Concomitant Left Atrial Appendage Occlusion and Transcatheter Aortic Valve Replacement Among Patients With Atrial Fibrillation - WATCH TAVR

Oct 24, 2023
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Author/Summarized by Author:
Amit Saha, MD
Summary Reviewer:
Dharam J. Kumbhani, MD, SM, FACC
Trial Sponsor:
Boston Scientific
Date Presented:
10/24/2023
Date Published:
10/24/2023
Date Updated:
10/24/2023
Original Posted Date:
10/24/2023
References

Contribution To Literature:

The WATCH-TAVR trial showed that in patients with severe AS and concomitant AF, WATCHMAN implantation during TAVR was noninferior to medical therapy with anticoagulation with respect to the primary composite outcome of all-cause mortality, stroke, and major bleeding at 2 years.

Description:

The goal of the trial was to determine whether, in patients with severe aortic stenosis (AS) and comorbid atrial fibrillation (AF), transcatheter aortic valve replacement (TAVR) with simultaneous left atrial appendage occlusion (LAAO) device implantation is noninferior to TAVR with systemic anticoagulation for AF.

Study Design

  • Multicenter
  • Randomized
  • Open-label

Patients with severe AS with documented AF were randomized to undergo TAVR+LAAO implantation (n = 177) or TAVR+medical therapy alone (n = 172). In the TAVR+LAAO group, a WATCHMAN 2.5 device was implanted at the time of TAVR via transseptal puncture. The TAVR+LAAO group was treated with warfarin and aspirin for 6 weeks postoperatively followed by 6 months of dual antiplatelet therapy (DAPT). Choice of anticoagulation (warfarin or direct oral anticoagulant [DOAC]) in the TAVR+medical therapy group was at the treating physician’s discretion.

  • Total number of enrollees: 349
  • Duration of follow-up: 24 months
  • Mean patient age: 81 years
  • Percentage female: 39%

Inclusion criteria:

  • Age ≥18 years
  • TAVR planned for severe AS
  • Documented paroxysmal, persistent, or permanent AF

Exclusion criteria:

  • Transient ischemic attack (TIA) or stroke ≤6 months prior
  • Contraindication to short-term anticoagulation
  • Mitral stenosis (mean gradient >10 mm Hg or valve area <1.2 cm2) or mechanical mitral valve prosthesis
  • Required long-term warfarin therapy

Other salient features/characteristics:

  • Mean CHA2DS2-VASc score: 4.9
  • Mean HAS-BLED score: 3.0

Periprocedural characteristics, TAVR+LAAO vs. TAVR+medical therapy:

  • Mean additional periprocedural time: 44 minutes
  • Mean intravenous (IV) contrast volume: 126 vs. 82 mL
  • Acute kidney injury: 2.8% vs. 3.4%
  • Moderate-to-large pericardial effusion: 2.4% vs. 0.5%

Principal Findings:

The primary outcome, composite of all-cause mortality, stroke, and major/life-threatening bleeding at 2 years, for TAVR+LAAO vs. TAVR+medical therapy: 22.7 vs. 27.3 events per 100 patient-years (hazard ratio [HR] 0.86, 95% confidence interval [CI] 0.60-1.22; p for noninferiority < 0.001, p for superiority = 0.40).

Secondary outcomes for TAVR+LAAO vs. TAVR+medical therapy, events per 100 patient-years at 2 years:

  • All-cause mortality: 12.0 vs. 14.2 (HR 0.86, 95% CI 0.55-1.34)
  • Stroke: 3.4 vs. 4.6 (HR 0.76, 95% CI 0.33-1.77)
  • Major/life-threatening bleeding: 12.9 vs. 12.3 (HR 1.10, 95% CI 0.67-1.79)
  • Arterial or venous thromboembolism: 9.0% vs. 1.7% (HR 5.03, 95% CI 1.47-17.26)

Medication differences for TAVR+LAAO vs. TAVR+medical therapy at 2 years:

  • Single antiplatelet therapy alone: 69% vs. 15%
  • Any anticoagulation (warfarin or DOAC): 14% vs. 67%

Interpretation:

In patients with comorbid severe AS and AF, the WATCH-TAVR trial demonstrated that simultaneous TAVR and implantation of the WATCHMAN 2.5 device was noninferior to TAVR only with anticoagulation with respect to the primary composite outcome of all-cause death, stroke, and bleeding at 2 years. Moreover, despite increased periprocedural time and IV contrast use, rates of acute kidney injury were similar in the two arms. Notably, only 67% of the TAVR+medical therapy group were still on any anticoagulation at 2 years with 7.5% crossover to subsequent LAAO. This may reflect practical concerns regarding overall risk versus benefit for anticoagulation in this predominantly older population and may further support an LAAO strategy, which can safely be performed simultaneously with TAVR, to mitigate the risk of cardioembolic stroke. Implantation of the newer-generation WATCHMAN FLX, which may be managed with less intensive postprocedural anticoagulation or antiplatelet therapy, may reduce the transient increase in postprocedural bleeding seen in the TAVR+LAAO group.

This is the first prospective, randomized controlled trial to examine a combined TAVR+LAAO approach. Given the frequent comorbidity of AF with severe AS, as well as the low representation of such patients in prior WATCHMAN trials, the current data provide some evidence to support this treatment strategy in select patients with AS and AF. The cost-effectiveness of a combined strategy is unclear. Also, since LAAO typically requires general endotracheal anesthesia, a combined procedure could increase the complexity of the TAVR procedure, many of which are performed with moderate/conscious sedation in the current era.

References:

Kapadia SR, Krishnaswamy A, Whisenant B, et al. Concomitant Left Atrial Appendage Occlusion and Transcatheter Aortic Valve Replacement Among Patients With Atrial Fibrillation. Circulation 2023;Oct 24:[Epub ahead of print].

Presented by Dr. Samir R. Kapadia at the Transcatheter Cardiovascular Therapeutics meeting (TCT 2023), San Francisco, CA, October 24, 2023.

Clinical Topics: Valvular Heart Disease, Invasive Cardiovascular Angiography and Intervention

Keywords: Heart Valve Diseases, Structural Intervention, Transcatheter Cardiovascular Therapeutics, TCT23


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