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The Journal of Urology Nov 2018We evaluated contemporary practice patterns in the management of small renal masses. (Comparative Study)
Comparative Study
PURPOSE
We evaluated contemporary practice patterns in the management of small renal masses.
MATERIALS AND METHODS
We identified 52,804 patients in the NCDB (National Cancer Database) who were diagnosed with a small renal mass (4 cm or less) between 2010 and 2014. Utilization trends of active surveillance, ablation and robotic, laparoscopic and open surgical techniques were compared among all comers, elderly patients 75 years old or older and individuals with competing health risks, defined as a Charlson index of 2 or greater. Multivariable logistic regression models were used to assess factors associated with robotic renal surgery and active surveillance.
RESULTS
Surgery remained the primary treatment modality across all years studied, performed in 75.0% and 74.2% of cases in 2010 and 2014, respectively. Although increases in active surveillance from 4.8% in 2010 to 6.0% in 2014 (p <0.001) and robotic renal surgery (22.1% in 2010 to 39.7% in 2014, p <0.001) were observed, the increase in the proportion of small renal masses treated with robotic partial and radical nephrectomy was greater than that of active surveillance (82.0% and 63.0%, respectively, vs 25.0%). Subgroup analyses in individuals 75 years old or older, or with a Charlson index of 2 or greater likewise revealed preferential increases in robotic surgery vs active surveillance. On multivariable analysis later year of diagnosis was associated with increased performance of robotic renal surgery compared to active surveillance (2014 vs 2010 OR 1.44, 95% CI 1.20-1.72, p <0.001) and nonrobotic procedural interventions (2014 vs 2010 OR 2.59, 95% CI 2.30-2.93, p <0.001).
CONCLUSIONS
Robotic surgical extirpation has outpaced the adoption of active surveillance of small renal masses. This raises concern that the diffusion of robotic technology propagates overtreatment, particularly among elderly and comorbid individuals.
Topics: Age Factors; Aged; Aged, 80 and over; Cohort Studies; Databases, Factual; Female; Humans; Kidney Neoplasms; Logistic Models; Male; Medical Overuse; Middle Aged; Multivariate Analysis; Neoplasm Invasiveness; Neoplasm Staging; Nephrectomy; Patient Safety; Prognosis; Retrospective Studies; Risk Assessment; Robotic Surgical Procedures; Watchful Waiting
PubMed: 29792881
DOI: 10.1016/j.juro.2018.05.081 -
Current Urology Reports Jul 2017Growing research supports the use of multiparametric magnetic resonance imaging (mpMRI) for the evaluation of localized prostate cancer (PCa). We highlight contemporary... (Review)
Review
PURPOSE OF REVIEW
Growing research supports the use of multiparametric magnetic resonance imaging (mpMRI) for the evaluation of localized prostate cancer (PCa). We highlight contemporary evidence supporting its use in active surveillance (AS).
RECENT FINDINGS
The emerging approach to localized PCa favors risk-adapted screening, image-guided biopsies, and selective therapeutic interventions. mpMRI is increasingly critical to achieve each of these aims. Early evidence suggests a value of mpMRI before initial biopsy to guide fusion targeting and to rule out non-organ confined disease as well as in the initiation and serial monitoring of men on AS. There remain concerns regarding understaging cancer with mpMRI and the standardization of expertise beyond the most experienced centers. mpMRI is emerging as a critical decision point for staging localized PCa and guiding AS strategies. While there is increasing enthusiasm, the optimal clinical scenario and sequencing remains to be defined.
Topics: Humans; Image-Guided Biopsy; Magnetic Resonance Imaging; Male; Prostatic Neoplasms; Watchful Waiting
PubMed: 28589398
DOI: 10.1007/s11934-017-0699-2 -
Clinical Cancer Research : An Official... Feb 2023Watchful waiting (WW) can be considered for patients with metastatic clear-cell renal cell carcinoma (mccRCC) with good or intermediate prognosis, especially those with...
