메뉴 건너뛰기




Volumn 304, Issue 18, 2010, Pages 2019-2027

Automated surveillance to detect postprocedure safety signals of approved cardiovascular devices

Author keywords

[No Author keywords available]

Indexed keywords

ADULT; AGED; ARTICLE; ARTIFICIAL EMBOLISM; AUTOMATION; BARE METAL STENT; CARDIOVASCULAR SURGERY; CLINICAL ASSESSMENT; COHORT ANALYSIS; CONTROLLED STUDY; DEVICE; DRUG ELUTING STENT; FEMALE; HEART INFARCTION; HUMAN; IMPLANT; MAJOR CLINICAL STUDY; MALE; PERCUTANEOUS CORONARY INTERVENTION; POSTOPERATIVE COMPLICATION; POSTOPERATIVE PERIOD; PRIORITY JOURNAL; PROSPECTIVE STUDY; REGISTER; RISK ASSESSMENT; RISK FACTOR; SAFETY; SENSITIVITY ANALYSIS; SURGICAL TECHNIQUE;

EID: 78149345321     PISSN: 00987484     EISSN: 15383598     Source Type: Journal    
DOI: 10.1001/jama.2010.1633     Document Type: Article
Times cited : (55)

References (34)
  • 3
    • 33847723010 scopus 로고    scopus 로고
    • Unanswered questions - Drug-eluting stents and the risk of late thrombosis
    • DOI 10.1056/NEJMp068305
    • Maisel WH. Unanswered questions - drug-eluting stents and the risk of late thrombosis. N Engl J Med. 2007;356(10):981-984. (Pubitemid 46376797)
    • (2007) New England Journal of Medicine , vol.356 , Issue.10 , pp. 981-984
    • Maisel, W.H.1
  • 4
    • 33746931286 scopus 로고    scopus 로고
    • Recalls and safety alerts affecting automated external defibrillators
    • Shah JS, Maisel WH. Recalls and safety alerts affecting automated external defibrillators. JAMA. 2006;296(6):655-660.
    • (2006) JAMA , vol.296 , Issue.6 , pp. 655-660
    • Shah, J.S.1    Maisel, W.H.2
  • 5
    • 34548303246 scopus 로고    scopus 로고
    • The rosiglitazone story - Lessons from an FDA Advisory Committee meeting
    • Rosen CJ. The rosiglitazone story - lessons from an FDA Advisory Committee meeting. N Engl J Med. 2007;357(9):844-846.
    • (2007) N Engl J Med , vol.357 , Issue.9 , pp. 844-846
    • Rosen, C.J.1
  • 6
    • 77950515463 scopus 로고    scopus 로고
    • Modernizing device regulation
    • Garber AM. Modernizing device regulation. N Engl J Med. 2010;362(13):1161-1163.
    • (2010) N Engl J Med , vol.362 , Issue.13 , pp. 1161-1163
    • Garber, A.M.1
  • 8
    • 64949126364 scopus 로고    scopus 로고
    • INTERMACS: Interval analysis of registry data
    • Holman WL, Pae WE, Teutenberg JJ, et al. INTERMACS: interval analysis of registry data. J Am Coll Surg. 2009;208(5):755-762.
    • (2009) J Am Coll Surg , vol.208 , Issue.5 , pp. 755-762
    • Holman, W.L.1    Pae, W.E.2    Teutenberg, J.J.3
  • 9
    • 0035875785 scopus 로고    scopus 로고
    • The American College of Cardiology-National Cardiovascular Data Registry (ACC-NCDR): Building a national clinical data repository
    • Brindis RG, Fitzgerald S, Anderson HV, Shaw RE, Weintraub WS, Williams JF. The American College of Cardiology-National Cardiovascular Data Registry (ACC-NCDR): building a national clinical data repository. J Am Coll Cardiol. 2001;37(8):2240-2245.
    • (2001) J Am Coll Cardiol , vol.37 , Issue.8 , pp. 2240-2245
    • Brindis, R.G.1    Fitzgerald, S.2    Anderson, H.V.3    Shaw, R.E.4    Weintraub, W.S.5    Williams, J.F.6
  • 10
    • 70350505796 scopus 로고    scopus 로고
    • Clinical characteristics and in-hospital outcome of patients with end-stage renal disease on dialysis referred for implantable cardioverter-defibrillator implantation
    • National Cardiovascular Data Registry
    • Aggarwal A, Wang Y, Rumsfeld JS, Curtis JP, Heidenreich PA; National Cardiovascular Data Registry. Clinical characteristics and in-hospital outcome of patients with end-stage renal disease on dialysis referred for implantable cardioverter-defibrillator implantation. Heart Rhythm. 2009;6(11):1565-1571.
    • (2009) Heart Rhythm , vol.6 , Issue.11 , pp. 1565-1571
    • Aggarwal, A.1    Wang, Y.2    Rumsfeld, J.S.3    Curtis, J.P.4    Heidenreich, P.A.5
  • 11
    • 33644597163 scopus 로고    scopus 로고
    • The National ICD Registry: Now and into the future
    • Hammill S, Phurrough S, Brindis R. The National ICD Registry: now and into the future. Heart Rhythm. 2006;3(4):470-473.
