Clinical outcomes and predictors in patients with previous cardiac surgery undergoing mitral valve transcatheter edge-to-edge repair

Mitral-valve transcatheter edge-to-edge repair (MV-TEER) is recommended in patients with severe functional mitral regurgitation (FMR) and in those with degenerative mitral regurgitation (DMR) not eligible to traditional surgery. Patients with a history of previous cardiac surgery are considered at high risk for surgical reintervention, but data are lacking regarding procedural and clinical outcomes

Implantation of one, two or multiple MitraClip™ for transcatheter mitral valve repair: insights from a 1824-patient multicenter study

24noBACKGROUND: Transcatheter mitral valve repair (TMVR) with MitraClipTM (Abbott Laboratories; Abbott Park, IL, USA) is an established treatment for mitral regurgitation (MR). More than one MitraClipTM may be implanted if a single one does not reduce MR adequately. We aimed to appraise the outlook of patients undergoing implantation of one, two or multiple MitraClipTM for TMVR. METHODS: Exploiting the ongoing prospective GISE Registry of Transcatheter Treatment of Mitral Valve Regurgitation (GIOTTO) Study dataset, we compared patients, procedural details and outcomes distinguishing those receiving one, two or multiple MitraClipTM. The primary endpoint was the composite of 1-year cardiac death or rehospitalization for heart failure. Additional endpoints included all cause death, surgical mitral repair, and functional class. Multivariable adjusted Cox proportional hazard analysis was used for confirmatory purposes. RESULTS: As many as 1824 patients were included: 718 (39.4%) treated with a single MitraClipTM, and 940 (51.5%) receiving two MitraClipTM, and 166 (9.1%) receiving three or more. Significant differences were found for baseline features, including age, female gender, diabetes mellitus, hypertension, chronic obstructive pulmonary disease, prior myocardial infarction, atrial fibrillation, permanent pacemaker, cardiac resynchronization therapy, implantable cardioverter defibrillator, and prior mitral valve repair (all P<0.05). Several imaging features were also different, including left ventricular dimensions, MR severity and proportionality, mitral valve area, flail leaflet, and pulmonary vein flow (all P<0.05). Among procedural features, significant differences were found for anesthesia type, MitraClipTM type, fluoroscopy, device, and operating room times, postprocedural mitral gradient, residual MR, smoke-like effect, device success partial detachment and surgical conversion (all P<0.05). In-hospital death occurred more frequently in patients receiving multiple MitraClipTM, and the same applied severe residual MR (all P<0.05). Mid-term follow-up (15 +/- 13 months) showed significant differences in the risk of death, cardiac death, rehospitalization for heart failure, and their composites, mainly, but not solely, associated with multiple MitraClipTM (all P<0.05). Adjusted analysis confirmed the significantly increased risk of composite adverse events when comparing the multiple vs. single MitraClipTM groups (P=0.014 for death and rehospitalization, P=0.013 for cardiac death or rehospitalization). CONCLUSIONS: Implantation of one or two MitraClipTM is associated with favorable clinical outcomes. Conversely, bail-out implantation of three or more MitraClipTM may portend a worse long-term prognosis. (Cite this article as: Giordano A, Ferraro P, Finizio F, Biondi-Zoccai G, Denti P, Bedogni F, et al. Implantation of one, two or multiple MitraClipTM for transcatheter mitral valve repair: insights from a 1824-patient multicenter study. Panminerva Med 2022;64:1-8. DOI: 10.23736/S00310808.21.04497-9)noneGiordano, Arturo; Ferraro, Paolo; Finizio, Filippo; Biondi-Zoccai, Giuseppe; Denti, Paolo; Bedogni, Francesco; Rubbio, Antonio P; Petronio, Anna S; Bartorelli, Antonio L; Mongiardo, Annalisa; Giordano, Salvatore; DE Felice, Francesco; Adamo, Marianna; Montorfano, Matteo; Baldi, Cesare; Tarantini, Giuseppe; Giannini, Francesco; Ronco, Federico; Monteforte, Ida; Villa, Emmanuel; Ferrario, Maurizio; Fiocca, Luigi; Castriota, Fausto; Tamburino, CorradoGiordano, Arturo; Ferraro, Paolo; Finizio, Filippo; Biondi-Zoccai, Giuseppe; Denti, Paolo; Bedogni, Francesco; Rubbio, Antonio P; Petronio, Anna S; Bartorelli, Antonio L; Mongiardo, Annalisa; Giordano, Salvatore; DE Felice, Francesco; Adamo, Marianna; Montorfano, Matteo; Baldi, Cesare; Tarantini, Giuseppe; Giannini, Francesco; Ronco, Federico; Monteforte, Ida; Villa, Emmanuel; Ferrario, Maurizio; Fiocca, Luigi; Castriota, Fausto; Tamburino, Corrad

