Efficacy of different devices for transcatheter closure of patent foramen ovale assessed by serial transoesophageal echocardiography and rates of recurrent cerebrovascular events in a long-term follow-up.

AIMS: Closure of patent foramen ovale (PFO) is non-inferior to medical treatment for patients with cryptogenic stroke. Results in randomised trials might be based on the different types of used occluders. We determined residual shunting with serial contrast transoesophageal echocardiography (cTEE) and evaluated rates of recurrent cerebrovascular events in a long-term follow-up. METHODS AND RESULTS: cTEE was repeated three and 12 months after PFO closure using AMPLATZER (n=109), BioSTAR (n=68), Cardia (n=104) or Premere (n=54) occluders. Closure was demonstrated in 91.6% and 95.9% of patients after three and 12 months. Closure rates were not different among groups (p=0.58; p=0.94). The PFO diameter was a risk factor for residual shunting (p=0.02), but not the prevalence of an atrial septal aneurysm (ASA). During follow-up, including 1,815 patient-years (PY), eight patients suffered a stroke (0.44/100 PY) and seven patients a transient ischaemic attack (0.39/100 PY). Rates of recurrent cerebrovascular events were similar among the four groups. CONCLUSIONS: Closure at three or 12 months (as measured by cTEE) and rates of recurrent cerebrovascular events were similar among occluder groups. PFO diameter was a risk factor for residual shunting, but not the presence of ASA. The rate of recurrent cerebral ischaemic events was low.

Preserved prognostic value of preinterventional troponin T levels despite successful TAVI in patients with severe aortic stenosis.

BACKGROUND: Elevated concentrations of troponin T have prognostic impact in patients with various cardiovascular diseases including those with severe aortic stenosis. Transcatheter aortic valve implantation (TAVI) has improved prognosis for patients without a surgical option. Whether this affects the prognostic value of preinterventional troponin T remains unclear. METHODS: We therefore conducted a prospective study in 198 consecutive patients with subsequent, successful transfemoral TAVI and analyzed cardiac troponin T (cTnT) levels with a new generation, high-sensitive troponin T assay before and after TAVI, as well as their prognostic value after 12 months. RESULTS: Patients with severe aortic stenosis (AS) showed significant elevation of preinterventional cTnT levels. Postinterventional cTnT levels significantly rose further about sevenfold after transfemoral TAVI and peaked at day three until they steadily declined thereafter. Baseline renal function (P = 0.011), the duration of intraprocedural rapid pacing (P = 0.0012), and baseline cTnT (P = 0.0001) values predicted the magnitude of postinterventional cTnT elevations. Interestingly, Kaplan-Meier curve analysis revealed, that although cTnT levels were not predictive for short-term mortality, preinterventional as well as postinterventional peak cTnT showed prognostic value for 1-year mortality, regardless of successful TAVI. CONCLUSIONS: Pre- and postinterventional hscTnT levels signal adverse 1-year mortality in patients with severe AS independent of successful aortic valve replacement.

Left atrial appendage occlusion in atrial fibrillation after intracranial hemorrhage.

OBJECTIVE: To evaluate the safety and feasibility of percutaneous left atrial appendage occlusion (LAAO) in patients with atrial fibrillation (AF) and previous intracranial hemorrhage (ICH). METHODS: In an explorative, prospective, single-center, observational study, LAAO was performed in patients with previous ICH and AF using the Amplatzer Cardiac Plug device. Risks of ischemic strokes and hemorrhagic complications were estimated using the CHA2DS2Vasc score and the HAS-BLED score. Before and 1, 6, 12, and 24 months after the procedure, clinical status and complications were recorded. Major complications were predefined as periprocedural stroke, death, pericardial effusion, and device embolism. RESULTS: LAAO was performed in 20 patients. Based on CHA2DS2Vasc score (mean 4.5 ± 1.4) and HAS-BLED score (mean 4.7 ± 1.0), annual risks of stroke and hemorrhagic complications were 4.0%-6.7% and 8.7%-12.5%, respectively. No patient had a procedure-related complication. Minor postprocedural complications were observed in 4/20 patients (2 inguinal hematoma, 1 self-limiting asystole, and 1 thrombus formation on device). No ischemic or hemorrhagic stroke occurred during a mean follow-up of 13.6 ± 8.2 months. CONCLUSIONS: In this first study of LAAO in patients with previous ICH, LAAO appears feasible and safe. A larger, controlled trial is needed to assess the efficacy and safety of the procedure compared to other preventive measures. CLASSIFICATION OF EVIDENCE: This study provides Class III evidence that in patients with a history of previous ICH and AF, percutaneous LAAO is safe and feasible.

