Gaetano Gioffrè

Major improvement of percutaneous cardiovascular procedure outcomes with radial artery catheterisation: results from the PREVAIL study

Objective: To obtain a “snapshot” view of access-specific percutaneous cardiovascular procedures outcomes in the real world. Design: Multicentre, prospective study performed over a 30-day period. Setting: Nine hospitals with invasive cardiology facilities, reflecting the contemporary state of healthcare. Patients: Unselected consecutive sample of patients undergoing any percutaneous cardiovascular procedure requiring an arterial access. Interventions: Percutaneous cardiovascular procedures by radial or femoral access Main outcome measures: The primary outcome was the combined incidence of in-hospital (a) major and minor haemorrhages; (b) peri-procedural stroke; and (c) entry-site vascular complications. The secondary outcome was the combined incidence of in-hospital death and myocardial infarction/reinfarction. For analysis purposes, outcomes were allocated to arterial access-determined study arms on an intention-to treat basis. Multivariable analysis adjusted using propensity score was performed to correct for selection bias related to arterial site. Results: A total of 1052 patients were enrolled: 509 underwent radial access and 543 femoral access. In both groups, 40% underwent a coronary angioplasty. Relative to femoral access, radial access was associated with a lower incidence both of primary (4.2% vs 1.96%, p = 0.03, respectively) and secondary endpoints (3.1% vs 0.6%, p = 0.005, respectively). Multivariate analysis, adjusted for procedural and clinical confounders, confirmed that intention-to-access via the radial route was significantly and independently associated with a decreased risk both of primary (OR 0.37, 95% CI 0.16 to 0.84) and secondary endpoints (OR 0.14, 95% CI 0.03 to 0.62). Conclusions: Our study indicates strikingly better outcomes of percutaneous cardiovascular procedures with radial access versus femoral access in contemporary, real-world clinical settings.

Head-to-Head Comparison of Sirolimus-and Paclitaxel-Eluting Stent in the Same Diabetic Patient With Multiple Coronary Artery Lesions : A prospective, randomized, multicenter study

OBJECTIVE—It is still controversial whether sirolimus-eluting stent (SES) and paclitaxel-eluting stent (PES) are equally effective in patients with diabetes. In these patients, multiple individual variables may be responsible for neointimal hyperplasia, thus making difficult the comparison of the two drug-eluting stents (DES). RESEARCH DESIGN AND METHODS—We designed a prospective, randomized study to compare the efficacy in prevention of restenosis of SES and PES, both implanted in the same diabetic patient with multiple de novo coronary artery lesions undergoing elective percutaneous coronary intervention. We enrolled 60 patients with diabetes with at least two significant de novo angiographic stenoses in different coronary segments. The primary end point was in-stent late luminal loss (LLL) at 8-month angiographic follow-up. RESULTS—A total of 120 lesions were successfully treated with the randomly assigned DES (SES, n = 60; PES, n = 60). In-stent LLL was lower in the SES than in the PES group (0.26 ± 0.4 vs. 0.50 ± 0.6 mm; P = 0.01). Coronary lesions treated with SES presented a reduced in-stent LLL in 40 (68%) patients, while PES resulted in a lower in-stent LLL in 19 (32%) patients (P = 0.0002). At multivariable analysis, the type of DES implanted was the only independent predictor of in-stent LLL (odds ratio 2.3 [95% CI 1.1–5.0]; P = 0.03). CONCLUSIONS—SES directly compared with PES in the same diabetic patient is associated with a decrease in the extent of in-stent LLL at 8 months, suggesting a reduced risk of restenosis.

Usefulness of Transcatheter Patent Foramen Ovale Closure in Migraineurs With Moderate to Large Right-to-Left Shunt and Instrumental Evidence of Cerebrovascular Damage

Transcatheter patent foramen ovale (PFO) closure might be effective in improving migraines. To assess the efficacy of PFO closure in migraineurs with a moderate to large right-to-left shunt and instrumental evidence of embolic cerebral damage, 76 highly symptomatic migraineurs were prospectively investigated. The presenting clinical syndrome was stroke in 16 patients, repeated transient ischemic attack in 32 patients, and lone migraine associated with cerebral ischemic lesions on magnetic resonance imaging in 28 patients. Migraine severity was assessed before PFO closure and monthly for 6 months after discontinuation of antiplatelet therapy. At the end of 12 months of follow-up, the averaged postprocedural total score was compared with the baseline score. Transcatheter PFO closure was successful in all patients, and the 12-month PFO closure rate was 97%. The baseline total migraine score was similar in patients with stroke, transient ischemic attack, and lone migraine (6.8 +/- 1.6, 6.7 +/- 1.4, and 6.9 +/- 1.7 respectively, p = NS). After a mean follow-up of 13.7 +/- 2.4 months, no recurrent cerebrovascular episodes had occurred. At the end of the follow-up period, a significant reduction in the total migraine score was observed in all groups, regardless of the initial clinical presentation. Migraine was completely abolished in 35 patients (46%), improved in 27 (36%), and unchanged in 14 (18%). The proportion of patients with migraine suppression and improvement was similar in the 3 groups. In conclusion, in highly symptomatic migraineurs with previous ischemic cerebral events and instrumental evidence of cerebral embolism, transcatheter PFO closure can result in improvement of migraine severity in a high percentage of patients.

