El dilema clinico-económico de la re-estenosis...

Transcripción

1 El dilema clinico-económico de la re-estenosis... Dr. Miguel Montero-Baker University Medical Center - Tucson, AZ Marzo 2013

2 Goodney et. al. - JVS 2009

3 Nuestro peor enemigo!

4 Nuestro peor enemigo!

5 Controversialidad filosófica de la re-estenosis

6 Controversialidad filosófica de la re-estenosis Hospital Público - NO le sirve

7 Controversialidad filosófica de la re-estenosis Hospital Público - NO le sirve Hospital Privado - Si le sirve

8 Controversialidad filosófica de la re-estenosis Hospital Público - NO le sirve Hospital Privado - Si le sirve Aserguradora privada - NO le sirve

9 Controversialidad filosófica de la re-estenosis Hospital Público - NO le sirve Hospital Privado - Si le sirve Aserguradora privada - NO le sirve Paciente - NO le sirve

10 Controversialidad filosófica de la re-estenosis Hospital Público - NO le sirve Hospital Privado - Si le sirve Aserguradora privada - NO le sirve Paciente - NO le sirve Médico -???

11 Tsuchikane et. al. - J Inv Car 2007

12 Tsuchikane et. al. - J Inv Car 2007

13 From the Western Vascular Society The role of endovascular treatment of femoropopliteal artery (SFA) angioplasty alone with nitinol stenting have Contemporary outcomes after superficial femoral artery angioplasty and stenting: The influence of TASC classification and runoff score Daniel M. Ihnat, MD, a Son T. Duong, MD, a Zachary C. Taylor, MD, a Luis R. Leon, MD, a Joseph L. Mills Sr, MD, a Kaoru R. Goshima, MD, a Jose A. Echeverri, MD, b and Bulent Arslan, MD, b Tucson, Ariz Objective: A recent randomized trial suggested nitinol self-expanding stents (SES) were associated with reduced restenosis rates compared with simple percutaneous transluminal angioplasty (PTA). We evaluated our results with superficial femoral artery (SFA) SES to determine whether TransAtlantic InterSociety Consensus (TASC) classification, indication for intervention, patient risk factors, or Society of Vascular Surgery (SVS) runoff score correlated with patency and clinical outcome, and to evaluate if bare nitinol stents or expanded polytetrafluoroethylene (eptfe) covered stent placement adversely impacts the tibial artery runoff. Methods: A total of 109 consecutive SFA stenting procedures (95 patients) at two university-affiliated hospitals from 2003 to 2006 were identified. Medical records, angiographic, and noninvasive studies were reviewed in detail. Patient demographics and risk factors were recorded. Procedural angiograms were classified according to TASC Criteria (I-2000 and II-2007 versions) and SVS runoff scores were determined in every patient; primary, primary-assisted, secondary patency, and limb salvage rates were calculated. Cox proportional hazard model was used to determine if indication, TASC classification, runoff score, and comorbidities affected outcome. Results: Seventy-one patients (65%) underwent SES for claudication and 38 patients (35%) for critical limb ischemia (CLI). Average treatment length was 15.7 cm, average runoff score was 4.6. Overall 36-month primary, primary-assisted, and secondary rates were 52%, 64%, and 59%, respectively. Limb salvage was 75% in CLI patients. No limbs were lost following interventions in claudicants (mean follow-up 16 months). In 24 patients with stent occlusion, 15 underwent endovascular revision, only five (33%) ultimately remained patent (15.8 months after reintervention). In contrast, all nine reinterventions for in-stent stenosis remained patent (17.8 months). Of 24 patients who underwent 37 endovascular revisions for either occlusion or stenosis, eight (35%) had worsening of their runoff score (4.1 to 6.4). By Cox proportional hazards analysis, hypertension (hazard ratio [HR] 0.35), TASC D lesions (HR 5.5), and runoff score > 5 (HR 2.6) significantly affected primary patency. Conclusions: Self-expanding stents produce acceptable outcomes for treatment of SFA disease. Poorer patency rates are associated with TASC D lesions and poor initial runoff score; HTN was associated with improved patency rates. Stent occlusion and in-stent stenosis were not entirely benign; one-third of patients had deterioration of their tibial artery runoff. Future studies of SFA interventions need to stratify TASC classification and runoff score. Further evaluation of the long-term effects of SFA stenting on tibial runoff is needed. ( J Vasc Surg 2008;47: )

