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.     

Valve‐in‐valve implantation with a 23‐mm balloon‐expandable transcatheter heart valve for the treatment of a 19‐mm stentless bioprosthesis severe aortic regurgitation using a strategy of “extreme” underfilling

We report a case of valve‐in‐valve (ViV) implantation by transfemoral approach with a 23‐mm balloon‐expandable prosthesis inside a stentless 19‐mm acutely degenerated bioprosthesis, using a strategy of “extreme” underfilling. A 74‐year‐old patient presented to our institution in cardiogenic shock. An initial transesophageal echocardiography (TEE) showed severe central aortic regurgitation (AR) due to a torn leaflet. She was deemed inoperable and considered for urgent transcatheter aortic valve replacement. Given the fairly small true internal diameter, a strategy of 3‐cc underfilling of a 23‐mm transcatheter heart valve (THV) was planned. However, the final implantation was performed with 5‐cc underfilling due to the incapacity to deliver the entire amount of fluid contained in the inflation syringe. TEE guidance confirmed the successful positioning and deployment of the prosthesis, with no AR and a mean gradient of 25 mm Hg. While implantation of a smaller prosthesis (20 mm) was debated during the Heart Team discussion, the risk of valve embolization due to inadequate anchoring inside the stentless prosthesis led to the selection of a 23‐mm THV. At 6‐month follow‐up, the patient was in NYHA class I, with no AR and a mean gradient of 28 mm Hg. We report for the first time the use of in vivo THV with 5‐cc underfilling with no acute or short‐term structural failure, and the first ViV implantation by transfemoral approach with a 23‐mm balloon‐expandable prosthesis inside a stentless 19‐mm bioprosthesis. The current report presents the challenges related to ViV implantation inside a small stentless bioprosthesis and offers practical ways to overcome them. © 2014 Wiley Periodicals, Inc.     

Transaortic transcatheter aortic valve implantation within a previous bioprosthetic aortic valve replacement

This report documents the first reported case of transaortic transcatheter aortic valve implantation (TAVI) using the CoreValve ReValving system (Medtronic CoreValve System, Luxembourg), within a previous bioprosthetic aortic valve replacement. TAVI has become a recognized percutaneous treatment for patients with severe native or bioprosthetic aortic valve stenosis. However, as the number of patients screened for TAVI increases, a number of patients are found with absolutely no option for peripheral arterial access, either from the femoral or subclavian routes. Transaortic CoreValve placement offers an alternate minimally invasive hybrid surgical/interventional technique when peripheral access is not possible. A CoreValve prosthesis was implanted via the transaortic route in an 81‐year‐old woman with severe bioprosthetic aortic valve stenosis (21 mm Mitroflow pericardial valve, peak instantaneous gradient of 99 mmHg, effective valve orifice area (EOA) of 0.3 cm², as ilio‐femoral and left subclavian angiography revealed small calibre vessels (<6 mm). Access was achieved via a mini thoracotomy via the left anterior second intercostal space. The procedure went without complication. Post procedure the patient was transferred directly to the Cardiac Care Unit for recuperation. Post procedure echocardiography showed that the TAVI was well positioned with no para‐valvular leak and a reduction in peak instantaneous gradient to 30 mmHg and an increase in EOA to 1.5 cm². She was discharged on the third post‐procedural day in sinus rhythm with a narrow QRS complex. CoreValve implantation within previous surgical bioprosthesis is now an established treatment. The transaortic approach to transcatheter implantation is a promising recent development, when due to anatomical reasons, transfemoral or subclavian TAVI is not feasible. © 2011 Wiley‐Liss, Inc.     

Coronary obstruction following transcatheter aortic valve‐in‐valve implantation for failed surgical bioprostheses

Transcatheter aortic valve implantation (TAVI) for failed surgical bioprostheses, or “valve‐in‐valve” implantation, is a therapeutic option for high‐risk patients. While coronary occlusion during TAVI for native aortic stenosis has been described, in the setting of valve‐in‐valve implantation the bioprsthetic posts may be protective against this complication. We describe the first two cases of coronary occlusion following valve‐in‐valve therapy, both occurring during treatment of degenerated Mitroflow bioprostheses. Aortic root anatomy, coronary ostial position, and the specifics of the bioprosthetic valve type need to be considered in assessing and preventing this rare complication. © 2011 Wiley‐Liss, Inc.     

