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2.
Open Heart ; 7(2)2020 10.
Artigo em Inglês | MEDLINE | ID: mdl-33122421

RESUMO

BACKGROUND: The role of planned angiographic control (PAC) over a conservative management driven by symptoms and ischaemia following percutaneous coronary intervention (PCI) of the unprotected left main (ULM) with second-generation drug-eluting stents remains controversial. PAC may timely detect intrastent restenosis, but it is still unclear if this translated into improved prognosis. METHODS AND ANALYSIS: PULSE is a prospective, multicentre, open-label, randomised controlled trial. Consecutive patients treated with PCI on ULM will be included, and after the index revascularisation patients will be randomised to PAC strategy performed with CT coronary after 6 months versus a conservative symptoms and ischaemia-driven follow-up management. Follow-up will be for at least 18 months from randomisation. Major adverse cardiovascular events at 18 months (a composite endpoint including death, cardiovascular death, myocardial infarction (MI) (excluding periprocedural MI), unstable angina, stent thrombosis) will be the primary efficacy outcome. Secondary outcomes will include any unplanned target lesion revascularisation (TLR) and TLR driven by PAC. Safety endpoints embrace worsening of renal failure and bleeding events. A sample size of 550 patients (275 per group) is required to have a 80% chance of detecting, as significant at the 5% level, a 7.5% relative reduction in the primary outcome. TRIAL REGISTRATION NUMBER: NCT04144881.

7.
N Engl J Med ; 383(1): 88-89, 2020 07 02.
Artigo em Inglês | MEDLINE | ID: mdl-32343497
8.
J Cardiovasc Electrophysiol ; 31(5): 1166-1174, 2020 May.
Artigo em Inglês | MEDLINE | ID: mdl-32141116

RESUMO

INTRODUCTION: Early evidence suggests that multipoint left ventricular pacing (MPP) may improve response to cardiac resynchronization therapy (CRT). It is unknown whether this benefit is sustained and cost-effective. We used real-world data to evaluate long-term impact of MPP-ON clinical status, heart failure hospitalizations (HFH) and costs. METHODS: The Italian registry on multipoint left ventricular pacing is a prospective, multicenter registry of patients implanted with MPP-enabled CRT devices. For this analysis, clinical and echocardiographic data were collected through 24 months and compared between patients with (MPP-ON) or without (MPP-OFF) early MPP activation at implant. The total cost of each HFH was estimated with national Italian reimbursement rates. RESULTS: The study included 190 MPP-OFF and 128 MPP-ON patients with similar baseline characteristics. At 1 and 2 years, the MPP-ON group had lower rates of HFH vs MPP-OFF (1-year hazard ratio [HR]: 0.14, P = .0014; 2-year HR: 0.38, P = .009). The finding persisted in a subgroup of patients with consistent MPP activation through follow-up (1-year HR: 0.19; P = .0061; 2-year HR: 0.39, P = .022). Total HFH per-patient costs were lower in the MPP-ON vs the MPP-OFF group at 1 year (€101 ± 50 vs €698 ± 195, P < .001) and 2 years (€366 ± 149 vs €801 ± 203, P = .038). More MPP-ON patients had ≥5% improvement in ejection fraction (76.8% vs 65.4%, P = .025) and clinical composite score (66.7% vs 47.5%, P = .01). CONCLUSIONS: In this multicenter clinical study, early MPP activation was associated with a significant reduction in cumulative HFH and related costs after 1 and 2 years of follow-up.

