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Objectives: The aim of this study was to describe baseline characteristics, and periprocedural and mid-term outcomes of patients undergoing transcatheter mitral valve interventions post-transcatheter aortic valve replacement (TAVR) and examine their clinical benefit., Background: The optimal management of residual mitral regurgitation (MR) post-TAVR is challenging., Methods: This was an international registry of 23 TAVR centers., Results: In total, 106 of 24,178 patients (0.43%) underwent mitral interventions post-TAVR (100 staged, 6 concomitant), most commonly percutaneous edge-to-edge mitral valve repair (PMVR). The median interval post-TAVR was 164 days. Mean age was 79.5 ± 7.2 years, MR was >moderate in 97.2%, technical success was 99.1%, and 30-day device success rate was 88.7%. There were 18 periprocedural complications (16.9%) including 4 deaths. During a median follow-up of 464 days, the cumulative risk for 3-year mortality was 29.0%. MR grade and New York Heart Association (NYHA) functional class improved dramatically; at 1 year, MR was moderate or less in 90.9% of patients (mild or less in 69.1%), and 85.9% of patients were in NYHA functional class I/II. Staged PMVR was associated with lower mortality versus medical treatment (57.5% vs. 30.8%) in a propensity-matched cohort (n = 156), but this was not statistically significant (hazard ratio: 1.75; p = 0.05)., Conclusions: For patients who continue to have significant MR, remain symptomatic post-TAVR, and are anatomically suitable for transcatheter interventions, these interventions are feasible, safe, and associated with significant improvement in MR grade and NYHA functional class. These results apply mainly to PMVR. A staged PMVR strategy was associated with markedly lower mortality, but this was not statistically significant. (Transcatheter Treatment for Combined Aortic and Mitral Valve Disease. The Aortic+Mitral TRAnsCatheter Valve Registry [AMTRAC]; NCT04031274)., Competing Interests: Author Disclosures Dr. Barbanti has received consultant fees from Edwards Lifesciences. Dr. De Backer has received research grants and consultant fees from Abbott and Boston Scientific. Dr. Sievert has received institutional honoraria, travel expenses, and consulting fees from 4tech Cardio, Abbott, Ablative Solutions, Ancora Heart, Append Medical, Bavaria Medizin Technologie GmbH, Bioventrix, Boston Scientific, Carag, CardiacDimensions, Cardimed, Celonova, Comed B.V., Contego, CVRx, Dinova, Edwards Lifesciences, Endologix, Hemoteq, Hangzhou Nuomao Medtech, Holistick Medical, Lifetech, Maquet Getinge Group, Medtronic, Mokita, Occlutech, Recor, RenalGuard, Terumo, Vascular Dynamics, Vectorious Medtech, Venus, Venock, and Vivasure Medical. Dr. Grasso has been a proctor for Abbott Vascular. Dr. Andreas has been a proctor for Abbott and Edwards Lifesciences; and has received advisory board fees from Medtronic. Dr. Guerrero has received research grant support from Edwards Lifesciences. Dr. Van Mieghem has received research grant support from Abbott, Boston Scientific, Edwards Lifesciences, Medtronic, PulseCath BV, and Daiichi-Sankyo; and advisory fees from Abbott, Boston Scientific, Ancora, Medtronic, PulseCath BV, and Daiichi-Sankyo. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Introduction and Objectives: Transcatheter mitral valve repair (TMVR) with MitraClip is a therapeutic option for high surgical risk patients with severe mitral regurgitation (MR). The main objective of this study was to analyze differences in outcomes in patients with severe MR according to the cause of MR., Methods: Observational, multicenter, and prospective study with consecutive patient inclusion. The primary endpoint was the combination of all-cause mortality and new readmissions due to heart failure after 1 year. We compared clinical and procedural characteristics and the event rate for each MR group. We performed a multivariate analysis to identify predictive variables for the primary endpoint., Results: A total of 558 patients were included: 364 (65.2%) with functional etiology, 111 (19.9%) degenerative and 83 (14.9%) mixed. The mean age was 72.8±11.1 years and 70.3% of the sample were men. There were 95 (17%) events in the overall sample. No significant differences were found in the 3 groups in the number of primary outcome events: 11 (11.3%) in degenerative MR, 71 (21.3%) in functional MR, and 13 (18.1%) in mixed MR (P=.101). Independent predictors were functional class (P=.029), previous surgical revascularization (P=.031), EuroSCORE II (P=.003), diabetes mellitus (P=.037), and left ventricular ejection fraction (P=.015)., Conclusions: This study confirms the safety and efficacy of TMVR with MitraClip irrespective of MR etiology in real-life data and shows the main factors related to prognosis during the first year of follow up., (Copyright © 2019 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.)

