Perceval-S over time. Clinical outcomes after ten years of usage.

BACKGROUND: Perceval-S has become a reliable and commonly used option in surgical aortic valve replacement (AVR) since its first implantation in humans 15 years ago. Despite the fact that this aortic valve has been proven efficient enough in the short and mid-term period, there is still lack of evidence for the long-term outcomes. MATERIALS AND METHODS: This is an observational retrospective study in a high-volume cardiovascular center. Pertinent data were collected for all the patients in whom Perceval-S was implanted from 2013 to 2020. RESULTS: The total number of patients was 205 with a mean age 76.4 years. Mean survival time was 5.5 years (SE = 0.26). The overall survival probability of patients undergoing aortic valve replacement with Perceval-S at 6 months was 91.0% (Standard Error SE = 2.0%), at one year 88.4% (SE = 2.3%) and at 5-years 64.8% (SE = 4.4%). A detrimental cardiac event leading to death was the probable cause of death in 35 patients (55.6%). The initiation of Transcatheter Aortic Valve Replacement (TAVR) program in our center in 2017 was associated with a decline in the number of very high-risk patients treated with sutureless bioprosthesis. This fact is demonstrated by the significant shift towards lower surgical risk cases, as median Euroscore II was reduced from 5,550 in 2016 to 3,390 in 2020. Mini sternotomy was implemented in 79,5% of cases favoring less invasive approach. Low incidence of reinterventions, patient prosthesis mismatch and structural valve degeneration was detected. CONCLUSIONS: The survival rate after aortic valve replacement with implantation of Perceval-S is satisfactory in the long-term follow-up. Cases of bioprosthesis dysfunction were limited. Mini sternotomy was used in the majority of cases. TAVR initiation program impacted on the proportion of patients treated with Perceval-S with reduction of high-risk patients submitted to surgery.

Epicardial Adipose Tissue and Atrial Fibrillation Recurrence following Catheter Ablation: A Systematic Review and Meta-Analysis.

(1)Introduction: Catheter ablation has become a cornerstone for the management of patients with atrial fibrillation (AF). Nevertheless, recurrence rates remain high. Epicardial adipose tissue (EAT) has been associated with AF pathogenesis and maintenance. However, the literature has provided equivocal results regarding the relationship between EAT and post-ablation recurrence.(2) Purpose: to investigate the relationship between total and peri-left atrium (peri-LA) EAT with post-ablation AF recurrence. (3) Methods: major electronic databases were searched for articles assessing the relationship between EAT, quantified using computed tomography, and the recurrence of AF following catheter ablation procedures. (4) Results: Twelve studies (2179 patients) assessed total EAT and another twelve (2879 patients) peri-LA EAT. Almost 60% of the included patients had paroxysmal AF and recurrence was documented in 34%. Those who maintained sinus rhythm had a significantly lower volume of peri-LA EAT (SMD: -0.37, 95%; CI: -0.58-0.16, I2: 68%). On the contrary, no significant difference was documented for total EAT (SMD: -0.32, 95%; CI: -0.65-0.01; I2: 92%). No differences were revealed between radiofrequency and cryoenergy pulmonary venous isolation. No publication bias was identified. (5) Conclusions: Only peri-LA EAT seems to be predictive of post-ablation AF recurrence. These findings may reflect different pathophysiological roles of EAT depending on its location. Whether peri-LA EAT can be used as a predictor and target to prevent recurrence is a matter of further research.

Efficacy, Safety and Feasibility of Superior Vena Cava Isolation in Patients Undergoing Atrial Fibrillation Catheter Ablation: An Up-to-Date Review.

Pulmonary vein isolation (PVI) is the cornerstone in atrial fibrillation (AF) ablation; yet, the role of arrhythmogenic superior vena cava (SVC) is increasingly recognized and different ablation strategies have been employed in this context. SVC can act as a trigger or perpetuator of AF, and its significance might be more pronounced in patients undergoing repeated ablation. Several cohorts have examined efficacy, safety and feasibility of SVC isolation (SVCI) among AF patients. The majority of these studies explored as-needed SVCI during index PVI, and only a minority of them included repeated ablation subjects and non-radiofrequency energy sources. Studies of heterogeneous design and intent have explored both empiric and as-needed SVCI on top of PVI and reported inconclusive results. These studies have largely failed to demonstrate any clinical benefit in terms of arrhythmia recurrence, although safety and feasibility are undisputable. Mixed population demographics, small number of enrollees and short follow-up are the main limitations. Procedural and safety data are comparable between empiric SVCI and as-needed SVCI, and some studies suggested that empiric SVCI might be associated with reduced AF recurrences in paroxysmal AF patients. Currently, no study has compared different ablation energy sources in the setting of SVCI, and no randomized study has addressed as-needed SVCI on top of PVI. Furthermore, data regarding cryoablation are still in their infancy, and regarding SVCI in patients with cardiac devices more safety and feasibility data are needed. PVI non-responders, patients undergoing repeated ablation and patients with long SVC sleeves could be potential candidates for SVCI, especially via an empiric approach. Although many technical aspects remain unsettled, the major question to answer is which clinical phenotype of AF patients might benefit from SVCI?

