Assessment of the MitraClip Procedure: Reassessing the Goals

Abstract

Asher and colleagues1 present two interesting cases that not only highlight the use of MitraClip in the urgent setting, but also how intraoperative case management can help facilitate procedural success. Mitral valve disease is one of the most common valvular disorders with an incidence anywhere from 10% to 24%, most commonly affecting people older than 75 years.2,3 Primary mitral regurgitation (MR) is due to a structural or degenerative abnormality while secondary MR is related to left ventricular (LV) or less commonly left atrial disease. The choice of treatment varies based on the underlying cause and progression of the disease. In the case of severe primary MR, patients who are either symptomatic or asymptomatic but have LV systolic dysfunction should undergo surgical intervention, and repair is recommended in preference to replacement if possible.4 The central double orifice technique, also known as the Alfieri technique, can be used to repair degenerative MR lesions and has been shown to be very effective in reducing MR and improving survivability.5,6 The MitraClip (Abbott, Abbott IL) is a mechanical device that was developed for percutaneous transcatheter mitral valve repair, reproducing the double-orifice technique.7,8 As the authors of this case conference mentioned, the MitraClip gained FDA approval in 2013 for patients with primary MR, severe symptoms, and prohibitive or high surgical risk.8 When compared to a conventional surgical approach, percutaneous repair was reported to be less effective at reducing MR, but was associated with less major adverse events at 30 days, and better improvement in symptoms and quality of life.7 Interestingly, several registries corroborate this finding, showing a better safety profile and improved quality of life despite an inferior reduction in the severity of MR.9,10 This led to an expansion of indications, and several landmark studies have been conducted to compare the use of MitraClip to medical therapy and surgery in patients with secondary MR. The COAPT Trial11 conducted by Stone et. al studied patients with moderate to severe secondary MR and heart failure and found that the use of percutaneous mitral valve repair resulted in a lower rate of hospitalization for heart failure and lower all-cause mortality within 24 months as compared to only medical therapy. In contrast, in the MITRA-FR trial12, Obadia et. al studied patients with severe secondary MR and found that the rate of death or hospitalization for heart failure at 1 year did not differ between percutaneous mitral valve repair along with medical therapy versus those who only received medical therapy. In contrast to the aforementioned trial comparing MitraClip with conventional surgery, the COAPT trial showed better outcomes in terms of reduction of MR, which they attributed to increased experience with the device and better echocardiographic guidance11. A common thread among all of these studies is that patient selection for the MitraClip procedure requires careful and thorough patient evaluation and communication among all providers involved in a patient's care, spanning multiple specialties. The 2020 American College of Cardiology and American Heart Association guidelines explicitly state that patients can be considered for MitraClip surgery if they are deemed to be inoperable or high surgical risk by a heart team who have particular expertise in valvular heart disease and include cardiologists, cardiac surgeons, imaging specialists, anesthetists, and if needed, general practitioners, geriatricians, or intensive care specialists4. The role of echocardiography is also essential not only during the procedure, as was discussed by the authors of this case conference, but also as part of the preprocedural evaluation process. Preprocedural echocardiographic assessment includes grading of MR severity and determination of morphology. MR severity can be graded using qualitative measurements (observation of morphology, observation of a color jet, continuous wave doppler signal of an MR jet), semi-quantitative measurements (vena contracta width, pulmonary vein inflow, mitral inflow, left atrial or LV size), and quantitative measurements (regurgitant volume, regurgitant fraction, and effective regurgitant orifice area).13 Ideal valve morphology for a MitraClip procedure consists of MR originating from the midportion of the valve, lack of calcification in the grasping area, mitral valve area <4cm2, length of the posterior leaflet ≥ 10 mm, no rheumatic disease or endocarditis, flail width <15 mm, flail-gap <10 mm, and coaptation depth <11 mm and coaptation length >2 mm which would provide sufficient leaflet tissue for grasping.13 Two key studies in the history of the MitraClip, the EVEREST trials7,14, only included patients that met strict echocardiographic criteria. However, the desire to expand indications led to studies such as that conducted by Attizzani et. al, who compared patients who met selective echocardiographic criteria with a