Procedural Reassessment of Radiofrequency Renal Denervation in Resistant Hypertensive Patients.

INTRODUCTION: Recent anatomical and clinical studies have led to the hypothesis that in several cases of failure of response to renal denervation (RDN), the procedure has not been technically correct. AIM: To perform procedural reassessment in patients with true resistant hypertension who underwent RDN. METHODS: We retrospectively reassessed the procedural technique of RDN in 10 true resistant hypertensive patients, comparing the sites of renal ablations with the knowledge of animal and human post mortem evidences. Procedural ablation technique was assessed in terms of number of ablations for each renal artery and site of ablation (quadrant and distance from renal ostium) by using the radiologic images of each RDN and the number of radiofrequency ablation attempts documented in the reports of each denervation session. RESULTS: 10 patients were studied, 9 denervated with Simplicity monoelectrode catheter, 1 with multielectrode balloon technique. Responders to the procedure underwent more ablations and particularly at least a quadrant ablation in one of the kidney arteries, >2 ablations in Dorsal plus Ventral quadrants and in 67% of then >10 ablations were done in superior inferior and ventral quadrants. CONCLUSION: This study confirms the importance of a well knowledge of renal artery anatomy and underlines the relevance of the choice of ablation sites in order to obtain a successful RDN procedure.

[Transcatheter valve-in-valve implantation in a patient with a degenerative sutureless aortic bioprosthesis: case report and literature review]. / Impianto transcatetere di valvola aortica in paziente con bioprotesi aortica sutureless degenerata: descrizione di un caso e revisione della letteratura.

Sutureless aortic bioprostheses (SAB) provide shorter aortic cross-clamp time and cardiopulmonary bypass duration compared to conventional aortic valve replacement. Similarly to other bioprostheses, reintervention may become necessary in some cases because of long-term structural degeneration of the valve. Valve-in-valve (ViV) transcatheter aortic valve replacement may represent an effective and safe alternative to aortic valve replacement in patients with degenerated bioprostheses who carry a high risk for reintervention. We report the case of a self-expandable transcatheter ViV procedure in a degenerated SAB.

Relationship between early administration of abciximab and TIMI flow in STEMI patients undergoing primary angioplasty: findings from a large regional STEMI network.

AIMS: The aim of this study is to assess whether in S-T Elevation Myocardial Infarction (STEMI) a relationship between early administration of abciximab and Thrombolysis In Myocardial Infarction (TIMI) flow before and after primary percutaneous coronary intervention (PCI) in 960 consecutive patients exists. METHODS: From 1 February 2001 onward, in the Province of Mantua it has been operating a 'Cardiology Network for the Acute Infarction Care' having its Hub in the Central Coronary ICU/Cath Lab of Mantua Hospital and being its Spokes centers represented by the emergency rooms and Central Coronary ICUs of the four territorial hospitals. RESULTS: T1 (time from symptoms onset to first medical contact) and T2 (time from first medical contact to angioplasty) are shorter for patients rescued by first aid units rather than for those presented in emergency rooms as well as Ta (time from symptoms onset to abciximab administration). Furthermore, the patients that received abciximab before hospital arrival had less frequently a coronary occlusion [odds ratio = 0.74, 95% confidence interval (0.57-0.96), P = 0.013]. The patients with T1 less than 4 h are 753/960 (78.4%). For this type of patients, there was a significant Ta difference between the pre-PCI TIMI-flow classes (F = 4.467, df = 3, P = 0.04). Planned contrasts revealed that mean time of TIMI flow 0 (M = 104.2) is statistically different from mean time of TIMI flow 3 (M = 85.7), P = 0.013. CONCLUSION: Our results suggest that the use of abciximab, free from pharmacokinetic limits of oral P2Y12 inhibitors, should be considered in STEMI patients with early presentation before primary PCI.

[A novel standard protocol of long-term follow-up shared with general practitioners after percutaneous coronary intervention: appropriateness and economic impact]. / Il follow-up del paziente sottoposto a rivascolarizzazione coronarica percutanea: impatto potenziale dell'applicazione di un percorso clinico-gestionale strutturato sull'integrazione ospedale-territorio e modulato sul rischio clinico del paziente.

