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Impact of Modified H₂FPEF Score on Chronic Limb-Threatening Ischemia in Patients With Lower Extremity Artery Disease Who Underwent Endovascular Therapy.

ABSTRACT: Background: Lower extremity artery disease (LEAD) is an arterial occlusive disease characterized by an insufficient blood supply to the lower limb arteries. The H₂FPEF score, comprising Heavy, Hypertensive, atrial Fibrillation, Pulmonary hypertension, Elder, and Filling pressure, has been developed to identify patients at high risk of heart failure (HF) with preserved ejection fraction. This study assessed the impact of modified H₂FPEF scores on chronic limb-threatening ischemia (CLTI) in patients with LEAD. Methods and Results: This study was a prospective observational study. Because the definition of obesity differs by race, we calculated the modified H₂FPEF score using a body mass index >25 kg/m² to define obesity in 293 patients with LEAD who underwent first endovascular therapy. The primary endpoints were newly developed and recurrent CLTI. The secondary endpoint was a composite of events, including mortality and rehospitalization due to worsening HF and/or CLTI. The modified H₂FPEF score increased significantly with advancing Fontaine classes. Multivariate Cox proportional hazard analysis revealed that the modified H₂FPEF score was an independent predictor of newly developed and recurrent CLTI and composite events. The net reclassification index and integrated discrimination improvement were significantly improved by adding the modified H₂FPEF score to the basic predictors. Conclusions: The modified H₂FPEF score was associated with LEAD severity and future CLTI development, suggesting that it could be a feasible marker for patients with LEAD.

SUBMITTER: Shikama T

PROVIDER: S-EPMC9360988 | biostudies-literature | 2022 Aug

REPOSITORIES: biostudies-literature

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Impact of Modified H2FPEF Score on Chronic Limb-Threatening Ischemia in Patients With Lower Extremity Artery Disease Who Underwent Endovascular Therapy.

Shikama Taku T Otaki Yoichiro Y Watanabe Tetsu T Takahashi Hiroki H Kurokawa Tasuku T Tamura Harutoshi H Kato Shigehiko S Nishiyama Satoshi S Arimoto Takanori T Watanabe Masafumi M

Circulation reports 20220715 8

Background: Lower extremity artery disease (LEAD) is an arterial occlusive disease characterized by an insufficient blood supply to the lower limb arteries. The H2FPEF score, comprising Heavy, Hypertensive, atrial Fibrillation, Pulmonary hypertension, Elder, and Filling pressure, has been developed to identify patients at high risk of heart failure (HF) with preserved ejection fraction. This study assessed the impact of modified H2FPEF scores on chronic limb-t ...[more]

PMID: 36032384

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Project description:ObjectiveHistorically, open surgical bypass provided a durable repair among diabetic patients with chronic limb-threatening ischemia (CLTI). In the current endovascular era, however, the difference in long-term outcomes between first-time revascularization strategies among patients with insulin-dependent diabetes mellitus (IDDM) is poorly understood.MethodsWe reviewed the records of all patients with IDDM undergoing a first-time infrainguinal bypass graft (BPG) or percutaneous transluminal angioplasty with or without stenting (PTA/S) for CLTI at our institution from 2005 to 2014. We defined IDDM as use of chronic insulin administration at baseline to control blood glucose levels and recorded the most recent glycated hemoglobin value available within 3 months before the procedure and fasting blood glucose level on the day of the procedure. We compared rates of wound healing, restenosis, reintervention, major amputation, and mortality between BPG and PTA/S in our population using χ2, Kaplan-Meier, and Cox regression analyses. As a sensitivity analysis, we calculated propensity scores and employed inverse probability weighting to account for nonrandom assignment to BPG vs PTA/S.ResultsOf 2869 infrainguinal revascularizations from 2005 to 2014, 655 limbs (316 BPG, 339 PTA/S) in 580 patients fit our criteria and underwent a first-time revascularization for CLTI. Patients undergoing BPG, compared with PTA/S, were similar in age (69 vs 68 years; P = .55), had similar rates of tissue loss (87% vs 91%; P = .07) and dialysis dependence (26% vs 28%; P = .55), were less likely to be hypertensive (84% vs 92%; P < .001), and were more likely to be current smokers (21% vs 14%; P = .02). There were no differences between BPG and PTA/S patients in mean glycated hemoglobin levels (8.1% vs 8.0%; P = .51) or mean fasting blood glucose levels (158 vs 150 mg/dL; P = .18). Although total hospital length of stay was significantly longer among BPG patients (11 vs 8 days; P < .001), perioperative complications did not differ, including acute kidney injury (19% vs 23%; P = .24), hematoma (6.0% vs 3.8%; P = .20), acute myocardial infarction (1.3% vs 2.1%; P = .43), and mortality (3.8% vs 3.0%; P = .55). BPG-first patients had significantly lower unadjusted 6-month rates of incomplete wound healing (49% vs 57%) and 5-year rates of restenosis (53% vs 72%) and reintervention (47% vs 58%; all P < .05). After adjustment, multivariable analysis suggested PTA/S-first intervention to be significantly associated with higher risk of restenosis (hazard ratio, 1.9; 95% confidence interval, 1.3-2.7) and reintervention (1.9 [1.2-2.7]). These results remained robust after inverse probability weighting.ConclusionsAmong patients with IDDM and CLTI, a bypass-first strategy is associated with similar 30-day outcomes and lower restenosis and reintervention rates. These data suggest that a bypass-first approach may best serve appropriately selected, anatomically suitable patients with IDDM and pedal ischemia that requires revascularization.

