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To compare the efficacy and clinical outcomes of transcatheter edge-to-edge mitral valve repair (TMVr) and surgical mitral valve repair (SMVr) among patients with secondary mitral regurgitation (SMR).
Methods
Consecutive patients with SMR treated using either TMVr (n = 199) or SMVr (n = 222) at 2 centers were included and retrospectively analyzed. To account for differences in patient demographic characteristics, 1:1 propensity score matching was performed. The primary endpoint was all-cause death within 2 years after the procedure.
Results
The study population consisted of 202 matched patients. At 2 years, all-cause mortality was 24.3% for TMVr and 23.0% for SMVr (hazard ratio, 0.97; 95% confidence interval, 0.55-1.71; P = .909). Severe heart failure symptoms at 2 years were less prevalent after SMVr (New York Heart Association functional class III or IV: 13.5% vs 29.5%; P = .032) than after TMVr. A higher proportion of the SMVr patients had SMR reduction to none or mild at discharge (90.8% vs 72.0%; P < .001) and 2 years (86.5% vs 59.6%; P < .001). Among patients who achieved none or mild MR at discharge, 7 patients (10.1%) in the SMVr group and 15 (34.9%) in the TMVr group had progression to moderate or greater MR at 2 years (P = .003). Left ventricular ejection fraction (LVEF) significantly improved (+10.1% ± 11.1%; P < .001) after SMVr (LVEF at 2 years: 45.7% ± 12.8%), whereas it remained unchanged (–1.3% ± 8.9%; P = .260) after TMVr (LVEF at 2 years: 34.0% ± 13.2%).
Conclusions
In this propensity score-matched analysis, there was no significant difference in 2-year survival between TMVr and SMVr, despite greater and more durable SMR reduction, as well as LVEF improvement in the surgical group.
In a propensity score-matched retrospective cohort of patients with SMR, survival at 2 years did not differ between transcatheter edge-to-edge repair and surgical mitral valve repair, despite greater and more durable SMR reduction, as well as LVEF improvement in the surgical group. Randomized controlled trials are needed to determine the best intervention for SMR.
See Commentaries on pages 2047, 2048, and 2050.
Secondary mitral regurgitation (SMR) ensues due to left ventricular (LV) dilatation and/or papillary muscle dysfunction in the absence of structural abnormalities of the mitral valve (MV) itself. Guideline-directed medical therapy (GDMT), cardiac resynchronization, and coronary revascularization are first-line therapies of patients with heart failure (HF) associated with SMR aiming to improve the underlying LV dysfunction.
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.
Because it is a disease of the LV rather than the MV, the influence of therapeutic interventions to correct SMR on subsequent clinical outcomes remains debated.
There is no conclusive evidence supporting surgical interventions for the treatment of SMR. Although mitral annuloplasty, the most commonly used technique for surgical mitral valve repair (SMVr), was shown to reduce SMR and improve symptoms in observational studies,
Furthermore, surgical interventions consist of various techniques. Although a randomized controlled trial suggested that SMVr was associated with comparable survival but a higher risk of recurrent MR and cardiovascular readmission than chordal-sparing mitral valve replacement,
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.
Recently, 2 randomized controlled trials, Multicenter Study of Percutaneous Mitral Valve Repair MitraClip Device in Patients With Severe Secondary Mitral Regurgitation (MITRA-FR) and Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation (COAPT), investigated the efficacy of transcatheter mitral valve repair (TMVr) with the MitraClip system (Abbott, Abbott Park, Ill) in addition to GDMT compared with GDMT alone.
Although MITRA-FR provided neutral results without benefit of MitraClip for the combined endpoint of mortality and HF rehospitalization at 1 and 2 years, COAPT showed that TMVr was beneficial with respect to cumulative HF rehospitalizations, as well as survival after 24 and 36 months of follow-up.
COAPT was the first randomized controlled trial suggesting a survival benefit derived from interventional correction of SMR.
