Edge-to-edge percutaneous mitral repair for functional ischaemic and non-ischaemic mitral regurgitation: a systematic review and meta-analysis.

AIM: Randomized controlled trials comparing the use of the MitraClip device in addition to guideline directed medical therapy (GDMT) to GDMT alone in patients with secondary mitral regurgitation (MR) have shown conflicting results. However, if these differences could be due to the underlying MR aetiology is still unknown. Therefore, we aimed to evaluate if the effects of percutaneous edge-to-edge repair with MitraClip implantation could differ in patients with ischaemic (I-MR) and non-ischaemic mitral regurgitation (NI-MR). METHODS AND RESULTS: PubMed, Embase, BioMed Central, and the Cochrane Central Register of Controlled Trials were searched for all studies including patients with secondary MR treated with the MitraClip device. Data were pooled using a random-effects model. Primary endpoint was the composite of all-cause death and heart failure-related hospitalization. Secondary endpoints were the single components of the primary endpoint, New York Heart Association functional Classes III and IV, and mitral valve re-intervention. Seven studies enrolling 2501 patients were included. Patients with I-MR compared with patients with NI-MR had a similar risk of the primary endpoint (odds ratio: 1.17; 95% confidence interval: 0.93 to 1.46; I2 : 0%). The risk of all-cause death was increased in patients with I-MR (odds ratio: 1.31; 95% confidence interval: 1.07 to 1.62; I2 : 0%), while no differences were observed between the two groups in terms of the other secondary endpoints. CONCLUSIONS: The risk of mortality after MitraClip implantation is lower in patients with NI-MR than in those with I-MR. No absolute differences in the risk of heart failure related hospitalization were observed between groups.

Primary Percutaneous Coronary Intervention with High-Bolus Dose Tirofiban: The FASTER (Favorite Approach to Safe and Effective Treatment for Early Reperfusion) Multicenter Registry.

Objectives: To investigate the safety and clinical efficacy of tirofiban during primary percutaneous coronary interventions (pPCI). Background: Gp IIb/IIIa inhibitors (GPI) use during pPCI has declined over years, mainly for the increased hemorrhagic risk associated to their use and for the availability of potent, fast-acting oral antiplatelet drugs. However, several pharmacodynamic studies showed suboptimal platelet inhibition with P2Y12-blockers, such as prasugrel or ticagrelor. Methods: Patients with ST-segment elevation myocardial infarction (STEMI) undergoing pPCI were prospectively enrolled in a multicenter registry conducted in high-volume centers in Italy. All patients received intraprocedural tirofiban. The primary safety endpoint was the occurrence of in-hospital bleedings according to the Bleeding Academic Research Consortium definition. In-hospital major adverse coronary events (MACE, defined as death, reinfarction, stent thrombosis, and target vessel revascularization), final TIMI flow, myocardial blush grade, and ST-segment resolution were also evaluated. Results: A total of 472 patients (mean age 61 ± 11 years, 83% males) were enrolled in 16 Italian centers from October 2015 to June 2018. Mean basal thrombus grade score was 3.47 ± 1.25. PCI was performed by transradial approach in 88% of patients. We observed a very low rate of 30 days BARC bleedings (2.1%) and MACE (0.8%). Complete (>70%) ST-segment resolution was observed in 67% of patients. Conclusions: In the FASTER registry, the use of tirofiban during primary PCI, performed with a transradial approach in most cases, in patients with high thrombus burden was associated with high rates of complete ST-segment resolution and low rates of in-hospital bleeding and MACE.

Outcomes on safety and efficacy of left atrial appendage occlusion in end stage renal disease patients undergoing dialysis.

