Publications by authors named "Martino Pepe"

58 Publications

Direct and indirect effects of COVID-19 on acute coronary syndromes: Can we pick the worst?

Int J Cardiol 2021 Apr 24. Epub 2021 Apr 24.

Unità Operativa di Interventistica Cardiovascolare, Pineta Grande Hospital, Castel Volturno, Italy; Unità Operativa di Emodinamica, Santa Lucia Hospital, San Giuseppe Vesuviano, Italy.

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http://dx.doi.org/10.1016/j.ijcard.2021.04.036DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8064824PMC
April 2021

Anticoagulation Therapy in Patients With Coronavirus Disease 2019: Results From a Multicenter International Prospective Registry (Health Outcome Predictive Evaluation for Corona Virus Disease 2019 [HOPE-COVID19]).

Crit Care Med 2021 Apr 2. Epub 2021 Apr 2.

1 Department of Medical and Surgical Sciences, University of Foggia, Foggia, Italy. 2 Hospital Clinico San Carlos, Madrid, Spain. 3 Hospital Universitario Guadalajara, Guadalajara, Spain. 4 Hospital Universitario La Paz. Instituto de Investigacion, Hospital Universitario La Paz (IdiPAZ), Madrid, Spain. 5 Hospital Universitario Getafe, Madrid, Spain. 6 Hospital Universitario Severo Ochoa, Leganés, Spain. 7 Hospital Clinico Universitario de Valladolid, Valladolid, Spain. 8 Hospital Clinico Universitario Virgen de la Victoria, Malaga, Spain. 9 Hospital Puerta de Hierro de Majadahonda, Majadahonda, Madrid, Spain. 10 The Second Affiliated Hospital of Southern University of Science and Technology, Shenzhen, China. 11 Sant'Andrea Hospital, Vercelli, Italy. 12 San Luigi Gonzaga University Hospital, Orbassano and Rivoli Infermi Hospital, Rivoli, Italy. 13 Institute of Cardiology and Cardiovascular Surgery, Havana, Cuba. 14 Hospital General del norte de Guayaquil IESS, Los Ceibos, Guayaquil, Ecuador. 15 Hospital de la Arreixaca, Murcia, Spain. 16 University Hospital Alvaro Cunqueiro, Vigo, Spain. 17 University Hospital of Bari, Bari, Italy. 18 Nuestra Señora de América, Madrid, Spain. 19 Hospital Universitario Infanta Sofia, San Sebastian de los Reyes, Madrid, Spain. 20 San Carlo Clinic, Milano, Italy. 21 Hospital Universitario, Burgos, Spain. 22 Kerckhoff Heart and Thorax Center, Bad Nauheim, Germany. 23 Hospital General de Albacete, Albacete, Spain.

Objectives: No standard therapy, including anticoagulation regimens, is currently recommended for coronavirus disease 2019. Aim of this study was to evaluate the efficacy of anticoagulation in coronavirus disease 2019 hospitalized patients and its impact on survival.

Design: Multicenter international prospective registry (Health Outcome Predictive Evaluation for Corona Virus Disease 2019).

Setting: Hospitalized patients with coronavirus disease 2019.

Patients: Five thousand eight hundred thirty-eight consecutive coronavirus disease 2019 patients.

Interventions: Anticoagulation therapy, including prophylactic and therapeutic regimens, was obtained for each patient.

Measurements And Main Results: Five thousand four hundred eighty patients (94%) did not receive any anticoagulation before hospitalization. Two-thousand six-hundred one patients (44%) during hospitalization received anticoagulation therapy and it was not associated with better survival rate (81% vs 81%; p = 0.94) but with higher risk of bleeding (2.7% vs 1.8%; p = 0.03). Among patients admitted with respiratory failure (49%, n = 2,859, including 391 and 583 patients requiring invasive and noninvasive ventilation, respectively), anticoagulation started during hospitalization was associated with lower mortality rates (32% vs 42%; p < 0.01) and nonsignificant higher risk of bleeding (3.4% vs 2.7%; p = 0.3). Anticoagulation therapy was associated with lower mortality rates in patients treated with invasive ventilation (53% vs 64%; p = 0.05) without increased rates of bleeding (9% vs 8%; p = 0.88) but not in those with noninvasive ventilation (35% vs 38%; p = 0.40). At multivariate Cox' analysis mortality relative risk with anticoagulation was 0.58 (95% CI, 0.49-0.67) in patients admitted with respiratory failure, 0.50 (95% CI, 0.49-0.67) in those requiring invasive ventilation, 0.72 (95% CI, 0.51-1.01) in noninvasive ventilation.

Conclusions: Anticoagulation therapy in general population with coronavirus disease 2019 was not associated with better survival rates but with higher bleeding risk. Better results were observed in patients admitted with respiratory failure and requiring invasive ventilation.
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http://dx.doi.org/10.1097/CCM.0000000000005010DOI Listing
April 2021

Renin-angiotensin system inhibitors effect before and during hospitalization in COVID-19 outcomes: Final analysis of the international HOPE COVID-19 (Health Outcome Predictive Evaluation for COVID-19) registry.

Am Heart J 2021 Apr 15;237:104-115. Epub 2021 Apr 15.

Hospital Clínico San Carlos, Universidad Complutense de Madrid, Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), Madrid, Spain.

Background: The use of Renin-Angiotensin system inhibitors (RASi) in patients with coronavirus disease 2019 (COVID-19) has been questioned because both share a target receptor site.

Methods: HOPE-COVID-19 (NCT04334291) is an international investigator-initiated registry. Patients are eligible when discharged after an in-hospital stay with COVID-19, dead or alive. Here, we analyze the impact of previous and continued in-hospital treatment with RASi in all-cause mortality and the development of in-stay complications.

Results: We included 6503 patients, over 18 years, from Spain and Italy with data on their RASi status. Of those, 36.8% were receiving any RASi before admission. RASi patients were older, more frequently male, with more comorbidities and frailer. Their probability of death and ICU admission was higher. However, after adjustment, these differences disappeared. Regarding RASi in-hospital use, those who continued the treatment were younger, with balanced comorbidities but with less severe COVID19. Raw mortality and secondary events were less frequent in RASi. After adjustment, patients receiving RASi still presented significantly better outcomes, with less mortality, ICU admissions, respiratory insufficiency, need for mechanical ventilation or prone, sepsis, SIRS and renal failure (p<0.05 for all). However, we did not find differences regarding the hospital use of RASi and the development of heart failure.

Conclusion: RASi historic use, at admission, is not related to an adjusted worse prognosis in hospitalized COVID-19 patients, although it points out a high-risk population. In this setting, the in-hospital prescription of RASi is associated with improved survival and fewer short-term complications.
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http://dx.doi.org/10.1016/j.ahj.2021.04.001DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8047303PMC
April 2021

Does there exist an obesity paradox in COVID-19? Insights of the international HOPE-COVID-19-registry.

Obes Res Clin Pract 2021 Mar 3. Epub 2021 Mar 3.

University Medical Center Mannheim (UMM), University of Heidelberg, Mannheim, Germany.

Background: Obesity has been described as a protective factor in cardiovascular and other diseases being expressed as 'obesity paradox'. However, the impact of obesity on clinical outcomes including mortality in COVID-19 has been poorly systematically investigated until now. We aimed to compare clinical outcomes among COVID-19 patients divided into three groups according to the body mass index (BMI).

