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3.
Int J Cardiol ; 342: 65-71, 2021 Nov 01.
Artigo em Inglês | MEDLINE | ID: mdl-34375704

RESUMO

BACKGROUND: We aimed at appraising features and outcomes of patients undergoing MitraClip treatment according to their age. METHODS: We queried the prospective GIse registry Of Transcatheter treatment of mitral valve regurgitaTiOn (GIOTTO) multicenter registry dataset including 19 Italian centers performing MitraClip implantation, distinguishing patients <80 vs ≥80 years of age. RESULTS: In total, 1853 patients were included, 751 (40.5%) octogenarians and 1102 (59.5%) non-octogenarians. Several baseline and procedural features were significantly different, including gender, regurgitation etiology, and functional class (all p < 0.05). In-hospital outcomes were similarly satisfactory, with death occurring in 18 (2.4%) and 32 (2.9%, p = 0.561), respectively, and improvement in mitral regurgitation in 732 (97.4%) and 1078 (97.8%, p = 0.746), respectively. After a mean follow-up of 15 months, death occurred in 152 (20.2%) and 264 (24.0%), and cardiac death in 85 (11.3%) and 138 (12.5%), respectively (both p > 0.05). Rehospitalization for heart failure and the composite of cardiac death or rehospitalization for heart failure were significantly less common in octogenarians: 63 (8.4%) vs 156 (14.2%, p < 0.001), and 125 (16.6%) vs 242 (22.0%, p = 0.005), respectively. Multivariable analysis showed that these differences were largely due to confounding features, as after adjustment for baseline, clinical and imaging characteristics no significant difference was found for the above clinical endpoints. CONCLUSIONS: Transcatheter mitral valve repair with the MitraClip in carefully selected octogenarians appears feasible and safe, and is associated with favorable clinical outcomes at mid-term follow-up.

4.
Artigo em Inglês | MEDLINE | ID: mdl-34463427

RESUMO

OBJECTIVES: To asses mid-term clinical outcomes of bioresorbable vascular scaffolds (BVS) for the treatment of coronary artery disease in a large-scale all-comers population. BACKGROUND: Several clinical settings are underrepresented in randomized studies investigating BVS against drug-eluting stents. Whether their results can be translated into the heterogeny patient population seen during daily routine requires further investigation. METHODS: The European ABSORB Consortium comprises the following European registries: GABI-R, ABSORB UK Registry, ABSORB France, BVS RAI Registry, and REPARA BVS Registry, which all prospectively collected patient-level data regarding outcomes following unrestricted BVS implantation. The primary endpoint of target lesion failure (TLF) includes cardiac death, target-vessel myocardial infarction (TVMI) and target-lesion revascularisation (TLR) at 12 months. The incidence of scaffold thrombosis (ST) according to ARC criteria was also assessed. Multivariable analysis was used to adjust for differences in patient and lesion characteristics. RESULTS: A total of 10,312 patients (mean age 58.4 ± 11.4 y) underwent BVS implantation during routine practice. The 12-month follow-up was complete in 95.5% of patients. At 12 months, the primary endpoint of TLF occurred in 3.6%; its components cardiac death, TVMI and TLR were documented in 1.2%, 1.8%, and 2.6%, respectively. The definite/probable ST rate was 1.7%. Absence of predilatation, discontinuation of DAPT and scaffold diameter below 3 mm were independent predictors of ST. CONCLUSIONS: The EAC demonstrates reasonable real-world clinical outcome data after BVS implantation. However, the rate of scaffold thrombosis remains high.

