High-risk Transcatheter Aortic Valve Implantation Research Articles

Combined use of VA-ECMO and Impella (ECPELLA) improves short- and long-term mortality in patients with cardiogenic shock who received VA-ECMO

Abstract Introduction Veno-arterial extracorporeal membrane oxygenation (VA-ECMO) is beneficial for patients with refractory cardiac arrest and cardiogenic shock. Despite its benefits, VA-ECMO increases left ventricular (LV) afterload and causes pulmonary edema and LV distension. Recently, a transcatheter left ventricular assist device, Impella has been introduced and potential benefits of the concomitant use of VA-ECMO and Impella (ECPELLA) are expected. However, with the concomitant increase in complications, the utility of ECPELLA remains controversial and unsettled. Objective This single-site cohort study aimed to assess the impact of ECPELLA compared to VA-ECMO with or without intra-aortic balloon pump (IABP) in patients with refractory cardiogenic shock, including cardiac arrest, who received VA-ECMO treatment. Methods We retrospectively reviewed 245 consecutive patients, who underwent VA-ECMO treatment between January 2012 and December 2021 at our institute. Seventeen patients for difficult weaning from cardiopulmonary bypass (n = 15) and as a backup during high-risk transcatheter aortic valve implantation (n = 2) were excluded. The patients were divided into two groups, ECEPLLA (n = 64) and VA-ECMO with or without IABP (n = 164). We performed propensity score analysis with 1:1 score matching using dependent variables of age, the rate of male gender, acute coronary syndrome, out-of-hospital and in-hospital cardiac arrest, and extracorporeal cardiopulmonary resuscitation. We evaluated hemodynamic data, safety profiles, and mortality. Results Following matching, 58 ECPELLA and 58 VA-ECMO patients were included for analysis. No significant differences in the adjusted factors and comorbidities were found between the two groups, except for a significantly higher prevalence of chronic kidney disease in the VA-ECMO group compared to the ECPELLA group. Seventy-one percent of patients received concomitant use of IABP in the VA-ECMO group. During the first 72 hours following the initiation of VA-ECMO, the ECPELLA group received a significantly higher total mechanical circulatory support flow and correspondingly less administration of catecholamines compared with the VA-ECMO group. There were no statistical differences in safety profiles, except for hemolysis and embolic cerebral infarction, between the treatment groups. Kaplan-Meier analysis demonstrated that the 30-day and 1-year survival rates were significantly higher in the ECPELLA group than in the VA-ECMO group. Multivariate cox proportional hazard analysis revealed that age (hazard ratio [HR], 1.36 [10 years increase]; 95% confidence interval [CI], 1.15–1.62, p < 0.001), lactate level at ER (HR 1.07; 95% CI 1.03–1.12, p = 0.001), and ECPELLA (HR, 0.47, 95% CI, 0.30–0.73, p = 0.008) were significantly associated with the 1-year mortality. Conclusion ECPELLA was associated with improvement of short- and long-term mortality in patients with refractory cardiogenic shock who received VA-ECMO.Total MCS flow index and VISKaplan-Meier for 1-year mortality

Transcatheter Aortic Valve Implantation in Two High-Risk Patients with Low Coronary Ostial Heights Using the Novel Balloon-Expandable Myval Valve

The treatment of severe aortic stenosis by transcatheter aortic valve implantation (TAVI) is challenging in patients with high-risk coronary anatomy that is predisposed to iatrogenic or delayed coronary obstruction. Hence, the evidence on performing TAVI with adequate coronary protection with or without deploying a stent needs to be accumulated. We report two cases of TAVI performed in patients with low coronary heights, wherein a “wire only” strategy was used to provide coronary protection along with the implantation of a novel balloon-expandable Myval THV. The first patient underwent a valve-in-valve TAVI, while the second patient underwent the replacement of a native bicuspid Type 1A valve. This case series presents two high-risk TAVI cases wherein a guide extension catheter and a supportive coronary guidewire provided sufficient coronary protection. None of the cases required any rescue revascularization and no incidences of a new pacemaker implantation were reported.

