3D Virtual modelling, 3D printing and extended reality for planning of implant procedure of short-term and long-term mechanical circulatory support devices and heart transplantation.

Introduction: The use of three-dimensional (3D) reconstruction and printing technology, together with extended reality applied to advanced heart failure adult patients with complex anatomy, is rapidly spreading in clinical practice. We report practical experience with application to acute and chronic heart failure: planning and performing mechanical circulatory device insertion or heart transplantation. Methods: From November 2019 until February 2022, 53 3D virtual biomodels were produced for intervention planning (using Virtual/Augmented Reality and/or 3D printing), following a specific segmentation and preprocessing workflow for biomodelling, in patients with advanced heart failure due to structural heart disease or cardiomyopathies. Four of those patients were complex cases requiring mechanical circulatory support implant procedures in our center. Results: One short-term and three long-term ventricular assist device system were successfully clinically implanted after application of this technique. In other two cases with extremely high procedural risk, visualized after application of this multimodality imaging, heart transplantation was elected. Conclusion: 3D printing based planning and virtual procedure simulation, are of great importance to select appropriate candidates for mechanical circulatory support in case of complex patient anatomy and may help to diminish periprocedural complications. Extended reality represents a perspective tool in planification of complex surgical procedures or ventricular assist device insertion in this setting.

Early clinical and haemodynamic matched comparison of balloon-expandable valves.

OBJECTIVES: The balloon-expandable Sapien-3 valve demonstrated superior results in terms of residual aortic regurgitation when compared with self-expandable devices. We aimed to compare for the first-time early outcomes of Sapien-3 transcatheter heart valve (THV) with the balloon-expandable Myval device. METHODS: Consecutive real-world patients from nine European institutions with symptomatic severe aortic stenosis treated either with Sapien-3 or Myval THV devices after June 2018 were compared. Early clinical outcomes were prospectively gathered and blinded analysis of 30-day echocardiography was conducted. Matching for the following variables was performed: age, body surface area, Society of Thoracic Surgeons risk score, left ventricular function, mean gradient, transfemoral approach, aortic valvular calcium, aortic annulus mean diameter, area and eccentricity index. RESULTS: A total of 416 patients treated either with the Sapien-3 (n=286, 68.7%) or with Myval THV (n=130, 31.3%) were included and 103 pairs compared after matching. Baseline characteristics were similar. Procedural success rate (Sapien-3: 94.2%; Myval: 93.2%, p=0.219), 30-day mortality (Sapien-3: 2.9%; Myval: 0.97%, p=0.625), clinical efficacy (12.6 vs 4.9%, p=0.057) and early safety (12.6 vs 4.9%, p=0.096) were comparable. There was a lower need for new permanent pacemaker (15.5 vs 5.8% p=0.020) with Myval. No significant differences were found in terms of ≥moderate aortic regurgitation (1% for Sapien-3, 0% for Myval, p=0.314), but mean gradients were higher following Sapien-3 than after Myval (p<0.001). CONCLUSIONS: The new Myval balloon-expandable THV was favourable in terms of safety, with low rate of permanent pacemaker and with favourable residual gradients and paravalvular leak rate according to blinded echocardiographic analysis.

Impact of renin-angiotensin system inhibitors on outcomes after surgical or transcatheter aortic valve replacement. A meta-analysis.

INTRODUCTION AND OBJECTIVES: To determine whether renin-angiotensin system inhibitor (RASi) prescription is associated with better outcomes after transcatheter aortic valve implantation (TAVI) and surgical aortic valve replacement (SAVR). METHODS: All comparative studies of RASi vs no RASi prescription in patients undergoing TAVI/SAVR were gathered from PubMed, Web of Science, and Google Scholar through August, 2019. We extracted hazard ratios (HRs) with their confidence intervals (CIs) for mortality from each study and combined study-specific estimates using inverse variance-weighted averages of logarithmic HRs in the random effects model. RESULTS: We identified 6 eligible studies with a total of 21 390 patients (TAVI: 17 846; SAVR: 3544) and included them in the present meta-analysis. The 6 studies were observational comparative studies (including 3 propensity score matched and 3 cohort studies) of RASi vs no RASi prescription. The analysis demonstrated that RASi prescription was associated with significantly lower mortality in the whole group of patients undergoing aortic valve intervention (HR, 0.64; 95%CI, 0.47-0.88; P <.001). However, subgroup analysis suggested differences according to the selected therapy, with TAVI showing better mortality rates in the RASi group (HR, 0.67; 95%CI, 0.49-0.93) but not in the SAVR group (HR, 0.61; 95%CI, 0.29-1.30). No funnel plot asymmetry was identified, suggesting minimum publication bias. Sensitivity analyses sequentially eliminating dissimilar studies did not substantially alter the primary result favoring RASI prescription. CONCLUSIONS: These findings suggest a mortality benefit of RASi in patients with AS treated with aortic valve replacement that might be particularly relevant following TAVI. Future randomized studies are warranted to confirm this relevant finding.

