Percutaneous intervention of de novo unprotected left main stenosis in patients with acute coronary syndrome or stable coronary artery disease: in-hospital and long-term results.

OBJECTIVES: to assess in-hospital and long-term results of the novo unprotected left main (UPLM) percutaneous coronary intervention (PCI) in patients with acute coronary syndrome (ACS) or stable coronary artery disease (CAD), in an unselected population admitted to a single high- volume cathlab without on-site cardiac surgery. METHODS: from 2008 to 2011, among 317 PCI performed in patients with the novo UPLM stenosis, 49 patients presented ST-elevation myocardial infarction (STEMI), 152 non ST-elevation MI/unstable angina (NSTEMI/UA), 116 stable CAD. RESULTS: in-hospital mortality was 20% in STEMI, 5.3% in NSTEMI/UA and 1.7% in stable CAD patients (p<0.001). Two-year total mortality was 24.5%, 25.6% and 6% in the 3 groups, and cardiac death was 20%, 13.8% and 3.4% (p=0.002). Left main target lesion revascularization (TLR) was similar in the 3 groups, as the clinically- driven TLR (10% vs 11% vs 7.7% , p= 0.642), with neither definite nor probable stent thrombosis. Multivariate analysis showed the following independent predictors of 2-year mortality: bare-metal stent use (OR 4.53, p<0.001), Syntax score >32 (OR 3.53, p=0.012), ACS as the indication (OR 3.24, p=0.012), peripheral artery disease (OR 2.20, p=0.042), and age > 75 years (OR 2.09, p=0.05). CONCLUSIONS: our experience showed acceptable results of UPLM PCI in STEMI patients, where short-term prognosis was related to hemodynamic conditions, good results in NSTEMI/UA patients where mortality increased in the follow-up due to comorbidities, and very good results in patients with stable CAD.

Percutaneous rheolytic thrombectomy with the AngioJet System for the treatment of intermediate-risk acute pulmonary embolism: a case report and an appraisal of contemporary indications and technique.

Percutaneous mechanical thrombectomy (PMT) for treatment of clinically significant pulmonary embolism (PE) has been shown to be technically feasible and effective, aiming at thrombus resolution without increase in major bleeding. Despite its success, use of PMT in clinical practise has not become widespread, because it is challenging. Among several devices proposed, AngioJet rheolytic thrombectomy (ART) appears as the most effective and easy-to-use. We present the case of a 69-year-old woman who developed acute intermediate-risk PE, with right ventricular dysfunction and major myocardial necrosis, who was successfully treated by ART. The peculiarities of the case, toghether with the principles, tecnique and tips and tricks of ART, its effectiveness and potential complications are discussed.

Acute myocardial infarction caused by multivessel spontaneous coronary artery dissection in a postpartum woman.

Spontaneous coronary artery dissection is a rare cause of acute ischemic coronary events and sudden cardiac death. It usually occurs in young women not experiencing traditional risk factors for coronary artery disease during pregnancy or postpartum period. The pathophysiology of spontaneous arterial dissection remains uncertain and the management may be challenging. Herein, we report a case of a 41-year woman with no apparent cardiovascular risk factors, who underwent a successfull in vitro fertilization and embryo transfer with a subsequent at term cesarean section of a twin pregnancy. Six days after delivery, she presented with anterior ST-segment elevation myocardial infarction. Coronary angiography revealed dissection of all three coronary arteries with involvement of left main stem, which was successfully treated with percutaneous coronary intervention and drug-eluting stents implantation. The peculiarities of the case, toghether with the treatment strategy and the clinical and angiographic six-month follow-up are discussed.

Direct coronary stenting versus stenting with balloon pre-dilation: incidence of enzyme release and follow-up results of a multicentre, prospective, randomized study. The CK and Troponin I Estimation in direct STenting (CK TEST) trial.