Twenty year follow-up after successful percutaneous balloon mitral valvuloplasty in a large contemporary series of patients with mitral stenosis

BACKGROUND Percutaneous balloon mitral valvuloplasty (PMV) is currently considered the standard of care for suitable patients with rheumatic mitral stenosis. We sought to assess very long-term outcome after PMV. METHODS Between 1991 and 2010, 482 consecutive patients underwent successful PMV in a single center. Procedural success was defined as post-procedural valve area ≥ 1.5 cm(2) and regurgitation moderate or less, without in-hospital major adverse cardiac and cerebro-vascular events. The primary endpoint was 20-year incidence of major adverse cardiac events (MACE), including cardiovascular death and need for mitral surgery or repeat PMV. RESULTS Long-term follow-up (mean 11.6 ± 4.9 years; range 0.5 to 20) was completed in 441 (91.5%) patients. The incidence of the primary endpoint was 41.9% (95% confidence interval [CI]: 37.3 to 46.7%). The rate of cardiovascular death, need for mitral surgery or repeat PMV was 9.1% (95% CI: 6.6 to 12.1), 27% (95% CI: 22.9 to 31.4), and 5.9% (95% CI: 3.9 to 8.5), respectively. Cumulative MACE-free survival at 20 years was 35.9 ± 4.7%. At multivariate analysis, male gender (hazard ratio [HR]: 1.99; 95% CI: 1.4-2.8, p < 0.001), echocardiographic score > 8 (HR: 2.19; 95% CI: 1.6-2.9, p < 0.001), atrial fibrillation (HR: 1.54; 95% CI: 1.2-2.1, p = 0.003) and valve area ≤ 1.75 cm(2) after PMV (HR: 3.1; 95% CI: 2.3-4.2, p < 0.001) were identified as independent predictors of the primary endpoint. CONCLUSIONS Up to 20 years after successful PMV, a sizeable proportion of patients still exhibit a good clinical result.

Comparison of the feasibility and effectiveness of transradial coronary angiography via right versus left radial artery approaches (from the PREVAIL Study)

It remains undefined if transradial coronary angiography from a right or left radial arterial approach differs in real-world practice. To address this issue, we performed a subanalysis of the PREVAIL study. The PREVAIL study was a prospective, multicenter, observational survey of unselected consecutive patients undergoing invasive cardiovascular procedures over a 1-month observation period, specifically aimed at assessing the outcomes of radial approach in the contemporary real world. The choice of arterial approach was left to the discretion of the operator. Prespecified end points of this subanalysis were procedural characteristics. Of 1,052 patients consecutively enrolled, 509 patients underwent transradial catheterization, 304 with a right radial and 205 with a left radial approach. Procedural success rates were similar between the 2 groups. Compared to the left radial group, the right radial group had longer procedure duration (46 ± 29 vs 33 ± 24 minutes, p <0.0001) and fluoroscopy time (765 ± 787 vs 533 ± 502, p <0.0001). At multivariate analysis, including a parsimonious propensity score for the choice of left radial approach, duration of procedure (beta coefficient 11.38, p <0.001) and total dose-area product (beta coefficient 11.38, p <0.001) were independently associated with the choice of the left radial artery approach. The operators proficiency in right/left radial approach did not influence study results. In conclusion, right and left radial approaches are feasible and effective to perform percutaneous procedures. In the contemporary real world, however, the left radial route is associated with shorter procedures and lower radiologic exposure than the right radial approach, independently of an operators proficiency.

Feasibility and safety of transcatheter closure of atrial septal defects with deficient posterior rim.

To evaluate the feasibility and safety of percutaneous closure of complex secundum‐type atrial septal defects (ASD) in patients with posterior‐inferior rim deficiency.

Effect of Percutaneous Closure of Patent Foramen Ovale on Post-Procedural Arrhythmias

To the Editor: Atrial arrhythmias after percutaneous patent foramen ovale (PFO) closure, including atrial fibrillation (AF), has been consistently reported in different series suggesting a causal link between mechanical closure of PFO and the new onset of post-procedural arrhythmias [(1–3)][1].

