Right ventricular failure (RVF) increases morbidity and mortality. The RECOVER RIGHT study evaluated the safety and efficacy of a novel percutaneous right ventricular assist device, the Impella RP ...(Abiomed, Danvers, MA), in a prospective, multicenter trial.
Thirty patients with RVF refractory to medical treatment received the Impella RP device at 15 United States institutions. The study population included 2 cohorts: 18 patients with RVF after left ventricular assist device (LVAD) implantation (Cohort A) and 12 patients with RVF after cardiotomy or myocardial infarction (Cohort B). The primary end point was survival to 30 days or hospital discharge (whichever was longer). Major secondary end points included indices of safety and efficacy.
The patients (77% male) were a mean age of 59 ± 15 years, 53% had diabetes, 88.5% had a history of congestive heart failure, and 37.5% had renal dysfunction. Patients were on an average of 3.2 inotropes/pressors. Device delivery was achieved in all but 1 patient. Hemodynamics improved immediately after initiation of Impella RP support, with an increase in cardiac index from 1.8 ± 0.2 to 3.3 ± 0.23 liters/min/m(2) (p < 0.001) and a decrease in central venous pressure from 19.2 ± 4 to 12.6 ± 1 mm Hg (p < 0.001). Patients were supported for an average of 3.0 ± 1.5 days (range, 0.5-7.8 days). The overall survival at 30 days was 73.3%. All patients discharged were alive at 180 days.
In patients with life-threatening RVF, the novel percutaneous Impella RP device was safe, easy to deploy, and reliably resulted in immediate hemodynamic benefit. These data support its probable benefit in this gravely ill patient population.
Right ventricular failure (RVF) after myocardial infarction, cardiotomy, or left ventricular assist device (LVAD) implantation increases morbidity and mortality. RVF also contributes to prolonged ...length of hospital stay and higher costs of care. The aim of this study was to evaluate the efficacy and safety of the Impella RP (Abiomed, Danvers, MA) in patients with severe RVF in these clinical settings.
This is a prospective cohort study of patients with severe RVF treated with a percutaneous right ventricular assist device (RVAD). Sixty patients with RVF refractory to medical treatment received the Impella RP device at 14 United States institutions as part of the Impella RP pre‒ and post‒market approval studies. The study population included 2 cohorts: Cohort A, patients with RVF post-(LVAD) implantation (n = 31); and Cohort B, patients with RVF post-cardiotomy, heart transplant, or myocardial infarction (n = 29). The primary end-point was survival at 30 days or hospital discharge (whichever was longer).
Mean age of patients was 59 ± 15 years; 68% were males, 84% had a history of congestive heart failure, 44% had valvular disease, and 35% had pre-operative renal dysfunction. Patients received an average of 3.4 inotropes/vasopressors before the Impella RP implant. Patients were supported with the Impella RP for 4.0 ± 1.5 (0.5 to 14) days. Hemodynamics improved immediately after initiation of device support, with an increase in cardiac index from 1.9 ± 0.1 to 3.1 ± 0.2 liters/min/m
(p < 0.001) and a decrease in central venous pressure from 19.0 ± 1 to 13 ± 1 mm Hg (p < 0.001). The overall survival at 30 days (or discharge) was 72%.
To the best of our knowledge, this study represents the largest prospective study of patients with life-threatening RVF. Mechanical support with the Impella RP device in patients with RVF resulted in rapid hemodynamic improvement with reversal of shock and favorable survival.
In patients with cryptogenic stroke, transcatheter (TC) closure of a patent foramen ovale (PFO) has not been shown to better prevent recurrent vascular events than medical therapy. However, ...randomized controlled trials (RCT) to date have included few vascular events, and lack of power has been raised as an important concern.
To conduct a systematic review and meta-analysis of existing RCT published studies assessing the recurrence of vascular events after TC PFO closure when compared to medical therapy.
