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Despite improvements in outcomes in the last few decades for heart failure (HF) with reduced ejection fraction (HFrEF), there still remains a need for novel therapies as many patients incompletely recover with existing therapies and progress to advanced HF. In this review, we will discuss recent advances in the management of HFrEF with a focus on upcoming therapies that hold the greatest promise for clinical use. We will discuss novel pharmacological therapies and areas of uncertainty with existing therapies. We will also discuss the potential utility and controversy surrounding novel interventions for HF such as percutaneous mitral valve repair, atrial fibrillation ablation, and other emerging interventions with positive signals for benefit in HFrEF. Finally, we will summarize the current state of stem cell and gene therapy for HFrEF and future directions.

Aims The aim of this study is to evaluate changes in cardiopulmonary exercise test (CPET) after percutaneous mitral valve repair (PMVR) with MitraClip in patients with heart failure with reduced ejection fraction who are potentially candidates for heart transplantation or destination left ventricular assist device. Methods and results Prospective registry of all consecutive patients with heart failure with reduced ejection fraction and functional mitral regurgitation (MR) underwent elective PMVR between October 2015 and March 2018 in our institution. Patients with preserved or mid‐range left ventricular ejection fraction (>40%), advanced age (>75 years old), or severe co‐morbidities (end‐stage organ damage) were not included. Treadmill exercise testing with respiratory gas exchange analysis was carried out in 11 patients (male, 72.7%; median age, 67 years old) within the month prior to the procedure and at 6 month follow‐up. PMVR was successfully performed in all patients. At 6 month follow‐up, PMVR was associated with an improvement in New York Heart Association functional class (P = 0.021) and a reduction in MR severity (P = 0.013) and N‐terminal pro‐brain natriuretic peptide levels (2805 [1878–5022] vs. 1485 [654–3032] pg/mL; P = 0.012). All patients completed pre‐procedural and post‐procedural CPET, and all the studies showed a respiratory exchange ratio ≥1 and were consistent with sufficient exercise effort. Compared with pre‐procedural CPET, patients showed a significant increase in exercise time (295 [110–335] vs. 405 [261–540] s; P = 0.047), VO2 (9.8 [9.1–13.4] vs. 13.5 [12.1–16.8] mL/kg/min; P = 0.033), ventilatory anaerobic threshold (510 [430–950] vs. 850 [670–1070] mL/kg/min; P = 0.033), peak O2 pulse (7.2 [4.3–8.6] vs. 8.3 [6.2–11.8] mL/beat; P = 0.033), and workload (5 [3–6] vs. 6 [5–8] metabolic equivalents; P = 0.049). Conclusions Percutaneous mitral valve repair with MitraClip was associated with an enhancement in cardiopulmonary performance in patients with systolic heart failure and secondary MR.

Heart failure (HF) is an increasing pandemic affecting more than 26 million people worldwide. Despite growing therapeutic options, the outlook of…, Heart failure (HF) is an increasing pandemic affecting more than 26 million people worldwide. Despite growing therapeutic options, the outlook of patients with HF remains particularly poor with high mortality and rehospitalization rates. When HF remains uncontrolled despite optimal medical therapy, mechanical circulatory devices or heart transplantation must be considered. Unfortunately, these therapeutic options are limited. This case explains how consecutive minimally invasive treatment allowed stabilization of end-stage HF thereby avoiding heart transplantation or mechanical assist devices. (Level of Difficulty: Intermediate.), Graphical abstract

Infective endocarditis following a Mitraclip procedure might be an under-recognized complication. We describe the case of infective endocarditis by Bartonella henselae as a late complication in a patient with a previously implanted MitraClip system for mitral valve repair. Due to the severity of infection, surgical treatment was performed despite the high preoperative surgical risk, but recurrence of endocarditis of the biological valve implanted occurred. Although infection with Bartonella is known as a possible source of endocarditis, it has never been described before in relation to failed MitraClip therapy.

Percutaneous mitral valve repair is emerging as a reasonable alternative especially in those with an unfavorable surgical risk profile in the repair of mitral regurgitation. At this time, our understanding of the effects of underlying renal dysfunction on outcomes with percutaneous mitral valve repair and the effects of this procedure itself on renal function is evolving, as more data emerges in this field. The current evidence suggests that the correction of mitral regurgitation via percutaneous mitral valve repair is associated with some degree of improvement in cardiac function, hemodynamics and renal function. The improvement in renal function was more significant for those with greater renal dysfunction at baseline. The presence of Chronic Kidney Disease (CKD) in turn has been associated with poor long-term outcomes including increased mortality and hospitalization among patients who undergo percutaneous mitral valve repair. This was true regardless of the degree of improvement in GFR post repair advanced CKD. The adverse impact of CKD on long-term outcomes was consistent across all studies and was more prominent in those with GFR

BACKGROUND The effects of edge-to-edge percutaneous mitral valve repair on the shape and size of the mitral annulus and its relation to mitral regurgitation (MR) have not been well characterized. We evaluated acute changes in mitral annular shape and dimensions, and their effect on MR severity, in patients with functional and degenerative MR following MitraClip® . METHODS Patients that underwent MitraClip® between January 2013 and May 2016 at our institution were retrospectively reviewed. EXCLUSIONS inadequate images, prior mitral valve repair, and rapid atrial fibrillation. Intra-procedure TEE 3D images acquired prior to and after implantation of MitraClip® were analyzed using software to model the mitral valve apparatus. RESULTS Of seventy-eight patients that underwent MitraClip® procedure, 60 were eligible. Mean age was 78.3 ± 11 years. Severe MR (4+) was present in 37 patients, moderately/severe MR (3+) in 23. All patients achieved MR reduction to ≤2. 3D annular circumference, bicommissural diameter, and anteroposterior diameter had a significant size reduction after MitraClip® . None of the mitral annular measures had significantly different mean change between the large and small MR change groups at the 0.05 significance level. CONCLUSIONS In patients with functional or degenerative MR, the MitraClip® significantly affect mitral annular dimensions; however, these changes do not correlate with the immediate MR reduction.

