Effects of pericardiocentesis on renal function and cardiac hemodynamics.

BACKGROUND: Previous case studies have reported reversal of acute renal failure after pericardiocentesis in pericardial effusion. This study examines the effects of pericardiocentesis on preprocedural low cardiac output and acute renal dysfunction in patients with pericardial effusion. METHODS: This is a retrospective study of 95 patients undergoing pericardiocentesis between 2015 and 2020. Pre- and post-procedure transthoracic echocardiograms (TTE) were reviewed for evidence of cardiac tamponade, resolution of pericardial effusion, and for estimation of right atrial (RA) pressure and cardiac output. Laboratory values were compared at presentation and post-procedure. Patients on active renal replacement therapy were excluded. RESULTS: Ninety-five patients were included for analysis (mean age 62.2 ± 17.8 years, 58% male). There was a significant increase in glomerular filtration rate pre- and post-procedure. Fifty-six patients (58.9%) had an improvement in glomerular filtration rate after pericardiocentesis (termed "responders"), and these patients had a lower pre-procedure glomerular filtration rate than "non-responders." There was a significant improvement in estimated cardiac output and right atrial pressure for patients in both groups. Patients who had an improvement in renal function had significantly lower pre-procedural diastolic blood pressure and mean arterial pressure. CONCLUSIONS: Pericardial drainage may improve effusion-mediated acute renal dysfunction by reducing right atrial pressure and thus systemic venous congestion, and by increasing forward stroke volume and perfusion pressure.

Comparison of prognostic value among echocardiographic surrogates of right ventricular-pulmonary arterial coupling: A three-dimensional echocardiographic study.

OBJECTIVES: Right ventricular (RV)-pulmonary arterial (PA) coupling is important in various cardiac diseases. Recently, several echocardiographic surrogates for RV-PA coupling have been proposed and reported to be useful in predicting outcomes. However, it remains unclear which surrogate is the most clinically relevant. This study aimed to comprehensively compare the prognostic value of different echocardiographic RV-PA coupling surrogates. METHODS: We retrospectively reviewed 242 patients with various cardiac conditions who underwent comprehensive transthoracic echocardiography with three-dimensional RV data. In addition to conventional parameters including tricuspid annular plane systolic excursion (TAPSE), fractional area change (FAC), and PA systolic pressure (PASP), we analyzed RV free wall and global longitudinal strain (FWLS and GLS). We also obtained RV ejection fraction (RVEF), stroke volume (SV), and end-systolic volume (ESV) using three-dimensional RV analysis. RV-PA coupling surrogates were calculated as TAPSE/PASP, FAC/PASP, FWLS/PASP, GLS/PASP, RVEF/PASP, and SV/ESV. The study endpoint was a composite outcome of all-cause death or cardiovascular hospitalization within 1 year. RESULTS: In multivariable analysis, all the RV-PA coupling surrogates were independent predictors of the outcome. Among the surrogates, the model with TAPSE/PASP showed the lowest prognostic value in model fit and discrimination ability, whereas the model with RVEF/PASP exhibited the highest prognostic value. The partial likelihood ratio test indicated that the model with RVEF/PASP was significantly better than the model with TAPSE/PASP (p < .024). CONCLUSION: All the RV-PA coupling surrogates were independent predictors of the outcome. Notably, RVEF/PASP had the highest prognostic value among the surrogates.

Transcatheter edge-to-edge repair for chronic functional mitral regurgitation in patients with very severe left ventricular dysfunction.

