Five-Year Clinical and Echocardiographic Outcomes From the NOTION Randomized Clinical Trial in Patients at Lower Surgical Risk.

BACKGROUND: The NOTION trial (Nordic Aortic Valve Intervention) was designed to compare transcatheter aortic valve replacement (TAVR) with surgical aortic valve replacement (SAVR) in patients ≥70 years old with isolated severe aortic valve stenosis. Clinical and echocardiographic outcomes are presented after 5 years. METHODS: Patients were enrolled at 3 Nordic centers and randomized 1:1 to TAVR using the self-expanding CoreValve prosthesis (n=145) or SAVR using any stented bioprostheses (n=135). The primary composite outcome was the rate of all-cause mortality, stroke, or myocardial infarction at 1 year defined according to Valve Academic Research Consortium-2 criteria. RESULTS: Baseline characteristics were similar. The mean age was 79.1±4.8 years and mean Society of Thoracic Surgeons Predicted Risk of Mortality score was 3.0%±1.7%. After 5 years, there were no differences between TAVR and SAVR in the composite outcome (Kaplan-Meier estimates 38.0% versus 36.3%, log-rank test P=0.86) or any of its components. TAVR patients had larger prosthetic valve area (1.7 cm2 versus 1.2 cm2, P<0.001) with a lower mean transprosthetic gradient (8.2 mm Hg versus 13.7 mm Hg, P<0.001), both unchanged over time. More TAVR patients had moderate/severe total aortic regurgitation (8.2% versus 0.0%, P<0.001) and a new pacemaker (43.7% versus 8.7%, P<0.001). Four patients had prosthetic reintervention and no difference was found for functional outcomes. CONCLUSIONS: These are currently the longest follow-up data comparing TAVR and SAVR in lower risk patients, demonstrating no statistical difference for major clinical outcomes 5 years after TAVR with a self-expanding prosthesis compared to SAVR. Higher rates of prosthetic regurgitation and pacemaker implantation were seen after TAVR. CLINICAL TRIAL REGISTRATION: URL: https://clinicaltrials.gov. Unique identifier: NCT01057173.

The future of transcatheter mitral valve interventions: competitive or complementary role of repair vs. replacement?

Transcatheter mitral interventions has been developed to address an unmet clinical need and may be an alternative therapeutic option to surgery with the intent to provide symptomatic and prognostic benefit. Beyond MitraClip therapy, alternative repair technologies are being developed to expand the transcatheter intervention armamentarium. Recently, the feasibility of transcatheter mitral valve implantation in native non-calcified valves has been reported in very high-risk patients. Acknowledging the lack of scientific evidence to date, it is difficult to predict what the ultimate future role of transcatheter mitral valve interventions will be. The purpose of the present report is to review the current state-of-the-art of mitral valve intervention, and to identify the potential future scenarios, which might benefit most from the transcatheter repair and replacement devices under development.

Almanac 2013: novel non-coronary cardiac interventions.

Recent innovations in interventional cardiology have dramatically expanded the therapeutic options for patients with cardiac conditions. Interventional cardiology is no longer limited to the treatment of coronary artery disease but allows also treatment of valvular disease, stroke prevention, hypertension, etc. One of the most important new treatment options is the percutaneous treatment for aortic valve stenosis (transcatheter aortic valve implantation), since aortic valve disease is a rather common problem in elderly patients, with many of them at high risk for surgery. Similarly, mitral regurgitation is often associated with comorbidities which make surgery high risk. The MitraClip is a promising percutaneous alternative to surgical valve repair or replacement. Other procedures discussed in this review are the percutaneous left atrial appendage closure as a non-pharmacologic therapy to prevent strokes, and renal denervation for resistant hypertension. This review explains the basic principles of these procedures, the most important clinical evidence, and also provides additional recent clinical data on each of them.

Almanac 2013: novel non-coronary cardiac interventions.

Recent innovations in interventional cardiology have dramatically expanded the therapeutic options for patients with cardiac conditions. Interventional cardiology is no longer limited to the treatment of coronary artery disease but allows also treatment of valvular disease, stroke prevention, hypertension, etc. One of the most important new treatment options is the percutaneous treatment for aortic valve stenosis (transcatheter aortic valve implantation), since aortic valve disease is a rather common problem in elderly patients, with many of them at high risk for surgery. Similarly, mitral regurgitation is often associated with comorbidities which make surgery high risk. The MitraClip is a promising percutaneous alternative to surgical valve repair or replacement. Other procedures discussed in this review are the percutaneous left atrial appendage closure as a non-pharmacologic therapy to prevent strokes, and renal denervation for resistant hypertension. This review explains the basic principles of these procedures, the most important clinical evidence, and also provides additional recent clinical data on each of these them.

