Conservative, surgical, and percutaneous treatment for mitral regurgitation shortly after acute myocardial infarction.

AIMS: Severe mitral regurgitation (MR) following acute myocardial infarction (MI) is associated with high mortality rates and has inconclusive recommendations in clinical guidelines. We aimed to report the international experience of patients with secondary MR following acute MI and compare the outcomes of those treated conservatively, surgically, and percutaneously. METHODS AND RESULTS: Retrospective international registry of consecutive patients with at least moderate-to-severe MR following MI treated in 21 centres in North America, Europe, and the Middle East. The registry included patients treated conservatively and those having surgical mitral valve repair or replacement (SMVR) or percutaneous mitral valve repair (PMVR) using edge-to-edge repair. The primary endpoint was in-hospital mortality. A total of 471 patients were included (43% female, age 73 ± 11 years): 205 underwent interventions, of whom 106 were SMVR and 99 PMVR. Patients who underwent mitral valve intervention were in a worse clinical state (Killip class ≥3 in 60% vs. 43%, P < 0.01), but yet had lower in-hospital and 1-year mortality compared with those treated conservatively [11% vs. 27%, P < 0.01 and 16% vs. 35%, P < 0.01; adjusted hazard ratio (HR) 0.28, 95% confidence interval (CI) 0.18-0.46, P < 0.01]. Surgical mitral valve repair or replacement was performed earlier than PMVR [median of 12 days from MI date (interquartile range 5-19) vs. 19 days (10-40), P < 0.01]. The immediate procedural success did not differ between SMVR and PMVR (92% vs. 93%, P = 0.53). However, in-hospital and 1-year mortality rates were significantly higher in SMVR than in PMVR (16% vs. 6%, P = 0.03 and 31% vs. 17%, P = 0.04; adjusted HR 3.75, 95% CI 1.55-9.07, P < 0.01). CONCLUSIONS: Early intervention may mitigate the poor prognosis associated with conservative therapy in patients with post-MI MR. Percutaneous mitral valve repair can serve as an alternative for surgery in reducing MR for high-risk patients.

Procedural and clinical outcomes after repeat edge-to-edge transcatheter mitral valve repair.

BACKGROUND AND OBJECTIVES: Evidence regarding redo percutaneous interventions for recurrent mitral regurgitation is scarce. We ought to evaluate procedural and clinical outcomes of repeated edge-to-edge transcatheter mitral valve repair (TMVR) interventions. METHODS: This multicenter study collected individual data from eight high-volume TMVR Centers in Spain. Between 2012 and 2020, all patients undergoing a second edge-to-edge TMVR intervention (Redo) were included in the study. RESULTS: Among a total of 1028 procedures, 31 patients (3%) with residual MR ≥ 3 at follow-up underwent a second procedure (Redo). Redo intervention was mainly conducted between the first and second year after the first procedure. The most common cause of MR progression was partial detachment (46.7%) followed by LV remodeling (35.5%). Procedural success was achieved in 87% of cases. After a mean follow-up of 1.75 ± 1.54 years, all-cause and cardiovascular mortality were 48.1% and 25%, respectively. Nearly half of the patients (48.1%) required at least one hospital admission for CHF within the follow-up period. However, most of the patients presented symptomatic improvement as depicted by an NYHA class ≤2. Elective mitral surgery was conducted in only one patient at follow-up due to insufficient MR reduction. CONCLUSIONS: According to our findings, redo edge-to-edge TMVR interventions were feasible and safe with a high procedural success rate. Clinical and echocardiographic follow-up showed however modest long-term results in this specific setting.

Use of MitraClip for mitral valve repair in patients with acute mitral regurgitation following acute myocardial infarction: Effect of cardiogenic shock on outcomes (IREMMI Registry).

