Updated clinical indications for transcatheter aortic valve implantation in patients with severe aortic stenosis: expert opinion of the Italian Society of Cardiology and GISE.

: The introduction of percutaneous treatment of severe aortic stenosis with transcatheter aortic valve implantation (TAVI) remains one of the greatest achievements of interventional cardiology. In fact, TAVI emerged as a better option than either medical therapy or balloon aortic valvuloplasty for patients who cannot undergo surgical aortic valve replacement (SAVR) or are at high surgical risk. Recently, increased operator experience and improved device systems have led to a worldwide trend toward the extension of TAVI to low-risk or intermediate-risk patients. In this expert opinion paper, we first discuss the basic pathophysiology of aortic stenosis in different settings then the key results of recent clinical investigations on TAVI in intermediate-risk aortic stenosis patients are summarized. Particular emphasis is placed on the results of the nordic aortic valve intervention, placement of aortic transcatheter valves (PARTNER) 2 and Surgical Replacement and Transcatheter Aortic Valve Implantation Randomized trials. The PARTNER 2 was the first large randomized trial that evaluated the outcome of TAVI in patients at intermediate risk. The PARTNER 2 data demonstrated that TAVI is a feasible and reasonable alternative to surgery in intermediate-risk patients (Society of Thoracic Surgeons 4-8%), especially if they are elderly or frail. There was a significant interaction between TAVI approach and mortality, with transfemoral TAVI showing superiority over SAVR. Moreover, we examine the complementary results of the recently concluded Surgical Replacement and Transcatheter Aortic Valve Implantation trial. This prospective randomized trial demonstrated that TAVI is comparable with surgery (primary end point 12.6% in the TAVI group vs. 14.0% in the SAVR group) in severe aortic stenosis patients deemed to be at intermediate risk. We review the most relevant clinical evidence deriving from nonrandomized studies and meta-analyses. Altogether, clinical outcome available data suggest that TAVI with a newer generation device might be the preferred treatment option in this patient subgroup. Finally, the differences between the latest European and American Guidelines on TAVI were reported and discussed. The conclusion of this expert opinion article is that TAVI, if feasible, is the treatment of choice in patients with prohibitive or high surgical risk and may lead to similar or lower early and midterm mortality rates compared with SAVR in intermediate-risk patients with severe aortic stenosis.

Mitral Effective Regurgitant Orifice Area Predicts Pulmonary Artery Pressure Level in Patients with Aortic Valve Stenosis.

BACKGROUND: Mitral regurgitation (MR) and elevated pulmonary artery pressure are common findings in patients with aortic valve stenosis (AS). The pathophysiologic role of quantitatively defined MR as a determinant of pulmonary hypertension (PH) is incompletely characterized across the whole spectrum of AS degrees. The purpose of the study was to investigate whether the quantification of MR reveals a link to PH in patients with AS. METHODS: Consecutive patients undergoing comprehensive echocardiography and presenting peak aortic velocity ≥ 2.5 m/sec were prospectively enrolled. Effective regurgitant orifice area (ERO) and regurgitant volume were obtained using the proximal isovelocity surface area method. Systolic pulmonary artery pressure was calculated by adding right atrial pressure to the tricuspid regurgitation pressure gradient. RESULTS: A total of 642 patients were enrolled between 2008 and 2013 (mean age, 79 ± 11 years; mean ejection fraction, 62 ± 10%; mean aortic valve area, 1.09 ± 0.39 cm2); MR was present in 187 (29%). Of note, 154 of 187 patients (82%) showed ERO < 0.20 cm2. ERO and regurgitant volume had the most significant associations with systolic pulmonary artery pressure (R2 = 0.30 and R2 = 0.35, respectively, P < .0001). This relationship persisted after multivariate adjustment and in the subgroups of patients with severe AS or reduced ejection fraction (P < .0001). For each 0.10-cm2 increase, the odds ratio for PH was 3.56 (95% CI, 2.65-4.86; P < .0001). CONCLUSIONS: In patients with MR and a wide range of AS severity, ERO is independently associated with PH. Also, the role of MR quantification appears stronger than other continuous variables commonly associated with left ventricular diastolic dysfunction, such as E/e' ratio and left atrial volume.

Redo procedures and chronic renal dysfunction are associated with higher risk of cardiac electronic device infections.

