Transcatheter Aortic Valve Replacement Program Research Articles

Transfemoral-only transcatheter aortic valve replacement: A single center experience of 400 consecutive patients.

In transcatheter aortic valve replacement (TAVR),transfemoral (TF) access offers several advantages over alternative access routes. Advances in sheaths and valve delivery technology have catalyzed the feasibility of TF-TAVR, even in challenging anatomies. Report procedural characteristics and outcomes of a TAVR program aiming for a 100% TF access rate. Consecutive patients undergoing TAVR were enrolled in a prospective registry. Equipment used to facilitate TF-access in challenging anatomies included low-profile sheaths, dilatators, peripheral balloons, covered and uncovered self-expandingand balloon-expandable stents, and intravascular lithotripsy (IVL). A total of 400 patients with a mean age of 81 ± 6 years (42% female) were analyzed. Minimal iliofemoral artery diameter (MLD) of the main access side was <5 mm in 42 (10.5%), extreme tortuosity was present in 65 (16.3%), and severe calcification in 59 (14.8%). TF-access was successful in 399 (99.8%) patients. A transaxillary access was used in one patient. In multivariable analysis, an MLD < 5 mm was the strongest predictor for vascular complications (11.9% vs. 3.9%, OR: 3.86, 95% CI: 1.38-10.8, p = 0.01). Such patients also had more major/life-threatening bleeding (14.2% vs. 3.1%, p < 0.001) and required more planned and unplanned peripheral interventions to enable TFaccess (35.8% vs. 3.4%, p < 0.001). Our study shows that utilization of dedicated sheaths, peripheral balloons, stents, and IVL enables TAVR via TF access in >99% of patients. However, rates of vascular and bleeding complications in patients with narrow iliofemoral arteries (MLD < 5 mm) were high.

Short-Term Clinical Outcomes of Transcatheter Aortic Valve Replacement in a Developing Country.

Transcatheter aortic valve replacement (TAVR) is an effective alternative to surgical aortic valve replacement (SAVR) in patients with severe aortic stenosis in all surgical risk groups. Reports of clinical outcomes post-TAVR in developing countries are scarce. We aimed to address the clinical outcomes and safety profile of TAVR in a developing country. We conducted a single-center, retrospective study on patients undergoing TAVR at the American University of Beirut Medical Center (AUBMC) from January 2016 to April 2023. We included a total of 399 patients. Our primary endpoint was to assess the rate of TAVR in-hospital and 30-day mortality, neurologic events, and new permanent pacemaker implantation (PPI)in patients, stratified by the Society ofThoracic Surgeons (STS) risk of mortality score. Survival rates were 98.7% (394) at discharge vs. 97.5% (389) at 30 days post-procedure. The technical success rate was 95% (379) at the end of the procedure. Device success and early safety rates were 93.5% (373) and 83% (331), respectively at 30 days post-procedure. The all-cause mortality rate increased from 1.3% (5) at discharge to 2.5% (10) at 30-day intervals. The rate of ischemic stroke was 1.3% (five) at discharge and increased to 2% (eight) at 30 days post-procedure. PPI was needed in 5.8% (23) of patients at discharge with an increase to 7% (28) at one-month interval. Overall, the rates of TAVR outcomes among the three risk groups were comparable including neurologic events, valve-related complications, bleeding problems, vascular and access-related complications, and myocardial infarction. This study at AUBMC highlights the successful implementation of the TAVR program in a developing country, showcasing its efficacy and safety within 30 days post-operation, despite challenges such as financial constraints and limited access to specialized training. Larger cohorts and longer follow-up periods are needed to accurately represent clinical outcomes in developing countries.

