Table 2.
Studies evaluating infection in balloon and self-expanded TAVR.
| First Author/ Year/ Type of Study |
Total Number | TAVR Model | Type of Material | No. of TAVR-IE Patients | Yr. Incidence of TAVR-IE | Microbiology | Finding | Ref |
|---|---|---|---|---|---|---|---|---|
| Makkar 2020 Lancet RCT |
750 |
† Portico, * SAPIEN, SAPIEN XT, SAPIEN 3, * CoreValve, Evolut-R, Evolut-PRO |
Porcine-L/Nitonol-S Bovine-L/CrCo-S |
- | - | - | Not designed to detect endocarditis |
[29] |
| Lanz 2019 Lancet RCT |
739 | γACURATE neo, SAPIEN 3 | Porcine-L/Nitinol-S Bovine-L/CrCo-S |
3 at 30 days | NA | NA | Similar rates of IE between ACURATE neo and SAPIEN 3. Superiority of SAPIEN 3 for early safety and efficacy | [32] |
| Mack 2019 NEJM RCT |
496 | SAPIEN 3 | Bovine-L/CrCo-S | - | - | - | Not designed to detect endocarditis |
[30] |
| Regueiro 2016 JAMA Retrospective |
20006 | CoreValve System SAPIEN |
Porcine-L/Nitinol-S Bovine-L/CrCo-S |
250 at 1 y | 1.1% |
Enterococci (24.6%), S. aureus (3.8%), CoNS |
IE associated with younger age, male sex, history of diabetes, moderate to severe residual aortic regurgitation IE patients had high rates of in-hospital mortality and 2-year mortality |
[28] |
| Mangner 2016 JACC OS |
1820 | CoreValve System | Porcine-L/Nitinol-S | 55 at 1 y | 1.82% |
CoPS (38.2%), MRSA and Enterococci (30.9%), CoNS (9.1%) |
Patients in chronic hemodialysis at highest risk group for development and death by IE. Poor prognosis of IE patients | [40] |
Abbreviations: ACCURATE neo = self-expandable heart valve; CrCo = chromium-cobaltum; RCT = randomized clinical trial; CoreValve System = self-expandable transcatheter heart valve; OS = observational study; PORTICO IDE = the Portico Re-sheathable Transcatheter Aortic Valve System U.S. Investigational Device Exemption trial; TAVR = transcatheter aortic valve replacement; SAVR = surgical aortic valve replacement; * CoreValve System included CoreValve, Evolut-R, Evolut-PRO (Medtronic, Minneapolis, MN, USA). * SAPIEN included SAPIEN, SAPIEN XT, and SAPIEN 3 (Edwards Lifesciences Irvine, CA, USA); χnot specified which of SAPIEN family. † PORTICO (Abbott Structural Heart, St Paul, MN, USA). γACURATE neo (BostonScientific, Marlborough, MA, USA).