There are limited data specifically comparing TMVr with surgery for the treatment of SMR. Published studies to date did not use propensity score matching and included heterogeneous surgical techniques.
MitraClip therapy and surgical edge-to-edge repair in patients with severe left ventricular dysfunction and secondary mitral regurgitation: mid-term results of a single-centre experiencedagger.
We hypothesized that TMVr and SMVr for the treatment of SMR may result in different survival, functional, and echocardiographic outcomes. Thus, the present study aimed to compare midterm clinical outcomes throughout 2 years between patients undergoing TMVr using the MitraClip system and patients undergoing SMVr using ring annuloplasty for the treatment of SMR in 2 propensity score–matched cohorts.
Methods
Study Population
Consecutive patients with moderate or severe SMR treated with TMVr using the MitraClip system (between 2012 and 2018) and with SMVr using 2 models of restrictive annuloplasty rings (between 2005 and 2018) at 2 Swiss institutions (Inselspital, Bern University Hospital and Herzklinik Hirslanden, Zurich) were included into this study and retrospectively analyzed. The study complied with the Declaration of Helsinki and was approved by the local ethics committee. All patients provided written informed consent for participation.
MV Procedures
Procedures were performed in accordance to best practice at the corresponding time of intervention.
Guidelines on the management of valvular heart disease: the task force on the management of valvular heart disease of the European Society of Cardiology.
TMVr was performed using the MitraClip transcatheter mitral valve repair system (MitraClip NTR and XTR). Relevant concomitant coronary artery disease was treated by means of percutaneous coronary intervention (PCI) as indicated. SMVr was performed via sternotomy using a restrictive mitral ring annuloplasty in all cases (either Carpentier-Edwards Physio I/II or the Carpentier-McCarthy-Adams IMR ETlogix; Edwards Lifesciences, Irvine, Calif). Concomitant coronary artery bypass grafting was performed in the presence of relevant coronary artery disease. The specific surgical techniques such as ring type, implantation technique, and myocardial-preservation method were at the surgeon's discretion. All patients received GDMT.
Data Collection and Definitions
Demographic characteristics and echocardiographic parameters of the TMVr group were collected retrospectively for patients treated before November 2017 and prospectively for all other patients in a dedicated registry, while the data of the SMVr group were collected retrospectively. Follow-up data at 2 years were obtained by direct telephone contact with the patients or their relatives, documentation from referring physicians, and hospital medical records. If none of them was available, survival data were obtained from an administrative database.
The primary endpoint was all-cause death within 2 years of follow-up after the procedure. Secondary endpoints included all-cause death at 30 days, the echocardiographic degree of MR at discharge and at 2 years, functional status as assessed by New York Heart Association (NYHA) class, and the change in LV ejection fraction (LVEF) at 2 years. MR was graded as mild, moderate, or severe according to the recommendations of the European Association of Cardiovascular Imaging.
Recommendations for the echocardiographic assessment of native valvular regurgitation: an executive summary from the European Association of Cardiovascular Imaging.
Categorical data are represented as frequencies and percentages, and the differences between groups were evaluated with the χ2 test or Fisher exact test. Continuous variables were tested for normal distribution using the Shapiro-Wilk test. Normally distributed variables are expressed as mean values ± standard deviation and compared between groups using Student t test. Nonnormally distributed variables are expressed as median values with interquartile ranges and the difference between a set of matched pairs were tested using Wilcoxon signed-rank test. Propensity score was modeled using a multivariable logistic regression model based on the following baseline variables: age, sex, body surface area, European System for Cardiac Operative Risk Evaluation (EuroSCORE) II score, hypertension, chronic kidney disease, atrial fibrillation, history of myocardial infarction, previous coronary artery bypass grafting, NYHA functional class III or IV and LVEF. These variables were selected based on their presumed association with treatment strategy selection and mortality. Propensity score matching was performed using the 1-to-1 greedy nearest neighbor matching protocol without replacement within a caliper of 0.2.
