Successfully reported this slideshow.
We use your LinkedIn profile and activity data to personalize ads and to show you more relevant ads. You can change your ad preferences anytime.
Lo mejor del Congreso ACC Orlando 2018
LO MEJOR EN INSUFICIENCIA
CARDIACA
JOSÉ MANUEL GARCÍA PINILLA
UNIDAD DE INSUFICIENC...
Lo mejor del Congreso ACC Orlando 2018 23
Lo mejor del Congreso ACC Orlando 2018
Study Design
.
Short Term (ST) Cohort1
N=294
6-month follow-up
Randomization
1:1
Pa...
Lo mejor del Congreso ACC Orlando 2018
Primary Endpoint Component 1
Overall Survival
No. at Risk
HeartMate 3
HeartMate II
...
Lo mejor del Congreso ACC Orlando 2018
Lo mejor del Congreso ACC Orlando 2018
Lo mejor del Congreso ACC Orlando 2018
Subgroup Analyses of the Primary Endpoint (ITT)
denotes bridge to transplant; BTC, ...
Lo mejor del Congreso ACC Orlando 2018
CONCLUSIONES
• HM3 fue clínicamente superior a HM2 en el
seguimiento a largo plazo ...
Lo mejor del Congreso ACC Orlando 2018
Barry A. Borlaug
On behalf of the
NHLBI Heart Failure Clinical Research Network
A R...
Lo mejor del Congreso ACC Orlando 2018
Hypothesis
• As compared to placebo, 4 weeks treatment with
inhaled, nebulized inor...
Lo mejor del Congreso ACC Orlando 2018
Study Design: Randomized, double-blind,
placebo-controlled crossover study
Nitrite ...
Lo mejor del Congreso ACC Orlando 2018
INDIE Primary End-point
• Peak oxygen consumption (Peak VO2) during
cardiopulmonary...
Lo mejor del Congreso ACC Orlando 2018
Carvedilol for PrEvention of Chemotherapy-Induced CardiotoxicitY
Results of the Pro...
Lo mejor del Congreso ACC Orlando 2018
CECCY Trial
Anthracycline Infusion
3 weeks 3 weeks3 weeks3 weeks
Weekly Taxane Infu...
Lo mejor del Congreso ACC Orlando 2018
n= 96 + 96
Lo mejor del Congreso ACC Orlando 2018
CECCY Trial
14%
86%
Placebo
no.pts withdecreaseofLVEF≥ 10%
no. pts with decrease of...
Lo mejor del Congreso ACC Orlando 2018
Percentage of patients at the different dose
ranges of carvedilol or placebo.
Dose ...
Lo mejor del Congreso ACC Orlando 2018
Seguimiento corto (sólo 6 meses)
Estudio monocéntrico
La incidencia de cardiotoxici...
Lo mejor del Congreso ACC Orlando 2018
Lisinopril or Carvedilol for Prevention of
Trastuzumab Induced Cardiotoxicity
Lo mejor del Congreso ACC Orlando 2018
Definition of Cardiotoxicity
• LVEFdecreasefrom thebaselineof≥10%
or
• LVEFdecrease...
Lo mejor del Congreso ACC Orlando 2018
2 años de seguimiento (1 en tratamiento con trastuzumab)
Lo mejor del Congreso ACC Orlando 2018
Cardiotoxicity-free survival for the cohort with
Trastuzumab + Anthracycline
Probab...
Lo mejor del Congreso ACC Orlando 2018
Presenter: Ambarish Pandey
UT Southwestern Center Dallas, TX
Hospital Performance B...
Lo mejor del Congreso ACC Orlando 2018
Long-term Outcomes
Q1
High Performing
Q2 Q3
Q4
Low Performing
Overall Population
Me...
Lo mejor del Congreso ACC Orlando 2018
Ferric Iron in Heart Failure (FERRIC-HF) II
Randomized Controlled Trial of the Effe...
Lo mejor del Congreso ACC Orlando 2018
Lo mejor del Congreso ACC Orlando 2018
Lo mejor del Congreso ACC Orlando 2018
Lower MortalityandHeart FailureHospitalizationFollowing
Implant of anAmbulatoryHemo...
Lo mejor del Congreso ACC Orlando 2018
Lower MortalityandHeart FailureHospitalizationFollowing
Implant of anAmbulatoryHemo...
