Successful treatment of a paravalvular leak with balloon cracking and valve‐in‐valve TAVR

Transcatheter heart valve implantation into degenerated bioprosthetic valves (ViV‐THV implantation) has become an established procedure for high risk patients. In general, paravalvular leak (PVL) is a contraindication for valve‐in‐valve‐TAVR (ViV‐TAVR). Herein, we report on a 81‐year‐old patient presenting with acute heart failure for a failing aortic bioprosthesis (Medtronic Mosaic 27 mm). Intraoperative transesophageal echocardiography during urgent ViV‐TAVR revealed a PVL previously not detected. After transfemoral implantation of a 26 mm‐Evolut‐R, balloon‐fracturing of the bioprosthetic ring was performed using a 24 mm True Dilatation balloon for treatment of the PVL. Afterward, left ventricular to aortic peak‐to‐peak pressure gradient measured 2–4mmHg. Transesophageal echocardiography merely revealed trace PVL. Aortic root angiography showed no PVL. At discharge, echocardiography measured a transprosthetic mean gradient of 5mmHg detecting no PVL. Intentional ring‐fracturing of an aortic valve prostheses may prove not only to be effective in lowering transvalvular gradients after valve‐in‐valve‐TAVR, but may also be a tool to treat PVL alongside degenerated surgical aortic bioprostheses in certain patients.     

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.     

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.     

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.     

Bioprosthetic aortic valve leaflet disruption with high energy electrocautery to prevent coronary artery obstruction during valve‐in‐valve transcatheter aortic valve replacement

Transcatheter aortic valve replacement (TAVR) is well‐established for the treatment of bioprosthetic aortic valve stenosis (AS) in high surgical risk patients. Coronary artery obstruction from displacement of the bioprosthetic valve leaflets during valve‐in‐valve (VIV) TAVR is a rare, but potentially fatal, complication. Recently, the bioprosthetic aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction (BASILICA) procedure was developed as a method for disrupting bioprosthetic leaflets in patients undergoing VIV TAVR at high risk for coronary obstruction. This case describes a successful VIV TAVR utilizing a simplified concept of the BASILICA technique in a patient where the full procedure could not be completed.     

Transcatheter aortic valve replacement in unicuspid aortic valve stenosis

Unicuspid aortic valve (UAV) offers unique challenges to transcatheter aortic valve replacement (TAVR), due to asymmetric expansion and apposition of the prosthesis during implantation. Although TAVR in bicuspid is now a well described experience, TAVR in unicuspid valve has not yet been described. A challenging case is described with TAVR in UAV using a Edwards Sapiens prosthesis via transapical approach. © 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.     

Echocardiography in transcatheter aortic (Core)Valve implantation: Part 2—Transesophageal echocardiography

Transesophageal echocardiography (TEE) plays a significant role during transcatheter aortic valve implantation (TAVR). 2DTEE allows assessment of anatomy of the aortic valve, aortic root, left ventricular (LV) outflow tract, severity of the aortic valve stenosis (AS), and the presence and severity of other valve stenosis and regurgitation. Left and right ventricular size and global function as well as cardiac hemodynamics pre and post TAVR and LV regional wall motion can be assessed. Three‐dimensional (3D) imaging adds significantly via accurate measurement of aortic annulus that helps select the appropriate valve size. Biplane imaging allows simultaneous assessment of target cardiac structure in two orthogonal views and provides a rapid assessment during and immediately post valve deployment by evaluating stent height, leaflet motion, and the presence and severity of paravalvular leak (PVL). 2DTEE and 3DTEE allow evaluation of mechanism of PVL that helps guide the decision regarding need for balloon post dilation of the implanted valve or valve in valve implantation.     

Contemporary transcatheter aortic valve replacement with third‐generation balloon‐expandable versus self‐expanding devices

Objectives

To evaluate balloon‐expandable and self‐expanding third‐generation transcatheter aortic valve replacement (TAVR) devices according to patient selection criteria and outcomes.

Background

Two competing third‐generation TAVR technologies are currently commercially available in the US. There are no published head‐to‐head comparisons of the relative performance of these two devices.

Methods

257 consecutive patients undergoing TAVR with a third‐generation balloon‐expandable (Edwards Sapien 3) or self‐expanding device (Medtronic CoreValve Evolut R) at a single US medical center were included. Choice of TAVR device was at the discretion of the multidisciplinary Heart Team. Baseline clinical characteristics, echocardiographic and CT imaging, procedural and 30‐day outcomes were prospectively collected.

