Percutaneous Device Closure of Patent Foramen Ovale in Patients With Presumed Cryptogenic Stroke or Transient Ischemic Attack. The Mayo Clinic Experience

Monique A. Ford, Guy S. Reeder, Ryan J. Lennon, Robert D Jr. Brown, George W. Petty, Allison K. Cabalka, Frank Cetta, Donald J. Hagler

Research output: Contribution to journalArticle

33 Citations (Scopus)

Abstract

Objectives: We sought to determine safety, recurrence rates, and novel risk factors for recurrence in patients with cryptogenic stroke/transient ischemic attack (TIA) after patent foramen ovale closure. Background: Patent foramen ovale closure in patients with cryptogenic stroke/TIA remains highly controversial. There are limited data on long-term recurrence rates and their predictors in these patients. Methods: The records of all patients who underwent patent foramen ovale device closure between December 2001 and June 2006 were reviewed. Patients were seen for clinical follow-up at 3 months then followed annually via telephone. Primary end points were recurrent stroke/TIA. Kaplan-Meier methods were used to estimate recurrent event rates. Cox regression analysis was used to identify risk factors for recurrences. Results: There were 352 patients with cryptogenic stroke (n = 225) or TIA (n = 118) with a mean age of 53.4 years. The procedural complication rate was 3.4%. Recurrent events occurred in 8 patients: 7 strokes and 2 TIA, 1 patient had 2 recurrent strokes. The recurrence rate was 0.6% and 2.1% for stroke and 0.3% and 0.7% for TIA at 1 and 4 years, respectively. The combined end point of recurrent stroke/TIA occurred at a rate of 0.9% and 2.8% at 1 and 4 years, respectively. Risk factors for recurrences were elevated pulmonary artery pressure (hazard ratio [HR]: 1.12, p = 0.009), elevated right ventricular pressure (HR: 1.09, p = 0.04), factor V Leiden mutation (HR: 7.42, p = 0.014), and protein S deficiency (HR: 12.2, p = 0.002). Residual shunt and atrial septal aneurysm were not associated with recurrences. Conclusions: Patent foramen ovale device closure is safe and is associated with a low recurrence of stroke/TIA. Factors associated with recurrence are thrombophilia and elevated intracardiac pressures.

Original languageEnglish (US)
Pages (from-to)404-411
Number of pages8
JournalJACC: Cardiovascular Interventions
Volume2
Issue number5
DOIs
StatePublished - May 2009

Fingerprint

Patent Foramen Ovale
Transient Ischemic Attack
Stroke
Recurrence
Equipment and Supplies
Protein S Deficiency
Pressure
Thrombophilia
Ventricular Pressure
Telephone
Pulmonary Artery
Aneurysm
Regression Analysis
Safety
Mutation

Keywords

  • cryptogenic stroke
  • patent foramen ovale
  • transient ischemic attack

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Percutaneous Device Closure of Patent Foramen Ovale in Patients With Presumed Cryptogenic Stroke or Transient Ischemic Attack. The Mayo Clinic Experience. / Ford, Monique A.; Reeder, Guy S.; Lennon, Ryan J.; Brown, Robert D Jr.; Petty, George W.; Cabalka, Allison K.; Cetta, Frank; Hagler, Donald J.

In: JACC: Cardiovascular Interventions, Vol. 2, No. 5, 05.2009, p. 404-411.

Research output: Contribution to journalArticle

Ford, Monique A. ; Reeder, Guy S. ; Lennon, Ryan J. ; Brown, Robert D Jr. ; Petty, George W. ; Cabalka, Allison K. ; Cetta, Frank ; Hagler, Donald J. / Percutaneous Device Closure of Patent Foramen Ovale in Patients With Presumed Cryptogenic Stroke or Transient Ischemic Attack. The Mayo Clinic Experience. In: JACC: Cardiovascular Interventions. 2009 ; Vol. 2, No. 5. pp. 404-411.
@article{bfe203451afc4ef7a8c94fdbe08066e8,
title = "Percutaneous Device Closure of Patent Foramen Ovale in Patients With Presumed Cryptogenic Stroke or Transient Ischemic Attack. The Mayo Clinic Experience",
abstract = "Objectives: We sought to determine safety, recurrence rates, and novel risk factors for recurrence in patients with cryptogenic stroke/transient ischemic attack (TIA) after patent foramen ovale closure. Background: Patent foramen ovale closure in patients with cryptogenic stroke/TIA remains highly controversial. There are limited data on long-term recurrence rates and their predictors in these patients. Methods: The records of all patients who underwent patent foramen ovale device closure between December 2001 and June 2006 were reviewed. Patients were seen for clinical follow-up at 3 months then followed annually via telephone. Primary end points were recurrent stroke/TIA. Kaplan-Meier methods were used to estimate recurrent event rates. Cox regression analysis was used to identify risk factors for recurrences. Results: There were 352 patients with cryptogenic stroke (n = 225) or TIA (n = 118) with a mean age of 53.4 years. The procedural complication rate was 3.4{\%}. Recurrent events occurred in 8 patients: 7 strokes and 2 TIA, 1 patient had 2 recurrent strokes. The recurrence rate was 0.6{\%} and 2.1{\%} for stroke and 0.3{\%} and 0.7{\%} for TIA at 1 and 4 years, respectively. The combined end point of recurrent stroke/TIA occurred at a rate of 0.9{\%} and 2.8{\%} at 1 and 4 years, respectively. Risk factors for recurrences were elevated pulmonary artery pressure (hazard ratio [HR]: 1.12, p = 0.009), elevated right ventricular pressure (HR: 1.09, p = 0.04), factor V Leiden mutation (HR: 7.42, p = 0.014), and protein S deficiency (HR: 12.2, p = 0.002). Residual shunt and atrial septal aneurysm were not associated with recurrences. Conclusions: Patent foramen ovale device closure is safe and is associated with a low recurrence of stroke/TIA. Factors associated with recurrence are thrombophilia and elevated intracardiac pressures.",
keywords = "cryptogenic stroke, patent foramen ovale, transient ischemic attack",
author = "Ford, {Monique A.} and Reeder, {Guy S.} and Lennon, {Ryan J.} and Brown, {Robert D Jr.} and Petty, {George W.} and Cabalka, {Allison K.} and Frank Cetta and Hagler, {Donald J.}",
year = "2009",
month = "5",
doi = "10.1016/j.jcin.2008.12.015",
language = "English (US)",
volume = "2",
pages = "404--411",
journal = "JACC: Cardiovascular Interventions",
issn = "1936-8798",
publisher = "Elsevier Inc.",
number = "5",

