Gender differences in patients undergoing transcatheter aortic valve replacement: a cross-sectional study

Yıl 2022, , 285 - 292, 31.12.2022

Adem Aktan , Faruk Ertaş

https://doi.org/10.30565/medalanya.1177186

Cited By: 1

Öz

Aim: Transcatheter aortic valve replacement (TAVR) is an effective treatment modality for patients with high-risk symptomatic severe aortic stenosis (AS) who are not suitable for surgery. Gender-related differences in TAVR are still deliberated, thus in this study we aimed to investigate the effect of gender on clinical outcomes in patients who underwent TAVR in our clinic.

Methods: 270 consecutive patients who underwent TAVR between January 2015 and January 2022 were included in the study. In addition to the patient's medical history, transthoracic or transesophageal echocardiography and computed tomography findings were examined to evaluate AS. Patients with symptomatic, high-risk severe aortic stenosis were treated with self-expanding Evolute-R devices. The patients were followed up for the first year after discharge. Follow-up was done by clinical visits and phone calls.

Results: In-hospital mortality (5.4% vs. 7.4%; p=0.507), death at one-year follow-up (14.9% vs. 13.1%, p=0.681), and major adverse cardiovascular and cerebrovascular events (MACCE) at one-year follow-up (26.4% versus 23.8%, p =0.627) rates, there was no statistically significant difference between male and female genders. Kaplan Meier curves were used for survival analysis, including one-year mortality and MACCE rates. Accordingly, no statistically significant difference was found between the two genders in terms of mortality and MACCE (respectively; p= 0.910; p=0.889).

Conclusion: In our patient group who underwent TAVR, we could not detect a significant difference in clinical outcomes between both genders. In recent years, the effect of gender on clinical outcomes may decrease with device and procedural developments.

Anahtar Kelimeler

Aortic stenosis, gender, mortality, transcatheter aortic valve replacement

Transkateter Aort Kapak Replasmanı Uygulanan Hastalarda Cinsiyet Farklılıkları: Kesitsel Bir Çalışma

Öz

Amaç: Transkateter aort kapak replasmanının (TAVR) cerrahiye uygun olmayan, yüksek riskli semptomatik şiddetli aort darlığı (AS) olan hastalar için etkili bir tedavi yöntemidir. TAVR’da cinsiyete bağlı farklılıklar hala tartışılmaktadır. Bu çalışma ile kliniğimizde TAVR uygulanan hastalarda cinsiyetin klinik sonuçlar üzerine etkisini araştırmayı amaçladık.

Yöntemler: Ocak 2015 ile Ocak 2022 tarihleri arasında TAVR yapılan ardışık 270 hasta çalışmaya dahil edildi. AS’yi değerlendirmek için hastanın tıbbi öyküsünün yanı sıra transtorasik veya transözofageal ekokardiyografi ve bilgisayarlı toraks tomografisi bulguları incelendi. Semptomatik, yüksek riskli şiddetli aort darlığı tespit edilen hastalara kendiliğinden genişleyebilen Evolute-R cihazlarıyla işlem yapıldı. Hastalar taburculuk sonrası ilk bir yıl takip edildi. Takipler klinik ziyaretler ve telefon görüşmeleriyle gerçekleşti.

Bulgular: Hastane içi mortalite (%5.4’e karşı %7.4 ; p=0.507), bir yıllık takipte ölüm (%14.9'e karşı %.13.1, p=0.681) ve bir yıllık takipte majör advers kardiyovasküler ve serebrovasküler olaylar (MACCE) (%26.4'e karşı %23.8, p=0.627) oranları açısından kadın ve erkek cinsiyetleri arasında istatistiksel olarak anlamlı farklılık saptanmadı. Bir yıllık mortalite ve MACCE oranlarını içeren sağkalım analizi Kaplan-Meier eğrileri kullanıldı. Buna göre her iki cinsiyet arasında mortalite ve MACCE açısından istatistiksel olarak anlamlı farklılık saptanmadı ( sırasıyla; p= 0.910; p =0.889).

Sonuç: TAVR yapılan hasta grubumuzda her iki cinsiyet arasında klinik sonlanımlar açısından önemli bir farklılık saptayamadık. Son yıllarda cihaz ve prosedürle ilişkili gelişmelerle cinsiyetin klinik sonuçlar üzerine etkisi azaltılmıştır.

