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.     

Simultaneous transapical transcatheter aortic valve replacement and transcatheter mitral valve replacement for native valvular stenosis

Transcatheter aortic valve replacement (TAVR) is well established for patients who cannot undergo surgery (Leon et al., N Engl J Med 2010;363:1597) or are high risk for surgery (Smith et al., N Engl J Med 2011;364:2187–2198). Experience with the TAVR procedure has led to recent reports of successful transcatheter mitral valve replacement (TMVR) procedures (Cheung et al., J Am Coll Cardiol 2014;64:1814; Seiffert et al., J Am Coll Cardiol Interv 2012;5:341–349) separately or simultaneously with the TAVR. However, these reports were of simultaneous valve‐in‐valve procedures (Cheung Anson, et al. J Am Coll Cardiol 2013;61:1759–1766). A recent report from Portugal also reported simultaneous transpical implantation of an inverted transcatheter aortic valve‐in‐ring in the mitral position and transcatheter aortic valve (Hasan et al., Circulation 2013;128:e74–e76). There has been an experience of TMVR only in native mitral valve for mitral valve stenosis, but none in both aortic and mitral valves. We report the first in human case of simultaneous transapical TAVR and TMVR in native valves secondary to valvular stenosis. Our patient was not a candidate for percutaneous balloon mitral valvuloplasty secondary to a high Wilkins Score. Sizing of the aortic valve was based on the transesophageal echocardiogram (TEE), whereas sizing of the mitral valve was based on TEE measurements and balloon inflation during left ventriculography. © 2015 Wiley Periodicals, Inc.     

Abnormal distortion of aortic corevalve bioprosthesis with suicide left ventricle,aortic insufficiency,and severe mitral regurgitation during transcatheter aortic valve replacement

We present a patient with critical degenerative aortic stenosis, mitral annular and aortomitral continuity calcification, and senile sigmoid septal hypertrophy who underwent transcatheter aortic valve replacement using the CoreValve bioprosthesis. Immediately after predilation of the aortic valve (18‐mm balloon), the patient developed severe hypotension and dynamic left ventricular outflow tract (LVOT) obstruction with systolic anterior motion of the anterior mitral leaflet, causing severe mitral regurgitation. After deployment of a 26‐mm bioprosthesis, a transesophageal echocardiogram and left ventriculogram showed that the frame of the bioprosthesis appeared distorted and underexpanded. On the mitral side of the aorta (side of the aortomitral curtain between 12:00 and 3:00, echo short axis view), we found moderate periprosthetic aortic insufficiency with worse mitral regurgitation. The left ventricle was small and hyperdynamic (ejection fraction >85%). The patient soon developed complete heart block, atrial fibrillation, and ventricular tachycardia. She was resuscitated with aggressive intravenous fluids, vasopressors, and an emergently placed atrioventricular sequential pacemaker. We postdilated the 26‐mm bioprosthesis with a 22‐mm Z‐Med balloon and subsequently with a 25‐mm balloon. Each balloon was inflated to its nominal volume and pressure and conformed the nitinol frame of the valve to the net circular shape and expected diameter. However, as soon as each balloon was deflated, the surrounding aortic root anatomy visibly recoiled and the frame returned to its smaller diameter with a distorted shape. A second 26‐mm CoreValve bioprosthesis was then deployed in a “valve‐in‐valve” configuration. Soon after, the patient's hemodynamics improved, her clinical condition stabilized, and she completely recovered. © 2016 Wiley Periodicals, Inc.     

Mixed aortic valve disease treated with transcatheter aortic valve replacement in a high risk patient presenting with acute decompensated heart failure

Mixed aortic valve disease refers to the combination of aortic regurgitation (AR) and aortic stenosis (AS). Commonly etiologies include a bicuspid aortic valve, rheumatic heart disease, and endocarditis superimposed upon a stenotic aortic valve. Treatment depends upon the severity of disease, the presence of symptoms and the size and function of the left ventricle. We present a case of a young patient that presented with new onset acute decompensated heart failure with mixed aortic valve disease that was successful treated with transcatheter aortic valve replacement (TAVR). Invasive hemodynamics at baseline and following TAVR provide an insight into the characteristic features of mixed aortic valve disease. TAVR represents a new treatment option for critically ill patients deemed high risk or nonoperable for surgical aortic valve replacement.     

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.     

