Transcatheter aortic valve implantation versus sutureless aortic valve replacement: a single-centre cost analysis.

AIMS: Sutureless aortic valve replacement (SU-AVR) and transcatheter aortic valve implantation (TAVI) are both viable therapeutic interventions for aortic stenosis in elderly patients. Meta-analyses show similar all-cause mortality for both techniques albeit with a different pattern of adverse effects. This study means to compare costs and, to a lesser extent, clinical outcomes of both techniques. METHODS: A retrospective single-centre analysis was performed for patients receiving SU-AVR or TAVI from 2008 to 2019. Perioperative clinical data were collected from patient files. Costs were assessed by a cost allocation tool. In an attempt to avoid confounding, propensity score matching was carried out. RESULTS: A total of 368 patients underwent either TAVI (n = 100) or SU-AVR (n = 268). After matching, there were 61 patients per treatment group. Length of stay was significantly longer in the SU-AVR group. Excluding device costs, total expenses for SU-AVR (median: €11,630) were significantly higher than TAVI (median: €9240). For both groups, these costs were mostly incurred on intensive care units, followed by nursing units. Non-medical staff was the largest contributor to expenses. Including device costs, SU-AVR (median: €14,683) was shown to be cost-saving compared to TAVI (median: €24,057). CONCLUSIONS: To conclude, we found SU-AVR to be cost-saving compared to TAVI, largely due to higher device costs associated with the latter. Excluding device costs, TAVI was associated with lower expenses and shorter length of stay. Non-medical staff was the largest source of costs, suggesting length of stay to be a major financial determinant.

In vivo performance of a tri-leaflet mechanical heart valve prosthesis in an ovine model.

OBJECTIVES: We present the long-term results of a trileaflet (Triflo) versus bileaflet (On-X) mechanical valve in both aortic and pulmonary positions in a sheep model. METHODS: The Triflo valve was implanted in 21 female sheep in aortic (n = 8) and pulmonary position (n = 13). The On-X valve was implanted in 7 female sheep in aortic (n = 1) and pulmonary (n = 6) positions. No antithrombotic medication of any kind was given postoperatively. In the aortic group, survival cohorts were 3 and 5 months. In the pulmonary group, survival cohorts were 10 and 20 weeks. Valve performance was assessed using haematology, echocardiography and acoustic measurements combined with post-mortem pathology analysis of the downstream organs. RESULTS: The mean gradients were lower for the Triflo valve in both pulmonary [4.30 mmHg (3.70-5.73) vs 6.80 mmHg (4.63-7.96), P = 0.012] and aortic [5.1 mmHg (4.2-7.7) vs 10.7 mmHg (8.7-12.9), P = 0.007] positions. Peak gradients were lower for the Triflo valve in both pulmonary [8.05 mmHg (6.75-10.23) vs 13.15 mmHg (9.20-14.76), P = 0.005] and aortic [8.7 mmHg (7.5-12.5) vs 16.5 mmHg (14.2-19.6), P = 0.009] positions. In both positions, leaflets and housing surface were free from any deposits macro- and microscopically and comparable to nonimplanted control valves. Peripheral organs showed no signs of thrombo-embolic damage. Biochemical and haematological were comparable to preoperative. The closing click sound pressure level of the Triflo was significantly lower in both aortic [108.4 sound pressure level (102.0-115.7) vs 111.7 sound pressure level (105.5-117.0), P < 0.001] and pulmonary [103.6 sound pressure level (99.1-108.9) vs 118.5 sound pressure level (116.7-120.2), P < 0.001] position. CONCLUSIONS: Preliminary in vivo results of the Triflo valve are promising in both aortic and pulmonary positions in an ovine model. Excellent haemodynamics, stable long-term function, low valve noise and no thrombo-embolic events in the absence of antithrombotic medication lay the foundation to a future clinical first-in-man trial.

Matched comparison between external aortic root support and valve-sparing root replacement.

