PMID- 31566572
OWN - NLM
STAT- MEDLINE
DCOM- 20200924
LR  - 20200924
IS  - 1969-6213 (Electronic)
IS  - 1774-024X (Linking)
VI  - 16
IP  - 5
DP  - 2020 Aug 28
TI  - First-in-human evaluation of a novel balloon-expandable transcatheter heart valve 
      in patients with severe symptomatic native aortic stenosis: the MyVal-1 study.
PG  - 421-429
LID - EIJ-D-19-00413 [pii]
LID - 10.4244/EIJ-D-19-00413 [doi]
AB  - AIMS: The aim of this study was to demonstrate the safety and efficacy of the 
      next-generation balloon-expandable Myval transcatheter heart valve (THV) in an 
      intermediate- or high-risk patient population with severe symptomatic native 
      aortic stenosis. METHODS AND RESULTS: MyVal-1 was a first-in-human, prospective, 
      multicentre, single-arm, open-label study. Between June 2017 and February 2018, a 
      total of 30 patients were enrolled at 14 sites across India. Mean age was 
      75.5+/-6.7 years; 43.3% had coronary artery disease. The mean Society of Thoracic 
      Surgeons score was 6.4+/-1.8% and 100% of the patients were in New York Heart 
      Association (NYHA) functional Class II/III/IV pre-procedure. The six-minute walk 
      test and Kansas City Cardiomyopathy Questionnaire (KCCQ) scores were recorded. 
      After successful implantation of the Myval THV, 96.6% and 100% were in NYHA 
      functional Class I/II at 30-day and 12-month follow-up, respectively. Outcomes of 
      the six-minute walk test (148.0+/-87.4 vs 336.0+/-202.9 m) and KCCQ score (36.6+/-11.0 
      vs 65.9+/-11.4) improved from baseline to 12-month follow-up. The effective orifice 
      area (0.6+/-0.2 vs 1.8+/-0.3 cm2, p<0.0001), mean aortic valve gradient (47.4+/-8.8 vs 
      12.0+/-3.3 mmHg, p<0.0001), peak aortic valve gradient (71.7+/-13.0 vs 20.3+/-5.9 mmHg, 
      p<0.0001) and transaortic velocity (4.5+/-0.4 vs 2.2+/-0.4 m/s, p<0.0001) improved 
      substantially from baseline to 12 months post procedure. Four all-cause mortality 
      cases were reported up to 12 months. Moreover, there was no other moderate/severe 
      paravalvular leak, aortic regurgitation or need for new permanent pacemaker (PPM) 
      up to 12-month follow-up. CONCLUSIONS: The MyVal-1 study demonstrated the primary 
      safety and efficacy of the Myval THV with no new PPM requirement up to 12-month 
      follow-up. However, future trials with a larger number of patients and long-term 
      follow-up are warranted to establish the safety and efficacy of the device.
FAU - Sharma, Samin K
AU  - Sharma SK
AD  - Mount Sinai Health System, New York, NY, USA.
FAU - Rao, Ravinder Singh
AU  - Rao RS
FAU - Chandra, Praveen
AU  - Chandra P
FAU - Goel, Pravin Kumar
AU  - Goel PK
FAU - Bharadwaj, Prashant
AU  - Bharadwaj P
FAU - Joseph, George
AU  - Joseph G
FAU - Jose, John
AU  - Jose J
FAU - Mahajan, Ajaykumar U
AU  - Mahajan AU
FAU - Mehrotra, Sanjay
AU  - Mehrotra S
FAU - Sengottovelu, Gunasekaran
AU  - Sengottovelu G
FAU - Ajit Kumar, V K
AU  - Ajit Kumar VK
FAU - Manjunath, Cholenahally N
AU  - Manjunath CN
FAU - Abhaichand, Rajpal K
AU  - Abhaichand RK
FAU - Sethi, Rishi
AU  - Sethi R
FAU - Seth, Ashok
AU  - Seth A
CN  - Collaborators
LA  - eng
PT  - Journal Article
PL  - France
TA  - EuroIntervention
JT  - EuroIntervention : journal of EuroPCR in collaboration with the Working Group on 
      Interventional Cardiology of the European Society of Cardiology
JID - 101251040
SB  - IM
EIN - EuroIntervention. 2020 Aug 28;16(5):429. PMID: 32855114
MH  - Aged
MH  - Aged, 80 and over
MH  - Aortic Valve/surgery
MH  - Aortic Valve Stenosis/*surgery
MH  - *Heart Valve Prosthesis
MH  - Humans
MH  - India
MH  - Prospective Studies
MH  - Prosthesis Design
MH  - Transcatheter Aortic Valve Replacement/*adverse effects
MH  - Treatment Outcome
FIR - Sonawane, Anmol
IR  - Sonawane A
EDAT- 2019/10/01 06:00
MHDA- 2020/09/25 06:00
CRDT- 2019/10/01 06:00
PHST- 2019/10/01 06:00 [pubmed]
PHST- 2020/09/25 06:00 [medline]
PHST- 2019/10/01 06:00 [entrez]
AID - EIJ-D-19-00413 [pii]
AID - 10.4244/EIJ-D-19-00413 [doi]
PST - ppublish
SO  - EuroIntervention. 2020 Aug 28;16(5):421-429. doi: 10.4244/EIJ-D-19-00413.