Background Long-term effects of Coronavirus Disease of 2019 (COVID-19) and their sustainability are of the utmost relevance. We aimed to determine: 1) functional capacity of COVID-19 survivors by cardiopulmonary exercise testing (CPET); 2) characteristics associated with cardiopulmonary exercise testing (CPET) performance; 3) safety and tolerability of CPET. Methods We prospectively enrolled consecutive patients with laboratory-confirmed COVID-19 discharged alive at Azienda Sanitaria Locale-3, Genoa. At 3-month from hospital discharge, complete clinical evaluation, trans-thoracic echocardiography, CPET, pulmonary function test, and dominant leg extension (DLE) maximal strength evaluation were performed. Results From 225 patients discharged from March to November 2020, we excluded 12 incomplete/missing cases, 13 unable to perform CPET leading to a final population of 200. Median percent-predicted peak oxygen uptake (%pVO2) was 88% (78.3–103.1). Ninety-nine(49.5%) patients had %pVO2 below, whereas 101(50.5%) above the 85% predicted value (indicating normality). Of 61/99 patients with reduced %pVO2 but normal anaerobic threshold, 9(14.8%) had respiratory, 21(34.4%) cardiac, and 31(50.8%) non-cardiopulmonary limitation of exercise. One-hundred sixty(80.0%) patients complain at least one symptom, without relationship with pVO2. Multivariate linear regression analysis showed percent-predicted forced expiratory volume in one-second(β = 5.29, p = 0.023), percent-predicted diffusing capacity of lungs for carbon monoxide(β = 6.31, p = 0.001), and DLE maximal strength(β = 14.09, p = 0.008) independently associated with pVO2. None adverse event was reported during/after CPET neither the involved health professionals developed COVID-19. Conclusions CPET after COVID-19 is safe and about 1/3rd of COVID-19 survivors show functional capacity limitation mainly explained by muscular impairment, calling for future research to identify patients at higher risk of long-term effects that may benefit from careful surveillance and targeted rehabilitation.
IntroductionLong-term effects of Coronavirus Disease of 2019 (COVID-19) and their sustainability in a large number of patients are of the utmost relevance. We aimed to determine: 1)functional capacity of non-severe COVID-19 survivors by cardiopulmonary exercise testing (CPET); 2)those characteristics associated with worse CPET performance.MethodsWe prospectively enrolled the first 150 consecutive subjects with laboratory-confirmed COVID-19 infection discharged alive from March to April 2020 at Azienda Sanitaria Locale (ASL)3, Genoa, Italy. At 3-month from hospital discharge, complete clinical evaluation, trans-thoracic echocardiography, cardiopulmonary exercise testing (CPET), pulmonary function test (PFT), and dominant leg extension (DLE) maximal strength evaluation were performed.ResultsExcluding severe and incomplete/missing cases, 110 patients were analyzed. Median percent predicted peak oxygen uptake (%pVO2) was 90.9(79.2-109.0)%. Thirty-eight(34.5%) patients had %pVO2 below, whereas 72(65.5%) above the 85% predicted value (indicating normality). Median PFT parameters were within normal limits.Eight(21.1%) patients had a mainly respiratory, 9(23.7%) a mainly cardiac, 3(7.9%) a mixed-cardiopulmonary, and 18(47.4%) a non-cardiopulmonary limitation of exercise. Eighty-one(73.6%) patients experimented at least one symptom, without relationship with %pVO2 (p>0.05).Multivariate linear regression analysis showed age (β=0.46, p=0.020), percent weight loss (β=-0.77, p=0.029), active smoke status (β=-7.07, p=0.019), length of hospital stay (β=-0.20, p=0.042), and DLE maximal strength (β=1.65, p=0.039) independently associated with %pVO2.ConclusionsHalf of non-severe COVID-19 survivors show functional capacity limitation mainly explained by muscular impairment, albeit cardiopulmonary causes are possible. These findings call for future research to identify patients at higher risk of long-term effects, that may benefit from careful surveillance and targeted rehabilitation.Take-home messagesat 3-month cardiopulmonary exercise testing 38/110(34.5%) non-severe COVID-19 survivors had percent predicted peak oxygen uptake (%pVO2) < 85% (indicating normality). Half of them had functional capacity limitation mainly explained by muscular impairment.