Perceval-S over time. Clinical outcomes after ten years of usage

BackgroundPerceval-S has become a reliable and commonly used option in surgical aortic valve replacement (AVR) since its first implantation in humans 15 years ago. Despite the fact that this aortic valve has been proven efficient enough in the short and mid-term period, there is still lack of evidence for the long-term outcomes.Materials and methodsThis is an observational retrospective study in a high-volume cardiovascular center. Pertinent data were collected for all the patients in whom Perceval-S was implanted from 2013 to 2020.ResultsThe total number of patients was 205 with a mean age 76.4 years. Mean survival time was 5.5 years (SE = 0.26). The overall survival probability of patients undergoing aortic valve replacement with Perceval-S at 6 months was 91.0% (Standard Error SE = 2.0%), at one year 88.4% (SE = 2.3%) and at 5-years 64.8% (SE = 4.4%). A detrimental cardiac event leading to death was the probable cause of death in 35 patients (55.6%). The initiation of Transcatheter Aortic Valve Replacement (TAVR) program in our center in 2017 was associated with a decline in the number of very high-risk patients treated with sutureless bioprosthesis. This fact is demonstrated by the significant shift towards lower surgical risk cases, as median Euroscore II was reduced from 5,550 in 2016 to 3,390 in 2020. Mini sternotomy was implemented in 79,5% of cases favoring less invasive approach. Low incidence of reinterventions, patient prosthesis mismatch and structural valve degeneration was detected.ConclusionsThe survival rate after aortic valve replacement with implantation of Perceval-S is satisfactory in the long-term follow-up. Cases of bioprosthesis dysfunction were limited. Mini sternotomy was used in the majority of cases. TAVR initiation program impacted on the proportion of patients treated with Perceval-S with reduction of high-risk patients submitted to surgery.

Hospital procedural volume and clinical outcomes for transcatheter aortic valve replacement – US nationwide readmission database, 2016–2019

Abstract Background The number of hospitals offering transcatheter aortic valve replacement (TAVR) programs has increased exponentially in the United States over past several years. Multiple prior studies indicate relationship between hospital volume and clinical outcomes for various cardiac procedures. Purpose The association between the hospital procedural volume and clinical outcomes for TAVR is yet poorly understood. In this study, we aim to examine the in-hospital outcomes after TAVR stratified by hospital volume within a nationally representative, large database. Methods The National Readmission Database (NRD) 2016–2019 was used to identify hospitals with established TAVR programs (performing ≥20 TAVRs/year). Based on annualized procedural volume of transfemoral TAVR, hospitals were stratified into tertiles of low, medium, and high volume TAVR centers. Rates of adverse in-hospital events (death, cardiac arrest, stroke, vascular complications, and permanent pacemaker), 30-day mortality, and 30-day readmission rates were examined. Multivariate logistic regression analysis was performed to compare overall outcomes following TAVR in low-, medium-, and high-volume centers; adjusted for baseline characteristics and comorbidity burden. Results Of 71 million discharge records reviewed, a total of 232,581 patients underwent transfemoral TAVR between 2016–2019. Of all the TAVR cases, 77,183 (33.2%), 75,987 (32.7%), and 79,411 (34.1%) were performed at low-, medium-, and high-volume hospitals respectively. The median number of annual TAVR procedures was 91, 229, and 456 in low-, medium-, and high-volume centers respectively. Adjusted in-hospital mortality was significantly higher in low-volume (OR: 1.40, 95% CI: 1.21–1.62, p&amp;lt;0.01) and medium-volume (OR: 1.29, 95% CI: 1.11–1.50, p&amp;lt;0.01) hospitals compared with high-volume centers. Similarly, adjusted 30-day mortality (OR: 1.45, 95% CI: 1.27–1.66, p&amp;lt;0.01), 30-day readmission rates (OR: 1.11, 95% CI: 1.05–1.18, p&amp;lt;0.01), and in-hospital cardiac arrest (OR: 1.20, 95% CI: 1.08–1.33, p&amp;lt;0.01) were significantly higher for centers in the lowest-volume tertile compared with those in the highest-volume tertile. There were no significant differences in hospital length of stay (mean, 4.3±6.5 days), in-hospital stroke, acute kidney injury, vascular complications, need for permanent pacemaker, or mechanical circulatory support post-TAVR between the three groups. Conclusion In the United States, an inverse volume-mortality relationship was observed for transfemoral TAVR procedures from 2016 through 2019. Mortality and readmission rates at 30 days post-TAVR were significantly higher at low-volume hospitals compared with high-volume hospitals. Further research focusing at establishing protocols and standardized training programs may help mitigate the discrepancy in TAVR outcomes amongst hospitals with discrepant procedural volume. Funding Acknowledgement Type of funding sources: None.

Peri-procedural code status for transcatheter aortic valve replacement: Absence of program policies and standard practices.

