Adverse Events of Percutaneous Microaxial Left Ventricular Assist Devices-A Retrospective, Single-Centre Cohort Study.
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SUBMITTER: Zaiser AS
PROVIDER: S-EPMC8396891 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Data on relative safety, efficacy, and role of different percutaneous left ventricular assist devices for hemodynamic support during the ventricular tachycardia (VT) ablation procedure are limited.We performed a multicenter, observational study from a prospective registry including all consecutive patients (N=66) undergoing VT ablation with a percutaneous left ventricular assist devices in 6 centers in the United States. Patients with intra-aortic balloon pump (IABP group; N=22) were compared with patients with either an Impella or a TandemHeart device (non-IABP group; N=44). There were no significant differences in the baseline characteristics between both the groups. In non-IABP group (1) more patients could undergo entrainment/activation mapping (82% versus 59%; P=0.046), (2) more number of unstable VTs could be mapped and ablated per patient (1.05±0.78 versus 0.32±0.48; P<0.001), (3) more number of VTs could be terminated by ablation (1.59±1.0 versus 0.91±0.81; P=0.007), and (4) fewer VTs were terminated with rescue shocks (1.9±2.2 versus 3.0±1.5; P=0.049) when compared with IABP group. Complications of the procedure trended to be more in the non-IABP group when compared with those in the IABP group (32% versus 14%; P=0.143). Intermediate term outcomes (mortality and VT recurrence) during 12±5-month follow-up were not different between both groups. Left ventricular ejection fraction ?15% was a strong and independent predictor of in-hospital mortality (53% versus 4%; P<0.001).Impella and TandemHeart use in VT ablation facilitates extensive activation mapping of several unstable VTs and requires fewer rescue shocks during the procedure when compared with using IABP.
| S-EPMC4329420 | biostudies-literature
Project description:ImportanceInformation regarding the performance and outcomes of noncardiac surgery (NCS) in patients with left ventricular assist devices (LVADs) is scarce, with limited longitudinal follow-up data that are mostly limited to single-center reports.ObjectiveTo examine the trends, patient characteristics, and outcomes associated with NCS among patients with LVAD.Design, setting, and participantsThis cohort study examined patients enrolled in Medicare undergoing durable LVAD implantation from January 2012 to November 2017 with follow-up through December 2017. The study included all Medicare Provider and Analysis Review Part A files for the years 2012 to 2017. Patients identified by International Classification of Diseases, Ninth Revision Clinical Modification (ICD-9-CM) and International Classification of Diseases, Tenth Revision (ICD-10) procedure codes for new LVAD implantation were included. Data analysis was performed from November 2019 to February 2020.ExposuresNCS procedures were identified using the ICD-9-CM and ICD-10 procedural codes and divided into elective and urgent or emergent.Main outcomes and measuresThe primary outcome was major adverse cardiovascular events (MACEs), defined as in-hospital or 30-day all-cause mortality, ischemic stroke, or intracerebral hemorrhage after NCS. Early (<60 days after NCS) and late (≥60 days after NCS) mortality after NCS were analyzed in both subgroups using time-varying covariate and landmark analysis using patients who did not undergo NCS as reference.ResultsOf the 8118 patients with LVAD (mean [SD] age, 63.4 [10.8] years; 6484 men [79.9%]), 1326 (16.3%, or approximately 1 in 6) underwent NCS, of which 1000 procedures (75.4%) were emergent or urgent and 326 (24.6%) were elective. There was no difference in age between patients who underwent NCS and patients who did not (mean [SD] age, 63.6 [10.6] vs 63.4 [10.9] years). The number of NCS procedures among patients with LVAD increased from 64 in 2012 to 304 in 2017. The median (interquartile range) time from LVAD implantation to NCS was 309 (133-606) days. The most frequent type of NCS was general (613 abdominal, pelvic, and gastrointestinal procedures [46.2%]). Perioperative MACEs occurred in 169 patients (16.9%) undergoing emergent or urgent NCS and 23 patients (7.1%) undergoing elective NCS. Urgent or emergent NCS was associated with higher mortality early (adjusted hazard ratio [aHR], 8.78; 95% CI, 7.20-10.72; P < .001) and late (aHR, 1.71; 95% CI, 1.53-1.90; P < .001) after NCS compared with patients with LVAD who did not undergo NCS. Elective NCS was also associated with higher mortality early (aHR, 2.65; 95% CI, 1.74-4.03; P < .001) and late (aHR, 1.29; 95% CI, 1.07-1.56; P = .008) after NCS.Conclusions and relevanceOne of 6 patients with LVAD underwent NCS. Perioperative MACEs were frequent. Higher mortality risk transcended the early postoperative period in urgent or emergent and elective surgical procedures.