Background: High-risk patients with mitral regurgitation (MR) may be treated by a percutaneous mitral valve repair with the MitraClip, but identification of patients who may benefit remains difficult. We aimed to determine whether myocardial fibrosis predicts outcome in MR patients undergoing MitraClip implantation and is beneficial in clinical decision making. Methods: Preprocedural to the MitraClip implantation, myocardial fibrosis was analyzed with cardiovascular magnetic resonance (CMR) through late gadolinium enhancement. The CMR data were core-lab adjudicated measured before the MitraClip implantation. Adverse outcome was defined as New York Heart Association (NYHA) class III or IV after 1 month or death within 1 month after the MitraClip implantation. Results: In total, 23 patients underwent preprocedural CMR, mean age 80 ± 9 years, 45% male, 64% atrial fibrillation and 73% NYHA class III or IV at baseline. Myocardial fibrosis was present in 55% of the patients with degenerative MR and in 64% of the patients with functional MR. An adverse outcome occurred in 69% of the patients with myocardial fibrosis and in 11% of the patients without myocardial fibrosis (P = 0.01). Conclusions: Our hypothesis-generating study showed that the presence of myocardial fibrosis predicts adverse outcome in patients undergoing MitraClip implantation. After confirmation with larger sample size, identification of myocardial fibrosis might contribute to assess prognosis and to clinical decision making.

Cardiac tamponade (CT) is a rare but often life-threatening complication after invasive cardiac procedures. Some procedures favor CT. Furthermore, the incidence depends on patients’ comorbidities, sex and age and operators’ skills. In this paper we review studies and meta-analyses concerning the rate of iatrogenic CT. We define the risk factors of CT and show concise characteristics for each invasive cardiac procedure separately. According to our analysis CT occurs especially after procedures requiring transseptal puncture or perioperative anticoagulation. The overall rate of CT after such procedures varies among published studies from 0.089% to 4.8%. For this purpose we searched the PubMed database for clinical studies published up to December 2018. We included only those studies in which a defined minimum of procedures were performed (1000 for atrial fibrillation ablation, 6000 for percutaneous coronary intervention, 900 for permanent heart rhythm devices, 90 for left atrial appendage closure, 300 for transcatheter aortic valve implantation and percutaneous mitral valve repair with the Mitra-Clip system). The search was structured around the key words and variants of these terms. In addition, secondary source documents were identified by manual review of reference lists, review articles and guidelines. The search was limited to humans and adults (18+ years).

Amyloidosis is an infiltrative disease with severe impact on the cardiac anatomy resulting in structural changes 1 . Mitral valve insult from the infiltrative process, although rare, has been known to cause severe mitral regurgitation 4 . Due to underlying comorbidities these patients may not be surgical candidates. 17 , 18 , 19 , 20 The role of percutaneous mitral valve repair in cardiac amyloidosis has been described in a few prior cases. 4 , 15 We review the epidemiology, diagnosis, and treatment of cardiac amyloidosis. We also highlight prior cases described in the literature of cardiac amyloidosis and severe mitral regurgitation, while discussing the role of percutaneous mitral valve repair in these patients.

Background Optimizing risk stratification in patients undergoing transcatheter mitral valve repair is an ongoing challenge. The Mitral Regurgitation International Database (MIDA) score represents a user‐friendly mortality risk stratification tool that is validated on a large‐scale registry of patients with degenerative mitral regurgitation (MR). We here assessed the potential benefit of the MIDA risk score for patients with functional or degenerative MR undergoing transcatheter mitral valve repair. Methods and Results In total, 680 patients undergoing MitraClip implantation were stratified according to MIDA score tertiles into a low (0–7), intermediate (8–9), and a high (10–12) MIDA score group. MR was assessed in follow‐up echocardiograms in 416 patients at 323±169 days after transcatheter mitral valve repair. During 2‐year follow‐up, 8.2% (15/182) of patients with low, 21.3% (64/300) with intermediate, and 26.3% (52/198) with high MIDA score died (log‐rank test P

Background Effective orifice area (EOA) ≥0.2 cm 2 or regurgitant volume (Rvol) ≥30 mL predicts prognostic significance in functional mitral regurgitation (FMR). Both volumetric and proximal isovelocity surface area (PISA) methods enable calculation of these metrics. To determine their clinical value, we compared EOA and Rvol derived by volumetric and PISA quantitation upon outcome of patients with FMR. Methods and Results We examined the outcome of patients with left ventricular ejection fraction 2 ), Rvol (24.7 versus 16.9 mL), and regurgitant fraction (61 versus 37 %) respectively (all P value 2 or Rvol ≥30 mL had a worse outcome than those with EOA 2 or Rvol P =0.003 and 0.004) but not PISA quantitation (log rank P =0.984 and 0.544), respectively. Conclusions Volumetric and PISA methods yield different measurements of EOA and Rvol in FMR; volumetric values exhibit greater prognostic significance. The echo method of quantifying FMR may affect the management of this disorder.

