Left Ventricular Filling Pressure in Chronic Thromboembolic Pulmonary Hypertension.

BACKGROUND: Chronic thromboembolic pulmonary hypertension (CTEPH) is characterized by obstruction of major pulmonary arteries with organized thrombi. Clinical risk factors for pulmonary hypertension due to left heart disease including metabolic syndrome, left-sided valvular heart disease, and ischemic heart disease are common in CTEPH patients. OBJECTIVES: The authors sought to investigate prevalence and prognostic implications of elevated left ventricular filling pressures (LVFP) in CTEPH. METHODS: A total of 593 consecutive CTEPH patients undergoing a first diagnostic right and left heart catheterization were included in this study. Mean pulmonary arterial wedge pressure (mPAWP) and left ventricular end-diastolic pressure (LVEDP) were utilized for assessment of LVFP. Two cutoffs were applied to identify patients with elevated LVFP: 1) for the primary analysis mPAWP and/or LVEDP >15 mm Hg, as recommended by the current pulmonary hypertension guidelines; and 2) for the secondary analysis mPAWP and/or LVEDP >11 mm Hg, representing the upper limit of normal. Clinical and echocardiographic features, and long-term mortality were assessed. RESULTS: LVFP was >15 mm Hg in 63 (10.6%) and >11 mm Hg in 222 patients (37.4%). Univariable logistic regression analysis identified age, systemic hypertension, diabetes, atrial fibrillation, calcific aortic valve stenosis, mitral regurgitation, and left atrial volume as significant predictors of elevated LVFP. Atrial fibrillation, calcific aortic valve stenosis, mitral regurgitation, and left atrial volume remained independent determinants of LVFP in adjusted analysis. At follow-up, higher LVFPs were measured in patients who had meanwhile undergone pulmonary endarterectomy (P = 0.002). LVFP >15 mm Hg (P = 0.021) and >11 mm Hg (P = 0.006) were both associated with worse long-term survival. CONCLUSIONS: Elevated LVFP is common, appears to be due to comorbid left heart disease, and predicts prognosis in CTEPH.

Pulmonary artery to ascending aorta ratio by echocardiography: A strong predictor for presence and severity of pulmonary hypertension.

BACKGROUND: The pulmonary artery (PA) to ascending aorta diameter ratio (PA:A) has been evaluated in numerous studies analyzing cardiac magnetic resonance (CMR) and computed tomography (CT) data. Previously, no transthoracic echocardiography (TTE) cutoffs have been published. We sought to evaluate (1) the feasibility to image the pulmonary trunk in a prospective cohort, and (2) the ability of PA:A derived by TTE to predict pulmonary hypertension (PH). METHODS: We performed a post-hoc analysis of a prospectively recruited consecutive cohort of patients referred to our tertiary center cardiology department due to suspicion for PH. Invasive hemodynamic assessment and quasi-simultaneous TTE was performed in all participants. RESULTS: A total of 84 patients were included in the analysis, median age was 70.5 years (IQR 58-75), 46 (55%) were female. The PA was significantly wider in the PH group (28mm vs. 22.5mm, p<0.001) with a resulting median PA:A of 0.84 vs. 0.66 (p<0.001). Both PA diameter (r = 0.524 and r = 0.44, both p<0.001) and PA:A (r = 0.652 and 0.697, both p<0.001) significantly correlated with mPAP and with PVR, respectively. Area under the curve for the detection of PH was 0.853 (95%CI 0.739-0.967, p<0.001). CONCLUSION: The PA can be visualized in almost all echocardiographic exams, especially when it is dilated. A view showing the pulmonary trunk should be included in every routine TTE. An increased PA:A should raise suspicion for PH and prompt further evaluation and follow-up examinations of these patients.

Echocardiographic evaluation of left ventricular filling pressures in patients with pulmonary hypertension.