Lo mejor del Congreso ACC Orlando 2018
Temporal Matching
Implant
0 12mo-12mo
Clinical
match
Clinical Matching
N=1176
1. Ge...
Lo mejor del Congreso ACC Orlando 2018
784
616
0
200
400
600
800
HFH
Control Cohort Treatment Cohort
HFHospitalization: Po...
Lo mejor del Congreso ACC Orlando 2018
HF hospitalization Mortality
El implante de un sensor de TA se asoció a una
reducci...
Lo mejor del Congreso ACC Orlando 2018
Josep Rodés-Cabau, MD, FACC
Quebec Heart & Lung Institute, Laval University
on beha...
Lo mejor del Congreso ACC Orlando 2018
• Procedures/Follow-Up
– Transfemoral venous
approach, general anesthesia,
TEE guid...
Lo mejor del Congreso ACC Orlando 2018
Outcomes
/38
NE at 3M
Patients (n=38)
PROCEDURAL/IN-HOSPITAL
Successful device impl...
Lo mejor del Congreso ACC Orlando 2018
Functional,EchoandHemodynamicParameters
Variable
Baseline
(n=38)
3 Months
(n=36)
12...
Lo mejor del Congreso ACC Orlando 2018
Shunt ValveFunctionat 1-3and12Months(TEE)
A. Widely Patent Shunt B. Stenotic Shunt;...
Lo mejor del Congreso ACC Orlando 2018
HemodynamicChangesGroupedbyShunt Patencyat 1-Year Follow-Up
Patent ≥ Stenotic/Occlu...
Lo mejor del Congreso ACC Orlando 2018
ComparisonwithCMEMsChampionStudy
Studies had similar:
• eligibility criteria
• base...
Lo mejor del Congreso ACC Orlando 2018
• El shunt interauricular con el dispositivo V-Wave es
seguro y parece relacionarse...
Upcoming SlideShare
Loading in …5
×

Lo mejor en insuficiencia cardiaca

417 views

Published on

Presentación realizada por el Dr. José Manuel García Pinilla en el directo online ‘Lo mejor del Congreso ACC Orlando 2018’, celebrado en la SEC el 13 de marzo de 2018

Published in: Health & Medicine
  • The Kidney Disease Solution EBOOK Download Link ♣♣♣ http://scamcb.com/empoweredh/pdf
       Reply 
    Are you sure you want to  Yes  No
    Your message goes here
  • Be the first to like this

Lo mejor en insuficiencia cardiaca

  1. 1. Lo mejor del Congreso ACC Orlando 2018 LO MEJOR EN INSUFICIENCIA CARDIACA JOSÉ MANUEL GARCÍA PINILLA UNIDAD DE INSUFICIENCIA CARDIACA Y CARDIOPATÍAS FAMILIARES A.G.C. DE CARDIOLOGÍA Y CIRUGÍA CARDIOVASCULAR H. UNIVERSITARIO VIRGEN DE LA VICTORIA MÁLAGA
  2. 2. Lo mejor del Congreso ACC Orlando 2018 23
  3. 3. Lo mejor del Congreso ACC Orlando 2018 Study Design . Short Term (ST) Cohort1 N=294 6-month follow-up Randomization 1:1 Patient meets MOMENTUM 3 eligibility criteria? Long Term (LT) Cohort N=366 2-year follow-up Additional 72 patients enrolled HeartMate 3 Pump N=190 HeartMate II Pump N=176 Withdrawn before implant N = 4 No LVAD implant: 1 Withdrawal of consent: 1 Transplant: 1 Implanted with non-study LVAD: 1 Withdrawn before implant N = 1 Death: 1 Implanted with HeartMate 3 N=189 Implanted with HeartMate II N=172 Intent-to-Treat (ITT) Population N=366 Per Protocol Population N=361 Full Cohort N=1028 2-year follow-up 1Mehra et al. A Fully Magnetically Levitated Circulatory Pump for Advanced Heart Failure. N Engl J Med 2017;376(5):440-50. 7 • SUPERVIVENCIA A LOS DOS AÑOS LIBRE DE ICTUS O REINTERVENCIÓN PARA REEMPLAZAR O RETIRAR UN SISTEMA MALFUNCIONANTE
