|Year : 2018 | Volume
| Issue : 1 | Page : 45-52
Valve-in-valve-transcatheter aortic valve replacement for surgical bioprosthetic valve failure
Vijay Kumar, Vishal Rastogi, Vivudh P Singh, Ranjan Modi, Ashok Seth
Department of Interventional Cardiology, Fortis Escorts Heart Institute, New Delhi, India
|Date of Web Publication||24-Aug-2018|
Dr. Vijay Kumar
Department of Interventional Cardiology, Fortis Escorts Heart Institute, Okhla Road, New Delhi 110025
Source of Support: None, Conflict of Interest: None
Transcatheter aortic valve replacement (TAVR) technique has an extended application for its use in replacing degenerated bioprosthetic valves implanted by open-heart surgery in the past. This procedure is especially useful for those patients who are at high risk for a redo surgery. This is called valve-in-valve-TAVR and is likely to be a standard of care for patients with bioprosthetic valve failure. This report describes valve-in-valve replacement of two such cases performed in our institute, which were at a high risk for a redo valve surgery.
Keywords: Bioprosthetic heart valve failure, transcatheter aortic valve replacement, valve in valve
|How to cite this article:|
Kumar V, Rastogi V, Singh VP, Modi R, Seth A. Valve-in-valve-transcatheter aortic valve replacement for surgical bioprosthetic valve failure. Indian Heart J Interv 2018;1:45-52
|How to cite this URL:|
Kumar V, Rastogi V, Singh VP, Modi R, Seth A. Valve-in-valve-transcatheter aortic valve replacement for surgical bioprosthetic valve failure. Indian Heart J Interv [serial online] 2018 [cited 2018 Dec 14];1:45-52. Available from: http://www.ihji.org/text.asp?2018/1/1/45/239783
| Introduction|| |
Transcatheter aortic valve replacement (TAVR) is considered as a standard therapy for all inoperable and high-surgical-risk patients with severe aortic stenosis of the native valve. Wenaweser et al., in 2007, was the first one to have used TAVR technique for implanting a new valve inside a degenerated and failed bioprosthetic heart valve at aortic position. This was the beginning of application of catheter-based valve-replacement therapy for bioprosthetic heart valve failure and has been called as “valve-in-valve-TAVR” (VinV-TAVR) therapy. Several case reports then came up. The procedure was also called as a transcatheter aortic valve in surgical aortic valve (TAV-SAV) by some implanters.,,,,,,,,,,,,,,,,,,,,,
Elective redo aortic valve surgery is associated with an increased surgical risk. The operative mortality for an elective redo aortic valve surgery in a low-risk patient is between 2% and 7%, whereas in high-risk and nonelective patients, it is more than 30%.,,,,,,,,, A redo open-heart surgery in selected patients may be stratified as a low or intermediate risk, but the associated morbidity could be high enough to be not acceptable as the first line of treatment. Blood transfusion, wound infection, postoperative pain, and delayed recovery are the other issues that increase the risk for a redo surgery in all the patients.
It has been observed in the last one decade that the use of bioprosthetic valves has increased by nearly 80% because of improvised surgical techniques and better valve durability.,These bioprosthetic valves degenerate and fail over some years and need replacement by a second open heart surgery. It has been observed that the freedom from reoperation for a failing tissue valve is close to 95%, 90%, and 70% at 5, 10, and 15 years, respectively.,,,, The lifetime risk of reoperation decreases with the increase in patient age at the time of implantation. It could be as high as 45% and 25% in those patients with a primary operation performed at 50 and 60 years of age, respectively.
The main causes of degeneration of these surgically replaced valves are wear and tear, calcification, pannus and thrombus formation, or endocarditis of the valve. It results in stenotic, regurgitant, or a mixed regurgitant and stenotic valve.
VinV-TAVR is an evolving interventional technique to replace the degenerated bioprosthesis instead of a redo surgery. Although this procedure has become well established in the western countries, it is in its initial phase of usage in India. This report describes two bioprosthetic heart valve failure cases at the aortic position, which were successfully treated with new-generation self-expanding transcatheter heart valves by “VinV-TAVR.” The patients are doing well in the follow-up period.
| Case 1|| |
The first case was that of a 78-year-old man who had his surgical bioprosthetic heart valve replacement carried out one decade back with a Hancock™ II (Medtronic, Minneapolis, MN). The patient presented with a history of progressive dyspnea over a 1-year period and was in New York heart association (NYHA) functional class IV at the time of presentation. He was having severe heart failure symptoms despite being on anti-failure decongestive therapy. Severe aortic regurgitation and stenosis of the degenerated tissue valve were observed. The society of thoracic surgery (STS) risk score was 8.7%. Imaging studies and evaluation by the heart team was carried out. Echocardiography confirmed the bioprosthetic heart valve failure. A VinV-TAVR was decided as the obvious line of treatment for this patient as an alternative to a redo surgery. Pre-TAVR workup was completed. The size, characteristics and measurements of the surgical bioprosthetic heart valve should be retrieved from the available past surgical records of the patient. Information of these would serve as an essential base line for comparison with the CT scan measurements and thus enabling the selection of valve size for implantation.
