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Balloon rupture during aortic valvuloplasty with compliant balloon: predictors and outcomes

  • Ignacio M. SeropianEmail author
  • Francisco J. Romeo
  • Mariano Falconi
  • Carla R. Agatiello
  • Daniel H. Berrocal
Original Article

Abstract

Objectives of the study were the prevalence and clinical consequences of balloon rupture with compliant balloons in balloon aortic valvuloplasty (BAV). Compliant low-profile balloons have been developed to reduce access site complications. Made by thinner materials, these balloons are more prone to rupture. This is a single-center retrospective analysis (2016–2018) of patients undergoing BAV with compliant balloons. Baseline echocardiography and computed tomography (CT) were analyzed. Best cutoff point for calcium score was assessed. Long-term mortality was analyzed with Kaplan–Maier. In vitro test was performed. Rupture occurred in 30/90 (33%) of BAVs independent of risk factors, surgical risk and frailty scores. Patients experiencing rupture had increased mean gradient [53.5 (44–64) vs 44 (35–49) mmHg, p < 0.05] and reduced aortic valve area [0.61 (0.46–0.76) vs 0.76 (0.64–0.83) mm2, p < 0.05]. Valve calcium score on CT > 2686 AU was more frequent in the rupture group (41% vs 10%, p < 0.05) and more patients in the third tertile of calcium score experienced rupture (75% vs 23% vs 41% for second and first tertile, p < 0.05). Median gradient reduction from baseline was similar among groups [30 (20–50) vs 30 (17–39) mmHg]. No patient with rupture had any complication. One-month and long-term mortality were similar (rupture 0% vs 3.5% no rupture from 1 month). In vitro test required more volume and strength to rupture the balloon than used in BAV. Balloon rupture is frequent in BAV using compliant balloons, occurs with more severe aortic stenosis, does not affect BAV efficacy and does not impair outcomes.

Keywords

Balloon aortic valvuloplasty Aortic stenosis Rupture 

Notes

Compliance with ethical standards

Conflict of interest

The authors report no conflicts of interest regarding the manuscript.

Supplementary material

Video1.wmv shows balloon rupture during aortic valvuloplasty observed as a sudden release of diluted contrast into the ascending aorta (MP4 691 kb)