Real-world experience of MitraClip for treatment of severe mitral regurgitation.

BACKGROUND: Percutaneous edge-to-edge mitral valve repair with the MitraClip(®) was shown to be a safe and feasible alternative compared to conventional surgical mitral valve repair. Herein is reported our experience on MitraClip(®) for high-risk surgical candidates with severe mitral regurgitation (MR). METHODS AND RESULTS: Patients with severe MR (3 or 4+) and high operative risk were considered for MitraClip(®) implantation. Device success was defined as placement of 1 or more MitraClips(®) with reduction of MR to ≤2+. Patients were followed up clinically and with echocardiography at 1 year. A total of 27 patients with severe MR (age, 74±12 years; 17 male; logistic EuroSCORE, 27±12; left ventricular ejection fraction, 40±17%) were treated. Fifty-six percent of MR was degenerative and 44% was functional. Device success was 93% with 14 patients receiving 2 clips. MR severity was reduced from 3.5±0.5 to 1.7±0.8 (P<0.001); New York Heart Association class improved from 3.1±0.4 to 2.0±0.8 (P<0.001). In 45% of functional and in 29% of degenerative MR patients, to avoid mitral stenosis, additional MitraClip(®) implantation was not attempted, with resultant transmitral mean gradient of 4.9±1.6mmHg vs. 3.1±1.4mmHg, respectively (P=0.01). CONCLUSIONS: MitraClip(®) was shown to be an effective and safe treatment for patients with both functional and degenerative MR. Inability to obtain a greater reduction of MR was the consequence of borderline transmitral gradient requiring a compromise to avoid mitral stenosis, particularly in the functional MR patients.

Edge-to-edge percutaneous repair of severe mitral regurgitation--state-of-the-art for Mitraclip® implantation.

MitraClip® therapy is a percutaneous edge-to-edge plication of the mitral leaflets, mimicking the Alfieri surgical technique. MitraClip® implantation is a safe procedure, and survival outcomes in high-surgical-risk patients are superior to historical controls. Despite these results, questions remain concerning long-term efficacy and durability. The MitraClip® device has been studied in a safety and feasibility trial in the USA, a randomized pivotal trial against surgical mitral valve repair. Moreover, MitraClip® now has over 2 years of CE-mark approval and a rapidly expanding clinical experience in Europe, primarily in patients at high risk for surgery. A dedicated multidisciplinary team is necessary, as well as thoughtful patient selection, familiarity with the technical aspects of the procedure, including transesophageal ultrasound imaging and post-procedure monitoring. Currently available clinical data and procedural steps are herein reviewed. Because the MitraClip® procedure is still relatively new, continued investigation is required to further better define the patient populations that will benefit most.

Percutaneous edge-to-edge MitraClip therapy in the management of mitral regurgitation.

MitraClip therapy consists of percutaneous edge-to-edge coaptation of the mitral leaflets that is analogous to the surgical Alfieri technique. The safety profile of the MitraClip device is favourable, and survival outcomes in high-surgical-risk patients are superior to historical controls. However, questions remain regarding long-term efficacy and durability. In the U.S.A., the MitraClip device has been studied in a safety and feasibility trial, a randomized pivotal trial against surgical mitral valve repair, and a non-randomized high-risk registry. In addition, the MitraClip now has over 2 years of CE-mark approval and a rapidly expanding clinical experience in Europe, primarily in patients at high risk for surgery. A dedicated multidisciplinary team is necessary, as well as thoughtful patient selection, familiarity with the technical aspects of the procedure including transesophageal ultrasound imaging and post-procedure monitoring. Currently available clinical data are herein reviewed, with emphasis on the current role of MitraClip therapy in relation to existing surgical techniques. Since the MitraClip procedure is still relatively new, continued investigation is required to further define patient populations that will benefit most.

Promising results after percutaneous mitral valve repair.

