[Epidemiology of stroke and cerebral protection in patients undergoing transcatheter aortic valve replacement]. / Epidemiologia e prevenzione dell'ictus in pazienti sottoposti ad impianto transcatetere di valvola aortica.

The introduction into clinical practice of transcatheter aortic valve implantation (TAVI) has led to a significant change in the therapeutic paradigm for patients with valvular aortic stenosis. However, in parallel with the benefits obtained in prognosis and quality of life, an inherent risk of major cerebral thromboembolic events has been observed. In different studies this risk has been estimated between 2% and 6%. In order to reduce the incidence of cerebrovascular accidents during TAVI, several brain protection systems have been developed but, to date, none has obtained sufficient clinical evidence to be implemented on a large scale, and they are therefore used only in selected cases. Furthermore, periprocedural drug therapy and follow-up are still the subject of extensive discussion in the scientific community. This paper reviews the topic of stroke prevention in patients undergoing TAVI for both the periprocedural and postprocedural aspects.

Interplay between mitral regurgitation and transcatheter aortic valve replacement with the CoreValve Revalving System: a multicenter registry.

BACKGROUND: Little is known of the prognostic significance of mitral regurgitation (MR) on transcatheter aortic valve replacement (TAVR), the impact of TAVR on MR severity, and the variables associated with possible post-TAVR improvement in MR. We evaluated these issues in a multicenter registry of patients undergoing CoreValve Revalving System-TAVR. METHODS AND RESULTS: Among 1007 consecutive patients, 670 (66.5%), 243 (24.1%), and 94 (9.3%) presented with no/mild, moderate, and severe MR, respectively. At 1 month after TAVR, patients with severe or moderate MR showed comparable mortality rates (odds ratio, 1.1; 95% confidence interval [95% CI], 0.7-1.55; P=0.2), but both were significantly higher compared with patients with mild/no MR (odds ratio, 2.2; 95% CI, 1.78-3.28; P<0.001; and odds ratio, 1.9; 95% CI, 1.1-3.3; P=0.02, respectively). One-year mortality was also similar between patients with severe and those with moderate MR (hazard ratio, 1.4; 95% CI, 0.94-2.4; P=0.06) and still significantly higher compared with patients with mild/no MR (hazard ratio, 1.7; 95% CI, 1.2-3.41; P<0.001; and hazard ratio, 1.4; 95% CI, 1.2-2.2; P=0.03, respectively). Severe pulmonary hypertension, atrial fibrillation, and MR more than mild, but not an improvement of ≥1 grade in MR severity, were independent predictors of mortality at 1 year. At 1 year, an improved MR was observed in 47% and 35% of patients with severe and moderate MR, respectively. The rate of low implantation was consistent across groups with improved, unchanged, or worsened MR. A functional type of MR and the absence of severe pulmonary hypertension and atrial fibrillation independently predicted the improvement in MR severity. CONCLUSIONS: Baseline MR greater than mild is associated with higher mortality after CoreValve Revalving System-TAVR. A significant improvement in MR was more likely in patients with functional MR and without severe pulmonary hypertension or atrial fibrillation. The improvement in MR did not independently predict mortality.

Selection of Medications to Prevent Stroke Among Individuals With Atrial Fibrillation : Update on Prevention of Stroke in Patients with AF.

OPINION STATEMENT: Vitamin K antagonists have been the only available orally active anticoagulants for decades. Although effective, their numerous limitations have driven the introduction of new oral anticoagulants (NOAs) that showed effectiveness at fixed doses without the need for routine coagulation monitoring. However, the safety and efficacy observed in controlled clinical trials may be hard to translate in clinical practice. Clinical conditions as well as drug interactions may considerably impact on patient outcomes. Moreover, the inability to monitor the pharmacological activity of NOAs and the absence of any antidote in the setting of bleeding or emergent invasive procedures may limit their use. Vitamin K antagonists will be still used in many circumstances, including patients with an optimal control of the INR, with mechanical heart valves, and other indications for which these new agents have not been investigated. Nevertheless, these new agents will reduce the burden of anticoagulation management at the patient as well as Health Care level.

Right subclavian approach as a feasible alternative for transcatheter aortic valve implantation with the CoreValve ReValving System.

AIMS: Arterial access selection is crucial during transcatheter aortic valve implantation. When traditional femoral access has been deemed unfeasible the left subclavian artery has been used successfully. In cases where even the latter was ineligible, we opted, despite the lack of any data, for the right subclavian approach. We hereby present the results of the first series available. Our aim was to evaluate the feasibility and performance of the CoreValve ReValving System (CRS) implantation via the right subclavian artery in patients with contraindication to femoral and left subclavian accesses. METHODS AND RESULTS: Among 300 patients who have undergone CRS implantation, 70 (23%) have been treated via the subclavian approach, 10 via the right subclavian artery and 60 via the left. Demographic features were quite similar except for the presence of significant left subclavian disease in all patients treated via the right subclavian artery. The success rate was 100% for both groups. At 30-day follow-up, there was no significant difference in terms of all-cause mortality and cardiac mortality between right vs. left subclavian approach (0% vs. 6.6% and 0% vs. 6.6%, respectively). Consistent results were observed at a mean follow-up of 12±7.9 months (all-cause mortality: 10% vs. 15%). Incidences of new AV block requiring PM implantation were also statistically equivalent. CONCLUSIONS: CRS implantation via the right subclavian artery was as feasible and safe as the left subclavian approach. It poses very particular technical issues but should be considered when more conventional approaches are inadequate in order to provide patients with a further chance to be treated effectively.

Transcatheter valve-in-valve implantation using Corevalve Revalving System for failed surgical aortic bioprostheses.

