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1.
Circ Cardiovasc Interv ; 12(9): e008045, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31514524

RESUMO

BACKGROUND: Radial artery occlusion (RAO) is a thrombotic complication of transradial catheterization that can lead to permanent occlusion of the radial artery. Sheath-vessel diameter ratio, postprocedure compression time, occlusive hemostasis, and insufficient anticoagulation are all predictors of RAO. However, excessive anticoagulation can lead to longer time to achieve complete hemostasis and less patent hemostasis rate. This study was designed to assess the relationship among residual anticoagulation at the end of a percutaneous coronary procedure and the risk of RAO. METHODS: Eight hundred thirty-seven patients undergoing transradial catheterization were enrolled. Activated clotting time (ACT) was measured before sheath removal. Patients were divided into 3 groups according to ACT values (ACT <150 s, ACT between 150 and 249 s, ACT >250 s), patent hemostasis with reverse Barbeau test was attempted in all patients, and compression device removed as soon as possible. Within 24 hours, patency of radial artery was checked by Doppler using reverse Barbeau technique. RESULTS: Incidence of RAO was higher for the extreme ACT values. Patent hemostasis were less frequently obtained and time to hemostasis significantly longer for increasing ACT values (P=0.004 for trend and <0.0001 for trend, respectively). At logistic regression analysis, ACT values <150 s were an independent predictor of RAO (odds ratio, 3.53; 95% IC, 1.677-7.43; P=0.001) while adjusted probability for RAO confirmed U-shaped relationship with ACT values. CONCLUSIONS: The level of anticoagulation is strongly related to incidence of RAO and should be measured objectively by ACT. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02762344.

2.
Artigo em Inglês | MEDLINE | ID: mdl-31449176

RESUMO

: Takotsubo cardiomyopathy, also known as 'Broken Heart Syndrome', is a form of acute heart failure, featured by a reversible impairment in cardiac contractility. About 20% of patients during hospitalization experience complications including cardiogenic shock, stroke, left ventricular thrombosis or death. Ventricular rupture has already been reported in Takotsubo cardiomyopathy in patients with typical apical ballooning pattern. We report one of the first cases of a midventricular ballooning Takotsubo cardiomyopathy in a 57-year-old woman complicated by ventricular septal rupture, successfully repaired with a surgical interrupted suture technique.

3.
Heart Rhythm ; 2019 Aug 10.
Artigo em Inglês | MEDLINE | ID: mdl-31404660

RESUMO

BACKGROUND: In recent years, upgrade and revision procedures of cardiac implantable electronic devices (CIEDs) have become increasingly frequent. Patency of the access veins is critical for procedural success. OBJECTIVE: The purpose of this study was to determine the incidence of venous obstruction at the time of system revision, to identify predictors of venous stenosis, and to evaluate the efficacy and safety of percutaneous techniques for overcoming stenosis. METHODS: All patients admitted to our division from January 2004 to January 2017 for CIED revision with the intent to add 1 or more leads were included. Each patient underwent ipsilateral contrast venography. The degree of venous stenosis was determined with the support of quantitative coronary angiography and categorized as significant (75%-90%), subocclusive (90%-99%), or occlusive (100%). RESULTS: Of 227 patients, 61 (27%) showed a stenosis >75%. Different techniques were performed to overcome stenosis: direct vein access, distal venous puncture central to the stenosis, and percutaneous venoplasty in 25 (41%), 26 (43%) and 9 (15%) cases. respectively. All procedures were successful, without major complications. At multivariate analysis, having 3 leads before revision (odds ratio 0.444; 95% confidence interval 0.212-0.920; P = .029) and a previous system revision with lead insertion (odds ratio 0.323; 95% confidence interval 0.124-0.841; P = .021) were independent predictors of venous stenosis. CONCLUSION: Chronic venous obstruction is a relatively frequent finding after CIED implantation. The number of implanted leads seems to be an independent predictor of venous obstruction. In case of stenosis, the preprocedural angiography-guided structured approach allowed preservation of both contralateral access and functioning leads.

