International Journal of Cardiology 177 (2014) 520–522

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International Journal of Cardiology journal homepage: www.elsevier.com/locate/ijcard

Letter to the Editor

Lower cardiovascular mortality with Medtronic CoreValve versus Edwards SAPIEN in patients with aortic valve stenosis undergoing transcatheter aortic valve implantation Giandomenico Tarsia ⁎, Costantino Smaldone, Nicola G. Viceconte, Rocco A. Osanna, Vincenza Santillo, Cristiano Cuda, Domenico Polosa, Marco F. Costantino, Giuseppe Del Prete, Giuseppe Pittella, Enrico Scarano, Pierluigi Cappiello, Maurilio Di Natale, Francesco Sisto, Nicola Marraudino, Pasquale Lisanti Heart and Great Vessels Department, San Carlo Hospital, Potenza, Italy

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Article history: Received 13 August 2014 Accepted 15 August 2014 Available online 23 August 2014 Keywords: Aortic valve stenosis Transcatheter aortic valve implantation Edwards SAPIEN/SAPIEN XT Medtronic CoreValve Outcome comparisons

Until 2012 two devices for the TAVI procedure have been available in Europe: Medtronic Core-ReValving System (CVS) (Medtronic Inc., Minneapolis, Minnesota) and balloon-expandable Edwards SAPIEN/SAPIEN XT (ES) trans-catheter heart valve (Edwards Lifesciences, Irvine, California) [1,2]. We sought to compare both short- and long-term procedural and clinical outcomes of CV and ES approaches in patients with AVS who underwent TAVI. From June 2010 to December 2012, we enrolled 109 consecutive patients with severe symptomatic AVS undergoing TAVI in our center; informed consent was obtained from each patient and the study protocol conforms to the ethical guidelines of the 1975 Declaration of Helsinki and was approved by the local ethical committee. Fifty-three patients (48.6%) were treated with CVS and 56 (51.4%) with ES. Patients were followed for an average of 18 months (range 7–22 months) in order to review cardiovascular mortality, all-cause mortality and VARC-2 outcomes. Each patient underwent a pre-procedural screening including computed tomography (CT) angiography for aortic annulus sizing

⁎ Corresponding author at: Interventional Cardiology, Heart and Great Vessels Department, San Carlo Hospital, Via Potito Petrone 1, 85100 Potenza, Italy. Tel.: + 39 0971612400, +39 3338795908 (mobile); fax: +39 0971612399. E-mail address: [email protected] (G. Tarsia).

http://dx.doi.org/10.1016/j.ijcard.2014.08.089 0167-5273/© 2014 Elsevier Ireland Ltd. All rights reserved.

and peripheral vessel study and coronary angiography and transesophageal echocardiogram (TE) for the evaluation of associated valvular and structural anomalies. An experienced interventional team performed all the procedures and the valve was chosen according to operator preference. The transfemoral approach was considered as the treatment of choice, whereas transaxillary, transaortic or transapical approaches were evaluated only if the femoral route was considered not suitable for the procedure. Device success was similar in the two groups (CVS 75.5% vs ES 83.9%; p = 0.272). Moderate to severe paravalvular leaks (PVLs) were recorded more frequently in the CVS group (CVS 22.6% vs ES 8.9%; p = 0.049). Only one patient had a worsening of aortic regurgitation from basal to post-procedure in the CVS group. A longer procedural time and more contrast media usage were recorded during the TAVI procedure with CVS and more patients in the CVS group received a PM implantation (CVS 35.6% vs ES 3.6%; p b 0.001). As compared with those undergoing ES implantation, patients who underwent CVS implantation had both lower all-cause mortality (1.9% vs 14.3%; p = 0.032) and cardiovascular mortality (0.0% vs 14.3%; p = 0.006) at 30 days follow-up. Major vascular complications (CVS 1.9% vs ES 7.1%; p = 0.34) and life-threatening or major bleedings (CVS 7.5% vs ES 8.9%; p = 0.7) were similar in the two groups. Stroke rate were very low in both groups (1.9% CVS vs 0% ES; p = 0.4). At long-term follow-up, all-cause mortality was similar in the two groups (CVS 17% vs ES 25%, HR 1.64 — 95% CI: 0.70–3.78, p = 0.25), whereas cardiovascular mortality was lower in the CVS group (CVS 7.5% vs ES 25%, HR 3.63 — 95% CI: 1.19–11.02, p = 0.023). A trend toward lower MACE in the CVS group (CVS 13% vs ES 27%; HR 2.07 — 95% CI: 0.82–5.27; p = 0.126) and no difference in stroke (CVS 5.7% vs ES 1.8%; p = 0.3), myocardial infarction rate (CVS 1.9% vs ES 3.6%; p = 0.59) were found (Fig. 1). Accordingly, the prosthesis type resulted to be the only predictor of cardiovascular death with an adjusted HR of 3.31 (95% CI: 1.05–10.04, p = 0.041) (Fig. 2). The three major experiences published thus far, the Milan experience, the Pragmatic study and the French TAVI registry, were found to have no significant differences in both cardiovascular mortality and all-cause mortality [3–5]. The difference in cardiovascular mortality between the ES and the CVS group could be explained by some differences between our study and previous reports. First, as our experience is more recent, all patients underwent a pre-procedural CT scan that

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Fig. 1. Outcome incidence. Kaplan–Meier estimates of the time to cardiac death or stroke (panel A), to cardiac death (panel B), to death for any cause (panel C) and to MACE (panel D).