AIM: The aim of this study was to assess the safety of direct coronary stenting, its influence on costs, duration of the procedure, radiation exposure, clinical outcome and the incidence of periprocedural myocardial damage as assessed by enzyme release determination. METHODS: We randomized 103 patients (109 lesions) to direct stent implant or stent implant following balloon predilatation. Patients with heavily calcified lesions, bifurcations, total occlusions, left main lesions and very tortuous vessels were excluded. Three samples of blood were drawn; before, 12 and 24 h after the procedure and total CK, CK MB mass and troponin I determination was carried out in a single centralized laboratory. RESULTS: Direct stenting was successful in 62/62 lesions (100%). No single loss or embolization of the stent occurred. All stents in the group with predilatation were effectively deployed. The immediate post procedure angiographic results were similar with both techniques. Contrast media consumption and procedural time were significantly lower in direct stenting (150+/-82 cc and 30+/-13 min) than in pre-dilated stenting (184+/-85 cc and 36+/-14 min) (P=0.04 and P=0.036 respectively) while fluoroscopy time was similar (9.1+/-12 vs 9.19+/-15 min, P=0.97). The incidence of enzyme release was similar in the groups with only three non Q MI all in the pre-dilated group (P=0.149). Any elevation of CK MB and troponin I occurred in 7% of direct stent vs 12% of pre-dilated group (P=0.66), isolated troponin I elevation in 21% of both groups. Major adverse cardiac events during hospitalization were 0 in direct and 3 in pre-dilated stenting (P=0.66), but there were no significant differences at follow-up at 1, 6 and 12 months between the 2 groups (target lesion revascularization at 12 months 11 vs 14% in the 2 groups respectively). CONCLUSION: Direct stenting is as safe as pre-dilated stenting in selected coronary lesions. Acute results and myocardial damage as assessed by enzyme release determination are similar, but procedural costs (as measured by resource consumption) and duration of the procedure are lower in direct stenting. Overall success rate and mid-term clinical outcome are similar with both techniques.

Starc II, a multicenter randomized placebo-controlled double-blind clinical trial of trapidil for 1-year clinical events and angiographic restenosis reduction after coronary angioplasty and stenting.

The objective of this study was to investigate the effect of trapidil 200 mg t.i.d. in preventing the occurrence of death, of myocardial infarction and the need for repeat revascularization at 12 months after balloon PTCA with or without stenting. Coronary restenosis after stenting is still a major drawback of percutaneous coronary interventions (PCI) for 30-40% of patients. Trapidil has been shown to prevent restenosis after PTCA. Eligible patients were randomized to placebo or oral trapidil 200 mg t.i.d. at least 48 hr before PCI and continuing 6 months after a successful balloon angioplasty or stent implantation. Aspirin was given to all patients, and ticlopidine 250 mg b.i.d. to those who received a stent for 4 weeks. In a randomized subgroup of 216 patients, quantitative coronary angiography was performed also at 6-month follow-up. Out of the 933 patients enrolled, primary endpoint incidence was 20.3% in trapidil and 18.0% in placebo (P = 0.37). When recurrence or deterioration of angina was added to the combined endpoint, incidence was 27.4% in trapidil and 23.0% in placebo (P = 0.12). Restenosis rate in patients with 6-month angiography was 25.0% in trapidil arm vs. 30.1% in placebo (P = 0.43). Stent restenosis rate was similar in patients randomized to trapidil or placebo (30.2% vs. 23.8%, respectively; P = 0.44), while in patients treated with balloon angioplasty, it was lower in trapidil (17.1%) than in placebo (40.0%; P = 0.03). Oral trapidil 200 mg t.i.d. for 6 months in addition to aspirin did not influence the occurrence of major cardiac events after coronary angioplasty with or without stenting. In a prespecified subgroup of 191 patients treated with balloon angioplasty only, trapidil reduced angiographic restenosis.

[Cost of diagnostic and therapeutic hemodynamic procedures: comparison with DRG reimbursement]. / Costo delle procedure emodinamiche diagnostiche e terapeutiche: confronto con il rimborso secondo DRG.

