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 < .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 favourable clinical outcomes in patients at risk for coronary obstruction undergoing TAVI.

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.

Comparison of hemodynamics in biological surgical aortic valve replacement and transcatheter aortic valve implantation: An in-silico study.

OBJECTIVES: In aortic valve replacement (AVR), the treatment strategy as well as the model and size of the implanted prosthesis have a major impact on the postoperative hemodynamics and thus on the clinical outcome. Preinterventional prediction of the hemodynamics could support the treatment decision. Therefore, we performed paired virtual treatment with transcatheter AVR (TAVI) and biological surgical AVR (SAVR) and compared hemodynamic outcomes using numerical simulations. METHODS: 10 patients with severe aortic stenosis (AS) undergoing TAVI were virtually treated with both biological SAVR and TAVI to compare post-interventional hemodynamics using numerical simulations of peak-systolic flow. Virtual treatment procedure was done using an in-house developed tool based on position-based dynamics methodology, which was applied to the patient's anatomy including LVOT, aortic root and aorta. Geometries were automatically segmented from dynamic CT-scans and patient-specific flow rates were calculated by volumetric analysis of the left ventricle. Hemodynamics were assessed using the STAR CCM+ software by solving the RANS equations. RESULTS: Virtual treatment with TAVI resulted in realistic hemodynamics comparable to echocardiographic measurements (median difference in transvalvular pressure gradient [TPG]: -0.33 mm Hg). Virtual TAVI and SAVR showed similar hemodynamic functions with a mean TPG with standard deviation of 8.45 ± 4.60 mm Hg in TAVI and 6.66 ± 3.79 mm Hg in SAVR (p = 0.03) while max. Wall shear stress being 12.6 ± 4.59 vs. 10.2 ± 4.42 Pa (p = 0.001). CONCLUSIONS: Using the presented method for virtual treatment of AS, we were able to reliably predict post-interventional hemodynamics. TAVI and SAVR show similar hemodynamics in a pairwise comparison.

Transcatheter Mitral Valve Replacement After Surgical Repair or Replacement: Comprehensive Midterm Evaluation of Valve-in-Valve and Valve-in-Ring Implantation From the VIVID Registry.

BACKGROUND: Mitral valve-in-valve (ViV) and valve-in-ring (ViR) are alternatives to surgical reoperation in patients with recurrent mitral valve failure after previous surgical valve repair or replacement. Our aim was to perform a large-scale analysis examining midterm outcomes after mitral ViV and ViR. METHODS: Patients undergoing mitral ViV and ViR were enrolled in the Valve-in-Valve International Data Registry. Cases were performed between March 2006 and March 2020. Clinical endpoints are reported according to the Mitral Valve Academic Research Consortium (MVARC) definitions. Significant residual mitral stenosis (MS) was defined as mean gradient ≥10 mm Hg and significant residual mitral regurgitation (MR) as ≥ moderate. RESULTS: A total of 1079 patients (857 ViV, 222 ViR; mean age 73.5±12.5 years; 40.8% male) from 90 centers were included. Median STS-PROM score 8.6%; median clinical follow-up 492 days (interquartile range, 76-996); median echocardiographic follow-up for patients that survived 1 year was 772.5 days (interquartile range, 510-1211.75). Four-year Kaplan-Meier survival rate was 62.5% in ViV versus 49.5% for ViR (P<0.001). Mean gradient across the mitral valve postprocedure was 5.7±2.8 mm Hg (≥5 mm Hg; 61.4% of patients). Significant residual MS occurred in 8.2% of the ViV and 12.0% of the ViR patients (P=0.09). Significant residual MR was more common in ViR patients (16.6% versus 3.1%; P<0.001) and was associated with lower survival at 4 years (35.1% versus 61.6%; P=0.02). The rates of Mitral Valve Academic Research Consortium-defined device success were low for both procedures (39.4% total; 32.0% ViR versus 41.3% ViV; P=0.01), mostly related to having postprocedural mean gradient ≥5 mm Hg. Correlates for residual MS were smaller true internal diameter, younger age, and larger body mass index. The only correlate for residual MR was ViR. Significant residual MS (subhazard ratio, 4.67; 95% CI, 1.74-12.56; P=0.002) and significant residual MR (subhazard ratio, 7.88; 95% CI, 2.88-21.53; P<0.001) were both independently associated with repeat mitral valve replacement. CONCLUSIONS: Significant residual MS and/or MR were not infrequent after mitral ViV and ViR procedures and were both associated with a need for repeat valve replacement. Strategies to improve postprocedural hemodynamics in mitral ViV and ViR should be further explored.

