Comparison of Two Different Techniques for Isolated Left Subclavian Artery Revascularization During Thoracic Endovascular Aortic Repair in Zone 2.

PURPOSE: To analyze the results of isolated left subclavian artery (LSA) revascularization during thoracic endovascular aortic repair (TEVAR) using carotid-subclavian bypass (CSbp) or chimney grafts (CGs). METHODS: A retrospective multicenter, observational study identified 73 patients (mean age 68±13 years, range 22-87; 56 men) with acute or chronic thoracic aortic lesions who underwent TEVAR with isolated LSA revascularization using either CSbp (n=42) or CGs (n=31) from January 2010 and February 2017. Primary endpoints were TEVAR-related mortality, postoperative stroke, freedom from type Ia endoleak, and LSA patency. RESULTS: Primary technical success was achieved in all cases. Early TEVAR-related mortality was 4.2% (CSbp 2% vs CG 6%, p=0.571). Two (3%) patients had major ischemic strokes (one in each group). Mean follow-up was 24±21 months (range 1-72; median 15). Estimated freedom from TEVAR-related mortality was 93%±3% (95% CI 84.3% to 97.0%) at 12 and 36 months, with no significant difference between CSbp and CG (p=0.258). Aortic reintervention did not differ between the groups (CSbp 5% vs CG 6%, p=0.356); nor did freedom from type Ia endoleak (CSbp 98% vs CG 87%, p=0.134). Gutter-related endoleaks occurred in 4 (13%) CG patients, but none of the patients experienced sac enlargement or the need for reintervention and none died. Primary patency of the LSA was 100% for the entire group during the observation period. CONCLUSION: In our experience, LSA revascularization proved most satisfactory and equally effective with both the CSbp and CG techniques, without discernible differences at midterm follow-up.

Radial versus femoral access in patients with acute coronary syndromes undergoing invasive management: a randomised multicentre trial.

BACKGROUND: It is unclear whether radial compared with femoral access improves outcomes in unselected patients with acute coronary syndromes undergoing invasive management. METHODS: We did a randomised, multicentre, superiority trial comparing transradial against transfemoral access in patients with acute coronary syndrome with or without ST-segment elevation myocardial infarction who were about to undergo coronary angiography and percutaneous coronary intervention. Patients were randomly allocated (1:1) to radial or femoral access with a web-based system. The randomisation sequence was computer generated, blocked, and stratified by use of ticagrelor or prasugrel, type of acute coronary syndrome (ST-segment elevation myocardial infarction, troponin positive or negative, non-ST-segment elevation acute coronary syndrome), and anticipated use of immediate percutaneous coronary intervention. Outcome assessors were masked to treatment allocation. The 30-day coprimary outcomes were major adverse cardiovascular events, defined as death, myocardial infarction, or stroke, and net adverse clinical events, defined as major adverse cardiovascular events or Bleeding Academic Research Consortium (BARC) major bleeding unrelated to coronary artery bypass graft surgery. The analysis was by intention to treat. The two-sided α was prespecified at 0·025. The trial is registered at ClinicalTrials.gov, number NCT01433627. FINDINGS: We randomly assigned 8404 patients with acute coronary syndrome, with or without ST-segment elevation, to radial (4197) or femoral (4207) access for coronary angiography and percutaneous coronary intervention. 369 (8·8%) patients with radial access had major adverse cardiovascular events, compared with 429 (10·3%) patients with femoral access (rate ratio [RR] 0·85, 95% CI 0·74-0·99; p=0·0307), non-significant at α of 0·025. 410 (9·8%) patients with radial access had net adverse clinical events compared with 486 (11·7%) patients with femoral access (0·83, 95% CI 0·73-0·96; p=0·0092). The difference was driven by BARC major bleeding unrelated to coronary artery bypass graft surgery (1·6% vs 2·3%, RR 0·67, 95% CI 0·49-0·92; p=0·013) and all-cause mortality (1·6% vs 2·2%, RR 0·72, 95% CI 0·53-0·99; p=0·045). INTERPRETATION: In patients with acute coronary syndrome undergoing invasive management, radial as compared with femoral access reduces net adverse clinical events, through a reduction in major bleeding and all-cause mortality. FUNDING: The Medicines Company and Terumo.