BACKGROUND Very few data exist on percutaneous mitral valve repair (PMVr) in unstable patients with concomitant moderate-severe mitral regurgitation (MR). The purpose of this systematic review was to evaluate baseline characteristics, management and clinical outcomes of critically ill patients undergoing PMVr with MitraClip. METHODS We conducted a systematic review of the published data on MitraClip from its first use in 2003 to December 2020. Studies referring to critically ill patients in cardiogenic shock or acute refractory pulmonary edema were included. A total of 40 publications including 254 patients with significant MR (Grade 4 in 91%) were included. RESULTS Mean age was 70 ± 12 years with mean Euroscore II and STS of 21 ± 13 and 20.5 ± 16, respectively. Clinical presentation was with cardiogenic shock and acute myocardial infarction in 72.8 and 60.0% of patients, respectively. Device success was achieved in 238 (93.7%) patients with a significant reduction in MR (Grade ≤ 2 in 91.8%, p

Objectives We present our initial experience with the fourth-generation MitraClip™ (G4) system and propose preliminary criteria for device selection. Background The MitraClip™ G4 system recently underwent a "controlled release" for transcatheter edge-to-edge mitral valve repair. The four new devices include technical improvements such as controlled gripper actuation (independent leaflet capture) and continuous left atrial pressure monitoring. To date, a patient-specific device selection algorithm, and the technology's impact on procedural times and success, have not been described. Methods We present an initial multi-center experience and short-term outcomes with the new system, suggest procedural and imaging considerations, and propose initial guidance for device selection. Results Sixty-one procedures performed by three operators at two centers between November 2019 and May 2020 were analyzed. At 30-day follow-up, there were three deaths (4.9%), four neurological events (6.6%), and seven re-hospitalizations (11.5%). Fifty-nine patients achieved device and procedural success (96.7%), and there was one device-related technical issue (1.6%). Compared to the same operators utilizing the third generation MitraClip™, the G4 system resulted in a significant reduction in the median number of clips used per patient (1 IQR 1-2 vs. 2 IQR 1-3, p = .023) and a trend toward shorter device times. Conclusion Based on our initial experience, we found that the MitraClip™ G4 system is associated with high procedural success and fewer devices needed per procedure. The expanded device options may allow a more targeted approach to the myriad of pathologic presentations of mitral regurgitation. This early experience should provide a foundational opportunity for further refinement.

Aims Severe mitral regurgitation (MR) following acute myocardial infarction (MI) is associated with high mortality rates and has inconclusive recommendations in clinical guidelines. We aimed to report the international experience of patients with secondary MR following acute MI and compare the outcomes of those treated conservatively, surgically, and percutaneously. Methods and results Retrospective international registry of consecutive patients with at least moderate-to-severe MR following MI treated in 21 centres in North America, Europe, and the Middle East. The registry included patients treated conservatively and those having surgical mitral valve repair or replacement (SMVR) or percutaneous mitral valve repair (PMVR) using edge-to-edge repair. The primary endpoint was in-hospital mortality. A total of 471 patients were included (43% female, age 73 ± 11 years): 205 underwent interventions, of whom 106 were SMVR and 99 PMVR. Patients who underwent mitral valve intervention were in a worse clinical state (Killip class ≥3 in 60% vs. 43%, P < 0.01), but yet had lower in-hospital and 1-year mortality compared with those treated conservatively [11% vs. 27%, P < 0.01 and 16% vs. 35%, P < 0.01; adjusted hazard ratio (HR) 0.28, 95% confidence interval (CI) 0.18–0.46, P < 0.01]. Surgical mitral valve repair or replacement was performed earlier than PMVR [median of 12 days from MI date (interquartile range 5–19) vs. 19 days (10–40), P < 0.01]. The immediate procedural success did not differ between SMVR and PMVR (92% vs. 93%, P = 0.53). However, in-hospital and 1-year mortality rates were significantly higher in SMVR than in PMVR (16% vs. 6%, P = 0.03 and 31% vs. 17%, P = 0.04; adjusted HR 3.75, 95% CI 1.55–9.07, P < 0.01). Conclusions Early intervention may mitigate the poor prognosis associated with conservative therapy in patients with post-MI MR. Percutaneous mitral valve repair can serve as an alternative for surgery in reducing MR for high-risk patients.

Secondary mitral regurgitation (MR) occurs despite structurally normal valve apparatus due to an underlying disease of the myocardium leading to disruption of the balance between tethering and closing forces with ensuing failure of leaflet coaptation. In patients with heart failure (HF) and left ventricular dysfunction, secondary MR is independently associated with poor outcome, yet prognostic benefits related to the correction of MR have remained elusive. Surgery is not recommended for the correction of secondary MR outside coronary artery bypass grafting. Percutaneous mitral valve repair (PMVR) with MitraClip implantation has recently evolved as a new transcatheter treatment option of inoperable or high-risk patients with severe MR, with promising results supporting the extension of guideline recommendations. MitraClip is highly effective in reducing secondary MR in HF patients. However, the derived clinical benefit is still controversial as two randomized trials directly comparing PMVR vs. optimal medical therapy in severe secondary MR yielded virtually opposite conclusions. We reviewed current evidence to identify predictors of PMVR-related outcomes in secondary MR useful to improve the timing and the selection of patients who would derive maximal benefit from MitraClip intervention. Beyond mitral valve anatomy, optimal candidate selection should rely on a comprehensive diagnostic workup and a fine-tuned risk stratification process aimed at (i) recognizing the substantial heterogeneity of secondary MR and its complex interaction with the myocardium, (ii) foreseeing hemodynamic consequences of PMVR, (iii) anticipating futility and (iv) improving symptoms, quality of life and overall survival.