Little is known about policies and practices for patients undergoing Transcatheter Aortic Valve Replacement (TAVR) who have a documented preference for Do Not Resuscitate (DNR) status at time of referral. We investigated how practices across TAVR programs align with goals of care for patients presenting with DNR status. Between June and September 2019, we conducted semi-structured interviews with TAVR coordinators from 52/73 invited programs (71%) in Washington and California (TAVR volume > 100/year:34%; 50-99:36%; 1-50:30%); 2 programs reported no TAVR in 2018. TAVR coordinators described peri-procedural code status policies and practices and how they accommodate patients' goals of care. We used data from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry, stratified by programs' DNR practice, to examine differences in program size, patient characteristics and risk status, and outcomes. Nearly all TAVR programs (48/50: 96%) addressed peri-procedural code status, yet only 26% had established policies. Temporarily rescinding DNR status until after TAVR was the norm (78%), yet time frames for reinstatement varied (38% <48 h post-TAVR; 44% 48 h-to-discharge; 18% >30 days post-discharge). For patients with fluctuating code status, no routine practices for discharge documentation were well-described. No clinically substantial differences by code status practice were noted in Society of Thoracic Surgeons Predicted Risk of Mortality risk score, peri-procedural or in-hospital cardiac arrest, or hospice disposition. Six programs maintaining DNR status recognized TAVR as a palliative procedure. Among programs categorically reversing patients' DNR status, the rationale for differing lengths of time to reinstatement reflect divergent views on accountability and reporting requirements. Marked heterogeneity exists in management of peri-procedural code status across TAVR programs, including timeframe for reestablishing DNR status post-procedure. These findings call for standardization of DNR decisions at specific care points (before/during/after TAVR) to ensure consistent alignment with patients' health-related goals and values.

Economic Considerations in Access to Transcatheter Aortic Valve Replacement

Transcatheter aortic valve replacement (TAVR) has revolutionized the treatment of aortic stenosis, with the number of procedures and sites offering the procedure steadily rising over the past decade in the United States. Despite this, growth into certain markets has been limited as hospitals have to balance high TAVR costs with the ability to offer a complete array of state-of-the-art therapies for aortic stenosis. This trade-off often results in decreased access to TAVR services by patients cared for in hospitals that cannot afford these services or have difficulty meeting procedural requirements, recruiting skilled physicians, and initiating and then maintaining a functioning TAVR program. The lack of access is more common among patients of color or those who are socioeconomically disadvantaged. The purpose of this review is to describe the hospital-level economic considerations of TAVR in the United States and the resulting effects on geographic, racial, ethnic, and socioeconomic access for Americans.

Carotid Duplex Poorly Predicts Stroke Risk During Transcatheter Aortic Valve Replacement

Patients undergoing surgical aortic valve replacement, in isolation or with concomitant coronary artery bypass grafting, have historically been screened for carotid artery disease prior to surgery. Over the past decade, transcatheter aortic valve replacement (TAVR) has incrementally become the predominant technique for the treatment of severe aortic stenosis. The relationship between internal carotid artery stenosis (ICAS) and risk of periprocedural stroke in the TAVR population is uncertain. We sought to evaluate our institution's outcomes with the TAVR procedure and the association with preoperative carotid duplex scan (CDS) results. A retrospective review of a single institution TAVR registry over a 5-year period was performed. All patients with pre-operative carotid imaging were included. Outcomes included in-hospital, 30-day, and 1-year stroke and all-cause mortality rates. The diagnosis of post-operative stroke was based on neurological exam and confirmed by radiologic imaging. Standard statistical analysis was performed. A total of 436 patients met inclusion criteria. The prevalence of ICAS >50% was 18.3% and 70-99% stenosis was 4.8%. The in-hospital stroke and mortality rates were 2.3% and 1.2%, respectively. The cumulative 30-day and 1- year stroke rates were 3.7% and 6%, respectively. All were ischemic in nature. Bilateral infarcts were identified in 46.2% of stroke patients and 11.5% had an ipsilateral ICAS >50%. A large majority of stroke patients (23, 88.5%) had an ipsilateral ICAS of <50%. Less than 0.5% of patients had ICAS >70% and subsequently had an ipsilateral stroke within 30 days of procedure. The preoperative CDS identified carotid lesions that met criteria for elective repair in only 4.8% of patients. Of these, 9.5% suffered a stroke in the first 30 days after surgery. Over 90% of patients who had a stroke had less than 70% stenosis present in either carotid artery and there was no correlation between degree of ICAS and risk of stroke during the follow-up period. Routine CDS prior to TAVR does not predict in-hospital or 30-day stroke. As TAVR programs evolve, expand, and proliferate across the country, routine preoperative CDS is unlikely to determine the need for pre-operative carotid revascularization or predict stroke risk.