Background: Functional mitral regurgitation (FMR) is a common finding among patients with heart failure (HF) and it is related to adverse events. Outcomes in patients undergoing transcatheter mitral valve repair (TMVR) are still a matter of debate. We performed a meta-analysis to assess mid- and long-term outcomes of patients with FMR treated with MitraClip® compared to medical management., Methods: We conducted an electronic database search of all published data PubMed Central, Embase, the Cochrane Central Register of Controlled Trials, ClinicalTrials.gov, and Google Scholar databases. The primary end-point was all-cause mortality. The secondary end-points were hospitalizations for HF, need for heart transplantation or left ventricular assist device, unplanned mitral valve surgery, myocardial infarction and stroke., Results: Five studies (n = 1513 patients) were included in the analysis. The summary estimate including all the available studies showed a statistically significant reduction in all-cause mortality favoring MitraClip® (HR 0.56, CI 95% [0.38-0.84]) and HF hospitalizations (HR 0.65; CI 95% [0.46-0.92]). A significant reduction in the indication for advanced HF therapies (OR 0.48; CI 95% [0.25-0.90]) or the need for unplanned mitral valve surgery (OR 0.20; CI 95% [0.07-0.57]) was also found in the group of patients that underwent TMVR. No differences in the incidence of myocardial infarction or stroke were found between both groups of treatment. No publication bias was detected., Conclusion: TMVR with MitraClip® system was related to a significant reduction in all-cause mortality, hospitalizations for HF and the need for HF transplant, left ventricular assist device or unplanned surgery beyond 1-year follow up., Competing Interests: Declaration of Competing Interest Dr. Estevez-Loureiro is proctor for MitraClip® and consultant for Abbott Vascular. The rest of authors have nothing to disclose., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Significant mitral regurgitation (MR) may be present in up to half of patients with heart failure (HF) and it is associated with adverse cardiac remodeling and myocardial stretch. These are potential triggers for ventricular arrhythmias (VA) in patients with HF, and therefore MR may enhance electrical ventricular vulnerability. Our aim was to evaluate VA burden before and after percutaneous mitral valve repair (PMVR) in patients with implantable cardiac devices. We conducted a prospective registry of all consecutive patients (n = 34, age 69.0 ± 12.2 years, 77% male) with significant functional mitral regurgitation (FMR) who underwent MitraClip implantation in 2 centers between June 2014 and July 2018. VA burden was defined as the total number of events during device follow-up before and after PMVR. Among patients presenting VA during follow-up before or after PMVR, device success at hospital discharge was related to a significant reduction in the incidence of Nonsustained ventricular tachycardia (VT, p = 0.002) and any sustained VT or rapid VT/ventricular fibrillation (p = 0.034). Regarding implantable cardiac defibrillator (ICD) therapies, successful PMVR was related to a reduction in incidence of either antitachycardia pacing or appropriate shocks (p = 0.045) and in the occurrence of any defibrillation shocks (p = 0.045). Overall, effective repair lead to a significant reduction in the VA burden, with a significant decrease in the occurrence of any VA (p = 0.004) and any ICD therapies (p = 0.045). In conclusion, device success after PMVR was related to a reduction in overall arrhythmic burden and ICD therapies in our cohort., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Background: Stroke recurrence despite optimal oral anticoagulation (OAC) might represent a novel indication for left atrial appendage occlusion (LAAO). The heterogeneity of these patients is generally high, as the presence of valvular atrial fibrillation (VAF) is common. The aim of this study was to explore the role of LAAO as an adjunctive therapy to OAC in patients with recurrent stroke despite optimal OAC., Methods: The study screened consecutive patients who underwent percutaneous LAAO at nine centers between 2009 and 2017. Patients with recurrent stroke despite optimal OAC were selected and those with an absolute or relative contraindication to OAC were not included in the study., Results: Among 837 patients who underwent LAAO between the study period, a total of 22 (2.6%) met the inclusion criteria. There was a high percentage of VAF (38%) and 59% presented more than one cardioembolic event before LAAO. All patients underwent successful implantation of the device and no procedural major adverse events were reported. In all but 3 patients, anticoagulation was continued after LAAO. With a median clinical follow-up of 1.8 years (range, 0.7-2.8 years), only 1 stroke and 1 transient ischemic attack were reported, translating into a significant reduction of cerebrovascular events before and after LAAO (2.0 ± 1.0 events vs 0.1 ± 0.3 events; P<.01). Imaging follow-up revealed only 1 case of device thrombosis., Conclusions: LAAO as an adjunctive therapy to OAC seems to be feasible and safe in patients with previous cardioembolic events despite optimal OAC. In our series, this strategy was associated with a low rate of cerebrovascular events after LAAO.

