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Limited evidence exists concerning the prognostic impact of baseline left ventricular ejection fraction (LVEF) on outcomes among women undergoing transcatheter aortic valve implantation (TAVI), which we aimed to investigate in the present analysis. Patients from the Women's International Transcatheter Aortic Valve Implantation (WIN-TAVI) registry were categorized according to baseline LVEF into 3 groups: reduced (LVEF ≤40%), mildly reduced (LVEF between 41% and 49%), and preserved (LVEF ≥50%) LVEF. The primary (Valve Academic Research Consortium 2 [VARC-2]) efficacy point was defined as a composite of mortality, stroke, myocardial infarction, hospitalization for valve-related symptoms or heart failure, or valve-related dysfunction at 1 year. The primary (VARC-2) safety end point included all-cause mortality, stroke, major vascular complication, life-threatening bleeding, stage 2 to 3 acute kidney injury, coronary artery obstruction requiring intervention, or valve-related dysfunction requiring repeated procedures. A Cox regression model was performed using the preserved LVEF group as the reference. Among the 944 patients included, 764 (80.9%) exhibited preserved, 80 (8.5%) had mildly reduced, and 100 (10.6%) had reduced LVEF. The 1-year incidence of VARC-2 efficacy end point was numerically higher in patients with reduced LVEF, albeit not resulting in a significant risk difference. Notably, reduced LVEF was associated with a higher risk of the 1-year VARC-2 safety end point, still significant after adjustment (28.0% vs 19.6%, Hazard Ratio 1.78, 95% Confidence Interval 1.12- 2.82, p = 0.014). These differences were primarily driven by trends toward increased rates of all-cause mortality, cardiovascular mortality, and major vascular complications. Clinical outcomes were similar between patients with mildly reduced and preserved LVEF. In conclusion, when performed in women with reduced LVEF, TAVI was associated with a worse (VARC-2) safety profile at 1-year follow-up. In contrast, patients with mildly reduced LVEF appeared to align more closely with outcomes observed in the preserved LVEF group than with the reduced LVEF group., Competing Interests: Declaration of competing interest Dr. Bay is supported by a grant from the German Heart Foundation, grant no. S/06/23. Dr. Petronio received consultancy fees from Medtronic, Abbott, and Boston and funds from Boston and Abbott. Dr. Mehilli received institutional grants from Boston Scientific and lecture fees from AstraZeneca, Bristol-Myers Squibb, Boston Scientific, and Edwards Lifesciences. Dr. Lefèvre proctors for Edwards, Boston, and Abbott. Dr. Sardella received sponsorships from Medtronic in terms of technical training courses and congress assistance. Dr. Van Mieghem received research grant support and advisory fees from Abbott, Boston Scientific, and Medtronic, and research grant support from Edwards Lifesciences. Dr. Dumonteil received proctoring and consultancy fees from Abbott Vascular, Boston Scientific, Edwards Lifesciences, and Medtronic. Dr. Mikhail is the Director of Imperial Valve and Cardiovascular Course, which is supported by several device and pharmaceutical companies; he has received an educational grant from Abbott for an Interventional Fellowship. Dr. Ferrer-Gracia received sponsorships from Medtronic and Edwards companies in terms of technical training courses and congress assistance. Dr. Sharma served on the Speakers Bureau of Abbott Vascular, Boston Scientific, and Cardiovascular Systems, Inc. Dr. Morice is CEO and shareholder of CERC, a CRO based in Massy that had no role in WIN-TAVI. Dr. Dangas received consulting fees from GE Healthcare, Janssen Pharmaceuticals, Inc., and Medtronic, Inc.; <1% equity with Claret Medical and Elixir Medical; delivered industry-sponsored lectures for The Medicines Company; and is on the Scientific Advisory Board of AstraZeneca. Dr. Chieffo received speaker/consultant fees from Abiomed, Abbott Vascular, Biosensor, Cardinal Health, GADA, and Magenta Medical. Dr. Mehran received research grants to the institution