Publications by authors named "Michael J Mack"

562 Publications

Mortality after multivessel revascularisation involving the proximal left anterior descending artery.

Heart 2022 Jun 22. Epub 2022 Jun 22.

Department of Cardiology, National University of Ireland Galway, Galway, Ireland

Objective: We sought to investigate whether long-term clinical outcomes differ following percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) in patients with three-vessel disease (3VD) and lesions in the proximal left anterior descending artery (P-LAD).

Methods: This post-hoc analysis of the Synergy between PCI with Taxus and Cardiac Surgery (SYNTAX) Extended Survival study included patients with 3VD who were classified according to the presence or absence of lesions located in the P-LAD. Ten-year all-cause death and 5-year major adverse cardiac or cerebrovascular events (MACCE) were assessed.

Results: Among 1088 patients with 3VD, 559 (51.4%) had involvement of P-LAD and their 10-year mortality was numerically higher following PCI versus CABG (28.9% vs 21.9%; HR: 1.39, 95% CI 0.99 to 1.95). Although patients without P-LAD lesions had significantly higher 10-year mortality following PCI compared with CABG, there was no evidence of a treatment-by-subgroup interaction (28.8% vs 20.2%; HR: 1.47, 95% CI 1.03 to 2.09, p=0.837). The incidence of MACCE at 5 years was significantly higher with PCI than CABG, irrespective of involvement of P-LAD (with P-LAD: HR: 1.86, 95% CI 1.36 to 2.55; without P-LAD: HR: 1.54, 95% CI 1.11 to 2.12; p=0.408). Individualised assessment using the SYNTAX Score II 2020 established that a quarter of patients with P-LAD lesions had significantly higher mortality with PCI than CABG, whereas in the remaining three-quarters CABG had similar mortality.

Conclusions: Among patients with 3VD, the presence or absence of a P-LAD lesion was not associated with any treatment effect on long-term outcomes following PCI or CABG.

Trial Registration Number: SYNTAXES: NCT03417050; SYNTAX: NCT00114972.
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http://dx.doi.org/10.1136/heartjnl-2022-320934DOI Listing
June 2022

External Support for Saphenous Vein Grafts in Coronary Artery Bypass Surgery: A Randomized Clinical Trial.

JAMA Cardiol 2022 Jun 8. Epub 2022 Jun 8.

Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, New York.

Importance: Intimal hyperplasia and subsequent saphenous vein graft failure may have significant adverse clinical effects in patients undergoing coronary artery bypass surgery. External support of saphenous vein grafts has the potential to prevent vein graft dilation and hence slow the rate of intimal hyperplasia and increase long-term vein patency.

Objective: To determine efficacy, as measured by intimal hyperplasia, and safety of an external saphenous vein graft support device in patients undergoing a coronary bypass graft procedure.

Design, Setting, And Participants: This within-patient randomized, open-label, multicenter study was conducted at 17 Cardiothoracic Surgical Trials Network centers in North America. Between January 2018 and February 2019, 224 patients with multivessel coronary artery disease undergoing isolated bypass surgery were enrolled. For each patient, 1 of 2 vein grafts was randomized to receive external support or no support.

Interventions: External vein graft support or no support.

Main Outcomes And Measures: The primary efficacy end point was intimal hyperplasia area assessed by intravascular ultrasound at 12 months postrandomization for each study graft. Secondary confirmatory end points were lumen diameter uniformity assessed by angiography and graft failure (≥50% stenosis) by quantitative coronary angiography. Major cardiac and cerebrovascular events were collected through month 12.

Results: Among 224 patients (mean [SD] age, 65.8 [8.3] years; 178 [79.5%] male), 203 (90.6%) were eligible for intravascular ultrasound, of which 85 (41.9%) had at least 1 study graft occluded or severely diseased at 12 months (55 supported, 56 unsupported). After imputation of data missing because of graft occlusion or severe disease, the estimated mean (SE) intimal hyperplasia area was 5.11 (0.16) mm2 in supported grafts and 5.79 (0.20) mm2 in unsupported grafts (P = .07). In a sensitivity analysis of 113 patients with both grafts imaged, the mean intimal hyperplasia area was 4.58 (0.18) mm2 and 5.12 (0.23) mm2 in supported and unsupported grafts, respectively (P = .04). By 12 months, 5 patients (2.2%) died and 16 patients (7.1%) experienced a major cardiac or cerebrovascular event.

Conclusions And Relevance: The 12-month difference in intimal hyperplasia area between supported and unsupported grafts did not achieve statistical significance. Cumulative mortality and major cardiac or cerebrovascular events rates were similar to those in other randomized coronary artery bypass trials. Further investigation to assess the effect of external graft support devices on long-term graft patency and clinical outcomes is warranted.

Trial Registration: ClinicalTrials.gov Identifier: NCT03209609.
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http://dx.doi.org/10.1001/jamacardio.2022.1437DOI Listing
June 2022

Antithrombotic Drug Removal from Whole Blood Using Haemoadsorption with a Porous Polymer Bead Sorbent.

Eur Heart J Cardiovasc Pharmacother 2022 Jun 3. Epub 2022 Jun 3.

CytoSorbents Medical Inc. Princeton, NJ, USA.

Aim: To evaluate the ability of the DrugSorb™-AntiThrombotic Removal (ATR) haemoadsorption device utilizing porous polymer bead sorbent technology to remove 3 commonly used antithrombotic drugs from whole blood.

Methods: We evaluated the removal of apixaban, rivaroxaban, and ticagrelor by the DrugSorb-ATR haemoadsorption device in a benchtop clinical scale model using bovine whole blood. Blood spiked at clinically relevant concentrations of an antithrombotic agent was continuously circulated through a 300-mL DrugSorb-ATR haemoadsorption device at a flow rate of 300 mL/min. Drug concentration was monitored over 6 hours to evaluate drug removal. Results were compared to a control circuit without the haemoadsorption device.

Results: Removal rates at 30, 60, 120 and 360 minutes were: apixaban: 81.5%, 96.3%, 99.3% >99.8%; rivaroxaban: 80.7%, 95.1%, 98.9%, >99.5%; ticagrelor: 62.5%; 75%, 86.6%, >95% (all p<0.0001 vs. control). Blood pH and hematological parameters were not significantly affected by the DrugSorb-ATR haemoadsorption device when compared with the control circuit.

