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1.
Artigo em Inglês | MEDLINE | ID: mdl-33722485

RESUMO

OBJECTIVE: As open abdominal aortic aneurysm (AAA) repair (OAR) rates decline in the endovascular era, the endorsement of minimum volume thresholds for OAR is increasingly controversial, as this may affect credentialing and training. The purpose of this analysis was to identify an optimal centre volume threshold that is associated with the most significant mortality reduction after OAR, and to determine how this reflects contemporary practice. METHODS: This was an observational study of OARs performed in 11 countries (2010 - 2016) within the International Consortium of Vascular Registry database (n = 178 302). The primary endpoint was post-operative in hospital mortality. Two different methodologies (area under the receiving operating curve optimisation and Markov chain Monte Carlo procedure) were used to determine the optimal centre volume threshold associated with the most significant mortality improvement. RESULTS: In total, 154 912 (86.9%) intact and 23 390 (13.1%) ruptured AAAs were analysed. The majority (63.1%; n = 112 557) underwent endovascular repair (EVAR) (OAR 36.9%; n = 65 745). A significant inverse relationship between increasing centre volume and lower peri-operative mortality after intact and ruptured OAR was evident (p < .001) but not with EVAR. An annual centre volume of between 13 and 16 procedures per year was associated with the most significant mortality reduction after intact OAR (adjusted predicted mortality < 13 procedures/year 4.6% [95% confidence interval 4.0% - 5.2%] vs. ≥ 13 procedures/year 3.1% [95% CI 2.8% - 3.5%]). With the increasing adoption of EVAR, the mean number of OARs per centre (intact + ruptured) decreased significantly (2010 - 2013 = 35.7; 2014 - 2016 = 29.8; p < .001). Only 23% of centres (n = 240/1 065) met the ≥ 13 procedures/year volume threshold, with significant variation between nations (Germany 11%; Denmark 100%). CONCLUSION: An annual centre volume of 13 - 16 OARs per year is the optimal threshold associated with the greatest mortality risk reduction after treatment of intact AAA. However, in the current endovascular era, achieving this threshold requires significant re-organisation of OAR practice delivery in many countries, and would affect provision of non-elective aortic services. Low volume centres continuing to offer OAR should aim to achieve mortality results equivalent to the high volume institution benchmark, using validated data from quality registries to track outcomes.

2.
J Urol ; 205(1): 183-190, 2021 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-32749936

RESUMO

PURPOSE: We examined long-term risks and predictors of mesh erosion and reoperation following mid urethral sling procedure for stress urinary incontinence. MATERIALS AND METHODS: Women aged 18 years or older who received a mid urethral sling for stress urinary incontinence between 2008 and 2016 in outpatient surgical settings in New York State were included in our study. Those who underwent concomitant mesh pelvic organ prolapse repair were excluded. Primary outcomes were post-implantation time to erosion and reoperations. Kaplan-Meier analysis and Cox proportional hazard models were used to assess the risks of erosion diagnosis and reoperation. RESULTS: Our cohort included 36,195 women with a mean±SD age of 53.7±12.4 years. Estimated risks of erosions and reoperations at 7 years after sling procedures were 3.7% and 6.7%, respectively. Older age (≥65 vs <65: HR 0.83, 95% CI 0.70-0.99) and high volume facilities (high vs low: HR 0.79, 95% CI 0.68-0.92) were associated with a lower risk of erosion. History of hysterectomy was associated with a higher risk of erosion (HR 1.62, 95% CI 1.36-1.92). Predictors of reoperation included concurrent abdominal or native tissue transvaginal prolapse repair, previous hysterectomy and depression. CONCLUSIONS: One in 27 women had sling erosions and 1 in 15 had invasive reoperations at 7 years after sling procedures. The highest erosion cases were observed among younger White women treated at low volume facilities. Continued and vigilant surveillance of mesh in stress urinary incontinence repairs, the nature and burden of stress urinary incontinence recurrence, different types of re-treatment, patient reported outcomes and information about treating surgeons are crucial.


