2-year outcomes of MitraClip as a bridge to heart transplantation: The international MitraBridge registry.

BACKGROUND: In the first report from the MitraBridge registry, MitraClip as a bridge to heart transplantation (HTx) proved to be at 1-year an effective treatment strategy for 119 patients with advanced heart failure (HF) who were potential candidates for HTx. We aimed to determine if benefits of MitraClip procedure as a bridge-to-transplant persist up to 2-years. METHODS: By the end of the enrollment period, a total of 153 advanced HF patients (median age 59 years, left ventricular ejection fraction 26.9 ± 7.7%) with significant secondary mitral regurgitation, who were potential candidates for HTx and were treated with MitraClip as a bridge-to-transplant strategy, were included in the MitraBridge registry. The primary endpoint was the 2-year composite adverse events rate of all-cause death, first hospitalization for HF, urgent HTx or LVAD implantation. RESULTS: Procedural success was achieved in 89.5% of cases. Thirty-day mortality was 0%. At 2-year, Kaplan-Meier estimates of freedom from primary endpoint was 47%. Through 24 months, the annualized rate of HF rehospitalization per patient-year was 44%. After an overall median follow-up time of 26 (9-52) months, elective HTx was successfully performed in 30 cases (21%), 19 patients (13.5%) maintained or obtained the eligibility for transplant, and 32 patients (22.5%) no longer had an indication for HTx because of significant clinical improvement. CONCLUSIONS: After 2-years of follow-up, the use of MitraClip as a bridge-to-transplant was confirmed as an effective strategy, allowing elective HTx or eligibility for transplant in one third of patients, and no more need for transplantation in 22.5% of cases.

Long-term echocardiographic findings after TAVR: 5-year follow-up in 400 consecutive patients.

A little is known about long-term hemodynamic performance of the transcatheter heart valves (THVs). The aim of the present study was to assess hemodynamic outcome, structural valve deterioration (SVD) and bioprosthetic valve failure (BVF) in patients treated with transcatheter aortic valve replacement (TAVR) five or more years ago. All consecutive patients treated at Bologna and Florence University Hospitals with TAVR between January 2008 and December 2013 were analyzed in a retrospective registry with regards to demographic, procedural and outcome data as well as follow-up data on mortality and echocardiographic characteristics. Standardized definitions were used to define outcomes and durability of the THVs. 400 patients were included in the study, mostly treated with transfemoral TAVR (71.8%), using first generation balloon-expandable (37%) or self-expanding (63%) devices. The 1-year mortality was 21.8% (87 patients) and 5-year mortality was 53.8% (215 patients). Median follow-up was 45.5 months (14.0-68.9) totaling 1516.7 patient/years, with the longest follow-up being 10.25 years. At least one follow-up echocardiogram was available for 320 patients (80%), SVD occurred in 19 of these patients (5.94%): moderate in 17 patients (5.31%) and severe in two patients (0.63%). The hemodynamic presentation was stenosis in most of the cases (12 patients). Late BVF was registered in 10 patients (3.13%) and this was mainly driven by transcatheter paravalvular leak closure (six patients) with subsequent good long-term outcome. Our results confirm that TAVR appears to be a long-lasting treatment strategy with low rates of structural valve degeneration and valve failure.

Routine minimalist transcatheter aortic valve implantation with local anesthesia only.

AIMS: Conscious sedation instead of general anesthesia has been increasingly adopted in many centers for transfemoral transcatheter aortic valve replacement (TAVR). Improvement of materials and operators' experience and reduction of periprocedural complications allowed procedural simplification and adoption of a minimalist approach. With this study, we sought to assess the feasibility and safety of transfemoral TAVR routinely performed under local anesthesia without on-site anesthesiology support. METHODS: The routine transfemoral TAVR protocol adopted at our center includes a minimalist approach, local anesthesia alone with fully awake patient, anesthesiologist available on call but not in the room, and direct transfer to the cardiology ward after the procedure. All consecutive patients undergoing transfemoral TAVR between January 2015 and July 2018 were included. We assessed the rates of actual local anesthesia-only procedures, conversion to conscious sedation or general anesthesia and 30-day clinical outcomes. RESULTS: Among 321 patients, 6 received general anesthesia upfront and 315 (98.1%) local anesthesia only. Mean age of the local anesthesia group was 83.2 ±â€Š6.9 years, Society of Thoracic Surgery score 5.8 ±â€Š4.8%. A balloon-expandable valve was used in 65.7%. Four patients (1.3%) shifted to conscious sedation because of pain or anxiety; 6 patients (1.9%) shifted to general anesthesia because of procedural complications. Hence, local anesthesia alone was possible in 305 patients (96.8% of the intended cohort, 95% of all transfemoral procedures). At 30 days, in the intended local anesthesia group, mortality was 1.6%, stroke 0.6%, major vascular complications 2.6%. Median hospital stay was 4 days (IQR 3-7). CONCLUSION: Transfemoral TAVR can be safely performed with local anesthesia alone and without an on-site anesthesiologist in the vast majority of patients.