There is a worldwide expansion in percutaneous therapy for valvular heart disease. Rapidly evolving technology and the general increase in life expectancy will support the evolution of new treatment options dedicated to structural heart interventions. Transcatheter aortic valve implantation for severe aortic valve stenosis and percutaneous mitral valve repair with the MitraClip system for severe mitral regurgitation have been demonstrated as a feasible, innovative alternative for surgical treatment. Despite the inequality in clinical experience, both procedures have encouraging results and now are a part of everyday clinical practice. More importantly, rapid development is expected in the next decades. However, the global coronavirus disease 2019 (COVID-19) pandemic imposed redistribution of healthcare resources. Hospitals were obliged to modify their workflow and limit TAVI and MitraClip procedures to urgent or in highly symptomatic patients. Despite this encumbrance improvement in technology and experience supported by robust evidence from current studies might extend indications for both procedures. The future holds promise for this treatment modality to become the preferred procedure for all patients despite age or risk and reserving surgical treatment for a minority. Thus, we present state-of-the-art and current evidence for both methods assumed to change the paradigm of treatment of valvular heart failure in the future.

The prevalence of heart failure (HF) continues to rise over time, with aging of the population and increased survival of incident cases. Major improvements occurred in drug therapy but morbidity and mortality of HF patients remain high. Some non-pharmacologic approaches to HF are already part of standard treatment for HF, including implantable cardioverter-defibrillators, cardiac resynchronization therapy (CRT) and left ventricular assist devices (LVADs). A number of transcatheter treatments and devices have been developed to improve management of valvular heart diseases (VHD), and some of them are being used or tested in specific HF conditions. For example, transcatheter aortic valve implantation (TAVI) to unload the left ventricle in patients with moderate aortic stenosis (AS) and HF or TAVI for severe aortic regurgitation (AR) in patients with LVADs. Similarly, percutaneous mitral valve repair can be used to improve prognosis and quality of life in patients with functional mitral valve regurgitation, and has been proposed as a bridge-to-LVAD or to heart transplant in selected patients. Other devices have been specifically developed for the treatment of chronic HF. In this review we describe the main devices used in the treatment of HF associated with aortic and mitral valve disease, as well as novel transcatheter interventions for chronic HF with different pathophysiologic targets.

Objectives The aim of this study was to evaluate the impact of edge-to-edge PMVR on short and mid-term clinical outcomes in patients with CS and severe MR.Background Severe mitral regurgitation (MR) in the setting of cardiogenic shock (CS) is associated with three times higher risk of 1-year mortality. In refractory CS, edge-to-edge percutaneous mitral valve repair (PMVR) can be a potential therapeutic option.Methods We retrospectively included consecutive patients with refractory CS and concomitant severe MR treated with MitraClip (R) system. CS was defined according to the criteria used in the SHOCK trial and procedural success according to Mitral Valve Academic Research Consortium (MVARC) criteria. The 30-day and 6-month mortality were the primary and secondary endpoints respectively.Results Thirty-one patients (median age 73 years [interquartile range, IQR 66-78], 25.8% female), STS mortality score 37.9 [IQR 30.4-42.4]), with CS and concomitant severe MR treated with edge-to-edge PMVR were retrospectively enrolled. Procedural success was 87.1%. Thirty-day and 6-month survival rates were 78.4 and 45.2% respectively. Univariate Cox Regression Model analysis showed that procedural success was a predictor of both 30-day (HR = 0.12, 95% CI 0.03-0.55, p < .01) and 6-month survival (HR = 0.22, 95% CI 0.06-0.84, p = .027).Conclusions Edge-to-edge PMVR in patients with CS and concomitant severe MR was associated with good procedural safety and success with acceptable short and mid-term survival rates. It could be considered a bailout option in this setting of patients.

The MitraClip® (Abbott Vascular, Santa Clara, California) is a transcatheter mitral valve repair device that is used to treat mitral regurgitation of both degenerative and functinoal etiologies in select patients. Since its CE Mark approval in 2008 and initial United States FDA approval in 2013, implantation volume has increased dramatically and MitraClip therapy has become an established treatment option for select patients with MR. Cardiac anesthesiologists are likely to be called upon to care for these high-risk patients with increasing frequency. In this chapter, we provide an overview of the MitraClip procedure for the anesthesiologist. We begin by presenting background information, including the indications for implantation and the transcatheter device components. Following this, we describe the anesthetic management for the procedure and provide a stepwise review of the implantation process. Finally, we conclude by discussing potential intraprocedural complications.