Using the search terms "patent foramen ovale", "PFO", "stroke", "percutaneous closure" and "transcatheter closure", Medline, Pubmed, Embase, and Cochrane databases were reviewed from inception through April 2013, with no language restrictions. Only studies in adult humans were considered. Additional references were obtained from the bibliographies of studies reviewed. The following criteria were used for study selection: 1) randomized controlled trial, 2) subjects were adult patients with cryptogenic stroke who were randomized to TC PFO closure or medical treatment (antiplatelet therapy and/or anticoagulation), and 3) reported outcomes included cardiac death, all death, stroke, transient ischemic attack, and peripheral embolism. Methodological and descriptive data, adverse events (including raw data and risk estimates), as well as procedural success and complications were abstracted in duplicate from each study independently, and agreement was tested. We followed rigorously the recommended guidelines for reporting and conducting and assessing quality of meta-analysis of RCT. The primary endpoints pre-specified in advance were recurrent vascular events, and composite endpoint of death, and recurrent vascular events.
Three studies were identified as meeting selection criteria. These included a total of 2,303 patients, with 1,150 patients randomized to TC PFO closure and 1,153 patients randomized to medical therapy. Mean follow-up was 3.5 years. Baseline characteristics (age, sex, and cardiovascular risk factors) were similar across studies. Intention-to-treat analyses showed a statistically significant risk reduction in stroke and/or transient ischemic attack in the TC PFO closure group when compared to medical treatment, pooled HR = 0.59, 95%CI (0.36-0.97), P = 0.04. The combined outcome of death, and vascular events, showed a borderline statistically significant benefit for TC PFO closure when compared to medical treatment, pooled HR = 0.67, 95%CI (0.44-1.00), P = 0.05 Subjects with a substantial PFO shunt seem to benefit the most with TC PFO closure, pooled HR = 0.35, 95%CI (0.12-1.03), P = 0.06, however, it did not reach statistical significance.
These results suggest that in patients with cryptogenic stroke, TC PFO closure may be beneficial in reducing the risk of recurrent vascular events when compared to medical treatment. The benefit of TC PFO closure may be greater in patients with a substantial shunt.
Background
There are limited data regarding optimal antiplatelet/antithrombotic therapy following transcatheter aortic valve replacement (TAVR).
Methods
In this single‐centre retrospective study ...including TAVR patients from 2012 to 2020, ischemic and bleeding outcomes were compared between antiplatelet (dual antiplatelet DAPT vs. single antiplatelet SAPT) and oral anticoagulation (OAC) groups using incidence rate, Kaplan–Meier and Cox proportional hazards analysis.
Results
Total 492 patients (mean age 79.7 ± 7.7 years, 53.7% males, 83.5% Caucasian) were included. There was higher incidence of 1‐year death or ischemia with DAPT vs. SAPT (23.6 vs. 14.8 per 100 patient‐years PY, incidence rate ratio IRR 1.60, 95% confidence interval CI 0.97–2.68, p = .05), especially in those without coronary artery disease (23.9 vs. 10.7 per 100 PY, IRR 2.24, 95% CI 1.10–4.47, p = .017). There was significantly higher major bleeding in those on OAC vs. no OAC (15 vs. 8 per 100 PY, IRR 1.87, 95% CI 1.10–3.11, p = .016), especially late (>1‐year) bleeding (10.2 vs. 3.6 per 100 PY, IRR 2.81, 95% CI 1.33–5.92, p = .004). In multivariate analysis, DAPT was an independent predictor of death or ischemia (adjusted hazard ratio aHR 1.41, 95% CI 1.01–1.96, p = .041). OAC was an independent predictor of major bleeding (aHR 2.32, 95% CI 1.31–4.13, p = .004).
Conclusions
There is signal to harm with routine use of DAPT post‐TAVR. There is higher incidence of late bleeding post‐TAVR with OAC, suggesting potential role for alternate antithrombotic strategies.
