Advertisement

Effect of severe left ventricular systolic dysfunction on hospital outcome after transcatheter aortic valve implantation or surgical aortic valve replacement: Results from a propensity-matched population of the Italian OBSERVANT multicenter study

Published:November 21, 2013DOI:https://doi.org/10.1016/j.jtcvs.2013.10.006

      Objective

      Despite demonstration of the superior outcomes of transcatheter aortic valve implantation (TAVI) versus optimal medical therapy for severe left ventricular systolic dysfunction, studies comparing TAVI and surgical aortic valve replacement (AVR) in this high-risk group have been lacking.

      Methods

      We performed propensity matching for age, gender, baseline comorbidities, previous interventions, priority at hospital admission, frailty score, New York Heart Association class, EuroSCORE, and associated cardiac diseases. Next, the 30-day mortality and procedure-related morbidity of 162 patients (81 TAVI vs 81 AVR) with severe left ventricular systolic dysfunction (ejection fraction ≤ 35%) were analyzed at the Italian National Institute of Health.

      Results

      The 30-day mortality was comparable (P = .37) between the 2 groups. The incidence of periprocedural acute myocardial infarction (P = .55), low output state (P = .27), stroke (P = .36), and renal dysfunction (peak creatinine level, P = .57) was also similar between the 2 groups. TAVI resulted in significantly greater postprocedural permanent pacemaker implantation (P = .01) and AVR in more periprocedural transfusions (P < .01) despite a similar transfusion rate per patient (2.8 ± 3.7 for TAVI vs 4.4 ± 3.8 for AVR; P = .08). The postprocedural intensive care unit stay (median, 2 days after TAVI vs 3 days after AVR; P = .34), intermediate care unit stay (median, 0 days after both TAVI and AVR; P = .94), and hospitalization (median, 11 days after TAVI vs 14 days after AVR; P = .51) were comparable.

      Conclusions

      In patients with severe left ventricular systolic dysfunction, both TAVI and AVR are valid treatment options, with comparable hospital mortality and periprocedural morbidity. Comparisons of the mid- to long-term outcomes are mandatory.

      CTSNet classification

      Abbreviations and Acronyms:

      AMI (acute myocardial infarction), AVR (aortic valve replacement), FRANCE-2 (French Transcatheter Aortic Valve Intervention), ICU (intensive care unit), ImCU (intermediate care unit), LCOS (low cardiac output syndrome), LVEF (left ventricular ejection fraction), PARTNER (Placement of AoRTic TraNscathetER), PPM (permanent pacemaker), SAS (severe aortic stenosis), SLVSD (severe left ventricular systolic dysfunction), TAVI (transcatheter aortic valve implantation), VARC (Valve Academic Research Consortium)
      To read this article in full you will need to make a payment

