Update on Transcatheter Aortic Valve Implantation

Aortic stenosis affects a significant number of patients worldwide, and carries a dismal prognosis once symptoms develop. Unfortunately, a large number of patients present a prohibitive risk for surgical aortic valve replacement. Therefore, transcatheter aortic valve implantation has emerged as a promising technology for providing treatment to this group of patients. Currently available valves include the balloon-expandable Edwards SAPIEN valve (Edwards Lifesciences, Irvine, CA), which is usually implanted via a transfemoral or transapical approach, and the self-expanding CoreValve ReValving system (Medtronic, Minneapolis, MN), which uses only the transfemoral route. Early experience with the procedure performed on a compassionate-use basis was encouraging, and led to a number of first-in-man and feasibility studies. These trials demonstrated the safety and efficacy of valve implantation and led to CE (European Conformity) mark approval of both valves in Europe. Use of the SAPIEN valve in the United States is limited to the recently completed PARTNER (Placement of Aortic Transcatheter Valve) randomized trial comparing transcatheter and surgical aortic valve replacement in high-risk patients, and its post-trial registry. The CoreValve is not yet available in the United States. With improved device technology, better understanding of patient selection and pre- and periprocedural imaging, and greater procedural experience, widespread diffusion of transcatheter aortic valve implantation is expected.     

Transseptal Mitral Valve Replacement after Transcatheter Aortic Valve Implantation

We report a case of mitral valve replacement in a patient who had previously undergone transcatheter aortic valve implantation. A transseptal approach was used to avoid displacing the aortic prosthesis. Because of the small mitral annulus, a bioprosthetic aortic valve was used in reverse position for mitral valve replacement. The procedure did not interfere with the existing prosthesis, and a follow-up echocardiogram showed that both prosthetic valves were functioning well.To the best of our knowledge, this is the first report of mitral valve replacement in a patient who had a preceding transcatheter aortic valve implantation. We believe that the transseptal approach is promising for mitral valve replacement in such patients. Moreover, using a bioprosthetic aortic valve in reverse position is an option for mitral valve replacement when the mitral annulus is too small for placement of a standard bioprosthetic mitral valve.Key words: Aged, 80 and over; aortic valve; bioprosthesis; calcinosis/complications; cardiac surgical procedures; heart atria/surgery; heart valve prosthesis implantation; mitral valve insufficiency/surgeryTranscatheter aortic valve implantation (TAVI) is currently emerging as a valuable option to treat high-risk patients with severe, symptomatic aortic stenosis.¹ The number of patients receiving TAVI has increased dramatically over a short period of time because of the promising advances in this new technology and the growing number of high-risk, elderly patients with multiple comorbidities, who are better suited for a minimally invasive procedure. Consequently, cardiac surgeons must care for an increasing number of patients who have undergone TAVI. Subsequent cardiac procedures in the setting of previous TAVI pose a challenge due to the risks of procedural interference with—and postprocedural functional impairment of—the previous aortic prosthesis. The following case illustrates an effective method of performing a mitral valve replacement in the setting of previous TAVI.     

Transcatheter Aortic Valve Implantation

Severe aortic stenosis (AS) is a life-threatening condition when left untreated. Aortic valve replacement (AVR) is the gold standard treatment for the majority of patients; however, transcatheter aortic valve implantation/replacement (TAVI/TAVR) has emerged as the preferred treatment for high-risk or inoperable patients. The concept of transcatheter heart valves originated in the 1960s and has evolved into the current Edwards Sapien and Medtronic CoreValve platforms available for clinical use. Complications following TAVI, including cerebrovascular events, perivalvular regurgitation, vascular injury, and heart block have decreased with experience and evolving technology, such that ongoing trials studying TAVI in lower risk patients have become tenable. The multidisciplinary team involving the cardiac surgeon and cardiologist plays an essential role in patient selection, procedural conduct, and perioperative care.     

