UNIVERSITÀ DI PISA
SCUOLA DI SPECIALIZZAZIONE IN MALATTIE DELL’APPARATO CARDIOVASCOLARE
Direttore: Prof. Raffaele De Caterina
Tesi di specializzazione
Transcatheter mitRal valve rEpair early after acute Myocardial infArction and
low outPut state: a troublesome liaison.
A preliminary analysis from the REMAP registry.
CANDIDATO: Dr. Amedeo Matteucci
PRIMO RELATORE ACCADEMICO: Prof. Roberto Pedrinelli
RELATORE: Dr. Fabrizio Oliva
CORRELATORE: Dr.ssa Nuccia Morici
Abstract
Background: Acute secondary mitral regurgitation (SMR) complicated by low cardiac output state
(LCOS) after an acute myocardial infarction (AMI) is associated with increased morbidity and mortality. Transcatheter mitral valve repair (TMVR) with MitraClip system is a less invasive alternative to surgery which appears to be promising in high operative risk patients. However, its role in these specific setting remains poorly defined.
Purpose: To assess baseline, echocardiographic and procedural characteristics of patients admitted
for infarct related acute SMR complicated by LCOS or cardiogenic shock (CS) treated with the MitraClip implantation, in order to identify ‘responders’ and to evaluate whether it represents a bridge to heart replacement therapies or recovery.
Methods: In this preliminary analysis of the REMAP registry, we retrospectively collected data on
10 consecutive patients who underwent MitraClip implantation for moderate to severe or severe acute SMR post-infarct at 3 italian centers between January 2014 and December 2019. As an all-comers initiative, exclusion criteria were minimal. Median follow-up period was 1 year. Primary endpoint was a composite of overall mortality, heart failure hospitalization, need for urgent heart replacement therapies, persistent inotropic/mechanical support dependence or urgent conversion to open heart surgery. Its single components were the secondary endpoints along with NYHA class ≤ II and MR grade ≤ 2+ during follow-up.
Results: Discharge survival was 90%. 4 out of 5 patients had MR grade ≤ 2+ and a NHYA class ≤ II at 1-year of follow-up. Primary endpoint was 55.6 % and 87.5 % at 3-months and 1-year, respectively. 1-year overall mortality was 37.5 %; among survived patients, 3 were treated with long-term left ventricular assist device, one of whom subsequently underwent orthotopic heart transplantation.
Conclusions: This preliminary analysis from the REMAP registry, shows how MitraClip®
procedure in patients with infarct related acute SMR complicated by LCOS or CS should be used as a bridge to heart replacement therapies and not as a definitive treatment to achieve recovery.
Introduction
Acute secondary mitral regurgitation (SMR) complicating an acute myocardial infarction (AMI) is a life-threatening mechanical complication associated with increased morbidity and mortality1. Severe SMR may occur with a frequency ranging from 0.3 to 3%1,2.
Infarct-related mitral regurgitation (MR) is thought to be due to acute ischemia of the papillary muscle; this can result in incomplete mitral valve closure during systole or an actual rupture of the papillary muscles due to myocardial necrosis, ultimately causing severe mechanical disruption of the mitral valve apparatus. The postero-medial papillary muscle is more susceptible to ischemia because is usually supplied only by the postero-descending artery3 and, consequently, the most common culprit vessel is the right coronary artery, albeit the left circumflex artery (LCX) could also be involved4.
Unlike chronic MR, in acute setting left atrial compliance is often low, leading to rapid equilibration of ventricular and atrial pressures during systole; this, together with diastolic and/or systolic dysfunction, may lead to pulmonary oedema and low cardiac output state (LCOS) or cardiogenic shock (CS) during the acute or subacute phase of the AMI5.
It is widely accepted that in patients with acute SMR related to papillary muscle rupture, emergent surgical intervention remains the treatment of choice given the exceedingly high mortality rate (up to 80%) without intervention6, though it is associated with mortality of nearly 407.
Regarding the treatment of patients without papillary muscle rupture, it has been reported that primary percutaneous coronary intervention (PCI), together with medical therapy, could reduce the degree of SMR and should therefore be the first line of treatment8. When interim hemodynamic stabilization is required, mechanical left ventricular unloading with Intra-Aortic Balloon Pump (IABP)9, percutaneous left-ventricular assist devices (Impella or TandemHeart)10,11 or Extra-Corporeal Membrane Oxygenator (ECMO)12 may be considered to decrease afterload and cardiac
Although most patients may clinically improve after successful PCI and supportive treatment, others may get worse or become dependent on ventilatory or circulatory support and mitral valve intervention may be required to allow stabilization and recovery.