The Hancock II (21mm) valve was identified and confirmed on computerized tomography (CT) scan by its typical characteristics. The internal diameter (ID) of the Hancock II (21mm) valve as determined on CT was 17.8mm. On the basis of this value and other measurements from the CT scan, a 23-mm Evolut R (Medtronics, Inc, USA) was chosen and supra-annular placement was planned. Table shows Case 1 details, and [Figure 1], [Figure 2], [Figure 3], [Figure 4], [Figure 5], [Figure 6] show the CT images of Pre-TAVR workup and the cine images of the VinV-TAVR procedure.
|Figure 1: Computerized tomography measurements of internal diameter of prosthetic heart valve at annulus level. Compass and distance refer to the measurements made for the internal diameter of the prosthetic heart valve in relation to the annular plane (using 3mensio Medical Imaging BV Software)|
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|Figure 2: Computerized tomography measurement of sinus of Valsalva. Compass and distance refer to the measurements made for the sinus of Valsalva in relation to the annular plane (using 3mensio Medical Imaging BV Software). RCC = right coronary cusp, LCC = left coronary cusp, NCC = non coronary cusp|
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|Figure 4: Positioning the loaded Evolut R valve across the degenerated Hancock II valve so that the deployment is supra-annular|
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|Figure 6: Fully deployed Evolut R across the old Hancock II at supra-annular level|
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The patient successfully underwent his VinV-TAVR with a 23-mm self-expanding Evolut R valve. The access vessel was the right femoral artery using an 18 French sheath. The degenerated valve was crossed using an Amplatz Left-1 catheter and straight tip metal wire (260cm × 035 inch). A pre-shaped dedicated Confida wire™ (Medtronic, Inc, USA) was then exchanged through a pigtail catheter and parked safely in the left ventricle. Pre-dilation was not carried out in view of the risk of a degenerated tissue getting embolized. A plan to deploy the valve directly was decided. The landing zone for the Evolut R was just below the “eyes” of Hancock II valve aligned in one line. The device was crimped and mounted on the enVeoR (Medtronic, Inc, USA) catheter delivery system and was then railroaded over the Confida wire across the degenerated older valve. The first node of the valve was positioned in relation to the landing zone. The landing zone was aimed just below the eyes of the previous Hancock II valve in one plane, unlike the native valve situation where the predecided implantation angle and the aortic annular plane are the landmarks. When the device was getting unsheathed and deployed, temporary pacing was carried out at 170 bpm for precise deployment and prevention of any pop out of the device. The balloon-tipped pacing lead was parked in right ventricle at the beginning of the procedure as performed for all TAVR cases. The valve was successfully deployed, and the hooks were released from the catheter delivery system. The catheter delivery system was retrieved safely. Post-deployment, no aortic regurgitation and no gradient were observed across the new valve. No aortic regurgitation was confirmed by the transesophageal echocardiography (TEE), aortogram, and hemodynamics after the valve deployment. The procedure was performed under a short general anesthesia, and the patient was extubated at the end of the procedure. The access site was checked for its integrity by a contralateral shoot, and the sheath was then removed. The access port was closed by the two proglides that were pre-placed at the beginning of the procedure. The pacing lead was placed in situ for 24h, and the patient was shifted to the recovery unit by the next morning. The patient has been followed up for 1 year now. He has no para-aortic prosthesis leak and no gradient across the new valve. At present, he is in NYHA class I. The patient, who was unable to finish his breakfast without being breathless, is amazingly leading a normal life in 1 year by having a VinV-TAVR procedure.
| Case 2|| |
The second case is that of an 82-year-old frail octogenarian man who had his open-heart surgery in 2009, in which aortic valve replacement with Magna 25-mm bioprosthetic valve was carried out after root enlargement and supra-annular suturing. Coronary artery bypass surgery with left internal mammary artery (LIMA)-radial Y graft to left anterior descending (LAD) artery, the first diagonal (D1) branch, and obtuse marginal (OM) branch of the left circumflex artery was also performed along with the valve replacement. The left ventricular ejection fraction in 2009 was 55%.
