Cardiac Reoperation or Transcatheter Mitral Valve Replacement for Patients With Failed Mitral Prostheses.

BACKGROUND: Evidence is limited regarding patient outcomes comparing redo surgical mitral valve replacement (redo SMVR) vs transcatheter mitral valve replacement (TMVR) for failed prostheses. OBJECTIVES: The goal of this study was to compare the outcomes of redo SMVR vs TMVR in patients with failed prostheses, as well as evaluate the association between case volume and outcomes. METHODS: Medicare beneficiaries aged ≥65 years who underwent redo SMVR or TMVR for failed mitral prostheses between 2016 and 2020 were included. The primary endpoint was mid-term (up to 3 years) major adverse cardiovascular events (MACE), including all-cause death, heart failure rehospitalization, stroke, or reintervention. Propensity score-matched analysis was used. RESULTS: A total of 4,293 patients were included (redo SMVR: 64%; TMVR: 36%). TMVR recipients were older, with a higher comorbidity burden. In matched cohort (n = 1,317 in each group), mid-term risk of MACE was similar (adjusted HR: 0.92; 95% CI: 0.80-1.04; P = 0.2). However, landmark analysis revealed a lower risk of MACE with TMVR in the first 6 months (adjusted HR: 0.75; 95% CI: 0.63-0.88; P < 0.001) albeit with a higher risk beyond 6 months (adjusted HR: 1.28; 95% CI: 1.04-1.58; P = 0.02). Increasing procedural volume was associated with decreased risk of mid-term MACE after redo SMVR (P = 0.001) but not after TMVR (P = 0.3). CONCLUSIONS: In this large cohort of Medicare beneficiaries with failed mitral prostheses, outcomes were similar between redo SMVR and TMVR at 3 years, with TMVR showing a lower initial risk but a higher risk of MACE after 6 months. These findings highlight the importance of striking a balance between surgical risk, anticipated longevity, and hospital expertise when selecting interventions.

Long-Term Intracoronary Structural and Vasomotor Assessment of the ABSORB Bioresorbable Vascular Scaffold.

We systematically categorized the longer-term (≥3 years) structural and functional characteristics of the ABSORB bioresorbable vascular scaffold (BVS) using optical coherence tomography imaging and coronary vasomotor reactivity testing and further compared the functional characteristics of BVS stented versus remote coronary segments. A total of 92 patients (mean age 56.4 ± 9.7 years, 22.8% women) who underwent percutaneous coronary intervention (76% with acute coronary syndrome) using the ABSORB BVS (112 lesions) were included. Optical coherence tomography analysis (38,790 visible struts) comprised in-segment quantitative lumen/plaque and semiquantitative plaque composition analysis of the neointimal pattern. Epicardial endothelium-dependent and-independent vasomotion was defined as any vasodilatation at low/intermediate intracoronary dose of acetylcholine (ACh) and nitroglycerine, assessed using quantitative coronary angiography. At a median time of 3.2 years follow-up, 79.8% of BVS segments still demonstrated visible struts with a predominant neointimal fibrotic healing pattern in 84% of BVS segments, with 99.5% of struts demonstrating coverage with apposition. Compared with remote segments, BVS segments demonstrated less endothelium-dependent vasodilatation at low (p = 0.06) and intermediate ACh doses (p = 0.04). Hypertension, longer time interval from index percutaneous coronary intervention, and the degree of in-BVS segment neointimal volume (p <0.03 for all) were each independently associated with abnormal BVS endothelium-dependent vasomotor function. Endothelium-independent function was more likely preserved in non-BVS (remote) segments compared with BVS segments (p = 0.06). In conclusion, at 3+ years post-ABSORB BVS insertion, the rate of complete scaffold resorption was low and residual strut presence was high, with a dominant fibrous healing response contributing toward neointimal hyperplasia and endothelium-dependent and-independent vasomotor dysfunction.

Diagnostic performance and prognostic impact of coronary angiography-based Index of Microcirculatory Resistance assessment: A systematic review and meta-analysis.

