First experience with the Impella Recover(R) LP 2.5 micro axial pump in patients with cardiogenic shock or undergoing high-risk revascularisation.

AIM: To study the feasibility, safety and efficacy of the Recover(R) LP 2.5 assist device in patients scheduled for high risk off-pump coronary bypass surgery, percutaneous coronary intervention or patients in cardiogenic shock. METHODS AND RESULTS: 40 patients presenting with cardiogenic shock (n=13) or scheduled for a high risk revascularisation (n=27) were included.36 were selected for safety and feasibility analysis. In 3 patients the pump could not be placed in an adequate position. 5 patients had access related complications. In 9 patients free Hb rose above 80 mg/dl. 3 malfunctions and early device-removal occurred. After device modifications these problems did not recur. CO in the shock group increased significantly: 4.4 l/min+/-1.9 to 4.8 l/min+/-1.2 (p=0.0178).The left ventricular filling pressures decreased in both groups (22 mmHg+/-7.5 to 16 mmHg+/-6 in the shock group, [p=0.0008] and over 6 hours from 14.3 mmHg+/-5.8 to 10 mmHg+/-2.9 in the high-risk revascularisation group,[p=0.0327]). CONCLUSIONS: The Recover(R) LP 2.5 micro axial pump allows, via percutaneous approach, partial unloading of the left ventricle. The technique is, after design modifications, feasible and safe and results in haemodynamic improvement.

Comparative endoluminal visualization of TAXUS crush-stenting at 9 months follow-up by intravascular ultrasound and optical coherence tomography.

We report a case of crush-stenting with Paclitaxel-eluting TAXUS stents in a left anterior descending artery (LAD) bifurcation lesion. In order to obtain precise information on the mid-term neointimal response of the main vessel to this approach, we evaluated the patient angiographically 9 months later, including intravascular visualization with optical coherence tomography (OCT), a new high resolution imaging technique, and IVUS. The evaluation revealed that there was a homogeneous neointimal coverage of the main vessel stents without evidence of significant recurrent lumen renarrowing or malappositions. Compared to IVUS, OCT proved the coverage of the stent struts adjacent to the vessel wall with a superior imaging quality and, in addition, provided new insights into the stent performance at the open bifurcation site.

Long-term evaluation of paclitaxel-coated stents for treatment of native coronary lesions. First results of both the clinical and angiographic 18 month follow-up of TAXUS I.

The development of restenoses due to tissue proliferation within the stented segment is a major limitation of conventional stent implantations. Recently published studies have shown that drug-eluting stents effectively decrease the incidence of stent restenosis at 6 month follow-up as compared to bare metal stents. However, a persistent efficacy of this stent design beyond the 6 month period still needs to be proven. Therefore, in this study, we are demonstrating the first 18 month follow-up results of a Paclitaxel-coated coronary stent, based on the patient population of the TAXUS I study, a multicenter randomized study to evaluate both safety and efficacy of the Paclitaxel-coated NIRx stent as compared to an uncoated, bare metal stent. In this study we evaluated the long-term outcome of NIRx patients of our center, in which 20 out of 31 patients of the TAXUS I study with NIRx stent implantation have been enrolled. A clinical follow-up was available in 20 out of 20 patients (100%) 535 +/- 82 days post stent implantation (17.8 months). An angiographic follow-up was available in 14 out of 20 patients (70%) 580 +/- 77 days post stent implantation (19.1 months). The MACE rate at 18 month follow-up was 0.0%. There was no stent restenosis in the study group up to 18 month post drug-eluting stent implantation. There was one non-clinically driven target vessel revascularization due to a stent edge lumen renarrowing, which was subsequently calculated as a 43% diameter stenosis. Accordingly, this event was not regarded as MACE. The IVUS analysis of the study population has shown a decrease of the mean minimum lumen area from 8.45 mm(2) postinterventional to 6.87 mm(2) at 6 month follow-up with a relative mean maximum plaque area of 16%. At 18 month follow-up, there were no additional significant changes with a mean minimum lumen area of 7.16 mm(2) and a relative mean maximum plaque area of 13.4%. The reported results of the 18 month follow-up of TAXUS I are the first experiences demonstrating a persistent benefit of the Paclitaxel-coated NIRx stent. Therefore, this stent design seems to be safe and effective, even in long-term follow-up.

