[Drug-eluting stents in contemporary interventional practice: the STENT PANORAMA project (Part I)]. / Gli stent coronarici a rilascio di farmaco nella pratica interventistica contemporanea: progetto STENT PANORAMA (Parte I).

STENT PANORAMA is a project carried out by the Young Interventional Cardiologists of Triveneto coordinated by the Italian Society of Interventional Cardiology (GISE) Veneto delegation. The project includes two parts: the first, here reported, is aimed at describing in a standardized and easily usable way the main technological characteristics of the latest generation of the drug eluting stents (DES) that are most widely used in the Italian cath-labs. The second, to follow, will aim to summarize the main scientific evidence regarding the performance of individual devices with particular reference to subgroups of clinical interest. The ambitious goal of the STENT PANORAMA working group is to provide the interventional cardiologist with a thorough, practical, and functional knowledge of the DES currently available in the modern therapeutic armamentarium to promote a therapeutic strategy tailored to the patient.

Surgical redo versus transseptal or transapical transcatheter mitral valve-in-valve implantation for failed mitral valve bioprosthesis.

BACKGROUND: Redo surgical mitral valve replacement (SMVR) is the current standard of care for patients with failed bioprosthetic mitral valve (MV). Transcatheter mitral valve-in-valve replacement (TMViV) is arising as an alternative to SMVR in high risk patients. We sought to evaluate procedural safety, early and mid-term outcomes of patients who underwent transseptal TMViV (TS-TMViV), transapical TMViV (TA-TMViV), or redo-SMVR. METHODS: We identified patients with failed bioprosthetic MV who underwent TS-TMViV, TA-TMViV, or SMVR at four Italian Centers. Clinical and echocardiographic data were codified according to Mitral Valve Academic Research Consortium definition (MVARC), except for significant valve stenosis. RESULTS: Between December 2012 and September 27, 2019 patients underwent TS-TMViV, 22 TA-TMViV, and 29 redo-SMVR. TS-TMViV and TA-TMViV patients presented higher mean age and surgical risk scores compared with SMVR group (77.8 ± 12 years, 77.3 ± 7.3 years, 67.8 ± 9.4 years, p < .001; STS PROM 8.5 ± 7.2; 8.9 ± 4.7; 3.6 ± 2.6, p < .001). TS-TMViV procedure was associated with shorter intensive care unit time and total length of stay (LOS) compared with TA-TMViV and SMVR group. There were no differences in MVARC procedural success at 30-days (74.1, 72.7, and 51.7%, p = .15) and one-year all-cause mortality between groups (14.8, 18.2, and 17.2%, p = 1.0). MV mean gradient was similar between TS-TMViV, TA-TMViV, and SMVR groups at 30 days and 12 months. CONCLUSIONS: For the selected patients, TS-TMViV and TA-TMViV are to be considered a valid alternative to redo-SMVR with comparable 1-year survival. TS-TMViV is the less invasive strategy and has the advantage of shortening the LOS compared with TA-TMViV.

Percutaneous left atrial appendage closure in awake non intubated patient: Multimodality intraprocedural imaging.

We present a case of percutaneous left atrial appendage closure in awake non intubated patient, in which Intraprocedural ultrasound images were obtained with a micro transesophageal echocardiographic probe (MTEE) and intracardiac echocardiography (ICE) together with angiography.

Six-month results of a repositionable and retrievable pericardial valve for transcatheter aortic valve replacement: the Direct Flow Medical aortic valve.

OBJECTIVE: Transcatheter aortic valve implantation is considered an alternative for patients at high risk for conventional surgery. The Direct Flow Medical aortic valve (Direct Flow Medical, Inc, Santa Rosa, Calif) is a nonmetallic tissue valve prosthesis intended to treat patients with severe aortic stenosis at high risk for surgery. METHODS: Thirty-one patients at high surgical risk were enrolled in the trial (logistic EuroSCORE 28% ± 7%, Society of Thoracic Surgeons score 23% ± 9%). Twenty-two patients underwent successful retrograde transcatheter aortic valve implantation, and 9 patients did not undergo implantation owing to excessive calcifications or access issues. Mean preinterventional gradient and effective orifice area were 49 ± 14 mm Hg and 0.54 ± 0.16 cm(2), respectively, and 71% of patients were in New York Heart Association functional class III. RESULTS: Mean postprocedural gradient was 14.9 ± 5.5 mm Hg with an effective orifice area of 1.4 ± 0.31 cm(2). Two patients were converted to surgery and 2 patients died after implantation: 1 of myocardial infarction and 1 of congestive heart failure. One patient had a stroke 2 days after the procedure and 3 patients required a pacemaker. At 6 months the mean aortic valve gradient and effective orifice area were 19.8 mm Hg and 1.30 cm(2), respectively. The majority of patients had no paravalvular leak (58%) and 42% had grade 1/4 paravalvular leak; 69% were in New York Heart Association functional class I and 25% were in class II. The 3- and 6-month survivals were 87.1% and 80.6%, respectively (4/6 deaths in 31 patients). CONCLUSIONS: Transcatheter aortic valve implantation using the study valve appears safe and results are promising at 6 months. Severe leaflet and left ventricular outflow tract calcification affects procedural outcome; therefore, careful patient selection is crucial.

