Impact of pre-existing comorbidities on outcomes of patients undergoing surgical aortic valve replacement - rationale and design of the international IMPACT registry.

BACKGROUND: Degenerative aortic valve disease accounts for 10-20% of all cardiac surgical procedures. The impact of pre-existing comorbidities on the outcome of patients undergoing surgical aortic valve replacement (SAVR) needs further research. METHODS: The IMPACT registry is a non-interventional, prospective, open-label, multicenter, international registry with a follow-up of 5 years to assess the impact of pre-existing comorbidities of patients undergoing SAVR with the INSPIRIS RESILIA aortic valve on outcomes. IMPACT will be conducted across 25 sites in Austria, Germany, The Netherlands and Switzerland and intends to enroll approximately 500 patients. Patients will be included if they are at least 18 years of age and are scheduled to undergo SAVR with the INSPIRIS RESILIA Aortic Valve with or without concomitant ascending aortic root replacement and/or coronary bypass surgery. The primary objective is to determine all-cause mortality at 1, 3, and 5 years post SAVR. Secondary objectives include cardiac-related and valve-related mortality and structural valve deterioration including hemodynamics and durability, valve performance and further clinical outcomes in the overall study population and in specific patient subgroups characterized by the presence of chronic kidney disease, hypertension, metabolic syndrome and/or chronic inflammation. DISCUSSION: IMPACT is a prospective, multicenter European registry, which will provide much-needed data on the impact of pre-existing comorbidities on patient outcomes and prosthetic valve performance, and in particular the performance of the INSPIRIS RESILIA, in a real-world setting. The findings of this study may help to support and expand appropriate patient selection for treatment with bioprostheses. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT04053088 .

Automated Implantation of Artificial Mitral Chords: Preliminary Results From the Feasibility Trial.

PURPOSE: A novel chordal system enables automated implantation of artificial mitral chords to treat mitral regurgitation (MR). This article summarizes the first-in-man initial clinical results. DESCRIPTION: The CHAGALL (CHordArt system study for the treatment of mitral ReGurgitAtion due to leaflet proLapse or fLail) trial is a single arm, multicenter, prospective study to test the feasibility of this system for mitral repair. The interim clinical and echocardiographic results of the first 5 patients with a 12-month follow-up are presented. EVALUATION: Five patients (mean age, 64 years) with severe MR received implantation of neochords with this device under cardiopulmonary bypass. Technical success was obtained in all patients. Transesophageal echocardiogram showed either no or trace residual MR (<1+/4+) after repair. Survival at 30 days was 100%, and no device-related complication occurred. Reduction of MR was sustained up to 12 months. CONCLUSIONS: This novel chordal system is promising because it greatly facilitates the deployment of neochords to repair the mitral valve. Results at 12 months are encouraging. The device is currently under development for transcatheter approach.

Outcome of video-assisted thoracoscopic implantation of epicardial left ventricular leads with visual targeting for cardiac resynchronization therapy.

OBJECTIVES: Our goal was to analyse the implantation and outcome of thoracoscopic epicardial leads after a failed endovascular approach or follow-up (FU) complications after endovascular implantation. METHODS: We reviewed the records of patients with failed endovascular left ventricular (LV) lead placement or complications during FU, who were subsequently referred to cardiac surgeons for treatment with thoracoscopic LV lead implantation. We analysed the reasons for endovascular failure; the indications for the surgical procedures; and the clinical, echocardiographic and device FU results. RESULTS: Between 2010 and 2013, a total of 23 patients were included. Among them, 17 of the patients had no previous cardiothoracic surgery, 13 (76%) had successful video-assisted thoracoscopy (VAT) LV lead implantation, 3 (18%) had a conversion to thoracotomy and 1 (6%) failed. Of the 6 patients with prior cardiothoracic surgery, 2 (33%) had VAT only, 3 (50%) had primary thoracotomies and 1 (17%) had a conversion. Two major complications occurred. The reasons for LV endovascular lead failure were subclavian vein occlusion (n = 2), implant failure (n = 13) and complications during the FU period (n = 8). FU information was available for 20 patients: 17 (85%) had improved symptoms. The median FU period was 33 months. A total of 78% of patients were in New York Heart Association (NYHA) functional class III-IV before the operation; 30% were in NYHA functional class III-IV at the last FU examination. The left ventricular ejection fraction increased from 25% before surgery to 31% at the last FU examination. Overall, sensing and pacing threshold values remained stable over time. In 1 patient, lead revision was necessary due to an increase in the pacing threshold. CONCLUSIONS: VAT implantation of LV leads had an excellent response rate with an improvement in NYHA functional class and left ventricular ejection fraction. The lead measurements were mainly stable over time.