OBJECTIVES: To assess outcomes in patients with acute mitral regurgitation (MR) following acute myocardial infarction (AMI) who received percutaneous mitral valve repair (PMVR) with the MitraClip device and to compare outcomes of patients who developed cardiogenic shock (CS) to those who did not (non-CS). BACKGROUND: Acute MR after AMI may lead to CS and is associated with high mortality. METHODS: This registry analyzed patients with MR after AMI who were treated with MitraClip at 18 centers within eight countries between January 2016 and February 2020. Patients were stratified into CS and non-CS groups. Primary outcomes were mortality and rehospitalization due to heart failure. Secondary outcomes were acute procedural success, functional improvement, and MR reduction. Multivariable Cox regression analysis evaluated association of CS with clinical outcomes. RESULTS: Among 93 patients analyzed (age 70.3 ± 10.2 years), 50 patients (53.8%) experienced CS before PMVR. Mortality at 30 days (10% CS vs. 2.3% non-CS; p = .212) did not differ between groups. After median follow-up of 7 months (IQR 2.5-17 months), the combined event mortality/re-hospitalization was similar (28% CS vs. 25.6% non-CS; p = .793). Likewise, immediate procedural success (90% CS vs. 93% non-CS; p = .793) and need for reintervention (CS 6% vs. non-CS 2.3%, p = .621) or re-admission due to HF (CS 13% vs. NCS 23%, p = .253) at 3 months did not differ. CS was not independently associated with the combined end-point (hazard ratio 1.1; 95% CI, 0.3-4.6; p = .889). CONCLUSIONS: Patients found to have significant MR during their index hospitalization for AMI had similar clinical outcomes with PMVR whether they presented in or out of cardiogenic shock, provided initial hemodynamic stabilization was first achieved before PMVR.

Effect of hydroxychloroquine, azithromycin and lopinavir/ritonavir on the QT corrected interval in patients with COVID-19.

BACKGROUND: Administration of Hydroxychloroquine and Azithromycin in patients with coronavirus disease 2019 (COVID-19) prolongs QTc corrected interval (QTc). The effect and safety of Lopinavir/Ritonavir in combination with these therapies have seldom been studied. OBJECTIVES: Our aim was to evaluate changes in QTc in patients receiving double (Hydroxychloroquine + Azithromycin) and triple therapy (Hydroxychloroquine + Azithromycin + Lopinavir/Ritonavir) to treat COVID-19. Secondary outcome was the incidence of in-hospital all-cause mortality. METHODS: Patients under treatment with double (DT) and triple therapy (TT) for COVID-19 were consecutively included in this prospective observational study. Serial in-hospital electrocardiograms were performed to measure QTc at baseline and during therapy. RESULTS: 168 patients (±66.2 years old) were included: 32.1% received DT and 67.9% received TT. The mean baseline QTc was 410.33 ms. Patients under DT and TT prolonged QTc interval respect baseline values (p < 0.001), without significant differences between both therapy groups (p = 0.748). Overall, 33 patients (19.6%) had a peak QTc and/or an increase QTc 60 ms from baseline, with a higher prevalence among those with hypokalemia (p = 0.003). All-cause mortality was similar between both strategy groups (p = 0.093) and high risk QTc prolongation was no related to clinical events in this series. CONCLUSIONS: DT and TT prolong the QTc in patients with COVID-19. Addition of Lopinavir/Ritonavir on top of Hydroxychloroquine and Azithromycin did not increase QTc compared to DT.

Previously diagnosed cancer and mortality after ST-segment elevation acute myocardial infarction treated with primary angioplasty.

OBJECTIVE: We investigated if a previous cancer diagnosis influences the outcome of patients with STEMI treated with primary coronary intervention (PCI). BACKGROUND: ST-segment myocardial infarction (STEMI) and a history of cancer can coexist because both have a high incidence and prevalence. METHODS: Prospective cohort observational study, The primary end-point was total mortality. RESULTS: We included 917 patients, 53 of them (5.8%) were cancer survivors. During follow-up (median, 643 days [interquartile range, 258 to 1,015 days]), 100 patients died, 88 (10.2%) patients without a cancer diagnosis and 12 (22.6%) patients with a previous cancer diagnosis, which was significantly different (log-rank test = 8.4, p = .004). Cancer patients were older (73.4 (11.5) vs. 65.2 (13.8) years, p < .001), with a lower prevalence of previous stroke (1.1% vs. 2.2%, p = .002). Their hemoglobin concentration was also lower (13.4 (2.1) vs. 14.4 (1.7) g/L, p = .001). A trend towards a lower use of coronary stents in cancer survivors was noted (p = .061). Cancer was associated with a high probability of death (HR = 2.37, 95% confidence interval [CI] 1.30-4.34, p = .005). When confounding variables were included, this association was no longer significant (HR = 1.63, 95% CI 0.84-3.18, p = .150). CONCLUSIONS: Patients with a previous cancer diagnosis who had an acute STEMI treated by primary PCI did not seem to have a worse prognosis. The difference in the crude mortality rate can be explained by the baseline differences between both groups. Previous cancer diagnosis should not be included in the clinical decision process when a patient is having an acute STEMI.