PURPOSE
Watchful waiting (WW) can be considered for patients with metastatic clear-cell renal cell carcinoma (mccRCC) with good or intermediate prognosis, especially those with <2 International Metastatic RCC Database Consortium criteria and ≤2 metastatic sites [referred to as watch and wait ("W&W") criteria]. The IMaging PAtients for Cancer drug SelecTion-Renal Cell Carcinoma study objective was to assess the predictive value of [18F]FDG PET/CT and [89Zr]Zr-DFO-girentuximab PET/CT for WW duration in patients with mccRCC.
EXPERIMENTAL DESIGN
Between February 2015 and March 2018, 48 patients were enrolled, including 40 evaluable patients with good (n = 14) and intermediate (n = 26) prognosis. Baseline contrast-enhanced CT, [18F]FDG and [89Zr]Zr-DFO-girentuximab PET/CT were performed. Primary endpoint was the time to disease progression warranting systemic treatment. Maximum standardized uptake values (SUVmax) were measured using lesions on CT images coregistered to PET/CT. High and low uptake groups were defined on the basis of median geometric mean SUVmax of RECIST-measurable lesions across patients.
RESULTS
The median WW time was 16.1 months [95% confidence interval (CI): 9.0-31.7]. The median WW period was shorter in patients with high [18F]FDG tumor uptake than those with low uptake (9.0 vs. 36.2 months; HR, 5.6; 95% CI: 2.4-14.7; P < 0.001). Patients with high [89Zr]Zr-DFO-girentuximab tumor uptake had a median WW period of 9.3 versus 21.3 months with low uptake (HR, 1.7; 95% CI: 0.9-3.3; P = 0.13). Patients with "W&W criteria" had a longer median WW period of 21.3 compared with patients without: 9.3 months (HR, 1.9; 95% CI: 0.9-3.9; Pone-sided = 0.034). Adding [18F]FDG uptake to the "W&W criteria" improved the prediction of WW duration (P < 0.001); whereas [89Zr]Zr-DFO-girentuximab did not (P = 0.53).
CONCLUSIONS
In patients with good- or intermediate-risk mccRCC, low [18F]FDG uptake is associated with prolonged WW. This study shows the predictive value of the "W&W criteria" for WW duration and shows the potential of [18F]FDG-PET/CT to further improve this.
Topics: Humans; Carcinoma, Renal Cell; Positron Emission Tomography Computed Tomography; Fluorodeoxyglucose F18; Radioisotopes; Zirconium; Watchful Waiting; Prognosis; Radiopharmaceuticals
PubMed: 36394882
DOI: 10.1158/1078-0432.CCR-22-0921 -
JAMA Oncology Jan 2024In March 2023, the National Comprehensive Cancer Network endorsed watch and wait for those with complete clinical response to total neoadjuvant therapy. Neoadjuvant... (Observational Study)
Observational Study
IMPORTANCE
In March 2023, the National Comprehensive Cancer Network endorsed watch and wait for those with complete clinical response to total neoadjuvant therapy. Neoadjuvant therapy is highly efficacious, so this recommendation may have broad implications, but the current trends in organ preservation in the US are unknown.
OBJECTIVE
To describe organ preservation trends among patients with rectal cancer in the US from 2006 to 2020.
DESIGN, SETTING, AND PARTICIPANTS
This retrospective, observational case series included adults (aged ≥18 years) with rectal adenocarcinoma managed with curative intent from 2006 to 2020 in the National Cancer Database.
EXPOSURE
The year of treatment was the primary exposure. The type of therapy was chemotherapy, radiation, or surgery (proctectomy, transanal local excision, no tumor resection). The timing of therapy was classified as neoadjuvant or adjuvant.
MAIN OUTCOMES AND MEASURES
The primary outcome was the absolute annual proportion of organ preservation after radical treatment, defined as chemotherapy and/or radiation without tumor resection, proctectomy, or transanal local excision. A secondary analysis examined complete pathologic responses among eligible patients.
