Novel X-ray image noise reduction technology reduces patient radiation dose while maintaining image quality in coronary angiography.

AIMS: The consequences of high radiation dose for patient and staff demand constant improvements in X-ray dose reduction technology. This study assessed non-inferiority of image quality and quantified patient dose reduction in interventional cardiology for an anatomy-specific optimised cine acquisition chain combined with advanced real-time image noise reduction algorithms referred to as 'study cine', compared with conventional angiography. METHODS: Fifty patients underwent two coronary angiographic acquisitions: one with advanced image processing and optimised exposure system settings to enable dose reduction (study cine) and one with standard image processing and exposure settings (reference cine). The image sets of 39 patients (18 females, 21 males) were rated by six experienced independent reviewers, blinded to the patient and image characteristics. The image pairs were randomly presented. Overall 85 % of the study cine images were rated as better or equal quality compared with the reference cine (95 % CI 0.81-0.90). The median dose area product per frame decreased from 55 to 26 mGy.cm(2)/frame (53 % reduction, p < 0.001). CONCLUSION: This study demonstrates that the novel X-ray imaging technology provides non-inferior image quality compared with conventional angiographic systems for interventional cardiology with a 53 % patient dose reduction.

Percutaneous revascularization of coronary chronic total occlusion.

Percutaneous coronary intervention for chronic total occlusions is the most challenging and time consuming intervention in Cardiology. It is evolving rapidly, well documented by a success rate that in the hands of specifically trained operators recently increased from about 60% to 90% and longterm patency because of drug eluting stents from 50% to 90%. These results are comparable or even superior to surgical revascularisation. Sophisticated techniques unique to CTO interventions were developed and the need for specific training is emphasised so that the success rate of at least 80% as claimed by the ESC guidelines on myocardial revascularization can be met and patients with CTO who deserve revascularization no longer be denied appropriate treatment.

[The QuIK-Registry of the German Society of Cardiologists in private practice: countrywide and benchmarking quality assurance in invasive cardiology]. / Das QuIK-Register des Bundesverbands Niedergelassener Kardiologen. Flächendeckende vergleichende Qualitätssicherung in der Invasivkardiologie.

QuIK is the German acronym for QUality Assurance in Invasive Cardiology. It describes the continuous project of an electronic data collection in Cardiac catheterization laboratories all over Germany. Mainly members of the German Society of Cardiologists in Private Practice (BNK) participate in this computer based project. Since 1996 data of diagnostic and interventional procedures are collected and send to a registry-center where a regular benchmarking analysis of the results is performed. Part of the project is a yearly auditing process including an on-site visit to the cath lab to guarantee for the reliability of information collected. Since 1996 about one million procedures have been documented.

[5th Report of the German Association of Cardiologists in Private Practice (BNK) on Quality Assurance in Cardiac Catheterization and Coronary Intervention 2003-2005]. / 5. Bericht des Bundesverbandes Niedergelassener Kardiologen zur Qualitätssicherung in der diagnostischen und therapeutischen Invasivkardiologie 2003-2005.

On behalf of the German Association of Cardiologists in Private Practice (BNK) the Steering Committee of the QuIK Registry reports on the results of the voluntary quality assurance in invasive cardiology in 2003-2005 and compares it to other data collections. In 2005 more than 70% of diagnostic (LHK) and 78% of therapeutic (PCI) cardiac catheterization procedures in private practice were entered into the registry. Altogether 229,462 LHK and 64,818 PCI were documented over the 3 years. In the reported period age of patients, percentage of acute coronary syndromes and three-vessel coronary artery disease increased in LHK as well as in PCI while consumption of contrast media and fluoroscopy time decreased. By implemented possibility of follow-up, a high rate of external auditing (monitoring) and certification QuIK remains a worldwide unique quality assurance project in cardiology. On a stable data basis over 10 years the QuIK Registry enables the implementation of quality indicators for future quality assurance purposes.

Percutaneous in situ coronary venous arterialization: report of the first human catheter-based coronary artery bypass.