BACKGROUND: Infection is a major complication of pacemaker (PM) and implantable cardioverter-defibrillator (ICD) implantation. The present study sought to analyze the incidence rate of device infections, to investigate possible relationships between first implantations/repeated procedures and infection rates, and to identify some main risk factors associated with infection of cardiac implantable electronic devices (CIED). METHODS: In a single center retrospective observational study, records of 3899 consecutive patients having undergone PM and ICD implantation, cardiac resynchronization therapy (CRT) or revision (device/lead replacements or upgrades) and between 2002 and 2012 were obtained. RESULTS: Over a mean follow-up period of 66±14 months, a total of 50 patients were identified as having CIED infection (0.85% per procedure and 1.28% per patient). Chronic renal dysfunction and repeated procedures were independently associated with higher risk of CIED infection on multivariate analysis (respectively, OR 1.30, 95% CI: 1.16-1.57, P<0.0001; OR 1.23, 95% CI: 1.12-1.42, P<0.0001). Staphylococcal species was responsible for the bulk of CIED infections (70% of all positive cultures). Coagulase-negative staphylococci were found more frequently than staphylococcus aureus (30% vs. 12%). CONCLUSIONS: The infection rate after cardiac electronic device procedures was low over the follow-up period. Repeated procedures and chronic renal dysfunction were associated with higher risk of CIED infection. Staphylococcal species were mainly responsible for device infections.

Concomitant mitral regurgitation and aortic stenosis: one step further to low-flow preserved ejection fraction aortic stenosis.

Aims: Patients with severe aortic stenosis (AS) and normal ejection fraction (EF) can paradoxically present low-transaortic flow and worse prognosis. The role of co-existing mitral regurgitation (MR) in determining this haemodynamic inconsistency has never been quantitatively explored. The hypothesis is that MR influences forward stroke volume and characterizes the low-flow AS pattern. Methods and results: Consecutive patients with indexed aortic valve area (AVA) ≤0.6 cm2/m2 and EF > 50% formed the study population. Complete echocardiographic data were collected, and mitral effective regurgitant orifice area (ERO) and regurgitant volume were obtained with proximal isovelocity surface area method. Patients were divided into subgroups according to indexed stroke volume (SV index). Included patients were 273 [age 79 ± 10 years, 53% female, EF 65 ± 7%, indexed AVA 0.47 ± 0.09 cm2/m2, mean transaortic gradient (MG) 32 ± 17 mmHg]. Mitral regurgitation was present in 89 (32%); ERO was 0.12 ± 0.08 cm2 (range 0.02-0.49 cm2). A low-flow state (SV index ≤35 mL/m2) was diagnosed in 41 (15%) patients. The prevalence of MR was higher in with low-flow vs. normal-flow group (56 vs. 28%, P = 0.03). Effective regurgitant orifice was associated to low-flow state univariately (OR: 1.75 [1.59-2.60]; P = 0.004) and after comprehensive adjustment (OR:1.76 [1.12-2.75]; P = 0.01). When MG was forced in the model, ERO remained significant (P < 0.009). On average, there was a 6 mL reduction in forward SV appeared per each 0.1 cm2 of ERO. Conclusion: In patients with severely reduced AVA and preserved EF, MR is a major determinant of the low-flow condition. Furthermore, MR quantification by ERO predicts the presence of reduced flow independently of chamber volumes, systolic function, and transaortic gradient.

Significant Drop in Right Atrial Pressure Does Not Influence Fractional Flow Reserve Coronary Assessment.

The effect of a highly elevated level of right atrial filling pressure on fractional flow reserve (FFR) measurement remains unclear. Transcatheter tricuspid valve intervention, a recently introduced option for inoperable or high-risk patients, represents a unique model of in-vivo physiology to investigate the eventual influence of central venous pressure on coronary FFR measurements. The case is reported of a patient with a degenerated tricuspid surgical bioprosthesis who underwent transcatheter tricuspid valve-in-valve replacement and concomitant coronary functional assessment with FFR. In an experimental model, the significant fall in right atrial pressure did not influence FFR measurements in the presence of angiographically proven mild coronary artery disease.

Atrial Function as an Independent Predictor of Postoperative Atrial Fibrillation in Patients Undergoing Aortic Valve Surgery for Severe Aortic Stenosis.

