Transarterial Aortic Valve Implantation Research Articles

Blood flow pattern in the ascending aorta after TAVI and conventional aortic valve replacement: Analysis using 4D-Flow MRI

Background Transarterial aortic valve implantation (TAVI) is a valid alternative to treat aortic stenosis in patients with high surgical risk. The impact of TAVI on changes in blood flow dynamics in the ascending aorta has not been systematically analyzed. Using temporally resolved, three-dimensional, phase contrast MRI (4D-flow), we studied 3D hemodynamics in the ascending aorta (AAo) after TAVI and compared the results to patients with conventional aortic valve replacement (AVR) as well as healthy controls.

Concomitant surgery during ventricular assist device implantation.

Today, ventricular assist device (VAD) implantation is an established treatment for end-stage heart failure. However, there are various cardiovascular pathologies that require concomitant treatments during surgical VAD implantation, which may render the procedure difficult or compromise VAD function. Furthermore, there are certain clinical situations that prohibit VAD implantation (1,2). Aortic valve regurgitation or the presence of a mechanical aortic valve prosthesis are relative contraindications for implantation of left ventricular assist devices (LVADs). In such cases, one option is to undertake concomitant aortic valve replacement with a biological prosthesis. In stable patients, simultaneous aortic valve replacement and LVAD implantation are not associated with a poorer outcome. However, in patients with cardiogenic shock, concomitant aortic valve replacement may impair outcomes, and therefore alternative techniques should be considered (3). In the case of significant aortic regurgitation causing a progressive increase in left ventricular diameter which cannot be compensated by increased pump output, two options are available. Firstly, a transplant candidate may be shifted to a high-urgency status on the waiting list, and secondly, conventional aortic valve replacement can be considered for patients who require permanent VAD support. New catheter-based technologies, such as transarterial aortic valve implantation or closure of aortic valves by devices similar to those used for septal defect closure, should first be evaluated in an experimental setting. Mitral stenosis must be corrected during LVAD implantation, as the presence of a mitral valve prosthesis (mechanical or biological) is not a contraindication for LVAD placement. The presence of pulmonary artery thrombi in patients scheduled for LVAD implantation significantly increases the risk of postoperative right ventricular failure (RVF). Right ventricular assist device (RVAD) support may be useful in isolated RVF after embolectomy and RVF following LVAD insertion (4). Patients with active systemic infections should not be considered for LVAD support, as infection is a leading cause of morbidity and mortality. Implantation should be delayed for patients with localized infections that can be effectively treated, if clinically feasible. Type A acute aortic dissection (AAD) is a life-threatening emergency that carries a high mortality rate without surgical treatment. Surgical outcomes of AAD have been improving with increasing experience and advances in diagnosis, surgical techniques and perioperative management. However, there continues to be individuals who require mechanical assistance immediately after life-saving surgery as a result of terminal heart failure following AAD. VAD or total artificial heart (TAH) therapy are feasible options for individuals who suffer from AAD and have undergone surgical treatment. Assessment of patients’ clinical status (severity of shock and coagulopathy) and right ventricular function is paramount in the selection of an appropriate therapy (TAH vs. biventricular assist device vs. LVAD). VAD implantation may also be part of the treatment for end-stage heart failure in adults with complex congenital heart defects (CHDs). These patients are managed by a collaborative team of specialists [pediatric surgeon, mechanical circulatory support (MCS) surgeon, MCS cardiologist, and VAD coordinator], who have a clear understanding of cardiovascular anatomy, pathophysiology of specific heart defects and additional risks incurred with surgery. The team must also be able to effectively evaluate the risk of biventricular versus univentricular failure, the suitability of device types and configurations for different forms of CHD and individual anticoagulation management (5). In patients with previous or repeated sternotomies, we prefer the left lateral thoracotomy approach when the goal is to achieve permanent assist device support. Special consideration must be given to factors such as old age, severity of cardiogenic shock, and multi-organ failure, where additional procedures may likely increase the risks of LVAD implantation. Video Concomitant surgery during ventricular assist device implantation.

