Postoperative quality of life and pain after upper hemisternotomy and conventional median sternotomy for aortic valve replacement: results of a randomized clinical trial.

OBJECTIVES: Surgical aortic valve replacement through conventional sternotomy yields excellent results. Minimally invasive techniques are deemed equally safe and serve as a viable and less traumatic alternative. However, it is unclear how both surgical techniques affect patient-reported outcomes. The objective of this trial is to compare postoperative cardiac-related quality of life and postoperative pain after upper hemisternotomy and conventional surgical aortic valve replacement. METHODS: In this single-centre, open-label, investigator-initiated randomized clinical trial, patients were randomized to upper hemisternotomy or conventional full median sternotomy. Patients unable to undergo randomization were monitored prospectively (registry group). Primary outcome was cardiac-specific quality of life, measured with the Kansas City Cardiomyopathy Questionnaire up to 1 year postoperatively. RESULTS: Patients undergoing upper hemisternotomy had a significantly higher physical limitation domain score across all postoperative time points than patients undergoing conventional surgical aortic valve replacement (estimated mean difference 2.12 points; P = 0.014). Patients undergoing upper hemisternotomy were more likely to have a pain score <30 the first 2 days postoperatively than patients undergoing conventional surgical aortic valve replacement (odds ratio 2.63; P = 0.007). This was associated with reduced opioid analgesic intake. Postoperative surgical outcome did not differ between both groups. CONCLUSIONS: Surgical aortic valve replacement through both conventional sternotomy and upper hemisternotomy resulted in clinically similar and important improvements in quality of life, with a small advantage for upper hemisternotomy, while there was no compromise in safety.

Efficacy and safety of hybrid epicardial and endocardial ablation versus endocardial ablation in patients with persistent and longstanding persistent atrial fibrillation: a randomised, controlled trial.

Background: Endocardial catheter ablation (CA) has limited long-term benefit for persistent and longstanding persistent atrial fibrillation (PersAF/LSPAF). We hypothesized hybrid epicardial-endocardial ablation (HA) would have superior effectiveness compared to CA, including repeat (rCA), in PersAF/LSPAF. Methods: CEASE-AF (NCT02695277) is a prospective, multi-center, randomized controlled trial. Nine hospitals in Poland, Czech Republic, Germany, United Kingdom, and the Netherlands enrolled eligible participants with symptomatic, drug refractory PersAF and left atrial diameter (LAD) > 4.0 cm or LSPAF. Randomization was 2:1 to HA or CA by an independent statistician and stratified by site. Treatment assignments were masked to the core rhythm monitoring laboratory. For HA, pulmonary veins (PV) and left posterior atrial wall were isolated with thoracoscopic epicardial ablation including left atrial appendage exclusion. Endocardial touch-up ablation was performed 91-180 days post-index procedure. For CA, endocardial PV isolation and optional substrate ablation were performed. rCA was permitted between days 91-180. Primary effectiveness was freedom from AF/atrial flutter/atrial tachycardia >30-s through 12-months absent class I/III anti-arrhythmic drugs except those not exceeding previously failed doses. It was assessed in the modified intention-to-treat (mITT) population who had the index procedure and follow-up data. Major complications were assessed in the ITT population who had the index procedure. Thirty-six month follow-up continues. Findings: Enrollment began November 20, 2015 and ended May 22, 2020. In 154 ITT patients (102 HA; 52 CA), 75% were male, mean age was 60.7 ± 7.9 years, mean LAD was 4.7 ± 0.4 cm, and 81% had PersAF. Primary effectiveness was 71.6% (68/95) in HA versus 39.2% (20/51) in CA (absolute benefit increase: 32.4% [95% CI 14.3%-48.0%], p < 0.001). Major complications through 30-days after index procedures plus 30-days after second stage/rCA were similar (HA: 7.8% [8/102] versus CA: 5.8% [3/52], p = 0.75). Interpretation: HA had superior effectiveness compared to CA/rCA in PersAF/LSPAF without significant procedural risk increase. Funding: AtriCure, Inc.