Diffuse coronary artery disease is frequently untreatable by coronary artery bypass or angioplasty. Many such "no-option" patients have been subjects for trials of angiogenesis using growth factor manipulation or laser injury. We think these novel revascularization strategies are limited by insufficient inflow to putative areas of new microvasculature and thus seek a more mechanical solution. We report the use of a catheter-based system for arterializing the adjacent anterior cardiac vein in a patient with chronic total occlusion of the left anterior descending coronary artery. A composite catheter system (phased-array ultrasound imaging system mounted on a catheter with extendable nitinol needle) was used to deliver an exchange-length intracoronary guidewire from the proximal left anterior descending coronary artery into the parallel anterior interventricular vein. Using standard angioplasty techniques, a fistula was then constructed from the proximal artery to the coronary vein using a self-expanding connector. The proximal vein was blocked with a novel self-expanding "blocker," thus precluding "steal" through the coronary sinus and forcing retroperfusion of the anterior wall. The procedure was completed without complication, and a follow-up angiogram at 3 months confirmed continued patency of the arteriovenous connection. This patient, who had severe angina before the procedure, has been asymptomatic for 12 months. Percutaneous in situ venous arterialization may be an effective therapy for diffuse, "untreatable" coronary disease by supplying a robust inflow of arterialized blood via retroperfusion to severely ischemic myocardium.

[Carotid percutaneous transluminal angioplasty in cardiological patients with increased surgical risk]. / Carotis-PTA bei kardiologischen Patienten mit erhöhtem Operationsrisiko.

UNLABELLED: Carotid angioplasty is a revascularisation procedure introduced more than 20 years ago and that is still not widely accepted. Most institutions perform this intervention only under a study protocoll or in patients with high risk for carotid surgery. We performed angioplasty of the extracranial internal carotid artery in 50 patients with increased risk for surgery: 43 men, 7 women, 19 older than 75 years, 42 with significant coronary artery disease and 25 prior to CABG. Eight patients presented with an LVEF < 40%, 13 were neurologically unstable, 6 had a recurrence after endarterectomy and 1 patient had a lesion induced by radiotherapy. After predilatation with a 3.5 mm balloon via 8 F guiding catheter we implanted 21 JJ biliary stents, 25 Jostent Carotid, 2 Wallstents und 4 coronary stents. RESULTS: 47/50 patients were dilated successfully with a reduction of the stenosis from 82 +/- 12% to 6 +/- 8%. Three patient experienced a severe acute complication: 1 severe intracerebral bleeding after 5 hours, most likely due to abciximab, and 2 minor cerebral strokes. After 6 months 1 patient had died after CABG, 1 patient experienced a TIA and another developed restenosis (2.4%). CONCLUSION: Carotid angioplasty with stenting is a valuable alternative to Carotis-TEA or medical therapy, especially in patients with significant comorbidity, who present with increased risk for vascular surgery.

Audit and quality control in angioplasty in Europe: procedural results of the AQUA Study 1997: assessment of 250 randomly selected coronary interventions performed in 25 centres of five European countries. AQUA Study Group, Nucleus Clinical Issues, Working Group Coronary Circulation, of the European Society of Cardiology.

AIMS: Percutaneous transluminal coronary angioplasty (PTCA) has become the most widely used major intervention in western medicine. However, there is disparate use of this technique among different European countries and the U.S.A. In an attempt at quality assurance, the working group Coronary Circulation of the European Society of Cardiology has carried out a study on appropriateness, necessity, and performance of PTCA in Europe. The present paper reports on the procedural results of this survey. METHODS: In a multicentre case-control study in Europe, 750 patients (544 men, 206 women) with documented vascular disease of the From the countries participating in the European Registry of Coronary Intervention, the three countries with the highest absolute PTCA volume (Germany, France, and the United Kingdom) and two randomly selected countries (Belgium and Italy) were chosen for investigation. In these countries, five centres were selected at random according to the following criteria: one centre with >1000, three centres with 300-1000, and one centre with <300 procedures per year. In each of these, 10 cases from the first half of 1997 were randomly identified and all pertinent documentation was collected. RESULTS: In 250 cases, 325 stenoses were addressed as target lesions. Single vessel disease was present in 41%. History included stable angina in 49%, unstable angina in 32%, atypical chest pain in 6%, no anginal pain in 12%, and acute/subacute myocardial infarction in 13%. The percentage of patients with either positive stress test and/or unstable angina, acute/subacute infarction, previous infarction (within 6 months) or coronary revascularization amounted to 98%. Single vessel intervention accounted for 90%. In 41% balloon-only angioplasty was performed and in 54% at least one stent was implanted with considerable variation among countries. The use of other new devices amounted to only 3%. In 92%, the operators documented a successful procedure. Major complications (myocardial infarction, emergency bypass surgery, or death) were found in 4.8%. CONCLUSIONS: Based on scrutinized hospital and operator data, the present study revealed a satisfactorily high percentage of justifiable indications, an adequate procedural success rate, and an acceptably low complication rate. Further analysis by an expert panel will address appropriateness, necessity, and procedural performance of the individual cases.

