Objectives
Aim of this study is to evaluate safety, feasibility, and mid‐term outcome of transcatheter aortic valve implantation (TAVI) in cardiogenic shock (CS).
Background
Balloon aortic ...valvuloplasty in patients with severe aortic valve stenosis (SAS) complicated by CS is indicated but associated with a grim prognosis. TAVI might be a more reasonable treatment option in this setting but data are scant.
Methods
From March 2008 to February 2019, 51 patients with severe aortic valvulopathy (native SAS or degenerated aortic bioprosthesis) and CS treated by TAVI in 11 European centers were included in this multicenter registry. Demographic, clinical, and procedural data were collected, as well as clinical and echocardiographic follow‐up.
Results
The mean age of our study population was 75.8 ± 13, 49% were women, and mean Society of Thoracic Surgeons (STS) score was 19 ± 15%. Device success was achieved in 94.1%, with a 5% incidence of moderate/severe paravalvular leak. The 30‐day events were mortality 11.8%, stroke 2.0%, vascular complications 5.9%, and acute kidney injury 34%. Valve Academic Research Consortium‐2 early safety endpoint was reached in 35.3% of cases. At 1‐year of follow‐up, the mortality rate was 25.7% and the readmission for congestive heart failure was 8.6%.
Conclusions
TAVI seems to be a therapeutic option for patients with CS and SAS or degenerated aortic bioprosthesis in terms of both safety and efficacy at early and long‐term follow‐up.
Data on the long-term prognosis of percutaneous coronary intervention (PCI) in young patients are limited. The aim of the present study was to report the immediate and long-term clinical outcomes in ...a consecutive series of young patients with premature coronary artery disease who underwent PCI with stent implantation. During the study period (2005 to 2010), 214 consecutive patients aged ≤40 years who had undergone PCI with a bare metal stent or drug-eluting stent implantation were retrospectively selected and analyzed. Primary end point of this study was the incidence of major adverse cardiac and cerebrovascular events at short- and long-term follow-up. Mean age was 36.3 ± 3.5 years and 88.3% of patients were men. Three-quarters were active smokers and all patients had ≥1 conventional cardiovascular risk factor. The total number of implanted stents was 272 (154 bare metal stent and 118 drug-eluting stent). During the hospital stay, no patient died, and the incidence of major adverse cardiac and cerebrovascular events was 2.3%. No additional events had occurred at 30 days of follow-up. At a median follow-up of 757 days (interquartile range 365 to 1,818), the overall death rate was 0.9%, and a new revascularization procedure was needed in 12.6% of patients. The major adverse cardiac and cerebrovascular event-free survival rate at the median follow-up point and 1,818 days was 89.6% and 84.2%, respectively. Active smoking and left ventricular ejection fraction <50% were independent predictors of major adverse cardiac and cerebrovascular events. In conclusion, PCI in young patients lead to excellent results in short- and long-term follow-up and should be considered as the treatment of choice. Traditional risk factors are important prognostic determinants of adverse events and might help identify higher risk patients within this cohort.
Valve‐in‐valve transcatheter valve implantation (ViV‐TAVI) procedures for deteriorated bioprosthesis are an established therapeutic option for high‐risk patients. The presence of the fixed sewing ...ring of the bioprosthesis can hamper appropriate expansion of the TAVI. We present a case of a ViViV‐TAVI, as a salvage procedure for acute ViV‐TAVI failure.
The presence of the fixed sewing ring of the bioprosthesis can hamper appropriate expansion of the TAVI during valve‐in‐valve transcatheter valve implantation (ViV‐TAVI) procedure. The case demonstrates that ViV‐TAVI is feasible as a salvage procedure for acute ViV‐TAVI failure.
The aim of this study was to investigate the safety and efficacy of coronary protection by preventive coronary wiring and stenting across the coronary ostia in patients at high risk for coronary ...obstruction after transcatheter aortic valve replacement (TAVR).
Coronary obstruction following TAVR is a life-threatening complication with high procedural and short-term mortality.