Evaluating the Arteriotomy Size of a New Sutureless Coronary Anastomosis Using a Finite Volume Approach.

OBJECTIVES: The ELANA® Heart Bypass creates a standardized sutureless anastomosis. Hereby, we investigate the influence of arteriotomy and graft size on coronary hemodynamics. METHODS: A computational fluid dynamics (CFD) model was developed. Arteriotomy size (standard 1.43 mm2; varied 0.94 - 3.6 mm2) and graft diameter (standard 2.5 mm; varied 1.5 - 5.0 mm) were independent parameters. Outcome parameters were coronary pressure and flow, and fractional flow reserve (FFR). RESULTS: The current size ELANA (arteriotomy 1.43 mm2) presented an estimated FFR 0.65 (39 mL/min). Enlarging arteriotomy increased FFR, coronary pressure, and flow. All reached a maximum once the arteriotomy (2.80 mm2) surpassed the coronary cross-sectional area (2.69 mm2, i.e. 1.85 mm diameter), presenting an estimated FFR 0.75 (46 mL/min). Increasing graft diameter was positively related to FFR, coronary pressure, and flow. CONCLUSION: The ratio between the required minimal coronary diameter for application and the ELANA arteriotomy size effectuates a pressure drop that could be clinically relevant. Additional research and eventual lengthening of the anastomosis is advised.

Mitral Valve Repair Versus Replacement in The Elderly.

The disadvantages of mitral valve replacement with a bioprosthesis in the long-term may not play an important role if the shorter life expectancy of older patients is taken into account. This study aims to evaluate whether mitral valve replacement in the elderly is associated with similar outcome compared to repair in the short- and long-term. All patients aged 70 years and older undergoing minimally invasive mitral valve surgery were studied retrospectively. Primary outcome was 30-day complication rate, secondary outcome was long-term survival and freedom from re-operation. 223 Patients underwent surgery (124 replacement and 99 repair) with a mean age of 76.4 ± 4.2 years. 30-Day complication rate (replacement 73.4% versus repair 67.7%; p=.433), 30-day mortality (replacement 4.0% versus repair 1.0%; p=.332) and 30-day stroke rate (replacement 0.0% versus repair 1.0%; p=.910) were similar in both groups. Multivariable cox regression revealed higher age, diabetes and left ventricular dysfunction as predictors for reduced long-term survival, while a valve replacement was no predictor for reduced survival. Sub analysis of patients with degenerative disease showed no difference in long-term survival after propensity weighting (HR 1.4; 95%CI 0.84 - 2.50; p=.282). The current study reveals that mitral valve repair and replacement in the elderly can be achieved with good short- and long-term results. Long-term survival was dependent on patient related risk factors and not on the type of operation (replacement versus repair).

Ventricular septal defect following port-access mechanical mitral valve replacement.

Interventricular septum defects are a known complication after an aortic valve replacement, but not after mitral surgery. We present a case of a 65-year-old female who underwent unsuccessful mitral valvuloplasty through port-access surgery, followed by uneventful mechanical bioprosthesis replacement. Postoperatively, the patient experienced multiple arrhythmias and recovered poorly. A systolic murmur led to echocardiography, showing an interventricular septum rupture. This was closed with 2 polypropylene pledgeted mattress sutures, via the right atrium and tricuspid valve through midsternal access. The authors believe that the most likely cause is tearing of 2 deeply placed adjacent sutures in the septum, creating localized weakening of the septum susceptible to further rupture. We therefore underline the importance of adequate exposure, especially at the notorious anterior annulus.

Closed-chest unilateral thoracoscopic ablation: box lesion with radiofrequency clamps only.

