Vol. 145 No. 5152 (2015)
Early safety outcome following transcatheter aortic valve implantation: is the amount of contrast media used a matter of concern?
- Jan Vontobel
- Mathias Possner
- Philipp Schütz
- Beat Müller
- Maurizio Taramasso
- Roland K Binder
- Sabine Haueis
- Adrian Attinger-Toller
- Francesco Maisano
- Fabian Nietlispach
QUESTIONS UNDER STUDY: The study objective was to evaluate the impact of the amount of contrast medium used for transcatheter aortic valve implantation (TAVI) on short-term outcome. Patients undergoing TAVI are exposed to repeat contrast medium application both for preprocedural screening and during the TAVI procedure itself. Whether the amount of contrast media is associated with worse outcome is unclear.
METHODS: A total of 257 patients were included (median age 82.7 years) and divided into two groups with preserved and reduced kidney function (glomerular filtration rate <60 ml/min/1.73 m2), respectively. Total volume of contrast media administered during and within 5 days prior to TAVI was analysed. A combined early safety endpoint at 30 days was evaluated.
RESULTS: The early safety endpoint was reached by 31 patients and acute kidney injury occurred in 22 patients. The median total volume of contrast media administered was 144 ml (interquartile range 81–225 ml). The amount of contrast did not independently predict the early safety endpoint in the overall population (odds ratio [OR] 0.93, 95% confidence interval [CI] 0.56 to 1.53, p = 0.774) and in subgroups with preserved and reduced kidney function. Change in creatinine was an independent strong predictor of the early safety endpoint in the overall population (OR 18.13, 95% CI 4.70 to 69.99, p <0.001), as well as in subgroups with preserved and reduced kidney function. The amount of contrast did not predict a change in creatinine within 72 hours following TAVI (r = 0.02, 95% CI –0.02 to 0.07, p = 0.368).
CONCLUSION: Decreased kidney function after TAVI influences outcome. When rather small amounts of contrast media are used for screening and the TAVI procedure itself, the amount of contrast media seems not to be an independent predictor of outcome, further suggesting that decreased kidney function after TAVI is multifactorial.
- Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, et al. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010;363:1597–607.
- Walther T, Hamm CW, Schuler G, Berkowitsch A, Kötting J, Mangner N, et al. Perioperative Results and Complications in 15,964 Transcatheter Aortic Valve Replacements: Prospective Data From the GARY Registry. J Am Coll Cardiol. 2015;65:2173–80.
- Wenaweser P, Stortecky S, Heg D, Tueller D, Nietlispach F, Falk V, et al. Short-term clinical outcomes among patients undergoing transcatheter aortic valve implantation in Switzerland: the Swiss TAVI registry. EuroIntervention. 2014;10:982–9.
- Thomas M, Schymik G, Walther T, Himbert D, Lefèvre T, Treede H, et al. Thirty-day results of the SAPIEN aortic Bioprosthesis European Outcome (SOURCE) Registry: A European registry of transcatheter aortic valve implantation using the Edwards SAPIEN valve. Circulation. 2010;122:62–9.
- Mack MJ, Brennan JM, Brindis R, Carroll J, Edwards F, Grover F, et al. Outcomes following transcatheter aortic valve replacement in the United States. JAMA. 2013;310:2069–77.
- Gilard M, Eltchaninoff H, Iung B, Donzeau-Gouge P, Chevreul K, Fajadet J, et al. Registry of transcatheter aortic-valve implantation in high-risk patients. N Engl J Med. 2012;366:1705–15.
- Rodes-Cabau J, Webb JG, Cheung A, Ye J, Dumont E, Feindel CM, et al. Transcatheter aortic valve implantation for the treatment of severe symptomatic aortic stenosis in patients at very high or prohibitive surgical risk: acute and late outcomes of the multicenter Canadian experience. J Am Coll Cardiol. 2010;55:1080–90.
- Tamburino C, Capodanno D, Ramondo A, Petronio AS, Ettori F, Santoro G, et al. Incidence and predictors of early and late mortality after transcatheter aortic valve implantation in 663 patients with severe aortic stenosis. Circulation. 2011;123:299–308.
