Patent foramen ovale closure and migraine: science and sensibility

References

• Lechat P, Mas JL, Lascault G et al. Prevalence of patent foramen ovale in patients with stroke. N. Engl. J. Med.318, 1148–1152 (1988).
   PubMed Web of Science ®Google Scholar
• Adams HP. Patent foramen ovale: paradoxical embolism and paradoxical data. Mayo Clin. Proc.79, 15–20 (2004).
   PubMed Web of Science ®Google Scholar
• Dowson AJ, Mullen M, Peatfield R et al. Migraine Intervention with STARFlex Technology trial: a prospective, multicentre, double-blind, sham-controlled trial to evaluate the effectiveness of patent foramen ovale closure with STARFlex septal repair implant to resolve refractory migraine headache. Circulation117, 1397–1404 (2008).
   PubMed Web of Science ®Google Scholar
• Gupta VK. Closure of PFO: science, quasi-science, or empiricism. Cardiology113, 108–110 (2009).
   PubMed Web of Science ®Google Scholar
• Schuchlenz HW, Weihs W, Horner S, Quehenberger F. The association between the diameter of a patent foramen ovale and the risk of embolic cerebrovascular events. Am. J. Med.109, 456–462 (2000).
   PubMed Web of Science ®Google Scholar
• Serena J, Marti-Fabregas J, Santamarina E et al.; CODICIA (Right-to-Left Shunt in Cryptogenic Stroke) Study; Stroke Project of the Cerebrovascular Diseases Study Group, Spanish Society of Neurology. Recurrent stroke and massive right-to-left shunt. Results from the prospective Spanish Multicenter (CODICIA) Study. Stroke39, 3131–3136 (2008).
   PubMed Web of Science ®Google Scholar
• Mas JL, Arquizan C, Lamy C et al.; Patent Foramen Ovale and Atrial Septal Aneurysm Study Group. Recurrent cerebrovascular events associated with patent foramen ovale, atrial septal aneurysm, or both. N. Engl. J. Med.345, 1740–1746 (2001).
   PubMed Web of Science ®Google Scholar
• Homma S, Sacco RL, Di Tullio MR, Sciacca RR, Mohr JP. PFO in Cryptogenic Stroke (PICSS) Investigators. Effect of medical treatment in stroke patients with patent foramen ovale: patent foramen ovale in Cryptogenic Stroke Study. Circulation105, 2625–2631 (2002).
   PubMed Web of Science ®Google Scholar
• Di Tullio MR, Sacco RL, Sciacca RR, Jin Z, Homma S. Patent foramen ovale and the risk of ischemic stroke in a multiethnic population. J. Am. Coll. Cardiol.49, 797–802 (2007).
   PubMed Web of Science ®Google Scholar
• Kutty S, Brown K, Qureshi AM, Latson LA. Maximal potential patent foramen diameter does not correlate with type or frequency of neurologic event prior to closure. Cardiology113, 111–115 (2009).
   PubMed Web of Science ®Google Scholar
• Meier B, Lock JE. Contemporary management of patent foramen ovale. Circulation.107, 5–9 (2003).
   PubMed Web of Science ®Google Scholar
• Berdat PA, Chatterjee T, Pfammatter JP, Windecker S, Meier B, Carrel T. Surgical management of complications after transcatheter closure of an atrial septal defect or patent foramen ovale. J. Thorac. Cardiovasc. Surg.120, 1034–1039 (2000).
   PubMed Web of Science ®Google Scholar
• Stöllberger C, Finsterer J, Krexener E, Schneider B. Stroke and peripheral embolism from an Amplatzer septal occluder 5 years after implantation. J. Neurol.255, 1270–1271 (2008).
   PubMed Web of Science ®Google Scholar
• Holmes DR Jr, Cabalka A. Was your mother right – do we always need to close the door? Circulation106, 1034–1036 (2002).
   PubMed Web of Science ®Google Scholar
• Grotemeyer KH, Scharafinski HW, Schlake HP, Husstedt IW. Acetylsalicylic acid vs. metorpolol in migraine prophylaxis – a double-blind crossover study. Headache30, 639–641 (1990).
   PubMed Web of Science ®Google Scholar
• Gupta VK. CSD, BBB and MMP-9 elevations: animal experiments versus clinical phenomena in migraine. Exp. Rev. Neurother.9, 1595–1614 (2009).