BACKGROUND: There is scarce data on transcatheter edge-to-edge repair (TEER) for chronic functional mitral regurgitation (FMR) in the setting of very severe left ventricular dysfunction (LVD), defined by a left ventricular ejection fraction (LVEF) of <20%. METHODS: We retrospectively explored periprocedural characteristics and one-year clinical and echocardiographic outcomes of consecutive patients with chronic FMR and very severe LVD who underwent an isolated, first-time TEER. The composite of all-cause mortality or heart failure hospitalizations constituted the primary outcome. RESULTS: Ninety-six patients (median age 69 [IQR, 55-76] years, 64 (66.7%) males, median LVEF 15 [IQR, 12-17] %) were included. In 47 (49.0%), TEER was performed urgently or in the setting of hemodynamic instability. Almost all procedures (98.0%) were technically successful, leading to ≤moderate MR in 94.7% and 90.7% of cases by 1-month and 1-year, respectively. New York Heart Association class ≤II was maintained in 60.0% of patients. One-year survival and freedom from the primary outcome were 74.0% and 50.0%, respectively. Functional and echocardiographic improvement compared to baseline was independent of procedural urgency, hemodynamic stability, and downstream left ventricular assist device implantation / heart transplantation (n = 12). Mortality was not predicted by COAPT exclusion criteria, nor was the primary outcome discriminated by published risk models. CONCLUSION: TEER for chronic FMR is feasible, safe, and efficacious in selected patients with very severe LVD. Preprocedural risk stratification in this population may be optimized.

Utility of transesophageal echocardiogram surveillance after watchman device placement.

BACKGROUND: In atrial fibrillation patients undergoing left atrial appendage occlusion with a Watchman device, surveillance imaging with a transesophageal echocardiogram (TEE) is typically performed at 45 days and 1 year to evaluate for device-related thrombus (DRT) and peri-device leak (PDL) before the cessation of oral anticoagulation. The incidence of these complications is relatively low, and the ideal timing and duration of surveillance is unknown. We sought to evaluate the incidence of DRT and PDL after Watchman placement at 45 days and 1 year to determine the necessity of surveillance TEEs. METHODS: We retrospectively analyzed 361 patients who received a Watchman device between January 2016 and January 2020. Baseline clinical and echocardiographic data, post-procedure antithrombotic therapy, and surveillance echocardiographic data were collected from the NCDR LAAO Registry. Nested backward variable elimination regression was performed to derive independent predictors of the composite outcome of DRT and PDL. RESULTS: A total of 286 patients who had post-procedure TEEs were included in the analysis. At 45 days, 9 patients had DRT (3.2%) and 44 patients had PDL (15.0%). At 1 year, 5 patients had DRT (5.6%) and 8 patients had PDL (8.9%). All DRT at 45 days was treated with continued anticoagulation while no change in protocol occurred with PDL. All DRT at 1 year occurred in new patients without prior thrombus. A history of prior transient ischemic attack (TIA) and thromboembolism was significantly associated with DRT or PDL at 1 year. CONCLUSIONS: We identified several patients with device-related complications at 45 days and 1 year despite appropriate device sizing and adequate use of antithrombotic therapy. The incidence of DRT increased from 45 days to 1 year and occurred in patients without prior thrombus. These findings highlight the importance of surveillance imaging and suggest the potential need for extended surveillance in select patients.

Clinical and echocardiographic differences in three different etiologies of severe mitral stenosis.

BACKGROUND: In our institute, the causes of mitral stenosis (MS) are generally categorized into three main etiologies-rheumatic MS (RMS), degenerative MS with annular and leaflet calcification, and post-clip MS as a consequence of transcatheter mitral valve repair with clips for treating mitral regurgitation. However, clinical differences among the three etiologies are uncertain. METHODS: We retrospectively assessed 293 consecutive patients (53 with RMS, 118 with degenerative MS, and 122 with post-clip MS) who had a three-dimensional (3D) transesophageal echocardiography (TEE) derived mitral valve orifice area (MVA) of ≤1.5 cm2 , and a mean transmitral pressure gradient of ≥5 mmHg on transthoracic echocardiography. RESULTS: Although there was no difference in 3D-TEE-derived MVA among the three groups, patients with post-clip MS had a significantly lower mean transmitral pressure gradient compared to those with either of the other two types of MS (10.8 ([7.9-15.2] mmHg vs. 9.6 [7.3-12.5] mmHg vs. 6.9 [6.0-9.2] mmHg; p < .001). Patients with RMS had a higher prevalence of dyspnea. The independent determinants of dyspnea were pressure half time in RMS, 3D-TEE-derived MVA and estimated right atrial pressure in degenerative MS, and left ventricle ejection fraction in post-clip MS. CONCLUSIONS: Patients with post-clip MS had the lowest mean transmitral pressure gradient, and patients with RMS had the highest prevalence of dyspnea, despite having a similar 3D-TEE-derived MVA. The determinants of dyspnea were different among the three etiologies of MS.

