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Although antithrombotic treatment is recommended after left atrial appendage closure (LAAC), some patients require discontinuation of antithrombotic treatment after LAAC without evidence on the safety of such a strategy. We sought to evaluate outcomes of patients who had early antithrombotic treatment discontinuation after LAAC. This is a multicenter study including 1,082 patients who underwent successful LAAC. Early discontinuation of antithrombotic treatment was defined as discontinuation of all antiplatelet/anticoagulant treatment within 6 months following the procedure. A propensity-matched analysis was used to compare outcomes of patients with and without early antithrombotic treatment discontinuation. A total of 148 patients (13.7%) had early antithrombotic treatment discontinuation. In the entire population, antithrombotic treatment discontinuation patients exhibited a lower CHA(2)DS(2)-VASc score (p

Limited data exist on patients with a transient ischemic attack (TIA) who underwent patent foramen ovale (PFO) closure. The objectives of this study were to determine the clinical and procedural characteristics and long-term outcomes of patients with TIA who underwent transcatheter PFO closure. This was a multicenter study including 1,012 consecutive patients who underwent PFO closure after a cerebrovascular event. Patients were divided into 2 groups according to their index event leading to PFO closure: TIA (n = 183 [18%]), and stroke (n = 829 [82%]). The median follow-up was 3 (2 to 8) years (complete in 98% of patients). There were no significant differences between patients with TIA and stroke, except for a lower Risk of Paradoxical Embolism score in the TIA group (6.1 vs 6.9 in the stroke group, p0.001). PFO closure was successful in all patients with a low rate of complications (1%) in both groups. There were no differences in the incidence of neurologic events during long-term follow-up. There was 1 stroke event in the TIA group and 6 in the stroke group (0.08 vs 0.17 per 100 patients-years, p = 0.584). There were 2 TIA events in the TIA group and 10 in the stroke group (0.17 vs 0.28 per 100 patients-years, p = 0.557). In conclusion, our study showed that patients with TIA who underwent PFO closure have similar clinical characteristics as patients with stroke including a high Risk of Paradoxical Embolism score. Furthermore, these results suggest that PFO closure procedural results and long-term clinical outcomes are similar to their stroke counterparts, with a very low incidence of recurrent neurologic events. Further prospective randomized clinical trials are needed on this population.

This study sought to determine, in patients with new-onset persistent left bundle branch block (NOP-LBBB) after transcatheter aortic valve implantation (TAVI), the incidence and factors associated with (i) LBBB recovery and (ii) permanent pacemaker implantation (PPI) at 1-year follow-up. This was a multicenter study including 153 patients (mean age: 81 ± 5 years, 56% of women) with NOP-LBBB post-TAVI (balloon-expandable valve in 112 patients). Delta PR (ΔPR) and delta QRS (ΔQRS) were defined as the difference in PR and QRS length between baseline and hospital discharge ECG, and the relative ΔPR and ΔQRS as absolute ΔPR and ΔQRS divided by baseline PR and QRS length, respectively. The patients had a clinical visit and 12-lead ECG at 1-year follow-up. LBBB recovery was observed in 50 patients (33%), and 14 patients (9%) had advanced conduction disturbances requiring PPI during the follow-up period. No clinical or ECG variables were associated with LBBB recovery, including prosthesis type (self- or balloon-expandable valve, p = 0.563), QRS width at baseline/discharge or absolute/relative ΔQRS (p >0.10 for all). The presence of atrial fibrillation at baseline (0.026), a longer PR interval at discharge (0.009), and a longer absolute and relative ΔPR (p = 0.002 and p = 0.004, respectively) were associated with an increased risk of PPI at 1-year follow-up. In conclusion, NOP-LBBB post-TAVI resolved in one-third of patients at 1-year follow-up, but no clinical or ECG variables were associated with LBBB recovery. Conversely, a nonsinus rhythm at baseline and a longer ΔPR were associated with an increased risk of PPI within the year after TAVI.

Few data exist on late vascular complications (VCs) after transfemoral (TF) transcatheter aortic valve implantation (TAVI). The objective of this study was to evaluate the incidence and predictors of late access site VC after TF TAVI. A total of 128 patients (mean age: 80 ± 8 years, women: 52%) who underwent TF TAVI without major VC were included. A femoral US-Doppler evaluation was performed in all patients at a median of 5 (3 to 15) months after the procedure, and 76 patients (59.4%) also had a preprocedural ultrasound (US)-Doppler examination. The impact of baseline and procedural factors (including the use of simple 2 Proglides or complex additional Proglide or Angioseal device on top of the 2 Proglide technique, hemostasis techniques, and the use of balloon dilation for optimizing femoral hemostasis) were evaluated. The follow-up US-Doppler evaluation detected 2 asymptomatic VCs (1.6%), and 5 (3.9%) patients exhibited significant femoral stenosis (peak systolic velocity [PSV] ≥300 cm/s). Female gender (p0.001) and smaller femoral diameter (p = 0.045) were associated with higher femoral PSV values. In those patients who underwent a pre-TAVI femoral US-Doppler, the median PSV values after TAVI were higher compared with those obtained pre-TAVI (p0.001), but similar results were found for the contralateral femoral arteries. A complex hemostasis technique or the use of balloon optimization at the puncture site was not associated with any increase in PSV values. In conclusion, percutaneous femoral hemostasis after TAVI was associated with a low rate of late VC. The results were similar irrespective of the hemostasis technique and the use of balloon dilation at the puncture site, but women and a smaller femoral size were associated with increased PSV values. Further studies are needed to determine the optimal femoral hemostasis technique in TAVI procedures.

Scarce data support the prescription of oral anticoagulation in patients with concomitant advanced chronic kidney disease (CKD) and atrial fibrillation, and left atrial appendage closure (LAAC) may provide a favorable risk-benefit ratio in this population. However, outcomes of LAAC in CKD patients are unknown. We aimed to investigate the impact of moderate-to-severe CKD on clinical outcomes following percutaneous LAAC. This was a multicenter study including 1094 patients who underwent LAAC. Moderate-to-severe CKD was defined as an eGFR45 mL/min. Death, ischemic stroke, severe bleeding (≥BARC 3a) and serious adverse event (SAE; composite of death, stroke or severe bleeding) were recorded. A total of 300 patients (27.4%) had moderate-to-severe CKD. There were no differences between groups in periprocedural complications or device related thrombosis. At a median follow-up of 2 (1 to 3) years, patients with moderate-to-severe CKD did not present an increased risk of ischemic stroke (hazard ratio [HR]: 0.65; 95% confidence interval [CI]: 0.22 to 1.92; p = 0.435) but were at a higher risk of death (HR: 2.84; 95% CI: 2.22 to 3.64; p0.001), severe bleeding (HR: 1.96; 95% CI: 1.36 to 2.81; p0.001) and SAE (HR: 2.23; 95% CI: 1.80 to 2.77; p0.001). By multivariable analysis, an eGFR45 ml/min (HR: 1.92; 95% CI: 1.34 to 2.76; p0.001) and previous bleeding (HR: 2.30; 95% CI: 1.27 to 4.17; p = 0.006) were associated with an increased risk of severe bleeding. In conclusion, patients with moderate-to-severe CKD who underwent LAAC had very high thrombotic and bleeding risks. Although the rates of device related thrombosis or ischemic stroke after-LAAC were not influenced by kidney dysfunction, patients with moderate-to-severe CKD remained at higher risk of severe bleeding events.