BACKGROUND: In patients with end stage renal disease and atrial fibrillation (AF), undergoing chronic dialysis, direct oral agents are contraindicated and warfarin does not fully prevent embolic events while increasing the bleeding risk. The high hemorrhagic risk represents the main problem in this population. Aim of the study was to estimate the safety and efficacy for thromboembolic prevention of left atrial appendage (LAA) occlusion in a cohort of dialysis patients with AF and high hemorrhagic risk. METHODS: Ninety-two dialysis patients with AF who underwent LAA occlusion were recruited. For comparative purposes, two cohorts of dialysis patients with AF, one taking warfarin (oral anticoagulant therapy, OAT cohort, n = 114) and the other not taking any OAT (no-therapy cohort, n = 148) were included in the study. Primary endpoints were (1) incidence of peri-procedural complications, (2) incidence of 2-year thromboembolic and hemorrhagic events, (3) mortality at 2 years. In order to evaluate the effect of the LAA occlusion on the endpoints with respect to the OAT and No-therapy cohorts, a multivariable Cox regression model was applied adjusted for possible confounding factors. RESULTS: The device was successfully implanted in 100% of cases. Two major peri-procedural complications were reported. No thromboembolic events occurred at 2-year follow-up. The adjusted multivariable Cox regression model showed no difference in bleeding risk in the OAT compared to the LAA occlusion cohort in the first 3 months of follow-up [HR 1.65 (95% CI 0.43-6.33)], when most of patients were taking two antiplatelet drugs. In the following 21 months the bleeding incidence became higher in OAT patients [HR 6.48 (95% CI 1.32-31.72)]. Overall mortality was greater in both the OAT [HR 2.76 (95% CI 1.31-5.86)] and No-Therapy [HR 3.09 (95% CI 1.59-5.98)] cohorts compared to LAA occlusion patients. CONCLUSIONS: The study could open the way to a non-pharmacological option for thromboembolic protection in dialysis patients with AF and high bleeding risk.

Incidence, Technical Safety, and Feasibility of Coronary Angiography and Intervention Following Self-expanding Transcatheter Aortic Valve Replacement.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) is a well-established treatment option for severe aortic stenosis (AS). AS and coronary artery disease frequently coincide, and therefore some patients may require coronary angiography (CAG) and/or intervention (PCI) post-TAVR. Due to valve stent design, most self-expanding prostheses always cover the coronary ostium, and therefore may hinder future access. The objective of this research was to evaluate the incidence, safety and feasibility of CAG/PCI in patients with prior self-expanding TAVR valves. METHODS: Among 2170 patients (age 82 ±â€¯6 years, 43% male) who underwent TAVR with Corevalve or Evolut prostheses, as part of the Italian CoreValve ClinicalService® framework (data from 13 Italian centers), the occurrence of CAG/PCI following TAVR and periprocedural characteristics were examined. RESULTS: During median follow-up of 379 days, 41 patients (1.9%) required CAG and/or PCI (total 46; 16 CAG, 14 PCI, 16 both PCI/CAG). 56.5% of the procedures were performed under emergency/urgency settings. Left system coronary angiography was successfully performed in most cases (28/32, 87.5%), while right coronary angiography was successful only in 50.0% (16/32). PCI procedures (20 for left system, 3 for right system, 4 for graft) were successfully performed in 93.3% (28/30) of the procedures. No CAG/PCI procedure-related complications including prosthesis dislodgment or coronary ostium dissection occurred. CONCLUSIONS: CAG and PCI procedures following CoreValve TAVR is safe and mostly feasible, although the success rate of selective right coronary angiography was relatively low when compared to the left system. Further investigations are required to explore this issue.

Left ventricular reverse remodelling predicts long-term outcomes in patients with functional mitral regurgitation undergoing MitraClip therapy: results from a multicentre registry.

AIMS: To explore whether left ventricular reverse remodelling (LVRR) is a predictor of outcomes in patients with functional mitral regurgitation (FMR) undergoing MitraClip procedure. METHODS AND RESULTS: We analysed 184 consecutive patients with FMR who underwent successful MitraClip procedure. LVRR was defined as a reduction in left ventricular end-systolic volume ≥ 10% from baseline to 6 months. LVRR was observed in 79 (42.9%) patients. Compared with non-LVRR, LVRR patients were more likely to be females, less likely to have an ischaemic aetiology of mitral regurgitation or a prior (<6 months) heart failure (HF) hospitalization, and had smaller left ventricular dimensions. New York Heart Association class improved from baseline up to 1-year follow-up in both groups. Higher rates of overall survival (87.3% vs. 75.2%, P = 0.039), freedom from HF hospitalization (77.2% vs. 60%, P = 0.020), and freedom from the composite endpoint (cardiovascular mortality or HF hospitalization) (74.7% vs. 55.2%; P = 0.012) were observed in LVRR vs. non-LVRR patients at 2-year follow-up. LVRR was associated with a significant reduction of the adjusted relative risk of mortality, HF hospitalization and composite endpoint [hazard ratio (HR) 0.44; 95% confidence interval (CI) 0.20-0.96, P = 0.040; HR 0.55; 95% CI 0.32-0.97, P = 0.038; and HR 0.54; 95% CI 0.32-0.92, P = 0.023, respectively]. Female gender, absence of diabetes, freedom from prior HF hospitalization, non-ischaemic aetiology of mitral regurgitation, and left ventricular end-diastolic diameter < 75 mm were found to be independent predictors of LVRR. CONCLUSIONS: Left ventricular reverse remodelling is associated with better long-term outcomes in patients with FMR successfully treated with MitraClip. A careful patient selection may be useful as specific baseline features predict favourable left ventricular remodelling. [Correction added on 17 January 2019, after online publication: the preceding sentence has been changed.].

