Alberta Cifarelli

Maintenance of Long-Term Clinical Benefit With Sirolimus-Eluting Stents in Patients With ST-Segment Elevation Myocardial Infarction: 3-Year Results of the SESAMI (Sirolimus-Eluting Stent Versus Bare-Metal Stent In Acute Myocardial Infarction) Trial

OBJECTIVES The aim of this study was to investigate whether the reported favorable 1-year outcome of the sirolimus-eluting stent (SES) versus the bare-metal stent (BMS) in the SESAMI (Sirolimus-Eluting Stent Versus Bare-Metal Stent In Acute Myocardial Infarction) trial, in the setting of ST-segment elevation myocardial infarction (STEMI), is maintained at 3-year follow-up. BACKGROUND At present, only long-term registry data, but not randomized trials, on the safety and effectiveness of SES in STEMI patients are available. METHODS Overall, 320 STEMI patients were randomized to receive SES or BMS. The primary end point was the incidence of major adverse cardiovascular events (MACE), at 3-year follow-up. The secondary end points were the rate of target lesion revascularization (TLR) and target vessel revascularization (TVR) and target vessel failure (TVF). The incidence of late events, starting from clopidogrel withdrawal, was also investigated. RESULTS The 3-year incidence of MACE was lower in the SES group compared with the BMS group (12.7% vs. 21%, p = 0.034), as were TLR (7% vs. 13.5%, p = 0.048), TVR (8% vs. 16%, p = 0.027), and TVF (11.5% vs. 20.5%, p = 0.028) rates. The 3-year survival rate free from MACE, TLR, and TVF was significantly higher in the SES group than in the BMS group (87%, 93%, and 89.5% vs. 79%, 86.5%, and 79.5%, respectively, p < 0.05). The lower incidence of adverse events in the SES group was driven by TLR reduction and achieved in the first year of follow-up. The cumulative incidence of death and recurrent myocardial infarction, starting from clopidogrel discontinuation, was comparable in the 2 groups. CONCLUSIONS The clinical benefits of SES have been shown to be greater than those of BMS at 3-year follow-up.

Endovascular treatment of aortic coarctation: Long-term effects on hypertension

INTRODUCTION Endovascular management of aortic coarctation (CoA) is safe but few data are available concerning the long-term cure of hypertension. Aim of this study was to evaluate immediate and long-term clinical and haemodynamic outcome in a consecutive series of adolescent and adult patients with CoA submitted to endovascular treatment. METHODS A total of 21 adolescent and adult patients underwent successful transcatheter intervention of CoA. Follow-up comprised cardiological examination with special attention to blood pressure (BP), echocardiogram, 24/h ambulatory blood pressure monitoring (ABP), exercise test and spiral computed tomography. RESULTS Pre-intervention CoA diameter and degree of stenosis were 4.8+/-2.1 mm and 73.7+/-9.8%, respectively, and 14.8+/-3.0 mm and 13.5+/-6.5% post-intervention (p<0.001). Systolic arterial hypertension persisted in 2 patients at rest (9.5%). Mean number of antihypertensive medications per patient was 1.5+/-1.1 and 0.5+/-0.9 at 1 year after treatment (p<0.05). At ABP 3 patients (14%) were hypertensive. The Doppler gradient across the coarctation site decreased from 58.8+/-16.9 to 10.5+/-4.9 mmHg (p<0.001) as well as left ventricular mass (199+/-14.6 and 189.3+/-9.1; p<0.001). Overall, 18 patients (86%) underwent a treadmill exercise test and 4 patients (22%), normotensive at rest, showed a pathological blood pressure response. Overall, 7/21 patients (33%) showed persistent hypertension. CONCLUSION Endovascular treatment of native or recurrent CoA in adolescent and adult patients is safe but 33% of patients showed persistent hypertension. Meticulous clinical follow-up is mandatory, including an exercise test in order to monitor eventual blood pressure increase and to assess effort tolerance.

Patent foramen ovale and cryptogenic stroke. A critical review.

