Circulation: Cardiovascular Interventions: The First 10 Years.

Multisociety (AATS, ACCF, SCAI, and STS) Expert Consensus Statement: Operator and Institutional Requirements for Transcatheter Valve Repair and Replacement, Part 1: Transcatheter Aortic Valve Replacement

Hypertrophy is considered one of the major mechanisms of the myocardium for adapting to hemodynamic overload. More muscle mass provides more contractile elements for generating the extra work required by the overload. In pressure overload of aortic valve stenosis, concentric left ventricular hypertrophy (LVH) normalizes wall stress, a key determinant of ejection performance.1 Afterload is often expressed as wall stress (pressure×radius/thickness). As the pressure term in the numerator increases, it is offset by an increase in the thickness term of the denominator. In this way, the high systolic pressure required to drive blood through even a very stenotic aortic valve can be consistent with normal afterload and normal ejection fraction. See p 3170 Unfortunately, hypertrophy not only provides benefits but also has many pathological consequences. One of these is myocardial ischemia and the attendant angina reported by patients with aortic stenosis despite normal epicardial coronary arteries. The onset of angina greatly increases the risk of sudden death compared with the risk in asymptomatic patients with aortic valve stenosis.2,3 Angina occurs when myocardial oxygen demand exceeds supply. Demand is proportional to heart rate and wall stress, and the latter can be elevated in cases of aortic stenosis when hypertrophy is inadequate to normalize stress.1 After aortic valve replacement, there is marked regression of hypertrophy that may occur over the next several months to years,4 but angina is relieved immediately. Relief of angina immediately after surgery is probably due to the combination of sudden decreased oxygen demand after removal of pressure overload and increased oxygen supply of improved perfusion. However, there are remaining questions about the physiological mechanisms for reduced myocardial oxygen supply (coronary blood flow) in aortic stenosis and its improvement after relief of pressure overload. Specifically, what is it about critical aortic stenosis that is “critical” …

Robotic aortic valve replacement

2019 AATS/ACC/ASE/SCAI/STS expert consensus systems of care document: A proposal to optimize care for patients with valvular heart disease: A joint report of the American Association for Thoracic Surgery, American College of Cardiology, American Society of Echocardiography, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons

The evidence of the benefits of transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) for patients of high or intermediate surgical risk is not consistent. We performed a meta-analysis to compare major adverse outcomes after TAVR or SAVR. We searched propensity score matched studies or randomized clinical trials comparing the risks of mortality, stroke, major bleeding, acute renal injury, pacemaker implantation, vascular complications and prostheses haemodynamic performance between TAVR and SAVR in patients with moderate or high risk. Combined odds ratios (ORs), relative risk or mean differences with corresponding 95% confidence intervals (CIs) were calculated using a random effects model. Analyses of sensitivity and publication bias were also conducted. We included 5 clinical trials and 37 observational studies, enrolling 20224 patients (TAVR, n = 9099 and SAVR, n = 11125). The pooled analysis suggested no differences in early (OR = 1.11, 95% CI 0.9-1.39, P = 0.355) or late mortality (relative risk = 0.91, 95% CI 0.78-1.05, P = 0.194). TAVR was associated with a lower risk of major bleeding (OR = 0.42, 95% CI 0.25-0.69, P < 0.001) and acute kidney injury (OR = 0.51, 95% CI 0.34-0.71) but with an increase in the incidence of pacemaker implantation (OR = 2.31, 95% CI 1.73-3.08) and vascular complications (OR = 4.88, 95% CI 2.84-8.39). Residual aortic regurgitation was more frequent after TAVR (OR= 6.83, 95% CI 4.87-9.6). SAVR prostheses were associated with poor trans-prosthetic gradients (mean difference: -2.4 mmHg, 95% CI - 3.27 to - 1.53). TAVR and SAVR have similar short and long-term all-cause mortality and risk of stroke among patients of moderate or high surgical risk. TAVR decreases the risk of major bleeding, acute kidney injury and improves haemodynamic performance compared with SAVR but increases the risk of vascular complications, the need for a pacemaker and residual aortic regurgitation.

