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Objectives: The aim of this study was to investigate the adverse impact of elevated postprocedural mitral valve pressure gradient (MPG) on outcome in a real-world population of patients with severe mitral regurgitation (MR) who underwent transcatheter mitral valve edge-to-edge repair (TEER)., Background: TEER has become a routine treatment alternative for patients with severe MR at high surgical risk. The consequences of elevated MPG after TEER have been subject to controversial debates., Methods: All consecutive patients undergoing TEER for either severe degenerative MR (DMR) or functional MR (FMR) at a high-volume center between September 2008 and January 2020 were prospectively included and followed periodically. Postprocedural MPG by discharge transthoracic echocardiography was considered elevated at ≥5 mm Hg. The primary combined endpoint was death or heart failure rehospitalization after 5 years., Results: A total of 713 patients undergoing TEER (DMR, n = 265; FMR, n = 445) were included. Elevated postprocedural MPG was present in 37.0% of those with DMR (n = 98) and 22.0% of those with FMR (n = 98). In contrast to patients with FMR, 6-minute walk distance did not improve in patients with DMR with elevated MPG. Kaplan-Meier analyses did not demonstrate significant differences for the primary endpoint in patients with DMR (low vs elevated MPG, 67.3% vs 74.4%; P = 0.06) and those with FMR (78.6% vs 74.8%; P = 0.54). After adjustment, elevated MPG was an independent predictor of the primary endpoint in patients with DMR (HR: 1.59; 95% CI: 1.03-2.45; P = 0.034) but not in those with FMR (HR: 0.87; 95% CI: 0.63-1.22; P = 0.43)., Conclusions: Elevated postprocedural MPG is an independent predictor of adverse clinical and functional outcomes in patients with DMR but not in those with FMR., Competing Interests: Funding Support and Author Disclosures Dr Ludwig has received travel expenses from Edwards Lifesciences. Dr Schofer has received nonfinancial support from Abbott and Edwards Lifesciences. Dr Blankenberg has received grants and personal fees from Abbott. Dr Conradi has received personal fees from Edwards Lifesciences; and is a proctor and consultant for Abbott. Dr Lubos has received speaker honoraria, travel expenses, and research grants from Abbott. Dr Kalbacher has received speaker honoraria from Abbott; and has received travel expenses and proctor fees from Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: Due to high rates of transcatheter mitral valve replacement (TMVR) screening failure, a substantial proportion of patients with severe mitral regurgitation (MR) remains on optimal medical treatment (OMT) only. Data on outcomes of these patients ineligible for mitral interventions are scarce. This study aimed to assess characteristics and outcomes of severe MR patients treated medically following TMVR screening failure., Methods: From 2016-2020, a total of 111 patients with severe MR underwent screening for TMVR. Screening failure occurred in 66 cases. Among these, 30 patients were treated with OMT only. Characteristics of these patients were analyzed, Kaplan-Meier estimates calculated, and univariate regression analysis performed. Median follow-up time was 2.26 years (95% confidence interval, 1.24-3.25)., Results: Anatomical reasons for screening failure in the study cohort (n = 30) were left ventricular (LV) restraints, risk of LV outflow tract obstruction, mitral annulus calcification, and sizing issues. Median ejection fraction was 56.0% (interquartile range, 38.8%-60.0%). Concomitant tricuspid regurgitation and severe pulmonary hypertension were present in 36.7% and 46.2%, respectively. Intercommissural diameters ranged from 22.5-52.0 mm. Mortality was 23.6% after 6 months and 35.7% after 1 year. Factors associated with mortality were female sex, MR severity, ischemic MR, high N-terminal pro-brain natriuretic peptide levels, and small annulus diameters., Conclusions: Despite growing experience with TMVR, the subset of MR patients anatomically eligible for TMVR is small and many patients are treated medically. Mortality in these patients remains high, underlining an unmet need for adequate therapeutic alternatives. TMVR devices adapting to broader annular size ranges with smaller ventricular profiles might fill this gap.

