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Although TAVI has proven to be safe and effective for the treatment of aortic stenosis in high-risk patients, Balloon Aortic Valvuloplasty (BAV) has not completely disappeared. On the contrary, it's sometimes indicated as a “bridge” to TAVI, that may eventually be performed after clinical

Background Pulmonary hypertension (PH) is often found in cystic fibrosis (CF) patients affected by end-stage lung disease but its impact on outcome remains unclear. Pulmonary arterial compliance (PAC) is an important determinant of right ventricle (RV) workload and it is a strong predictor of survival in other forms of PH. The aim of this study is to investigate whether PAC is a predictor of long-term prognosis in a population of CF patients affected by advanced lung disease. Methods Between 2000 and 2014, 178 patients with CF have been evaluated for lung transplantation in our CF Center. Right heart catheterization (RHC) and follow up data were retrievable and analyzed in 141 of them. PAC was defined as the ratio between stroke volume (SV) and pulse pressure (PP) at heart catheterization. The association of PAC with survival was tested at 4years and compared to other hemodynamic parameters. Results PH prevalence was 56.4%. Most patients had mild elevation of pulmonary artery pressure (PAP). No difference in mortality was observed in patients with PH compared to patients with normal PAP (HR 0.95: 95% CI 0.49–1.89, p =0.89). At receiver operating characteristic curve (ROC) analysis, the optimal prognostic cut-off point of PAC was 1.95ml/mmHg. An impaired PAC (≤1.95ml/mmHg) was a strong independent predictor of long-term mortality (HR 3.44: 95% CI 1.51–7.85: p =0.003). Conclusions Impaired PAC is associated with poor prognosis in CF patients awaiting lung transplantation. Other traditional hemodynamic parameters add no prognostic information.

This study analyses dynamicchangesin dispersion of ventricularrepolarization over the time course of takotsubo cardiomyopathy (TC), and their relationships with clinical features and life-threatening arrhythmias.All consecutive patients admitted to our division between January 2008 and December 2011 with a diagnosis of TC were analysed. Patients with prior myocardial infarction, symptoms-onset-to-admission time greater than 12 hours, an implanted pacemaker, or under treatment with drugs affecting QTinterval, were excluded. Standard 12-lead ECG recordings during the acute, subacute and chronic phases were collected for each patient. Twenty-four patients (23 women, 63 +/- 14 years) were includedin our analysis. Only one patient experienced ventricular arrhythmias (4.2%). Significant increases were observed in QT and QTc intervals (from 420 ?423 to 505 +/- 66 ms, P0.00001, and from 479 +/- 33 to 551 +/- 51 ms, P0.00001, respectively), QTdispersion (from 59 +/- 18 to 100 +/- 44 ms, P=0.0006), Tpeak-to-Tend (from 82 +/- 20 to 123 +/- 39 ms, P=0.00006) and Tpeak-to-Tend/QT (from 0.20 +/- 0.33 to 0.26 +/- 0.57, P=0.0003) during the subacute phase. All these parameters returned to baseline values in the chronic phase and did not show any significant differences between the acute and chronic phases.A marked increase in QTc, QT dispersion, Tpeak-to-Tend and Tpeak-to-Tend/QT was observed during the subacute phase; this increase was transient and reverted in allpatients before hospital discharge. Ofnote, these findings were not associated with an increased risk of life-threatening arrhythmias.

AIMS To compare the performance of instantaneous wave-free ratio (iFR) with fractional flow reserve (FFR) in a real-life, prospective, single-center, and independent study. METHODS AND RESULTS Fifty-four patients were included and 89 angiographic intermediate lesions underwent functional evaluation with both iFR and FFR. FFR was used as the gold standard, and the patients having FFR values 0.80 or less only underwent percutaneous coronary intervention. Linear regression demonstrated close agreement between the two techniques (R = 0.83, P

