Valve-in-Surgical-Valve With SAPIEN 3 for Transcatheter Aortic Valve Replacement Based on Society of Thoracic Surgeons Predicted Risk of Mortality.

BACKGROUND: The use of valve-in-valve­transcatheter aortic valve replacement (VIV-TAVR) in degenerated aortic bioprosthesis has been increasing, but the Food and Drug Administration approval is limited to high-risk patients. We analyzed the real-world experience of SAPIEN 3 VIV-TAVR, especially in lower-risk patients, based on the Society of Thoracic Surgeons (STS) score. METHODS: All transfemoral VIV-TAVR with the SAPIEN 3 and Ultra valves between June 2015 and January 2020 were identified using the STS/American College of Cardiology Transcatheter Valve Therapies Registry. Patients were grouped based on STS score (low score: <4%, intermediate score: 4%≤ and≤8%, high score: >8%). Propensity-matched (1:3) analysis was conducted to compare to patients undergoing native TAVR. RESULTS: Of 145 917 SAPIEN 3 TAVR patients, 4460 (3%) underwent transfemoral VIV-TAVR with available baseline STS data in 4276 patients. Average age was 73.9±11.2, 66.4% were male, and the mean STS score was 6.9±6.0%. Overall 30-day mortality was 2.4% (observed to expected ratio, 0.33), and 1-year mortality was 10.8%. 30-day mortality and observed to expected ratio were 0.9% and 0.32 in low-score, 2.2% and 0.38 in the intermediate-score, and 4.3% and 0.31 in the high-score group. Based on propensity-matched analysis, 30-day mortality was similar and 1-year mortality was lower in VIV compared to native TAVR among all risk groups. When the groups were analyzed based on the Heart Team risk stratification using high-risk and non­high risk, the findings remained consistent. CONCLUSIONS: In this real-world study, VIV-TAVR had excellent 30-day and 1-year outcomes, especially in lower-risk patients. These findings may suggest the feasibility and expansion of VIV-TAVR in lower-risk patients. However, long-term follow-up continues to be crucial.

Open atrial transcatheter mitral valve replacement in patients with mitral annular calcification.

BACKGROUND: Mitral valve replacement in the setting of severe mitral annular calcification remains a surgical challenge. Transcatheter mitral valve replacement (TMVR) using an aortic balloon-expandable transcatheter heart valve is emerging as a potential treatment option for high surgical risk patients. Transseptal, transapical, or transatrial access is not always feasible, so an understanding of alternative implantation techniques is important. OBJECTIVES: The authors sought to present a step-by-step description of a contemporary transatrial TMVR technique using balloon-expandable aortic transcatheter heart valves. This procedure has evolved over time to address valve migration, left ventricular outflow tract obstruction, and paravalvular leak. The authors present a refined technique that has been associated with the most reproducible outcomes. METHODS: A step-by-step description of the TMVR technique and outcomes of 8 patients treated using this technique are described. Baseline patient clinical and echocardiographic characteristics and 30-day post-TMVR outcomes are presented. RESULTS: Eight patients underwent transatrial TMVR at a single institution. Five had previous cardiac surgery. Mean STS score was 8%. Technical success by MVARC (Mitral Valve Academic Research Consortium) criteria was 100%. There was zero in-hospital and 30-day mortality. Procedural success by MVARC criteria at 30 days was 100%. Paravalvular leak immediately post-implant was none or trace in 6 and mild in 1. CONCLUSIONS: The technique described is reproducible and was associated with favorable outcomes in this early experience. It represents a useful technique for the treatment of mitral valve disease in the setting of severe annular calcification. A structured and defined implantation technique is critical to investigators as this field evolves.

Open Atrial Transcatheter Mitral Valve Replacement in Patients With Mitral Annular Calcification.

BACKGROUND: Mitral valve replacement in the setting of severe mitral annular calcification remains a surgical challenge. Transcatheter mitral valve replacement (TMVR) using an aortic balloon-expandable transcatheter heart valve is emerging as a potential treatment option for high surgical risk patients. Transseptal, transapical, or transatrial access is not always feasible, so an understanding of alternative implantation techniques is important. OBJECTIVES: The authors sought to present a step-by-step description of a contemporary transatrial TMVR technique using balloon-expandable aortic transcatheter heart valves. This procedure has evolved over time to address valve migration, left ventricular outflow tract obstruction, and paravalvular leak. The authors present a refined technique that has been associated with the most reproducible outcomes. METHODS: A step-by-step description of the TMVR technique and outcomes of 8 patients treated using this technique are described. Baseline patient clinical and echocardiographic characteristics and 30-day post-TMVR outcomes are presented. RESULTS: Eight patients underwent transatrial TMVR at a single institution. Five had previous cardiac surgery. Mean STS score was 8%. Technical success by MVARC (Mitral Valve Academic Research Consortium) criteria was 100%. There was zero in-hospital and 30-day mortality. Procedural success by MVARC criteria at 30 days was 100%. Paravalvular leak immediately post-implant was none or trace in 6 and mild in 1. CONCLUSIONS: The technique described is reproducible and was associated with favorable outcomes in this early experience. It represents a useful technique for the treatment of mitral valve disease in the setting of severe annular calcification. A structured and defined implantation technique is critical to investigators as this field evolves.