The underlying causes of ischemic stroke in young patients are often difficult to find, despite systematic investigations concerning heart, coagulation system or any other type of vascular disease, thus the definition of ‘cryptogenic’. In patients with cryptogenic stroke, the prevalence of a patent foramen ovale is about 45%, versus 25% of the general healthy population, leading to many speculations about a potential role of intracardiac right-to-left shunts in determining ischemic cerebral disease. Since a possible mechanism has been thought to be paradoxical embolism, percutaneous closure of the foramen ovale is currently discussed, at least until the appearance of data from the ongoing randomized trials. However, recurrent paradoxical embolism in patients with an aneurysmal atrial septum and a patent foramen ovale is currently the only unequivocal indication for percutaneous closure. Professional divers may benefit from the procedure as well, whereas migraine is still not considered an indication. In the pediatric population, closure of the patent foramen ovale seems to be safe and effective to prevent recurrent stroke. As the complication rate for device implantation decreases, the threshold for percutaneous closure is likely to decline.

Transcatheter closure of coronary artery fistula using the new Amplatzer vascular plug and a telescoping catheter technique.

Coronary artery fistulas (CAFs) are rare congenital or acquired anomalies characterized by an abnormal communication between the coronary arteries and the cardiac chambers or great vessels. Most patients are asymptomatic during childhood but symptoms and complications have been reported with advancing age. Until recently, surgery was the routine mode of treatment for CAFs but, today transcatheter closure is recommended using a variety of devices, such as occlusion coils, vascular plugs, umbrella devices and covered stents. The case described here is of a 47-year-old woman with a large bilateral CAF draining into the pulmonary artery, successfully treated by implantation of two Amplatzer vascular plugs using a telescoping catheter technique.

Oversize balloon atrial septal dilatation: Early experience

The introduction of Rashkind balloon atria1 septostomy (BAS)’ considerably improved the chances of survival of newborns with transposition of the great arteries (TGA). In the current era, BAS continues to be employed in the treatment of complex heart defects in patients with inadequate interatrial communication. In 1975, Park et a12, s first introduced the technique of blade atria1 septostomy to permit the opening of the atria1 septum in infants whose thick septum precluded the success of BAS. In these patients, the only alternative would be surgical septectomy. Recently, balloon dilatation of the atria1 septum has been described.4-7 We wish to report on our experience with a modification of this technique, that is, an atria1 septal dilatation with oversize balloon catheters (OBSD).8 Methods. Between September 1989 and April 1992, seven infants, aged 1.5 to 27 months (mean 11 months), underwent an OBSD procedure in our catheterization laboratory. Diagnoses were: transposition of the great arteries, ventricular septal defect, and pulmonary stenosis in three cases; double-outlet right ventricle with absent left atriovent.ricular (AV) connection and AV discordance (two cases); univentricular heart with left AV valve atresia and pulmonary stenosis (one case); and tricuspid atresia with ventriculoarterial concordance and pulmonary stenosis (one case). Indications for the procedure were arterial desaturation or heart failure in patients for whom surgical repair at the present stage was not advisable because of their young age. A common feature was a restrictive atria1 septal defect (2 to 4 mm) with a significant pressure gradient on two-dimensional and color Doppler echocardiography. In one patient (No. 5), who presented in severe heart. failure, the balloon septal dilatation was performed as an emergency procedure. After informed parental consent, a standard percutaneous catheterization procedure was performed under inhalatory anaesthesia obtained by mask administration of an 0.5

Transcatheter Closure of Mitral Paravalvular Leak with an Arteriovenous Wire Loop through an Aortic Mechanical Valve Prosthesis

0 to 1% mixture of halothane and oxygen; spontaneous breathing continued throughout the procedure in each case. Endotracheal intubation and me-

Percutaneous balloon dilatation of stenotic truncal valve in a newborn.

Percutaneous transcatheter closure of paravalvular leaks is an attractive treatment option in high risk symptomatic patients unsuitable for redo surgery. We present a case of a 64 year-old woman with double mechanical mitral and aortic valve prosthesis referred for a symptomatic mitral paravalvular leak. Because of the high surgical risk transcatheter closure of the defect was planned. The procedure was performed under real time 3D transoesophageal echocardiographic guidance via trans-septal approach. An Amplatzer Vascular Plug III 14 × 3 mm was implanted using an arteriovenous wire loop established through the aortic valve prosthesis. A transient dysfunction of the mitral prosthesis occurred, but it resolved spontaneously within few hours. Transcatheter paravalvular leak closure with an arteriovenous wire loop across a mechanical aortic valve prosthesis has never been described. We discuss the main technical issues.