Standardized mean differences (SMDs) were calculated for all the baseline variables in the unmatched and matched cohorts to assess the balance in baseline demographic characteristics. All outcome analyses were performed in the propensity score–matched cohorts. Event-free survival curves were constructed using the Kaplan-Meier method and Cox proportional hazards models were used to calculate hazard ratios (HRs) and 95% confidence interval (95% CI). Multivariable adjustment was further performed with baseline hypertension, diabetes, previous PCI, and baseline MR in view of the presumed association with mortality and residual imbalances between groups. Statistical analyses were performed using EZR software (Saitama Medical Center, Jichi Medical University, Saitama, Japan), which is a graphical user interface for R (R Foundation for Statistical Computing, Vienna, Austria).
Results
Patients
The unmatched population consisted of 199 patients with SMR treated with TMVr between 2012 and 2018 and 222 patients treated with SMVr between 2005 and 2018. Baseline characteristics of the unmatched cohort differed significantly as summarized in Table 1. Patients treated with SMVr were more frequently men (69.8% vs 61.3%; SMD = 0.180) with larger body surface area (1.89 ± 0.20 m2 vs 1.83 ± 0.20 m2; SMD = 0.277), younger (aged 65.8 ± 9.5 years vs 73.9 ± 10.2 years; SMD = 0.821), and had lower surgical-risk (EuroSCORE II score: 8.14 ± 8.95 vs 11.13 ± 7.42; SMD = 0.364) compared with patients treated with TMVr. Propensity score matching resulted in 101 pairs (Figure E1). Histograms of propensity score before and after matching are provided in Figure E2. There were some residual imbalances in gender (SMD = 0.126), hypertension (SMD = 0.151), diabetes (SMD = 0.231), severe pulmonary hypertension (SMD = 0.124), and previous myocardial infarction (SMD = 0.122). In particular, the rate of previous PCI (59.4% vs 29.7%; SMD = 0.626) and severe MR (79.2% vs 43.6%; SMD = 0.787) remained significantly higher in the TMVr group due to the fundamental difference in the treatment strategy. Data on the SMVr procedures are provided in Table E1.
Table 1Baseline characteristics of the unmatched and matched population
Characteristic
Unmatched cohort
Matched cohort
TMVr
SMVr
SMD
TMVr
SMVr
SMD
N = 199
N = 222
N = 101
N = 101
Age (y)
76 (69-81)
67 (59-73)
0.821
70 (61-77)
70 (65-74)
0.001
Female sex
77 (38.7)
67 (30.2)
0.180
37 (36.6)
31 (30.7)
0.126
Body surface area (mm2)
1.83 ± 0.20
1.89 ± 0.20
0.277
1.87 ± 0.22
1.88 ± 0.20
0.041
EuroSCORE II (%)
9.29 (5.60-15.14)
4.68 (2.50-9.15)
0.364
8.07 (4.33-11.62)
5.19 (3.48-10.03)
0.046
Hypertension
121 (60.8)
159 (72.6)
0.252
67 (66.3)
74 (73.3)
0.151
Diabetes
46 (23.1)
63 (28.6)
0.126
25 (24.8)
33 (32.7)
0.231
CKD (Ccr <60)
132 (66.7)
93 (42.1)
0.509
55 (54.5)
52 (51.5)
0.060
Atrial fibrillation
83 (41.7)
50 (22.5)
0.420
34 (33.7)
30 (29.7)
0.085
Severe PH (systolic PAP >55 mm Hg)
38 (27.5)
27 (15.3)
0.300
18 (17.8)
16 (15.8)
0.124
Coronary artery disease
Previous MI
65 (32.7)
115 (51.8)
0.395
41 (42.6)
37 (36.6)
0.122
Previous CABG
26 (13.1)
34 (15.3)
0.065
15 (14.9)
16 (15.8)
0.027
Previous PCI
111 (56.1)
69 (31.1)
0.521
60 (59.4)
30 (29.7)
0.626
NYHA class III or IV
147 (73.9)
126 (59.4)
0.310
64 (63.4)
68 (67.3)
0.083
LVEF (%)
30 (25-40)
35 (30-45)
0.381
33 (25-45)
35 (25-40)
0.014
MR severe or greater
166 (83.4)
102 (45.9)
0.852
88 (79.2)
44 (43.6)
0.787
Values for categorical variables are presented as n (%). Values for continuous variables are presented as mean ± standard deviation or median values with interquartile ranges. TMVr, Transcatheter mitral valve repair; SMVr, surgical mitral valve repair; SMD, standardized mean difference; EuroSCORE, European System for Cardiac Operative Risk Evaluation CKD, chronic kidney disease; Ccr, creatinine clearance; PH, pulmonary hypertension; PAP, pulmonary artery pressure; MI, myocardial infarction; CABG, coronary artery bypass grafting; PCI, percutaneous coronary intervention; NYHA, New York Heart Association; LVEF, left ventricular ejection fraction; MR, mitral regurgitation.
