Patent Foramen Ovale Closure in Older Patients With Stroke

被引：0

作者：

Wang, Andy Y. ^{[1
]}

Rothwell, Peter M. ^{[2
]}

Nelson, Jason ^{[1
]}

Saver, Jeffrey L. ^{[3
,4
]}

Kasner, Scott E. ^{[5
]}

Carroll, John ^{[6
]}

Mas, Jean-Louis ^{[7
,8
]}

Derumeaux, Genevieve ^{[9
]}

Chatellier, Gilles ^{[10
]}

Furlan, Anthony J.

Herrmann, Howard C. ^{[11
,12
]}

Jueni, Peter ^{[13
]}

Kim, Jong S. ^{[14
]}

Koethe, Benjamin ^{[1
]}

Lee, Pil H. ^{[15
]}

Lefebvre, Benedicte ^{[11
,12
]}

Mattle, Heinrich P. ^{[16
]}

Meier, Bernhard ^{[17
]}

Reisman, Mark ^{[18
]}

Smalling, Richard W. ^{[19
]}

Sondergaard, Lars ^{[20
]}

Song, Jae-Kwan ^{[21
]}

Di Angelantonio, Emanuele ^{[22
,23
,24
,25
]}

Ditullio, Marco

Elkind, Mitchell S. V.

Homma, Shunichi

Jaigobin, Cheryl ^{[26
]}

Michel, Patrik

Mono, Marie-Luise ^{[27
,28
]}

Nedeltchev, Krassen ^{[27
,29
]}

Papetti, Federica

Serena, Joaquin

Weimar, Christian

Li, Linxin ^{[2
]}

Mazzucco, Sara ^{[2
]}

Silver, Louise E. ^{[2
]}

van Klaveren, David ^{[1
]}

Thaler, David E.

Kent, David M. ^{[1
]}

机构：

[1] Tufts Med Ctr, Predict Analyt & Comparat Effectiveness PACE Ctr, Inst Clin Res & Hlth Policy Studies ICRHPS, Boston, MA 02111 USA

[2] Univ Oxford, Dept Clin Neurol, London, England

[3] Univ Calif Los Angeles, Comprehens Stroke Ctr, David Geffen Sch Med, Los Angeles, CA USA

[4] Univ Calif Los Angeles, David Geffen Sch Med, Dept Neurol, Los Angeles, CA USA

[5] Univ Penn, Comprehens Stroke Ctr, Med Ctr, Dept Neurol, Philadelphia, PA USA

[6] Univ Colorado Denver, Dept Med, Div Cardiol, Aurora, CO USA

[7] Univ Paris Cite, Inst Psychiat & Neurosci Paris IPNP, INSERM U1266, Paris, France

[8] Hop St Anne, GHU Paris Psychiat & Neurosci, Paris, France

[9] Univ Paris Est Creteil UPEC, Hop Henri Mondor, AP HP, Dept Physiol, Creteil, France

[10] Hop Europeen Georges Pompidou, AP HP, Ctr Invest Clin, Unite Rech Clin, Paris, France

[11] Case Western Reserve Univ, Dept Neurol, Cleveland, OH USA

[12] Univ Penn, Div Cardiovasc Med, Perelman Sch Med, Philadelphia, PA USA

[13] Univ Oxford, Dept Populat Hlth, Oxford, England

[14] Univ Ulsan, Gangneung Asan Hosp, Coll Med, Dept Neurol, Seoul, South Korea

[15] Univ Ulsan, Coll Med, Asan Med Ctr, Dept Cardiol, Seoul, South Korea

[16] Bern Univ Hosp, Dept Neurol, Bern, Switzerland

[17] Univ Bern, Med Fac, Bern, Switzerland

[18] Weill Cornell Med Ctr, Cardiol Dept, Cornell, NY USA

[19] UTHealth McGovern Med Sch & Mem Hermann Heart & Va, Dept Med, Div Cardiol, Houston, TX USA

[20] Dept Cardiol, Copenhagen Univ Hosp, Rigshosp, Copenhagen, Denmark

[21] Univ Ulsan, Heart Inst, Coll Med, Asan Med Ctr,Div Cardiol, Seoul, South Korea

[22] Univ Cambridge, Dept Publ Hlth & Primary Care, BHF Cardiovasc Epidemiol Unit, Cambridge, England

