Transcatheter Aortic Valve Replacement in India-Early Experience, Challenges, and Outcomes from a Single Center

Background: Despite the increasing popularity of transcatheter aortic valve replacement (TAVR), only about 10,000 TAVR cases have been performed in Asia to date. The procedure is still in a nascent stage in India with very few centers offering this state-of-art technique. Here, we present the early results of TAVR experience at our center.

Methods: Forty-nine patients with severe symptomatic aortic stenosis (AS) were referred to our center for TAVR from November 2015 to February 2018. Twenty-five patients underwent TAVR at our conventional cardiac catheterization laboratory under local or general anesthesia, with standby surgical team support.

Results: The mean age of the patients was 72.0 ± 8.1 years. The mean Society of Thoracic Surgeons score was 13.8 ± 10.2. Baseline mean ejection fraction was 50.3 ± 14.8%. Baseline mean aortic valve gradient was 55.8 ± 24.7 mmHg. There was one procedural-related death. Two of the patients required urgent surgery: one for contained annular rupture and one underwent vascular repair for femoral artery occlusion. Mild and moderate paravalvular leak was seen in 11 and 3 patients, respectively. Four patients (16%) required permanent pacemaker. Eighty percent were in New York Heart Association class I-II at discharge. One-year all-cause mortality was 8%, with no hospitalizations or major adverse cardiac event during the 1-year follow-up.

Conclusion: Our early data clearly shows that in our country, TAVR is a good alternative for symptomatic severe AS for high surgical risk cases. Large-scale multicenter studies are required to study the real impact of TAVR in the Indian scenario. During initial years of implementation of a nationwide TAVR program, it may be prudent to focus on creating TAVR Centers of Excellence by developing an ideal hub and spokes model.

Citing Articles

Early and late outcomes after transcatheter aortic valve implantation in Indian subpopulation.

Agarwal A, Sasidharan B, Valaparambil A Indian Heart J. 2022; 74(5):425-427.

PMID: 36089057 PMC: 9647657. DOI: 10.1016/j.ihj.2022.09.002.

National interventional council data for the year 2018-India.

Arramraju S, Janapati R, Sanjeeva Kumar E, Mandala G Indian Heart J. 2020; 72(5):351-355.

PMID: 33189193 PMC: 7670256. DOI: 10.1016/j.ihj.2020.07.018.

References

Leon M, Smith C, Mack M, Miller D, Moses J, Svensson L . 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. View

Smith C, Leon M, Mack M, Miller D, Moses J, Svensson L . Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med. 2011; 364(23):2187-98. DOI: 10.1056/NEJMoa1103510. View

Chiam P, Koh A, Ewe S, Sin Y, Chao V, Ng C . Iliofemoral anatomy among Asians: implications for transcatheter aortic valve implantation. Int J Cardiol. 2012; 167(4):1373-9. DOI: 10.1016/j.ijcard.2012.04.001. View

Vahanian A, Alfieri O, Andreotti F, Antunes M, Baron-Esquivias G, Baumgartner H . Guidelines on the management of valvular heart disease (version 2012): 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). Eur J Cardiothorac Surg. 2012; 42(4):S1-44. DOI: 10.1093/ejcts/ezs455. View

Osnabrugge R, Mylotte D, Head S, Van Mieghem N, Nkomo V, LeReun C . Aortic stenosis in the elderly: disease prevalence and number of candidates for transcatheter aortic valve replacement: a meta-analysis and modeling study. J Am Coll Cardiol. 2013; 62(11):1002-12. DOI: 10.1016/j.jacc.2013.05.015. View

Rajendran H, Seshayyan S, Victor A, Rajapandian G . Aortic valve annular dimension in Indian population. J Clin Diagn Res. 2013; 7(9):1842-5. PMC: 3809616. DOI: 10.7860/JCDR/2013/5776.3329. View

Adams D, Popma J, Reardon M, Yakubov S, Coselli J, Deeb G . Transcatheter aortic-valve replacement with a self-expanding prosthesis. N Engl J Med. 2014; 370(19):1790-8. DOI: 10.1056/NEJMoa1400590. View

Watanabe Y, Hayashida K, Takayama M, Mitsudo K, Nanto S, Takanashi S . First direct comparison of clinical outcomes between European and Asian cohorts in transcatheter aortic valve implantation: the Massy study group vs. the PREVAIL JAPAN trial. J Cardiol. 2014; 65(2):112-6. DOI: 10.1016/j.jjcc.2014.05.001. View

Manjunath C, Srinivas P, Ravindranath K, Dhanalakshmi C . Incidence and patterns of valvular heart disease in a tertiary care high-volume cardiac center: a single center experience. Indian Heart J. 2014; 66(3):320-6. PMC: 4121759. DOI: 10.1016/j.ihj.2014.03.010. View

10.

Mack M, Leon M, Smith C, Miller D, Moses J, Tuzcu E . 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):2477-84. DOI: 10.1016/S0140-6736(15)60308-7. View

11.

Reynolds M, Lei Y, Wang K, Chinnakondepalli K, Vilain K, Magnuson E . Cost-Effectiveness of Transcatheter Aortic Valve Replacement With a Self-Expanding Prosthesis Versus Surgical Aortic Valve Replacement. J Am Coll Cardiol. 2016; 67(1):29-38. PMC: 4959424. DOI: 10.1016/j.jacc.2015.10.046. View

12.

Leon M, Smith C, Mack M, Makkar R, Svensson L, Kodali S . Transcatheter or Surgical Aortic-Valve Replacement in Intermediate-Risk Patients. N Engl J Med. 2016; 374(17):1609-20. DOI: 10.1056/NEJMoa1514616. View

13.

Reardon M, Van Mieghem N, Popma J, Kleiman N, Sondergaard L, Mumtaz M . Surgical or Transcatheter Aortic-Valve Replacement in Intermediate-Risk Patients. N Engl J Med. 2017; 376(14):1321-1331. DOI: 10.1056/NEJMoa1700456. View