Patient Selection

One of the most critical factors in achieving good outcomes in TAR is appropriate patient selection.1 The Society for Thoracic Surgery (STS) risk score is frequently used as a starting point to stratify patients and is independent predictor of 1-year mortality, although it does not account for all comorbid conditions.1,5 However, the STS score is not validated in the high-risk (and potentially inoperable) population and does not take frailty into account.1,5 Risk stratification involves both clinical and geriatric domains.5 (Table 4)

Table 4: Predictors of Increased Risk


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Risk Stratification Category

Factors to Take Into Account

Clinical

  • Very high STS score (predicted risk of mortality >15%)
  • Severely reduced LV function
  • Very low transvalvular gradient (<20 mmHg)
  • Low flow (<35 ml/m2)
  • Severe myocardial fibrosis
  • Severe contimitant mitral and/or tricuspid valve disease
  • Severe pulmonary hypertension (PASP ≥60 mm Hg)
  • Severe lung disease
  • Advanced renal impairment
  • Liver disease

Geriatric

  • Frailty
  • Disability
  • Cognitive impairment
  • Mood disturbance
  • Malnutrition
  • Polypharmacy
  • Fall risk
  • Social isolation

LV=left ventricular; PASP=pulmonary artery systolic pressure; STS=Society of Thoracic Surgery

References

Lindman BR, Alexander KP, O’Gara PT, Afilalo J. Futility, benefit, and transcatheter aortic valve replacement. JACC Cardiovasc Interv. 2014;7(7):707-716. doi:10.1016/j.jcin.2014.01.167.

Expanded Indications for TAVR

TAVR is being investigated for use in younger, low-risk patients, although many low-risk patients are not appropriate candidates.17 B icuspid aortic valve (BiAV) is a common congenital valve condition in younger patients18 and contraindicated for TAVR, according to current guidelines.4,19 (Table 5) However, TAVR may be technically feasible in selected BiAV patients, with acceptable mid-term clinical outcomes.20 Unresolved issues include long-term valve durability and the relatively high rate of paravalvular leakage. As devices evolve, it is hoped that these difficulties can be overcome.20

The NOTION (Nordic Aortic valve Intervention)trial compared TAVR (using CoreValve) with SAVR in 280 patients over age 70 with severe AD, but at low risk for surgery. The researchers found no significant differences in the composite rate of death between the 2 groups after 1 year. However, the TAVR group experienced more conduction abnormalities and more total aortic valve regurgitation, while the SAVR group had more episodes of major bleeding, cardiogenic shock, and new-onset or worsening AF.21

Table 5: Recommendations of the ACA/AHA Guideline for Management of Patients with Valvular Disease

  • Surgical AVR recommended in patients who meet an indication for AVR, with low or intermediate surgical risk
  • For patients in whom TAVR or high-risk surgical AVR is being considered, members of a Heart Valve team should collaborate to provide optimal patient care
  • TAVR is recommended in patients who meet an indication for AVR for AS who have a prohibitive surgical risk and a predicted post-TAVR survival >12 months
  • TAVR is a reasonable alternative to surgical AVR in patients who meet an indication for AVR and who have high surgical risk
  • Percutaneous aortic balloon dilation may be considered as a bridge to surgical or transcatheter AVR in severely symptomatic patients with severe AS
  • TAVR is not recommended in patients in whom existing comorbidities would preclude the expected benefit from correction of AS

References

Nishimura RA, Otto CM, Bonow RO, et al. 2014 AHA/ACC guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2014;63(22):e57-185. doi: 10.1016/j.jacc.2014.02.536.

Goals for clinicians

Considering the complexity and potential risks of TAVR, it is essential that the decision be made by a multidisciplinary heart valve team that includes cardiac surgeons, interventional cardiologists, and non-invasive cardiologists. It may be relevant to consult with imaging specialists, nurses, and geriatricians, as well as dieticians, physiotherapists, and possibly ethicists.5 

“A discussion between patients and physicians regarding the best approach is highly individual, and there are pros and cons or each patient,” Dr Dvir noted.

The patient’s values, goals and preferences must be taken into account in a shared decision-making process. The patient must have intact cognitive functioning and no significant depression.5 Factors that may affect the patient’s healthcare goals include life circumstances, priorities, social setting, beliefs, and life phase. For example, older patients may prefer less aggressive care than younger patients.22

Conclusion

“When we started investigating TAVR, we were looking for a less invasive approach to severe AS,” Dr Dvir reported. All the signals point toward favorable results in younger and lower-risk patients.

Dr Dvir conveyed that while the original vision has come to pass, many challenges remain. All signals point toward favorable results in younger and lower-risk patients, and ongoing trials should help  clarify the viability of broader applications of this therapeutic intervention, he said.