Methods: We retrospectively collected data up to May 31, 2020. 3635 patients were divided into three groups of BMI (<25 kg/m; n = 1110, 25-30 kg/m; n = 1464, and >30 kg/m; n = 1061). Demographic, in-hospital complications, and predictors for mortality, respiratory insufficiency, and sepsis were analyzed.

Results: The rate of respiratory insufficiency was more recorded in BMI 25-30 kg/m as compared to BMI < 25 kg/m (22.8% vs. 41.8%; p < 0.001), and in BMI > 30 kg/m than BMI < 25 kg/m, respectively (22.8% vs. 35.4%; p < 0.001). Sepsis was more observed in BMI 25-30 kg/m and BMI > 30 kg/m as compared to BMI < 25 kg/m, respectively (25.1% vs. 42.5%; p = 0.02) and (25.1% vs. 32.5%; p = 0.006). The mortality rate was higher in BMI 25-30 kg/m and BMI > 30 kg/m as compared to BMI < 25 kg/m, respectively (27.2% vs. 39.2%; p = 0.31) (27.2% vs. 33.5%; p = 0.004). In the Cox multivariate analysis for mortality, BMI < 25 kg/m and BMI > 30 kg/m did not impact the mortality rate (HR 1.15, 95% CI: 0.889-1.508; p = 0.27) (HR 1.15, 95% CI: 0.893-1.479; p = 0.27). In multivariate logistic regression analyses for respiratory insufficiency and sepsis, BMI < 25 kg/m is determined as an independent predictor for reduction of respiratory insufficiency (OR 0.73, 95% CI: 0.538-1.004; p = 0.05).

Conclusions: HOPE COVID-19-Registry revealed no evidence of obesity paradox in patients with COVID-19. However, Obesity was associated with a higher rate of respiratory insufficiency and sepsis but was not determined as an independent predictor for a high mortality.
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http://dx.doi.org/10.1016/j.orcp.2021.02.008DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7927637PMC
March 2021

Comparing the Safety and Effectiveness of Five Leading New-Generation Devices for Transcatheter Aortic Valve Implantation: Twelve-Month Results From the RISPEVA Study.

J Invasive Cardiol 2021 May 19;33(5):E320-E329. Epub 2021 Mar 19.

Department of Medico-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Corso della Repubblica 79, 04100 Latina, Italy.

Objectives: The management of severe aortic stenosis has been revolutionized by the introduction of transcatheter aortic valve implantation (TAVI), especially in patients at intermediate, high, or prohibitive surgical risk. There is uncertainty, however, regarding the comparative effectiveness and safety of contemporary TAVI devices.

Methods: We queried detailed data from the ongoing national Italian TAVI registry and compared baseline features, procedural details, and 12-month outcomes of Acurate Neo (Boston Scientific), Evolut Pro/R (Medtronic), Lotus (Boston Scientific), Portico (Abbott Vascular), and Sapien/ Sapien S3 Ultra (Edward Lifesciences) transcatheter aortic valves. Several endpoints were collected and appraised, including the composite of death, stroke, myocardial infarction (MI), major bleeding, major vascular complication, surgical aortic valve replacement and transcatheter aortic valve reimplantation, which were deemed major adverse events (MAEs).

Results: A total of 1976 patients were included, with 234 treated with Acurate, 703 with Evolut, 151 with Lotus, 347 with Portico, and 541 with Sapien. Twelve-month events were not significantly different among the 5 devices, including death (P=.29) and MAE (P=.21), with the notable exception of major vascular complications, which were more common with Acurate and Sapien (P<.001) and permanent pacemaker implantation, which was more frequent with Lotus and Evolut (P<.001). Differences in MAE were more pronounced in women and subjects with prior cardiac surgery, with the lowest event rates in the Evolut group. Propensity-score adjusted analysis suggested that Acurate, Evolut, Portico, and Sapien were all associated with similarly favorable results, whereas adverse events were more evident with Lotus (P<.05).

Conclusion: Leading current-generation TAVI devices offer similarly favorable results at mid-term follow-up.
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May 2021

Thrombocytopenia Complicating Transcatheter Aortic Valve Implantation: Differences Between Two New-Generation Devices.

J Cardiovasc Transl Res 2021 Mar 15. Epub 2021 Mar 15.

Unità Operativa di Interventistica Cardiovascolare, Pineta Grande Hospital, Castel Volturno, Italy.

Thrombocytopenia after TAVI is common and clinically detrimental. Retrospectively, we observed Portico recipients had a more profound platelet drop than Evolut recipients. We thus investigated periprocedural platelet damage and/orpro-inflammatory state in 64 TAVI recipients at baseline and after implantation. Platelet damage was assessed by annexin V staining and monocyte-phagocytic phenotype was assessed according to CD14/CD36 expression. Serum cytokines were measured in 20 patients. The formaldehyde-based storage solution altered platelets. When, before being loaded onto the delivery system, Portico underwent one additional flushing to those recommended, the receiving patients showed thrombocytopenia, platelet damage, and CD36-monocyte count were mitigated. A general increase in IL-6 was recorded in overall TAVI recipients, but a high serum level of IL-8, a potent thrombocytopenia inducer, was measured in Portico recipients only, including those with extra-rinsed valve. Our study suggests a platelet-injury effect by storage-solution and generates the hypothesis of a role for the biomaterial in stimulating innate-immunity. Larger prospective studies are needed. Graphical Abstract.
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http://dx.doi.org/10.1007/s12265-021-10117-9DOI Listing
March 2021

Safety of reduced or absent antithrombotic therapy after left atrial appendage closure in patients affected by hereditary haemorrhagic telangiectasia and atrial fibrillation.

Minerva Cardiol Angiol 2021 Mar 11. Epub 2021 Mar 11.

C. Frugoni Internal Medicine Unit, Department of Interdisciplinary Medicine, Center for Rare Diseases, VascERN HHT Reference Center Policlinico University Hospital, University of Bari, Bari, Italy.

Background: Left atrial appendage (LAA) closure represents a novel therapeutic chance for patients with contraindications to long-term anticoagulation therapy, such as those affected by Hereditary Hemorrhagic Telangiectasia (HHT) and atrial fibrillation (AF). Nevertheless, current experts' indications suggest the post-procedural administration of antithrombotic therapies to minimize the residual thromboembolic risk due to AF and to the need for device endothelialization. The aim of our study was to investigate the safety and effectiveness of LAA closure in preventing arterial thromboembolism in a very high-bleeding risk group, such as HHT patients, who are at risk not to tolerate even the mild post-procedural antithrombotic therapy usually recommended.

Methods: Eight HHT-affected patients with non-valvular AF, high-bleeding risk and/or known intolerance to antiplatelet and anticoagulant therapy were treated with interventional LAA occlusion with the Amplatzer™ Cardiac Plug™ and Amplatzer™ Amulet™ devices. Device implantation was successful in all patients.

Results: Post-procedural antiplatelet/anticoagulation therapy was attempted in seven patients: adherence to therapy exceeded six months only for one, while four patients suspended all antithrombotic medications within 30 days from the procedure due to an increase in bleeding frequency and/or severity and the other two discontinued treatment within six months; a single patient was not prescribed any antithrombotic therapy. At a medium follow-up of 22.4±14.3 months no thromboembolic episodes attributable to AF or device related thrombosis were reported. Two deaths were recorded 1231 and 783 days after the procedure which were classified as unrelated to any cerebral or cardiovascular accident.

