Percutaneous implantation of the CoreValve self-expanding valve prosthesis in high-risk patients with aortic valve disease: the Siegburg first-in-man study.

BACKGROUND: The morbidity and mortality of surgical aortic valve replacement are increased in elderly patients with multiple high-risk comorbid conditions. Therefore, a prospective, single-center, nonrandomized study was performed in high-risk patients with aortic valve disease to evaluate the feasibility and safety of percutaneous implantation of a novel self-expanding aortic valve bioprosthesis (CoreValve). METHODS AND RESULTS: Symptomatic high-risk patients with an aortic valve area <1 cm2 were considered for enrollment. CoreValve implantation was performed under general anesthesia with extracorporeal support using the retrograde approach. Clinical follow-up and transthoracic echocardiography were performed after the procedure and at days 15 and 30 after device implantation to evaluate short-term patient and device outcomes. A total of 25 patients with symptomatic aortic valve stenosis (mean gradient before implantation, 44.2+/-10.8 mm Hg) and multiple comorbidities (median logistic EuroScore, 11.0%) were enrolled. Device success and procedural success were achieved in 22 (88%) and 21 (84%) patients, respectively. Successful device implantation resulted in a marked reduction in the aortic valve gradients (mean gradient after implantation, 12.4+/-3.0 mm Hg; P<0.0001). The mean aortic regurgitation grade was unchanged. Major in-hospital cardiovascular and cerebral events occurred in 8 patients (32%), including mortality in 5 patients (20%). Among 18 patients with device success surviving to discharge, no adverse events occurred within 30 days after leaving the hospital. CONCLUSIONS: Percutaneous implantation of the self-expanding CoreValve aortic valve prosthesis in high-risk patients with aortic stenosis with or without aortic regurgitation is feasible and, when successful, results in marked hemodynamic and clinical improvement.

Mechanisms of lumen narrowing of saphenous vein bypass grafts 12 months after implantation: an intravascular ultrasound study.

BACKGROUND: Previous long-term (>1 year) studies have suggested that saphenous vein bypass grafts (SVGs) undergo vascular remodeling similar to native coronary arteries. However, early morphologic stages of SVG remodeling have not been characterized in vivo. METHODS: Thirty SVGs were studied 12 months after implantation using an intravascular ultrasound automated pullback system. Intravascular ultrasound images were analyzed between 10 and 60 mm from the tip of the guide. Lumen area (LA), intima area (IA), and vessel area (VA, defined as the area within the outer border of a hypoechoic intimal layer) were computed at 3 cross sections: the minimum LA (MLA) site and the proximal and distal reference sites. Area changes (Delta) were calculated as the MLA site minus the average of the reference sites. RESULTS: In this cohort, 70% of the MLA sites had a smaller VA than the average references. On average, MLA sites had significantly smaller VA (9.7 +/- 2.9 vs 10.7 +/- 3.2 mm2, P < .01) and larger IA (2.5 +/- 2.1 vs 1.2 +/- 1.3 mm2, P < .01) than at the reference sites. The relative contribution of DeltaVA (-1.0 +/- 1.4 mm2) and DeltaIA (1.3 +/- 1.3 mm2) to lumen compromise (-2.3 +/- 1.4 mm2) were 43% and 57%, respectively. On the other hand, simple linear regression analysis revealed a significant positive correlation between DeltaIA and DeltaVA (y = -1.7 + 0.52x, r = 0.50, P < .01). CONCLUSIONS: Within the first year, the mechanism of lumen compromise in SVG is a combination of negative remodeling and intimal hyperplasia. Positive remodeling is seen in a minority of cases. However, the direction and extent of remodeling correlated with change in intimal thickness.

[Pulmonary thromboendarterectomy for chronic thromboembolic pulmonary hypertension]. / Chirurgie der chronischen pulmonalen Druckerhöhung. Indikationen und Ergebnisse der pulmonalen Thrombendarteriektomie.

