Search

Aims: Our aim was to evaluate the long-term device performance and clinical outcomes of patients with symptomatic, severe aortic valve stenosis (AS) who underwent transcatheter aortic valve implantation (TAVI) with the CoreValve bioprosthesis., Methods and Results: The CoreValve CE Pivotal Study was a prospective, multicentre, single-arm TAVI trial using the CoreValve system. Valve performance, patient quality of life (QoL), New York Heart Association (NYHA) class, and mortality at four years were analysed in 126 patients (mean age 82.4 years, 42.9% male, mean logistic EuroSCORE 23.4%) with severe AS. Mean aortic valve gradient decreased from 46.9±16.1 mmHg at baseline to 9.8±4.1 mmHg at discharge and to 7.8±2.7 mmHg at four years. Mean effective orifice area increased from 0.7±0.2 cm2 to 1.8±0.4 cm2 after TAVI and was 1.6±0.5 cm2 at four years. There were no reports of structural valve deterioration or valve migration. There was sustained improvement in QoL and NYHA class in surviving patients. All-cause and cardiac survival was 45.3% and 62.6%, respectively, at four years., Conclusions: The CoreValve bioprosthesis demonstrates long-term durability, stable haemodynamic function, and no evidence of structural deterioration. Most surviving patients continued to have improved NYHA class and QoL at four years.

Aims: To analyse patient characteristics, decision-making processes, and outcomes of TAVI performed in hospitals with versus those without on-site cardiac surgery (CS)., Methods and Results: Current guidelines mandate transcatheter aortic valve implantation (TAVI) to be performed at hospitals with both cardiology and on-site CS departments. Some hospitals in Germany perform TAVI without CS departments in-house. We analysed the data of 1,432 patients enrolled in the German TAVI registry at 27 hospitals between January 2009 and June 2010. Nineteen of these had on-site CS (group 1), while eight centres performed TAVI with no CS department at their institution (group 2). Patients in group 2 (n=178, 12% of the overall study population) were older than in group 1 (mean age 82.6±6.3 years vs. 81.6±6.2 years) with similar logistic EuroSCORE (average: 21%). Patients in group 2 were haemodynamically more stable (higher blood pressures, better ejection fraction, less low-flow or low-gradient aortic stenosis, and less urgent procedures). Procedure times and use of contrast were higher in group 2. The procedural success rate was higher in group 1 (98% vs. 95%). Post-procedural complications were similar in the two groups with 30-day mortality of 6.2% in group 2 compared with 8.3% in group 1 patients., Conclusions: Only 12% of patients enrolled in the German TAVI registry underwent TAVI at hospitals without an on-site CS department. Overall patient characteristics appeared to be similar, although patients in non-CS centres appeared to be haemodynamically more stable and more often had a history of previous heart surgery. Despite longer procedures, complication rates were similar. These preliminary data in a modest number of patients suggest the feasibility of performing TAVI in appropriately selected patients at hospitals without CS but this requires confirmation in future studies involving a large number of patients.

Aims: We present our first clinical experience to substitute ethanol with special designed microspheres in a TASH procedure (transcatheter ablation of septal hypertrophy). TASH is a standard approach for the treatment of patients with hypertrophic obstructive cardiomyopathy, severely symptomatic despite maximal medical therapy. However, the injection of alcohol remains a source of some possible complications., Methods and Results: We substituted alcohol with special designed microspheres. A highly symptomatic HOCM patient underwent a procedure of percutaneous ablation of his hypertrophied septum with the use of Embozene microspheres. The procedure was successful, as the gradient was reduced from 70 before the procedure to 10 mmHg afterwards., Conclusions: TASH by means of microspheres embolisation instead of alcohol was a safe and successful in the short-term procedure.

Aims: The optimal clinical protocol to detect fractures of transcatheter aortic valves is unknown. To the best of our knowledge, there are no published reports describing stent or frame fractures following transcatheter aortic valve implantation. The purpose of this study is two-fold: (1) to determine the optimal fluoroscopic protocol to identify potential fractures of the Medtronic CoreValve frame; and (2) to implement this protocol in the analysis of the fluoroscopic films of patients implanted with the CoreValve device with 1-year minimum follow-up., Methods and Results: Considering the resolution of fluoroscopy (approximately 0.2 mm), we used a 0.2 mm diamond-cutter to create a single fracture in a single strut of two CoreValve frames. An intact CoreValve prosthesis was used as control. These prostheses were subsequently implanted in post-mortem heart specimens. A protocol involving still frames and rotational (left-right and cranial-caudal) fluoroscopic imaging was then applied to the heart specimens. The experimentally induced fractures were detectable on the rotational cine runs (left-right and cranial-caudal); in some of the fixed acquisition sequences, however, the fractures were undetectable. The fluoroscopic protocol was retrospectively applied to the films of 58 patients who underwent implantation with the CoreValve System between October 2005 and August 2008 and had at least 1-year follow-up. The mean and median follow-up times were 22 months and 24 months, respectively (range 12 to 36 months). Rotational cine films (only left-right lateral) were available in 39 patients (60%). No frame fractures of the CoreValve frame were identified., Conclusions: Rotational cine runs in the left-right and cranial-caudal directions should be mandatory in the clinical assessment of the structural integrity of the CoreValve frame. No frame fractures were identified in 58 patients implanted with the Medtronic CoreValve device with 2-year mean follow-up.