A novel stent delivery catheter: the Intella Trinity balloon.

The Trinity catheter is a novel multiballoon device designed to facilitate stent delivery by providing for predilatation, stent deployment, and further expansion on a single shaft. The device was tested extensively in a canine model with a variety of stents before being used in a limited human feasibility trial in Europe. A description of the device and its initial human application is presented.

Transvenous closure of patent ductus arteriosus with Ivalon plugs. Multicenter experience with a new technique.

RATIONALE AND OBJECTIVE: The authors assess the clinical efficacy of transvenous closure of patent ductus arteriosus (PDA) with a new plug consisting of Ivalon foam and a platinum/iridium frame with four aortic and two pulmonary nitinol struts. The most widely used devices for transcatheter treatment of PDA (Porstmann plug, Rashkind umbrella, Botallo occluder, coils) have specific limitations inherent to their design (e.g., transarterial approach, residual shunts, limited retrieval). METHODS: Between 1994 and 1997, PDA closure was attempted in 33 children and 67 adolescents and adults in 7 clinical centers; PDA diameter was 2 to 11 mm. Plug diameter was 6 to 20 mm, and 8 to 16 F venous sheaths were used for insertion. RESULTS: Placement was successful in 98% (with a single plug in 88%, and a second or third plug in 10%) and unsuccessful in 2%. Plugs were retrieved after malpositioning in 12 of 12 patients and after pulmonary embolization in 2 of 3 patients. One patient underwent surgery for removal of an embolized plug. Complete PDA closure was proved by aortography and color Doppler echocardiography in 85% (40 of 43 patients with a PDA 2-3.9 mm, 30 of 36 patients with a PDA 4-5.9 mm, and 15 of 21 patients with a PDA 6-11 mm). During a median follow-up interval of 16 months, there were no complications (infection, hemolysis, fracture, embolization). CONCLUSION: The new plug device can be used successfully in patients with a PDA diameter up to 11 mm. Further investigations are underway to determine the definite clinical value of this technique.

[From surgical to interventional standby?]. / Vom chirurgischen zum interventionellen Stand-by?

UNLABELLED: Life threatening Q-infarction because of bypassgraft occlusion may occurr in 5-8% of the patients during the first days after CABG, and most patients are treated by immediate reoperation. This treatment may however be delayed because operating rooms might not be available immediately. We prospectively studied the feasability and safety of immediate coronary angiography and PTCA, if appropriate, in patients with severe ischemic in-hospital complications after CABG. From January till December 1995 1263 patients had CABG: mean age 64.9 +/- 10 y, 24% female, 7.1% emergencies (CABG < 24 h after coronary angiography). A 24 hours interventional standby was provided to perform immediate catheterization and PTCA in patients with signs of evolving myocardial infarction after CABG (ST-elevation in > or = 2 leads and hemodynamic compromise or new LV hypocinesia in the transoesophageal echocardiogramm). RESULTS: 3/1263 patients had immediate reoperation without angiography. 55/1263 patients were catheterized, all within 1 hour after the onset of Stelevation. 14/1263 had normal grafts and complete revascularization. Their ischemia was either transient (spasm) or the ECG was misinterpreted (pericarditis). Catheterization caused no severe complications. 2 patients had major bleeding at the puncture site. 41 patients presented with envolving Q-MI: 1 patient had immediate reoperation, 29 patients received immediate PTCA and 11 patients were treated medically. 8/29 PTCA-patients were in cardiogenic shock. We dilated 4 IMA-anastomoses, 3 distal veingraft anastomoses, 18 native vessels with occluded veingrafts and 4 native vessels, having not been grafted. Angiographic success was achieved in 20/29 (69%), clinical success in 65% (residual stenosis < 50%, no severe complications during hospital stay). 2 patients died during the first 30 days (none due to the PTCA procedure or PTCA-related delay of reoperation), Q-MI occurred in 2/29, NonQ-MI in 7/29, reoperation appeared necessary in 4/29, no bleeding complications were noticed. CONCLUSIONS: Immediate coronary angiography after CABG is feasable and safe. Salvage-PTCA early after CABG is an alternative treatment in patients with evolving Q-MI. Interventional standby might therefore be useful for institutions with a busy cardiac surgical program.