RESULTS
Of the 175 545 patients included, the mean (SD) age was 63 (13) years, 39.7% were female, 17.4% had clinical stage I disease, 24.7% had stage IIA to IIC disease, 32.1% had stage IIIA to IIIC disease, and 25.7% had unknown stage. The absolute annual proportion of organ preservation increased by 9.8 percentage points (from 18.4% in 2006 to 28.2% in 2020; P < .001). From 2006 to 2020, the absolute rate of organ preservation increased by 13.0 percentage points for patients with stage IIA to IIC disease (19.5% to 32.5%), 12.9 percentage points for patients with stage IIIA to IIC disease (16.2% to 29.1%), and 10.1 percentage points for unknown stages (16.5% to 26.6%; all P < .001). Conversely, patients with stage I disease experienced a 6.1-percentage point absolute decline in organ preservation (from 26.4% in 2006 to 20.3% in 2020; P < .001). The annual rate of transanal local excisions decreased for all stages. In the subgroup of 80 607 eligible patients, the proportion of complete pathologic responses increased from 6.5% in 2006 to 18.8% in 2020 (P < .001).
CONCLUSIONS AND RELEVANCE
This case series shows that rectal cancer is increasingly being managed medically, especially among patients whose treatment historically relied on proctectomy. Given the National Comprehensive Cancer Network endorsement of watch and wait, the increasing trends in organ preservation, and the nearly 3-fold increase in complete pathologic responses, international professional societies should urgently develop multidisciplinary core outcome sets and care quality indicators to ensure high-quality rectal cancer research and care delivery accounting for organ preservation.
Topics: Adolescent; Adult; Female; Humans; Male; Middle Aged; Chemoradiotherapy; Neoadjuvant Therapy; Neoplasm Recurrence, Local; Neoplasm Staging; Organ Preservation; Pathologic Complete Response; Rectal Neoplasms; Retrospective Studies; Treatment Outcome; Watchful Waiting
PubMed: 37943566
DOI: 10.1001/jamaoncol.2023.4845 -
The Cochrane Database of Systematic... Jul 2021Stem cell therapy (SCT) has been proposed as an alternative treatment for dilated cardiomyopathy (DCM), nonetheless its effectiveness remains debatable. (Meta-Analysis)
Meta-Analysis
BACKGROUND
Stem cell therapy (SCT) has been proposed as an alternative treatment for dilated cardiomyopathy (DCM), nonetheless its effectiveness remains debatable.
OBJECTIVES
To assess the effectiveness and safety of SCT in adults with non-ischaemic DCM.
SEARCH METHODS
We searched CENTRAL in the Cochrane Library, MEDLINE, and Embase for relevant trials in November 2020. We also searched two clinical trials registers in May 2020.
SELECTION CRITERIA
Eligible studies were randomized controlled trials (RCT) comparing stem/progenitor cells with no cells in adults with non-ischaemic DCM. We included co-interventions such as the administration of stem cell mobilizing agents. Studies were classified and analysed into three categories according to the comparison intervention, which consisted of no intervention/placebo, cell mobilization with cytokines, or a different mode of SCT. The first two comparisons (no cells in the control group) served to assess the efficacy of SCT while the third (different mode of SCT) served to complement the review with information about safety and other information of potential utility for a better understanding of the effects of SCT.
DATA COLLECTION AND ANALYSIS
Two review authors independently screened all references for eligibility, assessed trial quality, and extracted data. We undertook a quantitative evaluation of data using random-effects meta-analyses. We evaluated heterogeneity using the I² statistic. We could not explore potential effect modifiers through subgroup analyses as they were deemed uninformative due to the scarce number of trials available. We assessed the certainty of the evidence using the GRADE approach. We created summary of findings tables using GRADEpro GDT. We focused our summary of findings on all-cause mortality, safety, health-related quality of life (HRQoL), performance status, and major adverse cardiovascular events.
