Transcatheter Aortic Valve Implantation in Patients With Super Obesity: Defining a High-Risk Phenotype.

There is still no consensus on the treatment of patients with connective tissue disease (CTD) with severe symptomatic aortic stenosis (AS). The aim of this study was to evaluate the feasibility and safety of transcatheter aortic valve implantation (TAVI) in patients with CTD. Five hundred and fifty consecutive symptomatic severe AS patients who underwent TAVI between 2011 and 2019 were included in this retrospective study, of whom 14 had CTD. Follow-up was performed 30 days, 6 months, and 1 year after the procedure. Of the 14 (2.5%) patients who had CTD, most had rheumatoid arthritis (n = 10), followed by lupus erythematosus (n = 2), scleroderma (n = 1) and mixed (n = 1) CTD. The mean age was 77.6 ± 7.9 years, and there was no statistical difference between the CTD and no-CTD groups. In addition, significantly more of the CTD patients (85.7%) were female compared to the no-CTD group (p = 0.018). None of the patients in the CTD group had acute kidney injury, stroke, major bleeding, or pericardial effusion. However, significantly more patients in the CTD group (n = 4) needed permanent pacemaker implantation than in the no-CTD group (p = 0.008). There were no significant differences between the two groups in terms of mean discharge time (CTD 4.6 ± 2.0, no-CTD 4.5 ± 2.3 days, p = 0.926) and in-hospital mortality [CTD 1 (7.1%), no-CTD 21 (3.9%); p = 0.542]. In this study, we presented the results of TAVI in patients with and without CTD. The TAVI procedure had similar mid-term outcomes in the two groups, and the CTD group had numerically lower rates of major complications at the cost of a higher incidence of pacemaker implantation.

Transcatheter aortic valve implantation (TAVI) in patients with low coronary heights is generally denied but is not impossible. Information about these high-risk procedures is sparse. Since May 2008, data of more than 3000 patients who had TAVI were prospectively collected in the institutional TAVI Karlsruhe registry. Characteristics, peri- and postoperative outcome of patients with low coronary heights of ≤7 mm were analysed according to the Valve Academic Research Consortium-2. Eighty-six patients with an average coronary height of 6.4 ± 1.1 mm (mean age 81.0 ± 5.3 years, logistic EuroSCORE I 19.6 ± 13.3%) were treated. TAVI was performed in 72 transfemoral (83.7%) and 14 transapical (16.3%) cases using 44 CoreValve/Evolut R (51.2%), 21 Sapien XT/S3 (24.4%), 14 ACURATE (16.3%), 5 Lotus (5.8%) and 2 Portico (2.3%) prostheses. Ten procedures were valve-in-valve (VinV) TAVI (VinV, 11.6%). The 72-h, 30-day, 1-year and follow-up (3.0 ± 1.6 years) mortality rates were 2.3%, 8.0%, 10.5% and 26.7%, respectively. Within 30 days, 4 cardiac deaths and 3 non-cardiac deaths occurred (4.7% and 3.5%). Three coronary obstructions (3.5%) occurred-2 during VinV TAVI. One patient was connected to extracorporeal circulation that could not be weaned later due to an unsuccessful percutaneous coronary intervention. Another patient, the only conversion (1.2%), required delayed surgical valve replacement. The third patient died of right heart failure after aortic dissection. The procedural success rate was 95.3%. VinV procedures were associated with increased follow-up deaths (P < 0.001; hazard ratio 7.96). Coronary-related complications in TAVI procedures in patients with coronary heights ≤7 mm occurred less frequently, but once they occurred, they were serious. These TAVI procedures are feasible, with a high procedural success rate, but meticulous preoperative planning should be mandatory. In VinV procedures, the follow-up mortality rate is increased; therefore, we do not recommend these procedures.

Outcomes After Transcatheter Aortic Valve Implantation in Patients Excluded From Clinical Trials

ObjectiveThe objective was to assess the cost-effectiveness of transcatheter aortic valve implantation (TAVI) in patients with severe aortic stenosis with intermediate surgical risk in Singapore.MethodsA de novo Markov model with three health states – stroke with long-term sequelae, no stroke, and death – was developed and simulated using Monte Carlo simulations with 10,000 iterations over a five-year time horizon from the Singapore healthcare system perspective. A 3% annual discount rate for costs and outcomes and monthly cycle lengths were used. By applying the longest available published clinical evidence, simulated patients received either TAVI or surgical aortic valve replacement (SAVR) and were at risk of adverse events (AEs) such as moderate-to-severe paravalvular aortic regurgitation (PAR).ResultsWhen five-year PARTNER 2A data was applied, base-case analyses showed that the incremental cost-effectiveness ratio (ICER) for TAVI compared to SAVR was US$315,760 per quality-adjusted life year (QALY) gained. The high ICER was due to high incremental implantation and procedure costs of TAVI compared to SAVR, and marginal improvement of 0.10 QALYs as simulated mortality of TAVI exceeded SAVR at 3.75 years post-implantation. One-way sensitivity analysis showed that the ICERs were most sensitive to cost of PAR, utility values of SAVR patients, and cost of TAVI and SAVR implants and procedures. When disutilities for AEs were additionally applied, the ICER decreased to US$300,070 per QALY gained. TAVI was dominated by SAVR when the time horizon increased to 20 years. Clinical outcomes projected from one-year PARTNER S3i data further reduced the ICER to US$86,337 per QALY gained for TAVI, assuming early all-cause mortality benefits from TAVI continued to persist. This assumption was undermined when longer term data showed that TAVI’s early mortality benefits diminished at five years.Limitations and conclusionTAVI is unlikely to be cost-effective in intermediate surgical-risk patients compared to SAVR in Singapore.

