MitraClip device for patients with severe mitral valve regurgitation: a rapid health technology assessment_Chinese Journal of Evidence-Based Medicine

Authors：

FAN Zhilei ^1,2 , LIAN Dai ^1,2 , YUAN Jiaqi ^1,2 , WENG Junling ^1,2 , WEI Yan ^1,2 ,  CHEN Yingyao ^1,2

1. School of Public Health, Fudan University, Shanghai 200032, P. R. China;
2. National Health Commission Key Laboratory of Health Technology Assessment, Fudan University, Shanghai 200032, P. R. China;

Corresponding author：

CHEN Yingyao, Email: yychen@shmu.edu.cn

Keywords：

MitraClip; Mitral regurgitation; Transcatheter edge-to-edge repair; Health technology assessment

DOI：

10.7507/1672-2531.202207131

Video：

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Objective To utilize a rapid health technology assessment to evaluate the efficacy, safety and cost-effectiveness of the MitraClip device for patients with severe mitral regurgitation (MR). Methods PubMed, EMbase, The Cochrane Library, CNKI, WanFang Data, CBM and the CRD databases were electronically searched to collect clinical evidence and economic evaluations on the efficacy, safety and cost-effectiveness of the MitraClip device for patients with severe MR from inception to May 2022. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies; then, descriptive analyses and data summaries were performed. Results A total of 33 studies, involving 4 HTA reports, 3 RCTs, 16 systematic reviews or meta-analyses, and 10 economic evaluations were included. In the evidence comparing MitraClip and surgery, most of the literature showed that the MitraClip group had higher postoperative residual MR, fewer blood transfusion events, and fewer hospital days. We found no significant treatment effects on 30-day adverse events and mortality, and the 1-year and above survival rate. In the evidence of MitraClip versus medical therapy alone, all included studies showed that MitraClip benefited mid-term and long-term survival and reduced the incidence of subsequent cardiac hospitalizations. Economic evaluations showed that the clinical benefits were cost-effective in the setting of their health service systems. Conclusion The available high-grade clinical evidence shows that MitraClip is effective and safe to some extent, and has cost-effectiveness compared with traditional treatment in other countries. However, the real-world effectiveness and cost-effectiveness of the MitraClip need to be tested in the Chinese population and health-care setting.

Citation： FAN Zhilei, LIAN Dai, YUAN Jiaqi, WENG Junling, WEI Yan, CHEN Yingyao. MitraClip device for patients with severe mitral valve regurgitation: a rapid health technology assessment. Chinese Journal of Evidence-Based Medicine, 2023, 23(1): 41-49. doi: 10.7507/1672-2531.202207131 Copy