Scientific reports 11(1), 12700 (2021). doi:10.1038/s41598-021-92255-3, Published by Macmillan Publishers Limited, part of Springer Nature, [London]

Aims: In patients with heart failure and reduced ejection fraction (HFrEF) and secondary mitral regurgitation (SMR), impaired right ventricular function (RVF) may negatively influence the prognosis. Percutaneous mitral valve repair (pMVR) can promote the recovery of RVF. We sought to characterize the response of the right ventricle to pMVR in HFrEF with SMR and to assess the association between improved RVF after pMVR and outcomes. Methods and results: Overall, 221 patients with HFrEF and SMR ≥3+ successfully treated with pMVR in four tertiary care centres for heart failure were included. Improved RVF was defined as Δ right ventricular fractional area change (ΔRVFAC) ≥5% at early follow-up (median time 4 months). The primary endpoint was a composite of death/heart transplantation (D/HT). Mean age was 69 ± 11 years, mean left ventricular ejection fraction was 31 ± 8% and mean RVFAC was 34 ± 9%. ΔRVFAC ≥5% occurred in 88 patients (40%) and was independent of the measures of left ventricular reverse remodelling. During a median follow-up of 29 months (interquartile range 12–46), 81 patients (37%) reached the primary endpoint. After adjustment for other significant covariates, ΔRVFAC ≥5% was significantly associated with lower risk of D/HT (hazard ratio 0.52, 95% confidence interval 0.29–0.94, P = 0.030). In the secondary outcome analysis exploring the risk of heart failure hospitalizations, ΔRVFAC ≥5% confirmed the prognostic association with the endpoint. Conclusions: In patients with HFrEF and SMR, about 40% of patients improved RVF after pMVR. RVF improvement was associated with better long-term survival free from HT and lower risk of heart failure hospitalization.

We aimed to identify predictors of mitral regurgitation recurrence (MR) after percutaneous mitral valve repair (PMVR) in patients with functional mitral regurgitation (FMR). Patients with FMR were enrolled who underwent PMVR using the MitraClip® device. Procedural success was defined as reduction of MR of at least one grade to MR grade ≤ 2 + assessed at discharge. Recurrence of MR was defined as MR grade 3 + or worse at one year after initially successful PMVR. A total of 306 patients with FMR underwent PMVR procedure. In 279 out of 306 patients (91.2%), PMVR was successfully performed with MR grade ≤ 2 + at discharge. In 11.4% of these patients, MR recurrence of initial successful PMVR after 1 year was observed. Recurrence of MR was associated with a higher rate of heart failure rehospitalization during the 12 months follow-up (52.0% vs. 30.3%; p = 0.029), and less improvement in New York Heart Association (NYHA) functional class [68% vs. 19% of the patients presenting with NYHA functional class III or IV one year after PMVR when compared to patients without recurrence (p = 0.001)]. Patients with MR recurrence were characterized by a higher left ventricular sphericity index {0.69 [Interquartile range (IQR) 0.64, 0.74] vs. 0.65 (IQR 0.58, 0.70), p = 0.003}, a larger left atrium volume [118 (IQR 96, 143) ml vs. 102 (IQR 84, 123) ml, p = 0.019], a larger tenting height 10 (IQR 9, 13) mm vs. 8 (IQR 7, 11) mm (p = 0.047), and a larger mitral valve annulus [41 (IQR 38, 43) mm vs. 39 (IQR 36, 40) mm, p = 0.015] when compared to patients with durable optimal long-term results. In a multivariate regression model, the left ventricular sphericity index [Odds Ratio (OR) 1.120, 95% Confidence Interval (CI) 1.039–1.413, p = 0.003)], tenting height (OR 1.207, 95% CI 1.031–1.413, p = 0.019), and left atrium enlargement (OR 1.018, 95% CI 1.000–1.038, p = 0.047) were predictors for MR recurrence after 1 year. In patients with FMR, baseline parameters of advanced heart failure such as spherical ventricle, tenting height and a large left atrium might indicate risk of recurrent MR one year after PMVR.

Objectives To assess outcomes in patients with acute mitral regurgitation (MR) following acute myocardial infarction (AMI) who received percutaneous mitral valve repair (PMVR) with the MitraClip device and to compare outcomes of patients who developed cardiogenic shock (CS) to those who did not (non-CS). Background Acute MR after AMI may lead to CS and is associated with high mortality. Methods This registry analyzed patients with MR after AMI who were treated with MitraClip at 18 centers within eight countries between January 2016 and February 2020. Patients were stratified into CS and non-CS groups. Primary outcomes were mortality and rehospitalization due to heart failure. Secondary outcomes were acute procedural success, functional improvement, and MR reduction. Multivariable Cox regression analysis evaluated association of CS with clinical outcomes. Results Among 93 patients analyzed (age 70.3 +/- 10.2 years), 50 patients (53.8%) experienced CS before PMVR. Mortality at 30 days (10% CS vs. 2.3% non-CS; p = .212) did not differ between groups. After median follow-up of 7 months (IQR 2.5-17 months), the combined event mortality/re-hospitalization was similar (28% CS vs. 25.6% non-CS; p = .793). Likewise, immediate procedural success (90% CS vs. 93% non-CS; p = .793) and need for reintervention (CS 6% vs. non-CS 2.3%, p = .621) or re-admission due to HF (CS 13% vs. NCS 23%, p = .253) at 3 months did not differ. CS was not independently associated with the combined end-point (hazard ratio 1.1; 95% CI, 0.3-4.6; p = .889). Conclusions Patients found to have significant MR during their index hospitalization for AMI had similar clinical outcomes with PMVR whether they presented in or out of cardiogenic shock, provided initial hemodynamic stabilization was first achieved before PMVR.