Conclusion: DrugSorb-ATR efficiently removes apixaban, rivaroxaban, and ticagrelor in a clinical-scale benchtop recirculation circuit with the bulk of removal occurring in the first 60 minutes. The clinical implications of these findings are currently investigated in patients undergoing on-pump cardiothoracic surgery in two U.S pivotal trials (ClinicalTrials.gov Identifiers: NCT04976530 and NCT05093504).
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http://dx.doi.org/10.1093/ehjcvp/pvac036DOI Listing
June 2022

Neutrophil-to-Lymphocyte Ratios in Patients Undergoing Aortic Valve Replacement: The PARTNER Trials and Registries.

J Am Heart Assoc 2022 Jun 3;11(11):e024091. Epub 2022 Jun 3.

Division of Cardiology NewYork-Presbyterian Hospital/Columbia University Medical Center New York NY.

Background The neutrophil-to-lymphocyte ratio (NLR) as a marker of systemic inflammation has been associated with worse prognosis in several chronic disease states, including heart failure. However, few data exist on the prognostic impact of elevated baseline NLR or change in NLR levels during follow-up in patients undergoing transcatheter or surgical aortic valve replacement (TAVR or SAVR) for aortic stenosis. Methods and Results NLR was available in 5881 patients with severe aortic stenosis receiving TAVR or SAVR in PARTNER (Placement of Aortic Transcatheter Valves) I, II, and S3 trials/registries (median [Q1, Q3] NLR, 3.30 [2.40, 4.90]); mean NLR, 4.10; range, 0.5-24.9) and was evaluated as continuous variable and categorical tertiles (low: NLR ≤2.70, n=1963; intermediate: NLR 2.70-4.20, n=1958; high: NLR ≥4.20, n=1960). No patients had known baseline infection. High baseline NLR was associated with increased risk of death or rehospitalization at 3 years (58.4% versus 41.0%; adjusted hazard ratio [aHR], 1.39; 95% CI, 1.18-1.63; <0.0001) compared with those with low NLR, irrespective of treatment modality. In both patients treated with TAVR and patients treated with SAVR, NLR decreased between baseline and 2 years. A 1-unit observed decrease in NLR between baseline and 1 year was associated with lower risk of death or rehospitalization between 1 year and 3 years (aHR, 0.86; 95% CI, 0.82-0.89; <0.0001). Conclusions Elevated baseline NLR was independently associated with increased subsequent mortality and rehospitalization after TAVR or SAVR. The observed decrease in NLR after TAVR or SAVR was associated with improved outcomes. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT00530894, NCT0134313, NCT02184442, NCT03225001, NCT0322141.
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http://dx.doi.org/10.1161/JAHA.121.024091DOI Listing
June 2022

Outcomes of aortic root enlargement during isolated aortic valve replacement.

J Card Surg 2022 May 22. Epub 2022 May 22.

Baylor Scott and White Research Institute, Dallas, Texas, USA.

Objectives: Aortic root enlargement (ARE) lowers the risk of patient prosthesis mismatch after surgical aortic valve replacement (SAVR) in patients with small annular size. Whether ARE is associated with increased operative mortality is controversial. This study compares the early and intermediate outcomes in patients undergoing SAVR with and without ARE.

Methods: All patients undergoing isolated SAVR with and without ARE from 2015 to 2020 were analyzed. Propensity-matching was used to adjust for possible confounding variables. Kaplan-Meier analysis and log-rank test were used to estimate and compare overall outcomes and survival in the study cohorts.

Results: Among 868 isolated SAVRs, ARE was performed in 54 (6.2%) patients. Before matching, mean age was similar but female sex (67.4% vs. 29.6%; SD: -0.82) and previous AVR (18.9% vs. 3.9%; SD: -0.48) were more common in patients undergoing SAVR + ARE versus SAVR alone. A bovine pericardial patch was used for 81.5% (44 of 54) of ARE, with a Dacron patch in the rest. After propensity matching, the average cardiopulmonary bypass (138.2 ± 34.9 vs. 102.9 ± 33.0 min; p < 0.01) and cross-clamp times (113.8 ± 26.7 vs. 83.0 ± 28.4 min; p < 0.01) were longer in the SAVR + ARE group. There were no significant differences in postoperative stroke, new-onset dialysis, pacemaker placement, reoperation for bleeding, length of hospital stay, or 30-day readmission. Thirty-day mortality (0% vs. 0.6%, p = 1.0) and 5-year survival (96.3% vs. 95.7%, p = 0.86) were also similar.

Conclusions: ARE during surgical AVR can be safely performed without an increase in complications with excellent early and intermediate-term survival.
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http://dx.doi.org/10.1111/jocs.16645DOI Listing
May 2022

Predicted and Observed Mortality at 10 Years in Patients With Bifurcation Lesions in the SYNTAX Trial.

JACC Cardiovasc Interv 2022 Jun 17;15(12):1231-1242. Epub 2022 May 17.

Department of Cardiology, National University of Ireland, Galway, Galway, Ireland.

Background: Percutaneous coronary intervention (PCI) of bifurcation lesions is associated with higher rates of adverse events, and currently it is unclear whether PCI or coronary artery bypass grafting (CABG) is the safer treatment for these patients at very long-term follow-up.

Objectives: The aim of this study was to investigate the impact of bifurcation lesions on individual predicted and observed all-cause 10-year mortality in the SYNTAX (Synergy Between PCI With Taxus and Cardiac Surgery) trial.

Methods: In the SYNTAXES (SYNTAX Extended Survival) study, 10-year observed and individual predicted mortality derived from the SYNTAX score 2020 (SS-2020) was compared between patients with ≥1 bifurcation (n = 1,300) and those with no bifurcations (n = 487).

Results: Among patients treated with PCI, patients with >1 bifurcation lesion compared with those without bifurcation lesions had a significantly higher risk for all-cause death (19.8% vs 30.1%; HR: 1.55; 95% CI: 1.12-2.14; P = 0.007), whereas following CABG, mortality was similar in patients with and those without bifurcation lesions (23.3% vs 23.0%; HR: 0.81; 95% CI: 0.59-1.12; P = 0.207; P = 0.006). In PCI patients, a 2-stent vs a 1-stent technique was associated with higher mortality (33.3% vs 25.9%; HR: 1.51; 95% CI: 1.06-2.14; P = 0.021). According to the SS-2020, among those with ≥1 bifurcation, there was equipoise for all-cause mortality between PCI and CABG in 2 quartiles of the population, whereas CABG was superior to PCI in the 2 remaining quartiles.