1.	Zhou M, Wang H, Zeng X, et al. Mortality, morbidity, and risk factors in China and its provinces, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet, 2019, 394(10204): 1145-1158.
2.	Hu P, Liu XB, Liang J, et al. A hospital-based survey of patients with severe valvular heart disease in China. Int J Cardiol, 2017, 231: 244-247.
3.	叶蕴青, 许海燕, 李喆, 等. 中国不同区域老年瓣膜性心脏病构成和病因分析. 中华老年心脑血管病杂志, 2019, 21(7): 676-682.
4.	潘文志, 周达新, 葛均波. 中国二尖瓣反流患者人群数量的估测. 中国胸心血管外科临床杂志, 2021, 28(5): 495-498.
5.	潘翠珍, 潘文志, 李伟, 等. 二尖瓣解剖结构及反流的超声心动图新评价. 中华超声影像学杂志, 2020, 29(12): 1095-1099.
6.	Otto CM, Nishimura RA, Bonow RO, et al. 2020 ACC/AHA guideline for the management of patients with valvular heart disease: a report of the American college of cardiology/American heart association joint committee on clinical practice guidelines. Circulation, 2021, 143(5): e72-e227.
7.	Vahanian A, Beyersdorf F, Praz F, et al. 2021 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J, 2022, 43(7): 561-632.
8.	Head SJ, van Leeuwen WJ, Van Mieghem NM, et al. Surgical or transcatheter mitral valve intervention: complex disease requires complex decisions. EuroIntervention, 2014, 9(10): 1133-1135.
9.	Zoghbi WA, Enriquez-Sarano M, Foster E, et al. Recommendations for evaluation of the severity of native valvular regurgitation with two-dimensional and Doppler echocardiography. J Am Soc Echocardiogr, 2003, 16(7): 777-802.
10.	Shea BJ, Reeves BC, Wells G, et al. AMSTAR 2: a critical appraisal tool for systematic reviews that include randomised or non-randomised studies of healthcare interventions, or both. BMJ, 2017, 358: j4008.
11.	Husereau D, Drummond M, Petrou S, et al. Consolidated Health Economic Evaluation Reporting Standards (CHEERS)-explanation and elaboration: a report of the ISPOR Health Economic Evaluation Publication Guidelines Good Reporting Practices Task Force. Value Health, 2013, 16(2): 231-250.
12.	Feldman T, Foster E, Glower DD, et al. Percutaneous repair or surgery for mitral regurgitation. N Engl J Med, 2011, 364(15): 1395-1406.
13.	Obadia JF, Messika-Zeitoun D, Leurent G, et al. Percutaneous repair or medical treatment for secondary mitral regurgitation. N Engl J Med, 2018, 379(24): 2297-2306.
14.	Stone GW, Lindenfeld J, Abraham WT, et al. Transcatheter mitral-valve repair in patients with heart failure. N Engl J Med, 2018, 379(24): 2307-2318.
15.	Nachtnebel A, Reinsperger I. Percutaneous repair of mitral regurgitation with the MitraClip. Ludwig Boltzmann Institute Health Technology Assessment (LBIHTA), 2012.
16.	Santé HAd. Assessment of an edge-to-edge mitral valve repair clip and its implantation. Haute Autorité de Santé (HAS), 2015.
17.	Ansari MT, Ahmadzai N, Coyle K, et al. Mitral valve clip for treatment of mitral regurgitation: an evidence-based analysis. Ont Health Technol Assess Ser, 2015, 15(12): 1-104.
18.	Wild C. Transcatheter implantable devices for mitral valve repair in adults with chronic mitral valve regurgitation (MitraClip®, Carillon®, NeoChord DS1000). German short version of the correspondent EUnetHTA assessment, 2015.
19.	Mealing S, Feldman T, Eaton J, et al. EVEREST Ⅱ high risk study based UK cost-effectiveness analysis of MitraClip® in patients with severe mitral regurgitation ineligible for conventional repair/replacement surgery. J Med Econ, 2013, 16(11): 1317-1326.
20.	Feldman T, Kar S, Elmariah S, et al. Randomized comparison of percutaneous repair and surgery for mitral regurgitation: 5-year results of EVEREST Ⅱ. J Am Coll Cardiol, 2015, 66(25): 2844-2854.
21.	Mack MJ, Lindenfeld J, Abraham WT, et al. 3-year outcomes of transcatheter mitral valve repair in patients with heart failure. J Am Coll Cardiol, 2021, 77(8): 1029-1040.
22.	Wan B, Rahnavardi M, Tian DH, et al. A meta-analysis of MitraClip system versus surgery for treatment of severe mitral regurgitation. Ann Cardiothorac Surg, 2013, 2(6): 683-692.
23.	潘复泽, 韦恒, 周王威, 等. MitraClip与外科手术治疗二尖瓣反流的安全性与有效性比较的Meta分析. 重庆医科大学学报, 2016, 41(12): 1239-1244.
24.	Takagi H, Ando T, Umemoto T, et al. A review of comparative studies of MitraClip versus surgical repair for mitral regurgitation. Int J Cardiol, 2017, 228: 289-294.
25.	Khader AA, Allaf M, Lu OW, et al. Does the clinical effectiveness of Mitraclip compare with surgical repair for mitral regurgitation. J Card Surg, 2021, 36(3): 1103-1119.