In this article, we describe the modified technique of a unilateral closed-chest thoracoscopic ablation and left atrial appendage closure including a box lesion that is made by radiofrequency clamps only for the treatment of atrial fibrillation. By abandoning the unidirectional pen devices and replacing these by radiofrequency clamps, we aim to further improve the procedural efficacy and shorten operation time while minimizing surgical exposure for the patient.

State-of-the-Art Review: Technical and Imaging Considerations in Novel Transapical and Port-Access Mitral Valve Chordal Repair for Degenerative Mitral Regurgitation.

Degenerative mitral regurgitation (DMR) based on posterior leaflet prolapse is the most frequent type of organic mitral valve disease and has proven to be durably repairable in most cases by chordal repair techniques either by conventional median sternotomy or by less invasive approaches both utilizing extracorporeal circulation and cardioplegic myocardial arrest. Recently, several novel transapical chordal repair techniques specifically targeting the posterior leaflet have been developed as a far less invasive and beating heart (off-pump) alternative to port-access mitral repair. In order to perform a safe and effective minimally invasive mitral chordal repair, thorough knowledge of the anatomy of the mitral valve apparatus and adequate use of multimodality imaging both pre- and intraoperatively are fundamental. In addition, comprehensive understanding of the available novel devices, their delivery systems and the individual procedural steps are required.

Revascularization strategies for patients with established chronic coronary syndrome.

Coronary artery disease is the most common type of cardiovascular disease, leading to high mortality rates worldwide. Although the vast majority can be treated effectively and safely by medical therapy, revascularization strategies remain essential for numerous patients. Outcomes of both percutaneous coronary intervention and coronary artery bypass grafting improve in a rapid pace, resulting from technical innovation and ongoing research. Progress has been achieved by technical improvements in coronary stents, optimal coronary target and graft selection, and the availability of minimally invasive surgical strategies. Besides technical progress, evidence-based patient-tailored decision-making by the Heart Team is the basic precondition for optimal outcome. The combination of fast innovation and long-term clinical evaluations creates a dynamic field. Research outcomes should be carefully interpreted according to the techniques used and the trial's design. Therefore, more and more trial outcomes suggest that revascularization strategies should be tailored towards the specific patient. Although the European Society of Cardiology/European Association for Cardio-Thoracic Surgery guidelines on myocardial revascularization date from 2018 and a large variety of trial outcomes on revascularization strategies in chronic coronary syndrome have been published since, we aim to provide an updated overview within this review.

Preclinical Comparison of Distal Off-Pump Anastomotic Remodeling: Hand-Sewn Versus ELANA Heart Bypass.

Objective: The ELANA Heart Bypass System is a new sutureless technique for coronary anastomoses. A titanium clip connects the graft with the coronary artery, whereafter the arteriotomy is performed by excimer laser. Since this anastomotic construction evidently differs from the standard hand-sewn anastomosis, we aim to evaluate the process of anastomotic healing and remodeling. Methods: Preclinical evaluation of anastomotic remodeling in 42 pigs who underwent off-pump left internal mammary artery to left anterior descending artery anastomosis by either the ELANA Heart Bypass (n = 24) or the hand-sewn (n = 18) technique. Anastomotic remodeling was evaluated by scanning electron microscopy and histology in short-term follow-up intervals up to 3 months. Anastomotic patency is determined by coronary angiography at latest follow-up before termination. Results: The nonendothelial surface of both the ELANA and the hand-sewn anastomoses were covered with neointima from 14 days onwards. Only half the amount of intima hyperplasia was present in the anastomotic surface of the patent ELANA anastomosis, compared with the hand-sewn anastomosis (98 [48-1358] vs 218 [108-296] µm, P = 0.001). Yet patency of the ELANA was inferior to the hand-sewn anastomoses (79% vs 100%, P = 0.06). Conclusions: This study shows the technical perioperative feasibility of the ELANA Heart Bypass System. Although limited intima hyperplasia was observed, hand-sewn anastomoses had superior patency during follow-up. The results of this trial suggest that an additional study with a new prototype is required before clinical implementation.