EkoSonic Endovascular System for patients with acute pulmonary embolism and contraindication to systemic fibrinolysis.

AIMS: The aim of this study was to evaluate the safety and efficacy of the EkoSonic Endovascular System (EKOS) in patients with acute pulmonary embolism (APE) at high or intermediate-high risk and contraindication to systemic fibrinolysis. METHODS: This is a retrospective study including consecutive patients admitted due to high-risk or intermediate-high-risk APE and treated by EKOS because of an absolute or relative contraindication to systemic fibrinolysis. The primary efficacy end-point was the change from baseline to 72 h in right to left ventricular dimension ratio [right ventricular/left ventricular (RV/LV) ratio]; pulmonary embolic burden using the Qanadli Index; and systolic pulmonary arterial pressure (SPAP). The primary safety end-point was the occurrence of bleeding (GUSTO classification) within 72 h. RESULTS: Eighteen patients (5 men, 13 women; mean age 74 ±â€Š12.7 years) affected by high-risk APE (n = 5; 27.8%) or intermediate-high-risk APE (n = 13; 72.2%) were included. A significant reduction of mean RV/LV ratio (1.38 ±â€Š0.3 vs. 0.97 ±â€Š0.16; P < 0.0005); Qanadli Index [27.06 ±â€Š2.6 vs. 18.8 ±â€Š7.8 (P < 0.001) and SPAP (71.1 ±â€Š12 vs. 45.2 ±â€Š16 mmHg; P < 0.001)] was observed within 72 h after EKOS. Five bleeding events occurred: one fatal and four moderates; three out of them led to the access site hematoma, two due to pre-existing active bleeding. CONCLUSION: EKOS is an effective tool to treat patients with APE at high or intermediate-high risk and contraindication to fibrinolysis. It is a relatively safe therapy considering the critical conditions and high bleeding risk of the receiving population.

Comparison of Early and Long-Term Outcomes After Transcatheter Aortic Valve Implantation in Patients with New York Heart Association Functional Class IV to those in Class III and Less.

Our aim was to investigate the impact of a baseline New York Heart Association (NYHA) class IV on clinical outcomes of a large real-world population who underwent transcatheter aortic valve implantation (TAVI). The primary end points were all-cause mortality, cardiovascular mortality, and re-hospitalization, evaluated at the longest available follow-up and by means of a 3-month landmark analysis. The secondary end points were: change in NYHA class, left ventricular ejection fraction, pulmonary pressure and mitral regurgitation. Out of 2,467 patients, 271 (11%) had a NYHA functional class IV at the admission. The latter had higher Society of Thoracic Surgeons (STS) score (9.2% vs 5.5%; p < 0.001) compared to NYHA ≤ III patients, owing to more comorbidities (prior myocardial infarction, severe long-term kidney disease, atrial fibrillation, left ventricular dysfunction, significant mitral regurgitation, pulmonary hypertension). Device success was similar between the two groups (93.7% vs 94.5%; p = 0.583). At a median follow-up of 15 months (interquartile range 4 to 36 months) a lower freedom from primary end points was observed among NYHA IV versus NYHA ≤ III group (survival from all-cause death: 52% vs 58.4%; p = 0.002; survival from cardiovascular death: 72.5% vs 76.5%; p = 0.091; freedom from re-hospitalization: 81.5% vs 85.4%; p = 0.038). However, after adjustment for baseline imbalance, NYHA IV did not influence the relative risk of long-term primary end points. A 3-month landmark analysis showed that NYHA IV independently predicted 3-month all-cause and cardiovascular mortality (hazard ratio: 1.77; 95% CI [1.10 to 2.83]; p = 0.018 and hazard ratio: 1.64; 95% CI [1.03 to 2.59]; p = 0.036, respectively). Instead, after 3-month follow-up NYHA IV did not affect the risk of primary end points. A significant improvement of the secondary end points was noted in both NYHA IV and NYHA ≤≤ III groups. In conclusion, the presence of NYHA class IV in TAVI candidates was associated to a significant increased risk of mortality within 3 months. Patients with baseline NYHA IV who survived at 3 months had a long-term outcome comparable to that of other subjects. Left ventricular systolic function, pulmonary pressure, and mitral insufficiency significantly improved after TAVI regardless of baseline NYHA class IV.

