Early outcomes of aortic valve replacement with Perceval PLUS sutureless valve: results of the prospective multicentric MANTRA study.

BACKGROUND: The aim of this study is to report the preliminary real-word clinical and hemodynamic performance from the MANTRA study in patients undergoing aortic valve replacement with Perceval PLUS sutureless valve. METHODS: MANTRA is an ongoing "umbrella" prospective, multi-center, international post-market study to collect real-life safety and performance data on Corcym devices (Corcym S.r.l, Saluggia, Italy). Clinical and echocardiographic outcomes were collected preoperatively, at discharge and at each follow up. KCCQ-12 and EQ-5D-5L quality of life questionnaires were collected preoperatively and at 30-days. RESULTS: A total of 328 patients underwent aortic valve replacement with Perceval PLUS in 29 International institutions. Patients were enrolled from July 2021 to October 2023 and enrollment is still ongoing. Mean age was 71.9 ± 6.4 years, mean EuroSCORE II was 2.9 ± 3.9. Minimally invasive approach was performed in 44.2% (145/328) of patients; concomitant procedures were done in 40.8% (134/328) of cases. Thirty-day mortality was 1.8% (6/328) and no re-interventions were reported. Pacemaker implant was required in 4.0% (13/328) of the patients. The assessment of the functional status demonstrated marked and stable improvement in NYHA class in most patients at 30-day follow-up, with significant increase of KCCQ-12 summary score (from 58.8 ± 23.0 to 71.8 ± 22.1, p < 0.0001) and EQ-5D-5L VAS score (from 64.5 ± 20.4 to 72.6 ± 17.5, p < 0.0001). Mean pressure gradient decreased from 46.2 ± 17.3 mmHg to 10.1 ± 4.7 mmHg at 30-day follow-up. Low or no incidence of moderate-to-severe paravalvular or central leak was reported. CONCLUSIONS: Preliminary results demonstrate good clinical outcomes and significant improvement of Quality of Life at 30-days, excellent early hemodynamic performance within patient implanted with Perceval PLUS. TRIAL REGISTRATION: The MANTRA study has been registered in ClinicalTrials.gov (NCT05002543, Initial release 26 July 2021).

Early Conduction Disorders After Aortic Valve Replacement With the Sutureless Perceval Prosthesis.

BACKGROUND: This study was conducted to determine the incidence of postoperative conduction disorders and need for pacemaker (PM) implantation after aortic valve replacement (AVR) with the Perceval prosthesis (Livanova, Saluggia, Italy). METHODS: From January 2007 to December 2017, 908 patients underwent AVR with Perceval S in 5 participating centers. Study end points focused on electrocardiographic changes after AVR and the incidence of new PM implantation in 801 patients after exclusion of patients with previous PM (n = 48) or patients undergoing tricuspid (n = 28) and/or atrial fibrillation ablation (n = 31) surgery. Logistic regression analysis was performed to determine risk factors for PM need. RESULTS: Mean age was 79.7 ± 5.2 years, and 476 (59.4%) were women. Median logistic European System for Cardiac Operative Risk Evaluation (2011 revision) score was 4.1% (interquartile range, 2.6%-6.0%). Isolated AVR was performed in 441 patients (55.1%). Associated procedures were coronary artery bypass grafting in 309 (38.6%) and mitral valve surgery in 51 (6.4%). Overall 30-day mortality was 3.9% and was 2.8% for isolated AVR. Electrocardiographic changes included a significant increase of left bundle branch block from 7.4% to 23.7% (P < .001) and development of complete atrioventricular block requiring PM implantation in 9.5%. Multivariable analysis revealed independent of a learning period (odds ratio [OR], 1.91; 95% confidence limits (CL), 1.16-3.13; P = .011), preexisting right-bundle branch block (OR, 2.77; 95% CL, 1.40-5.48; P = .003), intraoperative prosthesis repositioning (OR, 6.70; 95% CL, 1.89-24.40; P = .003), and size extra large (OR, 6.81; 95% CL, 1.55-29.96; P = .011) as significant predictors of PM implantation. CONCLUSIONS: In a challenging elderly population, use of the Perceval S for AVR provides low operative mortality but at the risk of an increased PM implantation rate. Besides preexisting right bundle branch block, the significant effect of size extra large, an increased valve size/body surface area ratio, and need for intraoperative repositioning on PM rate are underscoring the reappraisal of the annular sizing policy.