Objectives: The aim of this study was to compare transcatheter aortic valve replacement (TAVR) with the Acurate neo (NEO) and Evolut PRO (PRO) devices., Background: The NEO and PRO bioprostheses are 2 next-generation self-expanding devices developed for TAVR., Methods: The NEOPRO (A Multicenter Comparison of Acurate NEO Versus Evolut PRO Transcatheter Heart Valves) registry retrospectively included patients who underwent transfemoral TAVR with either NEO or PRO valves at 24 centers between January 2012 and March 2018. One-to-one propensity score matching resulted in 251 pairs. Pre-discharge and 30-day Valve Academic Research Consortium (VARC)-2 defined outcomes were evaluated. Binary logistic regression was performed to adjust the treatment effect for propensity score quintiles., Results: A total of 1,551 patients (n = 1,263 NEO; n = 288 PRO) were included. The mean age was 82 years, and the mean Society of Thoracic Surgeons score was 5.1%. After propensity score matching (n = 502), VARC-2 device success (90.6% vs. 91.6%; p = 0.751) and pre-discharge moderate to severe (II+) paravalvular aortic regurgitation (7.3% vs. 5.7%; p = 0.584) were comparable between the NEO and PRO groups. Furthermore, there were no significant differences in any 30-day clinical outcome between matched NEO and PRO pairs, including all-cause mortality (3.2% vs. 1.2%; p = 0.221), stroke (2.4% vs. 2.8%; p = 1.000), new permanent pacemaker implantation (11.0% vs. 12.8%; p = 0.565), and VARC-2 early safety endpoint (10.6% vs. 10.4%; p = 1.000). Logistic regression on the unmatched cohort confirmed a similar risk of VARC-2 device success, paravalvular aortic regurgitation II+, and 30-day clinical outcomes after NEO and PRO implantation., Conclusions: In this multicenter registry, transfemoral TAVR with the NEO and PRO bioprostheses was associated with high device success, acceptable rates of paravalvular aortic regurgitation II+, and good 30-day clinical outcomes. After adjusting for potential confounders, short-term outcomes were similar between the devices., (Copyright © 2019. Published by Elsevier Inc.)

LAA closure and MitraClip implantation in the tricuspid position in the same procedure is a feasible and safe option in patients with a high surgical risk suffering from severe symptomatic tricuspid regurgitation and bleeding complications under anticoagulant therapy.

