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Archive for the ‘Prosthesis-Patient Mismatch (PPM) in TAVI vs SAVR’ Category


Surgical Aortic Valve Replacement (SAVR) vs Transcatheter Aortic Valve Implantation (TAVI): Results Comparison for Prosthesis-Patient Mismatch (PPM) – adjusted outcomes, including mortality, heart failure (HF) rehospitalization, stroke, and quality of life, at 1 year

 

Reporter: Aviva Lev-Ari, PhD, RN

 

J Am Coll Cardiol. 2018 Sep 18. pii: S0735-1097(18)38287-1. doi: 10.1016/j.jacc.2018.09.001. [Epub ahead of print]

Prosthesis-Patient Mismatch in 62,125 Patients Following Transcatheter Aortic Valve Replacement: From the STS/ACC TVT Registry.

Abstract

BACKGROUND:

Prosthesis-patient mismatch (PPM) after surgical aortic valve replacement (AVR) for aortic stenosis is generally associated with worse outcomes. Transcatheter AVR (TAVR) can achieve a larger valve orifice and the effects of PPM after TAVR are less well studied.

OBJECTIVES:

The authors utilized the Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) registry to examine the frequency, predictors, and association with outcomes of PPM after TAVR in 62,125 patients enrolled between 2014 and 2017.

METHODS:

On the basis of the discharge echocardiographic effective valve area indexed to body surface area, PPM was classified as severe (<0.65 cm2/m2), moderate (0.65 to 0.85 cm2/m2), or none (>0.85 cm2/m2). Multivariable regression models were utilized to examine predictors of severe PPM as well as adjusted outcomes, including mortality, heart failure (HF) rehospitalization, stroke, and quality of life, at 1 year in 37,470 Medicare patients with claims linkage.

RESULTS:

  • Severe and moderate PPM were present following TAVR in 12% and 25% of patients, respectively. Predictors of severe PPM included small (≤23-mm diameter) valve prosthesis, valve-in-valve procedure, larger body surface area, female sex, younger age, non-white/Hispanic race, lower ejection fraction, atrial fibrillation, and severe mitral or tricuspid regurgitation.
  • At 1 year, mortality was 17.2%, 15.6%, and 15.9% in severe, moderate, and no PPM patients, respectively (p = 0.02).
  • HF rehospitalization had occurred in 14.7%, 12.8%, and 11.9% of patients with severe, moderate, and no PPM, respectively (p < 0.0001).
  • There was no association of severe PPM with stroke or quality of life score at 1 year.

CONCLUSIONS:

Severe PPM after TAVR was present in 12% of patients and was associated with higher mortality and HF rehospitalization at 1 year. Further investigation is warranted into the prevention of severe PPM in patients undergoing TAVR.

KEYWORDS:

aortic stenosis; prosthesis–patient mismatch; transcatheter aortic valve replacement

PMID:
30257798
DOI:
10.1016/j.jacc.2018.09.001

SOURCE

https://www.ncbi.nlm.nih.gov/pubmed/30257798

 

Prior Meta Analysis Study

Ann Thorac Surg. 2016 Mar;101(3):872-80

 

Ann Thorac Surg. 2016 Mar;101(3):872-80. doi: 10.1016/j.athoracsur.2015.11.048. Epub 2016 Jan 29.

Prosthesis-Patient Mismatch After Transcatheter Aortic Valve Implantation.

Abstract

BACKGROUND:

We reviewed currently available studies that investigated prosthesis-patient mismatch (PPM) in transcatheter aortic valve implantation (TAVI) with a systematic literature search and meta-analytic estimates.

METHODS:

To identify all studies that investigated PPM in TAVI, MEDLINE and EMBASE were searched through August 2015. Studies considered for inclusion met the following criteria: the study population included patients undergoing TAVI and outcomes included at least post-procedural PPM prevalence. We performed three quantitative meta-analyses about (1) PPM prevalence after TAVI, (2) PPM prevalence after TAVI versus surgical aortic valve replacement (SAVR), and (3) late all-cause mortality after TAVI in patients with PPM versus patients without PPM.

RESULTS:

We identified 21 eligible studies that included data on a total of 4,000 patients undergoing TAVI. The first meta-analyses found moderate PPM prevalence of 26.7%, severe PPM prevalence of 8.0%, and overall PPM prevalence of 35.1%. The second meta-analyses of six studies, including 745 patients, found statistically significant reductions in moderate (p = 0.03), severe (p = 0.0003), and overall (p = 0.02) PPM prevalence after TAVI relative to SAVR. The third meta-analyses of five studies, including 2,654 patients, found no statistically significant differences in late mortality between patients with severe PPM and patients without PPM (p = 0.44) and between patients with overall PPM and patients without PPM (p = 0.97).

CONCLUSIONS:

Overall, moderate, and severe PPM prevalence after TAVI was 35%, 27%, and 8%, respectively, which may be less than that after SAVR. In contrast to PPM after SAVR, PPM after TAVI may not impair late survival.

