Two-year Experience with balloon-Expandable Transcatheter Aortic Valve Replacement in Severe Aortic Stenosis at a Tertiary Center
Abstract
Objective Aortic stenosis (AS) is the most common valvular heart disease requiring intervention, particularly in developed countries. Transcatheter aortic valve replacement (TAVR) is indicated for patients with a high surgical risk and a post-procedural survival expectancy of more than 12 months. Over the years, the TAVR method has emerged as a significant treatment option for patients with symptomatic severe AS and has begun to be implemented in our country as well. The objective of this study was to evaluate the short and long-term outcomes of patients undergoing TAVR at our center, as well as to assess our institution's experience with the TAVR procedure. Methods This retrospective, single-center analysis included 16 consecutive patients with symptomatic AS who underwent TAVR between March 2022 and February 2024. All patients included in the study underwent implantation of a balloon-expandable TAVR valve. In the study, the demographic characteristics of patients preoperatively and during post-procedural follow-ups, their clinical status preoperatively and postoperatively, and echocardiographic findings were evaluated and compared. Results The mean age of the entire population was 78.3 ± 8.7 years, and 50% were women. Transfemoral access was used in 93.8% of patients. Implantation success was achieved in all cases. During the TAVI procedure, 12.5% of patients required permanent pacemaker implantation. The mean length of hospital stay for the entire cohort was 4.5±2.3 days. There wasn’t show in-hospital deaths occurred before hospital discharge. During the follow-up, it was observed that 3 patients died from all-cause mortality. The mean follow-up duration of the study was 552 days, with the longest follow-up being 666 days. The significant improvement was noted in all echocardiographic parameters and functional capacity. No cases with moderate or severe aortic regurgitation, necessitating additional procedures. Conclusion Our center results with TAVR over a 2-year span consistent with broader studies. Despite some procedure-related complications, advancements in devices and techniques are expected to reduce these, enhancing outcomes with increased procedural experience. With medicine favoring less invasive approaches, TAVR is poised to become a more prevalent alternative to surgery across diverse patient cohorts.
References
- Lung B, Baron G, Butchart EG, et al. A prospective survey of patients with valvular heart disease in Europe: The Euro Heart Survey on Valvular Heart Disease. Eur Heart J. 2003;24(13):1231-1243. doi:10.1016/s0195-668x(03)00201-x
- Joseph J, Naqvi SY, Giri J, Goldberg S. Aortic Stenosis: Pathophysiology, Diagnosis, and Therapy. Am J Med. 2017;130(3):253-263. doi:10.1016/j.amjmed.2016.10.005
- Alipour MS, Shah PA. Diagnosis of aortic stenosis in the elderly: role of echocardiography. Am J Geriatr Cardiol. 2003;12(3):201-206. doi:10.1111/j.1076-7460.2003.02067.x
- Vahanian A, Beyersdorf F, Praz F, et al. 2021 ESC/EACTS Guidelines for the management of valvular heart disease [published correction appears in Eur Heart J. 2022 Feb 18;:]. Eur Heart J. 2022;43(7):561-632. doi:10.1093/eurheartj/ehab395
- Okumus N, Abraham S, Puri R, Tang WHW. Aortic Valve Disease, Transcatheter Aortic Valve Replacement, and the Heart Failure Patient: A State-of-the-Art Review. JACC Heart Fail. 2023;11(8 Pt 2):1070-1083. doi:10.1016/j.jchf.2023.07.003
- Leon MB, Mack MJ, Hahn RT, et al. Outcomes 2 Years After Transcatheter Aortic Valve Replacement in Patients at Low Surgical Risk. J Am Coll Cardiol. 2021;77(9):1149-1161. doi:10.1016/j.jacc.2020.12.052
