Comparison of Outcome After Percutaneous Mitral Valve Repair With

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peptide levels, more tricuspid regurgitation, less often coronary artery .... Tricuspid regurgitation grade 4 ..... procedure be combined with mitral valvuloplasty?
Accepted Manuscript Title: Comparison of Outcome after Percutaneous Mitral Valve Repair with the MitraClip in Patients with Versus Without Atrial Fibrillation Author: Juliëtte F. Velu, Friso A. Kortlandt, Tom Hendriks, Remco A.J. Schurer, Ad J. van Boven, Karel T. Koch, M. Marije Vis, Jose P. Henriques, Jan J. Piek, Ben J.L. Van den Branden, Jeroen Schaap, Benno J. Rensing, Martin J. Swaans, Berto J. Bouma, Jan A.S. Van der Heyden, Jan Baan jr PII: DOI: Reference:

S0002-9149(17)31392-9 http://dx.doi.org/doi: 10.1016/j.amjcard.2017.08.022 AJC 22877

To appear in:

The American Journal of Cardiology

Received date: Accepted date:

8-6-2017 8-8-2017

Please cite this article as: Juliëtte F. Velu, Friso A. Kortlandt, Tom Hendriks, Remco A.J. Schurer, Ad J. van Boven, Karel T. Koch, M. Marije Vis, Jose P. Henriques, Jan J. Piek, Ben J.L. Van den Branden, Jeroen Schaap, Benno J. Rensing, Martin J. Swaans, Berto J. Bouma, Jan A.S. Van der Heyden, Jan Baan jr, Comparison of Outcome after Percutaneous Mitral Valve Repair with the MitraClip in Patients with Versus Without Atrial Fibrillation, The American Journal of Cardiology (2017), http://dx.doi.org/doi: 10.1016/j.amjcard.2017.08.022. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.

Comparison of Outcome After Percutaneous Mitral Valve Repair With the MitraClip in Patients With Versus Without Atrial Fibrillation

Juliëtte F. Velua MSc, Friso A. Kortlandtb MD, Tom Hendriksc MD, Remco A.J. Schurerc MD, Ad J. van Bovend MD PhD, Karel T. Kocha MD PhD, M. Marije Visa MD PhD, Jose P. Henriquesa MD PhD, Jan J. Pieka MD PhD, Ben J.L. Van den Brandene MD PhD, Jeroen Schaape MD PhD, Benno J. Rensingb MD PhD, Martin J. Swaansb MD PhD, Berto J. Boumaa MD PhD, Jan A.S. Van der Heydenb MD PhD, Jan Baan jra MD PhD

a

Department of Cardiology, Academic Medical Center, Amsterdam, The Netherlands b

Department of Cardiology, St. Antonius hospital, Nieuwegein, The Netherlands

c

Department of Cardiology, University Medical Center Groningen, Groningen, The Netherlands d

Department of Cardiology, Medical Center Leeuwarden, Leeuwarden, The Netherlands e

Department of Cardiology, Amphia hospital, Breda, The Netherlands

Address for correspondence: Corresponding author: Jan Baan jr Academic Medical Center, Department of Cardiology Meibergdreef 9 1105 AZ Amsterdam The Netherlands Phone: +31 20 566 6555 Fax: +31 20 696 2609 [email protected] Running head: Impact atrial fibrillation on MitraClip outcome Total word count: 2077 words Grant support and conflict of interest statement: J. Baan jr is proctor for Abbott Vascular MitraClip and receives an unrestricted research grant from Abbott Vascular. K.T. Koch is proctor for Abbott Vascular MitraClip. M. J. Swaans is proctor for Abbott Vascular MitraClip. J. A.S. Van der Heyden is proctor for Abbott Vascular MitraClip and Boston Lotus Valve. The other authors have no conflicts of interest to declare. 1