Mitral surgery has been historically considered the most suitable therapeutic approach for the treatment of these patients, with valve repair showed a better outcome than replacement13. Despite the reduction in mortality rates associated with surgery, there is still a substantial risk associated with this procedure with a pooled 30-day mortality of 19%14.
In this context, transcatheter mitral valve repair (TMVR) with MitraClip device (Abbott Vascular, Santa Clara, California) has recently emerged as an alternative option in patients with high operative risk. Nevertheless, while the impact of TMVR on outcomes in chronic severe symptomatic SMR has been widely documented15–17, there are scarse data regarding patients with acute ischaemic SMR18–22.
The reduction in regurgitant volume achieved by MitraClip treatment results in acute rise in forward stroke volume and CO and maintenance of adequate mean arterial pressure, along with left ventricular (LV) unloading by reducing left ventricular end-diastolic pressure and volume23.
Anyway, despite these potential hemodynamic effects, there is no robust data that this translates into an improvement in clinical outcome: it remains uncertain whether SMR is mainly a marker for worse LV function (and hence survival) or a target for therapy and, as a consequence, there is no evidence to support an unconditional use of TMVR in this setting to prevent new episodes of patient’s clinical deterioration in the short and long term.
Therefore, the purpose of our retrospective registry on patients with infarct related acute SMR complicated by LCOS or CS treated with a MitraClip implantation, is to identify ‘responders’ and to evaluate whether it represents a bridge to heart replacement therapies or recovery.
Patients and methods
The REMAP registry is a multicenter international retrospective observational study in which we are collecting all consecutive patients presenting to 8 recruiting centers from January 2014 and December 2019 treated with MitraClip® system due to infarct related acute SMR, with no evidence of ruptured chordae or papillary muscle, complicated by LCOS or CS within 3 months from AMI which remained symptomatic or dependent on circulatory support or mechanical ventilation despite optimal medical therapy; all patients were considered as being at high risk for conventional surgery and therefore MitraClip® implantation was performed to allow stabilization and recovery. As an all-comers initiative, only subjects who are unable to comply with study follow-up procedures were excluded. No formal sample size calculation will be used since the goal is to obtain participation by all possible eligible patients. All analyses will be descriptive in nature and no formal pre-specified hypothesis testing is planned.
LCOS was defined as low cardiac index (CI < 2.0 - 2.2 L/min/m2 or need for inotropic or mechanical support to achieve higher values) despite adequate cardiac filling pressure with signs of end-organ dysfunction.
All these parameters have been analysed:
• demographic data (age, sex, history of hypertension, diabetes, dyslipidemia, smoke, chronic
kidney disease, extracardiac arteriopathy, atrial fibrillation, chronic obstructive pulmonary disease, previous PCI, CABG or device therapy);
• estimated mortality risk for cardiac surgery (EUROSCORE II, STS score);
• coronary anatomy at catheterization (culprit vessel, extent of coronary artery disease,
completeness of myocardial revascularization);
• need for pharmacologic or short-term mechanical circulatory support such as IABP,
• New York Heart Association (NYHA) functional class, laboratory parameters (serum
creatinine, total bilirubin, hemoglobin and NT-proBNP), echocardiographic parameters (ejection fraction [EF], MR grade, effective regurgitant orifice area, tricuspid regurgitation grade, tricuspid annular plane excursion, pulmonary artery systolic pressure [PASP]) and guideline-directed medical therapy (GDMT);
• HF hospitalization or urgent conversion to open heart surgery;
• need for long-term heart replacement therapies (i.e LVAD or orthotopic heart
transplantation) or persistent inotropic support.
Procedural and clinical adverse events during follow-up were adapted from MVARC criteria24. Primary endpoint was a composite of overall mortality, heart failure hospitalization, need for urgent heart replacement therapies (i.e. LVAD or UNOS status 1 Heart Transplantation), persistent inotropic (as defined as need of continous intravenous inotropic support or repeated ambulatory levosimendan administrations) or mechanical support (i.e IABP, Impella® or ECMO) dependence or urgent conversion to open heart surgery. Its single components were the secondary endpoints along with NYHA class improvement and MR grade reduction during follow-up. Both endpoints were evaluated at discharge, 3-months, 6-months and 1-year of follow-up.
