Transcatheter Aortic Valve Replacement in Large Annuli Valves With the Supra-Annular, Self-Expandable Evolut Platform in a Real-World Registry.

BACKGROUND: Transcatheter aortic valve replacement is approved for treatment of patients with severe aortic stenosis across the spectrum of risk. While considering broader indications for use, transcatheter aortic valve replacement in large native annuli has become increasingly important. METHODS: Patients with tricuspid aortic stenosis undergoing transcatheter aortic valve replacement using the Evolut R or Evolut PRO+ 34 mm valves (Medtronic, Minneapolis, MN) in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry between October 2016 and September 2020 were stratified according to in range (>12%) device oversizing and below range (0%-12%) device oversizing. Patients undergoing valve-in-valve procedures, having a baseline annulus size <26 or ≥34 mm, or without computed tomography angiography measured annulus size were excluded. Percentage of oversizing was calculated as [(valve diameter-annulus diameter)×100/annulus diameter]. RESULTS: Transcatheter aortic valve replacement in patients with large annuli was performed in 8017 patients with a mean (±SD) age 79.3±7.9 years and 94% were male. Below range (n=1096) was less common than in range oversizing (n=6921). At 1-year follow-up, mortality (19.6% versus 14.9%; P=0.001), aortic valve reintervention (2.1% versus 0.6%; P<0.001) and valve-related readmission rates (3.2% versus 2.0%; P=0.014) were higher in the below range device oversizing group versus in range group respectively. In a multivariable Cox proportional hazards regression model, when controlling for clinically relevant covariates, below range device oversizing was associated with higher 1-year all-cause mortality (HR, 1.28 [CI, 1.07-1.51]; P=0.005). CONCLUSIONS: Results from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry in patients with large annuli valves using 34mm Evolut R/PRO+ valves suggest that in range (>12%) device oversizing delivered better clinical outcomes than implantation with below range (0%-12%) device oversizing.

Transit-time flow measurement parameters after protamine infusion in CABG surgeries.

OBJECTIVE: The objective of this study is to evaluate protamine sulfate effects on graft's blood flow by comparing transit-time flow measurement (TTFM) values before and after protamine administration. METHODS: This is an observational study with data collected between years 2018 and 2020. Immediate graft patency was evaluated using TTFM. Only patients with TTFM parameters registered before and after protamine infusion were included. The main three parameters studied were:  mean graft flow  (MGF),  pulsatility index (PI), and  diastolic flow (DF). In the first analysis, all conduits were evaluated regardless of the surgical technique used. In a second analysis, on-pump and off-pump groups were compared. Evaluated grafts were left internal thoracic artery, saphenous vein graft (SVG), radial artery, and right internal thoracic artery. Since SVG was numerically the most used graft, an exclusive analysis was created. RESULTS: Our study included 575 patients, resulting in a total of 1686 grafts, mean 2.93 grafts/patient. Off-pump surgery was performed in 158 patients. Before protamine infusion, inadequate TTFM parameters were observed in 3.8% of grafts. Overall, after protamine administration, MGF decreased in all grafts, but its reduction was not statistically significant. PI values increased in the SVG and DF values reduced in LIMA grafts. SVG group analysis showed that after protamine PI values were higher in OM1 and RCA. DF values increased in RCA. The comparison between off and on-pump surgeries, showed that in off-pump cases TTFM measures did not present statistically significant differences. CONCLUSION: Significant variations were observed in TTFM values before and after protamine administration. Although different, those values remained within the normal reference ranges. We recommend that flow measurement should be performed before protamine infusion.

Redo-transcatheter aortic valve replacement with the supra-annular, self-expandable Evolut platform: Insights from the Transcatheter valve Therapy Registry.