Drug-eluting stents: clinical experiences and perspectives.

Drug-eluting stents (DES) have entered the arena and are about to changed the landscape of Interventional Cardiology. Today, the number of agents under preclinical and clinical investigation has increased considerably, including drugs such as Paclitaxel, Sirolimus, Tacrolimus, Everolimus, Dexamethasone, etc. Several studies have recently been published or are still ongoing evaluating different stent designs with respect to their safety and efficacy in treatment of coronary lesions. The SCORE trial (Paclitaxel) revealed a significant reduction in restenosis at follow-up (FU) in the drug-eluting stent group (6.4% vs 36.9% control group), attributable to decreased intimal proliferation. However, stentthromboses and myocardial infarctions, due to both stent design and high drug dosages, were observed causing a MACE rate of 10.2% in the DES group. Confirming the beneficial reduction of stent renarrowing using a local drug-eluting device, the rate of restenosis in the TAXUS-I trial (Paclitaxel) was 0% at follow-up in patients with DES vs 10% in patients with bare stents. Differences in MACE were not observed, which underlined the potential impact of an optimal stent design. First clinical experiences with a Sirolimus-coated stent (FIM trial) demonstrated again a profound inhibition of neointimal ingrowth at 4-month follow-up. The RAVEL trial, the first multicenter trial evaluating the Sirolimus stent and the largest DES study published so far, confirmed the FIM findings with a rate of restenosis in the DES group of 0% at 6 month FU. At 12 month FU, the beneficial impact on neointimal growth inhibition was persistent. The pivotal study SIRIUS is addressed to evaluate this stent design more extensively. However, given all the results being available today, local application of anti-proliferative agents delivered by coronary stents is one of the most promising techniques in treatment of coronary lesions. Nevertheless, we need more trials and an agreement of definitions in order to evaluate this treatment concept and eliminate unwanted side-effects.

[Brugada syndrome or ARVD (arrhythmogenic right ventricular dysplasia) or both? Significance and value of right precordial ECG changes]. / Brugada-Syndrom oder ARVD oder beides? Bedeutung und Wertigkeit rechtspräkordialer EKG-Veränderungen.

We report about a 20-year old patient suffering cardiopulmonary resuscitation due to ventricular fibrillation. We diagnosed Brugada syndrome after exclusion structural heart disease and a positive Ajmalin test and implanted an ICD. In that there is a 20-30% familiar disposition, it was necessary that all family members undergo a cardiac examination. It was found that one brother and one sister presented the beginning of a right ventricular dilatation and a fibrolipomatous area in the anterior wall segment of the right ventricle. This result is compatible with a "concealed" arrhythmogenic right ventricular dysplasia (ARVD). As a prognostic indication we decided to implant an ICD prophylactically. The case report demonstrates the value of familiar examination of patients with an unclear ventricular arrhythmogenic event.

Drug eluting stents: initial experiences.

Local delivery of immunosuppressive or antiproliferative agents using a drug-eluting stent is a new technology meant to inhibit in-stent restenosis providing both a biological and mechanical solution and has recently emerged as a very promising approach. Up to now several agents have been in use: Paclitaxel, Rapamycin, Actinomycin D or Tacrolimus. Evaluating these drugs regarding their release kinetics, effective dosage, safety in clinical practice and benefit, several studies have been published or are still ongoing: SCORE (Paclitaxel-derivative), TAXUS I, II, III, IV (Paclitaxel), ELUTE, ASPECT (Paclitaxel), RAVEL, SIRIUS (Sirolimus), ACTION (Actinomycin), EVIDENT, PRESENT (Tacrolimus). Paclitaxel was the first stent-based antiproliferative agent under clinical investigation providing profound inhibition of neointimal thickening, depending on delivery duration and drug dosage. The randomized multicenter SCORE trail (Quanam stent, Paclitaxel coated) enrolled 266 patients at 17 sites. At 6 month follow-up, a drop of 83% in stent restenosis using the drug-eluting stent could be achieved (6.4% drug-eluting stent vs. 36.9% control group) attributable to a remarkable decrease in intimal proliferation. Unfortunately, due to both frequent stent thrombosis and side-branch occlusions the reported 30-day MACE rate was 10.2%. The randomized TAXUS I safety trail (NIRx, Paclitaxel coated) also demonstrated beneficial reduction of restenotic lesions at 6-month FU (0% vs. 11%) but, this time, associated with the absence of thrombotic events presumably due to the lower drug dosage. The ongoing TAXUS II, III and IV trails are aimed at providing additional insight regarding the efficacy of the TAXUS Paclitaxel-eluting stent. Both the RAVEL and the SIRIUS trial have been conducted to evaluate a Sirolimus-coated stent (Bx VELOCITY stent). From the results available, the beneficial findings regarding reduction of renarrowing using a drug-eluting stent have been confirmed without any adverse effects. Although parameters like drug toxicity, optimal drug dosage or delayed endothelial healing need to be further evaluated, summarizing the today's clinical experience the strategy of drug-coated stents promises a striking benefit in interventional treatment of coronary lesions.

