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OBJECTIVES The aim of this study was to evaluate the initial and short-term results of a new apical access and closure device to facilitate and standardize the transapical (TA) approach to transcatheter aortic valve implantation (TAVI). METHODS The apical access, stabilization and closure (ASC™) device consists of three components: an introducer system, a left ventricular low-profile titanium coil and a closure cap. The ASC™ introducer system is anchored and rotated into the myocardium almost like a corkscrew, using the titanium coil. Following the TA-AVI procedure, the closure cap is introduced and delivered through the system into the titanium coil for final sealing. RESULTS A total of 11 high-risk elderly patients (EuroSCORE I: 27.8 ± 16.7; EuroSCORE II: 6.6 ± 5.0 and The Society of Thoracic Surgeons (STS) score: 5.9 ± 2.7%) were evaluated for TA-AVI by our interdisciplinary Heart Team and subsequently included in the trial after informed consent was obtained. One patient was excluded due to the presence of deep epicardial fat tissue. In all other cases, the titanium coil provided sufficient sealing throughout the procedure without the presence of perisheath bleeding. After delivery of the closure cap, no relevant bleeding was observed in any patient. Pericardial drainages were removed early in all patients. One patient suffered from non-device-related pericardial effusion requiring surgical decompression on postoperative day 6. Two patients suffered from delayed minor strokes, most likely due to arrhythmia. All patients received aspirin, clopidogrel and low molecular heparin after the procedure. Discharge echocardiography revealed no changes in left ventricular function when compared with baseline and no new onset wall motion abnormalities. All 10 patients were alive at 30 days. CONCLUSIONS TA access and closure are both feasible and safe using the APICA ASC™ device. The system facilitates and standardizes TA access and closure by providing a sufficient and secure sealing during and after the TA-AVI procedure. [ABSTRACT FROM PUBLISHER]

OBJECTIVE Patients undergoing transapical aortic valve implantation (TA-AVI) are usually over 80 years old and have a high prevalence of chronic kidney disease. However, transcatheter valve therapies require the use of contrast injections with the risk of nephrotoxicity. The aim of this study was to evaluate post-operative kidney function and survival in patients with pre-existing renal impairment with regard to the amount of contrast media used during TA-AVI. METHODS From January 2008 to March 2011, 50 patients (52% females, mean age 80.7 ± 5.3 years) with a serum creatinine level of >1.3 mg/dl were investigated. Patients receiving a dose of <100 ml of a contrast agent (low-dose group, n = 24) were separated from those who received >100 ml of a contrast agent (high-dose group, n = 26). An acute contrast-induced nephropathy (CIN) was defined as a serum creatinine increase of 0.5 mg/dl or by >25% of a baseline value within 48 h from contrast medium administration. Patients in both groups had similar characteristics in terms of age, sex, body mass index and comorbidities. RESULTS The median pre-contrast creatinine was 1.67 (1.37–1.83) mg/dl in the low-dose group and 1.51 (1.26–1.98) mg/dl in the high-dose group (P = 0.76). The post-contrast creatinine at 48 h was 1.53 (1.33–2.05) and 2.29 (1.67–2.86) mg/dl in the groups receiving low- and high-dose contrast agents, respectively (P = 0.007). CIN occurred in 41.7% (n = 10) of patients in the low-dose contrast group and in 69.2% (n = 18) in the high-dose contrast group (P = 0.046). Haemodialysis is necessary for 16.7% of the low-dose group and 38.5% of the high-dose group (P = 0.12). Trends towards longer intensive care unit and hospital stay were seen in patients with an extensive use of contrast media [4.3 (2.5–6.5) vs. 5 (3–7.8) days and 12 (9–14.3) vs. 13 (9–18) days, P = 0.091 vs. P = 0.546, respectively]. Regarding death, 3-month and 3-year mortality were significantly higher in the high-dose group (8.3 vs. 30.8%, P = 0.036 and 25 vs. 61.5%, P = 0.004, respectively). CONCLUSIONS Our results indicate a possible association between higher CIN and mortality rate and the extensive use of contrast media during TA-AVI among high-risk patients with pre-existing renal impairment. [ABSTRACT FROM AUTHOR]