Right ventricular (RV) dysfunction and tricuspid regurgitation (TR) are known to be associated with adverse outcomes in patients undergoing percutaneous mitral valve repair (PMVR). Although the effect of PMVR on left ventricular function is well known, data on the response of the right ventricle to PMVR, and its impact on prognosis, are limited. In this review the authors summarize available data regarding the prognostic role of RV function and TR in PMVR recipients and the possible effects of PMVR on the right heart. Preprocedural tricuspid annular plane systolic excursion15 mm, tricuspid annular tissue Doppler S' velocity9.5 cm/sec, and moderate or severe TR are reported as predictors of adverse outcome after PMVR. Therefore, they should be carefully evaluated for patient selection. Moreover, emerging data show that the benefit of PMVR may go beyond the left heart, leading to an improvement in RV function and a reduction in TR severity. Among PMVR recipients, improvement in RV function and reduction of TR degree are observed mainly in patients with RV dysfunction at baseline. On the other hand, high postprocedural transmitral pressure gradients seem to be associated with lack of RV reverse remodeling. Timing of mitral intervention with respect to RV impairment and predictors of RV reverse remodeling after PMVR are unknown. Further studies are needed to fill these gaps in evidence.

Patients with severe mitral regurgitation (MR) after myocardial infarction (MI) have an increased risk of mortality. Transcatheter mitral valve repair may therefore be a suitable therapy. However, data on clinical outcomes of patients in an acute setting are scarce, especially those with reduced left ventricle (LV) dysfunction. We conducted a multinational, collaborative data analysis from 21 centers for patients who were, within 90 days of acute MI, treated with MitraClip due to severe MR. The cohort was divided according to median left ventricle ejection fraction (LVEF)—35%. Included in the study were 105 patients. The mean age was 71 ± 10 years. Patients in the LVEF &lt, 35% group were younger but with comparable Euroscore II, multivessel coronary artery disease, prior MI and coronary artery bypass graft surgery. Procedure time was comparable and acute success rate was high in both groups (94% vs. 90%, p = 0.728). MR grade was significantly reduced in both groups along with an immediate reduction in left atrial V-wave, pulmonary artery pressure and improvement in New York Heart Association (NYHA) class. In-hospital and 1-year mortality rates were not significantly different between the two groups (11% vs. 7%, p = 0.51 and 19% vs. 12%, p = 0.49) and neither was the 3-month re-hospitalization rate. In conclusion, MitraClip intervention in patients with acute severe functional mitral regurgitation (FMR) due to a recent MI in an acute setting is safe and feasible. Even patients with severe LV dysfunction may benefit from transcatheter mitral valve intervention and should not be excluded.

Background Whether fluoroscopic-echocardiographic fusion imaging (FI) might offer added value for intraprocedural guidance during transcatheter edge-to-edge mitral valve repair is yet unknown, and few data exist regarding the safety and feasibility of this novel technology. Methods The aim of this single-center study was to test and validate a FI protocol for intraprocedural monitoring of transcatheter edge-to-edge mitral valve repair and assess its clinical usefulness. Eighty patients underwent MitraClip implantation using FI guidance (FI+) for either degenerative (35%) or functional (65%) mitral regurgitation and were compared with the last 80 patients before FI introduction, treated using conventional echocardiography and fluoroscopic monitoring (FI−). Results The number of patients treated for functional and degenerative mitral regurgitation was similar between the FI+ and FI− groups, as well as the number of devices implanted (1.51 ± 0.5 vs 1.58 ± 0.6, P = .46). The prevalence of complex mitral anatomy for percutaneous repair was high (32.5%, up to 39.2% in the hybrid arm). Fluoroscopy time was significantly lower in FI+ patients (37.3 ± 14.6 vs 48.3 ± 28.3 min, P = .003), but not kerma area product (91.5 ± 74.1 vs 108.8 ± 105.0 Gy · cm2, P = .23) or procedural time (92.2 ± 36.1 vs 103.1 ± 42.7 min, P = .086). After adjusting for confounding factors (MitraClip XT device and complex anatomy), FI reduced fluoroscopy time (coefficient = −10.4 min; 95% CI, −18.03 to −2.82; P = .007) and improved procedural success at the end of the procedure (odds ratio, 2.87; 95% CI, 1.00 to 8.24; P = .049) and discharge (odds ratio, 2.24; 95% CI, 1.04 to 4.80; P = .039). Rates of periprocedural complications were similar in both groups (8.9% vs 13.0%, P = .40). Conclusions The authors describe the systematic use of an FI protocol for intraprocedural guidance during transcatheter edge-to-edge mitral valve repair, demonstrating a reduction in fluoroscopy time and an improvement in procedural success in a population with a high prevalence of challenging mitral anatomy for percutaneous repair.

