Self-expanding Device Research Articles

Comparison of the self-expanding CoreValve device and the mechanically expanding Lotus transcatheter aortic valve prosthesis

Comparison of the self-expanding CoreValve device and the mechanically expanding Lotus transcatheter aortic valve prosthesis

Abstract 13349: Long Term (4 Years) Clinical and Echocardiographic Results of Transcatheter Self-expanding Medtronic Corevalve Device in Patients With Aortic Stenosis

Introduction: Transcatheter aortic valve implantation (TAVI) has emerged as an alternative to surgical aortic valve replacement for patients (pts) with severe aortic stenosis considered inoperable or at high operative risk. However, little is known about long-term outcomes following TAVI. In this study we assessed the 4-year clinical and echocardiographic outcomes of pts undergoing TAVI with the self expanding Medtronic CoreValve prosthesis. Methods: The 4-year outcomes following successful TAVI with the self-expanding aortic valve device (Medtronic CoreValve) were evaluated in 60 pts (mean age 79+6 years, male 47 %, Logistic Euroscore 28.43+10.93%). Principal outcome measures were death from any cause. An echocardiograpic examination was performed at prespecified intervals of 6 and 12 months, and every year afterwards. Categorical variables were compared using X2 test, and continuous variables using t test. Survival curves were also constructed. Results: All cause mortality at 1, 2, 3, and 4 years was 16.7%, 28.3%, 30%, and 40% respectively. Mean aortic valve gradient decreased from 50.96+18.6 mm Hg pre to 9.22+ 4.6 mm Hg after TAVI (P<0.001) and remained at 15.69+6.3 mm Hg at 4 years (p for post-TAVI trend <0.01). Mean aortic valve area increased from 0.66+ 0.14 cm2 pre to 1.87+0.33 cm2 after TAVI (p<0.001) and remained at 1.23+ 0.25 cm2 at 4 years (p for post-TAVI trend <0.01). Paravalvular leak (minimal to moderate) was observed in 61% of pts post-TAVI; however, there was no case of progression to severe regurgitation at 4 years follow-up. Conclusions: TAVI with the Medtronic CoreValve prosthesis is associated with sustained clinical and functional cardiovascular benefits in inoperable or high-risk patients with symptomatic aortic stenosis up to 4-year follow-up.

Valve implantations on the move.

Valve implantations on the move.

TCT-705 Trascatheter Aortic Valve Implantation Outcomes With Self-Expandable and Balloon-Expandable Devices in Patients with Mixed Aortic Valve Stenosis

Prevalence of mixed aortic stenosis (MAS) in patients undergoing TAVI is unclear. Due to the particular pathophysiology of this condition, these patients could represent a high-risk group with regards to device malpositioning, post-procedural aortic regurgitation (PPAR) and other complications. To

Transcatheter mitral valve implantation (TMVI) using the Edwards FORTIS device.

Transcatheter aortic valve implantation (TAVI) has demonstrated the feasibility of treating valvular heart disease with transcatheter therapy. On the back of this success, various transcatheter concepts are being evaluated to treat other valvular disease, especially mitral regurgitation (MR). The concepts currently approved to treat MR replicate surgical mitral valve repair. However, most of them cannot eliminate MR completely. Similar to TAVI, a transcatheter mitral valve implantation may provide a valuable alternative. The FORTIS transcatheter mitral valve (Edwards Lifesciences, Irvine, CA, USA) is a self-expanding device implanted via a transapical approach. We describe our experience and early results in the first five patients treated on compassionate grounds. We also describe the details of the device, selection criteria and technical details of implantation.

Transapical transcatheter aortic valve for severe aortic regurgitation: expanding the limits.