Endovascular reconstruction of the aortic bifurcation in patients with Leriche syndrome.

BACKGROUND: The Leriche syndrome with contiguous total occlusions of the infrarenal aorta and the iliac arteries is a variant of Trans-Atlantic Inter-Society Consensus (TASC) type D aortoiliac disease, for which surgery is the recommended treatment of choice. We sought to prospectively assess the feasibility and safety of an endovascular therapeutic approach. METHODS: Eleven consecutive patients with Leriche syndrome (eight men; 64 +/- 12 years) constituted the study cohort. The treatment strategy consisted of recanalization by transbrachial access of the occluded segments and subsequent transfemoral angioplasty with selective stent placement in the distal aorta and primary nitinol stent placement in the iliac arteries. RESULTS: Bilateral endovascular success was achieved in eight patients (73%), unilateral success in the other three patients. Seven patients received aortic stents; the total stented segment length in 19 iliac arteries successfully recanalized amounted to a median of 18 cm (range 12-26 cm). There was one periprocedural complication, an acute thrombotic aortoiliac occlusion managed by thrombolysis. One patient with unilateral endovascular success had to undergo femorofemoral crossover bypass grafting. At a median of 14 months, significant hemodynamic improvement was observed in successfully revascularized legs (ankle-brachial index, 0.79 +/- 0.20 vs. 0.48 +/- 0.08 at baseline; P = 0.0004); walking capacity as well as Rutherford category of peripheral arterial disease had improved in all patients. CONCLUSIONS: In this small series of patients with Leriche syndrome, the reconstruction of the totally occluded aortoiliac bifurcation by endoluminal means was shown to be feasible and safe and associated with excellent mid-term clinical outcomes.

Retrograde transarterial implantation of a nonmetallic aortic valve prosthesis in high-surgical-risk patients with severe aortic stenosis: a first-in-man feasibility and safety study.

BACKGROUND: To assess the feasibility and safety of retrograde transarterial implantation of a novel nonmetallic aortic valve prosthesis (Direct Flow Medical Inc, Santa Rosa, Calif), a prospective single-center study was performed in patients with severe aortic stenosis at high risk for open-heart surgery. METHODS AND RESULTS: Fifteen patients (intention-to-treat cohort) with an aortic valve area < or = 0.8 cm(2), a > or = 35-mm Hg mean transvalvular pressure gradient, and a logistic EuroSCORE > or = 20% were enrolled. Percutaneous aortic valve replacement was performed with the patient under general anesthesia. Hemodynamic parameters were assessed before and after implantation by transesophageal echocardiography. Clinical follow-up and transthoracic echocardiographic assessment were obtained at 30 days. Procedural success was achieved in 12 patients (80%). Surgical conversion became necessary at day 2 in 1 patient; 11 patients (73%) were discharged with a permanent implant. In these patients, implantation resulted acutely in a significant increase in aortic valve area (median, 1.64 [interquartile range, 1.27 to 1.74] versus 0.60 [0.46 to 0.69] cm(2); P = 0.0033) and a concomitant reduction in the mean pressure gradient (14.0 [13.2 to 16.5] versus 54.0 [43.2 to 59.8] mm Hg; P = 0.0033). At 30 days, 1 cardiac death (6.7%; 95% CI, 0.2% to 32.0%) and 1 major stroke were observed. The 10 surviving patients with a permanent implant showed marked hemodynamic and clinical improvement at this time point. CONCLUSIONS: In this small series of patients, percutaneous implantation of the Direct Flow Medical aortic valve prosthesis in high-surgical-risk patients was feasible and associated with a reasonably low safety profile.

Metalloproteinases-2, -9 and TIMP-1 expression in stable and unstable coronary plaques undergoing PCI.

INTRODUCTION: Experimental models and ex-vivo studies suggest a crucial role of some matrix metalloproteinases (MMPs) in the development of acute coronary syndromes, but expression levels of MMP-2, MMP-9 and TIMP-1 in human coronary plaques causing stable angina or an acute coronary syndrome have not been reported, yet. METHODS: MMP-2, -9 and TIMP-1 expressions were assessed by real-time PCR from the debris collected into distal protective vascular guards from patients with stable angina (SA-Group, n=16), acute coronary syndrome (ACS-Group, n=16) undergoing percutaneous coronary interventions (PCI). MMP-2 and -9 activities were also evaluated by gelatin-substrate zymography on plasma samples collected immediately before PCI, and compared to those of healthy subjects (Control-Group). RESULTS: The expression of MMP-2 was similar in ACS and SA-Groups. MMP-9 (P=0.011), but not TIMP-1, expression was higher in debris samples from patients in the ACS-Group than in SA-Group. In both groups, the expression of MMP-2 and MMP-9 were inversely correlated (rho=-0.7; P<0.004). Zymography data indicated that pro and active MMP-9 were higher in ACS than in SA-Group, while no difference in MMP-2 was found. CONCLUSIONS: MMP-9, but not TIMP-1 or MMP-2 expression is increased in plaques causing acute coronary syndrome.