Coronary artery disease and reasonably incomplete coronary revascularization in high-risk patients undergoing transcatheter aortic valve implantation.

OBJECTIVES: To evaluate the long-term impact of coronary artery disease (CAD) and heart team-guided incomplete coronary revascularization in patients undergoing transcatheter aortic valve implantation (TAVI). BACKGROUND: Revascularization strategy of CAD diagnosed with routine coronary angiography before TAVI is uncertain. METHODS: Five hundred and forty consecutive TAVI patients were classified as having CAD or normal coronary arteries (no-CAD). Within the CAD group, patients were further classified as those with complete (CR) versus incomplete revascularization (IR). Revascularization strategy was guided by the Heart Team following an algorithm largely based on current guidelines. Main outcome of interest was the incidence of 5-year cardiovascular (CV) death. RESULTS: Prevalence of CAD was 53.9%. CAD patients showed significantly lower left ventricular ejection fraction (LVEF: 55.8 ± 13.4% CAD vs. 61.4% ± 12.1 no-CAD, p < .0001), lower gradients, and larger ventricular volumes in comparison with the no-CAD group. Within the CAD group, 138 patients (47.4%) received CR and 153 (52.6%) IR. In-hospital mortality was 3.9%, without significant difference between groups (4.0% no-CAD vs. 3.8% CAD, p = .88; 2.9% CR vs. 4.6% IR, p = .45). Median follow-up was 57.8 months. Five-year survival free from CV death was 79.6% in the CAD versus 77.9% in the no-CAD group (p = .98), and 84.3% in the CR versus 74.3% in the IR groups (p = .25). These results were confirmed excluding patients with previous revascularization. At multivariable analyses, presentation with acute coronary syndrome (ACS) was significantly associated with 5-year CV death. CONCLUSIONS: CAD is frequent in patients undergoing TAVI but portends an adverse prognosis only when presenting with ACS. Heart-team directed complete or reasonably incomplete revascularization was associated with comparable outcomes.

In-hospital and thirty-day outcomes of the SAPIEN 3 Ultra balloon-expandable transcatheter aortic valve: the S3U registry.

AIMS: The aim of this study was to evaluate 30-day safety and efficacy outcomes of transcatheter aortic valve implantation (TAVI) performed with the SAPIEN 3 Ultra system. METHODS AND RESULTS: The S3U registry is a physician-led, post-approval, multicentre, observational registry of transfemoral TAVI with the SAPIEN 3 Ultra. New features include an improved sealing skirt, a 14 Fr expandable sheath and a new delivery catheter. Overall, 139 consecutive patients at nine participating centres were enrolled. Mean age was 81.4±8.3 years, average STS score 3.8±2.4%. The vast majority (97.2%) underwent TAVI with local anaesthesia (28.8%) or conscious sedation (68.3%). Balloon predilatation was performed in 30 patients (21.6%), post-dilatation in three (2.2%). In-hospital, there were no cases of death, stroke, or conversion to open heart surgery. Major vascular complications occurred in three patients (2.2%), as well as major or life-threatening bleedings in three patients (2.2%). There were two moderate (1.4%) and no moderate/severe paravalvular leaks. Median length of stay after TAVI was three days (IQR 3-5 days). At 30 days, there were no deaths, MI, or strokes, and the incidence of new permanent pacemaker implantation was 4.4%. CONCLUSIONS: This first multicentre international experience of transfemoral TAVI with the SAPIEN 3 Ultra transcatheter heart valve shows good in-hospital and 30-day clinical outcomes.

Surgical Risk Scores Applied to Transcatheter Aortic Valve Implantation: Friends or Foes? Short-Term and Long-Term Outcomes From a Single-Center Registry.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) is a valid alternative to surgical aortic valve replacement for the treatment of symptomatic aortic stenosis. The EuroScore (ES) II, logistic EuroScore (log ES), and the Society of Thoracic Surgeons (STS) score are the most applied scores for surgical risk stratification. However, their predictive value for patients undergoing TAVI is still unclear. AIM: To evaluate the performance of STS, log ES and ES II as predictors of short-term and long-term mortality in patients undergoing TAVI. METHODS: Between February 2008 and October 2017, a total of 384 patients underwent transfemoral TAVI at our institution and constituted the study population. Patients were divided into three groups based on the class of risk (low, intermediate, and high) calculated by each score. In-hospital complications, 30-day outcomes, and 5-year outcomes were assessed. RESULTS: In-hospital mortality rate was 2.6% (n = 10). All scores over-estimated the risk of 30-day mortality, especially for the highest risk classes. At the end of follow-up (5 years), STS risk stratification was able to stratify all-cause and cardiovascular (CV) mortality (P<.01 and P=.02, respectively). Patients with intermediate ES II risk showed a lower survival rate (P=.04) while CV deaths did not differ between classes of risk. All-cause mortality and CV mortality curves did not diverge according to the patients' risk profiles derived from log ES. CONCLUSION: Conventional surgical risk scores are not appropriate to predict 30-day mortality in patients undergoing transfemoral TAVI. STS assessment was the only risk score able to stratify long-term all-cause and CV mortality.