The use of functional tests and planned coronary angiography after percutaneous coronary revascularization in clinical practice. Results from the AFTER multicenter study

BACKGROUND The follow-up strategies after percutaneous coronary intervention (PCI) have relevant clinical and economic implications. The purpose of this prospective observational multicenter study was to evaluate the effect of clinical, procedural and organizational variables on the execution of functional testing (FT) and planned coronary angiography (CA) after PCI, and to assess the impact of American College of Cardiology (ACC)/American Heart Association (AHA) guidelines on clinical practice. METHODS Four hundred twenty consecutive patients undergoing PCI were categorized as class I, IIB and III indications for follow-up FT according to ACC/AHA guidelines recommendations. Furthermore, all patients were grouped according to the presence or absence of FT and/or planned CA over 12 months after PCI. Multivariable analysis was used to assess the potential predictors of test execution. RESULTS During the 12-month follow-up at least one test was performed in 72% of patients with class I indication, 63% of patients with class IIB indication and 75% of patients with class III indication (p=ns). A total of 283 patients (67%) underwent testing. The use of tests was associated with younger age (R.R. 0.94, C.I. 0.91+/-0.97, p<0.001), a lower number of diseased vessels (R.R. 0.60, C.I. 0.43+/-0.84, p=0.003), follow-up by the center performing PCI (R.R. 2.64, C.I. 1.43+/-4.86, p=0.002), and the specific center at which PCI was performed. Most asymptomatic patients completed their testing prematurely with respect to the risk period for restenosis. CONCLUSIONS The use of FT and planned CA after PCI is unrelated to patients symptom status, and depends on patients age and logistics. ACC/AHA guidelines have no influence in clinical practice, and test timing is not tailored to the risk period for restenosis.

First ad hoc bioresorbable vascular scaffold bench test: a glimpse into percutaneous bifurcation interventions.

The advent of a fully bioresorbable stent has been advocated as a breakthrough in interventional cardiology [1]. After transiently assuring radial strength, this device is fully resorbed, leading to restoration of the vessels biological properties. However, although representing a truly innovative technology, the evolutionary impact of the bioresorbable vascular scaffold (BVS) appears somewhat shadowed by its intrinsic polymeric nature, which is not designed to tolerate the mechanical stresses that metallic stents typically endure during percutaneous bifurcation interventions. Indeed the Instruction For Use (IFU) of ABSORB (Abbott Vascular, Santa Clara, CA), the only commercially availableBVS, state to “avoid scaffolding across any sidebranch≥2 mmin diameter” because “balloon dilation of any cells of a deployed BVS will cause scaffold damage”. Nevertheless, the availability of the BVS in an increasing number of catheterization laboratories has entailed a more liberal use of the device engendering the feeling that manufacturers recommendations are excessively restrictive. Coupled to the rush for originality typically accompanying new technology, the lack of knowledge on the actual deformation capability of the BVS might be clinical harmful. Surprisingly, no bench test has been performed to date, possibly due to the high cost of the device and/or reluctance of the manufacturer to provide samples for such kind of investigation. We therefore take the opportunity of a non-implanted BVS to gain some insight into the structural features of this device, with special focus on its possible role in percutaneous bifurcation interventions. Because the IFU advised against reintroducing an ABSORB that has been retracted into the guiding catheter owing to the start of the polymer degradation process, we implemented a very simple bench test immediately after the end of the percutaneous coronary intervention, recycling the materials that have been used for the procedure. The test has been conducted in a liquid bath at body temperature (37 °C) to simulate the conditions in which the BVS inherent expansion occurs (Fig. 1A). All inflations were performed according to IFU, i.e. 2 atm increments every 5 s up to nominal pressure. After inflation of its delivery balloon, the expanded scaffold was placed over a stylet helping its manipulationwithout the need for touching. A cell was then crossed by a coronary guide wire and by a 2.5 mm diameter balloon (Fig. 1B) that was inflated. The BVS was then rapidly imaged. The scaffold showed mild dilation of the cell toward its external side with no apparent breaking of the structure (Fig. 2A and B). The same cell was further expanded with a 3.0 mm balloon inflation. Results showed a more significant modification of scaffold structure better revealing themechanism of cell dilation, i.e. up and down displacements of the ring arc delimiting the cell determining a small reduction of the scaffold internal caliber (Fig. 3A and B). To further assess the potential role of ABSORB in the treatment of bifurcation lesions, we over-expanded the segment starting from the dilated cell with a 3.5 mm and a 4.0 mm non-compliant balloon (respectively 0.5 mm and 1.0 mm larger than the nominal diameter of

AMPLATZER versus Figulla occluder for transcatheter patent foramen ovale closure

AIMS The aim of this observational study was to compare acute and 12-month results of percutaneous closure of patent foramen ovale (PFO) with two occluder devices. METHODS AND RESULTS Between June 2007 and October 2014, 406 consecutive patients (48.1±13.3 years, 243 women) underwent percutaneous PFO closure with either the AMPLATZER (n=179) or the Figulla (n=227) device after a stroke or a transient ischaemic attack ascribed to the PFO. A right-to-left shunt grade >1 was previously detected in all patients and atrial septal aneurysm was present in 111 (27.5%) patients. Patients were followed up with a contrast transthoracic echocardiogram and clinically at 24 hours, six months, and 12 months after the procedure. A high procedural success was observed in both groups. Despite a trend towards a higher incidence of acute residual shunt immediately after device deployment among Figulla occluder patients, a residual grade ≥2 right-to-left shunt was observed in 4.5% of patients, independently of the device used for PFO closure. The only difference reported after Figulla device implantation was a lower rate of supraventricular arrhythmias (9% vs. 17%, p=0.02). CONCLUSIONS According to this two-centre study, PFO closure appears safe and effective with the Figulla occluder as well as with the AMPLATZER device.