Transapical Approach Research Articles

Modified Single-Puncture Technique for Transcatheter Aortic Valve Implantation in Patients without Peripheral Vascular Access.

Transcatheter aortic valve implantation (TAVI) is now routinely performed to treat inoperable and high-risk patients with severe aortic stenosis (AS). Transapical or transaortic approaches are alternative routes used when peripheral accesses are unsuitable.Correct placement of the device is achieved with the help of an angiography performed with a pigtail catheter to identify the deployment view. However, in patients with severe vascular disease, placement of a pigtail catheter may not be possible.We report a modified single-puncture technique, whereby a single access point is used to perform both angiography and TAVI by using visible calcification landmarks as reference points.

The clinical impact of vascular complications as defined by VARC-1 vs. VARC-2 in patients following transcatheter aortic valve implantation.

The Valve Academic Research Consortium (VARC) recommendations were devised to standardise clinical endpoint definitions which best reflect the safety and efficacy of transcatheter aortic valve implantation (TAVI). The categorisation of vascular complications (VC) is greatly affected by the definition, but the impact of its change is unclear. We sought to compare VC between VARC-1 and VARC-2 definitions as a predictor for survival. A series of 376 patients undergoing TAVI by the transfemoral or transapical approach was studied. We defined VC according to VARC-1 and VARC-2, and compared the mortality one year after the procedure. Kaplan-Meier curves showed numerically lower survival rates at one year by major VC with both definitions, but only VARC-2 had statistical significance: 79.3% vs. 60.7% with VARC-2 (p=0.014), and 78.9% vs. 70.5% with VARC-1 (p=0.20). Cox regression multivariable models showed major VC with VARC-2 definition to be an independent predictor of mortality (hazard ratio of 3.0, 95% confidence interval: 1.4-6.6, p=0.006), but not when it was substituted by the VARC-1 definition (p=0.15). The VARC-2 definition of VC offers better predictive value of survival than the VARC-1 definition, supporting its efficacy as a standard definition.

Transcatheter aortic valve replacement: the new era, new opportunity and new challenge of cardiac surgery

Conventional surgical aortic valve replacement is still the current "gold standard" in treatment of aortic valve disease, but part of the high-risk elder patients couldn't tolerate the surgical trauma. Now those people could receive timely and effective treatment with the application of transcatheter aortic valve replacement, and the related guidelines have been published in recent years. With its wide use in recent 10 years, different implantation systems, such as SAPIEN, CoreValve, Lotus, ACURATE neo, have been gradually improved and provened in several large clinical trials. Transfemoral, transapical and transaortic approaches are approved for the access and used according to different indications. Bleeding, vascular events, Ⅲ grade atrioventricular block, coronary obstruction, valve malpositioning, valve degeneration are the major complications for this skill, but would be overcome with the improvement of the system. The transcather aortic valve replacement brings not only the opportunity to develop new treatment protocols, but the challenge for cardiac surgeons to learn new skills to control.

Invited Commentary

Invited Commentary

Transaortic approach for transcatheter aortic valve replacement with other concomitant cardiac procedures in high-risk patients.

The transaortic (TAo) approach has been proposed as an alternative to the transapical approach and can be used in concomitant procedures. We use the TAo transcatheter aortic valve replacement (TAVR) with other simultaneous cardiac procedures in high-risk patients who needed surgical management. Between September 2013 and September 2015, nine consecutive high-risk patients with severe aortic valve stenosis (AR) and combined tricuspid valve disease or coronary artery disease were treated with TAo TAVR and simultaneous tricuspid valve repair or coronary artery bypass grafting. Mean postoperative pressure gradient at discharge was 13.4 ± 3.2 mmHg and AR grade >2/4 was observed in one case (11.1%). New pacemaker implantation was required in one case (11.1%). Device success was achieved in 88.9% (n = 8), 30-day mortality was in 11.1% (n = 1), and intermediate mortality was in 33.3% (n = 3). TAo-TAVR approach offers definitive treatment to high-risk patients with coexisting complex cardiac lesions. Despite the relatively high 30-day and intermediate mortality, it is an option for selected high-risk patients.

