A Prospective, Multicenter, Real-World Registry of Coronary Lithotripsy in Calcified Coronary Arteries: The REPLICA-EPIC18 Study.

BACKGROUND: Intravascular lithotripsy (IVL) has demonstrated effectiveness in the treatment of calcified lesions in selected patients with stable coronary disease. OBJECTIVES: The authors sought to assess the performance of coronary IVL in calcified coronary lesions in a real-life, all comers, setting. METHODS: The REPLICA-EPIC18 study prospectively enrolled consecutive patients treated with IVL in 26 centers in Spain. An independent core laboratory performed the angiographic analysis and event adjudication. The primary effectiveness endpoint assessed procedural success (successful IVL delivery, final diameter stenosis <20%, and absence of in-hospital major adverse cardiovascular events [MACE]). The primary safety endpoint measured freedom from MACE at 30 days. A predefined substudy compared outcomes between acute coronary syndrome (ACS) and chronic coronary syndrome (CCS) patients. RESULTS: A total of 426 patients (456 lesions) were included, 63% of the patients presenting with ACS. IVL delivery was successful in 99% of cases. Before IVL, 49% of lesions were considered undilatable. The primary effectiveness endpoint was achieved in 66% of patients, with similar rates among CCS patients (68%) and ACS patients (65%). Likewise, there were no significant differences in angiographic success after IVL between CCS and ACS patients. The rate of MACE at 30 days (primary safety endpoint) was 3% (1% in CCS and 5% in ACS patients [P = 0.073]). CONCLUSIONS: Coronary IVL proved to be a feasible and safe procedure in a "real-life" setting, effectively facilitating stent implantation in severely calcified lesions. Patients with ACS on admission showed similar angiographic success rates but showed a trend toward higher 30-day MACE compared with patients with CCS. (REPLICA-EPIC18 study [Registry of Coronary Lithotripsy in Spain]; NCT04298307).

Coronary Obstruction After Transcatheter Aortic Valve Replacement: Insights From the Spanish TAVI Registry.

BACKGROUND: Coronary obstruction (CO) following transcatheter aortic valve replacement (TAVR) is a life-threatening complication, scarcely studied. OBJECTIVES: The authors analyzed the incidence of CO after TAVR, presentation, management, and in-hospital and 1-year clinical outcomes in a large series of patients undergoing TAVR. METHODS: Patients from the Spanish TAVI (Transcatheter Aortic Valve Implantation) registry who presented with CO in the procedure, during hospitalization or at follow-up were included. Computed tomography (CT) risk factors were assessed. In-hospital, 30-day, and 1-year all-cause mortality rates were analyzed and compared with patients without CO using logistic regression models in the overall cohort and in a propensity score-matched cohort. RESULTS: Of 13,675 patients undergoing TAVR, 115 (0.80%) presented with a CO, mainly during the procedure (83.5%). The incidence of CO was stable throughout the study period (2009-2021), with a median annual rate of 0.8% (range 0.3%-1.3%). Preimplantation CT scans were available in 105 patients (91.3%). A combination of at least 2 CT-based risk factors was less frequent in native than in valve-in-valve patients (31.7% vs 78.3%; P < 0.01). Percutaneous coronary intervention was the treatment of choice in 100 patients (86.9%), with a technical success of 78.0%. In-hospital, 30-day, and 1-year mortality rates were higher in CO patients than in those without CO (37.4% vs 4.1%, 38.3% vs 4.3%, and 39.1% vs 9.1%, respectively; P < 0.001). CONCLUSIONS: In this large, nationwide TAVR registry, CO was a rare, but often fatal, complication that did not decrease over time. The lack of identifiable predisposing factors in a subset of patients and the frequently challenging treatment when established may partly explain these findings.

Prognostic implications of left ventricular systolic dysfunction in patients with spontaneous coronary artery dissection.

