Chapter 25
Specialized Balloons in Percutaneous Coronary Intervention
Cutting, Scoring, Gliding, and Drug-Eluting Balloons
Bimmer Claessen,
José P.S. Henriques,
George D. Dangas,
Bimmer Claessen
Search for more papers by this authorJosé P.S. Henriques
Search for more papers by this authorGeorge D. Dangas
Search for more papers by this authorBimmer Claessen,
José P.S. Henriques,
George D. Dangas,
Bimmer Claessen
Search for more papers by this authorJosé P.S. Henriques
Search for more papers by this authorGeorge D. Dangas
Search for more papers by this authorBook Editor(s):George D. Dangas MD, MACC, MSCAI, FAHA, FESC,
Carlo Di Mario MD, PhD, FRCP, FACC, FSCAI, FESC,
Holger Thiele MD,
Peter Barlis MBBS, MPH, PHD, FACC, FESC, FRACP,
Tayo Addo MD, Bimmer Claessen MD, Christian Hengstenberg MD, Nicholas Kipshidze MD,
George D. Dangas MD, MACC, MSCAI, FAHA, FESC
Professor of Medicine (Cardiology) & Surgery (Vascular) Professor of Cardiology Adjunct Professor of Internal Medicine
Icahn School of Medicine at Mount Sinai, Mount Sinai Hospital, New York, NY, USA
National Kapodistrian University of Athens, Greece
Medical University of Vienna, Austria
Search for more papers by this authorCarlo Di Mario MD, PhD, FRCP, FACC, FSCAI, FESC
Professor of Cardiology Director of the Structural Interventional Cardiology Division Honorary Consultant
University of Florence
University Hospital Careggi, Florence, Italy
Cardiologist Royal Brompton Hospital, London, UK
Search for more papers by this authorHolger Thiele MD
Professor of Cardiology at University of Leipzig
Heart Center Leipzig at University of Leipzig, Leipzig, Germany
Search for more papers by this authorPeter Barlis MBBS, MPH, PHD, FACC, FESC, FRACP
Professor of Cardiology Interventional Cardiologist
University of Melbourne, Melbourne, Victoria, Australia
St Vincent's & Northern Hospitals Victoria, Australia
Search for more papers by this authorFirst published: 06 May 2022
Summary
The field of interventional cardiology has progressed significantly since the very first coronary balloon angioplasty on 16 September 1977. Balloons used during percutaneous coronary interventions (PCI) have evolved from the only available therapy to a more complementary role in lesion preparation and post-stenting optimization. Among others, specialized balloons have been developed to optimize lesion preparation in slippery or calcified lesions, to optimize stent results of aorto-ostial lesions, to access side branches after main vessel stenting in bifurcation PCI and for local drug delivery. Even today many new types of specialized coronary balloons are being developed and investigated. This chapter provides an overview of specialty balloons currently used in the field of interventional cardiology.
References
- Serruys PW , de Jaegere P , Kiemeneij F , et al . A comparison of balloon-expandable-stent implantation with balloon angioplasty in patients with coronary artery disease. Benestent Study Group . N Engl J Med. 1994 ; 331 ( 8 ): 489 – 95 .
- Fischman DL , Leon MB , Baim DS , et al . A randomized comparison of coronary-stent placement and balloon angioplasty in the treatment of coronary artery disease. Stent Restenosis Study Investigators . N Engl J Med. 1994 ; 331 ( 8 ): 496 – 501 .
- Claessen BE , Henriques JP , Jaffer FA , et al . Stent thrombosis: a clinical perspective . JACC Cardiovascular Interventions. 2014 ; 7 ( 10 ): 1081 – 92 .
- Dangas GD , Claessen BE , Caixeta A , et al . In-stent restenosis in the drug-eluting stent era . J Am Coll Cardiol. 2010 ; 56 ( 23 ): 1897 – 907 .
- Navarese EP , Tandjung K , Claessen B , et al . Safety and efficacy outcomes of first and second generation durable polymer drug eluting stents and biodegradable polymer biolimus eluting stents in clinical practice: comprehensive network meta-analysis . BMJ. 2013 ; 347 : f6530 .