BACKGROUND: Follow-up modalities for patients undergoing percutaneous coronary intervention (PCI) are not well defined and standard protocols have been not established. The purpose of this study was to assess: a) the frequency and patterns of cardiology visits, echocardiographic examinations and stress tests after PCI in clinical practice; b) the impact of a multidisciplinary protocol of long-term follow-up after PCI shared with general practitioners on the appropriateness and reduction in healthcare costs. METHODS: A total of 780 patients who underwent PCI in 2010 in two Italian hospitals were analyzed. The number of cardiological examinations (total, routine and clinically driven) performed during 2 years of follow-up were recorded and stratified according to the patient's risk profile. The latter was defined according to the multidisciplinary protocol. In addition, a simulation of the spread between provided and necessary tests (according to the multidisciplinary protocol) was carried out. RESULTS: The mean number of cardiological examinations per patient provided during follow-up was 5, of which 4.4 were routine tests in asymptomatic patients. Routine tests were performed more frequently in patients at low risk compared to those at higher risk. By applying the multidisciplinary protocol to the case mix and by merging clinical visit and stress test or echocardiographic examination, a reduction of 0.87 tests per patient/year would be expected. This reduction would result in a 39% decrease in follow-up examinations in this specific clinical setting. CONCLUSIONS: This observational study demonstrates that unnecessary cardiological clinical and functional tests are often performed in long-term follow-up of patients submitted to PCI. The application of a standard protocol of follow-up shared with general practitioners may help avoiding unnecessary consultations, thus reducing healthcare costs.

A clinical and angiographic study of the XIENCE V everolimus-eluting coronary stent system in the treatment of patients with multivessel coronary artery disease: the EXECUTIVE trial (EXecutive RCT: evaluating XIENCE V in a multi vessel disease).

OBJECTIVES: This study sought to investigate the efficacy and performance of the XIENCE V everolimus-eluting stent (EES) (Abbott Vascular, Santa Clara, California) in the treatment of de novo coronary lesions in patients with 2- to 3-vessel multivessel coronary artery disease (MV-CAD). BACKGROUND: Drug-eluting stents (DES) have emerged as an alternative to conventional coronary artery bypass surgery in patients with MV-CAD although first-generation DES yielded inferior efficacy and safety compared with surgery. METHODS: Prospective, randomized (1:1), multicenter feasibility trial was designed to assess angiographic efficacy of EES compared with the TAXUS paclitaxel-eluting stent (PES) in 200 patients, and a prospective, open-label, single-arm, controlled registry was designed to analyze the clinical outcome of EES at 1-year follow-up in 400 MV-CAD patients. For the randomized trial, the primary endpoint was in-stent late loss at 9 months. For the registry, the primary endpoint was a composite of all-cause death, myocardial infarction, and ischemia-driven target vessel revascularization at 12 months. RESULTS: The primary endpoint per single lesion was significantly lower in the EES group compared with the PES group (-0.03 ± 0.49 mm vs. 0.23 ± 0.51 mm, p = 0.001). Similar results were observed when analyzing all lesions (0.05 ± 0.51 mm vs. 0.24 ± 0.50 mm, p < 0.001). Clinical outcome at 1 year yielded a composite of major adverse cardiac events of 9.2% in the single-arm registry, and 11.1% and 16.5% in the EES and PES randomized groups, respectively (p = 0.30). CONCLUSIONS: The EXECUTIVE trial was a randomized pilot trial dedicated to the comparison of the efficacy of 2 different DES among patients with 2- to 3-vessel MV-CAD. The study shows lower in-stent late loss at 9 months with the EES XIENCE V compared with the PES TAXUS Libertè, and a low major adverse cardiac event rate at 1 year in patients with 2-to 3-vessel MV-CAD. (EXECUTIVE [EXecutive RCT: Evaluating XIENCE V in a Multi Vessel Disease]; NCT00531011).

Prognostic implications of early and long-term bleeding events in patients on one-year dual antiplatelet therapy following drug-eluting stent implantation.

