Managing anticoagulation in patients receiving implantable cardiac devices

Papers of special note have been highlighted as: • of interest; •• of considerable interest

References

• 1 Mond HG, Proclemer A. The 11th world survey of cardiac pacing and implantable cardioverter-defibrillators: calendar year 2009 a World Society of Arrhythmia's project. Pacing Clin. Electrophysiol. 34(8), 1013–1027 (2011).
  MedlineGoogle Scholar
• 2 Nielsen JC, Thomsen PE, Højberg S et al. A comparison of single-lead atrial pacing with dual-chamber pacing in sick sinus syndrome. Eur. Heart J. 32(6), 686–696 (2011).
  MedlineGoogle Scholar
• 3 Bardy GH, Lee KL, Mark DB et al. Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure. N. Engl. J. Med. 352(3), 225–237 (2005).
  Medline CASGoogle Scholar
• 4 Bogale N, Witte K, Priori S et al. The European cardiac resynchronization therapy survey: comparison of outcomes between de novo cardiac resynchronization therapy implantations and upgrades. Eur. J. Heart Fail. 13(9), 974–983 (2011).
  MedlineGoogle Scholar
• 5 Mangrolia N, Nayar V, Pugh PJ. Managing anticoagulation in patients receiving implantable cardiac devices. Future Cardiol. 8(3), 393–411 (2012).
  CASGoogle Scholar
• 6 Sticherling C, Martin F, Birnie D et al. Antithrombotic management in patients undergoing electrophysiological procedures: a European Heart Rhythm Association (EHRA) position document endorsed by the ESC Working Group Thrombosis, Heart Rhythm Society (HRS), and Asia Pacific Heart Rhythm Society (APHRS). Europace 17(8), 1197–1214 (2015). • European Heart Rhythm Association consensus recommendations about antithrombotic management in patients undergoing cardiac devices implantation.
  MedlineGoogle Scholar
• 7 Zaca V, Marcucci R, Parodi G et al. Management of antithrombotic therapy in patients undergoing electrophysiological device surgery. Europace 17(6), 840–854 (2015). • Practical recommendations for the management of antithrombotic therapy in patients undergoing cardiac implantable electronic device surgery.
  MedlineGoogle Scholar
• 8 Reynolds MR, Cohen DJ, Kugelmass AD et al. The frequency and incremental cost of major complications among medicare beneficiaries receiving implantable cardioverter-defibrillators. J. Am. Coll. Cardiol. 47(12), 2493–2497 (2006).
  MedlineGoogle Scholar
• 9 Mahapatra S, Bybee KA, Bunch TJ et al. Incidence and predictors of cardiac perforation after permanent pacemaker placement. Heart Rhythm 2(9), 907–911 (2005).
  MedlineGoogle Scholar
• 10 Wiegand UK, LeJeune D, Boguschewski F et al. Pocket hematoma after pacemaker or implantable cardioverter defibrillator surgery: influence of patient morbidity, operation strategy, and perioperative antiplatelet/anticoagulation therapy. Chest 126(4), 1177–1186 (2004).
  MedlineGoogle Scholar
• 11 Dasgupta A, Montalvo J, Mdendorp S et al. Increased complication rates of cardiac rhythm management devices in ESRD patients. Am. J. Kidney Dis. 49(5), 656–663 (2007).
  MedlineGoogle Scholar
• 12 Birnie DH, Healey JS, Wells GA et al. Pacemaker or defibrillator surgery without interruption of anticoagulation. N. Engl. J. Med. 368(22), 2084–2093 (2013). •• Large randomized control trial comparing the incidence of device pocket hematoma in patients undergoing cardiac device implantation between continuing warfarin treatment or bridging therapy with heparin.
  Medline CASGoogle Scholar
• 13 Ghanbari H, Phard WS, Al-Ameri H et al. Meta-analysis of safety and efficacy of uninterrupted warfarin compared to heparin-based bridging therapy during implantation of cardiac rhythm devices. Am. J. Cardiol. 110(10), 1482–1488 (2012).
