Chiara Fraccaro

Incidence, Predictors, and Outcomes of Aortic Regurgitation After Transcatheter Aortic Valve Replacement Meta-Analysis and Systematic Review of Literature

OBJECTIVES This study was designed to establish the incidence, impact, and predictors of post-transcatheter aortic valve replacement (TAVR) aortic regurgitation (AR). BACKGROUND AR is an important limitation of TAVR with ill-defined predictors and unclear long-term impact on outcomes. METHODS Studies published between 2002 and 2012 with regard to TAVR were identified using an electronic search and reviewed using the random-effects model of DerSimonian and Laird. From 3,871 initial citations, 45 studies reporting on 12,926 patients (CoreValve [Medtronic CV Luxembourg S.a.r.l., Tolochenaz, Switzerland] n = 5,261 and Edwards valve [Edwards Lifesciences, Santa Ana, California] n = 7,279) were included in the analysis of incidence and outcomes of post-TAVR AR. RESULTS The pooled estimate for moderate or severe AR post-TAVR was 11.7% (95% confidence interval [CI]: 9.6 to 14.1). Moderate or severe AR was more common with use of the CoreValve (16.0% vs. 9.1%, p = 0.005). The presence of moderate or severe AR post-TAVR increased mortality at 30 days (odds ratio: 2.95; 95% CI: 1.73 to 5.02) and 1 year (hazard ratio: 2.27; 95% CI: -1.84 to 2.81). Mild AR was also associated with an increased hazard ratio for mortality, 1.829 (95% CI: 1.005 to 3.329) that was overturned by sensitivity analysis. Twenty-five studies reported on predictors of post-TAVR AR. Implantation depth, valve undersizing, and Agatston calcium score (r = 0.47, p = 0.001) were identified as important predictors. CONCLUSIONS Moderate or severe aortic regurgitation is common after TAVR and an adverse prognostic indicator of short- and long-term survival. Incidence of moderate or severe AR is higher with use of the CoreValve. Mild AR may be associated with increased long-term mortality. Therefore, every effort should be made to minimize AR by a comprehensive pre-procedural planning and meticulous procedural execution.

Incidence, Predictors, and Outcome of Conduction Disorders After Transcatheter Self-Expandable Aortic Valve Implantation

The aims of the present study were to investigate the incidence and characteristics of conduction disorders (CDs) after transcatheter aortic valve implantation (TAVI), to analyze the predictors of permanent pacemaker (PPM) implantation, and to evaluate the outcomes of CDs over time. In particular, we sought to investigate whether the depth of deployment and other technical aspects of valve implantation might predict the need for PPM implantation after TAVI. TAVI has been reported to favor the onset or worsening of CDs often requiring PPM implantation. A total of 70 patients with aortic stenosis due to dystrophic calcification underwent TAVI with third-generation CoreValve Revalving System from May 2007 to April 2009. We collected electrocardiograms at baseline, during TAVI, during hospitalization and at the 1-, 3-, 6-, and 12-month follow-up visits thereafter. The clinical, anatomic, and procedural variables were tested to identify the predictors of PPM implantation. The PPM dependency at follow-up was analyzed. Six patients were excluded from the analysis because of a pre-existing PPM. Of the 64 patients, 32 (50%) had one or more atrioventricular-intraventricular CDs at baseline. TAVI induced a worsening in the CDs in 49 (77%) of the 64 patients, with 25 (39%) requiring in-hospital PPM implantation. On multivariate analysis, the independent predictors of PPM implantation were the depth of the prosthesis implantation (p = 0.039) and the pre-existing right bundle branch block (p = 0.046). A trend in the recovery of the CDs over time was recorded, although 2 patients required PPM implantation 1 month after discharge for late complete atrioventricular block. In conclusion, TAVI often induces or worsens CDs, requiring PPM in more than one third of patients, although a trend in the recovery of CDs during the midterm was recorded. The independent predictors of PPM implantation were the depth of prosthesis implantation and pre-existing right bundle branch block.