[23] Univ Cambridge, Addenbrookes Hosp, Victor Phillip Dahdaleh Heart & Lung Res Inst EDA, BHF Ctr Res Excellence, Cambridge, England

[24] Wellcome Genome Campus & Univ Cambridge, Hlth Data Res UK Cambridge, Hinxton, England

[25] Human Technopole, Milan, Italy

[26] Columbia Univ, Vagelos Coll Phys & Surg, Mailman Sch Publ Hlth, Dept Epidemiol, New York, NY USA

[27] Lausanne Univ Hosp, Stroke Ctr, Dept Neurol, Neurol Serv, Lausanne, Switzerland

[28] Univ Bern, Dept Neurol, Bern, Switzerland

[29] Cantonal Hosp Aarau, Dept Neurol, Stadtspital Zurich, Aarau, Switzerland

来源：

NEUROLOGY | 2024年 / 102卷 / 10期

关键词：

CRYPTOGENIC STROKE; MEDICAL THERAPY; EMBOLISM; RISK; GENDER; IMPACT; AGE;

D O I：

暂无

中图分类号：

R74 [神经病学与精神病学];

学科分类号：

摘要：

Background and ObjectivesWhether patent foramen ovale (PFO) closure benefits older patients with PFO and cryptogenic stroke is unknown because randomized controlled trials (RCTs) have predominantly enrolled patients younger than 60 years of age. Our objective was to estimate anticipated effects of PFO closure in older patients to predict the numbers needed to plan an RCT.MethodsEffectiveness estimates are derived from major observational studies (Risk of Paradoxical Embolism [RoPE] Study and Oxford Vascular Study, together referred to as the "RoPE-Ox" database) and all 6 major RCTs (Systematic, Collaborative, PFO Closure Evaluation [SCOPE] Consortium). To estimate stroke recurrence risk, observed outcomes were calculated for patients older than 60 years in the age-inclusive observational databases (n = 549). To estimate the reduction in the rate of recurrent stroke associated with PFO closure vs medical therapy based on the RoPE score and the presence of high-risk PFO features, a Cox proportional hazards regression model was developed on the RCT data in the SCOPE database (n = 3,740). These estimates were used to calculate sample sizes required for a future RCT.ResultsFive-year risk of stroke recurrence using Kaplan-Meier estimates was 13.7 (95% CI 10.5-17.9) overall, 14.9% (95% CI 10.2-21.6) in those with high-risk PFO features. Predicted relative reduction in the event rate with PFO closure was 12.9% overall, 48.8% in those with a high-risk PFO feature. Using these estimates, enrolling all older patients with cryptogenic stroke and PFO would require much larger samples than those used for prior PFO closure trials, but selectively enrolling patients with high-risk PFO features would require totals of 630 patients for 90% power and 471 patients for 80% power, with an average of 5 years of follow-up.DiscussionBased on our projections, anticipated effect sizes in older patients with high-risk features make a trial in these subjects feasible. With lengthening life expectancy in almost all regions of the world, the utility of PFO closure in older adults is increasingly important to explore.

引用

页数：11

共 32 条

[1] Transcatheter Closure of Patent Foramen Ovale in Older Patients With Cryptogenic Thromboembolic Events [J].

Alper, Alberto ;

Guedeny, Paul ;

Horlick, Eric ;

Nombela-Franco, Luis ;

Freixa, Xavier ;

Pascual, Isaac ;

Mesnier, Jules ;

Houde, Christine ;

Abrahamyan, Lusine ;

Montalescot, Gilles ;

Rodes-Cabau, Josep .

CIRCULATION-CARDIOVASCULAR INTERVENTIONS, 2022, 15 (07) :557-565

[2] Patent Foramen Ovale in Cryptogenic Stroke Incidental or Pathogenic? [J].

Alsheikh-Ali, Alawi A. ;

Thaler, David E. ;

Kent, David M. .

STROKE, 2009, 40 (07) :2349-2355

[3] Understanding and Meeting the Needs of the Older Population: A Global Challenge [J].

Bergman, Howard ;

Karunananthan, Sathya ;

Robledo, Luis M. G. ;

Brodsky, Jenny ;

Chan, Piu ;

Cheung, Maria ;

Bovet, Pascal .