MAIN RESULTS
We included 13 RCTs involving 762 participants (452 cell therapy and 310 controls). Only one study was at low risk of bias in all domains. There were many shortcomings in the publications that did not allow a precise assessment of the risk of bias in many domains. Due to the nature of the intervention, the main source of potential bias was lack of blinding of participants (performance bias). Frequently, the format of the continuous data available was not ideal for use in the meta-analysis and forced us to seek strategies for transforming data in a usable format. We are uncertain whether SCT reduces all-cause mortality in people with DCM compared to no intervention/placebo (mean follow-up 12 months) (risk ratio (RR) 0.84, 95% confidence interval (CI) 0.54 to 1.31; I² = 0%; studies = 7, participants = 361; very low-certainty evidence). We are uncertain whether SCT increases the risk of procedural complications associated with cells injection in people with DCM (data could not be pooled; studies = 7; participants = 361; very low-certainty evidence). We are uncertain whether SCT improves HRQoL (standardized mean difference (SMD) 0.62, 95% CI 0.01 to 1.23; I² = 72%; studies = 5, participants = 272; very low-certainty evidence) and functional capacity (6-minute walk test) (mean difference (MD) 70.12 m, 95% CI -5.28 to 145.51; I² = 87%; studies = 5, participants = 230; very low-certainty evidence). SCT may result in a slight functional class (New York Heart Association) improvement (data could not be pooled; studies = 6, participants = 398; low-certainty evidence). None of the included studies reported major adverse cardiovascular events as defined in our protocol. SCT may not increase the risk of ventricular arrhythmia (data could not be pooled; studies = 8, participants = 504; low-certainty evidence). When comparing SCT to cell mobilization with granulocyte-colony stimulating factor (G-CSF), we are uncertain whether SCT reduces all-cause mortality (RR 0.46, 95% CI 0.16 to 1.31; I² = 39%; studies = 3, participants = 195; very low-certainty evidence). We are uncertain whether SCT increases the risk of procedural complications associated with cells injection (studies = 1, participants = 60; very low-certainty evidence). SCT may not improve HRQoL (MD 4.61 points, 95% CI -5.62 to 14.83; studies = 1, participants = 22; low-certainty evidence). SCT may improve functional capacity (6-minute walk test) (MD 140.14 m, 95% CI 119.51 to 160.77; I² = 0%; studies = 2, participants = 155; low-certainty evidence). None of the included studies reported MACE as defined in our protocol or ventricular arrhythmia. The most commonly reported outcomes across studies were based on physiological measures of cardiac function where there were some beneficial effects suggesting potential benefits of SCT in people with non-ischaemic DCM. However, it is unclear if this intermediate effects translates into clinical benefits for these patients. With regard to specific aspects related to the modality of cell therapy and its delivery, uncertainties remain as subgroup analyses could not be performed as planned, making it necessary to wait for the publication of several studies that are currently in progress before any firm conclusion can be reached.
AUTHORS' CONCLUSIONS
We are uncertain whether SCT in people with DCM reduces the risk of all-cause mortality and procedural complications, improves HRQoL, and performance status (exercise capacity). SCT may improve functional class (NYHA), compared to usual care (no cells). Similarly, when compared to G-CSF, we are also uncertain whether SCT in people with DCM reduces the risk of all-cause mortality although some studies within this comparison observed a favourable effect that should be interpreted with caution. SCT may not improve HRQoL but may improve to some extent performance status (exercise capacity). Very low-quality evidence reflects uncertainty regarding procedural complications. These suggested beneficial effects of SCT, although uncertain due to the very low certainty of the evidence, are accompanied by favourable effects on some physiological measures of cardiac function. Presently, the most effective mode of administration of SCT and the population that could benefit the most is unclear. Therefore, it seems reasonable that use of SCT in people with DCM is limited to clinical research settings. Results of ongoing studies are likely to modify these conclusions.
