Prospective Evaluation of Transseptal TMVR for Failed Surgical Bioprostheses

Guerrero, Mayra; Pursnani, Amit; Narang, Akhil; Salinger, Michael H.; Wang, Dee Dee; Eleid, Mackram F.; Kodali, Susheel; George, Isaac; Satler, Lowell F.; Waksman, Ron; Meduri, Christopher; Rajagopal, Vivek; Inglessis, Ignacio; Palacios, Igor F.; Reisman, Mark; Eng, Marvin H.; Russell, Hyde M.; Pershad, Ashish; Fang, Kenith; Kar, Saibal; Makkar, Rajj; Saucedo, Jorge; Pearson, Paul J.; Bokhary, Ujala; Kaptzan, Tatiana; Lewis, Brad; Tommaso, Carl L.; Krause, Philip R.; Thaden, Jeremy J.; Oh, Jae K.; Lang, Roberto M.; Hahn, Rebecca T.; Leon, Martin B.; O’Neill, William W.; Feldman, Ted; Rihal, Charanjit S.

doi:10.1016/j.jcin.2021.02.027

Cited by 47 publications

(41 citation statements)

References 21 publications

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“…Cardiac rupture incidence was higher in our study compared to earlier publications that reported rates between 0.4% and 1.1% 4,8 . However, the rare occurrence of LVOT obstruction is consistent with recent prospective studies that demonstrated the importance of an accurate CT‐scan assessment to prevent such outcome 9,10 . In our study we found a 2% incidence of device malposition requiring second valve implantation, which is much lesser than all the retrospective observational data available 5,7 .…”

Section: Discussionsupporting

confidence: 89%

Mitral valve‐in‐valve and valve‐in‐ring procedures: Midterm outcomes in a French nationwide registry

Ruz

Guérin

Leurent³

et al. 2022

Cathet Cardio Intervent

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Objectives Report contemporary outcomes in patients included in the Mitragister registry and treated with transcatheter mitral valve implantation for failed surgical annuloplasty rings or deteriorated bioprosthesis. Background Midterm survival rates have been reported, but little is known about contemporary morbimortality endpoints. Methods The primary safety outcome was the technical success rate. The primary efficacy composite endpoint was a composite of cardiovascular mortality and heart failure hospitalizations. Results From 2016 to 2021, 102 patients (median age: 81 [74;84] years, 61% female, Euroscore II 11.0% [7.8;16.0]) undergoing valve‐in‐valve (ViV; n = 89) or valve‐in‐ring (ViR; n = 13) procedures were consecutively included. At baseline, ViR group patients had worse left ventricular ejection fraction (50% vs. 60%; p = 0.004) and more frequently severe regurgitation (46% vs. 15%; p = 0.014). The primary safety outcome was 95%: 77% and 98% in the ViR and ViV populations, respectively, (p = 0.014). At intermediate follow‐up (6–12 months) clinical improvement was notable, 88% of the patients were in NYHA class ≤ II (vs. 25% at baseline; p < 0.001). At a mean follow‐up of 17.1 ± 11.0 months, the primary efficacy composite reached 27%. By multivariate analysis, paravalvular leak (PVL) was the only independent predictor (hazard ratio: 2.39, 95% confidence interval: 1.08–5.29; p = 0.031) while ViR was not found statistically associated (p = 0.456). Conclusions This study confirms the safety and efficacy of the mitral ViV procedure. ViR patients appear at higher risk of procedural complications. The presence of PVL could be associated with markedly worse midterm prognosis. Whatever the intervention, procedural strategies to reduce PVL incidence remain to be assessed to prevent latter adverse outcomes.

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Section: Discussionsupporting

confidence: 89%

Mitral valve‐in‐valve and valve‐in‐ring procedures: Midterm outcomes in a French nationwide registry

Ruz

Guérin

Leurent³

et al. 2022

Cathet Cardio Intervent

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“…Here, we show that there was a strong connection between Current TMVR VIV literature observed higher post-VIV mitral mean gradients to be associated with worse clinical outcomes. 4,17 In the VIVID registry, fewer TMVR VIV devices met the MVARC device success criteria primarily due to findings of transmitral mean gradients ≥5 mmHg post-TMVR VIV. 5 Patients with post-TMVR VIV mitral mean gradients ≥10 mmHg were noted to have higher likelihood of developing clinical symptoms of heart failure and needing reintervention.…”

Section: Discussionmentioning

confidence: 99%

Comparative differences of mitral valve‐in‐valve implantation: A new mitral bioprosthesis versus current mosaic and epic valves

