Sa'ar Minha

Learning curves for transfemoral transcatheter aortic valve replacement in the PARTNER‐I trial: Success and safety

To identify number of cases needed to maximize device success and minimize adverse events after transfemoral transcatheter aortic valve replacement (TF‐TAVR), and determine if adverse events were linked to the technical performance learning curve.

Learning curves for transfemoral transcatheter aortic valve replacement in the PARTNER-I trial: Technical performance.

To assess technical performance learning curves of teams performing transfemoral transcatheter aortic valve replacement (TF‐TAVR).

Two-Year Follow-Up of Outcomes of Second-Generation Everolimus-Eluting Stents Versus First-Generation Drug-Eluting Stents for Stenosis of Saphenous Vein Grafts Used as Aortocoronary Conduits

Second-generation everolimus-eluting stents (EESs) have demonstrated superiority in efficacy and safety compared with first-generation drug-eluting stents (DESs) in the treatment of native coronary artery lesions. The present study evaluated and compared the safety and efficacy of EESs and first-generation DESs in saphenous vein graft lesions. The EES group consisted of 88 patients with 96 lesions, and the first-generation DES group consisted of 243 patients with 317 lesions (sirolimus-eluting stents, n = 212; paclitaxel-eluting stents, n = 105). The end points included target lesion revascularization, target vessel revascularization, major adverse cardiovascular events (composite of all-cause death, myocardial infarction, and target vessel revascularization), and definite stent thrombosis at 2 years. The groups had similar baseline characteristics and graft ages (128.1 ± 77.5 vs 132.4 ± 90.8 months, p = 0.686). The EES group had more type C lesions and less embolic protection device use. The peak postprocedure values of creatinine kinase-MB and troponin I were similar between the 2 groups. Overall, major adverse cardiovascular events occurred in 18.2% of EES patients and 35.0% of first-generation DES patients (p = 0.003), mainly driven by a lower target vessel revascularization rate (6.8% vs 24.5%, p <0.001). The target lesion revascularization rate was lower in the EES group (1.1% vs 11.6%, p = 0.005). Stent thrombosis was low and similar between the 2 groups (0% vs 0.8%, p = 1.000). On multivariate analysis, the type of DES implanted and graft age were the only independent predictors of major adverse cardiovascular events. In conclusion, the superiority of EESs compared with first-generation DESs shown in native artery lesions has been extended to saphenous vein graft lesions and should be considered as the DES of choice for this lesion type.

Prevalence and Impact of Pulmonary Hypertension on Patients With Aortic Stenosis Who Underwent Transcatheter Aortic Valve Replacement

Limited amount of data suggest that patients with aortic stenosis and pulmonary hypertension (PH) who undergo transcatheter aortic valve replacement (TAVR) experience decrease in PH postprocedure. Inconsistent use of systolic pulmonary artery pressure cut-off values in previous studies limits our ability to draw meaningful conclusions regarding the prognostic role of PH in assessment of TAVR candidates. A total of 415 consecutive patients who underwent TAVR were included in the present study. Two groups were compared based on receiver-operating characteristics curve analysis for the best SPAP value to predict outcome, yielding 2 study groups of no/mild PH (≤50 mm Hg; n = 172, 41%) versus moderate/severe PH (>50 mm Hg; n = 243, 59%). Demographics and co-morbidities were comparable between the 2 groups; however, right-sided cardiac failure (35% vs 19.8%, p = 0.02) and mitral regurgitation (18.4% vs 8.6%, p = 0.007) were more frequent in patients with moderate/severe PH. Procedural characteristics and complications were comparable between the groups. Although there was an early overall decrease in SPAP postprocedure, only 26% of moderate/severe patients with PH experienced a significant decrease in SPAP (>10 mm Hg). The 30-day (14.5% vs 7.4%, p = 0.02) and 1-year mortality (30.8% vs 21%, p = 0.02) was higher in moderate/severe patients with PH. In multivariate analysis, systolic pulmonary artery pressure and chronic lung disease were identified as independent predictors for mortality at 1 year. PH is a frequent co-morbidity in patients with severe aortic stenosis who underwent TAVR. Significantly elevated pulmonary artery pressures at baseline may serve as a poor prognostic factor when performing preprocedural assessment of the patients.