BACKGROUND: The Index of Microcirculatory Resistance (IMR), measured with a pressure-thermistor tipped coronary guidewire has been established as a gold standard for coronary microvascular assessment. Angiography-based IMR (angio-IMR) is a novel method to derive IMR without intracoronary instrumentation or the need for adenosine. METHODS: PubMed and Embase databases were systemically searched in November 2021 for studies that measured angio-IMR. The primary outcomes were pooled sensitivity and specificity as well as the area under the curve (AUC) of the summary receiver operating characteristic curve using IMR as a reference standard. RESULTS: A total of 129 records were initially identified and 8 studies were included in the final analysis. Overall, 1653 lesions were included in this study, of which 733 were in patients presenting with ST-segment elevation myocardial infarction. Angio-IMR yielded high diagnostic performance predicting wire-based IMR with pooled sensitivity = 0.81 (95% confidence interval: 0.76, 0.85), specificity = 0.80 (0.72, 0.86), and AUC = 0.86 (0.82, 0.88), which was similar irrespective of patient presentation. When the clinical outcome was compared between high versus low angio-IMR in patients presenting with myocardial infarction, high angio-IMR predicted an increased risk of major adverse cardiac events (MACE). CONCLUSION: Our study found that coronary angio-IMR has relatively high diagnostic performance as well as prognostic values predicting MACE, supporting its use in clinical practice.

Coronary physiologic assessment based on angiography and intracoronary imaging.

Despite the current evidence supporting clinical benefits of fractional flow reserve (FFR), its uptake in the cardiac catheterization laboratory has been slow due to procedural cost and increased time with the need for maximum hyperemia. Recently, novel physiological indices derived from coronary angiography and intracoronary imaging have emerged to overcome issues with a wire-based FFR. Angiography-based FFR can be measured without vessel instrumentation and has shown excellent diagnostic performance using wire-based FFR as the reference standard. Thus, angiography-based FFR may facilitate coronary functional assessment before and after percutaneous coronary intervention (PCI). Angiography-based index of microcirculatory resistance (IMR) is another new computational index for assessing the coronary microcirculation. Although angiography-derived IMR remains in an early phase of development and requires further validation, its less-invasive nature may help broaden the adoption of microvascular functional assessment in various conditions such as myocardial infarction and cardiac allograft vasculopathy. Lastly, computational FFR based on intravascular ultrasound and optical coherence tomography allows detailed lesion assessment from both morphological and functional standpoints. Given a growing interest in physiology-guided PCI optimization strategies, intravascular imaging-based FFR may become the main assessment tool to confirm successful PCI.

Incidence, Management, Immediate and Long-Term Outcome of Guidewire and Device Related Grade III Coronary Perforations (from G3CAP - Cardiogroup VI Registry).

Ellis grade III coronary artery perforations (G3-CAP) remain a life-threatening complication of percutaneous coronary intervention (PCI), with high morbidity and mortality and lack of consensus regarding optimal treatment strategies. We reviewed all PCIs performed in 10 European centers from 1993 to 2019 recording all G3-CAP along with management strategies, in-hospital and long-term outcome according to Device-related perforations (DP) and Guidewire-related perforations (WP). Among 106,592 PCI (including 7,773 chronic total occlusions), G3-CAP occurred in 311 patients (0.29%). DP occurred in 194 cases (62.4%), more commonly in proximal segments (73.2%) and frequently secondary to balloon dilatation (66.0%). WP arose in 117 patients (37.6%) with chronic total occlusions guidewires involved in 61.3% of cases. Overall sealing success rate was 90.7% and usually required multiple maneuvers (80.4%). The most commonly adopted strategies to obtain hemostasis were prolonged balloon inflation (73.2%) with covered stent implantation (64.4%) in the DP group, and prolonged balloon inflation (53.8%) with coil embolization (41%) in the WP group.  Procedural or in-hospital events arose in 38.2% of cases: mortality was higher after DP (7.2% vs 2.6%, p = 0.05) and acute stent thrombosis 3-fold higher (3.1% vs 0.9%, p = 0.19). At clinical follow-up, median 2 years, a major cardiovascular event occurred in one-third of cases (all-cause mortality 8.2% and 7.1% respectively, without differences between groups). In conclusion, although rare and despite improved rates of adequate perforation sealing G3-CAP cause significant adverse events. DP and WP result in different patterns of G3-CAP and management strategies should be based on this classification.

