Transcatheter Valve Repair in Heart Failure with Moderate to Severe Mitral Regurgitation.

BACKGROUND: Whether transcatheter mitral-valve repair improves outcomes in patients with heart failure and functional mitral regurgitation is uncertain. METHODS: We conducted a randomized, controlled trial involving patients with heart failure and moderate to severe functional mitral regurgitation from 30 sites in nine countries. The patients were assigned in a 1:1 ratio to either transcatheter mitral-valve repair and guideline-recommended medical therapy (device group) or medical therapy alone (control group). The three primary end points were the rate of the composite of first or recurrent hospitalization for heart failure or cardiovascular death during 24 months; the rate of first or recurrent hospitalization for heart failure during 24 months; and the change from baseline to 12 months in the score on the Kansas City Cardiomyopathy Questionnaire-Overall Summary (KCCQ-OS; scores range from 0 to 100, with higher scores indicating better health status). RESULTS: A total of 505 patients underwent randomization: 250 were assigned to the device group and 255 to the control group. At 24 months, the rate of first or recurrent hospitalization for heart failure or cardiovascular death was 37.0 events per 100 patient-years in the device group and 58.9 events per 100 patient-years in the control group (rate ratio, 0.64; 95% confidence interval [CI], 0.48 to 0.85; P = 0.002). The rate of first or recurrent hospitalization for heart failure was 26.9 events per 100 patient-years in the device group and 46.6 events per 100 patient-years in the control group (rate ratio, 0.59; 95% CI, 0.42 to 0.82; P = 0.002). The KCCQ-OS score increased by a mean (±SD) of 21.6±26.9 points in the device group and 8.0±24.5 points in the control group (mean difference, 10.9 points; 95% CI, 6.8 to 15.0; P<0.001). Device-specific safety events occurred in 4 patients (1.6%). CONCLUSIONS: Among patients with heart failure with moderate to severe functional mitral regurgitation who received medical therapy, the addition of transcatheter mitral-valve repair led to a lower rate of first or recurrent hospitalization for heart failure or cardiovascular death and a lower rate of first or recurrent hospitalization for heart failure at 24 months and better health status at 12 months than medical therapy alone. (Funded by Abbott Laboratories; RESHAPE-HF2 ClinicalTrials.gov number, NCT02444338.).

Accuracy of the PARIS score and PCI complexity to predict ischemic events in patients treated with very thin stents in unprotected left main or coronary bifurcations.

BACKGROUND: The PARIS risk score (PARIS-rs) and percutaneous coronary intervention complexity (PCI-c) predict clinical and procedural residual ischemic risk following PCI. Their accuracy in patients undergoing unprotected left main (ULM) or bifurcation PCI has not been assessed. METHODS: The predictive performances of the PARIS-rs (categorized as low, intermediate, and high) and PCI-c (according to guideline-endorsed criteria) were evaluated in 3,002 patients undergoing ULM/bifurcation PCI with very thin strut stents. RESULTS: After 16 (12-22) months, increasing PARIS-rs (8.8% vs. 14.1% vs. 27.4%, p < .001) and PCI-c (15.2% vs. 11%, p = .025) were associated with higher rates of major adverse cardiac events ([MACE], a composite of death, myocardial infarction [MI], and target vessel revascularization), driven by MI/death for PARIS-rs and target lesion revascularization/stent thrombosis for PCI-c (area under the curves for MACE: PARIS-rs 0.60 vs. PCI-c 0.52, p-for-difference < .001). PCI-c accuracy for MACE was higher in low-clinical-risk patients; while PARIS-rs was more accurate in low-procedural-risk patients. ≥12-month dual antiplatelet therapy (DAPT) was associated with a lower MACE rate in high PARIS-rs patients, (adjusted-hazard ratio 0.42 [95% CI: 0.22-0.83], p = .012), with no benefit in low to intermediate PARIS-rs patients. No incremental benefit with longer DAPT was observed in complex PCI. CONCLUSIONS: In the setting of ULM/bifurcation PCI, the residual ischemic risk is better predicted by a clinical risk estimator than by PCI complexity, which rather appears to reflect stent/procedure-related events. Careful procedural risk estimation is warranted in patients at low clinical risk, where PCI complexity may substantially contribute to the overall residual ischemic risk.

Cardiovascular magnetic resonance and transesophageal echocardiography in patients with prosthetic valve paravalvular leaks: towards an accurate quantification and stratification.