Echocardiographic assessment of diastolic dysfunction depends on surrogate parameters. In recent years, guideline committees attempted to combine these parameters to diagnostic flowcharts allowing for correct classification of left ventricular filling pressures (LVFP). The value of these diagnostic tools is limited if the applied surrogate parameters are elevated due to other reasons as is the case with maximal tricuspid regurgitation velocity. We aimed to compare the accuracy of the 2009 and the 2016 guideline recommendations in patients with pulmonary hypertension (PH). We included 101 consecutive patients who underwent right heart catheterization and transthoracic echocardiography for suspicion of PH. For the final analysis, only patients with PH were considered. The 2009 and 2016 recommendations for the assessment of diastolic function by echocardiography were applied on each patient. A total of 63 PH patients were included in the final analysis, 43% had elevated LVFP. By using the 2009 recommendations, sensitivity for correct classification of diastolic dysfunction was 67%, specificity was 82%, area under the curve (AUC) was 0.74. By using the 2016 recommendations, sensitivity for correct classification of diastolic dysfunction was 84%, specificity was 80%, AUC was 0.82. In ROC comparison, the AUC for the 2016 recommendations with 0.82 was significantly better compared to the AUC of 0.74 for the 2009 recommendations (p = 0.04). Our study demonstrates that the 2016 recommendations for echocardiographic evaluation of diastolic function are superior to the 2009 recommendations in estimating left ventricular filling pressures in patients with PH.

In-depth haemodynamic phenotyping of pulmonary hypertension due to left heart disease.

The commonest cause of pulmonary hypertension (PH) is left heart disease (LHD). The current classification system for definitions of PH-LHD is under review. We therefore performed prospective in-depth invasive haemodynamic phenotyping in order to assess the site of increased pulmonary vascular resistance (PVR) in PH-LHD subsets.Based on pulmonary artery occlusion waveforms yielding an estimate of the effective capillary pressure, we partitioned PVR in larger arterial (Rup, upstream resistance) and small arterial plus venous components (Rds, downstream resistance). In the case of small vessel disease, Rup decreases and Rds increases. Inhaled nitric oxide (NO) testing was used to assess acute vasoreactivity.Right ventricular afterload (PVR, pulmonary arterial compliance and effective arterial elastance) was significantly higher in combined post- and pre-capillary PH (Cpc-PH, n=35) than in isolated post-capillary PH (Ipc-PH, n=20). Right ventricular afterload decreased during inhalation of NO in Cpc-PH and idiopathic pulmonary arterial hypertension (n=31), but remained unchanged in Ipc-PH. Rup was similar in Cpc-PH (66.8±10.8%) and idiopathic pulmonary arterial hypertension (65.0±12.2%; p=0.530) suggesting small vessel disease, but significantly higher in Ipc-PH (96.5±4.5%; p<0.001) suggesting upstream transmission of elevated left atrial pressure.Right ventricular afterload is driven by elevated left atrial pressure in Ipc-PH and is further increased by elevated small vessel resistance in Cpc-PH. Cpc-PH is responsive to inhaled NO. Our data support current definitions of PH-LHD subsets.

Multi-view approach for the diagnosis of pulmonary hypertension using transthoracic echocardiography.

Pulmonary hypertension (PH) is a disease with severe morbidity and mortality. Echocardiography plays an essential role in the screening of PH. The quality of the acquired continuous wave Doppler signal is the major limitation of the method and can greatly affect the accuracy of estimated pulmonary pressures. The aim of this study was to evaluate the clinical need to image from multiple ultrasound windows in patients with suspected pulmonary hypertension. We prospectively evaluated 65 patients (43% male, mean age 67.2 years) with echocardiography and right heart catheterization. 17% had invasively normal pulmonary pressures, 83% had pulmonary hypertension. Peak tricuspid regurgitation (TR) velocity was imaged in five echocardiographic views. Sufficient Doppler signal was recorded in 94% of the patients. Correlation for overall peak TR velocity with invasively measured systolic pulmonary artery pressure was r = 0.83 (p < 0.001). Considering all five imaging windows resulted in a sensitivity of 87%, and a specificity of 91% for correct diagnosis of PH with an AUC of 0.89, which was significantly better as compared to sole imaging from the right ventricular modified apical four-chamber view (AUC 0.85, p = 0.0395). Additional imaging from atypical views changed the overall peak TR velocity in 32% of the patients. A multiple-view approach changed the echocardiographic diagnosis of PH in 11% of the patients as opposed to sole imaging from an apical four-chamber view. This study comprehensively assessed the impact on clinical decision making when evaluating patients with an echocardiographic multiplane approach for suspected PH. This approach substantially increased sensitivity without a decrease in specificity.

