Background: Transcatheter mitral valve-in-valve (TMVIV) procedure, either transapical (TA) or trans-septal (TS) has become a valuable alternative to conventional redo surgery in case of failing mitral bioprosthesis with good clinical outcomes. Here we present our fourteen-year institutional experience.Methods: All consecutive patients treated with TMVIV with either TA or TS access at our centre between July 2007 and July 2020 were included. Periprocedural and 30-day follow-up (FU) results are reported and TA and TS data are compared.Results: Eighty-two patients were included, of those 60 (73.2%) were TA while 22 (26.8%) were TS.Men represented 51.2% of the population with a mean age of 77.3±9.0 years. STS score and EuroSCORE II were 11.4%±6.2% and 11.5%±6.5% respectively. Baseline characteristics of TA and TS groups were comparable. TMVIV was performed at a median time of 9.3 years [interquartile range (IQR), 7.9-12.0 days] from the initial mitral valve surgery. Balloon expandable transcatheter heart valve (THV) prostheses (Edwards LifeSciences Corp., Irvine, CA, USA) were used exclusively. Technical success was 97.6% (96.7% and 100.0% for TA and TS respectively) with two (2.4%) periprocedural death, both in the TA group (P=0.533). We observed four (4.9%) left ventricular outflow tract (LVOT) obstructions with one being hemodynamically significant. Six (7.3%) major bleeding occurred in the TA group, not significantly different from TS group (P=0.279). The median length of stay was 6 days (IQR, 4-12 days, 1.5 vs. 7.0 days for TS and TA groups respectively, P=0.001). The overall 30-day mortality rate was 3.7%. We also observed three (3.7%) structural valve deteriorations and in one (1.2%) case the patient required redo mitral surgery at two months.Eighty-seven-point-eight percent of patients were I-II New York Heart Association (NYHA) class. At 30day FU mean transmitral valve gradient was 7.3±2.7 mmHg and one patient (1.2%) had mitral regurgitation greater than mild. TA and TS groups were comparable.Conclusions: Our 14-year single-center experience with TMVIV confirms procedural safety and is an effective alternative to redo surgery with comparable results with both TA and TS. With device, technical improvements and increasing operators' experience, TS is the preferred option for TMVIV. However, in some highly selected patient, TA may still play an important role.
Background The prognostic impact of systematic revascularization of asymptomatic coronary artery stenosis before transcatheter aortic valve replacement (TAVR) is still debated Purpose The main objectives of this study were to evaluate the feasibility and the safety of a functional evaluation of coronary artery disease (CAD) followed by a selective ischemia-guided percutaneous coronary intervention (PCI) after TAVR. Methods This prospective, bi-centric, one-arm, open-label trial included patients with severe aortic stenosis (AS) eligible for TAVR and with significant CAD defined as one or more coronary stenosis ≥70%. Patients with left main stenosis ≥50%, proximal left anterior descending artery (LAD) stenosis ≥90% or > class 2 Canadian cardiovascular society angina pectoris were excluded. Coronary revascularization was not performed before TAVR and myocardial ischemia was evaluated by stress cardiac imaging one month after the procedure using Single-Photon Emission Computed Tomography Myocardial Perfusion Imaging or Stress Echocardiography using dobutamine infusion. The primary endpoint was the composite of all cause of death, stroke, major bleeding (Bleeding Academic Research Consortium (BARC) ≥3), major vascular complication (Valve Academic Research Consortium 2 criteria), myocardial infarction (MI) and hospitalization for cardiac causes at 6 months following TAVR. Results Between June 2016 and March 2019, 71 patients were included with a complete follow-up in 66 patients. The mean age was 84±5.2 years and the mean Euroscore was 13±8.6. Stress cardiac imaging could be achieved in 70% (n=46) of the patients and the main causes to not perform it were patient refusal or secondary impaired medical condition. Significant myocardial ischemia was observed in only 3 patients (4.5%), of whom 2 patients had successful PCI. The primary endpoint occurred at 6 months in 15 patients (23%) including death in 6 patients (9%), stroke in 3 patients (5%) and major bleedings in 3 patients (5%). Acute MI was observed in only 2 patients (3%) that had not-LAD proximal and severe coronary stenosis (≥90%). Hospital readmission (n=27, 41%) was mostly related to non-cardiac causes (n=18, 27%). Conclusions In patients scheduled to TAVR and with significant coronary disease, a strategy of selective ischemia-guided coronary revascularization after TAVR appears safe with a low rate of myocardial infarction and myocardial ischemia requiring revascularization during follow-up. However, the poor adherence of elderly patients to stress test could suggest to perform PCI of proximal and severe coronary lesions. Large-scale and randomized trials are warranted to validate this strategy. Funding Acknowledgement Type of funding source: None
Background Bridging of vitamin K antagonist (VKA) with heparin is usually not promoted during interventional or surgical procedures related to increased risk of bleeding and thrombotic events but this strategy has not been evaluated during TAVI. Purpose The aim of this study was to evaluate the rate of major bleeding and vascular complications after TAVI performed in patients with uninterrupted VKA. Methods From January 2016 to October 2017, consecutive patients who underwent TAVI with uninterrupted VKA (INR between 1.5 and 3.5) were prospectively included in a monocentric registry. TAVI were performed according to current guidelines and a 50UI/kg bolus of heparin was injected at the beginning of the procedure for all patients. Vascular and bleeding complications were assessed using the Valve Academic Research Consortium 2 (VARC2) and the Bleeding Academic Research Consortium (BARC) definitions at 30 day follow-up. Results A total of 88 patients were included with a median age of 84 years [81.8–87], 42% being female, the median STS score was 5.1 [4.1–7.5], the median CHADS2-VASc was 5.5 [5–6] and 60.2% had a chronic kidney failure. Median INR at time of implantation was at 2.1 [1.8–2.6]. VKA were used for atrial fibrillation (89.8%), mechanic mitral prosthesis (5.7%) or venous thromboembolic disease (4.5%). Trans femoral access was used in 88.6% of the patients. Major bleeding (BARC ≥3b) occurred in 5 patients (5,7%) and major vascular complications occurred in 7 patients (8%). Peripheral arterial disease (RR = 10.95; 95% CI: 1.63 to 73.75; p=0.014) and carotid access (RR=8.56; 95% CI: 1.19 to 61.51; p=0.033) were significantly associated with major bleeding. INR >2.5 was significantly associated with vascular complications (RR=7.14; 95% CI: 1.29 to 39.63; p=0.025). In multivariate analysis, Body mass index (OR=1.26; 95% CI: 1.02 to 1.57; p=0.032) and INR >2.5 (OR=18.91; 95% CI: 1.62 to 221.26; p=0.010) were independent factor significantly associated with vascular complications or major bleeding. Mortality rate at 30 days follow-up was 2.3%, there was no myocardial infarction and stroke rate was 4.5%. Figure 1. Study flowchart Conclusion TAVI with uninterrupted VKA treatment seems to be feasible and safe with low risk of bleeding and vascular complications in this first single centre experience. Particular caution is advocated in low BMI patients and to keep INR<2.5.
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