Transcatheter Aortic Valve Implantation through a Left Aortoiliac Graft

The indications for transcatheter aortic valve implantation have been increasing with the development of new-generation valves and delivery systems. Our patient, an 81-year-old man with aortic stenosis, had an existing coronary artery bypass graft and bilateral aortoiliac bypass grafts. We used the transfemoral approach through the left femoral artery and the left aortoiliac graft to successfully deploy a new-generation Edwards SAPIEN valve.Key words: Aortic stenosis, arterial disease, peripheral, heart valve prosthesis implantation/methods, transcatheter aortic valve implantationTranscatheter aortic valve implantation (TAVI) has emerged as a promising alternative to conventional aortic valve replacement for patients whose severe, symptomatic aortic stenosis is otherwise left untreated due to comorbidities and to the high operative mortality rates associated with open-heart surgery under those circumstances.¹ The first application of this method in human beings was performed in 2002 by Cribier and colleagues.² Today, there are 2 widely used valve types. These are the balloon-expandable Edwards SAPIEN transcatheter valves (Edwards Lifesciences LLC; Irvine, Calif) and the self-expanding CoreValve® valves (Medtronic CV Luxembourg S.a.r.l.; Luxembourg). The first-generation Edwards SAPIEN valve is approved for use in the United States, but the latest generations of both valves are awaiting approval.     

经导管二尖瓣植入术的进展

二尖瓣关闭不全是最为常见的瓣膜疾病之一。近年来，介入技术在经导管二尖瓣置换方面取得了巨大进展。国内外目前已有Tiara等5种介入二尖瓣系统成功应用于临床，并有少量病例报道，同时有近20家公司和医疗机构进行相关器材和设备的研发，初步的研究结果显示具有良好安全性和有效性。虽然仍有一些尚待解决的问题，相信随着研究的深入，经导管二尖瓣置换必将逐步走向成熟，在治疗二尖瓣关闭不全上取得新的突破，为更多的患者提供一种微创、有效、安全的治疗手段。本文针对经导管二尖瓣植入术的可行性、安全性等方面进行全面综述。     

Transcatheter Aortic Valve Implantation Despite Challenging Vascular Access

We describe transcatheter aortic valve implantation in a patient who had severe peripheral artery disease. The patient''s vascular condition required additional preliminary peripheral intervention to enable adequate vascular access.A 78-year-old man with severe aortic stenosis, substantial comorbidities, and severe heart failure symptoms was referred for aortic valve replacement. The patient''s 20-mm aortic annulus necessitated the use of a 23-mm Edwards Sapien valve inserted through a 22F sheath, which itself needed a vessel diameter of at least 7 mm for percutaneous delivery. The left common femoral artery was selected for valve delivery. The left iliac artery and infrarenal aorta underwent extensive intervention to achieve an intraluminal diameter larger than 7 mm. After aortic valvuloplasty, valve deployment was successful, and the transaortic gradient decreased from 40 mmHg to less than 5 mmHg. The patient was discharged from the hospital 4 days postoperatively. We conclude that transcatheter aortic valve implantation can be successfully performed in patients with obstructed vascular access, including stenosis of the infrarenal aorta and the subclavian and coronary arteries.     

First Direct Aortic Retrievable Transcatheter Aortic Valve Implantation in Humans

We describe 2 cases in which transcatheter aortic valve implantation was performed with a Portico prosthesis (St Jude Medical, St Paul, MN) through a direct aortic approach. In 1 of the cases, prosthesis retrieval was needed during the procedure and was essential to the successful outcome. This is the first report, to our knowledge, of direct aortic Portico prosthesis implantation, and it highlights the significance of the retrievable nature of this device.     

Left Bundle Branch Block after Transcatheter Aortic Valve Implantation with Edwards Sapien 3 Valve: Influence of the Valve Depth Implantation