INTRODUCTION: Mitral valve regurgitation (MR) is the secondmost frequent valve disease in Europe. Untreated MR causes considerable morbidity and mortality. In the elderly, as many as half of these patients are denied surgery because of an estimated high surgical risk. Percutaneous mitral valve repair with the MitraClip system resembles the Alfieristitch where a clip is used to connect the tip of the mitral valve leaflets. MATERIAL AND METHODS: Sixteen patients with MR of various origins (functional/degenerative) were treated with the MitraClip system. All patients were highly symptomatic with dyspnoea (New York Heart Association (NYHA) grade three) and MR grade three or more, and had been turned down for surgery due to an excessively high risk. RESULTS: MR was reduced in all but one patient, generally from grade 3.5±0.5 to grade 1.4±0.9. A total of four patients (25%) received two clips. Thirty-day complications were as follows: one patient died, one had a stroke (speech sequelae), one patient had a new chord rupture that was treated surgically. During 90 days of follow-up, symptoms of dyspnoea diminished (reduction of 1 NYHA grade) and the 6-minute walk test results improved from 171±99 to 339±134 metres (p<0.001). CONCLUSION: Percutaneous mitral valve repair with the MitraClip system is now available in Denmark. The treatment is a reasonable alternative in patients with MR and a high estimated surgery risk. FUNDING: Not relevant. TRIAL REGISTRATION: Not relevant.

Acute outcomes of MitraClip therapy for mitral regurgitation in high-surgical-risk patients: emphasis on adverse valve morphology and severe left ventricular dysfunction.

AIMS: We sought to assess the feasibility of catheter-based mitral valve repair using the MitraClip system in high-surgical-risk patients with mitral regurgitation (MR) > or =grade 3+. METHODS AND RESULTS: MitraClip therapy was performed in 51 consecutive patients [73 +/- 10 years; 34 (67%) men] with symptomatic functional [n = 35 (69%)] or organic MR [n = 16 (31%)]. Mean logistic EuroSCORE was 29 +/- 22%; Society of Thoracic Surgeons score was 15 +/- 11. Left ventricular (LV) ejection fraction was 36 +/- 17%. In 35 patients (69%), adverse mitral valve morphology and/or severe LV dysfunction were present. MitraClip implantation was successful in 49 patients (96%). Most patients [n = 34/49 (69%)] were treated with a single clip, whereas 14 patients (29%) received two clips and one patient received three clips. Mean device and fluoroscopy times were 105 +/- 65 min and 44 +/- 28 min, respectively. Procedure-related reduction in MR severity was one grade in 16 patients (31%), two grades in 24 patients (47%), and three grades in 9 patients (18%). Forty-four of the 49 successfully treated patients (90%) showed clinical improvement at discharge [NYHA functional class > or =III in 48 patients (98%) before and 16 patients (33%) after the procedure (P < 0.0001)]. There were no procedure-related major adverse events and no in-hospital mortality. CONCLUSION: Mitral valve repair using the MitraClip system was shown to be feasible in patients at high surgical risk primarily determined by an adverse mitral valve morphology and/or severe LV dysfunction.

Transcatheter mitral valve repair: an overview of current and future devices.

The field of transcatheter mitral valve repair (TMVr) for mitral regurgitation (MR) is rapidly evolving. Besides the well-established transcatheter mitral edge-to-edge repair approach, there is also growing evidence for therapeutic strategies targeting the mitral annulus and mitral valve chordae. A patient-tailored approach, careful patient selection and an experienced interventional team is crucial in order to optimise procedural and clinical outcomes. With further data from ongoing clinical trials to be expected, consensus in the Heart Team is needed to address these complexities and determine the most appropriate TMVr therapy, either single or combined, for patients with severe MR.

Series of transcatheter valve-in-valve implantations in high-risk patients with degenerated bioprostheses in aortic and mitral position.