Value of Echocardiographic Right Ventricular and Pulmonary Pressure Assessment in Predicting Transcatheter Tricuspid Repair Outcome.

OBJECTIVES: The aim of this study was to assess the value of echocardiographic right ventricular (RV) and systolic pulmonary artery pressure (sPAP) assessment in predicting transcatheter tricuspid edge-to-edge valve repair (TTVR) outcome. BACKGROUND: RV dysfunction and pulmonary hypertension are associated with poor prognosis and are systematically sought during tricuspid regurgitation evaluation. The value of echocardiographic assessment in predicting TTVR outcome is unknown. METHODS: Data were taken from the TriValve (Transcatheter Tricuspid Valve Therapies) registry, which includes patients undergoing TTVR at 14 European and North American centers. The primary outcome was 1-year survival free from hospitalization for heart failure, and secondary outcomes were 1-year survival and absence of hospital admission for heart failure at 1 year. RESULTS: Overall, 249 patients underwent TTVR between June 2015 and 2018 (mean tricuspid annular plane systolic excursion [TAPSE] 15.8 ± 15.3 mm, mean sPAP 43.6 ± 16.0 mm Hg). Tricuspid regurgitation grade ≥3+ was found in 96.8% of patients at baseline and 29.4% at final follow-up; 95.6% were in New York Heart Association functional class III or IV initially, compared with 34.3% at follow-up (p < 0.05). Final New York Heart Association functional class did not differ among TAPSE and sPAP quartiles, even when both low TAPSE and high sPAP were present. Rates of 1-year survival and survival free from hospitalization for heart failure were 83.9% and 78.7%, respectively, without significant differences according to baseline echocardiographic RV characteristics (TAPSE, fractional area change, and end-diastolic area) and sPAP (p > 0.05 for all). CONCLUSIONS: TTVR provides clinical improvement, with 1-year survival free from hospital readmission >75% in patients with severe tricuspid regurgitation. Conventional echocardiographic parameters used to assess RV function and sPAP did not predict clinical outcome after TTVR.

Computing Methods for Composite Clinical Endpoints in Unprotected Left Main Coronary Artery Revascularization: A Post Hoc Analysis of the DELTA Registry.

OBJECTIVES: The study sought to investigate the impact of different computing methods for composite endpoints other than time-to-event (TTE) statistics in a large, multicenter registry of unprotected left main coronary artery (ULMCA) disease. BACKGROUND: TTE statistics for composite outcome measures used in ULMCA studies consider only the first event, and all the contributory outcomes are handled as if of equal importance. METHODS: The TTE, Andersen-Gill, win ratio (WR), competing risk, and weighted composite endpoint (WCE) computing methods were applied to ULMCA patients revascularized by percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) at 14 international centers. RESULTS: At a median follow-up of 1,295 days (interquartile range: 928 to 1,713 days), all analyses showed no difference in combinations of death, myocardial infarction, and cerebrovascular accident between PCI and CABG. When target vessel revascularization was incorporated in the composite endpoint, the TTE (p = 0.03), Andersen-Gill (p = 0.04), WR (p = 0.025), and competing risk (p < 0.001) computing methods showed CABG to be significantly superior to PCI in the analysis of 1,204 propensity-matched patients, whereas incorporating the clinical relevance of the component endpoints using WCE resulted in marked attenuation of the treatment effect of CABG, with loss of significance for the difference between revascularization strategies (p = 0.10). CONCLUSIONS: In a large study of ULMCA revascularization, incorporating the clinical relevance of the individual outcomes resulted in sensibly different findings as compared with the conventional TTE approach. In particular, using the WCE computing method, PCI and CABG were no longer significantly different with respect to the composite of death, myocardial infarction, cerebrovascular accident, or target vessel revascularization at a median of 3 years.

