ABSTRACT: Percutaneous mitral valve repair (MVR) using MitraClip is an effective alternative treatment for patients with severe mitral valve insufficiency and high perioperative risk for surgery. Atrial fibrillation is frequent in patients needing MVR and some of these patients have contraindications for oral anticoagulation. Combining MitraClip implantation and occlusion of the left atrial appendage (LAA) may be of value in these patients with high thromboembolic risk. We report the first case of combined MitraClip procedure and percutaneous LAA closure in a single procedure.
J INVASIVE CARDIOL 2014;26(3):E32-E34
Key words: mitral valve repair, MitraClip
Percutaneous mitral valve repair (MVR) using MitraClip (Abbott Vascular) has been shown effective and safe in reducing mitral valve insufficiency and improving New York Heart Association functional class.1-4 Some studies proved safety and efficacy of this method in patients with increased risk for mitral valve surgery.1,3,5-7
Typically, patients with mitral valve regurgitation develop atrial fibrillation (AF). Some of the comorbidities leading to the high risk of cardiac surgery are equally associated with a high bleeding risk when oral anticoagulation is performed. The PROTECT AF study has demonstrated comparable efficacy of Watchman left atrial appendage (LAA) occluder and oral anticoagulation using warfarin in preventing cardiac embolic events and death of cardiovascular or unknown origin.8,9 In patients with the combination of a high risk for thromboembolic events and high risk for bleeding complications, LAA closure may prevent bleeding events by shortening the phase of necessary anticoagulation to the first weeks after implantation. Combining both procedures (percutaneous MVR and LAA occlusion) in such patients to minimize the timespan of elevated bleeding risk may be useful. We present the first report of such a combined procedure.
Case Report. A 57-year-old patient with preexisting dilative cardiomyopathy was transferred to our center because of severe mitral valve regurgitation, accompanied by permanent AF. Comorbidities included arterial hypertension and liver cirrhosis (Child Pugh score B) with esophageal varices. Transesophageal echocardiography (TEE) confirmed severe mitral valve insufficiency in segment 2 caused by ring dilatation and retraction of the posterior leaflet.
Because of the liver cirrhosis and severely reduced left ventricular ejection fraction (LVEF), there was a high perioperative risk10 for surgical MVR in this patient and we recommended MitraClip implantation. The patient had indication for long-term oral anticoagulation due to arterial hypertension, reduced LVEF, and mitral valve disease. Due to concomitant risk factors associated with a high risk for bleeding (HAS-BLED score 3), percutaneous LAA closure was also offered. We decided to perform both interventions in one procedure to minimize the period of anticoagulation.
The procedure was performed under general anesthesia in a hybrid operating theatre. Transseptal puncture was performed using SL1 sheath (St Jude Medical) and BRK-1 transseptal needle (St Jude Medical) guided by TEE aiming for a posterior position, which is even high enough to reach a good position for maneuvering the MitraClip delivery catheter. Directly after transseptal puncture, 10,000 units of unfractionated heparin were administered intravenously, and further boluses were given to maintain an activated clotting time of 300-350 s thereafter. Using a stiff guidewire inserted in the left superior pulmonary vein (LSPV), the 8 Fr SL1 sheath was removed and the 24 Fr MitraClip guide catheter and the delivery system were introduced into the LA. Through the guide catheter, the Clip delivery system was steered to segment two of the mitral orifice. Using live three-dimensional echocardiography, the clip was positioned and released as previously described.2 Placing a second MitraClip lateral to the first one was necessary to achieve an optimal result (Figure 1).
After removing the MitraClip delivery catheter and placing a stiff guidewire in the LSPV, the MitraClip guide catheter was replaced by a 30-cm long 24 Fr sheath (Edwards Lifesciences) inserted in the right femoral vein to obstruct the large puncture hole.
TEE and angiography of the LAA revealed 2 lobes. The ostial diameter was measured to be 21-23 mm in 0°, 45°, 90°, and 135° TEE views. Through the short sheath and over the guidewire, the Watchman Access System (Double Curve) was brought into the LSPV. Using a pigtail catheter introduced in the Access System, the last one was steered into the anterosuperior lobe of the LAA.
Thereafter, a 27 mm Watchman Delivery System was introduced into the LAA under fluoroscopic guidance. The device was deployed and released following check of all “release criteria.” TEE and control injection documented optimal position (Figures 2A and 2B). Sheaths were removed and the venous puncture site was closed by a cross stich.
Procedure time for MitraClip implantation (from puncture to release of the second clip) was 290 minutes, further time for Watchman Device implantation (from change of sheathes to final cross stich) was 30 minutes. Total fluoroscopy time was 26 minutes.
Prior to the intervention, the patient had been loaded with aspirin 100 mg and clopidogrel 300 mg. For the next 3 months, aspirin 100 mg plus clopidogrel 75 mg once daily was recommended. Follow-up at 8 weeks documented a good result with a small residual mitral valve insufficiency and a mean transmitral gradient of 4 mm Hg. The Watchman occluder was in optimal position without any residual flow or thrombus formation. The interatrial septum showed a small, not hemodynamically relevant left to right shunt as a residue of the 24 Fr transseptal sheath.
Discussion. In our report, we demonstrate the feasibility and effectiveness of combining percutaneous MVR using MitraClip plus LAA occlusion with the Watchman device in a patient with severe mitral valve insufficiency declined for surgical MVR. LAA occlusion was indicated on the basis of high thromboembolic risk combined with a high risk for bleeding complications under oral anticoagulants.