[Balloon angioplasty of stent restenosis: early and late results of first and second PTCA in focal and diffuse stenosis]. / Ballonangioplastie der Stent-Restenose: Früh- und Spätergebnisse der ersten und zweiten PTCA bei fokaler und diffuser Stenosierung.

UNLABELLED: From January 1996 until February 1997 6,376 patients were treated by our group with PTCA and 3,859 (60.5%) received one or several stents. An angiographic followup was achieved in 63% of the patients with 1,267 experiencing restenosis (32.8%). Of those being treated with re-PTCA 302 were randomly selected for further analysis. In-stent-restenosis was treated with rotablator in 8 patients (2.7%), with eximer laser in 21 (7.0%) and with another stent in 48 patients (15.9%). 225 patients (74.4%) of this subselection were treated with balloon-angioplasty only. Mean patient age was 63 +/- 10.2 years, 401 stents had been implanted (42.5% Wiktor, 13.7% Jomed Sito, 12.3% ACS Multlink, 9.5% GR II, and some others), the number of stents per patient was 1.68, mean stent length 28.5 mm, mean stent diameter 3.01 +/- 0.3 mm, the time since implantation 142 +/- 76 days. The recurrence appeared as restenosis in 199 patients (88.4%) and as a chronic stent occlusion in 26 (11.6%). In-stent-restenosis was discovered in 94.7% within the stent and was of focal appearance (restenosic lesion of < or = 5 mm) in 28.5% and diffuse (> 5 mm) in 71.5%. Balloondilatation (balloon:artery = 1:1; maximal pressure 11.7 +/- 3.3 bar) was successfull in 98% of the stenotic lesions and in 18/26 of the chronically occluded stents (definition of success: residual stenosis < 50%, no major complications). The stenosis decreased from 82.2% to 20.5% (12.8% in focally stenosed vessels and 23.6% in diffuse restenosis). Complications were death in 0.9%, Q-MI in 0% CABG in 0.9%, Non-Q-MI in 2.4%, subacute stent thrombosis in 0.5% and groin bleeding in 1.8%. A clinical follow up after 151.7 +/- 87.7 days was achieved in 98.6% and an angiographic follow up in 69.1% of the patients: 1.9% had died (2/4 due to noncardiac disease), no MI, 6.2% CABG and 31% PTCA (TLR 37.2%). A second restenosis within the stents ocurred in 27.9% of those with focal disease and in 44.3% of those with diffuse in stent restenosis. CONCLUSIONS: Restenosis within stents may occurr in about 30% of unselected patients. In 2/3 these stenoses appear diffuse and in 10% they appear as chronic occlusions. Re-PTCA with balloons is rather simple with a high success rate (even in chronic stent occlusions) and a low complication rate. The incidence of a second restenosis is acceptably high in focal lesions but appears unacceptable in patients with diffuse in-stent-restenosis. Thus the indication for stenting should be restricted to patients with clear cut advantage over balloon-angioplasty alone, e.g. threatening closure, chronic occlusion, old savenous veingraft and proximal LAD stenosis.

Initial results of laser-based percutaneous myocardial revascularization for angina pectoris.

Results of a 30-patient pilot study of a recently developed percutaneous myocardial revascularization approach are described. The feasibility and positive safety profile of percutaneous myocardial revascularization are clearly demonstrated, with no mortality associated with the treatment or in the immediate post-treatment period and an incidence of only 1 major complication.

