Safety, Efficacy, and Cost-Effectiveness of Same-Day Discharge for Left Atrial Appendage Occlusion

Background. Percutaneous left atrial appendage occlusion (LAAO) with the Watchman device is FDA approved for stroke prevention in patients with nonvalvular atrial fibrillation who have an appropriate indication. During the COVID-19 pandemic, a same-day discharge protocol (SDDP) was employed to improve resource utilization, relieve hospital occupation, and reduce the possible risk of in-hospital virus transmission. Objectives. We sought to analyze the safety, feasibility, and cost effectiveness for SDDP in patients receiving LAAO. Methods. A prospective analysis of 142 consecutive patients, 119 treated prior to SDDP and 23 who underwent SDDP following LAAO with cardiac computed tomography angiography (CTA)-guided pre-procedural planning and intracardiac echocardiogram (ICE). Procedures were performed in a single, large academic hospital in the United States. In-hospital and 45-day procedural success, adverse events, length of procedure, and length-of-stay were evaluated. Results. Baseline patient characteristics including mean CHA₂DS₂VASc scores and mean HAS-BLED scores were similar in both groups. All procedures were successful. There was no significant difference in rates of procedural complications or in-hospital adverse events. The mean procedure time in the SDDP group was 11 minutes longer than in the conventional group (62.1 ± 5.9 vs 51.1 ± 21; P=.01). Outcomes at 45-day follow-up were similar. SDDP was associated with a reduced length of stay compared with conventional strategy and a 15% reduction in total costs. Conclusions. Same-day discharge strategy for LAAO appears safe, feasible and could become the new standard approach for LAAO. A protocol including CTA pre-procedural planning, ICE-guided deployment and conscious sedation reduces hospital occupation and lowers costs.

J INVASIVE CARDIOL 2022;34(2):E124-E131.

Key words: atrial fibrillation, computed tomography angiography (CTA), COVID-19, intracardiac echocardiogram (ICE), left atrial appendage occlusion (LAAO), structural intervention

Percutaneous left atrial appendage occlusion (LAAO) with the Watchman device (Boston Scientific) is United States Food and Drug Administration (FDA) approved for stroke prevention in patients with nonvalvular atrial fibrillation (AF) who have an appropriate rationale to seek an alternative to oral anticoagulation.^1-6 Most operators have used transesophageal echocardiography (TEE) in conjunction with general anesthesia for LAAO with overnight observation following the procedure.^7,8 While there have been prior limited series of patients reported with LAAO same-day discharge, as yet there have been no studies comparing a same-day discharge strategy for LAAO to the conventional approach.^9,10

Most operators have used TEE in conjunction with intubation and general anesthesia (GA) for LAAO, which not only poses a risk of COVID-19 exposure to patients and healthcare providers,^15,16 but also is associated with longer patient recovery and more post-procedural complications than a conscious sedation approach.^17,18 By avoiding general anesthesia, a same-day strategy using intracardiac echocardiography (ICE) and conscious sedation may be safer and translate into reduced hospital stay and expedited procedural turnaround.¹¹ During the COVID-19 pandemic,^12,13 we implemented a same-day discharge strategy to reduce possible in-hospital virus exposure and to ease bed strain by reducing length of stay.¹⁴

We sought to compare the feasibility, outcomes, and cost for same-day discharge vs conventional strategy in patients undergoing LAAO.

Patient population and study design. This is a prospective analysis of consecutive patients who underwent the Watchman procedure with a cardiac computed tomography angiography (CTA)-ICE same-day discharge strategy at University Hospitals, Cleveland Medical Center in Cleveland, Ohio from June 25th to December 31st, 2020. These patients were compared to 119 patients that had undergone a conventional strategy under general anesthesia and guided by TEE from December 15th, 2016 to June 24th, 2020. This study was approved by the University Hospitals Cleveland Medical Center Institutional Review Board. All patients referred for closure had a history of nonvalvular AF with a documented CHA₂DS₂VASc score ≥ 2 and a documented need to seek alternative to long term anticoagulation. We reviewed the final device size deployed, number of devices required, correlation of final device size to preprocedural device size estimation, length of stay, patient demographics, and periprocedural adverse events.