Implantation of one, two or multiple MitraClips for transcatheter mitral valve repair: insights from a 1824-patient multicenter study

Transcatheter mitral valve repair (TMVR) with the MitraClip device is an established treatment for mitral regurgitation (MR). More than one MitraClip may be implanted if a single one does not reduce MR adequately. We aimed at appraising the outlook of patients undergoing implantation of one, two or multiple MitraClips for TMVR

MitraClip in secondary mitral regurgitation as a bridge to heart transplantation: 1-year outcomes from the International MitraBridge Registry.

BACKGROUND Patients awaiting heart transplantation (HTx) often need bridging therapies to reduce worsening and progression of underlying disease. Limited data are available regarding the use of the MitraClip procedure in secondary mitral regurgitation for this clinical condition. METHODS We evaluated an international, multicenter (17 centers) registry including 119 patients (median age: 58 years) with moderate-to-severe or severe secondary mitral regurgitation and advanced heart failure (HF) (median left ventricular ejection fraction: 26%) treated with MitraClip as a bridge strategy according to 1 of the following criteria: (1) patients active on HTx list (in list group) (n = 31); (2) patients suitable for HTx but awaiting clinical decision (bridge to decision group) (n = 54); or (3) patients not yet suitable for HTx because of potentially reversible relative contraindications (bridge to candidacy group) (n = 34). RESULTS Procedural success was achieved in 87.5% of cases, and 30-day survival was 100%. At 1 year, Kaplan-Meier estimates of freedom from the composite primary end-point (death, urgent HTx or left ventricular assist device implantation, first rehospitalization for HF) was 64%. At the time of last available follow-up (median: 532 days), 15% of patients underwent elective transplant, 15.5% remained or could be included in the HTx waiting list, and 23.5% had no more indication to HTx because of clinical improvement. CONCLUSIONS MitraClip procedure as a bridge strategy to HTx in patients with advanced HF with significant mitral regurgitation was safe, and two thirds of patients remained free from adverse events at 1 year. These findings should be considered exploratory and hypothesis-generating to guide further study for percutaneous intervention in high-risk patients with advanced HF

Transcatheter Aortic Valve Replacement for Degenerated Transcatheter Aortic Valves: The TRANSIT International Project

Background: Transcatheter aortic valve replacement (TAVR) has determined a paradigm shift in the treatment of patients with severe aortic stenosis. However, the durability of bioprostheses is still a matter of concern, and little is known about the management of degenerated TAV. We sought to evaluate the outcomes of patients with a degenerated TAV treated by means of a second TAVR. Methods: The TRANSIT is an international registry that included cases of degenerated TAVR from 28 centers. Among around 40 000 patients treated with TAVR in the participating centers, 172 underwent a second TAVR: 57 (33%) for a mainly stenotic degenerated TAV, 97 (56%) for a mainly regurgitant TAV, and 18 (11%) for a combined degeneration. Overall, the rate of New York Heart Association class III/IV at presentation was 73.5%. Results: Valve Academic Research Consortium 2 device success rate was 79%, as a consequence of residual gradient (14%) or regurgitation (7%). At 1 month, the overall mortality rate was 2.9%, while rates of new hospitalization and New York Heart Association class III/IV were 3.6% and 7%, respectively, without significant difference across the groups. At 1 year, the overall mortality rate was 10%, while rates of new hospitalization and New York Heart Association class III/IV were 7.6% and 5.8%, respectively, without significant difference across the groups. No cases of valve thrombosis were recorded. Conclusions: Selected patients with a degenerated TAV may be safely and successfully treated by means of a second TAVR. This finding is of crucial importance for the adoption of the TAVR technology in a lower risk and younger population. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04500964

Management and Outcome of Failed Percutaneous Edge-to-Edge Mitral Valve Plasty: Insight From an International Registry.