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.     

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.     

Urgent trans‐axillary valve‐in‐valve procedure using the Edwards 16‐F expandable introducer

Transcatheter aortic valve implantation could represent an alternative option to conventional surgery in high‐risk patients with degeneration of aortic bioprosthesis. Herein, we report the performance of a valve‐in‐valve procedure in urgent conditions and via the left axillary artery in a patient with patent left internal mammary artery coronary graft. A 23‐mm Edwards Sapien^® transcatheter valve was deployed within a 23‐mm Edwards Magna Ease bioprosthesis through the novel Edwards 16‐F expandable introducer. In this non‐elective case, the expandable introducer allowed a safe procedure, reduced the risk of subclavian injury, and preserved the left internal mammary artery graft flow. © 2012 Wiley Periodicals, Inc.     

The valve‐in‐valve technique: Transcatheter treatment of aortic bioprothesis malposition

Percutaneous aortic valve replacement is an emerging alternative to palliative medical therapy for nonsurgical patients with severe aortic valve stenosis. The impossibility of repositioning of the current transcatheter prosthesis in case of suboptimal placement is the main limit of these devices. Here, we report on a case of an 84‐year‐old woman successfully treated with implantation of two 18‐Fr CoreValve® prosthesis (CoreValve®, Irvine, California), because of the suboptimal deployment of the first one, analyzing the procedural technique and the immediate and short‐term clinical and hemodynamic results. © 2009 Wiley‐Liss, Inc.     

First trans‐axillary implantation of Edwards Sapien valve to treat an incompetent aortic bioprosthesis

There exist case reports of using transcatheter aortic valves to treat dysfunctional surgically implanted aortic bioprosthesis. There are also case series reported of transaxillary implantation of the CoreValve device to treat Aortic Stenosis. In this article, we report the successful implantation an Edwards Sapien 23mm transcatheter aortic valve through the left axillary artery, in a patient with a functioning LIMA graft in order to treat a severely regurgitant Freestyle 23mm aortic bioprosthesis. © 2009 Wiley‐Liss, 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.     

A guide to fluoroscopic identification and design of bioprosthetic valves: A reference for valve‐in‐valve procedure

Surgical aortic valve replacement remains the therapy of choice in majority of patients with aortic stenosis. Bioprosthetic heart valves are often preferred over mechanical valves as they preclude the need for anticoagulation with its associated risks of bleeding and thromboembolism. However, bioprosthetic heart valves undergo structural deterioration and eventually fail. Reoperation is the standard treatment for structural failure of the bioprosthetic valve, stenosis or regurgitation but can carry a significant risk, especially in elderly patients with multiple comorbidities. Transcatheter aortic valve implantation has recently been established as a feasible alternative to conventional valve surgery for the management of high‐risk elderly patients with aortic stenosis. This treatment modality has also been shown to be of benefit in the management of degenerated aortic bioprosthesis as a valve‐in‐valve procedure. The success of this procedure depends on a good understanding of the failing bioprostheses. This not only includes the device design but its radiological/fluoroscopic appearance and how it correlates with the implanted valve, as transcatheter aortic valve implantation is performed under fluoroscopic guidance. Here we illustrate the fluoroscopic appearance of 11 commercially available surgical bioprostheses and two commercially available transcatheter heart valves and discuss important aspects in their design which can influence outcome of a valve‐in‐valve procedure. We have also collated relevant information on the aspects of the design of a bioprosthetic valve, which are relevant to the valve‐in‐valve procedure. © 2012 Wiley Periodicals, Inc.     

Implantation of two self‐expanding aortic bioprosthetic valves during the same procedure—Insights into valve‐in‐valve implantation (“Russian doll concept”)

Transcatheter aortic value implantation has gained acceptance as a treatment for elderly patients considered high risk for surgical aortic valve replacement. There are still, however, many unresolved clinical and technical issues. The occurrence of transcatheter aortic valve‐in‐valve implantation has been reported anecdotally. Aside from a single case report, there is little literature on this topic. This study was conducted to evaluate the procedural, imaging, and clinical outcomes of patients who underwent transcatheter valve‐in‐valve implantation with two self‐expanding aortic valve bioprostheses during the same procedure. We discuss also the potential valve of on‐line quantitative angiography for assessing the depth of valve implantation and the need to implant a second valve. © 2009 Wiley‐Liss, Inc.     