Prognostic impact of the SYNTAX score II in patients with ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention: analysis of a four-year all-comers registry.

AIMS: This study aimed to investigate the prognostic impact of the SYNTAX score II (SS-II) on ST-segment elevation myocardial infarction (STEMI) patients undergoing a primary percutaneous coronary intervention (pPCI). METHODS AND RESULTS: This retrospective cohort study included 1,689 patients with STEMI who underwent pPCI between January 2008 and December 2016. The patients were categorised into three groups based on SS-II tertiles (SS-II low tertile <24 [n=585], SS-II intermediate tertile ≥24 and ≤34 [n=567], and SS-II high tertile >34 [n=537]). In-hospital mortality was significantly lower in patients with low and mid SS-II when compared with high SS-II (0.7% vs 0.5% vs 16.4%, p=0.001). During follow-up (median 2.35 years), a high SS-II was positively correlated with MACE (12.3% for low SS-II vs 18.3% for mid SS-II vs 43.2% for high SS-II, p=0.001), all-cause mortality (1.5% vs 3.9% vs 14.2%, p=0.001) and heart failure (0.3% vs 2.7% vs 8.2%, p=0.001). The SS-II showed additive value on top of GRACE, anatomical SYNTAX score and residual SYNTAX score. CONCLUSIONS: The SS-II in patients with STEMI undergoing pPCI adds important prognostic information regarding midterm adverse outcomes, being an independent and powerful predictor of MACE, heart failure and all-cause mortality during follow-up.

The Micra Leadless Transcatheter Pacemaker. Implantation and Mid-term Follow-up Results in a Single Center.

INTRODUCTION AND OBJECTIVES: Currently, studies on the leadless pacemaker (Micra) have mostly been limited to clinical trials with less than 6 months' follow-up and they often fail to reflect real population outcomes. We sought to evaluate electrical parameters at implantation and chronologically during follow-up, as well as the safety of this new technique. METHODS: This prospective, observational study included 30 consecutive patients, all ≥ 65 years, with an indication for single-chamber pacemaker implantation. RESULTS: Successful implantation was accomplished in all patients referred for leadless implantation. The mean age was 79.4±6.4 years (range, 66-89 years); 20 (66.6%) were men and 28 had permanent atrial fibrillation (93.3%); 1 had atrial tachycardia and 1 had sinus rhythm. Concomitant atrioventricular node ablation was performed immediately after implantation in 5 patients (16.6%), and implantation was performed after transcatheter aortic valve implantation in 2. The procedure was performed under an uninterrupted anticoagulation regimen (maximum INR 2.4) in 23 patients (76.6%). With the exception of 1 moderate pericardial effusion without tamponade, there were no severe complications. The mean follow-up was 5.3±3.3 months and 4 patients had more than 1 year of follow-up. Sensing and pacing parameters were stable both at implantation and during the short- to mid-term follow-up. CONCLUSIONS: Implantation of leadless pacemakers is feasible, safe and provides advantages over the conventional system. Further studies with longer follow-up periods will be needed before these devices become widely used in routine clinical practice.

Multivessel Versus Culprit-only Percutaneous Coronary Intervention in ST-segment Elevation Acute Myocardial Infarction: Analysis of an 8-year Registry.

INTRODUCTION AND OBJECTIVES: The optimal treatment of patients with multivessel coronary artery disease and ST-segment elevation acute myocardial infarction (STEMI) who undergo primary percutaneous coronary intervention (PCI) is controversial. The aim of this study was to access the prognostic impact of multivessel PCI vs culprit vessel-only PCI in real-world patients with STEMI and multivessel disease. METHODS: This was a retrospective cohort study of 1499 patients with STEMI diagnosis who underwent primary PCI between January 2008 and December 2015. About 40.8% (n=611) patients had multivessel disease. We performed a propensity score matched analysis to obtain 2 groups of 215 patients paired according to whether or not they had undergone multivessel PCI or culprit vessel-only PCI. RESULTS: During follow-up (median, 2.36 years), after propensity score matching, patients who underwent multivessel PCI had lower rates of mortality (5.1% vs 11.6%; Peto-Peto P=.014), unplanned repeat revascularization (7.0% vs 12.6%; Peto-Peto P=.043) and major acute cardiovascular events (22.0% vs 30.8%; Peto-Peto P=.049). These patients also showed a trend to a lower incidence of myocardial infarction (4.2% vs 6.1%; Peto-Peto P=.360). CONCLUSIONS: In real-world patients presenting with STEMI and multivessel coronary artery disease, a multivessel PCI strategy was associated with lower rates of mortality, unplanned repeat revascularization, and major acute cardiovascular events.