Impact of Percutaneous Edge-to-Edge Repair in Patients With Atrial Functional Mitral Regurgitation.

BACKGROUND: The aim of this study was to clarify the clinical outcomes of patients with atrial functional mitral regurgitation (FMR) who underwent the MitraClip procedure compared with those with conventional FMR and sinus rhythm (SR).Methods and Results:Of 303 patients with FMR who underwent the MitraClip procedure, 40 with "atrial-FMR" defined as FMR with permanent atrial fibrillation and normal left ventricular (LV) function/size and 115 with "sinus-FMR" defined as FMR with SR and LV dysfunction were reviewed. Transthoracic and 3D transesophageal echocardiography, and the cardiac complication rate (composite of all-cause death, heart failure admission, mitral valve (MV) surgery, and redo MitraClip procedure) during the 12-month follow-up were compared between the groups. After the MitraClip procedure, reductions in the mitral annular area and its anteroposterior dimension and in the leaflet closure area were observed in both groups. MV orifice area was smaller with greater transmitral pressure gradient (P<0.05) after the procedure in atrial-FMR patients than in those with sinus-FMR. The prevalence of residual MR was similar, but significant tricuspid regurgitation (TR) was more prevalent in the atrial-FMR group at follow-up. Cardiac complication rate was comparable between groups (20% vs. 25%, P=0.63). CONCLUSIONS: Reduction of MR occurred in atrial-FMR probably because of the increase in leaflet coaptation area. Significant TR was more common after the MitraClip procedure in patients with atrial-FMR than with sinus-FMR. However, mid-term outcomes were comparable between patients with atrial-FMR and sinus-FMR.

Left ventricular outflow tract area after percutaneous transseptal transcatheter mitral valve implantation: A three-dimensional transesophageal echocardiography study.

BACKGROUND: Left ventricular (LV) outflow tract (LVOT) obstruction increases mortality in patients undergoing transcatheter mitral valve implantation (TMVI) in degenerated bioprostheses, annuloplasty rings, and native mitral valves. We aimed to evaluate the LVOT area after TMVI using 3-dimensional (3D) transesophageal echocardiography (TEE) and to investigate the preprocedural cardiac geometry that affects the LVOT area after TMVI. METHODS: We retrospectively reviewed echocardiography data in 43 patients who had TMVI. A change in pressure gradient across LVOT from before to after TMVI (∆PG) and postprocedure 3D LVOT cross-sectional area at the level of the most distal portion of the mitral valve stent that was closest to the LV apex were assessed as evidence of LVOT narrowing. RESULTS: Transcatheter mitral valve implantation with the use of balloon-expandable valve system was performed for 24 bioprostheses, 7 annuloplasty rings, and 12 native valves. Compared to patients without increase in LVOT gradient (∆PG <10 mm Hg; n = 33), patients with increase in LVOT gradient (∆PG ≥10 mm Hg; n = 10) had smaller LV end-systolic volume (LVESV), greater LV ejection fraction (LVEF), and smaller aorto-mitral (AM) angle. The LVOT area at the valve stent distal edge showed strong association with ∆PG (r = -.68, P < .0001). Only a small AM angle was associated with a small LVOT area at the valve stent distal edge on multivariable analysis, independent of LVESV and LVEF. CONCLUSION: Small LV size, preserved LVEF, and small AM angle were associated with LVOT narrowing. 3D-derived AM angle might be independently associated with LVOT narrowing in patients undergoing transcatheter mitral valve-in-valve, valve-in-ring, and valve-in-native valve implantation, independent of LVESV and LVEF.

How to Image and Manage Prosthesis-Related Complications After Transcatheter Aortic Valve Replacement.

