|Year : 2023 | Volume
| Issue : 1 | Page : 29-40
Transcatheter mitral valve repair in acute and critical cardiac conditions
Rasha Kaddoura1, Mohammed Al-Hijji2
1 Department of Pharmacy, Heart Hospital Hamad Medical Corporation, Doha, Qatar
2 Department of Adult Cardiology, Heart Hospital Hamad Medical Corporation, Doha, Qatar
|Date of Submission||14-Aug-2022|
|Date of Acceptance||22-Jan-2023|
|Date of Web Publication||23-Feb-2023|
Dr. Rasha Kaddoura
Department of Pharmacy, Heart Hospital, Hamad Medical Corporation, P. O. Box 3050, Doha
Source of Support: None, Conflict of Interest: None
| Abstract|| |
Acute mitral valve regurgitation (MR) is an emergency condition that requires an early diagnosis of the etiology and rapid management. Surgical intervention is the first-line treatment for acute severe MR. However, many patients are denied surgical intervention due to the acute risk of surgery. Transcatheter mitral valve repair (TMVr) is a less invasive technique and becoming a potential alternative to surgery in inoperable patients but is underrepresented in the literature. This review aims to discuss the published data on the use of TMVr in unstable MR patients presenting with acute or critical cardiac conditions.
Keywords: Cardiogenic shock, decompensated heart failure, MitraClip®, mitral regurgitation, papillary muscle rupture, percutaneous mitral valve intervention, transcatheter edge-to-edge repair
|How to cite this article:|
Kaddoura R, Al-Hijji M. Transcatheter mitral valve repair in acute and critical cardiac conditions. Heart Views 2023;24:29-40
| Introduction|| |
Mitral valve regurgitation (MR) is one of the most common valvular disorders in patients with heart valvular diseases. The estimated prevalence is approximately 1.7% in the United States, which increases with increased age, approaching 10% in individuals older than 75 years of age. Severe MR, if left untreated, carries poor clinical prognosis, reduced quality of life, and higher risk for morbidity and mortality regardless of etiology or lesion type. Although surgical intervention is strongly recommended for symptomatic severe MR, a pan-European survey found that 49% of these patients were denied intervention, especially in acute and critical conditions. Half of the medically treated patients with severe MR die within 5 years and a significant number of them are hospitalized for heart failure.
Transcatheter mitral valve repair (TMVr) using the MitraClip® (Abbott, Plymouth, MN) or PASCAL (Edwards Lifesciences, Irvine, CA) devices has been clinically approved as alternative options to treating severe MR in inoperable or high surgical risk patients., In patients with chronic functional MR, TMVr significantly reduced hospitalization for heart failure and all-cause mortality by 47% and 38%, respectively, in comparison with optimal medical therapy alone at two-year follow-up. However, clinical trials and registries have only enrolled clinically stable chronic MR patients. In the ACCESS-EU (ACCESS-Europe A Two-Phase Observational Study of the MitraClip System in Europe) study, 4.9% of participants were in cardiogenic shock at the time of MitraClip® implantation. Moreover, 7% of patients with cardiogenic shock have severe MR as reported in the SHOCK trial registry.
TMVr has increasingly been performed in hemodynamically unstable and inoperable MR patients. While the benefit of TMVr on procedural and clinical outcomes in chronic severe MR patients has been established, there is limited evidence in those presenting with acute MR who were excluded from clinical trials.
Herein, this article aims to review the published data and explore patient characteristics as well as procedural and clinical outcomes in unstable MR patients presenting with acute or critical cardiac conditions.
| Acute Mitral Regurgitation|| |
Acute MR is an emergent clinical condition leading to severe acute decompensated heart failure (ADHF) due to sudden elevation of pressure and volume load on the left atrium and acute reduction in cardiac output. According to a large study (n = 89,085) utilizing the Society of Thoracic Surgery (STS) database, the etiology of acute or chronic MR was categorized into the following groups: endocarditis, acute ischemic MR, uncommon aetiologies, degenerative primary MR, chronic ischemic MR, and pure annular dilatation.
