key: cord-0014944-os3iecb5
authors: Tan, Bryan E-Xin; Boppana, Leela Krishna Teja; Abdullah, Abdullah S.; Chuprun, Dmitry; Shah, Abrar; Rao, Mohan; Bhatt, Deepak L.; Depta, Jeremiah P.
title: Safety and Feasibility of Same-Day Discharge After Left Atrial Appendage Closure With the WATCHMAN Device
date: 2021-01-11
journal: Circ Cardiovasc Interv
DOI: 10.1161/circinterventions.120.009669
sha: 7114523b225d9fedade931b71d0b39fcfd6c9fc4
doc_id: 14944
cord_uid: os3iecb5

BACKGROUND: As the use of left atrial appendage closure (LAAC) becomes more widespread, improvements in resource utilization and cost-effectiveness are necessary. Currently, there are limited data on same-day discharge (SDD) after LAAC. We aimed to evaluate the safety and feasibility of SDD versus non-SDD in patients with nonvalvular atrial fibrillation who underwent LAAC. METHODS: We retrospectively studied 211 patients who underwent the WATCHMAN procedure in a tertiary hospital (June 2016 to June 2019). The primary safety outcome was the composite of stroke, systemic embolism, major bleeding requiring transfusion, vascular complications requiring endovascular intervention, or death through 7 days (periprocedural) and 45 days post-procedure. The secondary outcomes were the individual components of the primary outcome and all-cause readmission. We compared the clinical outcomes of patients who had SDD and non-SDD post-procedure. RESULTS: Patients with procedure-related complications on the day of LAAC and patients who were admitted for acute clinical events before LAAC were excluded. One hundred ninety patients were included in the final analysis. Seventy-two of 190 (38%) patients had SDD, and 118 of 190 (62%) had non-SDD. There were no statistically significant differences in the primary safety outcome through 7 days (1.4% versus 5.9%; P=0.26) and 45 days post-procedure (2.8% versus 9.3%; P=0.14) between the two groups. The secondary outcomes were similar in both groups. No patients had device-related thrombus on transesophageal echocardiography at 45 days. Only 1 patient from the non-SDD group had clinically significant peri-device flow (>5 mm) at 45 days. CONCLUSIONS: In a selected cohort of patients who underwent successful elective LAAC with WATCHMAN without same-day procedure-related complications, the primary safety outcome and secondary outcomes through 7 and 45 days post-procedure were similar in the SDD and non-SDD groups. Our findings are hypothesis generating and warrant further investigation in prospective trials.

A trial fibrillation (AF) has a prevalence of 1% to 2% in the adult population. 1 The majority of AF patients receive oral anticoagulation (OAC) to reduce the risk of stroke. Previous studies showed that ≈13% of AF patients have a contraindication to OAC, 2 and 2% have an absolute contraindication, most frequently due to a history of intracranial hemorrhage. 3 Percutaneous left atrial appendage (LAA) closure (LAAC) has emerged as a feasible option for stroke prevention in patients with nonvalvular AF. 4 The rate of procedure-related complications with the WATCHMAN device at 7 days was 8.7% and 4.2% in the PROTECT-AF (WATCHMAN Left Atrial Appendage System for Embolic Protection in Patients With Atrial Fibrillation) and PREVAIL (Evaluation of the WATCHMAN LAA Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy) trials, respectively. 5, 6 However, the more recent EWOLUTION study (Evaluating Real-World Clinical Outcomes in Atrial Fibrillation Patients Receiving the WATCHMAN Left Atrial Appendage Closure Technology) has shown a considerably lower 7-day procedure-related complication rate (2.7%). 7 The complication rate is not negligible but improves with higher annual hospital volume and operator experience. 8 The current real-world in-hospital adverse event rate is low (2.2%), as reported in the National Cardiovascular Data Registry LAA Occlusion Registry. 9 In contemporary practice, patients are hospitalized overnight after LAAC and typically discharged the following day. 10 Currently, there are limited data on same-day discharge (SDD) for LAAC. 11, 12 SDD following LAAC has the potential to reduce hospital costs and improve patient satisfaction.

In this retrospective analysis of a single center, we report the safety and outcomes of SDD compared with non-SDD following WATCHMAN implantation.

The data that support the findings of this study may be made available from the corresponding author upon reasonable request.

This was a retrospective study of patients who underwent LAAC with WATCHMAN in a tertiary hospital (United States) between June 2016 and June 2019. 13 Institutional review board approval was obtained. Institutional review board waived patient informed consent for this study. The following patients were excluded from the analysis for the primary safety and secondary outcomes: (1) patients with unsuccessful procedures, (2) patients with same-day procedure-related complications (ie, occurring on the day of LAAC), and (3) patients admitted for acute clinical events before LAAC.

