Reintervention and Survival After Transcatheter Pulmonary Valve Replacement.

BACKGROUND: Transcatheter pulmonary valve (TPV) replacement (TPVR) has become the standard therapy for postoperative pulmonary outflow tract dysfunction in patients with a prosthetic conduit/valve, but there is limited information about risk factors for death or reintervention after this procedure. OBJECTIVES: This study sought to evaluate mid- and long-term outcomes after TPVR in a large multicenter cohort. METHODS: International registry focused on time-related outcomes after TPVR. RESULTS: Investigators submitted data for 2,476 patients who underwent TPVR and were followed up for 8,475 patient-years. A total of 95 patients died after TPVR, most commonly from heart failure (n = 24). The cumulative incidence of death was 8.9% (95% CI: 6.9%-11.5%) 8 years after TPVR. On multivariable analysis, age at TPVR (HR: 1.04 per year; 95% CI: 1.03-1.06 per year; P < 0.001), a prosthetic valve in other positions (HR: 2.1; 95% CI: 1.2-3.7; P = 0.014), and an existing transvenous pacemaker/implantable cardioverter-defibrillator (HR: 2.1; 95% CI: 1.3-3.4; P = 0.004) were associated with death. A total of 258 patients underwent TPV reintervention. At 8 years, the cumulative incidence of any TPV reintervention was 25.1% (95% CI: 21.8%-28.5%) and of surgical TPV reintervention was 14.4% (95% CI: 11.9%-17.2%). Risk factors for surgical reintervention included age (0.95 per year [95% CI: 0.93-0.97 per year]; P < 0.001), prior endocarditis (2.5 [95% CI: 1.4-4.3]; P = 0.001), TPVR into a stented bioprosthetic valve (1.7 [95% CI: 1.2-2.5]; P = 0.007), and postimplant gradient (1.4 per 10 mm Hg [95% CI: 1.2-1.7 per 10 mm Hg]: P < 0.001). CONCLUSIONS: These findings support the conclusion that survival and freedom from reintervention or surgery after TPVR are generally comparable to outcomes of surgical conduit/valve replacement across a wide age range.

Multicenter Study of Endocarditis After Transcatheter Pulmonary Valve Replacement.

BACKGROUND: Endocarditis has emerged as one of the most impactful adverse events after transcatheter pulmonary valve replacement (TPVR), but there is limited information about risk factors for and outcomes of this complication. OBJECTIVES: The purpose of this study was to evaluate risk factors for and outcomes of endocarditis in a large multicenter cohort. METHODS: The authors established an international registry focused on characterizing endocarditis after TPVR, including the incidence, risk factors, characteristics, and outcomes. RESULTS: Investigators submitted data for 2,476 patients who underwent TPVR between July 2005 and March 2020 and were followed for 8,475 patient-years. In total, 182 patients were diagnosed with endocarditis a median of 2.7 years after TPVR, for a cumulative incidence of 9.5% (95% CI: 7.9%-11.1%) at 5 years and 16.9% (95% CI: 14.2%-19.8%) at 8 years (accounting for competing risks: death, heart transplant, and explant) and an annualized incidence of 2.2 per 100 patient-years. Staphylococcus aureus and Viridans group Streptococcus species together accounted for 56% of cases. Multivariable analysis confirmed that younger age, a previous history of endocarditis, and a higher residual gradient were risk factors for endocarditis, but transcatheter pulmonary valve type was not. Overall, right ventricular outflow tract (RVOT) reintervention was less often to treat endocarditis than for other reasons, but valve explant was more often caused by endocarditis. Endocarditis was severe in 44% of patients, and 12 patients (6.6%) died, nearly all of whom were infected with Staphylococcus aureus. CONCLUSIONS: The incidence of endocarditis in this multicenter registry was constant over time and consistent with prior smaller studies. The findings of this study, along with ongoing efforts to understand and mitigate risk, will be critical to improve the lifetime management of patients with heart disease involving the RVOT. Although endocarditis can be a serious adverse outcome, TPVR remains an important tool in the management of RVOT dysfunction.

Transcatheter aortic valve implantation with the self-expanding Portico valve system in an all-comers population: procedural and clinical outcomes.

AIMS: Transcatheter aortic valve implantation (TAVI) is an established therapy for patients with severe aortic stenosis (AS). The aim of this study was to evaluate the newer-generation Portico TAVI system in an all-comers population. METHODS AND RESULTS: This single-centre study included 216 patients with severe AS (Society of Thoracic Surgeons [STS] score 4.3±3.0%). The Portico valve was implanted using the transfemoral (91.2%), transsubclavian (5.6%) and transcaval (3.2%) access. Device success was achieved in 94.4% of cases. At 30 days, mortality and stroke rates were 2.3% and 0.5%, respectively. Early safety was achieved in 91.7% of cases. More-than-mild paravalvular leak (PVL), as assessed by echocardiogram, was observed in 3.4% of the patients, with rates of 4.9% and 1.9% in the first and second half of the cohort, respectively. A permanent pacemaker was implanted in 15.8% of those without prior pacemaker, with a rate of 11.1% in the second half of the cohort. At one year, incidence rates for all-cause mortality and stroke were 12.3% and 2.3%, respectively. In the low-risk group (STS <4%; n=128), Kaplan-Meier estimates at 30 days and one year were 0% and 7.5% for all-cause mortality and 0.8% and 2.2% for stroke, respectively. Haemodynamic improvements persisted over time with a mean transvalvular gradient of 7.0±3.0 mmHg at one-year follow-up. CONCLUSIONS: The Portico TAVI system was safe to implant and achieved a high device success rate. With learning curve effects, the device achieves lower rates of PVL and pacemaker implantation and provides adequate clinical and haemodynamic outcomes up to one year.