Outcomes Following Shock Aortic Valve Replacement: Transcatheter Versus Surgical Approaches

Surgical aortic valve replacement (SAVR) is the commonly used approach for aortic valve replacement (AVR) in patients with aortic stenosis at low or intermediate surgical risk. However, transcatheter aortic valve replacement (TAVR) has emerged as an alternative to SAVR for AVR. This meta-analysis aims to assess the comparative efficacy and safety of TAVR versus SAVR in low-to-intermediate surgical risk patients by analyzing temporal trends in the outcomes of TAVR and SAVR at various follow-up intervals, providing a more detailed understanding. A thorough literature search was performed across PubMed/MEDLINE, Embase, and the Cochrane Library from their inception up to May 2024 to identify eligible randomized controlled trials (RCTs). Clinical outcomes were evaluated using a random-effects model to pool risk ratios (RRs) with 95% CIs. A total of 17 studies reporting data at different follow-ups for nine trials were included (n=9092). No statistically significant difference was observed between TAVR and SAVR for reducing all-cause death at 30 days, 1 year, and 2 years but significantly increased risk with TAVR at 5 years or longer follow-up (RR=1.13, 95% CI: 1.03-1.23). However, TAVR was associated with a significantly decreased risk for cardiac death at 1-year follow-up (RR=0.79, 95% CI: 0.64-0.96) and comparable risk for cardiac death at 30 days, 2 years, and 5 years or longer follow-up when compared with SAVR. No statistically significant difference was observed between TAVR and SAVR for reducing the risk of myocardial infarction (MI) at 30 days, 1 year, 2 years, and 5 years or longer follow-up.TAVR was associated with a significantly lower risk of major bleeding events at 30 days (RR=0.38, 95% CI: 0.21-0.67); lower risk of acute kidney injury (AKI) at 30 days (RR=0.38, 95% CI: 0.26-0.54) and 1 year (RR=0.58, 95% CI: 0.41-0.82) and lower risk of new onset or worsening atrial fibrillation (AF) at 30 days (RR=0.25, 95% CI: 0.18-0.34), 1 year (RR=0.26, 95% CI: 0.16-0.41) and 2 years (RR=0.32, 95% CI: 0.20-0.49) when compared with SAVR. However, TAVR was associated with a significantly increased risk of permanent pacemaker implantation (PPI) at 30 days (RR: 2.62, 95% CI: 1.40-4.91), at 1 year (RR: 2.19, 95% CI: 1.24-3.87), at 2 years (RR: 2.74, 95% CI: 1.31-5.71), and beyond 5 years (RR: 1.95, 95% CI: 1.20-3.15). TAVR was also associated with a significantly increased risk of prosthetic valve thrombosis at 2 years (RR=2.70, 95% CI: 1.08-6.71), though no significant association was observed at 30 days, 1 year, or 5 years. Similarly, no significant differences were observed in aortic-valve reintervention rates at 30 days, 2 years, or 5 years, but TAVR showed a significantly increased risk at 1 year (RR=1.98, 95% CI: 1.21-3.24). TAVR was associated with a significantly increased risk of major vascular complications at 30 days (RR=2.37, 95% CI: 1.38-4.04) and a significantly increased risk of TIA at 2 years (RR: 1.43, 95% CI: 1.02-2.00, I2=0%). The risk of hospitalizations was comparable between the groups. TAVR and SAVR demonstrated comparable rates of all-cause death up to 2 years of follow-up. However, at 5 years or longer follow-up, TAVR was associated with a higher risk of all-cause death. While TAVR showed certain procedural advantages, such as a lower risk of major bleeding, AKI, and new-onset or worsening AF, the choice between TAVR and SAVR in patients with low or intermediate surgical risk should consider long-term outcomes, with SAVR potentially being more favorable due to better survival observed on longer follow-up durations.

Initial trials comparing stenting with balloon angioplasty demonstrated improved angiographic and clinical outcomes with the former.1–3 The main clinical problem with bare metal stents (BMS) became the development of in-stent restenosis.4–6 Early data suggested that drug-eluting stents (DES) could mitigate, if not abolish, this problem.7–9 Since the approval of DES, these devices have become the predominant stents used in percutaneous coronary interventions, regardless of indication. As of September 2007, the Cypher sirolimus-eluting stent (SES) (Cordis Johnson & Johnson, Miami Lakes, Fla) had been deployed in >3 million patients worldwide,10 and the millionth Taxus paclitaxel-eluting stent (PES) (Boston Scientific, Natick, Mass) was implanted as of January 2005.11 Over the past 2 years, numerous reports of very late stent thrombosis (ST) with first-generation DES have surfaced. This highly morbid complication and data suggesting that death and myocardial infarction (MI) may be more common with DES12,13 have altered the focus of trials and registries working to determine optimal DES use. There is a hope that second-generation DES will be less prone to ST as a result of differences in drug, stent design, and polymer. Medtronic, Inc (Minneapolis, Minn) presented safety and efficacy data to a public meeting of the US Food and Drug Administration (FDA) Circulatory System Devices Panel (CSDP) in October 2007 on its Endeavor zotarolimus-eluting stent (ZES), seeking approval for the indication of treating de novo native coronary lesions ≤27 mm with reference vessel diameters of 2.5 to 3.5 mm. The FDA asked the CSDP to determine whether the data presented demonstrated a reasonable level of safety and effectiveness, with clinical benefits clearly outweighing short- and long-term risks of ZES use. Important efficacy end points included ischemia-driven target lesion revascularization (TLR) or target vessel revascularization (TVR); safety end points included death, MI, and ST. The …