Radiation Exposure and Contrast Agent Reduction During Transcatheter Aortic Valve Implantation: An Ongoing Experience.

OBJECTIVES: To determine the patient radiation exposure and contrast agent variation during transcatheter aortic valve implantation (TAVI) procedures resulting from technological improvements. METHODS: TAVI procedures from January 2008 to July 2015 were analyzed in three different time periods: 1st period, when the angiography was equipped with an image intensifier technology; 2nd period, starting with the installation of a new angiography system with flat-panel detector (FPD) technology; and 3rd period, starting with the systematic use of preprocedural multidetector computed tomography (MDCT) to individualize optimal fluoroscopic projections for the aortic prosthesis implantation. RESULTS: Significant differences were found in contrast volume (198 ± 99 mL vs 139 ± 74 mL; P<.001), kerma area product (211 ± 135 Gy•cm² vs 147 ± 120 Gy•cm²; P<.001) and effective dose (42 ± 27 mSv vs 29 ± 24 mSv; P<.001) between the 1st and 2nd periods, respectively. The reduction continued between the 2nd and 3rd periods for contrast volume (139 ± 74 mL vs 110 ± 61 mL; P<.001), kerma area product (147 ± 120 Gy•cm² vs 111 ± 69 Gy•cm²; P<.001), and effective dose (29 ± 24 mSv vs 22 ± 11 mSv; P<.001), respectively. CONCLUSIONS: The present study suggests that the appropriate use of FPD technology and preprocedural MDCT to individualize fluoroscopic implant projections for TAVI temporally reduced the amount of radiation and contrast agent administered over time.

Transcatheter Replacement of Failed Bioprosthetic Valves: Large Multicenter Assessment of the Effect of Implantation Depth on Hemodynamics After Aortic Valve-in-Valve.

BACKGROUND: Transcatheter valve implantation inside failed bioprosthetic surgical valves (valve-in-valve [ViV]) may offer an advantage over reoperation. Supra-annular transcatheter valve position may be advantageous in achieving better hemodynamics after ViV. Our objective was to define targets for implantation that would improve hemodynamics after ViV. METHODS AND RESULTS: Cases from the Valve-in-Valve International Data (VIVID) registry were analyzed using centralized core laboratory assessment blinded to clinical events. Multivariate analysis was performed to identify independent predictors of elevated postprocedural gradients (mean ≥20 mm Hg). Optimal implantation depths were defined by receiver operating characteristic curve. A total of 292 consecutive patients (age, 78.9±8.7 years; 60.3% male; 157 CoreValve Evolut and 135 Sapien XT) were evaluated. High implantation was associated with significantly lower rates of elevated gradients in comparison with low implantation (CoreValve Evolut, 15% versus 34.2%; P=0.03 and Sapien XT, 18.5% versus 43.5%; P=0.03, respectively). Optimal implantation depths were defined: CoreValve Evolut, 0 to 5 mm; Sapien XT, 0 to 2 mm (0-10% frame height); sensitivities, 91.3% and 88.5%, respectively. The strongest independent correlate for elevated gradients after ViV was device position (high: odds ratio, 0.22; confidence interval, 0.1-0.52; P=0.001), in addition to type of device used (CoreValve Evolut: odds ratio, 0.5; confidence interval, 0.28-0.88; P=0.02) and surgical valve mechanism of failure (stenosis/mixed baseline failure: odds ratio, 3.12; confidence interval, 1.51-6.45; P=0.002). CONCLUSIONS: High implantation inside failed bioprosthetic valves is a strong independent correlate of lower postprocedural gradients in both self- and balloon-expandable transcatheter valves. These clinical evaluations support specific implantation targets to optimize hemodynamics after ViV.