BACKGROUND: Objective assessment of prosthetic paravalvular leak (PVL) is complex and challenging even in transesophageal echocardiography (TEE). Our aim was to assess the value of cardiovascular magnetic resonance (CMR) in quantifying PVL in aortic (AVR) or mitral valve (MVR) replacement. METHODS: Thirty-one patients (62 ± 15.1 years, 63% males) with a preliminary diagnosis of significant PVL (AVR, n-23; MVR, n = 8) were recruited. The TEE PVL grading was based on the semi-quantitative (SQ) TEE according to the VARC II PVL classification (%PVL: mild < 10%; moderate 10%-30%; severe > 30%). Non-contrast CMR studies were acquired at 1.5 T with a quantitative approach (phase-contrast velocity encoded imaging). The CMR PVL severity was classified according to regurgitant fraction (RF: (1) mild ≤ 20%, (2) moderate 21%-39%, or (3) severe ≥ 40%). RESULTS: All patients revealed symptoms of heart failure (71%: New York Heart Association [NYHA] II; 91%: N-terminal pro-B-type natriuretic peptide [NT-proBNP] > 150 pg/ml) and typical cardiovascular disease risk factors. The SQ-TEE results revealed several categories: (1) mild (n = 5; 16%), (2) moderate (n = 21; 67%), and (3) severe (n = 5; 16%) PVL. However, CMR PVL RF reclassified the severity of PVL: (1) mild to moderate (in 80%), (2) moderate to severe (in 47%), and (3) severe to moderate (in 40%). The receiver operating characteristic analysis showed that SQ-TEE and CMR PVL-vol and -RF predicted the upper tertile of NT-proBNP (> 2000 pg/ml) with the best sensitivity for CMR parameters. CONCLUSION: The SQ-TEE showed moderate agreement with CMR and underestimated a considerable number of AVR or MVR-PVL.

Safety and efficacy of polymer-free biolimus-eluting stents versus ultrathin stents in unprotected left main or coronary bifurcation: A propensity score analysis from the RAIN and CHANCE registries.

OBJECTIVES: Evaluate safety and efficacy of polymer-free biolimus-eluting stents (PF-BESs) versus ultrathin stents in unprotected left main (ULM) or bifurcation. BACKGROUND: PF-BESs due to reduced length of dual antiplatelet therapy (DAPT) are increasingly used. However, there are limited data about safety and efficacy for ULM or bifurcation. METHODS: We selected all-patients treated for ULM or bifurcation from two multicenter real life registries (RAIN [NCT03544294] evaluating ultrathin stents, CHANCE [NCT03622203] appraising PF-BES). After propensity score with matching, the primary endpoint was major adverse cardiac events (MACE; a composite of all-cause death, myocardial infarction, target lesion revascularization [TLR], and stent thrombosis [ST]), while its components along with target vessel revascularization (TVR) secondary endpoints. RESULTS: Three thousand and three patients treated with ultrathin stents and 446 with PF-BESs, resulting respectively in 562 and 281 after propensity score with matching (33 and 22%, respectively, with ULM disease). After 12 (8-20) months, rates of MACE were similar (9 vs. 8%, p = 0.56) without difference in TLR and ST (3.0 vs. 1.7%, p = .19 and 1.8 vs. 1.1%, p = .42). These results were consistent for ULM group (3 vs. 1.7% and 1.8 vs. 1.1%, p = .49 and .76), for non-ULM group (2.1 vs. 3.4%, p = .56 and 1.2 vs. 1.7%, p = .78) and for two-stent strategy (8.7 vs. 4.5% and 4.3 vs. 3.2%, p = .75 and .91). Among patients treated with 1 month of DAPT in both groups, those with ultrathin stents experienced higher rates of MACE related to all-cause death (22 vs. 12%, p = .04) with higher although not significant rates of ST (3 vs. 0%, p = .45). CONCLUSIONS: PF-BES implanted on ULM or BiF offered freedom from TLR and ST comparable to ultrathin stents. PF-BESs patients assuming DAPT for 1 month experienced a lower despite not significant incidence of ST.

Impact of structural features of very thin stents implanted in unprotected left main or coronary bifurcations on clinical outcomes.

OBJECTIVES: To evaluate the independent clinical impact of stent structural features in a large cohort of patients undergoing unprotected left main (ULM) or coronary bifurcation percutaneous coronary intervention (PCI) with a range of very thin strut stents. BACKGROUND: Clinical impact of structural features of contemporary stents remains to be defined. METHODS: All consecutive patients enrolled in the veRy thin stents for patients with left mAIn or bifurcatioN in real life (RAIN) registry were included. The following stent structural features were studied: antiproliferative drugs (everolimus vs. sirolimus vs. zotarolimus), strut material (platinum-chromium vs. cobalt-chromium), polymer (bioresorbable vs. durable), number of crowns (<8 vs. ≥8) and number of connectors (<3 vs. ≥3). For small diameter stents (≤2.5 mm), struct thickness (74 vs. 80/81 µm) was also tested. Target lesion failure (TLF), a composite of target lesion revascularization and stent thrombosis, was the primary endpoint. Multivariate analysis was performed with Cox regression models. RESULTS: Out of 2,707 patients, 110 (4.1%) experienced a TLF event after 16 months (12-18). After adjustment for confounders, an increased number of connectors (adjusted hazard ratio [adj-HR] 0.62, 95% confidence interval (CI) 0.39-0.99, p = .04) reduced risk of TLF, driven by stents with ≥2.5 mm diameter (HR 0.54, 95% CI 0.32-0.93, p = .02). This independent relationship was lost for stents with diameter <2.5 mm, where only strut thickness appeared to impact. Conversely, no independent relationship of polymer type, number of crowns, and the specific limus-family eluted drug with outcomes was observed. CONCLUSIONS: Among a range of contemporary very thin stent models, an increased number of connectors improved device-related outcomes in this investigated high-risk procedural setting.