Risk-related short-term clinical outcomes after transcatheter aortic valve implantation and their impact on early mortality: an analysis of claims-based data from Germany

ObjectivesWe aimed to define and assess risk-specific adverse outcomes after transcatheter aortic valve implantation (TAVI) in an all-comers patient population based on German administrative claims data.MethodsAdministrative claims data of patients undergoing transvascular TAVI between 2017 and 2019 derived from the largest provider of statutory health-care insurance in Germany were used. Patients’ risk profile was assessed using the established Hospital Frailty Risk (HFR) score and 30-day adverse events were evaluated. Multivariable logistic regression models were applied to investigate the relation of patients’ risk factors to clinical outcomes and, subsequently, of clinical outcomes to mortality.ResultsA total of 21,430 patients were included in the analysis. Of those, 51% were categorized as low-, 37% as intermediate-, and 12% as high-risk TAVI patients according to HFR score. Whereas low-risk TAVI patients showed low rates of periprocedural adverse events, TAVI patients at intermediate or high risk suffered from worse outcomes. An increase in HFR score was associated with an increased risk for all adverse outcome measures. The strongest association of patients’ risk profile and outcome was present for cerebrovascular events and acute renal failure after TAVI. Independent of patients’ risk, the latter showed the strongest relation with early mortality after TAVI.ConclusionsDifferentiated outcomes after TAVI can be assessed using claims-based data and are highly dependent on patients’ risk profile. The present study might be of use to define risk-adjusted outcome margins for TAVI patients in Germany on the basis of health-insurance data.Graphical abstract

Midterm outcomes of transaortic and transapical TAVI in patients with unsuitable vascular anatomy for femoral access: A propensity score inverse probability weight study.

Transaortic (TAo) and transapical (TA) implantation can be used in transcatheter aortic valve implantation (TAVI) when the transfemoral (TF) approach is precluded. We compare the safety and efficacy of these alternative techniques. From October 2007 to February 2016, TAo and TA patients' data were collected. Propensity score inverse probability of treatment weight (IPTW) method was employed to minimize the impact of no-randomization bias. From our single-center non-TF-TAVI registry, 282 patients were included: 235 (83.3%) underwent TAo and 47 (16.7%) TA. Differences in baseline characteristics were statistically significant in age, sex, risk profile according to logistic-EuroSCORE, and previous cardiac surgery. No difference in hospital morbidity and mortality, but lower stroke-rate in TAo (1.27% vs. 8.5% p < .01) was observed. This was confirmed at logistic regression after IPTW adjustment (odds ratio [OR]: 0.16, 95% CI 0.03-0.71, p = .01), together with reduced risk of the paravalvular leak (PVL) (OR: 0.14, 95% confidence interval [CI]: 0.02-0.81, p = .02). Kaplan-Meier estimates did not demonstrate differences in long-term mortality among access routes (logrank test p = .13). At the IPTW-Cox regression model, long-term mortality was related to New York Heart Association III-IV (hazard ratio [HR]: 2.92, 95% CI: 1.15-7.40, p = .026), chronic renal failure (HR: 3.25; 95% CI: 1.02-10.32 p = .046), previous transient ischemic attack/stroke (HR: 2.29, 95% CI: 1.25-4.20 p = .007). Sapien-3 device resulted to be a protective factor, reducing long-term mortality (HR: 0.18, 95% CI 0.04- 0.90 p = .03). TAo is safe and feasible in case of contraindication to femoral approach demonstrating comparable midterm outcomes to TA, thus representing a central access alternative, to increase the overall safety of high-risk TAVI procedures.

Successful Reoperation in 3 Cases of Failed Sorin Freedom Stentless Aortic Valve Using the LivaNova Perceval Sutureless Prosthesis.

Reoperations for deteriorated stentless bioprostheses are quite challenging procedures. Calcification of the aortic annulus and of the subcoronary root makes often impossible the removal of the failed valve, living a complex Bentall operation or a high-risk transcatheter aortic valve implantation valve-in-valve procedure as the only options, particularly in cases of small-size prostheses. The Perceval sutureless prosthesis (LivaNova PLC, London, UK) can be a valid alternative for failed stentless valve replacement. We report our experience with 3 complex cases of degenerated Sorin Pericarbon Freedom prosthesis treated successfully by means of Perceval sutureless implantation and demonstrating the reproducibility and the safety of this surgical approach.