AIMS: Spontaneous coronary artery dissection (SCAD) is a relatively infrequent cause of acute coronary syndrome. Clinical features, angiographic findings, management, and outcomes of SCAD patients who present reduced left ventricular ejection fraction (LVEF) remain unknown. METHODS AND RESULTS: The Spanish multicentre prospective SCAD registry (NCT03607981), included 389 consecutive patients with SCAD. In 348 of these patients, LVEF could be assessed by echocardiography during the index admission. Characteristics and outcomes of patients with preserved LVEF (LVEF ≥50%, n = 295, 85%) were compared with those with reduced LVEF (LVEF <50%, n = 53, 15%). Mean age was 54 years and 90% of patients in both groups were women. The most frequent clinical presentation in patients with reduced LVEF was ST-segment elevation myocardial infarction (STEMI) (62% vs. 36%, P < 0.001), especially anterior STEMI. Proximal coronary segment and multi-segment involvement were also significantly more frequent in these patients. No differences were found on initial revascularization between groups. Patients with reduced LVEF significantly received more often neurohormonal antagonist therapy, and less frequently aspirin. In-hospital events were more frequent in these patients (13% vs. 5%, P = 0.01), with higher rates of death, cardiogenic shock, ventricular arrhythmia, and stroke. During a median follow-up of 28 months, the occurrence of a combined adverse event did not statistically differ between the two groups (19% vs. 12%, P = 0.13). However, patients with reduced LVEF had higher mortality (9% vs. 0.7%, P < 0.001) and readmission rates for heart failure (HF) (4% vs. 0.3%, P = 0.01). CONCLUSION: Patients with SCAD and reduced LVEF show differences in clinical characteristics and angiographic findings compared with SCAD patients with preserved LVEF. Although these patients receive specific medications at discharge, they had higher mortality and readmission rates for HF during follow-up.

Age-Related Effects of COVID-19 Pandemic on Mechanical Reperfusion and 30-Day Mortality for STEMI: Results of the ISACS-STEMI COVID-19 Registry.

BACKGROUND: The constraints in the management of patients with ST-segment elevation myocardial infarction (STEMI) during the COVID-19 pandemic have been suggested to have severely impacted mortality levels. The aim of the current analysis is to evaluate the age-related effects of the COVID-19 pandemic on mechanical reperfusion and 30-day mortality for STEMI within the registry ISACS-STEMI COVID-19. METHODS: This retrospective multicenter registry was performed in high-volume PPCI centers on four continents and included STEMI patients undergoing PPCI in March-June 2019 and 2020. Patients were divided according to age (< or ≥75 years). The main outcomes were the incidence and timing of PPCI, (ischemia time longer than 12 h and door-to-balloon longer than 30 min), and in-hospital or 30-day mortality. RESULTS: We included 16,683 patients undergoing PPCI in 109 centers. In 2020, during the pandemic, there was a significant reduction in PPCI as compared to 2019 (IRR 0.843 (95%-CI: 0.825-0.861, p < 0.0001). We found a significant age-related reduction (7%, p = 0.015), with a larger effect on elderly than on younger patients. Furthermore, we observed significantly higher 30-day mortality during the pandemic period, especially among the elderly (13.6% vs. 17.9%, adjusted HR (95% CI) = 1.55 [1.24-1.93], p < 0.001) as compared to younger patients (4.8% vs. 5.7%; adjusted HR (95% CI) = 1.25 [1.05-1.49], p = 0.013), as a potential consequence of the significantly longer ischemia time observed during the pandemic. CONCLUSIONS: The COVID-19 pandemic had a significant impact on the treatment of patients with STEMI, with a 16% reduction in PPCI procedures, with a larger reduction and a longer delay to treatment among elderly patients, which may have contributed to increase in-hospital and 30-day mortality during the pandemic.

Gender Difference in the Effects of COVID-19 Pandemic on Mechanical Reperfusion and 30-Day Mortality for STEMI: Results of the ISACS-STEMI COVID-19 Registry.

BACKGROUND: Several reports have demonstrated the impact of the COVID-19 pandemic on the management and outcome of patients with ST-segment elevation myocardial infarction (STEMI). The aim of the current analysis is to investigate the potential gender difference in the effects of the COVID-19 pandemic on mechanical reperfusion and 30-day mortality for STEMI patients within the ISACS-STEMI COVID-19 Registry. METHODS: This retrospective multicenter registry was performed in high-volume primary percutaneous coronary intervention (PPCI) centers on four continents and included STEMI patients undergoing PPCIs in March-June 2019 and 2020. Patients were divided according to gender. The main outcomes were the incidence and timing of the PPCI, (ischemia time ≥ 12 h and door-to-balloon ≥ 30 min) and in-hospital or 30-day mortality. RESULTS: We included 16683 STEMI patients undergoing PPCIs in 109 centers. In 2020 during the pandemic, there was a significant reduction in PPCIs compared to 2019 (IRR 0.843 (95% CI: 0.825-0.861, p < 0.0001). We did not find a significant gender difference in the effects of the COVID-19 pandemic on the numbers of STEMI patients, which were similarly reduced from 2019 to 2020 in both groups, or in the mortality rates. Compared to prepandemia, 30-day mortality was significantly higher during the pandemic period among female (12.1% vs. 8.7%; adjusted HR [95% CI] = 1.66 [1.31-2.11], p < 0.001) but not male patients (5.8% vs. 6.7%; adjusted HR [95% CI] = 1.14 [0.96-1.34], p = 0.12). CONCLUSIONS: The COVID-19 pandemic had a significant impact on the treatment of patients with STEMI, with a 16% reduction in PPCI procedures similarly observed in both genders. Furthermore, we observed significantly increased in-hospital and 30-day mortality rates during the pandemic only among females. Trial registration number: NCT 04412655.

