Leaflet modification before transcatheter aortic valve implantation in patients at risk for coronary obstruction: the ShortCut study.

BACKGROUND AND AIMS: This trial sought to assess the safety and efficacy of ShortCut, the first dedicated leaflet modification device, prior to transcatheter aortic valve implantation (TAVI) in patients at risk for coronary artery obstruction. METHODS: This pivotal prospective study enrolled patients with failed bioprosthetic aortic valves scheduled to undergo TAVI and were at risk for coronary artery obstruction. The primary safety endpoint was procedure-related mortality or stroke at discharge or 7 days, and the primary efficacy endpoint was per-patient leaflet splitting success. Independent angiographic, echocardiographic, and computed tomography core laboratories assessed all images. Safety events were adjudicated by a clinical events committee and data safety monitoring board. RESULTS: Sixty eligible patients were treated (77.0 ± 9.6 years, 70% female, 96.7% failed surgical bioprosthetic valves, 63.3% single splitting and 36.7% dual splitting) at 22 clinical sites. Successful leaflet splitting was achieved in all (100%; 95% confidence interval [CI] 94-100.0%, p<0.001) patients. Procedure time, including imaging confirmation of leaflet splitting, was 30.6 ± 17.9 min. Freedom from the primary safety endpoint was achieved in 59 (98.3%; 95% CI [91.1-100%]) patients, with no mortality and one (1.7%) disabling stroke. At 30 days, freedom from coronary obstruction was 95% (95% CI 86.1-99.0%). Within 90 days, freedom from mortality was 95% (95% CI 86.1-99.0%]), without any cardiovascular deaths. CONCLUSIONS: Modification of failed bioprosthetic aortic valve leaflets using ShortCut was safe, achieved successful leaflet splitting in all patients, and was associated with favorable clinical outcomes in patients at risk for coronary obstruction undergoing TAVI.

The Ascyrus Medical Dissection Stent: A One-Fits-All Strategy for the Treatment of Acute Type A Aortic Dissection?

The treatment of DeBakey type I aortic dissection remains a major challenge in the field of aortic surgery. To upgrade the standard of care hemiarch replacement, a novel device called an "Ascyrus Medical Dissection Stent" (AMDS) is now available. This hybrid device composed of a proximal polytetrafluoroethylene cuff and a distal non-covered nitinol stent is inserted into the aortic arch and the descending thoracic aorta during hypothermic circulatory arrest in addition to hemiarch replacement. Due to its specific design, it may result in a reduced risk for distal anastomotic new entries, the effective restoration of branch vessel malperfusion and positive aortic remodeling. In this narrative review, we provide an overview about the indications and the technical use of the AMDS. Additionally, we summarize the current available literature and discuss potential pitfalls in the application of the AMDS regarding device failure and aortic re-intervention.

Subcostal bilateral internal thoracic artery harvesting with the da Vinci Single Port system: an experimental feasibility study.

We evaluated the feasibility of harvesting bilateral internal thoracic arteries with the da Vinci Single Port system (SP) through a single left-sided subcostal incision. Complete bilateral mobilization with sufficiently long conduits for multivessel grafting was possible in 2 human cadavers and 2 live porcine. Creating the subcostal access and docking the SP system took between 14 and 21 min and the total harvest time ranged from 65 to 125 min in all models. No major bleeding was observed in the live porcine and hemostasis was managed with the available instrumentation. One porcine deceased during surgery due to ventricular fibrillation followed by cardiac arrest. The robotic harvesting was technically easily reproduced by the surgeons and required no additional rib-spreading. Further studies will be required to assess if this subcostal approach with the da Vinci SP system yields true clinical benefits in patients.

Clinical Impact of the Endo-aortic Clamp for Redo Mitral Valve Surgery.