Transcatheter Aortic Valve Implantation During the COVID-19 Pandemic

Funding Acknowledgements Type of funding sources: None. Background. There are limited data about the intraprocedural hemodynamic study performed immediately before and after transcatheter aortic valve implantation (TAVI) in patients with severe aortic stenosis (AS). Purpose. We aimed to evaluate the acute hemodynamic impact of TAVI in patients with severe AS and to investigate invasive and non-invasive parameters predicting all-cause mortality. Methods. A total of 245 consecutive AS patients undergoing TAVI were enrolled. Intraprocedural left heart catheterization (LHC) and echocardiogram before and after TAVI were performed. The clinical endpoint was the death for any cause. Results. LHC after TAVI revealed significant changes in aortic and LV pressures, including indexes of intrinsic myocardial contractility and diastolic function such as positive dP/dT (1128.9 ± 398.7 vs 806.3 ± 247.2 mmHg/sec, p˂0.001; Figure 1A) and negative dP/dT (1310.7± 431.1 vs 1075.1 ± 440.8 mmHg/sec, p˂0.001; Figure 1B). Post TAVI echo showed a significant reduction in LV end diastolic volume index (54.6 ± 18.4 ml/m2 vs 51.7 ± 17.5 ml/m2; p = 0.017; Figure 1C), improvement in left ventricle ejection fraction (from 55 ± 12 to 57.2 ± 10.5%, p˂0.001; Figure 1D) and pulmonary artery systolic pressure (42.1 ± 14.2 vs 33.1 ± 10.7 mmHg, p &amp;lt; 0.001; Figure 1E). After a mean follow-up time interval of 24 months, 47 patients died. Post-TAVI aortic regurgitation (2- 3- 4+) at echocardiography was the only independent predictor of mortality (HR 4.43, C.I. 1,71 – 11,45, p = 0.002; Figure 2). Conclusions. LHC performed immediately before and after prosthesis release offers a unique insight in the assessment ofLV adaptation to severe AS and the impact of TAVI on LV, catching changes in indexes of intrinsic contractility and myocardial relaxation. Aortic regurgitation assessed by echocardiography was the only independent predictor of mortality in patients undergoing TAVI. FIGURE LEGEND Figure 1. A-B: Impact of TAVI on haemodynamic parameters: Box plot with median and interquartile ranges of positive dP/dT and negative dP/dT values pre vs post TAVI. C-D-E: Impact of TAVI on echocardiographic parameters: Box plot with median and interquartile ranges of left ventricular end diastolic volume index (LVEDVi), left ventricular ejection fraction (EF) and pulmonary artery systolic pressure (PASP) values pre vs post TAVI. Figure 2. Kaplan-Meier curves for survival showing that AR (2-3-4+) assessed with echocardiography had the strongest association with mortality. Abstract Figure 1. Abstract Figure 2.