Changes in the Treatment Strategy Following Intracoronary Pressure Wire in a Contemporaneous Real-Life Cohort of Patients With Intermediate Coronary Stenosis. Results From a Nationwide Registry.

BACKGROUND: Intracoronary pressure wire is useful to guide revascularization in patients with coronary artery disease. AIMS: To evaluate changes in diagnosis (coronary artery disease extent), treatment strategy and clinical results after intracoronary pressure wire study in real-life patients with intermediate coronary artery stenosis. METHODS: Observational, prospective and multicenter registry of patients in whom pressure wire was performed. The extent of coronary artery disease and the treatment strategy based on clinical and angiographic criteria were recorded before and after intracoronary pressure wire guidance. 12-month incidence of MACE (cardiovascular death, non-fatal myocardial infarction or new revascularization of the target lesion) was assessed. RESULTS: 1414 patients with 1781 lesions were included. Complications related to the procedure were reported in 42 patients (3.0 %). The extent of coronary artery disease changed in 771 patients (54.5 %). There was a change in treatment strategy in 779 patients (55.1 %) (18.0 % if medical treatment; 68.8 % if PCI; 58.9 % if surgery (p < 0.001 for PCI vs medical treatment; p = 0.041 for PCI vs CABG; p < 0.001 for medical treatment vs CABG)). In patients with PCI as the initial strategy, the change in strategy was associated with a lower rate of MACE (4.6 % vs 8.2 %, p = 0.034). CONCLUSIONS: The use of intracoronary pressure wire was safe and led to the reclassification of the extent of coronary disease and change in the treatment strategy in more than half of the cases, especially in patients with PCI as initial treatment.

SARS-CoV-2 Positivity, Stent Thrombosis, and 30-day Mortality in STEMI Patients Undergoing Mechanical Reperfusion.

SARS-Cov-2 has been suggested to promote thrombotic complications and higher mortality. The aim of the present study was to evaluate the impact of SARS-CoV-2 positivity on in-hospital outcome and 30-day mortality in ST-segment elevation myocardial infarction (STEMI) patients undergoing primary percutaneous coronary intervention (PCI) enrolled in the International Survey on Acute Coronary Syndromes ST-segment elevation Myocardial Infarction (ISACS-STEMI COVID-19 registry. The 109 SARS-CoV-2 positive patients were compared with 2005 SARS-CoV-2 negative patients. Positive patients were older (P = .002), less often active smokers (P = .002), and hypercholesterolemic (P = .006), they presented more often later than 12 h (P = .037), more often to the hub and were more often in cardiogenic shock (P = .02), or requiring rescue percutaneous coronary intervention after failed thrombolysis (P < .0001). Lower postprocedural Thrombolysis in Myocardial Infarction 3 flow (P = .029) and more thrombectomy (P = .046) were observed. SARS-CoV-2 was associated with a significantly higher in-hospital mortality (25.7 vs 7%, adjusted Odds Ratio (OR) [95% Confidence Interval] = 3.2 [1.71-5.99], P < .001) in-hospital definite in-stent thrombosis (6.4 vs 1.1%, adjusted Odds Ratio [95% CI] = 6.26 [2.41-16.25], P < .001) and 30-day mortality (34.4 vs 8.5%, adjusted Hazard Ratio [95% CI] = 2.16 [1.45-3.23], P < .001), confirming that SARS-CoV-2 positivity is associated with impaired reperfusion, with negative prognostic consequences.

Impact of Smoking Status on Mortality in STEMI Patients Undergoing Mechanical Reperfusion for STEMI: Insights from the ISACS-STEMI COVID-19 Registry.

The so-called "smoking paradox", conditioning lower mortality in smokers among STEMI patients, has seldom been addressed in the settings of modern primary PCI protocols. The ISACS−STEMI COVID-19 is a large-scale retrospective multicenter registry addressing in-hospital mortality, reperfusion, and 30-day mortality among primary PCI patients in the era of the COVID-19 pandemic. Among the 16,083 STEMI patients, 6819 (42.3%) patients were active smokers, 2099 (13.1%) previous smokers, and 7165 (44.6%) non-smokers. Despite the impaired preprocedural recanalization (p < 0.001), active smokers had a significantly better postprocedural TIMI flow compared with non-smokers (p < 0.001); this was confirmed after adjustment for all baseline and procedural confounders, and the propensity score. Active smokers had a significantly lower in-hospital (p < 0.001) and 30-day (p < 0.001) mortality compared with non-smokers and previous smokers; this was confirmed after adjustment for all baseline and procedural confounders, and the propensity score. In conclusion, in our population, active smoking was significantly associated with improved epicardial recanalization and lower in-hospital and 30-day mortality compared with previous and non-smoking history.