Data were collected retrospectively from a multicenter international registry between April 2011 and February 2019.
Among 236 patients undergoing coronary protection with preventive coronary wiring, 143 had eventually stents implanted across the coronary ostia after valve deployment. At 3-year follow-up, rates of cardiac death were 7.8% in patients receiving stents and 15.7% in those not receiving stents (adjusted hazard ratio: 0.42; 95% confidence interval: 0.14 to 1.28; p = 0.13). There were 2 definite stent thromboses (0.9%) in patients receiving stents, both occurring after TAVR in “valve-in-valve” procedures. In patients not receiving stents, there were 4 delayed coronary occlusions (DCOs) (4.3%), occurring from 5 min to 6 h after wire removal. Three cases occurred in valve-in-valve procedures and 1 in a native aortic valve procedure. Distance between the virtual transcatheter valve and the protected coronary ostia <4 mm was present in 75.0% of patients with DCO compared with 30.4% of patients without DCO (p = 0.19).
In patients undergoing TAVR at high risk for coronary obstruction, preventive stent implantation across the coronary ostia is associated with good mid-term survival rates and low rates of stent thrombosis. Patients undergoing coronary protection with wire only have a considerable risk for DCO.
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Dual antiplatelet therapy (DAPT) with aspirin and a P2Y12 receptor antagonist is the cornerstone of therapy in patients with acute coronary syndrome (ACS). Adherence to medical therapy is an ...important issue, as premature DAPT discontinuation increases the risk of new ischemic events. The aim of the present observational prospective multicenter study was to evaluate in the real-world incidence and discontinuation patterns of ticagrelor during the first 12 months after ACS.
We analyzed 431 ACS patients, discharged with ticagrelor, by 7 Italian centers. The primary end-point was the incidence of cessation of ticagrelor up to 12 months from the index event.
Definitive ticagrelor cessations occurred in 52 patients (12.1%), of which 35 were discontinuations (clinically driven) and 17 disruptions (due to acute events). Temporary cessation occurred in 14 cases (3.3%). Age ≥ 80 years and anticoagulant therapy were independent predictors of premature discontinuation. Bleeding occurred in 74 patients, of which 25 suffered a BARC ≥ 2 bleeding event. Bleeding were more frequent in female sex (27.0% vs 17.2%, p-value 0.049) and in patients with a history of bleeding (8.1% vs 2.9%, p-value 0.035).
Our study found that the adherence to DAPT with ticagrelor after an ACS is still an important issue, premature discontinuation occurred mainly in fragile patients, like elderly, who suffered a previous bleeding or underwent previous percutaneous coronary intervention.
To compare coronary artery bypass grafting (CABG) with percutaneous transluminal coronary angioplasty (PTCA) in patients with proximal, isolated de novo left anterior descending coronary artery ...disease and left ventricular ejection fraction of 45%.
In the multicenter Stenting vs Internal Mammary Artery (SIMA) study, patients were randomly assigned to PTCA and stent implantation or to CABG (using the internal mammary artery). The primary clinical composite end point was event-free survival, including death, myocardial infarction, and the need for additional revascularization. Secondary end points were functional class, antianginal treatment, and quality of life. Analyses were by intention to treat.
Of 123 patients who accepted randomization, 59 underwent CABG, and 62 were treated with stent implantation (2 patients were excluded because of protocol violation). At a mean ± SD follow-up of 2.4±o.9 years, a primary end point had occurred in 19 patients (31%) in the stent group and in 4 (7%) in the CABG group (P<.OOI). This significant difference in clinical outcome is due to a higher incidence of additional revascularization in the stent group, the incidence of death and myocardial infarction being similar (7% vs 7%, respectively;
P=.90). The functional class, need for antianginal drug, and quality-of-life assessment showed no significant differences.