Impact of Gender on Three-Month Outcome and Left Ventricular Remodeling After Transfemoral Transcatheter Aortic Valve Implantation

Transarterial aortic valve implantation (TAVI) is a promising method for the treatment of high-risk patients with aortic stenosis. Because gender differences are known in aortic stenosis, the aim of this study was to compare procedural and short-term outcomes, left ventricular remodeling, and inflammatory status after TAVI in men and women. One hundred consecutive patients (42 men, 58 women) who underwent transfemoral TAVI (CoreValve in 83%, SAPIEN in 17%) were prospectively analyzed. Aortic stenosis severity was higher in women (mean valve area 0.7 ± 0.3 vs 0.8 ± 0.2 cm(2)). Women had better ejection fractions, smaller end-diastolic and end-systolic diameters, and more concentric hypertrophy at baseline. There were no differences in device success rate (99%), 30-day total mortality (2.4% in men, 3.4% in women), stroke (2.4% in men, 1.7% in women), or pacemaker rate (26.2% in men, 15.5% in women). Periprocedural complications and 3-month outcome were not different between the genders. After TAVI, regression of hypertrophy occurred in men and women, but improvement of the ejection fraction was significant only in women. N-terminal pro-B-type natriuretic peptide decreased to similar levels in the 2 genders. C-reactive protein and interleukin-6, elevated at baseline more in men than in women, decreased after TAVI and normalized at 3 months only in women. In conclusion, women clinically benefit from TAVI to a degree similar to that of men. However, there are gender differences involving the recovery response of the left ventricle after TAVI.

Transcutaneous Aortic Valve Implantation Using the Left Carotid Access: Feasibility and Early Clinical Outcomes

In some patients, transfemoral, transaxillary, or transapical aortic valve implantation is not possible. Thus, carotid artery access may represent a safe alternative to those accesses, and even offers certain advantages. In this article, we describe aortic valve implantation using the left carotid arterial approach and report our initial experience. Using a self-expandable nitinol based device (CoreValve ReValving system, Medtronic Ltd, Luxembourg), we exposed the left carotid artery through a small incision. Arterial puncture and initial 6F sheath introduction were achieved through a contraincision. The same implantation technique as for transaxillary implantation was used. Progressive artery dilatation was achieved using sheaths of increasing diameter. Rapid ventricular pacing was used to reduce cardiac output while performing a routine aortic balloon valvuloplasty. Only then, an 18F sheath was inserted into the carotid artery and pushed down into the ascending aorta. The patients were monitored using cerebral oxymetry to assess cerebral perfusion. Twelve consecutive patients, at high surgical risk, were implanted and studied prospectively. Transfemoral and subclavian catheterization were considered unfeasible or at risk of severe complications. Carotid arterial injury did not occur in any patient. A transient ischemic attack occurred in 1 patient, contralateral to the carotid access. There were no deaths in either intraprocedural or during the 30-day follow-up period. This initial experience suggests that left carotid transarterial aortic valve implantation, in selected high-risk patients, is feasible and safe with satisfactory short-term outcomes.

Transcutaneous aortic valve implantation using the axillary/subclavian access with patent left internal thoracic artery to left anterior descending artery: Feasibility and early clinical outcomes

Both retrograde femoral and subclavian artery catheterization techniques have been described as the most common methods for the implantation of the Medtronic CoreValve percutaneous aortic valve (Medtronic Inc, Minneapolis, Minn). The subclavian artery has been shown to be a safe and effective alternative access route in patients with unfavorable femoral access. Of the patients who are identified as candidates for subclavian artery access, a subset possess a patent left internal thoracic artery to left anterior descending artery. This patent left internal thoracic artery presents an additional anatomic and clinical variable that must be taken into consideration to ensure procedural safety and efficacy. We describe the Medtronic CoreValve percutaneous aortic valve implantation using the subclavian arterial approach in patients with a patent left internal thoracic artery and report our study's findings. The CoreValve percutaneous aortic valve is a self-expandable nitinol-based frame with a porcine pericardial valve. The subclavian access was created by a small infraclavicular surgical incision to expose the artery. Rapid ventricular pacing was used to reduce cardiac output to perform the balloon aortic valvuloplasty via a 12F sheath inserted into the subclavian artery. An 18F sheath was then inserted into the artery down into the ascending aorta and used for introduction of the delivery catheter and implantation of the percutaneous aortic valve. With the use of this method, 19 patients (76 ± 13 years) whose surgical risk was deemed excessive because of severe comorbidity and in whom transfemoral catheterization was considered unfeasible or at risk of severe complications have received implants. Subclavian artery or left internal thoracic artery injury did not occur in any patient. Two deaths occurred. One patient died of right coronary artery occlusion during the procedure, and one patient died 48 hours after the procedure as the result of a tamponade after the temporary pacemaker wire ablation. This initial experience suggests that subclavian transarterial aortic valve implantation in patients with a patent left internal thoracic artery to left anterior descending artery is feasible and safe with satisfactory short-term outcomes.

Invited Commentary

Although not a surprise for a number of reasons, Motloch and colleagues' [1] finding of an abated risk of periprocedural atrial fibrillation (AF) after transarterial aortic valve implantation (TAVI) is an interesting confirmation. In fact, even though the risk that new AF episodes will develop is much higher after conventional open aortic valve replacement (AVR), recently published evidence shows that central nervous system embolic complications appear to occur much more frequently after endovascular procedures.