Comparison of bioresorbable vs durable polymer drug-eluting stents in unprotected left main (from the RAIN-CARDIOGROUP VII Study).

BACKGROUND: There are limited data regarding the impact of bioresorbable polymer drug eluting stent (BP-DES) compared to durable polymer drug eluting stent (DP-DES) in patients treated with percutaneous coronary intervention using ultrathin stents in left main or bifurcations. METHODS: In the RAIN registry (ClinicalTrials NCT03544294, june 2018 retrospectively registered) patients with a ULM or bifurcation stenosis treated with PCI using ultrathin stents (struts thinner than 81 µm) were enrolled. The primary endpoint was the rate of target lesion revascularization (TLR); major adverse cardiovascular events (MACE, a composite of all-cause death, myocardial infarction, TLR and stent thrombosis) and its components, along with target vessel revascularization (TVR) were the secondary ones. A propensity score with matching analysis to compare patients treated with BP-DES versus DP-DES was also assessed. RESULTS: From 3001 enrolled patients, after propensity score analysis 1400 patients (700 for each group) were selected. Among them, 352 had ULM disease and 1048 had non-LM bifurcations. At 16 months (12-22), rates of TLR (3.7% vs 2.9%, p = 0.22) and MACE were similar (12.3% vs. 11.6%, p = 0.74) as well as for the other endpoints. Sensitivity analysis of outcomes after a two-stents strategy, showed better outcome in term of MACE (20.4% vs 10%, p = 0.03) and TVR (12% vs 4.6%, p = 0.05) and a trend towards lower TLR in patients treated with BP-DES. CONCLUSION: In patients with bifurcations or ULM treated with ultrathin stents BP-DES seems to perform similarly to DP-DES: the trends toward improved clinical outcomes in patients treated with the BP-DES might potentially be of value for speculating the stent choice in selected high-risk subgroups of patients at increased risk of ischemic events. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03544294. Retrospectively registered June 1, 2018.

Safety and efficacy of self-apposing Stentys drug-eluting stent in left main coronary artery PCI: Multicentre LM-STENTYS registry.

BACKGROUND: There is a paucity of data on left main (LM) percutaneous coronary intervention (PCI) therapy with dedicated DES platforms. The LM-STENTYS is a multicenter registry aimed at evaluating clinical outcome after PCI of LM performed with a self-apposing Stentys DES implantation. METHODS: The registry consists of 175 consecutive patients treated with Stentys DES implanted to LM. The primary endpoint was the composite of major adverse cardiac and cerebral events (MACCE) defined as cardiac death, myocardial infarction (MI), target lesion revascularization (TLR), and stroke assessed after 1 year. The secondary endpoint was stent thrombosis (ST) at 1 year. RESULTS: The median age was 69 years (IQR, 62-78 years). Acute coronary syndrome (ACS) was the presenting diagnosis in 117 (66.9%) patients [74 (63.2%) unstable angina, 31 (26.5%) NSTEMI, 12 (10.3%) STEMI] and stable angina (SA) was present in 58 (33.1%) patients. The median SYNTAX score was 23.0 (IQR, 18.7-32.2) in the SA group and 25.0 (IQR, 20.0-30.7) in the ACS group. During 1-year follow-up in the SA group two (3.4%) MACCE occurred, both of them were cardiac deaths. In ACS patients there were 19 (16.2%) MACCE [9 (7.7%) cardiac deaths, 11 (9.4%) MIs, 11(9.4%) TLR, 1(0.9%) stroke]. Altogether, three (1.7%) cases of acute ST were noted, all of them in ACS subset. CONCLUSION: LM PCI using self-apposing Stentys DES showed favorable clinical outcomes at 1-year in patients with SA. Events of ST in the ACS group warrant further research.

Self-expandable sirolimus-eluting stents compared to second-generation drug-eluting stents for the treatment of the left main: A propensity score analysis from the SPARTA and the FAILS-2 registries.