Atrial strain and occult atrial fibrillation in cryptogenic stroke patients: a systematic review and meta-analysis.

BACKGROUND: Cryptogenic stroke (CS) remains a significant cause of morbidity. Failure to identify the underlying pathology increases the rate of recurrence. Atrial fibrillation (AF) seems to be responsible for a substantial proportion of CS. Thus, there is an unmet need to identify and properly treat those with silent AF. PURPOSE: To investigate the association between left atrial strain and newly diagnosed AF in CS patients. OBJECTIVES: We searched major electronic databases for articles assessing the relationship between either peak left atrial longitudinal (PALS) or peak contractile (PACS) strain-quantified using speckle tracking echocardiography-and the incidence of occult AF during the diagnostic work-up of CS patients. RESULTS: Eleven studies (two thousand and eighty-one patients) were analyzed. Incidence of occult AF was 19%. Both PALS and PACS were significantly lower in patients with newly diagnosed AF (MD - 8.6%, 95%CI - 10.7 to - 6.4, I2 86.4% and MD - 5.5, 95%CI - 6.8 to - 4.2, I2 80.8%). According to the diagnostic accuracy meta-analysis, PALS < 20% present 71% (95%CI 47-87%) sensitivity and 71% (95%CI 60-81%) specificity for the diagnosis of occult AF, assuming a prevalence of 20%. The corresponding values for PACS < 11% are 83% (95%CI 57-94%) and 78% (95%CI 56-91%). CONCLUSION: Both PALS and PACS are significantly lower in patients with CS and silent AF. It seems that the cut-off values mentioned above could help physicians in identifying patients who may benefit more from prolonged rhythm monitoring. More studies are needed to confirm these findings.

Advances in Heart Failure with Preserved Ejection Fraction Management - The role of Sacubitril-Valsartan, Pirfenidone, Spironolactone and Empagliflozin: Is Success a Series of Small Victories?

BACKGROUND: Heart failure with preserved ejection fraction (HFpEF) is a syndrome characterized by marked heterogeneity in comorbidities and etiopathology substrates, leading to a diverse range of clinical manifestations and courses. Treatment options have been extremely limited and up to this day, there are virtually no pharmaceutical agents proven to reduce mortality in these patients. OBJECTIVE: The primary objective of this narrative review is to critically summarize existing evidence regarding the use of Angiotensin Receptor-Neprilysin Inhibitor (ARNI), spironolactone, pirfenidone and empagliflozin in HFpEF. METHODS: Medline (via PubMed) and Scopus were searched - from inception up to May 2022- using adequately selected keywords. Additional hand-search was also performed using the references of the articles identified as relevant (snowball strategy). RESULTS: Angiotensin Receptor-Neprilysin Inhibitor (ARNI) and spironolactone, despite being very successful in HFrEF, did not do well in clinical trials of HFpEF, although there appear to be certain subsets of patients who may derive benefit. Data regarding pirfenidone are limited and come from small trials; as a result, it would be premature to draw firm conclusions, although it seems improbable that this agent will ever become a mainstay in the general population of HPpEF patients, while there may be a niche for the drug in individuals with comorbidities associated with an intense fibrotic activity. Finally, empagliflozin, largely welcomed as the first agent to have a "positive" randomized clinical trial in HFpEF, does not seem to evade the general pattern of reduced hospitalizations for HF with no substantial effect on mortality, seen in ARNI and spironolactone HFpEF trials. CONCLUSION: Recent research in drug treatment for HFpEF has resulted in an overall mixed picture, with trials showing potential benefits from certain classes of drugs, such as sodium-glucose co-transporter 2 inhibitors, and no benefit from other drugs, which have shown to be effective in patient with reduced ejection fraction. However, small steps may be the way to go in HFpEF, and success is sometimes just a series of small victories.

Weekly physical activity and incident atrial fibrillation in females - A dose-response meta-analysis.

