MitraClip Repair Research Articles

P4727Comparing in-hospital outcomes of transcatheter mitral valve repair vs surgical mitral valve repair in patients with pulmonary hypertension

Abstract Background The comparative outcomes of transcatheter mitral valve repair with Mitraclip (TMVR) versus surgical mitral valve repair (SMVR) in pulmonary hypertension (PH) patients are underexplored. Methods The Nationwide Inpatient Sample (NIS) database was queried from 2009 to 2015 and those who underwent TMVR or SMVR with PH were identified. International Classification of Diseases (ICD) codes were used to identify the target population, primary and secondary outcomes. Propensity scores (PS) were calculated for each patient. A standardized morbidity ratio (SMR) weight was then calculated for each patient in both groups. Absolute standardized differences (ASD) were used to compare the baseline characteristics. Results We identified a total of 341 and 4,665 cases from NIS who underwent TMVR and SMVR, respectively, over the study period. The mean age of patients was 67 yrs. Patients who underwent TMVR were older (75 vs. 66, ASD =0.32). Women comprised 47.8% of TMVR admission while 42.16% of SMVR admissions were females. Patients who underwent TMVR had a significantly higher Elixhauser comorbidity score >4 (43.4% vs 34.2%, ASD =0.3). TMVR group had higher rates of previous myocardial infarctions (16.7% vs. 7.1%, ASD = 0.30), congestive heart failure (80% vs. 6.2%, ASD = 0.44), percutaneous intervention (PCI) (15.6% vs. 5.9%, ASD = 0.32), coronary artery bypass grafting (CABG) (22.8% vs. 2.7%, ASD = 0.63), cerebrovascular disease (13.5% vs. 5.5%, ASD = 0.27), chronic obstructive pulmonary disease (30.8% vs. 21.1%, ASD = 0.22)and chronic renal failure (43.1% vs. 18.9%, ASD = 0.54). Inpatient mortality was similar between the 2 groups (3.6% vs 6.2%, p=0.573). TMVR patients had less hemorrhage requiring transfusion (8.1% vs 21.1, p<0.001), acute kidney injury (22.2% vs 33.6%, p<0.001), pacemaker placement (1.20% vs 6.89%, p<0.001), cardiogenic shock (4.5% vs 11.5%, p=0.0012) and mechanical circulatory device need (3.9% vs 9.7%, p=0.003). The TMVR group had lower median hospital cost ($53,824 vs $68,311, p<0.001) and LOS (7.5 days vs 13.1 days, p<0.001). Conclusions While in-hospital mortality in PH patients after TMVR compared to SMVR, TMVR was associated with significantly lower periprocedural complications.

Usefulness of Age (≥85 Years) and Residual Mitral Regurgitation (>1+/4+) for the Prediction of Adverse Outcomes in Patients Receiving the MitraClip

The goal of this study was to determine the predictors of adverse clinical outcomes in patients treated with the MitraClip for significant mitral regurgitation (MR) with a focus on acute changes in hemodynamics and cardiac function. This retrospective study included 63 patients (mean age 82 ± 8 years, 48% male) with moderate to severe or severe MR. Cardiac catheterization was performed before and immediately after MitraClip repair. Volumetric and functional changes were assessed in both ventricles. A major adverse cardiac event was defined as a composite of cardiac death and readmission for heart failure. Patients were followed up on average for 380 days. MR was improved in 92% of patients after MitraClip therapy from an average grade of 4+ to <2+ (p <0.001). The pulmonary capillary wedge pressure decreased from 22 ± 7 mm Hg to 19 ± 6 mm Hg (p <0.001), and the cardiac stroke volume increased by 28% from 102 ± 53 ml to 131 ± 54 ml (p <0.001). The left ventricular end-diastolic volume was significantly reduced 24 hours after MitraClip therapy compared to that at baseline (p = 0.001). In the multivariate Cox proportion hazard regression model, an age ≥85 years (p <0.001) and residual MR >1+ (p <0.048) were predictors of an adverse prognosis at follow-up. In conclusion, a reduced left ventricular end-diastolic volume and improved hemodynamics occurred early after MitraClip therapy. An advanced age (≥85 years) and residual MR >1+ were associated with an increased risk of mortality and heart failure.

