Outcomes of transapical mitral valve repair with neochordae implantation.

OBJECTIVE: Transapical off-pump beating-heart neochord implantation (NC) has shown encouraging early results in patients with degenerative mitral regurgitation. The aim of this study was to evaluate clinical and echocardiographic 5-year outcomes of patients who underwent NC. METHODS: All patients who underwent NC at our institution from November 2013 to March 2016 were included. Indications were severe symptomatic degenerative mitral regurgitation due to leaflet prolapse/flail. Patients were classified as having favorable anatomy (FA) and unfavorable anatomy (UA) on the basis of the extent and severity of mitral valve disease. All patients underwent clinical and echocardiographic follow-up at 1, 3, 6, and 12 months, and annually thereafter. Data were prospectively collected and retrospectively analyzed. Outcomes were on the basis of the Mitral Valve Academic Research Consortium guidelines. RESULTS: One hundred consecutive patients were included in the analysis (FA: 81%; UA: 19%). Median age was 66 years (interquartile range, 58-76) and median European System for Cardiac Operative Risk Evaluation (EuroSCORE) II was 1.4% (interquartile range, 0.7-2.3). Technical and procedural success were 98% and 94%, respectively. Thirty-day mortality was 2%. Device success was 94%, 92%, and 78%, at 30 days, 1-year, and 5 years, respectively. Patient success at 1 year was 92%. Median follow-up was 5.1 years. At 5 years, overall survival was 83% with no difference between FA and UA patients. Cumulative incidence of severe mitral regurgitation recurrence at 5 years was 14% (95% CI, 6.5%-22.8%) in FA patients and 63% (95% CI, 39.7%-86.2%) in UA patients, respectively (P < .001). Patients with FA compared with UA had a lower incidence of reintervention (14.7% vs 43.4%; P < .001). CONCLUSIONS: Transapical off-pump beating heart NC might represent an acceptable option in patients with degenerative mitral valve disease and FA.

Novel Transcatheter Mitral Prosthesis Designed to Preserve Physiological Ventricular Flow Dynamics.

BACKGROUND: Current mitral bioprostheses are akin to the aortic valve and therefore abolish the left ventricular (LV) physiological vortex. We evaluated the hemodynamic performance and the effects on intraventricular flow dynamics (IFD) of a novel mitral bioprosthesis that presents an innovative design mimicking the native valve. METHODS: A D-shaped self-expandable stent-bovine pericardium monoleaflet valve was designed to provide physiological asymmetric intraventricular flow. Transapical implantation was consecutively performed in 12 juvenile sheep. Postimplant studies using Doppler echocardiography and IFD using echo particle imaging velocimetry were obtained immediately after the implantation and at 3 months to assess the hemodynamic performance of the prostheses. RESULTS: There were 3 deaths during follow-up, 1 due to valve misplacement because of poor imaging visualization and 2 not valve related. The mean transvalvular gradient and effective orifice area were 2.2 ± 1.2 mm Hg and 4.0 ± 1.1 cm2 after implantation and 3.3 ± 1.5 mm Hg and 3.5 ± 0.5 cm2 at 3 months, respectively. LV vortex dimension, orientation, and physiological anticlockwise rotation were preserved compared with preoperative normal LV flow pattern. One animal showed a moderate paravalvular leak, others mild or none. LV outflow tract obstruction, valve thrombosis, and hemolysis were not observed. CONCLUSIONS: Our preclinical in vivo results confirm the good hemodynamic performance of this new transcatheter bioprosthesis with preservation of the physiological IFD. Clinical studies are needed to document whether these characteristics will foster LV recovery and improve the clinical outcome of patients with mitral regurgitation.

[Current clinical applications of three-dimensional echocardiography]. / Principali applicazioni dell'ecocardiografia tridimensionale nell'attuale pratica clinica.

