Anna Piccoli

Functional Assessment of Coronary Artery Disease in Patients Undergoing Transcatheter Aortic Valve Implantation: Influence of Pressure Overload on the Evaluation of Lesions Severity

Background—Aortic valve stenosis may influence fractional flow reserve (FFR) of concomitant coronary artery disease by causing hypertrophy and reducing the vasodilatory reserve of the coronary circulation. We sought to investigate whether FFR values might change after valve replacement. Methods and Results—The functional relevance of 133 coronary lesions was assessed by FFR in 54 patients with severe aortic valve stenosis before and after transcatheter aortic valve implantation (TAVI) during the same procedure. A linear mixed model was used to verify the interaction of TAVI effect with the FFR values. No significant overall change in FFR values was found before and after the aortic valve stenosis removal (0.89±0.10 versus 0.89±0.13; P=0.73). A different trend in FFR groups (positive if ⩽0.8; negative if >0.8) was found after TAVI (P for interaction <0.001). Positive FFR values worsened after TAVI (0.71±0.11 versus 0.66±0.14). Conversely, negative FFR values improved after TAVI (0.92±0.06 versus 0.93±0.07). Similarly, FFR values in coronary arteries with lesions presenting percent diameter stenosis >50 worsened after TAVI (0.84±0.12 versus 0.82±0.16; P=0.02), whereas FFR values in arteries with mild lesions (percent diameter stenosis <50) tended toward improvement after TAVI (0.90±0.07 versus 0.91±0.09; P=0.69). Functional FFR variations after TAVI changed the indication to treat the coronary stenosis in 8 of 133 (6%) lesions. Conclusions—Coronary hemodynamics are influenced by aortic valve stenosis removal. Nevertheless, FFR variations after TAVI are minor and crossed the diagnostic cutoff of 0.8 in a small number of patients after valve replacement. Borderline coronary lesions might become functionally significant after valve replacement, although FFR-guided interventions were infrequent even in patients with angiographically significant lesions.

Clinical outcomes of transcatheter aortic valve implantation: from learning curve to proficiency

Objective The use of transcatheter aortic valve implantation (TAVI) is growing rapidly in countries with a predominantly elderly population, posing a huge challenge to healthcare systems worldwide. The increment of human and economic resource consumption imposes a careful monitoring of clinical outcomes and cost-benefit balance, and this article is aimed at analysing clinical outcomes related to the TAVI learning curve. Methods Outcomes of 177 consecutive transfemoral TAVI procedures performed in 5 years by a single team were analysed by the Cumulative Sum of failures method (CUSUM) according to the clinical events comprised in the Valve Academic Research Consortium (VARC-2) safety end point and the VARC-2 definition of device success. Margins for events acceptance were extrapolated from landmark trials that tested both balloon or self-expandable percutaneous valves. Results 30-day and 1-year survival rates were 97.2% and 89.9%, respectively. Achievement of the primary end point (number of cases needed to provide the acceptable margin of the composite end point of any death, stroke, myocardial infarction, life-threatening bleeding, major vascular complications, stage 2–3 acute kidney injury and valve-related dysfunction requiring a repeat procedure) required the performance of 54 cases, while the learning curve to achieve ‘device success’ identified 32 cases to reach the expected proficiency. In this experience, the baseline clinical risk as assessed by the Society of Thoracic Surgeons (STS) score determined the long-term survival rather than the adverse events related to the learning curve. Conclusions A relatively large number of cases are required to achieve clinical outcomes comparable to those reported in high-volume centres and controlled trials. According to our national workload standards, this represents more than 2 years of continuous activity.

Coronary Catheterization and Percutaneous Interventions After Transcatheter Aortic Valve Implantation

Coronary artery disease (CAD) is often present in patients with severe aortic valve stenosis candidates to transcatheter aortic valve implantation (TAVI). Mild CAD may also worsen and need treatment years after TAVI. The implantation of a transcatheter valve may interfere with the capability of reengaging the coronary arteries. We prospectively assessed the feasibility of performing coronary angiography (CA), fractional flow reserve, and, where indicated, percutaneous coronary intervention after valve implantation in a consecutive series of patients with CAD undergoing TAVI. Valve type and size were decided according to accurate computed tomography scan and angiographic measurement of the aortic root structures. We analyzed 66 consecutive patients undergoing TAVI, 41 with balloon-expandable, and 25 with self-expandable transcatheter valves. Right and left coronary catheterization (132 vessels) was successful in all cases except in 1 left coronary artery after a high implantation of a self-expandable valve (unsuccess rate, 1 in 50 vessels). In 6 of 132 vessels (4%), CA was initially nonselective, but after positioning the 0.014″ intracoronary guidewire, selective injections were obtained in all these cases. Percutaneous coronary intervention was performed successfully in 19 coronary vessels (17 patients) as indicated by fractional flow reserve measurements. In conclusion, catheterization of the coronary ostia after transfemoral TAVI with balloon or self-expandable valves is safe and feasible in almost all cases. Accurate imaging of the aortic root and procedural planning may help to avoid too high implantation of supra-annular self-expandable valves to obviate difficulties in accessing coronary ostia. Use of intracoronary guidewires facilitates selective CA in cases with difficult access.

iFR-FFR comparison in daily practice: a single-center, prospective, online assessment.