Anahtar Kelimeler

Aort darlığı, cinsiyet, mortalite, transkateter aort kapak replasmanı

Kaynakça

• 1. Lung B, Delgado V, Rosenhek R, Price S, Prendergast B, Wendler O, et al. EORP VHD II Investigators. Contemporary Presentation and Management of Valvular Heart Disease: The EURObservational Research Programme Valvular Heart Disease II Survey. Circulation. 2019;140(14):1156-69. doi: 10.1161/CIRCULATIONAHA.119.041080.
• 2. Panoulas VF, Francis DP, Ruparelia N, Malik IS, Chukwuemeka A, Sen S, et al. Female-specific survival advantage from transcatheter aortic valve implantation over surgical aortic valve replacement: Meta-analysis of the gender subgroups of randomised controlled trials including 3758 patients. Int J Cardiol. 2018;250:66-72. doi: 10.1016/j.ijcard.2017.05.047.
• 3. Pancholy SB, Shantha GP, Patel T, Cheskin LJ. Sex differences in short-term and long-term all-cause mortality among patients with ST-segment elevation myocardial infarction treated by primary percutaneous intervention: a meta-analysis. JAMA Intern Med. 2014;174(11):1822-30. doi: 10.1001/jamainternmed.2014.4762.
• 4. Swaminathan RV, Feldman DN, Pashun RA, Patil RK, Shah T, Geleris JD, et al. Gender Differences in In-Hospital Outcomes After Coronary Artery Bypass Grafting. Am J Cardiol. 2016;118(3):362-8. doi: 10.1016/j.amjcard.2016.05.004.
• 5. Kaiser DW, Fan J, Schmitt S, Than CT, Ullal AJ, Piccini JP, et al. Gender Differences in Clinical Outcomes after Catheter Ablation of Atrial Fibrillation. JACC Clin Electrophysiol. 2016;2(6):703-10. doi: 10.1016/j.jacep.2016.04.014.
• 6. Demir M, Özbek M, Polat N, Aktan A, Yıldırım B, Argun L, et al. Trend of Sex Differences and Predictors of Complications of Cardiac Electronic Device Implantations in the Southeast Anatolian Region of Turkey: An Observational Study. European Journal of Therapeutics. 2022;28:151-7. doi: 10.54614/eurjther.2022.0030.
• 7. Leon MB, Smith CR, Mack MJ, Makkar RR, Svensson LG, Kodali SK, et al. PARTNER 2 Investigators. Transcatheter or Surgical Aortic-Valve Replacement in Intermediate-Risk Patients. N Engl J Med. 2016;374(17):1609-20. doi: 10.1056/NEJMoa1514616.
• 8. Mack MJ, Leon MB, Thourani VH, Makkar R, Kodali SK, Russo M, et al. PARTNER 3 Investigators. Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients. N Engl J Med. 2019;380(18):1695-1705. doi: 10.1056/NEJMoa1814052.
• 9. Popma JJ, Deeb GM, Yakubov SJ, Mumtaz M, Gada H, O'Hair D, et al. Evolut Low Risk Trial Investigators. Transcatheter Aortic-Valve Replacement with a Self-Expanding Valve in Low-Risk Patients. N Engl J Med. 2019;380(18):1706-15. doi: 10.1056/NEJMoa1816885.
• 10. Williams M, Kodali SK, Hahn RT, Humphries KH, Nkomo VT, Cohen DJ, et al. Sex-related differences in outcomes after transcatheter or surgical aortic valve replacement in patients with severe aortic stenosis: Insights from the PARTNER Trial (Placement of Aortic Transcatheter Valve). J Am Coll Cardiol. 2014;63(15):1522-8. doi: 10.1016/j.jacc.2014.01.036.
• 11. Itchhaporia D. Transcatheter aortic valve replacement in women. Clin Cardiol. 2018;41(2):228-31. doi: 10.1002/clc.22912.
• 12. O'Brien SM, Shahian DM, Filardo G, Ferraris VA, Haan CK, Rich JB, et al. Society of Thoracic Surgeons Quality Measurement Task Force. The Society of Thoracic Surgeons 2008 cardiac surgery risk models: part 2--isolated valve surgery. Ann Thorac Surg. 2009;88(1 Suppl):S23-42. doi: 10.1016/j.athoracsur.2009.05.056.