Assuntos
Prolapso de Órgão Pélvico/cirurgia , Complicações Pós-Operatórias/epidemiologia , Slings Suburetrais/efeitos adversos , Telas Cirúrgicas/efeitos adversos , Incontinência Urinária por Estresse/cirurgia , Adulto , Idoso , Estudos de Coortes , Remoção de Dispositivo/estatística & dados numéricos , Feminino , Seguimentos , Humanos , Pessoa de Meia-Idade , New York/epidemiologia , Prolapso de Órgão Pélvico/complicações , Complicações Pós-Operatórias/etiologia , Estudos Prospectivos , Recidiva , Reoperação/estatística & dados numéricos , Fatores de Tempo , Resultado do Tratamento , Incontinência Urinária por Estresse/etiologia
4.
J Urol ; : 101097JU0000000000001401, 2020 Oct 07.
Artigo em Inglês | MEDLINE | ID: mdl-33026907

RESUMO

PURPOSE: To compare outcomes of transurethral prostatectomy and laser prostatectomy in the real-world setting. MATERIALS AND METHODS: We present a prospectively collected observational cohort study of 85,682 men with benign prostatic enlargement in New York State and California who received transurethral prostatectomy or laser prostatectomy in outpatient and ambulatory surgery settings from January 2005 to December 2016. We used propensity score matching to adjust for differences in patient characteristics between groups. We analyzed short-term outcomes using mixed-effect logistic regressions and long-term outcomes using Cox regressions with a time-dependent treatment variable to account for non-proportionality. We performed a sensitivity analysis using multivariable regression models. RESULTS: Patients were aged 70.5±9.7 years (mean±SD), 71% were white race with a median follow-up period of 3.8 (interquartile range 1.8-6.3) years. Transurethral prostatectomy recipients had increased risk of 30-day hospital readmission/emergency room visit (odds ratio 1.09, 95% confidence interval 1.04-1.13, p <0.001) and decreased risk of reoperation (hazard ratio 0.81, 95% confidence interval 0.76-0.88, p <0.001). Transurethral prostatectomy had higher rate of urethral stricture (hazard ratio 1.47, 95% confidence interval 1.22-1.75, p <0.001). CONCLUSIONS: Transurethral prostatectomy was associated with higher risk of short- and long-term complications, but a lower rate of long-term reoperation than laser prostatectomy for benign prostatic enlargement.

5.
J Vasc Surg ; 2020 Oct 17.
Artigo em Inglês | MEDLINE | ID: mdl-33080324

RESUMO

BACKGROUND: The Superficial Femoral Artery-Popliteal EvidencE Development (SPEED) Study Group developed contemporary objective performance goals (OPG) for peripheral vascular interventions (PVI) for superficial femoral (SFA)-popliteal artery disease utilizing the Registry Assessment of Peripheral Interventional Devices (RAPID). METHODS: The Society for Vascular Surgery (SVS) Vascular Quality Initiative (VQI) PVI Registry from January 2010-October 2016 was used to develop OPGs based on SFA-popliteal procedures (N= 21, 377) for claudication (IC) and critical limb ischemia (CLI). OPGs included one-year rates for target lesion revascularization (TLR), major amputation, and one and four-year survival. OPGs were calculated for the SFA and popliteal arteries and stratified by four treatments: angioplasty alone (PTA), self-expanding stenting, atherectomy, and any treatment type.. Outcomes were illustrated by unadjusted Kaplan-Meier analyses. RESULTS: Cohorts included PTA (N= 7,505), stenting (N= 9,217), atherectomy (N= 2,510) and any treatment (N= 21,377). The mean age was 69 years, 58% were male, 79% were white and 52% had CLI. The freedom from TLR OPGs at one year in the SFA were 80.3% (PTA), 83.2% (stenting), 83.9% (atherectomy), and 81.9% (any treatments). The freedom from TLR OPGs at one year in the popliteal were 81.3% (PTA), 81.3% (stenting), 80.2% (atherectomy), and 81.1% (any treatments). The freedom from major amputation OPGs at one year after SFA PVI were 93.4% (PTA), 95.7% (stenting), 95.1% (atherectomy), and 94.8%, (any treatments). The freedom from major amputation OPG at one year after popliteal PVI were 90.5% (PTA), 93.7% (stenting), 91.8% (atherectomy), and 91.8%, (any treatments). Four-year survival OPGs after SFA PVI were 76% (PTA), 80% (stenting), 82% (atherectomy), and 79% (any treatments) and for the popliteal artery were 72% (PTA), 77% (stenting), 82% (atherectomy), and 75% (any treatment). In multivariable analysis, which included patient level, leg level and lesion level covariates, CLI was the single independent factor associated with increased TLR, amputation and mortality. CONCLUSIONS: The SPEED OPGs define a new, contemporary benchmark for SFA-popliteal interventions utilizing a large subset of real-world evidence to inform more efficient peripheral device clinical trial designs to support regulatory and clinical decision making. It is appropriate to discuss proposals intended for regulatory approval with the FDA to refine the OPG to match the specific trial population. The OPGs may be updated using coordinated registry networks to assess long-term real-world device performance.

