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Closing the left atrial appendage (LAA) with the Watchman device, already shown to be noninferior to warfarin therapy for stroke prevention in patients with nonvalvular atrial fibrillation (A-fib), also improves quality of life measures. Results from a subanalysis of the PROTECT AF trial were scheduled to appear online February 26, 2013, ahead of print in the Journal of the American College of Cardiology.
PROTECT AF, first published in August 2009 in the Lancet, randomized patients with nonvalvular A-fib to percutaneous LAA closure with the Watchman device (Atritech, Plymouth, MN; n = 463) or ongoing warfarin treatment alone (n = 244). The most recent data from the trial confirmed the noninferiority of the device for the primary composite efficacy endpoint (stroke, systemic embolism, and cardiovascular or unexplained death), although there was an increase in the primary composite safety outcome (procedure-related events and major bleeding).
For the subanalysis, researchers led by David Holmes Jr, MD, of the Mayo Clinic (Rochester, MN), assessed QOL measures at baseline and 12 months using the SF-12 survey in 547 patients from the trial.
Physical Functioning Improves
Baseline mean total physical scores for the entire cohort were below the norm for this population, while baseline total mental scores were slightly above average. At 12 months, patients who received the Watchman device (n = 361) showed improvements in total physical score, physical functioning, and physical role limitations, while warfarin patients (n = 186) experienced decreases (table 1).
Table 1. SF-12 Quality-of-Life Measurements at 12 Months
Change from Baseline
Watchman Group(n = 361)
Warfarin Group(n = 186)
Total Physical Score
0.4 ± 9.0
-2.0 ± 8.5
0.1 ± 11.7
-3.0 ± 10.9
Physical Role Limitation
0.4 ± 10.0
-2.5 ± 10.1
On an individual basis, the total physical score improved in 34.9% and remained unchanged in 29.9% of Watchman patients compared with 24.7% and 31.7%, respectively, in controls (P = 0.01). There was no difference, however, between the Watchman and warfarin groups in change in total mental score (P = 0.64), although a more detailed assessment revealed mental health improvement in 33.0% of the Watchman group vs. 22.6% of controls, a difference which just missed significance (P = 0.06).
On subgroup analysis, patients were found to benefit from Watchman implantation whether they were warfarin naïve or already on the vitamin K antagonist. However, warfarin-naïve patients benefited the most, showing improvements in total physical score, physical functioning, physical role limitation, and pain with Watchman implantation (table 2).
Table 1. SF-12 Quality-of-Life Measurements at 12 Months in Warfarin-Naïve Patients
Watchman Group(n = 75)
Warfarin Group(n = 32)
1.3 ± 8.8
-3.6 ± 6.7
1.0 ± 10.5
-2.8 ± 10.0
0.5 ± 10.4
-4.9 ± 9.9
1.7 ± 10.8
-2.6 ± 10.8
As with the overall population, there was no difference between the Watchman and control groups in change in total mental scores.
Noting that the improvements mainly came in the area of physical functioning, the authors conclude that “[t]he main finding in this study is that patients with nonvalvular [A-fib] at risk for stroke treated with [LAA] closure have favorable QOL at 12 months compared to patients treated with warfarin.”
They also cite the overall decreases in QOL scores in the group on long-term warfarin therapy.
No More Warfarin = Better QOL
In explaining the quality of life outcomes, the authors note that “patients who receive the device and are reassured during follow-up that the device is working . . . [are] empowered in a sense to be more active and behave in that way. The patients on warfarin on the other hand continue to have the blood tests, and the dietary issues that we talk to them about and the bleeding hazard and so they may restrict their activities more.”
In the warfarin-naïve patients, specifically, “avoiding the aforementioned issues with anticoagulation with warfarin may lead to improved QOL in these patients,” they observe.
In a telephone interview with TCTMD, Ziyad M. Hijazi, MD, MPH, of Rush University Medical Center (Chicago, IL), called the study “a good one showing that closing the appendage, which is the source of the clot in 90% of cases, is definitely worthwhile for a lot of these patients and their physical activity improves even if they don’t have ablation.”
The improvement, he added, stems from no longer needing warfarin. “At 1 year, there was significant improvement because the majority of these patients who received closure were actually off coumadin,” Dr. Hijazi said. “By taking them off the coumadin, these patients feel great, they eat better, exercise more, and could walk better without the fear of falling and having a bleed.”
While he has not used the Watchman device specifically, Dr. Hijazi added that he has seen the same trends in his own practice after using off-label devices.
The only aspect that disappointed Dr. Hijazi regarding the study was the lack of improvement in mental functioning after LAA closure. “But I’m not surprised because there’s not much that they have done to these patients to change their mental status,” he said.
Alli O, Doshi S, Kar S, et al. Quality of life assessment in the randomized PROTECT AF trial of patients at risk for stroke with non-valvular atrial fibrillation. J Am Coll Cardiol. 2013;Epub ahead of print.