European Journal of Cardiovascular Medicine

Aortic stenosis (AS) is an athero-degenerative, potentially life-threatening disease, predominantly involving the elderly, with obstruction of left ventricular outflow by calcification of the aortic valve. Traditional surgical aortic valve replacement (SAVR) has been the gold standard definitive therapy. Transcatheter aortic valve replacement (TAVR) has changed the treatment paradigm, with a less invasive therapy having expanding indications from high- and intermediate-risk patients to now even in low-risk patients (Søndergaard et al., 2016) [5].

TAVR, once limited to inoperable or prohibitive surgical risk patients, has improved enormously in device technology, technique of the procedure, and management post-procedure. Such development has made possible the use of TAVR across a greater number of patient populations. Outcomes at both short and mid-term intervals even among low-risk surgical patients have been proven through randomized controlled trials and registry findings in recent years, with similar if not better outcomes with SAVR with regards to mortality, stroke, and time of recovery (Søndergaard et al., 2016; Elgendy et al., 2019) [5,8]. While numerous trials have evaluated TAVR in urgent or emergent situations, often under minimalist or expeditious procedural schedules, the applicability of these results to low-risk patients undergoing elective procedures has to be questioned with caution. Berkovitch et al. (2022) [1], for instance, have described outcomes of expedited TAVR with added procedural risk but acceptable late outcomes when managed with caution. Ichibori et al. (2019) [2] also demonstrated that minimalist urgent TAVR would be linked with acceptable late outcomes and made remarks on the procedural flexibility and TAVR safety profile in suboptimal clinical situations. Kolte et al. (2018) [3], in reporting on STS/ACC TVT Registry, also defined heterogeneity of outcome by dividing patients into procedural urgency strata and mentioned that while urgent/emergent procedures were predictive of higher immediate risk, long-term outcome might still be favorable, especially with optimized periprocedural management. In addition, some echocardiographic indices such as the left atrial function index (LAFI) have been analyzed as long-term outcome predictors after TAVR, as shown by Shamekhi et al. (2022) [4], again highlighting personalized risk stratification.

Comparison between self-expanding TAVR and SAVR has also given evidence on complication patterns and trends in recovery. Conte et al. (2017) [6] recognized certain patterns of complications between modalities that are relevant to procedural planning and patient choice. Moreover, the complex patient groups such as nonagenarians and cancer patients—historically underrepresented in clinical trials—have also shown acceptable results with TAVR, as observed by the studies of Elgendy et al. (2019) [8] and Landes et al. (2019 [7] respectively, to pave its entry into different clinical settings.

Despite this growing body of evidence, however, there has been a relative lack of strong data specifically regarding the long-term results of low-risk patients undergoing TAVR. As the population indications for TAVR continue to expand, it becomes increasingly important to study its long-term safety, durability, and effectiveness in this increasingly prevalent subgroup. The purpose of this study is to assist in closing this information gap by directly comparing procedural and long-term results in low-risk patients undergoing TAVR to aid in the formation of the evidence base necessary for optimal clinical decision-making and guideline recommendations in this group.

This was a prospective, observational cohort study from the Department of Cardiology, Rajshree Medical College, Rajshree Group of Institutions and Hospital, Bareilly, Uttar Pradesh, India. The research was conducted during a duration of 4 years from January 2020 through December 2023. Ethical clearance had been obtained from the Institutional Ethics Committee prior to starting the study, and informed consent had been obtained from all the participants.

Study Population

As part of this study, we followed subjects with clinically symptomatic severe aortic stenosis who received TAVR at our center during the study period. Only enrollees with STS-PROM <4% were selected for inclusion. Other inclusion criteria were: age 60 years or older, left ventricular ejection fraction (LVEF) ≥ 40%, and capacity to give informed consent. Patients were excluded if they had a bicuspid valve, anatomic or functional factors requiring other concomitant significant valvular surgery, previous valve surgery, or major associated comorbidities like advanced cancer.

Procedural Information

An interventional cardiologist, cardiac surgeon, anesthetist, and imaging specialist formed the experienced multidisciplinary heart team that performed every procedure within the hybrid cardiac catheterization lab. All TAVR procedures were successfully performed on a majority of patients through transfemoral access and both balloon-expandable and self-expanding valves were used based on clinical parameters as well as anatomical ones. Modern practice patterns for lower risk patients were followed by most cases which used a minimalist approach with sedation and echocardiographic guidance during the procedure (Ichibori et al., 2019). Imaging performed prior to the procedure included transthoracic echocardiography, multi-slice CT for annulus scaling, and coronary angiography.

