Acute and mid-term results of phosphorylcholine-coated stents in primary coronary stenting for acute myocardial infarction.

The aim of this pilot study was to evaluate the safety and efficacy of the BiodivYsio phosphorylcholine-coated stent in the primary treatment of acute myocardial infarction. The BiodivYsio stent (Biocompatible) is a balloon-expandable stent, laser etched from a 316 L stainless steel tube. This device is coated with phosphorylcholine, a synthetic, hemocompatible phospholipid polymer that has been shown in experimental studies to reduce platelet and protein adhesion to the surface of the metal. One hundred consecutive patients within 24 hr of symptoms of onset of acute MI, treated with primary PTCA, were enrolled. After PTCA, stenting was attempted in all eligible lesions (reference diameter > or = 2.5 mm; no bend lesion > 45 degrees ). Poststenting regimens contained ticlopidine (500 mg/day) and aspirin (325 mg/day) and 6-12 hr of heparin infusion. Procedural success (TIMI > or = II and residual stenosis < 30%) was obtained in 70/74 cases (95%). TIMI grade III was restored in 90% of cases. In the patient group with procedural success (70 cases), 70 BiodivYsio stents were placed. After stenting, diameter stenosis decreased from 96% +/- 11% to 22% +/- 12% (P < 0.01) and minimal luminal diameter increased from 0.13 +/- 0.29 to 2.47 +/- 0.43 (P < 0.01). Nominal stent diameter was between 3.0 and 4.0 mm (mean, 3.5 +/- 0.4 mm). Stent length was between 11 and 28 mm (mean, 17 +/- 4.5 mm). Clinical follow-up was obtained in all patients; angiographic follow-up was performed in 65/70 (93%). No acute or subacute thrombosis was reported. Two in-hospital major adverse cardiac events (MACE) were reported due to a nontreated left main disease that required coronary artery bypass graft (CABG) surgery. At follow-up, MACE were found in 9 of 68 patients (13%), target lesion revascularization (TLR) in 6%, and CABG in the remaining 6%. Primary stenting with phosphorylcholine-coated stent leads to excellent short- and mid-term clinical outcomes and is associated with a restenosis rate of 12%.

Hypothesis and development of a minimally invasive approach for percutaneous transmyocardial revascularization with holmium laser.

BACKGROUND: Percutaneous transluminal myocardial revascularization (PTMR) is a new procedure to improve perfusion of the ventricular wall for patients with intractable angina and untreatable by surgery or conventional catheter-based intervention. Actually PTMR requires femoral approach to utilize 8F-9F system device. We now report the feasibility study of PTMR using a laser delivered through a novel Eclipse system and new 6F and 7F guiding catheters that allow to perform PTMR even in patients with peripheral vascular disease and particularly suitable for alternative small vascular access. METHODS: Percutaneous vascular access for PTMR treatment was obtained via the femoral or radial artery. A 6F or 7F mono-directional catheter carrying flexible fiber optics was used with a Holmium laser (Eclipse system) and was placed across the aortic valve into the left ventricular cavity to create channels of 5 mm in depth from the endocardial surface into the myocardial tissue. From June 1999 to September 2000, 39 patients (28 males, 11 females, mean age 72 +/- 8 years, range 58-86 years) underwent PTMR with the Eclipse system. Preoperative mean Canadian Cardiovascular Society (CCS) angina class was 3.5 +/- 0.5 and previous myocardial procedures had been performed in 39 patients (18 coronary artery bypass graft and 31 coronary angioplasty). RESULTS: The procedure was well tolerated and a procedural success was obtained in all patients (100%). We performed a mean of 19 +/- 7 channels in a mean fluoroscopy time of 21 +/- 9 min. We report only one procedural complication: one embolic stroke (2.4%). No hospital major adverse cardiac events were observed. The average length of hospital stay was 3.1 days. The mean CCS angina class at entry was 3.5 and it declined from 3.5 +/- 0.5 to 1.25 +/- 0.8 at discharge. At the follow-up of 8.2 +/- 3.9 months the mean CCS was 1.5 +/- 0.7. CONCLUSIONS: This experience confirmed the safety and technical feasibility of PTMR with this mini-invasive approach with a reduction in operative and fluoroscopy time. The PTMR with the 6F or 7F guiding catheter is feasible in high risk patients even when the femoral approach is contraindicated. Immediate and short-term results confirm that a clinical improvement is obtained in most patients.