   PubMed Web of Science ®Google Scholar
• Schwedt TJ, Demaerscalk BM, Dodick DW. Patent foramen ovale and migraine: a quantitative systemic review. Cephalalgia28, 531–540 (2008).
   PubMed Web of Science ®Google Scholar
• Carroll JD. Migraine intervention with STARFlex technology trial. A controversial trial of migraine and patent foramen ovale closure. Circulation117, 1358–1360 (2008).
   PubMed Web of Science ®Google Scholar
• Wilmshurst P. The effect of persistent foramen ovale closure on migraine remains an enigma. J. Am. Coll. Cardiol. Interv.2, 114–115 (2009).
   Web of Science ®Google Scholar
• Messe SR, Kasner SE. Is closure recommended for patent foramen ovale and cryptogenic stroke? Patent foramen ovale in cryptogenic stroke: not to close. Circulation118, 1999–2004 (2008).
   PubMed Web of Science ®Google Scholar
• Vigna C, Marchese N, Inchingolo V et al. Improvement of migraine after patent foramen ovale percutaneous closure in patients with subclinical brain lesions: a case–control study. JACC. Cardiovasc. Interv.2, 107–113 (2009).
   PubMed Web of Science ®Google Scholar
• On the falsification of ideas. Lancet340, 344–345 (1992).
   PubMed Web of Science ®Google Scholar
• Gornall J. Medical research: a very public break-up. BMJ340, 180–183 (2010).
   Web of Science ®Google Scholar
• Feinstein AR. Clinical judgment revisited: the distractions of quantitative models. Ann. Intern. Med.120, 799–805 (1994).
   PubMed Web of Science ®Google Scholar
• Gupta VK. Magnesium therapy for migraine: do we need more trials or more reflection? Headache44, 445–446 (2004).
   PubMed Web of Science ®Google Scholar
• Gupta VK. Does magnesium supplementation have any role in acute myocardial infarction? No. Cardiovasc. Drugs. Ther.10, 303–305 (1996).
   PubMed Web of Science ®Google Scholar
• Gupta VK. Botulinum toxin: a treatment for migraine? A systematic review. Pain Med.7, 386–394 (2006).
   PubMed Web of Science ®Google Scholar
• Gupta VK. Interatrial shunt associated migraine: serendipity, empiricism, hope, or hype? Stroke37, 2212 (2006).
   PubMed Web of Science ®Google Scholar
• Gupta VK. PFO/ASD closure and migraine: searching the rationale for the procedure. J. Am. Coll. Cardiol.46, 737–738 (2005).
   PubMed Web of Science ®Google Scholar
• Horton RC, Kendall MJ. Clinical pharmacology and therapeutics. Postgrad. Med. J.67, 1042–1054 (1991).
   PubMed Web of Science ®Google Scholar
• Kaul S, Diamond GA. Trial and error. How to avoid commonly encountered limitations of published clinical trials. J. Am. Coll. Cardiol.55, 415–427 (2010).
   PubMed Web of Science ®Google Scholar
• Hellman S, Hellman DS. Of mice but not men – problems of the randomized clinical trial. N. Engl. J. Med.324, 1585–1589 (1991).
   PubMed Web of Science ®Google Scholar
• Passamani E. Clinical trials – are they ethical? N. Engl. J. Med.324, 1589–1592 (1991).
   PubMed Web of Science ®Google Scholar
• Hellman S, Hellman DS. Randomized clinical trials. N. Engl. J. Med.325, 1515 (1991).
   Google Scholar
• Popper K. Unended Quest. Fontana/Collins, London, UK (1973).
   Google Scholar
• Bhindi R, Ruparelia N, Newton J, Testa L, Ormerod OJ. Acute worsening in migraine symptoms following PFO closure: a matter of fact? Int. J. Cardiol. DOI: 10.1016/j.ijcard.2009.02.027 (2009) (Epub ahead of print).
   Google Scholar
• Yankovsky AE, Kuritzky A. Transformation into daily migraine with aura following transcutaneous atrial septal defect closure. Headache43, 496–498 (2003).
   PubMed Web of Science ®Google Scholar
• Rigatelli G, Cardaioli P, Dell’Avvocata F, Braggion G, Giordan M, Chinaglia M. Early post-procedural migraine attack predicts migraine resolution after patent foramen ovale transcatheter closure. Minerva Cardioangiol.56, 461–465 (2008).
   PubMedGoogle Scholar
• Wahl A, Praz F, Findling O et al. Percutaneous closure of patent foramen ovale for migraine headaches refractory to medical treatment. Catheter. Cardiovasc. Interv.74, 124–120 (2009).
