Safety and efficacy outcomes of the Pioneer Plus catheter in endovascular revascularization of lower extremity chronic total occlusions.

OBJECTIVE: Our aim was to evaluate the efficacy and safety outcomes of the Pioneer Plus catheter (Philips, San Diego, Calif) and report the in-hospital and 30-day outcomes of lower extremity chronic total occlusion (CTO) interventions assisted by the Pioneer Plus catheter. In addition, we explored the factors associated with procedural success. METHODS: We conducted a retrospective review of 135 consecutive procedures in 116 patients from July 2011 to September 2018 performed by eight operators with various levels of experience at a high-volume center where the Pioneer Plus catheter was used for lower extremity CTO. The patient demographics, preprocedural symptoms, preprocedural testing results, procedural setting, and angiography findings were abstracted. The outcomes were divided into device-related and procedure-related outcomes. Device-related efficacy outcome included procedural success. Device-related safety outcomes included device-related complications. Procedure-related outcomes included procedure-related complications, 30-day major adverse cardiovascular events, and 30-day major adverse limb events. We conducted univariate comparisons of the provider, patient, and procedural characteristics stratified by procedural success. RESULTS: Procedural success was observed in 118 procedures overall (87.4%), and success rates ≤95.8% were observed for operators with an experience level of >25 devices deployed. No device-related complications, such as pseudoaneurysm formation, vessel perforation, or arteriovenous fistula formation, were observed. The Pioneer Plus catheter was mostly often used for CTO in the superficial femoral and popliteal arteries. Overall, the procedure-related complications included access site hematoma (5.2%), major bleeding (0.7%), pseudoaneurysm formation (0.7%), distal embolization (1.5%), and acute arterial thrombosis (1.5%). The 30-day major adverse limb events included index limb unplanned amputation (0.7%), index limb reintervention (4.4%), and index limb acute limb ischemia (0.7%) and occurred in 5.9% of the procedures. The only factor associated with procedural success was operator experience (P < .0001). CONCLUSIONS: The results from the present study have shown that Pioneer Plus catheter use is safe and effective when used to cross lower extremity CTO. However, further investigation is needed to identify patient- and provider-level factors to optimize patient outcomes.

Systematic review and meta-analysis of outcomes of lower extremity peripheral arterial interventions in patients with and without chronic kidney disease or end-stage renal disease.

OBJECTIVE: Patients with chronic kidney disease (CKD) have a greater risk of peripheral arterial disease (PAD). Although individual studies have documented an association between CKD and/or end-stage renal disease (ESRD) and adverse outcomes in patients undergoing PAD interventions in an era of technological advances in peripheral revascularization, the magnitude of the effect size is unknown. Therefore, we performed a meta-analysis to compare the outcomes of PAD interventions for patients with CKD/ESRD with those patients with normal renal function, stratified by intervention type (endovascular vs surgical), reflecting contemporary practice. METHODS: Five databases were analyzed from January 2000 to June 2019 for studies that had compared the outcomes of lower extremity PAD interventions for patients with CKD/ESRD vs normal renal function. We included both endovascular and open interventions, with an indication of either claudication or critical limb ischemia. We analyzed the pooled odds ratios (ORs) across studies with 95% confidence intervals (CIs) using a random effects model. Funnel plot and exclusion sensitivity analyses were used for bias assessment. RESULTS: Seventeen observational studies with 13,140 patients were included. All included studies, except for two, had accounted for unmeasured confounding using either multivariable regression analysis or case-control matching. The maximum follow-up period was 114 months (range, 0.5-114 months). The incidence of target lesion revascularization (TLR) was greater in those with CKD/ESRD than in those with normal renal function (OR, 1.68; 95% CI, 1.25-2.27; P = .001). The incidence of major amputations (OR, 1.97; 95% CI, 1.37-2.83; P < .001) and long-term mortality (OR, 2.28; 95% CI, 1.45-3.58; P < .001) was greater in those with CKD/ESRD. The greater TLR rates with CKD/ESRD vs normal renal function were only seen with endovascular interventions, with no differences for surgical interventions. The differences in rates of major amputations and long-term mortality between the CKD/ESRD and normal renal function groups were statistically significant, regardless of the intervention type. CONCLUSIONS: Patients with CKD/ESRD who have undergone lower extremity PAD interventions had worse outcomes than those of patients with normal renal function. When stratifying our results by intervention (endovascular vs open surgery), greater rates of TLR for CKD/ESRD were only seen with endovascular and not with open surgical approaches. Major amputations and all-cause mortality were greater in the CKD/ESRD group, irrespective of the indication. Evidence-based strategies to manage this at-risk population who require PAD interventions are essential.