  4. 4. Lo mejor del Congreso ACC Orlando 2018 Primary Endpoint Component 1 Overall Survival No. at Risk HeartMate 3 HeartMate II HeartMate 3 HeartMate II HR denotes hazard ratio; CI, confidence interval 12 Primary Endpoint Component 2 Freedom from Disabling Stroke No. at Risk HeartMate 3 HeartMate II HeartMate II HeartMate 3 HR denotes hazard ratio; CI, confidence interval 13
  5. 5. Lo mejor del Congreso ACC Orlando 2018
  6. 6. Lo mejor del Congreso ACC Orlando 2018
  7. 7. Lo mejor del Congreso ACC Orlando 2018 Subgroup Analyses of the Primary Endpoint (ITT) denotes bridge to transplant; BTC, bridge to candidacy; DT, destination therapy Favors HeartMate 3 Favors HeartMate II
  8. 8. Lo mejor del Congreso ACC Orlando 2018 CONCLUSIONES • HM3 fue clínicamente superior a HM2 en el seguimiento a largo plazo (2 años) • El beneficio se debió a una menor tasa de reintervención con HM3 (exceso de malfuncionamiento por trombosis del dispositivo HM2) • La tasa de ictus fue inferior con HM3 • HM3 sería especialmente útil en pacientes que deben esperar mucho tiempo en lista para TxC o que reciben asistencia como terapia de destino
  9. 9. Lo mejor del Congreso ACC Orlando 2018 Barry A. Borlaug On behalf of the NHLBI Heart Failure Clinical Research Network A Randomized Clinical Trial Inorganic Nitrite Delivery to Improve Exercise Capacity in HFpEF INDIE-HFpEF Inorganic Nitrite: Novel NO providing therapy Lundberg et al. Nat Rev Drug Disc 2008 Background
  10. 10. Lo mejor del Congreso ACC Orlando 2018 Hypothesis • As compared to placebo, 4 weeks treatment with inhaled, nebulized inorganic nitrite will improve peak exercise capacity in HFpEF patients as assessed by cardiopulmonary exercise testing (CPET). Study population •NYHA class II-IV H Fsymptoms +EF≥ 50% •Objective evidence of HF (at least one) HF hospitalization Elevated NT-proBNP or BNP Elevated rest or exercise PAWP at RHC Echo Doppler DD + Loop diuretic •Reduced exercise capacity (peak VO2≥75%) •Identify HF symptoms as the primary factor limiting ability to be active on questionnaire Versus neurologic, orthopedic or life-style factors
  11. 11. Lo mejor del Congreso ACC Orlando 2018 Study Design: Randomized, double-blind, placebo-controlled crossover study Nitrite – 4 weeks 4 weeks No drug 2 weeks Placebo – 4 weeks 4 weeks No drug 2 weeks 80 mg if tolerated46mg 80 mg if tolerated46mg Placebo – 4 weeks 4 weeks No drug 2 weeks Nitrite – 4 weeks 4 weeks No drug 2 weeks 80 mg if tolerated46mg 80 mg if tolerated46mg Visit 2: CPET, Secondary Endpoints Visit 3: CPET Secondary Endpoints Single- Dose Run In Visit 1: Baseline evaluations + Screening CPET Yes No Run In Fail Randomize Patient Tolerates Run In?