Conclusions: Bifurcation lesions require special attention from the heart team, considering the higher 10-year all-cause mortality associated with PCI. Careful evaluation of bifurcation lesion complexity and calculation of individualized 10-year prognosis using the SS-2020 may therefore be helpful in decision making. (Synergy Between PCI With TAXUS and Cardiac Surgery: SYNTAX Extended Survival [SYNTAXES], NCT03417050; Taxus Drug-Eluting Stent Versus Coronary Artery Bypass Surgery for the Treatment of Narrowed Arteries [SYNTAX], NCT00114972).
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http://dx.doi.org/10.1016/j.jcin.2022.04.025DOI Listing
June 2022

Evolution and Prognostic Impact of Cardiac Damage After Aortic Valve Replacement.

J Am Coll Cardiol 2022 May 14. Epub 2022 May 14.

Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; St. Francis Hospital and Heart Center, Roslyn, New York.

Background: The impact of aortic valve replacement (AVR) on progression/regression of extra-valvular cardiac damage and its association with subsequent prognosis is unknown.

Objectives: To describe evolution of cardiac damage post-AVR and its association with outcomes.

Methods: Patients undergoing transcatheter or surgical AVR from the PARTNER 2 and 3 trials were pooled and classified by cardiac damage stage at baseline and 1-year (Stage 0, no damage; Stage 1, left ventricular damage; Stage 2, left atrial or mitral valve damage; Stage 3, pulmonary vasculature or tricuspid valve damage; Stage 4, right ventricular damage). Proportional hazards models determined association between change in cardiac damage post-AVR and 2-year outcomes.

Results: Among 1974 patients, 121 (6.1%) were Stage 0, 287 (14.5%) Stage 1, 1014 (51.4%) Stage 2, 412 (20.9%) Stage 3, and 140 (7.1%) Stage 4 pre-AVR. Two-year mortality was associated with extent of cardiac damage at baseline and 1-year. Compared with baseline, cardiac damage improved in ∼15%, remained unchanged in ∼60%, and worsened in ∼25% of patients at 1-year. One-year change in cardiac damage stage was independently associated with mortality (adjHR for improvement=0.49; no change=1.0; worsening=1.95; p=0.023) and composite of death or heart failure hospitalization (adjHR for improvement=0.60; no change=1.0; worsening=2.25; p<0.001) at 2 years.

Conclusion: In patients undergoing AVR, extent of extravalvular cardiac damage at baseline and its change at 1-year have important prognostic implications. These findings suggest that earlier detection of AS and intervention prior to development of irreversible cardiac damage may improve global cardiac function and prognosis.
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http://dx.doi.org/10.1016/j.jacc.2022.05.006DOI Listing
May 2022

Regulatory strategies for early device development and approval.

Catheter Cardiovasc Interv 2022 May 29;99(6):1784-1788. Epub 2022 Apr 29.

Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA.

The development of new technology to treat unmet clinical needs is an important component of modern cardiovascular disease. The need for this has been emphasized in the past several years beginning with the Food and Drug Administration (FDA) guidance document on Early Feasibility Studies in 2012 and then the 21st Century Cures legislation. A number of steps need to be considered in this process by the stakeholders involved including physician innovators and scientists, professional societies such as Society for Cardiovascular Angiography & Interventions, regulatory agencies, and medical device companies. This article focuses on the early iterative steps required to optimize the process and achieve the goal of timely efficient innovation and device development in cardiovascular disease.
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http://dx.doi.org/10.1002/ccd.30151DOI Listing
May 2022

The impact of perioperative stroke and delirium on outcomes after surgical aortic valve replacement.

J Thorac Cardiovasc Surg 2022 Mar 18. Epub 2022 Mar 18.

Department of Psychiatry & Behavioral Sciences, Duke University Medical Center, Durham, NC.

Objective: The effects of stroke and delirium on postdischarge cognition and patient-centered health outcomes after surgical aortic valve replacement (SAVR) are not well characterized. Here, we assess the impact of postoperative stroke and delirium on these health outcomes in SAVR patients at 90 days.

Methods: Patients (N = 383) undergoing SAVR (41% received concomitant coronary artery bypass graft) enrolled in a randomized trial of embolic protection devices underwent serial neurologic and delirium evaluations at postoperative days 1, 3, and 7 and magnetic resonance imaging at day 7. Outcomes included 90-day functional status, neurocognitive decline from presurgical baseline, and quality of life.

Results: By postoperative day 7, 25 (6.6%) patients experienced clinical stroke and 103 (28.5%) manifested delirium. During index hospitalization, time to discharge was longer in patients experiencing stroke (hazard ratio, 0.62; 95% confidence interval [CI], 0.42-0.94; P = .02) and patients experiencing delirium (hazard ratio, 0.68; 95% CI, 0.54-0.86; P = .001). At day 90, patients experiencing stroke were more likely to have a modified Rankin score >2 (odds ratio [OR], 5.9; 95% CI, 1.7-20.1; P = .01), depression (OR, 5.3; 95% CI, 1.6-17.3; P = .006), a lower 12-Item Short Form Survey physical health score (adjusted mean difference -3.3 ± 1.9; P = .08), and neurocognitive decline (OR, 7.8; 95% CI, 2.3-26.4; P = .001). Delirium was associated with depression (OR, 2.2; 95% CI, 0.9-5.3; P = .08), lower 12-Item Short Form Survey physical health (adjusted mean difference -2.3 ± 1.1; P = .03), and neurocognitive decline (OR, 2.2; 95% CI, 1.2-4.0; P = .01).

Conclusions: Stroke and delirium occur more frequently after SAVR than is commonly recognized, and these events are associated with disability, depression, cognitive decline, and poorer quality of life at 90 days postoperatively. These findings support the need for new interventions to reduce these events and improve patient-centered outcomes.
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http://dx.doi.org/10.1016/j.jtcvs.2022.01.053DOI Listing
March 2022

Improving the National Cardiovascular Data Registry's Value to Elevate the Quality of Cardiovascular Care.

J Am Coll Cardiol 2022 05;79(17):1713-1716

Duke University, Durham, North Carolina, USA.

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http://dx.doi.org/10.1016/j.jacc.2022.02.039DOI Listing
May 2022

Anxiety and Depression Following Aortic Valve Replacement.

J Am Heart Assoc 2022 May 26;11(9):e024377. Epub 2022 Apr 26.

Division of Cardiology Department of Medicine Duke University Health System Durham NC.