The best therapeutic strategy for patients with concomitant carotid obstructive disease (COD) and coronary artery disease (CAD) remains controversial. The aim of the study is to observe post-procedural and 1-year clinical outcomes of patients with COD and CAD after an endovascular, surgical, or a combined (hybrid) revascularization approach, selected by consensus of a multidisciplinary team. Between January 2006 and December 2012, 1043 consecutive patients with COD and concomitant CAD were treated. According to treatment strategies, patients were divided into three groups: surgical: 391 patients (37.1%), endovascular: 502 (48.1%), and hybrid (combined surgical and percutaneous revascularization): 129 (12.4%). The remaining 21 patients were managed medically only and not analysed. The primary end point of the study was a composite of death, myocardial infarction (MI), and stroke at 1-year follow-up; secondary end points included a composite of death, MI, and stroke in-hospital, and major bleeding complications. In hospital, mortality was higher in the surgical group (2.3 vs. 0.2 and 0%, P < 0.001), more strokes occurred in the endovascular group (2.0 vs. 0.5 and 0.8%, P = 0.03), and major bleedings were more frequent among hybrid patients (13.9 vs. 3.8 and 5.5%, P = 0.001). The incidence rate of the primary end point (hierarchical at 1 year) occurred in 6.0% of the study population (5.8, 6.5, and 4.6%, respectively; P = ns for all groups). Surgical and endovascular treatments yield remarkable clinical results both at acute and 1-year follow-up. The best-suited revascularization strategy should be discussed in a multidisciplinary context, and chosen according to the clinical characteristics of each single case and local expertise.

Many high risk (HR) percutaneous coronary interventions (PCI) are being performed with mechanical cardiac assistance. The data available demonstrated safety and feasibility of HR-PCI under Impella-pump protection (pIMP). However, poor data exist about outcome predictors in HR procedures. We

Renal sympathetic denervation (RSD) is emerging as a new therapeutic option for patients with severe hypertension refractory to medical therapy. Patients affected by renovascular or anatomical abnormalities have hitherto been systematically excluded from clinical trials with RSD because of concern about safety and the unknown efficacy of the procedure in this subgroup of patients. We describe the management of a case of RSD in a single-kidney patient with refractory hypertension; the patient had had a previous surgical right nephrectomy for renal cell carcinoma that subsequently required no other oncologic treatment. After multidisciplinary assessment, the patient underwent RSD. The procedure was performed through a 6F femoral access using the Symplicity™ RSD system (Medtronic, Mountain View, CA, USA). Radiofrequency was applied to the renal artery wall in 6 different points under general sedation with midazolam to control back pain caused by the procedure, that was performed without periprocedural complications. The patient was discharged 2 days later after a control of the vascular access site and routine biochemical examinations. The following 9-month follow up showed a significant reduction in blood pressure and stable renal function, without signs of renal damage. Our report confirms the feasibility of RSD in this delicate context, without evident negative effects on kidney function and with a significant reduction in blood pressure. Future studies are needed to fully clarify the value of RSD in single-kidney patients.

Two weeks after dual-chamber pacemaker implantation, a 51-year-old man presented typical signs of pacemaker pocket infection and sharp pain in the left shoulder with functional impotence of the limb. Device and leads …

A man with severe rheumatic trivalvular disease was treated with surgical implantation of mechanical aortic and mitral prostheses at the age of 30 years and tricuspid bioprosthesis at the age of 50 years. At 61 years of age, he developed severe symptomatic tricuspid regurgitation due to bioprosthesis degeneration and was judged at very high risk for a third surgical approach. The investigators describe the successful transfemoral positioning of a 29-mm Edwards SAPIEN XT percutaneous valve inside the degenerated tricuspid prosthesis, with excellent acute results and no major complications. In conclusion, percutaneous valve-in-valve treatment of degenerated bioprostheses is feasible by the transfemoral route and may be of assistance in very selected patients at high surgical risk.