Topics: Arrhythmias, Cardiac; Bias; Cardiomyopathy, Dilated; Cause of Death; Granulocyte Colony-Stimulating Factor; Humans; Placebos; Quality of Life; Randomized Controlled Trials as Topic; Severity of Illness Index; Stem Cell Transplantation; Walk Test; Watchful Waiting
PubMed: 34286511
DOI: 10.1002/14651858.CD013433.pub2 -
JAMA Surgery Mar 2018The 2012 international consensus guidelines defined a subcategory of pancreatic branch duct intraductal papillary mucinous neoplasms with “worrisome features,” which... (Comparative Study)
Comparative Study Review
IMPORTANCE
The 2012 international consensus guidelines defined a subcategory of pancreatic branch duct intraductal papillary mucinous neoplasms with “worrisome features,” which may be followed with close surveillance. However, given the poor prognosis of invasive malignancy, the role of early, upfront resection requires further investigation.
OBJECTIVE
To compare the utility of upfront resection vs long-term surveillance. We hypothesized that surveillance of these cystic neoplasms would offer greater long-term utility.
DESIGN, SETTING, AND PARTICIPANTS
A Markov decision analysis model was constructed to estimate and compare 2 management strategies: early resection and long-term surveillance. Estimates for the utility of outcomes, probabilities of transitions between disease states, and probabilities of surgical morbidity were derived from a literature review of articles published between 1997 and 2014. The comparative effectiveness model’s variable estimates were based on data published predominantly by high-volume, tertiary referral centers. Model probability variable estimates were derived from large, retrospective, single-institution reports. For utility variables, estimates derived from studies using standard-gamble or time-tradeoff methods were given greater weight.
MAIN OUTCOMES AND MEASURES
Expected utility was measured in terms of quality-adjusted life years using 3% annual discount. Probabilistic and 1-way sensitivity analyses were performed to assess the potential effects of uncertainty in estimates of key model variables.
RESULTS
Early resection yielded 11.63 quality-adjusted life-years during 20 years of follow-up compared with 11.06 for surveillance. Probabilistic sensitivity analysis indicated that resection has a 94% likelihood of being more effective than surveillance. Early resection obtained greater utility only if each of the following criteria are met: life expectancy is at least 18 years, surgical mortality is less than 4.3%, and baseline preoperative utility is at least 0.78. Additional drivers of the model outcomes include the rate of progression from worrisome to high-risk features and the likelihood of finding cancer on resection for neoplasms with high-risk stigmata.
CONCLUSIONS AND RELEVANCE
Early resection compares favorably with surveillance in the management of branch duct intraductal papillary mucinous neoplasms with worrisome features. However, careful consideration of patient factors and surgeon outcomes is imperative.
Topics: Comparative Effectiveness Research; Humans; Life Expectancy; Markov Chains; Models, Statistical; Pancreatectomy; Pancreatic Intraductal Neoplasms; Quality-Adjusted Life Years; Watchful Waiting
PubMed: 29167899
DOI: 10.1001/jamasurg.2017.4587 -
Current Urology Reports Jul 2017Previously considered an absolute contraindication, the use of testosterone therapy in men with prostate cancer has undergone an important paradigm shift. Recent data... (Review)
Review
PURPOSE OF REVIEW
Previously considered an absolute contraindication, the use of testosterone therapy in men with prostate cancer has undergone an important paradigm shift. Recent data has changed the way we approach the treatment of testosterone deficiency in men with prostate cancer. In the current review, we summarize and analyze the literature surrounding effects of testosterone therapy on patients being treated in an active surveillance protocol as well as following definitive treatment for prostate cancer.
RECENT FINDINGS
The conventional notion that defined the relationship between increasing testosterone and prostate cancer growth was based on limited studies and anecdotal case reports. Contemporary evidence suggests testosterone therapy in men with testosterone deficiency does not increase prostate cancer risk or the chances of more aggressive disease at prostate cancer diagnosis. Although the studies are limited, men who received testosterone therapy for localized disease did not have higher rates of recurrences or worse clinical outcomes. Current review of the literature has not identified adverse progression events for patients receiving testosterone therapy while on active surveillance/watchful waiting or definitive therapies. The importance of negative effects of testosterone deficiency on health and health-related quality of life measures has pushed urologists to re-evaluate the role testosterone plays in prostate cancer. This led to a paradigm shift that testosterone therapy might in fact be a viable option for a select group of men with testosterone deficiency and a concurrent diagnosis of prostate cancer.
