Combined percutaneous balloon mitral valvuloplasty and left atrial appendage occlusion device implantation for rheumatic mitral stenosis and atrial fibrillation

Combined percutaneous balloon mitral valvuloplasty and left atrial appendage occlusion device implantation for rheumatic mitral stenosis and atrial fibrillation

    Combined Percutaneous Balloon Mitral Valvuloplasty and Left Atrial Appendage occlusion device implantation for Rheumatic Mitral Steno...

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    Combined Percutaneous Balloon Mitral Valvuloplasty and Left Atrial Appendage occlusion device implantation for Rheumatic Mitral Stenosis and Atrial Fibrillation Dale Murdoch, Laura McAulay, Darren L. Walters PII: DOI: Reference:

S1553-8389(14)00134-1 doi: 10.1016/j.carrev.2014.04.007 CARREV 652

To appear in:

Cardiovascular Revascularization Medicine

Received date: Revised date: Accepted date:

16 March 2014 13 April 2014 14 April 2014

Please cite this article as: Murdoch Dale, McAulay Laura, Walters Darren L., Combined Percutaneous Balloon Mitral Valvuloplasty and Left Atrial Appendage occlusion device implantation for Rheumatic Mitral Stenosis and Atrial Fibrillation, Cardiovascular Revascularization Medicine (2014), doi: 10.1016/j.carrev.2014.04.007

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ACCEPTED MANUSCRIPT Title Page Combined Percutaneous Balloon Mitral Valvuloplasty and Left Atrial Appendage

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occlusion device implantation for Rheumatic Mitral Stenosis and Atrial Fibrillation

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Dale Murdoch,1,2* MBBS FRACP, Laura McAulay,1 MBBS and Darren L Walters,1,2 MBBS MPhil FRACP FSCAI

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1. The Prince Charles Hospital, Brisbane, Australia 2. The University of Queensland, Brisbane, Australia

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Correspondence

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Indexing words

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Dr Dale Murdoch Cardiology Department The Prince Charles Hospital Rode Rd, Chermside QLD 4032 [email protected]

Rheumatic heart disease

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Thromboembolism Anticoagulation Watchman® Short title

Mitral valvuloplasty and LAA occluder for RHD

Word Count Abstract:

126 words

Manuscript:

1182 words

ACCEPTED MANUSCRIPT Abstract:

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Rheumatic heart disease is a common cause of cardiovascular morbidity and mortality worldwide, mostly in developing countries. Mitral stenosis and atrial fibrillation often coexist, related to both structural and inflammatory changes of

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the mitral valve and left atrium. Both predispose to left atrial thrombus formation, commonly involving the left atrial appendage. Thromboembolism can

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occur, with devastating consequences. We report the case of a 62 year old

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woman with rheumatic heart disease resulting in mitral stenosis and atrial fibrillation. Previous treatment with warfarin resulted in life-threatening

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gastrointestinal bleeding and she refused further anticoagulant therapy. A combined procedure was performed, including percutaneous balloon mitral valvuloplasty and left atrial appendage occlusion device implantation with the

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Atritech® Watchman® device. No thromboembolic or bleeding complications were encountered at one year follow-up. Long-term follow-up in a cohort of

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patients will be required to evaluate the safety and efficacy of this strategy.

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INTRODUCTION

Rheumatic heart disease is a common cause of cardiovascular morbidity and mortality worldwide, mostly in developing countries. Mitral stenosis is a

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common consequence, causing disabling symptoms when severe. Atrial fibrillation also occurs, both as a result of atrial hypertension and dilation related

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to mitral stenosis, and persistent rheumatic inflammation and fibrosis. Patients

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are strongly predisposed to atrial thrombus formation and subsequent thromboembolic stroke and systemic embolism. Anticoagulation with a vitamin

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K antagonist is effective in reducing thromboembolism, but alternate management strategies are required in patients with contraindications to

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anticoagulation.

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CASE REPORT

A 62 year old female with longstanding rheumatic heart disease and mixed mitral valve pathology (predominantly stenosis) and concomitant atrial fibrillation (AF) presented with progressive dyspnea (NYHA Class III) and decreased exercise tolerance. Anticoagulant therapy was contraindicated due to previous life-threatening gastrointestinal bleeding on warfarin and the patient was subsequently treated with Aspirin 100mg daily. Physical examination revealed an irregular pulse, rate 70 bpm and BP 120/70mmHg. Pan systolic and mid-diastolic murmurs were present. 12-lead ECG demonstrated atrial fibrillation.