Data Collection

Patients’ demographics, clinical presentation, echocardiogram details, procedural metrics, and in-hospital outcomes were obtained prospectively. STS-PROM scores were derived for risk stratification. Data for 1 month, 6 months, 1 year, and then annually for 3 years were counted as post-procedure follow-up GP data. Follow-up included physical examination, ECG, TTE, and structured phone interviews.

Outcome Measures

Primary endpoint was all-cause mortality at 3 years. Secondary endpoints included cardiovascular death, stroke, requirement for pacemaker implantation, readmission due to heart failure, paravalvular regurgitation, valve performance (assessed by gradient and regurgitation), and quality of life measured with the Kansas City Cardiomyopathy Questionnaire (KCCQ). Statistical Analysis Continuous variables were expressed as mean ± SD or median with IQR, according to distribution. Categorical variables were expressed as counts and percentages. Survival was calculated by Kaplan-Meier, and between-group comparisons were done by the log-rank test. Multivariate Cox proportional hazards regression was applied to identify predictors of long-term mortality and adverse outcome. A p-value of <0.05 was considered to determine significance. Data analysis was performed on SPSS software version 25.0 (IBM Corp., Armonk, NY, USA).

Baseline Demographics and Clinical Characteristics

A total of 124 patients who had TAVR from January 2020 to December 2023 were enrolled in the study. The mean age was 70.6 ± 6.8 years, and 57.2% (n = 71) were male. All the patients were diagnosed with severe symptomatic aortic stenosis and had low-risk criteria with a mean STS-PROM score of 2.1 ± 0.7%. The most frequent comorbidities were hypertension (62.1%), diabetes mellitus (39.5%), and coronary artery disease (28.2%). The average left ventricular ejection fraction (LVEF) was 54.2 ± 6.3%. The majority of procedures were done through the transfemoral approach under conscious sedation (92.7%). Table 1 summarizes the baseline characteristics of the study population.

Table 1: Baseline Demographic and Clinical Characteristics (n = 124)

Procedural and In-Hospital Outcomes

Procedural success was obtained in 98.4% (n = 122) of patients. The average procedure time was 68 ± 14 minutes, and the average hospital stay was 4.8 ± 1.3 days. In-hospital complications were permanent pacemaker implantation in 6.5%, major vascular complications in 2.4%, and stroke in 1.6%.

No in-hospital mortality was seen. The majority of patients had immediate symptomatic relief and were discharged in NYHA Class I or II. Table 2 shows procedural and in-hospital results.

Table 2: Procedural and In-Hospital Outcomes

Long-Term Outcomes and Survival Analysis

The median follow-up time was 28 months (IQR: 18–36 months). All-cause mortality at 1 and 3 years was 2.4% and 5.6%, respectively. Cardiovascular mortality was responsible for 4 out of 7 deaths. Rehospitalization due to heart failure was seen in 7.2% of patients, and moderate paravalvular leak was seen in 5.6%. Most patients (88%) had functional improvement (NYHA Class I/II) at follow-up.

Valve hemodynamics were intact with no instances of structural valve deterioration reported during the study course.

Summary of Key Findings

In this prospective low-risk patient study of transcatheter aortic valve replacement (TAVR) at Rajshree Medical College, the results showed excellent procedural results and long-term durability. The procedural success rate was high, with few periprocedural complications and no in-hospital mortality. At a median follow-up of 28 months, three-year survival rate was more than 94%, and most patients had persistent improvement in functional status, from NYHA Class III/IV to Class I/II. Stroke, pacemaker implantation, and rehospitalization rates were low and in line with worldwide TAVR experience in similar populations. Significantly, there was no valve structural deterioration or major loss of valve function during follow-up, highlighting the safety and effectiveness of TAVR in properly selected low-risk patients.