BACKGROUND: For years, physical activity (PA) has been considered a mixed blessing in terms of the risk of incident atrial fibrillation (AF). Previous analyses have had equivocal results regarding the cut-off of PA level beyond which AF risk increases, if such a limit really does exist. Data regarding females in particular have been scarce. METHODS: We performed a dose-response meta-analysis to investigate the relationship between weekly PA and the risk for AF in females. Major electronic databases were searched for studies assessing the association between leisure time PA and the risk for incident AF in females from the general population. The linearity of the dose-response curve was assessed using the restricted cubic spline model. RESULTS: A total of 15 studies, which involved 1,821,422 females, were included in the final analysis. AF incidence was 3.7%. Dose-response analysis revealed an inverse nonlinear relationship between weekly PA and the risk for incident AF (p for linearity <0.0001). No significant heterogeneity was documented (I2 = 37%). Cautious interpretation is needed for PA exceeding 50 metabolic equivalents of task- hours per week (METs- h/w), due to limited available data for these high levels of PA. CONCLUSION: According to this analysis, physicians can safely advise females to perform up to 50METs- h/w of moderate or vigorous PA, to reduce the risk for future AF. Interestingly, significant benefit can be attained even at low levels of regular weekly PA.

Different venous approaches for implantation of cardiac electronic devices. A network meta-analysis.

OBJECTIVES: Many of the complications arising from cardiac device implantation are associated to the venous access used for lead placement. Previous analyses reported that cephalic vein cutdown (CVC) is safer but less effective than subclavian vein puncture (SVP). However, comparisons between these techniques and axillary vein puncture (AVP) - guided either by ultrasound or fluoroscopy - are lacking. Thus, we aimed to compare safety and efficacy of these approaches. METHODS: We searched for articles assessing at least two different approaches regarding the incidence of pneumothorax and/or lead failure (LF). When available, bleeding and infectious complications as well as procedural success were analyzed. A frequentist random effects network meta-analysis model was adopted. RESULTS: Thirty-six studies were analyzed. Most articles assessed SVP versus CVC. Compared to SVP, both CVC and AVP were associated with reduced odds of pneumothorax (OR: 0.193, 95%CI: 0.136-0.275 and OR: 0.128, 95%CI: 0.050-0.329; respectively) and LF (OR: 0.63, 95%CI: 0.406-0.976 and OR: 0.425, 95%CI: 0.286-0.632; respectively). No significant differences between AVP and CVC were demonstrated. Limited data suggests no major impact of different approaches on infectious and bleeding complications. Initial CVC approach required significantly more often an alternate/additional venous access for lead placement, compared to both AVP and SVP. No differences between these two were identified. CONCLUSION: Both AVP and CVC seem to decrease incident pneumothorax and LF, compared to SVP. Initial AVP approach seems to decrease the need of alternate venous access, compared to CVC. These results suggest that AVP should be further clinically tested.

Alcohol Consumption and the Risk of Incident Atrial Fibrillation: A Meta-Analysis.

Alcohol consumption is a known, modifiable risk factor for incident atrial fibrillation (AF). However, it remains unclear whether the protective effect of moderate alcohol consumption-that has been reported for various cardiovascular diseases also applies to the risk for new-onset AF. The purpose of this meta-analysis was to evaluate the role of different drinking patterns (low: <14 grams/week; moderate: <168 grams/week; and heavy: >168 grams/week) on the risk for incident AF. Major electronic databases were searched for observational cohorts examining the role of different drinking behaviors on the risk for incident AF. We analyzed 16 studies (13,044,007 patients). Incident AF rate was 2.3%. Moderate alcohol consumption significantly reduced the risk for new-onset AF when compared to both abstainers (logOR: -0.20; 95%CI: -0.28--0.12; I2: 96.71%) and heavy drinkers (logOR: -0.28; 95%CI: -0.37--0.18; I2: 95.18%). Heavy-drinking pattern compared to low also increased the risk for incident AF (logOR: 0.14; 95%CI: 0.01-0.2; I2: 98.13%). Substantial heterogeneity was noted, with more homogeneous results documented in cohorts with follow-up shorter than five years. Our findings suggest a J-shaped relationship between alcohol consumption and incident AF. Up to 14 drinks per week seem to decrease the risk for developing AF. Because of the substantial heterogeneity observed, no robust conclusion can be drawn. In any case, our results suggest that the association between alcohol consumption and incident AF is far from being a straightforward dose-response effect.