Descripción paso a paso de la técnica transaórtica para el tratamiento transcatéter de la estenosis aórtica severa

Transcatheter treatment of severe aortic stenosis has progressively evolved from since the first implant in humans performed by Cribier in 2002. The use of retrograde transfemoral and transapical accesses have been well standardised. With the technical improvements introduced into the devices, the trans-aortic route has increasingly been used. This new approach may have many advantages for the treatment of inoperable or high-risk patients. Our group started to use this technique in 2013, and it has become the preferred procedure for us, instead of the transapical approach. In this article, a step by step description is presented of our trans-aortic technique and its main advantages and disadvantages.

Transaortic vs Transapical Approach for TAVI: A single centre experience

Purpose: We present our experience with the transaortic transcatheter aortic valve implantation (TAVI) and compare this to the transapical route.

Acute Kidney Injury After Transcatheter Aortic Valve Replacement.

Acute kidney injury (AKI) during transcatheter aortic valve replacement (TAVR) increases morbidity and mortality. In this study, we investigated the incidence and risk factors for AKI in patients undergoing TAVR. Two hundred ninety consecutive patients underwent TAVR. Valve Academic Research Consortium (VARC)-I criteria for AKI diagnosis at 72 hours, and VARC-II criteria at seven days were employed. Overall AKI incidence was 24.62% (65/264): 50 patients at 72 hours and 15 patients at seven days. Multivariate logistic regression determined transapical (TA) approach (OR: 4.46 [1.37-7.63]), preprocedural glomerular filtration rate less than 45 mL/min (OR: 3.47 [1.35-14.70]), and blood transfusion (OR: 3.34 [1.58-11.09]) as independent predictors for AKI at 72 hours; and prior coronary artery bypass grafting (OR: 3.02 [1.007-9.09]) and peripheral artery disease (PAD) (OR: 3.53 [1.06-11.62]) for AKI at seven days. In-hospital and 30-day mortality was higher in AKI patients. Non-AKI patients' survival was 93% at six months, 89% at 12 months, and 86% at 24 months, whereas survival in AKI at 72 hours was 66% at 6, 12, and 24 months (HR AKI vs. non-AKI: 3.9 [CI: 2.0-7.6]), and survival in AKI at seven days was 64% at 6, 12, and 24 months, HR: 3.13 (CI: 1.42-6.92). For the 12 dialysis patients survival was 82% at 6, 12, and 24 months. AKI after TAVR is associated with worse outcomes. Blood transfusion should be administered restrictively in TAVR. Patients with CKD, PAD, prior CABG, and TA approach require close surveillance as they are at risk for AKI through seven days after TAVR. doi: 10.1111/jocs.12768 (J Card Surg 2016;31:416-422).

Transcatheter Mitral Valve Implantation: 30-day Outcome of First-in-Man Experience With an Apically Tethered Device.

A small number of transcatheter mitral valve implants (TMVIs) have been reported using devices designed to treat secondary mitral regurgitation (MR). However, MR has many etiologies, and patients have a broad spectrum of annular size, geometry, and lesions. There are a number of technical challenges for TMVI including left ventricular outflow tract obstruction and paravalvular MR. Thirty days' outcome of first-in-man implants with a novel TMVI device is reported. The Tendyne TMVI system consists of a porcine pericardial valve in a tethered nitinol frame. An apical tether fixed to an epicardial pad stabilizes the device. The device is fully repositionable and retrievable even after complete deployment. Preoperative assessment was performed with 3-dimensional (3D) transesophageal echocardiogram and multislice computed tomography to define annular dimensions, geometry, and guide surgical access. Three patients were deemed not to be candidates for conventional surgery or for treatment with any Conformitè Européenne-marked device by Heart Team Evaluation. They were a 68-year-old woman with prior coronary artery bypass grafts and severe functional MR; a 75-year-old man with prior coronary bypass grafts, significant renal dysfunction, and severe degenerative MR; and a frail 86-year-old man with severe degenerative MR. Each had a TMVI via a transapical approach through a left minithoracotomy. Apical tether tension was adjusted to optimize device position. Implantation was guided by 2D and 3D transesophageal echocardiogram. The apical pad facilitated LV apical closure. There were no procedural complications. No patient had hemodynamically significant residual MR or left ventricular outflow tract obstruction, and there was no significant mitral gradient. All patients were discharged to their own home (the third on the fifth postoperative day), all with significant improvement in their symptoms. All were alive and well 30 days after implant. Two patients with existing conduction abnormalities had cardiac resynchronisation therapy after the procedure, and one patient had para valvular leak (PVL) with evidence of hemolysis at 30 days, which reduced in severity with conservative treatment. The first-in-man experience with the Tendyne TMVI system is promising. Valve stabilization by an apical tether is a novel way to address some of the challenges of TMVI. The unique Tendyne design features may offer potential for its use across a wide range of mitral valve pathologies.