OBJECTIVES This study evaluated the incidence, management, and outcome of patients who experienced MitraClip (Abbott Vascular) failure secondary to loss of leaflet insertion (LLI), single leaflet detachment (SLD), or embolization. BACKGROUND Transcatheter edge-to-edge repair with MitraClip is an established therapy for the treatment of mitral regurgitation (MR), but no data exist regarding the prevalence and outcome according to the mode of clip failure. METHODS Between January 2009 and December 2020, we retrospectively screened 4,294 procedures of MitraClip performed in 19 centers. LLI was defined as damage to the leaflet where the MitraClip was attached, SLD as demonstration of complete separation between the device and a single leaflet tissue, and clip embolization as loss of contact between MitraClip and both leaflets. RESULTS A total of 147 cases of MitraClip failure were detected (overall incidence = 3.5%), and these were secondary to LLI or SLD in 47 (31.9%) and 99 (67.3%) cases, respectively, whereas in 1 (0.8%) case clip embolization was observed. MitraClip failure occurred in 67 (45.5%) patients with functional MR, in 64 (43.5%) patients with degenerative MR, and 16 (10.8%) with mixed etiology. Although the majority of MitraClip failures were detected before discharge (47 intraprocedural and 42 in the hospital), up to 39.5% of cases were diagnosed at follow-up. In total, 80 (54.4%) subjects underwent a redo procedure, either percutaneously with MitraClip (n = 51, 34.7%) or surgically (n = 36, 24.5%) including 4 cases of surgical conversion of the index procedure and 7 cases of bailout surgery after unsuccessful redo MitraClip. After a median follow-up of 163 days (IQR: 22-720 days), 50 (43.9%) subjects presented moderate to severe MR, and 43 (29.3%) patients died. An up-front redo MitraClip strategy was associated with a trend toward a reduced rate of death at follow-up vs surgical or conservative management (P = 0.067), whereas postprocedural acute kidney injury, age, and moderate to severe tricuspid regurgitation were independent predictors of death. CONCLUSIONS MitraClip failure secondary to LLI and SLD is not a rare phenomenon and may occur during and also beyond hospitalization. Redo MitraClip strategy demonstrates a trend toward a reduced risk of death compared with bailout surgery and conservative management. A third of those patients remained with more than moderate MR and had substantial mortality at the intermediate-term follow-up

Prosthesis-patient mismatch following transcatheter aortic valve replacement for degenerated transcatheter aortic valves: the TRANSIT-PPM international project

Background: A severe prosthesis-patient mismatch (PPM) is associated with adverse outcomes following transcatheter aortic valve replacement (TAVR) for de novo aortic stenosis or a failed surgical bioprosthesis. The impact of severe PPM in patients undergoing TAV-in-TAVR is unknown. Aim: We sought to investigate the incidence and 1-year outcomes of different grades of PPM in patients undergoing TAV-in-TAVR. Materials and methods: The TRANSIT-PPM is an international registry, including cases of degenerated TAVR treated with a second TAVR. PPM severity, as well as in-hospital, 30-day, and 1-year outcomes were defined according to the Valve Academic Research Consortium-3 (VARC-3) criteria. Results: Among 28 centers, 155 patients were included. Severe PPM was found in 6.5% of patients, whereas moderate PPM was found in 14.2% of patients. The rate of severe PPM was higher in patients who underwent TAV-in-TAVR with a second supra-annular self-expanding (S-SE) TAVR (10%, p = 0.04). Specifically, the rate of severe PPM was significantly higher among cases of a SE TAVR implanted into a balloon-expandable (BE) device (19%, p = 0.003). At 1-year follow-up, the rate of all-cause mortality, and the rate of patients in the New York Heart Association (NYHA) class III/IV were significantly higher in the cohort of patients with severe PPM (p = 0.016 and p = 0.0001, respectively). Almost all the patients with a severe PPM after the first TAVR had a failed < 23 mm BE transcatheter heart valve (THV): the treatment with an S-SE resolved the severe PPM in the majority of the cases. Conclusion: After TAV-in-TAVR, in a fifth of the cases, a moderate or severe PPM occurred. A severe PPM is associated with an increased 1-year all-cause mortality. Clinical trial registration: [https://clinicaltrials.gov], identifier [NCT04500964]

