Safety and Effectiveness of Concomitant Mitral Transcatheter Edge-to-Edge Repair and Left Atrial Appendage Closure.

BACKGROUND: Concomitant mitral transcatheter edge-to-edge repair (M-TEER) and left atrial appendage closure (LAAC) showed to be a feasible approach to optimize the treatment of patients eligible for both procedures, but mid-term outcomes are unclear. METHODS: We retrospectively analyzed consecutive patients undergoing M-TEER and enrolled in the local prospective Getting Reduction of Mitral Insufficiency by Percutaneous Clip Implantation (GRASP) registry. We compared patients undergoing isolated M-TEER (n = 58, 58.5%) with those undergoing concomitant M-TEER and LAAC (n = 41, 41.5%) from January 2018 to December 2022. The primary endpoint was a composite of all-cause death, stroke or systemic embolism, hospitalization for heart failure, and bleeding at 1 year. The co-primary endpoint was procedural success. RESULTS: The primary endpoint was similar between patients undergoing concomitant M-TEER+LAAC or isolated M-TEER (Kaplan Meier (KM) estimates 36.6% vs. 44.8%; plog-rank = 0.75). Procedural success was also similar (92.7% vs. 94.8%; p = 0.69). At 1- year, minor bleeds were lower in patients undergoing concomitant M-TEER and LAAC (KM estimates 0.0% vs. 18.9%; plog-rank < 0.01). CONCLUSION: In patients with concomitant MR and AF and eligible for M-TEER and LAAC treatment, a combined approach of M-TEER and LAAC was as safe as an M-TEER-alone strategy and associated with lower minor bleeding at 1 year.

Impact of Post-Procedural Change in Left Ventricle Systolic Function on Survival after Percutaneous Edge-to-Edge Mitral Valve Repair.

OBJECTIVES: To investigate how the changes of left ventricle ejection fraction (LVEF) between admission and discharge affected the long-term outcome in patients who underwent percutaneous edge-to-edge mitral valve repair for secondary mitral regurgitation. BACKGROUND: An acute impairment of LVEF after surgical repair of mitral regurgitation, known as afterload mismatch, has been associated with increased all-cause mortality. Afterload mismatch after percutaneous edge-to-edge mitral valve repair has been postulated to be a transient phenomenon. METHODS: This study is based on a single-center, retrospective, observational registry of patients who underwent percutaneous edge-to-edge mitral valve repair with the MitraClip (Abbot Vascular) system for the treatment of symptomatic, moderate-to-severe mitral regurgitation. We included data on 399 patients who underwent percutaneous edge-to-edge mitral valve repair for secondary mitral regurgitation. Expert echocardiographers assessed LVEF before the procedure and at discharge. The patients were divided into three groups according to the difference of periprocedural LVEF measurements: unchanged (n = 318), improved (n = 40), and decreased (n = 41) LVEF. RESULTS: The median follow-up time was 2.0 years. When adjusted for gender, NYHA class and estimated glomerular filtration rate, decreased postprocedural LVEF was associated with an increased risk of death (adjusted HR 2.05, 95% CI 1.26-3.34) and increased postprocedural LVEF with a reduced risk of death (adjusted HR 0.47, 95% CI 0.24-0.91) compared to unchanged LVEF. Conclusion: Among patients who underwent percutaneous edge-to-edge mitral valve repair, decreased postprocedural LVEF was associated with increased mortality, while improved LVEF was associated with lower mortality compared to unchanged LVEF.

Incidence, Timing, Causes and Predictors of Early and Late Re-Hospitalization in Patients Who Underwent Percutaneous Mitral Valve Repair With the MitraClip System.