14 to 2006 were identified. Medical records, angiographic, and noninvasive studies were reviewed in detail. Patient demographics and risk factors were recorded. Procedural angiograms were classified according to TASC Criteria (I-2000 and II-2007 versions) and SVS runoff scores were determined in every patient; primary, primary-assisted, secondary patency, and limb salvage rates were calculated. Cox proportional hazard model was used to determine if indication, TASC classification, runoff score, and comorbidities affected outcome. Results: Seventy-one patients (65%) underwent SES for claudication and 38 patients (35%) for critical limb ischemia (CLI). Average treatment length was 15.7 cm, average runoff score was 4.6. Overall 36-month primary, primary-assisted, and secondary rates were 52%, 64%, and 59%, respectively. Limb salvage was 75% in CLI patients. No limbs were lost following interventions in claudicants (mean follow-up 16 months). In 24 patients with stent occlusion, 15 underwent endovascular revision, only five (33%) ultimately remained patent (15.8 months after reintervention). In contrast, all nine reinterventions for in-stent stenosis remained patent (17.8 months). Of 24 patients who underwent 37 endovascular revisions for either occlusion or stenosis, eight (35%) had worsening of their runoff score (4.1 to 6.4). By Cox proportional hazards analysis, hypertension (hazard ratio [HR] 0.35), TASC D lesions (HR 5.5), and runoff score > 5 (HR 2.6) significantly affected primary patency. Conclusions: Self-expanding stents produce acceptable outcomes for treatment of SFA disease. Poorer patency rates are associated with TASC D lesions and poor initial runoff score; HTN was associated with improved patency rates. Stent occlusion and in-stent stenosis were not entirely benign; one-third of patients had deterioration of their tibial artery runoff. Future studies of SFA interventions need to stratify TASC classification and runoff score. Further evaluation of the long-term effects of SFA stenting on tibial runoff is needed. ( J Vasc Surg 2008;47: ) The role of endovascular treatment of femoropopliteal ry occlusive disease continues to evolve. Early experies with stainless-steel stents showed no benefit over ioplasty alone 1-5 and stenting was relegated to salvage cedure status in the face of failed angioplasty. More nt randomized studies comparing superficial femoral the Vascular Surgery a and the Interventional Radiology Sections, b niversity of Arizona Health Science Center, University Medical Center, d the Southern Arizona Veteran Affairs Health Care System. petition of interest: Dr Ihnat has received a grant from W.L. Gore & artery (SFA) angioplasty alone with nitinol stenting h shown a reduced incidence of restenosis with primary ste ing. 6,7 Others have reported 8 superior patency rates us expanded polytetrafluoroethylene (eptfe) covered st grafts (covered stents) compared with angioplasty alo In addition to angioplasty and stenting, technologi advances 9-12 continue to create new treatment mod ties. With the explosion in endovascular technology, a p adigm shift has occurred in vascular surgery. Reserv

15 TLR? De qué tengo cara???

16 TLR? De qué tengo cara??? Se podría estar perdiendo vasos de salida... y aún estar asintomático!

17 TLR? De qué tengo cara??? Se podría estar perdiendo vasos de salida... y aún estar asintomático! Un monstruo más complejo de tratar puede estar creciendo... y aún estar asintomático!

18 JACC Vol. 59, No. 1, 2012 December 27, 2011/January 3, 2012:16 23 Figure 1 Participant Flow Through the Trial and ISR Classification FP femoropopliteal; ISR in-stent restenosis. Tosaka et al. Restenotic Patterns After Femoropopliteal Stenting s o t b r ( 0 ( 0 Tosaka et al. - JACC 2012

19 ORIGINAL STENT IMPLANT 2003 Agradecimiento a Y. Khatib - CIT 2011

20 2003 PRESENT ORIGINAL STENT IMPLANT 2003 Agradecimiento a Y. Khatib - CIT 2011

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30 PROCEDIMIENTO Costo Total Meses Patencia Stent $ Stent dentro stent $ Angioplastía balón $ Angioplastía balón $ TOTAL $

