Clinical and echocardiographic outcomes of transcatheter mitral valve repair in atrial functional mitral regurgitation.

BACKGROUND: Isolated atrial fibrillation can cause mitral regurgitation (MR) in patients with normal left ventricular systolic function and no organic disease of the mitral valve. Little information is available regarding outcomes of Mitraclip in patients with atrial functional mitral regurgitation (AFMR). We aimed to evaluate 12-month clinical and echocardiographic outcomes of transcatheter mitral valve repair (TMVR) with MitraClip in patients with AFMR compared to those with ventricular functional or degenerative/mixed MR. METHODS: Registry-based analysis of all consecutive patients who underwent TMVR and were included in the Spanish Registry of Mitraclip. Changes in MR and NYHA functional class, and a combined endpoint including all-cause mortality and hospitalizations due to heart failure were the main outcomes. RESULTS: Overall, 1074 (69.1% male, 73.3 ± 10.2 years-old) patients were analyzed in this report. 48 patients (4.5%) presented AFMR. AFMR was significantly reduced after TMVR, with a procedural success rate of 91.7%, and this reduction persisted at 12-month (p < 0.001). Patients with AFMR showed a significant functional improvement at 6- and 12-month follow-up in our series (baseline: NYHA III 70.8% IV 18.8% vs. 1-year: NYHA III 21.7% IV 0%; p < 0.001). The probability of survival free of readmission for heart failure and all-cause mortality within the first year after TMVR was 74.9%. Procedural and clinical outcomes, as well as recurrent rates of MR were similar acutely and at 1-year compared to other etiologies. CONCLUSION: TMVR in patients with AFMR showed no significant differences compared to ventricular functional or degenerative/mixed MR regarding MR reduction or clinical outcomes.

Prognostic Role of TAPSE to PASP Ratio in Patients Undergoing MitraClip Procedure.

BACKGROUND: Transcatheter mitral valve repair (TMVR) is an effective therapy for high-risk patients with severe mitral regurgitation (MR) but heart failure (HF) readmissions and death remain substantial on mid-term follow-up. Recently, right ventricular (RV) to pulmonary arterial (PA) coupling has emerged as a relevant prognostic predictor in HF. In this study, we aimed to assess the prognostic value of tricuspid annular plane systolic excursion (TAPSE) to PA systolic pressure (PASP) ratio as a non-invasive measure of RV-to-PA coupling in patients undergoing TMVR with MitraClip (Abbott, CA, USA). METHODS: Multicentre registry including 228 consecutive patients that underwent successful TMVR with MitraClip. The sample was divided in two groups according to TAPSE/PASP median value: 0.35. The primary combined endpoint encompassed HF readmissions and all-cause mortality. RESULTS: Mean age was 72.5 ± 11.5 years and 154 (67.5%) patients were male. HF readmissions and all-cause mortality were more frequent in patients with TAPSE/PASP ≤ 0.35: Log-Rank 8.844, p = 0.003. On Cox regression, TAPSE/PASP emerged as a prognostic predictor of the primary combined endpoint, together with STS-Score. TAPSE/PASP was a better prognostic predictor than either TAPSE or PASP separately. CONCLUSIONS: TAPSE/PASP ratio appears as a novel prognostic predictor in patients undergoing MitraClip implantation that might improve risk stratification and candidate selection.

Percutaneous Mitral Valve Repair: Outcome Improvement with Operator Experience and a Second-Generation Device.

BACKGROUND AND AIM: Recent randomized data comparing percutaneous mitral valve repair (PMVR) versus optimal medical treatment in patients with functional MR (FMR) seemed to highlight the importance of the learning curve not only for procedural outcomes but also for patient selection. The aim of the study was to compare a contemporary series of patients undergoing PMVR using a second-generation Mitraclip device (Mitraclip NT) with previous cohorts treated with a first-generation system. METHODS: This multicenter study collected individual data from 18 centers between 2012 and 2017. The cohort was divided into three groups according to the use of the first-generation Mitraclip during the first (control-1) or second half (control-2) or the Mitraclip NT system. RESULTS: A total of 545 consecutive patients were included in the study. Among all, 182 (33.3%), 183 (33.3%), and 180 (33.3%) patients underwent mitral repair in the control-1, control-2, and NT cohorts, respectively. Procedural success was achieved in 93.3% of patients without differences between groups. Major adverse events did not statistically differ among groups, but there was a higher rate of pericardial effusion in the control-1 group (4.3%, 0.6%, and 2.6%, respectively; p = 0.025). The composite endpoint of death, surgery, and admission for congestive heart failure (CHF) at 12 months was lower in the NT group (23.5% in control-1, 22.5% in control-2, and 8.3% in the NT group; p = 0.032). CONCLUSIONS: The present paper shows that contemporary clinical outcomes of patients undergoing PMVR with the Mitraclip system have improved over time.