ObjectivesThe aim of this study is to determine the relation between the valve depth implantation and the new-onset left bundle branch block (LBBB) in patients treated with transcatheter aortic valve implantation (TAVI) using Edwards Sapien 3 (S3) prosthesis.BackgroundLBBB is the most common conduction disturbance after TAVI. The S3 has been associated with a higher incidence of LBBB. A deep valve implant could be related to new-onset LBBB with S3.MethodsSeventy-six consecutive patients treated with transfemoral TAVI with S3 were included. Electrocardiogram (ECG) registries were recorded at baseline, after the procedure, and before discharge. Valve depth implantation was determined in 40 patients by off-line analysis of the two/three-dimensional transeophageal echocardiogram (TEE) images, with measure of the valve stent percentage under the aortic annulus. Previous and new conduction anomalies were documented; and patient, anatomic and procedural characteristics were retrospectively analyzed.ResultsComplete atrioventricular block (AVB) incidence was 2.9%. LBBB after TAVI appeared in 39% of patients, being transient in almost half of the cases (permanent LBBB rate 20%).Patients with new-onset LBBB after TAVI were older, with a higher STS Score and a wider basal QRS.A deep valve position was associated with new-onset LBBB, with a ROC curve establishing a cut-off point of 34% of depth implant as risk factor for new-onset LBBB (sensitivity and specificity 0.8).ConclusionsIn transfemoral TAVI with S3 prosthesis, a higher valve implantation (<34% of valve stent introduced into the ventricle) may minimize the new-onset LBBB, especially in old and high-risk patients with a wide basal QRS.     

Transcatheter Aortic Valve Implantation in a Patient With Severe Aortic Insufficiency and Minimal Aortic Annular Calcification

Severe aortic insufficiency with minimal aortic annular calcification has been considered a relative contraindication to transcatheter aortic valve implantation (TAVI) because of a lack of calcium for fluoroscopic visualization and radial stent fixation. We report a patient with severe aortic insufficiency after previous coronary artery bypass and aortic valve repair who underwent successful TAVI. Intraoperative transesophageal echocardiography was critical to guide valve implantation and previous surgical pledgets were used to seat an oversized TAVI prosthesis within the aortic annulus. In follow-up, the patient remained New York Heart Association class I and echocardiography demonstrated a well-functioning TAVI prosthesis with no aortic insufficiency.     

Transfemoral Edwards SAPIEN Aortic Valve Implantation Through Aortofemoral Endograft

We present the case of an 86-year-old woman with an aortobifemoral endograft and porcelain aorta who underwent transfemoral transcatheter aortic valve implantation (TAVI). A femoral cutdown was performed to the left limb of the endograft, and the needle puncture into the graft required sequential incisions and dilation to allow access of the 18F Edwards SAPIEN expandable eSheath (Edwards Lifesciences, Irvine, CA). A 26-mm Edwards SAPIEN transcatheter aortic valve was then successfully deployed. The cutdown was closed and hemostasis was achieved without any iatrogenic narrowing of the graft. Transfemoral TAVI through surgical cutdown with dilation of a femoral endograft is safe and feasible.     

经导管主动脉瓣中瓣植入术的并发症及其处理进展

经导管主动脉瓣中瓣植入术是生物瓣毁损后最理想的二次和多次干预手段之一,尤其适合于高危或不耐受手术患者。随着此类术式在国内外临床应用和报道的不断增加,新技术同样带来了新问题,如冠状动脉阻塞和术后跨瓣压差增高等,因此对其发生机制及处理最新进展加以综述就变得十分必要。     

Initial German Experience With Transapical Implantation of a Second-Generation Transcatheter Heart Valve for the Treatment of Aortic Regurgitation

ObjectivesThis analysis reports on the initial German multicenter experience with the JenaValve (JenaValve Technology GmbH, Munich, Germany) transcatheter heart valve for the treatment of pure aortic regurgitation.BackgroundExperience with transcatheter aortic valve implantation (TAVI) for severe aortic regurgitation is limited due to the risk of insufficient anchoring of the valve stent within the noncalcified aortic annulus.MethodsTransapical TAVI with a JenaValve for the treatment of severe aortic regurgitation was performed in 31 patients (age 73.8 ± 9.1 years) in 9 German centers. All patients were considered high risk for surgery (logistic EuroSCORE [European System for Cardiac Operative Risk Evaluation] 23.6 ± 14.5%) according to a local heart team consensus. Procedural results and clinical outcomes up to 6 months were analyzed.ResultsImplantation was successful in 30 of 31 cases (aortic annulus diameter 24.7 ± 1.5 mm); transcatheter heart valve dislodgement necessitated valve-in-valve implantation in 1 patient. Post-procedural aortic regurgitation was none/trace in 28 of 31 and mild in 3 of 31 patients. During follow-up, 2 patients underwent valvular reinterventions (surgical aortic valve replacement for endocarditis, valve-in-valve implantation for increasing paravalvular regurgitation). All-cause mortality was 12.9% and 19.3% at 30 days and 6 months, respectively. In the remaining patients, a significant improvement in New York Heart Association class was observed and persisted up to 6 months after TAVI.ConclusionsAortic regurgitation remains a challenging pathology for TAVI. After initial demonstration of feasibility, this multicenter study revealed the JenaValve transcatheter heart valve as a reasonable option in this subset of patients. However, a significant early noncardiac mortality related to the high-risk population emphasizes the need for careful patient selection.     