[First annual report of practitioners of interventional cardiology in private practice in Germany. Results of procedures of left heart catheterization and coronary interventions in the year 1996]. / Erster Jahresbericht niedergelassener Invasivkardiologen in Deutschland. Ergebnisse für diagnostische Linksherzkatheteruntersuchungen und Koronarinterventionen 1996.

The German Society for Cardiac Angiography and Interventions in Private Practice has started a registry of cardiac procedures since 1996 in order to establish a standard for performance. Although quality management for the cath lab makes sense and is also legally required, there is no generally recommended infrastructure for quality assurance existing in Germany at this time. Therefore, the German Society of Cardiologists in Private Practice (BNK) initiated a project in 1994 to develop a computer program for paperless documentation of diagnostic cardiac catheterizations and coronary interventions (PTCA) using a minimal data set. In 1996, 8 private associated groups participated in this project. The (anonymous) analysis of 10,316 diagnostic cardiac catheterizations and 2597 PTCA yielded the following results: In 95% of the patients, diagnostic cardiac catheterization was performed using the femoral and in 5% the brachial/radial approach. The mean volume of administered contrast medium was 164 +/- 138 ml/patient. The mean LV-EF was greater than 50% in 58.4% of the patients and between 30% and 50% in 10.1%. Coronary artery disease was diagnosed in 69.6% of the patients and valvular/congenital heart disease in 8.5%. In 18.4% of the patients undergoing diagnostic cardiac catheterizations no significant heart disease was identified. Mortality in the cath lab as well as the rate of cerebral insults was 0.05%. In 22.9% and 19% of the patients PTCA and cardiac surgery respectively was recommended. In patients undergoing PTCA, stable angina was present in 74.4% and unstable angina in 13.1%. Of the total number of PTCA procedures, 5.8% were performed in the setting of acute myocardial infarction. The PTCA lesion success rate was 96%, the mean diameter stenosis was 81% pre and 6% post-intervention. The mortality rate at 1 month post-PTCA was 0.4%, and myocardial infarction 1.0%. An acute occlusion occurred in 1.3% of the PTCA patients; 0.6% had to be transferred for emergency bypass surgery. None of the cath labs had on-site surgery. In comparison to other registries, our data show some similarities but also some different trends. Thus, our newly developed software proved to be reliable, fast and easy to use. Participating centers receive immediate feedback regarding their position within the whole group.

Direct coronary stenting without predilatation: a new therapeutic approach with a special balloon catheter design.

Coronary stenting is the primary therapeutic option for many coronary lesions, after the risk of subacute stent thrombosis and bleeding complications has been reduced by antithrombotic regimens and improved stent expansion. It would be desirable to shorten the procedure and the duration of ischemia, and to reduce the risk of ischemic complications during balloon inflation by implanting the stent without previous dilatation of the lesion. This is not possible with the presently available stent delivery systems. This new therapeutic concept was tested with a specially designed balloon catheter, on which slotted-tube stents can be fixed between two conical radiopaque markers. Sixty-one patients eligible for angioplasty underwent direct stent implantation without predilatation. Four procedures were performed for acute myocardial infarction, and two as high-risk PTCA. Single slotted-tube stents (Palmaz-Schatz, NIR, or JOStent) of 14-16-mm length were mounted between the conical radiopaque markers of a special balloon which provided a fixation for the crimped stent. The direct implantation was successful in 80% of all patients, while in 10% the stent could be deployed after predilatation of the lesion. In 10% of lesions a stent could not be implanted with this and any other delivery system. When patients with successful direct stenting were compared with those with indirect (after predilatation) or unsuccessful stent deployment, the presence of angiographically visible calcification was higher in the unsuccessful cases (75% vs. 19%; P < 0.01), and the patients were older (72+/-8 vs. 61+/-12 years; P < 0.01). Radiation exposure time was only 8.7+/-5.1 min as compared with 12.6+/-7.6 min in conventional stent procedures with predilatation (P < 0.05). The number of balloons used per lesion was also lower than with conventional stenting. Stent dislocation was observed in 5%, and no embolization occurred. The new therapeutic approach of direct stenting without predilatation proved to be a safe and successful procedure in this initial series of coronary angioplasties. When calcified coronary lesions are avoided, it provides a way to rationalize stent implantation with shorter radiation exposure times, fewer balloons, and the potential advantage of fewer ischemic complications as no balloon predilatation is required.