Conclusions: Our study suggests that the percutaneous LAA closure in HHT patients with AF could be safe and effective in preventing arterial systemic thromboembolism, also in the presence of reduced or absent post-interventional antithrombotic treatment. LAA occluder implantation can represent a valid and potentially life-saving alternative to lifelong anticoagulant therapy in HHT, as in other very high-bleeding risk patients.
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http://dx.doi.org/10.23736/S2724-5683.20.05474-2DOI Listing
March 2021

COVID-19 anosmia and gustatory symptoms as a prognosis factor: a subanalysis of the HOPE COVID-19 (Health Outcome Predictive Evaluation for COVID-19) registry.

Infection 2021 Mar 1. Epub 2021 Mar 1.

Hospital Clínico San Carlos, Madrid, Spain.

Olfactory and gustatory dysfunctions (OGD) are a frequent symptom of coronavirus disease 2019 (COVID-19). It has been proposed that the neuroinvasive potential of the novel SARS-CoV-2 could be due to olfactory bulb invasion, conversely studies suggest it could be a good prognostic factor. The aim of the current study was to investigate the prognosis value of OGD in COVID-19. These symptoms were recorded on admission from a cohort study of 5868 patients with confirmed or highly suspected COVID-19 infection included in the multicenter international HOPE Registry (NCT04334291). There was statistical relation in multivariate analysis for OGD in gender, more frequent in female 12.41% vs 8.67% in male, related to age, more frequent under 65 years, presence of hypertension, dyslipidemia, diabetes, smoke, renal insufficiency, lung, heart, cancer and neurological disease. We did not find statistical differences in pregnant (p = 0.505), patient suffering cognitive (p = 0.484), liver (p = 0.1) or immune disease (p = 0.32). There was inverse relation (protective) between OGD and prone positioning (0.005) and death (< 0.0001), but no with ICU (0.165) or mechanical ventilation (0.292). On univariable logistic regression, OGD was found to be inversely related to death in COVID-19 patients. The odds ratio was 0.26 (0.15-0.44) (p < 0.001) and Z was - 5.05. The presence of anosmia is fundamental in the diagnosis of SARS.CoV-2 infection, but also could be important in classifying patients and in therapeutic decisions. Even more knowing that it is an early symptom of the disease. Knowing that other situations as being Afro-American or Latino-American, hypertension, renal insufficiency, or increase of C-reactive protein (CRP) imply a worse prognosis we can make a clinical score to estimate the vital prognosis of the patient. The exact pathogenesis of SARS-CoV-2 that causes olfactory and gustative disorders remains unknown but seems related to the prognosis. This point is fundamental, insomuch as could be a plausible way to find a treatment.
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http://dx.doi.org/10.1007/s15010-021-01587-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7917537PMC
March 2021

Baseline, procedural and outcome features of patients undergoing transcatheter aortic valve implantation according to different body mass index categories.

Minerva Med 2021 Feb 12. Epub 2021 Feb 12.

Unità Operativa di Interventistica Cardiovascolare, Pineta Grande Hospital, Castel Volturno, Caserta, Italy.

Background: Transcatheter aortic valve implantation (TAVI) has become first-line treatment for severe aortic valve stenosis in patients with moderate, high or prohibitive surgical risk.. However, access site complications may occur more frequently in such extreme body mass index (BMI) categories,. We aimed at describing features and outcomes of patients undergoing TAVI in a comprehensive Italian prospective clinical registry.

Methods: A national prospective database was queried for baseline, procedural, and outcome details of patients undergoing TAVI according to established BMI classes: underweight (BMI <18.5 kg/m2), normal weight (BMI 18.5-24.9 kg/m2), overweight (BMI 25.0-29.9 kg/m2), and obese (BMI ≥30 kg/m2). Short- and long-term outcomes, including major adverse events (MAE), i.e. the composite of death, stroke, myocardial infarction, major vascular complication, major bleeding, or renal failure, were appraised with bivariate and multivariable analyses.

Results: A total of 3075 subjects were included, 64 (2.1%) were underweight, 1319 (42.9%) were normal weight, 1152 (37.4%) were overweight, and 540 (17.6%) were obese. Several baseline differences were evident, including gender, diabetes mellitus, renal function, chronic obstructive pulmonary disease, surgical scores, and left ventricular ejection fraction (LVEF) (all p<0.05). Several procedural differences were also evident, including percutaneous approach, predilation, prosthesis type and size (all p<0.05), with postprocedura aortic regurgitation >2+ significantly more common in underweight patients (p<0.05). Nonetheless, unadjusted analysis for one-month outcomes showed similar rates for fatal and non-fatal outcomes, including MAE (all p>0.05), with the notable exception of permanent pacemaker implantation, which was more common in higher BMI classes (p=0.010) Unadjusted analysis for long-term events showed an increased rate of death in underweight patients (p=0.024). Multivariable adjusted analysis confirmed the increased risk of permanent pacemaker implantation in obese patients (p=0.015 when comparing obese vs normal weight subjects), but disproved differences in mortality (p>0.05 for all comparisons).

Conclusions: Irrespective of BMI class, TAVI is associated with favorable outcomes in surgical high-risk risk patients, with the notable exclusion of permanent pacemaker implantation, which is significantly more common in obese subjects.
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http://dx.doi.org/10.23736/S0026-4806.21.07379-1DOI Listing
February 2021

Clinical presentation, therapeutic approach, and outcome of young patients admitted for COVID-19, with respect to the elderly counterpart.

Clin Exp Med 2021 May 8;21(2):249-268. Epub 2021 Feb 8.

Hospital Clinico San Carlos, Madrid, Spain.

There is limited information on the presenting characteristics, prognosis, and therapeutic approaches of young patients hospitalized for coronavirus disease 2019 (COVID-19). We sought to investigate the baseline characteristics, in-hospital treatment, and outcomes of a wide cohort < 65 years admitted for COVID-19. Using the international multicenter HOPE-COVID-19 registry, we evaluated the baseline characteristics, clinical presentation, therapeutic approach, and prognosis of patients < 65 years discharged (deceased or alive) after hospital admission for COVID-19, also compared with the elderly counterpart. Of the included 5746 patients, 2676 were < 65 and 3070 ≥ 65 years. All risk factors and several parameters suggestive of worse clinical presentation augmented through increasing age classes. In-hospital mortality rates were 6.8% and 32.1% in the younger and older cohort, respectively (p < 0.001). Among young patients, mortality, access to ICU and treatment with IMVwere positively correlated with age. Contrariwise, over 65 years of age this trend was broken so that only the association between age and mortality was persistent, while the rates of access to ICU and IMV started to decline. Younger patients also recognized specific predictors of case fatality, such as obesity and gender. Age negatively impacts on mortality, access to ICU and treatment with IMV in patients < 65 years. In elderly patients only case fatality rate keeps augmenting in a stepwise manner through increasing age categories, while therapeutic approaches become more conservative. Besides age, obesity, gender, history of cancer, and severe dyspnea, tachypnea, chest X-ray bilateral abnormalities, abnormal level of creatinine and leucocyte among admission parameters seem to play a central role in the outcome of patients younger than 65 years.
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http://dx.doi.org/10.1007/s10238-021-00684-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7868661PMC
May 2021

Prevalence and 30-Day Mortality in Hospitalized Patients With Covid-19 and Prior Lung Diseases.

Arch Bronconeumol 2021 04 16;57 Suppl 2:13-20. Epub 2020 Dec 16.