We aimed to compare the early (in-hospital/30-day) outcomes (major periprocedural complications, device success/valve performance, and mortality) following transcatheter aortic valve implantation with the Sapien 3 versus Evolut transcatheter valve systems. This was a systematic review from PubMed and EMBASE databases for studies reporting raw data or estimates. The outcomes analyzed were (1) in-hospital/30-day major periprocedural complications, (2) device success and valve performance, and (3) mortality. The outcomes were defined according to VARC-2 criteria. A total of 24,628 transcatheter aortic valve implantation patients from 9 studies (1 randomized, 8 observational [5 case- or propensity-matched analyses]) were included: 12,411 and 12,217 patients had Sapien 3 and Evolut valve implantation, respectively. There were no differences between devices regarding in-hospital/30-day stroke (risk ratio [RR] 0.95, 95% confidence interval [CI] 0.34 to 2.66), major vascular complications (RR 1.03, 95% CI 0.63 to 1.68), acute kidney injury (RR 1.17, 95% CI 0.78 to 1.77), device success (RR 1.00, 95% CI 0.97 to 1.04) and moderate-severe residual aortic regurgitation (RR 0.49, 95% CI 0.20 to 1.17). Sapien 3 recipients exhibited lower risk of permanent pacemaker implantation (RR 0.66, 95% CI 0.55 to 0.80), a higher risk of life-threatening bleeding (RR 1.82, 95% CI 1.18 to 2.80), and higher residual transvalvular gradients (mean difference 3.95 mmHg, 95% CI 3.37 to 4.56). A lower risk of in-hospital/30-day mortality was observed for Sapien 3 (RR 0.79, 95% CI 0.69 to 0.90). In conclusion, the similarities in device success rate and major periprocedural complications (except for a higher and lower risk of permanent pacemaker implantation and life-threatening bleeding, respectively, with the Evolut system) support the lack of a valve type effect accounting for the increased mortality risk observed with the Evolut valve.

To compare dual antiplatelet therapy (DAPT) versus single antiplatelet therapy (SAPT) as antithrombotic treatment after transcatheter aortic valve implantation (TAVI) for the prevention of ischemic events, vascular and bleeding events, and death. Data from the 3 randomized trials comparing DAPT versus SAPT post-TAVI were pooled and analyzed in a patient-level meta-analysis. The primary end point was the occurrence of death, major or life-threatening bleedings, and major vascular complications at 30-day follow-up. Events were adjudicated according to the Valve Academic Research Consortium 2 definitions. A total of 421 patients randomized to DAPT (210 patients) or SAPT (211 patients) post-TAVI were analyzed. There were no differences between groups in baseline clinical and procedural characteristics. The occurrence of the 30-day combined primary end point was higher in the DAPT group (17.6% vs 10.9%, odds ratio 1.73, 95% confidence interval 1.00 to 2.98, p = 0.050), with an increased rate of major or life-threatening bleeding events in the DAPT group (11.4% vs 5.2%, odds ratio 2.24, 95% confidence interval 1.12 to 4.46, p = 0.022). There were no differences between DAPT and SAPT groups in the incidence of death (5.2% vs 3.8%, p = 0.477), global ischemic events (3.8% vs 3.8%, p = 0.999), or stroke (2.4% vs 2.4%, p = 0.996). DAPT (vs SAPT) was associated with a higher rate of major adverse events after TAVI, mainly driven by an increased risk of major or life-threatening bleeding complications along with a lack of beneficial effect on ischemic events. These results do not support the current recommendation of DAPT as antithrombotic therapy after TAVI.

The recommendations for antithrombotic treatment after left atrial appendage closure (LAAC) remain empirical, and no data exist on the changes in hemostatic markers associated with LACC. The objective of the present study is to determine the presence, degree, and timing of changes in the markers of platelet and coagulation activation after LAAC. Forty-three patients (mean age 76 ± 9 years, 23 men) with atrial fibrillation who underwent successful LACC with the Watchman (n = 27) or Amplatzer Cardiac Plug (n = 16) devices were included in the study. Patients received antiplatelet therapy after LAAC (aspirin + clopidogrel: 27 patients; single antiplatelet therapy with aspirin or clopidogrel: 16 patients). Prothrombin fragment 1+2 and thrombin-antithrombin III were used as markers of coagulation activation, and soluble P-selectin and soluble CD40 ligand were used as markers of platelet activation. Measurements of all hemostatic markers were performed at baseline just before the procedure, followed by days 7, 30, and 180 after LAAC. Prothrombin fragment 1+2 and thrombin-antithrombin levels increased from 0.27 nmol/L and 4.68 ng/ml, respectively, at baseline to peak values of 0.43 nmol/L and 9.76 ng/ml, respectively, at 7 days, partially returning to baseline levels at days 30 and 180 after LAAC (p

This study aimed to compare the hemodynamic performance of transcatheter and surgical aortic valves in patients with severe symptomatic aortic stenosis and small aortic annulus (SAA) and to determine the valve hemodynamics according to transcatheter valve type. Consecutive surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR) patients with SAA were case-matched (1:1) on the basis of sex, body surface area, aortic annulus diameter, and left ventricular ejection fraction. A total of 357 patients in each group constituted the final study population. A second match on the basis of aortic annulus diameter and valve/annulus calcium burden was performed within the TAVR group to compare the valve performance between balloon- (n = 52) and self-expanding (n = 52) transcatheter valve systems (BEV, SEV). The echocardiograms performed at hospital discharge were used for evaluating valve hemodynamics. The mean annulus diameter of the study population was 19.2 ± 0.3 mm. The TAVR group (vs SAVR) exhibited lower mean gradient (12 ± 7 mm Hg vs 15 ± 6 mm Hg, p0.001), larger effective orifice area (1.46 ± 0.39 cm

