Moody Makar

Aortic annular sizing for transcatheter aortic valve replacement using cross-sectional 3-dimensional transesophageal echocardiography.

OBJECTIVES This study compared cross-sectional three-dimensional (3D) transesophageal echocardiography (TEE) to two-dimensional (2D) TEE as methods for predicting aortic regurgitation after transcatheter aortic valve replacement (TAVR). BACKGROUND Data have shown that TAVR sizing using cross-sectional contrast computed tomography (CT) parameters is superior to 2D-TEE for the prediction of paravalvular aortic regurgitation (AR). Three-dimensional TEE can offer cross-sectional assessment of the aortic annulus but its role for TAVR sizing has been poorly elucidated. METHODS All patients had severe symptomatic aortic stenosis and were treated with balloon-expandable TAVR in a single center. Patients studied had both 2D-TEE and 3D imaging (contrast CT and/or 3D-TEE) of the aortic annulus at baseline. Receiver-operating characteristic curves were generated for each measurement parameter using post-TAVR paravalvular AR moderate or greater as the state variable. RESULTS For the 256 patients studied, paravalvular AR moderate or greater occurred in 26 of 256 (10.2%) of patients. Prospectively recorded 2D-TEE measurements had a low discriminatory value (area under the curve = 0.52, 95% confidence interval: 0.40 to 0.63, p = 0.75). Average cross-sectional diameter by CT offered a high degree of discrimination (area under the curve = 0.82, 95% confidence interval: 0.73 to 0.90, p < 0.0001) and mean cross-sectional diameter by 3D-TEE was of intermediate value (area under the curve = 0.68, 95% confidence interval: 0.54 to 0.81, p = 0.036). CONCLUSIONS Cross-sectional 3D echocardiographic sizing of the aortic annulus dimension offers discrimination of post-TAVR paravalvular AR that is significantly superior to that of 2D-TEE. Cross-sectional data should be sought from 3D-TEE if good CT data are unavailable for TAVR sizing.

Impact of pulmonary hypertension on outcomes in patients with functional mitral regurgitation undergoing percutaneous edge-to-edge repair.

Preexisting pulmonary hypertension (PH) is associated with poor outcomes after surgical mitral valve repair for functional mitral regurgitation (FMR). However its clinical impact on MitraClip therapy remains unknown. The aim of this study was therefore to evaluate the impact of preexisting PH on MitraClip therapy for patients with FMR. Ninety-one consecutive patients who had FMR and who underwent the MitraClip procedure were studied. They were divided into 2 groups on the basis of pulmonary artery systolic pressure: the PH group (n = 48) and the non-PH group (n = 43). PH was defined as pulmonary artery systolic pressure >50 mm Hg using Doppler echocardiography. Procedural success (defined as magnetic resonance reduction to grade 2+ or less) and 30-day mortality were similar in the 2 groups. At 12 months, New York Heart Association functional class had improved to class I or II in most patients in the PH (from 2.9% to 94.3%) and non-PH (from 9.4% to 96.9%) groups. The mean pulmonary artery systolic pressure of the PH group significantly decreased from baseline but remained higher than that of the non-PH group (50.8 ± 15.3 vs 36.7 ± 11.6 mm Hg, p <0.001). After a mean of 25.0 ± 16.9 months of follow-up, Kaplan-Meier analysis demonstrated significantly higher all-cause mortality in the PH group. In Cox regression analysis, preexisting PH was the most powerful predictor of all-cause mortality (hazard ratio 3.731, 95% confidence interval 1.653 to 8.475, p = 0.002). In conclusion, MitraClip therapy reduced FMR and alleviated symptoms with an excellent early safety profile in the PH and non-PH groups. However, preexisting PH was associated with worse all-cause mortality.

Compassionate use of the PASCAL transcatheter mitral valve repair system for patients with severe mitral regurgitation: a multicentre, prospective, observational, first-in-man study