Ultrasound-Assisted, Catheter-Directed Thrombolysis for Acute Intermediate/High-Risk Pulmonary Embolism: Design of the Multicenter USAT IH-PE Registry and Preliminary Results.

Catheter-based revascularization procedures were developed as an alternative to systemic thrombolysis for patients with intermediate-high- and high-risk pulmonary embolisms. USAT IH-PE is a retrospective and prospective multicenter registry of such patients treated with ultrasound-facilitated, catheter-directed thrombolysis, whose preliminary results are presented in this study. The primary endpoint was the incidence of pulmonary hypertension (PH) at follow-up. Secondary endpoints were short- and mid-term changes in the echocardiographic parameters of right ventricle (RV) function, in-hospital and all-cause mortality, and procedure-related bleeding events. Between March 2018 and July 2023, 102 patients were included. The majority were at intermediate-high-risk PE (86%), were mostly female (57%), and had a mean age of 63.7 ± 14.5 years, and 28.4% had active cancer. Echocardiographic follow-up was available for 70 patients, and in only one, the diagnosis of PH was confirmed by right heart catheterization, resulting in an incidence of 1.43% (CI 95%, 0.036-7.7). RV echocardiographic parameters improved both at 24 h and at follow-up. In-hospital mortality was 3.9% (CI 95%, 1.08-9.74), while all-cause mortality was 11% (CI 95%, 5.4-19.2). Only 12% had bleeding complications, of whom 4.9% were BARC ≥ 3. Preliminary results from the USAT IH-PE registry showed a low incidence of PH, improvement in RV function, and a safe profile.

Symptoms-to-emergency-call timing delay in acute coronary syndrome before and during COVID-19: independent predictors and their impact on mortality.

BACKGROUND: The COVID-19 pandemic severely impacted global health. The aim of this study was to compare predictors of symptoms-to-emergency-call timing delay in acute coronary syndrome (ACS) and their impact on mortality before and during the COVID-19 outbreak. METHODS: We collected sociodemographic, clinical data, procedural features, preadmission and intra-hospital outcomes of consecutive patients admitted for ACS in seventeen Italian centers from March to April 2018, 2019, and 2020. RESULTS: In 2020, a 32.92% reduction in ACS admissions was observed compared to 2018 and 2019. Unstable angina, typical and atypical symptoms, and intermittent angina were identified as significant predictors of symptoms-to-emergency-call timing delay before and during the COVID-19 pandemic (P<0.005 for all the items). Differently from 2018-2019, during the pandemic, hypertension and dyspnea (P=0.002 versus P=0.490 and P=0.001 vs. P=0.761 for 2018-2019 and 2020, respectively) did not result as predictors of delay in symptoms-to-emergency-call timing. Among these predictors, only the atypical symptoms (HR 3.36; 95% CI: 1.172-9.667, P=0.024) in 2020 and the dyspnea (HR 2.64; 95% CI: 1.345-5.190, P=0.005) in 2018-2019 resulted significantly associated with higher mortality. Finally, the family attendance at the onset of the symptoms resulted in a reduction in symptoms-to-emergency-call timing (in 2020 P<0.001; CI: -1710.73; -493.19) and in a trend of reduced mortality (HR 0.31; 95% CI: 0.089-1.079, P=0.066) in 2020. CONCLUSIONS: During the COVID-19 outbreak, atypical symptoms and family attendance at ACS onset were identified, respectively, as adverse and favorable predictors of symptoms-to-emergency-call timing delay and mortality.

The Incidence and Impact of In-Hospital Bleeding in Patients with Acute Coronary Syndrome during the COVID-19 Pandemic.