Three- and 6-month optical coherence tomographic surveillance following percutaneous coronary intervention with the Angiolite® drug-eluting stent: The ANCHOR study.

BACKGROUND: Pre-clinical results of a novel open-cell, thin strut, durable polymer, laser cut cobalt chromium sirolimus-eluting stent (Angiolite) were promising. Using quantitative optical coherence tomographic (OCT) analyses, we explored the healing characteristics of the Angiolite DES system at 3- and 6-months post implantation. METHODS: A total of 103 patients with de novo coronary lesions underwent percutaneous coronary intervention with the Angiolite DES and were randomized 1:3 into two cohorts for angiographic and OCT follow-up, with 28 and 70 patients returning for 3- or 6-month post-PCI surveillance, respectively. The primary endpoints were the 6-month rates of OCT-derived neointimal proliferation, strut coverage and incomplete strut apposition (ISA), whilst the secondary endpoints were 3-month OCT-derived measures of strut coverage and ISA, as well as 6-month quantitative coronary angiographic-derived measures [late lumen loss (LLL), binary restenosis]. RESULTS: The Angiolite stent was successfully implanted in all patients, without periprocedural complications. At 3- and 6-months follow-up, OCT strut coverage was evident in 86.3% and 83.3% of struts, mean neointimal thickness was 73.7 ± 46.5 µm and 73.9 ± 54.3 µm, mean neo-intimal area obstruction of 5.8% ±10.3% and 4.4% ± 11.3%, and ISA rates were 1.3% ± 7.3% and 1.1% ± 6.2%, respectively. In-stent LLL at 6 months was 0.07 ± 0.37 mm, with a binary in-stent angiographic restenosis rate of 0% without any stent thrombosis, myocardial infarction or cardiovascular death, with 1 patient undergoing ischemia-driven target-lesion revascularization. CONCLUSIONS: At 6 months, the Angiolite DES was safe with high rates of strut coverage, modest degrees of neointimal hyperplasia and very low rates of strut malapposition. These data coupled with the absence of in-stent binary restenosis and a very low 6-month in-stent LLL point towards an efficacious DES. Future studies are required to evaluate its efficacy in broader lesion subsets with longer follow-up.

Trileaflet Mitral Valve Treated with the MitraClip® System.

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+.

Survival Advantage of MitraClip® Over Medical Treatment in Patients with Mitral Regurgitation: A Meta-Analysis.

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.

Percutaneous Closure of Massive Mitral Paravalvular Leak.

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.

Effect of early metoprolol on infarct size in ST-segment-elevation myocardial infarction patients undergoing primary percutaneous coronary intervention: the Effect of Metoprolol in Cardioprotection During an Acute Myocardial Infarction (METOCARD-CNIC) trial.