BACKGROUND Severe mitral regurgitation is associated with impaired prognosis if left untreated. Using the devices currently available, transcatheter mitral valve repair (TMVr) remains challenging in complex anatomical situations. We report the procedural and 30-day results of the first-in-man study of the Edwards PASCAL TMVr system. METHODS In this multicentre, prospective, observational, first-in-man study, we collected data from seven tertiary care hospitals in five countries that had a compassionate use programme in which patients underwent transcatheter mitral valve repair using the Edwards PASCAL TMVr system. Eligible patients were those with symptomatic, severe functional, degenerative, or mixed mitral regurgitation deemed at high risk or inoperable. Safety and efficacy of the procedure were prospectively assessed at device implantation, discharge, and 30 days after device implantation. The key study endpoints were technical success assessed at the end of the procedure and device success 30 days after implantation using the Mitral Valve Academic Research Consortium definitions. FINDINGS Between Sept 1, 2016, and March 31, 2017, 23 patients (median age 75 years [IQR 61-82]) had treatment for moderate-to-severe (grade 3+) or severe (grade 4+) mitral regurgitation using the Edwards PASCAL TMVr system. At baseline, the median EuroScore II score was 7·1% (IQR 3·6-12·8) and the median Society of Thoracic Surgeons predicted risk of mortality for mitral valve repair was 4·8% (2·1-9·0) and 6·8% (2·9-10·1) for mitral valve replacement. 22 (96%) of 23 patients were New York Heart Association (NYHA) class III or IV at baseline. The implantation of at least one device was successful in all patients, resulting in procedural residual mitral regurgitation of grade 2+ or less in 22 (96%) patients. Six (26%) of 23 patients had two implants. Periprocedural complications occurred in two (9%) of 23 patients (one minor bleeding event and one transient ischaemic attack). Despite the anatomical complexity of mitral regurgitation in the patients in this compassionate use cohort, technical success was achieved in 22 (96%) of 23 patients, and device success at 30 days was achieved in 18 (78%) patients. Three patients (13%) died during the 30 day follow-up. 19 (95%) of 20 patients alive 30 days after implantation were NYHA class I or II. INTERPRETATION This study establishes feasibility of the Edwards PASCAL TMVr system with a high rate of technical success and reduction of mitral regurgitation severity. Further research is needed on procedural and long-term clinical outcomes. FUNDING None.

Perioperative Coagulopathy, Bleeding, and Hemostasis During Cardiac Surgery: A Comprehensive Review

Cardiac surgery patients use 10%-25% of the blood products transfused annually in the United States. The transfusion of red blood cells or blood products has been the subject of intense scrutiny over the past 10 years. Bleeding after cardiac surgery can be surgical or nonsurgical and lead to hemodynamic compromise and surgical reexploration. Because hemorrhage and blood product transfusions are associated with multiple negative outcomes, including increased mortality, it is prudent to understand the mechanisms responsible for nonsurgical bleeding. This review focuses on the physiology of the normal coagulation and fibrinolysis, risk factors associated with patients presenting for cardiac surgery, impairments of normal hemostasis associated with cardiac surgery and cardiopulmonary bypass (CPB), and potential interventions to reduce perioperative blood loss and blood transfusion.

Optimal use of echocardiography in valvular heart disease evaluation

### Learning objectives Non-invasive imaging Patients with valvular heart disease (VHD) can be asymptomatic or present with a wide range of symptoms that may not correlate with the severity of valve dysfunction. Transthoracic echocardiography (TTE) and transoesophageal echocardiography (TEE) combining 2D, 3D and Doppler evaluation provide the clinician with valuable and complimentary information on heart valve structure, function and the physiological consequences of the valvular lesion. This non-invasive methodology provides crucial information during the initial clinical evaluation and at follow-up. Current guidelines recommend TTE as the initial diagnostic test to evaluate patients with known or suspected VHD.1 ,2 While 2D and M-mode TTE can assess valvular motion, morphology and pathology (when present), Doppler provides requisite information on valve haemodynamics, flow velocities across the valve, pressure gradients and calculation of valve area as well as haemodynamic data regarding pulmonary artery pressure and left ventricular (LV) filling parameters. In addition, colour flow Doppler and spectral Doppler provide critical information on valve regurgitation and stenosis severity. Exercise Doppler echocardiography is useful to assess the impact of exercise on valvular and ventricular function as well as the patients functional capacity. The severity of a valvular lesion is determined using a multiparameter echo Doppler assessment. ### Aortic stenosis Echocardiography is the imaging modality of choice for diagnosing and estimating the severity of aortic stenosis (AS). The different echocardiographic methods used for evaluation of the aortic valve (AV) for the presence of stenosis are detailed in table 1. TTE is the most well-established imaging modality for evaluating and assessing the severity of AS.1 As shown in figure 1, valve anatomy should …

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.

AIMS 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. METHODS AND RESULTS 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). CONCLUSIONS 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.

