. Also, five articles were cross-sectional studies. Of the 32 formal case series, 26 (81%) were found to have poor quality. The most common reasons for a poor quality designation included a lack of consecutive participants, undetermined comparability of participants, and undetermined follow-up adequacy. Only one out of five cross-sectional studies had fair quality; four others were evaluated as poor quality studies. CONCLUSIONS: Cardiovascular surgery studies using the MAUDE database, whether case series or cross-sectional design, are mostly of poor quality. Their low quality is partly caused by poor study design, but mainly by intrinsic limitations to the MAUDE database: cases recruited are not consecutive; patient characteristics are not detailed enough to allow a meaningful comparison of patient characteristics between different patient entries; outcome measures are unclear; there is a limited follow-up; and time-to-event data are lacking. We conclude that the quality of cardiovascular surgery publications that rely on data from MAUDE could be improved if investigators were to extract all relevant data points from MAUDE entries, then apply standard quality assessment tools in compiling and reporting the data. MAUDE might be improved if it used medical case report standards during the process of reporting and indexing adverse events. To calculate the incidence rate of any adverse event, all event-free cases, as well as all adverse events in patients using a device, are required. Neither of these two variables is available in the MAUDE at the time of writing.

Transseptal access through atrial flow regulator device during ventricular tachycardia ablation.

Novel interventional therapies for heart failure patients are emerging like atrial flow regulator (AFR). Our case showed that endocardial ventricular tachycardia (VT) ablation could be performed safely by passing through the AFR device lumen without additional transseptal puncture in these patients.

Device related thrombus after left atrial appendage closure: State of the art.

Atrial fibrillation (AF), the most common arrhythmia, is a major cause of stroke and systemic embolism. Patients with AF are at higher risk of stroke with the left atrial appendage (LAA) being the most common site for thrombus formation. Although oral anticoagulation (OAC) remains the standard of care for stroke prevention in AF patients, there are still several limitations, including increased risk of bleeding and noncompliance. LAA closure (LAAC) has been found to be non-inferior to OAC in preventing all-cause strokes and systemic embolisms in randomized clinical trials, and is increasingly performed for stroke prevention in patients with nonvalvular AF (NVAF). However, device-related thrombus (DRT) after LAAC and a potentially increased risk of stroke related to DRT were observed in several registered studies, and attract wide concern. This review provides a comprehensive update on the incidence, mechanism, risk factors, prevention, diagnosis, and treatment of DRT after LAAC in patients with NVAF.

Effects of tubing degradation and pump position on extracorporeal circulation performance.

Extracorporeal circulation (ECC) is an integral part of cardiac surgery. Yet, the contact with artificial surfaces, mechanical stress, shear, and suction forces within the ECC pose a pronounced risk for damaging the corpuscular components of the blood. These suction forces may be reduced by a repositioning of the roller pumps employed below the reservoir. Furthermore, the repeated compression of the involved silicone tubing is likely to cause degradation. We present our observations regarding changes in the ECC performance following this degradation process. In vitro experiments were performed in a standard as well as a simplified ECC setup and included measurements of pressure, effective flow, and tubing restoring force over a time frame of 12 hours with two different pump positions utilizing transit time flow measurement. Suction forces within the tubing could be significantly reduced by shifting the pump position below the reservoir. Regardless of the setup, the tubing showed significant loss of restoring force as well as effective flow over time. A shift of the pump position within the ECC setup can be recommended to prevent blood damaging negative pressures. Further research is necessary to evaluate the exact cause of the reduction of restoring force overtime as well as its risks for the patients. Finally, our results underline the importance of transit time flow measurements to collect reliable flow data.

Nitric oxide added to the sweep gas of the oxygenator during cardiopulmonary bypass in infants: A pilot randomized controlled trial.