The pattern and reasons for re-hospitalization (RH) after MitraClip implantation are not well characterized. A total of 322 consecutive MitraClip patients were included, with data stratified by RH status. Multivariate analyses were conducted to identify predictors of early (30-day) and late (30-day to 12-month) RH. Eighty-nine patients (27.6%) were readmitted to hospital during the study period and early RH occurred in 27%. The median time from MitraClip to RH was 99 days. RH was mostly related to cardiovascular causes (66.3%). Anemia and gastrointestinal bleeding were the most frequent noncardiovascular causes. Independent predictors of early RH were length of stay ≥3 days during the index procedure (odds ratio [OR] 4.13, 95% confidence interval [CI] 1.32 to 12.91), reduction of left ventricular ejection fraction ≥5% after MitraClip implantation (OR 4.88, 95% CI 1.36 to 18.91), and severe systolic pulmonary artery pressure ≥60 mm Hg at discharge (OR 3.72, 95% CI 1.23 to 11.26). Conversely, the independent predictors of late RH were device failure (OR 4.02, 95% CI 1.22 to 13.25) and systolic pulmonary artery pressure ≥60 mm Hg at discharge (OR 2.34, 95% CI 1.01 to 5.44). In patients with early RHs, survival was significantly worse at 12 months compared with patients with late RH and no-RH (69.3% vs 82.6% vs 86%, p <0.001). In conclusion, RH is not uncommon after MitraClip implantation and cardiovascular causes represent its most frequent etiology. Clinical and echocardiographic predictors of early and late RH can be identified at discharge. Early RH carries a worse prognosis than late RH.

[The new frontiers of patent foramen ovale]. / Le nuove frontiere del forame ovale pervio.

Several evidences support the hypothesis that patent foramen ovale (PFO), especially when associated with specific anatomical features, relates to an increased incidence of paradoxical embolism including ischemic stroke. According to current guidelines, clinicians may offer percutaneous closure of PFO in rare circumstances, such as recurrent strokes despite adequate medical therapy with no other mechanism identified (American Academy of Neurology 2016) or deep venous thrombosis at high risk of recurrence (American Heart Association/American Stroke Association 2014).Recently, a device that allows percutaneous suturing of PFO with polypropylene stitches has been introduced. Preliminary data suggest that this new strategy is effective and safe because it could reduce the adverse events of the conventional approach. Moreover, it avoids to preclude any future percutaneous transeptal procedure. Larger and randomized controlled studies are warranted to validate the results obtained.

Unusual interatrial membrane in the left atrium: A newer obstacle for transseptal-based percutaneous mitral valve repair techniques?

We present a case of a patient with severe mitral regurgitation referred to our Institution for an echocardiographic examination as part of the routine workup to assess the eligibility for mitral valve percutaneous repair with either the MitraClip or Cardioband systems. Echocardiography showed the presence of an unusual interatrial membrane in the left atrium that represented a contraindication for the puncture of the interatrial septum. The patient was finally deferred to percutaneous mitral valve replacement using transapical access.

A Risk Model for Prediction of 1-Year Mortality in Patients Undergoing MitraClip Implantation.

There is a lack of specific tools for risk stratification in patients who undergo MitraClip implantation. We aimed at combining preprocedural variables with prognostic impact into a specific risk model for the prediction of 1-year mortality in patients undergoing MitraClip implantation. A total of 311 consecutive patients who underwent MitraClip implantation were included. A lasso-penalized Cox-proportional hazard regression model was used to identify independent predictors of 1-year all-cause mortality. A nomogram (GRASP [Getting Reduction of mitrAl inSufficiency by Percutaneous clip implantation] nomogram) was obtained from the Cox model. Validation was performed using internal bootstrap resampling. Forty-two deaths occurred at 1-year follow-up. The Kaplan-Meier estimate of 1-year survival was 0.845 (95% confidence interval, 0.802 to 0.895). Four independent predictors of mortality (mean arterial blood pressure, hemoglobin natural log-transformed pro-brain natriuretic peptide levels, New York Heart Association class IV at presentation) were identified. At internal bootstrap resampling validation, the GRASP nomogram had good discrimination (area under receiver operating characteristic curve of 0.78, Somers' Dxy statistic of 0.53) and calibration (le Cessie-van Houwelingen-Copas-Hosmer p value of 0.780). Conversely, the discriminative ability of the EuroSCORE II (the European System for Cardiac Operative Risk Evaluation II) and the STS-PROM (the Society of Thoracic Surgeons Predicted Risk of Mortality score) was fairly modest with area under the curve values of 0.61 and 0.55, respectively. A treatment-specific risk model in patients who undergo MitraClip implantation may be useful for the stratification of mortality at 1 year. Further studies are needed to provide external validation and support the generalizability of the GRASP nomogram.

Strategies and Outcomes of Repeat Mitral Valve Interventions after Failed MitraClip Therapy.