Objectives: MitraClip is an established therapy for patients with mitral regurgitation (MR) that are considered of high-risk or inoperable. However, late bleeding events (BE) after hospital discharge and their impact on prognosis in this cohort of patients have been poorly investigated. Our purpose is to address the incidence, related factors and clinical implications of BE after hospital discharge in patients treated with MitraClip., Methods: Prospective registry of all consecutive patients (n = 80) who underwent MitraClip implantation in our Institution between June 2014 and December 2017. BE were defined according to MVARC definitions. A combined clinical end-point including admission for heart failure (HF) and all-cause mortality was established to analyze prognostic implications of BE., Results: During a median follow up of 523.5 days, 41 BE were reported in 21 patients. Atrial fibrillation (AF, HR 4.54, CI95% 1.20-17.10) and combined antithrombotic therapy at discharge (HR 3.52, CI95% 1.03-11.34) were independently associated with BE. In the study period, 15 (18.8%) patients died, 20 (25%) were admitted for HF and 29 (36.3%) presented the combined end-point. After multivariable adjustment BE remained independently associated with an adverse outcome (HR 3.80, CI 95% 1.66-8.72). In the subgroup of patients with AF, HAS-BLED score was higher among subjects with BE (3.1 ± 1.3 vs 2.1 ± 0.9, p = 0.003). HAS-BLED score had a significant discrimination power for the occurrence BE (AUC: 0.677 [0.507-0.848]) in this subgroup., Conclusions: BE are common after MitraClip and are associated with an impaired outcome. Strategies to reduce bleeding events are paramount in this cohort of patients.

Introduction and Objectives: New drug-eluting stents (DES) designed to overcome the limitations of existing devices should initially be tested in preclinical studies. Our objective was to analyze the safety and efficacy of new biodegradable polymer-based DES compared with bare-metal stents (BMS) and commercially available DES in a model of normal porcine coronary arteries., Methods: We randomly implanted 101 stents (BMS and biodegradable polymer-based sirolimus-eluting stents: 3 test stent iterations [BD1, BD2, and BD3], Orsiro, Biomime and Biomatrix) in the coronary arteries of 34 domestic pigs. Angiographic and histomorphometric studies were conducted 1 month (n = 83) and 3 months (n = 18) later., Results: The stents were implanted at a stent/artery ratio of 1.31 ± 0.21, with no significant differences between groups. At 1 month, the new test stents (BD1, BD2 and BD3) showed less late loss and angiographic restenosis, as well as lower histologic restenosis and neointimal area (P < .0005), than the BMS. There were no differences in endothelialization, vascular injury, or inflammation between the new test stents and BMS, although the new stents showed higher fibrin deposition (P = .0006). At 3 months, all these differences disappeared, except for a lower neointimal area with the new BD1 stent (P = .027). No differences at any time point were observed between the new test stents and commercially available controls., Conclusions: In this preclinical model, the new biodegradable polymer-based DES studied showed less restenosis than BMS and no significant differences in safety or efficacy vs commercially available DES., (Copyright © 2017 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.)

Background: The MitraClip® system is a percutaneous treatment for mitral regurgitation (MR) that has shown promising results in patients who are inoperable or at high risk for mitral surgery. Data on the efficacy of the system over optimal medical therapy, above all in patients with functional MR, are scarce. The study aim was to assess the effect of MitraClip on the survival of patients with moderate/severe or severe MR compared to medical therapy, using meta-analytical techniques., Methods: Independently, reviewers searched electronically for relevant articles based on predefined criteria and end-points. Only articles with a comparison between MitraClip and conservative therapy were included. Standard meta-analysis techniques were used. The primary outcomes were 30-day and one-year mortalities., Results: Five observational reports were included that enrolled a total of 1,271 patients: 720 patients underwent percutaneous mitral valve repair (PMVR) with the MitraClip device, and 551 were managed conservatively. A total of 49 all-cause mortality events was reported at 30 days: 3.05% (22/720) in the PMVR arm, and 4.90% (27/510) in the conservative group, with no significant differences in all-cause mortality (OR 0.64; 95% CI 0.36-1.14). A total of 269 all-cause mortality events at one year was reported: 15.14% (109/720) in the PMVR arm, and 29.04% (160/551) in the conservative group. A significant difference favoring PMVR with the MitraClip system over medical therapy alone was observed (OR 0.44; 95% CI 0.30-0.64, p <0.0001). Neither significance between study heterogeneity (p = 0.18) nor publication bias was detected (p = 0.3)., Conclusions: PMVR with the MitraClip system may be associated with an improvement in one-year survival compared to stand-alone medical management.

