ProGlide-AngioSeal versus ProGlide-FemoSeal for vascular access hemostasis posttranscatheter aortic valve implantation.

BACKGROUND: The hybrid strategy combining plug-based and suture-based vascular closure devices (VCD) was introduced as a promising technique for vascular access hemostasis after transcatheter aortic valve implantation (TAVI) with satisfactory outcomes. However, data comparing two plug-based VCDs each in the combination with a suture-based VCD, namely ProGlide/AngioSeal (P/AS) with ProGlide/FemoSeal (P/FS) VCDs, is still lacking. AIMS: To compare the 30-day outcome of the hybrid strategy using P/AS versus P/FS for vascular access site closure after TAVI. METHODS: A retrospective single-center observational study included 608 patients recruited from a prospective TAVI registry between 2016 and 2022. The composite endpoint was defined as any VCD-related major vascular complications and/or bleeding more than type 1 according to Valve Academic Research Consortium criteria. RESULTS: The current study reported a significantly higher rate of composite endpoint in P/AS group, which was driven by a higher rate of major bleeding (5.4% vs. 1.4%, p = 0.036). We also found a higher rate of VCD-related minor bleeding in P/AS group (16.3% vs. 8.1%, p = 0.013). Successful access site hemostasis was achieved in 71.7% of P/AS group versus 83.1% in P/FS group (p = 0.006). The presence of anterior wall calcification at the access site was significantly associated with the composite endpoint (adj odds ratio 2.49; 95% confidence interval (1.08-5.75), p = 0.032). CONCLUSION: The hybrid strategy for large bore vascular access closure using P/FS showed a potentially better 30-day outcomes compared with P/AS. The presence of anterior calcification at the access site carries a significant risk of VCD-related complications.

Combined rotational atherectomy and cutting balloon angioplasty prior to drug-eluting stent implantation in severely calcified coronary lesions: The PREPARE-CALC-COMBO study.

OBJECTIVES: To evaluate the safety and efficacy of lesion preparation using rotational atherectomy (RA) with consecutive cutting balloon angioplasty (Rota-Cut). BACKGROUND: Whether the Rota-Cut combination improves stent performance in severely calcified coronary lesions is unknown. METHODS: PREPARE-CALC-COMBO is a single-arm prospective trial in which 110 patients were treated with a Rota-Cut strategy before implantation of sirolimus-eluting stents and compared with patients treated with modified balloon (MB, scoring or cutting) or RA from a historical cohort (the randomized PREPARE-CALC trial). The study had two primary endpoints: in-stent acute lumen gain (ALG) by quantitative angiographic analysis and stent expansion (SE) on optical coherence tomography. RESULTS: In-stent ALG was significantly higher with Rota-Cut compared to RA or MB alone (1.92 ± 0.45 mm vs. 1.74 ± 0.45 mm with MB vs. 1.70 ± 0.42 mm with RA; p = 0.001 and p < 0.001, respectively). SE was comparable between groups (75.1 ± 13.8% vs. 73.5 ± 13.3 with MB vs. 73.1 ± 12.2 with RA; p = 0.19 and p = 0.39, respectively). The Rota-Cut combination resulted in higher minimal stent area (MSA) (7.1 ± 2.2mm2 vs. 6.1 ± 1.7mm2  with MB vs. 6.2 ± 1.9mm2 with RA; p = 0.003 and p = 0.004, respectively). In-hospital death occurred in one patient. Target vessel failure at 9 months was low and comparable between groups (8.2% vs. 8% with MB vs. 6% with RA; p = 1 and p = 0.79, respectively). CONCLUSION: Rota-Cut combination resulted in higher ALG and larger MSA compared with historical control of RA or MB alone, but was not associated with higher SE. Despite extensive lesion preparation, this strategy is safe, feasible, and associated with favorable clinical outcome at 9 months.

Long-Term Outcomes after Rotational Atherectomy for Calcified Chronic Total Occlusion versus Nonchronic Total Occlusion Coronary Lesions.