The role of left atrial peak systolic strain in atrial fibrillation recurrence after catheter ablation. A systematic review and meta-analysis.

BACKGROUND: This systematic review and meta-analysis was performed to assess the prognostic role of left atrial peak systolic longitudinal strain (LA-PLSsys) as a predictor of atrial fibrillation (AF) recurrence after catheter ablation. METHODS: We systematically searched major electronic databases and grey literature for studies assessing the role of pre-ablation LA-PLSsys, measured in at least two segments, in post-ablation AF recurrence, after a follow-up period of at least 6 months. RESULTS: Seventeen eligible studies were included, resulting in 1704 patients (68.6% men) with a pooled mean age of 59.9 ± 10.6 years, 65.9% with paroxysmal AF. Recurrence occurred in 32.7% of patients. Those without recurrence had significantly higher LA-PLSsys (pooled mean ± SD: 22.22 ± 10.64%, weighted mean difference: 5.43%, 95%CI: 4.03-6.84%, I2: 82.7%). Subgroup analysis revealed that the methodology used (echocardiographic view and segments assessed), was a significant source of heterogeneity (p = 0.02). Meta-regression analysis demonstrated that the effect size was inversely related to the baseline LA volume index (p = 0.004), while concerns are also raised about patients with extremely high/low pre-ablation LA strain. CONCLUSIONS: Pre-ablation LA-PLSsys seems to be a useful predictor of post-ablation AF recurrence, that could optimise patients selection. Nevertheless, the substantial heterogeneity that was noted may limit its clinical use. Further investigation using a uniform methodological assessment technique is required to derive a reference range, with adequate positive and negative predictive value for recurrence.

The prognostic role of late gadolinium enhancement on cardiac magnetic resonance in patients with nonischemic cardiomyopathy and reduced ejection fraction, implanted with cardioverter defibrillators for primary prevention. A systematic review and meta-analysis.

BACKGROUND: Previous studies suggest that late gadolinium enhancement (LGE) on cardiac magnetic resonance (CMR) is associated with arrhythmic events in patients with nonischemic cardiomyopathy (NICM), while others have questioned the role of left ventricular ejection fraction (LVEF) as a sole predictor of future events. OBJECTIVES: To evaluate the role of LGE on CMR in identifying patients with NICM and reduced LVEF for whom a benefit from defibrillator implantation for primary prevention is not anticipated, thus they are mainly exposed to potential risks. METHODS: Major electronic databases were searched for studies reporting the incidence of appropriate device therapy (ADT), sudden cardiac death (SCD), and cardiac death based on the presence of LGE on CMR, among patients with NICM and reduced LVEF, implanted with a cardioverter defibrillator for primary prevention. RESULTS: Eleven studies (1652 patients, 947 with LGE) were included in the final analysis. LGE presence was strongly associated with ADT (logOR: 1.95, 95%CI: 1.21-2.69) and cardiac death (logOR: 0.91, 95%CI: 0.14-1.68), but not with SCD (logOR: 0.26, 95%CI: -1.09-1.6). Diagnostic accuracy analysis demonstrated that contrast enhancement is a sensitive marker of future ADT and cardiac death (93%, 95%CI: 85.8-96.7%; 82.9%, 95%CI: 70.6-90.7%; respectively), with moderate specificity ( 44%, 95%CI: 27.2-62.6%; 37.7%, 95%CI: 23.4-54.6%; respectively). CONCLUSION: LGE is a highly sensitive predictor of ADT and cardiac death in NICM patients implanted with a defibrillator for primary prevention. However, due to moderate specificity, derivation of a cutoff with adequate predictive values and probably a multifactorial approach are needed to improve discrimination of patients who will not benefit from ICDs.

A stand-alone structured educational programme after myocardial infarction: a randomised study.