BACKGROUND: Bleeding has emerged as a predictor of early and late mortality after percutaneous coronary interventions. However, the prevalence and predictors of long-term bleeding events in patients on prolonged dual antiplatelet therapy (DAPT) after drug-eluting stent (DES) implantation has been poorly explored. METHODS: A total of 1,437 patients undergoing DES implantation discharged on DAPT with aspirin and clopidogrel for 1 year were studied. Patients were followed for up to 4 years (34.3 ± 14.4 months) and the prevalence and predictors of in-hospital and long-term thrombolysis in myocardial infarction (TIMI) major and minor bleeding events evaluated. The impact of bleeding events on major adverse cardiac events (MACE), overall death, and stent thrombosis (ST) was also assessed. RESULTS: The incidences of 30 days major and minor bleeding were 1.3 and 3.3%, respectively. The incidences of 1-year major and minor bleeding were 3.0 and 5.6%, respectively. The incidences of major and minor bleeding up to 4-year follow-up were 3.6 and 6.9%, respectively. At multivariable analysis, 1-year major bleeding was positively predicted by use of oral anticoagulants at hospital discharge [odds ratio (OR) = 13.4, 95% confidence interval (CI) 3.0-59.2, P = 0.001], anemia at admission (OR = 6.7, 95% CI = 2.7-16.5, P < 0.001) and use of glycoprotein IIb/IIIa inhibitors (OR = 2.7, 95% CI = 1.1-6.5, P = 0.03) and negatively predicted by male gender (OR = 0.39, 95% CI = 0.16-0.97, P = 0.042). Overall, major bleeding at 1 year and at long-term follow-up was associated with an increased risk of MACE, cardiac death and ST. Patients who had any bleeding event were more likely to prematurely discontinue antiplatelet therapy (50% vs. 9.6%, P < 0.001). CONCLUSIONS: In DES-treated patients on prolonged DAPT, major bleeding occurring at 1 year and up to 4 years following DES implantation in patients on prolonged DAPT is associated with poor long-term prognosis.

Safety of clopidogrel and proton pump inhibitors in patients undergoing drug-eluting stent implantation.

OBJECTIVE: A pharmacodynamic interaction between clopidogrel and proton pump inhibitors (PPIs) has been suggested, leading to reduced clopidogrel-induced platelet inhibitory effects. However, data from clinical studies are conflicting. The aim of this study was to evaluate the safety of long-term clopidogrel and PPI therapy. METHODS: A total of 1328 consecutive patients (age 63±11 years; 81% male) undergoing drug-eluting stent implantation and 1-year follow-up were included. All patients were treated with a standard aspirin and clopidogrel treatment regimen for 12 months. The concomitant PPI therapy for the same duration was at the discretion of the clinical cardiologist. PPI therapy included lansoprazole (30 mg/day), pantoprazole (20 mg/day), or omeprazole (20 mg/day). At 1-year follow-up, major adverse cardiac events (MACE), defined as death, myocardial infarction (MI), acute coronary syndrome leading to hospitalization and nonfatal stroke, were recorded. All cause death, any stent thrombosis (ST), and bleeding (Thrombolysis in MI major and minor) were also assessed. RESULTS: Lansoprazole, pantoprazole, and omeprazole were administered to 855, 178, and 125 patients, whereas 170 were not prescribed any PPI therapy. Among patients treated with PPIs, those on pantoprazole had more often prior MI, multivessel coronary artery disease, and chronic kidney disease, whereas earlier peptic ulcer was more frequent among patients treated with omeprazole. The incidence of 1-year MACE was not statistically different between patients in the PPI and no-PPI groups (7.5 vs. 5.0%; P=0.26). Similarly, 1-year rates of all cause death, ST, and Thrombolysis in MI major and minor bleedings did not significantly differ. After statistical adjustment for potential confounders, the concomitant use of clopidogrel and PPIs was not associated with the risk of 1-year MACE [odds ratio (OR) 1.54, P=0.38], death (OR: 0.97, P=0.961), and ST (OR: 1.01, P=0.998). No differences across the three PPI types were found. CONCLUSION: The association of clopidogrel and PPIs after drug-eluting stent implantation, prescribed on clinical judgement, seems safe.

[Percutaneous coronary revascularization in patients over eighty: acute and long-term results]. / Rivascolarizzazione coronarica percutanea nei pazienti ultraottantenni: risultati immediati e a lungo termine.

