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.     

Compassionate use of the self‐expandable medtronic corevalve prosthesis for the treatment of pure aortic regurgitation in a patient at prohibitive risk for surgical valve replacement

Transcatheter aortic valve implantation (TAVI) is a viable treatment option for high‐ and prohibitive‐risk patients with severe, calcified pure or predominant aortic valve stenosis, but not for pure aortic valve regurgitation. In fact, the use of TAVI for this indication is even considered unlikely due to the lack of calcium which appears essential for anchoring the stent‐valve and prevents dislocation. We report a case of a patient with severe, symptomatic pure aortic regurgitation, and a history of two previous open‐heart surgeries who was successfully treated by compassionate use implantation of an oversized Medtronic CoreValve prosthesis as an ultima ratio treatment option. © 2012 Wiley Periodicals, Inc.     

Transcatheter aortic valve implantation without balloon predilatation

Balloon predilatation has been regarded as an essential step before implanting the self‐expandable prosthesis during transcatheter aortic valve implantation (TAVI). Recent evidence showed that without balloon predilatation, an implantation success rate of >95% could be achieved. We report two cases in which balloon predilatation was not performed initially during TAVI but eventually required it to facilitate device crossing and implantation. They illustrated the importance of case selection and alerted us the potential limitation in performing TAVI without balloon predilatation. © 2013 Wiley Periodicals, Inc.     

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

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

Rescue “valve in valve” implantation after late onset corevalve cusp rupture leading to acute massive aortic insufficiency

Transcatheter aortic valve implantation (TAVI) has emerged as a feasible and effective alternative to aortic valve replacement in patients at high surgical risk, and is associated with a lower risk of death at 1 year follow‐up when compared with standard therapy. In a recent large study, enrolling 663 high risk patients with symptomatic severe aortic stenosis TAVI with the use of CoreValve system has been associated with early and sustained clinical and hemodynamic benefits, with a cumulative mortality of 15.0% at 1 year follow‐up. This study has shown that paravalvular aortic regurgitation after successful TAVI is a frequent finding, being of mild entity in the vast majority of cases, whereas valvular regurgitation is almost entirely absent or mild. Of note, no cases of structural valve deterioration were reported. We report a case of a successful implantation of a CoreValve that complicated with late onset massive intravalvular aortic regurgitation, due to CoreValve cusp rupture, leading to low output state with acute pulmonary edema, which was successfully treated with “valve in valve” implantation. © 2011 Wiley Periodicals, Inc.     

Transcatheter aortic valve implantation with a self-expanding nitinol bioprosthesis: prediction of the need for permanent pacemaker using simple baseline and procedural characteristics

Objective : To ascertain incidence and predictors of new permanent pacemaker (PPM) following transcatheter aortic valve implantation (TAVI) with the self‐expanding aortic bioprosthesis. Background : TAVI with the Medtronic Corevalve (MCV) Revalving System (Medtronic, Minneapolis, MN) has been associated with important post‐procedural conduction abnormalities and frequent need for PPM. Methods : Overall, 73 consecutive patients with severe symptomatic AS underwent TAVI with the MCV at two institutions; 10 patients with previous pacemaker and 3 patients with previous aortic valve replacement were excluded for this analysis. Clinical, echocardiographic, and procedural data were collected prospectively in a dedicated database. A standard 12‐lead ECG was recorded in all patients at baseline, after the procedure and predischarge. Decision to implant PPM was taken according to current guidelines. Logistic multivariable modeling was applied to identify independent predictors of PPM at discharge. Results : Patients exhibited high‐risk features as evidenced by advanced age (mean = 82.1 ± 6.2 years) and high surgical scores (logistic EuroSCORE 23.0 ± 12.8%, STS score 9.4 ± 6.9%). The incidence of new PPM was 28.3%. Interventricular septum thickness and logistic Euroscore were the baseline independent predictors of PPM. When procedural variables were included, the independent predictors of PPM were interventricular septum thickness (OR 0.52; 95% CI 0.32–0.85) and the distance between noncoronary cusp and the distal edge of the prosthesis (OR 1.37; 95% CI 1.03–1.83). Conclusions : Conduction abnormalities are frequently observed after TAVI with self‐expandable bioprosthesis and definitive pacing is required in about a third of the patients, with a clear association with depth of implant and small interventricular septum thickness. © 2011 Wiley Periodicals, Inc.     