- Zahn R, Gerckens U, Grube E, Linke A, Sievert H, Eggebrecht H, et al. Transcatheter aortic valve implantation: first results from a multi-centre real-world registry. Eur Heart J. 2011;32:198–204.
- Lepor NE. Radiocontrast nephropathy: the dye is not cast. Rev Cardiovasc Med. 2000;1:43–54.
- Aregger F, Wenaweser P, Hellige GJ, Kadner A, Carrel T, Windecker S, et al. Risk of acute kidney injury in patients with severe aortic valve stenosis undergoing transcatheter valve replacement. Nephrol Dial Transplant. 2009;24:2175–9.
- Marenzi G, Lauri G, Assanelli E, Campodonico J, De Metrio M, Marana I, et al. Contrast-induced nephropathy in patients undergoing primary angioplasty for acute myocardial infarction. J Am Coll Cardiol. 2004;44:1780–5.
- Madershahian N, Scherner M, Liakopoulos O, Rahmanian P, Kuhn E, Hellmich M, et al. Renal impairment and transapical aortic valve implantation: impact of contrast medium dose on kidney function and survival. Eur J Cardiothorac Surg. 2012;41:1225–32.
- Barbanti M, Latib A, Sgroi C, Fiorina C, De Carlo M, Bedogni F, et al. Acute kidney injury after transcatheter aortic valve implantation with self-expanding CoreValve prosthesis: results from a large multicentre Italian research project. EuroIntervention. 2014;10:133–40.
- D’Ascenzo F, Moretti C, Salizzoni S, Bollati M, D’Amico M, Ballocca F, et al. 30 days and midterm outcomes of patients undergoing percutaneous replacement of aortic valve according to their renal function: a multicenter study. Int J Cardiol. 2013;167:1514–8.
- Schnabel RB, Seiffert M, Wilde S, Schirmer J, Koschyk DH, Conradi L, et al. Kidney injury and mortality after transcatheter aortic valve implantation in a routine clinical cohort. Catheter Cardiovasc Interv. 2015;85:440–7.
- Arrigo M, Maisano F, Haueis S, Binder RK, Taramasso M, Nietlispach F. Transcatheter aortic-valve implantation with one single minimal contrast media injection. Catheter Cardiovasc Interv. 2015;85:1248–53.
- Kappetein AP, Head SJ, Genereux P, Piazza N, van Mieghem NM, Blackstone EH, et al. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document. Eur Heart J. 2012;33:2403–18.
- Levey AS, Bosch JP, Lewis JB, Greene T, Rogers N, Roth D. A more accurate method to estimate glomerular filtration rate from serum creatinine: a new prediction equation. Modification of Diet in Renal Disease Study Group. Ann Intern Med. 1999;130:461–70.
- Shahian DM, O’Brien SM, Filardo G, Ferraris VA, Haan CK, Rich JB, et al. The Society of Thoracic Surgeons 2008 cardiac surgery risk models: part 3 – valve plus coronary artery bypass grafting surgery. Ann Thorac Surg. 2009;88:S43–62.
- Gurvitch R, Tay EL, Wijesinghe N, Ye J, Nietlispach F, Wood DA, et al. Transcatheter aortic valve implantation: lessons from the learning curve of the first 270 high-risk patients. Catheter Cardiovasc Interv. 2011;78:977–84.
- Nietlispach F, Wijesinghe N, Wood D, Carere RG, Webb JG. Current balloon-expandable transcatheter heart valve and delivery systems. Catheter Cardiovasc Interv. 2010;75:295–300.
- Stahli BE, Bunzli R, Grunenfelder J, Buhler I, Felix C, Bettex D, et al. Transcatheter aortic valve implantation (TAVI) outcome according to standardized endpoint definitions by the Valve Academic Research Consortium (VARC). J Invasive Cardiol. 2011;23:307–12.
