B P8 C78 Transcatheter Therapies for MV and TV Heart Disease

Question 1

Determining the morphology of the _____ is important in preprocedural planning for mitral balloon valvuloplasty (MBV)

Answer 1

Mitral valve

Subvalvular apparatus

Question 2

The suitability of a valve for MBV can be determined using a morphologic score; the most widely used is the system of Wilkins, which assigns a score of 1 to 4 for ______.

Answer 2

Leaflet mobility
Valve thickening
Calcification
Subvalvular thickening

Recently, the incorporation of additional echocardiographic measures including commissural calcification and asymmetry and leaflet displacement have allowed refinement and improved accuracy for predicting outcome.

Question 3

The severity of concomitant MR is also a key determining factor for MBV, both as it relates to the final result, which may increase up to ____ grade, and to confirm that the patient’s symptoms are indeed caused by valvular obstruction and not concomitant regurgitation

Answer 3

+1 grade

In the latter case, surgical mitral valve replacement may be a better option for symptomatic relief.

Question 4

_______ is a final step to assess further the severity of MR and valve morphology and to ensure the absence of left atrial (LA) thrombus before MBV.

Answer 4

Transesophageal echocardiography (TEE)

Question 5

MBV is indicated in symptomatic MS patients who have ______.

Answer 5

• At least moderate to severe MS
• Favorable valve morphology
• Absence of LA thrombus
• Less than moderate to severe MR

Question 6

In patients with rheumatic MS and calcified nonpliable valves who are at high risk or unsuitable for open surgery, _____ may be a reasonable alternative to provide _____.

Answer 6

MBV

Palliative symptomatic relief

Question 7

Class IIb recommendations for MBV in RMS

Answer 7

• MBV may also be considered in **asymptomatic **patients with moderate to severe MS and new-onset atrial fibrillation after excluding LA thrombus (class IIb).
• In patients with symptoms and mild MS(mitral valve area [MVA] >1.5 cm2), MBV can be considered if there is evidence of significant MS with exercise testing (class IIb)

Question 8

The mechanism of benefit of MBV is ______, which relieves the physical obstruction, thereby reducing the gradient and increasing MVA.

Answer 8

Separation of the fused commissures

Question 9

The ______ route is typically used to gain access to the left atrium to perform MBV

Answer 9

Transvenous antegrade transseptal route

Question 10

The _____ technique involves two peripheral arterial balloons tracked over separate guidewires placed in the left ventricle and simultaneously inflated.

Answer 10

Double-balloon technique

Question 11

The _____ technique has mostly replaced the double-balloon technique, in part because there is no risk of left ventricular (LV) perforation with the Inoue balloon

Answer 11

Inoue technique

Question 12

This system replicates the Alfieri stitch operation, in which the _______ are sutured together to create a double ­orifice mitral valve.

Answer 12

Middle scallops of the posterior and anterior leaflets (P2 and A2, respectively)

Question 13

It is important to evaluate carefully for severe commissural calcium preprocedurally. Calcium does not split with balloon inflation but does increase the potential for _____ the leaflets creating MR.

Answer 13

Tearing

Question 14

_____ are considered a successful result after MBV and can be achieved in more than 80% of appropriately selected patients

Answer 14

• Decrease in MVG by 50%
• Increase in MVA > 1.5 cm2

Question 15

An increase in MR by more than _____ grade after balloon inflation should signal an end to the procedure despite a residual gradient.

Event-free survival after MBV is influenced by valve morphology.

Answer 15

> 1 grade

Question 16

In multivariate analysis, _____ were all independently associated with worse outcome at follow-up after MBV

Answer 16

Age
Post-MBV MR grade of 3+ or higher
Prior surgical commissurotomy
NYHA Class IV symptoms
Elevated post-MBV PASP

Question 17

The most common complication from MBV, ________, occurs in 2% to 10% of patients, with no significant difference between the Inoue and double-balloon techniques.

Overall procedural mortality is approximately 1%.

Answer 17

Severe MR

Other, less common procedural complications include pericardial tamponade, embolic events, vascular complications, arrhythmias, bleeding, stroke, myocardial infarction, residual atrial septal defect, and LV perforation.

Question 18

____ is considered the gold standard, and 3D TEE has been shown to be superior to TTE in reducing fluoroscopy time and the interval from first transseptal puncture to first balloon inflation

Answer 18

TEE

Question 19

In asymptomatic patients with primary MR and preserved LV function, a _____ approach can be considered until the development of ______, and current guidelines recommend surgery in patients who have reached these endpoints.

Surgery may also be considered for asymptomatic patients with normal LV function in whom there is a high likelihood of successful mitral valve repair.

Answer 19

Asymptomatic: “watchful waiting” or “active surveillance”

Surgery in those with:
Pulmonary hypertension
LV dysfunction
Atrial fibrillation
Symptoms

Question 20

______ was the first transcatheter mitral valve repair technology to receive CE (Conformité Européenne) Mark approval (European Union) and has now also received FDA approval for patients with primary (degenerative) MR and prohibitive surgical risk as well as for heart failure patients with left ventricular dysfunction (secondary MR) despite optimal medical therapy

Answer 20

MitraClip (Abbott Vascular)

This system replicates the Alfieri stitch operation, in which the middle scallops of the posterior and anterior leaflets (P2 and A2, respectively) are sutured together to create a double-orifice mitral valve. The operation, although usually performed with adjunctive ring annuloplasty, has proved effective and durable in a wide variety of pathologies as well as in select patients without annuloplasty.