Our objective was to assess the effect of nitric oxide added to the sweep gas of the oxygenator during cardiopulmonary bypass (CPB) in infants on platelet count, platelet function, clinical outcomes, and safety. A randomized, double-blinded, placebo-controlled clinical trial in infants less than a year of age undergoing cardiac surgery requiring CPB was undertaken. Nitric oxide at a dose of 20 ppm was added to the sweep gas in the treatment group. Blood was collected at baseline and prior to separation from CPB to measure platelet count and function as determined by responsiveness to specific agonists. Clinical outcomes were observed through hospital discharge. Methemoglobin levels were measured preoperatively, at the conclusion of CPB, and upon admission to the ICU. Forty patients consented and were randomized in the trial. Eighteen patients were randomized to the treatment group and 22 were included in the placebo group. The groups were similar in terms of age, weight, gender, and surgical complexity. No significant differences were found in measures of platelet count, platelet response to agonist, or clinical outcomes. Patients in the treatment group had higher methemoglobin levels after receiving nitric oxide, but no levels approached toxicity (maximum 2.4%). Nitric oxide added to the sweep gas of the oxygenator during CPB in infants did not have an appreciable effect on the preservation of platelet count, platelet responsiveness to agonist, or clinical outcomes. Methemoglobin levels were increased after receiving nitric oxide but were far below a toxic level of 15%.

The use of Lean Methodology to reduce personal protective equipment wastage in children undergoing congenital cardiac surgery, during the COVID-19 pandemic.

BACKGROUND: The COVID-19 pandemic has compounded many existing healthcare delivery challenges including long waiting lists and cost containment. New challenges have arisen, such as demand on supply of personal protective equipment (PPE) and the implications of social distancing on staff, patients, and their families. Despite the pandemic, the need to deliver safe, urgent congenital cardiac surgery has remained. OBJECTIVE: To demonstrate how Lean methodology can improve PPE supply chain demand and reduce staff exposure to children with unknown SARS-CoV-2 status undergoing congenital cardiac surgery, during the COVID-19 pandemic. METHODS: We implemented the define, measure, analyze, improve, and control method (DMAIC) and Value Stream Maps to eliminate waste steps during testing for SARS-CoV-2 for children undergoing congenital cardiac surgery. RESULTS: Following a 3-week period of implementation of this new value stream map, we reduced PPE set usage from 13 to 1 per patient, resulting in an annual saving of over €36,000 and reducing single-use plastic waste by nearly 70 000 pieces per annum. We reduced numbers of staff exposed to patients with an unknown SARS-CoV-2 status from 13 to 1. CONCLUSION: The use of Lean methodology can reduce waste of PPE and plastic, resulting in cost savings, while reducing staff exposure when testing patients with congenital cardiac disease for SARS-CoV-2. By preventing admission of SARS-CoV-2-positive patients, we can reduce use of isolation beds and prevent cancellation of surgery, improving patient flow and departmental efficiency. Other departments in our institution are implementing similar admission pathways to allow surgical services to restart during the ongoing pandemic.

Use of a cutting stapler to excise a left atrial appendage in minimally invasive cardiac surgery.

PURPOSE: A cutting stapler is a well-established instrument in many surgical fields. However, its efficacy and safety have not been proven yet in resecting a left atrial appendage (LAA) in minimally invasive cardiac surgery (MICS). METHODS: A cutting stapler was used to resect the LAA in 98 consecutive patients who underwent MICS. Of these, 26 patients underwent aortic valve replacement, 72 mitral valve repair/replacement, 25 tricuspid annuloplasty, 7 closure of atrial septal defect, and 26 the Maze procedure (contains overlapping). The ascending aorta was elevated using a retractor, and a 12-mm shaft motor-driven cutting stapler was inserted through the transverse sinus. As a control group, 150 patients who underwent suture resection/closure of the LAA either from inside or outside were compared. RESULTS: There was one mortality in each group. They were not related to the LAA resection/closure. In the suture group, the LAA suture was taken down in one patient because of a suspected obstruction of the circumflex artery, and two patients had re-exploration for bleeding from the LAA. In the stapler group, there was no complication related with the LAA. The rate of complication did not reach a statistical difference. CONCLUSION: A cutting stapler is considered to be a useful instrument to resect the LAA in MICS.