   PubMed Web of Science ®Google Scholar
• Chessa M, Colombo C, Butera G et al. Is it too early to recommend patent foramen ovale closure for all patients who suffer from migraine? A single-centre study. J. Cardiovasc Med. (Hagerstown)10, 401–405 (2009).
   PubMed Web of Science ®Google Scholar
• Gupta VK. A clinical review of the adaptive role of vasopressin in migraine. Cephalalgia17, 561–569 (1997).
   PubMed Web of Science ®Google Scholar
• Brenner BM, Ballermann BJ, Gunning ME, Zeidel ML. Diverse biological actions of atrial natriuretic peptide. Physiol. Rev.70, 665–699 (1990).
   PubMed Web of Science ®Google Scholar
• Kovacs GL. The role of atrial natriuretic peptide in alcohol withdrawal: a peripheral indicator and central modulator? Eur. J. Pharmacol.405, 103–112 (2000).
   PubMed Web of Science ®Google Scholar
• Gupta VK. Migrainous scintillating scotoma and headache is ocular in origin: a new hypothesis. Med. Hypotheses66, 454–460 (2006).
   PubMed Web of Science ®Google Scholar
• Gupta VK. Closure of atrial septal defect and migraine. Headache44, 291–292 (2004).
   PubMed Web of Science ®Google Scholar
• Gupta VK. A hypothesis for the migraine headache syndrome. Spirit of Enterprise. The 1990 Rolex Awards. Buri International Berne, Switzerland, 155 (1990).
   Google Scholar
• Johnson AG. Surgery as a placebo. Lancet344, 1140–1142 (1994).
   PubMed Web of Science ®Google Scholar
• Kern MJ, King III SB. Cardiac catheterization, cardiac angiography, and coronary blood flow and pressure measurements. In: Hurst’s The Heart. Fuster V, O’Rourke RA, Walsh RA, Poole-Wilson P (Eds). McGraw Hill, NY, USA, 467–524 (2008).
   Google Scholar
• Gupta VK. Adaptive Mechanisms in Migraine: A Comprehensive Synthesis in Evolution. Breaking The Migraine Code. Nova Science Publishers, Inc., NY, USA (2009).
   Google Scholar
• Skrabanek P. Demarcation of the absurd. Lancet1(8487), 960–961 (1986).
   PubMed Web of Science ®Google Scholar
• Gupta VK. ASD closure for migraine: is there a scientific basis? Eur. Heart. J.26, 1446 (2005).
   PubMed Web of Science ®Google Scholar
• Herman J. Experiment and observation. Lancet344, 1209–1211 (1994).
   PubMed Web of Science ®Google Scholar
• Gupta VK. β-blockers, hypertension, and RCTs: science and sensibility. J. Am. Coll. Cardiol.53, 2102–2103 (2009).
   PubMed Web of Science ®Google Scholar
• Li J, Zhang Q, Zhang M, Egger M. Intravenous magnesium for acute myocardial infarction. Cochrane Database Syst. Rev.2, CD002755 (2007).
   PubMedGoogle Scholar
• Stoeckle JD. Do patients want to be informed? Do they want to decide? J. Gen. Intern. Med.10, 643–644 (1995).
   PubMed Web of Science ®Google Scholar
• Edwards SJL, Lilford RJ, Braunholtz DA, Jackson JC, Hewison J, Thornton J. Ethical issues in the design and conduct of randomized controlled trials. Health Technology Assessment2, 15 (1998).
   Google Scholar
• Bulger RE, Heitman E, Reiser ST. The Ethical Dimensions of Biological Sciences. Cambridge University Press, Cambridge, UK (1993).
   Google Scholar
• Cassileth BR, Zupkis RV, Sutton-Smith K, March V. Informed consent – why are its goals imperfectly realized. N. Engl. J. Med.302, 896–900 (1980).
   PubMed Web of Science ®Google Scholar
• Vandenbroucke JP. Medical journals and the shaping of medical knowledge. Lancet352, 2001–2006 (1998).
   PubMed Web of Science ®Google Scholar
• Davidson RA. Source of funding and outcome of clinical trials. J. Gen. Intern. Med.1, 155–158 (1986).
   PubMed Web of Science ®Google Scholar
• Gillett R, Harrow J. Is medical research well served by peer review? BMJ.306, 1672–1675 (1993).