He was subsequently doing fine till 2015, when progressively worsening dyspnea was noticed by the patient. He started consulting his surgeon, and a diagnosis of severe prosthetic aortic valve stenosis and regurgitation along with left ventricular dysfunction was made. Initially, during the mid-2015, his left ventricular ejection fraction was 40% with global hypokinesia, which worsened to 25% by August 2017. He was in NYHA class IV dyspnea by then. Coronary angiogram was carried out, which revealed patent grafts, and his drop in left ventricular ejection fraction was attributed to the degenerated severely leaking prosthetic heart valve. Aortic valve replacement by VinV-TAVR was advised, and he was referred to our center. The patient had a heart failure and needed stabilization by medical therapy after admission. The Magna valve had degenerated and showed significant aortic regurgitation and stenosis. The mean pressure gradient across the aortic prosthesis was 24 mmHg, and the prosthetic aortic valve area was 0.5cm2. A 2/4 central aortic regurgitation was observed. STS predicted risk of mortality was 19.6%, and the global risk for valve surgery was indeed high. Evaluation was carried out, and a VinV-TAVR using a self-expanding valve was planned by the heart team. The pre-TAVR imaging workup was restricted to transthoracic echocardiography (TTE) and TEE, and a non-contrast CT as per the institutional protocol was carried out because of stage 5 chronic kidney disease and old age.
In stented bioprosthetic surgical valves, there is an advantage and opportunity of using the fluoroscopic and plain CT-based visible images that serve as the markers for positioning and deployment of the new device. In this case, the stent frame of Magna valve served as the landmark that was sufficient for positioning and deploying the new valve without using contrast. Use of contrast was a major concern in this patient. The access route measurements and imaging were carried out by peripheral Doppler scan and non-contrast CT scan. The aortic root analysis was performed by TEE and TTE. A plain CT scan was carried out to observe the stent frame of the Magna valve, and an implantation angle was similarly predetermined. ID was measured using the fluoroscopically visible parts of the Magna valve. No contrast was thus used during pre-TAVR imaging workup. A 29-mm Evolut R valve was chosen as per the sizing chart in relation to the TEE and CT measurements of the true ID. The deployment was carried out in similar steps as the case described earlier. The stent and ring of the Magna valve served as the landmark level for the device positioning and deployment, unlike the Hancock II valve, in which the eyes of the frame were the identifying marks. The positioning of the Evolut R was carried out under fluoroscopic and cine guidance in relation to the stent of the Magna valve. No contrast was used at any stage. Intra-procedural TEE revealed no evidence of paravalvular leak or gradient across the new prosthesis. The procedure was successfully performed, and the patient was discharged on the 4th day after TAVR. He is in NYHA class II at 6 months of follow-up. No gradient across the prosthesis and no paravalvular leak were observed, and the left ventricular ejection fraction improved to 35%. The follow-up of the case has been carried out as per the valve academic research consortium II guidelines. He has been doing fine at 6-month follow-up.
The details of the case have been summarized in the table of Case 2, and the images of pre-TAVR and TAVR are shown in [Figure 7], [Figure 8], [Figure 9], [Figure 10], [Figure 11], [Figure 12].,
|Figure 8: Computerized tomography measurement of the true internal diameter of the Magna 25-mm prosthetic heart valve|
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|Figure 9: Magna valve stent being aligned such that the trans catheter heart valve would be perpendicular to the stent|
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|Figure 10: AL1 5F catheter used to cross the bioprosthetic heart valve with straight tip wire|
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| Discussion|| |
The age of both these patients with bioprosthetic valve failure is beyond the seventh decade of their lives. The STS predicted risk of mortality is very high for one patient, and the other one also has a high score. They are frail, belong to old age, and by the Indian standards have lived beyond the mean survival age of 75 years. A redo open-heart valve replacement surgery at their age is not uncommonly associated with increased morbidity and mortality. This is a major fear in the psyche of the Indian patients and their families who never like an open-heart surgery if they are aged and old. The heart team of the institution decided to perform VinV-TAVR for both the cases. The procedures were performed successfully with ease, and good outcomes were observed at a follow-up of 1 year in the first patient and 6 months in the second patient with a significant improvement in functional class and normally functioning new valves.
VinV-TAVR is a promising treatment option in case of a bioprosthetic valve failure scenario. Performing a redo heart valve replacement surgery was the only option till the availability of TAVR. Older patients with previous open-heart surgery and with comorbidities in their late life stand without doubt at high risk for a redo valve surgery. They are labeled as high risk or unfit for second surgery, nor do the patients dare to give consent for a redo open-heart surgery. The expanding application of TAVR technique to treat bioprosthetic heart valve failure is unique and gives new lease of life to these patients.
In the VIVID (Valve-In-Valve International Data) registry, approximately 40% of the bioprosthetic heart failure cases who underwent VinV-TAVR had severe prosthetic valve stenosis, 30% had predominant regurgitation, and 30% had combined regurgitation and stenosis. One month after the VinV procedure, 7.6% of the patients died, 1.7% had a major stroke, 93% of the survivors experienced good functional status (NYHA class I/II).,The overall 1-year survival rate was 83.2%. The emerging data about VinV-TAVR are not huge, but appear promising and seem to be, at least non-inferior to a redo surgery, and definitely seem to be superior for high-risk cases.