Aims To compare the performance of instantaneous wave-free ratio (iFR) with fractional flow reserve (FFR) in a real-life, prospective, single-center, and independent study. Methods and results Fifty-four patients were included and 89 angiographic intermediate lesions underwent functional evaluation with both iFR and FFR. FFR was used as the gold standard, and the patients having FFR values 0.80 or less only underwent percutaneous coronary intervention. Linear regression demonstrated close agreement between the two techniques (R = 0.83, P < 0.0001). Receiver operator characteristic analysis confirmed the strong correlation, with an area under the curve approximately equal to unity. iFR detected ischemia with a sensitivity and specificity of 100 and 87%, respectively, thus revealing a positive predictive value of 78% and a negative predictive value of 100%. In addition, according to FFR assessment, percutaneous coronary intervention was performed on 39 lesions (43.8%) in 27 patients (50%), whereas positive iFR values were found in 52 lesions (+14.6% compared with FFR). At clinical follow-up (ranging from 6 to 16 months), all patients remained asymptomatic and none of them experienced major adverse cardiovascular events. Conclusions In this independent, online, comparison of iFR-FFR values in patients with angiographic intermediate lesions, results are consistent with those derived from previous offline controlled trials, and support the correlation between iFR and FFR in daily clinical practice.

Physiologic evaluation of coronary lesions using instantaneous wave-free ratio (iFR) in patients with severe aortic stenosis undergoing transcatheter aortic valve implantation

AIMS We sought to assess eventual changes in iFR measurements in patients with aortic stenosis (AS) before and after TAVI in coronary lesions with different degrees of angiographic severity. METHODS AND RESULTS The functional relevance of 145 coronary lesions was assessed by online iFR and FFR measurement in 66 patients with severe AS before and after TAVI, during the same procedure. The iFR-FFR classification agreement was calculated for pre-TAVI and post-TAVI measurements. Mean iFR values remained identical before and after TAVI, irrespective of the angiographic severity of the coronary stenosis (0.89±0.12 vs. 0.89±0.12, p=0.66). However, individual iFR values varied widely after TAVI and the 0.89 iFR threshold was crossed by 15% of the investigated coronary lesions. Higher iFR variation was related to a higher transaortic gradient drop after valve intervention. The diagnostic accuracy of iFR in predicting an FFR ≤0.8 was poor (65%) in lesions with severe obstructions, and tended to increase post TAVI. CONCLUSIONS Although overall values did not change after TAVI, iFR presented significant and mostly erratic individual variations after valve replacement. Delta iFR was influenced by the extent of the transaortic gradient drop induced by TAVI. Therefore, caution is advisable in the interpretation of iFR in the presence of AS.

Coronary physiology in patients with severe aortic stenosis: Comparison between fractional flow reserve and instantaneous wave-free ratio

BACKGROUND The functional assessment of coronary artery disease (CAD) in patients with aortic stenosis (AS) has not been validated so far, and the best strategy to physiologically investigate the relevance of coronary stenosis in this specific setting of patients remains undetermined. The aim of the study is to compare the diagnostic performance of instantaneous wave-free ratio (iFR) and fractional flow reserve (FFR) in patients with severe AS. METHODS The functional significance of 179 coronary lesions was investigated with on-line iFR and FFR measurements in 85 AS patients and compared with a control group formed by 167 patients (290 lesions) with stable CAD and without AS. The iFR-FFR diagnostic agreement has been tested using the conventional 0.80 FFR cut-off. RESULTS The correlation between iFR and FFR was similar between AS and CAD patients, as well as the area under the curve at ROC curve analysis (0.97 vs 0.96, p=0.88). However, using the standard iFR 0.89 threshold, the diagnostic accuracy of iFR was significantly lower in AS compared with CAD (76.3% vs 86.1%, p=0.009). According to ROC analysis, the best iFR cut-off in predicting FFR≤0.8 was lower in AS (0.83, J=0.82) compared with CAD (0.89, J=0.81). Using the ROC derived cut-off of 0.83, the iFR accuracy increased significantly (91.3%, p=0.003) while maintaining an elevated negative predictive value (95.5%). CONCLUSIONS In the presence of severe AS, conventional iFR cut-off had lower diagnostic agreement with FFR classification of coronary lesions compared to stable CAD patients. AS seems to influence iFR cut-off ischemic thresholds and deserves further comparative studies.