Background The aim of this study was to identify patients vulnerable for anxiety and/or depression following aortic valve replacement (AVR) and to evaluate factors that may mitigate this risk. Methods and Results This is a retrospective cohort study conducted using a claims database; 18 990 patients (1/2013-12/2018) ≥55 years of age with 6 months of pre-AVR data were identified. Anxiety and/or depression risk was compared at 3 months, 6 months, and 1 year following transcatheter aortic valve replacement or surgical AVR (SAVR) after risk adjustment using logistic regression and Cox proportional hazards models. Separate models were estimated for patients with and without surgical complications and discharge location. Patients with SAVR experienced a higher relative risk of anxiety and/or depression at 3 months (12.4% versus 8.8%; adjusted hazard ratio [HR] 1.39 [95% CI, 1.19-1.63]) and 6 months (15.6% versus 13.0%; adjusted HR, 1.24 [95% CI, 1.08-1.42]), with this difference narrowing by 12 months (20.1% versus 19.3%; adjusted HR, 1.14 [95% CI, 1.01-1.29]) after AVR. This association was most pronounced among patients discharged to home, with patients with SAVR having a higher relative risk of anxiety and/or depression. In patients who experienced operative complications, there was no difference between SAVR and transcatheter aortic valve replacement. However, among patients without operative complications, patients with SAVR had an increased risk of postoperative anxiety and/or depression at 3 months (adjusted HR, 1.47 [95% CI, 1.23-1.75]) and 6 months (adjusted HR 1.26 [95% CI, 1.08-1.46]), but not at 12 months. Conclusions There is an associated reduction in the risk of new-onset anxiety and/or depression among patients undergoing transcatheter aortic valve replacement (versus SAVR), particularly in the first 3 and 6 months following treatment.
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http://dx.doi.org/10.1161/JAHA.121.024377DOI Listing
May 2022

The Management of Transcatheter Heart Valve Dysfunction: Another Tool in the Box.

J Am Coll Cardiol 2022 04;79(14):1352-1355

Departments of Cardiology and Cardiac Surgery, Baylor Scott and White Health, Heart Hospital Plano, Plano, Texas, USA.

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http://dx.doi.org/10.1016/j.jacc.2022.02.029DOI Listing
April 2022

ECMO: We Need to Vent About the Need to Vent!

J Am Coll Cardiol 2022 04;79(13):1251-1253

Department of Cardiac Surgery, Baylor Scott and White Health, Dallas, Texas, USA.

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http://dx.doi.org/10.1016/j.jacc.2022.01.034DOI Listing
April 2022

Characteristics and clinical outcomes in patients with prior chest radiation undergoing TAVR: Observations from PARTNER-2.

Catheter Cardiovasc Interv 2022 May 15;99(6):1877-1885. Epub 2022 Mar 15.

Division of Cardiology, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA.

Objectives: The purpose of this study is to investigate the viability of transcatheter aortic valve replacement (TAVR) for severe symptomatic aortic stenosis (AS) in patients with prior chest radiation therapy (cXRT).

Background: Since patients with prior cXRT perform poorly with surgical aortic valve replacement, TAVR can be a viable alternative. However, clinical outcomes after TAVR in this patient population have not been well studied.

Methods: From the pooled registry of the placement of aortic transcatheter valves II trial, we identified patients with and without prior cXRT who underwent TAVR (n = 64 and 3923, respectively). The primary outcome was a composite of all-cause death and any stroke at 2 years. Time to event analyses were shown as Kaplan-Meier event rates and compared by log-rank testing. Hazard ratios (HRs) were estimated and compared by Cox proportional hazards regression model.

Results: There was no significant difference in the primary outcome between the patients with and without prior cXRT (30.7% vs. 27.0%; p = 0.75; HR, 1.08; 95% confidence interval, 0.66-1.77). Rates of myocardial infarction, vascular complications, acute kidney injury, or new pacemaker implant after TAVR were not statistically different between the two groups. The rate of immediate reintervention with a second valve for aortic regurgitation after TAVR was higher among the patients with prior cXRT. However, no further difference was observed during 2 years follow-up after discharge from the index-procedure hospitalization.

Conclusions: TAVR is a viable alternative for severe symptomatic AS in patients who had cXRT in the past.
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http://dx.doi.org/10.1002/ccd.30154DOI Listing
May 2022

The PARTNER 3 Bicuspid Registry for Transcatheter Aortic Valve Replacement in Low-Surgical-Risk Patients.

JACC Cardiovasc Interv 2022 03;15(5):523-532

St. Paul's Hospital, University of British Columbia, Vancouver, British Columbia, Canada.

Objectives: The study compared 1-year outcomes between transcatheter aortic valve replacement (TAVR) patients with bicuspid aortic valve (BAV) morphology and clinically similar patients having tricuspid aortic valve (TAV) morphology.

Background: There are limited prospective data on TAVR using the SAPIEN 3 device in low-surgical-risk patients with severe, symptomatic aortic stenosis and bicuspid anatomy.

Methods: Low-risk, severe aortic stenosis patients with BAV were candidates for the PARTNER 3 (Placement of Aortic Transcatheter Valves 3) (P3) bicuspid registry or the P3 bicuspid continued access protocol. Patients treated in these registries were pooled and propensity score matched to TAV patients from the P3 randomized TAVR trial. Outcomes were compared between groups. The primary endpoint was the 1-year composite rate of death, stroke, and cardiovascular rehospitalization.

Results: Of 320 total submitted BAV patients, 169 (53%) were treated, and most were Sievers type 1. The remaining 151 patients were excluded caused by anatomic or clinical criteria. Propensity score matching with the P3 TAVR cohort (496 patients) yielded 148 pairs. There were no differences in baseline clinical characteristics; however, BAV patients had larger annuli and they experienced longer procedure duration. There was no difference in the primary endpoint between BAV and TAV (10.9% vs 10.2%; P = 0.80) or in the rates of the individual components (death: 0.7% vs 1.4%; P = 0.58; stroke: 2.1% vs 2.0%; P = 0.99; cardiovascular rehospitalization: 9.6% vs 9.5%; P = 0.96).

Conclusions: Among highly select bicuspid aortic stenosis low-surgical-risk patients without extensive raphe or subannular calcification, TAVR with the SAPIEN 3 valve demonstrated similar outcomes to a matched cohort of patients with tricuspid aortic stenosis.
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http://dx.doi.org/10.1016/j.jcin.2022.01.279DOI Listing
March 2022

Transcatheter Tricuspid Valve Replacement With the EVOQUE System: 1-Year Outcomes of a Multicenter, First-in-Human Experience.

JACC Cardiovasc Interv 2022 03;15(5):481-491

St. Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.

Objectives: The aim of this study was to report the midterm outcomes at 1 year in the expanded first-in-human experience with the transfemoral EVOQUE system (Edwards Lifesciences) for tricuspid regurgitation (TR).

Background: Untreated TR is associated with excess mortality and morbidity. The first-in-human experience with the EVOQUE tricuspid valve replacement system reported favorable 30-day outcomes with no mortality in a compassionate use population.