26.	Wang TKM, Chatfield A, Wang MTM, et al. Comparison of percutaneous MitraClip versus mitral valve surgery for severe mitral regurgitation: a meta-analysis: Mitraclip and mitral valve surgery meta-analysis. AsiaIntervention, 2020, 6(2): 77-84.
27.	Oh NA, Kampaktsis PN, Gallo M, et al. An updated meta-analysis of MitraClip versus surgery for mitral regurgitation. Ann Cardiothorac Surg, 2021, 10(1): 1-14.
28.	Benito-González T, Estévez-Loureiro R, Iglesias-Gárriz I, et al. Survival advantage of MitraClip® over medical treatment in patients with mitral regurgitation: a meta-analysis. J Heart Valve Dis, 2017, 26(6): 651-658.
29.	Cubero-Gallego H, Hernandez-Vaquero D, Avanzas P, et al. Outcomes with percutaneous mitral repair vs. optimal medical treatment for functional mitral regurgitation:systematic review. Ann Transl Med, 2020, 8(15): 962.
30.	Giannini C, D'ascenzo F, Fiorelli F, et al. A meta-analysis of MitraClip combined with medical therapy vs. medical therapy alone for treatment of mitral regurgitation in heart failure patients. ESC Heart Fail, 2018, 5(6): 1150-1158.
31.	Bertaina M, Galluzzo A, D'Ascenzo F, et al. Prognostic impact of MitraClip in patients with left ventricular dysfunction and functional mitral valve regurgitation: a comprehensive meta-analysis of RCTs and adjusted observational studies. Int J Cardiol, 2019, 290: 70-76.
32.	Marmagkiolis K, Hakeem A, Ebersole DG, et al. Clinical outcomes of percutaneous mitral valve repair with MitraClip for the management of functional mitral regurgitation. Catheter Cardiovasc Interv, 2019, 94(6): 820-826.
33.	黄庆. 药物对比MitraClip治疗心力衰竭合并功能性二尖瓣反流患者疗效的Meta分析. 南昌: 南昌大学, 2019.
34.	Benito-González T, Estévez-Loureiro R, Villablanca PA, et al. Percutaneous mitral valve repair vs. stand-alone medical therapy in patients with functional mitral regurgitation and heart failure. Cardiovasc Revasc Med, 2020, 21(1): 52-60.
35.	Goel S, Pasam RT, Wats K, et al. Mitraclip plus medical therapy versus medical therapy alone for functional mitral regurgitation: a meta-analysis. Cardiol Ther, 2020, 9(1): 5-17.
36.	Kumar A, Al-Khafaji J, Shariff M, et al. Percutaneous mitral valve repair for secondary mitral valve regurgitation: a systematic review and meta-analysis. Eur J Intern Med, 2020, 78: 107-112.
37.	Vallakati A, Hasan AK, Boudoulas KD. Transcatheter mitral valve repair in patients with heart failure: a meta-analysis. Cardiology, 2021, 146(1): 42-48.
38.	Cameron HL, Bernard LM, Garmo VS, et al. A Canadian cost-effectiveness analysis of transcatheter mitral valve repair with the MitraClip system in high surgical risk patients with significant mitral regurgitation. J Med Econ, 2014, 17(8): 599-615.
39.	Armeni P, Boscolo PR, Tarricone R, et al. Real-world cost effectiveness of MitraClip combined with medical therapy versus medical therapy alone in patients with moderate or severe mitral regurgitation. Int J Cardiol, 2016, 209: 153-160.
40.	Asgar AW, Khairy P, Guertin MC, et al. Clinical outcomes and economic impact of transcatheter mitral leaflet repair in heart failure patients. J Med Econ, 2017, 20(1): 82-90.
41.	Guerin P, Bourguignon S, Jamet N, et al. MitraClip therapy in mitral regurgitation: a Markov model for the cost-effectiveness of a new therapeutic option. J Med Econ, 2016, 19(7): 696-701.
42.	Sakamaki H, Nakao K, Matsumoto T, et al. Cost-effectiveness analysis of percutaneous mitral valve repair with the MitraClip delivery system for patients with mitral regurgitation in Japan. J Med Econ, 2019, 22(12): 1312-1320.
43.	Baron SJ, Wang K, Arnold SV, et al. Cost-effectiveness of transcatheter mitral valve repair versus medical therapy in patients with heart failure and secondary mitral regurgitation: results from the COAPT trial. Circulation, 2019, 140(23): 1881-1891.
44.	Shore J, Russell J, Frankenstein L, et al. An analysis of the cost-effectiveness of transcatheter mitral valve repair for people with secondary mitral valve regurgitation in the UK. J Med Econ, 2020, 23(12): 1425-1434.
45.	Cohen DJ, Wang K, Magnuson E, et al. Cost-effectiveness of transcatheter edge-to-edge repair in secondary mitral regurgitation. Heart, 2022, 108(9): 717-724.
46.	Estler B, Rudolph V, Seleznova Y, et al. Cost-effectiveness of the MitraClip device in German heart failure patients with secondary mitral regurgitation. Eur J Health Econ, 2022. DOI:10.1007/s10198-022-01476-4.
47.	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.