Three-dimensional echocardiography (3DE) represents one of the most innovative advances in cardiovascular imaging over the last 20 years. Recent technological developments have fueled the full implementation of 3DE in clinical practice and expanded its impact on patient diagnosis, management, and prognosis. One of the most important clinical applications of transthoracic 3DE has been the quantitation of cardiac chamber volumes and function. The main limitations affecting two-dimensional echocardiography calculations of chamber volumes (i.e. geometric assumptions about cardiac chamber shape and view foreshortening) are overcome by 3DE that allows an actual measurement of their volumes. Transesophageal 3DE has been applied mainly to assess the anatomy and function of heart valves, congenital defects and masses in the beating heart. As reparative cardiac surgery and transcatheter procedures have become more and more popular to treat structural heart disease, transesophageal 3DE has become not only one of the main imaging modalities for procedure planning but also for intra-procedural guidance and assessment of procedural results. New image rendering modalities such as 3D printing, holographic display, and fusion of 3DE images with other radiological or nuclear modalities will further expand the clinical applications and indications of 3DE.

Comparison of mitral annulus geometry between patients with ischemic and non-ischemic functional mitral regurgitation: implications for transcatheter mitral valve implantation.

BACKGROUND: Transcatheter mitral valve replacement (TMVR) is a new therapeutic option for high surgical risk patients with mitral regurgitation (MR). Mitral valve (MV) geometry quantification is of paramount importance for success of the procedure and transthoracic 3D echocardiography represents a useful screening tool. Accordingly, we sought to asses MV geometry in patients with functional MR (FMR) that would potentially benefit of TMVR, focusing on the comparison of mitral annulus (MA) geometry between patients with ischemic (IMR) and non ischemic mitral regurgitation (nIMR). METHODS: We retrospectively selected 94 patients with severe FMR: 41 (43,6%) with IMR and 53 (56,4%) with nIMR. 3D MA analysis was performed on dedicated transthoracic 3D data sets using a new, commercially-available software package in two moments of the cardiac cycle (early-diastole and mid-systole). We measured MA dimension and geometry parameters, left atrial and left ventricular volumes. RESULTS: Maximum (MA area 10.7 ± 2.5 cm2 vs 11.6 ± 2.7 cm2, p > 0.05) and the best fit plane MA area (9.9 ± 2.3 cm2 vs 10.7 ± 2.5 cm2, p > 0.05, respectively) were similar between IMR and nIMR. nIMR patients showed larger mid-systolic 3D area (9.8 ± 2.3 cm2 vs 10.8 ± 2.7 cm2, p < 0.05) and perimeter (11.2 ± 1.3 cm vs 11.8 ± 1.5 cm, p < 0.05) with longer and larger leaflets, and wider aorto-mitral angle (135 ± 10° vs 141 ± 11°, p < 0.05). Conversely, the area of MA at the best fit plane did not differ between IMR and nIMR patients (9 ± 1.1 cm2 vs 9.9 ± 1.5 cm2, p > 0.05). CONCLUSIONS: Patients with ischemic and non-ischemic etiology of FMR have similar maximum dimension, yet systolic differences between the two groups should be taken into account to tailor prosthesis's selection. TRIAL REGISTRATION: N.A.

Overview of mitral regurgitation in Europe: results from the European Registry of mitral regurgitation (EuMiClip).

Aims: To determine the prevalence of mitral regurgitation (MR) in a large cohort of consecutive patients undergoing clinically indicated echocardiography and to examine the distribution of primary and secondary MR. Methods and results: All patients undergoing an echocardiographic study in 19 European centres within a 3-month period were prospectively included. MR assessment was performed as recommended by the European Association of Cardiovascular Imaging (EACVI). MR was classified according to mechanism as primary or secondary and aetiologies were reported. A total of 63 463 consecutive echocardiographic studies were reviewed. Any degree of MR was described in 15 501 patients. Concomitant valve disease of at least moderate grade was present in 28.5% of patients, being tricuspid regurgitation the most prevalent. In the subgroup of moderate and severe MR (n = 3309), 55% of patients had primary MR and 30% secondary MR. Both mechanisms were described in 14% of the studies. According to Carpentier's classification, 26.7% of MR were classified as I, 19.9% of MR as II, 22.4% of MR as IIIa, and 31.1% of MR as IIIb. Conclusion: To date, this is the largest echocardiography-based study to analyse the prevalence and aetiology distribution of MR in Europe. The burden of secondary MR was higher than previously described, representing 30% of patients with significant MR. In our environment, degenerative disease is the most common aetiology of primary MR (60%), whereas ischaemic is the most common aetiology of secondary MR (51%). Up to 70% of patients with severe primary MR may have a Class I indication for surgery. However, the optimal therapeutic approach for secondary MR remains uncertain.