BACKGROUND: Postoperative atrial fibrillation (POAF) is a common, clinically relevant, but hardly predictable complication after surgical aortic valve replacement. The aim of this study was to test the role of preoperative left atrial longitudinal strain as a predictor of POAF in clinical practice. METHODS: Sixty patients scheduled for aortic valve replacement for severe isolated aortic stenosis, in stable sinus rhythm, were prospectively enrolled and underwent full clinical, biochemical, and transthoracic echocardiographic assessment on the day before surgery. Left atrial strain-derived peak atrial longitudinal strain (PALS) and peak atrial contraction strain (PACS) were obtained. The occurrence of POAF was evaluated during the hospital stay after the intervention. RESULTS: POAF was present in 26 of 60 patients (43.3%). Among all clinical variables examined, age showed a significant correlation with POAF (P = .04), while no significant differences were noted regarding preoperative symptoms, cardiovascular risk factors, medications, and biochemical data. As for the echocardiographic parameters, only PALS and PACS showed strong, significant correlations with the occurrence of arrhythmia (P < .0001 on univariate analysis), with areas under the curve of 0.87 ± 0.04 (95% CI, 0.76-0.94) for PALS and 0.85 ± 0.05 (95% CI, 0.73-0.93) for PACS. In two comprehensive multivariate models, PALS and PACS remained significant predictors of POAF (odds ratio, 0.73 [95% CI, 0.61-0.88; P = .0008] and 0.72 [95% CI, 0.59-0.87; P = .0007]). No significant interaction was detected between PALS or PACS and other clinical and echocardiographic variables, including age, E/E' ratio, and left atrial enlargement. CONCLUSIONS: PALS and PACS indexes are routinely feasible and useful to predict POAF in patients with severe isolated aortic stenosis undergoing surgical aortic valve replacement.

Clinical outcomes of secondary prevention strategies for young patients with cryptogenic stroke and patent foramen ovale.

Background The aim of this study was to compare the immediate and long-term clinical outcomes of medical therapy and percutaneous patent foramen ovale (PFO) closure as secondary prevention strategies in patients younger than 55 years of age presenting with cryptogenic stroke and PFO. Methods Between January 2006 and April 2015, all patients with the diagnosis of cryptogenic stroke and PFO were analysed and prospectively followed. Stroke was confirmed in 159 out of 309 patients (51%). In the remaining cases, other neurological conditions were found and therefore excluded from further analysis. Patients received PFO closure or medical therapy on the basis of a pre-specified algorithm. Primary outcome was the assessment of recurrent ischaemic events at follow-up. Results Percutaneous PFO closure was performed in 77 patients (48%) and 82 (52%) were treated medically. Mean follow-up was 51.6 ± 34.8 months. Two ischaemic strokes occurred in the medical group only (2.4% vs 0%; P = 0.16) and no complications related to the invasive procedure were observed. Conclusions The diagnosis of stroke in patients with PFO could be confirmed in 50% of cases only, underlining the importance of a multidisciplinary evaluation of these patients. A very low ischaemic recurrence rate was observed in the medical therapy group, suggesting that a personalized treatment based on a prespecified diagnostic algorithm yields good clinical results irrespective of the treatment modality. Given the low number of recurrences, larger cohorts may be needed to prove significant differences.

Coronary physiology in patients with severe aortic stenosis: Comparison between fractional flow reserve and instantaneous wave-free ratio.

BACKGROUND: The functional assessment of coronary artery disease (CAD) in patients with aortic stenosis (AS) has not been validated so far, and the best strategy to physiologically investigate the relevance of coronary stenosis in this specific setting of patients remains undetermined. The aim of the study is to compare the diagnostic performance of instantaneous wave-free ratio (iFR) and fractional flow reserve (FFR) in patients with severe AS. METHODS: The functional significance of 179 coronary lesions was investigated with on-line iFR and FFR measurements in 85 AS patients and compared with a control group formed by 167 patients (290 lesions) with stable CAD and without AS. The iFR-FFR diagnostic agreement has been tested using the conventional 0.80 FFR cut-off. RESULTS: The correlation between iFR and FFR was similar between AS and CAD patients, as well as the area under the curve at ROC curve analysis (0.97 vs 0.96, p=0.88). However, using the standard iFR 0.89 threshold, the diagnostic accuracy of iFR was significantly lower in AS compared with CAD (76.3% vs 86.1%, p=0.009). According to ROC analysis, the best iFR cut-off in predicting FFR≤0.8 was lower in AS (0.83, J=0.82) compared with CAD (0.89, J=0.81). Using the ROC derived cut-off of 0.83, the iFR accuracy increased significantly (91.3%, p=0.003) while maintaining an elevated negative predictive value (95.5%). CONCLUSIONS: In the presence of severe AS, conventional iFR cut-off had lower diagnostic agreement with FFR classification of coronary lesions compared to stable CAD patients. AS seems to influence iFR cut-off ischemic thresholds and deserves further comparative studies.