BACKGROUND: The effect of ß-blockers on infarct size when used in conjunction with primary percutaneous coronary intervention is unknown. We hypothesize that metoprolol reduces infarct size when administered early (intravenously before reperfusion). METHODS AND RESULTS: Patients with Killip class II or less anterior ST-segment-elevation myocardial infarction (STEMI) undergoing percutaneous coronary intervention within 6 hours of symptoms onset were randomized to receive intravenous metoprolol (n=131) or not (control, n=139) before reperfusion. All patients without contraindications received oral metoprolol within 24 hours. The predefined primary end point was infarct size on magnetic resonance imaging performed 5 to 7 days after STEMI. Magnetic resonance imaging was performed in 220 patients (81%). Mean ± SD infarct size by magnetic resonance imaging was smaller after intravenous metoprolol compared with control (25.6 ± 15.3 versus 32.0 ± 22.2 g; adjusted difference, -6.52; 95% confidence interval, -11.39 to -1.78; P=0.012). In patients with pre-percutaneous coronary intervention Thrombolysis in Myocardial Infarction grade 0 to 1 flow, the adjusted treatment difference in infarct size was -8.13 (95% confidence interval, -13.10 to -3.16; P=0.0024). Infarct size estimated by peak and area under the curve creatine kinase release was measured in all study populations and was significantly reduced by intravenous metoprolol. Left ventricular ejection fraction was higher in the intravenous metoprolol group (adjusted difference, 2.67%; 95% confidence interval, 0.09-5.21; P=0.045). The composite of death, malignant ventricular arrhythmia, cardiogenic shock, atrioventricular block, and reinfarction at 24 hours in the intravenous metoprolol and control groups was 7.1% and 12.3%, respectively (P=0.21). CONCLUSIONS: In patients with anterior Killip class II or less ST-segment-elevation myocardial infarction undergoing primary percutaneous coronary intervention, early intravenous metoprolol before reperfusion reduced infarct size and increased left ventricular ejection fraction with no excess of adverse events during the first 24 hours after STEMI. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT01311700. EUDRACT number: 2010-019939-35.

Applications of three-dimensional printing in percutaneous closure of aortic-to-right ventricle fistula after transcatheter aortic valve replacement: a case report.

Background: Percutaneous closure of aortic-to-right ventricle (ARV) fistula has emerged as an alternative to surgical management in selected cases. The use of three-dimensional (3D) printing in interventional planning for structural heart disease provides a concrete understanding, and it is useful in diagnostic assessment and to guide treatment approaches and to simulate procedures. Case summary: We report a case of a 70-year-old male presenting in cardiogenic shock due to severe aortic stenosis and reduced left ventricular ejection fraction. The patient had several comorbidities and was deemed not eligible for cardiac surgery. After transcatheter aortic valve replacement (TAVR), an ARV fistula was discovered on the TTE. Due to complex anatomical considerations, a 3D printed model of the patient's anatomy was employed to supplement the decision-making process and technical planning of percutaneous ARV closure. Successful closure of the fistula with the use of the Amplatzer atrial septal occluder was subsequently performed. Discussion: Three-dimensional printing improves the understanding of complex structures of cardiac diseases, allowing for enhanced planning and simulation of the procedure. This case, demonstrating the effective percutaneous closure of a TAVR-related ARV fistula facilitated by the use of 3D printed anatomical models in the pre-procedural phase, highlights the technology's potential in advancing patient-specific treatment approaches.

Impact of initiation of SGLT2 inhibitor treatment on the development of arrhythmias in patients with implantable cardiac devices.

INTRODUCTION AND OBJECTIVES: Sodium-glucose cotransporter type 2 inhibitors (SGLT2i) have been associated with improved prognosis in patients with heart failure, but their impact on atrial arrhythmic (AA) and ventricular arrhythmic (VA) events is not fully understood. METHODS: This multicenter retrospective study included patients with implantable cardioverter-defibrillators who initiated treatment with SGLT2i. AA and VA events were compared in 2 time periods for each patient: 1 year before and 1 year after starting SGLT2i. RESULTS: The study included 195 patients (66.8 [61.3-73.1] years, 18.5% women). In the post-SGLT2i period, there was a reduction in the percentage of patients with any VA (pre: 52.3% vs post: 30.3%; P<.001) and clinically relevant VA (excluding nonsustained ventricular tachycardia) (pre: 21.5% vs post: 8.7%; P<.001). There was also a decrease in the number of episodes per patient/y of nonsustained ventricular tachycardia (pre: 2 (1-5) vs post: 1 (0-2); P<.001) and sustained ventricular tachycardia (pre: 1 (1-3) vs post: 0 (0-2); P=0.046). However, no differences were observed in the prevalence of AA (24.7% vs 18.8%; P=.117) or the burden of atrial fibrillation (pre: 0% (0-0.1) vs post: 0% (0-0); P=.097). CONCLUSIONS: Initiation of SGLT2i treatment was associated with a decrease in the percentage of patients with relevant VA but this effect was not observed for AA.