6.
EuroIntervention ; 2019 Jul 02.
Artigo em Inglês | MEDLINE | ID: mdl-31270037

RESUMO

AIMS: To prospectively assess clinical benefits of fractional flow reserve (FFR) in guiding coronary artery bypass grafting (CABG). METHODS AND RESULTS: GRAFFITI is a single-blinded prospective multicenter randomized controlled trial for FFR-guided versus angiography-guided CABG. We enrolled patients, undergoing coronary angiography, having significantly diseased left anterior descending or left main stem and at least one more major coronary artery with intermediate stenosis, assessed by FFR. Surgical strategy was defined based on angiogram, blinded to FFR values prior to randomization. After randomization, patients were either operated following the angiogram-based strategy (Angiography-guided group) or according to FFR: i.e. with FFR≤0.80 as cut-off for grafting (FFR-guided group). Primary endpoint was graft patency at 12 months. Trial was registered (NCT01810224). Between March 2012 and December 2016, 172 patients were randomized either to angiography-guided (84 patients) or to FFR-guided group (88 patients). Patients had median of 3 [3;4] lesions. Diameter stenosis was 65% [50%;80%], FFR was 0.72 [0.50;0.82]. Compared to angiography-guided group, FFR-guided group received less anastomoses (3 [3;3] vs. 2 [2;3] respectively; p=0.004). One-year angiographic follow-up showed no difference in overall graft patency (126 [80%] vs 113 [81%], respectively; p=0.885). One-year clinical follow-up, available in 98% of patients, showed no difference in composite of death, myocardial infarction, target vessel revascularization and stroke. CONCLUSIONS: FFR-guidance of CABG has no impact on 1-year graft patency, but it is associated with a simplified surgical procedure.

7.
Int J Cardiol ; 293: 84-90, 2019 Oct 15.
Artigo em Inglês | MEDLINE | ID: mdl-31174920

RESUMO

Percutaneous coronary intervention (PCI) is establishing as the last remaining revascularization option in an increasing number of patients affected by complex coronary artery disease not suitable for surgery. Over the past decade, percutaneous left ventricular assist device (pLVAD) has increasingly replaced intra-aortic balloon pump to provide hemodynamic support during such non-emergent complex high-risk indicated procedures (CHIP) averting the risk of circulatory collapse and of adverse events in long lasting and/or complicated procedures. This review article aims to report the key factors to define CHIP, to summarize the available pLVAD which have CE mark for temporary mechanical LV support and to discuss the rationale of their use in this subset of patients. Based on the expertise of the Italian Society of Interventional Cardiology working group, with the endorsement from Spanish and Portuguese Society of Interventional Cardiology working groups, it will provide several practical suggestions in regards to the use of pLVAD in different clinical CHIP scenarios.

8.
Artigo em Inglês | MEDLINE | ID: mdl-31204242

RESUMO

PURPOSE: Little is known on the impact of contrast-induced acute kidney injury (CI-AKI) on mid- and long-term renal function after percutaneous coronary procedure. The aim of the study was to investigate the incidence of persistent renal damage (PRD) after CI-AKI in a cohort of patients undergoing coronary angiography and/or intervention. Moreover, we sought to assess the predictive value of small creatinine change at 12-24 h (SCrΔ%12-24 h) from contrast exposure in predicting CI-AKI and PRD. METHODS: Complete clinical and biochemical data of 731 patients were retrospectively analyzed at sequential time intervals at baseline, 12-24 h and 48-72 h from the procedure. Data at 30 ±â€¯10 days and 12-24 months were available in 59% and 49% of the cases respectively. Logistic regression was used to assess variables associated with CI-AKI and PRD. ROC analysis was used to test the diagnostic accuracy of SCrΔ%12-24 h in predicting CI-AKI and PRD. RESULTS: CI-AKI occurred in 130/731 patients (17.8%). At 30 ±â€¯10 days PRD occurred in 54.8% patients who developed CI-AKI. A SCrΔ%12-24 h >5% demonstrated independent predictive value (OR = 1.05, CI = 1.04-1.06, p < 0.001) and fair accuracy (AUC = 0.80, CI = 0.77-0.84) for CI-AKI. CONCLUSION: CI-AKI was associated with PRD in >50% of the cases in this single centre cohort. A small and early SCrΔ%12-24 h demonstrated high predictive value for CI-AKI and may be used as a useful tool to unmask a group of patients at risk for PRD after percutaneous coronary procedures.