| S-EPMC7662145 | biostudies-literature
Project description:This review provides a comprehensive overview of the past 25+ years of research into the development of left ventricular assist device (LVAD) to improve clinical outcomes in patients with severe end-stage heart failure and basic insights gained into the biology of heart failure gleaned from studies of hearts and myocardium of patients undergoing LVAD support. Clinical aspects of contemporary LVAD therapy, including evolving device technology, overall mortality, and complications, are reviewed. We explain the hemodynamic effects of LVAD support and how these lead to ventricular unloading. This includes a detailed review of the structural, cellular, and molecular aspects of LVAD-associated reverse remodeling. Synergisms between LVAD support and medical therapies for heart failure related to reverse remodeling, remission, and recovery are discussed within the context of both clinical outcomes and fundamental effects on myocardial biology. The incidence, clinical implications and factors most likely to be associated with improved ventricular function and remission of the heart failure are reviewed. Finally, we discuss recognized impediments to achieving myocardial recovery in the vast majority of LVAD-supported hearts and their implications for future research aimed at improving the overall rates of recovery.
| S-EPMC9132540 | biostudies-literature
Project description:BackgroundPercutaneous ventricular assist devices (PVADs) have been replacing intra-aortic balloon pumps for hemodynamic support during percutaneous coronary intervention (PCI), even though data supporting a benefit for hard clinical end points remain limited. We evaluated diffusion of PVADs across US markets and examined the association of market utilization of PVAD with mortality and cost.MethodsUsing the 2013 to 2019 Medicare data, we identified all patients aged ≥65 years who underwent PCI with either a PVAD or intra-aortic balloon pump. We used hospital referral region to define regional health care markets and categorized them in quartiles based on the proportional use of PVADs during PCI. Multilevel models were constructed to determine the association of patient, hospital, and market factors with utilization of PVADs and the association of PVAD utilization with 30-day mortality and cost.ResultsA total of 79 176 patients underwent PCI with either intra-aortic balloon pump (47 514 [60.0%]) or PVAD (31 662 [40.0%]). The proportion of PCI procedures with PVAD increased over time (17% in 2013 to 57% in 2019; P for trend, <0.001), such that PVADs overtook intra-aortic balloon pump for hemodynamic support during PCI in 2018. There was a large variation in PVAD utilization across markets (range, 0%-85%), which remained unchanged after adjustment of patient characteristics (median odds ratio, 2.05 [95% CI, 1.91-2.17]). The presence of acute myocardial infarction, cardiogenic shock, and emergent status was associated with a 45% to 50% lower odds of PVAD use suggesting that PVADs were less likely to be used in the sickest patients. Greater utilization of PVAD at the market level was not associated with lower risk mortality but was associated with higher cost.ConclusionsAlthough utilization of PVADs for PCI continues to increase, there is large variation in PVAD utilization across markets. Greater market utilization of PVADs was not associated with lower mortality but was associated with higher cost.
