Comparing two-year outcomes of balloon-expandable Myval and self-expanding Evolut R in severe aortic valve stenosis.

BACKGROUND: The new balloon-expandable (BE) Myval transcatheter heart valves (THV) has shown promising early results with low paravalvular leak (PVL) and permanent pacemaker implantation (PPI) rates. Limited data are available regarding its long-term performance. We aimed to compare the 2-year clinical and echocardiographic outcomes of transcatheter aortic valve replacement (TAVR) using the self-expanding (SE) Evolut R and the BE Myval THVs. METHODS: The EVAL study included 166 patients with severe aortic valve stenosis who underwent TAVR either with SE Evolut R (n = 108) or BE Myval (n = 58) THV. Primary objectives include comparison on clinical efficacy (freedom from all-cause mortality, stroke, and cardiovascular hospitalization), echocardiographic performance and PPI rates between the two THVs. RESULTS: At 2-year the BE Myval group showed higher clinical efficacy (86% vs. 66%,HR:2.62, 95%CI 2.2-5.1;p = 0.006), with fewer cardiac hospitalizations (3.4% vs. 13.9%,p = 0.03). No significant differences in all-cause mortality, cardiovascular mortality, or stroke rates were observed. The proportion of patients with ≥moderate PVL was significantly lower in the BE Myval compared to the SE Evolut R group (4%vs. 22%,p = 0.008). The mean transvalvular gradient was significantly higher in the SE group compared to the BE group (9.5 ± 4.3 vs. 6.9 ± 2.2 mmHg,p < 0.001), however there was no difference in the percentage of patients with a mean gradient ≥20 mmHg between the two groups. CONCLUSIONS: Both THVs offer similar 2-year clinical outcomes. The BE Myval THV demonstrated advantages with higher clinical efficacy and lower PVL incidence. Longer follow-up and randomized trials are needed to validate these results and assess Myval's sustained performance and durability.

Detachable Aortic Clamp for Minimally Invasive Cardiac Surgery.

Since its first implementation, minimally invasive cardiac surgery has become more and more popular among surgeons. By avoiding a complete opening of the sternum, this surgery is traditionally associated with a faster recovery, less surgical pain and less postoperative bleeding and transfusions. With its growing popularity, the need for specifically designed surgical instrumentation is evident. Since 2008, the detachable-branch Glauber clamp (Cardiovision-Trytech, Tokyo, Japan) has been used to facilitate aortic cross-clamp during minimally invasive cardiac surgery, to optimize the intraoperative visualization field without the need for adjunctive incisions of the thorax. It has been specifically developed for limited single-access minimally invasive valve surgery. The clamp is introduced through the main access incision (mini-sternotomy or mini thoracotomy) by means of a specifically designed delivery system, which is subsequently removed, leaving inside the thorax only the detachable closed branches on the aorta. Since its first implementation, the clamp has been used in numerous patients at several cardiac surgery centers worldwide. Over the years, attempts have been made to improve its ergonomics and enhance its performance. The G2 detachable-branch Glauber clamp (USB Medical, Hatboro, PA, USA) occupies a smaller space inside the thorax, has a simplified gripping mechanism and comes with detachable arms that enhance versatility with up to 10 possible clamp configurations. This article describes the characteristics of detachable-branch aortic clamps and compares them to other aortic cross-clamps that are currently available for minimally invasive cardiac surgery.

Percutaneous treatment of abdominal aortic aneurysm and aortic valve stenosis with 'staged' EVAR and TAVR: a case series.

Symptomatic aortic valve stenosis (AS) and abdominal aortic aneurysm (AAA) are critical clinical conditions, increasingly more prevalent with aging of the population. Calcific aortic stenosis is the most common structural cardiac disease in the elderly population, and medical management of severe aortic stenosis of the elderly population is associated with poor outcomes as compared to surgical treatment. Transcatheter aortic valve replacement (TAVR) is a treatment of choice in inoperable, often elderly, patients with symptomatic severe AS and in intermediate-to-high surgical risk patients. It is not yet clarified the incidence of AAA and its impact on procedural and clinical outcomes among patients undergoing TAVR. It is known that after AS resolution with aortic valve replacement or TAVR there is an increase in blood pressure that increases the risk of dissection or abdominal aortic aneurysm rupture if AAA repair is delayed. The purpose of this report is to describe the anatomical details and technical and procedural considerations when proposing totally endovascular strategies dedicated to the treatment of patients with AS and AAA.

