TRANSCATHETER AORTIC VALVE REPLACEMENT: FROM IDEA TO IMPLEMENTATION
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Highlights Transcatheter aortic valve replacement is an innovative trend in modern cardiovascular surgery. This minimally invasive image-guided endovascular technology is becoming more and more safe, nowadays it can involve a minimalistic approach in which the aortic valve replacement is performed without incisions, anesthesia and cardiopulmonary bypass - patients are conscious and spontaneously breathing. The article describes a paradigm shift in modern cardiology, in which the concept of treating patients with degenerative aortic valve stenosis has changed over the 20 years of existence of the transcatheter replacement, starting as a method used only in small number of extremely high-risk patients unsuitable for cardiac surgery and now being the most prevalent treatment modality in patients at intermediate and even low surgical risk. The main clinical and technical principles of transcatheter aortic valve replacement, as well as the prospects for the development of this technique, are highlighted. Abstract Transcatheter aortic valve replacement technique was first implemented about 20 years ago, in April 2002. A quarter of a century ago, specialists involved in image-guided surgery would have never believed that they would perform transcatheter interventions on heart valves. Transcatheter interventions are an alternative to open-heart surgery for acquired heart disease. Transcatheter heart valve replacement or repeat transcatheter aortic valve replacement, which do not require incisions, cardiopulmonary bypass, and in some cases general anesthesia, to this day continue to be perceived as revolutionary and breakthrough, saving the lives of many patients. The article presents the main milestones in the development of image-guided endovascular surgery and transcatheter aortic valve replacement technique, the number of which in the United States and several European countries increases by 10–15% annually, reaching hundreds of thousands per year. The etiology and pathophysiology of aortic stenosis, the technique of transcatheter aortic valve replacement and the outcome of this promising minimally invasive procedure are presented.Keywords:
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Surgical aortic valve replacement (SAVR) is the current treatment of choice for good surgical candidates with moderate to severe symptomatic aortic stenosis (AS). As transcatheter aortic valvular replacement (TAVR) has shown an improved one and two-year all-cause mortality, it has been chosen for moderately symptomatic severe AS patients. The purpose of this review was to perform a clinical comparison of TAVR vs. SAVR and to analyze the Health Index Factor (HIF) that makes TAVR a treatment of choice in asymptomatic AS patients. An extensive literature search of PubMed, Cochrane, and Embase databases was performed using the keywords “Aortic stenosis”, “SAVR”, “TAVR”, and “Asymptomatic”. A total of 45 prospective randomized clinical trials in the English language that were published from the year 2000 onwards were included in the final analysis. It has been found that 59.3% of asymptomatic AS patients are likely to die in the next five years without proactive treatment. Multiple studies have proven that early intervention with aortic valve replacement is superior to conservative treatment in severe asymptomatic AS; however, the choice between SAVR and TAVR is not well established. The NOTION Trial, SURTAVI Trail, and PARTNER 3 study have shown the non-inferiority of TAVR over SAVR, during one-year follow-up for low surgical risk patients. Evolut Low-Risk study and Early TAVR are the only two prospective studies performed to date that have enrolled patients with asymptomatic severe AS. The Evolut Trial demonstrated no difference in all-cause mortality at 30 days (1.3% vs. 4.8%. p=0.23), and 12 days (1.3% vs. 6.5%, p=0.11). Additionally, TAVR also decreases the risk of post-procedural atrial fibrillation, acute kidney injury (AKI), and rehospitalization, and leads to significant improvement in the mean trans-aortic pressure gradient. TAVR also showed marked improvement in the 30-day Quality of Life (QOL) index, where SAVR did not report any significant change in the QOL index. However, the official recommendations of Early TAVR are still awaited. TAVR has consistently shown a statistically non-significant difference in case mortality, risk of stroke, and rehospitalization with moderate to high surgical risk patients whereby recent initial trials have shown significant improvement in the QOL index and hemodynamic index for patients with asymptomatic disease. More extensive studies are required to prove the risk stratifications, long-term outcomes, and clinical characteristics that would make TAVR a preferred intervention in asymptomatic patients.
