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 .

Mitral valve repair with a device for artificial chordal implantation at 2 years.

Objectives: This study examines the early and midterm safety, efficacy, and durability of mitral valve repair for primary mitral regurgitation (MR) using the ChordArt device (CoreMedic) for chordal replacement. Methods: Five patients with symptomatic severe primary degenerative MR due to isolated central posterior leaflet prolapse/flail were treated with the ChordArt device in a transseptal surgical approach and followed prospectively with periodical clinical and echocardiographic assessments for 2 years. Results: Reduction of MR immediately after the implantation of artificial chords was achieved in all patients showing no or trace MR (<1+/4+). In all patients, MR <1+ was maintained during 24 months of follow-up. No dehiscence, detachment, or dislocation of the implanted ChordArt devices was observed. Transthoracic echocardiography showed that left ventricle end diastolic diameter significantly decreased during the whole follow-up period in comparison to baseline condition, especially at discharge and 1-month follow-up. Left ventricle end systolic diameter also significantly decreased during the whole follow-up period in comparison to baseline condition. Left atrial volume significantly decreased during the follow-up period in comparison to discharge. No major adverse events, as defined per protocol, were observed during the intervention or during the follow-up period. Conclusions: The ChordArt device allows successful treatment of primary degenerative MR due to posterior mitral leaflet prolapse or flail, with a good safety profile and promising immediate clinical and echocardiographic benefits that are confirmed up to 24 months.

Polyester Vascular Graft Material and Risk for Intracavitary Thoracic Vascular Graft Infection1.

Prosthetic vascular graft infections of the thoracic aorta are rare but can be fatal. Our comparison of collagen- and gelatin-coated grafts showed that collagen-coated grafts were associated with increased biofilm formation and bacterial adherence in vitro and with higher rates of perioperative vascular graft infections in vivo.

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.

Rivaroxaban in patients with mechanical heart valves: A pilot study.

BACKGROUND: Patients with mechanical heart valves are still not eligible for treatment with direct oral anticoagulants (DOAC). We aimed to conduct a proof-of-principle study investigating the anti-Xa inhibitor rivaroxaban as antithrombotic treatment in patients with recent mechanical aortic valve replacement. MATERIALS AND METHODS: Low-risk patients scheduled for elective mechanical aortic valve replacement were treated with rivaroxaban 20 mg once daily (OD) in a prospective cohort study, started on day 3 postoperatively and given for 6 months. The study was registered at ClinicalTrials.gov (#NCT02128841). RESULTS: Ten patients were included (median age, 48; range 39 to 60). Indication was aortic valve stenosis in 6 patients, aortic root aneurysm with severe aortic valve regurgitation in 3 patients, and mixed stenosis/regurgitation in 1 patient. Neither thromboembolic nor bleeding events were observed, and no patient died. Absence of valve thrombosis was demonstrated in all patients. On day 7, median D-dimers were 2723 µg/L (inter-quartile range [IQR] 1672, 5695 µg/L), median TAT levels were 4.5 µg/L (IQR 4.1, 5.6 µg/L); and median peak thrombin generation was 150 nM (IQR 91, 183). On day 90, median D-dimers were 426 µg/L (IQR 278, 569), median TAT levels were 2.7 µg/L (IQR 2.2, 3.1), and median peak thrombin generation were 66 nM (IQR 62, 87). CONCLUSIONS: Rivaroxaban 20 mg OD was safe and effective in a pilot study of 10 low risk patients with mechanical aortic heart valve. Our results justify larger studies investigating the application of anti-Xa inhibitors in patients with mechanical heart valves.

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.

Outcome of inter-hospital transfer of patients on extracorporeal membrane oxygenation in Switzerland.