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.     

“Device landing zone” calcification,assessed by MSCT,as a predictive factor for pacemaker implantation after TAVI

Background : After trans‐catheter aortic valve implantation (TAVI), the need for postinterventional pacemaker (PM) implantation can occur in as many as 10–50% of cases, but it is not yet clear, how this need can be predicted. The aim of this study was to assess the possible predictive factors of post TAVI PM implantation based on Computed Tomography (CT) measured aortic valve calcification and its distribution. Methods : We prospectively analyzed 81 consecutive symptomatic patients with severe AS scheduled for TAVI using the CoreValve prosthesis (Medtronic, Minneapolis, USA). In all patients, a native and contrast‐enhanced multislice cardiac CT was performed preinterventionally, estimating calcification load of the native valve cusps and of the adjacent outflow tract (so called “device landing zone”, DLZ) by the Agatston Score (AgS). Objective, computer‐evaluated, preprocedural ECG‐analysis was performed with regards to pre‐existing conduction abnormalities. Transthoracic echocardiography was performed pre and post TAVI. Results : TAVI was successful in all cases. PM implantation was deemed necessary in altogether 32 patients, out of 67 without a PM pre‐TAVI (32/67, 47%). Various parameters were tested as predictors of post TAVI PM in a multivariate logistic regression analysis model. Female sex (P = 0,005) and depressed EF (P = 0,023) showed a significant correlation. PM implantation correlated also to the DLZ calcification, as assessed by CT (P = 0,004). This model leads to an AUC (area under the ROC—receiver operator characteristics—curve) of 0.83. Conclusion : Calcium amount in the CoreValve DLZ in combination with clinical data could predict the need for post TAVI PM implantation. © 2010 Wiley‐Liss, Inc.     

First‐in‐man transcatheter aortic valve implantation of a 20‐mm edwards SAPIEN XT valve: One step forward for the treatment of patients with severe aortic stenosis and small aortic annulus

We present the case of an 85‐year‐old woman diagnosed with severe aortic stenosis, porcelain aorta, and a small aortic annulus (17.3 mm), who underwent successful transfemoral transcatheter aortic valve implantation (TAVI) with a 20‐mm Edwards SAPIEN XT valve using the NovaFlex+ delivery system. At 1‐month follow‐up the patient was in NYHA functional class I, and Doppler echocardiography showed a mean residual gradient of 15 mm Hg and trivial paravalvular aortic regurgitation. This case, which shows for the first time the feasibility of TAVI with a 20‐mm valve, opens a new avenue for the challenging treatment of patients with aortic stenosis and a small aortic annulus. © 2011 Wiley Periodicals, Inc.     

A complex ventricular septal defect following transcatheter aortic valve implantation evaluated by 3D transthoracic echocardiography

Transcatheter aortic valve implantation (TAVI) has revolutionized the treatment of elderly patients with symptomatic severe aortic valve stenosis. Among the possible TAVI complications, a rare one is the annular/left ventricular outflow tract rupture. We report a rare case of a late complex ventricular septal defect (VSD) following TAVI with a balloon‐expandable prosthesis, conservatively managed. Our case demonstrates the role of 3D transthoracic echocardiography (3DTTE) in the accurate diagnosis of this TAVI complication and suggests that, in some cases, it can be used as an alternative to other diagnostic tools, such as transesophageal echocardiography, cardiac catheterization, and computed tomography.     