9.
Circ Cardiovasc Interv ; 13(3): e008325, 2020 03.
Artigo em Inglês | MEDLINE | ID: mdl-32102566

RESUMO

BACKGROUND: There are limited data regarding the impact of final kissing balloon (FKI) in patients treated with percutaneous coronary intervention using ultrathin stents in left main or bifurcations. METHODS: All patients undergoing left main or bifurcations percutaneous coronary intervention enrolled in the RAIN registry (Very Thin Stents for Patients With MAIN or BiF in Real Life: The RAIN, a Multicenter Study) evaluating ultrathin stents were included. Major adverse cardiac event (a composite of all-cause death, myocardial infarction, target lesion revascularization, and stent thrombosis) was the primary end point, while its components, along with target vessel revascularization, were the secondary end points. The main analysis was performed comparing patients with and without FKI after adjustment with inverse probability of treatment weighting. Subgroup analyses were performed according to FKI (short [<3 mm] versus long overlap), strategy (provisional versus 2-stent), routine versus bail-out FKI, and the use of imaging and proximal optimization technique. RESULTS: Two thousand seven hundred forty-two patients were included. At 16 months (8-20) follow-up, inverse probability of treatment weighting adjusted rates of major adverse cardiac event were similar between FKI and no-FKI group (15.1% versus 15.5%; P=0.967), this result did not change with use of imaging, proximal optimization technique, or routine versus bail-out FKI. In the 2-stent subgroup, FKI was associated with lower rates of target vessel revascularization (7.8% versus 15.9%; P=0.030) and target lesion revascularization (7.3% versus 15.2%; P=0.032). Short overlap FKI was associated with a lower rate of target lesion revascularization compared with no FKI (2.6% versus 5.4%; P=0.034), while long overlap was not (6.8% versus 5.4%; P=0.567). CONCLUSIONS: In patients with bifurcations or unprotected left main treated with ultrathin stents, short overlap FKI is associated with less restenosis. In a 2-stent strategy, FKI was associated with less target vessel revascularization and restenosis. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03544294.


Assuntos
Angioplastia Coronária com Balão/instrumentação , Doença da Artéria Coronariana/terapia , Desenho de Prótese , Stents , Idoso , Idoso de 80 Anos ou mais , Angioplastia Coronária com Balão/mortalidade , Doença da Artéria Coronariana/mortalidade , Reestenose Coronária/etiologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Sistema de Registros , Estudos Retrospectivos , Fatores de Risco , Resultado do Tratamento
10.
Catheter Cardiovasc Interv ; 95(3): 522-529, 2020 Feb 15.
Artigo em Inglês | MEDLINE | ID: mdl-31385427

RESUMO

OBJECTIVES: Evaluate safety and efficacy of polymer-free biolimus-eluting stents (PF-BESs) versus ultrathin stents in unprotected left main (ULM) or bifurcation. BACKGROUND: PF-BESs due to reduced length of dual antiplatelet therapy (DAPT) are increasingly used. However, there are limited data about safety and efficacy for ULM or bifurcation. METHODS: We selected all-patients treated for ULM or bifurcation from two multicenter real life registries (RAIN [NCT03544294] evaluating ultrathin stents, CHANCE [NCT03622203] appraising PF-BES). After propensity score with matching, the primary endpoint was major adverse cardiac events (MACE; a composite of all-cause death, myocardial infarction, target lesion revascularization [TLR], and stent thrombosis [ST]), while its components along with target vessel revascularization (TVR) secondary endpoints. RESULTS: Three thousand and three patients treated with ultrathin stents and 446 with PF-BESs, resulting respectively in 562 and 281 after propensity score with matching (33 and 22%, respectively, with ULM disease). After 12 (8-20) months, rates of MACE were similar (9 vs. 8%, p = 0.56) without difference in TLR and ST (3.0 vs. 1.7%, p = .19 and 1.8 vs. 1.1%, p = .42). These results were consistent for ULM group (3 vs. 1.7% and 1.8 vs. 1.1%, p = .49 and .76), for non-ULM group (2.1 vs. 3.4%, p = .56 and 1.2 vs. 1.7%, p = .78) and for two-stent strategy (8.7 vs. 4.5% and 4.3 vs. 3.2%, p = .75 and .91). Among patients treated with 1 month of DAPT in both groups, those with ultrathin stents experienced higher rates of MACE related to all-cause death (22 vs. 12%, p = .04) with higher although not significant rates of ST (3 vs. 0%, p = .45). CONCLUSIONS: PF-BES implanted on ULM or BiF offered freedom from TLR and ST comparable to ultrathin stents. PF-BESs patients assuming DAPT for 1 month experienced a lower despite not significant incidence of ST.