Hospital Clínico San Carlos, Universidad Complutense de Madrid, Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), Madrid, Spain.

Introduction: Patients with pre-existing respiratory diseases in the setting of COVID-19 may have a greater risk of severe complications and even death.

Methods: A retrospective, multicenter, cohort study with 5847 COVID-19 patients admitted to hospitals. Patients were separated in two groups, with/without previous lung disease. Evaluation of factors associated with survival and secondary composite end-point such as ICU admission and respiratory support, were explored.

Results: 1,271 patients (22%) had a previous lung disease, mostly COPD. All-cause mortality occurred in 376 patients with lung disease (29.5%) and in 819 patients without (17.9%) (p<0.001). Kaplan-Meier curves showed that patients with lung diseases had a worse 30-day survival (HR=1.78; 95%C.I. 1.58-2.01; p<0.001) and COPD had almost 40% mortality. Multivariable Cox regression showed that prior lung disease remained a risk factor for mortality (HR, 1.21; 95%C.I. 1.02-1.44; p=0.02). Variables independently associated with all-cause mortality risk in patients with lung diseases were oxygen saturation less than 92% on admission (HR, 4.35; 95% CI 3.08-6.15) and elevated D-dimer (HR, 1.84; 95% CI 1.27-2.67). Age younger than 60 years (HR 0.37; 95% CI 0.21-0.65) was associated with decreased risk of death.

Conclusions: Previous lung disease is a risk factor for mortality in patients with COVID-19. Older age, male gender, home oxygen therapy, and respiratory failure on admission were associated with an increased mortality. Efforts must be done to identify respiratory patients to set measures to improve their clinical outcomes.
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http://dx.doi.org/10.1016/j.arbres.2020.11.012DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7744014PMC
April 2021

Assessing the Best Prognostic Score for Transcatheter Aortic Valve Implantation (from the RISPEVA Registry).

Am J Cardiol 2021 04 29;144:91-99. Epub 2020 Dec 29.

Invasive Cardiology Unit, "Pineta Grande" Hospital, Caserta, Italy.

The ACC/TVT score is a specific predictive model of in-hospital mortality for patients undergoing transcatheter aortic valve implantation (TAVI). The aim of this study was to test its predictive accuracy in comparison with standard surgical risk models (Logistic Euroscore, Euroscore II, and STS-PROM) in the population of TAVI patients included in the multicenter RISPEVA (Registro Italiano GISE sull'impianto di Valvola Aortica Percutanea) registry. The study cohort included 3293 patients who underwent TAVI between 2008 and 2019. The 4 risk scores were calculated for all patients. For all scores, the capability to predict 30-day mortality was assessed by means of several analyses testing calibration and discrimination. The ACC/TVT score showed moderate discrimination, with a C-statistics for 30-day mortality of 0.63, not significantly different from the standard surgical risk models. The ACC/TVT score demonstrated, in contrast, better calibration compared with the other scores, as proved by a greater correspondence between estimated probabilities and the actual observations. However, when the ACC/TVT score was tested in the subgroup of patients treated in a more contemporary period (from 2016 on), it revealed a slight tendency to lose discrimination and to overestimate mortality risk. In conclusion, in comparison with the standard surgical risk models, the ACC/TVT score demonstrated better prediction accuracy for estimation of 30-day mortality in terms of calibration. Nevertheless, its predictive reliability remained suboptimal and tended to worsen in patients treated more recently.
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http://dx.doi.org/10.1016/j.amjcard.2020.12.068DOI Listing
April 2021

Underlying heart diseases and acute COVID-19 outcomes.

Cardiol J 2021 21;28(2):202-214. Epub 2020 Dec 21.

Hospital Clinico San Carlos, Prof Martin Lagos, sn, 28040 Madrid, Spain.

Background: The presence of any underlying heart condition could influence outcomes during the coronavirus disease 2019 (COVID-19).

Methods: The registry HOPE-COVID-19 (Health Outcome Predictive Evaluation for COVID-19, NCT04334291) is an international ambispective study, enrolling COVID-19 patients discharged from hospital, dead or alive.

Results: HOPE enrolled 2798 patients from 35 centers in 7 countries. Median age was 67 years (IQR: 53.0-78.0), and most were male (59.5%). A relevant heart disease was present in 682 (24%) cases. These were older, more frequently male, with higher overall burden of cardiovascular risk factors (hypertension, dyslipidemia, diabetes mellitus, smoking habit, obesity) and other comorbidities such renal failure, lung, cerebrovascular disease and oncologic antecedents (p < 0.01, for all). The heart cohort received more corticoids (28.9% vs. 20.4%, p < 0.001), antibiotics, but less hydroxychloroquine, antivirals or tocilizumab. Considering the epidemiologic profile, a previous heart condition was independently related with shortterm mortality in the Cox multivariate analysis (1.62; 95% CI 1.29-2.03; p < 0.001). Moreover, heart patients needed more respiratory, circulatory support, and presented more in-hospital events, such heart failure, renal failure, respiratory insufficiency, sepsis, systemic infammatory response syndrome and clinically relevant bleedings (all, p < 0.001), and mortality (39.7% vs. 15.5%; p < 0.001).

Conclusions: An underlying heart disease is an adverse prognostic factor for patients suffering COVID-19. Its presence could be related with different clinical drug management and would benefit from maintaining treatment with angiotensin converting enzyme inhibitors or angiotensin receptor blockers during in-hospital stay.
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http://dx.doi.org/10.5603/CJ.a2020.0183DOI Listing
May 2021

Prognostic Impact of Hyponatremia and Hypernatremia in COVID-19 Pneumonia. A HOPE-COVID-19 (Health Outcome Predictive Evaluation for COVID-19) Registry Analysis.

Front Endocrinol (Lausanne) 2020 30;11:599255. Epub 2020 Nov 30.

Hospital Clínico San Carlos, Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), Madrid, Spain.

Dysnatremia is associated with increased mortality in patients with community-acquired pneumonia. SARS-COV2 (Severe-acute-respiratory syndrome caused by Coronavirus-type 2) pneumonia can be fatal. The aim of this study was to ascertain whether admittance dysnatremia is associated with mortality, sepsis, or intensive therapy (IT) in patients hospitalized with SARS-COV2 pneumonia. This is a retrospective study of the HOPE-COVID-19 registry, with data collected from January 1 through April 31, 2020. We selected all hospitalized adult patients with RT-PCR-confirmed SARS-COV2 pneumonia and a registered admission serum sodium level (SNa). Patients were classified as hyponatremic (SNa <135 mmol/L), eunatremic (SNa 135-145 mmol/L), or hypernatremic (SNa >145 mmol/L). Multivariable analyses were performed to elucidate independent relationships of admission hyponatremia and hypernatremia, with mortality, sepsis, or IT during hospitalization. Four thousand six hundred sixty-four patients were analyzed, median age 66 (52-77), 58% males. Death occurred in 988 (21.2%) patients, sepsis was diagnosed in 551 (12%) and IT in 838 (18.4%). Hyponatremia was present in 957/4,664 (20.5%) patients, and hypernatremia in 174/4,664 (3.7%). Both hyponatremia and hypernatremia were associated with mortality and sepsis. Only hyponatremia was associated with IT. In conclusion, hyponatremia and hypernatremia at admission are factors independently associated with mortality and sepsis in patients hospitalized with SARS-COV2 pneumonia.