9.
Kardiol Pol ; 77(6): 589-595, 2019 06 25.
Artigo em Inglês | MEDLINE | ID: mdl-31095122

RESUMO

Cardiogenic shock (CS) is a low cardiac-output state resulting in end-organ hypoperfusion and hypoxia that if untreated leads to an irreversible condition of multi-organ failure. Acute coronary syndrome (ACS) is the most common cause of CS, with a high prevalence of patients with multi vessels disease. Cardiogenic shock management remains a challenge since mortality rates are still high and have not declined over the last 20 years. The treatment strategy of CS in patients with ACS needs to take into account both the presence of myocardial ischemia and tissue hypoperfusion. The first part of the review will focus on the characteristics, the hemodynamic profile and the evidence available of the mechanical circulatory support devices for an optimal patient-device matching. The second part will focus on the management strategy of CS in terms of myocardial revascularization and hemodynamic support in light of the most recent available evidence.

10.
Artigo em Inglês | MEDLINE | ID: mdl-31119562

RESUMO

The reliability of fractional flow reserve (FFR) in aortic stenosis (AS) has been questioned because of the uncertain response to vasodilators. A retrospective multicenter cohort of 114 AS patients who underwent coronary physiology assessment was compared with 154 controls before and after propensity matching adjustment. The difference between resting distal coronary vs aortic pressure ratio (Pd/Pa) and FFR (ΔPd/Pa-FFR) was tested against the severity of AS. ΔPd/Pa-FFR was not influenced by the severity of AS in terms of aortic valve area (r = - 0.02, p = 0.83) and gradient (r = - 0.05, p = 0.64) or by the left ventricle hypertrophy (r = - 0.03, p = 0.88). Conversely, ΔPd/Pa-FFR was influenced by the presence of diabetes (r = - 0.24, p = 0.005), peripheral vascular disease (r = - 0.16, p = 0.047), and chronic kidney disease (r = - 0.19, p = 0.03). No significant difference was observed in the ΔPd/Pa-FFR between patients with AS and matched controls. Further studies are warranted to validate the FFR-guided revascularization in patients with AS.

11.
Int J Cardiol ; 290: 21-26, 2019 Sep 01.
Artigo em Inglês | MEDLINE | ID: mdl-31104821

RESUMO

BACKGROUND: Large prospective studies on the use of bioresorbable vascular scaffolds (BVS) for diffuse coronary artery disease are lacking. IT DISAPPEARS is a large multicentre prospective registry investigating the short and long-term outcomes of everolimus-eluting BVS in patients with long coronary lesions and/or multivessel coronary artery disease (ClinicalTrials.gov: NCT02004730). We hereby report the 2-year outcomes of the registry. METHODS: We enrolled 1002 patients with complex lesions undergoing implantation of 2040 BVS with a prespecified technique including predilation, correct sizing, and postdilation with non-compliant balloons. The primary endpoint was the rate of device-oriented composite endpoint (DOCE), consisting of cardiac death, target vessel-related myocardial infarction (MI), and ischaemia-driven target lesion revascularization (TLR). Secondary endpoints included: 1) patient-oriented composite endpoint (POCE), consisting of all-cause mortality, all infarctions and all revascularisations; 2) definite/probable scaffold thrombosis. RESULTS: Clinical presentation was an acute coronary syndrome in 59.8% of patients. Total BVS length implanted was 47 ±â€¯22 mm. Postdilation of all scaffolds per patient was performed in 96.8%, while optimal implantation as per study guidelines was applied in 71.4%. Through 2-year follow-up, DOCE occurred in 9.5% of patients (cardiac death 0.6%, target vessel-related MI 5.3%, TLR 6.6%). The rate of POCE was 16.6% and of scaffold thrombosis 1.1%. Female gender, total length of coronary lesions, treatment of bifurcation lesions and use of 2.5 mm scaffolds were independent predictors of DOCE. CONCLUSIONS: The 2-year results of IT-DISAPPEARS show that BVS may yield acceptable clinical outcomes in patients with complex coronary lesions when the implantation technique is appropriate.

