The New 3D Printed Left Atrial Appendage Closure with a Novel Holdfast Device: A Pre-Clinical Feasibility Animal Study.

INTRODUCTION: Many patients undergoing cardiac surgery have risk factors for both atrial fibrillation (AF) and stroke. The left atrial appendage (LAA) is the primary site for thrombi formation. The most severe complication of emboli derived from LAA is stroke, which is associated with a 12-month mortality rate of 38% and a 12-month recurrence rate of 17%. The most common form of treatment for atrial fibrillation and stroke prevention is the pharmacological therapy with anticoagulants. Nonetheless this form of therapy is associated with high risk of major bleeding. Therefore LAA occlusion devices should be tested for their ability to reduce future cerebral ischemic events in patients with high-risk of haemorrhage. AIM: The aim of this study was to evaluate the safety and feasibility of a novel left atrial appendage exclusion device with a minimally invasive introducer in a swine model. MATERIALS AND METHODS: A completely novel LAA device, which is composed of two tubes connected together using a specially created bail, was designed using finite element modelling (FEM) to obtain an optimal support force of 36 N at the closure line. The monolithic form of the occluder was obtained by using additive manufacturing of granular PA2200 powder with the technology of selective laser sintering (SLS). Fifteen swine were included in the feasibility tests, with 10 animals undergoing fourteen days of follow-up and 5 animals undergoing long-term observation of 3 months. For one animal, the follow-up was further prolonged to 6 months. The device was placed via minithoracotomy. After the observation period, all of the animals were euthanized, and their hearts were tested for LAA closure and local inflammatory and tissue response. RESULTS: After the defined observation period, all fifteen hearts were explanted. In all cases the full closure of the LAA was achieved. The macroscopic and microscopic evaluation of the explanted hearts showed that all devices were securely integrated in the surrounding tissues. No pericarditis or macroscopic signs of inflammation at the site of the device were found. All pigs were in good condition with normal weight gain and no other clinical symptoms. CONCLUSION: This novel 3D printed left atrial appendage closure technique with a novel holdfast device was proven to be safe and feasible in all pigs. A benign healing process without inflammation and damage to the surrounding structures or evidence of new thrombi formation was observed. Moreover, the uncomplicated survival and full LAA exclusion in all animals demonstrate the efficacy of this novel and relatively cheap device. Further clinical evaluation and implementation studies should be performed to introduce this new technology into clinical practice.

Atrial fibrillation after coronary artery bypass grafting without cardiopulmonary bypass.

OBJECTIVE: Atrial fibrillation is the most common complication after heart surgery. It rarely has a fatal outcome but causes patient instability, prolongs hospital stay, or even is the reason for perioperative infarction. Although conventional coronary artery bypass grafting (CABG) with cardiopulmonary bypass has excellent short-term and long-term results, the number of coronary operations on a beating heart without cardiopulmonary bypass is still growing. To reduce surgical trauma, off-pump coronary artery bypass grafting via sternotomy (OPCABG) or minimally invasive direct vision coronary artery bypass grafting (MIDCABG) via small thoracotomy are performed. The aim of this study was to estimate the frequency of atrial fibrillation in patients after myocardial revascularization without cardiopulmonary bypass. METHODS: A retrospective analysis of 48 patients undergoing myocardial revascularization without cardiopulmonary bypass was performed. Twenty-four patients underwent OPCABG and 24 were operated using the MIDCABG technique. The incidence of cardiac arrhythmias was analyzed since operation to the fourth postoperative day. Each patient had continuous ECG monitoring with option of arrhythmia analysis during ICU stay. After discharge from ICU 24-h ECG monitor studies were carried out. Surface 12-lead ECG was accomplished once a day, and additionally each time symptoms of cardiac arrhythmia occurred. Risk factors of atrial fibrillation were estimated. RESULTS: Atrial fibrillation occurred in 25% of patients after MIDCABG, in 29% after OPCABG, and in 18% after CABG with cardiopulmonary bypass. This difference has no statistical significance. Risk factors and incidence of postoperative complications were comparable in all groups. CONCLUSIONS: Atrial fibrillation is a common complication after procedures of myocardial revascularization, performed with or without cardiopulmonary bypass. The occurrence is not dependent on the type of operation.