- Kawase Y , Saito N , Watanabe S , et al . Utility of a scoring balloon for a severely calcified lesion: bench test and finite element analysis . Cardiov Interv and Ther. 2014 ; 29 ( 2 ): 134 – 9 .
- Schmidt T , Hansen S , Meincke F , et al. Safety and efficacy of lesion preparation with the AngioSculpt Scoring Balloon in left main interventions: the ALSTER Left Main registry . EuroIntervention: journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology . 2015 .
- Moses JW , Carlier S , Moussa I . Lesion preparation prior to stenting . Reviews in Cardiov Med. 2004 ; 5 Suppl 2 : S16 – 21 .
- Stone GW , Maehara A , Witzenbichler B , et al . Intracoronary abciximab and aspiration thrombectomy in patients with large anterior myocardial infarction: the INFUSE-AMI randomized trial . JAMA. 2012 ; 307 ( 17 ): 1817 – 26 .
- Briguori C , Visconti G , Donahue M , et al . The glider balloon: a useful device for the treatment of bifurcation lesions . Int. J. Cardiol. 2013 ; 168 ( 4 ): 3208 – 11 .
- Indermuehle A , Bahl R , Lansky AJ , et al . Drug-eluting balloon angioplasty for in-stent restenosis: a systematic review and meta-analysis of randomised controlled trials . Heart. 2013 ; 99 ( 5 ): 327 – 33 .
- Barath P , Fishbein MC , Vari S , Forrester JS . Cutting balloon: a novel approach to percutaneous angioplasty . Amer J Cardiol. 1991 ; 68 ( 11 ): 1249 – 52 .
- Popma JJ , Lansky AJ , Purkayastha DD , et al . Angiographic and Clinical Outcome after Cutting Balloon Angioplasty . J Invasive Cardiol . 1996 ; 8 Suppl A : 12A – 9A .
- 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 . 2014 ; 35 ( 37 ): 2541 – 619 .
- Levine GN , Bates ER , Blankenship JC , et al . 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention. A report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Society for Cardiovascular Angiography and Interventions . J Am Coll Cardiol . 2011 ; 58 ( 24 ): e44 – 122 .
- Secco GG , Di Mario C . A new dedicated ultrashort steerable balloon for side branch ostial dilatation . Catheter Cardiovasc Int. 2011 ; 77 ( 3 ): 363 – 6 .
- Secco GG , Rittger H , Hoffmann S , et al . The glider registry: A prospective multicentre registry of a new ultrashort dedicated balloon for side-branch ostial dilatation . Catheter Cardiovasc Int . 2013 .
- Saraf S , Ong PJ , Gorog DA . ClearWay RX – Rapid exchange therapeutic perfusion catheter . EuroInterv. 2008 ; 3 ( 5 ): 639 – 42 .
- Nguyen-Trong PJ , Martinez Parachini JR , Resendes E , et al . Procedural outcomes with use of the flash ostial system in aorto-coronary ostial lesions . Catheter Cardiovasc Int. 2016 ; 88 ( 7 ): 1067 – 74 .
- Axel DI , Kunert W , Goggelmann C , et al . Paclitaxel inhibits arterial smooth muscle cell proliferation and migration in vitro and in vivo using local drug delivery . Circulation. 1997 ; 96 ( 2 ): 636 – 45 .
- Clever YP , Peters D , Calisse J , et al . Novel Sirolimus-Coated Balloon Catheter: in vivo Evaluation in a Porcine Coronary Model . Circ Cardiovasc Interv. 2016 ; 9 ( 4 ): e003543 .
-
Bangalore S
,
Toklu B
,
Amoroso N
,
et al
.
Bare metal stents, durable polymer drug eluting stents, and biodegradable polymer drug eluting stents for coronary artery disease: mixed treatment comparison meta-analysis
.
BMJ.
2013
;
347
:f6625.
10.1136/bmj.f6625 Google Scholar
- Tagliareni F , La Manna A , Saia F , et al . Long-term clinical follow-up of drug-eluting stent restenosis treatment: retrospective analysis from two high volume catheterisation laboratories . EuroInterv. 2010 ; 5 ( 6 ): 703 – 8 .