Clinical and hemodynamic outcomes of the Perceval sutureless aortic valve from a real-world registry.

OBJECTIVES: Perceval sutureless valve has been in clinical use for >15 years. The aim of this study is to report the real-word clinical and haemodynamic performance from the SURE-aortic valve replacement international prospective registry in patients who underwent aortic valve replacement with Perceval valve. METHODS: From 2011 to 2021, patients from 55 institutions received a Perceval valve. Postoperative, follow-up, and echocardiographic outcomes were analysed. RESULTS: A total of 1652 patients were included; mean age was 75.3 ± 7.0 years (53.9% female); mean EuroSCORE II was 4.1 ± 6.3. Minimally invasive approach was performed in 45.3% of patients; concomitant procedures were done in 35.9% of cases. Within 30 days, 0.3 and 0.7% valve-related reinterventions were reported. Transient ischaemic attack, disabling and non-disabling strokes were limited (0.4%, 0.4% and 0.7%, respectively). Pacemaker implant was required in 5.7% of patients. Intra-prosthetic regurgitation ≥2 was present in 0.2% of cases, while paravalvular leak ≥2 in only 0.1%. At a maximum follow-up of 8 years, 1.9% of cardiovascular deaths and 0.8% of valve-related reintervention occurred. Among the 10 cases of structural valve deterioration (mean 5.6 ± 1.4 years after implant; range: 2.6-7.3 years), 9 were treated with a transcatheter vale-in-valve implantation and 1 with explant. Mean pressure gradient decreased from 45.8 ± 16.5 mmHg preoperatively to 13.3 ± 5.2 mmHg at discharge and remained stable during follow-up. CONCLUSIONS: This experience represents the largest prospective real-world cohort of patients treated with Perceval showing that Perceval is a safe and effective alternative to conventional surgical aortic valve replacement, providing favourable clinical and haemodynamic results also at mid-term follow-up.

Formal consensus study on surgery to replace the aortic valve in adults aged 18-60 years.

OBJECTIVE: There is uncertainty about surgical procedures for adult patients aged 18-60 years undergoing aortic valve replacement (AVR). Options include conventional AVR (mechanical, mAVR; tissue, tAVR), the pulmonary autograft (Ross) and aortic valve neocuspidisation (Ozaki). Transcatheter treatment may be an option for selected patients. We used formal consensus methodology to make recommendations about the suitability of each procedure. METHODS: A working group, supported by a patient advisory group, developed a list of clinical scenarios across seven domains (anatomy, presentation, cardiac/non-cardiac comorbidities, concurrent treatments, lifestyle, preferences). A consensus group of 12 clinicians rated the appropriateness of each surgical procedure for each scenario on a 9-point Likert scale on two separate occasions (before and after a 1-day meeting). RESULTS: There was a consensus that each procedure was appropriate (A) or inappropriate (I) for all clinical scenarios as follows: mAVR: total 76% (57% A, 19% I); tAVR: total 68% (68% A, 0% I); Ross: total 66% (39% A, 27% I); Ozaki: total 31% (3% A, 28% I). The remainder of percentages to 100% reflects the degree of uncertainty. There was a consensus that transcatheter aortic valve implantation is appropriate for 5 of 68 (7%) of all clinical scenarios (including frailty, prohibitive surgical risk and very limited life span). CONCLUSIONS: Evidence-based expert opinion emerging from a formal consensus process indicates that besides conventional AVR options, there is a high degree of certainty about the suitability of the Ross procedure in patients aged 18-60 years. Future clinical guidelines should include the option of the Ross procedure in aortic prosthetic valve selection.