  Medline CASGoogle Scholar
• 14 Bernard ML, Shotwell M, Nietert PJ, Gold MR. Meta-analysis of bleeding complications associated with cardiac rhythm device implantation. Circ. Arrhythm. Electrophysiol. 5(3), 468–474 (2012).
  MedlineGoogle Scholar
• 15 Poole JE, Gleva MJ, Mela T et al. Complication rates associated with pacemaker or implantable cardioverter-defibrillator generator replacements and upgrade procedures: results from the REPLACE registry. Circulation 122(16), 1553–1561 (2010).
  MedlineGoogle Scholar
• 16 Lekkerkerker JC, van Nieuwkoop C, Trines SA et al. Risk factors and time delay associated with cardiac device infections: Leiden device registry. Heart 95(9), 715–720 (2009).
  Medline CASGoogle Scholar
• 17 Klug D, Balde M, Pavin D et al. Risk factors related to infections of implanted pacemakers and cardioverter-defibrillators: results of a large prospective study. Circulation 116(12), 1349–1355 (2007).
  MedlineGoogle Scholar
• 18 Carlson MD, Freedman RA, Levine PA. Lead perforation: incidence in registries. Pacing Clin. Electrophysiol. 31(1), 13–15 (2008).
  MedlineGoogle Scholar
• 19 Camm AJ, Lip GYH, De Caterina R et al. 2012 focused update of the ESC guidelines for the management of atrial fibrillation. Eur. Heart J. 33(21), 2719–2747 (2012).
  MedlineGoogle Scholar
• 20 AlTurki A, Proietti R, Birnie DH, Essebag V. Management of antithrombotic therapy during cardiac implantable device surgery. J. Arrhythm. 32(3), 163–169 (2016). •• Recent review article on management of anithrombotic therapy during cardiac device implantation.
  MedlineGoogle Scholar
• 21 CHADSVASC. www.chadsvasc.org.
  Google Scholar
• 22 Poldermans D, Bax JJ, Boersma E et al. Guidelines for pre-operative cardiac risk assessment and perioperative cardiac management in non-cardiac surgery: the Task Force for Preoperative Cardiac Risk Assessment and Perioperative Cardiac Management in Non-cardiac Surgery of the European Society of Cardiology (ESC) and endorsed by the European Society of Anaesthesiology (ESA). Eur. J. Anaesthesiol. 27(2), 92–137 (2010).
  MedlineGoogle Scholar
• 23 Blacker DJ, Wijdicks EF, McClelland RL. Stroke risk in anticoagulated patients with atrial fibrillation: the Atrial Fibrillation Investigators. Stroke 40(4), 1410–1416 (2009).
  MedlineGoogle Scholar
• 24 Weiss P, Soff GA, Halkin H, Seligsohn U. Decline of protein C and S and factors II, VII, IX, X during the initiation of warfarin therapy. Throm. Res. 45(6), 783–790 (1987).
  Medline CASGoogle Scholar
• 25 Cannegieter SC, Rosendaal FR, Briet E. Thromboembolic and bleeding complications in patients with mechanical heart valve prostheses. Circulation 89(2), 635–641 (1994).
  Medline CASGoogle Scholar
• 26 Vahanian A, Alfieri O, Andreotti F et al. ESC Guidelines on the management of valvular heart disease (version 2012). Eur. Heart J. 33(19), 2451–2496 (2012).
  MedlineGoogle Scholar
• 27 Butchart EG, Ionescu A, Payne N, Giddings J, Grunkemeier GL, Fraser AG. A new scoring system to determine thromboembolic risk after heart valve replacement. Circulation 108(1), 68–74 (2003).
  Google Scholar
• 28 Castellucci LA, Cameron C, Gal GL et al. Safety and efficacy outcomes of oral anticoagulants and antiplatelet drugs in the secondary prevention of venous thromboembolism: systematic review and network meta-analysis. BMJ 347, f5133 (2013).