7.
Artigo em Inglês | MEDLINE | ID: mdl-34389852

RESUMO

AIMS: To report the incidence, the predictors and clinical impact of device-related complications (DRCs) in the IMP-IT (IMPella Mechanical Circulatory Support Device in Italy) registry. Impella is percutaneous left ventricular assist devices, which provides mechanical circulatory support both in cardiogenic shock (CS) and high-risk percutaneous coronary intervention (HR-PCI). The IMP-IT registry is a multicentre registry evaluating the trends in use and clinical outcomes of Impella in Italy. METHODS AND RESULTS: A total of 406 patients have been included in this registry: 56.4% in the setting of CS, while 43.6% patients in the setting of HR-PCI. DRCs were defined as a composite endpoint of access-site bleeding, limb ischaemia, vascular complication requiring treatment, haemolysis, aortic injury, and left ventricular perforation. DRC incidence in the overall population was 25.6%, with significantly higher rate in the CS (37.1%) than in the HR-PCI (10.7%) group. The most frequent complication was haemolysis (11.8%), which occurred almost exclusively in CS population. Access-site bleeding was observed in 9.6% of the overall population, with no significant difference between the two groups. Limb ischaemia was observed in 8.3% of the overall population, with significantly higher rate in the CS group. CS and right ventricular dysfunction appear as the strongest independent predictors of DRC. One-year mortality in patients with DRC appears higher than in patients with no DRC. However, DRC was not confirmed as an independent predictor of 1-year mortality at multivariate analysis. CONCLUSION: In the IMP-IT registry, the rate of DRC was 25.6%, with CS being the strongest independent predictor. DRC was not found as an independent predictor of 1-year mortality.

8.
Artigo em Inglês | MEDLINE | ID: mdl-34444637

RESUMO

The present study aimed to analyze sleep quality and quality of Life (QoL) in patients undergoing Transcatheter Aortic Valve Implantation (TAVI). It was conducted at the Interventional Cardiology Unit of the Department of Cardiac, Thoracic, Vascular Sciences and Public Health of the University of Padova on 27 adult patients who underwent TAVI via the transfemoral approach. Patients completed two validated instruments, i.e., the Pittsburgh Sleep Quality Index (PSQI) and the EuroQoL (EQ-5D-5L), on the day of discharge and one month after the hospital discharge. Twenty-seven patients were enrolled with a severe aortic stenosis diagnosis, treated with transfemoral TAVI procedure. The study population included seventeen poor sleepers and ten good sleepers with a median age of 81.92 years overall. The global PSQI evaluation revealed a small significant improvement at follow-up (p-value 0.007). Small positive changes were detected in the Self-care and Usual activity domains of the EQ-5D-5L and the EQ-VAS. No correlation was detected between EQ-5D-5L and sleep quality. The present study confirms the importance of sleep quality monitoring in patients who undergo TAVI procedure for aortic stenosis treatment.


Assuntos
Estenose da Valva Aórtica , Substituição da Valva Aórtica Transcateter , Idoso de 80 Anos ou mais , Estenose da Valva Aórtica/cirurgia , Humanos , Qualidade de Vida , Sono , Substituição da Valva Aórtica Transcateter/efeitos adversos , Resultado do Tratamento
9.
Artigo em Inglês | MEDLINE | ID: mdl-34281108

RESUMO

Wearable devices (WDs) can objectively assess patient-reported outcomes (PROMs) in clinical trials. In this study, the feasibility and acceptability of using commercial WDs in elderly patients undergoing transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) will be explored. This is a prospective observational study. Participants were trained to use a WD and a smartphone to collect data on their physical activity, rest heart rate and number of hours of sleep. Validated questionnaires were also used to evaluate these outcomes. A technology acceptance questionnaire was used at the end of the follow up. In our participants an overall good compliance in wearing the device (75.1% vs. 79.8%, SAVR vs. TAVR) was assessed. Half of the patients were willing to continue using the device. Perceived ease of use is one of the domains that scored higher in the technology acceptance questionnaire. In this study we observed that the use of a WD is accepted in our frail population for an extended period. Even though commercial WDs are not tailored for clinical research, they can produce useful information on patient behavior, especially when coordinated with intervention tailored to the single patient.