Aim To provide an updated assessment of the efficacy–safety profile of very short (1 or 3 months) dual antiplatelet therapy (DAPT) compared with long (12 months) DAPT in patients undergoing percutaneous coronary interventions (PCIs). Methods and results Seven randomized controlled trials (RCTs) comparing very short vs. long DAPT in 35 785 patients undergoing PCI were selected. The primary efficacy endpoint was major adverse cardiovascular events (MACE) and the primary safety endpoint trial-defined major bleeding through at least 1 year. Compared with longer duration, very short DAPT yielded comparable rates of MACE [odds ratio (OR) 0.93, 95% confidence interval (CI) 0.84–1.03, P = 0.19], all-cause mortality (OR 0.92, 95% CI 0.80–1.06, P = 0.25), myocardial infarction (OR 1.01, 95% CI 0.88–1.15, P = 0.91), stroke (OR 1.04, 95% CI 0.72–1.50, P = 0.83), stent thrombosis (OR 1.05, 95% CI 0.80–1.37, P = 0.73), target vessel revascularization (OR 0.99, 95% CI 0.82–1.18, P = 0.89), and comparable net clinical benefit (OR 0.92, 95% CI 0.84–1.01, P = 0.08). Very short DAPT was associated with reduced rates of major bleeding (OR 0.61, 95% CI 0.40–0.94, P = 0.03) or any bleeding (OR 0.65, 95% CI 0.47–0.90, P = 0.009). Subgroup analyses showed consistent results for 1 vs. 3 month DAPT and for aspirin vs. P2Y12 inhibitor monotherapy following very short DAPT. Conclusions Compared with long DAPT, very short DAPT did not increase the odds of ischaemic complications, while reducing the odds of major or any bleeding by over 30%.
Background: The best management of stable coronary artery disease (CAD) in patients undergoing transcatheter aortic valve implantation (TAVI) is still unclear due to the marked inconsistency of the available evidence. Methods: The REVASC-TAVI registry (Management of Myocardial Revascularization in Patients Undergoing Transcatheter Aortic Valve Implantation With Coronary Artery Disease) collected data from 30 centers worldwide on patients undergoing TAVI who had significant, stable CAD at preprocedural work-up. For the purposes of this analysis, patients with either complete or incomplete myocardial revascularization were compared in a propensity score matched analysis, to take into account of baseline confounders. The primary and co-primary outcomes were all-cause death and the composite of all-cause death, stroke, myocardial infarction, and rehospitalization for heart failure, respectively, at 2 years. Results: Among 2407 patients enrolled, 675 pairs of patients achieving complete or incomplete myocardial revascularization were matched. The primary (21.6% versus 18.2%, hazard ratio‚ 0.88 [95% CI, 0.66–1.18]; P =0.38) and co-primary composite (29.0% versus 27.1%, hazard ratio‚ 0.97 [95% CI, 0.76–1.24]; P =0.83) outcome did not differ between patients achieving complete or incomplete myocardial revascularization, respectively. These results were consistent across different prespecified subgroups of patients (< or >75 years of age, Society of Thoracic Surgeons score > or <4%, angina at baseline, diabetes, left ventricular ejection fraction > or <40%, New York Heart Association class I/II or III/IV, renal failure, proximal CAD, multivessel CAD, and left main/proximal anterior descending artery CAD; all P values for interaction >0.10). Conclusions: The present analysis of the REVASC-TAVI registry showed that, among TAVI patients with significant stable CAD found during the TAVI work-up, completeness of myocardial revascularization achieved either staged or concomitantly with TAVI was similar to a strategy of incomplete revascularization in reducing the risk of all cause death, as well as the risk of death, stroke, myocardial infarction, and rehospitalization for heart failure at 2 years, regardless of the clinical and anatomical situations.