This study sought to evaluate the self-expandable ACURATE TA device (Symetis SA, Ecublens, Switzerland) in a cohort of patients with pure aortic regurgitation (AR). Transcatheter aortic valve replacement (TAVR) has been initially considered as an alternative for high-risk patients with aortic stenosis. Although the current experience is limited, TAVR might be also an alternative to treat patients with pure, severe AR. Between April 2012 and December 2013, a total of 8 high-risk patients with pure, severe AR were enrolled (grade III+). Clinical and hemodynamic data as well as data on device and procedure parameters and outcomes were collected. Patient mean was 72.5 ± 8.4 years, and 37.5% of patients were female. Logistic EuroSCORE was 34.0 ± 7.9% and the Society of Thoracic Surgeons score was 7.3 ± 3.3% on average. Two patients had undergone emergency aortic operation before due to acute type A aortic dissection, and both were treated by replacement of the ascending aorta (including root reconstruction) and the aortic arch combined with or without E-vita Open stent graft (Jotec GmbH, Hechingen, Germany) (January 2011 and March 2012), whereas the other patients experienced primary AR. All patients underwent successful transapical TAVR with the transapical ACURATE TA device (size small, n= 1, size medium, n= 3, size large, n= 4) without any intraprocedural complications according to the Valve Academic Research Consortium 2criteria. Post-procedure AR grade I+ or lower, as revealed by transoesophageal echocardiography and angiography, waspresent in all 8 patients. At 30 days, the stroke incidence and all-cause mortality rate were 0%. This small single-center series demonstrates the feasibility of transapical TAVR with the self-expandable ACURATE TA device in high-risk patients with severe AR.

Device-dependent association between paravalvar aortic regurgitation and outcome after TAVI

ObjectiveThe aim of the current study was to identify predictors of paraprosthetic aortic regurgitation (AR) after transcatheter aortic valve implantation (TAVI) and examine its influence on short/medium-term mortality using the...

O-036 Treatment of Intracranial Aneurysms with the LUNA AES: Midterm Clinical and Angiographic Follow-Up

PurposeThe LUNA is a self-expanding ovoid device that serves as an intra saccular flow diverter as well as a scaffold for endothelization across the neck. The objective of this prospective...

The Odyssey of TAVR from concept to clinical reality.

On 16 April 2002, my colleagues and I performed, in an inoperable and desperately ill man with critical calcific aortic stenosis (AS), the first clinical percutaneous implantation of an aortic valve bioprosthesis. As of 2013, more than 80,000 patients have been treated; and transcatheter aortic valve replacement (TAVR), so strongly criticized by all the experts throughout the early years, continues to grow in parallel with its constant technological improvements. Transcatheter aortic valve replacement can now be recognized as a medical breakthrough. It is a revolutionary technology that meets an unfulfilled clinical need for a common disease, is validated by rigorous evidence-based studies, and is applicable worldwide. We report here the main phases of this 20-year odyssey and briefly consider the prospects of TAVR, which remains in continuous development.

Postprocedural Aortic Regurgitation in Balloon-Expandable and Self-Expandable Transcatheter Aortic Valve Replacement Procedures

Background— Significant postprocedural aortic regurgitation (AR) is observed in 10% to 20% of cases after transcatheter aortic valve replacement (TAVR). The prognostic value and the predictors of such a complication in balloon-expandable (BE) and self-expandable (SE) TAVR remain unclear. Methods and Results— TAVR was performed in 3195 consecutive patients at 34 hospitals. Postprocedural transthoracic echocardiography was performed in 2769 (92%) patients of the eligible population, and these patients constituted the study group. Median follow-up was 306 days (Q1–Q3=178–490). BE and SE devices were implanted in 67.6% (n=1872) and 32.4% (n=897). Delivery was femoral (75.3%) or nonfemoral (24.7%). A postprocedural AR≥grade 2 was observed in 15.8% and was more frequent in SE (21.5%) than in BE-TAVR (13.0%, P =0.0001). Extensive multivariable analysis confirmed that the use of a SE device was one of the most powerful independent predictors of postprocedural AR≥grade 2. For BE-TAVR, 8 independent predictors of postprocedural AR≥grade 2 were identified including femoral delivery ( P =0.04), larger aortic annulus ( P =0.0004), and smaller prosthesis diameter ( P =0.0001). For SE-TAVR, 2 independent predictors were identified including femoral delivery( P =0.0001). Aortic annulus and prosthesis diameter were not predictors of postprocedural AR for SE-TAVR. A postprocedural AR≥grade 2, but not a postprocedural AR=grade 1, was a strong independent predictor of 1-year mortality for BE (hazard ratio=2.50; P =0.0001) and SE-TAVR (hazard ratio=2.11; P =0.0001). Although postprocedural AR≥grade 2 was well tolerated in patients with AR≥grade 2 at baseline (1-year mortality=7%), it was associated with a very high mortality in other subgroups: renal failure (43%), AR<grade 2 at baseline (31%), low transaortic gradient (35%), or nonfemoral delivery (45%). Conclusions— Postprocedural AR≥grade 2 was observed in 15.8% of successful TAVR and was the strongest independent predictor of 1-year mortality. The use of the SE device was a powerful independent predictor of postprocedural AR≥grade 2.

