Predicting Major Adverse Events in Patients Undergoing Transcatheter Left Atrial Appendage Occlusion.

BACKGROUND: The National Cardiovascular Data Registry Left Atrial Appendage Occlusion Registry (LAAO) includes the vast majority of transcatheter LAAO procedures performed in the United States. The objective of this study was to develop a model predicting adverse events among patients undergoing LAAO with Watchman FLX. METHODS: Data from 41 001 LAAO procedures with Watchman FLX from July 2020 to September 2021 were used to develop and validate a model predicting in-hospital major adverse events. Randomly selected development (70%, n=28 530) and validation (30%, n=12 471) cohorts were analyzed with 1000 bootstrapped samples, using forward stepwise logistic regression to create the final model. A simplified bedside risk score was also developed using this model. RESULTS: Increased age, female sex, low preprocedure hemoglobin, no prior attempt at atrial fibrillation termination, and increased fall risk most strongly predicted in-hospital major adverse events and were included in the final model along with other clinically relevant variables. The median in-hospital risk-standardized adverse event rate was 1.50% (range, 1.03%-2.84%; interquartile range, 1.42%-1.64%). The model demonstrated moderate discrimination (development C-index, 0.67 [95% CI, 0.65-0.70] and validation C-index, 0.66 [95% CI, 0.62-0.70]) with good calibration. The simplified risk score was well calibrated with risk of in-hospital major adverse events ranging from 0.26% to 3.90% for a score of 0 to 8, respectively. CONCLUSIONS: A transcatheter LAAO risk model using National Cardiovascular Data Registry and LAAO Registry data can predict in-hospital major adverse events, demonstrated consistency across hospitals and can be used for quality improvement efforts. A simple bedside risk score was similarly predictive and may inform shared decision-making.

Watchman device migration and embolization: A report from the NCDR LAAO Registry.

INTRODUCTION: Incomplete anchoring of the Watchman left atrial appendage closure (LAAO) device can result in substantial device migration or device embolization (DME) requiring percutaneous or surgical retrieval. METHODS: We performed a retrospective analysis of Watchman procedures (January 2016 through March 2021) reported to the National Cardiovascular Data Registry LAAO Registry. We excluded patients with prior LAAO interventions, no device released, and missing device information. In-hospital events were assessed among all patients and postdischarge events were assessed among patients with 45-day follow-up. RESULTS: Of 120 278 Watchman procedures, the in-hospital DME rate was 0.07% (n = 84) and surgery was commonly performed (n = 39). In-hospital mortality rate was 14% among patients with DME and 20.5% among patients who underwent surgery. In-hospital DME was more common: at hospitals with a lower median annual procedure volume (24 vs. 41 procedures, p < .0001), with Watchman 2.5 versus Watchman FLX devices (0.08% vs. 0.04%, p = .0048), with larger LAA ostia (median 23 vs. 21 mm, p = .004), and with a smaller difference between device and LAA ostial size (median difference 4 vs. 5 mm, p = .04). Of 98 147 patients with 45-day follow-up, postdischarge DME occurred in 0.06% (n = 54) patients and cardiac surgery was performed in 7.4% (n = 4) of cases. The 45-day mortality rate was 3.7% (n = 2) among patients with postdischarge DME. Postdischarge DME was more common among men (79.7% of events but 58.9% of all procedures, p = .0019), taller patients (177.9 vs. 172 cm, p = .0005), and those with greater body mass (99.9 vs. 85.5 kg, p = .0055). The rhythm at implant was less frequently AF among patients with DME compared to those without (38.9% vs. 46.9%, p = .0098). CONCLUSION: While Watchman DME is rare, it is associated with high mortality and frequently requires surgical retrieval, and a substantial proportion of events occur after discharge. Due to the severity of DME events, risk mitigation strategies and on-site cardiac surgical back-up are of paramount importance.

Antithrombotic Therapy After Left Atrial Appendage Occlusion in Patients With Atrial Fibrillation.