BACKGROUND: The cumulative costs of diagnostic and interventional procedures in the catheterization laboratory in public hospitals are still largely unknown, notwithstanding the present stress upon the cost-effectiveness issues in medicine. METHODS: From January through April 2000 we have evaluated procedures in the catheterization laboratory of the Ravenna USL. Costs taken into consideration were the following: the mean cost of materials for each type of examination and of medications used for each patient, personnel costs, machinery mortgages' costs, ambulance transportation's costs, and general hospital expenditures. DRGs and reimbursements have been calculated on the basis of clinical indications and modalities of procedures. RESULTS: During the evaluation period 268 patients have been studied. The procedures taken into consideration included: 135 coronary angiographies, 36 right and left catheterizations plus coronary angiography, 87 coronary angiographies plus percutaneous coronary intervention (PCI), 10 PCI. The total cost of diagnostic catheterization was Itl 1,226,000 (Euro 632) whereas that of each PCI (including stent implantation in 80% of cases) associated in 87 cases with coronary angiography was Itl 5,956,000 (Euro 3044). Patients with an acute coronary syndrome or heart failure were mostly studied during their first hospital stay; those with stable disease (stable angina, previous myocardial infarction, valvular heart disease or cardiomyopathy without heart failure) were studied during ordinary hospital admission or in the context of a day-hospital. DRGs and corresponding reimbursements for the different clinical situations were the following: unstable angina DRG 124 valued at Itl 6,180,000; stable angina DRG 125 valued at Itl 3,900,000; acute or recent myocardial infarction with or without complications DRG 121 or 122 valued at ItI 8,290,000 or Itl 5,900,000; heart failure in valvular heart disease or cardiomyopathy DRG 124 valued at Itl 6,180,000; valvular heart disease or cardiomyopathy DRG 125 valued at Itl 3,900,000. The DRG for a PCI is no. 112 valued at Itl 10,235,000. CONCLUSIONS: The costs of diagnostic and interventional hemodynamic procedures were acceptable and proportional to the DRG-related reimbursements. Appropriately indicated procedures and their quick execution during the first hospital stay lead to global economic savings for the health care system and are also clinically advantageous for the individual patient.

Coronary restenosis after optimal (stent-like) initial angiographic results obtained by traditional balloon angioplasty.

BACKGROUND AND OBJECTIVE: Elective native coronary artery stenting has shown its efficacy in lowering restenosis rates (RR) usually occurring after balloon angioplasty (PTCA). However ability of conventional PTCA to consistently provide low RR, through the achievement of large acute stent-like angiographic results, has not been investigated. This study was conducted to: (1) assess ability of optimal initial dilatation (OID), defined by residual lumen narrowing < or = 20%, significantly reduce current high RR following traditional PTCA; (2) evaluate the efficacy of OID obtainable by conventional PTCA in influencing adverse effects of single variables predisposing to restenosis. METHODS: Of consecutive 601 patients who underwent PTCA, 569 (94.6%), 483 men and 86 women, aged 38-76 years, had a successful procedure on 645/678 lesions (95.1%). After a plaque fracture was obtained by the first inflation, step-increases in pressure of 1 atm and 60 second-inflation-times were applied, until a large lumen (the nearest to normal) and smooth contours were seen, or any wall damage detected by using step-by-step angiographic tests. Acute optimal results (group A) were 450 (69.7%) and sub-optimal results (group B) were 203 (30.3%). After a mean time of 9 +/- 1.8 months, 543 patients (95.4%) had angiographic restudy on 611 (94.7%) successfully treated lesions. RESULTS: Restenosis (> 50% stenosis at restudy) occurred in 27.1% of patients and in 24.5% of lesions. RR was 18.8% in group A and 37.8% in group B (p < 0.0001). Significant lower RR were observed in group A in comparison with group B, for single variables examined, except for length > 10 mm. By multivariate analysis of all treated lesions, sub-optimal initial dilatation, unstable angina, lesion length > 10 mm and eccentricity emerged as major determinants of restenosis. Following OID only length > 10 mm was highly predictive of this event and, in the absence of this adverse variable, RR was only 13.6%. CONCLUSION: Counterbalancing adverse effects of many variables predisposing to restenosis, OID obtained by traditional PTCA seem to significantly reduce the risk of recurrence, particularly in lesions no longer than 10 mm.

[Presence of patent foramen ovale in different heart diseases: incidence in 211 consecutive patients studied by transesophageal echocardiography]. / Presenza di forame ovale pervio in diverse cardiopatie: incidenza in 211 pazienti consecutivi studiati con eco transesofageo.