   PubMed Web of Science ®Google Scholar
• Silverman WA, Altman DG. Patients’ preferences and randomized trials. Lancet347, 171–174 (1996).
   PubMed Web of Science ®Google Scholar
• Martyn C. Not quite as random as I pretended. Lancet347, 70 (1996).
   PubMed Web of Science ®Google Scholar
• Kassirer JP. The frustrations of scientific misconduct. N. Engl. J. Med.328, 1634–1636 (1993).
   PubMed Web of Science ®Google Scholar
• Skrabanek P. The Ethics and Politics of Human Experimentation. Cambridge University Press, Cambridge, UK (1993).
   Google Scholar
• Blau JN. Evidence-based medicine. Lancet346, 1300 (1995).
   PubMed Web of Science ®Google Scholar
• Hara H, Virmani R, Ladich E et al. Patent foramen ovale: current pathology, pathophysiology, and clinical status. J. Am. Coll. Cardiol.46, 1768–1776 (2005).
   PubMed Web of Science ®Google Scholar
• Blau JN, Thavapalan M. Preventing migraine: a study of precipitating factors. Headache28, 481–483 (1988).
   PubMed Web of Science ®Google Scholar
• Campbell JK. Manifestations of migraine. Neurol. Clin.8, 841–855 (1990).
   PubMed Web of Science ®Google Scholar
• Kimball RW, Friedman AP, Vallejo E. Effect of serotonin in migraine patients. Neurology10, 107–111 (1960).
   PubMed Web of Science ®Google Scholar
• Hopf HC, Johnson EA, Gutmann L. Protective effect of serotonin on migraine attacks. Neurology42, 1419 (1992).
   PubMed Web of Science ®Google Scholar
• Gupta V, Yesilbursa D, Huang WY et al. Patent foramen ovale in a large population of ischemic stroke patients: diagnosis, age distribution, gender, and race. Echocardiography25, 217–227 (2008).
   PubMed Web of Science ®Google Scholar
• Blau JN. Migraine: theories of pathogenesis. Lancet339, 1202–1207 (1992).
   PubMed Web of Science ®Google Scholar
• Joseph R, Steiner TJ, Schultz LU, Clifford Rose F. Platelet activity and selective β-blockade in migraine prophylaxis. Stroke19, 704–708 (1998).
   Google Scholar
• Grotemeyer KH, Scharafinski H-W, Schlake H-P, Husstedt IW. Acetylsalicylic acid vs. metoprolol in migraine prophylaxis – a double-blind cross-over study. Headache30, 639–641 (1990).
   PubMed Web of Science ®Google Scholar
• Brandes JL. The influence of estrogen on migraine: a systematic review. JAMA295, 1824–1830 (2006).
   PubMed Web of Science ®Google Scholar
• Finocchi C, Del Sette M, Angeli S, Rizzi D, Gandolfo C. Cluster headache and right-to-left shunt on contrast transcranial Doppler. A case–control study. Neurology63, 1309–1310 (2004).
   PubMed Web of Science ®Google Scholar
• Ranson R, Igarashi H, MacGregor EA, Wilkinson M. The similarities and differences of migraine with aura and migraine without aura: a preliminary study. Cephalalgia11, 189–192 (1991).
   PubMed Web of Science ®Google Scholar
• Rasmussen BK, Jensen R, Olesen J. A population-based analysis of the diagnostic criteria of the International Headache Society. Cephalalgia11, 129–134 (1991).
   PubMed Web of Science ®Google Scholar
• Azarbal B, Tobis J, Suh W, Chan V, Dao C, Gaster R. Association of interatrial shunts and migraine headaches. Impact of transcatheter closure. J. Am. Coll. Cardiol.45, 489–492 (2005).
   PubMed Web of Science ®Google Scholar
• Milhaud D, Bogousslavsky J, van Melle G, Liot P. Ischemic stroke and active migraine. Neurology.57, 1805–1811 (2001).
   PubMed Web of Science ®Google Scholar
• Broderick JP, Swanson JW. Migraine-related strokes. Clinical profile and prognosis in 20 patients. Arch. Neurol.44, 868–871 (1987).
   PubMed Web of Science ®Google Scholar
• Hellman S. Editorial: randomised clinical trials and the doctor–patient relationship. An ethical dilemma. Cancer Clinical Trials2, 189–193 (1979).
   Google Scholar
• Charlton BG. Restoring the balance: evidence-based medicine put in its place. J. Eval. Clin. Pract.3, 87–98 (1997).
