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Right ventricular impairment is common among patients undergoing transcatheter edge-to-edge repair for secondary mitral regurgitation (SMR). Adherence to guideline-directed medical therapy (GDMT) for heart failure is poor in these patients. The aim of this study was to evaluate the impact of GDMT on long-term survival in this patient cohort. Within the EuroSMR (European Registry of Transcatheter Repair for Secondary Mitral Regurgitation) international registry, we selected patients with SMR and right ventricular impairment (tricuspid annular plane systolic excursion ≤17 mm and/or echocardiographic right ventricular–to–pulmonary artery coupling <0.40 mm/mm Hg). Titrated guideline-directed medical therapy (GDMT tit) was defined as a coprescription of 3 drug classes with at least one-half of the target dose at the latest follow-up. The primary outcome was all-cause mortality at 6 years. Among 1,213 patients with SMR and right ventricular impairment, 852 had complete data on medical therapy. The 123 patients who were on GDMT tit showed a significantly higher long-term survival vs the 729 patients not on GDMT tit (61.8% vs 36.0%; P < 0.00001). Propensity score–matched analysis confirmed a significant association between GDMT tit and higher survival (61.0% vs 43.1%; P = 0.018). GDMT tit was an independent predictor of all-cause mortality (HR: 0.61; 95% CI: 0.39-0.93; P = 0.02 for patients on GDMT tit vs those not on GDMT tit). Its association with better outcomes was confirmed among all subgroups analyzed. In patients with right ventricular impairment undergoing transcatheter edge-to-edge repair for SMR, titration of GDMT to at least one-half of the target dose is associated with a 40% lower risk of all-cause death up to 6 years and should be pursued independent of comorbidities. [Display omitted] [ABSTRACT FROM AUTHOR]

Early studies of the Tendyne transcatheter mitral valve replacement (TMVR) showed promising results in a small selective cohort. The authors present 1-year data from the currently largest commercial, real-world cohort originating from the investigator-initiated TENDER (Tendyne European Experience) registry. All patients from the TENDER registry eligible for 1-year follow-up were included. The primary safety endpoint was 1-year cardiovascular mortality. Primary performance endpoint was reduction of mitral regurgitation (MR) up to 1 year. Among 195 eligible patients undergoing TMVR (median age 77 years [Q1-Q3: 71-81 years], 60% men, median Society of Thoracic Surgeons Predicted Risk of Mortality 5.6% [Q1-Q3: 3.6%-8.9%], 81% in NYHA functional class III or IV, 94% with MR 3+/4+), 31% had "real-world" indications for TMVR (severe mitral annular calcification, prior mitral valve treatment, or others) outside of the instructions for use. The technical success rate was 95%. The cardiovascular mortality rate was 7% at 30 day and 17% at 1 year (all-cause mortality rates were 9% and 29%, respectively). Reintervention or surgery following discharge was 4%, while rates of heart failure hospitalization reduced from 68% in the preceding year to 25% during 1-year follow-up. Durable MR reduction to ≤1+ was achieved in 98% of patients, and at 1 year, 83% were in NYHA functional class I or II. There was no difference in survival and major adverse events between on-label use and "real-world" indications up to 1 year. This large, real-world, observational registry reports high technical success, durable and complete MR elimination, significant clinical benefits, and a 1-year cardiovascular mortality rate of 17% after Tendyne TMVR. Outcomes were comparable between on-label use and "real-world" indications, offering a safe and efficacious treatment option for patients without alternative treatments. (Tendyne European Experience Registry [TENDER]; NCT04898335) [Display omitted] [ABSTRACT FROM AUTHOR]

Secondary mitral regurgitation (SMR) is a progressive disease with characteristic pathophysiological changes that may influence prognosis. Although the staging of SMR patients suffering from heart failure with reduced ejection fraction (HFrEF) according to extramitral cardiac involvement has prognostic value in medically treated patients, such data are so far lacking for edge-to-edge mitral valve repair (M-TEER). This study sought to classify M-TEER patients into disease stages based on the phenotype of extramitral cardiac involvement and to assess its impact on symptomatic and survival outcomes. Based on echocardiographic and clinical assessment, patients were assigned to 1 of the following HFrEF-SMR groups: left ventricular involvement (Stage 1), left atrial involvement (Stage 2), right ventricular volume/pressure overload (Stage 3), or biventricular failure (Stage 4). A Cox regression model was implemented to investigate the impact of HFrEF-SMR stages on 2-year all-cause mortality. The symptomatic outcome was assessed with New York Heart Association functional class at follow-up. Among a total of 849 eligible patients who underwent M-TEER for relevant SMR from 2008 until 2019, 9.5% (n = 81) presented with left ventricular involvement, 46% (n = 393) with left atrial involvement, 15% (n = 129) with right ventricular pressure/volume overload, and 29% (n = 246) with biventricular failure. An increase in HFrEF-SMR stage was associated with increased 2-year all-cause mortality after M-TEER (HR: 1.39; CI: 1.23-1.58; P < 0.01). Furthermore, higher HFrEF-SMR stages were associated with significantly less symptomatic improvement at follow-up. The classification of M-TEER patients into HFrEF-SMR stages according to extramitral cardiac involvement provides prognostic value in terms of postinterventional survival and symptomatic improvement. [Display omitted] [ABSTRACT FROM AUTHOR]