  MedlineGoogle Scholar
• 29 Kearon C, Hirsh J. Management of anticoagulation before and after elective surgery. N. Engl. J. Med. 336(21), 1506–1511 (1997).
  Medline CASGoogle Scholar
• 30 Roy P, Bonello L, Torguson R et al. Temporal relation between clopidogrel cessation and stent thrombosis after drug-eluting stent implantation. Am. J. Cardiol. 103(6), 801–805 (2009).
  Medline CASGoogle Scholar
• 31 Schulz S, Schuster T, Mehilli J et al. Stent thrombosis after drug-eluting stent implantation: incidence, timing, and relation to discontinuation of clopidogrel therapy over a 4-year period. Eur. Heart J. 30(22), 2714–2721 (2009).
  Medline CASGoogle Scholar
• 32 Eisenberg MJ, Richard PR, Libersan D, Filion KB. Safety of short-term discontinuation of antiplatelet therapy in patients with drug-eluting stents. Circulation 119(12), 1634–1642 (2009).
  Medline CASGoogle Scholar
• 33 Sarno G, Lagerqvist B, Fröbert O, Nilsson J et al. Lower risk of stent thrombosis and restenosis with unrestricted use of ‘new-generation’ drug-eluting stents: a report from the nationwide Swedish Coronary Angiography and Angioplasty Registry (SCAAR). Eur. Heart J. 33(5), 606–613 (2012).
  MedlineGoogle Scholar
• 34 Park KW, Kang SH, Velders MA et al. Safety and efficacy of everolimus- versus sirolimus-eluting stents: a systematic review and meta-analysis of 11 randomized trials. Am. Heart J. 165(2), 241–250 (2013).
  Medline CASGoogle Scholar
• 35 Palmerini T, Biondi-Zoccai G, Della Riva D et al. Stent thrombosis with drug-eluting and bare-metal stents: evidence from a comprehensive network meta-analysis. Lancet 379(9824), 1393–1402 (2012).
  Medline CASGoogle Scholar
• 36 Ferreira-Gonzalez I, Marsal JR, Ribera A et al. Double antiplatelet therapy after drug-eluting stent implantation: risk associated with discontinuation within the first year. J. Am. Coll. Cardiol. 60(15), 1333–1339 (2012).
  Medline CASGoogle Scholar
• 37 Mehran R, Baber U, Steg PG et al. Cessation of dual antiplatelet treatment and cardiac events after percutaneous coronary intervention (PARIS): 2year results from a prospective observational study. Lancet 382(9906), 1714–1722 (2013).
  MedlineGoogle Scholar
• 38 Scheller B. Antithrombocytic therapy and PCI. Duration of therapy after DCB/stents/scaffolds. Herz 39(7), 819–821 (2014).
  Medline CASGoogle Scholar
• 39 Windecker S, Kolh P, Alfonso F et al. 2014 ESC/EACTS Guidelines on myocardial revascularization: the task force on myocardial revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS) Developed with the special contribution of the European Association of Percutaneous Cardiovascular Interventions (EAPCI). Eur. Heart J. 35(37), 2541–2619 (2014).
  MedlineGoogle Scholar
• 40 Douketis JD, Spyropoulos AC, Spencer FA et al. Perioperative management of antithrombotic therapy: Antithrombotic Therapy and Prevention of Thrombosis, 9th Edition: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest 141(2), 326–350 (2012).
  Google Scholar
• 41 Douketis JD, Berger PB, Dunn AS et al. The perioperative management of antithrombotic therapy: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest 133(6), 299–339 (2008).
  Google Scholar
• 42 Robinson M, Healey JS, Eikelboom J et al. Postoperative low-molecular-weight heparin bridging is associated with an increase in wound hematoma following surgery for pacemakers and implantable defibrillators. Pacing Clin. Electrophysiol. 32(3), 378–382 (2009).