Three experienced operators (J.P.D., D.C., and A.S.) performed LAAC in our center. All procedures were performed under general anesthesia with transesophageal echocardiography (TEE) and fluoroscopy guidance. All patients were fully anticoagulated with heparin to maintain an activated clotting time >250 s. A single Perclose was performed on all patients postprocedure to achieve hemostasis.

Post-procedure, all patients were extubated in the catheterization laboratory and recovered in the procedural recovery area. They were ambulated 2 hours post-procedure to assess the integrity of the vascular access site. Depending on the patient's and family's preference, patients were discharged within 3 to 4 hours post-procedure (ie, SDD) or the following day (non-SDD). SDD patients were discharged directly from the procedural recovery area, while non-SDD patients were admitted to and discharged from a cardiac floor ( Figure 1 ). OAC was started the evening of the procedure on all patients without a bleeding event. The use of predischarge transthoracic echocardiography (TTE) was at the discretion of the operator. Patients were typically maintained on aspirin and OAC (warfarin or direct OAC) for 45 days following successful LAAC.

We assessed 7-day procedure/device-related complications in all patients, including those excluded in the analysis of the primary safety outcome and secondary outcomes. Using identical definitions from previous trials, 7-day procedure/device-related complications were defined as a composite of periprocedural stroke, systemic embolism, pericardial tamponade, cardiac perforation, device embolization, serious vascular complications, or death through 7 days post-LAAC. 6 

• In a selected cohort of patients who underwent elective left atrial appendage closure with the WATCHMAN device without same-day procedurerelated complications, same-day discharge appears to be safe. • Same-day discharge reduces length of stay, thereby improving resource utilization and overall costs to the health care system. • Our findings are considered hypothesis generating and warrant further investigation in prospective trials.

The primary safety outcome was a composite of stroke, systemic embolism, major bleeding requiring transfusion, vascular complications requiring endovascular intervention, or death through 7 (periprocedural) and 45 days. The secondary outcomes were the individual components of the primary safety outcome and all-cause readmission. Peridevice flow and device-related thrombus were assessed on 45-day TEE.

Categorical variables were presented as counts and percentages. Continuous variables were presented as mean±SD.

Pearson χ 2 test was performed to compare categorical variables between SDD and non-SDD groups; if any cells in a 2×2 Device deployment was not attempted in 3 patients (2 had difficult vascular access and 1 had unsuitable LAA anatomy; Figure 2 ). Among procedures in which a device was deployed, 96.2% (200 of 208) were successfully implanted. We excluded 8 aborted procedures, which included 6 patients who did not meet the PASS device release criteria, 1 LAA perforation requiring emergent surgical repair, and 1 death due to hemothorax and suspected cardiac perforation of the left atrium ( Figure 2 ). Of the 200 patients with a device successfully deployed, 4 patients were excluded for procedure-related complications that occurred on the same day of the procedure ( Figure 2) , where 1 patient developed a pericardial effusion during the procedure requiring percutaneous drainage and 3 patients developed hypotension in the first 2 hours after the procedure secondary to pericardial effusion requiring either percutaneous drainage (n=2) or open surgical drainage (n=1). Of the 196 patients with a successful procedure without complication, we excluded 6 patients admitted to the hospital for acute clinical events before nonelective LAAC (3 gastrointestinal bleeds and 3 mechanical falls). The final analysis of the primary safety and secondary outcomes included 190 patients ( Figure 2 ). The 7-day procedure/device-related complication rate was 4.3% (9 of 211). In addition to the 6 patients who had same-day events (4 pericardial effusion requiring drainage, 1 LAA perforation, and 1 death as stated in the previous paragraph), 1 patient had an event the day following the procedure before discharge (significant groin hematoma requiring transfusion and epinephrine injection), and 2 patients had events after discharge through 7 days post-procedure (1 ischemic stroke and 1 femoral pseudoaneurysm requiring endovascular surgery).

All the patients in the final analysis (n=190) had complete follow-up during the 45-day period post-procedure. All patients were ambulated 2 hours after the procedure, and none had immediate issues with vascular access site. Age, sex, CHA 2 DS 2 -VASc score, and comorbidities were similar between the two groups, but the mean HAS-BLED score (hypertension, abnormal renal/liver function, stroke, bleeding history or predisposition, labile international normalized ratio, elderly, drugs/alcohol concomitantly) in the SDD group was lower than the non-SDD group (2.7 versus 3.0; P=0.04; Table 1 ). A history (Table 2) were similar except for a shorter mean procedural time in the SDD group compared with the non-SDD group (68.8 versus 79.6 minutes; P=0.02).