Transcatheter aortic valve implantation for treatment of patients with degenerated aortic bioprostheses—valve‐in‐valve technique

Background: The management of patients with degeneration of surgical bioprosthetic valve replacement remains a challenge because of the higher risk of re‐do aortic valve replacement. We present a case series of five patients with degenerated aortic bioprostheses treated with transfemoral transcatheter aortic valve implantation (TAVI). Methods: From December 2009 to May 2010, five patients with degenerated aortic valve bioprostheses (aortic valve area < 1 cm² or severe aortic regurgitation), an excessive operative risk (EuroSCORE ≥ 30%), symptoms of heart failure (NYHA ≥ III) and an internal diameter of bioprosthetic aortic valve 20.5 ± 0.5 mm were included. Procedures were performed without hemodynamic support using femoral arteries. Balloon valvuloplasty with a 20‐mm balloon under rapid pacing was carried out before valve implantation. The 26‐mm CoreValve prosthesis, 18‐F‐generation (Medtronic, Minneapolis, Minnesota) was inserted retrograde under fluoroscopic guidance. Invasive and echocardiographic measurements were done immediately before and after TAVI. Clinical followup and echocardiography were performed after procedure (mean followup 72 days ± 60, range: 176–30 days). Results: In all patients TAVI was successful with immediate decrease of transaortic peak‐to‐peak pressure (P = 0.002). Mild aortic regurgitation occurred in two patients and one patient received a new permanent pacemaker. Major adverse cardiac and cerebrovascular events did not arise. NYHA functional class improved in all patients and left ventricular ejection fraction increased (P = 0.019). Conclusion: Our experiences with the valve‐in‐valve technique using the CoreValve prosthesis suggest that transfemoral TAVI is feasible in high risk patients with degenerated aortic bioprostheses. © 2010 Wiley‐Liss, Inc.     

Performance of valve-in-valve for severe para-prosthetic leaks due to inadequate transcatheter aortic valve implantation

Objectives : This study reports on mid‐term safety and performance of valve‐in‐valve implantation as rescue strategy to overcome acute PPL after TAVI. Background. Moderate to severe para‐prosthetic leaks (PPL) after transcatheter aortic valve implantation (TAVI) have been described with both self‐expandable and balloon‐expandable device.Methods : We analyzed data regarding patients who underwent valve‐in‐valve implantation, enrolled in the ongoing single‐center prospective registry of TAVI, the Padova University REVALVing experience Registry. All procedures were performed by a totally percutaneous approach, using the self‐expanding Medtronic CoreValve (Medtronic, Minneapolis, MN). Results : Out of 87 patients who underwent TAVI, six received valve‐in‐valve implantation because of persisting severe PPL, due to prosthesis malposition. In all patients, the second device was successfully deployed, with a significant reduction in aortic regurgitation: PPL was no longer appreciable in two of six patients, and it decreased from severe to mild or trivial in four patients. Four patients developed atrio‐ventricular block requiring pace‐maker implantation. At follow‐up (6–24 months) two patients died, whereas no prosthesis‐related death occurred. Transprosthesis pressure gradient, effective orifice area, and aortic regurgitation did not change at serial echocardiograms throughout the follow‐up. Conclusions : Valve‐in‐valve implantation using self‐expandable bioprosthesis seems safe and highly effective to overcome severe PPL due to prosthesis malposition early after TAVI. Moreover, the implantation of two valves does not affect the performance of prosthesis at follow‐up. © 2011 Wiley Periodicals, Inc.     

Simultaneous transapical aortic and mitral valve‐in‐valve implantation for double prostheses dysfunction: Case report and technical insights

Transcatheter “Valve‐in‐Valve” implantation (ViV) has shown promising results in high‐risk patients suffering from structural valve deterioration (SVD) of a previously implanted heart valve bioprosthesis. We present a case of a 68‐year‐old woman with a history of three previous cardiac operations on the aortic and mitral valve. At the time of admission she was severely symptomatic due to a simultaneous SVD of a 23 mm aortic and of a 29 mm mitral St. Jude Biocor bioprosthesis. Because of the history of several cardiac operations and to her comorbidities, the patient was considered with an extremely high surgical risk profile and was therefore scheduled for double concomitant mitral and aortic ViV. Through a trans‐apical approach, the patient underwent 23 and 29 mm Edwards Sapien XT implantation in the aortic and mitral bioprosthesis, respectively. The procedure was uneventful as well as the following hospital stay. At 6‐months follow‐up the patient is in NYHA class I. Echocardiography shows that the aortic bioprosthesis has no leak and the mean gradient is 20 mm Hg while the mitral valve has mild leak and maximum and mean gradients are 21 and 10 mm Hg, respectively. The three main technical aspects that should be carefully considered in double concomitant ViV are: sequence of valve deployment (whether to implant the mitral or the aortic valve first), choice of access and valve sizing. In conclusion, double simultaneous trans‐apical mitral and aortic ViV is technically feasible. © 2014 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.     