from Abbott, Abiomed, Alleviant Medical, AM-Pharma, Amgen, Applied Therapeutics, Arena, AstraZeneca, BAIM, Bayer, Beth Israel Deaconess, Biosensors, Biotronik, Boston Scientific, Bris- tol-Myers Squibb, CardiaWave, CellAegis, CeloNova, CERC, Chiesi, Concept Medical, CSL Behring, Cytosorb- ents, DSI, Duke University, Element Science, Faraday, Humacyte, Idorsia, Insel Gruppe AG, Magenta, Medtronic, Novartis, OrbusNeich, PhaseBio, Philips, RenalPro, Shock- wave, Vivasure, and Zoll and consulting fees from Cine-Med Research, WebMD. The authors have no competing interests to declare., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Advances in personalized medicine and Systems Biology have introduced probabilistic models and error discovery to cardiovascular care, aiding disease prevention and procedural planning. However, clinical application faces cultural, technical, and methodological hurdles. Patient autonomy remains essential, with shared decision-making (SDM) gaining importance in managing complex cardiovascular treatment options. Effective SDM relies on collaboration between providers and patients, guided by P5 Medicine principles, which combine psycho-cognitive considerations with predictive, personalized, preventive, and participatory care. Here we propose a three-step methodological proposal for implementing SDM and enhancing consent acquisition in cardiovascular care. The approach emphasizes personalized patient engagement and the need for clear, comprehensive consent processes. It identifies and addresses significant gaps in current practices, including the complexity of consent language, information dispersion, and the specific needs of vulnerable populations. Issues of Medical Responsibility and/or Liability may raise in the case of absence of consent acquisition or invalid consent due to insufficient/incorrect information. The International Guidelines on Medico-Legal Methods of Ascertainment and Evaluation Criteria are reported. In conclusion, the paper proposes practical solutions, including the use of artificial intelligence (AI) to enhance decision-making and patient counseling, and strategies to ensure that consent processes are both thorough and legally sound and respectful to the individual's autonomy., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Giuseppe Tarantini reports a relationship with Edwards Lifesciences Corporation that includes: speaking and lecture fees. Giuseppe Tarantini reports a relationship with Abbott Vascular Inc that includes: speaking and lecture fees. Giuseppe Tarantini reports a relationship with Medtronic that includes: speaking and lecture fees. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2025. Published by Elsevier Inc.)

Right-sided cardiac catheterization (RHC) is selectively recommended in mitral valve transcatheter edge-to-edge (M-TEER) workup because right ventricle (RV) hemodynamic parameters predict adverse outcomes. This study examines the impact of RV hemodynamics and the prognostic value of the 2022 European Society of Cardiology (ESC) pulmonary hypertension definitions on outcomes after M-TEER. Of 152 patients treated with M-TEER for symptomatic severe mitral regurgitation (MR) between December 2014 and February 2024 at our tertiary center, 71 underwent elective RHC before the procedure. The primary outcomes assessed were all-cause mortality and a composite of heart failure hospitalization and death at the longest available follow-up. In a cohort of 152 mostly male patients (64%) with a median age of 79 years who were treated for symptomatic severe MR, 71 underwent elective RHC. The causes were categorized as degenerative (47%), functional ventricular (41%), and atrial (12%). Pulmonary hypertension (PH) was common, with 74% showing mean pulmonary artery pressure (mPAP) >20 mm Hg and 39% with pulmonary vascular resistance (PVR) >2 Wood Units. Success rates were high, with technical, device, and procedural success at 97%, 88%, and 84%, respectively. At a median follow-up of 681 days, all-cause mortality was 50%, and the composite outcome (death or heart failure hospitalizations) occurred