Catheter-based treatment of paravalvular leaks

The incidence of paravalvular leaks after surgical valve replacement is estimated to be 2-17%. Paravalvular leaks (PVL) can be asymptomatic and not require treatment or can cause haemolysis or heart failure. If symptomatic or if the severity of the leak is moderate or severe, redo surgery is a therapeutic option, but this is accompanied by a high perioperative risk and a high recurrence rate. A lower risk alternative is percutaneous PVL closure, with a 1-2% risk of periprocedural death or need for reoperation. These procedures are often intricate, which is reflected by a rather modest rate of procedural success (reported to be around 80%). This requires that better technical solutions become available in the future. Today, only two dedicated devices for PVL closure exist, the AMPLATZER Vascular Plug III and the paravalvular leak device. Besides, many non-dedicated devices are used, such as atrial septal occluders, ventricular septal occluders and a variety of vascular plugs. While aortic PVL are approached with a retrograde transarterial approach, mitral PVL can be approached using either an antegrade transvenous approach (transseptal), a retrograde transapical approach or, rarely, a retrograde transaortic approach.

Acute Kidney Injury After Transfemoral Versus Transapical Approach for Transcatheter Aortic Valve Replacement

Acute Kidney Injury After Transfemoral Versus Transapical Approach for Transcatheter Aortic Valve Replacement

3D Printed Cardiac Phantom for Procedural Planning of a Transcatheter Native Mitral Valve Replacement.

After performing the mock-procedure on the cardiac phantom, the cardiologists optimized their transapical surgical approach. The mitral valve stenosis and calcification were clearly visible. The phantom was used to inform the sizing of the valve to be implanted. With advances in image processing and 3D printing technology, it is possible to create realistic patient-specific phantoms which can act as a guide for the interventional team. Using 3D printed phantoms as a valve sizing method shows potential as a more informative technique than typical CTA reconstruction alone.

Valve-in-Valve Transcatheter Valve Implantation in the Nonaortic Position.

Transcatheter valve-in-valve (VIV) procedures are an alternative to standard surgical valve replacement in high risk patients. Cases in which a commercially approved transcatheter aortic valve replacement (TAVR) device was used for a nonaortic VIV procedure between November 2013 and September 2015 are reviewed. Clinical, echocardiographic, and procedural details, patient survival, and symptom severity by NYHA class at follow-up were assessed. All patients were heart-team determined high risk for conventional redo surgery (mean STS PROM = 6.8 ± 2.2%). Five patients underwent VIV replacement in the nonaortic position, four for bioprosthetic mitral valve dysfunction, and one for bioprosthetic tricuspid valve dysfunction. Bioprosthetic failure was due to stenosis in three patients and regurgitation in two others. A balloon-expandable device was used for all patients (Edwards Lifesciences, Irvine, CA, USA). Transcatheter VIV replacement was accomplished by the transapical (mitral) and transfemoral venous (tricuspid) approaches. Median postoperative length of stay was five days (range 3-12). No deaths occurred at a mean follow-up of 21 months. NYHA class at follow-up decreased from class IV at baseline to class I or II for all patients. No paravalvular leaks greater than trivial were encountered. Median mean gradient following mitral replacement was 6.5 mmHg (range 6-13 mmHg), and following tricuspid replacement was 4 mmHg. Postoperative complications included hematuria, epistaxis, acute kidney injury, and atrial fibrillation. Transcatheter VIV implantation in the nonaortic position for dysfunctional bioprostheses can be performed safely with favorable clinical outcomes using a balloon expandable TAVR device. doi: 10.1111/jocs.12745 (J Card Surg 2016;31:282-288).

Atrial Fibrillation During or After TAVI: Incidence, Implications and Therapeutical Considerations.