    • (2006) Heart Rhythm , vol.3 , Issue.4 , pp. 470-473
    • Hammill, S.1    Phurrough, S.2    Brindis, R.3
  • 12
    • 56149126904 scopus 로고    scopus 로고
    • Rare adverse event monitoring of medical devices with the use of an automated surveillance tool
    • Matheny ME, Arora N, Ohno-Machado L, Resnic FS. Rare adverse event monitoring of medical devices with the use of an automated surveillance tool. AMIA Annu Symp Proc. 2007:518-522.
    • (2007) AMIA Annu Symp Proc , pp. 518-522
    • Matheny, M.E.1    Arora, N.2    Ohno-Machado, L.3    Resnic, F.S.4
  • 13
    • 56549120398 scopus 로고    scopus 로고
    • Long-term clinical outcomes after drug-eluting and bare-metal stenting in Massachusetts
    • Mauri L, Silbaugh TS, Wolf RE, et al. Long-term clinical outcomes after drug-eluting and bare-metal stenting in Massachusetts. Circulation. 2008;118(18):1817-1827.
    • (2008) Circulation , vol.118 , Issue.18 , pp. 1817-1827
    • Mauri, L.1    Silbaugh, T.S.2    Wolf, R.E.3
  • 15
    • 52649151888 scopus 로고    scopus 로고
    • Drug-eluting or bare-metal stents for acute myocardial infarction
    • Mauri L, Silbaugh TS, Garg P, et al. Drug-eluting or bare-metal stents for acute myocardial infarction. N Engl J Med. 2008;359(13):1330-1342.
    • (2008) N Engl J Med , vol.359 , Issue.13 , pp. 1330-1342
    • Mauri, L.1    Silbaugh, T.S.2    Garg, P.3
  • 16
    • 78149290391 scopus 로고    scopus 로고
    • Web site. Accessed January 4, 2010
    • Description of NCDR CathPCI Registry. National Cardiovascular Data Registry Web site. https://www.ncdr.com/webncdr/DefaultCathPCI.aspx. 2010. Accessed January 4, 2010.
    • (2010) Description of NCDR CathPCI Registry
  • 17
    • 3242684955 scopus 로고    scopus 로고
    • Exploration of a Bayesian updating methodology to monitor the safety of interventional cardiovascular procedures
    • DOI 10.1177/0272989X04267012
    • Resnic FS, Zou KH, Do DV, Apostolakis G, Ohno-Machado L. Exploration of a Bayesian updating methodology to monitor the safety of interventional cardiovascular procedures. Med Decis Making. 2004;24(4):399-407. (Pubitemid 38955765)
    • (2004) Medical Decision Making , vol.24 , Issue.4 , pp. 399-407
    • Resnic, F.S.1    Zou, K.H.2    Do, D.V.3    Apostolakis, G.4    Ohno-Machado, L.5
  • 19
    • 36849040670 scopus 로고    scopus 로고
    • Risk-adjusted sequential probability ratio test control chart methods for monitoring operator and institutional mortality rates in interventional cardiology
    • DOI 10.1016/j.ahj.2007.08.022, PII S0002870307007089
    • Matheny ME, Ohno-Machado L, Resnic FS. Risk-adjusted sequential probability ratio test control chart methods for monitoring operator and institutional mortality rates in interventional cardiology. Am Heart J. 2008;155(1):114-120. (Pubitemid 350234774)
    • (2008) American Heart Journal , vol.155 , Issue.1 , pp. 114-120
    • Matheny, M.E.1    Ohno-Machado, L.2    Resnic, F.S.3
  • 21
    • 60849116685 scopus 로고    scopus 로고
    • Some methods of propensity-score matching had superior performance to others: Results of an empirical investigation and Monte Carlo simulations
    • Austin PC. Some methods of propensity-score matching had superior performance to others: results of an empirical investigation and Monte Carlo simulations. Biom J. 2009;51(1):171-184.
    • (2009) Biom J , vol.51 , Issue.1 , pp. 171-184
    • Austin, P.C.1
  • 22
    • 72149119483 scopus 로고    scopus 로고
    • The relative ability of different propensity score methods to balance measured covariates between treated and untreated subjects in observational studies
    • Austin PC. The relative ability of different propensity score methods to balance measured covariates between treated and untreated subjects in observational studies. Med Decis Making. 2009;29(6):661-677.
    • (2009) Med Decis Making , vol.29 , Issue.6 , pp. 661-677
    • Austin, P.C.1
  • 23
    • 24644477492 scopus 로고    scopus 로고
    • Comparison of a polymer-based paclitaxel-eluting stent with a bare metal stent in patients with complex coronary artery disease
