Rare complication of ventricular septal defect in three patients following transcatheter aortic valve replacement

Transcatheter aortic valve replacement (TAVR) is a highly‐effective but technically challenging procedure. Despite improvement in device technology and operator techniques, complications are common and previously unknown procedural‐related complications continue to arise. In this report, we present a case series of three patients with acquired perimembranous ventricular septal defects following transfemoral TAVR with an Edwards SAPIEN prosthesis. © 2013 Wiley Periodicals, Inc.     

Urgent transcatheter aortic valve replacement for severe acute aortic regurgitation following open mitral valve surgery

Transcatheter aortic valve replacement (TAVR) is not currently approved for pure native valve aortic incompetence, and is typically performed on a compassionate basis in selected patients who are at high risk for conventional surgery. We describe the first use of TAVR to treat iatrogenic severe acute pure aortic incompetence following mitral valve surgery. A 71‐year‐old gentleman developed life‐threatening acute aortic regurgitation (AR) within hours of a very challenging fifth open heart mitral valve replacement. Careful inspection of echocardiographic and computed tomographic imaging identified the cause as a disrupted left coronary cusp at the commissure caused by the surgical mitral annular reconstruction. Medical management with afterload reduction failed with recurrent pulmonary edema, and a sixth open heart surgery was deemed prohibitively high risk. The lack of aortic annular calcium onto which anchors a transcatheter valve was a concern for TAVR. However, we postulated that the struts of the mitral valve bioprosthesis would offer some support to the TAVR valve. We opted for a self‐expanding system because of concerns about potential unfavorable interaction between the balloon onto which balloon‐expandable bioprosthesis is mounted and the struts of the mitral bioprosthesis, and because the Evolut R system has additional anchoring points at the crown which might enhance transcatheter valve stability in the non‐calcified annulus, compared with the Edwards Sapien system. Transfemoral TAVR, performed with a Medtronic Evolut R 34 mm system under general anesthesia and using moderately rapid ventricular pacing, was successful with minimal residual AR. On follow‐up 1 month later the patient was asymptomatic, and the aortic and mitral bioprostheses were functioning normally on echocardiogram.     

Left ventricular outflow tract embolization and balloon assisted recapture of a SAPIEN XT prosthesis during transcatheter aortic valve replacement

Transcatheter aortic valve replacement has emerged within the last decade as a proven alternative therapy in patients with severe aortic stenosis and prohibitive surgical risk. Despite rapidly evolving device technology and growing operator experience, peri‐procedural complications are still relatively common. We present a case in which a SAPIEN XT prosthetic valve embolized into the left ventricular outflow tract. This was followed by balloon assisted recapture and subsequent successful implantation of the valve across the aortic annulus without significant hemodynamic compromise or surgical intervention. © 2015 Wiley Periodicals, Inc.     

Echocardiography in transcatheter aortic valve implantation—Part 1—Transthoracic echocardiography

Transcatheter aortic valve replacement (TAVR) has been a revolutionary technique in the treatment of degenerative aortic valve stenosis. Selection of appropriate patients and appropriate valve size is crucial for improved patient outcome. Echocardiographic imaging is a critical component for patient selection and plays an important role in the selection of valve size, procedural guidance, and patient follow‐up. This review discusses role of echocardiography in patient selection, device implantation, and postimplant follow‐up for the first‐generation CoreValve as used in pivotal trial. Same TTE imaging principles apply to the second‐ and third‐generation self‐expandable valves as well as the balloon‐expandable valves. Multiple case examples are used to illustrate imaging principles pre‐ and post‐TAVR. In addition, case examples to demonstrate complications post‐TAVR are shown.     

Procedural and clinical outcomes of the valve‐in‐valve technique for severe aortic insufficiency after balloon‐expandable transcatheter aortic valve replacement

Objective : To describe the clinical and procedural outcomes of patients treated with the valve‐in‐valve technique for severe aortic insufficiency (AI) after balloon‐expandable transcatheter aortic valve replacement (TAVR). Background : Severe AI immediately after valve implantation is a notable complication of TAVR. It can be treated with a valve‐in‐valve technique which involves deploying a second valve within the first one to crush the leaflets of the first implant leaving a new functional valve. Methods : We analyzed data on 142 consecutive patients at our institution undergoing TAVR with the Sapien valve between November of 2007 and April of 2011. Etiologies of acute AI, procedural and intermediate term clinical outcomes were reported for those in whom a valve‐in‐valve procedure was necessary. Post‐hoc analysis of these cases with C‐THV imaging (Paieon Medical Ltd.) was performed to elucidate the mechanism for successful AI treatment. Results : A total of 5 of 142 (3.5%) patients were treated with the valve‐in‐valve technique. Etiologies of the aortic valve insufficiency included bioprosthesis malposition (n = 3), valve dysfunction (n = 1), and valve undersizing (n = 1). With placement of the second valve, the first valve dimensions increased to approach the nominal valve size while the second valve size remained less than nominal. Conclusions : The valve‐in‐valve technique is an appropriate bailout measure for patients with acute valvular AI after balloon‐expandable TAVR. © 2012 Wiley Periodicals Inc.     