BACKGROUND: Acute myocardial infarction (MI) is a major clinical manifestation of coronary artery disease. Post-MI morbidity and mortality can be reduced by lifestyle changes and aggressive risk factor modification. These changes can be applied more effectively if the patient is actively involved in the process. The hypothesis of this study was that an educational programme in post-MI patients could lead to reduced incidence of cardiovascular events. METHODS: Post-MI patients were prospectively randomised into two groups. Patients in the intervention arm were scheduled to attend an 8-week-long educational programme on top of usual treatment, while controls received optimal treatment. The primary endpoint was the composite of all-cause death, MI, cerebrovascular event and unscheduled hospitalisation for cardiovascular causes. Endpoint adjudication was blinded. RESULTS: 329 patients (238 men) were included, with a mean follow-up time of 17±4 months. In the primary analysis, mean primary end point-free survival time was 597 days (95% CI 571 to 624) in controls, compared with 663 days (95% CI 638 to 687) in the intervention group (p<0.001). The HR in the univariate Cox regression analysis was 0.48 (95% CI 0.32 to 0.73; p=0.001). The raw rates of the primary endpoint were 20.8% (6 deaths, 13 MIs, 2 strokes and 14 hospitalisations) vs 36.6% (8 deaths, 22 MIs, 7 strokes and 22 hospitalisations), respectively (OR 0.46, 95% CI 0.28 to 0.74; p=0.002). CONCLUSION: These results suggest that a relatively short adult education programme offered to post-MI patients has beneficial effects, resulting in reduced risk of cardiovascular events. TRIAL REGISTRATION NUMBER: NCT04007887.

"Missing" acute coronary syndrome hospitalizations during the COVID-19 era in Greece: Medical care avoidance combined with a true reduction in incidence?

BACKGROUND: Reports from countries severely hit by the COVID-19 pandemic suggest a decline in acute coronary syndrome (ACS)-related hospitalizations. The generalizability of this observation on ACS admissions and possible related causes in countries with low COVID-19 incidence are not known. HYPOTHESIS: ACS admissions were reduced in a country spared by COVID-19. METHODS: We conducted a nationwide study on the incidence rates of ACS-related admissions during a 6-week period of the COVID-19 outbreak and the corresponding control period in 2019 in Greece, a country with strict social measures, low COVID-19 incidence, and no excess in mortality. RESULTS: ACS admissions in the COVID-19 (n = 771) compared with the control (n = 1077) period were reduced overall (incidence rate ratio [IRR]: 0.72, P < .001) and for each ACS type (ST-segment elevation myocardial infarction [STEMI]: IRR: 0.76, P = .001; non-STEMI: IRR: 0.74, P < .001; and unstable angina [UA]: IRR: 0.63, P = .002). The decrease in STEMI admissions was stable throughout the COVID-19 period (temporal correlation; R2 = 0.11, P = .53), whereas there was a gradual decline in non-STEMI/UA admissions (R2 = 0.75, P = .026) following the progressively stricter social measures. During the COVID-19 period, patients admitted with ACS presented more frequently with left ventricular systolic impairment (22.2 vs 15.5% control period; P < .001). CONCLUSIONS: We observed a reduction in ACS hospitalizations during the COVID-19 outbreak in a country with strict social measures, low community transmission, and no excess in mortality. Medical care avoidance behavior is an important factor for these observations, while a true reduction of the ACS incidence due to self-isolation/quarantining may have also played a role.

Usefulness of a Structured Adult Education Program in Modifying Markers of Cardiovascular Risk After Acute Myocardial Infarction.

Patient involvement in therapeutic strategies leading to lifestyle changes and increasing adherence to beneficial treatment is important for high risk coronary artery disease patients. The hypothesis of the present substudy was that a program of education specifically structured to educate postmyocardial infarction patients would lead to measurable differences in specific indices of cardiovascular risk. Post-MI patients were randomly assigned to 2 groups. Patients in the intervention arm attended an 8-week long educational program in addition to usual treatment and controls received standard treatment. Low-density lipoprotein cholesterol, systolic blood pressure, body-mass index, and glycosylated hemoglobin were assessed at baseline and at 12 months (values are reported as median [interquartile range]). One hundred ninety-eight consecutively randomized patients were included in the present substudy. The median change in Low-density lipoprotein cholesterol was -54 (-45 to [-62]) mg/dl in the intervention group as compared with -35 (-28 to [-43]) mg/dl in controls (p <0.001). Systolic blood pressure change was -7.5 (-15.3 to 0.3) mm Hg and -3.0 (-11.8 to 2.8) mm Hg, respectively (p = 0.011). The median change in body-mass index was 0.0 (-3.0 to 3.0) kg/m2 as compared with 2.0 (-1.0 to 3.9) kg/m2, respectively (p = 0.002). The reduction in glycosylated hemoglobin was significant in both groups with a median absolute change of -0.29 (-1.11 to 0.09) % in the intervention group and -0.24 (-0.69 to 0.06) % in controls (p = 0.168). If only diabetic patients were considered, the change was -0.65 (-1.3 to [-0.23]) % in the intervention group versus -0.41 (-0.74 to [-0.07]) % in controls (p = 0.021). In conclusion, a relatively short patient education program may have long-lasting effects on established modifiable markers of cardiovascular risk.