      References

        • Barili F.
        • Pacini D.
        • Capo A.
        • Ardemagni E.
        • Pellicciari G.
        • Zanobini M.
        • et al.
        Reliability of new scores in predicting perioperative mortality after isolated aortic valve surgery: a comparison with the Society of Thoracic Surgeons score and logistic EuroSCORE.
        Ann Thorac Surg. 2013; 95: 1539-1544
        • Tribouilloy C.
        • Levy F.
        • Rusinaru D.
        • Guéret P.
        • Petit-Eisenmann H.
        • Baleynaud S.
        • et al.
        Outcome after aortic valve replacement for low-flow/low-gradient aortic stenosis without contractile reserve on dobutamine stress echocardiography.
        J Am Coll Cardiol. 2009; 53: 1865-1873
        • Iung B.
        • Cachier A.
        • Baron G.
        • Messika-Zeitoun D.
        • Delahave F.
        • Tornos P.
        • et al.
        Decision-making in elderly patients with severe aortic stenosis: why are so many denied surgery?.
        Eur Heart J. 2005; 26: 2714-2720
        • Pilgrim T.
        • Wenasewer P.
        • Meuli F.
        • Huber C.
        • Stortecky S.
        • Seiler C.
        • et al.
        Clinical outcome of high-risk patients with severe aortic stenosis and reduced left ventricular ejection fraction undergoing medical treatment or TAVI.
        PLoS One. 2011; 6: e27556
        • van der Boon R.M.
        • Nuis R.J.
        • Van Mieghem N.M.
        • Benitez L.M.
        • van Geuns R.J.
        • Galema T.W.
        • et al.
        Clinical outcome following transcatheter aortic valve implantation in patients with impaired left ventricular systolic function.
        Catheter Cardiovasc Interv. 2012; 79: 702-710
        • Ewe S.H.
        • Marsan N.A.
        • Pepi M.
        • Delgado V.
        • Tamborini G.
        • Muratori M.
        • et al.
        Impact of left ventricular systolic dysfunction on clinical and echocardiographic outcomes following transcathter aortic valve implantation for severe aortic stenosis.
        Am Heart J. 2010; 160: 1113-1120
        • Fraccaro C.
        • Al-Lamee R.
        • Tarantini G.
        • Maisano F.
        • Napodano M.
        • Montorfano M.
        • et al.
        Transcatheter aortic valve implantation in patients with severe left ventricular dysfunction: immediate and mid-term results, a multicenter study.
        Circ Cardiovasc Interv. 2012; 5: 253-260
        • Herrmann H.C.
        • Pibarot P.
        • Hueter I.
        • Gertz Z.M.
        • Stewart W.J.
        • Kapadia S.
        • et al.
        Predictors of mortality and outcomes of therapy in low-flow severe aortic stenosis: a Placement of Aortic Transcatheter Valves (PARTNER) trial analysis.
        Circulation. 2013; 127: 2316-2326
        • D’Errigo P.
        • Barbanti M.
        • Ranucci M.
        • Onorati F.
        • Covello R.D.
        • Rosato S.
        • et al.
        Transcatheter aortic valve implantation versus surgical aortic valve replacement for severe aortic stenosis: results from an intermediate risk propensity-matched population of the Italian OBSERVANT study.
        Int J Cardiol. 2013; 167: 1945-1952
        • Onorati F.
        • D’Errigo P.
        • Barbanti M.
        • Rosato S.
        • Covello R.D.
        • Maraschini A.
        • et al.
        Results differ between trans-aortic and open surgical aortic valve replacement in women: a propensity-matched study of the Italian OBSERVANT registry.
        Ann Thorac Surg. 2013; 96: 1336-1342
        • Onorati F.
        • D’Errigo P.
        • Barbanti M.
        • Rosato S.
        • Covello R.D.
        • Maraschini A.
        • et al.
        OBSERVANT Investigators. Different impact of female gender on baseline characteristics and major periprocedural outcomes of transcathter and surgical aortic valve interventions: results of the multicenter Italian OBSERVANT registry.
        J Thorac Cardiovasc Surg. July 13, 2013; ([Epub ahead of print])
        • Kappetein A.P.
        • Head S.J.
        • Genereux P.
        • Piazza N.
        • van Mieghem N.M.
        • Blackstone E.H.
        • et al.
        Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document.
        J Thorac Cardiovasc Surg. 2013; 145: 6-23
        • Gotzmann M.
        • Lindstaedt M.
        • Bojara W.
        • Ewers A.
        • Mugge A.
        Clinical outcome of transcatheter aortic valve implantation in patients with low-flow low-gradient aortic stenosis.
        Catheter Cardiovasc Interv. 2012; 79: 693-701
        • Lauten A.
        • Zhan R.
        • Horack M.
        • Sievert H.
        • Linke A.
        • Ferrari M.
        • et al.
        Transcatheter aortic valve implantation in patients with low-flow, low-gradient aortic stenosis.
        J Am Coll Cardiol Intv. 2012; 5: 552-559
        • Stohr R.
        • Dohmen G.
        • Herpetz R.
        • Brehmer K.
        • Aktug O.