Aim of this study was to compare redo MV surgery patients undergoing right mini-thoracotomy and EAC with redo MV patients undergoing surgery through other approaches. Redo MV patients from 7 European centers were analyzed. Primary endpoint was 30-day mortality; secondary endpoints were stroke, re-exploration, low cardiac output syndrome (LCOS), respiratory failure, and intensive care unit (ICU) and in-hospital length-of-stay. Forty-nine patients underwent right mini-thoracotomy and EAC (22.7%), and 167 (77.3%) underwent surgery through other approaches (112 sternotomy, 40 unclamped mini-thoracotomies, and 15 mini-thoracotomies with trans-thoracic clamp). Thirty-day mortality, stroke, re-exploration for bleeding, and weaning failure were comparable. The EAC group showed significant lower rate of LCOS (p = 0.03) and shorter ICU (p = 0.04) and in-hospital length of stay (p = 0.002). The EAC allows the surgeon to reach the aorta, to clamp it, and to deliver the cardioplegia with a "no-touch" technique, with significant improvement in outcomes.

Hybrid noncovered open stents in repair of DeBakey type 1 acute aortic dissections.

OBJECTIVES: The indications for use, evidence base and experience with the novel noncovered open hybrid surgical stents for acute type A aortic dissection repair for concurrent stabilization of the 'downstream' aorta remains limited. We review the evidence base and the development of these stents. METHODS: Data were collected from Pubmed/Medline literature search to develop and review the evidence base for safety and efficacy of non-covered surgical stents. Existing guidelines for use and developments were reviewed. RESULTS: A single randomized control trial and 4 single-centre studies were included in the review with a total worldwide experience of 241 patients. The deployment was easy and did not add significantly to the primary operation. The mortality and new stroke ranged from 6.3-18.7%. Safe and complete deployment was accomplished in 92-100%. There was no device-related reintervention. There was a significant improvement in malperfusion in over 90% of the cases with varying degrees of remodelling (60-90%) of the downstream aorta. CONCLUSIONS: Open noncovered stent grafts represent a major technical advancement as an adjunct procedure for acute dissection repairs, e.g. hemiarch repair. It has potential for wider use by non-aortic surgeons due to simplicity of technique. Limited safety and efficacy data confirm the device to be safe, feasible and reproducible with potential for wider adoption. However, long-term trial and registry data are required before recommendations for standard use outside of high-volume experienced aortic centres.

The Influence of Audiovisual Distraction on Pain Reduction During Transcatheter Aortic Valve Implantation Under Monitored Anesthesia Care: A Prospective Randomized Trial.

OBJECTIVES: To investigate the effect of an audiovisual distraction system on the dose of remifentanil for perioperative sedation during transcatheter aortic valve implantation under monitored anesthesia care. DESIGN: Single-center prospective randomized nonblinded study. SETTING: Tertiary referral academic hospital. PARTICIPANTS: Ninety patients who underwent transfemoral transcatheter aortic valve implantation between July 2019 and July 2021. INTERVENTIONS: Patients were randomized to use either a novel audiovisual distraction system during the intervention (n = 45) or standard care without an audiovisual distraction system (n = 45). MEASUREMENTS AND MAIN RESULTS: Standardized questionnaires were given to each patient at admission and before and after the intervention to assess their levels of anxiety. Primary endpoints were the average and peak infusion rates of remifentanil. All patients were considered for the final analysis according to an intention-to-treat design. No relevant differences in pre- and postinterventional anxiety status were observed between the groups. Similarly, there were no significant differences in reported pain scores (p = 0.364). The average infusion rate (p = 0.028) and peak infusion rate (p = 0.025) of remifentanil were lower in the group with an audiovisual distraction system. CONCLUSIONS: Audiovisual distraction is a useful adjunct to reduce the dose of remifentanil under monitored anesthesia care during transcatheter aortic valve implantation. Larger studies are needed to evaluate potential positive effects on patient satisfaction, incidence of delirium, and possible economic benefits.