Virtual reality in cardiac interventions-New tools or new toys?

Improvementsin medical imaging and a steady increase in computing power are leading to new possibilities in the field of cardiovascular interventions. Interventions can be planned in advance in greater detail, even to the point of simulating procedures. Nevertheless, all techniques are at an early stage of development. It is of utmost importance that tools, especially if they can be used as decision support are intensively validated and their accuracy is demonstrated. In our commentary, we summarize current techniques for impprovements in planning and guiding of procedures, but also critically discuss the downsides of these techniques. Following the work of Kenichi and colleagues, we also discuss necessary steps in advancing new tools and techniques, particularly as they are used in routine clinical practice. We also discuss the role of artificial intelligence, which could play a crucial role in this context in the future.

Partial ring annuloplasty in the management of mitral annular calcification.

Mitral annular calcification (MAC) complicates the management of mitral valve (MV) disease, regardless of its etiology. Strategies to address MV surgery in MAC include two main options with their own pros and cons; respect and resect strategy. Here, we present a case of minimally-invasive MV repair with partial annuloplasty in the management of noncircumferential MAC with respect to strategy. This technique may be an alternative option for rescuing high-risk patients without extensive decalcification.

Lifetime management of aortic valve disease: Aligning surgical and transcatheter armamentarium to set the tone for the present and the future.

Transcatheter aortic valve replacement (TAVR) has already received the green light for high-, intermediate- and low-risk profiles and is an alternative for all patients regardless of age. It is clear that there has been a push towards the use of TAVR in younger and younger patients (<65 years), which has never been formally tested in randomized controlled trials but seems inevitable as TAVR technology makes steady progress. Lifetime management as a concept will set the tone in the field of the structural heart. Some subjects in this scenario arise, including the importance of optimized prosthetic hemodynamics for lifetime care; surgical procedures in the aortic root; management of structural valve degeneration with valve-in-valve procedures (TAVR-in-surgical aortic valve replacement [SAVR] and TAVR-in-TAVR) and redo SAVR; commissural alignment and cusp overlap for TAVR; the rise in the number of surgical procedures for TAVR explantation; and the renewed interest in the Ross procedure. This article reviews all these issues which will become commonplace during heart team meetings and preoperative conversations with patients in the coming years.

Transcatheter mitral valve implantation in the ongoing structural heart revolution.

Transcatheter mitral valve implantation (TMVI) has emerged as a less invasive approach potentially surmounting some of the current hurdles associated with transcatheter edge-to-edge repair and high-risk mitral valve surgery. In this review, we aimed to outline the main scenarios in the TMVI field, highlight current and upcoming devices, and describe challenges and clinical results. Finally, we briefly discuss the future perspectives for this emerging field and how TMVI might further advance the field of transcatheter treatments of mitral valve disease.

David Procedure as Valve-Sparing Root Replacement.

Composite replacement of the aortic root and aortic valve is a valid surgical strategy in a case of annuloaortic ectasia. However, valve-sparing root replacement procedures have become the gold standard in cases with a morphologically intact or at least repairable aortic valve, and offer several advantages compared to conventional replacement techniques. Above all, the David procedure has become established as a well-known valve-sparing root replacement strategy with excellent short- and long-term outcomes, and it has been further applied to additional patient populations with characteristics like a bicuspid aortic valve or in the setting of acute type A aortic dissection. This narrative review offers an overview of the indications as well as the surgical steps of the T. David V procedure, and highlights important key points regarding the surgical feasibility and criteria of patient selection for valve-sparing root replacement.