  MedlineGoogle Scholar
• 43 Tolosana JM, Berne P, Mont L et al. Preparation for pacemaker or implantable cardiac defibrillator implants in patients with high risk of thrombo-embolic events: oral anticoagulation or bridging with intravenous heparin? A prospective randomized trial. Eur. Heart J. 30(15), 1880–1884 (2009).
  MedlineGoogle Scholar
• 44 Cheng A, Nazarian S, Brinker JA et al. Continuation of warfarin during pacemaker or implantable cardioverter-defibrillator implantation: a randomized clinical trial. Heart Rhythm 8(4), 536–540 (2011).
  MedlineGoogle Scholar
• 45 Sant'anna RT, Leiria TL, Nascimento T et al. Meta-analysis of continuous oral anticoagulants versus heparin bridging in patients undergoing CIED surgery: reappraisal after the BRUISE study. Pacing Clin. Electrophysiol. 38(4), 417–423 (2015).
  MedlineGoogle Scholar
• 46 Yang X, Wang Z, Zhang Yet, Yin X, Hou Y. The safety and efficacy of antithrombotic therapy in patients undergoing cardiac rhythm device implantation: a meta-analysis. Europace 17(7), 1076–1084 (2015). • Largest meta analysis assessing safety and efficacy of antithrombotic therapy in patients undergoing cardiac device implantation.
  MedlineGoogle Scholar
• 47 Siegal D, Yudin J, Kaatz S, Douketis JD, Lim W, Spyropoulos AC. Periprocedual heparin bridging in patients receiving vitamin K antagonists: systematic review and meta-analysis of bleeding and thromboembolic rates. Circulation 126(13), 1630–1639 (2012).
  Medline CASGoogle Scholar
• 48 Proietti R, Porto I, Levi M et al. Risk of pocket haematoma in patients on chronic anticoagulation with warfarin undergoing electrophysiological device implantation: a comparison of different peri-operative management strategies. Eur. Rev. Med. Pharmacol. Sci. 19(8), 1461–1479 (2015).
  Medline CASGoogle Scholar
• 49 Feng L, Li Y, Li J, Yu B. Oral anticoagulation continuation compared with heparin bridging therapy among high risk patients undergoing implantation of cardiac rhythm devices. Thromb. Haemost. 108(6), 1124–1131 (2012).
  MedlineGoogle Scholar
• 50 Douketis JD, Spyropoulos AC, Kaatz S et al. Perioperative bridging anticoagulation in patients with atrial fibrillation. N. Engl. J. Med. 373(9), 823–833 (2015).
  Medline CASGoogle Scholar
• 51 Coyle D, Coyle K, Essebag V et al. Cost effectiveness of continued-warfarin versus heparin-bridging therapy during pacemaker and defibrillator surgery. J. Am. Coll. Cardiol. 65(9), 957–959 (2015).
  MedlineGoogle Scholar
• 52 Harder S, Graff J. Novel oral anticoagulants: clinical pharmacology, indications and practical considerations. Eur. J. Clin. Pharmacol. 69(9), 1617–1633 (2013).
  Medline CASGoogle Scholar
• 53 Heidbuchel H, Verhamme P, Alings M et al. Updated European Heart Rhythm Association Practical Guide on the use of non-vitamin K antagonist anticoagulants in patients with non-valvular atrial fibrillation. Europace 17(10), 1467–507 (2015).
  MedlineGoogle Scholar
• 54 Healey JS, Eikelboom J, Douketis J et al. Periprocedural bleeding and thromboembolic events with dabigatran compared with warfarin: results from the randomized evaluation of long-term anticoagulation therapy (RE-LY) randomized trial. Circulation 126(3), 343–348 (2012). •• Randomized trial comparing the periprocedural bleeding risk of patients treated with dabigatran and warfarin.
  Medline CASGoogle Scholar
• 55 Rowley CP, Bernard ML, Brabham WW et al. Safety of continuous anticoagulation with dabigatran during implantation of cardiac rhythm devices. Am. J. Cardiol. 111(8), 1165–1168 (2013).