References

  1. 1.
    Nishimura RA, Otto CM, Bonow RO, Carabello BA, Erwin JP III, Fleisher LA, Jneid H, Mack MJ, McLeod CJ, O’Gara PT, Rigolin VH, Sundt TM III, Thompson A. 2017 AHA/ACC focused update of the 2014 AHA/ACC guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on clinical practice guidelines. J Am Coll Cardiol. 2017;70(2):252–89.CrossRefPubMedGoogle Scholar
  2. 2.
    Cribier A, Savin T, Saoudi N, Rocha P, Berland J, Letac B. Percutaneous transluminal valvuloplasty of acquired aortic stenosis in elderly patients: an alternative to valve replacement? Lancet. 1986;1(8742):63–7.CrossRefPubMedGoogle Scholar
  3. 3.
    Cribier A, Eltchaninoff H, Tron C, Bauer F, Agatiello C, Sebagh L, et al. Early experience with percutaneous transcatheter implantation of heart valve prosthesis for the treatment of end-stage inoperable patients with calcific aortic stenosis. J Am Coll Cardiol. 2004;43(4):698–703.CrossRefPubMedGoogle Scholar
  4. 4.
    Badheka AO, Patel NJ, Singh V, Shah N, Chothani A, Mehta K, Deshmukh A, Ghatak A, Rathod A, Desai H, Savani GT, Grover P, Patel N, Arora S, Grines CL, Schreiber T, Makkar R, Rihal CS, Cohen MG, De Marchena E, O’Neill WW. Percutaneous aortic balloon valvotomy in the United States: a 13-year perspective. Am J Med. 2014;127(8):744–753.e3.CrossRefPubMedGoogle Scholar
  5. 5.
    Saia F, Marrozzini C, Ciuca C, Guastaroba P, Taglieri N, Palmerini T, Bordoni B, Moretti C, Dall’ara G, Branzi A, Marzocchi A. Emerging indications, in-hospital and long-term outcome of balloon aortic valvuloplasty in the transcatheter aortic valve implantation era. EuroIntervention. 2013;8(12):1388–97.CrossRefPubMedGoogle Scholar
  6. 6.
    Alkhouli M, Zack CJ, Sarraf M, Bashir R, Nishimura RA, Eleid MF, Nkomo VT, Sandhu GS, Gulati R, Greason KL, Holmes DR, Rihal CS. Morbidity and mortality associated with balloon aortic valvuloplasty: a national perspective. Circ Cardiovasc Interv. 2017;10(5):e004481.  https://doi.org/10.1161/CIRCINTERVENTIONS.116.004481 CrossRefPubMedGoogle Scholar
  7. 7.
    Metz D, Meyer P, Touati C, Coste P, Petiteau PY, Durand P, Faivre R, Lefevre T, Elaerts J. Comparison of 6F with 7F and 8F guiding catheters for elective coronary angioplasty: results of a prospective, multicenter, randomized trial. Am Heart J. 1997;134(1):131–7.CrossRefPubMedGoogle Scholar
  8. 8.
    Büchler JR, Ribeiro EE, Falcão JL, Martinez EE, Büchler RD, Feres F, Maielo JR, Haddad N, Ramires JF, Ellis SG. A randomized trial of 5 versus 7 French guiding catheters for transfemoral percutaneous coronary stent implantation. J Interv Cardiol. 2008;21(1):50–5.CrossRefPubMedGoogle Scholar
  9. 9.
    Dall’Ara G, Santarelli A, Marzocchi A, Bacchi Reggiani ML, Sabattini MR, Moretti C, Marrozzini C, Taglieri N, Baldazzi F, Franco N, Ortolani P, Chiarabelli M, Rodinò G, Piovaccari G, Rapezzi C, Saia F. Vascular complications after balloon aortic valvuloplasty in recent years: incidence and comparison of two hemostatic devices. Catheter Cardiovasc Interv. 2018;91(6):E49–55.CrossRefPubMedGoogle Scholar
  10. 10.
    Généreux P, Webb JG, Svensson LG, Kodali SK, Satler LF, Fearon WF, Davidson CJ, Eisenhauer AC, Makkar RR, Bergman GW, Babaliaros V, Bavaria JE, Velazquez OC, Williams MR, Hueter I, Xu K, Leon MB, PARTNER Trial Investigators. Vascular complications after transcatheter aortic valve replacement: insights from the PARTNER (Placement of AoRTic TraNscathetER Valve) trial. J Am Coll Cardiol. 2012;60(12):1043–52.CrossRefPubMedGoogle Scholar
  11. 11.