The Risk of Cardiovascular Events After an Acute Coronary Event Remains High, Especially During the First Year, Despite Revascularization.

INTRODUCTION AND OBJECTIVES: There is little information on the incidence and predictors of infarction, stroke, or cardiovascular death after acute coronary syndrome. We investigated these aspects and developed tools for predicting these events according to the time of their occurrence. METHODS: A retrospective study was conducted of 4858 patients who survived an acute coronary event. We analyzed the incidence and predictors of acute myocardial infarction, stroke, or cardiovascular death during the first year (n=4858) vs successive years (n=4345 patients free of composite events during the first year). RESULTS: There were 329 events in the first year (cumulative incidence function: 7.3% person-years) and 616 in successive years (21.5% person-years; follow-up 4.9±2.4 years). The risk of events during the first year per tertile was 2.5% person-years in the low-risk tertile (< 3 points), 4.8% person-years in the intermediate-risk tertile (3-6 points), and 15.5% person-years in the high-risk tertile (> 6 points) (P<.001). The risk of events in the cohort that had a combined event in successive years increased from 10.7% person-years in the low-risk tertile (< 3 points) to 40.3% person-years in the high-risk tertile (> 6 points) (P<.001). The 2 scales showed the following predictive indexes: C statistic, 0.74 and 0.69, respectively; P (Hosmer-Lemeshow test)≥0.44 CONCLUSION: The risk of recurrence of cardiovascular events remains high after acute coronary syndrome. The level of risk can be easily quantified with acceptable predictive ability.

Evaluation of SAMe-TT2R2 risk score for predicting the quality of anticoagulation control in a real-world cohort of patients with non-valvular atrial fibrillation on vitamin-K antagonists.

AIMS: Clinicians need to get better at identifying patients who would have poor quality of anticoagulation control with vitamin-K antagonists (VKAs). We assessed the predictive ability of SAMe-TT2R2 score, recently conceived for the prior purpose, and examined its relationship with major bleeding, thromboembolic (TE) complications, and death. METHODS AND RESULTS: Retrospectively, 911 consecutive patients with non-valvular atrial fibrillation (NVAF) started on VKAs within 8 months were studied. The percentage of international normalized ratios in therapeutic range (PINRR) at different levels was used as a metric of anticoagulation quality. We also tested the SAMe-TT2R2 predictability for major bleeding, TE complications, and death throughout 10 ± 3 months. The PINRR decreased from 62% at zero point to 53% at ≥4 points of SAMe-TT2R2. 82.1% of patients who achieved PINRR ≥ 70% had 0 or 1 point of SAMe-TT2R2. SAMe-TT2R2 performed significantly better at PINRR 70% than at 65 and 60% (c-statistic = 0.60 vs. c-statistic = 0.56). The calibration of SAMe-TT2R2 was excellent (Hosmer-Lemeshow test P-values ≥ 0.6). SAMe-TT2R2 showed significant association with the composite outcome of major bleeding, TE complications, and death [n = 98; hazard ratio (HR) = 1.32; 95% confidence interval (CI) 1.08-1.60]; the c-statistic was 0.57 (95% CI: 0.51-0.62) and P = 0.03. As individual outcomes, SAMe-TT2R2 was significantly associated with death (n = 60; HR = 1.3; 95% CI: 1.03-1.69), but not with either major bleeding (n = 30; HR = 1.2; 95% CI: 0.85-1.76) or TE complications (n = 15; HR = 1.01; 95% CI: 0.58-1.77). CONCLUSION: Among NVAF patients, SAMe-TT2R2 could represent a useful clinical tool to identify patients who would have poor quality of anticoagulation control with VKAs. SAMe-TT2R2 successfully predicts the composite outcome of major bleeding, TE complications, and death.

Long-term Prognosis of Patients With Non-ST-segment Elevation Acute Myocardial Infarction and Coronary Arteries Without Significant Stenosis.