Both stent implantation and CABG are safe and highly effective treatments to relieve symptoms in patients with isolated, proximal left anterior descending coronary artery stenosis. Both are associated with a low and comparable incidence of death and myocardial infarction. However, similar to PTCA alone, a percutaneous approach using elective stent placement remains hampered by a higher need for repeated intervention because of restenosis.
Abstract Objectives This study sought to assess in vivo sex differences in the pathophysiology of ST-segment elevation myocardial infarction (STEMI) and vascular response to primary percutaneous ...coronary intervention (PCI). Background There is no consensus on whether differences in the pathophysiology of STEMI and response to primary PCI between women and men reflect biological factors as opposed to differences in age. Methods In this prospective, multicenter study, 140 age-matched men and women with STEMI undergoing primary PCI with everolimus-eluting stent were investigated with intravascular optical coherence tomography, histopathology-immunohistochemistry of thrombus aspirates, and serum biomarkers. Primary endpoints were the percentages of culprit plaque rupture at baseline and everolimus-eluting stent strut coverage at 9-month follow-up as determined by optical coherence tomography. Results Men and women had similar rates of plaque rupture (50.0% vs. 48.4%; risk ratio RR: 1.03; 95% confidence interval CI: 0.73 to 1.47; p = 0.56). Nonruptured/eroded plaques comprised 25% of all cases (p = 0.86 in men vs. women). There were no sex differences in composition of aspirated thrombus and immune and inflammatory serum biomarkers. At 9 months, women had similar strut coverage (90.9% vs. 92.5%; difference in medians: RR: 0.2%; 95% CI: –0.4% to 1.3%; p = 0.89) and amount of in-stent neointimal obstruction (10.3% vs. 10.6%; p = 0.76) as men did. There were no sex differences in clinical outcome either at 30-day or 1-year follow-up. Conclusions In patients presenting with STEMI undergoing primary PCI, no differences in culprit plaque morphology and factors associated with coronary thrombosis were observed between age-matched men and women. Women also showed similar vascular healing response to everolimus-eluting stents as men did. (Optical Coherence Tomography Assessment of Gender Diversity In Primary Angioplasty: The OCTAVIA Trial OCTAVIA; NCT01377207 )
The respective roles of oral anticoagulation or antiplatelet therapy following transcatheter aortic valve implantation (TAVI) remain debated. ATLANTIS is an international, randomized, open-label, ...superiority trial comparing apixaban to the standard of care.
After successful TAVI, 1500 patients were randomized (1:1) to receive apixaban 5 mg (2.5 mg if impaired renal function or concomitant antiplatelet therapy) (n = 749) twice daily, or standard of care (n = 751). Randomization was stratified by the need for chronic anticoagulation therapy. Standard-of-care patients received a vitamin K antagonist (VKA) (Stratum 1) or antiplatelet therapy (Stratum 2) if there was an indication for anticoagulation or not, respectively. The primary endpoint was the composite of death, myocardial infarction, stroke or transient ischaemic attack, systemic embolism, intracardiac or bioprosthesis thrombosis, deep vein thrombosis or pulmonary embolism, and life-threatening, disabling, or major bleeding over 1-year follow-up. The primary safety endpoint was major, disabling, or life-threatening bleeding. The primary outcome occurred in 138 (18.4%) and 151 (20.1%) patients receiving apixaban or standard of care, respectively hazard ratio (HR) 0.92; 95% confidence interval (CI) 0.73-1.16 and there was no evidence of interaction between treatment and stratum (Pinteraction = 0.57). The primary safety endpoint was similar in both groups (HR 1.02; 95% CI 0.72-1.44). In Stratum 1 (n = 451), an exploratory analysis showed no difference for all endpoints between apixaban and VKA. In Stratum 2 (n = 1049), the primary outcome and primary safety endpoint did not differ, but obstructive valve thrombosis was reduced with apixaban vs. antiplatelet therapy (HR 0.19; 95% CI 0.08-0.46), while a signal of higher non-cardiovascular mortality was observed with apixaban.
After TAVI, apixaban was not superior to the standard of care, irrespective of an indication for oral anticoagulation.
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