Right Antero-Lateral Mini-Thoracotomy Surgical Aortic Valve Replacement.

Over the past few decades, the field of minimally invasive cardiac surgery has significantly broadened. Novel surgical and endovascular techniques have been developed for the treatment of aortic valve pathologies. Surgical aortic valve replacement (SAVR) through a right antero-lateral (mini-)thoracotomy (RALT) has gained approval due to its limited postoperative trauma, faster rehabilitation and sufficient pain control. Nevertheless, SAVR RALT has not been adopted by a significant proportion of cardiac surgeons, due, in part, to its technical complexity and steep learning curve. In this review, we discuss the data for minimally invasive aortic valve surgery and describe our operative technique for SAVR RALT.

State of the Art Review of Surgical Techniques for Microaxial Flow Pump Implantation.

Recently, temporary mechanical circulatory support (tMCS) has been increasingly used for cardiogenic shock therapy. Originally designed as a bail-out option for patients who could not be weaned from cardiopulmonary bypass, the indications for tMCS have been expended and now enable us to support a wide range of patients with various cardiac pathologies. Modern tMCS devices include microaxial flow pumps (mAFP) which are small, versatile systems that can provide both acute cardiac support and cardiac protection for high-risk interventions. In this paper, we review different surgical implantation techniques with modern mAFP as well as specific aspects of preoperative indications and patient evaluation.

Comparison of Self-Expanding Bioprostheses for Transcatheter Aortic Valve Replacement in Patients With Symptomatic Severe Aortic Stenosis: SCOPE 2 Randomized Clinical Trial.

BACKGROUND: Few randomized trials have compared bioprostheses for transcatheter aortic valve replacement, and no trials have compared bioprostheses with supra-annular design. The SCOPE 2 trial (Safety and Efficacy Comparison of Two TAVI Systems in a Prospective Randomized Evaluation 2) was designed to compare the clinical outcomes of the ACURATE neo and CoreValve Evolut bioprostheses for transcatheter aortic valve replacement. METHODS: SCOPE 2 was a randomized trial performed at 23 centers in 6 countries between April 2017 and April 2019. Patients ≥75 years old with an indication for transfemoral transcatheter aortic valve replacement as agreed by the heart team were randomly assigned to receive treatment with either the ACURATE neo (n=398) or the CoreValve Evolut bioprostheses (n=398). The primary end point, powered for noninferiority of the ACURATE neo bioprosthesis, was all-cause death or stroke at 1 year. The key secondary end point, powered for superiority of the ACURATE neo bioprosthesis, was new permanent pacemaker implantation at 30 days. RESULTS: Among 796 randomized patients (mean age, 83.2±4.3 years; mean Society of Thoracic Surgeons Predicted Risk of Mortality score, 4.6±2.9%), clinical follow-up information was available for 778 (98%) patients. Within 1 year, the primary end point occurred in 15.8% of patients in the ACURATE neo group and in 13.9% of patients in the CoreValve Evolut group (absolute risk difference, 1.8%, upper 1-sided 95% confidence limit, 6.1%; P=0.0549 for noninferiority). The 30-day rates of new permanent pacemaker implantation were 10.5% in the ACURATE neo group and 18.0% in the CoreValve Evolut group (absolute risk difference, -7.5% [95% CI, -12.4 to -2.60]; P=0.0027). No significant differences were observed in the components of the primary end point. Cardiac death at 30 days (2.8% versus 0.8%; P=0.03) and 1 year (8.4% versus 3.9%; P=0.01), and moderate or severe aortic regurgitation at 30 days (10% versus 3%; P=0.002) were significantly increased in the ACURATE neo group. CONCLUSIONS: Transfemoral transcatheter aortic valve replacement with the self-expanding ACURATE neo did not meet noninferiority compared with the self-expanding CoreValve Evolut in terms of all-cause death or stroke at 1 year, and it was associated with a lower incidence of new permanent pacemaker implantation. In secondary analyses, the ACURATE neo was associated with more moderate or severe aortic regurgitation at 30 days and cardiac death at 30 days and 1 year. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03192813.