Fast Approximate Quantification of Endovascular Stent Graft Displacement Forces in the Bovine Aortic Arch Variant.

PURPOSE: Displacement forces (DFs) identify hostile landing zones for stent graft deployment in thoracic endovascular aortic repair (TEVAR). However, their use in TEVAR planning is hampered by the need for time-expensive computational fluid dynamics (CFD). We propose a novel fast-approximate computation of DFs merely exploiting aortic arch anatomy, as derived from the computed tomography (CT) and a measure of central aortic pressure. MATERIALS AND METHODS: We tested the fast-approximate approach against CFD gold-standard in 34 subjects with the "bovine" aortic arch variant. For each dataset, a 3-dimensional (3D) model of the aortic arch lumen was reconstructed from computed tomography angiography and CFD then employed to compute DFs within the aortic proximal landing zones. To quantify fast-approximate DFs, the wall shear stress contribution to the DF was neglected and blood pressure space-distribution was averaged on the entire aortic wall to reliably approximate the patient-specific central blood pressure. Also, DF values were normalized on the corresponding proximal landing zone area to obtain the equivalent surface traction (EST). RESULTS: Fast-approximate approach consistently reflected (r2=0.99, p<0.0001) the DF pattern obtained by CFD, with a -1.1% and 0.7° bias in DFs magnitude and orientation, respectively. The normalized EST progressively increased (p<0.0001) from zone 0 to zone 3 regardless of the type of arch, with proximal landing zone 3 showing significantly greater forces than zone 2 (p<0.0001). Upon DF normalization to the corresponding aortic surface, fast-approximate EST was decoupled in blood pressure and a dimensionless shape vector (S) reflecting aortic arch morphology. S showed a zone-specific pattern of orientation and proved a valid biomechanical blueprint of DF impact on the thoracic aortic wall. CONCLUSION: Requiring only a few seconds and quantifying clinically relevant biomechanical parameters of proximal landing zones for arch TEVAR, our method suits the real preoperative decision-making process. It paves the way toward analyzing large population of patients and hence to define threshold values for a future patient-specific preoperative TEVAR planning.

Sheathless Versus Sheathed Intra-Aortic Balloon Pump Implantation in Patients Undergoing Cardiac Surgery.

The intra-aortic balloon pump (IABP) is the most widely available mechanical support device, but its use has been disputed in recent decades. Although several efforts have been made to reduce the associated complication rate, contemporary data on this matter is lacking. The present study aims to evaluate the differences in vascular complications between the sheathless and the sheathed IABP implantation technique in cardiac surgery patients. A retrospective multi-center cohort, consisting of patients treated in 8 cardiac surgical centers, was evaluated. Patients who underwent cardiac surgery with peri-operative IABP support were included. Primary outcome was a composite end point of vascular complications. Propensity score matching (PSM) was performed, and a multivariable regression model was applied to evaluate predictors of vascular complications. The unmatched cohort consisted of 2,615 patients (sheathless n = 1,414, 54%, sheathed n = 1,201, 46%). A total of 878 patients were matched (n = 439 for both groups). The composite vascular complication end point occurred in 3% of patients in the sheathless group, compared with 8% in the sheathed group (p <0.001). Vascular complications were significantly associated with mortality (odds ratio [OR] 3.86, 95% confidence interval [CI] 2.01 to 7.40, p <0.001). Peripheral arterial disease was associated with vascular complications (OR 3.10, 95% CI 1.46 to 6.55, p = 0.003), whereas the sheathless implantation technique was found to be protective (OR 0.36, 95% CI 0.18 to 0.73, p = 0.005). In conclusion, the present retrospective multi-center analysis demonstrated the sheathless implantation technique to be associated with a significant reduction in vascular complication rate. Future studies should focus on even less invasive implantation techniques using smaller-sized catheters, sheathless implantation, and imaging guiding.

Pacemaker after Sutureless and Rapid-Deployment Prostheses: A Progress Report from the SURD-IR.

