Arnaud Van Linden

Transapical Aortic Valve Implantation

Background— Transapical aortic valve implantation has evolved to a reproducible therapeutic option for high-risk patients. The aim of the present study was to evaluate our learning experience over 4 years and to analyze outcome-related risk factors. Methods and Results— A total of 299 patients who received transapical aortic valve implantation between February 2006 and January 2010 with the Edwards SAPIEN transcatheter prosthesis were analyzed according to early experience (EE; patients 1 to 150) and recent experience (RE; patients 151 to 299). Patients consistently demonstrated high risk scores, and major perioperative parameters were comparable between the 2 groups. RE patients had a significantly higher logistic EuroSCORE (RE 33.2±17.2, EE 29.4±14; P=0.039) but a significantly lower STS (Society of Thoracic Surgeons) score (RE 11.4±7.5, EE 13.5±7.8; P=0.019). Use of contrast dye (EE 104±78 mL, RE 93±46 mL) and the need to perform a balloon redilation were significantly reduced in the RE group. Thirty-day mortality decreased from 11.3% to 6.0%, and 1-year mortality improved significantly from 30.7% (EE) to 21.5% in the RE patients (P=0.047). Multivariate logistic regression analysis revealed reduced vital capacity (<70%) and concomitant preoperative mitral regurgitation >1+ as the only independent predictors of 30-day mortality. Classic variables such as age, logistic EuroSCORE >30%, and STS score >15% failed to predict mortality. Conclusions— Recent results with transapical aortic valve implantation indicate a progressive improvement in outcomes despite an unchanged patient risk profile, which reflects a significant learning curve that includes a better understanding of optimal patient selection. Classic surgical risk factors fail to predict outcome, which indicates the need for new transapical aortic valve implantation–specific risk scores.

Risk of acute kidney injury after minimally invasive transapical aortic valve implantation in 270 patients

OBJECTIVE Contrast agent is a potential risk factor for acute kidney injury (AKI). Little is known about the incidence of contrast-induced nephropathy (CIN) after trans-apical aortic valve implantation (TA-AVI) and on the impact of contrast exposure during preoperative computed tomography (CT) scan and cardiac catheterization. METHODS A total of 270 consecutive high-risk patients received TA-AVI for symptomatic aortic valve stenosis during a 3-year period. Different preoperative, peri-procedural, and postoperative variables were analyzed by uni- and multivariate logistic regression concerning incidence of early (<7 days) AKI and need for renal replacement therapy (RRT). Nine patients on chronic preoperative dialysis were excluded. RESULTS Mean age was 82 ± 5.8 years, 71% were female. LogEuroSCORE (European System for Cardiac Operative Risk Evaluation) and STS Score were 31.4 ± 15.6% and 12.1 ± 7.4%, respectively. Preoperative estimated glomerular filtration rate (eGFR) <60 ml min(-1) was present in 35.2%. CT scan and cardiac catheterization within 7 days before TA-AVI were performed in 43.7% and 20.3% of the patients and were associated with a mean contrast-agent exposition of 110 ± 21 ml for CT scans and 91 ± 65 ml for cardiac catheterization. Regarding the postoperative renal outcome, an improved or at least stable eGFR was seen in more than 50% of the patients. Intra-operative contrast-agent application was 99 ± 64 ml and correlated significantly to the development of postoperative AKI and need for RRT (p=0.013 and p=0.003). Postoperative RRT was required in 15.7%. Chronic renal insufficiency (odds ratio (OR)=6.8, p=0.025) and number of blood transfusions (OR=8.8, p=0.009) were independent risk factors for RRT. Postoperative AKI occurred in 16.1% and intra-operative contrast-agent burden >99 ml (OR=2.3, p=0.038), new thrombocytopenia (OR=4.4, p=0.005) and pathological leucocyte count (OR=2.8, p=0.009) were independent risk factors for this event. Early (within 1-7 days before TA-AVI) preoperative CT and cardiac catheterization did not significantly increase incidence of RRT or AKI. Short-term and long-term survival was explicitly lower in the AKI and in the RRT groups (p<0.001 each). CONCLUSIONS GFR improves after TA-AVI. Postoperative AKI and RRT depend on the amount of intra-operative contrast agent. These results strongly support the need for intra-operative tools to reduce contrast-agent exposition during TA-AVI.