Background: The SMall Annuli Randomized To Evolut or SAPIEN (SMART) Trial was designed to compare the performance of the two most widely available commercial transcatheter aortic valve replacement (TAVR) devices in patients with symptomatic severe native aortic stenosis with a small aortic valve annulus undergoing transfemoral TAVR. Patients with small aortic valve annuli are typically female and are often underrepresented in clinical trials.Methods: The SMART Trial is an international, prospective, multi-center, randomized controlled, post-market trial. The trial will be conducted in approximately 700 subjects at approximately 90 sites globally. Inclusion criteria include severe aortic stenosis, aortic valve annulus area of ≤430 mm2 based on multi-detector computed tomography, and appropriate anatomy for both the Medtronic Evolut PRO/PRO+ self-expanding and Edwards SAPIEN 3/3 Ultra balloon-expandable devices. The primary clinical outcome composite endpoint is defined as mortality, disabling stroke or heart failure rehospitalization at 12 months. The co-primary valve function composite endpoint is defined as bioprosthetic valve dysfunction at 12 months which includes hemodynamic structural valve dysfunction, defined as a mean gradient ≥20 mmHg, non-structural valve dysfunction, defined as severe prothesis-patient mismatch or ≥moderate aortic regurgitation, thrombosis, endocarditis, and aortic valve re-intervention. Powered secondary endpoints will be assessed hierarchically.Conclusions: The SMART trial will be the largest head-to-head comparative trial of transfemoral TAVR using the two most widely available contemporary TAVR devices in the setting of small aortic annuli and the largest trial to enroll primarily women.Clinical Trial Registration: URL: www.clinicaltrials.gov, Unique identifier: NCT04722250. [ABSTRACT FROM AUTHOR]

The aim of this study was to evaluate whether fulfilling COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation) criteria identifies patients with better outcomes after MitraClip treatment for secondary mitral regurgitation (SMR). To date, COAPT is the only trial showing a prognostic benefit of MitraClip implantation compared with conservative management. Three hundred four patients with SMR undergoing MitraClip placement in addition to optimal medical therapy at 3 European centers were analyzed. A COAPT-like profile was defined as absence of all the following criteria: severe left ventricular impairment, moderate to severe right ventricular dysfunction, severe tricuspid regurgitation, severe pulmonary hypertension, and hemodynamic instability. Freedom from all-cause death and from a composite endpoint (cardiovascular death and heart failure hospitalization) were evaluated at 2- and 5-year follow-up. A COAPT-like profile was observed in 65% of the population. Compared with non-COAPT-like patients, those fulfilling COAPT criteria had greater survival free from all-cause death and from the composite endpoint at both 2 year (75% vs. 55% and 67% vs. 47%; p < 0.001 for both) and 5-year (49% vs. 25% and 40% vs. 19%; p < 0.001 for both) follow-up. Among the non-COAPT-like patients, similar outcomes were observed in those fulfilling 1 or ≥1 criterion. Left ventricular impairment had a late impact on outcomes, while right ventricular impairment, pulmonary hypertension, and hemodynamic instability had early effects. COAPT-like profile was an independent predictor of long-term outcomes, as well as administration of neurohormonal antagonists, European System for Cardiac Operative Risk Evaluation II score, and previous heart failure hospitalization. A COAPT-like profile, including specific echocardiographic and clinical criteria, identifies patients with SMR who have a better prognosis after MitraClip implantation. [ABSTRACT FROM AUTHOR]

No indication are available for transcatheter aortic valve implantation (TAVI) sizing in bicuspid aortic valve (BAV). Aim of the study is to develop and validate a Multi-Slice Computed Tomography (MSCT)-based algorithm for transcatheter heart valve (THV) sizing in patients with stenotic BAV under evaluation for TAVI. A two steps method was applied: 1)evaluation of a cohort of 19 consecutive patients with type I BAV stenosis undergoing TAVI through pre and post-procedural MSCT, and development of an algorithm for THV sizing; 2)validation of the algorithm on a new cohort of 21 patients. In the first cohort, a high correlation was found between the raphe-level area measured at pre-procedural MSCT and the smallest THV area measured at post-procedural MSCT (p < 0.001). Moreover, reduced THV expansion was observed among patients with higher calcium burden (p = 0.048). Then, a new algorithm for TAVI sizing in BAV was develop (CASPER : Calcium Algorithm Sizing for bicusPid Evaluation with Raphe). This algorithm is based on the reassessment of the perimeter/area derived annulus diameter, according to three main anatomical features: 1) the ratio between raphe length and annulus diameter; 2)calcium burden; 3)calcium distribution in relation to the raphe. The algorithm was then validated in a new cohort of 21 patients, achieving 100% of procedural success and excellent TAVI performance. MSCT assessment of raphe length, calcium burden and its distribution is of crucial relevance in the pre-procedural evaluation of patients with BAV. These anatomical features can be combined in a new and simple algorithm for TAVI sizing. [ABSTRACT FROM AUTHOR]