Racial, Ethnic, and Socioeconomic Disparities in Access to Transcatheter Aortic Valve Replacement Within Major Metropolitan Areas

Despite the benefits of high-technology therapeutics, inequitable access to these technologies may generate disparities in care. To examine the association between zip code-level racial, ethnic, and socioeconomic composition and rates of transcatheter aortic valve replacement (TAVR) among Medicare patients living within large metropolitan areas with TAVR programs. This multicenter, nationwide cross-sectional analysis of Medicare claims data between January 1, 2012, and December 31, 2018, included beneficiaries of fee-for-service Medicare who were 66 years or older living in the 25 largest metropolitan core-based statistical areas. Receipt of TAVR. The association between zip code-level racial, ethnic, and socioeconomic composition and rates of TAVR per 100 000 Medicare beneficiaries. Within the studied metropolitan areas, there were 7590 individual zip codes. The mean (SD) age of Medicare beneficiaries within these areas was 71.4 (2.0) years, a mean (SD) of 47.6% (5.8%) of beneficiaries were men, and a mean (SD) of 4.0% (7.0%) were Asian, 11.1% (18.9%) were Black, 8.0% (12.9%) were Hispanic, and 73.8% (24.9%) were White. The mean number of TAVRs per 100 000 Medicare beneficiaries by zip code was 249 (IQR, 0-429). For each $1000 decrease in median household income, the number of TAVR procedures performed per 100 000 Medicare beneficiaries was 0.2% (95% CI, 0.1%-0.4%) lower (P = .002). For each 1% increase in the proportion of patients who were dually eligible for Medicaid services, the number of TAVR procedures performed per 100 000 Medicare beneficiaries was 2.1% (95% CI, 1.3%-2.9%) lower (P < .001). For each 1-unit increase in the Distressed Communities Index score, the number of TAVR procedures performed per 100 000 Medicare beneficiaries was 0.4% (95% CI, 0.2%-0.5%) lower (P < .001). Rates of TAVR were lower in zip codes with higher proportions of patients of Black race and Hispanic ethnicity, despite adjusting for socioeconomic markers, age, and clinical comorbidities. Within major metropolitan areas in the US with TAVR programs, zip codes with higher proportions of Black and Hispanic patients and those with greater socioeconomic disadvantages had lower rates of TAVR, adjusting for age and clinical comorbidities. Whether this reflects a different burden of symptomatic aortic stenosis by race and socioeconomic status or disparities in use of TAVR requires further study.

Same Day Discharge during the COVID-19 Pandemic in Highly Selected Transcatheter Aortic Valve Replacement Patients

ABSTRACT Background Transcatheter aortic valve replacement (TAVR) with a standardized clinical pathway allows most patients to achieve safe next-day discharge. This approach has been successfully implemented across global centers as part of the Benchmark Program. Considering restricted hospital resources resulting from the COVID-19 pandemic, a modified same day discharge (SDD) clinical pathway was implemented for selected TAVR patients at a single Benchmark site. Methods All patients accepted for TAVR were assessed for the SDD clinical pathway. Eligibility criteria included adequate social support and accessibility to the TAVR program post-discharge. Patients with preexisting conduction disease were excluded. The clinical pathway comprised of mobilization, bloodwork and electrocardiogram 4 hours post-TAVR and discharge ≥8 hours following groin hemostasis. Results From June to December 2020, 142 patients underwent TAVR at a single community Benchmark site. Of those, 29 highly selected patients were successfully discharged the same day using the SDD clinical pathway. There were no vascular access complications, permanent pacemaker (PPM) implantation, or mortality in the SDD group during index admission or at 30-day follow-up. When compared to a standard therapy group, there was no statistically significant difference in 30-day cardiovascular readmission. Conclusions This study demonstrates the safety and feasibility of same day discharge post-TAVR in a highly selected cohort of patients, with no observable difference in safety outcomes when compared to patients who were discharged according to standard institutional practice.Abbreviations: AS: aortic stenosis; ACT: Activated clotting time; AV: atrioventricular; AVB: atrioventricular block; BBB: bundle branch block; CAIC: Canadian Society for Cardiovascular Angiography; CCL: cardiac catheterization laboratory; CT: Computed topography; CV: cardiovascular; IQR: Interquartile Range; IVCD: intraventricular conduction delay; LBBB: left bundle branch block; LOS: length of stay; NDD: next day discharge; PPM: permanent pacemaker; RBBB: right bundle branch block; SCAI: Society for Cardiovascular Angiography and Intervention; SD: standard deviation; SDD: same day discharge; ST: standard therapy; STS PROM: society of thoracic surgeons predicted risk of mortality; TAVR: transcatheter aortic valve replacement; TF: transfemoral; THV: transcatheter heart valve; TTE: transthoracic echocardiogram; VARC: Valve Academic Research Consortium

