In a pivotal trial (NCT05252702), the AVEIR DR (Abbott) leadless pacemaker system was found to be safe and effective in delivering DDDR synchronous atrial and ventricular pacing. This dual-chamber system employs 2 leadless pacemakers with implant-to-implant communication. Although implantation of the ventricular device as a single-chamber pacemaker has been well described, there are additional considerations surrounding the dual-chamber implantation procedure. Herein, we review the dual-chamber leadless pacemaker implantation workflow while providing guidance to optimize safe and effective implantation procedures.

• MeSH
• Equipment Design * MeSH
• Prosthesis Implantation methods   instrumentation   MeSH
• Cardiac Pacing, Artificial methods   MeSH
• Pacemaker, Artificial * MeSH
• Humans MeSH
• Check Tag
• Humans MeSH
• Publication type
• Journal Article MeSH
• Review MeSH

BACKGROUND: Cardiac implantable electronic device (CIED) implantation rates as well as the clinical and procedural characteristics and outcomes in patients with known active coronavirus disease 2019 (COVID-19) are unknown. OBJECTIVE: The purpose of this study was to gather information regarding CIED procedures during active COVID-19, performed with personal protective equipment, based on an international survey. METHODS: Fifty-three centers from 13 countries across 4 continents provided information on 166 patients with known active COVID-19 who underwent a CIED procedure. RESULTS: The CIED procedure rate in 133,655 hospitalized COVID-19 patients ranged from 0 to 16.2 per 1000 patients (P <.001). Most devices were implanted due to high-degree/complete atrioventricular block (112 [67.5%]) or sick sinus syndrome (31 [18.7%]). Of the 166 patients in the study survey, the 30-day complication rate was 13.9% and the 180-day mortality rate was 9.6%. One patient had a fatal outcome as a direct result of the procedure. Differences in patient and procedural characteristics and outcomes were found between Europe and North America. An older population (76.6 vs 66 years; P <.001) with a nonsignificant higher complication rate (16.5% vs 7.7%; P = .2) was observed in Europe vs North America, whereas higher rates of critically ill patients (33.3% vs 3.3%; P <.001) and mortality (26.9% vs 5%; P = .002) were observed in North America vs Europe. CONCLUSION: CIED procedure rates during known active COVID-19 disease varied greatly, from 0 to 16.2 per 1000 hospitalized COVID-19 patients worldwide. Patients with active COVID-19 infection who underwent CIED implantation had high complication and mortality rates. Operators should take these risks into consideration before proceeding with CIED implantation in active COVID-19 patients.

• MeSH
• Atrioventricular Block * epidemiology   therapy   MeSH
• Global Health statistics & numerical data   MeSH
• COVID-19 * diagnosis   epidemiology   therapy   MeSH
• Defibrillators, Implantable statistics & numerical data   MeSH
• Outcome Assessment, Health Care MeSH
• Prosthesis Implantation * adverse effects   instrumentation   mortality   MeSH
• Pacemaker, Artificial statistics & numerical data   MeSH
• Comorbidity MeSH
• Infection Control * instrumentation   methods   organization & administration   MeSH
• Middle Aged MeSH
• Humans MeSH
• Mortality MeSH
• Postoperative Complications * diagnosis   mortality   MeSH
• Surveys and Questionnaires MeSH
• Risk Factors MeSH
• SARS-CoV-2 isolation & purification   MeSH
• Aged MeSH
• Sick Sinus Syndrome * epidemiology   therapy   MeSH
• Check Tag
• Middle Aged MeSH
• Humans MeSH
• Male MeSH
• Aged MeSH
• Female MeSH
• Publication type
• Journal Article MeSH

