SWISS-APERO at 1 year: LAA closure outcomes similar for Amulet, Watchman devices
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Key takeaways:
- Rates of patency and device-related thrombus were similar at 13 months for patients undergoing left atrial appendage closure with two leading devices.
- Clinical outcomes did not differ between groups.
SAN FRANCISCO — One-year data from the SWISS-APERO study show similar clinical outcomes and rates of patent left atrial appendages for patients undergoing LAA closure with either the Amulet or Watchman FLX devices, a speaker reported.
Residual LAA patency after LAA closure has been associated with higher thromboembolic risk, especially when detected remotely after the procedure, Roberto Galea, MD, research associate and consultant interventional cardiologist in the department of cardiology at Bern University, Switzerland, said during a press conference at TCT 2023. The Watchman FLX (Boston Scientific) and the Amplatzer Amulet LAA Occluder (Abbott) are the two most frequently used devices for LAA closure worldwide. The investigator-initiated SWISS-APERO study is the first head-to-head trial to compare device outcomes.
“In patients who are deemed good candidates for both devices, Amulet and Watchman seem to be associated to similar rates of closure and adverse events,” SWISS-APERO study chair Marco Valgimigli, MD, PhD, FESC, deputy head of cardiology at Cardiocentro Ticino Institute in Lugano, Switzerland, told Healio. “At 13 months’ follow-up, the rates of patent LAA were similar with Amulet or Watchman, as were the rates of clinical events in the study groups.”
Similar patency, clinical outcomes
As Healio previously reported, initial findings from SWISS-APERO, presented at TCT 2021, showed a similar rate of the primary endpoint of crossover to the other device or residual LAA patency at 45 days. However, the Amulet device was associated with less peridevice leak, more procedural complications and similar 45-day clinical outcomes compared with the Watchman FLX.
Researchers randomly assigned 221 patients with atrial fibrillation at high bleeding risk who had suitable LAA morphology and no LAA thrombus to undergo LAA closure using the Amulet (n = 111) or Watchman (n = 110) devices. In the Watchman group, 22.7% had a procedure with the Watchman 2.5 device; the rest had a procedure with Watchman FLX.
The findings were simultaneously published in Circulation.
At 13 months, 75.7% of patients who received an Amulet device and 72.2% who received a Watchman device underwent CT angiography. Researchers observed patency in 53.6% of patients who received an Amulet device and in 48.8% of patients who received a Watchman 2.5 or FLX device (RR = 1.1; 95% CI, 0.81-1.48; P = .537). LAA patency subtypes were similarly distributed between groups, Galea said.
Intradevice leak occurred in 23.8% of Amulet patients and 17.5% of Watchman patients (RR = 1.36; 95% CI, 0.74-2.51; P = .319). Side-gap leaks occurred in 28.6% of Amulet patients and in 27.5% of Watchman patients (RR = 1.04; 95% CI, 0.64-1.7; P = .879).
The composite endpoint of CV death, ischemic stroke and systemic embolism, cerebrovascular events or bleeding was comparable between groups, Galea said.
Follow-up continues
Galea said that results remined “entirely consistent” only when comparing Watchman FLX with Amulet.
“In the SWISS-APERO trial, we will follow the enrolled patients for 5 years after randomization with the aim of detecting relevant differences between the two device groups at very long-term,” Galea told Healio. “However, larger, multicenter, randomized controlled trials that are adequately powered are strongly needed to better compare the clinical profile of the two devices.”
Valgimigli noted that, in absolute terms, the rates of patent LAA were still “quite high” for both devices.
“So, one would need to understand whether perfect closure is key to optimizing the results or whether a minor patency would not affect long term outcomes,” Valgimigli told Healio. “We also need to learn how to improve the devices and procedures to obtain perfect short- and long-term results. There is still a major gap in knowledge on what antithrombotic treatment should be selected after LAA closure. Finally, large trials comparing LAA closure vs. oral anticoagulation are highly needed and, luckily, are underway.”
Reference:
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Poonam Velagapudi, MD, FACC
These data show that both the Watchman 2.5 and Amulet LAAO devices have similar rates of closure and device related thrombosis at 13 months. There is no difference in clinical outcomes. Thus, we have more options for patients with atrial fibrillation who qualify for LAA closure.
The operators may use the device that they are more comfortable with, but the take-home from these data is one could use either device for patients whose LAA anatomy is amenable to use of both devices. Since this trial enrolled patients eligible for either device, it does not tell us which LAAO device is appropriate for which appendage. From my experience, the Amulet device is useful in patients with very small or very large appendages because of its range in size availability. But again, one cannot draw conclusions about that from these data.
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Galea R, et al. Late-breaking clinical science: Session I, in collaboration with the Journal of the American College of Cardiology. Presented at: TCT Scientific Symposium; Oct. 23-26, 2023; San Francisco (hybrid meeting).
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