Reoperative Mitral Valve Surgery Through Port Access.

Minimally invasive mitral valve surgery (MIMVS) has become the standard approach for mitral valve pathology in many centres. The anterolateral mini thoracotomy access is beneficial in reoperative surgery by avoiding repeat sternotomy associated risks. The aim of this study is to analyse the safety of this technique. All patients undergoing reoperative MIMVS between 2008 and 2019 were studied retrospectively. Primary endpoint was 30-day major complications and mortality; secondary outcome was long term survival, reoperation rate and rate of more than moderate recurrent regurgitation. 146 Patients underwent reoperative MIMVS with a mean age of 68 ± 8 years. The composite outcome of 30-day major complication and mortality was 29.5%. 30-Day mortality was 6.2% and stroke rate 3.4%. Survival for the whole cohort was 89.7 ± 2.5% at 1-year, 71.6 ± 4.3% at 5 year and 50.9 ± 5.9% at 8-year follow up. Cox regression analysis revealed reduced left ventricular function (HR 2.8; 95%CI 1.5 - 5.0), GFR < 60 (HR 2.1; 95%CI 1.2 - 3.7) and active endocarditis (HR 6.4; 95%CI 2.7 - 15.4) as variables associated with reduced long-term survival. The cumulative incidence of re-operation after mitral valve replacement was 11.3 ± 3.2% at 5-year and for repair 16.2 ± 7.5% at 5-year. The cumulative incidence of more than moderate recurrent regurgitation after mitral valve repair was 25.4 ± 9.0% at 3-year. Minimally invasive access in reoperative mitral valve surgery in the current study showed similar 30-day mortality and stroke rate compared to repeat sternotomy results reported in literature.

Application of local gentamicin in the treatment of deep sternal wound infection: a randomized controlled trial.

OBJECTIVES: In patients with deep sternal wound infection (DSWI), primary closure of the sternal bone over high negative pressure Redon drains has shown to be a safe and feasible treatment method. Addition of local gentamicin could accelerate healing and improve clinical outcomes. METHODS: We conducted a randomized controlled trial to evaluate the effectiveness of local gentamicin in the treatment of DSWI. In the treatment group, collagenous carriers containing gentamicin were left between the sternal halves during sternal refixation. In the control group, no local antibiotics were used. Primary outcome was hospital stay. Secondary outcomes were mortality, reoperation, wound sterilization time, time till removal of all drains and duration of intravenous antibiotic treatment. RESULTS: Forty-one patients were included in the trial of which 20 were allocated to the treatment group. Baseline characteristics were similar in both groups. Drains could be removed after a median of 8.5 days in the treatment group and 14.5 days in the control group (P-value: 0.343). Intravenous antibiotics were administered for a median of 23.5 days in the treatment group and 38.5 days in the control group (P-value: 0.343). The median hospital stay was 27 days in the treatment group and 28 days in the control group (P-value: 0.873). Mortality rate was 10% in the treatment group and 9.5% in the control group (P-value: 0,959). No side effects were observed. CONCLUSIONS: This randomized controlled trial showed that addition of local gentamicin in the treatment of DSWI did not result in shorter length of stay. CLINICAL TRIAL REGISTRATION NUMBER: 2014-001170-33.

Extracellular matrix remodeling precedes atrial fibrillation: Results of the PREDICT-AF trial.