Percutaneous edge-to-edge repair of mitral regurgitation as a bail-out strategy in critically ill patients.

Percutaneous edge-to-edge mitral valve repair using the MitraClip device has evolved as a new tool for the treatment of severe mitral valve regurgitation. This technique has been evaluated in both surgical low- and high-risk patients. The aim of this study was to assess the feasibility and efficacy of MitraClip implantation in critically ill, unstable patients with severe mitral regurgitation who would persistently need inotropes or who could not be weaned from a ventilator. Six patients with the above-mentioned criteria were identified among the 87 patients that were treated with MitraClip implantation between October 2009 and January 2012 at our institution. All patients were considered as surgical high-risk patients with a Society of Thoracic Surgeons (STS) score between 8.0% and 56.9%. In all patients, MitraClip implantation was successfully achieved without relevant complications. More importantly, all patients showed rapid clinical improvement within a few days, allowing discontinuation of inotropes and/or weaning from a respirator and finally a transfer to a regular ward or discharge home. These data emphasize the safety profile of the MitraClip system in multimorbid, high-risk patients. In addition, it demonstrates the applicability of this treatment in unstable and critically ill conditions as a tool for acute stabilization.

Objective quantification of aortic valvular structures by cardiac computed tomography angiography in patients considered for transcatheter aortic valve implantation.

PURPOSE: To test the ability of a model-based segmentation of the aortic root for consistent assessment of aortic valve structures in patients considered for transcatheter aortic valve implantation (TAVI) who underwent 256-slice cardiac computed tomography (CT). METHODS: Consecutive patients (n = 49) with symptomatic severe aortic stenosis considered for TAVI and patients without aortic stenosis (n = 17) underwent cardiac CT. Images were evaluated by two independent observers who measured the diameter of the aortic annulus and its distance to both coronary ostia (1) manually and (2) software-assisted. All acquired measures were compared with each other and to (3) fully automatic quantification. RESULTS: High correlations were observed for 3D measures of the aortic annulus conducted on multiple oblique planes (r = 0.87 and 0.84 between observers and model-based measures, and r = 0.81 between observers). Reproducibility was further improved by software-assisted versus manual assessment for all the acquired variables (r = 0.98 versus 0.81 for annulus diameter, r = 0.94 versus 0.85 for distance to the left coronary ostium, P < 0.01 for both). Thus, using software-assisted measurements very low limits of agreement were observed for the annulus diameter (95%CI of -1.2 to 0.6 mm) and within very low time-spent (0.6 ± 0.1 min for software-assisted versus 1.6 ± 0.3 min per patient for manual assessment, P < 0.001). Assessment of the aortic annulus using the 3D model-based instead of manual 2D-coronal measurements would have modified the implantation strategy in 12 of 49 patients (25%) with aortic stenosis. Four of 12 patients with potentially modified implantation strategy yielded postprocedural moderate paravalvular regurgitation, which may have been avoided by implantation of a larger prosthesis, as suggested by automatic 3D measures. CONCLUSION: Our study highlights the usefulness of software-assisted preprocedural assessment of the aortic annulus in patients considered for TAVI.

The groin first approach for transcatheter aortic valve implantation: are we pushing the limits for transapical implantation?