in 61%. Key hemodynamic parameters, including mPAP, PVR, and the tricuspid annular plane systolic excursion/systolic pulmonary artery pressure ratio, were independently linked to mortality risk. Kaplan-Meier analysis found significant associations with mPAP >20 mm Hg and pulmonary capillary wedge pressure >15 mm Hg for long-term mortality, whereas the 2022 ESC PH thresholds showed greater sensitivity, correlating with increased mortality risk. In patients with severe MR who undergo M-TEER, most RV invasive hemodynamic parameters are linked to adverse long-term outcomes, with mPAP, PVR, and the tricuspid annular plane systolic excursion/systolic pulmonary artery pressure ratio identified as independent predictors of mortality. Despite the study's limited sample size, the updated ESC PH definitions enhance prognostic assessment., Competing Interests: Declaration of competing interest Dr. Tarantini reports honoraria for lectures/consulting from Edwards Lifesciences and Abbott Vascular. The remaining authors have no competing interest to declare., (Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)

The prognostic impact of coronary artery disease (CAD) after transcatheter aortic valve implantation (TAVI) is controversial. The aim of this study is to investigate the impact of CAD and different revascularization strategies on clinical outcomes in patients who underwent TAVI with third generation devices. Patients enrolled in the national observational Observational Study of Effectiveness of SAVR-TAVI Procedures for Severe Aortic Stenosis Treatment II study were stratified according to the presence of CAD (CAD+, n = 1,130) versus no CAD (CAD-, n = 1,505), and compared using a propensity matched analysis. CAD+ group was further stratified according to the revascularization strategy: no revascularization (n = 331), revascularization performed >90 days before index-TAVI (n = 417) and coronary revascularization performed <90 days before index-TAVI or during TAVI (n = 382). In-hospital, 30-day and 1-year clinical outcomes were estimated. The mean age of the overall population was 81.8 years; 54.9% of patients were female. Propensity score matching yielded 813 pairs and their 30-day all-cause mortality was comparable (p = 0.480). Major periprocedural adverse events were also similar between the groups. At 1-year follow-up, the rate of major adverse cardiac and cerebrovascular events (MACCEs) and all-cause mortality were similar between the groups (p = 0.732 and p = 0.633, respectively). Conversely, patients with CAD experienced more often myocardial infarction and need for percutaneous coronary intervention at 1 year (p = 0.007 and p = 0.001, respectively). Neither CAD nor revascularization strategy were independent predictors of 1-year MACCE. About 40% of patients presenting with severe AS and who underwent TAVI had concomitant CAD. The presence of CAD had no impact on all-cause mortality and MACCE 1-year after TAVR. However, CAD carries a higher risk for acute myocardial infarction and need of percutaneous coronary intervention during follow-up., Competing Interests: Declaration of Competing Interest Dr. Trani discloses to have been involved in advisory board meetings or having received speaker's fees from Abbott, Abiomed, Medtronic and Biotronic. Dr. Aurigemma has been involved in advisory board activities by Abbott, Abiomed, Medtronic and Daiichi Sankyo. The remaining authors have no competing interests to declare., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Given the increasing population eligible for transcatheter aortic valve implantation (TAVI), resource utilization has become an important focus in this setting. We aimed to estimate the change in the financial burden of TAVI therapy over 2 different periods. A probabilistic Markov model was developed to estimate the cost consequences of increased center experience and the introduction of newer-generation TAVI devices compared with an earlier TAVI period in a cohort of 6,000 patients. The transition probabilities and hospitalization costs were retrieved from the OBSERVANT (Observational Study of