Aims: To describe the procedural performance and 30-day outcomes following implantation using the 18 Fr CoreValve Revalving System (CRS) as part of the multicentre, expanded evaluation registry, 1-year after obtaining CE mark approval., Methods and Results: Patients with symptomatic severe aortic stenosis and logistic Euroscore > or =15%, or age > or =75 years, or age > or =65 years associated with pre-defined risk factors, and for whom a physician proctor and a clinical specialist were in attendance during the implantation and who collected the clinical data, were included. From April 2007, to April 2008, 646 patients with a mean age of 81 +/- 6.6 years, mean aortic valve area 0.6 +/- 0.2 cm2, and logistic EuroSCORE of 23.1 +/- 13.8% were recruited. After valve implantation, the mean transaortic valve gradient decreased from 49.4 +/- 13.9 to 3 +/- 2 mmHg. All patients had paravalvular aortic regurgitation < or = grade 2. The rate of procedural success was 97%. The procedural mortality rate was 1.5%. At 30 days, the all-cause mortality rate (i.e, including procedural) was 8% and the combined rate of death, stroke and myocardial infarction was 9.3%., Conclusions: The results of this study demonstrate the high rate of procedural success and a low 30-day mortality in a large cohort of high-risk patients undergoing transcatheter aortic valve implantation (TAVI) with the CRS.

Aims: The Custom NX 36 Drug Eluting Stent (DES) System is designed to treat coronary lesions via in situ stent length customisation. The stent evaluated in this study consists of nine interdigitated stent segments, each 4 mm in length, coated with a biodegradable formulation of Biolimus A9 and Poly-Lactic-Acid, a biodegradable drug carrier, and loaded into a unique sheath protected, integrated balloon delivery system., Methods and Results: The objective of this non-randomised prospective multicentre CUSTOM I Trial was to demonstrate the safety of in situ stent length customisation in 30 consecutive patients. Angiographic (QCA) and intravascular ultrasound (IVUS) follow-up was performed at two cohort time intervals: four (n=10) or eight (n=20) months. Mean lesion length and reference vessel diameters were 17.7 +/- 9.6 mm and 2.6 +/- 0.3 mm, respectively. Procedural success was 93%. There were three MACEs in the study population from enrollment through to twenty-four month follow-up. The in-hospital MACE rate was 2/30, with non-Q-wave myocardial infarctions events in two patients who recovered without further sequelae. At five months, one patient who had crossed over initially to PTCA required CABG surgery. Results from QCA and IVUS assessments at four and eight months showed no binary restenosis, mean in-stent late luminal loss of 0.25 +/- 0.23 mm and 0.26 +/- 0.23 mm., Conclusions: This first evaluation of the new customisable Biolimus A9-eluting Custom NX stent suggests safety and efficacy through twenty-four month follow-up. Further evaluations are warranted to confirm the overall favourable outcomes.

Aim: To study the feasibility, safety and efficacy of the Recover(R) LP 2.5 assist device in patients scheduled for high risk off-pump coronary bypass surgery, percutaneous coronary intervention or patients in cardiogenic shock., Methods and Results: 40 patients presenting with cardiogenic shock (n=13) or scheduled for a high risk revascularisation (n=27) were included.36 were selected for safety and feasibility analysis. In 3 patients the pump could not be placed in an adequate position. 5 patients had access related complications. In 9 patients free Hb rose above 80 mg/dl. 3 malfunctions and early device-removal occurred. After device modifications these problems did not recur. CO in the shock group increased significantly: 4.4 l/min+/-1.9 to 4.8 l/min+/-1.2 (p=0.0178).The left ventricular filling pressures decreased in both groups (22 mmHg+/-7.5 to 16 mmHg+/-6 in the shock group, [p=0.0008] and over 6 hours from 14.3 mmHg+/-5.8 to 10 mmHg+/-2.9 in the high-risk revascularisation group,[p=0.0327])., Conclusions: The Recover(R) LP 2.5 micro axial pump allows, via percutaneous approach, partial unloading of the left ventricle. The technique is, after design modifications, feasible and safe and results in haemodynamic improvement.