Transcatheter mechanical thrombus aspiration for stent thrombosis.

Currently, in-stent thrombosis is a rare but serious clinical event. The mechanical or pharmacological approach has not totally solved this problem. In this report we describe the treatment of in-stent thrombosis with a new device for mechanical thrombus aspiration. We used the Rescue catheter (Rescue Catheter System, Boston Scientific), a new 4.5F dual lumen monorail catheter that was able to break and aspirate thrombus without evidence of distal embolization. In this case the procedure was quickly performed with good angiographic results after mechanical aspiration and additional traditional coronary angioplasty. Moreover, the excellent clinical outcome confirmed the efficacy of the technique in the percutaneous treatment of this late complication of stent implantation.

External cardioversion of atrial fibrillation: role of paddle position on technical efficacy and energy requirements.

AIM: To define the effect of defibrillator paddle position on technical success and dc shock energy requirements of external cardioversion of atrial fibrillation. METHODS: 301 patients (mean (SD) age 62 (11) years) with stable atrial fibrillation were randomly assigned to elective external cardioversion using anterolateral paddle position (ventricular apex-right infraclavicular area; group AL (151 patients)) or anteroposterior paddle position (sternal body-angle of the left scapula; group AP (150 patients)). A step up protocol was used, delivering a 3 J/kg body weight dc shock, then a 4 J/kg shock (maximum 360 J), and finally a second 4 J/kg shock using the alternative paddle location. RESULTS: The two groups were comparable for the all clinical variables evaluated. The cumulative percentage of patients successfully converted to sinus rhythm was 58% in group AL and 67% in group AP with low energy dc shock (NS); this rose to 76% in group AL and to 87% in group AP with high energy dc shock (p = 0.013). Thirty seven patients in group AL and 19 in group AP experienced dc shock with the alternative paddle position; atrial fibrillation persisted in 10/37 in group AL and in 10/19 in group AP. Mean dc shock energy requirements were lower for group AP patients than for group AL patients, at 383 (235) v 451 (287) J, p = 0.025. Arrhythmia duration was the only factor that affected the technical success of external cardioversion (successful: 281 patients, 80 (109) days; unsuccessful: 20 patients, 193 (229) days; p < 0.0001). The success rate was lower if atrial fibrillation persisted for > 6 months: 29 of 37 (78%) v 252 of 264 (95%); p = 0.0001. CONCLUSIONS: An anteroposterior defibrillator paddle position is superior to an anterolateral location with regard to technical success in external cardioversion of stable atrial fibrillation, and permits lower dc shock energy requirements. Arrhythmia duration is the only clinical variable that can limit the restoration of sinus rhythm.

Percutaneous transmyocardial revascularization with holmium laser in patients with refractory angina: a pilot feasibility study.

