Watchman device

All consecutive patients successfully implanted with an LAAO device using either the Amplatzer Cardiac Plug (ACP) device (St. Jude Medical, Minneapolis, MN, USA) or the Watchman device (Boston Scientific, Natick, MA, USA) were included in a prospective single-center study at Dijon University Hospital for a period of four years. A complete screening with all clinical and paraclinical signs of the implanted patients was noted before the procedure, just like the data concerning the percutaneous intervention. A contrast-enhanced cardiac computed tomography (CT) was performed before and 6 weeks after the procedure with reverse left atrial remodeling defined by an increase in LA volume >10%. A blood sampling was obtained before, 48 h after device implantation and at the first visit after discharge (30–45 days) for BNP measurement. Major adverse cardiac events (MACEs) were collected after device implantation and during the follow-up.
After 6 weeks, patients were classified according to the presence or absence of left atrial remodeling, based on the second CT evaluation.
The study sample consisted of 43 patients, with at least one-year follow-up. The flow chart is shown in Figure 1.

A 74-year-old male was initially referred to our cardiology department to evaluate the indication for percutaneous LAA closure in the presence of a contraindication to OAC as therapy for AF. The patient had a history of bradycardia which required a VVI pacemaker, haemorrhagic stroke and ocular infarction. In spite of a CHA2DS2-VASC score of 3, OAC was contraindicated due to a previous haemorrhagic stroke. The patient was accepted for percutaneous LAA closure using the Watchman device (Boston Scientific, Marlborough, MA, USA). During the percutaneous procedure multiple attempts were performed for adequate placement of the device. However, due to recurrent dislocation this procedure was terminated. Subsequently, the patient was referred to the cardiothoracic surgery department for thoracoscopic epicardial closure of the LAA.

Under general anesthesia and standard monitoring, the Watchman device (Boston Scientific Corp, Marlborough, MA, USA) was implanted at the ostium of the LAA via a transseptal puncture and through femoral access, as described [21 (link)].

Consecutive NVAF patients who underwent percutaneous LAAC with the WATCHMAN® device (Boston Scientific, Marlborough, MA, USA) at Helmut-G.-Walther Klinikum, Lichtenfels, Germany were enrolled in an observational registry between February 2012 and June 2018. The major inclusion criteria for LAAC procedure were patients with high risk of cardioembolism and/or contraindication for long-term anticoagulation therapy, or unwillingness to take anticoagulation drugs. Those who suffered from malignant tumor or end stage diseases with life expectancy shorter than 1 year or presented with thrombus in the left atria/left atrial appendage were excluded. The study protocol complies with the Declaration of Helsinki and was approved by the Ethics Committee at Helmut-G.-Walther Klinikum, Lichtenfels, Germany. All patients provided written informed consent for the device implantation. The cohort was divided into two groups: stroke group (patients with a history of prior stroke) and non-stroke group (patients without a history of prior stroke). An analysis of demographic and clinical characteristics, peri-procedural data, and long-term outcomes was performed for all patients.

The ICE-guided LAAC was performed as previously described [11 (link)]. The intracardiac images for reconstructing the three-dimensional left atrium model were obtained using a 10-F SoundStar ICE catheter (Biosense Webster). Briefly, the right femoral access was first constructed, and an 11-F sheath for advancing the ICE catheter was inserted into the middle of the right atrium. The catheter was rotated until the atrial septal was fully visible. Finally, the posterior and inferior areas of the fossa ovalis were punctured. The delivery device to the sheath was advanced to the left atrium through the punctured hole. In addition, during the LAAC procedure, the ICE probe was advanced into the left atrium through the same atrial septal puncture hole. The WATCHMAN device (Boston Scientific) was used for the procedure. If the LAA morphology was unsuitable for the WATCHMAN device implantation, the LACbes device (PushMed, Shanghai, China) was instead implanted. Both sheaths have a diameter of 12-F. The diagrammatic flow of these steps is shown in Figure 2.

Intracardiac echocardiography (ICE)-guided LAAO was performed as previously described [12 (link)]. In brief, the radiofrequency catheter was replaced with a device delivery sheath. An ICE probe was advanced into the left atrium along with the device delivery sheath through the same atrial septal puncture hole. Left atrial appendage (LAA) morphology was first acquired to confirm that the device that was selected before the procedure was appropriate. Then, the closure device was implanted under the guidance of ICE. During occlusion, prominent edema of the coumadin ridge was seen (Figure 1D). Both a Watchman device (Boston Scientific) and a LACbes device (PushMed, Shanghai, China) were used as alternatives. If occlusion was appropriate, the closure device was released. At the end of the LAAO procedure, hemostasis was ensured by manual compression.