First-in-man experience with a new embolic deflection device in transcatheter aortic valve interventions

Onsea, Kevin; Agostoni, Pierfrancesco; Samim, Mariam; Voskuil, Michiel; Kluin, Jolanda; Budde, Ricardo P.J.; Hendrikse, Jeroen; Ramjankhan, Faiz; Klarenbosch, Jan van; Doesburg, Pieter; Sieswerda, Gertjan T.; Stella, Pieter R.

doi:10.4244/eijv8i1a9

Cited by 74 publications

(45 citation statements)

References 15 publications

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“…In our cases clopidogrel and warfarin was given for one month for the INR to be 2.0-2.5, and only warfarin treatment was applied after a month. Additionally new emboli protecting devices are being developed (e. g., Embrella [Edwards Lifesciences, Inc., Irvine, CA, USA], Claret [Claret Medical, Inc. Santa Rosa, CA, USA], SMT Embolic Deflection Device) in order to prevent process related emboli and the human studies regarding these are promising [12]. As far as we know no TAVI case is found for patients with AF and thrombus in LAA in the literature.…”

Section: Discussionmentioning

confidence: 99%

“…Age, hypertension, diabetes, calcified ascending aorta, female gender, story of stroke, AF and the degree of the atheroma plates in the aortic arch are included in the risk factors for emboli [6,12]. New AF related to TAVI which causes an increase in post procedural stroke risk for 3.9 times was determined to be 7.5% in the transfemoral arm, 11.5% in the transapical arm of cohort A, and 0.7% in cohort B of PARTNER [3,12].…”

Section: Discussionmentioning

confidence: 99%

“…Emboli might be observed in every stage of the TAVI process such as left heart catheterisation, catheter manipulations, thrombus formation around the catheter or the sheath, calcified aortic valve tear up during balloon valvuloplasty, valve position and implantation and the extended time period after the process [11]. Age, hypertension, diabetes, calcified ascending aorta, female gender, story of stroke, AF and the degree of the atheroma plates in the aortic arch are included in the risk factors for emboli [6,12]. New AF related to TAVI which causes an increase in post procedural stroke risk for 3.9 times was determined to be 7.5% in the transfemoral arm, 11.5% in the transapical arm of cohort A, and 0.7% in cohort B of PARTNER [3,12].…”

Section: Discussionmentioning

confidence: 99%

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Transcatheter Aortic Valve Implantation in Patients With Left Atrial Appendix Thrombus

et al. 2014

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Aim. The transcatheter aortic valve implantation (TAVI) which developed in the recent years has become an alternative for surgery. However, in spite of new developments the process based vascular and neurological complications still remain to be a problem with elderly patients who also tend to have many co-morbid conditions. With this study we aimed to evaluate the TAVI efficacy and reliability on patients with scarcely relative contraindication and with intracardiac thrombus who are mostly left out of the study. Methods and Results. There has been a successful TAVI process conducted in our clinic for antiplatelet and anticoagulation for 6 cases in which thrombus was seen in left atrial appendix (LAA) via transesophageal echocardiography (TEE) and which are not suitable for surgical valve replacement due to atrial fibrillation (AF) and severe AS comorbid reasons. Edwards SAPIEN XT valve was implanted to all patients transfemorally with general anaesthesia. The process was facilitated successfully and no major/minor stroke was observed in post-process early period, and 9 month controls, in average. Conclusion. Other than AS, also AF, whose frequency increases with age, is an important risk factor for neurological complications. In patients who has AF and AS the source of the cardioembolic focus is mainly LAA. The post-TAVI antiplatelet and anticoagulation treatment is not clear for these patients. We tried to show that TAVI process is reliable in terms of the risk of stroke, in careful processing and suitable anticoagulation treatment for the patients with AF, AS and LAA in this first case study in literature, as far as we know. Цель. Транскатетерная имплантация аортального клапана (ТИАК), которая развивалась в последние годы, стала альтернативой для хирургии. Однако, несмотря на новые разработки, сосудистые и неврологические осложнения, лежащие в основе процесса, по-прежнему остаются проблемами у пожилых пациентов, которые, как правило, имеют много сопутствующих заболеваний. В данном исследовании мы стремились оценить эффективность и надеж-ность ТИАК у пациентов с опасными противопоказаниями и с внутрисердеч-ными тромбами, которые в большинстве случаев не включаются в исследо-вания. Методы и Результаты. Имелись успешные ТИАК, проведенные в нашей кли-нике для антитромбоцитарного и антикоагулянтного лечения 6 случаев, в которых тромб был замечен в ушке левого предсердия (LAA) с помощью чреспищеводной эхокардиографии, и которые являются не пригодными для выполнения хирургической операции по замене клапана вследствие фибрил-ляции предсердий (ФП) и тяжелого стеноза аорты (СА). Клапан Edwards SAPIEN XT был имплантирован всем пациентам трансфеморально под общей анестезией. Процесс был успешно проведен и не было отмечено большого/ малого инсульта в раннем пост-операционном периоде, а также во время 9-месячного контроля, в среднем. Заключение. СА, как и ФП, чья частота увеличивается с возрастом, являются важным фактором риска развития неврологических осложнений. У пациентов, которые уже имеют ФП и СА, кардиоэмболический ...