Iatrogenic atrial septal defect closure after transseptal mitral valve interventions: Indications and outcomes.

Review indications and outcomes for transcatheter iatrogenic atrial septal defect (iASD) closure in patients undergoing MitraClip or transseptal (TS) mitral valve-in-valve/ring (ViV/ViR) procedures. Mitral valve transcatheter interventions require large-diameter TS sheaths that can result in iASDs that necessitate post-procedure transcatheter closure. Although the presence of iASD has been well-described, indications for closure and outcomes after TS mitral valve interventions have not been reported. Patients undergoing MitraClip repair and ViV or ViR transcatheter mitral valve replacement (TMVR) from February 14, 2014, to January 16, 2018, were studied retrospectively in this single center study. Seventeen patients had iASD closure: 11 MitraClip and 6 TMVR (5 ViV, 1 ViR). Indications for iASD closure included large iASD (n = 7), large left-to-right shunt (n = 9), pulmonary hypertension (n = 8), large right-to-left shunt (n = 1), severe RV dysfunction (n = 2), thin/aneurysmal septum (n = 2), and mobile material on pacemaker leads (n = 2). Closures were performed without complications using Amplatzer septal occluders. At 30 days, 94% of subjects (n = 16) were alive with one patient deceased from unknown causes. There were no myocardial infarctions or strokes. At 12 months, follow-up was available for 14 of 17 patients, and 71% of patients (10/14) were alive. One patient died due to cardiac causes, two from noncardiac causes and one for unknown reasons. There was one myocardial infarction, one intraparenchymal hemorrhage, and no ischemic strokes. The most common reasons for iASD closure after TS MV procedures are: large ASD unlikely to spontaneously close, large left-to-right shunt, and pulmonary hypertension. Patients who required iASD closure had low 30-day mortality but higher one-year mortality potentially reflecting a population with substantial comorbidities.

Clinical outcomes of percutaneous mitral valve repair with MitraClip for the management of functional mitral regurgitation.

To evaluate the safety and efficacy of percutaneous mitral valve repair for the management of functional mitral insufficiency. Severe FMR is present in 25-30% of patients with heart failure and is an independent predictor of mortality and hospitalizations in patients with both ischemic and nonischemic cardiomyopathy. MitraClip therapy has been approved for high surgical risk patients with primary mitral regurgitation. Recent studies including two randomized trials have yielded conflicting results in terms of its clinical efficacy and outcomes for FMR. A quantitative evaluation and synthesis of this information are essential in elucidating the role of MitraClip repair for FMR. We performed a literature search using PubMed, EMBASE, and Cochrane Central Register of Controlled Trials from September 2008 to September 2018. Studies comparing percutaneous mitral valve repair using the MitraClip device against conservative therapy for the management of functional mitral regurgitation were included. Seven studies with 1,174 patients in MitraClip group and 1,015 patients in medical therapy group met inclusion criteria. The 12-month mortality in the MitraClip group was 18.4% compared with 25.9% in the medical therapy group (odds ratio [OR]: 0.65 [0.50, 0.86]; p < .002). The rate of readmission at 12 months was 29.9% in the MitraClip group compared with 54.1% in the medical therapy group (OR: 040 [0.32-0.49]; p < .0001. The prognostic efficacy of MitraClip repair appears to be more substantial over longer follow-up period over medical therapy alone. Based on the results of this meta-analysis, percutaneous mitral valve repair with MitraClip appears to be superior to medical therapy for symptomatic moderate-to-severe functional mitral insufficiency. Further clinical research is needed to identify the ideal patient subgroups who receive maximum benefit with the MitraClip therapy.

Mid-term outcomes (up to 5 years) of percutaneous edge-to-edge mitral repair in the real-world according to regurgitation mechanism: A single-center experience.