    van Kesteren F, van Mourik MS, Vendrik J, Wiegerinck EMA, Henriques JPS, Koch KT, Wykrzykowska JJ, de Winter RJ, Piek JJ, van Lienden KP, Reekers JA, Vis MM, Planken RN, Baan J Jr. Incidence, predictors, and impact of vascular complications after transfemoral transcatheter aortic valve implantation with the SAPIEN 3 prosthesis. Am J Cardiol. 2018;121(10):1231–8.CrossRefPubMedGoogle Scholar
  12. 12.
    Percutaneous balloon aortic valvuloplasty. Acute and 30-day follow-up results in 674 patients from the NHLBI balloon valvuloplasty registry. Circulation. 1991;84(6):2383–97.CrossRefGoogle Scholar
  13. 13.
    Yamen E, Daniels DV, Van H, Yeung AC, Fearon WF. Use of a low-profile, compliant balloon for percutaneous aortic valvuloplasty. Catheter Cardiovasc Interv. 2010;75(5):794–8.CrossRefPubMedGoogle Scholar
  14. 14.
    Rigatelli G, Dell’Avvocata F, Conte L, Lanza D, Giatti S, Del Santo P, Roncon L, Faggian G. Modified balloon aortic valvuloplasty in fragile symptomatic patients unsuitable for both surgical and percutaneous valve replacement. Cardiovasc Revascularization Med. 2018;19(4):444–7.CrossRefGoogle Scholar
  15. 15.
    Kubo S, Fuku Y, Shimamoto T, Kuwayama A, Ohya M, Amano H, Maruo T, Goto T, Komiya T, Kadota K. Vascular injury caused by retrieval of ruptured and detached balloon valvuloplasty catheter during transcatheter aortic valve replacement. JACC Cardiovasc Interv. 2017;10(15):1593–5.CrossRefPubMedGoogle Scholar
  16. 16.
    Eltchaninoff H, Durand E, Borz B, Furuta A, Bejar K, Canville A, Farhat A, Fraccaro C, Godin M, Tron C, Sakhuja R, Cribier A. Balloon aortic valvuloplasty in the era of transcatheter aortic valve replacement: acute and long-term outcomes. Am Heart J. 2014;167(2):235–40.CrossRefPubMedGoogle Scholar
  17. 17.
    Agatiello C, Eltchaninoff H, Tron C, Bauer F, Babaliaros V, Nercolini D, Sebagh L, Vochelet F, Tapiero S, Cribier A. Balloon aortic valvuloplasty in the adult. Immediate results and in-hospital complications in the latest series of 141 consecutive patients at the University Hospital of Rouen (2002–2005). Arch Mal Coeur Vaiss. 2006;99(3):195–200 (French).PubMedGoogle Scholar
  18. 18.
    Baumgartner H, Hung J, Bermejo J, Chambers JB, Edvardsen T, Goldstein S, Lancellotti P, LeFevre M, Miller F Jr, Otto CM. Recommendations on the echocardiographic assessment of aortic valve stenosis: a focused update from the European Association of Cardiovascular Imaging and the American Society of Echocardiography. J Am Soc Echocardiogr. 2017;30(4):372–92.CrossRefPubMedGoogle Scholar
  19. 19.
    Blanke P, Weir-McCall JR, Achenbach S, Delgado V, Hausleiter J, Jilaihawi H, Marwan M, Nørgaard BL, Piazza N, Schoenhagen P, Leipsic JA. Computed tomography imaging in the context of transcatheter aortic valve implantation (TAVI)/transcatheter aortic valve replacement (TAVR): an expert consensus document of the society of cardiovascular computed tomography. JACC Cardiovasc Imaging. 2019;12(1):1–24.CrossRefPubMedGoogle Scholar
  20. 20.
    Feldman T, Glagov S, Carroll JD. Restenosis following successful balloon valvuloplasty: bone formation in aortic valve leaflets. Catheter Cardiovasc Diagn. 1993;29(1):1–7.CrossRefGoogle Scholar
  21. 21.
    van den Brand M, Essed CE, Di Mario C, Plante S, Mochtar B, de Feyter PJ, Suryapranata H, Serruys PW. Histological changes in the aortic valve after balloon dilatation: evidence for a delayed healing process. Br Heart J. 1992;67(6):445–9.CrossRefPubMedPubMedCentralGoogle Scholar
  22. 22.
    Koning R, Cribier A, Asselin C, Mouton-Schleifer D, Derumeaux G, Letac B. Repeat balloon aortic valvuloplasty. Catheter Cardiovasc Diagn. 1992;26:249–54.CrossRefGoogle Scholar
  23. 23.