Sheathless Transcaval Transcatheter Aortic Valve Implantation Through an Abdominal Aortic Graft

An 82-year-old patient presented with severe symptomatic aortic stenosis, a high surgical risk profile, and a history of abdominal aortic replacement. Arterial access vessel conditions precluded transarterial transcatheter aortic valve implantation (TAVI). Transcaval access through the aortic graft was achieved; however, tortuosity and resistance at the graft entry site hampered insertion of the introducer sheath and delivery system. Transcaval TAVI without a sheath was contemplated with the expectation of aortocaval fistulous decompression of blood around the TAVI catheter. Hemodynamic measures remained stable, and the valve was successfully implanted. This case illustrates the feasibility of sheathless transcaval TAVI without relevant hemodynamic compromise.     

Valve-in-Valve-in-Valve Transcatheter Aortic Valve Implantation to Treat a Degenerated Surgical Bioprosthesis in a Subaortic Position

Transcatheter aortic valve implantation for aortic stenosis has evolved as an alternative treatment for patients who are at high or excessive surgical risk. We report the case of an 84-year-old man with a degenerated surgically implanted valve in a subaortic position (9 mm below the native annulus) who underwent “valve-in-valve” transcatheter aortic valve implantation with use of a Medtronic CoreValve system. We planned to deploy the CoreValve at a conventional depth in the left ventricular outflow tract; we realized that this might result in paravalvular regurgitation, but it would also afford a “deep” landing site for a second valve, if necessary. Ultimately, we implanted a second CoreValve deep in the left ventricular outflow tract to seal a paravalvular leak. The frame of the first valve—positioned at the conventional depth—enabled secure anchoring of the second valve in a deeper position, which in turn effected successful treatment of the failing subaortic surgical prosthesis without paravalvular regurgitation.Key words: Aortic valve insufficiency/surgery, bioprosthesis, heart valve prosthesis implantation/instrumentation/methods, intention-to-treat analysis, reoperation/methods, risk assessment, treatment outcomeTranscatheter aortic valve implantation (TAVI) has emerged as an alternative to surgical aortic valve replacement for the treatment of aortic stenosis in patients who are at high or excessive operative risk.¹ It has been shown that implanting a transcatheter valve within a failing surgical valve (“valve-in-valve”) is safe and effective.² However, the feasibility of this intervention for failing valves in subaortic position has not been reported. The implantation of a self-expandable transcatheter valve at a deep level in the left ventricular outflow tract (LVOT) (with inflow portion >8 mm below the noncoronary cusp) could expectedly be associated with an increased risk of paravalvular regurgitation, valve dislodgment, or both, because of insecure anchoring of the prosthesis in the lower anatomic structures of the LVOT.³ We report the case of a patient in whom we implanted 2 CoreValve® devices (Medtronic, Inc.; Minneapolis, Minn), to safely replace a failing surgical bioprosthesis in a subaortic position.     

Role of Echocardiography Before Transcatheter Aortic Valve Implantation (TAVI)

Aortic stenosis (AS) is the most common primary valve disorder in the elderly with an increasing prevalence; transcatheter aortic valve implantation (TAVI) has become an accepted alternative to surgical aortic valve replacement (AVR) in the high risk or inoperable patient. Appropriate selection of patients for TAVI is crucial and requires a multidisciplinary approach including cardiothoracic surgeons, interventional cardiologists, anaesthetists, imaging experts and specialist nurses. Multimodality imaging including echocardiography, CT and MRI plays a pivotal role in the selection and planning process; however, echocardiography remains the primary imaging modality used for patient selection, intra-procedural guidance, post-procedural assessment and long-term follow-up. The contribution that contemporary transthoracic and transoesophageal echocardiography make to the selection and planning of TAVI is described in this article.     