Device Interventions for Stroke Prevention in Atrial Fibrillation

Atrial fibrillation (AF) is the most common sustained heart rhythm disorder, with an estimated prevalence of 0.4% to 1% in the general population. In addition, AF is responsible for approximately 15% to 20% of ischemic strokes. Device interventions to prevent strokes in patients with AF are nonsurgical procedures to block blood clots (thrombus) from forming and traveling out of the heart. The “quivering” rather than normal contractions of the upper chambers of the heart (atria) from disorganized electric activity (AF) leads to blood stasis and thrombus formation. A small cul-de-sac called the left atrial appendage (LAA) is especially prone to thrombus formation (Figure 1). In AF patients without valvular heart disease, almost all thrombus originates from the LAA. The thrombus travels to and block major vessels in the body. Blocking blood vessels to the brain leads to strokes and transient ischemic attacks (mini-strokes). Figure 1. Transesophageal echocardiogram image of a thrombus in the left atrial appendage (dotted line). Patients with the following risk factors have a higher stroke risk: heart failure, hypertension, age of 75 years or greater, diabetes mellitus, and prior history of strokes or mini-strokes. These are often combined to form the CHADS2 score. The more risk factors you have, the higher your CHADS2 score and risk of stroke are. Blood-thinning medications (anticoagulants) such as warfarin, dabigatran, rivaroxaban, and apixaban are effective stroke prevention therapies. The risks of bleeding associated with long-term anticoagulation led to the development of permanent treatment options like surgery. Closures by sutures (ligation) and removal (amputation) of the LAA …

Percutaneous Occlusion of Acquired Aorto-Coronary Venous Fistula After Coronary Artery Bypass Graft Surgery: Initial Experience Using the Self-Expandable Nitinol Vascular Plug

Inadequate anastomosis of aorto-coronary grafts to the coronary venous system represents an infrequent but potentially serious complication of coronary artery bypass surgery. Different surgical techniques and percutaneous devices have been described for the permanent correction of these fistulas. We report two cases of iatrogenic aorto-coronary fistulas successfully treated with percutaneous occlusion using the self-expandable nitinol device (vascular plug). Oclusão Percutânea de Fístula Aorto-Coronária Venosa Adquirida Após Revascularização Miocárdica: Experiência Inicial com Plug Vascular Autoexpansível de Nitinol Enxertos aorto-coronários anastomosados inapropriadamente no sistema venoso representam complicação infrequente, porém potencialmente grave, das cirurgias de revascularização miocárdica. Técnicas cirúrgicas e dispositivos percutâneos diversos têm sido descritos para a correção definitiva dessas fístulas. Relatamos aqui dois casos de fístulas aorto-coronárias iatrogênicas submetidas à oclusão percutânea com sucesso, utilizando-se dispositivo autoexpansível de nitinol (plug vascular).

Oclusão Percutânea de Fístula Aorto-Coronária Venosa Adquirida Após Revascularização Miocárdica: Experiência Inicial com Plug Vascular Autoexpansível de Nitinol

Inadequate anastomosis of aorto-coronary grafts to the coronary venous system represent an infrequent but potentially serious complication of coronary artery bypass surgery. Different surgical techniques and percutaneous devices have been described for the permanent correction of these fistulas. We report two cases of iatrogenic aorto-coronary fistulas successfully treated with percutaneous occlusion using the self-expandable nitinol device (vascular plug).