11.
JACC Clin Electrophysiol ; 5(10): 1197-1208, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31648745

RESUMO

OBJECTIVES: This study evaluated the temporal association between atrial high-rate episodes (AHREs) and sustained ventricular arrhythmias (VAs) in a remotely monitored cohort with implantable cardioverter-defibrillators (ICD) with and/or without cardiac resynchronization therapy with a defibrillator (CRT-D). BACKGROUND: Clinical relevance of AHREs in terms of VA rate and survival has not been outlined yet. METHODS: This study analyzed data of patients with ICDs and CRT-Ds from the nationwide Home Monitoring Expert Alliance network. The cohort included 2,435 patients with a median follow-up of 25 months (interquartile range: 13 to 42 months) and age 70 years (range 61 to 77 years); 19.7% were women, 51.4% had coronary artery disease, and 45.2% had a CRT-D. There were 3,410 appropriate VA episodes; 498 (14.6%) were preceded by AHREs within 48 h; in 85.5% of this group, AHREs were still ongoing at episode onset. RESULTS: In a longitudinal analysis, the odds ratios (ORs) of experiencing any VA in a 30-day interval with AHREs versus intervals without AHREs were 2.35 (95% confidence interval [CI]: 1.86 to 2.97; p < 0.001) for ventricular tachycardia (VT), 3.06 (95% CI: 2.35 to 3.99; p < 0.001) for fast VT, 1.84 (95% CI: 1.36 to 2.48; p < 0.001) for self-extinguishing ventricular fibrillation (VF), and 2.31 (95% CI: 1.17 to 4.57; p = 0.01) for VF. ORs decreased with increasing AHRE burden. Patients with AHREs 48 h before VAs were more likely to experience VA recurrences (adjusted hazard ratio [HR]: 1.78; 95% CI: 1.41 to 2.24; p < 0.001) and had higher overall mortality (HR: 2.67; 95% CI: 1.68 to 4.23; p < 0.001). CONCLUSIONS: AHREs were not uncommon 48 h before VAs, which tended to be distributed around intervals with AHREs. Temporal connection between AHREs and VAs was a marker of increased risk of VA recurrence and a poorer prognosis.

12.
J Cardiovasc Electrophysiol ; 30(12): 2885-2891, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31661172

RESUMO

BACKGROUND: Multipoint pacing (MPP) may improve clinical outcomes in patients with cardiac resynchronization therapy defibrillators (CRT-D), but its impact on battery longevity in a real-world population has not been investigated in large trials. OBJECTIVE: Compare projected battery longevity in CRT-D patients with and without MPP during long-term follow-up. METHODS: The Italian registry on multipoint left ventricular pacing (IRON-MPP) is a prospective, multicenter registry of patients implanted with MPP-capable CRT-D devices. Projected battery longevity during follow-up was compared for patients with MPP (MPP ON) vs single-site (MPP OFF) left ventricular pacing at CRT-D implantation. A sub-analysis excluded crossover patients with MPP activation or deactivation occurring after implantation. A second sub-analysis excluded patients with a right or left ventricular pacing amplitude >2.5 V. RESULTS: Out of 237 CRT-D patients (71 ± 9 years, 81% male) followed for 1.9 ± 0.8 years, 102 (43%) had MPP ON at implantation. Programmed atrial and ventricular outputs and percentage of pacing were similar between groups. MPP was associated with a 0.44 years reduction in projected battery longevity (P = .03) during long-term follow-up. Results were similar for the first and second sub-analyses, with a 0.57 years (P < .001) and 0.71 years (P < .001) reduction in projected longevity, respectively. CONCLUSION: In this long-term real-world registry, early MPP activation is associated with less than a 1-year reduction in projected battery life compared to single-site biventricular pacing.

13.
G Ital Cardiol (Rome) ; 20(2): 117-119, 2019 Feb.
Artigo em Italiano | MEDLINE | ID: mdl-30747927

RESUMO

The majority of myxomas are located in the left atrium (75%) followed by the right atrium (20%). In rare cases, myxomas can be found in the ventricles, with 2.5% reported for myxomas in the left ventricle. Systemic emboli, mostly cerebral, occur in two thirds of such patients, while coronary emboli are rare. Here we report a case of left ventricular myxoma causing infero-postero-lateral myocardial infarction, successfully treated by intracoronary thromboaspiration of myxoma embolus.


