Hubertus von Korn

Interventional Therapy of Bifurcation Lesions A TIMI Flow-Guided Concept to Treat Side Branches in Bifurcation Lesions—A Prospective Randomized Clinical Study (Thueringer Bifurcation Study, THUEBIS Study as Pilot Trial)

Background—Treatment of bifurcations is a complex problem. The clinical value of treating side branches is an unsolved problem in the field of interventional cardiology. Methods and Results—We initiated a prospective randomized controlled trial. One hundred and ten patients with bifurcations were randomly assigned to 2 arms: Stenting of the main branch (MB, Taxus-stent, paclitaxel-eluting stents) and mandatory side branch (SB) percutaneous coronary intervention (PCI; kissing balloons) with provisional SB stenting (therapy A), or stenting of the MB (paclitaxel-eluting stents) with provisional SB-PCI only when the SB had a thrombolysis in myocardial infarction flow <2 (therapy B). The primary end point was target lesion revascularization. The mean ages were 66.8 years (A) versus 65.1 years (B, P=0.4), 71.4% (A) versus 77.8% were men (P=0.4), patients with diabetes were present in 25.0% versus 25.9% (P=0.9). The MB was left anterior descending artery in 80.4% versus 81.5% (A versus B, P=0.9). The SB-PCI and kissing balloon-PCI were performed according to the study protocol in 82.1%/73.2% versus 16.7%/13.0% (P<0.05 for both), while changing of the intended therapy was necessary in 17.9% versus 16.7% (A versus B, P=0.9). A final thrombolysis in myocardial infarction flow 3 (MB) was reached in all patients (groups A and B), final thrombolysis in myocardial infarction flow 3 (SB) was observed in 96.4% versus 88.9% (A versus B, P=0.3). Radiation time (min) and contrast medium (mL) were 14.2/210 (group A) versus 7.8/151.6 (group B; P for both <0.05). Six month – follow up: major adverse cardiac events was 23.2% (A) versus 24.1% (B, P=0.9), target lesion revascularization was 17.9% (A) versus 14.8% (B, P=0.7), and late lumen loss (MB) was 0.2 mm (A) versus 0.3 mm (B, P=0.5). In group B, no PCI of the SB was done during follow up. Conclusion—A simple strategy using paclitaxel-eluting stents with only provisional SB-PCI may be of equal value to a more complex strategy with mandatory SB-PCI. Clinical Trial Registration—URL: http://www.controlled.trials.com. Unique identifier: ISRCTN22637771.

Interventional Therapy of Bifurcation Lesions

Background—Treatment of bifurcations is a complex problem. The clinical value of treating side branches is an unsolved problem in the field of interventional cardiology. Methods and Results—We initiated a prospective randomized controlled trial. One hundred and ten patients with bifurcations were randomly assigned to 2 arms: Stenting of the main branch (MB, Taxus-stent, paclitaxel-eluting stents) and mandatory side branch (SB) percutaneous coronary intervention (PCI; kissing balloons) with provisional SB stenting (therapy A), or stenting of the MB (paclitaxel-eluting stents) with provisional SB-PCI only when the SB had a thrombolysis in myocardial infarction flow <2 (therapy B). The primary end point was target lesion revascularization. The mean ages were 66.8 years (A) versus 65.1 years (B, P=0.4), 71.4% (A) versus 77.8% were men (P=0.4), patients with diabetes were present in 25.0% versus 25.9% (P=0.9). The MB was left anterior descending artery in 80.4% versus 81.5% (A versus B, P=0.9). The SB-PCI and kissing balloon-PCI were performed according to the study protocol in 82.1%/73.2% versus 16.7%/13.0% (P<0.05 for both), while changing of the intended therapy was necessary in 17.9% versus 16.7% (A versus B, P=0.9). A final thrombolysis in myocardial infarction flow 3 (MB) was reached in all patients (groups A and B), final thrombolysis in myocardial infarction flow 3 (SB) was observed in 96.4% versus 88.9% (A versus B, P=0.3). Radiation time (min) and contrast medium (mL) were 14.2/210 (group A) versus 7.8/151.6 (group B; P for both <0.05). Six month – follow up: major adverse cardiac events was 23.2% (A) versus 24.1% (B, P=0.9), target lesion revascularization was 17.9% (A) versus 14.8% (B, P=0.7), and late lumen loss (MB) was 0.2 mm (A) versus 0.3 mm (B, P=0.5). In group B, no PCI of the SB was done during follow up. Conclusion—A simple strategy using paclitaxel-eluting stents with only provisional SB-PCI may be of equal value to a more complex strategy with mandatory SB-PCI. Clinical Trial Registration—URL: http://www.controlled.trials.com. Unique identifier: ISRCTN22637771.