6.
World J Urol ; 2020 Sep 09.
Artigo em Inglês | MEDLINE | ID: mdl-32909172

RESUMO

PURPOSE: To identify clinical and non-clinical predictors of treatment failure and perioperative complications following ureterorenoscopy versus shockwave lithotripsy. METHODS: The New York State Department of Health Statewide Planning and Research Cooperative System (SPARCS) database was used to identify 226,331 patients who underwent index ureteroscopy or shockwave lithotripsy for renal stones from 2000 to 2016. Propensity-matched generalized linear-mixed modeling was utilized to compare failure and complication rates between the two procedure groups. RESULTS: 219,383 individuals meeting inclusion criteria who underwent either ureterorenoscopy (n = 124,342) or shockwave lithotripsy (n = 95,041) in New York State between 2000 and 2016 were included in our analysis. After propensity score matching, patients undergoing shockwave lithotripsy were found to have decreased odds of experiencing any type of 30-day complication (P < 0.001 for all) but increased odds of treatment failure at both 90 (OR 1.70, 95% CI 1.64-1.77) and 180 (OR 1.83, 95% CI 1.76-1.89) days (P < 0.001 for both). CONCLUSION: Patients undergoing shockwave lithotripsy experienced significantly higher odds of treatment failure, although this undesirable outcome appears to be partially offset by lower 30-day complication rates.

7.
J Gastrointest Surg ; 2020 Sep 16.
Artigo em Inglês | MEDLINE | ID: mdl-32939622

RESUMO

BACKGROUND: There is controversy surrounding the efficacy and safety of colonic stents as a bridge to surgery compared with immediate resection in patients presenting with an acute malignant large bowel obstruction. METHODS: Retrospective longitudinal cohort study using the NYS SPARCS Database. Patients with acute malignant large bowel obstruction who either had stent followed by elective surgery within 3 weeks (bridge to surgery) or underwent immediate resection between October 2009 and June 2016 in the state of New York were included. The primary outcome was rate of stoma creation at index resection. Secondary outcomes were 90-day readmission, reoperation, procedural complications, and discharge disposition. RESULTS: A total of 3059 patients were included, n = 2917 (95.4%) underwent an immediate resection and n = 142 (4.6%) underwent bridge to surgery. We analyzed 139 patients in propensity score-matched groups. Patients in the bridge to surgery group were less likely than those in the immediate resection group to get a stoma at the time of surgery (OR 0.33, 95% CI 0.18-0.60). They were also less likely to be discharged to a rehabilitation facility or require a home health aide upon discharge (OR 0.36, 95% CI 0.22-0.61). There were no differences in rates of 90-day readmission, reoperation, or procedural complications between groups. DISCUSSION: Colonic stenting as a bridge to surgery leads to less stoma creation, a significant quality of life advantage, compared with immediate resection. Patients should be counseled regarding these potential benefits when the technology is available.