12.
JACC Cardiovasc Interv ; 12(10): 911-920, 2019 May 27.
Artigo em Inglês | MEDLINE | ID: mdl-31122347

RESUMO

OBJECTIVES: This study aimed to compare differences in patient characteristics and clinical outcomes of nonagenarians undergoing transcatheter aortic valve replacement (TAVR) versus patients younger than 90 years of age and to test the predictive accuracy of the logistic EuroSCORE (European System for Cardiac Operative Risk Evaluation), the EuroSCORE II, and the STS-PROM (Society of Thoracic Surgeons Predicted Risk of Mortality) for mortality after TAVR in nonagenarians. BACKGROUND: The prevalence of severe aortic valve stenosis is increasing due to the rising life expectancy. However, there are limited data evaluating outcomes in patients older than 90 years of age. Moreover, the predictive accuracy of risk scores for mortality has not been evaluated in nonagenarian patients undergoing transfemoral TAVR. METHODS: The CENTER (Cerebrovascular EveNts in Patients Undergoing TranscathetER Aortic Valve Implantation) collaboration (N = 12,381) is an international collaboration consisting of 3 national registries, 6 local or multicenter registries, and 1 prospective clinical study, selected through a systematic online search. The primary endpoint of this study was the difference in 30-day all-cause mortality and stroke after TAVR in nonagenarians versus patients younger than 90 years of age. Secondary endpoints included differences in baseline characteristics, in-hospital outcomes, and the differences in predictive accuracy of the logistic EuroSCORE, the EuroSCORE II, and STS-PROM. RESULTS: A total of 882 nonagenarians and 11,499 patients younger than 90 years of age undergoing transfemoral TAVR between 2007 and 2018 were included. Nonagenarians had considerably fewer comorbidities than their counterparts. Nevertheless, rates of 30-day mortality (9.9% vs. 5.4%; relative risk [RR]: 1.8; 95% confidence interval [CI]: 1.4 to 2.3; p = 0.001), in-hospital stroke (3.0% vs. 1.9%; RR: 1.5; 95% CI: 1.0 to 2.3; p = 0.04), major or life-threatening bleeding (8.1% vs. 5.5%; RR: 1.6; 95% CI: 1.1 to 2.2; p = 0.004), and new-onset atrial fibrillation (7.9% vs. 5.2%; RR: 1.6; 95% CI: 1.1 to 2.2; p = 0.01) were higher in nonagenarians. The STS-PROM adequately estimated mortality in nonagenarians, with an observed-expected mortality ratio of 1.0. CONCLUSIONS: In this large, global, patient-level analysis, mortality after transfemoral TAVR was 2-fold higher in nonagenarians compared with patients younger than 90 years of age, despite the lower prevalence of baseline comorbidities. Moreover, nonagenarians had a higher risk of in-hospital stroke, major or life-threatening bleeding, and new-onset atrial fibrillation. The STS-PROM was the only surgical risk score that accurately predicted the risk of mortality in nonagenarians.