Expanding the eligibility for transcatheter aortic valve implantation the trans-subclavian retrograde approach using: the III generation CoreValve revalving system.

OBJECTIVES Our aim was to assess the safety and feasibility of the retrograde trans-subclavian approach to transcatheter aortic valve implantation (TAVI) in selected high-risk patients with aortic stenosis (AS) and severe peripheral vasculopathy. BACKGROUND TAVI is an emerging therapeutic option to treat inoperable/high-risk patients affected by symptomatic AS. However, these patients are also often affected by severe iliac-femoral arteriopathy, rendering the transfemoral approach unemployable for percutaneous revalving procedure. METHODS From among those patients in our department between May 2007 and December 2008, who were refused surgical aortic valve replacement because of high surgical risk and were ineligible for transfemoral percutaneous aortic valve replacement, we scheduled 3 for TAVI by the subclavian approach. Procedures were performed by a combined team of cardiologists, cardiac surgeons, and anesthetists in the catheterization laboratory. The III generation CoreValve Revalving System (CoreValve Inc., Irvine, California) with an 18-F delivery system was introduced in all cases by the left subclavian artery. RESULTS Prosthetic valves were successfully implanted in all 3 cases, leading to a fall in transvalvular gradient without significant paravalvular regurgitation. No intraprocedural or periprocedural complications occurred. Two patients developed an atrioventricular block requiring the implantation of a permanent pacemaker. All patients were discharged in asymptomatic status, with good prosthesis performance. No adverse events occurred within the 3-month follow-up. CONCLUSIONS TAVI by subclavian retrograde approach seems safe and feasible in inoperable/high-risk patients with AS and peripheral vasculopathy, who are neither eligible for surgical valve replacement nor transfemoral percutaneous aortic valve implantation. Further studies are needed to evaluate the long-term efficacy of this new therapy.

Safety and effectiveness of a selective strategy for coronary artery revascularization before transcatheter aortic valve implantation

We assessed the safety and effectiveness of a selective percutaneous revascularization strategy before TAVI in a single‐center prospective registry.

Predictors and time-related impact of distal embolization during primary angioplasty

AIMS We sought to identify predictors of distal embolization (DE) occurring during primary percutaneous coronary intervention (p-PCI) as well as to assess its impact on both myocardial reperfusion and necrosis, according to time-to-treatment. METHODS AND RESULTS Clinical and angiographic characteristics were prospectively assessed in 400 consecutive patients who underwent p-PCI, in order to identify predictors of DE. The impact of DE on Thrombolysis in Myocardial Infarction (TIMI) flow, myocardial blush, and troponin I (TnI) was assessed according to symptom onset-to-balloon time. DE occurred in 64 (16%) patients and did not change with time-to-treatment (P = 0.87). The occlusion pattern of infarct-related artery (IRA), treatment of right coronary artery, higher TIMI thrombus score, longer lesion, and large IRA diameter were predictors of DE. The rate of TIMI 0/1 and myocardial blush 0/1 was higher in patients exhibiting DE when time-to-treatment was < or =6 h (P < 0.0001), while TnI was higher in patients with DE when time-to-treatment was <3 h. CONCLUSION DE during p-PCI occurs more often in the presence of high thrombus burden lesion. It reduces the effectiveness of myocardial reperfusion within 6 h and enhances myocardial damage within 3 h after symptom onset. Afterwards, it does not affect myocardial reperfusion or the extent of myocardial damage.

