TAVR in patients with. End-Stage CKD or in Renal Replacement Therapy:

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1 TAVR in patients with End-Stage CKD or in Renal Replacement Therapy: Special Considerations and Prevention of early Valve Failure Antonios Chalapas, MD, PhD, FESC THV & Hygeia Hospital Heart Team Athens, Greece

2 46 year-old Male Severe Aortic valve Stenosis (AVA 0.8cm 2 ) MS moderate (MVA 1.4cm 2 ) LVEF 45% spap 60mmHg Hospitalizations over the tie due to decompensated HF and pulmonary edema Cormobidities ESRD due to Alport Syndrome in RT waiting list Restrictive lung disease (FEV1/FVC < 80%) OSAS on Bi-PAP Euro-Score 16.87% STS mortality 8.6% Decision for TAVR with balloon expandable bioprosthesis THV Hygeia Data

3 Implantation of Sapien XT 26mm THV Hygeia Data

4 46 yr Male with ESRD, severe AS, treated with TAVR (Sapien XT 26mm): Follow up THV Hygeia Data

5 CRD and Life Expectancy Nephrol Dial Transplant (2012) 27: United States Renal Data System (2015) Mortality. In: USRDS annual data report: epidemiology of kidney disease in the United States. National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, chapter 6, vol 2,

6 Temporal trends of ESRD patients undergoing s-avr and TAVR in the US between 2005 and 2014 Utilization of AVR in dialysis patients with AS increased 3-fold between 2005 and 2014 American Journal of Medicine (2017) 130,1464.e e11

7 Comparison of the progression of PG, V-max, decreasing rate of AVA Progression rate of AS (PG 12mmHg/year) was 2-3 fold greater in the CD vs. non-cd pts Circ J 2005; 69:

8 Progression of AS in ESRD Variability in the rate of AS progression Rapid Progressors Slow Progressors Circ J 2005; 69: It may be reasonable to consider ESRD patients with moderate AS to be equivalent to demonstrated rapid Progressors who warrant a yearly echocardiogram and monitoring for early symptoms (Class IIb) JACC Volume 60, Issue 5, July 2012

9 Progression of AS in ESRD Variability in the rate of AS progression WHEN MUST BE OPERATED??? Circ J 2005; 69: It may be reasonable to consider ESRD patients with moderate AS to be equivalent to demonstrated c who warrant a yearly echocardiogram and monitoring for early symptoms (Class IIb) JACC Volume 60, Issue 5, July 2012

10 3.5-fold higher mortality rate in patients who were treated with a watchful waiting strategy compared with early AVR J Am Coll Cardiol 2016;67:

11 Determinants of progression of AS in ESRD patients Journal of Cardiology (2012) 59, 78 83

12 Do Statins Slow the Progression of AS? Do Bisphosphonates Slow the Progression of AS? J Am Coll Cardiol 2012;59:1452 9

13 CURRENT AS registry Outcomes after surgery and medical treatment in Pts with severe AS J Am Heart Assoc. 2017;6:e004961

14 In-hospital Mortality in propensity-matched pts on maintenance ESRD post savr or TAVR American Journal of Medicine (2017)130,1464.e e11

15 Impact of CKD on the outcomes of TAVR FRANCE-2 registry Predictors of Mortality EuroIntervention 2015;10: e1-e9

16 Impact of CKD on the outcomes of TAVR FRANCE-2 registry Procedural patient characteristics Procedural success was significantly lower in CKD 5 ICU stay was significantly greater in CKD 5 EuroIntervention 2015;10: e1-e9

17 Comparative Outcomes of Pts With Advanced Renal Dysfunction Undergoing TAVR in the USA From 2011 to patients who underwent transcatheter aortic valve replacement between the years 2011 and 2014 Circ Cardiovasc Interv. 2017;10:e005477

18 Comparative Outcomes of Pts With Advanced Renal Dysfunction Undergoing TAVR in the USA From 2011 to 2014 Circ Cardiovasc Interv. 2017;10:e005477

19 Valve Selection for the Aortic Position in ESRD Patients J Am Heart Assoc. 2017;6:e

20 Bio-prosthetic vs. Mechanical Prostheses for AVR in ESRD patients 8,483 patients with ESRD undergoing cardiac valve replacement surgery There was no significant difference in 30-day or mid-long mortality or all-cause mortality between the two comparisons J Thorac Dis May; 8(5):

21 Valve Selection for the Aortic Position in ESRD Patients Retrospective analysis from 406 consecutive patients who underwent AVR bw 1995 and 2010 Ann Thorac Surg 2015;99:

22 Bio-prosthetic vs. Mechanical Prostheses for AVR in ESRD patients 8,483 patients with ESRD undergoing cardiac valve replacement surgery J Thorac Dis May; 8(5):

23 Major morbid events including Stroke and significant Late Bleeding in ESRD pts who have received mechanical valves requiring anticoagulation with warfarin Ann Thorac Surg 2002;74:37 42

24 Retrospective analysis of 2,010 stented bio-prosthetic AVR pts For Pts undergoing AVR with a Stented bio-prosthetic valve the choice of porcine vs. bovine pericardial prosthesis does not affect long - term Survival Ann Thorac Surg 2015;100:550 9

25 In-hospital Mortality in propensity-matched Pts on maintenance ESRD post s-avr or TAVR American Journal of Medicine (2017)130,1464.e e11

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27 TAVR is Feasible & Safe in pts with ESRD and in Renal Transplant Recipients (RTR) The access site carries a high level of risk for the transplant, since a local dissection of the pelvic vessels could lead to an impaired blood circulation. The development of AKI:I developed in 50% of the RTR. AKI was mild in 3 of 4 cases and not associated with a higher operative mortality. RTR receive immunosuppression therapy, hence, a high short-term mortality might be expected, as TAVI is associated with systemic inflammatory response syndrome, which is a strong predictor of mortality. Sci Rep Oct 31;7(1):14397

28 Worsening Renal Function Post TAVR Increases Mortality 821 patients in Partner 1 with efgr <60 ml/min was common (72%) Renal function worsened in 24% (>10% decline in GFR) Associated with almost 50% greater 1 year mortality JAMA Cardiol. Published online May 3, 2017

29 Peri-operative Factors associated with post-tavr AKI Preoperative Older age Pre-existing CKD Short-interval contrast exposure Congestive heart failure Peripheral Vascular Disease Diabetes Logistic Euro-SCORE Intraoperative Periprocedural Bleeding and Blood Transfusion Embolic events Contrast agents Hypotension from rapid ventricular pacing Transapical approach Complicated cases requiring IABP Postoperative Vasoconstricting agents Nephrotoxins Decreased heart function Hemodynamic instability Severity of AVR/PVR post TAVR J Renal Inj Prev. 2016; 5(1): 1-7.

30 Trans-Femoral TAVR in pts with ESRD and Renal Transplant Recipients (RTR) TAVR is Feasible and Safe in pts with ESRD and in RRT, who would not be considered candidates for conventional savr due to their high burden of comorbidities. Infection/Sepsis is the leading cause of Mortality Sci Rep Oct 31;7(1):14397

31 TAVR and CRD : HYGEIA Hospital Heart Team Experience 44% 25% 16% * p 0,006 ESRD No ESRD No CRD 58% 33.3% 0.8% 2,9% THV Hygeia Data

32 TAVR and CRD: HYGEIA Hospital Heart Team Experience * p 0,005 ESRD No ESRD No CRD * p 0,005 ESRD No ESRD No CRD THV Hygeia Data

33 TAVR and CRD : HYGEIA Hospital Heart Team Experience Mean Gradient AVA THV Hygeia Data

34 54 year-old Female Severe Aortic valve Stenosis V max 4.6m/s MG 51mmHg, AVA 0.6cm 2 spap 60mmHg Paroxysmal Atrial fibrillation Cormobidities ESRD due to nephrotic syndrome, on hemodialysis Rheumatoid arthritis on corticosteroids Hospitalizations over the prior 12m due to decompensated HF and pulmonary edema Euro-Score 25.6% STS mortality 14.8% Decision for TAVR with balloon expandable bioprosthes THV Hygeia Data

35 Changes in echocardiographic parameters over time THV Hygeia Data

36 Critical Stenosis of Bio-prosthetic Valve 70m post TAVR NYHA IV symptoms with rapid deterioration Decision for urgent TAVR THV Hygeia Data

37 Valve in Valve Redo TF-TAVR with Sapien-3 23mm Post hemodynamics: LV 181/12, 23 Ao 181/67mmHg Vmax 2.05m/s PG 17mmHg, MG 9mmHg DVI 0.64 THV Hygeia Data

38 Conclusion Progression rate of AS is greater in ESRD vs. non-esrd Operative timing may be too late if Peak velocity > 4 m/s Accelerated structural failure of bioprosthesis in ESRD is mainly due to various metabolic, inflammatory and CVR factors Redo TAVR (ViV) is Safe and Effective solution AS is prevalent in patients with ESRD and often pose barriers to RT

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