  12. 12. Lo mejor del Congreso ACC Orlando 2018 INDIE Primary End-point • Peak oxygen consumption (Peak VO2) during cardiopulmonary exercise testing p=0.27 PeakVO2(ml/min/kg) -5 0 5 10 15 20 Placebo Inorganic Nitrite Treatment Difference Primary Endpoint CONCLUSIÓN: Los nitritos inorgánicos inhalados no mejoraron la capacidad funcional (medida por VO2 max), la calidad de vida ni los niveles de Nt-proBNP
  13. 13. Lo mejor del Congreso ACC Orlando 2018 Carvedilol for PrEvention of Chemotherapy-Induced CardiotoxicitY Results of the Prospective, Randomized, Double Blind, Placebo-Controlled CECCY Trial Mônica Samuel Avila M.D., Silvia Moreira Ayub-Ferreira M.D. P.h.D., Edimar Alcides Bocchi M.D. P.h.D On behalf of all CECCY trial Investigators @monicaAGrinberg ClinicalTrials.gov Identifier: NCT01724450 No disclosures to declare
  14. 14. Lo mejor del Congreso ACC Orlando 2018 CECCY Trial Anthracycline Infusion 3 weeks 3 weeks3 weeks3 weeks Weekly Taxane Infusion Carvedilol/Placebo Treatment (20 weeks) Physical Exam Biomarkers Randomization Clinical Status, Biomarkers and Image Evaluations 12 weeks6 weeks Chemotherapy Treatment 24 weeks Echocardiography End of Evaluation Physical Exam Biomarkers Physical Exam Biomarkers Echocardiography Physical Exam Biomarkers Physical Exam Biomarkers Echocardiography Physical Exam Biomarkers Echocardiography 3 weeks 9 weeks Study Design • Chemotherapy Treatment: doxorubicin + cyclophosphamide and paclitaxel • Cumulative ANT (doxorubicin) dose: 240 mg/m2
  15. 15. Lo mejor del Congreso ACC Orlando 2018 n= 96 + 96
  16. 16. Lo mejor del Congreso ACC Orlando 2018 CECCY Trial 14% 86% Placebo no.pts withdecreaseofLVEF≥ 10% no. pts with decrease of LVEF < 10% 15% 85% Carvedilol no.pts withdecreaseofLVEF≥ 10% no. pts with decrease of LVEF < 10% Results - Primary Endpoint p=ns
  17. 17. Lo mejor del Congreso ACC Orlando 2018 Percentage of patients at the different dose ranges of carvedilol or placebo. Dose of drug (mg/day) Carvedilol (n=96) Placebo (n=96) 6.25 mg/day – no. of patients (%) 21 (21.8) 24 (25.0) 12.5 mg/day – no. of patients (%) 33 (34.3) 19 (19.7) 25 mg/day – no. of patients (%) 27 (28.1) 32 (33.3) 50 mg/day – no. of patients (%) 9 (9.3) 18 (18.7) Secondary Endpoints - BNP
  18. 18. Lo mejor del Congreso ACC Orlando 2018 Seguimiento corto (sólo 6 meses) Estudio monocéntrico La incidencia de cardiotoxicidad con dosis contemporáneas de antraciclinas fue menor que la esperada con dosis moderadas-altas El tratamiento con carvedilol no tuvo impacto sobre la función ventricular a 6 meses Carvedilol Redujo la elevación de TnI Redujo el % de pacientes con disfunción diastólica Obejtivó una tendencia a una menor elevación del LVDD
  19. 19. Lo mejor del Congreso ACC Orlando 2018 Lisinopril or Carvedilol for Prevention of Trastuzumab Induced Cardiotoxicity
  20. 20. Lo mejor del Congreso ACC Orlando 2018 Definition of Cardiotoxicity • LVEFdecreasefrom thebaselineof≥10% or • LVEFdecreasefrom thebaselineof≥5% to<50% • With or without symptoms of HF • The measurement of LVEF was made locally at each site at baseline, 3, 6, 9, and 12 months.• OBJETIVO PRIMARIO – La administración de lisinopril o carvedilol reduce la cardiotoxicidad en comparación con placebo • OBJETIVOS SECUNDARIOS – Establecer si el efecto es consistente en asociación o no a antraciclinas – Determinar si la administración de lisinopril o carvedilol da lugar a menos interrupciones de tratamiento con Trastuzumab
  21. 21. Lo mejor del Congreso ACC Orlando 2018 2 años de seguimiento (1 en tratamiento con trastuzumab)
