Joint consensus statement and guideline on transcatheter aortic valve implantation (TAVI) in South Africa - October 2016

The South African Heart Association (SA Heart), together with 2 of its special interest groups, South African Society of Cardiovascular Intervention (SASCI) and Society of Cardiothoracic Surgeons of South Africa (SCTSSA) represent the scientific, educational, socio-economic, ethical and professional interests of South African cardiac specialists, with a combined membership of over 200 members

The South African SHARE-TAVI registry: incidence and risk factors leading to conduction disturbances requiring permanent pacemaker implantation

Background: One of the most common complications post transcatheter aortic valve implantation (TAVI) is the development of heart block requiring permanent pacemaker implantation (PPM). The incidence of PPM in international registries ranges from 13% - 17.5%. Methods: The aim of this observational study was to report the PPM rate in the SHARE-TAVI registry and determine the clinical, electrocardiographic and procedural predictors of PPM as well as the effect of PPM on clinical outcomes. Results: Three hundred and fi ve subjects were analysed. The PPM rate was 9%. Third degree atrioventricular block at the time of implant was the most common indication for PPM. Self-expanding valves (PPM rate 14% vs. 6% for balloon-expandable valves, p=0.02) were correlated with the need for PPM. Baseline ECG predictors of PPM were axis deviation, QRS duration and conduction delay, most notably a pre-existing right bundle branch block (OR 15.88, p<0.01). PPM infl uenced functional class at 30 days, but not the need for repeat hospitalisation or mortality at 30-day and 1-year follow-up. Conclusions: A PPM rate lower than that reported in large international registries was found. Predictors of PPM and the infl uence of PPM on outcomes were similar to those reported in the international data

Transcatheter aortic valve implantation using anatomically oriented, marrow stromal cell-based, stented, tissue-engineered heart valves: technical considerations and implications for translational cell-based heart valve concepts

OBJECTIVES While transcatheter aortic valve implantation (TAVI) has rapidly evolved for the treatment of aortic valve disease, the currently used bioprostheses are prone to continuous calcific degeneration. Thus, autologous, cell-based, living, tissue-engineered heart valves (TEHVs) with regeneration potential have been suggested to overcome these limitations. We investigate the technical feasibility of combining the concept of TEHV with transapical implantation technology using a state-of-the-art transcatheter delivery system facilitating the exact anatomical position in the systemic circulation. METHODS Trileaflet TEHVs fabricated from biodegradable synthetic scaffolds were sewn onto self-expanding Nitinol stents seeded with autologous marrow stromal cells, crimped and transapically delivered into the orthotopic aortic valve position of adult sheep (n = 4) using the JenaValve transapical TAVI System (JenaValve, Munich, Germany). Delivery, positioning and functionality were assessed by angiography and echocardiography before the TEHV underwent post-mortem gross examination. For three-dimensional reconstruction of the stent position of the anatomically oriented system, a computed tomography analysis was performed post-mortem. RESULTS Anatomically oriented, transapical delivery of marrow stromal cell-based TEHV into the orthotopic aortic valve position was successful in all animals (n = 4), with a duration from cell harvest to TEHV implantation of 101 ± 6 min. Fluoroscopy and echocardiography displayed sufficient positioning, thereby entirely excluding the native leaflets. There were no signs of coronary obstruction. All TEHV tolerated the loading pressure of the systemic circulation and no acute ruptures occurred. Animals displayed intact and mobile leaflets with an adequate functionality. The mean transvalvular gradient was 7.8 ± 0.9 mmHg, and the mean effective orifice area was 1.73 ± 0.02 cm². Paravalvular leakage was present in two animals, and central aortic regurgitation due to a single-leaflet prolapse was detected in two, which was primarily related to the leaflet design. No stent dislocation, migration or affection of the mitral valve was observed. CONCLUSIONS For the first time, we demonstrate the technical feasibility of a transapical TEHV delivery into the aortic valve position using a commercially available and clinically applied transapical implantation system that allows for exact anatomical positioning. Our data indicate that the combination of TEHV and a state-of-the-art transapical delivery system is feasible, representing an important step towards translational, transcatheter-based TEHV concept