The Ultimaster Biodegradable-Polymer Sirolimus-Eluting Stent: An Updated Review of Clinical Evidence.

The Ultimaster coronary stent system (Terumo Corporation, Tokyo, Japan) represents a new iteration in drug-eluting stent (DES) technology that has recently received the Conformité Européenne (CE) mark approval for clinical use. The Ultimaster is a thin-strut, cobalt chromium, biodegradable-polymer, sirolimus-eluting coronary stent. The high elasticity of the biodegradable-polymer (PDLLA-PCL) and the abluminal gradient coating technology are additional novel features of this coronary device. The Ultimaster DES has undergone extensive clinical evaluation in two studies: The CENTURY I and II trials. Results from these two landmark studies suggested an excellent efficacy and safety profile of the Ultimaster DES across several lesion and patient subsets, with similar clinical outcomes to contemporary, new-generation DES. The aim of this review is to summarize the rationale behind this novel DES technology and to provide an update of available evidence about the clinical performance of the Ultimaster DES.

Early results of MitraClip system implantation by real-time three-dimensional speckle-tracking left ventricle analysis.

AIMS: To appraise the early effect of percutaneous mitral valve repair with the MitraClip system on myocardial function using real-time three-dimensional speckle-tracking echocardiography (3D-STE). METHODS: Consecutive patients with moderate-to-severe or severe mitral regurgitation, undergoing mitral valve repair with the MitraClip system, were prospectively evaluated during the peri-procedural workout and follow-up. Left ventricular deformation was evaluated by a two-dimensional and 3D speckle-tracking analysis. 3D-STE acquisitions were elaborated obtaining real-time 3D global longitudinal strain evaluation, and by appraising both volumetric and hemodynamic parameters (i.e. left ventricular end-diastolic volume, left ventricular end-systolic volume, left ventricular ejection fraction, cardiac output, and stroke volume). RESULTS: In all, 30 patients were included. At 1-month follow-up, 3D-STE analysis revealed no changes in left ventricular end-diastolic volume (162.6 ±â€Š73.7 ml at baseline vs. 159.8 ±â€Š64.5 ml at 1-month follow-up; P = 0.63) and a downward trend in left ventricular end-systolic volume (104.7 ±â€Š52.0 vs. 100.1 ±â€Š50.4 ml, respectively; P = 0.06). Left ventricular ejection fraction did not significantly increase (38.1 ±â€Š11.3% at baseline vs. 39.4 ±â€Š11.0% at 1-month follow-up; P = 0.20). No significant changes were reported in cardiac output (4.3 ±â€Š2.0 l/min at baseline vs. 4.0 ±â€Š1.5 l/min at follow-up; P = 0.377) and in stroke volume (59.5 ±â€Š25.5 ml at baseline vs. 59.9 ±â€Š20.7 ml at follow-up; P = 0.867). On the contrary, left ventricular deformation capability significantly improved, with the real-time 3D global longitudinal strain value changing from -9.8 ±â€Š4.1% at baseline to -11.0 ±â€Š4.4% at follow-up (P = 0.018). CONCLUSIONS: Accurately assessing myocardial function by the use of 3D-STE, this study reported irrelevant early changes in left ventricular size, but a positive effect on left ventricular deformation capability following mitral valve repair with the MitraClip system. These preliminary results need to be confirmed in larger series and extended to long-term follow-up.

Pulmonary Hypertension in Heart Failure. Epidemiology, Right Ventricular Function, and Survival.