To report mid-term results after MitraClip repair, according to mitral regurgitation (MR) mechanism, in a real-world single-center experience. Mid-term outcomes of percutaneous edge-to-edge mitral repair in the real world are still limited. We assessed the follow-up results of patients treated with MitraClip at a single high-volume mitral center from 2008 to 2016. All patients underwent Heart-Team discussion, prospective data collection and enrolment in a dedicated outpatient clinic. Functional (FMR, n = 242, 68.6%) and degenerative (DMR, n = 97, 27.5%) MR patients were separately analyzed. 5-Year survival was 53.5 ± 4.5% in FMR vs 57.1 ± 7.5% in DMR (P = 0.087). Reduced survival was strongly associated with worse left ventricle remodeling (ESV HR 1.01, CI 1.01-1.02, P < 0.001) in FMR, and with worse symptoms (New York Heart Association IV HR 6.72, CI 1.78-25.45, P = 0.005) in DMR. 5-Year cumulative incidence function for MR ≥ 3 was 23.7 ± 3.4% in FMR vs 27.9 ± 5.9% in DMR (P = 0.39), being associated with residual MR = 2 both in FMR (HR 4.67, CI 2.49-8.74, P < 0.001) and DMR (HR 7.15, CI 2.72-18.75, P < 0.001). At 5-year, patients in NYHA class I-II increased from 17.9% to 45.3% in FMR (P < 0.001) and from 33.3% to 51.3% in DMR (P < 0.001). In this single-center real-world experience, 5-year after MitraClip, half of the patients were alive and 3/4 were free from MR, both in FMR and DMR. Symptoms benefit was sustained in both groups. Advanced ventricular remodeling, advanced symptoms, and suboptimal MR reduction were associated with worse results. Refined patient selection, improved efficacy and more data will be all required to improve long-term outcomes.

Degenerative Mitral Regurgitation After Nonmitral Cardiac Surgery: MitraClip Versus Surgical Reconstruction

Surgical mitral valve repair is the conventional treatment for severe degenerative mitral regurgitation (MR). MitraClip therapy has emerged as a viable option in high-risk surgical patients. We sought to compare conventional surgery to MitraClip therapy in patients with severe degenerative mitral valve prolapse (MVP) and previous cardiac interventions. From January 2012 to May 2016, 131 patients with previous cardiac surgery and subsequent intervention for degenerative MVP were included in this analysis: 75 (57.3%) underwent surgical repair and 56 (42.7%) underwent MitraClip placement. Follow-up was available in all early survivors at median of 11 (interquartile range, 0 to 32) months for surgery and 11 (interquartile range, 3 to 21) months for MitraClip patients. MitraClip patients were older (75.7 ± 8.6 years of age versus 68.6 ± 13.1 of age; p < 0.001), and had higher Society of Thoracic Surgeons risk scores (5.8 ± 2.4 versus 2.7 ± 2.3; p < 0.001). Median length-of-stay was 7 (interquartile range, 5 to 11) days for surgery and 2 (interquartile range, 2 to 4) days for MitraClip patients (p < 0.001), but 30-day mortality was comparable between the 2 groups (2.7% versus 3.6%; p= 0.77). Recurrent MR (moderate or severe) was significantly higher for MitraClip patients, both at discharge (43.1% versus 5.4%; p < 0.001) and at 1-year follow-up (66.7% versus 33.3%; p= 0.02). At 1 year postintervention, freedom from mitral reintervention was significantly higher for surgical patients (100.0% versus 87.5%; p=0.006). In patients with previous cardiac interventions and severe degenerative MVP, a repeat conventional surgery is safe and durable. Percutaneous MitraClip repair is effective but associated with higher risk of residual MR, and should only be considered in selected patients. Careful patient selection using a heart team approach is recommended.

TCT-46 Mitral Valve Gradient, Heart Failure Admissions and One Year Mortality Following MitraClip Repair in 5,378 Patients: Results from the ACC/STS TVT Registry

The MitraClip device reduces mitral regurgitation (MR) and improves outcomes. With leaflet repair, the diastolic orifice is reduced and increased mitral valve gradients (MVG) can develop. Whether residual MVG affects outcomes was explored. MitraClip cases from 11/3/13-6/30/16 from the TVT Registry

Continuous invasive hemodynamic monitoring using steerable guide catheter to optimize mitraclip transcatheter mitral valve repair: A multicenter, proof-of-concept study.