Cardiovascular magnetic resonance (CMR) has demonstrated a high accuracy for evaluating the severity of aortic regurgitation (AR). However, scarce data exist on the impact of AR as evaluated by CMR on clinical outcomes following transcatheter aortic valve implantation (TAVI). The objective of this study was to evaluate the impact of AR as determined by CMR on clinical outcomes (mortality, heart failure [HF] hospitalization) post-TAVI. A total of 448 TAVI recipients from 2 centers (mean age: 80 ± 7 years, mean STS: 5.8 ± 5.4%) who survived the periprocedural period with no pacemaker implantation were included. A newer generation transcatheter valve system was used in 213 patients (48%). The CMR examination was performed at a median of 12 (IQR: 7 to 21) days post-TAVI. After a mean follow-up of 24 ± 19 months, a total of 94 patients (21%) had died and 72 patients (16%) had at least 1 hospitalization because of decompensated HF. The aortic regurgitation fraction (RF) as determined by CMR was an independent predictor of mortality (hazard ratio[HR]:1.06 for each increase of 10%, 95% confidence interval [CI]: 1.01 to 1.12, p = 0.03) and HF hospitalization (HR:1.15 for each increase of 10%, 95% CI:1.02 to 1.30, p = 0.02). The rate of moderate-severe CMR-AR defined as a RF ≥30% was 3%, and this was associated with an increased risk of mortality (HR: 2.63, 95% CI: 2.30 to 2.99, p0.001) and HF hospitalization (HR: 2.96, 95% CI: 1.62 to 5.42, p ˂0.001). A stepwise increase in the risk of mortality and HF hospitalization was observed with an increase in AR severity, with a peak increase among patients with RF ≥30%. In conclusion, our results showed the clinical usefulness of evaluating AR severity by CMR post-TAVI. CMR would be particularly helpful in doubtful cases or those with discordances between echocardiography and clinical data.

Body composition (fat mass [FM] and skeletal muscle mass [SMM]) predicts clinical outcomes. In particular, loss of SMM (sarcopenia) is associated with frailty and mortality. There are no data on the prevalence and impact of FM and SMM in patients undergoing transcatheter aortic valve implantation (TAVI). The objective of this study is to determine body composition from pre-TAVI computed tomography (CT) and evaluate its association with clinical outcomes in patients who underwent TAVI. A total of 460 patients (mean age 81 ± 8 years, men: 51%) were included. Pre-TAVI CTs of the aorto-ilio-femoral axis were analyzed for FM and SMM cross-sectional area at the level of the third lumbar vertebrae (L3). Regression equations correlating cross-sectional area at L3 to total body FM and SMM were used to determine prevalence of sarcopenia, obesity, and sarcopenic obesity in patients (64%, 65%, and 46%, respectively). Most TAVI procedures were performed through a transfemoral approach (59%) using a balloon-expandable valve (94%). The 30-day and mid-term (median 12 months [interquartile range 6 to 27]) mortality rates were 6.1% and 29.6%, respectively. FM had no association with clinical outcomes, but sarcopenia predicted cumulative mortality (hazard ratio 1.55, 95% confidence interval 1.02 to 2.36, p = 0.04). In conclusion, body composition analysis from pre-TAVI CT is feasible. Sarcopenia, obesity, and sarcopenic obesity are prevalent in the TAVI population, with sarcopenia predictive of cumulative mortality.

No data exist on the optimal duration of antithrombotic therapy (AT) following patent foramen ovale (PFO) closure. We sought to assess the safety of AT discontinuation following PFO closure in patients with a cryptogenic ischemic event. A total of 453 consecutive patients (mean age: 48 ± 13years, men: 51%) who underwent PFO closure due to a cryptogenic ischemic event were included. All patients were on AT following PFO closure (antiplatelet therapy: 92.7%, anticoagulation: 7.3%). Ischemic and bleeding events, and AT were assessed at a median follow-up of 8 (IQR: 4 to 11) years, and follow-up was complete in 96% of patients. Stroke and transient ischemic attack occurred in 4 (0.9%) and 12 (2.6%) patients, respectively, and 27 (6.0%) patients had bleeding events (major in 6 [1.3%] patients, including 4 episodes of intracranial hemorrhage). All major bleeding events occurred under aspirin therapy. A total of 82 patients (18%) stopped the AT at a median of 7 (IQR: 5 to 34) months post-PFO closure (due to a bleeding event or gastrointestinal symptoms: 13 patients, no specific reason: 69 patients), and none of them had any ischemic event after a median time of 7 (IQR 3 to 10) years without any AT. A propensity score matched analysis including 46 patients who discontinued the AT within 1-year post-PFO closure and 120 patients with an ongoing AT showed the lack of differences in ischemic events between groups (0 vs 0.2 stroke/transient ischemic attack per 100 patient-years in the no-AT and AT groups, respectively). In conclusion, in young patients who underwent PFO closure, bleeding events occurred in ∼6% of patients after a median follow-up of 8years. AT was discontinued in about one fifth of patients (most of them within the year following PFO closure), and this was not associated with any increase in ischemic events at long-term follow-up. These results suggest that, in patients without other co-morbidities increasing the risk of stroke, temporary AT following PFO closure may be a reasonable strategy.

Controversial data exist on clinical outcomes of patients with paradoxical low-flow, low-gradient aortic stenosis (PLF-LG-AS) undergoing valve replacement. The objective of this study was to determine the clinical outcomes and treatment futility in patients with paradoxical low-flow (PLF), low-gradient (LG) severe aortic stenosis (AS) undergoing transcatheter aortic valve implantation (TAVI). A total of 493 patients with severe symptomatic AS and preserved ejection fraction (>50%) undergoing TAVI were included. Patients were divided in two groups: high gradient AS group (HG-AS; mean gradient ≥40 mm Hg and stroke volume index >35 ml/m2, n = 396); and PLF, LG AS group (PLF-LG-AS; mean AV gradient

The objectives of this study were to determine the causes and impact of anemia and hemoglobin level on functional status, physical performance, and quality of life in the preprocedural evaluation and follow-up of transcatheter aortic valve replacement (TAVR) candidates. A total of 438 patients who underwent TAVR were included. Anemia was defined as a hemoglobin level12 g/dl in women and13 g/dl in men. Before TAVR, anemia was encountered in 282 patients (64.4%). A potential treatable cause of anemia was detected in 90.4% of patients and was attributed to iron deficiency in 53% of them. The occurrence of anemia was an independent predictor of poorer performance in the 6-minute walk test (6MWT), a lower Duke Activity Status Index score, and Kansas City Cardiomyopathy Questionnaires overall, clinical, and social limitation scores (p0.05 for all). A lower hemoglobin level was associated with a higher prevalence of New York Heart Association class III to IV (p0.001) and correlated negatively with the results of all functional tests (p0.02 for all). At follow-up, anemia was found in 62% of patients and was associated with poorer performance in the 6MWT (p = 0.023). A lower hemoglobin level after TAVR was a predictor of poorer New York Heart Association class (p = 0.020) and correlated negatively with the distance walked in the 6MWT (r = -0.191, p = 0.004) and Duke Activity Status Index score (r = -0.158, p = 0.011) at 6-month follow-up. In conclusion, anemia was very common in TAVR candidates and was attributed to iron deficiency in more than half of them. The presence of anemia and lower hemoglobin levels determined poorer functional status before and after the TAVR procedure. These results highlight the importance of implementing appropriate measures for the diagnosis and treatment of this frequent co-morbidity to improve both the accuracy of preprocedural evaluation and outcomes of TAVR candidates.