Effectiveness of AVR-TAVI procedures for severe Aortic steNosis Treatment) and OBSERVANT II (Observational Study of Effectiveness of TAVI with new generation deVices for severe Aortic stenosis Treatment) studies, including 1,898 patients treated with old-generation devices and 1,417 patients treated with new-generation devices. The propensity score matching resulted in 853 pairs, with well-balanced baseline risk factors. The mean EuroSCORE II (6.6% vs 6.8%, p = 0.76) and the mean age (82.0 vs 82.1 y, p = 0.62) of the early TAVI period and new TAVI period were comparable. The new TAVI period was associated with a significant reduction in rehospitalizations (-30.5% reintervention, -25.2% rehospitalization for major events, and -30.8% rehospitalization for minor events) and a 20% reduction in 1-year mortality. These reductions resulted in significant cost savings over a 1-year period (-€4.1 million in terms of direct costs and -€19.7 million considering the additional cost of the devices). The main cost reduction was estimated for rehospitalization, accounting for 79% of the overall cost reduction (not considering the costs of the devices). In conclusion, the introduction of new-generation TAVI devices, along with increased center experience, led to significant cost savings at 1-year compared with an earlier TAVI period, mainly because of the reduction in rehospitalization costs., Competing Interests: Declaration of Competing Interest Dr. Barbanti is consultant for Boston Scientific, Medtronic, and Edwards Lifesciences. Dr. Tamburino is consultant for Medtronic. The remaining authors have no conflicts of interest to declare., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Early menopause is associated with an increased risk of cardiovascular diseases, including aortic stenosis (AS). We sought to investigate the prevalence and impact of early menopause on clinical outcomes in patients who underwent transcatheter aortic valve implantation (TAVI) for severe symptomatic AS. Women's International TAVI is a multinational, prospective, observational registry of women who underwent TAVI for severe symptomatic AS (n = 1,019). Patients were divided into 2 groups based on age of menopause: early menopause (age ≤45 years) and regular menopause (age >45 years). The primary outcome of interest was Valve Academic Research Consortium 2 efficacy end point, a composite of mortality, stroke, myocardial infarction, hospitalization for valve-related symptoms, or heart failure or valve-related dysfunction at 1-year follow-up. Of 732 patients with available data on menopause age, 173 (23.6%) were classified as having early menopause. These patients presented for TAVI at a younger age (81.6 ± 6.9 vs 82.7 ± 5.9, p = 0.05) and had a significantly lower Society of Thoracic Surgeons score (6.6 ± 4.8 vs 8.2 ± 7.1, p = 0.03) than those with regular menopause. However, the total valve calcium volume was smaller among patients with early versus regular menopause (731.8 ± 850.9 mm 3 vs 807.6 ± 633.8 mm 3 , p = 0.002). Other co-morbidities were similar between the 2 groups. At 1-year follow-up, there were no significant differences in clinical outcomes between patients with early versus regular menopause (hazard ratio 1.00, 95% confidence interval 0.61 to 1.63, p = 1.00). In conclusion, despite presenting for TAVI at a younger age, patients with early menopause had a similar risk of adverse events as patients with regular menopause at 1 year after TAVI., Competing Interests: Disclosures Dr. Chieffo received consultancy fees from Abiomed, Biosensor, Edwards and Shockwave Medical and payments for lecturs from Boston Scientific and Abbot Vascular. Dr. Dangas received a research grant to institution form Daiichi-Sankyo. Dr. Lefèvre received consultancy fees from Edwards, Boston Scientific and Abbot. Dr. Mehran received research grants to the institution from Abbott, Abiomed, Alleviant Medical, AM-Pharma, Amgen, Applied Therapeutics, Arena, AstraZeneca, BAIM, Bayer, Beth Israel Deaconess, Biosensors, Biotronik, Boston Scientific, Bristol-Myers Squibb, CardiaWave, CellAegis, CeloNova, CERC, Chiesi, Concept