Pacemaker implantation after concomitant tricuspid valve repair in patients undergoing minimally invasive mitral valve surgery: Results from the Mini-Mitral International Registry.

Objective: Randomized evidence suggests a high risk of pacemaker implantation for patients undergoing mitral valve (MV) surgery with concomitant tricuspid valve repair (cTVR). We investigated the impact of cTVR on outcomes in the Mini-Mitral International Registry. Methods: From 2015 to 2021, 7513 patients underwent minimally invasive MV with or without cTVR in 17 international centers (MV: n = 5609, cTVR: n = 1113). Propensity matching generated 1110 well-balanced pairs. Multivariable analysis was applied. Results: Patients with cTVR were older and had more comorbidities. Propensity matching eliminated most differences except for more TR in patients who underwent cTVR (77.2% vs 22.1% MV, P < .001). Mean matched age was 71 years, and 45% were male. European System for Cardiac Operative Risk Evaluation II was still 2.68% (interquartile range [IQR], 0.80-2.63) vs 1.9% (IQR, 1.12-3.9) in matched MV (P < .001). MV replacement (30%) and atrial fibrillation surgery (32%) were similar in both groups. Cardiopulmonary bypass (161 minutes [IQR, 133-203] vs MV: 130 minutes [IQR, 103-166]; P < .001) and crossclamp times (93 minutes [IQR, 66-123] vs MV: 83 minutes [IQR, 64-107]; P < .001) were longer with cTVR. Although in-hospital mortality was similar (cTVR: 3.3% vs MV: 2.2%; P = .5), postoperative pacemaker implantations (9% vs MV: 5.8%; P = .02), low cardiac output syndrome (7.7% vs MV: 4.4%; P = .02), and acute kidney injury (13.8% vs MV: 10%; P = .01) were more frequent with cTVR. cTVR eliminated relevant TR in most patients (greater-than-moderate TR: 6.8%). Multivariable analysis identified MV replacement, atrial fibrillation, and cTVR as risk factors of postoperative pacemaker implantation. Conclusions: cTVR in minimally invasive MV surgery is an independent risk factor for pacemaker implantation in this international registry. It is also associated with more bleeding, low output syndrome, and acute kidney injury. It remains unclear whether technical or patient factors (or both) explain these differences.

Transcatheter management of pure native aortic valve regurgitation in patients with left ventricular assist device.

OBJECTIVES: Aortic valve regurgitation (AR) frequently complicates the clinical course after left ventricular assist device (LVAD) implantation. Transcatheter aortic valve implantation (TAVI) has emerged as an alternative to surgical aortic valve replacement (SAVR) in this cohort with a mostly high surgical risk profile. The unique challenges in LVAD patients, such as presence of non-calcified aortic valves and annular dilatation, raise concerns about device migration and paravalvular leakage (PVL) leading to missing device success. This study evaluates procedural outcomes and survival rates in LVAD patients who underwent TAVI, emphasizing strategies to enhance device success. METHODS: Between January 2017 and April 2023, 27 LVAD patients with clinically significant AR underwent elective or urgent TAVI at our centre. Primary end-points were procedural success rates, without the need for a second transcatheter heart valve (THV) and postprocedural AR/PVL. Secondary outcomes included survival rates and adverse events. RESULTS: Among the cohort, 14.8% received AR-dedicated TAVI devices, with none requiring a second THV. There was no intraprocedural AR, and 1 patient (25%) had AR > 'trace' at discharge. Additionally, 25.9% underwent device landing zone (DLZ) pre-stenting with a standard TAVI device, all without needing a second THV. There was no intraprocedural AR, and none to trace AR at discharge. Among the 59.3% receiving standard TAVI devices, 37.5% required a second THV. In this subgroup, intraprocedural AR > 'trace' occurred in 12.5%, decreasing to 6.25% at discharge. In-hospital mortality was 3.7%, and median follow-up survival was 388 days (interquartile range 208-1167 days). CONCLUSIONS: TAVI yields promising procedural outcomes and early survival rates in LVAD patients with AR. Tailored TAVI devices and pre-stenting techniques enhance procedural success. Continued research into these strategies is essential to optimize outcomes in this complex patient cohort.