OBJECTIVE: Transcatheter aortic valve implantation (TAVI) is a therapeutic option for old and multimorbid patients with severe aortic stenosis. When applying the groin first approach by transfemoral implantation, patients in the transapical group are highly selected with even higher morbidity. We report outcome of the transapical group. METHODS: Between April 2008 and May 2011, 267 patients underwent TAVI through either a transfemoral (n = 201 CoreValve, n = 33 Edwards Sapien prostheses; mean age 81 ± 6 years, logistic EuroSCORE 19.5 ± 12.6 %; 4-76, STS score 7.2 ± 4 %; 1.5-28.9) or transapical approach (n = 33 Edwards Sapien prostheses; mean age 80 ± 1 years, logistic EuroSCORE 31.6 ± 17.1 %; 9.4-69.1, STS score 12.8 ± 7.1 %; 2.5-28.8). The transapical access was chosen only when transfemoral implantation was not possible. RESULTS: EuroSCORE and STS score were significantly higher in the transapical group (p = 0.001, respectively). A 30-day survival was comparable with 87.9 % in the transapical versus 92 % in the transfemoral group (p = 0.52). In the transapical group, female gender was predominant (n = 23; 70 %). Eight patients underwent previous cardiac surgery. All transapical implantations were successful. No bleeding or neurological complications occurred. Six patients required postoperative pacemaker implantation. Cardiac decompensation with concomitant pneumonia was the underlying cause for early mortality, except for one patient with abdominal malperfusion. Follow-up (0-37 months) was complete in 100 %, nine patients died after 30 days postoperatively (6 cardiac and 3 non-cardiac related). Echocardiography revealed good valve function with not more than mild paravalvular incompetence. CONCLUSIONS: Groin first approach is reasonable due to less invasive implantation technique. However, despite even higher predicted mortality, transapical aortic valve implantation is non-inferior to transfemoral approach.

C-reactive protein kinetics and its prognostic value after transfemoral aortic valve implantation.

Transcatheter aortic valve implantation (TAVI) has become an established therapeutic option in high-risk patients with severe aortic valve stenosis. The potential threat of a postinterventional infection is one of several life-threatening complications. We have analyzed C-reactive protein levels in all patients who underwent successful transfemoral aortic valve implantation between July 2009 and January 2011. CRP and leukocyte counts were measured within 24 hours prior to implantation and daily up to 14 days after implantation. Patients with CRP levels above 109 mg/L (75th percentile; normal range <5 mg/L) were additionally analyzed. We performed 215 transfemoral aortic valve implantations (Edwards and CoreValve). The mean CRP increased after TAVI with a 7.5-fold peak on day 3, and was nearly normalized on day 14. Interestingly, mean leukocyte count remained within the normal range. To identify further independent predictors for post-TAVI elevation of CRP above the 75th percentile, multivariate logistic regression analysis was performed. This showed a significant relationship for patients with elevated baseline CRP values above 11.9 mg/L, for a body mass index above 25 kg/m², for a logistic EuroSCORE ≥22% and for signs of postinterventional infection. Elevated baseline (>6.4 mg/L) and elevated peak (>102 mg/L) CRP values were associated with higher 30-day mortality. In conclusion, CRP elevation after TAVI should be expected to peak on day 3. An infection should be taken into account if CRP increases above 110 mg/L and if patients show other signs of infection. Elevated CRP at baseline and at day 3 is associated with higher 30-day mortality.

Improved procedural results after CoreValve implantation with the new AccuTrak delivery system.