Project description:ObjectiveLower extremity bypass (LEB) has traditionally been the "gold standard" in the treatment of critical limb ischemia (CLI). Infrainguinal endovascular intervention (IEI) has become more commonly performed than LEB, but comparative outcomes are limited. We sought to compare rates of major adverse limb events (MALEs) and major adverse cardiovascular events (MACEs) after LEB and IEI in a propensity score-matched, national cohort of patients with CLI.MethodsThe National Surgical Quality Improvement Program (NSQIP) vascular targeted files (2011-2014) for LEB and IEI were merged. CLI patients were identified by ischemic rest pain or tissue loss. Patients were matched on a 1:1 basis for propensity to undergo LEB or IEI. Primary outcomes were 30-day MALEs and MACEs. Within the propensity-matched cohort, multivariate logistic regression was used to identify independent predictors of MALEs and MACEs.ResultsA total of 13,294 LEBs and IEIs were identified, with 8066 cases performed for CLI. Propensity matching identified 3848 cases (1924 per group). There were no differences in preoperative variables between the propensity-matched LEB and IEI groups (all P > .05). At 30 days, rates of MALEs were significantly lower in the LEB group (9.2% LEB vs IEI 12.2%; P = .003). On multivariate logistic regression, bypass with single-segment saphenous vein vs IEI (odds ratio [OR], 0.7; 95% confidence interval [CI], 0.54-0.92; P = .01), bypass with alternative conduit (prosthetic, spliced vein, or composite) vs IEI (OR, 0.7; 95% CI, 0.56-0.98; P = .04), antiplatelet therapy (OR, 0.8; 95% CI, 0.58-1.00; P = .049), and statin therapy (OR, 0.8; 95% CI, 0.62-0.99; P = .04) were protective against MALEs, whereas infrageniculate intervention (OR, 1.4; 95% CI, 1.09-1.72; P = .01) and a history of prior bypass of the same arterial segment (OR, 1.8; 95% CI, 1.41-2.41; P <. 0001) were predictive. Rates of 30-day MACEs were not significantly different (4.9% LEB vs 3.7% IEI; P = .07) between the groups. Independent predictors of MACEs included age (OR, 1.02; 95% CI, 1.01-1.04; P = .01), steroid use (OR, 1.8; 95% CI, 1.08-2.99; P = .03), congestive heart failure (OR, 1.7; 95% CI, 1.00-1.96; P = .02), beta blocker use (OR, 1.6; 95% CI, 1.09-1.43; P = .01), dialysis (OR, 2.3; 95% CI, 1.55-3.45; P < .0001), totally dependent functional status (OR, 3.1; 95% CI, 1.25-7.58; P = .02), and suboptimal conduit for LEB compared with IEI (OR, 1.6; 95% CI, 1.08-2.36; P = .02).ConclusionsWithin this large, propensity-matched, national cohort, LEB predicted lower risk-adjusted 30-day MALE rate compared with IEI. Furthermore, there was no difference in 30-day MACE rate between the groups despite higher inherent risk with open surgical procedures. Therefore, this study supports the effectiveness and primacy of LEB for revascularization in CLI.