Analysis of factors affecting outcome in acute type A aortic dissection complicated by preoperative cardiopulmonary resuscitation.

OBJECTIVES: Cardiopulmonary resuscitation (CPR) aggravates the pre-existing dismal prognosis of patients suffering from acute type A aortic dissection (ATAAD). We aimed to identify factors affecting survival and outcome in ATAAD patients requiring CPR at presentation at 2 European aortic centres. METHODS: Data on 112 surgical candidates and undergoing preoperative CPR were retrospectively evaluated. Patients were divided into 2 groups according to 30-day mortality. A multivariable model identified predictors for 30-day mortality. RESULTS: Preoperative death occurred in 23 patients (20.5%). In the remaining 89 surgical patients (79.5%) circulatory arrest time (41 ± 20 min in 30-day non-survivors vs 30 ± 13 min in 30-day survivor, P = 0.003) as well as cardiopulmonary bypass time (320 ± 132 min in 30-day non-survivors vs 252 ± 140 min in 30-day survivor, P = 0.020) time was significantly longer in patients with worse outcome. Thirty-day mortality of the total cohort was 61.6% (n = 69) with cardiac failure in 48% and aortic rupture or haemorrhagic shock (28%) as predominant reasons of death. Age [odds ratio (OR) 1.04, 95% confidence interval (CI) 1.01-1.09, P = 0.034], preoperative coronary (OR 3.42, 95% CI 1.34-9.26, p = 0.012) and spinal malperfusion (OR 12.49, 95% CI 1.83-225.02, P = 0.028) emerged as independent predictors for 30-day mortality while CPR due to tamponade was associated with improved early survival (OR 0.29, 95% CI 0.091-0.81, P = 0.023). CONCLUSIONS: Assessment of underlying cause for CPR is mandatory. Pericardial tamponade, rapidly resolved with pericardial drainage, is a predictor for improved survival, while age and presence of coronary and spinal malperfusion are associated with dismal outcome in this high-risk patient group.

Clinical and Hemodynamic Outcomes of Balloon-Expandable Mitral Valve-in-Valve Positioning and Asymmetric Deployment: The VIVID Registry.

BACKGROUND: Mitral valve-in-valve (ViV) is associated with suboptimal hemodynamics and rare left ventricular outflow tract (LVOT) obstruction. OBJECTIVES: This study aimed to determine whether device position and asymmetry are associated with these outcomes. METHODS: Patients undergoing SAPIEN 3 (Edwards Lifesciences) mitral ViV included in the VIVID (Valve-in-Valve International Data) Registry were studied. Clinical endpoints are reported according to Mitral Valve Academic Research Consortium definitions. Residual mitral valve stenosis was defined as mean gradient ≥5 mm Hg. Depth of implantation (percentage of transcatheter heart valve [THV] atrial to the bioprosthesis ring) and asymmetry (ratio of 2 measures of THV height) were evaluated. RESULTS: A total of 222 patients meeting the criteria for optimal core lab evaluation were studied (age 74 ± 11.6 years; 61.9% female; STS score = 8.3 ± 7.1). Mean asymmetry was 6.2% ± 4.4%. Mean depth of implantation was 19.0% ± 10.3% atrial. Residual stenosis was common (50%; mean gradient 5.0 ± 2.6 mm Hg). LVOT obstruction occurred in 7 cases (3.2%). Implantation depth was not a predictor of residual stenosis (OR: 1.19 [95% CI: 0.92-1.55]; P = 0.184), but more atrial implantation was protective against LVOT obstruction (0.7% vs 7.1%; P = 0.009; per 10% atrial, OR: 0.48 [95% CI: 0.24-0.98]; P = 0.044). Asymmetry was found to be an independent predictor of residual stenosis (per 10% increase, OR: 2.30 [95% CI: 1.10-4.82]; P = 0.027). CONCLUSIONS: Valve stenosis is common after mitral ViV. Asymmetry was associated with residual stenosis. Depth of implantation on its own was not associated with residual stenosis but was associated with LVOT obstruction. Technical considerations to reduce postdeployment THV asymmetry should be considered.