Transcatheter mitral repair according to the cause of mitral regurgitation: real-life data from the Spanish MitraClip registry.

INTRODUCTION AND OBJECTIVES: Transcatheter mitral valve repair (TMVR) with MitraClip is a therapeutic option for high surgical risk patients with severe mitral regurgitation (MR). The main objective of this study was to analyze differences in outcomes in patients with severe MR according to the cause of MR. METHODS: Observational, multicenter, and prospective study with consecutive patient inclusion. The primary endpoint was the combination of all-cause mortality and new readmissions due to heart failure after 1 year. We compared clinical and procedural characteristics and the event rate for each MR group. We performed a multivariate analysis to identify predictive variables for the primary endpoint. RESULTS: A total of 558 patients were included: 364 (65.2%) with functional etiology, 111 (19.9%) degenerative and 83 (14.9%) mixed. The mean age was 72.8±11.1 years and 70.3% of the sample were men. There were 95 (17%) events in the overall sample. No significant differences were found in the 3 groups in the number of primary outcome events: 11 (11.3%) in degenerative MR, 71 (21.3%) in functional MR, and 13 (18.1%) in mixed MR (P=.101). Independent predictors were functional class (P=.029), previous surgical revascularization (P=.031), EuroSCORE II (P=.003), diabetes mellitus (P=.037), and left ventricular ejection fraction (P=.015). CONCLUSIONS: This study confirms the safety and efficacy of TMVR with MitraClip irrespective of MR etiology in real-life data and shows the main factors related to prognosis during the first year of follow up.

Significant transaortic gradient after direct flow aortic valve implantation.

A patient with severe aortic valve disease and high surgical risk underwent Direct Flow (DF) valve implantation. Anatomical assessment (Trans-esophageal echocardiography (TEE) and CT scan) revealed a 3-leaflet aortic valve (annulus diameter 23.4 mm) that was functionally bicuspid because of complete and linearly calcified fusion of noncoronary and right cusps. The valve had severe stenosis (peak/mean gradients of 70/45 mm Hg) and moderate to severe regurgitation. A balloon valvuloplasty (semicompliant 23 mm × 45 mm balloon, 2 inflations) was performed with persistence of balloon waist. A 25 DF valve was positioned in the aortic annulus, with both rings well expanded. A mild deformity in the vertical supporting tubes was observed but considered nonrelevant because valve function (peak/mean gradients of 25/12 mm Hg respectively and no aortic regurgitation) was acceptable. Then the polymer was injected and the valve released from its attachments. Postoperative course was uneventful without clinical complications; nevertheless 3 days later Doppler peak/mean transaortic gradients were 80/45 mm Hg. These high gradients were confirmed by direct invasive measurements while CT scan documented a severe geometrical deformation of the valve cuff. Since patient was in good clinical condition, a conservative strategy was adopted. Eight months later, patient functional status had improved (NYHA class II), left ventricular dimensions decreased, left ventricular ejection fraction (LVEF) increased, and valve gradients remained unchanged; therefore surgical aortic valve replacement has been deferred until clinical indication. Such a favorable course can be explained by disappearance of aortic regurgitation. Patient anatomical and procedural features that conditioned this very rare phenomenon are discussed as well as clues to prevent it.

Management of ST-elevation myocardial infarction according to European and American guidelines.

AIMS: To highlight differences between the most recent guidelines of the European Society of Cardiology (ESC) and the American College of Cardiology Foundation/American Heart Association (ACCF/AHA) on the management of ST-elevation myocardial infarction (STEMI). METHODS AND RESULTS: ESC 2012 and ACCF/AHA 2013 guidelines on the management of STEMI were systematically reviewed for consistency. Recommendations were matched, directly compared in terms of class of recommendation and level of evidence, and classified as "identical", "overlapping", or "different". Out of 32 recommendations compared, 26 recommendations (81%) were classified as identical or overlapping, and six recommendations (19%) were classified as different. Most diverging recommendations were related to minor differences in class of recommendation between the two documents. This applies to recommendations for reperfusion therapy >12 hours after symptom onset, immediate transfer of all patients after fibrinolytic therapy, rescue PCI for patients with failed fibrinolysis, and intra-aortic balloon pump use in patients with cardiogenic shock. More substantial differences were observed with respect to the type of P2Y12 inhibitor and duration of dual antiplatelet therapy. CONCLUSIONS: The majority of recommendations for the management of STEMI according to ESC and ACCF/AHA guidelines were identical or overlapping. Differences were explained by gaps in available evidence, in which case expert consensus differed between European and American guidelines due to divergence in interpretation, perception, and culture of medical practice. Systematic comparisons of European and American guidelines are valuable and indicate that interpretation of available evidence leads to agreement in the vast majority of topics. The latter is indirect support for the process of review and guideline preparation on both sides of the Atlantic.