31 PROCEDIMIENTO Costo Total Meses Patencia Stent $ Stent dentro stent $ Angioplastía balón $ Angioplastía balón $ TOTAL $ PROCEDIMIENTO NUMERO 1 - Introductor 5F $25 - Guía hidrofílica $75 - Catéter diagnóstico $25 - Introductor 6F crossover $150 - Balón $300 - Stent (x2) $ Costos Hospitalarios $5000

32 PROCEDIMIENTO Costo Total Meses Patencia Stent $ Stent dentro stent $ Angioplastía balón $ Angioplastía balón $ TOTAL $ PROCEDIMIENTO NUMERO 1 - Introductor 5F $25 - Guía hidrofílica $75 - Catéter diagnóstico $25 - Introductor 6F crossover $150 - Balón $300 - Stent (x2) $ Costos Hospitalarios $5000

33 PROCEDIMIENTO Costo Total Meses Patencia Stent $ Stent dentro stent $ Angioplastía balón $ Angioplastía balón $ TOTAL $ PROCEDIMIENTO NUMERO 12 - Introductor 5F $25 - Guía hidrofílica $75 - Catéter diagnóstico $25 - Introductor 6F crossover $150 - Balón $300 - Stent (x2) $ Costos Hospitalarios $5000

34 PROCEDIMIENTO Costo Total Meses Patencia Stent $ Stent dentro stent $ Angioplastía balón $ Angioplastía balón $ TOTAL $ PROCEDIMIENTO NUMERO 12 - Introductor 5F $25 - Guía hidrofílica $75 - Catéter diagnóstico $25 - Introductor 6F crossover $150 - Balón $300 - Stent (x2) $ Costos Hospitalarios $5000

35 PROCEDIMIENTO Costo Total Meses Patencia Stent $ Stent dentro stent $ Angioplastía balón $ Angioplastía balón $ TOTAL $ PROCEDIMIENTO NUMERO 12 PROCEDIMIENTO NUMERO 3 Introductor 5F $25 - Introductor 5F $25 Guía hidrofílica $75 - Guía hidrofílica $75 Catéter diagnóstico $25 - Catéter diagnóstico $25 Introductor 6F crossover $150 - Introductor 6F crossover $150 Balón $300 - Balón $300 - Stent (x2) $ Costos Hospitalarios $5000 Costos Hospitalarios $5000

36 PROCEDIMIENTO Costo Total Meses Patencia Stent $ Stent dentro stent $ Angioplastía balón $ Angioplastía balón $ TOTAL $ PROCEDIMIENTO NUMERO 12 PROCEDIMIENTO NUMERO 3 Introductor 5F $25 - Introductor 5F $25 Guía hidrofílica $75 - Guía hidrofílica $75 Catéter diagnóstico $25 - Catéter diagnóstico $25 Introductor 6F crossover $150 - Introductor 6F crossover $150 Balón $300 - Balón $300 - Stent (x2) $ Costos Hospitalarios $5000 Costos Hospitalarios $5000

37 PROCEDIMIENTO Costo Total Meses Patencia Stent $ Stent dentro stent $ Angioplastía balón $ Angioplastía balón $ TOTAL $ PROCEDIMIENTO NUMERO 12 PROCEDIMIENTO NUMERO 34 Introductor 5F $25 - Introductor 5F $25 Guía hidrofílica $75 - Guía hidrofílica $75 Catéter diagnóstico $25 - Catéter diagnóstico $25 Introductor 6F crossover $150 - Introductor 6F crossover $150 Balón $300 - Balón $300 - Stent (x2) $ Costos Hospitalarios $5000 Costos Hospitalarios $5000

38 PROCEDIMIENTO Costo Total Meses Patencia Stent $ Stent dentro stent $ Angioplastía balón $ Angioplastía balón $ TOTAL $ PROCEDIMIENTO NUMERO 12 PROCEDIMIENTO NUMERO 34 Introductor 5F $25 - Introductor 5F $25 Guía hidrofílica $75 - Guía hidrofílica $75 Catéter diagnóstico $25 - Catéter diagnóstico $25 Introductor 6F crossover $150 - Introductor 6F crossover $150 Balón $300 - Balón $300 - Stent (x2) $ Costos Hospitalarios $5000 Costos Hospitalarios $5000