Clinical Implications of the "Broken Line" Angiographic Pattern in Patients With Spontaneous Coronary Artery Dissection.

Spontaneous coronary artery dissection (SCAD) is a rare but increasingly recognized cause of acute myocardial infarction. Coronary angiography remains the best diagnostic tool; however, clinical suspicion and experience is required to interpret angiographic findings. This study sought to assess the clinical implications of the "broken line" (BKL) angiographic pattern in a large, nationwide, cohort of patients with SCAD. The Spanish SCAD registry (NCT03607981) prospectively enrolled consecutive patients with SCAD. All angiograms were centrally analyzed and the BKL pattern was systematically assessed. The BKL angiographic pattern was found in 64 of 389 patients (16%). Patients with the BKL appearance were more frequently female (97 vs 87%, p <0.05), presented more often as intramural hematoma (83 vs 58%, p <0.001), had longer lesions (47 ± 29 vs 36 ± 22 mm, p <0.01), and had severe tortuosity (25 vs 10%, p <0.01) but showed better initial coronary flow (thrombolysis in myocardial infarction flow 2.6 ± 0.8 vs 2.1 ± 1.2, p <0.01). Patients with BKL received more frequently conservative medical management (91 vs 76%, p <0.01). At late clinical follow-up (median 29 months, interquartile range 17 to 38) predefined adverse events (death, myocardial infarction, revascularization, recurrent SCAD, or stroke) occurred less frequently (3.5 vs 15%, p <0.05) in patients with the BKL appearance. The better clinical outcomes of patients in the BKL group persisted after adjusting for potential confounders (adjusted hazard ratio 0.2, 95% confidence interval 0.1 to 0.9, p <0.05). In conclusion, patients with SCAD presenting the BKL angiographic pattern are more frequently female and present more often as intramural hematoma with longer lesions and severe vessel tortuosity but have better coronary flow. Patients with the BKL morphology have a favorable prognosis (NCT03607981).

Impact of chronic obstructive pulmonary disease on short-term outcome in patients with ST-elevation myocardial infarction during COVID-19 pandemic: insights from the international multicenter ISACS-STEMI registry.

BACKGROUND: Chronic obstructive pulmonary disease (COPD) is projected to become the third cause of mortality worldwide. COPD shares several pathophysiological mechanisms with cardiovascular disease, especially atherosclerosis. However, no definite answers are available on the prognostic role of COPD in the setting of ST elevation myocardial infarction (STEMI), especially during COVID-19 pandemic, among patients undergoing primary angioplasty, that is therefore the aim of the current study. METHODS: In the ISACS-STEMI COVID-19 registry we included retrospectively patients with STEMI treated with primary percutaneous coronary intervention (PCI) between March and June of 2019 and 2020 from 109 high-volume primary PCI centers in 4 continents. RESULTS: A total of 15,686 patients were included in this analysis. Of them, 810 (5.2%) subjects had a COPD diagnosis. They were more often elderly and with a more pronounced cardiovascular risk profile. No preminent procedural dissimilarities were noticed except for a lower proportion of dual antiplatelet therapy at discharge among COPD patients (98.9% vs. 98.1%, P = 0.038). With regards to short-term fatal outcomes, both in-hospital and 30-days mortality occurred more frequently among COPD patients, similarly in pre-COVID-19 and COVID-19 era. However, after adjustment for main baseline differences, COPD did not result as independent predictor for in-hospital death (adjusted OR [95% CI] = 0.913[0.658-1.266], P = 0.585) nor for 30-days mortality (adjusted OR [95% CI] = 0.850 [0.620-1.164], P = 0.310). No significant differences were detected in terms of SARS-CoV-2 positivity between the two groups. CONCLUSION: This is one of the largest studies investigating characteristics and outcome of COPD patients with STEMI undergoing primary angioplasty, especially during COVID pandemic. COPD was associated with significantly higher rates of in-hospital and 30-days mortality. However, this association disappeared after adjustment for baseline characteristics. Furthermore, COPD did not significantly affect SARS-CoV-2 positivity. TRIAL REGISTRATION NUMBER: NCT04412655 (2nd June 2020).