Current Clinical Applications of Three-Dimensional Echocardiography: When the Technique Makes the Difference.

Advances in ultrasound, computer, and electronics technology have permitted three-dimensional echocardiography (3DE) to become a clinically viable imaging modality, with significant impact on patient diagnosis, management, and outcome. Thanks to the inception of a fully sampled matrix transducer for transthoracic and transesophageal probes, 3DE now offers much faster and easier data acquisition, immediate display of anatomy, and the possibility of online quantitative analysis of cardiac chambers and heart valves. The clinical use of transthoracic 3DE has been primarily focused, albeit not exclusively, on the assessment of cardiac chamber volumes and function. Transesophageal 3DE has been applied mostly for assessing heart valve anatomy and function. The advantages of using 3DE to measure cardiac chamber volumes derive from the lack of geometric assumptions about their shape and the avoidance of the apical view foreshortening, which are the main shortcomings of volume calculations from two-dimensional echocardiographic views. Moreover, 3DE offers a unique realistic en face display of heart valves, congenital defects, and surrounding structures allowing a better appreciation of the dynamic functional anatomy of cardiac abnormalities in vivo. Offline quantitation of 3DE data sets has made significant contributions to our mechanistic understanding of normal and diseased heart valves, as well as of their alterations induced by surgical or interventional procedures. As reparative cardiac surgery and transcatheter procedures become more and more popular for treating structural heart disease, transesophageal 3DE has expanded its role as the premier technique for procedure planning, intra-procedural guidance, as well as for checking device function and potential complications after the procedure.

Meta-analysis of randomized controlled trials of preprocedural statin administration for reducing contrast-induced acute kidney injury in patients undergoing coronary catheterization.

Preprocedural statin administration may reduce contrast-induced acute kidney injury (CI-AKI), but current evidence is controversial. Randomized controlled trials (RCTs) comparing preprocedural statin administration before coronary catheterization with standard strategies were searched in MEDLINE/PubMed, EMBASE, Scopus, Cochrane Library, Web of Science, and ScienceDirect databases. The outcome of interest was the incidence of postprocedural CI-AKI. Prespecified subgroup analyses were performed according to baseline glomerular filtration rate (GFR), statin type, and N-acetylcysteine use. Eight RCTs were included for a total of 4,984 patients. The incidence of CI-AKI was 3.91% in the statin group (n = 2,480) and 6.98% in the control group (n = 2,504). In the pooled analysis using a random-effects model, patients receiving statins had 46% lower relative risk (RR) of CI-AKI compared with the control group (RR 0.54, 95% confidence interval [CI] 0.38 to 0.78, p = 0.001). A moderate degree of non-significant heterogeneity was present (I(2) = 41.9%, chi-square = 12.500, p = 0.099, τ² = 0.100). In the subanalysis based on GFR, the pooled RR indicated a persistent benefit with statins in patients with GFR <60 ml/min (RR 0.67, 95% CI 0.45 to 1.00, p = 0.050) and a highly significant benefit in patients with GFR ≥60 ml/min (RR 0.40, 95% CI 0.27 to 0.61, p <0.0001). Statin type and N-acetylcysteine or hydration did not significantly influence the results. In conclusion, preprocedural statin use leads to a significant reduction in the pooled RR of CI-AKI.

Transcatheter aortic bioprosthesis dislocation: technical aspects and midterm follow-up.