39 PROCEDIMIENTO Costo Total Meses Patencia Stent $ Stent dentro stent $ Angioplastía balón $ Angioplastía balón $ TOTAL $ PROCEDIMIENTO NUMERO 12 PROCEDIMIENTO NUMERO 34 Introductor 5F $25 - Introductor 5F $25 Guía hidrofílica $75 - Guía hidrofílica $75 Catéter diagnóstico $25 - Catéter diagnóstico $25 Introductor 6F crossover $150 - Introductor 6F crossover $150 Balón $300 - Balón $300 - Stent (x2) $ Costos Hospitalarios $5000 Costos Hospitalarios $5000

40 PROCEDIMIENTO Costo Total Meses Patencia Stent $ Stent dentro stent $ Angioplastía balón $ Angioplastía balón $ TOTAL $

41 PROCEDIMIENTO Costo Total Meses Patencia Stent $ Stent dentro stent $ Angioplastía balón $ Angioplastía balón $ TOTAL $ PROCEDIMIENTO NUMERO 5 - Introductor 5F $25 - Guía hidrofílica $75 - Catéter diagnóstico $25 - Introductor 6F crossover $150 - Balón $300 - Stent (x2) $ Costos Hospitalarios $5000

42 PROCEDIMIENTO Costo Total Meses Patencia Stent $ Stent dentro stent $ Angioplastía balón $ Angioplastía balón $ TOTAL $ Zilver PTX $

43 Costo Procedimiento No. 1 $8575 Costo Procedimiento No. 1-4 $28.300

44 Costo Procedimiento No. 1 $8575 Costo Procedimiento PTX $ Costo Procedimiento No. 1-4 $28.300

45 Costo Procedimiento No. 1 $ % Costo Procedimiento PTX $ x1.3 Costo Procedimiento No. 1-4 $28.300

46 Costo Procedimiento No. 1 $ % Costo Procedimiento PTX $ x1.3 Costo Procedimiento No. 1-4 $ Costo Procedimiento PTX $11.275

47 Costo Procedimiento No. 1 $ % Costo Procedimiento PTX $ x1.3 Costo Procedimiento No. 1-4 $ % Costo Procedimiento PTX $ x2.5

48 Continuing Education This study is the first to estimate costs and medical resource use assocated with restenosis involving bare metal stents in managed care percutaneous coronary intervention patients. Clinical and Economic Effects of Coronary Restenosis After Percutaneous Coronary Intervention in a Managed Care Population MARY ANN CLARK,MHA 1 ;AMEET BAKHAI,MD 2,MRCP;ELISE M. PELLETIER,MS 3 ;DAVID J. COHEN,MD,MSC 4 1,3 Department of Health Economics and Outcomes Research, Boston Scientific Corp., Natick, Mass.; 2,4 Division of Cardiology, Beth Israel Deaconess Medical Center, Boston; 2 Clinical Trials and Evaluation Unit, Royal Brompton Hospital, London; 4 Department of Health Policy and Management, Harvard School of Public Health, Boston ABSTRACT Purpose: The epidemiology of coronary restenosis after percutaneous coronary intervention (PCI) has been documented extensively in clinical trials, but no data exist on the clinical and economic burden of restenosis in a managed care population. Methodology: Patients undergoing initial PCI between 1/1/00 and 12/31/00 (N=3,258) were identified and followed to 1 year. Clinical events, resource use, and costs between 1 month and 1 year after the initial PCI were identified. The clinical restenosis rate was estimated by multiplying the observed repeat tients and increased health care costs by an average of $3,118 per patient. These findings have important implications for the cost-effectiveness of new treatments that substantially reduce restenosis. Key terms: restenosis, stent, costeffectiveness, managed care, costs, epidemiology Clark et. al. - ManCar 2005

49 $ 1.9 billion

50 A continuous process SFA Restenosis Coronaries with DES

51 A continuous process SFA Restenosis Zilver PTX (RT) Coronaries with DES

52 A continuous process SFA Restenosis Zilver PTX (RT) Coronaries with DES

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