• 13. Al-Lamee R, Broyd C, Parker J, Davies JE, Mayet J, Sutaria N, et al. Influence of gender on clinical outcomes following transcatheter aortic valve implantation from the UK transcatheter aortic valve implantation registry and the National Institute for Cardiovascular Outcomes Research. Am J Cardiol. 2014;113(3):522-8. doi: 10.1016/j.amjcard.2013.10.024.
• 14. Kodali S, Williams MR, Doshi D, Hahn RT, Humphries KH, Nkomo VT, et al. Sex-Specific Differences at Presentation and Outcomes Among Patients Undergoing Transcatheter Aortic Valve Replacement: A Cohort Study. Ann Intern Med. 2016;164(6):377-84. doi: 10.7326/M15-0121.
• 15. Smith CR, Leon MB, Mack MJ, Miller DC, Moses JW, Svensson LG, et al. PARTNER Trial Investigators. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med. 2011;364(23):2187-98. doi: 10.1056/NEJMoa1103510.
• 16. O'Connor SA, Morice MC, Gilard M, Leon MB, Webb JG, Dvir D, et al. Revisiting Sex Equality With Transcatheter Aortic Valve Replacement Outcomes: A Collaborative, Patient-Level Meta-Analysis of 11,310 Patients. J Am Coll Cardiol. 2015;66(3):221-8. doi: 10.1016/j.jacc.2015.05.024.
• 17. Günlü S, Demir M. Comparison of tenecteplase versus alteplase in STEMI patients treated with ticagrelor: A cross-sectional study. Am J Emerg Med. 2022;58:52-6. doi: 10.1016/j.ajem.2022.05.021.
• 18. Laricchia A, Bellini B, Romano V, Khawaja S, Montorfano M, Chieffo A. Sex and Transcatheter Aortic Valve Implantation: Impact of Female Sex on Clinical Outcomes. Interv Cardiol. 2019;14(3):137-41. doi: 10.15420/icr.2019.07.R1.
• 19. Masiero G, Paradies V, Franzone A, Bellini B, Biase CD, Karam N et al. TAVI spesific sex consideration. Mini-invasive Surg. 2022;6(4):1-19. doi: 10.20517/2574-1225.2021.104
• 20. Saad M, Nairooz R, Pothineni NVK, Almomani A, Kovelamudi S, Sardar P, et al. Long-Term Outcomes With Transcatheter Aortic Valve Replacement in Women Compared With Men: Evidence From a Meta-Analysis. JACC Cardiovasc Interv. 2018;11(1):24-35. doi: 10.1016/j.jcin.2017.08.015.
• 21. Szerlip M, Gualano S, Holper E, Squiers JJ, White JM, Doshi D, et al. Sex-Specific Outcomes of Transcatheter Aortic Valve Replacement With the SAPIEN 3 Valve: Insights From the PARTNER II S3 High-Risk and Intermediate-Risk Cohorts. JACC Cardiovasc Interv. 2018;11(1):13-20. doi: 10.1016/j.jcin.2017.09.035.
• 22. Ribeiro HB, Webb JG, Makkar RR, Cohen MG, Kapadia SR, Kodali S, et al. Predictive factors, management, and clinical outcomes of coronary obstruction following transcatheter aortic valve implantation: insights from a large multicenter registry. J Am Coll Cardiol. 2013;62(17):1552-62. doi: 10.1016/j.jacc.2013.07.040.
• 23. Holmes DR Jr, Brennan JM, Rumsfeld JS, Dai D, O'Brien SM, Vemulapalli S, et al. STS/ACC TVT Registry. Clinical outcomes at 1 year following transcatheter aortic valve replacement. JAMA. 2015;313(10):1019-28. doi: 10.1001/jama.2015.1474.
• 24. Chieffo A, Petronio AS, Mehilli J, Chandrasekhar J, Sartori S, et al. WIN-TAVI Investigators. Acute and 30-Day Outcomes in Women After TAVR: Results From the WIN-TAVI (Women's INternational Transcatheter Aortic Valve Implantation) Real-World Registry. JACC Cardiovasc Interv. 2016;9(15):1589-600. doi: 10.1016/j.jcin.2016.05.015.
• 25. Ferrante G, Pagnotta P, Petronio AS, Bedogni F, Brambilla N, Fiorina C, et al. Sex differences in postprocedural aortic regurgitation and mid-term mortality after transcatheter aortic valve implantation. Catheter Cardiovasc Interv. 2014;84(2):264-71. doi: 10.1002/ccd.25377.