OBJECTIVES: To compare the effectiveness and safety of self-expandable, sirolimus-eluting Stentys stents (SES) and second-generation drug-eluting stents (DES-II) for the treatment of the unprotected left main (ULM). BACKGROUND: SES may provide a valuable option to treat distal ULM, particularly when significant caliber gaps with side branches are observed. METHODS: Patients from the multicenter SPARTA (clinicaltrials.gov: NCT02784405) and FAILS2 registries were included. Propensity-score with matching was performed to account for the lack of randomization. Primary end-point was the rate of major adverse cardiovascular events (MACE, a composite of all cause death, myocardial infarction, target lesion revascularization [TLR], unstable angina and definite stent thrombosis [ST]). Single components of MACE were the secondary end-points. RESULTS: Overall, 151 patients treated with SES and 1270 with DES-II were included; no differences in MACE rate at 250 days were observed (9.8% vs. 11.5%, P = 0.54). After propensity score with matching, 129 patients treated with SES and 258 with DES-II, of which about a third of female gender, were compared. After a follow-up of 250 days, MACE rate did not differ between the two groups (9.9% vs. 8.5%, P = 0.66), as well as the rate of ULM TLR (1.6% vs. 3.1%, P = 0.36) and definite ST (0.8% vs. 1.2%, P = 0.78). These results were consistent also when controlling for the treatment with provisional vs. 2-stents strategies for the ULM bifurcation. CONCLUSION: SES use for ULM treatment was associated with a similar MACE rate compared to DES-II at an intermediate-term follow-up. SES might represent a potential option in this setting.

Effects of Transendocardial Delivery of Bone Marrow-Derived CD133+ Cells on Left Ventricle Perfusion and Function in Patients With Refractory Angina: Final Results of Randomized, Double-Blinded, Placebo-Controlled REGENT-VSEL Trial.

RATIONALE: New therapies for refractory angina are needed. OBJECTIVE: Assessment of transendocardial delivery of bone marrow CD133+ cells in patients with refractory angina. METHODS AND RESULTS: Randomized, double-blinded, placebo-controlled trial enrolled 31 patients with recurrent Canadian Cardiovascular Society II-IV angina, despite optimal medical therapy, ≥1 myocardial segment with inducible ischemia in Tc-99m SPECT who underwent bone marrow biopsy and were allocated to cells (n=16) or placebo (n=15). Primary end point was absolute change in myocardial ischemia by SPECT. Secondary end points were left ventricular function and volumes by magnetic resonance imaging and angina severity. After 4 months, there were no significant differences in extent of inducible ischemia between groups (summed difference score mean [±SD]: 2.60 [2.6] versus 3.63 [3.6], P=0.52; total perfusion deficit: 3.60 [3.6] versus 5.01 [4.3], P=0.32; absolute changes of summed difference score: -1.38 [5.2] versus -0.73 [1.9], P=0.65; and total perfusion deficit: -1.33 [3.3] versus -2.19 [6.6], P=0.65). There was a significant reduction of left ventricular volumes (end-systolic volume: -4.3 [11.3] versus 7.4 [11.8], P=0.02; end-diastolic volume: -9.1 [14.9] versus 7.4 [15.8], P=0.02) and no significant change of left ventricular ejection fraction in the cell group. There was no difference in number of patients showing improvement of ≥1 Canadian Cardiovascular Society class after 1 (41.7% versus 58.3%; P=0.68), 4 (50% versus 33.3%; P=0.63), 6 (70% versus 50.0%; P=0.42), and 12 months (55.6% versus 81.8%; P=0.33) and use of nitrates after 12 months. CONCLUSION: Transendocardial CD133+ cell therapy was safe. Study was underpowered to conclusively validate the efficacy, but it did not show a significant reduction of myocardial ischemia and angina versus placebo. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01660581.

Gender differences and bleeding complications after PCI on first and second generation DES.

BACKGROUND: The aim of this study was to evaluate gender differences in the long-term clinical outcomes and safety of patients treated with first- and second generation DES. METHODS: The Katowice-Zabrze Registry included 1916 consecutive patients treated with either first or second generation DES. We evaluated major adverse cardiac and cerebrovascular events (MACCE) [composite of death, myocardial infarction (MI), stroke and target vessel revascularization (TVR)] at 12-month follow-up. Safety end point was bleeding complications and stent thrombosis. RESULTS: Registry included [unstable angina (UA) 1500(78%), non-ST-segment elevation myocardial infarction (NSTEMI) 285 (15%), ST-segment elevation myocardial infarction/left bundle branch block (STEMI/LBBB) 131 (7%)]. There were 35.5% females and 64.5% males. Women were older and had higher prevalence of comorbidities. Males more often had multivessel disease and higher Syntax score when comparable to females. We did not observed difference in acute and subacute stent thrombosis in our data, however, females had more in-hospital bleeding complications. Univariable Cox regression analysis revealed that women had similar outcomes when compared to men in terms of a risk of death, MI, TVR, stroke and MACCE at 1-year follow-up. There were no differences between males and females in MACCE when first- and second generation DES were analyzed separately. CONCLUSION: Despite higher risk profile, women treated with DES have similar outcomes as males in 1-year follow-up. However there is, an increased risk of in-hospital bleedings in women.