Aortic stenosis is one of the most frequent valvulopathy of modern time necessitating interventional therapy when symptoms arise and stenosis becomes severe. First line treatment has traditionally been surgical aortic valve replacement (SAVR). However in the last decade transcatheter aortic valve implantation (TAVI) with bioprosthetic valves has proved to be a sound solution for high-risk for SAVR or inoperable patients. As expected implantation of the bioprosthetic device requires administration of antiplatelet regimen to the patients for a certain period. Atrial fibrillation (AF) may occur frequently during the peri-procedural period. In this background, the occurrence of AF after device implantation may be a challenging issue. We performed a literature search of PubMed and Embase database. Published articles reporting the incidence, clinical implications and description of antithrombotic regimen of New-onset atrial fibrillation (NOAF) in individuals undergoing TAVI were considered eligible. Incidence, Implications and Antithrombotic Regimen: The overall occurrence of NOAF is reported to be 1%-32% after TAVI. Left atrial enlargement and transapical approach constitute independent predictors for NOAF. Additionally it has been shown that patients with AF face an increased risk of death irrespective of the type of AF. Patients, with a history of AF, present greater rate of death than individuals with NOAF. NOAF is responsible for cerebrovascular events (CVE) occurring in the subacute phase (days 1-30) after the procedure. The risk of stroke/transient ischemic attack after TAVI is increased at least two fold by the presence of atrial fibrillation. Empirically, a dual antiplatelet strategy has been used for patients undergoing TAVR, including aspirin and a thienopyridine. In cases where patients are in need of oral anticoagulation after TAVI a combination of aspirin or thienopyridine with acenocoumarol has been the preferred regimen. Despite the continuously crescent use of TAVI for patients with symptomatic severe aortic stenosis, there are still many aspects of this procedure to be clarified. A lack of data exists from the available clinical trials regarding the appropriate anticoagulation therapy for patients with greater risk for thromboembolic events. As a result, patient's treatment remains at the discretion of the physician. Limited data are available regarding the optimal therapeutic regimen in patients undergoing TAVI who need therapy for AF. Carefully designed clinical studies might further clarify the incidence and interrelation between atrial fibrillation and TAVI. The balance between the efficacy and risk of anticoagulation needs to be further clarified in patients undergoing TAVI.

Advancing a Guiding Catheter Across a Mechanical Aortic Valve.

Postoperative mitral paravalvular leaks (MPVLs) occur in approximately 5% of patients undergoing mitral valve replacement and are associated with substantial morbidity. Although surgical repair is the gold standard, it carries a significant risk of morbidity and death, which makes percutaneous closure guided by transesophageal echocardiography a viable and attractive approach in high-risk patients.1 Most case reports discuss an antegrade or transapical approach via an arteriovenous wire loop that serves as a monorail, in order to advance and deploy a closure device. A few case reports1–3 have described a retrograde approach in patients with normal aortic valves, wherein the proximal disc of the device is deployed into the left atrium via an arterial wire. This approach saves operative time and fluoroscopy time, and lowers the risk of sequelae by avoiding a transseptal puncture and an arteriovenous loop.3 The retrograde approach is usually better in patients with medial defects or with defects that create a large gradient across the leak.4The concern is that advancing a guiding catheter across a mono- or bileaflet mechanical aortic valve can cause temporary valve malfunction and hemodynamic compromise. There have been a few published reports4,5 of cases wherein a small guiding catheter was advanced across a mechanical aortic valve to facilitate the making of an arteriovenous loop by advancing the wire through the left ventricle and across the defect into the left atrium. The wire is then snared into the venous system.Until this issue of the Texas Heart Institute Journal, there has, to our knowledge, been no mention in the literature of deploying a closure device through a mechanical aortic valve solely by the retrograde technique. The authors of the case series6 report 2 such instances, in which MPVLs were closed in a retrograde fashion. They first tested the hemodynamic effect of crossing the mechanical aortic valve by using a 6F catheter, and then proceeded with deployment. They gave themselves a 5-minute limit in each attempt and encountered no sequelae of great consequence. Despite their success, we worry that this approach of passing a catheter through a mechanical valve is dangerous. The authors appear to agree, because they limit each attempt to 5 minutes. The worst potential sequela is valve damage and leaflet immobility that result in “wide-open” aortic regurgitation and catastrophic hemodynamic consequences.In patients with MPVL and a mechanical aortic valve, we should still attempt an antegrade technique first, because it remains safer, with better support during deployment of the closure device. This case report shows the retrograde approach to be a feasible option only when the other approaches have failed in such patients, or are not viable. The retrograde approach should be the last resort in an otherwise-inoperable patient. Further studies are needed to validate the optimal timing and technique.