Feasibility and relevance of right parasternal view for assessing severity and rate of progression of aortic valve stenosis in primary care.

BACKGROUND: Right parasternal view (RPV) is important in assessing the severity of aortic stenosis (AS). However, the feasibility and relevance of RPV in primary care is unresolved. Moreover, information regarding the role of RPV in the evaluation of the hemodynamic progression of AS is lacking. METHODS: Consecutive patients with peak aortic valve velocity (Vmax) ≥2.5m/s were prospectively enrolled in a primary care echocardiographic laboratory. Aortic Doppler parameters were evaluated from apical view and RPV. RESULTS: The total number of enrolled patients was 330 (aged 81±11years, 47% female, left ventricular ejection fraction 64±9%). The RPV was feasible in 275 (83%). Vmax and Mean Gradient were significantly higher and aortic valve area was significantly lower from RPV as compared to apical view (p<0.0001 for all). Reclassification of severity towards either moderate or severe AS occurred in 13-26% of patients, according to different criteria, when evaluated from RPV. Among 108 patients (40%) undergoing multiple examinations the rate of progression was lower from the apical approach than from the RPV (0.19±0.20m/s/year vs. 0.24±0.27m/s/year, respectively; p=0.03), and was fast (>0.3m/s/year) in 17 patients (16%) from the apical window vs. 26 patients (24%) from RPV (p<0.0001). CONCLUSION: Implementing RPV is feasible in primary care and results in a substantial reclassification rate through the entire spectrum of AS severity. Our data also suggest a potential role of Doppler interrogation from multiple windows to improve AS progression assessment.

Pitfalls in electrogram interpretation: Subcutaneous cardioverter defibrillator malfunction in Brugada syndrome.

A patient with Brugada syndrome implanted with subcutaneous implantable cardioverter defibrillator (S-ICD) had oversensing episodes treated with S-ICD shocks. Comparable artifacts were not evocable with S-ICD pocket manipulation. The fluoroscopy excluded S-ICD macroscopic damage. The device extraction revealed undamaged pulse generator and connector, but the lead was inappropriately tunneled under the sixth rib. Then the S-ICD malfunction was due to lead microscopic damage caused by the lead rubbing the rib surface.

Long-term follow-up after trans-catheter tricuspid valve-in-valve replacement with balloon-expandable aortic valves.

BACKGROUND: Transcatheter tricuspid VIV replacement has been proposed as a feasible option for high-risk patients with previous tricuspid valve replacement that undergo valve degeneration causing refractory heart failure. However, little is known about the long-term outcome of patients treated with transcatheter tricuspid VIV. We evaluate the safety of transcatheter tricuspid valve-in-valve (VIV) replacement by using balloon-expandable aortic valve stents and the long-term follow-up. METHODS AND RESULTS: From January 2013 to March 2016, 4 patients underwent transcatheter tricuspid VIV in our center using balloon-expandable Edwards Sapien-XT and Sapien-3 valves. In all cases the procedure succeeded with significant improvement of the tricuspid valve area (from 0.98±0.29cm2 to 3.1±0.45cm2, p=0.005), right atrial pressure (from 21±7.78mmHg to 8.5±2.51mmHg, p=0.025) and mean trans-valvular gradient (from 11.5±4mmHg to 3.32±1.28mmHg, p=0.02). Three out of 4 patients presented a follow up longer than 2.5years. At median follow up of 32months (range 9-47months) all patients were alive and presented with NYHA class I-II. Only one patient, who presented impaired right ventricular function at baseline, experienced re-hospitalization during the follow-up time. Echocardiographic assessment at long-term disclosed a well-maintained hemodynamic performance with low trans-valvular gradients and no significant valvular regurgitation in all cases. CONCLUSIONS: In our experience, trans-catheter tricuspid VIV demonstrated good long-term results in terms of valve performance and functional class improvement at 32months from intervention.