BACKGROUND: Contrast echocardiography during the decompression phase of the Valsalva manoeuvre in course of transesophageal echo study is the ideal method to identify patent foramen ovale. METHODS: In order to evaluate the incidence of patent foramen ovale in patients with different cardiac diseases we performed contrast injection in 211 consecutive pts submitted to TEE (Transesophageal Echocardiography) in our laboratory between march 1991 and march 1993. RESULTS: Fiftythree of 211 pts (25%) presented a patent foramen ovale. The incidence in the different cardiac diseases was as follows: 0% in rheumatic mitral disease, 23% in aortic valve disease, 17% in mitral and/or aortic valve prosthesis, 29% in congenital heart disease other than interatrial septal defect, 44% in mitral valve prolapse and 92% in atrial septal aneurysm. CONCLUSIONS: This study indicates that patent foramen ovale is a common finding in different cardiac pathologies and frequent in mitral valve prolapse and even more in atrial septal aneurysm. In case of peripheral embolism of likely cardiac origin, the patency of the foramen ovale must be recognized, especially when these two latter cardiac anomalies are identified.

Trapidil (triazolopyrimidine), a platelet-derived growth factor antagonist, reduces restenosis after percutaneous transluminal coronary angioplasty. Results of the randomized, double-blind STARC study. Studio Trapidil versus Aspirin nella Restenosi Coronarica.

BACKGROUND: Trapidil is an antiplatelet drug with specific platelet-derived growth factor antagonism and antiproliferative effects in the rat and rabbit models after balloon angioplasty. METHODS AND RESULTS: The Studio Trapidil versus Aspirin nella Restenosi Coronarica (STARC) is a multicentric, randomized, double-blind trial to assess the effects of trapidil in angiographic restenosis prevention after percutaneous transluminal coronary angioplasty (PTCA). Patients received either trapidil 100 mg TID or aspirin at the same dosage at least 3 days before angioplasty and for 6 months thereafter. Coronary angiograms before PTCA, after PTCA, and at 6-month follow-up were quantitatively analyzed with manual calipers. Of the initial 384 patients recruited, 254 were evaluable for restenosis analysis (128 trapidil, 126 aspirin). Restenosis, defined as a loss of initial percent gain after PTCA of at least 50% (primary end point), occurred in 24.2% of the trapidil group and 39.7% of the aspirin group (P < .01). A similar result was obtained when restenosis per vessel was considered (trapidil, 23.3%; aspirin, 36.9%; P = .018). Clinical events at follow-up were similar in the two groups except that recurrent angina was significantly more frequent in the aspirin group, 43.7% versus 25.8% in the trapidil group (P < .01). Trapidil was well tolerated: only 6 patients had to discontinue the drug because of side effects, which was not different from the aspirin group. CONCLUSIONS: Trapidil reduces restenosis after PTCA at the dosage of 100 mg TID and favorably influences the clinical outcome thereafter.

The trapidil restenosis trial (STARC study): background, methods and clinical characteristics of the patient population.

Restenosis remains the principal drawback of percutaneous transluminal coronary angioplasty (PTCA) since 30-35% of patients still experience it 6 months after the intervention. Several studies have clearly demonstrated that restenosis is a complex multifactorial process that involves smooth muscle cell (SMC) migration and proliferation in the intimal layer of the coronary artery. Among others, the platelet-derived growth factor (PDGF) seems to play an important role in this process. That is why researches have been made in finding and developing new agents able to inhibit PDGF. Trapidil (triazolopyrimidine) (T), is a potent PDGF inhibitor that has been efficacious in preventing restenosis after balloon angioplasty in the experimental animal and after PTCA in a limited clinical trial. The Trapidil Restenosis Trial (STARC study) is a double blind randomized trial of T 100 mg t.i.d. vs. Aspirin (ASA) 100 mg t.i.d. 360 patients have been enrolled from April 1990 until May 1992, excluding recent myocardial infarctions, thrombolysis, restenotic and venous graft lesions and 302 have terminated follow-up. This paper describes the clinical background, the protocol and baseline data of the patient population including data regarding initial stenosis and type of vessel treated.

Noninvasive prediction of restenosis after coronary angioplasty: a head to head comparison among exercise ECG, dipyridamole and exercise thallium scintigraphy.