Late and very-late stent occlusion remains a serious complication of coronary stenting. Despite their high anti-restenotic efficacy, drug-eluting stents (DES) have been associated to more late-thrombosis as compared to bare-metal stents (BMS). The aim of this study is to analyze the clinical presentation, angiographic, and intravascular ultrasound (IVUS) findings in patients with late or very late stent thrombosis and the relationship with the antiplatelet regimen.Between January 2007 and December 2011, 34 consecutive patients with clinical syndromes compatible with late or very-late stent occlusion were studied with IVUS during emergency catheterization; 25 had DES and 9 had BMS. Thrombotic total occlusion was more common in DES (16 = 64%) than BMS patients (2 = 22%; P = 0.02) and ST-segment elevation myocardial infarction was the predominant clinical presentation in the former group (60% compared to 22%; P = 0.05). The time elapsed between implantation and failure was much longer in DES patients: 33 ± 22 versus 17 ± 14 months for BMS; P = 0.05. IVUS analysis showed a higher incidence of incomplete stent apposition (ISA) in the DES group compared to the BMS group (56% vs. 11%; P = 0.005) and in-stent plaque rupture was the most common finding in the BMS group (78%). In DES group, ISA was found more frequently in patients still under dual antiplatelet therapy (71%).Very late DES failure often causes ST-elevation myocardial infarction; these very late events may not correlate with the interruption of antiplatelet therapy. Severe, late acquired ISA belongs to DES and is frequently observed in patients with very late DES thrombosis.

Aortic valve stenosis (AVS) may influence fractional flow reserve (FFR) of concomitant coronary artery disease (CAD) by causing hypertrophy and reducing the vasodilatory reserve of the coronary circulation. The hypothesis was made that TAVI, changing ventricular function by eliminating valvular

Fractional flow reserve (FFR) and instantaneous wave-free ratio (iFR) have not been extensively investigated in patients with severe aortic valve stenosis(AVS) and concomitant coronary artery disease(CAD). The aim of this study was to compare FFR and iFR measurements in patients with severe

Objective The use of transcatheter aortic valve implantation (TAVI) is growing rapidly in countries with a predominantly elderly population, posing a huge challenge to healthcare systems worldwide. The increment of human and economic resource consumption imposes a careful monitoring of clinical outcomes and cost-benefit balance, and this article is aimed at analysing clinical outcomes related to the TAVI learning curve. Methods Outcomes of 177 consecutive transfemoral TAVI procedures performed in 5 years by a single team were analysed by the Cumulative Sum of failures method (CUSUM) according to the clinical events comprised in the Valve Academic Research Consortium (VARC-2) safety end point and the VARC-2 definition of device success. Margins for events acceptance were extrapolated from landmark trials that tested both balloon or self-expandable percutaneous valves. Results 30-day and 1-year survival rates were 97.2% and 89.9%, respectively. Achievement of the primary end point (number of cases needed to provide the acceptable margin of the composite end point of any death, stroke, myocardial infarction, life-threatening bleeding, major vascular complications, stage 2–3 acute kidney injury and valve-related dysfunction requiring a repeat procedure) required the performance of 54 cases, while the learning curve to achieve ‘device success’ identified 32 cases to reach the expected proficiency. In this experience, the baseline clinical risk as assessed by the Society of Thoracic Surgeons (STS) score determined the long-term survival rather than the adverse events related to the learning curve. Conclusions A relatively large number of cases are required to achieve clinical outcomes comparable to those reported in high-volume centres and controlled trials. According to our national workload standards, this represents more than 2 years of continuous activity.

Transfemoral aortic valve implantation has recently emerged as a therapeutic option for patients with symptomatic, severe aortic stenosis for whom standard surgical aortic valve surgery is not suitable. Aortic valvuloplasty and valve positioning is normally performed under fluoroscopy and requires several injections of contrast medium. In critically ill patients with advanced renal insufficiency, contrast media administration can further increase renal damage; therefore, an echocardiogram and fluoroscopy-guided procedure, using the calcified contours of the stenotic aortic valve as a landmark may be a useful alternative. We report the first successful transfemoral aortic valve implantation procedure performed under fluoroscopy and transesophageal echocardiogram control, without administration of contrast medium injections in a patient with severe renal insufficiency and multiorgan failure.

Transcatheter aortic valve implantation (TAVI) has nowadays been introduced as an alternative for surgical aortic valve replacement as a treatment for high risk aortic stenosis patients. This procedure is not free of complications: the SOURCE registry, indeed, showed that vascular complications are more frequent with the transfemoral approach. We present the case of an 82-year-old man with known history of severe aortic stenosis at high-risk for surgery. Pre-TAVI screening shows bilateral severely tortuous iliac arteries and aorto-bi-iliac endoprosthesis. Transapical TAVI as a first choice was rejected due to severe lung disease. The patient was then treated by Transfemoral TAVI using a dedicated interventional technique that is described in this case-report.