Survival status at 2 years was available in 200 out of 202 patients (99.0%). At 30 days, 4 patients (4.0% ± 2.0%) in the SMVr group and 7 patients (7.0% ± 2.6%) in the TMVr group had died (HR, 0.58; 95% CI, 0.17-1.97; P = .378) (Table 2). At 2 years, all-cause death was observed in 23 patients (23.0% ± 4.2%) in the SMVr group and in 24 patients (24.3% ± 4.3%) in the TMVr group (HR, 0.97; 95% CI, 0.55-1.71; P = .909; HRadjusted, 0.92; 95% CI, 0.48-1.76; P = .796) (Table 2 and Figure 1).
Table 2Clinical, echocardiographic, and functional outcomes
Figure 1Two-year survival of surgical versus transcatheter mitral valve repair for secondary mitral regurgitation. Kaplan-Meier cumulative event curves depict freedom from all-cause death after surgical mitral valve repair (SMVr) or transcatheter mitral valve repair (TMVr) in all patients with available follow-up (99%). Dashed lines depict 95% confidence intervals (CI). There was no significant difference in survival between patients undergoing SMVr and TMVr (hazard ratio, 0.97; 95% CI, 0.55-1.71; P = .909; hazard ratioadjusted [HRadjusted] 0.92; 95% CI, 0.48-1.76; P = .796).
At 2 years, HF symptoms as assessed by NYHA functional class were available in 136 patients (89.5%) (75 in the SMVr group and 61 in the TMVr group) among the 152 patients alive. NYHA functional class III or IV was reported in 10 patients (13.3%) of the SMVr group and 18 patients (29.5%) of the TMVr group (P = .032) (Table 2 and Figure E3).
Echocardiographic Outcomes
At hospital discharge, assessment of the severity of residual MR was available in 98 patients after SMVr and 100 patients after TMVr. Among those, 93 (94.9%) and 92 (92.0%) patients had reduction in MR of at least 1 grade, respectively (P = .568). Eighty-nine patients (90.8%) in the SMVr and 72 (72.0%) in the TMVr group had mild or less residual MR (P < .001) (Table 2 and Figure 2). Severe residual MR was only observed in 2 patients (2%) and 3 patients (3%) in the SMVr and TMVr group, respectively (P = 1.000). At 2 years, echocardiographic follow-up was complete in 131 patients (85.5%) (74 in the SMVr group and 57 in the TMVr group) among the 152 patients alive. The proportion of patients with no or mild residual MR was higher in the SMVr than in the TMVr group (86.5% vs 59.6%; P < .001) (Table 2 and Figure 2). Among patients in whom no or mild MR was achieved at discharge, 7 patients (10.1%) in the SMVr group and 15 patients (34.9%) in the TMVr group had MR progression to moderate or greater at 2 years (P = .003) (Figure E4).
