Ulrike Krumsdorf

Percutaneous Left Atrial Appendage Transcatheter Occlusion to Prevent Stroke in High-Risk Patients With Atrial Fibrillation Early Clinical Experience

Background—Thromboembolism due to atrial fibrillation (AF) is a frequent cause of stroke. More than 90% of thrombi in AF form in the left atrial appendage (LAA). Obliteration of the appendage may prevent embolic complications. Methods and Results—We evaluated the feasibility and safety of implanting a novel device for percutaneous left atrial appendage transcatheter occlusion (PLAATO). LAA occlusion using the PLAATO system was attempted in 15 patients with chronic AF at high risk for stroke, who are poor candidates for long-term warfarin therapy. The implant consists of a self-expanding nitinol cage covered with a polymeric membrane (ePTFE). The LAA was successfully occluded in 15/15 patients (100%). Angiography and transesophageal echocardiography (TEE) during the procedure showed that the device was well-seated in all patients and that there was no evidence of perforation, device embolization, or interference with surrounding structures. In 1 patient, the first procedure was complicated by a hemopericardium, which occurred during LAA access. A second attempt 30 days later was successful with no untoward sequela. No other complications occurred. At 1-month follow-up, chest fluoroscopy and TEE revealed continued stable implant position with smooth atrial-facing surface and no evidence of thrombus. Conclusions—Thus, transcatheter closure of the LAA is feasible in humans. This novel implant technology may be appropriate for patients with AF who are not suitable candidates for anticoagulation therapy. Further trials are needed to show the long-term safety and its efficacy in reducing stroke.

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.

Cardiac perforation following transcatheter PFO closure.

From December 1998 to August 2001, transcatheter closure of patent foramen ovale (PFO) with an Amplatzer PFO occluder has been successfully performed in our center in 102 patients without severe complications. We are reporting the first known case of cardiac perforation by an Amplatzer PFO occluder. Cathet Cardiovasc Intervent 2003;58:111–113.

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.

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.

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.

Pathology, natural history and treatment of abdominal aortic aneurysms

SummaryWith increasing age of the population and improvement of diagnostic tools, the incidence of abdominal aortic aneurysms (AAA) has been rising steadily. Despite an improvement in operative and interventional treatment options, AAA is the cause of death in 1–3% of men over 65 years of age in industrial countries, mostly due to rupture [1]. Therefore, routine screening for AAA by ultrasonography has been postulated in the past: a 60 year old man with an abdominal aortic diameter of less than 3 cm has a life-time risk of developing AAA close to zero. However, routine screening has not been found to be cost effective. Despite of the results of two well-designed studies, the limits of AAA qualifying the patient for surgery or intervention in contrast to conservative treatment is still a matter of debate. The present review article summarizes the current knowledge of the pathology, incidence, risks, natural course as well as symptoms and current treatment strategies of AAA on the basis of the recent literature.

Does the STAF score help detect paroxysmal atrial fibrillation in acute stroke patients

Detecting paroxysmal atrial fibrillation (pAF) soon after acute cerebral ischaemia has a major impact on secondary stroke prevention. Recently, the STAF score, a composite of clinical and instrumental findings, was introduced to identify stroke patients at risk of pAF. We aimed to validate this score in an independent study population.

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 6300 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.

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

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.