BACKGROUND The diagnostic accuracy of serum creatinine and cystatin C (Cys) as early predictors of contrast-induced nephropathy (CIN) has been debated. We investigated the diagnostic sensitivities, diagnostic specificities, and variations from baseline for serum creatinine and Cys in CIN. METHODS We prospectively evaluated 166 patients at risk for CIN at baseline, and at 12, 24, and 48 h after exposure to contrast media. CIN occurred in 30 patients (18%). Changes (Δ) compared to baseline in serum creatinine and Cys were evaluated at the predefined time points. ROC curve analysis was performed for the Δ 12-h basal serum creatinine and Cys. RESULTS The Δ serum creatinine at 12 h from baseline was the earliest predictor of CIN [area under the ROC curve (AUC) = 0.80; P < 0.001]. The Δ serum creatinine 15% variation [0.15 mg/dL (13.2 μmol/L)] yielded 43% diagnostic sensitivity and 93% diagnostic specificity. The ΔCys at 12 h from baseline performed significantly worse than serum creatinine (AUC = 0.48; P = 0.74). CONCLUSIONS Variations from the serum creatinine baseline offer better diagnostic accuracy for predicting CIN at an earlier stage than similar variations in Cys. An additional diagnostic value of Cys over the determination of serum creatinine in the setting of CIN was not observed.

To the Editor: On May 18, 2010, Briguori et al reported in Circulation that “in patients with chronic kidney disease, cystatin C seems to be a reliable marker for the early diagnosis and prognosis of contrast-induced nephropathy (CIN).”1 The authors investigated whether changes in cystatin C levels 24 hours after contrast media exposure anticipate the occurrence of CIN (absolute increment of serum creatinine [SC] ≥0.3 mg/dL at 48 hours), and if this could predict 12-month major adverse events such as death and need for dialysis. They found that a 24-hour increment in cystatin C levels ≥10% compared with baseline is a good predictor of CIN, with excellent negative predictive value (100%) and …

Background Prednisone at immunosuppressive doses after stenting has shown remarkable efficacy in reducing ischemic recurrences in nondiabetic patients with high post-procedural levels of C-reactive protein; the study aim was to compare the clinical outcome obtained in a control group of patients treated with bare metal stents versus 2 other study groups—bare metal stent plus oral prednisone or drug eluting stents—assuming similar optimal adjunctive medical treatment. Methods Five tertiary Italian hospitals enrolled 375 nondiabetic patients with coronary artery disease and no contraindications to dual antiplatelet treatment or corticosteroid therapy in a randomized, controlled study performed between 2007 and 2009. Patients were allocated into 3 study groups: bare metal stents (controls), bare metal stents followed by a 40-day prednisone treatment, or drug-eluting stents. The primary endpoint was the event-free survival of cardiovascular death, myocardial infarction, and recurrence of ischemia needing repeated target vessel revascularization at 1 year as adjudicated by an independent clinical events committee. Results One-year follow-up was obtained in all patients. Patients receiving bare metal stents alone as compared to those treated with prednisone or drug-eluting stents had lower event-free survival; the primary endpoint was 80.8% in controls compared to 88.0% in the prednisone and 88.8% in the drug-eluting stent groups, respectively ( P =.04 and .006). Conclusion Compared with bare metal stents alone, prednisone treatment after bare metal stents or drug-eluting stent implantation result in a better event-free survival at 1 year.