[Updated SICI-GISE position paper on institutional and operator requirements for transcatheter aortic valve implantation]. / Update del documento di posizione della Società Italiana di Cardiologia Interventistica (SICI-GISE) sui requisiti minimi per ospedali ed operatori che eseguono procedure di impianto transcatetere di protesi valvolare aortica.

Transcatheter aortic valve implantation (TAVI) has revolutionized the management of patients with symptomatic severe aortic stenosis and has become the standard of care for inoperable patients and the preferred therapy for those at increased surgical risk with peculiar clinical and anatomic features. Technology advances, growing experience and accumulating data prompted the update of the 2011 Italian Society of Interventional Cardiology (SICI-GISE) position paper on institutional and operator requirements to perform TAVI. The main objective of this document is to provide a guidance to assess the potential of institutions and operators to initiate and maintain an efficient TAVI program.

Two-year cardiac mortality after MitraClip treatment of functional mitral regurgitation in ischemic and non-ischemic dilated cardiomyopathy.

BACKGROUND: MitraClip implantation has evolved as a new tool for treatment of inoperable or high-risk patients with severe functional mitral regurgitation (FMR) due to dilated cardiomyopathy (DCM). Limited data are available regarding MitraClip outcomes comparing patients with ischemic and non-ischemic DCM. METHODS: From 2008 to 2016, 314 patients received MitraClip for FMR at four institutions: Brescia, Zurich and Milan. Patients were stratified according to MR aetiology in non-ischemic FMR (n = 99) and ischemic FMR (n = 215). Preoperative risk factors, operative variables and outcomes up to 2-year were evaluated. A multivariable Cox Proportional Hazards survival model with covariate adjustments was used to assess the relationship between FMR aetiology and 2-year cardiac mortality. RESULTS: As expected, patients with ischemic FMR had significantly more risk factors and comorbidities. Overall procedural success rate was 80% and in-hospital cardiac mortality was 3% without significant differences between aetiology. Two-year overall (25% vs. 19%, p = 0.574) and cardiac (18% vs. 16%, p = 0.990) mortality rates were comparable. No differences were detected in terms of re-hospitalization rates (32%), LVAD implantation (4.5%) and mitral valve surgery (1%). LVEF ≤ 25%, LVEDV > 216 ml, NT-proBNP ≥ 10.000 pg/ml and AF were the strongest baseline predictors of 2-year cardiac mortality. Greater improvements of 6MWT and NYHA functional class were observed in patients with non-ischemic FMR. CONCLUSIONS: The ischemic or non-ischemic aetiology of DCM did not affect in-hospital and 2-year cardiac mortality after MitraClip in patients with FMR. In case of unfavorable baseline clinical condition, the indication for MitraClip should be carefully weighed in favour of conservative medical therapy alone or left ventricular assist device.

Self-expanding transcatheter aortic valve implantation for degenerated small Mitroflow bioprosthesis: early and midterm outcomes.

AIMS: The aim of this study was to report clinical outcomes of self-expanding transcatheter aortic valve implantation (TAVI) for failed small Mitroflow (MF) bioprostheses. METHODS AND RESULTS: Between January 2013 and July 2016, 15 symptomatic patients (NYHA Class ≥III) with degenerated small MF (≤23 mm) underwent CoreValve (CV) or Evolut R (EvR) implantation due to high/prohibitive risk for surgical redo. The MF size was 19 or 21 mm (off-label in Europe) in eight patients. A "preventive" left main (LM) stenting was successfully performed in one patient. Early LM obstruction occurred in two cases requiring stenting. Late LM obstruction was observed in one subject. A significant correlation between virtual left transcatheter valve-to-coronary ostia (VTC) distance and left sinus of Valsalva (LSV) diameter was observed (R=0.652; p=0.012). However, only left VTC was significantly smaller in patients who experienced LM obstruction compared to those who did not (p=0.002). No cases of moderate/severe stenosis were observed in either on- or off-label procedures. No death or other major events occurred up to the one-year follow-up. CONCLUSIONS: CV or EvR implantation for failed small MF has favourable early and midterm outcomes if a careful risk evaluation and preventive measures for coronary obstruction are adopted. Low gradients can be achieved regardless of MF size.