RATIONALE: Patients with pulmonary hypertension due to left heart disease (PH-LHD) and a diastolic pulmonary vascular pressure gradient ≥ 7 mm Hg, representing PH out of proportion to pulmonary arterial wedge pressure, have pulmonary vascular disease and increased mortality. Little information exists on this condition, recently labeled as "combined pre- and post-capillary PH" (Cpc-PH). OBJECTIVES: To investigate epidemiology, risk factors, right ventricular function, and outcomes in patients with chronic heart failure and Cpc-PH. METHODS: The study population was identified from a retrospective chart review of a clinical database of 3,107 stable patients who underwent first diagnostic right heart catheterization and from a prospective cohort of 800 consecutive patients at a national university-affiliated tertiary center. MEASUREMENTS AND MAIN RESULTS: The retrospective cohort had 664 patients with systolic heart failure (SHF) and 399 patients with diastolic heart failure (DHF), 12% of whom were classified as Cpc-PH. The prospective cohort had 172 patients with SHF (14% Cpc-PH) and 219 patients with DHF (12% Cpc-PH). Chronic obstructive pulmonary disease (P = 0.034) and the tricuspid annular plane systolic excursion to systolic pulmonary artery pressure ratio (P = 0.015) predicted Cpc-PH in SHF. Younger age (P = 0.004), valvular heart disease (P = 0.046), and the tricuspid annular plane systolic excursion to systolic pulmonary artery pressure ratio predicted Cpc-PH in DHF (P = 0.016). Right ventricular-pulmonary vascular coupling was worse in Cpc-PH patients (end-systolic elastance to effective arterial elastance [Ees/Ea]: SHF: 1.05 ± 0.25; P = 0.002; DHF: 1.17 ± 0.27; P = 0.027) than in those with isolated post-capillary PH (Ees/Ea: SHF: 1.52 ± 0.51; DHF: 1.45 ± 0.29). CONCLUSIONS: Cpc-PH is rare in chronic heart failure. Right ventricular-pulmonary vascular coupling is poor in Cpc-PH and could be one explanation for dismal outcomes.

Gender-related clinical and echocardiographic outcomes at 30-day and 12-month follow up after MitraClip implantation in the GRASP registry.

OBJECTIVES: To assess the influence of patients' gender on the outcomes of percutaneous edge-to-edge mitral valve repair (PMVR) using the MitraClip system. BACKGROUND: Although gender-related differences have been extensively documented in patients who undergo surgery for moderate-to-severe (3+) and severe (4+) mitral regurgitation (MR), studies assessing whether these differences exist after PMVR are lacking. METHODS: Clinical and echocardiographic data through 12-month follow up from 171 consecutive patients whom underwent MitraClip implantation and were dichotomized by the gender (106 males and 65 females) were obtained. The primary safety endpoint was the incidence of major adverse events at 30 days and the primary efficacy endpoint was freedom from death, surgery for mitral valve dysfunction, or grade≥3+ MR at 12-month follow up. RESULTS: The primary safety endpoint was observed in four males (3.8%) and four females (6.2%) (P=0.358). Remarkable reduction in MR postprocedure was revealed in both groups, and these results were mostly sustained. Furthermore, left ventricle reverse remodeling and New York Heart Association (NYHA) functional class improvement were revealed in both groups, but females tended to demonstrate worse results over time (P=0.083). The primary efficacy endpoint obtained by Kaplan-Meier estimates was observed in 76.3 and 70.2%, respectively (log rank P=0.231). CONCLUSIONS: MitraClip implantation in patients with 3+ and 4+ MR is safe and efficacious until mid-term follow up, regardless of patients' gender. Despite improvement in NYHA functional class in both groups, female gender demonstrated a trend toward poorer results. Further validation of our findings is warranted.

Extended use of percutaneous edge-to-edge mitral valve repair beyond EVEREST (Endovascular Valve Edge-to-Edge Repair) criteria: 30-day and 12-month clinical and echocardiographic outcomes from the GRASP (Getting Reduction of Mitral Insufficiency by Percutaneous Clip Implantation) registry.