Guideline-Directed Medical Therapy in Patients with Chronic Kidney Disease Undergoing Peripheral Vascular Intervention.

INTRODUCTION: Guideline-directed medical therapy (GDMT) is imperative to improve cardiovascular and limb outcomes for patients with critical limb ischemia (CLI), especially amongst those at highest risk for poor outcomes, including those with comorbid chronic kidney disease (CKD). Our objective was to examine GDMT prescription rates and their variation across individual sites for patients with CLI undergoing peripheral vascular interventions (PVIs), by their comorbid CKD status. METHODS: Patients with CLI who underwent PVI (October 2016-April 2019) were included from the Vascular Quality Initiative (VQI) database. CKD was defined as GFR <60 mL/min/1.73 m2. GDMT included the composite use of antiplatelet therapy and a statin, as well as an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker if hypertension was present. The use of GDMT before and after the index procedure was summarized in those with and without CKD. Adjusted median odds ratios (MORs) for site variability were calculated. RESULTS: The study included 28,652 patients, with a mean age of 69.4 ± 11.7 years, and 40.8% were females. A total of 47.5% had CKD. Patients with CKD versus those without CKD had lower prescription rates both before (31.7% vs. 38.9%) and after (36.5% vs. 48.8%) PVI (p < 0.0001). Significant site variability was observed in the delivery of GDMT in both the non-CKD and CKD groups before and after PVI (adjusted MORs: 1.31-1.41). DISCUSSION/CONCLUSION: In patients with CLI undergoing PVI, patients with comorbid CKD were less likely to receive GDMT. Significant variability of GDMT was observed across sites. These findings indicate that significant improvements must be made in the medical management of patients with CLI, particularly in patients at high risk for poor clinical outcomes.

Impact of Kidney Disease on Peripheral Arterial Interventions: A Systematic Review and Meta-Analysis.

BACKGROUND: There are limited data on outcomes of patients undergoing peripheral arterial disease (PAD) interventions who have comorbid CKD/ESRD versus those who do not have such comorbid condition. We performed a systematic review and meta-analysis to analyze outcomes in this patient population. METHODS: Five databases were searched for studies comparing outcomes of lower extremity PAD interventions for claudication and critical limb ischemia (CLI) in patients with CKD/ESRD versus non-CKD/non-ESRD from January 2000 to June 2019. RESULTS: Our study included 16 observational studies with 44,138 patients. Mean follow-up was 48.9 ± 27.4 months. Major amputation was higher with CKD/ESRD compared with non-CKD/non-ESRD (odds ratio [OR 1.97] [95% confidence interval [CI] 1.39-2.80], p = 0.001). Higher major amputations with CKD/ESRD versus non-CKD/non-ESRD were only observed when indication for procedure was CLI (OR 2.27 [95% CI 1.53-3.36], p < 0.0001) but were similar for claudication (OR 1.15 [95% CI 0.53-2.49], p = 0.72). The risk of early mortality was high with CKD/ESRD patients undergoing PAD interventions compared with non-CKD/non-ESRD (OR 2.55 [95% CI 1.65-3.96], p < 0.0001), which when stratified based on indication, remained higher with CLI (OR 3.14 [95% CI 1.80-5.48], p < 0.0001) but was similar with claudication (OR 1.83 [95% CI 0.90-3.72], p = 0.1). Funnel plot of included studies showed moderate bias. CONCLUSIONS: Patients undergoing lower extremity PAD interventions for CLI who also have comorbid CKD/ESRD have an increased risk of experiencing major amputations and early mortality. Randomized trials to understand outcomes of PAD interventions in this at-risk population are essential.

