Original Cardiovascular

Transapical Transcatheter Aortic Valve Implantation Using the JenaValve: A One-Year Follow-up Oliver Reuthebuch1 Luca Koechlin1 Friedrich S. Eckstein1

Beat A. Kaufmann2

1 Department of Cardiac Surgery, University Hospital Basel, Basel,

Switzerland 2 Department of Cardiology, University Hospital Basel, Basel, Switzerland 3 Department of Cardiovascular Surgery, University Hospital of Bern, Bern, Switzerland

Arnheid Kessel-Schaefer2

Brigitta Gahl3

Address for correspondence Oliver Reuthebuch, Department of Cardiac Surgery, University Hospital Basel, Spitalstrasse 21, CH-4031, Basel, Switzerland (e-mail: [email protected]).

Abstract

Keywords

► ► ► ► ►

aortic valve and root heart valve transapical TAVI outcomes

received January 15, 2015 accepted after revision March 27, 2015

Objective Since the first transcatheter aortic valve implantation (TAVI) in 2002, TAVI technique has gained an increasing popularity especially in high-risk patients. In this study, we present the first echocardiographic midterm outcome with the secondgeneration transapical JenaValve TAVI system (JenaValve Technology GmbH, Munich, Germany) in patients with aortic stenosis (AS). Methods Between November 2011 and November 2012, a total of 28 patients received transapical TAVI using the JenaValve. Primary endpoint was a combined efficacy endpoint after 1 year, which included all-cause mortality after more than 30 days, failure of current therapy for AS requiring hospitalization for symptoms of valverelated cardiac decompensation or prosthetic heart valve dysfunction. Moreover, we analyzed secondary endpoints after 3 and 12 months including cardiovascular mortality; major stroke; and life-threatening, disabling, or major bleeding. Mean echocardiographic follow-up was 471.35
102.72 days. Results Mean age was 80.43
6.03 years and EuroSCORE II was 8.80
7.21%. Successful implantation was accomplished in 100% (n ¼ 28). Median transvalvular aortic mean pressure gradient was 44.5 mm Hg (interquartile range [IQR]: 34.5; 55.5) preoperatively, 12 mm Hg (IQR: 9; 16) postoperatively, and 11 mm Hg (IQR: 8; 16) after 1 year. After 12 months, no paravalvular leakage was seen in 52.38% of the patients and grade 1 paravalvular leakage was seen in 47.62% of the patients. There was no grade 2 or 3 leakage detected. Stroke, valve thrombosis or dislocation, myocardial infarction, or bleeding was also not observed. However, criteria for the combined efficacy endpoint after 1 year were met in five patients (17.86%). Thirty-day mortality was 14.29% (n ¼ 4) and all-cause mortality after 1 year was 21.43% (n ¼ 6). Conclusion The JenaValve transapical TAVI system is a safe and feasible procedure with low peri- and postoperative complications and convincing midterm performance of the prosthesis.

© Georg Thieme Verlag KG Stuttgart · New York

DOI http://dx.doi.org/ 10.1055/s-0035-1552980. ISSN 0171-6425.

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Thorac Cardiovasc Surg

Reuthebuch et al.

Introduction Since the first transcatheter aortic valve implantation (TAVI) in 2002, the TAVI procedure has been established as a safe and suitable procedure for high-risk patients with aortic stenosis (AS), who are not amenable for conventional heart surgery.1,2 Presently there are more than 10 CE-mark approved TAVI systems on the market. Six of these devices are available for transapical delivery: the first-generation Edwards Sapien, Sapien XT (Edwards Lifesciences Inc., Irvine, California, United States), the second-generation JenaValve (JenaValve Technology GmbH, Munich, Germany), the second-generation Acurate TA (Symetis, Ecublens, Switzerland), the Engager (Medtronic Inc., St. Paul, Minnesota, United States), as well as the Sapien 3 (Edwards Lifesciences Inc.). With the development of the second-generation TAVI valves, the procedure is supposed to be facilitated as well as TAVI-related issues such as paravalvular leakage, annular rupture, ostial encroachment, and rhythm disorders improved. In observational studies, it was shown that paravalvular leakage grade 2 or more is a negative predictor for long-term outcome in TAVI patients.3 By improving correct anatomical positioning, anchoring of the prosthesis as well as improving the delivery system the new approaches promise to improve clinical results and reduce the degree of significant paravalvular leakage. In October 2011, the JenaValve was CE marked as one of the first second-generation TAVI valves. We have promptly integrated the transapical system in our clinical routine and could show very promising short-term results.4 The aim of the present study was to follow up with these patients and to evaluate midterm outcomes after 1 year according to the Valve Academic Research Consortium (VARC II) criteria.5

Methods From November 2011 until August 2014, we have implanted the JenaValve in our clinic. With an average of 35 transapical aortic valve implantations per year, we consider two different systems (JenaValve and Edwards Sapien) sufficient to sustain expertise for both. Being among the first centers to implant the JenaValve, we considerably focused on this valve to achieve early and extensive experience. In this study, the first 28 consecutive patients were included who were treated with the JenaValve between November 2011 and November 2012 with symptomatic severe AS. Severe AS was diagnosed using transthoracic echocardiography (TTE) according to current guidelines and defined as either an instantaneous mean gradient of 40 mm Hg or, in case of reduced ejection fraction, a calculated valve area of 1 cm2 or less. No patient was excluded. According to the VARC II criteria, the indication for TAVI was assessed by our interdisciplinary “heart team,” which consists of cardiologists, cardiac surgeons, internists, and radiologists.5,6 The endpoints were also based on the VARC II criteria for effectiveness.5 The primary endpoint was a combined efficacy endpoint after 1 year that included all-cause mortality after more than 30 days, failure of current therapy for Thoracic and Cardiovascular Surgeon