Single-center experience with the combination of Cardioplexol™ cardioplegia and MiECC for isolated coronary artery bypass graft procedures.

BACKGROUND: Cardioplexol™ with its low volume (100 mL) was originally conceived as cardioplegic solution for MiECC procedures. Introduced in its current form in 2008 in our clinic, it has immediately demonstrated attractive advantages including the easy and rapid administration by the surgeon him/herself, the almost immediate cardiac arrest and a prolonged delay before a second dose is necessary. We report here the results of our initial experience with this simple solution. METHODS: Single centre, retrospective observational analysis of prospectively collected data of isolated coronary artery bypass graft (CABG) procedures performed with a MiECC. RESULTS: Of 7,447 adult cardiac surgical operations performed during a 76 months period, 2,416 were isolated CABG-MiECC procedures. Patients were 81.3% males, 66.2±9.7 years old and had a median logistic EuroSCORE of 3.2. In average 3.2±0.8 vessels were bypassed. Median cross-clamp time was 45 minutes and more than 75% of the patients received only one 100 mL dose of Cardioplexol™. At reperfusion more than 90% of the hearts spontaneously recovered a rhythmic activity. Maximal value of troponin T during the first hours following myocardial reperfusion was 0.9±4.5 ng/mL (median =0.4 ng/mL). Mortality at 30 days was 0.9%. CONCLUSIONS: Cardioplexol™ seems very promising. It appears especially efficient and safe when used for CABG procedures performed with a MiECC.

Robotically Assisted Mitral Valve Repair as the Treatment of Choice for Patients with Difficult Anatomies.

Robotically assisted mitral valve repair has proven its efficacy during the last decade. The most suitable approach for patients with difficult anatomies, such as morbid obesity, sternal deformities, cardiac rotation, or vascular anomalies, represents a current challenge in cardiac surgery. Herein, we present the case of a 71-year-old patient affected by severe degenerative mitral valve regurgitation with pectus excavatum and a right aortic arch with an anomalous course of the left subclavian artery who was successfully treated using a Da Vinci-assisted approach.

Transcatheter or surgical repair for degenerative mitral regurgitation in elderly patients: A propensity-weighted analysis.

OBJECTIVE: To compare the outcomes of MitraClip and surgical mitral repair in low-intermediate risk elderly patients affected by degenerative mitral regurgitation (DMR). METHODS: We retrospectively selected patients aged ≥75 years, with Society of Thoracic Surgeons Predicted Risk Of Mortality (STS-PROM) <8%, submitted to MitraClip (n = 100) or isolated surgical repair (n = 206) for DMR at 2 centers between January 2005 and May 2017. To adjust for baseline imbalances, we used a propensity score model for average treatment effect on survival. RESULTS: After weighting, MitraClip showed fewer postoperative complications (P < .05) but increased residual mitral regurgitation (MR) ≥2 (27.0% vs 2.8%, P < .001) compared with surgery. One-year survival was greater after MitraClip compared with surgery (97.6% vs 95.3%, hazard ratio [HR], 0.09; confidence interval [CI], 0.02-0.37, P = .001), whereas 5-year survival was lower (34.5% vs 82.2% respectively, HR, 4.12; CI, 2.31-7.34, P < .001). Greater STS-PROM (HR, 1.18; CI, 1.12-1.24, P < .001) and MR ≥3+ recurrence (HR, 2.18; CI, 1.07-4.48, P = .033) were associated with reduced survival. 5-year MR ≥3+ was more frequent after MitraClip compared with surgery: 36.9% versus 3.9%, odds ratio, 11.4; CI, 4.40-29.68, P < .001. CONCLUSIONS: In elderly patients affected by DMR and STS-PROM <8%, the average effect of MitraClip resulted in lower acute postoperative complications and improved 1-year survival compared with surgery. However, MitraClip was associated with greater MR recurrence and reduced survival beyond 1 year. Long-term survival was impaired by patients' greater risk profile and MR recurrence. Early results are promising, but in the setting of operable patients with life expectancy beyond 1 year, the quality bar for transcatheter mitral repair needs to be raised.

Transcatheter aortic valve-in-ring implantation: feasibility in an acute, preclinical, pilot trial.