One patient from the non-SDD group had persistent LAA thrombus despite OAC and underwent successful, uncomplicated LAAC with off-label use of transcatheter cerebral embolic protection. 14 TTE was performed in 31.6% (60 of 190) of patients before discharge. Patients were discharged more frequently on direct OACs (77.4%) as opposed to warfarin (22.1%). Of the patients discharged on OAC (n=189), antiplatelet therapy was also prescribed in 90.5% of patients (171 of 189) and included aspirin (168 of 171) and clopidogrel (3 of 171).

Length of stay ranged from 0 (SDD) to 4 days, where 38% of patients had SDD, 58% were discharged the following day post-procedure, and 4% had an extended length of stay ≥2 days. Two-day length of stay occurred in 2 patients (1 rapid AF and 1 patient preference). Three-day length of stay occurred in 4 patients: 2 had vascular access complications (1 significant groin hematoma requiring epinephrine injection and transfusion and 1 groin hematoma managed conservatively), 1 had digoxin toxicity, and 1 was related to social issues. Four-day length of stay occurred in 1 patient (right adductor hematoma requiring transfusion).

At 7 days post-procedure, the primary safety outcome was similar in the SDD compared with non-SDD groups (1.4% versus 5.9%; P=0.26; Table 3 ). There were no significant differences in the individual components of the primary safety outcome and all-cause readmission.

At 45 days, there were no statistically significant differences in primary safety outcome between the two groups (SDD, 2.8% versus non-SDD, 9.3%; P=0.14; Table 3 ). Major bleeding requiring transfusion occurred in 2.8% (2 of 72) of SDD patients and 7.6% (9 of 118) of non-SDD patients (P=0.21). These include the following: SDD group: 2 gastrointestinal bleeds; non-SDD group: 7 gastrointestinal bleeds, 1 right adductor hematoma (during hospital stay), and 1 groin hematoma (during hospital stay).

At 45 days, ischemic stroke occurred in 0% (0 of 72) of SDD patients and 0.8% (1 of 118) of non-SDD patients (P=1.0). One patient had an ischemic stroke on OAC through 7 days post-procedure (found to have 

This study demonstrates the potential safety and feasibility of SDD in patients undergoing elective LAAC with the WATCHMAN device in a real-world clinical setting.

The mean age of our population is higher than the pivotal trials 5,6 and the EWOLUTION trial 7 and is similar to the National Cardiovascular Data Registry LAA Occlusion registry. 9 Our mean CHA 2 DS 2 -VASc score of 4.8 indicates a higher stroke risk compared with the PRO-TECT-AF (CHA 2 DS 2 -VASc of 3.4), PREVAIL (CHA 2 DS 2 -VASc of 4.0), and EWOLUTION (CHA 2 DS 2 -VASc of 4.5) trials. [5] [6] [7] In our study, 62% of patients had a HAS-BLED score ≥3, compared with 20% in PROTECT-AF, 30% in PREVAIL, and 40% in EWOLUTION. [5] [6] [7] Additionally, 81.1% of patients had a history of bleeding requiring hospitalization or transfusion compared with 38.7% in the EWOLUTION trial. 7 It is worth noting that 53% of our study population was not on OAC at the time of LAAC referral, likely due to an elevated risk for or history of bleeding. The National Cardiovascular Data Registry LAA Occlusion registry is the largest analysis of LAAC (>38 000 patients enrolled from January 2016 to December 2018) in the post-FDA-approval era of WATCHMAN. 9 The mean CHA 2 DS 2 -VASc and HAS-BLED score was 4.6 and 3.0, respectively, and 69.4% of subjects in this registry had a clinically relevant bleeding history. 9 Similar to the National Cardiovascular Data Registry LAA Occlusion Registry, our study comprised an older and sicker patient population with a higher risk of stroke and bleeding compared with previous trials. [5] [6] [7] Thus, our study findings should be applicable to patients currently undergoing LAAC in the United States.

Our implantation success rate (96.2%) is comparable to previous studies ( Figure 4) . [5] [6] [7] 9, 15 Our 7-day procedure/device-related complication rate was 4.3%, lower than PROTECT-AF (8.7%) 5 and compared favorably to the subsequent WATCHMAN studies. 6, 7, 15 (Figure 5 ). In our study, 38% of patients had SDD and 62% had non-SDD. The trend of SDD, comparing the first year and final year of the study, increased significantly from 0% to 53.3%, reflecting our center/operator experience in postprocedural care and improved comfort level for SDD.