Figure 2Severity of mitral regurgitation (MR) after transcatheter (TMVr) or surgical mitral valve repair (SMVr). MR severity was available for 100 and 98 patients at hospital discharge, and 57 and 74 patients at 2 years in the SMVr and TMVr group, respectively. At discharge, 72 patients (72.0%) after TMVr and 89 patients (90.8%) after SMVr had MR reduction to none or mild (P < .001). At 2 years, 34 (59.6%) and 64 (86.5%) still had MR none or mild (P < .001) in the respective groups. SMR, Secondary mitral regurgitation.
At 2 years, LVEF significantly improved (35% [25%-40%] to 48% [35%-55%]; P < .001) in the SMVr group, whereas LVEF remained unchanged (33% [25%-45%] to 35% [20%-45%]; P = .205) in the TMVr group (P < .001) (Table 2).
Subgroup Analysis
The association of the treatment strategy with all-cause mortality was consistent across all the examined subgroups (Figure 3). There were no significant interactions between the impact of the treatment strategy on mortality and age, sex, surgical risk as assessed by EuroSCORE II, baseline LVEF, the baseline severity of SMR, and revascularization (before or at the time of the procedure).
Figure 3Subgroup analyses for freedom from all-cause death at 2 years. Absolute numbers of event and total number of patients, hazard ratios and 95% confidence intervals (CI), and P values for interaction are provided. There were no significant interactions between the impact of the treatment strategy on mortality and age, sex, surgical risk as assessed by European System for Cardiac Operative Risk Evaluation II (EuroScore II), baseline left ventricular ejection fraction (LVEF), the baseline severity of secondary mitral regurgitation, and revascularization (before or at the time of procedure). SMVr, Surgical mitral valve repair; TMVr, Transcatheter mitral valve repair.
Overall, 37 patients (18.3%) had moderate or severe residual MR at discharge. Patients with moderate or severe residual MR had a numerically higher rate of all-cause mortality at 2 years (HR, 1.64; 95% CI, 0.83-3.26; P = .155) compared with patients with no or mild residual MR (Figure E5). There was no significant interaction between the treatment strategy (TMVr or SMVr) and the influence of residual MR (moderate or greater) on the incidence of all-cause death (P = .204).
Whereas LVEF remained largely unchanged (+2.9% ± 11.9%; P = .328) in patients with moderate or severe residual MR, LVEF significantly improved (+5.5% ± 11.6%; P < .001) in patients in whom no or mild MR was achieved after the procedure. The improvement in LVEF was associated with better functional status (NYHA III or IV: 6.8% vs 39.3%; P < .001) (Figure E6, A). NYHA functional class III or IV was more frequently observed in patients who had MR progression to moderate or greater during follow-up (45.5%) and those with stable moderate or greater MR (40.0%) compared with patients with stable none/mild MR (13.4%) (P = .001) (Figure E6, B).
Discussion
The salient findings of the present propensity score–matched analysis comparing TMVr and SMVr for the treatment of SMR can be summarized as follows:
•
All-cause death at 2 years did not differ between the TMVr and SMVr cohorts.
•
Both SMVr and TMVr achieved an immediate MR reduction to moderate or less in more than 90% of patients. Reduction to no or mild MR was more frequently achieved with SMVr.
•
Approximately one-third of patients in the TMVr group experienced progression of residual MR during the follow-up period compared with 10% of patients in the SMVr group. Patients with MR progression had more severe HF symptoms.
•
Improvement of LVEF was observed at 2 years after SMVr, whereas LVEF remained unchanged after TMVr. Patients with improved LVEF had improved HF symptoms.
To date, there are only limited data assessing the efficacy and safety of SMVr for the treatment of patients with HF and SMR consisting of small observational studies that suggested improvement in LV function and functional status.
SMVr and TMVr for the treatment of SMR have been compared in few observational studies, as well as in a subgroup of the Endovascular Valve Edge-to-Edge Repair Study (EVEREST) randomized trial. Kortlandt and colleagues
compared 365 SMR patients treated with TMVr with 95 patients with MV surgery, and found comparable adjusted survival up to 3 years (HR, 0.86; 95% CI, 0.54-1.38; P = .541). In the subgroup of patients with SMR in the EVEREST trial (n = 56), there was no significant difference between the TMVr and SMVr regarding the composite end point of death, MV surgery or reoperation, and 3+ or 4+ SMR at 5 years (28.6% vs 40.5%; P = .43).