Abstract No. 335 - Initial clinical experience with a novel microcatheter-deliverable vascular plug

PurposeTo discuss and evaluate the efficacy of the MVP™ Micro Vascular Plug system, a self-expanding vessel occlusion device, in peripheral and neurovascular applications.Materials and MethodsA retrospective review was conducted of six cases from August to September 2013, two cases of neurotrauma and four cases of hepatic arterial mapping prior to Y90 radioembolization. All six cases utilized the MVP-3 Micro Vascular Plug system for embolization, a self-expanding occlusion device comprised of nitinol and a partial PTFE cover intended for vessels ranging from 1.5 to 3.0 mm in diameter deliverable through a 0.021 inch inner diameter microcatheter.ResultsPrompt and complete occlusion of the target vessels was observed in all six cases without a necessity for a secondary embolization agent. Target vessels included vertebral, lingual, segmental hepatic, gastroduodenal, and supraduodenal arteries. Two vascular plugs were required in one of the neurointerventions given the complexity of the traumatic injury. No significant migration of the plugs was observed.ConclusionThe MVP™ Micro Vascular Plug system, currently available in the United States in a 3-mm system and deliverable through a 0.021 inch microcatheter, was effective in prompt occlusion of target vessels in both peripheral and neurovascular applications. PurposeTo discuss and evaluate the efficacy of the MVP™ Micro Vascular Plug system, a self-expanding vessel occlusion device, in peripheral and neurovascular applications. To discuss and evaluate the efficacy of the MVP™ Micro Vascular Plug system, a self-expanding vessel occlusion device, in peripheral and neurovascular applications. Materials and MethodsA retrospective review was conducted of six cases from August to September 2013, two cases of neurotrauma and four cases of hepatic arterial mapping prior to Y90 radioembolization. All six cases utilized the MVP-3 Micro Vascular Plug system for embolization, a self-expanding occlusion device comprised of nitinol and a partial PTFE cover intended for vessels ranging from 1.5 to 3.0 mm in diameter deliverable through a 0.021 inch inner diameter microcatheter. A retrospective review was conducted of six cases from August to September 2013, two cases of neurotrauma and four cases of hepatic arterial mapping prior to Y90 radioembolization. All six cases utilized the MVP-3 Micro Vascular Plug system for embolization, a self-expanding occlusion device comprised of nitinol and a partial PTFE cover intended for vessels ranging from 1.5 to 3.0 mm in diameter deliverable through a 0.021 inch inner diameter microcatheter. ResultsPrompt and complete occlusion of the target vessels was observed in all six cases without a necessity for a secondary embolization agent. Target vessels included vertebral, lingual, segmental hepatic, gastroduodenal, and supraduodenal arteries. Two vascular plugs were required in one of the neurointerventions given the complexity of the traumatic injury. No significant migration of the plugs was observed. Prompt and complete occlusion of the target vessels was observed in all six cases without a necessity for a secondary embolization agent. Target vessels included vertebral, lingual, segmental hepatic, gastroduodenal, and supraduodenal arteries. Two vascular plugs were required in one of the neurointerventions given the complexity of the traumatic injury. No significant migration of the plugs was observed. ConclusionThe MVP™ Micro Vascular Plug system, currently available in the United States in a 3-mm system and deliverable through a 0.021 inch microcatheter, was effective in prompt occlusion of target vessels in both peripheral and neurovascular applications. The MVP™ Micro Vascular Plug system, currently available in the United States in a 3-mm system and deliverable through a 0.021 inch microcatheter, was effective in prompt occlusion of target vessels in both peripheral and neurovascular applications.