Assuntos
Estenose da Valva Aórtica , Implante de Prótese de Valva Cardíaca , Dispositivos Eletrônicos Vestíveis , Idoso , Estenose da Valva Aórtica/cirurgia , Estudos de Viabilidade , Humanos , Medidas de Resultados Relatados pelo Paciente , Fatores de Risco , Resultado do Tratamento
11.
Panminerva Med ; 2021 Jul 26.
Artigo em Inglês | MEDLINE | ID: mdl-34309332

RESUMO

BACKGROUND: Transcatheter mitral valve repair (TMVR) with the MitraClip device is an established treatment for mitral regurgitation (MR). More than one MitraClip may be implanted if a single one does not reduce MR adequately. We aimed at appraising the outlook of patients undergoing implantation of one, two or multiple MitraClips for TMVR. METHODS: Exploiting the ongoing prospective GIse registry Of Transcatheter treatment of mitral valve regurgitaTiOn (GIOTTO) Study dataset, we compared patients, procedural details and outcomes distinguishing those receiving one, two or multiple MitraClips. The primary endpoint was the composite of 1-year cardiac death or rehospitalization for heart failure. Additional endpoints included all cause death, surgical mitral repair, and functional class. Multivariable adjusted Cox proportional hazard analysis was used for confirmatory purposes. RESULTS: As many as 1824 patients were included: 718 (39.4%) treated with a single MitraClip, and 940 (51.5%) receiving two MitraClips, and 166 (9.1%) receiving three or more. Significant differences were found for baseline features, including age, female gender, diabetes mellitus, hypertension, chronic obstructive pulmonary disease, prior myocardial infarction, atrial fibrillation, permanent pacemaker, cardiac resynchronization therapy, implantable cardioverter defibrillator, and prior mitral valve repair (all p<0.05). Several imaging features were also different, including left ventricular dimensions, MR severity and proportionality, mitral valve area, flail leaflet, and pulmonary vein flow (all p<0.05). Among procedural features, significant differences were found for anesthesia type, MitraClip type, fluoroscopy, device, and operating room times, postprocedural mitral gradient, residual MR, smoke-like effect, device success partial detachment and surgical conversion (all p<0.05). In-hospital death occurred more frequently in patients receiving multiple MitraClips, and the same applied severe residual MR (all p<0.05). Mid-term follow-up (15±13 months) showed significant difference in the risk of death, cardiac death, rehospitalization for heart failure, and their composites, mainly, but not solely, associated with multiple MitraClips (all p<0.05). Adjusted analysis confirmed the significantly increased risk of composite adverse events when comparing the multiple vs single MitraClip groups (p=0.014 for death and rehospitalization, p=0.013 for cardiac death or rehospitalization). CONCLUSIONS: Implantation of one or two MitraClips is associated with favorable clinical outcomes. Conversely, bail-out implantation of three or more MitraClips may portend a worse long-term prognosis.

12.
Artigo em Inglês | MEDLINE | ID: mdl-34311063

RESUMO

BACKGROUND: Pulmonary capillary wedge pressure (PCWP) plays a pivotal role in cardiac disease diagnosis and management. Right heart catheterization (RHC) invasively provides accurate PCWP measurement, but it is impractical for widespread use in all patients. The left atrial expansion index (LAEI), measured on transthoracic echocardiography, describes the relative left atrial volume increase during the left atrial reservoir phase. The aim of this study was to validate LAEI as a noninvasive parameter for PCWP estimation. METHODS: A total of 649 chronic cardiac patients (mean age, 66 ± 14 years; mean PCWP, 14 ± 7.6 mm Hg; mean left ventricular ejection fraction, 50 ± 15%) who underwent both clinically indicated RHC and transthoracic echocardiography within 24 hours were retrospectively enrolled. Patients were randomly divided into derivation (n = 509) and validation (n = 140) cohorts. PCWP was measured during RHC and defined as elevated when >12 mm Hg. Transthoracic echocardiographic parameters and LAEI were measured offline, blinded to RHC results. RESULTS: In the derivation cohort, LAEI correlated logarithmically with PCWP, and the log-transformed LAEI (lnLAEI) correlated linearly with PCWP (r = -0.73, P < .001). lnLAEI showed an independent and additive predictive role for PCWP estimation over clinical and diastolic dysfunction (DD) parameters. The diagnostic accuracy of lnLAEI for elevated PCWP identification (area under the curve = 0.875, P < .001; optimal lnLAEI cutoff < 4.02) was higher than either the single DD parameters or their combination. In the validation cohort, lnLAEI cutoff < 4.02 showed higher accuracy than the 2016 DD algorithm (88% vs 74%) for elevated PCWP identification. Finally, the equation PCWP = 38.3 - 6.2 × lnLAEI, obtained from the derivation cohort, predicted invasively measured PCWP in the validation cohort. CONCLUSIONS: In a cohort of patients with various chronic cardiac diseases, lnLAEI performed better than DD parameters and the 2016 DD algorithm for PCWP estimation. lnLAEI might be a useful echocardiographic parameter for noninvasive PCWP estimation.