Restenosis remains the main limitation of percutaneous transluminal coronary angioplasty (PTCA). Since it seems likely that restenosis not severe enough to induce ischemia may be better detected with pharmacological testing than with exercise, we investigated whether dipyridamole thallium scintigraphy is better than exercise-electrocardiogram and exercise-thallium in predicting restenosis after PTCA. Noninvasive tests and re-angiography were performed in 61 consecutive patients, 5-6 months after successful single vessel PTCA. Detection of vessel stenosis greater than or equal to 50% was used as angiographic criteria for restenosis. Exercise-induced angina, ST segment depression greater than or equal to 1 mm at exercise-electrocardiogram and reversible perfusion defects in the area supplied by the dilated vessel, during either dipyridamole and exercise-thallium, were considered noninvasive abnormal responses. The overall restenosis rate was 41% (25/61). Angina was the most specific (97%) of all criteria for restenosis, but also one of the least sensitive (40%), slightly better than exercise-ECG (24%). Exercise-thallium had lower sensitivity (72% vs 88%, p less than 0.05) and negative predictive value (82% vs 91%, p less than 0.05) than dipyridamole-thallium. In patients positive at both exercise-thallium and dipyridamole-thallium testing, mean stenosis at follow-up was more severe (73 +/- 23%) than in patients with positive dipyridamole-thallium and negative exercise-thallium (55 +/- 26%) results, but the difference did not reach statistically significant levels. For these reasons, dipyridamole-thallium seems to be an acceptable alternative to exercise thallium to follow patients after initially successful PTCA.

[The coronary angioplasty of oversized vessels by the hugging-balloon and single guiding-catheter technic: a case report]. / Angioplastica coronarica di vasi sovradimensionati con tecnica del doppio pallone e catetere guida singolo: descrizione di un caso.

A case is described of percutaneous coronary angioplasty performed on an oversized right coronary artery (> 7 mm), using the hugging balloon technique. The procedure and the equipment utilized are described.

A double-blind crossover comparison of flecainide and slow-release mexiletine in the treatment of stable premature ventricular complexes.

In 24 patients with stable premature ventricular contractions (PVCs) greater than or equal to 100/h, Lown class greater than or equal to 2 the relative anti-arrhythmic efficacy of flecainide 150 mg twice daily and slow-release mexiletine 360 mg twice daily was evaluated in a double-blind placebo-controlled randomized crossover study. All the patients had normal ventricular function. Criteria of efficacy were: reduction greater than or equal to 70% of PVCs or reduction greater than or equal to 50% with abolition of Lown class greater than 2 arrhythmias or suppression of non-sustained ventricular tachycardias (nSVT). Twenty-two patients completed the study protocol. The placebo phases showed comparable results and no carry over effect. The criteria of efficacy were fulfilled in 20 of the 22 patients (91%) on flecainide and in 12 of the 22 (55%) on mexiletine. The absolute reductions of PVCs, couplets and nSVT obtained on flecainide and mexiletine, in comparison to the placebo, were statistically significant (p less than 0.01 for flecainide, p less than 0.05 for mexiletine). Flecainide was superior to mexiletine in overall PVC reduction (p less than 0.05). In the 17 patients with couplets the reduction obtained with flecainide was superior to mexiletine (p less than 0.05). Both drugs were highly effective on nSVT. At steady state, the mean plasma levels of both drugs were within the range of clinical efficacy. The drugs were well tolerated and no patient withdrew because of side-effects. It was concluded that at the dosages employed flecainide was superior to mexiletine in reducing premature ventricular contractions and in abolishing couplets. The efficacy of both drugs for non-sustained ventricular tachycardias was comparable. Both drugs were highly effective by comparison with the placebo.

Minimal effective concentration values of propafenone and 5-hydroxy-propafenone in acute and chronic therapy.