Prevalence and Outcome of Congenital Left Ventricular Aneurysms and Diverticula in an Adult Population

Objectives: We sought to investigate the prevalence and clinical outcome of congenital left ventricular aneurysms (LVAs) and diverticula (LVD) in a large adult population. Methods: We retrospectively studied the left ventricular angiograms of 12,271 consecutive patients undergoing cardiac catheterization at our institution and analyzed the medical records of the patients. Results: The overall prevalence of LVA/LVD was 0.76% (94 patients): there were 42 patients with LVA (0.34%) and 52 patients with LVD (0.42%). Men were more likely to have LVA (62 vs. 38%), and women were more likely to have LVD (75 vs. 25%; p = 0.001 for both). The mean time of follow-up was 56 ± 6 months and was focused on clinical events, rehospitalization and survival. Mortality was 6% with no cardiac death. Patients with LVD were significantly more likely to have embolic events (p = 0.04). Patients with LVA and LVD were more likely to have rhythm disturbances compared with controls (p = 0.01 for both). Incidence of syncope was not different in both groups (p = 0.4 and 0.12, respectively). There was no reported incidence of rupture. Conclusion: This large single-center study suggests that the prevalence of LVA/LVD in adults is up to 20-fold higher than previously reported. One third of the affected patients in our series had nonfatal cardiovascular events during follow-up, with a predominance of embolic events in the LVD group.

Incidence and outcome of femoral vascular complications among 18,165 patients undergoing cardiac catheterisation

BACKGROUND Arteriovenous fistulas (AVF) and arterial pseudoaneurysms (PSA) are potentially harmful complications of diagnostic and interventional cardiac catheterisation. Incidence, risk factors and clinical outcome are not well defined yet, although important for stratification and treatment. METHODS A total of 18,165 consecutive patients undergoing cardiac catheterisation were enrolled in our prospective registry. For the diagnosis of AVF and PSA a clinical examination was performed in every patient followed by a Duplex examination in case of clinical suspicion of AVF/PSA. The impact of the following risk factors was assessed: age, body mass index, puncture of left vs. right groin, gender, hypertension, sheath size, peripheral artery disease, coumadin therapy, glycoprotein IIb/IIIa-inhibitors, pre-treatment with thrombolytics, and emergency procedures. RESULTS Within 3 years a total of 334 complications were found (1.8%). The incidence of AVF and PSA was 0.6% (n = 107) and 1.2% (n = 227), respectively. The following significant independent risk factors were identified: arterial hypertension (odds ratio [OR]) = 1.86, female gender (OR = 1.65), and emergency procedures (OR = 2.13). During follow-up (mean 48 +/- 10 months) only 11% of all AVF underwent operative repair due to symptoms. All PSA could be treated successfully either by manual compression, thrombin injection, or surgery. The overall mortality was 0.8%. CONCLUSION Almost 2% of patients undergoing cardiac catheterisation acquire femoral AVF or PSA, for which patient- or procedure-related risk factors could be identified. Most of AVF and PSA could be managed conservatively or without any treatment, the overall mortality is low.