PURPOSE OF REVIEW: In this review, we provide an overview of potential prosthesis - related complications after transcatheter aortic valve replacement, their incidences, the imaging modalities best suited for detection, and possible strategies to manage these complications. RECENT FINDINGS: Therapy for severe aortic valve stenosis requiring intervention has increasingly evolved toward transcatheter aortic valve replacement over the past decade, and the number of procedures performed has increased steadily in recent years. As more and more centers favor a minimalistic approach and largely dispense with general anesthesia and intra-procedural imaging by transesophageal echocardiography, post-procedural imaging is becoming increasingly important to promptly detect dysfunction of the transcatheter valve and potential complications. Complications after transcatheter aortic valve replacement must be detected immediately in order to initiate adequate therapeutic measures, which require a profound knowledge of possible complications that may occur after transcatheter aortic valve replacement, the imaging modalities best suited for detection, and available treatment options.

Comparison of echocardiographic parameters with cardiac magnetic resonance imaging in the assessment of right ventricular function.

INTRODUCTION: The right ventricle (RV) strain measured by speckle tracking (RVS) is an echocardiographic parameter used to assess RV function. We compared RVS to RV fractional area change (FAC%), tricuspid annular plane systolic excursion (TAPSE) and Doppler tissue imaging-derived peak systolic velocity (S') in the assessment of right ventricular (RV) systolic function measured using cardiac magnetic resonance imaging (MRI). METHODS: We enrolled consecutive patients who underwent cardiac MRI between Jan 2012 and Dec 2017 and a transthoracic echocardiogram (TTE) within 1 month of the MRI with no interval event. Baseline clinical characteristics and MRI parameters were extracted from chart review. Echocardiographic parameters were measured prospectively. TTE parameters including RVS, TAPSE, S', and FAC% were tested for accuracy to identify impaired RV EF (EF < 45% & <30%) using receiver operator curves. RESULTS: The study cohort included 500 patients with mean age 55 years ± 18 and peak tricuspid regurgitation velocity 2.7 ± 1.4 m/s. The area under ROC for RVS was 0.69 (95% CI 0.63-0.75) and 0.78 (95% CI 0.70-0.88) to predict RVEF < 45% & RVEF < 30%, respectively. The RV FAC% had second highest accuracy of predicting RVEF among all the TTE parameters tested in study. CONCLUSION: Right ventricular strain is the most accurate echocardiographic method to detect impaired right ventricular systolic function when using MRI as the gold standard.

Echo-Guided Pericardiocentesis: When and How Should It Be Performed?

PURPOSE OF REVIEW: Abnormal accumulation of pericardial fluid is a common cardiac condition with different etiologies. Draining of the pericardial fluid (pericardiocentesis) is often indicated for diagnostic and therapeutic purposes and is performed in an elective or emergent setting. Echocardiography is the primary imaging method for diagnosing, localizing, and quantifying pericardial effusion as well as evaluating its hemodynamic effects, including the presence of cardiac tamponade. In this manuscript, we review the indications for pericardiocentesis and provide practical step-by-step guidance for echo-guided pericardiocentesis. RECENT FINDINGS: Echo-guidance is an effective method to improve the safety and efficacy of pericardiocentesis. In experienced hands and with a stepwise approach, procedural outcomes are excellent, and complication rates are very low. Asymptomatic small idiopathic effusions have a benign course and can be left untreated. Prolonged drainage with an indwelling pericardial catheter is key for preventing fluid re-accumulation, and the use of colchicine to prevent fluid recurrence is encouraged whenever possible. Understanding how to evaluate the significance of a pericardial effusion as well as the procedural steps in the performance of a pericardiocentesis are essential for optimal outcomes in treating patients with pericardial effusions and tamponade.

Cleft mitral leaflets and severe mitral regurgitation: Testing the limits of percutaneous mitral valve repair.

Repair of mitral regurgitation (MR) with the MitraClip device (Abbot Vascular, Menlo Park, CA) to treat degenerative MR is associated with improved acute and long-term outcomes. There is an increasing adoption of the device and operators are now testing the limits of the therapy even for unfavorable anatomies. Isolated cleft mitral leaflets are rare but represent a challenge to percutaneous repair. We present two cases of successful repair of severe MR and cleft mitral leaflets. In the first case, a 52-year-old male with a dilated cardiomyopathy and an ejection fraction (EF) of 15% presented in decompensated heart failure. Workup revealed a pseudo-cleft anterior mitral leaflet and a cleft posterior leaflet. A strategy to treat the restricted posterior leaflet lateral of the posterior cleft with a provisional second clip resulted in trace residual MR with only one clip, and an EF improvement to 50% at 2-month follow-up. In the second case, an 80-year-old male with a history of obstructive CAD with a normal EF but severe MR and a restricted anterior leaflet presented with severe shortness of breath. An initial strategy to grasp the middle of the valve was unsuccessful due to the cleft. Instead, two clips were placed side-by-side on either side of the cleft resulting in trivial residual MR. Despite challenging anatomy percutaneous repair can allow for dramatic reduction in MR, resulting in significant left ventricular remodeling and improvement of EF and cardiac output.