Funding Acknowledgements Type of funding sources: None. Background – Although percutaneous mitral valve repair is an attractive alternative treatment option for patients with severe mitral regurgitation (MR) at high surgical risk, residual MR is commonly observed after the procedure and little is known about its impact on outcomes after MitraClip therapy, expecially in patients with severe left ventricular (LV) impairment. Purpose – The aim of this prospective, observational study was to evaluate the impact of residual MR (MR ≤1+ vs. MR >1+) on long-term outcomes of mitral valve repair with the MitraClip System in high surgical risk patients presenting with moderate-to-severe or severe MR and with severe reduction of LV ejection fraction (EF). Methods – Patients enrolled in the prospective Getting Reduction of Mitral Insufficiency by Percutaneous Clip Implantation (GRASP) with functional MR and EF ≤30% who were eligible at almost five-year follow-up were included in the present analysis. The primary endpoint was death at 5-year follow-up. Also echocardiographic parameters at baseline and 5-year follow-up and rehospitalization rates were assessed. Results – A total of 139 patients were included: 92 (66.2%) with post-procedural residual MR ≤1+ and 47 (33.8%) with residual MR > 1+ (41 patients with residual MR 2+, 5 with residual MR 3+, 1 with residual MR 4+). Comparable clinical and echocardiographic baseline characteristics were observed between the two groups except for NYHA functional class IV and implanted pace-maker (more frequent in patients with residual MR >1+) and previous myocardial infarction (more frequent in patients with residual MR ≤1+). At 5-year follow-up, no significant differences were reported in the primary endpoint (49.6% in patients with residual MR ≤ 1+ vs. 65.3% in patients with residual MR > 1+, p 0.203) and in cardiac death (37.8% in patients with residual MR ≤ 1+ vs. 42.6% in patients with residual MR > 1+, p 0.921). Cox regression analysis identified residual MR > 1+ as an independent predictor of re-hospitalization (HR 0.51, 95% CI 0.28-0.92, p =0.026). At 5-year follow-up, a significant reduction in left ventricular end-systolic volume was observed in patients with residual MR ≤ 1+. Conclusions – At 5-year follow no significant differences in survival emerged in patients with severe LV dysfunction undergoing MitraClip therapy regardless residual MR. Nevertheless residual MR > 1+ emerged as an indipendent predictor of re-hospitalization.

Background Percutaneous mitral valve repair (PMVR) is a therapeutic option for severe mitral regurgitation (MR) in patients with heart failure due to differential aetiologies. However, only little is known about the safety and efficacy of this procedure in patients with amyloid cardiomyopathy. Methods Five patients with cardiac amyloidosis and moderate to severe or severe MR undergoing PMVR were analysed retrospectively and compared to seven patients with cardiac amyloidosis and severe MR without intervention. Clinical and functional data, renal function and cardiac biomarkers as well as established risk scores for cardiac amyloidosis were assessed. Primary endpoint was the reduction in MR one year after PMVR. Secondary endpoints were safety, overall mortality after 12 months compared with the control group, as well as changes in clinical and functional parameters. Results Amyloidosis risk assessment documented amyloid cardiomyopathy at an advanced stage in all patients. Procedural, technical and device success of PMVR were all 100% and residual MR remained mild to moderate at 12 months follow-up (P = .038 vs before PMVR). Differences in survival compared with the control (no PMVR) group pointed to a possible survival benefit in the PMVR group (P = .02). Conclusion PMVR is a feasible and safe procedure in patients with cardiac amyloidosis and might carry a possible survival benefit in this patient group.

Background and aim: Recent randomized data comparing percutaneous mitral valve repair (PMVR) versus optimal medical treatment in patients with functional MR (FMR) seemed to highlight the importance of the learning curve not only for procedural outcomes but also for patient selection. The aim of the study was to compare a contemporary series of patients undergoing PMVR using a second-generation Mitraclip device (Mitraclip NT) with previous cohorts treated with a first-generation system. Methods: This multicenter study collected individual data from 18 centers between 2012 and 2017. The cohort was divided into three groups according to the use of the first-generation Mitraclip during the first (control-1) or second half (control-2) or the Mitraclip NT system. Results: A total of 545 consecutive patients were included in the study. Among all, 182 (33.3%), 183 (33.3%), and 180 (33.3%) patients underwent mitral repair in the control-1, control-2, and NT cohorts, respectively. Procedural success was achieved in 93.3% of patients without differences between groups. Major adverse events did not statistically differ among groups, but there was a higher rate of pericardial effusion in the control-1 group (4.3%, 0.6%, and 2.6%, respectively, p = 0.025). The composite endpoint of death, surgery, and admission for congestive heart failure (CHF) at 12 months was lower in the NT group (23.5% in control-1, 22.5% in control-2, and 8.3% in the NT group, p = 0.032). Conclusions: The present paper shows that contemporary clinical outcomes of patients undergoing PMVR with the Mitraclip system have improved over time.

Background: In the last year, percutaneous mitral valve repair (PMVR) using the MitraClip system (Evalve Inc., Menlo Park, California) has established itself as a proven treatment option for patients with inoperable mitral regurgitation (MR). However, reduction of MR usually comes at the expense of forward flow and mean mitral gradients (MMG). Finding the ideal balance of reduction of MR grade and acceptable MMG carries significant clinical implications. The purpose of this study was to compare short-term outcomes in patients with less than moderate MR but elevated MMG to patients with at least moderate MR. Methods: This was a retrospective, observational study from 2014-2019 of 128 patients who underwent PMVR at our institution. Patients were separated into cohorts depending on their post-PMVR MR grade and MMG. Cohort 1 included patients with the best possible result post-PMVR, less than moderate MR and a MMG 5mmHg post-PMVR. Cohort 3 included patients with at least moderate MR post-PMVR. Our primary outcome of interest was a composite of inpatient death and 30-day readmission. Results: Cohort 1 included 30 patients who had less than moderate MR and a MMG 5mmHg. Cohort 3 included 65 patients who had more than moderate MR post-PMVR. We found that our primary composite endpoint occurred more frequently in patients who had at least moderate residual MR (cohort 3) (9.1% vs. 27.7%, p=0.0438). Patients with less than moderate MR post-PMVR despite a MMG >5mmHg were 3.8 times less likely to have inpatient death or a 30-day readmission when compared to patients with at least moderate MR post-PMVR (CI 0.071, 0.963). Conclusions: Our study suggests that achieving a goal of less than moderate MR despite modest increases in MMG can result in better short-term outcomes (inpatient death + 30-day readmission) when compared to patients who are left with at least moderate MR post-PMVR.