AIMS: Prosthesis dislocation during transcatheter aortic valve implantation (TAVI) is a rare but important complication. There is scarce data on the performance of prosthesis in the aorta that have become dislocated from their intended anatomical position in the aortic annulus. We investigated the causes of dislocation during TAVI of the self-expanding CoreValve ReValving™ System (CRS) (Medtronic Inc., Minneapolis, MN, USA). This included midterm follow-up of patients experiencing this acute complication. METHODS AND RESULTS: Among 176 consecutive patients undergoing TAVI with the CRS prosthesis, seven (3.9%) experienced acute valve dislocation. A comprehensive analysis of the mechanism of dislocation and clinical outcomes of patients experiencing this complication was performed. Based on the underlying mechanism, all cases of prosthesis displacement were classified into the following three groups: 1) accidental dislocation immediately after valve implantation (n=1; 14.3%); 2) dislocation during the snaring manoeuvre to reposition a low deployment of the CRS prosthesis (lower edge >10 mm) below the aortic annulus accompanied with haemodynamically significant regurgitation (n=4; 57.1%); 3) intentional dislocation performed with the snaring manoeuvre as a bailout in cases of coronary ostia impairment or severe prosthetic leak due to higher deployment for a suboptimal sealing of the device with valve calcifications (n=2; 28.6%). The majority of cases occurred during early experiences with the new Accutrak™ (Medtronic Inc., Minneapolis, MN, USA) delivery system. In six patients a second CRS was implanted in the appropriate position. The dislodged CRS functioned normally, without any evidence of structural deterioration, thrombosis or further distal migration and showed complete apposition against the aortic wall. No thromboembolic events were reported in any patient. CONCLUSIONS: Dislocation of a CRS device can be managed effectively with the implantation of a second device in a standard fashion leaving the dislocated device safely in the aorta. Intentional repositioning of a CRS device in the aorta can be accomplished by experienced operators without any serious neurologic or vascular events in the post-procedure period or at midterm follow-up.

Early- and mid-term outcomes of transcatheter aortic valve implantation in patients with logistic EuroSCORE less than 20%: a comparative analysis between different risk strata.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) is an emerging alternative to medical therapy reserved to a limited population with severe aortic stenosis. The European consensus document recommended TAVI for prohibitive-risk patients not eligible for conventional surgery (prohibitive risk defined as expected mortality ≥ 20% calculated with the Logistic EuroScore (LES) in association with clinical judgment). To date, there is lack of clarity on data about outcomes of TAVI in lower risk patients. We sought to evaluate the outcomes of patients undergoing TAVI with LES ≥ 20% in comparison with patients with LES < 20%. METHOD: Of 165 patients who underwent TAVI using the 18-French Medtronic CoreValve (N = 153) and the Sapien Edwards™ (N = 12) at our Institution between June 2007 and September 2010, we identified those with LES < 20%, with prosthesis implantation (n = 84), and reported on their clinical outcome compared with patients with LES ≥ 20% (n = 78). The primary endpoint was the incidence of overall death and major adverse cerebrovascular and cardiac events (MACCE) at 30-day and midterm follow-up stratifying patients by clinical characteristics. RESULTS: At 30-day, a significant higher incidence of MACCE (20.8% vs. 6.0%, odds ratio [OR] 4.08 95% confidence interval [CI] 1.42-11.74, P = 0.009) and death (15.6% vs. 2.4%, OR 7.45 95% CI 1.61-34.48, P = 0.010) was reported in the LES ≥ 20% group as compared with the LES < 20% group, respectively. The 12-month MACCE rates was (27.1% vs. 11.4%, hazard ratio [HR] 2.47 95% CI 0.93-6.63, P = 0. 071) for LES ≥ 20% and LES < 20% patients, respectively (mortality rates was 25.7% vs. 6.8% HR 4.21 95% CI 1.24-14.30, P = 0.021). CONCLUSION: This study tends to suggest that current mortality reported after TAVI could be significantly affected by the very-high risk profile of the population which currently undergoes this procedure, making comparison with surgical series rather unreliable.

Dual antiplatelet therapy versus aspirin alone in patients undergoing transcatheter aortic valve implantation.