Objective Atherosclerosis and restenosis are largely ruled by inflammation. The aim of this study was to test the effects of a short-course, high-dose oral prednisone on the release of interleukin-6 (IL-6) and tumour necrosis factor (TNF)-α from circulating monocytes and on the neointimal growth that follows bare metal stent (BMS) implantation. In a sub-group of patients activated NF-κB was also evaluated. Methods Out of 40 patients with coronary artery disease treated with BMS implantation, 20 were randomly assigned to receive oral prednisone during 40 days according to a standardized protocol. In non-stimulated and stimulated (LPS and PMA) monocytes we evaluated the release of IL-6 and TNF-α, and NF-κB p50 subunit translocation at baseline, at 10 and 30 days. Late luminal loss (LLL) 9 months after angioplasty was calculated by quantitative coronary angiography. Results Plasma concentrations of prednisone correlated inversely with IL-6 and TNF-α release ( R 2 =0.45, p =0.04 and R 2 =0.69, p =0.005, respectively) and NF-κB activation from monocytes ( R 2 =0.58, p =0.01). The reduction of TNF-α release and NF-κB activation were significantly related ( R 2 =0.56, p =0.01). Prednisone patients showed a significantly larger reduction of cytokine release and NF-κB activation compared to non-treated patients, at 10 days and 30 days. LLL was lower in the prednisone group (0.44±0.35mm versus 0.80±0.53mm, p =0.02) and correlated with reduction of TNF-α ( R 2 =0.41, p =0.01). Conclusions High doses of oral prednisone reduce NF-κB pathway activation and pro-inflammatory cytokine release in circulating activated monocytes of patients treated with coronary stenting. TNF-α release reduction correlates with decreased LLL.

The purpose of this study was to evaluate incidence and predictors of contrast-induced nephropathy after coronary angiography and interventions, and to assess renal function at 30 days. The prognostic value of any early shift of serum creatinine compared with baseline was investigated; such measurement, being a delta, is largely independent of creatinine variations.There were 216 patients at risk for contrast-induced nephropathy prospectively evaluated at baseline and at 12, 24, and 48 hours after exposure to contrast media, and 190 (88%) evaluated 1 month after discharge.Contrast-induced nephropathy occurred in 39 patients (18%), and 30-day renal damage was detected in 15 (7%). Contrast media/kg volume predicted contrast-induced nephropathy (P=.002), and percentage change of creatinine 12 hours from baseline was significantly higher in patients with nephropathy (P.001). At multivariate analysis, percentage change of creatinine 12 hour-basal was the best predictor of nephropathy (P.001). A 5% increase of its value yielded 75% sensitivity and 72% specificity (area under the curve 0.80; odds ratio 7.37; 95% confidence interval, 3.34-16.23) for early contrast-induced nephropathy detection. Furthermore, it strongly correlated with the development of renal impairment at 30 days (P=.002; sensitivity 87%, specificity 70%; area under the curve 0.85; odds ratio 13.29; 95% confidence interval, 2.91-60.64).Minimal elevations of serum creatinine at 12 hours are highly predictive of contrast-induced nephropathy and 30-day renal damage after exposure to contrast media.

Background Several randomized trials and registries have shown a reduction of restenosis after coronary angioplasty with drug-eluting stents (DESs) compared with bare metal stents (BMSs). However, cost-efficacy analysis and long-term outcome of DESs compared to BMSs deserve further assessment. Moreover, concern has been raised regarding adverse clinical events occurring late after DES implantation, in particular, late stent thrombosis related to the suspension of dual antiplatelet therapy. The use of a short-cycle oral treatment with prednisone at immunosuppressive dose after BMS implantation has shown remarkable efficacy in reducing restenosis in nondiabetic patients, with very low additional cost and without the need for long-term dual antiplatelet therapy. Such results are however limited by small sample size. Study design Cortisone plus BMS or DES versus BMS alone to Eliminate Restenosis is an independent, prospective, multicenter, randomized study. It will randomize 375 nondiabetic patients with coronary artery disease in three different arms to BMS (control group), DES (DES group) or BMS followed by a 40-day prednisone treatment (prednisone group). The DES and the prednisone groups will be compared to the control group to investigate the expected clinical advantage. The primary endpoint of the study is the event-free survival of cardiovascular death, myocardial infarction and recurrence of ischemia-needing repeated target vessel revascularization at 1 year. Secondary endpoints are the event-free survival analysis at 2 and 3 years, the restenosis rate at 9 months, and cost-effectiveness at 1, 2 and 3 years. Sample size The expected primary endpoint rates are 90% for DESs and for prednisone-treated patients and 77% for BMSs. The study was designed as a superiority trial, to compare DES, and BMS and prednisone, with BMS alone. A sample size of 118 patients per group provides an 80% power, assuming a complete 12-month follow-up information available for each patient. To obviate for cases of drop out, the sample size was increased to 375 patients to be enrolled in five Italian hospitals. Conclusion This study will provide a magnitude of the net clinical and economic benefits of DES and of the safety and efficacy of BMS and cortisone compared to the standard use of BMS alone in nondiabetic patients with coronary artery disease.