13.
Cardiovasc Toxicol ; 2019 May 02.
Artigo em Inglês | MEDLINE | ID: mdl-31049776

RESUMO

Diagnosis and management of Cancer therapeutics-related cardiac dysfunction is of crucial importance in breast cancer (BC) patients. The role of advanced echocardiographic techniques, such as deformation imaging, in the diagnosis and characterization of patients receiving cancer therapy has so far involved relatively small studies in the research setting. Therefore, we conducted a meta-analysis and systematic review of observational studies evaluating myocardial changes during chemotherapy detected through conventional echocardiographic parameters, such as 2D left ventricular ejection fraction (2D LVEF), and 2D Speckle tracking echocardiography (STE). The literature search retrieved 487 research works, articles, of which 17 were found to be pertinent with this topic. After full article review, 16 studies were considered suitable for the present analysis. Two separate analyses, one for the anthracyclines-based therapeutic regimen and one for the trastuzumab based therapeutic regimen, were performed. A significant reduction in 2D LVEF and 2D STE parameters during cancer therapy was found in both the investigations. Peak systolic global longitudinal strain demonstrated to be the most consistent 2D STE parameter in detecting early myocardial changes among all the studies. Thus, we confirmed the role of 2D STE for the early detection of myocardial damage, suggesting its crucial role in monitoring BC patients and eventually driving the introduction of cardioprotective treatment.

14.
Int J Cardiol ; 292: 162-165, 2019 Oct 01.
Artigo em Inglês | MEDLINE | ID: mdl-31029497

RESUMO

BACKGROUND: Aortic stenosis (AS) is frequently associated with coronary artery disease (CAD). However, the best tool to functionally assess CAD in AS remains undetermined. Fractional flow reserve (FFR) and instantaneous wave-free ratio (iFR) have never been validated in AS. METHODS: FFR, iFR and stress single photon emission computed tomography (SPECT) were performed in a consecutive series of 28 patients with severe AS and 41 borderline coronary lesions during the work-up for valve replacement. RESULTS: Both FFR and iFR were correlated with an abnormal SPECT. At ROC analysis, FFR yielded an AUC = 0.91 with negative predictive value (NPV) = 95% in detecting ischemia according to SPECT. iFR showed significant worse agreement with myocardial perfusion imaging compared to FFR (59% vs 85%, p = 0.014). Specifically, a significant larger proportion of false positive measurements (negative SPECT and iFR < 0.89) was observed using iFR vs FFR: 39% vs 12%, p = 0.011. Using a pre-specified 0.82 cut-off, the iFR agreement with SPECT increased to 73%. CONCLUSIONS: FFR yielded a good correlation with SPECT and a high NPV in detecting ischemia-provoking lesions. iFR diagnostic metrics were inferior compared with FFR and improved adopting a lower ischemic threshold.

16.
Circ Cardiovasc Interv ; 12(3): e007546, 2019 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-30871358

RESUMO

BACKGROUND: Stroke remains one of the most devastating complications of transcatheter aortic valve implantation (TAVI). The aim of this study was to identify the incidence, timing, temporal trends, and predictors of stroke after TAVI and evaluate the outcomes of patients with stroke. METHODS AND RESULTS: The CENTER-Collaboration is an international collaboration consisting of 3 national registries and 7 local registries or prospective clinical trials, selected through a systematic review. Accordingly, a total of 10 982 patients undergoing transfemoral TAVI between 2007 and 2018 were included in the current patient-level pooled analyses. A total of 261 patients (2.4%) experienced stroke during the first month after TAVI. The median time between TAVI and stroke was 1 day (interquartile range, 0-6 days). The stroke rate was comparable in procedures performed in the early years of TAVI (2007-2012) to those in the more recent years of TAVI (2013-2018; both 2.4%; P=1.0). Independent predictors of stroke at 30 days were a history of cerebrovascular events (odds ratio, 2.2; 95% CI, 1.4-3.6; P=0.0012) and a glomerular filtration rate of <30 mL/min per 1.73 m2 (odds ratio, 1.7; 95% CI, 1.0-2.8; P=0.05). Stroke occurring within the first 30 days after TAVI was associated with a 6-fold increase of 30-day mortality (odds ratio, 6.0; 95% CI, 4.4-8.1; P<0.001). Moreover, patients with stroke more frequently had documented new-onset atrial fibrillation (16% versus 3%; P<0.001) and major or life-threatening bleedings (12% versus 7%; P=0.002) at 30-day follow-up. CONCLUSIONS: In this large, global, patient-level analysis, the incidence of stroke after transfemoral TAVI was 2.4%. Prior cerebrovascular events and a low glomerular filtration rate independently predicted the occurrence of stroke after TAVI. The occurrence of stroke after TAVI was associated with a strikingly 6-fold increase of 30-day mortality; additionally, there was a 5-fold higher rate of new-onset atrial fibrillation in patients with stroke. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT03588247.