BACKGROUND: Percutaneous transluminal myocardial revascularization (PTMR) is a new procedure to improve perfusion of the ventricular wall for patients with intractable angina that is untreatable by surgery or conventional catheter-based intervention. PTMR allows the creation of myocardial channels through the controlled delivery of holmium laser energy from the ventricular chamber. Preliminary studies in animals and human subject have yielded promising results. We now report the feasibility study of PTMR using a laser delivered through a novel Eclipse system, and we present the results of this sole therapy in patients with severe coronary disease and angina refractory to maximal medical treatment angina (III-IV CCS). METHODS: Percutaneous vascular access for PTMR treatment was obtained via the femoral artery. A 9F directional catheter carrying flexible fiber optics was used with a holmium laser (Eclipse system) and was placed across the aortic valve into the left ventricle cavity to create channels with a depth of 5 mm from the endocardial surface into the myocardial tissue. From April to November 1998, 15 patients underwent PTMR with Eclipse system. Two patients were female; the mean age was 66 +/- 8 (range 59-74). Five patients had a severe LV dysfunction (FE < 30%). Preoperative angina class was III in 10 patients and IV in 5 and previous myocardial procedures had been performed in all patients. RESULTS: The procedure was well tolerated and procedural success was obtained in 14 of 15 patients. There was one myocardial perforation because of guiding-catheter manipulation (pericardial drainage in fourth day). We performed a mean of 13 +/- 4 channels in a mean fluoro time of 23 +/- 11 min. Upon release and during follow-up (5.3 months +/- 4.2, range 2-10), angina class had significantly improved in 14 of 14 patients with complete PTMR treatment, with 4 asymptomatic patients, 6 patients in CCS I, 3 in CCS II, 2 in CCS III and only one patient hospitalized due to angina. CONCLUSION: This pilot study confirmed the safety and technical feasibility of PTMR. Immediate and short-term results confirm that a clinical improvement is obtained in most patients. Although these are early clinical benefits, the true efficacy of this approach will necessarily be defined by a randomized trials with prospectively-defined endpoints and with PTMR compared with medical therapy.

[Primary angioplasty in acute myocardial infarct with or without a stent implant: the experience and results at 6 months in the first 200 patients]. / Angioplastica primaria nell'infarto miocardico acuto con o senza impianto di stent: esperienza e risultati a sei mesi nei primi 200 pazienti.

BACKGROUND: Although it is superior to thrombolysis, primary PTCA does have some limitations, both in hospital (recurrent ischemia and reinfarction due to reocclusion of the infarct-related artery) and at the six-month follow-up (high rate of late restenosis). Coronary stenting is a promising way of solving some of these problems, even if its use in patients with acute myocardial infarction could prove to be controversial because of intracoronary thrombus. In this study, we propose two procedural strategies in the treatment of the infarct-related artery (IRA): the search for optimal angiographic results after PTCA ("stent-like result"--SLR--with residual stenosis < or = 20%--no dissection--TIMI III flow) or intracoronary stenting when SLR was not obtained after a second inflation. METHODS AND RESULTS: From December 1995 to May 1998, 200 patients with AMI underwent direct PTCA or rescue PTCA because of failed thrombolysis. There were 143 men and 57 women, mean age 65 (range 36-84). Nineteen patients were in cardiogenic shock and 25 were in Killip class > II. Recanalization of the IRA was achieved in 196 patients (98%). In four patients, it was not possible to cross total occlusion with the guide-wire. SLR post-PTCA was achieved in 40 patients (20%). Stents were placed in 147 patients (75%), with "elective" implantation in 73 lesions because of suboptimal results after PTCA in 41, and early loss or coronary dissection with threatening occlusion in 33. In nine patients without SLR, stenting was not performed because of diffuse disease of the IRA. In-hospital complications included ten deaths (8 of 19 patients with cardiogenic shock at admission and 2 with multivessel disease and severe left ventricular dysfunction). None of the patients required emergency coronary bypass for procedural complications. One patient had a subacute thrombosis on the third day after bail-out stent implantation (re-PTCA). Five patients required elective bypass surgery to complete revascularization for multivessel disease with ten days after the surgical procedure. At the six-month follow-up, one patient had died of cardiogenic shock. Eleven (5%) patients with bail-out procedures underwent coronary bypass surgery or PTCA. Thirty-one patients (31/168) had recurrence of ischemia: 15 patients in the stent group, 11 in SLR group and 5 in the non-SLR group. Re-PTCA was performed in 20 patients, CABG in five and medical therapy in six. Other patients were angina-free at follow-up. CONCLUSIONS: Based on our experience, seeking optimal angiographic results with or without (SLR) stent implantation is a safe and effective operative approach to achieve the best procedural and clinical outcome and reduce complications in patients undergoing PTCA for AMI.