- 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):2477-2484. doi:10.1016/S0140-6736(15)60308-7
- Surman TL, Abrahams JM, Williams-Spence J, et al. Clinical Outcomes in Surgical and Transcatheter Aortic Valve Replacement: An ANZSCTS Database Review 2001-2019. Heart Lung Circ. 2022;31(8):1153-1165. doi:10.1016/j.hlc.2022.04.047
- Duran Karaduman B, Ayhan H, Keleş T, Bozkurt E. Evaluation of procedural and clinical outcomes of transcatheter aortic valve implantation: A single-center experience. Tek merkeze ait transkateter aort kapak implantasyonunun işlem ve klinik sonuçların değerlendirilmesi. Anatol J Cardiol. 2020;23(5):288-296. doi:10.14744/AnatolJCardiol.2020.03942
- Tadic M, Sala C, Cuspidi C. The role of TAVR in patients with heart failure: do we have the responses to all questions?. Heart Fail Rev. 2022;27(5):1617-1625. doi:10.1007/s10741-021-10206-6
- Veulemans V, Afzal S, Papadopoulos G, et al. TAVR-related echocardiographic assessment - status quo, challenges and perspectives. Acta Cardiol. 2020;75(4):275-285. doi:10.1080/00015385.2019.1579979
- Zajarias A, Cribier AG. Outcomes and safety of percutaneous aortic valve replacement. J Am Coll Cardiol. 2009;53(20):1829-1836. doi:10.1016/j.jacc.2008.11.059
- Pibarot P, Ternacle J, Jaber WA, et al. Structural Deterioration of Transcatheter Versus Surgical Aortic Valve Bioprostheses in the PARTNER-2 Trial. J Am Coll Cardiol. 2020;76(16):1830-1843. doi:10.1016/j.jacc.2020.08.049
- Case BC, Khan JM, Rogers T. Early Leaflet Thickening, Durability and Bioprosthetic Valve Failure in TAVR. Interv Cardiol Clin. 2021;10(4):531-539. doi:10.1016/j.iccl.2021.05.005
- Takagi H, Umemoto T; ALICE (All-Literature Investigation of Cardiovascular Evidence) Group. Impact of paravalvular aortic regurgitation after transcatheter aortic valve implantation on survival. Int J Cardiol. 2016;221:46-51. doi:10.1016/j.ijcard.2016.07.006
- Lanz J, Möllmann H, Kim WK, et al. Final 3-Year Outcomes of a Randomized Trial Comparing a Self-Expanding to a Balloon-Expandable Transcatheter Aortic Valve. Circ Cardiovasc Interv. 2023;16(7):e012873. doi:10.1161/CIRCINTERVENTIONS.123.012873
- Sa YK, Choi IJ, Chang K, et al. Balloon-Expandable Versus Self-Expandable Valve in Transcatheter Aortic Valve Replacement: A Nation-Wide Study. Am J Cardiol. 2024;213:119-125. doi:10.1016/j.amjcard.2023.12.007
- Sammour Y, Krishnaswamy A, Kumar A, et al. Incidence, Predictors, and Implications of Permanent Pacemaker Requirement After Transcatheter Aortic Valve Replacement. JACC Cardiovasc Interv. 2021;14(2):115-134. doi:10.1016/j.jcin.2020.09.063
- Van Mieghem NM, Tchetche D, Chieffo A, et al. Incidence, predictors, and implications of access site complications with transfemoral transcatheter aortic valve implantation. Am J Cardiol. 2012;110(9):1361-1367. doi:10.1016/j.amjcard.2012.06.042
- Haussig S, Linke A. Patient selection for TAVI 2015 - TAVI in low-risk patients: fact or fiction? EuroIntervention. 2015;11 Suppl W:W86-W91. doi:10.4244/EIJV11SWA27
- Thogata H, Garikipati S, Reddy S S, Abhinav Reddy P, Kumar Jella H. Long-Term Prognosis and Predictors of Mortality in Patients Undergoing Transcatheter Aortic Valve Replacement: A Retrospective Analysis. Cureus. 2023;15(8):e44432. Published 2023 Aug 31. doi:10.7759/cureus.44432
- Seiffert M, Conradi L, Baldus S, et al. Severe intraprocedural complications after transcatheter aortic valve implantation: calling for a heart team approach. Eur J Cardiothorac Surg. 2013;44(3):478-484. doi:10.1093/ejcts/ezt032
- Uguz E, Gokcimen M, Ali S, et al. Predictability and Outcome of Vascular Complications after Transfemoral Transcatheter Aortic Valve Implantation. J Heart Valve Dis. 2016;25(2):173-181.