References

  1. Tang GH, Lansman SL, Panza JA. Beyond PARTNER: appraising the evolving trends and outcomes in transcatheter aortic valve replacement. Cardiol Rev. 2015;23(1):1-10. doi: 10.1097/CRD.0000000000000043.
  2. Mangieri A, Regazzoli D, Ruparelia N, et al. Recent advances in transcatheter aortic valve replacement for high-risk patients. Expert Rev Cardiovasc Ther. 2015;13(11):1237-49. doi: 10.1586/14779072.2015.1093935.
  3. Holmes DR Jr, Mack MJ, Kaul S, et al. 2012 ACCF/AATS/SCAI/STS expert consensus document on transcatheter aortic valve replacement: developed in collaboration with the American Heart Association, American Society of Echocardiography, European Association for Cardio-Thoracic Surgery, Heart Failure Society of America, Mended Hearts, Society of Cardiovascular Anesthesiologists, Society of Cardiovascular Computed Tomography, and Society for Cardiovascular Magnetic Resonance. J Thorac Cardiovasc Surg. 2012;144(3):e29-84.
  4. Vahanian A, Alfieri O, Andreotti F, et al; for the Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). Guidelines on the management of valvular heart disease (version 2012). Eur Heart J. 2012;33(19):2451-2496. doi: http://dx.doi.org/10.1093/eurheartj/ehs109.
  5. Lindman BR, Alexander KP, O’Gara PT, Afilalo J. Futility, benefit, and transcatheter aortic valve replacement. JACC Cardiovasc Interv. 2014;7(7):707-716. doi:10.1016/j.jcin.2014.01.167.
  6. Bourantas CV, Serruys PW. Evolution of transcatheter aortic valve replacement. Circ Res. 2014;14;114(6):1037-1051. doi: 10.1161/CIRCRESAHA.114.302292.
  7. Leon MB, Smith CR, Mack M, et al. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010;363(17):1597-607. doi: 10.1056/NEJMoa1008232.
  8. Smith CR, Leon MB, Mack MJ et al. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med. 2011;364(23):2187-2198. doi: 10.1056/NEJMoa1103510.
  9. Kodali SK, Williams MR, Smith CR, et al. Two-year outcomes after transcatheter or surgical aortic-valve replacement. N Engl J Med. 2012;366(18):1686-1695. doi: 10.1056/NEJMoa1200384.
  10. Mack MJ, Leon MB, Smith CR, et al. 5-year outcomes of transcatheter aortic valve replacement or surgical aortic valve replacement for high surgical risk patients with aortic stenosis (PARTNER 1): a randomised controlled trial. Lancet. 2015;385(9986):2433-2546. doi: http://dx.doi.org/10.1016/S0140-6736(15)60308-7.
  11. Popma JJ, Adams DH, Reardon MJ, et al. Transcatheter aortic valve replacement using a self-expanding bioprosthesis in patients with severe aortic stenosis at extreme risk for surgery. J Am Coll Cardiol. 2014;63(19):1972–1981. doi: 10.1016/j.jacc.2014.02.556.
  12. Murray MI, Geis N, Pleger ST, et al. First experience with the new generation Edwards Sapien 3 aortic bioprosthesis: procedural results and short term outcome. J Interv Cardiol. 2015;28(1):109-116. doi: 10.1111/joic.12182.
  13. Leon MB. A randomized evaluation of the SAPIEN XT transcatheter valve system in patients with aortic stenosis who are not candidates for surgery: PARTNER II, inoperable cohort. Presented at the American College of Cardiology Scientific Sessions; March 10-16, 2013; San Francisco, CA. Available at: http://www.acc.org/education-and-meetings/image-and-slide-gallery/media-detail?id=0358e247127c4aab96ee1ff53f869ebc. Accessed December 2, 2015.
  14. Kodali SK. Early Clinical and Echocardiographic Outcomes with the SAPIEN 3 transcatheter aortic valve replacement system in inoperable, high-risk and intermediate-risk aortic stenosis patients. Presented at the American College of Cardiology Annual Meeting; March 14-16, 2015; San Diego, CA. Available at:  http://my.americanheart.org/idc/groups/ahamah-public/@wcm/@sop/@scon/documents/downloadable/ucm_472792.pdf. Accessed December 9, 2015.
  15. Dvir D. Trasnscatheter aortic valve replacement for failed surgical bioprosthesis: 1-year results from the PARTNER II valve-in-valve registry. Presented at the Transcatheter Cardiovascular Therapeutics Scientific Symposium; October 11-15, 2015; San Francisco, CA.
  16. Reardon MJ. A randomized comparison of self-expanding transcatheter and surgical aortic valve replacement in patients with severe aortic stenosis deemed at increased risk for surgery 2-year outcomes. Presented at the American College of Cardiology Annual Meeting; March 14-16, 2015; San Diego, CA. Available at:  http://my.americanheart.org/idc/groups/ahamah-public/@wcm/@sop/@scon/documents/downloadable/ucm_472800.pdf. Accessed December 9, 2015.
  17. Haussig S, Linke A. Should transcatheter aortic valve replacement be expanded to lower-risk and younger patients? Circulation. 2014;130:2321-2331. doi: 10.1161/CIRCULATIONAHA.114.008144.
  18. Siu SC, Silversides CK. Bicuspid aortic valve disease. J Am Coll Cardiol. 2010;55(25):2789-2800. doi: 10.1016/j.jacc.2009.12.068.
  19. Nishimura RA, Otto CM, Bonow RO, et al. 2014 AHA/ACC guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2014;63(22):e57-185. doi: 10.1016/j.jacc.2014.02.536.
  20. Kochman J, Rymuza B, Huczek Z. Transcatheter aortic valve replacement in bicuspid aortic valve disease. Curr Opin Cardiol. 2015;30(6):594-602. doi: 10.1097/HCO.0000000000000219.
  21. Thyregod HG, Steinbrüchel DA, Ihlemann N, et al. Transcatheter versus surgical aortic valve replacement in patients with severe aortic valve stenosis: 1-year results from the All-Comers NOTION Randomized Clinical Trial. J Am Coll Cardiol. 2015;65(20):2184-94. doi:10.1016/j.jacc.2015.03.014.
  22. Hamel MB, Lynn J, Teno JM, et al. Age-related differences in care preferences, treatment decisions, and clinical outcomes of seriously ill hospitalized adults: lessons from SUPPORT. J Am Geriatr Soc. 2000;48(5 Suppl):S176-S82.