    • Stone GW, Ellis SG, Cannon L, et al . Comparison of a polymer-based paclitaxel-eluting stent with a bare metal stent in patients with complex coronary artery disease. JAMA. 2005;294(10):1215-1223.
    • (2005) JAMA , vol.294 , Issue.10 , pp. 1215-1223
    • Stone, G.W.1    Ellis, S.G.2    Cannon, L.3
  • 24
    • 72249120556 scopus 로고    scopus 로고
    • Frequency and clinical consequences associated with sidebranch occlusion during stent implantation using zotarolimus-eluting and paclitaxel-eluting coronary stents
    • Popma JJ, Mauri L, O'Shaughnessy C, et al. Frequency and clinical consequences associated with sidebranch occlusion during stent implantation using zotarolimus-eluting and paclitaxel-eluting coronary stents. Circ Cardiovasc Interv. 2009;2(2):133-139.
    • (2009) Circ Cardiovasc Interv , vol.2 , Issue.2 , pp. 133-139
    • Popma, J.J.1    Mauri, L.2    O'Shaughnessy, C.3
  • 25
    • 4444370081 scopus 로고    scopus 로고
    • Vascular complications associated with arteriotomy closure devices in patients undergoing percutaneous coronary procedures: A meta-analysis
    • Nikolsky E, Mehran R, Halkin A, et al. Vascular complications associated with arteriotomy closure devices in patients undergoing percutaneous coronary procedures: a meta-analysis. J Am Coll Cardiol. 2004;44(6):1200-1209.
    • (2004) J Am Coll Cardiol , vol.44 , Issue.6 , pp. 1200-1209
    • Nikolsky, E.1    Mehran, R.2    Halkin, A.3
  • 26
    • 0345872125 scopus 로고    scopus 로고
    • Arterial puncture closing devices compared with standard manual compression after cardiac catheterization
    • Koreny M, Riedmüller E, Nikfardjam M, Siostrzonek P, Müllner M. Arterial puncture closing devices compared with standard manual compression after cardiac catheterization. JAMA. 2004;291(3):350-357.
    • (2004) JAMA , vol.291 , Issue.3 , pp. 350-357
    • Koreny, M.1    Riedmüller, E.2    Nikfardjam, M.3    Siostrzonek, P.4    Müllner, M.5
  • 27
    • 33644876256 scopus 로고    scopus 로고
    • Risk of local adverse events following cardiac catheterization by hemostasis device use - Phase II
    • Tavris DR, Dey S, Albrecht-Gallauresi B, et al. Risk of local adverse events following cardiac catheterization by hemostasis device use - phase II. J Invasive Cardiol. 2005;17(12):644-650.
    • (2005) J Invasive Cardiol , vol.17 , Issue.12 , pp. 644-650
    • Tavris, D.R.1    Dey, S.2    Albrecht-Gallauresi, B.3
  • 28
    • 0032860992 scopus 로고    scopus 로고
    • Predictors of complications and learning curve using the Angio-Seal closure device following interventional and diagnostic catheterization
    • Warren BS, Warren SG, Miller SD. Predictors of complications and learning curve using the Angio-Seal closure device following interventional and diagnostic catheterization. Catheter Cardiovasc Interv. 1999;48(2):162-166.
    • (1999) Catheter Cardiovasc Interv , vol.48 , Issue.2 , pp. 162-166
    • Warren, B.S.1    Warren, S.G.2    Miller, S.D.3
  • 30
    • 36849087424 scopus 로고    scopus 로고
    • Antithrombotic strategies in patients with acute coronary syndromes undergoing early invasive management
    • Stone GW, Ware JH, Bertrand ME, et al. Antithrombotic strategies in patients with acute coronary syndromes undergoing early invasive management. JAMA. 2007;298(21):2497-2506.
    • (2007) JAMA , vol.298 , Issue.21 , pp. 2497-2506
    • Stone, G.W.1    Ware, J.H.2    Bertrand, M.E.3
  • 33
    • 47849112565 scopus 로고    scopus 로고
    • Postmarket evaluation of breakthrough technologies
    • Rao SV, Califf RM, Kramer JM, et al. Postmarket evaluation of breakthrough technologies. Am Heart J. 2008;156(2):201-208.
    • (2008) Am Heart J , vol.156 , Issue.2 , pp. 201-208
    • Rao, S.V.1    Califf, R.M.2    Kramer, J.M.3
  • 34
    • 78149349684 scopus 로고    scopus 로고
    • Web site. Accessed May 3, 2010
    • FDA's Sentinel Initiative. US Food and Drug Administration Web site. http://www.fda.gov/Safety/FDAsSentinelInitiative/default.htm. 2010. Accessed May 3, 2010.
    • (2010) FDA's Sentinel Initiative


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.