AIMS OF THE STUDY: Transcatheter aortic valve implantation (TAVI) has become an established treatment for severe aortic stenosis in patients with unacceptable high-surgical risk. Recently, the new AccuTrak delivery system for improved deliverability of the CoreValve aortic bioprosthesis was launched. It has not yet been shown if the new delivery catheter leads to optimized positioning and improved procedural outcomes. METHODS AND RESULTS: We conducted a retrospective single-center analysis and evaluated 70 consecutive patients (35 with the original delivery catheter and 35 with the new AccuTrak catheter) for anatomic positioning and related outcome parameters like postinterventional aortic regurgitation (AR) and the need for permanent pacemaker insertion, after CoreValve implantation. The use of the AccuTrak delivery catheter resulted in significantly higher positioning of the CoreValve prosthesis in the left ventricular outflow tract (distance from annulus to lower edge of prosthesis 7.0 mm [5.5 to 9.4 mm] for the AccuTrak group vs. 8.8 mm [7.1 to 11.2 mm] for the original system; median [interquartile range]; P = 0.0068). Moreover, the optimized positioning resulted in reduced rates of significant (≥grade 2) AR assessed by postinterventional aortography and echocardiography (P = 0.044 and P = 0.0275, respectively). Despite improved positioning, no differences in the need for permanent pacemaker implantation were observed. CONCLUSIONS: Our retrospective analysis indicates improved positioning with reduced postinterventional AR with the new CoreValve AccuTrak delivery system. Whether this may also affect the need for permanent pacemaker insertion or long-term outcome after TAVI needs to be evaluated in larger studies.

Incidence of late occurring bradyarrhythmias after TAVI with the self-expanding CoreValve(®) aortic bioprosthesis.

OBJECTIVES: Analysis of timing, type, electrocardiographic and patient characteristics of postinterventional bradyarrhythmias after CoreValve implantation. BACKGROUND: Transcatheter aortic valve implantation (TAVI) has become an accepted alternative to surgical therapy in patients with high risk. Among the major drawbacks of this procedure is the need for postprocedural permanent pacemaker implantation (PPM). Although predictors for the postinterventional need for PPM are increasingly recognized, thresholds and rates may vary between centers. METHODS: We conducted a retrospective single-center analysis in 130 consecutive patients with successful transfemoral CoreValve implantation without preexisting pacemaker implants. RESULTS: Postprocedural bradyarrhythmias occurred in 36.2% post-TAVI. Compared to those without postinterventional bradyarrhythmias, these patients had longer preprocedural PR intervals (P = 0.012), broader QRS-complexes (P = 0.001) and prolonged QTc intervals (P = 0.001). Patients with postinterventional bradyarrhythmias had significantly more often preprocedural RBBB (35.2 vs. 14.1%; P = 0.0059). In contrast, no difference was observed with respect to annulus/prosthesis ratio or the use of the large 29-mm prosthesis. The vast majority of patients developed bradyarrhythmias directly after CoreValve implantation or within the first 48 h thereafter. However, 7.6% developed significant bradyarrhythmia more than 48 h after TAVI, and 3.8% of the whole cohort developed significant bradyarrhythmias even >96 h after TAVI. One patient died at day 5 post-TAVI due to asystole. CONCLUSIONS: Late occurrence of bradyarrhythmias should be recognized as a significant contributor to postprocedural outcome after TAVI. Although this is a well known phenomenon after surgical valve replacement, it is less recognized after TAVI.

Acute safety and 30-day outcome after percutaneous edge-to-edge repair of mitral regurgitation in very high-risk patients.