  22. 22. Lo mejor del Congreso ACC Orlando 2018 Cardiotoxicity-free survival for the cohort with Trastuzumab + Anthracycline Probability of Cardiotoxicity Carvedilol HR 0.49 95% CI (0.27, 0.89) P=0.009 Lisinopril HR 0.53 95% CI (0.30, 0.94) P=0.015 Cardiotoxicity-free survival for the cohort with Trastuzumab only Probability of Cardiotoxicity Carvedilol HR 1.05 95% CI (0.57, 1.93) P=0.56 Lisinopril HR 1.17 95% CI (0.62, 2.20) P=0.59
  23. 23. Lo mejor del Congreso ACC Orlando 2018 Presenter: Ambarish Pandey UT Southwestern Center Dallas, TX Hospital Performance Based on 30-Day Risk Standardized Mortality and Long-Term Survival after Heart Failure : An Analysis of the GWTG-HF Registry @ambarish4786 Co-authors: K Patel, L Liang, A DeVore, D Bhatt, C Yancy, A Hernandez, P Heidenreich, J de Lemos, G Fonarow Study Objective Evaluate the association between hospital performance based on 30-day risk standardized mortality rate & long- term survival patients hospitalized with acute HF at GWTG- HF participating centers
  24. 24. Lo mejor del Congreso ACC Orlando 2018 Long-term Outcomes Q1 High Performing Q2 Q3 Q4 Low Performing Overall Population Median Survival, days (95% CI) 717 (700 – 734) 685 (668 – 705) 654 (636 – 674) 579 (565 – 594) 5-year Mortality (%) 75.6 76.2 76.9 79.6 30-day Survivors Median Survival, days (95% CI) 832 (815 – 852) 825 (805 – 843) 814 (794 – 831) 759 (742 – 779) 5-year Mortality (%) 73.7 73.7 74.3 76.8 Hospital Performance by 30-day RSMR and Long-term Survival 30-day SurvivorsOverall Population Q2 Q3 Q1 (High Performing) Q4 (Low Performing) Hazard RatioLower risk Higher risk Hazard RatioLower risk Higher risk Adjusted for patient- and hospital-level covariates 22%≥ Risk Adjusted Association of Hospital Performance by 30-day RSMR with 5-y Mortality
  25. 25. Lo mejor del Congreso ACC Orlando 2018 Ferric Iron in Heart Failure (FERRIC-HF) II Randomized Controlled Trial of the Effect of Iron Isomaltoside on Skeletal Muscle Energetics in Iron Deficient Patients with Chronic Heart Failure Darlington Obinnaya Okonko, BSc,MBBS,PhD Ferric-HF II
  26. 26. Lo mejor del Congreso ACC Orlando 2018
  27. 27. Lo mejor del Congreso ACC Orlando 2018
  28. 28. Lo mejor del Congreso ACC Orlando 2018 Lower MortalityandHeart FailureHospitalizationFollowing Implant of anAmbulatoryHemodynamicSensor JacobAbraham, MD, Orvar Jonsson, MD, Guilherme H. Oliveira, MD, Andre Artis, MD, Ali Valika, MD, Robert Capodilupo, MD, Phillip B. Adamson, MD, Gregory Roberts, BS, Nirav Dalal, MS MBA, Rupinder Bharmi, MS, Akshay S. Desai, MD, MPH, Raymond L. Benza, MD Providence Heart Institute Patient Selection N=1351patientswithsensor N=1289 N=1181 N=1176 N = 62, Discontinuous enrollment N = 108, HMO insurance N = 5, Pre-index LVAD
  29. 29. Lo mejor del Congreso ACC Orlando 2018 Lower MortalityandHeart FailureHospitalizationFollowing Implant of anAmbulatoryHemodynamicSensor JacobAbraham, MD, Orvar Jonsson, MD, Guilherme H. Oliveira, MD, Andre Artis, MD, Ali Valika, MD, Robert Capodilupo, MD, Phillip B. Adamson, MD, Gregory Roberts, BS, Nirav Dalal, MS MBA, Rupinder Bharmi, MS, Akshay S. Desai, MD, MPH, Raymond L. Benza, MD Providence Heart Institute Methods Objective: Evaluate the effectiveness of hemodynamic monitoring on reducing mortality and HFH in general population Studydesign: Retrospective cohort study based on administrative claims using 100% data from the CMS Standard Analytic File Population: • Treatment cohort: All fee for service Medicare enrollees undergoing sensor implant (6/2014–3/2016) • Control cohort: Matched 1:1 using demographic traits, co-morbidities and timing of HF hospitalization