group with expanded criteria and found similar rates of safety and efficacy through 12-month follow up.15 Notably, this study also showed marked improvement in MR severity that was comparable between the two groups regardless of baseline echocardiographic characteristics15, which is encouraging and certainly helps to make the case for expanding indications for this procedure. Franzen et. al performed a prospective study on patients deemed to be high surgical risk, many (69%) of whom also had “adverse MV morphology” by echocardiography and found that the procedure was feasible in this group of patients with 96% procedural success, which was classified as a reduction in MR severity, improved functional capacity at discharge, with none to minor periprocedural complications.16 A common theme seen in the literature surrounding percutaneous or minimally invasive cardiac procedures is the desire to push the envelope- to improve the technology, expand the indications, and increase the eligible surgical population. In this case conference, the authors describe two cases where pushing the envelope consists of performing the MitraClip procedure in an urgent or emergent setting, where the patients are presumably more ill, decompensated, and have not had the time for the thorough evaluation previously deemed necessary thus obliviating any possibility of stringent inclusion criteria. These patients, many of whom are in cardiogenic shock, often maxed out on medical therapy and are not candidates for surgical or advanced mechanical circulatory support have no recourse when it comes to further treatment for their condition. Until recently, the use of MitraClip in the ‘rescue’ setting was limited to case reports, although with overall positive results.17,18 This led to a few, very small single-center studies which showed that while certainly not without risk, the use of MitraClip could be ‘reasonable’ in this patient population.19,20 In most of these cases there was an immediate reduction in MR severity and improvement in functional status at 30 days, but still significant 30 day and 1 year mortality19. Jung et. al performed a multicenter, patient-level analysis to evaluate outcomes (short and intermediate term mortality, length of hospital stay and readmission for heart failure exacerbation, and comparison of outcomes stratified by device success) of patients with cardiogenic shock and severe MR who underwent transcatheter mitral valve repair and found improved short and intermediate term mortality and less readmission for heart failure21. The authors cite two single-center, retrospective studies evaluating for outcomes in the urgent or emergent setting and find that while the procedure can certainly be performed, there Is an unsurprisingly high rate of post procedural complications and high short-term mortality.22,23. It is clear that the procedure is feasible and presents an option for patients who otherwise have none, and thus the authors of this case conference have identified a critical opportunity for further high-quality studies. While it is exciting to think of the opportunities for offering this procedure to a greater expanding patient population, it is important to consider the risks and complications, some of which are detailed in this case conference. Complications can largely be divided into procedure-related and device-related. Procedure-related complications tend to arise as a result of the vascular access needed for the device and the transseptal puncture, which is performed to access the mitral valve. Placement of the MitraClip device requires a 24Fr venous sheath, which can result in several short and long term vascular complications such as: dissection, stenosis, perforation, rupture, pseudoaneurysm, and hematoma. Reported rates of vascular complications range from 1.4-4% for major complications, and 2.7-3.8% for minor complications.9,24,25 Along with vascular complications, bleeding is another common adverse event seen after transcatheter mitral valve repair and has been found to be an independent predictor for in-hospital mortality.26,27 Thromboembolic events can occur as a result of mishandling of the catheters (not flushing catheter, inadequate device preparation) as well as from the thrombogenic nature of the catheters themselves. Fortunately, the incidence of postprocedural embolism, particularly cerebrovascular events, are low, and is certainly lower than in the surgical population.26 The main procedure associated cardiac complications are pericardial effusion/tamponade and persistent iatrogenic atrial septal defect. Rates of pericardial effusion have been decreasing over the years, likely due to increased operator experience as well as the use of 3-D transesophageal echocardiography (TEE) to provide better guidance for transseptal puncture.26 Device-related complications include: persistent MR, mitral stenosis (MS), partial clip detachment, clip embolization, and leaflet injury or chordae rupture. Persistent MR after MitraClip is an outcome well-studied in the literature, as it is an important