The Belgian experience with concomitant surgical ablation of atrial fibrillation: a multi-centre prospective registry.

Background: The Belgian 'National Institute for Health and Disability Insurance (RIZIV-INAMI)' requested prospective collection of data on all ablations in Belgium to determine the outcomes of surgical ablation of atrial fibrillation (AF) during concomitant cardiac surgery.Methods: 890 patients undergoing concomitant ablation for AF between 2011 and 2016 were prospectively followed. Freedom from AF with and without anti-arrhythmic drugs was calculated for 817 patients with follow-up beyond the 3-month blanking period and for 574 patients with sufficient rhythm-related follow-up consisting of at least one Holter registration or a skipped Holter due to AF being evident on ECG. Besides preoperative AF type, concomitant procedure and ablation, potential covariates were entered into uni- and multivariable regression models to determine predictors of outcome.Results: The overall freedom from AF beyond 3 months was 69.9% (571/817) and without anti-arrhythmic drugs at last follow-up 51.0% (417/817), respectively, 61.3% (352/574) and 44.4% (255/574) for patients with sufficient rhythm-related follow-up. Using a Kaplan-Meier estimate, freedom from AF was 89.3%, 74.9% and 59%, without antiarrhythmic drugs 74.4%, 47.8% and 32.3% at 6, 12 and 24 months, respectively. In-hospital mortality was 1.7% (15/890) and the overall survival was 95.0% at 1 year and 92.3% at 2 years. Preoperative left atrial diameter and AF type were significant predictive factors of freedom from AF in a multivariable analysis.Conclusion: Analysis of the Belgian national registry shows that concomitant surgical ablation of atrial fibrillation is safe, achieves favourable freedom from AF and, therefore, deserves to be performed in accordance to the guidelines.

Association between postoperative delirium and postoperative cerebral oxygen desaturation in older patients after cardiac surgery.

BACKGROUND: Near-infrared spectroscopy non-invasively measures regional cerebral oxygen saturation. Intraoperative cerebral desaturations have been associated with worse neurological outcomes. We investigated whether perioperative cerebral desaturations are associated with postoperative delirium in older patients after cardiac surgery. METHODS: Patients aged 70 yr and older scheduled for on-pump cardiac surgery were included between 2015 and 2017 in a single-centre, prospective, observational study. Baseline cerebral oxygen saturation was measured 1 day before surgery. Throughout surgery and after ICU admission, cerebral oxygen saturation was monitored continuously up to 72 h after operation. The presence of delirium was assessed using the confusion assessment method for the ICU. Association with delirium was evaluated with unadjusted analyses and multivariable logistic regression. RESULTS: Ninety-six of 103 patients were included, and 29 (30%) became delirious. Intraoperative cerebral oxygen saturation was not significantly associated with postoperative delirium. The lowest postoperative cerebral oxygen saturation was lower in patients who became delirious (P=0.001). The absolute and relative postoperative cerebral oxygen saturation decreases were more marked in patients with delirium (13 [6]% and 19 [9]%, respectively) compared with patients without delirium (9 [4]% and 14 [5]%; P=0.002 and P=0.001, respectively). These differences in cerebral oxygen saturation were no longer present after excluding cerebral oxygen saturation values after patients became delirious. Older age, previous stroke, higher EuroSCORE II, lower preoperative Mini-Mental Status Examination, and more substantial absolute postoperative cerebral oxygen saturation decreases were independently associated with postoperative delirium incidence. CONCLUSIONS: Postoperative delirium in older patients undergoing cardiac surgery is associated with absolute decreases in postoperative cerebral oxygen saturation. These differences appear most detectable after the onset of delirium. CLINICAL TRIAL REGISTRATION: NCT02532530.

The state of robotic cardiac surgery in Europe.