Clinical outcomes in spontaneous coronary artery dissection.

OBJECTIVE: Spontaneous coronary artery dissection (SCAD) is an infrequent cause of acute coronary syndrome. Our aim was to assess adverse events at follow-up from a nationwide prospective cohort. METHODS: The Spanish Registry on SCAD (SR-SCAD) included patients from 34 hospitals. All coronary angiograms were analysed by two experts. Those cases with doubts regarding the diagnosis of SCAD were excluded. The angiographic SCAD classification by Saw et al was followed. Major adverse cardiovascular and cerebrovascular event (MACCE) was predefined as composite of death, myocardial infarction, unplanned revascularisation, SCAD recurrence or stroke. All events were assigned by a Clinical Events Committee. RESULTS: After corelab evaluation, 389 patients were included. Most patients were women (88%); median age 53 years (IQR 47-60). Most patients presented as non-ST-segment-elevation myocardial infarction (54%). A type 2 intramural haematoma (IMH) was the most frequent angiographic pattern (61%). A conservative initial management was selected in 78% of patients. At a median time of follow-up of 29 months (IQR 17-38), 46 patients (13%) presented MACCE, mainly driven by reinfarctions (7.6%) and unplanned revascularisations (6.2%). Previous history of hypothyroidism (HR 3.79; p<0.001), proximal vessel involvement (HR 2.69; p=0.009), type 2 IMH (HR 2.12; p=0.037) and dual antiplatelet therapy (DAPT) at discharge (HR 2.18; p=0.042) were independent predictors of MACCE. CONCLUSIONS: In this large prospective cohort of patients with SCAD, prognosis was overall favourable, with events mainly driven by reinfarctions or unplanned revascularisations. History of hypothyroidism, proximal vessel involvement, type 2 IMH and DAPT at discharge were associated with MACCE. TRIAL REGISTRATION NUMBER: NCT03607981.

Early clinical outcomes after transaxillary versus transfemoral TAVI. Data from the Spanish TAVI registry.

INTRODUCTION AND OBJECTIVES: Transaxillary access (TXA) has become the most widely used alternative to transfemoral access (TFA) in patients undergoing transcatheter aortic valve implantation (TAVI). The aim of this study was to compare total in-hospital and 30-day mortality in patients included in the Spanish TAVI registry who were treated by TXA or TFA access. METHODS: We analyzed data from patients treated with TXA or TFA and who were included in the TAVI Spanish registry. In-hospital and 30-day events were defined according to the recommendations of the Valve Academic Research Consortium. The impact of the access route was evaluated by propensity score matching according to clinical and echocardiogram characteristics. RESULTS: A total of 6603 patients were included; 191 (2.9%) were treated via TXA and 6412 via TFA access. After adjustment (n=113 TXA group and n=3035 TFA group) device success was similar between the 2 groups (94%, TXA vs 95%, TFA; P=.95). However, compared with the TFA group, the TXA group showed a higher rate of acute myocardial infarction (OR, 5.3; 95%CI, 2.0-13.8); P=.001), renal complications (OR, 2.3; 95%CI, 1.3-4.1; P=.003), and pacemaker implantation (OR, 1.6; 95%CI, 1.01-2.6; P=.03). The TXA group also had higher in-hospital and 30-day mortality rates (OR, 2.2; 95%CI, 1.04-4.6; P=.039 and OR, 2.3; 95%CI, 1.2-4.5; P=.01, respectively). CONCLUSIONS: Compared with ATF, TXA is associated with higher total mortality, both in-hospital and at 30 days. Given these results, we believe that TXA should be considered only in those patients who are not suitable candidates for TFA.

COVID-19 pandemic, mechanical reperfusion and 30-day mortality in ST elevation myocardial infarction.