1. Zhou M, Wang H, Zeng X, et al. Mortality, morbidity, and risk factors in China and its provinces, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet, 2019, 394(10204): 1145-1158.
2. Hu P, Liu XB, Liang J, et al. A hospital-based survey of patients with severe valvular heart disease in China. Int J Cardiol, 2017, 231: 244-247.
3. 叶蕴青, 许海燕, 李喆, 等. 中国不同区域老年瓣膜性心脏病构成和病因分析. 中华老年心脑血管病杂志, 2019, 21(7): 676-682.
4. 潘文志, 周达新, 葛均波. 中国二尖瓣反流患者人群数量的估测. 中国胸心血管外科临床杂志, 2021, 28(5): 495-498.
5. 潘翠珍, 潘文志, 李伟, 等. 二尖瓣解剖结构及反流的超声心动图新评价. 中华超声影像学杂志, 2020, 29(12): 1095-1099.
6. Otto CM, Nishimura RA, Bonow RO, et al. 2020 ACC/AHA guideline for the management of patients with valvular heart disease: a report of the American college of cardiology/American heart association joint committee on clinical practice guidelines. Circulation, 2021, 143(5): e72-e227.
7. Vahanian A, Beyersdorf F, Praz F, et al. 2021 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J, 2022, 43(7): 561-632.
8. Head SJ, van Leeuwen WJ, Van Mieghem NM, et al. Surgical or transcatheter mitral valve intervention: complex disease requires complex decisions. EuroIntervention, 2014, 9(10): 1133-1135.
9. Zoghbi WA, Enriquez-Sarano M, Foster E, et al. Recommendations for evaluation of the severity of native valvular regurgitation with two-dimensional and Doppler echocardiography. J Am Soc Echocardiogr, 2003, 16(7): 777-802.
10. Shea BJ, Reeves BC, Wells G, et al. AMSTAR 2: a critical appraisal tool for systematic reviews that include randomised or non-randomised studies of healthcare interventions, or both. BMJ, 2017, 358: j4008.
11. Husereau D, Drummond M, Petrou S, et al. Consolidated Health Economic Evaluation Reporting Standards (CHEERS)-explanation and elaboration: a report of the ISPOR Health Economic Evaluation Publication Guidelines Good Reporting Practices Task Force. Value Health, 2013, 16(2): 231-250.
12. Feldman T, Foster E, Glower DD, et al. Percutaneous repair or surgery for mitral regurgitation. N Engl J Med, 2011, 364(15): 1395-1406.
13. Obadia JF, Messika-Zeitoun D, Leurent G, et al. Percutaneous repair or medical treatment for secondary mitral regurgitation. N Engl J Med, 2018, 379(24): 2297-2306.
14. Stone GW, Lindenfeld J, Abraham WT, et al. Transcatheter mitral-valve repair in patients with heart failure. N Engl J Med, 2018, 379(24): 2307-2318.
15. Nachtnebel A, Reinsperger I. Percutaneous repair of mitral regurgitation with the MitraClip. Ludwig Boltzmann Institute Health Technology Assessment (LBIHTA), 2012.
16. Santé HAd. Assessment of an edge-to-edge mitral valve repair clip and its implantation. Haute Autorité de Santé (HAS), 2015.
17. Ansari MT, Ahmadzai N, Coyle K, et al. Mitral valve clip for treatment of mitral regurgitation: an evidence-based analysis. Ont Health Technol Assess Ser, 2015, 15(12): 1-104.
18. Wild C. Transcatheter implantable devices for mitral valve repair in adults with chronic mitral valve regurgitation (MitraClip®, Carillon®, NeoChord DS1000). German short version of the correspondent EUnetHTA assessment, 2015.