Project description:IntroductionChronic limb-threatening ischemia (CLTI) is the end stage of peripheral arterial disease (PAD) and is associated with high amputation rates, mortality and disease-related health care costs. In infrapopliteal arterial disease (IPAD), endovascular revascularization should be considered for the majority of anatomical and clinical subgroups of CLTI. However, a gap of high-quality evidence exists in this field. The aim of the Dutch Chronic Lower Limb-Threatening Ischemia Registry (THRILLER) is to collect real world data on popliteal and infrapopliteal endovascular interventions.MethodsTHRILLER is a clinician-driven, prospective, multicenter, observational registry including all consecutive patients that undergo a popliteal or infrapopliteal endovascular intervention in seven Dutch hospitals. We estimate that THRILLER will include 400-500 interventions annually. Standardized follow-up visits with wound monitoring, toe pressure measurement and duplex ultrasonography will be scheduled at 6-8 weeks and 12 months after the intervention. The independent primary endpoints are primary patency, limb salvage and amputation free survival. Patients must give informed consent before participation and will be included according to predefined reporting standards. A data log of patients who meet the inclusion criteria but are not included in the registry will be maintained. We intend to conduct the first interim analysis two years after the start of inclusion. The results will be published in a scientific journal.DiscussionDespite innovations in medical therapy and revascularization techniques, patients with CLTI undergoing endovascular revascularization still have a moderate prognosis. Previous prospective cohort studies were hampered by small sample sizes or heterogeneous reporting. Randomized controlled trials (RCTs) have high costs, potential conflicts of interest and give a limited reflection of daily practice. THRILLER aims to provide the largest prospective well phenotyped up-to-date dataset on treatment outcomes in CLTI patients to answer multiple underexplored research questions regarding diagnostics, medication, patient selection, treatment strategies and post intervention follow-up.

Project description:BackgroundAlthough open surgical bypass remains the standard revascularization strategy for patients with critical limb ischemia (CLI), many centers now perform peripheral endovascular intervention (PVI) as the first-line treatment for these patients. We sought to determine the effect of a prior ipsilateral PVI (iPVI) on the outcome of subsequent lower extremity bypass (LEB) in patients with CLI.MethodsA retrospective cohort analysis of all patients undergoing infrainguinal LEB between 2003 and 2009 within hospitals comprising the Vascular Study Group of New England (VSGNE) was performed. Primary study endpoints were major amputation and graft occlusion at 1 year postoperatively. Secondary outcomes included in-hospital major adverse events (MAE), 1-year mortality, and composite 1-year major adverse limb events (MALE). Event rates were determined using life table analyses and comparisons were performed using the log-rank test. Multivariate predictors were determined using a Cox proportional hazards model with multilevel hierarchical adjustment.ResultsOf 1880 LEBs performed, 32% (n = 603) had a prior infrainguinal revascularization procedure (iPVI, 7%; ipsilateral bypass, 15%; contralateral PVI, 3%; contralateral bypass, 17%). Patients with prior iPVI, compared with those without a prior iPVI, were more likely to be women (32 vs 41%; P = .04), less likely to have tissue loss (52% vs 63%; P = .02), more likely to require arm vein conduit (16% vs 5%; P = .001), and more likely to be on statin (71% vs 54%; P = .01) and beta blocker therapy (92% vs 81%; P = .01) at the time of their bypass procedure. Other demographic factors were similar between these groups. Prior PVI or bypass did not alter 30-day MAE and 1-year mortality after the index bypass. In contrast, 1-year major amputation and 1-year graft occlusion rates were significantly higher in patients who had prior iPVI than those without (31% vs 20%; P = .046 and 28% vs 18%; P = .009), similar to patients who had a prior ipsilateral bypass (1 year major amputation, 29% vs 20%; P = .022; 1 year graft occlusion, 33% vs 18%; P = .001). Independent multivariate predictors of higher 1-year amputation and graft occlusion rates were prior iPVI, prior ipsilateral bypass, dialysis dependence, prosthetic conduit and distal (tibial and pedal) bypass target.ConclusionsPrior iPVI is highly predictive for poor outcome in patients undergoing LEB for CLI with higher 1-year amputation and graft occlusion rates than those without prior revascularization, similar to prior ipsilateral bypass These findings provide information, which may help with the complex decisions surrounding revascularization options in patients with CLI.