Percutaneous mitral valve repair (PMVR) with the MitraClip system (Abbott Vascular, Santa Clara, CA, USA) is a valid therapeutic option for patients with severe mitral regurgitation (MR) deemed to be at high or prohibitive surgical risk. Despite the reassuring data on efficacy and long-term durability of the procedure, the proportion of patients with residual or relapsing severe MR after MitraClip therapy is not negligible. In light of the detrimental prognostic impact of severe MR, repeat interventions are increasingly performed in clinical practice using different techniques. In high-risk settings, percutaneous procedures have proven to be effective and safe at reducing MR. Building on this, we sought to summarize the current landscape and clinical experience of reinterventions after failed MitraClip therapy, so as to assist physicians facing the clinical hurdle of proper treatment management after failed PMVR.

Feasibility and predictors of early discharge after percutaneous edge-to-edge mitral valve repair.

BACKGROUND: Percutaneous edge-to-edge mitral valve repair (PMVR) recently emerged as an effective treatment modality for patients with severe mitral regurgitation (MR). Length of postprocedural hospital stay may represent a modifiable cost associated with percutaneous treatment. We looked at feasibility, predictors and safety of early discharge (ED), defined as hospital discharge within 72 hours, in patients undergoing PMVR. METHODS AND RESULTS: Consecutive patients treated with MitraClip from October 2008 to December 2015 were analysed. Primary outcomes of interest were cardiovascular and non-cardiovascular mortality, rehospitalisation for heart failure and major adverse events at 30 days and 90 days. A total of 269 patients were included. Of these, 115 patients were early discharged (ED group). Rates of ED increased from 25.9% for the biennium 2008-2009 to 59.1% in 2014-2015 (p<0.001 for trend). In a penalised logistic regression model, male gender (OR=2.13, 95% CI 1.17 to 3.95) and procedural year (OR=2.13, 95% CI 1.51 to 3.11) were associated with higher probability of ED. Conversely, atrial fibrillation (OR=0.48, 95% CI 0.27 to 0.85), any Mitral Valve Academic Research Consortium bleeding (OR=0.07, 95% CI 0.01 to 0.60), log-transformed N-terminal pro-brain natriuretic peptide levels (OR=0.79, 95% CI 0.63 to 0.99) and postimplant MR grade (OR=0.60, 95% CI 0.37 to 0.94) conferred a lower likelihood of ED. In propensity score-weighted analyses, overall survival, freedom from heart failure and major adverse events at 30 days and 90 days were not different in ED and non-ED groups (all weighted log-rank p value>0.05). CONCLUSIONS: In selected patients undergoing PMVR, ED may be feasible and safe.

MitraClip Implantation for the Treatment of New-Onset Systolic Anterior Motion of the Mitral Valve After Transcatheter Aortic Valve Replacement.

New-onset systolic anterior motion of the anterior mitral valve leaflet in patients undergoing transcatheter aortic valve replacement is a rare pathophysiologic mechanism leading to postprocedural development of mitral regurgitation and, eventually, left ventricular outflow obstruction. We report the first human case of successful MitraClip implantation to treat new-onset systolic anterior motion of the mitral valve after transcatheter aortic valve replacement causing severe obstruction to left ventricular outflow that was unresponsive to standard medical therapy.

Percutaneous mitral valve repair with the MitraClip system in the elderly: One-year outcomes from the GRASP registry.

BACKGROUND: Although mitral regurgitation (MR) affects a relevant and increasing number of elderly, an optimal management of this high-risk population is challenging. METHODS AND RESULTS: The aim of this prospective, observational study was to compare one-year outcomes of MitraClip therapy in high surgical risk patients with moderate-to-severe or severe MR between patients aged <75 versus ≥75years. A total of 180 patients were included: 92 were <75years and 88 were ≥75years old. At one-year follow-up the primary efficacy endpoint (composite of death, surgery for mitral valve dysfunction and grade 3+ or 4+ MR) occurred in 41 patients (24.5%), with similar rates between those aged <75years (23.9%) and those ≥75years (25.2%), p=0.912. A total of 21 (12.2%) deaths were observed within 1year after the MitraClip procedure, without significant differences in cumulative mortality rates between elderly and younger patients (10.8% vs. 13.3%, respectively, p=0.574). Compared with baseline, the significant reduction in MR severity achieved after the procedure was sustained at one-year follow-up, in both elderly and younger patients and a significant improvement in NYHA functional class was observed in both groups. A total of 18 (10.0%) patients experienced a re-hospitalization for acute heart failure within one-year after the MitraClip procedure, with no significant differences between elderly and younger. At one-year follow-up both elderly and younger patients showed significant reductions in left ventricular volumes, with changes of similar extent between the two subgroups. CONCLUSIONS: MitraClip therapy can be considered a viable option also among subsets with more advanced age.