Standard surgical aortic valve replacement with a biological prosthesis remains the treatment of choice for low- and mid-risk elderly patients (traditionally >65 years of age) suffering from severe symptomatic aortic valve stenosis or insufficiency, and for young patients with formal contraindications to long-lasting anticoagulation. Unfortunately, despite the fact that several technical improvements have noticeably improved the resistance of pericardial and bovine bioprostheses to leaflet calcifications and ruptures, the risk of early valve failure with rapid degeneration still exists, especially for patients under haemodialysis and for patients <60 years of age at the time of surgery. Until now, redo open heart surgery under cardiopulmonary bypass and on cardioplegic arrest was the only available therapeutic option in case of bioprosthesis degeneration, but it carried a higher surgical risk when elderly patients with severe concomitant comorbidities were concerned. Since a few years, the advent of new transcatheter aortic valve procedures has opened new horizons in cardiac surgery and, in particular, the possibility of implanting stented valves within the degenerated stented bioprosthesis, the so-called ‘valve-in-valve’ (VinV) concept, has become a clinical practice in experienced cardiac centres. The VinV procedure represents a minimally invasive approach dedicated to high-risk redo patients, and published preliminary reports have shown a success rate of 100% with absence of significant valvular leaks, acceptable transvalvular gradients and low complication rate. However, this procedure is not riskless and the most important concerns are about the size mismatch and the right positioning within the degenerated bioprosthesis. In this article, we review the limited available literature about VinV procedures, underline important technical details for the positioning and provide guidelines to prevent valve–prosthesis mismatch comparing the three sizes of the only commercially available transapical device, the Edwards Sapien™, with the inner diameter of three of the most commonly used stented bioprostheses. [ABSTRACT FROM AUTHOR]

Abstract: Objective: Transcatheter aortic valve implantation is a new method for the treatment of very-high-risk patients with aortic valve stenosis. Particularly in patients who have had previous cardiac surgery, the operative risk can be reduced. Nevertheless, this new procedure has some potential risks in these patients, due to the increased danger of endocarditis and in view of potential graft damage after previous bypass grafting or prosthesis damage after previous valve replacement, caused by wire manipulation or valve liberation. Methods: Between April 2008 and January 2010, 198 consecutive patients underwent transapical aortic valve implantation. Group A consisted of 158 patients without previous heart surgery and group B had 40 patients with previous heart operation (23 coronary artery bypass grafting, three aortic valve replacements, two mitral valve repairs, one replacement, and 11 combined operations). Although patients in group B (75±11) were significantly younger than the ones in group A (80±8) (p =0.003), the preoperative risk score was significantly higher in group B (group A – the European System for Cardiac Operative Risk Evaluation (EuroSCORE): 37±18%; the Society of Thoracic Surgeons (STS) mortality score: 21±16; group B – EuroSCORE: 53±21%; STS mortality score: 29±18) (p <0.001, p =0.006). Results: The technical success rate was 99.5% (157/158) in group A and 100% (40/40) in group B. One patient in group A developed an annulus rupture. The postoperative echocardiographic examinations showed low transvalvular gradient due to the special design of the valve, without differences between the two groups. The 30-day mortality was 6.9% in group A and 5.0% in group B, and the 1-year survival was 77% and 74% in group A and group B, respectively (nonsignificant). Conclusions: Transcatheter valve implantation can be performed successfully after previous heart surgery. Particular care should be taken to achieve optimal valve position and not to damage grafts or prosthetic valves during manipulation with guide wires or valve positioning. [Copyright &y& Elsevier]