In-stent thrombosis is a severe and potentially fatal event. The incidence of this pathological process does not differ significantly after implantation of either bare metal or drug-eluting stents (DESs) in the first month after intervention, but stent thrombosis (ST) continues to occur over a long period of time after implantation of DESs, a phenomenon known as late and very late ST. Multiple predictors of late ST have been identified, and among others, patient's adherence to medical therapy as well as an optimal interventional technique of stent implantation emerge as crucial variables. Scarce data is available about the occurrence of recurrent very late ST. We report three cases of recurrent very late thrombosis of first generation DESs in middle-aged patients with different degrees of coronary artery disease, presenting with acute myocardial infarction.

Due to the increased life expectancy derived from better conditions of life and improved medical technology, interventional cardiologists are facing challenging procedures in older and much more delicate patients, in whom percutaneous coronary intervention is generally considered less dangerous than cardiac surgery. We present two recent cases of high-risk complete myocardial revascularization in patients older than 80 years assisted by the Impella Recover 2.5. In our initial experience this device proved to be relatively easy to set up and hemodynamically useful for patients with left ventricular dysfunction and end-stage coronary atherosclerosis.

Although the utility of stress echocardiography for the diagnosis and prognostic evaluation of patients with suspected coronary artery disease (CAD) has been widely reported, few studies have evaluated the role of revascularization in relation to the presence of inducible ischemia during stress in patients with known CAD. The study population consisted of 295 consecutive patients who underwent transesophageal atrial pacing stress echocardiography (TAPSE) in the echocardiographic laboratory of our division between January 1988 and September 1997, in whom coronary angiography was performed within 10 days of the test. Patients were then assigned to revascularization or medical treatment according to the treatment given within 60 days of TAPSE. Cardiac-related deaths were higher in medically treated (19 of 135) than in revascularized (8 of 160) patients (p = 0.03). Parameters measured with TAPSE, i.e., positivity of the test, change in wall motion score index (DeltaWMSI and peak WMSI) were significantly related to mortality in medically treated patients but not in revascularized patients. At multivariate analysis, DeltaWMSI remained the most powerful predictor of cardiac death in medically treated patients (p = 0.005). Mortality progressively increased with increments in extent of inducible ischemia among medically treated patients (5 of 71 patients in DeltaWMSI 0, 3 of 27 in DeltaWMSI 0 to 25, 11 of 37 patients in DeltaWMSI25) but not among revascularized patients (3 of 58 patients in DeltaWMSI 0, 2 of 51 in DeltaWMSI 0 to 25, 3 of 51 patients in DeltaWMSI25). The survival curve in medically treated patients with ischemia in a remote zone (24 patients, 8 deaths) was worse than in other groups of medically treated patients (41 patients, 6 deaths). In conclusion, in patients with known CAD, the presence and extent of ischemia as evaluated with TAPSE worsens survival, if revascularization is not performed. In patients without ischemia at TAPSE, revascularization or medical therapy are equally effective.

Ageing, and the ever-increasing complexity of medical care requires an accurate assessment of the clinical advantages of treatments in relation to economic burden. A highly rated and conceptually simple indicator of this "weighed" intervention is the number needed to treat (NNT). Treating inoperable

Acute coronary syndromes (ACS) represent a life-threatening complication of the systemic atherosclerotic process, affecting the coronary circulation. Thrombosis, defined as an uncontrolled activation of the endogenous thrombogenetic reparative process, often follows atherosclerotic plaque damage and is mainly engaged by two main pathways: platelet aggregation and coagulation. Therefore, antithrombotic therapy to modulate either pathway plays an important role for the reduction of ischaemic adverse events in ACS patients. Since the advent of aspirin and warfarin, numerous antiaggregant and anticoagulant molecules have been developed to achieve this goal, but their anti-ischaemic efficacy is often obtained at the price of augmented bleedings, which are known to be strong predictors of adverse outcome. This article briefly reviews the physiopathological mechanisms of thrombosis and presents an overview of the available literature supporting the use of these major drugs, as well as the European Society of Cardiology recommendations for their utilisation in the setting of non-ST and ST-elevation myocardial infarction undergoing invasive treatment.