}

TY - JOUR

T1 - Percutaneous Device Closure of Patent Foramen Ovale in Patients With Presumed Cryptogenic Stroke or Transient Ischemic Attack. The Mayo Clinic Experience

AU - Ford, Monique A.

AU - Reeder, Guy S.

AU - Lennon, Ryan J.

AU - Brown, Robert D Jr.

AU - Petty, George W.

AU - Cabalka, Allison K.

AU - Cetta, Frank

AU - Hagler, Donald J.

PY - 2009/5

Y1 - 2009/5

N2 - Objectives: We sought to determine safety, recurrence rates, and novel risk factors for recurrence in patients with cryptogenic stroke/transient ischemic attack (TIA) after patent foramen ovale closure. Background: Patent foramen ovale closure in patients with cryptogenic stroke/TIA remains highly controversial. There are limited data on long-term recurrence rates and their predictors in these patients. Methods: The records of all patients who underwent patent foramen ovale device closure between December 2001 and June 2006 were reviewed. Patients were seen for clinical follow-up at 3 months then followed annually via telephone. Primary end points were recurrent stroke/TIA. Kaplan-Meier methods were used to estimate recurrent event rates. Cox regression analysis was used to identify risk factors for recurrences. Results: There were 352 patients with cryptogenic stroke (n = 225) or TIA (n = 118) with a mean age of 53.4 years. The procedural complication rate was 3.4%. Recurrent events occurred in 8 patients: 7 strokes and 2 TIA, 1 patient had 2 recurrent strokes. The recurrence rate was 0.6% and 2.1% for stroke and 0.3% and 0.7% for TIA at 1 and 4 years, respectively. The combined end point of recurrent stroke/TIA occurred at a rate of 0.9% and 2.8% at 1 and 4 years, respectively. Risk factors for recurrences were elevated pulmonary artery pressure (hazard ratio [HR]: 1.12, p = 0.009), elevated right ventricular pressure (HR: 1.09, p = 0.04), factor V Leiden mutation (HR: 7.42, p = 0.014), and protein S deficiency (HR: 12.2, p = 0.002). Residual shunt and atrial septal aneurysm were not associated with recurrences. Conclusions: Patent foramen ovale device closure is safe and is associated with a low recurrence of stroke/TIA. Factors associated with recurrence are thrombophilia and elevated intracardiac pressures.

AB - Objectives: We sought to determine safety, recurrence rates, and novel risk factors for recurrence in patients with cryptogenic stroke/transient ischemic attack (TIA) after patent foramen ovale closure. Background: Patent foramen ovale closure in patients with cryptogenic stroke/TIA remains highly controversial. There are limited data on long-term recurrence rates and their predictors in these patients. Methods: The records of all patients who underwent patent foramen ovale device closure between December 2001 and June 2006 were reviewed. Patients were seen for clinical follow-up at 3 months then followed annually via telephone. Primary end points were recurrent stroke/TIA. Kaplan-Meier methods were used to estimate recurrent event rates. Cox regression analysis was used to identify risk factors for recurrences. Results: There were 352 patients with cryptogenic stroke (n = 225) or TIA (n = 118) with a mean age of 53.4 years. The procedural complication rate was 3.4%. Recurrent events occurred in 8 patients: 7 strokes and 2 TIA, 1 patient had 2 recurrent strokes. The recurrence rate was 0.6% and 2.1% for stroke and 0.3% and 0.7% for TIA at 1 and 4 years, respectively. The combined end point of recurrent stroke/TIA occurred at a rate of 0.9% and 2.8% at 1 and 4 years, respectively. Risk factors for recurrences were elevated pulmonary artery pressure (hazard ratio [HR]: 1.12, p = 0.009), elevated right ventricular pressure (HR: 1.09, p = 0.04), factor V Leiden mutation (HR: 7.42, p = 0.014), and protein S deficiency (HR: 12.2, p = 0.002). Residual shunt and atrial septal aneurysm were not associated with recurrences. Conclusions: Patent foramen ovale device closure is safe and is associated with a low recurrence of stroke/TIA. Factors associated with recurrence are thrombophilia and elevated intracardiac pressures.

KW - cryptogenic stroke

KW - patent foramen ovale

KW - transient ischemic attack

UR - http://www.scopus.com/inward/record.url?scp=65549121300&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=65549121300&partnerID=8YFLogxK

U2 - 10.1016/j.jcin.2008.12.015

DO - 10.1016/j.jcin.2008.12.015

M3 - Article

C2 - 19463462

AN - SCOPUS:65549121300

VL - 2

SP - 404

EP - 411

JO - JACC: Cardiovascular Interventions

JF - JACC: Cardiovascular Interventions

SN - 1936-8798

IS - 5

ER -