AIMS OF THE STUDY: An extracorporeal membrane oxygenation system (ECMO), as a bridge to either recovery, a ventricular assist device (VAD), or heart or lung transplantation, may be the only lifesaving option for critically ill patients suffering from refractory cardiac, respiratory or combined cardiopulmonary failure. As peripheral hospitals may not offer ECMO treatment, tertiary care centres provide specialised ECMO teams for on-site implantation and subsequent patient transfer on ECMO to the tertiary hospital. This study reports the results of the largest ECMO transportation programme in Switzerland and describes its feasibility and safety. METHODS: Patients transported on ECMO by our mobile ECMO team to our tertiary centre between 1 September 2009 and 31 December, 2016 underwent retrospective analysis. Implantation was performed by our specialised ECMO team (primary transport) or by the medical staff of the referring hospital (secondary transport) with subsequent transfer to our institution. Type of ECMO, transport data, patient baseline characteristics, operative variables and postoperative outcomes including complications and mortality were collected from medical records. RESULTS: Fifty-eight patients were included (three patients excluded: one repatriation, two with incomplete medical records). Thirty-five patients (60%) received veno-venous, 22 (38%) veno-arterial and one patient (2%) veno-venoarterial ECMO. Forty-nine (84%) patients underwent primary and nine (16%) secondary transport. Thirty-five (60%) patients were transferred by helicopter and 23 (40%) by ambulance, with median distances of 38.1 (13–225) km and 21 (3-71) km respectively. No clinical or technical complications occurred during transportation. During hospitalisation, three patients had ECMO-associated complications (two compartment syndrome of lower limb, one haemothorax after central ECMO upgrade). Median days on ECMO was 8 (<1–49) and median days in hospital was 17 (<1–122). ECMO weaning was successful in 41 patients (71%), on-transport survival was 100%, 40 patients survived to discharge (69%), and overall survival was 67% (39 patients) at a median follow-up of 58 days (<1–1441). Cumulative survival was significantly affected by cardiogenic shock vs. ARDS (p = 0.001), veno-arterial and veno-venoarterial vs. veno-venous ECMO (p = 0.001) and after secondary vs. primary transport (p <0.001). The ECMO weaning rate was significantly lower after secondary transfer (22%, two patients, both vaECMO) vs. primary transfer (80%, p = 0.002, 39 patients of which 35 (71%) had vvECMO). CONCLUSIONS: The first results of our ECMO transportation programme show its feasibility, safety and efficacy without on-site implant or on-transport complications or mortality. The favourable early survival may justify the large effort with respect to logistics, costs and manpower. With rising awareness, referring centres may increasingly consider this lifesaving option at an early stage, which may further improve outcomes.

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.

The role of FDG PET/CT in therapy control of aortic graft infection.

PURPOSE: 18F-FDG PET/CT (PET/CT) is a useful tool for the diagnosis of aortic graft infection (AGI), but has rarely been used to influence therapeutic decisions during follow-up. We aimed to study the role of PET/CT in the long-term monitoring of patients. METHODS: Participants of the prospective Vascular Graft Infection Cohort Study (VASGRA) were included if they had microbiologically proven AGI. We quantified the metabolic activity in PET/CT by using maximum standardized uptake value (SUVmax) and further classified it as being focal or diffuse. Multivariable linear regression models were fit using generalized estimating equations to investigate factors associated with SUVmax over time. RESULTS: Sixty-eight participants with AGI contributed to 266 PET/CTs including 36 examinations performed after stop of antimicrobial therapy. Higher C-reactive protein (CRP) (adjusted coefficient per log10 mg/L 0.05 [95% C.I. 0.02-0.08]) was associated with higher SUVmax. CRP, metabolic and clinical findings informed the decision to either start (medians of SUVmax 7.1 and CRP 31.5 mg/L; 100% focal uptake), escalate (SUVmax 9.5; CRP 31.5; 100% focal uptake), continue (SUVmax 6.0; CRP 9.95 mg/L; 90% focal uptake), or stop (SUVmax 4.3; CRP 3.5 mg/L; 61% focal uptake) antibiotic treatment. Of note, decisions to escalate or continue antibiotic treatment were taken despite normal CRP values in 12.5 and 35.7% of PET/CTs, respectively. CONCLUSIONS: Consecutive PET/CTs could influence the clinical decision-making in patients with AGI in the near future. More studies on the use of PET/CT in case of aortic graft infection may offer the potential for individualized treatment approaches. CLINICALTRIALS. GOV IDENTIFIER: NCT01821664.

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.