Clinical Trial Registration: https://clinicaltrials.gov/ct2/show/NCT04334291, NCT04334291.
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http://dx.doi.org/10.3389/fendo.2020.599255DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7734292PMC
January 2021

Minimally invasive approaches to primary cardiac tumors: A systematic review and meta-analysis.

J Card Surg 2021 Feb 1;36(2):483-492. Epub 2020 Dec 1.

Department of Cardio-Thoracic Surgery, Weill Cornell Medicine, New York, New York, USA.

Objective: Cardiac tumors are rare conditions. The vast majority of them are benign yet they may lead to serious complications. Complete surgical resection is the gold standard treatment and should be performed as soon as the diagnosis is made. Median sternotomy (MS) is the standard approach and provides excellent early outcomes and durable results at follow-up. However, minimally invasive (MI) is gaining popularity and its role in the treatment of cardiac tumors needs further clarification.

Methods: A systematic literature review identified 12 candidate studies; of these, 11 met the meta-analysis criteria. We analyzed outcomes of 653 subjects (294 MI and 359 MS) with random effects modeling. Each study was assessed for heterogeneity. The primary endpoints were mortality at follow-up and tumor relapse. Secondary endpoints included relevant intraoperative and postoperative outcomes; tumor size was also considered.

Results: There were no significant between-group differences in terms of late mortality (incidence rate ratio [IRR]: MI vs. MS, 0.98 [95% confidence interval [CI]: 0.25-3.82], p = .98). Few relapses (IRR: 1.13; CI: 0.26-4.88; p = .87) and redo surgery (IRR: 1.92; 95% CI: 0.39-9.53; p = .42) were observed in both groups; MI approach resulted in prolonged operation time but that did not influence the clinical outcomes. Tumor size did not significantly differ between groups.

Conclusion: Both MI and MS are associated with excellent early and late outcomes with acceptable survival rate and low incidence of recurrences. This study confirms that cardiac tumor may be approached safely and radically with a MI approach.
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http://dx.doi.org/10.1111/jocs.15224DOI Listing
February 2021

Clinical profile and predictors of in-hospital mortality among older patients hospitalised for COVID-19.

Age Ageing 2021 02;50(2):326-334

Unidad de Gestión Clínica Área del Corazón, Instituto de Investigación Biomédica de Málaga (IBIMA), Hospital Universitario Virgen de la Victoria, Universidad de Málaga (UMA), Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares (CIBERCV), Málaga, Spain.

Background: the coronavirus disease 2019 (COVID-19) is characterized by poor outcomes and mortality, particularly in older patients.

Methods: post hoc analysis of the international, multicentre, 'real-world' HOPE COVID-19 registry. All patients aged ≥65 years hospitalised for COVID-19 were selected. Epidemiological, clinical, analytical and outcome data were obtained. A comparative study between two age subgroups, 65-74 and ≥75 years, was performed. The primary endpoint was all cause in-hospital mortality.

Results: about, 1,520 patients aged ≥65 years (60.3% male, median age of 76 [IQR 71-83] years) were included. Comorbidities such as hypertension (69.2%), dyslipidaemia (48.6%), cardiovascular diseases (any chronic heart disease in 38.4% and cerebrovascular disease in 12.5%), and chronic lung disease (25.3%) were prevalent, and 49.6% were on ACEI/ARBs. Patients aged 75 years and older suffered more in-hospital complications (respiratory failure, heart failure, renal failure, sepsis) and a significantly higher mortality (18.4 vs. 48.2%, P < 0.001), but fewer admissions to intensive care units (11.2 vs. 4.8%). In the overall cohort, multivariable analysis demonstrated age ≥75 (OR 3.54), chronic kidney disease (OR 3.36), dementia (OR 8.06), peripheral oxygen saturation at admission <92% (OR 5.85), severe lymphopenia (<500/mm3) (OR 3.36) and qSOFA (Quick Sequential Organ Failure Assessment Score) >1 (OR 8.31) to be independent predictors of mortality.

Conclusion: patients aged ≥65 years hospitalised for COVID-19 had high rates of in-hospital complications and mortality, especially among patients 75 years or older. Age ≥75 years, dementia, peripheral oxygen saturation <92%, severe lymphopenia and qSOFA scale >1 were independent predictors of mortality in this population.
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http://dx.doi.org/10.1093/ageing/afaa258DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7717146PMC
February 2021

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

Intern Emerg Med 2020 Nov 9. Epub 2020 Nov 9.

Hospital Clínico Universitario de Valladolid, Valladolid, Spain.

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-OR 0.88; 95% CI 0.81-0.91, p = 0.005; adjusted-OR 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.
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http://dx.doi.org/10.1007/s11739-020-02543-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7649104PMC
November 2020

Remote ischemic preconditioning in isolated valve intervention. A pooled meta-analysis.

Int J Cardiol 2021 Feb 15;324:146-151. Epub 2020 Oct 15.

Imperial College London, National Heart Lung Institute, UK.

Objective: Recent studies have shown no benefits from remote ischemic preconditioning (RIPC) in patients undergoing coronary artery bypass surgery. One possible explanation is that given previous exposure to angina and ischemia/reperfusion injury these patients, may be already 'naturally preconditioned'. The role of RIPC in a context of isolated valve intervention, both surgical and particularly transcatheter is less clear and remains under investigated, with few high-quality studies.

Methods: A systematic literature review identified 8 candidate studies that met the meta-analysis criteria. We analyzed outcomes of 610 subjects (312 RIPC and 298 SHAM) with random effects modeling. Each study was assessed for heterogeneity. The primary outcome was the extent of periprocedural myocardial injury, as reflected by the area under the curve for serum troponin concentration. Secondary endpoints included relevant intra- and post-operative outcomes; sensitivity and high-quality subgroup analysis was also carried out.

Results: Six and two studies reported the effect of RIPC in surgical and transcatheter valve intervention. There was a significant difference between-group in terms of periprocedural Troponin release (standardized mean difference (SMD: 0.74 [95% CI: 0.52; 0.95], p = 0.02) with no heterogeneity (χ 2.40, I 0%, p = 0.88). RIPC was not associated with any improvement in post-operative outcomes. No serious adverse RIPC related events were reported.

Conclusions: RIPC seems to elicit overall periprocedural cardioprotection in patients undergoing valvular intervention, yet with no benefit on early clinical outcomes.
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http://dx.doi.org/10.1016/j.ijcard.2020.10.020DOI Listing
February 2021

Late gadolinium enhancement role in arrhythmic risk stratification of patients with LMNA cardiomyopathy: results from a long-term follow-up multicentre study.

Europace 2020 12;22(12):1864-1872

Department of Arrhythmology and Cardiac Electrophysiology, IRCCS San Raffaele Hospital, Milan, Italy.

Aims: We aimed at addressing the role of late gadolinium enhancement (LGE) in arrhythmic risk stratification of LMNA-associated cardiomyopathy (CMP).

