Transcatheter aortic valve in valve implantation with bioprosthetic valve fracture

Valve‐in‐valve transcatheter aortic valve replacement (VIV TAVR) has emerged as a preferable option for high surgical risk patients requiring redo aortic valve replacement. However, VIV TAVR may restrict flow, especially in small native aortic valves. To remedy this, bioprosthetic valve fracture has been utilized to increase the effective orifice area and improve hemodynamics. We present three cases in which bioprosthetic valve fracture was used to increase hemodynamic flow in VIV TAVR procedures.     

Transcatheter Laceration of Aortic Leaflets to Prevent Coronary Obstruction During Transcatheter Aortic Valve Replacement: Concept to First-in-Human

Objectives

This study sought to develop a novel technique called bioprosthetic or native aortic scallop intentional laceration to prevent coronary artery obstruction (BASILICA).

The BASILICA Trial: Prospective Multicenter Investigation of Intentional Leaflet Laceration to Prevent TAVR Coronary Obstruction

ObjectivesThe BASILICA (Bioprosthetic or native Aortic Scallop Intentional Laceration to prevent Iatrogenic Coronary Artery obstruction during TAVR) investigational device exemption trial was a prospective, multicenter, single-arm safety and feasibility study.BackgroundCoronary artery obstruction is a rare but devastating complication of transcatheter aortic valve replacement (TAVR). Current stent-based preventative strategies are suboptimal. Bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction during TAVR (BASILICA) is a novel transcatheter technique performed immediately before TAVR to prevent coronary artery obstruction.MethodsSubjects with severe native or bioprosthetic aortic valve disease at high or extreme risk for surgery, and at high risk of coronary artery obstruction, were included. The primary success endpoint was successful BASILICA and TAVR without coronary obstruction or reintervention. The primary safety endpoint was freedom from major adverse cardiovascular events. Data were independently monitored. Endpoints were independently adjudicated. A core laboratory analyzed computed tomography images.ResultsBetween February 2018 and July 2018, 30 subjects were enrolled. Primary success was met in 28 (93%) subjects. BASILICA traversal and laceration was successful in 35 of 37 (95%) attempted leaflets. There was 100% freedom from coronary obstruction and reintervention. Primary safety was met in 21 (70%), driven by 6 (20%) major vascular complications related to TAVR but not BASILICA. There was 1 death at 30 days. There was 1 (3%) disabling stroke and 2 (7%) nondisabling strokes. Transient hemodynamic compromise was rare (7%) and resolved promptly with TAVR.ConclusionsBASILICA was feasible in both native and bioprosthetic valves. Hemodynamic compromise was uncommon. Safety was acceptable and needs confirmation in larger studies. BASILICA appears effective in preventing coronary artery obstruction from TAVR in subjects at high risk.     

Balloon valuloplasty prior to transcatheter valve‐in‐valve implantation in a degenerated mitroflow aortic bioprosthesis

Transcatheter valve‐in‐valve implantation is an emerging treatment option for high‐risk patients with failing aortic bioprostheses. The presence of the prosthesis stents is thought to prevent coronary artery obstruction, a known complication of transcatheter aortic valve implantation in the native aortic valve. The Sorin Mitroflow aortic bioprosthesis (Sorin Group, Saluggia, Italy) has a particular design in that the pericardial leaflets are mounted outside the valve stent. As a consequence, the pericardial leaflets of this prosthesis may be displaced well away from the stents during the deployment of transcatheter valves. This might explain why both the cases of coronary occlusion following valve‐in‐valve implantation reported to date occurred in patients with a malfunctioning Mitroflow bioprosthesis. We describe a patient with a malfunctioning 25 mm Mitroflow bioprosthesis successfully treated by percutaneous transcatheter valve‐in‐valve implantation, and discuss the role that balloon aortic valvuloplasty plays in the performance of this delicate procedure. © 2012 Wiley Periodicals, Inc.     

Preventing Coronary Obstruction During Transcatheter Aortic Valve Replacement: From Computed Tomography to BASILICA

Coronary artery obstruction is an uncommon but devastating complication of transcatheter aortic valve replacement (TAVR). Computed tomography appears to be a sensitive but nonspecific predictor of coronary artery obstruction. Transcatheter approaches to prevent and treat coronary artery obstruction, such as “snorkel” stenting, are unsatisfactory because of serious early and late ischemic complications. Bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction during TAVR (BASILICA) is an early-stage transcatheter procedure to prevent coronary artery obstruction. It works by splitting the native or bioprosthetic leaflets so that they splay after TAVR and preserve coronary artery inflow. Because of the paucity of suitable alternatives, there is interest in the BASILICA technique despite its infancy. This tutorial review summarizes current thinking about how to predict and prevent coronary artery obstruction using BASILICA. First, the authors depict the main pathophysiological mechanisms of TAVR-associated coronary artery obstruction, along with the factors thought to contribute to coronary obstruction. Next, the authors provide a step-by-step guide to analyzing pre-procedural computed tomographic findings to assess obstruction risk and, if desirable, to plan BASILICA. Next, the authors describe the mechanisms underlying transcatheter electrosurgery. Finally, they provide step-by-step guidance on how to perform the procedure, along with a required equipment list.     