  Medline CASGoogle Scholar
• 56 Jennings JM, Robichaux R, Mcelderry HT et al. Cardiovascular implantable electronic device implantation with uninterrupted dabigatran: comparison to uninterrupted warfarin. J. Cardiovasc. Electrophysiol. 24(10), 1125–1129 (2013). • Randomized trial comparing the periprocedural bleeding in patients treated with uninterrupted dabigatran versus interrupted dabigatran versus uninterrupted warfarin.
  MedlineGoogle Scholar
• 57 Kosiuk J, Koutalas E, Doering M et al. Treatment with novel oral anticoagulants in a real-world cohort of patients undergoing cardiac rhythm device implantations. Europace 16(7), 1028–1032 (2014).
  MedlineGoogle Scholar
• 58 Shivanshu M, Muthusamy P, Mowers KL et al. Safety of anticoagulation with uninterrupted warfarin vs. interrupted dabigatran in patients requiring an implantable cardiac device. Cardiovasc. Diagn. Ther. 6(1), 3–9 (2016).
  MedlineGoogle Scholar
• 59 Nascimento T, Birnie DH, Healey JS et al. Managing novel oral anticoagulants in patients with atrial fibrillation undergoing device surgery: Canadian survey. Can. J. Cardiol. 30(2), 231–236 (2014).
  MedlineGoogle Scholar
• 60 Tompkins C, Cheng A, Dalal D et al. Dual antiplatelet therapy and heparin “bridging” significantly increase the risk of bleeding complications after pacemaker or implantable cardioverter-defibrillator device implantation. J. Am. Coll. Cardiol. 55(21), 2376–2382 (2010).
  MedlineGoogle Scholar
• 61 Cano O, Osca J, Sancho-Tello MJ, Olague J, Castro JE, Salvador A. Morbidity associated with three different antiplatelet regimens in patients undergoing implantation of cardiac rhythm management devices. Europace 13(3), 395–401 (2011).
  MedlineGoogle Scholar
• 62 Said SM, Esperer HD, Hahn J et al. Influence of oral antiplatelet therapy on hemorrhagic complications of pacemaker implantation. Clin. Res. Cardiol. 102(5), 345–349 (2013).
  Medline CASGoogle Scholar
• 63 Dai Y, Chen KP, Hua W, Zhang JT, Zhang S. Dual antiplatelet therapy increases pocket hematoma complications in Chinese patients with pacemaker implantation. J. Geriatr. Cardiol. 12(4), 383–387 (2015). •• Prospective study assessing the prevalence of the bleeding complications in pacemaker implanted patients receiving different antiplatelet regimens.
  MedlineGoogle Scholar
• 64 Przybylski A, Derejko P, Kwasniewski W et al. Bleeding complications after pacemaker or cardioverter-defibrillator implantation in patients receiving dual antiplatelet therapy. Neth. Heart J. 18(5), 230–235 (2010).
  Medline CASGoogle Scholar
• 65 Lip GY, Windecker S, Huber K et al. Management of antithrombotic therapy in atrial fibrillation patients presenting with acute coronary syndrome and/or undergoing percutaneous coronary or valve interventions: a joint consensus document of the European Society of Cardiology Working Group on Thrombosis, European Heart Rhythm Association (EHRA), European Association of Percutaneous Cardiovascular Interventions (EAPCI) and European Association of Acute Cardiac Care (ACCA) endorsed by the Heart Rhythm Society (HRS) and Asia-Pacific Heart Rhythm Society (APHRS). Eur. Heart J. 35(45), 3155–3179 (2014).
  Medline CASGoogle Scholar
• 66 Calkins S, Willems S, Gerstenfeld EP et al. Uninterrupted dabigatran versus warfarin for ablation in Atrial Fibrillation. N. Engl. J. Med. 376(17), 1627–1636 (2017).
  Medline CASGoogle Scholar