OBJECTIVES: The HAART ring device has been introduced as a novel strategy to facilitate aortic valve repair. This rigid, elliptical device aims to restore normal leaflet configuration and to provide annular stabilization in the setting of aortic regurgitation. The goal of this preclinical study is to evaluate the in vivo feasibility of 'aortic valve-in-ring' transcatheter aortic valve replacement (TAVR). METHODS: Six animals {landrace pigs, 87.6 [standard deviation (SD) 4.5] kg} underwent HAART ring implantation (5 cases #19 mm and 1 case #21 mm) via full sternotomy with cardiopulmonary bypass. Seven transfemoral TAVR implantations were performed with the Medtronic EvolutR prosthesis to assess the sizing and outcome (5 cases #23 mm, 1 case #26 mm and 1 case #29 mm). RESULTS: TAVR implantation was successful in 6 of 7 attempts. Post-dilatation was performed in 1 case without damage of the ring or the valve. One embolization occurred due to oversizing (EvolutR valve 29 mm in HAART ring 19 mm). No clinically relevant postimplantation gradient [7.6 (SD 4.0) mmHg] or regurgitation was detected by invasive and echocardiographic measurements. Postoperative computed tomography scans revealed good device configuration. CONCLUSIONS: Transcatheter aortic valve-in-ring implantation of a self-expandable TAVR into a rigid aortic annuloplasty ring after aortic valve repair appears feasible. Proper sizing and correct depth of implantation are crucial.

Recent advances in understanding and managing aortic stenosis.

Over the last few years, treatment of severe symptomatic aortic stenosis in high-risk patients has drastically changed to adopt a less-invasive approach. Transcatheter aortic valve implantation (TAVI) has been developed as a very reproducible and safe procedure, as shown in many trials. When compared to surgery, TAVI has produced superior, or at least comparable, results, and thus a trend to broaden treatment indications to lower-risk patients has erupted as a natural consequence, even though there is a lack of long-term evidence. In this review, we summarize and underline aspects that still remain unanswered that are compulsory if we want to enhance our understanding of this disease.

Transcatheter mitral valve chord repair.

The field of mitral valve disease diagnosis and management is rapidly evolving. New understanding of pathophysiology and improvements in the adoption of sophisticated multimodality imaging modalities have led to early diagnosis and to more complex treatment. The most common cause of mitral regurgitation (MR) in the western world is in the primary alteration of the valve, which leads to degenerative leaflet prolapse due to chordal elongation or rupture and annular dilatation. Untreated, significant MR has a negative impact prognosis, leading to reduction of survival. In the setting of degenerative MR, surgical repair currently represents the standard of care. Treatment of asymptomatic patients with severe MR in the Valve Center of Excellence, in which successful repair reaches more than 95% and surgical mortality less than 1%, symbolizes the direction for the next years. Transcatheter mitral valve repair with different devices, more recently the chordal replacement ones, is providing good outcomes and became a therapeutic option in high-risk patients with degenerative MR. In the future, more advances are expected from further development of interventional techniques, careful evaluation and better patient selection. This review will focus on long-term surgical outcomes of mitral valve repair with artificial chordae and on the emerging transcatheter chordal repair devices as therapeutic options for degenerative MR patients.

Transvalvular pressure gradients for different methods of mitral valve repair: only neochordoplasty achieves native valve gradients.

OBJECTIVES: Many surgical and interventional methods are available to restore patency for patients with degenerative severe mitral valve regurgitation. Leaflet resection and neochordoplasty, which both include ring annuloplasty, are the most frequently performed techniques for the repair of posterior mitral leaflet flail. It is unclear which technique results in the best haemodynamics. In this study, we investigated the effect of different mitral valve reconstruction techniques on mitral valve haemodynamics and diastolic transvalvular pressure gradient in an ex vivo porcine model. METHODS: Eight porcine mitral valves were tested under pulsatile flow conditions in an in vitro pulsatile flow loop for haemodynamic quantification. Severe acute posterior mitral leaflet flail was created by resecting the posterior marginal chorda. The acute mitral valve regurgitation was corrected using 4 different repair techniques, in each valve, in a strictly successive order: (i) neochordoplasty with polytetrafluoroethylene sutures alone and (ii) with ring annuloplasty, (iii) edge-to-edge repair and (iv) triangular leaflet resection, both with ring annuloplasty. Valve haemodynamics were measured and quantified for all valve configurations (native, rupture and each surgical reconstruction). The results were analysed using a validated statistical linear mixed model, and the P-values were calculated using a 2-sided Wald test. RESULTS: All surgical reconstruction techniques were able to sufficiently correct the acute mitral valve regurgitation. Neochordoplasty without ring annuloplasty was the only reconstruction technique that resulted in haemodynamic properties similar to the native mitral valve (P-values from 0.071 to 0.901). The diastolic transvalvular gradient remained within the physiological range for all reconstructions but was significantly higher than in the native valve for neochordoplasty with ring annuloplasty (P < 0.000), edge-to-edge repair (P < 0.000) and leaflet resection (P < 0.000). Neochordoplasty without ring annuloplasty resulted in a significantly better pressure gradient than neochordoplasty with a ring annuloplasty (P < 0.000). Additionally, neochordoplasty with a ring annuloplasty resulted in significantly lower transvalvular pressure gradients than edge-to-edge repair (P < 0.000) and leaflet resection (P < 0.000). CONCLUSIONS: Neochordoplasty with or without ring annuloplasty was the reconstruction technique that almost achieved native physiological haemodynamics after repair of posterior mitral leaflet flail after acute isolated chordal rupture in our ex vivo porcine model.