The effect of transcatheter aortic valve implantation approaches on mortality.

OBJECTIVES: We aimed to evaluate the effect of transcatheter aortic valve implantation (TAVI) approaches on mortality and identify effect modifiers and predictors for mortality. BACKGROUND: Alternative access routes to transfemoral (TF) TAVI include the surgical intra-thoracic direct-aortic (DA) and transapical (TA) approach. TA TAVI has been associated with a higher mortality rate. We hypothesized that this is related to effect modifiers, in particular the left ventricular ejection fraction (LVEF). METHODS: This multicentre study derived its data from prospective registries. To adjust for confounders, we used propensity-score based, stabilized inverse probability weighted Cox regression models. RESULTS: In total, 5,910 patients underwent TAVI via TF (N = 4,072), DA (N = 524), and TA (N = 1,314) access. Compared to TF, 30-day mortality was increased among DA (HR 1.87, 95%CI 1.26-2.78, p = .002) and TA (HR 3.34, 95%CI 2.28-4.89, p < .001) cases. Compared to TF, 5-year mortality was increased among TA cases (HR 1.50, 95%CI 1.24-1.83, p < .001). None of the variables showed a significant interaction between the approaches and mortality. An impaired LVEF (≤35%) increased mortality in all approaches. CONCLUSIONS: The surgical intra-thoracic TA and DA TAVI are both associated with a higher 30-day mortality than TF TAVI. TA TAVI is associated with a higher 5-year mortality than TF TAVI. The DA approach may therefore have some advantages over the TA approach when TF access is not feasible.

Minithoracotomy versus full sternotomy for isolated aortic valve replacement: Propensity matched data from two centers.

BACKGROUND: Minimally invasive approaches to isolated aortic valve replacement (AVR) continue to gain popularity. This study compares outcomes of AVR through right anterolateral thoracotomy (RALT) to those of AVR through full median sternotomy (MS). METHODS: Outcomes of two propensity-matched groups of 85 each, out of 250 patients that underwent isolated AVR through RALT or MS at our two institutions, were compared in a retrospective study. RESULTS: Propensity score matching resulted in 85 matched pairs with balanced preoperative characteristics. Procedure times were significantly shorter in the RALT group (median difference: 13 min [-25 to -0.5]; p = .039), cardiopulmonary bypass times were longer (median difference: 17 min [10-23.5]; p = < .001) and ventilation times shorter (median difference: 259 min [-390 to -122.5]; p = < .001). There was no significant difference in aortic cross-clamp times (median difference: 1.5 min [-3.5 to 6.5]; p = .573). The RALT group had lower rates of perioperative platelet transfusions (odds ratio [OR] = 0.00 [0.00-0.59]; p = .0078) and postoperative pneumonia (OR = 0.10 [0.00-0.70]; p = .012), as well as shorter hospitalization times (median difference: 2.5 days [-4.5 to -1]; p = .005). There were no significant differences regarding paravalvular leakage (p = .25), postoperative stroke (p = 1), postoperative atrial fibrillation (p = .12) or 1-year-mortality (p = 1). CONCLUSIONS: This study found RALT to be an equally safe approach to surgical AVR as MS. Furthermore, RALT showed advantages regarding important aspects of postoperative recovery, especially concerning pulmonary function.

Surgical Implantation Techniques of Modern Continuous Flow Ventricular Assist Devices.

Implantable left ventricular assist devices (durable LVADs) have dramatically improved mortality and morbidity in patients with advanced heart failure. Originally designed as a bridge or candidacy to heart transplantation, the indications extend toward permanent support and palliation. Modern durable continuous flow LVADs are small, commercially available, and allow for different surgical approaches to a wide range of patients with various cardiac pathologies. We will review different surgical implantation techniques of modern continuous flow LVADs, as well as specific aspects of preoperative patient evaluation and planning.