OBJECTIVES: We report our experience with transcatheter valve-in-valve implantations in patients with degenerated bioprostheses in aortic and mitral position. BACKGROUND: Xenograft degeneration is a potential problem after biological valve replacement. Reoperation remains the gold standard with very good short- and long-term results. In selected patients not suitable for surgery however, interventional techniques for valve implantation and repair may be valuable alternative treatment options with regard to the good results of transcatheter valve implantation for native aortic valve stenosis. METHODS: Five patients presented with significant xenograft degeneration 15.4 ± 5.2 years after aortic (n = 4) and mitral (n = 1) valve replacement. Mean patient age was 82.0 ± 6.5 years and predicted operative mortality was 55.8% ± 18.9% (logistic EuroSCORE). Transcatheter valve-in-valve implantation was performed successfully through a transapical access in all patients. A 23-mm Edwards Sapien valve was deployed into the degenerated valve prosthesis. RESULTS: Mean transvalvular gradients were reduced from 31.2 ± 17.4 to 19.0 ± 12.4 mm Hg in aortic and from 9 to 3 mm Hg in mitral position without significant regurgitation in any of these patients. Two patients died within 30 days due to low cardiac output and acute hemorrhage, respectively, one of whom presented with a EuroSCORE of 88.9%. CONCLUSIONS: With growing need for reoperative valve replacement in elderly patients with disproportional operative risks, transcatheter valve-in-valve implantation in aortic and mitral position offers an alternative treatment option. Although valve function after transcatheter implantation was good in all patients, two high risk patients died in the postoperative period due to their significant comorbidities, underscoring the bail-out character of this procedure.

An externalized transseptal guidewire technique to facilitate guidewire stabilization and stent-graft passage in the aortic arch.

PURPOSE: To describe a technique to facilitate passage and stable deployment of thoracic stent-grafts in patients with multiple tortuous aortic segments that may hamper endograft delivery or precise placement because of an unstable position in the aortic arch. TECHNIQUE: The technique of a transseptal through-and-through guidewire is demonstrated in a patient with a ruptured thoracic aneurysm with severe tortuosity of the aorta and a right-sided, severely angulated aortic arch. The transseptal through-and-through guidewire stabilization technique allowed successful passage and deployment of a thoracic stent-graft after debranching of the right common carotid and subclavian arteries. The ruptured thoracic aneurysm was excluded, while the proximal graft edge lined up with the origin of the aberrant left innominate artery. CONCLUSION: An externalized transseptal guidewire can facilitate endograft passage in tortuous aortic anatomies and optimize control in most severely angulated aortic arches. It may obviate the use of proximal bare stents because the proximal stent-graft is actively conformed to the inner curve of the aortic arch by the stabilizing wire. Transseptal access to the ascending aorta has the potential to become an important tool for endovascular treatment, especially for catheterization of branches and fenestrations in aortic arch stent-grafts.

Mechanisms underlying air aspiration in patients undergoing left atrial catheterization.

BACKGROUND: Air embolism in patients undergoing percutaneous interventions requiring access to the left atrium (LA) represents a potentially fatal complication. Here we tested if a decline in LA pressures following sedation represents an important mechanistic link underlying air intrusion into the LA. METHODS AND RESULTS: Left atrial pressures were measured in 26 consecutive patients (49 +/- 14 years; 27% male), who underwent percutaneous atrial septal occlusion for persistent foramen ovale or secundum atrial septal defects. Patients either received sedation by propofol allowing for guidance by transesophageal echocardiography (n = 13) or underwent occluder implantation without sedation and under fluoroscopic control only (n = 13). Whereas mean expiratory LA pressures remained unchanged in either group, sedation provoked a marked decline in the mean inspiratory LA pressure as compared to non-sedated patients (Delta p 6.9 +/- 8.6 mm Hg vs. 0.1 +/- 1.2 mm Hg in nonsedated patients, P < 0.001). Ex vivo experiments evaluating the air-tightness of different sheaths in response to negative pressures revealed air aspiration at -13.4 +/- 1.2 mm Hg of suction in all cases, once a guide wire was inserted. CONCLUSIONS: Negative LA pressures in conjunction with air-leaking sheaths are identified as potentially important factors for air intrusion into the LA with the patient's sedation being a primary risk factor to lower LA pressure levels. The results advocate close monitoring of LA pressures during intervention, prevention of airway collapse and protection of LA sheaths from communication with the atmosphere, during procedures under sedation.

Tissue Doppler imaging identifies myocardial dysfunction in adults with Marfan syndrome.