Transcathether aortic valve implantation with the new repositionable self-expandable Evolut R versus CoreValve system: A case-matched comparison.

BACKGROUND: Despite promising results following transcatheter aortic valve implantation (TAVI), several relevant challenges still remain. To overcome these issues, new generation devices have been developed. The purpose of the present study was to determine whether TAVI with the new self-expanding repositionable Evolut R offers potential benefits compared to the preceding CoreValve, using propensity matching. METHODS: Between June 2007 and November 2015, 2148 consecutive patients undergoing TAVI either CoreValve (n=1846) or Evolut R (n=302) were prospectively included in the Italian TAVI ClinicalService® project. For the purpose of our analysis 211 patients treated with the Evolut R were matched to 211 patients treated with the CoreValve. An independent core laboratory reviewed all angiographic procedural data and an independent clinical events committee adjudicated all events. RESULTS: Patients treated with Evolut R experienced higher 1-year overall survival (log rank test p=0.045) and a significantly lower incidence of major vascular access complications, bleeding events and acute kidney injury compared to patients treated with the CoreValve. Recapture manoeuvres to optimize valve deployment were performed 44 times, allowing a less implantation depth for the Evolut R. As a consequence, the rate of more than mild paravalvular leak and new permanent pacemaker was lower in patients receiving the Evolut R. CONCLUSION: In this matched comparison of high surgical risk patients undergoing TAVI, the use of Evolut R was associated with a significant survival benefit at 1year compared with the CoreValve. This was driven by lower incidence of periprocedural complications and higher rates of correct anatomic positioning.

Percutaneous edge-to-edge mitral valve repair for the treatment of acute mitral regurgitation complicating myocardial infarction: A single centre experience.

BACKGROUND: Limited evidence is available about MitraClip therapy in patients with acute mitral regurgitation (MR) complicating myocardial infarction (MI). METHODS AND RESULTS: Among 80 consecutive patients undergoing MitraClip treatment, 5 (6.3%) had been admitted for acute MI complicated by severe MR. Mean age was 73±6years and 3 were males. At the time of admission they were in cardiogenic shock (80%) or pulmonary oedema (20%), with severe MR, left ventricular dysfunction and pulmonary hypertension. The indication to MitraClip treatment was based on severe hemodynamic instability with dependence on intravenous therapy and mechanical supports despite percutaneous coronary revascularization and on high surgical risk of 27.1±13% and 10.2±6% using Euroscore II and STS score respectively. MitraClip procedure was performed at 53±33days from admission. One or two clips were employed in 2 and 3 patients respectively. Procedural success (MR≤2+) was achieved in all patients without complications and with successful weaning from mechanical supports and intravenous drugs in all but one patient who underwent left ventricular assist device implantation at 60days from MitraClip procedure. MR recurrence occurred at 30-day follow-up in one patient who had concomitant aortic regurgitation. One patient died during follow-up for non-cardiovascular cause. However, recovery of hemodynamic balance with significant and persistent pulmonary pressure reduction and functional status improvement up to 2-year follow-up was observed in most of the patients. CONCLUSIONS: Critical patients with acute ischemic MR post-MI with persistence of hemodynamic instability after coronary revascularization may benefit from MitraClip therapy acutely with favourable long-term follow-up results.

Effects of drug-eluting stents after rotational atherectomy: evidence from a multicenter experience.