The Impact of a TAVR Program on a Vascular Surgery Practice

<h3>Background</h3> Transcatheter aortic valve replacement (TAVR) is a less invasive alternative to surgical aortic valve repair offering treatment to candidates who may not tolerate a more robust surgical intervention. Five years ago, the cardiology group in our rural community initiated a TAVR program to further address the need for cardiac care. Operating under the heart team model our vascular surgery group has worked alongside interventional cardiologists and cardio-thoracic surgeons to ensure safe interventions. To date, over 300 patients within this community have undergone this procedure. <h3>Objective</h3> The purpose is to observe the role of the vascular surgeon in management of patients undergoing TAVR in a rural hospital setting. <h3>Methods</h3> Clinical data from a multi-specialty practice database was used for this study of 292 TAVR patients from 2016 through 2021. Patients were treated in a multidisciplinary approach with involvement of vascular surgeons, interventional cardiologists and cardio-thoracic surgeons. <h3>Results</h3> Of the 292 TAVR patients 275 (94.2%) were over the age of 65. Multiple patients required alternative access other than the standard transfemoral approach including 8 axillary, 2 trans-aortic, 1 each trans-apical and trans-septal. Vascular surgeons have been invaluable in management of intra-procedure and post-procedure complications. A dislodged aortic valve was deployed in the thoracic aorta and covered with aortic stent graft. For calcified access, vascular surgery has provided shock wave lithotripsy treatment to aid large sheath introduction. Other complications encountered include aortic dissection, acute limb ischemia, distal embolization and major access related hemorrhage. <h3>Conclusions</h3> Vascular surgery will continue to be an important partner in the care of TAVR patients in this medium sized rural health care setting. Vascular surgical assistance has aided in stabilization of concurrent disease, management of intraoperative complications and emergencies, and obtaining complex vascular access.

Socioeconomic and Geographic Characteristics of Hospitals Establishing Transcatheter Aortic Valve Replacement Programs, 2012-2018.

Despite the benefits of novel therapeutics, inequitable diffusion of new technologies may generate disparities. We examined the growth of transcatheter aortic valve replacement (TAVR) in the United States to understand the characteristics of hospitals that developed TAVR programs and the socioeconomic status of patients these hospitals served. We identified fee-for-service Medicare beneficiaries aged 66 years or older who underwent TAVR between January 1, 2012, and December 31, 2018, and hospitals that developed TAVR programs (defined as performing ≥10 TAVRs over the study period). We used linear regression models to compare socioeconomic characteristics of patients treated at hospitals that did and did not establish TAVR programs and described the association between core-based statistical area level markers of socioeconomic status and TAVR rates. Between 2012 and 2018, 583 hospitals developed new TAVR programs, including 572 (98.1%) in metropolitan areas, and 293 (50.3%) in metropolitan areas with preexisting TAVR programs. Compared with hospitals that did not start TAVR programs, hospitals that did start TAVR programs treated fewer patients with dual eligibility for Medicaid (difference of -2.83% [95% CI, -3.78% to -1.89%], P≤0.01), higher median household incomes (difference $2447 [95% CI, $1348-$3547], P=0.03), and from areas with lower distressed communities index scores (difference -4.02 units [95% CI, -5.43 to -2.61], P≤0.01). After adjusting for the age, clinical comorbidities, race and ethnicity and socioeconomic status, areas with TAVR programs had higher rates of TAVR and TAVR rates per 100 000 Medicare beneficiaries were higher in core-based statistical areas with fewer dual eligible patients, higher median income, and lower distressed communities index scores. During the initial growth phase of TAVR programs in the United States, hospitals serving wealthier patients were more likely to start programs. This pattern of growth has led to inequities in the dispersion of TAVR, with lower rates in poorer communities.

Temporal Trends and Drivers of Heart Team Utilization in Transcatheter Aortic Valve Replacement: A Population-Based Study in Ontario, Canada.