OBJECTIVES: The purpose of this study was to evaluate the performance of CoreValve Revalving System (CRS) (Medtronic, Minneapolis, Minnesota) implantation in patients with failed aortic bioprostheses. BACKGROUND: Transcatheter aortic valve implantation with the CRS is an effective option in high-risk patients with severe aortic stenosis. It may be an option for patients with a failed aortic bioprosthesis, especially when the risk of a surgical redo is deemed prohibitive. METHODS: CRS "valve-in-valve" implantation was performed in 25 high-risk patients with a failed bioprosthesis. Their mean age was 82.4 ± 3.2 years. New York Heart Association functional classes III and IV were present in 21 and 4 patients, respectively. The logistic EuroSCORE was 31.5 ± 14.8%, whereas the Society of Thoracic Surgeons score was 8.2 ± 4.2. Patients/prostheses were divided in type A (mainly stenotic, n = 9) and type B (mainly regurgitant, n = 16). RESULTS: The implantation success rate was 100%. In group A, the peak aortic gradient significantly decreased from 77.6 ± 21.6 mm Hg to 34.6 ± 19.4 mm Hg (p = 0.001). In all but 2 patients in group B, no significant regurgitation was observed post-implantation. No patients died during the procedure. At 30 days, there were 3 deaths (12%), 2 myocardial infarctions (8%), and 3 atrioventricular blocks requiring pacemaker implantation (12%). At a mean follow-up of 6 months, there were another death (survival rate of 84%) and a pacemaker implantation (cumulative incidence of 16%). New York Heart Association functional class improved in all patients to I and II. CONCLUSIONS: CRS implantation was feasible and effective regardless of the prevalent mode of failure. This finding may significantly affect the treatment of patients with a failed bioprosthesis deemed at a prohibitive risk for surgical redo.

Drug eluting stents versus bare metal stents in the treatment of saphenous vein graft disease: a systematic review and meta-analysis.

AIMS: Treatment of saphenous vein graft (SVG) disease is still a matter of debate given the uncertainty of the available conflicting data. Our aim was to assess, by means of a meta-analytic approach, the risk/benefit profile of drug eluting stents (DES) versus bare metal stents (BMS) in the treatment of SVG disease. METHODS AND RESULTS: A search of relevant studies in several databases was performed. The endpoints of interest such as: major adverse events (MAE) (the combination of overall death and non-fatal myocardial infarction [AMI]), target vessel revascularisation (TVR), and target lesion revascularisation (TLR) have been calculated in-hospital and at the longest follow-up. Single endpoints and the rate of stent thrombosis (ST) were also assessed. Three randomised controlled trials and 15 registry studies were appraised, totalling 3,294 patients. During hospitalisation, there was no difference in the risk of MAE, overall death, AMI and TVR. No data were available to calculate the TLR rate. At a mean follow-up of 19.8 months, no significant differences were found in the risk of MAE and AMI. BMS were associated with a trend towards a higher risk of overall death (OR 1.32 [1,00-1.74], p=0.05, number needed to treat [NNT]=55). DES showed superiority in terms of TVR (OR 1.86 [1.33-2.61], p=0.0003, NNT=16), and TLR (OR 1.77 [1.27-2.48], p<0.0001, NNT=25). According to pre-specified subgroup analyses, these effects seem less evident at the long-term follow-up. DES were not associated with an increased risk of ST. CONCLUSIONS: Use of DES in SVG substantially reduces both TVR and TLR. These data also demonstrate that using DES in SVG is safe and contradict previous reports of potential risks.

Antihypertensive effect of barnidipine 10 mg or amlodipine 5 to 10 mg once daily in treatment-naive patients with essential hypertension: A 24-week, randomized, open-label, pilot study.

BACKGROUND: Dihydropyridine calcium antagonists are largely employed for the treatment of hypertension, coronary heart disease, and heart failure. OBJECTIVE: The aim of our study was to compare the antihypertensive effect of the dihydropyridine calcium antagonists barnidipine and amlodipine. METHODS: This was a 24-week, randomized, open-label, pilot study. Consecutive treatment-naive patients with grade I or II essential hypertension (office sitting systolic blood pressure [BP] of 140-179 mm Hg and diastolic BP of 90-109 mm Hg) were enrolled. The primary end points were the effect of treatment with either barnidipine 10 mg or amlodipine 5 mg once daily on office and ambulatory BP, left ventricular mass index (LVMI), and markers of cardiac damage, serum procollagen type I C-terminal propeptide, and plasma amino-terminal pro-B-type natriuretic peptide concentrations. Patients were assessed at enrollment, and 12 and 24 weeks. During each visit, the prevalence of adverse events (AEs) was also monitored using spontaneous reporting, patient interview, and physical examination, the relationship to study drug being determined by the investigators. Compliance with treatment was assessed at each study visit by counting returned tablets. RESULTS: Thirty eligible patients (20 men, 10 women; mean [SD] age, 47 [12] years) were included in the study; all patients completed the 24 weeks of study treatment. Twelve weeks after randomization, 6 patients in the amlodipine group had their dose doubled to 10 mg due to inadequate BP control. Mean BP reductions at study end were not significantly different between the barnidipine and amlodipine groups (office BP, -10.3/-9.4 vs -16.6/-9.1 mm Hg; ambulatory BP, 9.4/6.4 vs 8.1/5.1 mm Hg). Reductions in LVMI and markers of cardiac damage were not significantly different between the 2 groups. Significantly more patients in the amlodipine group reported drug-related AEs compared with those in the barnidipine group (9 [60%] vs 2 [13%]; P < 0.05). CONCLUSION: In this small sample of treatment-naive hypertensive patients, the antihypertensive effect of barnidipine 10 mg once daily was not significantly different from that of amlodipine 5 to 10 mg once daily.