Abstract 125: Treatment of Intracranial Aneurysms With the LUNA AES Updated

Purpose: The LUNA Aneurysm Embolization System (AES) is a new self-expanding ovoid device that serves as an intra saccular flow diverter as well as a scaffold for endothelization across the neck. The objective of this prospective clinical study aiming to include a total of 63 patients was to evaluate the ability of the AES to occlude intracranial aneurysms while maintaining patency of the parent artery. Materials and Methods: Immediate post-implantation occlusion grade (complete (complete obliteration of the aneurysm including the neck), near-complete (persistence of any portion of the original defect of the arterial wall), or incomplete (any opacification of the sac) compared to baseline), and parent vessel compromise were evaluated. Patients underwent neurological testing with the Modified Rankin Scale and the National Institute of Health Stroke Scale (NIHSS) at baseline and time of discharge. Follow-up included clinical assessment at one, 3, 6, 9 and 12 months, and angiographic follow-up at 6 and 12 months. Results: 50 patients (9 men) with 47 unruptured and 4 ruptured saccular aneurysms (38 bifurcation, 13 sidewall, sizes from 3.9 to 10.1 mm) were enrolled to date in the study. In all but 2 aneurysms (2 failed procedure converted in coiling) 1 LUNA AES was deployed per aneurysm. In 5 cases, the LUNA AES placement was carried out with balloon microcatheter assistance. In one case, the LUNA AES placement was carried out with a stent. Clinical follow up was uneventful in all but 2 patients (one sustained SAH from a contralateral MCA aneurysm, one had GI bleeding). Immediate complete/near complete occlusion was obtained in 26.5% (13/49). At 6 month follow-up, complete/near complete occlusion was obtained in 70.8% (34/48). There was no parent artery occlusion. None of the treated aneurysm (re)bled during follow-up. 4 aneurysms treated with the LUNA needed retreatment (2 incomplete deployment of the LUNA into the sac, 2 angiographic recurrences). Conclusion: Preliminary results demonstrate good safety profile. Angiographic follow up are promising.

Have we found the ideal plug for post‐TAVR paravalvular leaks?

Have we found the ideal plug for post‐TAVR paravalvular leaks?

Re: Is valve choice a significant determinant of paravalvular leak post-transcatheter aortic valve implantation? A systematic review and meta-analysis

Paravalvular regurgitation (PVR) significantly increases mortality from 35.3% for mild PVR to 60.8% for moderate-to-severe PVR as reported in the PARTNER trial in 3-year transcatheter aortic valve implantation (TAVI) outcomes [1]. PVR results from incomplete apposition of the prosthesis to the aortic annulus. Recognizing the underlying mechanism is important to improve TAVI outcomes further. Understanding the ethology of what might seem a simple equation of two variables—first, the aortic valve and root complex and second, the TAVI device—is a challenging undertaking. Additional variables add to the complexity leading to PVR after TAVI. Adequate imaging focusing not only on annular diameter, but also on circularity, distribution of aortic valve calcifications or left ventricular outflow tract (LVOT)/aortic root angulation, impacts on the choice of device size and type. Mechanical properties and stent design as well as access direction or delivery strategies are further determinants of PVR and subsequently survival outcomes. Assessment and quantification of PVR are not standardized, and the degree of regurgitation of various studies is difficult to compare. At present, even the adoption of the Valve Academic Research Consortium (VARC) consensus document [2], the standard classification used to describe regurgitation in native valves, does not guarantee comparable PVR assessments. Multi-located eccentric jets make quantitative echocardiographic evaluation difficult. Stent and calcification induced shadowing interfere with flow signals and transthoracic two-dimensional echocardiography might underestimate the degree of regurgitation. When interpreting the present meta-analysis data, those facts need to be considered carefully. In this issue, O’Sullivan et al. [3] reviewed the literature reporting on PVR after TAVI. Nine publications including nearly 6000 patients were identified to report PVR data of either the balloon-expandable Edwards Sapien (ES; four publications) or the self-expanding Medtronic Corevalve (MCV) device (two publications) or both devices (seven publications). To support their observational conclusion that the selfexpanding MCV device has a significantly higher rate of PVR compared with the balloon-expandable ES valve, the authors defined two variables: first, modifiable factors being technological issues and second, non-modifiable factors being anatomical considerations leading to PVR. In particular, as modifiable factors were identified: stent design including material properties and construction particularities, deployment position and prosthesis/annulus mismatch including sizing. Non-modifiable factors predisposing to PVR were the angle between LVOT and aortic root as well as aortic valve calcifications. Even though the France 2 register [4] and the UK TAVI registers [5] indicate that the antegrade transapical TAVI approach has a significantly lower incidence of PVR when compared with all retrograde routes, the authors did not analyse the impact of access route on PVR in this paper. The authors primarily discuss stent designs, material characteristics and deployment technique as modifiable factors for PVR. An MCV self-expanding nitinol stent having continuous radial expansion forces results in higher compliance in the non-circular anatomy. In comparison, an ES stainless steel stent exhibits a higher stiffness better withstanding the compressive forces of the calcified valve resulting in high degree of circularity in 98.5% of implants [6]. Valve positioning and prosthesis/annulus incongruence are further elaborated under valve-related modifiable factors leading to PVR. Despite the evidence for increased PVR and the intrinsic insight into the mechanistic origin of PVR in the MCV device, there are limitations to be considered. The absence of randomized studies comparing the two devices in all-comers presents an important draw back. The choice of device type might be influenced by anatomical considerations and site-specific consideration, for example favouring a self-expanding device in a massively calcified aortic valve. Accordingly, an ES device is favoured in the hostile setting of strong LVOT/aortic root angulation. Both conditions might lead to increased PVR in either device and induce a device selection bias. Mechanistic insights into PVR after TAVI set aside, the authors in their meta-analysis found a significant increase in PVR in patients undergoing an MCV implantation compared with those undergoing an ES implantation. Further studies are mandatory to confirm the present findings.

