Safety profiles of percutaneous left atrial appendage closure devices

An analysis of the Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database from 2009 to 2016

Mohammad Ali Jazayeri, Venkat Vuddanda, Mohit K. Turagam, Valay Parikh, Madhav Lavu, Donita Atkins, Matthew Earnest, Luigi Di Biase, Andrea Natale, David Wilber, Yeruva Madhu Reddy, Dhanunjaya R. Lakkireddy

Research output: Contribution to journalArticle

9 Citations (Scopus)

Abstract

Background: Percutaneous left atrial appendage closure (LAAC) is a viable option for AF patients who are unable to tolerate long-term oral anticoagulation (OAC). Objective: We sought to assess the safety of two commonly used percutaneous devices for LAA closure in the United States by analysis of surveillance data from the FDA Manufacturer and User Facility Device Experience (MAUDE) database. Methods: The MAUDE database was queried between May 1, 2006 and May 1, 2016 for LARIAT® (SentreHEART Inc., Redwood City, CA, USA) and WATCHMAN™ (Boston Scientific Corp., Marlborough, MA, USA) devices. Among 622 retrieved medical device reports, 356 unique and relevant reports were analyzed. The cumulative incidence of safety events was calculated over the study period and compared between the two devices. Results: LAAC was performed with LARIAT in 4,889 cases. WATCHMAN was implanted in 2,027 patients prior to FDA approval in March 2015 and 3,822 patients postapproval. The composite outcome of stroke/TIA, pericardiocentesis, cardiac surgery, and death occurred more frequently with WATCHMAN (cumulative incidence, 1.93% vs. 1.15%; P = 0.001). The same phenomenon was observed when comparing the WATCHMAN pre- and postapproval experiences for the composite outcome, as well as device embolization, cardiac surgery, and myocardial infarction. Conclusions: MAUDE-reported data show that postapproval, new technology adoption is fraught with increased complications. Improved collaboration between operators, device manufacturers, and regulators can better serve patients through increased transparency and practical postmarket training and monitoring mechanisms.

Original languageEnglish (US)
JournalJournal of Cardiovascular Electrophysiology
DOIs
StateAccepted/In press - 2017

Fingerprint

Atrial Appendage
United States Food and Drug Administration
Databases
Safety
Equipment and Supplies
Thoracic Surgery
Sequoia
Pericardiocentesis
Incidence
Stroke
Myocardial Infarction
Technology

Keywords

  • Air embolism
  • Atrial fibrillation
  • Cardiac surgery
  • Food and Drug Administration
  • LARIAT
  • Left atrial appendage closure
  • Left atrial appendage occlusion
  • Malfunction
  • Mortality
  • Outcomes
  • Pericardial effusion
  • Stroke
  • Transient ischemic attack
  • WATCHMAN

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Physiology (medical)

Cite this

Safety profiles of percutaneous left atrial appendage closure devices : An analysis of the Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database from 2009 to 2016. / Jazayeri, Mohammad Ali; Vuddanda, Venkat; Turagam, Mohit K.; Parikh, Valay; Lavu, Madhav; Atkins, Donita; Earnest, Matthew; Di Biase, Luigi; Natale, Andrea; Wilber, David; Reddy, Yeruva Madhu; Lakkireddy, Dhanunjaya R.

In: Journal of Cardiovascular Electrophysiology, 2017.

Research output: Contribution to journalArticle

Jazayeri, Mohammad Ali ; Vuddanda, Venkat ; Turagam, Mohit K. ; Parikh, Valay ; Lavu, Madhav ; Atkins, Donita ; Earnest, Matthew ; Di Biase, Luigi ; Natale, Andrea ; Wilber, David ; Reddy, Yeruva Madhu ; Lakkireddy, Dhanunjaya R. / Safety profiles of percutaneous left atrial appendage closure devices : An analysis of the Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database from 2009 to 2016. In: Journal of Cardiovascular Electrophysiology. 2017.
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abstract = "Background: Percutaneous left atrial appendage closure (LAAC) is a viable option for AF patients who are unable to tolerate long-term oral anticoagulation (OAC). Objective: We sought to assess the safety of two commonly used percutaneous devices for LAA closure in the United States by analysis of surveillance data from the FDA Manufacturer and User Facility Device Experience (MAUDE) database. Methods: The MAUDE database was queried between May 1, 2006 and May 1, 2016 for LARIAT{\circledR} (SentreHEART Inc., Redwood City, CA, USA) and WATCHMAN™ (Boston Scientific Corp., Marlborough, MA, USA) devices. Among 622 retrieved medical device reports, 356 unique and relevant reports were analyzed. The cumulative incidence of safety events was calculated over the study period and compared between the two devices. Results: LAAC was performed with LARIAT in 4,889 cases. WATCHMAN was implanted in 2,027 patients prior to FDA approval in March 2015 and 3,822 patients postapproval. The composite outcome of stroke/TIA, pericardiocentesis, cardiac surgery, and death occurred more frequently with WATCHMAN (cumulative incidence, 1.93{\%} vs. 1.15{\%}; P = 0.001). The same phenomenon was observed when comparing the WATCHMAN pre- and postapproval experiences for the composite outcome, as well as device embolization, cardiac surgery, and myocardial infarction. Conclusions: MAUDE-reported data show that postapproval, new technology adoption is fraught with increased complications. Improved collaboration between operators, device manufacturers, and regulators can better serve patients through increased transparency and practical postmarket training and monitoring mechanisms.",
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author = "Jazayeri, {Mohammad Ali} and Venkat Vuddanda and Turagam, {Mohit K.} and Valay Parikh and Madhav Lavu and Donita Atkins and Matthew Earnest and {Di Biase}, Luigi and Andrea Natale and David Wilber and Reddy, {Yeruva Madhu} and Lakkireddy, {Dhanunjaya R.}",
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T1 - Safety profiles of percutaneous left atrial appendage closure devices