Coronary artery disease, revascularization, and clinical outcomes in transcatheter aortic valve replacement: Real-world results from the East Denmark Heart Registry.

Transcatheter aortic valve replacement (TAVR) has become an established therapeutic option for patients with symptomatic, severe aortic stenosis. The optimal treatment strategy for concomitant coronary artery disease (CAD) has not been tested prospectively in a randomized clinical trial. This study aimed to describe the degree of CAD, revascularization strategies, and long-term clinical outcomes in a large-scale all-comers TAVR-population. Nine hundred and forty-four consecutive patients underwent TAVR. Obstructive CAD was reported in 224 patients (23.7%)-of these, 150 (66.9%) presented with one-vessel disease (1-VD), 51 (22.8%) with 2-VD, and 23 (10.3%) with 3-VD. Two-thirds underwent coronary revascularization before TAVR; half of those patients with 1-VD and only one-third of those with multivessel disease were completely revascularized. In general, borderline stenoses (50%-70%) were more frequently revascularized in proximal coronary segments than in more distal segments. Long-term survival rates by Kaplan-Meier analysis of the total TAVR population at 5 and 9 years were 64.7% and 54.1%, respectively. A diagnostic coronary angiography was performed in 16.5% of patients within 5 years after TAVR; only 4.8% underwent consequent percutaneous coronary intervention (PCI). There was no difference in survival and need for revascularization post-TAVR between those patients with or without obstructive CAD ± revascularization. Neither was there a survival difference between those with or without previous CABG and/or chronic total occlusion(s). In conclusion, CAD is prevalent in TAVR patients and pre-TAVR coronary revascularization is typically focused on treating proximal and high-grade stenosis. A selective pre-TAVR PCI strategy results in favorable clinical outcomes with very low rates of post-TAVR coronary revascularization.

A comparative study of different imaging modalities for successful percutaneous left atrial appendage closure.

OBJECTIVES: Accurate sizing of the left atrial appendage (LAA) is essential when performing percutaneous LAA closure. This study aimed to compare different LAA imaging modalities and sizing methods in order to obtain successful LAA closure. BACKGROUND: Percutaneous LAA closure is an increasingly used treatment strategy to prevent stroke in patients with atrial fibrillation. LAA sizing has typically been done by 2D-transoesophageal echocardiography (TEE). METHODS: Patients who had a preprocedural TEE and preprocedural and postprocedural multislice CT (MSCT) were identified. Preprocedural measurements of LAA ostia and landing zones by 2D-TEE, MSCT and angiography were collected and analysed for those patients with successful LAA closure - i.e. with no contrast leakage at 3-month follow-up MSCT. RESULTS: The study population (n=67) had a mean CHA2DS2-VASc score of 3.0 and HAS-BLED score of 2.7. Fifty-eight patients (87%) were identified to have successful LAA closure. Based on MSCT, 48 LAA sizings (83%) resulted in a correct LAA closure device size selection, whereas with 2D-TEE sizing, only 33 measurements (57%) would have resulted in a correct device size selection (p<0.01). Using adapted Bland-Altman method, MSCT-based perimeter-derived mean diameter was shown to be the best parameter to guide LAA device size selection for â€Ëœclosed-end’ devices (Amulet, WatchmanFLX), whereas the maximal diameter was the best parameter for the â€Ëœopen-end’ Watchman device. CONCLUSIONS: Preprocedural MSCT-based LAA closure device size selection proves to be a more accurate method than conventional 2D-TEE-based sizing. Depending on the LAA closure device design, perimeter-derived mean diameter or maximal diameter could be the better sizing method.

Acute Aortic Arch Perforation During Transcatheter Aortic Valve Replacement in Bicuspid Aortic Stenosis and a Gothic Aortic Arch.

Transcatheter aortic valve replacement (TAVR) has evolved from a novel technology to an established therapy for high/intermediate-risk patients with severe symptomatic aortic stenosis (AS). Although TAVR is used to treat bicuspid severe AS, the large randomized trials typically excluded bicuspid AS because of its unique anatomic features. This case report describes an acute aortic perforation during delivery of a transcatheter heart valve to treat a severe bicuspid AS with a "gothic aortic arch"; more careful evaluation of the preprocedural multislice computed tomographic scan would have unveiled a sharply angulated aortic arch. This life-threatening complication was successfully treated by thoracic endovascular aortic repair.