Degenerative Mitral Regurgitation: Assessment, Physical Examination, and Imaging.

PURPOSE OF REVIEW: In this review, we provide a comprehensive approach to assess degenerative mitral regurgitation. RECENT FINDINGS: In the evaluation of MR, it is important to differentiate between primary (degenerative/organic) MR in which an intrinsic mitral valve lesion(s) is responsible for the occurrence of MR and secondary (functional) MR where the mitral valve is structurally normal, but alterations of the left ventricular geometry cause deterioration of the MV apparatus. Advanced imaging modalities, foremost two-dimensional and three-dimensional echocardiography, are essential for this determination. In the evaluation of degenerative MR, the exact mechanism, the extent of the disease, associated valve lesions, the grade of mitral regurgitation severity, and hemodynamic consequences require careful assessment in order to provide patients with appropriate monitoring and treatment.

Rheumatic Mitral Valve Stenosis: Diagnosis and Treatment Options.

PURPOSE OF REVIEW: This review provides an update on rheumatic mitral stenosis. Acute rheumatic fever (RF), the sequela of group A ß-hemolytic streptococcal infection, is the major etiology for mitral stenosis (MS). RECENT FINDINGS: While the incidence of acute RF in the Western world had substantially declined over the past five decades, this trend is reversing due to immigration from non-industrialized countries where rheumatic heart disease (RHD) is higher. Pre-procedural evaluation for treatment of MS using a multimodality approach with 2D and 3D transthoracic and transesophageal echo, stress echo, cardiac CT scanning, and cardiac MRI as well as hemodynamic assessment by cardiac catheterization is discussed. The current methods of percutaneous mitral balloon commissurotomy (PMBC) and surgery are also discussed. New data on long-term follow-up after PMBC is also presented. For severe rheumatic MS, medical therapy is ineffective and definitive therapy entails PMBC in patients with suitable morphological mitral valve (MV) characteristics, or surgery. As procedural outcomes depend heavily on appropriate case selection, definitive imaging and interpretation are crucial. It is also important to understand the indications as well as morphological MV characteristics to identify the appropriate treatment with PMBC or surgery.

Aortic Regurgitation.

PURPOSE OF REVIEW: Aortic regurgitation (AR) is a common form of valvular disease which is characterized by reflux of blood from the aorta into the left ventricle (LV) during diastole. AR results from various etiologies, affecting the aortic valve cusps or the aortic root. The clinical presentation of patients with AR depends on the severity of the regurgitation and differs whether AR develops acutely or if it progresses over a prolonged period, allowing the cardiac chambers to adapt. Echocardiography is the primary method to determine the etiology of AR and to define its severity. We review the current data regarding the diagnosis and treatment of AR. RECENT FINDINGS: No single parameter is sufficient to determine AR severity; thus, an integrative, multi-parametric approach is required. Echocardiography is key for imaging the aortic valve morphology and flow as well as aortic root and ascending aorta. Determining LV ejection fraction and dimensions is essential for patient management and optimizing timing for intervention. Three-dimensional (3D) echocardiography is useful in the evaluation of AR etiology and severity. The use of Trasncatheter aortic valve replacement (TAVR) has emerged as an alternative to surgery in patients at high operative risk. The diagnosis and management of AR requires a comprehensive approach and routine clinical and echocardiographic follow-up. Surgical or percutaneous therapy is indicated when symptoms develop and in those who have LV dysfunction or LV dilation.

Association of postprocedural aortic regurgitation with mitral regurgitation worsened after transcatheter aortic valve replacement.