Aims: Transcatheter mitral valve replacement (TMVR) with dedicated devices promises to fill the treatment gap between open-heart surgery and edge-to-edge repair for patients with severe mitral regurgitation (MR). We herein present a single-centre experience of a TMVR series with two transapical devices., Methods and Results: A total of 11 patients were treated with the Tendyne™ (N = 7) or the Tiara™ TMVR systems (N = 4) from 2016 to 2020 either as compassionate-use procedures or as commercial implants. Clinical and echocardiographic data were collected at baseline, discharge and follow-up and are presented in accordance with the Mitral Valve Academic Research Consortium (MVARC) definitions. The study cohort [age 77 years (73, 84); 27.3% male] presented with primary (N = 4), secondary (N = 5) or mixed (N = 2) MR etiology. Patients were symptomatic (all NYHA III/IV) and at high surgical risk [logEuroSCORE II 8.1% (4.0, 17.4)]. Rates of impaired RV function (72.7%), severe pulmonary hypertension (27.3%), moderate or severe tricuspid regurgitation (63.6%) and prior aortic valve replacement (63.6%) were high. Severe mitral annulus calcification was present in two patients. Technical success was achieved in all patients. In 90.9% (N = 10) MR was completely eliminated (i.e. no or trace MR). Procedural and 30-day mortality were 0.0%. At follow-up NYHA class was I/II in the majority of patients. Overall mortality after 3 and 6 months was 10.0% and 22.2%., Conclusions: TMVR was performed successfully in these selected patients with complete elimination of MR in the majority of patients. Short-term mortality was low and most patients experienced persisting functional improvement.

Aims: MitraClip therapy for the treatment of functional mitral regurgitation (FMR) is an increasingly used intervention for high-risk surgical patients. The aim of this observational study was to assess the impact of residual mitral regurgitation (rMR) at discharge on long-term outcome after MitraClip therapy in patients with FMR., Methods and Results: Overall, 458 patients (mean age 73.8 ± 8.9 years) underwent MitraClip implantation between September 2008 and December 2017. The impact of rMR ≤ 1+ at discharge (n = 251) was retrospectively compared to patients graded as rMR 2+ (n = 173) and rMR ≥3+ (n = 34) at discharge. Median follow-up time was 5.09 years (5.00-5.26) with maximum follow-up of 10.02 years. The primary outcome was survival, and Kaplan-Meier analyses revealed significant differences among all rMR subgroups with highest survival rates for rMR ≤ 1+ patients. This was further confirmed by composite outcome analyses (P < 0.02). The inferior outcomes of rMR 2+ and rMR ≥ 3+ at discharge were confirmed by increased adjusted hazard ratios when rMR 2+ (1.54, P = 0.0039) and rMR ≥ 3+ (2.16, P = 0.011) were compared to rMR ≤ 1+. Moreover, patients with stable rMR ≤ 1+ grades within 12 months showed significantly higher survival rates compared to patients with rMR ≤ 1+ at discharge and rMR ≥ 2+ at 12-month follow-up or rMR ≥ 2+ at discharge and 12-month follow-up (P = 0.029)., Conclusions: Patients with optimal and durable rMR ≤ 1+ at discharge and 12-month follow-up showed better outcome compared to patients with rMR 2+ and rMR ≥ 3+. Treatment success and durability characterized by rMR ≤ 1+ at discharge and 12 months seem to be important factors for long-term outcomes, which has to be further confirmed by prospective randomized trials., (© 2020 European Society of Cardiology.)

Percutaneous placement of transcatheter heart valves for treatment of degenerated surgical valves in the aortic and mitral position is an emerging therapy for selected high-risk patients. Here we describe in detail the first case in the literature of a patient (female, 72 years old, log EuroSCORE 22.9%) with a degenerated biological mitral prosthesis which was successfully treated by transapical implantation of a Lotus valve. The case described demonstrates the very controlled feasibility of valve-in-valve treatment for a degenerated mitral bioprosthesis with a mechanically expanding Lotus valve.

Background: Analyses emphasizing gender-related differences in acute and long-term outcomes following MitraClip therapy for significant mitral regurgitation (MR) are rare., Methods: 592 consecutive patients (75 ± 8.7 years, 362 men, 230 women) underwent clinical and echocardiographic follow-up for a median of 2.13 (0.99-4.02) years., Results: Significantly higher prevalence of cardiovascular comorbidities, renal failure, and adverse echocardiographic parameters in men resulted in longer device time (p = 0.007) and higher numbers of implanted clips (p = 0.0075), with equal procedural success (p = 1.0). Rehospitalization for heart failure did not differ (p[logrank] = 0.288) while survival was higher in women (p[logrank] = 0.0317). Logarithmic increase of NT-proBNP was a common independent predictor of death. Hypercholesterolemia and peripheral artery disease were predictors of death only in men while ischemic and dilative cardiomyopathy (CM) and age were predictors in women. Independent predictors of rehospitalization for heart failure were severely reduced ejection fraction and success in men while both ischemic and dilative CM, logistic EuroSCORE, and MR severity were predictive in women., Conclusions: Higher numbers of implanted clips and longer device time are likely related to more comorbidities in men. Procedural success and acute and mid-term clinical outcomes were equal. Superior survival for women in long-term analysis is presumably attributable to a comparatively better preprocedural health.