Methods: Twenty-seven patients with severe TR were treated with the EVOQUE system in a compassionate use experience at 7 centers between May 2019 and July 2020. All patients had clinical right-sided heart failure (HF) and were deemed inoperable and unsuitable for transcatheter edge-to-edge repair by the institutional heart teams. The clinical outcomes collected included all-cause mortality, symptom status, TR severity, HF hospitalization, and major adverse cardiovascular events.

Results: At baseline, all patients (age: 77 ± 8 years, 89% female) were at high surgical risk (mean Society of Thoracic Surgeons score: 8.6% ± 5.5%), with 89% New York Heart Association functional class III/IV. TR was predominantly functional in etiology (19/27, 70%). At 1 year, mortality was 7% (2/27), 70% of patients were New York Heart Association functional class I/II, and 96% and 87% of patients had a TR grade ≤2+ and ≤1+, respectively. Between 30 days and 1 year, 2 patients experienced HF hospitalizations, and 1 patient required a new pacemaker implantation.

Conclusions: In this early, compassionate use experience, the transfemoral transcatheter EVOQUE tricuspid valve replacement system demonstrated durable efficacy, persistent improvement in symptom status, and low rates of mortality and HF hospitalizations at a 1-year follow-up. Further studies are underway to validate its efficacy.
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http://dx.doi.org/10.1016/j.jcin.2022.01.280DOI Listing
March 2022

Transfemoral Tricuspid Valve Replacement in Patients With Tricuspid Regurgitation: TRISCEND Study 30-Day Results.

JACC Cardiovasc Interv 2022 03;15(5):471-480

Cedars-Sinai Medical Center, Los Angeles, California, USA.

Objectives: The TRISCEND study (Edwards EVOQUE Tricuspid Valve Replacement: Investigation of Safety and Clinical Efficacy after Replacement of Tricuspid Valve with Transcatheter Device) is evaluating the safety and performance of transfemoral transcatheter tricuspid valve replacement in patients with clinically significant tricuspid regurgitation (TR) and elevated surgical risk.

Background: Transcatheter valve replacement could lead to a paradigm shift in treating TR and improving patient quality of life.

Methods: In the prospective, single-arm, multicenter TRISCEND study, patients with symptomatic moderate or greater TR, despite medical therapy, underwent percutaneous transcatheter tricuspid valve replacement with the EVOQUE system. A composite rate of major adverse events, echocardiographic parameters, and clinical, functional, and quality-of-life measures were assessed at 30 days.

Results: Fifty-six patients (mean age of 79.3 years, 76.8% female, 91.1% TR severe or greater, 91.1% atrial fibrillation, and 87.5% New York Heart Association functional class III or IV) were treated. At 30 days, TR was reduced to mild or less in 98%. The composite major adverse events rate was 26.8% at 30 days caused by 1 cardiovascular death in a patient with a failed procedure, 2 reinterventions after device embolization, 1 major access site or vascular complication, and 15 severe bleeds, of which none were life-threatening or fatal. No myocardial infarction, stroke, renal failure, major cardiac structural complications, or device-related pulmonary embolism were observed. New York Heart Association significantly improved to functional class I or II (78.8%; P < 0.001), 6-minute walk distance improved 49.8 m (P < 0.001), and Kansas City Cardiomyopathy Questionnaire score improved 19 points (P < 0.001).

Conclusions: Early experience with the transfemoral EVOQUE system in patients with clinically significant TR demonstrated technical feasibility, acceptable safety, TR reduction, and symptomatic improvement at 30 days. The TRISCEND II randomized trial (NCT04482062) is underway.
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http://dx.doi.org/10.1016/j.jcin.2022.01.016DOI Listing
March 2022

Practice Patterns and Outcomes of Transcatheter Aortic Valve Replacement in the United States and Japan: A Report From Joint Data Harmonization Initiative of STS/ACC TVT and J-TVT.

J Am Heart Assoc 2022 03 4;11(6):e023848. Epub 2022 Mar 4.

Department of Cardiovascular Surgery Osaka University Hospital Osaka Japan.

Background The practice pattern and outcome of medical devices following their regulatory approval may differ by country. The aim of this study is to compare postapproval national clinical registry data on transcatheter aortic valve replacement between the United States and Japan on patient characteristics, periprocedural outcomes, and the variability of outcomes as a part of a partnership program (Harmonization-by-Doing) between the 2 countries. Methods and Results The patient-level data were extracted from the US Society of Thoracic Surgeons /American College of Cardiology Transcatheter Valve Therapy (STS/ACC TVT) and the J-TVT (Japanese Transcatheter Valvular Therapy) registry, respectively, to analyze transcatheter aortic valve replacement outcomes between 2013 and 2019. Data entry for these registries was mandated by the federal regulators, and the majority of variable definitions were harmonized to allow direct data comparison. A total of 244 722 transcatheter aortic valve replacements from 646 institutions in the United States and 26 673 transcatheter aortic valve replacements from 171 institutions in Japan were analyzed. Median volume per site was 65 (interquartile range, 45-97) in the United States and 28 (interquartile range, 19-41) in Japan. Overall, patients in J-TVT were older (United States: mean-age, 80.1±8.7 versus Japan: 84.4±5.2; <0.001), were more frequently women (45.9% versus 68.1%; <0.001), and had higher median Society of Thoracic Surgeons Predicted Risk of Mortality (5.27% versus 6.20%; <0.001) than patients in the United States. Japan had lower unadjusted 30-day mortality (1.3% versus 3.2%; <0.001) and composite outcomes of death, stroke, and bleeding (17.5 versus 22.5%; <0.001) but had higher conversion to open surgery (0.94% versus 0.56%; <0.001). Conclusions This collaborative analysis between the United States and Japan demonstrated the feasibility of international comparison using the national registries coded under mutual variable definitions. Both countries obtained excellent outcomes, although the Japanese had lower 30-day mortality and major morbidity. Harmonization-by-Doing is one of the key steps needed to build global-level learning to improve patient outcomes.
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http://dx.doi.org/10.1161/JAHA.121.023848DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9075277PMC
March 2022

Structural valve degeneration of bioprosthetic aortic valves: A network meta-analysis.

J Thorac Cardiovasc Surg 2022 Jan 14. Epub 2022 Jan 14.

Department of Cardiothoracic Surgery, Baylor Scott & White The Heart Hospital, Plano, Tex.

Objective: To compare the rate of structural valve degeneration (SVD) following surgical aortic valve replacement associated with the Trifecta (TF) valve (St Jude Medical) versus other bioprosthetic valves.