Background: The role of rotational atherectomy (RA) in contemporary percutaneous coronary intervention (PCI) is expanding to include certain chronic total occlusion (CTO) lesions. However, the long-term outcome of RA in CTOs is still unclear. Objective: To investigate in-hospital and long-term outcomes after RA for CTO compared to non-CTO calcified lesions. Moreover, this report evaluates the role of the elective RA approach in calcified CTOs. Methods and Results: This study enrolled 812 patients (869 lesions; CTO, n = 80 versus non-CTO, n = 789). The mean age of the study population was 73.1 ± 8.6 years, the baseline characteristics were comparable in both groups. Balloon-resistant CTO lesions represented the main indication for RA in CTO patients (61.2%). The mean J-CTO score was 2.42 ± 0.95. The angiographic success rate was lower in CTO patients (88.8% vs 94.9%; p = 0.022). In-hospital major adverse cardiac events (MACE) rate was comparable in both groups (CTO 8.8% vs 7.0% in non-CTO;p = 0.557). At two-year follow-up, a higher target lesion failure (TLF) was observed in CTO group (25.5% vs 15.1%, log rank p = 0.041), driven by higher cardiac mortality while the clinically driven target lesion revascularisation (TLR) was comparable between the study groups. Elective RA for CTO had a shorter procedural time and lower rate of dissection (7.5% vs 25%; p = 0.030) compared to bail-out RA with similar long-term outcomes. Conclusion: Compared to non-CTO, RA for CTO can be performed with a high procedural success rate and comparable in-hospital outcomes. Apart from higher cardiac mortality in the CTO group, the long-term outcomes are comparable in both groups. Elective RA is a feasible and beneficial approach to be used in CTO intervention.

Clinical outcomes of single- versus two-stent PCI technique in severely calcified true bifurcation lesions after rotational atherectomy.

BACKGROUND: Severely calcified coronary bifurcations complicate percutaneous coronary interventions (PCI) and often necessitate dedicated lesion preparation. We compared the outcomes of single- versus two-stent techniques for treating heavily calcified true bifurcation lesions following rotational atherectomy (RA). METHODS: Among patients receiving RA for severely calcified true bifurcations at a single center, 59 were treated with a single stent, and another 59 received two stents. We analyzed in-hospital adverse outcomes and 1-year rates of the bifurcation-oriented composite endpoint (BOCE), defined as cardiac death, target bifurcation myocardial infarction (TB-MI), or target bifurcation revascularization (TBR). RESULTS: The single-stent arm was associated with more in-hospital adverse outcomes (adj. OR, 6.13; 95% CI, 1.34-28.0; p = 0.019), driven by higher peri-procedural MI rates (18.6% vs. 5.1%, p = 0.043) and more side branch compromise (13.6% vs. 0%, p = 0.006). After 1 year, both techniques had comparable 1-year BOCE (adj. HR, 0.38; 95% CI, 0.12-1.23; p = 0.106). We observed a significant interaction between the treatment technique and the presence of LM bifurcation (p interaction = 0.012), favoring single-stent technique in patients with non-LM bifurcations (HR 0.14, 95% CI 0.03-0.68; p = 0.015). Notably, the single-stent technique had lower rates of TBR (2% vs. 15%, p log-rank = 0.026) after 1 year. CONCLUSION: Patients with severely calcified true bifurcation lesions, treated with RA followed by a single stent implantation, had more in-hospital adverse outcomes compared to those treated with two stents. However, the superior outcomes of the two-stent technique did not translate into improved long-term results. In fact, the two-stent technique was even associated with higher rates of revascularization after 1 year.

Ten-year Durability, Hemodynamic Performance, and Clinical Outcomes after Transcatheter Aortic Valve Implantation Using a Self-expanding Device.

INTRODUCTION: The expansion of transcatheter aortic valve implantation (TAVI) to low-risk and younger patients has increased the relevance of the long-term durability of transcatheter heart valves (THV). The present study aims to assess the 10-year durability, hemodynamic performance, and clinical outcomes after TAVI using the CoreValve system. METHODS: An analysis from a prospective registry with predefined clinical and echocardiographic follow-up included 302 patients who underwent TAVI with the CoreValve system between 2007 and 2015. Bioprosthetic valve failure (BVF) was defined as any bioprosthetic valve dysfunction-related death, re-intervention, or severe hemodynamic valve deterioration. RESULTS: At the time of TAVI, the mean age was 80.41 ± 7.01 years, and the Society of Thoracic Surgeons (STS) score was 6.13 ± 5.23%. At latest follow-up (median [IQR]: 5 [2-7] years), cumulative all-cause mortality rates at 3, 5, 7, and 10 years was 23.7%, 40%, 65.8%, and 89.8%, respectively. Mean aortic valve area and transvalvular gradient post-TAVI and at 5, 7, and 10 years were 1.94, 1.87, 1.69, and 1.98 cm2 (p = 0.236) and 8.3, 9.0, 8.2, and 10.1 mmHg (p = 0.796), respectively. Overall, 11 patients had BVF, of whom six had structural valve deterioration (SVD). The 10-year actual and actuarial freedom from BVF was 96.1% and 78.8%, and from SVD was 97.9% and 80.9%, respectively. Three patients developed significant non-SVD due to severe paravalvular leakage, and two patients were diagnosed with infective endocarditis. CONCLUSION: Using an early-generation self-expanding bioprosthesis, we documented durable hemodynamic performance and low rates of BVF and SVD up to 10 years after TAVI.