Limited evidence is available on 5-year clinical outcomes after percutaneous edge-to-edge mitral valve repair.Methods: The Getting Reduction of mitrAl inSufficiency by Percutaneous clip implantation in ITaly (GRASP-IT) is a multicenter registry including 304 consecutive patients undergoing Mitraclip between October 2008 and October 2013 at 4 Italian centers. Primary end point (all-cause mortality) and secondary end point (all-cause mortality or heart failure [HF] hospitalization) were evaluated up to 5 years and between 1 and 5 years.Results: Cumulative incidence of the primary and secondary end points at 1, 2, 3, 4, and 5 years were 15.1%, 26.4%, 35.5%, 42.1%, and 47.3% and 29.1%, 41.7%, 49.8%, 56%, and 62.3%, respectively. Landmark analysis between 1 and 5 years showed an incidence of primary and secondary end point of 37.9% and 46.8%, respectively. Five-year event rates were significantly higher in patients with functional ischemic mitral regurgitation (MR) compared to other etiologies. MR recurrence and left ventricular ejection fraction <30% were associated with an increased risk of both primary and secondary end points. EuroSCORE II >5% was associated with an increased risk of 5-year mortality. Ischemic etiology of MR, baseline serum creatinine >1.5 mg/dL, chronic obstructive pulmonary disease, and previous HF hospitalizations were independent predictors of 5-year secondary end point.Conclusions: At 5-year follow-up after Mitraclip, nearly half of patients died and almost two thirds died or were admitted for HF. MR recurrence, ischemic etiology, high comorbidity burden (ie, EuroSCORE II >5%, chronic obstructive pulmonary disease), and advanced cardiomyopathy (ie, left ventricular ejection fraction <30%, prior HF admission, creatinine >1.5 mg/dL) significantly increase the relative risk of 5-year clinical events. [ABSTRACT FROM AUTHOR]

Background Aortic valve calcification patterns were associated with short- and long-term outcomes in previous small observational datasets of patients undergoing transcatheter aortic valve implantation (TAVI). The specific impact of multi detector-row computed tomography (MDCT) findings on outcomes in women has not been reported. We sought to describe the associations between MDCT characteristics and clinical outcomes in a registry of 547 women undergoing TAVI. Methods WIN-TAVI is the first all-female registry to study the safety and effectiveness of TAVI in women (n = 1019). Thirteen sites participated in the MDCT sub-study and contributed pre-TAVI MDCT studies in 547 consecutive subjects. All MDCT data were analyzed in an independent core lab blinded to clinical outcomes. Key measurements included number of valve leaflets, aortic annulus area and perimeter, left and right coronary artery height, aortic cusp calcium volume, commissural calcification and left ventricular outflow tract (LVOT) calcification. Calcium volume of the aortic valvular complex was quantified using a threshold relative to patient-specific contrast attenuation in the arterial blood pool. We examined univariate and multivariate associations between ECG-gated contrast MDCT characteristics and 1-year mortality or stroke, new pacemaker implantation and new onset atrial fibrillation (AF). Results The CT sub-study sample had a mean age of 82.8 ± 6.3 years, mean logistic EuroSCORE of 17.8 ± 11.3%, and mean STS score of 8.2 ± 7.4%. Transfemoral access was used in 89.6% of patients. After multivariate adjustment, moderate or severe LVOT calcification was an independent predictor of 1-year mortality or stroke (HR = 1.91; 95% CI: 1.11–3.30; p = 0.02). Calcium volume in the right coronary cusp was an independent predictor of new pacemaker (HR = 1.18 per 100 m 3 increment; p = 0.04), whereas calcium volume of the non-coronary cusp had a protective effect (HR = 0.78 per 100 mm 3 increment; p = 0.004). Severe calcification of the non-coronary/right-coronary commissure was an independent predictor of new AF (HR = 5.1; p = 0.008). Conclusion Computed tomography provides important prognostic information in women undergoing TAVI. Moderate or severe LVOT calcification is associated to an almost two-fold increased risk of mortality or stroke at one year. Different calcification patterns of the aortic valve may predict diverse rhythm abnormalities. [ABSTRACT FROM AUTHOR]