A retrospective single-center study (United Kingdom) reported SDD in 66% of patients after LAAC with acceptable in-hospital adverse event rates. 11 In that study, 50.4% of patients had LAAC with the Amplatzer Cardiac Plug, 41% with the Amulet Occluder, and 2.5% with WATCHMAN. 11 That study did not report the clinical outcomes during follow-up post-discharge. Moreover, the patients in that study were discharged on dual antiplatelet therapy for 4 weeks and a single antiplatelet thereafter for at least 6 months, 11 which is consistent with the current European recommendations for patients not suitable for OAC. 16 In North America, patients are typically maintained on OAC and aspirin for 45 days and transitioned to dual antiplatelet therapy for 6 months if the 45-day TEE shows an absence of peri-device flow >5 mm or device-related thrombus. This practice is consistent with the study protocol of previous trials, where warfarin was used exclusively. 5, 6 Direct OACs may be a preferable alternative to warfarin for short-term anticoagulation. 17 In our study, 77% of patients were discharged on a direct OAC post-procedure.

Evaluating the primary safety outcome and secondary outcomes during the periprocedural period is important as patients are prone to clinical events within the first 7 days post-procedure. 7 In EWOLUTION, the adverse event rate was 7.9% at 30 days, with close to half of the events (4.1%) occurring by 7 days postprocedure. 7 In our study, 53% of patients were not on OAC at LAAC referral and started OAC postprocedurally, which has the potential to increase bleeding risk. Although the differences were not statistically significant, more patients from the non-SDD group experienced the primary safety outcome, which was mainly driven by major bleeding requiring transfusion both during the periprocedural period and at 45 days. This was likely related to the higher mean HAS-BLED score in the non-SDD group (2.7 versus 3.0; P=0.04). The average length of stay for LAAC was 4.6 days in the pre-FDA approval era of WATCHMAN. 8 Currently, standard practice post-procedure typically involves monitoring patients overnight and discharging the following day. 10 According to a recent study utilizing the National Inpatient Sample database, the median length of stay is 1 day. 10 At present, SDD has been used for other cardiac procedures, including elective percutaneous coronary intervention, 18 radiofrequency catheter ablation, 19 and patent foramen ovale closure without increased risk of complications compared with overnight monitoring. 20 With increasing experience, elective LAAC should be included among these procedures. SDD in uncomplicated elective LAAC can reduce the length of stay, thereby improving resource utilization and reducing overall health care costs. The average cost savings have been estimated at $2500 per patient, 21 which should translate into better use of hospital resources. Furthermore, SDD may improve patient satisfaction, as shown in previous literature on elective percutaneous coronary intervention. 22 

The main limitation of this study is its observational nature with several inherent limitations, including risk for selection bias, confounding bias, and the inability to attribute causation. However, the inherent selection bias associated with SDD patients reinforces that the operator and patient/family are appropriately selecting those who may be suitable for SDD.

Second, the small sample size may lead to the study being underpowered to detect a statistically significant difference in clinical outcomes. However, the complication rates with the WATCHMAN procedure were relatively low in recent studies, likely due to increased hospital and operator experience. [6] [7] [8] As such, a study powered to detect a statistically significant difference in clinical outcomes between the SDD and non-SDD groups would require a much larger sample size.

Finally, routine predischarge TTE was not part of the institutional protocol unless the patient developed symptoms/hypotension. Predischarge TTE was at the discretion of the operators. Variability in its use may not capture all periprocedural device-related complications (eg, pericardial effusion). However, in our study, only 2 patients were readmitted through 7 days postprocedure (1 femoral pseudoaneurysm and 1 periprocedural stroke); none could have been prevented with a predischarge TTE. In the EWOLUTION trial, of 1019 patients who underwent LAAC, 0.4% (5 of 1019) had procedure-related pericardial effusion (including 1 cardiac tamponade) within 24 hours of LAAC. 7 The risk of late pericardial effusion within 24 hours of LAAC cannot be adequately assessed by intraprocedural TEE. Thus, routine predischarge TTE for all patients may be warranted in future trials and clinical practice, especially for patients considered for SDD.