Echocardiographic parameters to identify sickle cell patients with cardio-pathology.

BACKGROUND: Sickle cell disease (SCD) affects millions of people and causes chronic hemolytic anemia leading to vasculopathies such as pulmonary hypertension and abnormalities in cardiac function that increase complications and mortality. It is therefore crucial to identify cardiac abnormalities in SCD. We aimed to assess the prevalence of echocardiographic parameters in SCD to help identify cardiopulmonary risk. METHODS: Ninety-one patients (53% male), median age of 30, body surface area (BSA) of 1.79 m2 , hemoglobin of 8.8 g/dL, and creatinine of 0.7 mg/dL identified. We retrospectively measured laboratory and echocardiographic parameters in patients with SCD : left ventricular (LV) dimensions, LV ejection fraction (LVEF), LV Myocardial Performance Index (MPI), LV Mass Index (MI), Left Atrial Volume Index (LAVI), Tricuspid Regurgitation Velocity (TRV), tricuspid annular plane systolic excursion (TAPSE), right heart dimensions. RESULTS: Prevalence of left heart abnormalities was 32%: increased LV end-diastolic diameter (EDD), 78%: LV MPI, 21%: diastolic dysfunction, 38%: decreased LVEF, 24%: increased LVMI, and 47%: increased LAVI. Right heart abnormalities were 39%: TAPSE, 38%: increased TRV, and 59%: increased pulmonary systolic pressure (PASP). Multivariate logistic regression analysis was significant for increased LVMI and LAVI in those with hemoglobin ≤8 g/dL (odds ratio (OR) 7.4, 95% confidence interval (CI) 2.23-24.6, P = .001) and (OR 3.32, 95% CI 1.18-9.33, P = .023). CONCLUSIONS: We confirmed increased prevalence of abnormal LVEDD, LVMI, diastolic function, LAVI, and PASP in SCD. In addition, we identified abnormal LV MPI (78%), TAPSE (29%). These parameters may be useful and readily accessible echocardiographic prognostic tools in this population.

Contemporary Trends in Hospital Admissions and Outcomes in Patients With Critical Limb Ischemia: An Analysis From the National Inpatient Sample Database.

BACKGROUND: Critical limb ischemia (CLI) morbidity and mortality rates have historically been disproportionately higher than for other atherosclerotic diseases, however, recent trends have not been reported. In patients admitted with CLI, we aimed to examine trends in in-hospital mortality, major amputations, length of stay, and cost of hospitalizations overall and stratified by type of revascularization procedures. METHODS: Using 2011 to 2017 National Inpatient Sample data, we identified CLI-related admissions based on International Classification of Diseases, Ninth and Tenth Edition, Clinical Modification codes. Primary outcomes of interest were in-hospital mortality and major amputations. Secondary outcomes were the length of stay and cost of hospitalization. We stratified outcomes based on endovascular or open surgical interventions. We also performed hierarchical multivariable regression analyses of outcomes based on age, sex, race, hospital size, type, and location. RESULTS: We identified 2 643 087 CLI-related admissions between 2011 and 2017. CLI admissions increased from 0.9% to 1.4% Ptrend<0.0001 as well as overall peripheral artery disease admissions (4.5%-8.9%, Ptrend<0.0001). In-hospital mortality for the entire CLI cohort decreased from 3.3% to 2.7%, Ptrend<0.0001, and major amputations decreased from 10.9% to 7%, Ptrend<0.0001. A decline was also noted for the length of stay from 5.7 (3.1-10.1) to 5.4 (3.0-9.2) days (Ptrend<0.0001), whereas admission costs increased from USD $11 791 ($6676-$21 712) to $12 597 ($7248-$22 748; Ptrend<0.0001). Endovascular interventions increased (Ptrend<0.0001) against a decline in surgical interventions (Ptrend<0.0001). Black race, female sex, and age ≥60 years were associated with higher in-hospital mortality, whereas Black race, male sex, and age<60 years were associated with higher major amputations. CONCLUSIONS: A relatively small decrease in absolute numbers for mortality and major amputations were observed against a backdrop of increasing CLI admissions over recent years. Patients with CLI received more endovascular interventions than surgical interventions over time. However, admissions for endovascular interventions were characterized by higher risk patient profiles and a higher risk of major amputations as compared with surgical interventions.