Results

74 patients received a self‐expanding valve (SEV) and 183 received a balloon‐expandable valve (BEV). Patients selected for SEV were more frequently women, with lower body surface area and smaller calcified iliofemoral arteries. Three SEV patients required implantation of a second valve to successfully treat paravalvular leak. Only one BEV patient had moderate paravalvular regurgitation. There was no difference in the rate of stroke, major vascular complication or bleeding. Permanent pacemaker implantation rate was significantly higher with SEV (12.7% vs 4.7%, P = 0.49) and hospital length of stay was longer (8.3% vs 6.5%, P = 0.043), but 30‐day mortality was comparable (1.4% vs 1.6%, P = 1.00).

Conclusions

Short‐term outcomes were equivalent between the two technologies. Clinically significant paravalvular regurgitation was rare. SEV were more frequently selected in women and patients with challenging transfemoral access, but were associated with higher permanent pacemaker implantation rate and longer hospital length of stay.

     

Echocardiographic follow‐up after transcatheter aortic valve replacement

The use of transcatheter aortic valve replacement (TAVR) for high‐risk patients with aortic stenosis has rapidly increased during the past years. Accordingly, more and more patients are referred for a follow‐up echocardiographic study after TAVR. However, the echocardiographic evaluation of patients who underwent TAVR places specific demands on echocardiographers. Furthermore, TAVR may be associated with new types of complications, which are frequently unrecognized or underestimated due to lack of familiarity with the normal and pathological appearance of TAVR. Therefore, this review summarizes the echocardiographic parameters describing the structural and functional status of bioprostheses used in TAVR, procedures taking into account their peculiar hemodynamics. We also describe the strengths and the limitations of echocardiography and of other imaging modalities in detecting long‐term complications of TAVR (eg, infective endocarditis, thrombosis). The aim of this review was to serve as a guide for a structured echocardiographic follow‐up of TAVR patients, as well as for the echocardiographic diagnosis of the procedure‐associated complications.     

Transcatheter aortic valve implantation 10 years after valve‐in‐valve transcatheter aortic valve implantation for failing aortic valve homograft root replacement

Valve‐in‐valve transcatheter aortic valve implantation (ViV‐TAVI) is an established therapy for a degenerated surgical bioprosthesis. TAVI‐in‐TAVI following ViV‐TAVI has not been previously performed. We report a high‐risk patient presenting with severe left ventricular failure secondary to undiagnosed critical aortic stenosis due to degeneration of the implanted transcatheter heart valve more than a decade after initial ViV‐TAVI for a failing stentless aortic valve homograft. Successful TAVI‐in‐TAVI reversed the clinical and echocardiographic changes of decompensated heart failure with no evidence of coronary obstruction.     

Meta‐analysis of complications in aortic valve replacement: Comparison of Medtronic‐Corevalve,Edwards‐Sapien and surgical aortic valve replacement in 8,536 patients

Background : We sought to establish the complication rates following transcatheter aortic valve replacement (TAVR) in the context of high risk and octogenarian surgical aortic valve replacement (SAVR) in the contemporary literature, and to critically analyze population characteristics and outcomes. Methods : TAVR studies were selected from nonoverlapping series and SAVR studies for comparison if they met similar entry criteria. Bayesian meta‐analytic methods were employed. Results : For the 5024 TAVR and 3512 SAVR patients included in the study, TAVR subjects had greater baseline renal impairment (P < 0.001), a higher incidence of prior myocardial infarction (P = 0.032) and respiratory disease (P = 0.005) and a higher logistic EuroSCORE (P = 0.039). There were no significant differences observed in complications studied in SAVR and TAVR: 30 day mortality (9% vs 8.5%, P = 0.31), 1 year mortality (18.4% vs 22.8%, P = 0.65), 30 day stroke (2.4% vs 2.6%, P = 0.72), new permanent pacemaker (5.9% vs 12.1%, P = 0.055) and dialysis inception (2.4% vs 4.1%, P = 0.70). We also compared demographics and outcomes between the two types of transcatheter valves. Apart from some variation in functional status, there were no significant differences at baseline with different TAVR designs. The only difference in complications was the need for pacemaker insertion, higher with the Medtronic‐Corevalve than with the Edwards‐Sapien design (24.5% vs 5.9% P < 0.0001). Conclusions : Complications for elderly and high risk aortic stenosis patients being treated by TAVR appear comparable to those selected for SAVR in the real‐world. © 2012 Wiley Periodicals, Inc.     