Long-Term Safety and Efficacy of Percutaneous Left Atrial Appendage Closure with the LAmbre Device.

BACKGROUND: Left atrial appendage closure (LAAC) using the LAmbre device has been associated with prevention of stroke in patients with nonvalvular atrial fibrillation (AF). Here, we interrogated the long-term safety and efficacy of using the LAmbre device in percutaneous LAAC. METHODS: We analyzed 56 records of patients with nonvalvular AF undergoing LAAC procedures with the LAmbre device. We collected and analyzed the data to define the safety and efficacy of the LAmbre device implantation. RESULT: The LAAC was successfully occluded in the 56 patients. Our data showed no serious residual leak or pericardial effusion occurred during the perioperative period. At a mean follow-up of 37.8 ± 23.5 months, there were 7.1%, 3.6%, and 3.6% rates of death, stroke, and device-related thrombus, respectively. There were no cases of severe residual leak or systemic embolism. CONCLUSION: Taken together, we demonstrate that execution of LAAC with the LAmbre device has high procedural success and prevents AF-related stroke. However, further large-scale trials might be required to confirm our findings.

Feasibility of Left Atrial Appendage Closure in Atrial Fibrillation Patients with a History of Intracranial Bleeding: A Systematic Review of Observational Studies.

BACKGROUND: Left atrial appendage occlusion (LAAO) is performed in patients with nonvalvular atrial fibrillation to reduce the risk of ischemic stroke. The patients with a history of intracranial hemorrhage were excluded from the pioneer randomized controlled trials. The purpose of this systemic review was to evaluate the data from observational studies reporting the efficacy and safety of LAAO in patients with a history of intracranial hemorrhage. METHODS: Ovid MEDLINE, Embase, Cochrane Central Register of Controlled Trials, Web of Science Core Collection, Scopus, Global Index Medicus, and ClinicalTrials.gov data sources were utilized for data collection. RESULTS: A total of 12 studies met the inclusion criteria that included seven retrospective observational and five prospective observational studies. A total of seven hundred and twenty-seven patients with a history of intracranial hemorrhage underwent percutaneous left atrial appendage occlusion. There were 11 events of recurrent intracranial hemorrhage, 12 ischemic strokes, 4 transient ischemic attacks, and 26 all-cause deaths. The duration of follow-up varied from 3 months to 3.6 years in the included studies. CONCLUSION: Left atrial appendage occlusion can potentially be an effective and relatively safe treatment option to reduce the risk of ischemic stroke in selected patients with nonvalvular atrial fibrillation patients and history of intracranial hemorrhage. Future prospective randomized trials are needed to validate this approach.

Transcatheter Closure of Perimembranous Ventricular Septal Defect with Aneurysm: Radiologic Characteristic and Interventional Strategy.

OBJECTIVES: We aimed to explore the radiologic characteristics and interventional strategies for perimembranous ventricular septal defect (pmVSD) with aneurysm. METHODS: 257 patients who underwent transcatheter closure of pmVSD with aneurysm were included in our study. We retrospectively reviewed the left ventricular opening of the aneurysm (a), diameter of the midsegment of the aneurysm (b), and diameter of the right ventricular opening of the aneurysm (c). If there were multiple defects within the aneurysm, the largest defect was denoted as c 1 and so forth. We developed a novel VSD classification method in which pmVSD with aneurysm was classified into three types (A, B, and C). When a >b ≥ c, it was classified as type A, when b > a ≥ c, it was type B, and when c > a ≥ b, it was type C; c/c 1 described the relationship among defects. RESULTS: All of the 257 cases of pmVSD with aneurysm were defined using left ventriculography: type A, 60, type B, 58, and type C, 139. Transcatheter closure was attempted in 244 patients and succeeded in 227 cases (success rate was 93.0%; 227/244). Forty symmetric VSD occluders and 13 asymmetric VSD occluders were used for type A aneurysm occlusion; 31 symmetric VSD occluders, 19 asymmetric VSD occluders, and one Amplatzer duct occluder II (ADOII) were used for type B; 59 VSD symmetric occluders, 59 asymmetric VSD occluders, three eccentric VSD occluders, and two ADOII were used for type C. Within 24 hours after procedure, 2.2% patients had postprocedural residual shunt, and 2.2% experienced malignant arrhythmia (including type II second-degree AVB, cAVB, and CLBBB). Two hundred and twelve patients completed follow-up (93%, 212/227). No new severe complications were reported during follow-up, except in one patient who underwent surgery (removal of the device, VSD repair, and tricuspid valvuloplasty) due to severe postprocedural tricuspid regurgitation. CONCLUSIONS: It is safe and effective to apply this method for the classification of pmVSD with aneurysm and its interventional strategy.