Assuntos
Embolia/diagnóstico , Neoplasias Cardíacas/complicações , Infarto do Miocárdio/etiologia , Mixoma/complicações , Adulto , Embolia/complicações , Feminino , Neoplasias Cardíacas/diagnóstico , Ventrículos do Coração/patologia , Humanos , Mixoma/diagnóstico
14.
Int J Cardiol ; 280: 74-79, 2019 04 01.
Artigo em Inglês | MEDLINE | ID: mdl-30661851

RESUMO

BACKGROUND: Despite expanding indication of the subcutaneous implantable cardioverter defibrillator (S-ICD) in clinical practice, limited data exists on safety and efficacy of S-ICD in arrhythmogenic right ventricular cardiomyopathy (ARVC) patients. The aim of this multicenter study was to evaluate the safety and efficacy of S-ICD in ARVC patients. METHODS: The study population included 44 consecutive patients with definite ARVC diagnosis according to the 2010 ITF criteria (57% male, mean age 37 ±â€¯17 years [range 10-75 years]) who received an S-ICD. Eighteen (41%) patients were implanted for secondary prevention. RESULTS: At implant, all inducible patients (34/44) had conversion of ventricular fibrillation at 65 J. No early complications occurred. During a median follow-up of 12 months (7-19), 3 (6.8%) patients experienced complications requiring surgical revision. No local or systemic device-related infections were observed. Six patients (14%) received a total of 61 appropriate and successful shocks on ventricular arrhythmias. Six (14%) patients experienced 8 inappropriate shocks for oversensing of cardiac signal (4 cases) and non-cardiac signal (4 cases) with one patient requiring device explantation. No patients had the device explanted due to the need for antitachycardia pacing. CONCLUSIONS: The study shows that S-ICD provides safe and effective therapy for termination of both induced and spontaneous malignant ventricular tachyarrhythmias with high energy shocks in ARVC patients, but the risk of inappropriate shocks and complications needing surgical revision should be considered.


Assuntos
Displasia Arritmogênica Ventricular Direita/fisiopatologia , Displasia Arritmogênica Ventricular Direita/terapia , Desfibriladores Implantáveis , Sistema de Registros , Tela Subcutânea , Adolescente , Adulto , Idoso , Displasia Arritmogênica Ventricular Direita/diagnóstico , Criança , Desfibriladores Implantáveis/tendências , Eletrocardiografia/métodos , Eletrocardiografia/tendências , Feminino , Seguimentos , Humanos , Itália/epidemiologia , Masculino , Pessoa de Meia-Idade , Adulto Jovem
15.
Europace ; 21(3): 502-510, 2019 Mar 01.
Artigo em Inglês | MEDLINE | ID: mdl-30508076

RESUMO

AIMS: Anatomical placement of the coronary sinus (CS) lead in basal or mid-ventricular positions of the posterior and lateral walls is associated with a better clinical outcome of cardiac resynchronization therapy (CRT). We hypothesized that optimization of CS lead placement targeted the right-to-left electrical delay (RLD) predicts an additional clinical benefit. METHODS AND RESULTS: The CS lead was placed according to current standards in 90 patients (Conventional group) and at the site of the longest RLD in 121 patients (RLD group). Non-responders were defined as those who died or underwent hospitalization for heart failure or did not improve in their Clinical Composite Score within 6 months. There were 67 (32%) non-responders. Compared with Conventional group, the final CS pacing site was more frequently in the basal segments in the RLD group (40% vs. 23%, P = 0.007); moreover, the RLD ratio (%RLD) of the total QRS width was longer (77 ± 13 vs. 73 ± 15, P = 0.05) and biventricular QRS shortened more from the baseline (-31 ± 21 ms vs. -21 ± 26 ms, P = 0.004). Nevertheless, the rate of non-responders was similar in the RLD and Conventional groups (35% vs. 28%, P = 0.30), as was %RLD (76 ± 16 vs. 75 ± 13, P = 0.66). QRS width during right ventricular (RV) pacing was an independent predictors of adverse outcome, with a 2% increase in the risk of failure for each 1 ms increase in QRS (P = 0.006). CONCLUSION: Optimization of CS lead placement targeted to latest electrical activation does not provide additional clinical benefit to anatomical placement in basal or mid-ventricular positions of the posterior and lateral walls. QRS width during RV pacing was a strong predictor of CRT failure. CLINICAL TRIAL REGISTRATION: http://www.clinicaltrials.gov. Unique identifier: NCT03204864.

