What is the clinical evidence from this study?

Study design: Observational. Population: Atrial fibrillation (n=521). Intervention: Conscious sedation vs. General anesthesia. Primary outcome: Composite of major periprocedural complications and postoperative pneumonia (p=0.18).

What question did this study set out to answer?

To determine the impact of conscious sedation compared with general anesthesia on acute procedural safety and success in patients undergoing left atrial appendage closure with a Watchman device.

January 13, 2021Cardiology JournalOpen Access

Impact of conscious sedation and general anesthesia on periprocedural outcomes in Watchman left atrial appendage closure

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Key result

Conscious sedation for left atrial appendage closure with the Watchman device resulted in comparable safety outcomes (3.5% vs. 7.0%, p=0.18) and device success (96.9% vs. 93.9%, p=0.24) compared to general anesthesia.

Why the study?

Transcatheter left atrial appendage closure is performed using conscious sedation or general anesthesia, but limited data exist regarding clinical outcomes between the two approaches.

Does conscious sedation compared to general anesthesia maintain safety and efficacy in patients undergoing left atrial appendage closure with a Watchman device?

Key Points

To determine the impact of conscious sedation compared with general anesthesia on acute procedural safety and success in patients undergoing left atrial appendage closure with a Watchman device.
Conducted a retrospective two-center study in Germany evaluating 521 consecutive patients who received a Watchman occluder under either general anesthesia (N=303) or conscious sedation (N=218) between 2012 and 2018.
Used 1:1 propensity score matching to balance cohorts, evaluating a primary safety endpoint (composite of major complications and postoperative pneumonia) and an efficacy endpoint (device success).
Following propensity matching (196 conscious sedation vs. 115 general anesthesia), the composite safety endpoint occurred in 3.5% vs. 7.0% of patients (p = 0.18), with 2.6% requiring conversion from sedation to general anesthesia.
Individual safety components showed no significant differences for major periprocedural complications (2.5% vs. 3.5%, p = 0.73) or postoperative pneumonia (2.6% vs. 4.3%, p = 0.51).
Device success rates were 96.9% in the conscious sedation group and 93.9% in the general anesthesia group (p = 0.24).

Study Design

Type

Observational (n=521)

Multicenter

Yes

Structured PICO

Does conscious sedation compared to general anesthesia maintain safety and efficacy in patients undergoing left atrial appendage closure with a Watchman device?

Population

311 propensity-matched patients with atrial fibrillation undergoing left atrial appendage closure with a Watchman device, evaluated for periprocedural and 30-day outcomes.

Exposure

Conscious sedation (CS) using a 1-5 mg bolus of midazolam and continuous propofol at the lowest dose possible, with local anesthesia (mepivacaine 1% at puncture site and lidocaine pump spray for TEE probe), guided by transesophageal echocardiography (TEE) and fluoroscopy.

Comparator

General anesthesia (GA) with orotracheal intubation and mechanical ventilation, using a combination of propofol and an opioid (fentanyl or remifentanil), guided by TEE and fluoroscopy.

Outcome

Composite safety endpoint of major periprocedural complications (death <72 hours, stroke, device embolization, cardiac tamponade or pericardial effusion requiring intervention, major bleeding >BARC type 3a, need for bailout surgery, need for CPR, severe kidney injury, and other relevant complications leading to prolonged hospital stay) and postoperative pneumonia.composite

Main Result

Absolute Event Rate: 3.5% vs 7%

p-value: p=0.18

Limitations

Retrospective, non-randomized, and observational design
Different procedural settings of the general anesthesia and conscious sedation groups
Relatively small sample size, not powered to detect differences in procedural and clinical outcomes
Potential unmeasured confounders despite propensity score matching
Patient enrollment started 4 years earlier at the general anesthesia site, capturing the learning curve
Incomplete transesophageal echocardiography follow-up in the conscious sedation group
Different procedural settings between the general anesthesia and conscious sedation groups
Confounders may persist despite propensity score matching (e.g., differences in gender, hypertension, permanent AF, liver disease)
Learning curve bias (GA site started 4 years earlier, impacting intervention times and contrast volume)
Incomplete TEE follow-up in the CS group, potentially leading to underreporting of device-related thrombus and peri-device leaks

Implication

Conscious sedation may be feasible for Watchman implantation; leaves open confirmation of noninferiority in randomized trials.

Abstract

BACKGROUND: Transcatheter left atrial appendage closure (LAAC) is performed either in conscious sedation (CS) or general anesthesia (GA), and limited data exist regarding clinical outcomes for the two approaches. The aim of the study was to analyze the effect of CS versus GA on acute outcomes in a large patient cohort undergoing LAAC with a Watchman occluder. METHODS: A cohort of 521 consecutive patients underwent LAAC with Watchman occluders at two centers (REGIOMED hospitals, Germany) between 2012 and 2018. One site performed 303 consecutive LAAC procedures in GA, and the other site performed 218 consecutive procedures in CS. The safety endpoint was a composite of major periprocedural complications and postoperative pneumonia. The efficacy endpoint was defined as device success. RESULTS: After a 1:1 propensity score matching, 196 (CS) vs. 115 (GA) patients could be compared. In 5 (2.6%) cases CS was converted to GA. The primary safety endpoint (3.5% [CS] vs. 7.0% [GA], p = 0.18) and its components (major periprocedural complications: 2.5% vs. 3.5%, p = 0.73; postoperative pneumonia: 2.6% vs. 4.3%, p = 0.51) did not differ between the groups. Also, device success was comparable (96.9% vs. 93.9%, p = 0.24). CONCLUSIONS: In patients undergoing LAAC with the Watchman device, conscious sedation and general anesthesia showed comparable device success rates and safety outcomes. The type of anesthesia for LAAC may therefore be tailored to patient comorbidities, operator experience, and hospital logistics.

Discussion

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Published by Cardiology Journal · CC BY-NC-ND

Cite This Study

Kleinecke et al. (2021) conducted an observational in Atrial fibrillation (n=521). Conscious sedation vs. General anesthesia was evaluated on Composite of major periprocedural complications and postoperative pneumonia (p=0.18). Conscious sedation for left atrial appendage closure with the Watchman device resulted in comparable safety outcomes (3.5% vs. 7.0%, p=0.18) and device success (96.9% vs. 93.9%, p=0.24) compared to general anesthesia.

synapsesocial.com/papers/6a98194eb677aa8bf5c60dbf https://doi.org/10.5603/cj.a2020.0184

Topics

Left atrial appendage closure

Atrial fibrillation

Persistent AF management

AF ablation outcomes

Anticoagulation in AF

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Implication

Conscious sedation may be feasible for Watchman implantation; leaves open confirmation of noninferiority in randomized trials.

Impact of conscious sedation and general anesthesia on periprocedural outcomes in Watchman left atrial appendage closure

Key Points

Study Design

Structured PICO

Main Result

Limitations

Implication

Abstract

Discussion

Figures from the paper

Cite This Study

Topics

Impact of conscious sedation and general anesthesia on periprocedural outcomes in Watchman left atrial appendage closure

Key Points

Study Design

Structured PICO

Main Result

Limitations

Implication

Abstract

Discussion

Figures from the paper

Cite This Study

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