BackgroundThe multidisciplinary Heart Team (HT) is recommended for management decisions for transcatheter aortic valve replacement (TAVR) candidates, and during TAVR procedures. Empiric evidence to support these recommendations is limited. We aimed to explore temporal trends, drivers, and outcomes associated with HT utilization.Methods and ResultsTAVR candidates were identified in Ontario, Canada, from April 1, 2012 to March 31, 2019. The HT was defined as having a billing code for both a cardiologist and cardiac surgeon during the referral period. The procedural team was defined as a billing code during the TAVR procedure. Hierarchical logistical models were used to determine the drivers of HT. Median odds ratios were calculated to quantify the degree of variation among hospitals. Of 10 412 patients referred for TAVR consideration, 5489 (52.7%) patients underwent a HT during the referral period, with substantial range between hospitals (median odds ratio of 1.78). Utilization of a HT for TAVR referrals declined from 69.9% to 41.1% over the years of the study. Patient characteristics such as older age, frailty and dementia, and hospital characteristics including TAVR program size, were found associated with lower HT utilization. In TAVR procedures, the procedural team included both cardiologists and cardiac surgeons in 94.9% of cases, with minimal variation over time or between hospitals.ConclusionsThere has been substantial decline in HT utilization for TAVR candidates over time. In addition, maturity of TAVR programs was associated with lower HT utilization.

Transcatheter Aortic Valve Replacement in Lebanon: Population and Procedural Characteristics and Long-term Outcome – A Single Center Experience

Background: Transcatheter aortic valve replacement (TAVR) programs are growing in the Middle East, but data on treated patients in this region is scarce. We sought in this study to analyze the largest single-center population in Lebanon. Methods and Results: Baseline clinical, procedural characteristics as well as in-hospital and up to five years follow-up outcomes were collected and analyzed for the 141 patients (80 ± 7 years, 51.8% females) included between 2014 and 2019. All-cause mortality at 30 days found in 5 (3.5%) cases was considered as the primary endpoint while Major Adverse Cardiovascular Events at 30 days as secondary ones: cardiovascular mortality in 3 cases (2.1%), strokes in 1 case (0.7%), percutaneous coronary intervention in 3 cases (2.1%) and myocardial infarction in 3 cases (2.1%). Device success and intended prosthesis performance were achieved in 119 (84.4%) and 121 (85.8%) patients, respectively. Multivariate analysis showed that cardiovascular mortality is strongly associated with end-stage renal failure and peripheral artery disease. The dichotomization of patients into two cohorts A and B corresponding to the first and second 3 years of the TAVR time interval showed slow evolution of TAVR patients to a younger and lower risk population but maintained good results. Conclusion: TAVR in Lebanon shows satisfactory results and good long-term outcomes. Data from the regional prospective registry is needed to assess the evolution of this therapy in the middle-east region.

Surgical Aortic Valve Replacement Outcomes in Non–Transcatheter Aortic Valve Replacement Centers: Implications for Tier-Based Systems of Care

BackgroundWith wide expansion of transcatheter aortic valve replacement (TAVR) and dissemination of multidisciplinary-based approaches to care, societies are discussing the implementation of a tier system to valve centers. This study explores the impact of tier-based systems of care on surgical aortic valve replacement (SAVR) outcomes at institutions that perform SAVR only. MethodsMedicare beneficiaries undergoing SAVR procedures from 2012 to 2015 were included. The SAVR hospitals were stratified into either tier A, valve centers with a TAVR program; or tier B, valve centers without a TAVR program. Adjusted survival, assessed by multivariable Cox regression, controlled for program type and patient risk profile. Time-dependent analysis accounted for hospitals that initiated a TAVR program during the study period. ResultsOverall, there were 562 tier A and 485 tier B SAVR hospitals. Tier A hospitals had significantly higher comorbidity burden compared with tier B hospitals (all P < .05) but had significantly lower rates of 30-day mortality (3.2% vs 4.1%) and 1-year mortality (8.1% vs 9.4%; both P < .05). After risk stratification, tier B hospitals had significantly worse 30-day mortality compared with tier A hospitals for all patient risk-profiles, except for the low-risk patients (P < .01). These findings persisted in the time-dependent analysis. Adjusted midterm survival was higher in tier A vs tier B hospitals. ConclusionsLow-risk patients can safely undergo SAVR in both tier level hospitals without compromising outcomes. Establishment of quality of care measures, especially in the SAVR-only hospitals, remains paramount and should be closely integrated when designing tier-based systems for aortic valve replacement care.