Global Longitudinal Strain Predicts Outcomes in Patients with Reduced Left Ventricular Function Undergoing Transcatheter Edge-to-Edge Mitral Repair.

BACKGROUND: The timing and selection of optimal candidates for mitral transcatheter edge-to-edge valve repair remains to be fully determined, especially in cases with severely depressed left ventricular ejection fraction (LVEF). The objective of this study is to evaluate the prognostic value of myocardial strain (LVGLS) in this setting. METHODS: Retrospectively, 172 consecutive patients with LVEF ≤40% and severe MR treated with MitraClip were included. Four groups were generated according to the LVEF (<30% or ≥30%) and median LVGLS. The primary end-point was cardiovascular mortality. RESULTS: Procedural success was high (96.5%) and complications were rare. At one-year follow-up, 82.5% of patients maintained MR grade ≤2, 79.2% were at a NYHA class ≤II and a reduction of 80% in heart failure admissions was observed in all groups. Interestingly, among patients with a more depressed LVEF, LVGLS was found to be an independent predictor for cardiovascular mortality (HR: 3.3; 95% CI: 1.1-10, p = 0.023). CONCLUSIONS: Mitral valve repair with MitraClip is safe and it improves the mid-term functional class of patients regardless of LVEF. LVGLS can help in the selection of optimal candidates and timing for this procedure, as well as in the recognition of those patients with worse prognoses.

Study design for the "effect of METOprolol in CARDioproteCtioN during an acute myocardial InfarCtion" (METOCARD-CNIC): a randomized, controlled parallel-group, observer-blinded clinical trial of early pre-reperfusion metoprolol administration in ST-segment elevation myocardial infarction.

BACKGROUND: Infarct size predicts post-infarction mortality. Oral ß-blockade within 24 hours of a ST-segment elevation acute myocardial infarction (STEMI) is a class-IA indication, however early intravenous (IV) ß-blockers initiation is not encouraged. In recent magnetic resonance imaging (MRI)-based experimental studies, the ß(1)-blocker metoprolol has been shown to reduce infarct size only when administered before coronary reperfusion. To date, there is not a single trial comparing the pre- vs. post-reperfusion ß-blocker initiation in STEMI. OBJECTIVE: The METOCARD-CNIC trial is testing whether the early initiation of IV metoprolol before primary percutaneous coronary intervention (pPCI) could reduce infarct size and improve outcomes when compared to oral post-pPCI metoprolol initiation. DESIGN: The METOCARD-CNIC trial is a randomized parallel-group single-blind (to outcome evaluators) clinical effectiveness trial conducted in 5 Counties across Spain that will enroll 220 participants. Eligible are 18- to 80-year-old patients with anterior STEMI revascularized by pPCI ≤6 hours from symptom onset. Exclusion criteria are Killip-class ≥III, atrioventricular block or active treatment with ß-blockers/bronchodilators. Primary end point is infarct size evaluated by MRI 5 to 7 days post-STEMI. Prespecified major secondary end points are salvage-index, left ventricular ejection fraction recovery (day 5-7 to 6 months), the composite of (death/malignant ventricular arrhythmias/reinfarction/admission due to heart failure), and myocardial perfusion. CONCLUSIONS: The METOCARD-CNIC trial is testing the hypothesis that the early initiation of IV metoprolol pre-reperfusion reduces infarct size in comparison to initiation of oral metoprolol post-reperfusion. Given the implications of infarct size reduction in STEMI, if positive, this trial might evidence that a refined use of an approved inexpensive drug can improve outcomes of patients with STEMI.

Structural and Functional Evaluation of Coronary Arteries Treated With ABSORB Bioresorbable Vascular Scaffold at 5-Year Follow-Up.