We report our multicenter experience on continuous hemodynamic monitoring using exclusively the steerable guide catheter (SGC) during MitraClip repair. Left atrial pressure (LAP) and V-wave are useful to evaluate MitraClip repair but no simple method of continuous monitoring exists. From 11/2016 to 8/2017, 74 patients from four centers with symptomatic moderate-severe to severe mitral regurgitation (MR), underwent MitraClip NT repair with continuous hemodynamic monitoring via the SGC. Real-time LAP/V-wave changes were compared with transesophageal echocardiography (TEE). When mitral stenosis was suspected, transmitral gradients were verified by invasive hemodynamics. Clinical and echocardiographic outcomes were determined. Mean age was 78 ± 10 years and STS score 9.1 ± 11.0%. Pathology included leaflet prolapse/flail (45%), restriction (35%), and mixed (20%). Number of clips averaged 1.7 ± 0.7 per case. There was a significant reduction in LAP (21 ± 10 to 15 ± 7 mmHg, P < 0.0001) and V-wave(37 ± 19 to 24 ± 10 mmHg, P < 0.0001) post MitraClip, but the decrease was less in patients with atrial fibrillation (P < 0.05). Transmitral gradient significantly increased from 2.0 ± 1.2 to 4.0 ± 1.7 mmHg (P < 0.0001). Paradoxical increases in LAP and V-wave despite MR reduction were observed in three cases requiring MitraClip repositioning or retrieval to avoid stenosis. Follow-up averaged 5.0 ± 2.9 months and was 100% complete. KCCQ improvement was significant and MR reduction to <1+ was 67% and <2+ was 93% at 30 days. Continuous hemodynamic monitoring using the SGC complements TEE to assess and optimize MitraClip repair in real-time. Further validation is necessary but this feature may be part of future MitraClip and other transcatheter mitral repair systems.

CONTINUOUS LEFT ATRIAL PRESSURE AND INVASIVE HEMODYNAMIC MONITORING VIA STEERABLE GUIDE CATHETER TO OPTIMIZE TRANSCATHETER MITRAL VALVE REPAIR WITH MITRACLIP NT SYSTEM

Left atrial pressure (LAP) and V-wave reduction are markers of successful transcatheter mitral repair but no simple method of continuous monitoring exists. We report our multicenter experience on continuous LAP monitoring during MitraClip repair. From 11/2016 to 8/2017, 74 prohibitive risk patients

Is Surgical or Catheter-based Interventions an Option After an Unsuccessful Mitral Clip?

The objective of this study was to assess the results of catheter-based and surgical reinterventions in primary mitral regurgitation after failed MitraClip therapy. We report on 21 consecutive symptomatic patients with primary mitral regurgitation (median age 78 years) who underwent either repeat MitraClip therapy (n = 7) or mitral valve surgery (n = 14) after failure of the index procedure with 1-2 MitraClip implantations. At the time of reinterventions, 193 (interquartile range [IQR]: 32-622) days after the index procedure, patients had recurrent or persistent grade 3 mitral regurgitation. Early mortality at 30 days was 4.8%. Cardiac-related survival at 2 years was 85.4% (4 cardiac and 4 noncardiac deaths). Three of 7 patients with percutaneous reintervention were converted to surgery at 34, 52, and 56 days because repeat MitraClip therapy was ineffective because of pre-existing clip detachment or leaflet tear. Final therapy was biological mitral valve replacement in 14 of 21 patients (66.7%); 4 were treated with percutaneous repeat MitraClip repair (19%), and in 3 patients, surgical repairs were performed (14.3%). At follow-up with a median of 708 days, New York Heart Association class had improved significantly to class 2 (IQR: 1.0-2.5) (P = 0.0004), and the left ventricular end-diastolic diameter had decreased from 56 (IQR: 52-59) mm to 51 (48-58) mm (P = 0.0378), respectively. Recurrence of significant mitral regurgitation was absent in all but 1 patient with unsuccessful repeat MitraClip therapy who was deemed inoperable. Our data show that both repeat MitraClip and also mitral valve surgery are feasible and safe alternatives in patients without an excessively increased perioperative risk. We conclude that whenever leaflet insertion is not compromised, repeat catheter-based repair is a reasonable redo concept; in the remaining cases, surgery should be offered to the patient.