16.
J Interv Card Electrophysiol ; 54(1): 49-54, 2019 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-30187250

RESUMO

BACKGROUND: Before subcutaneous implantable cardioverter defibrillator (S-ICD) implantation, the adequacy of sensing is required to be verified through surface ECG screening. Our objective was to determine whether S-ICD can be considered as a supplementary therapy in patients who are receiving biventricular (BIV) pacing. METHODS: We evaluated 48 patients with BIV devices to determine S-ICD candidacy during BIV, left ventricular (LV), right ventricular (RV) pacing, and intrinsic conduction (left bundle branch block-LBBB) by using an automated screening tool. Eligibility was defined by the presence of at least one appropriate vector in the supine and standing positions. RESULTS: Eligibility was verified during BIV pacing in 34 (71%) patients. In patients screened-out, QRS duration was longer (p = 0.035) and ischemic cardiomyopathy was more frequent (p = 0.027). LV-only pacing was associated with a lower passing rate (46%) (p < 0.001 versus BIV). The LBBB QRS morphology during inhibited ventricular pacing was acceptable in 51% of patients. The QRS generated by RV pacing was acceptable in 25% of patients. In patients who passed the screening test during BIV, the QRS was not acceptable in 76% during RV pacing (i.e., accidental loss of LV capture). The concomitant adequacy during inhibited ventricular pacing (i.e., possible intrinsic conduction) was not assessed in 40% of patients. CONCLUSIONS: S-ICD may be a supplemental therapy in the majority of CRT patients. Standard BIV pacing should be preferred to the LV-only pacing mode, as it is more frequently associated with adequacy of S-ICD sensing. Spontaneous LBBB and RV-paced QRS morphologies are frequently inadequate. Therefore, in patients selected for concomitant S-ICD and CRT implantation, accidental loss of LV capture or possible intrinsic conduction must be prevented.


Assuntos
Mapeamento Potencial de Superfície Corporal/métodos , Bloqueio de Ramo/terapia , Estimulação Cardíaca Artificial/métodos , Desfibriladores Implantáveis , Insuficiência Cardíaca/terapia , Bloqueio de Ramo/diagnóstico por imagem , Bloqueio de Ramo/mortalidade , Terapia de Ressincronização Cardíaca/métodos , Distribuição de Qui-Quadrado , Estudos de Coortes , Feminino , Insuficiência Cardíaca/diagnóstico por imagem , Insuficiência Cardíaca/mortalidade , Humanos , Itália , Masculino , Seleção de Pacientes , Prognóstico , Medição de Risco , Índice de Gravidade de Doença , Estatísticas não Paramétricas , Taxa de Sobrevida , Resultado do Tratamento
17.
J Interv Card Electrophysiol ; 53(3): 373-381, 2018 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-30276592

RESUMO

BACKGROUND: Remote monitoring (RM) of implantable cardioverter defibrillators (ICD) has been shown to improve patient safety and reduce in-office visits. The subcutaneous ICD (S-ICD) is an effective alternative to transvenous ICD and has recently been endowed with the RM function. However, the RM communicator for S-ICD requires patient interaction to activate data transmission. We assessed patient compliance and acceptance. METHODS: Patients with S-ICD received the communicator and were followed up for 15 months. Weekly remote transmissions were programmed. Compliance with checks was measured as the number of checks performed by the patient divided by the number of automatic notifications by the communicator. A questionnaire on acceptance of the system was administered to patients. RESULTS: A total of 106 patients were analyzed. The proportion of weekly checks properly executed by the patients was 94% during the first 3 months and 93% from months 12 to 15. Of the checks performed, 93% were on the same day as the automatic notification. On a patient basis, compliance with weekly checks was > 85% (less than one check missed per month) in 88% of patients during the first 3 months and in 82% from months 12 to 15 (p = 0.615). No variables emerged as predictors of lower (≤ 85%) long-term compliance with weekly checks. During follow-up, 49 alerts were transmitted and the mean delay between the detected event and the patient transmission was 2 ± 2 days. The majority of patients found the system easy to use and felt confident about being remotely monitored. CONCLUSIONS: The level of patient compliance with remote checks is high with current technology for RM of S-ICD. The vast majority of data transmissions are consistently performed on a weekly basis on the day scheduled.