OBJECTIVES: The aim of this study was to investigate the need for postoperative permanent pacemaker implantation (PPI) following sutureless and rapid-deployment aortic valve replacement (SuRD-AVR) in the context of a progress report from a large multicenter international registry (SURD-IR). METHODS: We retrospectively analyzed 4,166 patients who underwent SuRD-AVR between 2008 and 2019. The primary outcome was the need for PPI before discharge. The study population was analyzed separately according to the implanted prostheses (Su cohort and RD cohort). Each cohort was divided into two groups based on the operation date: an early group ("EG" = 2008-2016) and a late group ("LG" = 2017-2019). RESULTS: The rate of PPI decreased significantly in the Su cohort over time (EG = 10.8% vs LG = 6.3%, p < 0.001). In the Su cohort, a decrease in age, risk profile, and incidence of bicuspid aortic valve, increased use of anterior right thoracotomy, reduction of cardiopulmonary bypass time and of associated procedures, and more frequent use of smaller prostheses were observed over time. In the RD cohort, the rate of PPI was stable over time (EG = 8.8% vs LG = 9.3%, p = 0.8). In this cohort, a younger age, lower risk profile, and higher incidence of concomitant septal myectomy were observed over time. CONCLUSION: Our analysis showed a significant decrease in the PPI rate in patients who underwent Su-AVR over time. Patient selection as well as surgical improvements and a more accurate sizing could be correlated with this phenomenon. The RD cohort revealed no significant differences either in patient's characteristics or in PPI rate between the two time periods.

Minimally invasive cardiac surgery for complex procedures: extensive septal myectomy and double valve replacement.

In this video tutorial, we demonstrate that minimally invasive cardiac surgery and all its benefits can be applied even to complex, multiple cardiac procedures. We present a 71-year-old patient with severely obstructive hypertrophic cardiomyopathy, moderate mitral regurgitation for systolic anterior motion of the mitral valve, moderate aortic stenosis and regurgitation and atrial fibrillation. We performed a mitroaortic valve replacement, transmitral and transaortic septal myectomy and left atrial appendage closure through a minimally invasive approach (right anterolateral minithoracotomy). After establishing peripheric cardiopulmonary bypass, aortic cross-clamping and a left atrium opening, the anterior mitral leaflet was incised circumferentially at its insertion on the annulus to allow an optimal transmitral myectomy. Subsequently, mitral valve removal was completed, and a bioprosthesis was implanted. After closure of the left atrium, the left atrial appendage was closed using a 40-mm device (Atriclip). The aorta was then opened, the aortic valve was excised and a transaortic septal myectomy was completed. Finally, a sutureless aortic bioprosthesis was implanted. Postoperative transoesophageal and transthoracic surgery demonstrated a residual left ventricular outflow tract gradient of 14 mmHg and the correct performance of both biological prostheses. Minimally invasive heart surgery can be offered even to patients requiring complex and multiple procedures, including septal myectomy. Combining the benefits of the operation with those of a minimally invasive approach may optimize postoperative and long-term surgical outcomes.

Mitral Valve Re-Repair Due to Chordal Pseudo-Elongation Through Repeated Right Anterior Minithoracotomy.

OBJECTIVE: We aim to show the step-by-step surgical technique of mitral valve re-repair by means of a repeated right anterior minithoracotomy in a case of a procedure-related early mitral valve repair failure due to left ventricular positive remodeling and chordal pseudo-elongation. METHODS: The patient was readdressed to our institution for an early severe mitral valve regurgitation, less than a year after performing a right minithoracotomy mitral valve repair (42-mm annular ring implantation, P2 triangular resection, and P2 neochord positioning). The mechanism was attributed to a positive left ventricle remodeling and neochordal pseudo-elongation. Therefore, we decided to perform a mitral valve re-repair in a redo minimally invasive cardiac surgery. We describe in a video-guided step-by-step fashion the surgical procedure, from the reopening of the right anterior minithoracotomy to the surgical strategy chosen to address the re-repair, guided by the mechanism of the previous repair failure. RESULTS: We replaced the previously implanted ring with a smaller one and positioned a new polytetrafluoroethylene 4-0 neochord at the P2 level. The patient was discharged home on the fifth postoperative day after an uneventful hospital stay. Predischarge echocardiogram demonstrated undetectable residual mitral valve regurgitation. At 3-month follow-up, echocardiographic and clinical data were encouraging. At 9-month follow-up, the patient endorsed no recurrence of cardiologic symptoms. CONCLUSIONS: Redo minimally invasive cardiac surgery is a viable option even in case of a mitral valve re-repair due to previous repair failure, especially when procedure related in degenerative mitral disease. Combining the benefits of mitral valve re-repair with those of a minimally invasive surgery may optimize short-term and long-term outcomes.