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.     

Transcatheter vs surgical aortic‐valve replacement in low‐ to intermediate‐surgical‐risk candidates: A meta‐analysis and systematic review

The American and European expert documents recommend transcatheter aortic valve replacement (TAVR) for inoperable or high‐surgical‐risk patients with severe aortic stenosis. In comparison, efficacy of TAVR is relatively less studied in low‐ to intermediate‐surgical‐risk patients. We sought to discover whether TAVR can be as effective as surgical aortic valve replacement (SAVR) in low‐ to intermediate‐surgical‐risk candidates. Four randomized clinical trials (RCTs) and 8 prospective matched studies were selected using PubMed/MEDLINE, Embase, and Cochrane Library (inception: March 2017). Results were reported as random‐effects odds ratio (OR) with 95% confidence interval (CI). Among 9851 patients, analyses of RCTs showed that all‐cause mortality was comparable between TAVR and SAVR (short term, OR: 1.19, 95% CI: 0.86‐1.64, P = 0.30; mid‐term, OR: 0.97, 95% CI: 0.75‐1.26, P = 0.84; and long term, OR: 0.97, 95% CI: 0.81‐1.16, P = 0.76). The analysis restricted to matched studies showed similar outcomes. In the analysis stratified by study design, no significant differences were noted in the RCTs for stroke, whereas TAVR was better than SAVR in matched studies at short term only (OR: 0.46, 95% CI: 0.33‐0.65, P < 0.001). TAVR is associated with reduced risk of acute kidney injury and new‐onset atrial fibrillation (P < 0.05). However, increased incidence of permanent pacemaker implantation and paravalvular leaks was observed with TAVR. TAVR can provide similar mortality outcome compared with SAVR in low‐ to intermediate‐surgical‐risk patients with critical aortic stenosis. However, both procedures are associated with their own array of adverse events.     

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.     

Percutaneous closure of acute aorto‐right ventricular fistula following transcatheter bicuspid aortic valve replacement

We report a case of acute aorto‐right ventricular fistula following transcatheter bicuspid aortic valve replacement and subsequent percutaneous closure. The diagnosis and treatment of this rare complication is illustrated through multi‐modality imaging. We hypothesize that the patient's heavily calcified bicuspid aortic valve anatomy led to asymmetric deployment of the transcatheter aortic valve replacement (TAVR) prosthesis, traumatizing the right sinus of Valsalva at the distal edge of the TAVR stent and ultimately fistulized to the right ventricle. The patient acutely decompensated with heart failure five days after TAVR and underwent emergent intervention. The aorto‐right ventricular fistula was closed using an 18‐mm septal occluder device with marked clinical recovery. Transcatheter closure is a viable treatment option for acute aorto‐right ventricular fistula. © 2016 Wiley Periodicals, Inc.     

First‐in‐human valve‐in‐valve implantation of a 20 mm balloon expandable transcatheter heart valve

An 86‐year‐old lady with recurrent admissions for heart failure due to a severely regurgitant aortic bioprosthesis (SJM Epic 19 mm) was not a candidate for re‐operation due to age and frailty. Her small ilio‐femoral arteries precluded a transfemoral transcatheter valve‐in‐valve (VIV) approach. The small internal diameter of her bioprosthesis (16 mm) forbids the implantation of the smallest available transapical transcatheter heart valve (THV). We, therefore, decided to perform a first‐in‐human transapical aortic VIV implantation using a 20 mm balloon expandable THV and a transfemoral delivery system. The procedure was successfully performed under general anesthesia, without any contrast dye and under fluoroscopy as well as transesophageal echocardiography guidance. The post‐procedural transvalvular gradient was 15 mm Hg (pre‐procedural 14 mm Hg). At 30‐day follow‐up, the lady was living independently at home without shortness of breath during her daily activities. If redo‐surgery for prosthetic regurgitation is not an option, VIV implantation in very small surgical bioprosthesis is feasible and leads to acceptable hemodynamics and clinical improvement.© 2012 Wiley Periodicals, Inc.     