In a selected cohort of patients who underwent successful elective LAAC with the WATCHMAN device without same-day procedure-related complications, the primary safety outcome and secondary outcomes were similar in patients with SDD compared with non-SDD. At 7 and 45 days post-procedure, there were no statistically significant differences in stroke, systemic embolism, major bleeding requiring transfusion, vascular complications requiring endovascular intervention, death, all-cause readmission, and significant peri-device flow or devicerelated thrombus on 45-day TEE between the two groups. SDD has the potential to minimize the unnecessary use of medical resources and improve patient satisfaction without compromising patient safety. Due to the retrospective nature of this study, our findings are considered hypothesis generating. Prospective trials with postprocedural randomization of SDD and non-SDD are warranted to confirm the findings of our study.

Received June 8, 2020; accepted September 16, 2020. 

Medscape Cardiology, PhaseBio, PLx Pharma, and Regado Biosciences; belongs to the Board of Directors at the Boston VA Research Institute, Society of Cardiovascular Patient Care, and TobeSoft; is a chair at the American Heart Association Quality Oversight Committee; belongs to the Data Monitoring Committees at the Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute, for the PORTICO trial [Portico Re-Sheathable Transcatheter Aortic Valve System US IDE Trial], funded by St. Jude Medical, now Abbott), Cleveland Clinic (including for the ExCEED trial [A Prospective, Single-Arm, Controlled, Multicenter Study to Establish the Safety and Effectiveness of the CENTERA THV System in Intermediate Risk Patients Who Have Symptomatic, Severe, Calcific, Aortic Stenosis Requiring Aortic Valve Replacement

Chief Medical Editor, Cardiology Today's Intervention), Society of Cardiovascular Patient Care (Secretary/Treasurer), and WebMD (CME Steering Committees); other from Clinical Cardiology (Deputy Editor), NCDR-ACTION Registry Steering Committee (chair), and VA CART Research and Publications Committee (chair); research funding from Abbott

Burden of atrial fibrillation-associated ischemic stroke in the United States

Physician practices regarding contraindications to oral anticoagulation in atrial fibrillation: findings from the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF) registry

Contraindications to anticoagulation therapy and eligibility for novel anticoagulants in older patients with atrial fibrillation. Cardiovasc Ther

AHA/ACC/HRS Focused update of the 2014 AHA/ACC/HRS Guideline for the management of patients with atrial fibrillation: a report of the American College of Cardiology/American Heart Association Task Force on clinical practice guidelines and the heart rhythm society in collaboration with the society of thoracic surgeons

Sick P; PROTECT AF Investigators. Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke

in patients with atrial fibrillation: a randomised non-inferiority trial

Prospective randomized evaluation of the WATCHMAN left atrial appendage closure device in patients with atrial fibrillation versus long-term warfarin therapy: the PREVAIL trial

EWOLUTION Investigators. Implant success and safety of left atrial appendage closure with the WATCHMAN device: peri-procedural outcomes from the EWOLUTION registry

Utilization and adverse outcomes of percutaneous left atrial appendage closure for stroke prevention in atrial fibrillation in the United States: influence of hospital volume

The NCDR left atrial appendage occlusion registry

Incidence and causes of in-hospital outcomes and 30-day readmissions after percutaneous left atrial appendage closure: a US nationwide retrospective cohort study using claims data

Day-case percutaneous left atrial appendage occlusionsafety and efficacy

Amplatzer left atrial appendage occlusion: single center 10-year experience

Necessity of 45-Day transesophageal echocardiography after the WATCHMAN procedure amid the COVID-19 pandemic

Transcatheter cerebral embolic protection during WATCH-MAN procedure in two patients with persistent left atrial appendage thrombus: case report with review of the literature

Safety of percutaneous left atrial appendage closure: results from the WATCHMAN left atrial appendage system for embolic Protection in Patients With AF (PROTECT AF) clinical trial and the continued access registry

EHRA/EAPCI expert consensus statement on catheter-based left atrial appendage occlusion -an update

Use of non-warfarin oral anticoagulants instead of warfarin during left atrial appendage closure with the Watchman device

Same-day discharge after percutaneous coronary intervention: current perspectives and strategies for implementation

Feasibility and safety of sameday home discharge after radiofrequency catheter ablation

Safety and feasibility of day case patent foramen ovale (PFO) closure facilitated by intracardiac echocardiography

Hospital Adjusted Expenses per Inpatient Day

Outpatient PTCA with same day discharge is safe and produces high patient satisfaction level

Drs Depta and Tan conceived and designed the study; Dr Tan performed the statistical analyses; Drs Tan, Boppana, and Depta wrote the manuscript; and all authors acquired, analyzed, or interpreted the data and critically revised the manuscript.