View clinical trials related to Pacemaker Implantation.
Filter by:Current practice is to implant cardiac electronic devices using intravenous sedation with midazolam and fentanyl, as well as local injection of anesthetic (1-2). However, some patients do not tolerate sedation and develop nausea/vomiting, delirium/confusion, allergic reactions, and hemodynamic instability with sedation (2-4). Many patients are poor candidates for procedural sedation due to inadequate fasting before the procedure or prior adverse effects of procedural sedation. Pain control is usually adequate, but a large portion of patients still experience pain or discomfort at the implant site if the local anesthetic did not reach every component of the tissue in the surgical field. Meanwhile, nerve block procedures have been used for decades to improve peri-operative and post-operative pain and reduce sedation requirements. With the introduction of ultrasound, the investigators are able to direct delivery of local anesthetic to anesthetize the supraclavicular and pectoralis nerves that supply sensory/pain sensation to the surgical site. Similar techniques have been well described as safe and effective (5-10). The investigators hypothesize this will improve pain control during and after surgery, reduce or eliminate the need for intravenous sedation and improve the safety of the procedure.
The investigators propose to carry out an observational study of patients implanted with a pacemaker using AAI SafeR® mode after a TAVI procedure. This study aims to define the persistence or not of high-grade AVB beyond seven days after the procedure, based on the analysis of PM memories, and define definitive cardiac pacing indications after TAVI procedure.
The purpose of this study is to assess the incidence (at 90-days) of ventricular pacing in patients undergoing permanent pacemaker placement after TAVR. As well as incidence (at 90-days) of atrioventricular block (AVB), intraventricular conduction delay (IVCD), bundle branch block (BBB), and rate histogram in patients undergoing permanent pacemaker placement after TAVR.
The investigators believe that the local anesthetic EMLA (Lidocaine 2.5% and Prilocaine 2.5%) cream will lessen pain and reduce the need for anesthesia and analgesia, when implanting a permanent pacemaker.
The aim of this study is to demonstrate the efficacy of fibrin sealant (Tissucol-Baxter) in preventing pocket haematoma and subsequent complications in patients undergoing pacemaker or ICD implantation/replacement which cannot discontinue dual antiplatelet therapy (i.e. ASA and clopidogrel, ASA and prasugrel) or anticoagulant therapy (i.e. warfarin, heparin, low molecular weight heparin). Fibrin-based sealant is available for local haemostasis. A recent study (Milic DJ et al, 2005 Europace, 7: 374-379) has shown the efficacy of the fibrin sealant in prevention of pacemaker pocket haematoma in 40 patients undergoing pacemaker implantation who are receiving anticoagulant treatment. Patients with dual antiplatelet therapy (DAT) are prone to a high risk of bleeding during surgical procedures. Thus, the routine use is the discontinuation of DAT al least 4-7 days before the intervention. This practice may result in a high risk of thrombotic events in patients with coronary stenting. Recently, in our Center we started the use of a fibrin sealant for local haemostasis (Tissucol Baxter), and the investigators observed a reduction in the incidence of pocket haematoma complication, the need of vacuum drainage system, and the reduction of hospital stay.