        • Koos R.
        • et al.
        Thirty-day outcome after transcatheter aortic valve implantation compared with surgical valve replacement in patients with high-risk aortic stenosis: a matched comparison.
        Coron Artery Dis. 2011; 22: 595-600
        • Conradi L.
        • Seiffert M.
        • Treede H.
        • Silaschi M.
        • Baldus S.
        • Schirmer J.
        • et al.
        Transcatheter aortic valve implantation versus surgical aortic valve replacement: a propensity score analysis in patients at high surgical risk.
        J Thorac Cardiovasc Surg. 2012; 143: 64-71
        • Bagur R.
        • Rodes-Cabau J.
        • Gurvitch R.
        • Dumont E.
        • Velianou J.L.
        • Manazoni J.
        • et al.
        Need for permanent pacemaker as a complication of transcatheter aortic valve implantation and surgical aortic valve replacement in elderly patients with severe aortic stenosis and similar baseline electrocardiographic findings.
        J Am Coll Cardiol Intv. 2012; 5: 540-551
        • Boisclair M.D.
        • Lane D.A.
        • Philippou H.
        • Esnouf M.P.
        • Sheikh S.
        • Hunt B.
        • et al.
        Mechanisms of thrombin generation during surgery and cardiopulmonary bypass.
        Blood. 1993; 82: 3350-3357
        • Dial S.
        • Delabays E.
        • Albert M.
        • Gonzalez A.
        • Camarda J.
        • Law A.
        • et al.
        Hemodilution and surgical hemostasis contribute significantly to transfusion requirements in patients undergoing coronary artery bypass.
        J Thorac Cardiovasc Surg. 2005; 130: 654-661
        • Panzer S.
        • Badr Eslam R.
        • Schneller A.
        • Kaider A.
        • Koren D.
        • Eichelberger B.
        • et al.
        Loss of high-molecular-weight von Willebrand factor multimers mainly affects platelet aggregation in patients with aortic stenosis.
        Thromb Haemost. 2010; 103: 408-414
        • Tchetche D.
        • van der Boon R.M.A.
        • Dumonteil N.
        • Chieffo A.
        • Van Mieghem N.M.
        • Farah B.
        • et al.
        Adverse impact of bleeding and transfusion on the outcome post-transcatheter aortic valve implantation: insights from the Pooled-RotterdAm-Milano-Toulouse In Collaboration Plus (Pragmatic Plus) initiative.
        Am Heart J. 2012; 164: 402-409
        • Gilard M.
        • Eltchaninoff H.
        • Iung B.
        • Donzeau-Gouge P.
        • Chevreul K.
        • Fajadet J.
        • et al.
        • FRANCE-2 Investigators
        Registry of transcatheter aortic-valve implantation in high risk patients.
        N Engl J Med. 2012; 366: 1705-1715
        • Ledwoch J.
        • Franke J.
        • Gerckens U.
        • Kuck K.H.
        • Linke A.
        • Nickenig G.
        • et al.
        Incidence and predictors of permanent pacemaker implantation following transcatheter aortic valve implantation: analysis from the German transcatheter aortic valve interventions registry.
        Catheter Cardiovasc Interv. 2013; 82: E569-E577
        • Clavel M.A.
        • Webb J.G.
        • Pibarot P.
        • Altwegg L.
        • Dumont E.
        • Thompson C.
        • et al.
        Comparison of the hemodynamic performance of percutaneous and surgical bioprostheses for the treatment of severe aortic stenosis.
        J Am Coll Cardiol. 2009; 53: 1883-1891
        • Svensson L.G.
        • Tuzcu M.
        • Kapadia S.
        • Blackstone E.H.
        • Roselli E.E.
        • Gillinov M.A.
        • et al.
        A comprehensive review of the PARTNER trial.
        J Thorac Cardiovasc Surg. 2013; 145: S11-S16
        • Watanabe Y.
        • Hayashida K.
        • Yamamoto M.
        • Mouillet G.
        • Chevalier B.
        • Oguri A.
        • et al.
        Transfemoral aortic valve implantation in patients with an aortic annulus dimension suitable for either the Edwards valve or the CoreValve.
        Am J Cardiol. 2013; 112: 707-713
        • Bauer F.
        • Coutant V.
        • Bernard M.
        • Stepowski D.
        • Tron C.
        • Cribier A.
        • et al.
        Patients with severe aortic stenosis and reduced ejection fraction: earlier recovery of left ventricular systolic function after transcatheter aortic valve implantation compared with surgical valve replacement.
        Echocardiography. 2013; 30: 865-870
        • O’Rourke D.J.
        • Palac R.T.
        • Malenka D.J.
        • Marrin C.A.
        • Arbuckle B.E.
        • Plehn J.F.
        Outcome of mild periprosthetic regurgitation detected by intraoperative transesophageal echocardiography.
        J Am Coll Cardiol. 2001; 38: 163-166
        • Sponga S.
        • Perron J.
        • Dagenais F.
        • Mohammadi S.
        • Baillot R.
        • Doyle D.
        • et al.
        Impact of residual regurgitation after aortic valve replacement.
        Eur J Cardiothorac Surg. 2012; 42: 486-492