Methods: A systematic literature search was conducted for studies comparing durability of the TF prosthesis to other valve types, including Perimount (Edwards Lifesciences), Carpentier-Edwards Perimount Magna Ease (ME) (Edwards Lifesciences), and Mitroflow (LivaNova USA) after surgical aortic valve replacement. Random effect pairwise and network meta-analyses were performed to compare the incident rate ratio of the composite primary outcome of SVD or reintervention due to SVD.

Results: Ten studies with 31,029 patients were included, of whom 6832 received TF, 19,023 received Perimount, 3514 received ME, and 713 received Mitroflow. When compared with TF, ME was associated with lower rates of SVD or reintervention for SVD (incident rate ratio, 0.13; 95% CI, 0.02-0.92; P = .04). Similarly, at network meta-analysis, when compared with TF, only ME was associated with significantly lower rates of SVD or reintervention for SVD (incident rate ratio, 0.13; 95% CI, 0.02-0.97). ME (incident rate ratio, 0.18; 95% CI, 0.07-0.47) and PM (incident rate ratio, 0.34; 95% CI, 0.12-0.98) were associated with significantly lower rate of all-cause reintervention when compared with TF. No differences in the other secondary outcomes were found.

Conclusions: The TF valve is associated with significantly higher rates of SVD or reintervention for SVD than the ME valve, but not the Mitroflow valve. The TF valve was also associated with higher rates of all-cause reintervention than ME and Perimount valves. The underlying mechanism(s) of these findings warrant further investigation.
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http://dx.doi.org/10.1016/j.jtcvs.2021.12.047DOI Listing
January 2022

Impact of baseline renal dysfunction on cardiac outcomes and end-stage renal disease in heart failure patients with mitral regurgitation: the COAPT trial.

Eur Heart J 2022 05;43(17):1639-1648

Clinical Trials Center, Cardiovascular Research Foundation, New York, NY, USA.

Aims: Baseline renal dysfunction (RD) adversely impacts outcomes among patients with heart failure (HF) and severe secondary mitral regurgitation (MR). Heart failure and MR, in turn, accelerate progression to end-stage renal disease (ESRD), worsening prognosis. We sought to determine the impact of RD in HF patients with severe MR and the impact of transcatheter mitral valve repair (TMVr) on new-onset ESRD and the need for renal replacement therapy (RRT).

Methods And Results: The COAPT trial randomized 614 patients with HF and severe MR to MitraClip plus guideline-directed medical therapy (GDMT) vs. GDMT alone. Patients were stratified into three RD subgroups based on baseline estimated glomerular filtration rate (eGFR, mL/min/1.73 m2): none (≥60), moderate (30-60), and severe (<30). End-stage renal disease was defined as eGFR <15 mL/min/1.73 m2 or RRT. The 2-year rates of all-cause death or HF hospitalization (HFH), new-onset ESRD, and RRT according to RD and treatment were assessed. Baseline RD was present in 77.0% of patients, including 23.8% severe RD, 6.0% ESRD, and 5.2% RRT. Worse RD was associated with greater 2-year risk of death or HFH (none 45.3%; moderate 53.9%; severe 69.2%; P < 0.0001). MitraClip vs. GDMT alone improved outcomes regardless of RD (Pinteraction = 0.62) and reduced new-onset ESRD [2.9 vs. 8.1%, hazard ratio (HR) 0.34, 95% confidence interval (CI) 0.15-0.76, P = 0.008] and the need for new RRT (2.5 vs. 7.4%, HR 0.33, 95% CI 0.14-0.78, P = 0.011).

Conclusion: Baseline RD was common in the HF patients with severe MR enrolled in COAPT and strongly predicted 2-year death and HFH. MitraClip treatment reduced new-onset ESRD and the need for RRT, contributing to the improved prognosis after TMVr.
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http://dx.doi.org/10.1093/eurheartj/ehac026DOI Listing
May 2022

Age-Related Outcomes After Transcatheter Mitral Valve Repair in Patients With Heart Failure: Analysis From COAPT.

JACC Cardiovasc Interv 2022 02 31;15(4):397-407. Epub 2022 Jan 31.

The Zena and Michael A. Wiener Cardiovascular Institute, Mount Sinai Hospital, Icahn School of Medicine at Mount Sinai, New York, New York, USA; Clinical Trials Center, Cardiovascular Research Foundation, New York, New York, USA. Electronic address:

Objectives: The aim of this study was to assess the impact of age on outcomes in patients undergoing transcatheter edge-to-edge repair (TEER) from the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) trial.

Background: In the COAPT trial, TEER with the MitraClip device in patients with heart failure (HF) and moderate to severe or severe secondary mitral regurgitation (SMR) reduced the risk for HF hospitalization (HFH) and all-cause mortality compared with maximally tolerated guideline-directed medical therapy (GDMT) alone. There are limited data regarding the effectiveness of MitraClip therapy in elderly patients.

Methods: Patients (n = 614) were grouped by median age at randomization (74 years) and by MitraClip treatment vs GDMT alone. The primary endpoint was the 2-year rate of death or HFH assessed by multivariable Cox regression.

Results: Death or HFH within 2 years occurred less frequently after treatment with the MitraClip vs GDMT alone in patients <74 years of age (37.3% vs 64.5%; adjusted HR: 0.41; 95% CI: 0.29-0.59) and ≥74 years of age (51.7% vs 69.6%; adjusted HR: 0.58; 95% CI: 0.42-0.81) (P = 0.17). Mortality was also consistently reduced with MitraClip treatment in young and elderly patients (P = 0.42). In contrast, elderly patients treated with the MitraClip vs GDMT alone tended to have a lesser reduction of HFH than younger patients (P = 0.03). Younger and older patients had similar improvements in quality of life after treatment with the MitraClip compared with GDMT alone.

Conclusions: In the COAPT trial, MitraClip treatment of moderate to severe and severe SMR reduced the composite risk for death or HFH and improved survival and quality of life regardless of age. As such, young and elderly patients with HF and severe SMR benefit from TEER, although elderly patients may not have as great a benefit from the MitraClip device in reducing HFH.
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http://dx.doi.org/10.1016/j.jcin.2021.11.037DOI Listing
February 2022

Long-Term Impact of Preventive Tricuspid Valve Annuloplasty on Right Ventricular Remodeling.

Am J Cardiol 2022 04 23;169:93-99. Epub 2022 Jan 23.

