Long-term results and durability of the CoreValve transcatheter aortic bioprosthesis: outcomes beyond five years.

AIMS: The aim of this study was to determine the long-term outcomes of high-risk patients who underwent transcatheter aortic valve implantation (TAVI) with the third-generation CoreValve device, according to the 2017 EAPCI/ESC/EACTS definition of valve durability. METHODS AND RESULTS: Between 2007 and 2013, 278 consecutive patients were enrolled in our prospective single-centre CoreValve registry (mean age 82±6 years, mean STS score 6.4±5.0%). The median follow-up of survivors was 6.8 years. The Cox proportional hazards model was used to identify independent predictors of HF rehospitalisation and all-cause mortality. Predictors of HF rehospitalisation were LVEF, MR and PVL at the last echocardiographic follow-up. The majority of patients were in NYHA Class I or II and showed mild/trivial paravalvular leak throughout follow-up. Mean pressure gradients remained stable over time. The overall crude cumulative incidences of structural valve deterioration and bioprosthetic valve failure were 3.6% and 2.5%, respectively. CONCLUSIONS: Although overall mortality was high in this elderly patient cohort, the CoreValve bioprosthesis showed good durability at seven-year follow-up.

A narrative overview: Have clinical trials of PCI vs medical therapy addressed the right question?

BACKGROUND: In RCTs about revascularization, the terms "coronary artery disease" and "ischemic heart disease" are sometimes used interchangeably. This can create confusion concerning inclusion and exclusion criteria, which may lead to uncertain results. OBJECTIVE: Our purpose is to investigate whether the study populations in randomized controlled trials (RCTs) which compared percutaneous coronary revascularization to medical therapy for stable ischemic heart disease specifically enrolled patients with demonstrable ischemia, and how many patients were included in trials with evidence of coronary atherosclerosis but without evidence of ischemia. METHODS: Trial published data were obtained from ACME I, ACME II, RITA I, RITA II, MASS I, MASS II, AVERT, ACIP, COURAGE and FAME2. Published data were used to calculate the number of patients included in the trials with a negative stress test but significant coronary artery stenosis and the number of patients excluded from the trials with a positive stress test or angina, but without significant coronary artery stenosis at the time of angiography. RESULTS: A total of 196,433 patients were screened between 1998 and 2011. Overall about 30% of patients were excluded if they did not meet the angiographic criteria, even though the presence of inducible ischemia or angina, and, about 20% of patients were included without inducible ischemia. CONCLUSION: RCTs have contributed to the confusion between coronary artery disease and ischemic heart disease. This may limit the ability to interpret the results and apply them in practice.

Hypotestosteronemia is frequent in ST-elevation myocardial infarction patients and is associated with coronary microvascular obstruction.

BACKGROUND: Gonadal function is thought to be involved in existing atherosclerotic plaques stabilization and might affect reperfusion after primary percutaneous coronary intervention (pPCI). We aimed to compare the prevalence of hypotestosteromenia between ST-elevation myocardial infarction (STEMI) and stable angina (SA) patients and between patients with and without microvascular obstruction (MVO). DESIGN: Cross-sectional observational study. METHODS: Males with STEMI (n = 70, age 57.1 ± 7.8 years) or with stable angina (n=30, age 59.9 ± 8.4 years) were enrolled. Angiographic MVO (angio-MVO) was defined as final TIMI flow 2 or final TIMI flow 3 with MBG ≤ 2 while electrocardiographic MVO (ECG-MVO) as a ST-segment resolution <70% at 90 minutes post-pPCI. Variables associated with STEMI and MVO were assessed among clinical, angiographic and laboratory data including testosterone (T) and insulin-like factor 3 (INSL-3), a marker of Leydig cells function. Hypotestosteronemia was defined as T<2.50 ng/ml with INSL-3<305.5 pg/ml. RESULTS: Hypotestosteronemia was detected in 32 (45.7%) STEMI patients and in 4 (13.3%) SA patients (p=0.003). STEMI patients presenting with angio-MVO were more frequently hypotestosteronemic as compared with those without (60.9% vs 38.3%, p=0.043). Hypotestosteronemia prevalence was higher among STEMI patients presenting with ECG-MVO as compared with those without (69.0% vs 31.7%, p=0.003). At multivariate analysis hypotestosteronemia independently predicted both angio-MVO (OR=4.47, 95% CI 1.30-15.36, p=0.018) and ECG-MVO (OR=7.56, 95% CI 2.20-25.99, p=0.001). CONCLUSIONS: Our study shows higher prevelence of hypotestosteronemia among STEMI patients as compared with SA patients and among STEMI patients with MVO as compared with those without, thus suggesting a possible role of T deficiency in coronary instability and MVO pathogenesis.

Case-control registry of excimer laser coronary angioplasty versus distal protection devices in patients with acute coronary syndromes due to saphenous vein graft disease.

Laser atherectomy might decrease procedural complications during percutaneous coronary intervention (PCI) of degenerated saphenous vein grafts (SVGs) in case of unstable or thrombotic lesions because of its ability to debulk and vaporize thrombus. We aimed at prospectively evaluating the safety and efficacy of excimer laser coronary angioplasty (ELCA) as a primary treatment strategy in consecutively unstable patients undergoing PCI of degenerated SVG lesions. Seventy-one consecutive patients with non-ST elevation acute coronary syndrome (mean age 69 ± 10 years, 66 men [89%]) undergoing PCI of degenerated SVG were enrolled in a prospective case-control registry, using 2 different distal protection devices (DPDs; FilterWire EZ [Boston Scientific, Natick, Massachusetts; n = 24] and SpiderRX [Ev3, Plymouth, Minnesota; n = 23]) or ELCA (n = 24). Primary end points of the study were incidence of angiographic microvascular obstruction (Thrombolysis In Myocardial Infarction flow grade of <3 or Thrombolysis In Myocardial Infraction flow grade of 3 with myocardial blush grade 1 to 2) and incidence of type IVa myocardial infarction. Angiographic microvascular obstruction incidence tended to be less in ELCA-treated patients compared with DPD-treated patients (3 [13%] vs 15 [32%], p = 0.09). Type IVa myocardial infarction incidence was more in DPD-treated patients compared with ELCA-treated patients (23 [49%] vs 5 [21%], p = 0.04). In conclusion, in patients with non-ST elevation acute coronary syndrome undergoing PCI of degenerated SVG, ELCA compared with DPD, is associated with a trend for better myocardial reperfusion and a lesser incidence of periprocedural necrosis. Controlled randomized trials are warranted to confirm these early observations.