OBJECTIVES: To assess the safety profile of redo-TAVR procedures from patients in the transcatheter valve therapy (TVT) Registry. BACKGROUND: The use of transcatheter aortic valves (TAV) to treat previously implanted failing TAVS (TAV-in-TAV) has been an increasingly important topic as indications for TAVR move to younger and lower-risk patients, but data on the safety and efficacy of redo-TAVR is limited. METHODS: Patients undergoing redo-TAVR procedures using the Evolut R, Evolut PRO or Evolut PRO+ valve in the TVT Registry between April 2015 and March 2020 were included. In-hospital, 30-day and 1-year outcomes were analyzed. RESULTS: Redo-TAVR was performed in 292 patients (213 patients received the Evolut R valve and 79 received the Evolut PRO or PRO+ valve). Device success was achieved in 94.5%. In-hospital mortality was 2.1%, stroke occurred in 2.7%, and 77.2% of patients were discharged home. There were no cases of coronary compression/obstruction or myocardial infarction that occurred in index hospitalization. Mean gradient at 30-days was 11.9 ± 6.9 mmHg, and 73.1% had none/trace total aortic regurgitation. CONCLUSIONS: Results from the TVT Registry demonstrate good short-term outcomes after redo-TAVR with the supra-annular, self-expandable Evolut platform. Long-term follow-up is necessary to further expand understanding this complex scenario.

Transcatheter Aortic Valve Replacement With Self-Expandable Supra-Annular Valves for Degenerated Surgical Bioprostheses: Insights From Transcatheter Valve Therapy Registry.

Background Transcatheter aortic valve replacement with supra-annular transcatheter heart valves has been adopted in patients with degenerated surgical aortic valves. The next generation self-expanding Evolut PRO valve has not been evaluated in patients with surgical valve failure. Methods and Results Patients undergoing transcatheter aortic valve replacement in degenerated surgical aortic valve procedures using the Evolut R or Evolut PRO transcatheter heart valves in the Society of Thoracic Surgeons and American College of Cardiology Transcatheter Valve Therapy Registry between April 2015 and June 2019 were evaluated. Transcatheter valve performance was evaluated by clinical site echocardiography. In-hospital, 30-day, and 1-year clinical outcomes were based on the Society of Thoracic Surgeons-American College of Cardiology-Transcatheter Valve Therapy registry definitions. Transcatheter aortic valve replacement in degenerated surgical aortic valve was performed in 5897 patients (5061 [85.8%] patients received the Evolut R valve and 836 [14.2%] received the Evolut PRO valve). Thirty-day transcatheter heart valves hemodynamic performance was excellent in both groups (mean gradient: Evolut PRO: 13.8±7.5 mm Hg; Evolut R: 14.5±8.1 mm Hg), while paravalvular regurgitation was significantly different between valve types (P=0.02). Clinical events were low at 30 days (Evolut PRO: for the all-cause mortality, 2.8%, any stroke was 1.8%, new pacemaker implantation, 3.0%: Evolut R:all-cause mortality, 2.5%, any stroke was 2.2%, new pacemaker implantation, 5.3%) and 1 year (Evolut PRO: all-cause mortality, 9.2%; any stroke, 3.1%; Evolut R: all-cause mortality, 9.8%; any stroke, 2.9%). Conclusions Transcatheter aortic valve replacement in degenerated surgical aortic valve with self-expandable supra-annular transcatheter heart valves is associated with excellent clinical outcomes and valve hemodynamics. Additional reductions in residual paravalvular regurgitation were obtained with the next generation Evolut PRO.

Treatment of In-Stent Restenosis Using Excimer Laser Coronary Atherectomy and Bioresorbable Vascular Scaffold Guided by Optical Coherence Tomography.

The rate of in-stent restenosis (ISR) has become increasingly prevalent with the exponential growth in stent implantation due to an aging population and a higher life expectancy, in addition to the high rates of obesity and diabetes. In this prospective, single operator, all-comer study, we sought to analyze the performance of ELCA followed by bioresorbable vascular scaffold (BVS) placement in patients undergoing percutaneous coronary intervention (PCI) for ISR. A total of 13 patients had ISR treated with a combination of ELCA and BVS, with 9 patients having matched OCT pre, post ELCA and post BVS. Mean age was 65 ± 11.22 and 83% of the patients were male. Hypertension and dyslipidemia were present in 100% of the patients and smoking and diabetes in 50%. After the procedure, we did not detect residual stenosis over 10% in any patient, resulting in a technical success of 100%. No patients had MACE during their hospital stay or within the next six months, resulting in a procedure success of 100%. The mean lumen area increased 0.35 mm2 from pre procedure to post ELCA and 3.58 mm2 from post ELCA to post BVS. The final difference, from pre procedure to post BVS, was a 3.93 mm2 lumen area gain. The mean lumen diameter increased 0.11 mm from baseline to ELCA, 0.95 mm from post laser to BVS implantation and 1.06 mm from pre procedure to post BVS. The NIH area reduced 0.48 mm2 from pre to post ELCA, 1.13mm2 from post ELCA to BVS implantation and 1.61 mm2 from baseline to post BVS implantation. We conclude that ELCA is a safe and feasible debulking method to approach ISR, with high rates of post-procedural BVS success, within six months follow-up.