Comparison of Adverse Outcomes After Contemporary Percutaneous Coronary Intervention in Women Versus Men With Acute Coronary Syndrome

Previous studies have shown a relation between female gender and adverse outcomes after percutaneous coronary intervention (PCI). The aim of this study was to determine whether there are differences in correlates between genders for these long-term adverse outcomes in patients with acute coronary syndromes. Gender differences were evaluated in the clinical outcomes of 6,929 consecutive patients with acute coronary syndromes from a large, contemporary PCI registry. Rates of major adverse cardiovascular events, defined as all-cause mortality, myocardial infarction, and target lesion revascularization at 1-year follow-up, are reported. Independent correlates of adverse outcomes were identified using multivariate proportional-hazards regression analysis. Women were older (p <0.001); had a higher prevalence of diabetes mellitus (p <0.001), systemic hypertension (p <0.001), chronic renal insufficiency (p = 0.02), peripheral arterial disease (p <0.001), and congestive heart failure (p <0.001); had lower body surface areas (p <0.001); and had higher body mass indexes (p <0.001). Acute coronary syndrome presentation in women tended to be unstable angina pectoris with Canadian Cardiovascular Society class III and IV symptoms, whereas men had more acute myocardial infarctions. At 1 year, the unadjusted rates of all-cause mortality (10.7% vs 7.5%, p <0.001) and major adverse cardiovascular events (16.4% vs 12.7%, p <0.001) were higher in women. There was a stark difference between the genders in independent correlates of mortality and major adverse cardiovascular events at 1 year. Moreover, the traditional correlates did not have the same impact in women as in men. In conclusion, although there are differences in clinical outcomes after PCI for women compared with men, there are different correlates for these adverse outcomes. These gender-based differences should be taken into account when women undergo contemporary PCI.

Predictors and clinical implications of atrial fibrillation in patients with severe aortic stenosis undergoing transcatheter aortic valve implantation

To assess the prevalence at baseline, postprocedural incidence, and clinical impact of atrial fibrillation (AF) on consecutive patients undergoing transcatheter aortic valve implantation (TAVI).

Impact of Previous Coronary Artery Bypass Grafting on Patients Undergoing Transcatheter Aortic Valve Implantation for Aortic Stenosis

Re-operation after coronary artery bypass grafting (CABG) is associated with increased risk for morbidity and mortality. Transcatheter aortic valve implantation (TAVI) is an alternative for patients with aortic stenosis, but the outcomes of patients with a history of CABG are unknown. The aim of this study was to explore the association between previous CABG and the outcome of patients undergoing TAVI. Out of 372 consecutive patients who underwent TAVI from 2007 to 2013, 122 (32.8%) had previous CABG, whereas 250 (67.2%) did not. A comparison was made between groups. Subgroup analysis compared patients with and without previous CABG in 3 patient subsets: inoperable, operable, and those who underwent transapical TAVI. Patients with previous CABG were younger (81.99±6.78 vs 84.81±7.06 years, respectively, p<0.001). These patients also had more high-risk features (e.g., peripheral vascular disease, previous myocardial infarction, past cerebrovascular disease, and lower average left ventricular ejection fraction (p<0.05 for all). Procedural aspects were mostly similar between groups. No disparities in mortality rates at 1 year were noted (22.1% vs 21.6%, respectively, p=0.91). Subgroup analyses yielded similar outcomes for all 3 groups. In conclusion, although patients with previous CABG present with more high-risk features, they share similar short- and long-term outcomes with patients without previous CABG, irrespective of their surgical risk. This includes patients who underwent transapical access. TAVI in patients with previous CABG is safe and does not confer a significant risk for adverse outcome.

Correlation of Brain Natriuretic Peptide Levels in Patients With Severe Aortic Stenosis Undergoing Operative Valve Replacement or Percutaneous Transcatheter Intervention With Clinical, Echocardiographic, and Hemodynamic Factors and Prognosis