- Giacoppo D , Alfonso F , Xu B , et al . Paclitaxel-coated balloon angioplasty vs. drug-eluting stenting for the treatment of coronary in-stent restenosis: a comprehensive, collaborative, individual patient data meta-analysis of 10 randomized clinical trials (DAEDALUS study) . Eur Heart J . 2019 .
- Ali RM , Abdul Kader M , Wan Ahmad WA , et al . Treatment of Coronary Drug-Eluting Stent Restenosis by a Sirolimus- or Paclitaxel-Coated Balloon . JACC Cardiovascular interventions. 2019 ; 12 ( 6 ): 558 – 66 .
- Burzotta F , Brancati MF , Trani C , et al . Impact of drug-eluting balloon (pre- or post-) dilation on neointima formation in de novo lesions treated by bare-metal stent: the IN-PACT CORO trial . Heart and Vessels . 2015 .
- Stone GW , Moses JW , Ellis SG , et al . Safety and efficacy of sirolimus- and paclitaxel-eluting coronary stents . N Engl J Med. 2007 ; 356 ( 10 ): 998 – 1008 .
- Fischer D , Scheller B , Schafer A , et al . Paclitaxcel-coated balloon plus bare metal stent vs. sirolimus-eluting stent in de novo lesions: an IVUS study . EuroInterv. 2012 ; 8 ( 4 ): 450 – 5 .
- Naganuma T , Latib A , Sgueglia GA , et al . A 2-year follow-up of a randomized multicenter study comparing a paclitaxel drug-eluting balloon with a paclitaxel-eluting stent in small coronary vessels the BELLO study . Int J Cardiol. 2015 ; 184 : 17 – 21 .
- Jeger RV , Farah A , Ohlow MA , et al . Drug-coated balloons for small coronary artery disease (BASKET-SMALL 2): an open-label randomised non-inferiority trial . The Lancet. 2018 ; 392 ( 10150 ): 849 – 56 .
- Lopez Minguez JR , Nogales Asensio JM , Doncel Vecino LJ , et al . A prospective randomised study of the paclitaxel-coated balloon catheter in bifurcated coronary lesions (BABILON trial): 24-month clinical and angiographic results . EuroInterv. 2014 ; 10 ( 1 ): 50 – 7 .
- Vos NS , Fagel ND , Amoroso G , et al . Paclitaxel-Coated Balloon Angioplasty Versus Drug-Eluting Stent in Acute Myocardial Infarction: The REVELATION Randomized Trial . JACC Cardiovascular Interventions. 2019 ; 12 ( 17 ): 1691 – 9 .
- Scheller B , Ohlow MA , Ewen S , et al . Bare metal or drug-eluting stent versus drug-coated balloon in non-ST-elevation myocardial infarction: the randomised PEPCAD NSTEMI trial . EuroInterv. 2020 ; 15 ( 17 ): 1527 – 33 .
- Rissanen TT , Uskela S , Eranen J , et al . Drug-coated balloon for treatment of de-novo coronary artery lesions in patients with high bleeding risk (DEBUT): a single-blind, randomised, non-inferiority trial . The Lancet. 2019 ; 394 ( 10194 ): 230 – 9 .
- Katsanos K , Spiliopoulos S , Kitrou P , et al . Risk of Death Following Application of Paclitaxel-Coated Balloons and Stents in the Femoropopliteal Artery of the Leg: A Systematic Review and Meta-Analysis of Randomized Controlled Trials . J Am Heart Assoc. 2018 ; 7 ( 24 ): e011245 .
- Rocha-Singh KJ , Duval S , Jaff MR , et al . Mortality and Paclitaxel-Coated Devices: An Individual Patient Data Meta-Analysis . Circulation . 2020 .
- Scheller B , Vukadinovic D , Jeger R , et al . Survival After Coronary Revascularization With Paclitaxel-Coated Balloons . J Am Coll Cardiol. 2020 ; 75 ( 9 ): 1017 – 28 .