A very rare vascular complication of the Edwards expandable eSheath during transcatheter aortic valve replacement

Transcatheter aortic valve replacement (TAVR) has revolutionized the management of severe symptomatic aortic valve stenosis. TAVR is now indicated as an alternative to surgical replacement in a wide risk profile ranging from high to low surgical risk. Although vascular complications have decreased in frequency over time, with the introduction of lower profile delivery systems and sheaths, they remain one of the most frequently encountered and serious complications of TAVR. Patient-specific predisposing factors have been well characterized. However, much less is known about device-specific complications. Awareness of the possible device-related complications may lead to earlier identification, prompt management, and better outcomes. We report a previously unreported complication of the Edwards expandable eSheath that lead to avulsion of the external iliac artery following successful TAVR with a 29-mm Edwards Sapien 3 transcatheter heart valve. Bleeding was promptly controlled with an occlusion balloon and emergency surgical repair was required with a favorable outcome.     

Valve prosthesis distortion after cardiac compression in a patient who underwent transcatheter aortic valve implantation (TAVI)

Transcatheter aortic valve implantation (TAVI) has been developed as an alternative to conventional aortic valve replacement for the treatment of symptomatic severe aortic stenosis in high‐risk patients. Nevertheless, TAVI has been associated with serious complications such as stroke, vascular injury, renal failure, and arrhythmia. Herein we describe a case of distortion of the Edward‐Sapien prosthesis (Edwards Lifesciences, USA), which was mounted on a balloon‐expandable stent, after chest compression for cardiac resuscitation in a patient who underwent TAVI for severe aortic stenosis. © 2012 Wiley Periodicals, Inc.     

Emergent use of retrograde left ventricular support in patients after transcatheter aortic valve replacement

Transcatheter aortic valve replacement (TAVR) is currently a therapeutic alternative to open aortic valve replacement for high‐risk patients with severe symptomatic aortic valve stenosis. The procedure is associated with some life‐threatening complications including circulatory collapse which may require temporary hemodynamic support. We describe our experience with the use of the Impella 2.5 system to provide emergent left ventricular support in cases of hemodynamic collapse after TAVR with the Edwards SAPIEN prosthesis.© 2012 Wiley Periodicals, Inc.     

Transcatheter aortic valve implantation: Current status and future perspectives

Although surgical aortic valve replacement is the standard therapy for severe aortic stenosis(AS),about one third of patients are considered inoperable due to unacceptable surgical risk.Under medical treatment alone these patients have a very poor prognosis with a mortality rate of 50%at 2 years.Transcatheter aortic valve implantation(TAVI)has been used in these patients,and has shown robust results in the only randomized clinical trial of severe AS treatment performed so far.In this review,we will focus on the two commercially available systems:Edwards SAPIEN valve and CoreValve Revalving system.Both systems have demonstrated success rates of over 90%with 30-d mortality rates below 10%in the most recent transfemoral TAVI studies.Moreover,long-term studies have shown that the valves have good haemodynamic performance.Some studies are currently exploring the non-inferiority of TAVI procedures vs conventional surgery in high-risk patients,and long-term clinical results of the percutaneous valves.In this article we review the current status of TAVI including selection of patients,a comparison of available prostheses,results and complications of the procedure,clinical outcomes,and future perspectives.     

Transcatheter aortic valve in valve implantation with bioprosthetic valve fracture

Valve‐in‐valve transcatheter aortic valve replacement (VIV TAVR) has emerged as a preferable option for high surgical risk patients requiring redo aortic valve replacement. However, VIV TAVR may restrict flow, especially in small native aortic valves. To remedy this, bioprosthetic valve fracture has been utilized to increase the effective orifice area and improve hemodynamics. We present three cases in which bioprosthetic valve fracture was used to increase hemodynamic flow in VIV TAVR procedures.     

Reversible thrombotic aortic valve restenosis after valve‐in‐valve transcatheter aortic valve replacement

Thrombotic aortic valve restenosis following transcatheter aortic valve replacement (TAVR) has not been extensively reported and the rates of TAVR valve thrombosis are not known. We present three cases of valve‐in‐valve (VIV) restenosis following TAVR with the balloon expandable transcatheter heart valves, presumably due to valve thrombosis that improved with anticoagulation. © 2016 Wiley Periodicals, Inc.     