BACKGROUND: Successful prevention of aortic complications has lead to improved survival of Marfan syndrome (MFS). With increasing age, however, ventricular arrhythmia and heart failure are emerging as life-threatening manifestations of myocardial dysfunction. HYPOTHESIS: We sought to investigate whether echocardiography with tissue Doppler imaging (TDI) identifies myocardial dysfunction in adults with MFS. METHODS: We performed two-dimensional (2-D) and Doppler echocardiography with TDI in 141 individuals with suspected MFS and competent heart valves, including 28 persons with MFS who had not undergone surgery and 86 healthy controls without inherited connective tissue disorders. RESULTS: Demographic profile, 2-D, mitral and pulmonary venous flow indices, and left ventricular ejection fractions were similar in both groups. Conversely, isovolumic relaxation time (p < 0.001) and deceleration time of E velocity (p = 0.005) were longer, and atrial reversal velocities (p = 0.02), and systolic and early diastolic TD velocities were slower in MFS than in controls (p = 0.01). Multiple linear regression analysis excluded association of reduced systolic and early diastolic TD velocities with mitral valve prolapse or other clinical or echocardiographic features of MFS. CONCLUSIONS: Our study identifies reduced systolic and early diastolic TD velocities in adults with MFS. Further studies are mandatory to elucidate whether TD velocities predict arrhythmia and heart failure in MFS.

Catheter based simultaneous mapping of cardiac activation and motion: a review.

Heart failure as a result of a variety of cardiac diseases is an ever growing, challenging condition that demands profound insight in the electrical and mechanical state of the myocardium. Assessment of cardiac function has largely relied on evaluation of cardiac motion by multiple imaging techniques. In recent years electrical properties have gained attention as heart failure could be improved by biventricular resynchronization therapy. In contrast to early belief, QRS widening as a result of left bundle branch block could not be identified as a surrogate for asynchronous contraction. The combined analysis of electrical and mechanical function is yet a largely experimental approach. Several mapping system are principally capable for this analysis, the most prominent being the NOGA-XP system. Electromechanical maps have concentrated on the local shortening of the reconstructed endocardial surface from end-diastole to end-systole. Temporal analysis of motion propagation, however, is a new aspect. The fundamental principles of percutaneous catheter based activation and motion assessment are reviewed. Related experimental setups are presented and their main findings discussed.

Immediate and 12-Month Outcomes of Ischemic Versus Nonischemic Functional Mitral Regurgitation in Patients Treated With MitraClip (from the 2011 to 2012 Pilot Sentinel Registry of Percutaneous Edge-To-Edge Mitral Valve Repair of the European Society of Cardiology).

In literature, there are limited data comparing ischemic mitral regurgitation (I-MR) versus nonischemic MR regarding outcomes after percutaneous "edge-to-edge" repair. We aimed to describe the early and 12-month results after MitraClip device implantation regarding the 2 etiologies. From January 2011 to December 2012, the Transcatheter Valve Treatment Sentinel Pilot Registry included 452 patients with MR who underwent MitraClip procedure in 25 centers across Europe. The prevalent etiology was I-MR (235 patients, 52.0%). I-MR group had a significantly higher proportion of men (74.9 vs 59.9%, p <0.001) and surgical risk (logistic EuroSCORE 24.8 ± 18.2 vs 18.8 ± 16.3, p <0.001). Acute procedural success was high (96%) and similar between groups (p = 0.48). Patients with I-MR required a higher, albeit not significant, number of clips to reduce MR (p = 0.08). Inhospital mortality was low (2.0%) without significant differences between etiologies. The estimated 1-year mortality and rehospitalization rates were 15.0% and 25.8%, respectively, without significant differences between groups. Paired echocardiographic data showed a persistent improvement of MR at 1 year in both etiologies. Despite a significant overall reverse atrial remodeling after clip, there were no significant changes in left ventricular volumes. In conclusion, this large independent cohort showed that percutaneous "edge-to-edge" therapy was associated with early- and long-term improvement of MR severity and functional condition both in patients with I-MR and nonischemic MR. There were no significant differences between the 2 etiologies regarding survival and freedom from rehospitalization due to heart failure at the 1-year follow-up.

How to guide stent-graft implantation in type B aortic dissection? Comparison of angiography, transesophageal echocardiography, and intravascular ultrasound.