Prognostic influence of acute decompensated heart failure in patients planned for transcatheter aortic valve implantation.

The aim of our study was to evaluate the outcome of patients with severe aortic stenosis presenting with acute decompensated heart failure (ADHF) and planned for transcatheter aortic valve implantation (TAVI) and to study the variables influencing their prognosis. Our retrospective study included 801 patients planned for TAVI in our center. Seven hundred and fifty-six underwent TAVI and were categorized according to ADHF as the initial clinical presentation into two groups: ADHF group (n = 261) and no-ADHF group (n = 495). Pre as well as periprocedural outcomes and 1 year mortality were analyzed. Among the patients planned for the TAVI procedure, 45 patients remained untreated: 35 patients died while waiting to undergo TAVI which represented 20% of all deaths in our study, ADHF was observed in 23 of 45 (51%) these untreated patients. The 1-year all-cause mortality rate was significantly higher in the ADHF group versus the no-ADHF group (27% vs. 15%, p < .0001). In multivariate analysis, male gender (odds ratio [OR] =2.5, 95% confidence interval [CI]: 1.37-4.57, p = .03), body mass index <25 kg/m2 (OR = 2.76, 95% CI: 1.51-5.04, p = .0009), and logistic EuroSCORE II ≥20% (OR = 3.04, 95% CI: 1.56-5.94, p = .001) were associated with a higher 1-year mortality in the ADHF group. The patients eligible for TAVI presenting with ADHF were associated with a higher mortality for both: while on the waiting list for TAVI as well as at 1-year follow-up and thus asking for clearer criteria to prioritize action in this high-risk TAVI patients.

P5579Pre-existing depression significantly improves after transcatheter aortic valve implantation (TAVI): analysis of long-term effects and screening for novel biomarkers

Abstract Background and aims Depression negatively affects symptom tolerance as well as clinical endpoints in cardiovascular diseases. For aortic stenosis (AS) patients undergoing Transcatheter Aortic Valve Implantation (TAVI), a reduction of pre-existing depression and anxiety in short term follow-up could be recently shown by our group. The current study was aimed to evaluate these effects in long-term follow-up and to screen for promising biomarkers, e.g., 5-Hydroxytryptamin (5-HT), Endothelin-1 (ET-1), neutrophil gelatinase associated lipocalin (NGAL) and Tenascin-C (Tn-C) variants. These molecules might reflect a pathophysiological link between reverse cardiac remodelling and mental state. Methods The study included 182 out of 226 patients who underwent TAVI at the University Hospital Jena since August 2016. Besides clinical parameters, the EuroQol questionnaire (EQ-5D), the Visual Analog Scale (VAS), the Clinical Frailty Scale (CFS) and, to specifically detect depression and anxiety, the Hospital Anxiety and Depression Scale (HADS-D) were assessed directly before TAVI, at 6-weeks, 6-month as well as 12- months follow-up. Blood samples were withdrawn before TAVI and during 6-weeks and 6-month follow-up. Results Study patients represented a typical moderate- to high-risk TAVI collective (n=182, mean age 78,1±7.9 years, 46,9% male, mean STS-Score 4.6±2,8). Before TAVI, analysis of HADS revealed ≥8 points, defined as pathologic, for depression and/or anxiety in 71 patients (39%) and for depression only in 46 patients (25.3%). In the depressive subgroup, there was a significant improvement after 6 weeks for depression (p&lt;0.001) and anxiety (p=0.006). BNP serum levels were significantly reduced (p=0.007) and 6-minutes' walk distance was significantly increased from a low level (p=0.008), VAS, CFS and 2 out of 5 parameters of the EQ-5D were significantly improved (p&lt;0.05). All observed short-term effects continued at stable levels over time. A pre-existing depression state was not associated with an increased long-term mortality rate, which was 14.8%. Circulating biomarker levels in depressive patients before and 6 weeks after TAVI revealed no significant differences. At the 6 months follow-up, only for C+ Tn-C there was a significant increase compared to both, the timepoint before TAVI (p=0.046) and the 6 weeks follow-up (p=0.033). Conclusions Already in short-term follow-up after successful TAVI, a remarkable decrease in depression could be detected using HADS. Especially in the depressive subgroup, the patients showed benefit also with respect to other surrogate parameters of mental health and functional performance. Interestingly, these effects were completely maintained not only in mid-term but also in long-term follow-up. We could show that the improvement of depression after TAVI is reflected by a delayed decrease of C+ Tn-C serum levels. C+ Tn-C can be suggested as promising biomarker possibly linked to reactive depression in somatic diseases.