Dyspnea following thoracostomy closure after right pneumonectomy: An uncommon echocardiographic diagnosis and therapeutic approach.

Dyspnea and hypoxemia are common postoperative problems after pneumonectomy. One of the rarer causes of respiratory distress after right pneumonectomy is the development of a significant right-to-left shunt across a patent foramen ovale (PFO), which can evolve at a variable interval of time after the operation. We report here our experience with a patient who underwent right pneumonectomy, followed by several complications, and who presented severe dyspnea 7 months later, after the closure of a right thoracostomy. This report outlines the management of this challenging clinical condition; transesophageal echocardiography (TOE) provided a clear diagnosis and guided an effective percutaneous treatment.

Left ventricular end-diastolic volume as early indicator of trastuzumab-related cardiotoxicity in HER2+ breast cancer patients: results from a single-center retrospective study.

BACKGROUND: Adjuvant trastuzumab therapy increases survival rates in patients with early HER2-positive breast cancer, although it can be potentially cardiotoxic. The aim of this study was to evaluate the prevalence of left ventricular (LV) systolic dysfunction; and the relationship between the presence of cardiovascular risk factors, cardiac therapy and/or echocardiographic parameters of systolic function at baseline and the development of cardiotoxicity in such patients. METHODS: A total of 227 patients were retrospectively reviewed. Cardiotoxicity was defined as a decrease in LV ejection fraction (EF) below 50% or an absolute decrease of >10 points below the baseline value or any indication of heart failure. Each patient underwent echocardiography at baseline and at follow-up every three months. RESULTS: The prevalence of cardiotoxicity was 17.6% (15.4% asymptomatic, 2.2% symptomatic). Patients developing LV dysfunction presented hypertension (P=0.041) and diabetes (P=0.01) and used cardiac therapy at baseline more frequently. Smoke habit, age >50 and use of angiotensin-converting enzyme (ACE)-inhibitors, were independent predictors of cardiac damage. Furthermore, patients with LV dysfunction showed baseline LV end-diastolic volume (EDV) higher than those who did not and baseline EDV (OR=1.02; 95% CI: 1.00-1.04; P=0.027) independently predicted cardiotoxicity with 58 mL/m2 as best cut-off point (AUC=0.65, 95% CI: 0.55-0.75]). CONCLUSIONS: The prevalence of trastuzumab-related cardiotoxicity in patients with HER2-positive early breast cancer is relatively frequent, although asymptomatic in most cases. Baseline EDV resulted as independent predictor of cardiotoxicity suggesting that EDV may be more reliable than LVEF to identify patients at higher risk of developing cardiac damage.

Mitral Regurgitation and Increased Risk of All-Cause and Cardiovascular Mortality in Patients with Type 2 Diabetes.

BACKGROUND: Mitral regurgitation is the most common heart valve disease in the general population, but little is known about the prevalence and prognostic implications of mitral regurgitation in patients with type 2 diabetes. METHODS: We retrospectively analyzed the data from 814 outpatients with type 2 diabetes who had undergone a conventional echocardiography for clinical reasons during the years 1992-2007. Mitral regurgitation was evaluated by using an integrated multiparametric echocardiographic approach. The study outcomes were all-cause and cardiovascular mortality. RESULTS: At baseline, 261 (32%) patients had mitral regurgitation (25% mild, 5% moderate, and 2% severe). Over a mean follow-up of 9 years, 120 (14%) patients died, 50 of them from cardiovascular causes. Compared with those without valve disease, patients with mild mitral regurgitation had a 3.3-fold increased risk of all-cause mortality, whereas those with moderate-to-severe mitral regurgitation had a 5.1-fold increased risk of all-cause mortality. Results remained statistically significant after adjustment for multiple potential confounders. Similar results were found for cardiovascular mortality. CONCLUSIONS: Mitral regurgitation is a common pathologic condition in patients with type 2 diabetes and is independently associated with an increased risk of both all-cause and cardiovascular mortality, even if the severity of mitral regurgitation is mild.