BACKGROUND: There is a paucity of investigation which demonstrates a predictor of mitral regurgitation (MR) worsened after aortic valve replacement (TAVR). AIM: The aim of this study was to identify the predictor of worsened MR after transcatheter TAVR. METHODS: We retrospectively studied a total of 209 patients with mild or less MR at baseline who underwent TAVR for the treatment of severe aortic stenosis with the balloon-expandable device. We found the presence of MR worsened after TAVR in 6% (12 patients) of all patients. Moderate or more postprocedural aortic regurgitation (AR) (odds ratio, 8.104; 95% confidence interval, 1.78-36.87; P = .007) was identified as a predictor of MR worsening after TAVR. In-hospital outcomes indicated that patients within whom MR worsened suffered congestive heart failure more than those with unchanged or improved MR after TAVR (P < .05). CONCLUSION: Significant postprocedural AR was associated with MR worsened from mild or less to moderate or more after TAVR. Worsened MR might affect in-hospital congestive heart failure.

Impact of Mitral Annular Displacement on Left Ventricular Diastolic Function Improvement After Transcatheter Aortic Valve Implantation.

BACKGROUND: The clinical significance of left ventricular (LV) diastolic function (DF) improvement after transcatheter aortic valve implantation (TAVI) is not fully elucidated. We sought to investigate the long-term clinical and hemodynamic effects of post-TAVI DF improvement and to identify its determinants.Methods and Results:Clinical and serial echocardiographic data before and after TAVI were retrospectively reviewed together with measurement of mitral annular displacement (MAD) representing longitudinal myocardial function in 98 patients with severe aortic stenosis and ejection fraction >55%. DF grade was determined as 0-III according to the current guideline. Patients with ≥1-grade improvement in DF at 1 year (n=59, 60%) showed a better recovery of New York Heart Association functional class, plasma B-type natriuretic peptide level, stroke volume index, and averaged e', and a greater decrease in systolic pulmonary artery pressure than those without DF improvement (all P<0.05). Coronary artery disease (odds ratio (OR), 0.30; 95% confidence interval (CI), 0.11-0.84; P=0.022) and averaged MAD (per 2.5 mm increase; OR, 4.11; 95% CI, 2.18-7.72; P<0.001) were predictors of post-TAVI DF improvement. An averaged MAD cutoff value of 10.7 mm discriminated cases of improvement with a sensitivity of 88% and specificity of 64%. CONCLUSIONS: Post-TAVI DF improvement may be associated with preserved LV longitudinal function and when present may be accompanied by more favorable clinical and hemodynamic changes.

The Use of MitraClip for Symptomatic Patients with Hypertrophic Obstructive Cardiomyopathy.

OBJECTIVES: Current nonpharmacological therapies for symptomatic patients with hypertrophic obstructive cardiomyopathy (HOCM), including septal myectomy and alcohol septal ablation (ASA), carry significant risks for serious cardiac conduction abnormalities. We present a review of the currently available published data regarding the novel use of the relatively low-risk MitraClip® system in the treatment of symptomatic patients. METHODS: Data were collected from 4 separate studies on the use of the MitraClip on 15 symptomatic HOCM patients with systolic anterior motion (SAM) of the mitral valve apparatus. Information regarding the degree of mitral regurgitation (MR), left-ventricular outflow tract (LVOT) gradient, and NYHA class was consolidated. RESULTS: After MitraClip treatment, all patients had a resolution of SAM, a reduction in MR, and a reduction in the LVOT gradient from a mean of 75.8 ± 39.7 to 11.0 ± 5.6 mm Hg. Nearly all patients demonstrated improvements in symptoms by either new NYHA class designations or improved exercise tolerance. The procedure was not associated with conduction abnormalities or arrhythmias. CONCLUSION: MitraClip therapy may be a safe and effective treatment for symptomatic HOCM patients; it can help to avoid the potential risks associated with alternative therapies in high-risk surgical patients.

Mitral annular motion in patients after transcatheter MitraClip and mitral valve surgery.