Series of transcatheter valve‐in‐valve implantations in high‐risk patients with degenerated bioprostheses in aortic and mitral position

Objectives: We report our experience with transcatheter valve‐in‐valve implantations in patients with degenerated bioprostheses in aortic and mitral position. Background: Xenograft degeneration is a potential problem after biological valve replacement. Reoperation remains the gold standard with very good short‐ and long‐term results. In selected patients not suitable for surgery however, interventional techniques for valve implantation and repair may be valuable alternative treatment options with regard to the good results of transcatheter valve implantation for native aortic valve stenosis. Methods: Five patients presented with significant xenograft degeneration 15.4 ± 5.2 years after aortic (n = 4) and mitral (n = 1) valve replacement. Mean patient age was 82.0 ± 6.5 years and predicted operative mortality was 55.8% ± 18.9% (logistic EuroSCORE). Transcatheter valve‐in‐valve implantation was performed successfully through a transapical access in all patients. A 23‐mm Edwards Sapien valve was deployed into the degenerated valve prosthesis. Results: Mean transvalvular gradients were reduced from 31.2 ± 17.4 to 19.0 ± 12.4 mm Hg in aortic and from 9 to 3 mm Hg in mitral position without significant regurgitation in any of these patients. Two patients died within 30 days due to low cardiac output and acute hemorrhage, respectively, one of whom presented with a EuroSCORE of 88.9%. Conclusions: With growing need for reoperative valve replacement in elderly patients with disproportional operative risks, transcatheter valve‐in‐valve implantation in aortic and mitral position offers an alternative treatment option. Although valve function after transcatheter implantation was good in all patients, two high risk patients died in the postoperative period due to their significant comorbidities, underscoring the bail‐out character of this procedure. © 2010 Wiley‐Liss, Inc.     

Transcatheter aortic valve replacement and stroke: a comprehensive review

Transcatheter aortic valve implantation (TAVR) has emerged as an alternative, rapidly evolving treatment option for patients with severe aortic stenosis and high surgical risk. Stroke is a devastating complication being confined mainly in the periprocedural and 30-day period following TAVR, with a lower and relatively constant frequency thereafter. Early stroke is mainly due to debris embolization during the procedure, whereas later events are associated with patient specific factors. Despite the fact that the rate of clinical stroke has been constantly decreasing compared to initial TAVR experience, modern neuro-imaging with MRI suggests that new ischemic lesions post-TAVR are almost universal. The impact of the latter is largely unknown. However, they seem to correlate with a reduction in neurocognitive function. Because TAVR is set to expand its indication to lower surgical-risk patients, stroke prophylaxis during and after TAVR becomes of paramount importance. Based on clinical and pathophysiological evidence, three lines of research are actively employed towards this direction: improvement in valve and delivery system technology with an aim to reduce manipulations and contact with the calcified aortic arch and native valve, antithrombotic therapy, and embolic protection devices. Careful patient selection, design of the procedure, and tailored antithrombotic strategies respecting the bleeding risks of this fragile population constitute the main defense against stroke following TAVR.     

Direct comparison of rapid deployment versus sutureless aortic valve replacement: a meta-analysis

BackgroundThis meta-analysis was conducted to compare the procedural and early outcomes of aortic valve replacement (AVR) using rapid deployment valve (RD group) versus sutureless valve (SU group).MethodsA literature search of 5 online databases was conducted. The primary outcomes were mean transvalvular pressure gradient (MPG) after AVR, the incidence of paravalvular leak (PVL) and the need for a permanent pacemaker implantation (PPI). The secondary outcomes included aortic cross-clamp (ACC) and cardiopulmonary bypass (CPB) times, early mortality and other postoperative complications, such as atrial fibrillation, bleeding reoperation and stroke.ResultsEight articles were included, and all outcomes except MPG after AVR in matched valve sizes were extracted from 7 studies (RD group =842 patients and SU group =1,386 patients). The pooled analysis demonstrated a lower MPG in the RD group than in the SU group, with mean difference (MD) of 2.64 mmHg. The pooled risk ratios of any PVL and grade ≥2 (or moderate) PVL were not significantly different between the groups; however, the incidence of PPI was significantly lower in the RD group than in the SU group, with a risk ratio of 0.69. The pooled analyses showed that the ACC and CPB times were significantly longer in the RD group than in the SU group, with weighted MDs of 8.74 (P<0.001) and 9.94 (P<0.001) minutes, respectively. The risks of early mortality and other postoperative complications were not significantly different between the groups.ConclusionsAVR using RD valve was associated with better valve hemodynamics in terms of the MPG than AVR using SU valve, and better outcomes were observed in the RD group regarding PPI. Procedural times were longer in AVR using RD valve than SU valve. Early clinical outcomes showed no difference between RD and SU valve.