Background: Transcatheter mitral valve replacement (TMVR) is an emerging therapeutic alternative for patients with secondary mitral regurgitation (MR). Outcomes of TMVR versus guideline-directed medical therapy (GDMT) have not been investigated for this population. This study aimed to compare clinical outcomes of patients with secondary MR undergoing TMVR versus GDMT alone. Methods: The CHOICE-MI registry (Choice of Optimal Transcatheter Treatment for Mitral Insufficiency) included patients with MR undergoing TMVR using dedicated devices. Patients with MR pathogeneses other than secondary MR were excluded. Patients treated with GDMT alone were derived from the control arm of the COAPT trial (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation). We compared outcomes between the TMVR and GDMT groups, using propensity score matching to adjust for baseline differences. Results: After propensity score matching, 97 patient pairs undergoing TMVR (72.9±8.7 years; 60.8% men; transapical access, 91.8%) versus GDMT (73.1±11.0 years; 59.8% men) were compared. At 1 and 2 years, residual MR was ≤1+ in all patients of the TMVR group compared with 6.9% and 7.7%, respectively, in those receiving GDMT alone (both P <0.001). The 2-year rate of heart failure hospitalization was significantly lower in the TMVR group (32.8% versus 54.4%; hazard ratio, 0.59 [95% CI, 0.35–0.99]; P =0.04). Among survivors, a higher proportion of patients were in the New York Heart Association functional class I or II in the TMVR group at 1 year (78.2% versus 59.7%; P =0.03) and at 2 years (77.8% versus 53.2%; P =0.09). Two-year mortality was similar in the 2 groups (TMVR versus GDMT, 36.8% versus 40.8%; hazard ratio, 1.01 [95% CI, 0.62–1.64]; P =0.98). Conclusions: In this observational comparison, over 2-year follow-up, TMVR using mostly transapical devices in patients with secondary MR was associated with significant reduction of MR, symptomatic improvement, less frequent hospitalizations for heart failure, and similar mortality compared with GDMT. Registration: URL: https://clinicaltrials.gov; Unique identifier: NCT04688190 (CHOICE-MI) and NCT01626079 (COAPT). [ABSTRACT FROM AUTHOR]

Background: Elderly patients display higher on clopidogrel platelet reactivity as compared with younger patients. Treatment with prasugrel 5mg has been shown to provide more predictable and homogenous antiplatelet effect, as compared with clopidogrel, suggesting the possibility of reducing ischemic events after an acute coronary syndrome (ACS) without increasing bleeding.Study Design: The Elderly-ACS 2 study is a multicenter, randomized, parallel-group, open-label trial designed to demonstrate the superiority of a strategy of dual antiplatelet treatment using a reduced 5-mg daily dose of prasugrel over a standard strategy with a daily clopidogrel dose of 75mg in patients older than 74years with ACS (either ST- or non-ST-elevation myocardial infarction) undergoing early percutaneous revascularization. The primary end point is the composite of all-cause mortality, myocardial reinfarction, disabling stroke, and rehospitalization for cardiovascular causes or bleeding within 1 year. Taking advantage of the planned size of 2,000 patients, the secondary objective is to assess the prognostic impact of selected prerandomization variables (age, sex, diabetic status, serum creatinine level, electrocardiogram changes, abnormal troponin levels, basal and residual SYNergy between percutaneous coronary intervention with TAXus and cardiac surgery [SYNTAX] score).Conclusion: The Elderly-ACS 2 study is a multicenter, randomized trial comparing a strategy of dual antiplatelet therapy with a reduced dose of prasugrel with a standard dose of clopidogrel in elderly patients with ACS undergoing percutaneous revascularization (the Elderly ACS 2 trial: NCT01777503). [ABSTRACT FROM AUTHOR]

