Transapical mitral valve implantation for treatment of symptomatic mitral valve disease: a real-world multicentre experience.

AIMS: Transcatheter mitral valve implantation (TMVI) is a new treatment option for patients with symptomatic mitral valve (MV) disease. Real-world data have not yet been reported. This study aimed to assess procedural and 30-day outcomes of TMVI in a real-world patient cohort. METHOD AND RESULTS: All consecutive patients undergoing implantation of a transapically delivered self-expanding valve at 26 European centres from January 2020 to April 2021 were included in this retrospective observational registry. Among 108 surgical high-risk patients included (43% female, mean age 75 ± 7 years, mean STS-PROM 7.2 ± 5.3%), 25% was treated for an off-label indication (e.g. previous MV intervention or surgery, mitral stenosis, mitral annular calcification). Patients were highly symptomatic (New York Heart Association [NYHA] functional class III/IV in 86%) and mitral regurgitation (MR) was graded 3+/4+ in 95% (38% primary, 37% secondary, and 25% mixed aetiology). Technical success rate was 96%, and MR reduction to ≤1+ was achieved in all patients with successful implantation. There were two procedural deaths and 30-day all-cause mortality was 12%. At early clinical follow-up, MR reduction was sustained and there were significant reductions of pulmonary pressure (systolic pulmonary artery pressure 52 vs. 42 mmHg, p < 0.001), and tricuspid regurgitation severity (p = 0.013). Heart failure symptoms improved significantly (73% in NYHA class I/II, p < 0.001). Procedural success rate according to MVARC criteria was 80% and was not different in patients treated for an off-label indication (74% vs. 81% for off- vs. on-label, p = 0.41). CONCLUSION: In a real-world patient population, TMVI has a high technical and procedural success rate with efficient and durable MR reduction and symptomatic improvement.

Transcatheter Mitral Valve Replacement for Patients With Symptomatic Mitral Regurgitation: A Global Feasibility Trial.

BACKGROUND: Symptomatic mitral regurgitation (MR) is associated with high morbidity and mortality that can be ameliorated by surgical valve repair or replacement. Despite this, many patients with MR do not undergo surgery. Transcatheter mitral valve replacement (TMVR) may be an option for selected patients with severe MR. OBJECTIVES: This study aimed to examine the effectiveness and safety of TMVR in a cohort of patients with native valve MR who were at high risk for cardiac surgery. METHODS: Patients underwent transcatheter, transapical delivery of a self-expanding mitral valve prosthesis and were examined in a prospective registry for short-term and 30-day outcomes. RESULTS: Thirty patients (age 75.6 ± 9.2 years; 25 men) with grade 3 or 4 MR underwent TMVR. The MR etiology was secondary (n = 23), primary (n = 3), or mixed pathology (n = 4). The Society of Thoracic Surgeons Predicted Risk of Mortality was 7.3 ± 5.7%. Successful device implantation was achieved in 28 patients (93.3%). There were no acute deaths, strokes, or myocardial infarctions. One patient died 13 days after TMVR from hospital-acquired pneumonia. Prosthetic leaflet thrombosis was detected in 1 patient at follow-up and resolved after increased oral anticoagulation with warfarin. At 30 days, transthoracic echocardiography showed mild (1+) central MR in 1 patient, and no residual MR in the remaining 26 patients with valves in situ. The left ventricular end-diastolic volume index decreased (90.1 ± 28.2 ml/m2 at baseline vs. 72.1 ± 19.3 ml/m2 at follow-up; p = 0.0012), as did the left ventricular end-systolic volume index (48.4 ± 19.7 ml/m2 vs. 43.1 ± 16.2 ml/m2; p = 0.18). Seventy-five percent of the patients reported mild or no symptoms at follow-up (New York Heart Association functional class I or II). Successful device implantation free of cardiovascular mortality, stroke, and device malfunction at 30 days was 86.6%. CONCLUSIONS: TMVR is an effective and safe therapy for selected patients with symptomatic native MR. Further evaluation of TMVR using prostheses specifically designed for the mitral valve is warranted. This intervention may help address an unmet need in patients at high risk for surgery. (Early Feasibility Study of the Tendyne Mitral Valve System [Global Feasibility Study]; NCT02321514).

Long-term outcomes after transcatheter aortic valve implantation: the impact of intraoperative tissue Doppler echocardiography.

OBJECTIVES: Transcatheter aortic valve implantation improves survival in patients with severe aortic stenosis who are ineligible for surgical valve replacement; however, not all patients benefit from the procedure. We endeavoured to identify these patients using intraoperative echocardiography and hypothesized that intraoperative left ventricular function in response to the acute afterload reduction during the procedure was related to long-term outcomes. METHODS: We prospectively included 64 patients who were scheduled for transcatheter aortic valve implantation and divided them into responders and non-responders based on their left ventricular intraoperative responses to the acute afterload reduction after valve deployment. Responders were defined by increases of ≥20% in left ventricular longitudinal peak systolic velocities determined by tissue Doppler echocardiography. All patients were assessed for the following outcomes at 12 months: cardiac mortality, adverse cardiac events, quality of life, New York Heart Association class, N-terminal pro-brain natriuretic peptide (NT-proBNP) and echocardiography. RESULTS: Thirty-five patients (55%) were classified as responders and 29 patients (45%) as non-responders. Compared with responders, non-responders had higher risks of death (28 vs 9%, respectively, P = 0.04) and cardiac events (66 vs 26%, respectively, P < 0.01) during the 12-month follow-up. Significant long-term improvements in quality of life, NT-proBNP and left ventricular function were observed only in the responders. Preoperative risk stratification, intraoperative handling, aortic gradient and valve area were similar between groups. CONCLUSIONS: Intraoperative assessment of left ventricular function by tissue Doppler echocardiography predicted long-term outcomes after transcatheter aortic valve implantation. Our results suggest that a preoperative test of myocardial contractile reserve might improve risk stratification and patient selection prior to the procedure.