[Clinical experience with the use of implantable vascular systems in advanced heart failure]. / Esperienza clinica di utilizzo dei sistemi per accesso vascolare impiantabili nelle cardiopatie in stadio avanzato.

BACKGROUND: Patients with end-stage cardiomyopathy frequently require acute or chronic infusional treatments and long hospitalization. Availability of a simple and safe vascular access is a true necessity for these patients, especially in case of inotropic or diuretic outpatient treatment. In this study we have evaluated the usefulness and the applicability of implantable vascular access in the management of end-stage cardiomyopathy. Technical problems and both short and long term complications have been analysed. METHODS: Nineteen implantable vascular system (16 Port-A-Cath, Pharmacia; 3 Celsite, Bruneau) have been implanted in a group of 15 patients with end-stage cardiomyopathy. All patients had been previously hospitalized and needed prolonged infusional therapy. Implantation was performed in local anaesthesia with technique derived from pace-maker implantation. RESULTS: All the interventions were well tolerated, average procedural time was 30 min (range 20-60 min). No procedural complications occurred. Re-implantation of the system was required in 2 patients due to catheter thrombosis, In 1 patient due to catheter rupture caused by wrong positioning of infusion needle, and in 1 patient due to inflammatory reaction. In 2 further cases catheter thrombosis was treated with local infusion of urokinase. In 1 patient the catheter was repositioned after dislocation. The average in situ permanence of the systems was 8 months (range 15 day-18 months). CONCLUSIONS: Vascular implantable systems have proved useful and easily applf1p4e in the management of patients with end stage cardiomyopathy. After training some of the implied complications are easily avoidable. The use of this device has concurred to reduce duration and frequency of hospitalizations.

[The use of myoglobin for the early diagnosis of reperfusion in acute myocardial infarct]. / Impiego della mioglobina per la diagnosi precoce di riperfusione nell'infarto miocardico acuto.

Myoglobin (Mb) is an intracardiac protein known to be rapidly released after onset of reperfusion. The new automated latex-enhanced nephelometric immunoassay is an interesting fast alternative to the other methods. Therefore we sought to assess the accuracy of rapid rise of Mb concentration to predict the success of reperfusion. Thirty consecutive patients, admitted to the coronary care unit for first acute Q-wave myocardial infarction, were prospectively studied. They underwent thrombolysis 126 +/- 45 min (range 30-180) after onset of symptoms. Mb determinations were obtained before starting therapy and, thereafter, hourly for 5 hours, and after 8 and 12 hours. The usual non invasive markers of reperfusion were considered, and coronary arteriography was performed in all patients at 5.5 +/- 0.9 days (range 1-6). In 23 patients (77%) patent infarct-related artery (IRA) (TIMI II-III) and in 7 (23%) occluded IRA (TIMI 0-I) was observed at coronary arteriography. We modified the judgment in 3 cases (10%) with occluded IRA. All reperfused patients (Group A) showed a rapid rise of Mb concentration with a mean time to peak occurring 133 +/- 80 min (range 60-180) after therapy. Mean value of unreperfused patients (Group B) was 330 +/- 173 min (range 180-420). We retrospectively stated a time to peak of Mb concentration within 180 min as diagnostic threshold for reperfusion. Sensitivity was 100%, specificity 50%, positive predictive value 93%, negative predictive value 100%. The results of this study confirm that Mb release kinetics may play an interesting role in the early prediction of patency of IRA in acute myocardial infarction after thrombolysis.(ABSTRACT TRUNCATED AT 250 WORDS)