prognostic factor for morbidity and mortality. It appears that newer generation (‘G4’) devices have shown excellent results in reducing postprocedural MR.24,26 Like many medical devices, optimizing outcomes often depends on operators experience with the device, as well as choosing the best approach based on the patient's specific valvular pathology. Unsurprisingly, MS is associated with worse long-term outcomes and high mortality.26,28 Many of the cited predictors of post-clip implantation MS are related to the pre-procedural echo measurements (mitral valve area), thus it would be hard to predict the rate of MS in the urgent/emergent setting. Partial clip detachment, or single leaflet device attachment is the most common device failure and occurs more often in complex valvular pathology.26 It occurs most commonly in the acute setting, and often in the setting of inadequate leaflet grasping, although clip detachment in the setting of adequate leaflet grasping may raise the concern for a leaflet tear. Beyond operator experience, excellent TEE guidance will help to reduce this complication as constant visualization during both positioning and leaflet grasping can help avoid asymmetric or inadequate leaflet grasping, both which can lead to detachment. Clip detachment often results in recurrence or event worsening of MR, and thus should be fixed immediately upon recognition. Leaflet injury, which has a reported incidence of about 0-2%, is commonly seen in patients who have persistent MR after clip implantation.24,26,29 This is a difficult complication to remedy and should be avoided if at all possible by ensuring proper clip positioning and deployment. In the first case described in the case conference, attempts to deploy a second clip results in leaflet trauma, subsequent severe MR, cardiogenic shock, and likely contributed to the patient's ultimate demise. The authors of this case conference present two cases of urgent/emergent MitraClip implantation and describe how both intraoperative management and expert echocardiographic skills can help facilitate a successful procedure in a patient group already at risk for high morbidity and mortality. Not only is clear communication across all team members crucial in these situations, but collaborative thinking as to what measures can be employed to facilitate a successful procedure is also very important. The lessons learned from this case conference as well as the opportunity for more research into how to best perform this procedure in the urgent and emergent setting will help to both mitigate the complications and ensure procedural success. Asher S, Maslow A, Black R. Assessment of MitraClip procedure: Reassessing the goals. Journal of Cardiovascular Anesthesia. In pressNkomo VT, Gardin JM, Skelton TN, Gottdiener JS, Scott CG, Enriquez-Sarano M. Burden of valvular heart diseases: a population-based study. Lancet. Sep 16 2006;368(9540):1005-11. doi:10.1016/S0140-6736(06)69208-8Andell P, Li X, Martinsson A, et al. Epidemiology of valvular heart disease in a Swedish nationwide hospital-based register study. Heart. Nov 2017;103(21):1696-1703. doi:10.1136/heartjnl-2016-310894Otto CM, Nishimura RA, Bonow RO, et al. 2020 ACC/AHA Guideline for the management of patients with valvular heart disease: executive summary: A report of the American College of Cardiology/American Heart Association joint committee on clinical practice guidelines. Circulation. Feb 2 2021;143(5):e35-e71. doi:10.1161/CIR.0000000000000932Alfieri O, Maisano F, De Bonis M, et al. The double-orifice technique in mitral valve repair: a simple solution for complex problems. J Thorac Cardiovasc Surg. Oct 2001;122(4):674-81. doi:10.1067/mtc.2001.117277Maisano F, Vigano G, Blasio A, Colombo A, Calabrese C, Alfieri O. Surgical isolated edge-to-edge mitral valve repair without annuloplasty: clinical proof of the principle for an endovascular approach. EuroIntervention. Aug 2006;2(2):181-6.Feldman T, Foster E, Glower DD, et al. Percutaneous repair or surgery for mitral regurgitation. N Engl J Med. Apr 14 2011;364(15):1395-406. doi:10.1056/NEJMoa1009355Nishimura RA, Vahanian A, Eleid MF, Mack MJ. Mitral valve disease–current management and future challenges. Lancet. Mar 26 2016;387(10025):1324-34. doi:10.1016/S0140-6736(16)00558-4Eggebrecht H, Schelle S, Puls M, et al. Risk and outcomes of complications during and after MitraClip implantation: Experience in 828 patients from the German TRAnscatheter mitral valve interventions (TRAMI) registry. Catheter Cardiovasc Interv. Oct 2015;86(4):728-35. doi:10.1002/ccd.25838Nickenig G, Estevez-Loureiro R, Franzen O, et al. Percutaneous mitral valve edge-to-edge repair: in-hospital results and 1-year follow-up of 628 patients of the 2011-2012 Pilot European Sentinel Registry. J Am Coll Cardiol. Sep 2 2014;64(9):875-84. doi:10.1016/j.jacc.2014.06.1166Stone GW, Lindenfeld J, Abraham WT, et al. Transcatheter mitral-valve repair in patients with heart failure. N Engl J Med. Dec 13 2018;379(24):2307-2318. doi:10.1056/NEJMoa1806640Obadia JF, Messika-Zeitoun D, Leurent G, et