STATISTICAL ANALYSIS
Categorical variables are presented as frequencies and percentages; continuous variables are presented as mean standard deviation or as median and interquartile range (IQR) according to their distribution.
Statistical comparisons were not performed due to the manuscript being descriptive in nature with no formal comparison group.
Results
In this preliminary analysis of REMAP registry, a total of 201 consecutive patients have been enrolled using a comprehensive analysis of hospital records. The study population included 10 patients classified as infarct related acute SMR complicated by LCOS or CS (Figure 1).
The baseline characteristics of the study population are summarized in Table 1.
The most frequent cardiovascular risk factor was hypertension. One patient has had previous cardiac resynchronization therapy. The most common infarct-related artery (IRA) was LCX. Multivessel coronary artery disease was present in 6 patients; of them, 3 underwent complete revascularization.
Baseline echocardiographic characteristics are presented in Table 2. All patients had moderate to severe (3+) or severe (4+) SMR. 4 out of 9 patients had LV ejection fraction (EF) < 30%.
Overall, our cohort was a high-risk population as evidenced by clinical and echocardiographic features despite of a mean age of 64 years.
Procedure and discharge
Clinical and laboratory parameters before and 48 hours post clip are shown in Table 3.
Median time from AMI to TMVR was 54 days (30-95) and length of hospitalization was 43 days (31-59). Among all patients, 1 experienced worsening of MR severity during index hospitalization. The median gradient post clip was 4 mmHg (2-4). No significant change in median EF and PASP was observed (Table 2). During hospitalization, all patients were treated with intravenous diuretics; two patients did not require circulatory support before the procedure and had LCX IRA and an almost normal EF. After MitraClip® implantation 5 out of 9 patients did not necessitate any support (Table 3). Median NT-proBNP values (available for six patients) were reduced at discharge [8509 pg/ml (4508-17565) vs. 4794 pg/ml (2630-6267).
Overall, 9 were discharged after the procedure and none of these required long-term circulatory support or conversion to open heart surgery. One patient has never been discharged and died in-hospital six months later due to CS.
3-months follow-up
For a patient, 3-months follow-up was unavailable at the time of this preliminary analysis.
Among others, 4 (44.4%) patients had NYHA functional class II. Loop diuretic dose was 75 mg/die (50-88). MR grade was 2+ in 5 (55.6%) patients. Median EF and PASP was 30% (22-35) and 50 mmHg (42-60), respectively. The mean transmitral gradient was 3 mmHg (2-3).
Primary and secondary endpoints are shown in table 4.
One patient died due to HF. Throughout survived, one patient required durable LVAD implantation and another was treated with persistent inotropic support.
6-months follow-up
Of 8 patients, 4 (50%) had MR grade 2+ and 5 (62.5%) a NYHA class II. Loop diuretic dose was 63 mg/die (31-75). Median EF was 28% (26-36) whereas PASP, available for 6 patients, was 51 mmHg (44-58).
Primary and secondary endpoints are presented in table 4.
Notably, from the index MitraClip® procedure, 2 patients needed durable LVAD implantation and 2 others died.
1-year follow-up
At the time of this preliminary analysis, 1-year follow-up was not ready for 2 patients.
MR reduction and NYHA functional improvement from baseline to 1-year follow-up are presented in figure 2.
Median EF and PASP, handy for 4 patients, was 25 % (23-26) and 50 mmHg (39-65), respectively. Primary and secondary endpoints are shown in table 4.
At 1-year, three patients died. Among survived, 3 patients required long-term LVAD implantation, of which one underwent orthotopic cardiac transplantation (Figure 3).
Discussion
The need for a less invasive therapeutic strategy for patients with SMR complicated by LCOS or CS early after an AMI and at high surgical risk, prompted the scientific community to evaluate the efficacy and safety of TMVR.
Nowadays, TMVR with MitraClip system is FDA approved for patients with degenerative MR at high surgical risk and favorable anatomy, as well as in selected patients with severe SMR in the setting of symptomatic chronic HF despite GDMT15,25–27. On the contrary, its use in infarct related acute settings, is limited to case reports, small case series and registry20–22,28,29.
Moreover, there are reservations for the use of MitraClip® in this setting given the risk of papillary rupture with leaflet detachment and the lack of data in support of MR severity following revascularization once the myocardium is revitalized29.