1-Year Outcomes of Transcatheter Mitral Valve Replacement in Patients With Severe Mitral Annular Calcification.

BACKGROUND: The risk of surgical mitral valve replacement in patients with severe mitral annular calcification (MAC) is high. Several patients worldwide with severe MAC have been treated successfully with transcatheter mitral valve replacement (TMVR) using balloon-expandable aortic transcatheter valves. The TMVR in MAC Global Registry is a multicenter registry that collects data on outcomes of these procedures. OBJECTIVES: The goal of this study was to evaluate 1-year outcomes in this registry. METHODS: This study was a multicenter retrospective review of clinical outcomes. RESULTS: A total of 116 extreme surgical risk patients with severe MAC underwent TMVR; 106 had a procedure date >1 year before data-lock and were included in the analysis. Their mean age was 73 ± 12 years, and 68% were female. The mean Society of Thoracic Surgeons score was 15.3 ± 11.6%, and 90% were in New York Heart Association functional class III or IV. Thirty-day and 1-year all-cause mortality was 25% and 53.7%, respectively. Most patients who survived 30 days were alive at 1 year (49 of 77 [63.6%]), and the majority (71.8%) were in New York Heart Association functional class I or II. Echocardiography data at 1 year were available in 34 patients. Mean left ventricular ejection fraction was 58.6 ± 11.2%, mean mitral valve area was 1.9 ± 0.5 cm2, mean mitral gradient was 5.8 ± 2.2 mm Hg, and 75% had zero or trace mitral regurgitation. CONCLUSIONS: TMVR with balloon-expandable aortic valves in extreme surgical risk patients with severe MAC is feasible but associated with high 30-day and 1-year mortality. Most patients who survive the 30-day post-procedural period are alive at 1 year and have sustained improvement of symptoms and transcatheter valve performance. The role of TMVR in patients with MAC requires further evaluation in clinical trials.

Transcatheter Mitral Valve Replacement in Native Mitral Valve Disease With Severe Mitral Annular Calcification: Results From the First Multicenter Global Registry.

OBJECTIVES: This study sought to evaluate the outcomes of the early experience of transcatheter mitral valve replacement (TMVR) with balloon-expandable valves in patients with severe mitral annular calcification (MAC) and reports the first large series from a multicenter global registry. BACKGROUND: The risk of surgical mitral valve replacement in patients with severe MAC is high. There are isolated reports of successful TMVR with balloon-expandable valves in this patient population. METHODS: We performed a multicenter retrospective review of clinical outcomes of patients with severe MAC undergoing TMVR. RESULTS: From September 2012 to July of 2015, 64 patients in 32 centers underwent TMVR with compassionate use of balloon-expandable valves. Mean age was 73 ± 13 years, 66% were female, and mean Society of Thoracic Surgeons score was 14.4 ± 9.5%. The mean mitral gradient was 11.45 ± 4.4 mm Hg and the mean mitral area was 1.18 ± 0.5 cm(2). SAPIEN valves (Edwards Lifesciences, Irvine, California) were used in 7.8%, SAPIEN XT in 59.4%, SAPIEN 3 in 28.1%, and Inovare (Braile Biomedica, Brazil) in 4.7%. Access was transatrial in 15.6%, transapical in 43.8%, and transseptal in 40.6%. Technical success according to Mitral Valve Academic Research Consortium criteria was achieved in 46 (72%) patients, primarily limited by the need for a second valve in 11 (17.2%). Six (9.3%) had left ventricular tract obstruction with hemodynamic compromise. Mean mitral gradient post-procedure was 4 ± 2.2 mm Hg, paravalvular regurgitation was mild or absent in all. Thirty-day all-cause mortality was 29.7% (cardiovascular = 12.5% and noncardiac = 17.2%); 84% of the survivors with follow-up data available were in New York Heart Association functional class I or II at 30 days (n = 25). CONCLUSIONS: TMVR with balloon-expandable valves in patients with severe MAC is feasible but may be associated with significant adverse events. This strategy might be an alternative for selected high-risk patients with limited treatment options.

Transaortic transcatheter aortic valve implantation using the Lotus valve: first-in-man experience.