There are some arguments for a combined procedure in this setting. The period of early postinterventional antithrombocytic therapy could be shortened. Peri-interventional risks caused by transseptal puncture and large sheaths in femoral veins are minimized to one procedure. Additive effects of two septal defects after different large transseptal punctures may be avoided.
On the other hand, potential risks of a combined approach must also be weighed. Depending on the anatomy of the LAA, in some cases, the higher transseptal puncture site typically used for MitraClip implantation may be a handicap for LAA closure. Beyond this, care is necessary to prevent dislocation of the Pigtail catheter through the freshly clipped mitral valve. Procedure duration may be prolonged and simultaneous implantation of two different devices could increase the risk of thromboembolic events. In a prolonged procedure with continuous flushing of the sheaths, volume overload may occur. However, using the already existing transseptal puncture site for LAA occlusion, prolongation of the procedure by LAA closure should not be more than 30 minutes.
Optimal peri-interventional anticoagulation regimen after LAA closure remains unknown. The PROTECT AF study protocol consisting of warfarin and aspirin 100 mg for 45 days, followed by aspirin 100 mg and clopidogrel 75 mg until the 6-month follow-up exam, and aspirin alone thereafter8 was tested in patients without increased bleeding risk. In the ASAP registry, 6-month dual-thrombocyte inhibition was helpful to reduce strokes in patients with high bleeding risk and high thromboembolic risk, data on bleeding risk are not yet published.11 In our experience of more than 100 patients with high bleeding risk, shortening the phase of intense anticoagulation to 8 weeks (aspirin and half weight-adjusted dose of enoxaparin) followed by aspirin alone is safe after Watchman LAA closure. In the presented case, we recommended our typical scheme after MitraClip implantation consisting of aspirin 100 mg plus clopidogrel 75 mg for 12 weeks, followed by aspirin alone.
The combined procedure enabled us to shorten the phase of intense thrombocyte inhibition to 3 months.
Conclusion. In the setting of planned MitraClip implantation and AF, in patients with increased bleeding risk, a combined approach with implantation of MitraClip and Watchman Occluder in one procedure may be useful to shorten the period of intense anticoagulation therapy. With the presented case, we demonstrate the feasibility and efficacy of such a combined procedure. This technique should be reserved for selected patients with high bleeding risk. Further studies proving safety and mid-term efficacy are needed.
- Feldman T, Foster E, Glower DD, et al. Percutaneous repair or surgery for mitral regurgitation. N Engl J Med. 2011;364(15):1395-1406.
- Feldman T, Wasserman HS, Herrmann HC, et al. Percutaneous mitral valve repair using the edge to edge technique. Six-month results of the EVEREST phase I clinical trial. J Am Coll Cardiol. 2005;46(11):2134-2140.
- Franzen O, Baldus S, Rudolph V, et al. Acute outcomes of MitraClip therapy for mitral regurgitation in high-surgical-risk patients: emphasis on adverse valve morphology and severe left ventricular dysfunction. Eur Heart J. 2010;31(11):1373-1381.
- Maisano F, Franzen O, Baldus S, et al. MitraClip therapy demonstrates favorable mid-term outcomes in ACCESS-EUROPE heart failure patients with left ventricular ejection fraction 30%: preliminary report from the 6-month ACCESS-EU analysis cohort. EuroIntervention. 2011;7(Suppl M).
- Whitlow PL, Feldman T, Pedersen WR, et al. Acute and 12-month results with catheter-based mitral valve leaflet repair: the EVEREST II (Endovascular Valve Edge-to-Edge Repair) high risk study. J Am Coll Cardiol. 2012;59(2):130-139.
- Treede H, Schirmer J, Rudolph V, et al. A heart team’s perspective on interventional mitral valve repair: percutaneous clip implantation as an important adjunct to a surgical mitral valve program for treatment of high-risk patients. J Thorac Cardiovasc Surg. 2012;143(1):78-84.
- Rudolph V, Knap M, Franzen O, et al. Echocardiographic and clinical outcomes of MitraClip therapy in patients not amenable to surgery. J Am Coll Cardiol. 2011;58(21):2190-2195.
- Holmes DR, Reddy VY, Turi ZG, et al. Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: a randomized non-inferiority trial. Lancet. 2009;374(9689):534-542.
- Reddy VY, Holmes DR, Doshi SK, et al. Safety of percutaneous left atrial appendage closure results from the Watchman Left Atrial Appendage System for Embolic Protection in Patients With AF (PROTECT AF) clinical trial and the continued access registry. Circulation. 2011;123(4):417-424.
- Hayashida N, Aoyagi S. Cardiac operations in cirrhotic patients. Ann Thorac Cardiovasc Surg. 2004;10(3):140-147.
- Reddy VY, Möbius-Winkler S, Miller MA, et al. Left atrial appendage closure with the Watchman device in patients with a contraindication for oral anticoagulation: the ASAP study (ASA Plavix Feasibility Study With Watchman Left Atrial Appendage Closure Technology). J Am Coll Cardiol. 2013;61(25):2551-2556. Epub 2013 Apr 10.
From the Heart Center Bad Neustadt/Saale, Departments of 1Electrophysiology and 2Interventional Cardiology, Bad Neustadt/Saale, Germany.
Disclosure: The authors have completed and returned the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Schade works as a proctor for Boston Scientific, the producer of the Watchman Device. The remaining authors report no conflicts regarding the content herein.
Manuscript submitted June 17, 2013, provisional acceptance given August 15, 2013, final version accepted September 10, 2013.
Address for correspondence: Dr Anja Schade, Heart Center Bad Neustadt/Saale, Department for Electrophysiology, Salzburger Leite 1, 97616 Bad Neustadt/Saale. Email: email@example.com