Introduction: Implantation of transcatheter heart valves (THV) into degenerated surgical valves is an emerging therapy for selected high-risk patients. Although, CE mark of most THV is limited for native aortic valvular stenosis, transcatheter valve implantation into degenerated bioprostheses, even in mitral position is very intriguing., Methods and Results: After placement of a cerebral protection device (Claret Sentinel®), three consecutive patients (age, 79.0 ± 6.1; log EuroSCORE I: 33.3 ± 9.2%) with a degenerated mitral bioprosthesis were treated by transapical implantation of the Lotus® valve (Boston Scientific Inc.). In addition, a SwanGanz catheter was introduced in the pulmonary artery for hemodynamic assessments all patients. Procedural success was 100%. Valve implantation was performed without rapid ventricular pacing. Resheating was performed in two patients due to suboptimal initial positioning. Invasive online hemodynamics revealed stable blood pressure in all patients. After Lotus® valve implantation, valvular mitral regurgitation was completely eliminated in all patients. One patient had a mild paravalvular leak of the surgical bioprosthesis, which was present before implantation. Invasive right and left heart hemodynamics showed an immediate improvement after Lotus® valve implantation. Mean mitral surface area (2.1 ± 0.2 cm(2) ) and mean gradient (3.7 ± 2.1 mm Hg) demonstrated satisfactory results. All patients were immediately extubated and discharged from the hospital without any adverse event., Conclusions: This study demonstrates for the first time the feasibility of transapical Lotus® Valve implantation in degenerated mitral bioprostheses. The controlled mechanical Lotus® valve expansion with remarkably stable hemodynamics throughout the procedure offers a new and valuable treatment option., (© 2015 Wiley Periodicals, Inc.)

Aims: Parachute® implantation (PI) is an attractive treatment option for patients with left ventricular apical aneurysms (LVAA). So far, only the retrograde approach has been approved for PI. Unfortunately, severe functional mitral regurgitation (MR) restricts PI. Thus, we were intrigued to combine PI and MitraClip therapy (MCT) as a new transvenous hybrid concept., Methods and Results: PI was performed via a transseptally placed MitraClip guide in six consecutive patients (age 73.8±5.2; 66% male). Immediately after PI, MR was treated by MCT. Invasive right and left heart haemodynamics were taken before and after PI and MCT, respectively. Procedural success was 100%. PI induced a numerical increase in cardiac output (CO: +36.4; p=0.15) and stroke volume (SV: +30.1%; p=0.09), despite some evidence of MR aggravation. Subsequent MCT successfully reduced MR at least to mild in five patients and to moderate in one patient. SV and CO demonstrated a further increase (SV: +44.3%, p=0.03; CO: +44.5%; p=0.03)., Conclusions: The study documents for the first time the feasibility of transseptal and transmitral PI. Nevertheless, pre-procedural MR seems to counteract the beneficial effects of PI. Hence, the combined transseptal approach of PI and MCT seems to be the appropriate strategy in patients with significant MR and LVAA.