Contemporary outcomes of cardiac surgery patients supported by the intra-aortic balloon pump.

OBJECTIVES: Although the intra-aortic balloon pump (IABP) has been the most widely adopted temporary mechanical support device in cardiac surgical patients, its use has declined. The current study aimed to evaluate the occurrence and predictors of early mortality and complication rates in contemporary cardiac surgery patients supported by an IABP. METHODS: A multicentre, retrospective analysis was performed of all consecutive cardiac surgical patients receiving perioperative balloon pump support in 8 centres between January 2010 to December 2019. The primary outcome was early mortality, and secondary outcomes were balloon-associated complications. A multivariable binary logistic regression model was applied to evaluate predictors of the primary outcome. RESULTS: The study cohort consisted of 2615 consecutive patients. The median age was 68 years [25th percentile 61, 75th percentile 75 years], with the majority being male (76.9%), and a mean calculated 30-day mortality risk of 10.0%. Early mortality was 12.7% (n = 333), due to cardiac causes (n = 266), neurological causes (=22), balloon-related causes (n = 5) and other causes (n = 40). A composite end point of all vascular complications occurred in 7.2% of patients, and leg ischaemia was observed in 1.3% of patients. The most important predictors of early mortality were peripheral vascular disease [odds ratio (OR) 1.63], postoperative dialysis requirement (OR 10.40) and vascular complications (OR 2.57). CONCLUSIONS: The use of the perioperative IABP proved to be safe and demonstrated relatively low complication rates, particularly for leg ischaemia. As such, we believe that specialists should not be held back to use this widely available treatment in high-risk cardiac surgical patients when indicated.

A Deep Learning-Based and Fully Automated Pipeline for Thoracic Aorta Geometric Analysis and Planning for Endovascular Repair from Computed Tomography.

Feasibility assessment and planning of thoracic endovascular aortic repair (TEVAR) require computed tomography (CT)-based analysis of geometric aortic features to identify adequate landing zones (LZs) for endograft deployment. However, no consensus exists on how to take the necessary measurements from CT image data. We trained and applied a fully automated pipeline embedding a convolutional neural network (CNN), which feeds on 3D CT images to automatically segment the thoracic aorta, detects proximal landing zones (PLZs), and quantifies geometric features that are relevant for TEVAR planning. For 465 CT scans, the thoracic aorta and pulmonary arteries were manually segmented; 395 randomly selected scans with the corresponding ground truth segmentations were used to train a CNN with a 3D U-Net architecture. The remaining 70 scans were used for testing. The trained CNN was embedded within computational geometry processing pipeline which provides aortic metrics of interest for TEVAR planning. The resulting metrics included aortic arch centerline radius of curvature, proximal landing zones (PLZs) maximum diameters, angulation, and tortuosity. These parameters were statistically analyzed to compare standard arches vs. arches with a common origin of the innominate and left carotid artery (CILCA). The trained CNN yielded a mean Dice score of 0.95 and was able to generalize to 9 pathological cases of thoracic aortic aneurysm, providing accurate segmentations. CILCA arches were characterized by significantly greater angulation (p = 0.015) and tortuosity (p = 0.048) in PLZ 3 vs. standard arches. For both arch configurations, comparisons among PLZs revealed statistically significant differences in maximum zone diameters (p < 0.0001), angulation (p < 0.0001), and tortuosity (p < 0.0001). Our tool allows clinicians to obtain objective and repeatable PLZs mapping, and a range of automatically derived complex aortic metrics.