Background Global longitudinal strain (GLS) has incremental value in assessing left ventricular (LV) function in patients with severe aortic stenosis (AS). Long-standing AS causes LV hypertrophy which predisposes to increased cardiac morbidity and mortality. The recent development of transcatheter aortic valve implantation (TAVI) device for treatment of severe symptomatic AS, offers an option for high risk patients. Objectives Our aim was to investigate the correlation between the time elapsed after performing a TAVI procedure and the LV GLS by Speckle tracking echocardiography (STE) and its correlation with progressive degree of regression in LV mass (LVM) by transthoracic echocardiography (TTE). Methods TTE was performed on 54 patients with severe AS who underwent TAVI procedure. TTE was performed at baseline (before the procedure) and then at 3 months and 6 months post TAVI. GLS was calculated for every patient from STE of the three apical views (apical 4, apical 2 and apical long axis views). The LV muscle volume was calculated by subtraction of LV pericardial volume from LV endocardial volume using biplane Simpson's formula. LVM was then calculated by multiplying LV mass volume by muscle density (1.05). Results The study included 54 patients with severe AS (average PG =79.5 mmHg and average mean gradient 40.5 mmHg), with a mean age of 79±10 years and 46 were male. All patients underwent TAVI and average mean gradient post TAVI was 7 mmHg. The mean ± SD of GLS were −15.3±2.0, −15.9±1.7 and −17.2±1.8 for STE obtained at baseline, 3- and 6-months post TAVI, respectively. There was significant difference in LV GLS when comparing baseline measurements with measurements obtained at both 3 months {mean difference ± SD (MD±SD) was 0.57±0.7 (p&amp;lt;0.001)} and at 6 months post TAVI was 1.8±0.8 (p&amp;lt;0.0001). There was significant difference when comparing LV GLS measurements at 3- and 6- months post TAVI MD±SD was 1.2±0.65 (p&amp;lt;0.001). The mean±SD of LVM was 118.5±31, 110.5±29.2 and 101.1±26.4 at baseline, 3- and 6-months post TAVI, respectively. There was significant difference between baseline and 3 months measurement of LVM, MD±SD is 7.6±6.0 (p&amp;lt;0.001). There was significant difference between baseline and 6 months measurement of LVM, MD±SD was 17.0±10.5 (p&amp;lt;0.0001). In addition, there was significant difference of LVM calculation at 3 and 6 months with MD±SD of 9.4±7.9 and (P&amp;lt;0.001). Conclusions In patient with severe AS that underwent TAVI, there is short term continues significant improvement of LV GLS by STE. This could be attributed to relieving the pressure overload and regression of LVM over time. Decreasing LV hypertrophy and increasing LV GLS on the short term indicate high efficacy of TAVI procedure and subsequently improving patient prognosis and quality of life. Funding Acknowledgement Type of funding source: None

Background: Evidence on the safety of transcatheter aortic valve implantation (TAVI) in End-stage renal disease (ESRD) patients is limited. Methods: The Nationwide Readmissions Database (NRD) from 2015-2019 was queried to identify patients undergoing TAVI in ESRD versus patients with no ESRD. The in-hospital, 30-day, and 180-day outcomes were assessed using a propensity-score matched (PSM) analysis to calculate adjusted odds ratios (aOR). Results: A total of 198,816 underwent TAVI, of which 34,546 patients (TAVI-ESRD:16,986 vs non-ESRD:17,560) were selected on PSM analysis. The adjusted odds of net adverse cardiovascular events (NACE) (aOR 1.65, 95% CI 1.49-1.82), in-hospital mortality (aOR 2.99, 95% CI 2.52-3.55), major bleeding (aOR 1.21, 95% CI 1.05-1.40), postprocedural cardiogenic shock (aOR 1.54, 95% CI 1.11-2.13), permanent pacemaker implantation (PPM) (aOR 1.24, 95% CI 1.15-1.38) were significantly higher in TAVI-ESRD patients compared with non-ESRD patients at index admission. There was no significant difference in the odds of stroke (aOR 1.09, 95% CI 0.86-1.34) and cardiac tamponade (aOR 1.06, 95% CI 0.78-1.45) between two groups. Table 1. At 30-day follow-up, TAVI-ESRD patients had higher odds of major bleeding while there was no significant difference in outcomes of stroke, cardiac tamponade and PPM implantation between the two groups up to 180-day follow-up, Table 2. On trend analysis, the rate of utilization of TAVI in ESRD has significantly increased to 30% by 2019. Conclusion: The rate of utilization of TAVI in ESRD has significantly increased in recent years despite the higher risk of NACE, in-hospital mortality, major bleeding and PPM implantation.

Comparison of Results of Transcatheter Aortic Valve Implantation in Patients With Versus Without Active Cancer

Introduction The aim of this systematic review and meta-analysis was to investigate the efficacy and safety of emergent transcatheter aortic valve implantation (TAVI) in patients with decompensated aortic stenosis (AS) by comparing the clinical outcomes with the patients who had received the elective TAVI. Methods By searching PubMed, EMBASE, and Cochrane databases, we obtained the studies comparing the clinical outcomes of emergent TAVI and elective TAVI. Finally, 14 studies were included. Results A total of 14 eligible articles with 73,484 patients were included in this meta-analysis. Emergent TAVI was associated with a higher mortality during hospitalization (HR 2.09, 95% CI [1.39 to 3.14]), 30 days (HR 2.29, 95% CI [1.69 to 3.10]), and 1 year (HR 1.96, 95% CI [1.55 to 2.49]). Consistently, the incidence of acute kidney injury (AKI) (RR 2.48, 95% CI [1.85 to 3.32]), dialysis (RR 2.37, 95% CI [1.95 to 2.88]), bleeding (RR 1.62, 95% CI [1.27 to 2.08]), major bleeding (RR 1.05, 95% CI [1.00 to 1.10]), and 30-day rehospitalization (RR 1.30, 95% CI [1.07, 1.58]) were more common in patients receiving emergent TAVI. No statistical differences were found in the occurrence rate of vascular complications (RR 1.11, 95% CI [0.90, 1.36]), major vascular complications (RR 1.14, 95% CI [0.52, 2.52]), permanent pacemaker (PPM) placement (RR 1.05, 95% CI [0.99, 1.11]), cerebrovascular events (RR 1.11, 95% CI [0.98, 1.25]), moderate to severe paravalvular leakage (PVL) (RR 1.23, 95% [CI 0.94 to 1.61]), and device success (RR 0.99, 95% CI [0.97, 1.01]). Conclusion Emergent TAVI is associated with some postoperative complications and increased mortality compared with elective TAVI. Emergent TAVI should be implemented cautiously and individually.