BACKGROUND: The COVID-19 pandemic increased the complexity of the clinical management and pharmacological treatment of patients presenting with an Acute Coronary Syndrome (ACS). AIM: to explore the incidence and prognostic impact of in-hospital bleeding in patients presenting with ACS before and during the COVID-19 pandemic. METHODS: We evaluated in-hospital Thrombolysis In Myocardial Infarction (TIMI) major and minor bleeding among 2851 patients with ACS from 17 Italian centers during the first wave of the COVID-19 pandemic (i.e., March-April 2020) and in the same period in the previous two years. RESULTS: The incidence of in-hospital TIMI major and minor bleeding was similar before and during the COVID-19 pandemic. TIMI major or minor bleeding was associated with a significant threefold increase in all-cause mortality, with a similar prognostic impact before and during the COVID-19 pandemic. CONCLUSIONS: the incidence and clinical impact of in-hospital bleeding in ACS patients was similar before and during the COVID-19 pandemic. We confirmed a significant and sizable negative prognostic impact of in-hospital bleeding in ACS patients.

Comparison of sirolimus-eluting and bare metal stent for treatment of patients with total coronary occlusions: results of the GISSOC II-GISE multicentre randomized trial.

AIMS: Percutaneous coronary intervention with bare metal stent (BMS) in chronic total coronary occlusions (CTOs) is associated with a higher rate of angiographic restenosis and reocclusion than that observed in subtotal stenoses. Preliminary reports have suggested a better performance of drug-eluting stents in CTO. In this multicentre, randomized trial, we compared the mid-term angiographic and clinical outcome of sirolimus-eluting stent (SES) or BMS implantation after successful recanalization of CTO. METHODS AND RESULTS: Patients with CTO older than 1 month, after successful recanalization, were randomized to implantation of SES (78 patients) or BMS (74 patients) in 13 Italian centres. Clopidogrel therapy was prescribed for 6 months. The primary endpoint was in-segment minimal luminal diameter (MLD) at 8-month follow-up. Secondary clinical endpoints included death, myocardial infarction (MI), target lesion revascularization (TLR), and target vessel revascularization (TVR) at 24 months. Patients treated with SES showed, at in-segment analysis, a larger MLD (1.98 +/- 0.57 vs. 0.98 +/- 0.80 mm, P < 0.001), a lower late luminal loss (-0.06 +/- 0.49 vs. 1.11 +/- 0.79 mm, P < 0.001), and lower restenosis (9.8 vs. 67.7%, P < 0.001) and reocclusion (0 vs. 17%, P = 0.001) rates. At 24-month follow-up, patients in the SES group experienced fewer major adverse cardiac events (50.0 vs. 17.6%, P < 0.001) mainly due to a lower rate of both TLR (44.9 vs. 8.1%, P < 0.001) and TVR (44.9 vs. 14.9%, P < 0.001). CONCLUSION: In CTO, SES is markedly superior to BMS in terms of restenosis and reocclusion rate, and incidence of repeat revascularization at 24 months. Clinicaltrials.gov identifier: NCT00220558.

Evaluation of different internal-diameter column combinations in comprehensive two-dimensional gas chromatography in flavour and fragrance analysis.

A series of OV1-OV1701 column sets, in which the two dimensions differ in id and/or film thickness, were adopted to separate components of the volatile and semivolatile fraction of samples of plant origin. In particular two applications are presented: a target analysis approach to determine volatile suspected allergens in a medium-complexity fragrance and in sandalwood essential oil, and a fingerprint analysis approach to compare herbal extracts. Some basic chromatographic parameters of these combinations, i. e. net separation measure (S(GC x GC)), degree of orthogonality and a suitable number of modulations per peak, were also estimated by analysing two test mixtures: FAME (C4:0-C24:0) and suspected volatile allergens. Experimental results show that 0.25 mm homologous id column combination, despite their lower separation power, have good capacity to separate and resolve medium-to-complex fractions from samples of plant origin, demonstrating: (i) good system orthogonality, maximized through proper exploitation of stationary-phase selectivity and (ii) reduced 2-D column overloading effects due to the increased 2-D mass loadability, thus facilitating the analysis of mixtures whose components differ significantly in relative abundance.