Second-generation drug-eluting stents in the elderly patients with acute coronary syndrome: the in-hospital and 12-month follow-up of the all-comer registry.

BACKGROUND: Katowice-Zabrze registry provides data that can be used to evaluate clinical outcomes of percutaneous coronary interventions in elderly patients (≥70 y/o) treated with either first- (DES-I) or second-generation (DES-II) drug-eluting stents (DES). METHODS: The registry consisted of data from 1916 patients treated with coronary interventions using either DES-I or DES-II stents. For our study, we defined patients ≥70 years of age as elderly. We evaluated any major adverse cardiac and cerebral events (MACCE) at 12-month follow-up. RESULTS: Coronary angiography revealed a higher incidence of multivessel coronary artery disease in this elderly patient population. There were no differences in acute and subacute stent thrombosis (0.4 vs. 0.6%, p = 0.760; 0.4 vs. 0.4%; p = 0.712). Elderly patients experienced more in-hospital bleeding complications requiring blood transfusion (2.0 vs. 0.9%; p = 0.003). Resuscitated cardiac arrests (2.0 vs. 0.9%; p = 0.084) were observed more often in this elderly patients during hospitalization. The composite in-hospital MACCE rates did not differ statistically between both groups (1.4 vs. 1.1%; p = 0.567). Data from a twelve-month follow-up disclosed that mortality was higher (7.1 vs. 1.8%; p < 0.001) in the elderly, with no difference in TVR (7.2 vs. 9.9%, p = 0.075), MI (6.0 vs. 4.8%, p = 0.300), stroke (0.8 vs. 0.6%, p = 0.600) and composite MACCE (15.0 vs. 13.4%, p = 0.324). The age of 70 years or over was an independent predictor of death [HR = 2.55 (95% CI 1.49-4.37); p < 0.001]. The use of DES-II reduced the risk of MI [HR = 0.40 (95% CI 0.19-0.82); p = 0.012] in the elderly. CONCLUSION: This elderly patient population had an increased risk of in-hospital bleeding complications requiring blood transfusion and a higher risk of death at 12-month follow-up. The use of new-generation DES reduced the risk of MI in the elderly population.

Multiplug paravalvular leak closure using Amplatzer Vascular Plugs III: A prospective registry.

BACKGROUND: Transcatheter paravalvular leak closure (TPVLC) offers a viable alternative to reoperation but optimal technical strategy is still to be defined. We present a prospective TPVLC registry in which safety and efficacy of multi-plug, single-stage approach were assessed. METHODS: Patients with heart failure (HF) symptoms caused by PVL were qualified for TPVLC by Heart Team. Ante- or retrograde access was employed for mitral while retrograde only for aortic PVLs. Two to 4 AVP 3 devices were simultaneously implanted into each PVL. Endpoints were defined according to VARC-2. RESULTS: From 64 referred patients 49, with either mechanical valves (n = 30) or stented bioprostheses, were eligible for TPVLC. PVL location was mitral (n = 29) or aortic (n = 20). In aortic group acute procedural success (APS) ratio was 100% and no MACCEs occurred. In mitral group, first-attempt TPVLC was successful in 22 cases (4/4 in transapical and 18/25 in transseptal access). Second-attempt transapical procedure followed transseptal failure in 5 patients. Mitral TPVLC ultimately proved efficient in 89.7% with 76.5% APS. Cumulatively, TPVLC was accomplished in 46 subjects (93.9%) with 78% APS. When successful, it led to a significant decrease of NT-proBNP concentration and HF symptoms regression. Periprocedural safety endpoints were met in three patients and included non-disabling stroke, and two access site-related complications. In device failure group two patients died (end-stage HF) and two others were rehospitalized. CONCLUSION: TPVLC with simultaneous deployment of multiple AVP III occluders is feasible with high device success rate and no significant periprocedural complications. The clinical benefits of reduction of HF symptoms and hemolysis are evident after 30 days and persist up to 1 year without recurrence of PVL.

Optical Coherence Tomography of De Novo Lesions and In-Stent Restenosis in Coronary Saphenous Vein Grafts (OCTOPUS Study).