BACKGROUND: To which extent atrial remodeling occurs before atrial fibrillation (AF) is unknown. OBJECTIVE: The PREventive left atrial appenDage resection for the predICtion of fuTure Atrial Fibrillation (PREDICT-AF) study investigated such subclinical remodeling, which may be used for risk stratification and AF prevention. METHODS: Patients (N = 150) without a history of AF with a CHA2DS2-VASc score of ≥2 at an increased risk of developing AF were included. The left atrial appendage was excised and blood samples were collected during elective cardiothoracic surgery for biomarker discovery. Participants were followed for 2 years with Holter monitoring to determine any atrial tachyarrhythmia after a 50-day blanking period. RESULTS: Eighteen patients (12%) developed incident AF, which was associated with increased tissue gene expression of collagen I (COL1A1), collagen III (COL3A1), and collagen VIII (COL8A2), tenascin-C (TNC), thrombospondin-2 (THBS2), and biglycan (BGN). Furthermore, the fibroblast activating endothelin-1 (EDN1) and sodium voltage-gated channel ß subunit 2 (SCN2B) were associated with incident AF whereas the Kir2.1 channel (KCNJ2) tended to downregulate. The plasma levels of COL8A2 and TNC correlated with tissue expression and predicted incident AF. A gene panel including tissue KCNJ2, COL1A1, COL8A2, and EDN1 outperformed clinical prediction models in discriminating incident AF. CONCLUSION: The PREDICT-AF study demonstrates that atrial remodeling occurs long before incident AF and implies future potential for early patient identification and therapies to prevent AF (ClinicalTrials.gov identifier NCT03130985).

A randomized prospective multicenter trial for stroke prevention by prophylactic surgical closure of the left atrial appendage in patients undergoing bioprosthetic aortic valve surgery--LAA-CLOSURE trial protocol.

Patients undergoing surgical aortic valve replacement (SAVR) are at high risk for atrial fibrillation (AF) and stroke after surgery. There is an unmet clinical need to improve stroke prevention in this patient population. The LAA-CLOSURE trial aims to assess the efficacy and safety of prophylactic surgical closure of the left atrial appendage for stroke and cardiovascular death prevention in patients undergoing bioprosthetic SAVR. This randomized, open-label, prospective multicenter trial will enroll 1,040 patients at 13 European sites. The primary endpoint is a composite of cardiovascular mortality, stroke and systemic embolism at 5 years. Secondary endpoints include cardiovascular mortality, stroke, systemic embolism, bleed fulfilling academic research consortium (BARC) criteria, hospitalization for decompensated heart failure and health economic evaluation. Sample size is based on 30% risk reduction in time to event analysis of primary endpoint. Prespecified reports include 30-day safety analysis focusing on AF occurrence and short-term outcomes and interim analyses at 1 and 3 years for primary and secondary outcomes. Additionally, substudies will be performed on the completeness of the closure using transesophageal echocardiography/cardiac computed tomography and long-term ECG recording at one year after the operation.

Preclinical Feasibility and Patency Analyses of a New Distal Coronary Connector: The ELANA Heart Bypass.

OBJECTIVE: This preclinical study determines the feasibility and 6-month patency rates of a new distal coronary connector, the Excimer Laser Assisted Nonocclusive Anastomosis (ELANA) Heart Bypass. METHODS: Twenty Dutch Landrace pigs received either a hand-sewn (n = 8) or an ELANA (n = 12) left internal thoracic artery to left anterior descending artery anastomosis, using off-pump coronary artery bypass grafting. Six-month patency rates were demonstrated by coronary angiography and histological evaluation. Throughout, procedural details and complication rates were collected. RESULTS: The ELANA Heart Bypass demonstrated 0% mortality and complication rates during follow-up. It was demonstrated feasible, with comparable perioperative flow measurements (ELANA vs hand-sewn, median [min to max], 24 [14 to 28] vs 17 [12 to 31] mL/min; P = 0.601) and fast construction times (3 [3 to 7] vs 31 [26 to 37] min; P < 0.001). Yet, an extra hemostatic stitch was needed in 25% of the ELANA versus 12.5% of the hand-sewn anastomoses. The 6-month patency rate of the ELANA Heart Bypass was 83.3% versus 100% in hand-sewn anastomoses. The 2 occluded ELANA-anastomoses were defined model-based errors. CONCLUSIONS: The ELANA Heart Bypass facilitates a sutureless distal coronary anastomosis. A design change is suggested to improve hemostasis and will be evaluated in future translational studies. This new technique is a potential alternative to hand-sewn anastomoses in (minimally invasive) coronary surgery.