In Vitro Reproduction of Device Deformation Leading to Thrombotic Complications and Failure of Flow Diversion

Flow diverters (FDs) are increasingly used for complex intracranial aneurysms. As these self-expanding devices are deployed across an aneurysm neck, they can undergo deformations. The potential clinical consequences of FD deformations remain unclear. We describe an immediate thrombotic complication attributed to a stereotypical stenotic deformation of an FD extremity that can occur when landing zones are of insufficient length. This case is supplemented with in vitro studies showing the relationship between i) the length of the landing zones and ii) discrepancies between the diameter of the device and recipient vessel, and the severity of FD stenosis. In vitro, a shorter landing zone was associated with a progressive stenotic deformation of the terminal ends of all FDs studied. This deformation was more pronounced when the diameter of the device was oversized compared to the size of the recipient tube. In our clinical case, the presence of this deformation led to an immediate thrombotic complication, requiring deployment of a second stent to correct the observed stenosis. In addition, treatment failure ultimately led to a fatal rupture, a failure that can be explained by residual flows through a more porous transition zone, another characteristic FD deformation which occurs when they are oversized as compared to the parent vessel, but free to expand at the level of the aneurysm. Proper selection of device diameter and length of the landing zone is important, and may decrease the incidence of deformation-related complications.

Significance of the learning curve in left atrial appendage occlusion with two different devices

To evaluate the impact of learning on outcome with use of two different left atrial appendage (LAA) occlusion devices. Two self-expanding devices, the Watchman and the Amplatzer Cardiac Plug (ACP), have been used for LAA occlusion in the last few years. It has been demonstrated that complications associated with implantation decrease in frequency with operator experience. However, the role of operator experience has not been compared across the two device types. The study comprises 31 consecutive patients who underwent LAA occlusion. We compare the first 10 patients in whom an ACP was implanted with the subsequent eleven patients who underwent ACP implantation and with 10 cases where a Watcthman device was implanted. The composite safety end point comprised procedure-related events and excessive bleeding events. We also performed 3 months echocardiographic and clinical follow-up. There were not significant differences in the basal clinical and echocardiographical characteristics across the three groups. Cardiac complications only occurred in the ACP initial experience group (9% vs. 0% vs. 0% P = 0.04). Echocardiographic and clinical follow-up at 3 months was completed in all patients. No significant residual leak was detected. One patient in the ACP initial experience group developed a thrombus on the device. One patient in ACP late experience presented an ischemic stroke. Complications associated with LAA occlusion cluster early in the peri-procedural period and significantly decrease in frequency with operator experience. Initial experience gained with one of device may improve outcome with use of alternative LAA occlusion devices.

TCT-688 Left Atrial Appendage Closure Using the Amulet Device - A Single Center Experience

Amulet Device (St Jude Medical, Minneapolis, MN, USA) is a new self-expanding device specifically designed for LAA closure. It was designed to facilitate the implantation process and minimize procedural or device-related complications. The Amulet Device was implanted in 17 patients with non-