[Percutaneous treatment of coronary artery fistula: a tailored strategy is needed]. / Trattamento percutaneo di fistola coronarica: serve una strategia su misura.

Coronary artery fistula (CAF) is a rare, abnormal connection between one or more coronary arteries and a cardiac chamber, or great vessel.We describe the case of a male patient with worsening effort angina referred for coronary angiography. The examination revealed the presence of a CAF between the proximal left anterior descending (LAD) and pulmonary arteries, with mid LAD subocclusive stenosis. Ad hoc PCI with stenting was performed in the mid LAD, followed by CAF embolization with coils and plugs. Angiography and computed tomography scan at follow-up showed complete CAF occlusion, stent patency, and normal flow reserve of the LAD. CAF treatment is indicated only for large or clinically significant symptomatic fistulas. Treatment strategy, technique and device choice should be tailored on CAF anatomical characteristics. In this case, our strategy was feasible, safe and successful with favorable long-term results.

Comprehensive two-dimensional gas chromatography in the analysis of volatile samples of natural origin: a multidisciplinary approach to evaluate the influence of second dimension column coated with mixed stationary phases on system orthogonality.

The study evaluates the influence of selectivity tuning of the stationary phase of the second dimension on the orthogonality of a comprehensive two-dimensional gas chromatography (GC x GC) system. Two different sets of columns, providing independent and semi-independent separation mechanisms were used. The first consisted of a first dimension separating analytes on a volatility basis (i.e. a non-polar polydimethylsiloxane (OV1) column) combined with a second dimension separating by polarity, using columns coated with 100% polyethylene glycol (CW20M), CW20M/OV1 mixtures in ratios of 25-75%, and polydimethylsiloxane, 7% phenyl, 7% cyanopropyl (OV1701). The second set consisted of a first dimension separating analytes on a polarity basis (100% CW20M column) combined with a second dimension separating by volatility, consisting of columns coated with 100% OV1, OV1/CW20M mixtures in ratios of 25-75%, and 100% OV1701. Medium-complexity mixtures of natural origin (i.e. peppermint essential oil and a standard mixture of suspected allergens) consisting of components in a relatively limited range of molecular weights (MW) and volatilities, but belonging to different classes of compounds in a wide range of polarity (mono- and sesquiterpenoids, hydrocarbons and oxygenated compounds) were analysed with the above sets of columns. Different approaches were used to evaluate peak spreading on the GC x GC separation plane and degree of orthogonality of the column sets, namely: (1) a Factor Analysis (FA) approach, estimating the correlation coefficients and spreading angles of the sample components in the two-dimensional chromatographic plane; (2) an Informational Theory (IT) approach, based on determining a group of parameters including: informational entropy, % synentropy and similarity (H); and (3) an approach based on estimating the amount of separation space used, i.e. a practical parameter that directly refers to the experimental separation plane of the GC x GC chromatogram. Results showed that peak spreading in the chromatographic plane, when CW20M and OV1 are combined in different ratios, can be predicted from retention mechanisms, and that the degree of orthogonality measured with different approaches, is consistent with the divergent nature, in terms of polarity of the stationary phases combined in the GC x GC system.

[Percutaneous treatment of pulmonary embolism: diffusion and use of the technique in Italian interventional cardiology centers. Results of the PETER survey]. / Trattamento percutaneo dell'embolia polmonare: diffusione e utilizzo della metodica in centri cardiologici interventistici italiani. Risultati dell'indagine conoscitiva PETER.