al. Percutaneous repair or medical treatment for secondary mitral regurgitation. N Engl J Med. Dec 13 2018;379(24):2297-2306. doi:10.1056/NEJMoa1805374Wunderlich NC, Siegel RJ. Peri-interventional echo assessment for the MitraClip procedure. Eur Heart J Cardiovasc Imaging. Oct 2013;14(10):935-49. doi:10.1093/ehjci/jet060Feldman T, Kar S, Rinaldi M, et al. Percutaneous mitral repair with the MitraClip system: safety and midterm durability in the initial EVEREST (Endovascular Valve Edge-to-Edge REpair Study) cohort. J Am Coll Cardiol. Aug 18 2009;54(8):686-94. doi:10.1016/j.jacc.2009.03.077Attizzani GF, Ohno Y, Capodanno D, et al. Extended use of percutaneous edge-to-edge mitral valve repair beyond EVEREST (Endovascular Valve Edge-to-Edge Repair) criteria: 30-day and 12-month clinical and echocardiographic outcomes from the GRASP (Getting Reduction of Mitral Insufficiency by Percutaneous Clip Implantation) registry. JACC Cardiovasc Interv. Jan 2015;8(1 Pt A):74-82. doi:10.1016/j.jcin.2014.07.024Franzen 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. Jun 2010;31(11):1373-81. doi:10.1093/eurheartj/ehq050Couture P, Cloutier-Gill LA, Ducharme A, Bonan R, Asgar AW. MitraClip intervention as rescue therapy in cardiogenic shock: one-year follow-up. Can J Cardiol. Sep 2014;30(9):1108 e15-6. doi:10.1016/j.cjca.2014.03.045Zuern CS, Schreieck J, Weig HJ, Gawaz M, May AE. Percutaneous mitral valve repair using the MitraClip in acute cardiogenic shock. Clin Res Cardiol. Aug 2011;100(8):719-21. doi:10.1007/s00392-011-0324-1Medvedovsky, A. T., Tonchev, I., Tahiroglu, I., Lotan, C., Gilon, D., Planer, D., ... & Shuvy, M. (2019). MitraClip therapy in critically Ill patients with severe functional mitral regurgitation and refractory heart failure. Structural Heart, 3(4), 296-30Pleger ST, Chorianopoulos E, Krumsdorf U, Katus HA, Bekeredjian R. Percutaneous edge-to-edge repair of mitral regurgitation as a bail-out strategy in critically ill patients. J Invasive Cardiol. Feb 2013;25(2):69-72.Jung RG, Simard T, Kovach C, et al. Transcatheter mitral valve repair in cardiogenic shock and mitral regurgitation: A patient-level, multicenter analysis. JACC Cardiovasc Interv. Jan 11 2021;14(1):1-11. doi:10.1016/j.jcin.2020.08.037Kovach CP, Bell S, Kataruka A, Reisman M, Don C. Outcomes of urgent/emergent transcatheter mitral valve repair (MitraClip): A single center experience. Catheter Cardiovasc Interv. Feb 15 2021;97(3):E402-E410. doi:10.1002/ccd.29084Musuku SR, Mustafa M, Pulavarthi M, et al. Procedural, short-term, and intermediate-term outcomes in propensity-matched patients with severe mitral valve regurgitation undergoing urgent versus elective MitraClip percutaneous mitral valve repair. J Cardiothorac Vasc Anesth. May 2022;36(5):1268-1275. doi:10.1053/j.jvca.2021.12.008Praz F, Braun D, Unterhuber M, et al. Edge-to-edge mitral valve repair with extended clip arms: early experience from a multicenter observational study. JACC Cardiovasc Interv. Jul 22 2019;12(14):1356-1365. doi:10.1016/j.jcin.2019.03.023Sorajja P, Vemulapalli S, Feldman T, et al. Outcomes with transcatheter mitral valve repair in the United States: An STS/ACC TVT Registry Report. J Am Coll Cardiol. Nov 7 2017;70(19):2315-2327. doi:10.1016/j.jacc.2017.09.015Schnitzler K, Hell M, Geyer M, Kreidel F, Munzel T, von Bardeleben RS. Complications following MitraClip implantation. Curr Cardiol Rep. Aug 13 2021;23(9):131. doi:10.1007/s11886-021-01553-9von Bardeleben RS, Hobohm L, Kreidel F, et al. Incidence and in-hospital safety outcomes of patients undergoing percutaneous mitral valve edge-to-edge repair using MitraClip: five-year German national patient sample including 13,575 implants. EuroIntervention. Apr 20 2019;14(17):1725-1732. doi:10.4244/EIJ-D-18-00961Neuss M, Schau T, Isotani A, Pilz M, Schopp M, Butter C. Elevated mitral valve pressure gradient after MitraClip implantation deteriorates long-term outcome in patients with severe mitral regurgitation and severe heart failure. JACC Cardiovasc Interv. May 8 2017;10(9):931-939. doi:10.1016/j.jcin.2016.12.280Chakravarty T, Makar M, Patel D, et al. Transcatheter edge-to-edge mitral valve repair with the MitraClip G4 System. JACC Cardiovasc Interv. Oct 26 2020;13(20):2402-2414. doi:10.1016/j.jcin.2020.06.053 The author declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. Assessment of the MitraClip Procedure: Reassessing the GoalsJournal of Cardiothoracic and Vascular AnesthesiaPreviewTHE MITRACLIP (Abbott Laboratories) was first implanted in 2003, was approved in Europe in 2008, and approved by the US Food and Drug Administration in 2013. The MitraClip procedure has reduced hospitalization and mortality compared to medical therapy, with either improved or similar outcomes compared with isolated mitral valve surgery.1-3 In the earlier and preliminary data, proponents of surgery highlighted less mitral regurgitation (MR) and fewer additional procedures after surgical correction of MR; however, the overall major cardiac adverse events were significantly lower (15% v 48%) for percutaneous procedures. Full-Text PDF