Prevention of distal embolization during coronary angioplasty in saphenous vein grafts and native vessels using porous filter protection.

BACKGROUND: Although distal embolization and the "no-reflow" phenomenon are well described in saphenous vein graft (SVG) interventions, the frequency, magnitude, and characterization of embolized debris have not been evaluated in routine coronary interventions. A unique embolus protection device described herein provides a means of containing and retrieving plaque material dislodged during percutaneous coronary interventions. This report details the first clinical experience of the effectiveness and safety of an emboli protection system in 11 SVG lesions and 15 native coronary artery lesions. METHODS AND RESULTS: The AngioGuard Emboli Capture Guidewire (Cordis) consists of a PTCA wire with an expandable filter at the distal tip. The porous membrane permits normal distal blood flow, while trapping potential emboli by filtration. After crossing the lesion, the filter is expanded, and routine angioplasty is performed over the same wire. Emboli retrieval is achieved by collapsing the filter and retracting the emboli capture wire (ECW). In 26 patients, standard angioplasty was performed over the ECW; 20 of these 26 patients received a stent. Collected debris was sent for histopathological analysis. Plaque debris was retrieved after native coronary and SVG interventions in all cases. The ECW was positioned and retrieved without complications. No major adverse events occurred. Myocardial infarctions and no-reflow were not observed. CONCLUSIONS: The embolization of plaque fragments frequently occurs during coronary and SVG intervention. Distal embolization leading to microvascular obstruction and no-reflow could be successfully minimized by using the ECW.

[Clinical experiences with the PercuSurge GuardWire--a new system for prevention of peripheral embolisms in catheter interventions on degenerated coronary artery venous bypasses]. / Klinische Erfahrungen mit dem PercuSurge GuardWire--ein neues System zur Vermeidung von peripheren Embolien bei Katheterinterventionen an degenerierten aorto-koronaren Venenbypässen.

Peripheral embolization is a typical complication of catheter interventions in degenerated aortocoronary saphenous vein grafts. Alternative techniques, such as transluminal extraction catheter (TEC), directional coronary athrectomy (DCA) and eximer laser angioplasty (ELCA) were not able to reduce the risk of peripheral vessel occlusion or "no-reflow". For the protection from peripheral embolisation we used the PercuSurge GuardWire Temporary Occlusion & Aspiration System (PercuSurge Inc., Sunnyvale, USA) in 55 patients with 58 stenosis in degenerated saphenous vein grafts. The primary endpoint of this consecutive series was to access the efficacy of the system by post-interventional TIMI flow and determination of serial CK/CK-MB. The intervention was primarily successful in 55 of 58 cases (94.8%), with a reduction in stenosis from 87.6% (range 75-100%) to 4.5% (range 0-40%). TIMI flow improved from a mean of 2.1 +/- 1.4 to 2.9 +/- 0.4 after intervention. CK/CK-MB levels were 24/5, 27/7 and 26/6 U/l (mean values) before, 8 hours, 16 hours and 24 hours after intervention, ruling out myocardial ischemia. Three (5.2%) non-q wave infarctions occurred in this series, twice caused by a peripheral embolization during the crossing of the lesion with the wire und once because of "no-reflow". In the latter case the occlusion balloon had to be deflated before the aspiration could be performed. In 80 of 92 aspirates (86.9%) macroscopic embolic debris was visible. The PercuSurge GuardWire Temporary Occlusion & Aspiration System is a safe and effective device for the protection of distal embolization during interventions in degenerated aorto-coronary saphenous vein grafts.