Self-Expanding Prostheses for Transcatheter Aortic Valve Replacement

Transcatheter aortic valve replacement (TAVR) has emerged as an alternative to surgical aortic valve replacement in patients who are considered high surgical risk or inoperable due to advanced age and comorbidities. Randomized trial and registry data have demonstrated the safety and efficacy of TAVR in such patients. Currently available transcatheter heart valves (THVs) employ either balloon-expandable or self-expanding designs, and several new designs have shown promising early results. Differences in valve design may offer specific advantages for accurate deployment and minimizing complications. This article reviews several designs of self-expanding THVs that are currently available or have undergone successful implantation in humans. Additional studies are required to compare the relative performance of these devices.     

Transseptal approach for the management of paravalvular regurgitation after transcatheter aortic valve replacement

In the era of transcatheter aortic valve therapies, the presence of residual paravalvular regurgitation (PVR) after transcatheter aortic valve replacement (TAVR) may become a clinical challenge. Management of late symptomatic PVR is still unknown. We describe a challenging case of percutaneous closure attempt of a clinically significant PVR in a patient after Edwards SAPIEN (Edwards Lifesciences, CA) TAVR. © 2012 Wiley Periodicals, Inc.     

Severe intraprosthetic regurgitation and valve embolization after transcatheter aortic valve implantation

Transcatheter aortic valve implantation is a novel therapeutic approach for high‐risk patients with severe symptomatic aortic stenosis. The success rate of this new procedure is high; however, procedural complications can occur and may result in devastating outcomes. Here, we report a case of transfemoral catheter aortic valve implantation using the Edwards SAPIEN valve complicated by severe intravalvular leak due to immobile cusp associated with shock. We treated with a second valve that embolized and deployed in the descending aorta. A third valve was then deployed within the first with elimination of aortic regurgitation and immediate hemodynamic improvement. © 2012 Wiley Periodicals, Inc.     

A novel approach to extraction of a large thrombus on the intraventricular guide‐wire during transcatheter aortic valve replacement

For appropriate patients with severe symptomatic aortic stenosis with a prohibitively high surgical risk, trans‐catheter aortic valve replacement (TAVR) is now established as a viable option. Thrombosis on the intra‐ventricular guide‐wire during TAVR is a recognized complication (Wiper et al., Cardiovasc Revasc Med 2014). There is an obvious potential for embolization with particular concern for stroke in this situation. We describe a case in which a >1cm thrombus was noted on the intra‐ventricular guide‐wire by trans‐esophageal echocardiogram (TEE) during a TAVR procedure. Balloon aortic valvuloplasty was still performed and an Edwards Sapien valve was deployed. After valve deployment a multi‐purpose guiding catheter was advanced with continuous suction. The guide‐wire and thrombus were withdrawn inside the guiding catheter. The guide‐wire and catheter were removed as a single unit, allowing the thrombus to be safely retrieved. We believe that this is a novel technique of aspiration thrombectomy in this potentially hazardous clinical circumstance. As our experience with TAVR increases, so does our experience with the complications. In the PARTNER trial there was a higher rate of neurological events in TAVR patients than those who had open aortic valve replacement (Smith et al. N Engl J Med 2011;364:2187–2198.). This may be related to peri‐procedural formation of thrombus and subsequent embolization. We report a case where a large guide‐wire thrombus identified during TAVR was successfully removed using a novel approach, preventing a potentially major stroke in this high‐risk patient. © 2015 Wiley Periodicals, Inc.     

Transcatheter aortic valve replacement in patients with pure native aortic valve regurgitation: A systematic review and meta‐analysis

This systematic review and meta‐analysis sought to summarize the available evidence on the use of transcatheter aortic valve replacement (TAVR) in patients with Native Aortic Valve Regurgitation (NAVR) and compare outcomes between first and second generation valves. Owing to the improvements in transcatheter heart valve design and procedural success, TAVR has become increasingly performed in broader aortic valve pathologies. We searched Medline, Embase, Cochrane, and Scopus databases from 2007 to 2018 and performed a systematic review on reports with at least 10 patients with aortic valve regurgitation undergoing TAVR procedure. The main outcome of interest was all‐cause mortality at 30 days. A total of 638 patients across 12 studies were included. Mean age ranged from 68 to 84. Society of Thoracic Surgeons score ranged from 5.4% to 13.1% and Logistic EuroSCORE ranged from 18.2% to 33%. The incidence rate of all‐cause mortality at 30 days was found to be 11% (95% CI 7%‐16%; I² = 20.86%). All‐cause mortality at 30 days for first generation valves had an incidence rate of 15% (95% CI 10%‐20%; I² = 10%) compared to 7% (95% CI 3%‐13%; I² = 37%) in second generation valves with subgroup interaction analysis P = 0.059. Device success incidence rate in second generation valves was 92% (95% CI 83%‐99%; I² = 67%) vs 68% (95% CI 59%‐77%; I² = 53%) in first generation valves with P = 0.001. TAVR appears to be a feasible treatment choice for NAVR patients at high risk for surgical valve replacement. Second generation valves show promising results in terms of short‐term outcomes.     