AIMS: To demonstrate the feasibility of implanting the Lotus second-generation transcatheter heart valve (THV) (designed for a transfemoral procedure) via a transaortic approach. METHODS AND RESULTS: We describe a case with severe aortic stenosis in the presence of small calibre and calcified femoral access and severe chronic obstructive pulmonary disease. The transaortic approach was the ideal approach for this patient and we successfully implanted a 25 mm Lotus valve without any complication. CONCLUSIONS: The transaortic access is a feasible and safe alternative in patients who have suboptimal iliofemoral conduits and who will benefit from the unique features of the Lotus THV.

Validation of Transesophageal Echocardiographic In Vitro Measurements for Bioprosthetic Aortic Valves: Implications for Percutaneous Valve-in-Valve Therapy.

BACKGROUND: Percutaneous valve-in-valve therapy has become an important treatment option for failing bioprosthetic heart valves. Accurate assessment of valve internal diameter (ID) is essential for effective and safe treatment. These data may not be available in an individual patient, or the manufacturer-supplied dimensions may be incorrect because they do not allow for the space occupied by valve leaflet material. METHODS: In total, 2,332 two-dimensional and three-dimensional transesophageal echocardiographic in vitro measurements were performed using both Philips iE33 and GE Vivid E9 systems with a range of system settings on 53 bioprosthetic valves in all available sizes. Two-dimensional echocardiographic ID measurements were made in two orthogonal planes at the level of the sewing ring, and similar three-dimensional measurements were generated from multiplane reconstructions. They were compared with both manufacturer-supplied valve ID (MID) and the true ID (TID) measured with Hegar dilators. RESULTS: Both the iE33 and the Vivid 9 provided comparable valve ID measurements. TID was statistically significantly smaller than MID (P < .001). All echocardiographic measurements were closer to TID than to MID. Two-dimensional measurements were closest to TID because of higher spatial resolution. CONCLUSIONS: Transesophageal echocardiographic valve ID measurements compare well with TID, which is overestimated by MID. These findings have potentially important implications for valve-in-valve procedures because an inaccurate measurement of TID might lead to the wrong choice of implanted valve.

Factors influencing left ventricular outflow tract obstruction following a mitral valve-in-valve or valve-in-ring procedure, part 1.

OBJECTIVES: To determine the factors influencing left ventricular outflow tract (LVOT) area reduction after a mitral valve-in-valve (VIV) or a valve-in-ring (VIR) procedure. BACKGROUND: Transcatheter heart valves (THVs) are increasingly used in performing a VIV or a VIR procedure in high-risk patients. Although less invasive, a potential complication is LVOT obstruction. However, the factors predisposing to LVOT obstruction are ill defined. METHODS AND RESULTS: To understand the effects of the various factors, the study was carried out in three parts: To understand the effect of VIV and VIR on reduction in LVOT area with special attention to different surgical heart valve (SHV) orientations and depth of THV implant. This was carried out in porcine and cadaver hearts. To quantify aorto-mitral-annular (AMA) angle in 20 patients with or without mitral disease and to derive a static computational model to predict LVOT obstruction. To study the effect of SHV design on LVOT obstruction after VIV. This was carried out as a bench test. LVOT area reduction was similar after VIV irrespective of orientation of the mitral SHV implantation as it pinned open the SHV leaflets. Similar effect was seen after VIR. The degree of LVOT obstruction was partly determined by AMAangle and was inversely proportional. SHV design, ring design, and depth of SPAIEN XT implantation also had effect on LVOT obstruction. CONCLUSIONS: A possibility of LVOT obstruction should be considered when performing a VIV and VIR procedure. Type of SHV, flexible ring, less obtuse AMA angle, and depth of SAPIEN XT implant can influence the risk.

Successful treatment of failing biological prosthesis because of "Stent creep" with valve-in-valve transcatheter aortic valve implantation.

INTRODUCTION: Stent creep is an uncommon mode of structural deterioration of bioprosthetic heart valves defined by a permanent inward deflection of the stent posts. This may occur because of valve over-sizing and leads to intrinsic valve stenosis. It has been described in older generation of bioprosthesis and was thought not to occur in modern devices. METHODS: We describe three patients who were referred for bioprosthetic valve degeneration with presumed aortic stenosis. Investigations demonstrated mid valvular gradient predominantly because of stent creep. We performed valve-in-valve TAVI with Edward SAPIEN prosthesis. RESULTS: Median age was 84 and logistic EuroSCORE 34.4. All patients had degenerated bioprosthesis with mean implant duration of 5.6 years. Two patients had Carpentier Edwards Perimount prosthesis (19 and 23 mm) and one patient had a Mitroflow (21 mm). Mean gradients were 33, 54, and 22 mm Hg. About 23 mm Edward SAPIEN valve was implanted in all cases with immediate improvement in haemodynamics with mean gradient reduction to 10, 17, and 8 mm Hg, respectively. The mean aortic valve area increased from 0.63 to 1.76cm(2) . There were no serious adverse events. The patients improved from NYHA III/IV to I/II post procedure and remain well at median follow-up of 24-months. DISCUSSION: Stent creep is an uncommon mode of structural deterioration in bioprosthetic heart valves. It has been described in the previous generation of bioprosthesis. It is important to distinguish leaflet dysfunction and stent creep. By forcing the stent posts outwards a balloon expandable TAVI device can be used to treat this condition.