Direct coronary stenting versus predilatation followed by stent placement

Direct stenting without antecedent dilatation may reduce procedural time, costs, and radiation exposure, and may result in less vessel injury. The purpose of this investigation was to compare immediate and long-term clinical and angiographic outcomes of direct stenting with stent placement after initial balloon dilation. Three hundred thirty-five symptomatic patients with single or multiple coronary lesions (diameter reduction 60% to 95%) of < or =30 mm length and with a vessel diameter of 2.5 to 4.0 mm were randomized either to direct stenting (group A, n = 171) or stenting after predilation (group B, n = 164). Patients with vessels with excessive calcification, severe proximal tortuosity, or occlusion were excluded. All patients were asked to return for routine repeat angiography at 6 months, irrespective of symptoms. Feasibility of direct stenting was 95% in group A, with 5% requiring crossover to predilation. Successful stent placement after predilation was performed in all 164 patients in group B. Direct stenting was associated with less procedural duration (group A 42.1 +/- 18.7 minutes vs group B 51.5 +/- 23.8 minutes, p = 0.004), radiation exposure time (group A 10.3 +/- 7.7 minutes vs group B 12.5 +/- 6.4 minutes, p = 0.002), amount of contrast dye used (group A 163 +/- 69 ml vs group B 197 +/- 84 ml, p <0.0001), and lower procedural costs (group A 845 +/- 167 vs group B 1,064 +/- 175, p <0.0001). Immediate angiographic results and in-hospital clinical outcomes (death, Q-wave myocardial infarction, repeat revascularization) were not significantly different between both strategies. However, at 6-month follow-up, direct stenting was associated with a lower angiographic restenosis (group A 20% vs group B 31%, p = 0.048) and target lesion revascularization rates (group A 18% vs group B 28%; p = 0.03). This study demonstrates the feasibility, safety, and outcomes of direct stenting in eligible coronary lesions. In appropriately selected cases, direct stenting has a lower rate of angiographic restenosis up to 6 months after the procedure, resulting in fewer coronary reinterventions compared with the conventional strategy of stenting with antecedent dilatation.

Characteristics and outcome of congenital left ventricular aneurysm and diverticulum: Analysis of 809 cases published since 1816

BACKGROUND Congenital left ventricular aneurysm (LVA) or diverticulum (LVD) is rare cardiac anomalies. We aimed to analyse the clinical characteristics and outcome in all ever published patients. METHODS MEDLINE, Web of science, Google and EMBASE, and reference lists of relevant articles were searched for publications reporting on LVA or LVD patients. RESULTS We identified 809 patients published since 1816 [354 (49.1%) LVA, 453 (50.6%) LVD, 2 (0.3%) both]. Mean age at diagnosis was 34.1±27 (LVA) and 29.7±27.6years (LVD; p=0.05). 48.9% were male. LVA was larger (38.7±22.5mm versus 31.4±21.2mm; p=0.002) and frequently found in submitral location (33% versus 4.9%; p<0.001), LVD was frequently located at the LV-apex (61.2% versus 28.7%; p<0.001). LVD was often associated with cardiac (34.2% versus 11%; p<0.001) or extracardiac anomalies (32.7% versus 3%; p<0.001). LVA patients presented more frequently with ventricular tachycardia/fibrillation (18.1% versus 13.1%; p=0.01), the incidences of rupture (4% versus 4.5%; p=0.9), syncope (8.3% versus 5.1%; p=0.1), and embolic events (4.9% versus 3.6%; p=0.4) at presentation were not different between LVA and LVD. Mean follow-up was 56.3±43months. Cardiac death occurred more frequently in the LVA group (11.5% versus 5.0%; p=0.05) at a median age of 0.8 [LVA] and 2.5 [LVD] years. The leading cause of cardiac death was congestive heart failure in the LVA-group (50.0% versus 0.0%; p=0.01), and rupture in the LVD-group (75.0% versus 27.3%; p=0.04). CONCLUSIONS LVA and LVD are distinct congenital anomalies with different clinical and morphological characteristics. The prognosis of LVA is significantly worse during long-term follow-up.

Tako-Tsubo-Like Cardiomyopathy: Specific ECG Findings, Characterization and Clinical Findings in a European Single Center

Objectives: A newly discovered heart syndrome mimicking acute coronary syndrome has been termed ‘Tako-Tsubo cardiomyopathy’ (TTC). Differentiation from acute myocardial infarction using the ECG is an important issue in clinical practice. Methods: We retrospectively analyzed patients admitted for cardiac catheterization between September 2003 and September 2006. Results: From 26,593 cardiac catheterization procedures, we identified 21 patients with suggested TTC (0.08%). Trigger mechanisms were present in 38.1%; all patients had elevated troponin levels (mean 3.9 ng/ml). Median age was 68.4 years; 90.5% were female. Hypertension was seen in 85.7% and atrial fibrillation in 19.1%. Specific ECG findings related to a TTC are: a mild elevation of the ST segment arising from the S curve of the QRS complex, where the maximum ST segment elevation at the basis of the T wave is <1.5 mm, T-wave inversion, absence of ST segment depression and a summated amplitude of the S curve in V1 plus R in V6 <1.5 mV. An intraventricular gradient was seen in 9.5%; coronary atherosclerosis was detected in 57.1%. Follow-Up Data: Mean follow-up was 13.2 months. 47.6% were free from angina or dyspnea, most of the patients received β-blockers/ACE inhibitors (76.2%). One patient had a sudden cardiac death (4.8%), 1 patient became an implantable cardioverter-defibrillator primarily due to resuscitation. Conclusion: TTC is a rare syndrome mimicking acute coronary syndrome that shows a specific ECG pattern and does not appear to be an unambiguously benign disease.