Partnership Between Japan and the United States for Early Development of Pediatric Medical Devices　- Harmonization By Doing for Children.

BACKGROUND: The Harmonization By Doing (HBD) program was established in 2003 as a partnership among stakeholders of academia, industry and regulatory agencies in Japan and the United States, with a primary focus on streamlining processes of global medical device development for cardiovascular medical devices. While HBD has traditionally focused on development of devices intended to treat conditions prevalent in adults, in 2016, HBD established the "HBD-for-Children" program, which focuses on the development of pediatric devices as the development of medical devices for pediatric use lags behind that of medical devices for adults in both countries.Methods and Results:Activities of the program have included: (1) conducting a survey with industry to better understand the challenges that constrain the development of pediatric medical devices; (2) categorizing pediatric medical devices into five categories based on global availability and exploring concrete solutions for the early application and regulatory approval in both geographies; and (3) facilitating global clinical trials of pediatric medical devices in both countries. CONCLUSIONS: The establishment of the HBD-for-Children program is significant because it represents a global initiative for the introduction of pediatric medical devices for patients in a timely manner. Through the program, academia, industry and regulatory agencies can work together to facilitate innovative pediatric device development from a multi-stakeholder perspective. This activity could also encourage industry partners to pursue the development of pediatric medical devices.

Fully automated postoperative ventilation in cardiac surgery patients: a randomised clinical trial.

BACKGROUND: Ensuring that lung-protective ventilation is achieved at scale is challenging in perioperative practice. Fully automated ventilation may be more effective in delivering lung-protective ventilation. Here, we compared automated lung-protective ventilation with conventional ventilation after elective cardiac surgery in haemodynamically stable patients. METHODS: In this single-centre investigator-led study, patients were randomly assigned at the end of cardiac surgery to receive either automated (adaptive support ventilation) or conventional ventilation. The primary endpoint was the proportion of postoperative ventilation time characterised by exposure to predefined optimal, acceptable, and critical (injurious) ventilatory parameters in the first three postoperative hours. Secondary outcomes included severe hypoxaemia (Spo2 <85%) and resumption of spontaneous breathing. Data are presented as mean (95% confidence intervals [CIs]). RESULTS: We randomised 220 patients (30.4% females; age: 62-76 yr). Subjects randomised to automated ventilation (n=109) spent a 29.7% (95% CI: 22.1-37.4) higher mean proportion of postoperative ventilation time receiving optimal postoperative ventilation after surgery (P<0.001) compared with subjects receiving conventional postoperative ventilation (n=111). Automated ventilation also reduced the proportion of postoperative ventilation time that subjects were exposed to injurious ventilatory settings by 2.5% (95% CI: 1-4; P=0.003). Severe hypoxaemia was less likely in subjects randomised to automated ventilation (risk ratio: 0.26 [0.22-0.31]; P<0.01). Subjects resumed spontaneous breathing more rapidly when randomised to automated ventilation (hazard ratio: 1.38 [1.05-1.83]; P=0.03). CONCLUSIONS: Fully automated ventilation in haemodynamically stable patients after cardiac surgery optimised lung-protective ventilation during postoperative ventilation, with fewer episodes of severe hypoxaemia and an accelerated resumption of spontaneous breathing. CLINICAL TRIAL REGISTRATION: NCT03180203.