Although complete bioresorbable vascular scaffold (BVS) resorption has been demonstrated at 5-year follow-up, whether corresponding vasomotor function restoration occurs remains unknown. The objective was to simultaneously assess the structural healing response along with vasomotor responses at 5-year follow-up of BVS implantation. We studied consecutive patients treated with ABSORB-BVS at 5-year follow-up (n = 31), who were recruited from a multicenter registry and were contacted to undergo a research protocol-driven repeat coronary angiogram involving intracoronary optical coherence tomography (OCT) and invasive coronary endothelial function testing. Epicardial endothelium-dependent vasomotion was defined as any vasodilatation after intracoronary acetylcholine (ACh), whereas endothelium-independent vasomotion was defined as any vasodilatation after intracoronary nitroglycerine (NTG), using quantitative coronary angiography. The mean implantation time point was 60.5 ± 4.6 months. OCT imaging demonstrated complete scaffold resorption in all patients. New coronary lesions (stenosis >50%) were found in 5 patients (16.1%), 3 of them underwent ad hoc percutaneous revascularization (9.7%). Intracoronary ACh (27 patients) and NTG testing (30 patients) was performed. Quantitative coronary angiography analysis demonstrated vasoconstriction after ACh administration and lack of response to NTG in BVS segments (mean lumen diameter = 2.00 ± 0.61 mm at baseline vs 1.74 ± 0.70 mm post-ACh, p <0.001; 2.05 ± 0.54 mm at baseline vs 2.03 ± 0.50 mm post-NTG, p = 0.69). OCT lumen analysis demonstrated similar vasoconstrictive responses to ACh (mean lumen area = 5.31 ± 2.26 mm2 at baseline vs 5.12 ± 2.55 mm2 post-ACh, p = 0.007) but had a vasodilatory response to NTG (5.96 ± 2.35 mm2 at baseline vs 6.17 ± 2.55 mm2 post-NTG, p<0.001). In conclusion, complete ABSORB-BVS resorption was demonstrated at 5-year follow-up. However, this healing response was associated with endothelium-dependent vasomotor dysfunction within the BVS segment.

Outcomes of Nonagenarians With Acute Coronary Syndrome.

OBJECTIVES: Nonagenarians are a fast-growing age group among cardiovascular patients, but data about their management and prognosis after an acute coronary syndrome (ACS) is scarce. This study aimed to analyze characteristics of nonagenarian patients with ACS and to compare in-hospital and 1-year clinical outcomes between those treated with medical treatment (MT) alone and those receiving percutaneous coronary intervention (PCI). DESIGN: Multicenter observational study. SETTING AND PARTICIPANTS: We included consecutive nonagenarian patients with ACS admitted at 4 academic centers between 2005 and 2018. Only patients with type 1 myocardial infarction were included. METHODS: Standardized definitions of all patient-related variables, clinical diagnoses, and hospital complications and outcomes were used. The primary endpoint was 1-year all-cause mortality. Long-term survival was compared between patients undergoing PCI and those managed with MT alone. Given differences in baseline characteristics could substantially interfere in outcomes, 3 sensitivity analyses were performed to adjust for confounders. RESULTS: A total of 680 nonagenarians were included (59% females). Of them, 373 (55%) patients presented with non-ST-segment elevation ACS (NSTE-ACS) and 307 (45%) with ST-segment elevation myocardial infarction (STEMI). A coronary angiogram was performed in 115 (31%) of NSTE-ACS and in 182 (60%) of STEMI patients with subsequent PCI in 81 (22%) and 156 (51%), respectively. Overall mortality rates were 17% in-hospital and 39% at 1-year follow-up. PCI was independently associated with a decreased risk of 1-year all-cause death [hazard ratio (HR) 0.57, 95% confidence interval (CI) 0.35, 0.95; P < .05], mainly observed in those patients without disability (HR 0.59, 95% CI 0.37, 0.94; P < .01) and lower Killip class (HR 0.50, 95% CI 0.28, 0.89; P < .001). CONCLUSIONS AND IMPLICATIONS: The prognosis of nonagenarians after an ACS was associated with comorbidities and the therapeutic approach. Although PCI appeared to be a safe and effective strategy, it is still necessary to refine the decision-making process in this high-risk population group.

Rationale and design of the pragmatic clinical trial tREatment with Beta-blockers after myOcardial infarction withOut reduced ejection fracTion (REBOOT).