BACKGROUND: Longitudinal motion of the mitral annulus is an index that reflects left ventricular (LV) function. The aim of this study was to evaluate and compare the effects of transcatheter mitral valve (MV) repair and open heart surgery for mitral regurgitation (MR) on mitral annular motion (MAM). METHODS: We retrospectively analyzed in total 115 patients who underwent isolated transcatheter MV repair using MitraClip (n=50) or surgical MV interventions (n=65, 50 repairs and 15 replacements) for MR. MAM was assessed by two-dimensional B-mode echocardiography in the four- and two-chamber views. MAM was measured before and within 1 month after the mitral procedure. RESULTS: Compared with patients undergoing MV surgery, patients undergoing the MitraClip procedure were older and had more comorbidities. MR grade improved significantly in both groups after MV intervention. MAM decreased significantly in the surgery group (12.0±3.1 to 8.1±2.2 mm, P<.01), whereas MAM did not change in the MitraClip group (8.8±2.6 to 8.6±2.5 mm, P=.59). In multivariate analysis, mitral surgery was associated with a decrease in MAM when compared to the MitraClip procedure. Furthermore, LV ejection fraction (EF) decreased to a greater degree in patients undergoing surgery than those undergoing MitraClip placement (MV surgery; -10.1±7.6% vs MitraClip; -3.0±10.5%, P<.01). CONCLUSIONS: MitraClip therapy does not adversely influence MAM and is associated with less postprocedural EF reduction compared to surgical intervention. Our results suggest that patients with reduced LV systolic function may benefit from the MitraClip procedure compared to mitral surgery.

The Role of Medical Therapy in Moderate to Severe Degenerative Mitral Regurgitation.

Mitral regurgitation (MR) is a common valvular disorder that has important health and economic consequences. Standardized guidelines exist regarding when and in whom to perform mitral valve surgery, but little information is available regarding medical treatment of MR. Many patients with moderate or severe MR do not meet criteria for surgery or are deemed to be at high risk for surgical therapy. We reviewed the available published data on medical therapy in the treatment of patients with primary MR. b-blockers and renin-angiotensin-aldosterone system inhibitors had the strongest supporting evidence for providing beneficial effects. b-blockers appear to lessen MR, prevent deterioration of left ventricular function, and improve survival in asymptomatic patients with moderate to severe primary MR. Angiotensin-converting enzyme inhibitor and angiotensin receptor blocker therapy reduces MR, especially in asymptomatic patients. However, in the setting of hypertrophic cardiomyopathy or mitral valve prolapse, vasodilators can increase the severity of MR. To define the precise role of medical therapy, a larger randomized controlled trial is needed to confirm benefit and assess in which subsets of patients medical therapy is most useful. Medical therapy in some patients improves symptoms, lessens MR, and may delay the need for surgical intervention.

Clinical trial design principles and endpoint definitions for transcatheter mitral valve repair and replacement: part 1: clinical trial design principles: A consensus document from the mitral valve academic research consortium.

Mitral regurgitation (MR) is one of the most prevalent valve disorders and has numerous aetiologies, including primary (organic) MR, due to underlying degenerative/structural mitral valve (MV) pathology, and secondary (functional) MR, which is principally caused by global or regional left ventricular remodelling and/or severe left atrial dilation. Diagnosis and optimal management of MR requires integration of valve disease and heart failure specialists, MV cardiac surgeons, interventional cardiologists with expertise in structural heart disease, and imaging experts. The introduction of transcatheter MV therapies has highlighted the need for a consensus approach to pragmatic clinical trial design and uniform endpoint definitions to evaluate outcomes in patients with MR. The Mitral Valve Academic Research Consortium is a collaboration between leading academic research organizations and physician-scientists specializing in MV disease from the United States and Europe. Three in-person meetings were held in Virginia and New York during which 44 heart failure, valve, and imaging experts, MV surgeons and interventional cardiologists, clinical trial specialists and statisticians, and representatives from the U.S. Food and Drug Administration considered all aspects of MV pathophysiology, prognosis, and therapies, culminating in a 2-part document describing consensus recommendations for clinical trial design (Part 1) and endpoint definitions (Part 2) to guide evaluation of transcatheter and surgical therapies for MR. The adoption of these recommendations will afford robustness and consistency in the comparative effectiveness evaluation of new devices and approaches to treat MR. These principles may be useful for regulatory assessment of new transcatheter MV devices, as well as for monitoring local and regional outcomes to guide quality improvement initiatives.