- O'Leary JM, Clavel MA, Chen S, et al. Association of Natriuretic Peptide Levels After Transcatheter Aortic Valve Replacement With Subsequent Clinical Outcomes. JAMA Cardiol. 2020;5(10):1113-1123. doi:10.1001/jamacardio.2020.2614
Şiddetli Aort Darlığında Tersiyer Bir Merkezde Yapılan Transkateter Aort Kapak Replasmanının İki Yıllık Sonuçları
Abstract
Amaç Aort darlığı (AD), özellikle gelişmiş ülkelerde müdahale gerektiren en yaygın kapak hastalığıdır. Transkateter aort kapak replasmanı (TAVR), yüksek cerrahi risk taşıyan ve işlem sonrası 12 aydan fazla sağkalım beklentisi olan hastalarda endikedir. Yıllar içinde, TAVR yöntemi semptomatik ciddi AD'li hastalar için önemli bir tedavi seçeneği olarak ortaya çıkmış ve ülkemizde de uygulanmaya başlanmıştır. Bu çalışmanın amacı, merkezimizde TAVR geçiren hastaların kısa ve uzun vadeli sonuçlarını değerlendirmek ve TAVR prosedürü ile kurum deneyimimizi değerlendirmektir. Yöntem Bu retrospektif, tek merkezli analiz, Mart 2022 ile Şubat 2024 arasında TAVR geçiren 16 ardışık semptomatik AD'li hastayı içerdi. Çalışmaya dahil edilen tüm hastalar, balon genişletilebilir bir TAVR kapak implantasyonu geçirdi. Çalışmada, hastaların preoperatif ve postoperatif takiplerinde demografik özellikleri, klinik durumları ve ekokardiyografik bulguları değerlendirilip karşılaştırıldı. Bulgular Tüm popülasyonun ortalama yaşı 78.3 ± 8.7 yıl idi ve %50'si kadındı. Hastaların %93.8'inde transfemoral erişim kullanıldı. İmplantasyon başarısı tüm vakalarda sağlandı. TAVI işlemi sırasında hastaların %12.5'ine kalıcı kalp pili implantasyonu gerekti. Tüm kohort için hastanede kalış süresinin ortalama uzunluğu 4.5 ± 2.3 gün idi. Hastane taburculuğundan önce hiçbir hastanede ölüm olmadı. Takip sırasında, 3 hastanın tüm nedenlere bağlı olarak öldüğü görüldü. Çalışmanın ortalama takip süresi 552 gün olup, en uzun takip süresi 666 gündü. Tüm ekokardiyografik parametrelerde ve fonksiyonel kapasitede belirgin bir iyileşme gözlendi. Ek prosedür gerektiren orta veya şiddetli aort yetersizliği vakası bulunmadı. Sonuç Merkezimizdeki TAVR sonuçları, daha geniş çalışmalarla tutarlıdır. Bazı prosedürle ilgili komplikasyonlara rağmen, cihaz ve tekniklerdeki ilerlemelerin bunları azaltması ve prosedür deneyimi arttıkça sonuçların geliştirilmesi beklenmektedir. Tıbbın daha az invaziv yaklaşımları tercih etmesiyle, TAVR'in farklı hasta grupları arasında cerrahiye alternatif olarak daha yaygın bir seçenek haline gelmesi beklenmektedir.
References
- Lung B, Baron G, Butchart EG, et al. A prospective survey of patients with valvular heart disease in Europe: The Euro Heart Survey on Valvular Heart Disease. Eur Heart J. 2003;24(13):1231-1243. doi:10.1016/s0195-668x(03)00201-x
- Joseph J, Naqvi SY, Giri J, Goldberg S. Aortic Stenosis: Pathophysiology, Diagnosis, and Therapy. Am J Med. 2017;130(3):253-263. doi:10.1016/j.amjmed.2016.10.005
- Alipour MS, Shah PA. Diagnosis of aortic stenosis in the elderly: role of echocardiography. Am J Geriatr Cardiol. 2003;12(3):201-206. doi:10.1111/j.1076-7460.2003.02067.x
- Vahanian A, Beyersdorf F, Praz F, et al. 2021 ESC/EACTS Guidelines for the management of valvular heart disease [published correction appears in Eur Heart J. 2022 Feb 18;:]. Eur Heart J. 2022;43(7):561-632. doi:10.1093/eurheartj/ehab395
- Okumus N, Abraham S, Puri R, Tang WHW. Aortic Valve Disease, Transcatheter Aortic Valve Replacement, and the Heart Failure Patient: A State-of-the-Art Review. JACC Heart Fail. 2023;11(8 Pt 2):1070-1083. doi:10.1016/j.jchf.2023.07.003
- Leon MB, Mack MJ, Hahn RT, et al. Outcomes 2 Years After Transcatheter Aortic Valve Replacement in Patients at Low Surgical Risk. J Am Coll Cardiol. 2021;77(9):1149-1161. doi:10.1016/j.jacc.2020.12.052
- 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):2477-2484. doi:10.1016/S0140-6736(15)60308-7
- Surman TL, Abrahams JM, Williams-Spence J, et al. Clinical Outcomes in Surgical and Transcatheter Aortic Valve Replacement: An ANZSCTS Database Review 2001-2019. Heart Lung Circ. 2022;31(8):1153-1165. doi:10.1016/j.hlc.2022.04.047