BACKGROUND: In the past two decades, the introduction of robotic technology has facilitated minimally invasive cardiac surgery, allowing surgeons to operate endoscopically rather than through a median sternotomy. This approach has facilitated procedures for several structural heart conditions, including mitral valve repair, atrial septal defect closure and multivessel minimally invasive coronary artery bypass grafting. In this rapidly evolving field, we review the status of robotic cardiac surgery in Europe with a focus on mitral valve surgery and coronary revascularization. METHODS: Structured searches of MEDLINE, Embase, and Cochrane databases were performed from their dates of inception to June 2016. All original studies, except case-reports, were included in this qualitative review. Studies performed in Europe were presented quantitatively. Data provided from Intuitive Surgical Inc. are also presented. RESULTS: Fourteen papers on coronary surgery were included in the analysis and reported a mortality rate ranging between 0-1%, revision for bleeding between 2-7%, conversion to a larger incision between 2-15%, and patency rate between 92-98%. The number of procedures ranged between 23 and 170 per year. There were only a small number of published reports for robotic mitral valve surgery from European centers. CONCLUSIONS: Coronary robotic surgery in Europe has been performed safely and effectively with very few perioperative complications in the last 15 years. On the other hand, mitral surgery has been developed later with increasing applications of this technology only in the last 5-6 years.

Effective Orifice Area during Exercise in Bileaflet Mechanical Valve Prostheses.

BACKGROUND: The aims of this study were to investigate the evolution of the transprosthetic pressure gradient and effective orifice area (EOA) during dynamic bicycle exercise in bileaflet mechanical heart valves and to explore the relationship with exercise capacity. METHODS: Patients with bileaflet aortic valve replacement (n = 23) and mitral valve replacement (MVR; n = 16) prospectively underwent symptom-limited supine bicycle exercise testing with Doppler echocardiography and respiratory gas analysis. Transprosthetic flow rate, peak and mean transprosthetic gradient, EOA, and systolic pulmonary artery pressure were assessed at different stages of exercise. RESULTS: EOA at rest, midexercise, and peak exercise was 1.66 ± 0.23, 1.56 ± 0.30, and 1.61 ± 0.28 cm2, respectively (P = .004), in aortic valve replacement patients and 1.40 ± 0.21, 1.46 ± 0.27, and 1.48 ± 0.25 cm2, respectively (P = .160), in MVR patients. During exercise, the mean transprosthetic gradient and the square of transprosthetic flow rate were strongly correlated (r = 0.65 [P < .001] and r = 0.84 [P < .001] for aortic valve replacement and MVR, respectively), conforming to fundamental hydraulic principles for fixed orifices. Indexed EOA at rest was correlated with exercise capacity in MVR patients only (Spearman ρ = 0.68, P = .004). In the latter group, systolic pulmonary artery pressures during exercise were strongly correlated with the peak transmitral gradient (ρ = 0.72, P < .001). CONCLUSIONS: In bileaflet mechanical valve prostheses, there is no clinically relevant increase in EOA during dynamic exercise. Transprosthetic gradients during exercise closely adhere to the fundamental pressure-flow relationship. Indexed EOA at rest is a strong predictor of exercise capacity in MVR patients. This should be taken into account in therapeutic decision making and prosthesis selection in young and dynamic patients.

Influence of continuously evolving transcatheter aortic valve implantation technology on cerebral oxygenation.

This study assessed the influence of the evolution in Transcatheter Aortic Valve Implantation technology on cerebral oxygenation. Cerebral oxygenation was measured continuously with Near-Infrared Spectroscopy and compared retrospectively between balloon-expandable, self-expandable and differential deployment valves which were implanted in 12 (34%), 17 (49%) and 6 patients (17%), respectively. Left and right SctO2 values were averaged at four time points and used for analysis (i.e. at baseline, balloon-aortic valvuloplasty, valve deployment, and at the end of the procedure). During balloon-aortic valvuloplasty and valve deployment, cerebral oxygenation decreased in patients treated with balloon or self-expandable valves (balloon-expandable: p = 0.003 and p = 0.002; self-expandable: p < 0.001 and p = 0.003, respectively). The incidence of cerebral desaturations below 80% of baseline was significantly larger in patients treated with balloon-expandable valves (p = 0.001). In contrast, patients who received differential deployment valves never experienced a cerebral desaturation below 80% of baseline. Furthermore, both the incidence and duration below a cerebral oxygenation of 55% was significantly different between balloon and self-expandable valves (p = 0.038 and p = 0.018, respectively). This study demonstrated that Transcatheter Aortic Valve Implantation procedures are associated with significant cerebral desaturations, especially during balloon-aortic valvuloplasty and valve deployment. Moreover, our results showed that latest innovations in Transcatheter Aortic Valve Implantation technology beneficially influenced the adequacy of cerebral perfusion.