To assess the in-hospital mortality and complications in female between transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR). Female is one of the risk factors for increased adverse events in cardiac surgery. Nationwide Inpatient Sample database was queried from 2011 to 2014 for patients who underwent TAVR or SAVR in female patients. The primary endpoint was in-hospital all-cause mortality and second endpoints were perioperative complications. We performed a propensity score analysis to calculate the adjusted odds ratio (OR) for each outcome. Patients who had concomitant cardiac surgery and those who had TAVR or SAVR mainly for aortic regurgitation were excluded. Our query from 2011 to 2014 resulted in a total of 3,067 TAVR and 18,594 SAVR in female patients. TAVR patients were in general elder and had a higher burden of comorbidities. The primary endpoint was similar between TAVR and SAVR (4.2% vs. 3.9%, OR 1.0, P = 0.89). Compared to SAVR, female TAVR patients had less hemorrhage requiring transfusion (12% vs. 21%, OR 0.41, P < 0.001), perioperative cardiac arrest and nonfatal myocardial infarction (9.8% vs. 17%, OR 0.38, P < 0.001), respiratory complication (1.6% vs. 4.4%, OR 0.28, P < 0.001), post-op sepsis (1.7% vs. 2.9%, OR 0.65, P = 0.03), acute myocardial infarction (3.0% vs. 4.9%, OR 0.60, P < 0.001), and acute kidney injury (15% vs. 18%, OR 0.62, P < 0.001). Conversely, female TAVR patients had significantly increased risk of new pacemaker implantation (11% vs. 5.9%, OR 1.7, P < 0.001) and use of extracorporeal membrane oxygenation (0.66% vs. 0.24%, OR 2.8, P < 0.001). TAVR patients had less nonroutine discharge. The median hospital cost was significantly higher in TAVR than SAVR (median $51,274 vs. $43,677, P < 0.001) but the length of stay was shorter (mean 7.8 days vs. 10.5 days). TAVR may be a better option for those patients with underlying comorbidities that predispose them at higher risk for complications that was less observed in TAVR group. However, higher cost and increased risk of need for extracorporeal membrane oxygenation, although rare, should be taken into consideration upon deciding the optimal mode for aortic valve replacement.

Transcatheter and Surgical Aortic Valve Replacement Outcomes for Patients with Chronic Heart Failure

Background Referral rates and outcomes of cardiac rehabilitation have not been evaluated in patients with transcatheter aortic valve replacement or compared with surgical aortic valve replacement. Method A retrospective cohort study was conducted in 488 patients who underwent transcatheter aortic valve replacement ( n = 199) and surgical aortic valve replacement ( n = 289) from a university-based statewide transcatheter aortic valve replacement/surgical aortic valve replacement program during 2015-2017. Cardiac rehabilitation consisted of supervised exercise, diet education, and stress and depression management. We compared changes from baseline in exercise duration and intensity during cardiac rehabilitation sessions, quality-of-life (36-Item Short-Form Health Survey), and psychosocial measures (anxiety, depression, mood, social support, and diet) between transcatheter aortic valve replacement and surgical aortic valve replacement patients using t-test and chi-square analyses. Results Of 488 patients, cardiac rehabilitation referral rates were similar at 41% (transcatheter aortic valve replacement 81/199 versus surgical aortic valve replacement 117/289), but enrollment rates were lower in transcatheter aortic valve replacement (27/199, 14%) versus surgical aortic valve replacement (102/289, 35%, p < 0.01). Among eligible patients, cardiac rehabilitation completion rates were lower in transcatheter aortic valve replacement (12%) than surgical aortic valve replacement (32%). Exercise intensity during cardiac rehabilitation improved in both groups in a similar fashion (transcatheter aortic valve replacement 1.03 ± 1.09 versus surgical aortic valve replacement 1.34 ± 1.15 metabolic equivalents), but increase in exercise duration was higher in transcatheter aortic valve replacement patients versus surgical aortic valve replacement patients (14.52 ± 6.42 versus 10.67 ± 8.38 min, p = 0.02). Improvement in physical composite score was higher in surgical aortic valve replacement versus transcatheter aortic valve replacement (8.72 ± 7.87 versus 2.36 ± 7.6, p = 0.02) while improvement in mental composite score was higher in transcatheter aortic valve replacement (8.19 ± 8.50) versus surgical aortic valve replacement (1.18 ± 7.23, p = 0.02). There was no significant difference between the two groups in improvement in psychosocial measures. Conclusion Cardiac rehabilitation enrollment was low in transcatheter aortic valve replacement patients versus surgical aortic valve replacement patients despite similar referral rates. Improvement in functional and quality-of-life performance was achieved in both transcatheter aortic valve replacement and surgical aortic valve replacement. Future studies should address obstacles for enrollment of transcatheter aortic valve replacement patients.