Transapical Off-Pump Valve-in-Valve Implantation in Patients With Degenerated Aortic Xenografts

BACKGROUND The reoperative risk for degenerated aortic valve xenografts may be increased in elderly patients with comorbidities. We evaluated the off-pump beating heart concept of transapical aortic valve implantation using the valve-in-valve (VinV) concept. METHODS Since March 2007, 11 patients with degenerated xenografts received transapical aortic valve implantation using the Edwards Sapien transcatheter heart valve (Edwards Lifesciences, Irvine, CA). After informed consent, all procedures were performed as an off-label use. Mean patient age was 78 +/- 6 years (range, 72 to 89), mean logistic European System for Cardiac Operative Risk Evaluation was 32% +/- 16% (range, 16% to 62%) and mean Society for Thoracic Surgeons score was 7% +/- 3% (range, 3% to 10%). RESULTS All patients were treated off pump. The transapical aortic valve implantation was successful in all patients, and apical access was uncomplicated in all of them. Total operating room time was 71 +/- 14 minutes. On postoperative echocardiography, there was no paravalvular incompetence in any and mild (first degree) central incompetence in 2 of 11 patients. Sufficient flaring of the inflow and outflow parts of the Sapien prosthesis was observed in all patients, suggesting a stable position and an almost absent risk of late embolization. Maximal transvalvular pressure gradients were 21 +/- 8 mm Hg, and mean echocardiographic pressure gradients were 11 +/- 4 mm Hg. Follow-up extends to 330 +/- 293 days (range, 15 to 1,007), and all patients are well and alive. CONCLUSIONS Valve-in-valve implantation is a truly minimally invasive procedure for redo treatment of failed aortic valve xenografts in high-risk elderly patients. The Edwards Sapien valve is well suited for VinV implantation, and this technique may become a routine procedure to treat degenerated xenografts in the future.

Transapical Aortic Valve Implantation: Therapy of Choice for Patients With Aortic Stenosis and Porcelain Aorta?

BACKGROUND Conventional aortic valve replacement can be technically challenging in patients with porcelain aorta and is associated with a high rate of stroke and mortality. Porcelain aorta is even sometimes seen as contraindication for surgery. Minimally invasive off-pump transapical aortic valve implantation may be an optimal strategy to treat elderly patients with porcelain aorta requiring aortic valve replacement. METHODS Twenty-nine patients with severe aortic stenosis and porcelain aorta underwent transapical aortic valve implantation. Mean age was 79 ± 7.8 years (range, 64 to 93 years), with 65.5% female. Logistic EuroSCORE and the Society of Thoracic Surgeons score were 37.7% ± 18.1% and 12.8% ± 2.2%, respectively. Peripheral vascular disease (41.4%) and carotid artery stenosis (58.6%) were frequent, and 17.2% of patients had experienced a stroke previously. The majority of patients were redo cases (51.2%), and 10.3% were dependent on chronic hemodialysis. In 13.8% of all patients, intraoperatively detected porcelain aorta caused an attempt at conventional aortic valve replacement by means of sternotomy to be aborted. RESULTS All valves were implanted successfully without embolization or aortic dissection. All procedures were primarily performed off-pump, but 4 patients required secondary cardiopulmonary bypass as a result of complications. Median procedure time was 80 minutes, and median intensive care unit stay was 1 day. Stroke occurred in 1 patient only. Thirty-day mortality was 17.2%. Mild paravalvular leak was seen in 31.0%, and mild to moderate regurgitation occurred in 1 patient. CONCLUSIONS Transapical aortic valve implantation is a promising approach to treat elderly patients with porcelain aorta requiring aortic valve replacement. It is associated with acceptable outcome and low stroke rates.