19. Mealing S, Feldman T, Eaton J, et al. EVEREST Ⅱ high risk study based UK cost-effectiveness analysis of MitraClip® in patients with severe mitral regurgitation ineligible for conventional repair/replacement surgery. J Med Econ, 2013, 16(11): 1317-1326.
20. Feldman T, Kar S, Elmariah S, et al. Randomized comparison of percutaneous repair and surgery for mitral regurgitation: 5-year results of EVEREST Ⅱ. J Am Coll Cardiol, 2015, 66(25): 2844-2854.
21. Mack MJ, Lindenfeld J, Abraham WT, et al. 3-year outcomes of transcatheter mitral valve repair in patients with heart failure. J Am Coll Cardiol, 2021, 77(8): 1029-1040.
22. Wan B, Rahnavardi M, Tian DH, et al. A meta-analysis of MitraClip system versus surgery for treatment of severe mitral regurgitation. Ann Cardiothorac Surg, 2013, 2(6): 683-692.
23. 潘复泽, 韦恒, 周王威, 等. MitraClip与外科手术治疗二尖瓣反流的安全性与有效性比较的Meta分析. 重庆医科大学学报, 2016, 41(12): 1239-1244.
24. Takagi H, Ando T, Umemoto T, et al. A review of comparative studies of MitraClip versus surgical repair for mitral regurgitation. Int J Cardiol, 2017, 228: 289-294.
25. Khader AA, Allaf M, Lu OW, et al. Does the clinical effectiveness of Mitraclip compare with surgical repair for mitral regurgitation. J Card Surg, 2021, 36(3): 1103-1119.
26. Wang TKM, Chatfield A, Wang MTM, et al. Comparison of percutaneous MitraClip versus mitral valve surgery for severe mitral regurgitation: a meta-analysis: Mitraclip and mitral valve surgery meta-analysis. AsiaIntervention, 2020, 6(2): 77-84.
27. Oh NA, Kampaktsis PN, Gallo M, et al. An updated meta-analysis of MitraClip versus surgery for mitral regurgitation. Ann Cardiothorac Surg, 2021, 10(1): 1-14.
28. Benito-González T, Estévez-Loureiro R, Iglesias-Gárriz I, et al. Survival advantage of MitraClip® over medical treatment in patients with mitral regurgitation: a meta-analysis. J Heart Valve Dis, 2017, 26(6): 651-658.
29. Cubero-Gallego H, Hernandez-Vaquero D, Avanzas P, et al. Outcomes with percutaneous mitral repair vs. optimal medical treatment for functional mitral regurgitation:systematic review. Ann Transl Med, 2020, 8(15): 962.
30. Giannini C, D'ascenzo F, Fiorelli F, et al. A meta-analysis of MitraClip combined with medical therapy vs. medical therapy alone for treatment of mitral regurgitation in heart failure patients. ESC Heart Fail, 2018, 5(6): 1150-1158.
31. Bertaina M, Galluzzo A, D'Ascenzo F, et al. Prognostic impact of MitraClip in patients with left ventricular dysfunction and functional mitral valve regurgitation: a comprehensive meta-analysis of RCTs and adjusted observational studies. Int J Cardiol, 2019, 290: 70-76.
32. Marmagkiolis K, Hakeem A, Ebersole DG, et al. Clinical outcomes of percutaneous mitral valve repair with MitraClip for the management of functional mitral regurgitation. Catheter Cardiovasc Interv, 2019, 94(6): 820-826.
33. 黄庆. 药物对比MitraClip治疗心力衰竭合并功能性二尖瓣反流患者疗效的Meta分析. 南昌: 南昌大学, 2019.