Export aspiration system in patients with acute coronary syndrome and visible thrombus provides no substantial benefit.

A visible thrombus remains a risk factor during percutaneous coronary intervention (PCI).

Percutaneous thrombin injection for treatment of iatrogenic femoral artery pseudoaneurysms: a case for caution.

The case of a patient who developed a femoral artery pseudoaneurysm following cardiac catheterization is described. After 2 failed attempts of ultrasound-guided compression repair, the patient underwent percutaneous thrombin injection with, beside of complete closure of the pseudoaneurysm, a severe limb ischemia due to distal thrombin migration with consecutive clot formation finally resulting in thigh amputation of the affected leg. Indications, advantages, and disadvantages of various options for the treatment of iatrogenic femoral artery pseudoaneurysms (vascular surgery, ultrasound-guided compression, percutaneous thrombin injection, and other nonsurgical treatment modalities), as well as risk factors for distal migration of liquid thrombin after percutaneous injection, are discussed in this report.

Initial experience with the Endicor X-sizer thrombectomy device in patients with ST segment elevation myocardial infarction

In der vorliegenden Pilotstudie wurden 16 Patienten mit akutem ST-Hebungsmyokardinfarkt (AMI) untersucht. Alle Patienten hatten zum Zeitpunkt der Koronarangiographie ein verschlossenes Koronargefäß (TIMI 0 Fluss). Es war die Absicht, bei allen Patienten eine Thrombektomie (mit dem Endicor X-Sizer) anstelle einer Ballonangioplastie vor der geplanten Stentimplantation durchzuführen. Bei 15 Patienten war die Thrombektomie erfolgreich und resultierte in einem TIMI 3 Fluss. Nach erfolgreicher Stentimplantation blieb bei allen 15 Patienten der TIMI 3 Fluss erhalten. Ein 12 Kanal-EKG wurde unmittelbar vor und nach der Koronarintervention aufgezeichnet. Das Ausmaß der ST-Streckenhebung wurde aus der Summe von acht Ableitungen für anteriore Infarkte und aus fünf Ableitungen für inferiore Infarkte ermittelt. Eine EKG-Analyse war bei 13 Patienten möglich (2 Patienten entwickelten einen Schenkelblock). Bei allen 13 Patienten fand sich nach der Intervention eine >50% Reduktion der ST-Strecke und bei 11 Patienten sogar eine >70% Reduktion. Periprozedurale Komplikationen waren niedrig (1 Koronardissektion nach Thrombektomie) und es traten keine kardialen Ereignisse innerhalb von 30 Tagen auf. Die Thrombusextraktion könnte eine Alternative zur Ballonangioplastie bei Patienten mit AMI werden. We investigated 16 patients with ST segment elevation myocardial infarction who had an occluded coronary artery (TIMI 0) at initial angiogram. Instead of balloon angioplasty and stenting, patients were subjected to thrombectomy (Endicor X-sizer) and stenting. In 15/16 patients the occlusion could be crossed by the thrombectomy device resulting in TIMI flow 3 in all of them. Thereafter, stenting was performed. At final angiogram all 15 patients continued to show TIMI flow grade 3. Twelve-lead ECG was performed prior to and post-intervention. ST elevation was measured as the sum of eight leads for anterior infarction and of five leads for inferior infarction. In 13/15 patients, ECG analysis was possible (2 developed bundle branch block post-intervention). In all 13 patients, a >50% ST decrease of the initial amount of ST elevation was observed reaching a >70% reduction in 11 patients. Procedural complications were low (one coronary dissection after thrombectomy) and 30 days follow-up was uneventful. Thrombectomy using the Endicor X-Sizer device may become an attractive mechanical reperfusion strategy for patients with acute myocardial infarction.