AIMS: There is a lack of evidence regarding the benefits of ß-blocker treatment after invasively managed acute myocardial infarction (MI) without reduced left ventricular ejection fraction (LVEF). METHODS AND RESULTS: The tREatment with Beta-blockers after myOcardial infarction withOut reduced ejection fracTion (REBOOT) trial is a pragmatic, controlled, prospective, randomized, open-label blinded endpoint (PROBE design) clinical trial testing the benefits of ß-blocker maintenance therapy in patients discharged after MI with or without ST-segment elevation. Patients eligible for participation are those managed invasively during index hospitalization (coronary angiography), with LVEF >40%, and no history of heart failure (HF). At discharge, patients will be randomized 1:1 to ß-blocker therapy (agent and dose according to treating physician) or no ß-blocker therapy. The primary endpoint is a composite of all-cause death, non-fatal reinfarction, or HF hospitalization over a median follow-up period of 2.75 years (minimum 2 years, maximum 3 years). Key secondary endpoints include the incidence of the individual components of the primary composite endpoint, the incidence of cardiac death, and incidence of malignant ventricular arrhythmias or resuscitated cardiac arrest. The primary endpoint will be analysed according to the intention-to-treat principle. CONCLUSION: The REBOOT trial will provide robust evidence to guide the prescription of ß-blockers to patients discharged after MI without reduced LVEF.

Transcatheter edge-to-edge mitral valve repair in patients with mitral annulus calcification.

BACKGROUND: MAC is commonly found in patients affected with MR, and it is associated with high morbidity, mortality and worse cardiac surgical outcomes. Transcatheter edge-to-edge repair could be an alternative treatment, although there is little evidence in this population. AIMS: The aim of this study was to analyse the safety, efficacy and durability of MitraClip implantation in patients affected with mitral regurgitation (MR) and mitral annulus calcification (MAC). METHODS: We analysed the outcomes of 61 suitable patients affected with severe MR and moderate or severe MAC (the "MAC" group) and 791 patients with no or mild MAC (the "NoMAC" group) treated with the MitraClip device. RESULTS: Procedural success was similar (91.8% vs 95.1%, p=0.268, in MAC and NoMAC, respectively), with a very low rate of complications. At one-year follow-up, 90.6% of MAC and 79.5% of NoMAC patients had MR grade ≤2 (p=0.129), 80% in both groups remained in NYHA Functional Class ≤II, and a significant reduction in cardiac readmissions was observed (65% vs 78% in MAC vs NoMAC, p=0.145). One-year mortality tended to be higher in MAC patients (19.7% vs 11.3%, p=0.050), with no difference in cardiovascular mortality (15.3% vs 9.2%, p=0.129). CONCLUSIONS: MitraClip use in selected patients with moderate or severe MAC is safe, feasible and achieves good clinical and echocardiographic results at one-year follow-up.

Center Valve Preference and Outcomes of Transcatheter Aortic Valve Replacement: Insights From the AMTRAC Registry.

BACKGROUND: Data on outcomes of transcatheter aortic valve replacement (TAVR) using balloon-expandable valves (BEVs) or self-expandable valves (SEVs) as well as the impact of center valve preference on these outcomes are limited. OBJECTIVES: The aim of this study was to compare outcomes of TAVR procedures using third-generation BEVs and SEVs stratified by center valve preference. METHODS: In a multicenter registry (n = 17), 13 centers exhibited valve preference (66.6%-90% of volume) and were included. Outcomes were compared between BEVs and SEVs stratified by center valve preference. RESULTS: In total, 7,528 TAVR procedures (3,854 with SEVs and 3,674 with BEVs) were included. The mean age was 81 years, and the mean Society of Thoracic Surgeons score was 5.2. Baseline characteristics were similar between BEVs and SEVs. Need for pacemaker implantation was higher with SEVs at BEV- and SEV-dominant centers (17.8% vs 9.3% [P < 0.001] and 12.7% vs 10.0% [P = 0.036], respectively; HR: 1.51; P for interaction = 0.021), risk for cerebrovascular accident was higher with SEVs at BEV-dominant but not SEV-dominant centers (3.6% vs 1.1% [P < 0.001] and 2.2% vs 1.4% [P = 0.162]; HR: 2.08; P for interaction < 0.01). Aortic regurgitation greater than mild was more frequent with SEVs at BEV-dominant centers and similar with BEVs regardless of center dominance (5.2% vs 2.8% [P < 0.001] and 3.4% vs 3.7% [P = 0.504], respectively). Two-year mortality was higher with SEVs at BEV-dominant centers but not at SEV-dominant centers (21.9% vs 16.9% [P = 0.021] and 16.8% vs 16.5% [P = 0.642], respectively; HR: 1.20; P for interaction = 0.032). CONCLUSIONS: Periprocedural outcomes, aortic regurgitation greater than mild, and 2-year mortality are worse when TAVR is performed using SEVs at BEV-dominant centers. Outcomes are similar regardless of valve type at SEV-dominant centers. The present results stress the need to account for this factor when comparing BEV and SEV outcomes. (The Aortic+Mitral Transcatheter [AMTRAC] Valve Registry; NCT04031274).