Transfemoral Aortic Valve Implantation of Edwards SAPIEN XT Without Predilatation Is Feasible

Transcatheter aortic valve implantation (TAVI) without predilatation has fewer procedural steps and thereby potentially fewer complications. This has been demonstrated for the antegrade transapical access; however, whether TAVI can be safely performed without predilatation using the retrograde transfemoral route is unknown.

Contemporary management of aortic stenosis: surgical aortic valve replacement remains the gold standard

Aortic valve disease is the most frequent acquired heart valve lesion in humans. In western communities, approximately 90% of patients present with aortic stenosis (AS), predominantly of a calcific degenerative aetiology. The remaining approximately 10% of patients predominantly present with aortic valve incompetence.

Detection of Myocardial Injury by CMR After Transcatheter Aortic Valve Replacement

BACKGROUND Myocardial injury after transcatheter aortic valve replacement (TAVR) is common, but its cause and relationship to the extent of myocardial tissue loss remain unclear. OBJECTIVES This study sought to examine the incidence and degree of ischemic myocardial damage using cardiac magnetic resonance imaging and myocardial biomarkers in patients undergoing TAVR. METHODS Patients with severe aortic stenosis (n = 61) underwent cardiac magnetic resonance imaging before and after TAVR for the assessment of new myocardial injury. High-sensitivity cardiac troponin T and creatine kinase-myocardial band were measured before and at 24, 48, and 72 h after TAVR. RESULTS After TAVR, new myocardial late enhancement (LE) with an ischemic pattern occurred in 11 patients (18%), with a mean mass of 3.7 g (interquartile range: 1.2 to 6 g) or 1.8% (interquartile range: 1.3% to 4.1%) of the left ventricular mass. Patients with new LE had a decreased left ventricular function (ejection fraction: pre, 55.5 ± 14.1% vs. post, 45.3 ± 14.9%; p = 0.001). In patients without new LE, no differences were observed (ejection fraction: pre, 53.9 ± 17.3% vs. post, 54.6 ± 16.3%; p = NS) after TAVR. CONCLUSIONS New ischemic-type myocardial LE after TAVR can be observed in a notable proportion of patients and is assumed to be of embolic origin. Patients with new LE feature a significant decrease in left ventricular function at discharge.

First-in-man evaluation of the transapical APICA ASC™ access and closure device: the initial 10 patients

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.

First experience without pre-ballooning in transapical aortic valve implantation: a propensity score-matched analysis

OBJECTIVES Transapical aortic valve implantation (TA-AVI) using the Edwards SAPIEN™ prosthesis has evolved into a routine procedure for selected high-risk elderly patients. The recently introduced SAPIEN™ delivery system (Ascendra II+™) with an added nose cone seems to facilitate direct valve implantation without prior balloon valvuloplasty (BAV). Here, we report our initial experience with this device. METHODS A total of 128 patients were enrolled in the study in 2012 and 2013 and were designated Cohort I. For a subset of 79 patients, exact cardio- computed tomography-based measurements were available; these patients were assigned to Cohort II. All patients received SAPIEN XT™ valves using the TA approach. TA-AVI without pre-ballooning was performed in 31.2% (Cohort I) and 31.6% (Cohort II) of patients. To adjust for baseline variables, propensity score (PS)-based pair matching was used. RESULTS All valves were implanted successfully. The use of PS matching resulted in bias reduction for both cohorts. For Cohort I, there were no significant differences in the primary end points, which were aortic valve incompetence≥2+, Pmean postimplantation, major stroke, transient ischaemic attack (TIA), requirement for post-dilatation and necessity for new pacemaker implantation. As expected, fluoroscopy time was significantly lower in no-BAV patients. In Cohort II, the 30-day TIA rate was lower in the no-BAV group. CONCLUSIONS Direct TA implantation of the SAPIEN valve without pre-ballooning is feasible, safe, does not seem to compromise functional outcomes and may be associated with fewer neurological events.

Transfemoral aortic valve implantation of Edwards SAPIEN 3 without predilatation

The purpose of the present study was to investigate whether transfemoral implantation of the balloon‐expandable Edwards SAPIEN 3 device without prior balloon valvuloplasty is feasible.