Transaortic transcatheter aortic valve implantation: A novel approach for the truly “no‐access option” patients

Objectives: The aim of this study was to test the safety and efficacy of the retrograde, minimally invasive, “transaortic” approach of transcatheter aortic valve implantation (TAVI) using the Medtronic CoreValve prosthesis (Medtronic, Minneapolis) as an alternative minimally invasive surgical access route. Background: TAVI is today recognized as an established percutaneous technique for patients with severe aortic valve stenosis (AS). However, as the number of patients screened for TAVI increases, many are found with absolutely no option for peripheral artery access. Methods: A new method of TAVI access, described as “transaortic” was performed in two patients A CoreValve prosthesis was implanted via the “transaortic” route. The patients were a 93‐ and a 84‐year‐old woman, both with severe PAOD. After a ministernotomy the ascending aorta was directly punctured. At the end, the access site was surgically sutured with the prepositioned sutures. The patients were at all times “off‐pump” (beating heart procedure) and without IABP. Results: TAVI was successful in both cases, leading to a fall in the transvalvular gradient and there were no cases of mortality, stroke or myocardial infarction. The patients were extubated directly after the procedure, mobilized after 4 days, and were discharged home after 7 and 9 days. Conclusions: In the rare occasion, where due to anatomical reasons transfemoral TAVI is not feasible, a minimally invasive “transaortic” approach, as described, provides an alternative option. This is especially true when the transapical route is not suitable (annulus >25 mm or contraindication to lateral thoracotomy). © 2010 Wiley‐Liss, Inc.     

Paravalvular regurgitation one year after transcatheter aortic valve implantation

Objectives : The aim of this study was to assess the natural history of paravalvular regurgitation at 1 year in patients undergoing TAVI. Background : The immediate incidence of paravalvular regurgitation is estimated to be between 65 and 85% following transcatheter aortic valve implantation (TAVI). There is limited data as to whether this deteriorates during follow‐up. Methods : Forty‐six patients were recruited from a TAVI programme at our institute. All patients underwent an assessment of prosthetic valve function periprocedurally with aortography and immediately postprocedurally with transthoracic echocardiography. Twenty‐one patients with a median age was 83 (66–91) years of whom 14 were male reached 1 year follow‐up, 13 of whom were available for repeat transthoracic echocardiography. Results : The incidence of paravalvular regurgitation immediately following TAVI was 86%. Of them 57% had ≤ mild regurgitation and 29% had > mild regurgitation. At 1 year the incidence of paravalvular regurgitation was 77%. 54% had ≤ mild regurgitation and 34% > mild regurgitation. No patient had severe regurgitation. The degree of regurgitation reduced in 6 (46%), stayed the same in 3 (23%), and increased in 4 (31%) of patients. Conclusions : Patients undergoing TAVI have an immediate postprocedural risk of regurgitation of 86%. In the majority of cases the degree of paravalvular CoreValve® regurgitation is mild, and remains stable in 70% of patients during medium term follow‐up. © 2009 Wiley‐Liss, 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.     

Edwards Sapien 3 transcatheter aortic valve implantation for management of severe aortic regurgitation in a teenage patient with corrected atrioventricular septal defect and progressive left ventricular dysfunction

Transcatheter aortic valve replacement is mostly performed in elderly patients with severely calcified aortic valves. There are few reports about its use for pure aortic regurgitation, few reports about its use in adolescent patients and to the best of our knowledge no report about the use of an Edwards Sapien valve in the aortic position in an underage patient after surgically corrected congenital heart disease (CHD). Decompensation of a complex CHD can be difficult to manage and may require unusual solutions. We report a case of a teenage patient presenting with progressive aortic regurgitation and deterioration of left ventricular function after multiple surgical procedures for an atrioventricular septal defect (AVSD). As “bridge‐to‐transplant,” we performed a transcatheter aortic valve implantation using a balloon‐expandable Sapien 3 prosthesis. At 6 month follow‐up, the patient remained clinically stable with no rehospitalization due to heart failure.     

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.     