BACKGROUND: The OCTOPUS registry prospectively evaluates the procedural and long-term outcomes of saphenous vein graft (SVG) PCI. The current study assessed the morphology of de novo lesions and in-stent restenosis (ISR) in patients undergoing PCI of SVG. METHODS AND RESULTS: Optical coherence tomography (OCT) of SVG lesions in consecutive patients presenting with stable CAD and ACS was carried out. Thirty-nine patients (32 de novo and 10 ISR lesions) were included in the registry. ISR occurred in 5 BMS and 5 DES. There were no differences in the presence of plaque rupture and thrombus between de novo lesions and ISR. Lipid-rich tissue was identified in both de novo lesions and in ISR (75% vs. 50%, P=0.071) with a higher prevalence in BMS than in DES (23% vs. 7.5%; P=0.048). Calcific de novo lesions were detected in older grafts as compared with non-calcific atheromas (159±57 vs. 90±62 months after CABG, P=0.001). Heterogeneous neointima was found only in ISR (70% vs. 0, P<0.001) and was observed with similar frequency in both BMS and DES (24% vs. 30%, P=0.657). ISR was detected earlier in DES than BMS (median, 50 months; IQR, 18-96 months vs. 27 months; IQR, 13-29 months, P<0.001). CONCLUSIONS: OCT-based characteristics of de novo and ISR lesions in SVG were similar except for heterogeneous tissue, which was observed only in ISR. (Circ J 2016; 80: 1804-1811).

Comparison of First- and Second-Generation Drug-Eluting Stents in an All-Comer Population of Patients with Diabetes Mellitus (from Katowice-Zabrze Registry).

BACKGROUND: This study compared safety and efficacy of first- and second-generation DES in an unrestricted, real-life population of diabetic patients undergoing PCI. MATERIAL AND METHODS: The study was a subanalysis of diabetic patients from the all-comer Katowice-Zabrze Registry of patients undergoing PCI with the implantation of either first- (Paclitaxel-, Sirolimus-eluting stents) or second-generation DES (Zotarolimus-, Everolimus-, Biolimus-eluting stents). Efficacy defined as major adverse cardiac and cerebrovascular events (MACCE: death, myocardial infarction, target vessel revascularization, stroke) and safety defined as stent thrombosis (ST) were evaluated at 1 year. RESULTS: From the total of 1916 patients, 717 were diabetics. Among them, 257 (36%) were treated with first-generation DES (230 [89%] Paclitaxel-eluting stents, 27 [11%] Sirolimus-eluting stents), 460 with second-generation DES (171 [37%] Zotarolimus-eluting stents, 243 [53%] Everolimus-eluting stents, 46 [10%] Biolimus-eluting stents). Rate of MACCE was equal in both groups (p=0.54). Second-generation DES had a better safety profile than first-generation DES (log-rank for cumulative ST at 1 year p<0.001). First-generation DES was a risk factor for ST (HR 5.75 [1.16-28.47], p=0.03) but not for MACCE (HR 0.89 [0.6-1.32], p=0.57). CONCLUSIONS: In a real-life setting of diabetic patients undergoing PCI, second-generation DES had lower risk of ST and similar MACCE rate compared to first-generation DES.

Echocardiography and Cardiac Magnetic Resonance in the Assessment of Left-Ventricle Remodeling: Differences Implying Clinical Decision.

Introduction: Transthoracic echocardiography (TTE) and cardiovascular magnetic resonance (CMR) are the most important modalities used in clinical practice to assess cardiac chambers. However, different imaging techniques may affect their results and conclusions. The aim of our study was to compare left-ventricle (LV) remodeling assessed using TTE and CMR in the context of various cardiovascular diseases. Methods: A total of 202 consecutive patients sent for an elective cardiovascular diagnosis were scheduled for a 2D TTE and CMR, performed within 2 weeks. The study group was divided and analyzed based on the clinical indications for CMR, including coronary artery disease, heart failure, native aortic valve regurgitation or paravalvular leak after aortic valve replacement, or cardiomyopathies. Results: The mean LV mass index (LVMi) values calculated using TTE were significantly larger (127.1 ± 44.5 g/m²) compared to the LVMi assessed using CMR (77.1 ± 26.2 g/m²; p < 0.001). The LV end-diastolic volumes assessed using TTE were underestimated for all the study patients (78.6 ± 43 mL vs. 100.5 ± 39 mL; p < 0.0001) and subgroups, but a statistical trend was observed in patients with cardiomyopathy. Those differences in single parameters led to differences in LV remodeling and the final treatment decision. CMR and TTE provided similar conclusions on LV systolic dysfunction in 68% of the patients. Conclusions: Our results showed that the greater the degree of LV remodeling and dysfunction, the greater the difference between the modalities. Therefore, CMR should be introduced into routine clinical practice, especially for patients undergoing LV remodeling, which may change clinical decisions in a considerable number of cases.

First Case of the Treatment of Massive Tricuspid Regurgitation With the CroíValve DUO Coaptation Valve in a Patient With a Right Ventricular Pacemaker Lead.