Early safety and mid-term clinical outcomes of technology transfer of transcatheter aortic valve implantation in patients with severe aortic valve stenosis in Vietnam: a single-center experience of 90 patients

Transcatheter Aortic Valve Implantation in Patients With Severe Aortic Stenosis Hospitalized With Acute Heart Failure

Untreated symptomatic high-grade aortic stenosis remains a lethal disease. Therefore, a comprehensive evaluation is necessary to obtain the best individual treatment for each patient. Recently, transcatheter aortic valve implantation (TAVI) was developed as an innovative therapy for high-risk and inoperable patients. Persistent thrombocytopenia is an established risk for conventional open heart surgery, but is not covered by traditional surgical risk scores. The aim of the study was the investigation of safety and feasibility of TAVI in patients with severe thrombocytopenia. Because of the complicated outcome of patients with persistent thrombocytopenia undergoing heart surgery, we considered all patients with high-grade aortic stenosis and a thrombocyte count of less than 100 per nl as surgical high-risk patients. Out of these high-risk surgical patients, six patients with symptomatic high-grade aortic stenosis and severe thrombocytopenia were deemed to be TAVI candidates and underwent TAVI procedures in 2010 and 2011 (transfemoral: n = 4; transapical: n = 2) at the University Hospital of Frankfurt. The outcome of these patients was analyzed prospectively in order to document safety and feasibility of TAVI in such patients. All TAVI procedures were performed successfully with excellent functional results. There was no occurrence of major or minor bleeding complications, acute renal failure or nosocomial infection. One patient died of an ischemic stroke 12 days after the procedure. The five remaining patients were alive at the 12-month follow-up without relevant cardiovascular events and excellent valve performance. TAVI is an effective and well tolerated method to treat patients with chronic persistent thrombocytopenia and symptomatic high-grade aortic stenosis, and therefore a reasonable alternative to conventional heart surgery in such patients. The indication for TAVI in patients with thrombocytopenia and symptomatic high-grade aortic stenosis might be generated independently from conventional scoring systems.

Cardiovascular Outcomes of Transcatheter Aortic Valve Implantation in Patients With Chronic Kidney Disease in Octogenarian Population

Limited information is available on outcomes in patients with bicuspid aortic valve (BAV) stenosis undergoing transcatheter aortic valve implantation (TAVI) compared with surgical aortic valve replacement (SAVR), as pivotal randomised trials excluded patients with BAV pathology due to anatomic complexity. The aim of the study was to compare early outcomes between TAVI and SAVR in patients with BAV stenosis. We queried the Nationwide Readmission Database (NRD) between 2016 and 2018 to identify adults who underwent TAVI or SAVR for BAV stenosis. The study's primary outcome was in-hospital mortality. Secondary outcomes were 30-day and six-month major adverse cardiovascular events (MACE). We matched both cohorts using propensity score matching, and applied logistic and Cox-proportional hazard regression to compute the odds ratio (OR), the hazard ratio (HR), and the 95% confidence interval (CI). Out of 17,068 patients with BAV stenosis, 1,629 (9.5%) patients underwent TAVI and 15,439 (90.5%) underwent SAVR. After propensity score matching (PSM), we found 1,393 matched pairs. Of the matched pairs, 848 had complete six-month follow-ups. In the PSM cohort, TAVI was associated with reduced in-hospital mortality (0.7% vs 1.8%, OR: 0.35, 95% CI: 0.13-0.93; p=0.035), and a similar rate of MACE at 30 days (1% vs 1.5%, OR: 0.65, 95% CI: 0.27-1.58; p=0.343) and at six months (4.2% vs 4.9%, HR 0.86, 95% CI: 0.44-1.69; p=0.674), compared with SAVR. In the propensity score-matched cohort, TAVI was associated with reduced odds of in-hospital mortality and a similar risk of 30-day and six-month MACE, supporting the feasibility of TAVI in BAV patients without a need for concurrent aortic root repair.