Transfemoral transcatheter aortic valve implantation after aortic valve repair with HAART 300 device

We report the first successful case, to our knowledge, of CoreValve Evolut R (Medtronic, Minneapolis, MN) implantation into a failed HAART 300 aortic annuloplasty device (BioStable Science & Engineering, TX). An 81‐year‐old man presented with severe symptomatic aortic regurgitation secondary to failure of the 21 mm HAART 300 device, which had been implanted 45 days previously. Transthoracic echocardiography (TTE) revealed grade 3 aortic regurgitation with central jet, without aortic valve stenosis. Because of the high risk for redo surgery, the heart team proceeded with femoral transcatheter aortic valve implantation. The 26 mm CoreValve Evolut R was deployed into the 21 mm HAART 300 device without difficulty or complications. There were no intraoperative or postoperative complications. The patient was discharged after 5 days. TTE showed a mean aortic valve gradient of 18 mmHg, with minimal paravalvular leak. Our experience suggests that CoreValve Evolut R implantation may be an attractive option in patients with failed HAART 300 aortic annuloplasty.     

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.     

Fracture of small Mitroflow® aortic bioprosthesis following valve‐in‐valve transcatheter aortic valve replacement with ACURATE neo valve—From bench testing to clinical practice

Valve‐in‐valve (ViV) transcatheter procedures have emerged as a feasible, less‐invasive treatment option for bioprosthetic structural valve deterioration. However, in the presence of a small bioprosthesis, a significant residual gradient after ViV procedures often occurs and has been associated with poorer clinical outcomes. We report the use of the self‐expandable supra‐annular ACURATE neo? valve to treat degenerated Mitroflow (Sorin) aortic bioprosthesis with severe residual elevated gradients followed by valve fracture with a postdilation using a noncompliant balloon leading to significant reduction in residual gradients. In conclusion, the use of ACURATE neo? valve followed by the controlled fracture of the surgical bioprosthesis frame with a noncompliant balloon is a safe and effective approach for patients with Mitroflow® failing valves and residual elevated gradient after transcatheter aortic valve replacement.     

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。     

Valvuloplasty balloon entrapment in a self‐expanding aortic valve stent frame after inadvertent wire passage through the outflow struts

Transcatheter aortic valve replacement (TAVR) is a leading‐edge therapy option for patients with severe aortic stenosis (AS) and high surgical risk. However, this minimally invasive procedure is associated with specific complications that may be life‐threatening. Valvuloplasty balloon entrapment during postdilatation in transcatheter self‐expanding aortic valve stent frames has not yet been a focus of interest in this context. Although it is a rare event, it may critically influence outcome, and different management strategies can be considered. Hereafter, we present the case of a 67‐year‐old male who underwent transfemoral TAVR and subsequent postdilatation. The valvuloplasty balloon was entrapped in the self‐expanding aortic valve stent frame after inadvertent wire passage through the outflow struts. Since surgical risk was high, we preferred a percutaneous approach and extracted the entrapped balloon with high traction force under rapid pacing after valve stabilization with another balloon, which was placed in the annular position.     

The impact of mitral stenosis on outcomes of aortic valve stenosis patient undergoing surgical aortic valve replacement or transcatheter aortic valve replacement

Background

The concomitant presence of mitral stenosis (MS) in the setting of symptomatic aortic stenosis represent a clinical challenge. Little is known regarding the outcome of mitral stenosis (MS) patients undergoing transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR). Therefore, we sought to study the outcome of MS patients undergoing aortic valve replacement (AVR).

Method

Using weighted data from the National Inpatient Sample (NIS) database between 2011 and 2014, we identified patients who were diagnosed with MS. Patients who had undergone TAVR as a primary procedure were identified and compared to patients who had SAVR. Univariate and multivariate logistic regression analysis were performed for the outcomes of in‐hospital mortality, length of stay (LOS), blood transfusion, postprocedural hemorrhage, vascular, cardiac and respiratory complications, permanent pacemaker placement (PPM), postprocedural stroke, acute kidney injury (AKI), and discharge to an outside facility.

Results

A total of 4524 patients were diagnosed with MS, of which 552 (12.2%) had TAVR and 3972 (87.8%) had SAVR. TAVR patients were older (79.9 vs 70.0) with more females (67.4% vs 60.0%) and African American patients (7.7% vs 7.1%) (P < 0.001). In addition, the TAVR group had more comorbidities compared to SAVR in term of coronary artery disease (CAD), congestive heart failure (CHF), chronic lung disease, hypertension (HTN), chronic kidney disease (CKD), and peripheral vascular disease (PVD) (P < 0.001 for all). Using Multivariate logistic regression, and after adjusting for potential risk factors, TAVR patients had lower in‐hospital mortality (7.9% vs 8.1% adjusted Odds Ratio [aOR], 0.615; 95% confidence interval [CI], 0.392–0.964, P = 0.034), shorter LOS. Also, TAVR patients had lower rates of cardiac and respiratory complications, PPM, AKI, and discharge to an outside facility compared with the SAVR group.