One-year outcomes after Absorb bioresorbable vascular scaffold implantation in routine clinical practice.

AIMS: Our aim was to report one-year outcomes of Absorb bioresorbable scaffold implantation under real-world conditions in an all-comers population of patients with high proportions of complex lesions. METHODS AND RESULTS: Patients undergoing Absorb 1.1 implantation were included in a single-centre, prospective, all-comers registry. The primary outcome was target lesion failure (TLF), defined as the combination of cardiac death, target vessel myocardial infarction (MI), or clinically driven target lesion revascularisation (TLR). A total of 319 patients received 604 Absorb BVS in 406 lesions. Of note, 24.8% of patients had diabetes and 49.5% presented with an acute coronary syndrome. A total of 51% of lesions were type B2/C. The reference vessel diameter and lesion length were 2.9±0.5 and 21.2±16.8 mm, respectively. The one-year cumulative rate of TLF was 4.9%. Rates of cardiac death, target vessel MI and TLR were 0.9%, 1.3% and 4.2%, respectively. The cumulative one-year rate of definite/probable scaffold thrombosis was 1.3%, with all events occurring within 30 days. CONCLUSIONS: These data suggest that twelve-month clinical outcomes of Absorb use in "real-world" unselected patients with high proportions of complex lesions are reasonably good.

Usefulness of the logistic clinical SYNTAX score for predicting 1-year mortality in patients undergoing percutaneous coronary intervention of the left main coronary artery.

OBJECTIVES: To externally validate the logistic clinical SYNTAX in patients undergoing percutaneous coronary intervention (PCI) of the left main coronary artery (LMCA). BACKGROUND: A novel version of the clinical SYNTAX score (CSS) has been recently introduced to overcome the limitations of categorical risk scores for PCI by the incorporation of clinical variables and the SYNTAX score (SXscore) into a logistic formula for predicting 1-year mortality. METHODS: Core and extended models of the logistic CSS (logCSS(core) and logCSS(ext)) were applied to 400 patients undergoing LMCA PCI, and their performance was compared with those of the standard CSS, SXscore, and age, creatinine, and ejection fraction (ACEF) score by different measures of discrimination and calibration. RESULTS: A significant gradient in the distribution of 1-year mortality was noted with all the models (P < 0.001), with the SYNTAX and ACEF scores showing the lowest (0.64) and the highest (0.75) c-statistic, respectively. Based on Somers' D(xy) rank correlation, discrimination of both the logCSS(core) and the logCSS(ext) was numerically lower than that of the ACEF score. The logCSS(core) was miscalibrated toward underpredicting all-cause mortality in low-predicted probabilities, while the logCSS(ext) tended to underpredict in low-predicted probabilities and overpredict in high-predicted probabilities. Slope and intercept values reflected a better calibration ability of the logCSS(core) compared with the logCSS(ext). The global accuracy of the logCSS(core) was superior to that of the logCSS(ext) (Brier score 0.087 vs. 0.095). CONCLUSIONS: A personalized approach to risk stratification of LMCA PCI with the logistic CSS is feasible and of potential clinical utility. However, in this study, the logistic CSS did not achieve superior discrimination compared with other categorical models, and suffered from mild to moderate miscalibration.

Comparative one-year effectiveness of percutaneous coronary intervention versus coronary artery bypass grafting in patients <75 versus ≥75 years with unprotected left main disease (from the CUSTOMIZE Registry).