BACKGROUND: Percutaneous left atrial appendage closure (LAAC) is noninferior to vitamin K antagonists (VKAs) for preventing atrial fibrillation (AF)-related stroke. However, direct oral anticoagulants (DOACs) have an improved safety profile over VKAs, and their effect on cardiovascular and neurological outcomes relative to LAAC is unknown. OBJECTIVES: This study sought to compare DOACs with LAAC in high-risk patients with AF. METHODS: Left Atrial Appendage Closure vs. Novel Anticoagulation Agents in Atrial Fibrillation (PRAGUE-17) was a multicenter, randomized, noninferiority trial comparing LAAC with DOACs. Patients were eligible to be enrolled if they had nonvalvular AF; were indicated for oral anticoagulation (OAC); and had a history of bleeding requiring intervention or hospitalization, a history of a cardioembolic event while taking an OAC, and/or a CHA2DS2-VASc of ≥3 and HAS-BLED of >2. Patients were randomized to receive LAAC or DOAC. The primary composite outcome was stroke, transient ischemic attack, systemic embolism, cardiovascular death, major or nonmajor clinically relevant bleeding, or procedure-/device-related complications. The primary analysis was by modified intention to treat. RESULTS: A high-risk patient cohort (CHA2DS2-VASc: 4.7 ± 1.5) was randomized to receive LAAC (n = 201) or DOAC (n = 201). LAAC was successful in 181 of 201 (90.0%) patients. In the DOAC group, apixaban was most frequently used (192 of 201; 95.5%). At a median 19.9 months of follow-up, the annual rates of the primary outcome were 10.99% with LAAC and 13.42% with DOAC (subdistribution hazard ratio [sHR]: 0.84; 95% confidence interval [CI]: 0.53 to 1.31; p = 0.44; p = 0.004 for noninferiority). There were no differences between groups for the components of the composite endpoint: all-stroke/TIA (sHR: 1.00; 95% CI: 0.40 to 2.51), clinically significant bleeding (sHR: 0.81; 95% CI: 0.44 to 1.52), and cardiovascular death (sHR: 0.75; 95% CI: 0.34 to 1.62). Major LAAC-related complications occurred in 9 (4.5%) patients. CONCLUSIONS: Among patients at high risk for stroke and increased risk of bleeding, LAAC was noninferior to DOAC in preventing major AF-related cardiovascular, neurological, and bleeding events. (Left Atrial Appendage Closure vs. Novel Anticoagulation Agents in Atrial Fibrillation [PRAGUE-17]; NCT02426944).

• MeSH
• Stroke * etiology   prevention & control   MeSH
• Atrial Fibrillation complications   diagnosis   drug therapy   surgery   MeSH
• Prosthesis Implantation * adverse effects   instrumentation   methods   MeSH
• Factor Xa Inhibitors * administration & dosage   adverse effects   MeSH
• Cardiac Surgical Procedures * adverse effects   instrumentation   methods   MeSH
• Hemorrhage * chemically induced   prevention & control   MeSH
• Humans MeSH
• Aged MeSH
• Atrial Appendage diagnostic imaging   surgery   MeSH
• Outcome and Process Assessment, Health Care MeSH
• Check Tag
• Humans MeSH
• Male MeSH
• Aged MeSH
• Female MeSH
• Publication type
• Journal Article MeSH
• Multicenter Study MeSH
• Research Support, Non-U.S. Gov't MeSH
• Randomized Controlled Trial MeSH

Objectives: Development of right ventricular failure (RVF) after left ventricular assist device (LVAD) implantation remains a leading cause of perioperative morbidity, end-organ dysfunction and mortality. The objective of this study was to investigate whether the etiology of HF (ischemic HF versus non-ischemic HF) affects the risk of RVF within admission for LVAD implantation and during long-term follow-up. Methods: Between January 2011 and June 27, 2018, 3536 patients were prospectively enrolled into EUROMACS registry. Adult patients (>18 years) who received a first time LVAD were included. When excluding patients with congenital, restrictive, hypertrophic, valvular cardiomyopathies, and myocarditis the total population consisted of 2404 patients. Results: The total cohort consists of 2404 patients. Mean age were 55 years and predominantly male sex [2024 (84.2%)]. At the time of LVAD implantation 1355 (56.4%) patients had ischemic HF and 1049 (43.6%) patients had non-ischemic HF. The incidence of RVF was significantly increased in the non-ischemic HF group in the adjusted model (p = .026). The relative risk difference for RVF in patients with non-ischemic HF was in the adjusted model increased by an absolute value of 5.1% (95% CI: 0.61-9.6). In the ischemic HF group 76 patients (13.4%) developed late RVF and 62 patients (14.8%) in the non-ischemic HF group (p = .56). No differences in occurrence of RVF between HF etiology was observed after 2 and 4 years of follow-up, respectively (crude: p = .25, adjusted (sex and age) p = .2 and crude: p = .59, adjusted (sex and age) p = .44). Conclusions: Patients with non-ischemic HF undergoing LVAD had an increased incidence of early RVF compared to patients with ischemic HF in a large European population. During follow-up after discharge 14% patients developed RVF. We recommend HF etiology to be considered in identifying patients who are at risk for postoperative RVF after LVAD implantation.