The force stability of tissue contact and lesion size index during radiofrequency ablation: An ex-vivo study.

INTRODUCTION: Radiofrequency (RF) ablation is a commonly used tool in the invasive electrophysiology laboratory to treat a variety of rhythm disorders. Reliable creation of transmural ablation lesions is crucial for long-term success. Lesion size index (LSI) is a multiparametric index that incorporates time, power, contact force (CF), and impedance data recorded during RF ablation in a weighted formula and has been shown to predict the extent of myocardial tissue lesions. Whether the force stability of contact influences lesion size in LSI-guided ablations is unknown. OBJECTIVES: The aim of this study was to analyze the influence of the force stability of contact on lesion size during LSI-guided ablations in an ex-vivo model. METHODS AND RESULTS: A total of 267 RF lesions (n = 6 hearts) were created on porcine myocardial slabs by using an open-tip irrigated ablation catheter with the following settings: 35 W with either intermittent (varied between 0 and up to 20 g), variable (10 to 20 g), or constant tissue contact (15 g) in a perpendicular or parallel fashion (applied manually) up to a target LSI of either 5 or 6. Subsequently, lesion width and depth were determined. Lesion width was mainly influenced by catheter tip orientation and LSI, whereas lesion depth was mainly influenced by LSI alone. The force stability of catheter contact had no relevant impact on lesion width or depth. CONCLUSION: The force stability of catheter contact has only little effect on lesion depth or width in LSI-guided catheter ablation while the catheter orientation primarily affects lesion width.

The role of Cor-Knot in the future of cardiac surgery: A systematic review.

OBJECTIVE: The Cor-Knot automated fastener has been used to eliminate the need for manual knot-tying in cardiac valve surgery for over a decade. We review the current literature pertaining to Cor-Knot and discuss its benefits and shortcomings with respect to cardiac valve surgery. METHODS: A comprehensive literature search was conducted to identify articles discussing the use of automated fasteners and manually tied knots in the setting of cardiac valve surgery. The search terms used were "heart", "valve surgery", "cardiac", "Cor-Knot", "fastener", "automated fastener", "aortic valve", "mitral valve", "minimally invasive", and "titanium". These terms were used as keywords and, in combination, as MeSH terms to maximize the output of literature searches. Twenty-four relevant articles were identified and reviewed. RESULTS: Current literature provides evidence to support the role of Cor-Knot in facilitating enhanced intraoperative efficacy by reducing total operation times as compared with manual knot-tying. However, studies to date fail to provide evidence for the translation of these intraoperative advantages into improved patient outcomes. Moreover, Cor-Knot is associated with a significant financial burden. CONCLUSION: A plethora of evidence exists to support the intraoperative advantages provided by Cor-Knot. However, the literature is yet to support its role in facilitating superior clinical outcomes as compared with manual knot tying. Larger high-quality trials and studies are required to provide evidence supporting the ongoing use of Cor-Knot in valve surgery.

Patent foramen ovale closure for secondary stroke prevention.

Transcatheter closure of patent foramen ovale (PFO) in patients with cryptogenic stroke is gaining momentum after the recent publication of four randomized clinical trials suggesting its benefit. This article provides a contemporary overview of the anatomy and pathophysiology of PFO, the available diagnostic tools for the assessment and risk stratification of PFO, and the current and future landscape of PFO closure devices and their optimal utilization. It also summarizes the current data on PFO closure for stroke prevention, and discusses the remaining open issues in the field of PFO closure.

Sinus Superflex DS© early collapse in systemic arterial duct.

We implanted two sinus Superflex DS© stents in a systemic non-stenotic arterial duct of a newborn with hypoplastic left heart syndrome. Forty-eight hours later an important collapse of the stent was detected and treated with a balloon expandable stent. Sinus Superflex DS© has been specifically designed for systemic ducts. This complication generates doubts about its radial force in this scenario.

Behavior of a dual closed-loop controller of propofol and remifentanil guided by the bispectral index for postoperative sedation of adult cardiac surgery patients: a preliminary open study.