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Background The hemodynamics of most prosthetic valves are often inferior to that of the normal native valve, and a significant proportion of patients undergoing surgical (SAVR) or transcatheter aortic valve replacement (TAVR) have high residual transaortic pressure gradients due to prosthesis–patient mismatch (PPM). As the experience with TAVR has increased and long-term outcomes are reported, a close look at the PPM literature is required in light of new evidence. Methods For this review, we searched the Embase, Medline, and Cochrane databases from 2000 to 2022. Articles reporting PPM as an outcome following aortic valve replacements were identified and reviewed. Results The impact of PPM on clinical outcomes in aortic valve replacement has not been clear as multiple studies failed to report PPM incidence. However, the PPM outcomes after SAVR vary more widely than after TAVR, ranging from 8% to 80% in SAVR and from 24% to 35% in TAVR. Incidence of severe PPM following redo SAVR ranges from 2% to 9% and following valve-in-valve TAVR is from 14% to 33%, however, while PPM is higher in valve-in-valve TAVR, patients had better survival rates. Conclusions The gap between valve performance and clinical outcomes in SAVR and TAVR could be reduced by carefully selecting patients for either treatment option. Understanding predictors of PPM can add to the safety, effectiveness, and increased survival benefit of both SAVR and TAVR.
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Background: The hemodynamics of most prosthetic valves are often inferior to that of the normal native valve, and a significant proportion of patients undergoing surgical (SAVR) or transcatheter aortic valve replacement (TAVR) have high residual transaortic pressure gradients due to prosthesis–patient mismatch (PPM). Since the experience with TAVR has increased and long-term outcomes are reported, a close look at the PPM literature is required in light of new evidence. Methods: For this review, we searched the Embase, Medline, and Cochrane databases from 2000 to 2022. Articles reporting PPM as an outcome following aortic valve replacements were identified and reviewed. Results: The impact of PPM on clinical outcomes aortic valve replacement has not been clear since multiple studies failed to report PPM incidence. However, the PPM after SAVR vary greater than after TAVR, ranging from 8% to almost 80% in SAVR and from 24%-35% in TAVR. Incidence of severe PPM following redo SAVR is ranging from 2 to 9% and following valve-in-valve TAVR is from 14 to 33%, however, while PPM is higher in valve-in-valve TAVR, patients had better survival rates. Conclusions: The gap between valve performance and clinical outcomes in TAVR and SAVR could be reduced by carefully selecting patients for either treatment option. Understanding predictors of PPM can add to the safety, effectiveness, and increased survival benefit of both TAVR and SAVR.
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The hemodynamics and outcomes in patients with a small aortic annulus (SAA) after transcatheter aortic valve replacement (TAVR) with a second-generation transcatheter heart valve remain unclear. We investigated whether TAVR with a Sapien XT (Edwards Lifesciences, Irvine, California) influences postprocedural valve hemodynamics and long-term outcome in high-risk SAA patients compared with surgical aortic valve replacement (SAVR).We retrospectively identified 94 SAA patients who underwent aortic valve replacement (TAVR = 35 and SAVR = 59). SAA was defined as an aortic annulus diameter ≤ 20 mm, measured by preprocedural transesophageal echocardiography.The mean age was 80.2 years. The mean Society of Thoracic Surgeons-Predicted Risk of Mortality was 6.8%. The post-procedural peak transvalvular velocity and mean pressure gradient were significantly lower in the TAVR cohort than in the SAVR cohort, whereas the postprocedural aortic valve area was significantly higher in the TAVR cohort. Severe prosthesis-patient mismatch (PPM) occurred less frequently after TAVR than SAVR (TAVR 2.9% versus SAVR 22.0%, P = 0.01). The two-year mortality in SAA patients was similar between the two groups.TAVR with a Sapien XT in SAA patients improved the valve hemodynamics and reduced the incidence of PPM compared with SAVR. TAVR patients had a similar 2-year mortality despite higher risk baseline characteristics. To avoid PPM and the consequent poor outcomes, TAVR can be considered an alternative option to SAVR in high surgical risk patients with SAA.
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