Instantaneous wave-free ratio and fractional flow reserve for the assessment of nonculprit lesions during the index procedure in patients with ST-segment elevation myocardial infarction: The WAVE study

We describe the use of percutaneous balloon angioplasty of a stenotic truncal valve in a newborn with a common arterial trunk. A 12 mm balloon catheter was chosen, this representing 80% of the diameter of the ventriculo-truncal junction. The peak systolic gradient dropped from 45 to 15 mm Hg. The procedure can avoid, or certainly delay, surgical treatment of the stenotic truncal valve.

Comparison of One-Year Outcome of Patients Aged <75 Years Versus ≥75 Years Undergoing “Rescue” Percutaneous Coronary Intervention

Background Functional assessment of non–infarct‐related artery lesions during primary percutaneous coronary intervention (PCI) might be useful to avoid revascularization of nonsignificant stenosis and staged procedures, thus reducing hospital stay. We aimed to assess the diagnostic performance of instantaneous wave‐free ratio (iFR) as compared with fractional flow reserve (FFR) in this setting. Methods In the WAVE study, a prospective, observational, single‐center registry (NCT02869906), paired iFR and FFR measurements were performed at the level of non‐IRA lesions in patients with ST‐segment elevation myocardial infarction both during primary PCI and during staged procedures (5‐8 days after). Results Paired iFR and FFR measurements were available for 66 non‐IRA lesions in 50 patients. The iFR and FFR values of non‐IRA lesions did not change significantly between the index and staged procedure. Bland‐Altman analysis did not show systematic bias for either iFR or FFR repeated measures. Receiver operating characteristic curve analysis showed high accuracy of iFR to identify positive (≤0.80) FFR measurements in the index procedure with an area under the curve of 0.95. A cutoff of ≤0.89 for iFR in the index procedure had the best combination of sensitivity (95%) and specificity (90%) with positive and negative predictive values of 86% and 97%, respectively. Finally, iFR measured during the index procedure was significantly correlated with FFR (r = 0.71, r2 = 0.51; P < .0001). Conclusions The WAVE study shows that iFR yields similar diagnostic accuracy to FFR in functional evaluation of non‐IRA stenosis in patients with STEMI and multivessel CAD, with the advantage of being adenosine free.

Univentricular atrioventricular connection to a dominant left ventricle with a concordant ventriculo-arterial connection

The influence of age on the clinical results after rescue angioplasty (percutaneous coronary intervention [PCI]) has been poorly investigated. In the present study, we evaluated the outcome of 514 consecutive patients undergoing rescue PCI who were divided into 2 groups according to age: <75 years (n = 469) and ≥75 years (n = 45). The primary end point of the study was the incidence of death at 1 year of follow-up. The secondary end point was the 1-year incidence of major cardiac adverse events (MACE) defined as a composite of death, recurrent acute myocardial infarction, and target vessel revascularization. The predictors of death and MACE at 1 year were also investigated. At 1 year of follow-up, the <75-year-old group had a significantly lower incidence of death (7% vs 24%, p = 0.0001) and MACE (14% vs 28%, p = 0.01) compared to the ≥75-year-old group. The Cox proportional hazards model identified age (adjusted hazard ratio 0.2665, 95% confidence interval 0.1285 to 0.5524, p = 0.0004), cardiogenic shock (hazard ratio 0.1057, 95% confidence interval 0.0528 to 0.2117, p <0.000001), Thrombolysis In Myocardial Infarction flow grade 2 to 3 after PCI versus 0 to 1 (hazard ratio 3.8380, 95% confidence interval 1.7781 to 8.2843, p = 0.0006), multi- versus single-vessel disease (hazard ratio 0.3716, 95% confidence interval 0.1896 to 0.7284, p = 0.0039) as independent predictors of survival at 1 year of follow-up. In conclusion, at 1 year of follow-up after rescue PCI, the patients aged ≥75 years had a greater incidence of death and MACE compared to patients aged <75 years. Age, cardiogenic shock, Thrombolysis In Myocardial Infarction flow grade 0-1 after PCI, and multivessel coronary disease were predictors of survival and freedom from MACE at 1 year of follow-up.