Transcatheter aortic valve replacement: An alternative for severe aortic stenosis.

Transcatheter aortic valve replacement (TAVR) is considered a lower-risk procedure for patients with severe aortic valve stenosis. Several FDA-approved trials performed in the United States support TAVR to be beneficial over surgical aortic valve replacement in certain patient populations. An optimal TAVR program consists of a multidisciplinary team that selects candidates for the procedure based on shared decision-making and the patient's anatomy and risk factors, and follows the patients through the Transcatheter Valve Therapy National Registry.

Prognostic Impact of Change in Nutritional Risk on Mortality and Heart Failure After Transcatheter Aortic Valve Replacement

Limited data are available regarding change in the nutritional status after transcatheter aortic valve replacement (TAVR). This study evaluated the prognostic impact of the change in the geriatric nutritional risk index following TAVR. TAVR patients were analyzed in a prospective and observational study. To analyze the change in nutritional status, geriatric nutritional risk index of the patients was calculated on the day of TAVR and at 3-month follow-up. The impact of the change in nutritional risk index after TAVR on all-cause mortality, heart failure hospitalization (HF-h), and the composite of all-cause death and HF hospitalization was analyzed using the Cox Proportional Hazards model. Four hundred thirty-three patients were included. After TAVR, 68.4% (n=182) patients with baseline nutritional risk improved compared with 31.6% (n=84) who remained at nutritional risk. The change from no-nutritional risk to nutritional risk after TAVR occurred in 15.0% (n=25), while 85.0% (n=142) remained without risk of malnutrition. During follow-up, 157 (36.3%) patients died and 172 patients (39.7%) were hospitalized due to HF. Patients who continued to be at nutritional risk had a higher risk of mortality (hazard ratio [HR], 2.10 [95% CI, 1.30-3.39], P=0.002), HF-h (HR, 1.97 [95% CI, 1.26-3.06], P=0.000), and the composite of death and HF-h (HR, 2.0 [95% CI, 1.37-2.91], P<0.001). The change to non-nutritional risk after TAVR significantly impacted mortality (HR, 0.48 [95% CI, 0.30-0.78], P=0.003), HF-h (HR, 0.50 [95% CI, 0.34-0.74], P=0.001), and the composite outcome (HR, 0.44 [95% CI, 0.32-0.62], P<0.001). Remaining at nutritional risk after TAVR confers a poor prognosis and is associated with an increased risk of mortality and HF-h, while the change from risk of malnutrition to non-nutritional risk after TAVR was associated with a halving of the risk of mortality and HF-h. Further studies are needed to identify whether patients at nutritional risk would benefit from nutritional intervention during processes of care of TAVR programs.

Transcarotid Transcatheter Aortic Valve Replacement

The number of transcatheter aortic valve replacement (TAVR) procedures have increased dramatically over the last decade; so too have the number of TAVR centers. While a percutaneous femoral artery approach is the access of choice, many patients have peripheral artery disease that prohibits access despite newer smaller diameter TAVR delivery systems. It is imperative for TAVR programs to have a preferred alternative access technique. The transcarotid approach is advantageous because the surgical skills and endovascular techniques required should be familiar to most surgeons, and when not, are, in our experience, readily obtainable. Here we provide a detailed description of the technical aspects of our approach to transcarotid TAVR.

Prognostic value of change in nutritional status after transcatheter aortic valve replacement