Primary acute MR occurs due to spontaneously ruptured chordae tendineae, papillary muscle rupture (PMR), infective endocarditis, or myxomatous degeneration of the leaflet and chordae.
Less common causes of acute MR include chest trauma, systemic inflammatory diseases, rheumatic fever, or systolic anterior motion mitral leaflet in Takotsubo cardiomyopathy. Ischemic PMR complicating acute myocardial infarction (MI) leads to acute heart failure and severe hemodynamic instability and is usually fatal., PMR in the context of acute MI occurs in 1%–5% of patients, leading to 5% of MI-related deaths. The ruptures usually occur within 7 days of the ischemic event in up to 80% of patients. Acute MR complicating acute MI can also occur without PMR because of the sudden left ventricular (LV) dysfunction that may cause leaflet tethering. [Figure 1] summarizes the clinical, hemodynamic, and diagnostic characteristics of acute MR.,,,
|Figure 1: Clinical, hemodynamic, and diagnostic characteristics of acute mitral regurgitation. Panel A: Characteristics details; Panel B: Basic mechanisms leading to symptoms. ACS: Acute coronary syndrome; AV: Aortic valve, CO: Cardiac output, CS: Cardiogenic shock, CVP: Central venous pressure, LVEF: Left ventricular ejection fraction, LA: Left atrial/atrium, LV: Left ventricle/ventricular, LVEDP: Left ventricular end-diastolic pressure, MR: Mitral valve regurgitation, MV: Mitral valve, PMR: Papillary muscle rupture, RV: Regurgitant volume, SV: Stroke volume|
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The key to management is dependent on the early recognition of MR and identification of the etiology of valvular dysfunction. However, there is not a universal consensus on therapy., Surgical correction is preferred if the mitral valve apparatus is mechanically disrupted, such as PMR, ruptured chordae, or infective endocarditis. The general approach to the management of acute MR is illustrated in [Figure 2].,,, Pharmacological or mechanical circulatory support (MCS) can be a bridge to recovery or surgery if surgery deems unsuitable for a critically ill patient. On the other hand, surgical intervention in acute MR is associated with high perioperative mortality.
|Figure 2: General approach to the management of acute mitral regurgitation. CAG: Coronary angiogram, CXR: Chest X-ray, ECG: Electrocardiogram, HF: Heart failure, MR: Mitral valve regurgitation, MV: Mitral valve, PMR: Papillary muscle rupture, TEE: Transesophageal echocardiogram, TTE: Transthoracic echocardiogram|
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The majority of patients with cardiogenic shock due to severe MR complicating acute MI in the SHOCK trial registry did not undergo mitral valve surgical intervention. Whereas 39% of those who were operated on have died. TMVr using the edge-to-edge repair technique is a feasible option in inoperable critically ill patients with acute MR given the limited alternatives. It reduces MR, alleviates heart failure symptoms, and enhances beneficial LV remodeling. In addition, it allows LV unloading by reducing LV end-diastolic pressure and end-diastolic volume. As TMVr reduces MR, it improves intraprocedural cardiac output state and hemodynamics immediately after device implantation. In this regard, it has an advantage over surgery since the latter tends to increase LV afterload which impairs LV function and results in a low cardiac output state postoperatively.
| Published Literature|| |
Through an electronic literature search, 49 publications have been identified. The publications comprised 23 case reports,,,,,,,,,,,,,,,,,,,,,,, 16 case series,,,,,,,,,,,,,,,, and ten observational studies.,,,,,,,,, The majority were in the setting of cardiogenic shock, acute MI, and acute heart failure or pulmonary edema. One case report was in the setting of infective endocarditis with cardiogenic shock. The definitions used in the studies are presented in [Table 1].