The focus of this study is the evaluation of the long-term outcomes of TAVR in lower risk patients at a tertiary care hospital in North India. Our data indicates that TAVR in this cohort is associated with excellent achievement of all defined milestones, low complication rates, and favorable long-term survival and functional enhancement. The three year survival was 94%, with over 85% of the patients maintaining NYHA Class I/II status. These observations reinforce the rapidly increasing paradigm shift for TAVR utilization in patients older than just high and intermediate risk groups. 

When juxtaposing these results with other published reports, the data agrees with the global accepted movement toward more liberal application of TAVR for broader clinical indications. As an example, Little et al. (2016) [9] reported satisfactory hemodynamic and functional outcomes in high risk patients who were self-expanding TAVR compared to SAVR, supporting that catheter-based intervention yields sustainable outcomes in anatomically and physiologically complex cases. In our cohort which was low risk, the strong hemodynamic performance along with low complications over time is consistent with these results, especially with regard to valve durability and minimal structural deterioration.

Whenever some additional comorbidities like coronary artery disease (CAD) are considered, decision-making remains tough. Baumbach et al. (2019) [10] also emphasized the challenges of concomitant CAD and aortic stenosis, highlighting the value of hybrid catheter-based interventions. In this study, 28.2% of patients presented with stable CAD and underwent percutaneous coronary intervention (PCI) when it was deemed necessary either before or simultaneous with TAVR. This represents an integrated, minimally invasive approach for the patients since they stand to have increased perioperative risks with SAVR. Another relevant point is the increasing acceptance of TAVR in special populations like patients with malignancy. Guha et al. (2020) [11] and Murphy et al. (2021) [15] analyzed outcomes among oncology patients and wrote that TAVR had equivalent or better results compared to surgery in terms of mortality and functional recovery. Even though cancer patients were not included in our cohort, the observation of these studies validates that TAVR can be an effective long-term therapy in populations hitherto defined as high-risk for surgery.

Right ventricular (RV) failure has also raised concern after TAVR, as noted in a meta-analysis conducted by Grevious et al. (2020) [12], which created an association of baseline RV failure with short-term adverse outcomes. In our investigation, patients with moderate or severe RV dysfunction were excluded to ensure homogeneity, but the resultant overall low incidence of right heart failure and preserved post-procedure function may indirectly indicate the advantage of meticulous pre-procedure patient selection in ensuring maximal outcomes.

Access route continues to be another very important determinant of procedural success and rate of complications. The transfemoral approach, employed in more than 92% of our patients, is most free of procedural morbidity and most favorable in recovery outcomes, such as demonstrated by Damluji et al. (2018) [13], who concluded that transfemoral access is the best option for elderly patients when it can be performed. Our results also confirm this, with low rates of vascular complications (2.4%) and zero access-related mortality, further supporting the guideline preference for transfemoral TAVR when anatomic suitability allows.

With regard to myocardial damage during the procedure, Stundl et al. (2017) [14] concluded that valve type could have some impact on the extent of myocardial damage but not for long-term mortality. Both self-expanding and balloon-expandable valves were used in our experience without detecting major differences in short-term myocardial impairment or long-term mortality, though the study was not necessarily powered for subgroup valve-type analysis. Together, our data highlight that with proper patient selection, imaging guidance, and procedural planning, TAVR among low-risk populations provides outcomes that are not only equivalent but in most instances superior to conventional surgical approaches. The findings also indicate consistency with earlier research in different patient populations, indicating that TAVR is becoming a first-line treatment of choice for aortic stenosis, not only in the elderly or high-risk but also in carefully selected low-risk patients with favorable anatomy and comorbidity profiles. Nevertheless, although our data are encouraging, the single-site and limited cohort nature present certain constraints, and durability beyond 3 years still needs to be established fully. Multicenter trials and extended follow-up will be needed to confirm these observations and to define comparative effectiveness of alternative TAVR platforms versus surgical approaches across larger low-risk populations.

This research proves that transcatheter aortic valve replacement (TAVR) is a very effective and safe treatment for patients with severe aortic stenosis who fall in the low-risk category. Being performed at Rajshree Medical College, the outcomes show tremendous procedural success, very few peri-procedural complications, marked improvement in functional status, and long-term survival across a three-year follow-up period. The results reaffirm the increasingly robust evidence base for the use of TAVR in populations lower than high risk, suggesting its validity as a first-line therapy in properly selected low-risk patients. Ongoing follow-up and larger multicenter trials are needed to further assess valve durability and long-term clinical events in this increasingly broadened patient population.