Assuntos
Desfibriladores Implantáveis , Monitorização Fisiológica , Aceitação pelo Paciente de Cuidados de Saúde/estatística & dados numéricos , Cooperação do Paciente/estatística & dados numéricos , Tecnologia de Sensoriamento Remoto/métodos , Taquicardia Ventricular/prevenção & controle , Atitude Frente a Saúde , Desfibriladores Implantáveis/psicologia , Desfibriladores Implantáveis/estatística & dados numéricos , Feminino , Humanos , Itália/epidemiologia , Masculino , Pessoa de Meia-Idade , Monitorização Fisiológica/métodos , Monitorização Fisiológica/psicologia , Monitorização Fisiológica/estatística & dados numéricos , Participação do Paciente/métodos , Participação do Paciente/estatística & dados numéricos , Implantação de Prótese/métodos , Taquicardia Ventricular/epidemiologia
18.
Int J Cardiol ; 272: 162-167, 2018 Dec 01.
Artigo em Inglês | MEDLINE | ID: mdl-30087041

RESUMO

BACKGROUND: The subcutaneous implantable cardioverter defibrillator (S-ICD) is a relatively novel alternative to the transvenous ICD for the treatment of life-threatening ventricular arrhythmias, and is currently used in the clinical practice of several centers. The aim of this analysis was to describe current Italian practice regarding S-ICD implantation and its evolution over the years. METHODS: We analyzed 607 consecutive patients (78% male, 48 ±â€¯16 years) who underwent S-ICD implantation in 39 Italian centers from 2013 to 2017. RESULTS: Structural cardiomyopathy was present in 78% of patients and 30% of patients received their device for secondary prevention. The proportion of patients with dilated cardiomyopathy and with left ventricular ejection fraction ≤35% increased from ≤2014 to 2017 (from 38% to 58%, from 33% to 53%, respectively; both p < 0.05). Almost all procedures (97%) were performed in electrophysiology laboratories. Over the last 4 years, the 2-incision implantation technique has been widely adopted, with sub- or inter-muscular positioning of the generator, under local anesthesia or deep sedation (≤2014 versus 2017: all p < 0.001). Defibrillation testing was performed in 81% of patients. Shock energy of ≤65 J was successful in 93.9% of patients and the overall cardioversion success rate at ≤80 J was 99.8%. CONCLUSIONS: Our analysis confirmed that the S-ICD continues to be preferentially used in specific patients (younger, less frequently with dilated cardiomyopathy and low ejection fraction.). Nonetheless, we noted a trend toward the wider use of S-ICD in patients with dilated cardiomyopathy and systolic dysfunction over the years. Novel approaches have been adopted while the acute efficacy of the system has remained stably high.


Assuntos
Arritmias Cardíacas/epidemiologia , Arritmias Cardíacas/prevenção & controle , Desfibriladores Implantáveis/tendências , Tela Subcutânea , Adulto , Arritmias Cardíacas/fisiopatologia , Desfibriladores Implantáveis/normas , Eletrocardiografia/normas , Eletrocardiografia/tendências , Feminino , Humanos , Itália/epidemiologia , Masculino , Pessoa de Meia-Idade , Sistema de Registros , Tela Subcutânea/cirurgia , Resultado do Tratamento
19.
Biomed Res Int ; 2018: 1404659, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-29951525