We report 10 patients treated with MitraClip® implantation in this context. Most of the patients included had a significant LV dysfunction and were on inotropic or mechanical circulatory support prior to the procedure which, together with multiple comorbidities, made them at high operative risk. Despite these adverse features, TMVR proved to be feasible and likely effective in the short-term with potential positive hemodynamic effect as highlighted by the reduced need for circulatory support, loop diuretic dose and NT-proBNP values after the procedure. Only 40% of patients were treated with levosimendan prior the procedure, pointing out the need for future research to increase the evidence on its use in acute settings.
Interestingly, 60% of patients had left main or left anterior descending infarct-related artery while in literature the most frequently involved artery are right coronary and left circumflex4. This is associated with a more extensive LV remodeling and, although MR grade reduction and NYHA class improvement persist to 1-year follow-up (figure 2), no contextual benefit on LV systolic function and PASP was seen, indicating a poor effectiveness of the procedure on LV reverse remodeling. This may be in agreement with the hypothesis that treating the mitral valve in a
background of a primary ventricular disease does not change its natural history, especially when we are faced with advanced heart disease.
In support of what has been said, at 1-year follow-up, 3 out of 8 patients died and other 3 required heart replacement therapies.
In our cohort only one patient had an immediate unsuccessful procedure and it was not converted to open heart surgery due to its high operative risk.
We can therefore speculate that in this context MitraClip® implantation should be considered more as a ‘palliative procedure’ or a bridge to heart replacement therapies in patients with advanced heart disease rather than a definitive treatment.
Limitations
Our study has limitations common to observational retrospective studies such as selection bias and small sample size, all of which limit the external validity.
Moreover, we have enrolled patients in a wide period of time, during which the management of SMR post-AMI changed significantly, thanks to new option of care; these changes could have affected clinical outcomes.
For all these reasons our result should be regarded as hypothesis generating instead of a consistent and definitive result.
Conclusions
Despite recent therapeutics innovations, acute SMR complicated by LCOS secondary to AMI remain a deadly affection. In selected patients, TMVR with MitraClip® device is feasible and safe but, until now, we do not have sufficient data to state that this procedure could improve clinical outcome. Our analysis revealed how MitraClip® procedure could represent a bridge therapeutic strategy to heart replacement therapies in patients with more advanced heart disease but not a definitive treatment in order to allow recovery and healing.
What is new?
In literature we have only scarce data regarding the beneficial effect on outcome of MitraClip® procedure in patients with infarct related acute SMR complicated by LCOS.
When considering TMVR in this setting, we should think that this is more a ‘palliative strategy’ rather than a definitive treatment. Doing so, we have to consider eligible for this procedure only patients who are supposed to receive heart replacement therapies, known to improve survival.
References
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Tables and figures Characteristics Total n = 10 Age, years 64.1 ± 12.8 Male, n (%) 5 (50) Hypertension, n (%) 8 (80) Diabetes, n (%) 2 (20) Dyslipidaemia, n (%) 5 (50) CKD, n (%) 4 (40) Smoker, n (%) 3 (30) Extracardiac arteriopathy, n (%) 3 (30) Atrial fibrillation, n (%) 3 (30) COPD, n (%) 0 Permanent pacemaker, n (%) 2 (20) Previous CRT, n (%) 1 (10) Previous PCI, n (%) 5 (50) Previous CABG, n (%) 3 (30)
NYHA functional class, n (%)
I 0
II 2 (20)
III 3 (30)
IV 5 (50)
Table 1. Baseline clinical characteristics.
Values are median (interquartile range), frequencies (percentages), or mean ± SD.
ACEi, Angiotensin Converting Enzyme Inhibitors; ARB, Angiotensin II Receptor Blockers; ARNI,
Angiotensin Receptor-Neprilysin Inhibitors; CABG, Coronary Artery Bypass Graft; CKD, Chronic
Kidney Disease; COPD, Chronic Obstructive Pulmonary Disease; CRT, Cardiac Resynchronization Therapy; IABP, Intra-Aortic Balloon Pump; LV, Left Ventricle; MRAs,
Mineralocorticoid Receptor Antagonists; NYHA, New York Heart Association; PCI, Percutaneous
Coronary Intervention; STS, Society of Thoracic Surgeons; VA ECMO, Veno-Arterial
ExtraCorporeal Membrane Oxygenation.