Long-term outcome of patients with atrioventricular node reentrant tachycardia.

BACKGROUND: Little information is available on the natural history of patients with AVNRT. The purpose of this study was to compare the outcome of patients with Atrioventricular node reentrant tachycardia (AVNRT) who underwent ablation with those on antiarrhythmic therapy and those not receiving drugs. METHODS: 93 consecutive patients (mean age=33.5+/-18.1 years) with AVNRT referred to our institution from 1988 to 1993 were prospectively followed-up for a mean of 13.2+/-2.0 years (range=11.4-16.1 years). RESULTS: 18 patients underwent ablation (group 1), 24 received antiarrhythmic therapy (group 2), 38 received no drugs or remained on drug therapy for only few months (group 3), 3 died and 10 were lost to follow-up. The frequency of symptoms at the baseline was higher in group 1 than in groups 2 and 3 (7.8+/-3.7, 3.5+/-2.3, 2.3+/-1.9 episodes/month, respectively; p<0.02 in group 1 vs. group 3). At the end of the follow-up 18/18 (100%) of group 1, 14/23 (61%) of group 2 and 17/38 of group 3 (44.7%) reported being asymptomatic for the previous 3 years. Group 3 patients who became asymptomatic had a shorter duration of symptoms before enrolment (3.7+/-1.5 vs. 7.1+/-3.6 years, p<0.05) and a shorter mean length of the tachycardia episodes (3.8+/-2.4 vs. 42.6+/-17.8 min, p<0.02) than patients from the same group who remained symptomatic. CONCLUSIONS: The main result of this study is that during a long-term follow-up a considerable number of untreated patients with AVNRT become asymptomatic. This finding should be considered for choosing treatment modality and for calculating healthcare costs of ablation vs. medical therapy.

Effects of various promoter derived sequences on the cleavage kinetic of an hammerhead ribozyme directed against cyclin E1 mRNA.

Hammerhead ribozymes (HRz), catalytic RNA molecules capable of inducing the site-specific cleavage of a phosphodiester bond within an RNA molecule, are typically introduced into target cells by specific constructs (such as viral vectors) able to drive their expression from defined expression cassettes (promoter). This strategy implies the presence of promoter-derived sequences bound to the hammerhead ribozyme structure, a fact which can unpredictably affect HRz cleavage efficiency and eventually the biological effect. We explored the effects of promoter-derived sequences on the cleavage kinetics of an HRz targeted against a relevant cell cycle regulator, i.e. cyclin E1, implicated in the pathogenesis of several human diseases including in-stent restenosis and hepatocellular carcinoma. Sequences derived form the most commonly used promoters (CMV, T7, Pol I and Pol III promoters) were added to the minimal HRz structure and their effects on the cleavage kinetic constants k(cat) and K(m) evaluated in vitro under single turn-over conditions, using a mathematical model we recently developed. The different promoter derived sequences variably affected HRz cleavage efficiency (k(cat)/K(m)) with those derived from the pol III and from a truncated form of T7 promoter (T7-S), impairing maximally and minimally k(cat)/K(m), respectively. Additionally, the extra sequences tend to increase K(m) and to reduce k(cat). The extent of this effect depends both on the secondary RNA structure and on the length of the added sequences. In conclusion, these data, together with further work in cultured cells, can lead to the selection of optimal expression cassettes thus contributing to improve HRz efficacy, bringing these molecules closer to practical applications.

Use of the ejection fraction-velocity ratio in the hemodynamic assessment of aortic bioprosthetic valves.

BACKGROUND: A new echocardiographic severity index of aortic valve stenosis has been recently introduced: the ejection fraction-velocity ratio (EFVR), which is a simple ratio ejection fraction/4Vmax2. This nonflow corrected index demonstrated an excellent accuracy in quantifying the effective orifice area (EOA) in native aortic valves. There is no information about the reliability of EFVR in assessing aortic EOA in patients with bioprostheses. METHODS: In 141 consecutive patients with aortic bioprostheses (85 males, mean age 74 +/- 9 years), EOA was calculated by both continuity equation (CE) and EFVR. RESULTS: The correlation between CE and EFVR was highly significant (r = 0.88; P < 0.0001). The area under the receiver operating characteristic (ROC) curve was 0.97 (considering a positive case CE < 1.0 cm2, best cutoff of EFVR was <1.06). Using CE as gold standard and a cutoff of 1.0 for both indexes, EFVR showed good sensitivity (80%) and specificity (98%). Also in a subgroup of 46 patients with moderate or severe mitral regurgitation, the EFVR had a good diagnostic accuracy (sensitivity 89%, specificity 97%). In 91 patients with ejection fraction < or = 50%, the EFVR confirmed good sensitivity (79%) and specificity (97%). CONCLUSIONS: The EFVR, a simple and not time-consuming index, demonstrated a good diagnostic accuracy in assessing EOA also in patients with aortic bioprostheses. The presence of moderate to severe mitral regurgitation or left ventricular dysfunction does not reduce significantly the reliability of this new index. The EFVR can be taken into consideration in the clinical practice, at least when CE measurements are technically difficult.