Reversible thrombotic aortic valve restenosis after valve‐in‐valve transcatheter aortic valve replacement

Thrombotic aortic valve restenosis following transcatheter aortic valve replacement (TAVR) has not been extensively reported and the rates of TAVR valve thrombosis are not known. We present three cases of valve‐in‐valve (VIV) restenosis following TAVR with the balloon expandable transcatheter heart valves, presumably due to valve thrombosis that improved with anticoagulation. © 2016 Wiley Periodicals, Inc.     

Procedural and clinical outcomes of the valve‐in‐valve technique for severe aortic insufficiency after balloon‐expandable transcatheter aortic valve replacement

Objective : To describe the clinical and procedural outcomes of patients treated with the valve‐in‐valve technique for severe aortic insufficiency (AI) after balloon‐expandable transcatheter aortic valve replacement (TAVR). Background : Severe AI immediately after valve implantation is a notable complication of TAVR. It can be treated with a valve‐in‐valve technique which involves deploying a second valve within the first one to crush the leaflets of the first implant leaving a new functional valve. Methods : We analyzed data on 142 consecutive patients at our institution undergoing TAVR with the Sapien valve between November of 2007 and April of 2011. Etiologies of acute AI, procedural and intermediate term clinical outcomes were reported for those in whom a valve‐in‐valve procedure was necessary. Post‐hoc analysis of these cases with C‐THV imaging (Paieon Medical Ltd.) was performed to elucidate the mechanism for successful AI treatment. Results : A total of 5 of 142 (3.5%) patients were treated with the valve‐in‐valve technique. Etiologies of the aortic valve insufficiency included bioprosthesis malposition (n = 3), valve dysfunction (n = 1), and valve undersizing (n = 1). With placement of the second valve, the first valve dimensions increased to approach the nominal valve size while the second valve size remained less than nominal. Conclusions : The valve‐in‐valve technique is an appropriate bailout measure for patients with acute valvular AI after balloon‐expandable TAVR. © 2012 Wiley Periodicals Inc.     

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.     

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.     

Valve‐in‐valve transcatheter aortic valve replacement to treat multijet paravalvular regurgitation: A case series and review

Treatment advances for severe symptomatic aortic stenosis including transcatheter and open surgical valve replacement have improved patient survival, length of stay, and speed to recovery. However, paravalvular regurgitation (PVR) is occasionally seen and when moderate or greater in severity is associated with an at least 2‐fold increase in 1 year mortality. While several treatment approaches focused on single‐jet PVR have been described in the literature, few reports describe multijet PVR. Multijet PVR can successfully be treated with a variety of catheter‐based options including valve‐in‐valve (ViV) transcatheter aortic valve replacement (TAVR). We present two patients with at least moderate PVR following aortic valve replacement who were successfully treated with ViV TAVR along with a review of literature highlighting our rationale for utilizing each management approach. Multijet PVR can be treated successfully with ViV TAVR, but additional options such as self‐expanding occluder devices and bioprosthetic valve fracture have a role as adjunctive treatments to achieve optimal results. The etiology of multijet PVR can differ between patients, this heterogeneity underscores the paucity of data to guide treatment strategies. Therefore, successful treatment of multijet PVR requires familiarity with available therapeutic options to achieve optimal results and, by extension, decrease patient mortality.     

CoreValve bioprosthesis dysfunction treated with a Sapien 3 valve-in-valve transcatheter aortic valve replacement and BASILICA technique

Structural deterioration of transcatheter heart valve (THV) has been previously described. With the expansion of transcatheter aortic valve replacement (TAVR) indications toward treating lower risk patients with longer life expectancy, there will be increased necessity of managing the patients with THV dysfunction including those at risk for coronary obstruction or sinus sequestration. Coronary access also remains a challenge in such cases with THV dysfunction undergoing valve-in-transcatheter heart valve (ViTHV) TAVR. A unique and first reported case of THV deterioration treated with Sapien 3 ViTHV-TAVR inside a 31 mm CoreValve bioprosthesis along with left coronary leaflet laceration using the BASILICA technique has been presented.     