• MeSH
• Time Factors MeSH
• Adult MeSH
• Ventricular Dysfunction, Right diagnostic imaging   epidemiology   physiopathology   MeSH
• Ventricular Function, Left * MeSH
• Ventricular Function, Right * MeSH
• Risk Assessment MeSH
• Prosthesis Implantation adverse effects   instrumentation   MeSH
• Incidence MeSH
• Middle Aged MeSH
• Humans MeSH
• Heart-Assist Devices * MeSH
• Registries MeSH
• Risk Factors MeSH
• Heart Failure diagnostic imaging   epidemiology   physiopathology   therapy   MeSH
• Treatment Outcome MeSH
• Check Tag
• Adult MeSH
• Middle Aged MeSH
• Humans MeSH
• Male MeSH
• Female MeSH
• Publication type
• Journal Article MeSH
• Multicenter Study MeSH
• Comparative Study MeSH
• Geographicals
• Europe MeSH

• MeSH
• Time Factors MeSH
• Ventricular Function, Left * MeSH
• Risk Assessment MeSH
• Prosthesis Implantation adverse effects   instrumentation   mortality   standards   MeSH
• Cardiology standards   MeSH
• Clinical Decision-Making MeSH
• Consensus MeSH
• Humans MeSH
• Evidence-Based Medicine standards   MeSH
• Recovery of Function MeSH
• Heart-Assist Devices standards   MeSH
• Prosthesis Design standards   MeSH
• Risk Factors MeSH
• Waiting Lists * mortality   MeSH
• Heart Failure diagnosis   mortality   physiopathology   therapy   MeSH
• Lung Transplantation adverse effects   mortality   standards   MeSH
• Heart Transplantation adverse effects   mortality   standards   MeSH
• Patient Selection MeSH
• Treatment Outcome MeSH
• Check Tag
• Humans MeSH
• Publication type
• Journal Article MeSH
• Review MeSH
• Practice Guideline MeSH

Long-term mechanical circulatory support (LT-MCS) is an important treatment modality for patients with severe heart failure. Different devices are available, and many-sometimes contradictory-observations regarding patient selection, surgical techniques, perioperative management and follow-up have been published. With the growing expertise in this field, the European Association for Cardio-Thoracic Surgery (EACTS) recognized a need for a structured multidisciplinary consensus about the approach to patients with LT-MCS. However, the evidence published so far is insufficient to allow for generation of meaningful guidelines complying with EACTS requirements. Instead, the EACTS presents an expert opinion in the LT-MCS field. This expert opinion addresses patient evaluation and preoperative optimization as well as management of cardiac and non-cardiac comorbidities. Further, extensive operative implantation techniques are summarized and evaluated by leading experts, depending on both patient characteristics and device selection. The faculty recognized that postoperative management is multidisciplinary and includes aspects of intensive care unit stay, rehabilitation, ambulatory care, myocardial recovery and end-of-life care and mirrored this fact in this paper. Additionally, the opinions of experts on diagnosis and management of adverse events including bleeding, cerebrovascular accidents and device malfunction are presented. In this expert consensus, the evidence for the complete management from patient selection to end-of-life care is carefully reviewed with the aim of guiding clinicians in optimizing management of patients considered for or supported by an LT-MCS device.

• MeSH
• Prosthesis Implantation instrumentation   methods   MeSH
• Cardiac Surgical Procedures instrumentation   methods   MeSH
• Humans MeSH
• Perioperative Care methods   MeSH
• Heart-Assist Devices * MeSH
• Postoperative Complications diagnosis   therapy   MeSH
• Heart Failure complications   diagnosis   surgery   MeSH
• Check Tag
• Humans MeSH
• Publication type
• Journal Article MeSH
• Consensus Development Conference MeSH