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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Transcatheter Aortic Valve Implantation in Patients With Left Atrial Appendix Thrombus

et al. 2014

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“…The SMT FIM (first in man) feasibility study described the use of the SHEF device in the first 15 patients. 62 The ongoing DEFLECT I (SMT Embolic Deflection CE Mark) study is expected to provide further evidence of the effectiveness of the device. First results have been presented at EuroPCR in May 2013 in Paris and show promising results.…”

Section: Renalna Denervacijamentioning

confidence: 99%

Almanac 2013: novel non-coronary cardiac interventions

Meier

Franzen²,

Lansky³

2013

Cardiol Croat.

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SAAEETAK:Aktualne inovacije u intervencijskoj kardiologiji dramatiËno su proπirile terapijske moguÊnosti za srËa-ne bolesnike. Intervencijska kardiologija viπe nije ograniËena na lijeËenje koronarne bolesti srca veÊ je moguÊe lijeËiti bolesti zalistaka, raditi na prevenciji moaedanog udara, lijeËenju arterijske hipertenzije, itd. Jedna od najvaaenijih novih moguÊnosti lijeËenja je perkutano lijeËenje aortne stenoze (transkateterska implantacija aortne valvule), buduÊi da je bolest aortne valvule vrlo Ëest problem u bolesnika starije aeivotne dobi, a mnogi od njih imaju visok rizik od operacije. Isto tako, mitralna regurgitacija je Ëesto povezana s pojavom komorbiditeta koji Ëine operaciju visokoriziËnom. MitraClip je obeÊavajuÊe perkutano alternativno rjeπenje za kirurπki popravak ili zamjenu srËanog zaliska. Ostali postupci koji se spominju u ovom preglednom Ëlanku su perkutano zatvaranje aurikule lijevog atrija kao nefarmakoloπka terapija za prevenciju moaedanog udara, renalna denervacija za rezistentnu arterijsku hipertenziju. U ovom se Ëlanku pojaπnjavaju osnovni principi ovih postupaka, najvaaenije kliniËke studije uz dodatne kliniËke podatke o svakom od njih. KLJU»NE RIJE»I: intervencijska kardiologija, intervencijski zahvati na zaliscima. SUMMARY:Recent innovations in interventional cardiology have dramatically expanded the therapeutic options for patients with cardiac conditions. Interventional cardiology is no longer limited to the treatment of coronary artery disease but allows also treatment of valvular disease, stroke prevention, hypertension, etc. One of the most important new treatment options is the percutaneous treatment for aortic valve stenosis (transcatheter aortic valve implantation), since aortic valve disease is a rather common problem in elderly patients, with many of them at high risk for surgery. Similarly, mitral regurgitation is often associated with comorbidities which make surgery high risk. The MitraClip is a promising percutaneous alternative to surgical valve repair or replacement. Other procedures discussed in this review are the percutaneous left atrial appendage closure as a non-pharmacologic therapy to prevent strokes, and renal denervation for resistant hypertension. This review explains the basic principles of these procedures, the most important clinical evidence, and also provides additional recent clinical data on each of these them.

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“…The uses of aortic flow deflectors and cerebral protection devices is an appealing concept which has been tested in some preliminary clinical studies which have not yet confirmed the effectiveness of these devices [29,30].…”

mentioning

confidence: 99%

Percutaneous aortic valve replacement has come to stay

Mendiz

2015

Cardiol J

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First-in-man experience with a new embolic deflection device in transcatheter aortic valve interventions

Abstract: In this first-in-man experience, the feasibility of a new embolic deflection device is demonstrated. Larger randomised, prospective studies are required to confirm these findings and prove safety and efficacy by reducing the incidence of cerebral embolism and stroke after TAVI.

Cited by 74 publications

References 15 publications

Transcatheter Aortic Valve Implantation in Patients With Left Atrial Appendix Thrombus

Transcatheter Aortic Valve Implantation in Patients With Left Atrial Appendix Thrombus

Almanac 2013: novel non-coronary cardiac interventions

Percutaneous aortic valve replacement has come to stay

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