The objective of this study was to evaluate the impact of diffuse coronary atherosclerosis on the functional evaluation of moderate coronary lesions in the proximal-mid segment of a coronary artery and its clinical implications. This was a prospective study including 100 consecutive patients with a moderate lesion (45 ± 9% diameter stenosis) in the proximal-mid coronary segment who were evaluated with fractional flow reserve (FFR) measurement. No patient had any other angiographic stenosis distal to the evaluated coronary stenosis. FFR measurements were obtained just distal (~2 to 3 cm) to the lesion (FFR proximal measurement [FFR-PM]) and as distally as possible in the artery (FFR distal measurement [FFR-DM]) after administration of the same dose of intracoronary adenosine. Thirty-nine patients underwent dipyridamole or exercise myocardial single-photon emission computed tomography within 3 months of the FFR study. Mean FFR-PM was significantly higher compared to FFR-DM (0.84 ± 0.08 vs 0.78 ± 0.09, median gradient 0.06, 25th to 75th interquartile range 0.02 to 0.10, p0.0001). FFR-DM was0.75 in 33% of patients with FFR-PM ≥0.75, leading to the decision of revascularization in these patients. Performing FFR measurement in the left main/left anterior descending artery predicted a higher gradient between FFR-DM and FFR-PM (odds ratio 4.58, 95% confidence interval 1.4 to 15.03, p = 0.007). FFR-DM exhibited a better correlation with results of myocardial single-photon emission computed tomography compared to FFR-PM (kappa 0.33 vs 0.22, p0.0001). In conclusion, significant differences between FFR-DM and FFR-PM were observed in patients with moderate coronary stenosis in the proximal-mid segment of a coronary artery, with FFR-DM exhibiting a better correlation with results of noninvasive functional tests. These differences influenced the treatment decision in about 1/3 of patients and highlight the potential clinical relevance of coronary pressure wire positioning for functional evaluation of lesions in the proximal-mid segment of the coronary arteries.

Anemia and major bleeding are independent predictors of outcomes after acute coronary syndromes and percutaneous coronary intervention (PCI). Although the transradial approach reduces the incidence of bleeding, the hemoglobin changes after transradial PCI have not been defined. We serially assessed the hemoglobin values before and after transradial PCI and evaluated the effect of hemoglobin changes on outcomes. In the EArly Discharge After Transradial Stenting of CoronarY Arteries (EASY) trial, 1,348 patients underwent transradial PCI. All patients received aspirin, clopidogrel, and a bolus of abciximab before PCI. The hemoglobin values were assessed immediately before and 4 to 6 hours and 12 to 24 hours after PCI. The major adverse cardiac events (death, myocardial infarction, and target vessel revascularization) were assessedor =3 years after PCI. According to the World Health Organization classification, 206 patients (15%) had anemia before PCI and 410 (30%) developed anemia within 24 hours after PCI. A mean hemoglobin decrease of 0.6 +/- 1.0 g/dl occurred within 24 hours after PCI. At 30 days, the major adverse cardiac events were significantly increased when the hemoglobin decrease within 24 hours after PCI was3 g/dl (p = 0.0002). Patients with anemia within 24 hours after PCI had significantly more major adverse cardiac events at 30 days, 6 months, 1 year, and 3 years than patients without anemia (log-rank p = 0.0044). After adjustment for differences in the baseline characteristics, anemia within 24 hours after PCI remained an independent predictor of major averse cardiac events at 3 years (hazard ratio 1.30, 95% confidence interval 1.01 to 1.67, p = 0.045). In conclusion, within 24 hours after transradial PCI with maximal antiplatelet therapy, only a mild hemoglobin decrease was observed. The choice of a hemoglobin decrease3 g/dl after PCI as a cutoff value for current definitions of major bleeding in modern PCI trials appears reasonable. Measures to prevent anemia and blood loss during PCI remain to be further studied.

The optimal value of activated clotting time (ACT) during percutaneous coronary intervention (PCI) with unfractionated heparin remains controversial. No data are available on the relation between the ACT at the end of the procedure (final ACT) and the clinical outcomes after transradial PCI and maximal antiplatelet therapy. By dividing the final ACT values in tertiles, we analyzed the ischemic and bleeding events in 1,234 consecutive patients with acute coronary syndrome recruited in the EArly Discharge after Transradial Stenting of CoronarY Arteries (EASY) trial. All patients were pretreated with aspirin and clopidogrel. After radial sheath insertion, patients received 70 IU/kg unfractionated heparin. Abciximab was given before the first balloon inflation. The median final ACT value was 312 seconds (interquartile range 279 to 344). At 30 days, the rate of major adverse cardiac events, including death, myocardial infarction, and target vessel revascularization, from the lower to upper tertiles was 4%, 4%, and 2%, respectively (p = 0.16), and the rate of major bleeding was 2%, 1% and 0.7%, respectively (p = 0.20). During the 3 years of follow-up, the incidence of myocardial infarction was less in the tertile with the greatest ACT value (>330 seconds) than in the other 2 tertiles (4%, 8%, and 8%, respectively; p = 0.038). Troponin-T and creatine kinase-MB release after PCI indicated that the effect was related to periprocedural myonecrosis protection. After adjustment for baseline and procedural differences, a final ACT of >330 seconds remained associated with a 47% relative reduction in myocardial infarction (odds ratio 0.53, 95% confidence interval 0.29 to 0.93, p = 0.024). Death and target vessel revascularization remained similar in all tertiles for ≤3 years. In conclusion, with the combination of aspirin, clopidogrel pretreatment, and abciximab, a final ACT value of >330 seconds appears protective against peri-PCI myonecrosis, and this benefit was maintained for ≤3 years. With a transradial approach and maximal antiplatelet therapy, greater ACT values did not correlate with an increased risk of bleeding.

The objectives of this study were to evaluate the usefulness of fractional flow reserve (FFR) measurements to guide the clinical decision in patients with intermediate left main coronary artery (LMCA) stenosis and to determine the predictors of major adverse cardiac events (MACE) -- cardiac death, myocardial infarction, coronary revascularization -- in such cases; 142 consecutive patients with intermediate LMCA stenosis (mean percent diameter stenosis 42 +/- 13%) were included. All patients underwent FFR measurement after intracoronary administration of adenosine at a doseor =30 microg. The clinical decisions were based on FFR as follows: coronary revascularization was recommended if FFR was0.75, medical treatment if FFR was0.80, and individualized decision based on additional clinical data if FFR was between 0.75 and 0.80. Mean FFR was 0.81 +/- 0.09 after the administration of 176 +/- 99 microg of adenosine. Based on FFR results, 60 patients (42%) underwent coronary revascularization, and 82 patients (58%) received medical treatment. At 14 +/- 11 months follow-up, the incidence of MACE related to the LMCA stenosis was 13% in the medical treatment group and 7% in the revascularization group (p = 0.27). The incidence of cardiac death or myocardial infarction was 6% in the medical treatment group and 7% in the revascularization group (p = 0.70). In the medical treatment group, with MACE had received a lower dose of intracoronary adenosine (86 +/- 57 vs 167 +/- 102 microg; odds ratio 1.39 for each decrease of 30 microg of intracoronary adenosine, 95% confidence interval 1.02 to 1.89) and more frequently had diabetes (55% vs 21%; odds ratio 4.40, 95% confidence interval 1.17 to 16.42). In conclusion, FFR measurement is helpful in guiding the decision whether to revascularize patients with intermediate LMCA stenosis. However, patients with diabetes remain at higher risk, and higher doses than previously recommended of intracoronary adenosine might have to be used in the evaluation of LMCA stenosis.