BACKGROUND: Reperfusion in acute pulmonary embolism (PE) by percutaneous techniques is a valid therapeutic option when there is a formal contraindication to or failure of thrombolysis. In the last years, an increasing number of patients with acute PE have been treated with these techniques. METHODS: In order to obtain a map of current availability and use of percutaneous techniques in PE, on behalf of the ANMCO Pulmonary Circulation Area, 56 Italian interventional cardiology and radiology departments, equipped with technology for percutaneous embolectomy, were invited to participate in a national survey. Questionnaires were e-mailed to each department from April to May 2015. RESULTS: Thirty-one out of 56 centers (54.8% in the North, 9.7% in the Center and 35.5% in the South of Italy) answered to the questionnaire. Percutaneous techniques were available in 90% of the cardiology departments involved, reporting also a good experience with their use in PE (77.4%). Only two responders were interventional radiology departments. AngioJet(®) and EkoSonic Endovascular System(®) (64.7% and 19.4%, respectively) were the most common devices used. Overall, in 2014, 62 patients were treated with percutaneous techniques, mainly in the North of the country. With regard to local diagnostic and therapeutic protocols, 61.3% of respondents reported owning one. Great interest was provided by participants in adhering to this national multicenter registry. CONCLUSIONS: Our results show the interest of Italian cardiology departments about percutaneous techniques as a therapeutic option for acute PE. Percutaneous techniques are largely available but still underused in routine clinical practice.

Endograft repair for pseudoaneurysms and penetrating ulcers of the ascending aorta.

OBJECTIVE: The aim of this paper is to report midterm results of thoracic endovascular aortic repair (TEVAR) for ascending aortic pseudoaneurysms (AAPs) and penetrating aortic ulcers (PAUs) of the ascending aorta. METHODS: This study was retrospective and performed at tertiary centers. Eight patients with AAPs (n = 5) and PAUs (n = 3) received total endovascular repair of the ascending aorta. Patients with a history of type A aortic dissection or fusiform aneurysm were excluded. All patients analyzed were considered to be at high risk for open repair at the time of presentation. RESULTS: Urgent intervention was performed in 6 (75%) cases. Primary clinical success was achieved in 7 (87.5%) cases. A low-flow type 3 endoleak remained asymptomatic and was managed conservatively. No TEVAR-related in-hospital mortality, primary conversion, cerebrovascular accidents, valve impairment, or myocardial infarction occurred. All patients were discharged home, alive and independent, after a median length of stay of 6 (range: 5-24) days. No patient was lost at a mean follow-up of 40 ± 33 (range: 4-93) months. Ongoing primary clinical success was maintained in all but 1 patient (type 3 endoleak): aortically related reintervention was never required. No endograft breakage or migration was observed. At 1-year follow-up, 7 (87.5%) aortic lesions had significant reduction in diameter (≥5 mm). CONCLUSIONS: Ascending TEVAR was feasible, safe, and effective for AAPs and PAUs. In a very select subset of lesions, midterm results were favorable, with both standard and custom-designed endografts.

Management and Long-Term Prognosis of Spontaneous Coronary Artery Dissection.

The optimal management and short- and long-term prognoses of spontaneous coronary artery dissection (SCAD) remain not well defined. The aim of this observational multicenter study was to assess long-term clinical outcomes in patients with SCAD. In-hospital and long-term outcomes were assessed in 134 patients with documented SCAD, as well as the clinical impact and predictors of a conservative rather than a revascularization strategy of treatment. The mean age was 52 ± 11, years and 81% of patients were female. SCAD presented as an acute coronary syndromes in 93% of patients. A conservative strategy was performed in 58% of patients and revascularization in 42%. On multivariate analysis, distal versus proximal or mid location of dissection (odds ratio 9.27) and basal Thrombolysis In Myocardial Infarction (TIMI) flow grade 2 or 3 versus 0 or 1 (odds ratio 0.20) were independent predictors of conservative versus revascularization strategy. A conservative strategy was associated with better in-hospital outcomes compared with revascularization (rates of major adverse cardiac events 3.8% and 16.1%, respectively, p = 0.028); however, no significant differences were observed in the long-term outcomes. In conclusion, in this large observational study of patients with SCAD, angiographic features significantly influenced the treatment strategy, providing an excellent short- and long-term prognosis.