AIMS: Rotational atherectomy is used as an adjuvant tool for percutaneous coronary interventions, especially in case of highly calcific atherosclerotic plaques. Subsequent drug-eluting stent (DES) implantation is common; however, there is a paucity of clinical evidence to support this practice. METHODS: From the databases of four high-volume Italian centers, we analyzed the angiographic outcome of patients who underwent rotational atherectomy in native coronary vessels followed by DES or bare metal stent (BMS) implantation. Primary study endpoint was late lumen loss at the longest available follow-up. Other analyses consisted of the evaluation of in-stent percentage diameter stenosis, binary restenosis, major adverse cardiovascular events, and stent thrombosis at angiographic control. RESULTS: Between 2006 and 2011, 672 patients with 734 lesions treated had complete angiographic follow-up and were enrolled into this study; 385 lesions were treated with DES and 349 with BMS. The average follow-up length was 9 ±â€Š5 months. Only a few significant differences regarding baseline clinical and angiographic characteristics were observed. Late lumen loss result significantly improved after DES implantation in comparison with BMS (0.54 ±â€Š0.79 vs. 1.01 ±â€Š1.13; P = 0.001), as well as in-stent percentage diameter stenosis (P = 0.01) and binary restenosis (P = 0.007). Major adverse cardiovascular events did not differ significantly, but showed an improved trend in the DES group, driven by a significantly lower target lesion revascularization (6.9 vs. 11.6%; P = 0.04). CONCLUSION: In a cohort of patients treated with rotational atherectomy and with complete angiographic follow-up, DES implantation is associated with improved late lumen loss over BMS. However, the DES effect in terms of angiographic endpoints seems mitigated if compared to previous studies.

Transaxillary versus transaortic approach for transcatheter aortic valve implantation with CoreValve Revalving System: insights from multicenter experience.

BACKGROUND: About one-third of candidates for transcatheter aortic valve implantation (TAVI) suffer from severe peripheral artery disease, making the routine femoral approach difficult or impossible. The aim was to compare the transaxillary (TAx) and the transaortic (TAo) route for TAVI with Medtronic CoreValve Revalving System (CRS). METHODS: Out of 1049 consecutive TAVI with 18F CRS, 242 (23%) were treated in 4 high-volume Italian Centre through TAx (61%) and TAo (39%). RESULTS: The devices success was similar (P=0.16) with a trend to a lower incidence of significant paravalvular leak (6% vs. 14%, P=0.07) and a significant reduction of permanent pacemaker (PPM) implantation (13% vs. 34%, P=0.017) in the TAo. However, this route showed a higher incidence of acute kidney injury (P=0.016) and a longer hospital stay after the index procedure (days 10 [8-14] vs. 8 [7-12], P=0.001). By a multivariate analysis the vascular access is an independent predictor for a longer hospital stay (TAo route; OR=0.37, 95% CI: 0.18-0.75; P=0.006) and for PPM implantation (TAx route; OR=3.7, 95% CI: 1.2-10.8; P=0.017). CONCLUSIONS: Although the higher clinical risk profile of transaortic population, the TAo approach showed an equally high device success with similar 30-day safety and 1year efficacy, compared to TAx route. However, due to non-procedure-specific complications post-TAo TAVI, this route requires a specialized postoperative care and the treatment of patients in highly specialized and experienced centers.

One-Year Outcomes of Transcatheter Aortic Valve Implantation Using the Direct Aortic Approach.

BACKGROUND: The direct aortic (DA) approach allows for transcatheter aortic valve implantation (TAVI) in patients with difficult peripheral vascular anatomy. The CoreValve ADVANCE Direct Aortic (ADVANCE DA) study was performed to assess the outcomes of DA TAVI with the CoreValve System (Medtronic, Minneapolis, MN) in routine practice. METHODS: Patients were selected for the DA approach by local cardiac surgical teams, and TAVI was performed with patients under general anesthesia. Safety events were adjudicated according to the Valve Academic Research Consortium-2 definitions by an independent clinical events committee. All imaging data, including that from multislice computed tomography and follow-up echocardiography, were analyzed by an independent core laboratory. RESULTS: From September 2012 to February 2014, 100 patients were enrolled (52.0% male, age 81.9 ± 5.9 years, The Society of Thoracic Surgeons Score 5.9 ± 3.2%) at 9 centers in Europe. Peripheral vascular disease was present in 51.0% of patients, and 38.0% had diabetes. Of the 100 patients enrolled, 92 underwent TAVI. At 30 days after TAVI, 98.1% were free of moderate or severe paravalvular leak. At 1 year, 16 patients had died (Kaplan-Meier rate 17.9%), 1 (1.1%) patient had had a stroke, classified as nondisabling, and 15 (17.0%) patients had received a permanent pacemaker. Most patients experienced improved quality of life as measured by the Kansas City Cardiomyopathy Questionnaire overall summary score (mean change from baseline to 1 year, 39.6 ± 26.3; p < 0.01). CONCLUSIONS: The DA approach provides a feasible alternative for patients with challenging anatomic features that may otherwise preclude use of the TAVI procedure.