Expanding TAVI options: elective rotational atherectomy during trans-catheter aortic valve implantation.

Aortic valve stenosis (AVS) in the elderly is frequently associated to coronary artery disease (CAD). In patients with significant coronary stenosis surgical valve replacement is associated to coronary bypass grafting, but whether coronary angioplasty is needed in patients receiving trans-catheter aortic valve implantation (TAVI) is unknown. Given the frequent complexity of CAD in the elderly with calcific AVS, rotational atherectomy (RA) may be needed in some cases. No data are available about feasibility and safety of RA during TAVI. The need for myocardial revascularization in TAVI candidates is discussed, and a series of RA cases performed during TAVI is described.

Clinical outcomes of secondary prevention strategies for young patients with cryptogenic stroke and patent foramen ovale

Abstract Background The aim of this study was to compare the immediate and long-term clinical outcomes of medical therapy and percutaneous patent foramen ovale (PFO) closure as secondary prevention strategies in patients younger than 55 years of age presenting with cryptogenic stroke and PFO. Methods Between January 2006 and April 2015, all patients with the diagnosis of cryptogenic stroke and PFO were analysed and prospectively followed. Stroke was confirmed in 159 out of 309 patients (51%). In the remaining cases, other neurological conditions were found and therefore excluded from further analysis. Patients received PFO closure or medical therapy on the basis of a pre-specified algorithm. Primary outcome was the assessment of recurrent ischaemic events at follow-up. Results Percutaneous PFO closure was performed in 77 patients (48%) and 82 (52%) were treated medically. Mean follow-up was 51.6 ± 34.8 months. Two ischaemic strokes occurred in the medical group only (2.4% vs 0%; P = 0.16) and no complications related to the invasive procedure were observed. Conclusions The diagnosis of stroke in patients with PFO could be confirmed in 50% of cases only, underlining the importance of a multidisciplinary evaluation of these patients. A very low ischaemic recurrence rate was observed in the medical therapy group, suggesting that a personalized treatment based on a prespecified diagnostic algorithm yields good clinical results irrespective of the treatment modality. Given the low number of recurrences, larger cohorts may be needed to prove significant differences.

Effectiveness and Safety of Transcatheter Aortic Valve Implantation in Patients With Pure Aortic Regurgitation and Advanced Heart Failure

Results of transcatheter aortic valve implantation (TAVI) for treatment of severe noncalcific isolated aortic regurgitation (AR) complicated by advanced heart failure or cardiogenic shock has been previously reported only in isolated case reports. Current self-expanding transcatheter aortic valves are designed to treat aortic valve stenosis, and have also been implanted in cases of severe AR due to degenerated bioprosthesis and in very few cases of native aortic valves. We report 13 consecutive inoperable patients with noncalcific, pure AR, and advanced heart failure treated with emergency percutaneous transfemoral implantation with self-expandable CoreValves at our institution between July 2012 and September 2017. The immediate and long-term clinical outcome was prospectively assessed according to the Valve Academic Research Consortium-2 criteria for device success and safety. All but 3 patients had previous surgery of the aortic root, including 2 implants of Heart Mate-II left ventricle assist device; none had surgical aortic bioprosthesis at the time of the TAVI. Valve implantation was successful in 12 of 13 patients (92%) and 1 patient required a second unplanned valve procedure within 18 hours. Oversizing the prosthesis by approximately 15% yielded better results with 1 valve. Two patients with left ventricle assist device died within 30 days of TAVI. All patients who survived to hospital discharge had none or just mild residual AR, improved their cardiac function, and survived at long-term without recurrence of clinical events. In conclusion, implanting self-expandable transcatheter valves in patients pure AR in this small study was safe and effective, and represented an important option for inoperable patients with noncalcific severe AR.

TCT-384 Contrast-Induced Acute Kidney Injury and Persistent Renal Damage: Early Predictors after Coronary Angiography and Interventions

TCT-384 Contrast-Induced Acute Kidney Injury and Persistent Renal Damage: Early Predictors after Coronary Angiography and Interventions Gabriele Pesarini, Roberto Scarsini, Silvia Maggio, Anna Piccoli, Annachiara Benini, Carlo Zivelonghi, Corrado Vassanelli, Flavio Ribichini Ospedale Civile Maggiore Borgo Trento, Verona, Italy; University of Verona; AOUI Verona, Verona, Verona, Italy; Athens Medical School, Hippokration Hospital; Erasmus MC; Azienda ospedaliera universitaria di Verona, Verona, Venice, Italy; University of Verona, Verona, Venice, Italy; Università di Verona, Verona, Italy