Medical, CSL Behring, Cytosorbents, DSI, Duke University, Element Science, Faraday, Humacyte, Idorsia, Insel Gruppe AG, Magenta, Medtronic, Novartis, OrbusNeich, PhaseBio, Philips, RenalPro, Shockwave, Vivasure, Zoll, consulting fees from Cine-Med Research, WebMD. Dr. Morice is CEO and shareholder of CERC, a CRO not involved in this trial. Dr. Petronio received consultancy fees from Medtronic, Abbott, Boston Scientific, and funds from Boston Scientific and Abbott. Dr. Spirito received a research grant from the Swiss National Science Foundation. Dr. Van Mieghem received research grants from Abbott, Boston Scientific, Edwards Lifesciences, Medtronic, Abiomed, PulseCath BV, Daiichi Sankyo, Pie Medical. Dr Watanabe is a clinical proctor of TAVR for Edwards Lifesciences and Medtronic. The other authors have no relevant disclosures., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Although most patients with small aortic annulus are women, there is paucity of data on the prognostic impact of small aortic prosthesis in women who underwent transcatheter aortic valve implantation (TAVI). Therefore, we aimed to evaluate the impact of small valve size on 1-year clinical outcomes after TAVI in women. The Women's INternational Transcatheter Aortic Valve Implantation is an all-women registry evaluating patients with severe aortic stenosis who underwent TAVI. Based on the size of the aortic bioprosthesis implanted, women were stratified into small (≤23 mm) and nonsmall (>23 mm) valve. The primary efficacy endpoint was the Valve Academic Research Consortium-2 composite of all-cause death, stroke, myocardial infarction, hospitalization for valve-related symptoms or heart failure or valve-related dysfunction at 1-year follow-up. Of 934 women who underwent TAVI, 388 (41.5%) received a small valve. Women with a small valve size had a lower body mass index, lower surgical risk scores, were less likely to suffer from atrial fibrillation, less often required postdilation and had a lower rate of residual aortic regurgitation grade ≥2. The occurrence of the Valve Academic Research Consortium-2 efficacy endpoint was similar between women treated with small and nonsmall valve (16.0% vs 16.3%, p = 0.881; adjusted hazard ratio 1.34, 95% confidence interval 0.90 to 2.00). Likewise, there were no significant differences in the occurrence of other secondary endpoints after multivariable adjustment. In conclusion, women with severe aortic stenosis who underwent TAVI with the implantation of a small valve bioprosthesis had similar 1-year outcomes as those receiving a nonsmall bioprosthesis., (Copyright © 2022 Elsevier Inc. All rights reserved.)

We sought to analyze outcomes of women receiving balloon-expandable valves (BEV) or self-expanding valves (SEV) in contemporary transcatheter aortic valve implantation (TAVI). WIN TAVI (Women's INternational Transcatheter Aortic Valve Implantation) is the first all-female TAVI registry to study the safety and performance of TAVI in women. We compared women treated with BEV (n = 408, 46.9%) versus those treated with SEV (n = 461, 53.1%). The primary efficacy end point was the Valve Academic Research Consortium-2 (VARC-2) composite of 1-year all-cause death, stroke, myocardial infarction, hospitalization for valve-related symptoms or heart failure or valve-related dysfunction. Women receiving SEV had higher surgical risk scores, higher rate of previous stroke and pulmonary hypertension whereas women receiving BEV were more frequently denied surgical valve replacement due to frailty. BEV patients were less likely to require post-dilation and had significantly lower rates of residual aortic regurgitation grade ≥2 (9.8% vs 4.7%, p = 0.007). At 1 year, the crude incidence and adjusted risk of the primary VARC-2 efficacy end point was similar between groups (17.1% with SEV and 14.3% with BEV, p = 0.25; hazards ratio 1.09, 95% confidence interval 0.68 to 1.75). Conversely the crude rate and adjusted risk of new pacemaker implantation was higher with SEV than BEV (15% vs 8.6%, p = 0.001; hazards ratio 1.97, 95% confidence interval 1.13 to 3.43). A