Bioprosthetic Valve Leaflet Displacement During Valve-in-Valve Intervention: An Ex Vivo Bench Study

ObjectivesThe aim of this study was to examine the effect of different transcatheter heart valves (THVs) on valve leaflet displacement when deployed within bioprosthetic surgical valves and, thereby, risk for coronary obstruction.BackgroundCoronary obstruction is a potentially devastating complication during valve-in-valve (ViV) transcatheter aortic valve replacement. Strategies such as provisional stenting and intentional bioprosthetic valve leaflet laceration have been developed to mitigate this risk. Alternatively, the use of a THV that retracts the bioprosthetic leaflet away from the coronary ostium may prevent coronary obstruction.MethodsA 25-mm J-Valve, a 26-mm Evolut Pro, and a 23-mm JenaValve were implanted into both a 25-mm Trifecta surgical valve and a 25-mm Mitroflow surgical valve. A 23-mm and a 26-mm SAPIEN 3 were deployed into the Trifecta and Mitroflow, respectively. Displacement of the surgical valve leaflets (retraction vs. expansion) was measured with implantation of each THV by measuring displacement angle and maximal displacement distance.ResultsWithin both the Trifecta and Mitroflow valves, implantation of the J-Valve and JenaValve resulted in retraction of the surgical valve leaflets, and placement of the Evolut Pro and SAPIEN 3 resulted in tubular expansion of the surgical valve leaflets. There were significant differences in displacement angles and distances between both the J-Valve and JenaValve and the SAPIEN 3 and Evolut Pro (p < 0.0001).ConclusionsViV implantation with new-generation THVs that directly interact with bioprosthetic valve leaflets results in surgical valve leaflet retraction. This might mitigate the risk for coronary obstruction in selected cases of ViV transcatheter aortic valve replacement and also facilitate coronary reaccess after ViV TAVR.     

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.     

Local delivery of sirolimus nanoparticles for the treatment of in‐stent restenosis

Transcatheter aortic valve implantation is a possible, although off‐label, alternative to conventional aortic valve replacement for high‐surgical‐risk patients with severe, non‐calcified aortic regurgitation (AR). To date, feasibility has only been demonstrated with the Medtronic CoreValve prosthesis (MCV). This prosthesis needs the aortic sinuses to have enough width to avoid coronary obstruction. We report a case of MCV implantation for severe AR where the narrow aortic root theoretically precluded the technique. Good procedural outcome was achieved thanks to a strategy of implantation with planned positioning of the prosthesis leaflets away from the coronary arteries. © 2013 Wiley Periodicals, Inc.     

Successful transfemoral aortic Edwards® SAPIEN® bioprosthesis implantation without using iodinated contrast media in a woman with severe allergy to contrast agent

Severe anaphylactoid reaction after the use of iodinated contrast media are rare but can contraindicate the use of contrast agent. It was the case of a 53‐year‐old woman suffering from symptomatic severe aortic stenosis, recused for cardiac surgery because of deleterious effects of chest‐wall irradiation, with porcelain aorta. We decided to implant a 23‐mm Edwards^® SAPIEN^® transcatheter aortic valve via a femoral route without using any contrast media. The implantation was successful after surgical approach of the femoral artery, transesophageal echocardiography guiding, and localization of native leaflets and coronary trunk with catheters. Immediate and one month post‐interventional follow‐up was favorable and echocardiography showed a good functioning of the aortic bioprosthesis. Although conventional angiography is the best way to visualize the good positioning of the valve before deployment, our case suggests that, in special situations, transfemoral implantation of an Edwards^® SAPIEN^® aortic bioprosthesis is feasible without any contrast injection. © 2012 Wiley Periodicals, Inc.