Topics: Androgens; Contraindications, Drug; Disease Progression; Humans; Hypogonadism; Male; Prostatic Neoplasms; Quality of Life; Testosterone; Watchful Waiting
PubMed: 28589395
DOI: 10.1007/s11934-017-0695-6 -
Progress in Community Health... 2017The United States is facing a surge in the number of school-based health centers (SBHCs) owing to their success in delivering positive health outcomes and increasing...
BACKGROUND
The United States is facing a surge in the number of school-based health centers (SBHCs) owing to their success in delivering positive health outcomes and increasing access to care. To preserve this success, experts have developed frameworks for creating sustainable SBHCs; however, little research has affirmed or added to these models.
OBJECTIVES
This research seeks to analyze elements of sustainability in a case study of three SBHCs in San Diego, California, with the purpose of creating a research-based framework of SBHC sustainability to supplement expertly derived models.
METHODS
Using a mixed methods study design, data were collected from interviews with SBHC stakeholders, observations in SBHCs, and SBHC budgets. A grounded theory qualitative analysis and a quantitative budget analysis were completed to develop a theoretical framework for the sustainability of SBHCs.
RESULTS
Forty-one interviews were conducted, 6 hours of observations were completed, and 3 years of SBHC budgets were analyzed to identify care coordination, community buy-in, community awareness, and SBHC partner cooperation as key themes of sustainability promoting patient retention for sustainable billing and reimbursement levels.
CONCLUSIONS
These findings highlight the unique ways in which SBHCs gain community buy-in and awareness by becoming trusted sources of comprehensive and coordinated care within communities and among vulnerable populations. Findings also support ideas from expert models of SBHC sustainability calling for well-defined and executed community partnerships and quality coordinated care in the procurement of sustainable SBHC funding.
Topics: Budgets; California; Health Services Research; Humans; Observation; Qualitative Research; School Health Services; Stakeholder Participation
PubMed: 29056614
DOI: 10.1353/cpr.2017.0039 -
European Journal of Cancer (Oxford,... Nov 2015Prostate cancer is the second most frequently diagnosed cancer and the sixth leading cause of cancer death in males. A systematic review of randomised controlled trials... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Prostate cancer is the second most frequently diagnosed cancer and the sixth leading cause of cancer death in males. A systematic review of randomised controlled trials (RCTs) of radiotherapy and other non-pharmacological management options for localised prostate cancer was undertaken.
METHODS
A search of thirteen databases was carried out until March 2014. RCTs comparing radiotherapy (brachytherapy (BT) or external beam radiotherapy (EBRT)) to other management options i.e. radical prostatectomy (RP), active surveillance, watchful waiting, high intensity focused ultrasound (HIFU), or cryotherapy; each alone or in combination, e.g. with adjuvant hormone therapy (HT), were included. Methods followed guidance by the Centre for Reviews and Dissemination and the Cochrane Collaboration. Indirect comparisons were calculated using the Bucher method.
RESULTS
Thirty-six randomised controlled trials (RCTs, 134 references) were included. EBRT, BT and RP were found to be effective in the management of localised prostate cancer. While higher doses of EBRT seem to be related to favourable survival-related outcomes they might, depending on technique, involve more adverse events, e.g. gastrointestinal and genitourinary toxicity. Combining EBRT with hormone therapy shows a statistically significant advantage regarding overall survival when compared to EBRT alone (Relative risk 1.21, 95% confidence interval 1.12-1.30). Aside from mixed findings regarding urinary function, BT and radical prostatectomy were comparable in terms of quality of life and biochemical progression-free survival while favouring BT regarding patient satisfaction and sexual function. There might be advantages of EBRT (with/without HT) compared to cryoablation (with/without HT). No studies on HIFU were identified.