subanalysis on new generation valves showed no difference in the need for pacemaker implantation between the 2 devices (10.1% vs 8.0%, p = 0.56). In conclusion, in contemporary TAVI, SEV are used more frequently in women with greater co-morbidities. While there were no differences in unadjusted and adjusted risk of 1-year primary efficacy end point between the valve types, there was a greater need for permanent pacemakers after SEV implantation., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Pre-existing atrial fibrillation (AF) is common among patients who underwent transcatheter aortic valve implantation (TAVI) and has been associated with adverse outcomes. The specific impact of AF at baseline in women who underwent TAVI, however, remains unknown. The Women's International Transcatheter Aortic Valve Implantation is a prospective, multinational registry evaluating the safety and performance of contemporary TAVI in women in 19 centers between January 2013 and December 2015. Patients with available electrocardiogram at baseline were compared according to the presence of AF. All events were adjudicated according to the Valve Academic Research Consortium 2 criteria. Associations between AF and outcomes were tested using multivariate Cox regression model. Of the 993 women with available baseline electrocardiogram included in the study, 200 (20.1%) presented with AF. Patients with AF at baseline had higher Euroscore I score values and more frequently had chronic kidney disease or prior stroke. Patients without AF more frequently had coronary artery disease. There was no difference regarding in-hospital events between the two groups aside from longer length of stay for patients with AF (13.3 ± 11 vs 11.5 ± 7.1 days, p = 0.01). In multivariate analysis, AF at baseline was associated with an increase of all-cause and cardiovascular death at 12 months ( adj HR 1.67 95%CI 1.11 to 2.50, p = 0.013 and adj HR 1.85 95%CI 1.19 to 2.86, p = 0.006 respectively). In conclusion, in this prospective registry of women who underwent contemporary TAVI, the presence of AF at baseline was associated with significantly increased 12-month mortality., (Copyright © 2018. Published by Elsevier Inc.)

The aim of this study was to analyze procedural and postprocedural outcomes of patients aged ≥80 years treated by transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (SAVR) as enrolled in the OBservational Study of Effectiveness of SAVR-TAVR procedures for severe Aortic steNosis Treatment (OBSERVANT) Study. TAVI is offered to patients with aortic stenosis judged inoperable or at high surgical risk. Nevertheless, it is common clinical practice to treat elderly (≥80 years) patients by TAVI regardless of surgical risk for traditional SAVR. OBSERVANT is a multicenter, observational, prospective cohort study that enrolled patients with symptomatic severe aortic stenosis who underwent SAVR or TAVI from December 2010 to June 2012 in 93 Italian participating hospitals. Information on demographic characteristics, health status before intervention, therapeutic approach, and intraprocedural and 30-day outcomes was collected. An administrative follow-up was set up to collect data on midterm to long-term outcomes. We reviewed baseline and procedural data of patients aged ≥80 years, looking for different early and late outcome after TAVI or SAVR. Patients treated by TAVI were sicker than SAVR because of higher rate of co-morbidities, advanced illness, frailty, and Logistic EuroSCORE. After propensity matching, early and midterm mortality were comparable between the 2 groups. However, patients treated by TAVI had higher rate of vascular complications (6.0% vs 0.5%; p <0.0001), permanent pacemaker implantation (13.4% vs 3.7%; p <0.0001), and paravalvular leak (8.9% vs 2.4%; p <0.0001). Patients who underwent SAVR had more frequent bleedings needing transfusion (63.2% vs 34.5%; p <0.0001) and acute kidney injury (9.6% vs 3.9%; p = 0.0010). In conclusion, patients aged ≥80 years treated by TAVI or SAVR had similar early and midterm mortality., (Copyright © 2016 Elsevier Inc. All rights reserved.)