   PubMedGoogle Scholar
• Feinstein AR, Horwitz RJ. Problems in the ‘evidence’ of ‘evidence-based medicine’. Am. J. Med.103, 529–535 (1997).
   PubMed Web of Science ®Google Scholar
• Polychronis A, Miles A, Bentley P. Evidence-based medicine: reference? Dogma? Neologism? New orthodoxy? J. Eval. Clin. Pract.2, 1–3 (1996).
   PubMedGoogle Scholar
• Polychronis A, Miles A, Bentley P. The protagonists of ‘evidence-based medicine’: arrogant, seductive and controversial. J. Eval. Clin. Pract.2, 9–12 (1996).
   PubMedGoogle Scholar
• Sleigh JW. Evidence-based medicine and Kurt Godel. Lancet346, 1172 (1995).
   PubMed Web of Science ®Google Scholar
• Sleigh JW. Logical limits of randomized controlled trials. J. Eval. Clin. Pract.3, 145–148 (1997).
   PubMedGoogle Scholar
• Shahar E. A Popperian perspective of the term ‘evidence-based medicine’. J. Eval. Clin. Pract.3, 109–116 (1997).
   PubMedGoogle Scholar
• Tonelli MR. The philosophical limits of evidence-based medicine. Acad. Med.73, 1234–1240 (1998).
   PubMed Web of Science ®Google Scholar
• Evered D, Lazar P. Misconduct in medical research. Lancet345, 1161–1162 (1995)
   PubMed Web of Science ®Google Scholar
• Pickering WG. Does medical treatment mean patrient benefit? Lancet347, 379–380 (1996).
   PubMed Web of Science ®Google Scholar
• Flaws, hype, and critical assessment. Lancet342, 127 (1993).
   Web of Science ®Google Scholar
• LaPorte RE, Hibbitts B. Rights, wrongs, and journals in the age of cybespace. BMJ313, 1609–1611 (1996).
   PubMed Web of Science ®Google Scholar
• Horrobin DF. Peer review of grant applications: a harbinger for mediocrity in clinical research? Lancet348, 1293–1295 (1996).
   PubMed Web of Science ®Google Scholar
• Riggs JE. Priority, rivalry, and peer review. J. Child. Neurol.10, 255–256 (1995).
   PubMed Web of Science ®Google Scholar
• Goldbeck-Wood S. What makes a good reviewer of manuscripts? BMJ316, 86 (1998).
   PubMed Web of Science ®Google Scholar
• Hodgkin P. Medicine, postmodernism, and the end of certainty. BMJ313, 1568–1569 (1996).
   PubMed Web of Science ®Google Scholar
• Desforges JF. My life at the journal, 1961–1993. N. Engl. J. Med.329, 1038–1039 (1993).
   PubMed Web of Science ®Google Scholar
• Lu Z, Su J. Clinical data management: current status, challenges, and future directions from industry perspectives. Open Access J. Clin. Trials2, 93–105 (2010).
   Google Scholar
• Hagen PT, Scholz DG, Edwards DW. Incidence and size of patent foramen ovale during the first 10 decades of life: an autopsy study of 965 normal hearts. Mayo Clin. Proc.59, 17–20 (1984).
   PubMed Web of Science ®Google Scholar
• Carrel A. Man, The Unknown. Hamish Hamilton Ltd, London, UK (1959).
   Google Scholar
• Meier B, Lock JE. Contemporary management of patent foramen ovale. Circulation107, 5–9 (2003).
   PubMed Web of Science ®Google Scholar
• Tzourio C, El Amrani M, Robert L, Alpérovitch A. Serum elastase activity is elevated in migraine. Ann. Neurol.47, 648–651 (2000).
   PubMed Web of Science ®Google Scholar
• Cohnheim J. Thrombose and Embolie: Vorlesung über Allgemeine Pathologie. Hirschhwald, Berlin, Germany (1877).
   Google Scholar
• Dodick DW. Patent foramen ovale prevention. The subject is still open. JACC Cardiovasc. Interv.3, 288–289 (2010).
   PubMed Web of Science ®Google Scholar
• Kurtzke JF, Houff SA. The slippery slope in medicine. Neurology44, 1775–1776 (1994).
   PubMed Web of Science ®Google Scholar
• Burton M. Science and Contemporary Society. Crosson FJ (Ed.). University of Notre Dame Press, IN, USA (1967).
   Google Scholar