Impact of Repositioning on Outcomes Following Transcatheter Aortic Valve Replacement With a Self-Expandable Valve.

OBJECTIVES: This study sought to compare outcomes following transcatheter aortic valve replacement when valve repositioning was performed (repositioned group) versus procedures without repositioning (nonrepositioned group). BACKGROUND: The Evolut R and Evolut PRO valves were designed to allow repositioning during deployment, yet the effect of repositioning on clinical outcomes remains unclear. METHODS: Patients implanted with the Evolut R or PRO valve from the SURTAVI (Surgical Replacement and Transcatheter Aortic Valve Implantation) trial continued access study and the Evolut Low Risk Trial between June 2016 and November 2018 were combined. Baseline multidetector computed tomography data were analyzed for the Evolut Low Risk Trial patients. The primary outcomes were the rate of all-cause mortality and the rate of disabling stroke 30 days. Secondary outcomes were per Valve Academic Research Consortium-2. RESULTS: The Evolut R or PRO valve was implanted in 946 patients, and repositioning was performed in 318 (33.6%). Compared with patients in the nonrepositioned group, patients in the repositioned group had lower Society of Thoracic Surgeons score (2.3 ± 1.3% vs. 2.6 ± 1.4%; p < 0.001) and fewer prior percutaneous coronary interventions (11.9% vs. 19.7%; p = 0.003). There were no differences in baseline multidetector computed tomography parameters between groups. There were no differences in the primary outcome of death (0.3% vs. 0.3%; p = 0.99) or disabling stroke (0.3% vs. 0.5%; p = 0.71) at 30 days or 1 year (1.9% vs. 2.9%; p = 0.44; and 0.8% vs. 0.9%%; p = 0.79, respectively). CONCLUSIONS: The utilization of the repositioning feature of the Evolut valves was safe, and no differences in death or disabling stroke were observed at 30 days or 1 year between groups. (Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients; NCT02701283; Safety and Efficacy Study of the Medtronic CoreValve® System In the Treatment of Severe, Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement [SURTAVI]; NCT01586910).

Geometric reconstruction of a left ventricular aneurysm with coronary artery bypass graft.

Left ventricular aneurysm is a late mechanical complication of untreated acute myocardial infarction. It has become relatively rare since the development of percutaneous cardiac intervention.  Most aneurysms are located at the anterior ventricular wall, and are caused by total occlusion of the left anterior descending artery. Usually, the anterior and apical walls initially become akinetic; this can sometimes evolve into dyskinesia. Thrombus formation is a common finding, since the apical contractility is impaired. This tutorial illustrates the challenging technical aspects of a large thrombus removal, along with the geometric reconstruction of the left ventricular aneurysm and coronary bypass surgery.

Degradation modeling of poly-l-lactide acid (PLLA) bioresorbable vascular scaffold within a coronary artery.

In this work, a strain-based degradation model was implemented and validated to better understand the dynamic interactions between the bioresorbable vascular scaffold (BVS) and the artery during the degradation process. Integrating the strain-modulated degradation equation into commercial finite element codes allows a better control and visualization of local mechanical parameters. Both strut thinning and discontinuity of the stent struts within an artery were captured and visualized. The predicted results in terms of mass loss and fracture locations were validated by the documented experimental observations. In addition, results suggested that the heterogeneous degradation of the stent depends on its strain distribution following deployment. Degradation is faster at the locations with higher strains and resulted in the strut thinning and discontinuity, which contributes to the continuous mass loss, and the reduced contact force between the BVS and artery. A nonlinear relationship between the maximum principal strain of the stent and the fracture time was obtained, which could be transformed to predict the degradation process of the BVS in different mechanical environments. The developed computational model provided more insights into the degradation process, which could complement the discrete experimental data for improving the design and clinical management of the BVS.