Objectives The study sought to examine the safety and performance of transcatheter aortic valve replacement (TAVR) using an all-female registry and to further explore the potential impact of female sex-specific characteristics on clinical outcomes after TAVR. Background Although women comprise 50% of patients with symptomatic severe aortic stenosis undergoing TAVR, the optimal treatment strategy remains undetermined. Methods The WIN-TAVI (Women’s INternational Transcatheter Aortic Valve Implantation) registry is a multinational, prospective, observational registry of women undergoing TAVR for aortic stenosis, conducted without any external funding. The primary endpoint was the Valve Academic Research Consortium (VARC)-2 early safety endpoint at 30 days (composite of mortality, stroke, major vascular complication, life-threatening bleeding, stage 2 or 3 acute kidney injury, coronary artery obstruction, or repeat procedure for valve-related dysfunction). Results Between January 2013 and December 2015, 1,019 women were enrolled across 19 European and North American centers. The mean patient age was 82.5 ± 6.3 years, mean EuroSCORE I was 17.8 ± 11.7% and mean Society of Thoracic Surgeons score was 8.3 ± 7.4%. TAVR was performed via transfemoral access in 90.6% and new-generation devices were used in 42.1%. In more than two-thirds of cases, an Edwards SAPIEN 23 mm (Edwards Lifesciences, Irvine, California) or Medtronic CoreValve ≤26 mm (Medtronic Inc., Minneapolis, Minnesota) device was implanted. The 30-day VARC-2 composite endpoint occurred in 14.0% with 3.4% all-cause mortality, 1.3% stroke, 7.7% major vascular complications, and 4.4% VARC life-threatening bleeding. The independent predictors of the primary endpoint were age (odds ratio [OR]: 1.04; 95% confidence interval [CI]: 1.00 to 1.08), prior stroke (OR: 2.02; 95% CI: 1.07 to 3.80), left ventricular ejection fraction <30% (OR: 2.62; 95% CI: 1.07 to 6.40), new device generation (OR: 0.59; 95% CI: 0.38 to 0.91), and history of pregnancy (OR: 0.57; 95% CI: 0.37 to 0.85). Conclusions Women enrolled in this first ever all-female TAVR registry with collection of female sex-specific baseline parameters, were at intermediate-high risk and experienced a 30-day VARC-2 composite safety endpoint of 14.0% with a low incidence of early mortality and stroke. Randomized assessment of TAVR versus surgical aortic valve replacement in intermediate risk women is warranted to determine the optimal strategy. [ABSTRACT FROM AUTHOR]

Background--Severe pulmonary hypertension (PH) is considered to negatively affect the outcome after transcatheter aortic valve replacement. However, a clear understanding of the pattern, evolution, and clinical impact of different grades of PH in this setting is lacking. Methods and Results--A total of 990 consecutive patients were enrolled in 6 high-volume centers and analyzed as follows: group 1, systolic pulmonary artery pressure (sPAP) <40 mm Hg (346 patients; 35%); group 2, sPAP 40 to 60 mm Hg (426 patients; 43%); and group 3, sPAP >60 mm Hg (218 patients; 22%). At 1 month, mortality rate did not differ across the groups. When compared with groups 1 and 2, patients in group 3 had a higher-rate of New York Heart Association 3 to 4 (26% versus 12% and 10%), and a higher-rate of hospitalization for heart failure (7% versus 3% and 3%). At 1 year, when compared with patients in group 1, patients in group 2 and 3 had both a higher overall mortality (hazard ratio [HR], 1.5 [1.3-3.2]; P=0.01 and HR, 2.3 [1.8-2.8]; P=0.001) and a higher cardiac mortality (HR, 1.3 [1.1-2.1]; P=0.01 and HR, 1.7 [1.3-2.5]; P=0.002). After 1 month, the sPAP decreased ≥15 mm Hg in 32% and 35% of the patients in groups 2 and 3. Baseline sPAP >60 mm Hg (HR, 1.6 [1.1-2.3]; P=0.03) and, in a larger extent, a persistent severe PH after 1 month (HR, 2.4 [1.5-2.8]; P=0.004), independently predicted 1-year mortality, whereas the 1-month reduction of the sPAP did not. Conclusions--The persistence of severe PH after transcatheter aortic valve replacement is a stronger predictor of 1-year mortality than baseline severe PH. The early reduction of sPAP is not associated with a reduced mortality. The benefit of transcatheter aortic valve replacement in terms of quality of life is substantial in patients with and without a reduction of sPAP at early follow-up. [ABSTRACT FROM AUTHOR]

Objectives The purpose of this analysis was to assess 5-year outcomes of transcatheter aortic valve implantation (TAVI) using the current technology of the self-expanding CoreValve prosthesis (Medtronic Inc., Minneapolis, Minnesota). Background There is a paucity of evidence on long-term durability of currently available transcatheter heart valves. Methods Starting in June 2007, all consecutive patients with severe aortic stenosis undergoing TAVI with the third-generation 18-F CoreValve device in 8 Italian centers were prospectively included in the ClinicalService Project. For the purposes of this study, we included only consecutive patients with 5-year follow-up data available (n = 353) treated from June 2007 to August 2009. All outcomes were reported according to VARC (Valve Academic Research Consortium)-1 criteria. Results All-cause mortality rates at 1, 2, 3, 4, and 5 years were 21%, 29%, 38%, 48%, and 55.0%, respectively. Cardiovascular mortality rates at 1, 2, 3, 4, and 5 years were 10%, 14%, 19%, 23%, and 28.0%, respectively. The overall neurological event rate at 5 years was 7.5%, of which more than two-thirds occurred early after the procedure. During follow-up, there were 241 rehospitalizations for cardiovascular reasons in 164 (46%) patients. Among all rehospitalizations, acute heart failure was the most frequently reported (42.7%), followed by requirement of permanent pacemaker implantation (17.4%). On echocardiography, mean transaortic gradients decreased from 55.6 ± 16.8 mm Hg (pre-TAVI) to 12.8 ± 10.9 mm Hg (5-year post-TAVI) (p < 0.001). Late prosthesis failure occurred in 5 cases (1.4%); among these, redo TAVI was successfully carried out in 2 patients (0.6%) presenting with symptomatic prosthesis restenosis. The remaining 3 cases of prosthesis failure did not undergo further invasive interventions. Ten patients (2.8%) showed late mild stenosis with a mean transaortic gradient ranging from 20 to 40 mm Hg. No other cases of structural or nonstructural valvular deterioration were observed. Valve thrombosis or late valve embolization were not reported. Conclusions TAVI with the currently adopted CoreValve generation was associated with sustained clinical outcomes up to 5-year follow-up, with a low rate (1.4%) of significant prosthetic valve degeneration. The procedure appears to be an adequate and lasting resolution of aortic stenosis in selected high-risk patients. [ABSTRACT FROM AUTHOR]