Introduction Data regarding clinical outcomes after transcatheter aortic valve replacement (TAVR) vs surgical aortic valve replacement (SAVR) in patients with sarcoidosis is lacking. This study aims to clarify the clinical outcomes of TAVR vs SAVR in patients with sarcoidosis. Methods Data was collected from the National Inpatient Sample database from 2016-2019 using validated ICD-10-CM codes for sarcoidosis, TAVR, and SAVR. Patients were divided into two cohorts: those who underwent TAVR and those who underwent SAVR. Statistical analysis was performed using Pearson's chi-squared test to determine clinical outcomes of TAVR vs SAVR in patients with sarcoidosis. Results The prevalence of sarcoidosis was 0.23%among total study patients (n=142,420,378). After exclusions, the prevalence of TAVR was 650 (49%) and SAVR was 675 (51%) in patients with sarcoidosis. Patients who underwent TAVR were on average older (74 vs 65 years old, p=0.001), and more likely to be female (57 vs 40%, p<0.001) compared to patients who underwent SAVR. The TAVR cohort had higher rates of congestive heart failure (CHF) (77.7 vs 42.2%, p=0.001), chronic kidney disease (CKD) (42.3 vs 24.4% p=0.001), anemia (5.4 vs 2.2%, p=0.004), percutaneous coronary intervention (PCI) (1.5 vs 0%, p=0.004), and hypothyroidism (31.5 vs 16.3%, p=0.001) compared to the SAVR cohort. Inpatient mortality post-procedure was higher in the SAVR cohort compared to the TAVR cohort (15 vs 0, p=0.001). Regarding post-procedure complications, respiratory complications were more common in the SAVR cohort (4.4 vs 0%, p=0.001), while TAVR was associated with a higher incidence of permanent pacemaker (PPM) insertion (2.15 vs 0.8%, p=0.001). There was no statistical difference in the development of acute kidney injury (AKI) (0.8 vs 1.5%, p=0.33), AKI requiring hemodialysis (0 vs. 0.7%, p=0.08), or stroke (0.8 vs 0.7, p=1) post-procedure between the two cohorts. Conclusion This study found that in the sarcoidosis population, TAVR was associated with reduced mortality, shorter hospital length of stay, and lower hospitalization costs in comparison to SAVR.

To assess the in-hospital outcomes of transcatheter aortic valve replacement (TAVR) vs. surgical aortic valve replacement (SAVR) in non-teaching hospitals. TAVR has become widely available in the United States. However, the comparative outcomes of TAVR vs. SAVR in non-teaching hospitals are largely under explored. We queried the Nationwide Inpatient Sample database from 2011 to September 2015 to identify those who were 50 years or above and underwent either trans-arterial TAVR or SAVR at non-teaching hospital. In-hospital clinical outcomes were compared with odds ratio (OR) in propensity-matched cohorts. We identified un-weighted 957 and 7,465 SAVR admissions. In propensity-matched model, 596 admissions in each arm were included for final analysis. In-patient mortality (3.9 vs. 2.5%, OR 1.54, P = 0.34), acute kidney injury requiring dialysis (2.2 vs. 2.7%, OR 0.80, P = 0.57), stroke (2.0 vs. 3.2%, OR 0.61, P = 0.20), and pacemaker placement (8.9 vs. 6.4%, OR 1.47, P = 0.09) was similar between TAVR and SAVR. Sub-group analysis showed that female and those with prior coronary artery bypass surgery had higher risk of in-patient morality in TAVR admission. Cost was higher (59,103 vs. 53,411 dollars, P = 0.006) but length of stay was shorter in TAVR (6.9 vs. 10.2 days, P < 0.001). TAVR conferred similar in-hospital mortality and major peri-procedural complications compared with SAVR in non-teaching hospitals. For those with limited access to teaching hospitals, non-teaching hospitals appear to be a reasonable option for candidates of aortic valve replacement for severe aortic stenosis.