Department of Cardiology, Leiden University Medical Center, Leiden, The Netherlands; Heart Center, University of Turku and Turku University Hospital, Turku, Finland. Electronic address:

In patients with primary mitral regurgitation (MR), concomitant tricuspid valve (TV) annuloplasty at the time of left-sided valve surgery is indicated in case of a dilated TV annulus ≥40 mm independent of the presence or severity of tricuspid regurgitation (TR). However, the long-term impact on right ventricular (RV) adverse remodeling is less well established and the benefit of preventive TV annuloplasty remains controversial. The aim of the study was to assess differences in long-term RV adverse remodeling and the development of significant TR in those patients. In total, 98 patients (mean age 65 ± 11 years, 85% men) with significant primary MR and TV annulus dilatation ≥40 mm without significant TR who underwent mitral valve (MV) repair with or without concomitant TV annuloplasty were included. Of the 98 patients, 28 patients underwent isolated MV repair without TV annuloplasty and 70 patients received concomitant TV annuloplasty at the time of MV surgery. The RV basal diameter (p = 0.03), RV long-axis diameter (p = 0.04), RV end-diastolic area (p <0.01), and RV end-systolic area (p = 0.03) showed less adverse remodeling at follow-up in patients with concomitant TV annuloplasty compared with patients without TV annuloplasty. Additionally, 4 patients (14%) in the subgroup without TV annuloplasty developed significant TR during follow-up in contrast to zero patients in the subgroup with TV annuloplasty (p = 0.001). In conclusion, concomitant preventive TV annuloplasty during MV surgery in patients with primary MR, no significant TR and a tricuspid annulus (≥40 mm) prevented RV adverse remodeling and the development of significant TR at long-term follow-up.
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http://dx.doi.org/10.1016/j.amjcard.2021.12.048DOI Listing
April 2022

Cost-effectiveness of transcatheter edge-to-edge repair in secondary mitral regurgitation.

Heart 2022 05 25;108(9):717-724. Epub 2022 Jan 25.

University of Glasgow Robertson Centre for Biostatistics, Glasgow, UK.

Background: Transcatheter edge-to-edge mitral valve repair (TMVr) improves symptoms and survival for patients with heart failure with reduced left ventricular ejection fraction (HFrEF) and severe secondary mitral regurgitation despite guideline-recommended medical therapy (GRMT). Whether TMVr is cost-effective from a UK National Health Service (NHS) perspective is unknown.

Methods: We used patient-level data from the Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation (COAPT) trial to perform a cost-effectiveness analysis of TMVr +GRMT versus GRMT alone from an NHS perspective. Costs for the TMVr procedure were based on standard English tariffs and device costs. Subsequent costs were estimated based on data acquired during the trial. Health utilities were estimated using the Short-Form 6-Dimension Health Survey.

Results: Costs for the index procedural hospitalisation were £18 781, of which £16 218 were for the TMVr device. Over 2-year follow-up, TMVr reduced subsequent costs compared with GRMT (£10 944 vs £14 932, p=0.006), driven mainly by reductions in heart failure hospitalisations; nonetheless, total 2-year costs remained higher with TMVr (£29 165 vs £14 932, p<0.001). When survival, health utilities and costs were projected over a lifetime, TMVr was projected to increase life expectancy by 1.57 years and quality-adjusted life expectancy by 1.12 quality-adjusted life-years (QALYs) at an incremental cost of £21 980, resulting in an incremental cost-effectiveness ratio (ICER) of £23 270 per QALY gained (after discounting). If the benefits of TMVr observed in the first 2 years were maintained without attenuation, the ICER improved to £12 494 per QALY.

Conclusions: For patients with HFrEF and severe secondary mitral regurgitation similar to those enrolled in COAPT, TMVr increases life expectancy and quality-adjusted life expectancy compared with GRMT at an ICER that represents good value from an NHS perspective.
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http://dx.doi.org/10.1136/heartjnl-2021-320005DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8995818PMC
May 2022

Time-of-Day and Clinical Outcomes After Surgical or Transcatheter Aortic Valve Replacement: Insights From the PARTNER Trials.

Circ Cardiovasc Qual Outcomes 2022 01 18;15(1):e007948. Epub 2022 Jan 18.

Institut universitaire de cardiologie et de pneumologie de Québec, Université Laval/Québec Heart and Lung Institute, Laval University, Canada (F.V., J.T., P.P.).

Background: Circadian rhythms may influence myocardial tolerance to ischemia-reperfusion phenomena occurring during cardiac procedures. While conflicting results exist on the effect of time-of-day on surgical aortic valve replacement (SAVR), afternoon procedures could be associated with a reduced risk of death, rehospitalization or periprocedural myocardial infarction, compared with morning procedures. We examined the impact of procedure time-of-day on outcomes after transcatheter aortic valve replacement (TAVR) or SAVR.

Methods: We analyzed patients at intermediate- or high-surgical risk who underwent elective TAVR (n=4457) or SAVR (n=1129) in the PARTNER (Placement of Aortic Transcatheter Valve) 1 and 2 trials and registries according to time-of-day (morning versus afternoon) using the Kaplan-Meier event rates and multivariable Cox proportional hazards regression models. Sensitivity analysis was conducted using 1:1 propensity-score matching. The primary end point was all-cause death or rehospitalization at 2 years.

Results: At 2 years, no difference was observed between patients operated in the morning versus the afternoon within the SAVR (32.3% versus 30.6%, adjusted hazard ratio, 1.08 [95% CI, 0.82-1.41], =0.58) and TAVR cohorts (35.7% versus 35.4%, adjusted hazard ratio, 1.01 [95% CI, 0.89-1.14], =0.86) with regards to the primary end point. Rates of periprocedural myocardial infarction were low and similar between morning and afternoon in SAVR (1.6% versus 1.0%, =0.51) and TAVR (0.4% versus 0.4%, =0.86), as were all other clinical end points. Similar results were observed in propensity-score matched analysis.

Conclusions: Procedure time-of-day was not associated with clinical outcomes after TAVR or SAVR. Registration: URL: https://www.clinicaltrials.gov; Unique identifiers: NCT00530894, NCT01314313, NCT03222141, and NCT03222128.
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http://dx.doi.org/10.1161/CIRCOUTCOMES.121.007948DOI Listing
January 2022

Impact of Frailty and Prefrailty on Outcomes of Transcatheter or Surgical Aortic Valve Replacement.

Circ Cardiovasc Interv 2022 01 18;15(1):e011375. Epub 2022 Jan 18.

Cardiovascular Research Foundation, NY (M.B.L., M.A., D.J.C.).

Background: Randomized trials have shown short- and mid-term benefits with transcatheter versus surgical aortic valve replacement (TAVR versus SAVR) for patients at intermediate or low-risk for surgery. Frailty and prefrailty could explain some of this benefit due to an impaired ability to recover fully from a major surgical procedure.