Bilateral pulmonary thromboendarterectomy has been recognized as the first-choice therapeutic option for patients with chronic thromboembolic pulmonary hypertension. With careful patient selection, meticulous surgical technique and careful postoperative management the surgical procedure has proven potentially curative for these often severely incapacitated patients in whom prognosis is otherwise poor. By means of pulmonary angiography and multislice CT correct diagnosis is established and the crucial question of operability determined.In the presence of significant exertional dyspnea and/or elevation of pulmonary vascular resistance surgery is indicated when the thromboembolic obstructions are determined accessible to surgical removal. Suboptimal surgical results may be obtained in patients with solely peripheral location of lesions, i. e., beginning at the bronchopulmonary segmental arteries, and correct patient selection becomes crucial especially in advanced stages of disease of very high pulmonary vascular resistance and presence of right heart failure.The surgical techniques are standardized with use of median sternotomy with cardiopulmonary bypass, deep hypothermia and periods of circulatory arrest and consist of complete dissection of the intimal layer of the pulmonary branches containing the thromboembolic lesions as a true endarterectomy technique.The reported operative mortality for pulmonary thromboendarterectomy differs in the literature between 4.5% and 23.5% and probably reflects not only the various experiences with this patient group but most likely also the disparate policies in patient selection. The authors' experience comprises 250 surgically treated patients with an operative mortality of 14.4%. The immediate hemodynamic and functional improvement of patients following successful thromboendarterectomy is excellent with further improvement during the first year. Pulmonary hypertension recurs over time in a few patients because of embolism, thrombosis or progression of reactive vasculopathy. However, the functional improvement and decrease of right ventricular afterload are persistent in the vast majority.Given the poor results of lung transplantation, this is not an alternative, and patients with chronic thromboembolic pulmonary hypertension should undergo thromboendarterectomy, preferably in the most early stage of their disease.

Procedural and mid-term results in patients with aortic stenosis treated with implantation of 2 (in-series) CoreValve prostheses in 1 procedure.

OBJECTIVES: This study sought to assess post-procedural and mid-term outcome of patients, in which a second "in-series" CoreValve prosthesis (Medtronic, Minneapolis, Minnesota) was implanted during the same procedure. BACKGROUND: Because of the increasing number of patients implanted with CoreValves, the need for management of special complications has emerged. A misplaced prosthesis can be corrected by various maneuvers. An option is to pull the valve out of the aortic annulus into the ascending aorta or beyond and position a second one (in series). METHODS: Out of 277 patients who underwent CoreValve implantation with the 18-F device in our institution, we had to implant a second prosthesis (due to severe aortic regurgitation or dislocation of the first one) in 9 (3.2%). Immediate post-procedural as well as mid-term follow-up data (5 to 20 months, mean 10.6 +/- 6 months, total 95 patient-months) were collected for analysis. RESULTS: All implantations of the second device were successful, resulting in elimination of the gradient (mean gradient 43.1+/-4.0 mm Hg before to 7.0 +/- 1.1 mm Hg after implantation). There was no final aortic regurgitation grade >or=2+. The extra-anatomically placed first prosthesis (ascending aorta, n = 8; abdominal aorta, n = 1) did not cause any clinical sequelae or gradients. During mid-term follow-up, none of the 18 prostheses showed any sign of malfunction. Specifically, there were no signs of valve migration or of worsening paravalvular regurgitation. No case of valve thrombosis was documented. CONCLUSIONS: A second CoreValve can be safely and effectively implanted in an in-series manner, without periprocedural complications. No problems arose on mid-term follow-up, ranging up to 20 months.

Progress and current status of percutaneous aortic valve replacement: results of three device generations of the CoreValve Revalving system.

BACKGROUND: Percutaneous aortic valve replacement is a new emerging technology for interventional treatment of severe aortic valve stenosis in surgical high-risk patients. This study was intended to provide a summary of the development and current safety and efficacy status of the self-expanding CoreValve Revalving prosthesis. METHOD AND RESULTS: Between 2005 and 2008, we have enrolled 136 consecutive patients with percutaneous aortic valve replacement using the CoreValve prosthesis. In this prospective nonrandomized, single-center trial, we analyzed procedural outcome, complications and clinical status up to 1 year. First, second, and third generation of the CoreValve prosthesis were implanted in 10, 24, and 102 consecutive high-risk patients (logistic EuroScore: 23.1+/-15.0%) with severe symptomatic aortic valve stenosis. Mean transvalvular pressure gradient was 41.5+/-16.7 mm Hg. The procedural success rate increased from generation 1/2 to 3 from 70.0%/70.8% to 91.2% (P=0.003). The 30-day combined rate of death/stroke/myocardial infarction was 40.0%/20.8%/14.7% (P=0.11) for generation 1, 2, and 3, with no procedural death in generation 3. Pressure gradients improved significantly with a final mean gradient of 8.1+/-3.8 mm Hg. Overall functional status assessed by New York Heart Association class improved from 3.3+/-0.5 (pre) to 1.7+/-0.7 (post) (P<0.001) and remained stable in the follow-up. CONCLUSIONS: In experienced hands, percutaneous aortic valve replacement with the CoreValve system for selected patients with severe aortic valve stenosis has a high acute success rate associated with a low periprocedural mortality/stroke rate as well as remarkable clinical and hemodynamic improvements, which persist over time. Additional studies are now required to confirm these findings, particularly head-to-head comparisons with surgical valve replacement in different risk populations.