Transcatheter Aortic Valve Implantation in Patients With Severe Left Ventricular Dysfunction Immediate and Mid-Term Results, A Multicenter Study

Background— Few data exist about transcatheter aortic valve implantation (TAVI) in patients with low ejection fraction. The aim of the study was to analyze safety, feasibility, and efficacy of TAVI in patients with severe left ventricular dysfunction. Methods and Results— The study sample (384 patients) was divided into 2 groups: group A (50 patients) with left ventricular ejection fraction (LVEF) ⩽35%, and group B (334 patients) with LVEF >35%. Clinical, anatomic, and hemodynamic variables, as well as procedural results and follow-up outcomes, were compared between the groups. Procedural success was reached in 88%, with no significant difference between the groups. The incidence of periprosthetic leak >2+/4 after TAVI was higher in group A. All other complications were similar between the 2 groups. Group A showed a significant and early improvement in LVEF (from 27.7±6.0–35.2±11.1 after TAVI; P<0.0001). Thirty-day mortality was 4%; however, this was higher in group A compared with group B (10% versus 3%; P=0.010). Predictors of the cumulative late mortality were congestive heart failure, logistic euroSCORE, and moderate-to-severe periprosthetic leakage after TAVI. Estimated survival by Kaplan Meier at 1 year was, respectively, 69% in group A and 87% in group B (log rank <0.0001). Conclusions— Transcatheter aortic valve implantation is a safe and effective procedure, even in patients with severe left ventricular dysfunction, leading to a high procedural success rate with an acceptable rate of complications and 30-day mortality. Also in these critically ill patients, TAVI provides clinical amelioration, with early improvement in LVEF.

Determination of the Longest Intrapatient Left Ventricular Electrical Delay May Predict Acute Hemodynamic Improvement in Patients After Cardiac Resynchronization Therapy

Background—One of the reasons for patient nonresponse to cardiac resynchronization therapy is a suboptimal left ventricular (LV) pacing site. LV electric delay (Q-LV interval) has been indicated as a prognostic parameter of cardiac resynchronization therapy response. This study evaluates the LV delay for the optimization of the LV pacing site. Methods and Results—Thirty-two consecutive patients (23 men; mean age, 71±11 years; LV ejection fraction, 30±6%; 18 with ischemic cardiomyopathy; QRS, 181±25 ms; all mean±SD) underwent cardiac resynchronization therapy device implantation. All available tributary veins of the coronary sinus were tested, and the Q-LV interval was measured at each pacing site. The hemodynamic effects of pacing at different sites were evaluated by invasive measurement of LV dP/dtmax at baseline and during pacing. Overall, 2.9±0.8 different veins and 6.4±2.3 pacing sites were tested. In 31 of 32 (96.8%) patients, the highest LV dP/dtmax coincided with the maximum Q-LV interval. Q-LV interval correlated with the increase in LV dP/dtmax in all patients at each site (AR1 &rgr;=0.98; P<0.001). A Q-LV value >95 ms corresponded to a >10% in LV dP/dtmax. An inverse correlation between paced QRS duration and improvement in LV dP/dtmax was seen in 24 patients (75%). Conclusions—Pacing the LV at the latest activated site is highly predictive of the maximum increase in contractility, expressed as LV dP/dtmax. A positive correlation between Q-LV interval and hemodynamic improvement was found in all patients at every pacing site, a value of 95 ms corresponding to an increase in LV dP/dtmax of ≥10%.

Determination of the Longest Intra-Patient Left Ventricular Electrical Delay May Predict Acute Hemodynamic Improvement in Cardiac Resynchronization Therapy Patients

Background—One of the reasons for patient nonresponse to cardiac resynchronization therapy is a suboptimal left ventricular (LV) pacing site. LV electric delay (Q-LV interval) has been indicated as a prognostic parameter of cardiac resynchronization therapy response. This study evaluates the LV delay for the optimization of the LV pacing site. Methods and Results—Thirty-two consecutive patients (23 men; mean age, 71±11 years; LV ejection fraction, 30±6%; 18 with ischemic cardiomyopathy; QRS, 181±25 ms; all mean±SD) underwent cardiac resynchronization therapy device implantation. All available tributary veins of the coronary sinus were tested, and the Q-LV interval was measured at each pacing site. The hemodynamic effects of pacing at different sites were evaluated by invasive measurement of LV dP/dtmax at baseline and during pacing. Overall, 2.9±0.8 different veins and 6.4±2.3 pacing sites were tested. In 31 of 32 (96.8%) patients, the highest LV dP/dtmax coincided with the maximum Q-LV interval. Q-LV interval correlated with the increase in LV dP/dtmax in all patients at each site (AR1 &rgr;=0.98; P<0.001). A Q-LV value >95 ms corresponded to a >10% in LV dP/dtmax. An inverse correlation between paced QRS duration and improvement in LV dP/dtmax was seen in 24 patients (75%). Conclusions—Pacing the LV at the latest activated site is highly predictive of the maximum increase in contractility, expressed as LV dP/dtmax. A positive correlation between Q-LV interval and hemodynamic improvement was found in all patients at every pacing site, a value of 95 ms corresponding to an increase in LV dP/dtmax of ≥10%.