Comment in

 

Other related studies published on TAVR, TAVI in this Open Access Online Scientific Journal include the following:

 

  • New method for performing Aortic Valve Replacement: Transmural catheter procedure developed at NIH, Minimally-invasive tissue-crossing – Transcaval access, abdominal aorta and the inferior vena cava

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2016/10/31/new-method-for-performing-aortic-valve-replacement-transmural-catheter-procedure-developed-at-nih-minimally-invasive-tissue-crossing-transcaval-access-abdominal-aorta-and-the-inferior-vena-cava/

 

  • Second in the United States to implant Edwards Newly FDA-Approved Aortic Valve “Intuity Elite” Sutureless Valve at Northwestern Medicine

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2016/10/13/second-in-the-united-states-to-implant-edwards-newly-fda-approved-aortic-valve-intuity-elite-sutureless-valve-at-northwestern-medicine/

 

  • Medtronic’s CoreValve System Sustains Positive Outcomes Through Two Years in Extreme Risk Patients

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2014/09/15/medtronics-corevalve-system-sustains-positive-outcomes-through-two-years-in-extreme-risk-patients/

 

  • One year Post-Intervention Mortality Rate: TAVR and AVR – Aortic Valve Procedures 6.7% in AVR, 11.0% in AVR with CABG, 20.7 in Transvascular (TV-TAVR) and 28.0% in Transapical (TA-TAVR) Patients

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2014/08/04/one-year-post-intervention-mortality-rate-tavr-and-avr-aortic-valve-procedures-6-7-in-avr-11-0-in-avr-with-cabg-20-7-in-transvascular-tv-tavt-and-28-0-in-transapical-ta-tavr-patients/

 

  • Developments on the Frontier of Transcatheter Aortic Valve Replacement (TAVR) Devices

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2014/01/26/developments-on-the-frontier-of-transcatheter-aortic-valve-replacement-tavr-devices/

 

  • Off-Label TAVR Procedures: 1 in 10 associated with higher in-hospital 30-day mortality, 1-year mortality was similar in the Off-Label and the On-Label groups

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2017/06/22/off-label-tavr-procedures-1-in-10-associated-with-higher-in-hospital-30-day-mortality-1-year-mortality-was-similar-in-the-off-lavel-and-the-on-label-groups/

 

  • First U.S. TAVR Patients Treated With Temporary Pacing Lead (Tempo Lead)

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2016/12/21/first-u-s-tavr-patients-treated-with-temporary-pacing-lead-tempo-lead/

 

  • SAPIEN 3 Transcatheter Aortic Valve Replacement in High-Risk and Inoperable Patients with Severe Aortic Stenosis: One-Year Clinical Outcomes

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2016/07/14/sapien-3-transcatheter-aortic-valve-replacement-in-high-risk-and-inoperable-patients-with-severe-aortic-stenosis-one-year-clinical-outcomes/

 

  • TAVR with Sapien 3: combined all-cause death & disabling stroke rate was 8.4% and 16.6% for the surgery arm

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2016/04/05/tavr-with-sapien-3-combined-all-cause-death-disabling-stroke-rate-was-8-4-and-16-6-for-the-surgery-arm/

 

  • Hadassah Opens Israel’s First Heart Valve Disease Clinic

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2016/12/06/hadassah-opens-israels-first-heart-valve-disease-clinic/

  • Trans-apical Transcatheter Aortic Valve Replacement in a Patient with Severe and Complex Left Main Coronary Artery Disease (LMCAD)

Author: Larry H Bernstein, MD, FCAP and Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/06/17/management-of-difficult-trans-apical-transcatheter-aortic-valve-replacement-in-a-patient-with-severe-and-complex-arterial-disease/

 

  • Transcatheter Aortic Valve Replacement (TAVR): Postdilatation to Reduce Paravalvular Regurgitation During TAVR with a Balloon-expandable Valve

Curator: Larry H Bernstein, MD, FCAP and Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/06/17/postdilatation-to-reduce-paravalvular-regurgitation-during-transcatheter-aortic-valve-replacement/

 

  • Transcatheter Aortic-Valve Replacement for Inoperable Severe Aortic Stenosis


Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2012/09/03/transcatheter-aortic-valve-replacement-for-inoperable-severe-aortic-stenosis/

 

  • Updated Transcatheter Aortic Valve Implantation (TAVI): risk for stroke and suitability for surgery

Reporter: Aviva Lev-Ari, PhD,RN

https://pharmaceuticalintelligence.com/2012/08/07/transcatheter-aortic-valve-implantation-tavi-risky-and-costly-2/

 

  • The Centers for Medicare & Medicaid Services (CMS) covers transcatheter aortic valve replacement (TAVR) under Coverage with Evidence Development (CED)

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2012/06/19/the-centers-for-medicare-medicaid-services-cms-covers-transcatheter-aortic-valve-replacement-tavr-under-coverage-with-evidence-development-ced/

 

  • Investigational Devices: Edwards Sapien Transcatheter Aortic Heart Valve Replacement Transfemoral Deployment

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2012/06/10/investigational-devices-edwards-sapien-transcatheter-aortic-heart-valve-replacement-transfemoral-deployment/

 

  • Investigational Devices: Edwards Sapien Transcatheter Aortic Valve Transapical Deployment

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2012/06/04/investigational-devices-edwards-sapien-transcatheter-heart-valve/

 

 

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