Methods And Results: We present data from a multicentre national cohort of patients with LMNA mutations. Of 164 screened cases, we finally enrolled patients with baseline cardiac magnetic resonance (CMR) including LGE sequences [n = 41, age 35 ± 17 years, 51% males, mean left ventricular ejection fraction (LVEF) by echocardiogram 56%]. The primary endpoint of the study was follow-up (FU) occurrence of malignant ventricular arrhythmias [MVA, including sustained ventricular tachycardia (VT), ventricular fibrillation, and appropriate implantable cardioverter-defibrillator (ICD) therapy]. At baseline CMR, 25 subjects (61%) had LGE, with non-ischaemic pattern in all of the cases. Overall, 23 patients (56%) underwent ICD implant. By 10 ± 3 years FU, eight patients (20%) experienced MVA, consisting of appropriate ICD shocks in all of the cases. In particular, the occurrence of MVA in LGE+ vs. LGE- groups was 8/25 vs. 0/16 (P = 0.014). Of note, no significant differences between LGE+ and LGE- patients were found in currently recognized risk factors for sudden cardiac death (male gender, non-missense mutations, baseline LVEF <45% and non-sustained VT), all P-value >0.05.

Conclusions: In LMNA-CMP patients, LGE at baseline CMR is significantly associated with MVA. In particular, as suggested by this preliminary experience, the absence of LGE allowed to rule-out MVA at 10 years mean FU.
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http://dx.doi.org/10.1093/europace/euaa171DOI Listing
December 2020

The best way to transcatheter aortic valve implantation: From standard to new approaches.

Int J Cardiol 2021 Jan 16;322:86-94. Epub 2020 Aug 16.

Unità Operativa di Interventistica Cardiovascolare, Pineta Grande Hospital, Castel Volturno, Italy.

Transcatheter aortic valve implantation (TAVI) is a safe and beneficial treatment for patients with severe symptomatic aortic stenosis at high and intermediate surgical risk. The safety of the procedure continues to improve thanks to more refined procedural approaches and devices but, also and above all, to the accrual of the procedural knowledge and expertise by the operators. The diversification of the approaches and the possibility to tailor the treatment on the individual needs and anatomical features of the patients allows a rapid learning curve in the management of even complications. Indeed, there are several approaches with which TAVI can be carried out: transfemoral arterial, subclavian, transcarotid, transaortic, transaxillary, transapical, and through right anterior thoracotomy. Although transfemoral venous TAVI is less common, it has already have been carried out using caval-aortic punctures. This field is rapidly evolving, and it will be of paramount importance for interventional cardiologists and cardiothoracic surgeons to keep up to date with further developments. This review intends to give an in-depth and update overview of both conventional and innovative TAVI approaches, with the scope to highlight the relevant advantages, major disadvantages, safety aspects and techniques.
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http://dx.doi.org/10.1016/j.ijcard.2020.08.036DOI Listing
January 2021

Impact of renal function on admission in COVID-19 patients: an analysis of the international HOPE COVID-19 (Health Outcome Predictive Evaluation for COVID 19) Registry.

J Nephrol 2020 08 29;33(4):737-745. Epub 2020 Jun 29.

Hospital Clínico San Carlos, Universidad Complutense de Madrid, Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), Madrid, Spain.

Background: Coronavirus disease 2019 (COVID-19) is a disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Despite its international aggressive extension, with a significant morbidity and mortality, the impact of renal function on its prognosis is uncertain.

Methods: Analysis from the international HOPE-Registry (NCT04334291). The objective was to evaluate the association between kidney failure severity on admission with the mortality of patients with SARS-CoV-2 infection. Patients were categorized in 3 groups according to the estimated glomerular filtration rate on admission (eGFR > 60 mL/min/1.73 m, eGFR 30-60 mL/min/1.73 m and eGFR < 30 mL/min/1.73 m).

Results: 758 patients were included: mean age was 66 ± 18 years, and 58.6% of patient were male. Only 8.5% of patients had a history of chronic kidney disease (CKD); however, 30% of patients had kidney dysfunction upon admission (eGFR < 60 mL/min/1.73 m). These patients received less frequently pharmacological treatment with hydroxychloroquine or antivirals and had a greater number of complications such as sepsis (11.9% vs 26.4% vs 40.8%, p < 0.001) and respiratory failure (35.4% vs 72.2% vs 62.0%, p < 0.001) as well as a higher in-hospital mortality rate (eGFR > 60 vs eGFR 30-60 vs and eGFR < 30, 18.4% vs 56.5% vs 65.5%, p < 0.001). In multivariate analysis: age, hypertension, renal function, 0 saturation < 92% and lactate dehydrogenase elevation on admission independently predicted all-cause mortality.

Conclusions: Renal failure on admission in patients with SARS-CoV-2 infection is frequent and is associated with a greater number of complications and in-hospital mortality. Our data comes from a multicenter registry and therefore does not allow to have a precise mortality risk assessment. More studies are needed to confirm these findings.
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http://dx.doi.org/10.1007/s40620-020-00790-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7322375PMC
August 2020

Inflammatory Bowel Disease and Acute Coronary Syndromes: From Pathogenesis to the Fine Line Between Bleeding and Ischemic Risk.

Inflamm Bowel Dis 2021 Apr;27(5):725-731

Cardiovascular Diseases Section, Cardiothoracic Department, University of Bari, Bari, Italy.

Inflammatory bowel disease (IBD) is a pathological condition that first involves the gastrointestinal wall but can also trigger a systemic inflammatory state and thus extraintestinal manifestations. Systemic inflammation is probably secondary to the passage of bacterial products into the bloodstream because of altered intestinal permeability and the consequent release of proinflammatory mediators. Inflammation, through several diverse pathophysiological pathways, determines both a procoagulative state and systemic endothelial dysfunction, which are both deemed to be responsible for venous and arterial thromboembolic adverse events. The management of systemic thrombotic complications is particularly challenging in this category of patients, who also present a high bleeding risk; what is more, both bleeding and thrombotic risks peak during the active phases of the disease. The literature suggests that treating physicians have been, so far, more heavily influenced by concerns about bleeding than by the thrombotic risk. Despite the absence of data provided by large cohorts or randomized studies, the high risk of arterial and venous atherothrombosis in patients with IBD seems unquestionable. Moreover, several reports suggest that when arterial thromboembolism involves the coronary vessels, causing acute coronary syndromes, ischemic complications from antithrombotic drug undertreatment are frequent and severe. This review aims to shed light on the tricky balance between the ischemic and hemorrhagic risks of patients with IBD and to highlight how difficult it is for clinicians to define a tailored therapy based on a case-by-case, careful, and unprejudiced clinical evaluation.
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http://dx.doi.org/10.1093/ibd/izaa160DOI Listing
April 2021

Comparison of Outcomes of Transcatheter Aortic Valve Implantation in Patients ≥85 Years Versus Those <85 Years.

Am J Cardiol 2020 08 26;129:60-70. Epub 2020 May 26.

Invasive Cardiology Unit, "Pineta Grande" Hospital, Castel Volturno, Caserta, Italy.