Aims The Medtronic Engager™ aortic valve bioprosthesis is a self-expanding valve with support arms facilitating anatomically correct positioning and axial fixation. Valve leaflets, made of bovine pericardium, are mounted on a Nitinol frame. Here, we report the first in man study with this new implant (Trial Identifier NCT00677638). Methods and results Thirty patients (mean age 83.4 ± 3.8 years; 83% female) with tricuspid aortic valve stenosis were included in the study. Mean logistic EuroSCORE was 23.4 ± 11.9. Mean aortic annulus diameter was 21.8 ± 1.4 mm. For this study, the Engager was available in only one size (23 mm), to fit aortic annuli of 19–23 mm. Standard transapical valve implantation was performed using predilation of the aortic valve and rapid ventricular pacing during ballon valvuloplasty and most valve deployments. Accurate valve placement was achieved in 29/30 cases (97%). Post-implant peak-to-peak gradient was 13.3 ± 9.3 mmHg. In 80% of the patients, no more than grade I paravalvular leakage was observed, in 13% grades I–II and in 3% grade II. Three patients (10%) required permanent pacemaker implantation for higher-degree or complete atrioventricular block. Four dissections (13%) occurred during positioning of the valve and were treated surgically in three cases. Thirty-day and in-hospital mortality were 20% and 23%, respectively, and 6-month survival was 56.7%. No structural failure occurred for up to 1 year. Conclusion This series established the feasibility of implanting a novel self-expanding transapical aortic valve prosthesis predictably into an anatomically correct position. Observed complications led to complete redesign of the delivery system for upcoming clinical studies with the goal of establishing safety and performance. [ABSTRACT FROM PUBLISHER]

Abstract: Objective: To evaluate the feasibility of minimally invasive transapical beating heart aortic valve implantation (TAP-AVI) for high-risk patients with aortic stenosis. Methods: TAP-AVI was performed via a small anterolateral minithoracotomy in 50 patients from February 2006 to March 2007. A balloon expandable transcatheter xenograft (Edwards SAPIEN™ THV, Edwards Lifesciences, Irvine, CA, USA) was used. Mean age was 82.4±5 years and 39 (78%) were female. Implantation was performed in a hybrid operative theatre using fluoroscopic and echocardiographic visualization. Average EuroSCORE predicted risk for mortality was 27.6±12%. Seven (14%) patients were re-operations with patent bypass grafts. Results: TAP-AVI (13 patients 23mm and 37 patients 26mm) was successfully performed on the beating heart under temporary rapid ventricular pacing in 47 (94%) patients, and implantation was performed completely off-pump in 34 (68%) patients. Three patients required early conversion; two of them were successfully discharged. There was no prosthesis migration or embolization observed. Echocardiography revealed good hemodynamic function in all and minor incompetence in 23 patients, mostly paravalvular, without any signs of hemolysis. Mortality was due to the overall health condition and non-valve related in all patients. Actuarial survival at 1 month, 6 months and 1 year was 92±3.8%, 73.9±6.2% and 71.4±6.5%, respectively. Conclusions: Transapical minimally invasive aortic valve implantation is feasible using an off-pump technique. Good results have been achieved in the initial 50 patients, especially when considering the overall high-risk profile of these patients. [Copyright &y& Elsevier]

Abstract: Objective: To evaluate the feasibility of minimally invasive transapical beating heart aortic valve implantation (TAP-AVI) for high-risk patients with aortic stenosis. Methods: TAP-AVI was performed via a small anterolateral minithoracotomy with or without femoral extracorporeal circulation (ECC) on the beating heart. A pericardial xenograft fixed within a stainless steel, balloon expandable stent (Cribier-Edwards, Edwards Lifesciences, Irvine, CA, USA) was used. Thirty consecutive patients (82±5.1 years, 21 (70%) female) were operated from 02/06 until 09/06 at one center using fluoroscopic and echocardiographic visualization. Average EuroSCORE predicted risk for mortality was 27±12%. Results: Valve positioning was successful in 29 patients and one required early conversion to full sternotomy. Implantation (8mm×23mm and 22mm×26mm valves) was performed on the beating heart during brief periods of rapid ventricular pacing. ECC was applied in 13 patients. Neither coronary artery obstruction nor migration of the prosthesis was observed and all valves displayed good hemodynamic function. Echocardiography revealed minor paravalvular leakage in 14 patients (trace in three, mild in nine and moderate in two). Three patients (10%) died, one on postoperative day (POD) three secondary to preoperative global myocardial failure and two on POD 18 and 86 due to abdominal complications. Conclusions: Minimally invasive beating heart TAP-AVI is feasible. Initial results are encouraging in view of the high-risk profile of the patients. Long-term studies as well as randomized protocols are required. [Copyright &y& Elsevier]

A response from the authors of the article about transcatheter aortic valve and aortic homograft reintervention that was published in the previous issue is presented.