OBJECTIVE: The initial data of the International Study on Acute Coronary Syndromes - ST Elevation Myocardial Infarction COVID-19 showed in Europe a remarkable reduction in primary percutaneous coronary intervention procedures and higher in-hospital mortality during the initial phase of the pandemic as compared with the prepandemic period. The aim of the current study was to provide the final results of the registry, subsequently extended outside Europe with a larger inclusion period (up to June 2020) and longer follow-up (up to 30 days). METHODS: This is a retrospective multicentre registry in 109 high-volume primary percutaneous coronary intervention (PPCI) centres from Europe, Latin America, South-East Asia and North Africa, enrolling 16 674 patients with ST segment elevation myocardial infarction (STEMI) undergoing PPPCI in March/June 2019 and 2020. The main study outcomes were the incidence of PPCI, delayed treatment (ischaemia time >12 hours and door-to-balloon >30 min), in-hospital and 30-day mortality. RESULTS: In 2020, during the pandemic, there was a significant reduction in PPCI as compared with 2019 (incidence rate ratio 0.843, 95% CI 0.825 to 0.861, p<0.0001). This reduction was significantly associated with age, being higher in older adults (>75 years) (p=0.015), and was not related to the peak of cases or deaths due to COVID-19. The heterogeneity among centres was high (p<0.001). Furthermore, the pandemic was associated with a significant increase in door-to-balloon time (40 (25-70) min vs 40 (25-64) min, p=0.01) and total ischaemia time (225 (135-410) min vs 196 (120-355) min, p<0.001), which may have contributed to the higher in-hospital (6.5% vs 5.3%, p<0.001) and 30-day (8% vs 6.5%, p=0.001) mortality observed during the pandemic. CONCLUSION: Percutaneous revascularisation for STEMI was significantly affected by the COVID-19 pandemic, with a 16% reduction in PPCI procedures, especially among older patients (about 20%), and longer delays to treatment, which may have contributed to the increased in-hospital and 30-day mortality during the pandemic. TRIAL REGISTRATION NUMBER: NCT04412655.

Transcatheter aortic valve implantation for degenerated aortic valves: Experience with a new supra-annular device. The Spanish Allegra valve-in-valve (SAVIV) registry.

OBJECTIVES: The objective was to evaluate the results of valve-in-valve procedures performed with the Allegra device. BACKGROUND: Transcatheter aortic valve implantation to treat degenerated biological aortic valves (valve-in-valve) is an established procedure in most catheterization laboratories, but the results are poorer than procedures done in native aortic stenosis. The Allegra device (Biosensors, Morges, Switzerland) has an excellent design to treat these patients. METHODS: All patients with severely degenerated biological aortic valve treated with the Allegra device in centers from Spain until December 2020 were included (n = 29). Hemodynamic results and 30-day clinical outcomes were evaluated. The predominant hemodynamic failure was stenosis in 15, regurgitation in 11, and a combination of both in 3 cases. Time from aortic valve replacement to valve-in-valve procedure was 8.4 ± 3.9 years (range 3.3-22.1). RESULTS: After the procedure, maximum and mean trans-valvular gradients were 17.4 ± 12.3 and 8.4 ± 6.1 mmHg, respectively. Device success was obtained in 28 patients (96.6%). In one patient with a degenerated 19 mm prosthetic valve, mean gradient after the procedure was 22 mmHg. No patients had a para-valvular leak grade >1. There were no deaths during the hospitalization or at 30 days and one patient suffered a stroke. CONCLUSIONS: The Allegra trans-catheter aortic valve offers optimal hemodynamic results in patients with severely degenerated biological aortic valve.

Impact of diabetes in patients waiting for invasive cardiac procedures during COVID-19 pandemic.

BACKGROUND: During COVID-19 pandemic, elective invasive cardiac procedures (ICP) have been frequently cancelled or postponed. Consequences may be more evident in patients with diabetes. OBJECTIVES: The objective was to identify the peculiarities of patients with DM among those in whom ICP were cancelled or postponed due to the COVID-19 pandemic, as well as to identify subgroups in which the influence of DM has higher impact on the clinical outcome. METHODS: We included 2,158 patients in whom an elective ICP was cancelled or postponed during COVID-19 pandemic in 37 hospitals in Spain. Among them, 700 (32.4%) were diabetics. Patients with and without diabetes were compared. RESULTS: Patients with diabetes were older and had a higher prevalence of other cardiovascular risk factors, previous cardiovascular history and co-morbidities. Diabetics had a higher mortality (3.0% vs. 1.0%; p = 0.001) and cardiovascular mortality (1.9% vs. 0.4%; p = 0.001). Differences were especially important in patients with valvular heart disease (mortality 6.9% vs 1.7% [p < 0.001] and cardiovascular mortality 4.9% vs 0.9% [p = 0.002] in patients with and without diabetes, respectively). In the multivariable analysis, diabetes remained as an independent risk factor both for overall and cardiovascular mortality. No significant interaction was found with other clinical variables. CONCLUSION: Among patients in whom an elective invasive cardiac procedure is cancelled or postponed during COVID-19 pandemic, mortality and cardiovascular mortality is higher in patients with diabetes, irrespectively on other clinical conditions. These procedures should not be cancelled in patients with diabetes.

Impact of renin-angiotensin system inhibitors on mortality during the COVID Pandemic among STEMI patients undergoing mechanical reperfusion: Insight from an international STEMI registry.