Schematic diagram of study. A total of 492 patients with severe aortic stenosis who underwent transcatheter aortic valve replacement between 2012–2020 were reviewed. There was increased incidence of 1‐year death or ischemia in patients receiving dual antiplatelet therapy, especially in those with no history of coronary artery disease. There was an increased risk of major bleeding and late (>1 year) major bleeding in patients receivingoral anticoagulation (OAC) than those not on OAC.
Accurate assessment of the left atrial appendage (LAA) is important for pre-procedure planning when utilizing device closure for stroke reduction. Sizing is traditionally done with transesophageal ...echocardiography (TEE) but this is not always precise. Three-dimensional (3D) printing of the LAA may be more accurate. 24 patients underwent Watchman device (WD) implantation (71 ± 11 years, 42% female). All had complete 2-dimensional TEE. Fourteen also had cardiac computed tomography (CCT) with 3D printing to produce a latex model of the LAA for pre-procedure planning. Device implantation was unsuccessful in 2 cases (one with and one without a 3D model). The model correlated perfectly with implanted device size (R
2
= 1; p < 0.001), while TEE-predicted size showed inferior correlation (R
2
= 0.34; 95% CI 0.23–0.98, p = 0.03). Fisher’s exact test showed the model better predicted final WD size than TEE (100 vs. 60%, p = 0.02). Use of the model was associated with reduced procedure time (70 ± 20 vs. 107 ± 53 min, p = 0.03), anesthesia time (134 ± 31 vs. 182 ± 61 min, p = 0.03), and fluoroscopy time (11 ± 4 vs. 20 ± 13 min, p = 0.02). Absence of peri-device leak was also more likely when the model was used (92 vs. 56%, p = 0.04). There were trends towards reduced trans-septal puncture to catheter removal time (50 ± 20 vs. 73 ± 36 min, p = 0.07), number of device deployments (1.3 ± 0.5 vs. 2.0 ± 1.2, p = 0.08), and number of devices used (1.3 ± 0.5 vs. 1.9 ± 0.9, p = 0.07). Patient specific models of the LAA improve precision in closure device sizing. Use of the printed model allowed rapid and intuitive location of the best landing zone for the device.
Cirrhotic patients underwent less percutaneous coronary interventions (22% vs 42%; P<0.0001), less thrombolytic agents infusion (0.5% vs 1.5%; p<0.0001) and less coronary artery bypass grafting (5.4% ...vs 9%; p<0.0001) compared to patients with no cirrhosis. Conclusion Presence of liver cirrhosis was associated with increased in-hospital mortality, longer hospital stays and higher hospitalization costs in patients with acute myocardial infarction.
Wandering Acute Myocardial Infarction Joshi, Kamal R., MD; Morris, D. Lynn, MD; Figueredo, Vincent M., MD
The American journal of medicine,
04/2014, Letnik:
127, Številka:
4
Journal Article
Defining the clinical and physiologic significance of an intermediate coronary artery stenosis is aided by measurement of fractional flow reserve (FFR). Adenosine is the most common agent used in the ...cardiac catheterisation laboratory for the measurement of FFR. Regadenoson, a selective adenosine receptor agonist, with fewer side effects than adenosine has been used extensively in stress testing to induce hyperaemia. We postulated that FFR measurements would be equivalent following administration of regadenoson and adenosine.
Twenty patients with an angiographic intermediate coronary artery stenosis (50% to 80%) were included in the study. FFR was measured during three minutes of intravenous (IV) adenosine infusion and for five minutes after an injection of regadenoson. The mean difference between the FFR measured by IV adenosine and IV regadenoson was 0.0040 (min -0.04, max +0.04, standard deviation SD 0.025). There was a strong linear correlation between the FFR measured by IV adenosine and IV regadenoson (R2 linear=0.933). The FFR at maximum hyperaemia was achieved earlier using regadenoson than adenosine (59±24.5 sec vs. 93±44.5 sec, p=0.01).
Regadenoson produces similar pressure-derived FFR compared to IV adenosine infusion.
PDF