We evaluated the antiarrhythmic efficacy and the minimal effective concentrations of propafenone and its metabolite 5-hydroxy-propafenone during a) acute intravenous infusion (1.5 mg/kg in bolus followed by 45 minutes infusion), b) an acute oral single-dose test (450 mg), and c) 14-day chronic therapy (300 mg tid) followed by a washout. Oxidative metabolism was assessed by a debrisoquine oral test in every patient. Eleven patients with stable ventricular premature beats (VPBs) greater than or equal to 300/hr and Lown class greater than or equal to 3 completed the study. The main results emphasized a certain discrepancy between the clinical effect of the acute intravenous infusion (efficacy in 5 out of 11 patients) and of the acute oral test and chronic therapy (efficacy in 11/11), with a time lag of the ECG changes during the acute intravenous infusion. The minimal effective concentrations were lower after acute oral administration compared with chronic treatment both for propafenone (200 +/- 189 ng/ml vs. 492 +/- 530 ng/ml; p less than 0.05) and for 5-hydroxy-propafenone (82 +/- 40 ng/ml vs. 149 +/- 80 ng/ml; p less than 0.02). A linear correlation was demonstrated between drug/metabolite ratios of propafenone and debrisoquine, either after acute oral (r = 0.91) or after chronic administration (r = 0.84). The pharmacokinetics of propafenone was nonlinear and showed wide interindividual variations.(ABSTRACT TRUNCATED AT 250 WORDS)

[Paroxysmal atrial fibrillation: study of the pattern of onset using dynamic electrocardiography]. / Fibrillazione atriale parossistica: studio delle modalità d'innesco mediante elettrocardiografia dinamica.

UNLABELLED: We have examined 24 hours ECG Holter recordings of 22 patients without any organic heart disease and with recurrent episodes of paroxysmal atrial fibrillation (PAF) to check the possible sympatho-vagal influence on spontaneous initiation. Patients were divided into 3 groups according to average heart rate (HR) during the 24 hours recording and to the mode of onset of the arrhythmia: sympathetic (only diurnal episodes, HR greater than or equal to 75 b/min before the onset of the episode, average 24 hours HR greater than or equal to 80 b/min, progressive or sudden shortening of sinusal cycle before the onset), vagal (only nocturnal episodes, HR less than or equal to 60 b/min before the onset, average 24 hours HR less than or equal to 60 b/min, progressive or sudden lengthening of sinusal cycle before the onset of the episode) or "others" who did not show the aforementioned characteristics. RESULTS: there are not only 2 types of patients under prevalent sympathetic or vagal control but even patients who show mixed patterns; in the sympathetic group there are significant differences between ectopic atrial beats (EAB) that start a PAF and isolated EAB in: prematurity index (0.51 +/- 0.11 vs 0.45 +/- 0.07; p less than 0.001) coupling time (381 +/- 36 ms vs 419 +/- 48 ms; p less than 0.005), sinus cycle length (PP) before the onset of the arrhythmia (761 +/- 192 ms vs 950 +/- 175 ms; p less than 0.001).(ABSTRACT TRUNCATED AT 250 WORDS)

[Electrocardiographic, clinical and prognostic evaluation of sustained ventricular tachycardia in acute and chronic ischemic heart disease]. / Valutazione elettrocardiografica clinica e prognostica della tachicardia ventricolare sostenuta in corso di cardiopatia ischemica acuta e cronica.

We retrospectively evaluated 48 patients with sustained ventricular tachycardia (STV), in whom a 12 lead ECG had been recorded during arrhythmia, considering two groups: pts. with acute or subacute myocardial infarction (MI group = 15 pts.) and pts. with chronic post infarction ischemic heart disease (CPIIHD group = 33 pts.). The electrocardiographic patterns in the basal ECG and during SVT (16 SVT in the MI group, 40 in the CPIIHD group) as well as the in-hospital and long-term prognosis were evaluated. The two groups were comparable as far as mean age, site of acute or previous infarction, and baseline ECG parameters are concerned. QTc values greater than 440 msec were present in 64.5% of the cases. The ECG recording during SVT showed longer duration of QRS in CPIIHD group (171 +/- 39 msec) versus MI group (140 +/- 25 msec) (p less than 0.005). In comparison to basal ECG, Q waves in the SVT recording were in the same site (47.2%) or in a wider site (38.1%), rarely (10.9% of the cases) there was a discordance between the two tracings. In-hospital mortality was 40% (6/15 pts.) in MI group, related to severe hemodynamic impairment, 15.1% (5/33 pts.) in CPIIHD group. During the follow-up (mean 38.4 months) survival in CPIIHD group was 89.3% at 12 months, in MI group 88.9% at 12 months. In CPIIHD patients SVT was recurrent in 60.6% of the cases.(ABSTRACT TRUNCATED AT 250 WORDS)