| Case Reports and Case Series|| |
Several case reports and case series highlighted the feasibility and safety of TMVr in unstable inoperable patients in acute or critical settings such as cardiogenic shock. In the 23 single clinical cases, most of the reports included patients who presented with or developed cardiogenic shock which required inotropic agents and/or MCS. Of the 23 cases, 15 presented with acute MI,,,,,,,,,,,,,, and nine of them experienced PMR.,,,,,,,, Of the 16 case series, six reported a total of 27 hemodynamically unstable patients narratively.,,,,, Overall, there were procedural success, shock resolution, and improvement in symptoms, hemodynamic parameters, and MR grade. Six of them died due to noncardiac causes except for one case that died due to sudden cardiac death.,,,
| Descriptive Studies|| |
Ten publications of the remaining 20 aimed to describe the characteristics and outcomes of unstable patients at prohibitive surgical risk who underwent TMVr for moderate-to-severe or severe MR (i.e., MR grade 3+ or 4+) between 2010 and 2020.,,,,,,,,,
The studies confirmed the feasibility and safety of TMVr approach in acute and critical cardiac settings. Half of the studies enrolled patients with cardiogenic shock in various settings such as acute MI, labile hemodynamic stability, and acute decompensated or refractory heart failure.,,,,,, One study recruited patients early following acute MI and another two, allowed recruitment within 90 days of the acute coronary event. The TMVr procedure was performed at approximately a mean of 30 days after the index MI event., [Table 2], [Table 3], [Table 4], [Table 5] summarize the key patient and echocardiographic characteristics as well as the outcomes, both procedural and clinical.
Patients' age across the ten studies ranged from 65 to 74 years old, with 60% male patients in average. Patients had multiple comorbidities and high surgical risk scores. History of admission due to heart failure was frequent; 90% were admitted frequently within 6 months before the procedure in one study. Functional MR was more prevalent (range 50%–90%) than degenerative MR (range 7%–64%). Similarly, ischemic cardiomyopathy was more frequent (range 35%–85%) than non-ischemic etiology (13%–65%). Patients were symptomatic upon presentation (New York Heart Association (NYHA) class IV, 64%–100%). Inotropic and mechanical support was required in 40%–94% and 14%–50% of patients, respectively. Intra-aortic balloon pump (IABP) was the most frequently used device.
Echocardiographic characteristics and outcomes
At baseline, MR grade was quantified as grade 4+ or severe in 75%–90% of patients. In the majority of studies, ejection fraction was moderate-to-severely impaired (range 30%–36%) and systolic pulmonary artery pressure was elevated (range 47–60 mmHg). After the MitraClip® procedure, the number of clips implanted ranged from 1 to 3 with a device failure rate of 0%–11%. In most cases, MR grade was reduced from 4+ to 2+ or less (range 73%–95%).
In-hospital mortality was reported in 5%–30% of patients. All-cause mortality at 6 months or longer of follow-up occurred in 15%–67% of patients. Higher mortality rates were observed in the studies with a small sample size. The length of stay after the procedure was 3–10 and 10–40 days, in the intensive care unit and hospital, respectively. In one study, NYHA class I/II and MR grades of 2+ or less were observed in more than 70% of patients at 6-month follow-up. When comparing patients with device success to those without it, the successful procedure was associated with significantly lower in-hospital mortality (hazard ratio (HR) 0.36; 95% confidence interval [CI] 0.13–0.98, P = 0.04), 90-day mortality (HR 0.36; 95% CI 0.16–0.78, P = 0.01), and one-year mortality (HR 0.46; 95% CI 0.22–0.94; P = 0.03). In addition, hospitalization for heart failure (HR 0.20; 95% CI 0.06–0.73; P = 0.01) and the composite of 90-day mortality and hospitalization (HR 0.41; 95% CI 0.19–0.90; P = 0.03) were significantly lower as well.