8.
Eur J Vasc Endovasc Surg ; 60(4): 549-558, 2020 10.
Artigo em Inglês | MEDLINE | ID: mdl-32807674

RESUMO

OBJECTIVE: Endovascular revascularisation has become a standard approach for below knee lesions and paclitaxel coated devices have been widely used in patients with chronic limb threatening ischaemia. A recent meta-analysis reported higher mortality in paclitaxel coated devices compared with uncoated devices in femoropopliteal lesions. This study aimed to determine long term outcomes in below the knee interventions using paclitaxel coated devices in routine vascular care using a large and contemporary cohort. METHODS: A large cohort was created using all inclusive health insurance claims data of patients covered by the second largest insurance fund in Germany. The cohort included patients with index revascularisation of arteries below the knee performed from 1 January 2010, to 31 December 2018. Only patients with first paclitaxel coated device exposure were included. The study cohort was stratified into balloon vs. stent treatment and patients with paclitaxel coated devices were matched with uncoated devices using propensity score. Outcomes were evaluated using the Kaplan-Meier method and Cox regression. RESULTS: There were 14 738 patients (mean age 77.6 years, 43.6% female) and 6 568 matched patients included in the study. Increasing use of paclitaxel coated devices was observed during the study period (6% in 2010 vs. 31% in 2018, p < .001), and a total of 2 611 (39.8%) deaths occurred within five years of follow up. In the propensity score matched Cox model, a paclitaxel related reduction of five year mortality (hazards ratio, HR 0.84, 95% confidence interval, CI 0.78-0.91), amputation or death (HR 0.87, 95% CI 0.81-0.94), and cardiovascular event or death (HR 0.86, 95% CI 0.80-0.92) were observed. CONCLUSION: In this propensity score matched cohort, reduced long term all cause mortality, reduced rates of amputation or death and cardiovascular event or death were observed at five years after the use of paclitaxel coated devices when compared with uncoated devices for the treatment of chronic limb threatening ischaemia.


Assuntos
Fármacos Cardiovasculares/administração & dosagem , Materiais Revestidos Biocompatíveis , Stents Farmacológicos , Procedimentos Endovasculares/instrumentação , Isquemia/terapia , Perna (Membro)/irrigação sanguínea , Paclitaxel/administração & dosagem , Doença Arterial Periférica/terapia , Demandas Administrativas em Assistência à Saúde , Idoso , Idoso de 80 Anos ou mais , Amputação , Fármacos Cardiovasculares/efeitos adversos , Doença Crônica , Bases de Dados Factuais , Procedimentos Endovasculares/efeitos adversos , Procedimentos Endovasculares/mortalidade , Feminino , Alemanha , Humanos , Isquemia/diagnóstico por imagem , Isquemia/mortalidade , Isquemia/fisiopatologia , Salvamento de Membro , Masculino , Paclitaxel/efeitos adversos , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/mortalidade , Doença Arterial Periférica/fisiopatologia , Pontuação de Propensão , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento
9.
Ann Thorac Surg ; 2020 Aug 12.
Artigo em Inglês | MEDLINE | ID: mdl-32795521

RESUMO

BACKGROUND: Operator characteristics and outcome relationships have not been evaluated at the individual operator level. METHODS: From New York State Department of Health Statewide Planning and Research Cooperative System, 5896 elective transfemoral transcatheter aortic valve replacement (TAVR) procedures performed by 161 operators between 2012 and 2016 were analyzed. We examined the following characteristics of the primary operator: specialty (surgery vs cardiology), sex, medical school location, experience of cardiology practice, interventional cardiology credentialing, past-year TAVR volume, and first year performing TAVR in New York State. The primary outcome was a composite of inhospital mortality, stroke, and acute myocardial infarction. RESULTS: After adjusting for patient and other provider characteristics, there was no significant difference in the risk of major events between surgeons and cardiologists in performing TAVR (3.4% vs 3.6%, P = .60), between male operators and female operators (P = .80), and between operators who graduated from a US medical school and operators educated outside the United States (3.4% vs 3.6%, P = .73). In the subgroup analysis, interventional cardiology credentialing was not significantly associated with the inhospital major events (odds ratio 1.03; 95% confidence interval, 0.56 to 1.88; P = .80). CONCLUSIONS: Primary operator specialty and other characteristics for TAVR were not associated with a difference in risk-adjusted inhospital outcomes. That may be due to the heart team model that allows proceduralists of different backgrounds to lend their expertise to the procedure.