- Duran Karaduman B, Ayhan H, Keleş T, Bozkurt E. Evaluation of procedural and clinical outcomes of transcatheter aortic valve implantation: A single-center experience. Tek merkeze ait transkateter aort kapak implantasyonunun işlem ve klinik sonuçların değerlendirilmesi. Anatol J Cardiol. 2020;23(5):288-296. doi:10.14744/AnatolJCardiol.2020.03942
- Tadic M, Sala C, Cuspidi C. The role of TAVR in patients with heart failure: do we have the responses to all questions?. Heart Fail Rev. 2022;27(5):1617-1625. doi:10.1007/s10741-021-10206-6
- Veulemans V, Afzal S, Papadopoulos G, et al. TAVR-related echocardiographic assessment - status quo, challenges and perspectives. Acta Cardiol. 2020;75(4):275-285. doi:10.1080/00015385.2019.1579979
- Zajarias A, Cribier AG. Outcomes and safety of percutaneous aortic valve replacement. J Am Coll Cardiol. 2009;53(20):1829-1836. doi:10.1016/j.jacc.2008.11.059
- Pibarot P, Ternacle J, Jaber WA, et al. Structural Deterioration of Transcatheter Versus Surgical Aortic Valve Bioprostheses in the PARTNER-2 Trial. J Am Coll Cardiol. 2020;76(16):1830-1843. doi:10.1016/j.jacc.2020.08.049
- Case BC, Khan JM, Rogers T. Early Leaflet Thickening, Durability and Bioprosthetic Valve Failure in TAVR. Interv Cardiol Clin. 2021;10(4):531-539. doi:10.1016/j.iccl.2021.05.005
- Takagi H, Umemoto T; ALICE (All-Literature Investigation of Cardiovascular Evidence) Group. Impact of paravalvular aortic regurgitation after transcatheter aortic valve implantation on survival. Int J Cardiol. 2016;221:46-51. doi:10.1016/j.ijcard.2016.07.006
- Lanz J, Möllmann H, Kim WK, et al. Final 3-Year Outcomes of a Randomized Trial Comparing a Self-Expanding to a Balloon-Expandable Transcatheter Aortic Valve. Circ Cardiovasc Interv. 2023;16(7):e012873. doi:10.1161/CIRCINTERVENTIONS.123.012873
- Sa YK, Choi IJ, Chang K, et al. Balloon-Expandable Versus Self-Expandable Valve in Transcatheter Aortic Valve Replacement: A Nation-Wide Study. Am J Cardiol. 2024;213:119-125. doi:10.1016/j.amjcard.2023.12.007
- Sammour Y, Krishnaswamy A, Kumar A, et al. Incidence, Predictors, and Implications of Permanent Pacemaker Requirement After Transcatheter Aortic Valve Replacement. JACC Cardiovasc Interv. 2021;14(2):115-134. doi:10.1016/j.jcin.2020.09.063
- Van Mieghem NM, Tchetche D, Chieffo A, et al. Incidence, predictors, and implications of access site complications with transfemoral transcatheter aortic valve implantation. Am J Cardiol. 2012;110(9):1361-1367. doi:10.1016/j.amjcard.2012.06.042
- Haussig S, Linke A. Patient selection for TAVI 2015 - TAVI in low-risk patients: fact or fiction? EuroIntervention. 2015;11 Suppl W:W86-W91. doi:10.4244/EIJV11SWA27
- Thogata H, Garikipati S, Reddy S S, Abhinav Reddy P, Kumar Jella H. Long-Term Prognosis and Predictors of Mortality in Patients Undergoing Transcatheter Aortic Valve Replacement: A Retrospective Analysis. Cureus. 2023;15(8):e44432. Published 2023 Aug 31. doi:10.7759/cureus.44432
- Seiffert M, Conradi L, Baldus S, et al. Severe intraprocedural complications after transcatheter aortic valve implantation: calling for a heart team approach. Eur J Cardiothorac Surg. 2013;44(3):478-484. doi:10.1093/ejcts/ezt032
- Uguz E, Gokcimen M, Ali S, et al. Predictability and Outcome of Vascular Complications after Transfemoral Transcatheter Aortic Valve Implantation. J Heart Valve Dis. 2016;25(2):173-181.
- O'Leary JM, Clavel MA, Chen S, et al. Association of Natriuretic Peptide Levels After Transcatheter Aortic Valve Replacement With Subsequent Clinical Outcomes. JAMA Cardiol. 2020;5(10):1113-1123. doi:10.1001/jamacardio.2020.2614
Details
| Primary Language | English |
|---|---|
| Subjects | Health Services and Systems (Other) |
| Journal Section | Research Article |
| Authors | |
| Publication Date | June 29, 2024 |
| Submission Date | April 29, 2024 |
| Acceptance Date | June 8, 2024 |
| Published in Issue | Year 2024Volume: 46 Issue: 2 |