INTRODUCTION AND OBJECTIVES: There is debate regarding the prognostic significance of the absence of significant coronary lesions in patients with non-ST-segment elevation acute myocardial infarction. We investigated long-term prognosis in a contemporary cohort of these patients. METHODS: Retrospective observational study of 5203 patients with acute coronary syndrome. Propensity score matching was used to create 2 groups of 367 patients with non-ST-segment elevation acute myocardial infarction matched by the absence or presence of significant coronary lesions. In the matched cohort, we determined the impact of the absence of significant coronary lesions on mortality or readmission for acute coronary syndrome for 4.8 (2.6) years after discharge. RESULTS: Mortality or readmission for acute coronary syndrome was lower among patients without significant lesions (26.4% vs 32.7%; P = .09). Mortality in both groups was 19.1%. In contrast, patients without significant lesions had a lower incidence of readmission for acute coronary syndrome (2.0/100 vs 3.9/100 person-years; P = .003). The incidence of mortality or readmission for acute coronary syndrome was similar in patients without significant lesions and those with significant 1-vessel disease (26.4% vs 27.5%; P = .19), but lower than that in patients with 2-vessel disease (37.8%; P = .007) and 3-vessel disease or left main coronary artery disease (41.1%; P = .002). CONCLUSIONS: Patients with non-ST-segment elevation acute myocardial infarction and coronary arteries without significant lesions have similar long-term mortality but lower readmission rates for acute coronary syndrome than patients with significant lesions. Mortality or readmission for acute coronary syndrome is similar in patients without significant lesions and patients with 1-vessel disease, but lower than in patients with disease in 2 or more vessels.

Relation of contrast induced nephropathy to new onset atrial fibrillation in acute coronary syndrome.

Chronic renal failure has been described as a risk factor for the development of atrial fibrillation (AF). The aim of this study was to examine the association between contrast-induced nephropathy (CIN) and new-onset AF in patients with acute coronary syndromes. A total of 1,520 consecutive patients (mean age 67.1 ± 12.7 years) with acute coronary syndromes (34.4% with ST-segment elevation myocardial infarctions) who underwent coronary angiography were studied. CIN was defined as an increase in serum creatinine of 0.5 mg/dl within 72 hours of contrast exposure. The independent effect of AF history (chronic or paroxysmal AF before catheterization) on the development of CIN, as well as the independent effect of CIN on the development of new-onset AF (after catheterization, during the in-hospital phase), were tested by using different logistic regression models. One hundred thirty-nine patients (9.1%) had histories of AF before catheterization (60 with paroxysmal and 79 with chronic AF), and 56 (4.1%) developed new-onset AF after catheterization. Eighty-seven patients (5.7%) had CIN. AF history was a predictor of CIN in univariate analysis (odds ratio 2.19, 95% confidence interval 1.22 to 3.95, p = 0.007) but not in multivariate analysis, after adjusting for confounding variables (odds ratio 1.69, 95% confidence interval 0.89 to 3.22, p = 0.111). In contrast, those with CIN had an increased prevalence of new-onset AF (15.3% vs 3.4%, p <0.001). After adjusting for those variables associated with new-onset AF in the univariate analysis, CIN continued to show a significant association with new-onset AF, with a twofold increased risk (odds ratio 2.45, 95% confidence interval 1.07 to 5.64, p = 0.035). In conclusion, the development of CIN is an independent predictor of new-onset AF in the context of acute coronary syndromes.

Prognostic Benefit of Beta-blockers After Acute Coronary Syndrome With Preserved Systolic Function. Still Relevant Today?

INTRODUCTION AND OBJECTIVES: The scientific evidence for using beta-blockers after acute coronary syndrome stems from studies conducted in the days before coronary revascularization and in patients with ventricular dysfunction. The aim of this study was to analyze the current long-term prognostic benefit of beta-blockers in patients with acute coronary syndrome and preserved left ventricular ejection fraction. METHODS: We conducted a retrospective cohort study of 3236 patients with acute coronary syndrome and left ventricular ejection fraction ≥ 50%. We performed a propensity-matched analysis to draw up two groups of 555 patients paired according to whether or not they had been treated with beta-blockers. The prognostic value of beta-blockers to predict mortality during follow-up was analyzed using Cox regression. RESULTS: During the follow-up (median, 5.2 years), 506 patients (15.6%) died. Patients treated with beta-blockers (n=2277 [70.4%]) had a lower mortality rate (11.6% vs 25.2%; P<.001). After propensity score matching, we found that mortality during follow-up was still lower in the beta-blocker group (14.4% vs 18.9%; P=.020). Therefore, this treatment was an independent protective factor after adjusting for confounding variables in the multivariate Cox regression analysis (hazard ratio=0.64; 95% confidence interval, 0.48-0.87; P=.004). CONCLUSIONS: Beta-blocker treatment in patients with acute coronary syndrome and preserved left ventricular ejection fraction is associated with lower long-term mortality.