Long-Term Outcomes after Minimally Invasive Aortic Valve Surgery through Right Anterior Minithoracotomy.

Background Minimally invasive aortic valve surgery (MIAV) through a right anterior minithoracotomy evolved to an accepted procedure with favorable short- and mid-term outcomes, whereas long-term results lack. The aim of this study was to evaluate the long-term outcomes. Materials and Methods All our MIAV patients were included (n = 225). Mean age was 68 ± 12 years, 29% were older than 75 years, and median EuroSCORE was 5 (0-11). Baseline characteristics, inhospital outcomes, and follow-up information about survival, major adverse cardiac and cerebrovascular events (MACCE), and need for reoperation were collected and analyzed. Results In this study, 30-day mortality was 1.3%, and there was no permanent stroke. Mean follow-up time was 69.65 ± 24 months, being the longest so far reported in the literature. At 1 and 7 years, survival was 95.8 and 79%, freedom from MACCE 98.1 and 95.7%, and from reoperation 99.5 and 98.7%, respectively. Conclusion MIAV is safe and feasible with favorable long-term outcomes. In the future, it could serve as benchmark for interventional methods as soon as indications are expanded to young and low-risk patients. Randomized studies are needed to compare the long-term outcomes of these approaches.

Selective, segmental decalcification: a safe alternative to extensive debridement of a severely calcified annulus during repair of mitral regurgitation.

Resection of the calcium bar and creation of a more compressible annulus with pericardium are necessary in case of extensive calcification of the mitral valve annulus in patients with advanced myxomatous degenerative disease. Such annular bar calcification is technically challenging and represents a risk factor for death following mitral valve operations, because of atrio-ventricular rupture or encroachment of the coronary arteries. We describe a safe limited segmental annular debridement away from the coronary arteries that allows enough flexibility of the remaining calcified annulus to perform reduction annuloplasty in a young female patient with severe mitral regurgitation and a highly dilated and severely calcified mitral annulus.

Treatment of isolated ascending aortic aneurysm by off-pump epiaortic wrapping is safe and durable.

OBJECTIVES: Isolated ascending aortic aneurysm (iAA) is usually treated by open graft repair requiring sternotomy, cardiopulmonary bypass (CPB) and cardioplegia. This approach carries significant mortality in older patients or those presenting with comorbidities. We report an original series of patients presenting with iAA and treated with epiaortic wrapping by using a synthetic mesh. This less invasive aortic repair technique allows reducing the aortic diameter to a predefined value and is performed without CPB. METHODS: Data from patients presenting with an iAA and treated with the wrapping technique (WT) by polypropylene/polyester mesh from November 2006 to July 2015 were collected. The end-points that were analysed included maximal aortic transverse diameter, perioperative mortality and morbidity, survival, freedom from reinterventions and aortic valve function during follow-up. The maximal aneurysm transverse diameter was analysed based on contrast-enhanced computed tomography (CTA) or magnetic resonance (MR) performed preoperatively, and during the follow-up. RESULTS: The off-pump WT was used in 33 cases with no perioperative mortality. The median radiological follow-up was 33.47 (range: 1-106) months. Overall, the WT achieved a 30% diameter reduction. The mean preoperative and postoperative ascending aortic transverse diameter was 5.5 cm [standard deviation (SD): 0.6] and 3.7 cm (SD: 0.30), respectively (P = 0.001). In addition, CTA or MR follow-up showed stable diameters at the level of the aortic root and the distal ascending aorta. No death occurred during the follow-up. At 5 years, the estimated freedom rate from reinterventions of the aortic root and ascending aorta was 94%. CONCLUSIONS: This series shows that the WT with a polypropylene/polyester mesh allows safe off-pump treatment of patients with iAA. Mid- and long-term results are promising. This technique could be an attractive alternative, especially for patients unfit for aortic surgery with CPB and cardioplegia.