Is it time to simplify the TAVI procedure? "Make it simple but not too simple".

As transcatheter aortic valve implantation (TAVI) becomes a standardised procedure with reproducible and excellent periprocedural, early and medium-term outcomes, it is opportune to question whether the time has come to simplify the TAVI procedure. In some centres, a minimalist approach to TAVI is already the standard of care. In this perspective, we share our experience and opinions on how and when we can simplify the TAVI procedure.

The role of intravascular ultrasound and quantitative angiography in the functional assessment of intermediate coronary lesions: correlation with fractional flow reserve.

BACKGROUND: The correlation between fractional flow reserve (FFR) and intravascular ultrasound (IVUS) metrics including minimal lumen area (MLA), plaque burden and morphology remain a matter of debate. METHODS: Between June 2008 and May 2013, 132 intermediate stenoses in 109 patients were assessed by FFR, IVUS and quantitative angiography. Receiver-operating characteristic (ROC) curve analyses were used to identify MLA/lesion length/plaque burden cut-off values predictive of FFR <0.80. RESULTS: FFR <0.80 was observed in 39 lesions. In the entire cohort, MLA value <2.70mm(2) had 79.5% sensitivity, 76.3% specificity, 0.822 area under curve (AUC), 58.5% positive predictive value, 89.9% negative predictive value and 77.3% accuracy in predicting a positive FFR. In lesions with reference diameter vessel (RVD) ≥3.0mm, the MLA cut-off value was 2.84mm(2) (sensitivity 72.2%, specificity 83.0%, AUC 0.842) whereas in lesions with RVD <3.0mm, 2.59mm(2) (sensitivity 90.5%, specificity 69.6%, AUC 0.823). A moderate correlation was observed between MLA and FFR (r=0.429, p<0.001). The cut-off lesion length predictive of FFR <0.80 was 11.0mm with a weak correlation between the two (r=-0.348, p<0.001). Plaque morphology did not significantly affect FFR (p=0.485). On multivariable analysis, MLA (OR: 0.15; 95% CI: 0.05-0.40; p<0.001) and plaque burden (OR: 1.11; 95% CI: 1.04-1.20; p<0.003) were independent predictors of FFR <0.80. CONCLUSION: A modest, yet significant correlation was observed between MLA and FFR. The high negative predictive value of large MLAs (using afore-mentioned cut-off values) may provide some degree of confidence that the lesion in question is not functionally significant.

Assessment of efficacy and safety of combining "paclitaxel" eluting balloon and "limus" eluting stent in the same lesion.

OBJECTIVES: To assess the safety and efficacy of combining drug-eluting balloon (DEB) and drug-eluting stents (DES) in the same coronary lesion. BACKGROUND: Use of DEB may not always produce optimal results or even result in dissection, compelling the operators to consider bailout stenting with bare metal stents (BMS). However, BMS may not be ideal in patients who have significant risk-profile for restenosis. We have opted for DES over BMS in such situations and present our follow-up data. METHODS: Between 2009 and 2011, 46 patients (57 lesions) requiring bailout stenting following DEB use were treated with second-generation DES. All patients had at-least one or more risk-factors that made them vulnerable for restenosis (diabetes, chronic kidney disease, previous in-stent restenosis [ISR], and/or long diffuse lesions ≥ 30 mm). RESULTS: Of the 57 lesions, 34 (60%) were previous ISR. The mean length of the DEB was: 36.2 ± 5.6 mm. All patients had TIMI-3 flow post PCI with no in-lab complications. At median follow-up of 12.3 months (interquartile range [IQR]: 7.5-18.1), the rates target lesion revascularization (TLR) and target vessel revascularization (TVR) were 3 (5.3%) and 4 (7%), respectively. One patient had died 3 months following treatment. There were no episodes of myocardial infarction, definite or probable stent thrombosis. The major adverse cardiovascular events (MACE) rate defined as cardiac-death, MI, and TVR occurred in 11% of patients. CONCLUSION: The results from this novel strategy of combining "Paclitaxel" eluting balloon and "Limus" eluting stent in a same lesion are encouraging. Dual drug-elution acting on two different pathways may provide potential synergy that may explain the favorable outcome.