The differential outcomes across the age spectrum of transcatheter aortic valve implantation (TAVI) recipients are still debated. Aim of the study was to evaluate the clinical outcomes of oldest-old patients undergoing TAVI in the large "Registro Italiano GISE sull'impianto di Valvola Aortica Percutanea (RISPEVA)" registry. A total of 3,507 patients were stratified according to age: 1,381 were ≥85 years, 2,126 were <85 years. Primary endpoints were death at 30-days and complete follow-up (FU) (medium 368 days). Cerebrovascular events, myocardial infarction, bleedings, vascular complications at 30-days and complete FU were considered. In the unadjusted analysis, 30-days mortality in the oldest-old group was higher than in younger patients (4.2% vs 2.4%; p = 0.007); this difference kept true also at complete FU (19.6% vs 15.9%; p = 0.014). After propensity score (PS) matching, the oldest-old population showed a higher mortality solely at 30-days (4.7% vs 2.4%; p = 0.016), while the survival at complete FU was similar to that of younger patients (20.1% vs 18.0%; p = 0.286). The incidence of non-fatal outcomes resulted comparable between the 2 groups, also after propensity score matching. At the multivariate logistic regression analysis procedural major or disabling bleedings, cerebrovascular events, cardiogenic shock resulted predictors of 30-days death in the oldest-old cohort. In conclusion, patients ≥85 years can safely undergo TAVI being not more exposed to procedural complications than those <85 years; nevertheless they showed worse 30-days mortality, probably driven by reduced tolerance to complications. Passed the critical periprocedural phase, patients ≥85 years had a similar survival to those <85 years with comparable risk profile.
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http://dx.doi.org/10.1016/j.amjcard.2020.05.033DOI Listing
August 2020

Degenerative Severe Aortic Stenosis and Concomitant Coronary Artery Disease: What Is Changing in the Era of the "Transcatheter Revolution"?

Curr Atheroscler Rep 2020 05 26;22(5):17. Epub 2020 May 26.

Division of Cardiology, Department of Emergency and Organ Transplantation, University of Bari, Bari, Italy.

Purpose Of Review: To summarize epidemiology, pathophysiology, prognostic relevance, and treatment options of coronary artery disease (CAD) when coupled with severe aortic stenosis (SAS). In regard to treatment options, we focused on the most recently adopted therapeutic approaches and on the future perspectives in light of the latest percutaneous and surgical technical improvements in the field of both CAD and SAS management.

Recent Findings: Nowadays, SAS is the most common valve disease requiring intervention, either surgical or percutaneous. On the other side, CAD is one of the leading causes of death in the developed countries. CAD and degenerative SAS share several predisposing factors and are often concurrently found in clinical practice. Despite in the last years the transcatheter aortic valve replacement (TAVR) has been deeply changing the therapeutic approach to SAS, the correct management of patients with concomitant CAD remains controversial due to limited and heterogeneous data in the literature. Coronary revascularization is often performed in patients with concomitant CAD and SAS. Complete surgical approach is still the standard of care according to international guidelines. However, in light of the recent results of TAVR trials, the therapeutic approach is expected to change. To date, percutaneous coronary intervention performed before TAVR is safe and feasible even if the optimal timing for revascularization remains debated. Due to the great complexity of the patients affected by SAS and CAD and until unquestionable truths will come from large randomized trials, the role of the Heart Team in the decision-making process is of primary importance to guarantee the best tailored therapeutic strategy for the single patient.
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http://dx.doi.org/10.1007/s11883-020-0835-1DOI Listing
May 2020

Percutaneous exclusion of ascending aorta pseudoaneurysms: still an interventional challenge?

J Cardiol Cases 2020 Apr 5;21(4):130-133. Epub 2019 Dec 5.

Interventional Cardiology Service, "Mater Dei" Hospital, Bari, Italy.

Ascending aortic pseudoaneurysm is a rare pathology that could have multiple etiologies such as thoracic trauma, infection, and percutaneous or surgical procedures. In patients with aortic pseudoaneurysms, open surgical or endovascular interventions are always indicated, if feasible and independent of size. Several types of endovascular treatment have been reported in the literature, but they have been mostly restricted to those cases when traditional surgery has a prohibitive risk. We report the case of a 75-year-old man with a sinotubular junction pseudoaneurysm, likely developed after coronary artery bypass grafting, which was successfully treated by implanting a multifenestrated cribriform septal occluder, a device already used in few similar cases. < Aortic pseudoaneurysm could be a consequence of several types of aortic injuries. In frail patients endovascular approach represents a viable option instead of surgical repair. Such percutaneous treatment has to be individualized also according to the lesion location and size, as in our case where a sinotubular junction pseudoaneurysm was successfully treated by implanting a multifenestrated cribriform septal occluder.>.
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http://dx.doi.org/10.1016/j.jccase.2019.11.009DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7125363PMC
April 2020

Long-Term Follow-Up of Transcatheter Aortic Valve Implantation With Portico Versus Evolut Devices.

Am J Cardiol 2020 04 30;125(8):1209-1215. Epub 2020 Jan 30.

Unità Operativa di Interventistica Cardiovascolare, Pineta Grande Hospital, Castel Volturno, Italy.

New-generation devices such as Evolut and Portico have provided favorable results in patients who underwent transcatheter aortic valve implantation (TAVI) for aortic stenosis, but their comparative effectiveness remains debated, despite its relevance when envisioning TAVI in low-risk patients. We evaluated the safety and efficacy of 2 leading TAVI devices (Evolut and Portico) used by the same team of experienced TAVI operators, focusing on long-term outcomes, including major adverse events (i.e., the composite of death, stroke, myocardial infarction, major vascular complication, or major bleeding). Unadjusted and propensity score-adjusted analyses were carried out. A total of 233 patients were included, 119 (51.1%) receiving Evolut and 114 (49%) Portico. Baseline and procedural data showed significant between-device differences, including functional class, surgical risk, chronic obstructive pulmonary disease, renal function, transesophageal guidance, device size, postdilation, and procedural time (all p <0.05). Yet, acute and in-hospital outcomes were not significantly different (all p >0.05). Follow-up status was ascertained in 228 (98%) patients after 15.0 ± 7.6 months. Unadjusted analysis showed similar rates of major adverse events, as well as the individual risk of death, stroke, myocardial infarction, major vascular complication, major bleeding, and pacemaker implantation (all p >0.05). Even at propensity score-adjusted analysis outcomes were not significantly different with Evolut and Portico (all p >0.05). In conclusion, Evolut and Portico devices yield similarly favorable results at long-term follow-up when used by experienced TAVI operators.
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http://dx.doi.org/10.1016/j.amjcard.2020.01.018DOI Listing
April 2020

Comparative one-month safety and effectiveness of five leading new-generation devices for transcatheter aortic valve implantation.

Sci Rep 2019 11 19;9(1):17098. Epub 2019 Nov 19.

Department of Medico-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Latina, Italy.

Transcatheter aortic valve implantation (TAVI) for aortic stenosis is becoming an appealing alternative to surgical aortic valve replacement in high-risk patients and to medical therapy for inoperable ones. Several new-generation TAVI devices have been recently introduced, but comparative analyses are lacking. We aimed to compare 1-month outcomes associated with such five leading new-generation TAVI devices exploiting data collected in the prospective observational RISPEVA (Registro Italiano GISE sull'impianto di Valvola Aortica Percutanea) Study. We queried the dataset of the ongoing RISPEVA study to retrieve baseline, procedural and 1-month outcome details of patients undergoing TAVI with Acurate, Evolut, Portico, Lotus, and Sapien3. Analysis was based on unadjusted and propensity score-adjusted methods. We included 1976 patients, 234 (11.8%) treated with Acurate, 703 (35.6%) with Evolut, 151 (7.6%) with Lotus, 347 (17.6%) with Portico, and 541 (27.4%) with Sapien3. Unadjusted analysis for baseline features highlighted several significant differences, and other discrepancies were found for procedural features. Despite these differences, device and procedural success were similarly high (ranging from 98.0% to 99.4%, p > 0.05). However, procedural valve migration appeared more common with Acurate (p = 0.007), and major bleeding with Sapien3 (p = 0.002). Unadjusted analysis for 1-month outcomes also highlighted significant differences in the composite of death, stroke, myocardial infarction, major vascular complication, major bleeding, or renal failure (favoring Portico, p < 0.001), major vascular complications (favoring Lotus, p < 0.001), renal failure (favoring Portico, p = 0.035), and permanent pacemaker implantation (favoring Acurate, p < 0.001). Propensity score-adjusted analyses showed lower rates of major adverse events with Evolut and Portico (p < 0.05), major vascular complications with Lotus and Portico (p < 0.05), renal failure with Sapien3 (p < 0.05) and permanent pacemaker implantation with Acurate (p < 0.05). In conclusion, new-generation TAVI devices have different profiles of early comparative safety and efficacy. These findings should be taken into account for individualized decision making and patient management.
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http://dx.doi.org/10.1038/s41598-019-53081-wDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6864033PMC
November 2019

Comparison of ProGlide vs. Prostar in patients undergoing transcatheter aortic valve implantation.