CONCLUSIONS
Based on this systematic review, there is no strong evidence to support one therapy over another as EBRT, BT and RP can all be considered as effective monotherapies for localised disease with EBRT also effective for post-operative management. All treatments have unique adverse events profiles. Further large, robust RCTs which report treatment-specific and treatment combination-specific outcomes in defined prostate cancer risk groups following established reporting standards are needed. These will strengthen the evidence base for newer technologies, help reinforce current consensus guidelines and establish greater standardisation across practices.
Topics: Antineoplastic Agents, Hormonal; Brachytherapy; Chemoradiotherapy; Chemotherapy, Adjuvant; Chi-Square Distribution; Cryosurgery; Disease Progression; Disease-Free Survival; High-Intensity Focused Ultrasound Ablation; Humans; Male; Odds Ratio; Prostatectomy; Prostatic Neoplasms; Radiotherapy Dosage; Radiotherapy, Adjuvant; Randomized Controlled Trials as Topic; Risk Factors; Survival Analysis; Time Factors; Treatment Outcome; Watchful Waiting
PubMed: 26254809
DOI: 10.1016/j.ejca.2015.07.019 -
Journal of Vascular Surgery Sep 2018The optimal catheter-directed therapy for femoropopliteal in-stent restenosis (ISR) remains controversial with limited durability. The natural history of untreated ISR...
OBJECTIVE
The optimal catheter-directed therapy for femoropopliteal in-stent restenosis (ISR) remains controversial with limited durability. The natural history of untreated ISR is not well characterized. We evaluated the midterm outcomes of patients with asymptomatic isolated femoropopliteal ISR who were observed under a surveillance program.
METHODS
Patients treated with isolated femoropopliteal stents from January 2009 to December 2013 were retrospectively investigated for the development of ISR. ISR was classified on the basis of duplex ultrasound criteria, with >50% defined as peak systolic velocity (PSV) twice that of the normal vessel and >75% as PSV >400 cm/s or four times the normal PSV. Asymptomatic patients with ISR of >50% were tracked for progression to high-grade (>75%) stenosis, occlusion, need for reintervention, and amputation.
RESULTS
Asymptomatic ISR of >50% was identified in 62 (15.3%) of 402 patients with isolated femoropopliteal stents. The mean time for development of ISR was 22.1 (±20.1) months. The mean age was 72 (±9.7) years, and 34 (55.7%) patients were female. Thirty-one (50%) patients were diabetic, 18 (29.1%) were smokers, and 8 (12.9%) had chronic kidney disease. Indications for treatment were claudication in 49 (79.0%), tissue loss in 9 (14.5%), and rest pain in 4 (6.4%) patients. TransAtlantic Inter-Society Consensus (TASC) A lesions were treated in 13 (21%) patients, TASC B lesions in 24 (38.7%), and TASC C lesions in 25 (40.3%). Three-vessel runoff was identified in 25 (40.3%) patients, two-vessel runoff in 18 (29.0%), and one-vessel runoff in 19 (30.6%). Under surveillance, ISR of >50% progressed to >75% or occlusion in 20 (32.3%) patients. The mean time to progression was 17.4 months, and the mean overall follow-up was 33.1 months. Reintervention was required in 22 (35.0%) patients, with an average of 1.95 (range, 1-4) interventions per patient. Reintervention was undertaken in 19 (86%) patients for claudication and in 3 (18%) patients for critical limb ischemia. One patient required an amputation despite previous reintervention for progression. Progression to >75% stenosis was predictive of need for reintervention (P = .004).
CONCLUSIONS
Under a surveillance program, asymptomatic patients with femoropopliteal ISR of >50% may be observed with a low risk of limb loss. Given the slow rate of progression and the poor durability of reintervention, surveillance with delayed intervention may be warranted.
Topics: Aged; Arterial Occlusive Diseases; Comorbidity; Constriction, Pathologic; Disease Progression; Female; Femoral Artery; Humans; Limb Salvage; Male; Peripheral Arterial Disease; Popliteal Artery; Recurrence; Retrospective Studies; Stents; Treatment Outcome; Ultrasonography, Doppler, Duplex; Vascular Patency; Watchful Waiting
PubMed: 30144908
DOI: 10.1016/j.jvs.2018.01.030