Preprocedural imaging. We used a standard imaging protocol developed in our center that has been described previously.^19,20 All patients underwent preprocedural cardiac CTA imaging within 30-days of their device implant, and several underwent cardiac CTA on the same day of the procedure. The Siemens Somatom Definition Flash dual source 128 slice CT scanner performed with prospective systolic triggered cardiac-gating was used for image acquisition (Figure 1). The Aquarius Workstation (TeraRecon Inc) was used for the multiplanar reconstruction (MPR) analysis of the left atrial appendage (LAA). An MPR oblique plane was defined from the level of the circumflex artery to a point 1-2 cm from the tip of the limbus.²¹ Then the initial Watchman device size was selected according to the area of the LAA landing zone  measurements. If this area indicated that two possible device sizes would provide adequate compression, the larger size was selected if there was adequate appendage depth. This LAA device depth was estimated by measuring from the LAA ostium to the end of the most usable appendage lobe. A 3D-rendering was performed to assess LAA morphology. The interatrial septum was assessed for thickness, morphology, and for the best location of transseptal approach to the LAA.

Intra-procedural imaging and device deployment. Two different platforms were used in our study; initially, the original Watchman 2.5 LAAO platform, and subsequently its new generation Watchman LAAO FLX.

Patients who underwent same day protocol LAAO underwent the procedure using conscious sedation through administration of intermittent intravenous bolus of midazolam and fentanyl. Intravenous heparin was administered to achieve an activated clotting time > 250 seconds. An 8 Fr ACUSON AcuNav ultrasound catheter (Biosense Webster) was used for ICE imaging. Assessment for pericardial effusion was performed with the AcuNav probe advanced into the right ventricle. Thrombus in the LAA was excluded by positioning the catheter in the right ventricular outflow tract. Using views from the ICE catheter in right atrium, transseptal puncture was performed using an NRG radiofrequency (Baylis Medical) transseptal needles through VersaCross transseptal sheath. The Watchman sheath was advanced across the septum and then retracted back into the right atrium, thus allowing the ICE probe to enter through the 14 Fr dilated passage. Images from the left atrium were acquired using the ICE ultrasound catheter. A 6 Fr pigtail catheter was advanced through the Watchman delivery sheath and advanced into the LAA to perform LAA angiography, most commonly in an anterior-posterior/caudal or right anterior oblique/caudal projections (Figure 2A). The cardiac CTA-determined device size was compared with LAA angiography and ICE images. The final selected device was then loaded into the delivery sheath and implanted into the LAA. A modified “PASS” (Position, Anchor, Size, Seal) criteria was applied for device release and used to define device success. Two primary ICE views were utilized from the LA: (1) mid-left atrium with view of the mitral valve, LAA, and left upper pulmonary vein (LUPV), and (2) mitral inflow with an inferior view of the LAA and LUPV (Figure 2C). Leak around the device was determined by ICE. A final LAA angiography was also utilized, and a “tug-test” was performed to confirm the stability of the device (Figure 2, Panel B). Having satisfied position, anchoring, size and seal criteria, the device was successfully deployed. All equipment was then removed, and hemostasis was facilitated by Vascade closure devices (Cardiva Medical) and manual pressure. The procedure time was defined as time from the administration of local anesthetic until the deployment of the device.

We defined bleeding based on the Valve Academic Research Consortium (VARC)-2 criteria,²² which not only includes the original definitions but also acknowledges the consensus of Bleeding Academic Research Consortium (BARC), thus further standardizing the endpoint definitions for clinical evaluation of LAAO.

Same-day discharge protocol. We developed a same-day discharge protocol shown in Figure 3. Patients treated with this protocol underwent LAAO using conscious sedation; anesthesiology support was not utilized. Patients were discharged home after 4 hours of bedrest if the criteria were satisfied. If any criteria were not satisfied, the patient was monitored overnight. First, the procedure should be uncomplicated with no bleeding issues or other technical concerns. For patients receiving the Watchman 2.5 device, no device recapture was permitted. For patients receiving the Watchman FLX device, limited (3 or less) device recaptures were permitted. Secondly, there should be good access site hemostasis, and no signs of bleeding after 4 hours of bedrest. Thirdly, post-implant transthoracic echocardiogram (TTE) should demonstrate good device position and absence of pericardial effusion or no change in effusion if present on baseline ICE images. Finally, the patient should have an overnight caregiver and transportation home.

Financial analysis. Cost analysis was performed for same-day discharge protocol and compared with analysis for patients who had previously undergone LAAO using the conventional protocol guided by TEE under general anesthesia. When using ICE, conscious sedation was administered under the operator’s supervision without the presence of anesthesia staff.  Total hospital charges and costs, and total professional fees were compared.  There were several common charges between the two groups including medical/surgical supplies during the procedure, baseline clinical laboratory, ECGs, post-implant transthoracic echocardiogram, and pharmacy. Costs unique to the same-day discharge group included CTA, ICE probe and conscious sedation charges. Costs unique to TEE group included cost of two TEEs (preprocedural and intra-procedural), general anesthesia charges, anesthesiology professional fees, chest s-ray, overnight stay at telemetry room rate, and post-implant laboratory studies (complete blood count and renal function panel).