OBJECTIVES: This study sought to compare, in high-risk patients with 3+ to 4+ mitral regurgitation (MR) dichotomized by baseline echocardiographic features, acute, 30-day, and 12-month outcomes following percutaneous mitral valve repair using the MitraClip. BACKGROUND: The feasibility and mid-term outcomes after MitraClip implantation in patients with echocardiographic features different from the EVEREST (Endovascular Valve Edge-to-Edge Repair) I and II trials have been scarcely studied. METHODS: Clinical and echocardiographic outcomes through 12-month follow-up of consecutive patients who underwent MitraClip implantation were obtained from an ongoing prospective registry. Two different groups, divided according to baseline echocardiographic criteria (investigational group [EVERESTOFF] and control group [EVERESTON]), were compared. RESULTS: Seventy-eight patients were included in EVERESTOFF and 93 patients in EVERESTON groups. Important and comparable acute reductions in MR and no clip-related complications were revealed. The primary safety endpoint at 30 days was comparable between groups (2.6% vs. 6.5%, respectively, p = 0.204); in addition, MR reduction was mostly sustained, whereas equivalent improvement in New York Heart Association functional class were demonstrated. Kaplan-Meier freedom from death, surgery for mitral valve dysfunction, or grade ≥3+ MR at 12 months was demonstrated in 71.4% and 76.2%, respectively, in the EVERESTOFF and EVERESTON groups (log rank p = 0.378). Significant improvements in ejection fraction and reduction in left ventricle volumes were demonstrated in both groups over time, but the baseline between-group differences were sustained. CONCLUSIONS: MitraClip implantation in patients with expanded baseline echocardiographic features, compared with the control group, was associated with similar rates of safety and efficacy through 12-month follow-up. Further validation of our findings is warranted.

Left cardiac chambers reverse remodeling after percutaneous mitral valve repair with the MitraClip system.

BACKGROUND: Successful mitral valve surgical repair, decreasing volume overload, has been shown to provide reverse left ventricular (LV) and/or left atrial remodeling in most patients. Percutaneous mitral valve repair with the MitraClip system (Abbott, Abbott Park, IL) has been associated with favorable clinical outcomes in patients with mitral regurgitation at high risk of surgery. However, specific data on left cardiac chambers reverse remodeling after such procedures are limited. METHODS: This was a prospective observational study of consecutive patients at high risk of surgery, with moderate-to-severe or severe mitral regurgitation undergoing MitraClip system implantation. Follow-up echocardiography was performed at 6 months. The evaluated parameters were the LV end-diastolic and end-systolic volume indexes, LV sphericity index, LV ejection fraction, and left atrial volume index. Reverse LV remodeling was defined as a decrease of 10% in the LV end-diastolic volume index. RESULTS: The study population included 44 patients: 14 with degenerative and 30 with functional mitral regurgitation. At 6 months of follow-up, significant reductions in the median and interquartile range of the sphericity index (from 0.57 [interquartile range 0.54-0.62] to 0.54 [interquartile range 0.50-0.58]; P < .001), LV end-diastolic volume index (from 79.4 mL/m(2) [interquartile range 63.0-102.2] to 60.7 mL/m(2) [50.8-84.4]; P < .001), and LV end-systolic volume index (from 49.3 mL/m(2) [interquartile range 28.2-70.5] to 28.9 mL/m(2) [interquartile range 22.2-55.8]; P < .001) were observed. The LV ejection fraction improved significantly (from 38.0% [interquartile range 30.0-55.0%] to 46.0% [interquartile range 35.0-58.0%]; P < .001) from baseline to 6 months. Minor differences in the left atrial volume index were observed. Reverse remodeling, according to the specified definition, was observed in 77.3% of the patients. CONCLUSIONS: The present study reports positive LV reshape effects after mitral valve repair with the MitraClip system, showing significant improvements in LV size and function.

Accuracy of intracardiac echocardiography for aortic root assessment in patients undergoing transcatheter aortic valve implantation.