Injectable living marrow stromal cell-based autologous tissue engineered heart valves: first experiences with a one-step intervention in primates

Aims A living heart valve with regeneration capacity based on autologous cells and minimally invasive implantation technology would represent a substantial improvement upon contemporary heart valve prostheses. This study investigates the feasibility of injectable, marrow stromal cell-based, autologous, living tissue engineered heart valves (TEHV) generated and implanted in a one-step intervention in non-human primates. Methods and results Trileaflet heart valves were fabricated from non-woven biodegradable synthetic composite scaffolds and integrated into self-expanding nitinol stents. During the same intervention autologous bone marrow-derived mononuclear cells were harvested, seeded onto the scaffold matrix, and implanted transapically as pulmonary valve replacements into non-human primates (n = 6). The transapical implantations were successful in all animals and the overall procedure time from cell harvest to TEHV implantation was 118 ± 17 min. In vivo functionality assessed by echocardiography revealed preserved valvular structures and adequate functionality up to 4 weeks post implantation. Substantial cellular remodelling and in-growth into the scaffold materials resulted in layered, endothelialized tissues as visualized by histology and immunohistochemistry. Biomechanical analysis showed non-linear stress-strain curves of the leaflets, indicating replacement of the initial biodegradable matrix by living tissue. Conclusion Here, we provide a novel concept demonstrating that heart valve tissue engineering based on a minimally invasive technique for both cell harvest and valve delivery as a one-step intervention is feasible in non-human primates. This innovative approach may overcome the limitations of contemporary surgical and interventional bioprosthetic heart valve prosthese

Global unmet needs in cardiac surgery

More than 6 billion people live outside industrialized countries and have insufficient access to cardiac surgery. Given the recently confirmed high prevailing mortality for rheumatic heart disease in many of these countries together with increasing numbers of patients needing interventions for lifestyle diseases due to an accelerating epidemiological transition, a significant need for cardiac surgery could be assumed. Yet, need estimates were largely based on extrapolated screening studies while true service levels remained unknown. A multi-author effort representing 16 high-, middle-, and low-income countries was undertaken to narrow the need assessment for cardiac surgery including rheumatic and lifestyle cardiac diseases as well as congenital heart disease on the basis of existing data deduction. Actual levels of cardiac surgery were determined in each of these countries on the basis of questionnaires, national databases, or annual reports of national societies. Need estimates range from 200 operations per million in low-income countries that are nonendemic for rheumatic heart disease to >1,000 operations per million in high-income countries representing the end of the epidemiological transition. Actually provided levels of cardiac surgery range from 0.5 per million in the assessed low- and lower-middle income countries (average 107 ± 113 per million; representing a population of 1.6 billion) to 500 in the upper-middle-income countries (average 270 ± 163 per million representing a population of 1.9 billion). By combining need estimates with the assessment of de facto provided levels of cardiac surgery, it emerged that a significant degree of underdelivery of often lifesaving open heart surgery does not only prevail in low-income countries but is also disturbingly high in middle-income countries

Minimally invasive and transcatheter techniques in high-risk cardiac surgery patients

Minimally invasive procedures have become pivotal in cardiac surgery, especially for the ever-increasing group of high-risk patients. These procedures are defined by the surgical access and/or the avoidance of cardiopulmonary bypass. Both of these aspects have been shown to be beneficial for patients with an increased perioperative risk. For high-risk patients with coronary artery disease, off-pump coronary artery bypass surgery via various surgical access routes can be performed. For patients with heart valve disease, minimally invasive approaches are routinely used in the clinic. During the last decade, interventional methods to treat aortic and mitral valve disease including transcatheter aortic valve replacement and the MitraClip were developed. These modalities have provided clinicians with the ability to treat patients with very high operative risk that are considered not fit for conventional surgery

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