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2.       Ichibori Y, Li J, Patel T, et al. Short-Term and Long-Term Outcomes of Patients Undergoing Urgent Transcatheter Aortic Valve Replacement Under a Minimalist Strategy. J Invasive Cardiol. 2019;31(2):E30-E36. doi:10.25270/jic/18.00221

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4.       Shamekhi J, Nguyen TQA, Sigel H, et al. Left atrial function index (LAFI) and outcome in patients undergoing transcatheter aortic valve replacement. Clin Res Cardiol. 2022;111(8):944-954. doi:10.1007/s00392-022-02010-5

5.       Søndergaard L, Steinbrüchel DA, Ihlemann N, et al. Two-Year Outcomes in Patients With Severe Aortic Valve Stenosis Randomized to Transcatheter Versus Surgical Aortic Valve Replacement: The All-Comers Nordic Aortic Valve Intervention Randomized Clinical Trial. Circ Cardiovasc Interv. 2016;9(6):e003665. doi:10.1161/CIRCINTERVENTIONS.115.003665

6.       Conte JV, Hermiller J Jr, Resar JR, et al. Complications After Self-expanding Transcatheter or Surgical Aortic Valve Replacement. Semin Thorac Cardiovasc Surg. 2017;29(3):321-330. doi:10.1053/j.semtcvs.2017.06.001

7.       Landes U, Iakobishvili Z, Vronsky D, et al. Transcatheter Aortic Valve Replacement in Oncology Patients With Severe Aortic Stenosis. JACC Cardiovasc Interv. 2019;12(1):78-86. doi:10.1016/j.jcin.2018.10.026

8.       Elgendy IY, Mahmoud AN, Elbadawi A, et al. In-hospital outcomes of transcatheter versus surgical aortic valve replacement for nonagenarians. Catheter Cardiovasc Interv. 2019;93(5):989-995. doi:10.1002/ccd.28050

9.       Little SH, Oh JK, Gillam L, et al. Self-Expanding Transcatheter Aortic Valve Replacement Versus Surgical Valve Replacement in Patients at High Risk for Surgery: A Study of Echocardiographic Change and Risk Prediction. Circ Cardiovasc Interv. 2016;9(6):e003426. doi:10.1161/CIRCINTERVENTIONS.115.003426

10.    Baumbach H, Schairer ER, Wachter K, et al. Transcatheter aortic valve replacement- management of patients with significant coronary artery disease undergoing aortic valve interventions: surgical compared to catheter-based approaches in hybrid procedures. BMC Cardiovasc Disord. 2019;19(1):108. Published 2019 May 14. doi:10.1186/s12872-019-1087-2

11.    Guha A, Dey AK, Arora S, et al. Contemporary Trends and Outcomes of Percutaneous and Surgical Aortic Valve Replacement in Patients With Cancer. J Am Heart Assoc. 2020;9(2):e014248. doi:10.1161/JAHA.119.014248

12.    Grevious SN, Fernandes MF, Annor AK, et al. Prognostic Assessment of Right Ventricular Systolic Dysfunction on Post-Transcatheter Aortic Valve Replacement Short-Term Outcomes: Systematic Review and Meta-Analysis. J Am Heart Assoc. 2020;9(12):e014463. doi:10.1161/JAHA.119.014463

13.    Damluji AA, Murman M, Byun S, et al. Alternative access for transcatheter aortic valve replacement in older adults: A collaborative study from France and United States. Catheter Cardiovasc Interv. 2018;92(6):1182-1193. doi:10.1002/ccd.27690

14.    Stundl A, Schulte R, Lucht H, et al. Periprocedural Myocardial Injury Depends on Transcatheter Heart Valve Type But Does Not Predict Mortality in Patients After Transcatheter Aortic Valve Replacement. JACC Cardiovasc Interv. 2017;10(15):1550-1560. doi:10.1016/j.jcin.2017.05.029

15.    Murphy AC, Koshy AN, Cameron W, et al. Transcatheter aortic valve replacement in patients with a history of cancer: Periprocedural and long-term outcomes. Catheter Cardiovasc Interv. 2021;97(1):157-164. doi:10.1002/ccd.28969