OBJECTIVES: Differences in indication and technique make a randomised comparison between valve-sparing root replacement (VSRR) and personalised external aortic root support (PEARS) challenging. We performed a propensity score (PS)-matched comparison of PEARS and VSRR for syndromic root aneurysm. METHODS: Patients in the PEARS 200 Database and Aortic Valve Insufficiency and ascending aorta Aneurysm InternATiOnal Registry (undergoing VSRR) with connective tissue disease operated electively for root aneurysm <60 mm with aortic regurgitation (AR) <1/4 were included. Using a PS analysis, 80 patients in each cohort were matched. Survival, freedom from reintervention and from AR ≥2/4 were estimated using a Kaplan-Meier analysis. RESULTS: Median follow-up was 25 and 55 months for 159 PEARS and 142 VSRR patients. Seven (4.4%) patients undergoing PEARS required an intervention for coronary injury or impingement, resulting in one death (0.6%). After VSRR, there were no early deaths, 10 (7%) reinterventions for bleeding and 1 coronary intervention. Survival for matched cohorts at 5 years was similar (PEARS 98% vs VSRR 99%, p=0.99). There was no difference in freedom from valve or ascending aortic/arch reintervention between matched groups. Freedom from AR ≥2/4 at 5 years in the matched cohorts was 97% for PEARS vs 92% for VSRR (p=0.55). There were no type A dissections. CONCLUSIONS: VSRR and PEARS offer favourable mid-term survival, freedom from reintervention and preservation of valve function. Both treatments deserve their place in the surgical repertoire, depending on a patient's disease stage. This study is limited by its retrospective nature and different follow-ups in both cohorts.

Sutureless aortic valves in isolated and combined procedures: Thirteen years of experience in 784 patients.

OBJECTIVE: The aim of this study was to evaluate the outcome and experience of the Perceval sutureless valve at our institution (UZ Leuven). METHODS: Between 2007 and 2019, 784 patients underwent sutureless aortic valve replacement using the Perceval valve (isolated or combined with other procedures). We performed a retrospective analysis of the postoperative and follow-up data. RESULTS: Mean age was 78 years with a median European System for Cardiac Operative Risk Evaluation II score of 4.2% (interquartile range, 2.6%-7.2%). Isolated aortic valve replacement accounted for 45% of cases; 30% of cases were aortic valve replacement in combination with coronary artery bypass grafting and the remaining 25% were other combined procedures. The median crossclamp times were 38 minutes in single aortic valve replacement, 70 minutes in cases with coronary artery bypass grafting, and 89 minutes in multiple valve cases. Device success was 99.1% and in-hospital mortality was 3.3%. Postoperative stroke or transient ischemic attack occurred in 1.9% of patients and 1% of patients had a new need for dialysis after surgery and median survival time was 7.0 years with a cumulative follow-up of 2797.8 patient-years. The 1-, 5-, and 10-year freedom from reintervention were 99%, 97%, and 94%, respectively. CONCLUSIONS: These data represent the longest follow-up available, to our knowledge, for the Perceval sutureless valve. We observed favorable early outcomes, and low rates of early mortality, stroke, and other major complications. Valve durability is promising with low rates of valve degeneration and a limited need for reintervention.

Avoiding oversizing in sutureless valves leads to lower transvalvular gradients and less permanent pacemaker implants postoperatively.

OBJECTIVES: The aim of this study was to evaluate the impact of changing the sizing strategy in aortic valve replacement using the Perceval sutureless prosthesis on haemodynamic outcomes and postoperative pacemaker implantation. METHODS: Retrospective analysis of patients implanted with the Perceval valve between 2007 and 2019 was performed by comparing patients implanted before the modification of sizing strategy (OLD group) and after (NEW group). The outcome parameters evaluated were the implanted prosthesis size, haemodynamical profile and postoperative pacemaker implantation. RESULTS: The entire patient cohort (784 patients) consisted of 52% female patients, with a mean age of 78.53 [standard deviation (SD): 5.8] years and a mean EuroSCORE II of 6.3 (range 0.7-76). In 55.5% of cases, surgery was combined. The NEW cohort had more male patients (54.6% vs 43.4%) (P = 0.002). Mean implanted valve size, corrected for body surface area, was significantly lower in the NEW cohort (13.1, SD: 1.4 vs 13.5, SD: 1.4 mm/m2, P < 0.001). The 30-day mortality was 3.4%. Peak and mean transvalvular gradients at discharge were significantly lower in the NEW versus OLD groups: 24.4 mmHg (SD: 9.2) versus 28.4 mmHg (SD: 10.3) (P < 0.001) and 13.6 mmHg (SD: 5.3) versus 15.5 mmHg (SD: 6.0) (P < 0.001). The mean effective opening area and the indexed effective opening area, respectively, increased from 1.5 cm2 (SD: 0.5) and 0.85 cm2/m2 (SD: 0.27) in the OLD group to 1.7 cm2 (SD: 0.5) and 0.93 cm2/m2 (SD: 0.30) in the NEW group (P < 0.001). No difference was found in paravalvular leakage ≥1/4. Centrovalvular leakage ≥1/4 significantly decreased from 18% to 7.9% (P < 0.001). With the new sizing, the new postoperative pacemaker implantation rate decreased significantly from 11% to 6.1% (P = 0.016). CONCLUSIONS: Correct sizing of sutureless aortic valves is crucial to obtain the best possible haemodynamics and avoid complications.