Case Report: Successful endovascular treatment of acute type A aortic dissection.

Introduction: Open surgical repair remains the current gold standard for the treatment of acute type A aortic dissection. However, especially elderly patients with relevant comorbidities who are deemed unfit for open surgery may benefit from a minimally invasive endovascular approach. Methods: We report a case of an 80-year-old male with retrograde acute type A aortic dissection and peripheral malperfusion after receiving thoracic endovascular aortic repair due to thoracic aortic aneurysm. Our individualized endovascular approach consisted of left carotid-subclavian bypass, proximal extension of thoracic endovascular aortic repair using a covered stent graft and a single covered stent graft for the ascending aorta in combination with an uncovered stent for the aortic arch. Results: Postoperative computed tomographic angiography demonstrated excellent outcome with no signs of endoleak or patent false lumen. Follow-up after 3.5 years showed a stable result with no signs of stent failure or dissection progress. No aortic re-interventions were needed in the further course. Discussion: An individualized endovascular approach may be justified for acute type A aortic dissection in elderly patients with high surgical risk if performed in specialized aortic centers. Additional short-length stent graft devices are needed to address the anatomical challenges of the ascending aorta. For enhanced remodeling of the dissected aorta, the use of an additional uncovered stent may be advisable.

Neurological outcomes in minimally invasive mitral valve surgery: risk factors analysis from the Mini-Mitral International Registry.

OBJECTIVES: The aim of this study was to examine the incidence and predictors of stroke after minimally invasive mitral valve surgery (mini-MVS) and to assess the role of preoperative CT scan on surgical management and neurological outcomes in the large cohort of Mini-Mitral International Registry. METHODS: Clinical, operative and in-hospital outcomes in patients undergoing mini-MVS between 2015 and 2021 were collected. Univariable and multivariable analyses were used to identify predictors of stroke. Finally, the impact of preoperative CT scan on surgical management and neurological outcomes was assessed. RESULTS: Data from 7343 patients were collected. The incidence of stroke was 1.3% (n = 95/7343). Stroke was associated with higher in-hospital mortality (11.6% vs 1.5%, P < 0.001) and longer intubation time, ICU and hospital stay (median 26 vs 7 h, 120 vs 24 h and 14 vs 8 days, respectively). On multivariable analysis, age (odds ratio 1.039, 95% confidence interval 1.019-1.060, P < 0.001) and mitral valve replacement (odds ratio 2.167, 95% confidence interval 1.401-3.354, P < 0.001) emerged as independent predictors of stroke. Preoperative CT scan was made in 31.1% of cases. These patients had a higher risk profile and EuroSCORE II (median 1.58 vs 1.1, P < 0.001). CT scan influenced the choice of cannulation site, being ascending aorta (18.5% vs 0.5%, P < 0.001) more frequent in the CT group and femoral artery more frequent in the no CT group (97.8% vs 79.7%, P < 0.001). No difference was found in the incidence of postoperative stroke (CT group 1.5, no CT group 1.4%, P = 0.7). CONCLUSIONS: Mini-MVS is associated with a low incidence of stroke, but when it occurs it has an ominous impact on mortality. Preoperative CT scan affected surgical cannulation strategy but did not led to improved neurological outcomes.

Alternative minimally invasive surgical explantation techniques for failed transcatheter mitral valve repair devices.