Percutaneous edge-to-edge mitral valve repair using the MitraClip device has evolved as a new tool for the treatment of severe mitral valve regurgitation. This technique has been evaluated in surgical low- and high-risk patients. Patients with advanced age, multiple morbidities, and heart failure will be the first to be considered for a nonsurgical approach. Thus safety and feasibility data in very high-risk patients are crucial for clinical decision making. The aim of this study was to assess short-term safety and clinical efficacy in high-risk patients with a Society of Thoracic Surgeons (STS) score >15% after MitraClip implantation (mean STS score 24 ± 4%). All relevant complications, mortality, echocardiographic improvement, and changes in brain natriuretic peptide, high-sensitive troponin T, 6-minute walk distance test, and New York Heart Association functional class were collected in patients within 30 days after MitraClip implantation. Mitral regurgitation had significantly decreased after 30 days from grade 2.9 ± 0.2 to 1.7 ± 0.7 (p < 0.0001). Accordingly, New York Heart Association functional class had significantly improved from 3.38 ± 0.59 to 2.2 ± 0.4 (p <0.001). Objective parameters of clinical improvement showed a significant increase in 6-minute walk distance test (from 194 ± 44 to 300 ± 70 m, p <0.01) and insignificant trends in brain natriuretic peptide (10,376 ± 1,996 vs 4,385 ± 1,266 ng/L, p = 0.06) and high-sensitive troponin T (43 ± 8.9 vs 36 ± 7.7 pg/L, p = 0.27) improvement. Thirty-day mortality was 0. Two patients developed a left atrial thrombus, 1 patient was on a ventilator for >12 hours, and 1 patient had significant access site bleeding. In conclusion, this study shows that percutaneous edge-to-edge mitral valve repair can be safely performed even in surgical high-risk patients with an STS score >15. At 1-month follow-up most patients showed persistent improvement in mitral regurgitation and a clinical benefit.

Transcatheter aortic valve implantation after previous mechanical mitral valve replacement: expanding indications?

BACKGROUND: Cardiac operation for severe aortic stenosis after previous mitral valve replacement is a surgical challenge in older patients with multiple morbidities. Transcatheter aortic valve implantation (TAVI) after previous mechanical mitral valve replacement has been considered a high-risk procedure, owing to possible interference with the mitral valve prosthesis. METHODS: Since August 2008, 5 female high-risk patients with severe aortic stenosis and previous mitral valve replacement (mean ± SD age, 80 ± 5.1 years; logistic EuroSCORE, 39.3% ± 20.5%) underwent TAVI with a pericardial xenograft valve that was fixed with a stainless steel, balloon-expandable stent (Edwards Lifesciences SAPIEN). We used a transapical approach in 4 patients and a transfemoral approach in 1 patient. Transesophageal echocardiography and multidetector computed tomography were used for preoperative planning and assessment of operation feasibility. The mean distance between the aortic annulus and the mitral valve prosthesis was 10 ± 1 mm (range, 9-11 mm). RESULTS: TAVI was performed successfully in all 5 patients. There was no direct or functional interference with the mechanical mitral valve prostheses. Echocardiography revealed good valve function with no more than mild paravalvular incompetence early in the postoperative period and during routine follow-up. There were no neurologic events. After an initially uneventful course with good aortic valve function at the most recent echocardiography evaluation, however, 2 of the patients died from fulminant pneumonia on postoperative days 4 and 48. CONCLUSION: TAVI is technically feasible in high-risk patients after previous mechanical mitral valve replacement; however, careful patient selection is mandatory with respect to preoperative clinical status and anatomic dimensions regarding the distance between aortic annulus and mitral valve prosthesis.

Large atrial thrombus formation after MitraClip implantation: is anticoagulation mandatory?

Percutaneous mitral valve repair with the MitraClip system has evolved as a promising new technique for the non-surgical treatment of mitral regurgitation (MR). To date, few major adverse events have been reported in initial studies with this technique. The case is reported of a 70-year-old patient who underwent successful MitraClip implantation. Routine pre-discharge transesophageal echocardiography on day 5 after implantation showed large thrombus formation in the left atrium (posterolateral wall) and on the right atrial side of the septum. The patient had not received any anticoagulation after clip implantation, and did not have any monitored episodes of atrial fibrillation prior to the scheduled discharge day. It is concluded that mandatory anticoagulation for at least one month should be considered in patients undergoing MitraClip implantation.

Percutaneous and surgical treatment of mitral valve regurgitation.