Cutaneo-Pericardial Fistula After Transapical Approach for Transcatheter Aortic Valve Replacement

A 77-year-old male with severe aortic stenosis, prior coronary artery bypass graft, recurrent infective endocarditis, and chronic Q fever (taking hydroxychloroquine and doxycycline) underwent a transcatheter aortic valve replacement (TAVR) by the transapical (TA) approach via left thoracotomy. A 29-

International experience with endovascular therapy of the ascending aorta with a dedicated endograft

The objective of this study was to evaluate the safety and feasibility of a novel stent graft specifically designed for treatment of the ascending aorta. This was a multicenter, retrospective analysis of all consecutive patients treated with the dedicated Zenith Ascend TAA Endovascular Graft (William Cook Europe, Bjaeverskov, Denmark) for pathologic processes requiring stent grafting of the ascending aorta. The graft is short (6.5cm), with a delivery system designed for transfemoral placement in the ascending aorta. In 10 patients (five men; age, 67years; range, 26-90years), the Zenith Ascend graft was implanted for the following indications: dissection (n= 5) and aneurysm (n= 4) of the ascending aorta and fixation of an intraprocedural dislocated aortic valve (n= 1). All patients were judged to be at high risk for open surgery (nine patients were classified as American Society of Anesthesiologists class 3 or class 4). A transfemoral approach was selected in eight cases and a transapical approach in two. All endografts were successfully deployed without intraoperative adverse events at the targeted landing zone. Clinical success in coverage of the lesions was achieved in all cases with the exception of an attempted treatment of an intraprocedural aortic valve implantation dissection that resulted in early mortality. The 30-day survival was 90%. Early neurologic events included one patient with stroke and paraplegia and one patient with a transient ischemic attack. One patient underwent early evacuation of a hemopericardium. There were two late reinterventions for persisting endoleaks. At a mean follow-up of 10months (range, 1-36months), three late deaths occurred, with one treatment related, as a result of graft infection. Despite the fact that in this first published series the graft was frequently used as a "rescue tool" outside its intended indication, treatment with the Zenith Ascend graft in this early experience appears to be safe and feasible for repair of ascending aorta pathologic processes in high-risk patients unsuitable for open repair.

Early and late outcomes after trans-catheter aortic valve implantation in patients with previous chest radiation

ObjectiveSurgery for aortic stenosis in patients with thoracic radiation therapy is associated with high morbi-mortality. Trans-catheter aortic valve implantation (TAVI) represents an alternative but has never been studied in this...

Apical access and closure devices for transapical transcatheter heart valve procedures.

The majority of transcatheter aortic valve implantations, structural heart procedures and the newly developed transcatheter mitral valve repair and replacement are traditionally performed either through a transfemoral or a transapical access site, depending on the presence of severe peripheral vascular disease or anatomic limitations. The transapical approach, which carries specific advantages related to its antegrade nature and the short distance between the introduction site and the cardiac target, is traditionally performed through a left anterolateral mini-thoracotomy and requires rib retractors, soft tissue retractors and reinforced apical sutures to secure, at first, the left ventricular apex for the introduction of the stent-valve delivery systems and then to seal the access site at the end of the procedure. However, despite the advent of low-profile apical sheaths and newly designed delivery systems, the apical approach represents a challenge for the surgeon, as it has the risk of apical tear, life-threatening apical bleeding, myocardial damage, coronary damage and infections. Last but not least, the use of large-calibre stent-valve delivery systems and devices through standard mini-thoracotomies compromises any attempt to perform transapical transcatheter structural heart procedures entirely percutaneously, as happens with the transfemoral access site, or via a thoracoscopic or a miniaturised video-assisted percutaneous technique. During the past few years, prototypes of apical access and closure devices for transapical heart valve procedures have been developed and tested to make this standardised successful procedure easier. Some of them represent an important step towards the development of truly percutaneous transcatheter transapical heart valve procedures in the clinical setting.

Conventional vs. Transapical vs. Transfemoral Aortic Valve Replacement - Real World Comparison of 3,751 Patients

Background and Hypothesis: Transcatheter aortic valve replacement (TAVR) is an established method in high-risk patients. Two aspects of this procedure are currently under discussion: 1.) Do the data acquired from randomized studies and registers justify expansion of the procedure to include younger and healthier patients? 2.) Is the transfemoral approach superior to the transapical approach with regard to mortality and periprocedural complications? Against this background we examined the mortality and morbidity of all patients who received an isolated conventional, transapical or transfemoral aortic valve replacement in accordance with the criteria of the Valve Academic Research Consortium (VARC)-2.