VinV-TAVR is carried out for failing bioprosthetic heart valves (both stentless and stented ones) and also for failing TAVR heart valves. VinV-TAVR for a stented valve is easier than the stentless ones because they have fluoroscopically visible elements in them, which serve as landmarks during valve deployment. The fluoroscopic appearances are different and help in identifying the valves on fluoroscopy. They could be porcine or bovine and either sutured inside or outside the stent.
Two measurements that are important in these bioprosthetic valves and are commonly referred to are the external diameter, which is the sewing ring diameter and the ID, which is the diameter of the stent frame without leaflets.,The valve size for VinV-TAVR is chosen on the basis of true ID of the previous prosthesis. Specific applications on smartphones are helpful referring links in deciding the size of the valve for failed surgical tissue valves. The intended function or position of implantation of the new valve is targeted as either supra-annular or intra-annular.
The success of a VinV-TAVR procedure for bioprosthetic heart valve failure case depends on a detailed knowledge of the design, structure, and fluoroscopic appearances of the failed surgical heart valve and correct sizing of the new valve on the basis of CT measurements of the previous valve. Knowledge about the new valves and steps of TAVR should be well known, and identification of the correct landing zone is very important. In case of stented valves, it is easier, but in stentless valves, it is difficult to identify the landing zone. Crossing the bioprosthetic valve can sometimes be tricky, which is similar to the native valve. Pre-dilation is generally avoided because of the risk of stroke from an embolized fragment of the degenerated valve tissue. Post-dilation is also avoided, unless malposition causes high gradients, or a significant paravalvular leak is observed at the end of the procedure. Both the self-expanding or balloon-expanding devices have equally good outcomes. The incidence of various procedural complications is nearly same with both valves.
Some of the more common complications with VinV-TAVR include—malpositioning, high post-valve deployment gradient, and coronary ostia occlusion. Coronary ostia pinching is more likely in VinV and is a serious complication, and it should be preempted in the pre-TAVR workup. Supra-annular positioning is advantageous in achieving better leaflet function and hemodynamics with VinV-TAVR. Higher device positioning is targeted for achieving optimal hemodynamics. Optimal implantation depths have been defined as 0–5mm for Core Valve (Medtronic Inc, Minneapolis, Minnesota) and Evolut R valves and 0–2mm (0%–10% device frame) for balloon-expanding Sapien Valve (Edwards Lifesciences Corporation, Irvine, California) in different studies. An important limitation is that the transcatheter heart valve may remain under-expanded in smaller surgical bioprostheses and result in high-residual gradients. The role of fracturing these smaller tissue valves by special balloons for better gradients after the new valve implantation is completely a new emerging concept, which is not without some risks and limitations.
It seems sensible to anticipate that the success with a VinV-TAVR strategy may lead surgeons to favor larger bioprostheses, which would be more suited to VinV strategies. The transcatheter heart valve as a first strategy also seems to be a convincing futuristic application of VinV-TAVR, when TAVR can be repeated once or twice until such time as surgical valve replacement is necessary. It will take some more time before we can fully appreciate the durability and clinical consequences of this promising new option for the patients with failing bioprosthetic valves.
| Conclusion|| |
VinV-TAVR therapy appears to be a promising, feasible, safe, and effective application of TAVR for treating bioprosthetic valve failure. It represents an appealing and minimally invasive alternative option that could become the standard of care for bioprosthetic valve failure and thus avoid the need for a redo surgery. Pre-case planning is critical to procedural success. A detailed information of the original implant should be well understood. Correct sizing is always determined on the basis of the CT scan measurements. Accurate positioning by using visible markers on fluoroscopy should be the practice. The concerns of VinV-TAVR are malposition and mechanical constraints to the new device. The issue of safety of coronaries is more serious than native valve TAVR. Coronary access and protection measures have to be taken if fear of pinching the coronary ostium exists. Long-term results of VinV-TAVR are still to be established. Fracturing the small degenerated bioprosthetic surgical valves, using specialized high pressure balloons is a new emerging concept to facilitate and optimize valve in valve implantation. The safety aspect of it requires further clinical investigation.
The challenges and unanswered questions such as the treatment of “operable” high-risk patients with failed bioprosthetic valves, durability of devices, treatment of failed small surgical valves, sizing of the devices, and last but not the least, appropriate changes in surgical valve replacement practice will also likely influence the future of VinV-TAVR for patients with bioprosthetic heart valve failure.
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Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2], [Figure 3], [Figure 4], [Figure 5], [Figure 6], [Figure 7], [Figure 8], [Figure 9], [Figure 10], [Figure 11], [Figure 12]