Current Status of Catheter-based Mitral Valve Replacement

Rawish, Elias; Schmidt, Tobias; Eitel, Ingo; Frerker, Christian

doi:10.1007/s11886-021-01524-0

Cited by 8 publications

(6 citation statements)

References 58 publications

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“…Owing to the saddle-shaped, dynamic mitral valve annulus and proximity to the left ventricular outflow tract with potential for obstruction, the development of a prosthesis in this location has its unique challenges. A number of prostheses with different designs have been successfully implanted in humans– the CardiAQ™, the Intrepid™, the HighLife™, the Tiara™, the Tendyne™, the AltaValve™, the EVOQUE™, the SAPIEN M3™, and the Cardiovalve™ ( Table 1 ) ( 44 ). Because of technical challenges with the positioning of the device and co-axial prosthesis alignment that involves a 90° turn after crossing the interatrial septum, most of the devices were developed to be deployed through trans-apical access except for the EVOQUE™, the SAPIEN M3™, the Intrepid™, and the Cardiovalve™, which have been successfully deployed in patients through a trans-septal approach utilizing transfemoral vascular access.…”

Section: Structural Interventions Targeting Valvular Heart Disease An...mentioning

confidence: 99%

Restructuring the Heart From Failure to Success: Role of Structural Interventions in the Realm of Heart Failure

Kir

Munagala

2022

Front. Cardiovasc. Med.

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Heart failure through the spectrum of reduced (HFrEF), mid-range (or mildly reduced or HFmEF), and preserved ejection fraction (HFpEF), continues to plague patients' quality of life through recurrent admissions and high mortality rates. Despite tremendous innovation in medical therapy, patients continue to experience refractory congestive symptoms due to adverse left ventricular remodeling, significant functional mitral regurgitation (FMR), and right-sided failure symptoms due to significant functional tricuspid regurgitation (FTR). As most of these patients are surgically challenging for open cardiac surgery, the past decade has seen the development and evolution of different percutaneous structural interventions targeted at improving FMR and FTR. There is renewed interest in the sphere of left ventricular restorative devices to effect reverse remodeling and thereby improve effective stroke volume and patient outcomes. For patients suffering from HFpEF, there is still a paucity of disease-modifying effective medical therapies, and these patients continue to have recurrent heart failure exacerbations due to impaired left ventricular relaxation and high filling pressures. Structural therapies involving the implantation of inter-atrial shunt devices to decrease left atrial pressure and the development of implantable devices in the pulmonary artery for real-time hemodynamic monitoring would help redefine treatment and outcomes for patients with HFpEF. Lastly, there is pre-clinical data supportive of soft robotic cardiac sleeves that serve to improve cardiac function, can assist contraction as well as relaxation of the heart, and have the potential to be customized for each patient. In this review, we focus on the role of structural interventions in heart failure as it stands in current clinical practice, evaluate the evidence amassed so far, and review promising structural therapies that may transform the future of heart failure management.

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Section: Structural Interventions Targeting Valvular Heart Disease An...mentioning

confidence: 99%

Restructuring the Heart From Failure to Success: Role of Structural Interventions in the Realm of Heart Failure

Kir

Munagala

2022

Front. Cardiovasc. Med.

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“…Transcatheter mitral valve replacement (TMVR) has also been an intervention explored in recent years following the relative success of TAVR in working as a minimally invasive alternative to sAVR for patients with aortic stenosis. Mitral regurgitation is the most common valve disease in adults, including almost 10% of people over 75 [7]. However, TMVR is much less popular among physicians than TAVR because of the significant anatomic challenges associated with the mitral valve such as the D-shape of the mitral valve annulus [8].…”

Section: Device Backgroundmentioning

confidence: 99%

“…However, TMVR is much less popular among physicians than TAVR because of the significant anatomic challenges associated with the mitral valve such as the D-shape of the mitral valve annulus [8]. Essentially, it is more difficult to anchor the mitral valve prosthesis because unlike TAVR, the valve fixation cannot be dependent only on radial forces [7]. Advances made by radiologists in computed tomography have become important to address these issues [9].…”