14.
Eur Heart J ; 42(27): 2630-2642, 2021 07 15.
Artigo em Inglês | MEDLINE | ID: mdl-34059914

RESUMO

A substantial number of chronic coronary syndrome (CCS) patients undergoing percutaneous coronary intervention (PCI) experience periprocedural myocardial injury or infarction. Accurate diagnosis of these PCI-related complications is required to guide further management given that their occurrence may be associated with increased risk of major adverse cardiac events (MACE). Due to lack of scientific data, the cut-off thresholds of post-PCI cardiac troponin (cTn) elevation used for defining periprocedural myocardial injury and infarction, have been selected based on expert consensus opinions, and their prognostic relevance remains unclear. In this Consensus Document from the ESC Working Group on Cellular Biology of the Heart and European Association of Percutaneous Cardiovascular Interventions (EAPCI), we recommend, whenever possible, the measurement of baseline (pre-PCI) cTn and post-PCI cTn values in all CCS patients undergoing PCI. We confirm the prognostic relevance of the post-PCI cTn elevation >5× 99th percentile URL threshold used to define type 4a myocardial infarction (MI). In the absence of periprocedural angiographic flow-limiting complications or electrocardiogram (ECG) and imaging evidence of new myocardial ischaemia, we propose the same post-PCI cTn cut-off threshold (>5× 99th percentile URL) be used to define prognostically relevant 'major' periprocedural myocardial injury. As both type 4a MI and major periprocedural myocardial injury are strong independent predictors of all-cause mortality at 1 year post-PCI, they may be used as quality metrics and surrogate endpoints for clinical trials. Further research is needed to evaluate treatment strategies for reducing the risk of major periprocedural myocardial injury, type 4a MI, and MACE in CCS patients undergoing PCI.


Assuntos
Doença da Artéria Coronariana , Traumatismos Cardíacos , Infarto do Miocárdio , Intervenção Coronária Percutânea , Biomarcadores , Consenso , Humanos , Infarto do Miocárdio/etiologia , Intervenção Coronária Percutânea/efeitos adversos , Fatores de Risco , Resultado do Tratamento
15.
Catheter Cardiovasc Interv ; 98(4): E581-E585, 2021 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-34128584

RESUMO

Spontaneous coronary artery dissection (SCAD) can lead to acute coronary syndrome and sudden cardiac death, particularly in young women. Observational data show that, in SCAD patients, both percutaneous coronary intervention and coronary artery bypass grafting seem to be hampered by higher technical complexity, lower success rates, and worse outcomes. As spontaneous healing is a common occurrence, expert consensus advices medical management of the acute phase, when feasible. We present the case of a young woman with SCAD of left anterior descending artery causing myocardial infarction with ST-segment elevation. High-anatomical complexity and unstable conditions of the patient made both medical management and immediate revascularization unfeasible options. Therefore, we decided to implant a percutaneous off-loading mechanical support device to improve coronary perfusion pressure by unloading the left ventricle and preserve cardiac function, preventing worse complications of acute myocardial infarction. This strategy was successful in stabilizing the patient, until the definitive revascularization treatment became an option.