Stent implantation in very small coronary arteries: the Tsunami SV International Registry.

The aim of this multicenter registry was to examine the in-hospital and long-term clinical outcomes of patients who underwent Tsunami SV stent implantation for the treatment of lesions involving coronary arteries with a reference diameter of <2.5 mm. The angiographic success rate was 97.5%. No in-hospital or 30-day major adverse cardiac events occurred. During the 6-month follow-up, there was 1 cardiac death (1%), and 5 subjects (4.8%) underwent repeat target lesion revascularization.

Direct resistively heated column gas chromatography (Ultrafast module-GC) for high-speed analysis of essential oils of differing complexities.

This study applies Ultrafast module-GC (UFM-GC) with direct resistively heated columns to routine analysis of a group of essential oils of differing complexities (chamomile, peppermint, rosemary and sage). Essential oils were analysed by conventional GC with conventional inner diameter (i.d.) columns (0.25 mm) of different lengths (5 and 25 m long) and by Fast GC and Ultrafast module-GC with narrow bore columns (0.1 mm i.d., 5 m long). Column performance were evaluated and compared through their Grob test, separation number and peak capacity. Ultrafast module-GC was successful in the qualitative and quantitative analysis of essential oils of different compositions with analysis times between 40 s and 2 min versus 20-60 min required by conventional GC. Critical pairs or groups of components were separated by carefully tuning selectivity of the stationary phase to compensate for loss of efficiency due to the use of short columns and high temperature rates. The Ultrafast module-GC results of peppermint e.o. analyses were also validated and compared to those obtained by conventional GC; by measuring precision over time (i.e. repeatability and intermediate precision) and accuracy. Ultrafast module-GC showed a good separation reproducibility affording reliable component identification through the relative retention times and quantitative determination through normalised peak areas. Accuracy data also showed that Ultrafast module-GC and conventional GC normalised areas and areas percentage were perfectly comparable.

Ad hoc transradial coronary angioplasty strategy: experience and results in a single centre.

BACKGROUND: The combination of diagnostic and angioplasty as a single procedure is becoming common practice in many institutions, but the feasibility of this strategy performed with the transradial approach in a large group of patients has not been evaluated. This study was performed to explore the feasibility, safety and cost-effectiveness of the transradial approach as a single procedure for diagnostic angiography and angioplasty, including stent implantation. METHODS: From February 1999 and November 2000 the percutaneous transradial approach was attempted in 800 patients with functional radial arch attested using Allen's test. Interventional procedures, PTCA and stent implantation, when indicated and appropriated, have been performed as a single procedure. RESULTS: Out of 800 patients submitted to coronarography, 390 were treated with PTCA and or stent implantation as single procedure. In this group of patients, 425 lesions (1.2 lesions/patient) were treated. A PTCA was performed in 98 (23.5%) lesions and PTCA plus stent implantation were performed in 327 (76.5%) lesions. Procedural success was achieved in 419/425 lesions (98.5%) in the radial group and in 98% in the staged group. The mean time to place the sheath was longer in the transradial group (P<0.01), but the time required to obtain hemostasis was markedly shorter in the transradial patients (P<0.01); no differences in fluoroscopy time, contrast volume and catheters per case was found. Access site bleeding complications were significantly reduced in the radial group (P<0.01) and total hospital length of stay was lesser in the radial group (mean days 1.9) as compared to femoral group (mean days 2.9) with a reduction of total hospital charge. The reduction of costs for 100 patients was Euro 78,000. CONCLUSION: Our results show that a combined strategy of angiography and angioplasty via the radial artery is feasible, safe, more comfortable for the patient, and more cost-effective than a staged procedure. This approach might be ideal for outpatient or ad hoc invasive coronary procedures.