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3-dimensional transoesophageal echocardiogram (3D-TOE) showed a rheumatic

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mitral valve with moderately severe mitral stenosis (MPG 9mmHg and MVA 0.8cm2 by planimetry) and 2/4 mitral regurgitation. (Figure 1) Wilkins’ score for mitral stenosis was 8/16. Other findings included 2/4 tricuspid regurgitation

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and a left atrial appendage with characteristics which appeared suitable for

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device closure.

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Given the high risk of stroke related to valvular atrial fibrillation in the setting of rheumatic valve disease, anticoagulation therapy with warfarin was once again

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recommended, but the patient refused. Anticoagulation with one of the novel oral anticoagulant medications was considered, but not chosen because a) use in valvular atrial fibrillation is not studied and is therefore off-label and b) the risk

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of major gastrointestinal bleeding is similar to that of warfarin. Therefore combined percutaneous balloon mitral valvuloplasty and LAA occlusion were

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considered appropriate for this patient.

Under general anesthesia, arterial and venous sheaths were placed in the right groin. A Brockenbrough needle (St. Jude, Inc., Minneapolis, USA) was used to puncture the interatrial septum under both fluoroscopic and echocardiographic guidance (Figure 2). Transseptal puncture was performed in the mid to lower part of the posterior interatrial septum, which is ideal for LAA occluder device implantation. Multiple dilations of the mitral valve were performed with a 28mm Toray Inoue-balloon catheter (Toray Medical Co., Tokyo, Japan), inflated to 25cc,

ACCEPTED MANUSCRIPT resulting in the reduction of mean transmitral pressure gradient to 6mmHg, with

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no increase of mitral regurgitation. (Figure 3).

After mitral valvuloplasty was completed, the Inoue-balloon catheter was exchanged for an SL1 catheter (St. Jude, Inc., Minneapolis, USA), through which

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an 0.035in Amplatz super-stiff guide wire (Boston Scientific, Natick, USA) was placed into the left upper pulmonary vein. Subsequently a 14Fr single-curve

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delivery sheath was passed over the wire, with a 6Fr pigtail catheter delivered

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into the left atrium. (Figure 4) The left atrial appendage was then sized via both TOE and fluoroscopy; with an ostium of 17.7mm diameter. A 21mm Watchman®

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left atrial appendage (LAA) occluder device (Atritech, Inc., Plymouth, USA) was chosen. Prior to device deployment, the delivery sheath position was confirmed with contrast injection. Once deployed, the stability and positioning of the device

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were confirmed with the tug test and injection of contrast. Once disconnected, the device position and seal were again confirmed using both contrast injection

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and colour flow Doppler TOE imaging.

The patient was initiated on daily aspirin 100mg and clopidogrel 75mg and monitored in the coronary care unit post procedure. A transthoracic echocardiogram performed day one post procedure showed moderate mitral stenosis with MPG 7mmHG, 1-2/4 MR, a well seated watchman LAA occluder device and trivial pericardial fluid. A TOE performed on day 45 post procedure also showed moderate mitral stenosis with a well seated watchman device with no intra-device flow.

ACCEPTED MANUSCRIPT At six month follow-up the patient exhibited a significant symptomatic improvement, with complete resolution of dyspnoea. There were no bleeding

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complications during the 6 months of dual antiplatelet therapy and this was reduced to single agent Aspirin 100mg daily. No stroke or systemic embolism

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occurred in follow-up at one year.

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DISCUSSION

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Patients with both mitral stenosis and atrial fibrillation as a result of rheumatic heart disease have increased risk of thromboembolic stroke and systemic

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embolism compared to those with non-valvular AF (1). Left atrial thrombus is observed over 30% of patients and occurs in both the left atrial appendage and the body of the left atrium(2,3). Without anticoagulation, annual risk of

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thromboembolism is 17-18%(4). Importantly, traditional risk estimating tools such as CHADS2 and CHA2DS2-VASc do not apply to patients with rheumatic

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atrial fibrillation(5,6).