| Mitraclip® Use Versus No-Use or Surgery|| |
Using a nationwide database, Tang et al. have shown that the use of TMVr in MR patients (n = 596) presenting with cardiogenic shock has increased (P < 0.001) with favorable clinical outcomes when compared with a matched patient cohort who were managed medically (n = 596). MitraClip® use was correlated with significantly lower in-hospital mortality (odds ratio 0.6; 95% CI 0.47 – 0.77; P < 0.001) and 1-year mortality (HR 0.76; 95% CI 0.65 – 0.88, P < 0.001) compared with no use. Another analysis of data from the Nationwide Readmissions Database included patients who underwent TMVr using MitraClip® (n = 222) or mitral valve surgery (n = 4738) during the acute or subacute phase of acute MI. The cardiogenic shock occurred in approximately 30% of the patients in each group. Although MitraClip® was less commonly used in acute MI, its utilization increased from 2014 to 2017, while surgical cases remained relatively stable. There was similar in-hospital mortality (14.4% versus 14.1%) and 30-day any-cause readmission (22.8% versus 21.4%) rates but higher 30-day heart failure readmission rates among TMVr patients (8.8% versus 4.4%).
| Factors Affecting Transcatheter Mitral Valve Repair Outcomes|| |
Impact of shock
Flint et al. reported results that are consistent with the previous reports on the successful utilization of TMVr in patients presenting with cardiogenic shock secondary to acute MR and/or acute MI (n = 12). In addition, when compared with patients with cardiomyopathy admitted due to their long-standing MR progression (n = 123) but without shock, cardiogenic shock patients experienced a higher mortality rate within one month of TMVr (17% versus 3%, P = 0.03). In the IREMMI (The International Registry of MitraClip in Acute Mitral Regurgitation following acute MI) Registry, however, patients with acute MR due to acute MI (n = 93), had comparable outcomes following TMVR with MitraClip® device regardless of their presentation with cardiogenic shock (n = 50) or not (n = 43). The rates of 30-day mortality (10% versus 2.3%, P = 0.212), 30-day rehospitalization for heart failure (13% versus 23%, P = 0.253), and the composite of mortality and rehospitalization at 7-month follow-up (28% versus 25.6%, P = 0.793) did not differ between groups, respectively. The results might be influenced by the small sample size in both groups.
Impact of acute myocardial infarction
Cardiogenic shock patients (n = 639) from the Nationwide Readmissions Database who underwent TMVr were divided into two cohorts according to the presence of acute MI (n = 179) or not (n = 460). Acute MI patients were more likely to require MCS (60.3% versus 25.7%, P < 0.001) and experience in-hospital mortality (29.6% versus 20.4%, P0.02) compared to those without acute MI.
Impact of the clinical and procedural status
A study by Lee et al. reported that cardiogenic shock patients presented with a critical condition and underwent emergent TMVr (n = 8) had higher surgical risk (STS score 19.7% versus 5.1%, P < 0.001; EuroSCORE II 34.8% versus 5.1%, P < 0.001) and poorer outcomes in comparison with those who underwent the elective procedure (n = 42). Critical patients had a lower probability of survival (P = 0.008) at one-year follow-up. Emergent TMVr (HR 6.873; 95% CI 1.377 – 34.306, P = 0.019) and STS score (HR 1.091; 95% CI 1.023 – 1.165, P = 0.008) were associated with one-year mortality. However, only the STS score was correlated with long-term survival (HR 1.091; 95% CI 1.023 – 1.165). Findings from a prospective registry, however, showed no difference in procedural or clinical outcomes between unstable patients admitted with ADHF and underwent urgent TMVr for acute or decompensated longstanding MR (n = 17) and stable patients electively treated with TMVr (n = 68) (EuroSCORE II 13.6% versus 4.6%, P = 0.002, respectively).
In another study (n = 237), TMVr outcomes of patients with severe MR (n = 46) and high surgical risk (EuroSCORE II 15.9%) hospitalized for ADHF were compared with that of elective patients (EuroSCORE II 9.0%, P = 0.01). ADHF patients had significantly higher rates of in-hospital mortality (10.9% versus 2.6%, P = 0.026) and 30-day mortality (10.9% versus 3.1%, P = 0.042), but not one-year mortality (21.7% versus 17.9%, P = 0.49) or one-year rehospitalization for heart failure (33% vs. 20%, P = 0.09).