Quality of life improvement at midterm follow-up after transcatheter aortic valve implantation.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) techniques have been presenting good procedural success and favorable clinical outcomes. However, optimal management of aortic valve disease in elderly patients depends on quality of life (QoL) improvement. In this study we aimed to evaluate changes in QoL in patients referred for TAVI. METHODS AND RESULTS: Prospective analysis of 74 consecutive patients (34 male), aged 81.6 ± 8 years with symptomatic severe aortic valve stenosis (AS) ineligible for conventional aortic valve replacement, referred to TAVI in one tertiary center. For the assessment of QoL, the Minnesota Living with Heart Failure Questionnaire (MLHFQ) was used before the procedure and at 6.5 months. The mortality was 9.5% at 30 days and 20.2% at 6.5 months follow-up. Fifty three (71.6%) patients completed MLHFQ at baseline and at follow-up. All patients showed good hemodynamic results and no signs of prosthesis dysfunction were observed on transthoracic echocardiography. The New York Heart Association (NYHA) class (2.9 ± 0.4 to 1.4 ± 0.7; p<0.001), and the MLHFQ scores [overall (37.0 ± 14.7 vs. 14.4 ± 10.1; p<0.001), physical dimension (23.2 ± 9.5 vs. 8.6 ± 5.9; p<0.001) and emotional dimension (5.4 ± 4.2 vs. 2.6 ± 3.0; p<0.001)] were significantly improved 6.5 months after TAVI. Patients with peripheral vascular disease (PVD) had an inferior improvement in QoL caused by a lower enhancement in physical dimension MLHFQ score (mean difference: -17.0 ± 10.2 vs. -10.1 ± 11.5; p=0.036). CONCLUSION: TAVI significantly improves symptoms and QoL in patients with severe AS and high surgical risk. Patients with PVD might be expected to have a less impressive improvement in QoL after TAVI.

[Atrioventricular conduction disturbances after CoreValve(®) aortic prosthesis implantation. Predictive role of transesophageal echocardiography]. / Trastornos de conducción auriculoventricular tras implantación de prótesis aórtica CoreValve(®). Papel predictivo de la ecocardiografía transesofágica.

Atrioventricular conduction disorders can appear after the implantation of percutaneous aortic CoreValve(®) prostheses in patients requiring permanent pacemakers (40%-45% of these patients). The aim of our study was to detect if 2- or 3-dimensional echocardiographic variables could predict the appearance of atrioventricular conduction disorders. For this purpose, the relationship of the prosthesis with the interventricular septum was studied in 26 consecutive patients. Twelve patients (46.1%) developed atrioventricular conduction disorders. A prosthetic penetration >12 mm in the left ventricular outflow tract and a contact surface >90% between the interventricular septum and the stent of the prosthesis in diastole were strongly associated with the appearance of conduction disturbances (87.5%; P=.034). The percentage of the prosthetic stent in contact with the interventricular septum in end diastole was the only independent predictor of atrioventricular conduction disorders (odds ratio=1.12; 95% confidence interval, 1.01-1.25; P=.03). The results suggest that a higher implantation of the prosthesis and a reduced stent length might decrease the incidence of this complication.

Acute left ventricle diastolic function improvement after transcatheter aortic valve implantation.