Conclusion

In patients with severe aortic stenosis and concomitant mitral stenosis, TAVR is a safe and attractive option for patients undergoing AVR with less complications compared with SAVR.

     

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.     

Successful transfemoral aortic valve replacement in a bicuspid aortic stenotic valve: Requirements for a safe implant

Although transcatheter aortic valve replacement (TAVR) has been accepted as an attractive alternative for high‐risk patients with severe symptomatic aortic stenosis (AS), patients with congenital bicuspid AS has been typically disqualified for this indication due to an implied risk of device dislocation, distortion, or device malfunctioning. Nonetheless, bicuspid AS is not uncommon and frequently missed by transthoracic echocardiography. We reported an interesting case of a high‐risk patient with severe symptomatic bicuspid AS who underwent successful TAVR and discussed the anatomic requirements for a safe implant in patients with bicuspid AS considered candidates for TAVR. © 2013 Wiley Periodicals, Inc.     

A novel technique to manage transcatheter aortic valve embolization

We report a case of a 69-year-old male who was planned for a transcatheter aortic valve replacement (TAVR) with a 26 mm Sapien 3 Valve (Edwards Lifesciences, Irvine, California) for the treatment of symptomatic severe aortic stenosis. During rapid ventricular pacing and implantation of the TAVR valve, there was a loss of pacing capture and subsequent embolization of the valve into the aortic arch. Retrieval of the embolized valve was attempted unsuccessfully using several techniques. Finally, by using a 34 mm Evolut R Valve (Medtronic, Minneapolis, Minnesota), we were able to secure the embolized valve in the transverse segment of the aortic arch without compromising the branch vessels. To our knowledge, this is the first reported case of using a valve-in-valve approach to fixate an embolized valve in the transverse aorta.     

Balloon valuloplasty prior to transcatheter valve‐in‐valve implantation in a degenerated mitroflow aortic bioprosthesis

Transcatheter valve‐in‐valve implantation is an emerging treatment option for high‐risk patients with failing aortic bioprostheses. The presence of the prosthesis stents is thought to prevent coronary artery obstruction, a known complication of transcatheter aortic valve implantation in the native aortic valve. The Sorin Mitroflow aortic bioprosthesis (Sorin Group, Saluggia, Italy) has a particular design in that the pericardial leaflets are mounted outside the valve stent. As a consequence, the pericardial leaflets of this prosthesis may be displaced well away from the stents during the deployment of transcatheter valves. This might explain why both the cases of coronary occlusion following valve‐in‐valve implantation reported to date occurred in patients with a malfunctioning Mitroflow bioprosthesis. We describe a patient with a malfunctioning 25 mm Mitroflow bioprosthesis successfully treated by percutaneous transcatheter valve‐in‐valve implantation, and discuss the role that balloon aortic valvuloplasty plays in the performance of this delicate procedure. © 2012 Wiley Periodicals, Inc.     

Transcatheter aortic valve replacement in elderly patients

Aortic stenosis is the most common native valve disease, affecting up to 5% of the elderly population. Surgical aortic valve replacement reduces symptoms and improves survival, and is the definitive therapy in patients with symptomatic severe aortic stenosis. However, despite the good results of classic surgery, risk is markedly increased in elderly patients with co-morbidities. Transcatheter aortic valve replacement (TAVR) allows implantation of a prosthetic heart valve within the diseased native aortic valve without the need for open heart surgery and cardiopulmonary bypass, offering a new therapeutic option to elderly patients considered at high surgical risk or with contraindications to surgery. To date, several multicenter registries and a randomized trial have confirmed the safety and efficacy of TAVR in those patients. In this chapter, we review the background and clinical applications of TAVR in elderly patients.     