11.
Ann Surg ; 2020 Jul 07.
Artigo em Inglês | MEDLINE | ID: mdl-32649459

RESUMO

OBJECTIVE: The aim of this study was to define reporting standards for IDEAL format studies. BACKGROUND: The IDEAL Framework and Recommendations establish an integrated pathway for evaluation of new surgical techniques and complex therapeutic technologies. However guidance on implementation has been incomplete, and incorrect use is commonly seen. We describe the consensus development of reporting guidelines for the IDEAL stages, and plans for their dissemination and evaluation. METHODS: Using the EQUATOR Network recommendations, participants with knowledge of IDEAL were surveyed to determine which IDEAL stages needed reporting guidelines. Draft checklists for stages 1, 2a, 2b, and 4 were subsequently developed by 3 researchers (N.B., A.H., P.M.), and revised through a 2-round Delphi consensus process. A final consensus teleconference resolved outstanding disagreements and clarified wording for checklist items. RESULTS: Sixty-one participants completed the initial survey, a clear majority indicating that new reporting guidelines were needed for IDEAL Stage 1 (69.5%), Stage 2a (78%), Stage 2b (74.6%), and Stage 4 (66%). A proposed set of checklists was modified by survey participants in 2 online Delphi rounds (n = 54 and n = 47, respectively), resulting in a penultimate checklist for each stage. Fourteen expert working group members finalized the checklist items and successfully resolved any outstanding areas without agreement on a consensus call. CONCLUSIONS: Participants familiar with IDEAL called for reporting guidelines for studies in all IDEAL stages except stage 3. The checklists developed have the potential to improve standards of reporting and thereby advance the quality of research on surgery and complex interventions and technologies, but require further evaluation in use.

12.
Eur J Vasc Endovasc Surg ; 60(3): 421-429, 2020 09.
Artigo em Inglês | MEDLINE | ID: mdl-32669223

RESUMO

OBJECTIVE: Optimal pharmacological treatment (OPT) for peripheral arterial occlusive disease (PAOD) includes prescription of lipid lowering drugs, antithrombotics, and antihypertensives to symptomatic patients affected by intermittent claudication or chronic limb threatening ischaemia. This study sought to determine sex disparities and time trends in prescription of OPT in this population (clinicaltrials.gov NCT03909022). METHODS: Using data from the second largest insurance fund in Germany, BARMER, data on patients with an index admission for symptomatic PAOD between 1 January 2010 and 30 June 2018 with follow up until the end of 2018 were analysed. Sex disparities in post-discharge prescription status six months after index admission were tested and adjusted for patient and healthcare variables using bivariable tests and logistic regression analysis. Time trends in the prescription prevalence of OPT were analysed and tested. RESULTS: There were 83 867 patients (mean age 71.9 years and 45.8% women) eligible for inclusion in the study. When compared with men, women had lower rates of prior outpatient care for PAOD (39.8% vs. 47.0%), were admitted more often with ischaemic rest pain (13.9% vs. 10.4%) and were older (74 vs. 70 y). After discharge, women had a lower rate of prescriptions for lipid lowering drugs (52.4% vs. 59.9%), while they received antihypertensive drugs more often (86.7% vs. 84.1%). We found evidence for a lower prescription prevalence of OPT in females (37.0% vs. 42.7%). Differences in patient and healthcare variables (e.g. demographics, comorbidities, prior treatment) between women and men explained 56% of this gap. The sex prescription gap did not narrow over time despite an overall upward trend in prescription prevalence for both women and men. CONCLUSION: Although presenting older and with more severe symptoms at the index admission for PAOD, women have a lower prescription prevalence of OPT compared with men, particularly with respect to lipid lowering drugs.