T2 - An analysis of the Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database from 2009 to 2016

AU - Jazayeri, Mohammad Ali

AU - Vuddanda, Venkat

AU - Turagam, Mohit K.

AU - Parikh, Valay

AU - Lavu, Madhav

AU - Atkins, Donita

AU - Earnest, Matthew

AU - Di Biase, Luigi

AU - Natale, Andrea

AU - Wilber, David

AU - Reddy, Yeruva Madhu

AU - Lakkireddy, Dhanunjaya R.

PY - 2017

Y1 - 2017

N2 - Background: Percutaneous left atrial appendage closure (LAAC) is a viable option for AF patients who are unable to tolerate long-term oral anticoagulation (OAC). Objective: We sought to assess the safety of two commonly used percutaneous devices for LAA closure in the United States by analysis of surveillance data from the FDA Manufacturer and User Facility Device Experience (MAUDE) database. Methods: The MAUDE database was queried between May 1, 2006 and May 1, 2016 for LARIAT® (SentreHEART Inc., Redwood City, CA, USA) and WATCHMAN™ (Boston Scientific Corp., Marlborough, MA, USA) devices. Among 622 retrieved medical device reports, 356 unique and relevant reports were analyzed. The cumulative incidence of safety events was calculated over the study period and compared between the two devices. Results: LAAC was performed with LARIAT in 4,889 cases. WATCHMAN was implanted in 2,027 patients prior to FDA approval in March 2015 and 3,822 patients postapproval. The composite outcome of stroke/TIA, pericardiocentesis, cardiac surgery, and death occurred more frequently with WATCHMAN (cumulative incidence, 1.93% vs. 1.15%; P = 0.001). The same phenomenon was observed when comparing the WATCHMAN pre- and postapproval experiences for the composite outcome, as well as device embolization, cardiac surgery, and myocardial infarction. Conclusions: MAUDE-reported data show that postapproval, new technology adoption is fraught with increased complications. Improved collaboration between operators, device manufacturers, and regulators can better serve patients through increased transparency and practical postmarket training and monitoring mechanisms.

AB - Background: Percutaneous left atrial appendage closure (LAAC) is a viable option for AF patients who are unable to tolerate long-term oral anticoagulation (OAC). Objective: We sought to assess the safety of two commonly used percutaneous devices for LAA closure in the United States by analysis of surveillance data from the FDA Manufacturer and User Facility Device Experience (MAUDE) database. Methods: The MAUDE database was queried between May 1, 2006 and May 1, 2016 for LARIAT® (SentreHEART Inc., Redwood City, CA, USA) and WATCHMAN™ (Boston Scientific Corp., Marlborough, MA, USA) devices. Among 622 retrieved medical device reports, 356 unique and relevant reports were analyzed. The cumulative incidence of safety events was calculated over the study period and compared between the two devices. Results: LAAC was performed with LARIAT in 4,889 cases. WATCHMAN was implanted in 2,027 patients prior to FDA approval in March 2015 and 3,822 patients postapproval. The composite outcome of stroke/TIA, pericardiocentesis, cardiac surgery, and death occurred more frequently with WATCHMAN (cumulative incidence, 1.93% vs. 1.15%; P = 0.001). The same phenomenon was observed when comparing the WATCHMAN pre- and postapproval experiences for the composite outcome, as well as device embolization, cardiac surgery, and myocardial infarction. Conclusions: MAUDE-reported data show that postapproval, new technology adoption is fraught with increased complications. Improved collaboration between operators, device manufacturers, and regulators can better serve patients through increased transparency and practical postmarket training and monitoring mechanisms.

KW - Air embolism

KW - Atrial fibrillation

KW - Cardiac surgery

KW - Food and Drug Administration

KW - LARIAT

KW - Left atrial appendage closure

KW - Left atrial appendage occlusion

KW - Malfunction

KW - Mortality

KW - Outcomes

KW - Pericardial effusion

KW - Stroke

KW - Transient ischemic attack

KW - WATCHMAN

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DO - 10.1111/jce.13362

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