  30. 30. Lo mejor del Congreso ACC Orlando 2018 Temporal Matching Implant 0 12mo-12mo Clinical match Clinical Matching N=1176 1. Gender, Race, ICD or CRT, ESRD, Age ± 5 yrs 2. Co-morbidities: Arrhythmia, HTN, Diabetes, Pulmonary and Renal disease 3. Closest match on propensity score 4. Exact match on HF history: # of HFH and non HFH 5. Closest match on hospitalization timing N=1.5MHospitalizedfor HF ≥ N=1087* * N = 89, No matches found Statistical Methods Outcome Methodology All-cause mortality at 12 months Kaplan-Meyer analysis HF hospitalizations at 12 months Anderson-Gill model for recurrent events (censoring for death, VAD or transplant) HFHospitalization: Pre-implant Period Treatment Cohort Control Cohort p-value Number of HFEvents 2532 2532 1.00NS Avg. LOS—days/HFH 5.5± 4.9 4.9± 4.1 P<0.01 Total timeinhosp. —days/pt. 12.7± 12.7 11.4± 11.4 P=0.01 Cohort hosp. time—days 13857 12442 0.16
  31. 31. Lo mejor del Congreso ACC Orlando 2018 784 616 0 200 400 600 800 HFH Control Cohort Treatment Cohort HFHospitalization: Post-implant Period 0.65 HFH/pt-year 0.88 HFH/pt-year 325 241 0 100 200 300 400 Death Control Cohort Treatment Cohort MortalityAfter Sensor Implant 0.22 MortalityRate 0.30 MortalityRate ProbabilityofSurvival
  32. 32. Lo mejor del Congreso ACC Orlando 2018 HF hospitalization Mortality El implante de un sensor de TA se asoció a una reducción de riesgo de mortalidad del 30% y del 24% en los reingresos. Es preciso un ensayo clínico que dé robustez a estos hallazgos (GUIDE-HF trial)
  33. 33. Lo mejor del Congreso ACC Orlando 2018 Josep Rodés-Cabau, MD, FACC Quebec Heart & Lung Institute, Laval University on behalf of V-Wave’s FIM/SAP Investigators Interatrial Shuntingfor Treating Heart Failure: EarlyandLate Resultsof theFirst-in-Human ExperienceWiththeV-Wave Interatrial Shunt System The V-Wave Shunt Porcine pericardial leaflets – Minimizes R to L shunting and risk of paradoxical embolization Hourglass shape – secure and atraumatic septal retention – minimal ID 5.1 mm ePTFE encapsulation – Channels flow – Impedes luminal obstruction due to tissue ingrowth Right Atrium Left Atrium Self-expanding Nitinol frame Interatrial septum Objective • First-in-human prospective multicenter open-label experience to assess the feasibility, safety and exploratory efficacy of interatrial shunting with the V-Wave system for patients with heart failure (reduced and preserved left ventricular ejection fraction) Outcomes • Primary – Safety: device/procedure-related major adverse cardiovascular and neurological events (MACNE), defined as death, stroke, device embolization, pericardial effusion requiring intervention, re-intervention or surgery at 3- and 12-month follow-up – Procedural success: successful device implantation with no periprocedural death • Secondary – Safety: all-cause MACNE, all serious adverse events (SAEs) and serious adverse device effects (SADEs) – Exploratory efficacy: changes in NYHA Class, quality of life, and 6MWT distance at 3- and 12-month follow-up
  34. 34. Lo mejor del Congreso ACC Orlando 2018 • Procedures/Follow-Up – Transfemoral venous approach, general anesthesia, TEE guidance – Anticoagulation for at least 3 months – Study follow-up (1, 3, 6, 12m and yearly to 5 y) Special Access Program 22 patients enrolled at 1 center in Canada First-In-Man Multicenter Feasibility Study 16 patients enrolled in 5 centers in Israel and Spain SAP FIM 38 patients implanted (30 HFrEF, 8 HFpEF) 28 month median follow-up (Range 18-48 months)llow-up Population