Incidence, characteristics, and outcome of noncardiac surgery following transcatheter aortic valve implantation.

BACKGROUND: Planning noncardiac surgery after transcatheter aortic valve implantation (TAVI) is challenging. We evaluated the incidence, characteristics, and outcome of noncardiac surgeries in patients who underwent TAVI. METHODS: We retrieved data from the Prospective Segeberg TAVI registry of all patients who received TAVI between 2007 and 2020. Type, timing, urgency, and risk of noncardiac surgery were assessed. We evaluated the patients' clinical outcomes within 30 days following noncardiac surgery that included death, myocardial infarction, bleeding, stroke, and acute heart failure. A composite outcome of all adverse events was proposed to independently predict 30 day adverse events. RESULTS: Among 1602 patients, 104 patients (mean age, 79.9 ± 7.14 years; 61 (58.7%) females) underwent 148 noncardiac surgeries after TAVI. More than half of the noncardiac surgeries were considered elective (n = 84, 56.7%). Procedures were categorized into low-risk (n = 27, 18.2%), intermediate-risk (n = 102, 68.9%), and high-risk (n = 19, 12.8%) surgery. The composite outcome of adverse events occurred after 57 noncardiac surgeries (38.5% of all procedures) and after more than half of the surgeries in the high-risk group (n = 11, 57.9%). Major or life-threatening bleeding occurred in 24 noncardiac surgeries (19.1%) and was more frequent in high-risk surgeries than in low- and intermediate-risk surgeries (36.8%, p < 0.047). High-risk category of surgery was independently associated with increased risk of the composite outcome (adjusted OR, 3.99; 95% CI 1.12-14.23; p = 0.033). CONCLUSION: Noncardiac surgery after TAVI was performed in 6.5% patient of our study cohort. High-risk noncardiac surgeries were associated with increased risk of adverse events.

Predictors of long-term adverse outcomes after successful chronic total occlusion intervention: physiology or morphology?

BACKGROUND: Quantitative flow ratio (QFR) and target-vessel SYNTAX score (tvSS) are novel indices used to assess lesion physiology and morphology in percutaneous coronary intervention (PCI). Their prognostic implication after successful recanalization of coronary chronic total occlusion (CTO) is unknown. OBJECTIVES: To investigate the prognostic value of QFR measured immediately after successful CTO-recanalization in predicting vessel-oriented adverse events, and to compare it with the pre-procedural morphological tvSS. METHODS: QFR was measured offline after successful CTO-PCIs in a single center. We grouped the patients according to a cut-off value of post-PCI QFR (0.91). The primary outcome was target-vessel failure (TVF) at 2 years. RESULTS: Among 470 CTO lesions performed during the study period, 324 were eligible for QFR analysis (258 with QFR ≥ 0.91 and 66 with QFR < 0.91). The mean age of the study population was 68.3 ± 10.7 years. The low QFR group had a lower left ventricular ejection fraction (45.8 ± 13.9% vs. 49.8 ± 12.4%, p = 0.025) and a higher rate of atrial fibrillation (19.7% vs. 11.2%, p = 0.020). The mean tvSS was 12.8 ± 4.8, and it showed no significant difference in both groups (13.6 ± 5.1 vs. 12.6 ± 4.6, p = 0.122). Patients with low post-CTO QFR had a trend to develop more TVF at 2 years (21.2% vs. 12.4%, HR 1.74; 95% CI 0.93-3.25, p = 0.086). Low post-CTO QFR failed to predict 2-year TVF (aHR 1.67; 95% CI 0.85-3.29, p = 0.136), while pre-procedural tvSS was an independent predictor for 2-year TVF (aHR 1.06; 95% CI 1.01-1.13, p = 0.030). CONCLUSION: We found a limited prognostic value of immediate physiological assessment using QFR after successful CTO intervention. Pre-procedure morphological characteristics of CTO lesions using tvSS can play a role in predicting long-term adverse events.

The Target Vessel SYNTAX Score: A Novel Pre-Procedural Predictor for Contrast-Induced Acute Kidney Injury After Rotational Atherectomy.