Wang

O’Neill

Caranasos

et al. 2021

Cathet Cardio Intervent

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Objective: Evaluate transcatheter mitral valve replacement (TMVR) valve-in-valve (VIV) outcomes in three different mitral bioprostheses (of comparable measured internal diameters) under stable hemodynamic and surgical conditions by bench, echocardiographic, computerized tomography (CT), and autopsy comparisons preand post-valve implantation in a porcine model under matched controlled conditions.Background: Impact of surgical bioprosthesis design on TMVR VIV procedures is unknown.Methods: Fifteen similar-sized Yorkshire pigs underwent pre-procedural CT screening. Twelve had consistent anatomic features and underwent implantation of mitral bioprostheses. Four valves from each of three manufacturers were implanted in randomized fashion: 27-mm Epic, 27-mm Mosaic, and 25-mm Mitris, followed by TMVR VIV with 26 Edwards Sapien3. Post-VIV, suprasternal TEE studies were performed to assess hemodynamic function, followed by a gated contrast CT. After euthanasia, animals underwent necropsy for anatomic evaluation.Results: All 12 animals had successful VIV implantation with no study deaths. The post vivMitris (3.77 ± 0.36)/(2.2 ± 0.25 mmHg) had the lowest peak/mean transmitral gradient and the vivEpic the highest (15.5 ± 2.55)/(7.09 ± 1.13 mmHg). All THVs (transcatheter heart valves) had greatest deformation within the center of the THV frame; with the smallest waist opening area in the vivEpic (329 ± 35.8 mm 2 ) and greatest in the vivMitris (414 ± 33.12 mm 2 ). Bioprosthetic frames without obvious radiopaque markers resulted in the most ventricular implantation of the THV's anteroseptal frame (Epic: À4.52 ± 0.76 mm), versus the most radiopaque bioprosthesis (Mitris: À1.18 ± 2.95 mm), and higher peak LVOT gradients (Epic: 4.82 ± 1.61 mmHg; Mitris: 2.91 ± 1.47 mmHg). Conclusions:The current study demonstrates marked variations in hemodynamics, THV opening area, and anatomic dimensions among measured similarly sized mitral

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“…Recently, data focusing on transseptal TMVI in these three settings have been collected in the MITRAL trial ( 12 ): of the 30 patients enrolled in the ViV group, the procedural success was 100% and only one death was observed at both 30-day and 1-year follow-ups. In addition, most patients experienced an improvement in symptoms and all patients showed MR grade ≤ 1 after 1 year.…”

Section: Tmvi Outcomesmentioning

confidence: 99%

“…According to surgical experience, MV repair should be considered as the first option treatment to address severe MR. Actually, there are a number of reasons to consider MV repair over MV replacement. First, TEER with MitraClip sets the bar high in terms of safety and efficacy: based on a recent systematic review comparing COAPT results (302 patients) with the pooled data of multiple TMVI devices (308 patients) the 30-day mortality value was 2.3 vs. 13.6% ( 12 ). Second, MV repair is more respectful of MV complex (leaflets, annulus, chordae, papillary muscles, LA, and the aortic valve continuity).…”

Section: Repair or Replacement?mentioning

confidence: 99%

“…In such anatomies, TMVI should be considered as a possible treatment. The main advantage for TMVI is its reproducibility with MR complete resolution in almost all cases whereas moderate/severe residual MR is more common in patients undergoing a repair with MitraClip ( 12 ). In addition, MV repair is less predictable and more operator-dependent as demonstrated by the recent data from the TVT registry showing how the experiences of institutions and operators impact MV repair outcomes ( 29 ).…”

Section: Repair or Replacement?mentioning

confidence: 99%

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Challenges and Open Issues in Transcatheter Mitral Valve Implantation: Smooth Seas Do Not Make Skillful Sailors

Russo

Massaro

Terlizzese

et al. 2022

Front. Cardiovasc. Med.

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According to the European and American guidelines, surgery represents the treatment of choice for mitral valve (MV) disease. However, a number of patients are deemed unsuitable for surgery due to a prohibitive/high operative risk. In such cases, transcatheter therapies aiming at MV repair have been proven to be a valuable alternative and have been recently introduced in the latest American guidelines on valvular heart disease. Indeed, percutaneous repair techniques, particularly transcatheter edge-to-edge, have gained a broad experience and demonstrated to be safe and effective. However, given the complexity and heterogeneity of MV anatomy and pathology, transcatheter MV implantation (TMVI) has grown as a possible alternative to percutaneous MV repair. Current data about TMVI are still limited and come from different settings: valve-in-native MV, valve-in-valve (ViV), valve-in-ring (ViR), and valve-in-mitral annular calcification. Preliminary data are promising although several open issues still need to be addressed. This paper provides a comprehensive review of the available devices in the different clinical settings, to discuss potentialities, limitations, and future directions for TMVI.

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Prospective Evaluation of Transseptal TMVR for Failed Surgical Bioprostheses

Cited by 47 publications

References 21 publications

Mitral valve‐in‐valve and valve‐in‐ring procedures: Midterm outcomes in a French nationwide registry

Mitral valve‐in‐valve and valve‐in‐ring procedures: Midterm outcomes in a French nationwide registry

Comparative differences of mitral valve‐in‐valve implantation: A new mitral bioprosthesis versus current mosaic and epic valves

Challenges and Open Issues in Transcatheter Mitral Valve Implantation: Smooth Seas Do Not Make Skillful Sailors

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