Statistical analysis. Descriptive statistics were used to summarize the baseline and procedural characteristics. Categorical variables are presented as numbers and percentages. Continuous variables are presented as means and standard deviations (± SD).  For categorical variables, Fisher’s exact test or the chi-square test was used to compare the two groups. For continuous variables, the Wilcoxon rank-sum test and t-test were used to compare the two groups as appropriate. All tests were two-sided. A P-value <.05 was considered statistically significant. All statistical analyses were performed using SPSS 25.0 (IBM SPSS Inc.).

From December 15, 2016, we prospectively followed 119 patients undergoing LAAO with a conventional approach. When elective procedures were resumed in our center during the COVID pandemic, we initiated a SDDP. From June 25th until December 31, 2020, 37 patients underwent LAAO and 23 (62.2%) patients were discharged on the day of procedure per protocol. Most that were ineligible for same-day discharge had late afternoon procedures, making it impossible to obtain post-implant TTE. One patient had minor site bleeding after ambulation, necessitating additional manual pressure and bedrest. These 23 patients were compared to 119 patients who had previously undergone LAAO using the conventional protocol from January 2016 until May 2019.

The demographic baseline characteristics for both groups are shown in Table 1. For the same-day discharge protocol, the mean age was 74.4 ± 8.6 years, 9 (39.1%) were male, 21 (91.3%) hypertensive, and 7 (30.4%) diabetic. The mean CHA₂DS₂VASc score was 4.3 ± 1.2 and the mean HAS-BLED score was 4.0 ± 0.9. Almost half of the patients had paroxysmal AF (12, 52.2%) and the other half had persistent or permanent AF (11, 47.8%). There were no statistically significant differences between the 2 groups.

The procedural characteristics for both groups are described in Table 2. For the same-day discharge protocol, all patients had a successful ICE-guided implant (23, 100%), and the majority of the deployments (22, 95.7%) were sized based on the preprocedural CTA. There were no device embolizations.  All patients in the same-day protocol were treated under conscious sedation; none required general anesthesia or monitored anesthesia care. No patient needed intubation, mechanical ventilation, conversion to general anesthesia, or cardiac surgery. No adverse events or complications such as pericardial effusion or bleeding occurred in this group. All implants were performed using the Watchman devices, 8 (34.8%) with the 2.5 platform and 15 (65.2%) using the FLX platform. The majority of patients were treated using sizes 27 mm (8, 34.8%) or 31 mm (5, 21.7%). The procedural time that was higher in the same-day discharge protocol compared to the conventional protocol (62.1 ± 5.9 min vs 51.1 ± 21 min, respectively; P=.01). There was no significant difference in rates of procedural complications or in-hospital adverse events. Outcomes at 45-day follow-up were similar.

Finally, we performed a comparison of costs involved in a LAAO protocol with same-day discharge versus the conventional protocol with general anesthesia and overnight stay (Table 3). While we are unable to provide financial data specific to our institution, we can describe the major factor determinants taken into account. Based on these costs, we calculated the net difference between the strategies. LAAO with a same-day discharge was associated with a 15% reduction in overall cost per patient as compared with LAAO utilizing procedural time a conventional approach with GA and overnight stay.

As far as we know, this is the first prospective study comparing the safety, feasibility, and cost-effectiveness of the same-day discharge strategy with a conventional approach.^9,23-26 Our study demonstrates that the majority of patients can safely be discharged from LAAO on the same day of their procedure and with lower overall cost.

During the early phase of the COVID-19 crisis, many healthcare institutions did not allow elective procedures that required overnight stay due to resource re-allocation and bed availability. A same-day discharge protocol for LAAO reduces hospital occupation and therefore the procedure does not affect inpatient bed capacity. Since there is no need for keeping the patient in the intensive care unit or on telemetry, these facilities may be redirected to other patients in need. Implementation of this protocol may be particularly advantageous in hospitals with reduced ICU or telemetry bed availability. Secondly, we observed a 15% cost-reduction in the same-day discharge group compared to the conventional approach with overnight stay.

