Transcatheter aortic valve implantation and hybrid coronary artery revascularization: time to combine them

We report on simultaneous off-pump coronary artery bypass grafting to the left anterior descending artery, modified transapical aortic valve implantation, and stenting of the circumflex and right coronary arteries in an 84-year-old patient. The poly-morbid patient with a logistic EuroSCORE of 85% experienced recent myocardial infarction; the left ventricular ejection fraction was reduced to 20%. Postoperative recovery was fast and short. The strategy described is the next logical step in broadening the indication for transcatheter aortic valve interventions.     

Influence of permanent pacemaker implantation after transcatheter aortic valve implantation with new-generation devices

Objective

Permanent pacemaker implantation (PPMI) after transcatheter aortic valve implantation (TAVI) is the most common complication after the procedure. PPMI rates remain high with the new-generation TAVI devices despite improved outcomes concerning paravalvular aortic regurgitation and vascular access complications. However, the impact of PPMI on mortality and clinical outcome is still a matter of debate, and data with new-generation devices on this matter are scarce. Therefore, we sought to analyse the influence of PPMI in patients treated with the new-generation devices on one-year outcome.

Methods

We enrolled 612 consecutive patients without prior pacemaker undergoing transfemoral TAVI with the new-generation devices. Patients with or without PPMI were compared with respect to clinical outcome within one year.

Results

PPMI was performed in 168 patients (24.4% of the overall study population). There was no significant difference in one-year outcome concerning all-cause mortality (PPMI vs. no-PPMI: 12.2% vs. 12.5%, p?=?0.94), rate of major adverse events including cardiac, cerebral or valve-related events and bleeding complications (22.1% vs. 24.5%, p?=?0.55) or need for rehospitalisation due to cardiac symptoms (16.1% vs. 18.1%, p?=?0.63). In patients with reduced ejection fraction (<45%) there was also no impact of PPMI on one-year mortality (14.3% vs. 15.7%, p?=?0.86). Furthermore, multivariate analysis did not reveal PPMI to be independently associated with one-year mortality (odds ratio 0.94, 95% confidence interval 0.50–1.74, p?=?0.83).

Conclusions

In this large all-comers TAVI population with new-generation devices the need for postprocedural PPMI did not show a statistical significant impact on survival or combined endpoint of major adverse events within one year.

     

Long-term outcomes of isolated aortic valve replacement and concomitant AVR and coronary artery bypass grafting

Background

It is well established that concomitant aortic valve replacement (AVR) and coronary artery bypass grafting (CABG) has a higher operative mortality rate than isolated AVR. However, studies report conflicting results on the long-term mortality. The aim of this prospective study was to explore and compare the outcomes and risk factors of isolated AVR and concomitant AVR and CABG in a consecutive Dutch patient population.

Methods

From January 2001 through January 2010, 332 consecutive patients underwent AVR with or without CABG at a single institution (197 isolated AVR and 135 concomitant AVR and CABG). A multivariate Cox proportional hazard analysis was performed to determine the independent risk factors for long-term mortality after aortic valve replacement.

Results

All 332 consecutive, referred patients who underwent aortic valve surgery were followed for up to 10 years. Median follow-up length was 48 months. The population had a median age of 73 years (IQR 65–78) and predominantly consisted of males (62%). Patients in the combined AVR and CABG group were older, had worse cardiac risk profiles and had worse preoperative cardiac statuses than those receiving isolated AVR. Five-year survival was 85% in AVR and 73% in AVR-CABG (p-value 0.012). Independent risk factors for mortality were higher creatinine values, previous CABG and increasing age.

Conclusion

Unselected, consecutive patients who underwent aortic valve replacement surgery and who received concomitant bypass surgery between 2001–2010 had higher 5-year mortality than their counterparts without CABG. Prior CABG, renal function, age but not concomitant CABG remained independently associated with increased mortality. Finally, the observed mortality rate in this consecutive patient group compared favourably with preoperative risk assessment using the EuroSCORE.     

Report on outcomes of valve-in-valve transcatheter aortic valve implantation and redo surgical aortic valve replacement in the Netherlands

Netherlands Heart Journal - We sought to investigate real-world outcomes of patients with degenerated biological aortic valve prostheses who had undergone valve-in-valve transcatheter aortic valve...     