There are currently no data evaluating the hematologic and biocompatibility profile of transcatheter aortic valves in vivo. We evaluated the incidence, predictive factors, and clinical consequences associated with hemolysis post-transcatheter aortic valve implantation (TAVI). A total of 122 patients who underwent TAVI with a balloon-expandable valve were included. Baseline blood sampling and echocardiography, followed by early post-TAVI echocardiography and repeat blood sampling, at 6 to 12 months post-TAVI were performed. Hemolysis post-TAVI was defined according to the established criteria. The incidence of hemolysis post-TAVI was 14.8% yet no patient experienced severe hemolytic anemia requiring transfusion. Compared with the nonhemolysis group, those with hemolysis demonstrated significant reductions in hemoglobin (p = 0.012), were more frequently women (67% vs 34%, p = 0.016), and had a higher incidence of post-TAVI severe prosthesis-patient mismatch (PPM) (44% vs 17%, p = 0.026). The rate of mild or more prosthetic valve regurgitation did not significantly differ between those patients with and without hemolysis (56% vs 37%, p = 0.44). Wall shear rate (WSR) and energy loss index (ELI), both indirect measures of shear stress, were higher (p = 0.039) and lower (p = 0.004), respectively, in those patients with hemolysis. Increasing PPM severity was also associated with significant stepwise WSR increments and ELI decrements (p0.01 for both). In conclusion, subclinical hemolysis occurred in 15% of patients following TAVI. Although prosthetic valve regurgitation had no impact on hemolysis, a novel association between PPM and hemolysis was found, likely driven by higher shear stress as determined by WSR and ELI. These hematologic and biomechanical findings may have long-term clinical implications and could affect future transcatheter aortic valve design.

This study determined the safety of deferring coronary revascularization based on a fractional flow reserve (FFR) valueor = 0.75 in a series of consecutive unselected coronary patients with moderate coronary lesions, including patients with unstable angina, myocardial infarction (MI), and/or positive noninvasive test findings. The study included 201 consecutive coronary patients (mean age 62 +/- 10 years; 65% men) with 231 lesions evaluated by FFR measurement for which revascularization was deferred based on a FFR valueor = 0.75. Lesions associated with a positive noninvasive test result were those located in an artery supplying a myocardial territory in which myocardial ischemia was demonstrated by a noninvasive test. Cardiac events (cardiac death, MI, revascularization) and Canadian Cardiovascular Society angina class were evaluated at follow-up. Indications for coronary angiography included unstable angina or MI (62%), stable angina (30%), or atypical chest pain (8%). Forty-four patients (22%) hador = 1 coronary lesion associated with a positive noninvasive test result in which FFR was evaluated. Mean FFR value was 0.87 +/- 0.06 and mean lesion percent diameter stenosis was 41 +/- 8%. At 11 +/- 6 months of follow-up, cardiac events occurred in 20 patients (10%), and no significant differences were observed between patients with unstable angina or MI and those with stable angina (9% vs 13%, p = 0.44) or between patients with and without lesions associated with positive noninvasive test results (9% vs 10%, p = 1.00). At the end of follow-up, 88% of patients were asymptomatic in angina class 0 or I, with no differences across various groups. In conclusion, these results suggest that patients with moderate coronary lesions can be safely managed without revascularization on the basis of FFR measurements, irrespective of clinical presentation and/or presence of positive noninvasive test results.

Several studies have demonstrated a correlation between myocardial ischemia and severity of coronary lesions as determined by intravascular ultrasound (IVUS) and fractional flow reserve (FFR) measurements. However, their value for the assessment of mild coronary stenoses that are associated with myocardial perfusion abnormalities has not been well studied. The objective of this study was to prospectively compare the results of myocardial perfusion as determined by exercise/dipyridamole myocardial single-photon emission computed tomography with IVUS and FFR measurements in patients who had angiographically mild coronary stenosis (50% diameter stenosis by quantitative coronary angiography). Forty-eight patients who had stable coronary disease (61 +/- 11 years of age; 6 women) were included. All had mild coronary stenosis in the proximal/middle segment ofor = 1 coronary artery and had undergone maximal exercise myocardial technetium-99m tetrofosmin single-photon emission computed tomography within 48 hours before coronary angiography. IVUS measurements included lesion lumen area, external elastic membrane area, lesion plaque burden (calculated as external elastic membrane minus lumen area, divided by external elastic membrane, and multiplied by 100), and lumen area stenosis (calculated as reference lumen area minus lesion lumen area, divided by reference lumen area, multiplied by 100). Fifty-three coronary lesions were studied, with a mean percent diameter stenosis of 34.9 +/- 7.9% on angiography. Myocardial perfusion defects were demonstrated by single-photon emission computed tomography in 11 patients (12 myocardial regions) with no differences in lesion percent diameter stenosis compared with those without perfusion defects. The presence of reversible perfusion defects was associated with a higher lesion plaque burden as evaluated by IVUS (67.4 +/- 8.1% vs 60.2 +/- 9.3%, p = 0.01). FFR values did not differ in the presence or absence of perfusion defects (0.90 +/- 0.06 vs 0.92 +/- 0.07, respectively; p = NS). In conclusion, plaque burden as determined by IVUS may partly explain the presence of myocardial perfusion defects in cases of angiographically nonsignificant coronary lesions. However, the high FFR values associated with these lesions suggest that other mechanisms, such as endothelial/microvascular dysfunction, might also account for perfusion abnormalities in these patients.

A 47-year-old man was referred because of an acute anterolateral ST-segment elevation myocardial infarction. Coronary angiography showed marked ectasia of the coronary arteries, with no obstructive lesions. Ventriculography strongly suggested severe left ventricular hypertrophy, later confirmed by cardiovascular magnetic resonance imaging. Complete clinical investigation showed that the patient also had multiple lentigines, ocular hypertelorism, and deafness. These associations led to the diagnosis of LEOPARD (Lentigines, Electrocardiographic anomalies, Ocular hypertelorism, Pulmonary stenosis, Anomalies of the genitalia, Retarded growth, and Deafness [sensorineural]) syndrome. Although uncommon, LEOPARD syndrome is important to recognize because it can be associated with serious adverse cardiac events, particularly in patients with severe left ventricular hypertrophy.