Aims: No standard practice exists with respect to anaesthesiologist-directed sedation (ADS) vs. sedation by proceduralist (PDS) for defibrillation threshold (DT) testing. We aimed to evaluate adverse events and safety outcomes with ADS vs. PDS for DT testing. Methods and results: A post hoc analysis of the Shockless Implant Evaluation (SIMPLE) study was performed among the 1242 patients who had DT testing (624 ADS and 618 PDS). We evaluated both intraoperative and in-hospital adverse composite events and two safety composite outcomes at 30-days of the main trial. Propensity score adjusted models were used to compute odds ratio (OR) and 95% confidence interval (CI) to evaluate the association between adverse and safety outcomes with method of sedation and independent predictors for use of ADS. Compared to PDS, patients who received ADS were younger (62 ± 12 years vs. 64 ± 12 years, P = 0.01), had lower ejection fraction (left ventricular ejection fraction 0.31 ± 13 vs. 0.33 ± 13, P = 0.03), were more likely to receive inhalational anaesthesia, propofol, or narcotics (P < 0.001, respectively) and receive an arterial line (43% vs. 8%, P = <0.0001). Independent predictors for ADS sedation were presence of coronary artery disease (OR 1.69, 95% CI 1.0-2.72; P = 0.03) and hypertrophic cardiomyopathy (OR 2.64, 95% CI 1.19-5.85; P = 0.02). Anaesthesiologist directed sedation had higher intraoperative adverse events (2.2% vs. 0.5%; OR 4.47, 95% CI 1.25-16.0; P = 0.02) and higher primary safety outcomes at 30 days (8.2% vs. 4.9%; OR 1.72 95% CI 1.06-2.80; P = 0.03) and no difference in other outcomes compared to PDS. Conclusion: Proceduralist-directed sedation is safe, however, this could be result of selection bias. Further research is needed.

• MeSH
• Conscious Sedation * adverse effects   methods   MeSH
• Defibrillators, Implantable * MeSH
• Ventricular Fibrillation therapy   MeSH
• Risk Assessment MeSH
• Hypnotics and Sedatives * administration & dosage   adverse effects   MeSH
• Prosthesis Implantation * adverse effects   instrumentation   methods   MeSH
• Middle Aged MeSH
• Humans MeSH
• Death, Sudden, Cardiac etiology   prevention & control   MeSH
• Postoperative Complications * diagnosis   epidemiology   etiology   MeSH
• Risk Factors MeSH
• Aged MeSH
• Outcome and Process Assessment, Health Care MeSH
• Check Tag
• Middle Aged MeSH
• Humans MeSH
• Male MeSH
• Aged MeSH
• Female MeSH
• Publication type
• Journal Article MeSH
• Randomized Controlled Trial MeSH

With the recent advances in computer-aided technologies and their breach into the medical field, there can be seen more and more successful outcomes, especially in the files of reconstructive prosthetic surgery. With the application of advanced tools for reconstruction of complex shape such as human anatomy, it allowed accurate and fast design of complex implants as a substitution for deformed or damaged regions in the field of maxillofacial surgery. Design, in compliance with application of additive manufacturing (AM) technologies, is starting to gain more recognition as a tool for fast and accurate delivery of patient-specific 3D implants. This paper present a case study where such 3D technologies are used to design and fabricate a patient-specific mandibular implant. Tools for design of complex anatomical surfaces, such as mandible are presented and demonstrated in this paper. As the verification stage, AM technologies are used for visual inspection and surgical procedure planning of the designed 3D model of the mandibular implant.

• MeSH
• Printing, Three-Dimensional MeSH
• Computer-Aided Design * MeSH
• Prosthesis Implantation methods   instrumentation   MeSH
• Humans MeSH
• Mandibular Prosthesis Implantation * MeSH
• Mandibular Prosthesis * MeSH
• Mandible MeSH
• Mandibular Diseases therapy   MeSH
• Imaging, Three-Dimensional MeSH
• Check Tag
• Humans MeSH

Pacienti snevalvulární fibrilací síní jsou ohroženi zvýšeným rizikem ischemické cévní mozkové příhody asystémového tromboembolismu. Orální antikoagulační terapie je zavedenou prevencí těchto příhod. Unemocných svysokým rizikem krvácení je však méně vhodná nebo kontraindikovaná. Uzávěr ouška levé síně, kde tromby vznikají vevíce než 90 % zevšech lokalizací výskytu, se utěchto pacientů jeví jako vhodná metoda prevence systémových embolizací. Včlánku je podán přehled současného stavu klinicky dominantně používaných metod uzávěru ouška levé síně.