Coronary Catheterization and Percutaneous Interventions After Transcatheter Aortic Valve Implantation.

Coronary artery disease (CAD) is often present in patients with severe aortic valve stenosis candidates to transcatheter aortic valve implantation (TAVI). Mild CAD may also worsen and need treatment years after TAVI. The implantation of a transcatheter valve may interfere with the capability of reengaging the coronary arteries. We prospectively assessed the feasibility of performing coronary angiography (CA), fractional flow reserve, and, where indicated, percutaneous coronary intervention after valve implantation in a consecutive series of patients with CAD undergoing TAVI. Valve type and size were decided according to accurate computed tomography scan and angiographic measurement of the aortic root structures. We analyzed 66 consecutive patients undergoing TAVI, 41 with balloon-expandable, and 25 with self-expandable transcatheter valves. Right and left coronary catheterization (132 vessels) was successful in all cases except in 1 left coronary artery after a high implantation of a self-expandable valve (unsuccess rate, 1 in 50 vessels). In 6 of 132 vessels (4%), CA was initially nonselective, but after positioning the 0.014″ intracoronary guidewire, selective injections were obtained in all these cases. Percutaneous coronary intervention was performed successfully in 19 coronary vessels (17 patients) as indicated by fractional flow reserve measurements. In conclusion, catheterization of the coronary ostia after transfemoral TAVI with balloon or self-expandable valves is safe and feasible in almost all cases. Accurate imaging of the aortic root and procedural planning may help to avoid too high implantation of supra-annular self-expandable valves to obviate difficulties in accessing coronary ostia. Use of intracoronary guidewires facilitates selective CA in cases with difficult access.

Functional Assessment of Coronary Artery Disease in Patients Undergoing Transcatheter Aortic Valve Implantation: Influence of Pressure Overload on the Evaluation of Lesions Severity.

BACKGROUND: Aortic valve stenosis may influence fractional flow reserve (FFR) of concomitant coronary artery disease by causing hypertrophy and reducing the vasodilatory reserve of the coronary circulation. We sought to investigate whether FFR values might change after valve replacement. METHODS AND RESULTS: The functional relevance of 133 coronary lesions was assessed by FFR in 54 patients with severe aortic valve stenosis before and after transcatheter aortic valve implantation (TAVI) during the same procedure. A linear mixed model was used to verify the interaction of TAVI effect with the FFR values. No significant overall change in FFR values was found before and after the aortic valve stenosis removal (0.89±0.10 versus 0.89±0.13; P=0.73). A different trend in FFR groups (positive if ≤0.8; negative if >0.8) was found after TAVI (P for interaction <0.001). Positive FFR values worsened after TAVI (0.71±0.11 versus 0.66±0.14). Conversely, negative FFR values improved after TAVI (0.92±0.06 versus 0.93±0.07). Similarly, FFR values in coronary arteries with lesions presenting percent diameter stenosis >50 worsened after TAVI (0.84±0.12 versus 0.82±0.16; P=0.02), whereas FFR values in arteries with mild lesions (percent diameter stenosis <50) tended toward improvement after TAVI (0.90±0.07 versus 0.91±0.09; P=0.69). Functional FFR variations after TAVI changed the indication to treat the coronary stenosis in 8 of 133 (6%) lesions. CONCLUSIONS: Coronary hemodynamics are influenced by aortic valve stenosis removal. Nevertheless, FFR variations after TAVI are minor and crossed the diagnostic cutoff of 0.8 in a small number of patients after valve replacement. Borderline coronary lesions might become functionally significant after valve replacement, although FFR-guided interventions were infrequent even in patients with angiographically significant lesions.

Clinical outcomes of transcatheter aortic valve implantation: from learning curve to proficiency.