However, these findings were obtained in patients treated with heterogeneous surgical techniques (repair and replacement). Two other studies specifically compared SMVr using ring annuloplasty with TMVr in unmatched SMR patients.
MitraClip therapy and surgical edge-to-edge repair in patients with severe left ventricular dysfunction and secondary mitral regurgitation: mid-term results of a single-centre experiencedagger.
In a single-center retrospective study of 76 patients treated with SMVr and 95 patients with TMVr, SMVr was associated with a better reduction of MR and comparable adjusted survival at 6 months. Similarly, in another study of 65 patients treated with SMVr and 55 with TMVr, SMVr was associated with a greater and more durable reduction of MR and comparable crude survival outcome at a median follow-up of 4 years.
The present propensity score–matched cohort study, in which TMVr was compared with SMVr using a rather uniform surgical technique limited to 2 complete ring annuloplasty models, corroborates previous findings and support the importance of durable SMR reduction to improve HF symptoms. The surgical results compare favorably with contemporary literature with low 30-day mortality and durable MR reduction in >85% of patients throughout 2 years of follow-up.
This contrasts with the high recurrence rate (59% at 2-year follow-up) reported in the randomized trial piloted by the Cardio-Thoracic Surgery Network comparing mitral valve repair and replacement for the treatment of SMR.
While it is unclear whether differences in terms of surgical techniques, medical therapy, or patient selection influenced the low recurrence rate in our cohort, this observation seems to support the use of SMVr over MV replacement as first-line option in patients with SMR. Although patients undergoing SMVr had fewer HF symptoms, this did not translate into a survival benefit at 24 months.
found no prognostic difference in patients with MR 0+/1+ compared with those with MR 2+, as opposed to the results of a recent single-center observational study.
Of note, reverse LV remodeling and optimized GDMT during hospital stay and follow-up visits may further support SMR regression as observed in some patients of our cohort. Although the prognostic importance of achieving mild/none residual MR is well established in patients with primary MR,
further studies are needed in patients with SMR. From a symptomatic point of view, our data show that successful treatment of SMR, irrespective of the technique used, is associated with improved HF symptoms. Along the same line, patients with progressive residual MR during follow-up had similarly impaired functional status compared with patients with procedural failure.
LV reverse remodeling has been documented both after isolated and concomitant MV surgery.
Coronary artery bypass surgery with or without mitral valve annuloplasty in moderate functional ischemic mitral regurgitation: final results of the randomized ischemic mitral evaluation (RIME) trial.
Conversely, an ongoing LV dilatation was observed in the COAPT trial in both groups during the study period that was significantly worse in the GDMT group.
Similarly, in our study, LVEF remained unchanged in the TMVr group but improved in the SMVr cohort. Several factors may explain these diverging responses to treatment including more complete revascularization in the surgical group, the selection of patients with more advanced disease for TMVr, and finally higher remaining volume overload due to residual or progressive MR in some of the patients treated percutaneously.
The data reported in our work add to the evidence that helps to guide heart team decisions. When defining therapeutic goals together with the patient and his/her family, differences in terms of safety and invasiveness of each procedure that were not covered by our longer-term study need to be taken into consideration. In the EVEREST trial, major adverse events in particular bleeding complications were significantly higher in the surgical group (48% vs 15%; P < .001). A dedicated randomized trial, the Multicenter, Randomized, Controlled Study to Assess Mitral Valve Reconstruction for Advanced Insufficiency of Functional or Ischemic Origin (MATTERFHORN) study (NCT02371512), comparing SMVr with TMVr for the treatment of ischemic and nonischemic SMR is ongoing and will help to further define the most appropriate treatment strategy in this complex population of patients.