Objectives: The aim of the study was to assess predictors of acute procedural failure in surgical high-risk patients undergoing MitraClip (Abbott Vascular, Abbott Park, Illinois) therapy., Background: MitraClip implantation is a novel percutaneous option to treat significant mitral regurgitation (MR)., Methods: In 300 patients (75 ± 9 years of age, 190 [63%] men), of whom 32 (10.7%) had been unsuccessfully treated (discharge MR grade of >2+), baseline clinical and echocardiographic variables were evaluated by exact logistic regression and classification tree analyses to assess their impact on acute procedural failure. Acute procedural failure was differentiated into aborted procedure (no MitraClip implanted; n = 11) and "clip failure" (inadequate MR reduction despite MitraClip implantation; n = 21)., Results: Multivariate logistic regression identified effective regurgitant orifice area (EROA), mitral valve orifice area (MVOA), and mean transmitral pressure gradient (TMPG) as independent predictors of overall acute procedural failure. Classification tree analysis revealed that an EROA >70.8 mm(2) (n = 28) was associated with a high rate (25%) of clip failures, whereas the combination of an MVOA ≤3.0 cm(2) and a TMPG ≥4 mm Hg (n = 16) was associated with a high rate (37.5%) of aborted procedures. Failure rates of ≤10% were observed in all patients with an EROA ≤70.8 mm(2) and either an MVOA >3.0 cm(2) (n = 217) or an MVOA ≤3.0 cm(2) in concert with a TMPG ≤3 mm Hg (n = 39). Multinomial logistic regression identified an EROA >70.8 mm(2) and a TMPG ≥4 mm Hg as independently predictive of clip failure, but an MVOA ≤3.0 cm(2) and a TMPG ≥4 mm Hg as independently predictive of procedure abortion., Conclusions: In surgical high-risk patients undergoing MitraClip therapy, a TMPG ≥4 mm Hg, an EROA ≥70.8 mm(2), and an MVOA ≤3.0 cm(2) carry an increased risk of procedural failure., (Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: In inoperable or high-surgical-risk patients, transcatheter aortic valve replacement (TAVR) and repair of the mitral valve using the MitraClip have emerged as novel treatment strategies. We sought to assess the feasibility and effectiveness of bivalvular transcatheter therapy in patients with coexisting aortic stenosis and mitral regurgitation., Methods: Out of 285 patients treated with TAVR and 226 patients who underwent MitraClip therapy at our institution, 11 patients (78 ± 6years, 9 men [82%]) received both therapies. TAVR preceded MitraClip therapy in 10 patients, with 3 patients undergoing both interventions in a single session., Results: TAVR via transapical (n = 6) or transfemoral (n = 5) access utilized the Sapien/Sapien XT and CoreValve prostheses in 7 and 4 patients, respectively. All TAVR procedures were successful, with significant increases in effective aortic orifice area and decreases in mean transvalvular pressure gradient. MitraClip therapy succeeded in reducing MR severity to <2+ in 10 patients. Periprocedurally, 1 patient sustained a stroke. At a median of 208 days, 2 patients were in NYHA functional class II, with only 1 patient improved from before TAVR, and 6 patients were in class III (improvement in 1). Four patients had died at a median of 60 days after MitraClip therapy., Conclusion: Bivalvular transcatheter treatment of patients with coexisting aortic stenosis and MR is technically feasible, even in a single session. Given the low prevalence of midterm functional improvement, factors predictive of clinical benefit from catheter-based double-valve intervention remain to be determined., (Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.)

For elderly patients with relevant comorbidities, combined cardiac surgery may be inadequate due to excessive surgical risk. Combining interventional valvular and surgical approaches may decrease surgical burden and operative risk. In the present case, we report a staged strategy of interventional mitral valve repair and secondary surgical aortic valve replacement and replacement of the ascending aorta in a patient at high risk for surgery. This hybrid approach allowed for substitution of one part of surgery by the relatively low-risk MitraClip procedure. For the future, increasing clinical importance of interventional valve therapies either for stand-alone or hybrid procedures can be anticipated., (Georg Thieme Verlag KG Stuttgart · New York.)

Aims: To assess, and identify predictors of 2-year adverse outcomes of surgical high-risk patients after successful MitraClip therapy (MC), differentiated by the aetiology of mitral regurgitation (MR)., Methods and Results: Kaplan-Meier analysis was used to assess survival free from death, heart failure rehospitalization, and reintervention up to 2 years in 202 successfully treated patients [74 ± 9 years, 132 men (65%); secondary MR aetiology in 140 patients, primary MR in 62]. Predictors for study endpoints were determined using Cox regression analyses. Mortality was 20% at 1 year and 33% at 2 years in both primary and secondary MR patients; independent predictors of death were reduced forward stroke volume, impaired LV function, and renal failure in primary MR, yet only an increased logistic EuroSCORE in functional MR patients. The rate of rehospitalizations was not different between the patient subgroups for 6 months, but then diverged significantly in favour of primary MR patients (estimated 2-year incidence, primary MR 40% vs. secondary MR 66%). No predictor was found for primary MR patients, but increased LV end-diastolic volume significantly increased the risk of rehospitalization in functional MR patients. Reinterventions were overall rare (7.4% at 1 year, 9.7% at 2 years); primary MR patients required all except one reintervention within 2 months of MC, with again no predictors found, whereas secondary MR patients (all except one with discharge MR of 2+) exhibited a steadily declining freedom from reintervention curve throughout follow-up., Conclusion: MR aetiology affects rehospitalization and reintervention, but not mortality, differently after successful MC.