BACKGROUND: Multislice computed tomography (MSCT) has generally been accepted as the most accurate modality fulfilling this purpose with good reproducibility. A major drawback of MSCT consists in the use of contrast dye, which may be unsafe in transcatheter aortic valve implantation (TAVI) patients who frequently are affected by renal failure. We sought to appraise the accuracy of intracardiac echocardiography (ICE) in measurements of structures in the aortic root in patients undergoing TAVI. METHODS: Aortic annulus and sinus of Valsalva diameters were measured using ICE, performed during standard invasive preprocedural assessment in 30 consecutive patients with severe aortic stenosis referred for TAVI. Multislice computed tomography was performed in all patients afterward, and aortic root measurements were made by an independent radiologist. RESULTS: Effective ICE measurements were obtained in all patients, easily and without any complication. Mean aortic annulus diameters were 21.9 ± 1.8 mm using ICE, 22.0 ± 1.9 mm using MSCT (3-chamber [3-C] view) and 22.8 ± 1.8 mm using the mean of long-axis and short-axis (L-ax/S-ax) view MSCT (P = .192, ICE vs 3-C MSCT; P < .001, ICE vs L-ax/S-ax MSCT, respectively). Correlation between ICE and both MSCT measurements was good (r(2) = 0.83, P < .001; r(2) = 0.80, P < .001, respectively). Mean sinus of Valsalva diameters were 32.3 ± 3.3 mm using ICE and 32.5 ± 3.1 mm using 3-C MSCT view (P = .141). Even in this case, correlation between ICE and both MSCT measurements was excellent (r(2) = 0.96, P < .001). CONCLUSIONS: In patients referred for TAVI, measurements of the aortic annulus and the sinus of Valsalva using ICE compare favorably with those made at MSCT. This approach might be a useful and reproducible strategy in patients with severe renal impairment to avoid the administration of contrast dye during MSCT.

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.

Comparison of complications and outcomes to one year of transcatheter aortic valve implantation versus surgical aortic valve replacement in patients with severe aortic stenosis.

Comparisons of transcatheter aortic valve implantation (TAVI) to surgical aortic valve replacement (SAVR) in patients with severe aortic stenosis remain sparse or limited by a short follow-up. We sought to evaluate early and midterm outcomes of consecutive patients (n = 618) undergoing successful TAVI (n = 218) or isolated SAVR (n = 400) at 2 centers. The primary end point was incidence of Valvular Academic Research Consortium-defined major adverse cerebrovascular and cardiac events (MACCEs) up to 1 year. Control of potential confounders was attempted with extensive statistical adjustment by covariates and/or propensity score. In-hospital MACCEs occurred in 73 patients (11.8%) and was more frequent in patients treated with SAVR compared to those treated with TAVI (7.8% vs 14.0%, p = 0.022). After addressing potential confounders using 3 methods of statistical adjustment, SAVR was consistently associated with a higher risk of MACCEs than TAVI, with estimates of relative risk ranging from 2.2 to 2.6 at 30 days, 2.3 to 2.5 at 6 months, and 2.0 to 2.2 at 12 months. This difference was driven by an adjusted increased risk of life-threatening bleeding at 6 and 12 months and stroke at 12 months with SAVR. Conversely, no differences in adjusted risk of death, stroke and myocardial infarction were noted between TAVI and SAVR at each time point. In conclusion, in a large observational registry with admitted potential for selection bias and residual confounding, TAVI was not associated with a higher risk of 1-year MACCEs compared to SAVR.

Quality of life following percutaneous mitral valve repair with the MitraClip System.