BACKGROUND: Concerns have been raised on a potential interaction between renin-angiotensin system inhibitors (RASI) and the susceptibility to coronavirus disease 2019 (COVID-19). No data have been so far reported on the prognostic impact of RASI in patients suffering from ST-elevation myocardial infarction (STEMI) during COVID-19 pandemic, which was the aim of the present study. METHODS: STEMI patients treated with primary percutaneous coronary intervention (PPCI) and enrolled in the ISACS-STEMI COVID-19 registry were included in the present sub-analysis and divided according to RASI therapy at admission. RESULTS: Our population is represented by 6095 patients, of whom 3654 admitted in 2019 and 2441 in 2020. No difference in the prevalence of SARSCoV2 infection was observed according to RASI therapy at admission (2.5% vs 2.1%, p = 0.5), which was associated with a significantly lower mortality (adjusted OR [95% CI]=0.68 [0.51-0.90], P = 0.006), confirmed in the analysis restricted to 2020 (adjusted OR [95% CI]=0.5[0.33-0.74], P = 0.001). Among the 5388 patients in whom data on in-hospital medication were available, in-hospital RASI therapy was associated with a significantly lower mortality (2.1% vs 16.7%, OR [95% CI]=0.11 [0.084-0.14], p < 0.0001), confirmed after adjustment in both periods. Among the 62 SARSCoV-2 positive patients, RASI therapy, both at admission or in-hospital, showed no prognostic effect. CONCLUSIONS: This is the first study to investigate the impact of RASI therapy on the prognosis and SARSCoV2 infection of STEMI patients undergoing PPCI during the COVID-19 pandemic. Both pre-admission and in-hospital RASI were associated with lower mortality. Among SARSCoV2-positive patients, both chronic and in-hospital RASI therapy showed no impact on survival.

Spontaneous Coronary Artery Dissection and Menopause.

Spontaneous coronary artery dissection (SCAD) is a relatively rare but well-known cause of acute coronary syndrome in women. The role of sexual hormones has been related to the pathophysiology of SCAD. However, clinical features, angiographic findings, management and outcomes of SCAD women in relation to menopause status remain unknown. The Spanish multicenter prospective SCAD registry (NCT03607981), included 318 consecutive patients with SCAD. All coronary angiograms were analyzed in a centralized Corelab. In this substudy, 245 women were classified according to their menopause state (pre-menopausal and post-menopausal). In-hospital outcomes were analyzed: 148 patients (60.4%) were post-menopausal. These patients were older (57 [52 to 66] vs 49 [44 to 54] years, p <0.01) and had more often hypertension (49% vs 27%, p <0.01) and dyslipidemia (46% vs 25%, p <0.01). Post-menopausal women showed more often previous history of acute coronary syndrome, including previous SCAD (9% vs 3%, p = 0.046), and presented less frequently as ST-segment elevation myocardial infarction on admission, compared with premenopausal women (34% vs 49%, p = 0.014). On the other hand, premenopausal women showed more often proximal and multisegment involvement (24% vs 7%, and 32% vs 18%, respectively, both p <0.01). Post-menopausal women were more often managed conservatively (85% vs 71%, p <0.01) and presented less frequently left ventricular dysfunction (both, p <0.01). There were no differences between groups in terms of in-hospital stay or mortality, new acute myocardial infarction, unplanned coronary angiography or heart failure. In conclusion, post-menopausal women with SCAD show different clinical and angiographic characteristics compared with pre-menopausal SCAD patients. Initial treatment strategy was different between groups, though in-hospital outcomes did not significantly differ (NCT03607981).

Comparison of One-Year Outcomes Between the ihtDEStiny BD Stent and the Durable-Polymer Everolimus- and Zotarolimus-Eluting Stents: A Propensity-Score-Matched Analysis.

OBJECTIVES: We sought to evaluate clinical outcomes in patients treated with the drug-eluting stent ihtDEStiny BD. BACKGROUND: The ihtDEStiny BD stent is a metallic sirolimus eluting stent with a biodegradable polymer with both drug and polymer coating the abluminal surface of the stent and balloon. METHODS: In this study, the clinical outcomes of a multicenter prospective registry of patients treated with this stent (DEStiny group) were analyzed and compared with those of a control group of patients treated with durable polymer everolimus or zotarolimus eluting stents (CONTROL group) paired by propensity score matching. Primary outcome was the target vessel failure (TVF) at 12 months defined as a composite of cardiac death, target vessel myocardial infarction (TV-MI) and target vessel revascularization (TVR). RESULTS: A total of 350 patients were included in the DESTtiny group. The control group consisted initially of 1368 patients, but after matching (1:1) 350 patients were selected as CONTROL group. The baseline clinical, angiographic and procedural characteristics were quite comparable in both groups. At 12 months follow up the TVF was 6.6% in DEStiny group and 6.3% in CONTROL group (p = 0.8). No differences were observed for any of the individual components of the primary endpoint: cardiac death 1.1% vs. 1.4%, TV-MI 3.4% vs. 3.7% and TVR 2.6% vs. 2.3% respectively. CONCLUSIONS: The use of ihtDEStiny stent in real practice is associated with a clinical performance at 12 months follow up that appears to be non-inferior to the most widely used and largely evidence supported durable polymer drug eluting stents. A longer follow up is warranted.