Supra-annular Valve-in-Valve implantation reduces blood stasis on the transcatheter aortic valve leaflets

Leaflet thrombosis following transcatheter aortic valve replacement (TAVR) and Valve-in-Valve (ViV) procedures has been increasingly recognized. This study aimed to investigate the effect of positioning of the transcatheter aortic valve (TAV) in ViV setting on the flow dynamics aspect of post-ViV thrombosis by quantifying the blood stasis in the intra-annular and supra-annular settings. To that end, two idealized computational models, representing ViV intra-annular and supra-annular positioning of a TAV were developed in a patient-specific geometry. Three-dimensional flow fields were then obtained via fluid-solid interaction modeling to study the difference in blood residence time (BRT) on the TAV leaflets in the two settings. At the end of diastole, a strip of high BRT ($⩾1.2s$) region was observed on the TAV leaflets in the ViV intra-annular positioning at the fixed boundary where the leaflets are attached to the frame. Such a high BRT region was absent on the TAV leaflets in the supra-annular positioning. The maximum value of BRT on the surface of non-, right, and left coronary leaflets of the TAV in the supra-annular positioning were 53%, 11%, and 27% smaller compared to the intra-annular positioning, respectively. It was concluded that the geometric confinement of TAV by the leaflets of the failed bioprosthetic valve in ViV intra-annular positioning increases the BRT on the leaflets and may act as a permissive factor in valvular thrombosis. The absence of such a geometric confinement in the ViV supra-annular positioning leads to smaller BRT and subsequently less likelihood of leaflet thrombosis.     

Simulation of transcatheter aortic valve implantation: a patient-specific finite element approach

Until recently, heart valve failure has been treated adopting open-heart surgical techniques and cardiopulmonary bypass. However, over the last decade, minimally invasive procedures have been developed to avoid high risks associated with conventional open-chest valve replacement techniques. Such a recent and innovative procedure represents an optimal field for conducting investigations through virtual computer-based simulations: in fact, nowadays, computational engineering is widely used to unravel many problems in the biomedical field of cardiovascular mechanics and specifically, minimally invasive procedures. In this study, we investigate a balloon-expandable valve and we propose a novel simulation strategy to reproduce its implantation using computational tools. Focusing on the Edwards SAPIEN valve in particular, we simulate both stent crimping and deployment through balloon inflation. The developed procedure enabled us to obtain the entire prosthetic device virtually implanted in a patient-specific aortic root created by processing medical images; hence, it allows evaluation of postoperative prosthesis performance depending on different factors (e.g. device size and prosthesis placement site). Notably, prosthesis positioning in two different cases (distal and proximal) has been examined in terms of coaptation area, average stress on valve leaflets as well as impact on the aortic root wall. The coaptation area is significantly affected by the positioning strategy ( ? 24%, moving from the proximal to distal) as well as the stress distribution on both the leaflets (+13.5%, from proximal to distal) and the aortic wall ( ? 22%, from proximal to distal). No remarkable variations of the stress state on the stent struts have been obtained in the two investigated cases.     

Multi-biomarker analysis in patients after transcatheter aortic valve implantation (TAVI)

Abstract

Background: In this study we sought to examine whether transcatheter aortic valve implantation (TAVI) is followed by a change in the plasma levels of novel cardiovascular biomarkers.

Methods: We collected blood samples of 79 patients with severe aortic valve stenosis undergoing TAVI before and at 7 days, 1 month, 3 months and 6 months post TAVI and analyzed the plasma concentrations of GDF-15, H-FABP, fetuin-A, galectin 3, sST2 and suPAR by means of ELISA.

Results: There was a significant increase in the concentration of fetuin-A (median: 52.44 mg/ml to 113.2 mg/ml, p?<?0.001) and a significant decrease of H–FABP after TAVI (median: 4.835 ng/ml to 2.534 ng/ml, p?<?0.001). The concentrations of suPAR and sST2 showed an initial increase (suPAR median: 2755 pg/ml 3489 pg/ml, p?<?0.001; sST2 median: 5832 pg/ml to 7137 pq/ml, p?<?0.001) and subsequently decreased significantly.

Conclusion: We hypothesize that the decrease of H-FABP and the increase of fetuin-A could be due to a hemodynamic improvement after valve replacement. The initial increase of suPAR could indicate an inflammatory stimulus and the significant increase in sST2 could be due to the mechanical strain caused by implantation of the valve.     

A case study on implantation strategies to mitigate coronary obstruction in a patient receiving transcatheter aortic valve replacement

Coronary obstruction is a life threatening complication during and post-transcatheter aortic valve replacement (TAVR). The objective of this preliminary work is to investigate the mechanisms underlying coronary obstruction in a patient after TAVR, in whom coronary obstruction was confirmed in addition to highlighting the importance of pre-procedural planning. The aortic root of an 80-year old male patient with coronary obstruction during TAVR–where a 29 mm SAPIEN 3 was deployed-was segmented from Computed Tomography scans and 3D-printed with compliant material. Flow and pressure data were acquired in this 3D-printed model in-vitro using a pulse duplicator under physiological conditions for the cases: a 29 mm SAPIEN 3, a 26 mm SAPIEN 3 expanded with a 29 mm balloon, and a 31 mm Medtronic-CoreValve deployed annularly, supra and sub-annularly respectively. Only the CoreValve in sub-annular axial position and the 29 mm SAPIEN 3 yielded pressure gradients (PG) lower than 10 mmHg (6.76 ± 0.52 and 5.72 ± 0.13 mmHg respectively) while the 26 mm SAPIEN 3, CoreValve in normal and supra-annular positions yielded higher PGs (15.5 ± 0.48, 12.2 ± 0.15 and 10.8 ± 0.24 mmHg respectively). 29 mm SAPIEN 3 implantation yielded an FFR value of 45.7 ± 0.6%. However, 31 mm CoreValve in any of the three different annular positions yielded FFR values going from 89.6 ± 1.1% in supra-annular position to 98.3 ± 1.1% in sub-annular position. Implantation with a 26 mm SAPIEN 3 expanded with a 29 mm balloon also yielded an FFR of 92.1 ± 1.2%. Coronary obstruction in this patient could have been prevented through usage of different valve types and/or through usage of a different combination of valve size-balloon sizes.     