Management of arterial puncture site after catheterization procedures: evaluating a suture-mediated closure device.

To overcome the challenge associated with achievement in hemostasis after a catheterization procedure, a suture-based closure device was compared with manual compression in a 600-patient randomized trial. The major study end points included the incidence of vascular complications and the time to ambulation after the procedure. The study included diagnostic or interventional procedures. The suture-mediated closure was performed immediately after the procedure independent of the anticoagulation level, whereas manual compression was performed per hospital protocol with sheath removal relying on normalization of patient's anticoagulation status. A significant reduction in time to achieve hemostasis (7.8 +/- 4.8 vs 19.6 +/- 13.2 minutes, p <0001) and time to ambulation (4.5 +/- 6.5 vs 17.8 +/- 5 hours, p <0001) was associated with use of the suture-mediated closure device. The incidence of vascular complications was similar in the overall population (5.7% for suturing device vs 11.3% for compression) or in the interventional patient subset (8.4% for suturing device vs 9.6% for compression). There was a significant reduction in the incidence of vascular complications in the diagnostic procedure subset (4.4% for suturing device vs 12.1% for compression, p <0.05). Thus, the use of a suture-mediated closure device represents a safe alternative to manual compression. Hemostasis and ambulation can be achieved faster with the suturing device than with manual compression, with a potential reduction in access site complications.

[Percutaneous suture of femoral artery access sites after diagnostic heart catheterization and or coronary intervention. Safety and effectiveness of a new arterial suture technic]. / Perkutaner Nahtverschluss von Femoralarterienzugängen nach diagnostischen Herzkatheterisierungen oder Koronarinterventionen. Sicherheit und Effektivität einer neuen Verschlusstechnik arterieller Punktionsstellen.

UNLABELLED: The safety and efficacy of a suture-based closure device designed to achieve hemostasis at the femoral access site post catheterization procedures was compared to manual compression in a 600 patients randomized trial (data available for 590 patients). The patients were randomized to percutaneous vascular surgery (PVS) or manual compression after diagnostic (401 patients) and interventional (189 patients) procedures. Two types of PVS devices were used delivering 1 or 2 sutures at the arterial access site. The overall results as well as the results by procedure type demonstrated a significant reduction in time of hemostasis (7.8 +/- 4.8 min vs 19.6 +/- 13.2 min, p < 0.01) and time to ambulation (4.5 +/- 6.5 hours vs 17.8 +/- 5.0 hours, p < 0.01) with the use of the PVS device. The safety results showed no significant differences in the incidence of vascular complications (5.7% for PVS vs 11.3% for compression) in the overall population or in the interventional patients subset (8.4% for PVS vs 9.6% for compression). However, the PVS device demonstrated a significant reduction in the incidence of vascular complications post diagnostic catheterization procedures (4.4 for PVS vs 12.1% for compression, p < 0.05). The incidence of vascular complications and the time of hemostasis was similar in an American multicenter study (STAND II). CONCLUSION: Percutaneous vascular surgery is a safe and effective method to achieve hemostasis post catheterization procedure providing faster hemostasis and ambulation without increasing the rate of complication.

[Percutaneous suture closure of the femoral artery access after diagnostic heart catheter examination or coronary intervention]. / Perkutaner Nahtverschluss von Femoralarterienzugängen nach diagnostischer Herzkatheteruntersuchung oder Koronarintervention.

BACKGROUND AND OBJECTIVE: Alternative methods to the conventional one of external compression with a pressure bandage over the site of arterial puncture after percutaneous catheter introduction for coronary angiography or transluminal balloon coronary angioplasty have failed to reduce the rate of vascular complications. This study was undertaken to assess the complication rate of a percutaneously introduced suturing device (Techstar, Perclose). PATIENTS AND METHODS: To achieve immediate haemostasis and thus shorten post-interventional immobilisation the technique of percutaneous suturing of the femoral artery was used in 1030 consecutive patients (793 men, 237 women; mean age 58.6 years) without obstructive vascular disease or local vascular complications. RESULTS: Percutaneous suture closure with primary haemostasis was successful after 137 of 153 coronary angioplasties (89.5%) and after 786 of 977 left heart catheterisations (89.6%). Early mobilisation, after at most 4 hours, was possible in 923 patients with successful suture closure (89.6%). The overall complication rate was 0.78%. CONCLUSION: Percutaneous suture repair of the femoral artery after cardiac catheterisation is a safe and effective method to achieve immediate haemostasis. However, controlled studies are needed to demonstrate harmlessness of early mobilisation.