No data exist on the impact of vascular complications related to the secondary access site in transcatheter aortic valve implantation (TAVI). The objectives of this nonrandomized study were to determine the rate of vascular complications related to the secondary access site in TAVI procedures and to evaluate the clinical impact of using the radial versus femoral approach as a secondary access in such procedures. A total of 462 consecutive patients (mean age 79 ± 9 years, 50% men) who underwent TAVI were included. The femoral approach (FA) was used as the secondary access (for the insertion of a 5F pigtail catheter) in 335 patients and the radial approach (RA) in 127 patients. Thirty-day events were prospectively collected. There were no baseline differences between groups, except for a higher prevalence of women and peripheral disease in the FA group (p0.05 for both). A total of 74 vascular access site complications occurred in 70 patients (15%), and 23% of them (29% in the FA group) were related to the secondary access. The use of FA as secondary access was associated with a higher rate of vascular complications (5.0% vs 0% in the RA group, p = 0.005, adjusted p = 0.014). All major vascular complications related to the secondary access occurred in the FA group (3% vs 0% in the RA group, p = 0.040, adjusted p = 0.049), and this translated into a higher rate of major and/or life-threatening bleeding events related to the secondary access in the FA group (3% vs 0% in the RA group, p = 0.040, adjusted p = 0.049). In conclusion, about 1/4 of vascular access site complications in TAVI are related to the secondary access. The use of the RA as a secondary access was associated with a major reduction in vascular complications. These results highlight the impact of secondary access vascular complications in TAVI procedures and support the use of the RA as the preferred secondary access.

The SAPIEN 3 valve (S3V) is a new-generation transcatheter valve with enhanced anti-paravalvular leak properties, but no data comparing with earlier transcatheter valve systems are available. We aimed to compare the hemodynamic performance of the S3V and the SAPIEN XT valve (SXTV) in a case-matched study with echo core laboratory analysis. A total of 27 patients who underwent transcatheter aortic valve replacement (TAVR) with the S3V were matched for prosthesis size (26 mm), aortic annulus area, and mean diameter measured by computed tomography, left ventricular ejection fraction, body surface area, and body mass index with 50 patients treated with the SXTV. The prosthesis size was determined by oversizing of 1% to 15% of annulus area. Doppler echocardiographic images collected at baseline and 1-month follow-up were analyzed in a central echocardiography core laboratory. The need for postdilation was higher in the SXTV group (20% vs 4%, p = 0.047), and mean residual gradient and effective orifice area were similar in both groups (p >0.05). The incidence of paravalvular aortic regurgitation was greater with the SXTV (≥mild: 42%, moderate: 8%) than with the S3V (≥mild: 7%, moderate: 0%; p = 0.002 for ≥mild vs SXTV). The implantation of an S3V was the only factor associated with trace or no paravalvular leak after TAVR (p = 0.007). In conclusion, TAVR with the S3V was associated with a very low rate of paravalvular leaks and need for balloon postdilation, much lower than that observed with the earlier generation of balloon-expandable valve (SXTV). The confirmation of these results in a larger cohort of patients will represent a major step forward in using transcatheter valves for the treatment of aortic stenosis.

Transcatheter aortic valve implantation with the self-expandable CoreValve (CV) and the balloon-expandable Edwards SAPIEN (ES) bioprostheses has been widely used for the treatment of severe aortic stenosis. However, a direct comparison of the hemodynamic results associated with these 2 prostheses is lacking. The aim of the present study was to compare the hemodynamic performance of both bioprostheses. A total of 41 patients who underwent transcatheter aortic valve implantation with the CV prosthesis were matched 1:1 for prosthesis size (26 mm), aortic annulus size, left ventricular ejection fraction, body surface area, and body mass index with patients who underwent transcatheter aortic valve implantation with the ES prosthesis. Doppler-echocardiographic data were prospectively collected before the intervention and at hospital discharge, and all examinations were sent to, and analyzed in, a central echocardiography core laboratory. The mean transprosthetic residual gradient was lower (p = 0.024) in the CV group (7.9 ± 3.1 mm Hg) than in the ES group (9.7 ± 3.8 mm Hg). The effective orifice area tended to be greater in the CV group (1.58 ± 0.31 cm(2) vs 1.49 ± 0.24 cm(2), p = 0.10). The incidence of severe prosthesis-patient mismatch was, however, similar between the 2 groups (effective orifice area indexed to the body surface area ≤0.65 cm(2)/m(2); CV 9.8%, ES 9.8%, p = 1.0). The incidence of paravalvular aortic regurgitation was greater with the CV (grade 1 or more in 85.4%, grade 2 or more in 39%) than with the ES (grade 1 or more in 58.5%, grade 2 or more in 22%; p = 0.001). The number and extent of paravalvular leaks were greater in the CV group (p0.01 for both comparisons). In conclusion, transcatheter aortic valve implantation with the CV prosthesis was associated with a lower residual gradient but a greater rate of paravalvular aortic regurgitation compared to the ES prosthesis. The potential clinical consequences of the differences in hemodynamic performance between these transcatheter heart valves needs to be addressed in future studies.

Bivalirudin, a direct thrombin inhibitor, has been shown to reduce major bleeding and provide a better safety profile compared to unfractionated heparin (UFH) in patients undergoing percutaneous coronary intervention (PCI) through transfemoral access. Data pertaining to the clinical benefit of bivalirudin compared to UFH monotherapy in patients undergoing transradial PCI are lacking. The present study sought to compare the in-hospital net clinical adverse events, including death, myocardial infarction, target vessel revascularization, and bleeding, for these 2 antithrombotic regimens for all patients at a tertiary care, high-volume radial center. From April 2009 to February 2011, all patients treated with bivalirudin were matched by access site to those receiving UFH. The patients in the bivalirudin group (n = 125) were older (72 ± 13 years vs 66 ± 11 years; p

Transcatheter aortic valve implantation (TAVI) is invariably associated with the risk of clinically manifest transient or irreversible neurologic impairment. We sought to investigate the incidence and causes of clinically manifest stroke during TAVI. A total of 214 consecutive patients underwent TAVI with the Medtronic-CoreValve System from November 2005 to September 2011 at our institution. Stroke was defined according to the Valve Academic Research Consortium recommendations. Its cause was established by analyzing the point of onset of symptoms, correlating the symptoms with the computed tomography-detected defects in the brain, and analyzing the presence of potential coexisting causes of stroke, in addition to a multivariate analysis to determine the independent predictors. Stroke occurred in 19 patients (9%) and was major in 10 (5%), minor in 3 (1%), and transient (transient ischemic attack) in 6 (3%). The onset of symptoms was early (24 hours) in 11(58%). Brain computed tomography showed a cortical infarct in 8 patients (42%), a lacunar infarct in 5 (26%), hemorrhage in (5%), and no abnormalities in 5 (26%). Independent determinants of stroke were new-onset atrial fibrillation after TAVI (odds ratio 4.4, 95% confidence interval 1.2 to 15.6), and baseline aortic regurgitation grade III or greater (odds ratio 3.2, 95% confidence interval 1.1 to 9.3). In conclusion, the incidence of stroke was 9%, of which >1/2 occurred >24 hours after the procedure. New-onset atrial fibrillation was associated with a 4.4-fold increased risk of stroke. In conclusion, these findings indicate that improvements in postoperative care after TAVI are equally, if not more, important for the reduction of periprocedural stroke than preventive measures during the procedure. (C) 2012 Elsevier Inc. All rights reserved. (Am J Cardiol 2012;109:1637-1643)