EuroSCORE II was a predictor for both 30-day mortality (risk ratio 1.08, 95% CI 1.02 – 1.14, P < 0.01) and one-year mortality (HR 1.03, 95% CI 1.0 – 1.05, P = 0.05). In this study, 37% of ADHF patients were in the critical condition.
| Transcatheter Mitral Valve Repair-Mechanical Circulatory Support Combined Approach|| |
Eliaz et al. published a case series of four patients with severe MR who presented with worsening heart failure due to acute MI, respiratory failure, or rheumatic MR. The investigators inserted IABP before TMVr to allow for overcoming the mitral leaflet gap and achieving sufficient leaflet coaptation. By reducing the pre- and afterload and consequently decreasing oxygen consumption, wall tension of the LV, and systolic pressure, in addition to elevating diastolic pressure, IABP can permit temporary remodeling of the mitral valve apparatus which may enhance coaptation. Although the procedure was successful in all patients, one of them died due to multiorgan failure.
Vandenbriele and colleagues in their exploratory study on six INTERMACS-1 (interagency registry for mechanically assisted circulatory support scale) cardiogenic shock patients with acute MR (EuroSCORE II score 39%) concluded that an approach of combining TMVr with an Impella® device was feasible and safe to weaning invasive ventilation in cardiogenic shock patients with high surgical risk. The severity of MR was reduced from severe to mild in all patients. One patient died due to multi-organ failure, and two were re-hospitalized for mild heart failure due to atrial fibrillation at a 6-month follow-up and were successfully managed.
| Discussion|| |
Acute MR is a medical emergency that necessitates an early precise diagnosis of the etiology and MR severity for successful management. Surgical intervention is considered the first-line treatment for acute severe MR.
TMVr is a less invasive approach and has been successfully used as an alternative therapy in patients with high surgical risk. As robust data is lacking, the management of acute MR using TMVr is mostly based on experts' opinion. Most of the reports presented in this review included inoperable patients presented with cardiogenic shock, ADHF, and acute MI including those with PMR. The reports confirmed the feasibility and safety of the transcatheter approach. Similarly, Pooled data from 40 publications was based, except for one study, on case reports and case series of critically ill patients undergoing TMVr (n = 254) and investigated their baseline characteristics and outcomes. The mean age of the patients was 70 years who presented with severe MR (grade 4+ in 91%) and high surgical risk (i.e., EuroSCORE II of 21% and STS of 20.5%). The most frequent clinical presentation was a cardiogenic shock (72.8%) followed by acute MI (60%). Successful procedure (i.e., MR grade ≤2+) was reported in 91.8% of patients whereas 12.6% died in the hospital. At 12 months follow-up, 81.3% of patients maintained an MR grade of 2+ with a 39.1% overall mortality rate.
In the absence of data, a Heart Team or a multidisciplinary team including experts in structural heart disease should individualize TMVr approach by basing the decision on various aspects such as procedural risk, clinical presentation, cardiac function, risk assessment, and mitral valve morphology.,,
Currently, most of the relevant international guidelines do not have a recommendation on the use of TMVr approach in acute MR.,, Others acknowledged the limited available data on its use in less common clinical conditions such as cardiogenic shock., Finally, randomized controlled trials comparing surgical with transcutaneous interventions in acute MR may not be feasible in critically ill patients, therefore, adequately designed prospective observational trials are definitely needed.
| Conclusion|| |
Surgical intervention remains the gold standard for treating acute MR, but half of the patients are usually denied surgery. TMVr evolved as a viable alternative in patients with high surgical risk. The reports are accumulating on the safety and feasibility of TMVr with MitraClip® device leading to immediate and persistent improvement of MR. Mortality benefit has been observed. A heart team can provide a comprehensive assessment of the eligibility of TMVr approach in patients with hemodynamic instability. Until larger studies address the applicability and the limitations of the transcatheter edge-to-edge repair technique, the decision of utilization will remain based on the physician's opinion and expertise.
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Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2]
[Table 1], [Table 2], [Table 3], [Table 4], [Table 5]