16.
Circ Cardiovasc Interv ; 14(7): e009827, 2021 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-34130478

RESUMO

The bicuspid aortic valve (BAV) represents a complex anatomic scenario for transcatheter aortic valve replacement (TAVR) because of its unique technical challenges. As TAVR is moving towards younger and lower-risk populations, the proportion of BAV patients undergoing TAVR is expected to rise. Initial experiences of TAVR with first-generation transcatheter heart valves in high surgical risk patients with BAV stenosis showed higher rates of device failure and periprocedural complications as compared to tricuspid anatomy. The subsequent advances in imaging techniques and understanding of BAV anatomy, new iterations of transcatheter heart valves, and growing operators' experience yielded better outcomes. However, in the lack of randomized trials and rigorous evidence, the field of TAVR in BAV has been driven by empirical observations, with wide variability in transcatheter heart valve sizing and implantation techniques across different centers and operators. Thus, in this review article, we provide a fully illustrated overview of operative periprocedural steps for TAVR in BAV stenosis, though recognizing that it still remains anecdotal.

18.
JAMA Cardiol ; 6(8): 936-944, 2021 Aug 01.
Artigo em Inglês | MEDLINE | ID: mdl-34009236

RESUMO

Importance: Transcatheter aortic valve replacement (TAVR) failure is often managed by an urgent implantation of a supplementary valve during the procedure (2-valve TAVR [2V-TAVR]). Little is known about the factors associated with or sequelae of 2V-TAVR. Objective: To examine the incidence, causes, and outcomes of 2V-TAVR. Design, Setting, and Participants: A retrospective cohort study was performed using data from an international registry of 21 298 TAVR procedures performed from January 1, 2014, through February 28, 2019. Among the 21 298 patients undergoing TAVR, 223 patients (1.0%) undergoing 2V-TAVR were identified. Patient-level data were available for all the patients undergoing 2V-TAVR and for 12 052 patients (56.6%) undergoing 1V-TAVR. After excluding patients with missing 30-day follow-up or data inconsistencies, 213 2V-TAVR and 10 010 1V-TAVR patients were studied. The 2V-TAVR patients were compared against control TAVR patients undergoing a 1-valve TAVR (1V-TAVR) using 1:4 17 propensity score matching. Final analysis included 1065 (213:852) patients. Exposures: Urgent implantation of a supplementary valve during TAVR. Main Outcomes and Measures: Mortality at 30 days and 1 year. Results: The 213 patients undergoing 2V-TAVR had similar age (mean [SD], 81.3 [0.5] years) and sex (110 [51.6%] female) as the 10 010 patients undergoing 1V-TAVR (mean [SD] age, 81.2 [0.5] years; 110 [51.6%] female). The 2V-TAVR incidence decreased from 2.9% in 2014 to 1.0% in 2018 and was similar between repositionable and nonrepositionable valves. Bicuspid aortic valve (odds ratio [OR], 2.20; 95% CI, 1.17-4.15; P = .02), aortic regurgitation of moderate or greater severity (OR, 2.02; 95% CI, 1.49-2.73; P < .001), atrial fibrillation (OR, 1.43; 95% CI, 1.07-1.93; P = .02), alternative access (OR, 2.59; 95% CI, 1.72-3.89; P < .001), early-generation valve (OR, 2.32; 95% CI, 1.69-3.19; P < .001), and self-expandable valve (OR, 1.69; 95% CI, 1.17-2.43; P = .004) were associated with higher 2V-TAVR risk. In 165 patients (80%), the supplementary valve was implanted because of residual aortic regurgitation after primary valve malposition (94 [46.4%] too high and 71 [34.2%] too low). In the matched 2V-TAVR vs 1V-TAVR cohorts, the rate of device success was 147 (70.4%) vs 783 (92.2%) (P < .001), the rate of coronary obstruction was 5 (2.3%) vs 3 (0.4%) (P = .10), stroke rate was 9 (4.6%) vs 13 (1.6%) (P = .09), major bleeding rates were 25 (11.8%) vs 46 (5.5%) (P = .03) and annular rupture rate was 7 (3.3%) vs 3 (0.4%) (P = .03). The hazard ratios for mortality were 2.58 (95% CI, 1.04-6.45; P = .04) at 30 days, 1.45 (95% CI, 0.84-2.51; P = .18) at 1 year, and 1.20 (95% CI, 0.77-1.88; P = .42) at 2 years. Nontransfemoral access and certain periprocedural complications were independently associated with higher risk of death 1 year after 2V-TAVR. Conclusions and Relevance: In this cohort study, valve malposition was the most common indication for 2V-TAVR. Incidence decreased over time and was low overall, although patients with a bicuspid or regurgitant aortic valve, nontransfemoral access, and early-generation or self-expandable valve were at higher risk. These findings suggest that compared with 1V-TAVR, 2V-TAVR is associated with high burden of complications and mortality at 30 days but not at 1 year.