BACKGROUND: Percutaneous valve repair with MitraClip System is an emerging alternative for high surgical risk patients with severe mitral regurgitation (MR). QoL is a critical measure of effectiveness of this procedure. We sought to evaluate quality of life (QoL) and NYHA class following this novel procedure. METHODS: The study included 39 consecutive patients who underwent mitral valve repair with the MitraClip System, both for functional (64%) and degenerative (36%) MR. All patients received the SF-12v2 questionnaire pre-procedure and at 6 months follow-up to assess the physical and mental health. RESULTS: Acute procedural success was obtained in 100%. Three patients experienced minor procedural complications. At follow-up 86% of patients had MR ≤ 1+ and 14% experienced a moderate MR. Mean pre-procedural SF-12v2 scores of our patients showed a severe impairment of perceived QoL, both for physical and mental scores; after six months a striking improvement in physical (PCS 35.44 vs 44.67, p<0.0001) and mental (MCS 38.07 vs 46.94, p<0.0001) aspect of QoL was observed. Furthermore, physical and mental status upgrading was higher in patients with functional MR. NYHA functional class improved in all patients. CONCLUSION: Our results show an early marked improvement in functional status and physical and mental health in patients underwent percutaneous mitral valve repair with the MitraClip System.

Quality-of-life in elderly patients one year after transcatheter aortic valve implantation for severe aortic stenosis.

AIMS: Transcatheter aortic valve implantation (TAVI) is an emerging alternative to medical therapy reserved to a limited population with severe aortic stenosis. Quality-of-life (QoL) is a critical measure of effectiveness of TAVI in this patient population. In this prospective study, we sought to assess one year changes in QoL in patients who underwent TAVI. METHODS AND RESULTS: From June 2007 to July 2010, 149 consecutive patients underwent TAVI using the 18 Fr CoreValve (Medtronic Inc, Minneapolis, MN, USA) or the Edwards SAPIEN XT heart valve (Edwards Lifescience, Irvine, CA, USA) at our institution. Of these, 143 patients with successful prosthesis implantation comprised the study population. The SF-12v2 Health-Survey questionnaire provides scales for physical (physical component summary [PCS]) and mental (mental component summary [MCS]) health. Among patients included in the present analysis, device success was obtained in 138 patients (96.5%). Mean preprocedural SF-12v2 scores showed an important upgrading after TAVI: PCS improved from 28.3 to 44.0 at five months and 42.4 at 12 months (p<0.001). MCS increased from 38.0 to 47.3 at five months and 48.2 at 12 months (p<0.001). Both the physical and mental score summaries at follow-up of these post-TAVI patients were not significantly different from the anticipated thresholds of the general Italian population over the age of 75 years. NYHA functional class improvement was reported in all patients. CONCLUSIONS: Our results showed a marked mid-term improvement in functional status and physical and mental health in patients who underwent TAVI.

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.

Postprocedural management of patients after transcatheter aortic valve implantation procedure with self-expanding bioprosthesis.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) carries higher risk of post-procedural adverse events than conventional percutaneous cardiovascular interventions. We report our experience about postoperative management protocol adopted in our Division. METHODS: One hundred and ten patients underwent TAVI and 108 were transferred to the cardiac intensive care unit (CICU) after procedure. During the first 48 hours, vital parameters were monitored continuously. Close attention was given to rhythm and atrio-ventricular conduction disturbances, systemic blood pressure, fluid balance and vascular accesses. RESULTS: The most common complications were renal impairment (21.3%), femoral artery pseudo-aneurysms (FAP) (11%), new complete atrioventricular block (20.3 %), cerebral vascular accident (4.5%) and cardiac perforation due to temporary pacemaker lead (1.8%). Ultrasound-guided compression repair was considered the first line treatment for FAP, but in 6 cases surgical treatment was immediately performed due to the rapid expansion of FAP. Complete atrio-ventricular block occurred in 22 patients (20.3 %) within the first 24 hours after TAVI and a permanent pacemaker was implanted in 21 patients (19.1%). Acute kidney injury occurred in 18 patients (35%) with pre-procedural chronic renal failure and in 5 patients (9%) without preoperative renal dysfunction. CONCLUSIONS: After TAVI, cardiovascular complications are common and therefore accurate standardized management of patients in CICU during the first 48 hours is mandatory to early detect and manage complications and to decrease the rate of adverse events and the length of in-hospital stay. © 2010 Wiley-Liss, Inc.