Assuntos
Demandas Administrativas em Assistência à Saúde , Anti-Hipertensivos/uso terapêutico , Fibrinolíticos/uso terapêutico , Disparidades nos Níveis de Saúde , Disparidades em Assistência à Saúde/tendências , Hipolipemiantes/uso terapêutico , Doença Arterial Periférica/tratamento farmacológico , Padrões de Prática Médica/tendências , Adulto , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Bases de Dados Factuais , Prescrições de Medicamentos , Uso de Medicamentos/tendências , Feminino , Alemanha/epidemiologia , Humanos , Masculino , Pessoa de Meia-Idade , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/epidemiologia , Estudos Retrospectivos , Medição de Risco , Índice de Gravidade de Doença , Fatores Sexuais , Fatores de Tempo , Resultado do Tratamento
13.
JAMA ; 324(2): 179-187, 2020 07 14.
Artigo em Inglês | MEDLINE | ID: mdl-32662861

RESUMO

Importance: Observational studies have suggested that the use of radial artery grafts for coronary artery bypass grafting may improve clinical outcomes compared with the use of saphenous vein grafts, but this has not been confirmed in randomized trials. Objective: To compare clinical outcomes between patients receiving radial artery vs saphenous vein grafts for coronary artery bypass grafting after long-term follow-up. Design, Setting, and Participants: Patient-level pooled analysis comparing radial artery vs saphenous vein graft in adult patients undergoing isolated coronary artery bypass grafting from 5 countries (Australia, Italy, Serbia, South Korea, and the United Kingdom), with enrollment from 1997 to 2009 and follow-up completed in 2019. Interventions: Patients were randomized to undergo either radial artery (n = 534) or saphenous vein (n = 502) grafts for coronary artery bypass grafting. Main Outcomes and Measures: The primary outcome was a composite of death, myocardial infarction, or repeat revascularization and the secondary outcome was a composite of death or myocardial infarction. Results: A total of 1036 patients were randomized (mean age, 66.6 years in the radial artery group vs 67.1 years in the saphenous vein group; 376 [70.4%] men in the radial artery group vs 351 [69.9%] in the saphenous vein group); 942 (90.9%) of the originally randomized patients completed 10 years of follow-up (510 in the radial artery group). At a median (interquartile range) follow-up of 10 (10-11) years, the use of the radial artery, compared with the saphenous vein, in coronary artery bypass grafting was associated with a statistically significant reduction in the incidence of the composite outcome of death, myocardial infarction, or repeat revascularization (220 vs 237 total events; 41 vs 47 events per 1000 patient-years; hazard ratio, 0.73 [95% CI, 0.61-0.88]; P < .001) and of the composite of death or myocardial infarction (188 vs 193 total events; 35 vs 38 events per 1000 patient-years; hazard ratio, 0.77 [95% CI, 0.63-0.94]; P = .01). Conclusions and Relevance: In this individual participant data meta-analysis with a median follow-up of 10 years, among patients undergoing coronary artery bypass grafting, the use of the radial artery compared with the saphenous vein was associated with a lower risk of a composite of cardiovascular outcomes.


Assuntos
Ponte de Artéria Coronária/métodos , Artéria Radial/transplante , Veia Safena/transplante , Idoso , Ponte de Artéria Coronária/mortalidade , Feminino , Seguimentos , Humanos , Incidência , Masculino , Infarto do Miocárdio/epidemiologia , Complicações Pós-Operatórias/epidemiologia , Ensaios Clínicos Controlados Aleatórios como Assunto , Reoperação/estatística & dados numéricos , Fatores de Tempo , Resultado do Tratamento
14.
Ann Thorac Surg ; 2020 Jun 26.
Artigo em Inglês | MEDLINE | ID: mdl-32599046