Project description:PurposeEndovascular revascularization is the preferred treatment to improve perfusion of the lower extremity in patients with chronic limb-threatening ischemia (CLTI). Patients with CLTI often present with stenotic-occlusive lesions involving the infrapopliteal arteries. Although the frequency of treating infrapopliteal lesions is increasing, the reintervention rates remain high. This study aimed to determine the outcomes and patency of infrapopliteal endovascular reinterventions.MethodsThis retrospective, multicenter cohort study of 3 Dutch hospitals included patients who underwent an endovascular infrapopliteal reintervention in 2015 up to 2021 after a primary infrapopliteal intervention for CLTI. The outcome measures after the reintervention procedures included technical success rate, the mortality rate and complication rate (any deviation from the normal postinterventional course) at 30 days, overall survival, amputation-free survival (AFS), freedom from major amputation, major adverse limb event (MALE), and recurrent reinterventions (a reintervention following the infrapopliteal reintervention). Cox proportional hazard models were used to determine risk factors for AFS and freedom from major amputation or recurrent reintervention.ResultsEighty-one patients with CLTI were included. A total of 87 limbs underwent an infrapopliteal reintervention in which 122 lesions were treated. Technical success was achieved in 99 lesions (81%). The 30-day mortality rate was 1%, and the complication rate was 13%. Overall survival and AFS at 1 year were 69% (95% confidence interval [CI], 55%-79%) and 54% (95% CI, 37%-67%), respectively, and those at 2.5 years were 45% (95% CI, 33%-56%) and 21% (95% CI, 11%-33%), respectively. Freedom from major amputation, MALE, and recurrent reinterventions at 1 year and 2.5 years were 59% (95% CI, 46%-70%) and 41% (95% CI, 25%-56%); 54% (95% CI, 41%-65%) and 36% (95% CI, 21%-51%); and 68% (95% CI, 55%-78%) and 51% (95% CI, 33%-66%), respectively. A Global Limb Anatomic Staging System score of III showed an increased hazard ratio of 2.559 (95% CI, 1.078-6.072; p=0.033) for freedom of major amputation or recurrent reintervention.ConclusionsThe results of this study indicate that endovascular infrapopliteal reinterventions can be performed with acceptable 30-day mortality and complication rates. However, outcomes and patency were moderate to poor, with low AFS, high rates of major amputations, and recurrent reinterventions.Clinical impactThis multicenter retrospective study evaluating outcome and patency of endovascular infrapopliteal reinterventions for CLTI, shows that endovascular infrapopliteal reinterventions can be performed with acceptable 30-day mortality and complication rates. However, the short- and mid-term outcomes of the infrapopliteal reinterventions were moderate to poor, with low rates of AFS and a high need for recurrent reinterventions. While the frequency of performing infrapopliteal reinterventions is increasing with additional growing complexity of the disease, alternative treatment options such as venous bypass grafting or deep venous arterialization may be considered and should be studied in randomized controlled trials.

Project description:BackgroundMany believe that variation in vascular practice may affect limb salvage rates in patients with severe peripheral arterial disease. However, the extent of variation in procedural vascular care obtained by patients with critical limb ischemia (CLI) remains unknown.Methods and resultsBy using Medicare 2003 to 2006 data, we identified all patients with CLI who underwent major lower extremity amputation in the 306 hospital referral regions described in the Dartmouth Atlas of Healthcare. For each patient, we studied the use of lower extremity vascular procedures (open surgery or endovascular intervention) in the year before amputation. Our main outcome measure was the intensity of vascular care, defined as the proportion of patients in the hospital referral region undergoing a vascular procedure in the year before amputation. Overall, 20,464 patients with CLI underwent major lower extremity amputations during the study period, and collectively underwent 25,800 vascular procedures in the year before undergoing amputation. However, these procedures were not distributed evenly: 54% of patients had no vascular procedures performed in the year before amputation, 14% underwent 1 vascular procedure, and 32% underwent >1 vascular procedure. In the regions in the lowest quintile of vascular intensity, vascular procedures were performed in 32% of patients. Conversely, in the regions in the highest quintile of vascular intensity, revascularization was performed in 58% of patients in the year before amputation (P<0.0001). In analyses accounting for differences in age, sex, race, and comorbidities, patients in high-intensity regions were 2.4 times as likely to undergo revascularization in the year before amputation than patients in low-intensity regions (adjusted odds ratio, 2.4; 95% CI, 2.1-2.6; P<0.001).ConclusionsSignificant variation exists in the intensity of vascular care provided to patients in the year before major amputation. In some regions, patients receive intensive care, whereas in other regions, far less vascular care is provided. Future work is needed to determine the association between intensity of vascular care and limb salvage.

Dataset Information

Impact of Modified H₂FPEF Score on Chronic Limb-Threatening Ischemia in Patients With Lower Extremity Artery Disease Who Underwent Endovascular Therapy.

Publications

Impact of Modified H<sub>2</sub>FPEF Score on Chronic Limb-Threatening Ischemia in Patients With Lower Extremity Artery Disease Who Underwent Endovascular Therapy.

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