BACKGROUND: Pivotal trials of percutaneous left atrial appendage occlusion (LAAO) used specific postprocedure treatment protocols. OBJECTIVES: This study sought to evaluate patterns of postprocedure care after LAAO with the Watchman device in clinical practice and compare the risk of adverse events for different discharge antithrombotic strategies. METHODS: We evaluated patients in the LAAO Registry of the National Cardiovascular Data Registry who underwent LAAO with the Watchman device between 2016 and 2018. We assessed adherence to the full postprocedure trial protocol including standardized follow-up, imaging, and antithrombotic agents and then evaluated the most commonly used antithrombotic strategies and compared the rates and risk of adverse events at 45 days and 6 months by means of multivariable COX frailty regression. RESULTS: Among 31,994 patients undergoing successful LAAO, only 12.2% received the full postprocedure treatment protocol studied in pivotal trials; the most common protocol deviations were with discharge antithrombotic medications. The most common discharge medication strategies were warfarin and aspirin (36.9%), direct oral anticoagulant (DOAC) and aspirin (20.8%), warfarin only (13.5%), DOAC only (12.3%), and dual antiplatelet therapy (5.0%). In multivariable Cox frailty regression, the adjusted risk of any adverse event through the 45-day follow-up visit were significantly lower for discharge on warfarin alone (HR: 0.692; 95% CI: 0.569-0.841) and DOAC alone (HR: 0.731; 95% CI: 0.574-0.930) compared with warfarin and aspirin. Warfarin alone retained lower risk at the 6-month follow-up. CONCLUSIONS: In contemporary U.S. practice, practitioners rarely used the full U.S. Food and Drug Administration-approved postprocedure treatment protocols studied in pivotal trials of the Watchman device. Discharge after implantation on warfarin or DOAC without concomitant aspirin was associated with lower risk of adverse outcomes.

myHip&Knee: Improving Patient Engagement and Self-Management Through Mobile Technology.

Given the increasing volume of hip and knee replacement surgery with reduced hospital stays and resources, we explored technology to address gaps in patient care and enhance self-management. The team at the Holland Orthopaedic and Arthritic Centre of Sunnybrook Health Sciences Centre, which performs a high volume of joint replacement surgery, partnered with patients and a health technology company to create a mobile app: myHip&Knee. The results to date demonstrate that the app improves patient experience and reduces follow-up calls to surgeons' offices, ultimately reducing demand on healthcare resources. Early engagement of privacy and legal services, close patient and family collaboration and a well-developed evaluation strategy represent critical steps to successful development.

A qualitative study of patient education needs for hip and knee replacement.

BACKGROUND: Quality health information is key to patient engagement, self-management and an enhanced healthcare experience. There is strong evidence to support involving patients and their families in the development and evaluation of health-related educational material. These factors were the impetus for our high volume joint replacement centre to undertake a qualitative study to elicit patient experiences to inform the development of effective strategies and education along the care continuum for hip and knee replacement. METHODS: Purposively selected patients from postoperative follow-up clinics were recruited to participate in a focus group or telephone interview. We developed a semi-structured interview guide that addressed four specific aspects of the patient's experience with educational material: pre-surgery, hospital stay, recovery period and future recommendations. The focus groups and interviews continued to the point of saturation and were audio-recorded and transcribed verbatim. Interview transcripts were coded and then inductively organized into larger categories using thematic analysis. RESULTS: Six focus groups and seven telephone interviews were conducted, totalling 32 participants. One of the key themes that emerged was a need for more education concerning pain management post-operatively; specifically, patients wanted more information on expected levels of pain, pain medication usage, management of side effects and guidelines for weaning off the medication. There was surprising variability in patients' descriptions of their pre-surgery, surgery and recovery experiences. These corresponded to an equally diverse range of preferences for educational content, delivery and timing. Many patients reported using the web while others preferred traditional formats for information delivery. There was some interest in receiving education using mobile technology. CONCLUSIONS: Our findings validate the importance of multi-modal patient education tailored to individual preferences and experiences, which may differ according to such characteristics as gender and age. The gap in pain management information is a critical finding for healthcare providers working with patients undergoing joint replacement. Developing pain management education in different formats that addresses frequently asked questions will enhance patient engagement and, their overall experience and recovery.