Anticoagulation with warfarin is recommended, with a target international normalized ratio (INR) of 2.5 – 3.5 for patients with rheumatic mitral stenosis and 3.0 – 4.0 for patients with a mechanical mitral valve prosthesis (4). Large trials of the novel oral anticoagulants have excluded patients with rheumatic/valvular atrial fibrillation and they are not currently indicated. In fact, a massive left atrial thrombus has been reported in a patient with rheumatic mitral stenosis and atrial fibrillation whilst anticoagulated with dabigatran (Pradaxa®)(7).

ACCEPTED MANUSCRIPT The combined procedure we have described may reduce the risk of stroke and systemic embolism by more than one mechanism. First, occlusion of the left

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atrial appendage with the Watchman® LAA occluder prevents thrombus formation within the appendage. Thrombus forms within the LAA in more than 50% of patients with rheumatic atrial fibrillation(3). In the PROTECT-AF study,

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the WATCHMAN LAA occluder device was shown to be non-inferior to warfarin in preventing stroke and systemic embolism in patients with non-valvular AF(8).

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Second, treatment of mitral stenosis with balloon mitral valvuloplasty may help

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to reduce the thrombotic risk. Relief of mitral stenosis reduces stasis within the left atrium(9) and may prevent left atrial enlargement, which is a risk factor for

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thromboembolism(4). In addition, mitral stenosis causes a hypercoagulable state which is likely to contribute to thrombus formation and embolism, and balloon

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mitral valvuloplasty has been shown to reduce this hypercoagulable state(10).

Technical considerations for combining these two procedures are important. The

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location of the transseptal puncture is vital for placement of the LAA occluder device, and thus this takes priority. The mid to lower part of the posterior interatrial septum is considered ideal, although this may make the balloon mitral valvuloplasty more challenging in some patients. The exchange procedure also requires careful consideration. An SL1 guiding catheter was used to maintain position in the left atrium whilst exchanging the Inoue-balloon catheter for a stiff wire. This allows delivery of the 14-Fr delivery sheath and routine implantation of the Watchman LAA occluder device.

ACCEPTED MANUSCRIPT Further evaluation of this strategy in a larger number of patients with long term follow-up is required. A cohort study reporting procedural safety, bleeding and

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embolic events would provide further useful information.

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CONCLUSION

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We present a case of a combined procedure to reduce mitral stenosis and prevent thromboembolism in a patient with rheumatic heart disease, atrial

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fibrillation and contraindication to warfarin. Patients with rheumatic atrial fibrillation are at high risk of thromboembolism, and warfarin is first line therapy. Novel oral anticoagulants are untested and may be ineffective.

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Combined mitral valvuloplasty and LAA occluder device therapy should be considered in the rare instance where a patient has an indication for both

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procedures, although the long term efficacy of this approach is yet to be determined.

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Figure Legend

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Figure 1. A 3-dimensional transesophageal echocardiographic (TEE) image of

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the stenotic mitral valve. Mitral valve area by planimetry was 0.8cm2.

Figure 2. A TEE image of the Brockenbrough needle ‘tenting’ the interatrial

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septum (arrow), prior to transseptal puncture.

Figure 3. Fluoroscopic (left) and TEE (right) images of the inflated 28mm Toray Inoue-balloon catheter.

Figure 4. The exchange procedure. After balloon mitral valvuloplasty, the Inoueballoon catheter was exchanged for an SL1 catheter (A). Via the SL1 catheter, an 0.035in extra support wire was placed into the left upper pulmonary vein (B). Subsequently, a 14 Fr single-curve delivery catheter was passed over the wire

ACCEPTED MANUSCRIPT (C). Finally, a 6 Fr pigtail catheter was delivered into the left atrium so that the

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left atrial appendage could be imaged (D).

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3. Blackshear JL,Odell JA. Appendage obliteration to reduce stroke in cardiac surgical patients with atrial fibrillation. Ann Thorac Surg. 1996;61:755 759.

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ACCEPTED MANUSCRIPT 6. Lip GY, Nieuwlaat R, Pisters R, Lane DA, Crijns HJGM. Refining clinical risk stratification for predicting stroke and thromboembolism in atrial

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