Impact of SMART Pass filter in patients with ajmaline-induced Brugada syndrome and subcutaneous implantable cardioverter-defibrillator eligibility failure: results from a prospective multicentre study.

AIMS: Ajmaline challenge can unmask subcutaneous implantable cardioverter-defibrillator (S-ICD) screening failure in patients with Brugada syndrome (BrS) and non-diagnostic baseline electrocardiogram (ECG). The efficacy of the SMART Pass (SP) filter, a high-pass filter designed to reduce cardiac oversensing (while maintaining an appropriate sensing margin), has not yet been assessed in patients with BrS. The aim of this prospective multicentre study was to investigate the effect of the SP filter on dynamic Brugada ECG changes evoked by ajmaline and to assess its value in reducing S-ICD screening failure in patients with drug-induced Brugada ECGs. METHODS AND RESULTS: The S-ICD screening with conventional automated screening tool (AST) was performed during ajmaline challenge in subjects with suspected BrS. The S-ICD recordings were obtained before, during and after ajmaline administration and evaluated by the means of a simulation model that emulates the AST behaviour with and without SP filter. A patient was considered suitable for S-ICD if at least one sensing vector was acceptable in all tested postures. A sensing vector was considered acceptable in the presence of QRS amplitude >0.5 mV, QRS/T-wave ratio >3.5, and sense vector score >100. Of the 126 subjects (mean age: 42 ± 14 years, males: 61%, sensing vectors: 6786), 46 (36%) presented with an ajmaline-induced Brugada type 1 ECG. Up to 30% of subjects and 40% of vectors failed the screening during the appearance of Brugada type 1 ECG evoked by ajmaline. The S-ICD screening failure rate was not significantly reduced in patients with Brugada ECGs when SP filter was enabled (30% vs. 24%). Similarly, there was only a trend in reduction of vector-failure rate attributable to the SP filter (from 40% to 36%). The most frequent reason for screening failure was low QRS amplitude or low QRS/T-wave ratio. None of these patients was implanted with an S-ICD. CONCLUSION: Patients who pass the sensing screening during ajmaline can be considered good candidates for S-ICD implantation, while those who fail might be susceptible to sensing issues. Although there was a trend towards reduction of vector sensing failure rate when SP filter was enabled, the reduction in S-ICD screening failure in patients with Brugada ECGs did not reach statistical significance. CLINICAL TRIAL REGISTRATION: https://clinicaltrials.gov Unique Identifier NCT04504591.

Left atrial diverticula in patients undergoing atrial fibrillation ablation: morphologic analysis and clinical impact.

INTRODUCTION: Left atrial diverticula (LAD) have been reported to be (1) at risk for intracavitary thrombosis and cardiac perforation during ablation and (2) sites of extrapulmonary vein foci. In atrial fibrillation (AF) ablation, their presence might undermine procedure safety and efficacy. This observational study evaluates the morphology and clinical impact of LAD in patients undergoing AF ablation. METHODS AND RESULTS: Consecutive patients undergoing computed tomography scan (Aquilion 64, Toshiba, Otawara, Japan) and AF ablation with imaging integration (CARTO 3 Merge, Biosense Webster, CA, USA) in our center were included. Morphologic analysis was performed by 2 independent radiologists. Ablation was obtained by irrigated radiofrequency energy (Navistar Thermocool or Thermocool SF, Biosense Webster). Out of 212 patients, 58 (27.3%) had LAD; 74.4% of LAD were located in the anterosuperomedial left atrium. In patients with and without LAD, the prevalence of prior cerebrovascular events was similarly low. The rate of major periprocedure complications did not differ significantly: 1.7% versus 2.6% (P = 1) in patients with and without LAD, respectively. However, 1 case of cardiac perforation occurred during ablation in a diverticulum. During follow-up, survival free from arrhythmia recurrences was comparable in the 2 groups. CONCLUSION: LAD are present in about one-fourth of patients undergoing AF ablation and, in general, they have no impact on its safety and efficacy. However, occasionally, radiofrequency energy delivery in a LAD can cause tissue overheating and perforation.

[Periprocedural management of anticoagulation therapy and in-hospital outcomes in patients with warfarin indication undergoing percutaneous coronary intervention. Data from the WAR-STENT registry]. / Gestione periprocedurale della terapia anticoagulante ed esiti intraospedalieri nei pazienti con indicazione a warfarin sottoposti ad angioplastica coronarica. Informazioni dal registro WAR-STENT.

