Advertisement

Evaluation of a balloon occlusion and aspiration system for protection from distal embolization during stenting in saphenous vein grafts

      Abstract

      Distal embolization after angioplasty in degenerated saphenous vein grafts (SVGs) results in high rates of periprocedural myonecrosis and mortality. Temporary protection of the distal microcirculation with aspiration of dislodged debris may improve the safety of SVG intervention. To evaluate the feasibility, safety, and efficacy of distal protection using the PercuSurge GuardWire Occlusion and Aspiration System, 103 consecutive patients undergoing planned stenting of 105 SVG lesions were prospectively enrolled in a multinational, multicenter study. Before angioplasty, protection of the distal circulation was achieved with the PercuSurge GuardWire distal balloon occlusion system, followed by stenting and debris aspiration. Quality assurance measures in the study included independent on-site data monitoring, clinical event adjudication, data analysis, and use of multiple core laboratories. Mean graft age was 8.9 ± 4.0 years. The duration of distal balloon inflation was 5.4 ± 3.7 minutes; premature balloon deflation for ischemia was not required in any patient. Macroscopically visible red and/or yellow debris was extracted in 91% of patients. By core lab analysis, postprocedural Thrombolysis In Myocardial Infarction-III flow was present in 98.9% of grafts (vs 83.5% before intervention). No patient developed angiographic evidence of no reflow or distal embolization. Postprocedural creatine phosphokinase MB isozyme levels were elevated to >3 × normal in only 5 patients (5%), and 97 patients (94%) were free of major adverse events at 30 days. We conclude that the GuardWire distal balloon occlusion and aspiration system is an effective and safe method for protecting distal microcirculation from the adverse consequences of embolization during mechanical intervention of degenerated SVGs.
      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'

      Subscribe:

      Subscribe to American Journal of Cardiology
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect

      References

        • Oesterle S.N
        • Hayase M
        • Baim D.S
        • Teristein P.S
        • Ramee S.R
        • Whitlow P.L
        • Webb J
        • Virmani R
        An embolization containment device.
        Cathet Cardiovasc Intervent. 1999; 47: 243-250
        • Webb J.G
        • Carere R.G
        • Virmani R
        • Baim D.S
        • Teristein P.S
        • Whitlow P.L
        • McQueen C
        • Kolodgie F.D
        • Buller E
        • Dodek A
        • Mancini G.B
        • Oesterle S.N
        Retrieval and analysis of particulate debris after saphenous vein graft intervention.
        J Am Coll Cardiol. 1999; 32: 468-475
        • Lefkovits J
        • Holmes D.R
        • Califf R.M
        • Safian R.D
        • Pieper K
        • Keeler G
        • Topol E.J
        Predictors and sequelae of distal embolization during saphenous vein graft intervention from the CAVEAT-II Trial.
        Circulation. 1999; 92: 734-740
        • Hong M.K
        • Mehran R
        • Dangas G
        • Mintz G.S
        • Lansky A.J
        • Pichard A.D
        • Kent K.M
        • Satler L.F
        • Stone G.W
        • Leon M.B
        Creatine kinase-MB enzyme elevation following successful saphenous vein graft intervention is associated with late mortality.
        Circulation. 1999; 100: 2400-2405
        • de Feyter P
        • van Suylen R.J
        • de Jaegere P.P
        • Topol E.J
        • Serruys P.W
        Balloon angioplasty for the treatment of lesions in saphenous vein bypass grafts.
        J Am Coll Cardiol. 1999; 21: 1539-1549
        • Hong M.K
        • Mehran R
        • Dangas G
        • Mintz G.S
        • Lansky A
        • Kent K.M
        • Pichard A.D
        • Satler L.F
        • Stone G.W
        • Leon M.B
        Are we making progress with percutaneous saphenous vein graft treatment? A comparison of 1990 to 1994 and 1995 to 1998 results.
        J Am Coll Cardiol. 1999; 38: 150-154
        • Ambrosio G
        • Weissman H.F
        • Mannisi J.A
        • Becker L.C
        Progressive impairment of regional myocardial perfusion after initial restoration of postischemic blood flow.
        Circulation. 1999; 80: 1846-1861
        • Kloner R.A
        • Ganote C.E
        • Jennings R.B
        The “no-reflow” phenomenon following temporary coronary occlusion in the dog.
        J Clin Invest. 1999; 54: 1496-1508
        • Seydoux C
        • Goy J.J
        • Davies G
        Platelet and neutrophil imaging techniques in the investigation of the response to thrombolytic therapy and the no-reflow phenomenon.
        Am Heart J. 1999; 125: 1142-1147
        • Byrne J
        • Smith W.J
        • Campbell A
        • Lynch M.P
        Controlled reperfusion of the regionally ischemic myocardium with leukocyte depleted blood reduces stunning, the no-reflow phenomenon, and infarct size.
        Cardiovasc Surg. 1999; 103: 66-72
        • Przyklenk K
        • Bauer B
        • Kloner R.A
        Reperfusion of hibernating myocardium:.
        Am Heart J. 1999; 123: 575-588
        • Nicolini F.A
        • Nichols W.W
        • Saldeen T.G
        • Khan S
        • Mehta J.L
        Adjunctive therapy with low molecular weight heparin with recombinant tissue-type plasminogen activator causes sustained reflow in canine coronary thrombosis.
        Am Heart J. 1999; 124: 280-288
        • Abbo K.M
        • Dooris M
        • Glazier S
        • O’Neill W.W
        • Byrd D
        • Grines C.L
        • Safian R.D
        Features and outcome of no-reflow after percutaneous coronary intervention.
        Am J Cardiol. 1999; 75: 778-782
        • Stein B
        • Fuster V
        • Halperin J.L
        • Chesebro J.H
        Antithrombotic therapy in cardiac disease. An emerging approach based on pathogenesis and risk.
        Circulation. 1999; 80: 1501-1513
        • Ellis S.G
        • Lincoff A.M
        • Miller D
        • Tcheng J.E
        • Kleiman N.S
        • Kereiakes D
        • Califf R
        • Topol E.J
        Reduction in complications of angioplasty with abciximab occurs largely independently of baseline lesion morphology.
        J Am Coll Cardiol. 1999; 32: 1619-1623
        • Safian R.D
        • Grines C.L
        • May M.A
        • Lichtenberg A
        • Juran N
        • Schreiber T.L
        • Pavlides G
        • Meany T.B
        • Savas V
        • O’Neill W.W
        Clinical and angiographic results of transluminal extraction coronary atherectomy in saphenous vein bypass grafts.
        Circulation. 1999; 89: 302-312
        • Hong M.K
        • Popma J.J
        • Pichard A.D
        • Kent K.M
        • Satler L.F
        • Chuang Y.C
        • Mintz G.S
        • Keller M.B
        • Leon M.B
        Clinical significance of distal embolization after transluminal extraction atherectomy in diffusely diseased saphenous vein grafts.
        Am Heart J. 1999; 127: 1496-1503
        • Hamburger J
        • Serruys P.W
        Treatment of thrombus containing lesions in diseased native coronary arteries and saphenous vein bypass grafts using the AngioJet Rapid Thrombectomy System.
        Herz. 1999; 22: 318-321
        • Teirstein P.S
        • Mann J.T
        • Cundey P.E
        • Schecter E
        • Jacobs W.C
        • Grines C.L
        • Stagman D.J
        • Lansky A.J
        • Hultquist M.A
        • et al.
        Low- versus high-dose recombinant urokinase for the treatment of chronic saphenous vein graft occlusion.
        Am J Cardiol. 1999; 3: 1623-1628
        • Cohen D.J
        • Ramee S
        • Baim D.S
        • Sharma S
        • Carrozza J.P
        • Cosgrove R
        • Jones N
        • Berezin R.H
        • Cutlip D.E
        • Ho K.K
        • Kuntz R.E
        Economic assessment of rheolytic thrombectomy versus intracoronary urokinase for treatment of extensive intracoronary thrombus:.
        Am Heart J. 1999; 142: 648-656
        • Misumi K
        • Matthews R.V
        • Sun G.W
        • Mayeda G
        • Burstein S
        • Shook T.L
        Reduced distal embolization with transluminal extraction atherectomy compared to balloon angioplasty for saphenous vein graft disease.
        Cathet Cardiovasc Diagn. 1999; 39: 246-251