Percutaneous Treatment of Mitral Regurgitation: Present and Future

ABSTRACT Mitral valve regurgitation poses a significant public health burden, with more than 3 million people in the US alone suffering from moderate or severe mitral valve regurgitation. Surgical correction with mitral valve repair or replacement is the mainstay of therapy. However, a significant proportion of elderly patients are not eligible for mitral valve repair or replacement due to prohibitive surgical risk from increased age, poor ventricular function, or associated comorbidities. Percutaneous mitral valve repair/replacement techniques have been developed to fill this void. The most advanced percutaneous technique with the highest safety and efficacy to date is the edge-to-edge MitraClip repair system. The majority of other catheter-based mitral valve repair/replacement devices are at early developmental stages, but have shown encouraging initial results in feasibility trials. Transcatheter mitral valve replacement holds promise to emerge as the leading transcatheter treatment of choice in the fu...

Role of Echocardiography in Transcatheter Valvular Heart Disease Interventions.

Transcatheter valvular interventions have increased in importance and utility for surgical valve repair and replacement. Cardiac imaging is the most crucial aspect of procedural planning and guidance. Echocardiography is a widely used, portable, and dynamic imaging modality used for many of these interventions. This review will summarize the role echocardiography in structural heart valvular interventions. Intraprocedural echocardiographic guidance has been a mainstay of structural heart interventions. Over the years, the use of 3-dimensional echocardiography has increased, and studies have shown utility in paravalvular leak prediction in the setting of transcatheter aortic valve replacement, procedural guidance in MitraClip repair, and in mitral and tricuspid valve therapies. Intraprocedural echocardiography is of paramount important for procedural success during all structural heart valvular interventions. Continued use of 2 and 3-dimensional echocardiography will be a major factor in driving the innovative field of structural heart interventions forward.

Relation of Residual Mitral Regurgitation Despite Elevated Mitral Gradients to Risk of Heart Failure Hospitalization After MitraClip Repair

Achieving minimal residual mitral regurgitation (MR) after percutaneous MitraClip repair is limited by iatrogenic mitral stenosis. It is unknown whether allowing moderately elevated postprocedural mean mitral gradients (MMGs) to achieve < moderate residual MR is preferable to moderate residual regurgitation. Patients with less-than-moderate residual MR but a MMG of ≥5 mmHg (Group 1) were compared with patients with moderate residual MR (Group 2). The primary end point was heart failure hospitalization. Secondary end points included mortality, subsequent mitral valve surgery, and MR at 1 year. Seventy-eight patients were included in the study. Group 1 included 48 patients (median MMG 6, interquartile range 5-6 mmHg). Group 2 included 30 patients (median MMG 3.5, interquartile range 2-5 mmHg). Age, baseline MR severity, and type of MR were not different between groups. Freedom from heart failure hospitalization at 1 year was 91.2 ± 4.2% in Group 1 versus 70.8 ± 8.7% in Group 2 (p = 0.021). Achieved differences in MR reduction between groups persisted at 1 year (p = 0.007). Survival was not different (p = 0.402), and subsequent mitral valve surgery occurred in 4 of 48 (8%) and in 4 of 30 patients (13%) in Group 1 and Group 2, respectively (p = 0.476). By multivariate Cox regression analysis, less-than-moderate residual MR, despite moderately elevated mitral gradients, was associated with a hazard ratio of 0.21 (95% confidence interval 0.04 to 0.96) for subsequent heart failure hospitalization (p = 0.044). In conclusion, patients with less-than-moderate residual MR despite a MMG of ≥5 had a 79% reduction in hazard for subsequent heart failure hospitalization compared with patients with moderate residual MR.

Mitro-aortic pathology: apoint of view for afully transcatheter staged approach.