BACKGROUND: In patients with an indication for oral anticoagulation (OAC) with warfarin, the management of OAC peri-procedure of percutaneous coronary intervention (PCI) is still not fully defined. To investigate clinical practice and outcomes associated with continuation vs interruption of OAC, with or without bridging with low-molecular-weight heparin (LMWH), we examined the database of the observational, prospective, multicenter Italian WAR-STENT registry. METHODS: The WAR-STENT registry was conducted in 2008-2010 in 37 Italian centers and included 411 consecutive patients in 157 of whom the peri-procedural international normalized ratio (INR) value was available. In relation to the continuation vs interruption of OAC, patients were divided into group 1 (n = 106) and group 2 (n = 51) respectively, and compared. RESULTS: The basal characteristics of the two groups were similar. The most frequent indication for OAC was atrial fibrillation and for PCI acute coronary syndromes, respectively. The pre-procedural mean value of INR was significantly different in group 1 vs group 2 (2.3 ± 0.4 vs 1.5 ± 0.2; p <0.001), while the use of antithrombotic drugs did not differ, except for LMWH which, albeit limited to only 14% of cases, was used significantly more frequently in group 2 (14% vs 2%; p=0.006). The radial approach was used significantly more often in group 1 vs group 2 (72% vs 45%; p=0.002). The in-hospital incidence of major bleeding complications was similar in groups 1 and 2 (4% vs 8%; p=0.27), as well as the occurrence of major adverse cardio-cerebrovascular events, including cardiovascular death, non-fatal myocardial infarction, re-revascularization of the treated vessel, stent thrombosis, stroke and venous thromboembolism (6% vs 6%; p=0.95). There was a tendency towards a higher incidence of minor access-site bleeding complications in group 1 patients treated by the femoral route. CONCLUSIONS: In unselected patients with an indication for OAC with warfarin and undergoing PCI, the continuation vs interruption of OAC (essentially without LMWH bridging) strategies appears similar in terms of efficacy and safety. In consideration of the superior convenience, peri-procedural continuation of OAC should therefore generally be preferred, with the possible exception of patients in whom the femoral approach is required for the procedure.

Twelve-month outcome of patients with an established indication for oral anticoagulation undergoing coronary artery stenting and stratified by the baseline risk of bleeding: Insights from the Warfarin and Coronary Stenting (War-Stent) Registry.

PURPOSE: To evaluate the outcome of patients with an established indication for oral anticoagulation (OAC) undergoing coronary stent implantation (PCI-S) and stratified by the baseline risk of bleeding. MATERIAL AND METHODS: The database of the prospective, multicentre, observational WAR-STENT registry (ClinicalTrials.gov identifier NCT00722319) was analyzed and patients with atrial fibrillation and CHA2DS2-VASc score ≥2, mechanical heart valve, prior cardiac embolism, intra-cardiac thrombus and recent venous thromboembolism who were treated with either triple (warfarin, aspirin and clopidogrel) or dual (warfarin and clopidogrel) or dual antiplatelet (aspirin and clopidogrel) therapy, identified. Patients were then sorted into two groups at non-low and low risk of bleeding, as defined by an ATRIA score >3 and ≤3 respectively, and compared regarding major adverse cardiac and vascular events (MACVE) and bleeding. RESULTS: At 12-month follow up, MACVE were comparable in the two groups, whereas total, major and minor bleeding, as well as combined MACVE and total bleeding, were significantly more frequent in the non-low bleeding risk group. Upon Cox univariate and multivariable analysis, non-low bleeding risk category confirmed as an independent predictor of major bleeding. The choice of antithrombotic therapy however, appeared not to be influenced by the bleeding risk category at baseline. CONCLUSIONS: In patients with an established indication for OAC undergoing PCI-S, non-low bleeding risk category is the most potent independent predictor of major bleeding. Stratification of the bleeding risk at baseline should therefore be regarded as an indispensable process to be carried out before selection of the antithrombotic therapy.

Determination of dansylated amino acids and biogenic amines in Cannonau and Vermentino wines by HPLC-FLD.

Free amino acids (AA) and biogenic amines (BA) were quantified for the first time in Cannonau and Vermentino wines, the two most popular "Controlled Designation of Origin" wines from Sardinia (Italy). An analytical method for the simultaneous determination of AA and BA was developed, using selective derivatization with dansyl chloride followed by HPLC with fluorescence detection. Thirty-two compounds were identified in the wines analysed. High levels of AA were found, with proline being the most abundant with average levels of 1244 ± 398 and 1008 ± 281 mg/L in Cannonau and Vermentino wines, respectively. BA were detected at average concentrations <10mg/L, except putrescine which reached 20.5 ± 10.2mg/L in Cannonau wines. Histamine was never detected in any Vermentino wines. γ-Aminobutyric acid, 4-hydroxyproline, glycine, leucine+isoleucine and putrescine proved to be useful for differentiating Cannonau wines from Vermentino wines.

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.