Study Limitations
The present analysis is a retrospective observational study with inherent limitations associated with its design. Despite propensity score matching, important differences between both study groups may remain as patients allocated to TMVr may have been rejected for surgery due to reasons that may not have been captured in our analysis (eg, frailty, liver disease, hostile chest, and porcelain aorta). Second, echocardiographic data were not centrally adjudicated by a core laboratory. Third, data on GDMT were only available for the TMVr cohort at baseline (Table E2). The baseline use of GDMT in the TMVr cohort appears to be overall comparable to those of recent SMR randomized controlled trials; however, the composition of GDMT may have been adjusted during follow-up. The results of the present study mirror the experience of 2 experienced centers in the treatment of MV disease and may not be generalizable to other institutions. Lastly, temporal changes in the management of SMR and underlying LV disease during the study period may have affected the results. Therefore, our findings are hypothesis-generating and need to be confirmed in future prospective randomized studies.
Conclusions
In this propensity score–matched cohort analysis, there was no significant difference in 2-year survival between TMVr and SMVr for the treatment of SMR, despite greater and more durable SMR reduction, as well as LVEF improvement in the surgical group (Figure 4 and Video 1).
Figure 4Surgical versus transcatheter repair for secondary mitral regurgitation (MR): A propensity score (PS)-matched comparison. In a propensity matched retrospective cohort of patients with secondary MR, survival up to 2 years did not differ between transcatheter mitral valve repair (TMVr) and surgical mitral valve repair (SMVr). However, surgery resulted in better and more durable MR reduction and improvement of heart failure symptoms and left ventricular ejection fraction (LVEF). Randomized controlled trials are needed to determine the best intervention for secondary MR. HR, Hazard ratio; CI, confidence interval; NYHA, New York Heart Association.
Dr Okuno reports personal fees from Abbott; Dr Praz has received travel expenses from Edwards Lifesciences, Abbott Medical, and Polares Medical; Dr Pilgrim has received research grants to the institution from Biotronik and Boston Scientific and speaker fees from Boston Scientific and Biotronik, and performed a consultancy with HighLifeSAS; Dr Windecker reports research and educational grants to the institution from Abbott, Amgen, BMS, Bayer, Boston Scientific, Biotronik, Cardinal Health, CardioValve, CSL Behring, Daiichi-Sankyo, Edwards Lifesciences, Johnson & Johnson, Medtronic, Querbet, Polares, Sanofi, Terumo, and Sinomed; Dr Windecker serves as unpaid advisory board member and/or unpaid member of the steering/executive group of trials funded by Abbott, Abiomed, Amgen, Astra Zeneca, BMS, Boston Scientific, Biotronik, Cardiovalve, Edwards Lifesciences, MedAlliance, Medtronic, Novartis, Polares, Sinomed, V-Wave, and Xeltis, but has not received personal payments by pharmaceutical companies or device manufacturers; he is also member of the steering/executive committee group of several investigated-initiated trials that receive funding by industry without impact on his personal remuneration and is an unpaid member of the Pfizer Research Award selection committee in Switzerland; and Dr Wenaweser reports consulting/personal fees from Edwards Lifesciences, Medtronic. All other authors reported no conflicts of interest.
The Journal policy requires editors and reviewers to disclose conflicts of interest and to decline handling or reviewing manuscripts for which they may have a conflict of interest. The editors and reviewers of this article have no conflicts of interest.
The authors thank Dik Heg, PhD, head of cardiovascular health, CTU Bern, for his advice and support on the statistical analysis.
Figure E2Histograms of propensity score before and after matching. Propensity score matching was performed using the one-to-one nearest neighbor matching protocol without replacement within a caliper of 0.2. TMVr, Transcatheter mitral valve repair; SMVr, surgical mitral valve repair.
Figure E3New York Heart Association (NYHA) functional class at 2 years. NYHA functional class III or IV was present in 10 patients (13.3%) of the surgical mitral valve repair (SMVr) group and 18 patients (29.5%) of the transcatheter mitral valve repair (TMVr) group (P = .032).