Incidence, management, and outcomes of cardiac tamponade during transcatheter aortic valve implantation: a single-center study.

OBJECTIVES: The aim of this study was to explore the incidence, causes, and outcomes of cardiac tamponade in patients undergoing transcatheter aortic valve implantation (TAVI). BACKGROUND: Use of TAVI is increasing, but the procedure is vulnerable to complications, given the cohort of patients. Cardiac tamponade is a possible complication, and there is a scarcity of data on the incidence and outcomes of cardiac tamponade during TAVI. METHODS: All patients who sustained cardiac tamponade during or post-TAVI between 2007 and 2012 were included in the study. RESULTS: Of 389 patients who underwent TAVI, 17 (4.3%) had cardiac tamponade. The mean age was 82.3 ± 3.7 years, and most were women (n = 12, 70.6%). Causes of cardiac tamponade were right ventricular perforation by temporary pacemaker (9 patients, 52.9%), annular rupture or aortic dissection (4 patients, 23.5%), and tear in the left ventricular free wall caused by Amplatz stiff wire or catheters (4 patients, 23.5%). Mortality occurred in 4 patients (23.5%), and all had tamponade caused by injury to the high-pressured left-sided circulation (left ventricle and aorta). Most patients (n = 14, 82.4%) sustained cardiac tamponade during the procedure-2 patients (11.7%) within 24 h, and 1 patient after 24 h. CONCLUSIONS: Cardiac tamponade during TAVI is not frequent but is associated with high mortality rates especially when left-sided structures are involved. Meticulous handling of the equipment and improvements in the safety of currently used devices could further reduce the occurrence of this complication.

Incidence, predictors, management, immediate and long-term outcomes following grade III coronary perforation.

OBJECTIVES: The aim of this study was to evaluate the incidence, predictors, management, and clinical outcomes in patients with grade III coronary perforation during percutaneous coronary intervention. BACKGROUND: Grade III coronary perforation is a rare but recognized complication associated with high morbidity and mortality. METHODS: From 24,465 patients undergoing percutaneous coronary intervention from May 1993 to December 2009, 56 patients had grade III coronary perforation. RESULTS: Most lesions were complex: 44.6% type B2, 51.8% type C, and 28.6% chronic total occlusions, and within a small vessel (≤ 2.5 mm) in 32.1%. Glycoprotein IIb/IIIa inhibitors were administered in 17.9% of patients. The device causing perforation was intracoronary balloon in 50%: 53.6% compliant, 46.4% noncompliant; intracoronary guidewire in 17.9%; rotablation in 3.6%; and directional atherectomy in 3.6%. Following perforation, immediate treatment and success rates, respectively, were prolonged balloon inflation 58.9%, 54.5%; covered stent implantation 46.4%, 84.6%; coronary artery bypass graft surgery (CABG) and surgical repair 16.0%, 44.4%; and coil embolization 1.8%, 100%. Multiple methods were required in 39.3%. During the procedure (n = 56), 19.6% required cardiopulmonary resuscitation and 3.6% died. In-hospital (n = 54), 3.7% required CABG, 14.8% died. The combined procedural and in-hospital myocardial infarction rate was 42.9%, and major adverse cardiac event rate was 55.4%. At clinical follow-up (n = 46) (median: 38.1 months, range 7.6 to 122.8), 4.3% had a myocardial infarction, 4.3% required CABG, and 15.2% died. The target lesion revascularization rate was 13%, with target vessel revascularization in 19.6%, and major adverse cardiac events in 41.3%. CONCLUSIONS: Grade III coronary perforation is associated with complex lesions and high acute and long-term major adverse cardiac event rates.