The optimal treatment in patients with severe aortic stenosis and small aortic annulus (SAA) remains to be determined. This study aimed to compare the hemodynamic and clinical outcomes between transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) in patients with a SAA. This prospective multicenter international randomized trial was performed in 15 university hospitals. Participants were 151 patients with severe aortic stenosis and SAA (mean diameter <23 mm) randomized (1:1) to TAVR (n=77) versus SAVR (n=74). The primary outcome was impaired valve hemodynamics (ie, severe prosthesis patient mismatch or moderate-severe aortic regurgitation) at 60 days as evaluated by Doppler echocardiography and analyzed in a central echocardiography core laboratory. Clinical events were secondary outcomes. The mean age of the participants was 75.5±5.1 years, with 140 (93%) women, a median Society of Thoracic Surgeons predicted risk of mortality of 2.50% (interquartile range, 1.67%-3.28%), and a median annulus diameter of 21.1 mm (interquartile range, 20.4-22.0 mm). There were no differences between groups in the rate of severe prosthesis patient mismatch (TAVR, 4 [5.6%]; SAVR, 7 [10.3%]; P=0.30) and moderate-severe aortic regurgitation (none in both groups). No differences were found between groups in mortality rate (TAVR, 1 [1.3%]; SAVR, 1 [1.4%]; P=1.00) and stroke (TAVR, 0; SAVR, 2 [2.7%]; P=0.24) at 30 days. After a median follow-up of 2 (interquartile range, 1-4) years, there were no differences between groups in mortality rate (TAVR, 7 [9.1%]; SAVR, 6 [8.1%]; P=0.89), stroke (TAVR, 3 [3.9%]; SAVR, 3 [4.1%]; P=0.95), and cardiac hospitalization (TAVR, 15 [19.5%]; SAVR, 15 [20.3%]; P=0.80). In patients with severe aortic stenosis and SAA (women in the majority), there was no evidence of superiority of contemporary TAVR versus SAVR in valve hemodynamic results. After a median follow-up of 2 years, there were no differences in clinical outcomes between groups. These findings suggest that the 2 therapies represent a valid alternative for treating patients with severe aortic stenosis and SAA, and treatment selection should likely be individualized according to baseline characteristics, additional anatomical risk factors, and patient preference. However, the results of this study should be interpreted with caution because of the limited sample size leading to an underpowered study, and need to be confirmed in future larger studies. URL: https://www.clinicaltrials.gov; Unique identifier: NCT03383445.

Hepatologists often determine whether transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) is preferred for patients with cirrhosis and severe aortic stenosis. The goal of this cohort study is to compare outcomes following TAVR and SAVR in patients with cirrhosis to inform the preferred intervention. Prospectively collected data on 105 consecutive patients with cirrhosis and aortic stenosis who underwent TAVR (n=55) or SAVR (n=50) between 2008 and 2016 were reviewed retrospectively. Two control groups were included: 2,680 patients without cirrhosis undergoing TAVR and SAVR and 17 patients with cirrhosis who received medical therapy alone. Among the 105 patients with cirrhosis, the median Society of Thoracic Surgeons score was 3.8% (1.5, 6.9), and the median Model for End-Stage Liver Disease (MELD) score was 11.6 (9.4, 14.0). The TAVR group had similar in-hospital (1.8% vs. 2.0%) and 30-day mortality (3.6% vs. 4.2%) as the SAVR group. During the median follow-up of 3.8 years (95% confidence interval, 3.0-6.9), there were 63 (60%) deaths. MELD score (adjusted hazard ratio, 1.13; 95% confidence interval, 1.05-1.21; P=0.002) was an independent predictor of long-term survival. In the subgroup of patients with MELD score <12, the TAVR group had reduced survival compared with the SAVR group (median survival of 2.8 vs. 4.4 years; P=0.047). However, in those with MELD score ≥12, survival after TAVR, SAVR, and medical therapy was similar (1.3 vs. 2.1 vs. 1.6years, respectively; P=0.53). In select patients with cirrhosis, both TAVR and SAVR have acceptable and comparable short-term outcomes. MELD score, but not Society of Thoracic Surgeons score, independently predicts long-term survival after TAVR and SAVR. For patients with MELD score <12, SAVR is a preferred procedure; however, neither procedure appears superior to medical therapy in patients with MELD score ≥12.