Comparison of Early Outcomes in Low-, Intermediate- and High-Risk Transcatheter Aortic Valve Implantation Patients

Comparison of Early Outcomes in Low-, Intermediate- and High-Risk Transcatheter Aortic Valve Implantation Patients

Extracorporeal membrane oxygenation for very high-risk transcatheter aortic valve implantation

Introduction: Transcatheter aortic valve implantation (TAVI) can cause profound haemodynamic perturbation in the peri-operative period. Veno-arterial extracorporeal membrane oxygenation (ECMO) can be used to provide cardiorespiratory support during this time, either prophylactically or emergently. Methods: 100 TAVI procedures were performed between 2009 and 2013 in our institution. ECMO was used in 11 patients, including 8 prophylactic and 3 rescue cases. Rescue ECMO was required for ventricular fibrillation after valvuloplasty, and aortic annulus rupture. The criteria for prophylactic ECMO included heart failure requiring stabilisation pre-TAVI, haemodynamic instability with balloon aortic valvuloplasty performed to improve heart function pre-TAVI, moderate or severe left and/or right ventricular failure, or borderline haemodynamics at procedure. Differences in preoperative characteristics and postoperative outcomes between ECMO and non-ECMO TAVI patients were compared, and significant results were further assessed controlling for EuroSCORE. Results: Compared to TAVI patients who did not require ECMO, ECMO patients had significantly higher mean EuroSCORE (51 vs. 30%, p<.05). All-cause mortality occurred in nil prophylactic ECMO patients, one rescue ECMO patient, and two non-ECMO patients. The difference in mortality between ECMO and non-ECMO patients was not significantly different (9 vs. 2%; p>.05). Other non-significant outcomes (p<.05) included peri-procedural and spontaneous myocardial infarction (0 vs. 2% and 0 vs. 0%, respectively); disabling and non-disabling stroke (0 vs. 0% and 0 vs. 2%, respectively); transient ischaemic attack (0 vs. 0%); life-threatening, major and minor bleeding (12 vs. 3%, 0 vs. 12% and 38 vs. 13%, respectively); and major and minor vascular complications (12 vs. 5% and 0 vs. 13%, respectively). ECMO patients were more likely to develop acute renal failure than non-ECMO patients (36 vs. 8%, p<.05), which was most likely due to haemodynamic collapse and end-organ dysfunction in patients that required emergent ECMO rescue. Discussion: ECMO, in both prophylactic and rescue settings, is effective at providing cardiorespiratory support in very-high risk TAVI patients, and may have contributed to the low mortality in this series. Instituting prophylactic ECMO in an elective, controlled setting may help avoid consequences of intraoperative complications such as systemic hypoperfusion and acute renal failure, compared to emergent ECMO with rapid setup and cannulation. Limitations of this study include small patient sample size and observational nature. Future studies performed in a prospective, randomised fashion are required to evaluate the use of prophylactic ECMO, and to determine the ideal selection criteria.

98 Lack of Consensus on Anti-thrombotic Therapy in Patients Undergoing Tavi – an Online Survey from Uk Tavi Operators

IntroductionThe incidence of cerebrovascular ischaemic events during and early after Trans-catheter Aortic Valve Implantation (TAVI) procedure remains a major concern. Peri-procedural events may be due to embolization of calcified material...