BACKGROUND: Mitral valve regurgitation is the second most common clinically relevant valvular heart disease in adults, with an incidence of about 2% to 3% per year. Surgical mitral valve repair is the treatment of choice. Recent years have seen major advances in minimally invasive mitral valve surgery. Several new catheter-based techniques are now being clinically evaluated, including percutaneous endovascular mitral valve repair with a mitral clip. METHOD: This review is based on a selective review of the literature and on the authors' clinical experience. RESULTS: Minimally invasive and reconstructive techniques for mitral valve surgery have come into more common use in recent years. In Germany, more than 50% of all mitral valve defects are now treated with a valve-preserving repair procedure. At the same time, percutaneous techniques have been developed that enable reduction of mitral regurgitation in the cardiac catheterization laboratory, without surgery. The implantation of a mitral clip is the sole currently approved technique of this type. In a recently published, randomized comparative clinical trial (EVEREST II), it was found to be safer, but less effective, than surgery. CONCLUSION: Mitral valve surgery remains the treatment of choice for severe mitral regurgitation. For patients at high risk from surgery, and particularly those with severe heart failure, the implantation of a mitral clip is a safe and feasible treatment option.

Usefulness of percutaneous aortic valve implantation to improve quality of life in patients >80 years of age.

Older patients with aortic stenosis cannot always be offered conventional surgical aortic valve replacement at an acceptable risk. Transcatheter aortic valve implantation (TAVI) is currently considered an alternative treatment option with lower periprocedural risks. However, its effect on post-TAVI quality of life and clinical improvement has not been systematically and prospectively evaluated in those of advanced age. Thus, the aim of the present study was to assess the clinical improvement in geriatric patients after TAVI, with a special emphasis on quality of life. In the present study, we assessed the quality of life and brain natriuretic peptide in patients aged >80 years, before and 6 months after transfemoral CoreValve implantation. Of 87 prospectively studied patients with severe, symptomatic aortic stenosis at an age of ≥81 years, 80 survived for 6 months and were able to attend the follow-up visit with a quality of life assessment, using the Medical Outcomes Trust Short Form 36-Item Health Survey (average age 86 ± 2.9 years). The average scores of all 8 health components had improved significantly after TAVI. The greatest gain was seen in physical functioning (improvement from 23.4 ± 6.0 to 67.8 ± 13.7; p <0.001). The lowest gain was seen in bodily pain (improved from 37.5 ± 9.4 to 51.3 ± 11.5; p <0.05). Similarly, both the physical and the mental component summary scores improved significantly. This was consistent with significant improvement in brain natriuretic peptide levels (5,770 ± 8,016 to 1,641 ± 3,650 ng/L; p <0.0001). In conclusion, the results of the present study have shown a significant clinical benefit from TAVI in a patient population aged ≥81 years.

Transcatheter closure of patent foramen ovale with radiofrequency: acute and intermediate term results in 144 patients.

AIMS: Currently available devices for transcatheter closure of patent foramen ovale (PFO) which rely on a permanent implant have limitations, including late complications. The study objective was to evaluate the safety, feasibility, and effectiveness of the PFx Closure System, the first transcatheter technique for PFO closure without an implantable device. METHODS AND RESULTS: A prospective study of 144 patients was conducted at nine clinical sites from October 2005 through August 2007. All patients had a history of cryptogenic stroke, transient ischemic attack, migraines, or decompression illness. The mean balloon stretched diameter of the PFO was 7.9 +/- 2.5 mm. Technical success (successful application of radiofrequency energy) was achieved in 130 patients. One patient required a transfusion as a result of blood loss during the procedure. There were no other major procedural complications. There were no recurrent strokes, deaths, conduction abnormalities, or perforations following the procedure. At a mean follow-up of 6 months, successful closure was achieved in 79 patients (55%). In PFOs with balloon sized or stretched diameters less than 8 mm, the closure rate was 72% (53/74). CONCLUSION: This study demonstrates that transcatheter closure of a PFO without a permanent implant is technically feasible and safe. Further technique and device modifications are required to achieve higher closure rates.

Significance of close surveillance of patients with peripheral arterial disease.