State of the Art Review: Surgical Treatment of Acute Type A Aortic Dissection.

Acute type A aortic dissection (ATAAD) is a life-threatening event that requires immediate surgical treatment. Improvements in surgical treatment, graft technology, organ protection and imaging techniques have led to improved clinical outcomes. Individualized treatment concepts have emerged based on more advanced planning tools that allow for a tailored approach even in complex situations such as multi-level malperfusion. This review provides an overview of the current surgical treatment of ATAAD, focusing on new disease classifications, preoperative computed tomography angiography (CTA) assessment, new prosthesis and stent technologies, and organ-protection strategies.

Techniques for Robotic-Assisted Surgical Myocardial Revascularization.

The two current strategies for robotic-assisted, surgical myocardial revascularization are minimally invasive direct coronary artery bypass (MIDCAB) and totally endoscopic coronary artery bypass grafting (TECAB). We discuss the rationale underlying the benefits of robotic assistance in surgical myocardial revascularization, and detail the technical steps to safely and effectively perform these two procedures.

Surgical explantation of a partially detached cardioband device.

Transcatheter repair systems are becoming increasingly popular as a potential solution for high-risk and inoperable patients with mitral regurgitation. The cardioband (Edwards Lifesciences, Irvine, California) is a transcatheter direct annuloplasty device, based on the concept of an undersized ring annuloplasty. We report a case of minimally invasive surgical explantation of a failed cardioband device 21 months after its implantation. Intraoperatively, it was found that three anchors of the cardioband device were detached from the posterior annulus at P2. In this report, a "cut and unscrew" technique with some tips and tricks is presented for the removal of the device.

Minimally invasive surgical aortic valve replacement: The RALT approach.

Less-invasive techniques for cardiothoracic surgical procedures are designed to limit surgical trauma, but the technical requirements and preoperative planning are more demanding than those for conventional sternotomy. Patient selection, interdisciplinary collaboration, and surgical skills are key factors for procedural success. Aortic valve replacement is frequently performed through an upper hemisternotomy, but the right anterior minithoracotomy represents an even less traumatic, technical advancement. Preoperative assessment of the ascending aorta in relation to the sternum is mandatory to select patients and the intercostal access site. This description of the surgical technique focuses on the specific procedural details including the obligatory planning with computed tomography and our cannulation strategy. We also sought to define the anatomical ascending aorta-sternal relationship, as it is of utmost importance in preoperative computed tomographic planning.

Transcatheter aortic valve implantation and its impact on mitral valve geometry and function.

BACKGROUND: The aim of this study was to evaluate the impact of transcatheter aortic valve implantation (TAVI) on mitral valve geometry and function. METHODS: Eighty-four patients underwent TAVI. Forty-four (52%) patients received a balloon-expandable valve and 40 (48%) were implanted with a self-expandable valve. All patients underwent three-dimensional-volumetric transesophageal echocardiography of the mitral valve before and immediately after TAVI. A dedicated software was used for assisted semiautomatic measurement of mitral annular geometry. RESULTS: During systole, the anterior to posterior (AP) diameter was significantly reduced after the procedure (3.4 ± 0.5 cm vs 3.2 ± 0.5 cm; P < .05). The mitral annular area (10.8 ± 2.8cm2 vs 9.9 ± 2.6cm2 ; P < .05) as well as the tenting area (1.6 ± 0.7 cm2 vs 1.2 ± 0.6 cm2 ; P < .001) measured at mid-systole were reduced after TAVI. Diastolic measures were similar. Patients treated with balloon-expandable valves showed a significantly larger reduction in the AP diameter compared to self-expandable valves (-0.25 cm vs -0.11 cm; P < .05). The reduction of the annular area was higher in the balloon-expandable group (-1.2 ± 1.59 vs -0.22 ± 1.41; P < .05). Grade of mitral regurgitation did improve or remained stable after TAVI. CONCLUSION: TAVI significantly impacts the mitral valve and mitral annular geometry and morphology. The choice of the prosthesis (balloon- vs self-expandable) may be relevant for those changes.