Transcatheter aortic valve implantation and intraoperative left ventricular function: a myocardial tissue Doppler imaging study.

OBJECTIVE: Transcatheter aortic valve implantation in patients turned down for surgical aortic valve replacement is a high-risk procedure. Severe aortic stenosis is associated with impaired left ventricular longitudinal motion, and myocardial peak systolic velocity is a measure of left ventricular function in these patients. The present study aimed to quantify the acute changes in left ventricular function during the procedure by using myocardial tissue Doppler imaging and transthoracic cardiac output measurements. DESIGN: Prospective observational study. SETTING: Tertiary care university hospital. PARTICIPANTS: 40 patients with severe aortic stenosis scheduled for transcatheter aortic valve implantation. INTERVENTIONS: Transesophageal 4-chamber and 2-chamber echocardiograms were performed immediately before and ~15 minutes after valve implantation. Longitudinal myocardial peak systolic velocity was obtained by tissue Doppler imaging from 8 basal segments and averaged. Cardiac output was measured by the lithium dilution method, and systemic vascular resistance index and stroke volume were calculated. MEASUREMENTS AND MAIN RESULTS: Longitudinal myocardial peak systolic velocity improved immediately after valve implantation, from -2.3±0.8 to -3.0±1.1 cm/sec (p<0.001); this represented an average increase of 31%±33%. Cardiac output increased from 3.2±0.8 L/min to 3.6±0.9 L/min (15%±33%; p = 0.04). This was due to increased heart rate (59±9 beats/min to 72±12 beats/min; p<0.001) and not to an improved stroke volume. Systemic vascular resistance index was reduced from 2,937±984 dynes*sec/cm(5)/m(2) to 2,436±730 dynes*sec/cm(5)/m(2) (p = 0.003). CONCLUSION: Intraoperative echocardiography tissue Doppler imaging detected immediate improvement in left ventricular long-axis motion after transcatheter aortic valve implantation. The method provided detailed information not obtainable by routine hemodynamic monitoring.

Cerebral ischemic injury and cognitive impairment after off-pump and on-pump coronary artery bypass grafting surgery.

BACKGROUND: Off-pump coronary artery bypass grafting surgery reduces the intraoperative cerebral embolic load and may therefore cause less brain injury. The main aim of this study was to compare off-pump and on-pump surgery with regard to the frequency of new postoperative cerebral ischemic lesions and the prevalence of postoperative cognitive impairment. We also assessed whether preoperative cerebral ischemic injury predicts the risk for cognitive dysfunction after surgery. METHODS: One hundred twenty patients with ischemic coronary artery disease were prospectively randomized to undergo off-pump or on-pump surgery. A detailed neuropsychological assessment and a cerebral magnetic resonance imaging examination were performed on the day before and at 3 months postoperatively. The neuropsychological assessment was repeated at 12 months. RESULTS: There was no significant (p = 0.17) difference between off-pump (8.2%) and on-pump (17.3%) surgery with regard to new postoperative cerebral lesions. The prevalence of cognitive impairment after surgery was also similar in the two groups (3 months: off-pump 20.4%, on-pump 23.1%, p = 0.74; 12 months: off-pump 24.1%, on-pump 23.1%, p = 0.90). The degree of preoperative cerebral ischemic injury was significantly associated with cognitive dysfunction after on-pump (p = 0.02) but not after off-pump (p = 0.22) surgery. None of the patients with normal preoperative radiologic findings were found to have cognitive impairment at 3 months postoperatively (p = 0.04). CONCLUSIONS: Long-term cognitive function and magnetic resonance imaging evidence of brain injury were similar after off-pump and on-pump coronary artery bypass grafting surgery. Preoperative cerebral magnetic resonance imaging can be used to predict the risk for cognitive dysfunction after coronary artery bypass grafting surgery.

Patient-reported outcome after randomization to on-pump versus off-pump coronary artery surgery.

BACKGROUND: Clinical experience with off-pump coronary artery bypass surgery raises the question of a patient experienced benefit compared with on-pump surgery. This prospective and randomized study compared patient-reported outcome between surgical groups, as change scores at 3 months after surgery and longitudinally as time-averaged change from baseline through the first year after surgery. METHODS: In all, 120 patients were randomly assigned to on- or off-pump coronary artery surgery. A questionnaire for patient self-report of angina (Canadian Cardiovascular Society scale), health status (Short Form 36, sleep and sexual difficulty), and overall quality of life (Quality of Life Scale) was administered at baseline and at 3, 6, and 12 months after surgery. RESULTS: Patient groups were comparable with regard to age, symptoms, comorbidity, and surgical characteristics. Both groups experienced a median of two classes relief of angina at 3 months (p < 0.0005), maintained throughout follow-up. Paired t tests revealed significant improvement on all Short Form 36 subscales at 3 months after surgery, with the exception of physical role functioning in the on-pump group. No independent main effects of surgical group were observed in the between-groups covariance models. The longitudinal effect of sex was significant in four Short Form 36 subscales: physical functioning, bodily pain, and role limitation due to physical or emotional problems. Overall quality of life scores were stable in both groups. CONCLUSIONS: Both on-pump and off-pump patients reported less angina and improved health status after surgery. There were no significant differences between surgical groups in health status or overall quality of life, neither cross-sectionally nor longitudinally.