Objective: The use of transcatheter mitral valve repair (TMVr) devices is increasing in elderly and high-risk patients. However, the increasing number of patients with recurrent mitral regurgitation (MR) has confronted surgeons with the issue of how to explant the devices and whether the mitral valve should be repaired or replaced. The aim of the study is to summarize our clinical experience with the explantation of different TMVr devices and to provide alternative surgical techniques that can be performed in different clinical scenarios. Methods: A simulator system including a dummy valve representing native valves was used to create video documentation and to develop alternative surgical methods for clip explantation. Moreover, the clip explantation techniques were shown in 2 patients undergoing minimally-invasive mitral valve repair after a failed TMVr. Results: Alternative explantation techniques were described for each TMVr device; 2 techniques for MitraClip and 3 techniques for PASCAL (Precision Transcatheter Valve Repair System), which may be adjusted for each individual according to the underlying valve pathology and the degree of device encapsulation. The patients were discharged without residual MR and remained MR free at the follow-up. Conclusions: Transcatheter edge-to-edge repair devices can be surgically explanted without damaging the MV leaflets. Removal of each device may require a different technique tailored to the degree of device encapsulation and valve pathology. Increasing experience may facilitate repair in patients with recurrent MR after TMVr.

The impact of malperfusion patterns in elderly patients undergoing surgery for acute type A aortic dissection.

OBJECTIVES: The aim of this study is to investigate the outcome of elderly patients with surgically treated acute type A aortic dissection (ATAAD) complicated by malperfusion. METHODS: Patients ≥70 years old who underwent surgical treatment for ATAAD between January 2000 and December 2020 were enrolled in this study and stratified by their specific Penn Classification into 4 different subgroups, where Penn Abc was defined as multilevel malperfusion. Short- and long-term outcomes were investigated. Multivariable binary logistic regression was performed to identify risk factors for 1-year mortality. RESULTS: Four hundred elderly patients underwent surgical treatment for ATAAD. A total of 204 (51%) patients had no evidence of malperfusion (Penn Aa), 106 (26.5%) had localized organic malperfusion (Penn Ab), 44 (11%) patients had systemic malperfusion (Penn Ac) and 46 (11.5%) suffered from multilevel malperfusion (Penn Abc). For the latter, in-hospital mortality was 70% (P < 0.001). Age (P < 0.006) and multilevel malperfusion (P < 0.001) were independent risk factors for 1-year mortality. Patients with multilevel malperfusion showed the worst 1-year survival (P < 0.001). In the case of Penn Aa, in-hospital mortality was 13% (P < 0.001). CONCLUSIONS: Surgery may lead to satisfactory results in the absence of malperfusion, even in octogenarians. Elderly patients with multilevel malperfusion show very poor surgical outcome. In these patients, the decision for surgery should be taken with caution. Operation, if performed, should be carried out by experienced teams only.

Transaxillary implantation of a temporary microaxial left ventricular assist device in a patient with a rectangular kinked subclavian artery.

Transaxillary implantation of a temporary microaxial left ventricular assist device in patients suffering from cardiogenic shock is an established technique. We present a 77-year-old female patient with severe mitral regurgitation. She underwent minimally invasive surgical mitral valve replacement. After an uneventful postoperative course, the patient developed acute heart failure on the 11th postoperative day. Transthoracic echocardiography revealed new onset of Takotsubo cardiomyopathy with a severely decreased left ventricular ejection fraction. Implantation of a microaxial flow pump for left ventricular decompression was scheduled. Preoperative computed tomography revealed a rectangular course of the right subclavian artery. To advance the Impella, we employed an introducer fitted over the guidewire behind the Impella device as a 'cue stick' to move the rigid part of the pump forward to overcome the kinking using a 'shuffleboard technique'. The haemodynamic situation stabilized immediately after implantation. The Impella 5.5 was successfully weaned after 6 days of support. In the event of (rectangular) kinking of the subclavian artery, the 'shuffleboard technique' can be used for the successful positioning of the pump.