Section: Device Backgroundmentioning

confidence: 99%

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Analyzing Adverse Events of Mitral and Aortic Valves during the Pandemic

Zhou¹,

Bhatia²

2022

JBEB

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The COVID-19 pandemic forced cardiologists to adapt to unprecedented circumstances. We chose to investigate the pandemic's effect on heart valve replacements, in particular focussing on device failure in mitral valve replacements and percutaneous aortic valve prostheses. In order to measure this effect, we examined adverse event reports of these two devices in the Food and Drug Administration (FDA)'s Manufacturer and User Facility Device Experience (MAUDE) database. We compared weekly numbers of adverse event reports during the pandemic (March 2020-March 2021 to those of the year before (March 2019-March 2020. We find that reports of deaths, injuries, and malfunctions attributed to mitral valve repair devices all showed no significant changes during the pandemic, compared to the year preceding. However, we have also found that during the pandemic, there was a 107.4% increase in deaths reported to the FDA that were attributed to percutaneous aortic valve prostheses, and a 45.1% increase in reports of malfunctions as well compared to the year preceding the pandemic. These results suggest that the pandemic may have induced an increase in transcatheter aortic valve replacements vs. surgical aortic valve replacements, leading to an increase in adverse event reports associated with percutaneous aortic valve prostheses. In contrast, transcatheter mitral valve repair is not commonly performed, and the pandemic is unlikely to have changed treatment protocols for mitral valve repair.

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“…Building off the clinical success of TAVR, many investigators in the field are turning their attention to transcatheter mitral valve replacement, or TMVR. Mitral valve disease is the most common valvular disease in the adult population, with patient age being the primary driving factor of the disease 14 , 15 . While more common than aortic valve diseases, the current standard of care for treatment of mitral disease is either surgical valve repair or replacement, both requiring deep anesthesia and open heart surgery.…”

Section: Introductionmentioning

confidence: 99%

Multimodal preoperative imaging for transcatheter mitral valve replacement in the domestic sheep model

Carney,

Bianco

2024

Sci Rep

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Preclinical in vivo evaluation is an essential step in the progression of new cardiac devices into patient use, with studies predominantly performed in the domestic sheep model. A growing area of interest in cardiac device development is transcatheter mitral valve replacement (TMVR). Clinically, multimodal imaging, or computed tomography (CT) and echocardiography (echo) are used extensively to preoperatively determine mitral valve morphology prior to an intervention, but there is no description on how these modalities can be implemented to support preclinical studies. The purpose of this study is to apply clinically relevant CT and echo acquisition and assessment techniques to a large group of naive research sheep in order to analyze and report modality-related effects on mitral valve dimensional reference intervals in the sheep model. To this end, fifty-five adult domestic sheep underwent preoperative CT and echo exams and resultant images were analyzed using a landmark-based multiplanar measurement protocol and compiled into a master dataset for statistical analysis. We found moderate agreement between CT and echo-derived measurements of the mitral valve in sheep and propose the first clinically-relevant dimensional indices for the sheep’s naive mitral valve which can be used to guide future studies evaluating novel TMVR devices. This study is the first of its kind in proposing a reproducible method for detailed examination of the mitral valve in the sheep model using clinically-relevant multimodal imaging. As in patients, CT and echo can reveal accurate native mitral valve dimensions in the sheep prior to preclinical TMVR studies.

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Current Status of Catheter-based Mitral Valve Replacement

Cited by 8 publications

References 58 publications

Restructuring the Heart From Failure to Success: Role of Structural Interventions in the Realm of Heart Failure

Restructuring the Heart From Failure to Success: Role of Structural Interventions in the Realm of Heart Failure

Analyzing Adverse Events of Mitral and Aortic Valves during the Pandemic

Multimodal preoperative imaging for transcatheter mitral valve replacement in the domestic sheep model

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