Mortality risk assessment in Spain and Italy, insights of the HOPE COVID-19 registry.

Recently the coronavirus disease (COVID-19) outbreak has been declared a pandemic. Despite its aggressive extension and significant morbidity and mortality, risk factors are poorly characterized outside China. We designed a registry, HOPE COVID-19 (NCT04334291), assessing data of 1021 patients discharged (dead or alive) after COVID-19, from 23 hospitals in 4 countries, between 8 February and 1 April. The primary end-point was all-cause mortality aiming to produce a mortality risk score calculator. The median age was 68 years (IQR 52-79), and 59.5% were male. Most frequent comorbidities were hypertension (46.8%) and dyslipidemia (35.8%). A relevant heart or lung disease were depicted in 20%. And renal, neurological, or oncological disease, respectively, were detected in nearly 10%. Most common symptoms were fever, cough, and dyspnea at admission. 311 patients died and 710 were discharged alive. In the death-multivariate analysis, raised as most relevant: age, hypertension, obesity, renal insufficiency, any immunosuppressive disease, 02 saturation < 92% and an elevated C reactive protein (AUC = 0.87; Hosmer-Lemeshow test, p > 0.999; bootstrap-optimist: 0.0018). We provide a simple clinical score to estimate probability of death, dividing patients in four grades (I-IV) of increasing probability. Hydroxychloroquine (79.2%) and antivirals (67.6%) were the specific drugs most commonly used. After a propensity score adjustment, the results suggested a slight improvement in mortality rates (adjusted-ORhydroxychloroquine 0.88; 95% CI 0.81-0.91, p = 0.005; adjusted-ORantiviral 0.94; 95% CI 0.87-1.01; p = 0.115). COVID-19 produces important mortality, mostly in patients with comorbidities with respiratory symptoms. Hydroxychloroquine could be associated with survival benefit, but this data need to be confirmed with further trials. Trial Registration: NCT04334291/EUPAS34399.

Renin-angiotensin system inhibitors and mortality among diabetic patients with STEMI undergoing mechanical reperfusion during the COVID-19 pandemic.

BACKGROUND: During the coronavirus disease 2019 (COVID-19) pandemic, concerns have been arisen on the use of renin-angiotensin system inhibitors (RASI) due to the potentially increased expression of Angiotensin-converting-enzyme (ACE)2 and patient's susceptibility to SARS-CoV2 infection. Diabetes mellitus have been recognized favoring the coronavirus infection with consequent increase mortality in COVID-19. No data have been so far reported in diabetic patients suffering from ST-elevation myocardial infarction (STEMI), a very high-risk population deserving of RASI treatment. METHODS: The ISACS-STEMI COVID-19 registry retrospectively assessed STEMI patients treated with primary percutaneous coronary intervention (PPCI) in March/June 2019 and 2020 in 109 European high-volume primary PCI centers. This subanalysis assessed the prognostic impact of chronic RASI therapy at admission on mortality and SARS-CoV2 infection among diabetic patients. RESULTS: Our population is represented by 3812 diabetic STEMI patients undergoing mechanical reperfusion, 2038 in 2019 and 1774 in 2020. Among 3761 patients with available data on chronic RASI therapy, between those ones with and without treatment there were several differences in baseline characteristics, (similar in both periods) but no difference in the prevalence of SARS-CoV2 infection (1.6% vs 1.3%, respectively, p = 0.786). Considering in-hospital medication, RASI therapy was overall associated with a significantly lower in-hospital mortality (3.3% vs 15.8%, p < 0.0001), consistently both in 2019 and in 2010. CONCLUSIONS: This is first study to investigate the impact of RASI therapy on prognosis and SARS-CoV2 infection of diabetic patients experiencing STEMI and undergoing PPCI during the COVID-19 pandemic. Both pre-admission chronic RASI therapy and in-hospital RASI did not negatively affected patients' survival during the hospitalization, neither increased the risk of SARS-CoV2 infection. TRIAL REGISTRATION NUMBER: NCT04412655.