Background There is limited information on the long-term outcomes and prognostic clinical predictors after edge-to-edge transcatheter mitral valve repair with the MitraClip system. Methods Consecutive patients with mitral regurgitation (MR) undergoing MitraClip therapy between October 2008 and November 2013 in 4 Italian centers were analyzed. The primary end point of interest was all-cause death. The secondary end point was the composite of all-cause death or rehospitalization for heart failure. Results A total of 304 patients were included, of which 79% had functional MR and 17% were in New York Heart Association functional class IV. Acute procedural success was obtained in 92% of cases, with no intraprocedural death. The cumulative incidences of all-cause death were 3.4%, 10.8%, and 18.6% at 30 days, 1 year, and 2 years, respectively. The corresponding incidences of the secondary end point were 4.4%, 22.0%, and 39.7%, respectively. In the Cox multivariate model, New York Heart Association functional class IV at baseline and ischemic MR etiology were found to significantly and independently predict both the primary and the secondary end point. A baseline, left ventricular end-systolic volume >110 mL was found to be an independent predictor of the secondary endpoint. Acute procedural success was independently associated with a lower risk of all-cause death and the combination of all-cause death or rehospitalization for heart failure at long-term follow-up. Conclusions In a cohort of patients undergoing MitraClip therapy, those presenting at baseline with ischemic functional etiology, severely dilated ventricles, or advanced heart failure and those undergoing unsuccessful procedures carried the worst prognosis. [ABSTRACT FROM AUTHOR]

Objectives The aim of the CoreValve prospective, international, post-market ADVANCE-II study was to define the rates of conduction disturbances and permanent pacemaker implantation (PPI) after transcatheter aortic valve replacement with the Medtronic CoreValve System (Minneapolis, Minnesota) using optimized implantation techniques and application of international guidelines on cardiac pacing. Background Conduction disturbances are a frequent complication of transcatheter aortic valve replacement. The rates of PPI in the published reports vary according to bioprosthesis type and the indications for PPI. Methods The primary endpoint was the 30-day incidence of PPI with Class I/II indications when the Medtronic CoreValve System was implanted at an optimal depth (≤6 mm below the aortic annulus). The timing and resolution of all new-onset conduction disturbances were analyzed. Results A total of 194 patients were treated. The overall rate of PPI for Class I/II indications was 18.2%. An optimal depth was reached in 43.2% of patients, with a nonsignificantly lower incidence of PPI in patients with depths ≤6 mm, compared with those with deeper implants (13.3% vs. 21.1%; p = 0.14). In a paired analysis, new-onset left bundle branch block and first-degree atrioventricular block occurred in 45.4% and 39.0% of patients, respectively, and resolved spontaneously within 30 days in 43.2% and 73.9%, respectively. In patients with new PPI, the rate of intrinsic sinus rhythm increased from 25.9% at 7 days to 59.3% at 30 days (p = 0.004). Conclusions Optimal Medtronic CoreValve System deployment and adherence to international guidelines on cardiac pacing are associated with a lower rate of new PPI after transcatheter aortic valve replacement, compared with results reported in previous studies. (CoreValve Advance-II Study: Prospective International Post-Market Study [ADVANCE II]; NCT01624870 ) [ABSTRACT FROM AUTHOR]