AIMS: Data regarding the effects of TAVI on LV after are scarce and conflicting results have been reported immediately after aortic valvuloplasty. This study aimed to determine the acute haemodynamic effects of transcatheter aortic valve implantation (TAVI) in left ventricle (LV) diastolic performance, immediately after aortic valvuloplasty and prosthesis deployment. METHODS AND RESULTS: Sixty-one patients with severe aortic valve stenosis, and preserved LV systolic function submitted to successful TAVI, were included. All procedures were guided through transoesophageal echocardiography, and parameters of diastolic function were evaluated before and minutes after TAVI. The mean age was 83.5±6 years and mean log EuroSCORE was 18.2±9.4. Before the procedure, all patients presented LV diastolic dysfunction. Immediately after TAVI, fewer patients presented a restrictive pattern [27 (44.3%), before the procedure, vs. 20 (34.4%), after TAVI (P=0.047)], and an increase in E wave deceleration time (211.2±75.5 vs. 252.7±102.3 cm/s, P=0.001), in E wave velocity (109.5±41.2 vs. 120.3±43.6 cm/s, P=0.025), and in isovolumetric relaxation time (83±36.5 vs. 97.1±36.0 ms, P=0.013) was observed. On multivariate analysis of covariance (ANCOVA), adjusting to LV systolic function, heart rate, blood pressure, and haematocrit values, the results remained significant. Patients referred to percutaneous approach had invasive haemodynamic data collected, showing a decrease in LV end-diastolic pressure after valve implantation [18.8±5.7 vs. 14.7±4.7, mean difference -4.1 (95% CI: -5.9; -2.9)]. Patients with a restrictive pattern immediately after TAVI presented a smaller decrease in LV end diastolic pressure (-3.3±4.7) than those with diastolic dysfunction grade I or II (-9.5±4.7; P=0.017). CONCLUSION: This is the first study describing LV diastolic performance during TAVI. Our results show improvement in diastolic function parameters in patients with preserved LV systolic function, immediately after successful TAVI.

Findings of a mixed transfemoral aortic valve implantation program using Edwards and CoreValve devices.

INTRODUCTION AND OBJECTIVES: Transfemoral implantation of an Edwards SAPIEN (ES) or Medtronic CoreValve (MCV) aortic valve prosthesis is an alternative to surgical replacement for patients with severe aortic stenosis and a high surgical risk. The study's aim was to compare results obtained with these two devices. METHODS: Prospective observational study of transfemoral prosthesis implantation performed at our center. RESULTS: Of the 76 patients (age 83 ± 6 years, 63% female, logistic EuroSCORE 18 ± 9) included, 50 were assigned the ES and 26 the MCV device. There was no difference between the groups in age, sex, functional class, valve area, associated conditions, or EuroSCORE. Implantation was successful in 84% of the ES group and 100% of the MCV group (P = .04). There were three cases of tamponade, two aortic dissections and one valve malposition in the ES group. The two groups had similar vascular access complication rates (26% vs. 23%; P=NS), but pacemaker need was greater with the MCV (10% vs. 39%; P = .003). Mortality rates at 30 days were 12% and 20% (P = NS) in the ES and MCV groups, respectively, and at 1 year, 24% and 20% (P = NS), respectively. After a follow-up of 367 ± 266 days in the ES group and 172 ± 159 days in the MCV group, three patients died. Clinical improvement was maintained in other patients and no echocardiographic changes were observed. CONCLUSIONS: In-hospital mortality, the complication rate and medium-term outcomes were similar with the two devices. The only difference observed was a higher implantation success rate with the MCV, although at the expense of a greater frequency of atrioventricular block.

Diagnosis and treatment of coronary stent entanglement complicated by extreme stent distortion.

A 2.5 x 32 mm Taxus Libert e stent was deployed at high pressure in the proximal right coronary artery (RCA) of a 71-year-old male patient, but the distal part of the lesion remained uncovered. A second stent (Driver 2.5 x 12 mm) could not be advanced through the first one and was withdrawn. The pullback traction resulted in dislodgement of the stent from its delivery balloon. Fluoroscopic examination suggested that the missing stent had traveled to the ascending aorta. Transesophageal echocardiography disclosed a dense, linear, mobile structure in the ascending aorta arising from the right coronary ostium. A 64-multislice computed tomographic scan revealed that both stents were entangled, with the first stent (Taxus 32 mm) elongated (approximately 90 mm in length), and the second one (Driver 12 mm) attached to the tail of the Taxus stent in the aorta. Stent retrieval was performed with a 15 mm snare loop catheter through a 7 Fr femoral sheath. Examination of the retrieved material revealed elongation of the Taxus stent entangled with the Driver stent. This case illustrates the potential for serious complications derived from stent entanglement, even with modern stent platforms, and how integrating noninvasive imaging modalities can provide crucial information regarding the cause of the complication and its solution.

Real-time three-dimensional echocardiography in aortic stenosis: a novel, simple, and reliable method to improve accuracy in area calculation.