Antithrombotic Treatment After Surgical and Transcatheter Heart Valve Repair and Replacement.

New antithrombotic drugs have been developed, new valve types have been designed and minimally invasive transcatheter techniques have emerged, making the choice of antithrombotic therapy after surgical or transcatheter heart valve repair and replacement increasingly complex. Moreover, due to a lack of large randomized controlled trials many recommendations for antithrombotic therapy are based on expert opinion, reflected by divergent recommendations in current guidelines. Therefore, decision-making in clinical practice regarding antithrombotic therapy for prosthetic heart valves is difficult, potentially resulting in sub-optimal patient treatment. This article compares the 2017 ESC/EACTS and 2020 ACC/AHA guidelines on the management of valvular heart disease and summarizes the available evidence. Finally, we established a convenient consensus on antithrombotic therapy after valve interventions based on over 800 annual cases of surgical and transcatheter heart valve repair and replacement and a multidisciplinary team discussion between the department of cardiovascular diseases and cardiac surgery of the University Hospitals Leuven, Belgium.

Remote Heart Rhythm Monitoring by Photoplethysmography-Based Smartphone Technology After Cardiac Surgery: Prospective Observational Study.

BACKGROUND: Atrial fibrillation (AF) is the most common arrhythmia after cardiac surgery, yet the precise incidence and significance of arrhythmias after discharge home need to be better defined. Photoplethysmography (PPG)-based smartphone apps are promising tools to enable early detection and follow-up of arrhythmias. OBJECTIVE: By using a PPG-based smartphone app, we aimed to gain more insight into the prevalence of AF and other rhythm-related complications upon discharge home after cardiac surgery and evaluate the implementation of this app into routine clinical care. METHODS: In this prospective, single-center trial, patients recovering from cardiac surgery were asked to register their heart rhythm 3 times daily using a Food and Drug Administration-approved PPG-based app, for either 30 or 60 days after discharge home. Patients with permanent AF or a permanent pacemaker were excluded. RESULTS: We included 24 patients (mean age 60.2 years, SD 12 years; 15/23, 65% male) who underwent coronary artery bypass grafting and/or valve surgery. During hospitalization, 39% (9/23) experienced postoperative AF. After discharge, the PPG app reported AF or atrial flutter in 5 patients. While the app notified flutter in 1 patient, this was a false positive, as electrocardiogram revealed a 2nd-degree, 2:1 atrioventricular block necessitating a permanent pacemaker. AF was confirmed in 4 patients (4/23, 17%) and interestingly, was associated with an underlying postoperative complication in 2 participants (pneumonia n=1, pericardial tamponade n=1). A significant increase in the proportion of measurements indicating sinus rhythm was observed when comparing the first to the second month of follow-up (P<.001). In the second month of follow-up, compliance was significantly lower with 2.2 (SD 0.7) measurements per day versus 3.0 (SD 0.8) measurements per day in the first month (P=.002). The majority of participants (17/23, 74%), as well as the surveyed primary care physicians, experienced positive value by using the app as they felt more involved in the postoperative rehabilitation. CONCLUSIONS: Implementation of smartphone-based PPG technology enables detection of AF and other rhythm-related complications after cardiac surgery. An association between AF detection and an underlying complication was found in 2 patients. Therefore, smartphone-based PPG technology may supplement rehabilitation after cardiac surgery by acting as a sentinel for underlying complications, rhythm-related or otherwise.

Influence of Tissue Technology on Pannus Formation on Bioprosthetic Heart Valves.

PURPOSE: Bioprosthetic heart valves have several modes of failure. Tissue degeneration and calcification are the major modes of failure with the highest focus of attention, however pannus formation can also be problematic. We studied the effect of a new tissue technology with the absence of any glutaraldehyde-based storage solution and a stable aldehyde capping process on pannus formation. METHODS: Using a juvenile sheep model of mitral valve replacement, valves with the new tissue technology were compared to control valves with contemporary bovine pericardial tissue, regarding pannus formation. Valves were implanted for either a 5- or 8-month period. Explanted valves were examined macroscopically and histologically. Histological observations were made by an independent pathologist, blinded to group identity. RESULTS: Pannus area measured macroscopically on the test valves was significantly lower than the pannus on the control tissue. This was confirmed on the histological samples, where the total pannus overgrowth was significantly lower in the test group compared to the control. CONCLUSION: The new tissue technology leads to less pannus formation. This may beneficially influence both short- and long-term valve behavior of bioprosthetic valves.