Objectives The aim of this study was to assess the incidence and clinical impact of balloon post-dilation (BPD) after transcatheter aortic valve replacement (TAVR) with the CoreValve prosthesis (Medtronic Inc., Minneapolis, Minnesota). Background BPD is a widely adopted strategy to reduce the degree of paraprosthetic regurgitation in case of transcatheter heart valve underexpansion. However, controversies still remain regarding its real effectiveness and safety. Methods The ClinicalService (a nation-based data repository and medical care project) dataset was analyzed. All patients were dichotomized according to the need for BPD during the index procedure. Results Among 1,376 patients, BPD of the transcatheter heart valve was performed in 272 (19.8%). In 37% of cases, it was unsuccessful at reducing the paravalvular regurgitation to mild or less. No case of valve embolization, new intravalvular regurgitation, coronary occlusion, and aortic root injury occurred during BPD. There were no statistically significant differences between the 2 groups in the incidence of in-hospital all-cause and cardiovascular mortality, neurological events, myocardial infarction, bleeding, conversion to open-chest surgery, and the need for a permanent pacemaker. The need for BPD did not emerge as an independent risk factor for all-cause (adjusted hazard ratio [HR]: 1.33, 95% confidence interval [CI]: 0.81 to 2.19, p = 0.264) and cardiovascular (adjusted HR: 1.48, 95% CI: 0.74 to 2.97, p = 0.265) mortality at 1 year after the procedure. In addition, BPD did not predispose to higher odds of neurological events during 12 months after TAVR (HR: 0.92, 95% CI: 0.45 to 1.88, p = 0.815). Conclusions This large study showed that BPD after TAVR was safe and not associated with increased rates of cerebrovascular events, mortality, myocardial infarction, and aortic root injury. [ABSTRACT FROM AUTHOR]

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Background: Conduction abnormalities are frequent after transcatheter aortic valve implantation with the CoreValve (Medtronic, Minneapolis, MN) and are often treated with liberal permanent pacemaker (PPM) implantation. Our aim was to assess the 1-year outcome of a conservative approach to pacing and to identify its predictors. Methods: We analyzed 275 consecutive patients without a PPM before transcatheter aortic valve implantation who underwent successful CoreValve implantation at our 3 centers, sharing a conservative approach to pacing. Results: Of the 47 patients (17.1%) who developed postprocedural complete atrioventricular block, 14 recovered spontaneous atrioventricular conduction <72 hours and did not receive a PPM. Sixty-six patients (24.0%) received a PPM before discharge, and 74 more patients (26.9%) developed a new left bundle-branch block (LBBB). Independent predictors of PPM implantation were as follows: lower CoreValve implantation below the aortic annulus (odds ratio [OR] 1.16/mm, 95% CI 1.03-1.30, P = .01), right bundle-branch block (OR 3.72, 95% CI 1.5-9.2, P = .004), left anterior hemiblock (OR 2.34, 95% CI 1.1-5.1, P = .03), and longer PR interval (OR 1.02/ms, 95% CI 1.00-1.04, P = .03). One-year survival was similar between patients who received a PPM and patients who did not receive a PPM (P = .90), with no case of sudden death in the latter group, and between patients with a new LBBB not receiving a PPM and patients without postprocedural LBBB (P = .37). Conclusion: A high CoreValve implantation level and avoidance of prophylactic pacing in patients with new LBBB without persistent bradyarrhythmias allowed for a relatively low rate of PPM implantation. This conservative approach spared unwarranted pacing and did not affect 1-year survival. [Copyright &y& Elsevier]

Objectives: The purpose of this study was to evaluate the performance of CoreValve Revalving System (CRS) (Medtronic, Minneapolis, Minnesota) implantation in patients with failed aortic bioprostheses. Background: Transcatheter aortic valve implantation with the CRS is an effective option in high-risk patients with severe aortic stenosis. It may be an option for patients with a failed aortic bioprosthesis, especially when the risk of a surgical redo is deemed prohibitive. Methods: CRS “valve-in-valve” implantation was performed in 25 high-risk patients with a failed bioprosthesis. Their mean age was 82.4 ± 3.2 years. New York Heart Association functional classes III and IV were present in 21 and 4 patients, respectively. The logistic EuroSCORE was 31.5 ± 14.8%, whereas the Society of Thoracic Surgeons score was 8.2 ± 4.2. Patients/prostheses were divided in type A (mainly stenotic, n = 9) and type B (mainly regurgitant, n = 16). Results: The implantation success rate was 100%. In group A, the peak aortic gradient significantly decreased from 77.6 ± 21.6 mm Hg to 34.6 ± 19.4 mm Hg (p = 0.001). In all but 2 patients in group B, no significant regurgitation was observed post-implantation. No patients died during the procedure. At 30 days, there were 3 deaths (12%), 2 myocardial infarctions (8%), and 3 atrioventricular blocks requiring pacemaker implantation (12%). At a mean follow-up of 6 months, there were another death (survival rate of 84%) and a pacemaker implantation (cumulative incidence of 16%). New York Heart Association functional class improved in all patients to I and II. Conclusions: CRS implantation was feasible and effective regardless of the prevalent mode of failure. This finding may significantly affect the treatment of patients with a failed bioprosthesis deemed at a prohibitive risk for surgical redo. [Copyright &y& Elsevier]

The article discusses a study on the relative benefits of using different stent types for diabetes mellitus (DM) patients with coronary bifurcation lesions submitted to percutaneous coronary intervention (PCI). Patients who underwent PCI for coronary bifurcations of a major epicardial vessel stenosis between March 2002 and December 2005 were enrolled. It suggests that the use of DES in DM patients was associated with improved outcomes in terms of major adverse cardiac events (MACE), cardiac death and repeat revascularization at long-term follow up.