经导管主动脉瓣置入术临床应用

经导管主动脉瓣膜置入术是近年来出现一种治疗主动脉瓣狭窄的新兴技术,可以通过微创的方法治疗心脏瓣膜病。主动脉瓣狭窄传统治疗需要外科手术换瓣治疗,尤其合并左心功能不全的老年患者风险很大,且有些患者存在手术禁忌证。经导管置换主动脉瓣会给患者带来巨大的利益,其主要优点是体现在微创、避免体外循环及输血、缩短住院时间等方面。     

Transcatheter Aortic Valve-in-Valve Implantation for Patients With Degenerative Surgical Bioprosthetic Valves

Most surgical heart valves currently implanted are bioprosthetic tissue valves. Such valves deteriorate with time, eventually presenting with either stenosis or regurgitation. Reoperation, the current standard of care for failed valves, carries significant risk in terms of both morbidity and mortality. Implantation of a transcatheter valve inside a failed surgical valve (valve-in-valve procedure) has recently emerged as an alternative, less-invasive option. Although the procedure is similar in some aspects to transcatheter aortic valve implantation in the setting of native aortic valve stenosis, there are many differences that deserve special consideration. We review the potential and challenges of valve-in-valve implantation in patients with failing surgical aortic bioprostheses.     

Successful Transcatheter Aortic Valve Implantation in a Patient with Radiation-induced Aortic Stenosis for Mediastinal Hodgkin Lymphoma

Aortic stenosis (AS), a late complication of thoracic radiation therapy for chest lesions, is often coincident with porcelain aorta or hostile thorax. We herein report a 59-year-old man with a history of mediastinal Hodgkin lymphoma treated with radiation therapy but later presenting with heart failure caused by severe AS. Severe calcification in the mediastinum and around the ascending aorta made it difficult to perform surgical aortic valve replacement. The patient therefore underwent transcatheter aortic valve implantation (TAVI). It is important to recognize radiation-induced AS early, now that TAVI is a well-established treatment required by increasing numbers of successfully treated cancer patients.     

Perceval Sutureless Valve – are Sutureless Valves Here?

With the advent of transcatheter aortic valve implantation (TAVI) techniques, a renewed interest has developed in sutureless aortic valve concepts in the last decade. The main feature of sutureless aortic valve implantation is the speed of insertion, thus making implantation easier for the surgeon. As a result, cross clamp times and myocardial ischemia may be reduced. The combined procedures (CABG with AVR in particular) can be done with a short cross clamp time. Perceval valve also provides an increased effective orifice area as compared with a stented bioprosthesis. Sutureless implantation of the Perceval valve is not only associated with shorter cross-clamp and cardiopulmonary bypass times but improved clinical outcomes too. This review covers the sutureless aortic valves and their evolution, with elaborate details on Perceval S valve in particular (which is the most widely used sutureless valve around the globe).     

Optimized Implantation Height of the Edwards SAPIEN 3 Valve to Minimize Pacemaker Implantation After TAVI

Aim

The transcatheter aortic valve SAPIEN 3 aims at reducing paravalvular leakage (PVL). The new design with outer sealing cuff may increase the risk of permanent pacemaker implantation (PPM). The aim of our study was to evaluate the optimal implantation height of the SAPIEN 3.

Methods and Results

We analysed the correlation between the implantation height of the valve and the need for PPM in 131 patients. The PPM rate for the entire group after TAVI was 18% (n = 24). In patients with a marker distance <2 mm (“low implantation”), the PPM rate was 32%, whereas in patients with a distance ≥2 mm (“high implantation”), the rate was only 4.7% (OR of 0.1 (0.03–0.37, P < 0.001)).

Conclusion

The risk of periprocedural PPM with the Edwards SAPIEN 3 depends on implantation height; it is increased when using conventional implantation techniques. This risk can be minimized below 5% PPM by choosing a higher implantation technique with the central marker 2 mm or more over the annulus plane.