| S-EPMC10797917 | biostudies-literature
Project description:AimsOutflow graft obstruction is a poorly described complication following left ventricular assist device (LVAD) surgery. We sought to define the incidence of LVAD outflow graft obstruction and assess clinical outcomes with a percutaneous treatment strategy.Methods and resultsFrom January 2012 to October 2020, 322 patients with LVAD were managed at our institution. Patients with LVAD outflow graft obstruction were identified by cardiac computed tomography with angiography and invasive haemodynamic assessment and were subsequently treated with percutaneous intervention. Poisson regression was used to analyse time-dependent differences in the incidence of LVAD outflow graft obstruction. Kaplan-Meier analysis was used to estimate survival. Twenty patients (6.2%) developed haemodynamically significant LVAD outflow graft obstruction at a rate of 0.03 events per patient-year. Outflow graft obstruction presented a median of 33 (26-49) months after surgery. Patients presented with low estimated LVAD pump flow (95%), heart failure (90%), or both (85%), and 59% developed cardiogenic shock prior to intervention. The most common aetiology identified by cardiac computed tomography with angiography was external compression of the outflow graft (78%). On presentation, the median peak gradient in the outflow graft was 78 (64-100) mmHg. Outflow graft stenting was 100% successful with no in-hospital mortality, and it reduced the peak outflow graft gradient to 10 (2-17) mmHg (P < 0.001). Outflow graft stenting was durable with two patients (10%) requiring a repeat procedure over a median follow-up of 13 (7-20) months and did not impact survival.ConclusionsLeft ventricular assist device outflow graft obstruction is a relatively common and underappreciated cause of recurrent heart failure and LVAD dysfunction. Outflow graft stenting can be achieved with low morbidity and provides a long-term solution to this complication.
| S-EPMC8120379 | biostudies-literature
Project description:The left ventricular assist device (LVAD) is often used in the treatment of heart failure. However, 4% to 9% implanted LVAD will have thrombosis problem in one year, which is fatal to the patient's life. In this work, an interventional sonothrombolysis (IST) method is developed to realize the thrombolysis on LVAD. A pair of ultrasound transducer rings is installed on the shell of LVAD, and drug-loaded microbubbles are injected into the LVAD through the interventional method. The microbubbles are adhere on the thrombus with the coated thrombus-targeted drugs, and the thrombolytic drugs carried by the bubbles are brought into the thrombus by the cavitation of bubbles under the ultrasound. In a proof-of-concept experiment in a live sheep model, the thrombus on LVAD is dissolved in 30 min, without damages on LVADs and organs. This IST exhibits to be more efficient and safer compared with other thrombolysis methods on LVAD.
| S-EPMC9313509 | biostudies-literature
Project description:BackgroundThere are limited data on the complications with a percutaneous left ventricular assist device (pLVAD) vs. intra-aortic balloon pump (IABP) in acute myocardial infarction-cardiogenic shock (AMI-CS).ObjectiveTo assess the trends, rates and predictors of complications.MethodsUsing a 17-year AMI-CS population from the National Inpatient Sample, AMI-CS admissions receiving pLVAD and IABP support were evaluated for vascular, lower limb amputation, hematologic, neurologic and acute kidney injury (AKI) complications. In-hospital mortality, hospitalization costs and length of stay in pLVAD and IABP cohorts with complications was studied.ResultsOf 168,645 admissions, 7,855 (4.7%) receiving pLVAD support. The pLVAD cohort had higher comorbidity, cardiac arrest (36.1% vs. 29.7%) and non-cardiac organ failure (74.7% vs. 56.9%) rates. Complications were higher in pLVAD compared to IABP cohort-overall 69.0% vs. 54.7%; vascular 3.8% vs. 2.1%; lower limb amputation 0.3% vs. 0.3%; hematologic 36.0% vs. 27.7%; neurologic 4.9% vs. 3.5% and AKI 55.4% vs. 39.1% (all p<0.001 except for amputation). Non-White race, higher comorbidity, organ failure, and extracorporeal membrane oxygen use were predictors of complications for both cohorts. The pLVAD cohort with complications had higher in-hospital mortality (45.5% vs. 33.1%; adjusted odds ratio 1.65 [95% confidence interval 1.55-1.75]), shorter duration of hospital stay, and higher hospitalization costs compared to the IABP cohort with complications (all p<0.001). These results were consistent in propensity-matched pairs.ConclusionsAMI-CS admissions receiving pLVAD had higher rates of complications compared to the IABP, with worse in-hospital outcomes in the cohort with complications.