Valve Replacement for Severe Aortic Stenosis With Low Transvalvular Gradient and Left Ventricular Ejection Fraction Exceeding 0.50

BACKGROUND Severe aortic stenosis with a low transvalvular gradient and preserved left ventricular ejection fraction (LVEF) is often misdiagnosed, leading to undertreatment of such patients with no clear indication for surgical intervention. This study investigated the outcome of aortic valve replacement (AVR) in patients with severe aortic stenosis and a low transvalvular gradient despite normal LVEF. METHODS Between 1985 and 2008, we evaluated 73 patients who underwent AVR compared with 29 patients who did not. Overall, aortic valve area was 1.0 cm2 or smaller, LVEF was 0.50 or higher, and transvalvular gradient was 30 mm Hg or less. Multivariate and Cox analyses were used to compare these two groups according to AVR. RESULTS Compared with controls, AVR patients were younger and with higher body mass index. Coronary artery bypass grafting was performed simultaneously in 38 AVR patients (52%). At follow-up (median, 42 months; interquartile range, 23 to 75 months), survival was longer in AVR patients. By Cox analysis, AVR remained a major predictor of lower mortality (hazard ratio, 0.237; 95% confidence interval, 0.119 to 0.470; p<0.0001). CONCLUSIONS In patients with severe aortic stenosis and low transvalvular gradient despite a normal LVEF, AVR was associated with significant improvement in long-term survival and functional status and with a low operative mortality.

Prospective analysis of 30-day safety and performance of transfemoral transcatheter aortic valve implantation with Edwards SAPIEN XT versus SAPIEN prostheses.

BACKGROUND A new generation of balloon-expandable valves (e.g. Edwards SAPIEN XT) enables the use of a decreased sheath size using the NovaFlex™ delivery system for transfemoral transcatheter aortic valve implantation (TAVI). However, there are few data analysing the efficacy and safety of this new prosthesis. AIMS To evaluate periprocedural and 30-day clinical outcomes using the Edwards SAPIEN XT compared with the first-generation Edwards SAPIEN prosthesis. METHODS Between May 2006 and October 2011, consecutive high-risk or non-operable patients with severe aortic stenosis had TAVI using an Edwards SAPIEN or SAPIEN XT prosthesis. Valve Academic Research Consortium endpoints were used. RESULTS Of 250 patients who underwent TAVI, 190 were performed transfemorally (78 SAPIEN and 112 SAPIEN XT). Transfemoral access was possible more often using SAPIEN XT (112/123 [91.1%] vs 78/127 [61.4%]; P<0.001). Mean logistic EuroSCORE was significantly lower in the SAPIEN XT group (18.1±11.0% vs 27.3±11.1%; P<0.0001), and the iliofemoral artery minimal lumen diameter was smaller (6.7±1.2 vs 8.5±1.3mm; P<0.0001). Device success was similar in both groups (95.5% for SAPIEN XT and 93.6% for SAPIEN), as was the 30-day combined safety endpoint (15.2% and 17.9%, respectively). At 30days, prosthesis performance was similar in both groups. CONCLUSIONS Short-term safety and performance analysis of the latest generation of balloon-expandable valve, the SAPIEN XT, seem similar to the previous generation. However, transfemoral implantation is more often possible, related to sheath size reduction.