The article discusses a research study on the subclavian approach for transcatheter aortic valve implantation (TAVI) and its safety and efficacy with CoreValue revalving system. Study subjects include 514 consecutive patients in Italian hospitals from 2007 - 2009 with the CoreValue bioprosthesis, 54 case of which used the subclavian approach and compared complications, comorbidites and mortality. Conclusions indicated safety of the subclavian approach for TAVI with low complication rates.

The article presents a study that determined the feasibility of a trans-subclavian approach for transcatheter aortic valve implantation (TAVI) with CoreValve revalving system on patients with cases of unfavorable iliofemoral anatomy or extensive disease. TAVI with the CoreValve bioprosthesis were performed in 514 patients at 13 Italian hospitals using the subclavian approach in 54 cases. Results showed feasibility and safety of the subclavian approach with excellent procedural success and low in-hospital complications.

Background: Distal embolization during primary percutaneous coronary interventions (PCIs) may affect myocardial reperfusion. We evaluated the prevalence and features of embolization during primary PCI and its relationship with clinical and angiographic variables. Methods: Forty-six consecutive patients with acute myocardial infarction underwent primary PCI with a filter-based distal protection device. Histopathologic analysis was performed on retrieved embolic fragments, assessing the presence and relative amount of fibrin, necrosis, lipid droplets, collagen, mucopolysaccharides, and leukocytes, as well as the total debris volume. Such variables were related to baseline clinical and angiographic variables. Results: Embolic material was recovered in 41 (89%) of 46 cases, with a mean total debris volume of 1.2 ± 2.2 mm3. Prevalent histopathologic patterns were organized thrombus (47%), fresh thrombus (29%), and plaque fragments (24%). At multivariate analysis, none of the baseline clinical variables considered significantly predicted the total debris volume. Among angiographic variables, angiographic signs of high thrombus burden (cut-off coronary occlusion pattern or large intracoronary minus image) independently predicted the total debris volume at multivariate analysis (odds ratio 15.8, P < .005). Compared with its nonuse, abciximab did not affect the total number and the mean total volume of embolized material (15 ± 16 vs 10 ± 8 fragments, 1.5 ± 2.5 vs 1.0 ± 1.9 mm3, respectively, for both P > .20), or its qualitative composition. Conclusions: Distal embolization occurs in most patients during primary PCI and mainly consists of plaque fragments and partially organized thrombi, which are likely to be scarcely responsive to antiplatelet drugs. Baseline angiographic signs of a high thrombus burden are the only significant predictors of the extent of distal embolization. [Copyright &y& Elsevier]

Background: Restenosis after coronary stenting is mainly caused by intimal hyperplasia. Both experimental and clinical studies suggest that statins may be able to inhibit intimal hyperplasia and, therefore, in-stent restenosis (ISR), by mechanisms beyond lipid lowering. Methods: In a 12-month study, we randomized 71 normocholesterolemic patients to 20 mg simvastatin or no treatment, 2 weeks before elective coronary stenting. Patients were evaluated by quantitative coronary angiography and intravascular ultrasound, immediately after the index procedure and at the 12-month catheterization. Results: Binary ISR was present in 15% and in 18% of simvastatin-treated patients and controls, respectively (P = NS). Intimal hyperplasia did not differ significantly between the 2 groups (3.6 ± 1.8 vs 3.8 ± 2.3 mm3/mm, 34% ± 15% vs 35% ± 23% for simvastatin vs controls, P = NS). However, peristent plaque decreased with simvastatin but increased in controls (−4.0 ± 4.0 vs +1.6 ± 3.8 mm3/mm, −14% ± 10% vs +6% ± 12%, P < .05). The same behavior was shown by intermediate plaques at nonstented sites (−2.5 ± 3.0 vs +1.0 ± 3.0 mm3/mm, −10% ± 8% vs +9% ± 9%, P < .05). Major adverse events at 12 months were present in 11% and 24% of simvastatin-treated patients and controls, respectively (P = .20). Conclusions: In normocholesterolemic patients undergoing coronary stenting, simvastatin does not prevent intimal hyperplasia or ISR, but it promotes atherosclerotic regression both at stented and at nonstented sites. [Copyright &y& Elsevier]