Real-time MR-guided transarterial aortic valve implantation (tavi): in vivo evaluation in swine

Transcatheter, transarterial aortic valve implantation (TAVI) is rapidly emerging as a promising new treatment option for patients with severe symptomatic aortic valve stenosis who are considered at high or prohibitive surgical risk [1,2]. Envisioning real-time MR guidance of the TAVI procedure, the objective of this study was the systematical

Transcatheter Aortic Valve Implantation in the Era After Commercialization

Transcatheter, transarterial aortic valve implantation (TAVI) is a revolutionary approach for the treatment of aortic valve stenosis, a lingering but malignant disease characterized by a long, symptom-free latency period but a high rate of death after the onset of symptoms.1,2 Introduced only recently in 2002,3 TAVI has entered the clinical arena in an unprecedented fashion. Offering for the first time a definite, catheter-based treatment option for nonsurgical and high-risk patients with symptomatic severe aortic stenosis, TAVI has been adopted rapidly in Europe despite the absence of data in larger patient populations and the lack of randomized studies. Initial first-in-humans feasibility and safety studies had been conducted by expert operators in highly specialized centers and selected patient groups in Europe and Canada that demonstrated a remarkable clinical success, but also unanticipated problems.4,–,7 However, the significant clinical benefit in the high-risk elderly patient population, for whom few options were available previously, led to a unique dissemination of TAVI, especially after Conformite Europeenne (CE) approval of the balloon-expandable Edwards SAPIEN (Edwards Lifesciences Inc, Irvine, CA) and the self-expandable Medtronic CoreValve (Medtronic, Inc, Minneapolis, MN) prosthesis in 2007. To date, more than 10 000 TAVI procedures have been performed worldwide with these devices, and the number of procedures is increasing continuously. Article see p 299 With this transfer into the real world, the value of TAVI in daily clinical practice now must be demonstrated. Randomized controlled clinical trials are the “gold standard” for evaluation of treatment effectiveness, providing the highest-quality data and evidence. The Placement of Aortic Transcatheter Valves (PARTNER) trial,8 conducted mainly at US centers, is the first prospective, multicenter, randomized controlled clinical trial in the setting of TAVI to evaluate the safety and effectiveness of transfemoral and transapical TAVI with the SAPIEN …

Percutaneous transarterial aortic valve implantation: what do we know?

Transcatheter aortic valve implantation (TAVI) is assuming a major role in the routine management of patients with aortic stenosis. Surgical aortic valve replacement is generally accepted to prolong survival, on the basis of historical comparisons and long experience. However, recently percutaneous transarterial TAVI has assumed the position as the only therapy in any aortic stenosis patient group demonstrated to prolong survival in a randomized trial. Arguably, percutaneous TAVI is now the standard of care in symptomatic patients who are not candidates for conventional surgery. On the basis of almost 10 years of experience TAVI also appears to be a reasonable option for some operable, but high-risk patients. Nevertheless considerable work needs to be done before the indications for TAVI are expanded into lower risk groups. We review what is currently known about percutaneous transarterial implantation of the aortic valve.

Transcutaneous aortic valve implantation using the axillary/subclavian access: Feasibility and early clinical outcomes

Retrograde transfemoral artery catheterization is the most common way of implanting a percutaneous aortic valve. But in some cases, this access cannot be used and the subclavian artery access may represent an alternative to the femoral route, even offering certain advantages. This article describes prosthetic aortic valve implantation using the subclavian arterial approach and reports the findings. The valve prosthesis is a self-expandable, nitinol-based device (CoreValve; Medtronic Inc. Minneapolis, Minn). The axillary or subclavian artery was exposed with a small incision. Rapid ventricular pacing was used to reduce cardiac output while a routine aortic balloon valvuloplasty was performed. Then, an 18F sheath was inserted into the axillary artery down into the ascending aorta. By using this method, a prosthesis was implanted in 17 patients (aged 71±11 years) whose surgical risk was deemed excessive because of severe comorbidity and in whom transfemoral catheterization was considered unfeasible or at risk of severe complications. Subclavian arterial injury did not occur in any patient. The postprocedural aortic valve area increased from 0.6±0.3 cm2 to 1.44±0.35 cm2. A transient ischemic attack occurred in 1 patient. Two patients experienced transitory brachial plexus deficit. There were no intraprocedural deaths. Two deaths occurred in the 30-day follow-up period. This initial experience suggests that subclavian transarterial aortic valve implantation, in selected high-risk patients, is feasible and safe with satisfactory short-term outcomes.