Dual antiplatelet therapy (DAPT) with clopidogrel and aspirin is a widely accepted strategy in patients undergoing transcatheter aortic valve implantation (TAVI), but this approach is not evidence based. The goal of the present study was to determine whether DAPT in patients undergoing TAVI is associated with improved outcomes compared to aspirin alone. From May 2009 to August 2010, consecutive patients were randomized to receive a 300-mg loading dose of clopidogrel on the day before TAVI followed by a 3-month maintenance daily dose of 75 mg plus aspirin 100 mg lifelong (DAPT group) or aspirin 100 mg alone (ASA group). The primary end point was the composite of major adverse cardiac and cerebrovascular events, defined as death from any cause, myocardial infarction, major stroke, urgent or emergency conversion to surgery, or life-threatening bleeding. The cumulative incidence of major adverse cardiac and cerebrovascular events at 30 days and 6 months was 14% and 16%, respectively. No significant differences between the DAPT and ASA groups were noted at both 30 days (13% vs 15%, p = 0.71) and 6 months (18% vs 15%; p = 0.85). In conclusion, the strategy of adding clopidogrel to aspirin for 3 months after TAVI was not found to be superior to aspirin alone. These results must be confirmed in a larger randomized trial.

Management of implant failure during transcatheter aortic valve implantation.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) is an emerging alternative to palliative medical therapy for nonsurgical patients with severe aortic stenosis. There is a paucity of detailed data on the management and outcome of complications related to the sub-optimal deployment of the prosthesis. We appraised the incidence and management of early implant failure occurring during TAVI. METHODS: Of 110 patients who underwent TAVI using the third generation 18-French CoreValve ReValving System (Medtronic, MN) in our Institution between June 2007 and January 2010, we identified those experiencing early implant failure and reported on their management and clinical outcome. The primary endpoint was the incidence of major adverse cardiovascular and cerebrovascular event (MACCE) at 30 days and mid-term follow up. RESULTS: Early implant failure occurred in 18 of 110 patients (16.3%). The most common cause was prosthesis under-expansion conditioning moderate to severe peri-valvular leak (44.4%). Prosthesis deployment too low or too high with respect to the aortic annulus leading to severe peri-valvular leak occurred in 22.2% and 5.5% of patients, respectively. Need of valve retrieve after the first attempt of deployment occurred in four cases (22.2%). Prosthesis embolization in the ascending aorta occurred in 5.5% of patients who experienced early implant failure. All implant failure cases were managed percutaneously with gain in aortic valve area from 0.44 ± 0.17 to 1.28 ± 0.27 cm(2) (P < 0.001), decrease of mean transaortic gradient from 55.00 ± 19.51 to 11.58 ± 5.91 mmHg (P < 0.001) and no MACCE at 30 days. After 11 ± 6 months, MACCE occurred cumulatively in two patients (11.1%). CONCLUSIONS: Early implant failure can complicate the TAVI procedure with the CoreValve system, but it can be managed safely and effectively with bailout transcatheter techniques, avoiding surgery, with good early and mid-term clinical and echocardiographic results.

Balloon aortic valvuloplasty for severe aortic stenosis as a bridge to high-risk transcatheter aortic valve implantation.

OBJECTIVES: To provide data on feasibility, safety and efficacy of balloon aortic valvuloplasty (BAV) as a bridge to transcatheter aortic valve implantation (TAVI). Background. There are no data on BAV use as a bridge to TAVI in patients at high risk of periprocedural complications. METHODS: Between June 2007 to May 2009, 83 consecutive patients with symptomatic severe aortic stenosis (48 female, 35 male) aged from 65 to 88 years (mean age 81 +/- 5 years) were treated with TAVI. Early hemodynamic and clinical outcomes of patients undergoing palliative BAV before TAVI (BAV Group, n = 43) were compared with those of patients who directly underwent TAVI (no-BAV Group, n = 40). RESULTS: Patients in the BAV group had worse baseline clinical characteristics than those in the no-BAV group, with higher rates of congestive heart failure, New York Heart Association (NYHA) functional class III or IV and a higher EuroSCORE. In the BAV group, significant changes were found after valvuloplasty with regard to NYHA functional class, mean pressure gradient and aortic valve area. Peak-to-peak transvalvular pressure gradient and left ventricular systolic pressure also decreased immediately after BAV. Before TAVI, no differences in either clinical status or hemodynamic data were observed between patients who underwent BAV and those who did not. CONCLUSIONS: Bridging to TAVI with BAV is a feasible and reasonably safe approach to offer temporary relief in selected high-risk patients with symptomatic severe aortic stenosis and a high chance of periprocedural complications.