34. Benito-González T, Estévez-Loureiro R, Villablanca PA, et al. Percutaneous mitral valve repair vs. stand-alone medical therapy in patients with functional mitral regurgitation and heart failure. Cardiovasc Revasc Med, 2020, 21(1): 52-60.
35. Goel S, Pasam RT, Wats K, et al. Mitraclip plus medical therapy versus medical therapy alone for functional mitral regurgitation: a meta-analysis. Cardiol Ther, 2020, 9(1): 5-17.
36. Kumar A, Al-Khafaji J, Shariff M, et al. Percutaneous mitral valve repair for secondary mitral valve regurgitation: a systematic review and meta-analysis. Eur J Intern Med, 2020, 78: 107-112.
37. Vallakati A, Hasan AK, Boudoulas KD. Transcatheter mitral valve repair in patients with heart failure: a meta-analysis. Cardiology, 2021, 146(1): 42-48.
38. Cameron HL, Bernard LM, Garmo VS, et al. A Canadian cost-effectiveness analysis of transcatheter mitral valve repair with the MitraClip system in high surgical risk patients with significant mitral regurgitation. J Med Econ, 2014, 17(8): 599-615.
39. Armeni P, Boscolo PR, Tarricone R, et al. Real-world cost effectiveness of MitraClip combined with medical therapy versus medical therapy alone in patients with moderate or severe mitral regurgitation. Int J Cardiol, 2016, 209: 153-160.
40. Asgar AW, Khairy P, Guertin MC, et al. Clinical outcomes and economic impact of transcatheter mitral leaflet repair in heart failure patients. J Med Econ, 2017, 20(1): 82-90.
41. Guerin P, Bourguignon S, Jamet N, et al. MitraClip therapy in mitral regurgitation: a Markov model for the cost-effectiveness of a new therapeutic option. J Med Econ, 2016, 19(7): 696-701.
42. Sakamaki H, Nakao K, Matsumoto T, et al. Cost-effectiveness analysis of percutaneous mitral valve repair with the MitraClip delivery system for patients with mitral regurgitation in Japan. J Med Econ, 2019, 22(12): 1312-1320.
43. Baron SJ, Wang K, Arnold SV, et al. Cost-effectiveness of transcatheter mitral valve repair versus medical therapy in patients with heart failure and secondary mitral regurgitation: results from the COAPT trial. Circulation, 2019, 140(23): 1881-1891.
44. Shore J, Russell J, Frankenstein L, et al. An analysis of the cost-effectiveness of transcatheter mitral valve repair for people with secondary mitral valve regurgitation in the UK. J Med Econ, 2020, 23(12): 1425-1434.
45. Cohen DJ, Wang K, Magnuson E, et al. Cost-effectiveness of transcatheter edge-to-edge repair in secondary mitral regurgitation. Heart, 2022, 108(9): 717-724.
46. Estler B, Rudolph V, Seleznova Y, et al. Cost-effectiveness of the MitraClip device in German heart failure patients with secondary mitral regurgitation. Eur J Health Econ, 2022. DOI:10.1007/s10198-022-01476-4.
47. 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.

Chinese Journal of Evidence-Based Medicine

MitraClip device for patients with severe mitral valve regurgitation: a rapid health technology assessment

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