Mid-term results of leaflet augmentation in severe tricuspid functional tethering.

OBJECTIVES: Functional tricuspid regurgitation (FTR) is usually managed surgically using various types of annuloplasty. FTR has been reported to recur in up to 45% of patients, with severe leaflet tethering being an important risk factor for recurrence. The aim of this study is to report the clinical and echocardiographic mid-term results after leaflet augmentation in patients with FTR due to severe leaflet tethering. METHODS: From May 2008 to July 2014, 22 patients were found to have a severe FTR with a tethering height of at least 8 mm; all of them underwent leaflet augmentation: the anterior and part of the posterior leaflet were detached from the anterior annulus; a patch of fresh autologous pericardium was used to generously fill the gap between the anterior annulus and the detached leaflet. A 5/0 Pronova suture locked at every step was used to avoid any purse string effect. In 2 patients, the septal leaflet also needed to be augmented using a comparable technique. In all but one (annular calcification) patient, a semi-rigid ring annuloplasty was added. The mean age was 67.1 ± 13.7 years; it was a redo procedure in 12 cases (54.5%), 11 patients (50%) had right ventricle failure and 3 (23.1%) had renal failure. RESULTS: The median follow-up was 2.1 ± 1.9 years. Thirty-day and 4-year survival averaged at 81.1 ± 8.5 and 71.6 ± 9.8%, respectively. At 4 years, 84 ± 10.6% of the survivors were in NYHA class I or II and only 2 patients had a TR of ≥2 with a global freedom from TR ≥2 of 85.7 ± 13.2%. There was no reintervention. CONCLUSIONS: Tricuspid leaflet augmentation combined with annuloplasty is feasible and leads to excellent clinical and echocardiographical mid-term results even in the presence of severe leaflet tethering and right ventricular failure.

Anomalous Origin of the Circumflex Artery: An Underestimated Threat During Mitral Valve Operation.

Ischemic iatrogenic lesions can complicate surgical procedures on the mitral valve. One of the causative mechanisms is direct injury to or distortion of the circumflex coronary artery. The risk of damaging the circumflex coronary artery depends mainly on the proximity of that vessel to the posterior segment of the mitral annulus, and this varies from patient to patient. Herein, we report the case of an iatrogenic circumflex coronary artery lesion after mitral annuloplasty in a patient with an anomalous origin of the circumflex artery.

Mitral valve area during exercise after restrictive mitral valve annuloplasty: importance of diastolic anterior leaflet tethering.

BACKGROUND: Restrictive mitral valve annuloplasty (RMA) for secondary mitral regurgitation might cause functional mitral stenosis, yet its clinical impact and underlying pathophysiological mechanisms remain debated. OBJECTIVES: The purpose of our study was to assess the hemodynamic and clinical impact of effective orifice area (EOA) after RMA and its relationship with diastolic anterior leaflet (AL) tethering at rest and during exercise. METHODS: Consecutive RMA patients (n = 39) underwent a symptom-limited supine bicycle exercise test with Doppler echocardiography and respiratory gas analysis. EOA, transmitral flow rate, mean transmitral gradient, and systolic pulmonary arterial pressure were assessed at different stages of exercise. AL opening angles were measured at rest and peak exercise. Mortality and heart failure readmission data were collected for at least 20 months after surgery. RESULTS: EOA and AL opening angle were 1.5 ± 0.4 cm(2) and 68 ± 10°, respectively, at rest (r = 0.4; p = 0.014). EOA increased significantly to 2.0 ± 0.5 cm(2) at peak exercise (p < 0.001), showing an improved correlation with AL opening angle (r = 0.6; p < 0.001). Indexed EOA (EOAi) at peak exercise was an independent predictor of exercise capacity (maximal oxygen uptake, p = 0.004) and was independently associated with freedom from all-cause mortality or hospital admission for heart failure (p = 0.034). Patients with exercise EOAi <0.9 cm(2)/m(2) (n = 14) compared with ≥0.9 cm(2)/m(2) (n = 25) had a significantly worse outcome (p = 0.048). In multivariate analysis, AL opening angle at peak exercise (p = 0.037) was the strongest predictor of exercise EOAi. CONCLUSIONS: In RMA patients, EOA increases during exercise despite fixed annular size. Diastolic AL tethering plays a key role in this dynamic process, with increasing AL opening during exercise being associated with higher exercise EOA. EOAi at peak exercise is a strong and independent predictor of exercise capacity and is associated with clinical outcome. Our findings stress the importance of maximizing AL opening by targeting the subvalvular apparatus in future repair algorithms for secondary mitral regurgitation.