AS requiring hospitalization for symptoms of valve-related cardiac decompensation or prosthetic heart valve dysfunction (aortic valve area 30 d (n; %)

0 (0.00%)

2 (7.14%)

Failure of current therapy for AS (n; %)

3 (10.71%)

0 (0.00%)

Cardiovascular mortality (n; %)

0 (0.00%)

0 (0.00%)

Major stroke (n; %)

0 (0.00%)

0 (0.00%)

Life threatening or disabling and major bleeding (n; %)

0 (0.00%)

0 (0.00%)

Acute kidney injury (n; %)

1 (3.57%)

0 (0.00%)

Myocardial infarction (n; %)

0 (0.00%)

0 (0.00%)

Major vascular complications (n; %)

0 (0.00%)

0 (0.00%)

Prosthetic valve thrombosis (n; %)

0 (0.00%)

0 (0.00%)

Prosthetic valve endocarditis (n; %)

0 (0.00%)

1 (3.57%)

Conduction disturbances and cardiac arrhythmias (n; %)

0 (0.00%)

2 (7.14%)

Necessity of permanent pacemaker implantation (n; %)

0 (0.00%)

1 (3.57)

Clinically significant valve migration/dislocation (n; %)

0 (0.00%)

0 (0.00%)

Mechanical coronary obstruction (n; %)

0 (0.00%)

0 (0.00%)

with noncompliance of the patient’s medication intake. However, adaption of antihypertensive therapy led to recompensation in all of them. The echocardiographic follow-up confirmed the excellent results we already observed in our 30 days review. Regarding peak gradient, effective valve area, and velocity, all parameters were stable and showed good values after 3 and 12 months. An increase in effective valve area from mean 0.75
0.14 cm2 preoperatively to mean 1.84
0.57 cm2 after 12 months is favorable compared with the existent 1-year results after TA TAVI with the Edwards Sapien (from 0.6
0.2 cm2 to 1.6
0.5 cm2).7 The mean gradient after 12 months was 12.00
5.53 mm Hg in average, and thus comparable to previous studies (11.5
3.9 mm Hg), although we had the highest preoperative values in our study population (mean 49.43
18.44 mm Hg vs. 47.2
18.9 mm Hg, respectively).7

Moderate or severe aortic regurgitation after TAVI is associated with long-term mortality in patients undergoing TAVI.11–13 In our study, none of the patients was found to have moderate or severe aortic regurgitation after TAVI. Ensminger et al could show in an experimental in vitro study that no significant difference exists in regurgitation volume when implanting a JenaValve into a circular or eccentric annulus. This has a clinical impact when it is considered that the majority of the patients with AS have an eccentric aortic annulus. Suspected reasons for this behavior are the flexible stent design and the use of a complete native porcine root valve.14 The self-expanding nitinol stent technique, the feeler guided anatomically correct positioning of the JenaValve, and the clipping mechanism, which make the positioning and fixation of the prosthesis independent from any calcification of the native valve, may also be causative for the excellent results regarding paravalvular leakage. Thus, the JenaValve TAVI system is the only system indicated and CE approved for AS and aortic insufficiency.

Table 6 NYHA classification for dyspnea (n ¼ 21) Functional improvement assessment by NYHA functional classification

Fig. 4 Kaplan–Meier estimate regarding combined efficacy endpoint.

No improvement (n; %)

8 (38.1%)

Improvement of 1 category (n; %)

12 (57.14%)

Improvement of 2 categories (n; %)

1 (4.76%)

Deterioration of functional assessment (n; %)

0 (0.00%)

Abbreviation: NYHA, New York Heart Association. Thoracic and Cardiovascular Surgeon

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Within 3 mo

Transapical TAVI Using the JenaValve

Reuthebuch et al. while L. K. was predominantly in charge of the data management as part of his doctoral thesis. O. R. is proctor for JenaValve Technology GmbH, Munich, Germany. JenaValve Technology GmbH had once provided travel expenses for L. K.

References

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Fig. 5 New York Heart Association (NYHA) classification, preoperative and postoperative after 12 months. 3

Seiffert et al could already show lowest rates of pacemaker implantation in patients receiving a JenaValve compared with Engager and Symetis (14.8, 30, and 21%, respectively).9 Our data show even lower rates. After 1 year, two patients (7.14%) had a permanent pacemaker implantation. One patient with AV block grade 3 received a pacemaker in the 30-day period, and the other patient developed sick sinus syndrome 10 months after TAVI. Whether the causes for this are based on the design of the JenaValve, with its little stress on the annulus and the minimal amount of material in the left ventricular outflow tract, remains to be investigated.

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Conclusion Presenting the first midterm echocardiographic data of the second-generation transapical JenaValve TAVI system, we could show an excellent performance of the prosthesis after a midterm period regarding echocardiographic parameters such as transvalvular gradient, paravalvular leakage, and effective aortic valve area. Furthermore, clinical improvement was shown concerning NYHA classification pre- and postoperatively, as well as favorable secondary safety endpoints. In addition to the already published promising perioperative results, we could confirm the JenaValve TAVI system as a safe and feasible therapy for patients with severe AS. Further studies with larger numbers of patients are warranted to confirm these results.

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Study Limitations This is a nonrandomized, retrospective, single-center study. Because the study protocol was finalized at the end of the observation period, 3 months echocardiographic follow-up data are not complete in all patients. For better comparison, the figures include only patients of whom all values (preoperative, 3 and 12 months postoperative) were available.

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Authors’ Contribution O. R. and L. K. equally contributed to this article. O. R. has principally covered the clinical management of the patients Thoracic and Cardiovascular Surgeon

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