17.
Artigo em Inglês | MEDLINE | ID: mdl-30797759

RESUMO

BACKGROUND: Resistive reserve ratio (RRR) is a novel index that expresses the ratio between basal and hyperemic microcirculatory resistance. We sought to compare the performance of RRR, coronary flow reserve (CFR) and index of microcirculatory resistance (IMR) in predicting the extent of infarct size (IS) after ST-elevation myocardial infarction. METHODS: Thermodilution parameters were measured after primary percutaneous coronary intervention (PPCI) in 45 patients. In 30 (67%) cases pre-stenting measurements were also performed to assess the effect of PPCI on myocardial reperfusion, defined by CFR. Cardiovascular magnetic resonance (CMR) was performed at 48-h to assess area-at-risk (AAR), microvascular obstruction (MVO) and IS. CMR was repeated at 6 months in 39/45 patients. RESULTS: RRR (AUCRRR = 0.85, CI: 0.71-0.99) performed better compared to CFR (AUCCFR = 0.67, CI: 0.48-0.86) and IMR (AUCIMR = 0.70, CI: 0.52-0.88) in predicting IS% at 6-months. Patients with impaired RRR showed larger acute-IS% (27.4 [14.5-42.5] vs 15.4 [8.3-26], p = 0.018), MVO% (3.44 [0-5.97] vs 0 [0-0.89], p = 0.026), AAR% (43 [35-52] vs 34 [25-46], p = 0.03) and 6-months-IS% (22.7 [10.2-35] vs 8.8 [6.9-12.3], p = 0.006), higher rate of adverse remodeling (22.2% vs 0%, p = 0.04) and lower myocardial salvage index (34% [22.8-59.2] vs 53.2% [37.7-71], p = 0.032) compared with other patients. Furthermore, RRR but not IMR or CFR resulted independently associated with 6-months-IS%. CFR (1.48 ±â€¯0.87 vs 1.47 ±â€¯0.61, p = 0.94) did not improve after PPCI in patients with impaired RRR, whereas it improved significantly in other patients (CFR: 1.37 ±â€¯0.43 vs 1.93 ±â€¯0.49, p = 0.018). CONCLUSIONS: Patients with post-PPCI impaired RRR were more likely to have suboptimal myocardial reperfusion and larger IS at follow-up. RRR may offer incremental prognostic value compared with other thermodilution-derived indices.