"Ring pledget": a new concept for secure apex closure during transapical aortic valve implantation

Transapical aortic valve implantation requires puncture of the left ventricle apex and insertion of a 32-French delivery sheath. A critical step in the procedure consists of secure closure of the ventricular apex. We describe 2 cases of apical rupture of 42 transapical aortic valve implantations. Furthermore, we describe the use of a newly designed single circular Teflon pledget that can help to avoid this complication. This pledget provides a more secure and uniform shrinkage of the entire apex to close the defect left by the delivery sheath.     

The rationale of using cerebral embolic protection devices during transcatheter aortic valve implantation

Aortic valve stenosis is one of the most common valvular abnormalities, which can manifest as angina, syncope, dyspnoea and sudden cardiac death. Transcath     

Infective complications after transcatheter aortic valve implantation: results from a single centre

After its first introduction in 2002, transcatheter aortic valve implantation (TAVI) has continuously gained more foothold for the treatment of severe aortic stenosis and is nowadays a viable treatment option for inoperable patients or patients at high risk for conventional surgical aortic valve replacement. Although ideally carried out in a so-called hybrid room, incorporating both the strict hygiene and advanced life support possibilities of the operating theatre and the imaging and percutaneous arsenal of the catheterisation suite, in most centres TAVI is at present performed in the catheterisation laboratory. This may raise concern about an increased risk of infection, since there the criteria that are applied regarding disinfection and sterilisation are not as stringent as those of the operating theatre. Therefore, we retrospectively assessed the number of infective complications in patients undergoing TAVI in the catheterisation lab of our institution. Eleven out of 73 patients developed a postprocedural infection, one of which could be attributed to the procedure itself, being superinfection of a surgical groin cut-down. Our conclusion is that percutaneous aortic valve implantation in a catheterisation laboratory is not associated with an increased risk of infective complications.     

Transcatheter aortic valve implantation

There has been significant improvement in device designs, operative techniques, and early clinical outcomes in <5 years. Presently, there are two catheter-based bioprostheses (balloon expandable or self-expandable), which have been widely used in humans and are undergoing clinical investigations. Three approaches, including transvenous, transarterial, and transapical have been used for delivery of the catheter-based bioprostheses, and transarterial and transapical approaches have been adopted by cardiologists and cardiac surgeons worldwide. The most recent clinical results have been very encouraging and promising. With experience, 30-day operative mortality with either balloon-expandable or self-expandable bioprosthesis was reduced significantly to approximately 10% in high-risk patients. In vivo long-term durability of catheter-based bioprostheses remains unknown, and presently transcatheter procedure is limited to the cohort of high-risk patients. Expanding this new technology to low-risk patients should be done with extreme caution because conventional aortic valve replacement still provides the best long-term outcome with minimal operative mortality and morbidity in low-risk patients. Ongoing clinical trials will address many unanswered questions, such as patient selection, long-term in vivo durability, preoperative assessment, and the role of the procedures in management of valvular diseases.     

Determinants of elevated carbohydrate antigen 125 in patients with severe symptomatic aortic valve stenosis referred for transcatheter aortic valve implantation

Purpose: Elevated carbohydrate antigen 125 (CA125) predicts adverse outcome after transcatheter aortic valve implantation (TAVI). While known underlying pathophysiological mechanisms of elevated CA125 include serosal effusions and inflammatory stimuli, clinical determinants associated with elevated CA125 in patients referred for TAVI remain unknown. Therefore, we investigated clinical, laboratory and echocardiographic determinants of elevated CA125 in patients with severe aortic valve stenosis referred for TAVI.

Methods: This study includes 650 patients with severe aortic stenosis referred for TAVI. Baseline CA125 was determined by an immunoassay and dichotomized (elevated versus normal) based on the manufacturer cutoff value (>35?U/mL).

Results: CA125 elevation was present in 28% (181/650). Patients with elevated CA125 had an overall worse clinical profile and were more symptomatic with a higher rate of NYHA class III/IV (80% versus 58%; p?Conclusion: Elevated CA125 levels in patients referred for TAVI summarize a subset of patients with an overall worse clinical profile who are more symptomatic.