Severe aortic valve stenosis (AVS) and mitral valve regurgitation (MVR) often coexist. Although a fully percutaneous treatment for the two conditions, by means of transcatheter aortic valve implantation (TAVI) followed by MitraClip, can be appealing in selected high-risk candidates, critical and strategical reasoning should be applied. In a 3-year period we have developed a single-centre experience of 14 patients who were managed with a staged percutaneous approach to treat severe AVS and MVR. The average interval from TAVI to MitraClip repair was 101 ± 12 days. Success for TAVI was 100% and 92.9% (13/14) for MitraClip. At late follow-up, 3 patients developed MVR 3+. Estimated 1‑year survival was 66.5%. Freedom from 1‑year endpoint (death, stroke, major bleeding, myocardial infarction, and cardiac re-hospitalisation) was 57.9%.In our view, a fully transcatheter approach for mitro-aortic pathology is feasible and should be performed only as a staged procedure in those patients that remain symptomatic, in spite of successful TAVI. It should be emphasised that although the periprocedural success rate is satisfactory, follow-up mortality and re-hospitalisation rates remain high, even at mid-term follow-up. This most probably results from the advanced clinical picture at time of referral for treatment.

Italy: coronary and structural heart interventions from 2010 to 2015.

The aim of this report is to analyse trends in Italian cathlab activity between 2010 and 2015. Data were obtained from the national database of the Italian Society of Interventional Cardiology (GISE), which includes 97% of Italian cardiac catheterisation laboratories. The number of percutaneous coronary interventions (PCI) has remained relatively stable in the past five years. We have observed a significant increase in the number of primary PCI (pPCI) from 471.5 to 557.5 per million inhabitants with a consequent reduction of rescue primary PCI/fibrinolysis. One of the possible explanations for this might be the extensive networking for primary PCI and the adoption of Stent for Life initiatives in five regions. There has been a notably increased use of drug-eluting stents and, despite the fact that the introduction of bioabsorbable vascular scaffolds is recent, there is a slight, progressively positive trend. Invasive physiologic evaluation of coronary stenosis has markedly increased. Radial artery access has become the default option for PCI and for pPCI. In the last five years, TAVI procedures have doubled in number, while MitraClip and mitral repair procedures have shown a fivefold increase. Left atrial appendage (LAA) occlusion procedures have more than doubled in four years.

Percutaneous mitral valve repair: The MitraClip device.

Chronic mitral regurgitation (MR) is the most common cardiac valvular disease with more than 4 million people in the United States alone suffering from moderate or severe MR. Left untreated, chronic MR results in serious consequences. Surgical correction with mitral valve repair or replacement remains the mainstay of therapy for MR. Nevertheless, a large proportion of patients may not be offered treatment due to concerns over surgical risk. This unmet therapeutic need for a less invasive approach led to a marked explosion in the development of a variety of transcatheter approaches to treat mitral regurgitation in the past decade. The majority of these devices are based on principles learned from surgical mitral valve repair techniques. Inspired by the Alfieri surgical technique, the MitraClip edge-to-edge repair system is the most advanced technique with the highest safety and efficacy to date. In this review, we discuss the current status of the MitraClip repair system in the treatment of mitral regurgitation.

Mitral annular calcification is not associated with decreased procedural success, durability of repair, or left ventricular remodelling in percutaneous edge-to-edge repair of mitral regurgitation.

Mitral annular calcification (MAC) negatively influences outcomes in surgical mitral valve (MV) repair for mitral regurgitation (MR). However, there are no data on whether MAC impacts on outcomes of MitraClip percutaneous MV edge-to-edge repair. This study sought to investigate whether the presence of MAC impacts on the procedural success and durability of percutaneous transcatheter repair of MR using the MitraClip. One hundred and seventy-three patients undergoing MitraClip repair for significant MR were studied. Patients with moderate-or-severe MAC (n=28) were compared to those with no-or-mild MAC. Post-procedural MR severity was not different (p=0.642) and MR reduction to moderate-or-less was equally high in patients with moderate-or-severe MAC (100%) and those without (96.7%), p=1.000. At one year, MR severity was not different (p=0.831), and there was no difference in the repair durability when comparing patients with moderate-or-severe MAC (93.8%) to those without (90.6%), p=1.000. All patients with moderate-or-severe MAC assessed at one year were in NYHA functional Class I-II and had haemodynamic improvements with a decrease in pulmonary artery systolic pressure (-6.5±13.1 mmHg), p=0.021, and end-diastolic left ventricular internal diameter (-3.9±6.5 mm), p=0.034, not different to those achieved by patients without MAC (both p>0.100). Moderate-or-severe MAC scored by echocardiography and confirmed on fluoroscopy was not associated with decreased procedural success or durability of repair. Patients with moderate-or-severe MAC had improvements in clinical symptoms and haemodynamics, as well as decreased left ventricular dimensions.