BACKGROUND: Despite growing interest in stent-graft implantation for type-B aortic dissection, there are no established recommendations to prepare and perform an implantation procedure. METHODS AND RESULTS: We directly compared angiography (ANGIO), transesophageal echocardiography (TEE), and intravascular ultrasound (IVUS) intraprocedually before and after placement of 48 stent grafts in 42 consecutive patients (12 women, 61+/-11 years of age) with acute and chronic type-B aortic dissection for both usefulness and capability to guide aortic stent-graft implantation. Both IVUS and TEE are superior to ANGIO to identify multiple entries (52 and 43 versus 34; P<0.005 each), to diagnose false-lumen slow flow after stent-graft implantation (32 and 31 versus 24; P<0.005 each) and to detect incomplete stent apposition (18 and 16 versus 8; P<0.005 each). In comparison with ANGIO, guide wire position over the entire length of the aorta was documented more frequently by TEE and IVUS (40 and 42 versus 25; P<0.001 each). In 4 patients with abdominal extension of the dissection, only IVUS was able to accurately identify the false lumen over the entire length of the diseased aorta. TEE was superior to IVUS and ANGIO in the detection of endoleaks (5 versus 0 and 1; P<0.05 each). Intraprocedural ANGIO, TEE, and IVUS had been performed without complications in all patients. CONCLUSIONS: TEE in conjunction with ANGIO appears to be advantageous and adds incremental information to safely guide stent-graft placement in type-B aortic dissection. Additional use of IVUS was found to be helpful in patients with complex anatomy and abdominal extension of the dissection.

Simultaneous mapping of activation and motion timing in the healthy and chronically ischemic heart.

BACKGROUND: Experimental data of simultaneous acquired activation and motion (AM) propagation from human subjects are not available. OBJECTIVES: The purpose of this study was to demonstrate the feasibility of a novel mapping technique allowing combined analysis of AM timing in vivo and to delineate the influence of chronically ischemic tissue on cardiac AM propagation. METHODS: Ten patients with remote myocardial infarction and 4 control patients were studied during sinus rhythm using electroanatomic mapping (CARTO). Maps of the left ventricle were obtained via the retrograde aortic approach. Real-time catheter positions were extracted using custom-made software. Catheter motion was analyzed along a static line connecting the catheter tip with the apex. Tissue Doppler measurements in all patients provided data for validation. RESULTS: Four shapes of catheter motion curves were identified and correlated to healthy tissue with variable degrees of preloading, scar tissue and dyskinetic regions, e.g. aneurysms. An analysis of the AM-delay revealed areas of delayed activation in 7, and slow motion onset in 4 patients. Tissue Doppler data correlated well with local onset of motion (correlation coefficient 0,99). CONCLUSION: Activation delays as well as long AM-intervals that can be differentiated with the described mapping technique are responsible for asynchronous contraction in the ischemic heart. Myocardial wall motion abnormalities can be derived from catheter motion curves.

Impact of Preprocedural Left Ventricular Ejection Fraction on 1-Year Outcomes After MitraClip Implantation (from the ACCESS-EU Phase I, a Prospective, Multicenter, Nonrandomized Postapproval Study of the MitraClip Therapy in Europe).

This report describes the 12-month outcomes of the a prospective, multicenter, nonrandomized post-approval study of the MitraClip therapy in Europe (ACCESS-EU postapproval study of MitraClip therapy) with respect to preprocedural left ventricular ejection fraction (LVEF). Transcatheter deployment of the MitraClip device may be considered for patients who are not suitable for conventional surgery. A total of 567 patients with significant mitral regurgitation (MR) underwent MitraClip therapy. Of those, 393 had functional MR (FMR) and were subdivided by preprocedural LVEF (A: 10% to 20%, B: >20% to 30%, C: >30% to 40%, D: >40%). Procedural safety and efficacy and treatment outcomes including MR grade, New York Heart Association (NYHA) functional class, 6-minute walk test, and the Minnesota Living with Heart Failure Questionnaire were analyzed at baseline, 30 days, and 12 months. Baseline mean logistic EuroSCORE was 25 ± 19; 87% of patients were in NYHA classes III or IV (A: 96%, B: 83%, C: 90%, D: 86%). There was no incidence of death or stroke intraprocedurally. Eleven patients died within 30 days with no differences among subgroups. Kaplan-Meier survival at 12 months was 81.8% (A: 71%, B: 79%, C: 87%, D: 86%). There was a significant improvement in MR severity at 30 days and 12 months (p <0.0001). At 12 months, all subgroups experienced similar improvements in NYHA class, 6-minute walk test, and Minnesota Living with Heart Failure Questionnaire. This real-world registry reports promising results of MitraClip therapy in patients with FMR. In conclusion, the low rates of hospital mortality and adverse events in patients with FMR-even in patients with severely reduced LVEF-provide additional evidence of substantial benefits after MitraClip implantation.