    Bordoni B, Moretti C, Marrozzini C, Ciuca C, Dall’Ara G, Taffani L, Chiarabelli M, Taglieri N, Berardini A, Guastaroba P, Bacchi-Reggiani ML, Rapezzi C, Marzocchi A, Saia F. Repeated aortic balloon valvuloplasty in elderly patients with aortic stenosis who are not candidates for definitive treatment. J Invasive Cardiol. 2015;27(12):E277–84.PubMedGoogle Scholar
  24. 24.
    Barbanti M, Yang TH, Rodès Cabau J, Tamburino C, Wood DA, Jilaihawi H, Blanke P, Makkar RR, Latib A, Colombo A, Tarantini G, Raju R, Binder RK, Nguyen G, Freeman M, Ribeiro HB, Kapadia S, Min J, Feuchtner G, Gurtvich R, Alqoofi F, Pelletier M, Ussia GP, Napodano M, de Brito FS, Jr Kodali S, Norgaard BL, Hansson NC, Pache G, Canovas SJ, Zhang H, Leon MB, Webb JG, Leipsic J. Anatomical and procedural features associated with aortic root rupture during balloon-expandable transcatheter aortic valve replacement. Circulation. 2013;128(3):244–53.CrossRefPubMedGoogle Scholar
  25. 25.
    Girdauskas E, Owais T, Fey B, Kuntze F, Lauer B, Borger MA, Conradi L, Reichenspurner H, Kuntze T. Subannular perforation of left ventricular outflow tract associated with transcatheter valve implantation: pathophysiological background and clinical implications. Eur J Cardiothorac Surg. 2017;51(1):91–6.CrossRefPubMedGoogle Scholar
  26. 26.
    Hansson NC, Nørgaard BL, Barbanti M, Nielsen NE, Yang TH, Tamburino C, Dvir D, Jilaihawi H, Blanke P, Makkar RR, Latib A, Colombo A, Tarantini G, Raju R, Wood D, Andersen HR, Ribeiro HB, Kapadia S, Min J, Feuchtner G, Gurvitch R, Alqoofi F, Pelletier M, Ussia GP, Napodano M, Sandoli de Brito F Jr, Kodali S, Pache G, Canovas SJ, Berger A, Murphy D, Svensson LG, Rodés-Cabau J, Leon MB, Webb JG, Leipsic J. The impact of calcium volume and distribution in aortic root injury related to balloon-expandable transcatheter aortic valve replacement. J Cardiovasc Comput Tomogr. 2015;9(5):382–92.CrossRefPubMedGoogle Scholar
  27. 27.
    Yang TH, Webb JG, Blanke P, Dvir D, Hansson NC, Nørgaard BL, Thompson CR, Thomas M, Wendler O, Vahanian A, Himbert D, Kodali SK, Hahn RT, Thourani VH, Schymik G, Precious B, Berger A, Wood DA, Pibarot P, Rodés-Cabau J, Jaber WA, Leon MB, Walther T, Leipsic J. Incidence and severity of paravalvular aortic regurgitation with multidetector computed tomography nominal area oversizing or undersizing after transcatheter heart valve replacement with the Sapien 3: a comparison with the Sapien XT. JACC Cardiovasc Interv. 2015;8(3):462–71.CrossRefPubMedGoogle Scholar
  28. 28.
    Athappan G, Patvardhan E, Tuzcu EM, Svensson LG, Lemos PA, Fraccaro C, Tarantini G, Sinning JM, Nickenig G, Capodanno D, Tamburino C, Latib A, Colombo A, Kapadia SR. Incidence, predictors, and outcomes of aortic regurgitation after transcatheter aortic valve replacement: meta-analysis and systematic review of literature. J Am Coll Cardiol. 2013;61(15):1585–95.CrossRefPubMedGoogle Scholar
  29. 29.
    Wong DT, Bertaso AG, Liew GY, Thomson VS, Cunnington MS, Richardson JD, Gooley R, Lockwood S, Meredith IT, Worthley MI, Worthley SG. Relationship of aortic annular eccentricity and paravalvular regurgitation post transcatheter aortic valve implantation with CoreValve. J Invasive Cardiol. 2013;25(4):190–5.PubMedGoogle Scholar

Copyright information

© Japanese Association of Cardiovascular Intervention and Therapeutics 2019

Authors and Affiliations

  1. 1.Interventional Cardiology DepartmentHospital Italiano de Buenos AiresBuenos AiresArgentina
  2. 2.Cardiac Imaging Section, Cardiology DepartmentHospital Italiano de Buenos AiresBuenos AiresArgentina

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