Patients with lone atrial fibrillation are at increased risk of ischemic stroke and the systemic thromboembolism. An established prevention of these events is oral anticoagulation therapy. However, this therapy is less appropriate or contraindicated for patients with ahigh risk of bleeding. Occlussion of the left atrial appendage, where thrombossis originates in more than 90 % of all locations of occurrence, appears to be asuitable method of preventing systemic embolization in these patients. An overview of current state of the clinically dominant methods of occlussion of the left atrial appendage is provided.

• MeSH
• Anticoagulants adverse effects   therapeutic use   MeSH
• Stroke epidemiology   etiology   MeSH
• Atrial Fibrillation diagnostic imaging   complications   MeSH
• Risk Assessment MeSH
• Prosthesis Implantation methods   instrumentation   MeSH
• Catheter Ablation methods   instrumentation   MeSH
• Humans MeSH
• Therapeutic Occlusion methods   MeSH
• Atrial Appendage * surgery   MeSH
• Ischemic Attack, Transient epidemiology   etiology   MeSH
• Thromboembolism etiology   drug therapy   surgery   MeSH
• Check Tag
• Humans MeSH

Aims: Pocket haematoma is a common complication after defibrillator [implantable cardioverter defibrillator (ICD)] implantation, which is not only painful, but also increases the risk of device-related infection, and possibly embolic events. The present study seeks to evaluate the rate and predictors of clinically significant pocket haematoma. Methods and results: This study included 2500 patients receiving an ICD in the SIMPLE trial. A clinically significant pocket haematoma was defined as a haematoma that required re-operation or interruption of oral anticoagulation (OAC) therapy. Clinically significant pocket haematoma occurred in 56 of 2500 patients (2.2%) of which 6 (10.7%) developed device-related infection. Patients who developed pocket haematoma were older (mean age 67.6 ± 8.8 years vs. 62.7 ± 11.6 years, P < 0.001), were more likely to have permanent atrial fibrillation (30.4 vs. 6.7%, P < 0.001) and a history of stroke (17.9 vs. 6.7%, P = 0.004), or were more likely to receive peri-operative OAC (50.0 vs. 28.4%, P < 0.001), unfractionated heparin (16.1 vs. 5.2%, P = 0.003), or low-molecular-weight heparin (37.5 vs. 17.5%, P < 0.001). Independent predictors of wound haematoma on multivariable analysis included the use of heparin bridging (OR 2.65, 95% CI 1.48-4.73, P = 0.001), sub-pectoral location of ICD (OR 2.00, 95% CI 1.12-3.57, P =0.020), previous stroke (OR 2.47, 95% CI 1.20-5.10, P = 0.015), an upgrade from permanent pacemaker (OR 2.52, 95% CI 1.07-5.94, P = 0.035), and older age (OR 1.03, 95% CI 1.00-1.06, P = 0.049). Conclusion: Pocket haematoma remains an important complication of ICD implantation and is associated with a high risk of infection. Independent predictors of pocket haematoma include heparin bridging, prior stroke, sub-pectoral placement of ICD, older age, and upgrade from a pacemaker.

• MeSH
• Surgical Wound diagnosis   epidemiology   MeSH
• Defibrillators, Implantable * adverse effects   MeSH
• Electric Countershock adverse effects   instrumentation   mortality   MeSH
• Hematoma diagnosis   epidemiology   MeSH
• Heparin administration & dosage   adverse effects   MeSH
• Prosthesis Implantation adverse effects   instrumentation   mortality   MeSH
• Incidence MeSH
• Prosthesis-Related Infections epidemiology   MeSH
• Middle Aged MeSH
• Humans MeSH
• Logistic Models MeSH
• Multivariate Analysis MeSH
• Nonlinear Dynamics MeSH
• Odds Ratio MeSH
• Prospective Studies MeSH
• Risk Factors MeSH
• Chi-Square Distribution MeSH
• Aged MeSH
• Arrhythmias, Cardiac diagnosis   mortality   therapy   MeSH
• Age Factors MeSH
• Treatment Outcome MeSH
• Check Tag
• Middle Aged MeSH
• Humans MeSH
• Male MeSH
• Aged MeSH
• Female MeSH
• Publication type
• Journal Article MeSH
• Multicenter Study MeSH
• Randomized Controlled Trial MeSH