Few data exist on the use of the 6-minute walk test (6MWT) to measure the exercise capacity of patients with severe symptomatic aortic stenosis considered at very high surgical risk. The objectives of the present prospective study were (1) to determine the feasibility and safety of the 6MWT as a measure of exercise capacity before and after transcatheter aortic valve implantation (TAVI), and (2) to determine the clinical and hemodynamic parameters associated with the exercise capacity changes in such patients. A total of 64 patients (age 80 ± 8 years, logistic European System for Cardiac Operative Risk Evaluation score 21 ± 15%, Society of Thoracic Surgeons' score 7.5 ± 3.9%) who had undergone successful TAVI were included. The 6MWT was performed within the month before TAVI and at the 6-month follow-up visit. The mean distance walked increased from 165.3 ± 79.7 to 231.7 ± 88.9 m (p0.0001); however, up to 25% of the patients did not improve or even decreased their exercise capacity. After adjustment for the baseline distance walked, multilinear regression analysis showed that a greater degree of renal dysfunction, as evaluated by the serum creatinine levels (r(2) = 0.05, p = 0.03), lower postprocedural hemoglobin values (r(2) = 0.13, p = 0.0012), and a longer hospitalization length (r(2) = 0.08, p = 0.007) were associated with lower improvement in exercise capacity. In conclusion, exercise capacity, as evaluated by the 6MWT, was very poor in patients with severe symptomatic aortic stenosis considered at very high surgical risk. TAVI was associated with a significant increase in exercise capacity, although no improvement was observed in 1/4 of the patients. A greater degree in renal dysfunction, lower postprocedural hemoglobin values, and longer hospitalization stay were predictors of lower improvement in exercise capacity after TAVI. These results suggest that the 6MWT might become an important tool as a part of the evaluation process for TAVI candidates.

Platelet aggregation inhibition (PAI) ofor =95% has been associated with improved outcomes after percutaneous coronary intervention (PCI) and glycoprotein IIb/IIIa inhibitor treatment. A greater thrombotic burden in acute ST-segment elevation myocardial infarction (STEMI) might require higher doses and/or intracoronary delivery of glycoprotein IIb/IIIa inhibitors to achieve optimal PAI. Using a 2 x 2 factorial placebo-controlled design, 105 patients with STEMI who had been referred for primary PCI within 6 hours of symptom onset were randomized to intracoronary (IC) or intravenous (IV) delivery of an abciximab bolus at a standard dose (0.25 mg/kg) or high dose (or =0.30 mg/kg) of abciximab. The primary end point was PAI measured at 10 minutes after the bolus of abciximab. Secondary end points included the acute and 6-month outcomes using angiographic parameters, cardiac biomarkers, cardiovascular magnetic resonance imaging, and clinical end points. At 10 minutes after the bolus, the proportion of patients withor =95% PAI was not different between the IC and IV groups (53% vs 54%, p = 1.00) nor between the high-dose and standard-dose bolus groups (56% vs 51%, p = 0.70). Acutely, the angiographic myocardial blush grades, peak release of cardiac biomarkers, necrosis size, myocardial perfusion, and no reflow as assessed by magnetic resonance imaging, and clinical end points were similar between the groups and did not suggest a benefit for IC compared to IV or high-dose versus standard-dose bolus of abciximab. No increase occurred in bleeding complications with the high-dose bolus or IC delivery. The clinical, angiographic and cardiac magnetic resonance imaging outcomes at 6 and 12 months were similar between the 4 groups. In conclusion, in patients with STEMI presenting with symptom onset6 hours and undergoing transradial primary PCI, PAI remained suboptimal, despite a higher dose bolus of abciximab. A higher dose bolus or IC delivery of abciximab bolus was not associated with improved acute or late results compared to the standard IV dosing and administration.

Elderly patients are at a higher risk for complications after percutaneous coronary intervention (PCI) when performed through the femoral approach. The impact of age on complications in patients treated using the transradial approach is not known. The bleeding and ischemic outcomes at 30 days, 6 months, 1 year, and 3 years after transradial PCI and maximal antiplatelet therapy were compared in 1,348 patients aged70 oror =70 years with acute coronary syndromes. All patients received aspirin and clopidogrel before catheterization, followed by abciximab at the time of PCI. Patients agedor =70 years (n = 259 [19%]) had more hypertension, dyslipidemia, family histories, and previous coronary artery bypass grafting. Older patients had lower baseline hemoglobin, platelet, and creatinine clearance values, and they also more often had 2- or 3-vessel syndrome (p = 0.001), as well as longer procedure durations (p = 0.024). At 30 days, the rates of major adverse cardiac events and major bleeding were similar in older and younger patients. Only the incidence of gastrointestinal bleeding (p = 0.021) and mild to moderate access-site hematoma were higher in older patients (p = 0.036). The rates of major adverse cardiac events were also similar in the 2 age groups at 6 months (6% vs 9%, p = 0.08), 1 year (10% vs 13%, p = 0.22), and 3 years (19% vs 20%, p = 0.73), but mortality was significantly higher at 3 years in patients agedor =70 years (p = 0.0031). In conclusion, age per se is not a predictor of major adverse cardiac events or major bleeding after transradial PCI with maximal antiplatelet therapy. However, older patients remain more prone to gastrointestinal bleeding and local hematoma compared to younger patients, and preventive measures need to be further investigated.

No data exist on the acute effects of statin therapy on human coronary atherosclerotic plaques. The objective of our study was to evaluate the early (2 months) effects of newly initiated statin therapy on coronary atherosclerosis as evaluated by intravascular ultrasonography. The study population consisted of 74 patients (mean age 58 +/- 8 years) who had been included in the ERASE trial (evaluating the effects of reconstituted high-density lipoprotein infusions). All patients underwent serial intravascular ultrasonographic (IVUS) evaluation at baseline (3 +/- 2 days after an acute coronary syndrome [ACS]) and after 6 +/- 1 weeks of follow-up. Statin therapy was initiated after ACS in 36 patients who receivedor =1 dose of statins before baseline IVUS examination (newly initiated statin therapy group), and 38 patients were already on a stable statin dose before the ACS (long-term statin therapy group). Atorvastatin at a dose of 40 mg/day was the most common regimen in the 2 groups. Percent changes in atheroma volume (prespecified primary efficacy parameter) were -4.71 +/- 0.96% in the newly initiated statin therapy group (p0.0001) and -0.54 +/- 0.89% in the long-term statin therapy group (p = 0.546; p = 0.002 for comparison between groups). Median nominal changes in atheroma volume were -9.10 mm(3) (interquartile range -12.56 to -3.73, p0.0001 vs baseline) and 1.21 mm(3) (interquartile range -6.41 to 3.76, p = 0.429 vs baseline) in the newly initiated and long-term statin therapy groups, respectively (p = 0.003 for comparison between groups). Greater decreases in total cholesterol (r = 0.25, p = 0.035), ratio of total to high-density lipoprotein cholesterol (r = 0.28, p = 0.018), and high-sensitivity C-reactive protein (r = 0.31, p = 0.046, for patients with high-sensitivity C-reactive protein measurements within 7 days after IVUS examination) were associated with larger percent changes in atheroma volume. In conclusion, newly initiated statin therapy is associated with rapid regression of coronary atherosclerosis within 2 months. This effect was in part associated with decreases in atherogenic lipid and inflammatory parameters. These results provide insight into the rapid clinical benefits of statin therapy after an ACS.