Minerva Cardioangiol 2019 Dec 25;67(6):443-449. Epub 2019 Oct 25.

Department of Medico-Surgical Sciences and Biotechnologies, Sapienza University, Rome, Italy -

Background: Expanding indications to transcatheter aortic valve implantation (TAVI) warrant meticolous vascular management and minimization of access site complications. Two leading vascular closure devices (VCD) are currently used for TAVI, ProGlide vs. Prostar, but their comparative effectiveness and safety are debated. We aimed at comparing acute and 1-month outcomes of patients undergoing TAVI using as VCD either ProGlide (Perclose) or Prostar (XL).

Methods: The prospective RISPEVA database was queried for baseline, procedural, and outcome details of patients undergoing TAVI and in whom either ProGlide or Prostar had been used as VCD. Outcomes of interest were death, vascular complication, and bleeding, distinguishing specific subtypes. Outcomes were adjudicated according to current Valve Academic Research Consortium definitions.

Results: A total of 1987 subjects were included, 913 (46.0%) receiving ProGlide, and 1074 receiving Prostar (54.0%). Several baseline and procedural differences were evident, including surgical risk, concomitant coronary artery disease, sheath size, use of predilation, and chosen TAVI device (all P<0.05). Periprocedurally, despite similar rates of device success (P=0.262), Prostar was associated with a lower risk of vascular stenosis (P=0.005), but a higher rate of device malfunction (P=0.028). Unadjusted analysis for 1-month outcomes suggested higher rates of major adverse events, any bleeding, major bleeding, and renal failure in patients receiving Prostar (all P<0.05). However, propensity score-adjusted analysis did not confirm any significant differences, suggesting that confounding factors mostly drove unadjusted differences.

Conclusions: Use of ProGlide and Prostar as VCD of choice for TAVI appears similarly safe and effective, despite some potential benefits associated with ProGlide. Further randomized trials are warranted to confirm or disprove these findings.
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http://dx.doi.org/10.23736/S0026-4725.19.05071-0DOI Listing
December 2019

Impact of Tirofiban on Serum Troponin Changes in Patients Undergoing Carotid Artery Stenting: A Propensity Matched Analysis.

Ann Vasc Surg 2020 Apr 17;64:151-156.e2. Epub 2019 Oct 17.

Unità Operativa di Interventistica Cardiovascolare, Presidio Ospedaliero Pineta Grande, Castel Volturno, Italy.

Background: The optional periprocedural antithrombotic management for carotid artery stenting (CAS) is still debated.

Methods: We aimed to compare the procedural and 1-month outlook of patients undergoing CAS with tirofiban as parenteral antiplatelet therapy. We retrospectively compared patients receiving tirofiban during CAS versus those undergoing CAS without tirofiban, using propensity score matching. Ancillary antithrombotic therapy included in all patients aspirin, clopidogrel, and unfractioned heparin. The primary outcome was the change in serum troponin from baseline to postprocedural peak levels. A total of 30 patients undergoing CAS were included, 15 receiving tirofiban on top of heparin and dual oral antiplatelet therapy (DAPT) and 15 receiving only heparin and DAPT. Bail-out use of tirofiban was an exclusion criterion.

Results: Baseline troponin was 3.00 (0.06; 5.20) ng/mL in the tirofiban group vs. 4.6 (0.02; 13.10) ng/mL in the no-tirofiban group (P = 0.229), and postprocedural peak 3.5 (0.06; 5.50) ng/mL vs. 6.30 (0.09; 28.40) ng/mL (P = 0.191). Peak-baseline difference in troponin was lower in the tirofiban group than in the no-tirofiban group: 0.3 (0.00; 1.7) ng/mL vs. 1.3 (0.01; 10.00) ng/mL (P = 0.044); the relative peak-baseline change in troponin was analogously different: 24.3% (0%; 44.7%) vs. 50% (21.3%; 80.0%) (P = 0.039). No case of death, myocardial infarction, stroke, or transient ischemic attack occurred during in-hospital stay or at 1-month follow-up.

Conclusions: Tirofiban during CAS might provide periprocedural myocardial protection and reduce myocardial injury as determined by serial troponin measurements.
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http://dx.doi.org/10.1016/j.avsg.2019.09.011DOI Listing
April 2020

Impact of Insulin-Treated and Noninsulin-Treated Diabetes Mellitus in All-Comer Patients Undergoing Percutaneous Coronary Interventions With Polymer-Free Biolimus-Eluting Stent (from the RUDI-FREE Registry).

Am J Cardiol 2019 11 23;124(10):1518-1527. Epub 2019 Aug 23.

Invasive Cardiology Unit, "Pineta Grande" Hospital, Castel Volturno, Caserta, Italy.

Patients with diabetes mellitus (DM) have worse outcomes after percutaneous coronary intervention (PCI). Recent evidences suggest a differential impact of insulin-treated and noninsulin-treated DM on prognosis. We evaluated the clinical outcome of diabetic patients after PCI with polymer-free biolimus-eluting stent from the RUDI-FREE Registry, investigating a possible different prognostic impact of insulin-treated and noninsulin-treated DM. A total of 1,104 consecutive patients who underwent PCI with polymer-free biolimus-eluting stent, enrolled in the RUDI-FREE observational, multicenter, single-arm registry, were stratified by diabetic status; diabetic population was further divided on the basis of insulin treatment. Primary end points of the study were target lesion failure (TLF; composite of cardiac death, target vessel myocardial infarction, target lesion revascularization) and major adverse cardiac and cerebrovascular events (composite of cardiac death, stroke, and myocardial infarction). Multiple ischemic adverse events were also single-handedly considered as secondary end points. At 1 year, TLF was significantly higher in the diabetic cohort, as compared with nondiabetic patients (6.0% vs 3.1%, p 0.022). None of the end points resulted significantly different between nondiabetics and noninsulin-treated diabetic patients. Divergently, compared with nondiabetic, insulin-treated diabetic patients faced significant higher rates of TLF (10.8% vs 3.1%, p 0.003), major adverse cardiac and cerebrovascular events (10.8% vs 3.4%, p 0.004), and of most of the analyzed adverse events. In conclusion, patients with DM had a higher risk of TLF compared with nondiabetics; nonetheless, the worse outcome of the diabetic population seems to be driven by the insulin-treated diabetic subpopulation. This finding suggests a different risk profile of insulin-treated and noninsulin-treated diabetic patients in the modern era of PCI.
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http://dx.doi.org/10.1016/j.amjcard.2019.08.015DOI Listing
November 2019