CANADIAN GERIATRICS JOURNAL, 2013, 16 (02) :61-65

[4] Closure of Patent Foramen Ovale versus Medical Therapy after Cryptogenic Stroke [J].

Carroll, John D. ;

Saver, Jeffrey L. ;

Thaler, David E. ;

Smalling, Richard W. ;

Berry, Scott ;

MacDonald, Lee A. ;

Marks, David S. ;

Tirschwell, David L. .

NEW ENGLAND JOURNAL OF MEDICINE, 2013, 368 (12) :1092-1100

[5] The impact of age and gender on right ventricular diastolic function among healthy adults [J].

D'Andrea, Antonello ;

Vriz, Olga ;

Carbone, Andreina ;

Ferrara, Francesco ;

Di Maio, Marco ;

Cocchia, Rosangela ;

Tagliamonte, Gianluigi ;

Acri, Edwige ;

Driussi, Caterina ;

Pezzullo, Enrica ;

Citro, Rodolfo ;

Cittadini, Antonio ;

Calabro, Raffaele ;

Russo, Maria Giovanna ;

Bossone, Eduardo .

JOURNAL OF CARDIOLOGY, 2017, 70 (3-4) :387-395

[6] Proposal for Updated Nomenclature and Classification of Potential Causative Mechanism in Patent Foramen Ovale-Associated Stroke [J].

Elgendy, Akram Y. ;

Saver, Jeffrey L. ;

Amin, Zahid ;

Boudoulas, Konstantinos Dean ;

Carroll, John D. ;

Elgendy, Islam Y. ;

Grunwald, Iris Q. ;

Gertz, Zachary M. ;

Hijazi, Ziyad M. ;

Horlick, Eric M. ;

Kasner, Scott E. ;

Kent, David M. ;

Kumar, Preetham ;

Kavinsky, Clifford J. ;

Liebeskind, David S. ;

Lutsep, Helmi ;

Mojadidi, Mohammad K. ;

Messe, Steven R. ;

Mas, Jean-Louis ;

Mattle, Heinrich P. ;

Meier, Bernhard ;

Mahmoud, Ahmad ;

Mahmoud, Ahmed N. ;

Nietlispach, Fabian ;

Patel, Nimesh K. ;

Rhodes, John F. ;

Reisman, Mark ;

Sommer, Robert J. ;

Sievert, Horst ;

Sondergaard, Lars ;

Zaman, Muhammad O. ;

Thaler, David ;

Tobis, Jonathan M. .

JAMA NEUROLOGY, 2020, 77 (07) :878-886

[7] Patent foramen ovale and cryptogenic stroke in older patients [J].

Handke, Michael ;

Harloff, Andreas ;

Olschewski, Manfred ;

Hetzel, Andreas ;

Geibel, Annette .

NEW ENGLAND JOURNAL OF MEDICINE, 2007, 357 (22) :2262-2268

[8] The Normal Impact of Age and Gender on Right Heart Structure and Function [J].

Henein, Michael ;

Waldenstrom, Anders ;

Morner, Stellan ;

Lindqvist, Per .

ECHOCARDIOGRAPHY-A JOURNAL OF CARDIOVASCULAR ULTRASOUND AND ALLIED TECHNIQUES, 2014, 31 (01) :5-11

[9]

Kent DM, 2008, NEW ENGL J MED, V358, P1519

[10] Heterogeneity of Treatment Effects in an Analysis of Pooled Individual Patient Data From Randomized Trials of Device Closure of Patent Foramen Ovale After Stroke [J].

Kent, David M. ;

Saver, Jeffrey L. ;

Kasner, Scott E. ;

Nelson, Jason ;

Carroll, John D. ;

Chatellier, Gilles ;

Derumeaux, Genevieve ;

Furlan, Anthony J. ;

Herrmann, Howard C. ;

Juni, Peter ;

Kim, Jong S. ;

Koethe, Benjamin ;

Lee, Pil Hyung ;

Lefebvre, Benedicte ;

Mattle, Heinrich P. ;

Meier, Bernhard ;

Reisman, Mark ;

Smalling, Richard W. ;

Soendergaard, Lars ;

Song, Jae-Kwan ;

Mas, Jean-Louis ;

Thaler, David E. .

JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2021, 326 (22) :2277-2286

← 1 2 3 4 →