Prosthesis-patient mismatch following transcatheter aortic valve replacement for degenerated transcatheter aortic valves: the TRANSIT-PPM international project

Background: A severe prosthesis-patient mismatch (PPM) is associated with adverse outcomes following transcatheter aortic valve replacement (TAVR) for de novo aortic stenosis or a failed surgical bioprosthesis. The impact of severe PPM in patients undergoing TAV-in-TAVR is unknown. Aim: We sought to investigate the incidence and 1-year outcomes of different grades of PPM in patients undergoing TAV-in-TAVR. Materials and methods: The TRANSIT-PPM is an international registry, including cases of degenerated TAVR treated with a second TAVR. PPM severity, as well as in-hospital, 30-day, and 1-year outcomes were defined according to the Valve Academic Research Consortium-3 (VARC-3) criteria. Results: Among 28 centers, 155 patients were included. Severe PPM was found in 6.5% of patients, whereas moderate PPM was found in 14.2% of patients. The rate of severe PPM was higher in patients who underwent TAV-in-TAVR with a second supra-annular self-expanding (S-SE) TAVR (10%, p = 0.04). Specifically, the rate of severe PPM was significantly higher among cases of a SE TAVR implanted into a balloon-expandable (BE) device (19%, p = 0.003). At 1-year follow-up, the rate of all-cause mortality, and the rate of patients in the New York Heart Association (NYHA) class III/IV were significantly higher in the cohort of patients with severe PPM (p = 0.016 and p = 0.0001, respectively). Almost all the patients with a severe PPM after the first TAVR had a failed &lt; 23 mm BE transcatheter heart valve (THV): the treatment with an S-SE resolved the severe PPM in the majority of the cases. Conclusion: After TAV-in-TAVR, in a fifth of the cases, a moderate or severe PPM occurred. A severe PPM is associated with an increased 1-year all-cause mortality

2-year outcomes of MitraClip as a bridge to heart transplantation: The international MitraBridge registry

Background: In the first report from the MitraBridge registry, MitraClip as a bridge to heart transplantation (HTx) proved to be at 1-year an effective treatment strategy for 119 patients with advanced heart failure (HF) who were potential candidates for HTx. We aimed to determine if benefits of MitraClip procedure as a bridge-to-transplant persist up to 2-years. Methods: By the end of the enrollment period, a total of 153 advanced HF patients (median age 59 years, left ventricular ejection fraction 26.9 ± 7.7%) with significant secondary mitral regurgitation, who were potential candidates for HTx and were treated with MitraClip as a bridge-to-transplant strategy, were included in the MitraBridge registry. The primary endpoint was the 2-year composite adverse events rate of all-cause death, first hospitalization for HF, urgent HTx or LVAD implantation. Results: Procedural success was achieved in 89.5% of cases. Thirty-day mortality was 0%. At 2-year, Kaplan-Meier estimates of freedom from primary endpoint was 47%. Through 24 months, the annualized rate of HF rehospitalization per patient-year was 44%. After an overall median follow-up time of 26 (9-52) months, elective HTx was successfully performed in 30 cases (21%), 19 patients (13.5%) maintained or obtained the eligibility for transplant, and 32 patients (22.5%) no longer had an indication for HTx because of significant clinical improvement. Conclusions: After 2-years of follow-up, the use of MitraClip as a bridge-to-transplant was confirmed as an effective strategy, allowing elective HTx or eligibility for transplant in one third of patients, and no more need for transplantation in 22.5% of cases