Early Experience With Transcatheter Mitral Valve Replacement: A Systematic Review

Abstract

Background Transcatheter mitral valve replacement (TMVR) has emerged as an alternative therapeutic option for the treatment of severe mitral regurgitation in patients with prohibitive or high surgical risk. The aim of this systematic review is to evaluate the clinical procedural characteristics and outcomes associated with the early TMVR experience. Methods and Results Published studies and international conference presentations reporting data on TMVR systems were identified. Only records including clinical characteristics, procedural results, and 30-day and midterm outcomes were analyzed. A total of 16 publications describing 308 patients were analyzed. Most patients (65.9%) were men, with a mean age of 75 years (range: 69-81 years) and Society for Thoracic Surgery Predicted Risk of Mortality score of 7.7% (range: 6.1-8.6%). The etiology of mitral regurgitation was predominantly secondary or mixed (87.1%), and 81.5% of the patients were in New York Heart Association class III or IV. A transapical approach was used in 81.5% of patients, and overall technical success was high (91.7%). Postprocedural mean transmitral gradient was 3.5 mm Hg (range: 3-5.5 mm Hg), and only 4 cases (1.5%) presented residual moderate to severe mitral regurgitation. Procedural and all-cause 30-day mortality were 4.6% and 13.6%, respectively. Left ventricular outflow obstruction and conversion to open heart surgery were reported in 0.3% and 4% of patients, respectively. All-cause and cardiovascular-related mortality rates were 27.6% and 23.3%, respectively, after a mean follow-up of 10 (range: 3 to 24) months. Conclusions TMVR was a feasible, less invasive alternative for treating severe mitral regurgitation in patients with high or prohibitive surgical risk. TMVR was associated with a high rate of successful valve implantation and excellent hemodynamic results. However, periprocedural complications and all-cause mortality were relatively high.

Keywords: mitral valve disease; transcatheter cardiac therapeutics; transcatheter mitral valve replacement.

Figure 1

Flow diagram based on the Preferred Reported Items for Systematic Reviews and Meta‐Analysis (PRISMA) statement of studies and international conference presentations for evaluating early experience with TMVR. TMVr indicates transcatheter mitral valve repair; TMVR, transcatheter mitral valve replacement.

Figure 2

Transcatheter mitral valve replacement (TMVR) devices. A, AltaValve, provided by 4C Medical. B, Fluoroscopic image of the AltaValve. C and D, Provided by Caisson TMVR‐LivaNova: Caisson TMVR (C); fluoroscopy image of the Caisson TMVR (D). E, CardiAQ Valve, provided by Edwards Lifesciences. F, Fluoroscopy image of the CardiAQ Valve. G and H, Courtesy of Dr Francesco Maisano, Heart Center University Hospital, Zurich, Switzerland: CardioValve (G); fluoroscopy image of the CardioValve (H). I and J, Reprinted from Regueiro et al15 with permission from Elsevier: Fortis (I); fluoroscopy image of the Fortis (J). K and L, Courtesy of HighLife Medical: HighLife (K); fluoroscopy image of the HighLife (L). M and N, Courtesy of Dr Vinayak Bapat, New York Presbyterian Hospital/Columbia University Medical Center: Intrepid TMVR (M); fluoroscopy image of the Intrepid TMVR (N). O, MValve System. P, Fluoroscopy image of the MValve System, courtesy of Dr Maurice Buchbinder, Stanford University/VA Palo Alto Healthcare System, California. Q and R, Provided by Neovasc Medical Inc: Tiara (Q); fluoroscopy image of the Tiara (R). S and T, Courtesy of Dr John Webb, St. Paul's Hospital, Vancouver, Canada: Sapien M3 System (S); fluoroscopy image of the Sapien M3 System (T). U, Tendyne. W, Fluoroscopy image of the Tendyne.