Elective use of femoro-femoral cardiopulmonary bypass during transcatheter aortic valve implantation†

Elective use of normothermic cardiopulmonary bypass (CPB) may reduce the risks associated with the transcatheter aortic valve implantation (TAVI) procedure in selected high-risk TAVI patients. Between April 2008 and August 2013, 1177 consecutive patients underwent TAVI. Elective normothermic femoro-femoral CPB was used in 3.7% of patients (n=43, 27 males, 16 females; mean age 75±10 [range 38-90] years). The EuroSCORE I was 65±23%, the EuroSCORE II was 39±24% and the Society of Thoracic Surgeons Predicted Risk of Mortality score was 31±24%. The mean left ventricular ejection fraction (LVEF) was 24±12% (range 5-50%). The device success rate (Valve Academic Research Consortium-2 criteria) was 98% in this study group. The median duration of CPB was 20 (range 5-297) min. In 20 patients with pulmonary hypertension combined with an enlarged right ventricle (RV), or with poor RV ejection fraction or LVEF (mean LVEF: 18±3% [range 10-20%]), CPB was used to prevent haemodynamic instability during valve deployment and to eliminate the adverse effects of possible ventricular fibrillation. Additionally, it was used to promote cardiac recovery by unloaded failing hearts in 23 patients (53%) with cardiogenic shock. Whereas the 30-day mortality rate in the group of patients in cardiogenic shock was 28.6%, no patient in the other group died. The 1-year survival rate was 36±11 and 86±9.5%, respectively. The use of preoperatively planned CPB may increase the safety of the TAVI procedure in patients with severely reduced heart function or in cardiogenic shock.

241 * ELECTIVE USE OF FEMORO-FEMORAL CARDIOPULMONARY BYPASS DURING TRANSCATHETER AORTIC VALVE IMPLANTATION

Objectives: Elective use of normothermic cardiopulmonary bypass (CPB) may reduce the risk of a transcatheter aortic valve implantation (TAVI) procedure in selected high-risk TAVI patients. Methods: Between April 2008 and March 2013, 1040 consecutive patients underwent TAVI. Elective normothermic femoro-femoral CPB was used in 4.4% of patients (n = 46, 26 men and 20 women; mean age 73 ± 13 [range 34-90] years). The EuroSCORE I was 64 ± 25%, the EuroSCORE II was 42 ± 24% and the STS PROM score was 32 ± 25%. The mean left ventricular ejection fraction (LVEF) was 26 ± 16% (range 10-74). Results: The technical success rate was 100%. Duration of cardiopulmonary bypass was 68 ± 102 min (range 6-628). In 13 patients with poor RVEF or LVEF (mean LVEF 18 ± 5% [range 10-30]), CPB was used to prevent haemodynamic instability during valve deployment and to eliminate the consequences of possible ventricular fibrillation. Additionally, it was used for recovery of the unloaded heart in 25 patients with cardiogenic shock. The 30-day mortality was 13% and one-year survival was 52%. Conclusions: The use of preoperatively planned CPB enhances the safety of the TAVI procedure in patients with severely reduced heart function or in cardiogenic shock.

Rehospitalization rates after transcatheter aortic valve implantation

Comorbidities pose a major challenge to screening, selection and follow-up of transcatheter aortic valve implantation (TAVI) patients as well as to the procedure itself. The aim of the present study was to assess cardiac and non-cardiac readmission rates besides clinical endpoint data in the first 50 patients of a single center TAVI programme. TAVI was performed using the transfemoral CoreValve system. Procedural success rate was 94%; intraprocedural mortality was 2%. 82% of the patients remained free of a combined safety endpoint at 30 days, and 76.1% remained free of a combined efficacy endpoint at six months (modified criteria of the Valve Academic Research Consortium). At six months, among all surviving patients, 10.3% had experienced readmissions for cardiac causes, and 43.6% had experienced readmissions for non-cardiac causes. Causes of non-cardiac readmissions showed a wide distribution over various medical disciplines, reflecting the high rate of comorbidities. Beyond six months until a predefined reference date (mean follow up 9.9 months), the probability of hospitalization fell by half (1.54 vs. 0.74 hospital days per patient per month), driven by a decrease of non-cardiac readmissions. Karnofsky score before and after TAVI yielded a significant and sustained improvement of performance status, as assessed retrospectively at reference date. The findings of the present study suggest that the high prevalence of comorbidities in high-risk TAVI patients results in a high rate of non-cardiac rehospitalizations during the first 6 months of follow-up. Despite this fact, improvement of global everyday performance following TAVI as perceived by the patients seems to be substantial.