Transradial approach for renal percutaneous transluminal angioplasty and stenting: a feasibility pilot study.

BACKGROUND: Stent implantation of renal stenosis (RS) has been reported on extensively; this technique is perceived as superior to balloon angioplasty alone and less invasive than surgical revascularization. With the development of new accessories and stents, we can now improve and optimize procedural and clinical results. In this pilot study, we tested an alternative minimally invasive approach for renal stenting: the transradial artery catheterization (TAC) and a 6 French (Fr) system for stenting. METHODS: In this feasibility study, we enrolled patients with RS uncontrolled hypertension and/or chronic renal insufficiency. After assuring good dual blood supply (Allen test), TAC was attempted. The guiding catheters chosen for stenting were 6 Fr (0.70 ) Zuma 2 (Medtronic AVE, Santa Rosa, California). The selection of the guiding catheter was performed with respect to back-up support and coaxial alignment. RS were crossed with a coronary extra support guidewire (0.0.14 mailman, Boston Scientific/Scimed, Maple Grove, Minnesota). A balloon angioplasty before stenting was performed only in presence of subocclusive calcified stenosis, otherwise direct stenting was performed. We used low profile stents (12 16 mm LP Sulzer stent, IntraTherapeutics Inc., Minnesota) manually crimped on monorail balloon (5.0 6.0 mm x 20 mm). Immediately after completion of the procedure, the sheath was removed and a selective radial artery compression device was used for hemostasis. Patients were not restricted to bedrest, but were discharged the following day. RESULTS: There were 25 patients in the study population. Procedural indications were poorly controlled hypertension in 15/25 patients and/or preservation of renal function in 10/25 patients. Procedural success was obtained in 27/27 lesions (100%). Direct stenting was performed in 24/27 stenosis; predilatation was necessary in 3/27. We used 1 stent per lesion. The mean fluoro time was 7 5 minutes/lesion and mean procedural time was 14 5 minutes/lesion. No procedural and clinical complications occurred during the procedures upon the discharge. CONCLUSIONS: Our results confirmed the safety of this approach in the treatment of RS. The devices used in the study were those traditionally used for coronary procedures. The adoption of these materials and techniques have simplified the procedure and has permitted a reduction of fluoro and procedural time. An additional advantage has been the passive achievement of hemostasis by pressure devices reducing the workload of nursing and medical staff with elimination of bleeding complications that allowed immediate post procedural ambulation.

[Primary angioplasty in acute myocardial infarction: experience and results in the first 1,000 consecutive patients]. / Angioplastica primaria nell'infarto micocardico acuto: esperienza e risultati nei primi 1000 pazienti consecutivi.

BACKGROUND: One of the biggest debates in modern cardiology regards the relative merit of primary percutaneous transluminal coronary angioplasty (PTCA) versus thrombolysis for the treatment of acute myocardial infarction with persistent ST-segment elevation. After the excellent results with primary PTCA in trials and meta-analyses, the next question is whether such results might be duplicated in "real world" conditions. METHODS: Between January 1995 and April 2003, 1000 consecutive patients with acute myocardial infarction, out of 2272 (44%) with ST-segment elevation admitted to the coronary care unit at the Cardiology Department of the S. Anna Hospital, were treated with PTCA. Our Institution is a medium-high volume center, without on-site surgery. Usual clinical and interventional practice, adjunctive antithrombotic therapy and results are described in this paper. RESULTS: Primary PTCA has been performed in 825 patients (75%) out of 1095 undergoing emergency angiography, "facilitated" in 140 (13%), rescue in 35 (3.2%). Eighty patients of the "facilitated" PTCA group had been pre-treated with tissue-type plasminogen activator 50 mg i.v. bolus, 50 with abciximab and 10 with reduced doses of fibrinolytic and abciximab. One hundred and seventy patients (16%) had been transferred to our Institution from community hospitals. Nine patients out of 1000 undergoing PTCA (0.9%) have been transferred immediately after the procedure (bail-out, failure) to perform urgent coronary artery bypass grafting. PTCA has been completed by stenting in 919 patients (92%). The median door-to-balloon time was 58 min (25th-75th percentile 49-71). The in-hospital total mortality rate was 4.9% (49 deaths): 5.3% (44 deaths) in the primary PTCA group, 2.1% (3 deaths) in the "facilitated" PTCA group (p = 0.042), and 5.7% (2 deaths) in the rescue PT-CA group. Early reinfarction rate was 1.5% (15 cases). The median time to hospital discharge was 10 days (25th-75th percentile 7-14). CONCLUSIONS: Since 9 years, our practice in the treatment of acute myocardial infarction with persistent ST-segment elevation is going on extending the use of primary PTCA, integrating pharmacological and mechanical options in selected cases.