Thermographic assessment of stellate ganglion block effectiveness during cardiosurgical procedures.

UNLABELLED: The study present thermographic assessment of the effectiveness of temporary stellate blockade performed during cardiosurgical procedures. The assumption behind this method was the increase in the temperature of upper extremity on the side of blockade, due to the broadening of arterial bed. MATERIAL AND METHOD: The study was conducted on a group of 30 patients (21 men and 9 women) operated due to coronary disease involving three vessels. Mean age of the patients was 53 years. After introduction of anaesthesia blockade were performed with 2 ml 2% lignocainum and 8 ml 0.5% bupivacaine solution using peratracheal approach. Blockade effectiveness was assessed on the basis of images obtained in thermovisual camera, comparing the temperatures of upper extremity before and within 15 minutes after performing the blockade. Free blood outflow from radial artery, its diameter and length were also evaluated. The results obtained were subject to statistical analysis. RESULTS: Twenty-three patients (76.6%) displayed the increase in the temperature of upper extremity by 1-3 degrees C. Free blood outflow from radial artery was greater in this group than in the remaining patients. CONCLUSIONS: Thermography is a useful method for the assessment of stellate blockade effectiveness. Effective blockade results in the increased blood flow in radial artery.

[Simultaneous coronary artery bypass grafting on the beating heart without assisted circulation and radical modified Patey mastectomy--case report]. / Jednoczasowa operacja rewaskularyzacji naczyn wiencowych na bijacym sercu bez krazenia pozaustrojowego i radykalnej zmodyfikowanej amputacji sutka sposobem Pateya--opis przypadku.

A case of 53-year-old female with unstable angina pectoris and primary right breast cancer is presented. Simultaneous operation including coronary artery bypass grafting and modified radical mastectomy was performed. On the beating heart coronary anastomoses were done without cardiopulmonary bypass (CPB) through median sternotomy (OPCABG). Immediately after OPCABG cancer operation was performed under stable hemodynamics without any bleeding tendency. There were neither perioperative nor postoperative complications noticed. Three months after operation adjuvant local radiotherapy was started. Concomitant surgical treatment seems to be safe and beneficial in carefully selected patients who have surgically correctable coronary artery disease and potentially curable breast cancer.

[Less invasive coronary artery bypass grafting]. / Mniej inwazyjne zabiegi przeslowania aortalno-wiencowego.

Myocardial revascularization had its beginnings in the early 1900s with extracardiac operations, such as sympathetic denervation and thyroid ablation. Since than it evolved to saphenous vein- and mammary artery-coronary artery bypass grafting (CABG) on the beating heart in the 1960s and after 1975 with the use of cardiopulmonary bypass (CPB) and cardioplegic arrest. Although excellent short-term and long-term results have been obtained with conventional CABG on cardiopulmonary bypass, there is still significant mortality and morbidity associated with the procedure, especially in the higher risk patients. To reduce surgical trauma off-pump coronary artery bypass grafting (OPCABG) and minimally invasive direct vision coronary artery bypass grafting (MIDCABG) are performed. Totally endoscopic operations are still in experimental stage. In the article optional less invasive surgical techniques are described.

[Diagnostic difficulties in spontaneous rupture of the urinary bladder]. / Trudnosci rozpoznawcze w samoistnym peknieciu pecherza moczowego.

A 63-year-old female patient is described with spontaneous rupture of the urinary bladder who was admitted to hospital with signs of diffuse peritonitis. During surgical operation the site of perforation could not be found, and only inflammatory infiltration of the urinary bladder and surrounding tissues was observed. Cystography carried out after the operation revealed the site of perforation only after six hours from the administration of contrast medium. It was sutured during secondary operation. The postoperative course was uncomplicated.