Comparison of mitral valve geometrical effect of percutaneous edge-to-edge repair between central and eccentric functional mitral regurgitation: clinical implications

AIMS Percutaneous edge-to-edge repair alters mitral valve (MV) geometry in functional mitral regurgitation (FMR). We sought to characterize MV morphology in patients with central and eccentric FMR, compare the geometrical effect of MitraClip therapy, and elucidate different mechanisms of MR improvement according to FMR subtypes. METHODS AND RESULTS Seventy-six symptomatic patients with Grade 3 to 4+ FMR (central, n = 39; eccentric, n = 37) underwent three-dimensional transoesophageal echocardiography during MitraClip implantation. We defined procedural success as a reduction of MR by ≥1 grade with having a residual mitral regurgitation (MR) of ≤ grade 2+. Procedural success rate was similar between central and eccentric FMR (77% vs. 78%, P = 0.55). After MitraClip, the reduction in anterior-posterior diameter did not differ between FMR subtypes, but patients with eccentric FMR had a greater reduction in the averaged tethering angle difference (P < 0.001) with less reduction in tenting volume and height (both P < 0.001) than did patients with central FMR. On multivariable analysis, in central FMR, MR reduction post-clip was associated with shortening in anterior-posterior diameter [coefficient 0.388, 95% confidence interval (CI) 0.216-0.561; P < 0.001] and an increase in coaptation area (coefficient 0.117, 95% CI 0.039-0.194; P = 0.004), whereas in eccentric FMR MR reduction was mainly associated with a decrease in the averaged tethering angle difference (coefficient 0.050, 95% CI 0.021-0.078; P = 0.001). CONCLUSION MV geometrical effect and its association with MR improvement after MitraClip therapy differ according to FMR subtypes. Our results indicate the MR jet direction and the leaflet tethering pattern may be considered in the strategy for percutaneous treatment for FMR.

Impact of Forward Stroke Volume Response on Clinical and Structural Outcomes After Percutaneous Mitral Valve Repair With MitraClip

Background— An increase of systolic forward flow was frequently observed after successful MitraClip implantation in patients with significant mitral regurgitation. However, the impact of systolic forward flow improvement on post–MitraClip outcomes remains unknown. Methods and Results— Study population included 160 patients who underwent successful MitraClip implantation. The systolic forward flow was noninvasively calculated as the forward stroke volume (FSV) at baseline before the MitraClip procedure and before discharge with pulse-wave Doppler using transthoracic echocardiography. The optimal threshold of discharge/baseline FSV ratio for 3-year all-cause death was assessed. The best cutoff ratio was 1.09 (9% FSV increase from baseline, P=0.006). The FSV responders were defined as those with >9% increase of FSV from baseline (n=93). From discharge to 12-month follow-up, a significant reduction of LV end-diastolic and end-systolic volumes was observed in the responders, whereas no significant change was observed in the nonresponders. Furthermore, the proportion of New York Heart Association functional class III/IV was significantly lower in the responders at 12 months (2.9% versus 14.6%; P=0.03). Among patients with estimated glomerular filtration rate <60 mL/min per 1.73 m2, estimated glomerular filtration rate was significantly improved at 12 months only in the responders. All-cause mortality at 3 years was significantly lower in the responders than in the nonresponders (17.6% versus 42.3%; P=0.002). Multivariable logistic analysis identified higher baseline FSV, less mitral regurgitation severity, and functional mitral regurgitation as independent predictors of the nonresponders. Conclusions— FSV increase after MitraClip implantation was associated with more favorable clinical and anatomic outcomes. Severity and pathogenesis of mitral regurgitation and pre-MitraClip FSV predicted postprocedural FSV response.

PREOPERATIVE PULMONARY HYPERTENSION HAS AN ADVERSE EFFECT IN PATIENTS WITH FUNCTIONAL MITRAL REGURGITATION UNDERGOING THE MITRACLIP PROCEDURE

MitraClip (Abbott Vascular, Menlo Park, California) is an effective low risk transcatheter treatment option for the treatment of functional mitral regurgitation (FMR). Pulmonary hypertension (PH) is a predictor of adverse outcome following mitral valve surgery. However, the prognostic implications

TCT-795 Procedural success is improved with a 2nd MitraClip placement without additional complications

Suboptimal result of the MitraClip procedure (Abbott Vascular, Santa Clara, California) might be related to inadequate number of clips. In some cases of the MitraClip procedure, 2nd clip is required to be placed for residual mitral regurgitation (MR) after 1st clip placement. However the reports of