BACKGROUND: Rotational atherectomy (RA) is a complex procedure often associated with high contrast load. Known risk scores do not predict contrast-induced acute kidney injury (CI-AKI) before RA. We aim to investigate pre-procedural predictors of CI-AKI after RA, and the role of the target vessel SYNTAX score (tvSS). METHODS: Among 295 patients who underwent RA between 01.2010 and 02.2019 at a single center, 49 developed CI-AKI. Those who were on chronic hemodialysis or with no available 48-h' kidney function tests were excluded. Predictors of CI-AKI were assessed in the whole cohort and those with no basal renal impairment. RESULTS: The rate of CI-AKI was 16.6 %. The tvSS was 18 [14-23] vs. 12 [9-18] in patients with vs. without CI-AKI (p < 0.001). The tvSS cut-off value of 15 provided 75 % sensitivity and 60 % specificity for predicting CI-AKI. Consequently, a tvSS ≥15 emerged as an independent pre-procedural predictor for CI-AKI (adjusted OR: 4.94, 95 % CI: 2.38-10.20, p < 0.001), along with left ventricular ejection fraction (LVEF) ≤35 % (p = 0.016) and glomerular filtration rate (GFR) <45 ml/min (p = 0.004). TvSS was the only independent pre-procedural predictor for CI-AKI in patients with GFR ≥60 ml/min (p < 0.001). The contrast volume/GFR ratio and peri-procedural myocardial infarction (MI) were independent procedural predictors for CI-AKI in the whole cohort and in patients with basal GFR ≥60 ml/min. CONCLUSION: CI-AKI after RA is frequent. The tvSS is an efficient pre-procedural predictor for CI-AKI after RA, along with LVEF ≤35 % and GFR <45 ml/min. Contrast volume/GFR ratio and peri-procedural MI emerged as procedural predictors for CI-AKI.

Rotational atherectomy of calcified coronary lesions: current practice and insights from two randomized trials.

With growing experience, technical improvements and use of newer generation drug-eluting stents (DES), recent data showed satisfactory acute and long-term results after rotational atherectomy (RA) in calcified coronary lesions. The randomized ROTAXUS and PREPARE-CALC trials compared RA to balloon-based strategies in two different time periods in the DES era. In this manuscript, we assessed the technical evolution in RA practice from a pooled analysis of the RA groups of both trials and established a link to further recent literature. Furthermore, we sought to summarize and analyze the available experience with RA in different patient and lesion subsets, and propose recommendations to improve RA practice. We also illustrated the combination of RA with other methods of lesion preparation. Finally, based on the available evidence, we propose a simple and practical approach to treat severely calcified lesions.

Lithoplasty-Facilitated Proximal Cap Penetration of a Calcified Chronic Total Occlusion Coronary Lesion.

We present a case of calcified chronic total occlusion of the left anterior descending coronary artery with ambiguous cap at the bifurcation with a large diagonal branch, in which intravascular lithoplasty balloon was used to modify the calcified proximal cap and facilitate wire crossing. (Level of Difficulty: Advanced.).

Prognostic Value of HFA-PEFF Score in Patients Undergoing Transcatheter Aortic Valve Implantation.

Background The HFA-PEFF score may help in predicting long-term outcomes in patients undergoing transcatheter aortic valve implantation (TAVI) for severe aortic stenosis and preserved left ventricular ejection fraction (EF). Methods We retrieved data from 1,332 patients undergoing TAVI between 2010 and 2019 from the Prospective Segeberg TAVI Registry (ClinicalTrials.gov Identifier: NCT03192774). We calculated the HFA-PEFF score for 1,022 patients who had preserved EF (≥50%). To assess the prognostic value of the HFA-PEFF score in predicting adverse events, we dichotomised the patients according to a cut-off score of five (score <5 group: n=528 (51.6%), score ≥5 group: n=494 (48.3%)). Results The HFA-PEFF score ≥5 groups were older (81.9±6.3 years vs. 80.3±6.9 years; p<0.001) and had a higher prevalence of atrial fibrillation (35.1% vs 20.8%; p<0.001) and chronic kidney disease (30.1% vs 26.1%; p<0.001). Kaplan-Meier survival analyses over 24 months showed increased cardiovascular (CV) mortality (12.5% vs. 7.7%, log-rank; p=0.028) and first heart failure-related rehospitalisation (7.7% vs. 4.0%, log-rank p=0.014) in the HFA-PEFF score ≥5 groups compared with those of lower scores. No significant difference in all-cause mortality between both groups was observed (22.0% vs. 17.9%, log-rank p=0.127). In multivariate analysis, HFA-PEFF score ≥5 failed to predict CV mortality (aHR 1.37, 95% CI: 0.90-2.08, p=0.140) and time to first heart failure-related rehospitalisation (aHR 1.49, 95% CI: 0.83-2.65, p=0.181). Conclusion The HFA-PEFF score showed limited value in predicting long-term mortality and adverse heart failure-related events in patients with preserved EF undergoing TAVI. Clinical variables specific to this population could complement the HFA-PEFF score for better risk prediction.