Mitral valvuloplasty: when the art of repair meets the biological science.

The majority of approaches currently described and practiced in mitral repair surgery result in the vertical immobilization of the posterior leaflet, with the anterior leaflet striving to produce an adequate coaptation. Despite the satisfactory hemodynamic outcome and disappearance of mitral regurgitation, this non-physiological situation results in a redistribution of forces within the mitral apparatus with an increased stress on the leaflets. Biological evidences are pointing at the ability of the valvular interstitial cells to actively respond to biomechanical changes, switching their phenotype and producing different patterns of extracellular matrix proteins. This biological event translates to changes in the anatomical and mechanical properties of the leaflets, leading to an increased stiffening and a susceptibility to develop calcification. These concepts find a clinical reflex in reports on the long-term thickening and calcification of the leaflets after mitral repair, and in the leaflets remodeling phenomena described in chronically dilated ventricles. The importance of respecting the physiological movement and dynamics of the leaflets when performing a valvuloplasty is underlined, and a potential pharmacological modulation of the aforementioned biological processes to ameliorate long-term results of the repair is hypothesized.

Pulmonary homograft endocarditis and aortic autograft failure after Ross procedure: a double stentless bioprosthesis approach.

The case is reported of a 38-year-old male patient with pulmonary homograft acute infective endocarditis and aortic root dilation that occurred 13 years after a Ross procedure for bicuspid aortic valve regurgitation. Aortic and pulmonary root replacements were performed, using a Freestyle stentless aortic root bioprosthesis in both cases, with excellent hemodynamics on postoperative echocardiography. In addition, preoperative systemic septic embolization had occurred despite an absence of left-sided endocarditis, presumably due to an intrapulmonary shunt. This case report demonstrates the feasibility of a double stentless bioprosthesis approach, and stresses the need to remain vigilant for septic embolization even in isolated right-sided endocarditis.

Myectomy and mitral repair through the left atrium in hypertrophic obstructive cardiomyopathy: the preferred approach for contemporary surgical candidates?

OBJECTIVE: Patients with hypertrophic obstructive cardiomyopathy due to diffuse hypertrophy extending to or below the papillary muscles are poor candidates for alcohol septal ablation and suboptimal candidates for transaortic septal myectomy. In addition, the outflow obstruction is often aggravated by an abnormal mitral valve and subvalvular apparatus. METHODS: We performed transatrial myectomy in 12 patients with diffuse hypertrophy, who were highly symptomatic despite maximal medical therapy. All had at least moderate mitral regurgitation and systolic anterior motion. The anterior mitral leaflet (AML) was detached from commissure to commissure, allowing an easy myectomy through this AML toward the base of the anterior papillary muscle, with mobility fully restored. The abnormal chordae from the septum to the anterior papillary muscle and AML were divided. The continuity of this AML was restored with augmentation using an autologous pericardial patch. The height of the posterior mitral leaflet was reduced and the repair completed using an oversized annuloplasty ring. RESULTS: The peak intraventricular gradients decreased spectacularly from 98.8 ± 6.29 to 19.2 ± 13.4 mm Hg (P < .001), and the systolic anterior motion and mitral regurgitation disappeared. One patient died of left ventricular diastolic dysfunction. All other patients left the hospital in New York Heart Association class I or II. CONCLUSIONS: We believe that this technique is preferable for patients with hypertrophic obstructive cardiomyopathy and diffuse hypertrophy extending to the midportion of the left ventricle or beyond. It results in disappearance of outflow tract gradients and allows correction of the mitral valve abnormality.

Functional impact of transmitral gradients at rest and during exercise after restrictive annuloplasty for ischemic mitral regurgitation.