A dual-loop controller permits the automated titration of propofol and remifentanil during anesthesia; it has never been used in intensive care after cardiac surgery. The goal of this preliminary study was to determine the efficacy of this controller to provide postoperative sedation in 19 adult cardiac surgery patients with a Bispectral Index target of 50. Results are presented as numbers (percentages) or medians [25th-75th percentiles]. The sedation period lasted 139 min [89-205] during which the Richmond Agitation Sedation Scale was at - 5 and the Behavioral Pain Scale score at three points for all patients and observation times but one (82 out of 83 assessments). Sedation time in the range 40-60 for the Bispectral Index was 87% [57-95]; one patient had a period of electrical silence defined as Suppression Ratio at least > 10% for more than 60 s. The time between the end of infusions and tracheal extubation was 84 min [63-129]. The Richmond Agitation Sedation Scale was 0 [0-0], 0 [- 1 to 0], and 0 [0-0] respectively during the 3 h following extubation while the verbal numerical pain scores were 6 [4.5-7], 5 [4-6], and 2 [0-5]. Mean arterial pressure decreased during sedation requiring therapeutic interventions, mainly vascular filling in 15 (79%) patients. Automated sedation device was discontinued in two patients for hemodynamic instability. No patient had awareness of the postoperative sedation period. Dual closed-loop can provide postoperative sedation after cardiac surgery but the choice of the depth of sedation should take into account the risk of hypotension.

Left Atrial Appendage Closure in Patients With Intracranial Hemorrhage and Nonvalvular Atrial Fibrillation.

BACKGROUND: Left atrial appendage (LAA) closure is primarily performed in patients who have contraindications to anticoagulants. However, anticoagulants are recommended for the first few weeks after LAA closure to prevent the device related thrombus. Purpose of this study was to evaluate if short term use of anticoagulant is safe and effective after LAA closure in patients with a history of intracranial hemorrhage. METHODS: It is a retrospective observational study done at a single center. Baseline characteristics, perioperative, and postoperative complications of patients with a history of intracranial hemorrhage and Watchman device implant were analyzed, and patients were followed for a mean follow-up of 27 months. RESULTS: LAA closure was performed in 16 patients using the Watchman device (Boston Scientific, MA). Mean age was 74.6 ± 5.8 years, median CHA2DS2-VASc score was 4.5 (interquartile range of 3), median HAS-BLED score was 4 (interquartile range of 1). Patients received aspirin 81 mg with oral anticoagulant for 45 days, dual antiplatelet therapy for 4.5 months, and thereafter aspirin indefinitely. No perioperative and postoperative complications were noted. CONCLUSION: Based on our single center experience, we conclude that antithrombotic drugs in the short term appear safe and effective in selected patients after LAA closure in patients with previous intracranial hemorrhage.

Experimental Study with Regard to the Effects of Energy Titration of the Laserballoon on the Lesion Creation Using Porcine Myocardium.

Laserballoon-based pulmonary vein isolation has proven to be safe and effective. However, the influence of the laser energy titration on the lesion formation has never been fully investigated. The aim of this study was to determine the relationship between the delivered laser energy and lesion size, as well as the incidence of steam pop.The whole porcine heart was excised, and the left ventricular myocardium was separated into four specimens. Myocardial specimens were embedded in a warm mattress to keep the myocardial temperature around 37°C. The laserballoon was located so that the surface of the laserballoon was attached to the myocardium. The laser energy was irradiated against the surface of myocardium at 5.5, 8.5, 10.0, and 12.0 W for 3, 5, 10, and 20 seconds. The depth, surface area, and lesion volume were measured using a digital vernier caliper.At constant laser energy and time, the lesion size increased significantly with the increasing energy (P < 0.001) and application duration (P < 0.001). The steam pop was provoked when a 12.0 W laser energy was applied for longer than 16 seconds, and it occurred in 2 out of 8 lesions.The laserballoon demonstrated the ability to create a lesion formation in a dose- and time-dependent manner. Steam pop could be provoked with high-energy irradiation.