Complex vs. non-complex percutaneous coronary intervention with newer-generation drug-eluting stents: an analysis from the randomized BIOFLOW trials.

BACKGROUND: Patients undergoing complex percutaneous coronary intervention (PCI) are at higher risk of adverse outcomes, but data are scarce in the era of newer-generation coronary stents. AIM: We sought to compare the clinical outcomes after complex PCI with a bioresorbable-polymer sirolimus-eluting stent (BP-SES) versus a durable-polymer everolimus-eluting stent (DP-EES). METHODS: Patients (n = 2350) from BIOFLOW-II, -IV, and -V randomized trials were categorized into non-complex PCI vs. complex PCI. Complex PCI had at least one of the following criteria: multi-vessel PCI, ≥ 3 lesions treated, ≥ 3 stents implanted, total stent length ≥ 60 mm. Endpoints were target lesion failure (TLF: cardiac death, target-vessel myocardial infarction [TV-MI], or target lesion revascularization [TLR]) and probable/definite stent thrombosis (ST) at three years. RESULTS: Patients with complex PCI (n = 348) were older and presented more often with acute coronary syndrome than non-complex PCI patients (n = 2002). Complex PCI lesions were more often type B2/C and bifurcation lesions and required more pre- and post-dilatation. Complex PCI patients had higher rates of TLF (14.6% vs. 8.1%; aHR 1.89, 95% CI [1.31-2.73], p = 0.001), TV-MI (10.2% vs. 4.4%, aHR 2.17, 95% CI [1.40-3.37], p = 0.001), and ST (1.5% vs. 0.4%, p = 0.025) as compared with non-complex PCI. TLF was not lower with BP-SES as compared to DP-EES in complex PCI (12.6% vs 18.2%, p = 0.16). CONCLUSION: Patients undergoing complex PCI with the newer-generation DES still sustain a higher risk of TLF, TV-MI and stent thrombosis as compared with non-complex PCI. This adverse outcome was not significantly modified by the stent platform (BP-SES vs. DP-EES). CLINICAL TRIAL REGISTRATION: Clinicaltrial.gov NCT01356888, NCT01939249, NCT02389946, https://clinicaltrials.gov/show/NCT01356888 ; https://clinicaltrials.gov/show/NCT01939249 ; https://clinicaltrials.gov/show/NCT02389946 .

Imaging-Guided Transcatheter Aortic Valve Replacement and Percutaneous Coronary Intervention in Decompensated Severe Aortic Stenosis with Acute Renal Impairment.

An 82-year-old woman with severe aortic valve stenosis (AS) and a significant proximal right coronary artery (RCA) stenosis presented with decompensated heart failure and acute kidney injury. She was treated with intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI) and trans-oesophageal echocardiography (TOE)-guided transcatheter aortic valve replacement (TAVR).

Feasibility and safety of minimal-contrast IVUS-guided rotational atherectomy for complex calcified coronary artery disease.

OBJECTIVES: To assess the feasibility and safety of minimal-contrast percutaneous coronary intervention (PCI) using rotational atherectomy (RA) in patients with severe coronary calcification at high-risk of contrast-associated acute kidney injury (AKI). METHODS: Twenty-six patients with advanced chronic kidney disease undergoing PCI with RA at three high-volume centres were included. Baseline intravascular ultrasound (IVUS) was performed to assess lesion morphology, and to guide burr-, balloon-, and stent-selection. Final result was assessed by IVUS and angiographically. Feasibility and safety were determined by procedural and in-hospital complications, and efficacy was assessed by freedom from contrast-associated AKI after PCI. Procedural and in-hospital outcome was compared to a propensity-matched population of standard RA PCI. RESULTS: Mean glomerular filtration rate was 32 ± 17 ml/min/1.73 m2. In seven cases PCI was performed in the setting of acute coronary syndrome. The left main coronary artery was treated in 27.8% and a two-stent bifurcation technique in 44.4%. RA was more often performed electively compared to the standard RA cohort (92.3 vs. 50%; p = 0.0016). Angiographic success was achieved in 100% and documented with a median contrast amount of 12.5 ml [Range 4-43]. No in-hospital death or myocardial infarction was reported. Contrast-associated AKI occurred in one patient versus five patients in standard RA group (p = 0.19). Shorter fluoroscopy time and lower radiation dose were achieved as compared to standard RA. CONCLUSION: A minimal-contrast RA approach with IVUS-guidance for treatment of complex calcified coronary lesions is feasible and safe with high success rate.