An important advantage of an ICE-guided strategy is the avoidance of GA which may reduce the risk of infection,²⁸ allow earlier discharge,¹⁰ and expedite the procedure turnaround.¹¹ The use of GA requires anesthesiology support and is associated with longer patient recovery and GA is associated with more post-procedural complications than conscious sedation.^17,18 Even when applying TEE using “moderate” conscious sedation for LAAO, as previously described by Marmagkiolis et al,⁹ the anesthesiology team must be involved which, in our experience, has impacted procedural efficiency. Furthermore, and importantly, as an aerosol-generating procedure, TEE may pose a risk of COVID-19 exposure to patients and healthcare personnel, and therefore should be deferred whenever possible.^15,28 Additionally, in a recent trial,²⁹ 86% of patients undergoing structural heart interventions guided by TEE had some form of esophageal or gastric injuries, and 40% had complex lesions such as intramural hematoma and mucosal laceration. Though intravascular, ICE may in fact pose less risk to the patient.

While same-day discharge is commonly done for percutaneous coronary intervention, patent foramen ovale closure and catheter ablation procedures, most centers monitor patients overnight following LAAO.^30,31 Studies examining same-day discharge for LAAO have been limited.²⁶ Our study examines a series of consecutive real-world patients. Our same-day discharge protocol was applied to all patients undergoing LAAO. No specific patient selection was involved. After we implemented our same-day discharge strategy, 62.2% of eligible patients were successfully discharged home on the same day as Watchman. In our experience, most of the patients that stayed overnight did so due to logistical issues, although the need for additional monitoring to address medical concerns remains possible. We anticipate that over time and with improved logistics and streamlining of our protocol, even more of our patients will be discharged same-day from LAAO. In addition to improving resources and reducing cost, we would expect a same-day discharge strategy would also improve patient satisfaction.

Although device recapture (either partial or full) may be required to achieve optimal device placement, recapture of the Watchman 2.5 device has been associated with appendage perforation.^33,34 Therefore, patients were ineligible for same-day discharge per our protocol if they had partial or full recapture using the 2.5 device. With its enclosed foot-struts, the next generation Watchman FLX device is considered much less traumatic to the appendage and therefore less problematic, and no cases of pericardial effusion were reported in the PINNACLE FLX trial.³⁶ Because of this and after the availability of the FLX device, we allowed for limited (up to 3) partial/full recaptures for the patient to have same-day discharge. We opted for a conservative approach in our protocol and some operators may feel comfortable discharging patients on the day of procedure even if more recaptures are performed with the FLX device. Given that late pericardial effusion has been described after device recapture,³⁵ we urge that patients be followed cautiously after multiple recaptures during LAAO even with the new platform.

We observed high procedural success rates in both the same-day discharge and conventional strategy groups and changing to a same-day discharge strategy did not increase rates of adverse clinical events at 45-day follow up. These findings are consistent with the literature and reassuring for both safety and efficacy of our new approach.^2,3,7-9,20 The longer procedural times noted in the same-day discharge group may be due to the learning curve in using ICE for LAAO. However, considering the improvement in efficiency and room turnaround associated with conscious sedation over GA, these 11 minutes do not seem clinically relevant. In addition, given the large standard deviation for procedural times in the conventional group, this observed time difference may not be accurate.

Study limitations. Our study should be interpreted in the light of some limitations. This is a small series of consecutive cases from a high-volume LAAO institution, and all cases were performed by a single experienced interventionalist. A larger study is warranted to help affirm our findings. Finally, limited information on peri-device leak or device-related thrombosis, was available at the time of this writing.

Same-day discharge strategy for LAAO appears safe, feasible and could become the new standard approach for LAAO. A protocol including CTA preprocedural planning, ICE-guided deployment, and conscious sedation reduces hospital occupation and lowers costs.

Acknowledgements. The authors are grateful to all nurses, technicians, and valve clinic coordinators who care for our patients, in particular Nicole Ritter and Stephen Stoycos for their assistance with images used in this manuscript.

From the ¹Division of Cardiology, Harrington Heart & Vascular Institute, University Hospitals Cleveland Medical Center, Cleveland, Ohio and ²Tampa General Hospital, University of South Florida, Tampa, Florida.

Disclosure: The authors have completed and returned the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Bezerra reports consulting for the Speaker’s Bureau for Abbott Vascular. Dr Attizani reports consulting for the Advisory Board for Medtronic. Dr Filby reports consultant/advisory board fees from Boston Scientific. Dr Simon reports consulting honoraria from Medtronic. Dr Shishehbor reports serving on the global advisory board and consulting for Abbott Vascular, Medtronic, Boston Scientific, Terumo, and Philips. The remaining authors report no conflicts of interest regarding the content herein.

Manuscript accepted May 5, 2021.

The authors report patient consent for the images used herein.

Address for correspondence: Steven J. Filby, MD, University Hospitals, Cleveland Medical Center, 11100 Euclid Avenue, Lakeside 3rd floor, Cleveland, OH, 44106. Email: Steven.Filby@UHhospitals.org

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