Acute and long-term (2-years) clinical outcomes of the CoreValve 31mm in large aortic annuli: A multicenter study.

INTRODUCTION: Little is known about the early and late performance of the 31mm CoreValve Revalving System (CRS, Medtronic Inc., Galway, Ireland). Our aim was to compare acute and long-term results of the 31mm CRS with other valve sizes. METHODS: Consecutive patients undergoing transcatheter aortic valve implantation (TAVI) with CRS in nine Italian centers were prospectively included and dichotomized according to prosthesis size in two different groups, as follows: 31mm and other valve sizes (i.e., 23, 26, and 29mm combined). End points were defined according to Valve Academic Research Consortium definitions. Propensity score matching was performed. RESULTS: In total, 2069 patients (n=169 [8%] in the 31mm group and n=1900 [92%] in the other valve sizes group) were included. After propensity matching, the implantation of the 31mm valve was associated with lower rates of procedural- (91.3% vs. 98.1%, p=0.030) and device-success (88.5% vs. 97.1%, p=0.016), longer procedural time (120 [80-180] min. vs. 90 [60-120] min., p<0.001), and higher rates of implantation of a second valve (10.6% vs. 2.9%, respectively, p=0.027). The rates of permanent pacemaker implantation in the 31mm group were higher but not statistically different from other valve sizes (41.7% vs. 30.9%, respectively, p=0.149). Significant improvement, without between-group differences, was observed in NYHA functional class. Cardiovascular death was lower in the 31mm valve group through 2-years (3.8% vs. 13.5%, respectively, p=0.014). CONCLUSIONS: The acute performance of the 31mm CRS was worse than other valve sizes but no negative impact was observed in long-term outcomes.

The failing right heart: implications and evolution in high-risk patients undergoing transcatheter aortic valve implantation.

AIMS: Right ventricular dysfunction (RVdy) is negatively associated with survival after left heart valve surgery. It is unclear whether RVdy has the same impact in patients undergoing transcatheter aortic valve implantation (TAVI). We sought to evaluate the prognostic impact of different grades of RVdy on TAVI, with and without concomitant left ventricular dysfunction (LVdy), and the possible impact of TAVI on RVdy. METHODS AND RESULTS: Among 870 consecutive patients with severe symptomatic aortic stenosis undergoing TAVI, 226 patients (26%) presented with a concomitant diagnosis of RVdy. Patients were divided into three groups, Group 1: normal RV systolic function, i.e., tricuspid annular plane systolic excursion (TAPSE) >16 mm (n=644, 74%); Group 2: mild-to-moderate RVdy, i.e., TAPSE 10-16 mm (n=180, 20.6%); Group 3: severe RVdy, i.e., TAPSE <10 mm (n=46, 5.2%). Patients in Groups 1 and 2 showed a similar overall mortality rate at one month (5% vs. 8%, OR 1.1 [0.7-1.55], p=0.2) and at one-year follow-up (15% vs. 19%, HR 1.5 [0.84-2.2], p=0.09), respectively. Compared to Groups 1 and 2, patients in Group 3 showed a significantly higher overall mortality at one month (22%, OR 3.3 [1.8-4.1], p<0.001, and OR 2.1 [1.7-3.1], p=0.02, respectively) as well as at one-year follow-up (45%, HR 2.6 [2.1-3.45], p<0.001, and HR 1.9 [1.5-2.7], p=0.02), respectively. Pulmonary hypertension >60 mmHg (HR 1.5 [1.1-2.2], p=0.03), AF (HR 1.6 [1.1-2.4], p=0.01), creatinine clearance <30 mL/min (HR 1.92 [1.3-2.5], p=0.003), LVEF <30% (HR 1.5 [1.1-2.9], p=0.03), severe RVdy (HR 2.9 [2.7-3.3], p=0.002), severe RV dilation (HR 1.7 [1.2-2.2], p=0.005) and severe biventricular dysfunction (HR 3.9 [2.7-4.1], p=0.002) were independent predictors of one-year mortality. Among survivors, the majority of patients in Groups 2 and 3 experienced a significant improvement in NYHA class. CONCLUSIONS: Severe RVdy limits the expected benefit of TAVI. In current risk scores right heart failure is not considered. The present study advocates the evaluation of this strong predictor in a more complete pre-procedural work-up.