Figure E4Severity of mitral regurgitation (MR) at 2 years stratified by the degree of residual MR at discharge. A, Among patients who achieved none or mild MR at discharge, 7 patients (10.1%) in the surgical mitral valve repair (SMVr) group and 15 patients (34.9%) in the transcatheter mitral valve repair (TMVr) group had progression of residual MR to moderate or more (P = .003). B, Among patients who had moderate or severe MR at discharge, 2 patients (40.0%) in the SMVr group and 6 patients (42.9%) in the TMVr group had reduction of residual MR to mild or less at 2 years (P = 1.0).
Figure E5Event-free survival curves stratified by postprocedural mitral regurgitation (MR). Kaplan-Meier curves depict freedom from all-cause death according to post-procedural MR moderate or severe versus none or mild. Dashed lines depict 95% confidence intervals (CI). Patients with moderate or severe residual MR had a numerically higher rate of all-cause mortality at 2 years (hazard ratio [HR], 1.64; 95% confidence interval [CI] 0.83-3.26; P = .155) compared with patients with no or mild residual MR.
Figure E6New York Heart Association (NYHA) functional class at 2 years according to (A) functional change in LV and (B) temporal change in mitral regurgitation. A, Patients who had any improvement in left ventricular ejection fraction (LVEF) had significantly better heart failure (HF) symptoms compared with patients who had no improvement in LVEF (NYHA functional class III or IV: 6.8% vs 39.3%; P < .001). B, NYHA functional class III or IV was more frequently observed in patients who had progression of residual MR to moderate or greater (45.5%) and those remained in moderate or greater MR (40.0%) than those with none or mild MR (13.4%) (P = .001). SMR, Secondary mitral regurgitation.
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.
MitraClip therapy and surgical edge-to-edge repair in patients with severe left ventricular dysfunction and secondary mitral regurgitation: mid-term results of a single-centre experiencedagger.
Guidelines on the management of valvular heart disease: the task force on the management of valvular heart disease of the European Society of Cardiology.
Recommendations for the echocardiographic assessment of native valvular regurgitation: an executive summary from the European Association of Cardiovascular Imaging.
Coronary artery bypass surgery with or without mitral valve annuloplasty in moderate functional ischemic mitral regurgitation: final results of the randomized ischemic mitral evaluation (RIME) trial.
Okuno and colleagues1 reported 2-year outcomes comparing surgical repair with restrictive mitral annuloplasty (RMA) versus transcatheter edge-to-edge repair (TEER) for secondary mitral regurgitation (SMR). It highlights contradictions in the 2020 American Heart Association/American College of Cardiology (AHA/ACC) guidelines for the indication for TEER in SMR was Class IIb with level of evidence B-R.2 In that study of 202 patients, the investigators compared propensity-matched surgical versus transcatheter repair for SMR with a report published immediately after the presentation of new AHA/ACC guidelines.
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The optimal treatment of secondary mitral regurgitation (MR) remains controversial in the era of transcatheter mitral valve repair (TMVr). Patients with severe secondary MR are undoubtedly a challenging population. Perhaps 20% or more of patients with chronic heart failure have MR, which increases their risk of death by at least 2-fold.1 Surgery, specifically chordal-sparing mitral valve replacement, has been shown to reduce significant postoperative MR, heart failure–related adverse events, and admissions for this population, but has not been demonstrated to improve survival.
In their recently published article, Okuno and colleagues1 explore surgical repair versus transcatheter edge-to-edge repair (TEER) for secondary mitral regurgitation (MR). This manuscript is timely after the 2020 American Heart Association/American College of Cardiology (AHA/ACC) guidelines in which TEER was given a Class IIa indication in the management of severe secondary MR.2 This elegant, retrospective, propensity-matched study comparing 202 patients is the first surgical versus transcatheter repair comparison for secondary MR after the new AHA/ACC guidelines.
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