BACKGROUND: Peripheral arterial disease (PAD) indicates generalized atherosclerosis but is still underdiagnosed and undertreated. METHODS: Data were collected from patients with PAD from the Department of Cardiology and Angiology, University of Heidelberg, Germany. The prevalence of cardiovascular risk factors and medication were documented. RESULTS: Atherogenic risk factors, cardiovascular disease, and cerebrovascular disease were highly prevalent. By continuous care at the university clinic, in addition to family medicine treatment, the use of platelet inhibitors, antihypertensives, and lipid-lowering therapy was increased. Ankle-brachial index and walking distance improved. CONCLUSION: Long-term treatment at the university clinic had positive effects on atherogenic risk factors. The regular use of secondary preventive medication was improved. Still, this patient population remained undertreated and showed a high incidence of vascular event rates and a need for vascular interventions. This study implies the importance of both specialists and general practitioners in the care of these individuals.

Nitinol stent implantation in TASC A and B superficial femoral artery lesions: the Femoral Artery Conformexx Trial (FACT).

PURPOSE: To investigate the impact of nitinol stenting of superficial femoral artery (SFA) lesions with a maximum length of 10 cm (TASC-II A or B) on 1-year outcomes compared to a historical study cohort from the Femoral Artery Stent Trial (FAST). METHODS: Between January 2004 and August 2005, 6 study sites enrolled 110 symptomatic patients (75 men; mean age 68+/-9 years) with a single de novo >70% SFA lesion <10 cm long treated with the self-expanding nitinol Conformexx stent. The primary study endpoint was binary restenosis determined by duplex ultrasound at 12 months. Secondary 12-month endpoints were target lesion revascularization (TLR), ankle-brachial index (ABI), mean Rutherford category, >1-class change in Rutherford category, and major adverse events. Data were analyzed according to the intention-to-treat principle and according to the actual treatment received ("on treatment" analysis). Outcomes were compared to the historical balloon angioplasty (BA) arm and the Luminexx 3 stent arm of the randomized FAST study. RESULTS: Technical success was achieved in 106 (96%) patients; at 1 year, the primary endpoint of ultrasound-assessed binary restenosis was reached in 14 (23.3%) of 60 patients (95% CI 13.4% to 36%). This restenosis rate was lower versus the historical BA (38.6%, p=0.057) or Luminexx 3 stent controls (31.7%, p=0.284) from FAST. The clinically driven TLR was 7.4% (7 of 94 clinically controlled patients), which was also lower compared to 18.3% (p=0.098) and 14.9% (p=0.267) for the historical BA and Luminexx 3 stent groups, respectively. The mean Rutherford category was reduced from 2.75+/-0.79 to 0.94+/-1.38 (p<0.0001); 85.1% were improved by at least 1 Rutherford category. The ABI increased from 0.62+/-0.15 to 0.85+/-0.20 (p<0.0001). CONCLUSION: This study of patients with SFA lesions documented favorable outcomes using nitinol stents in TASC-II A or B lesions after 1 year. The study was underpowered to prove superiority of the Conformexx nitinol stent design compared to historical balloon only or Luminexx 3 stent groups.

Treatment of iatrogenic femoral pseudoaneurysm by ultrasound-guided compression therapy and thrombin injection.

Development of an arterial pseudoaneurysm is a common complication following cardiac catheterization. We analyzed data from 6,300 patients who received left heart catheterization at our institution. One day after the procedure, approximately 10% of the patients were examined with duplex sonography. In 204 patients (3.0%), a pseudoaneurysm of the femoral artery was diagnosed. All patients underwent compression therapy. Thereby, 159 of the pseudoaneurysms could be treated successfully. The remaining 45 pseudoaneurysms had a maximal diameter of more than 1.5 cm. Forty-two patients underwent ultrasound and biopsy-line-guided thrombin injection without complications. This strategy resulted in a successful occlusion in 41 cases. Pseudoaneurysms smaller than 2 cm can be treated with compression therapy. Larger pseudoaneurysms can be occluded by thrombin injection using ultrasound guidance. Patients with a pseudoaneurysm with a wide "neck" should be treated surgically, because the risk of an arterial occlusion following thrombin injection cannot be excluded.