BACKGROUND: As a consequence of prolonged life expectancy the number of older patients with symptomatic coronary artery disease is constantly increasing. The aim of the study was to evaluate procedural success, immediate and long-term outcomes and the predictive factors of prognosis in patients aged > 80 years with high-risk coronary artery disease treated with coronary angioplasty. METHODS: In this retrospective study, we report the diagnostic and therapeutic strategies adopted in patients aged > 80 years admitted to our institution for acute coronary syndrome with or without ST-segment elevation or disabling angina (CCS class 3-4) and the immediate and long-term results of patients treated with coronary angioplasty. RESULTS: A conservative approach was adopted in 180 patients (33%, group 1) out of the total number of 545 patients, while 365 patients (67%, group 2) underwent coronary angiography. Among these, 85% underwent revascularization. Relevant comorbidities were significantly higher in group 1 (59 vs 16%, p < 0.001) while a clinical presentation with ST-elevation myocardial infarction was prevalent in group 2 (15 vs 6%, p = 0.007). The in-hospital mortality was 19% in group 1 and 7.9% in group 2 (p = 0.001). Among 198 patients treated with angioplasty, procedural success was achieved in 93% of cases, with 8% in-hospital mortality. Periprocedural myocardial infarction occurred in 3.3% and major bleeding in 5.6% of patients. At multivariate analysis ST-elevation myocardial infarction and cardiogenic shock were significantly related to the in-hospital mortality. At follow-up (mean 25 +/- 13 months) 13 patients died, 9 from cardiac causes and 4 from noncardiac events. Recurrence of ischemia requiring revascularization occurred in 15.9% of cases. Cumulative survival at follow-up was respectively 86% at 1 year and 83% at 5 years, while the event-free survival at 5 years was 59% in the entire group, without any significant difference among patients with multivessel disease in whom a complete vs an incomplete revascularization was performed. The presence of severe comorbidities appeared to be the only predictive factor of unfavorable outcome at long-term follow-up at multivariate analysis. CONCLUSIONS: In patients aged > 80 years with symptomatic ischemic heart disease at high risk, the invasive approach was prevalent. Higher mortality rates were found in patients in whom coronary angiography was not performed. Comorbidities represent an important negative prognostic factor, impairing both the possibility of an invasive approach and conditioning an unfavorable outcome of revascularized patients. Coronary angioplasty can be successfully performed even in elderly patients. The in-hospital mortality turns out significantly higher in the setting of an acute ST-elevation myocardial infarction or in cardiogenic shock patients. For patients overcoming the acute phase, high survival rates can be expected at follow-up.

[The use of the Export Catheter device in a patient with acute myocardial infarction for thrombotic occlusion of the venous graft on the left anterior descending coronary artery: a case report]. / Utilizzo di Export Catheter in paziente con infarto miocardico acuto per occlusione trombotica del graft venoso su discendente anteriore: descrizione di un caso clinico.

Coronary angioplasty, eventually followed by stent implantation, represents the gold standard of acute myocardial infarction (AMI) treatment. Optimal reperfusion implies both patency of the infarct-related artery and a good myocardial microrevascularization with normal tissue reperfusion. The so called no-reflow phenomenon mainly occurs in the presence of highly thrombotic lesions, especially during primary angioplasty and it represents a negative prognostic factor of the outcome of AMI patients treated with angioplasty. A 77-year-old high-risk male patient, previous coronary artery bypass graft with the saphenous vein graft to the left anterior descending coronary artery for post-AMI angina in 1984, aided by 118 ambulance for anterior AMI was admitted to our cath-lab for primary coronary angioplasty. During the transport he was given aspirin i.v. 300 mg, heparin 5000 IU and abciximab (9.4 ml bolus plus infusion for 12 hours). The time of treatment (from symptom onset to first inflation) was about 90 min. Coronary angiography showed a massive thrombus occlusion of the vein graft with TIMI 0 distal flow. We employed the Export Catheter for mechanical aspiration of the occluding thrombus. The procedure was completed with direct stent implantation with good angiographic outcome. The use of thrombus aspiration and protection devices (filters or occlusive balloons) associated or not with the use of glycoprotein IIb/IIIa receptor blockers, has reduced the risk of distal embolization and of no-reflow phenomenon.