Thirty-day outcome and vascular complications after transarterial aortic valve implantation using both Edwards Sapien™ and Medtronic CoreValve® bioprostheses in a mixed population

Transcatheter aortic valve implantation (TAVI) is performed through a transarterial approach with encouraging results in "one-type valve" registries. We report 30-day data from a mixed population of patients treated with either Medtronic CoreValve (MCV) or Edwards SAPIEN (ES) valves. Forty-five patients had TAVI via the transarterial approach (21 MCV and 24 ES). Mean age was 81.8+/-4.2 years, Logistic EuroSCORE was 25.2+/-8.4%. Procedural success rate was 97.8%. In-hospital death rate was 4.4%. Vascular complication rate was 8.9%. Of MCV patients, 28.6% had a permanent pacemaker vs. 4.2% of ES patients; p=0.02. No additional deaths were observed between discharge and 30 days. NYHA functional class was improved at 30-days: 2.07+/-0.4 vs. 3.09+/-0.05, p<0.0001. Mean transvalvular gradient was lower: 9.5+/-3.28 mmHg vs. 41.9+/-14 mmHg, p<0.0001. Overall 30-day MACE rate was 8.9%, similar between MCV and ES patients. A routine policy of TAVI using both MCV and ES valves is feasible without any worsening of procedural success rates and 30-day outcomes. A wider population of high risk patients with aortic stenosis can be offered a transarterial treatment. This could be the next standard of care for teams performing TAVI.

Transapical implantation of a self-expanding aortic valve bioprosthesis — animal feasibility study☆

Severe peripheral arterial disease may pose a limitation to the applicability of trans-arterial aortic valve implantation in patients who are otherwise candidates. For this reason, transapical aortic valve implantation has been proposed as a possible alternative. To evaluate the acute safety and performance of a specially designed delivery system, the CoreValve Tranzap delivery catheter, for the transapical implantation of a self-expandable aortic valve prosthesis in a porcine animal model. Thirteen pigs were implanted with a self-expandable aortic valve bioprosthesis using a 21F catheter delivery system through a transapical approach. The delivery system was evaluated for: (1) the ability to access the implantation site; (2) the ability to precisely position the delivery catheter; (3) control of the delivery of the prosthesis; (4) safe retrieval of the delivery catheter; and (5) the ability to close the apical access site of the heart. Successful implantation was achieved in 100% of the cases. The following points were achieved in all animals: (1) passage of the delivery catheter through an incision in the left ventricular apex; (2) positioning of the delivery catheter on the implantation site; (3) controlled deployment of the aortic valve prosthesis; (4) the safe retrieval of the delivery catheter system; and (5) the adequate closure of the apex of the heart. This study demonstrates the acute safety and feasibility of the CoreValve Tranzap delivery system for the transapical implantation of the CoreValve self-expanding aortic valve bioprosthesis in a porcine animal model.

Survival after transapical and transarterial aortic valve implantation: Talking about two different patient populations

Survival after transapical and transarterial aortic valve implantation: Talking about two different patient populations

Percutaneous retrograde transarterial aortic valve implantation successful

Percutaneous retrograde transarterial aortic valve implantation successful

Percutaneous Aortic Valve Implantation Retrograde From the Femoral Artery

Percutaneous aortic valve implantation by an antegrade transvenous approach has been described but is problematic. Retrograde prosthetic aortic valve implantation via the femoral artery has potential advantages. Percutaneous prosthetic aortic valve implantation via the femoral arterial approach is described and the initial experience reported. The valve prosthesis is constructed from a stainless steel stent with an attached trileaflet equine pericardial valve and a fabric cuff. After routine aortic balloon valvuloplasty, a 22F or 24F sheath is advanced from the femoral artery to the aorta. A steerable, deflectable catheter facilitates manipulation of the prosthesis around the aortic arch and through the stenotic valve. Rapid ventricular pacing is used to reduce cardiac output while the delivery balloon is inflated to deploy the prosthesis within the annulus. Percutaneous aortic prosthetic valve implantation was attempted in 18 patients (aged 81+/-6 years) in whom surgical risk was deemed excessive because of comorbidities. Iliac arterial injury, seen in the first 2 patients, did not recur after improvement in screening and access site management. Implantation was successful in 14 patients. After successful implantation, the aortic valve area increased from 0.6+/-0.2 to 1.6+/-0.4 cm2. There were no intraprocedural deaths. At follow-up of 75+/-55 days, 16 patients (89%) remained alive. This initial experience suggests that percutaneous transarterial aortic valve implantation is feasible in selected high-risk patients with satisfactory short-term outcomes.