Background: Tricuspid regurgitation (TR) is a common valvular disorder with limited treatment options. It occurs when tricuspid leaflet closure is prevented by dilation of the right heart or in patients with cardiac implantable rhythm devices when the transvalvular lead impedes proper closure of the valve. The management of these patients can be complicated. The removal of the lead often does not improve the TR, and surgical repair is usually not possible because of comorbidities. A number of percutaneous TR repair and replacement devices have been developed; however, the presence of the right ventricular lead can prevent the delivery of these devices, or the device may displace the pacemaker lead. We report the first implant of the CroíValve DUO Transcatheter Tricuspid Coaptation Valve System (Dublin, Ireland) in a patient with massive TR and a right ventricular lead. Methods: The patient was not a fit for surgical treatment and underwent transcatheter treatment following compassionate use approval. The procedure was performed under general anesthetic with echo and X-ray guidance. The device was delivered through the right internal jugular vein. Results: The device was implanted successfully, and the TR was reduced from massive to mild at 90-day follow-up. The patient's quality of life improved significantly with an improvement in 6-minute walk test (382 m at baseline to 467 m at follow-up), the New York Heart Association classification (III at baseline to I at follow-up), and the Kansas City Cardiomyopathy Questionnaire (baseline score 43 increased to 60). The efficacy and clinical improvement have been stable over the past 90 days of follow-up, and the patient has not suffered any adverse events. Conclusions: This is the first implantation of the CroíValve DUO Coaptation Valve System in a patient with a pacemaker lead. In these patients, this device may offer advantages over other current transcatheter approaches.

Multicentre short- and medium-term report on the device closure of a post-myocardial infarction ventricular septal rupture - In search of risk factors for early mortality.

BACKGROUND: Post-myocardial infarction ventricular septal rupture (VSR) is a rare and severe complication of myocardial infarction. To find early mortality (<30 days) risk factors of device VSR closure and to evaluate its medium-term outcome. METHODS: Multicenter retrospective analysis on all 46 consecutive patients with percutaneous (n = 43) or hybrid (n = 3) VSR closure in 2000-2020 with various nitinol wire mesh occluders. Medical records, hemodynamic data, procedure results, short- and mid-term follow-up were analyzed (4.8 ± 3.7 years, range: 0.1-15, available in 61.7% of patients). Of the patients, 34.8% underwent VSR closure in acute phase (<21 days after VSR occurrence), 17.4% underwent device closure due to significant residual shunt after previous VSR surgery. RESULTS: Success rate was 78.3%. More than moderate residual shunt, major complications, and early surgical reintervention affected 18.9%, 15.2% (including 2 intra-procedural deaths), and 21.7% of patients, respectively. Early mortality was 26.1% (13.9% in successful vs. 70% in unsuccessful closure; p < 0.001). Older age, need for intra-aortic balloon counterpulsation, severe complications, and procedural failure were identified as risk factors for early mortality. Among patients who survived the early period, the 5-year survival rate was 57.1%. NYHA class improved in 88.2% patients at the latest follow-up. CONCLUSIONS: Procedure of VSR device closure demonstrates an acceptable technical success rate; however, the incidence of severe complications and early mortality is notably high. Older patients in poor hemodynamic condition and those with unsuccessful occluder deployment are particularly at a higher risk of a fatal outcome. The prognosis after early survival is promising.

Percutaneous repair of moderate-to-severe or severe functional mitral regurgitation in patients with symptomatic heart failure: Baseline characteristics of patients in the RESHAPE-HF2 trial and comparison to COAPT and MITRA-FR trials.

AIM: The RESHAPE-HF2 trial is designed to assess the efficacy and safety of the MitraClip device system for the treatment of clinically important functional mitral regurgitation (FMR) in patients with heart failure (HF). This report describes the baseline characteristics of patients enrolled in the RESHAPE-HF2 trial compared to those enrolled in the COAPT and MITRA-FR trials. METHODS AND RESULTS: The RESHAPE-HF2 study is an investigator-initiated, prospective, randomized, multicentre trial including patients with symptomatic HF, a left ventricular ejection fraction (LVEF) between 20% and 50% with moderate-to-severe or severe FMR, for whom isolated mitral valve surgery was not recommended. Patients were randomized 1:1 to a strategy of delivering or withholding MitraClip. Of 506 patients randomized, the mean age of the patients was 70 ± 10 years, and 99 of them (20%) were women. The median EuroSCORE II was 5.3 (2.8-9.0) and median plasma N-terminal pro-B-type natriuretic peptide (NT-proBNP) was 2745 (1407-5385) pg/ml. Most patients were prescribed beta-blockers (96%), diuretics (96%), angiotensin-converting enzyme inhibitors/angiotensin receptor blockers/angiotensin receptor-neprilysin inhibitors (82%) and mineralocorticoid receptor antagonists (82%). The use of sodium-glucose cotransporter 2 inhibitors was rare (7%). Cardiac resynchronization therapy (CRT) devices had been previously implanted in 29% of patients. Mean LVEF, left ventricular end-diastolic volume and effective regurgitant orifice area (EROA) were 31 ± 8%, 211 ± 76 ml and 0.25 ± 0.08 cm2, respectively, whereas 44% of patients had mitral regurgitation severity of grade 4+. Compared to patients enrolled in COAPT and MITRA-FR, those enrolled in RESHAPE-HF2 were less likely to have mitral regurgitation grade 4+ and, on average, HAD lower EROA, and plasma NT-proBNP and higher estimated glomerular filtration rate, but otherwise had similar age, comorbidities, CRT therapy and LVEF. CONCLUSION: Patients enrolled in RESHAPE-HF2 represent a third distinct population where MitraClip was tested in, that is one mainly comprising of patients with moderate-to-severe FMR instead of only severe FMR, as enrolled in the COAPT and MITRA-FR trials. The results of RESHAPE-HF2 will provide crucial insights regarding broader application of the transcatheter edge-to-edge repair procedure in clinical practice.