Left atrial remodeling in patients undergoing percutaneous mitral valve repair with the MitraClip system: an advanced echocardiography study.

The goal of this study was to determine changes in left atrial (LA) function with two-dimensional speckle tracking echocardiography (2DSTE) and real-time full-volume three-dimensional echocardiography (RT3DE) after percutaneous mitral valve repair with the MitraClip system. Furthermore, we investigated whether baseline and/or changes in LA function after MitraClip repair had any impact on prognosis. A total of 25 consecutive patients (age: 57±12years, 76% male) with moderate-to-severe or severe mitral regurgitation (MR) were included. Patients underwent 2DSTE and RT3DE before the clip implantation and after the 12-month follow-up. Prognostic data were also recorded via the use of telephone calls and follow-up visits for 12months after the procedure. Compared with the baseline, the LA reservoir strain (LA-Res) (7.66±4.3% vs 11.15±7.5%, P<.001) and LA contraction strain (LA-Pump) (4.64±4.3% vs 7.63±5.8%, P=.001) improved significantly after MitraClip repair; significant improvements were also seen in three-dimensional (3D) minimum LA volume index (LAV min) and maximum LA volume index (LAV max). On the other hand, conventional LA indices did not change. In total, eleven major adverse cardiac events (MACE) were observed at the 1-year follow-up. In univariate analyses, the preprocedural echocardiographic parameters that were associated with the MACE within 1year after MitraClip repair were 3D-LAV min and LA-Res. Furthermore, these indices significantly correlated with improved functional parameters and MR reduction. In conclusion, a successful MitraClip procedure can reverse the process of LA remodeling within 12months, and this can be detected by 2DSTE and RT3DE. Also, patients with preprocedural lower LA-Res and higher 3D-LAV min had the worst prognoses at the 1-year follow-up.

Circulating exosomal microRNAs predict functional recovery after MitraClip repair of severe mitral regurgitation

Circulating exosomal microRNAs predict functional recovery after MitraClip repair of severe mitral regurgitation

Cardiovascular medicine heart failure (CVM-HF) index as prognostic model for candidates to MitraClip therapy.

Transcatheter MitraClip repair is a new tool for the management of severe mitral regurgitation in patients at very high risk for conventional surgery. Aim of our study was reporting one-year clinical outcomes in candidates to MitraClip procedures, divided into three groups according to the cardiovascular medicine heart failure (CVM-HF) index. The study population consists of 46 consecutive patients, divided, in accordance with CVM-HF index, as follows: one patient in the low-risk category (group A); 27 patients in the medium-risk (group B) and 18 patients in high-risk category (group C). The primary study endpoint was a combined of all-cause mortality and re-hospitalization rate. Secondary endpoints were all-cause mortality and cardiac mortality. Patients of group B and group C were compared. Regarding the primary endpoint, patients in group C had significantly poorer outcomes than patients in group B, with a 12-month survival freedom from events of 44.4 and 74.1%, respectively (log-rank test, p=0.039); survival freedom from cardiac mortality was 100 and 83.3% in group B and C, respectively (log-rank test, p=0.027). One-year survival free from re-hospitalization was 74.1% in group B and 39.9% in group C (log-rank test; p=0.036). Survival free from all-cause of mortality was 92.6 and 77.8%, respectively (log-rank test; p=0.129). In our initial experience the CVM-HF index showed to be valuable for understanding if the patient with advanced heart failure and functional mitral regurgitation can really benefit by MitraClip therapy.