RESUMO

BACKGROUND: Bilateral internal thoracic arteries (BITA) coronary bypass grafting may improve long term outcomes but is associated with increased deep sternal wound infections (DSWI). We analyzed whether BITA skeletonization impacts DSWI and operative mortality (OM) using the Society of Thoracic Surgeons Adult Cardiac Surgery Database (STS-ACSD). METHODS: Primary, isolated, non-emergent/non-salvage BITA patients (July 2017-December 2018) in STS-ACSD were divided into groups based on BITA harvesting technique: both skeletonized (ssBITA), at least one non-skeletonized (Non-ssBITA). DSWI and OM Observed-to-Expected (O/E) ratios were compared using the STS Peri-operative Risk Models. ssBITA versus Non-ssBITA DSWI and OM Adjusted Odds Ratio (AOR) were calculated by multivariable logistic regression and corroborated by propensity score matching. RESULTS: 11,269 patients (42.8%-ssBITA, 57.2%-Non-ssBITA, 770 hospitals, 1,448 surgeons) were analyzed. The ssBITA group had a higher incidence of comorbidities and off-pump surgery. Overall incidence of DSWI and OM was 0.98%(O/E-5.1) and 1.72%(O/E-1.4), respectively and was 28%(p=0.129) and 23%(p=0.096) lower in ssBITA. The DSWI O/E was highest (5.9) in Non-ssBITA and lowest in ss-BITA (4.1). After multivariable adjustment, ssBITA was associated with a decreased risk of DSWI [AOR(95%CI)=0.66(0.44-1.00),p=0.05], with no difference in OM. These results were confirmed among 3884 propensity score matched pairs. DSWI increased sharply with increasing number of risk factors for DSWI regardless of harvesting technique with a trend for higher DSWI among Non-ssBITA for all risk categories. CONCLUSIONS: The observed high O/E indicates that BITA grafting is associated with increased risk of DSWI. Risk adjusted DSWI rate and lower O/E in ssBITA support protective role of skeletonization.

15.
J Vasc Surg ; 72(6): 2153-2160, 2020 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-32442604

RESUMO

The Vascular Implant Surveillance and Interventional Outcomes Network (VISION) is a Coordinated Registry Network (CRN) a member of Medical Device Epidemiology Network, a U.S. Food and Drug Administration (FDA)-supported global public-private partnership that seeks to advance the collection and use of real-world data to improve patient outcomes. The VISION CRN began in September 2015 and held its first strategic meeting on September 10, 2018, at the FDA headquarters in Silver Spring, Maryland. VISION is a collaboration of the Vascular Quality Initiative (VQI), the FDA, and other stakeholders. At this annual meeting, leaders from the FDA, VQI, industry representatives, population health researchers, and regulatory science experts gathered to discuss strategic goals and opportunities for VISION. One of the key focus areas for VISION is linkage of VQI registry data to Medicare, longitudinal data sources maintained by various states, and other relevant data sources, as a model for efficient, cost-saving, and effectual evidence generation and appraisal. This would provide the means to expand data collection, assess long-term procedural outcomes across the carotid, lower extremity, aortic, and venous intervention datasets, and execute registry-based trials through the CRN structure in an efficient, cost-effective manner. Looking forward, VISION strives to validate long-term outcome data in the VQI using industry datasets, in hopes of using CRNs to make device regulatory decisions. With the guidance of a steering committee, VISION will provide vascular surgeons, industry, and regulators the appropriate data to improve care for patients with vascular disease.

16.
Artigo em Inglês | MEDLINE | ID: mdl-32453208

RESUMO

OBJECTIVE: This study was to examine the impact of the July 2011 Food and Drug Administration (FDA) safety communication on the use of transvaginal mesh in pelvic organ prolapse (POP) repair by patients' race and ethnicity. METHODS: We conducted an observational cohort study of women undergoing POP repairs in 2008 to 2015 in New York State. We examined the changes in transvaginal mesh use in POP repairs before and after the FDA communication by patients' race and ethnicity. Piecewise logistic regression models were used to assess the trends of mesh use, adjusting for patient characteristics. We performed a subgroup analysis of the trends of transvaginal mesh use by racial groups, stratifying by patients' neighborhood socioeconomic status. RESULTS: We included 49,848 women (78% white, 7% black, and 15% Hispanic) with an average ± SD age of 60.2 ± 13.0 years. After the safety communication, the use of transvaginal mesh in POP repairs decreased among white women (odds ratio [OR], 0.45; 95% confidence interval [CI], 0.41-0.50) and African Americans (OR, 0.48; 95% CI, 0.35-0.67) but remained stable among Hispanic women (OR, 0.88; 95% CI, 0.70-1.11). Only in the subgroup of patients from high-income areas, there was a trend toward decreasing mesh use among Hispanic patients after 2011 (OR, 0.71; 95% CI, 0.49-1.04). CONCLUSIONS: The communications related to the safety of transvaginal mesh did not have an equal impact across racial groups. Mesh use decreased among white and African American women but not among Hispanic women after the 2011 FDA safety communication. Particular attention is warranted for patients from disadvantaged groups, especially low-income minorities, when disseminating medical device safety messages.