Objective: Surgical mitral valve repair carries an elevated perioperative risk in the presence of severely reduced ventricular function and relevant comorbidities. We sought to assess the feasibility of catheter-based mitral valve repair using a clip-based percutaneous edge-to-edge repair system in selected patients at high surgical risk with mitral regurgitation grade 3 or worse., Methods: Between 2002 and January 2011, 202 consecutive patients without prior mitral valve surgery (age 75 ± 9 years; 63% were male) with symptomatic functional (65%), degenerative (27%), or mixed (8%) mitral regurgitation were treated with a percutaneous clip system for approximation of the anterior and posterior mitral leaflets. Risk for mitral valve surgery was considered high in terms of a mean logistic European System for Cardiac Operative Risk Evaluation of 44% (range, 21%-54%). Preprocedural left ventricular ejection fraction was 35% or less in 36% of patients. An interdisciplinary heart team of cardiologists and cardiac surgeons discussed all patients., Results: Percutaneous clip implantation was successful in 186 patients (92%). Patients were treated with 1 clip (n = 125; 62%), 2 clips (n = 64; 32%), or 3 or more clips (n = 7; 3%). Reduction in mitral regurgitation from pre- to postprocedure was significant (P < .0001) and remained stable within the first 12 months in the majority of patients. Thirty-day mortality was 3.5% (7/202 patients). Hospital stay was 12 ± 10 days, and median intensive care unit stay was 1 day (range, 0-45 days). Eleven patients required surgical valve repair/replacement at a median of 38 days (0-468 days) after percutaneous clip implantation., Conclusions: Clip-based percutaneous mitral valve repair is a safe, low-risk, and effective therapeutic option in symptomatic patients with a high risk for surgery and does not exclude later surgical repair., (Copyright © 2012 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.)

Objective: Conventional or minimally invasive surgical mitral valve repair (MVR) is the gold-standard treatment for severe mitral regurgitation (MR) of any etiology. Given its good safety profile, trans-catheter MVR with the MitraClip™ device is used increasingly for high-risk or inoperable patients. We report our experience with failed MitraClip™ therapy and its impact on subsequent surgical strategies, such as the feasibility of MVR in high-risk patients., Methods: During a follow-up of 344 ± 227 days from the first 215 consecutive patients treated with the MitraClip™ device, six patients required surgical re-intervention due to failed repair (n = 3) or recurrent severe MR (n = 3) at 35.8 ± 47.7 (range 0-117) days after trans-catheter MVR. Feasibility of secondary surgical MVR was assessed with regard to prior clip therapy., Results: In three patients, secondary surgical MVR was successfully performed following the surgical strategy deemed optimal before trans-catheter treatment. Injury of the mitral leaflets caused by prior clip treatment was present in three other patients and influenced the surgical strategy toward more complex surgical techniques in one case and MV replacement in two others. One patient died 6 days after MV replacement. All other patients are alive with adequate valve function at the latest follow-up of 12.4 ± 7.4 months (range 4-22)., Conclusions: Secondary surgical MVR was feasible in some patients after prior clip treatment, but led to valve replacement in others. At present, patient selection criteria for trans-catheter MVR should not be expanded toward more healthy patients, as primary trans-catheter MVR may complicate secondary surgery in certain cases and may even preclude reconstructive valve surgery., (Copyright © 2011 European Association for Cardio-Thoracic Surgery. Published by Elsevier B.V. All rights reserved.)

Objectives: The aim of this study was to assess the outcomes of patients at prohibitive surgical risk undergoing MitraClip therapy (Abbott Vascular, Redwood City, California) for severe mitral regurgitation (MR)., Background: The safety of percutaneous mitral valve repair has been documented. However, midterm development of mitral valve function, ventricular remodeling, and clinical outcomes in patients not amenable to surgery are unknown., Methods: A total of 104 consecutive patients (mean age 74 ± 9 years; 64 men; 49 and 54 with MR 3+ and 4+, respectively; 69 with functional MR; 59 and 45 in New York Heart Association classes III and IV, respectively) were followed for a median of 359 days., Results: Device success was achieved in 96 patients (92%). In patients with successful index procedures, MR grade ≤2+ was present at follow-up in 82.5%, left ventricular end-diastolic and -systolic volumes were reduced, and forward stroke volumes were significantly increased. Improvements in New York Heart Association functional class were observed in 80% of patients, with 69% in class I or II; 75% improved in the 6-min walk test; and 74% reported improvements in quality of life. One-year estimates of mortality and rehospitalization were 22% and 31%, respectively. Forward stroke volume at discharge emerged as a predictor of event-free survival., Conclusions: MitraClip therapy improves clinical and echocardiographic outcomes at 1 year in about three-quarters of critically ill, elderly patients with moderate to severe MR not amenable to surgery., (Copyright © 2011 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)