Fluoroscopic guide to an ideal implant position for Sapien XT and CoreValve during a valve-in-valve procedure.

OBJECTIVES: This study sought to provide a guide to the fluoroscopic appearances of various valve-in-valve (VIV) combinations by deploying a transcatheter heart valve (THV) within a degenerated surgical heart valve (SHV) in an ideal position. BACKGROUND: VIV procedures are being increasingly performed with substantial experience acquired in treating degenerated SHV in the aortic position with Sapien/Sapien XT (Edwards Lifesciences Ltd., Irvine, California) and CoreValve/Evolute (Medtronic Inc., Minneapolis, Minnesota) valves. Although less invasive than conventional surgery, securing the THV in an optimal position within the SHV determines the success of this novel treatment. METHODS: For VIV implantation, we selected appropriate Sapien XT and CoreValve/Evolute sizes depending on the internal diameter of the SHV. Implantation was performed in vitro. In case of the Sapien XT valve, it was deployed 4 to 5 mm below the sewing ring of the SHV, whereas the CoreValve/Evolute was deployed 5 mm below the level of the sewing ring. Photographs and fluoroscopic images of the various VIV combinations were obtained in side profile to study the ideal position and end-on profile to study the circularity of the THV. RESULTS: Fluoroscopic images obtained in side profile highlighted the differences in various VIV combinations, as all SHV are unique in their fluoroscopic appearances. Also, all THV implants in various VIV combinations achieved a nearly circular shape. CONCLUSIONS: To achieve an optimal result when considering VIV, it is important to be familiar with the structure and fluoroscopic appearances of the failed SHV, the THV used, and their combination.

Transaortic transcatheter aortic valve implantation for failed surgical aortic valve replacement due to 'porcelain aorta'.

Transcatheter aortic valve implantation (TAVI) is an emerging surgical approach in patients with severe aortic stenosis unsuitable for conventional aortic valve replacement (AVR). TAVI has been performed through both transfemoral and transapical approaches, each with a specific suitability criterion. A transaortic (TAo-TAVI) approach has been recently established at the authors' institution for high-risk patients who are unsuited to the above techniques. Herein, the case is described of a successful aortic valve implantation using TAo-TAVI in a patient with porcelain ascending aorta that was identified as an incidental finding during conventional AVR. The patient recovered well and was discharged home without any complications.

Transcatheter aortic valve implantation for treatment of failing homograft with preexisting mechanical mitral prosthesis.

Transcatheter aortic valve implantation is increasingly used to treat bioprosthetic degeneration. Valve-in-valve technique has been performed successfully to treat homograft, stentless, and stented bioprosthetic dysfunction. The presence of a prosthesis in the mitral position can make the transcatheter aortic valve implantation procedure challenging due to proximity of the mitral and aortic annuli. We describe the case of a 66-year-old who underwent the first successful implantation of Edwards Sapien device in a failing homograft in the presence of a mechanical mitral valve prosthesis.

Transaortic Transcatheter Aortic Valve Implantation: Step-by-Step Guide.

Transcatheter aortic valve implantation (TAVI) is currently used to treat high-risk and inoperable patients with aortic stenosis. The established routes of access are retrograde transfemoral (TF) and antegrade transapical (TA). Transubclavian and transaortic (TAo) routes have been described. We have performed TAo-TAVI with the Edwards Sapien prosthesis (Edwards Lifesciences, Irvine, CA) with the Ascendra I delivery system. From 2010 we have used the Sapien XT prosthesis with the Ascendra II delivery system. In this article we describe in detail the technical aspects of performing TAo TAVI.

Transaortic transcatheter aortic valve implantation using the Edwards Sapien valve.

Transcatheter aortic valve implantation using Edwards Sapien Valve can be carried out through the ascending aorta. In the majority of patients, the ascending aorta is approached through a partial upper J-sternotomy. The sternotomy extends into the right second or third right intercostal space. The pericardium is opened in midline and the top of the ascending aorta is exposed. Two purse-string sutures are then placed on the ascending aorta and Sapien valve implantation is carried out using the Ascendra delivery system with the valve mounted in a reverse fashion to that of a transapical approach. Owing to the familiarity of the surgeons with exposing the aorta and placing purse-strings for cannulation, this procedure is within the comfort zone of surgeons compared with the transapical approach. Advantages, contra--indications, surgical technique and results are also discussed.