| S-EPMC7444810 | biostudies-literature
Project description:Driveline infections (DLI) are common adverse events in left ventricular assist devices (LVADs), leading to severe complications and readmissions. The study aims to characterize risk factors for DLI readmission 2 years postimplant. This single-center study included 183 LVAD patients (43 HeartMate II [HMII], 29 HeartMate 3 [HM3], 111 HVAD) following hospital discharge between 2013 and 2017. Demographics, clinical parameters, and outcomes were retrospectively analyzed and 12.6% of patients were readmitted for DLI, 14.8% experienced DLI but were treated in the outpatient setting, and 72.7% had no DLI. Mean C-reactive protein (CRP), leukocytes and fibrinogen were higher in patients with DLI readmission (P < .02) than in outpatient DLI and patients without DLI, as early as 60 days before readmission. Freedom from DLI readmission was comparable for HMII and HVAD (98% vs. 87%; HR, 4.52; 95% CI, 0.58-35.02; P = .15) but significantly lower for HM3 (72%; HR, 10.82; 95% CI, 1.26-92.68; P = .03). DLI (HR, 1.001; 95% CI, 0.999-1.002; P = .16) or device type had no effect on mortality. DLI readmission remains a serious problem following LVAD implantation, where CRP, leukocytes, and fibrinogen might serve as risk factors already 60 days before. HM3 patients had a higher risk for DLI readmissions compared to HVAD or HMII, possibly because of device-specific driveline differences.
| S-EPMC8247301 | biostudies-literature
Project description:AimsLeft ventricular assist device (LVAD) therapy improves the haemodynamics of advanced heart failure patients. However, it is unknown whether haemodynamic optimization improves haemocompatibility-related adverse events (HRAEs). This study aimed to assess HRAEs in patients with optimized haemodynamics.Methods and resultsEighty-three outpatients [aged 61 (53-67) years, 50 male] underwent a haemodynamic ramp test at 253 (95-652) days after LVAD implantation, and 51 (61%) had optimized haemodynamics (defined as central venous pressure < 12 mmHg, pulmonary artery wedge pressure < 18 mmHg, cardiac index > 2.2 L/min/m2 ) following LVAD speed adjustment. One-year survival free of any HRAEs (non-surgical bleeding, thromboembolic event, pump thrombosis, or neurological event) was achieved in 75% of the optimized group and in 44% of the non-optimized group (hazard ratio 0.36, 95% confidence interval 0.18-0.73, P = 0.003). The net haemocompatibility score, using four escalating tiers of hierarchal severity to derive a total score for events, was significantly lower in the optimized group than the non-optimized group (1.02 vs. 2.00 points/patient; incidence rate ratio 0.51, 95% confidence interval 0.29-0.90, P = 0.021).ConclusionLeft ventricular assist device patients in whom haemodynamics can be optimized had greater freedom from HRAEs compared to those without optimized haemodynamics.
| S-EPMC7147872 | biostudies-literature
Project description:ABSTRACTAdvanced Heart Failure (AHF) is a complex syndrome that affects the physiology of the heart to maintain efficient blood circulation resulting in multiorgan failure and, eventually, death. Left Ventricular Assist Devices (LVADs) have become the cornerstone therapy for AHF patients, both as a bridge to transplantation and as a decisive therapy. Recently the results of the MOMENTUM 3 Trial were published. The trial compared HeartMate 3 LVAD with HeartMate II LVAD in a randomized trial in The Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy with HeartMate 3 (MOMENTUM 3). Of 366 patients, 190 were assigned to the centrifugal-flow pump group (HeartMate 3) and 176 to the axial-flow (HeartMate II) pump group. In the intention-to-treat population, the primary end point occurred in 151 patients (79.5%) in the centrifugal-flow pump group, as compared with 106 (60.2%) in the axial-flow pump group (P < 0.001 for noninferiority). Reoperation for pump malfunction was less frequent in the centrifugal-flow pump group than in the axial-flow pump group (P < 0.001).The results of the MOMENTUM 3 Trial are a big achievement in the cardiovascular world. Any improvement in LVADs that reduces the risk of stroke, perhaps the most feared complication of these devices, would be meaningful. Besides, given the observed lower rate of pump thrombosis and reoperation for pump malfunction, it already seems likely that the HeartMate 3 will supplant the HeartMate II in clinical practice. In addition, the risks that are associated with reoperation undoubtedly counterbalanced any unintentional bias in performing that intervention.
| S-EPMC6292364 | biostudies-other