[Cardiomyopathy in progressive muscular dystrophy]. / Kardiomyopathie bei progressiver Muskeldystrophie.

A dilated cardiomyopathy with clear signs of left-ventricular functional abnormalities occurred in a 21-year-old man with known Duchenne's progressive muscular dystrophy. Echocardiography and magnetic resonance imaging delineated the regional disorder of ventricular wall motion and defined its segmental extent. With neither method was it possible to analyse texture with demonstration of differential regional involvement. As a noninvasive method echocardiography is suitable for diagnosing Duchenne's cardiomyopathy and monitoring its progression.

Pharmacokinetic and pharmacodynamic properties of ramipril in patients with congestive heart failure (NYHA III-IV).

To investigate the pharmacokinetics and pharmacodynamics of a new angiotensin converting enzyme (ACE) inhibitor, ramipril (HOE 498), in patients with cardiac insufficiency (NYHA III-IV), we performed an open trial with a follow-up of 10 days. Twenty-seven patients (18 females, 9 males), mean aged 62 years (46-83) with severe heart failure, were included. After a single oral dose of 5 mg ramipril, the plasma and urine levels of ramipril, ramiprilat, ACE plasma activity, standard laboratory values, blood pressure and pulse rate were evaluated. The maximal plasma level of ramipril was 57.0 +/- 26.8 ng/ml after 1.4 h; t1/2 was 2.4 +/- 1.2 h. The peak level of ramiprilat was 27.9 +/- 24 ng/ml after 4.6 h; t1/2 for the active compound was 6 +/- 4.2 h. The total recovery of ramipril and metabolites in urine was on average 39 +/- 17.5% within 96 h. Ninety-five percent inhibition of ACE activity was observed in all patients and 80% inhibition lasted 24 h. Systolic and diastolic blood pressure decreased without changes in heart rate. Five patients had mild side effects: hypotension, diarrhea, and dizziness. In conclusion, in patients with severe heart failure, plasma levels of drug and active metabolite were higher and remained measurable longer, with more sustained inhibition of ACE activity than reported in healthy volunteers. This indicates that titration should start with lower doses (1.25-2.5 mg) and that doses above 5 mg may rarely be necessary.

[Supraventricular tachycardia: therapy with a variable antitachycardia stimulation program]. / Supraventrikuläre Tachykardie: Therapie mit variablem antitachykardem Stimulationsmodus.

Modern, microprocessor-controlled antitachycardia pacemakers are available with extended detection and termination programs for the treatment of supraventricular tachycardias. Using the "InterTach 262-12" we examined a universal antitachycardia pacing mode in the chronic state. Based on the individual electrophysiologic parameters, a defined burst stimulation mode was used for the first intervention and, consecutively, a determined scanning mode. The InterTach device was implanted in 17 patients with a mean age of 50 +/- 15 years: 10 with AV-nodal reentrant tachycardia, 6 with Wolff-Parkinson-White syndrome, 1 with reentrant tachycardia with Mahaim fibers. The mean tachycardia rate was 178 +/- 23/min and the follow-up 10 +/- 4 months. Every 3 months the efficacy of the termination mode was tested by programmed stimulation in supine and upright body position or during physical activity. In these tests, a rate of 95-100% successful terminations was observed. In the chronic state, 26 persistent tachycardias in 11 patients were noted; 21 episodes could be referred to an insufficient tachycardia detection. Only four persistent tachycardias were due to ineffective antitachycardia pacing. The introduction of extended variable termination programs, including consecutive, flexible pacing modes, can be considered as a marked advancement in the antitachycardia pacemaker therapy for supraventricular tachycardias.

[Cyanotic patient with right ventricular dilatation and ventricular arrhythmias]. / Zyanotische Patientin mit rechtsventrikulärer Dilatation und ventrikulären Herzrhythmusstörungen.