Scientific foundation and possible implications for practice of the Minimizing Adverse Haemorrhagic Events by Transradial Access Site andSystemic Implementation of AngioX (MATRIX) trial.

Early invasive management and the use of combined antithrombotic therapies have decreased the risk of recurrent ischaemia in patients with acute coronary syndrome (ACS) but have also increased the bleeding risk. Transradial intervention (TRI) and bivalirudin infusion compared to transfemoral intervention (TFI) or unfractionated heparin (UFH) plus glycoprotein IIb/IIIa inhibitors (GPI) decrease bleeding complications in patients with ACS. To what extent, a bleeding preventive strategy incorporating at least one of these two treatment options translates into improved outcomes is a matter of debate. The Minimizing Adverse Haemorrhagic Events by Transradial Access Site and Systemic Implementation of AngioX study is a large-scale, multicenter, prospective, open-label trial, conducted at approximately 100 sites in Europe aiming to primarily assess whether TRI and bivalirudin infusion, as compared to TFI and UFH plus provisional GPI, decrease the 30-day incidence of death, myocardial infarction or stroke across the whole spectrum of ACS patients.

Clinical outcome of patients with de novo coronary bifurcation lesions treated with the Tryton Side Branch Stent. The SAFE-TRY prospective multicenter single arm study.

BACKGROUND: Coronary bifurcation lesions represent a difficult problem regularly confronting interventional cardiologist, in part due to the lack of dedicated device. OBJECTIVE: To investigate the feasibility, safety and effectiveness of the Tryton Side Branch Stent (Tryton Medical, Durham, NC, USA), a dedicated bare metal stent deployed in conjunction with a standard drug-eluting stent to treat bifurcation lesions. METHODS: The SAFE-TRY is a prospective single arm multicenter registry including patients with de novo bifurcation lesions in native coronary arteries and syntax score <32. The primary endpoint was target vessel failure (TVF) at 30 days that comprised cardiac death, target vessel myocardial infarction and clinically driven target vessel revascularization. Secondary endpoints included device, angiographic and procedural success, 9-month major adverse cardiac and cerebrovascular event (MACCE), and stent thrombosis (ST) rates (ClinicalTrials.gov identifier: NCT01174433). RESULTS: Among 252 enrolled patients, 24% had diabetes and 35.3% unstable angina. True bifurcation lesions involving both branches occurred in 96.8% of cases with Medina classification 1.1.1 in 62%. The left anterior descending artery and the left main were treated in 70% and 8.3% of the patients, respectively. A 6 Fr guide catheter was used in 61% of the cases. Device, angiographic and procedural success rates were 99.6%, 99.6% and 97.2% respectively. The 30-day TVF was 2.8%; the 9-month MACCE rate was 13.7%, with target lesion revascularization being 4.4%. No definite ST occurred. CONCLUSIONS: This prospective, multicenter study confirmed the feasibility, safety and effectiveness of the Tryton Side Branch Stent to treat patients with de novo complex bifurcation lesions.