Hospitalization of Symptomatic Patients With Heart Failure and Moderate to Severe Functional Mitral Regurgitation Treated With MitraClip: Insights From RESHAPE-HF2.

BACKGROUND: For patients with functional mitral regurgitation (FMR) and symptomatic heart failure (HF), randomized trials of mitral transcatheter edge-to-edge repair (M-TEER) have produced conflicting results. OBJECTIVES: This study sought to assess the impact of M-TEER on hospitalization rates, and explore the effects of M-TEER on patients who did or did not have a history of recent HF hospitalizations before undergoing M-TEER. METHODS: RESHAPE-HF2 (Randomized Investigation of the MitraClip Device in Heart Failure: 2nd Trial in Patients with Clinically Significant Functional Mitral Regurgitation) included patients with symptomatic HF and moderate to severe FMR (mean effective regurgitant orifice area 0.25 cm2; 14% >0.40 cm2, 23% <0.20 cm2) and showed that M-TEER reduced recurrent HF hospitalizations with and without the addition of cardiovascular (CV) death and improved quality of life. We now report the results of prespecified analyses on hospitalization rates and for the subgroup of patients (n = 333) with a HF hospitalization in the 12 months before randomization. RESULTS: At 24 months, the time to first event of CV death or HF hospitalization (HR: 0.65; 95% CI: 0.49-0.85; P = 0.002), the rate of recurrent CV hospitalizations (rate ratio [RR]: 0.75; 95% CI: 0.57-0.99; P = 0.046), the composite rate of recurrent CV hospitalizations and all-cause mortality (RR: 0.74; 95% CI: 0.57-0.95; P = 0.017), and of recurrent CV death and CV hospitalizations (RR: 0.76; 95% CI: 0.58-0.99; P = 0.040), were all lower in the M-TEER group. The RR of recurrent hospitalizations for any cause was 0.82 (95% CI: 0.63-1.07; P = 0.15) for patients in the M-TEER group vs control group patients. Patients randomized to M-TEER lost fewer days due to death or HF hospitalization (13.9% [95% CI: 13.0%-14.8%] vs 17.4% [95% CI: 16.4%-18.4%] of follow-up time; P < 0.0001, and 1,067 vs 1,776 total days lost; P < 0.0001). Patients randomized to M-TEER also had better NYHA functional class at 30 days and at 6, 12, and 24 months of follow-up (P < 0.0001). A history of HF hospitalizations before randomization was associated with worse outcomes and greater benefit with M-TEER on the rate of the composite of recurrent HF hospitalizations and CV death (Pinteraction = 0.03) and of recurrent HF hospitalizations within 24 months (Pinteraction = 0.06). CONCLUSIONS: These results indicate that a broader application of M-TEER in addition to optimal guideline-directed medical therapy should be considered among patients with symptomatic HF and moderate to severe FMR, particularly in those with a history of a recent hospitalization for HF.

Two-stage percutaneous closure of paravalvular leak in a patient with stentless aortic bioprosthesis.

We report a case of successful 2-stage percutaneous closure of severe paravalvular leak (PVL) in a patient with stentless aortic bioprosthesis. Threat of pliable prosthesis compression and long course of PVL posed main considerations. Accordingly, Amplatzer vascular plug (AVP) 2 was chosen as occluder. It was delivered transfemorally under fluoroscopy and transesophageal echocardiography guidance. No prosthesis distortion was provoked at the expense of moderate residual leak. Its symptoms after 3 months spurred another AVP 2 implantation, which lead to PVL closure with no effect on valve area. Marked reduction of left ventricle cavity size and NT-proBNP plasma concentration was promptly noted and remains stable in 12-month follow-up.