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Abstract Percutaneous mitral valve repair with the MitraClip is an established treatment for patients with mitral regurgitation (MR) who are inoperable or at high risk for surgery. Atrial Fibrillation (AF) frequently coincides with MR, but only scarce data of the influence of AF on outcome after MitraClip is available. The aim of the current study was to compare the clinical outcome after MitraClip treatment in patients with versus without atrial fibrillation. Between January 2009 and January 2016, all consecutive patients treated with a MitraClip in 5 Dutch centers were included. Outcome measures were survival, symptoms, mitral regurgitation grade and stroke incidence. In total, 618 patients were treated with a MitraClip. Patients with AF were older, had higher N-terminal B-type natriuretic peptide levels, more tricuspid regurgitation, less often coronary artery disease and a better left ventricular function. Survival of patients treated with the MitraClip was similar for patients with AF(82%) and non-AF(85%) after 1 year(p=0.30), but significantly different after 5 year follow-up (AF:34%;non-AF:47%; p=0.006). After 1 month, 64% of the patients with AF were in New York Heart Association (NYHA) class I or II, in contrast to 77% of the patients without AF (p=0.001). The stroke incidence appeared not to be significantly different (AF:1.8%;non-AF:1.0%; p=0.40). In conclusion, patients with AF had similar 1-year survival, MR reduction and stroke incidence compared to non-AF patients. However, MitraClip patients with AF had reduced long-term survival and remained more symptomatic compared to those without AF.

Keywords: atrial fibrillation; mitral regurgitation; percutaneous mitral valve repair; MitraClip.

2

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Percutaneous mitral valve repair with the MitraClip is an established treatment for patients with mitral regurgitation (MR) who are inoperable or at high risk for surgery.

1–3

Atrial Fibrillation (AF)

frequently coincides with MR. 4 AF is common in the general population, with a prevalence increasing with age. 5–7 Population-based studies indicate an impaired long-term survival and an increased risk of stroke in patients with AF compared to patients without AF. 8–11 In some studies, the outcome of surgical mitral valve repair in patients with AF was similar compared to patients without AF.

12,13

contrast to some surgical studies which reported a worse outcomes for patients with AF.

In

14–16

Conflicting results have also been reported about the impact of AF on the outcome of MitraClip implantation.

17–20

The aim of the current study was to compare in a large scale study the clinical

outcome after percutaneous mitral valve repair with the MitraClip in patients with versus without atrial fibrillation.

Methods Between January 2009 and January 2016, all 618 consecutive patients treated with a MitraClip in 5 Dutch centers were included. Preprocedural evaluation included: physical examination, electrocardiography, transthoracic echocardiography (TTE), transesophageal echocardiography (TEE) and laboratory measurements. Patients were judged in a heart team consisting of an interventional cardiologist, an imaging cardiologist and a cardiac surgeon. All patients had symptomatic MR and were rejected for surgery. Main exclusion criteria for MitraClip treatment were an unsuitable mitral valve anatomy or a life expectancy assessed as below 12 months due to severe comorbidities. 39 patients who did not receive a MitraClip during the implantation procedure were excluded from the analyses.

The MitraClip procedure has previously been described.

1,21

The procedure was performed

under general anesthesia, using fluoroscopic and transesophageal echocardiographic guidance. The 3

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results of MitraClip implantation were evaluated by TTE at discharge and during follow-up. All patients gave their written informed consent. The study complied with the ethical guidelines of the 1975 Declaration of Helsinki regarding investigation in humans.

The baseline characteristics of 618 patients were entered into the dedicated, prospective web-based database. All patients were invited for clinical evaluation and TTE at 1 month, 6 months and 12 months post MitraClip implantation. The stroke incidence was documented over the full follow-up period. Symptoms of dyspnea were quantified using the New York Heart Association (NYHA) classification. MR severity was graded as none, mild (1), moderate (2), moderate to severe (3) or severe (4) by experienced echocardiographers. Patients were followed until either their death, or until the 1st of March 2016.

Continuous variables were expressed as mean ± standard deviation (SD) or as median and interquartile range (IQR). Categorical variables were presented as absolute numbers and percentages. Survival was described using the Kaplan-Meier method. Multivariable Cox regression, using stepwise forward selection, was performed to analyze the association of clinical characteristics with survival, expressed as hazard ratio (HR) with 95% confidence interval (CI) and p-values. Confounders-adjusted logistic regression analysis was used for binary data and expressed as odds ratios with 95% CI and p-values. McNemar’s test was used to compare paired categorical data. Chi2testing was used to compare unpaired categorical data. An unpaired t-test was used to compare continuous variables when normally distributed and a Mann-Whitney U test when not normally distributed. Differences were considered statistically significant at p values