This study aims to develop and validate a new angiographic risk score to predict the risk of distal embolization (DE) during primary percutaneous coronary intervention (p-PCI) for ST-elevation myocardial infarction. Study included data from 1,200 patients who underwent p-PCI. The cohort was randomly split into a derivation cohort (n = 814) and a validation cohort (n = 386). Logistic regression was used to examine the relation between risk factors and the occurrence of DE. To each covariate in the model was assigned an integer score based on the regression coefficients. Variables included in the risk score, according to multivariable analysis, were occlusion pattern of infarct-related artery, Thrombolysis In Myocardial Infarction Thrombus Score 2 to 4, reference vessel diameter ≥3.5 mm, and lesion length >20 mm. To each variable was assigned a 0- to +2-point score according to the strength of the statistical association. Rates of DE in low-, intermediate-, and high-risk groups were 5.6%, 15.8%, and 40% in the derivation cohort (p for trend <0.0001; C-statistic 0.70) and 7.5%, 12.1%, and 37.9% in the validation cohort (p for trend <0.0001; C-statistic 0.62), respectively. In conclusion, the individual risk of DE in patients who underwent p-PCI can be predicted using a simple 4-variables model based on angiographic features., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Two different devices, 1 self-expanding and 1 balloon-expandable, have been developed for patients who underwent transcatheter aortic valve implantation with contrasting data about efficacy and safety. Pubmed, Medline, and Google Scholar were systematically searched for studies of these different devices, with data derived from randomized controlled trial or registries with multivariate analysis. All-cause death at 30 days and at follow-up were the primary end points, whereas postprocedural moderate or severe aortic regurgitation (AR), stroke, major vascular complications, bleedings, and pacemaker implantation the secondary ones. Six studies with 957 self-expanding and 947 balloon-expandable valves were included: 1 randomized controlled trial and 5 observational studies. At 30 days follow-up, rates of death did not differ between self-expanding and balloon-expandable valves (odds ratio [OR] 0.74, 95% confidence interval [CI] 0.47 to 1.17), whereas balloon expandable reduced rates of moderate or severe AR (OR 0.51, 95% CI 0.27 to 0.99) and of pacemaker implantation (OR 0.28, 95% CI 0.17 to 0.47). After a follow-up of 360 days (300 to 390), rates of all-cause death did not differ between the 2 groups. In conclusion, risks of moderate or severe AR and pacemaker implantation were lower with the balloon-expandable devices without an impact on 30 days and midterm mortality., (Copyright © 2015 Elsevier Inc. All rights reserved.)

A relevant proportion of patients, classified as severe aortic stenosis on the basis of valve area ≤1 cm(2), have a mean transvalvular gradient ≤40 mm Hg, despite a preserved left ventricular ejection fraction (LGSAS). We assessed the clinical and hemodynamic impact of transcatheter aortic valve implantation in patients with symptomatic LGSAS at high risk for surgery or inoperable, according to the type of percutaneous valve implanted. Ninety-five patients received an Edwards SAPIEN valve (Edwards Lifesciences, Irvine, California) and 51 received a Medtronic CoreValve (Medtronic, Inc., Minneapolis, Minnesota). The hemodynamic performance of the 2 valves was similar in term of final transvalvular gradients (10 mm Hg, p = 0.069). Early mortality rate was 7% and was not different between the 2 valves (p = 0.73). During follow-up, cardiovascular mortality rate was similar between groups, and valve type was not a predictor of outcome (p = 0.72). Estimated survival by Kaplan-Meier at 2 years was 70%. At multivariate analysis, life-threatening or major bleeding, postprocedural aortic insufficiency, and acute kidney injury were the major predictors of an adverse outcome. In patients with LGSAS treated by transcatheter aortic valve implantation, the use of balloon-expandable versus self-expandable valves resulted in similar hemodynamic, early, and long-term clinical outcomes., (Copyright © 2015 Elsevier Inc. All rights reserved.)

The purpose of this study was to analyze the relation of aortic valve weight to transvalvular gradient and area, with special regard to valve anatomy, size of calcific deposits, gender, and body size. Two hundred forty-two surgically excised stenotic aortic valves of patients (139 men, mean age 72 ± 9 years) who had undergone preoperative cardiac catheterization and echocardiography were weighed and examined with respect to number of cusps (tricuspid vs bicuspid), size of calcium deposits (microaggregates vs nodular macroaggregates), and presence of cholesterol clefts. The relation among valve weight, gradient, and area was studied. Transvalvular gradient was independent of gender or valve anatomy and was linearly correlated with valve weight absolutely (r = 0.33, p <0.01) or normalized by body surface area (r = 0.40, p <0.01). No correlation was evident between valve area and weight. Calcium macroaggregates were mainly present in men (51%) and in bicuspid valves (67%) and were seen to be strong determinants of valve weight (2.84 ± 1.03 g with macroaggregates vs 1.63 ± 0.56 g with microaggregates, p <0.001) but not of transvalvular gradient. Calcium microaggregates characterized tricuspid valves (62%), where transvalvular gradient was determined by valve weight (p = 0.0026). In conclusion, the heavier the valve, the less frequent were hypercholesterolemia, valve cholesterol clefts, hypertension, and diabetes mellitus., (Copyright © 2011 Elsevier Inc. All rights reserved.)