OBJECTIVES: Restrictive mitral valve annuloplasty combined with coronary artery bypass grafting is the treatment of choice for ischemic mitral regurgitation. Postoperative functional mitral stenosis and its potential impact on functional capacity remain the object of debate. The aim of this study was to assess functional and hemodynamic outcome at rest and during exercise in a population with ischemic mitral regurgitation after a standardized restrictive mitral valve annuloplasty. METHODS: A total of 23 patients with ischemic mitral regurgitation who were previously treated with coronary artery bypass grafting and restrictive mitral valve annuloplasty underwent a semi-supine (bicycle) exercise test with Doppler echocardiography and ergospirometry. The surgical technique was identical in all patients, using a complete semi-rigid ring downsized by 2 sizes after measuring the height of the anterior mitral leaflet, to achieve a coaptation length of at least 8 mm. RESULTS: At a mean follow-up of 28 ± 15 months, mean transmitral gradients at rest and maximal exercise were 4.4 ± 1.8 mm Hg and 8.2 ± 4.2 mm Hg, respectively (P < .001). Transmitral gradients did not correlate with exercise capacity (maximal oxygen uptake) or pulmonary artery pressures. Patients with a resting mean gradient of 5 mm Hg or greater (n = 9) reached a significantly higher maximal oxygen uptake; however, they had a better ejection fraction and cardiac output at rest and reached a higher cardiac output at peak exercise. CONCLUSIONS: Transmitral gradients after restrictive mitral valve annuloplasty for ischemic mitral regurgitation did not correlate with functional capacity as measured by maximal oxygen uptake during semi-supine bicycle testing. Functional capacity and transmitral gradients are determined not only by the severity of mitral stenosis but also by hemodynamic factors, such as ejection fraction and cardiac output. Transmitral gradients should be interpreted with respect to patient hemodynamics and not necessarily be considered as detrimental for functional capacity.

Clinical outcomes after tricuspid valve annuloplasty in addition to mitral valve surgery.

Current guidelines recommend tricuspid valve annuloplasty (TVP) together with mitral valve surgery in cases of tricuspid annulus dilation (≥40 mm) or functional tricuspid valve regurgitation >2/4. Baseline clinical and echocardiographic data of patients undergoing mitral valve surgery in a single tertiary care hospital between 2007 and 2010 were analyzed. Mortality and heart failure hospitalization data were collected and groups with or without TVP were compared. Patients with TVP (n=89) had similar baseline characteristics compared with patients without (n=86), except for lower right ventricular fractional area change and more concomitant aortic valve surgery. Mortality was higher in the TVP group at 30 days (14% vs 5%; P=.04), but the difference was no longer significant at the end of follow-up. More patients were hospitalized for heart failure in the TVP group (31% vs 17%; hazard ratio, 2.1; 95% confidence interval, 1.1-4.0; P=.05). Right ventricular sphericity index was the only preoperative parameter predicting death or heart failure hospitalizations. In conclusion, patients undergoing TVP in addition to mitral valve surgery are at high risk for early death or subsequent heart failure hospitalizations, which might be partly explained by more complex heart disease. The extent of preoperative right ventricular remodeling may be predictive of adverse outcomes.

Salvage extensive coronary thromboendarterectomy for a ruptured left anterior descending artery.

We describe a lifesaving emergent thromboendarterectomy of the entire left anterior descending artery in a 63-year old man. Four days earlier, he had undergone a coronary artery bypass grafting. The left anterior descending artery was not bypassed then due to severe diffuse disease and calcifications. After an uneventful recovery, syncope occurred during exercise. Emergency catheterization revealed patent grafts, but no flow over the left anterior descending artery. At rescue percutaneous coronary intervention, a perforation of the left anterior descending artery occurred, leading to cardiogenic shock. A successful thromboendarterectomy of the left anterior descending artery salvaged the patient's life.

Augmentation of the posterior leaflet of the mitral valve.

The augmentation of mitral valve leaflets is mostly needed in rheumatic valve disease patients. The technical aspects of augmentation of the posterior leaflet by means of an autologous pericardial patch are described: the thickened and semi-rigid posterior leaflet is detached from the posterior annulus from commissure to commissure and augmented by an onlay patch of autologous pericardium which is incorporated using a continuous stitch-locked at each step-of Prolene or Pronova 5/0. The pitfall 'aortic cusp effect in diastole' is described as well as tips to prevent it.