Background Acute kidney injury (AKI) after transcatheter aortic valve replacement (TAVR) is associated with increased mortality. However, it is controversial whether AKI affects prognosis per se, being linked to baseline chronic kidney disease (CKD) and bleeding complications. The aim of this study was to disentangle, applying mediation analysis, the association between AKI and clinical outcome, considering CKD and bleedings. Methods and Results Consecutive patients undergoing TAVR were prospectively enrolled at 5 high‐volume centers in Italy. AKI was defined according to Valve Academic Research Consortium‐3 consensus, whereas bleeding with Bleeding Academic Research Consortium. Primary outcome was all‐cause mortality after 1‐year follow‐up. Among 2621 patients undergoing TAVR, AKI occurrence was associated with 1‐year mortality. This association of AKI with the primary end points remained significant after adjusting for baseline risk estimators, either Society of Thoracic Surgeons score (hazard ratio [HR], 2.78 [95% CI, 1.95–3.80], P <0.001) or EuroSCORE‐II (HR, 1.85 [95% CI, 1.35–2.56], P <0.001). Both AKI and CKD significantly and independently affected primary outcome (HR, 3.06 [95% CI, 2.01–4.64], P <0.001 and HR, 1.82 [95% CI 1.27–2.65], P <0.01, respectively). The estimated proportion of the total effect of CKD mediated via AKI was, on average, 15%, 95% CI, 4%–29%, P <0.001. The significant effect of Bleeding Academic Research Consortium 2–5 bleedings on the primary outcome was not mediated by AKI. Conclusions AKI occurs in 1 out of 6 patients and significantly mediates one fifth of the effect of baseline CKD on all‐cause mortality after TAVR. Our analysis supports a systematic effort to prevent AKI during TAVR, which may potentially translate into improved patients' 1‐year survival.
Aims Acute kidney injury (AKI) may complicate transcatheter aortic valve replacement (TAVR) leading to higher mortality. The relationship between AKI, obesity, and mortality, however, is controversial. We sought to investigate the impact of body habitus on the prognostic value of AKI in TAVR. Methods Among the 645 patients who underwent successful TAVR in a single high-volume centre, we retrospectively evaluated the association between AKI-TAVR and 30-day, 6-month, and 1-year mortality, and whether this relationship was affected by BMI. AKI was defined according to the Valve Academic Research Consortium-2 criteria. Patients were categorized into three groups by BMI: low-to-normal weight (<25 kg/m2), overweight (25–30 kg/m2), obese (>30.0 kg/m2). Results Three-hundred and twenty-four (50.2%) patients were low-to-normal weight, 223 (34.6%) overweight, and 98 (15.2%) obese. AKI occurred in 141 (21.9%), similarly across BMI groups. Thirty-day, 6-month, and 1-year mortality rates were 2.2, 3.7, and 7.9%, without differences across BMI groups. Among patients who developed AKI-TAVR, 30-day (8.7 vs. 2.0 vs. 0.0%), 6-month (13.0 vs. 6.1 vs. 4.3%), and 1-year (20.3 vs. 12.2 vs. 4.3%) mortality showed a decreasing trend across increasing BMI categories (all P < 0.05); the same trend was not observed for patients without AKI-TAVR. In multivariate models, AKI was associated with 30-day [odds ratio (OR): 2.46, 95% confidence interval (CI): 1.70–8.67], 6-month (OR: 2.75, 95% CI: 1.32–7.59), and 1-year mortality (OR: 1.84, 95% CI: 1.22–3.71, all P < 0.05). The interaction between AKI and BMI, when added to the models, was consistently significant (all P < 0.05). Conclusion Higher BMI is associated with better survival in TAVR patients who develop AKI.
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