Question 21

Identify the trial

Evaluated the safety and feasibility of percutaneous mitral valve repair using the Edge-to-Edge technique in patients with moderate or severe mitral regurgitation (MR).

Included symptomatic moderate to severe or severe MR or asymptomatic moderate to severe or severe MR with left ventricular dysfunction and age ≥18 years; candidate for mitral valve surgery

Answer 21

EVEREST I trial
(Endovascular Valve Edge-to-Edge Repair Study [EVEREST] I)

Among patients with moderate or severe MR, percutaneous mitral valve repair using the Edge-to-Edge technique was feasible and appeared relatively safe in the first 27 patients enrolled in the study.

At 30 days, 85% of patients met the criteria for freedom from MAE. Of the 15% of patients with a MAE (4/27), 1 patient had a stroke and 3 patients had clip detachment. Mean MR was reduced from 3.7 at baseline to 1.6 at discharge and 2.1 at one month follow-up. Among the 24 patients with clip implanted, 25% underwent surgery an average of 1.7 months after the initial procedure, and 75% were surgery free. In 18 surgery-free clip patients, mean New York Heart Association heart failure classification improved in 72% of patients (n=13) and was unchanged in 28% (n=5).

Question 22

Identify the trial

Evaluated treatment with the percutaneous MitraClip device compared with surgical mitral valve repair/replacement among patients with severe mitral regurgitation.

Major adverse events at 30 days were significantly less frequent with MitraClip therapy (9.6% versus 57% with surgery; P < 0.0001), although much of the difference could be attributed to the greater need for blood transfusions with surgery.

Answer 22

EVEREST II trial

Among patients with severe mitral regurgitation, repair with a percutaneous mitral valve clip is feasible. This therapy demonstrated improved safety at 30 days compared with surgery, largely by reducing the need for blood transfusion.

The primary effectiveness outcome favored surgery at 1 year due to more complete resolution of mitral regurgitation.

However, beyond 1 year, the need for surgery or moderate to severe mitral regurgitation was similar between the groups.

Left ventricular dimension was reduced to a similar degree in both groups, although ejection fraction declined by a greater extent in the surgical group. Among high-risk patients with functional mitral regurgitation, percutaneous mitral valve repair significantly reduced mitral regurgitation and improved clinical symptoms.

Question 23

Identify the trial

Assessed the safety and efficacy of transcatheter mitral leaflet approximation using MitraClip among symptomatic heart failure (HF) patients with secondary mitral regurgitation (MR)

Patients with HF and grade 3-4+ MR who remained symptomatic despite maximally tolerated guideline-directed medical therapy (GDMT) were randomized to MitraClip + GDMT (n = 302) vs. GDMT alone (n = 312)

Answer 23

COAPT trial
Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation

The results of this landmark trial indicate that transcatheter mitral valve approximation using the MitraClip on a background of maximally tolerated GDMT was superior to GDMT alone in reducing HF hospitalization and mortality in symptomatic HF patients with grade 3-4+ MR. Improvements were also observed in LV dimensions, renal outcomes, hospitalizations (primarily related to HF, both fatal and nonfatal), and patient symptoms

Question 24

Identify the trial

Evaluated percutaneous mitral valve repair (MitraClip) compared with medical therapy among patients with severe functional mitral regurgitation

Patients with severe secondary mitral regurgitation were randomized to percutaneous mitral valve repair (n = 152) versus medical therapy (n = 152)

Answer 24

MITRA-FR trial
Percutaneous Repair With the MitraClip Device for Severe Functional/Secondary Mitral Regurgitation

Among patients with severe secondary mitral regurgitation, percutaneous mitral regurgitation repair (MitraClip) was not beneficial. The MitraClip device was not associated with a reduction in the composite (or individual components) of death or hospitalization for heart failure. The MitraClip device was effective since 92% of patients experienced a reduction in mitral regurgitation of at least 2 grades; however, follow-up echocardiographic data were incompletely reported. The lack of benefit was likely due to the poor prognosis of the severe underlying cardiomyopathy.

This trial contrasts with the COAPT trial, which documented benefit from MitraClip therapy for secondary mitral regurgitation. One reason postulated for this difference is that patients in COAPT had more mitral regurgitation per unit of ventricular volume (i.e., disproportionate mitral regurgitation). In COAPT, the mean EROA was 41 mm2 and the mean LVEDV was 194 cc versus MITRA-FR, where the mean EROA was 31 mm2 and the mean LVEDV was 272 cc.

Randomization for COAPT occurred only after aggressive GDMT was achieved, including CRT as indicated, and stable for 3 months, and the primary efficacy outcome was rehospitalization for heart failure within 24 months; a relatively low percent of patients received ARB or ARNI therapy.

Randomization for the MITRA-FR trial, however, occurred after identification of appropriate LVEF and MR criteria, and GDMT could continue to be fine-tuned during the course of the trial for both randomized cohorts; and a higher percentage of patients in both arms were treated with RAAS blockers.

Question 25

More recently, a redesigned device was tested in the _____ trial. Among 65 patients with secondary MR (62% ischemic), the device was implanted successfully in 36 patients, with a mean age of 62 years, mean ejection fraction (EF) of 29%, predominantly NYHA Functional Class III symptoms, and 2+ (30%), 3+ (55%), or 4+ (15%) grade MR. Quantitative measures of MR were better at 6 and 12 months than in 17 patients who did not receive implants

Answer 25

TITAN (Transcatheter Implantation of Carillon Mitral Annuloplasty Device) Trial