Brain natriuretic peptide (BNP) is a marker of systolic and diastolic dysfunction and a strong predictor of mortality in heart failure patients. The present study aimed to assess the relationship of BNP with aortic stenosis (AS) severity and prognosis. The cohort comprised 289 high-risk patients with severe AS who were referred for transcatheter aortic valve implantation. Patients were divided into tertiles based on BNP level: I (n = 96); II (n = 95), and III (n = 98). Group III patients were more symptomatic, had higher Society of Thoracic Surgeons and EuroSCORE scores, and had a greater prevalence of renal failure, atrial fibrillation, and previous myocardial infarction; lower ejection fraction and cardiac output; and higher pulmonary pressure and left ventricular end diastolic pressure. The degree of AS did not differ among the 3 groups. Stepwise forward multiple regression analysis identifies ejection fraction and pulmonary artery systolic pressure as independent correlates with plasma BNP. Mortality rates during a median follow-up of 319 days (range 110 to 655) were significantly lower in Group I compared with Groups II and III, p <0.001. After multivariable adjustment, the strongest correlates for mortality were renal failure (hazard ratio 1.44, p = 0.05) and medical/balloon aortic valvuloplasty (HR 2.2, p <0.001). Mean BNP decreased immediately after balloon aortic valvuloplasty from 1,595 ± 1,229 to 1,252 ± 1,076, p = 0.001 yet increased to 1,609 ± 1,264, p = 0.9 at 1 to 12 months. After surgical aortic valve replacement, there was a nonsignificant, immediate decrease in BNP level from 928 ± 1,221 to 896 ± 1,217, p = 0.77, continuing up to 12 months 533 ± 213, p = 0.08. After transcatheter aortic valve implantation, there was no significant decrease in BNP immediately after the procedure; however, at 1-year follow-up, the mean BNP level decreased significantly from 568 ± 582 to 301 ± 266 pg/dl, p = 0.03. In conclusion, a high BNP level in high-risk patients with severe AS is not an independent marker for higher mortality. BNP level does not appear to be significantly associated with the degree of AS severity but does reflect heart failure status.

The state of the excimer laser for coronary intervention in the drug-eluting stent era

OBJECTIVES This study aims to determine how excimer laser coronary atherectomy (ELCA) performs in the drug-eluting stent (DES) era. BACKGROUND For more than 20 years, ELCA has been used for coronary intervention. With developments in the coronary intervention field, the role of ELCA is in question. METHODS The study includes 119 patients with 124 lesions who underwent percutaneous coronary intervention (PCI) with ELCA in our institution from January 2004 to May 2011. RESULTS The main indications for ELCA use were saphenous vein graft (SVG) (45 lesions), acute myocardial infarction (AMI) (7 lesions), chronic total occlusion (CTO) (32 lesions), in-stent restenosis (ISR) (15 lesions), and calcified de-novo lesions (25 lesions). High success rates were recorded for the SVG, AMI, CTO, ISR, and calcified lesion indications (91.1%, 85.7%, 93.8%, 86.7%, and 80%; respectively). ELCA related complications were reported in 10 patients (8%); four dissections, three no-reflow phenomena, two perforations, and one thrombus formation. CONCLUSION ELCA is an alternative solution with acceptable performance in the treatment of complex coronary lesions not ideally suitable for balloon angioplasty.

Acquired thrombocytopenia after transcatheter aortic valve replacement: clinical correlates and association with outcomes

AIMS This study aimed to evaluate incidence and correlates for low platelet count after transcatheter aortic valve replacement (TAVR) and to determine a possible association between acquired thrombocytopenia and clinical outcomes. METHODS AND RESULTS Patients undergoing TAVR from two medical centres were included in the study. They were stratified according to nadir platelet count post procedure: no/mild thrombocytopenia, ≥100 × 10(9)/L; moderate, 50-99 × 10(9)/L; and severe, <50 × 10(9)/L. A total of 488 patients composed of the study population (age 84.7 ± 7.5 years). At a median time of 2 days after TAVR, 176 patients (36.1%) developed significant thrombocytopenia: 149 (30.5%) moderate; 27 patients (5.5%) severe. Upon discharge, the vast majority of patients (90.2%) had no/mild thrombocytopenia. Nadir platelet count <50 × 10(9)/L was highly specific (96.3%), and a count <150 × 10(9)/L highly sensitive (91.2%), for predicting 30-day death (C-statistic 0.76). Patients with severe acquired thrombocytopenia had a significantly higher mortality rate at 1 year (66.7% for severe vs. 16.0% for no/mild vs. 20.1% for moderate; P < 0.001). In multivariate logistic regression, severe thrombocytopenia was independently associated with 1-year mortality (hazard ratio 3.44, CI: 1.02-11.6; P = 0.046). CONCLUSIONS Acquired thrombocytopenia was common after TAVR and was mostly resolved at patient discharge. The severity of thrombocytopenia after TAVR could be used as an excellent, easily obtainable, marker for worse short- and long-term outcomes after the procedure.