Uhl's disease is a very rare congenital anomaly of the heart. Extreme dilatation of the right ventricle is accompanied by virtual absence of the right ventricular myocardium. We report on a 30-year-old woman with ventricular arrhythmias and atrial-septal defect where the diagnosis was made by echocardiography and confirmed by angiocardiography. Diagnostic and therapeutic possibilities are discussed.

[Automatic implantable cardioverter-defibrillator (AICD) and antitachycardia pacemaker (Tachylog 651) in the treatment of ventricular tachyarrhythmias]. / Automatischer implantierbarer Kardioverter-Defibrillator (AICD) und antitachykarder Schrittmacher (Tachylog 651) zur Behandlung ventrikulärer Tachyarrhythmien.

For the electrotherapy of refractory ventricular tachycardia the automatic implantable cardioverter-defibrillator (AICD) and antitachycardia pacemaker are available. The long-term use of antitachycardia pacing is still limited by the potential risk of acceleration to ventricular fibrillation. To combine the advantages of antitachycardia pacing with back-up defibrillation, we evaluated the use of an antitachycardia pacemaker with the automatic defibrillator. The AICD was implanted in 13 patients with a mean age of 62 years (from 46 to 75 years); six of them with recurrent ventricular tachycardia (170 +/- 16 per minute) which could reliably be terminated by overdrive pacing, received also an antitachycardia pacemaker (Tachylog 651). The underlying cardiac disease was coronary heart disease in 11 patients and cardiomyopathy in 2 cases. All patients had survived 1 to 6 cardiac arrests and had not responded to 6 +/- 1.5 antiarrhythmic drugs. For antitachycardia pacing we used burst stimulation with 4 to 6 stimuli and coupling intervals from 260 to 300 ms. During the follow-up period of 12 +/- 2 months, 83% of 744 tachycardias could be terminated by burst stimulation, according to the diagnostic data of the pulse generator. If the pacemaker failed to terminate or in case of acceleration (three patients), the automatic countershock of the AICD (5-42 per patient) restored sinus rhythm. In seven patients with high rate tachycardia, 2 to 69 AICD discharges occurred. No patient died suddenly, but three died due to underlying disease and one because of a pneumonia postoperatively. Future antitachycardia devices should be flexible with regard to detection and termination modes, combining antitachycardia pacing with back-up defibrillation.

[Electrophysiologic effects of diprafenone in supraventricular and ventricular tachycardia]. / Elektrophysiologische Wirkungen von Diprafenon bei supraventrikulärer und ventrikulärer Tachykardie.

The electrophysiologic effects of diprafenone were evaluated in 31 patients (9 X AV nodal reentrant tachycardia, 9 X Wolff-Parkinson-White syndrome, 4 X paroxysmal atrial fibrillation, 10 X recurrent ventricular tachycardia). Electrophysiologic studies were performed before and after intravenous infusion of 1.5 mg/kg body weight diprafenone in a period of 10 minutes. Diprafenone prolonged the mean RR interval during sinus rhythm from 690 +/- 109 ms to 789 +/- 93 ms and the maximal sinus node recovery time from 1081 +/- 216 ms to 1300 +/- 398 ms (p less than 0.001). The effective refractory period of the right atrium increased from 195 +/- 22 ms to 210 +/- 28 ms (p less than 0.01) and of the right ventricle from 220 +/- 20 ms to 235 +/- 20 ms (p less than 0.001). Diprafenone produced a prolongation of the antegrade effective refractory period of the AV node from 260 +/- 35 ms to 294 +/- 39 ms (p less than 0.01) and of the retrograde effective refractory period from 265 +/- 76 ms to 400 +/- 130 ms (p less than 0.001). The effective refractory periods of the Kent bundle increased: antegrade from 299 +/- 45 ms to 413 +/- 133 ms, retrograde from 252 +/- 33 ms to 286 +/- 169 ms (p less than 0.05). Suppression of inducibility was observed in 12 of 17 patients with supraventricular reentrant tachycardia, in 5 of 8 patients with atrial fibrillation and in 7 of 10 patients with recurrent ventricular tachycardia. The rate of supraventricular tachycardias decreased under the influence of the substance.(ABSTRACT TRUNCATED AT 250 WORDS)