Primary angioplasty, n (%) 6 (60)
Culprit vessel, n (%)
Left Main 3 (30)
Left anterior descending 3 (30) Left Circumflex 4 (40)
Right coronary 0
Undetermined 0
Multivessel disease, n (%) 6 (60)
Pre-TMVR (n = 10) Discharge (n = 10) LVEF, % 31 (25 - 40) a 28 (25 - 37) MR severity 1+ 2+ 3+ 4+ 0 0 2 (20%) 8 (80%) 4 (40%) 4 (40%) 1 (10%) 1 (10%) EROA, cm2 b 0.40 (0.37 - 0.46) / TR severity, + 1 (1 - 2) a 2 (1 – 2) TAPSE, mm 17 (15 - 18) a 17 (16 - 19) PASP, mmHg 40 (37 - 58) a 42 (40 - 58)
Table 2. Baseline and discharge echo parameters.
Values are median (interquartile range) and frequencies (percentages). No EROA values post clip were reported.
a
data available for 9 patients.
b data available for 8 patients.
EROA, Effective Regurgitant Orifice Area; LVEF, Left Ventricular Ejection Fraction; MR, Mitral
Regurgitation; PASP, Pulmonary Artery Systolic Pressure; TAPSE, Tricuspid Annular Plane
pre-TMVR (n = 10) 48h post-TMVR (n = 10) Medical Therapy a ACEi/ARBs, n (%) 5 (50) 5 (55.6) Beta-Blockers, n (%) 6 (60) 7 (77.8) MRAs, n (%) 3 (30) 6 (66.7) ARNI, n (%) 0 0
Loop diuretic dose, mg/die 80 (60 - 156) 60 (50-80)
Vasoactive agents a None, n (%) 2 (20) 6 (67) SNP, n (%) 6 (60) 2 (22.2) Epinephrine, n (%) 3 (30) 2 (22.2) Norepinephrine, n (%) 3 (30) 0 Dopamine, n (%) 1 (10) 0 Dobutamine, n (%) 2 (20) 1 (11.1) Levosimendan, n (%) 4 (40) 0 Short MCS IABP, n (%) 4 (40) 2 (20) Impella, n (%) 0 0
Veno arterial EMCO, n (%) 0 0
Mechanical ventilation, n (%) 3 (30) 2 (20) Laboratory Parameters a Creatinine, mg/dl 1.2 (1.0 – 1.4) 1.2 (1.1 – 1.4) Bilirubin, mg/dl b 0.8 (0.5 – 1.0) 0.8 (0.4 – 1.0) Hemoglobin, g/dl 10.1 (9.4 – 10.8) 9.1 (8.4 – 9.8)
Table 3. Clinical and laboratory parameters pre- and 48 hours after MitraClip® procedure. a
ACEi, Angiotensin Converting Enzyme Inhibitors; ARB, Angiotensin II Receptor Blockers; ARNI,
Angiotensin Receptor-Neprilysin Inhibitors; IABP, Intra-Aortic Balloon Pump; LVEF, Left
Ventricular Ejection Fraction; MCS, Mechanical Circulatory Support; MR, Mitral Regurgitation;
MRAs, Mineralocorticoid Receptor Antagonists; PASP, Pulmonary Artery Systolic Pressure; PDE3-I, PhosphoDiEsterase-3-Inhibitor; SNP, Sodium Nitroprusside; TM, Trans-Mitral; TMVR,
3-months (n = 9) 6-months (n = 9) 1-year (n = 8) Primary endpoint, n (%) 5 (55.6) 6 (66.7) 7 (87.5) Secondary endpoints Death, n (%) 1 (11.1) 2 (22.2) 3 (37.5) HF hospitalization, n (%) 4 (44.4) 4 (44.4) 5 (62.5)
Conversion to cardiac surgery, n (%) 0 0 0
Need for long-term HRT, n (%)
Durable LVAD 1 (11.1) 2 (22.2) 3 (37.5) Orthotopic HTx 0 0 1 (12.5) Persistent inotropic support, n (%) 1 (11.1) 1 (11.1) 1 (12.5)
Table 4. Primary and secondary endpoints.
HF, Heart Failure; HRT, Heart Replacement Therapies; HTx, Heart Transplant; LVAD, Left
Figure 1. Decisional flow-chart.
AMI, Acute Myocardial Infarction; HTx, Heart Transplant; MR, mitral regurgitation; SMR,
Figure 2. MR and NYHA functional class changes from baseline to 1-year follow-up.
Figure 3. Patients outcome at 1-year.