Percutaneous aortic valve replacement for severe aortic stenosis in high-risk patients using the second- and current third-generation self-expanding CoreValve prosthesis: device success and 30-day clinical outcome.

OBJECTIVES: We sought to determine both the procedural performance and safety of percutaneous implantation of the second (21-French [F])- and third (18-F)-generation CoreValve aortic valve prosthesis (CoreValve Inc., Irvine, California). BACKGROUND: Percutaneous aortic valve replacement represents an emerging alternative therapy for high-risk and inoperable patients with severe symptomatic aortic valve stenosis. METHODS: Patients with: 1) symptomatic, severe aortic valve stenosis (area <1 cm2); 2) age > or =80 years with a logistic EuroSCORE > or =20% (21-F group) or age > or =75 years with a logistic EuroSCORE > or =15% (18-F group); or 3) age > or =65 years plus additional prespecified risk factors were included. Introduction of the 18-F device enabled the transition from a multidisciplinary approach involving general anesthesia, surgical cut-down, and cardiopulmonary bypass to a truly percutaneous approach under local anesthesia without hemodynamic support. RESULTS: A total of 86 patients (21-F, n = 50; 18-F, n = 36) with a mean valve area of 0.66 +/- 0.19 cm2 (21-F) and 0.54 +/- 0.15 cm2 (18-F), a mean age of 81.3 +/- 5.2 years (21-F) and 83.4 +/- 6.7 years (18-F), and a mean logistic EuroSCORE of 23.4 +/- 13.5% (21-F) and 19.1 +/- 11.1% (18-F) were recruited. Acute device success was 88%. Successful device implantation resulted in a marked reduction of aortic transvalvular gradients (mean pre 43.7 mm Hg vs. post 9.0 mm Hg, p < 0.001) with aortic regurgitation grade remaining unchanged. Acute procedural success rate was 74% (21-F: 78%; 18-F: 69%). Procedural mortality was 6%. Overall 30-day mortality rate was 12%; the combined rate of death, stroke, and myocardial infarction was 22%. CONCLUSIONS: Treatment of severe aortic valve stenosis in high-risk patients with percutaneous implantation of the CoreValve prosthesis is feasible and associated with a lower mortality rate than predicted by risk algorithms.

First report on a human percutaneous transluminal implantation of a self-expanding valve prosthesis for interventional treatment of aortic valve stenosis.

BACKGROUND: Percutaneous aortic valve replacement is a new technology for the treatment of patients with significant aortic valve stenosis. We present the first report on a human implantation of a self-expanding aortic valve prosthesis, which is composed of three bovine pericardial leaflets inserted within a self-expanding nitinol stent. The 73-year-old woman presented with severe symptomatic aortic valve stenosis (mean transvalvular gradient of 45 mmHg; valve area of 0.7 cm2). Surgical valve replacement had been declined for the patient because of comorbidities, including previous bypass surgery. METHOD AND RESULTS: A retrograde approach via the common iliac artery was used for valve deployment. The contralateral femoral vessels were used for a temporary extracorporal circulation, unloading the left ventricle during the actual stent expansion. Clinical, hemodynamic, and echocardiographic outcomes were assessed serially during the procedure. Clinical and echocardiographic follow-up at day 1, 2, and 14 post procedure was performed to evaluate the short-term outcome. The prosthesis was successfully deployed within the native aortic valve, with accurate and stable positioning and with no impairment of the coronary artery or vein graft blood flow. 2D and doppler echo immediately after device deployment showed a significant reduction in transaortic mean pressure gradient (from 45 to 8 mmHg) without evidence of aortic or mitral valve insufficiency. The clinical status has then significantly improved. These results remained unchanged up to the day 14 follow-up. CONCLUSION: This case report demonstrates a successful percutaneous implantation of a self-expanding aortic valve prosthesis with remarkable functional and clinical improvements in the acute and short-term outcome.