The purpose of this study was to evaluate the feasibility and initial results of a multidisciplinary percutaneous aortic valve implantation (PAVI) program including the transfemoral approach (TFA) and the transapical approach (TAA). This was a prospective registry including all patients with symptomatic severe aortic stenosis who were evaluated for PAVI and those who finally underwent the procedure. All patients were considered very high risk or nonsurgical candidates, and an algorithm based on prespecified criteria was used to determine the most appropriate approach (TFA vs TAA) for each patient. The Edwards-Sapien valve was used in all cases, and all procedures were performed without cardiopulmonary bypass. A total of 29 consecutive patients were evaluated for PAVI, and 22 of them underwent the procedure (mean age 84 +/- 7 years, predicted surgical mortality 26 +/- 16%), with 11 patients selected for each approach. Reasons for selecting TAA rather than TFA were the following: small diameter and/or severe calcification of the iliofemoral arteries (4 patients), peripheral vascular disease (4 patients), porcelain aorta (2 patients), and horizontal ascending aorta (1 patient). Successful aortic valve implantation was obtained in 91% of the procedures, and procedural and 30-day mortality were 4.3% and 8.7%, respectively. There were no cases of myocardial infarction, vascular complications, or cerebrovascular accident. PAVI was associated with a significant reduction in mean aortic gradient (baseline 34 +/- 10 mm Hg, postprocedure 9 +/- 3 mm Hg, p0.001), with no cases of severe aortic regurgitation. After a median follow-up period of 6 months, there were no additional major adverse cardiac events, and no significant changes in hemodynamic aortic valve parameters were observed. In conclusion, this study demonstrates the feasibility and low complication rate of a PAVI program using a prospective strategy for the selection of the TFA or TAA, with half of the patients selected for each approach.

The objectives of this study were to evaluate the incidence, predictive factors, and duration of migraine headache attack (MHA) after transcatheter atrial septal defect (ASD) or patent foramen ovale (PFO) closure. A total of 260 consecutive patients who underwent ASD or PFO closure in our center answered a structured headache questionnaire focused in 3 period times, including (1) at baseline (just before closure), (2) within the 3 months after ASD-PFO closure, and (3) at the last (median 27 months, range 6 to 80 months) follow-up. All questionnaires were evaluated by a neurologist who established the diagnosis of MHA with or without aura, according to International Headache Society criteria. The Amplatzer ASD or PFO device was used in 95% of the patients, and aspirin, for at least 6 months, was the antithrombotic treatment in 91% of the cases. A total of 185 patients (71%) had no history of MHA before ASD-PFO closure, and these constituted the study population (mean age 39 +/- 21 years). MHA occurred in 13 patients (7%) after ASD-PFO closure, with aura in 9 of them. MHA appeared after a median of 10 days (range 0.3 to 30 days) after the procedure and were still present at the last follow-up (23 +/- 17 months) in 9 patients (69%). The median number of MHA within the 3 months after the procedure was 4 per month (interquartile range 1 to 23), and decreased to 1 per month (interquartile range 0.3 to 1) at the latest follow-up (p = 0.03). Compared with the patients who did not develop MHA, patients with MHA after ASD-PFO closure were younger (26 +/- 16 vs 39 +/- 21 years; p = 0.02) and were more likely to have undergone ASD closure (100% vs 58%; p = 0.001). In the multivariate analysis, ASD closure was the only predictor of MHA occurrence after the procedure (odds ratio 7.7; 95% confidence interval 1.5 to 22; p = 0.01). In conclusion, MHA, mostly with aura, occurred in 7% of patients after transcatheter ASD-PFO closure and persisted in most of them after a mean follow-up of 2 years. ASD closure was the only independent predictor of MHA occurrence after the procedure. These results suggest that mechanisms other than device composition are involved in the occurrence of MHA in these cases.

The objective of this study was to evaluate the clinical and angiographic factors associated with significant saphenous vein graft (SVG) atherosclerosis progression at mid-term follow-up in a series of unselected coronary patients who had previously received a coronary artery bypass graft (CABG). A total of 123 SVGs from 86 patients who underwent cardiac catheterization twice, 15 +/- 12 months apart, were included in the study. None of the SVGs presented anyor =50% diameter stenosis (DS) lesion or underwent any intervention at baseline. All SVGs were divided into 3 segments and each SVG segment was scored from 0 to 3 depending on the presence of lesions, with percent DS ranging from 0% to 19% (score 0), 20% to 29% (score 1), 30% to 39% (score 2), andor =40% (score 3). The SVG atherosclerotic burden score (ABS) was calculated by adding the score obtained for each of the 3 SVG segments. Significant progression was defined asor =10% increase in lesion percent DS oror =0.6 mm decrease in minimal lumen diameter between baseline and follow-up studies. Mean age of the study population was 66 +/- 9 years, and most of the patients were receiving statin therapy with mean low-density lipoprotein cholesterol of 85 +/- 26 mg/dl. Significant angiographic progression occurred inor =1 SVG in 41 patients (48%). On multivariate analysis, the variables associated with SVG atherosclerosis progression were SVG ABS (odds ratio [OR], 1.52 for each increase of 1 point in SVG ABS; 95% confidence interval [CI] 1.1 to 2.29) and high-density lipoprotein (HDL) cholesterol (OR 1.38 for each decrease of 5 mg/dl in HDL cholesterol levels, 95% CI 1.09 to 1.85). Twenty-two patients (26%) had a cardiac event at follow-up related to SVG disease progression. The percent DS of the SVG segment at baseline was associated with SVG disease progression leading to a cardiac event (OR 3.67 for each increase of 5% in percent DS, 95% CI 2.11 to 6.38). In conclusion, simple clinical and angiographic variables such as HDL cholesterol, ABS, and lesion severity remain independent predictors of significant SVG atherosclerosis progression in mild to moderately diseased SVGs despite mean low-density lipoprotein levels90 mg/dl.