Complications after Transfemoral Transcatheter Aortic Valve Replacement with a Balloon‐Expandable Prosthesis: The Importance of Preventative Measures and Contingency Planning

Transcatheter aortic valve replacement (TAVR) with balloon‐expandable Edwards‐SAPIEN valve was superior to standard therapy in inoperable patients and noninferior to surgical aortic valve replacement in high surgical‐risk, but operable patients, with severe symptomatic aortic stenosis in the randomized controlled PARTNER trial. Since the first case of TAVR with a balloon‐expandable valve in 2002, several groups have reported their experience with balloon‐expandable valves with high‐procedural success. In the United States, the balloon‐expandable Edwards‐SAPIEN valve is the only transcatheter heart valve approved by the FDA for commercial use. Moreover, this is only in high‐risk inoperable patients. Despite increasing experience with the TAVR procedure, it can be associated with complications, which can be technically challenging, even for an experienced operator. Complications associated with TAVR include vascular complications, valve malpositioning, regurgitation, embolization, coronary compromise, conduction abnormalities, stroke/transient ischemic attack, acute kidney injury, cardiac tamponade, and hemodynamic collapse. A thorough understanding of the procedure is essential for pre‐emptive planning for procedural complications and early identification and management of complications are necessary for procedural success. We hereby review our experience of transfemoral TAVR with balloon‐expandable valves, offer practical tips to maximize the likelihood of procedural success, describe pre‐emptive strategies to prevent peri‐procedural complications and bailout measures to manage them, should they occur. © 2018 Wiley Periodicals, Inc.     

Transcatheter aortic valve replacement: The year in review 2016

Transcatheter aortic valve replacement (TAVR) continued to make major strides in 2016, simultaneously expanding its application to lower risk patients as well as more technically challenging subsets of patients with aortic stenosis (AS). The two major accomplishments this year were the establishment of TAVR as the preferred treatment strategy over surgical aortic valve replacement (SAVR) in intermediate risk patients, and initial signals that TAVR and SAVR may be clinically equivalent in low‐risk populations. Meanwhile, there is continued expansion of TAVR to challenging clinical subsets (bicuspid aortic valve [BAV], patients with concomitant advanced coronary artery disease [CAD], and failed surgical bioprostheses), and encouraging initial experiences with newer transcatheter heart valve systems. This paper summarizes the major research studies published on TAVR in 2016.

     

Transcatheter versus surgical aortic valve replacement in severe, symptomatic aortic stenosis

Aortic stenosis (AS) is the most common type of valvular heart disease in the elderly. Surgical aortic valve replacement (SAVR) has been the standard practice for treating severe, symptomatic AS, but recently new treatment options have emerged. Transcatheter aortic valve replacement (TAVR) is now an established treatment option in patients at high surgical risk. In this review, we focus on recent developments and compare the two treatment methods in specific populations in terms of efficacy and safety (e.g., in patients with history of prior thoracic surgery, type of anesthesia employed, access site used or need for permanent pacing). The impact of comorbidities (pulmonary hypertension, arterial hypertension and obesity paradox), the cost-effectiveness of TAVR vs. SAVR and advances in transcatheter valve technology as well as issues that merit further investigation are further discussed. Moreover, outcomes and complications of TAVR in patients of different risk category (extremely high, high, intermediate and low risk) are analyzed. We strongly believe that during the following years, TAVR may evolve as the treatment of choice in a broader group of patients with symptomatic AS and beyond those with intermediate and high-risk features.     

Valve‐in‐valve transcatheter aortic valve replacement to treat multijet paravalvular regurgitation: A case series and review

Treatment advances for severe symptomatic aortic stenosis including transcatheter and open surgical valve replacement have improved patient survival, length of stay, and speed to recovery. However, paravalvular regurgitation (PVR) is occasionally seen and when moderate or greater in severity is associated with an at least 2‐fold increase in 1 year mortality. While several treatment approaches focused on single‐jet PVR have been described in the literature, few reports describe multijet PVR. Multijet PVR can successfully be treated with a variety of catheter‐based options including valve‐in‐valve (ViV) transcatheter aortic valve replacement (TAVR). We present two patients with at least moderate PVR following aortic valve replacement who were successfully treated with ViV TAVR along with a review of literature highlighting our rationale for utilizing each management approach. Multijet PVR can be treated successfully with ViV TAVR, but additional options such as self‐expanding occluder devices and bioprosthetic valve fracture have a role as adjunctive treatments to achieve optimal results. The etiology of multijet PVR can differ between patients, this heterogeneity underscores the paucity of data to guide treatment strategies. Therefore, successful treatment of multijet PVR requires familiarity with available therapeutic options to achieve optimal results and, by extension, decrease patient mortality.