They told me that it would prevent a stroke. No one told me the truth.

"Unless new data emerges, percutaneous closure of the left atrial appendage may become one of cardiology's biggest errors."

— Dr. John Mandrola, Cardiac Electrophysiologist [Read Source]

"The Watchman device does not prevent strokes. When compared in the best test of medicine, the randomized controlled trial (RCT), the device was inferior to warfarin."

— Dr. John Mandrola [Read Source]

"The latest evidence again shows the Watchman is inferior to standard of care with blood thinners... risk from the Watchman procedure itself is not trivial."

— Dr. Gregory Katz, Cardiologist [Read Source]

"Doctors could potentially collect thousands in fees for a one-hour procedure... but they get no additional fee for writing a prescription for a blood thinner."

— Dr. Miguel Valderrábano, Houston Methodist [Read Source]

"Over 600,000 procedures have been performed worldwide... The problem is that the intuition has consistently outrun the evidence."

— Dr. John Mandrola, M. Ruzieh, & A. Foy [Read Source]

"We need to err on the side of safety when putting new things on the market... With Watchman we have ways of preventing stroke that are very effective."

— Dr. Rita Redberg, Former Editor, JAMA Internal Medicine [Read Source]

"The honest scorecard is that the device is associated with 17 more strokes vs 4 fewer major bleeds. That is a devastating trade-off..."

— Cardiology Trials Substack Analysts [Read Source]

"Left atrial appendage closure was associated with a higher risk of stroke, systemic embolism, major bleeding and cardiovascular death..."

— Dr. Ulf Landmesser, Chair of Cardiology, Charité Berlin [Read Source]

"Proponents say we should use the device for patients who cannot take blood thinners... But these patients were not included in trials."

— Dr. John Mandrola [Read Source]

"I am still shocked that percutaneous left atrial appendage closure is so popular... Our acceptance of this procedure baffles me."

— Dr. John Mandrola [Read Source]

"When thrombus forms on the exposed metal face of an implanted Watchman plug, patients face a 3- to 4-fold increase in ischemic stroke risk..."

— Dr. John Mandrola [Read Source]

"Patients at high risk are probably not optimal candidates for this procedure."

— Dr. Ulf Landmesser, Principal Investigator, CLOSURE-AF [Read Source]

"[LAA] closure failed to fulfill its theoretical promise to become an alternative treatment to best medical therapy..."

— Dr. Petr Widimský, ACC/NEJM Commentator [Read Source]

"We actually saw an increase of the primary outcome of stroke, systemic embolism, and major bleeds in the occlusion arm..."

— Dr. Jeff Healey, McMaster University [Read Source]

"Surgical closure cut off or clipped the appendage from the outside... efforts to plug the appendage with devices placed via the leg have failed to show benefit."

— Dr. John Mandrola [Read Source]

"On the question of reasonable assurance of effectiveness, the Panel vote was unfavorable (6 yes to 7 no)."

— FDA Circulatory System Devices Advisory Panel [Read Source]

"Pericardial effusion was the most common adverse event reported in the MAUDE database (42%), followed by device-related thrombus, stroke, and device embolization."

— Singh et al., Newark Beth Israel Medical Center [Read Source]

"Of the 45 adverse events reported to the FDA, 34 (approximately 75%) resulted in the need to perform emergency heart surgery."

— FDA Official Safety Communication (Lariat Suture Device) [Read Source]

"Nearly a decade after FDA approval, we still have to debate the fundamental efficacy and safety of Watchman... Explain this one to me."

— Dr. John Mandrola [Read Source]

"Data regarding hard clinical outcomes (such as long-term stroke prevention), rather than just measuring 'leak,' will be important..."

— Dr. Sanjay Kaul, Cedars-Sinai Medical Center [Read Source]

"Unless new data emerges, percutaneous closure of the left atrial appendage may become one of cardiology's biggest errors."

— Dr. John Mandrola, Cardiac Electrophysiologist [Read Source]

"The Watchman device does not prevent strokes. When compared in the best test of medicine, the randomized controlled trial (RCT), the device was inferior to warfarin."

— Dr. John Mandrola [Read Source]

"The latest evidence again shows the Watchman is inferior to standard of care with blood thinners... risk from the Watchman procedure itself is not trivial."

— Dr. Gregory Katz, Cardiologist [Read Source]

"Doctors could potentially collect thousands in fees for a one-hour procedure... but they get no additional fee for writing a prescription for a blood thinner."

— Dr. Miguel Valderrábano, Houston Methodist [Read Source]

"Over 600,000 procedures have been performed worldwide... The problem is that the intuition has consistently outrun the evidence."

— Dr. John Mandrola, M. Ruzieh, & A. Foy [Read Source]