Intraprocedural balloon dilation of the direct flow medical transcatheter aortic valve: First United States experience

Optimization of hemodynamics during transcatheter aortic valve replacement (TAVR) using the commercially available balloon expandable and self‐expanding valves is often accomplished through post‐dilation of the valves' metallic frame. The direct flow medical (DFM) valve is a uniquely designed second‐generation TAVR prosthetic without a rigid metallic frame. It is not widely known whether balloon dilation of this valve is beneficial when valve hemodynamics after initial deployment suboptimal due to valve underexpansion. We present the first two US patients who underwent TAVR using the DFM valve who had underexpansion in the setting of bulky leaflet calcification that resulted in elevated valve gradients and were treated successfully using intraprocedural balloon dilation. © 2016 Wiley Periodicals, Inc.     

Salvaging lowermost deployment of an acurate device during transcatheter aortic valve replacement with balloon and lasso pull techniques

Transcatheter aortic valve replacement (TAVR), also known as transcatheter aortic valve implantation (TAVI), is being used with increasing frequency in patients with severe aortic stenosis at high or prohibitive surgical risk. A number of devices are becoming available for TAVR, and competence in using them is mandatory to maximize the safety and efficacy of TAVR, while individualizing device selection in keeping with patient features. The ACURATE TF is a novel promising device for transfemoral TAVR. However, its peculiar features may require additional maneuvers in case of complications. We hereby report the case of a patient undergoing transfemoral TAVR with the ACURATE TF device, in whom lowermost deployment was complicated by massive aortic regurgitation. With two separate remedial actions, the balloon pull and lasso techniques, we were able to pull back the device and significantly reduce post‐TAVR aortic regurgitation. Awareness of this complication and the possible use of these two techniques may increase the safety and efficacy of TAVR with this and other new devices. © 2015 Wiley Periodicals, Inc.     

经导管主动脉瓣置换的介入瓣膜的现状及展望

经导管主动脉瓣置换术（TAVR）经过最近几年快速发展已经取得巨大进步。迄今为止全球接受TAVR的患者数已近3万例,已成为无法耐受传统手术患者的标准备选治疗措施。从目前已临床应用的介入瓣膜到正在实验研究的新型介入瓣膜可以看出,未来介入瓣膜的发展目标是尺寸更小、长期有效、安全性高、并发症少、操作简单及定位精准。随着TAVR的推广,新型介入瓣的研发,操作者经验的积累,以及长期随访的开展,将给TAVR提供更科学的病例选择标准,减少介入手术的相关并发症,提高更安全有效的治疗效果。未来此项技术还会逐渐扩大适用人群的范围,成为代替传统的主动脉瓣置换术举足轻重的治疗措施。     

Long-term outcomes of balloon-expandable transcatheter aortic valve replacement in Japanese patients

BackgroundData on long-term outcomes of transcatheter aortic valve replacement (TAVR) in Japanese patients beyond 5 years are limited.MethodsBetween June 2010 and December 2014, 55 consecutive inoperable or high surgical risk patients underwent TAVR with SAPIEN XT valves (Edwards Lifesciences, Irvine, CA, USA) for severe aortic stenosis at our institution. Among them, 2 patients were excluded from the analysis because one was converted to open surgery during the TAVR procedure and the other could not undergo TAVR due to device delivery failure. We retrospectively analyzed long-term clinical outcomes of these 53 patients (mean age: 84.1 years; mean STS score: 8.4) who had at least a 7-year follow-up after TAVR.ResultsThe rates of freedom from all-cause and cardiovascular deaths at 7 years were 35.8 % and 79.3 %, respectively. The moderate or severe structural valve deterioration (SVD) rate at 5 and 7 years was 7.2 % and 11.4 %, respectively. The rate of bioprosthetic valve failure (BVF) at 7 years was 6.2 %.ConclusionsThe 7-year mortality rate of inoperable or high surgical risk patients treated with SAPIEN XT was high, while the cardiovascular mortality rate was acceptable. Although the poor survival rate limited the long-term assessment of SAPIEN XT valve durability, the incidence of SVD and BVF was not rare.