RESUMO

Objective: The aim of the study was to compare the two approaches to chronic right ventricular pacing currently adopted in clinical practice: right ventricular apical (RVA) and non-RVA pacing. Background: Chronic RVA pacing is associated with an increased risk of atrial fibrillation, morbidity, and even mortality. Non-RVA pacing may yield more physiologic ventricular activation and provide potential long-term benefits and has recently been adopted as standard procedure at many implanting centers. Methods: The Right Pace study was a multicenter, prospective, single-blind, nonrandomized trial involving 437 patients indicated for dual-chamber pacemaker implantation with a high percentage of RV pacing. Results: RV lead-tip target location was the apex or the interventricular septum. RVA (274) and non-RVA patients (163) did not differ in baseline characteristics. During a median follow-up of 19 months (25th-75th percentiles, 13-25), 17 patients died. The rates of the primary outcome of death due to any cause or hospitalization for heart failure were comparable between the groups (log-rank test, p = 0.609), as were the rates of the composite of death due to any cause, hospitalization for heart failure, or an increase in left ventricular end-systolic volume ≥ 15% as compared with the baseline evaluation (secondary outcome, p = 0.703). After central adjudication of X-rays, comparison between adjudicated RVA (239 patients) and non-RVA (170 patients) confirmed the absence of difference in the rates of primary (p = 0.402) and secondary (p = 0.941) outcome. Conclusions: In patients with indications for dual-chamber pacemaker who require a high percentage of ventricular stimulation, RVA or non-RVA pacing resulted in comparable outcomes. This study is registered with ClinicalTrials.gov (identifier: NCT01647490).


Assuntos
Bloqueio Atrioventricular , Estimulação Cardíaca Artificial , Idoso , Idoso de 80 Anos ou mais , Feminino , Ventrículos do Coração , Humanos , Masculino , Estudos Prospectivos , Qualidade de Vida , Reprodutibilidade dos Testes , Método Simples-Cego , Resultado do Tratamento
20.
Int J Cardiol ; 257: 1-6, 2018 04 15.
Artigo em Inglês | MEDLINE | ID: mdl-29506674

RESUMO

BACKGROUND: The potential protective effects of remote ischemic preconditioning (RIPC) on contrast-induced nephropathy (CIN) after percutaneous coronary intervention (PCI) remain to be defined. METHODS AND RESULTS: A double blind, randomized, placebo controlled multicenter study was performed. Patients younger than 85years old, with a renal clearance of 30-60ml/min/1.73m2, who were candidates for PCI for all clinical indications except for primary PCI, were allocated 1:1 to RIPC or to standard therapy. The primary endpoint was incidence of CIN. The secondary endpoint was incidence of peri-procedural myocardial infarction (PMI). From February 2013 to April 2014, 3108 patients who were scheduled for coronary angiography were screened for the study. 442 fulfilled the inclusion criteria and 223 received PCI. These patients were randomized to sham RIPC (n=107) or treatment group (n=116). The only pre-specified subgroup of diabetic patients included 85 (38%) cases. RIPC significantly reduced CIN incidence in the overall population (12.1% vs. 26.1%, p=0.01, with a NNT=9) and in non-diabetic patients (9.2% vs. 25.0%, p=0.02), but showed no benefit in diabetics (16.7% vs. 28.2%, p=0.21). A trend for lower PMI was seen in the intervention arm (creatine kinase - muscle brain >5 URL; 8.4% vs. 16.4%, p=0.07; troponin T >5 URL; 27% vs. 38%, p=0.21). CONCLUSIONS: Remote ischemic preconditioning significantly reduces the incidence of acute kidney injury in non-diabetic patients undergoing PCI. Larger sample size is presumably needed to assess the effect of RIPC for patients with diabetes mellitus. Clinical Trial number:NCT02195726https://www.clinicaltrial.gov/.


Assuntos
Lesão Renal Aguda/diagnóstico por imagem , Lesão Renal Aguda/prevenção & controle , Meios de Contraste/efeitos adversos , Precondicionamento Isquêmico/tendências , Intervenção Coronária Percutânea/tendências , Lesão Renal Aguda/induzido quimicamente , Idoso , Idoso de 80 Anos ou mais , China/epidemiologia , Método Duplo-Cego , Europa (Continente)/epidemiologia , Feminino , Humanos , Precondicionamento Isquêmico/métodos , Precondicionamento Isquêmico Miocárdico/métodos , Precondicionamento Isquêmico Miocárdico/tendências , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos
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