18.
J Am Coll Cardiol ; 73(4): 444-453, 2019 Feb 05.
Artigo em Inglês | MEDLINE | ID: mdl-30704577

RESUMO

BACKGROUND: Physicians are not always comfortable deferring treatment of a stenosis in the left anterior descending (LAD) artery because of the perception that there is a high risk of major adverse cardiac events (MACE). The authors describe, using the DEFINE-FLAIR (Functional Lesion Assessment of Intermediate Stenosis to Guide Revascularisation) trial, MACE rates when LAD lesions are deferred, guided by physiological assessment using fractional flow reserve (FFR) or the instantaneous wave-free ratio (iFR). OBJECTIVES: The purpose of this study was to establish the safety of deferring treatment in the LAD using FFR or iFR within the DEFINE-FLAIR trial. METHODS: MACE rates at 1 year were compared between groups (iFR and FFR) in patients whose physiological assessment led to LAD lesions being deferred. MACE was defined as a composite of cardiovascular death, myocardial infarction (MI), and unplanned revascularization at 1 year. Patients, and staff performing follow-up, were blinded to whether the decision was made with FFR or iFR. Outcomes were adjusted for age and sex. RESULTS: A total of 872 patients had lesions deferred in the LAD (421 guided by FFR, 451 guided by iFR). The event rate with iFR was significantly lower than with FFR (2.44% vs. 5.26%; adjusted HR: 0.46; 95% confidence interval [CI]: 0.22 to 0.95; p = 0.04). This was driven by significantly lower unplanned revascularization with iFR and numerically lower MI (unplanned revascularization: 2.22% iFR vs. 4.99% FFR; adjusted HR: 0.44; 95% CI: 0.21 to 0.93; p = 0.03; MI: 0.44% iFR vs. 2.14% FFR; adjusted HR: 0.23; 95% CI: 0.05 to 1.07; p = 0.06). CONCLUSIONS: iFR-guided deferral appears to be safe for patients with LAD lesions. Patients in whom iFR-guided deferral was performed had statistically significantly lower event rates than those with FFR-guided deferral.

20.
J Am Coll Cardiol ; 73(2): 148-157, 2019 Jan 22.
Artigo em Inglês | MEDLINE | ID: mdl-30654886

RESUMO

BACKGROUND: Transcatheter aortic and pulmonary valves have been used to treat stenosis or regurgitation after prior surgical tricuspid valve (TV) replacement or repair. Little is known about intermediate-term valve-related outcomes after transcatheter tricuspid valve replacement (TTVR), including valve function, thrombus, and endocarditis. OBJECTIVES: The authors sought to evaluate mid-term outcomes in a large cohort of patients who underwent TTVR after surgical TV repair or replacement, with a focus on valve-related outcomes. METHODS: Patients who underwent TTVR after prior surgical TV replacement or repair were collected through an international registry. Time-related outcomes were modeled and risk factors assessed. RESULTS: Data were collected for 306 patients who underwent TTVR from 2008 through 2017 at 80 centers; 52 patients (17%) had a prior history of endocarditis. Patients were followed for a median of 15.9 months after implantation (0.1 to 90 months), with 64% of patients estimated to be alive without TV reintervention or a valve-related event at 3 years. The cumulative 3-year incidence of death, reintervention, and valve-related adverse outcomes (endocarditis, thrombosis, or significant dysfunction) were 17%, 12%, and 8%, respectively. Endocarditis was diagnosed in 8 patients 2 to 29 months after TTVR, for an annualized incidence rate of 1.5% per patient-year (95% confidence interval: 0.45% to 2.5%). An additional 8 patients were diagnosed with clinically relevant valve thrombosis, 3 in the short term, 2 within 2 months, and 3 beyond 6 months. Only 2 of these 8 patients received anticoagulant therapy before thrombus detection (p = 0.13 vs. patients without thrombus). Prior endocarditis was not a risk factor for reintervention, endocarditis, or valve thrombosis, and there was no difference in valve-related outcomes according to TTVR valve type. CONCLUSIONS: TV dysfunction, endocarditis, and leaflet thrombosis were uncommon after TTVR. Patients with prior endocarditis were not at higher risk for endocarditis or other adverse outcomes after TTVR, and endocarditis occurred with similar frequency in different valve types. Though rare, leaflet thrombosis is an important adverse outcome, and further study is necessary to determine the appropriate level of prophylactic therapy after TTVR.

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