The aims of the present study were to investigate the incidence and characteristics of conduction disorders (CDs) after transcatheter aortic valve implantation (TAVI), to analyze the predictors of permanent pacemaker (PPM) implantation, and to evaluate the outcomes of CDs over time. In particular, we sought to investigate whether the depth of deployment and other technical aspects of valve implantation might predict the need for PPM implantation after TAVI. TAVI has been reported to favor the onset or worsening of CDs often requiring PPM implantation. A total of 70 patients with aortic stenosis due to dystrophic calcification underwent TAVI with third-generation CoreValve Revalving System from May 2007 to April 2009. We collected electrocardiograms at baseline, during TAVI, during hospitalization and at the 1-, 3-, 6-, and 12-month follow-up visits thereafter. The clinical, anatomic, and procedural variables were tested to identify the predictors of PPM implantation. The PPM dependency at follow-up was analyzed. Six patients were excluded from the analysis because of a pre-existing PPM. Of the 64 patients, 32 (50%) had one or more atrioventricular-intraventricular CDs at baseline. TAVI induced a worsening in the CDs in 49 (77%) of the 64 patients, with 25 (39%) requiring in-hospital PPM implantation. On multivariate analysis, the independent predictors of PPM implantation were the depth of the prosthesis implantation (p = 0.039) and the pre-existing right bundle branch block (p = 0.046). A trend in the recovery of the CDs over time was recorded, although 2 patients required PPM implantation 1 month after discharge for late complete atrioventricular block. In conclusion, TAVI often induces or worsens CDs, requiring PPM in more than one third of patients, although a trend in the recovery of CDs during the midterm was recorded. The independent predictors of PPM implantation were the depth of prosthesis implantation and pre-existing right bundle branch block., (Copyright © 2011 Elsevier Inc. All rights reserved.)

The aim of this study was to evaluate the impact of age on immediate- and long-term outcomes of percutaneous mitral balloon valvuloplasty (PMV). PMV is the first-line treatment for patients with symptomatic mitral stenosis. However, long-term results in large series of patients from Europe and the United States have been found less favorable than those from Asia and South America involving younger patients. Six hundred ten patients who underwent 626 PMV procedures were prospectively followed for 6.1 +/- 4.10 years using clinical and echocardiographic evaluation. Patients were divided in quartiles according to age: < or =41 years (n = 163), 42 to 53 years (n = 163), 54 to 63 years (n = 142), and >63 years (n = 158). The success of PMV was defined as valve area > or =1.5 cm(2) without severe regurgitation; restenosis was defined as a loss > or =50% of initial gain, with a valve area of <1.5 cm(2). PMV success was significantly more prevalent in younger patients: 95.7% in group 1, 91.4% in group 2, 86.4% in group 3, and 83.4% in group 4 (p = 0.002). No significant differences in complications were found among all age groups, including death, cardiac tamponade, emergency mitral replacement, and any embolic events (p = NS). Event-free survival was greater in younger patients (p <0.0001), but on multivariate analysis, age was not an independent predictor of events (p = NS). Restenosis occurred in 27.9% of patients, throughout all groups (p = NS). In conclusion, PMV may be safely and effectively performed in younger and older patients. Although event-free survival was greater in younger groups, multivariate analysis did not find that age was an independent predictor of events.