Methods: We examined 2-year outcomes (survival and Kansas City Cardiomyopathy Questionnaire [KCCQ] scores) among patients at intermediate or low surgical risk treated with transfemoral-TAVR or SAVR within the PARTNER (Placement of Aortic Transcatheter Valves) 2A trial, SAPIEN 3 intermediate-risk registry, and PARTNER 3 trial. Frailty was examined as a continuous variable based on grip strength, gait speed, serum albumin, and activities of daily living. We tested the interaction of frailty markers by treatment (TAVR versus SAVR) in proportional hazards regression models (survival) and piecewise linear regression models (KCCQ), adjusting for patient demographic and clinical factors.

Results: Among the 3025 patients in the analytic cohort (2003 TAVR, 1022 SAVR; mean age 79.3 years, 61.6% men), 799 (26.4%) were nonfrail, 2041 (67.5%) were prefrail (1-2 frailty markers), and 185 (6.1%) were frail (3-4 frailty markers). Increasing frailty (none versus prefrail versus frail) was associated with higher 2-year mortality (5.5% versus 11.1% versus 22.8%; log-rank <0.001) and worse 2-year health status among survivors (KCCQ scores adjusted for baseline: 84.8 versus 79.6 versus 77.4, <0.001). In multivariable models, there were no significant interactions between frailty markers and treatment group for either survival (interaction =0.39) or health status (interaction >0.47 for all time points).

Conclusions: In a cohort of older patients with severe aortic stenosis who were at low or intermediate surgical risk, increasing frailty markers were associated with worse 2-year mortality and greater health status impairment after either TAVR or SAVR, but there were no significant interactions between type of valve replacement and frailty with respect to either outcome.
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http://dx.doi.org/10.1161/CIRCINTERVENTIONS.121.011375DOI Listing
January 2022

The Heart Valve Collaboratory: A Disruptive Model in the Management of Valvular Heart Disease.

J Am Coll Cardiol 2022 01;79(2):192-196

U.S. Food and Drug Administration, Silver Spring, Maryland, USA.

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http://dx.doi.org/10.1016/j.jacc.2021.10.040DOI Listing
January 2022

10-Year All-Cause Mortality Following Percutaneous or Surgical Revascularization in Patients With Heavy Calcification.

JACC Cardiovasc Interv 2022 01 29;15(2):193-204. Epub 2021 Dec 29.

Department of Cardiology, National University of Ireland, Galway, Galway, Ireland.

Objectives: The aim of this study was to assess 10-year all-cause mortality in patients with heavily calcified lesions (HCLs) undergoing percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG).

Background: Limited data are available on very long term outcomes in patients with HCLs according to the mode of revascularization.

Methods: This substudy of the SYNTAXES (Synergy Between PCI With Taxus and Cardiac Surgery Extended Survival) study assessed 10-year all-cause mortality according to the presence of HCLs within lesions with >50% diameter stenosis and identified during the calculation of the anatomical SYNTAX (Synergy Between PCI With Taxus and Cardiac Surgery) score among 1,800 patients with the 3-vessel disease and/or left main disease randomized to PCI or CABG in the SYNTAX trial. Patients with HCLs were further stratified according to disease type (3-vessel disease or left main disease) and assigned treatment (PCI or CABG).

Results: The 532 patients with ≥1 HCL had a higher crude mortality rate at 10 years than those without (36.4% vs 22.3%; HR: 1.79; 95% CI: 1.49-2.16; P < 0.001). After adjustment, an HCL remained an independent predictor of 10-year mortality (HR: 1.36; 95% CI: 1.09-1.69; P = 0.006). There was a significant interaction in mortality between treatment effect (PCI and CABG) and the presence or absence of HCLs (P = 0.005). In patients without HCLs, mortality was significantly higher after PCI than after CABG (26.0% vs 18.8%; HR: 1.44; 95% CI: 0.97-1.41; P = 0.003), whereas in those with HCLs, there was no significant difference (34.0% vs 39.0%; HR: 0.85; 95% CI: 0.64-1.13; P = 0.264).

Conclusions: At 10 years, the presence of an HCL was an independent predictor of mortality, with a similar prognosis following PCI or CABG. Whether HCLs require special consideration when deciding the mode of revascularization beyond their current contribution to the anatomical SYNTAX score deserves further evaluation. (Synergy Between PCI With TAXUS and Cardiac Surgery: SYNTAX Extended Survival [SYNTAXES], NCT03417050; SYNTAX Study: TAXUS Drug-Eluting Stent Versus Coronary Artery Bypass Surgery for the Treatment of Narrowed Arteries [SYNTAX], NCT00114972).
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http://dx.doi.org/10.1016/j.jcin.2021.10.026DOI Listing
January 2022

Minimally Invasive Versus Full Sternotomy for Isolated Aortic Valve Replacement in Low-Risk Patients.

Ann Thorac Surg 2021 Dec 24. Epub 2021 Dec 24.

Department of Cardiothoracic Surgery, Baylor Scott & White Healthcare, Plano, Texas.

Background: Surgical aortic valve replacement can be performed through a minimally invasive (MI) or full sternotomy (FS) approach. The present study compared outcomes of MI vs FS for isolated surgery among patients enrolled in the Placement of Aortic Transcatheter Valves (PARTNER) 3 low-risk trial.

Methods: Patients with severe, symptomatic aortic stenosis at low surgical risk with anatomy suitable for transfemoral access were eligible for PARTNER 3 enrollment. The primary outcome was the composite end point of death, stroke, or rehospitalization (valve-, procedure-, or heart failure-related) at 1 year. Secondary outcomes included the individual components of the primary end point as well as patient-reported health status at 30 days and 1 year.

Results: In the PARTNER 3 study, 358 patients underwent isolated valve replacement at 68 centers through an MI (n = 107) or FS (n = 251) approach (8 patients were converted from MI to FS). Mean age and Society of Thoracic Surgeons score were similar between groups. The Kaplan-Meier estimate of the primary outcome was similar in the MI vs FS groups (16.9% vs 14.9%; hazard ratio, 1.15; 95% CI, 0.66-2.03; P = .618). There were no significant differences in the 1-year rates of all-cause death (2.8% vs 2.8%), all stroke (1.9% vs 3.6%), or rehospitalization (13.3% vs 10.6%, P > .05 for all). Quality of life, as assessed by the Kansas City Cardiomyopathy Questionnaire score at 30 days or 1 year, was comparable in both groups.

Conclusions: For patients at low risk for isolated surgery, MI and FS approaches were associated with similar in-hospital and 1-year outcomes.
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http://dx.doi.org/10.1016/j.athoracsur.2021.11.048DOI Listing
December 2021
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