Background Percutaneous mitral valve repairs has been increasingly performed worldwide. The MITRA-UMG registry provides a snapshot of a real-world clinical data and outcomes. Purpose We sought to investigate predictors of clinical outcomes in patients with mitral regurgitation undergoing percutaneous valve repair. Methods The MITRA-UMG registry retrospectively collected data from consecutive patients with symptomatic moderate-to-severe or severe MR underwent MitraClip implantation. The primary endpoint of interest was the composite of cardiovascular death or rehospitalization for HF. Results Between March 2012 and July 2018, a total of 133 consecutive patients admitted to our institution were included. Acute procedural success was obtained in 95.4% of patients, with no intraprocedural death. The composite primary endpoint of cardiovascular death or rehospitalization for heart failure was met in 50 patients (38%) with cumulative incidences of 7%, 25%, at 30 days and 1 year, respectively. In the Cox multivariate model, NYHA functional class IV, left ventricular end-diastolic volume index (LVEDVi), Euroscore II, independently increased the risk of the primary endpoint at long-term follow-up. At Kaplan-Meier analysis, a LVEDVi >92 ml/m2 was associated with an increased incidence of the primary endpoint. Conclusions In searching the ideal phenotype of patients who benefit most of percutaneous mitral valve repair, those presenting with severely dilated ventricles (LVEDVi >92 ml/m2), high operative risk (EUROSCORE II >7%) or advanced heart failure symptoms (NYHA IV) at baseline carried the worst prognosis at long-term. Funding Acknowledgement Type of funding source: None

Background/Introduction Cardiogenic shock (CS) is a medical emergency and a frequent cause of death. CS can be complicated by mitral regurgitation (MR). The presence of at least moderate MR in the setting of shock was associated with about three-times higher odds of 1-year mortality. In the setting of refractory CS, percutaneous mitral valve repair (PMVR) can be a potential therapeutic option. Purpose The aim of the study was to evaluate the efficacy of percutaneous approach of severe MR in patients with CS assessing short-term clinical outcomes. Methods In this study we retrospectively included patients with CS and concomitant severe MR treated with Mitraclip system. We enrolled 28 patients from 5 Italian centers between 2012 and 2019. MitraClip implantation was performed according to each hospital standard care. CS was defined utilizing the Diagnostic Criteria of Cardiogenic Shock used in the SHOCK trial. Procedural success was defined as the presence of moderate or less MR after MitraClip implantation. Results All patients presented at least severe MR. All treated patients were at high surgical risk (STS mortality score 36.4±11.7%). Procedural success was obtained in 24 patients (86%). A mean of 1.71±0.76 clips per patients were implanted. In-hospital complications occurred in 13 patients (46%): 7 minor bleedings (25% of patients), 7 major bleedings (25%), 8 acute kidney injuries (28%). In-hospital mortality was 25% and the reported causes of death were cardiovascular in all patients. At Cox multivariate analysis procedural success was a strong predictor of in-hospital survival (HR 0.11, CI 95% 0.02–0.67, p=0.017). Conclusions PMVR with Mitraclip system in patients with CS and concomitant MR demonstrated high procedural success and acceptable safety. It can be considered a bailout option in this setting of patients with high short-term mortality. Larger prospective studies are needed. In-hospital mortality predictors Funding Acknowledgement Type of funding source: None

Background Tricuspid Regurgitation (TR) is often present in patients with mitral regurgitation (MR) and is associated with increased mortality and morbidity after percutaneous mitral valve repair (PMVR) using the MitraClip (Abbott Vascular). It is unclear to what extent TR is reduced after PMVR and whether the reduction of TR is related to survival and functional outcome. Purpose The aim of this study was to determine (1) the TR course after PMVR and (2) if this was related to survival and clinical outcome. Methods Patients who underwent PMVR and had complete echocardiographic data at baseline and follow-up were included. TR severity was graded as none, mild, moderate or severe (according to current guidelines) and was determined before treatment and at 6-months of follow up. Favorable TR course was defined as improvement of ≥1 grade or ≤ mild TR at 6-months. Clinical endpoints were all-cause mortality during 1-year of follow-up and improvement in New York Heart Association (NYHA) functional class after 6 months. Results A total of 67 patients were included (mean age 76 years, 57% male, 81% NYHA class ≥3 and 69% baseline TR ≥ moderate). Favorable TR course was achieved in 31 patients (46%) (figure 1A). All-cause mortality at 1 year was 7.5%, and was lower in the favorable TR course group (0% vs. 13.9%, p=0.057) (figure 1B). Improvement in NYHA class at 6-months was seen in 45% of patients without vs. 81% of patients with favorable TR course (p=0.01) (figure 1C). Conclusion A favorable TR course is achieved in 46% of PMVR patients and is associated with improved survival and improvement of NYHA class. The relatively high rate of an unfavorable TR course at 6-months, indicates that interventional treatment of the tricuspid valve might benefit these patients. TR course (A) and NYHA improvement (B) Funding Acknowledgement Type of funding source: Other. Main funding source(s): Abbott