Comparing quality of life and postoperative pain after limited access and conventional aortic valve replacement: Design and rationale of the LImited access aortic valve replacement (LIAR) trial.

BACKGROUND: Surgical aortic valve replacement (SAVR) via limited access approaches ('mini-AVR') have proven to be safe alternative for the surgical treatment of aortic valve disease. However, it remains unclear whether these less invasive approaches are associated with improved quality of life and/or reduced postoperative pain when compared to conventional SAVR via full median sternotomy (FMS). STUDY DESIGN: The LImited access Aortic valve Replacement (LIAR) trial is a single-center, single blind randomized controlled clinical trial comparing 2 arms of 80 patients undergoing limited access SAVR via J-shaped upper hemi-sternotomy (UHS) or conventional SAVR through FMS. In all randomized patients, the diseased native aortic valve is planned to be replaced with a rapid deployment stented bioprosthesis. Patients unwilling or unable to participate in the randomized trial will be treated conventionally via SAVR via FMS and with implantation of a sutured valve prosthesis. These patients will participate in a prospective registry. STUDY METHODS: Primary outcome is improvement in cardiac-specific quality of life, measured by two domains of the Kansas City Cardiomyopathy Questionnaire up to one year after surgery. Secondary outcomes include, but are not limited to: generic quality of life measured with the Short Form-36, postoperative pain, perioperative (technical success rate, operating time) and postoperative outcomes (30-day and one-year mortality), complication rate and hospital length of stay. CONCLUSION: The LIAR trial is designed to determine whether a limited access approach for SAVR ('mini-AVR') is associated with improved quality of life and/or reduced postoperative pain compared with conventional SAVR through FMS.The study is registered at ClinicalTrials.gov, number NCT04012060.

Late Surgical Treatment for Transcatheter Aortic Valve Prosthesis Dysfunction.

Structural valve degeneration, valve thrombosis, or acute infective endocarditis may affect the postprocedural outcome of transcatheter aortic valve implanted (TAVI) prostheses. Data of patients who required late surgical explant of TAVI prostheses were obtained from 8 European centers. There were 13 patients who underwent surgical treatment for TAVI prosthesis failure after original admission due to prosthetic infective endocarditis in 6 patients, structural valve degeneration in 4, and valve thrombosis in 3. Hospital mortality was 15%, and survival at the 2-year follow-up was 71%. Abstract word count: 80.

Minimally invasive mitral valve surgery: a systematic safety analysis.

OBJECTIVE: Minimally invasive surgery is increasingly adopted as an alternative to conventional sternotomy for mitral valve pathology in many centres worldwide. A systematic safety analysis based on a comprehensive list of pre-specified 30-day complications defined by the Mitral Valve Academic Consortium (MVARC) criteria is lacking. The aim of the current study was to systematically analyse the safety of minimally invasive mitral valve surgery in our centre based on the MVARC definitions. METHODS: All consecutive patients undergoing minimally invasive mitral valve surgery through right mini-thoracotomy in our institution within 10 years were studied retrospectively. The primary outcome was a composite of 30-day major complications based on MVARC definitions. RESULTS: 745 patients underwent minimally invasive mitral valve surgery (507 repair, 238 replacement), with a mean age of 62.9±12.3 years. The repair was successful in 95.8%. Overall 30-day mortality was 1.2% and stroke rate 0.3%. Freedom from any 30-day major complications was 87.2%, and independent predictors were left ventricular ejection fraction <50% (OR 1.78; 95% CI 1.02 to 3.02) and estimated glomerular filtration rate <60 mL/min/1.73 m2 (OR 1.98; 95% CI 1.17 to 3.26). CONCLUSIONS: Minimally invasive mitral valve surgery is a safe technique and is associated with low 30-day mortality and stroke rate.