Prevalence of bleeding secondary to anticoagulation and mortality in patients with atrial fibrillation admitted with SARS-CoV-2 infection.

Introduction and purpose: Atrial fibrillation (AF) is common in patients admitted with severe COVID-19. However, there is limited data about the management of chronic anticoagulation therapy in these patients. We assessed the anticoagulation and incidence of major cardiovascular events in hospitalized patients with AF and COVID-19. Methods: We retrospectively investigated all consecutive patients with AF admitted with COVID-19 between March and May 2020 in 9 Spanish hospitals. We selected a control group of non-AF patients consecutively admitted with COVID-19. We compared baseline characteristics, incidence of major bleeding, thrombotic events and mortality. We used propensity score matching (PSM) to minimize potential confounding variables, as well as a multivariate analysis to predict major bleeding and death. Results: 305 patients admitted with AF and COVID-19 were included. After PSM, 151 AF patients were matched with 151 control group patients. During admission, low-molecular-weight heparin was the principal anticoagulant and the incidence of major bleeding and mortality were higher in the AF group [16 (10.6%) vs 3 (2%), p = 0.003; 52 (34.4%) vs 35 (23.2%), p = 0.03, respectively]. The multivariate analysis showed the presence of AF as independent predictor of in-hospital major bleeding and mortality in COVID-19 patients. In AF group, a secondary multivariate analysis identified high levels of D-dimer as independent predictor of in-hospital major bleeding. Conclusions: AF patients admitted with COVID-19 represent a population at high risk for bleeding and mortality during admission. It seems advisable to individualize anticoagulation therapy during admission, considering patient specific bleeding and thrombotic risk.

Antecedentes y objetivos: La fibrilación auricular (FA) es frecuente en pacientes ingresados por COVID-19 grave. Sin embargo, los datos sobre el manejo de la anticoagulación crónica en estos pacientes son escasos. Analizamos la anticoagulación y la incidencia de episodios cardiovasculares mayores en pacientes con FA ingresados por la COVID-19. Métodos: Retrospectivamente, se identificaron todos los pacientes con FA ingresados por la COVID-19 entre marzo y mayo de 2020, en 9 hospitales españoles. Se seleccionó un grupo control de pacientes ingresados consecutivamente por la COVID-19 sin FA. Se compararon las características basales, incidencia de hemorragias mayores, episodios trombóticos y mortalidad. Para reducir potenciales factores de confusión se realizó un emparejamiento por puntuación de propensión, así como un análisis multivariante para predecir hemorragia mayor y mortalidad. Resultados: Se incluyeron 305 pacientes con FA ingresados por la COVID-19. Tras el emparejamiento por puntuación de propensión, 151 pacientes con FA fueron emparejados con 151 controles. Durante el ingreso, la heparina de bajo peso molecular fue el principal anticoagulante y la incidencia de hemorragia mayor y mortalidad fue mayor en el grupo de FA (16[10,6%] vs. 3[2%], p = 0,003; 52[34,4%] vs. 35[23,2%], p = 0,03, respectivamente). El análisis multivariante demostró la presencia de FA como predictor independiente de sangrados y mortalidad intrahospitalaria en los pacientes con la COVID-19. En el grupo de FA, un segundo análisis multivariante identificó valores elevados de dímero-D como predictor independiente de hemorragia mayor intrahospitalaria. Conclusiones: Los pacientes con FA ingresados por la COVID-19 representan una población de alto riesgo de sangrado y mortalidad durante el ingreso. Parece recomendable individualizar la anticoagulación durante el ingreso, considerando el riesgo específico de sangrado y trombosis.