Transcatheter aortic valve replacement: The year in review 2016

Transcatheter aortic valve replacement (TAVR) continued to make major strides in 2016, simultaneously expanding its application to lower risk patients as well as more technically challenging subsets of patients with aortic stenosis (AS). The two major accomplishments this year were the establishment of TAVR as the preferred treatment strategy over surgical aortic valve replacement (SAVR) in intermediate risk patients, and initial signals that TAVR and SAVR may be clinically equivalent in low‐risk populations. Meanwhile, there is continued expansion of TAVR to challenging clinical subsets (bicuspid aortic valve [BAV], patients with concomitant advanced coronary artery disease [CAD], and failed surgical bioprostheses), and encouraging initial experiences with newer transcatheter heart valve systems. This paper summarizes the major research studies published on TAVR in 2016.

     

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.     

Preventing Coronary Obstruction During Transcatheter Aortic Valve Replacement: Results From the Multicenter International BASILICA Registry

ObjectivesThis study sought to determine the safety of the BASILICA (bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction) procedure.BackgroundTranscatheter aortic valve replacement causes coronary artery obstruction in 0.7% of cases, with 40% to 50% mortality. BASILICA is a procedure to prevent coronary obstruction. Safety and feasibility in a large patient cohort is lacking.MethodsThe international BASILICA registry was a retrospective, multicenter, real-world registry of patients at risk of coronary artery obstruction undergoing BASILICA and transcatheter aortic valve replacement. Valve Academic Research Consortium-2 definitions were used to adjudicate events.ResultsBetween June 2017 and December 2020, 214 patients were included from 25 centers in North America and Europe; 72.8% had bioprosthetic aortic valves and 78.5% underwent solo BASILICA. Leaflet traversal was successful in 94.9% and leaflet laceration in 94.4%. Partial or complete coronary artery obstruction was seen in 4.7%. Procedure success, defined as successful BASILICA traversal and laceration without mortality, coronary obstruction, or emergency intervention, was achieved in 86.9%. Thirty-day mortality was 2.8% and stroke was 2.8%, with 0.5% disabling stroke. Thirty-day death and disabling stroke were seen in 3.4%. Valve Academic Research Consortium-2 composite safety was achieved in 82.8%. One-year survival was 83.9%. Outcomes were similar between solo and doppio BASILICA, between native and bioprosthetic valves, and with the use of cerebral embolic protection.ConclusionsBASILICA is safe, with low reported rates of stroke and death. BASILICA is feasible in the real-world setting, with a high procedure success rate and low rates of coronary artery obstruction.     

Echocardiographic follow‐up after transcatheter aortic valve replacement

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

Urgent transcatheter aortic valve replacement for severe acute aortic regurgitation following open mitral valve surgery

Transcatheter aortic valve replacement (TAVR) is not currently approved for pure native valve aortic incompetence, and is typically performed on a compassionate basis in selected patients who are at high risk for conventional surgery. We describe the first use of TAVR to treat iatrogenic severe acute pure aortic incompetence following mitral valve surgery. A 71‐year‐old gentleman developed life‐threatening acute aortic regurgitation (AR) within hours of a very challenging fifth open heart mitral valve replacement. Careful inspection of echocardiographic and computed tomographic imaging identified the cause as a disrupted left coronary cusp at the commissure caused by the surgical mitral annular reconstruction. Medical management with afterload reduction failed with recurrent pulmonary edema, and a sixth open heart surgery was deemed prohibitively high risk. The lack of aortic annular calcium onto which anchors a transcatheter valve was a concern for TAVR. However, we postulated that the struts of the mitral valve bioprosthesis would offer some support to the TAVR valve. We opted for a self‐expanding system because of concerns about potential unfavorable interaction between the balloon onto which balloon‐expandable bioprosthesis is mounted and the struts of the mitral bioprosthesis, and because the Evolut R system has additional anchoring points at the crown which might enhance transcatheter valve stability in the non‐calcified annulus, compared with the Edwards Sapien system. Transfemoral TAVR, performed with a Medtronic Evolut R 34 mm system under general anesthesia and using moderately rapid ventricular pacing, was successful with minimal residual AR. On follow‐up 1 month later the patient was asymptomatic, and the aortic and mitral bioprostheses were functioning normally on echocardiogram.     