There is a lack of knowledge on the interaction between age and left main coronary artery revascularization. The aim of this study was to investigate the comparative effectiveness of percutaneous coronary intervention (PCI) with drug-eluting stents and coronary artery bypass grafting (CABG) in patients with left main coronary artery disease aged <75 versus ≥75 years. Of a total of 894 patients included, 692 (77.4%) were aged <75 years and 202 (23.6%) ≥75 years. PCI was found to be significantly different from CABG with respect to the composite of major adverse cardiac events at 1-year follow-up in patients aged <75 years (15.5% vs 8.5%, p = 0.01) but not in those aged ≥75 years (16.4% vs 13.9%, p = 0.65). This finding was consistent after statistical adjustment for baseline confounders in the 2 groups (adjusted hazard ratio [AHR] 2.2, 95% confidence interval 1.2 to 4.1, p = 0.016 in younger patients; AHR 0.9, 95% confidence interval 0.3 to 3.0, p = 0.88 in older patients). In the 2 groups, PCI and CABG showed similar adjusted risks for all-cause death, cardiac death, and myocardial infarction. Target lesion revascularization occurred more frequently in patients aged <75 years treated with PCI compared to CABG (AHR 5.1, 95% confidence interval 1.9 to 13.6, p = 0.001) but not in those aged ≥75 years. A significant interaction between age and treatment with regard to major adverse cardiac events was identified (adjusted p for interaction = 0.034). In conclusion, compared to younger patients, elderly patients with left main disease are likely to derive the maximal gain from a less invasive procedure such as PCI.

Safety and effectiveness of the Catania Polyzene-F coated stent in real world clinical practice: 12-month results from the ATLANTA 2 registry.

AIMS: The pivotal ATLANTA first-in-man study showed the promising safety and efficacy profile of the novel Catania™ stent in a population with ~20% American College of Cardiology/American Heart Association (ACC/AHA) type C coronary lesions. The ATLANTA 2 registry was designed to evaluate the 12-month safety and efficacy of the Catania stent in a broader real world scenario. METHODS AND RESULTS: The ATLANTA 2 registry was a prospective, non-randomised, single-arm study of patients with symptomatic ischaemic heart disease and de novo lesions of native coronary arteries. A total of 300 patients (396 lesions) were recruited and 482 Catania stents were implanted. At 12 months, major adverse cardiac events were 8.8%, mainly driven by target lesion revascularisation (6.5%). Cardiac death and non-fatal myocardial infarction occurred in 2.5% and 0.7% of patients, respectively. Subacute definite or probable stent thrombosis was 0.7%. No late stent thrombosis was recorded. Compared with patients treated with drug-eluting stents or bare metal stents in the study period, those treated with Catania stents experienced similar outcomes at one year. CONCLUSIONS: The 12-month results of the ATLANTA 2 registry confirmed the positive results of the ATLANTA first-in-man trial in a more complex population. A randomised trial is needed to assess the comparative value of the Catania stent over currently-used drug-eluting stents or bare metal stents.

Detection of very early stent healing after primary angioplasty: an optical coherence tomographic observational study of chromium cobaltum and first-generation drug-eluting stents. The DETECTIVE study.

BACKGROUND: Lack of stent coverage appears to be associated with stent thrombosis, a problem of particular concern in patients with ST elevation myocardial infarction (STEMI). METHODS: The DETECTIVE European Multicenter Registry was set up to address the early modality of stent healing in the setting of STEMI. The Registry compared, with an early optical coherence tomography (OCT) evaluation performed at 3-7 days, the patterns of coverage and apposition of the first generation of drug-eluting stents (DESs) and cobalt chromium non-drug-eluting stents (CCSs) that were deployed in culprit lesions and in non-culprit segments. The Registry included only patients with a multi-vessel disease to allow, at 3-7 days from the first angioplasty, a deferred OCT examination and a staged intervention in another vessel. RESULTS: 28 stented lesions (15 patients) eventually entered the final OCT assessment. 13 stents were first-generation DESs, while the remaining 15 were CCSs. 18 stents (64%) were deployed at culprit STEMI lesions, and the remaining 10 (36%) were deployed at non-culprit sites. The distribution of clinical and procedural variables in DES and CCS as well as in culprit and non-culprit sites was not different. In total, 27,019 struts were analysed in 28 stents. The percentage of stent uncoverage in the overall analysis was 11.7%, while the percentage of malapposition and that of struts covered with thrombus were 4.8% and 2.2%, respectively. A low percentage of strut uncoverage was found in all the four studied subgroups: DES 12.8%, CCS 10.9%, stents deployed in culprit lesions 13.2% and stents deployed in non-culprit lesions 8.7%. CONCLUSIONS: In conclusion, our data show that in patients with STEMI, a very high percentage of stent struts is covered by an early thin rim of tissue within 7 days after stent positioning. The present data bring new insights in the mechanism and timing of strut coverage.