has a key role for procedure success since it allows a more precise sizing of the aortic annulus over TE. In previous studies the majority of patients underwent TAVI with CVS without a CT scan for valvular sizing [6]. Second, in the CVS group more patients underwent general anesthesia, tailored to patient conditions, which has been demonstrated to warrant a stable oxygen saturation during all procedural phases and, what could be most important, during management of acute complications. Furthermore, TE monitoring was performed more frequently in the CVS group. TE has been demonstrated to be an effective tool to identify the pericardial effusion readily; it is also very useful to evaluate the correct prosthesis position and the actual amount of the residual PVLs. PVLs represent a frequent consequence of TAVI, however the perception of its impact on mortality became evident only after the publication of the data on the two year follow-up of the PARTNER study, which showed that even mild regurgitation can significantly worsen the prognosis of patients that received an ES [7]. In our series the CVS cohort has a higher rate of moderate PVL, but, interestingly, it does not affect longterm survival. This finding may be explained by the fact that only one patient had a worsening of the PVLs as compared to baseline. Indeed recent data demonstrated that PVLs related to CVS implantations seem to decrease over time [8]. Furthermore the U.S. CoreValve Clinical trial confirmed that the majority of patients with moderate-to-severe

PVLs after implantation had mild or no regurgitations at 1 year, with no impact on survival, and a recent analysis from the UK TAVI registry found that PVLs are associated with a significantly worse outcome with the balloon-expandable, but not with the self-expanding devices [2,9]. In our series 35.6% of patients in the CVS group received a permanent PM, similar to 39.3% rate reported in the German TAVI registry, which seems to exert a protective effect on unexpected (sudden or unknown) death [10,11]. The CHOICE trial was the only randomized study published to date; it found that the device success rate at 30 days was higher for ES mainly due to a reduced rate in PVLs and permanent PM implantation with respect to CVS; this finding was consistent with the results of our study. The clinical secondary end-points assessed in the CHOICE trial were cardiovascular mortality and MACEs that did not significantly differ between ES and CVS at 30 days. This discrepancy with our study might be explained by different characteristics of patient population, which was at higher risk in our study (mean STS score was 11 our study vs 6 in the CHOICE trial), and differences in the vascular accesses used for the procedures (only femoral access allowed in the CHOICE study) [12]. In conclusion, this is the first study that suggests that selfexpandable aortic valve CVS prosthesis is safer than ES balloon-

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Conflict of interest The authors report no relationships that could be construed as a conflict of interest. References

Fig. 2. Hazard ratio for CV death, all-cause death and MACE. The figure shows the impact of implanted prosthesis type on cardiovascular death, all-cause death and MACEs.

expandable prosthesis. This finding is in line with the previous demonstration of some benefits of CVS expandable prosthesis. Major advantages of the self-expandable system are the following: virtual absence of annulus rupture, a devastating complication associated with extremely high mortality and lower risk of abrupt coronary occlusion due to its “hourglass” nitinol frame. Furthermore, the CVS can be considered as a “forgivable” device since it can still be recaptured and repositioned in case of a “too-high” or a “too-deep” implantation, if the proximal third is still anchored to the delivery system, and, when necessary, a Valve-in-Valve procedure can be safely performed. Finally, in case of moderate-to severe PVL the CVS can be safely post-dilated to effectively reduce leak magnitude.

[1] Smith CR, Leon MB, Mack MJ, et al. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med 2011;364:2187–98. [2] Adams DH, Popma JJ, Reardon MJ, et al. Transcatheter aortic-valve replacement with a self-expanding prosthesis. N Engl J Med 2014;370:1790–8. [3] Godino C, Maisano F, Montorfano M, et al. Outcomes after transcatheter aortic valve implantation with both Edwards-SAPIEN and CoreValve devices in a single center. J Am Coll Cardiol Intv 2010;3:1110–21. [4] Chieffo A, Buchanan GL, Van Mieghem NM, et al. Transcatheter aortic valve implantation with the Edwards SAPIEN versus the Medtronic CoreValve Revalving system devices. A multicenter collaborative study: the PRAGMATIC Plus initiative (PooledRotterdAm-Milano-Toulouse In Collaboration). J Am Coll Cardiol 2013;61:830–6. [5] Gilard M, Eltchaninoff H, Iung B, et al. Registry of transcatheter aortic-valve implantation in high-risk patients. N Engl J Med 2012;366:1305–15. [6] Jilaihawi H, Kashif M, Fontana G, et al. Cross-sectional computed tomographic assessment improves accuracy of aortic annular sizing for transcatheter aortic valve replacement and reduces the incidence of paravalvular aortic regurgitation. J Am Coll Cardiol 2012;59:1275–86. [7] Kodali SK, Williams MR, Smith CR, et al. Two-year outcomes after transcatheter or surgical aortic-valve replacement. N Engl J Med 2012;366:1686–95. [8] Abdel-Wahab M, Zahn R, Horack M, et al. Aortic regurgitation after transcatheter aortic valve implantation: incidence and early outcome. Results from the German transcatheter aortic valve interventions registry. Heart 2011;97:899–906. [9] Dworakowski R, Wendler O, Halliday B, et al. Device-dependent association between paravalvar aortic regurgitation and outcome after TAVI. Heart 2014. http://dx.doi. org/10.1136/heartjnl-2013-305390. [10] Zahn R, Gerckens U, Grube E, et al. Transcatheter aortic valve implantation: first results from a multi-center real-world registry. Eur Heart J 2011;32:198–204. [11] Urena M, Webb JG, Tamburrino C, et al. Permanent pacemaker implantation following transcatheter aortic valve implantation: impact on late clinical outcomes and left ventricular function. Circulation 2014;129:1233–43. [12] Abdel-Wahab M, Mehilli J, Frerker C, et al. Comparison of balloon-expandable vs self-expandable valves in patients undergoing transcatheter aortic valve replacement: the CHOICE randomized clinical trial. JAMA 2014 Apr 16;311:1503–14.