Recanalization of total coronary occlusions using a laser guidewire (the European TOTAL Surveillance Study).

The success rates of coronary angioplasty for the treatment of chronic total occlusions are less favorable than for coronary stenosis. Therefore, a new laser guidewire (LW) was designed to facilitate the crossing of chronic total occlusions. We report on the results of a European multicenter surveillance study, evaluating the laser guidewire performance. Between May 1994 and July 1996, 345 patients (age 59 +/- 10 years, 291 men) with chronic total occlusions were enrolled in 28 European centers. The median age of occlusion was 29 weeks (range 2 to 884), the occlusion length 19 +/- 10 mm. LW recanalization was successful in 205 patients (59%/). LW perforation occurred in 73 patients (21%), with hemodynamic consequences in 4 (1%). There were no deaths, emergency coronary artery bypass graft surgery, or Q-wave myocardial infarctions. In a multivariate regression analysis an occlusion age of <40 weeks (p = 0.001, RR = 1.34) and an occlusion length <30 mm (p = 0.01, RR = 1.59) were independent predictors of success. Results indicate that the LW is an effective and safe tool in the treatment of chronic total occlusion refractory to conventional guidewires.

Randomized comparison of angioplasty of complex coronary lesions at a single center. Excimer Laser, Rotational Atherectomy, and Balloon Angioplasty Comparison (ERBAC) Study.

BACKGROUND: The purpose of this study was to test whether coronary revascularization with ablation of either excimer laser or rotational atherectomy can improve the initial angiographic and clinical outcomes compared with dilatation (balloon angioplasty) alone. METHODS AND RESULTS: At a single center, a total of 685 patients with symptomatic coronary disease warranting elective percutaneous revascularization for a complex lesion were randomly assigned to balloon angioplasty (n = 222), excimer laser angioplasty (n = 232), or rotational atherectomy (n = 231). The primary end point was procedural success (diameter stenosis < 50%, absence of death, Q-wave myocardial infarction, or coronary artery bypass surgery). The patients who underwent rotational atherectomy had a higher rate of procedural success than those who underwent excimer laser angioplasty or conventional balloon angioplasty (89% versus 77% and 80%, P = .0019), but no difference was observed in major in-hospital complications (3.2% versus 4.3% versus 3.1%, P = .71). At the 6-month follow-up, revascularization of the original target lesion was performed more frequently in the rotational atherectomy group (42.4%) and the excimer laser group (46.0%) than in the angioplasty group (31.9%, P = .013). CONCLUSIONS: Procedural success of rotational atherectomy is superior to laser angioplasty and balloon angioplasty; however, it does not result in better late outcomes. The role of plaque debulking before balloon dilatation in percutaneous coronary revascularization remains to be fully defined.

New double wire technique to stent ostial lesions.

We describe a new fast technique to precisely deploy J&J Stents in ostial lesions using two guide wires. The second guide wire is inserted through the proximal stent strut and simultaneously advanced together with the stent on the balloon serving as a position marker that guides stent placement. This technique has been applied in 10 cases with 100% success and with no major complications.

[Thoracic radiography as routine within cardiological diagnosis?]. / Röntgen-Thorax-Untersuchung als Routine im Rahmen einer kardiologischen Diagnostik?

OBJECTIVE: As chest radiography is still frequently used routinely in patients suspected of heart disease, the study was undertaken prospectively to assess its value in view of the potentials of modern noninvasive methods. PATIENTS AND METHODS: History, physical examination, electrocardiography, ergometry, echocardiography and colour Doppler echocardiography as well as chest radiography were undertaken in 201 consecutive patients (113 men, 88 women, age 60 [3-88] years) with known or suspected cardiac valvular defects or heart failure. Subsequently invasive investigations were performed in 92 of these patients. RESULTS: The value of chest radiography depended on the nature and severity of the particular cardiac disease. The diagnosis was established without chest radiography in all defects (40 patients) of grade III or IV (New York Heart Association) or NYHA class III or IV heart failure (30 patients). Chest radiography provided no additional prognostic or therapeutic information. CONCLUSION: These data indicate that routine chest radiography is of no value as a screening method in patients with chronic heart failure or cardiac defects, except in a few clearly defined specific circumstances.