A 79-year-old woman with a history of ischemic dilated cardiomyopathy, severely depressed left ventricular ejection fraction and significant mitral regurgitation (MR) was admitted to the authors´ institution for percutaneous mitral valve repair. Transesophageal echocardiography (TEE) revealed the presence of a posterior mitral cleft at the P2 level, causing a trileaflet mitral valve that contributed significantly to the regurgitant jet. The procedure was performed under general anesthesia and guided by real-time three-dimensional TEE. Three MitraClip® devices (Abbott Vascular, Santa Clara, CA, USA) were implanted, which reduced the MR to grade 1+.

Background: Atrial fibrillation is present in 30-50% of patients undergoing percutaneous mitral valve repair. The presence of a formal contraindication to oral anticoagulation is also very common in these patients. In this context, percutaneous left atrial appendage occlusion (LAAO) may be a valid alternative for these patients. The study aim was to assess the feasibility, safety, and technical considerations of the combination of percutaneous mitral valve repair using the MitraClip system and LAAO. The present study describes the multicenter experience of combined MitraClip and LAAO procedures., Methods: Between April 2012 and April 2016, six patients were successfully treated with the combined procedure., Results: In all patients, mitral valve repair was performed before LAAO. Both procedures were successfully performed in all cases without any relevant procedural complication or mortality., Conclusions: According to the results of the present study, a combination of both techniques appears to be feasible and safe, with favorable in-hospital outcomes.

A 59-year-old male with a history of mitral valve replacement several years previously was admitted to the authors' institution with symptoms of advanced heart failure. Echocardiography showed a severe paravalvular dehiscence and surgery was discouraged due to high perioperative risk. A first transcatheter leak closure was unsuccessful despite the correct deployment of various occluding devices. A second percutaneous attempt was carried out with implantation of three Amplatzer Vascular Plug® III devices (five occluders were positioned in total within the oblong defect), leading to a mild residual leakage. Device embolism occurred twice during the procedure but was resolved using adequate catheter retrieval techniques.

Unlabelled: The long-term results of cryomaze in patients with longstanding persistent atrial fibrillation during concomitant surgical procedures are still uncertain., Methods: Between 2006 and 2011, 150 consecutive patients with associated long-lasting permanent atrial fibrillation and associated heart disease underwent heart surgery were treated by biatrial Cox-Maze (63 patients) or by isolated endocardial or epicardial left atrial cryoablation (83 patients) concomitantly. The results at 3 years in these groups were compared with clinical monitoring, electrocardiography, 24-hour Holter, and echocardiography with measurement of the transmitral A wave at 1, 6 and 12 months and annually thereafter in all patients., Results: Patients undergoing Cox-Maze IV ablation presented rates of freedom from atrial fibrillation of 97, 94, 89, 80 and 54% at 1, 6, 12, 24 and 36 months, respectively. In the 12-month follow-up, these differences were significant (p<.05). The independent risk factors of atrial fibrillation recurrence was isolated ablation of left atrium., Conclusions: Atrial fibrillation by cryothermia ablation had a high success rate before 2 years postoperatively. Recurrence of atrial fibrillation increased thereafter regardless of the technique used, although it was more intense and developed earlier in cases of monoatrial ablation. For the treatment of other long-lasting permanent atrial fibrillation cardiac surgery-associated pathology, an aggressive biatrial treatment with Cox maze ablation should be performed., (Copyright © 2015 Instituto Nacional de Cardiología Ignacio Chávez. Published by Masson Doyma México S.A. All rights reserved.)

MitraClip (Abbott Vascular) therapy has been reported to be a safe and effective treatment for mitral regurgitation, even when the commissures are targeted. However, complications during the procedure may occur. We present a 44-year-old patient who underwent MitraClip implantation complicated by chordal rupture, resulting in emergent mitral valve replacement.

An 83-year-old high-risk gentleman diagnosed with severe symptomatic aortic stenosis was scheduled for TAVR. A 31 mm CoreValve was implanted but severe paravalvular leak was noted. A valve-in-valve procedure was performed. However, the valve frame was partially dislodged into de ascending aorta. We report our strategy to solve this severe leak after a failed valve-in-valve procedure.

Significant periprosthetic aortic regurgitation after transcatheter aortic valve implantation with Edwards SAPIEN prosthesis has become a major concern of this technique given its association with impaired survival. We report the successful closure of such defects using vascular occlusion devices with significant improvement in clinical status of patients.