Assessment of diastolic function and atrial remodeling by MRI - validation and correlation with echocardiography and filling pressure.

Atrial fibrosis can be estimated noninvasively by magnetic resonance imaging (MRI) using late gadolinium enhancement (LGE), but diastolic dysfunction is clinically assessed by transthoracic echocardiography (TTE), and rarely by MRI. This study aimed to evaluate well-established diastolic parameters using MRI, and validate them with TTE and left ventricular (LV) filling pressures, and to study the relationship between left atrial (LA) remodeling and parameters of diastolic function. The study retrospectively included 105 patients (53 ± 16 years, 39 females) who underwent 3D LGE MRI between 2012 and 2016. Medical charts were reviewed for the echocardiographic diastolic parameters E, A, and e' by TTE, and pressure catheterizations. E and A were measured from in-plane phase-contrast cardiac MRI images, and e' by feature-tracking, and validated with TTE. Interobserver and intraobserver variability was examined. Furthermore, LA volumes, function, and atrial LGE was correlated with diastolic parameters. Evaluation of e' in MRI had strong agreement with TTE (r = 0.75, P < 0.0001), and low interobserver and intraobserver variability. E and A by TTE showed strong agreement to MRI (r = 0.77, P = 0.001; r = 0.73, P = 0.003, for E and A, respectively). Agreement between E/e' by TTE and MRI was strong (r = 0.85, P = 0.0004), and E/e' by TTE correlated moderately to invasive pressures (r = 0.59, P = 0.03). There was a strong relationship between LA LGE and pulmonary capillary wedge pressure (r = 0.81, P = 0.01). In conclusion, diastolic parameters can be measured with good reproducibility by cardiovascular MRI. LA LGE exhibited a strong relationship with pulmonary capillary wedge pressure, an indicator of diastolic function.

Characteristics of Travel-Related Severe Plasmodium vivax and Plasmodium falciparum Malaria in Individuals Hospitalized at a Tertiary Referral Center in Lima, Peru.

Severe Plasmodium falciparum malaria is uncommon in South America. Lima, Peru, while not endemic for malaria, is home to specialized centers for infectious diseases that admit and manage patients with severe malaria (SM), all of whom contracted infection during travel. This retrospective study describes severe travel-related malaria in individuals admitted to one tertiary care referral hospital in Lima, Peru; severity was classified based on criteria published by the World Health Organization in 2000. Data were abstracted from medical records of patients with SM admitted to Hospital Nacional Cayetano Heredia from 2006 to 2011. Of 33 SM cases with complete clinical data, the mean age was 39 years and the male/female ratio was 2.8. Most cases were contracted in known endemic regions within Peru: Amazonia (47%), the central jungle (18%), and the northern coast (12%); cases were also found in five (15%) travelers returning from Africa. Plasmodium vivax was most commonly identified (71%) among the severe infections, followed by P. falciparum (18%); mixed infections composed 11% of the group. Among the criteria of severity, jaundice was most common (58%), followed by severe thrombocytopenia (47%), hyperpyrexia (32%), and shock (15%). Plasmodium vivax mono-infection predominated as the etiology of SM in cases acquired in Peru.