OBJECTIVE: The use of transcatheter aortic valve implantation (TAVI) is growing rapidly in countries with a predominantly elderly population, posing a huge challenge to healthcare systems worldwide. The increment of human and economic resource consumption imposes a careful monitoring of clinical outcomes and cost-benefit balance, and this article is aimed at analysing clinical outcomes related to the TAVI learning curve. METHODS: Outcomes of 177 consecutive transfemoral TAVI procedures performed in 5 years by a single team were analysed by the Cumulative Sum of failures method (CUSUM) according to the clinical events comprised in the Valve Academic Research Consortium (VARC-2) safety end point and the VARC-2 definition of device success. Margins for events acceptance were extrapolated from landmark trials that tested both balloon or self-expandable percutaneous valves. RESULTS: 30-day and 1-year survival rates were 97.2% and 89.9%, respectively. Achievement of the primary end point (number of cases needed to provide the acceptable margin of the composite end point of any death, stroke, myocardial infarction, life-threatening bleeding, major vascular complications, stage 2-3 acute kidney injury and valve-related dysfunction requiring a repeat procedure) required the performance of 54 cases, while the learning curve to achieve 'device success' identified 32 cases to reach the expected proficiency. In this experience, the baseline clinical risk as assessed by the Society of Thoracic Surgeons (STS) score determined the long-term survival rather than the adverse events related to the learning curve. CONCLUSIONS: A relatively large number of cases are required to achieve clinical outcomes comparable to those reported in high-volume centres and controlled trials. According to our national workload standards, this represents more than 2 years of continuous activity.

Functional mitral regurgitation: are we treating the real target?

Functional mitral regurgitation is a form of valve insufficiency in the presence of anatomically normal mitral valve. The cause of functional mitral regurgitation is left ventricular remodelling that tethers valve leaflet more apically decreasing their coaptation ability. Given the pathophysiologic relation between functional mitral regurgitation and ventricular dysfunction, the valve insufficiency has long been considered a surrogate of ventricular disease. Accordingly, all potential therapeutic strategies able to decrease functional mitral regurgitation have been associated with improved ventricular function. On the contrary, the surgical treatment of functional mitral regurgitation has led to contrasting results, but the main drawback is that it does not improve survival compared with medical therapy. However, surgery is characterized by many confounding factors, which might conceal the beneficial effect of the treatment of valve dysfunction in the mid-long-term follow-up. The present review underscores the potential limits of surgical treatment and hypothesized that percutaneous treatment of functional mitral regurgitation, by means of MitraClip, Abbott, Menlo Park, California, might represent a better tool to investigate treatment of functional mitral regurgitation.

Echocardiographically Derived Pulse Wave Velocity and Diastolic Dysfunction Are Associated with an Increased Incidence of Atrial Fibrillation in Patients with Systolic Heart Failure.

BACKGROUND: Chronic heart failure (CHF) is an established risk factor of atrial fibrillation (AF), but the prognostic value of cardiac and hemodynamic parameters in assessing the risk of developing AF among patients with CHF is less defined. METHODS AND RESULTS: We followed an outpatients cohort of CHF patients secondary to left ventricular (LV) systolic dysfunction, who were free of AF at baseline. All patients underwent clinical evaluation, comprehensive echocardiography, and blood drawing in the same morning. Aortic pulse wave velocity (aPWV), a measure of aortic stiffness, was determined by Doppler echocardiography. A total of 77 patients (age 63 ± 9 years; 79% male) with mean LVEF (34 ± 8%) formed the study population. Fifteen patients developed incidental AF. At baseline, CHF patients who developed AF during follow-up had higher E-wave velocity (75 ± 2 cm/sec vs. 60 ± 2 cm/sec; P = 0.02), higher difference duration between mitral and pulmonary vein A velocity (A'-A), (10 ± 35 msec vs. 43 ± 44 msec P = 0.02), aPWV (7.1 ± 2.6 vs. 5.3 ± 1.9 m/sec P = 0.004), and furosemide dosage (110 ± 145 mg vs. 49 ± 48 mg P = 0.01) than those remaining free from AF. The two groups of patients did not significantly differ in terms of NYHA, LV volumes, ejection fraction, left atrial volume, creatinine, hemoglobin, renin, epinephrine, amino-terminal propeptide of type III and I procollagens, ACE inhibitor, and ß-blocker dose (P > 0.1 for all). Notably, higher aPWV (P = 0.01) and longer A-A' duration (P = 0.04) were associated with an increased incidence of AF, independently of potential confounders. CONCLUSIONS: Increased aortic stiffness and LV diastolic dysfunction are strong predictors of new onset of AF among patients with systolic CHF.