17.
Cancer ; 126(13): 2986-2990, 2020 Jul 01.
Artigo em Inglês | MEDLINE | ID: mdl-32320063

RESUMO

BACKGROUND: Adoption of prostate magnetic resonance imaging (MRI) before biopsy is based on evidence demonstrating superior detection of clinically significant prostate cancer on biopsy. Whether this is due to the detection of otherwise occult higher grade cancers or preferential sampling of higher grade areas within an otherwise low-grade cancer is unknown. METHODS: To distinguish these two possibilities, this study examined the effect of prebiopsy MRI on the rate of pathologic upgrading and downgrading at prostatectomy in Surveillance, Epidemiology, and End Results-Medicare linked data from 2010 to 2015. Logistic regression was performed to assess the effect of MRI use on the Gleason grade change between biopsy and prostatectomy. RESULTS: Among biopsy-naive men, those who underwent prebiopsy MRI had higher odds of downgrading at prostatectomy (odds ratio [OR], 1.32; 95% confidence interval [CI], 1.05-1.66). In contrast, the odds of upgrading were significantly lower for men who underwent prebiopsy MRI (OR, 0.78; 95% CI, 0.61-0.99). Limitations included a low overall rate of MRI-utilization prior to biopsy and an inability to distinguish between template, software-assisted and cognitive fusion biopsy. CONCLUSIONS: Prebiopsy MRI is associated with both oversampling of higher grade areas, which results in downgrading at prostatectomy, and the detection of otherwise occult higher grade lesions, which results in less upgrading at prostatectomy.

20.
J Am Heart Assoc ; 9(4): e013606, 2020 02 18.
Artigo em Inglês | MEDLINE | ID: mdl-32063087

RESUMO

Background More than 600 000 coronary stents are implanted during percutaneous coronary interventions (PCIs) annually in the United States. Because no real-world surveillance system exists to monitor their long-term safety, claims data are often used for this purpose. The extent to which adverse events identified with claims data can be reasonably attributed to a specific medical device is uncertain. Methods and Results We used deterministic matching to link the NCDR (National Cardiovascular Data Registry) CathPCI Registry to Medicare fee-for-service claims for patients aged ≥65 years who underwent PCI with drug-eluting stents (DESs) between July 1, 2009 and December 31, 2013. We identified subsequent PCIs within 1 year of the index procedure in Medicare claims as potential safety events. We linked these subsequent PCIs back to the NCDR CathPCI Registry to ascertain how often the revascularization could be reasonably attributed to the same coronary artery as the index PCI (ie, target vessel revascularization). Of 415 306 DES placements in 368 194 patients, 33 174 repeat PCIs were identified in Medicare claims within 1 year. Of these, 28 632 (86.3%) could be linked back to the NCDR CathPCI Registry; 16 942 (51.1% of repeat PCIs) were target vessel revascularizations. Of these, 8544 (50.4%) were within a previously placed DES: 7652 for in-stent restenosis and 1341 for stent thrombosis. Of 16 176 patients with a claim for acute myocardial infarction in the follow-up period, 4446 (27.5%) were attributed to the same coronary artery in which the DES was implanted during the index PCI (ie, target vessel myocardial infarction). Of 24 288 patients whose death was identified in claims data, 278 (1.1%) were attributed to the same coronary artery in which the DES was implanted during the index PCI. Conclusions Most repeat PCIs following DES stent implantation identified in longitudinal claims data could be linked to real-world registry data, but only half could be reasonably attributed to the same coronary artery as the index procedure. Attribution among those with acute myocardial infarction or who died was even less frequent. Safety signals identified using claims data alone will require more in-depth examination to accurately assess stent safety.

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