Seguimento clínico a médio prazo com uso exclusivo de enxertos arteriais na revascularização completa do miocárdio em pacientes com doença coronária triarterial / Midterm follow-up with exclusive use of arterial grafts in complete myocardial revascularization of patients with triple vessel coronary artery disease

OBJETIVO: Avaliar os benefícios a médio prazo do uso exclusivo de enxertos arteriais em pacientes com doença aterosclerótica coronária triarterial submetidos à revascularização completa do miocárdio. MÉTODO: Entre julho/95 e julho/97, 137 pacientes consecutivos foram submetidos à revascularização miocárdica com uso exclusivo de enxertos arteriais. Destes, 112 (81,7 por cento) eram do sexo masculino e a idade variou de 36 a 78 anos (média de 56,5 anos). Foram utilizados 363 enxertos arteriais, sendo realizadas 442 anastomoses coronárias; média de 3,2 anastomoses coronárias por paciente. Os enxertos arteriais utilizados foram a artéria torácica interna esquerda (99,3 por cento), artéria torácica interna direita (56,2 por cento), artéria radial (94,9 por cento), a artéria gastroepiplóica direita (13,9 por cento) e a artéria epigástrica inferior (0,7 por cento). Em 80 (58,4 por cento) pacientes foram construídos enxertos arteriais compostos, com anastomose em "Y" da artéria torácica interna esquerda com outro enxerto arterial. RESULTADOS: Não houve mortalidade operatória. Ocorreram quatro (2,9 por cento) óbitos durante o período de internação hospitalar e apenas um (0,7 por cento) paciente necessitou ser reoperado no seguimento inicial. A probabilidade livre de eventos cardíacos (infarto do miocárdio, angioplastia, reoperação ou óbito) foi de 87,0 por cento e a sobrevida foi de 94,0 por cento com sete anos de seguimento clínico. CONCLUSÕES: O uso exclusivo de enxertos arteriais na revascularização completa do miocárdio em pacientes com doença aterosclerótica coronária triarterial apresenta bons resultados imediatos e a médio prazo. O acompanhamento desses pacientes a longo prazo nos mostrará a influência do uso exclusivo de enxertos arteriais no tratamento cirúrgico da insuficiência coronária.

Tratamento cirúrgico da rotura de parede livre do ventrículo esquerdo após infarto agudo do miocárdio / Surgical treatment of left ventricular free wall rupture after acute myocardial infarction

CASUÍSTICA E MÉTODOS: Entre janeiro de 1983 e maio de 1999, 12.405 pacientes com diagnóstico de infarto agudo do miocárdio (IAM) foram atendidos no InCor. Destes, 127 (1,02por cento) apresentaram rotura de parede livre do ventrículo esquerdo como complicação do IAM. A rotura miocárdica aguda ocorreu em 98 (77,1por cento) pacientes e a subaguda em 29 (22,9por cento). RESULTADOS: Foram operados 5 pacientes na forma aguda, com 80por cento de mortalidade e 19 na forma subaguda, com 15,8por cento de mortalidade. A sobrevida pós-operatória abrangendo os dois grupos foi de 70,8por cento. CONCLUSÃO: concluímos que a rotura de parede livre do ventrículo esquerdo é uma grave complicação do IAM, necessitando de atuação imediata. Nas formas agudas, observa-se rápida deterioração hemodinâmica do paciente, muitas vezes sem tempo hábil para tentativa de correção cirúrgica. As formas subagudas podem ser detectadas e monitorizadas através de exames ecocardiográficos seriados após o IAM. Nestes casos a intervenção cirúrgica precoce, muitas vezes sem a necessidade de instalação de circulação extracorpórea, tem contribuído para a sobrevida da maioria dos pacientes