Difficulties with horizontal aortic root in transcatheter aortic valve implantation

Transcatheter aortic valve implantation (TAVI) emerged to be a viable treatment option for failing bioprosthesis in the aortic position. Transfemoral approach is the most common access route for TAVI and associated with most favorable clinical outcome. However, in the presence of unfavorable aortic root anatomy, TAVI via transfemoral approach provides inadequate support for device manipulation during valve positioning, particularly performed for the indication of severe aortic regurgitation. We report our experience on TAVI utilizing CoreValve for a patient with regurgitant failing bioprosthesis with horizontal aortic root where we encountered difficulties during implantation and retrieval of valve delivery system. © 2012 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.     

“Valve‐in‐valve” for the treatment of paravalvular leaks following transcatheter aortic valve implantation

Transcatheter aortic valve implantation (TAVI) is commonly associated with some degree of aortic regurgitation (AR) secondary to the presence of paravalvular leaks. We present the case of an 86‐year‐old woman diagnosed with severe aortic stenosis who underwent TAVI with a 23‐mm Edwards‐SAPIEN valve. The procedure complicated with a severe paravalvular leak following TAVI that was unresponsive to balloon postdilation. This complication was successfully managed with the implantation of a second valve of the same diameter within the first one (“valve‐in‐valve”) resulting in trivial residual AR and the absence of significant transvalvular gradient at the end of the procedure. © 2009 Wiley‐Liss, Inc.     

Management of implant failure during transcatheter aortic valve implantation

Background : Transcatheter aortic valve implantation (TAVI) is an emerging alternative to palliative medical therapy for nonsurgical patients with severe aortic stenosis. There is a paucity of detailed data on the management and outcome of complications related to the sub‐optimal deployment of the prosthesis. We appraised the incidence and management of early implant failure occurring during TAVI. Methods : Of 110 patients who underwent TAVI using the third generation 18‐French CoreValve ReValving System (Medtronic, MN) in our Institution between June 2007 and January 2010, we identified those experiencing early implant failure and reported on their management and clinical outcome. The primary endpoint was the incidence of major adverse cardiovascular and cerebrovascular event (MACCE) at 30 days and mid‐term follow up. Results : Early implant failure occurred in 18 of 110 patients (16.3%). The most common cause was prosthesis under‐expansion conditioning moderate to severe peri‐valvular leak (44.4%). Prosthesis deployment too low or too high with respect to the aortic annulus leading to severe peri‐valvular leak occurred in 22.2% and 5.5% of patients, respectively. Need of valve retrieve after the first attempt of deployment occurred in four cases (22.2%). Prosthesis embolization in the ascending aorta occurred in 5.5% of patients who experienced early implant failure. All implant failure cases were managed percutaneously with gain in aortic valve area from 0.44 ± 0.17 to 1.28 ± 0.27 cm² (P < 0.001), decrease of mean transaortic gradient from 55.00 ± 19.51 to 11.58 ± 5.91 mmHg (P < 0.001) and no MACCE at 30 days. After 11 ± 6 months, MACCE occurred cumulatively in two patients (11.1%). Conclusions : Early implant failure can complicate the TAVI procedure with the CoreValve system, but it can be managed safely and effectively with bailout transcatheter techniques, avoiding surgery, with good early and mid‐term clinical and echocardiographic results. © 2010 Wiley‐Liss, Inc.     

A word of caution using self‐expanding transcatheter aortic valve‐frame infolding

Transcatheter aortic valve replacement has become a mainstay alternative to surgical aortic valve replacement in patients with severe aortic stenosis at high and intermediate surgical risk. Two commercially approved valves are available in the United States: balloon‐expandable and self‐expanding. We report here a rare complication of a self‐expanding Evolut PRO (Medtronic, Minneapolis, Minnesota) valve failing to expand due to nitinol frame infolding. This results in a malopposed valve with a severe paravalvular leak, even though treated successfully with balloon valvuloplasty. It is important to recognize the characteristic angiographic signature of this complication—the “straight line” sign—and how to avoid this potentially serious complication by balloon valvuloplasty or by recapture and deployment of a new valve.