
The publisher of a European Heart Rhythm Association journal is investigating a paper that lists the incorrect registration number for a clinical study of a widely used but controversial heart implant.
The paper, published in EP Europace in May, described a prospective study of the Watchman FLX, from Boston Scientific, for a procedure called left atrial appendage occlusion (LAAO) in 400 people with abnormal heart rhythms. The authors concluded the device was “feasible, safe, and resource efficient, achieving high procedural success and low complication rates.”
Cardiologists have warned of caveats with the device and the LAAO procedure itself, mainly that early studies found LAAO caused a “significantly higher rate of a primary composite endpoint that included stroke, systemic embolism, cardiovascular/unexplained death, and major bleeding.” A study earlier this year found LAAO with a Watchman device increased rates of stroke and other complications when compared to oral medications.
Continue reading Journal investigating paper on heart device with registration number for wrong trial