AIMS: The aim of the study was to validate a novel formula for aortic area, based on the principle of continuity equation (CE), that substitutes Doppler-derived stroke volume (SV) by SV directly measured with real-time three-dimensional (RT3D) echo and semi-automated border detection. RT3D has proved outstanding accuracy for left ventricular volume calculation. So far, however, neither this potential has been applied to haemodynamic assessment, nor RT3D has succeeded in the evaluation of aortic valve disease. METHODS AND RESULTS: Aortic area was measured in 41 patients with aortic stenosis using Gorlin's equation, Hakki's formula, Doppler CE, two-dimensional Simpson's volumetric method, and by the novel RT3D method. RT3D has the best linear association and absolute agreement with Gorlin of all non-invasive methods r = 0.902, intraclass correlation coefficient (ICC) = 0.846, better than CE (r = 0.646, ICC = 0.626) and two-dimensional volumetric method (r = 0.627, ICC = 0.378). Linear and Passing-Bablok regression show that RT3D fits better to Gorlin (r(2) = 0.814) than CE (r(2) = 0.417) and two-dimensional method (r(2) = 0.393). Its accuracy is comparable to Hakki's formula, routinely employed in catheter laboratories. Inter- and intraobserver agreements (ICC) were, respectively, 0.732 and 0.985, better than CE (0.662, 0.857). RT3D also grades most efficiently the severity of aortic stenosis as mild, moderate, or severe (weighted kappa = 0.932). RT3D underestimates aortic area (95% CI 0.084-0.193). ROC curves, however, show that the optimal cutoff point to consider aortic stenosis severity remains close to 1 cm(2) (1.06 cm(2)). CONCLUSIONS: RT3D is more accurate than CE and than two-dimensional volumetric methods to calculate area and to grade the severity of aortic stenosis. Area obtained by three-dimensional echo is slightly underestimated, but its range is clinically negligible.

[Myocardial infarction with ST segment elevation and angiographically normal coronary arteries: epidemiology and mid-term follow-up]. / Infarto de miocardio con elevación del segmento ST y arterias coronarias angiográficamente normales: epidemiología y evolución a medio plazo.

BACKGROUND AND OBJECTIVE: The myocardial infarction (MI) with ST elevation and angiographically normal coronary arteries isn't frequent. The aim of this study is to describe clinical characteristic and mid-term follow-up of those patients. PATIENTS AND METHOD: Between January 1997 and December 2004 we identified 75 patients with MI and normal coronary arteries in a coronary angiography performed within one month of the AMI. All had criteria of MI and their coronary arteries were smooth and without obstructive lesions. RESULTS: The incidence was 3%, and mean age (standard deviation): 49 (11) years; 63% of patients were males and 47% were smokers, 33% had hypertension, 24% dislipemia and 9% diabetes. No patient had previous angina. MI location was anterior in 43%, inferior in 40% and lateral in 17%. The peak of creatine phosphokinase was 700 U/dl (range: 431-1,115) and the ejection fraction was 65% (14%). After a medium follow up of 30 months (range: 12-84) the events were: one death and 2 new MI. CONCLUSIONS: MI with normal coronary arteries is rare, is associated with a relative low rate of coronary risk factors, and with a good initial outcome, low rate of recurrent events and preservation of left ventricular function.

[Interventional cardiology 2006]. / Cardiología intervencionista 2006.

The range of applications of percutaneous coronary intervention (PCI) continues to expand and a growing number of patients are being treated, including those with extensive cardiovascular disease, more serious comorbid conditions, and more complex lesions. Even so, the success rate is high, serious complications are rare in stable patients, and the restenosis rate has been dramatically reduced by drug-eluting stents. Nevertheless, percutaneous techniques still have major limitations restricting their use in some type of lesions, such as bifurcations and total occlusions, and their role in relation to surgical revascularization has not yet been well defined in the treatment of the left main coronary artery or multivessel disease. The development of novel types of coated stent with better mechanical characteristics and a lower risk of occlusion will further expand the ambit of PCI. The role of PCI in the management of acute coronary syndromes is already well defined, and has increased the preference for an invasive rather than a conservative approach in high-risk patients without ST elevation and the preference for primary angioplasty rather than thrombolysis in those with ST elevation. The development and implementation of integrated coronary syndrome treatment networks will enable human and material resources to be used efficiently, and will guarantee rapid access to high-quality PCI for those who need it. The potential usefulness of combining cellular therapy with interventional procedures in the treatment of acute myocardial infarction has still to be determined. At present, there is extensive research into noncoronary interventions, which, in the not too distant future, could provide percutaneous treatment for the many elderly patients with severe aortic stenosis who are not currently eligible for surgery.