Safety and efficacy of the MitraClip<sup>®</sup> system for severe mitral regurgitation

Vakil, Kairav; Roukoz, Henri; Sarraf, Mohammad; Krishnan, Balaji; Reisman, Mark; Levy, Wayne C.; Adabag, Selçuk

doi:10.1002/ccd.25347

Cited by 58 publications

(46 citation statements)

References 32 publications

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“…In another study by Schäfer et al17 examining the impact of preprocedural LV ejection fraction on the outcome of MitraClip therapy in 393 patients with functional mitral regurgitation, the authors found a significant increase in 6MWT, which was most pronounced in those with an LV ejection fraction >40% (+69.8±103.3 meters) followed by those with an LV ejection fraction of 10% to 20% (61.1±150.3 meters). In a meta‐analysis of 2980 patients, Vakil et al19 found an increase in 6MWT from 261±14 meters at baseline to 360±25 meters at follow‐up. In our study, 6MWT increased from 160±116 to 267±132 meters.…”

Section: Discussionmentioning

confidence: 99%

Comparison of Deep Sedation With General Anesthesia in Patients Undergoing Percutaneous Mitral Valve Repair

Patzelt

Ulrich

Magunia

et al. 2017

JAHA

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BackgroundPercutaneous edge‐to‐edge mitral valve repair (PMVR) has become an established treatment option for mitral regurgitation in patients not eligible for surgical repair. Currently, most procedures are performed under general anesthesia (GA). An increasing number of centers, however, are performing the procedure under deep sedation (DS). Here, we compared patients undergoing PMVR with GA or DS.Methods and ResultsA total of 271 consecutive patients underwent PMVR at our institution between May 2014 and December 2016. Seventy‐two procedures were performed under GA and 199 procedures under DS. We observed that in the DS group, doses of propofol (743±228 mg for GA versus 369±230 mg for DS, P<0.001) and norepinephrine (1.1±1.6 mg for GA versus 0.2±0.3 mg for DS, P<0.001) were significantly lower. Procedure time, fluoroscopy time, and dose area product were significantly higher in the GA group. There was no significant difference between GA and DS with respect to overall bleeding complications, postinterventional pneumonia (4% for GA versus 5% for DS), or C‐reactive protein levels (361±351 nmol/L for GA versus 278±239 nmol/L for DS). Significantly fewer patients with DS needed a postinterventional stay in the intensive care unit (96% for GA versus 19% for DS, P<0.001). Importantly, there was no significant difference between DS and GA regarding intrahospital or 6‐month mortality.Conclusions DS for PMVR is safe and feasible. No disadvantages with respect to procedural outcome or complications in comparison to GA were observed. Applying DS may simplify the PMVR procedure.

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Section: Discussionmentioning

confidence: 99%

Comparison of Deep Sedation With General Anesthesia in Patients Undergoing Percutaneous Mitral Valve Repair

Patzelt

Ulrich

Magunia

et al. 2017

JAHA

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“…Major complications reported from the EVEREST II trial and a four-year MitraClip follow up study include major bleeding, stroke or transient ischemic attack, chordal rupture, pericardial tamponade and myocardial infarction; endocarditis, however, was not one of the reported complications in the landmark EVEREST II trial [18,19]. There have been only a few reported cases of patients with infective endocarditis in the region of the MitraClip [9,10].…”

Section: Discussionmentioning

confidence: 99%

Early Endocarditis Following Percutaneous Mitral Repair in a Dialysis Patient

Vp¹,

Kennedy-Snodgrass²,

Kerwin³

2018

J Integr Cardiol

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Transcutaneous mitral valve repair is an interventional procedure increasingly used as a method of treatment for patients with symptomatic mitral regurgitation deemed to be poor surgical candidates. The procedure involves clipping the mitral valve leaflets at the point of maximal regurgitation. This procedure has been shown to be well tolerated with an acceptable risk profile. Infective endocarditis is a known but unusual complication of this procedure. We describe a case of infective endocarditis following implantation of a MitraClip (Abbott Laboratories) in a hemodialysis patient.

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“…0.1%), while its long-term rate increased by 15.8%. It should be noted that the mortality rate as a side effect of the Mitraclip is related to the patient's risk level; therefore, safety is significantly different in high-risk and lowrisk groups (10).…”

Section: Discussionmentioning

confidence: 99%

The Application of Mitraclip in the Treatment of Mitral Regurgitation: A Clinical Policy

et al. 2018

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Context: The mitral valve conducts blood flow from the left atrium to the left ventricle. Mitral regurgitation occurs when the valve couldn't be closed properly at the end of ventricular filling. Mitraclip, a catheter-based device that can reduce mitral regurgitation without requiring open surgery, is routinely used for patients with unacceptable risk of conventional mitral valve repair or replacement. The purpose of this study is assessing the safety, efficacy, and economic aspects of Mitraclip treatment for mitral regurgitation.Evidence Acquisition: The Cochrane Library, the TRIP database, and Google Scholar have been searched through appropriate strategies. Seven studies were included in the final phase based on the inclusion and exclusion criteria. Data collected from these studies were analyzed based on four main themes; applications, safety, efficacy, and economic evaluation. Results:The most potential side effects were related to an improper transfer of catheters and low durability of the device. One of the included studies showed that improved outcomes of the New York Heart Association (NYHA) was more in the clip group with better quality of life that were observed after 1 to 12 months in 192 patients and also one-year mortality rate after using clip ranged between 10% and 24%. This included study found that 72% to 100% of patients with Mitraclip have been successfully treated and the duration of hospital stays in these patients was between 5 to 10 days. The cost-effectiveness of the procedure still needs more robust evidence. Conclusions:Given the lack of high quality evidence and relatively high cost of Mitraclip, it seems that until further robust evidence is produced; it should be used in research and in high risk patients selected after detailed examination with strict indications and appropriate opinions of cardiologists.

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Safety and efficacy of the MitraClip^® system for severe mitral regurgitation

Abstract: MitraClip® implantation for moderate to severe or severe MR appears to be safe with a very low procedural mortality. There is significant improvement in functional outcomes although long-term mortality is high, especially in high surgical risk patients.

Cited by 58 publications

References 32 publications

Comparison of Deep Sedation With General Anesthesia in Patients Undergoing Percutaneous Mitral Valve Repair

Comparison of Deep Sedation With General Anesthesia in Patients Undergoing Percutaneous Mitral Valve Repair

Early Endocarditis Following Percutaneous Mitral Repair in a Dialysis Patient

The Application of Mitraclip in the Treatment of Mitral Regurgitation: A Clinical Policy

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Safety and efficacy of the MitraClip® system for severe mitral regurgitation

Abstract: MitraClip® implantation for moderate to severe or severe MR appears to be safe with a very low procedural mortality. There is significant improvement in functional outcomes although long-term mortality is high, especially in high surgical risk patients.

Cited by 58 publications

References 32 publications

Comparison of Deep Sedation With General Anesthesia in Patients Undergoing Percutaneous Mitral Valve Repair

Comparison of Deep Sedation With General Anesthesia in Patients Undergoing Percutaneous Mitral Valve Repair

Early Endocarditis Following Percutaneous Mitral Repair in a Dialysis Patient

The Application of Mitraclip in the Treatment of Mitral Regurgitation: A Clinical Policy

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Safety and efficacy of the MitraClip^® system for severe mitral regurgitation