19.
Artigo em Inglês | MEDLINE | ID: mdl-33961729

RESUMO

OBJECTIVES: To evaluate the use and outcomes of percutaneous mechanical circulatory support (pMCS) utilized during transcatheter aortic valve implantation (TAVI) from high-volume centers. METHODS AND RESULTS: Our international multicenter registry including 13 high-volume TAVI centers with 87 patients (76.5 ± 11.8 years, 63.2% men) who underwent TAVI for severe aortic stenosis and required pMCS (75.9% VA-ECMO, 19.5% Impella CP, 4.6% TandemHeart) during the procedure (prior to TAVI 39.1%, emergent rescue 50.6%, following TAVI 10.3%). The procedures were considered high-risk, with 50.6% having severe left ventricular dysfunction, 24.1% biventricular dysfunction, and 32.2% severe pulmonary hypertension. In-hospital and 1-year mortality were 27.5% and 49.4%, respectively. Patients with prophylactic hemodynamic support had lower periprocedural mortality compared to patients with rescue insertion of pMCS (log rank = 0.013) and patients who did not undergo cardiopulmonary resuscitation during the TAVI procedure had better short and long term survival (log rank <0.001 and 0.015, respectively). CONCLUSIONS: Given the overall survival rate and low frequency of pMCS-related complications, our study results support the use of pMCS prophylactically or during the course of TAVI (bailout) in order to improve clinical outcomes in high-risk procedures or in case of acute life-threatening hemodynamic collapse.

20.
JACC Cardiovasc Interv ; 14(11): 1181-1192, 2021 Jun 14.
Artigo em Inglês | MEDLINE | ID: mdl-33992550

RESUMO

OBJECTIVES: The purpose of this study was to examine the impact of residual mitral regurgitation (MR) on mortality in patients undergoing transcatheter aortic valve replacement (TAVR). BACKGROUND: MR is common in patients undergoing TAVR. Data on optimal management of patients with significant MR after TAVR are limited. METHODS: The registry consisted of 16 TAVR centers (n = 7,303). Outcomes of patients with ≥ moderate versus lesser grade MR after TAVR were compared. RESULTS: In 1,983 (27.2%) patients, baseline MR grade was ≥ moderate. MR regressed in 874 (44.1%) patients and persisted in 1,109 (55.9%) after TAVR. Four-year mortality was higher for those with MR persistence, but not for those with MR regression after TAVR, compared with nonsignificant baseline MR (43.8% vs. 35.1% vs. 32.4%; hazard ratio [HR]: 1.38; p = 0.008; HR: 1.02; p = 0.383, respectively). New York Heart Association functional class III to IV after TAVR was more common in those with MR persistence vs. regression (14.4% vs. 3.9%; p < 0.001). In a propensity score-matched cohort (91 patients' pairs), with significant residual MR after TAVR who did or did not undergo staged mitral intervention, staged intervention was associated with a better functional class through 1 year of follow-up (82.4% vs. 33.3% New York Heart Association functional class I or II; p < 0.001), and a numerically lower 4-year mortality, which was not statistically significant (64.6% vs. 37.5%; HR: 1.66; p = 0.097). CONCLUSIONS: Risk stratification based on improvement in MR and symptoms after TAVR can identify patients at increased mortality risk after TAVR. These patients may benefit from a staged transcatheter mitral intervention, but this requires further proof from future studies. (Transcatheter Treatment for Combined Aortic and Mitral Valve Disease. The Aortic+Mitral TRAnsCatheter [AMTRAC] Valve Registry [AMTRAC]; NCT04031274).

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