  35. 35. Lo mejor del Congreso ACC Orlando 2018 Outcomes /38 NE at 3M Patients (n=38) PROCEDURAL/IN-HOSPITAL Successful device implantation 38 (100) Shunt patency at procedural TEE 38 (100) Device embolization/dislocation 0 Need for a 2nd device 0 Procedural time, min 72 ± 24 Hospitalization days (median, IQR) 1, 1-2 Device/procedure-related MACNE Cardiac tamponade 1 (2.6%) SAFETY OUTCOMES (full 12-month follow-up) Cumulative device/procedure-related MACNEs Death 0 Stroke 0 Cardiac tamponade 1 (2.6) Device embolization 0 Device infection 0 Reintervention or surgery 0 Overall device/procedure-related MACNE 1 (2.6) Cumulative all-cause MACNEs Death 2 (5.2) Stroke 0 Systemic embolism 0 Ventricular tachycardia 1 (2.6) Myocardial infarction 0
  36. 36. Lo mejor del Congreso ACC Orlando 2018 Functional,EchoandHemodynamicParameters Variable Baseline (n=38) 3 Months (n=36) 12 months (n=36) *p-value Functional Status/Quality-of-Life NYHA III-IV 38 (100) 8 (22) 14 (39) <0.001 NYHA I-II 0 (0) 28 (78) 22 (61) KCCQ/MLHFQ(improve≥5points) - 27 (74) 26 (73) <0.001 6-MWT (m) 290±112 340±94 324±105 0.012 Laboratory parameters Ln NT-pro BNP (pg/mL) 7.5 ± 0.9 7.4 ± 1.0 7.5 ± 0.9 0.83 eGFR (ml·min-1·1.73 m-2) 54± 20 55 ± 23 53 ± 22 0.92 Echocardiographicvariables LVEF (HFrEF, %) 26 ± 7 27 ± 9 28 ± 8 0.54 LVEF (HFpEF, %) 50 ± 9 52 ± 10 54 ± 9 0.74 MR Grade 3.9 ± 1.5 3.5 ± 1.2 3.5 ± 1.3 0.51 LAVI (ml/m2) 42 ± 13 42 ± 13 41 ± 15 0.84 TAPSE (mm) 16 ± 4 17 ± 4 16 ± 4 0.94 Qp/Qs 0.99 ± 0.11 1.17 ± 0.12 1.10 ± 0.13 0.005 Hemodynamics PCWP (mmHg) 21 ± 5 20 ± 7 19 ± 7 0.49 RAP (mmHg) 8 ± 4 9 ± 5 9 ± 4 0.51 PAP, mean (mmHg) 30 ± 7 29 ± 8 30 ± 10 0.97 CI (L/min/m2) 2.2 ± 0.4 2.4 ± 0.4 2.3 ± 0.5 0.27 PVR (Wood Units) 2.8 ± 1.6 2.6 ± 1.1 2.8 ± 1.9 0.73 KCQC/MLHFQ (improve >5 points)
  37. 37. Lo mejor del Congreso ACC Orlando 2018 Shunt ValveFunctionat 1-3and12Months(TEE) A. Widely Patent Shunt B. Stenotic Shunt; narrowed/skewed C. Occluded Shunt • Shunt patency at 1-3 months: 36/36 (100%) • 12-month shunt occlusion: 5/36 (14%) • 12-month shunt stenosis (TEE Color Doppler vena contracta in valve region narrowed/skewed): 13/36 (36%) • No thrombus, no shunt migration, no erosion of adjacent structures Patent Stenotic p Vena Contracta 3.3±0.6 mm 1.5±1.5 mm 0.001 Qp:Qs 1.17±0.12 mm 1.05±0.12 mm 0.023 Pathological Examination(StenoticShunt) 2.5 year explant specimen from transplanted patient A. LA view. Orifice widely patent. B. RA view. Pannus thickening with stenosis of bioprosthetic leaflets. C. Axial Section (H&E). Fibrocellular neoendocardium (pannus) infiltration of leaflets. D. SEM. Full endothelialization of lumen (CD31+)
  38. 38. Lo mejor del Congreso ACC Orlando 2018 HemodynamicChangesGroupedbyShunt Patencyat 1-Year Follow-Up Patent ≥ Stenotic/Occluded ≥ At baseline, patients with patent shunts were: • Older • AF • eGFR • 6MWT • PCWP, CO Long-termClinical OutcomesGroupedbyShunt Patency
  39. 39. Lo mejor del Congreso ACC Orlando 2018 ComparisonwithCMEMsChampionStudy Studies had similar: • eligibility criteria • baseline characteristics including hemodynamics • use of medical and device therapies including dosing
  40. 40. Lo mejor del Congreso ACC Orlando 2018 • El shunt interauricular con el dispositivo V-Wave es seguro y parece relacionarse con mejoría funcional y reducción de eventos cardiovasculares •Existe una alta tasa de estenosis/oclusión del dispositivo al año (pannus) y ésta se asoció a peor perfil hemodinámico y más eventos

×