Abstract Introduction and purpose Risk of malnutrition is a frequent condition among patients undergoing transcatheter aortic valve replacement (TAVR). Nutritional status assessed by nutritional risk index (NRI) is independently associated with an increased risk of death during long-term follow-up in these patients. The aim of the study is to determine the prognostic impact of the variation in nutritional risk after TAVR. Methods TAVR patients were included in an observational and prospective study between 2008–2019. Baseline and 3-months post-TAVR NRI were calculated as 1.519 x albumin (g/L) + 41.7 x (real weight [kg]/ideal weight [kg]). According to this parameter, the risk of malnutrition was severe (NRI&amp;lt;83.5), moderate (83.5≥NRI&amp;lt;97.5) and mild (97.5≥NRI&amp;lt;100). We analyzed the change in nutritional status after TAVR and the association between nutritional status variation and the clinical outcomes: all-cause mortality, heart failure hospitalization and the composite of all-cause death and/or heart failure hospitalization at 3 years follow-up using the Cox proportional hazards model. Results 433 patients were included. 68.4% of patients with baseline nutritional risk had no nutritional risk after TAVR. The prevalence of risk of malnutrition was reduced to 25.2% after TAVR. During the follow-up (2.7±2.0 years), 157 (36.3%) patients died and 172 patients (39.7%) had heart failure hospitalization. Patients who remained at nutritional risk after TAVR had a higher risk of mortality (HR: 2.10 [95% CI: 1.30 to 3.39], p=0.002), heart failure hospitalization (HR: 1.97 [95% CI: 1.26 to 3.06], p=0.000) and the composite outcome (HR: 2.0 [95% CI: 1.37 to 2.91], p&amp;lt;0.001). Conclusions Risk of malnutrition was a frequent condition among TAVR patients, but most patients improved their nutritional status after the procedure. The change in nutritional status is associated with prognosis: post-TAVR nutritional risk improvement is associated with reduced heart failure hospitalization, and the change to non-nutritional risk after TAVR halved the risk of mortality and heart failure hospitalization during long-term follow-up. Persistent nutritional risk after TAVR was related to poor prognosis. Further studies are needed to identify whether at nutritional risk would benefit from nutritional intervention during processes of care of TAVR programs. Change in NRI and prognostic value Funding Acknowledgement Type of funding source: None

Transcatheter aortic valve replacement during the COVID-19 pandemic-A Dutch single-center analysis.

Background and Aim of the StudyThe coronavirus disease 2019 (COVID‐19) pandemic has put an enormous strain on healthcare systems and intensive care unit (ICU) capacity, leading to suspension of most elective procedures, including transcatheter aortic valve replacement (TAVR). However, deferment of TAVR is associated with significant wait‐time mortality in patients with severe aortic valve stenosis. Conversely, there is currently no data available regarding the safety and feasibility of a continued TAVR program during this unprecedented crisis. The aim of this study is to evaluate the safety and feasibility of patients undergoing TAVR during the COVID‐19 pandemic in our center, with specific emphasis on COVID‐19 related outcomes.MethodsAll patients who underwent TAVR in our center between February 27, 2020, and June 30, 2020, were evaluated. Clinical outcomes were described in terms of Valve Academic Research Consortium 2 definitions. Patient follow‐up was done by chart review and telephone survey.ResultsA total of 71 patients have undergone TAVR during the study period. Median age was 80 years, 63% were men, and 25% were inpatients. Procedural success was 99%. After TAVR, 30% involved admission to the ICU, and 94% were ultimately discharged to the cardiac care unit on the same day. Two patients (3%) had confirmed COVID‐19 a few days after TAVR, and both died of COVID‐19 pneumonia within 2 weeks after hospital discharge.ConclusionsA continued TAVR program during the COVID‐19 pandemic is feasible despite limited hospital resources. However, COVID‐19 related mortality after TAVR is of concern.

Feasibility and safety of a fully percutaneous transcatheter aortic valve replacement program.

This study aimed to assess the feasibility and safety of conducting an entire transcatheter aortic valve replacement (TAVR) program by using percutaneous techniques only. Surgically assisted transthoracic TAVR has been reported to be associated with more complications and longer hospital stays. During 2019, all TAVR at a single center were performed by standard transfemoral (TF), intravascular lithotripsy-assisted TF, transaxillary (TAx), or transcaval approach using percutaneous techniques only. No patients were denied TAVR because of access. Procedural and clinical endpoints were categorized using Valve Academic Research Consortium-2 criteria. In total, 306 consecutive TAVR patients were enrolled (mean age 78.9 ± 7.2 years). Most patients were treated by TF approach (94.8%)-of these, nine (2.9%) were pre-treated with intravascular lithotripsy. A percutaneous TAx and transcaval approach were used in 12 (3.9%) and four patients (1.3%), respectively. There were no procedural deaths and one peri-procedural stroke. Valve performance was satisfying in 298 patients (97.4%); six patients had a moderate aortic regurgitation and two patients had a mean gradient ≥20 mmHg following valve-in-valve procedure. The 30-day major vascular complication and major bleeding rate was 2.3% and 3.9%, respectively. A new permanent pacemaker was implanted in 41 patients (13.4%). Of all patients, 81% were discharged within two days post-TAVR, including 11 out of 12 TAx patients and all transcaval cases. A fully percutaneous TAVR program is feasible and safe with favorable immediate and early clinical outcomes and allowing a short hospital stay.