First-in-Human Dedicated Leaflet Splitting Device for Prevention of Coronary Obstruction in Transcatheter Aortic Valve Replacement

BackgroundCoronary artery obstruction is a life-threatening complication of transcatheter aortic valve replacement (TAVR) procedures. Current preventive strategies are suboptimal.ObjectivesThe aim of this study was to describe bench testing and clinical experience with a novel device that splits valve leaflets that are at risk for causing coronary obstruction after TAVR, allowing normal coronary flow.MethodsThe ShortCut device was initially tested in vitro and preclinically in a porcine model for functionality and safety. The device was subsequently offered to patients at elevated risk for coronary obstruction. Risk for coronary obstruction was based on computed tomography–based anatomical characteristics. Procedure success was determined as patient survival at 30 days with a functioning new valve, without stroke or coronary obstruction.ResultsFollowing a successful completion of bench testing and preclinical trial, the device was used in 8 patients with failed bioprosthetic valves (median age 81 years; IQR: 72-85 years; 37.5% man) at 2 medical centers. A total of 11 leaflets were split: 5 patients (63.5%) were considered at risk for left main obstruction alone, and 3 patients (37.5%) were at risk for double coronary obstruction. All patients underwent successful TAVR without evidence of coronary obstruction. All patients were discharged from the hospital in good clinical condition, and no adverse neurologic events were noted. Procedure success was 100%.ConclusionsEvaluation of the first dedicated transcatheter leaflet-splitting device shows that the device can successfully split degenerated bioprosthetic valve leaflets. The procedure was safe and successfully prevented coronary obstruction in patients at risk for this complication following TAVR.     

Risk Assessment of Coronary Obstruction During Transcatheter Aortic Valve Replacement: Insights From Post-BASILICA Computed Tomography

ObjectivesThe aim of this study was to examine the predictive value of preprocedural computed tomography (CT)–based risk stratification of coronary obstruction during transcatheter aortic valve replacement (TAVR) on the basis of geometric measurements on postprocedural CT.BackgroundProper patient selection for additional procedures to prevent coronary obstruction during TAVR has not been adequately evaluated.MethodsPre- and postprocedural computed tomographic scans of 28 patients treated using bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction (BASILICA) and TAVR were analyzed. Using the postprocedural computed tomographic images, threatened coronary obstruction (TCO) was defined as: 1) ostial obstruction (adherence of the transcatheter heart valve [THV] to the coronary ostium with leaflet extension above the ostium); and/or 2) sinus sequestration (THV adherence to the sinotubular junction [STJ] with leaflet extension above the STJ) and was substratified into complete and incomplete types.ResultsA total of 51 leaflets were evaluated (88% surgical tissue valves) after excluding leaflets not visible on CT (n = 5). On postprocedural CT, complete TCO was observed in 25.4% (13 of 51 leaflets). On preprocedural CT, leaflets were at high risk for complete TCO (incidence 53%) if the virtual THV–to–coronary distance (VTC) was <3.0 mm, or if the virtual THV–to–STJ distance (VTSTJ) was <1.0 mm with STJ height ? leaflet length <0 mm (leaflet-STJ mismatch). Leaflets were at low risk (incidence 0%) if the VTC was ≥3 mm and VTSTJ was ≥3.0 mm or STJ height ? leaflet length was ≥+2.0 mm. Of 28 leaflets treated using BASILICA, complete TCO was seen in 35.7% (n = 10), due to sinus sequestration (100%) with coexisting ostial obstruction (30%). Actual coronary events occurred in 7.1% (n = 2) because of leaflet prolapse, corresponding to an absolute risk reduction by BASILICA of 29% (P = 0.021).ConclusionsRisk assessment of coronary obstruction after TAVR may improve with a multiparametric approach incorporating VTC, VTSTJ, and leaflet-STJ mismatch. BASILICA appeared to reduce actual coronary events even in leaflets with anticipated coronary obstruction.     

The first case of “locked‐in leaflet” after transcatheter aortic valve replacement in a patient with bicuspid aortic stenosis

This case report is about an 85‐year‐old woman with bicuspid aortic stenosis (AS). Although preoperative multimodality imaging showed challenging anatomical aspects, transcatheter aortic valve replacement (TAVR) was selected to be performed as a less invasive alternative treatment approach, owing to her comorbidity. Postoperative transesophageal echocardiography and multidetector‐row computed tomography revealed the presence of “locked‐in leaflet” caused by stent distortion due to pinching by calcified native leaflets, with nodular calcification preventing the full expansion of the valve, which resulted in moderate perivalvular leakage. This is the first reported case of bicuspid AS treated with TAVR that eventually resulted in “locked‐in leaflet.”     

Endovascular iliac rescue technique for complete arterial avulsion after transcatheter aortic valve replacement

Transcatheter aortic valve replacement (TAVR) has emerged as an alternative therapy to open aortic valve repair for high‐risk patients with aortic stenosis, but larger delivery sheath size is associated with vascular complications. We report 2 cases in which a minimally invasive technique was used for the hybrid repair of confirmed or suspected large‐bore sheath traumatic avulsion (i.e., “iliac on a stick”) after TAVR. We believe our hybrid approach to rescuing the iliac artery in suspected or confirmed complete artery avulsion could improve outcomes for patients who require TAVR. © 2013 Wiley Periodicals, Inc.