- Nuis RJ, Piazza N, Van Mieghem NM, Otten AM, Tzikas A, Schultz CJ, et al. In-hospital complications after transcatheter aortic valve implantation revisited according to the Valve Academic Research Consortium definitions. Catheter Cardiovasc Interv. 2011;78:457–67.
- Bagur R, Webb JG, Nietlispach F, Dumont E, De Larochelliere R, Doyle D, et al. Acute kidney injury following transcatheter aortic valve implantation: predictive factors, prognostic value, and comparison with surgical aortic valve replacement. Eur Heart J. 2010;31:865–74.
- Allende R, Webb JG, Munoz-Garcia AJ, de Jaegere P, Tamburino C, Dager AE, et al. Advanced chronic kidney disease in patients undergoing transcatheter aortic valve implantation: insights on clinical outcomes and prognostic markers from a large cohort of patients. Eur Heart J. 2014;35:2685–96.
- Najjar M, Salna M, George I. Acute kidney injury after aortic valve replacement: incidence, risk factors and outcomes. Expert Rev Cardiovasc Ther. 2015;13:301–16.
- Loef BG, Epema AH, Smilde TD, Henning RH, Ebels T, Navis G, et al. Immediate postoperative renal function deterioration in cardiac surgical patients predicts in-hospital mortality and long-term survival. J Am Soc Nephrol. 2005;16:195–200.
- Moretti C, D’Amico M, D’Ascenzo F, Colaci C, Salizzoni S, Tamburino C, et al. Impact on prognosis of periprocedural bleeding after TAVI: mid-term follow-up of a multicenter prospective study. J Interv Cardiol. 2014;27:293–9.
- Genereux P, Cohen DJ, Williams MR, Mack M, Kodali SK, Svensson LG, et al. Bleeding complications after surgical aortic valve replacement compared with transcatheter aortic valve replacement: insights from the PARTNER I Trial (Placement of Aortic Transcatheter Valve). J Am Coll Cardiol. 2014;63:1100–9.
- Nietlispach FMB. Transcatheter aortic valve implantation – an attractive treatment option. Eur Geriatr Med. 2013;4:260–5.
- Golshahi J, Nasri H, Gharipour M. Contrast-induced nephropathy; A literature review. J Nephropathol. 2014;3:51–6.
- Najjar M, Yerebakan H, Sorabella RA, Guglielmetti L, Vandenberge J, Kurlansky P, et al. Reversibility of chronic kidney disease and outcomes following aortic valve replacement. Interact Cardiovasc Thorac Surg. 2015;21:499–505.
- Wenaweser P, Pilgrim T, Roth N, Kadner A, Stortecky S, Kalesan B, et al. Clinical outcome and predictors for adverse events after transcatheter aortic valve implantation with the use of different devices and access routes. Am Heart J. 2011;161:1114–24.
- Généreux P, Webb JG, Svensson LG, Kodali SK, Satler LF, Fearon WF, et al. Vascular complications after transcatheter aortic valve replacement: insights from the PARTNER (Placement of AoRTic TraNscathetER Valve) trial. J Am Coll Cardiol. 2012;60:1043–52.
- Kodali S, Pibarot P, Douglas PS, Williams M, Xu K, Thourani V, et al. Paravalvular regurgitation after transcatheter aortic valve replacement with the Edwards sapien valve in the PARTNER trial: characterizing patients and impact on outcomes. Eur Heart J. 2015;36:449–56.
- Chen C, Zhao ZG, Liao YB, Peng Y, Meng QT, Chai H, et al. Impact of renal dysfunction on mid-term outcome after transcatheter aortic valve implantation: a systematic review and meta-analysis. PLoS One. 2015;10:e0119817.
- Hahn RT. Guidance of transcatheter aortic valve replacement by echocardiography. Current Cardiol Rep. 2014;16:442.
- Nietlispach F, Leipsic J, Al-Bugami S, Masson JB, Carere RG, Webb JG. CT of the ilio-femoral arteries using direct aortic contrast injection: proof of feasibility in patients screened towards percutaneous aortic valve replacement. Swiss Med Wkly. 2009;139:458–62.